cyrilzakka/clinical-trials huggingface dataset:
Pseudo Continent Perineal Colostomy vs Permanent Left Iliac Colostomy After Abdominoperineal Resection for Ultra Low Rectal Adenocarcinoma

Aim of this study is to compare the cost-effectiveness and the quality of life in the 6 months following the surgery of a pseudo continent perineal colostomy (PCPC) and a permanent left iliac colostomy (PLIC) following an abdominoperineal resection (APR) for ultra low rectal cancer

The surgical treatment of ultra low rectal adenocarcinoma has known great changes, yet the abdominoperineal resection (APR) is still indicated in over 20% of these cases.

A permanent left abdominal stoma is the standard salvage technique.

The pseudo continent perineal colostomy (PCPC) is an alternative technique especially in low income countries where the stoma bag and stoma care is not covered by health insurances.

Furthermore, this technique allows the conservation of body image, which is frequently requested by muslim patients whenever it is possible.

The aim of this study is to compare the cost effectiveness of both techniques as well as the quality of life of patients in the 6 first months following the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients of 18 years old or above
* Abdominoperineal resection for ultra low rectal cancer
* Creation of a definitive iliac colostomy or a pseudo continent perineal colostomy
* Patients willing to participate to this study (writting consent)

Exclusion Criteria:

-Patients unable to respond to the Quality Of Life questionnaires
Comparison of High Intensity Strength Training and Muscle Energy Techniques in TKR Patients

Globally, the prevalence of total joint replacement (TKR) procedures has been rising, providing patients with better joint function, decreased pain, and enhanced quality of life. A thorough and successful postoperative rehabilitation program, which attempts to restore optimal function and lower the risk of problems related to the treatment, is necessary for the success of total knee replacement (TKR) procedures. After total knee replacement, postoperative rehabilitation is a crucial stage in the patient's healing process. Normal knee function is frequently hampered by issues like pain management, muscular weakness, joint stiffness, and proprioceptive deficiencies. Therefore, choosing a suitable rehabilitation regimen is crucial.

The main objective of this study is to compare two different rehabilitation strategies: Muscle Energy Techniques with Balance Exercises and High Intensity Strength Training with Balance Exercises. The research aims to maximize postoperative results for patients who have undergone total knee replacement surgery.

The focus on resistance exercises intended to improve muscle strength and power is what defines high intensity strength training, or HIST. Research has indicated that HIST is beneficial in enhancing joint stability, muscle function, and overall functional outcomes across a range of orthopedic groups. Its precise use and effect on patients recovering from TKR surgery, however, need further investigation. In order to increase joint mobility, lessen pain, and improve neuromuscular control, patients who get Muscle Energy Techniques (MET) actively participate in targeted muscle contractions. MET has demonstrated potential in treating muscular imbalances.

Eligibility Criteria:
Inclusion Criteria:

* Individuals between the ages of 45 and 75
* Patients should be within a certain timeframe following surgery (e.g., post op day 0-day) to ensure homogeneity throughout the rehabilitation phase.
* Patients who have had primary total knee replacement
* To take part in the RCT, participants must give informed consent
* they must be able and willing to follow the study protocol's instructions for post-rehabilitation care.

Exclusion Criteria:

* Comorbidities: Individuals with significant comorbidities affecting rehabilitation, such as severe cardiovascular disease or neuromuscular disorders, may be excluded.
* Allergies/Contraindications: Patients with allergies or contraindications to specific exercises or techniques used in the study.
* Inadequate Cognitive Function: Participants with cognitive impairments that prevent them from comprehending and adhering to the rehabilitation protocols.
* Other Knee Surgeries: Patients who have had other knee surgeries or have had bilateral knee replacements may be excluded due to variations in recovery and rehabilitation.
Study Using Spray Skin Protector Versus Conventional Treatment to Prevent Acute Radiodermatitis.

This is a randomized, open-label, single-institution trial designed to evaluate the effectiveness of a spray skin protector in preventing moist desquamation caused by radiotherapy treatment.

This technology, spray skin protection, depending on the manufacturer, is primarily intended to prevent or reduce contact dermatitis. However, this study will be evaluated for use in preventing moist desquamation caused by ionizing radiation. The comparing agent will be a moisturizer, agreed upon at the local Institution of the study for use in the prevention of radiodermatitis. As secondary objectives: describe adverse events, diarrhea, pain and pruritus.

The study will be conducted at the radiotherapy outpatient clinic of the Cancer Hospital I (HCI) of National Cancer Institute (INCA) in Brazil.

The hypotheses are:

Null (Ho): The incidence of moist desquamation with the spray skin protector is greater than or equal to the incidence of moist desquamation in the control group.

Alternative (H1): The incidence of moist desquamation with the spray skin protector is lower than the incidence of moist desquamation in the control group.

The evaluation of the skin of the participants will be weekly, with blinding of this professional. For the evaluation of secondary objectives, adverse events will be applied in the assessment scales of diarrhea, pruritus and pain by the CTCAE version 5.0; and the burning or burning sensation will be recorded only.

Eligibility Criteria:
Inclusion Criteria: patients with anal and rectal cancer with indication for radiotherapy and conventional fractionation of treatment in a linear accelerator; age \> or = 18 years; no previous history of radiotherapy in the same field/site of treatment (reirradiation).

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Exclusion Criteria:patients with pre-existing irradiated dermatitis, which makes skin assessment difficult; previous report of allergic reaction to any of the products used in the research.

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Safety and Efficacy of Emergency On-call Respiratory Physiotherapy Services in the Paediatric Intensive Care Unit

Emergency on-call respiratory physiotherapy cover for children in intensive care is frequently provided by physiotherapists who ordinarily work in non-respiratory areas. This has produced concerns about the safety and efficacy of on-call treatments and is widely recognised as an important clinical governance issue affecting services throughout the National Health Service (NHS).

The aim of this study is to investigate whether emergency on-call respiratory physiotherapy services provided in the paediatric intensive care unit (ICU) are safe and effective. Further it will explore whether there are any quantifiable differences between specialist and on-call physiotherapy treatments.

The study is a randomised, cross-over study design. Infants and children who are likely to require at least 2 physiotherapy treatments in one day are recruited to the study. Both physiotherapy airway clearance treatments are administered during a 12 hour period, with at least 2 hours between treatments. One is administered by a respiratory physiotherapist who works regularly in the ICU and one by a physiotherapist on the on-call rota, who normally practises in a non-respiratory clinical area. Treatments are performed in a randomised order and outcomes measured before, during and after treatments.

Physiotherapy staff who consent to participate in the study include:

Specialist respiratory physiotherapists who regularly work in the ICU Non-respiratory physiotherapists on the on-call rota who normally work in a non-respiratory areas but cover the ICU overnight and at weekends.

Patients include:

the study aims to recruit 80 infants and children (ages 0 to 16 years), who are in the paediatric intensive care unit and

1. Require full mechanical ventilation and are well sedated
2. Are likely to require at least two physiotherapy treatments within the day of the study (assessed by an independent senior respiratory physiotherapist) and
3. Whose parents or carers consent for them to participate in the study. Respiratory mechanics, arterial blood gases, oxygen saturation and peak pressures are recorded before and after each intervention Forces applied during manual techniques, flow, pressure and volume during manual lung inflations, volume of saline and selection and order of treatment components are recorded during treatments Adverse events occurring during or up to 30 minutes after physiotherapy are also recorded.


Eligibility Criteria:
Inclusion Criteria:

* infants and children who are well sedated and mechanically ventilated and likely to require at least 2 physiotherapy interventions over the course of a single day

Exclusion Criteria:

* patients in whom the application of manual techniques is contra-indicated
Health-promoting Competence, Coping and Quality of Life in Patients With COPD

Chronic obstructive pulmonary disease (COPD) is a major cause of mortality and disability, and by 2020, it is expected to be the third leading cause of mortality worldwide. COPD is a major public health concern and has considerable impact on health and quality of life.

For this study an evidence based self-management program is developed, the purpose of the study is to see if this self-management program, in collaboration between specialized health services and municipality health services, improves patients with COPD health-promoting competence, coping and quality of life, and reduces health service costs.The study has a RCT design.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD, GOLD 2-4
* Speak and understand norwegian
* Adult

Exclusion Criteria:

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A Intra-patient Comparison of Closed Loop and Plate Haptic Toric Intraocular Lenses

During cataract surgery an artificial lens is implanted in the eye. These artificial lenses are called intraocular lenses (IOLs) and there are many different types of IOL designs. Your eyes have astigmatism, which is a normal and common characteristic of the eye. If left uncorrected the astigmatism would mean that you would need to wear spectacles for viewing distance objects. New IOL designs called toric IOLs help to correct the astigmatism to improve your vision after cataract surgery. This study has been designed to look at how well a toric IOL corrects this astigmatism so that you do not need to wear spectacles for viewing distance objects. There are many designs of these toric IOLs and for this study we are looking to compare two different designs of toric IOLs by putting one lens in your right eye and a different type of lens in your left eye. Both lenses are commercially available and are commonly implanted IOLs. Using new non-invasive methods we hope to be able to better judge the visual performance of these lenses and the ability of these lenses to correct astigmatism. In addition the study will involve imaging and examining the IOLs to determine the prevalence of any post-operative complications.


Eligibility Criteria:
Inclusion Criteria:

* Age 50-75 years, bilateral significant corneal astigmatism \>1.50D.
* Requiring a Toric IOL within the following power range:
* Sphere +6.00D to +30.00D
* Cylinder +1.00D to +6.00D

Exclusion Criteria:

* Amblyopia,
* predicted bilateral post-op corneal astigmatism of \<1.50D,
* irregular astigmatism,
* dilated pupil size smaller than 5mm,
* macular pathology,
* glaucoma,
* retinal disease,
* corneal disease,
* abnormal iris,
* pupil deformation and
* any previous corneal or intraocular surgery.
Glycogen Storage Disease Type Ia (GSDIa) Disease Monitoring Program

The main objective of this observational study is to evaluate the long-term safety and effectiveness of DTX401 for at least 10 years after DTX401 administration.

The DTX401-CL401 Disease Monitoring Program (DMP) is a prospective, multicenter, long-term observational study to follow up participants with GSDIa for at least 10 years after the administration of DTX401.

Eligibility Criteria:
Inclusion Criteria:

* Patient who had:

  * DTX401 (full or partial dose) administered in a parent clinical study (Group 1) or
  * Prescribed DTX401(full or partial dose) administered in a post-marketing setting (Group 2)
* Patient is willing and able to provide informed consent after the nature of the study has been explained, and prior to any research-related assessments or procedures. If a minor or an adult with cognitive limitations, the patient is willing and able (if possible) to provide assent and have a legally authorized representative provide informed consent after the nature of the study has been explained, and prior to any research-related assessments or procedures.

Exclusion Criteria:

* Presence of any condition that would interfere with study participation, interpretation of results or affect patient's safety in the opinion of the Investigator
The Effect of Scent on Pregnancy Induced Nausea, Vomiting, and Quality of Life

This study evaluates the effects of essential oils on nausea, vomiting, and quality of life scores among pregnant women. Participants will receive either an essential oil roll-on product or a placebo product to apply to their temples and jaw line daily for 6 days.

The inhalation of certain essential oils has been found to reduce feelings of nausea and to improve quality of life during pregnancy.

The essential oils used in this study are applied topically to the temples and jaw line every 4-6 waking hours over a 6-day period. Each application will produce an exposure that lasts up to 30-45 minutes before fading. At the end of each day, nausea and vomiting levels will be assessed using a validated measurement instrument.

Quality of life is measured using a 30-question tool that measures both pregnancy-related quality of life and pregnancy-induced nausea and vomiting.

Eligibility Criteria:
Inclusion Criteria:

* age: 18-45 years
* confirmed pregnancy
* healthy pregnancy

Exclusion Criteria:

* hyperemesis gravidarum
* tobacco use in the home
* high risk pregnancy
Efficacy of Pulmonary Vein Isolation Alone in Patients With Persistent Atrial Fibrillation

This study examines non-inferiority of pulmonary vein isolation (PVI) for persistent atrial fibrillation (AF) to extensive ablation; and reveals the effect of the presence or origin of AF trigger on outcomes of catheter ablation.

Study design The EARNEST-PVI trial is a prospective, multicenter, randomized, open-label non-inferiority trial in which patients with persistent AF will undergo ablation. After providing written informed consent at each hospital, patients who are eligible for the trial will be randomized to either PVI alone or PVI plus additional ablation. Left atrial dimensions will be the only adjustment factor considered in dynamic allocation to avoid bias. Patients randomized to the PVI alone group will be treated with PVI, while patients randomized to the PVI plus additional ablation group will receive additional complex fractionated atrial electrogram or linear ablation after PVI. Ablation for AF triggers from non-PV foci, the cavotricuspid isthmus, clinical coexisting tachyarrhythmia such as atrial flutter (AFL), atrial tachycardia (AT), and supraventricular tachycardia will be allowed in both groups. Patients will be followed up 1, 3, 6, 9, and 12 months after the procedure. The primary endpoint of the study is the recurrence of AF documented by scheduled or symptom-driven ECG during 1 year after the procedure. "Recurrence of AF" is defined as the documentation of any atrial arrhythmia including AF, AFL, and/or AT lasting ≥ 30 seconds by ECG or other appropriate tests. The sample size and randomization are specified based on the concept of non-inferiority to achieve the primary objective. The recurrence rate of AF was assumed to be 40% in both groups and a non-inferiority margin of 10% was calculated by referring to the previous studies. Therefore, a sample size of 256 subjects in each group is required with a power of 80% and significance level of 5% considering some dropouts. The statistical evaluation will be carried out according to the intention-to-treat principle.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a first-time ablation procedure for persistent AF

Exclusion Criteria:

* Patients with long-standing persistent AF lasting ≥ 5 years
* Patients with left atrial dimension ≥ 50 mm by 2-dimensional echocardiography
* Patients with valvular AF (defined as the presence of mitral or aortic stenosis or regurgitation with a history of rheumatic fever or implantation of artificial heart valves)
* Patients who underwent prior cardiac surgery
* Patients receiving hemodialysis
* Patients with heart failure (left ventricular ejection fraction \< 30% and NYHA class ≥ III)
* Patients receiving antiarrhythmic agents before the ablation procedure (within 60 days for amiodarone, or 5 half-lives for other drugs)
* Patients who are not considered to be suitable candidates by the attending physician
Acute Undifferentiated Fever in Ethiopia

A cross-sectional study on acute undifferentiated fever and the utility of biomarkers in differentiating bacterial from viral infection among acute febrile patients in Gondar, northwest Ethiopia.

General objective:

To assess the causes of acute undifferentiated febrile illness and evaluation of biomarkers for differentiation of bacterial and viral infections among outpatients at University of Gondar (UOG) Hospital, Northwest Ethiopia

Specific objectives

1. To determine the number of malaria cases, bacterial infections (by blood culture and polymearase chain reaction (PCR) for Rickettsia and Borrelia), and arboviral infections (DENV, YFV, CHIKV) among all acute febrile patients
2. To evaluate the diagnostic performance different assays (RDT, RT-(reverse transcriptase)PCR, ELISA) for the diagnosis of DENV
3. To evaluate the qualitative detection of C-reactive protein (CRP) and Myxovirus resistance protein (MxA) (by FebriDx RDT) and quantitative CRP detection for differentiating bacterial and viral infections

Study design, population, materials and methods: a cross-sectional cohort study on febrile patients presenting with acute fever at the emergency ward of the UOG hospital from June to August 2019. Clinical and epidemiological data will be recorded in a pseudo-anonymized and collected using an electronic data collection tool (KoBoToolbox). Blood will be collected for RDT testing, blood culture, PCR and serum for ELISA and RT-PCR.

Sample size: 200 acute febrile patients

Expected results and relevance: Evaluation of the causes of acute febrile illness and the role of biomarkers in differentiating viral and bacterial infections will increase the awareness of circulating pathogens and improve patient management. This evidence will contribute to a more rational use of laboratory diagnostic tests, antibiotics and antimalarial treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with acute fever (an axillary temperature of ≥37.5°C; symptom duration ≤7 days)
* ≥ 15 years old
* signed informed consent

Exclusion Criteria:

* pregnant woman \& children (\<15 y)
* febrile patient suspected of urinary tract infection or acute respiratory tract infection
* Individuals who had taken antimicrobial and antimalarial drug in the last 2 weeks
* Patients with acute injury or trauma or for which participation in the study implies an unacceptable health risk as determined by the physicians
Micro RNA Genetic Signature in NSCLC Egyptian Patients

This study will be carried out on 40 subjects at Chest department Tanta university hospital

The subjects will be classified into three groups:

* Group I: will include ten non smoker volunteers (control group I).
* GroupII: will include ten smoker volunteers (control groupII).
* Group III: will include twenty NSCLC patients confirmed by pathological examination of bronchoalveolar examination (BAL), brush and/or biopsy.

The patients and control groups will be subjected to the following:

* Complete history taking and complete general examination.
* Complete chest examination.
* Radiological assessment including chest x ray (posteroanterior and lateral view).
* Computed tomography (CT) chest for all patients in group III and when needed in group I and II.
* Laboratory investigations:

  * Complete blood picture
  * Fasting and post parandial blood sugar level
  * liver function tests
  * kidney function tests (urea and creatinine).
  * Prothrombine time and activity.
  * Zeil-Neelsen staining of sputum.
  * Tumour markers including α Fetoprotein, Carcino Embryonic antigen (CEA), CA19-9, CA 125, CA15-3 and others.
* Venous blood samples will be collected from peripheral blood (5 ml) under complete aseptic technique. Serum samples will be obtained by centrifugation. Isolation of total RNA from serum pools will be performed. RNA profiles and quantification will be assessed using Microarray.
* Lung biopsy either transbronchial via bronchoscopy or peripherally via ultrasound , CT guided, thoracoscopy or open lung biopsy will be performed with isolation of total RNA from lung tissue biopsy. RNA profiles and quantification will be assessed using Microarray.
* Bronchoalveolar lavage will be performed with isolation of total RNA from it. RNA profiles will be assessed using Microarray.

Ethical considerations:

1. Informed consent will be taken from all subject's and include:

   A. The aim of research. B. All data are confidential. C. All data will be used in research only.
2. For patient's privacy:

   A. There will be a code number for each patient in special folder. B. The results of research will be used in scientific publishing only.
3. Unexpected risks that appear during the courses of research will be cleared to the participants and the ethical committee on time.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for patients:

Non small cell lung cancer patients recently diagnosed who did not receive chemotherapy, surgery or radiation therapy.

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Exclusion Criteria:

* Exclusion criteria for patients:
* Diagnosis of asthma or COPD.
* Broncheiactasis.
* upper/lower respiratory tract infection in the preceding 4 weeks.
* Active pulmonary tuberculosis.
* Associated cancer beside lung cancer.
* Patients who received chemotherapy, surgery or radiation therapy previous to the sample collection.

Exclusion criteria for control subjects:

* Diagnosis of asthma or COPD.
* Broncheiactasis.
* Upper/lower respiratory tract infection in the preceding 4 weeks.
* Active pulmonary tuberculosis
* Smoking in group I.
A Study To Evaluate The Efficacy Of Enbrel (REGISTERED) Etanercept Over A Period Of 12 Months In The Routine Treatment Of Patients With Rheumatoid Arthritis, Axial Spondyloarthritis, Psoriatic Arthritis, Or Plaque Psoriasis.

The purpose of this non-interventional study is to evaluate the efficacy of etanercept during routine clinical use over a maximum of 12 months in patients with rheumatoid arthritis (RA), psoriatic arthritis(PsA), axial spondyloarthritis(axSpA) or plaque psoriasis (PsO). In so doing, particular attention will be paid to the proportion of those patients who only attain the desired treatment goal after 12 weeks of treatment. The primary efficacy end point for the study is the proportion of patients who attain the desired treatment goal after 12 and 24 weeks,


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of RA, axSpA, PsA or PsO
* No prior treatment with etanercept and eligibility for treatment with etanercept according to the summary of product characteristics.

Exclusion Criteria:

* The contraindications, special warnings, and precautions according to the summary of product characteristics for etanercept shall apply.
* The additional documentation of the patient in another post-marketing study with etanercept is not permitted.