cyrilzakka/clinical-trials huggingface dataset:
DEVELOPMENT OF A CLINICAL PREDICTION RULES TO IDENTIFY EFFICACY OF PULSED ELECTROMAGNETIC THERAPY ON BURN WOUND HEALING

The purpose of this study is to investigate whether patients' age, total burned surface area, wound stage and wound depth determine wound healing response to pulsed electromagnetic therapy in burn patients

It will be hypothesized that

1. Age may significantly affect burn wound healing's response to pulsed electromagnetic waves.
2. TBSA may significantly affect burn wound healing's response to pulsed electromagnetic waves
3. Depth of wound may significantly affect burn wound healing's response to pulsed electromagnetic waves
4. Wound healing stage may significantly affect burn wound healing's response to pulsed electromagnetic waves This study will be conducted at the in-patient burn units. There will be only one intervention group. The duration of the study will be 6 weeks divided to 18 sessions (three sessions per week). Sixty patients (male and female) will be recruited from the burn units.

Pulsed electromagnetic waves will be performed for 60 min 3 times per week till healing (maximum 8 weeks) on the wound area.

PEMF therapy will be as (duration: 60 minutes; frequency: 12 Hz; intensity: 12 Gauss)

Eligibility Criteria:
Inclusion Criteria Partial thickness Burn wound depth. Age ranges from 20-50 years. TBSA more than 15% Sufficient understanding to perform the tests. Exclusion Criteria Diabetic patients. Patients receiving immunosuppressive drugs. Associated co-morbidities, such as neurological diseases, malnutrition, and other inﬂammatory and/or infectious diseases.
Effects of High Intensity Interval Training and Strength Training in Obese

Obesity is a global health problem since it is associated with many cardiovascular and metabolic diseases, osteoarticular problems and some cancers. That is why it is a priority of the national health policies. Exercise is a mainstay in the treatment, but still the most effective method is sought. The resistance exercise and high intensity intervals (HIIT) have been shown to positively affect the outcome of the disease, increasing the oxidative capacity of the trained subjects. Therefore it is important to look if both together produce greater benefits or otherwise nullify its effects, such as suggested by recent publications in relation to the cellular response to different stimuli such exercise in skeletal muscle. The aim of this study is to evaluate the effectiveness of interventions exercise high intensity intervals, overload and combining them in the oxidative capacity of obese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Indication of medical supervised exercise
* BMI of 25-35kg/m2
* Participate in a 10 session rehabilitation program

Exclusion Criteria:

* Osteomuscular injuries
* Cardiovascular disease without control
* Bariatric Surgery
* High blood pressure without control
Progressive Relaxation Exercise on Pain, Anxiety and Patient Satisfaction

This single-center, prospective, randomized controlled trial was completed with a total of 70 patients, 35 in each of the intervention and control groups. Data were collected using the Patient Information Form, Visual Analogy Scale and State-Trait Anxiety Inventory. Patients in the intervention group performed progressive relaxation exercise for 20 minutes before femoral sheath removal. The patients in the control group received the standard practice of the clinic.

This study aimed to determine the effect of progressive relaxation exercise (PRE) applied to patients undergoing percutaneous coronary intervention (PCI) on pain, anxiety and patient satisfaction related to femoral sheath removal. This single-center, prospective, randomized controlled trial was completed with a total of 70 patients, 35 in each of the intervention and control groups. Data were collected using the Patient Information Form, Visual Analogy Scale and State-Trait Anxiety Inventory. Patients in the intervention group performed PRE for 20 minutes before femoral sheath removal. The patients in the control group received the standard practice of the clinic.

Eligibility Criteria:
Inclusion Criteria:

* able to speak and understand Turkish,
* over 18 years of age,
* intervened in the femoral region,
* with only one catheter in the femoral region,
* without vision and hearing problems,
* undergoing angiography procedure for the first time,
* with normal vital signs,
* who have not been administered analgesics for any reason prior to sheath removal after the procedure,
* patients who volunteered to participate in the study were included in the study.

Exclusion Criteria:

* patients with chronic pain using transdermal patches,
* patients with impaired time and place orientation,
* patients with psychiatric disorders.
Correlation of Preoperative Indices (serum Vit D, Calcium, Phosphorus, FAR, PLR, SII) on Intraoperative Bleeding in CRS

The purpose of this observational study was to examine whether preoperative indicators correlate with intraoperative bleeding to facilitate control of intraoperative bleeding.

In this study, we analysed the effect of preoperative inflammation on intraoperative haemorrhage at the subjective and objective levels by measuring a number of indicators (including Vit D, Ca, P, and some ratios) in the blood specimens and by three scales.Blood test indicators can be obtained from routine tests.Three scales were obtained by the researcher after interviewing the patients, Symptom Score (0-15), where higher scores indicate more severe symptoms, Lund-Kennedy Score (0-6), where higher scores indicate higher levels of localised inflammation, Lund-Mackay Score (0-12 unilaterally and 24 bilaterally), where higher scores indicate higher levels of inflammation, and Lund-Mackay Score (0-12 unilaterally and 24 bilaterally), where higher scores indicate higher levels of inflammation.Lund-Mackay score (0-12 unilaterally, 24 bilaterally), where higher scores represent higher levels of inflammation.Final correlation of blood test indices and three scale scores with intraoperative.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of chronic rhinosinusitis

Exclusion Criteria:

Sinus cyst Upper respiratory tract infection in the last 1 week Use of antiepileptic drugs Use of aspirin Use of anticoagulant or antiplatelet drugs
Mesotherapy Treatment of Irritable Bowel Syndrome

Irritable bowel syndrome (IBS) is a gastrointestinal transit disorder characterized by chronic abdominal pain and impaired transit in the absence of demonstrated organic disease. Considered a non-fatal disease, its effects relate more to quality of life, work production and health care systems.

Given the complexity of this disease, no treatment has been recognized as standard treatment. The treatment is rather focused on treating the symptoms caused (chronic pain or intestinal transit disorder). In general, therapy is considered individualized and includes lifestyle/diet modifications and pharmaceutical therapy.

Several published case studies evaluating the effect of mesotherapy on improving the severity of the disease have demonstrated an improvement in the symptoms of this syndrome. Due to the limited number of case studies and the insufficient level of evidence to conclude, our study will therefore be a before-and-after intervention study, to evaluate the effect of four mesotherapy sessions on the treatment of IBS symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Patient suffering from Irritable Bowel Syndrome according to the Rome IV criteria, whose diagnosis was made by a specialist in Hepato-Gastro-Enterology,
* Francis score \>75/500, i.e. minimal, moderate or severe severity,
* Patient who has failed conventional treatment (treatment followed for at least 1 year and not showing an improvement in symptoms)
* Absence of risk of ongoing pregnancy in women of childbearing age, validated by a urine test during the first consultation and before treatment and each month during treatment and until 1 month after the end of treatment

Exclusion Criteria:

* Patient with the following medical history or current pathologies: organic gastrointestinal pathology, disabling neurological pathology, disabling psychiatric pathology
* Recent Post Traumatic Stress Syndrome (\<1 year),
* Fibromyalgia syndrome,
* Known allergy to medications used in mesotherapy treatment,
* Pregnant or breastfeeding woman
Teriflunomide for Steroid-resistant/Relapse Immune Thrombocytopenia

Single-arm, open-label, single-center study to evaluate the efficacy and safety of teriflunomide for the treatment of adults with steroid-resistant/relapse immune thrombocytopenia (ITP).

This is a prospective, single-arm, open-label study of teriflunomide in approximately 40 patients with ITP who have relapsed or have an insufficient response to prior therapies. Teriflunomide is administered as 7 mg orally once daily with dose adjustments for 24 weeks. Efficacy and safety outcomes are assessed on scheduled study visits.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of primary immune thrombocytopenia (ITP) by excluding other supervened causes of thrombocytopenia
2. Patients with a platelet count \<30,000/μL or a platelet count \<50,000/μL with bleeding manifestations at the enrollment;
3. Patients who did not achieve a sustained response to treatment with full-dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid tapering or after its discontinuation;
4. Willing and able to sign written informed consent.

Exclusion Criteria:

1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit;
2. Secondary immune thrombocytopenia (e.g. patients with HIV, HCV, Helicobacter pylori infection, malignancy, or patients with confirmed autoimmune disease);
3. Pregnancy or lactation;
4. Pre-existing acute or chronic liver disease, or serum alanine aminotransferase (ALT) greater than 2 times the upper limit of normal (ULN);
5. Current or recent (\< 4 weeks prior to screening) clinically serious viral, bacterial, fungal, or parasitic infection;
6. Have evidence of active tuberculosis (TB), or have previously had evidence of active TB and did not receive appropriate and documented treatment, or have had household contact with a person with active TB and did not receive appropriate and documented prophylaxis for TB;
7. Patients who are deemed unsuitable for the study by the investigator.
Hypofractionated Intensity Modulated and Image Guided Radiotherapy for Localized Prostate Cancer

Hypofractionated intensity modulated and image guided radiotherapy (HypoIGRT) with fewer high-fraction-size treatments would be beneficial for prostate cancer because it would deliver a larger biological-equivalent dose to the tumor than would conventional treatment in 1.8-2.0 Gy fractions, while maintaining a similar or lower incidence of late normal tissue reactions. Thus, the investigators aim to assess the hypothesis that HypoIGRT treatment for localized prostate cancer will improve the therapeutic ratio by either:

1. Reducing normal tissue, mainly genitourinary and gastrointestinal, toxicity and / or
2. Improving tumour control, mainly freedom from biochemical failure survival.

The investigator chose to study a HypoIGRT regimen, in participants with prostate adenocarcinoma, tumor which is considered to present a low α / β, and therefore benefit from this approach.

Primary Outcome Measures:

1. Acute and late radiation induced toxicities.

Secondary Outcome Measures:

1. Freedom from prostate cancer recurrence - freedom from biochemical failure survival;
2. Cause specific and overall survival
3. Aspects of quality of life and health economics

Study Design:

Allocation: Prospective allocation Endpoint Classification: Feasibility Study (Toxicity assessment) Intervention Model: Single Assignment Masking: Open Label Primary Purpose: Treatment

Eligibility

Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No

Study Population:

Men with localized histologically confirmed T1B-T4 N0 and M0 prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed, previously untreated locally confined adenocarcinoma of the prostate
2. Patients older than 18 years old
3. Patients who accept to perform follow up in the radiation oncology department
4. Performance Status ≥ 70
5. Written informed consent

Exclusion Criteria:

1. Prior pelvic radiotherapy, radical prostatectomy, brachytherapy, cryotherapy or other local treatment
2. Presenting with positive pelvic lymph nodes or metastatic at the diagnosis (M1)
China Q Cohort Study

The burden of end-stage kidney disease (ESKD) is increasing worldwide. Although kidney transplantation is the most cost-effective renal replacement therapy, dialysis is still the main way to treat ESRD patients due to the limited kidney donor, with approximately 89% of such dialysis patients receive hemodialysis (HD) and the remainder receive peritoneal dialysis (PD). This distribution of dialysis modality, however, varies widely by health jurisdiction. For instance, more than 97% of dialysis patients are treated with HD in Japan, but more than 50% treated with PD in Mexico. Evidence comparing the two modalities suggests that mortality risks may be comparable, but all evidence come from observational study and there is no randomized controlled trial to compare patient survival between PD and HD due to patients enrollment issue.More importantly, for most health care systems, such as United States, United Kingdom, Australia, Indonesia and China, PD is less expensive than HD. It is possible, then, that a greater global utilization of PD might improve access to renal replacement therapy in less advanced economies.

The investigators have conducted a prospective, randomized, parallel, open-label, multi-center, non-inferiority trial to evaluate health-related quality of life (HRQoL) with PD versus conventional in-center HD in incident ESKD patients. A total of 1082 ESKD patients were randomly assigned to PD or conventional in-center HD, and 235 patients enrolled in stage 1 with complete measures of the "Burden of Kidney Disease" at both baseline and 48 weeks and 668 patients enrolled in stage 2 were included in analysis. However, this trial was designed to evaluate quality of life between PD and HD and all patients were follow-up 48 weeks. Therefore, in this observational cohort study, the investigators will perform extended follow-up for participants including in analysis . Our primary objective is to evaluate the association of dialysis modality (PD and HD) with all-cause mortality in ESKD patients. The investigators also explore the impact of PD and HD on major cardiovascular event composite (MACE), a composite outcome of MACE and all-cause death, hospitalized myocardial infarction, hospitalized stroke and hospitalized heart failure, healthy utility, dialysis cost, activity of daily living, and changes of RRF, hemoglobin, and other biochemical parameters.


Eligibility Criteria:
Inclusion Criteria:

* Adult (age ≥ 18 years old) peritoneal dialysis or in-center hemodialysis patient who have been recruited in previous China Q study and who enrolled in SURinD study with complete measures of the "Burden of Kidney Disease" at both baseline and 48 weeks.
* Will and able to provide the informed consent form (ICF).

Exclusion Criteria:

* Patients have stopped dialysis due to kidney function recovery or kidney transplantation.
* Patients refuse to provide consent.
Prevalence-based Health and Economic Model of the Bivalent Versus the Quadrivalent Human Papillomavirus (HPV) Vaccine

This study compares the health and economic impact of the bivalent HPV vaccine (HPV-1) and the quadrivalent HPV vaccine (HPV-2).

This study uses a prevalence-based model (by using efficacy data from each vaccine's respective trials and published cost data for Taiwan) which estimates the differences in lesions, genital warts, cervical cancer and costs from a healthcare payer's perspective prevented between HPV-1 and HPV-2 vaccines during one year (when all women are vaccinated). It also analyses costs from a societal perspective.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects vaccinated with either HPV-1 or HPV-2 vaccines in Taiwan (hypothetical group).

Exclusion Criteria:

* Not applicable.
Study to Evaluate Efficacy of Aflibercept in Neovascular Age-related Macular Degeneration Patients Non Responders to Anti-Vascular Endothelial Growth Factor

Patients with neovascular age-related macular degeneration who do not respond to usual treatment with conventional medications may respond to a new drug of the same class which is designed to block a larger fraction of proangiogenic factors.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* Men and women ≥ 50 years of age.
* Any choroidal neovascular membranes (CNVM) lesion (occult, minimally classic or classic) secondary to age-related macular degeneration
* Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity of: 20/32 to 20/320 (letter score of 73 to 25) in the study eye.
* Able to return for ALL clinic visits and complete all study-related procedures.
* Absence of other ocular diseases that could affect visual acuity.
* Patients without optimal response to ranibizumab or bevacizumab defined as:

  * Patient with significant persistent or recurrent fluid (intraretinal or subretinal) on OCT or any leakage on fluorescein angiography despite at least 4 injections within last 6 months, being the last OCT with presence of fluid within the 6 weeks after last treatment with ranibizumab or bevacizumab.
  * Patient with significant persistent or recurrent fluid (intraretinal or subretinal) on OCT or any leakage on fluorescein angiography despite three monthly treatment with ranibizumab or bevacizumab.

Exclusion Criteria:

* No scar, fibrosis, or atrophy involving the center of the fovea
* No retina pigment epithelium (RPE) rip/tear involving the central fovea
* Participation in another simultaneous interventional clinical trial
* Prior treatment with anti-VEGF or steroids therapy in the study eye within 28 days of baseline
* Prior treatment with photodynamic therapy (PDT)
* Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Baseline
* History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
* Active intraocular inflammation in the study eye
* History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment.
* Unable to undergo fluorescein angiography or fundus photography because of uncontrolled allergies
Effect of Orthokeratology on Myopia Progression in French Children

To evaluate and to compare the effect of orthokeratology (OK) on axial elongation in French myopic children.


Eligibility Criteria:
Inclusion Criteria:

* 7 to 17 years old
* Myopia between 0,50 D and 7.00 D
* Astigmatism ≤ 4.00 D with-the-rule 180+-20
* Anisometropia ≤ 1.50 D
* Myopia evolution ≥ 0.25 D over 6 months
* Best-corrected visual acuity (BCVA) ≥ 20/20 (Snellen equivalent)
* Follow-up period \> 6 months

Exclusion Criteria:

* Prior history of any other myopia control treatment (except for single vision distance spectacles)
* Contraindication for contact lens wear or orthokeratology
* Preexisting ocular (amblyopia, strabismus, ocular inflammation, trauma, or surgery) or systemic disease
* Poor compliance to lens wear, examination or follow-up
An Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients With Generalized Myasthenia Gravis

The purpose of this study is to evaluate the long-term safety and tolerability of M281 in participants with generalized myasthenia gravis (gMG)


Eligibility Criteria:
Participants must be ≥18 years of age with a documented history of Generalized Myasthenia Gravis (gMG) and clinical signs/symptoms of gMG, not pregnant or breastfeeding, previously participated in the MOM-281-004 study, had no major eligibility deviations or other major protocol deviations or not met any of the stopping criteria or discontinued study drug in the MOM-M281-004 study for any reason other than the need for rescue therapy as specified in the MOM-M281-004 study.

Additional, more specific criteria are defined in the protocol.
Polarized Reflectance Spectroscopy for Oral Lesions

In this study the investigators are conducting research to determine whether a new optical device using polarization reflectance spectroscopy can help doctors or dentists identify abnormalities in the mouth that require follow-up. To establish this, measurements are needed from a large number of individuals with different abnormalities in their mouth.

The investigators believe the proposed approach has potential to improve and enable mass screening for precancerous and early cancers of the oral cavity by improving the predictive value of oral cavity exams, particularly for less experienced practitioners.

The information from this study will be compared to results from the pathology report of the tissue taken from your mouth.

Hypothesis:

1. Polarized reflectance spectroscopy can distinguish high-risk oral lesion from normal and reactive oral lesions.
2. Polarized reflectance spectroscopy can capture low-grade oral lesions that have characteristics associated with a high risk of progression to cancer.

The clinician will place a fiber-optic probe designed to measure the polarized reflectance spectra over the visible optical region on a site of interest in the subject's mouth, including lesional mucosa, normal adjacent and contralateral mucosa. The site for placement of the probe will be determined by the examiner, an experienced Oral Pathologist. The probe examination will take no more than 15 minutes in addition to the subject's appointment time for their routine visits.

A 4um unstained tissue section from surgery or biopsy, part of their scheduled care, will be requested for quantitative histological analysis. The morphometric parameters obtained from polarized reflectance measurements will be compared with the histology and quantitative pathology (nuclear phenotype score) from the tissue sections from the lesion. The collected spectra data from normal looking areas from adjacent normal looking mucosa and contralateral mucosa will be used to determine patient to patient variation in the polarized reflectance of oral mucosa.

Eligibility Criteria:
Inclusion Criteria:

* You attend the Dental Department at the British Columbia Cancer Agency
* You have an abnormal lesion in the mouth
* You fully understand the study and give your informed consent to participate as demonstrated by signing this consent form

Exclusion Criteria:

* You are under the age of 18 years.
Camrelizumab in Combination With Neoadjuvant Chemotherapy for Resectable Thoracic Esophageal Squamous Cell Carcinoma

This study aims to evaluate the efficacy of Camrelizumab with neoadjuvant chemotherapy for resectable thoracic esophageal squamous cell carcinoma


Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of thoracic Esophageal squamous cell carcinoma
* ECOG performance status 0-1
* Age 18-75 years
* Resectable disease, cT2-4aNanyM0 or cT1-3N+M0
* Life expectancy more than 6 months
* Use of an effective contraceptive for adults to prevent pregnancy

Exclusion Criteria:

* Not suitable for surgery
* Prior chemotherapy, radiotherapy and immune-oncology therapies for ESCC
* Prior esophageal, gastric, or gastro-esophageal junction surgery
* Esophageal ulcer, esophageal perforation，chest pain（≥middle level）
* Pregnant or lactating women