cyrilzakka/clinical-trials huggingface dataset:
Use of Plasma Rich in Growth Factors (PRGF) in Pilonidal Sinus Excision

The use of plasma rich in growth factors in wound excision pilonidal sinus could improve the healing process of the wound, when compared with the usual technique of daily local healing. The investigators propose the objective of evaluating the efficacy of intra- and postoperative application of plasma rich in growth factors, to reduce healing time and complications, arising from its removal, compared to the standard surgical treatment.

prospective randomized control trial, comparing PRGF application vs daily local care(betadine +saline) in sinus pilonidal wound excision. PRGF is extracted from de patient blood and infiltrated in the pilonidal wound every week. this treatment is compared with betadine and saline wound care in terms of wound healing time, pospoperative pain and other complications.

this study try to keeps the advantages of using open technique for pilonidal desease( low recurrence rate and surgical site infections) and improving the disadvantages (high wound healing time and postperative pain with wore quality of life) when it´s compared with direct closure or flap techniques.

Eligibility Criteria:
Inclusion Criteria:

* Patients among 13 and 65 years old
* Possibility of observation during the follow-up period
* Patients who have read and signed informed consent

Exclusion Criteria:

* Abscessed pilonidal sinus
* Recurrent pilonidal sinus
* Patients treated with immunosuppressive drugs or anticoagulants
Intraprostatic PRX302 Injection to Treat Localised Prostate Cancer

The purpose of this study is to determine a safe, effective, and tolerable dose of PRX302 for the treatment of low to intermediate risk prostate cancer.

A multi-centre, open label, phase IIb study, evaluating the safety, tolerability and efficacy of a targeted intraprostatic focal administration in development. The study will treat approximately 40 men who meet the eligibility criteria, and give written consent. Safety and tolerability will be assessed post-treatment over 26 weeks. Efficacy will be assessed by biopsy and imaging (mpMRI) at 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Life expectancy ≥ 10 years.
* Serum prostate-specific antigen (PSA) ≤ 15ng/mL.
* A histologically proven, clinically significant lesion visible on mpMRI (magnetic resonance imaging) that is accessible to PRX302 transperineal injection.
* Radiological stage T1-T2 N0 Mx/M0 disease.
* Targeted prostate biopsy within 6 months prior to dosing, with a clinically significant lesion correlating with an mpMRI visible lesion.

Exclusion Criteria:

* Previous radiation therapy to the pelvis.
* Androgen suppression or anti-androgen therapy within the 12 months prior to dosing, for prostate cancer.
* Use of 5-alpha reductase inhibitor within the 3 months prior to dosing.
* Evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging.
* Inability to tolerate transrectal ultrasound (TRUS).
* Known allergy to latex or gadolinium (Gd).
* Prior rectal surgery preventing insertion of the TRUS probe.
* Any previous ablative procedures performed on the prostate, e.g., electroporation, radiofrequency ablation, high-intensity focused ultrasound (HIFU), cryosurgery, photochemical, thermal or microwave therapy to treat cancer of the prostate.
* Unable to have pelvic MRI scanning (severe claustrophobia, permanent cardiac pacemaker, metallic implant, etc., likely to contribute significant artifact to images).
Effect of CFR and Iron Supplementation on Iron Status and Gut Microbiota of 1-2 Years Old Myanmar Children

Complementary feeding diet in developing countries cannot meet iron requirements of infants and young children. Iron supplementation is mostly used to treat iron deficiency whereas iron fortification is cost-effective strategy to control iron deficiency in developing countries. However, a recent study showed that iron fortification imposed negative impact on gut microbiota by increasing colonization of gut pathogen over beneficial bacteria. Gut microbiota plays essential roles in nutrient absorption, vitamin synthesis; intestinal mucosal barrier function and pathogen displacement. Iron is essential for growth and virulence of most gut pathogens and so iron supplementation might have similar negative impact on gut microbiota composition. Therefore, nutrition interventions would not be justified by assessing micronutrient status alone ignoring any possible deterioration of gut microbiota. The investigators hypothesized that optimizing the nutrient intake from locally available foods according to complementary feeding recommendation (CFR) can improve the iron status of these children while maintaining healthy gut microbiota composition.

A randomized, placebo-controlled, community-based, intervention trial will be conducted in Ayeyarwady division of Myanmar where childhood undernutrition is prevalent. The aim of this study is to compare the effect of optimized CFR to iron supplementation on iron status and gut microbiota composition of 1-2years old Myanmar children. Cluster randomization will be done at the village level to randomly allocate the villages into CFR or non-CFR villages. Individual randomization will be done to randomly assign each child into iron or placebo syrup so that individual children will receive one of 4 treatment groups (CFR, Fe, CFR + Fe, and Control) for a period of 24 weeks. Based on expected between-groups difference of hemoglobin 5g/L, at 80% power, 5% level of significance, 15% drop-out rate; after taking into account the cluster effect; required sample will be 109 per group (total = 436). A sub-sample of 15 children from each group will be randomly selected for gut microbiota assessment (total = 60). Blood samples for iron status and stool samples for gut microbiota assessment will be collected at baseline and endline. Anthropometric measurements, usual intake of iron and infectious disease morbidity will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Age between 12-18 months
* Apparently healthy
* Not consuming regular iron containing supplements during the last 4 months

Exclusion Criteria:

* With severe anemia (Hemoglobin \< 50g/L)
* Malaria test positive with Immuno-chromatographic test (ICT)
* Mothers/ Caregivers are not willing to join the study
* Suffer from chronic diseases which can affect their dietary intake
Impact of Social Media on the Development of Anorexia Nervosa

The study involves the recruitment of medical students from all government medical colleges of Karachi,Pakistan. The sample size was 214. The study is a cross sectional study that requires the participants to fill out an online questionnaire after giving an informed consent online.

The study involves the recruitment of medical students from all government medical colleges of Karachi, Pakistan. The sample size was 214. The study is a cross sectional study that requires the participants to fill out an online questionnaire after giving an informed consent online.The questionnaire contained 15 items related to their social media use and its impact on their body image and eating behaviours.

Eligibility Criteria:
Inclusion Criteria:

* Medical students of Karachi
* All should be aged 18 to 25 years
* Both genders included

Exclusion Criteria:

* Non consenting participants
* Those who donot have access to social media
Frequency of Circulating Tumour Cells in Stage II and Stage III Colon Cancer Patients

This study will determine whether a new diagnostic test called the Cell Search Assay can detect circulating colon cancer cells in patients who have had surgery for colon cancer and had visible cancer removed. Other parts of the study will look at whether the presence of the circulating tumor cells in blood predicts whether a patient will have their colon cancer return.


Eligibility Criteria:
Inclusion Criteria:

* stage II or III colon cancer

Exclusion Criteria:

* none
Post-exercise Therapeutic Modalities on Functional Performance, Muscle Damage and Oxidative Stress of CrossFit® Athletes

Crossfit® is a training modality that consists in functional movements, constantly varied and executed at high intensity. Both training sessions and competitions involve physically demanding activities, which in addition to being performed at very high intensity also involves the aerobic metabolism pathway. These characteristics led to very high metabolic and muscular stress, as well as decrease in physical performance immediately after competitions and training sessions. The cumulative effects of the metabolic and muscular stress can be a precursor of injuries. Studies using different therapeutic modalities aiming to improve post-exercise recovery are needed in order to tackle this issue.

Oxidative stress induced by exercise has been a research field in constant growth, due to its relationship with the processes of fatigue, decreased production of muscle strength, and its ability to cause damage to the cell.

To the date there are no studies comparing the effects of different therapeutic modalities applied after an exercise session on functional performance, muscle damage, and oxidative stress in an exercise modality such as Crossfit®.

Therefore, the aim of this project is to assess and compare the effects of different therapeutic modalities on functional performance, muscle damage, and oxidative stress of Crossfit® athletes.

A randomized, crossover, controlled trial will be carried out.

All volunteers will be allocated to four interventions, and the order of the interventions will be randomized.

The outcomes will be assessed at baseline (prior to the Workout of the Day - WOD), and in different timepoints after the WOD.

The WOD will be consisted in finishing as quickly as possible a sequence of three exercises (Calories in Assault AirBike®, Hang Squat Clean and Box Jump Over), in a well-known series model for the athletes, without rest.

The investigators will analyze functional performance, biochemical markers of muscle damage and oxidative stress, the ratings of perceived exertion, and the volunteers satisfaction with the interventions.

All data will be analyzed both in their absolute values and in relation to their percentage variation from the values obtained in the pre-WOD (baseline) assessments.

Eligibility Criteria:
Inclusion Criteria: - Crossfit® amateur male athletes; - Do not present a history of musculoskeletal injury in the regions of the hips, knees and calves in the month preceding the study; - Are not using pharmacological agents; - Athletes should have been practicing the sport for at least 1 year; - Voluntarily commit to participate in all stages of the study.

Exclusion Criteria: - Present musculoskeletal or joint injuries during data collection; - Present history of musculoskeletal injury in the regions of the hips, knees and calves in the month preceding the study.
A Study to Assess Programmed Death Ligand-1 (PD-L1) Expression in Cytological Versus Histological Lung Cancer Specimens

The primary purpose of this non-interventional, multinational study is to assess the feasibility of assessing PD-L1 protein expression on cytological samples as a surrogate for histological samples obtained from participants with any stage of non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC).


Eligibility Criteria:
Inclusion Criteria:

* Samples must have been collected in a manner that is compliant with local ethics committee guidance
* Samples must originate from participants diagnosed with NSCLC or SCLC
* Participants must have a pair of at least one cytological and one histological specimen that: Both originate from inside the thorax or from the same ex-thoracic site; Are confirmed to have been collected within a window no more than 6 weeks apart from each other; and are in compliance with the protocol defined sample requirements for histological and cytological specimens

Exclusion Criteria:

* Immune checkpoint inhibitor therapy from 4 weeks prior to collection of the first tumor sample until collection of the second matched sample
Comprehensive Risk Assessment and Prevention Plan of Osteoporosis and Sarcopenia for the Elderly Participating in Community-based Long-term Care Services

The purpose of this project is:

1. Provide the epidemiological data of the prevalence, incidence, and risk factors of osteoporosis and sarcopenia among the elderly in rural areas.
2. Screen osteoporosis and sarcopenia among the elderly and provide with assistance for following care in order to improve the diagnosis and treatment rates of osteoporosis and sarcopenia
3. Construct a pragmatic and integrated care service model for osteoporosis and sarcopenia in the elderly people from rural areas

Detailed Description:

Investigators plan to use a stepped-wedge cluster randomized trial that allocates participants into the following three groups:

1. Screening group: Inform the elderly about the results of the screening and recommend those with moderate to high risk of fracture to receive active examination and treatment.
2. Multi-disciplinary team intervention group: Introduce integrated services of health education, nutrition, rehabilitation, medication evaluation and other multi-specialties to assist study participants with health promotion.
3. Control group (Delayed intervention): receive general care after collecting basic information, and provide health education related information such as osteoporosis sarcopenia. After two year's follow-up, multi-disciplinary team intervention service will be implemented.

Eligibility Criteria:
Inclusion Criteria:

* Age≥ 50 old and lived in the community

Exclusion Criteria:

* Life expectancy less than two years
The Association Between Molecular Typing of Treponema Pallidum and Treatment Efficacy and Clinical Findings

The investigators compare the treatment results and clicical presentations of different Molecular subtyping of Treponema pallidum


Eligibility Criteria:
Inclusion Criteria

1. Persons with confirmed early symptomatic syphilis (primary or secondary) or high-titer latent syphilis

Exclusion Criteria:

1. Pregnant woman
2. Known allergy to penicillin
3. RPR titers were found to be 1:8 or less
The Effects of an Exercise Regimen Following TMJ Arthrocentesis

The goal of this study is to evaluate the short- and long-term effects of a self-administered exercise program on pain levels, jaw movement range, and jaw function in patients with temporomandibular joint (TMJ) disorders. The main question it aims to answer is:

Does adding a self-administered exercise program to arthrocentesis improve pain, mouth opening, and jaw function compared to arthrocentesis alone in patients with TMJ disorders?

Participants with acute or chronic TMJ pain lasting at least three months and limited mouth opening will undergo arthrocentesis, with one group also following an exercise regimen. Outcomes will be assessed over a 6-month follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Limited mouth opening (\<35mm) and joint pain complaints according to the DC/TMD examination form,
* Pain complaints for 3 months or longer,
* Able to understand Turkish in spoken and written language,
* Patients who can read the written consent form and give signed consent will be included in the study.

Exclusion Criteria:

* Those with serious neurological disorders,
* Those with autoimmune disorders involving muscles or joints,
* Those with a history of alcoholism,
* Patients diagnosed with malignancy,
* Patients who have previously undergone surgery or radiotherapy in the head and neck region,
* Those with other TMD diagnoses that do not cause restriction or pain in mouth opening,
* Those who have received other treatments for the neck or TMJ regions in the last 3 months,
* Those with a history of surgical treatment for the temporomandibular joint,
* Those with a history of allergy to any of the agents used in the treatment process,
* Those who use drugs that affect the musculoskeletal system, and
* Pregnant patients will not be included in the study.
Injured Spinal Cord Pressure Evaluation Study - Transverse Myelitis

ISCoPE-TM will use intra spinal monitoring techniques to assess cord perfusion and metabolism in patients with severe spinal cord damage from transverse myelitis

Transverse myelitis (TM) is a rare inflammatory condition of the spinal cord. It is characterised by rapid onset of motor, sensory or autonomic dysfunction causing neurological deficit. It has a diverse range of causes; most commonly it is associated with multiple sclerosis and neuromyelitis optica also known as Devic's disease or Devic's syndrome, is a heterogeneous condition consisting of the simultaneous inflammation and demyelination of the optic nerve (optic neuritis) and the spinal cord (myelitis). It affects approximately 1900 adults and children in the UK annually, with 350 cases per year of unknown cause.

Outcome in TM is variable; e.g. neuromyelitis optica mortality can be 30% . There is a relationship between the severity of neurological symptoms at presentation and the eventual outcome. When a patient is ASIA (American spinal injuries association) A or tetraplegic at presentation, they are less likely to recover than when ASIA B/C or paraplegic. Approximately 30% of patients will be ASIA A-C after a TM episode.

There are several pathological mechanisms which could increase the risk of decreased blood supply and further neurological deficit in TM. The ISCoPE study has shown that in traumatic spinal cord injury when swelling causes mechanical compression of the cord against the dura there is increased intra spinal pressure (ISP).

The Investigators propose to monitor the ISP and spinal cord metabolites in 10 TM patients with MRI evidence of a swollen enlarged spinal cord. There has never been a study looking at ISP in TM patients before. The optimum blood pressure in patients with TM is not known.

The investigators aim to observe a previously unrecognised pathological mechanism of injury in TM. In the future this could lead on to novel treatments to improve drug delivery and neurological outcome in a condition otherwise associated with a poor outcome.

Eligibility Criteria:
Inclusion Criteria:

* Transverse myelitis (as defined by TM working group 2002)
* MRI evidence of swollen enlarged spinal cord. Defined as a larger cord diameter compared to the adjacent normal signal intensity spinal cord, with loss of cerebrospinal fluid space between cord and dura mater.
* Age 18 - 70
* Severe spinal cord injury (ASIA A - B)
* Monitoring to start within 72 h of MRI
* Capacity for informed consent

Exclusion Criteria:

* Major co-morbidities likely to influence outcome
* High anaesthetic risk precluding surgery
* Multiple separate lesions on MRI spine
* Lacking capacity or Unable to consent
* Pregnancy
Does Intraoperative Methadone Prevent Postoperative Pain in Bariatric Surgery?

The recent increase in obesity has led to an increase in the need for bariatric surgery. In this group of patients the postoperative pain management is of vital importance. One strategy to improve postoperative analgesia is the use of intraoperative methadone, specially in those patients which regional anesthesia is not feasible. There is evidence that the use of intraoperative methadone can lead to a analgesia lasting 24 to 36 hours, while not associated with increased side effects when compared to other opioids with short or intermediate duration of action. In this study the investigators will evaluate the efficacy of intraoperative methadone in reducing postoperative pain and opioid consumption.

Despite recent developments in postoperative pain control, many patients still suffer from moderate to severe pain after surgery. It is estimated that postoperative severe pain occurs in 20 to 40% of surgical procedures. With the recent increase in obesity incidence in the last years, the need for bariatric surgical intervention is greater. The management of postoperative pain in obese patients is particularly important, since this population have increased susceptibility to cardiovascular, pulmonary and thromboembolic perioperatively.

One of the strategies to improve pain management in the perioperative period is the intraoperative use of intravenous methadone, given its pharmacokinetic profile, specially in those patients in which regional anesthesia is contraindicated. Methadone is an opioid μ (MOR) receptor agonist, also a glutamate antagonist by blocking the N-methyl-D-aspartate (NMDA) receptor and a reuptake of serotonin and noradrenaline inhibitor. Intraoperative analgesia generated by administration of 20 to 30 mg methadone can last 24 to 36 hours. There is also evidence that methadone at 0.2 to 0.3 mg / kg is not associated with an increased incidence of side effects compared to other opioids with short or intermediate duration of action, such as fentanyl, sufentanyl and morphine.

The aim of this study is to evaluate the efficacy of intraoperative methadone in reducing postoperative pain and opioid consumption in patients undergoing open gastroplasty with or without associated Roux Y. Patients will undergo standardized general anesthesia, and the opioid used in anesthesia induction is methadone 0.15 mg / kg fentanyl or 6 mcg / kg bolus with additional if necessary. After extubation a intravenous morphine patient controlled analgesia device will be already available in the operating room. Groups will be compared regarding opioid consumption, pain scores, side effects, patient satisfaction and development of chronic postoperative pain.

Eligibility Criteria:
Inclusion Criteria:

* Open bariatric surgery
* No contraindications for any drugs used during the trial
* Read, understood and signed the informed consent

Exclusion Criteria:

* Laparoscopic bariatric surgery
* Known allergy to any drugs used during the trial
* Cardiovascular disease
* Creatinine clearance lower than 60 mL/min/1.73 m2
* Chronic usage of opioids
* History of personality disorder
Diagnosis of Cardio-Pulmonary Pathology Using Transthoracic Parametric Doppler (TPD)

This is a study that seeks to characterize data obtained from patients with a variety of lung diseases using ultrasound signals obtained from the lung tissue. A standard ultrasound instrument in the doppler mode (not the imaging mode used in examination of pregnant women for instance) is placed on the chest wall and the unique software the investigators have developed analyzes the signal reflected back from within the lung. On the basis of pilot studies performed previously the investigators expect to receive different signals from different diseases. The investigators seek to further characterize these signals to enable accurate diagnosis of different lung diseases using our technology.


Eligibility Criteria:
INCLUSION CRITERIA

Age 18 years or older Patients who are clinically suspected of having pulmonary, cardiac or Cardio-pulmonary disease preferably any one or more of the conditions listed below:

* Patients with CHF
* Patients with pulmonary hypertension with documented right heart catheterization data
* Patients with COPD in two subgroups:

  * Emphysema, (evidence of emphysema on High Resolution Computed Tomography, (HRCT) and airflow limitation of GOLD II severity who have had Carbon Monoxide Diffusing capacity, (DLCO) and Residual Volume(RV) measured, or patients without HRCT with measurements of lung volumes and diffusing capacity with Total Lung Capacity (TLC) ≥1.0 predicted, RV/TLC ≥0.4, DLCO ≤ 0.7 predicted.
  * Chronic Bronchitis (No evidence of Emphysema on HRCT and/or no evidence of air-trapping or reduced DLCO.)
* Patients with asthma according to ATS/ERS definition,
* Patients with interstitial lung disease (ILD) of any etiology including sarcoidosis diagnosed by HRCT in sub groups as follows:

  * Mild ILD (TLC 0.71-0.79 predicted, DLCO ≥ 0.71 predicted)
  * Moderate and severe ILD (TLC ≤ 0.7 predicted, DLCO ≤ 0.7 predicted)
* Signed informed consent.
* Patients with sarcoidosis without evidence of parenchymal lung disease defined as normal DLCO and/or HRCT.

EXCLUSION CRITERIA

* Patients unable to cooperate.
* Inability to assume a semi-reclining or supine position
* Patients with severe chest wall deformity