cyrilzakka/clinical-trials huggingface dataset:
Impact of Photobiomodulation (PBM) on Biomarkers of Radiation Lymphedema and Fibrosis in Head and Neck Cancer Patients

Radiation fibrosis syndrome (RFS) is a general side effect of radiation therapy (RT) which can adversely impact patients chronically over years typically triggered by an acute inflammatory state that evolves into chronic inflammation and tissue remodeling causing lymphedema, fibrosis, pain, atrophy and organ dysfunction. Some of the side effects that encompass RFS in the head and neck (HNC) population include decreased ability to fully open the mouth (trismus), neck pain and tightness (cervical dystonia), lymphedema (swelling), difficult with speech and swallowing and salivary hypofunction. Although there is Level I evidence demonstrating the benefit of Photobiomodulation (PBM) therapy to prevent acute mucositis in HNC patients treated with RT, there is only limited data regarding its impact.

This is a clinical trial to compare active treatment (PBM-therapy) with sham control (Sham- therapy). Up to 60 patients will be randomized to the two groups with equal allocation to estimate the efficacy (soft tissue thickness) of external Photobiomodulation (PBM) with light-emitting diode (LED) planned therapy for the treatment of radiation fibrosis syndrome (RFS) in head and neck cancer (HNC) patients who have undergone radiation therapy (RT) compared with sham control.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated with radiation for head and neck cancer who are ≥ 3 months \< 36 months post-RT (last RT).
* Patients who received at least 50Gy of bilateral neck RT. Subjects who received RT or concurrent chemoradiation (chemoRT) therapy for HNC are eligible.
* No evidence of disease as documented by imaging 3 months after completion of RT.
* Common Terminology Criteria for Adverse Events (CTCAE) fibrosis score ≥ 2 at enrollment.
* Patient who has body mass index (BMI) \>30 at the time of enrollment may be excluded at a discretion of the principal investigator if fibrotic areas cannot be identified by clinical objective assessment of fibrosis.
* Willing to comply with all study procedures and be available for the duration of the study.

Exclusion Criteria:

* Woman who are pregnant or planning to become pregnant or breast-feeding.
* Patients enrolled on another drug or device investigational trial for prevention or treatment of LEF.
* Patients deprived of freedom, under supervision or guardianship.
* Patients unable to attend to scheduled visits due to geographical, social or mental reasons.
* Patients who received prior PBM therapy for RT toxicities in the last year;
* Patients who report being photosensitive.
* Patients who have chronic immunosuppression or are on current immunosuppressive therapies.
* Any patient who, in the opinion of the investigator, is unable or unlikely to comply fully with the study requirements or procedures for any reason.
International GNE Myopathy Patient Registry

GNE myopathy, an ultra-rare disease, is a severe progressive myopathy that typically presents in early adulthood as weakness in the distal muscles of the lower extremities and progresses proximally, leading to a loss of muscle strength and function, and ultimately a wheelchair-bound state. The rate of progression is gradual and variable over the course of 10-20 years or longer.

There is a need to understand the world wide epidemiology of this ultra-rare condition, better understand a long-term disease course and the progression of disease-specific features, support translational research by evaluating burden illness and support clinical research recruitment. Therefore, the study will longitudinally collect information via an online patient registry platform.

GNE myopathy is an ultra- rare condition. Most of the knowledge is coming from case reports or small cohort observations. There is a need to more precisely understand the long-term disease course and the progression of disease-specific features of GNE myopathy, and in turn characterise the overall burden of this illness. Also, to better understand the disease, describe it variability, genotype-phenotype correlation, quality of life, epidemiology, health-economics aspects and need for assistive walking devices. Collected data needs to be harmonised to be compatible collaborative work with Remudy (Japanese patient registry). This collaborative effort will enable the analysis of the largest GNE myopathy data set in the world. To this end, this study will collect patient information longitudinally. Upon patient's agreement, the registry curator can contact nominated clinicians to request additional data or data validation.

Study Objectives

The objectives of the study are to:

* Longitudinally characterize disease-specific features of GNE myopathy
* Characterize the burden of illness and quality of life in patients with GNE myopathy
* Support recruitment in research activities
* Inform registry participants via newsletters about scientific developments in the GNE myopathy field

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older at the time of informed consent
* Clinical and/or genetic diagnosis of GNE myopathy (also known as HIBM, QSM, Inclusion Body Myopathy Type 2, DMRV, or Nonaka disease)
* Willing and able to provided electronic (or written) consent and comply with all study requirements.

Exclusion Criteria:

* Under 18 years of age
Holmium Versus Bipolar en Bloc Transurethral Resection of Urothelium Tumor of the Urinary Bladder

En bloc resection of bladder tumors (ERBT) may improve staging quality and perioperative morbidity and influence tumour recurrence

Modern laser technology has led to new alternatives to conventional TURBT (cTURBT). The advocates of ERBT have three goals: to improve resection quality, lower perioperative complication rates, and decrease recurrence rates at resection sites. The present study is the first to compare the results of laser and electric en bloc resection of bladder cancer with respect to the aforementioned goals.

the investigators aim to compare the clinical outcome in the form of safety and efficacy between Holmium and bipolar transurethral en bloc resection of urinary bladder tumors.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients of both sexes presented with urinary bladder tumor aiming for complete resection as diagnosed by Ultrasound with or without CT prior histopathological assessment.

Exclusion Criteria:

* Patients with signs of extravesical tumor extension where complete resection will not beneficial or unable to proceed to complete resection due to huge tumor burden either huge single tumor more than 5 cm or multiple tumors that are not candidate for complete resection.
Parkinson's Disease Registry of the Muhammad Ali Parkinson Center

The purpose of the Parkinson's disease Registry is to develop a national and international database of persons with Parkinson's disease (PD). The Registry will be used to facilitate the development of new therapies and healthcare services to improve the quality of life for people with PD. It will also be a means for investigators in the field of PD to quickly identify and notify subjects about other research studies for which they are eligible.

Objectives include:

* Assess current treatment approaches and develop best-practice guidelines
* Track the functional abilities, access to healthcare and cost of illness of people with PD over time
* Drive the development of innovative research projects
* Accelerate the process of informing patients of research projects for which they may be eligible

What do you need to know?

* Any individual diagnosed with PD is eligible to enroll.
* Participation in the registry is voluntary, confidential and free of charge.
* Eligible participants will be notified about opportunities to participate in clinical trials, though they are under no obligation to enter.
* Participants will need to complete an updated questionnaire every six months.
* Participants may also be asked to complete additional surveys for PD research projects.
* Any data provided will be used in scientific publications in summary form only.
* Participant names will not be released to anyone outside the Parkinson's disease Registry management team without written authorization, nor will names be sold for advertising or fund-raising purposes.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Parkinson's disease

Exclusion Criteria:

* No clinical diagnosis of Parkinson's disease
Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis

The purpose of this study is to assess the efficacy of etrasimod on clinical remission in participants with moderately to severely active ulcerative colitis (UC).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with ulcerative colitis (UC) ≥ 3 months prior to screening
* Active UC confirmed by endoscopy

Exclusion Criteria:

* Severe extensive colitis
* Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD
* Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
The Effect of Bovine Colostrum Supplementation in Older Adults

Bovine colostrum is the initial milk secreted by cows during the first day after calving. Colostrum is high in protein and contains a number of substances that have potential to be beneficial for the immune system. Preliminary studies about effects of colostrum supplementation show its potential for increasing human exercise performance; however, more evidence across the lifespan is required to confirm effects and to understand mechanisms of action. The objectives are to determine the effect of 8 weeks of bovine colostrum supplementation, compared to whey protein supplementation on the following dependent variables in men and women 50 years and older while participating in a resistance-training program:

* muscle mass
* strength
* blood levels of growth factors and markers of inflammation
* urine levels of muscle and bone catabolic markers
* tests of cognitive ability It is hypothesized that bovine colostrum supplementation will result in greater increases in muscle mass, strength, blood IGF-1 levels (an anabolic hormone), and cognitive ability, and greater reductions in inflammation, and markers of muscle and bone catabolism, compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Men or women 50 y or older

Exclusion Criteria:

* Milk allergies
* Contraindications to exercise as indicated by the Physical Activity Readiness Questionnaire
Collection of Circulating Biomarkers in Pancreatic Cancer

This protocol will involve collection of blood samples from patients with a diagnosis of pancreatic adenocarcinoma for evaluation of circulating biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* The subject must have a known or presumed diagnosis of pancreatic adenocarcinoma
* The subject must be a patient of the University of Pennsylvania
* The subject must be able to provide informed consent
* The subject must be 18 years of age or older

Exclusion Criteria:

. Subjects who have any clinically significant psychiatric, social, or medical condition that, in the opinion of the investigator, could increase the patient's risk, interfere with protocol adherence, or affect the patient's ability to give informed consent are ineligible to participate in the study.
Randomized Controlled Trial of Vaginal Cryotherapy for Pelvic Floor Myofascial Pain

This is a placebo-controlled, randomized controlled trial to investigate the role of vaginal cryotherapy on pelvic floor myofascial pain in women. This study involves randomizing patients who are found to have pelvic floor myofascial pain on examination into one of two treatment groups: transvaginal cryotherapy or transvaginal application of a room-temperature tube. Patients will be followed up at two different time points in order to assess response to treatment. Follow-up times include immediately after application (Specific Aim #1) and two weeks following use of the intervention alone (Specific Aim #2). Patients will receive verbal and written instructions on using the intravaginal tubes by the research assistant who will not be blinded to treatment allocation. Patients will not be blinded to their treatment assignment but will not be given information on the alternative treatment. Patients will be referred to pelvic floor PT, which is considered the standard of care for treatment of pelvic floor myofascial pain at this time. As it typically takes 2-3 weeks to get in to see one of the pelvic floor PT providers at Wash U, follow up for this study will be completed prior to their attendance at pelvic floor PT. Patients will complete validated questionnaires assessing their pain, other pelvic floor symptoms, and acceptance of the intervention as a treatment option at the follow up time points.


Eligibility Criteria:
Inclusion Criteria:

* Adult (\>18yo)
* Women
* Patients found to have pelvic floor myofascial pain of at least 4/10 in severity at any of the four sites (right obturator internus, right levator ani, left levator ani, left obturator internus)

Exclusion Criteria:

* Age \<18
* Non-English speaking
* Current diagnosis of dementia
* Limited physical mobility that would prevent full participation in pelvic floor PT.
* Prior use of vaginal cryotherapy
* Chief complaint or known history of pelvic pain
Diuretics In the Management of Essential Hypertension (DIME) Study

The purpose of DIME is to evaluate the safety (i.e. new onset of diabetes and other metabolic adverse events), efficacy and cost-effectiveness of antihypertensive treatment with low dose diuretics. The researchers' hypothesis is that use of low dose thiazide diuretics is metabolically safe when used with other appropriate antihypertensives, effective in reduction of blood pressure and cheaper than treatment without diuretics. Therefore, this study is an equivalence trial.

There has been substantial evidence from clinical trials to support the rationale of use of thiazide diuretics in patients with essential hypertension. Diuretics may be more effective in reduction of blood pressure in Japanese patients than Caucasian because of higher salt intake. Moreover, given a large number of hypertensive population here, diuretics may be the most cost-effective antihypertensive agent. Japanese physicians, however, tend to avoid diuretics even in elderly hypertensive patients because of much concern over metabolic adverse events including new onset diabetes, which is deemed to increase cardiovascular risk. Although it is unlikely that use of low dose (12.5 mg of HCTZ or less) diuretics is associated with metabolic adverse events when they are given with any other appropriate antihypertensive agents (e.g. Ca antagonist, ACE inhibitor, ARB, K sparing diuretics) other than β-blockers, the researchers have to confirm the safety of low dose diuretics in terms of new onset diabetes in Japanese, who are assumed to be "diabetes prone" based upon thrifty gene hypothesis.

Eligibility Criteria:
Inclusion Criteria:

* Aged 30 to 79 years
* With blood pressure being \>150/\>90 if they are not on any antihypertensive treatment
* With blood pressure being \>140/\>90 if they are already on antihypertensive drugs
* No history of type 2 diabetes
* No history of gout

Exclusion Criteria:

* With supine blood pressure being \>200/\>120
* Patients already on antihypertensive treatment if duration of treatment and drugs used are not identified
* Patients already on thiazide diuretics
* With type 2 diabetes
* With gout or hyperuricaemia (\>8.0 mg/dl)
* With hypokalemia（\<3.5mmol/L）
* With erectile dysfunction
* With renal dysfunction (s-creatinine \> 2.0 mg/dL)
* With history of serious adverse reaction to thiazide diuretics
* With history of stroke or myocardial infarction within 6 months
* With history of percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) within 6 months or in whom these interventions are planned
* With heart failure or left ventricular dysfunction (ejection fraction\<40%)
* Patients who should be on thiazide diuretics
* With history of malignant tumor within 5 years
* Pregnant, possibility of pregnancy, or during breast feeding
* Patients who are deemed not eligible for this study for any reason
A Study Based on the French National Health Insurance Database in Participants With Psychotic Disorders

The primary purpose of the study is to compare therapy with antipsychotic medication (antipsychotic monotherapy or antipsychotic combination) versus no antipsychotic medication, and antipsychotic monotherapy versus antipsychotic combination, regarding time to psychiatric rehospitalization, in participants with a psychotic disorder (that is, schizophrenia, schizotypal disorders, schizoaffective disorders, persistent or acute or induced or non-organic delusional disorders, recurrent depressive disorder with psychotic symptoms).


Eligibility Criteria:
Inclusion Criteria:

* At least one discharge for psychiatric hospitalization with a diagnosis of a psychotic disorder between January 1, 2014 and December 31, 2020.
* At least one long-term disease record (LTD), (which is a French administrative status allowing the full reimbursement of the cost of a chronic pathology) with a diagnosis of a psychotic disorder between January 1, 2014 and December 31, 2020.
* Age of 18 years or older at index date (first date found in the previous conditions).

Exclusion Criteria:

• Due to data management constraint, the participants with multiple or temporary identifiers in the database (indistinguishable in database) will be excluded. This happens with twins or migrants, for example.
Study of Adjuvant Topotecan and Cisplatin With Concurrent Radiation Therapy for Advanced Cervical Cancer

A Phase I Study of Adjuvant Topotecan and Cisplatin with Concurrent Radiation Therapy for Advanced Cervical Cancer.

Examines the effects of Topotecan and Cisplatin with radiation for advanced cervical cancer

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed advanced cervical carcinoma who, following optional surgical staging, are not deemed to be curable by either surgery or radiotherapy alone. This includes patients with stages IIB, IIIA, IIIB or IVA and stages IB or IIA who in addition have one of the following risk factors:

  * Primary tumor \> 6 cm
  * Positive pelvic and/or para-aortic lymph nodes (resected or unresected)
  * Positive surgical margins
  * Depth of invasion greater than 50 % and positive capillary-lymphatic space involvement
  * Eligible cell types include squamous, adenosquamous and adenocarcinoma of the cervix
* Patients may have measurable disease (defined as lesions which can be measured in at least two (2) dimensions by physical examination or any medical imaging technique). Inability to measure disease will not constitute exclusion criteria.
* Patients with GOG performance status of 0, 1, or 2.
* Patients will have recovered from the effects of recent surgery and should be free of clinically significant infection.
* Patients must have adequate:

  * Bone marrow function: WBC greater than or equal to 3,000 cells/mm3, platelet count greater than or equal to 100,000 cells/mm3, and granulocyte count greater than or equal to 1,500 cells/mm3.
  * Renal function: Creatinine less than or equal to 2.0 mg/dl.
  * Hepatic function: Bilirubin less than or equal to 1.5 x institutional normal, SGOT and alkaline phosphatase less than or equal to 3 x institutional normal.
* Patients must have signed an approved informed consent.
* Patients have met the pre-entry requirements specified in Section 7.0

Exclusion Criteria:

* Patients with GOG performance of 3 or 4.
* Patients with another malignancy, prior or concomitant, other than skin (excluding melanoma).
* Patients with septicemia, severe infection, gastrointestinal bleeding, or intestinal obstruction.
* Patients with anatomic abnormalities requiring modification of radiation fields (pelvic kidney, renal transplant, etc.).
* Patient with recurrent cervical cancer
* Patients who have received prior pelvic radiation
* Pregnant women and women of childbearing potential not using an effective form of contraception.
* History of thrombus (10/28/02)
* History of unstable angina or MI within the past six months. Patients with evidence of abnormal cardiac conduction (e.g. bundle branch block, heart block) are eligible if their disease has been stable for the past six months. (10/28/02)
Search Cytomegalovirus in Healthy Volunteers Stools Samples Selected as Potential Donor for Fecal Microbiota Transplant

Fecal microbiota transplantation (FMT) is recommended in the treatment of recurrent Clostridium difficile infection (CDI). The principle is to administer a fecal suspension of a healthy subject (donor) in the digestive tract of a patient with an CDI (receiver). Donors are being clinical and laboratory screening to reduce the likelihood of pathogens transmission (infectious and other). Cytomegalovirus (CMV) is part of the examinations requested by the Agence national de sécurité du médicament et des produits de santé in the context of clinical research. A sero-matching between donor and recipient CMV is requested. This recommendation eliminates many potential donors to a recipient. To date, the frequency detection level of CMV in stool in healthy volunteers with documented positive CMV serology is not known. In addition, CMV transmission risk via the stool is not established. This study aims to determine the detection frequency of CMV in healthy volunteers stool samples selected as potential donors for a FMT and having a positive CMV serology documented


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged over 18 and under 65 years
* Having a normal transit (less than three stools per day and more than three bowel movements per week)
* Body mass index (BMI) \<30 and\> 16.9
* Accept the constraints of the study, ie two visits (inclusion and Following Visit), a stool sample, two blood tests
* Having given and signed informed consent
* Being affiliated or beneficiary of a social security scheme

Exclusion Criteria:

* Taking a treatment with anti-CMV action in three months by acyclovir, valacyclovir, ganciclovir, valganciclovir, foscarnet, cidofovir, brincidofovir
* Having an absolute exclusion criteria to donation defined by the survey of French Group Fecal Transplant:
* Digestive disorders (acute or chronic diarrhea) in the three months prior to donation
* Known chronic disease (except hypertension and hypercholesterolemia)
* Documented history of typhoid fever
* Taking long-term medication (except contraceptives, cholesterol-lowering and antihypertensive treatment)
* Antibiotic taken within three months
* Stay in tropics during the three months prior to donation,
* Residence of several years in tropics (over 24 months)
* Hospitalization abroad of more than 24 hours in the last 12 months to the donor or his entourage (those living under the same roof)
* Healthy Volunteers who have not reached the limit of compensation by social security or exclusion period