cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Laser Therapy on Proximal Hamstring Tendinopathy

Proximal hamstring tendinopathy (PHT) is tendinopathy of the semimembranosus and/or biceps femoris/semitendinosus complex. Previous studies have shown the efficacy of laser therapy in the treatment of tendinopathy. To the best of the investigator's knowledge, no study has compared the effects of high-power LASER therapy with conventional physiotherapy programs in proximal hamstring tendinopathy patients. Therefore, this study aimed to assess the effects of high-power laser therapy on pain and muscle power in proximal hamstring tendinopathy patients.

2 arms comparative pretest-posttest experimental research design with random allocation of subjects into groups (experimental and control group) using the lottery method. A total of thirty-six participants aged between 18-35 (mean age) years, were recruited in the present study. The selected participants were randomly allocated into experimental and control groups using the lottery method and website randomization.com with eighteen participants in each group. The participants and outcome assessor were kept blinded to the allocation. In the experimental group, the high-power laser was given whereas in the control group conventional physiotherapy treatment was given for 4 weeks. Conventional physiotherapy treatment included the US, moist heat pack, and home exercises. Home exercises include nordic hamstring exercises - 2 sets of 5 repetitions, 3 days/week for 3 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Athletes
* pain located deep in the buttock/posterior thigh region
* tenderness of ischial tuberosity
* hamstring muscle tightness.

Exclusion Criteria:

* Recent trauma to the posterior thigh
* Musculoskeletal disorder of ipsilateral lower extremity
* taking pain medication daily
* hypertension, malignancy, autoimmune disease, phlebitis, blood disorder.
Role of ACTG2 Variants in Smooth Muscle Determination and Function in Pediatric Intestinal Pseudo-obstruction.

The primary objective of this study is to describe the transcriptional impact of R178, R257, R40 or A136 variants of the ACTG2 gene on iPS differentiation mechanisms up to organoids derived from PIPO patient samples versus those derived from control / WT patients (generation of IPS from cultured cell lines), at different stages of their experimental ex vivo development.

Recruited patients will be sampled during a consultation: a blood sample and a biopsy will be taken directly from the patient. Once these samples have been taken, they will be cultured to be reprogrammed into iPS cells, then grown and differentiated into intestinal organoids.

Various experiments will be carried out (as described in the outcomes) to identify at molecular, cellular and tissue level the mechanisms altered in patients with an R178, R257, R40 or A136 variant, assessing their consequence(s) on the development and functionality of the digestive mesenchyme.

Eligibility Criteria:
Inclusion Criteria:

PIPO Population:

1. Minor or adult patient ≥ 4 years of age
2. Patient with PIPO before age 18
3. Male or female
4. Patient with PIPO meeting at least 2 of the ESPGHAN criteria (Thapar et al 2018) and carrying the R178, R257, R40 or A136 mutation of the ACTG2 gene.
5. Patient whose assent has been obtained and whose legal guardians have given their written informed consent
6. Patient affiliated to the French Social Security system or benefiting from an equivalent plan

WT population:

- iPS cell lines MS573 or WT8288 or 202CT or SD378M, from the Nantes University Hospital biological collection and generated from samples from control patients without POIC who have consented to donate their samples.

Exclusion Criteria:

PIPO population :

1. Patients with a history of radiotherapy treatment
2. Patient with lymphocyte lineage damage
Meniere Disease and Hearing Aids

Patients with unilateral Meniere Disease often a distortion that causes difficulties to provide hearing aids to these patients. Those patients have two main problems: disorders in noise comprehension due to interaural threshold difference and increase in the distortion during dizziness crisis.

Due to these problems, some people cannot be fitting with hearing aids because the compression needed is too high or the discomfort in noise is not bearable for patients.

Our aim is to evaluate and to propose a way to adjust hearing aids to restore binaural hearing with comfort.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 y.o
* Meniere disease as define by the Barany Society
* Unilateral deafness with a threshold over 50dB
* Normal ear with a threshold above 30dB
* Interaural threshold difference of at least 30dB
* Patient who has already an hearing aids and satisfied with it

Exclusion Criteria:

* Absence of consent of the patient or not able to give it
* Patient with hearing aids well fitted
Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction

The purpose of the study is to study the outcomes of maternal and fetal patients who are undergoing fetal intervention for severe isolated lower urinary tract obstruction (LUTO).


Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women
2. Singleton pregnancy
3. Maternal age ≥ 18 years
4. Male fetus with LUTO, dilated bladder, "keyhole sign" and bilateral hydronephrosis
5. Oligohydramnios or Anhydramnios
6. Favorable urine analysis defined as urinary sodium is \< 100 milliequivalents per liter (mEq/L), chloride \< 90 mEq/L, and osmolality \< 200 milliosmoles per kilogram (mOsm/kg) after 20 weeks and in the absence of previous in utero intervention for the disease (vesicoamniotic shunt placement or fetal cystoscopy).
7. Absence of chromosomal abnormalities and associated anomalies
8. Gestational age at the time of the procedure will be between 16 0/7 weeks and 25 6/7 weeks
9. Normal karyotype by invasive testing (amniocentesis or Chorionic Villus Sampling (CVS)). Patients declining invasive testing will be excluded.
10. Family have considered and declined the option of termination of the pregnancy at less than 24 weeks.
11. Family meets psychosocial criteria, including sufficient social support and ability to understand requirements of the study.
12. Parents or guardian are willing to provide signed informed consent.

Exclusion Criteria:

1. Fetal anomaly unrelated to LUTO
2. Congenital cardiac anomaly
3. Female fetus
4. Increased risk for preterm labor including short cervical length (\<1.5 cm), history of incompetent cervix with or without cerclage, and previous preterm birth
5. Placental abnormalities (previa, abruption, accreta) known at time of enrollment
6. Contraindications to surgery including previous hysterotomy in active uterine segment
7. Technical limitations precluding fetoscopic surgery, such as uterine fibroids, fetal membrane separation, uterine anomalies incompatible with fetoscopy
8. Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy
9. Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment
10. Maternal medical condition that is a contraindication to surgery or anesthesia
11. Patient does not have health insurance to cover routine clinical care including prenatal care, prenatal ultrasound, amniocentesis, tocolysis, admission, delivery, and fetal vesico-amniotic shunting. The exception will be fetal cystoscopy which is considered an experimental procedure.
12. Inability to comply with travel and follow-up requirements of the trial
13. Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy
14. Patients declining invasive testing
15. Family does not meet psychosocial criteria including insufficient
Care for Late Stage Parkinsonism

The aim of this project is to evaluate the needs and provision of care for patients in the late stages of Parkinsonism and their carers in several European countries, to compare the effectiveness of different health and social care systems, and to lay the foundation for improved outcomes in this population. The investigators will undertake an in-depth assessment of patients and their care arrangements in a population recruited through networks in six European countries. The systems and procedures that are used in the provision of care will be reviewed through a systematic literature review, interviews and assessments of patients, carers and health care providers, and through a trial comparing assessment by a specialist with management suggestions, guidance and access to telephone advice to that of usual care. Through interviews, questionnaire assessment and review of current health-care and social care arrangement, the investigators will assess the needs, provision of care and use of health-care resources, and their impact on patient and carer outcomes in different countries. National and regional databases will also be interrogated to identify current practice and use of healthcare resources and drug usage. A systematic literature review of the evidence for effective management strategies, analysis of the study data, and evaluation of change in outcomes following specialist review will provide the basis for recommendations in the management of late stage Parkinsonism. The investigators will also evaluate potentially useful outcome measures for use in this patient group. In addition to charting the needs and current care provision for late stage Parkinsonism in different European countries, its cost and effectiveness, and an analysis of health-care and social care predictors of improved outcome, the project will produce a platform for the assessment of patients with late stage Parkinsonism, their current treatment and care provision, as well as guidelines on the management of this late disease phase.


Eligibility Criteria:
Inclusion Criteria:

* Hoehn and Yahr stage (HY) IV or V in the "On"-state
* Disease duration of at least 7 years

Exclusion Criteria:

* Symptomatic Parkinsonism
Protective Effect of N-acetylcysteine Against From Ototoxicity

Peritonitis is currently one of the leading complications of continuous ambulatory peritoneal dialysis (CAPD). Aminoglycosides and vancomycin are used in the treatment of CAPD peritonitis despite their potential risk for ototoxicity. NAC is a molecule used in the treatment and prophylaxis of many diseases related to oxidative stress. The aim of this study was to examine whether ototoxicity due to antibiotics used in the treatment of CAPD peritonitis can be prevented by N-acetylcysteine

NAC, a thiol-containing antioxidant because of this,we want to investigate antioxidant status.

Eligibility Criteria:
Inclusion Criteria:

* End-stage renal disease
* Undergoing continuous ambulatory peritoneal dialysis as a renal replacement therapy
* Developing the first continuous ambulatory peritoneal dialysis related peritonitis episode

Exclusion Criteria:

* Being treated with aminoglycoside antibiotics and vancomycine within the previous 3 months
* Detection of mechanical occlusion of external ear
* Having signs of disturbed integrity of tympanic membrane on otoscopy or tympanometry
* History of a continuous ambulatory peritoneal dialysis related peritonitis
Safety and Efficacy Study of USTRAP™ in Male Urinary Incontinence

Few surgical methods to treat male stress urinary incontinence have been assessed in comparative, randomised interventional studies.

Ustrap is a new adjustable-pressure 4-arm device. The artificial sphincter is currently considered the gold standard device in this field.

The aim of this randomised prospective international study is to assess the efficacy and safety of the Ustrap® device comparatively with an artificial sphincter (AMS800) in the treatment of stress urinary incontinence following prostate removal in cancer patients.


Eligibility Criteria:
Inclusion Criteria:

Disease-related criteria:

* persistent urinary incontinence \>= 12 months following radical prostatectomy for prostate adenocarcinoma
* presenting an indication for surgical insertion of a medical device
* 24h PAD test \> 100 g per day
* controlled prostate adenocarcinoma, with PSA ≤ 1 ng/ml

Population-related criteria:

* male subjects aged 18 years and over
* having provided free, informed written consent to take part in the study
* patients independent and able to use the collar without difficulty and able to manage an artificial sphincter
* Patient able to understand and sign the consent form and to complete questionnaires
* Patient without mental impairment
* Patients belonging to or covered by Social Security.

Exclusion Criteria:

Disease-related criteria:

* Documented neurological bladder or history of neurological disease liable to interfere with urinary symptoms.
* Presence of urethral anastomotic stenosis preventing passage of the fiberscope at the initial endoscopy
* Severe symptomatic hyperactive or hypoactive bladder not controlled by drug therapy
* Severe constitutional haemorrhagic disease or haemophilia
* Patients presenting urinary infection not controlled
* Patients presenting severe renal failure and obstructive pathologies of the upper urinary tract with severe renal failure.
* Patients presenting deep immune deficiency
* Patient presenting recto-urethral fistula
* Patient with tumor of bladder
* Patient having bladder stones with failure of bladder stone treatment

Criteria related to incontinence treatment:

* Allergy to any of the components of the medical devices
* History of surgery to insert a medical device for treatment of incontinence (e.g. artificial sphincter, suburethral strap, continence balloons, etc.)
* History of periurethral injection of filling agents
* Inability to use either of the study devices
* Drug treatment: duloxetine or any treatment likely to modify continence results
* Not receiving and not likely to receive radiotherapy at any time throughout the 12-month follow-up period Population-related criteria
* Foreseeable unavailability during the study . Patient deprived of liberty by administrative or judicial decision or under legal guardianship
* Participation in another clinical trial in the 3 months preceding the initial visit
Correlation Between Intestinal Microbiota, Inflamatory Biomarkers, Intestinal Morphology, Hepatic Fibrosis Degree and Vascular Reactivity.

This project aims to establish the correlation between intestinal microbiota with inflammatory biomarkers, intestinal morphology, vascular reactivity and degree of hepatic fibrosis in patients with different degrees of glucose tolerance and body adiposity.

Obese patients with dysglycemia or not, from the Obesity Outpatient Clinic, and individuals with normal or overweight weight with dysglycemia or not, preferably from the same social class and type of diet of the obese will be invited to participate in the study. Dysglycemia will be defined by the criteria of the Brazilian Society of Diabetes. These individuals will be divided into four groups: obese with dysglycemia (OBD), obese with normoglycemia (OB), lean / overweight with dysglycemia (MD) and lean with normoglycemia (M). After the selection and signing of the informed consent, the patient will be referred for an anthropometric evaluation, with the measurement of body mass and height, waist circumference and determination of body fat by the bioimpedance method Biodynamic 450 (BioDynamics , Seattle, USA). Finally, the 24-hour reminder (R24h) will be applied as a food survey method. And the dietary calculation will be performed through the AVANUTRI® diet calculation program (Rio de Janeiro, Brazil). Clinical parameters will include: age, sex, BMI, presence of comorbidities, use of medications, gastrointestinal complaints, previous surgeries and smoking (absent, present, prior). Only after approval by the Research Ethics Committee (CEP) of the Pedro Ernesto University Hospital (HUPE-UERJ), will this recruitment begin.

Eligibility Criteria:
Inclusion Criteria:

* Men or women between 18 and 50 years old
* BMI between 30-40kg / m2 with and without diabetes or altered glucose tolerance
* BMI between 18-24.9 kg / m2 without diabetes or altered glucose tolerance

Exclusion Criteria:

* Acute disease
* Chronic pulmonary, cardiovascular, haematological, gastrointestinal, hepatic or renal diseases;
* Unstable dietary history, defined as major changes in diet during the previous month diagnosed by a specialist nutritionist;
* History of gastrointestinal disturbances in activity or chronic diseases, including - inflammatory bowel diseases (IBD), chronic diarrhea of unknown etiology, chronic constipation, disabsorbing syndromes,
* History of major gastrointestinal tract surgery, except cholecystectomy and appendectomy;
* Use of the following medications: probiotics in the last 6 months, systemic antibiotics, oral corticosteroids, cytokines, methotrexate or cytotoxic immunosuppressive agents, consumption of large doses of commercial probiotics (greater than or equal to 10 8 CFU or organisms per day)
* Positive tests for HIV infection and hepatitis B and C;
* Pregnant and lactating women;
* Smokers
* Chronic alcoholism.
Evaluating Pharmacokinetics and Pharmacodynamics of Jusline

To evaluate the pharmacokinetic and pharmacodynamic profile of a new human insulin (Jusline) after subcutaneous administration, and to compare this profile with Humulin insulin.

To study the pharmacokinetic and pharmacodynamic profile of a new human insulin (Jusline) after subcutaneous administration in the abdominal, and to compare this profile with Humulin insulin for three different preparations (Regular, NPH, and Premixed Regular/NPH (30/70)).

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Non-diabetic
* Age 18-35 year
* Normal body mass index (BMI 18-25 kg/m2)

Exclusion Criteria:

* Diabetics
* Overweight/obese
* Anemic, with liver, cardiac, renal or thyroid dysfunction
Exposure Therapy For Veterans With PTSD And Panic Attacks

To evaluate the feasibility, acceptability and effectiveness of Multiple Channel Exposure Therapy-Veterans (MCET-V) as a treatment for returning service members with comorbid PTSD and panic disorder (PD). This study will examine the effectiveness of MCET-V by comparing it to Cognitive Processing Therapy, a standard PTSD treatment.

With the increasing number of Operations Iraqi Freedom and Enduring Freedom (OIF/OEF) Veterans returning from war-zone areas, many will experience anxiety disorders such as PTSD and comorbid problems. Currently, about one in every six OIF/OEF Veterans experiences PTSD and co-occurring PD. Although effective treatments exist for treating one or the other, we do not yet have treatments that can simultaneously target PTSD and PD. Thus, recent attention has focused on the development of multi-component treatments that simultaneously address PTSD and PD. This study is the first systematic investigation of a time-limited, multi-component cognitive-behavioral treatment for Veterans with specific comorbid anxiety problems. The purpose of the study is to evaluate the effectiveness of the multi-component cognitive-behavioral treatment in comparison to standard PTSD treatment in military personnel returning from active duty.

Eligibility Criteria:
Inclusion Criteria:

* being a Veteran of any era;
* being enrolled in the TRP at the MEDVAMC, with a current diagnosis of PTSD and PD;
* being stable on psychotropic medication for 4 weeks before study participation; and
* being at least 18 years of age.

Exclusion Criteria:

* active substance dependence, or bipolar or psychotic disorders;
* severe depression and \[active suicidal ideation and intent\] (based on ADIS-IV \& BDI-II);
* cognitive impairment as indicated by the SLUMS; and
* Veterans currently receiving psychosocial treatment specifically targeting PTSD or panic symptoms.
DEFILE-QoL5 - Evaluation of the Long-term Surgical Management of the Thoraco-brachial Displacement Syndrome

The study concerns patients hospitalized in vascular and thoracic surgery in 2016 at the University Hospital of Angers for the management of a thoraco-brachial outlet syndrome. It includes all vascular and neurological manifestations related to intermittent or permanent compression of the vasculo-nervous bundle of the upper limb. Before and after the operation, these patients had agreed to complete the quality of life questionnaires, the Disabilities of the Arm, Shoulder and Hand questionary (DASH) and the Short-Form 12 (SF-12). The objective of the present study is to evaluate the long-term quality of life, using the questionnaires mentioned above, completed by 54 patients treated surgically for thoraco-brachial outlet syndrome and who participated in the DEFILE-QoL study in 2016.

All patients included in the DEFILE-QoL study (in 2016) receive an information letter. Without opposition from them after 4 weeks, they are contacted by telephone. The telephone interview begins with an explanation of the study and a time to answer any questions from the patient.

If they agree to participate, they answer the DASH and the SF-12 questionnaires, for an estimated duration of 15 minutes. Following the telephone interview, the patient's participation in the study was terminated.

The date of the information and the patient's non-objection are documented in the patient's source file.

Eligibility Criteria:
Inclusion Criteria:

* Adult
* having participated in the initial study : "DEFILE-QoL"

Exclusion Criteria:

* opposing participation in the research
* unable to answer questionnaires
EGCG for Hepatocellular Carcinoma Chemoprevention

This phase II trial tests epigallocatechin gallate (EGCG) for its efficacy and safety in preventing development of hepatocellular carcinoma (HCC) in patients with liver cirrhosis.

This study will evaluate whether EGCG favorably modulate an HCC risk biomarker (PLSec) with acceptable safety profile in patients with compensated cirrhosis and elevated HCC risk determined by clinical variable-based score (FIB-4 index) and PLSec. Sixty participants will be randomized (1:1) to either the study drub or placebo arm and receive the treatment for 24 weeks. The participants will orally take EGCG 600 mg capsules or placebo for the first 12 weeks. If an interim PLSec analysis at the end of week 8 is not improved without any dose-limiting adverse events, the dose will be increased to 800 mg for the second 12 weeks. If the interim PLSec is improved, 600 mg will be continued. After completing the 24-week treatment, change in the PLSec test with the treatment is calculated by comparing pre- and post-treatment serum samples in each patient, and the changes will be compared between the treatment arms (primary endpoint). Complete adverse event profiles will be recorded, and change in quality of life will be compared between the treatment arms (secondary endpoints). If optional paired liver biopsy tissues are obtained, changes in tissue-based HCC risk biomarker (PLS) and immunohistochemical markers of cell proliferation, neoplasm, senescence, and fibrogenesis will be determined, changes in the FIB-4 index and liver stiffness measurement will be determined, and association with incident HCC during the study period will be evaluated (exploratory endpoints).

Eligibility Criteria:
Inclusion Criteria:

* Adults (≥ 18 years-old)
* Clinically and/or histologically diagnosed cirrhosis
* No active hepatic decompensation
* No prior history of HCC
* Adequate hematologic, hepatic, and renal function
* Karnofsky performance status score ≥70
* Both sexes and all racial/ethnic groups will be considered
* FIB-4 index \> 3.25
* High-risk PLSec at baseline
* Absence of HLA-B\*35:01

Exclusion Criteria:

* Prior or ongoing use of EGCG
* History of adverse reaction to green tea products
* Severe obesity (BMI \> 40 kg/m2)
* Active drinking
* EGCG treatment \<4 weeks or \<80% of planned regimen at the end of week 4
* HCC development during the study