cyrilzakka/clinical-trials huggingface dataset:
Anatomical and Functional Outcome of PSG Vs BMG for Urethral Substitution in Long Segment Anterior Urethral Strictures

This study aims to compare the penile skin graft and buccal mucosal graft for substitution of long anterior urethral strictures using one-sided dorsal perineal approach.

Since previous studies were:

* Retrospective and very few were prospective randomized studies
* Some studies were done on lichen sclerosis cases that have an adverse effect on the PSG outcome.
* The follow-up duration was longer for PSG patients.
* Stricture length was usually longer for PSG cases.

This study aims to compare the PSG and BMG for substitution of long anterior urethral strictures using one-sided dorsal perineal approach.

The investigators hypothesize that:

❶ Conducting a well-designed prospective, randomized study can help identify which technique is better than the other.

❷ Using the one-side dorsal approach can improve the outcomes of both techniques and identify their advantages and disadvantages.

Eligibility Criteria:
Inclusion Criteria:

* The study will include patients with long segment anterior urethral stricture (\>2 cm).

Exclusion Criteria:

* Urethro-cutaneous fistula, urethral abscess or diverticulum.
* A scarred and unsalvageable urethral plate or scarred perineum.
* Lichen sclerosis (Balanitis xerotica obliterans).
* Unhealthy/unavailable buccal mucosa.
Electrical Muscle Stimulation Versus Resistive Training On Physical Measures, And Fatigue In Hemodialysis Patients

The aim of this study is to compare effect of intradialytic NMES versus resistive training on physical measures and fatigue in HDP.

In this study we will compare between the effect of intradialytic neuromuscular electrical stimulation and resistive training on physical measures, dialysis efficiency and fatigue in HDP. This is first study that will compare between NMES and resistive training in HDP, investigating their effect on physical performance; dialysis efficiency and level of fatigue as previous studies show effect of each intervention alone.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes, with CKF on HD for more than 3 years.
* Age between 40 to 55 years old.
* BMI is between 25 and 29.9 kg/m2.

Exclusion Criteria:

Patients who have one of the following contraindications to the interventions or affect the results

* Cognitive impairment that prevented them from performing the evaluations and who were unable to understand and sign the written informed consent.
* Stroke
* Smokers
* Anemic patients
* Osteoarticular or disabling musculoskeletal disorders
* Uncontrolled hypertension (systolic blood pressure\>230 mm Hg and diastolic blood pressure\>120 mm Hg)
* Patients with coronary artery disease or heart failure.
* Diabetic patients
* Infectious diseases and chest diseases
* Active smokers' patients with peripheral vascular disease in the lower limbs such as deep vein thrombosis or thromboangiitis
Efficacy Investigation of the Medical Device Apneal® on Smartphone for Sleep Apnea-Hypopnea Syndrome Diagnosis

The goal of this clinical trial is to evaluate the effectiveness of the Apneal® app in diagnosing sleep apnea syndrome (SAS) in adults who require polysomnography (PSG) as part of routine care. The main questions it aims to answer are:

* Can Apneal® accurately classify the SAS severity into four categories (normal: AHI \< 5, mild: 5 ≤ AHI \< 15, moderate: 15 ≤ AHI \< 30, and severe: AHI ≥ 30) compared to PSG ?
* How does Apneal® perform in estimating the Apnea-Hypopnea Index (AHI), detecting sleep stages, differentiating between central and obstructive apneas, and identifying patient movements?

Participants will:

* Wear the Apneal® app-equipped smartphone and undergo PSG during a full night of sleep at home.
* Complete several questionnaires assessing sleep symptoms and experience with the Apneal® app.


Eligibility Criteria:
Inclusion Criteria:

* Individuals, male or female, aged 18 years or older (no upper age limit).
* Individuals for whom polysomnography (PSG) is indicated as part of routine care, regardless of the specific indication.
* Individuals with a reported total sleep time of at least 6 hours, in accordance with AASM recommendations for PSG analysis.
* Individuals affiliated with social security or benefiting from a similar system, if applicable, in accordance with local regulations.
* Voluntary individuals who have provided oral and written consent after being informed by the research investigator.

Exclusion Criteria:

* Individuals with an active implantable medical device (e.g., electronic cardiac implant, neurophysiological electrical stimulator).
* Individuals with a chest deformity that prevents proper placement of the smartphone on the chest.
* Individuals with uncontrolled psychiatric disorders that prevent them from giving full consent to the study.
* Individuals unable to understand or speak the official language of the research center.
* Individuals currently excluded from another protocol or participating in another interventional research study.
* Vulnerable persons or adults under legal protection, including pregnant or breastfeeding women, persons deprived of liberty by judicial or administrative decision, individuals hospitalized without consent, or admitted for purposes other than research (Articles L1121-5 to L1121-8 of the French Public Health Code).
Plaque Inhibitory Effect of Neutral Electrolysed Water in the Form of a Mouthwash in a 4-day Non-brushing Model

Electrolysed water (EOW) is produced by the electrolysis of sodium chloride in an aqueous solution, producing chlorine gas at the anode and sodium hydroxide and hydrogen at the cathode. EOW is known to have antimicrobial effects against various microorganisms, including viruses, bacteria, spores and fungi. Its antimicrobial activity is generally attributed to its hypochloric acid content - a product of chlorine gas dissolved in water. Due to its biocompatibility, known uses of EOW include ocular disinfection, nasal irrigation and chronic cutaneous wound care. In the dental setting, it may be used as a mouthwash, disinfectant, irrigant, mouthwash or dental gel.

The aim of this study is to investigate the effect of a mouthwash containing neutral electrolyzed water on plaque accumulation (evaluated using a disclosing agent and an intraoral scanner), gingival inflammation, MMP-8 activity and the oral microbiome. In this double-blind, cross-over, 4-day experimental gingivitis model, each subject will participate in all three arms of the study. Each arm will last 4 days, during which the subjects will be asked to refrain from toothbrushing and the use of interdental cleaning devices. Instead, they will be instructed to rinse their oral cavities twice daily with either EOW, placebo or a positive control (chlorhexidine), according to a randomisation chart (each subject will receive a different mouthwash type in every arm of the study). The outcomes will be assessed at baseline and after 4 days. A washout period of at least 7 days will be implemented between each study arm.


Eligibility Criteria:
Inclusion criteria:

* age 20 - 30 years,
* non-smoker,
* systemically healthy,
* without regular systemic medication,
* presence of at least 6 teeth in each jaw quadrant,
* plaque index \< 10 % at baseline visit,
* absence of periodontal pockets measuring \> 4 mm.

Exclusion criteria:

* known allergy or suspected hypersensitivity to chlorhexidine digluconate,
* gingivitis,
* regularly use of mouthwash as part of oral hygiene routine,
* antibiotic treatment in the last 6 months or during the observation period,
* pregnancy or lactation,
* fixed or removable prosthetic devices, dental implants.
Sympathetic Activation in Obesity

The primary objective of this study is to determine whether sympathetic nervous system (SNS) activity in white adipose tissue (WAT) and brown adipose tissue (BAT), skeletal muscle and brain is altered in individuals with obesity in comparison to individuals with normal weight. Simultaneous multi-organ SNS activation will be obtained with a radiotracer for norepinephrine transporter (NET) for whole-body Positron Emission Tomography (PET) imaging and microneurography (peroneal muscle SNS activity).

The secondary objectives of this study are: 1) to evaluate whether gender differences affect peripheral SNS in healthy normal weight and obese men and women in adipose tissue (WAT and BAT) and muscle (resting/fasting); 2) To investigate the relationship between peripheral and central SNS activity in obesity, by correlating SNS activity in peripheral tissues (WAT, BAT, and muscle) and brain; and 3) To investigate NET CNS and peripheral SNS activity before and after a high carbohydrate mixed meal in lean and obese men and women.


Eligibility Criteria:
Inclusion Criteria:In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Age 18-45 years
4. In good general health as evidenced by medical history and lean (BMI 18.5-24.9 kg/m2) or non-diabetic obese (BMI 30-50 kg/m2) with a fasting plasma glucose (FPG) \<100 mg/dL and a hemoglobin A1c \<5.7%.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Hypertension
2. Cardiac or pulmonary disease,
3. Known history of Type 1 or Type 2 diabetes
4. Hepatic disease, swallowing and gastrointestinal disorders
5. Current use of anti-obesity medications, supplements and/or anti-hyperglycemic medications
6. Neurological injury or illness, and psychiatric medications
7. Women who are pregnant or lactating
8. Subjects who suffer from claustrophobia
9. Subjects who have received a diagnostic or therapeutic radiopharmaceutical within 7 days prior to participation in this study
10. Radiation works or participation in other research studies involving ionizing radiation within one year of the PET scans that would cause the subject to exceed the yearly dose limits.
11. Subjects with history of IV drug use which would prevent venous access for PET tracer injection
12. Severe motor problems that prevent the subject from lying still for PET and MR imaging
13. Subjects who complain of chronic pain
14. Blood donation within 8 weeks of the study
Effectiveness of D-Cycloserine as an Aid to Enhance Learning for Individuals With OCD Receiving Behavior Therapy

This study will assess the effectiveness of Seromycin (D-cycloserine) in enhancing the positive effects of behavior therapy for people with Obsessive-Compulsive Disorder (OCD).

We hope to enroll 50 subjects in a double-blind, placebo-controlled study of D-cycloserine augmentation of behavior therapy for Obsessive-Compulsive Disorder. All subjects will undergo a pre-treatment assessment, and then be randomly assigned to receive Seromycin (100 mg) or placebo one-hour before each of 10 therapy sessions. Subjects will then come in for a treatment planning session and the behavior therapy sessions delivered twice weekly for 5 weeks. Comprehensive assessments of obsessive-compulsive symptoms, mood state, and cognitions will be given at baseline, after 5 treatment sessions, after 10 sessions and 1 month and 6 months post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Structured Clinical Interview for DSM-IV (SCID) diagnosis of Obsessive Compulsive Disorder
* Score of greater than 16 on the Yale-Brown Obsessive Compulsive Scale
* Negative urinary beta-Human Chorionic Gonadotropin (hCG) test

Exclusion Criteria:

* Currently taking or have taken an unstable dose of psychotropic medications within 2 months prior to enrollment
* Currently taking medications that may interfere with the study medication
* History of seizure disorder or other serious medical illnesses (e.g., cardiovascular, liver, kidney, respiratory, endocrine, neurologic, or blood-related disease)
* Current diagnosis of tuberculosis
* Other psychiatric diagnoses (e.g., alcohol dependence, bipolar disorder, psychosis, organic mental disorder, or development disorder) that are of greater concern than the obsessive-compulsive disorder diagnosis
* Currently taking medications that may lower seizure threshold (e.g., including clozapine, pethidine, and the following antibiotics in high dosage: penicillins, cephalosporins, amphotericin, and imipenem)
* Poses a serious suicidal or homicidal threat
* Currently undergoing psychotherapy
* Failure to benefit from ten or more sessions of previous Exposure and Response Prevention (ERP) treatment
* Pregnant or breastfeeding
The Effect of Influenza Vaccination on the Systemic Inflammatory Response and Myocardial Protection in Patients Undergoing Cardiac Surgery: a Randomized Controlled Trial

To assess the impact of influenza vaccination on the overall systemic inflammatory response in patients undergoing cardiac surgery and investigate functional and clinical outcomes in vaccinated patients postoperatively.

The investigators propose to perform a single center, double-blind, randomized, placebo-controlled crossover trial analyzing the beneficial effect of the influenza vaccine in patients undergoing cardiac surgery. This study assesses the impact of the influenza vaccination on the overall systemic inflammatory response and investigates the functional and clinical outcome in vaccinated patients after cardiac surgery. The study sample will consist of patients undergoing cardiac surgery at Health Sciences North randomized into 2 groups: 1) those who receive the vaccine or placebo preoperatively, or: 2) those who receive the vaccine or placebo 4-6 weeks postoperatively. Subjects in both groups will be compared using standard laboratory tools to assess the level of various pro- and anti-inflammatory cytokines (IL-6, IL-8,TNF-alpha, IL-10) as well as other cardiac and inflammatory markers (troponins, CRP), at different time intervals intra- and post-operatively. Other clinical outcomes will also be collected prospectively and compared between the 2 groups. These include hemodynamic parameters as well as major postoperative events. Further assessments will include the Frailty Index and Scale (in patients 65+) and length of stay after surgery

Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes can and will comply with the requirements of the protocol (i.e. return for follow-up visits, and able to converse with study personnel)
* Age 18 years or older
* Undergoing major cardiac surgery using cardiopulmonary bypass

Exclusion Criteria:

* Have not received influenza vaccination in the past or cannot be vaccinated due to previous severe reaction to influenza vaccine, egg, latex, or thimerosol allergies, or refusal of vaccination
* Participant has received a community available influenza vaccine within \<6 months
* History of Guillain-Barré syndrome
* Immunosuppressive disorders or medications (including oral prednisone \>10 mg daily, recent chemotherapy treatment)
* Emergency cases as determined by the investigator or physician
A Long-Term Safety Study of OZURDEX® in Clinical Practice

This study is a multicenter, prospective, observational study to evaluate the long-term safety of OZURDEX® in patients with macular oedema following central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO) or patients with non-infectious posterior segment uveitis in real-world clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Macular oedema following either BRVO or CRVO or non-infectious uveitis
* Requires treatment with OZURDEX®

Exclusion Criteria:

* Current participation in any clinical study
Baseline Epidemiologic Assessment of Abuse-Deterrence of MorphaBond Extended Release (BEAD-MB)

The main objectives of this study are to provide surveillance/descriptive data to (a) assess utilization of MorphaBond ER and selected comparators overall and by age group and census regions using nationally-projected quarterly drug dispensing data and (b) assess the scope and pattern of abuse and clinical outcomes for MorphaBond ER using nationally representative data or data from large geographic areas in different populations.

Findings of this study will support the design of formal epidemiology assessment of the risks of addiction, overdose, and death outcomes associated with MorphaBond ER and appropriate comparators in the future.

The study started after the launch of MorphaBond ER in October 2017 and will continue until September 2020 and the final study report will be submitted to the FDA by December 2020.

This is an observational study that will provide descriptive data on the utilization and abuse of MorphaBond ER and related outcomes (addiction, misuse, abuse, overdose, overdose-related deaths) for MorphaBond ER and selected comparators in response to the US-FDA's post-marketing requirement (PMR 2961-9 for MorphaBond ER).

No investigational products or pharmaceutical agents will be provided or administered for the purpose of this study. Multiple data sources, representing different populations and large geographic areas in the US, will be utilized to study the patterns of MorphaBond ER utilization and abuse and related outcomes.

The overall purpose of this study is to collect meaningful baseline data to support subsequent studies for formal epidemiologic assessment of abuse deterrence of MorphaBond ER as required by the FDA.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* MorphaBond ER users or relevant comparator users

Exclusion Criteria:

* Not applicable
Preventing Diabetic Osteoporosis With Exercise

The two specific aims of the study were to determine whether:

1. Greater mechanical loading of downhill exercise will increase the osteogenic index (ratio between CICP, the marker of bone formation (c-terminal propeptide of type I collagen, and CTX, the marker of bone resorption (c terminal telopeptide of type I collagen)) to a greater extent than uphill exercise that provides lower ground-reaction force;
2. Exercise after the meals will induce greater osteogenic response than exercise pefore the meals as it is known that meal eating during daytime inhibits bvone resorption markers.

The study addresses the problem that postmenopausal women with type 2 diabetes have a higher incidence of bone breaks despite their often normal bone mineral density (BMD).

The investigators pursued two hypotheses, that:

1. 40-minute bout of downhill exercise will increase the CICP/CTX osteogenic index to a greater extent than the same amount of uphill exercise; and
2. Performing exercise one hour after the meals will be more osteogenic than exercise before the meals.

Subjects were 15 postmenopausal women with type 2 diabetes, age 57.7 years, BMI 27.2 kg/m2 who were randomly assigned to two out of 5 trials:

Uphill exercise before the meals (UBM), Uphill exercise after the meals (UAM), Downhill exercise before the meals (DBM), Downhill exercise after the meals (DAM), and Sedentary, no-exercise, trial (SED). All subjects signed an informed consent approved by the University of Michigan Medical School Institutional Review Board. Subjects had their BMD measured with DXA at the outset.

Weight-maintenance meals contained 50% carbohydrate, 15% protein, and 25% fat and were provided at 10 h and 17 h. Exercise (40 minutes at 50% of maximal effort) on either uphill (+6o slope) or downhill treadmill (-6o slope) was performed either before the two meals, at 9 h and 16 h, respectively, or after the meals. at 11 h and 18 h, respectively.

Blood was drawn through an intravenous catheter from ante-cubital vein at hourly intervals between 8 and 20 h with two additional blood draws at 0 h and 6 h the next morning. Blood was treated with protease inhibitors, and plasma, frozen at -80o C, was used to measure bone markers, CICP, CTX, osteocalcin , and bone-specific alkaline phosphatase using Millipore chemoluminescen reagents, glucose by glucose oxidase, and hormones insulin, cortisol, parathyroid hormone (PTH) , and growth hormone (GH) by radio-immunoassays..

Mixed-model ANOVA was used for analysis of outcome measures where the trial procedures served as fixed variable and individual subjects as intercept variables.

Eligibility Criteria:
Inclusion Criteria:

postmenopausal type-2 diabetes melllitus age between 50 and 65 exercise less than 20 minutes three times a week

Exclusion Criteria:

metabolic disease other than type-2 diabetes and hormonally-corrected hypothyroidism musculo-skeletal disability that would preclude exercise smoker do not meet inclusion criteria
Establishment of Drug-induced Liver Injury Databases and Application of Circulating microRNA(miRNA)

The purpose of the study is to establish drug-induced liver injury databases in China, make criteria for Chinese drug-induced liver injury patients and evaluate the application of certain circulating miRNA in diagnosis or treatment of drug-induced liver injury.

Firstly, this study collects some retrospective data. Analyse these data and establish certain unique diagnostic criteria for Chinese. Then collect prospective data and validate the criteria. Otherwise,collect blood sample or other sample of the patients and study certain miRNA in diagnosis or treatment of drug-induced liver injury.

Eligibility Criteria:
Inclusion Criteria:

* Males and females between the age of 18 to 70 years
* Women in child-bearing period taking some contraception measures
* Patients with onset of acute liver injury attributed to antituberculosis drugs or antineoplastic drugs, Roussel Uclaf Causality Assessment Method（RUCAM ） score≥6
* Written informed consent can be obtained, some patients agree with liver biopsy

Exclusion Criteria:

* Viral hepatitis
* Alcoholic liver disease or non-alcoholic liver disease
* Wilson's disease or other inherited metabolic liver diseases
* Auto-immune liver diseases
* Any dysfunction of liver
* Malnutrition
* Chronic diseases such as HIV,severe heart diseases, severe brain diseases or chronic kidney diseases
* Patients who can not complete follow-ups on time
Mindfulness-based Intervention Versus CBT for Social Anxiety Disorder

To conduct a prospective, randomized trial to compare the efficacy of a group mindfulness-based intervention adapted for social anxiety disorder (MBI-SAD) versus cognitive behavior group therapy (CBGT).

The main aim of this comparative trial is to determine if the MBI-SAD will be noninferior to CBGT in improving core symptoms of social anxiety disorder, depressive symptoms, self, esteem, disability and quality of life. A secondary aim is to examine whether treatment gains are maintained over a 6-month period. Exploratory aims of the study are to: 1) determine if the MBI-SAD enhances self-compassion and mindfulness relative to CBGT; 2) determine if changes in self-compassion and mindfulness mediate the clinical response to the MBI-SAD; and 3) explore moderators of treatment response.

Eligibility Criteria:
Inclusion Criteria:

* DSM-5 diagnosis of social anxiety disorder (SAD) of at least moderate severity
* Montgomery Asberg Depression Rating Scale score ≤ 25
* Comorbid depressive disorders, panic disorder, agoraphobia, generalized anxiety disorder, specific phobias, eating disorders are allowed as long as the SAD is primary and predominates the clinical picture.

Exclusion Criteria:

* Coexisting Axis I disorders excluding those listed in the inclusion criteria
* Coexisting medical conditions that can alter the clinical presentation of SAD (e.g. Parkinson's disease)
* Lifetime history of bipolar disorder or psychotic symptoms
* Substance-related disorders in the last 12 months
* Acutely suicidal or history of suicide attempt in the past five years
* History of non-suicidal self-injurious behavior in the last 12 months
* Currently receiving psychotherapy
* Currently engaged in a regular meditation or yoga practice
* Unable to attend weekly group sessions