cyrilzakka/clinical-trials huggingface dataset:
Association of Functional COMT Val108/Met Polymorphism With Smoking Cessation in Nicotine Replacement Therapy

Nicotine replacement treatment (NRT) can be efficacious for smoking cessation, but used by only a minority of smokers in China. Pharmacogenetic matching may improve treatment outcomes for NRT in subgroups of smokers. The investigators evaluated the efficacy and safety of sublingual nicotine tablets (SNT) for smoking cessation and the association of catechol-O-methyltransferase (COMT) genotype with efficacy in this smoking cessation trial among Chinese smokers.

All subjects provided written informed consent after a full explanation of the protocol design.

Eligibility Criteria:
Inclusion Criteria:

* Subjects motivated to stop smoking and Han Chinese
* aged 20-70 years who lived in the Haidian District of Beijing
* smoke ≥10 cigarettes/day
* have smoked for ≥3 years
* carbon monoxide (CO) level ≥10 p.p.m. in exhaled air

Exclusion Criteria:

* a history of "Diagnostic and Statistical Manual of Mental Disorders-fourth Edition" (DSM-IV) psychiatric disorder
* alcohol abuse and other drug abuse
* with pathological changes in the floor of their mouth
* cardiovascular disease
* taking psychotropic medications
* using other forms of tobacco or any other NRT products during the last 6 months
* pregnant or breast-feeding
The Impact of Right Ventricular Pacing on Tricuspid Regurgitation

"1" To examine whether right ventricular pacing has an impact on tricuspid regurgitation grade that is related to pacing rather than to valve closure interference by the electrode.

"1" Traditionally, tricuspid regurgitation in the presence of pacemaker is attributed to the physical interference of the valve closure by the electrode.

"2" Right ventricular pacing may be associated with dyssynchrony in contraction of the right ventricular wall (i.e. septum and free wall.

"3" The tricuspid sub-valvar apparatus is anchored to the septum and free wall, thus may be sensitive to dyssynchrony in those wals contraction.

"4" The study hypothesis is that the dyssynchrony in right ventricular contraction, induced by pacing, may increase tricuspid regurgitation grade and that this is a mechanism is independent of the mechanical effect of the electrode on the valve closure.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Permanent pacemaker

Exclusion Criteria:

* Epicardial pacing
* Left ventricular dysfunction
* Organic tricuspid regurgitation
* Bi-ventricular pacemaker
* Atrial fibrillation
* Complete pacemaker dependence
Darifenacin x Parasacral Transcutaneous Electric Nerve Stimulation for OAB in Patients Infected With Human T-Lymphotropic Virus 1

In this study the investigators compare the parasacral transcutaneous electric nerve stimulation (PTENS) treatment with Darifenacin to improve OAB symptoms in patients infected with HTLV-1.

Subjects presenting OAB according to ICS, associated with the HTLV-1 infection were invited by the investigators to participate in the study according inclusion criteria . Participants who accepted were randomly allocated to two groups (G1 and G2) by the free randomization website. Group 1 was treated with Darifenacin, and group 2 with the PTENS protocol.

Drug Treatment Protocol:

The anticholinergic Fenazic (Adium) was used in a single dose of 15mg/day for 2 months.

PTENS Protocol:

The treatment consisted of PTENS with the Neurodyn Portable TENS FES(21) neuromuscular stimulation device in an outpatient clinic. Two self-adhesive electrodes (5x9cm) were used, positioned one in each gluteal region, below the iliac spine to apply low-frequency biphasic current with 10 Hz. Pulse duration of 0.5 milliseconds was applied for 40 minutes with continuous stimulation, 3 times a week, for 20 sessions.

Eligibility Criteria:
Inclusion Criteria:

* HTLV-1 infection
* Overactive bladder symptom
* 18 years of age or older

Exclusion Criteria:

* HTLV-1 infected subjects with HAM
* Stroke
* Parkinson
* HIV infection
* Prostatic hyperplasia
* Pacemaker use
* Genitourinary tract infection
* Glaucoma
LVHR Multicenter Study

The study aims to prove differences or equalities in outcome for patients operated with laparoscopic ventral hernia repair with different methods of fixation of mesh and with or without approximation of defect prior to meshfixation.

Patients are randomized to 4 groups: non-absorbable suture fixation and hernia approximation, double crown mesh fixation with titanium spiral tacks with hernia approximation and the same fixations without hernia approximation.

Primary endpoint is recurrence. Secondary endpoints are operating time, adhesion score, mode of entering abdominal cavity, time to recovery, pain durance, seroma formation, aesthetic result (protrusion), organ traumatization infection. Endpoints are correlated to hernia size, body mass index, previous recurrence, age, concurrent illness. Patients are followed 3 years after operation with clinical examination.

300 patients are planned included in primary study. A subgroup of organ transplanted patients is evaluated in a separate study with identical criteria for inclusion.

Eligibility Criteria:
Inclusion Criteria:

* secondary or primary ventral hernia

Exclusion Criteria:

* Loss of domain, Giant hernia with need of abdominal plastic operation, ASA score above 3
A Prospective Validation Study of Albumin Kinetics With Tracer 123 I-HSA

This is a prospective, validation study of a extempore made tracer compared with a commercial. Studies with tracer have no medical effects but are used for studying human physiology, in this case pharmacokinetic variables of endogenous albumin distribution and turnover at different levels of inflammation.

1. Primary Objective:

   - Do the extempore made tracer 123-iodine labeled albumin an commercially manufactured SERALB-125 give identical values of calculated blood plasma volume and capillary leakage measured as transcapillary escape rate of albumin?
2. Secondary Objective:

   * How do three different measures of albumin turnover correlate in volunteers?
   * How do the pharmacokinetic parameters of endogenous albumin vary between the three study groups?


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers (treatment arm I)
* on contraceptive agent and/or contraceptive device
* visual peripheral veins
* signed informed consent
* planned for elective larger interabdominal surgery (treatment arm II)
* patients with a acute pancreatitis or cholecystitis (treatment arm III)

Exclusion Criteria:

* pregnant women and/or lactating
* allergy towards excipients in 123 I HSA or 125 I HSA
* participates in another study involving radiation or stabile isotopes within a period of 60 days to study start
* it is the opinion of the principle investigator that the patient/subject should not participate for his/hers own good
Antibiotic Prophylaxis for Urinary Catheter Removal After Radical Prostatectomy

The aim of this study is to determine whether antibiotics prophylaxis at the time of urinary catheter removal decreases the number of symptomatic urinary tract infections in patients after radical prostatectomy. In addition, the investigators aim to determine whether antibiotic prophylaxis is potentially harmful to patients (e.g. adverse reactions from antibiotic use, resistant bacteria in the urine, Clostridium difficile infections etc.). The investigators also aim to identify specific populations that may be at higher risk of developing urinary tract infections with urinary catheter use after radical prostatectomy.


Eligibility Criteria:
Inclusion Criteria:

* Subjects will include patients undergoing radical prostatectomy for prostate cancer. Subjects will be randomized into control or treatment group.

Exclusion Criteria:

* Subjects with a history of adverse reaction to ciprofloxacin, or any other quinolone will be excluded. Subjects being treated with tizanidine or with a history of myasthenia gravis will be excluded. In addition, we will exclude patients with major immediate post-operative complications after prostatectomy including significant post-operative bleeding with known pelvic hematoma and known urine leak.
Fecal Microbiota Transplantation (FMT) in the Treatment of Pouchitis

The aim of our study is to investigate the efficacy and safety of fecal microbiota transplantation (FMT) in the treatment of antibiotic dependent chronic pouchitis. This is a double-blinded randomized placebo controlled study. 13 patients receive a fecal transplantation from the healthy tested donor and 13 patients in the control group receive their own feces.

Pouchitis is the most common long term complication among patients with ulcerative colitis who have undergone restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA). The etiology of pouchitis remains unclear. There is significant clinical evidence implicating bacteria in the pathogenesis. It has been shown that fecal microbiota transplantation (FMT) is an effective treatment for recurrent Clostridium difficile -infection. Case reports have also shown promising results of FMT in patients with inflammatory bowel disease. Currently there is no established effective treatment for chronic antibiotic dependent or refractory pouchitis. The aim of our study is to investigate the efficacy and safety of fecal transplantation in the treatment of chronic pouchitis instead of antibiotic therapy. Another aim is to evaluate phylogenetic analysis of the fecal microbiota trying to find microorganisms contributing to good results in fecal transplantation in IPAA patients.

Patients receive FMTs on weeks 0 and 4. Antibiotic treatment has been stopped 36 hours before the first FMT.

Eligibility Criteria:
Inclusion Criteria:

* Status post of restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) for ulcerative colitis
* Pouchitis diagnosed by the symptoms and by endoscopy including histology within 6 months prior to FMT
* Need of frequent or continuous use of antibiotics or probiotics because of the chronic pouchitis
* Availability of consecutive fecal samples during one year
* Compliance to attend FMT and control pouchoscopy after 52 weeks

Exclusion Criteria:

* Unable to provide informed consent
* Use of immunosuppressive or biological medication
* Use of corticosteroids
* Acute pouchitis
* Pregnancy
Efficacy of N-acetylcysteine to Prevent Anti-tuberculosis Drug-induced Liver Injury: A Randomized Controlled Trial

To determine the efficacy of NAC to prevent clinically significant anti-TB drugs induced liver injury (AT-DILI).

Tuberculosis is one of the most important infectious diseases and treatment related hepatitis from anti-TB drug was observed for 5-28%. Slow acetylator status in the N-acetyltransferase 2 (NAT2) genotype is a significant risk factor of anti-tuberculosis drug-induced liver injury (AT-DILI). We assessed the effect of N-acetylcysteine to prevent hepatitis from anti-TB drug in Thai population.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed TB
* Received standard dose of anti-TB drugs regimen (National Tuberculosis Control Programme guideline Thailand 2018)
* Aged ≥18 years
* Informed consent

Exclusion Criteria:

* Previous TB infection or MDR TB
* TB liver
* Allergy to NAC
* Abnormal baseline LFT
* (AST or ALT\>2.5 times UNL, ALP\> 2 times UNL, TB\> 1.5 mg/dl)
* Chronic hepatitis B, C infection
* Decompensated cirrhosis
* HIV infection
* Active malignancy
* Pregnancy or lactation
* Severe co-morbidity i.e. severe heart diseases, severe lung diseases, ESRD
Optimization of fMRI for the Study of Basal Ganglia Activation in Parkinson's Disease

Functional magnetic resonance imaging (fMRI) is a non-invasive imaging technique assessing neuronal activations during motor or cognitive tasks. The MRI sequences used are currently optimized for the study of cortex activations, particularly concerning the echo time (TE).Very few studies are interested in optimizing the fMRI for the study of the basal ganglia, structure implicated in many neurological diseases such as Parkinson's disease. The T2 \* is a tissue parameter dependent of iron content, which differs with brain structures and probably also with age and in case of neurodegenerative disease. Optimal TE s should correspond to the T2 \* of studied brain structure The primary purpose is to optimize the fMRI by a quantitative measurement of the T2\* in the cortex and the basal ganglia using MRI. The secondary purpose is to study the effect of age and Parkinson's disease on T2\*.

80 subjects (40 PD patients and 40 paired healthy volunteers (on sex and age)) aged 40-80 years will be included. PD patients will be recruited in the Department of Neurology of CHU of Clermont-Ferrand. Healthy volunteers will be selected in clinical trial database. This study will consist of one visit (at J0) during which subjects will undergo a MRI (a single acquisition of 40 minutes approximately). PD patients will be further questioned on their disease and will benefit from a neurological examination

Eligibility Criteria:
Inclusion Criteria:

* For patients :
* Patients with idiopathic Parkinson's disease according to UKPDSBB criterias
* Men or women aged between 40 to 80 years
* not treated with deep brain stimulation

For healthy subjects

- Men or women aged between 40 to 80 years

Exclusion Criteria:

For patients

* Dementia (MMS\<24)
* Contraindication to MRI.
* Under guardianship
* In excluding period for another study

For healthy subjects

* Antecedent of neurodegenerative diseases or psychiatric diseases
* Contraindication to MRI
* Under guardianship
* In excluding period for another study
Atrial Fibrillation Registry 2017

Monocentric, prospective, randomized trial of cardiac surgical arrhythmia using endocardial radiofrequency atrial ablation compared with a cryo ablation system in the setting of cardiac surgery.

Regular, rhythmic monitoring (24-hour Holter ECG, 5 and 28 days, 3 and 6 months po) of patients after cardiac surgery on the mitral valve with atrial ablation for paroxysmal, persistent, and permanent atrial fibrillation with regard to the presence or stability of sinus rhythm.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years
* Present, written informed consent from the patient
* paroxysmal, persistent, or permanent atrial fibrillation not longer than 10 years according to guidelines (ACC, AHA, ESC)
* planned cardiac surgery on the mitral valve
* ECHO parameters : LA size a.p. ≤ 55mm

Exclusion Criteria:

* permanent atrial fibrillation longer than 10 years
* ECHO parameters : LA size a.p. \> 55mm
* pregnancy
* life expectancy \< 12 months
* lack of cognitive or mental capacity to participate in the study
* Patients who are to be included in another clinical (interventional) study at the same time or who are already participating in such a study
Slow Age: Interventions to Slow Aging in Humans

The proportion of older individuals is growing, and it is therefore important to investigate ways to promote healthy aging. Exercise is one of the most studied interventions and is known to have a variety of health benefits. Dietary interventions have also shown encouraging results, with intermittent fasting being a promising anti-aging intervention. Likewise, dietary supplementation with precursors that can increase the central metabolite nicotinamide dinucleotide (NAD+) has powerful effects on aging at least in model organisms. Although physical exercise is known to increase health-span, the effects of these latter dietary interventions on aging lacks evidence in humans.

This is a randomized, controlled trial of interventions to slow aging in humans. Healthy older individuals will be randomized into either an aerobic exercise (EXE), time-restricted feeding (TRF), nicotinamide riboside (NR), or control group and followed for twelve weeks. Changes in biomarkers of aging will be assessed before and after the intervention. It is hypothesized that the interventions provide similar, superior benefits to these markers when compared to placebo.

Primary Outcome: Interleukin-6 levels. Secondary Outcomes: CRP, TNF-α, NAD+, hematologic age, epigenetic age (DNA methylation), transcriptomic age (RNA-sequencing), functional age (handgrip strength, gait speed), body composition, vocal age, and photo age


Eligibility Criteria:
Inclusion 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. Aged ≥ 65 years
4. In good general health

Exclusion Criteria:

1. Inability or unwillingness to take oral supplements
2. Inability or unwillingness to adhere to the fasting regiment
3. Inability or unwillingness to perform the prescribed physical exercise
4. Current smoker or use of any nicotine products within 10 years
5. Chronic use of supplements containing vitamin B or nicotinamide riboside
6. Treatment with another investigational drug or other intervention within 1 year
7. Cancer diagnosis within last 5 years
Evaluation of Muscle miRNA as Biomarkers in Dystrophinopathies

Duchenne muscular dystrophy (DMD) , caused by mutations in the DMD gene, is the most common and most severe progressive dystrophy of the child. Although the development is rapidly progressive , there is variability in the severity of the disease between DMD patients that do not correlate with the type of mutations in the DMD gene. There are no easily measurable biomarkers for monitoring the DMD or moderate form of the disease, Becker muscular dystrophy (BMD ) . MicroRNAs (miRNAs) are involved in most cellular processes , and their expression pattern is a signature of the state of a cell . They represent a potential class of diagnostic and prognostic biomarkers. Some are specific for the skeletal myogenesis , and changes in their pattern of expression are associated with muscle diseases including muscular dystrophy. The levels of muscle- specific miRNAs are indeed greatly increased in the serum of DMD and BMD compared to control patients .

The main objective of this is to validate the use of serum muscle-derived microRNAs as biomarkers of DMD patients (compared with healthy subjects). Secondary objectives are i) to investigate the relationship between circulating levels of these miRNAs and the severity of the dystrophinopathy (DMD vs BMD) and also the progression of the disease (longitudinal study), ii) to assess the specificity of these markers for dystrophinopathy (comparison with other patients with muscular dystrophy), iii) to test candidate miRNAs recently identified but not yet analyzed in the serum of patients.

Clinical data and samples will be recorded at each regular consultation. miRNA levels will be quantified using Real Time Quantitative RT-PCR.


Eligibility Criteria:
Inclusion Criteria:

* Patient suffers from dystrophinopathy or other muscle dystrophy,
* Healthy volunteers
* signed informed consent
* social insurance

Exclusion Criteria:

* patients or parents have not signed the informed consent,
Pharmacokinetics and Safety of Ravidasvir and Danoprevir/r in Healthy Volunteers China

The purpose of this study is to evaluate the Pharmacokinetics and safety of Ravidasvir in Combination with Ritonavir-boosted Danoprevir in Single and Multiple doses in Healthy Participants


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent
* Overall health situation is good according to disease history, physical exam, physical symptoms, laboratory tests and 12 lead ECG.
* If female, surgically sterilized or willingness to use reliable method of birth control during the study and for 30 days after the last dose of study medication.
* If male, surgically sterilized or willingness to use reliable method of birth control during the study and for 30 days after the last dose of study medication.
* If female, negative pregnancy test during the screening period.
* Others as specified in the detailed protocol

Exclusion Criteria:

* History or presence of cardiovascular disease, respiratory disease, endocrine and metabolic system disease, urinary system, digestive system, hematological system diseases, nervous system or Psychiatric diseases, and acute or chronic infectious disease and malignant tumor.
* Positive test in any of the HAV-IgM,HBsAg, HCV Ab, HIV Ab, Syphilis Ab
* History of gastrointestinal surgery, trunk vagotomy, intestinal excision or any other surgeries that could disturb gastrointestinal motility and PH absorption.
* Female during pregnancy, breastfeeding, period and unwilling to take reliable birth control method.
* Others as specified in the detailed protocol
Efficacy Evaluation of Dotarem Compared to Gadovist in the Diagnosis of Peripheral Arterial Disease

This study is an efficacy evaluation of Dotarem®-enhanced magnetic resonance angiography (MRA) compared to Gadovist®-enhanced MRA in the diagnosis of clinically significant abdominal or lower limb arterial diseases.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged ≥ 18 years.
* Patient with infrarenal aorta or chronic lower limb ischemia with various clinical signs of gravity (stages II-IV according to the classification of Leriche and Fontaine) or/and Doppler ultrasonography indicating abdominal or lower limb arteriopathy.
* Patient scheduled for a conventional X-Ray angiography (intra-arterial Digital Substraction Angiography = DSA) within 30 days of MRA with a minimum time interval of at least 24 hours between the 2 examinations.

Exclusion Criteria:

* Patient planned to undergo therapeutic intervention in abdominal or lower limb vessels between the time of MRA and X-ray Angiography will be performed.
* Patient who had a major cardiovascular event within 30 days prior to the inclusion.
* Patient treated with unilateral hip replacement, abdominal aortic or iliac graft or stent.