cyrilzakka/clinical-trials huggingface dataset:
Endoscopic Management of Fistulas Related to Sleeve Gastrectomy With Double Pigtail Stents According to the BARTOLI Technique

Obesity is a major health problem in western countries, and sleeve gastrectomy has proven its effectiveness on weight loss and improvement of comorbidities related to obesity. The main complication is the occurrence of upper fistula (2%), and may be responsible of several deaths.

There is no consensus on medical, radiological and surgical management of fistula. It depends on the resources of each center and is based on a low level evidence The inconstant efficacy of the endoscopic treatment by closing fistula (digestive stents, clips, glue) motivates a new endoscopic approach. It consists of an internal drainage of the collection by using double pigtail stents through the fistulous orifice.

Partially or fully covered stents are the most used method, but are not supported by any comparative studies. Their results are inconstant and the closure rate is estimated between 15 and 100%, with a hazardous median healing time. This method is associated with frequent complications, such as spontaneous migrations, impactions or ulcerations responsible for potentially fatal hematemesis. The preliminary results of using OTSC clips (OVESCO®) seem encouraging, but this technique requires external drainage to obtain a collection free from infection. A new approach is to perform an internal drainage of the peri-orificial collection by using double pigtail stents through the fistulous orifice and to direct the fistula closure from the outside to the inside. This endoscopic treatment, combined with nutritional support and initial antibiotic therapy, allows rapid weaning of external drainage and short healing times. CT and endoscopic evaluation are needed at the sixth week for stents removal in the event of a favorable evolution. In the opposite case, a second endoscopic treatment is performed. In case of unfavorable evolution, a radical surgical treatment, in the absence of endoscopic alternative, will be achieved.

Eligibility Criteria:
Inclusion Criteria:

* Any major patient hospitalized for a symptomatic fistula after sleeve gastrectomy, outside the exclusion criteria, is eligible.
* Free, informed and signed consent
* Affiliation to the social security system

Exclusion Criteria:

* Other surgery than Sleeve gastrectomy
* Fistula located at a site other than the upper pole of the staple line
* Fistulization on the upper diaphragmatic floor
* Fistulous orifice larger than 25 mm
* Pregnancy
* Patient under guardianship or curators or deprived of public law
Aerobic Exercise and Resistant Hypertension

This study will examine the effects of 4 months of aerobic interval training versus continuous aerobic training on ambulatory blood pressure (ABP) and novel plasma protein biomarkers in patients with resistant hypertension. A randomized controlled trial will be performed including two exercise groups and a control group: a) moderate-intensity interval training (MIIT); b) moderate-intensity continuous training (MICT); c) usual care. MIIT could represent a superior training modality that exceeds the benefits of MICT in patients with resistant hypertension.

Hypertension is associated with an increased risk of cardiovascular morbidity and mortality, and its high prevalence remains a worldwide concern. Ambulatory blood pressure monitoring (ABPM) is recognized in the diagnosis and management of hypertension, and can control blood pressure better than clinic assessment. Different studies have examined the effects of aerobic training on ABP in patients with hypertension, but the effects of moderate-intensity interval training (MIIT) and moderate-intensity continuous training (MICT) on ABP and novel plasma protein biomarkers that could potentially serve to identify cardiovascular risk, have not yet been examined in patients with resistant hypertension.To fill this gap, our aims are to determine the effects of MIIT and MICT for 4 months on ABP (primary endpoint), and on proteomic biomarkers (secondary endpoints) in patients with resistant hypertension. A total of 72 participants will be randomly divided into three groups: the first group (n=24) will perform MIIT, the second group (n=24) will perform MICT, and the third control group (n=24) will maintain usual care for 4 months. All will receive usual care for 4 months, with the structured physical exercise as the only relevant change in the intervention groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients with resistant hypertension (RH) (i.e., systolic BP/diastolic BP \>130/80 mmHg according to the American College of Cardiology/American Heart Association) despite the concurrent use of three or more antihypertensive drugs - commonly including a diuretic, a long-acting calcium channel blocker, and a blocker of the renin-angiotensin system. RH also includes patients whose BP achieves target values on ≥ 4 antihypertensive. medications (i.e., 'controlled' RH).
* Adherence to prescribed medications.
* Willing to be randomized to one of the 3 groups.
* Informed consent.

Exclusion Criteria:

* Exclusion criteria will include exercising more than 30 minutes on 3 days or more weekly.
* Severe ischemic heart disease, major psychiatric disorder and other health contraindications that may interfere in the evaluations or interventions.
Oil-based Vs. Water-based Contrast Medium in Hysterosalpingography for Infertile Women in Improving Fertility Outcome

The goal of this clinical trial is to compare the effects of oil-based contrast medium (OBCM) and water-based contrast medium (WBCM) during hysterosalpingography（HSG）on pregnancy outcomes in infertile women. The main question it aims to answer is whether an oil-based contrast medium improves fertility outcomes in infertile women. Participants were divided into those who received an oil-based contrast medium (ethiodized poppyseed oil) and a water-based contrast medium (Ioversol) based on a shared medical decision-making process between patients and healthcare providers. The two contrast agents used in this study are routinely employed in clinical practice and will not affect the participants\&#39; health. Participants are required to complete some clinical questionnaires before and after the HSG procedure to provide clinical information. Other than that, there will be no additional costs for participants.


Eligibility Criteria:
Inclusion Criteria:

1. age ≥18 years
2. infertility for at least one year without the use of contraceptives.

Exclusion Criteria:

1. endocrine disorders, including Cushing's syndrome, hypothalamic amenorrhea, adrenal hyperplasia, diabetes, or thyroid dysfunction (except for well-controlled hypothyroidism with a TSH level between 0.3 and 4.0 mIU/L)
2. known allergy to contrast agents, specifically iodine
3. male partner infertility, defined as post-wash sperm motility \&lt;3 million/mL or \&lt;1 million/mL without sperm washing
4. contraindications for undergoing HSG
5. refusal to provide informed consent.
Effects of Resveratrol in Patients With Type 2 Diabetes

Animal studies indicate that resveratrol, a phytoalexin enriched in the skin of red grapes and a constituent of red wine, is associated with longevity likely through the increased production of a protein, SIRT1.

The trial is a proof-of-concept study primarily designed to examine for the first time in humans, the effect of 12 weeks of oral resveratrol on skeletal muscle SIRT1 expression in 10 patients with T2DM in a randomized, placebo-controlled, double-blind fashion. Secondary outcomes include measures of AMPK, p-AMPK and GLUT4 expression levels, energy expenditure, physical activity levels, distribution of abdominal adipose tissue and skeletal muscle fiber type composition, body weight, HbA1c, plasma lipid subfraction, adiponectin levels and insulin sensitivity.

Eligible criteria include Chinese males, aged between 40 and 69 years old, with T2DM with a HbA1c of 7.1 to 12% and who have been on a stable oral hypoglycemic regimen for the past 3 months. Subjects who were insulin-dependent, with renal or liver impairment or who were terminally ill were excluded.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to give informed consent
2. Chinese Male
3. Age 40 to 69 yrs old
4. For subjects with type 2 diabetes mellitus

   * Diagnosis of type 2 diabetes mellitus based on MOH criteria and,
   * HbA1c \>6.5 during screening

Exclusion Criteria:

Willing to abstain from ingesting large quantities of resveratrol-containing foods (eg. red wine, nuts) Cancer diagnosis that is currently under treatment, is clinically detectable, or that has been treated within the past 5 years Terminal disease or on palliative care Current excessive alcohol intake (\>21 units per week for men; 14 units per week for women) On maximal doses of 3 or \> oral hypoglycaemic agents On insulin therapy or known type 1 diabetes mellitus Past history of documented or suspected hypoglycemia within last 3 months Past history of recurrent hypoglycemia Past history of serious hypoglycemia as defined by documented hypoglycemia requiring hospital admission Past history of hyperglycemic emergencies within last 6 months Past or current history of hemorrhagic strokes On anti-platelet agents, non-steroidal anti-inflammatory drugs (NSAIDs), anti-coagulation therapy or omega-3 fatty acids History of unexplained bleeding disorders History of any grape allergy History of allergy to local anaesthetic History of surgery with surgery with clips, staples or stents Presence of cardiac pacemaker or metallic foreign body in any part of the body On alternative or traditional medications Treated with another investigational drug within last 6 months Poorly controlled hypertension (SBP \>/= 160 or DBP \>/= 100) within last one month ALT and/or AST \> 1.5 times above upper limit of normal within last 6 months GFR \< 50 ml/min/1.73m2 (MDRD equation) within last 6 months
Efficacy Evaluation of Traditional Chinese Medicine JITAI Combined Comprehensive Model Among Heroin Addicts After Detoxification

The purpose of this research is to observe the efficacy of comprehensive treatment model to improve treatment compliance and relapse prevention.

The model include the Chinese traditional medicine JITAI combined with psychological intervention and social support for maintenance therapy after acute detoxification of heroin addicts.On the basis of the existing community management experience and community of professional anti-drug community service，The investigator will adopt the Chinese traditional medicine JITAI combined with psychological intervention and social support for maintenance therapy after acute detoxification of the community of heroin addicts.The purpose is to observe the comprehensive treatment model to improve treatment compliance and relapse prevention，then the investigator will form a new model of community humane drug treatment.

Eligibility Criteria:
Inclusion Criteria:

* Clinical Diagnosis of The opioid dependence
* After detoxification.

Exclusion Criteria：

* Clinical Diagnosis of glaucoma and other severe mental disorder；
* serious organic disease within three months；
* can not comply with the test requirements；
* accept Hans therapy instrument；
* have tendence of suicide，self-injury and impulse；
* ECG abnormalities；
* ALT or AST greater than 5 times the upper limit of normal；
* history of epilepsy；
* Lactating or pregnant women，or women of childbearing age fails to take effective contraceptive measures；
* serious history of drug allergy or known allergy on traditional Chinese medicine JITAI；
* Study before the withdrawal less than a half-life of 5.
The Use of a Pacifier to Correct Malocclusions in Young Children

The aim of the study is to investigate the effect of a pacifier (102 Medical Pacifier, Curaprox, Switzerland) on malocclusions like posterior crossbite, anterior open bite, larger overjet and tongue dysfunction in young children.


Eligibility Criteria:
Inclusion Criteria:

* Children who are sucking the pacifier and / or baby bottle for the last 6 months in use.
* Manifesting posterior crossbite in which minium 1 tooth and/or edge to edge in the region deciduous canines and/or deciduous molars, with or without forced bite.

AND / OR

- Manifesting anterior open bite in which the overbite has negative values or edge to edge (≤ 0), with or without tongue thrust.

Exclusion Criteria:

* Children who are thumb- or fingersucking (or sucking other objects)
* syndromic or cleft patients
* patients with history of cranio-facial trauma, history of temporomandibular joint infection or musculo-skeletal asymmetry (e.g. scoliosis, torticollis)
* patients with systematic diseases
* patients currently under or after orthodontic Treatment
* patients with ankylosed teeth (e.g. after dental trauma).
Bioavailability of Vitamin D in Cod Liver Oil and Multivitamin Tablets in Healthy Subjects in Norway

The main aim of the present study is to compare the bioavailability of vitamin D from cod liver oil and multivitamin tablets given to healthy individuals under the same conditions, as well as to study the influence of gender and ethnicity on vitamin D absorption. Healthy subjects will be randomised into two parallel groups receiving 10 micrograms (400 IU) per day of vitamin D3 from one fish oil capsule or one solid multivitamin tablet, respectively. Serum samples will be drawn at baseline and after four weeks (28 days) for the analysis of 25-hydroxyvitamin D, 1,25-dihydroxyvitamin D, parathyroid hormone, and tartrate resistant acid phosphatase in serum.


Eligibility Criteria:
Inclusion Criteria:

* Must be able to meet at baseline and follow-up visit

Exclusion Criteria:

* Using any vitamin D containing supplements regularly (\> once per week)
* Travelled to sunny countries in the previous 3 months
* Used a tanning bed in the previous 3 months
Lung Volume Perception and Impact of a Cognitive Task on Ventilation in Hypermobile Ehlers-Danlos Syndrome.

Patients with hypermobile Ehlers-Danlos syndrome have respiratory and proprioceptive disorders. The aim of this study is to explore whether there is an alteration in lung volume perception in patients with hEDS compared to healthy subjects, and whether a cognitive task can influence ventilation control differently in subjects with hEDS than in healthy subjects.


Eligibility Criteria:
Inclusion Criteria (common):

* More than 18 years old
* Understanding French

Inclusion Criteria (hEDS Patients):

* hEDS diagnosis

Inclusion Criteria (healthy subjects):

* Age (±5 years), Gender and BMI (±2.5kg/m²) matching

Exclusion Criteria (common):

* Pregnancy

Exclusion Criteria (hEDS Patients):

* Respiratory comorbidity independent of hEDS
* Previous participation in a rehabilitation programme at the clinic

Exclusion Criteria (healthy subjects):

* Known respiratory or proprioceptive pathology
* Hypermobility (evaluated with the Beighton score)
Evaluation of Safety and Activity of Celaderm in Healing Venous Leg Ulcers

This pilot study was designed to test the safety of Celaderm(TM) in treating venous leg ulcers and to give preliminary information about the efficacy of two different Celaderm(TM) dosing regimens.

Celaderm(TM) weekly for four weeks or biweekly for four treatments combined with Profore(R) compression vs. Profore(R) compression alone.

Eligibility Criteria:
Inclusion Criteria:

* venous ulcer \> 1 month and \< 12 months in duration; 2 to 20 sq cm in surface area; not infected
* confirmatory venous ultrasound showing prior DVT and concurrent venous reflux
* ankle-brachial index 0.80 or greater

Exclusion Criteria:

* cutaneous malignancy
* recent treatment with corticosteroids or chemotherapeutic agents
* wound exposed bone, tendon or neurovascular structure
* wound infected and requiring antibiotics
Effects of Lanthanum Carbonate on FGF-23 in Subjects With Stage 3 CKD

To assess the effects of 12 weeks of treatment with lanthanum carbonate compared with placebo on serum intact Fibroblast Growth Factor 23 (FGF23) levels.


Eligibility Criteria:
Inclusion Criteria:

Subjects meeting all of the criteria listed below may be included in the study:

1. ≥18 years old.
2. Male, or non-pregnant, non-lactating females who agree to comply with any applicable contraceptive requirements of the protocol.
3. Been in the care of a physician for CKD for \>2 months, and are not expected to begin dialysis for at least 6 months.
4. Screening serum c-terminal FGF23 \> 50.0RU/mL.
5. Screening estimated glomerular filtration rate (eGFR) of 30-59mL/min/1.73m2 using the MDRD formula.
6. Normal serum phosphate (0.808-1.55mmol/L).
7. Endogenous 25-hydroxy Vitamin D levels \>20ng/mL.
8. Adequate protein diet (includes 2-3 portions of protein-rich food per day).
9. An understanding, ability, and willingness to fully comply with study procedures and restrictions.
10. Ability to provide written, signed, and dated (personally) informed consent to participate in the study.

Exclusion Criteria

1. Vitamin D supplementation required.
2. Compounds containing calcium, phosphate, aluminium or magnesium required.
3. Acute renal failure.
4. Rapidly progressing glomerulonephritis.
5. Vegetarian diet.
6. Known allergy to iodine.
7. Clinically significant uncontrolled concurrent illness, which, in the opinion of the Investigator, would impair subjects' ability to give informed consent or take part in or complete this clinical study.
8. Cirrhosis or other clinically significant liver disease (aspartate transaminase (AST) or alanine transaminase (ALT) \>3 times the upper limit of normal or bilirubin \>2 times the upper limit of normal).
9. Past (treated within the last 5 years) or present GI disorders including uncontrolled peptic ulcer, Crohn's disease (or other conditions where the integrity of the GI tract may be compromised), malignancy, or GI bleed within the last 6 months.
10. Life-threatening malignancy or current multiple myeloma.
11. Known to be Human Immunodeficiency Virus (HIV) positive.
12. History of poor compliance with diet or medication that in the Investigator's opinion may interfere with adherence to the protocol.
13. History of alcohol or other substance abuse within 6 months prior to screening.
14. Subjects must not have used another investigational medicinal product or taken part in a clinical trial within the last 30 days prior to enrolment.
15. Subjects who have previously been enrolled into this study and subsequently withdrawn.
Effects of tDCS-enhanced Cognitive Control Training on Depression

Deficient cognitive control (CC) is one of the central characteristics of major depression (MD). Hypoactivation of the dorsolateral prefrontal cortex (dlPFC) has been linked with this deficit. Antidepressants and cognitive-behavioral therapies modify CC most-likely as a common mechanism of treatment. Transcranial direct current stimulation (tDCS) is a safe, simple and effective non-invasive method to modulate the cortical excitability. It has been shown, that the activity of the dlPFC can be modulated by transcranial direct current stimulation (tDCS) with polarity-dependent learning-phase specific effects on performance that, when combined with training, can outlast the stimulation.

The goal of this randomized, sham-controlled, rater blind clinical trial is to investigate the effect of a tDCS-enhanced CC Training (CCT) on depressive symptom severity and compare the stimulation intensities 1mA, 2mA and sham tDCS. Overall, the study will include 57 participants (n = 19 per group). Each participant will complete 12 training sessions with online sham/ anodal tDCS.

As a training task we will use an adaptive version of the paced auditory serial addition task (PASAT). In the PASAT, digits are presented auditive and participants have to add the current digit to the digit they heard before. In the adaptive version the interstimulus-intervals decrease (increase) when four consecutive trials are correct (incorrect). The PASAT is known to elicit frustration. Participants have to exert cognitive control over these emotions to complete the task successfully.

Before, during and after the training symptom severity will be assessed. Baseline and post-training performance in the PASAT and in a transfer task (delayed working memory task, DWM) will be measured.

To further explore variables that influence the effect of tDCS on depressive symptom severity we will measure brain activity (EEG, NIRS), heart rate, global functioning (GAF), emotion regulation strategies, self-esteem, mood ratings and subjective performance ratings before and after the training and collect genetic factors.

Sustainability of the training effects will be measured at a follow-up visit (3 months later).


Eligibility Criteria:
Inclusion Criteria:

* current Major Depressive Episode
* right handedness

Exclusion Criteria:

* history of seizures
* Intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed
* pregnancy
* use of mood stabilizers
* diagnosed bipolar disorder
* current substance abuse (nicotine excluded)
* current substance addiction (nicotine excluded)
* diagnosed psychotic diseases
* diagnosed anorexia nervosa
* diagnosed personality disorders: cluster A, antisocial personality disorder,
* borderline personality disorder
Evaluation of the Onset and Duration of Action of Bepotastine Besilate Ophthalmic Solution in Acute Allergic Conjunctivitis

The purpose of this study is to evaluate whether bepotastine besilate ophthalmic solution is effective in the treatment of acute allergic conjunctivitis


Eligibility Criteria:
Inclusion Criteria:

* At least 10 years of age \& either sex, any race
* Willing and able to follow all instructions and attend all study visits
* Positive history of ocular allergies

Exclusion Criteria:

* Have planned surgery during trial period
* Female currently pregnant, planning a pregnancy, or lactating
Nitrates and IL-8 in Barrett's Esophagus

The purpose of this study is to determine if nitrates and IL-8 (which are found in food and throughout the body regulating stomach acidity) play a role in Barrett's Esophagus and/or Esophageal Adenocarcinoma severity and if screening for these biomarkers can help predict patients that are more at risk for developing worsening disease.


Eligibility Criteria:
Inclusion Criteria:

- Patients undergoing a clinicallly-indicated Esophagogastroduoedoscopy (EGD).

Exclusion Criteria:

* Comorbid inflammatory medical condition.
* Use of antiinflammatory (aspirin and NSAIDs) or immunosuppressants over the past 1 week.
* Use of nitrate containing medication in the past 1 week.
* Consumption of nitrate rich foods in preceding 24 hours.
* Known allergy to meat or nitrates
High Intensity Training to Reduce the Risk of Falls in Older People

Due to the high incidence of falls in the elderly population, this study is presented as a method to reduce the risk of falls through a specific type of training in people over 60 years of age.

A 16-week high intensity interval training (HIIT) program, compared to a continuous exercise program and one that does not perform any training program, decreases the risk of falls and improves the state of health, physical condition and quality of life to a greater extent than a group that does not perform any type of exercise in people over 60 years.

Eligibility Criteria:
Inclusion Criteria:

* To participate in the study, participants will be required to be 60 years of age or older.

Exclusion Criteria:

* All participants with diseases that may alter balance and functional activity (such as auditory or vestibular alterations), central or peripheral neurological disorders, other rheumatological diseases, or serious psychiatric or somatic diseases will be excluded.