cyrilzakka/clinical-trials huggingface dataset:
Serotonin Effect in Functional Dyspepsia

The purpose of this study is to investigate whether Efexor (venlafaxine) is effective in the treatment of functional dyspepsia.

BACKGROUND: A good 60% of patients presenting with upper abdominal complaints have functional dyspepsia. Usually, acid-suppressive drugs are given as first-line therapy for upper gastrointestinal symptoms. However, results are often not satisfying and symptoms persist. Since many patients with functional gastrointestinal diseases are more anxious and depressed in comparison to healthy controls, several studies investigated the use of antidepressant agents in these patients. Although many studies were underpowered, promising results were obtained with tricyclic antidepressant and mianserin in patients with irritable bowel syndrome. There is still a need for a placebo controlled study with antidepressants in patients with functional dyspepsia.

OBJECTIVE: To investigate the effectiveness of venlafaxine, a selective serotonin and norepinephrine reuptake inhibitor, for treatment of patients with functional dyspepsia.

STUDY DESIGN: A randomized, double blind, placebo controlled trial.

STUDY POPULATION: Consecutive patients with persistent upper GI symptoms without abnormalities at upper gastrointestinal endoscopy.

PRIMARY ENDPOINTS: Upper gastrointestinal symptom absence after 6 weeks treatment.

SECONDARY ENDPOINTS:

* Anxiety and depression after venlafaxine treatment;
* Health related quality of life after venlafaxine treatment;
* The association between serotonin transporter protein and 5-HT receptor polymorphisms and efficacy of venlafaxine.

STUDY PROCEDURE: A venous blood sample will be collected in a 10ml EDTA-tube. Then, each subject will be randomized to treatment with Efexor XR (first and last two weeks 75 mg 1dd and from the third to the fifth week 75 mg 2dd) or identical placebos for 8 weeks. Before starting and after finishing treatment, patients will be asked to fill out a questionnaire on intensity of their gastrointestinal complaints, current quality of life and anxiety and depression.

Eligibility Criteria:
Inclusion Criteria:

* Persistent upper gastrointestinal symptoms;
* Absence of any serious organic cause of the complaints at previous upper gastrointestinal endoscopy (including gastric ulcer, carcinoma, oesophageal reflux disease, portal hypertension, hernia hiatus \>2 cm or severe gastritis);
* Over 18 years of age;
* Written informed consent.

Exclusion Criteria:

* History of bipolar disorder;
* Contra-indication for venlafaxine;
* Current or planned pregnancy or lactation;
* Diagnosed alcoholism, anorexia nervosa or bulimia;
* Current or recent (within the last two weeks) use of a selective serotonin re-uptake inhibitor (SSRI) or MAO-inhibitor;
* Any other condition or circumstance that, in the opinion of the investigator or the physician, would compromise the subject's successful participation in this trial.
Smart Kneebrace for Continuous Monitoring of Joint Angles During Rehabilitation

This study aims to investigate the effect of Smart Kneebrace use for osteoarthritis patients after total knee arhtroplasty (TKA) on post-operative performance.

This is a single-center, open-label randomized controlled clinical trail. A total of 60 participants will receive total knee arthroplasty, who will be randomly assigned into experiment or control group. Smart Kneebrace will be used for the patients during the rehabilitation for the patients in experiment group, while the patients in the control group will not receive such a smart kneebrace. Postoperative joint angles as well as visual analog scale pain score, the Western Ontario and McMaster Universities Osteoarthritis Index knee society score will be estimated before operation and at 6/12 weeks after operation.

Eligibility Criteria:
Inclusion Criteria:

* Ready to receive single-side TKA

Exclusion Criteria:

* contraindication of surgery
* self-reported diseases that cause lower limb disability (for example, cerebrovascular disease especially stroke)
Nutritional Management of Children With Chronic Diarrhea

The study objective is to assess the growth, tolerance and efficacy of a complete amino acid-based medical food in children with chronic diarrhea.


Eligibility Criteria:
Inclusion Criteria:

* Less than or equal to 9 months of age at enrollment
* Candidates for an elemental formula
* Chronic diarrhea and diagnosis of one of the following conditions: short-bowel syndrome, eosinophilic gastroenteritis, food allergy, inflammatory bowel disease, pancreatic disease, protein maldigestion, HIV-advanced disease or other underlying GI disease with chronic diarrhea controlled by a semi-elemental or elemental formula
* Parents agree to feed infant with experimental formula for least 50% of total calories during study period

Exclusion Criteria:

- Any non-approved concomitant study
Relation of Diet to Serum Homocysteine Level in Youths

To examine the relation between diet and plasma total homocysteine levels in an ethnically and geographically diverse cohort of adolescents.

BACKGROUND:

Data from observational studies suggest that plasma total homocysteine (tHcy) concentration may be an independent and modifiable risk factor for cardiovascular disease (CVD) in adults. Plasma tHcy levels respond rapidly to nutrient supplementation with folic acid and vitamins Bl2 and B6, alone or in combination. The available data and the potential for prevention provide a strong rationale for understanding determinants of tHcy in youth. However, no large U.S. studies have examined the relation between tHcy levels to individuals' dietary intakes of folic acid and vitamins Bl2 and B6 in youth.

DESIGN NARRATIVE:

During the Child and Adolescent Trial for Cardiovascular Health (CATCH) Phase 3, a cross-sectional study of serum tHcy levels was conducted in eighth grade students (Jan-June 1997). Higher mean levels of plasma total homocysteine were observed among males, Blacks, and non-users of multi-vitamins and a strong, inverse association with serum levels of folic acid and to a lesser extent, with serum vitamin Bl2. A second measurement of the cohort at grade 12 was conducted in order to assess the dose-response relation between serum tHcy and dietary intakes (not measured in grade 8) of folic acid, vitamin B12 and vitamin B6. In addition and of equal importance, changes were evaluated in serum folic acid and tHcy levels from grade 8 to 12, after full implementation of fortification of cereal and grain products in the U.S. with folic acid and its impact on the distribution of tHcy levels in adolescents described. Effective January 1, 1998, the U.S. Department of Agriculture mandated the addition of folic acid to all flour and grain products in the United States. CATCH had a unique opportunity to examine the effect of "this natural experiment" on the distribution of serum tHcy in the cohort, because serum tHcy levels were measured in grade 8, just prior to full implementation of the mandate. Furthermore, the study had adequate sample size to examine these changes among important demographic subgroups such as, males vs. females and Caucasians vs. African Americans vs. Hispanics. Information generated by this study will be valuable for designing specific dietary interventions for youth and targeting subgroups of children who may be at higher risk for CVD.

Eligibility Criteria:
The subjects for this analysis were had to be part of CATCH, a trial designed to evaluate the effectiveness of a multi-component school-based cardiovascular health promotion intervention, described elsewhere in detail(29-30). The main trial (1991-1994) was conducted among students in grades 3-5 attending 96 public elementary schools (56 intervention and 40 control schools) in California, Louisiana, Minnesota, and Texas. Following the main trial, two observational studies were conducted that measured physiologic and behavioral risk factors in study participants from grades 6 to 8 (1994-1997) (pre-fortification) and in grade 12 (post-fortification) (2000-2001).
Primary Chemotherapy by BCNU-TMZ Combination in Newly Diagnosed Anaplastic Oligodendrocytic Tumors: Phase II Trial With Translational Molecular Analysis

The first-line treatment of anaplastic oligodendrogliomas, radiotherapy exclusive or combined with PCV, will be defined by the pending results of phase III of the EORTC.

If the phase II study proposed here achieves its objective, it may help define a new treatment regimen that will be compared to the standard arm from phase III of the EORTC.

In addition, this study, by prospectively testing the predictive value of 1p and 19q deletions and of REGF amplification, may allow characterization of patients using these markers. If validated, this characterization can constitute a key element in any therapeutic evaluation (patient stratification), and potentially a major tool for medical decision support in these tumors.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven oligodendroglioma or anaplastic oligoastrocytoma, newly diagnosed, resulting or not from a low grade glioma
* Tumor with measurable contrast enhancement (at least 15 mm in diameter)
* Surgical procedure limited to a biopsy or partial excision
* In the event of partial excision, an early postoperative check-up (\<72 hours) performed at best by MRI, if not by CT, is required.
* Time between surgery and inclusion less than or equal to one and a half months (45 days)
* Age\> 18 years old; \<70
* Karnofsky index\> 60
* Stable or reduced dose of corticosteroids in the 15 days prior to inclusion
* Polynuclear neutrophils\> 1500; platelets\> 100,000
* Bilirubin \<1.25 x UNL; SGOT, SGPT, PAL \<2.5 x UNL
* Absence of serious uncontrolled pathology
* Patient having received and understood the information and having signed the consent

Exclusion Criteria:

* Presence of GBM foci within the tumor
* Absence of evaluable residue after surgery
* Previous chemotherapy or radiotherapy
* Unsatisfactory expected monitoring conditions
* Pregnant or breastfeeding woman; lack of effective contraception if of childbearing age
* History of malignant disease (with the exception of CIS of the cervix and basal cell cancer)
* Contraindications related to the examination of the I.R.M.
A Phase 3 Study of BIBP Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed

The study will evaluate the safety, immunogenicity，immune persistence and lot-to-lot consistency of Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed, (DTacP) including 2 parts:

PART 1 will evaluate the safety and immunogenicity of DTacP in health infants aged 2 months and 3 months compared with an adsorption Tetanus-diphtheria-acellular Pertussis (DTaP) Vaccine and Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine (PENTAXIM)，compare the safety and immunogenicity of DTacP with different immunization schedules, and observe the immune persistence.

PART 2 will evaluate the lot-to-lot consistency of DTacP in health infants aged 3 months with the 3-dose schedule of 3-4-5 month.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects aged 2months (60-89 days) and 3months (90-119 days) ；
* Willing to provide proof of identity
* Subjects aged 2 months have not been vaccinated with DTaP, IPV, Hib, or 13-valent pneumococcal polysaccharide conjugate vaccine;
* Subjects of 3 months have not been inoculated with DTaP vaccine, and IPV (only group A3）；
* Subjects'guardians or trustees are able to understand and sign the informed consent voluntarily, comply with the requirements of the clinical study plan.

Exclusion Criteria:

* With temperature \>37.0°C on axillary setting before vacciation;
* With a medical history of diphtheria, pertussis or tetanus;
* Had contact with individuals with confirmed pertussis, diphtheria and tetanus diseases in their families in the past 30 days;
* Premature birth (delivery before the 37th week of pregnancy)or low birth weight (birth weight\< \<2500g);
* History of dystocia, suffocation rescue, neurological damage;
* With congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
* History of epilepsy, convulsions or convulsions, or have a family history of mental illness;
* History of abnormal blood coagulation (such as coagulation factor deficiency, coagulopathy);
* Had received immune enhancement or inhibitor therapy (continuous oral or instillation for more than 14 days);
* History of severe allergic reactions to vaccination, such as difficulty breathing, urticaria;
* Any prior administration of blood products in last 3 month;
* Any prior administration of attenuated live vaccine in last 14 days;
* Any prior administration of subunit or inactivated vaccines in last 7 days;
* Plans to participate in or is participating in any other drug clinical study;
* Has any other factors judged by investigators that make them unfit to participate in the clinical trial
Evaluation of Visual Outcomes in Patients With Complex Corneas Implanted With the IC-8 IOL

The purpose of this study is to evaluate visual outcomes in patients with complex corneas who have been previously implanted with the IC-8 IOL after cataract removal.

This will be a prospective, non-randomized, single-arm, single-visit, single-center, clinical study in up to 40 patients previously contralaterally implanted with the IC-8 IOL at one clinical site in Singapore.

The purpose of this study is to to evaluate visual outcomes in patients with complex corneas who have been previously implanted with the IC-8 IOL after cataract removal. The co-primary study endpoints are monocular uncorrected distance, intermediate, near visual acuities.

Eligibility Criteria:
Inclusion Criteria:

1. Minimum 22 years of age;
2. Able to comprehend and have signed a statement of informed consent;
3. Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visit(s);
4. Having complex corneas prior to cataract surgery;
5. Previous cataract surgery and IC-8 IOL implantation in the eye (implanted for 3 months or longer prior to study participation).

Exclusion Criteria:

1. Baseline visual acuity worse than 20/25 BCDVA in either eye;
2. Presence of ocular abnormalities or conditions other than corneal irregularities that could confound the study outcome(s), such as:

   1. Strabismus or amblyopia
   2. Retinal or macular abnormalities
   3. Recurrent and/or persistent ocular inflammation
   4. Known pathology that may affect visual acuity to a level worse than 20/25 BCDVA
3. Previous intraocular surgery, except cataract surgery, pterygium surgery, or corneal procedures (other than corneal-cross linking);
4. Previous corneal cross-linking procedure with any corneal haze;
5. Conditions requiring planned ocular surgical intervention, except Nd:YAG capsulotomy;
6. Severe dry eye or other conditions (such as hormonal fluctuations) that could lead to unstable refraction and/or visual acuity measurements or eye discomfort even with ocular lubricants or dry eye medication;
7. Patient is pregnant or nursing.
Safety and Efficacy of Persistent Atrial Fibrillation Ablation With a Cryoballoon Technology

The goal of this retrospective observational study is to learn about the safety and efficacy of cryoballoon catheter ablation in 80 patients with persistent atrial fibrillation using the PolarX (Boston scientific) cryoablation technology. The main question it aims to answer is if it is safe and effective.


Eligibility Criteria:
Inclusion Criteria:

* persistent atrial fibrillation patients undergoing first atrial fibrillation ablation procedure with PolarX cryoballoon

Exclusion Criteria:

* previous atrial fibrillation ablation or cardiac surgery,
* paroxysmal atrial fibrillation,
* congenital heart disease,
* non-treated coronary artery disease,
* intracavitary thrombus,
* significant valvular disease,
* contraindications to general anesthesia.
Effect of Hypoxia on Cognitive Assessment and Cerebral Activity in Healthy Volunteers

The early assessment of new symptomatic drugs for Alzheimer disease remains difficult because of the lack of predictive end-point. The use of a battery including different parameters could improve this early development. In healthy volunteers, to test the reverse effect of symptomatic drugs, it is necessary to induce transient and reversible cognitive impairment and cerebral activity changes by a challenge test. In this context, a transient hypoxia could be relevant.


Eligibility Criteria:
Inclusion Criteria:

* Good health on the basis of the medical interview, physical examination and standard biology parameters.
* Right-Handed
* Non-smoker
* No cardiac nor pulmonary pathologies
* No use of chronic treatment or psychotropic drugs or substances
* BMI inferior to 25 Kg/m2
* French speaker and able to understand the test instructions
* Informed consent form signed

Exclusion Criteria:

1. Subject with history or current brain disease (severe brain trauma, transient ischemic attack, stroke, epilepsy, cerebral tumor...) or retinal pathologies (including familial DMLA)
2. Subject with history of Acute Mountain Sickness, High Altitude Cerebral Edema or High Altitude Pulmonary Edema
3. Subject with other major medical or surgical history including coronaropathy and pulmonary arterial hypertension
4. Subject with current chronic disease
5. Subject with vascular or metabolic risk factor
6. Subject with history of or current mental disease or addiction (MINI)
7. Subject with significant abnormality on biology
8. Subject with significant abnormality on ECG
9. Subject with significant abnormality on MRI
10. Subject with significant abnormality of electrical activities on EEG
11. Subject with family history of young onset dementia
12. Subject with family history of cardiac or pulmonary pathologies
13. Subject with family history of chronic or severe neurological or mental disease (first degree relatives)
14. Subject with claustrophobia or contraindication to MRI
15. Subject under guardianship
16. Subject not covered by Social Security
17. Subject participating in another clinical trial
18. Subject with anxiety (STAI-Trait Score T\> 51) or neuroticism personality (EPI Score N ≥13)
19. Subject bearded or refusing to shave
Use of Ulna Length to Predict Tidal Volume in Adult Egyptians

The aim of the study is to evaluate the ability of ulna length to predict accurate protective lung tidal volume in Egyptian people in reference to their standing height.

After approval of local ethical committee and informed consent, one hundred healthy volunteers will be rnrolled in this study. Height of each subject will be measured while standing upright against a wall. Then, the left ulna will be measured with a measure tape from the olecranon to mid point of styloid process. From ulna length, height is estimated as advised by Malnutrition Advisory Group, British Association of Parenteral and Enteral Nutrition. October 2008. Malnutrition Universal Screening Tool.Protective lung tidal volume is calculated as 6 ml/kg predicted body weight (PBW) as follow:

PBW= 50\*0.91 (centimetres of height - 152.4) in males and 45.5\*0.91(centimetres of height - 152.4) in females.

Each measurement will be performed only once for each subject. Agreement between measurements will be expressed by the Bland-Altman method.

Eligibility Criteria:
Inclusion Criteria:

- Healthy adult Egyptian

Exclusion Criteria:

- Deformity or previous surgery in the left arm
Selective Versus Nonselective Alpha-blockade Prior to Pheochromocytoma Resection - Systematic Review and Meta-analysis

Our aim was to systematically evaluate the current data on the efficacy of pretreatment with either selective or nonselective alpha-blockade on the hemodynamic instability and morbidity during pheochromocytoma resection.

RCTs and non-randomized controlled studies comparing preoperative selective alpha-blockade (SAB) with nonselective alpha-blockade (NAB) in pheochromocytoma surgery in adults were eligible for inclusion.

All identified articles will be screened by title and abstract. Two independent reviewers will review potentially relevant articles in detail. Dissent will be resolved by consensus and the recommendation of a third observer as required. Data from the included studies will be extracted independently by the two researchers. The Meta-analysis Of Observational Studies in Epidemiology (MOOSE) guidelines will be used for reporting.

Quality of Assessment The Risk Of Bias In Non-randomized Studies - of Interventions (ROBINS-I) tool will be used to assess the quality of included non-randomized studies. The risk of bias of randomized studies will be assessed using the criteria described in the Cochrane Handbook for Systematic Reviews of Interventions .The quality of each study will be assessed by two of the authors. In the event of uncertainties regarding the levels of the studies' quality, a third reviewer will be consulted.

Analysis will be performed using RevMan (Version 5.3, freeware from the Cochrane Collaboration). Odds ratios and their associated 95% confidence intervals will be pooled for dichotomous outcomes using the Mantel-Haenszel random-effects method. Continuous outcomes will be pooled as weighted mean difference (WMD) with 95 per cent confidence interval using the inverse-variance random-effects method. WMD and OR will be presented on the graphs as squares, and pooled WMD and OR will be presented as diamond.

P ≤ 0.05 will be considered a statistically significant difference for hypothesis and P \< 0.10 for heterogeneity testing, respectively.

Heterogeneity between the studies will be estimated by statistical tests I2 and Cochran's Q tests.

Eligibility Criteria:
Inclusion Criteria:

* All patients who received selective or nonselective alpha-blockade prior to pheochromocytoma resection

Exclusion Criteria:

* Patients who did not receive alpha blockade
* Patients not undergoing surgery
* No comparison for selective and non-selective pretreatment in the study
* Studies without primary or sufficient data (reviews, guidelines, meeting abstracts, letters),
* Studies reported in a language other than English