cyrilzakka/clinical-trials huggingface dataset:
Effect of Homocysteine-lowering Therapy With Folic Acid, Vitamin B12, and Vitamin B6 on Endothelium-dependent Vasodilatation of Forearm Resistance Vessels in Patients With Coronary Heart Disease

Endothelial dysfunction is an early marker of atherosclerosis and is found in patients (pts) with coronary (CAD) and peripheral artery disease (PAD). Statin-therapy has been shown to improve endothelial function in pts with CAD or PAD by reducing LDL-cholesterol and inflammatory markers. B-group vitamin-supplements have variable been reported to have positive or neutral effects on endothelial function. Therefore, we want to compare the effect of rosuvastatin and B-group vitamin supplementation on endothelial function of the forearm resistance vessels in pts with cardiovascular disease.

Study design: 36 pts with CAD or PAD are randomly assigned to either rosuvastatin 10mg/d or vitamin supplementation with folic acid 1mg, vitamin B12 0.4mg and B6 10mg/d for 6 weeks in a double-blinded design. After 6 weeks all pts receive rosuvastatin and vitamin supplementation in combination for additional 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* CAD or PAD (\>50% luminal stenosis), previous myocardial infarction or bypass surgery \>3 month ago
* history of percutaneous coronary intervention (PTCA or stenting)
* confirmed consent

Exclusion Criteria:

* myocardial infarction or acute coronary syndrome or bypass surgery \<3 month ago
* ongoing treatment with statins
* ongoing vitamin supplementation with folic acid and B vitamins
* \<18 years
* active smokers
* uncontrolled arterial hypertension
* renal insufficiency
* atrial fibrillation
* liver disease
* NYHA class \>2
* familial hypercholesterolemia
Benefit of Pharyngeal and Oesophageal pH-impedance of Patients With High Suspicion of Laryngopharyngeal Reflux

Laryngopharyngeal reflux (LPR) is the retrograde movement of gastric contents into the larynx, pharynx and upper aerodigestive tract. The symptoms and manifestations are very changeable and non specific. Pharyngeal and Oesophageal pH-impedance may help to detect these reflux and to identify patients with abnormal LPR.

To compare and describe the results of pharyngeal and oesophageal pH-impedance of patients with high suspicion of laryngopharyngeal reflux, with the results of healthy patients.

This is a monocentric, prospective descriptive study. Patients will be recruited in otolaryngology and gastroenterology departments of Bordeaux teaching hospital. A first clinical, endoscopic and pH-impedance evaluation will be made, after at least 15 days of interruption of any proton pump inhibitors (PPI). After 8 weeks' treatment by double PPI doses (esomeprazole 40 mg bid), another clinical and pH-impedance evaluation will be realized. The characteristics of the patients who respond to the treatment will be compared to non responders. The subjects will also have an initial laryngoscopy, an oesophageal manometry allowing the location of the lower sphincter of the oesophagus and the upper sphincter of the oesophagus for positioning the catheters.

Eligibility Criteria:
Inclusion Criteria:

* age : 18 to 80 years old.
* Written consent
* Laryngopharyngeal symptoms (dysphonia, and/or globus and/or sensation, and/or pharyngeal pain, and/or cough) for 3 months at least.
* No PPI for at least 15 days
* Social security affiliation

Exclusion Criteria:

* Sinusitis or chronic rhinitis (in the previous year)
* Laryngeal trauma, tracheotomy or pharyngolaryngeal surgery
* pregnancy or absence of efficacy contraception
* breast feeding
* history of gastrointestinal pathology, diabetes, neurological condition
* cardio-vascular history requiring the taking of Plavix
* esomeprazole contraindication or intolerance
Acupuncture for Polycystic Ovarian Syndrome

This is a randomized control trial of acupuncture for women with polycystic ovary syndrome. The study is triple-blinded.


Eligibility Criteria:
Inclusion Criteria:

* ages 18-43
* confirmation of PCOS through the study
* signed informed consent
* able to receive study treatment at Virginia study sites
* agree not to use hormonal medications for the 5 months of the study

Exclusion Criteria:

* pregnant
* use of hormonal drugs 30/60 days before the study entry
* acupuncture for ovulatory disorders 30 days prior to study entry
Comprehensive Yoga Therapy Based Lifestyle Prehabilitation Program for Women With Ovarian Cancer

To provide a comprehensive yoga therapy (CYT) program to patients with ovarian, fallopian tube, or primary peritoneal cancer who are scheduled to receive chemotherapy and then undergo surgery. Researchers want to learn about the effects of the program on patients' quality of life and other outcomes described below.

Primary Objectives:

To assess the feasibility of a CYT prehabilitation program in women with ovarian cancer scheduled to receive NACT and IDS. Feasibility criteria will include consent (30% of those approached) and study retention (60%) rates.

Secondary Objectives:

Examine the effects of the CYT program on physical conditioning as assessed by the 6 min walk test (6MWT) and sit to stand reps (30secSTS) compared with WLC.

Examine group differences in surgical outcomes including post op stay, readmission rate, post op morbidity, surgical site infection rate, transfusions, and time to first chemotherapy post operatively.

Examine group differences in patient-reported outcomes including QOL, fatigue, stress, sleep disturbances, mental health, social support, and mindfulness.

Examine if there are group differences in preoperative albumin level, vit D, magnesium levels.

Examine group differences and changes over time in microbiome biodiversity.

Examine group differences in body composition (sarcopenia) as measured by routine abdominal CT scans.

Explore the association between adherence to the components of CYT with ability to sustain behavior changes and between changes in lifestyle parameters with outcomes. This will be explored both within and across groups.

Eligibility Criteria:
Inclusion Criteria:

1. Women with stage III-IV epithelial ovarian, fallopian tube, primary peritonal cancer with recommendations for NACT/IDS at recruitment.
2. Able to read, write, and speak English.
3. 18 years of age or older.
4. Oriented to person, place, and time.
5. Access to internet connection.
6. Access to a tablet, laptop or computer or smart phone.
7. Plan for surgical intervention at MD Anderson Cancer Center
8. Performance status 0-2.

Exclusion Criteria:

1. Have completed chemotherapy.
2. Any major thought disorder (e.g., schizophrenia, dementia).
3. Any major communication barriers that would preclude being able to complete the intervention (e.g., visually or hearing impaired).
4. Extreme mobility issues (e.g., unable to get in and out of a chair unassisted).
Retention Rates of Adalimumab, Etanercept and Infliximab as First and Second-Line Biotherapy in Patients With Rheumatoid Arthritis in Daily Practice

To compare retention rates of adalimumab, etanercept and infliximab as first-line biotherapy in rheumatoid arthritis (RA), to determine causes of discontinuation, retention-associated factors, and retention rates of possible second-line tumor necrosis factor α inhibitors (TNFi).

In this retrolective, multicentric study, medical charts of RA patients starting TNFi between March 2005 and April 2009 were reviewed, with follow-up between 2 and 6 years. The retention rate was estimated using the Kaplan-Meier method. Comparison between TNFi was done after adjustment using a Cox model. Factors associated with better retention were identified by multivariate analysis. Medical charts of all patients with RA starting a first TNFα inhibitor therapy between March 1, 2005 (start of commercialization of adalimumab in France) and April 30, 2009 (allowing at least 2 years of follow-up) were systematically reviewed in detail by 2 rheumatologist investigators

Eligibility Criteria:
Inclusion Criteria:

* RA defined by the 1987 ACR criteria \[18\]
* first TNFα inhibitor prescribed in the previously mentioned period
* TNFα inhibitor prescribed as first-line biotherapy
* undergone at least one evaluation in the center after treatment initiation

Exclusion Criteria:

* previously received another biotherapy
* TNFα inhibitor was prescribed in an RCT
* refused to participate
Effect of LED Therapy for Treatment Nipple Fissure

Treatment options for nipple fissures include drug therapy with antifungal and antibiotics, topical applications of lanolin, glycerin gel, creams and lotions, the milk itself, hot compresses and silicone nipple shields. Studies involving a light-emitting diode (LED) therapy have demonstrated anti-inflammatory properties, the enhancement of the wound repair process and the control of pain.

Nipple fissures are the second major cause of the discontinuation of breastfeeding, following a sensation of insufficient milk, which leads to bottle feeding. Poor positioning of the child in relation to the breast, an inadequate frequency or duration of breastfeeding and improper suckling are the main causes of nipple fissure. Discontinuing breastfeeding deprives the infant of essential nutrients and also deprives the mother of certain health benefits. Treatment options for nipple fissures include drug therapy with antifungal and antibiotics, topical applications of lanolin, glycerin gel, creams and lotions, the milk itself, hot compresses and silicone nipple shields. Studies involving a light-emitting diode (LED) therapy have demonstrated anti-inflammatory properties, the enhancement of the wound repair process and the control of pain. As it does not cause discomfort, is relatively inexpensive and may impede the discontinuation of breastfeeding, phototherapy could be a viable option for the treatment of nipple fissures.

The aim of this study is to evaluate LED therapy in treatment of nipple fissures

Eligibility Criteria:
Inclusion Criteria:

1. Nursing mothers aged 18 years or older
2. Diagnosis of nipple fissure and nipple pain with a minimum score of 1 on the Store and Champion scales
3. Having given birth to a healthy, full-term child
4. Performing exclusive breastfeeding
5. Newborn with no oral, palatal or maxillofacial abnormalities
6. Newborn weighing between 2500 and 4000 grams

Exclusion Criteria:

1. History of psychological disorder
2. Presence of mastitis
3. Bacterial or fungal infection in breasts
4. Use of breast pump or plastic nipple
Oxypurinol Compared With Placebo for Class III-IV NYHA Congestive Heart Failure

The OPT-CHF (OxyPurinol Therapy for CHF) study is designed to demonstrate the efficacy and safety of oral oxypurinol vs. placebo in a randomized, double-blind, twenty-four week trial in 400 patients in up to 50 centers. Measures of clinical efficacy (NYHA class and Patient Global Assessment) as well as clinical outcomes (e.g., death, worsening heart failure, and hospitalization) will be assessed as a composite endpoint in this trial.


Eligibility Criteria:
Inclusion criteria

* 18-85 years old,
* Stable NYHA Class III-IV
* Hospitalization or ER visits in past 18 months for worsening Heart Failure (or addition of new heart failure medication added to regimen due to lack of stability on current regimen.
* EF =\< 40%

Exclusion criteria

* Any condition (other than CHF) that could limit exercise
* Any concurrent disease likely to limit life expectancy.
* Participation in another clinical trial
* Primary valvular disease, active myocarditis, or an obstructive or restrictive cardio-myopathy
* Heart Attack, Stroke, Unstable Angina or Cardiac surgery within previous 3 months
Myeloproliferative Neoplastic Diseases Observatory From Brest

All patients diagnosed or followed in Brest University Hospital for Philadelphia negative myeloproliferative neoplasms will be included in this observational study.

Myeloproliferative neoplasms recorded included: polycythemia vera, essential Thrombocythemia and Primary Myelofibrosis.

This is a not interventional study. Alive patients need to sign a non-opposition consent form.

Patients will be followed until last news (death, change of reference centre...).

In this retrospective and prospective study, clinical and biological data from diagnosis until last news will be recorded.

Clinical data collected: patients and disease characteristics at the time of the diagnosis, disease and mutational status, cardio-vascular risk factors, history of thrombosis and cancer.

Biological data collected: hemogram and bone marrow results if available. During the follow-up new data will be noted: treatment changes (reasons of change and type of drug), thrombotic events (localization, date and hemogram), phenotypic evolutions (type and date), death (date and etiology).

Eligibility Criteria:
Inclusion Criteria:

* Patients with essentiel thrombocythemia, polycythemia vera or primary myelofibrosis
* Signature of the non-opposition consent form

Exclusion Criteria:

* None
Movement-based Infant Intervention

The objective is to pilot test the effectiveness of an evidence-based intervention to promote positive neurodevelopmental outcomes in infants at risk for developmental delay. The intervention promotes movement experience from 3 months to sitting onset.

Aim: Our purpose was to assess daily leg movement rate before and after a caregiver-provided in-home intervention for infants at risk for developmental disability. We also assessed adherence and quality of caregiver-child interaction.

Methods: Twelve infants, at risk for developmental disabilities, and their caregivers participated in an intervention focused on increasing leg movements. Intervention started between 3- and 6-months cor- rected age and ended once the infant was able to sit independently or at 9 months corrected age, whichever occurred first. Infants were assessed monthly.

Eligibility Criteria:
Inclusion Criteria:

* Infants will be 3 months of adjusted age at the first visit, +/- 10 days. Infants will be defined as at risk if they qualify for high risk infant follow up care as defined by California Children's Services.

Exclusion Criteria:

* Infants with congenital malformations of the legs will be excluded.
Trial of PED-1 in Male Patients With Premature Ejaculation

The purpose of this study is to evaluate whether PED-1 is more effective than Placebo in the treatment of premature ejaculation.

This study is to evaluate whether PED-1 is effective than Placebo in the treatment of premature ejaculation. The patients will be randomized and allocated to two treatment groups into placebo, PED-1. The criteria for Intravaginal Ejaculation Latency Time(IELT) for enrollment will be \> or =2 min in the at least 75% of the sexual intercourse. To diagnosis premature ejaculation, the PEDT(Premature Ejaculation Diagnosis Tool) will be used. The patients undergone drug free baseline period will take test drugs for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent for subjects and partners
* Men 20-65 ages
* Stable monogamous relation at least for 6 mo
* Premature Ejaculation Diagnosis Tool (PEDT) more than 9
* At least 6 mo of premature ejaculation Hx
* IELT of =\< 2 min in \>= 75% of evaluable events during 4 week screening period

Exclusion Criteria:

* History of medical or psychiatric illness
* Erectile dysfunction (\<21 International Index of Erectile Function-Erectile Function (IIEF-EF) domain score) or other forms of sexual dysfunction
* Partner sexual dysfunction
* Known hypersensitivity to clomipramine and contraindications for clomipramine
Anterior Temporal Epilepsy Neuropsychological Assessment of Faces

The purpose is to evaluate neuropsychological effects of anterior temporal epilepsy in face perception by comparison of performances of epileptic patients and control individuals, sex-, age- and socio-educational level-matched.

Secondary purposes are to prospectively evaluate neuropsychological impact of anterior temporal lobectomy performed for surgical treatment of anterior temporal epilepsy on face perception (exploratory study).


Eligibility Criteria:
Inclusion Criteria:

ALL:

* Informed consent
* Affiliation to social security
* Preliminary medical examination

PATIENTS WITH EPILEPSY:

* Symptomatic drug-resistant anterior temporal epilepsy (confirmed with video-electroencephalography and magnetic resonance imaging and if necessary intracerebral SEEG exploration)
* Patient needing anterior temporal lobectomy and undergoing pre-surgery conventional intercritical assessment for surgery decision
* Nonverbal IQ ≥ 70 (WAIS-IV)
* At least 6 successful VOSP tests (perception test)

Exclusion Criteria:

ALL:

* persons under legal protection or incapable to consent
* Persons deprived of liberty by juridical or administrative decision

PATIENTS WITH EPILEPSY:

- Sever visual disorders of neurological or ophthalmological origin

CONTROL INDIVIDUALS:

* Psychiatric or neurological disorders
* Important ophthalmological disorders
The Effect of Baby Care Training Given to Fathers After Birth

The aim of this study is to provide infant care training to fathers and to measure father-infant attachment and maternal postpartum depression and quality of life.

Objective: The aim of this study is to provide infant care training to fathers and to measure father-infant attachment and maternal postpartum depression and quality of life.

Design: The data for the study were collected using the introductory information form (IIF) and the father-infant attachment scale (FIAS) for fathers, Edinburgh Postpartum Depression Scale and Postpartum Quality of Life Scale for mothers.

Participants and setting: A total of 64 fathers and 64 mothers, including 32 in the intervention group and 32in the control group who met the inclusion criteria of the study were included randomly.

Eligibility Criteria:
Inclusion Criteria:

* The mother and father are over 18 years old,
* Parents becoming parents for the first time,
* The newborn is healthy, born at term, with the mother and father,
* Parents' knowledge of Turkish,
* Mothers who accepted to participate in the study and received baby care training by participating in the pregnant class,
* Parents' willingness to participate in the research.

Exclusion Criteria:

* Having a baby born as a result of a risky pregnancy,
* The newborn is in intensive care,
* Presence of diagnosed psychiatric disease in the mother and father.
A Study of CS1003 in Subjects With Advanced Solid Tumors

This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment effect of a new drug known as CS1003 in patients with advanced tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumor and have progressed, are intolerant to, refuse to accept or do not have access to standard therapy.
2. ECOG performance status of 0 or 1.
3. Subjects with evaluable but non-measurable lesion are eligible for Phase Ia. Subjects must have at least one measurable lesion per RECIST Version 1.1 to be eligible for Phase Ib.
4. Archived tumor tissue samples need to be collected, or subjects consent to undergo pre-treatment biopsy if archived sample is not available.
5. Life expectancy ≥ 3 months.
6. Subject must have adequate organ function.
7. Use of effective contraception (males and females).

Exclusion Criteria:

1. Subjects with known symptomatic or untreated brain metastasis or other CNS metastasis.
2. Subjects with active autoimmune diseases or history of autoimmune diseases.
3. Subjects who have to receive glucocorticoids (prednisone at \> 10 mg/day or equivalent) or other immunosuppression within 14 days prior to the first dose of CS1003.
4. Subjects with other malignant tumor(s) in the past 2 years are not eligible for Phase Ib, except for those with basal cell carcinoma, in situ breast cancer and cervical carcinoma in situ who have undergone radical treatment.
5. Subjects who have received any immune checkpoint treatment, including PD-1, PD-L1, etc.
6. Receipt of chemotherapy, targeted therapy, or any other anti-cancer systemic treatment within 2 weeks prior to the first dose of CS1003.
7. Receipt of major surgical procedure or wide field of radiation within 28 days prior to the first dose of CS1003, local radiotherapy within 14 days prior to the first dose of CS1003, or radioactive agents within 56 days before the first dose of CS1003.
8. Receipt of Chinese herbal medicine or Chinese prepared medicine within 7 days prior to the first dose of CS1003.
9. Receipt of live vaccine within 28 days prior to the first dose of CS1003.
10. History of interstitial lung disease or non-infectious pneumonitis, except for those induced by radiation therapies.
11. History of HIV infection.
12. Subjects with active Hepatitis B and C infection (HBV DNA ≥ 1000 cps/mL or 200 IU/mL) requiring therapy.
13. Subjects with active infection of tuberculosis.
14. Subjects with signs or symptoms of any active infection requiring systemic therapy.
15. History of organ transplantation.
16. Unresolved toxicities from prior anti-cancer therapy.
17. History of any irAE of Grade ≥ 3.
18. History of uncontrolled allergic asthma and serious hypersensitive reaction to monoclonal antibodies.
19. History of alcoholism or drugs abuse.
20. Subjects with major cardiovascular diseases.
21. Any condition that, in the opinion of the investigator or sponsor, would jeopardize compliance.

For more information regarding trial participation, please contact at cstonera@cstonepharma.com
Personality Type as a Predictor to Develop Depression and Reduction in Quality of Life Among Stroke Survivals.

Personality type as a predictor to develop depression and reduction in quality of life among stroke survivals.


Eligibility Criteria:
Inclusion Criteria:

* any stroke,
* age 40-90,
* able to sigh informed concent,
* able to fill in the questionnaires.

Exclusion Criteria:

* non stroke,
* previous depression,
* not able to give consent or answer the questions.