cyrilzakka/clinical-trials huggingface dataset:
Effect of Dried Fruit on Cardiometabolic Risk Factors

This is a 2-period randomized crossover study with free-living subjects on self-selected diets. The objective of this study is to compare the effects of ¾ cup of a blend of dried plums, figs, dates and raisins (DPFDR) with an isocaloric and macronutrient matched snack food on blood pressure, vascular health and lipids and lipoproteins in 50 participants who are representative of the U.S. population and at risk for cardiovascular disease (overweight/obese, elevated LDL-cholesterol, prehypertension, and/or prediabetes).

The investigators hypothesize that the inclusion of DPFDR in the diet will decrease blood pressure and LDL-cholesterol, and improve artery function (assessed by standard blood pressure measure, 24 hr ambulatory blood pressure, central blood pressure and arterial stiffness) compared to the control group and baseline.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index of 25-36 kg/m2

And, at least one of the following:

* LDL-C above 116 mg/dL (3.0 mmol/L)
* Systolic blood pressure 120-159 mmHg
* Diastolic blood pressure 80-99 mmHg
* Increased waist circumference: ≥94 cm for men and ≥80 cm for women
* Elevated glucose (≥ 100 mg/dL and \< 126 mg/dL)
* Triglycerides: above 150 mg/dL (1.69 mmol/L) and below 350 mg/dL (3.95 mmol/L)
* Low HDL-cholesterol: \<40 mg/dL (\< 1.03 mmol/L) for men and \< 50 mg/dL (\<1.29 mmol/L) for women)

Exclusion Criteria:

* Allergies to the test foods
* History of cardiovascular disease, stage II hypertension (BP 160/100 mmHg), kidney disease, diabetes or inflammatory diseases such as gastrointestinal disorders and rheumatoid arthritis
* Use of medication/supplements for elevated lipids, blood pressure, or glucose
Baclofen for the Treatment of Alcohol Drinkers

The main objective of this study is to show the effectiveness to a year of baclofen compared to placebo, on the proportion of patients with a low risk alcohol consumption or no, according to the WHO standards.

Baclofen, a gamma-aminobutyric acid 'B-receptor' agonist, has long been used to treat spasticity from neurological diseases, at a dose of 30-90 mg/day. It appears today to be a promising but controversial candidate for treating alcoholic patients (Enserick, 2011) by reducing or even suppressing their craving to drink. A few case reports (Ameisen, 2005; Bucknam, 2007; Dore et al., 2011) and a retrospective study (Rigal et al, 2012) suggest that some patients might respond favorably to baclofen at higher doses than 90 mg/day. This is a randomized controlled trial versus placebo testing such doses.

An extraction of patients DNA and a genetic analysis will be done after the end of the trial. In a gene candidate approach, the association of several genes with the efficiency of the treatment and its side effects, based on the literature, will be investigated using micro-array technology.

Eligibility Criteria:
Inclusion Criteria:

* Patient coming for a problem with alcohol (alcohol at high risk during the past three months (at least two times during each month) according to the WHO standards;. i.e.: in women more than 40 g per day or 280 g per week or more of 40 g at once; the man more than 60 g per day or 420 g per week or more than 60 g in once, and expressing the desire to be abstinent or to have a consumption to low level of risk).
* Volunteer to participate in the trial and having given his consent written after appropriate information
* Patient having no treatment for the maintenance of abstinence (acamprosate, naltrexone) and the prevention of relapse (disulfiram) for at least 15 days before the beginning of the trial
* Patient informed about the possibility of drowsiness in relation to the treatment and the associated risks to drive vehicles (motorized or not), the use of machines (including domestic use or recreation) and the execution of tasks requiring attention and precision
* Including woman of childbearing age (but taking effective contraception).

Exclusion Criteria:

* Patient taking already baclofen or having taken baclofen
* Patient pregnant, lactating, or childbearing years in the absence of effective contraception
* Patient with porphyria
* Patient with Parkinson's disease
* Patient with severe psychiatric pathology (psychosis, including schizophrenia and bipolar disorders) that can compromise the observance
* Patient with organic disease serious enough to not to allow its inclusion in the study according to the opinion of the investigator
* Patient homeless
* Patient without social cover
* Patient unable to properly follow-up book, cannot commit to one year of follow-up
* Patient with a contraindication to taking baclofen (intolerance to gluten by the presence of wheat starch
* Patient with a severe intolerance known about the lactose
The Efficacy, Safety and Genetic Polymorphism of Hypoca and Adalat OROS in Hypertensive Patients

Nifedipine and barnidipine act as calcium channel blockers, and are widely prescribed for pressure control of prehypertension and stage 1 hypertension.

CYP3A4 is responsible for the metabolism of nifedipine and nifedipine, while the contribution of CYP3A5 remains ambiguous. This study is aimed to analyze the association between antihypertensive effects of nifedipine as well as barnidipine and single nucleotide polymorphisms of CYP3A4, CYP3A5 and calcium channels.

For each drug, 20 patients will be enrolled. Patients' blood pressure and heart rates will be measured at first visit, followed by visits at week4 , week 8 and week 12. Blood samples will be drawn at week 4 and week 12 for following analyses of drug plasma concentrations. SNPs in CYP3A4, CYP3A5 and calcium channel v 1.2 will be genotyped using SNPstream.

The differences in the decrease of blood pressures and the durg plasma concentrations between genotypes will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* 20\~90 years old patient
* mild to moderate hypertensive patients
* can finish this study
* can sign agreement

Exclusion Criteria:

* severe hypertension
* Heart failure, Arrhythmia
* Liver or kidney failure
* pregnant women
* allergy to dihydropyridines
* attend other clinical trials in past 3 month
Epidemiology of Long QTand Asian Sudden Death in Sleep

To conduct a cross-sectional epidemiologic study of the determinants of prolonged heart rate corrected QT interval (QTc) among 300 men and 300 woman in the population with the highest known risk of SUDS: Southeast Asian refugees in Thailand. .

BACKGROUND:

Sudden and unexplained death in sleep (SUDS) is a leading cause of death of young men in several Asian populations. The immediate cause is ventricular fibrillation in the absence of known disease. A strong environmental component may be inferred from the regional nature of SUDS in groups that are culturally and genetically distinct and the rapid decline in rates of SUDS after migration of Southeast (SE) Asian refugees to the United States. Risk of SUDS rises sharply to a peak among men aged 35 years of age, then declines with increasing age. In a pilot studies of SE Asian refugee men in Thailand with the highest known risk of SUDS, the investigators documented high-prevalences of prolonged heart rate corrected QT interval (QTc), thiamine deficiency, hypokalemia, and a positive association between poor thiamine status, measured by erythrocyte transketolase activity (ETK), and QTc. These limited studies were unable to precisely quantify the relationship between QTc and thiamine status, lacked sufficient power to examine the relationship between QTc and hypokalemia, did not include other electrolytes, and did not address the striking differences in risk of SUDS by sex and age.

DESIGN NARRATIVE:

The study was cross-sectional in design. During a 14-month period, informed consent was obtained from subjects selected in an age-stratified random sample of refugees scheduled for routine medical screening. Blood samples, 12-lead and 24-hour ECGs, and interview data were collected to test the following hypotheses: (1) mean QTc was greater in men than women, (2) mean QTc was greater in men aged 30-39 years than in men younger or older; no similar relationship was expected among women, (3) QTc was positively correlated with poor thiamine status, measured by erythrocyte transketolase activity, (4-6) QTc was negatively correlated with serum levels of potassium, magnesium, and total calcium, and (7) QTc was associated with abnormalities of autonomic control of the heart, as indicated by power spectral analysis of heart rate variability. Secondary aims included studying interactions of thiamine status and electrolytes in the prolongation of QTc, dynamic analysis of QT variation by heart rate level in 24-hr ECGs, and collection of blood specimens for later genetic studies

Eligibility Criteria:
No eligibility criteria
Feasibility and Quality of TeleConsultation in Pediatric Anesthesia

Teleconsultation (TLC) being a new method of anesthesia consultation, deployed as an emergency in healthcare facilities in the Covid context, it has never been evaluated either in terms of feasibility or in terms of quality. An initial assessment will highlight the pitfalls and difficulties encountered and suggest areas for improvement.

The evaluation of teleconsultation in pediatric anesthesia, a new consultation method developed in the context of COVID for several weeks, appears necessary and will be a first inventory after its implementation in France. Analysis of the data collected in this study will allow us to propose technical, medical and organizational solutions to optimize the positioning and practical use of TLC for patients and care facilities. This assessment step seems imperative if the Covid context persists over time but could also be useful for the development of TLC outside the Covid context.

Eligibility Criteria:
Inclusion Criteria:

* All patients under the age of 18 requiring an anesthesia consultation for an act requiring anesthesia
* whose deprogramming in the context of the Covid 19 pandemic would lead to a loss of opportunity for the patient,
* Or whose programming in the context of the Covid 19 pandemic is in accordance with the recommendations made in field of the Professional Practice Recommendations
* And for which the family and the anesthetist have agreed to carry out the consultation by telemedicine

Exclusion Criteria:

* Patient whose anesthesia consultation is performed face-to-face as a first-line decision
* Family refusing teleconsultation
A Study to Evaluate White Matter Hyperintensities in Migraine

The purpose of this research is to better understand brain white matter hyperintensities (WMH) in women with migraines


Eligibility Criteria:
Inclusion Criteria - Migraine (N=20):

* Female only.
* Ages 20-45 years.
* Presence of WMH on MRI.

Exclusion Criteria:

* History of SVI and/or history of MS or other neurological disease other than migraine.
* History of cancer or organ transplantation.
* Contraindication to MRI.
* Pregnancy.
* History of abnormal brain MRI other than WMH.
* Subjects not willing to comply with the study procedures will be removed from the study.

Inclusion Criteria - SVI disease (n=10):

* Female only
* Ages \> 60 years.
* Presence of WMH on MRI.

Exclusion Criteria:

* History of migraine and/or history of MS or other neurological disease other than SVI.
* History of cancer or organ transplantation.
* History of abnormal brain MRI other than WMH.
* Pregnancy.
* History of abnormal brain MRI other than WMH.
* Subjects not willing to comply with the study procedures will be removed from the study.

Inclusion Criteria - MS (n=10):

* Female only.
* Ages 20-45.
* Presence of WMH on MRI.

Exclusion Criteria:

* History of migraine and/or history of SVI or other neurological disease other than MS.
* History of cancer or organ transplantation.
* History of abnormal brain MRI other than WMH.
* Pregnancy.
* History of abnormal brain MRI other than WMH.
* Subjects not willing to comply with the study procedures will be removed from the study.
Clinical Trial to Improve Treatment With Blood Thinners in Patients With Atrial Fibrillation

To determine whether a comprehensive evaluation and customized multilevel educational interventions will increase the rate of use of oral anticoagulants and the adherence and persistence of use in patients with atrial fibrillation. Our hypothesis is that there will be differences in the use of oral anticoagulants and the persistence in patients between the control and interventional group. There will be a greater change in the use of oral anticoagulants over one year in the cohort in the intervention sites than the control sites. This will be due to two factors: greater initiation of oral anticoagulants among patients not treated at baseline and greater persistence of treatment for those on treatment at baseline


Eligibility Criteria:
Inclusion Criteria:

* 1. Patients over the age of 18 with paroxysmal, persistent or permanent atrial fibrillation who have a 12-lead ECG showing atrial fibrillation and/or more than one rhythm strip showing atrial fibrillation at least 2 weeks apart, not due to a reversible cause (like post-CABG))
* 2. At least one of the traditional CHADS2 risk factors or at least two CHA2DS2 VASc risk factors

Exclusion Criteria:

* Mechanical prosthetic valve
* Clinically unstable at the time of enrollment (ie, with ongoing shock)
* Terminal illness and/or comfort care
* Unable to provide consent (e.g. severe cognitive impairment)
* Patients unable to have one year of follow-up for any reason
* Clear and absolute contraindication to oral anticoagulation (for example, active bleeding or recent life-threatening bleeding such as ICH)
The Effect of Vaginal Speculum Type and Retention Time on Pregnancy Outcomes During the Embryo Transfer Process

Investigators aim to investigate possible affects of a speculum material and retention strategy on IVF pregnancy results. The study is planned as a prospective, randomized control trial. All of the clinical managements, including the embryo transfers, will be performed by the same gynecologist for homogeneity of the study. Only the cases with good implantation potentials are going to be included. Therefore, transfers with cleavage embryos and blastocysts rather than good and top quality will be excluded. All patients included to final statistical analysis will receive the same luteal support.

Participants will be included among the 20 - 40 years old women applying to for IVF. Women with mullerian anomalies and couples with chromosomal abnormalities will be excluded. Histrory of recurrent implantation failure, thin endometrium will also be considered as exclusion criterias. Participants who are initially included in the study will be excluded either the demanded preimplantation genetik testing for aneuploidy optionally, or if the embryo transfer is performed under general anesthesia or the embryo transfer is recorded as difficult transfer.

The participants included in the study will be randomised for the speculum material ( metal or plastic) and also for the retention time of the speculum out of the vagina. Just immediately before applying the speculum to the patient, the material temperature will be measured and recorded with a thermometer capable of digital and object measurement.

All of the transfers will be performed with the same technique. After the embryo transfer is made and the transfer catheter is withdrawn, the speculum will be extracted according to the randomization. If the speculum is not extracted immediately, the chronometer will be started and the extraction will be done either in the 60. second or 420. second ( 7 minutes) according to the randomization . As there are two speculum materials and three retention time arms in the design, a total of 6 groups will be formed after crossover. Data gained in this way will be analyzed and their demographic data and embryological parameters will be evaluated and the implantation rates, pregnancy rates and clinical pregnancy rates of the patients will be determined.

Eligibility Criteria:
Inclusion Criteria:

* women aged 20-40
* cases that good and top quality embryos are achieved for embryo trasnfer

Exclusion Criteria:

* recurrent implantation failure
* any known genetic problems of couple
* any known mullein anomalies
* PGT-A cases
* thin endometrium
is There an Alternative to Ultrasound Guided Interscalene Block?

Interscalene brachial plexus block is the gold standard for perioperative pain management in shoulder surgery. However, this technique would have side effects and potential serious complications. The aim of this study is to compare between the combination of ultrasound guided suprascapular and supraclavicular nerve blocks versus ultrasound guided interscalene brachial plexus block for post operative analgesia after shoulder instability surgery with latarjet procedure.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-III
* 18-75 years of age, inclusive
* shoulder surgery (LATARJET technique)

Exclusion Criteria:

* contraindications to brachial plexus block (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area)
* existing neurological deficit
* pregnancy
* history of neck surgery or radiotherapy
* severe respiratory disease
* inability to understand the informed consent and demands of the study
Bisphosphonate-Associated Jaw Osteonecrosis and PET Imaging

1. Bisphosphonate-associated osteonecrosis of the jaw(ONJ)is detectable by positron emission tomography(PET).
2. Bisphosphonate-associated ONJ can be diagnosed and characteristically differentiated from other bony pathologies of the jaw(osteomyelitis, osteolytic lesions, and osteoradionecrosis)by PET imaging.

Is to review medical records of approximately 1000 patients with bisphosphonate-associated ONJ who have had PET imaging at the time of diagnosis. Also to review medical records of patients who have been diagnosed with jaw osteomyelitis, osteoradionecrosis, and cancerous lytic lesions who received PET imaging at the time of diagnosis.

If sufficient information regarding presentation and treatment cannot be obtained form the medical record, approximately 300 patients will contacted by mail (and phone if necessary) by the PI or sub-investigators to question them regarding the onset of symptoms, treatment interventions, and outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of bisphosphonate-associated ONJ, osteomyelitis, osteoradionecrosis,and osteolytic lesions who received PET imaging at presentation

Exclusion Criteria:

* Anyone who has not been diagnosed with bisphosphonate-associated ONJ, osteomyelitis, osteoradionecrosis,or osteolytic lesions who received PET imaging at presentation
Bioequivalence Between Single Administration of ASC-01 (Aripiprazole/Sertraline Combination Drug) and Concomitant Single Administration of Aripiprazole and Sertraline, and Food Effect on Pharmacokinetics of ASC-01 in Healthy Male Adults

To investigate the bioequivalence of aripiprazole between administration of one ASC-01 tablet (aripiprazole 3 mg/sertraline 100 mg combination drug) and concomitant administration of one aripiprazole 3-mg tablet and two sertraline 50-mg tablets (Cohort 1).

To investigate food effect on plasma pharmacokinetics of aripiprazole and sertraline by single oral administration of ASC-01 under a fasting or fed condition (Cohort 2).


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subject at the age between 20 and 40 at the time of informed consent
* Subject has a body mass index (BMI = body weight \[kg\]/height \[m\]2) of ≥18.5 and \<25.0 kg/m2 at screening
* Subject is providing consent for participation in this trial in writing prior to the start of the procedures related to this trial, and judged by the investigator or subinvestigator to be capable of observing procedures in this trial.

Exclusion Criteria:

* Subject has a clinically significant abnormality in physical findings at screening or in medical history that in the investigator's or subinvestigator's opinion may place the subject at risk or interfere with outcome variables including drug absorption, distribution, metabolism, and excretion.
* Subject is judged by the investigator or subinvestigator to be inappropriate for participation in this trial.
MR/PET in the Evaluation of Patients With Esophageal Cancer

In this prospective study, we will recruit newly diagnosed esophageal cancer patients and perform MR/PET before and after chemoradiation therapy. In MR, new image sequences will be added to the conventional sequences, such as high resolution image, DWI, DCE, cine imaging.

Total 80 patients will be recruited and followed after treatment complete for at least two years. We will compare the staging accuracy of MR/PET and PET/CT, and also analyze parameters that are predictive of disease recurrence and patient survival.

Eligibility Criteria:
Inclusion Criteria:

1. newly diagnosed esophageal cancer patient
2. age older than 20 years

Exclusion Criteria:

1. For the safety reason, patients with the following conditions are contraindicated to enter magnetic resonance imaging (MRI) machine due to the high magnetic field, including: cardiac pacemaker, metallic artificial valve, intracranial and mediastinal vascular clips, cardiac defibrillator, nerve stimulator, implanted drug deliver system, metallic foreign body in the eye globe, cochlear implant, metallic fragments in the dangerous body part, Swan-Ganz catheter, and other metallic implants within 8 weeks: such as cardiac valve, stent, coil, filter, and clips.
2. patient who will receive endoscopic local therapy alone
3. unable to finish the standard surgical or radiation treatment
4. history of surgery or radiotherapy to the mediastinum
5. renal insufficiency, contraindication to MR imaging and contrast injection patient who have the severe allergic reaction the Gadollium contrast agent
6. patient who have the claustrophobic symptoms are also not suitable for this MR examination
7. pregnancy or lactating women
Pilot Study of Zoledronic Acid in Combination With First-line Chemotherapy in Aged Patients With Lung Cancer

Pilot study of Zoledronic acid in combination with first-line chemotherapy in aged patients with lung cancer. The purpose is to assess the effects of Zoledronic acid in combination with first-line chemotherapy in aged patients with lung cancer on bone mineral density gain in the lumbar spine and total hip.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form
* Age ≥70 years
* Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
* Histologically or cytologically confirmed lung cancer
* Did not receive bisphosphonate treatment

Exclusion Criteria:

* Appear relapse and metastasis
* receive other bisphosphonate treatment
* Active or uncontrolled infection
* Pregnant or lactating women