cyrilzakka/clinical-trials huggingface dataset:
Brain Electrophysiological Patterns in Obesity

There is growing evidence of behavioural and neurobiological overlaps between obesity and drug abuse. Reduction of the amplitude of P300, a component of event-related potentials (ERP) elicited by an oddball paradigm, is an electrophysiological characteristic and a marker of vulnerability in substance abuse. We want to determine whether obesity is associated with such electrophysiological features during an auditory oddball paradigm. We postulate that obesity could be associated with electrophysiological abnormalities that could be viewed as a possible vulnerability marker for food addiction.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria for the study are men and women aged 20-60 years, BMI 18.5-24.9 kg/m2 for control subjects and BMI\>30 kg/m2 for obese subjects, stable body weight over the previous 3 months, report of sedentary or moderate physical activity

Exclusion Criteria:

* The exclusion criteria are pregnancy, post-menopausal women, any physiological or psychological illness that could influence the results, subjects likely to take medical drugs interfering with the electrophysiological parameters of the study, diabetes, hearing disorder, intense physical activity and report or evidence of excessive alcohol consumption, depressive state or eating disorders according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV).
VitaFlow™ II Transcatheter Aortic Valve System Pre-market Trial

This is a pre-market clinical investigation aiming to evaluate the safety and effectiveness of Microport™ CardioFlow VitaFlow™ II Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.

This a prospective, multi-center, single-arm, objective performance clinical investigation, aiming to evaluate the safety and effectiveness of Microport™ CardioFlow VitaFlow™ II Transcatheter Aortic Valve System for the treatment of severe aortic stenosis. A total of 145 subjects will be enrolled in 18 clinical centers within China. Clinical or telephone follow-up is scheduled at 30 days, 6 months, 12 months, and 2-5 years after valve implantation.

Eligibility Criteria:
Inclusion Criteria:

1. Age≥70 years;
2. Symptomatic , severe, aortic valve stenosis : peak velocity ≥4.0m/s, or mean transvalvular gradient ≥40mmHg(1 mmHg=0.133kPa), or effective orifice area\<0.8cm² (or EOA index\<0.5cm²/m²);
3. NYHA≥II class;
4. Estimated life-expectancy\>12 months after implantation of the prosthetic valve;
5. Anatomically suitable for the transcatheter aortic valve implantation procedure;
6. The patients considered to high-risk or not suitable for surgical aortic valve replacement (SAVR), as assessed by two or above heart surgeons; The patient has been informed of the nature of the study, is willing to enroll in the study by signing a patient informed consent and agreeing to the scheduled follow up requirement.

Exclusion Criteria:

1. Acute myocardial infarction (MI) in last 30 days before the treatment;
2. Aortic root anatomy not suitable for the implantation of the transcatheter aortic valve；
3. Complicated lesion of the aortic valve (aortic stenosis with severe regurgitation); moderate-severe mitral valve stenosis; severe mitral valve regurgitation; severe tricuspid valve regurgitation;
4. Previous implantation of heart valve at any position；
5. Hemodynamic instability requiring mechanical hemodynamic support devices;
6. Need for emergency surgery for any reason;
7. Hypertrophic cardiomyopathy with obstruction;
8. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) \< 20%;Severe right ventricular dysfunction;
9. Active peptic ulcer or upper gastro-intestinal bleeding within the past 3 months;
10. Known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens, to nitinol, contrast media or other relevant elements.
11. Congenital aortic valve stenosis or unicuspid aortic valve;
12. Vascular diseases or anatomical condition preventing the device access;
13. Active endocarditis or other active infections at the time of treatment;
14. Participating in another trial and the primary endpoint is not achieved.
15. Inability to comply with the clinical investigation follow-up or other requirements.
Can Frailty Inform the Management of Hypertension in Older People?

The purpose of this study was to investigate in large scale routine primary care data whether frailty is a prognostic factor for relevant outcomes in the management of hypertension in older people and whether frailty causes effect modification of the association of blood pressure or blood pressure lowering treatment and outcomes in older people.

A retrospective cohort study used linked electronic health records from the Welsh Secure Anonymised Information Linkage (SAIL) databank. All patients had hypertension in the absence of established cardiovascular disease, and were over the age of 65 years in 2007. Systolic blood pressure and frailty, measured using the electronic frailty index were recorded. Patients were followed up for ten years. Time to event analysis measured first ever major adverse cardiovascular or cerebrovascular event (MACCE), all-cause mortality and injurious falls. Adjustment was made for established cardiovascular risk factors.

Eligibility Criteria:
Inclusion Criteria:

* Patient registered with a general practitioner contributing to SAIL database for at least 1 year
* Patient with blood pressure measured and recorded at any time after 1st January 2007 and before 1st January 2008, was used as the individual's index start date.
* Patient aged 65 years or older at the time of study entry.

Exclusion Criteria:

* Patient did not have a diagnosis of hypertension or did not have blood pressure meeting criteria for hypertension;
* Patient had an established history of cardiovascular disease (previous stroke, heart failure or myocardial infarction) prior to the start date.
Study Evaluating Venlafaxine ER in Adults With Panic Disorder

The primary objective of this study is to determine the efficacy, safety, and tolerability of a flexible dose of venlafaxine extended-release (ER) capsules administered for 10 weeks in the treatment of adult outpatients with panic disorder (PD) in a placebo-controlled phase III study.


Eligibility Criteria:
Inclusion Criteria:

* A male or female outpatient
* Be at least 18 years of age and legal age of consent
* Meet DSM-IV criteria for PD (with or without agoraphobia) for at least 3 months before study day 1

Exclusion Criteria:

* Treatment with venlafaxine (IR or ER) within 6 months of study day 1
* Known hypersensitivity to venlafaxine (IR or ER) or related compounds
* History or presence of any clinically important hepatic, renal, or other medical disease that might compromise the study or be detrimental to the patient (eg, clinically important cardiac arrhythmia, unstable diabetes, carcinoma \[except basal cell epithelioma\], uncontrolled hypertension)
Atlas of Human Milk Nutrients

The main objective of this clinical trial is to collect human milk samples from 0 to 4 months after delivery in order to characterize human milk components. The secondary objectives of this study are:

1. To assess whether there is a correlation between human milk composition and mothers' diet
2. To assess whether there is a correlation between human milk composition and maternal clinical parameters
3. To assess whether there is a correlation between human milk composition and mother and infant clinical parameters


Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 40 years of age included at time of enrolment
* BMI before pregnancy between 19 and 29 included
* Having signed the Informed Consent Form
* Having decided to exclusively breast-feed until infant is 4 months old

Exclusion Criteria:

* Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study
* Presenting any disease or medical condition which might prevent breast-feeding or collection the human milk samples or for which breast-feeding is not indicated
* Presenting diseases/medical conditions such as diabetes, heart problems, abnormal conditions of pregnancy (ex. hypertension)
* Presenting dietary problems/illnesses such as anorexia, bulimia and celiac disease
* Assuming any medication indicated for the treatment of any metabolic or cardiovascular disease
* Cannot be expected to comply with the study procedures
Simulated-altitude to Optimize Aerobic Exercise Among Breast Cancer Survivors With Limited Mobility

The study will evaluate the utility of hypoxic exercise training to improve cardiovascular and metabolic health among obese breast cancer survivors. While participants exercise, a lower fraction of inspired oxygen will be used to simulate a higher altitude. This approach removes the mechanical strain needed to sustain moderate-to-vigorous exercise intensity which is believed to support exercise tolerance. Participants are randomized to either the treatment (walking+simulated-altitude) or control (walking under normoxic conditions).

Cancer survivors have a two-fold greater risk of having one or more functional limitations compared to those without a history of cancer. Though exercise interventions in breast cancer survivors exist, a large portion of women (61%) exhibit some form of lower-body dysfunction that severely restricts participation in physical activity and exercise. Both physical and emotional well-being are negatively affected by the combination of increased adiposity, orthopedic problems and muscle weakness, thus reinforcing a cycle of physical inactivity.

For these reasons, obese breast cancer survivors with walking limitations are faced with a barrier that greatly increases the difficulty of meeting prescribed exercise guidelines (≥150 weekly minutes of moderate-to-vigorous intensity exercise). Though previous investigations have demonstrated the safety and benefits of exercise+simulated altitude to improve body fat, physical endurance and insulin sensitivity, results have been limited to non-cancer participants only. Given the comorbidities common to breast cancer survivors, specifically, heart disease risk, lower body joint problems, low aerobic capacity, and fatigue, further research is needed.

Eligibility Criteria:
Inclusion Criteria:

1. Physician's medical clearance for participation
2. English-speaking women
3. 18-70 years of age with a history of Stage 0-III breast cancer
4. Preferred walking speed of less than 2.9 mph as measured by a timed 10 meter walk test (to be performed on-site after consent during preliminary screening) "OR" the inability to complete a 6-minute walk without stopping (to be performed on-site after consent during preliminary screening)
5. Body mass index between 30-45 kg/m2
6. ≥1 year post-treatment and not currently receiving or planning to receive chemo/radiation therapies
7. Not participating in a structured exercise routine
8. In the previous 6 months, not engaging in (on average) ≥60 minutes of moderate or ≥30 minutes of vigorous physical activity per week.

Exclusion Criteria:

1. Males
2. Dementia
3. Medical, psychological, and/or social characteristics that may interfere with the ability to fully participate in the proposed study activities/assessments (e.g., psychosis, schizophrenia)
4. Contraindication to participate in regular exercise training
5. Unwilling to complete prescribed exercise
6. Inability to walk
7. Pregnant
8. Resting oxygen saturation via pulse oximetry below 90%
9. Using home oxygen therapy
The Advocate Study

Hollister Incorporated is studying stoma related cost of care related to a new ostomy skin barrier that is designed to maintain adhesive properties and good peristomal skin health compared to other currently marketed barriers.


Eligibility Criteria:
Inclusion Criteria:

Ostomy patients who:

* Have healthy peristomal skin
* Are within 12 weeks post op

Exclusion Criteria:

Ostomy patients who:

* Have a fistula, wound, lesion or suspected infection in the peristomal area
* Are in-patient in healthcare facility
Growth Hormone for Osteoporosis Pseudoglioma Syndrome

Osteoporosis pseudoglioma (OPPG) syndrome is a rare autosomal recessive condition of childhood osteoporosis and congenital blindness for which new treatments are needed. We have found that body fat is increased in OPPG and muscle mass is reduced. We hypothesize that growth hormone therapy will improve muscle mass and bone strength in OPPG.

Osteoporosis pseudoglioma (OPPG) syndrome is a rare autosomal recessive condition of childhood osteoporosis and congenital blindness for which new treatments are needed. We have found that body fat is increased in OPPG and muscle mass is reduced. We hypothesize that growth hormone therapy will improve muscle mass and bone strength in OPPG.

Eligibility Criteria:
Inclusion Criteria:

* Osteoporosis pseudoglioma syndrome
* Age 4 years and above
* not on medication for osteoporosis

Exclusion Criteria:

* pregnant
* Age under 4 yrs
* Active malignancy
Fresno FAWDB FIRE Program Evaluation

The purpose of the Fresno Area Workforce Development Board FIRE program evaluation is to determine whether primary (i.e., behaviors) and secondary (i.e., attitudes) outcomes improve for participants after completing the Fresno FIRE program. Understanding the ways in which the Fresno FIRE program supports healthy parenting relationships and financial stability is important for those providing services to at-risk fathers.

After being informed about the study and giving consent, participants will enroll in a nine-week Fresno Fatherhood program that collects data at enrollment, at the end of the program, and 12 months following the program. Research questions in this study are framed by a descriptive evaluation design to assess whether outcomes improve for low-income fathers who participate in the Fresno FIRE program. Primary and secondary outcomes are assessed before and after participants complete core curricula - 24/7 Dads and career readiness workshops (pre to post). Primary outcome measures will indicate whether behavior improved for healthy family relationships (parent, co-parent, and partner) and economic stability (financial, employment). Secondary outcomes will indicate whether improvements were made in the attitudes and expectations that facilitate and reflect behavior for healthy family relationships and economic stability.

Eligibility Criteria:
Inclusion Criteria:

* Adult (age 18 and older)
* Father/father figure of child under 24 years of age
* Residing in Fresno area, CA
* Has at-risk factors (residing in high poverty area, formerly justice-involved)

Exclusion Criteria:

* Minor (under the age of 18)
* Not a father/father figure
* Father of a child over 24 years of age
* Reside outside of Fresno area, CA
Sleep Apnoea Breathing Record Exploratory Study (SABRES)

During sleep, many people have times when they breathe shallowly or completely stop. If a person stops breathing for more than 10 seconds, this is called an 'apnoea'. If shallow breathing lasts for more than 10 seconds, it is called a 'hypopnoea'. If a person has these events frequently, it disrupts their sleep and they do not awake refreshed. It can also put strain on the heart, leading to cardiovascular conditions. These sleep disorders, usually called 'Sleep Apnoea', can be treated for most people using 'continuous positive airways pressure', CPAP. Current tests for sleep apnoea, usually used at home, are expensive, complicated for patients to use and do not monitor actual breathing. The new test, called Apne-Scan, is very simple and will cost less than the standard tests. It just requires the user to wear a mask, similar to ones used for CPAP treatment, overnight and then send the mask off for data analysis. The Apne-Scan mask, developed with taxpayer funding, is fitted with a pressure sensor to monitor actual breathing. People between the ages of 18-70 who have been referred to the sleep clinic at Royal Stoke University Hospital are eligible to participate in this exploratory study. They will wear the Apne-Scan mask at the same time as their standard overnight sleep apnoea test. The breathing data collected by Apne-Scan will be analysed by Apnea-Tech Limited, the device manufacturers, so that it can be compared to the data captured by the standard sleep apnoea test.


Eligibility Criteria:
Inclusion Criteria:

* Have been referred by a clinician to the sleep clinic for diagnosis of a sleep disorder, possibly sleep apnoea.
* Be about to be screened for possible sleep apnoea using a standard sleep apnoea test device.
* Be between the ages of 18 and 75 and have provided informed consent for the study

Exclusion Criteria:

* Have not been referred by a clinician to a sleep clinic for diagnostic tests for sleep disorders other than for possible sleep apnoea.
* Cannot tolerate wearing a mask overnight.
* Cannot remove a mask should they become distressed.
* Are not capable of understanding the English language version of Apne-Scan's Instructions For Use (IFU).
* Are under the age of 18 years old or over the age of 75 years old.
* Are not capable of giving informed consent
Maternal Serum Level of ACTH as a Predictive Marker of Preterm Labor in Patients With Threatened Preterm Labor

The aim of this study is use of ACTH as a predictive marker in patients of threatened preterm labor .

This is a cross sectional study that will include 261 pregnant women aged between 17 and 35 years with singleton pregnancies between 28 and 36 completed weeks of gestation that had been diagnosed with threatened preterm labor and consented to participate in this study. This study will be conducted at Ain Shams University Maternity Hospital after approval of the research and ethics committee.

the investigators include all patients which have these following criteria (Singleton pregnancy, Age between 17 - 35 years, Gestational age between 28 and 36 weeks and Diagnosis of threatened preterm labor is based on the American College of Obstetricians and Gynaecologists Guidelines (ACOG, 2003): Presence of uterine contractions (at least 4 in 20 minutes or 8 in 60 minutes), Cervical dilation \> 1 and \< 4 cm, and/or Cervical effacement ≥ 80%.

the investigators exclude any patient which has any of the following criteria (Preterm rupture of membranes, Any uterine anomalies or cervical incompetence, Chronic illness such as chronic hypertension or kidney disease, Diabetes mellitus, Abruptio placenta, Preeclampsia and HELLP syndrome, Fetal anomalies, IUGR, Smoking or Clinical signs of intrauterine infection).

blood sample was collected from each patient for measurement of ACTH level. According to local protocol in Ain Shams University Maternity Hospital all women will receive a fixed regimen of tocolysis in the form of nifedipine (Epilat) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 60 - 160 mg/day (1-2 tablets 3 times daily) of slowly releasing nifedipine (epilat retard 20 mg tablet) may be given depending on uterine activity. The patients will also receive 6 mg dexamethasone every 12 hours for 4 doses. All women will be followed up till delivery.

After delivery, the investigators divide the patients into 2 groups (full term delivery \& preterm delivery) and we compare between these 2 groups by level of hormone.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy.
* Age between 17 - 35 years.
* Gestational age between 28 and 36 weeks.
* Diagnosis of threatened preterm labor is based on the American College of Obstetricians and Gynaecologists Guidelines (ACOG, 2003): Presence of uterine contractions (at least 4 in 20 minutes or 8 in 60 minutes), Cervical dilation \> 1 and \< 4 cm, and/or Cervical effacement ≥ 80%.

Exclusion Criteria:

* Preterm rupture of membranes.
* Any uterine anomalies or cervical incompetence.
* Chronic illness such as chronic hypertension or kidney disease.
* Diabetes mellitus.
* Abruptio placenta.
* Preeclampsia and HELLP syndrome.
* Fetal anomalies.
* IUGR.
* Smoking.
* Clinical signs of intrauterine infection eg (uterine tenderness, foul vaginal discharge, maternal pyrexia ≥ 38°C and/or maternal leucocytosis).
Electrical Activity of the Diaphragm During the Weaning Period

The study aims to assess 1) the electrical activity of the diaphragm in mechanically ventilated patients during weaning from mechanical ventilation. 2) Whether the electrical activity of the diaphragm may predict the weaning outcome

Optimization of the time to liberate the patient from mechanical ventilation should be balanced between the risks associated with failed extubation and those related to prolonged mechanical ventilation. Weaning failure is associated with major complications. Even when weaning protocols and clinical predictors have been used to improve the weaning outcome, there is still a significant proportion of patients who fail to breath spontaneously with significant risks of pneumonia, prolonged mechanical ventilation and increased morbidity and mortality rate. Electrical activity of the diaphragm, a mirror of the respiratory drive and now available on an ICU ventilator may help to predict in a more accurate way the weaning outcome. The patients will be ventilated in NAVA with the titration method (1). As soon as patients passed successfully a daily screening EAdi will be measured during a spontaneous breathing trial.

Eligibility Criteria:
Inclusion Criteria:

* All patients older than 18 years and mechanically ventilated for \>= 48 h.
* In the resolving stage of the disease which brought to mechanical ventilation.
* Pao2/Fio2 ratio \>150 on positive end-expiratory pressure (PEEP) \<=8 cm H2O.
* Sedation discontinued for a minimum of 24 hrs
* Analgesia provided solely with morphine at a dosage of less or equal to 0.01 mg/kg/hr.
* Patient fully alert and cooperative.
* Intact respiratory drive evaluated with Glasgow Coma Scale \>=10.

Exclusion Criteria:

* The attending physician refuses to allow enrolment
* The patient refuses informed consent
* Hemodynamic instability despite adequate filling (i.e. need for continuous infusion of epinephrine or vasopressin, or dopamine or dobutamine \> 5 mcg/kg/min or norepinephrine \> 0.1 mcg/kg/min to maintain systolic arterial blood pressure \> 90 mmHg)
* No collaborative Patient
* Coagulation or platelets disorders
* neuromuscular disease
* phrenic nerve damage/diaphragm paralysis
* contraindication to exchange naso-gastric tube
* History of heart or lung transplantation
* Presence or suspicion of a central nervous system disorder