cyrilzakka/clinical-trials huggingface dataset:
Impact of Sustained Virologic Response on Glycemic Control Among Diabetic Patients With Hepatitis C Virus Related Liver Disease

Hepatitis C virus (HCV) is a major cause of chronic liver disease. The World Health Organization has reported that 170 million people are chronically infected with HCV globally. The highest prevalence of HCV infection worldwide exists in Egypt (15%); 90% of infection among Egyptian patients is due to genotype 4


Eligibility Criteria:
Inclusion Criteria:

* Chronic HCV infection will be diagnosed based on positive testing for serum HCV RNA and anti-HCV Ab.
* Diagnosis of type 2 DM will depend on fasting level of serum glucose more than 126 mg/dl and/or serum level of HbA1c more than 6.5 % on oral hypoglycemic therapy.

Exclusion Criteria:

* Chronic hepatitis due to causes other than HCV infection
* Coinfection with HBV infection
* Hepatocellular carcinoma
* Child C stage of liver cirrhosis.
* Patients with type I diabetes mellitus.
* Cardiopulmonary diseases.
* Major illness.
* Patient receiving corticosteroids.
* Patient refused consent.
Cognitive and Behavioral Therapy of Anxiety in Williams Syndrome

Patients with Williams-Beuren syndrome are eight times more likely to suffer from anxiety compared to the general population. Few therapeutic solutions are proposed to these patients. The objective of this research is to validate a cognitive and behavioral therapy anxiety protocol for patients with this syndrome.

Most studies agree that anxiety disorders are more frequent in people with intellectual disabilities that in the general population. Williams syndrome (WS) is a rare disease, associated with an anxiety rate 8 times higher than in the general population. The therapeutic solutions proposed in this population remain limited, in particular concerning approaches without the use of medication. The objective of the study is to evaluate the effectiveness of a program of Cognitive and Behavioral Therapies (CBT) in Williams Syndrome (WS). For this, an ABA-type protocol will be used. It consists of evaluating the effectiveness of an interventional program longitudinally, using a single case type study. Adults patients with WS and suffering from anxiety will be recruited. They will be enrolled in a program consisting in nine sessions of a psychotherapy program targeting anxiety. There will be a pretherapy visit (day 0), nine sessions of psychotherapy (month 0 to month 5) and a visit 3 month after the end of the therapy (at month 8) : the visit of the end of the research (V10). The expected results will be to validate a psychotherapeutic program for patients with WS suffering of anxiety. This program might be extended to other patients with intellectual disability.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Williams Syndrome
* Complaint about anxiety
* 18 years old and more
* Score of 7 or more at the CELF-4 (it is a scale assessing the language)
* informed consent signed

Exclusion Criteria:

* Scoring less than 7 at the CELF-4
* Hearing impairment
* Visual impairment
Perioperative Parathormone Measurement and Sodium Bicarbonate Infusion Test After Total Thyroidectomy

In the study will be included patients that have undergone total thyroidectomy and do not display obvious clinical or laboratory hypoparathyroidism. On the third postoperative day and before the patient's exit from the hospital, the patient will undergo an intravenous infusion test with 35ml/m2 dilution of 8.4%(w/v) sodium bicarbonate in two minutes. Three months after the operation, if the study conditions are still met, the patient will undergo an additional parathyroid hormone (PTH) measurement and sodium bicarbonate infusion test and the parathyroid function will be evaluated again.

Each patient will undergo a thorough preoperative examination for the presence of abnormalities in calcium, phosphate or magnesium metabolism as a consequence of a primary or a secondary disease.

Blood samples will be taken right before the beginning of the thyroidectomy, and 20 minutes after the end, to measure the PTH levels and to evaluate the variation rate.

On the third postoperative day and before the patient's exit from the hospital, the patient will undergo an intravenous infusion test with 35ml/m2 dilution of 8.4%(w/v) sodium bicarbonate in two minutes. Blood samples will be collected from a different vein at 0, 3, 5, 10, 30 and 60 minutes after infusion to measure PTH, calcium, phosphate and magnesium.

Three months after the operation, if the study conditions are still met, the patient will undergo an additional PTH measurement and sodium bicarbonate infusion test and the parathyroid function will be evaluated again.

In addition, the test will be performed on 50 healthy volunteers, in order to assess the response to the test of normal individuals.

Eligibility Criteria:
Inclusion criteria for the patient group

1. Patient is over 18 years old
2. Patient scheduled for total thyroidectomy
3. Patient signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures

Exclusion criteria the patient group:

1. Primary hyperparathyroidism
2. Primary hypoparathyroidism
3. Diabetes mellitus
4. Chronic Renal Failure
5. Hypoalbuminemia
6. Systematic Diseases (e.g., infections, neoplasmas)
7. Thyroid or parathyroid cancer
8. Osteoporosis
9. Drugs that influence calcium metabolism (vitamin D analogues, oral calcium supplements, biphosphonates, teriparatide, thiazide diuretics)
10. Osteomalacia
11. Neck irradiation

Inclusion criteria for the control group

1. Participant is over 18 years old
2. Participant signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures

Exclusion criteria of the control group:

1. All the above mentioned, in addition to prior thyroid surgery.
"COMBO-KEY" - A Home Visiting and Phone Coaching Programme to Promote Stroke Survivors' Recovery

Building confidence and capabilities to transfer rehabilitative knowledge and skills into lifestyle-workable strategies for changing health behaviours among stroke survivors are important to optimise health outcomes and reduce risks of recurrent stroke. The aim of this project is to promote stroke survivors' health by building confidence and positive expectations of recovery outcomes, and enabling their engagement in stroke self-management behaviours.

A randomised controlled trial will be conducted to determine the effectiveness of a programme "Coaching Ongoing Momentum Building On stroKe rEcovery journeY" ("COMBO-KEY"), a home visiting and phone coaching programme, on community-dwelling stroke survivors' self-efficacy, outcome expectation, and engagement in stroke self-management behaviours. An estimated sample of 134 stroke survivors will be recruited. COMBO-KEY will be underpinned by Bandura's constructs of self-efficacy and outcome expectation. It will be delivered by trained coaches. Outcomes will be measured at baseline and immediately after completion of the programme. Generalised estimating equations model will be used to assess the differential changes in outcome variables from pre-test to post-test between the intervention and control groups with adjustment for their baseline levels.

Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed with stroke
* 18 years old or above
* Community dwelling
* Have a modified Rankin Scale score equal to or greater than 3 (moderate to severe disability)
* Have a Montreal Cognitive Assessment score \>20

Exclusion Criteria:

* Have severe dysphasia
* Are diagnosed with a mental illness
RAte Control Efficacy in Permanent Atrial Fibrillation

The investigators hypothesis is that in patients with permanent AF lenient rate control is not inferior to strict rate control in terms of cardiovascular mortality, morbidity, neurohormonal activation, NYHA class for heart failure, left ventricular function, left atrial size, quality of life and costs. Lenient rate control is defined as a resting heart rate \<110 bpm.Strict rate control is defined as a mean resting heart rate \< 80 beats per minute (bpm) and heart rate during minor exercise \< 110 bpm. Patients will be seen after 1, 2, 3 months (for titration of rate control drugs) and thereafter yearly.

Study objectives:

1. To show that lenient rate control is not inferior to strict rate control in terms of cardiovascular mortality and morbidity
2. To show that lenient rate control is not inferior to strict rate control in terms of all cause mortality, cardiovascular hospitalizations, NYHA class for exercise tolerance, left ventricular function and left atrial size, quality of life, neurohormonal activation as measured by NT-proBNP, hospitalization for heart failure, syncope, sustained ventricular tachycardia, appropriate shocks or anti-tachycardia pacing of ICD for ventricular arrhythmias, cardiac arrest, and pacemaker implantations, stroke, systemic emboli, and bleeding, unstable angina pectoris and myocardial infarction, costs and renal function

Eligibility Criteria:
Inclusion Criteria:

* Patients with a current episode of permanent AF \< 12 months.
* Age \</= 80 years.
* Mean resting heart rate \> 80 beats per minute with or without rate control medication
* Oral anticoagulation (or aspirin if no risk factors for thromboembolic complications are present).

Exclusion Criteria:

* Paroxysmal AF
* Known contra-indications for either strict or lenient rate control (e.g. previous adverse effects on negative chronotropic drugs).
* Unstable heart failure defined as NYHA IV heart failure and heart failure necessitating hospital admission \< 3 months before inclusion.
* Cardiac surgery \< 3 months.
* Any stroke.
* Current or foreseen pacemaker and/ or cardiac resynchronization therapy.
* Signs of sick sinus syndrome or AV conduction disturbances (i.e. symptomatic bradycardia or asystole \> 3 seconds or escape rate \< 40 beats per minute in awake symptom-free patients).
* Untreated hyperthyroidism or \< 3 months euthyroidism.
* Inability to walk or bike.
Effectiveness of Yiqi Fumai Lyophilized Injection for Acute Heart Failure

The goal of this cohort study is to observe the effectiveness of Yiqi Fumai Lyophilized Injection (YQFM) in patients with acute heart failure (AHF). It mainly aims to assess the effectiveness of YQFM on the 90-day mortality or readmission rate in patients with AHF and compare the results with AUGUST-AHF RCT study. There will be no intervention, but information will be collected during the hospital stay and during the follow-up period of 180 days . Researchers will compare exposed group(patients who received YQFM) and non-exposed group(patients who didn't received YQFM) to see if there is difference on the 90-day mortality or readmission rate.

It mainly aims to assess the effectiveness of YQFM on the 90-day mortality or readmission rate in patients with AHF and compare the results with AUGUST-AHF RCT study. There will be no intervention, but patients will be asked to answer questions(such as scales or reporting of symptoms ) and provide biochemical or imaging tests, as well as undergo regular follow-up. Researchers will compare exposed group(patients who received YQFM) and non-exposed group(patients who didn't received YQFM) to see if there is difference on the 90-day mortality or readmission rate. We will also collect information on medication adherence during the follow-up period and remotely test patients during the follow-up period

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AHF
* Age≥18 years
* Voluntarily participate in and sign the informed consent form

Exclusion Criteria:

* With major psychiatric disorders or unable to complete follow-up assessment
* Known allergies to drugs or drug ingredients
* Patients enrolled in other trials within 1 month
Arterial Blood Pressure-complexity in Septic Patients

Arterial blood pressure (ABP) is regulated by multiple, interconnected feedback loops resulting in a variable and complex time course. According to the "decomplexification theory of illness", disease is characterised by a loss or impaired function of feedback loops resulting in a decreased complexity of the ABP-time course and an impaired adaptability of the cardiovascular system.

Decomplexification of physiologic parameters has been shown to occur in coronary heart disease, Parkinson's and Hodgkin's disease, and in subarachnoid hemorrhage, but has not been evaluated in sepsis.

This study is intended to test the hypothesis that complexity of ABP

* is lower in cardiac surgery versus non-cardiac surgery septic patients,
* decreases as severity of sepsis increases to severe sepsis and septic shock,
* is associated with outcome three month after sepsis.


Eligibility Criteria:
Inclusion Criteria:

* patients suffering from sepsis, severe sepsis or septic shock

Exclusion Criteria:

* pregnancy
Closed-loop Automatic Oxygen Control (CLAC-4) in Preterm Infants

Two-center, randomised controlled, cross-over clinical trial in preterm infants born at gestational age below 34+1/7 weeks receiving supplemental oxygen and respiratory support (Continous positive airway pressure (CPAP) or Non-invasive Ventilation (NIV) or Invasive Ventilation (IV)). Routine manual control (RMC) of the fraction of inspired oxygen (FiO2) will be tested against RMC supported by closed-loop automatic control (CLAC) with "slow"-algorithm and RMC supported by CLAC with "fast"-algorithm.

The primary hypothesis is, that the use of the "faster" algorithm results in more time within arterial oxygen saturation (SpO2) target range compared to RMC only. The a-priori subordinate hypothesis is, that the faster algorithm is equally effective as the slower algorithm to maintain the SpO2 in the target range.

BACKGROUND AND OBJECTIVE In preterm infants receiving supplemental oxygen, routine manual control (RMC) of the fraction of inspired oxygen (FiO2) is often difficult and time consuming. The investigators developed a system for closed-loop automatic control (CLAC) of the FiO2 and demonstrated its safety and efficacy in a multi-center study. The objective of this study is to test a revised, "faster" algorithm with a shorter WAIT-interval of 30sec (= time between FiO2 changes) against the previously tested algorithm (WAIT of 180sec) and against RMC. The primary hypothesis is, that the application of CLAC with the "faster" algorithm in addition to RMC results in more time within arterial oxygen saturation (SpO2) target range compared to RMC only. The a-priori subordinate hypothesis is, that the faster algorithm is equally effective as the slower algorithm to maintain the SpO2 in the target range.

Further hypotheses for exploratory testing are, that the "fast" algorithm will achieve a higher proportion of time with SpO2 within target range and an improved stability of cerebral oxygenation (measured as rcStO2 and rcFtO2E determined by Near-infrared spectroscopy) compared with the slow algorithm.

STUDY DESIGN The Study is designed as a two-center, randomized controlled, cross-over clinical trial in preterm infants receiving mechanical ventilation or nasal continuous positive airway pressure or non-invasive ventilation and supplemental oxygen (FiO2 above 0.21). Within a twenty-four-hour period the investigators will compare 8 hours of RMC with 8-hour periods of RMC supported by CLAC "slow" algorithm or "fast" algorithm, respectively.

Eligibility Criteria:
Inclusion Criteria:

* gestational age at birth \<34+1/7weeks
* invasive mechanical ventilation OR noninvasive ventilation OR continous positive airway pressure support
* Fraction of inspired oxygen above 0.21 before inclusion
* more than 2 hypoxaemic events (arterial oxygen saturation below 80%) within 8 hours before inclusion
* parental written informed consent

Exclusion Criteria:

* congenital pulmonary anomalies
* diaphragmatic hernia or other diaphragmatic disorders
Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Acute Treatment

This study will test the effectiveness and relative efficacy of behavioral and pharmacologic treatments, alone and in combination, for the treatment of binge eating disorder (BED) in patients with obesity. This is an acute treatment comparing behavioral weight loss alone or in combination with naltrexone/bupropion medication.

Binge eating disorder (BED), the most prevalent formal eating disorder, is associated strongly with obesity and bio-psychosocial impairment. Improved treatments for obese patients with BED are needed that can produce sustained clinical outcomes and promote weight loss. This study (acute treatment stage) aims to test the effectiveness of behavioral weight loss (BWL) and pharmacological treatment with Naltrexone/Bupropion (NB; a recently FDA-approved anti-obesity combination medication), alone and in combination, for the treatment of BED in patients with obesity. The acute treatment stage stage RCT will provide new findings regarding the effectiveness of NB medication and whether this specific combination of BWL and NB medication is effective for patients with obesity and BED. N=160 patients with BED and obesity will be randomly assigned (double-blind) in a balanced factorial (2 X 2) design trial, to one of four 16-week interventions: BWL+NB, BWL+Placebo, NB, or Placebo. This study will produce important new information about the relative efficacy of BWL and this recently FDA-approved anti-obesity (NB medicine), alone and in combination, for BED in patients with obesity.

Eligibility Criteria:
Inclusion Criteria:

* Binge eating disorder (full criteria as described in the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, 5th edition)
* BMI 27-30 with a controlled obesity-related co-morbidity; or BMI ≥ 30 and \<50;
* Available for the duration of the treatment and follow-up (20 months);
* Read, comprehend, and write English at a sufficient level to complete study-related materials;
* Able to travel to study location (New Haven, CT) for weekly visits.

Exclusion Criteria:

* Currently taking anti-depressant medications;
* Currently taking opioid pain medications or drugs;
* Currently taking medications that influence eating/weight;
* History of seizures;
* Current substance use disorder or other severe psychiatric disturbance (e.g., suicidality);
* Past or current anorexia nervosa, bulimia nervosa;
* Pregnant or breastfeeding;
* Medical status judged by study physician as contraindication.
Studying Infant Nutrition and Blood Sugar

The purpose of this study is to learn about how breast milk from mothers with insulin-resistance may be different. Investigators are specifically studying insulin concentrations in breast milk. Investigators are also studying how insulin in breast milk might affect a baby's intestines and pancreas.


Eligibility Criteria:
Inclusion Criteria:

* Mothers ≥ 19 years of age
* Mothers intending to Exclusively Breastfeed for at least 5months
* Mothers comfortable with feeding their infants expressed breast milk from a bottle at 2-weeks postpartum
* Trial of labor (no scheduled C-sections)
* Singleton birth
* Healthy Infants
* "Normal Weight" will be defined as pre-pregnant BMI between 18.5-23.9 kg/m2 and passing the 28 week oral glucose tolerance test.
* "Insulin Resistance" will be defined as meeting any of the following:

  * pre-pregnant BMI ≥ 28 and failed the 28 week oral glucose screening test
  * pre-pregnant BMI ≥ 28 and diagnosis of either A1 ("diet controlled") or A2 ("insulin-requiring") gestational diabetes during pregnancy, but insulin therapy discontinued after birth.
  * pre-pregnant BMI ≥ 28 and diagnosed with type 2 diabetes during pregnancy
  * pre-pregnant BMI ≥ 30, and unmediated.

Exclusion Criteria:

* Scheduled C-sections or emergency C-sections with no labor (natural or induced)
* Maternal insulin therapy after birth
* Significant maternal health concern including type 1 diabetes, renal, kidney, thyroid, or cardiovascular disease, pre-eclampsia, or other disease.
* Delivery before 37 weeks
* Infant birth weight \<2500g
* Infant medical or genetic indications that would impact normal feeding behavior, insulin signaling or growth patterns
* Infant supplementation with infant formula (glucose gel or donor milk is acceptable)
Verbal Cueing vs Constraint-Led Approach for Teaching the Kettlebell Swing

The purpose of this study is to determine which method is most effective for teaching the kettlebell swing: verbal cueing, physical constraints, or a combination of the two.

There is a method of teaching and learning movement and exercise skills known as the constraint-led approach. This method of movement learning has the learner exploring and experimenting different variations of an exercise by self-organizing around a set of given constraints of the individual, environment and task. Individual constraints are qualities about the person performing the task such as their arm length and height. Environmental constraints regard the environment where the task is being performed and include factors such as lighting and temperature. Finally, the task constraints are qualities about the movement and exercises being performed such as asking someone to do a half squat onto a box instead of a full bodyweight squat in the air. This constraints way of teaching movement has the movement educator as a guide or architect that shapes the qualities of the task the learner must navigate.

The kettlebell swing was chosen as the primary exercise for this study due to its efficacy and practicality as a functional movement pattern. Current literature suggests that kettlebell swings may elicit an increase in strength measured in the form of a deadlift exercise, which may have carry over to activities of daily living, such as bending over to lift a box with proper form. In a 2016 study, Edinborough et al. examined the proposed implications that repeated kettlebell swings could be used as a practical tool to increase endurance capacity of the lumbar extensor complex. The investigators of this study found that after a 60 second bout of continuous kettlebell swings, participants demonstrated a reduction in isometric strength, demonstrating fatigue of this musculature. The implications of this study suggest that kettlebell swings may increase the fatigue threshold of the lumbar extensor musculature, which may provide protective measures regarding the development of musculoskeletal conditions such as low back pain, as a decrease in activation of these associated muscles may be apparent during periods of fatigue.

Eligibility Criteria:
Inclusion Criteria:

* Subjects between the ages of 18 and 55 years.
* Subjective rating of 3/5 or less on confidence with kettlebell swings.

Exclusion Criteria:

* Inability to read and write in English.
* Previous injury to the lower extremity that prevents normal squatting motion.
* Physical Activity Readiness Questionnaire suggesting inability to safely participate in exercise.