cyrilzakka/clinical-trials huggingface dataset:
Study to Assess the Safety of BAY1067197 in Stable Heart Failure Patients on Standard Therapy Including ß-blocker

This is a study to investigate the safety and tolerability of the partial A1 agonist BAY1067197 in patients with chronic heart failure. BAY1067197 will be applied as a single dose of 30 mg in addition to standard therapy including a beta-blocker. The aim of the study is to assess if a single oral dose of 30 mg BAY1067197 is well tolerated when given on top of standard therapy for heart failure, particularly ß-blocker treatment.


Eligibility Criteria:
Inclusion Criteria:

* Stable systolic heart failure (heart failure with reduced ejection fraction, heart failure with reduced ejection fraction \[HFrEF\]; New York Heart Association \[NYHA\] I-III) in sinus rhythm with a documented ejection fraction (EF) ≤45% within the last 3 months
* Stable standard heart failure (HF) therapy including intermediate to high dose β-blocker with either ≥ 95 mg metoprolol succinate (controlled release tablet), ≥ 5mg Bisoprolol (immediate release \[IR\] -tablet) or ≥5mg Nebivolol (IR tablet) for at least 4 weeks. Additional intake of angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers and optional aldosterone-receptor antagonists, diuretics or digitalis is allowed
* Men or confirmed postmenopausal women (defined as being amenorrheic for longer than 2 years with an appropriate clinical profile, e.g. age appropriate and a history of vasomotor symptoms) or women without childbearing potential based on surgical treatment such as bilateral tubal ligation, bilateral ovarectomy, or hysterectomy (documented by medical report verification). Men enrolled in this study must agree to use adequate barrier birth control measures during the treatment period of the study and for 12 weeks after receiving the investigational medicinal product (IMP)
* Male patients must agree not to act as sperm donor for 12 weeks after dosing
* Ethnicity: White
* Body mass index (BMI): above/equal 18.0 and below/equal 29.9 kg/m²
* Age: 18 to 75 years (inclusive) at the first screening visit

Exclusion Criteria:

* Biventricular pacing/active cardiac resynchronization therapy (CRT) device
* Dependency on pacemaker or implantable cardioverter-defibrillator (ICD) device with pacemaker dependency (a paced ventricular rhythm \> 5% of heart activity)
* A history of relevant diseases of vital organs other than the heart, of the central nervous system or other organs
* Known hypersensitivity to the study preparations (active substances or excipients of the preparations) or to any other β-blocker
* Current or history of AV-Block \> I°
* Unstable condition, indicated by requirement of IV drug (diuretic, inotrope, etc.) or NYHA IV
* Acute Coronary Syndrome (defined as unstable angina \[UA\], non-ST elevation myocardial infarction \[NSTEMI\], ST elevation myocardial infarction \[STEMI\]) within 3 months prior to first study drug administration
* History of asthma or chronic obstructive pulmonary disease (COPD) ≥ global initiative for chronic obstructive lung disease (GOLD) II and/or allergic asthma
* Women of childbearing potential, pregnancy or breastfeeding
Effects of Oxytocin on Bleeding Outcomes During Dilation and Evacuation

Currently, there is very little research to identify ways to decrease blood loss during D\&E (dilation and evacuation) procedures. The objective is to determine whether routine use of intravenous oxytocin will improve bleeding outcomes at the time of D\&E at 18-24-weeks gestation. To evaluate the hypothesis, investigators will perform a randomized, double-blinded, placebo-controlled trial. The patient will be followed until discharged from the postoperative care unit during which time patient satisfaction, pain score and postoperative bleeding will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Requesting pregnancy termination
* Intrauterine pregnancy at 18- to 24-weeks gestation
* Gestational-age to be confirmed by ultrasound
* Patients with fetal anomaly or intrauterine fetal demise that occurred at 18- to 24-weeks gestation
* Willing and able to understand and sign written informed consents in English or Spanish and comply with study procedures

Exclusion Criteria:

* Ultrasound findings suggestive of placenta accreta
* Patients requiring preoperative misoprostol
Dexmedetomidine Versus Triamcinolone Treatment in Carpal Tunnel Syndrome

Carpal tunnel syndrome (CTS) is a common mononeuropathy due to entrapment of the median nerve in the carpal tunnel. a lot of modalities are available for treatment of mild to moderate CTS.

Carpal tunnel syndrome (CTS) is a common mononeuropathy due to entrapment of the median nerve in the carpal tunnel. a lot of modaleties are available for treatment of mild to moderate CTS.

In case of failed conservative oral therapey, local hydro-dessction of the median nerve can be done with saline alone. local anethetics, steroids, hyalase,and ozone have been utilized to augment the symptoms reliefe.

Dexmeditomidine (DEX) has been studied as adjuvant for nerve block to aumnet the pain reliefe. Recently, it has been discovered that DEX can offer some antinflammatory effects when injected in the perineural area. Upon such discovery, the goal of this study has been built.

Eligibility Criteria:
Inclusion Criteria:

* adult patients
* complaining of carpal tunnel syndrome of 3 month duration or more
* diagnosed axonal neuropathy using electrodiagnosis , nerve conduction study

Exclusion Criteria:

* patient refusal
* infection at the site of intervention
* allergy to utilized drugs
* diabetic
* previous surgery in the site of injection
* previous injection in the targeted site within the last year
Are Elastic Restraints Still Necessary in Improved Rehabilitation Programs After Hip and Knee Prosthetic Surgery?

Venous thrombosis and pulmonary embolism are considered serious and potentially preventable complications of hip and knee replacement surgery. The risks of thrombosis must be weighed against the risks associated with preventive measures, both mechanical and pharmacological. Modern medicine is now questioning the use of elastic restraints in surgery. Several studies have investigated the benefits of using restraints to prevent thromboembolic events. These studies have shown no additional benefit from the use of compression stockings in thromboembolism prevention. To the best of our knowledge, no orthopedic study has investigated the non-inferiority of pharmacological treatment compared with elastic compression devices, specifically in knee and hip surgery. The aim of this multicenter, prospective, randomized study is to investigate whether pharmacological prophylaxis alone is non-inferior to pharmacological and mechanical prophylaxis (using restraints) of peripheral venous thrombosis or pulmonary embolism up to 90 days after prosthetic surgery.


Eligibility Criteria:
Inclusion Criteria:

* first line and non-traumatic total hip or knee arthroplasty
* Patient included in an Enhanced Rehabilitation after Surgery (ERS) or "fast-track" protocol, or scheduled as an outpatient.

Exclusion Criteria:

* Patient requiring long-term anticoagulation for pre-existing co-morbidity
* Patients with coagulation disorders (hypercoagulability)
* Patient undergoing thrombogenic pharmacological treatment
* History of obliterative arteriopathy of the lower limbs
* Arterial disease
* Obesity
* Heart failure
* Chronic bronchopneumopathy
* Lymphedema
* Chronic inflammatory disease
* Permanent wearing of elastic restraints
* Proximal or distal arterial bypass surgery
* Creatinine clearance \< 15 ml/min
* Inability to give consent
* Revision surgery for hip or knee prosthesis
* Metastatic cancer
* Life expectancy less than 3 months
* Allergy to socks or compression stockings
* Patients presenting one or more exclusion criteria for the fast-track protocol (severe or poorly-balanced associated conditions such as diabetes or immunodepression, inability to contact the doctor or hospital department if necessary, pre-operative ASA score greater than or equal to 4).
* Adults under guardianship or curatorship
* Vulnerable persons in accordance with article L1121-6 of the CSP (French Public Health Code)
Cardiac Changes in Myeloproliferative Neoplasms

Myeloproliferative neoplasms are heterogeneous group of clonal hematopoietic stem cell neoplasms with excessive proliferation of one or more of the erythroid, megakaryocytic, or myeloid lineages and relatively normal maturation resulting in increased numbers of red cells, platelets, and/or granulocytes in the peripheral blood. Constitutive tyrosine kinase activation appears to be a common pathogenetic mechanism.

According to worldwide study of prevalence of myeloproliferative neoplasms revealed:

Incidence of polycythemia vera ranged 0.01 to 2.61 per 100.000 population and the prevalence ranging from 0.49 to 46.88 per 100.000 population. Incidence of essential thrombocythemia is 0.21 to 2.27 per 100.000 population, prevalence ranging between 11.00 - 42.51 per 100.000 population.

Primary myelofibrosis incidence is 1.15 -4.99 per 100.000 population and prevalence ranging between 1.76 - 4.05 per 100.000 population.In previous studies, cardiac involvement including coronary arterial thrombosis, myocardial infarction, pulmonary hypertension, asymptomatic pericardial effusion, cardiac tamponade, intractable cardiac failure due to intraventricular stenosis and valvular stenosis that occur in myeloproliferative neoplasms. There is a few number of studies in which cardiac lesions were evaluated in myeloproliferative neoplasms by using transthoracic echocardiography but still inadequate, so we need to understand more about cardiovascular complications in myeloproliferative neoplasms.

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic criteria of myeloproliferative neoplasms.

Exclusion Criteria:

* Extreme body weight e.g., morbid obesity.
* Cardiac disease.
* Cerebrovascular disorders.
* Diabetes mellitus.
* Dyslipidemia.
Safety and Tolerability Study With VY-HTT01, in Adults With Early Manifesting Huntington's Disease

This is the first clinical study of VY-HTT01, a gene therapy for early-stage Huntington's Disease (HD) patients. The primary goal of this trial is to evaluate the safety and tolerability of VY-HTT01. This study is a first in human study, Phase 1b, open-label, randomized, multicenter, dose escalation study with a delayed treatment control arm.

This dose escalation trial will evaluate the safety and tolerability of 4 single dose levels of VY-HTT01. The maximum duration that a subject randomized to treatment may be involved in the study is up to 15 months. Delayed treatment subjects will be followed for a minimum of 6 months as a control before moving up into the treatment arm in the next cohort. The maximum duration that a delayed treatment subject may be involved in the study is up to 24 months. Subjects who participate in this study will be asked to enroll in a long-term observation study.

Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 years old.
* Have CAGn repeat \>39.
* Have diagnostic confidence score of 4 based on motor, cognitive, or behavioral symptoms.
* Have a TFC score of 13 to 11.
* Have stable dosing of neurological and psychiatric medications.
* Capable of giving informed consent.
* Able to comply with all procedures and study visits.

Exclusion Criteria:

* Have any significant structural or degenerative neurologic disease other than HD.
* Have any chronic disability, significant systemic illness and/or, unstable medical condition, or clinical findings noted.
* Have primary or secondary immune-compromise due to infections or medical conditions or chronic therapies.
* Have contraindications to lumbar puncture or increased risks of bleeding upon surgery.
* Started or changed dose of a concomitant CNS medication within 30 days.
* Had prior neurosurgical procedures that could complicate the study procedures.
* Have used any investigational therapies within 30 days prior to Screening, oligonucleotide therapies within 9 months prior to Baseline, or any prior gene therapy.
* Male or female with reproductive capacity and is unwilling to use highly effective contraception for 12 months after surgery.
* Have contraindications to MRI such as claustrophobia, embedded metal in the body, or known allergy or intolerance to contrast agents.
Systematically Assessing Effects of Colored Light on Humans With a Multi-modal Approach (Substudy 2 of 7)

NOTE: This is the second of in total 7 sub-studies related to the Ethics Committee of the Canton of Bern Ref. No. KEK-BE 2016-00674. This sub-study includes 50 participants and 6 arms, in total 350 participants will be assessed in all 7 sub-studies.

General study information: This is a randomized, cross-over, quantitative study, which investigates physiological variables, mood, and affect of healthy participants in response to colored light exposure. The Participants take part in 5-8 arms and are exposed to colored light only, or are additionally asked to solve cognitive tasks during the colored light exposure. Primary aim is to measure the change in several physiological variables, mood, and affect during colored light exposure of 15 or 45 minutes. The risk for the participants is negligible and comparable to the risk during daily life.


Eligibility Criteria:
Inclusion Criteria:

* Normal color vision
* Right handed
* Written informed consent

Exclusion Criteria:

* Smoking
* Any kind of diagnosed sleep disorder or neurological or psychiatric disorder in the last 3 months
* Acute severe traumas
* Chronic diseases with the necessity for medication
* Use of recreational drugs
* Regular intake of medication that would affect the outcome measures
* Regular excessive alcohol use (\> 18 standard units / week)
* Transmeridian travel in the last month (crossed \> 1 time zone border)
* Night shift word during the last month
Safety, Tolerability and PK Study of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD.

2-week open-label safety, tolerability and pharmacokinetic study of methylphenidate HCl ERCT in 4-5 year old children with ADHD.

Phase 4, Open-label, Safety, Tolerability And Pharmacokinetic Study Of methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablets (ERCT) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (ADHD)

Eligibility Criteria:
Inclusion Criteria:

1. Male or female child 4-5 years of age at screening.
2. Signed and dated informed consent provided by the subject's parent/legal and assent of the child (as applicable)
3. Meets DSM-5 criteria for ADHD based on the K-SADS-PL.
4. ADHD RS-IV Preschool-Home Version score at Screening and Baseline \>/= 90th percentile for gender and age in \>/=1 of the following: hyperactive-impulsive subscale, inattentive subscale, or total score.
5. Peabody Picture Vocabulary Test 4 (PPVT-4)Standard Score \>/=70.
6. Child Global Assessment Scale (CGAS) score \</= 55.
7. History of an adequate course of non medication treatment for ADHD based on investigator judgment or, where such treatments are not available, the severity of the subject's ADHD symptoms are such that medication treatment is deemed necessary by the investigator.

Exclusion Criteria:

1. Treated with atomoxetine within 30 days prior to the Baseline.
2. Received any investigational products or devices within 30 days prior to the Baseline visit.
3. History of stimulant nonresponse, intolerability or hypersensitivity to any dose of methylphenidate or other stimulant.If a subject has a known allergy to D\&C red #30, he/she should not be enrolled in the study.
4. An intelligence quotient (IQ) \<70.
5. History of acute or chronic medical or psychiatric condition or cardiac or laboratory abnormality.
6. Less than 5th percentile for height or weight at Screening.
7. History of recent clinically significant self-harming behaviors.
OPV as Potential Protection Against COVID-19

Since the 1960s, studies have shown that oral polio vaccine (OPV) may have beneficial non-specific effects, reducing morbidity and mortality from other infections than polio. Such beneficial non-specific effect have been observed for other live vaccines, including measles, smallpox and BCG vaccine. For BCG, the vaccine for which the mechanism has been studied the most, the effects appear to be mediated through the innate immune system. The COVID-19 pandemic caused by the novel coronavirus SARS-CoV-2 has now caused over 7.1 million cases and \>400,000 deaths worldwide. As everywhere else, it is anticipated that in Africa the older part of the population will be at risk of severe COVID-19. OPV is widely used in Africa, but for children. Both polio and coronavirus are positive-strand RNA viruses, therefore it is likely that they may induce and be affected by common innate immune mechanisms.

In a randomised trial at the Bandim Health Project in Guinea-Bissau, the investigators will assess the effect of providing OPV vs no vaccine to 3400 persons above 50 years of age. The trial will have the power to test the hypothesis that OPV reduces the combined risk of morbidity admission or death (composite outcome) by at least 28% over the subsequent 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Living in a household which has had a census visit conducted after 1 January in 2017. Age above 50.

Exclusion Criteria:

* Previous adverse events to OPV; Previous documented COVID-19; Acute severe infection.
Diurnal Variability in the Regulation of Beta-cell Function and Insulin Sensitivity in Overweight People

The purpose of this research study is to learn more about how our body produces sugar, breaks down fat for fuel, and makes insulin (the major hormone that controls the production of blood sugar and fat breakdown) during a 24-hour day and how body fat and muscle are involved in these processes.

The purpose of this study is to determine whether there are diurnal differences in postprandial beta-cell function and hepatic insulin sensitivity and the factors that influence these metabolic functions, including insulin signaling, adipose tissue and systemic inflammation, nicotinamide phosphoribosyltransferase (NAMPT)-mediated nicotinamide adenine dinucleotide(NAD) biosynthesis, and sirtuin (silent mating type information regulation 2 homolog 1 (SIRT1)) in overweight human subjects.

Eligibility Criteria:
Inclusion Criteria:

* Females
* 18-55 years old
* BMI between 25.0-29.9 kg/m2
* Must be sedentary (regular exercise \<1hour/week or \<2 times/week

Exclusion Criteria:

* Regular exercise (\>1hour/week or \>2 times/week)
* Diabetes
* Severe organ dysfunction
* Smokers
* Severe hypertriglyceridemia (\>300 mg/dl)
* Medications that may alter the results of the study
* Pregnant
* Breastfeeding
Radiation-Free Heart Catheterization Using MRI

Currently catheters used in heart catheterization procedures are guided throughout the heart chambers and blood vessels by pictures taken by x-rays. This technology exposes patients to radiation. With this study protocol the investigators will use MRI technology to take real-time pictures to navigate catheters throughout heart chambers. MRI uses electromagnetic energy; therefore, it does not expose participants to radiation energy.

Participants undergo general anesthesia, and vascular access is obtained in the x-ray catheterization lab. Next the participant is transferred into the MRI scanner where a focused MRI examination is performed. Catheters are then guided into the heart chambers using real-time MRI guidance to perform conventional cardiac catheterization steps. If time allows, additional research MRI is performed before the participant is returned to the x-ray catheterization lab. If any MRI guided catheterization steps are unsuccessful, the clinically indicated step is performed after the participant returns to the x-ray catheterization lab using conventional x-ray guided pictures.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing a medically necessary cardiovascular catheterization

Exclusion Criteria:

* Cardiovascular instability including hemodynamic instability (such as requiring significant vasoactive infusion support) or mechanical hemodynamic support.
* Women who are pregnant
* Women who are nursing and who do not plan to discard breast milk for 24 hours
* Patients with a contraindication to MRI scanning will be excluded. These contraindications include patients with the following devices:

  1. Central nervous system aneurysm clips
  2. Implanted neural stimulator
  3. Implanted cardiac pacemaker or defibrillator which are not MR safe or MR conditional according to the manufacturer
  4. Cochlear implant
  5. Ocular foreign body (e.g. metal shavings)
  6. Implanted Insulin pump
  7. Metal shrapnel or bullet

Exclusion criteria for Gadolinium (contrast agent)

1. Renal disease with estimated glomerular filtration rate \< 30 ml/min/1.73 m2 body surface area
The Effect of Interpersonal Psychotherapy on Quality of Life Among People Living With HIVAIDS

Quality of life (QOL) is a significant importance for people living with HIV/AIDS by modifying the adverse psychosocial consequences that accompany the disease. In Ethiopia, interpersonal psychotherapy (IPT) has never been tried for people living with HIV/AIDS for quality of life. The objective of the study was to assess the effects of interpersonal psychotherapy on quality of life among PLWHA at Mettu Karl referral and Bedele hospital, southwest Ethiopia, 2022.


Eligibility Criteria:
Inclusion Criteria:

* PLWHA who were 18 years of age or above were included in the study

Exclusion Criteria:

* PLWHA who are either currently or previously used IPT and acute physical or mental disturbances will be excluded
Internal Jugular Vein Distensibility and Pleth Variability Index(PVI) for Evaluating Fluid Responsiveness

Assessment of intravascular volume status is crucial in order to predict the efficacy of volume status in major abdominal surgery. The aim of the study is to verify the feasibility and usefulness of the internal jugular vein distensibility index as an adjunct to the pleth variebility index(PVI) to predict fluid responsiveness in major abdominal surgery.

Forty patients above age 18 and ASA status I-III who are undergoing major abdominal surgery will be enrolled in the study. patients with right heart failure, arrythmia, severe valve stenosis or regurgitation will be excluded. After induction of general anesthesia, when the patients are hemodynamically stabilised, PVI and jugular vein distensibility will be calculated and recorded. after volume load with 500 ml gel infusion(in 15 min), measurements will be repeated within 10 minutes and recorded. Patients will be allocated to 2 groups according to the change in mean arterial pressure(MAP) after volume expansion: Responders will be defined as an increase in MAP by \>%10; while nonresponders will be defined as an increase in MAP \<%10 or decrease in MAP.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists(ASA) physical status I-III patients
* patients undergoing major abdominal surgery

Exclusion Criteria:

* arrythmia
* severe right ventricle failure
Oral Iron Frequency for Childhood Restless Leg Syndrome/Periodic Limb Movement Disorder

The purpose of this research study is to see if the level of serum ferritin differs based on how often oral iron (in the form of ferrous sulfate) is given to children with restless leg syndrome/periodic limb movement disorder.


Eligibility Criteria:
Inclusion Criteria:

* Ferritin equal to or lower than 24 mcg/L drawn within the last 30 days.
* Age 2 to 10 years.
* Diagnosis of restless leg syndrome, periodic limb movement disorder, or sleep disturbance.

Exclusion Criteria:

* Currently taking oral formulation of iron other than a multivitamin.
* Untreated obstructive sleep apnea.
* Gastrointestinal disorder, including gastroesophageal reflux disease and celiac disease.
* Prior gastrointestinal surgery; e.g., gastrectomy, duodenal bypass, and presence of G-tube.
* Use of H2 blocker, antacid, or proton pump inhibitor.
* Inflammatory disorders, including juvenile idiopathic arthritis or inflammatory bowel disease.
* Elevated CRP at time of initial ferritin or report of illness in past 4 weeks.