cyrilzakka/clinical-trials huggingface dataset:
VK2735 for Weight Management Phase 2 (Venture Oral Dosing)

This is a phase 2, 13-week randomized, double-blind, placebo-controlled, parallel arm dose-finding study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of VK2735 Oral Formulation in adults who are obese (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with at least one weight-related co-morbid condition.

VK2735 or matched placebo will be administered once daily.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years of age at the time of signing the informed consent.
2. Body mass index (BMI) ≥30 kg/m2 OR ≥27 kg/m2 with at least one weight-related co-morbid condition (treated or untreated), and BMI \<50 kg/m2

   * Weight-related co-morbid conditions include hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease.
   * BMI calculated at the Screening visit will be used to determine eligibility.

Exclusion Criteria:

1. History of or current clinically significant medical or psychiatric disorder that, in the opinion of the Investigator, does not support study participation
2. Self-reported body weight change of 5% or more within 3 months of screening
3. Current or past diagnosis of diabetes mellitus (including type 1, type 2, gestational)
4. Current or past diagnosis of chronic pancreatitis
5. Calcitonin ≥50 ng/L measured by central laboratory at screening (individuals with elevated calcitonin at initial screening may be re-screened)
6. Any GLP-1 receptor agonist or GLP-1/GIP dual agonist within 6 months of Screening
7. Any prescription or over-the-counter medications intended for weight loss within 6 months of screening
Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2023/24

This EPSS will determine the vaccinee reporting rates (RRs) of suspected ADRs following routine vaccination with VaxigripTetra® and Efluelda® respectively, during the NH influenza season 2023/24. The primary objective of this surveillance is to estimate the vaccinee reporting rate (RR) of suspected adverse drug reactions (ADRs) occurring within 7 days following routine vaccination with VaxigripTetra® and Efluelda® respectively, during the Northern Hemisphere (NH) influenza season 2023/24. Study duration per participant 2 months (including 6 weeks for VC distribution 2 weeks for vaccinee reporting) following the first vaccination


Eligibility Criteria:
Inclusion Criteria:

There are no formal inclusion criteria. Individuals who approach the site for vaccination and agree to receive a vaccination card will be included and vaccinated with the respective vaccine brand according to the country of their location, recommendations for the individual vaccines as well as national recommendations

Exclusion Criteria:

-
STITCH2 (Simplified Therapeutic Intervention to Control Hypertension and Hypercholesterolemia)

The objective of this study is to assess if the implementation of a treatment algorithm including initial treatment with a low dose diuretic/ACE-inhibitor or ARB combination and subsequently a low dose DHP-CCB/statin combination will improve the management of hypertension/hypercholesterolemia compared to guidelines-base management at family practices.

Utilization of fixed dose combination therapy has been advocated as an adherence-enhancing strategy and has been so recommended in the 2007 Canadian Hypertension Education Program (CHEP) recommendations. Further, in a previous study (STITCH) it was demonstrated that a simplified treatment algorithm utilizing initial therapy with a low dose fixed-dose combination therapy improved blood pressure control in hypertensive patients. However, the effectiveness of either a simplified treatment algorithm or the initial use of fixed dose combination therapies for 2 risk factors in hypertensive dyslipidemic patients has yet to be determined. Therefore, the current study is designed to determine whether utilization of a fixed dose combination hypertension/hypercholesterolemia therapy results in improved adherence, patient satisfaction as well as improved rates of reaching target LDL cholesterol and blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* male or female subjects 18 years or older
* documented diagnoses of hypertension and of hypercholesterolemia or current therapy for these conditions
* uncontrolled hypertension (SBP \>140 mmHg or DBP \>90 mmHg) or cholesterol levels above their threshold based on their global atherosclerotic risk profile (based on ATP III assessment)
* ability to give written informed consent

Exclusion Criteria:

* ischemic heart disease, atrial fibrillation, chronic kidney disease and significant liver disease
* currently prescribed 3 or more drugs to control blood pressure
* currently prescribed 2 or more drugs to control hypercholesterolemia
* participating in other hypertension/hypercholesterolemia studies
Shifting Sleep Timing in Teens

The goal of this clinical trial is to determine whether a combination of a novel lighting intervention and a behavioral intervention are able to increase total sleep time in adolescents. The main questions this trial aims to answer are whether this combination therapy is able to meaningfully increase total sleep time in adolescents, and do so over a sustained period of time, and whether such a changes is associated with concomitant changes in mood and cognitive performance.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 14-18 and a full-time student in grades 9-12
2. Male or female
3. Willing and with a schedule permitting them to go to bed at an earlier time
4. Planning on sleeping at home in their bedroom for at least 75% of the study

Exclusion Criteria:

1. Currently taking any medications (including over-the-counter medications, e.g., melatonin) specifically for the treatment of sleep disorders
2. Sleep only in the prone (face-down) position
Safety, Tolerability, PK, and Pharmacodynamics(PD) of IONIS APOCIII-LRx in Healthy Volunteers With Elevated Triglycerides

The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IONIS APOC-III-LRx given to healthy volunteer subjects.


Eligibility Criteria:
Inclusion Criteria:

* Must have given written informed consent and be able to comply with all study requirements
* Healthy males or females aged 18-65 inclusive
* Females must be non-pregnant and non-lactating, and either surgically sterile or post- menopausal
* Males must be surgically sterile, abstinent or using an acceptable contraceptive method
* BMI \< 35.0 kg/m2
* Subjects must have Fasting TG ≥ 90 mg/dL or ≥ 200 mg/dL depending on Cohort assignment

Exclusion Criteria:

* Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B
* Treatment with another Study Drug, biological agent, or device within one-month of screening
* Regular excessive use of alcohol within 6 months of Screening
* Use of concomitant drugs unless authorized by the Sponsor Medical Monitor
* Smoking \> 10 cigarettes a day
* Considered unsuitable for inclusion by the Principal Investigator
Real Life Effectiveness in Patients With Not Optimally Controlled Asthma

In real life, the investigators will be using different strategies including SMART therapy or other ICS/LABA (medium and high dose) therapy and measure the efficacy for asthma control.

1. All not-well controlled asthma patients would include the study.
2. We will compare three ways of asthma control including SMART, fixed doses with regular doses and fixed doses with higher doses
3. We will evaluate the efficacy/safety for these not-well controlled patients.

Eligibility Criteria:
Inclusion Criteria:

* asthma not well control

Exclusion Criteria:

* COPD
Thyroid Hormones in ADPKD

Autosomal dominant polycystic kidney disease (ADPKD) is a monogenic, rare and life-threatening disease, characterized by the pathological formation of multiple fluid-filled cysts that arise from renal tubules and alter kidney architecture and function. In most patients, the progressive deterioration of renal function ultimately leads to end-stage kidney disease (ESKD) and the need for dialysis or kidney transplantation.

Save the conventional anti-hypertensive strategies, there are currently two disease-specific treatments for ADPKD (Tolvaptan and Octreotide-LAR). However, these drugs are only available to patients at high risk of progression to ESKD, while a remarkable number of ADPKD patients progress to ESKD despite the treatments.

Cyst formation in ADPKD is determined by mutations in two genes encoding two transmembrane proteins: polycystin1 and polycystin2. The pathogenesis of the disease involves a series of phenotypic alterations, including the de-differentiation of epithelial cells, uncontrolled proliferation and abnormal secretion of fluids in the cysts, metabolic remodeling, all phenomena that lead to the progressive loss of renal structure and function . Therefore, to try to investigate the mechanisms of the disease, the investigators should go in search of pleiotropic molecules capable of simultaneously modulating structure, function and metabolism.

Research done so far suggests that thyroid hormones (TH) may also act as pleiotropic modulators in the patho-biology of ADPKD. TH signals play a crucial role in the regulation of cell de-differentiation and cell cycle reactivation, as well as in the metabolism and evolution of cardiac and renal diseases. Interestingly, changes in TH levels have been detected in approximately 80% of patients with chronic renal failure (CKD), whereas patients with ADPKD show a higher incidence of clinical and subclinical hypothyroidism. Despite these evidences, the ability of TH to modulate anti-cystogenic and renoprotective processes in ADPKD has not yet been studied.

The objective of this study is to determine the levels of THs in the serum of ADPKD patients with normal renal function and mild, moderate or severe renal dysfunction, and to correlate them with renal functional parameters.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female ≥18 years old;
2. Diagnosis of ADPKD based on renal ultrasonography or genetic test;
3. Written informed consent

Exclusion Criteria:

1. Diagnosis of Hashimoto's disease, hyperthyroidism or pituitary disease or any other condition undergoing levothyroxine replacement
2. Patient with hypothyroidism treated with drug therapy
3. Active treatment with Tolvaptan and/or Octreotide-LAR;
4. Regular treatment with amiodarone, lithium, interferon or immunosuppressive drugs including steroids;
5. Active malignancy or acute or chronic inflammatory disease, HIV;
6. Dialysis or kidney transplantation;
7. Diabetes mellitus;
8. Hypocaloric diet or current dietary approaches to obtain weight loss.
9. Legal incapacity or any evidence that the patient will not be able to understand the study aims and procedures.
Web-based Intervention for Disaster-Affected Youth and Families

A single disaster, terrorist attack, or other large-scale incident can adversely affect thousands of youth and families. Immediate consequences may include unmet basic needs and high economic burden, particularly among underserved populations. Disasters also can dramatically affect family roles and relationships over time (e.g., family routines, marital stress, parent-child interactions). Whereas most youth are resilient in the aftermath of disasters (i.e., do not develop serious mental health or health-risk problems), the prevalence of various problems of public health significance (e.g., PTSD, depression, substance abuse) clearly increases in this population. This underscores the need for effective, widely accessible, culturally-appropriate and cost-efficient interventions that foster resilience or rapid recovery relative to the health effects of disasters. Yet, few evidence-informed resources are available to youth and families to facilitate post-disaster resilience and recovery. Primary aims of this project are: (a) to develop a Web-based intervention for disaster-affected adolescents and parents targeting prevalent health-related correlates of disasters (i.e., development phase), (b) to conduct a randomized controlled population-based study to examine feasibility and preliminary efficacy of the intervention (i.e., randomized controlled trial \[RCT\] phase) and cultural relevance (i.e., perceived applicability of the intervention to one's cultural group), and (c) to refine the intervention based on RCT-phase data.


Eligibility Criteria:
Inclusion Criteria:

* adolescent between the ages of 12-17 and primary caregiver,
* residence in study identified location(s) at time of disaster,
* home internet connectivity

Exclusion Criteria:

* adolescent's primary caregiver not available,
* no adolescents in home,
* not residing in location at time of disaster,
* poor or no internet connectivity
Automated Caries Detection Using a 3D Intraoral Scanner. An in Vivo Validation Study.

This in vivo study with in vitro validation assessed four different algorithms (ALG1-ALG4) implemented in the intraoral scanner system for automated caries detection and classification. 3D scans of the examined teeth were obtained both in vivo and vitro, i.e. before and after tooth extraction, in order to assess any possible differences in the performance of the algorithms at different conditions. The latter could potentially help drawing some conclusions regarding i) the validity of the in vitro studies assessing fluorescence method for caries detection, and ii) the in vivo applicability of in vitro results obtained in the past and the future. Additionally, visual-tactile examination using the ICDAS (ICDAS II) criteria19 was conducted on the same teeth in vivo and histological assessment was used as reference test in vitro.


Eligibility Criteria:
Inclusion Criteria:

* Patients with permanent molars / premolars,
* Sound teeth or with caries lesions on the occlusal surfaces.

Exclusion Criteria:

* Front teeth / deciduous teeth
* Teeth with fillings
* Teeth with broken crown
* Teeth with extensive lesions on the lateral surfaces.
The Study to Assess AMI Treated With Balloon Angioplasty.

The main objective of this study is to assess the effectiveness and safety of the CYPHER™ (CYPHER SELECT™) (Sirolimus-eluting) stent in reducing the occurrence of a composite endpoint of target vessel failure (TVF) in subjects treated for acute myocardial infarction as compared to a bare metal stent.

This is an international, multicenter (up to 52 sites), randomized, single-blind study in patients with an acute myocardial infarction treated with the CYPHER™ (Sirolimus-eluting) stent as compared to the bare stents.

Patients with de novo native coronary artery lesions will be treated with the CYPHER™ (Sirolimus-eluting) stent or a bare stent. Subjects will be followed at 30 days, 6 months and at 1, 3, 4 and 5 years post-procedure. 200 subjects will have an angiographic follow-up at 8 months.

Eligibility Criteria:
Inclusion Criteria:

1. Have prolonged, continuous (lasting at least 20 minutes) chest pain despite administration of nitrates and onset within 12 hours of randomization, and one of the following:

   1. ST segment elevation \>=1mm in standard leads and \>=2mm in 2 or more contiguous precordial leads with reciprocal ST depression
   2. New or presumably new left bundle branch block (LBBB)
2. The culprit lesion must be identified on a de novo native coronary artery and an emergency angioplasty must be possible. The culprit site must be visualized before the stent implantation;

Exclusion Criteria:

1. Killip class \> 2 upon arrival to the cath-lab;
2. Significant (\>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede inflow or runoff;
3. Evidence of massive thrombus in the infarct related artery distally to the culprit lesion;
4. Documented left ventricular ejection fraction \<=30%;
5. Target lesion is located in an arterial or venous by-pass graft;
6. ECG documented evidence of prior myocardial infarction;
7. Patient who received thrombolytic therapy for the current AMI before enrollment in this study.
Bioequivalence Study of Metformin 1000 mg Tablets Immediate Release (IR) Versus Glucophage® 1000 mg Tablets IR In Healthy Subjects

Bioequivalence Study of 2 formulation of metformin (Metformin GEROPHARM vers. Glucophage® Merck )

Study to evaluate the bioequivalence of orally administered metformin preparations, immediate release tablets, 1 000 mg in normal healthy subjects under fasting and fed conditions

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form.
* Healthy male and female subjects aged 18 to 45 years.
* Verified diagnosis is "healthy" according to data Standard clinical, laboratory and Instrumental methods of examination.
* Have a body mass index between 18,5 and 27 kg/m2.
* Females must have a negative pregnancy test.
* Subjects must use, with their partner, methods of highly effective contraception throughout the study and 30 days after the end of study.

Exclusion Criteria:

* History of serious allergic problems/events
* Medicinal intolerance.
* History of allergic reactions to memantine or investigator's product components
* Any acute and chronic diseases of the cardiovascular system, cardiovascular, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract, liver, kidneys, blood.
* Acute infectious diseases in less than 4 weeks before the start of the study.
* Subjects who have taken medication 4 weeks preceding before the study.
* Subjects who have taken any drugs known effects on hemodynamics or to induce or inhibit hepatic drug metabolism within 30 days prior to administration of the study medication (examples of inducers: barbiturates, omeprazole, etc.).
* Donation of plasma (450 mL or more) within 2 month prior to administration of the study medication.
* History of significant alcohol or drugs abuse or any indication of the regular use of more than 10 units of alcohol per week (1 Unit = 200 mL of wine or 500 mL of beer or 50 mL of alcohol 40%).
* Smokers.
* Participation in other clinical training is less than than for 3 months before the study.
* Lack of signed informed consent form.
* ECG or vital signs abnormalities (clinically significant).
* Positive testing for alcohol, drugs, pregnancy.
* Dehydration due to diarrhea, vomiting, or other causes within the last 24 hours before the start of the study.
* Any diet, for example, vegetarian, for 2 weeks before taking the study medications.
* Women with preserved reproductive potential who have unprotected sexual intercourse with an unsterilized male partner within 30 days prior to taking the study medication.
* Heart rate below 60 or above 80 beats per minute.
* Systolic blood pressure less than 110 mm Hg or more than 139 mm Hg.
* Diastolic blood pressure less than 70 mm Hg or more than 89 mm Hg.
Exercise Effects on the Neurobiology Underlying Stress-related Eating Behaviors in Veterans

The purpose of this study is to learn more about how common lifestyle interventions, such as exercise, affect how our brains respond to performing thinking tasks and to viewing pictures of foods and various other objects. The investigators are also interested in how changes in hormones that might be different in men and women could affect how lifestyle interventions change these brain responses.

The purpose of this study is to learn more about how common lifestyle interventions, such as exercise, affect how our brains respond to performing thinking tasks and to viewing pictures of foods and various other objects. The investigators are also interested in how changes in hormones that might be different in men and women could affect how lifestyle interventions change these brain responses. This will help us to better understand how different lifestyle interventions affect the brain and how this might relate to various behaviors. Eligible participants will be asked to complete 2 study days before and again after a 12-week intervention period, during which they will either continue with usual activities or be asked to complete exercise sessions four times per week. They will be randomly assigned to one of these conditions (exercise or not) and will not be able to choose their group assignment.

Eligibility Criteria:
Inclusion Criteria:

* Veterans 18-75 years old
* BMI of 25 or greater
* Physically inactive
* Able to attend study visits in person in Aurora, CO

Exclusion Criteria:

* Currently pregnant
* History of bariatric surgery
* Contraindication to MRI (weight \> 500 lbs; claustrophobia; metal or electronic devices in the body)
* Unable to exercise due to cardiac, pulmonary, neurologic, or orthopedic reasons
* Unable to pass screening graded exercise treadmill test
Alzheimer's Disease Long-term Follow-up Study (ALF Study)

Open study for efficacy and safety of donepezil treatment during 48 weeks


Eligibility Criteria:
Inclusion criteria

* Men or women aged 40 to 90
* Diagnosis of dementia according to DSM-IV
* Diagnosis of probable AD as defined by NINCDS-ADRDA criteria
* Mild to moderate AD at baseline, as defined by MMSE score of 10 to 26
* Patients were generally healthy and ambulatory or ambulatory aided
* Patients did not take acetylcholinesterase inhibitor 4 weeks before screening
* Patients have useful MRI results 3 months before screening

Exclusion

* If they have evidence of TIA or major infarction
* Epilepsy patients
* If they have evidence of other degenerative or psychiatric disorder, other serious disorder, alcoholism or drug abuse
* If they sensitive to acetylcholinesterase
* If they taken concomitant medication which were not allowed
Disturbed Structural Connectivity of Frontostriatal and Frontoparietal Networks in Adults With ADHD

Attention deficit/hyperactivity disorder (ADHD) is a common, impairing, childhood onset neuropsychiatric disorder with executive dysfunctions. The ADHD symptoms and executive deficits may last to adulthood. Our previous studies, like western results, have shown that children with ADHD have disrupted microstructural integrity of frontostriatal fiber pathways and impaired brain activity in frontoparietal network. However, there is lack of data with regards to whether adults with ADHD also demonstrate structural and functional disconnectivity of frontostriatal and frontoparietal networks as compared to healthy controls without ADHD in Asian population and no study has been done to correlate a wide range of executive functions with the connectivity of these two networks.

Specific Aims:

1. to compare the executive functions, and structural and functional connectivity in frontostriatal and frontoparietal circuitries between adults with ADHD and healthy controls without ADHD;
2. to correlate the data from structural and functional connectivity, executive functions, and ADHD core symptoms stratifying by the ADHD and controls; and
3. to explore other circuitries that may involve in ADHD by using whole brain tractography analyses.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18-45, who have clinical diagnosis of a ADHD according to the DSM-IV criteria.

Exclusion Criteria:

* The subjects will be excluded from the study if they meet any of the following criteria: (1) Comorbidity with diagnoses of autism spectrum disorder, schizophrenia, schizoaffective disorder, delusional disorder, other psychotic disorder, organic psychosis, schizotypal personality disorder, bipolar disorder, depression, severe anxiety disorders or substance use; (2) With neurodegenerative disorder, epilepsy, involuntary movement disorder, congenital metabolic disorder, brain tumor, history of severe head trauma, and history of craniotomy; (3)With visual or hearing impairments, or motor disability which may influence the process of MRI assessment; and (4) Full-scale IQ lower than 80.