cyrilzakka/clinical-trials huggingface dataset:
An Assessment of the Effectiveness (Efficacy) of Odeston (Odeston®) in Patients With Chronic Cholecystitis in Real Medical Practice

Post-marketing Observational Clinical Study: Assessment of the Effectiveness (Efficacy) of Odeston (Odeston®) in Patients With Chronic Cholecystitis in Real Medical Practice


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 to 65 years;
* BMI 18.5 - 40;
* Verified diagnosis: chronic acalculous cholecystitis;
* Voluntary desire to provide informed consent to participate in the study

Exclusion Criteria:

* Presence of stones in the gall bladder and bile ducts;
* The presence of jaundice, cholestatic liver diseases, liver cirrhosis with decompensation;
* Increased ALT, AST above the 3 upper limits of normal;
* Hypersensitivity to the components of the drug Odeston;
* Pregnancy and lactation;
* Prolonged fasting and total parenteral nutrition;
* Patients with symptoms of acute abdomen at the time of inclusion in the study;
* Patients with symptoms of acute neurological pathology at the time of inclusion in the study and/or аcute cerebrovascular accident, a history of convulsive syndrome;
* Presence of cancer;
* Acute infectious diseases at the time of inclusion in the study;
* Fever of any origin (above 37.5 C);
* Patients with symptoms of heart failure;
* Patients with symptoms of pulmonary failure;
* Patients with symptoms of acute or chronic renal failure;
* A decompensated form of diabetes;
* Patients with signs of psychiatric disorders.
Plaque Inflammation and Dysfunctional HDL in AIM-HIGH

Coronary heart disease (CHD) is a serious health concern that affects millions of people in the United States. It is usually caused by atherosclerosis-a condition that occurs when fatty material and plaque build up on the walls of the arteries that supply blood and oxygen to the heart, causing the arteries to narrow. As the arteries narrow, blood flow to the heart can slow down or stop, which can cause chest pain, shortness of breath, heart attack, or heart failure. Another component of CHD events involves inflammatory changes that result in structural breakdown of atherosclerotic plaques. Adding niacin to statin medications may be an effective way to block inflammation in the atherosclerotic plaques. This study will examine magnetic resonance imaging (MRI) images and blood samples of participants in the AIM-HIGH study who are taking niacin plus statins or statins alone to determine the effect of these medications on inflammation in atherosclerotic plaques.

CHD is the leading cause of death in the United States. Preliminary research has shown that CHD is associated with oxidative and inflammatory changes in high-density lipoprotein (HDL) cholesterol, which is considered the "good" cholesterol. The inflammatory changes can impair HDL cholesterol's normal function, which is to remove excess cholesterol from the arteries and thereby slow the build-up of atherosclerotic plaque. Statins are cholesterol-lowering medications that are used to treat people with CHD. Taking niacin, a type of B vitamin, in combination with statins may stabilize atherosclerotic plaques better than statins alone, but more research is needed to examine how niacin may do this. By improving the ability of HDL cholesterol to repair inflammatory damage to atherosclerotic plaques, niacin may assist in preventing the inflammation that leads to plaque breakdown.

The AIM-HIGH study (NCT00120289) is examining the use of niacin plus statins in people with vascular disease. Participants in the AIM-HIGH study are randomly assigned to receive either niacin plus simvastatin, which is a type of statin medication, or simvastatin alone. The purpose of this substudy is to determine whether niacin in combination with statins reduces atherosclerotic plaque inflammation and dysfunctional HDL cholesterol more than statins alone. The substudy will enroll participants who are participating in the AIM-HIGH study. At the AIM-HIGH baseline and Year 2 study visits, study researchers for this substudy will collect an additional blood sample from participants to examine the changes in HDL oxidation levels and protein composition at both time points. Study researchers will also analyze participants' MRI scans to examine changes in plaque inflammation during the study period; these MRI scans will be completed as part of another AIM-HIGH substudy, conducted by Dr. Xue-Qiao Zhao. There will be no additional study procedures or visits for participants in this substudy.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for main AIM-HIGH study (NCT00120289)
* Willing to provide informed consent for participation in this substudy
Survey on Precision Medicine and Digital Health

The investigators have created an anonymous online survey that queries current topics in precision medicine.

The investigators have created an anonymous online survey to assess the educational requirements and current gaps in knowledge related to advances in precision medicine. These include questions that focus on digital health, wearable technologies, genetic sequencing, and CRISPR to assess survey participants' interest and knowledge level.

Eligibility Criteria:
Inclusion Criteria:

* Students and physicians at all levels of training.

Exclusion Criteria:

* None.
Efficacy of Respiratory Physiotherapy on Severe ICU-admitted COVID-19 Patients.

COVID-19 is an infectious disease caused by SARS-CoV2 virus. COVID-19 patients can develop a severe disease that can lead to hypoxic respiratory failure and acute respiratory distress syndrome (ARDS). Severe patients can require access to intensive care unit (ICU). Early rehabilitation is known to be effective in critically ill patients and in ARDS.

Early rehabilitation is known to be effective in critically ill subjects. The role of physiotherapy in severe COVID-19 patients is still unclear and few guidelines have been proposed so far. Aim of this study is to assess efficacy of early rehabilitation for severe ICU-admitted COVID-19 patients as compared to a group that did not received physiotherapy treatment in ICU.

COVID-19 is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which emerged in China in December 2019 and in Italy in February 2020. A large proportion of infected people have mild clinical manifestations, whereas \>10% develop a severe disease, which could evolve into acute hypoxemic respiratory failure (AHRF) and acute respiratory distress syndrome (ARDS) requiring intensive care unit (ICU) admission. A high proportion of ICU patients need invasive mechanical ventilation (IMV) and about 50% of the ICU-admitted patients die. The median age of ICU COVID-19 patients was \<65 years and the mortality in patients aged \<63 years ranges from 15 to 20%.

Early rehabilitation is safe and effective in critically ill patients and, in patients with ARDS, it helps to reduce the functional impairment due to the prolonged stay in ICU. Preliminary data suggest the implementation of early and active mobilization programs, as well as airway clearance, for patients with severe forms of COVID-19. To date, the role of respiratory physiotherapy in severe COVID-19 patients is still unclear.

Aim of this study is to assess efficacy of early rehabilitation for severe ICU-admitted COVID-19 patients as compared to a group that did not recevied physiotherapy treatment in ICU. Physiotherapy efficacy is evaluated in terms of ventilator free days (VFD) during the first 30 days after neuromuscular blockade stop.

Moreover, duration of ICU stay and patient functional status at ICU discharge will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Having laboratory confirmed COVID-19 pneumonia
* Developed hypoxemic acute respiratory failure (hARF) requiring access to ICU
* Treated by physiotherapists during the ICU stay
* Stopped the neuromuscular blokade treatment

Exclusion Criteria:

* Previuos cognitive deficit (Mini menatal state examination \<20)
PSLT Compared to Prostaglandin Analogue Eye Drops

This study aims to compare the efficacy of PSLT and the topical use of prostaglandin-like hypotensive eye drops in the treatment of ocular hypertensive or glaucomatous patients in decreasing intraocular pressure and measuring changes in functional, structural and biomechanical parameters evaluated by computerized perimetry and optical coherence tomography (OCT) related to pressure change resulting from treatments

Patients with a diagnosis of ocular hypertension or bilateral glaucoma, naive or on treatment with up to two classes of hypotensive eye drops will be invited to participate in the study.

These patients will have both eyes included in the study. A randomization will be made to allocate one eye to receive treatment with PSLT (treatment group), while the contralateral eye will receive treatment with prostaglandin eye drops (control).

Patients will be followed up for 12 months and periodically tonometry, computerized perimetry, water overload test and OCT will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ocular hypertension (IOP ≥ 24 mmHg in both eyes) or diagnosis of open-angle glaucoma (POAG) in both eyes
* Proper visualization of angle structures and 360 degree open angles in both eyes
* No previous intraocular surgery with the exception of phacoemulsification with intraocular lens implantation
* No use of systemic medications known to increase IOP

Exclusion Criteria:

* Patients using more than two glaucoma medications
* Evidence of any other eye disease that could affect IOP measurement
* Diagnosis of other types of glaucoma
* Patient with mean deviation (MD) less than -12 decibels (dB) on visual perimetry (severe disease)
* Patients with unilateral glaucoma
Assessment of Factors Which Predict Improvement in Children With PDD After a Year of Integrative Therapy

The aim of the current research is to assess the efficiency of the Integrative Therapy among children with PDD after a year of treatment in kindergartens in Ashdod, Israel.

An additional aim is to pinpoint specific changes in communication quality and functioning in different areas and recognize the prognostic factors, such as social interaction, affect and level of play. This analysis will contribute to developing more efficient treatment program, adapted to the needs of the treated children.

Integrative Therapy among children with PDD after a year of treatment in kindergartens in Ashdod, Israel.

An additional aim is to pinpoint specific changes in communication quality and functioning in different areas and recognize the prognostic factors, such as social interaction, affect and level of play. This analysis will contribute to developing more efficient treatment program, adapted to the needs of the treated children.

Eligibility Criteria:
Inclusion Criteria:

* Children with PDD
* Children aged from 2 years to 6 years

Exclusion Criteria:

* Children with severe retardation
Intermittent Fasting in Nonalcoholic Fatty Liver Disease

Although preliminary evidence suggests that intermittent fasting mimic-diet (IFD) exerts stronger effects on body weight and metabolic parameters, which may link obesity, non-alcoholic fatty liver disease (NAFLD) and major chronic diseases, compared with continuous calorie restriction (CCR), there is a lack of well-powered intervention studies. This randomized controlled trial will test whether IFD, operationalized as the "5:2 diet," has stronger effects on anthropometric and body composition characteristics, and circulating metabolic biomarkers than CCR and a control regimen in adults with NAFLD.


Eligibility Criteria:
Inclusion Criteria:

* The diagnosed criteria of fatty liver by ultrasound were presence of two of the three following criteria: increased hepatic echogenicity compared with cortical of the right kidney, blurring of liver vasculature, and deep attenuation of the ultrasonographic signal.

Exclusion Criteria:

* Excessive alcohol consumption (ethanol \> 140 g/wk for men and \> 70 g/wk for women), cirrhosis, viral hepatitis, cardiovascular disease, cancer, any consumption of nonsteroidal anti-inflammatory drugs, corticosteroids or prescriptive medicine that affect liver function, lipid and glucose metabolism.
Genetics of Polycystic Ovary Syndrome

The purpose of this study is to look at genes (DNA) and how they affect health and disease. Genes are the instruction manual for the body. The genes you get from your parents decide what you look like and how your body behaves. They can also tell us a person's risk for certain diseases and how they will respond to treatment. We will collect a saliva sample for genetic research.

Polycystic ovary syndrome (PCOS) is a common endocrine disorder of women, characterized by elevated levels of male hormones, absent menstruation, infrequent or very light menstruation, and reduced ability to reproduce. Genetic factors likely contribute to the etiology of PCOS, but no genes have been identified with certainty. The findings from these studies will enhance our understanding of the genetics of PCOS, a major contributor to female infertility. Better knowledge of "PCOS genes" will also help in predicting responses to treatments for infertility, insulin resistance, and other aspects of the disease.

Women with PCOS may be eligible to participate in this study if they are between the ages of 18 and 50 and have two living biological parents who are also willing to participate. Study participation involves telephone screening and consent and home collection by subjects (probands) and their parents of sputum (saliva) in a provided container. Specimen containers and signed consent forms will be returned to the study site by mail.

The major goal of this research project, the identification of genes contributing to PCOS, will provide basic understanding of the genotype-phenotype relationships that contribute to features of PCOS. Knowledge of "PCOS genes" would assist physicians in predicting and assessing responses to interventions that promote fertility, improve insulin sensitivity, and treat other aspects of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PCOS
* Both biological parents alive
* Yes to both answers and parents willing to participate

Exclusion Criteria:

* Healthy women
Acupuncture for the Management of Postoperative Pain in Patients With Pancreatic or Colorectal Cancer Undergoing Surgery

This trial investigates how well acupuncture works for the management of pain after surgery in patients having open colorectal or pancreatic surgery. Acupuncture may help to reduce postoperative symptoms including pain. This study may help researchers learn if acupuncture reduces after-surgery side effects and improves recovery.

PRIMARY OBJECTIVE:

I. Determine the feasibility of providing postoperative acupuncture for patients undergoing open colorectal or pancreatic surgery.

SECONDARY OBJECTIVE:

I. Compare postoperative opioid use for pain management, pain levels, and satisfaction of pain control between acupuncture and standard care groups.

EXPLORATORY OBJECTIVE:

I. Compare dietary recovery and postoperative length of stay between acupuncture and standard care groups.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (ACUPUNCTURE): Beginning the day after surgery, patients undergo acupuncture sessions over 25 minutes once daily (QD) for up to 7 days. Patients also undergo usual care including preoperative visits to the primary surgical team, anesthesia preoperative evaluation, referrals to other specialties for perioperative evaluation and optimization of comorbid conditions if necessary, surgical operations, postoperative hospitalization, and post-discharge clinic visits.

ARM II (USUAL CARE): Patients undergo usual care including preoperative visits to the primary surgical team, anesthesia preoperative evaluation, referrals to other specialties for perioperative evaluation and optimization of comorbid conditions if necessary, surgical operations, postoperative hospitalization, and post-discharge clinic visits.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing open gastrointestinal cancer resection (pancreatic or colorectal)
* Must understand and read English
* Sign a written informed consent and willing to follow protocol requirements
* Able to consent to treatment

Exclusion Criteria:

* Chronic opioid use \> 90 mg MME (morphine milligram equivalents) for more than 7 days
* Mechanical bowel obstruction
* Active seizure activity after admission
* Compromised cognitive function per referring physician and/or inability to cooperate with acupuncture procedure
* Direct admission to intensive care unit after operation will result in removal from protocol
* Prior intra-abdominal operation in the past 6 months
* Any contraindications to acupuncture including infections or inability to access acupoint sites
Linking Temporal Patterns of Modifiable Behaviors to Weight Loss Outcomes

This study is designed as an observational trial. The objective of this study is to follow-up with participants 3 years after completion of an 18-month comprehensive behavioral weight loss intervention. Outcomes of interest include change in body weight, body composition, physical activity, energy intake, and sleep. In addition, investigators will explore the associations between current physical activity, sleep, and energy intake patterns and body weight regulation.

A total of 170 participants were initially enrolled in the comprehensive behavioral weight loss intervention.In this study, investigators will conduct a follow-up visit 3 years after the completion of the intervention. Only participants who completed the behavioral weight loss intervention will be enrolled in this study. Participants will undergo testing of body weight, body composition, physical activity patterns, energy intake patterns, sleep patterns, resting metabolic rate, and total daily energy expenditure.

Eligibility Criteria:
Inclusion Criteria:

* Previous enrollment in standard behavioral weight loss intervention (NCT01985568 or NCT03411356)
* Age 20-60 (This age range has been selected based upon the participants enrolled in the Parent Trial)
* Capable and willing to give informed consent
* Possess a smartphone to install and utilize the meal timing application
* Capable and willing to wear the Actigraph, ActivPAL and Actiwatch-2 for 24 hours/day for 28 consecutive days
* Willing to complete the Total Daily Energy Expenditure (TDEE) assessment which includes multiple urine collections and drinking stable water isotopes

Exclusion Criteria:

* Being considered unsafe to participate as determined by the study physician (Dr. Catennaci)
* New diagnosis of a medical condition (not observed in the Parent Trial) which may affect weight or energy metabolism (e.g. depression, CVD, diabetes, uncontrolled hypertension, untreated thyroid, renal, hepatic diseases)
* Women who became pregnant after completing the Parent Trial
* Current use or use within the last 6 months of prescription or over-the-counter medications known to affect appetite, weight, and sleep
Radial Artery Function Following Trans-radial Cardiac Catheterisation

The investigators will study Radial artery injury and endothelial function following trans-radial cardiac catheterisation. Radial artery injury will be quantified pre- and post- angiography using Optical Coherence Tomography. The participants will also have radial endothelial function assessed using flow-mediated dilatation at baseline, 24 hours, one week, one month and three months post- angiography. Blood will be taken pre and 24 hours post angiography for characterisation of endothelial progenitor cell numbers and function. The hypothesis is that trans-radial catheterisation will cause a reduction in flow-mediated dilatation which peaks at 24 hours and recovers at three months. The investigators hope to correlate the rate of this recovery with peri-procedural progenitor cell numbers.


Eligibility Criteria:
Inclusion Criteria:

* Stable outpatient population aged between 18-85 attending for trans-radial cardiac catheterisation

Exclusion Criteria:

* Recent myocardial infarction (\<3 months)
* Severe aortic stenosis
* Chronic renal failure (eGFR\<30)
* Inability to give informed consent
A Research Study to Investigate How Well NNC0165-1875 in Combination With Semaglutide Works in People With Obesity

The study is looking at a new medicine to help people lose weight. In this study participants will either get semaglutide and NNC0165-1875 or semaglutide and a "dummy" medicine (placebo). Which treatment participants get is decided by chance. Participants will get 2 injections per week, on the same day. Participants will have to take the study medicine by use of a pre-filled pen. A pen is a medical tool with a needle used for injections under the skin. The study doctor or staff will show participants how. The study will last for about 26 weeks. Participants will have 17 visits at the clinic with the study doctor. At 4 of the clinic visits participants cannot eat and drink (water is allowed until 2 hours prior to the visit) for 8 hours before the visit.Women: Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period. Women who are able to become pregnant can participate if they agree to use contraception during the study.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
* Male or female, age above or equal to 18 years at the time of signing informed consent.
* BMI 30.0-45.0 kg/m\^2 (both inclusive) at the screening visit.

Exclusion Criteria:

* HbA1c greater than or equal to 48 mmol/mol (6.5%) as measured by a central laboratory at screening.

  * History of type 1 or type 2 diabetes mellitus.
  * Treatment with glucose-lowering agent(s) within 90 days before screening.