cyrilzakka/clinical-trials huggingface dataset:
Epidemiological and Genetic Studies of Body Mass Index

To identify genes involved in obesity.

BACKGROUND:

Increased levels of body mass index (BMI) are associated with increased mortality and morbidity from cardiovascular disease, hypertension, diabetes and other disorders. The frequency of obesity and its associated health-related problems is increasing in the American population.

DESIGN NARRATIVE:

The study builds upon a two-stage genome scan for BMI performed in the NHLBI Family Heart Study (FHS). In the first, 101 pedigrees were examined with 1027 persons genotyped and a LOD of 2.2 was found on chromosome 7. In stage 2, 135 sibships of 380 persons were examined , and a LOD of 3.2 was found for the same locus. Compelling linkage was found in the combined study (LOD = 4.9, chr 7q31.3, 137cM). The LOD or logarithm of odds is a statistical estimate of whether two loci (the sites of genes) are likely to lie near each other on a chromosome and are therefore likely to be inherited together as a package.

A novel strategy will be used which combines three cutting edge methods: (1) Regression Tree analyses to identify a homogenous subset of families with evidence for BMI linkage to 7q31.3; (2) DNA pooling of samples from linked versus unlinked families; and (3) quantitative PCR of DNA pools for very high-density single nucleotide polymorphism (SNP) mapping. The combination of these methods will permit a cost effective approach for the identification of genetic polymorphisms in linkage disequilibrium with BMI, and has the potential to become a widely adopted method for gene localization of complex traits.

The study was extended through January, 2008 to show compelling evidence for a haplotype in the 5' region of the Leptin gene (p\<0.00005) influencing BMI among men in the sample. The study will further demonstrate that the responsible gene in this region is not Leptin. SNP and haplotype association studies implicate three strong candidate loci and other loci also warrant additional study. The study will confirm SNP association in an independent study of 200 families showing linkage to the same position (from Dr. R. Arlen Price's group). Those loci with confirmed association will be further characterized by sequencing, genotyping new polymorphisms, and gene expression studies to identify the responsible genes.

Eligibility Criteria:
The PI was not involved in the study recruitment or examination of the subjects form which the adipose samples were obtained and all data were de-identified.
Belgian Registry on Coronary Function Testing

The goal of this prospective, multicenter registy is to describe the 'real-world' use of coronary function tests, which may consist of bolus thermodilution measurements of coronary microvascular function and/or invasive vasoreactivity tests with acetylcholine, in the current Belgian routine practice. The main questions it aims to answer are:

* how frequent are coronary function tests performed
* what is the indication for coronary function tests
* what is the frequency of coronary microvascular dysfunction
* what is the frequency of coronary artery vasospasm

From each participant, data will be collected from their medical files concerning cardiovascular risk factors, relevant past medical history, non-invasive tests, procedural data, and follow-up data from routine in-patient visits. Their are no specific study visits. Optionally, patients will be asked to fill in questionnaires about anginal symptoms and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for coronary function test, comprising of intracoronary bolus thermodilution measurements of microvascular function, and/or intracoronary vasoreactivity tests with acetylcholine.
* Subject understands the study requirements and provides written informed consent.

Exclusion Criteria:

* Subject is participating in another investigational clinical trial that may cause non-compliance with the protocol or confound data interpretation.
* Subject intends to participate in another investigational clinical trial that may cause non-compliance with the protocol or confound data interpretation.
* Documented or suspected pregnancy.
* Inability to provide written informed consent.
Low Serum Ficolin-3 Levels on Admission Are Associated With Poor Outcomes After Severe Traumatic Brain Injury

The current study was designed to investigate the change of serum ficolin-3 levels and assess the prognostic predictive effect of serum ficolin-3 levels in the patients with severe traumatic brain injury.

Complement activation is one of the pathological mechanisms that contribute to the secondary brain injury after traumatic brain injury. Ficolin-mediated lectin pathways of complement activation contribute to the pathogenesis of ischemic stroke and may be additive to complement-independent inflammatory processes. Lower serum ficolin-3 levels have been demonstrated to be highly associated with unfavorable outcome after ischemic stroke. This prospective observatory study was designed to investigate the relationship between serum ficolin-3 levels and 1-week mortality, 6-month mortality and 6-month unfavorable outcome (defined as Glasgow Outcome Scale score of 1-3) in patients with severe traumatic brain injury. This study recruited 128 patients and 128 sex- and age- matched healthy controls. Serum ficolin-3 levels on admission were measured by sandwich immunoassays. It was postulated that serum ficolin-3 levels were correlated with Glasgow Coma Scale scores and ficolin-3 was identified as an independent prognostic predictor for 1-week mortality, 6-month mortality and 6-month unfavorable outcome. Thus, it was proposed that lower serum ficolin-3 levels, correlated with injury severity reflected by Glasgow Outcome Scale scores, had the potential to be the useful, complementary tool to predict short- or long- term clinical outcome after severe traumatic brain injury.

Eligibility Criteria:
Inclusion Criteria:

* Isolated head trauma
* Postresuscitation Glasgow Coma Scale score of 8 or less.

Exclusion Criteria:

* Less than 18 years of age
* Admission time \> 6 hours
* Previous head trauma
* Neurological disease including ischemic or hemorrhagic stroke
* Use of antiplatelet or anticoagulant medication
* Diabetes mellitus
* Hypertension
* Presence of other prior systemic diseases including uremia, liver cirrhosis, malignancy, and chronic heart or lung disease
Study Effect of VIA-2291 on Vascular Inflammation

This is a dose ranging study to compare the effect of VIA-2291 vs. Placebo on various inflammatory biomarkers in patients with recent acute coronary events

This is a Phase II, randomized, double-blind, placebo-controlled study of the effect of VIA-2291 on atherosclerotic vascular inflammation

Eligibility Criteria:
Inclusion Criteria:

* Female patients are to be of non-childbearing potential
* Patient has suffered an ST elevation myocardial infarction (MI), non-ST elevation MI, or unstable angina 21 days (±3 days) prior to study randomization
* Patient has documented coronary artery disease

Exclusion Criteria:

* Renal insufficiency defined as creatinine \>1.5 x upper limit of normal (ULN)
* Cirrhosis, recent hepatitis, ALT \>1.5 x ULN or ALT \> 1 x ULN and at least one other liver function test
* Uncontrolled diabetes mellitus within 1 month prior to study screening
* Congestive heart failure (CHF) defined by the New York Heart Association as functional Class III or IV
* Previous coronary artery bypass graft (CABG) surgery
* Planned additional cardiac intervention
* Recurrence of ST elevation MI, non-ST elevation MI, or unstable angina less than 18 days prior to randomization
* Current atrial fibrillation, atrial flutter, or frequent premature ventricular contractions
* Acetaminophen use in any form in the 7 days before enrollment
Antibiotic Loaded Cement After TKA

This study will provide us with clear information about the postoperative concentration of antibiotic reached in synovial fluid, thereby helping surgeons to determine if concentration could potentially prevent the growth and regrowth of common infecting microorganisms (based on their MIC and MBEC). There is a need to define the actual benefit of antibiotic-loaded bone cement, because the addition of antibiotic can reduce its mechanical strength. Moreover, if sub-therapeutic antibiotic levels are achieved, this could facilitate the emergence of resistant bacterial strains. Amidst the transition towards value-based care, our research will enable surgeons to decide whether antibiotic-loaded cement is truly cost-effective in the prevention of PJI.


Eligibility Criteria:
Inclusion Criteria:

* All participants undergoing cemented primary total knee arthroplasty (TKA) who are 18 years or older.

Exclusion Criteria:

* Withdrawal of informed consent,
* allergy to any of the study medications or to bone cement,
* use of antibiotics within 4 weeks before collecting the samples (not including perioperative antimicrobial prophylaxis),
* high risk of infection,
* history of peri-articular injections for multimodal pain management.
Transition of Single Surgeon Bariatric Service to an Interdisciplinary Multiple Surgeon Model

This retrospective study will analyse the transition of an Australian hospital which significantly increased volume of bariatric operations after introduction of a clinical pathway, and to assess the outcomes. Barriers to introduction of the multidisciplinary pathway and the means to overcome these will also be analysed and discussed. The analysis will also determine if there are any other areas of bariatric surgery which can be further investigated to optimise current practice.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have had bariatric surgery at The Queen Elizabeth Hospital between 2008-2018

Exclusion Criteria:

* nil
A Digital Therapeutic Solution for Cancer Patients

This is a randomized, controlled trial to assess the feasibility of Sidekick Health's digital programs for cancer patients. Participants will be treated with standard of care (SoC) in combination with the digital programs, or SoC only.

We will compare the effect of the digital programs in addition to SoC to SoC only, on the cancer-related quality of life (QoL), cancer-related fatigue, and side-effect management.

In line with the growing need to support cancer patients with lifestyle modifications, education and disease management, Sidekick Health developed 14-week digital programs addressing the specific needs of patients with cancers. In this study, the effect of adding the Sidekick's digital program to the standard of care (SoC) treatment for cancer patients will be assessed, with focus on prostate cancer, colorectal cancer and lung cancer. The digital programs investigated are a general oncology program (SK-411), or specific programs tailored for patients diagnosed with prostate cancer (PC-SK-451), colorectal cancer (CRC-SK-441), or lung cancer (LC-SK-431).

The study will be a single center feasibility study with an intervention group and a comparison group recruiting 84 cancer patients in active cancer treatment from Landspítali University Hospital. Patients will be randomized to receive either the SoC treatment alone or SoC with the addition of the digital program. Active cancer treatment is defined as chemotherapy, hormonal therapy, targeted therapy, immunotherapy, or radiation therapy according to standard treatment guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Adults (at least 18 years of age) diagnosed with cancer
* Has started active cancer treatment (chemotherapy, hormonal therapy, targeted therapy, immunotherapy, radiotherapy) during the study
* Cancer diagnosis (all stages), with a focus on prostate cancer, lung cancer, or colorectal cancer
* Understands verbal and written Icelandic or English
* Owning a smartphone compatible with the Sidekick Health app and capable of using it.
* Capacity to give informed consent
* Willing to comply with all scheduled visits, study interventions, and procedures

Exclusion Criteria:

* Pregnancy
* Surgeries in the last 4 weeks prior to participation in the study
* Surgeries planned during the 14-weeks intervention
* Not able to comply with study intervention or scheduled measures and visits, as assessed by oncologist
* Current breast cancer diagnosis
Immune Suppression Of Infants Treated With Steroids

The goal of this study is to clarify the degree of immune suppression in infants requiring therapy and to create guidelines for evaluation and prevention of infection in infants on oral steroids for hemangiomas.

Infants with large or complicated hemangiomas are often treated systemically with oral steroids. The side effects of the drug on young infants has not been studied. The goal of this study is to clarify the degree of immune suppression in infants requiring therapy and to create guidelines for evaluation and prevention of infection in infants on oral steroids for hemangiomas. Prednisone will be started according to established standard of care. Visits will occur every four weeks for follow-up. There will be six blood draws from baseline to completion of study. Approximately up to 1 ½ teaspoons per blood sample will be drawn to test the strength of the infant's immune system. Participation in this study will last up to 14 months or until stabilization of the hemangioma. Evaluation will occur 12 weeks after discontinuing the steroid for its long-term effects on the immune system.

Eligibility Criteria:
Inclusion Criteria:

* Infants \< 6 months of age with infantile hemangiomas requiring treatment with oral corticosteroids
* Infant must be enrolled prior to initiation of steroid therapy

Exclusion Criteria:

* Infants \> 6 months of age
* Infants already receiving oral corticosteroid treatment prior to the start of this study
* Infants with know immunodeficiencies
* Infants receiving other oral medications for the treatment of hemangiomas
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)

Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).

Primary Objective of the study:

To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy in comparison with ezetimibe after 24 weeks of treatment in participants with hypercholesterolemia at high cardiovascular (CV) risk.

Secondary Objectives:

* To evaluate the effect of alirocumab in comparison with ezetimibe on LDL-C at other time points
* To evaluate the effect of alirocumab on other lipid parameters
* To evaluate the safety and tolerability of alirocumab

The maximum study duration was 115 weeks per participant, including a 3-week screening period, 104-week randomized treatment period and 8-week follow-up period.

Eligibility Criteria:
Inclusion criteria:

Participants with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who were not adequately controlled with a maximally tolerated daily dose of statin at stable dose for at least 4 weeks prior to the screening visit (Week -2).

Exclusion criteria:

* Age \< 18 or legal age of adulthood, whichever was greater
* Participants without established CHD or CHD risk equivalents
* LDL-C \<70 mg/dL (\<1.81 mmol/L) and participants with a history of documented cardiovascular disease
* LDL-C \<100 mg/dL (\<2.59 mmol/L) and participants without a history of documented CV disease
* Fasting serum triglycerides \>400 mg/dL (\>4.52 mmol/L)

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Comparison of the Effectiveness of a Web Fracture Liaison Service (e_FLS) to Fracture Liaison Services in France: the evAB Study (evAB)

The purpose of this study is to compare web FLS model (e_FLS) to conventional FLS in terms of increasing the proportion of patients receiving an antiosteoporotic treatment in the year after a low trauma fracture.

Osteoporotic fractures such as hip fractures and severe fractures are associated with increased morbidity and mortality and impose a large financial burden on healthcare systems. Patients with osteoporosis-related fractures are at higher risk of subsequent fractures. Other severe fractures (pelvis, vertebrae, humerus) have similar consequences, pelvis. The risk of refracture after fracture depends on the time: it is 5 times higher in the first 2-3 years, and 2 times higher after. This notion of Imminent Fracture Risk is the basis for the development of post-fracture care pathways called "fracture liaison. The implementation of FLS is the most effective way to reduce the risk of secondary fracture. Despite their success, FLS programs are not an integral part of post-fracture care throughout the France. The investigators believe that the barriers to the implementation of such a pathway are multiple and are largely related to the lack of accessibility for patients to FLS, and to the mobilization of important and unsustainable human resources. Some French public hospitals or institutions are currently building some e_FLS models based on an automatic detection of patients with fractures, and a on a cloud-based system where practitioners across the health care sector can communicate and jointly manage osteoporotic patients. The investigators' hypothesis is that this web FLS (e_FLS) is at least as effective as the classical FLS for the secondary fracture prevention.

The objective of the investigators' study is to compare web FLS model (e_FLS) to conventional FLS in terms of increasing the proportion of patients receiving an antiosteoporotic treatment in the year after a low trauma fracture (evAB project).

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged above 60 years, living in France, with fragility fractures in response to low-energy trauma (e.g., a fall from standing height).
* The patient or his legal representative does not object to the patient's participation in the research Note: Patients in guardianship or curatorship can be included in this protocol

Exclusion Criteria:

* Pathological fractures, high trauma fractures and per prosthetic fractures.
* Non registration with a social security scheme (holder or beneficiary).
Safety and Efficacy of Topical Recombinant Human Thrombin(rhThrombin) for Surgical Hemostasis

A multicenter, stratified randomized, double-blind, placebo-controlled, phase 3 clinical trial.

After establishing eligibility, subjects will be randomized in a 2:1 ratio to receive rhThrombin (1000 U/mL) or placebo. During a surgical procedure, study participants will be treated with blinded study drug (rhThrombin or placebo) in combination with an absorbable gelatin sponge at appropriate bleeding evaluation site(s). 510 patients will participate in the study.

In this study, stratified random enrollment was conducted according to the condition(experimental group or control group) of the subjects.Stratification factors were centered, gender (male/female) and age (18 ≤ age \<60/60 ≤ age ≤70).

Eligibility Criteria:
Inclusion Criteria:

* 18 to 70 years old (including 18 and 70 years old), male or female;
* Patients with wedge-shaped liver resection or anatomical liver resection(1-5 consecutive liver segments);
* After the operation was controlled by standard surgical hemostasis, there were still patients with mild/moderate bleeding lesions (bleeding, non-arterial bleeding);
* Electrolytes (K, Na, CL, Ca, P, Mg) and ECG are normal or abnormal, Investigators believe that patients who do not affect surgery
* No other therapeutic surgery within 4 weeks before enrollment;
* Patients who have not used blood products within 24 hours before surgery;
* In compliance with the requirements of the ethics committee, patients voluntarily signed informed consent and were able to conduct visits as required by the protocol.

Exclusion Criteria:

* Known diseases of the blood system, including patients with coagulopathy or bleeding tendency;
* Patients with unstable vital signs for more than 24 hours;
* A history of severe heart, brain, and vascular disease within 6 months, including patients with a history of TIA, non-disabling cerebral infarction, myocardial infarction, unstable angina, or intracranial hemorrhage;
* Active bleeding or abnormal coagulation function (PT\>16s, APTT\>43s, INR≥2) or receiving thrombolysis, anticoagulation or antiplatelet therapy;
* Have used drugs that affect the function of the coagulation system within 1 week before surgery (including but not limited to: aspirin, clopidogrel, ticlopidine, fensulfamide, desmopressin, aminotoluic acid, dipyridamole, ginkgo Leaf preparations, heparin, warfarin, citrate, hemagglutinin, Vk, anti-fibrotic solvents, hemostatic, Vc, etc.);
* Women during pregnancy and lactation;
* Participants who participated in clinical trials of other drugs within 4 weeks before enrollment.
EMPOWER - BAME vs COVID

The COVID-19 virus pandemic has massively affected us all. Moreover, there is a disproportionately high number of COVID-19 severe infections and deaths in British Black, Asian and minority ethnic (BAME) patients. This clinical study plans to discover new ways of protecting people from this virus by looking at our DNA and biology.

The COVID-19 virus pandemic has massively affected us all. We now know there is a much larger proportion of British Black, Asian and minority ethnic (BAME) patients suffering from COVID-19 infections. This disproportionate level of infection and severity of disease has raised concerns and worries. Other research from April 2020 showed that 71% of the nurses and midwives and 94% of the doctors and dentists that died of COVID-19 infections were from a BAME background despite this group representing 20% and 44% of the workforce respectively. The survival picture is also grim for Black and Asian members of the public where we see disproportionately high rates of deaths. Research estimates that our DNA and the environment equally influence the risk for infection. This clinical study plans to better understand our DNA. Some of the things we will be looking at is age, sex, ethnicity and any illnesses such as diabetes or blood pressure. We will ask people for some spit and look at their medical records. This may help us find some of the reasons why this virus has different effects on people and how we might protect people from COVID-19.

Eligibility Criteria:
Inclusion Criteria:

1. All competent adult and children above the age of 5 years
2. Subjects agree to:

   1. Gift saliva (spit) samples
   2. Provide Consent for access to medical and health records

Exclusion Criteria:

1. Patient is not registered with the NHS for care.
2. Adults lacking capacity
3. Children under the age of 6 years.