cyrilzakka/clinical-trials huggingface dataset:
Study of the Effects of TRV130, at Therapeutic and Supra Therapeutic Doses, on QTc Intervals

Assess the electrocardiogram effects of TRV130 relative to placebo at therapeutic and supratherapeutic doses.

* Part A of the study will assess clinical safety data of TRV130
* Part B of the study will assess the effect of single dose TRV130 on QTc

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 45 inclusive.
* Women must be either a) post-menopausal; b) surgically sterile; c) of child-bearing potential and practicing contraception or remaining sexually inactive.
* Men must be willing to abstain from sperm donation from the time of Screening through the Follow-up Visit and, if sexually active with a woman of child-bearing potential, must be protected by acceptable forms of effective contraception through the Follow-up Visit.

Exclusion Criteria:

* Past or present diseases including, but not limited to, significant medical abnormalities including: psychiatric, neurologic, pulmonary, cardiac, gastrointestinal, genitourinary, renal, metabolic, endocrinologic or autoimmune disorders.
* Has previously participated in another TRV130 clinical study.
Hand in Hand. Psychological Support and Counseling to Breast Cancer Patients and Their Partners

This study evaluates the effect of a psychological intervention to breast cancer patients and their partners compared to a control group receiving usual care

The intervention intends to improving the patient and partners well-being, quality of life and their relationship adjustment.

The couples in the intervention group participates i six to eight couple sessions. The sessions is conducted by an experienced psychologist and takes place one to five months after the patients cancer diagnosis. The control group receives usual care.

The framework of the intervention is attachment theory and the psychologists support and advise the couples in talking candidly about their feelings regarding their new life situation with cancer. The psychologist focus on the couples ability to feel comfortable and safe in each others presence.

Eligibility Criteria:
Inclusion Criteria:

* Women newly diagnosed with a primary breast cancer (in the last 4 weeks)
* Women cohabiting with a male partner in a romantic relationship
* Patient and partner speaks and reads danish

Exclusion Criteria:

* Patients having a previous cancer diagnosis
* Neoadjuvant therapy for breast cancer
* Previous hospital admission with diagnosed psychotic episodes
Diagnostic Value of 18F-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in Prosthetic Valve Endocarditis

The diagnosis of prosthetic valve endocarditis (PVE) remains challenging. In PVE cases, initial echocardiography is normal or inconclusive in almost 30% of cases, leading to a decreased diagnostic accuracy for the modified Duke criteria.

Aims: The investigators sought to determine the value of 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG PET/CT) for diagnosing PVE.

Methods: In two referral French centers (Timone Hospial, Marseille and Georges Pompidou European Hospital, Paris), the investigators plan to include consecutive patients suspected of having PVE. All of the patients will be subjected to clinical, microbiological, and echocardiographic evaluation. Cardiac PET/CT will be performed at admission and the data analysis will be based on visual interpretation and quantitative measurement of FDG uptake (SUVmax). The final diagnosis will be defined according to the clinical and/or pathological modified Duke criteria determined during a 3-month follow-up (gold standard).


Eligibility Criteria:
Inclusion Criteria:

* unexplained persistent or recurrent fever \>38°C;
* and/or unexplained increased serum C-reactive protein (CRP) level \>10 mg/L; and/or positive blood cultures, independent of the echocardiographic analysis results;
* and/or positive serological testing for Coxiella burnetii, Bartonella spp., Mycoplasma pneumoniae, Legionella pneumophila, Aspergillus spp., or Tropheryma whipplei;
* and/or a mass or a new partial prosthetic valve dehiscence observed using echocardiography.

Exclusion Criteria:

* pregnancy,
* an inability to lie flat,
* a need for urgent cardiac surgery,
* hemodynamic instability,
* cardiac surgery \<1 month ago,
* and a blood glucose level \>1.8 g/L. Patients with a poor PET/CT image quality
The Electronic Medical Records and GEnomics (eMERGE) Network Genomic Risk Assessment

The eMERGE Network embraces the opportunity to use new methods in genomic medicine, information science, and research participant engagement to identify people at very high risk for specific diseases and recommend individualized approaches to prevention and care. The investigators will conduct a prospective study, with diverse and underserved participants, across ten eMERGE study sites to evaluate clinical implementation of a Genome Informed Risk Assessment (GIRA) tool that combines genetic, family history, and clinical risk information from participants.

The purpose of the study is to determine if providing a Genome Informed Risk Assessment (GIRA) will impact clinical actions taken by providers and patients to manage disease risk and the propensity of participants to develop a disease reported in the GIRA. New tools in Genomic Medicine - polygenic risk scores, monogenic genetic screening tests, platforms to capture family history, and advanced electronic phenotyping - offer the prospect of early identification of people at especially high risk of common diseases. The investigators developed methods to generate integrated genomic risk assessments for ten conditions; a plan to engage, recruit, and retain \~25,000 subjects to receive these assessments; and methods to study outcomes in those designated high risk and those designated non-high risk. By enhancing understanding of new methods to create and deliver integrated genomic risk assessments, this project will enable prevention and early treatment of people at high risk for common diseases.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18-75
* Children 3 to \< 18
* Able to read or understand English or Spanish
* Able to provide a healthcare provider or clinician to receive results
* Willing to accept GIRA report

Exclusion Criteria:

* Inability to provide consent
* Transplant (solid organ or bone marrow) or transfusion within 8 weeks
* Research staff and investigators in eMERGE
* Not a patient at parent institution
The China Neonatal Genomes Project

The project will carry out the genetic testing of 100000 neonates in the next 5 years. The aim of the project is to construct the Chinese neonatal genome database, establish the genetic testing standard of neonatal genetic diseases, and promote the industrialization of neonatal genetic disease gene testing, improve the training system for genetic counseling.

There are about 900,000 new cases of birth defects in China every year. There are a large number of hereditary diseases, such as primary immune deficiency diseases, genetic metabolic diseases and multiple malformation syndrome, etc. It is important to identify and diagnose these diseases early in life, which can optimize the treatment strategy, improve the quality of life, and achieve the purpose of accurate treatment. To improve the level of diagnosis and prevention of genetic diseases in children is conducive to the birth and education of newborn in our country. The China Neonatal Genome Project is an important part of the China Human single Target Genome Project. The investigators plan to complete genetic testing of 100,000 newborns within 5 years, establish genetic testing standards for genetic diseases of newborns, and promote precise intervention for birth defects. The Genetic Counseling Branch of China Genetics Society, the Pediatrics Hospital affiliated to Fudan University and hundreds of hospitals in China jointly launched the Chinese newborn Genome Project in Shanghai, China. The project will carry out the genetic testing of 100000 neonates in the next 5 years. The study physician and genetic counselor will provide the consultation to families utilizing all available medical information. In the sequencing analysis of the study, this will include the medical history, physical exam, family history, standard newborn screening report. The aim of the project is to construct the Chinese neonatal genome database, establish the genetic testing standard of neonatal genetic diseases, and promote the industrialization of neonatal genetic disease gene testing, improve the training system for genetic counseling.

Eligibility Criteria:
Inclusion Criteria:

* 1. Both parents are of Chinese origin;
* 2. Postnatal age less than 28 days;
* 3. Can be retained to at least 1ml venous blood sample;
* 4. Biological parent or guardian's informed consent.

Exclusion Criteria:

* 1. the nationality of one of the parents is not the Han nationality or other national minorities;
* 2. reluctance of parents to use genetic sequencing data for subsequent research;
* 3. parents under 18 years of age or incapacitated for decision-making;
* 4. subjects older than 28 days.
* 5. multiple pregnancies;
* 6. lack of access to biological samples from which DNA can be extracted;
* 7. failure to sign informed consent
The Efficacy and Safety Study of ALbumin Therapy in Acute Ischemic Stroke

In this clinical study, the efficacy and safety of ALbumin is to be evaluated for the patients occurred within 12 hours of acute ischemic stroke.

According to the statistics of the cause of death in 2008 by the Statistics Korea, the stroke was accounted for a large proportion of cause of death among adults, as well as higher mortality, severe sequelae. These stroke in acute phase showed neurological deterioration over 50% of the patients after beginning of treatment and the sequelae resulting in that the nervous tissue was not regenerated is regarded as irreversible changes.

The test group administered 20% albumin based on 1.25g/kg (up to 100g (500ml) over 80kg body weight) to the patients occurred within 12 hours of the onset of symptoms and equal amount of placebo (saline solution (0.9% normal saline)) administered to the control group will be compared to evaluate the efficacy and safety of ALbumin for the patients with acute ischemic stroke.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age less than 75 years old
* Patients who can be administered ALbumin within 12hours of onset of acute ischemic stroke
* 5 ≤ NIHSS score \< 15
* Patients who are agreed by guardian or legal representative in case that patients have no ability to join study voluntarily

Exclusion Criteria:

* Medical history of congestive heart failure or patients who are judged congestive heart failure on admission.
* Patients with cardiac edema or pulmonary edema.
* Medical history of myocardial infarction within the past six months.
* Patients who have serious aortic stenosis and mitral valve stenosis.
* Signs or symptoms of acute MI on admission (Serum troponin level ≤0.1 ug/L)
* Those Who had cardiac surgery.
* Onset of cerebral infarction within the past three months.
* Before onset of cerebral infarction, patients who were diagnosed as Historical mRS ≥ 2.
* Patients who received treatment of thrombolysis or who planned for treatment of thrombolysis.
* Acute tachyarrhythmia or bradyarrhythmia with hemodynamic instability on admission.
* Acute or chronic lung disease requiring supplemental O2 therapy on admission
* Severe anemia (Hb \< 8.0)
* Severe dehydration (defined as decreased skin turgor, dry oral mucous membrane, tachycardia(\>100/min), and oliguria)
* Fever, defined as core body temperature\>37.5 ℃
* Serum creatinine \> 2.0 mg/dL
* History of allergy to albumin.
* Patients who have side effects of albumin (hyperergia to shock, fever, facial flushing,urticarial, algor, lumbodynia)
* Pregnancy
* Patients who are in life-threatening or stupor coma situation.
* Evidence of intracranial hemorrhage (intracerebral hematoma (ICH), subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH)) on admission CT or MRI scan.
* Patients who are not the normal, excesses of circulating blood.
* Haemolytic anemia, anemia due to blood loss.
* Immunodeficiency disease, immunosuppression.
* Blood pressure higher than 180/110 mmHg on admission.
Observational Study of the EnligHTN Renal Denervation System in Europe

The purpose of this observational study is to further evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of participants with uncontrolled hypertension in clinical routine practice.

The EnligHTN European Observational study is designed to collect more data, critical to the benefit of the therapy, within a clinical routine setting.

Eligibility Criteria:
Inclusion Criteria:

* Subject is planned to undergo a renal denervation procedure for the treatment of hypertension
* Subject is ≥18 years of age at time of consent
* Subject must be able and willing to provide written informed consent
* Subject must be able and willing to comply with the required follow-up schedule
* Subject has office SBP ≥ 140 mmHg
* Subject has established hypertension (diagnosed ≥12 months prior to baseline) and is on a guideline based drug regimen at a stable (≥ 14 days) and a fully tolerated dose consisting of ≥3 anti-hypertensive medications (including 1 diuretic)

Exclusion Criteria:

* Subject has known significant renovascular abnormalities such as renal artery stenosis \> 30%
* Subject has undergone prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent grafts
* Subject has a history of hemodynamically significant valvular heart disease
* Subject has blood clotting abnormalities
* Subject life expectancy is \< 12 months, as determined by the Study Investigator
* Subject is participating in another clinical study which has the potential to impact his/her hypertension management (pharmaceutical/ device/ homeopathic)
* Subject is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods
* Subject has active systemic infection
* Subject has known renal arteries with diameter(s) \< 4 mm
* Subject has an estimated GFR \<45 mL/min per 1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula
* Subject had a renal transplant or is awaiting a renal transplant
Process Versus Outcomes Incentives for Lipid Management

In a 4-arm, randomized controlled trial, we will evaluate the relative effectiveness and cost-effectiveness of improving cholesterol levels among participants who are at high risk of CVD and who have elevated LDL cholesterol levels by testing process versus outcomes financial incentives. Participants will use electronic pill bottles that continuously monitor statin adherence. The primary outcome will be change in LDL cholesterol over 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Individuals at high risk of a cardiac event, specifically one of the following:
* Individuals with clinical ASCVD (defined as diagnosis with myocardial infarction, stroke, or peripheral vascular disease) with an LDL greater than or equal to 100 mg/dl ;
* Individuals with Diabetes (between the ages of 40-75) with an LDL greater than or equal to 100 mg/dl;
* Individuals without clinical ASCVD or diabetes with LDLC with an LDL greater than or equal to 100 mg/dl and estimated 10-year ASCVD risk 7.5%;
* Individuals without clinical ASCVD or diabetes with LDL cholesterol 190 mg/dl
* A prescription filled for a statin medication within the last 12 months (derived from pharmacy records);
* Low medication adherence on self-report completed during enrollment

Exclusion Criteria:

* Under 18 years old
* A contraindication to further statin use or have suffered statin side effects, such as myopathy
* Will not or cannot give consent
* A history of active or progressive liver disease
* Participating in another clinical trial with related aims
* Co-morbidities likely to lead to death within a short period (e.g. metastatic cancer)
HPV Integration and Tumorigenesis of Uterine Cervical Adenocarcinoma

This study aims to analyze the multi-omics results between uterine cervical adenocarcinoma patients with and without human papillomavirus (HPV) infections. The multi-omics profiles include genome wide association study (GWAS), whole exome sequencing, analysis of transcriptomics and metabolomics. The HPV integration status is interpreted by GWAS. A comprehensive multi-omics will reveal the role of HPV integration in the molecular mechanism of tumorigenesis and prognosis of uterine cervical adenocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed primary adenocarcinoma of the uterine cervix
* Signed an approved informed consents
* Feasible for biopsy

Exclusion Criteria:

* Not meeting all of the inclusion criteria
Exercise and Vascular Function in Postmenopausal Females with Hypertension

The treatment of high blood pressure, or hypertension, is multifaceted and can include pharmacological therapies (i.e., medications) and lifestyle modifications such as physical activity. Chronotherapy, which describes timing of a treatment with the body's daily rhythms, has recently been used with hypertension medications and has been shown to be effective at lowering blood pressure and reducing the risk of cardiovascular disease events. Specifically, taking medications in the evening was shown to be more effective than morning medication routines. Little information is available about the effectiveness of chronotherapy combined with exercise (i.e., planned physical activity) interventions in older adults with hypertension. The purpose of this study is to examine how exercise performed in the morning and early evening affects blood pressure and other measures of blood vessel health in postmenopausal females with hypertension.

Blood pressure has an internal rhythm associated with the 24-hr clock. Nocturnal blood pressure (BP) is a key contributor to cardiovascular health and may be improved by exercise. Moreover, the time of day of the exercise may be a key factor. This study aims to evaluate the effect of evening exercise on BP and other measures of vascular function in older females with hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Systolic BP equal to or greater than 130 mmHg without BP medication or greater than 120 mmHg with medication and diastolic blood pressure equal to and greater than 80 mmHg
* 55-80 years old
* Post-menopausal female
* Able to walk without assistance

Exclusion Criteria:

* Habitually physically active defined as 150 minutes of moderate-intensity or 75 minutes of vigorous-intensity aerobic physical activity per week
* Overt pulmonary disease/condition as follows: chronic bronchitis, chronic obstructive pulmonary disease, emphysema, or pulmonary hypertension
* Cardiometabolic disease/condition as follows: diabetes, heart failure, peripheral arterial disease, stroke, coronary artery disease, renal disease, secondary hypertension, chronic venous insufficiency or deep vein thrombosis within last 6 months
* Cancer within last 5 years
* Body mass index \>39 kg/m2
* Current smoking or vape
* Evening shift work
A Study of CAT-1004 Biomarkers in Healthy Subjects

This study is being conducted to assess mechanistic blood biomarkers of CAT-1004 in healthy humans.


Eligibility Criteria:
Inclusion Criteria:

* Good health as determined by medical history, vital signs, EGC, physical exam and clinical lab results
* BMI between 18 and 30 kg/m2 inclusive

Exclusion Criteria:

* Viral or bacterial infection within 21 days prior to randomization
* Use of prescription drugs, nonprescription drugs, herbals and dietary supplements within 7 days prior to randomization
The Effect of Home-based Velocity Training in Individuals With Total Knee Replacement

The purpose of this study will be to find out the effect of two different interventions on muscle strength, ability to produce muscle force quickly (power), daily function, and number of steps and physical activity an individual with total knee replacement do daily.

The research hypotheses for this study will be as follows:

* For individuals who are at least 6 months post-total knee replacement, home-based high-velocity training exercises will result in significantly greater improvements in muscle strength and power compared to those who receive a walking program only.
* For individuals who are at least 6 months post-total knee replacement, home based high-velocity training exercises will result in significantly greater improvements of daily function(eg. sit to stand, climb a set of stairs)than those who receive a walking program only.
* For individuals who are at least 6 months post-total knee replacement, home based high-velocity training exercises will result in significantly greater improvements in physical activity behavior (eg. number of steps per day)compared to those who receive a walking program only.


Eligibility Criteria:
Inclusion Criteria:

* Men and women who are at least 40 years of age will qualify if they had a primary unilateral total knee replacement (TKR) 6 to 18 months.

Exclusion Criteria:

* other lower extremity prosthetic implants other than the current TKR
* revision TKR or plan for revision
* diagnosis of severe osteoarthritis in the uninvolved knee or either hip joints
* recent low extremity injury or significant pain that increases during weight bearing or other functional performance
* diagnosis of neurologic deficits
* decreased cognitive status that might affect the ability to follow instructions
* significant cardiovascular and/or pulmonary disease that limits function
ZOSTAVAX(R) Local Registration Trial (V211-019)

The purpose of this study is to obtain safety and immunogenicity data for the refrigerator-stable formulation of ZOSTAVAX(R) in taiwanese adults.


Eligibility Criteria:
Inclusion Criteria:

* Subject Is Older Than 50 Years Of Age On Day Of Signing Informed Consent
* All Females Must Be Postmenopausal Or Have A Negative Serum Or Urine Pregnancy Test

  * Postmenopausal Is Defined As 6 Months Of Spontaneous Amenorrhea With Serum Follicle Stimulating Hormone (Fsh) Levels In The Postmenopausal Range As Determined By The Laboratory, Or 12 Months Of Spontaneous Amenorrhea
* A Subject Who Is Of Reproductive Potential Must Agree To Remain Abstinent Or Use (Or Have Her Partner Use) 2 Acceptable Methods Of Birth Control For Three Months After Vaccination

  * Acceptable Methods Of Birth Control Are: Intrauterine Device, Diaphragm With Spermicide, Contraceptive Sponge, Oral Contraceptive Pills, Condom, Tubal Ligation, And Vasectomy
* Subject Must Sign Informed Consent Prior To Any Study Procedure
* Subject Must Be afebrile (\<38.3 °C Oral) On Day Of Vaccination
* Any Underlying Chronic Illness Must Be In Stable Condition