linjc16/ctgov huggingface dataset:
Potassium and Sodium to Control Blood Pressure in Hypertensives

Study Overview
=================
Brief Summary
-----------------
To examine the role of dietary sodium reduction with and without potassium supplementation in controlling blood pressure in hypertensive men.

Detailed Description
-----------------
BACKGROUND: Appropriately increased interest and concern about high blood pressure as a major public health problem coincided with the indication that the risks of hypertension-related morbidity and mortality could be reduced by reduction of blood pressure. Consensus suggestions that individualized approaches be used in treating patients with mild hypertension stimulated further investigations of non-pharmacological methods. Such investigations were also of considerable interest in relation to understanding the physiology of blood pressure control as well as the development of less costly non-drug therapies. Interest was heightened by information suggesting that there might be distinctly harmful side effects related to antihypertensive drug therapy, particularly thiazide diuretics, in some settings. Studies of non-drug therapies included dietary modifications primarily involving weight reduction and sodium restriction with increasing recent concern about other factors such as alcohol intake, dietary fat, calcium, magnesium, and potassium intake. DESIGN NARRATIVE: Randomized, double-blind. One hundred forty-five subjects were randomized into a low sodium placebo group in which sodium intake was restricted to no more than 80 mEq/day, 142 subjects into a potassium supplementation (96 mEq/day) group whose sodium intake was also restricted to no more than 80 mEq/day. After 12 weeks of intervention, antihypertensive drugs were withdrawn. Follow-up of each participant was for at least two years. The primary endpoint was the proportion of subjects requiring antihypertensive medication at various points following randomization.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Hypertension, Vascular Diseases

Intervention / Treatment
-----------------
* Behavioral: diet, sodium-restricted
* Behavioral: diet, potassium-supplementation


Participation Criteria
=================
Eligibility Criteria
-----------------
Men, ages 45 to 68. Subjects were hypertensive, were treated for at least 3.5 years with antihypertensive drugs and whose diastolic blood pressure was less than 90 mm Hg.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 68 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: diet, sodium-restricted|nan|
|Behavioral: diet, potassium-supplementation|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Study of Torcetrapib/Atorvastatin vs Atorvastatin Alone or Placebo in Patients With High Cholesterol

Study Overview
=================
Brief Summary
-----------------
The Torcetrapib project was terminated on December 2, 2006 due to safety findings. A study to look at lipid levels in subjects taking the study drug, Atorvastatin alone or placebo.

Detailed Description
-----------------
For additional information please call: 1-800-718-1021

Official Title
-----------------
A Phase 3, Double Blind, Placebo-Controlled, Randomized, Parallel Group, Multicenter Study of the Efficacy, Safety and Tolerability of Fixed Combination Torcetrapib/Atorvastatin Administered Orally Once Daily for 6 Months, Compared to Atorvastatin Alone or Placebo in Subjects With Mixed Dyslipidemia (Fredrickson Types IIa and IIb).

Conditions
-----------------
Hyperlipidemia

Intervention / Treatment
-----------------
* Drug: torcetrapib/atorvastatin
* Drug: atorvastatin
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects with elevated cholesterol Exclusion Criteria: Women who are pregnant or lactating, or planning to become pregnant. Intolerance to statin therapy resulting in withdrawal Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors Subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluation of response, or render unlikely that the subject would complete the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: torcetrapib/atorvastatin|nan|
|Drug: atorvastatin|nan|
|Drug: placebo|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL and HDL levels |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| other lipid parameters |  |  |
S-100B and Neuron-specific Enolase (NSE) in Spinal Trauma

Study Overview
=================
Brief Summary
-----------------
The investigators are studying the clinical worth of the serum markers S-100B and NSE in patients with spinal cord injuries e.g. in patients with vertebral fractures. If there is a injury to the neuronal structures these two proteins could be secreted into the serum and add evidence to the severity of the injury.

Official Title
-----------------
The Clinical Use of S-100B and NSE in Spinal Cord Injuries

Conditions
-----------------
Spinal Cord Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: vertebral fracture injuries to the vertebral spine Exclusion Criteria: head trauma polytrauma

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>patients with neurological symptoms | |
| 2<br>patients without neurological symptoms | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological Symptoms |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vertebral fracture, spinal cord injury
Electrical Stimulation in Peripheral Arterial Disease

Study Overview
=================
Brief Summary
-----------------
The investigators wish to investigate the effects of neuromuscular stimulation on intermittent claudication.

Official Title
-----------------
Electrical Stimulation in Peripheral Arterial Disease

Conditions
-----------------
Peripheral Arterial Disease

Intervention / Treatment
-----------------
* Device: Bilateral NMES legs
* Other: Best medical therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of stable intermittent claudication (>6 months) with confirmation by medical imaging ABPI<0.9 Absolute walking distance <500m Exclusion Criteria: Pregnancy Cardiac pacemaker Previous lower limb major amputation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Best medical therapy<br>Claudicants treated according to local protocol - no added treatment | Other: Best medical therapy<br>* Treated according to local NHS protocol. At Imperial College Healthcare Trust, this will include diagnostic tests (medical interview and examination, ultrasound of blood vessels, diagnostic treadmill test, blood tests and Xrays as appropriate). This also includes lifestyle advice, treatment with appropriate drugs such as aspirin and statins, and supervised exercise.<br>|
| Experimental: Best medical therapy plus NMES<br>In addition to best medical therapy, subjects will receive bilateral neuromuscular stimulation of their legs, 4 hours per day. | Device: Bilateral NMES legs<br>* Stimulation with the geko(TM) device, Firstkind Ltd, UK. 4 hours per day, bilateral, applied to the skin overlying the common peroneal nerve<br>Other: Best medical therapy<br>* Treated according to local NHS protocol. At Imperial College Healthcare Trust, this will include diagnostic tests (medical interview and examination, ultrasound of blood vessels, diagnostic treadmill test, blood tests and Xrays as appropriate). This also includes lifestyle advice, treatment with appropriate drugs such as aspirin and statins, and supervised exercise.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute walking distance | Treadmill test (2mph, 0% grade increased by 3.5% every 3 minutes to a maximum of 15% | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Claudication distance | Treadmill test (as per absolute walking distance) | 6 weeks |
Genomics, Single Nucleotide Polymorphisms (SNPs), and Clinical Neonatology

Study Overview
=================
Brief Summary
-----------------
This research seeks to establish a neonatal DNA Tissue Bank to find out if differences in small segments of DNA predispose babies to Chronic Lung Disease (CLD), Periventricular Brain Injury (PVI), Necrotizing Enterocolitis (NEC), or Hypoxic Respiratory Failure (HRF).

Detailed Description
-----------------
This genetic predisposition study does not involve investigational drugs, devices, or treatments. Our broad goal is to identify genomic factors, which contribute to the development or exacerbation of common and critical illnesses that affect preterm and near-term infants. We seek to accomplish this goal in the following ways: First: to test candidate gene DNA variations and link already identified single nucleotide polymorphisms (SNPs) producing functional alterations to the risk of clinically important disorders. Second: to utilize a whole-genomic approach to identify SNPs not previously linked to the risk of development or progression of neonatal disorders.

Official Title
-----------------
Genomics, SNPs, and Clinical Neonatology

Conditions
-----------------
Lung Disease, Brain Injury, Necrotizing Enterocolitis, Respiratory Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Less than 34 weeks gestation and less than 1500 g at birth Greater than or equal to 36 weeks gestation and either with hypoxic respiratory failure or with mild respiratory distress never requiring assisted ventilation Exclusion Criteria: Life threatening anomalies of any organ system (e.g., cardiac, thoracic, lethal, or non-lethal chromosomal abnormalities)
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DNA, Genomics, SNPs, Neonatology, Chronic Lung Disease, Periventricular Brain Injury, Hypoxic Respiratory Failure
The Clinical Evaluation of Efficacy of Lipid-Lowing Tea on Hyperlipidemia Patients' Lipid Profiles

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the Lipid-lowing Tea is effective and safe in the treatment of Hyperlipidemia Patients

Conditions
-----------------
Hyperlipidemia

Intervention / Treatment
-----------------
* Drug: Lipid-lowing Tea


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient aged 20-65 years;either sex Patient diagnosed with hyperlipidemia(fasting levels of TC>=200mg/dL),or TG>=200mg/dL but <400mg/dL,or LDL-C>=130mg/dL) Patient who has signed the informed consent form Exclusion Criteria: Patient with pregnancy (or child bearing potential),or in lactation Patient with any lipid regulating agents within 4 weeks prior to study period Patient currently taking concomitant medications, such as oral contraceptives, or any medical treatment capable of interfering with lipid metabolism(eg thiazides, β-blockers, cyclosporins, itraconazole erythromycin,and danazol) Patient with medical history of hypothyroidism, pancreatitis, cholestasis, nephrotic syndrome, gall bladder disease, primary biliary cirrhosis. Patient with liver dysfunction (SGOT or SGPT>2x ULN) Patient with renal insufficiency (serum creatinine>1.3mg/dL) Patient with myocardial infarction,cerebrovascular disease,or major operations within 6 months prior to the study period.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lipid-lowing Tea|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Use of Drugs and Constipation in Nursing Homes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study factors (drugs, serum concentration of drugs, nutrition, physical activity, demographics, diseases etc.) related to constipation and diarrhea in nursing homes, and the effect of different laxative regimens.

Official Title
-----------------
Use of Drugs and Constipation in Nursing Homes

Conditions
-----------------
Constipation, Diarrhea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Above 60 years old Stayed in nursing homes for more than 8 weeks Informed consent Exclusion Criteria: Expected discharge within 2 weeks Organic disorders causing constipation and diarrhea

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Constipation | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of constipation |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aged, Polypharmacy, Adverse effects, Nursing homes
Study Evaluating Renal Cell Carcinoma Risk Factors

Study Overview
=================
Brief Summary
-----------------
This is an epidemiological, prospective, multicenter study designed to identify the pre-treatment clinical, molecular and genetic prognostic factors associated with progression free survival in patients naïve to renal cell carcinoma (RCC) treatment.

Detailed Description
-----------------
invitation to volunteer

Official Title
-----------------
Prospective, Multicenter, Epidemiological Study To Determine The Clinical, Molecular And Genetic Factors Associated To The Prognosis Of Patients With Advanced Renal Cell Carcinoma

Conditions
-----------------
Carcinoma, Renal Cell

Intervention / Treatment
-----------------
* Other: Epidemiological study according to clinical practice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treatment naïve patients with proven advanced RCC will be evaluated. (Except surgery or radiotherapy) =18 years, any gender. Patients with advanced Renal Cell Carcinoma and treatment naïve. Exclusion Criteria: Patients who have already initiated any kind of specific therapy for the treatment of RCC.2. Patients with other neoplasias different from RCC (current or past).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br> | Other: Epidemiological study according to clinical practice<br>* Epidemiological study according to clinical practice.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate. |  | 12 months | 
| Overall survival. |  | 12 months |
A Study on the Pharmacokinetics and Safety of Valcyte (Valganciclovir) in Pediatric Heart Transplant Recipients Less Than 4 Months of Age

Study Overview
=================
Brief Summary
-----------------
This open label study will assess the pharmacokinetics and the safety and tolerability of Valcyte (valganciclovir) powder for oral solution in neonatal and infant heart transplant patients < 4 months of age.

Official Title
-----------------
Pharmacokinetics and Safety of Valganciclovir in Pediatric Heart Transplant Recipients < 4 Months of Age

Conditions
-----------------
Cytomegalovirus Infections, Heart Transplantation

Intervention / Treatment
-----------------
* Drug: valganciclovir [Valcyte]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females, 0 to < 4 months (< 125 days) of age at the time of the last PK assessment in this study Parent or guardian of the patient is willing and able to give written informed consent Patient has received a first heart transplant Patient is at risk of developing cytomegalovirus (CMV) disease and is being treated with i.v. ganciclovir or oral valganciclovir for prevention of CMV Adequate hematological and renal function Able to tolerate oral medication (any appropriate form of tube feeding is acceptable) Exclusion Criteria: Allergic or significant adverse reaction to acyclovir, valacyclovir or ganciclovir in the past Severe, uncontrolled, clinically abnormal diarrhea Liver enzyme elevation of more than five times the upper limit of normal for AST (SGOT) or ALT (SGPT) Patient requires use of any protocol prohibited concomitant medications Patient has previously participated in this clinical trial

Ages Eligible for Study
-----------------
Maximum Age: 124 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br> | Drug: valganciclovir [Valcyte]<br>* oral dose, Days 1 and 2<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under plasma concentration versus time curve of ganciclovir |  | 0, 1-3, 3-7, 7-12, 24 hours post-dose | 
| Apparent volume of distribution of ganciclovir |  | 0, 1-3, 3-7, 7-12, 24 hours post-dose | 
| Terminal half-life of ganciclovir |  | 0, 1-3, 3-7, 7-12, 24 hours post-dose | 
| Peak concentration of ganciclovir |  | 0, 1-3, 3-7, 7-12, 24 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (Incidence of adverse events) |  | 9 days |
Genetic Predisposition of Coronary Artery Disease -- The COROGENE-Study

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to identify genetic loci,or gene variations contributing to inflammation and to the development of CHD. We will compare coronary angiogram results to genetic findings within coronary artery disease patients and in patients with normal coronaries.

Detailed Description
-----------------
Coronary artery disease (CAD) is a chronic inflammatory disease, progression of which may be accelerated by immunological mechanisms. Genes involved in regulation of inflammation and protection against infectious agents may affect picture of the disease . Major Histocompatibility Complex (MHC) region carries genes involved in innate and adaptive immunity and inflammation. We have for the first time, identified genetic factors located in HLA region, showing several fold risk for disease predisposition likely forming an important component to explain the high incidence of coronary heart disease in the Finnish population. The aim of this study is to rerun our preliminary results, and further identify genetic loci, or gene variations contributing to the development of CHD. The strategy is to collect altogether 5000 patients assigned to coronary angiogram in Helsinki University Central Hospital. We will compare the angiogram results to genetic findings first in patients with normal coronaries, and in patients with different stages of CHD. Secondly we will compare phenotypic changes in inflammation and try to find out if the phenotype differs in different genotypes. Thirdly we will collect patients from hospital discharge registry, and compare mortality and morbidity results in different gene groups. Finally, we aim to record echocardiograms of the aortic valves in altogether 3500 consecutive patients undergoing coronary angiography. We try to identify genetic loci and gene variations contributing to the fibrosis and calcification of the aortic valve. The results of the study provide a possibility to develop a gene test to recognize patients at risk at its early stage, and needing for preventive medicine.

Official Title
-----------------
Genetic Predisposition of Coronary Artery Disease in Patients Verified With Coronary Angiogram The COROGENE-Study

Conditions
-----------------
Coronary Disease, Inflammation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient assigned to coronary angiogram Exclusion Criteria: Inability to give informed consent
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary Disease, Inflammation, Genetics, HLA Antigens, Aortic Valve