linjc16/ctgov huggingface dataset:
Genetic and Environmental Determinants of Hypertension

Study Overview
=================
Brief Summary
-----------------
To determine the pathophysiology of different types of essential hypertension by identifying the discrete effects of major genes and environmental variables as determinants of the subtypes of essential hypertension.

Detailed Description
-----------------
BACKGROUND: Essential hypertension is believed to be a heterogeneous group of disorders, the subtypes of which could be related to sodium sensitivity, obesity, diabetes, calcium intake and metabolism, the renin-angiotensin balance, or membrane cation transport. Essential hypertension aggregates in families. The syndromes leading to hypertension may involve shared genes, shared environmental factors, or both. DESIGN NARRATIVE: In 1980 a series of biochemical and physiological tests were initiated in the 2,548 persons in 98 extended pedigrees in Utah. Most of the subjects were obtained from three major pedigree types: stroke cluster pedigrees; coronary heart disease cluster pedigrees; and pedigrees of Utah Hypertension Detection and Follow-up Program high blood pressure probands. Data were collected on personal history, medical family history and genealogy, anthropometrics, standard and 32-lead electro- cardiograms, multiple blood pressure measurements during sitting, standing, lying, tilting, isometric hand grip exercise, bicycle exercise, venipuncture and mental arithmetic. Cation tests included sodium-lithium countertransport, lithium-potassium co-transport, intracellular sodium, potassium, magnesium, sodium-potassium ATP-ase pump activity and binding sites and plasma levels of sodium, potassium, magnesium, ionized calcium and digoxin-like pump inhibitor. Information was also collected on stress, exercise, plasma renin activity, and urinary kallikrein. Statistical and pedigree analysis were conducted. The same tests were also performed on 600 new population-based hypertensive subjects on drug therapy and again four months after interruption of drug therapy. Tests were conduced for specific subtypes of high blood pressure among the 600 subjects using individual variables and multivariate combinations of variables. Three hundred nuclear families were screened to test for familiality of subtype indicators and to identify those high blood pressure subtype indicator variables needing detailed pedigree analysis. One thousand sequentially-sampled persons were studied for major genes, DNA probe linkage, and gene-environment interactions as determinants of specific types of hypertension.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Site Selection of Short Peripheral Venous Catheters

Study Overview
=================
Brief Summary
-----------------
Up to 90% of catheters fail before therapy is complete. Improved dwell time of intravenous catheters for even small increments of time would further reduce the number of insertions, staff workloads, and costs. In this study, the investigators investigated whether short peripheral venous catheter site of insertion influence the dwell time.

Official Title
-----------------
Site Selection of Peripheral Venous Access Via Short Peripheral Catheters in Adult Patients (SPECIAL Trial)

Conditions
-----------------
Short Peripheral Venous Catheter

Intervention / Treatment
-----------------
* Device: short peripheral venous catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years Expected duration of infusion therapy by short peripheral intravenous catheters >7 days Give written informed consent Exclusion Criteria: The peripheral venous catheter was inserted in emergency room or in emergency circumstances Bloodstream infection Had a peripheral venous catheter already in situ at the baseline Altered mental state

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dorsum of hand group<br>short peripheral venous catheter place in the dorsum of the hand | Device: short peripheral venous catheter<br>* short peripheral venous catheter for infusion therapy in adult patients<br>|
| Experimental: Forearm group<br>short peripheral venous catheter place in the forearm | Device: short peripheral venous catheter<br>* short peripheral venous catheter for infusion therapy in adult patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Indwelling time |  | from the cannulae insertion until its removal, usually within 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phlebitis |  | from the cannulae insertion until its removal, usually within 2 weeks | 
| Occlusion of the catheter |  | from the cannulae insertion until its removal, usually within 2 weeks | 
| Infiltration |  | from the cannulae insertion until its removal, usually within 2 weeks | 
| Accidental catheter removal |  | from the cannulae insertion until its removal, usually within 2 weeks | 
| Local venous infection |  | from the cannulae insertion until its removal, usually within 2 weeks | 
| Catheter-related bloodstream infection |  | from the cannulae insertion until its removal, usually within 2 weeks |
Adalimumab Trough Concentrations in Crohn's Disease: A Pilot Pharmacokinetic Study

Study Overview
=================
Brief Summary
-----------------
Observational pharmacokinetics study of adalimumab in patients with active refractory Crohn's disease who are naïve to TNF antagonist therapy.

Detailed Description
-----------------
Adalimumab (ADM), a fully human tumor necrosis factor (TNF) antagonist, is effective for treating patients with Crohn's disease (CD). A correlation between concentration and effect was observed at distinct time points. The aim was to evaluate the correlation of early longitudinal measurements of ADM with different biological markers for disease activity and induction and maintenance of clinical remission. This is a prospective two-center open-label observational study in anti-TNF naïve patients with moderate to severe CD induced with ADM 160/80 mg at week 0 and 2 and 40 mg every 2 weeks in monotherapy. All patients should be in need for TNF antagonist therapy and should fulfill standard reimbursement criteria (Belgium). Serum samples were taken pre and post first injection and at weeks 1, 2, 3, 4, 12, 26 and 52. Following parameters were determined: C-reactive protein, albumin, TNF, ADM, antibodies to ADM, hemoglobin, platelet count and leukocyte count. Clinical response and remission was evaluated using the Harvey-Bradshaw index.

Official Title
-----------------
Adalimumab Trough Concentrations in Crohn's Disease: A Pilot Pharmacokinetic Study

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Drug: Adalimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with confirmed diagnosis of Crohn's disease, fulfilling the criteria for reimbursement (Belgium). Patients with active disease defined as a Harvey-Bradshaw index >4 and/or a C-reactive protein concentration >5 mg/l. Informed consent. Exclusion Criteria: Patients with ulcerative colitis. Patients treated in placebo controlled trials. Patients unwilling to participate or withdrawing informed consent for this study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Single-group study<br>Subjects with active refractory Crohn's disease naïve to TNF antagonists starting adalimumab therapy. | Drug: Adalimumab<br>* 160 mg at week 0, 80 mg at week 2 and 40 mg every two weeks onwards<br>* Other names: Humira;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients in clinical remission | As defined by a Harvey-Bradshaw index ≤4 | week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adalimumab, anti-TNF, pharmacokinetics, trough level, immunogenicity
Prevalence of Asthma and Rhinitis Symptoms Among Secondary School Students in Saudi Arabia

Study Overview
=================
Brief Summary
-----------------
The purpose of this cross-sectional survey study is to describe the prevalence of asthma and Rhinitis symptoms among secondary school students in Saudi Arabia.

Detailed Description
-----------------
Cross sectional survey based on ISAAC protocol to characterize the symptoms of asthma and rhinitis and measure their frequency and its prevalence among secondary schools students (age 15 to 18 years, boys and girls) in Riyadh city, Saudi Arabia in period from 1st of April 2010 to 31st of May 2010. The ISAAC protocol stated that the study population should consist of at least 3,000 students aged 15-18 years- in this case, enrolled in at least 40 randomly selected schools. The 15-18 year age group was chosen because it is the age most adolescents go to school regularly, making data collection easier. Once requested by the research team, the education authority will provide a list of all secondary schools in Riyadh city and the number of students by school and their grades. There are 400 secondary schools for boys and 400 school for girls (total number of boys and girls students 50,000). A two stage stratified random sample of 4000 students will be selected out of secondary schools for boys and girls , Their ages range from 16 to 18 years.

Official Title
-----------------
Prevalence of Asthma and Rhinitis Symptoms Among Secondary School Students in Saudi Arabia

Conditions
-----------------
Asthma, Rhinitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 15:18 year age group Exclusion Criteria: Younger than 15 years or older than 18 years

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 18 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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
-----------------
prevalence of asthma and Rhinitis symptoms among secondary school students in Saudi Arabia
Use of Tinzaparin for Anticoagulation in Hemodialysis

Study Overview
=================
Brief Summary
-----------------
The HEMO-TIN trial is designed to look at both the safety (bleeding risk) and effectiveness (clotting risk) of tinzaparin compared with unfractionated heparin for anticoagulation in hemodialysis patients.

Official Title
-----------------
Intermittent HEMOdialysis Anticoagulation With TINzaparin Versus Unfractionated Heparin: A Pilot Multicentre Randomized Controlled Trial (HEMO-TIN Trial)

Conditions
-----------------
Kidney Failure, Chronic

Intervention / Treatment
-----------------
* Drug: Tinzaparin
* Drug: Unfractionated Heparin
* Drug: Placebo (for Tinzaparin)
* Drug: Placebo (for Unfractionated Heparin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >= 18 years End stage renal disease maintained on outpatient hemodialysis for >= 3 months Frequency of hemodialysis: 3 times per week Anticoagulation with an unfractionated heparin protocol for at least 4 weeks Patient or legal guardian able to provide written consent Baseline INR <= 1.3 Baseline platelet count >= 80,000 x 10^9/L Exclusion Criteria: Therapeutic systemic anticoagulation Clinically apparent bleeding in the last 2 months High risk of bleeding Planned major surgery in the next 4 months Major surgery in the past 48 hours Pregnant or lactating Child bearing potential Allergy/intolerance to heparin or history of heparin induced thrombocytopenia Current participation in a related randomized drug trial

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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tinzaparin<br> | Drug: Tinzaparin<br> <br> * Other names: Innohep;Drug: Placebo (for Unfractionated Heparin)<br>* 0.9% Normal Saline<br>|
| Active Comparator: Unfractionated Heparin<br> | Drug: Unfractionated Heparin<br> <br> * Other names: Heparin LEO;Drug: Placebo (for Tinzaparin)<br>* 0.9% Normal Saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of major, clinically important non-major or minor bleeding |  | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clotting in extracorporeal dialysis circuit |  | During Hemodialysis (weekly for 26 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemodialysis, Anticoagulation, Tinzaparin, Unfractionated Heparin, Randomized Controlled Trial
Add-on Sodium Nitroprusside to Treatment as Usual in Schizophrenia

Study Overview
=================
Brief Summary
-----------------
In spite of the numerous studies on schizophrenia, its etiology and physiopathology remain unknown. Evidence suggests a possible implication of nitric oxide (NO) in schizophrenia. NO is a gas with unique chemistry and influences the release of neurotransmitters, learning, memory and neurodevelopment. Recent studies that investigated the role of NO in patients with schizophrenia found evidence that points to a disruption in NO-mediated neurotransmission in schizophrenia. Accordingly, we believe that the administration of sodium nitroprusside, an NO donor, will ameliorate schizophrenia symptoms.

Official Title
-----------------
Randomised Double Blind Placebo Controlled Study of Sodium Nitroprusside Added to Treatment as Usual in Patients With Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Sodium nitroprusside
* Drug: Glucose solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of schizophrenia Patients in an acute psychotic episode requiring full hospitalization Exclusion Criteria: Significant medical conditions (heart, kidney, liver, thyroid or neurological diseases, hypovitaminosis B12, hyponatremia) Pregnancy Breastfeeding Previous hypersensitivity to sodium nitroprusside DSM-IV diagnosis of drug abuse or dependence

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sodium nitroprusside<br> | Drug: Sodium nitroprusside<br>* Intravenous infusion of 0,5 mcg/kg/min for 240 minutes<br>|
| Placebo Comparator: Placebo<br>Glucose solution 5% | Drug: Glucose solution<br>* Intravenous infusion of glucose solution 5% for 240 minutes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BPRS score | Brief Psychiatric Rating Scale | baseline and up to 4 weeks | 
| Change in PANSS negative subscale score | Positive and Negative Syndrome Scale | Every hour for 4 hours, then at +12h, then daily for 7 days, then weekly for 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive assessment | FAS, 2-back, Stroop Color Word Test | Baseline and after 12 h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, Nitric oxide, Sodium nitroprusside
STA-9090 for Treatment of AML, CML, MDS and Myeloproliferative Disorders

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterize the safety and efficacy of STA-9090 (ganetespib) in subjects with hematologic malignancies.

Official Title
-----------------
A Phase 1 Study of the HSP90 Inhibitor, STA-9090, Administered Twice Weekly in Subjects With Hematologic Malignancies

Conditions
-----------------
AML, CML, MDS, Myeloproliferative Disorders

Intervention / Treatment
-----------------
* Drug: STA-9090 (ganetespib)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Males and females 18 years or older Eligible subjects must have one of the following relapsed or refractory hematologic malignancies: AML, MDS, CML, or myeloproliferative disorders as defined in the protocol Must have acceptable organ function during screening as defined in the protocol Exclusion Criteria Pregnant or breast-feeding women Patients must meet the washout periods for prior chemotherapies and radiation History of stroke within 6 months of treatment Poor venous access for study drug administration Treatment with chronic immunosuppressants Other severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort<br> | Drug: STA-9090 (ganetespib)<br>* Chemotherapy agent<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the safety and tolerability of STA-9090 (ganetespib) in subjects with hematologic malignancies |  | Feb 2011 | 
| To assess preliminary evidence of anti-neoplastic activity |  | Feb 2011 | 
| To assess the pharmacokinetics of STA-9090 (ganetespib) when administered as a short-term intravenous infusion |  | Feb 2011 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess changes in biomarkers following study drug administration |  | Feb 2011 | 
| To investigate drug exposure levels/plasma concentrations and correlations with efficacy and safety parameters |  | Feb 2011 | 
| To assess the impact of variations in drug metabolizing enzymes (DME pharmacogenomics) on the pharmacokinetics of STA-9090 (ganetespib) |  | Feb 2011 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Synta, STA-9090, AML, CML, MDS, myeloproliferative disorder, hematologic malignancy, ganetespib
Androgen Replacement Therapy in Women With Hypopituitarism

Study Overview
=================
Brief Summary
-----------------
This is a study to determine whether testosterone replacement with TheraDerm can improve bone density, mood, sex drive, thinking, and distribution of body fat and muscle mass in women with hypopituitarism.

Detailed Description
-----------------
Patients will be randomized into 2 groups to receive testosterone replacement therapy or placebo. Group 1 will receive 2 testosterone patches and estrogen pills for 12 months. Group 2 will receive 2 placebo patches and estrogen pills for 12 months. Changes in bone density, bone metabolism markers, body composition, libido, and quality of life will be compared in the women receiving testosterone replacement therapy with that of the women receiving placebo. Completion date provided represents the completion date of the grant per OOPD records

Official Title
-----------------
TheraDerm Administration in Women With Hypopituitarism

Conditions
-----------------
Hypopituitarism

Intervention / Treatment
-----------------
* Drug: TheraDerm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Hypogonadism and/or hypoadrenalism of central origin Testosterone or free testosterone level below the median for age-matched normal controls Prior estrogen preparation for at least 6 months Exclusion criteria: Any disease known to affect bone metabolism, including untreated hypothyroidism or hyperthyroidism Change in thyroid hormone dose in the last 3 months Untreated Cushing's syndrome Renal failure Alcoholism Anorexia nervosa Prior use of medication known to affect bone metabolism (e.g., supraphysiologic doses of glucocorticoids, phenytoin, bisphosphonates, or calcitonin) within the past 3 months Pregnant or nursing Uncontrolled hypertension ALT greater than 3 times upper limit of normal Serum creatinine greater than 2 times the upper limit of normal Any contraindication to estrogen therapy, including history of breast cancer or undiagnosed uterine bleeding Concurrent growth hormone replacement therapy, if patient has been receiving it for less than 2 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

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 |
| --- |
|Drug: TheraDerm|nan|

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

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