linjc16/ctgov huggingface dataset:
Fasturtec TLS Treatment / Prophylysis

Study Overview
=================
Brief Summary
-----------------
An open-label study to determine the efficacy and safety of Rasburicase used for the prevention and treatment of tumor lysis syndrome

Official Title
-----------------
A Multicenter Open Label Study of the Efficacy and Safety of Rasburicase in the Treatment of Prophylysis for Tumor Lysis Syndrome

Conditions
-----------------
Tumor Lysis Syndrome

Intervention / Treatment
-----------------
* Drug: urate oxidase


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chemotherapy planned for at least 3 cycles Undergoing cytoreductive chemotherapy for ALL, multiple myeloma or Burkitt's lymphoma stage III or IV With a minimum life expectancy of 3 months Uric acid > 8 mg% Negative pregnancy test < or =to 2 weeks and efficient contraceptive method. Negative HIV serology < or =to 4 weeks Patient or legal guardian has signed a written informed consent Exclusion Criteria: Hypersensitivity to uricases or any of the excipients Known history of G6PD deficiency. Previous treatment with Rasburicase or Uricozyme® Pregnancy or lactation Treatment with any investigational drug within 30 days before planned first Rasburicase administration

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: urate oxidase|First injection of Rasburicase will be done the day of initiation of chemotherapy, or the day before, according to hyperuricemia. Additional doses are permitted q12h during the first 72 hours of chemotherapy if hyperuricemia persists or subject is considered to be at significant risk of tumor lysis complications.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the uricolytic response to rasburicase treatment |  | 5 weeks (3 to 7 days of treatment, with follow-up of 4 weeks after the last study drug injection) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate tumor lysis risk factors, treatments for tumor lysis syndrome and complications of treatment in patients treated prophylactically or therapeutically for tumor lysis syndrome |  | 5 weeks (3 to 7 days of treatment, with follow-up of 4 weeks after the last study drug injection) |
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone Replacement for Primary Adrenal Insufficiency

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the efficacy of dehydroepiandrosterone (DHEA), an androgen replacement hormone, for patients with primary adrenal insufficiency (Addison's disease).

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by age. Patients are randomly assigned to androgen replacement therapy with daily dehydroepiandrosterone (DHEA) or placebo for 6 months. All patients may receive 6 additional months of DHEA following randomized therapy. Women on hormonal replacement therapy may receive concurrent conjugated estrogens or oral medroxyprogesterone.

Conditions
-----------------
Addison's Disease

Intervention / Treatment
-----------------
* Drug: dehydroepiandrosterone


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Primary adrenal insufficiency (Addison's disease) Serum dehydroepiandrosterone less than 0.5 nmol/L --Prior/Concurrent Therapy-- No concurrent investigational drug Stable glucocorticoid/mineralocorticoid dose over past year required --Patient Characteristics-- Hepatic: No hepatic disease Cardiovascular: No vascular disease No thrombotic disorder No angina No elevated blood pressure on 2 readings taken 15 minutes apart in 1 visit, i.e.: Systolic greater than 165 mm Hg OR Diastolic greater than 95 mm Hg Other: No clinically significant medical abnormality No gallbladder disease No malignancy No estrogen- or androgen-dependent neoplasia Benign prostatic hyperplasia eligible No other endocrine disease Controlled thyroid disease with normal thyroid-stimulating hormone eligible Mammogram required within 1 year prior to entry for women aged 40 and over No clinically significant abnormality No undiagnosed vaginal or uterine bleeding within 6 months prior to entry Pap smear required within 1 year prior to entry No dysplasia (squamous intraepithelial lesion low-grade or higher)

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: dehydroepiandrosterone|nan|

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
-----------------
Addison's disease, endocrine disorders, rare disease, primary adrenal insufficiency
Study of the Natural History and Genotype-Phenotype Correlations of Hereditary Hemorrhagic Telangiectasia Patients

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Collect data regarding the natural history of hereditary hemorrhagic telangiectasia (HHT). II. Establish genotype-phenotype correlations in HHT. III. Create a database of information for researchers throughout the world.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients complete a self-administered natural history questionnaire in a multiple choice format. Questionnaire is completed by a population consisting of males and females of all ages and ethnic backgrounds. Data are collected and made available to all researchers.

Conditions
-----------------
Hereditary Hemorrhagic Telangiectasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Diagnosed hereditary hemorrhagic telangiectasia (Osler-Rendu-Weber disease) with recurrent epistaxis, telangiectases, and visceral vascular anomalies

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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
-----------------
genetic diseases and dysmorphic syndromes, hematologic disorders, hereditary hemorrhagic telangiectasia, rare disease
Homburg Cream & Sugar Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to prospectivly analyze the correlation of triglyceride tolerance and glucose tolerance with cardiovascular morbidity and mortality in patients with stable coronary artery disease within 18 months and to determine, whether measurement of triglyceride tolerance can discriminate patients at risk for cardiovascular events.

Official Title
-----------------
Prospective Investigation of the Influence of Triglyceride Tolerance on Cardiovascular Outcomes in Patients With Coronary Artery Disease

Conditions
-----------------
Coronary Artery Disease, Diabetes, Metabolic Syndrome, Glucose Tolerance, Hyperlipidemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable CAD Exclusion Criteria: Acute Coronary Syndrom Relevant Arrhythmias Severe valvular heart disease Decompensated heart failure Severe inflammtory disease (infectious, rheumatoid) Metabolic diseases (e.g. thyroid) Inability to swallow Liver or kidney failure Lactose intolerance Fat intolerance (e.g. chronic pancreatitis, gall stones) Malignant Disease Psychiatric Diseases (including alcohol / drug abuse) Pregnancy

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>> 500 consecutive patients with coronary artery disease fulfilling eligibility criteria. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parameters of triglyceride tolerance and glucose tolerance in correlation to cardiovascular events, cardiovascular mortality, total mortality. |  | 48 months after inclusion. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist-to-Hip ratio, nutrition protocol, physical activity, non-invasive endothelial function, body fat composition, other biomarkers of lipid and glucose metabolism. |  | Directly after inclusion. |
Evaluation of Manufacturing Lot of StaphVAX

Study Overview
=================
Brief Summary
-----------------
This study answers a U.S. Food and Drug Administration requirement for evaluation in people of a manufacturing lot of vaccine. Subjects receive one dose of one lot of vaccine. The antibodies in the blood measure the immunogenicity of the vaccine, and typical vaccine safety information is also collected.

Official Title
-----------------
A Phase 3, Multicenter, Open-Label, Historical Comparative Study to Evaluate Immunogenicity and Safety of a Commercial Lot of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Adults on Hemodialysis

Conditions
-----------------
Staphylococcal Infections, Chronic Kidney Failure

Intervention / Treatment
-----------------
* Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 8 wk of hemodialysis for ESRD, have written informed consent, a negative serum pregnancy test if appropriate, and expect to comply with protocol procedures and schedule Exclusion Criteria: known HIV, immunomodulatory drugs, malignancy (other than basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or early stage prostate cancer), active infection in the 2 weeks prior to study injection, serious S. aureus infection within the last 3 months prior to injection, use of investigational drugs, vaccines or devices within the prior 30 days, hypersensitivity to components of StaphVAX

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vaccine<br>single dose of StaphVAX in hemodialysis patients | Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Vaccine<br>* single IM dose totalling 200 mcg of conjugate<br>* Other names: StaphVAX®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type-specific antibody concentrations |  | 6 weeks after vaccine dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type-specific antibody concentrations |  | 3 weeks after vaccine dose | 
| Elicited vaccine reactogenicity. |  | daily for 7 days after dose |
Flat OGTT (Oral Glucose Tolerance Test) During Pregnancy

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to examine the relationship between flat sugar curve on OGTT-glucose tolerance test during pregnancy, neonatal birthweight and other perinatal outcomes.

Detailed Description
-----------------
A retrospective cohort analysis of all women delivered in one university affiliated medical center between January 1st 2018 and December 31th 2019 with documented 100 grams OGTT results.

Official Title
-----------------
The Flat OGTT During Pregnancy -Prevalence and Risk for Adverse Outcomes

Conditions
-----------------
Pregnancy Related

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Performing the OGTT test during the pregnancy Exclusion Criteria: lack of documentation or Non-performance of OGTT test during the pregnancy.

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

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

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 |
| --- | --- | --- |
| To evaluate the characteristics and perinatal outcomes of parturients with a flat glucose curve on 100 grams oral glucose tolerance test (OGTT). | A flat OGTT curve occurs in a younger, leaner population. Although flat OGTT can possibly reflect some degree of hyperinsulinemia, it is generally not associated with adverse maternal or neonatal outcomes. | 10 months |
Impact of Weight Loss Surgery in Adolescents With NAFLD

Study Overview
=================
Brief Summary
-----------------
This study will assess the impact of weight loss surgery (WLS) on non-alcoholic fatty liver disease (NAFLD) in adolescents as well as the interaction between NAFLD and cardiometabolic risk.

Detailed Description
-----------------
While the impact of WLS has been studied in adults, little is known about NAFLD in adolescents undergoing WLS. At present, only a small number of adolescents undergo WLS each year and thus this area has not been well studied. However, as the prevalence of severe obesity continues to rise the investigators anticipate that so will WLS in adolescents. This study will establish the impact of WLS on NAFLD in adolescents. Currently, it is assumed that adolescents with NAFLD diagnosed at the time of WLS have universal resolution of their disease with appropriate weight loss, and no further evaluation is conducted. Our group has shown that up to 40% of adolescents who undergo WLS have persistently abnormal aminotransferase levels, suggesting that many may have persistent NASH and are at risk of progressive liver disease. The study will elucidate the history of NAFLD following WLS. Such data have not been previously published and will represent a significant contribution to this field.

Official Title
-----------------
The Impact of Weight Loss Surgery in Adolescents on Fatty Liver Disease

Conditions
-----------------
NAFLD, Obesity, Adolescent

Intervention / Treatment
-----------------
* Other: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obese Meets institutional requirements for weight loss surgery Exclusion Criteria: Alcohol consumption or other causes of chronic liver disease Intolerance to MRI Weight >435 lbs

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 22 Years

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: MRI for steatosis assessment<br>Abdominal MRI for assessment of hepatic steatosis | Other: MRI<br>* MRI to assess hepatic steatosis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hepatitis steatosis after weight loss surgery | Change in hepatitis steatosis after weight loss surgery as measured by MRS | 7 months |
The Effect of Pneumoperitoneum and Trendelenburg Position on Intracranial Pressure: Ultrasonographic Measurement of Optic Nerve Sheath Diameter

Study Overview
=================
Brief Summary
-----------------
The steep Trendelenburg position and pneumoperitoneum during laparoscopic surgery have the potential to cause an increase of intracranial pressure (ICP). Previous studies have proposed that ultrasonographic measurements of the optic nerve sheath diameter (ONSD) correlate with signs of increased ICP. Therefore, this study is aim to confirm the increased ICP by ultrasonographic measurement of ONSD during laparoscopic surgery.

Conditions
-----------------
Robot-assisted Laparoscopic Prostatectomy Under General Anesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (20-90 years of age) scheduled for undergoing robot-assisted laparoscopic prostatectomy undergoing general anesthesia Exclusion Criteria: Patients with previous history of neurologic disease, carotid disease, transient ischemic attack, ocular disease and ocular surgery

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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 |
| --- | --- |
| Patients undergoing robot-assisted laparoscopic prostatectomy<br>Patients undergoing robot-assisted laparoscopic prostatectomy under general anesthesia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ultrasonographic measurement of optic nerve sheath diameter | A thick layer of gel is applied on the upper closed eyelid. The linear 13- to 6-MHz ultrasound probe is then placed in the gel, without exerting pressure on the eye. Two measurements are taken for each optic nerve: one in the transverse plane, with the probe being horizontal, and one in the sagittal plane, with the probe being vertical. The final ONSD is the mean of these measurements. | before anesthesia induction, 10 minutes after anesthesia induction, 30 minutes after steep trendelenburg position and pneumoperitoneum, and 10 minutes after supine position, CO2 desufflation. |
Metformin to Prevent Metabolic Complications in Glucocorticoid Excess

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate if a treatment with metformin compared to placebo reduces metabolic side-effects in patients with glucocorticoid treatment over three months time.

Official Title
-----------------
Metformin to Prevent Metabolic Complications in Glucocorticoid Excess

Conditions
-----------------
Patients With Glucocorticoid Treatment

Intervention / Treatment
-----------------
* Drug: Metformin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Glucocorticoid treatment for ≥ 3 months with a prednisone dose of ≥ 7.5mg/d or equivalent glucocorticoid Exclusion Criteria: Refusal of informed consent Prior therapy with metformin during the last 6 month Preexisting diabetes Pregnancy or current malignancy Renal insufficiency with a creatinine clearance lower than 30ml/min

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metformin<br> | Drug: Metformin<br>* Volunteers will be given Metformin or placebo for 1 month, once daily.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Volunteers will be given Metformin or placebo for 1 month, once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2 hours glucose level after a standardized 75g oral glucose tolerance test (OGTT) |  | 0 months, 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| homeostasis model assessment (HOMA)-index |  | 0 months, 3 months |
Induction of Migraine Aura With Sildenafil

Study Overview
=================
Brief Summary
-----------------
In a double blind placebo-controlled cross-over study the effect of Sildenafil on aura and migraine headache induction is tested in patient with migraine with aura.

Official Title
-----------------
The Effect of the Selective PDE5 Inhibitor, Sildenafil, on Aura and Migraine Headache Induction.

Conditions
-----------------
Migraine With Aura

Intervention / Treatment
-----------------
* Drug: Sildenafil
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Migraine with aura Minimum of 2 attacks/year Exclusion Criteria: Any other type of headache, except tension-type headache < 4 days per month History of cardio- or cerebrovascular diseases Hypertension or hypotension Any daily intake of medication, including prophylactic migraine treatment, except oral contraceptives Pregnancy and lactation

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Sildenafil 100 mg single dose | Drug: Sildenafil<br>* Single oral administration of active or placebo one week apart<br>|
| Placebo Comparator: Placebo<br>Placebo capsule | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aura and migraine like headache | Induction of aura reported by an aura diary for 14 hours post medication | 14 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Markers of endothelial function in blood |  | 2 hours | 
| Migraine without aura | Induction of headache resembling usual migraine attacks | 14 hours |