linjc16/ctgov huggingface dataset:
Apomorphine Nasal Powder in the Treatment of Parkinson's Disease Off Periods.

Study Overview
=================
Brief Summary
-----------------
To determine the safety and tolerability of repeated dosing with Apomorphine Nasal Powder in subjects with Parkinson's Disease.

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: Apomorphine Nasal Powder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1 year history of Parkinson's Disease; stable PD medications for 4 weeks; at least one documented off period per day Exclusion Criteria: hypersensitivity to apomorphine; participation in a clinical trial in the last 12 weeks; pregnant or lactating females

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Interventional Model Description: 3-week, double-blind, placebo-controlled, 3 × crossover efficacy phase followed by 12 week open label phase, followed by 36 week open continuation phase
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Apomorphine Nasal Powder|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
DPBRN Development of a Patient Based Provider Intervention for Early Caries Management

Study Overview
=================
Brief Summary
-----------------
This study focused on improving the quality of dental care by fostering movement of the latest scientific advances into daily clinical practice.

Detailed Description
-----------------
Phase 1 - development of two instruments (a patient brochure that described non-invasive caries treatment and a patient questionnaire of satisfaction with non-invasive caries treatment). Phase 2 - field tested the patient brochure Phase 3 - pilot tested the patient brochure, quantifying patient satisfaction with non-invasive caries treatments and a feasibility study that will inform the design of a clinical trial in dental practices envisioned for a later study.

Official Title
-----------------
Development of a Patient Based Provider Intervention for Early Caries

Conditions
-----------------
Dental Caries

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: dentists enrolled in the Dental Practice-Based Research Network (DPBRN) who participated in DPBRN Assessment of Caries Diagnosis & Caries Treatment and DBPRN Reasons for placing the First Restoration on Permanent Tooth Surfaces Exclusion Criteria: patients under 19 years of age

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| intervention<br>design instruments and test feasibility of an intervention aimed at increasing the proportion on non-invasive treatment for early caries | |

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
-----------------
Dental Caries, Intervention, Non-invasive treatment for early caries
Hour-specific Transcutaneous Bilirubin in Healthy Term and Near-term Newborns of China

Study Overview
=================
Brief Summary
-----------------
Make a neonatal jaundiced nomogram on Chinese jaundice data by joinning the major neonate centers all around China.

Detailed Description
-----------------
Jaundice in common amount Chinese newborn population. The neonatal jaundice guildline was made base on the AAP. guideline. Chinese newborn have their jaundice follow up and treatment plans make base on American neonatel jaundice data. Our group are now planning to have our own neonatel jaundice data by joinning the major neonate centers all around China. A neonatal jaundiced nomogram would be made base on Chinese neonatel jaundice data.

Official Title
-----------------
Hour-specific Transcutaneous Bilirubin in Healthy Term and Near-term Newborns of China

Conditions
-----------------
Jaundice, Neonatal

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: gestational age more than 35 weeks(≥35) - Exclusion Criteria: all kinds of congenital diseases, infants with pathologic jaundice -

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 7 Days

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 |
| --- | --- | --- |
| Hour-specific Transcutaneous Bilirubin Level | make neonatal jaundiced nomogram base on the hour-specific transcutaneous bilirubin data | 1 year |
Phase I Study of Ex Vivo Liver-Directed Gene Therapy for Familial Hypercholesterolemia

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Develop an approach for treating patients with homozygous familial hypercholesterolemia using gene therapy with autologous hepatocytes transduced with a normal low-density lipoprotein receptor gene.

Detailed Description
-----------------
PROTOCOL OUTLINE: Autologous hepatocytes are obtained from a partial hepatectomy and transduced with a recombinant retroviral vector containing the low-density lipoprotein receptor gene. The transduced hepatocytes are infused via the inferior mesenteric vein 3 days following surgery. Traditional therapy is discontinued for 4 weeks prior to protocol therapy and may resume 6 weeks after the hepatocyte infusion.

Conditions
-----------------
Familial Hypercholesterolemia

Intervention / Treatment
-----------------
* Procedure: gene therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Homozygous familial hypercholesterolemia, i.e.: Low-density lipoprotein (LDL) cholesterol greater than 500 mg/dL Autosomal dominant inheritance Early-onset tendon and tuberous xanthomas LDL receptor negative, i.e.: Receptor binding in cultured fibroblasts no more than 20% of normal OR Genotype with 2 previously described, disease-causing alleles Advanced coronary heart disease with relatively poor prognosis, i.e: Angina pectoris History of myocardial infarction Positive exercise tolerance test Atherosclerotic disease in proximal aorta or coronary arteries by ultrasound or angiogram None of the following: Unstable angina pectoris Left ventricular ejection fraction less than 30% Decompensated congestive heart failure Untreated ventricular tachycardia Moderate to severe aortic stenosis Other dyslipidemia Obstructive hepatobiliary disease Prior/Concurrent Therapy At least 2 weeks since the following: Drugs affecting cholesterol metabolism Plasma exchange LDL apheresis --Patient Characteristics-- Age: Any age Renal: No azotemia No significant proteinuria Other: No hypothyroidism No diabetes

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

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: gene therapy|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
-----------------
rare disease, familial hypercholesterolemia, inborn errors of metabolism
Very-low-density-lipoprotein Triglyceride (VLDL-TG) Uptake in Visceral Fat

Study Overview
=================
Brief Summary
-----------------
Purpose: To investigate the uptake of VLDL-TG in visceral fat in lean and overweight individuals

Official Title
-----------------
Very-low-density-lipoprotein Triglyceride(VLDL-TG) Uptake in Visceral Fat

Conditions
-----------------
Healthy, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Age: 20-50 years Premenopausal Exclusion Criteria: Smoking Alcohol abuse Use of medications

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Lean premenopausal women | |
| 2<br>Visceral obese premenopausal women | |

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
-----------------
Obesity, Lipid metabolism, VLDL
Benfotiamine Prevents Vascular Dysfunction in Healthy Smokers

Study Overview
=================
Brief Summary
-----------------
Benfotiamine pretreatment (3 days)at high dosage (1050 mg/day) prevents in healthy subjects smoking-induced vascular dysfunction assessed by ultrasound flow mediated dilatation of the brachial artery.

Detailed Description
-----------------
Benfotiamine pretreatment (3 days)at high dosage (1050 mg/day) prevents in healthy subjects smoking-induced vascular dysfunction assessed by ultrasound flow mediated dilatation (FMD) of the brachial arteryand laboratory parameters (adhesion molecules).

Official Title
-----------------
Benfotiamine Prevents Vascular Dysfunction in Healthy Smokers

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: Benfotiamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy habitual smokers Exclusion Criteria: any kind of chronic disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Benfotiamine and Smoking<br> | Drug: Benfotiamine<br> <br> |
| Placebo Comparator: Smoking alone<br> | Drug: Benfotiamine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow mediated dilatation |  | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory markers of endothelial function |  | 3 days |
Efficacy and Safety Study of Esomeprazole vs Omeprazole to Treat Acute Non-Variceal Upper Gastrointestinal Bleeding

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy and safety of Esomeprazole and Omeprazole intravenous every 12 hours for 5 days in subjects with acute non-variceal upper gastrointestinal bleeding

Official Title
-----------------
A Randomised, Double-Blind, Double-Dummy, Active-Controlled, Multicenter Study to Assess the Efficacy and Safety of Esomeprazole or Omeprazole for 5 Days in Subjects With Acute Non-Variceal Upper Gastrointestinal Bleeding

Conditions
-----------------
Gastrointestinal Hemorrhage

Intervention / Treatment
-----------------
* Drug: Esomeprazole IV
* Drug: Omeprazole IV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 18-65 years. GI bleeding or with such signs within 48 hours as judged by the investigator as to have non-variceal upper GI bleeding. One endoscopically confirmed bleeding peptic ulcer or erosive gastritis Exclusion Criteria: GI bleeding caused by Esophageal varices Mallory Weiss syndrome Zollinger-Ellison syndrome Suspicion of gastric malignancy at baseline endoscopy Post-Billroth-resection Unknown source of GI bleeding · 2.Unstable vital signs

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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Esomeprazole IV|nan|
|Drug: Omeprazole IV|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the efficacy by assessment of proportion of subjects who present with no clinically significant bleeding after 5 days treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who present with no clinically significant upper GI bleeding after 72-hour treatment |  |  | 
| Time to absence of clinically significant upper GI bleeding |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute non-variceal upper gastrointestinal bleeding
A Study of Rizatriptan Co-Administered With Acetaminophen for the Treatment of Acute Migraine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test an experimental drug combination of two medications currently approved by the Food and Drug Administration (FDA) for migraine headache or other pain. These are called rizatriptan given with acetaminophen.

Official Title
-----------------
A Double-Blind, Double-Dummy, Randomized, Parallel-Group, Placebo Controlled Study to Evaluate the Efficacy and Tolerability of Rizatriptan 10mg Co-Administered With Acetaminophen for the Treatment of Acute Migraine.

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Drug: Rizatriptan co-administered with Acetaminophen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is at least 18 years of age Subject has at least a 6 month history of migraine, with or without aura Subject can distinguish between migraine attacks and other types of headaches Subject of childbearing potential agrees to use adequate contraception Exclusion Criteria: Subject typically has fewer than 1 or greater than 6 migraine attacks per month Subject typically has greater than 10 headache days per month Subject has evidence of ischemic heart disease Subject has uncontrolled high blood pressure Subject has a history, within 1 year, or current evidence of drug or alcohol abuse *This list is not all inclusive*

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: Rizatriptan co-administered with Acetaminophen|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the efficacy of rizatriptan co-administered with acetaminophen to placebo, acetaminophen and rizatriptan for the acute treatment of migraine, as measured by the percentage of patients with pain relief at 2 hours. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hour sustained pain relief |  |  | 
| Pain relief at 30, 45,60,90 minutes and 4 hours post dose |  |  | 
| Pain freedom at 30,45,60,90 minutes and 2 and 4 hours post dose |  |  | 
| 24 sustained pain freedom |  |  | 
| Associated symptoms of phonophobia, photophobia, nausea and vomiting |  |  | 
| Functional disability |  |  | 
| Use of rescue medication |  |  | 
| Self-reported adverse experiences |  |  |
Doxycycline in Treatment of Bleeding With Depot Medroxyprogesterone Acetate (DMPA)

Study Overview
=================
Brief Summary
-----------------
This study aims to test the effect of Doxycycline in treatment of uterine bleeding during the use of injectable contraception that contains one hormone progesterone only.

Official Title
-----------------
Doxycycline in Treatment of Bleeding With DMPA: a Double Blinded Randomized Controlled Trial

Conditions
-----------------
Uterine Hemorrhage

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women under DMPA contraception for at least one month. Accept to participate in the trial after receiving adequate information about the trial including information that she is a part of randomization comprising the possibility of receiving new treatment for bleeding or inactive ingredients. Women's ability to keep an accurate menstrual diary for the study. Exclusion Criteria: Lactating women for the fear of the effect of tetracycline on the breast-fed infant. Patients with already diagnosed local gynecological abnormality. Women receiving treatment for bleeding within the last one month.

Ages Eligible for Study
-----------------
Minimum Age: 20 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Women in this arm will receive identical Placebo capsules twice daily for 5 days | Drug: Placebo<br>* Placebo capsules twice daily for 5 days<br>|
| Active Comparator: Doxycycline<br>Women in this arm will receive 100 mg doxycycline capsules twice daily for 5 days | Drug: Doxycycline<br>* 100 mg Doxycycline capsules twice daily for 5 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stoppage of bleeding within 7 days |  | 7 days from starting of tretment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days needed to stop a current attack of bleeding |  | 1 month | 
| Next bleeding free interval |  | 3 month | 
| Uterine bleeding patterns in the next 3 months after treatment |  | 3 months | 
| Women satisfaction with the treatment she received |  | 3 months | 
| Side effects encountered during treatment |  | 5 days | 
| Discontinuation of the DMPA and its reason |  | 3 months |
Emergency Contraception - User's Profile

Study Overview
=================
Brief Summary
-----------------
Retrospective analysis of requests of emergency hormonal contraception using pharmacy protocols registered in 2003 and 2006.

Detailed Description
-----------------
In 2002, Levonorgestrel was introduced in Switzerland for emergency hormonal contraception (EC) without prescription ('pharmacist only'). In 2003, a first analysis of requests of EC showed that the dispensing of EC through pharmacies could successfully be implemented (Lemke et al 2004). This study was repeated three years later with the aim to explore whether the user's profile has changed after introduction of a low threshold access to EC.

Official Title
-----------------
Emergency Contraception - Observational Study of User's Profile

Conditions
-----------------
Postcoital Contraception

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women seaking emergency hormonal contraception Exclusion Criteria: -
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 |
| --- | --- | --- |
| Sexual and protective behaviour | questions of interest: Did you forget to take the pill?, Did you have any other unprotected sexual intercourse since your last period? and Have you ever taken the morning-after pill before? | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| elapsed hours since unprotected intercourse |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Emergency contraception, Emergency hormonal contraception, Community pharmacies, Pharmaceutical care, Time to access, Written assessments, Switzerland