linjc16/ctgov huggingface dataset:
Oxycodone/Naloxone Prolonged Release (OXN PR) Compared to Placebo to Demonstrate Improvement in Symptoms of Restless Legs Syndrome (RLS) in Subjects With Moderate to Severe Idiopathic RLS With Daytime Symptoms

Study Overview
=================
Brief Summary
-----------------
The primary objective for the 12-week Titration-/Maintenance Period is: To demonstrate superior efficacy of OXN PR compared to PLA in the improvement of symptom severity of RLS.

Detailed Description
-----------------
A randomised, double-blind, placebo-controlled, parallel-group, multicenter study to demonstrate improvement of symptoms of RLS in subjects with moderate to severe idiopathic RLS with daytime symptoms who take oxycodone/naloxone prolonged release (OXN PR) compared to subjects taking placebo (PLA).

Official Title
-----------------
A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Demonstrate Improvement of Symptoms of RLS in Subjects With Moderate to Severe Idiopathic RLS With Daytime Symptoms Who Take OXN PR Compared to Subjects Taking Placebo (PLA).

Conditions
-----------------
Moderate to Severe Idiopathic RLS With Daytime Symptoms

Intervention / Treatment
-----------------
* Drug: Oxycodone naloxone prolonged release tablets (OXN PR)
* Other: Placebo (PLA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe idiopathic RLS with daytime symptoms Exclusion Criteria: Females who are pregnant or lactating. Subjects with evidence of significant structural abnormalities of the gastrointestinal tract. Subjects with evidence of impaired liver/kidney function upon entry into 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OXN PR<br>Different daily doses; intake every 12 hours | Drug: Oxycodone naloxone prolonged release tablets (OXN PR)<br>* Different daily doses; intake every 12 hours<br>|
| Placebo Comparator: PLA<br>Different daily doses; intake every 12 hours | Drug: Oxycodone naloxone prolonged release tablets (OXN PR)<br>* Different daily doses; intake every 12 hours<br>Other: Placebo (PLA)<br>* Different daily doses; intake every 12 hours<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the IRLS score between the two treatment arms will be compared | The primary objective for the 12-week Titration-/Maintenance Period is: IRLS: International Restless Legs Syndrome Study Group Rating Scale Assessment Period baseline (visit 3) to final Maintenance Period. | 12 weeks and a 6 month extension |
GERD After Sleeve Gastrectomy

Study Overview
=================
Brief Summary
-----------------
The main adverse effect is gastroesophageal reflux disease (GERD), with concern on the development of Barrett's esophagus and esophageal adenocarcinoma in the long term. However, the relationship between SG and GERD is complex. The aim of this study is to systematically evaluate all published data existing in the literature to evaluate the effect of sleeve gastrectomy on GERD, esophagitis, BE in order to clarify the long-term clinical sequelae of this procedure. This systematic review was conducted in accordance with the guidelines for Preferred Reporting Items for Systematic Review and Meta-analyzes (PRISMA). Published studies that contained outcome data for primary sleeve gastrectomy associated with the primary and secondary outcomes listed below were included.

Official Title
-----------------
The New Onset of GERD After Sleeve Gastrectomy: a Systematic Review

Conditions
-----------------
Morbid Obesity, GERD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients underwent to sleeve gastrectomy with reflux symptoms Exclusion Criteria: Patients underwent to other bariatric procedures

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- | --- |
| Gastroesophageal reflux disease after bariatric surgery | Number of patients underwent sleeve gastrectomy with GERD | from 2014 to 2018 |
A Study of LY3471851 in Participants With Eczema

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to learn more about the safety and side effects of LY3471851 when given by injection just under the skin to participants with eczema. The study will last up to 48 weeks and may include up to 23 visits to the study center.

Official Title
-----------------
A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous LY3471851 in Patients With Atopic Dermatitis

Conditions
-----------------
Dermatitis, Atopic

Intervention / Treatment
-----------------
* Drug: LY3471851
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a confirmed diagnosis of atopic dermatitis (AD) for least 12 months Have active AD according to study specific criteria Be willing and able to undergo skin biopsies Exclusion Criteria: Have received certain topical medications for AD within 14 days prior to baseline Have received certain systemic medications for AD within 4 weeks prior to baseline Have received LY3471851 previously

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LY3471851<br>LY3471851 administered subcutaneously (SC) | Drug: LY3471851<br>* Administered SC<br>* Other names: NKTR-358;|
| Placebo Comparator: Placebo<br>Placebo administered SC | Drug: Placebo<br>* Administered SC<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Baseline through Study Completion (up to Week 48) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3471851 | PK: AUC of LY3471851 | Postdose on Day 1 through Day 14 | 
| PK: Trough Concentrations (Ctrough) of LY3471851 | PK: Ctrough of LY3471851 | Week 12 | 
| PK: Maximum Concentration (Cmax) of LY3471851 | PK: Cmax of LY3471851 | Postdose on Day 1 through Day 14 |
A Drug-Drug Interaction Study of ALKS 5461 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the impact of Itraconazole on the pharmacokinetics of ALKS 5461.

Official Title
-----------------
A Phase 1 Study of the Effects of Itraconazole on the Pharmacokinetics of ALKS 5461 in Healthy Volunteers

Conditions
-----------------
Pharmacokinetics

Intervention / Treatment
-----------------
* Drug: Itraconazole
* Drug: ALKS 5461


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has a body mass index (BMI) of 18.0 - 30.0 kg/m2 Is in good physical health Agrees to use an approved method of contraception for the duration of the study Additional criteria may apply Exclusion Criteria: Has current evidence, or history of any clinically significant medical or psychiatric condition or observed abnormality Is currently pregnant or breastfeeding Has a history of or current infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV) Has a lifetime history of opioid abuse or dependence Has current abuse or dependence on alcohol or any drugs Has used nicotine within 90 days prior to randomization Additional criteria may apply

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Itraconazole<br>Itraconazole or placebo | Drug: Itraconazole<br>* Administered orally in a crossover design<br>* Other names: Itraconazole or placebo;|
| Experimental: ALKS 5461<br>ALKS 5461 or placebo Sublingual tablet | Drug: ALKS 5461<br>* Administered sublingually in a crossover design<br>* Other names: ALKS 5461 or placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug-Drug Interaction - AUC0-t | Area under the concentration time curve from time zero to the last measureable time point (AUC0-t) of ALKS 5461 in the presence and absence of itraconazole | Up to 48 hours | 
| Drug-Drug Interaction - AUC0-inf | Area under the concentration time curve from time zero to infinity (AUC0-inf) of ALKS 5461 in the presence and absence of itraconazole | Up to 48 hours | 
| Drug-Drug Interaction - Cmax | Maximum plasma concentration (Cmax) of ALKS 5461 in the presence and absence of itraconazole | Up to 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability will be measured by incidence of adverse events |  | Up to 32 Days |
Regulation of Lipoprotein Transport in Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether PPAR-delta agonist (GW5015156)had favorable effect on lipoprotein metabolism.

Detailed Description
-----------------
The metabolic syndrome (MetS) portends diabetes and cardiovascular disease (CVD). Dyslipoproteinaemia, reflected by elevated plasma triglyceride and reduced high-density lipoprotein (HDL) concentrations, is a cardinal feature of MetS that independently predicts CVD and is accordingly a therapeutic target for risk reduction. GW5015156 is a new PPAR-delta agonist that could be used to treat dyslipidemia in insulin resistance and obesity. However, the precise mechanisms of action of this agent on lipoprotein kinetics in MetS subjects have not yet fully been investigated. We therefore carried out a study to study the effect of GW5015156 on lipoprotein transport in subject with metabolic syndrome.

Official Title
-----------------
Effect of PPAR-Delta Agonist on Lipoprotein Kinetics in Metabolic Syndrome

Conditions
-----------------
Obesity, Lipid Disorders, Cardiovascular Disease

Intervention / Treatment
-----------------
* Drug: GW501516
* Drug: placebo pill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any three of the following: Waist circumference > 102 cm Triglycerides > 150 mg/dL HDL-cholesterol < 40 mg/dL Blood glucose > 110 mhg/dL Blood pressures > 130/85 mmHg Exclusion Criteria: Triglycerides > 500 mg/dL Diabetes mellitus CVD Consumption of > 30 g alcohol/day Use of agents affecting lipid metabolism APOE2/E2 genotype Creatinemia (> 120 umol/L) Hypothyroidism Abnormal liver and muscle enzymes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>placebo group | Drug: placebo pill<br> <br> |
| Active Comparator: 2<br>GW501516, 2.5mg | Drug: GW501516<br>* 2.5mg/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ApoB transport rate |  | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ApoA and C-III transport rate |  | 5 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug treatment
A Multiple Dose Study to Evaluate Subcutaneous AMG 108 in Subjects With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if AMG 108 in combination with methotrexate is safe and effective in the treatment of rheumatoid arthritis.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects With Rheumatoid Arthritis.

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: AMG 108
* Drug: AMG 108
* Drug: AMG 108
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with active rheumatoid arthritis as diagnosed by meeting ACR classification criteria for at least 6 months. Must be taking MTX consecutively for >/= 12 weeks and at a stable dose of methotrexate at 15-25 mg weekly for at least 4 weeks prior to screening Exclusion Criteria: Receipt of commercial or experimental biologic therapies for the treatment of inflammatory disease Presence of serious infection Class IV rheumatoid arthritis Prior or current history of tuberculosis infection or exposure Any other DMARDs other than methotrexate within 6 weeks of screening Pregnant or nursing Receipt of live vaccines within 3 months Felty's syndrome

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>196 subjects | Drug: AMG 108<br>* 50mg via SC (subcutaneous) injection every 4 weeks<br>|
| Experimental: 3<br>196 subjects | Drug: AMG 108<br>* 250mg via SC (subcutaneous) injection every 4 weeks<br>|
| Experimental: 2<br>196 subjects | Drug: AMG 108<br>* 125mg via SC (subcutaneous) injection every 4 weeks<br>|
| Placebo Comparator: 4<br>196 subjects | Drug: Placebo<br>* Placebo via SC (subcutaneous) injection every 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR20 response |  | 24 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in subject reported outcomes |  | 24 Weeks | 
| ACRn, AUC ACRn, ACR50, ACR70, and DAS28 |  | 24 Weeks | 
| PK parameters |  | 24 Weeks | 
| Safety endpoints including AEs, SAEs, SIEs, and change in anti-AMG 108 antibody status |  | 24 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ACR criteria, methotrexate, DMARDs, patient reported outcomes, joint assessment
Hormonal Stimulation in IUI Treatment: Is Clomifen Combined With Ethinyl Estradiol Better, Worse or Equal to Menopur

Study Overview
=================
Brief Summary
-----------------
What is the best medication for hormonal stimulation in cycles with high intra-uterine insemination: tablets of Clomifen (5 days) followed by tablets of Ethinyl Estradiol (5 days) or daily injections with Human Menopausal Gonadotropin (Menopur)?

Conditions
-----------------
Subfertility

Intervention / Treatment
-----------------
* Drug: Clomifen, Ethinyl Estradiol
* Drug: Menotropins


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women younger than 42 years old infertility of at least one year normal tubal, pelvic and uterine anatomy semen with total motility count of at least 5 million (at least one sample) Exclusion Criteria: premature ovarian failure medical history of tubal or ovarian surgery tubal or pelvic adhesions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

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

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

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: Tablets<br>Clomifen (5 days) followed by Ethinyl Estradiol (5 days) | Drug: Clomifen, Ethinyl Estradiol<br>* starting on day 2 or 3 of the cycle: 1 tablet of Clomifen each day, for 5 days in a row. Dose 50mg or in subsequent cycles, 25 mg or 100 mg or 150 mg. After the 5 days of Clomifen, one tablet of Ethinyl Estradiol 50 mg per day, for 5 days in a row or until beta hCG is injected<br>|
| Active Comparator: human menopausal gonadotropins<br>Daily Injections | Drug: Menotropins<br>* Starting on day 2 or 3 of the cycle, a daily subcutaneous injection of 37.5 IU or 75.0 IU<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rate |  | on average 30 days if not pregnant and 12 weeks if pregnant |
Dexamphetamine Sustained Release Pharmacokinetics and Clinical Validation of Dried Blood Spots

Study Overview
=================
Brief Summary
-----------------
The pharmacokinetics of 10 to 12 individuals receiving 60 mg of sustained release dexamphetamine will be studied. These individuals have received this medication before in a previous trial where the pharmacodynamics were investigated. This trial will last 5 consecutive days during which blood samples will be drawn for pharmacokinetics analyses. Dried blood spots will also be collected for the clinical validation of the bioanalytical method wherein these are used.

Official Title
-----------------
Pharmacokinetics of New Dexamphetamine Sustained Release Tablets and the Clinical Validation of Measuring Dexamphetamine in Dried Blood Spots

Conditions
-----------------
Cocaine Addiction

Intervention / Treatment
-----------------
* Drug: Dexamphetamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have completed at least 80% of the previous study (CATCH) Be able and willing to participate in the study and assessments Have provided written informed consent. Exclusion Criteria: Any intake of dexamphetamine 7 days or less before the start of the proposed study; Contraindications for dexamphetamine (desired) pregnancy or continued lactation Insufficient command of the Dutch language Current participation in another trial

Ages Eligible for Study
-----------------
Minimum Age: 25 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: Study group<br>Participants receiving Dexamphetamine 60 mg SR | Drug: Dexamphetamine<br>* Participants will receive 60 mg Dexamphetamine SR daily for 5 consecutive days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the Curve (AUC) of dexamphetamine |  | Determined on the 5 day bloodsamples taken | 
| Maximum plasma concentration (Cmax) of dexamphetamine |  | Determined on the 5 day bloodsamples taken | 
| Half life (T 1/2) of dexamphetamine |  | Determined on the 5 day bloodsamples taken |