linjc16/ctgov huggingface dataset:
A Phase I Study to Assess the Electrophysiologic Effects of BMS-394136 on the Atrium and Ventricle in Patients With Dual-Chamber Pacemakers or Defibrillators

Study Overview
=================
Brief Summary
-----------------
Double-Blind, Randomized, Single-Dose Study to Evaluate the Atrial Selectivity and Safety of BMS-394136 in Subjects with Implanted Dual-Chamber Pacemakers or Defibrillators

Official Title
-----------------
Double-Blind, Randomized, Single-Dose Study to Evaluate the Atrial Selectivity and Safety of BMS-394136 in Patients With Implanted Dual-Chamber Pacemakers or Defibrillators

Conditions
-----------------
Heart Diseases

Intervention / Treatment
-----------------
* Drug: BMS-394136
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with dual-chamber pacemakers or defibrillators Exclusion Criteria: Recent acute ischemic events Recent atrial or ventricular arrhythmias Uncompensated heart failure Amiodarone use within last year Women of childbearing potential QTc <430 msec males QTc <450 msec females

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A1<br> | Drug: BMS-394136<br>* Oral Solution, Oral, 100 mg, Single dose, 1 day.<br>|
| Placebo Comparator: A2<br> | Drug: Placebo<br>* Oral Solution, Oral, 0 mg, Single dose, 1 day.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of BMS-394136 on atrial refractoriness (atrial effective refractory period) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of BMS-394136 on atrial vs ventricular refractoriness |  |  | 
| Effect of BMS-394136 on the QTc interval |  |  | 
| Assess the safety and tolerability of a single dose of BMS-394136 |  |  | 
| Explore the relationship between plasma concentration of BMS-394136 and refractoriness |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients requiring dual-chamber pacemakers or defibrillators
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 8 Weeks in Subjects With Chronic Genotype 1 HCV and HIV-1 Co-infection

Study Overview
=================
Brief Summary
-----------------
Target Population: Hepatitis C Treatment Naïve, non-cirrhotic, Chronic genotype 1 hepatitis C virus (HCV) infected adults that are co-infected with human immunodeficiency virus (HIV)-1and have HCV RNA < 6 x106 IU/mL Duration of Subjects will be treated for 8 weeks and followed for 24 weeks post- Treatment: treatment

Official Title
-----------------
A Phase 2, Single-Center, Open-Label Pilot Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 8 Weeks in Subjects With Chronic Genotype 1 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection

Conditions
-----------------
Treatment of Hepatitis C

Intervention / Treatment
-----------------
* Drug: Ledipasvir/Sofosbuvir FDC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic HCV GT1, treatment-naïve, non-cirrhotic adult subjects. HCV RNA levels more than 10,000 IU/mL and less than 6,000,000 IU/mL at Screening Exclusion Criteria: Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug. Solid organ transplantation. Significant cardiac disease or other significant co-morbidities that could interfere with study treatment. Malignancy within the 3 years prior to screening, with the exception of specific cancers that have been cured by surgical resection (basal cell skin cancer, etc.). Subjects under evaluation for possible malignancy are not eligible. Infection with hepatitis B virus (HBV)

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


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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>8 weeks treatment with Ledipasvir/Sofosbuvir FDC | Drug: Ledipasvir/Sofosbuvir FDC<br> <br> * Other names: Harvoni;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SVR12 |  | Sustained Virologic Response 12 Weeks Post-Treatment |
Oestrogen Withdrawal in Hypopituitary Women

Study Overview
=================
Brief Summary
-----------------
By exploring hormonal status in hypopituitary women during oestrogen treatment and without estrogen substitution the influence on sexhormones and organ function is estimated.

Detailed Description
-----------------
38 hypopituitary women were examinined twice. During oestrogen treatment and after 1 month estrogen withdrawal. A control group of healthy women were examined once.Antropometric data and hormonal parameters were collected.

Official Title
-----------------
Oestrogen Withdrawal in Hypopituitary Women

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

Intervention / Treatment
-----------------
* Drug: oestrogen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypopituitarism

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>No oestrogen treatment | Drug: oestrogen<br>* Cyclic oestrogen substitution therapy<br>|
| Experimental: 2<br>Oestrogen treatment | Drug: oestrogen<br>* Cyclic oestrogen substitution therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| androgens, IGF-I, body composition, liver enzymes, |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grehlin, adiponection, leptin |  | 1 month |
A Long Term Study of ALKS 5461 in the Treatment of Refractory Major Depressive Disorder (MDD)

Study Overview
=================
Brief Summary
-----------------
This study will assess the long-term safety and tolerability of ALKS 5461 as an adjunctive treatment for refractory MDD.

Official Title
-----------------
A Phase 3b Extension Study of Adjunctive ALKS 5461 in the Treatment of Refractory Major Depressive Disorder

Conditions
-----------------
Refractory Major Depressive Disorder

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completed study ALK5461-217 Be willing to abide by the contraception requirements as outlined in the study protocol Be willing and able to follow the study procedures and visits as outlined in the protocol Additional criteria may apply Exclusion Criteria: Pregnant, planning to become pregnant, or breastfeeding A positive urine drug test for drugs of abuse Poses a current suicide risk Additional criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 72 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
Interventional Model Description: Open-label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALKS 5461<br>Sublingual tablets | Drug: ALKS 5461<br>* samidorphan + buprenorphine administered sublingually<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Treatment-emergent Adverse Events (TEAEs) | Number and percentage of subjects experiencing TEAEs | Up to 68 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alkermes, Major depressive disorder, Depression, ALKS 5461
Clinical Study of ATTR-CM

Study Overview
=================
Brief Summary
-----------------
In this study, patients with ATTR-CM or gene carriers were selected to study the diagnosis and treatment, and long-term follow-up was conducted.

Official Title
-----------------
Clinical Study Protocol of Transthyroxine Protein Amyloidosis Cardiomyopathy and Its Gene Carriers

Conditions
-----------------
Transthyroxine Amyloidosis Cardiomyopathy

Intervention / Treatment
-----------------
* Drug: ATTR-CM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients and gene carriers of ATTR-CM confirmed in the Second Affiliated Hospital of Zhejiang University School of Medicine, regardless of gender, age 18-90 years old; Patients who have the ability to understand the test and can cooperate with investigators Exclusion Criteria: Patients who unable to understand or unwilling to fill in informed consent forms or follow visitors

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: ATTR-CM<br>Patients or Gene carrier | Drug: ATTR-CM<br>* Current treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of cardiovascular death, myocardial infarction, and stroke | Primary Outcome | 10 year |
A Study of Administration of RoActemra/Actemra (Tocilizumab) by Auto-injector Vs. Pre-filled Syringe in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This open-label, multi-center study will compare the bioavailability of RoActemra/Actemra (tocilizumab) administration by auto-injector versus pre-filled syringe in healthy volunteers. Healthy volunteers will receive a single dose of RoActemra/Actemra (tocilizumab). The anticipated time of study duration is 28 days.

Official Title
-----------------
An Open-label, Multi-center Study to Compare the Relative Bioavailability of Tocilizumab in Healthy Subjects Following Single Dose Subcutaneous (SC) Administration Via Disposable Auto-Injector (DAI) Device vs Pre-filled Glass Syringe (PFS)

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: tocilizumab [RoActemra/Actemra] Syringe
* Drug: tocilizumab [RoActemra/Actemra] auto-injector


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers, age 18 to 65 years inclusive Intact normal skin without potentially obscuring tattoos, pigmentation, lesion in the area for intended injection A body mass index (BMI) between 18 to 32 kg/m2 inclusive Exclusion Criteria: Volunteers with any known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections A history of clinically significant gastrointestinal, renal, hepatic, cardiovascular, or allergic disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: tocilizumab [RoActemra/Actemra] auto-injector<br>* Single dose administration with auto-injector<br>|
| Experimental: 2<br> | Drug: tocilizumab [RoActemra/Actemra] Syringe<br>* Single dose administration with pre-filled syringe<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve (AUC) of RoActemra/Actemra |  | 21 days | 
| Peak plasma concentration of RoActemra/Actemra |  | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (Incidence of adverse events) |  | 28 days |
Compliance in Non Invasive Mechanical Ventilation

Study Overview
=================
Brief Summary
-----------------
Database study of the adherence to treatment to non-invasive mechanical ventilation

Official Title
-----------------
Compliance in Non Invasive Mechanical Ventilation

Conditions
-----------------
Respiratory Insufficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients in non invasive mechanical ventilation and affiliated by the respiratory centre of the East of Denmark registered in telemedical solution in the period from 01.01.2020 to 04.01.2022 Age above 18 years Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Use of treatment more than 4 hr. per day |  | 30 days |
A Study of NeoRecormon in Patients With Chronic Kidney Disease.

Study Overview
=================
Brief Summary
-----------------
This 2 arm study will compare the level of anemia, and the decline in renal function, between patients receiving NeoRecormon, and those not receiving it. Patients with chronic kidney disease, stage 2-4, and not receiving dialysis, will be randomized 2:1 to a group receiving NeoRecormon (at a dose determined by the investigator to achieve and maintain an Hb level of 120-135 g/L), or to a control group not receiving NeoRecormon. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Official Title
-----------------
An Open-Label Study to Investigate the Effect of NeoRecormon on Hemoglobin Level and Renal Function in Patients With Chronic Kidney Disease, Stage 2-4

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: epoetin beta [NeoRecormon]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients,18-75 years of age; end-stage renal disease, not on dialysis; Hb <110g/L. Exclusion Criteria: unstable hypertension; acute infections; use of i.v. NeoRecormon, or use of any other ESA beside NeoRecormon; myocardial infarction, unstable angina or venous thrombosis within 6 months before start of treatment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: epoetin beta [NeoRecormon]<br>* At a dose to achieve and maintain an Hb level of 120-135g/dL.<br>|
| No Intervention: 2<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hb level, decline in renal function, 24h proteinuria, creatinine clearance. |  | Throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SAEs, AEs leading to withdrawal, AEs related to NeoRecormon. |  | Throughout study |
The Accuracy of Amniotic Fluid Ferning in the Second Trimester in the Diagnosis of Preterm Prelabor Rupture of Membranes

Study Overview
=================
Brief Summary
-----------------
Although much investigation has been done on the use of ferning in the second and third trimesters, particularly with the development of rapid protein clinical assays, there appears to be lower ferning rates in clinical practice with traditional techniques compared to previous published research on the subject. Much of the older study designs are lacking in detail and lack a large enough sample sizes at each gestational age to appropriately interpret the significance of ferning results by gestational age. Additionally, a large premise for the current tests used to diagnose rupture of membranes is based on these older studies. Given this, we propose collecting amniotic fluid vaginally to evaluate for the presence of ferning in the second trimester to determine if there is a difference in ferning based on gestational age as well as the time interval after rupture of membranes in which ferning can observed on microscope examination.

Official Title
-----------------
Assessing the Accuracy of Amniotic Fluid Ferning in the Second Trimester in the Diagnosis of Preterm Prelabor Rupture of Membranes

Conditions
-----------------
Preterm Premature Rupture of Membrane, Amniotic Fluid Leakage

Intervention / Treatment
-----------------
* Diagnostic Test: Ferning on microscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older English speaking singleton or multi fetal gestation between 15 and 24 weeks gestation undergoing elective pregnancy termination Exclusion Criteria: known rupture of membranes or anhydramnios

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Before rupture of membranes<br>Vaginal swab collection prior to iatrogenic rupture of membranes | Diagnostic Test: Ferning on microscopy<br>* Amniotic fluid ferning will be assessed in the cohort before known rupture of membranes and after known rupture of membranes<br>|
| After rupture of membranes<br>Vaginal swab collection after iatrogenic rupture of membranes | Diagnostic Test: Ferning on microscopy<br>* Amniotic fluid ferning will be assessed in the cohort before known rupture of membranes and after known rupture of membranes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ferning | the presence of amniotic fluid ferning | 1 minute | 
| Ferning | the presence of amniotic fluid ferning | 5 minutes | 
| Ferning | the presence of amniotic fluid ferning | 10 minutes | 
| Ferning | the presence of amniotic fluid ferning | 15 minutes | 
| Ferning | the presence of amniotic fluid ferning | 20 minutes |
Internet-based, Naturalistic Evaluation of Tolerability and Individual Patient Target Pressures With Bimatoprost 0.03% in Glaucoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the range of target IOPs set for glaucoma patients starting monotherapy with bimatoprost and to evaluate patient and physician satisfaction with bimatoprost in real-world settings

Conditions
-----------------
Glaucoma, Open-Angle

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with either open-angle glaucoma or ocular hypertension were eligible if they needed bilateral IOP reduction beyond what was achieved with their current medication, or if they were intolerant of other IOP-lowering medications.

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