linjc16/ctgov huggingface dataset:
Intravitreal Bevacizumab (Avastin) for Pseudophakic Macular Edema (PME)

Study Overview
=================
Brief Summary
-----------------
To report safety and efficacy of intravitreal injection of bevacizumab in patients with cystoid macular edema secondary to cataract surgery.

Official Title
-----------------
Intravitreal Bevacizumab (Avastin) for Pseudophakic Macular Edema (PME)

Conditions
-----------------
Cystoid Macular Edema

Intervention / Treatment
-----------------
* Drug: Bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pseudophakic eyes with macular edema Exclusion Criteria: Other retinopathies
Sexes Eligible for Study
-----------------
All

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Study of NeoRecormon (Epoetin Beta) in Patients With End Stage Renal Disease.

Study Overview
=================
Brief Summary
-----------------
This single arm study will determine the effects of complete anemia correction in anemic patients with end-stage renal disease currently receiving suboptimal doses of NeoRecormon. Patients on dialysis receiving NeoRecormon, and with a hemoglobin level <105g/L, will be treated with subcutaneous NeoRecormon at a dose determined by the investigator in order to reach (within 3 months) and maintain a hemoglobin level in the range of 120-135g/L. Heart function and quality of life will be measured before and after anemia correction. 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 Improvement in Heart Function After Complete Anemia Correction With NeoRecormon in Patients With End-Stage Renal Disease Already Receiving Sub-Optimal Doses of NeoRecormon

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; on renal dialysis >= 3 months; receiving NeoRecormon treatment >= 3 months; Hb stable and <105g/L, and LVMI >160g/m2. Exclusion Criteria: unstable hypertension, myocardial infarction, unstable angina pectoris or risk of deep vein thrombosis in last 6 months; use of any ESA other than NeoRecormon; acute infection; use of iv NeoRecormon.

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: Single Group 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/L<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hb level, BP. |  | Throughout study | 
| LVMI ejection fraction, ejection fraction. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SAEs, AEs leading to withdrawal, AEs related to NeoRecormon. |  | Throughout study |
DECIDE-HF: Heart Rate Variability in Heart Failure Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether heart rate variability-like parameters are related to changes in the disease status of a subject that suffers from a disease that decreases the pumping function of the heart.

Official Title
-----------------
DECIDE-HF - Heart Rate Variability in Heart Failure Patients

Conditions
-----------------
Systolic Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has signed and dated the study-specific informed consent form Subject is 18 years of age or older Subject is expected to remain available for follow-ups Subject is able and willing to comply with the protocol requirements Subject has predominant Normal Sinus Rhythm Subject has systolic Heart Failure and is at the moment of enrollment in NYHA class II or III and has an ejection fraction of less then 40% Subject has had a HF-related hospitalization in the past 12 months Exclusion Criteria: Subject needs permanent atrial pacing (> 10%) Subject has intermittent 2nd or intermittent 3rd degree block Subject has persistent or permanent AF Subject has Long QT syndrome, Brugada syndrome, Jervell and Lange- Nielsen syndrome, Romano-Ward syndrome, Andersen-Tawil syndrome or Timothy's syndrome Subject has had recent (<2 months) acute coronary syndrome Subject has had recent (<2 months) revascularization Subject has a pending cardiac transplant or revascularization Subject has severe stenotic valvular heart disease Subject has severe pulmonary (forced expiratory volume in 1 s < 1 L) hepatic or renal (plasma creatinine > 0.2 mmol/L) disease Subject is participating in another study that may affect the results of this 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Heart Failure<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HF diagnostic |  | 2 years |
Open Label Phase III Duloxetine Study for Stress Urinary Incontinence

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to monitor the long term safety of duloxetine in the treatment of stress urinary incontinence.

Official Title
-----------------
Long Term Monitoring of Safety in Subjects Treated With Duloxetine for Stress Urinary Incontinence

Conditions
-----------------
Urinary Incontinence Stress

Intervention / Treatment
-----------------
* Drug: Duloxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female out patients Are ambulatory and are able to use a toilet independently and without difficulty. Exclusion Criteria: Use of monoamine oxidase inhibitors (MAOIs)

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

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

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: Duloxetine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study is to generate long-term safety data for duloxetine in the treatment of women with stress urinary incontinence. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary objective of this study is to collect data to demonstrate the maintenance of effect of duloxetine on patients quality of life, measured by Patient Impression of Improvement questionnaire. |  |  |
A PK and Safety Study in Subjects With Hepatic Impairment

Study Overview
=================
Brief Summary
-----------------
Assess the single dose PK and safety of TR701 FA in subjects with Moderate or Severe hepatic impairment versus matched control subjects with normal hepatic function.

Detailed Description
-----------------
This study will assess the single-dose pharmacokinetics (PK) and safety of TR-701 free acid (FA) in subjects with Moderate or Severe hepatic impairment compared with matched control subjects with normal hepatic function.

Official Title
-----------------
A Phase 1 Open-Label Study With Oral TR-701 FA to Assess Pharmacokinetics and Safety in Subjects With Moderate or Severe Hepatic Impairment

Conditions
-----------------
Hepatic Impairment

Intervention / Treatment
-----------------
* Drug: TR-701 FA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate or severe hepatic impairment or matched control BMI between 18.0 and 40.0 kg/m2 Exclusion Criteria: Evidence of acute deterioration of hepatic function within 8 weeks ALT or AST ≥ 5 times upper limit of normal for moderates; ALT or AST ≥ 8 times upper limit of normal for severes Total bilirubin > 5 mg/dl for moderates; no upper limit for severes Hemoglobin < 10g/dl for moderates; Hemoglobin < 9g/dl for severes

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

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moderate hepatic<br> | Drug: TR-701 FA<br>* Oral single dose 200 mg<br>|
| Experimental: Severe Hepatic<br> | Drug: TR-701 FA<br>* Oral single dose 200 mg<br>|
| Experimental: Matched control<br> | Drug: TR-701 FA<br>* Oral single dose 200 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK Assessment | PK Assessment in moderate and severe hepatic impairment and matched controls.PK Assessments include plasma parameters maximum observed concentration (Cmax), time to occurrence of Cmax, area under the plasma concentration-time curve from Hour 0 to the last measurable concentration(AUC0-t), area under the plasma concentration-time curve from Hour 0 extrapolated to infinity (AUC0-∞)and systemic clearance. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Safety Assessments evaluated through adverse events, laboratory evaluations (hematology and chemistry), vital signs, ECGs, and physical examinations, in moderate and severe hepatic impairment and matched controls. | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatic Impairment, Matched control subjects
Novel Regimens in COVID-19 Treatment

Study Overview
=================
Brief Summary
-----------------
Nitazoxanide has been shown to have a clinical efficacy against severe acute respiratory syndrome coronavirus 2; ivermectin has also demonstrated a remarkable experimental efficacy with a potential to be used for Coronavirus disease 2019.

Detailed Description
-----------------
Nitazoxanide has been shown to have a clinical efficacy against severe acute respiratory syndrome coronavirus; ivermectin has also demonstrated a remarkable experimental efficacy with a potential to be used for Coronavirus disease 2019. Some studies demonstrated the efficacy of combined regimen of nitazoxanide and azithromycin or ivermectin and chloroquine.

Official Title
-----------------
Nitazoxanide in Treatment of COVID-19

Conditions
-----------------
COVID, Corona Virus Infection

Intervention / Treatment
-----------------
* Drug: Nitazoxanide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with COVID-19 infection Exclusion Criteria: Allergy or contraindication to the drugs.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nitazoxanide<br>Nitazoxanide with standard protocol of treatment | Drug: Nitazoxanide<br>* Nitazoxanide<br>* Other names: Parazoxanide, Nanazoxid;|
| No Intervention: Control group<br>Standard protocol alone | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with virological cure | the number of patients with virological cure | 6 months |
Apelin in Willis Ekbom Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess apelin level in patients with Willis-Ekbom Disease (WED) as known Restless Legs Syndrome (RLS). Cardiovascular complications of WED have been reported in recent studies. Increased oxidative stress is thought to play an important role in cardiovascular complications of WED patients. Apelin is a novel described antioxidant bioactive peptide. The investigators hypothesize that patients with WED have lower plasma apelin level than healthy subjects based on presence of oxidative stress of WED.

Official Title
-----------------
Oxidative Stress and Apelin Level in Willis Ekbom Disease

Conditions
-----------------
Restless Legs Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed as RLS/WED according to International Classification of Sleep Disorders (ICSD-3) criteria Patients with idiopathic RLS/WED Moderate and severe RLS/WED according to International Restless Legs Syndrome Rating Scale Periodic Leg Movements Index above 5 in polysomnography record BMI below 25 Exclusion Criteria: Disorders which cause symptomatic RLS(Iron deficiency anemia, kidney failure, diabetes mellitus, pregnancy, Parkinson's disease, multiple sclerosis, neuropathy) Systemic diseases which cause possible oxidative stress status (cardiovascular diseases, obesity, diabetes mellitus, use of any medical drugs especially ACE inhibitors e.g.) Another sleep disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- | --- |
| Serum apelin level in WED patients and healthy controls |  | Two months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Restless Legs Syndrome, Apelin, Oxidative Stress
A Safety and Efficacy Study of T0903131 (INT131) Besylate to Treat Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine if repeated daily doses of T0903131 (INT131) Besylate over 4 weeks can lower fasting blood glucose in patients with Type 2 Diabetes Mellitus.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, 4-week Study to Evaluate the Safety and Efficacy of T0903131 Besylate in Subjects With Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus, Type II

Intervention / Treatment
-----------------
* Drug: T0903131 Besylate
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical Diagnosis of Type 2 Diabetes Mellitus for at least 3 months prior to enrollment Fasting Plasma Glucose between 126 and 240 mg/dL Hemoglobin-A1c (HbA1c) between 6.8% and 10.0% Fasting C-peptide > 0.8 ng/mL Exclusion Criteria: Treatment with any pharmacotherapy for Type 2 Diabetes Mellitus within previous 6 weeks prior to screening Prior treatment with Thiazolidinedione, including Troglitazone, Rosiglitazone, pioglitazone BMI > 42 kg/m2 Presence of any diabetic complications requiring chronic therapy Presence or history of any form of hepatic disease Serum creatinine > 1.8 mg/dL History of cardiac arrhythmias or abnormal cardiac electrophysiology Any reason that, in the Investigator's judgment, would have interfered with the ability of the subject to comply with the requirements of the protocol

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T0903131 Besylate<br>1.0 mg | Drug: T0903131 Besylate<br>* Once daily, oral<br>* Other names: INT131 Besylate;|
| Experimental: T0903131 Besylate (higher dose)<br>10.0 mg | Drug: T0903131 Besylate<br>* Once daily, oral<br>* Other names: INT131 Besylate;|
| Placebo Comparator: Placebo<br>Once daily, oral | Drug: Placebo<br>* Once daily, oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effect of Ultrasound Guided Embryo Transfer on Pregnancy Rates

Study Overview
=================
Brief Summary
-----------------
To assess the effect of transabdominal ultrasound guided embryo transfer on the pregnancy rates versus clinical touch technique

Detailed Description
-----------------
A total of 90 patients undergoing treatment with ICSI were divided into 2 groups: group 1 (45 patients), had ultrasound guided embryo transfer and group 2 (45 patients), underwent embryo transfer using the clinical touch technique

Official Title
-----------------
Effect of Ultrasound Guided Embryo Transfer on Pregnancy Rates

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: GnRh, HMG, HCG, Progesterone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age (20-39) Male factor infertility Ovarian factor infertility Unexplained infertility Exclusion Criteria: Tubal factor infertility Endometriosis FSH > 16 iu/l on cycle day 3 Less than 2 embryos grade A Difficult embryo transfer

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 39 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound guided embryo transfer<br>GnRh, HMG, HCG, Progesterone 45 patients had ultrasound guided embryo transfer during ICSI | Drug: GnRh, HMG, HCG, Progesterone<br>* GnRh analogue (0.05 mg/day), HMG (150-300 iu/day), HCG (5000 iu/day), Progesterone (100 mg/day)<br>|
| Placebo Comparator: clinical touch technique<br>GnRh, HMG, HCG, Progesterone 45 patients had embryo transfer using clinical touch technique during ICSI | Drug: GnRh, HMG, HCG, Progesterone<br>* GnRh analogue (0.05 mg/day), HMG (150-300 iu/day), HCG (5000 iu/day), Progesterone (100 mg/day)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess clinical pregnancy rates after using ultrasound guided embryo transfer |  | After December, 2012 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Embryo transfer, transabdominal ultrasound, IVF, ICSI
Association of Lunar Phases With Post-surgical Morbidity

Study Overview
=================
Brief Summary
-----------------
The potential influence of lunar phases on human life has been widely discussed by the lay press. The purpose of this study was to evaluate a possible relation between the lunar cycle and the hemorrhagic complication rate and surgical outcome. PATIENTS AND METHODS: The investigators tested this hypothesis by evaluating the complication rate for 18760 patients who underwent surgery from January 2001 to December 2008 (103 lunar phases) at the National Institute for Cancer Research in Genoa. The date of definitive surgery was allocated to the lunar phases.

Official Title
-----------------
Association of Lunar Phases With Post-surgical Hemorrhagic Rate

Conditions
-----------------
Hemorrhage

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: None Exclusion Criteria: None

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 |
| --- | --- | --- |
| Dependence analysis between post-surgical complications and lunar phases. |  | 2001 - 2008 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgery, Moon phases, hemorrhage