linjc16/ctgov huggingface dataset:
Double and Single Intrauterine Insemination In Controlled Ovarian Stimulation (COH) Cycles With Multifollicular Development

Study Overview
=================
Brief Summary
-----------------
Our hypothesis is double insemination will improve pregnancy rates in coh cycles with more than one dominant follicles (>16mm).

Detailed Description
-----------------
Metaanalysis for the effects of double IUI demonstrates that effects of this procedure is not different from single IUI. It is known that nearly 25% of coh cycles is evident by monofollicular development.For this reason it is possible that this monofollicular cycles in the studies could decrease the effects of double IUI. Inclusion criteria: Patients with unexplained infertility or mild male factor infertility whom admitted to the COH+IUI programme in our infertility unit. Female age <37 years old. Baseline FSH <12 mIU/L Total antral follicle count>6 During the first three cycles of COH+IUI Minimum 2 follicles >16 mm at the day of HCG. Primary outcome: Ongoing pregnancy rates Secondary outcomes: The effects of different coh regimens (CC,FSH,CC+FSH)on the outcomes.

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

Intervention / Treatment
-----------------
* Procedure: Intrauterine insemination (single)
* Procedure: Double intrauterine insemination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unexplained and mild male factor infertile patients Minimum 2 follicles >16 mm at the day of HCG First 3 cycles Exclusion Criteria: Basal FSH >12 mIU/L Total antral follicle count<6 Severe male factor infertility

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 37 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 |
| --- | --- |
| Sham Comparator: Single IUI<br>Single IUI will be carried on after 36-38 hours of HCG administration | Procedure: Intrauterine insemination (single)<br>* Single IUI after 36-38 hours of HCG<br>* Other names: Group I;|
| Active Comparator: Double IUI<br> | Procedure: Double intrauterine insemination<br>* Double insemination after 18 and 40 hours of HCG administration.<br>* Other names: Grup II;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ongoing pregnancy rates |  | pregnancy >12 weeks of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effects of different coh regimens on outcomes |  | 14 days after IUI procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Double IUI, Intrauterine insemination, Unexplained infertility
Study of AT-752 in Healthy Subjects in a Dengue Human Challenge Model

Study Overview
=================
Brief Summary
-----------------
This study will assess the safety and antiviral activity of AT-752 in healthy subjects in a Dengue Human Challenge Model

Detailed Description
-----------------
A Phase 1, double-blind, randomized, placebo-controlled study to assess the antiviral activity and safety of AT-752 in a Dengue Human Challenge Model

Official Title
-----------------
A Phase 1, Double-blind, Randomized, Placebo-controlled Study to Assess the Antiviral Activity and Safety of AT-752 in a Dengue Human Challenge Model

Conditions
-----------------
Dengue

Intervention / Treatment
-----------------
* Drug: AT-752
* Drug: Placebo Comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must agree to use protocol-specified methods of contraception Negative pregnancy test Willing to comply with the study requirements and to provide written informed consent Exclusion Criteria: Pregnant or breastfeeding Abuse of drugs Other clinically significant medical conditions

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AT-752<br>AT-752 administered orally for 14 days | Drug: AT-752<br>* Parallel Assignment<br>|
| Placebo Comparator: Placebo<br>Matching placebo administered orally for 14 days | Drug: Placebo Comparator<br>* Parallel Assignment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean quantitative RNAemia (peak and duration and area under the plasma concentration versus time curve [AUC]) |  | Day 2 until 28 days post virus inoculation |
Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal (PAPIRUS III)

Study Overview
=================
Brief Summary
-----------------
The PAPIRUS III study will continue to follow patients initially enrolled in PAPIRUS II. Pressure readings from the investigational device will continue to be collected and will be correlated to physiological changes during activities of daily living and protocol defined tests.

Detailed Description
-----------------
This is a small clinical trial to determine the feasibility of a device & to test prototype device, where the primary outcome measure relates to feasibility and not to health outcomes.

Official Title
-----------------
Monitoring Pulmonary Artery Pressure by Implanted Device Responding to Ultrasonic Signal

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has been enrolled in the PAPIRUS II Study and has a RemonCHF pressure sensor implanted Patient is willing and able to provide informed consent, participate in the Safety Follow-up Program and/or in the required tests associated with the clinical investigation (Core Study Program) at an approved clinical investigational center and at the intervals defined by the Clinical Investigational Plan. Exclusion Criteria: Patient enrolled in PAPIRUS II but not implanted with a RemonCHF Pressure Sensor Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study (with the exception of the PAPIRUS II Study). Each instance would be brought to the sponsor to determine eligibility. Age < 18 years Women of childbearing potential who are, or might be, pregnant at the time of 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continue detailed data collection of pressure readings from patients implanted with a RemonCHF device. |  | 24 months |
LIVESTRONG Survivorship Care Plan: Continued Data Collection and Follow Up Survey

Study Overview
=================
Brief Summary
-----------------
Cancer survivors face unique health challenges as a result of their cancer diagnosis and treatment. OncoLink created an Internet based program for survivors to learn about their risks. A follow up survey will allow us to continue to develop the program in ways that will benefit users. This survey will need to be conducted via email, which will require the collection of the users email address and a secure method of linking the users care plan questionnaire answers to their survey answers.

Official Title
-----------------
LIVESTRONG Survivorship Care Plan: Continued Data Collection and Follow Up Survey

Conditions
-----------------
Cancer Patient

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of cancer 18 years of age and older Exclusion Criteria: Persons who have never had cancer. This program is designed for survivors of adult cancers. Survivors of childhood cancers are referred to the Children's Oncology Group Long Term Follow up Guidelines.

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

| Intervention/Treatment |
| --- |
|Other: Survey|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects completing questionnaires |  | 2 years |
Subconjunctival Injection of Allogeneic Mesenchymal Stem Cells in Severe Ocular Chemical Burn

Study Overview
=================
Brief Summary
-----------------
The objective of this pre-clinical study is to demonstrate the robustness of Bone Marrow derived Mesenchymal Stem Cells (BM-MSC) production, to treat patients with severe eye burns. For bone marrow donors who agree to participate, a 10 ml BM sample will be collected apart the 1 liter BM dedicated to transplantation. A maximum of three donors of allogeneic BM-MSCs will be included. A ready-to-use BM-MSC suspension will be produced and stored for 10 years to accumulate data about stability of cryopreserved cells.

Official Title
-----------------
Subconjunctival Injection of Allogeneic Mesenchymal Stem Cells in Severe Ocular Chemical Burn SyMbOL Pre Clinical Study

Conditions
-----------------
Bone Marrow Donor

Intervention / Treatment
-----------------
* Other: bone marrow harvest


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - Patient with a bone marrow donation planned Exclusion criteria: The donor is finally not eligible The harvest cannot be performed The sample cannot be obtained during the BM harvest procedure

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: bone marrow harvest|During bone marrow harvest, an additional 10 mL sample will be collected for the study.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of donors needed to obtain 3 BM harvest. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bone marrow harvest, Bone Marrow derived Mesenchymal Stem Cells (BM-MSC), Pre-clinical
Clinical Study of Epoetin Beta to Chemotherapy-Induced Anemia (CIA) Patients

Study Overview
=================
Brief Summary
-----------------
This is a study to investigate the clinical efficacy and safety of epoetin beta 36,000 IU compared with placebo when administrated subcutaneously (s.c.) once-weekly for 12 weeks to anemic patients with lung cancer or gynecologic cancer undergoing chemotherapy.

Official Title
-----------------
A Phase Ⅲ Randomized Double-Blind Placebo-Controlled Study of Epoetin Beta for the Treatment of Chemotherapy-Induced Anemia (CIA) in Cancer Patients

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

Intervention / Treatment
-----------------
* Drug: epoetin beta
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lung cancer or gynecologic cancer patients Undergoing platinum-based chemotherapy repeated for ≧ 2 cycles after erythropoietin (EPO) or placebo administration 8.0 g/dL ≦ hemoglobin concentration (Hb) ≦ 10.0 g/dL 20 - 79 years old Performance status: 0 - 2 No iron deficiency anemia Exclusion Criteria: Red blood cell transfusion within 4 weeks before treatment Erythropoietin therapy within 8 weeks before treatment

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 79 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: EPOCH<br> | Drug: epoetin beta<br>* Subcutaneous administration of epoetin beta 36,000 IU once-weekly for 12 weeks<br>|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* Subcutaneous administration of placebo once-weekly for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of the subjects who receive red blood cell (RBC) transfusion and/or hemoglobin (Hb) concentration < 8.0 g/dL |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hb |  | 16 weeks | 
| Change in FACT- total Fatigue Subscale score (FSS) |  | 16 weeks | 
| Requirement for RBC transfusion |  | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, patients, with, chemotherapy, induced, anemia
A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphataemic Chronic Kidney Disease Patients Not on Dialysis

Study Overview
=================
Brief Summary
-----------------
Approximately 207 hyperphosphatemic CKD patients not on dialysis will be entered into this study at approximately 50 sites within approximately 9 European countries. The purpose of this study is to determine if sevelamer carbonate tablets dosed three times a day (TID) is a safe and effective treatment for the control of serum phosphorous levels in hyperphosphatemic CKD patients not on dialysis. Total length of participation is approximately 24 weeks.

Official Title
-----------------
A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphataemic Chronic Kidney Disease (CKD) Patients Not on Dialysis

Conditions
-----------------
Chronic Kidney Disease, Hyperphosphatemia

Intervention / Treatment
-----------------
* Drug: Sevelamer carbonate
* Drug: Placebo for sevelamer carbonate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Serum phosphorus measurement ≥4.6 mg/dL (≥1.49 mmol/L) and ≤5.5 mg/dL (≤1.76 mmol/L after discontinuation of current phosphate binder therapy if applicable. Exclusion Criteria: Active dysphagia or swallowing disorder or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders including severe constipation.

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 |
| --- | --- |
| Active Comparator: Sevelamer carbonate<br> | Drug: Sevelamer carbonate<br>* 800mg tablets to be taken orally with meals three times per day<br>* Other names: Renvela(TM);|
| Placebo Comparator: Placebo<br> | Drug: Placebo for sevelamer carbonate<br>* Placebo tablets to be taken orally with meals three times per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the efficacy and safety of sevelamer carbonate and placebo dosed three times per day (TID) on serum phosphorus levels |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the efficacy and safety of sevelamer carbonate and placebo dosed three times per day (TID) on serum total cholesterol and low density lipoprotein (LDL) cholesterol |  | 24 weeks | 
| To compare the efficacy and safety of sevelamer carbonate and placebo dosed three times per day (TID) on serum corrected calcium-phosphorus product (CaxP) |  | 24 weeks |
Should we Repair Ischemic Mitral Regurgitation?

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess whether adding mitral valve repair to coronary artery bypass grafting improves outcome in patients with ischemic mitral regurgitation.

Conditions
-----------------
Coronary Disease, Mitral Valve Insufficiency

Intervention / Treatment
-----------------
* Procedure: Mitral valve repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable coronary artery disease Patient accepted for coronary artery bypass surgery Ischemic mitral regurgitation Exclusion Criteria: Acute coronary syndrome within 30 days Organic valvular heart disease Need for other than CABG and mitral valve repair cardiac surgical procedure
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 |
| --- | --- |
| No Intervention: 1<br>Coronary Artery Bypass Grafting with no Mitral Valve intervention | |
| Active Comparator: 2<br>Coronary Artery Bypass Grafting + Mitral Annuloplasty | Procedure: Mitral valve repair<br>* mitral valve annuloplasty<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Trial to Evaluate the Efficacy and Safety of Formoterol Fumarate 20 Mcg/0.5 mL in the Treatment of Patients With COPD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of the investigational drug in comparison with a placebo.

Official Title
-----------------
A 12-week Double-Blind, Parallel-Group, Placebo- and Active- Controlled Trial to Evaluate the Efficacy and Safety of Formoterol Fumarate Inhalation Solution 20 Mcg/0.5 mL Delivered by OMRON MicroAir NE-U22V Nebulizer in the Treatment of Patients With Chronic Obstructive Pulmonary Disease

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Drug: Formoterol Fumarate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medical diagnosis of COPD Current or prior history of cigarette smoking Exclusion Criteria: Medical diagnosis of asthma Chest X-ray diagnostic of significant disease other than COPD Significant condition or disease other than COPD

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Formoterol Fumarate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of lung function |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lung function, as well as vital signs |  |  | 
| Physical Exam results, adverse event reporting, etc |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, Chronic Obstructive Pulmonary Disease, formoterol
Effect of Quetiapine on Negative Symptoms and Cognition

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate the outcome on negative symptoms of schizophrenic patients during therapy with quetiapine or risperidone.

Official Title
-----------------
Efficacy of Quetiapine Compared to Risperidone on Negative Symptoms and Cognition With Regard to Underlying Neurobiological Mechanisms and Brain Activation.

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Quetiapine fumarate
* Drug: Risperidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent men and women aged 18 to 65 years with diagnosis of schizophrenia score of at least 4 CGI, PANSS negative subscale score > 21 fulfil the criterion to be right-handed for inclusion in the fMRI investigations Exclusion Criteria: Substance or alcohol dependence female patients who are pregnant, lactating or at risk of pregnancy history of organic CNS-trauma, epilepsy, meningoencephalitis, psychosurgery, instable somatic conditions risk of suicide or aggressive behaviour history of electroconvulsive therapy, Parkinson's disease, Prolactin-dependent tumor For the subset of subjects for the fMRI investigations the following additional exclusion criteria is valid as: existence of metal in the body as by cardiac pacemaker, coil, total prosthesis, metal splinter, metal articulation, metal balls.

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: Quetiapine fumarate|nan|
|Drug: Risperidone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical efficacy of both neuroleptics, especially with regard to cognitive deficits and functional brain activation between baseline and week 12 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in PANSS negative symptom total score, PANSS subscores, CGI, CGI-severity of illness, HAMD, Simpson-Angus-Scale, BPRS, specific PANSS items , Startle reflex. |  |  |