linjc16/ctgov huggingface dataset:
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Cytochalasin B

Study Overview
=================
Brief Summary
-----------------
Vienna Consensus has identified 10% damage rate after ICSI as a competency value. Despite the highest quality embryologists doing ICSI, degeneration sometimes occurs due to oocyte factors such as the fragile membrane, etc. Cytochalasin B serves to facilitate spindle or pronuclear transfer procedures helping to reduce the damage rate with no harm reported. Using Cytochalasin B during ICSI could serve to rescue some oocytes from the degeneration allowing for more chances of viable zygotes,

Official Title
-----------------
Cytochalasin B Supplementation to ICSI Handling Medium

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

Intervention / Treatment
-----------------
* Other: Cytochalasin B use in ICSI handling medium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All ICSI candidates patients Exclusion Criteria: No exclusion

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Handling Medium Supplemented with Cytochalasin B<br> | Other: Cytochalasin B use in ICSI handling medium<br>* A medium with in-house supplementation of Cytochalasin B to decrease oocyte degeneration after ICSI and improve survival rate<br>|
| No Intervention: Handling Medium as it is.<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oocyte survival rate | number of survived oocyte after intracytoplasmic sperm injection | 6 days of culture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fertilization rate | number of fertilized oocytes per metaphase II injected | 6 days of culture | 
| blastocyst formation rate | number of formed blastocyst per fertilized oocyte | 6 days of culture | 
| embryo utilization rate | number of embryo transferred added to number of those cryopreserved per fertilized oocyte | 6 days of culture | 
| clinical pregnancy rate | number of women with a heartbeat at week 4 or more after embryo transfer | three months | 
| ongoing pregnancy rate | number of women with continued pregnancy after twelve weeks of gestation | four months |
An Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD Patients

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, 6 months open label safety extension study for all patients who are willing and eligible to continue from the pivotal, double-blind S308.3.001 trial

Official Title
-----------------
An Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD Patients

Conditions
-----------------
Early Stage Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: Pardoprunox


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have completed S308.3.001 trial Exclusion Criteria: Patients with medically relevant abnormal findings (ECG, physical examination, AEs) at end of the maintenance phase (visit M6, week 24) of study S308.3.001

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Pardoprunox<br>* 12-42 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: laboratory data, adverse events, vital signs, ECG |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UPDRS parts 1, 2 and 3, CGI-severity, CGI-improvement, PDQ-39 total score: all change from baseline |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's disease
Efficacy and Safety of Clevudine Compared With Adefovir in Patients With Chronic Hepatitis Due to Hepatitis B Virus

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to compare in nucleoside treatment-naïve subjects, the efficacy and safety of clevudine 30 mg once daily versus adefovir 10 mg once daily, each as monotherapy, for 48 weeks, 72 weeks, and 96 weeks.

Official Title
-----------------
A Multi-Center, Randomized, Double-Blind, Active-Control, 96 Week, Phase III Trial of the Efficacy and Safety of Clevudine Compared With Adefovir at Weeks 48 and 96 in Nucleoside Treatment-Naïve Patients With HBeAg Negative Chronic Hepatitis Due to Hepatitis B Virus

Conditions
-----------------
Chronic Hepatitis, Hepatitis B

Intervention / Treatment
-----------------
* Drug: Clevudine
* Drug: Adefovir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nucleoside treatment-naïve subjects of either gender, females who are non-pregnant and non-lactating, aged 16 years or older (or the legal age of consent as allowed by local regulations), with compensated hepatic function despite a diagnosis of chronic HBeAg negative hepatitis B infection (i.e., based on serological, virological and histological markers) will be eligible for this study. Subjects entering the study with an historical biopsy will have chronic hepatic inflammatory injury at screening (Knodell HAI score ≥ 4 and modified Ishak fibrosis score ≤ 5). The number of subjects entering the study with an Ishak fibrosis score of 5 will be limited to approximately 10%. If applicable, subjects must cease previous treatment with any form of alpha interferon 12 months prior to baseline. For eligibility, subjects must meet the laboratory criteria for total bilirubin, prothrombin time, serum albumin, platelet count, absolute neutrophil count, ANA titer and have a creatinine clearance of ≥ 50 mL/min. Exclusion Criteria: Subjects participating in a clinical trial or receiving an investigational agent for any reason within 60 days of baseline will be excluded. Subjects with clinically significant concomitant diseases will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Clevudine|nan|
|Drug: Adefovir|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
-----------------
Nucleoside Treatment-Naïve Patients with HBeAg Negative Chronic Hepatitis due to Hepatitis B Virus, hepatitis b virus
Use of Mobile Phones for Thermal Imaging of the Chest to Save Lives of Children With Pneumonia in Nagpur, India

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if thermal images can be used instead of a chest x-ray to diagnose bacterial pneumonia in children with signs and symptoms of pneumonia in Nagpur, India. More specifically, the objectives of the study are: 1) to determine if thermal imaging, using a commercial thermal camera can accurately detect the presence of bacterial pneumonia in children receiving a chest x-ray to rule out pneumonia; 2) to evaluate the use of thermal imaging to monitor the course and resolution of pneumonia in children diagnosed with pneumonia; and 3) to determine if thermal imaging can accurately diagnose sites of infection that are suspected to be related to the pneumonia.

Official Title
-----------------
Use of Mobile Phones for Thermal Imaging of the Chest to Save Lives of Children With Pneumonia in Nagpur, India

Conditions
-----------------
Infections - Bacterial, Pneumonia - Bacterial

Intervention / Treatment
-----------------
* Device: FLIR ONE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or younger patient at DAGA Memorial Hospital, Nagpur, India had chest x-ray within last 24 hours consent obtained from one parent assent obtained if child is 8 years or older Exclusion Criteria: thermal image cannot be done within 24 hours of chest x-ray

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thermal Imaging<br>imaging using a thermal camera | Device: FLIR ONE<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnosis of bacterial pneumonia | Thermal imaging will be used and compared to the chest x-ray taken within 24 hours to see if bacterial pneumonia is present | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnosis of additional site of infection possibly related to bacterial pneumonia | Thermal imaging will be used to image other potential sites of infection suspected of being related to the bacterial pneumonia if suspected by physician | within same hospital stay | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
imaging, diagnostic, pediatrics
GW572016 In Patients With Advanced Or Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the efficacy and safety of GW572016 in patients with refractory breast cancer and consists of two cohorts of patients. Patients in Cohort A must have ErbB2 overexpressing tumors while patients in Cohort B must have non-ErbB2 overexpressing tumors. Patients eligible for this study must have advanced metastatic breast cancer who have previously received treatment with anthracycline and taxane.

Official Title
-----------------
Phase II Clinical Study of GW572016 in Patients With Advanced or Metastatic Breast Cancer

Conditions
-----------------
Neoplasms, Breast

Intervention / Treatment
-----------------
* Drug: Tykerb


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed advanced (IIIb or Stage IV) breast cancer who have progressed on prior anthracycline and taxanes containing regimens + trastuzumab for cohort A patients. Patients must have adequate blood, liver, and kidney function and either be fully active or restricted only in performing strenuous activity. Female patients of child-bearing potential must be willing to abstain from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication or be willing to consistently and correctly use an acceptable method of birth control. Exclusion Criteria: Patients with certain heart problems.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lapatinib 1500mg daily<br>Subjects will self-administer lapatinib 1500 mg orally once daily. | Drug: Tykerb<br>* lapatinib 1500mg daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate tumor response rate in both cohort A (ErbB2 overexpressors) and in cohort B (ErbB2 non-overexpressor) population when treated with GW572016 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical benefitTime to tumor responseLength of responseTime to progression of cancer4 and 6 month progression free survivalOverall survival as well as specific biomarkers in tumor tissue |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lapatinib, metastatic breast cancer, trastuzumab (Herceptin), Stage IV breast cancer, ErbB2, ErbB1
Study of the Effects of an Oral Nitric Oxide Supplement on Blood Pressure in Prehypertensive Adults

Study Overview
=================
Brief Summary
-----------------
Oral supplementation of Neo40(TM), a nitrate lozenge, will reduce blood pressure in healthy adults with clinical prehypertension.

Official Title
-----------------
Study of the Effects of an Oral Nitric Oxide Supplement on Functional Capacity and Blood Pressure in Healthy Adults With Prehypertension

Conditions
-----------------
Prehypertension

Intervention / Treatment
-----------------
* Dietary Supplement: Nitric Oxide supplement
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults between the ages of 18 to 80 years Two blood pressure readings of >/=135/80 mmHg at rest, thus representing prehypertension Informed consent Exclusion Criteria: Existence of any significant internal or cardiovascular disease; Current use of any antihypertensive medication. Inability to give informed consent, or fill out standard questionnaires or inability to follow up clinically.

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nitric Oxide supplement<br> | Dietary Supplement: Nitric Oxide supplement<br>* Lozenge consisting of beetroot and 75 mg caffeine<br>* Other names: Neo40 Daily;|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Same form factor and flavor as test lozenge but contains no active ingredients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Systolic and Diastolic Blood Pressure Readings | Two blood pressure readings at rest will be taken at baseline and again after thirty days during the follow-up appointment. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Functional Capacity | Participant will take a six minute walk test at baseline and again after thirty days during the follow-up appointment. Achieved distances will be measured and recorded. | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prehypertension, Nitric Oxide, Blood Pressure, Functional Capacity, Quality of Life
Fetal Parenchymatic Evaluation (Liver, Spleen) Using T2* Sequences

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to prospectively evaluated the T2* values of normal feti.A standardized scale of T2* values for fetal and neonatal iron organ overload have yet to be reported or devised.

Detailed Description
-----------------
The purpose of this study is to prospectively evaluate the T2* values of normal feti. This study will be offered to mothers undergoing fetal MRI for any indication. Subjects will be required to sign an informed consent from. The addition of T2* sequences will add 2-4 minutes to the whole scan, not exposing the mother or the fetus to ionizing radiation or the administration of contrast material. A standardized scale has been created and multi-center studies have been conducted using different vendor scanners in order to verify the consistency of these scale. T2 and T2* sequences have been addressed anecdotally in the literature as non invasive options for the evaluation fetal iron deposition . However, a standardized scale of T2* values for fetal and neonatal iron organ overload have yet to be reported or devised.

Official Title
-----------------
Fetal Parenchymatic Evaluation (Liver, Spleen) Using T2* Sequences.

Conditions
-----------------
Iron Overload

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any MRI study for fetus Exclusion Criteria: Known iron deposition problem in the mother of fetus
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver, spleen , T2* , MRI, fetus
An Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Treated With Glucocorticoids

Study Overview
=================
Brief Summary
-----------------
This prospective, observational, multicenter study will assess the efficacy and safety of RoActemra/Actemra (tocilizumab) on the use of glucocorticoids in patients with moderate to severe rheumatoid arthritis and an inadequate response to previous disease-modifying antirheumatic drugs or anti-TNF. Data will be collected for 36 weeks.

Official Title
-----------------
A Prospective Observational Study to Assess the Impact of RoActemra® on the Use of Glucocorticoids in Patients With Rheumatoid Arthritis Treated With the Standard of Care.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults patients, over 18 years of age Patients with moderate to severe rheumatoid arthritis (RA) Patients on a stable dose of prednisone or equivalent (>/=7.5 mg/day) for at least 4 weeks before study inclusion Exclusion Criteria: Patients previously treated with RoActemra/Actemra Any contraindication to RoActemra/Actemra

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients on treatment with RoActemra/Actemra who achieve prednisone (or equivalent) dose reduction of </= 5mg/day |  | Week 36 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in glucocorticoid dose |  | Week 36 | 
| Change from baseline in corticosteroid dose |  | Week 36 | 
| Proportion of patients treated with RoActemra/Actemra who reach Week 36 with a reduced glucocorticoid dose |  | Week 36 | 
| Proportion of patients treated with RoActemra/Actemra not receiving glucocorticoids |  | Week 36 | 
| Proportion of concomitant disease-modifying anti-rheumatic drug (DMARD) use |  | Week 36 | 
| Proportion of patients with inadequate response to prior treatment with disease-modifying antirheumatic drugs at baseline, who reach a prednisone (or equivalent) dose reduction of </= 5 mg/day |  | Week 36 | 
| Proportion of patients with inadequate response to prior treatment with anti-TNF at baseline, who reach a glucocorticoid dose reduction of </= 5 mg/day |  | Week 36 | 
| Proportion of patients meeting the physician's recommendaitons for glucocorticoid dose reduction |  | Week 36 | 
| Percentage change in Disease Activity Score 28 (DAS28) |  | Week 36 | 
| Percentage change in Simplified Disease Activity Index (SDAI) score |  | Week 36 | 
| Safety: Incidence of adverse events |  | 36 weeks |
Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload

Study Overview
=================
Brief Summary
-----------------
Thalassemic patients often suffer from iron overload due to frequent blood transfusion. Oral iron chelators reduce iron overload in transfusion dependent patients. The aim of this study is to compare the efficacy and safety of osveral and desferal in transfusional iron overload patients with β-Thalassemia and intermediate Thalassemia in Bandarabbas.

Detailed Description
-----------------
This is a double blinded randomized controlled trial on Efficacy and safety of Osveral and Desferal in thalassemic patients.

Official Title
-----------------
Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload Patients With β-Thalassemia and Intermediate Thalassemia in Bandarabbas

Conditions
-----------------
Thalassemia, Iron Overload, Transfusion Related Complications

Intervention / Treatment
-----------------
* Drug: osveral
* Drug: Desferal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed intermedia or major thalassemia More then 2 years old Serum Ferritin level > 1000 Normal Creatinine and Complete Blood Count (CBC) Exclusion Criteria: HCV, HBV or HIV positive patients

Ages Eligible for Study
-----------------
Minimum Age: 2 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Osveral<br>20 mg/kg oral osveral daily | Drug: osveral<br>* receive 20 mg/kg daily orally<br>* Other names: deferasirox;|
| Active Comparator: desferal<br>40mg/kg desferal for 6 nights in a week subcutaneously | Drug: Desferal<br>* 40-50mg/Kg for 6 nights in each week subcutaneously<br>* Other names: Deferoxamine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ferritin level | ferritin level in months 4 and 8 of the study | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin level | hemoglobin level at months 4 and 8 off the study. | 8 month | 
| Drug side effects | Leuckopenia, thrombocytopenia | 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thalassemia, Iron overload, transfusion, osveral, desferal