linjc16/ctgov huggingface dataset:
Study Evaluating FXR-450 in Healthy Japanese Men

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of a single dose of FXR-450 in healthy Japanese men.

Detailed Description
-----------------
This study was terminated on May 2008. The reason for termination was due to pharmacokinetics issues. The decision to terminate was not due to safety and tolerability.

Official Title
-----------------
Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of FXR-450 Administered Orally to Healthy Japanese Male Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: FXR-450
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men aged 20 to 45 years. Healthy as determined by the investigator. Nonsmoker or smoker of fewer than 10 cigarettes per day. Exclusion Criteria: A history or active presence of clinically important medical disease. Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article (e.g., resection of liver, kidney, gallbladder, or gastrointestinal tract).

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Drug: FXR-450 | Drug: FXR-450<br>* capsule, single oral doses from 10 mg to 450 mg<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* capsule similar to active drug<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome is safety and tolerability. |  | 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  | 4 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy subjects
Systems-oriented School Healthy Weight Promotion Based on NASA Mission X Campaign

Study Overview
=================
Brief Summary
-----------------
This study assessed the effect of the National Aeronautics and Space Administration's (NASA's) Mission X (MX) program on children's knowledge, attitude, and practice of healthy eating and active living (HEAL) and weight status in rural elementary schools in Taiwan.

Official Title
-----------------
Systems-oriented School Healthy Weight Promotion: A Pilot Controlled Intervention Study in Remote Areas School Based on NASA Mission X Campaign

Conditions
-----------------
Pediatric Obesity

Intervention / Treatment
-----------------
* Behavioral: Adapted NASA's Mission X program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The thirteen public elementary schools in Tamsui, Sanzhi and Shimen Districts, New Taipei City, Taiwan, were the target population. Schools that were in distance within 30 minutes by car from Mackay Medical College were approached. Eight schools agreed to participate. All 3rd and 4th graders of the participating schools were invited to the evaluation program. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adapted NASA's Mission X program<br>Adapted NASA's Mission X program for the intervention group | Behavioral: Adapted NASA's Mission X program<br>* 8 Weeks Adapted National Aeronautics and Space Administration's (NASA's) Mission X (MX) program<br>|
| No Intervention: Mission X Control<br>no intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index | weight status, BMI-Z score | 8-weeks |
Maternal and Fetal Outcomes in Pregnant Women With COVID -19,a Cross Sectional Study

Study Overview
=================
Brief Summary
-----------------
The spread of a new coronavirus (SARS-CoV-2) from Wuhan, China, has been fast, and the World Health Organization (WHO) declared a pandemic on March 11th, 2020 .It has now spread worldwide and is one of the most severe public health threats.The clinical characteristics of COVID-19 and the likelihood of transmission vertically or during delivery in pregnant women are still unknown.

Detailed Description
-----------------
In this cross sectional study,the following questions require immediate attention: whether COVID-19 symptoms in pregnant women differ from symptoms in non-pregnant women; whether disease complications and mortality rates are higher in pregnant women than in non-pregnant women; and whether there is a risk of premature delivery, foetal mortality, or even vertical transmission of the disease. These questions must be answered in order to plan optimal obstetrical management for pregnant women with COVID-19

Official Title
-----------------
COVID-19 and Pregnancy Maternal and Fetal Outcomes,A Retrospective Cross Sectional Study

Conditions
-----------------
COVID-19 Pandemic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women of any gestational age with confirmed COVID 19 diagnosis attended and admitted at inpatient ward for management and follow up from April 2020 to December 2021at Kasr El Ainy hospital,Cairo university Exclusion Criteria: there is no exclusion criteria
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
| Outcomes of Pregnancy with COVID-19 | Prevalence of maternal and fetal morbidities and adverse obstetrical outcomes among pregnant women with COVID-19 diagnosis. | 32 months |
Aspirin and the Risk of Microscopic Hematuria in Asymptomatic Screened Population

Study Overview
=================
Brief Summary
-----------------
Aspirin can increase the risk of bleeding tendency. However, correlation between aspirin treatment and hematuria in general population is not well known. The investigators will evaluate whether daily use of aspirin increase the risk of microscopic hematuria in healthy large screened populations.

Conditions
-----------------
Asymptomatic General Population, Microscopic Hematuria

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 20 years, male or female Exclusion Criteria: No result of urinalysis No record of medical history (including medication)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 89 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 |
| --- | --- | --- |
| Incidence rate of the microscopic hematuria | >4 RBC/HPF in urine microscopy | at the screening | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection rate of significant cause for microscopic hematuria | Among participants who had microscopic hematuria at the screening By imaging study or cystoscopy At the screening or within 12 months after screening Significant cause for microscopic hematuria urinary stone renal mass (benign or malignant / not simple cyst) urothelial cancer other lesions (clinically relevant lesions determined by researchers) | whitin 12 months after screening | 
| Incidence rate of persistent microscopic hematuria | Among participants who had microscopic hematuria at the screening Determined by repeated urine microscopy | within 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aspirin, screening, microscopic hematuria
Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)

Study Overview
=================
Brief Summary
-----------------
Demonstrate the efficacy of High Intensity Focused Ultrasound in the treatment of the breast fibroadenoma.

Official Title
-----------------
Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU): a Feasibility Study

Conditions
-----------------
Breast Fibroadenoma

Intervention / Treatment
-----------------
* Device: Ultrasonic ablation device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: One breast fibroadenoma with diagnosis based on: Clinical examination Ultrasound image For women older than 35 years: mammogram with BI-RADS score < 3 Histologic confirmation by two independent readers Fibroadenoma size between 1 cm and 3 cm at its largest dimension (measured by ultrasound) Exclusion Criteria: Patient pregnant or lactating Bi-RADS score > 2 at the mammogram, or microcalcifications within the lesion. History of breast cancer or history of laser or radiation therapy to the target breast Breast implants Breast cyst Fibroadenoma not clearly visible on the ultrasound images (in B mode) Patient participating in other trials using drugs or devices

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIFU<br> | Device: Ultrasonic ablation device<br>* One or two HIFU procedures<br>* Other names: TH-One;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of breast fibroadenoma volume at ultrasonography |  | 12 months |
Disorders of Systemic Glucose Balance

Study Overview
=================
Brief Summary
-----------------
We wish to identify people with hypoglycemia (low blood sugar) and ultimately determine why the blood sugar levels are so low. To do so, we will contrast the responses of patients suspected to have hypoglycemia with those of healthy subjects during standardized tests. Those tests may include: 1) a controlled hypoglycemia produced by administration of insulin, a blood sugar-lowering hormone, and sugar, 2) a formula meal, and 3) a period of up to 72 hours without food.

Conditions
-----------------
Hypoglycemia

Intervention / Treatment
-----------------
* Procedure: Controlled hypoglycemia using insulin
* Procedure: formula meal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with suspected hypoglycemia Healthy subjects (controls) Absence of known macrovascular disease or of known CNS disease by medical history, physical examination or ECG (exclusions for induced hypoglycemia) Ability to give informed consent

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

Design Details

Primary Purpose: Diagnostic


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Controlled hypoglycemia using insulin|nan|
|Procedure: formula meal|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
An Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs

Study Overview
=================
Brief Summary
-----------------
This observational study will evaluate in clinical practice the change in Disease Activity Score (DAS28) in patients with rheumatoid arthritis and an inadequate response to DMARDs who are initiated on treatment with RoActemra/Actemra (tocilizumab). Data will be collected from eligible patients (on 8 mg/kg or 4 mg/kg intravenously every 4 weeks, with or without methotrexate) for 12 months.

Official Title
-----------------
DAS Evaluation of RA Activity in Patients Treated With Tocilizumab

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Moderate to severe active rheumatoid arthritis Inadequate response or intolerance to previous therapy with one or more traditional DMARDs Exclusion Criteria: Pregnant or lactating women Active infection Positive for hepatitis B, hepatitis C or HIV infection Concomitant anti-TNF drugs Contraindications to treatment with 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 |
| --- | --- | --- |
| Disease activity score (DAS28) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DAS 28 (subgroup on monotherapy) |  | 12 months | 
| DAS 28 (subgroup on 4 mg/kg dose) |  | 12 months | 
| Safety: Incidence of adverse events |  | 12 months |
A Post Market Study Evaluating the Safety, Device Perfomance and Possible Emergent Risks of Celotres in Preventing Recurrence in Keloid Lesions Treated Adjunctive to Surgical Excision

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to actively gather additional information on safety, device performance and possible emergent risks following the use of Celotres in a post-market setting when used to reduce the recurrence rate, volume, appearance and/or symptoms associated with keloid scarring in subjects undergoing surgical excision of keloids as compared to the scientific literature.

Official Title
-----------------
A Post Market Study Evaluating the Safety, Device Perfomance and Possible Emergent Risks of Celotres in Preventing Recurrence in Keloid LEsions Treated Adjunctive to suRgical Excision. PMCS: EURO-KLEAR

Conditions
-----------------
Earlobe Keloids

Intervention / Treatment
-----------------
* Device: Celotres


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients electing to undergo keloid excision procedure Patients able and willing to give written informed consent Exclusion Criteria: Patients with a known or potential risk of allergy or sensitivity to products or substances containing porcine gelatin.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Celotres<br>Celotres following surgical removal of earlobe keloid. | Device: Celotres<br>* Celotres following surgical removal of earlobe keloid.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of device related adverse events | Device safety is defined as the incidence of device related adverse events. | Assessed at treatment, suture removal, Months 1, 3, 6, 9 and 12 | 
| Recurrence of keloid post scar excision | Proportion of subjects with recurrence of keloid scar post excision defined as the presence of scar tissue volume >0.3cc | Assessed at 1, 3, 6, 9 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient and Observer Scar Assessment Scale (POSAS) |  | Assessed at Pre-treatment, Months 1, 3, 6, 9 and 12 | 
| Subject Dermatology Life Quality Index (DLQI) |  | Assessed at Pre-treatment, Months 1, 3, 6, 9 and 12 | 
| Device Performance Evaluation | Questions related to packaging integrity and successful administration of product as assessed by the Principal Investigator. | Assessed at Day 1 |
Taxol Carboplatin and Erythropoetin

Study Overview
=================
Brief Summary
-----------------
Time to progression (physical examination and radiologic imaging

Official Title
-----------------
Carboplatin With Following Taxol® Therapy Under Additional Application of Epoetin Alfa (ERYPO ®) With Female Patients With Advanced Ovarian Cancer FIGO IA/G3 - IV

Conditions
-----------------
Ovarian Cancer

Intervention / Treatment
-----------------
* Drug: Paclitaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with primary ovarian cancer ECOG- 0-2 Age >= 18 no chemotherapy, radiation or immunotherapy in medical history for ovarian cancer adequate bone marrow, liver and kidney reserve: leukocytes ≥ 2.0 x 109/l, platelets ≥ 100 x 109/l, bilirubin <= 2,0 mg%, creatinine <= 1,5 mg% or creatinine clearance ≥ 60 ml/ min, hemoglobin ≥ 9 g/ dl SGOT, SGPT an AP within 3 fold of the reference laboratory's normal range written informed consent Exclusion Criteria: before-existing heart illness, Cardiac infarct within last 6 months Radiotherapy within 4 weeks for study entry Patients in pregnancy or breast feeding (in premenopausal women anticonception has to be assured: intrauterine devices, surgical methods of sterilization, or, in hormone insensitive tumors only, oral, subcutaneous or transvaginal hormonal, non-estrogen containing contraceptives)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paclitaxel<br> | Drug: Paclitaxel<br>* 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival. Progression is Defined According WHO-criteria as Appearance of Any New Lesion or Increase of Existing Lesions by at Least 25% | Time to progression | every 3 months for up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity | defined as hematological and non-hematological adverse events of grade >= grade 1 | after every cycle during therapy phase and after every 3 months during follow-up, for up to 3 years |
Evaluation of the Ovarian Reserve in Infertile Patients With Endometriosis

Study Overview
=================
Brief Summary
-----------------
Comparison between Ovarian reserve markers in patients with minimal/mild endometriosis and patients with tubal factor infertility

Detailed Description
-----------------
Comparison between Ovarian reserve markers (laboratory or us) in patients with minimal/mild endometriosis and patients with tubal factor infertility including: Cycle Day 2 or 3 FSH and E2, Serum AMH and antral follicular count

Official Title
-----------------
Evaluation of the Ovarian Reserve in Infertile Patients With Endometriosis

Conditions
-----------------
Endometriosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-35 years of age. Written and signed informed consent by the patient to participate in the study. Patients with regular menses, both ovaries, serum TSH within normal range, body mass index (BMI) <30 kg/m2 with normal sperm analysis of the husband. Exclusion Criteria: Patients with previous endocrine disorders. Cases in which the cause for infertility was other than endometriosis (except for patients with tubal obstruction, in the control group). Patient with previous surgery for endometriosis.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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 |
| --- | --- |
| Minimal or mild endometriosis<br>Patients with minimal or mild endometriosis diagnosed via laparoscopy. | |
| Tubal obstruction without endometriosis<br>Patients with tubal obstruction due to infection or adhesion with absent evidence for endometriosis on laparoscopy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of ovarian reserve in the 2 groups | Serum AMH and antral follicular count (AFC) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other Hormonal parameters | Cycle day 2 or 3 FSH and E2 | 2 years |