linjc16/ctgov huggingface dataset:
Gastrointestinal Toleration of Inulin Products

Study Overview
=================
Brief Summary
-----------------
The intake of inulin products has been linked to multiple health benefits which has lead to inulin fortification in food products. The investigators hypothesis that doses of up to 10 grams of inulin products should be well tolerated and not result in a significant increase in gastrointestinal symptoms.

Detailed Description
-----------------
0, 5, and 10 grams of inulin

Official Title
-----------------
Effect of Two Doses of Inulin Products on Gastrointestinal Tolerance

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

Intervention / Treatment
-----------------
* Dietary Supplement: Inulin Fiber Supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: english speaking healthy men and women 18 and 60 years of age non-smoking non-dieting BMI less than 30 standard diet consisting of no more than 15 grams fiber not taking medications Exclusion Criteria: BMI more than 30 CVD Diabetes Mellitus cancer in prior 5 years renal or hepatic disease bacterial infection in past 2 weeks more than 5 kg weight loss in past 3 months history of drug or alcohol abuse in past 6 months use of weight loss, lipid-lowering, anti-hypertensive, or anti- inflammatory medications concurrent or recent intervention study participation consumption of laxatives history of gastrointestinal disorders food allergies pregnant or lactating women

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: inulin<br>0, 5, 10 g inulin | Dietary Supplement: Inulin Fiber Supplement<br>* Orange juice fortified with 0, 5g, and 10g of 2 inulin products<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal Tolerance Score |  | Aug 2008 thru Oct 2008 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fiber, inulin, gastrointestinal tolerance
Study of Relationship Between UGT1A1 Gene Polymorphism and Toxicity and Efficacy of Irinotecan in Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out the correlation between uridine diphosphate glucuronosyl transferase 1A1(UGT1A1) gene polymorphisms and the side effect and efficacy of irinotecan in patients with small cell lung cancer.

Detailed Description
-----------------
In multiple studies of metastatic colorectal cancer,uridine diphosphate glucuronosyl transferase 1A1(UGT1A1) gene polymorphisms and its correlation with irinotecan-associated side effects have been confirmed.Data from several studies indicated an improved clinical outcome of patients who had received an irinotecan-based regimen.In order to find out the correlation between UGT1A1 gene polymorphisms and the side effect and efficacy of irinotecan in patients with small cell lung cancer,we designed this study.

Official Title
-----------------
Phase Ⅱ Study of Relationship Between UGT1A1 Gene Polymorphism and Toxicity and Efficacy of Irinotecan in Small Cell Lung Cancer

Conditions
-----------------
Small Cell Carcinoma of Lung

Intervention / Treatment
-----------------
* Drug: Irinotecan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of refractory or relapsed small cell lung cancer Physical examination and routine laboratory tests show no contraindications to chemotherapy Exclusion Criteria: Pregnant and nursing women Brain metastasis with symptoms

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: UGT1A1 wild type (6/6)<br> | Drug: Irinotecan<br>* irinotecan 180mg/m2 i.v. over 30 min d1,q2w<br>|
| Other: UGT1A1 heterozygous genotype (6/7)<br> | Drug: Irinotecan<br>* irinotecan 180mg/m2 i.v. over 30 min d1,q2w<br>|
| Other: UGT1A1 homozygous genotype(7/7)<br> | Drug: Irinotecan<br>* irinotecan 180mg/m2 i.v. over 30 min d1,q2w<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effect of chemotherapy | myelosuppression,diarrhea | within the first 30 days (plus or minus 3 days) after chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate of chemotherapy |  | tumor assessments after two cycles of chemotherapy,an expected average of 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Irinotecan, UGT1A1 Gene Polymorphisms, Small Cell Carcinoma of Lung
Screening of Nutritional Status in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Screening of nutritional status is unsolved problem in cardiac surgery. Applicability of such criteria as body mass index and albumin and screening scales (MNA, NRS-2002, SGA, SNAQ) in cardiac surgery is controversial and insufficiently studied. Furthermore, there is some known predictors of poor outcome, which closely related to nutritional status (C-reactive protein, total lymphocyte count). The aim of this study is assessment of several nutritional screening scales, objective nutritional criteria and predictors for the purpose of detection of most informative one or its combination.

Official Title
-----------------
Screening of Nutritional Status and Predictors of Adverse Outcome in Cardiac Surgery

Conditions
-----------------
Cardiovascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with cardiovascular disease operated on under cardiopulmonary bypass Exclusion Criteria: Age under 18 years Emergency Participation in other trial.

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 |
| --- | --- | --- |
| Mortality |  | Participants will be followed for the duration of hospital stay, an average of 4 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Postoperative cardiac failure, infectious complications, clinically significant arrhythmia, bleeding | Participants will be followed for the duration of hospital stay, an average of 4 weeks. | 
| Intensive care unit stay |  | Participants will be followed for the duration of hospital stay, an average of 4 weeks. | 
| Hospital stay |  | Participants will be followed for the duration of hospital stay, an average of 4 weeks. | 
| Ventilation time | Period between admission to ICU after the surgery and extubation | Participants will be followed for the duration of hospital stay, an average of 4 weeks. |
Usefulness of Early Warning Systems in Detecting Early Clinical Deterioration After Intensive Care Discharge

Study Overview
=================
Brief Summary
-----------------
The VitalPac Early Warning Score (VIEWS) scoring system, developed by Prytherch et al., Is an early warning system that aims to predict the first 24-hour mortality in emergency patients. National early warning score (NEWS) is another early warning scoring system recommended by the Royal College of Physicians in London to detect early clinical deterioration in hospitalized patients. The aim of this study was to determine the early clinical deterioration after ICU and hence the rate of admission to intensive care and to evaluate whether these two scoring systems can be used to determine early clinical deterioration in intensive care early discharge.

Official Title
-----------------
Usefulness of Early Warning Systems in Detecting Early Clinical Deterioration After Intensive Care Discharge

Conditions
-----------------
Early Clinical Deterioration, Early Warning Score

Intervention / Treatment
-----------------
* Diagnostic Test: Early Warning Score


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 18 years, discharged from the ICU and returned within 24 hours Exclusion Criteria: under 18 years old, postoperative patients, pregnant women

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 |
| --- |
|Diagnostic Test: Early Warning Score|National early warning score (NEWS) is another early warning scoring system recommended by the Royal College of Physicians in London to detect early clinical deterioration in hospitalized patients|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients recovered due to early clinical deterioration within the first 24 hours after ICU discharge | The aim of this study is to determine the early clinical deterioration in the first 24 hours after ICU discharge and therefore the rate of admission to ICU. | six month |
Novel Epothilone (BMS-247550) in Patients With Metastatic Breast Cancer (MBC)

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to assess the response rate of the investigational drug BMS-247550 (Ixabepilone) in women with metastatic breast cancer who are refractory to an anthracycline, a taxane, and capecitabine.

Official Title
-----------------
Phase II Study of Novel Epothilone (BMS-247550) in Patients With MBC Who Are Refractory to an Anthracycline, a Taxane, and Capecitabine

Conditions
-----------------
Breast Cancer, Metastases

Intervention / Treatment
-----------------
* Drug: Ixabepilone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have received all 3 drugs- an anthracycline, taxane, and capecitabine (alone or in combination) and be resistant No more than 3 prior chemotherapy regimens in the metastatic setting Must have at least one target lesion that is radiographically measurable Good performance status No history of or current brain or leptomeningeal disease

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Ixabepilone<br>* Solution, IV, 40 mg/m2, every 21 days, extended, until PD or discontinued for other reasons.<br>* Other names: BMS-247550;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate as determined by the IRRC |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression, duration of response, overall survival |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metastatic Breast Cancer
Study Evaluating Single Ascending Doses Of ILS-920

Study Overview
=================
Brief Summary
-----------------
This is a first-in-human study of ILS-920. This study will provide an initial assessment of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ILS-920 after administration of ascending single intravenous (IV) doses to healthy adult subjects.

Official Title
-----------------
Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of ILS-920 Administered Intravenously To Healthy Adult Subjects

Conditions
-----------------
Acute Ischemic Stroke

Intervention / Treatment
-----------------
* Drug: ILS-920


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women of nonchildbearing potential Aged 18 to 50 years inclusive at screening. Exclusion Criteria: Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. History of drug abuse within 1 year before study day 1.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ILS-920 | Drug: ILS-920<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety based on vital sign evaluations, 12-lead ECGs, cardiac rhythm monitoring and routine lab tests. |  | 48 hours after study drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics will measure the extent and rate of Absorption, Distribution, Metabolism and Excretion of the drug in the body. |  | 48 hours after study drug administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Ischemic Stroke
Transcervical Myoma Biopsy Video

Study Overview
=================
Brief Summary
-----------------
To describe the fertility-sparing management of an atypical uterine myoma. Step-by-step video explanation of transcervical biopsy using transabdominal ultrasound guidance, highlighting tips and tricks. Patient consent was obtained for publication of the case.

Official Title
-----------------
Fertility-sparing Management of a Suspicion of Leiomyosarcoma: Avoiding Hysterectomy by Performing Transcervical Myoma Biopsy

Conditions
-----------------
Atypical, Myoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: age >18 years old WOMAN WITH DESIRE FOR PREGNANCY ATYPICAL MYOMA Exclusion criteria: - age < 18 years old

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

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 |
| --- | --- | --- |
| Evaluation of video | BIOPSY TECHNIQUE DESCRIBED BY VIDEO | day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
YOUNG WOMAN WITH DESIRE FOR PREGNANCY, ATYPICAL MYOMA, FERTILITY PRESERVATION, BIOPSY
Progressive Collective-exercise Program on the Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesized that an eight-week collective group exercise program would improve pain, quality of life and functional capacity in patients with knee osteoarthritis (KOA) compared with those receiving no exercise intervention.

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Other: Collective group exercise program in patients with KOA
* Other: Orientation (without exercise)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: symptomatic and moderate to severe medical diagnostic of KOA. Subjects with normal cognitive functions and no restriction to perform physical activities were recruited from the hospital's KOA database and eligible to participate if they had presented: Lequesne questionnaire criteria (5 - 13.5), knee pain score between 3 and 7 (on a 0 -10 Visual Analogue Scale), stable doses of non-steroidal anti-inflammatory drugs (NSAIDs) and no regular physical exercise or use of canes in the months prior to the study. Exclusion Criteria: Symptomatic heart disease; symptomatic disease of the lower limbs (other than KOA); symptomatic lung disease; severe systemic disease; severe psychiatric illness; regular physical exercise (three or more times per week for at least 3 months); drug injection in the knee in the previous 3 months; physiotherapy on the lower limbs in the previous 3 months and absence in two consecutive training sessions or three nonconsecutive sessions

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Collective group exercise program in patients with KOA<br>Collective exercises program for patients with osteoarthritis and orientation about this disease | Other: Collective group exercise program in patients with KOA<br> <br> |
| Active Comparator: Control group (without exercise)<br>Orientation about osteoarthritis disease but without any exercise program | Other: Orientation (without exercise)<br>* Orientation about osteoarthritis disease but without any exercise program<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | pain assessed by Visual Analogue Scale | Eight weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life | quality of life assessed by SF-36 questionnaire | Eight weeks |
Oral Bioavailability of GLPG0555 in Different Solid Formulations

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare the pharmacokinetics of a solid capsule formulation of GLPG0555 with a nanosuspension, and to assess safety and tolerability of a single dose of GLPG0555.

Official Title
-----------------
A Randomized, Open Label, 3-way Crossover Study to Compare the Oral Bioavailability of GLPG0555 After Single-dose Intake in Healthy Subjects as a Solid Dispersion Formulation, With and Without Food, Relative to a Nanosuspension Formulation

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

Intervention / Treatment
-----------------
* Drug: GLPG0555 solid dispersion
* Drug: GLPG0555 nanosuspension


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy male BMI between 18-30 kg/m², inclusive. Exclusion Criteria: significantly abnormal platelet function or coagulopathy smoking drug or alcohol abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GLPG0555 solid dispersion, fasting<br>50 mg as solid dispersion capsule, in fasting condition | Drug: GLPG0555 solid dispersion<br>* solid dispersion capsules, 50 mg, single dose<br>|
| Experimental: GLPG0555 solid dispersion, fed<br>50 mg as solid dispersion capsule, after breakfast | Drug: GLPG0555 solid dispersion<br>* solid dispersion capsules, 50 mg, single dose<br>|
| Experimental: GLPG0555 nanosuspension, fed<br>50 mg as nanosuspension, given after breakfast | Drug: GLPG0555 nanosuspension<br>* Nanosuspension, 50 mg, single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioavailability of solid formulation |  | 72 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of single doses of GLPG0555 |  | up to 10 days postdose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, Tolerability, Pharmacokinetics