linjc16/ctgov huggingface dataset:
Study in Unsettled Infants Experiencing Feeding Intolerance

Study Overview
=================
Brief Summary
-----------------
Multinational, multicenter, clinical trial. To evaluate the effect of an experimental formula on GI symptoms and associated behaviors in unsettled infants with parent-reported feeding intolerance

Detailed Description
-----------------
The purpose of the present study is therefore to evaluate the effect of an experimental formula in an unsettled formula-fed infant population whose parents are considering switching formulas due to perceived feeding intolerance.

Official Title
-----------------
Effect of an Experimental Infant Formula in Unsettled Infants Experiencing Feeding Intolerance

Conditions
-----------------
Feeding Disorder

Intervention / Treatment
-----------------
* Other: Experimental Formula
* Other: Standard control formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Full term infants, singleton, healthy at birth Infants of parent(s)/LAR who have previously made the decision to exclusively formula feed their infant. Infants exclusively consuming a standard formula for a minimum of 3 consecutive days prior to enrolment. Infant's parent(s)/LAR are of legal age of consent and are willing and able to fulfil the requirements of the study protocol. Exclusion Criteria: Infants who are consuming any amount of supplemental human milk Infants who are consuming weaning foods or beverages other than infant formula Infants with known cow's milk allergy or family history of siblings with documented cow's milk protein intolerance/allergy Infants who have a medical condition or history that could cause or contribute to feeding intolerance Infants who received any other investigational intervention or who have participated in another clinical trial prior to enrolment

Ages Eligible for Study
-----------------
Minimum Age: 30 Days
Maximum Age: 90 Days

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Formula<br>Experimental Formula | Other: Experimental Formula<br>* Experimental formula<br>|
| Other: Standard Formula<br>Standard Control formula | Other: Standard control formula<br>* Standard Infant formula<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline to 14 days in fuss-cry behavior | fuss-cry behavior per 24 hours | from baseline to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to 14 days in GI symptoms |  | from baseline to 14 days |
Early Patient Access Treatment Use Protocol CA204-220

Study Overview
=================
Brief Summary
-----------------
The objective of this expanded access program is to provide treatment with elotuzumab in combination with lenalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma at Japanese sites where licensed physicians determine clinical need.

Official Title
-----------------
An Expanded Access Program for Elotuzumab in Combination With Lenalidomide Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma in Japan

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: Elotuzumab
* Drug: Lenalidomide
* Drug: Dexamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria Men and women 20 years and older. Active, relapsed or refractory multiple myeloma by International Myeloma Working Group (IMWG) criteria as assessed by the treating physician and have received at least 1 prior line of multiple myeloma therapy. Progression from a most recent line of therapy. Prior lenalidomide exposure is permitted only if they fulfill all of the following:. i) Were not refractory to prior lenalidomide, defined as no progression while receiving lenalidomide (induction dose) or within 60 days of last dose of lenalidomide. Patients progressing on lenalidomide maintenance dose are eligible for enrollment. ii) Patient did not discontinue lenalidomide due to a Grade ≥ 3 related AE. Exclusion Criteria All Adverse Events of any prior chemotherapy, surgery, or radiotherapy not resolved to NCI CTCAE (v. 3.0) Grade ≤ 2. Significant cardiac disease as determined by the treating physician including cardiac amyloidosis. HIV infection or active hepatitis A, B, or C. Any medical conditions that, in the attending physician's opinion, would impose excessive risk to the patient. Other protocol-defined Inclusion/Exclusion criteria apply.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Elotuzumab|Specified dose on specified days|
|Drug: Lenalidomide|Specified dose on specified days|
|Drug: Dexamethasone|Specified dose on specified days|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Semen Analysis and Insight Into Male Infertility

Study Overview
=================
Brief Summary
-----------------
Semen analysis is the cornerstone for the valuation of the male partner in the infertile couples. This test has been standardized throughout the world through the World Health Organization (WHO) since the1970s by producing, editing, updating, and disseminating a semen analysis manual and guidelines.

Detailed Description
-----------------
A retrospective study to assess the frequency of male factor infertility in the last years.

Official Title
-----------------
Semen Analysis and Insight Into Male Infertility

Conditions
-----------------
Male Infertility

Intervention / Treatment
-----------------
* Diagnostic Test: semen fluid analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infertile males Exclusion Criteria: suergery

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: semen fluid analysis|semen fluid analysis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Count and motility | low count | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infertility;, male, semen
Effect of Suspension Training in the Elderly

Study Overview
=================
Brief Summary
-----------------
This study aimed to analyze the effects of a 12-week suspension exercise training programme on handgrip strength (HG) and anthropometric and bioelectrical impedance parameters in older adults.

Official Title
-----------------
Changes in Phase Angle and Handgrip Strength Induced by Suspension Training in Older Women: A Randomized Controlled Trial

Conditions
-----------------
Effects of Suspension Training

Intervention / Treatment
-----------------
* Other: Physical activity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non-hypertensive and not receiving hormonal replacement therapy, Exclusion Criteria: performing any regular physical exercise more than once a week over the 6 months preceding the beginning of the study

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

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TG<br> | Other: Physical activity<br>* The suspension device was securely attached to a fixed beam. The suspension programme included an initial 10 min warm-up with very low-intensity joint mobility exercises. The central part of the program had a duration of 40 min and included six exercises in which the level of intensity was based on the inclination of the body. The exercises were performed in a split routine, alternating by segment to prevent joint overload. Finally, participants performed 10 minutes of stretching.<br>|
| No Intervention: CG<br>the CG maintained their normal physical activity habits over the study | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase angle | Bioelectrical impedance parameter | 12 weeks | 
| Body composition | anthropometric measures | 12 weeks | 
| Handgrip strength | strength | 12 weeks |
Acetylic Salicylic Acid for the Treatment of Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
The pathomechanisms of COPD are still not fully understood, and up to now there is no satisfying causal treatment inhibiting the progress of the disease. Available therapy is in most cases symptomatic. Experimental and clinical observations suggest that treatment with ASA might be beneficial in the treatment of COPD in terms of respiratory and lung-functional improvement. To evaluate the efficacy of ASA as add-on therapy in COPD in comparison to placebo a prospective, randomized, double-blind, placebo controlled study will be conducted. Adult male and female patients (n=74) with proven COPD GOLD grade II-III will be randomized to 2 groups (i.e. 37 patients per group, stratification according to smoking status and gender). They will receive either 500 mg ASA per day or matching placebo over 12 weeks. Primary efficacy endpoints are changes in the lung-functional parameter FEV1 (forced expiratory 1-second volume) after 12 weeks of treatment. Secondary endpoints are the health score of the St. Georges respiratory questionnaire (SGRQ) and Peak-flow (PEF).

Official Title
-----------------
Acetylic Salicylic Acid for the Treatment of Chronic Obstructive Pulmonary Disease (COPD). A Randomized, Double-blind, Placebo-controlled Trial

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

Intervention / Treatment
-----------------
* Drug: Acetylsalicylic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD GOLD II or III Exclusion Criteria: Long term NSAIDS, pregnancy et al.

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ASA<br> | Drug: Acetylsalicylic acid<br>* 500 mg /day<br>|
| Placebo Comparator: Placebo<br> | Drug: Acetylsalicylic acid<br>* 500 mg /day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FEV1 (forced expiratory volume in 1 second) after 12 weeks of treatment | lung functional testing | 12 weeks |
A Study of Lymphangiogenesis in Colorectal and Nasopharyngeal Cancer

Study Overview
=================
Brief Summary
-----------------
To determine the association between LVD and clinico-pathologic variables in archived colorectal cancer and Nasopharyngeal carcinoma specimens To determine the association between VEGF-C,-D expression with COX-2 expression and clinico-pathologic variables in colorectal cancer and Nasopharyngeal carcinoma To determine the effect of celecoxib on lymphangiogenesis in Nasopharyngeal carcinoma Lymphangiogenesis and factors modulating lymphangiogenesis are associated with clinico-pathological outcome in Nasopharyngeal carcinoma and colorectal cancer. Celecoxib down-regulates lymphangiogenesis Archival colorectal cancer and Nasopharyngeal carcinoma tumor specimens will be obtained from the Department of Pathology. To determine the effect of celecoxib on lymphangiogenesis in Nasopharyngeal carcinoma, the investigators intend to analyze archived specimens collected in a previously conducted study. Colorectal tumor and nodal specimens and Nasopharyngeal carcinoma primary will be examined for MVD, LVD and growth factor expression using established haematoxylin and eosin and immunohistochemical techniques. Quantification of LVD and MVD shall be performed by two pathologists blinded to clinico-pathological variables using standardised methods.

Official Title
-----------------
A Study of Lymphangiogenesis in Colorectal and Nasopharyngeal Cancer

Conditions
-----------------
Colorectal Cancer, Nasopharyngeal Cancer

Intervention / Treatment
-----------------
* Procedure: Tumor biopsies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients are eligible Patients 21 years or older Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Tumor biopsies<br> | Procedure: Tumor biopsies<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Pilot Study of Metabolic Syndromes and HIV Infections in Indian Tibetans

Study Overview
=================
Brief Summary
-----------------
Kaohsiung Medical University Chung-Ho Memorial Hospital will provide a long-term free medical service in Indian Tibetans since July 2010. The investigators plan to investigate metabolic syndromes and HIV infection in Indian Tibetan community. The investigators will survey the prevalence and risk factors by means of HIV quick test and questionnaires. Since there is lacking of prevalence survey for metabolic syndrome and HIV infection in Tibetan colony of India, the investigiators will carry out this survey under the support and assistance of Department of Health of Central Tibetan Government.

Conditions
-----------------
Metabolic Syndromes, HIV Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Tibetan colony of India Exclusion Criteria: non-Tibetan colony of India
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 |
| --- | --- | --- |
Studies of Biomarkers in Female Lower Urinary Tract Symptoms

Study Overview
=================
Brief Summary
-----------------
To determine the sensitivity and specificity of urinary NGF, PGE2, IL-6, EGF or combinations in diagnosing different urodynamic diagnoses.

Detailed Description
-----------------
Abstract Background/Purpose: Urodyamic study is an objective method to evaluate female patients with lower urinary tract symptoms (LUTS). However, this method includes place a urinary catheter, thus prevents it as a routine method to evaluate and follow up patients with LUTS. Therefore, it is necessary to find a simple and objective method to help in evaluating female patients with LUTS. Several kinds of biomarker had been reported in diagnosing patients with overactive bladder; however, the sensitivity remained poor. The aim of this study is to find a useful biomarker, biomarkers, or combinations, with the aid of urodynamic study, to objectively and precisely in evaluating the female patients with LUTS. Patients and Methods: We will perform a prospective study to recruit 300 female patients with LUTS at the outpatient clinic of Department of Obstetrics and Gynecology of National Taiwan University Hospital and Far Eastern Memorial Hospital. All patients will be asked to complete OABSS, UDI-6 & IIQ-7 questionnaires, voiding diary, 20-min pad test and urodynamic studies. Urinary nerve growth factor, prostaglandin E2, interleukin-6 and epidermal growth factor were also measured. Besides, we will also recruit 30 female patients without LUTS in our outpatient clinic, and they will be asked to complete the above questionnaire and examinations except pad test and urodynamic studies. Possible Results: With the comparison of the above parameters between non-LUTS and LUTS patients, we can answer the questions that (1) the mean values of urinary NGF, PGE2, IL-6, EGF in different urodynamic studies, (2) the sensitivity and specificity of urinary NGF, PGE2, IL-6, EGF or combinations in diagnosing different urodynamic diagnoses.

Official Title
-----------------
Studies of Biomarkers in Different Urodynamic Diagnoses of Female Patients With Lower Urinary Tract Symptoms

Conditions
-----------------
Disorder of the Lower Urinary Tract

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients with lower urinary tract symptoms Exclusion Criteria: acute cystitis

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

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

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
-----------------
lower urinary tract symptoms, biomarkers, urodynamic studies
Development and Clinical Validation of Ketogen-based Therapeutic Diet for Pancreaticobiliary Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Decreased bowel function and loss of appetite in patients who underwent pancreaticobiliary surgery contribute impaired nutritional status in postoperative period. It can also affect perioperative and oncologic outcomes negatively. Therefore it is important to improve nutritional status in postoperative period by supply tailor-made optimal diets. The investigators have developed customized postoperative diets for pancreaticobiliary cancer patients. The investigators expect that customized diets for pancreaticobiliary patients will increase the food intake rate and contribute a improvement of perioperative outcomes and even oncologic outcomes.

Conditions
-----------------
Ketogen-based Therapeutic Diet, Pancreaticobiliary Cancer

Intervention / Treatment
-----------------
* Dietary Supplement: Ordinary Diet
* Dietary Supplement: Modified Atkin's Diet
* Dietary Supplement: Ketogenic Diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (age more than 19) Pancreaticobiliary cancer patient who is scheduled pancreaticoduodenectomy or distal pancreatectomy Pancreatic cancer / Duodenal cancer / Distal bile duct cancer / Ampulla of Vater cancer Exclusion Criteria: Patient who denied clinical trial Diabetes Mellitus(DM) patient with DM complication Hyperlipidemia patient with vascular co-morbidity Impaired renal function or renal failure (GFP<90%)

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ordinary Diet<br>Ordinary Diet | Dietary Supplement: Ordinary Diet<br> <br> |
| Other: Modified Atkin's Diet<br>Modified Atkin's Diet | Dietary Supplement: Modified Atkin's Diet<br> <br> |
| Other: Ketogenic Diet<br>Ketogenic Diet | Dietary Supplement: Ketogenic Diet<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food Intake Rate(%) for postoperative diet | Diet Intake Rate(%) will be examined by dietary satisfaction questionnaires. | 3 days after the diet |
A Randomized, Double-blind Study of the Effects of Fenretinide Administered in Subjects With Obesity

Study Overview
=================
Brief Summary
-----------------
Many metabolic complications of obesity are a consequence of abnormal responses of the liver, muscle, and fat to insulin actions. Fenretinide may improve the effects of insulin, preventing metabolic complications.

Official Title
-----------------
Phase 2 Study of the Assessment of the Insulin Sensitizing Activity of Fenretinide in Subjects With Insulin Resistance With BMI >30Kg/m2, and Liver Inflammation Related to Non-alcoholic Fatty Liver

Conditions
-----------------
Obesity, Insulin Resistance

Intervention / Treatment
-----------------
* Drug: Fenretinide
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI >30 Exclusion Criteria: Diabetes Requiring Medication Poorly Controlled Co-Morbidities

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Subjects in this cohort will be given Fenretinide | Drug: Fenretinide<br>* 200 mg/day<br>|
| Placebo Comparator: B<br>Subjects in this cohort will be given placebo. | Drug: Placebo<br>* 2 capsules/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the Effect on Insulin Resistance | This study was terminated due to expired drug with possibility of re-starting in the future. For this reason the randomization code has not been broken and the data has not been analyzed and there is no way to report the outcome measures. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the Biochemical Response in Cholesterol, Glucose and Related Blood Tests. | This study was terminated due to expired drug with possibility of re-starting in the future. For this reason the randomization code has not been broken and the data has not been analyzed and there is no way to report the outcome measures. | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, insulin resistance