linjc16/ctgov huggingface dataset:
Peer Interactions and Food Are Substitutable in Youth

Study Overview
=================
Brief Summary
-----------------
This study examines the effects of increasing the cost of social interactions and food on overweight and non-overweight youth. Using a computerized operant task youth will earn points exchangeable for food and social activity. The investigators predict that both overweight and non-overweight children will substitute food for interactions with an unfamiliar peer when this alternative is made expensive. Also, the investigators predict that both overweight and lean participants will defend their choice to spend time with a friend even when this alternative is made expensive.

Official Title
-----------------
Peer Interactions and Food Are Substitutable in Youth

Conditions
-----------------
Activity Choices, Caloric Intake, Social Time

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Boys and girls ages 9-11 Children must have a BMI equal to or greater than 15th percentile for their age Children must report at least a moderate liking of the study foods Exclusion Criteria: Children should not have any food allergies Children should not have any dietary restraint Children should not a cold or upper respiratory distress Children should not have any psychopathology Children should not have any developmental disabilities Children should not be taking any medications that could influence their sense of smell and taste and activity level

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 11 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 |
| --- | --- | --- |
| Caloric Intake |  |  | 
| Social Time |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Food reinforcement, social reinforcers, overweight, children
Impact of GH Measurements on GHD Diagnosis

Study Overview
=================
Brief Summary
-----------------
Human growth hormone (hGH) provocation test is an essential tool to assess growth hormone deficiency in children and young adults. It is important to have a robust and reliable method to determine the hGH peak of stimulation. This work aimed to compare three common automated immunoassays for hGH measurements and to assess whether there are still result-related differences influencing clinical decision.

Detailed Description
-----------------
The investigators analysed GH provocative test of 41 young patients (median age: 12 years) from Pediatric Department of Montpellier Hospital, (26 boys and 15 girls), admitted for follow-up or for suspicion of growth hormone deficiency. Serum GH of peak concentrations were compared using three automated immunoanalyses : COBAS 8000 e602 (ROCHE Diagnostics), IDS-iSYS (IDS immunodiagnostic systems) and Liaison XL (Diasorin S.A.).

Official Title
-----------------
Comparative Study of Human Growth Hormone Measurements: Impact on Clinical Interpretation

Conditions
-----------------
Growth Hormone Deficiency

Intervention / Treatment
-----------------
* Other: GH provocation tst


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age<18 years, admitted for suspicion (short stature or growth retardation) or follow-up of GHD in pre-and pubertal age patients undergoing insulin-induced hypoglycaemia stimulation test also called insulin tolerance test (ITT) Exclusion criteria: Age > 18 years Patients undergoing different provocation tests

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 15 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: GH provocation tst|All patients underwent insulin-induced hypoglycaemia stimulation test also called insulin tolerance test (ITT), considered the 'gold standard' test for GHD diagnosis. Following insulin administration by venipuncture (1UI/mL), levels of hGH and glucose were monitored on serum and fluoride tube plasma, respectively, at intervals of 0, 30, 45, 60 and 90 minutes (T0, T30, T45, T60 and T90).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparative study of human growth hormone measurements | Comparative study of human growth hormone measurements by using three different automated immunoassays | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stratification of patients based on GH peak secretion | Stratification of patients based on GH peak secretion | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
growth hormone deficiency, immunoanalysis, hGH provocation test, diagnosis
Study of Neurologic Progression With Motexafin Gadolinium and Radiation Therapy (SMART)

Study Overview
=================
Brief Summary
-----------------
The primary purpose of the study is to determine if patients with brain metastases from non-small cell lung cancer treated with Motexafin Gadolinium and whole brain radiation therapy retain their neurologic function and ability to think for a longer time compared to patients treated with whole brain radiation therapy alone.

Official Title
-----------------
Randomized Phase III Trial of Xcytrin® (Motexafin Gadolinium) Injection for the Treatment of Brain Metastases in Patients With Non-Small Cell Lung Cancer Undergoing Whole Brain Radiation Therapy

Conditions
-----------------
Metastases, Neoplasm, Brain Neoplasms, Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
-----------------
* Drug: Motexafin Gadolinium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (≥18 years old) with radiologically proven parenchymal brain metastases from histologically confirmed non-small cell lung cancer; KPS score of ≥70; Each patient must sign a study-specific Informed Consent form Exclusion Criteria: Liver metastases; Extracranial metastases in two or more organs; Known leptomeningeal metastases or subarachnoid spread of tumor; Prior whole brain radiation; Plan to use radiosurgery or radiation boost after completion of WBRT; Planned chemotherapy during study treatment (prior and subsequent chemotherapy is allowed); Prior total resection of a single brain metastasis; Laboratory values as follows: LDH > 1.3 x upper limit of normal (ULN); ANC < 1500 /mm³; Platelets < 50,000 /mm³; Creatinine > 2.0 mg/dL; AST or ALT > 2 x ULN; Total bilirubin > 2 x ULN; Women who are pregnant or lactating

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Motexafin Gadolinium|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
-----------------
Brain Neoplasms/radiotherapy, Neoplasms/complications/prevention & control,, Neuropsychological Tests,, Metalloporphyrins/therapeutic use,, Combined Modality Therapy,, Drug therapy,, Quality of Life,, Cranial Irradiation,, Radiotherapy/Targeted,, Prospective Studies,, Neoplasm Recurrence/Local,, Treatment Outcome, Brain metastases, Brain Neoplasms/secondary, Non-small cell lung cancer
Breast Cancer 2-PREVENT Translational Center of Excellence (TCE) - Metastatic Markers of Recurrent Tumor Phenotype for Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This is a cohort study of women with suspected or confirmed recurrent breast cancer, with accessible tumor by standard clinical biopsy, prior to starting a new therapy for recurrent metastatic disease. Study participants will be ascertained from the population of all persons greater than eighteen years of age receiving care at the clinical practices of the Rowan Breast Center (RBC) at the University of Pennsylvania. The overarching goal of this study is to identify the genetic and molecular markers of molecular evolution identified in patients who have progressed from a primary diagnosis of breast cancer to recurrent, metastatic disease. As an observational study, this study seeks to gather data regarding the molecular and genetic changes that a primary cancer undergoes as a patient's cancer recurs and ultimately progresses. We anticipate enrolling 600 women with recurrent breast cancer who meet eligibility requirements for this study. Participation in this study will include the following: a biopsy and blood collection, completion of the study questionnaire, an optional bone marrow aspiration, and repeat collection of blood, offer of a research biopsy and a optional bone marrow aspirate collection at each progression time point. The study participants' medical information will be updated and changes in disease status will be captured on a regular basis.

Official Title
-----------------
Breast Cancer 2-PREVENT Translational Center of Excellence (TCE) - Metastatic Markers of Recurrent Tumor Phenotype for Breast Cancer

Conditions
-----------------
Women With Suspected or Confirmed Recurrent Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically-confirmed breast cancer - based upon pathology report of the primary or metastatic diagnosis Recurrent breast cancer (local, regional, or distant disease) - as determined by either clinical,radiological, or pathological evaluation Willing to undergo or provide tissue from a recent biopsy of recurrent tumor for both clinical and research testing Willing to undergo blood specimen collection Age 18 or over and are able to give informed consent Exclusion Criteria: Non-metastatic breast cancer (stage I, II or III) Anticoagulation that cannot be interrupted for the purpose of study evaluation (patients must have normal INR and PTT at the time of study biopsy)

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 |
| --- | --- | --- |
| subjects with detectable DTCs/CTCs |  | 2 years |
Writing About Disease: Effect on Rehabilitation?

Study Overview
=================
Brief Summary
-----------------
Therapeutic writing about one's emotions has been described previously (J Pennebaker: Emotions, disclosure and health. Am Psychol. Assoc 1995). The present project will compare the effects (if any) of writing about the emotional versus the physical consequences of lung disease on anxiety, perceived quality of life, and perceived health status.

Detailed Description
-----------------
Chronic obstructive pulmonary disease (COPD) patients (age 35-70) and asthma patients (age 20-60) referred to a 4 weeks inpatient rehabilitation program - who agree to participate in the project - are randomly assigned to one of three conditions: Writing about emotional consequences of their disease before the program starts Writing about physical consequences of their disease before the program starts Not writing All patients are measured (completing questionnaires at home) on: perceived quality of life, perceived health status and trait anxiety - 2 weeks before the program, 2 weeks after the program and 6 months after the program. FEV1 and 6 min walking distance are measured at the beginning and by the end of the program. In addition to questionnaires, all patients are asked to: Write in their own words ( 2 weeks after) to evaluate their stay at the rehabilitation clinic; and Write in their own words (6 months after) about how the disease affects their life at that point. Both quantitative and qualitative data will be used for analysis purposes.

Official Title
-----------------
Writing About Disease: Effect on Rehabilitation?

Conditions
-----------------
COPD, Asthma

Intervention / Treatment
-----------------
* Procedure: writing about disease


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of COPD (age between 35 and 70) Clinical diagnosis of asthma (age between 20 and 60)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: writing about disease|writing about physical or emotional consequences of pulmonary disease|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | prospective | 
| Perceived health status |  | prospective | 
| Trait anxiety |  | prospective | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced expiratory volume in 1 second (FEV1) |  | prospective | 
| 6-minute walking distance |  | prospective | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
copd, asthma, QoL, Perceived health status, Trait anxiety
Dynamic Changes of Gut Microbiota in UC After FMT

Study Overview
=================
Brief Summary
-----------------
A prospective study to investigate the dynamic changes of gut microbiota through colonic transendoscopic enteral tubing in patients with ulcerative colitis after fecal microbiota transplantation.

Detailed Description
-----------------
Colonic transendoscopic enteral tubing (TET) is a novel, safe, convenient, and reliable way for fecal microbiota transplantation (FMT) and the whole-colon enema treatment. This tube also can serve as a medium for collecting gut microbiota. Fecal Microbiota Transplantation (FMT) was identified to be promising for ulcerative colitis (UC). This study aims to investigate the dynamic changes of gut microbiota in patients with UC after FMT.

Official Title
-----------------
Dynamic Changes of Gut Microbiota in Patients With Ulcerative Colitis After Fecal Transplantation

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Device: colonic transendoscopic enteral tubing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients were diagnosed with mild or moderate ulcerative colitis. Patients need colonic TET and FMT Must be able to colonic TET and no contraindication by endoscopic examination, consent colon TET implantation and not associated with severe intestinal lesions such as fistula, stenosis, complex perianal lesions, severe ileocecal or ascending colon lesions resulting in no proper site for titanium clip fixation. Age > 7 years old and < 65 years old Exclusion Criteria: gut microbiota was not collected successfully

Ages Eligible for Study
-----------------
Minimum Age: 7 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: colonic TET and FMT<br>gut microbiota will be collected through the colonic TET after FMT | Device: colonic transendoscopic enteral tubing<br>* Colonic transendoscopic enteral tubing (TET) is a novel, safe, convenient, and reliable way for fecal microbiota transplantation (FMT) and the whole-colon enema treatment.<br>* Other names: fecal microbiota transplantation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of gut microbiota | gut microbiota will be collected through the colonic TET | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of defecation | the frequency of defecation in UC patients will be recorded | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transendoscopic enteral tubing, gut microbiota, ulcerative colitis
Use of Febuxostat in Hyperuricemia Among Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
Hyperuricemia is not infrequently encountered among hemodialysis patients. However, there is no clear data about use of febuxostat among hemodialysis patients, apart from very small case series. The aim of this study is to investigate the efficacy of using febuxostat for the treatment of Hyperuricemia among hemodialysis patients.

Official Title
-----------------
Use of Febuxostat in Hyperuricemia Among Hemodialysis Patients

Conditions
-----------------
Hyperuricemia, Hemodialysis Complication

Intervention / Treatment
-----------------
* Drug: Febuxostat 40 milligramsTablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age above 18 years Hemodialysis patient Hyperuricemia (Uric acid level above 6.0 mg/dL in females and 7.0 mg/dL in males) Exclusion Criteria: Patient currently and/or recently received drugs for hyperuricemia within the last three months Patient had recent (within 3 months) change of erythropoiesis stimulating drugs or other drug known to increase uric acid e.g furosemide

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

| Intervention/Treatment |
| --- |
|Drug: Febuxostat 40 milligramsTablet|Febuxostat 40 milligramsTablet every other day for 3 months|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum uric acid | Change in serum uric acid after 3 months of Febuxostat 40 milligrams Tablet therapy | at three months of Febuxostat 40 milligrams Tablet therapy |
Genomic Endometrial Expression in Obesity

Study Overview
=================
Brief Summary
-----------------
Determine if different genomic endometrial expression exists during embryo implantation in obese women in comparison with non obese women.

Conditions
-----------------
Obesity and Embryo Implantation

Intervention / Treatment
-----------------
* Procedure: endometrial biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: group A: non obese oocyte donors (BMI: 18 - 29 kg. /m2)with proven fertility group B: obese oocyte donors: (BMI: >29 kg./m2)with proven fertility group C: obese (BMI: >29 kg./m2) infertile patients, Exclusion Criteria: recurrent miscarriage

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: endometrial biopsy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Evaluate the Safety and Efficacy of Bremelanotide in Women With Female Sexual Arousal Disorder (FSAD)

Study Overview
=================
Brief Summary
-----------------
This 8 week at home study is designed to explore efficacy endpoints and evaluate the safety of intranasal Bremelanotide in women with Female Sexual Arousal Disorder. Efficacy will be assessed vs. a parallel placebo group.

Conditions
-----------------
Sexual Arousal Disorder

Intervention / Treatment
-----------------
* Drug: Bremelanotide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post menopausal and in general good health In a stable relationship with a male partner for at least 6 months Willing to attempt sexual activity once a week with your partner

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 70 Years

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bremelanotide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Exploratory Study to Investigate the Reparative and Regenerative Potential of Alemtuzumab in Relapsing-Remitting Multiple Sclerosis Patients Participating in the CARE MS I and MS II Studies

Study Overview
=================
Brief Summary
-----------------
The primary goal of this study will be to explore the reparative and regenerative potential of alemtuzumab in RRMS patients who are participating in the CARE MS I and CARE MS II studies using conventional and non-conventional MRI sequences.

Official Title
-----------------
An Exploratory Study to Investigate the Reparative and Regenerative Potential of Alemtuzumab in Relapsing-Remitting Multiple Sclerosis: A Multi-Parametric Non-Conventional MRI Sub-Study in Patient Participating in the CARE MS I and CARE MS II Studies

Conditions
-----------------
Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participating in either the CARE MS I or CARE MS II studies Exclusion Criteria: Not a participant in the CARE MS I or CARE MS II studies

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Alemtuzumab Group<br> | |
| Interferon Beta-1a SC Group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Explore the reparative and regenerative potential of alemtuzumab in RRMS patients who are participating in the CARE MS I and CARE MS II studies |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the effect of alemtuzumab to interferon beta-1a SC on non-conventional MRI outcomes |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients with RRMS who are participating in the CARE MS I and CARE MS II