linjc16/ctgov huggingface dataset:
Minimally Invasive Surgery of the Gastro-esophageal Junction

Study Overview
=================
Brief Summary
-----------------
This study will assess short and long term outcomes of individuals undergoing minimally invasive surgery of the gastro-esophageal junction (MISGEJ). Patients will respond to questionnaires on an annual basis evaluating quality of life and functionality following MISGEJ. Hospital charts will also be reviewed on an annual basis to assess patient health outcomes.

Official Title
-----------------
Functional Assessment Following Minimally Invasive Surgery of the Gastro-Esophageal Junction

Conditions
-----------------
Achalasia, Paraesophageal Hernia, GERD, Epiphrenic Diverticula, Zenker's Diverticulum

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients at the Ottawa Hospital undergoing minimally invasive surgery of the GEJ Exclusion Criteria: Less than 18 years of age.

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 |
| --- | --- | --- |
| MISGEJ symptoms (subjective) | MISGEJ symptom questionnaire evaluated on an annual basis | 8 years | 
| Achalasia Disease Severity (subjective) | Achalasia Disease Severity questionnaire evaluated on an annual basis. | 8 years | 
| Diagnostic imaging | Patient x-rays, upper GI tests, Endoscopy, and/or CT scans will be assessed on an annual basis to objectively measure functionality and health status. | 8 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastro-esophageal junction, minimally invasive, Achalasia, Paraesophageal hernia, GERD, Epiphrenic diverticula, Zenker's diverticulum, All minimally invasive surgeries of the gastro-esophageal junction
Parental Mental Health After Tracheostomy in Early Childhood

Study Overview
=================
Brief Summary
-----------------
To assess the prevalence of anxiety / depression in post- hospital for parents (mothers and fathers) of children with tracheotomy before the age of 1 year between 2000 and 2012.

Detailed Description
-----------------
The goal of this study is to evaluate the level of anxiety / depression of families and to correlate to the lived parental of tracheotomy and indirectly that of the child (hetero - evaluation). The information from this study should allow staff to refine and adjust their practices in terms of information and support for families with tracheotomised children. The information given to families before the establishment of a tracheotomy for their child may also be adapted.

Official Title
-----------------
Post-hospital Evaluation of Anxiety / Depression in Parents of Children Who Required Tracheostomy Before the Age of 1 Year

Conditions
-----------------
Tracheotomised Children, Anxiety of Parents, Depression of Parents

Intervention / Treatment
-----------------
* Other: Auto-Questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria : Families whose child : Has been tracheotomised before the age of 1 year between 2000 and 2012 Came out of hospital with a tracheotomy tube Is or has been followed by one of three centers Exclusion criteria : Children decannulated before hospital discharge . Death before the start of the study
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Auto-Questionnaires|Consents and questionnaires will be sent to the parental home or filled in an interview with an investigator (or telephone consultation).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety and Depression | Auto-questionnaire Hospital Anxiety and Depression Scale HADS | Through study completion, up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Experienced of the care by the families | Auto-questionnaire Hartnick | Through study completion, up to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tracheotomy, Anxiety, Depression, Back Home
Storage and Research Use of Human Bio-specimens From Melanoma Patients and Clinical Testing for Assignment of Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to identify biological characteristics occurring in the initiation and progression of melanoma.

Conditions
-----------------
Melanoma

Intervention / Treatment
-----------------
* Other: Tissue and blood collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Pathologically-proven diagnosis of melanoma. Patient must have a test or procedure that has the potential to provide left-over tissue that can be banked for future research purposes OR the patient has already had a diagnostic or therapeutic procedure but who has not yet been approached to participate is also eligible. Exclusion criteria Any patient with significant contraindications to venipuncture (e.g., severe anemia) will be excluded from blood collection procedures. However, if the patient provides consent and a paraffin-embedded block or 10-15 unstained slides of their tissue diagnosis, they will not be excluded from this protocol. Any patient unable or unwilling to provide consent.

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 |
| --- |
|Other: Tissue and blood collection|Tissue will be obtained from a previous biopsy if available, or if unavailable, tissue will be collected from a scheduled biopsy. About3-4 teaspoons of blood will be collected.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Molecular changes in patients' melanoma tissue | Tissue is collected upon consent or upon receipt of parafin block, primary aim will be met when all tissues are collected and analyzed at conclusion of study. Intent is to aid patients and their treating physician when making treatment decisions. | at 120 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improve the time between ordering the test and results entry into medical records | To enhance the speed and detail of molecular mutation profiling of melanoma | 120 months |
Prenatal Test for Fetal Aneuploidy Detection

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop and evaluate a blood test for pregnant women for detection of fetal aneuploidy.

Official Title
-----------------
Investigational Study of a Prenatal Diagnostic Test for Fetal Aneuploidy

Conditions
-----------------
Aneuploidy, Trisomy 21

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is 18yrs or older Subject has a singleton pregnancy Subject is planning to undergo chorionic villus sampling (CVS) and/or amniocentesis with current pregnancy Subject is able to provide consent Exclusion Criteria: Subject is pregnant with more than one fetus Subject (mother) has known aneuploidy Subject has active malignancy requiring major surgery or systemic chemotherapy or has a history of metastatic cancer. Subject has already undergone CVS or amniocentesis during current pregnancy prior to study enrollment.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Positive for fetal aneuploidy<br> | |
| Negative for fetal aneuploidy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of blood test to results from chorionic villus sampling or amniocentesis for fetal aneuploidy detection | Circulating genomic material from maternal blood will be quantified using biochemical techniques to determine the presence of fetal aneuploidy. The results obtained from analysis of circulating genomic material will be compared to the karyotype results from chorionic villus sampling or amniocentesis. | 24 months |
Examining B12 Deficiency Associated With C677T Mutation on MTHFR Gene in Terms of Commonness and Endothelial Function

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the commonness of the C677T mutation in the MTHFR gene in subjects with B12 deficiency. Also, we'd like to investigate the effect of B12 deficiency combined with the C677T mutation on endothelial function.

Detailed Description
-----------------
we showed that patiebts with B12 deficiency have higher than expected frequency of MTHFR mutation and patients with both abnormalities havean abnormal endothelial function

Official Title
-----------------
Examining the Commonness of the C677T Mutation in the MTHFR Gene in Subjects With B12 Deficiency and the Influence of the B12 Deficiency Combined With the C677T Mutation on the MTHFR Gene on Endothelial Function.

Conditions
-----------------
B12 Deficiency Combined With C677T Mutation on MTHFR Gene

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin B12 + Folic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult males and females of the broad population aged 20-60 with no symptomatic heart disease/condition with Vitamin B12 levels of 150 pmol or less which have not received Vitamin B12 supplement treatment before Exclusion Criteria: Adults suffering from a known heart disease/condition any disease the investigator might find as interfering with the process of the experiment tumor-oriented diseases

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: B<br>The control group, marked B, gets only B12 vitamin 1mg/day treatment to comply with ethics regulations seeing as they do suffer from B12 deficiency . | |
| Experimental: A<br>The trial group which receives daily treatment of 1mg Vitamin B12 (sublingual tablets) combined with 5 mg Folic acid (tablets) | Dietary Supplement: Vitamin B12 + Folic Acid<br>* Trial group would get daily treatment of 1 mg Vitamin B12 combined with 5 mg Folic Acid<br>* Other names: Folic acid, 5 mg, by Rakah;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary measure to determine the effect of the treatment will be reduced levels of Homocysteine in subjects with B12 deficiency combined with C677T mutation in the MTHFR gene. |  | The key measure would be measured upon enrollment and 6 weeks afterwards, upon completion of treatment based on 1mg Vitamin B12 sublinual and 5 mg Folic Acid per day. |
Reduction of the Dietary Glycemic Index (GI) by L-Arabinose and Indigestible Dextrin

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate the effect of supplement containing L-arabinose and indigestible dextrin on dietary glycemic index.

Official Title
-----------------
Effects of the Combination of L-Arabinose and Indigestible Dextrin on Glycemic Index: a Double-Blind, Crossover Trial

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

Intervention / Treatment
-----------------
* Dietary Supplement: L-arabinose and indigestible dextrin
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy as based on medical history and physical examination BMI is less or equal to 30 kg/m2 Willing not to serve as blood donor during the study Informed consent signed Exclusion Criteria: Impaired Glucose Tolerance Female subjects who are pregnant or nursing a child Participation in any clinical trial up to 90 days before Day 1 of this study Renal or hepatic dysfunction Heart disease Under medication

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oolong tea containing L-arabinose and indigestible dextrin<br> | Dietary Supplement: L-arabinose and indigestible dextrin<br> <br> |
| Placebo Comparator: Oolong tea<br> | Dietary Supplement: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial glucose level |  | 2 hours |
The Detection of Circulating Tumor Cells (CTCs) in Breast Cancer With a Novel in Vivo Device

Study Overview
=================
Brief Summary
-----------------
The GILUPI CellCollector® is the first in vivo CTC isolation product worldwide which is CE approved. Application data of CellCollector in China is not available now. The purpose of this clinical trial is to confirm the validation and safety of CellCollector in Chinese patients.

Conditions
-----------------
Circulating Tumor Cells.Breast

Intervention / Treatment
-----------------
* Device: Circulating tumor cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Metastasis breast cancer confirmed with imaging examination Have agreed to undergo CTC analysis in vivo; ECOG：0-2 Exclusion Criteria: Non-metastasis breast cancer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Experimental: MBC Group<br>metastatic breast cancer Age：18-75 ECOG:0-2 | Device: Circulating tumor cells<br> <br> |
| Experimental: Control Group<br>benign breast tumour Age：18-75 ECOG:0-2 | Device: Circulating tumor cells<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of CellCollector | CTC enumeration and detection rate in Chinese patients with metastasis breast cancer will be analyzed by using CellCollector. | 6 month | 
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Number of participants with treatment-related adverse events and blood IgE level will be analyzed after CellCollector application. | 6 month |
Multiple Ascending Dose Study of BMS-907351 (XL184) in Patients With Solid Tumors in Japan

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical study is to establish the maximum tolerated dose (MTD) and recommended Phase 2 dose (or dose range as appropriate) of BMS-907351 (XL184) when administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors.

Official Title
-----------------
Phase 1 Multiple Ascending Dose Study of BMS-907351 (XL184) Monotherapy in Japanese Subjects With Advanced or Metastatic Solid Tumors

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Drug: BMS-907351 (XL184)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced or metastatic solid tumors for whom the standard of care is ineffective or inappropriate Life expectancy of at least 3 months Eastern Cooperative Oncology Group performance 0-2 Exclusion Criteria: Subject has uncontrolled intercurrent illness

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-907351 (XL184)<br> | Drug: BMS-907351 (XL184)<br>* Capsules, Oral, 25, 50, 75, 100, 125 and 175 mg, Once daily, Until disease progression or unacceptable toxicity became apparent<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish the MTD and recommended Phase 2 dose (or dose range as appropriate) of BMS-907351 (XL184) when administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors |  | Within the first 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of multiple doses of BMS-907351 (XL184) administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors |  | Day 1, 2, 5, 8, 15, 19, 20, 29 and every 2 weeks thereafter | 
| To assess plasma pharmacokinetics (PK) of oral administration of BMS-907351 (XL184) and the metabolite(s) in subjects with advanced or metastatic solid tumors |  | Day 1, 5, 15, 19 and 29 | 
| To assess tumor response (preliminary anti-tumor activity) after repeated administration of BMS-907351 (XL184) |  | Every 8 weeks | 
| To assess the pharmacodynamic correlates of BMS-907351 (XL184) activity |  | Day 1, 5, 15, 19, 29 and every 4 weeks thereafter |
Motion Syros: A Randomized Study Investigating the Efficacy of Tradipitant in Treating Motion Sickness

Study Overview
=================
Brief Summary
-----------------
A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy of tradipitant in the treatment of motion sickness.

Official Title
-----------------
Motion Syros: A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Tradipitant in the Treatment of Motion Sickness

Conditions
-----------------
Motion Sickness

Intervention / Treatment
-----------------
* Drug: Tradipitant High Dose
* Drug: Tradipitant Low Dose
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of motion sickness Age 18-75 Exclusion Criteria: Nausea-inducing disorder other than motion sickness BMI>40 History of intolerance and/or hypersensitivity to Neurokinin-1 Receptor antagonists

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tradipitant High Dose<br> | Drug: Tradipitant High Dose<br>* Oral Capsule<br>|
| Experimental: Tradipitant Low Dose<br> | Drug: Tradipitant Low Dose<br>* Oral Capsule<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Oral Capsule<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in the incidence of vomiting as measured by the MSSS | Reduction in the incidence of vomiting as measured by the MSSS; Motion Sickness Severity Scale (MSSS) is a NRS (0-6); lower score indicates improvement | 1 day |
Behavior and Naltrexone Treatment for Alcoholics

Study Overview
=================
Brief Summary
-----------------
The study's purpose is to improve alcoholism treatment by investigating the combined effectiveness of a psychotherapy (Coping Skills Training and Cue Exposure Treatment - CSTCET) with naltrexone in a randomized clinical trial. Individuals will receive 2 weeks of CSTCET or a control treatment as inpatients followed by 12 consecutive weeks of receiving either naltrexone or placebo as outpatients. Followups at 24, 48, and 72 weeks after treatment is completed.

Official Title
-----------------
Coping, Exposure, and Naltrexone Treatment With Alcoholics

Conditions
-----------------
Alcoholism

Intervention / Treatment
-----------------
* Drug: naltrexone (Revia)
* Behavioral: cognitive behavioral therapy
* Behavioral: cue exposure treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meets criteria for alcohol dependence. Exclusion Criteria: Current diagnosis of dependence on other substances except nicotine. A history of psychosis or current psychotic symptoms. Current suicidality, homocidality, or psychiatric symptoms that require additional medication. Current use of disulfiram (Antabuse). Evidence of significant cerebral, renal, thyroid, or cardiac disease. History of opioid abuse in the previous year. History of cirrhosis, hepatocellular disease, or elevated bilirubin. Females who are pregnant, nursing, or not using a reliable method of birth control.

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: Factorial Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: naltrexone (Revia)|nan|
|Behavioral: cognitive behavioral therapy|nan|
|Behavioral: cue exposure treatment|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |