linjc16/ctgov huggingface dataset:
Randomized Phase II Study of SOL for Untreated Metastatic Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
This is a randomized, multicenter study designed to evaluate the progression free survival of the SOL group (S-1, Leucovorin, and Oxaliplatin) compared with the mFOLFOX6 group (5-FU, l-LV and Oxaliplatin) as first-line treatment of patients with metastatic colorectal cancer.

Official Title
-----------------
Randomized Phase II Study of S-1, Oral Leucovorin, and Oxaliplatin Combination Therapy (SOL) Versus 5-FU, l-LV and Oxaliplatin Combination Therapy (mFOLFOX6) in Patients With Untreated Metastatic Colorectal Cancer

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin)
* Drug: mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proved adenocarcinoma (colorectal cancer). Age: 20 ≤ at enrollment. No prior treatment (ex. radiation therapy, chemotherapy, hormonal therapy) to advanced disease. Patients who received adjuvant chemotherapy more than 180 days before enrollment can be allowed but those who received S-1 or Oxaliplatin containing treatment shall be excluded. At least one measurable lesion by RECIST criteria Exclusion Criteria: Serious drug hypersensitivity. Prior history of peripheral neuropathy. Diarrhea . Simultaneously active double cancer.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin) | Drug: SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin)<br>* L-OHP 85 mg/m2 iv. for 2 hr on day 1 of each 2 weeks cycle S-1 40-60 mg bid day 1～day 7 LV 25 mg bid day 1～day 7<br>|
| Active Comparator: 2<br>mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin) | Drug: mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin)<br>* L-OHP 85 mg/m2 iv. for 2 hr on day 1 of each 2 weeks cycle l-LV 200 mg/m2 iv. for 2 hr on day 1 5-FU 400 mg/m2 bolus on day 1 5-FU 2400 mg/m2 ci for 46 hr (day 1, 2hr～48hr)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) |  | Until progression | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | During chemotherapy |
Functional Neuroimaging and Genetic Vulnerability to Suicidal Behavior

Study Overview
=================
Brief Summary
-----------------
The main objective is to highlight, by functional imaging (MRI) dysfunctional brain regions associated with vulnerability to suicidal behavior.

Conditions
-----------------
Suicidal Behavior

Intervention / Treatment
-----------------
* Device: Magnetic resonance imaging (MRI)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: right-handed arm suicidal : Personal history of unipolar depressive disorder or bipolar disorder and having realized in his life at least one suicide attempt arm emotional Witnesses : Personal history of unipolar depressive disorder or bipolar disorder and have never done in his life attempted suicide arm healthy Witnesses : any current or past personal history of psychiatric disorders of Axis I and have never done in his life attempted suicide Exclusion Criteria: Cons-indications to the use of MRI Existence of a past history of head trauma with loss of consciousness or neurological brain disorder or secondary neurological suffering suicidal gesture.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: healthy volunteers<br>subject with no current or past personal history of psychiatric disorders and about never having carried out suicide attempt | Device: Magnetic resonance imaging (MRI)<br> <br> |
| Other: emotional witness<br>subject having had a personal history of unipolar or bipolar depressive disorder and who have never done in his life attempted suicide | Device: Magnetic resonance imaging (MRI)<br> <br> |
| Other: patient suicide<br>subject having had a personal history of unipolar or bipolar depressive disorder and having realized in his life at least one suicide attempt | Device: Magnetic resonance imaging (MRI)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI variations | activation of specific brain areas during the procurement of a test decision | at day 0 |
Epidemiology, Management and Complications Related to Pancreatic Trauma in Children

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to better evaluate the treatment and development of children and adolescents who have had a pancreatic trauma and who are being followed in Belgian hospitals.

Detailed Description
-----------------
The aim of this study is to better evaluate the treatment and development of children and adolescents who have had a pancreatic trauma and who are being followed in Belgian hospitals. Through this study, the investigators hope to be able to understand: The epidemiology of pancreatic trauma in Belgium. How these traumas occur (accident, fall,...). Pancreatic trauma management in Belgian hospitals according to severity grade. Short- and medium-term complications associated with the trauma Long-term complications of trauma on growth and on the endocrine and exocrine function of the pancreas. On the basis of all the information collected, the investigators hope to be able to provide indicators on the epidemiology of pancreatic trauma in children, short-term risks as well as nutritional and functional risks, taking into account the initial management of the patient.

Official Title
-----------------
Retrospective and Prospective Study on the Epidemiology, Management and Complications Related to Pancreatic Trauma in Children

Conditions
-----------------
Pancreas Injury, Child, Only

Intervention / Treatment
-----------------
* Other: nutritional questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child aged ˂18 years at the time of the trauma Child regularly followed in paediatric gastroenterology consultation Positive history of pancreatic trauma Child with at least one blood lipase measurement Child with at least one pancreatic imaging available Exclusion Criteria: age >18 years

Ages Eligible for Study
-----------------
Maximum Age: 17 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pancreas injury<br>children with Pancreas trauma | Other: nutritional questionnaire<br>* nutritional questionnaire is given to the patient after the injury<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of pancreas injury in children | number of new diagnosis | from start of inclusion to 2 years thereafter | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pancreas Injury, Child
Autologous Fecal Therapy

Study Overview
=================
Brief Summary
-----------------
Ten healthy volunteers will be recruited to receive either an autologous stool transplant or a saline enema to determine if autologous fecal microbiota therapy will be able to rapidly, and safely, restore a patient's fecal microbiome after antimicrobial exposure.

Official Title
-----------------
Restoration of the Fecal Microbiome After Antimicrobial Exposure With Autologous Fecal Flora Restoration Therapy

Conditions
-----------------
Infectious Disease of Digestive Tract

Intervention / Treatment
-----------------
* Biological: Autologous fecal microbiota therapy
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Adults 18-70 years of age- Exclusion Criteria: history of allergic reaction to beta-lactam antimicrobials; any non-topical antimicrobial exposure or tube feeds as a primary source of nutrition in the past six months; pregnant or risk of becoming pregnant during the study period; gastroenteritis in the last 3 months; incontinent of stool; prior resection or alteration of the stomach; small bowel, or colon; unwillingness to receive an enema/FMT; known colonization with an MDRO; anticipated change in diet or medications, or elective surgery, during the study period; or a history of an intestinal disorder -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Auto fecal microbitoa therapy<br>autologous fecal microbiota therapy | Biological: Autologous fecal microbiota therapy<br> <br> |
| Placebo Comparator: Saline enema<br>Saline enema | Other: Placebo<br>* Saline enema<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Restoration of Microbial Community Composition to the Pre-antibiotic State by 90 Days Post FMT or Saline Enema | Restoration of microbial community composition (bacterial taxa that are present) and structure (abundance of taxa) to the subject's state prior to antimicrobial exposure. Bacterial taxa are the types/strains of bacteria found in the microbiome. | 90 days after enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fecal microbiota therapy
The Effect of PAP on ISSHL Comorbided With OSA

Study Overview
=================
Brief Summary
-----------------
This clinical randomized controlled study is to explore the effect of positive airway pressure(PAP) on patients in Beijing Tsinghua Changgung Hospital diagnosed with both idiopathic sudden sensorineural hearing loss comorbided(ISSHL) and obstructive sleep apnea(OSA) between Dec. 2019 to Dec. 2029.

Official Title
-----------------
The Effect of Positive Airway Pressure on Idiopathic Sudden Sensorineural Hearing Loss Comorbided With Obstructive Sleep Apnea: A Clinical Randomized Controlled Study

Conditions
-----------------
Sudden Hearing Loss, Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: non-invasive positive airway pressure
* Drug: Methylprednisolone Hemisuccinate
* Drug: Ginaton


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged >= 18 and <= 70, diagnosed with OSA by full-night in-lab or home-stay PSG according to AASM 2012 criteria, and AHI > 15/h, diagnosed with ISSHL by AAO-HNS 2019 criteria, ISSHL onset within 1 week. Exclusion Criteria: sudden hearing loss with certain causes, with severe comorbid diseases, pregnant or breast-feeding women, AHI <= 15/h, hearing threshold recovered > 50% when included, previously regularly treated with PAP.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PAP plus medication<br>patients treated by both PAP and medication | Device: non-invasive positive airway pressure<br>* non-invasive positive airway pressure is the first-line treatment for obstructive sleep apnea<br>Drug: Methylprednisolone Hemisuccinate<br>* Methylprednisolone is the first-line treatment of idiopathic sudden sensorineural hearing loss<br>* Other names: Methylprednisolone, MP;Drug: Ginaton<br>* ginnaton is ginkgo biloba extract<br>* Other names: Ginkgo biloba extract,GBE;|
| Active Comparator: medication<br>patients treated by medication only | Drug: Methylprednisolone Hemisuccinate<br>* Methylprednisolone is the first-line treatment of idiopathic sudden sensorineural hearing loss<br>* Other names: Methylprednisolone, MP;Drug: Ginaton<br>* ginnaton is ginkgo biloba extract<br>* Other names: Ginkgo biloba extract,GBE;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hearing threshold | the recovery of hearing threshold which will be measured by pure tone audiometry | 3 months after onset of ISSHL |
Microarray Analysis of Gene Expression in Prostate Tissues

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate gene expression profiles and biologic features of prostate tissue and how they relate to prostate cancer development and growth.

Official Title
-----------------
Microarray Analysis of Gene Expression in Prostate Tissues (Translating Prostate Cancer Gene Expression Sub-types)

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patient scheduled to undergo either a biopsy or surgery for a prostate condition. Exclusion Criteria: - Patients without a prostate condition

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

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

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 |
| --- | --- | --- |
| Correlate genotype with pathologic phenotype and clinical outcome. | The Tissue Bank will store all Tissue Bank consents. The patients will be given a unique identifier by the tissue bank. However, patients will need to be identified to link to clinical data and possible followup (if they have consented) via chart or tumor registries. | one time | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate cancer, Gene expression, tumor markers, microarray analysis
Follow up of Patients Treated With Cognitive Behavioural Therapy for Hypochondria From 1997 to 2007

Study Overview
=================
Brief Summary
-----------------
Research has shown that cognitive behavioural therapy is effective in treating hypochondria. However, no studies have examined the long term effect. The investigators have followed 56 patients treated for hypochondria between 1997 and 2001 and the investigators are now doing a 10 year follow-up (Part I). In another part of the study (Part II) the investigators compare the effect of 16 sessions vs. 5 sessions, with a follow-up period of at least 2 years. The investigators hypothesis is that the initial 1 year improvement will be sustained and that 5 sessions will yield the same results as 16 sessions.

Detailed Description
-----------------
The follow-up includes a telephone interview by independent researcher and the patients fill in the following questionnaires: Whiteley Index (measures health anxiety), VAS-scales for health anxiety, worrying about symptoms and body checking, SF-36 (health related quality of life), Giessen Subjective Complaints List, Spielberger Trait and State Anxiety Scale Beck Depression Inventory, Eysenck Personality Questionnaire, General Health Questionnaire (GHQ 28), Somatic Amplification Scale,

Official Title
-----------------
Follow up of Patients Treated With Cognitive Behavioural Therapy at Clinic for Hypochondriacs, Haraldsplass Deaconal Hospital, From 1997 to 2007

Conditions
-----------------
Hypochondriasis

Intervention / Treatment
-----------------
* Behavioral: Cognitive behavioural therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fulfilling ICD-10 criteria for hypochondriacal disorder Exclusion Criteria: Unwillingness to participate Substance abuse Serious psychological (f.inst. psychosis, major depression) or somatic (f.inst. cancer) disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychotherapy<br> | Behavioral: Cognitive behavioural therapy<br>* 16 sessions vs 5 sessions of cognitive behavioural therapy<br>* Other names: Cognitive therapy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of health anxiety |  | 10 years follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life |  | 10 years follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypochondria, Cognitive behavioural therapy, Long term follow-up, Psychosomatics, Psychotherapy
Changes in Leukotrienes During Cardiac Surgery in Patients With Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
The hypotheses of this study are that: Production and release of inflammatory substances called leukotrienes are increased during heart surgery with use of a heart-lung machine in humans; The increase in these leukotrienes levels after heart surgery is higher in patients with bronchitis and/or emphysema than in patients without previous history of lung disease; Levels of leukotrienes are directly correlated with worsening of lung function during and after heart surgery.

Detailed Description
-----------------
In this project, we will test the hypothesis that cys-leukotrienes are released and correlated with the impairment of the lung function after cardiac surgery in patients with COPD. If such hypothesis is substantiated in the study, it would allow us to propose the use of leukotriene inhibitors in the peri-operative period to improve pulmonary function and to decrease complications after cardiac surgery in COPD patients.

Official Title
-----------------
Changes in Leukotrienes During Cardiac Surgery in Patients With Chronic Obstructive Pulmonary Disease

Conditions
-----------------
Lung Dysfunction, Inflammatory Response During Cardiac Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients schedules to undergo cardiac surgery with use of CPB. Exclusion Criteria: inability to provide consent; previous diagnosis of asthma; acute pre-operative respiratory failure; emergency surgery.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1 Control<br>Patients with and without chronic obstructive pulmonary disease diagnosed before scheduling for cardiac surgery. | |
| 2 COPD<br>Patients with and without chronic obstructive pulmonary disease diagnosed before scheduling for cardiac surgery. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urine cysteinyl leukotriene |  | intra-operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, CPB, Leukotrienes
Adult Spinal Deformity Surgery Real-World Functional Activity

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure functional activity and stability in spinal deformity patients utilizing motion analysis testing and accelerometers.

Official Title
-----------------
Real-World Functional Activity in Adult Spinal Deformity Surgery

Conditions
-----------------
Degenerative Thoracolumbar Deformity

Intervention / Treatment
-----------------
* Device: Triaxial accelerometer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of degenerative thoracolumbar deformity Deformity correction surgery scheduled with either Dr. Elder or Dr. Fogelson, minimum 4-level fusion with fixation to the pelvis. Exclusion Criteria: ° Unable to return to Mayo Clinic for follow-up evaluation

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Activity Monitor Assessment<br>Subjects will be assessed in the Motion Analysis Laboratory at Mayo Clinic Rochester and have activity monitored in the free-living environment. | Device: Triaxial accelerometer<br>* Monitors placed on the waist, thigh, and bilateral ankles. Accelerometry will measure patients' physical activities in the free-living environment for 4 consecutive days. The patients will wear the monitor during waking hours and remove it during sleeping, showering, and swimming time.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motion Analysis Lab - Change in function | Spatiotemporal measures including velocity, step/stride length, step width, single/double support times, and R/L temporal symmetriesm will be used to measure function. | Baseline, 6-12 weeks post-surgery, 1 year | 
| Motion Analysis Lab - Change in gait | Gait will be measured by segmental and joint range of motion, peak kinetics during walking, and changes in deviation from normal bands using sensory processing measures. | Baseline, 6-12 weeks post-surgery, 1 year | 
| Motion Analysis Lab - Change in trunk stability | Trunk stability will be measured by EMG frequency content and activation pattern during gait and postural sway. | Baseline, 6-12 weeks post-surgery, 1 year |