linjc16/ctgov huggingface dataset:
INSIGHT - Post Marketing Surveillance

Study Overview
=================
Brief Summary
-----------------
In this international non-interventional post-marketing surveillance study we want to evaluate patient characteristics in HCC patients as well as efficacy and safety of Sorafenib (Nexavar®) treatment under daily-life treatment conditions. Specifically investigated are the tumor status, prior and/ or concomitant surgical, radiological and drug treatment and the duration of Sorafenib treatment.

Official Title
-----------------
International Study With Nexavar About Safety and Efficacy in Carcinoma Hepatocellular Therapy (HCC)

Conditions
-----------------
Carcinoma, Hepatocellular

Intervention / Treatment
-----------------
* Drug: Sorafenib (Nexavar, BAY43-9006)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In- and outpatients with diagnosis of hepatocellular carcinoma (HCC) and decision taken by the investigator to prescribe Nexavar Exclusion Criteria: Exclusion criteria must be read in conjunction with the local product information

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 |
| --- | --- |
| Group 1<br> | Drug: Sorafenib (Nexavar, BAY43-9006)<br>* Treatment of Hepatocellular Carcinoma with Nexavar (HCC)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: status of tumor, patients performance status |  | At each follow-up visit, every 2-4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of treatment |  | At each follow-up visit, every 2-4 months | 
| Time of survival |  | At each follow-up visit, every 2-4 months | 
| Reports of adverse events |  | At each follow-up visit, every 2-4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carcinoma, Hepatocellular, Sorafenib
BONAPH1DE, A Prospective Observational Study of Patients With Primary Hyperoxaluria Type 1 (PH1)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe the natural history and progression of patients diagnosed with PH1, and to characterize the long-term real-world safety and effectiveness of lumasiran.

Official Title
-----------------
BONAPH1DE, A Prospective Observational Study of Patients With Primary Hyperoxaluria Type 1 (PH1)

Conditions
-----------------
Primary Hyperoxaluria Type 1

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented diagnosis of PH1, per physician's determination Exclusion Criteria: Currently enrolled in a clinical trial for any investigational agent
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with PH1<br>Patients with a diagnosis of PH1 will be eligible for the study and will be managed and treated per routine clinical practice. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events in Lumasiran Treated Patients |  | Up to 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Selected Events of Interest in PH1 Patients | Selected events of interest are defined as hepatic events, kidney stones, acute kidney injury events, nephrocalcinosis, chromic kidney disease, kidney failure, and any cardiac, bone, skin, eye, hematological, or neuropathic manifestations due to oxalosis. | Up to 7 years | 
| 12-Item Short Form Health Survey Version 2 (SF-12 V2) (Standard Version) | SF-12 V2 is a 12-question measure capturing global quality of life and overall health status and evaluates the following 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. | Up to 7 years | 
| Change in Urinary Oxalate Excretion |  | Baseline and every 12 months for up to 7 years | 
| Change in Plasma Oxalate |  | Baseline and every 12 months for up to 7 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PH1, Lumasiran, Primary Hyperoxaluria Type 1
HER-2 Mutations in Tumor Samples From Patients With Advanced Non-Small Cell Lung Cancer Treated on Clinical Trial ECOG-2598

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Collecting samples of tumor tissue from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. PURPOSE: This laboratory study is looking at HER-2 mutations in tumor samples from patients with advanced non-small cell lung cancer being treated with trastuzumab on clinical trial ECOG-2598.

Detailed Description
-----------------
OBJECTIVES: Correlate clinical response to trastuzumab (Herceptin®) with the presence of mutation in the HER-2 kinase domain in tumor samples from patients with advanced non-small cell lung cancer treated on protocol ECOG-2598. Correlate mutations with time to progression and survival of these patients. OUTLINE: This is a multicenter study. Tissue specimens are analyzed by polymerase chain reaction to assess mutations in the HER-2 gene. Laboratory/biomarker analysis data is correlated with clinical data from protocol ECOG-2598. PROJECTED ACCRUAL: A total of 22-44 patients will be accrued for this study.

Official Title
-----------------
Evaluation of HER2 Mutations in Patient Tumors From E2598

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Genetic: gene expression analysis
* Genetic: mutation analysis
* Genetic: polymerase chain reaction
* Other: diagnostic laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of non-small cell lung cancer meeting ≥ 1 of the following criteria: Recurrent disease Stage IIIB with pleural or pericardial effusion Stage IV disease Treated on protocol ECOG-2598 PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: gene expression analysis|nan|
|Genetic: mutation analysis|nan|
|Genetic: polymerase chain reaction|nan|
|Other: diagnostic laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of HER-2 mutation with response, time to progression, and survival |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
Psychological Interventions in Siblings of Children With Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the effectiveness of a two-session brief psychological intervention in siblings of pediatric cancer patients with regard to behavior problems and depression.

Detailed Description
-----------------
Within a randomized controlled design the effects of a brief two-session psychological intervention (child, parents) shall be studied in 30 siblings of newly diagnosed pediatric cancer patients. After a baseline assessment 3-4 weeks after diagnosis participants are randomly assigned to an intervention or waiting list group. Both are re-assessed at 3 and 6 months by means of standardized questionnaires assessing psychological adaptation and behavior. The intervention is provided to the waiting list group after the 6-month assessment.

Official Title
-----------------
Psychological Interventions in Siblings of Children With Cancer: a Randomized Controlled Study

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Behavioral: Brief psychological intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: brother or sister with newly diagnosed cancer treated at the University Children's Hospital command of the German language normal developmental level Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 16 Years

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

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

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: Psychological Intervention<br>2-session psychological intervention | Behavioral: Brief psychological intervention<br>* Psychoeducation, provision of medical knowledge, coping skills training<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KIDSCREEN: health-related quality of life |  | baseline, 3 and 6 months post intervention | 
| UCLA Child PTSD Reaction Index |  | baseline, 3 and 6 months post intervention | 
| DIKJ (Depression-Inventory for Children and Adolescents) |  | baseline, 3 and 6 months post intervention | 
| Child Behavior Checklist |  | Baseline, 3 and 6 months post intervention | 
| Spence Children's Anxiety Scale |  | baseline, 3 and 6 months post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posttraumatic Distress Scale |  | baseline, 3 and 6 months post intervention | 
| Symptom Checklist 27 |  | baseline, 3 and 6 months post intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, siblings, behavior, psychological adaptation, intervention
Separation Versus Integrated Approach in Combining ECMO With CRRT

Study Overview
=================
Brief Summary
-----------------
This investigation aims to evaluate the filter life time of CRRT membrane and complication of combining ECMO and CRRT.

Official Title
-----------------
Separation Versus Integrated Approach in Combining ECMO With CRRT, a Randomized Controlled Trial

Conditions
-----------------
AKI

Intervention / Treatment
-----------------
* Device: Combination of extracorporeal membrane oxygenation and continuous renal replacement therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years Refractory acidosis (pH<7.2 or HCO3<15) Refractory volume overload Refractory hyperkalemia (K>6.2mEq/L or EKG change) Anuria or oliguria (urine output <0.5 mL/kg/hr for 6-12hr) High BUN >100 mg/dL or uremic symptom Increase intracranial pressure Exclusion Criteria: Pregnancy Not use heparin in ECMO Chronic kidney disease with CRRT AKI with Glomerulonephritis, Interstitial nephritis, Vassculitis or Urinary tract obstruction

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Separation technique<br> | Device: Combination of extracorporeal membrane oxygenation and continuous renal replacement therapy<br>* Combination of extracorporeal membrane oxygenation and continuous renal replacement therapy<br>|
| Integration technique<br> | Device: Combination of extracorporeal membrane oxygenation and continuous renal replacement therapy<br>* Combination of extracorporeal membrane oxygenation and continuous renal replacement therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circuit lifetime | The time until a CVVH malfunction was identified | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-Effectiveness | To evaluate the cost utility of CRRT between 2 groups | 72 hours |
Adherence to Mediterranean Diet and Phase Angle

Study Overview
=================
Brief Summary
-----------------
In this cross-sectional observational study the investigators evaluated the association between the adherence to the MD and PhA in a sample of adult population, stratified according to categories of sex, age, and BMI.

Official Title
-----------------
Influence of Mediterranean Diet on Phase Angle in a Sample of Adult Population: Results of a Pilot Study

Conditions
-----------------
Phase Angle, Mediterranean Diet

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Caucasian Subjects Healthy Subjects (defined as absence of a clinical condition that potentially influences fluid balance, ie, renal, endocrine, or myocardial disease, ascertained by participant questionnaire) Exclusion Criteria: Hypocaloric diet in the last three months or specific nutritional regimens, including vegan or vegetarian diets, Vitamin/mineral or antioxidant supplementation, Clinical conditions that could influence fluid balance, including liver or renal failure, cancer, and acute or chronic inflammatory diseases, based on a complete medical examination and laboratory investigations, Occasional or current of use of drugs that could influence fluid balance, including non-steroidal anti-inflammatory drugs, hormone replacement therapy, diuretics weight-loss medications, anticonvulsivants and psychotropic agents, laxative use, Altered thyroid hormone function tests or thyroid hormone treatment, Alcohol abuse according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-V diagnostic criteria, Patients with implanted pacemakers or defibrillators because of the theoretical possibility of interference with the device activity due to the field of current induced by the impedance measurements, Subjects underweight with BMI<18.5, Subjects dropped out from the study since they refused to participate.

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to Mediterranean Diet by Predimed Questionnaire |  | January 2010 - May 2016 | 
| Phase Angle by Bioimpedance Analysis |  | January 2010 - May 2016 |
Guangzhou Women's Health Cohort Study (GWHCS)

Study Overview
=================
Brief Summary
-----------------
The Guangzhou Women's Health Cohort Study aims to explore the health trajectory and factors contributing to the health of women aged 35-64 in Guangzhou. Based on multiple population health registration data platforms, data of the cohort will provide information about the health of women across the lifespan, facilitating the decision-making process by local government . The cohort is progressing steadily, and the goal is to build a large women cohort covering 11 administrative districts of Guangzhou with a scale of 1 million by 2030.

Detailed Description
-----------------
The Guangzhou Women's Health Cohort Study aims to explore the health trajectory and factors contributing to the health of women aged 35-64 in Guangzhou. Based on multiple population health registration data platforms, data of the cohort will provide information about the health of women across the lifespan, facilitating the decision-making process by local government . The cohort is progressing steadily, and the goal is to build a large women cohort covering 11 administrative districts of Guangzhou with a scale of 1 million by 2030.

Official Title
-----------------
Guangzhou Women's Health Cohort Study (GWHCS)

Conditions
-----------------
Cervical Cancer, Breast Cancer, Lung Cancer, Colorectal Cancer, Endometrial Cancer, Ovarian Cancer, Hypertension, Diabetes, Reproductive Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged 35-64 years old Women with registered permanent residence in Guangzhou Women with informed consent Exclusion Criteria: Women without informed consent Women with reading and/or writing difficulties Women with serious mental disorders

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 64 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 |
| --- | --- | --- |
| Incidence and mortality rate of cancer | Data from cancer registration platforms | through study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypertension and diabetes | Data from questionnaire | through study completion, an average of 2 years | 
| Reproductive health | Data from questionnaire | through study completion, an average of 2 years |
The Association Between Monocyte Subsets and Coronary Collateral Development in Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
Monocyte heterogeneity in peripheral blood seems to be important in coronary collateral development in non-diabetic patients with stable coronary artery disease. Our aim in this study is to find out any possible relationship between the levels of circulating monocyte subsets and coronary collateral development in type 2 diabetic patients.

Detailed Description
-----------------
83 diabetic patients with severe coronary artery disease were enrolled in the study. These patients were investigated according to their collateral development. Monocytes and their subtypes, namely CD14++CD16- and CD14+CD16+ cells were compared in 2 groups

Official Title
-----------------
The Association Between Monocyte Subsets and Coronary Collateral Development in Diabetes Mellitus

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: presence of > 95% stenosis of at least one major coronary artery in their first coronary angiogram. Exclusion Criteria: Patients experiencing acute coronary syndrome either with or without ST elevation in the last one month Evidence of ongoing infection and inflammation, known malignancy and chronic kidney disease

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 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 |
| --- | --- |
| Collateral, coronary disease<br>Patients are grouped into 2: Good and poor collateral development | |
| collateral<br>Patients are grouped into 2: Good and poor collateral development | |

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
-----------------
Coronary collaterals, diabetes mellitus, monocyte subsets
Truth or Dare; Artificial Blastocoel Collapse Using Laser Before Blastocyst's Vitrification Versus Non-laser Usage

Study Overview
=================
Brief Summary
-----------------
: This prospective randomized observational study aimed to compare behavior of artificially collapsed blastocysts to blastocysts that were vitrified without artificial collapse.

Detailed Description
-----------------
One arm study of 60 patients with sibling blastocysts divided into 2 groups: Study group (artificially laser-collapsed blastocysts; n=71) & control group (blastocysts were vitrified without laser collapse; n=66) then reexpansion speed and survival rate was assessed immediately & at 140 min after thawing and compared between two groups.

Official Title
-----------------
Truth or Dare; Artificial Blastocoel Collapse of Human Blastocysts Before Vitrification

Conditions
-----------------
Blastocyst Disintegration

Intervention / Treatment
-----------------
* Device: laser assisted collapse


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age limit 20-37 At least 6 good quality blastocysts per case. expansion rate 3-4 Exclusion Criteria: bad quality blastocysts expansion rate less than 3

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 37 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: patients with sibling blastocysts divided into 2 groups: Study group (artificially laser-collapsed blastocysts; n=71) & control group (blastocysts were vitrified without laser collapse; n=66) then reexpansion speed and survival rate was assessed immediately & at 140 min after thawing and compared between two groups.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group (artificially laser-collapsed blastocysts)<br>laser was used as an intervention before blastocyst vitrification to assist rapid blastocyst collapse with vitrification | Device: laser assisted collapse<br>* Apply 1-2 pulses of laser using the Saturn between 2 adjacent trophectoderm cells away from the inner cell mass in the blastocysts<br>|
| No Intervention: & control group (blastocysts were vitrified, no laser collapse<br>blastocyst were vitrified without laser assisted collapse | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival rate | survival rate will be assessed immediately after thawing and compared between both groups. | immediately after thawing | 
| survival rate | survival rate will be assessed at 140 minutes after thawing and compared between both groups. | 140 min after thawing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blastocyst, Vitrification, artificial collapse, survival rate