linjc16/ctgov huggingface dataset:
Copenhagen Prospective Personalized Oncology (CoPPO)

Study Overview
=================
Brief Summary
-----------------
Patients with advanced solid tumors referred to the Phase 1 Unit are offered mapping of GA for identification of pts who could benefit from a personalized treatment.

Detailed Description
-----------------
Two ultrasound-guided biopsies obtained to be stored in RNAlater® for DNA and RNA purification. A 3rd biopsy for histology is paraffin embedded. SNP-array (Affymetrix Cytoscan HD) from DNA (tumor) is performed to identify copy number changes. Whole exome sequencing (WES) from DNA (tumor and blood) will be performed using sequence capture, SureSelect v5 (Agilent) and Illumina HiSeq2500 to call tumor specific mutations. Expression levels of therapeutic targets are revealed by expression Array from tumor RNA. In addition to the expression array, RNA-seq (Nugens Ovation RNA-seq system v2) is performed to investigate whether chromosomal translocations were the reason for tumor specific expression of an oncogene. Results will be reviewed by a tumor board. Patients with specific genetic profiles that can be targeted with marketed drugs or drugs under development are offered such treatment. PFS from the treatment is compared to PFS of the most recent standard treatment (PFS ratio).

Official Title
-----------------
A Prospective Study Using Genomic Screening to Select Patients for Targeted Molecular Treatment

Conditions
-----------------
Unspecified Adult Solid Tumor, Protocol Specific

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Solid tumor No standard treatment option PS 0-1 Lesion assessable for biopsy Measurable disease Informed consent Exclusion Criteria: Life expectancy < 3 months Bone marrow suppression Abnormal renal or hepatic function Serious concurrent medical conditions

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tumor biopsy<br>Tumor biopsy for targeted treatment according to molecular profile | Procedure: Tumor biopsy<br>* Biopsy of lesion for molecular characterization<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median progression free survival (PFS) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months | Median time from date of randomization to date of progression or death, assessed up to 100 months |
The SOURT OUT IV TRIAL

Study Overview
=================
Brief Summary
-----------------
In a randomized study the Xience V coroary artery stent may be non inferior to the Cypher Select+ coronary stents in the treatment of unselected patients with coronary artery disease.

Detailed Description
-----------------
2 Purpose In a randomized study to compare the Cypher Select+ and the Xience V coronary stents in the treatment of unselected patients with coronary artery disease. 2.1 Primary objective In a randomized study to compare the Xience V and the Cypher Select+ coronary stents by assessing SAFETY (cardiac death, myocardial infarction and/or stent thrombosis) and EFFICACY (target vessel revascularization) after 9 months. 2.2 Secondary objective To compare device success rate, procedure success rate and complication rate during hospitalization, after 1 month and after 9 months and the incidence of late stent thrombosis after 12, 24 and 36 months.

Official Title
-----------------
Randomized Clinical Comparison of the Xience V and the Cypher Coronary Stents in Non-selected Patients With Coronary Heart Disease

Conditions
-----------------
Ischemic Heart Disease, Coronary Atherosclerosis, Percutaneous Coronary Intervention

Intervention / Treatment
-----------------
* Device: Percutaneous coronary intervention (Xience V stent)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients treated with one or more drug eluting stents in the coronary arteries at one of the 5 heart centres in Denmark (Gentofte, Rigshospitalet, Odense, Skejby, Aalborg) can be included in the study. Exclusion Criteria: The patient will not participate The patient participates in other randomised stent studies Expected survival < 1 year Allergy to Aspirin, Clopidogrel or Ticlopidine Allergy to Sirolimus or ABT-578

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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Cypher Select plus stent | Device: Percutaneous coronary intervention (Xience V stent)<br>* Cypher Select plus coronary stent Xience V coronary stent<br>* Other names: Xience V coronary stent;|
| Active Comparator: 2<br>Xience V stent | Device: Percutaneous coronary intervention (Xience V stent)<br>* Cypher Select plus coronary stent Xience V coronary stent<br>* Other names: Xience V coronary stent;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SAFETY (cardiac death, myocardial infarction and/or stent thrombosis) EFFICACY (target vessel revascularization) |  | 9 months, 1 year, 2 years, 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCI, Drug-eluting stent
Web-Based CBT Protocol for Treatment of Selective Mutism

Study Overview
=================
Brief Summary
-----------------
The main aim of this study is to examine the effectiveness of a web-based CBT protocol (entitled Meeky Mouse) in the treatment of children with Selective Mutism in Singapore. The researchers hypothesized that the Meeky Mouse program would be associated with higher frequency of speaking behaviors, lower levels of anxiety, greater improvements in clinician-rated severity of mental illness, and higher clinician-rated improvement scores at post-treatment.

Official Title
-----------------
Effectiveness of a Web-Based CBT Protocol for Treatment of Selective Mutism in Singapore

Conditions
-----------------
Selective Mutism

Intervention / Treatment
-----------------
* Behavioral: Meeky Mouse program
* Other: Computer Games


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 6-12 years old primary clinical diagnosis of Selective Mutism confirmed diagnosis of Selective Mutism by structured clinical parent interview fluent in English Exclusion Criteria: below average intellectual functioning the presence of autism and schizophrenia

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meeky Mouse program<br>14-week Meeky Mouse program consists of 8 training sessions (psychoeducation and anxiety management) followed by 6 practice sessions (exposure using social skills training) | Behavioral: Meeky Mouse program<br> <br> |
| Placebo Comparator: Computer Games<br>14 weeks of interactive session with the therapist while playing computer games | Other: Computer Games<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Selective Mutism Questionnaire |  | Changes from pre-treatment (Week 0) to post-treatment (Week 14) on SMQ scores | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asian Children's Anxiety Scale-Caretaker Version (ACAS) |  | Changes from pre-treatment (Week 0) to post-treatment (Week 14) on ACAS total scores | 
| Asian Children's Anxiety Scale-Child (ACAS-C) |  | Changes from pre-treatment (Week 0) to post-treatment (Week 14) on ACAS-C total scores | 
| Clinical Global Impression (CGI) |  | Changes from pre-treatment (Week 0) to post-treatment (Week 14) on CGI-Severity and CGI-Improvement Ratings | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anxiety, frequency of speech, selective mutism
Association of SCNN1A Single Nucleotide Polymorphisms With Neonatal Respiratory Distress Syndrome

Study Overview
=================
Brief Summary
-----------------
Lung fluid absorption disorders are largely mediated by transepithelial Na+ reabsorption through alpha epithelial sodium channels (α-ENaCs) in alveolar epithelial cells. Increasing evidence has demonstrated that these lung disorders might be an important cause of neonatal respiratory distress syndrome (NRDS) by influencing gas exchange or surfactant function, particularly in near-term and term infants. The SCNN1A gene, which encodes the α-ENaC, might predispose infants to NRDS. To explore whether the single-nucleotide polymorphisms (SNPs) of SCNN1A are associated with NRDS, we conducted a case-control study to investigate the NRDS-associated loci in Han Chinese infants. Seven target SNPs were selected from the SCNN1A gene and were genotyped using the improved multiplex ligase detection reaction (iMLDR).

Official Title
-----------------
Association of SCNN1A Single Nucleotide Polymorphisms With Neonatal Respiratory Distress Syndrome

Conditions
-----------------
Neonatal Respiratory Distress Syndrome

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newborns with RDS Exclusion Criteria: The infants were excluded if they had any congenital malformation, inherited metabolic abnormalities, intrauterine infection, Rh/Rh incompatibility, pneumonia, pulmonary hypertension, meconium aspiration syndrome, or asphyxia

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 28 Days

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group<br>The control blood samples, which were collected from healthy neonatal umbilical cord blood, were obtained from the maternity ward of 80 hospitals in Chongqing and nearby areas | Other: no intervention<br>* no intervention<br>|
| RDS group<br>Newborns with RDS were consecutively recruited for this study from the neonatal intensive care unit (NICU) at Daping Hospital, Third Military Medical University, Chongqing, China, a tertiary care facility | Other: no intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genotype distributions of target SNPs in RDS group and Control group | Compare the genotype and allele frequencies of target SNPs between RDS group and the control group | within 28 days after birth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SCNN1A, Lung fluid absorption disorders, Neonatal respiratory distress syndrome, Single nucleotide polymorphism
Mifepristone and Misoprostol Compared With Misoprostol Alone for Second Trimester Abortion

Study Overview
=================
Brief Summary
-----------------
Mifepristone and Misoprostol Compared With Misoprostol Alone for Second Trimester Abortion - a Double Blinded Randomized Controlled Trial

Official Title
-----------------
Mifepristone and Misoprostol Compared With Misoprostol Alone for Second Trimester Abortion

Conditions
-----------------
Second Trimester Abortion

Intervention / Treatment
-----------------
* Drug: Mifepristone
* Drug: Placebo
* Drug: Misoprostol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy no allergy known to these drugs second trimester abortion Exclusion Criteria: hematology diseases clotting factor deficiency

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MISOPROSTOL alone<br>the common practice currently in our medical center for second trimester medical abortion/ Placebo | Drug: Placebo<br>* The group that will only get Misoprostol<br>Drug: Misoprostol<br>* Both groups will get think drug<br>|
| Experimental: Mifepristone and Misoprostol<br>in addition to the common practice currently in our medical center for second trimester medical abortion we will add Mifepristone before administering Misoprostol. Mifepristone | Drug: Mifepristone<br>* The group that will get in addition to Misoprostol also Mifepristone<br>Drug: Misoprostol<br>* Both groups will get think drug<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Hospital Stay Duration | number of days of hospital stay | Up to 24 months |
Study of Eye Movements as Markers of the Physiological, Cerebral and Cognitive State of Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The goal of this study is the multimodal exploration via eyetracking, MRI and EEG data of ocular movements and the corresponding brain activation during ecologic visual stimulation in the healthy population.

Detailed Description
-----------------
Cerebral activation following visual stimulation is explored using two neuroimaging techniques EEG and MRI while eye movements are recorded. Three experiments are performed: in MR scanner 1) functional localisation of specific areas: LOC, FFA, MT/V5, V1 and V2 and 2) a saccadic choice experiment; with EEG, replication of the experiments performed in the MR scanner and 3) an additional experiment of movement detection during the ocular saccades. Thirty young volunteers (18-40 y old) are involved.

Official Title
-----------------
Study of Eye Movements as Markers of the Physiological, Cerebral and Cognitive State of Healthy Subjects

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

Intervention / Treatment
-----------------
* Other: Neuroimaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal vision or corrected to normal Social security affiliation Signed consent to participate No pregnancy fo women Exclusion Criteria: Audition and motor troubles Incapable to decide (Persons mentioned in L1121-5,6 et 8 of public health code) Neurological disorders Pathology affecting oculomotor control MRI incompatibility

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Subjects<br>All healthy subject are gathered in one arm | Other: Neuroimaging<br>* MR, EEG recordings<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eye movement brain networks | Identification of the cerebral locus of ocular movement via MRI & EEG | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OculoDB | Database repository of healthy population | 24 months |
Evaluation of Intra-Abdominal Fat in Patients With Type 2 Diabetes Using a Non-Invasive Method

Study Overview
=================
Brief Summary
-----------------
The main aim of this study is to compare 2 different measurements of visceral fat that can be easily used in clinical practice (waist circumference versus bioelectric impedance) in relation to known risk factors of coronary artery disease in a large cohort of patients with type 2 diabetes and with a BMI range between 20-45 kg/m2

Official Title
-----------------
Evaluation of Intra-Abdominal Fat Contents in Patients With Type 2 Diabetes Using a Novel Non-Invasive Method of Bioelectric Impedance

Conditions
-----------------
Obesity, Type 2 Diabetes, Metabolic Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Established type 2 diabetes Age 18 - 80 Body mass index (BMI) between 20-45 Kg/m2. Willing to undergo laboratory and anthropometric assessments. Exclusion Criteria: The study will not include women who are pregnant, or are not using reliable birth control methods or who they think that they might be pregnant due to potential risk of fetal affection. Subjects with known malignancy, treated or untreated will be excluded (except treated skin melanoma). Subjects with major psychological problems or a major eating disorder will be excluded. Subjects with heart Pacemaker or any other electronic devices attached to their body will be excluded. Subjects with confirmed type 1 diabetes or positive anti GAD antibodies test will be excluded

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Visceral fat level |  | immediate | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Visceral Fat, Waist Circumference, Bioelectrical Impedance, Metabolic Syndrome, Obesity, Type 2 Diabetes
Effect of Climatic Factors on the Seasonal Fluctuation of Pulmonary Embolism

Study Overview
=================
Brief Summary
-----------------
To estimate the risks of daily hospital admissions for pulmonary embolism associated with short term exposure to climatic factors (temperature, precipitation, air pressure, sunshine duration, relative humidity, wind speed, and ambient fine particulate matter [aerodynamic diameter ≤2.5 μm; PM2.5]) in China.

Detailed Description
-----------------
Hospital admissions for pulmonary embolism were identified based on the primary diagnosis. The central adjudication committee at Peking Union Medical College Hospital (Beijing, China) reviewed all medical and death records and determined the final diagnosis. Two adjudication committee members verified events independently, and discrepancies were resolved by discussion involving additional committee members.For each admission, we extracted data on the date of admission, sex, age, and location of the patient from hospital information system. All the data of daily meteorological variables for the same period, including temperature variables (°C) (the min, max and mean temperature), relative humidity (%), air pressure (hPa), precipitation (mm), wind speed (m/s) and sunshine duration (h), were collected from the China Meteorological Data Sharing Service System (http://www.escience.gov.cn/metdata/page/index.html). The data on PM2.5 levels in each city was collected from the National Air Pollution Monitoring System. An overdispersed generalised additive model was used to estimate associations between climatic factors and pulmonary embolism admissions. A distributed lag non-linear model (DLNM) was employed to examine their lagged effects.

Official Title
-----------------
Association Between Climatic Factors and Hospital Admissions for Pulmonary Embolism: Time Series Study in China Between Years 2014 to 2019.

Conditions
-----------------
Pulmonary Embolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females. With a primary diagnosis of pulmonary embolism based on clinical symptoms, with or without radiologic features. Exclusion Criteria: Lack of important data.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observation<br>Observation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of pulmonary embolism | Daily counts of hospital admissions for primary diagnoses of pulmonary embolism among different demographic groups were used to estimate the associations between climatic factors and morbidity. | From July 31, 2014 to July 31, 2019 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary Embolism, Climate