linjc16/ctgov huggingface dataset:
The Etiology of New-onset Status Epilepticus

Study Overview
=================
Brief Summary
-----------------
This study will help to identify the causes of new epilepsy and provide a basis for the development of a rational and standardized diagnosis and treatment plan to reduce the rate of disability and death.

Official Title
-----------------
Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital

Conditions
-----------------
Status Epilepticus

Intervention / Treatment
-----------------
* Diagnostic Test: Perform autoimmune encephalitis titer tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Status Epilepticus Sign the informed consent form Exclusion Criteria: Patients with previous epilepsy Missing information such as basic information and treatment history Long-term smoking, alcohol and drug abuse Pregnant and breastfeeding women

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| status epilepticus with autoimmune encephalitis; status epilepticus without autoimmune encephalitis<br>To study the relationship between autoimmune-related antibody titres and prognosis during the six-month follow-up | Diagnostic Test: Perform autoimmune encephalitis titer tests<br>* We only follow up without intervention.<br>* Other names: We only follow up without intervention.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  | 2021-12--2022-12 |
Evaluation of a Prevention Program in Children and Teenagers at High Risk for Bipolar Disorder (Bipokid)

Study Overview
=================
Brief Summary
-----------------
Bipolar disorder is an early onset chronic disorder. Children of bipolar parents are at high risk of developping the same disorder and/or a psychopathology. Early intervention focused on emotion and problem solving strategies could improve their prognosis. The main objective of this trial is to evaluate the FFT (Family Focused Therapy) efficacity. Children emotional dysregulation profile will be compared before and after this CBT intervention.

Official Title
-----------------
Evaluation of a Prevention Program in Children and Teenagers at High Risk for Bipolar Disorder

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Behavioral: Family Focused Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children and teenagers from 6 to 16 years-old At least one biological parent with bipolar disorder T-score CBCL-Total ≥ 60 Written informed consent Exclusion Criteria: Active severe thymic episode Autism spectrum disorders Intellectual disability

Ages Eligible for Study
-----------------
Minimum Age: 6 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Family Focused Therapy<br>Only 1 arm | Behavioral: Family Focused Therapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CBCL-DP (Child Behavior Checklist - Dysregulation Profile) score variation |  | up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar disorder, Children, Family Focused Therapy, CBT
Stapler Post-market Observational Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to evaluate the safety and performance of the Endoscopic Linear Cutter Stapler and reloads from Fengh Medical used in laparoscopic Roux-en-Y gastric bypass surgery to create anastomoses. The goal of the study will be achieved by assessing the device performance and reporting of peri- and postoperative complications in a prospectively maintained database.

Official Title
-----------------
Assessing the Safety and Performance of the Endoscopic Linear Cutter Stapler in Laparoscopic Gastric Bypass Surgery.

Conditions
-----------------
Observational

Intervention / Treatment
-----------------
* Device: Endoscopic Linear Cutter Stapler and reloads


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age at study entry is at least 18 years. Patient must sign and date the informed consent form prior to the index-procedure. Patient has a BMI ≥ 35 kg/m with one or more related co-morbidity. Patient has a BMI ≥ 40 kg/m. Exclusion Criteria: Patient is pregnant. History of bariatric surgery. Patient is known to be, or suspected of being unable to comply with the study protocol or proposed follow-up visits.

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 |
| --- | --- |
| RYGB surgery<br>Obese patients eligible for laparoscopic Roux-en-Y gastric bypass (RYGB) surgery. | Device: Endoscopic Linear Cutter Stapler and reloads<br>* Endoscopic Linear Cutter Stapler and reloads<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events related to the index-procedure. | Determination of postoperative anastomotic leaks and intraluminal/intraperitoneal bleeding. | 1 month follow-up | 
| Number of patients with adverse events related to the index-procedure. | Determination of postoperative anastomotic leaks and intraluminal/intraperitoneal bleeding. | 6 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse device effects. | Determination of staple line disruption. | 1, 6, 12 and 24 month follow-up | 
| Number of patients with bariatric surgery related re-interventions. |  | 1, 6, 12 and 24 month follow-up | 
| Percentage of excess weight loss. | pre-operative weight (kg) minus postoperative weight (kg) divided by the ideal body weight (kg). | 1, 6, 12 and month follow-up | 
| Questionnaire on food tolerance. |  | 1, 6, 12 and 24 month follow-up |
A Study to Compare CSF Flow Metrics Across Platforms

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to find out more about detecting movement of CSF (fluid around the brain) with MRI. Researchers are doing this research study to find out how measurements of CSF movement differ among MRI machines and how image quality is changed by reducing the scan time.

Official Title
-----------------
Comparison of CSF Flow Metrics Across MRI Platforms

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - A healthy volunteer will be defined as an otherwise healthy person who does not have a medical condition that affects brain function or have problems with concentration, memory, balance, or coordination. Exclusion Criteria: - Subjects with non-MRI compatible devices, required sedation (claustrophobia or unable to remain still for exam), or women who are pregnant will be excluded.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of flow metrics among scanners | Flow metrics such as average total flow will be compared among multiple MRI scanners | February -December 2022 | 
| Comparison of flow metrics between scans with and without parallel imaging | Flow metrics such as the average total flow will be compared between sequences acquired with and without acceleration techniques, including parallel imaging, for a given scanner | February -December 2022 |
Oral Progestogen Supplementation in the Prevention of Recurrent Uterine Contraction in Preterm Labor

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of oral progesterone supplementation in preterm labor on the prevention of recurrent uterine contraction and prolonging pregnancy period, and its side effect.

Official Title
-----------------
A Randomized, Double Blinded, Placebo Controlled Trial of Oral Progestogen Supplementation in the Prevention of Recurrent Uterine Contraction in Preterm Labor

Conditions
-----------------
Preterm Labor

Intervention / Treatment
-----------------
* Drug: dydrogesterone
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton pregnancy Preterm labor GA24-34wk Intact membranes Exclusion Criteria: Maternal/fetal condition requiring immediate delivery ex. Chorioamnionitis, fetal distress Placenta previa medical and obstetric complications allergy to dydrogesterone

Ages Eligible for Study
-----------------
Minimum Age: 15 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dydrogesterone<br>tocolytic + corticosteroids + Dydrogesterone 10 mg/tablet prepare in capsule, 1 cap oral every 12 hours, starting form enrollment until gestational age 37 weeks | Drug: dydrogesterone<br> <br> * Other names: Duphaston;|
| Placebo Comparator: Placebo<br>tocolytic + corticosteroids + Placebo prepare in capsule, 1 cap oral every 12 hours, starting form enrollment until gestational age 37 weeks | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The recurrence of uterine contraction within 48 hours after stop tocolytic |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from preterm labor pain to delivery |  | 9 weeks | 
| Gestational age at delivery |  | 9 weeks | 
| Number of newborn with respiratory distress syndrome |  | 9 weeks | 
| side effects |  | 9 weeks | 
| Number of newborn with intraventricular hemorrhage |  | 9 weeks | 
| Number of newborn with necrotizing enterocolitis |  | 9 weeks | 
| Number of newborn with sepsis |  | 9 weeks |
Safety, Tolerability, and Pharmacokinetics Study of Human Monoclonal Antibody BRII-196

Study Overview
=================
Brief Summary
-----------------
This is a phase 1 study in which healthy adult volunteers will receive BRII-196 or placebo and will be assessed for safety, tolerability, and pharmacokinetics.

Official Title
-----------------
A Phase 1 Randomized, Single-blind, Placebo-controlled, Single Ascending Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Human Monoclonal Antibody, BRII-196 Administered Intravenously to Healthy Adult Volunteers

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Drug: BRII-196
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must be 18 to 49 years of age inclusive; Body weight ≤100 kg and body mass index (BMI) within the range of 19.0-24.0kg/m2 (inclusive); Male or female; Exclusion Criteria: Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation; A history of significant hypersensitivity, intolerance, or allergy to any drug compound; History of alcohol or other substance abuse;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>BRII-196 dose level 1 or placebo | Drug: BRII-196<br>* BRII-196 given intravenously<br>Drug: Placebo<br>* Placebo given intravenously<br>|
| Experimental: Cohort 2<br>BRII-196 dose level 2 or placebo | Drug: BRII-196<br>* BRII-196 given intravenously<br>Drug: Placebo<br>* Placebo given intravenously<br>|
| Experimental: Cohort 3<br>BRII-196 dose level 3 or placebo | Drug: BRII-196<br>* BRII-196 given intravenously<br>Drug: Placebo<br>* Placebo given intravenously<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) by CTCAE v5.0 |  | up to 24 weeks | 
| Proportion of subjects with SAEs |  | up to 24 weeks | 
| Proportion of subjects with infusion-related reactions |  | up to 24 weeks | 
| Proportion of subjects with hypersensitivity reactions |  | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Concentration of BRII-196 |  | up to 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19 phase I, monoclonal antibody
Defining the Molecular Risk in Israeli Patients With Secondary Compared to Primary Myelofibrosis

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to determine the rate of HMR mutations in PMF and secondary MF (post PV/ET) subjects, and correlate the rate of mutations with clinical features as known prognostic scores.

Detailed Description
-----------------
Main inclusion criteria: Diagnosis of PMF, post PV MF or post ET MF according to the WHO 2008 classification Age ≥ 18 years Concurrent participation in clinical trials will be allowed. Efficacy assessments will be evaluated by: HMR mutations rate, specific HMR mutations, disease duration, presence of splenomegaly, cytogenetic risk, DIPPS, IPSS, ET survival score and PV survival score. The primary efficacy parameter to be assessed will be HMR mutation rate.

Official Title
-----------------
Defining the Molecular Risk in Israeli Patients With Secondary Compared to Primary Myelofibrosis

Conditions
-----------------
Myelofibrosis, Primary, Myelofibrosis, Post PV, Myelofibrosis, Post ET

Intervention / Treatment
-----------------
* Other: Molecular analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of PMF, post PV MF or post ET MF according to the WHO 2008 classification Age . 18 years Patient is willing and capable of giving a written informed consent. Concurrent participation in clinical trials will be allowed Exclusion Criteria: Unwilling or unable to provide informed consent Prefibrotic MF

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Primary Myelofibrosis<br>Blood test | Other: Molecular analysis<br>* Blood test<br>|
| Other: Secondary Myelofibrosis<br>Blood test | Other: Molecular analysis<br>* Blood test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients with one or more HMR mutations in primary compared to secondary (post PV/ET) MF | Proportions of patients with HMR mutations in each arm | Baseline |
Proteasis Evaluation in COPD

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to evaluate kallikreins and its substrate, CCN, in COPD patients. Kallikreins are a subgroup of serine proteases, enzymes which are able to cleave peptide bonds in proteins. Kallicrein profile is unkonwn in COPD. The investigators will assess Kallikrein 1 to 15 and CCN 1 to 6 in sputum of patients. Three groups of patients will be included: Healthy smoker subjects, stable COPD patients and COPD patients with acute exacerbation. Kallicrein levels in sputum will be compared in these groups.

Official Title
-----------------
Proteasis Evaluation in COPD

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for healthy subjects: Smoker with tobacco consumption of 20 pack/year Normal lung function tests Exclusion Criteria for healthy subjects: diagnosis of lung disease during the study Asthma Lung cancer Pregnant and lactating women Inclusion Criteria for stable COPD: Smoker with tobacco consumption of 20 pack/year FEV1/FVC<70% on lung function tests no hospitalisation for exacerbation during 3 months before inclusion Exclusion Criteria for stable COPD: Asthma Lung cancer Pregnant and lactating women Inclusion Criteria for COPD with exacerbation: Smoker with tobacco consumption of 20 pack/year worsening of pulmonary symptoms FEV1/FVC<70% on lung function tests could be obtain before or 3 months after exacerbation Exclusion Criteria for COPD with exacerbation: Asthma Lung cancer Pregnant and lactating women

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Kallikrein level in sputum by ELISA |  | One sample at inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between kallikrein level and clinical or functionnal parameters | Correlation between kallikrein and FEV1 Correlation between kallikrein and dyspnea score | All data will be identified at inclusion |
Association Between Telomere Length and Risk of Acute Coronary Syndrome

Study Overview
=================
Brief Summary
-----------------
Compelling epidemiological evidence indicates that alterations length of telomere, are associated with the initiation and development of ischemic heart disease. This study was undertaken to investigate whether mtDNA copy number in peripheral blood leukocyte could be used as a risk predictor for acute coronary syndrome.

Official Title
-----------------
Short Telomere Length in Peripheral Blood Leukocyte Predicts the Risk of Acute Coronary Syndrome

Conditions
-----------------
Acute Coronary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -1.History of documented myocardial infarction; 2.Prior coronary revascularization intervention (coronary artery bypass graft surgery or percutaneous coronary intervention); 3.The presence of≥50% stenosis in one or more coronary arteries identified during cardiac catheterization; Exclusion Criteria: -1.History of malignancy or end-stage renal disease; 2.Blood transfusion within one month or prior bone marrow transplantation 3.Patients who reluctant to sign informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years


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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute coronary syndrome group<br>200 consecutive patients were recruited, who have diagnosed with acute coronary syndrom(ACS) by quantitative coronary angiography. | |
| Control group<br>The 200 healthy controls without previous CHD history were recruited from individuals who visited investigator's hospital for physical examination during the same time period as the case enrollment. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative telomere length | the ratio of telomere repeat copy number(T) to the hemoglobin(HGB) copy number (S) was determined for each sample using standard curves. The derived T/S ratio was proportional to the relative telomere length(RTL). In the second step, the T/S ratio of each sample was normalized to a calibrator DNA to standardize between different PCR runs. The calibrated T/S ratio was then used as the measurement of RTL in this study. | From date of percutaneous coronary intervention until the date of discharging from hospital, assessed up to 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute coronary syndrome, telomere length, predictive factor