linjc16/ctgov huggingface dataset:
Effectiveness of Atypical Versus Conventional Antipsychotics in Treating Schizophrenia

Study Overview
=================
Brief Summary
-----------------
This study will compare the effectiveness of newer atypical antipsychotics versus older conventional antipsychotics in treating schizophrenia.

Detailed Description
-----------------
At seven participating hospitals, acutely exacerbated patients with schizophrenia were randomly assigned to treatment with antipsychotic from the atypical class vs antipsychotic from the conventional class. Medication choice within class, dose, concomitant medications, and other prescribing decisions were left to the community prescriber. Patients were followed for one year after discharge.

Official Title
-----------------
Effectiveness of Atypical Vs Conventional Antipsychotics

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: risperidone
* Drug: olanzapine
* Drug: quetiapine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hospitalized for schizophrenia Exclusion Criteria: none
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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: risperidone|nan|
|Drug: olanzapine|nan|
|Drug: quetiapine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PANSS |  |  | 
| Retention. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EPS, TD. |  |  |
Measuring Quality in Colorectal Cancer Surgery in Low- and Middle-income Countries

Study Overview
=================
Brief Summary
-----------------
To test the applicability of the Clavien-Dindo Classification (CDC) in an LMIC setting and to compare the prevalence and severity of complications in patients <60 and ≥60 years of age a retrospective medical records review is used.

Detailed Description
-----------------
Background: Colorectal cancer (CRC) is increasing in Low- and Middle-Income Countries (LMIC) as part of the ongoing epidemiological transition. Surgery is the main treatment and the global health agenda is increasingly putting focus on improving the safety and quality of surgical care in low-resource settings. The current systems for measuring surgical quality are mainly customized for high-income countries. Aim: To test the applicability of the Clavien-Dindo Classification (CDC) in an LMIC setting. Additionally, to compare the prevalence and severity of complications in patients <60 and ≥60 years of age. Material and methods: Retrospective medical records review for postoperative complications and severity grading using the CDC.

Official Title
-----------------
Measuring Quality in Colorectal Cancer Surgery in Low- and Middle-income Countries: the Clavien-Dindo Classification in a Sri Lankan Cohort

Conditions
-----------------
Colorectal Cancer, Postoperative Complications, Surgical Complication, Non-communicable Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who has gone through colorectal cancer resection. Surgery performed at Colombo South Teaching Hospital in Colombo, Sri Lanka. Exclusion Criteria: Reason for resection other than colorectal cancer.
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 |
| --- | --- | --- |
| Clavien-Dindo Grade | Postoperative complications graded by the Clavien-Dindo Classification. | February 2020 to March 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age comparison | Comparison of prevalence and severity of complications between patients <60 and ≥60 years of age. | February 2020 to March 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colorectal cancer, Sri Lanka, Clavien-Dindo Classification, Postoperative complications, Surgical quality
Clinical Characteristics of Acute Pulmonary Embolism in Chinese Population

Study Overview
=================
Brief Summary
-----------------
There are no special clinical characteristics of acute pulmonary embolism in Chinese population.

Official Title
-----------------
Clinical Characteristics of Acute Pulmonary Embolism in Chinese Population

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the symptomatic acute PE confirmed by objective examination Exclusion Criteria: congestive heart failure chronic obstructive pulmonary disease; a prior documented episode of PE or DVT renal dysfunction; a life expectancy of less than 6 months

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 85 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 2<br> | |
| group 1<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary end point of the present study was symptomatic, objectively confirmed recurrent fatal or nonfatal VTE. |  | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The second end point was death (all cause death and PE-related death). | If the participant died, the relatives need provided the written medical record on the death. | 60 months |
Pharmacokinetics of Progesterone in Pregnancy

Study Overview
=================
Brief Summary
-----------------
Pharmacokinetic analysis of 200mg vaginal progesterone suppository in women with singleton pregnancies between 18 0/7- 23 6/7 weeks' gestation

Detailed Description
-----------------
Prospective study of 6 women with singleton pregnancies 18 0/7- 23 6/7 weeks' gestation with no prior preterm birth or short cervix who are administered a single dose of 200mg vaginal progesterone suppository. Serum progesterone levels will be drawn serially from pre-dose to 24 hours post-dose.

Official Title
-----------------
Pharmacokinetics of Vaginal Progesterone in Pregnancy

Conditions
-----------------
Progesterone

Intervention / Treatment
-----------------
* Drug: vaginal progesterone suppository


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18 years old pregnant with singleton gestation 16 0/7 - 23 6/7 weeks pre-pregnancy BMI 20-40 no history of prior preterm birth Exclusion Criteria: history of an adverse reaction to progesterone contraindication to progesterone treatment including prior or active thrombus, active hepatic disease, known adverse reaction to progesterone medical comorbidity requiring medication including: hypertension, diabetes, substance abuse/methadone maintenance therapy, asthma, thyroid disease major fetal anomaly diagnosed on ultrasound or known chromosomal disorder multifetal gestation vaginal bleeding, preterm labor, premature rupture of membranes, or clinical chorioamnionitis, at the time of enrollment or on Day 1 of study any progesterone use of any form previously during the pregnancy active vaginitis Illicit substance use in pregnancy including cocaine, opiates, marijuana abnormal pap smear/+HPV on most recent pap smear known or suspected malignancy of the breast or genital organs cervical length ≤25mm

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Pharmacokinetic study to assess plasma concentration time profile of vaginal progesterone in pregnant women.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Vaginal Progesterone<br>micronized progesterone vaginal suppository 200mg | Drug: vaginal progesterone suppository<br>* 200mg vaginal suppository micronized progesterone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic model | Plasma concentration time profile of vaginal progesterone in pregnant women. | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
progesterone, pharmacology, pharmacokinetics
Non-interventional Cross-over Study to Reduce Items of PROactive Tools Measuring Physical Activity in Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
The purpose of the protocol is to develop final draft PRO instruments of physical activity in daily life to be used and evaluated in the further validation studies measuring physical activity in chronic obstructive pulmonary disease (COPD) patients.

Official Title
-----------------
Non-interventional Cross-over Study to Reduce Items of the Draft PROactive Tools as a Measure of Physical Activity in Daily Life in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Conditions
-----------------
Chronic Obstructive Pulmonary Disease (COPD)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of COPD (Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria: post bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC)<70%) confirmed with spirometry in stable clinical conditions. For patients recruited during an exacerbation, the diagnosis of COPD should be confirmed in stable conditions. Current or ex-smokers with a smoking history equivalent to at least 10 pack years. Able to read and write and to use electronic devices and physical activity monitor. Exclusion Criteria: Orthopaedic, neurological or other complaints that significantly impair normal biomechanical movement patterns, as judged by the investigator. Respiratory diseases other than COPD (e.g. asthma). Cognitive impairment, as judged by the investigator

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Arm 1 - Daily+Clinical<br>Order of assessment: Daily PRO + Clinical visit PRO | |
| Arm 2 - Clinical+Daily<br>Order of assessment: Clinical visit PRO + Daily PRO | |

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
-----------------
Physical Activity, Patient Reported Outcome (PRO), Chronic obstructive pulmonary disease (COPD), Innovative Medicines Initiative - Joint Undertaking (IMI-JU)
Persistence of the Immune Response to Hepatitis B in 4-6 Years Old Children Previously Vaccinated With DTPa-HBV-IPV/Hib

Study Overview
=================
Brief Summary
-----------------
Persistence of seroprotective antibody concentrations & immunological memory shown by the ability to mount a response to a challenge dose of HBV vaccine

Official Title
-----------------
Multicentre Study to Assess Persistence of Antibodies Against Hepatitis B & Immune Response to a Hepatitis B Challenge Dose in Healthy Children 4 to 6 Years Old Previously Vaccinated With 4 Doses of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine

Conditions
-----------------
Hepatitis B

Intervention / Treatment
-----------------
* Biological: hepatitis B vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A male or female aged 4 to 6 years at the time of study entry . Subjects who have received a total of 4 doses of DTPa-HBV-IPV/Hib vaccine in previous vaccination studies. Evidence of previous hepatitis B booster vaccination or disease since administration of the fourth dose of DTPa-HBV-IPV/Hib vaccine.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 6 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: hepatitis B vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HBs antibody concentration |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistence of antibodies to the other DTPa-HBV-IPV/Hib vaccine antigens. |  |  | 
| Sol & unsol symptoms after HBV vaccination, SAEs |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prophylaxis for hepatitis B disease
Developmental Outcomes

Study Overview
=================
Brief Summary
-----------------
Determine whether the concentrations of UCH-L1 and GFAP measured in umbilical cord blood and in blood 0-6 hours postnatal accurately predict the extent of neurodevelopmental deficits and/or death at 18-20 months.

Detailed Description
-----------------
Children born with Hypoxic Ischemic Encephalopathy (HIE) and already enrolled in IRB #504-2011 will be seen for a developmental follow-up at 18-20 months of age. The developmental assessment tool that will be used is called the Bayley Scales of Infant and Toddler Development: 3rd Edition (Bayley-III) Screening Test. The results of this test will then be compared to the child's HIE biomarkers concentrations already obtained at birth.

Official Title
-----------------
Clinical Utility of Serum Biomarkers for the Management of Neonatal Hypoxic Ischemic Encephalopathy (HIE).

Conditions
-----------------
Hypoxic-Ischemic Encephalopathy

Intervention / Treatment
-----------------
* Other: Developmental Outcomes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children already enrolled in IRB#504-2011 18-20 months of age Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 20 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Developmental outcomes<br>A developmental assessment (Bayley-III) of children 18-20 months who already enrolled in Florida Neonatal Neurologic Network. As part of this previous study, these children were born with Hypoxic Ischemic Encephalopathy (HIE) and underwent therapeutic cooling after birth. | Other: Developmental Outcomes<br>* A Bayley-III developmental assessment will be performed study subjects at age 18-20 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bayley-III developmental assessment in children, with Hypoxic Ischemic Encephalopathy (HIE) diagnosis at birth, at 18-20 months of age | Compare Developmental Outcomes to HIE Biomarker concentrations at birth | 2 years |
Investigation of the Relationship Between Sensory Processing and Kinesychophobia in Fibromyalgia Patients

Study Overview
=================
Brief Summary
-----------------
Fibromyalgia; is a chronic and rheumatic condition characterized by diffuse pain. In patients with fibromyalgia syndrome, there is an increase in psychiatric symptoms, especially depression, anxiety, and somatoform disorders. Kinesophobia is defined as anxiety against pain and pain caused by painful injury and re-injury. The aim of this study was to investigate the relationship between kinesophobia and sensory processing in patients with fibromyalgia.

Detailed Description
-----------------
Fibromyalgia; is a chronic and rheumatic condition characterized by diffuse pain. In patients with fibromyalgia syndrome, there is an increase in psychiatric symptoms, especially depression, anxiety, and somatoform disorders. Kinesophobia is defined as anxiety against pain and pain caused by painful injury and re-injury. The aim of this study was to investigate the relationship between kinesophobia and sensory processing in patients with fibromyalgia.

Official Title
-----------------
Investigation of the Relationship Between Sensory Processing and Kinesychophobia in

Conditions
-----------------
Fybromyalgia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-65 years old Diagnosed by fibromyalgia No other known physical, neurological and psychological illness Literate Volunteers to participate in the study Exclusion Criteria: Not compliant with inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensory processing assessed with the Sensory Adolescent / Adult Sensory Profile Questionnaire | Sensory processing disorder refers to the difficulty of processing the information coming from the sensory organs, and the inefficiency of the normal sensory processing process.For the evaluation of sensory processing; Sensory Adolescent / Adult Sensory Profile questionnaire will be used. | at the end of the third month | 
| Knesychophobia assessed with the Tampa Kineshiophobia Scale | Kinezyophobia is defined as anxiety against pain and pain caused by painful injury and re-injury. For the evaluation of kinesiophobia; Tampa Kineshiophobia Scale will be used. | at the end of the third month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sensory processing, fybromyalgia, kinezyhophobia
Generation of Haploid Stem Cells From Human Germ Cells

Study Overview
=================
Brief Summary
-----------------
Human cells are diploid (contain a double set of chromosomes). The diploid genome is complex and therefore limits genetic research approaches in biomedical models. To overcome this problem experimental generation of haploid stem cells has been done in animals. The investigators aim at generating haploid stem cells from human germ cells that are a useful tool in genetic research and screening.

Detailed Description
-----------------
Human cells are diploid (contain a double set of chromosomes). The diploid genome is complex and therefore limits genetic research approaches in biomedical models. To overcome this problem experimental generation of haploid stem cells has been done in animal models. haploid cells are easier for genetic manipulations, such as knock-in and knock-out of genes, and therefore should make a better experimental model. The investigators aim at generating haploid stem cells from human haploid germ cells.

Official Title
-----------------
Generation of Haploid Stem Cells From Human Germ Cells

Conditions
-----------------
Induced Pluripotent Stem Cells

Intervention / Treatment
-----------------
* Other: generation of stem cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: males over the age of 18 and under 50 no known chronic illness not taking any chronic drugs Exclusion Criteria: females males under 18 or over 50 any known chronic illness taking chronic medications

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sperm sample from healthy volunteers<br> | Other: generation of stem cells<br>* Collected germ cells will be cultured in medium. The germ cell cultures will be infected with reprograming factors. Rare colonies with characteristic stem cell morphologies will be expanded.<br>* Other names: generation of stem cells from somatic haploid germ cells;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients donated samples | No samples collected to date | June 2011-November 2013 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No secomdary outcome |  | June 2011 - November 2013 |