linjc16/ctgov huggingface dataset:
Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
This is an open-label Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of GDC-0919, an investigational agent intended to inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme and help the human immune system attack solid tumor cells more effectively.

Official Title
-----------------
A Phase I Study of GDC-0919 for Adult Patients With Recurrent Advanced Solid Tumors

Conditions
-----------------
Solid Tumor

Intervention / Treatment
-----------------
* Drug: GDC-0919


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed solid tumor that is relapsed/refractory to standard therapies or for which no approved or curative therapy exists Age > or = 18 Eastern Cooperative Oncology Group (ECOG) performance status < 2 Life expectancy > or = 12 weeks Adequate hematologic and organ function before initiation of GDC-0919 For some patients only: Accessible lesions amenable to paired fresh tumor biopsies Exclusion Criteria: Some prior cancer immunotherapies Untreated brain metastases Active or history of autoimmune 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: GDC-0919 Dose Escalation<br>GDC-0919 to be given on an outpatient basis as a single agent. Starting dose of GDC-0919 will be 50 mg by mouth every 12 hour. Patients will receive the study drug daily for 21 days followed by 7 days off for a cycle length of 28 days; or on 28 consecutive days of a 28-day cycle | Drug: GDC-0919<br>* Supplied in 50 mg and 200 mg capsules. To be taken every 12 hours with water by mouth on an empty stomach (no food or drink other than water for 2 hours prior to dose). Taken twice daily for 21 days each cycle, followed by 7 days off; or taken twice daily on 28 consecutive days of a 28-day cycle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with dose-limiting toxicities |  | 28 days | 
| Number of dose-limiting toxicities |  | 28 days | 
| Percentage of patients with adverse events |  | approximately 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Serum concentrations (Cmax/Steady State) |  | 21 days |
Impact of Three Different Gonadotrophin Regimes on Egg Donation Program

Study Overview
=================
Brief Summary
-----------------
Exploratory study assessing the effect of three gonadotrophin protocols on Controlled Ovarian Stimulation (COS) parameters and IVF outcome in oocyte donors undergoing GnRH analogue (long protocol). 1,028 donors were randomized in three groups: Group I (n= 346) only r-FSH, Group II (n= 333) only HP-hMG and Group III (n= 349) r-FSH plus HP-hMG. IVF outcome of 1,059 oocyte recipients was compared.

Official Title
-----------------
A Prospective, Randomized, Controlled Trial Comparing Three Different Gonadotrophin Regimens in Oocyte Donors: Ovarian Response and IVF Outcome

Conditions
-----------------
Ovarian Stimulation

Intervention / Treatment
-----------------
* Drug: r-FSH
* Drug: HP-hMG
* Drug: r-FSH plus HP-hMG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy women 18-34 years of age regular menstrual cycles no family history of hereditary or chromosomal diseases normal karyotype BMI 18-29 Kg/m2 negative screening for sexually transmitted diseases Exclusion Criteria: women with PCOS were not included in this study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 34 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I<br>only r-FSH TREATMENT | Drug: r-FSH<br> <br> |
| Experimental: II<br>only HP-hMG TREATMENT | Drug: HP-hMG<br> <br> |
| Experimental: III<br>r-FSH plus HP-hMG TREATMENT | Drug: r-FSH plus HP-hMG<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The aim of this study was to verify whether different gonadotrophin regimes could affect controlled ovarian stimulation (COS) parameters and IVF outcome in an egg donation program. |  | one year |
Prevalence of Occult HBV Infection Among Anti-HBc Alone Group in Northern Taiwan

Study Overview
=================
Brief Summary
-----------------
Atni-HBs to HBsAg and Anit-HBc was interpreted based on three hepatitis markers for clinical detection of HBV-infections. HBAg and Anti-HBs were negative and the Anit-HBc-positive referred to as Anti-HBc alone. When the Anti-HBc alone occurs, patients may be due to mutations in HBV HBsAg can not be detected due to (1), but if by the molecular diagnostics by polymerase chain reaction (PCR) technology can detect HBV DNA present. When Anti-HBc alone in patients with serum HBV DNA can be measured, then there may be occult HBV infection. In different countries, Occult HBV infection in the Anti-HBc Alone group had significant differences in the prevalence (2.9   22.8%) (2), but prevalence survey in Taiwan there are very few studies on this , It is hoped to be able to investigation the prevalence of occult HBV infection Among Anti-HBc Alone.

Detailed Description
-----------------
The main use of this program, Taipei Medical University - Wan Fang Hospital in clinical specimens using the Roche system (Corbas e601) operating HBsAg, Anti-HBs, Anti-HBc to screen for the Anti-HBc alone group. Recycling Roche molecular system (Taq48) Real-time PCR to detect all anti-HBc alone population to understand their serum HBV-DNA viral load, in order to understand Occult HBV infection in the Anti-HBc alone group, the prevalence and viral load changes in these studies through the clinical units to provide occult HBV infection as a reference basis.

Official Title
-----------------
Prevalence of Occult HBV Infection Among Anti-HBc Alone Group in Northern Taiwan

Conditions
-----------------
HBV Coinfection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HBsAg(-)；Anti-HBs(-)；Anti-HBc(+) Exclusion Criteria: None
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anti-HBc alone ；occult HBV infection
Pharmacokinetics and Drug Interaction Study Between Amlodipine,Olmesartan and Rosuvastatin in Healthy Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between amlodipine, olmesartan and rosuvastatin in healthy adult volunteers.

Official Title
-----------------
An Open Label, Randomized, 2-Sequence, Multiple-Dose, Cross-Over Study to Investigate the Drug-Drug Interaction of Sevikar and Crestor in Healthy Adult Volunteers

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

Intervention / Treatment
-----------------
* Drug: Sevikar(amlodipne/olmesartan)
* Drug: crestor(Rosuvastatin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects aged 19 - 55 years A body mass index in the range 19 - 27 kg/m2 Willingness to participate during the entire study period Written informed consent after being fully informed about the study procedures Exclusion Criteria: Any past medical history of hepatic, renal, gastrointestinal, respiratory, endocrine, psychiatric, neurologic, haemato-oncologic or cardiovascular disease History of clinically significant drug hypersensitivity Use of medication within 7 days before the first dose Heavy drinker (>140 g/week) Whole blood donation during 60 days before the study Judged not eligible for study participation by investigator

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment AB<br>S->S+C | Drug: Sevikar(amlodipne/olmesartan)<br>* Treatment AB<br>Drug: crestor(Rosuvastatin)<br>* Treatment AB/Treatment C<br>|
| Experimental: Treatment C<br>C | Drug: crestor(Rosuvastatin)<br>* Treatment AB/Treatment C<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCtau |  | Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment | 
| Css,max |  | Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tss,max |  | Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment | 
| Css,min |  | Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment |
Effectiveness of Osteopathic Manipulative Treatment in Pediatric Asthma

Study Overview
=================
Brief Summary
-----------------
Asthma is a highly prevalent chronic disease in children. Complementary and Alternative Medicine research on asthma showed a potential effect on pediatric patients. Studies looking at the effect of Osteopathic Manipulative Treatment seems to reveal positive results. The aim of study is to further explore the role of OMT on asthma in a pediatric population.

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Other: OMT + Usual Care
* Other: Usual Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children with asthma age between 5 and 14 Exclusion Criteria: associated co-morbities surgical patients

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 14 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: OMT + Usual Care<br> | Other: OMT + Usual Care<br>* patients from this group received 6 sessions of OMT<br>|
| Other: Usual Care<br> | Other: Usual Care<br>* patients from control group received standard care + osteopathic evaluation only, according to the same schedule of the study group<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Forced expiratory volume in the 1st second (FEV1) before and after OMT |  | Participants will be assessed at entry, after 3 and 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in fractional exhaled nitric oxide (FeNO) before and after OMT |  | Participants will be assessed at entry, after 3 and 6 months. | 
| Difference in percentage of hemoglobin saturation before and after OMT |  | Participants will be assessed at entry, after 3 and 6 months. | 
| Difference in Pediatric Asthma Quality of Life Questionnaire (PAQOL) before and after OMT |  | Participants will be assessed at entry, after 3 and 6 months. | 
| Differences in the number, type and quality of somatic dysfunctions |  | Participants will be assessed at entry, after 3 and 6 months | 
| Difference in peak expiratory flow (PEF) before and after OMT |  | Participants will be assessed at entry, after 3 and 6 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatrics, asthma, osteopathic manipulative treatment
Hypoperfusion-hypodensity Mismatch for the Identification of Patients With Stroke Within 4.5 Hours

Study Overview
=================
Brief Summary
-----------------
Intravenous thrombolysis is recommended within 4.5 hours of stroke onset. The aim of the study is to evaluate whether a hypodensity on native CT within the virtually entire area of hypoperfusion on perfusion CT, i.e. hypoperfusion-hypodensity mismatch, identifies patients within the time window of thrombolysis in a multicenter cohort. The investigators hypothesize hypoperfusion-hypodensity mismatch will identify patients ≤ 4,5 hours of symptom onset with >70% specificity and >85% positive predictive value.

Official Title
-----------------
Mismatch Between Hypoperfusion and Hypodensity on CT for the Identification of Patients With Stroke Onset Within 4.5 Hours

Conditions
-----------------
Acute Ischemic Stroke

Intervention / Treatment
-----------------
* Diagnostic Test: hypoperfusion-hypodensity mismatch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute ischemic stroke evidence of acute intracranial vessel occlusion (any supratentorial proximal or peripheral artery of the anterior cerebral artery, middle cerebral artery or posterior cerebral artery territory) by CT hyper dense thrombus and/or CTangiography vessel occlusion and/or by ischemic perfusion deficit evidence for acute ischemic perfusion deficit, i.e. acute symptoms attributable to ischemic CT perfusion lesion complete native CT and CTperfusion performed on admission sufficient CT and CTperfusion quality for judgement of acute ischemic hypodensity known time of symptom onset. Exclusion Criteria: None

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: hypoperfusion-hypodensity mismatch|hypoperfusion-hypodensity mismatch on computed tomography|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive predictive value of hypoperfusion hypodensity mismatch for the identification of patients ≤4.5 hours |  | on admission | 
| Specificity of hypoperfusion hypodensity mismatch for the identification of patients ≤4.5 hours |  | on admission |
Psychiatric Co-morbidities and Socio-demographic Characteristics in Patients With Idiopathic Hypersomnia

Study Overview
=================
Brief Summary
-----------------
This is a study of only patients with idiopathic hypersomnia. It is a rare and still poorly understood pathology. In clinical practice, we have found that the treatment and care offered were not always effective. The idea of this study to improve knowledge of this pathology by studying the demographic characteristics of patients and other co-morbidities, in particular psychiatric patients, to see if we can identify common factor to our patients and useful in their medical care. The main objective of this research is to allow a quantitative study of the demographic and psychiatric characteristics of patients with idiopathic hypersomnia.

Official Title
-----------------
Psychiatric Co-morbidities (Seasonal Affective Disorder and Bipolar Disorder) and Socio-demographic Characteristics in Patients With Idiopathic Hypersomnia: Quantitative Study Following 48-hour Polysomnographic Recordings.

Conditions
-----------------
Idiopathic Hypersomnia, Mood Disorder, Bipolar Disorder

Intervention / Treatment
-----------------
* Other: respond to questionnaires by telephone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients with a diagnosis of idiopathic hypersomnia according to the ICSD 3 criteria and the performance of a 48-hour polysomnography at the Sleep Laboratory, between 2004 and today. Exclusion Criteria: minors persons and under legal protection persons.

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 |
| --- | --- |
| adult patients with a diagnosis of idiopathic hypersomnia<br>adult patients with a diagnosis of idiopathic hypersomnia according to the International Classification of Sleep Disorders (ICSD 3) criteria and the performance of a 48-hour polysomnography at the Sleep Laboratory, between 2004 and today. | Other: respond to questionnaires by telephone<br>* Seasonal Pattern Assessment Questionnaire (SPAQ) questionnaires and Sachs bipolarity index and Idiopathic Hypersomnia (IH) severity score<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| demographic characteristics | SPAQ questionnaires | day 1 | 
| psychiatric characteristics | SACHS bipolarity index | day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
demographic characteristic, psychiatric morbidity
The Genetics of Diabetes in Southern California Chinese Americans

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to investigate the genetic causes of diabetes. Specifically, we are interested in the mitochondrial genome and how variants in the mitochondrial genome influence a person's risk to develop diabetes and metabolic syndrome.

Detailed Description
-----------------
Since our laboratory's initial linkage of Type 2 diabetes to a mtDNA rearrangement in a three generation maternal pedigree 13 years ago, there has been increasing support for our hypothesis that mitochondrial dysfunction plays an important role in the etiology of Type 2 Diabetes Mellitus (DM) and the overlapping Metabolic Syndrome (MS). With this study we are planning an extensive investigation of defects in mitochondrial oxidative phosphorylation (OXPHOS) caused potentially by deleterious sequence variants in the mitochondrial DNA (mtDNA). As the primary objective we are trying to further substantiate 2 hypotheses: 1) that these diabetogenic mtDNA variants, which are proposed to range from recent, relatively severe, mutations will result in substantial OXPHOS defects with familial DM & MS and 2) that ancient, relatively mild polymorphisms result in partial OXPHOS defects and an increase in the risk to develop DM & MS.

Official Title
-----------------
Mitochondria and Metabolic Syndrome in a Southern California Chinese Cohort

Conditions
-----------------
Type 1 Diabetes, Type 2 Diabetes, Metabolic Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chinese or Taiwanese ancestry Resident of Southern California Age between 40 and 65 Both people with and without diabetes are welcome to enroll. Exclusion Criteria: Younger than 40 years or older than 65 years Ancestry is not Chinese or Taiwanese Not a resident of Southern California

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

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 |
| --- | --- |
| 1<br>Individuals with diabetes | |
| 2<br>Individuals without diabetes | |

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
-----------------
diabetes, type 1, type 2, metabolic syndrome, mitochondria
Social Media Use During COVID-19

Study Overview
=================
Brief Summary
-----------------
The investigators plan to conduct a cross-sectional survey to examine how social media use during COVID-19 relates to: (1) information management, (2) assessment of the situation, and (3) affect.

Official Title
-----------------
Getting it Right: Towards Responsible Social Media Use During a Pandemic

Conditions
-----------------
Coronavirus, Depression, Anxiety, Stress

Intervention / Treatment
-----------------
* Behavioral: Use of social media during COVID-19


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 21 years Has stayed in Singapore for at least 2 years Exclusion Criteria: Below 21 years Has stayed in Singapore for less than 2 years

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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 |
| --- | --- |
| Community sample<br>We plan to recruit a representative sample of the Singapore population. | Behavioral: Use of social media during COVID-19<br>* Participants' self-reported use of an official WhatsApp channel to receive and share news about COVID-19<br>* Other names: WhatsApp;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression, Anxiety and Stress Scale | 21-item validated scale assessing symptoms of depression, anxiety, and stress (DASS-21): Min score = 0, Max score = 21; higher score indicates a worse outcome | Single measurement (upon study enrolment) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Social media, Communication