linjc16/ctgov huggingface dataset:
QT-prolongation in Psychiatric Hospitals

Study Overview
=================
Brief Summary
-----------------
Observational study in 6 psychiatric hospitals in Flanders. Patients are included when a QT-prolonging drug is added to a medication profile that already contains a potential QT-prolonging drug. An ECG is taken before the administration of the new drug and a week after starting the new drug to investigate the change in duration of the QTc-interval. Risk factors for developing QT-prolongation and blood concentrations of potassium and creatinine are documented.

Official Title
-----------------
QT-prolongation in Psychiatric Hospitals

Conditions
-----------------
QT-prolongation

Intervention / Treatment
-----------------
* Drug: drugs linked with QT-prolongation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: inpatient in one of the 6 participating psychiatric hospitals QT-prolonging drug in the medication profile and the doctor prescribes another QT-prolonging drug Exclusion Criteria: age < 18 year

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 |
| --- | --- |
| psychiatric patients treated with QT-prolonging drugs<br> | Drug: drugs linked with QT-prolongation<br>* all the drugs that are mentioned in the lists of QT-prolonging drugs of CredibleMeds (www.crediblemeds.org)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in QTc-interval (corrected for heart rate) |  | before and one week after the start of a QT-prolonging drug | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
QT-prolongation, Torsade de Pointes, drug interactions, psychiatry
Multicenter and Prospective Clinical Registry Study of Autoimmune Encephalitis in China

Study Overview
=================
Brief Summary
-----------------
In recent years, more and more previously thought to be unknown encephalitis was found to be a specific antigen associated encephalitis，but because of the lack of recognition in the clinic, usually been misdiagnosed as other causes of encephalitis. Therefore, it is urgent to establish a database of autoimmune encephalitis in Chinese population. The prospective clinical trial of atutoimmune encephalitis in China, by screening the autoimmune encephalitis associated antibody and summarizing the cases analysis, in order to provide evidence for clinical diagnosis and treatment of autoimmune encephalitis.

Conditions
-----------------
Autoimmune Encephlitis in China

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 6 months. Encephalopathy symptoms (change of mental state and consciousness level) persist for more than 24 hours; At least one or more clinical features of the followings: fever, epilepsy, focal neurological deficiency symptoms, changes in CSF(cerebrospinal fluid inflammatory), changes in EEG (electroencephalogram), radiographic abnormalities; Clinical suspected encephalitis, but conventional detected methods cannot make etiology clear. Signed the informed consent. Exclusion Criteria: Infants less than 6 months; The metabolic encephalopathy; Infectious encephalitis with clear pathogen clinically, referring the specific pathogenic microorganisms, including: bacteria, virus, fungus, parasite, spirochete and so on; Non-infectious encephalitis with clear diagnosis clinically, including: multiple sclerosis, neuromyelitis optic, acute disseminated encephalomyelitis and so on.

Ages Eligible for Study
-----------------
Minimum Age: 6 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 |
| --- | --- |
| autoimmune encephalitis<br> | |
| unknowm encephalitis<br> | |
| other encephalopathy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death |  | 30days |
Study of Hair Samples From Patients With Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of hair in the laboratory from patients with cancer may help doctors identify biomarkers related to cancer and predict how well patients will respond to treatment. PURPOSE: This laboratory study is looking at hair samples from patients with cancer.

Detailed Description
-----------------
OBJECTIVES: Determine whether layered membrane technology can quantitatively measure the expression, activity, and localization of cell growth control and signaling proteins in hair samples from patients with cancer. Correlate changes in protein expression with expected changes based on planned therapy in these patients. OUTLINE: This is a pilot, multicenter study. Hair samples are obtained from patients at baseline and at the end of study. The samples are assayed for proteins and phosphorylation status using layered membrane technology. Proteins analyzed may include vascular endothelial growth factor receptor (VEGFR), Erk1/2, Akt, epidermal growth factor receptor (EGFR), and c-KIT. PROJECTED ACCRUAL: A total of 190 patients will be accrued for this study within 3 years.

Official Title
-----------------
Detection and Quantification of Changes in Levels of Protein Expression and Phosphorylation Status Using Human Hair Samples

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

Intervention / Treatment
-----------------
* Genetic: protein expression analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of malignancy Undergoing treatment at the National Cancer Institute's Clinical Center Must have scalp hair PATIENT CHARACTERISTICS: Age 18 and over Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified

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 |
| --- |
|Genetic: protein expression analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obtain data on the detection and quantification of changes in levels of protein expression and phosphorylation status using human hair samples at baseline and after completion of study |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
unspecified adult solid tumor, protocol specific
Investigate a Interaction of Candesartan and Atorvastatin in Healthy Male Sugjects

Study Overview
=================
Brief Summary
-----------------
primary object : Evaluate pharmacokinetic drug-drug interaction of Candesartan and Atorvastatin

Conditions
-----------------
Healthy Male Subjects

Intervention / Treatment
-----------------
* Drug: Candesartan cilexetil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult healthy males 20 to 45 years at screening. BMI 18-29 kg/m2 Exclusion Criteria: History of cardiovascular, respiratory, hepatic, renal, neuropsychiatric, endocrine, hematologic disease Hypersensitivity reactions to drugs or significant hypersensitivity reactions in the history of Candesartan and Atorvastatin Hypotension (DBP ≤ 100 mmHg or SBP ≤ 95mmHg) and hypertension (SBP ≥ 150 mmHg or DBP ≥ 95 mmHg) Gastrointestinal disease affected the absorption of medications Genetic disease of Galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption AST or ALT > 2 x normal range Total bilirubin > 2.0 mg/dl CK > 2 x normal range eGFR < 60 mL/min/1.73m2 Subject who have drunken habitually (alcohol more than 21 units/week, 1 unit = 10 g = 12.5 mL of pure alcohol) or who are unable to quit drinking during this study Subject who have smoke habitually more than 10 cigarettes/day or who are unable to quit smoking during this study Subject who treated with any investigational drugs within 90 days before the administration of investigational drug Previously donate whole blood within 60 days or component blood within 30 days or transfusion within 30 days Subject who treated with any drug within 30 days can affect absorption, distribution, metabolism, excretion of candesartan or atorvastatin Subject who treated with any Rx only drug or herbal drug within 14 days and any OTC within 7 days History of drug abuse Genetic neuromuscular disorder or family history of neuromuscular disorder Unusual diet affected the absorption, distribution, metabolism, excretion of medications Subjects deemed ineligible by investigator based on other reasons

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 45 Years

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

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Candesartan cilexetil|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (Candesartan cilexetil) |  | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours | 
| Cmax (Atorvastatin) |  | 0, 0.25, 0.5, 0.75, 1, 1.333, 1.667, 2, 3, 4, 6, 8, 12, 24, 48 hours | 
| AUClast (Candesartan cilexetil) |  | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours | 
| AUClast (Atorvastatin) |  | 0, 0.25, 0.5, 0.75, 1, 1.333, 1.667, 2, 3, 4, 6, 8, 12, 24, 48 hours |
Chrysalis Day Program Body Mass Index Study

Study Overview
=================
Brief Summary
-----------------
This is a study to determine if the approach taken to treat patients in the Chrysalis Day Hospital Program will favourably effect their health status as assessed by Body Mass Index (BMI)

Detailed Description
-----------------
As part of the Providence Continuing Care Center's continuing quality improvement initiatives this study is to more systematically evaluate the success of the Chrysalis Day Hospital Program in dealing with some features of eating disorders commonly experienced by its patients. At intake all clients will be approached to give informed consent to participate. If they do consent they will have their height and weight recorded( if they request they will not be told their weight)as part of the usual intake process conducted by a dietician. When clients exit the program they again will be approached to be weighed. The body mass index will be calculated and compared to admission values. The Chrysalis Program is a unique day hospital approach to treating individuals with severe personality disorders (primarily Borderline)that views the eating disordered behaviour common to these clients as a symptom of many and by addressing core issues of affect dysregulation as well as psychoeducation about eating the eating problems will improve .

Official Title
-----------------
A Study on the Effects of a Personality Disorder Day Hospital Program on Clients Body Mass Index

Conditions
-----------------
Borderline Personality Disorder, Eating Disorders

Intervention / Treatment
-----------------
* Behavioral: Chrysalis Day Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clients of the Chrysalis Program Exclusion Criteria: clients of the Chrysalis Program who do not consent to the study

Ages Eligible for Study
-----------------
Minimum Age: 16 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

| Intervention/Treatment |
| --- |
|Behavioral: Chrysalis Day Program|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index at time of enrolling in programme and at leaving |  | at entry and upon leaving the program | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient demographics relationship to outcome |  | upon entry and exit from the program | 
| programme changes and relation to outcome |  | from start to the end of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Day hospital treatment
Use of Human Papillomavirus Persistence for Determination of Treatment Efficacy Among Women With Cervical Dysplasia

Study Overview
=================
Brief Summary
-----------------
The objectives are to evaluate the effectiveness of treatment of cervical intraepithelial neoplasia (CIN) by loop electrosurgical excision procedure using persistence of human papillomavirus (HPV) as outcome, and to perform a long-term follow-up on the ability of HPV testing, as compared to cytology, to predict recurrence of high-grade CIN.

Detailed Description
-----------------
Cervical samples for human papillomavirus (HPV) DNA analysis and cytological analysis were obtained from women with abnormal smears referred to Umeå university hospital, Sweden, for treatment with conization. These women were scheduled for HPV DNA testing and Pap smears before and 3, 6, 12, 24 and 36 months after treatment. The HPV DNA testing was performed with a PCR-based genotyping method.

Official Title
-----------------
Evaluation of the Use of Human Papillomavirus Persistence for Determination of the Treatment Efficacy Among Women With Cervical Intraepithelial Neoplasia, and for Prediction of Recurrence of Cervical Disease

Conditions
-----------------
Human Papillomavirus Infection, Cervical Intraepithelial Neoplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Referral to Umeå university hospital for treatment due to abnormal Pap smear. Exclusion Criteria: Lack of informed consent.
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
Omepral® Tablets Special Clinical Experience Investigation in Patients With Erosive Esophagitis

Study Overview
=================
Brief Summary
-----------------
This open label, non-interventional study is to compare the efficacy of Omepral® tablet and any other treatments excepting proton pump inhibitors (PPIs) for the treatment of various type of acid reflux related symptoms in patients with reflux esophagitis.

Official Title
-----------------
Omepral® Tablets Mega-study to Investigate the Efficacy on Various Type of Acid Reflux Related Symptoms and QOL, and Epidemiology in Patients With Erosive Esophagitis in Daily Medical Practice

Conditions
-----------------
Reflux Esophagitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients newly diagnosed as erosive esophagitis or history of erosive esophagitis confirmed by endoscopy. Patients who answered questionnaires of quality of life (QOLRAD-J), symptom severity and frequency and treatment satisfaction. During the past 1 week , patients who have either two days or more with heartburn or acid taste in the mouth of any severity Exclusion Criteria: Patients receiving treatment with proton pump inhibitors, which make stomach acid decreased during the last 4 weeks prior to enrolment. Patients who cannot answer questionnaires of quality of life (QOLRAD-J), symptom severity and frequency and treatment satisfaction. Patients included previously in this study.
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 |
| --- | --- | --- |
| Patients symptom evaluated by investigator |  | at entry, 4 weeks and 8 weeks | 
| Patients reported symptom |  | at entry, 4 weeks and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients reported outcome score |  | at entry, 4 weeks and 8 weeks | 
| Adverse event |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Reflux esophagitis, Omepral®, QOLRAD
CT Virtual Proctoscopy for Staging and Volume Assessment for Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see how CT virtual proctoscopy compares to an ultrasound exam of the rectal area in determining the stage of rectal cancer for people recently diagnosed with rectal cancer. This study will also compare tumor volume before and after neoadjuvant therapy using CT virtual proctoscopy, with the ultrasound exam as a comparison. Neoadjuvant therapy consists of chemotherapy and radiation therapy. Neoadjuvant chemoradiation therapy is done before surgery to reduce the size of tumors.

Official Title
-----------------
CT Virtual Proctoscopy for Staging and Volume Assessment for Rectal Cancer

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Procedure: CT Virtual Proctoscopy (CTVP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have been diagnosed with adenocarcinoma of the rectum, who have not started their neoadjuvant treatment yet. Exclusion Criteria: Patients who have started their neoadjuvant therapy already

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 |
| --- | --- |
| Other: 1<br>CT virtual proctoscopy | Procedure: CT Virtual Proctoscopy (CTVP)<br>* CTVP done prior to initiation of therapy and a couple of weeks before patient has surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The utility of CT virtual proctoscopy (CTVP) for evaluation of rectal cancer. |  | 3 months |
Intraoperative Transfusion Practice in Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine factors, impact and outcome on perioperative blood transfusion for pediatric patients.

Official Title
-----------------
A Retrospective Analysis of Perioperative Transfusion Management in Children

Conditions
-----------------
Transfusion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Operation Anaesthesia Transfusion (pRBC, plasma or platelets) Exclusion Criteria: No

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 17 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 |
| --- | --- | --- |
| Number of children being transfused intraoperative | Amount of transfused pRBC, plasma, thrombocytes will be evaluated in children undergoing surgery | 01.04.2018 to 31.10.2019 | 
| Documented transfusion indication | Physiologic transfusion triggers will be evaluated (Hb Level, lactate, venous O2 saturation, levels of catecholamines) | 01.04.2018 to 31.10.2019 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transfusion, Pediatric, Patient Blood Management
Bioequivalence Study Between Two Oral Formulations of Famotidine Tablets Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
Compare the rate and extent of absorption of famotidine 40 mg tablets, administered as 1 x 40 mg tablet under fasting conditions.

Official Title
-----------------
Randomized, 2-Way Crossover, Bioequivalence Study of Famotidine 40 mg Tablets Administered as 1 x 40 mg Tablet in Healthy Subjects Under Fasting Conditions

Conditions
-----------------
Bioavailability

Intervention / Treatment
-----------------
* Drug: Famotidine Tablets, 40 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy men or women 18 years of age or older body mass index below 30.0 kg/m2 willing to participate and sin a copy of the informed consent form Exclusion Criteria: recent history of drug or alcohol addiction or abuse pregnant or lactating women history of allergic response to heparin, famotidine, other H2-receptor antagonists, or other related drugs evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant recipient of any drugs as part of a research study within 30 days prior to study dosing

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Test Product<br> | Drug: Famotidine Tablets, 40 mg<br> <br> |
| Active Comparator: Reference Product<br> | Drug: Famotidine Tablets, 40 mg<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence was assessed based on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bioavailability, famotidine