linjc16/ctgov huggingface dataset:
Pulmonary Hypertension and Arrhythmia

Study Overview
=================
Brief Summary
-----------------
Patients with pulmonary hypertension underwent (routine) Holter ECG and were screened for (malignant) arrhyhtmias. Results of Holter ECGs were correlated with clinicial and technical data (echocardiography and right heart catheterization).

Official Title
-----------------
Incidence and Prognostic Significance of (Malignant) Arrhythmias During Repetitive Holter Electrocardiograms in Patients With Pulmonary Hypertension

Conditions
-----------------
Pulmonary Hypertension

Intervention / Treatment
-----------------
* Other: Holter ECG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Holter ECG - 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 |
| --- |
|Other: Holter ECG|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arrhythmias during Holter ECG | Which kind of arrhythmias could be detected during repetitive Holter ECG in patients with PH? | 1-3 day(s) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relation between arrhythmias and PH group, echocardiographic data, right heart catheterization data. |  | 1-3 day(s) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pulmonary hypertension, PH, arrhythmias, survival
Nice Morning- Safety and Efficacy Observational Study of Telmisartan in Hypertensive Patients in Multicenters

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to survey the safety and effectiveness of the product under the real condition of usual practice in Taiwanese hypertensive patients. During the 8-week observation, the safety profiles and the clinical evaluation in between doses through blood pressure (BP) measurement for overall effectiveness of telmisartan therapy will be concluded.

Official Title
-----------------
Safety and Effectiveness of Micardis Tablets Taken Once Daily at 40 mg/Day and 80 mg/Day in Hypertension Patients

Conditions
-----------------
Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Male or female. 2. Aged 20 to 80 years old. 3. Patients meet one of following two criteria: Adult essential hypertensive either newly diagnosed and untreated, or previously treated and uncontrolled patients; sitting blood pressure: systolic blood pressure (BP) > 140 mmHg but < 180 mmHg, and/or diastolic BP > 90 mmHg but < 110 mmHg). Patients who are assessed to benefit from the intake of angiotensin II receptor blocker (ARB) monotherapy or as add-on medication. Exclusion Criteria: Patients with contraindications to telmisartan use (as per the Micardis® Tablets package insert). Known hypersensitivity to the active ingredient or to any of the excipients of Micardis® Tablets. Any other clinical condition which, in the opinion of the attending physician, would not allow safe administration of the study medications.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| Percentage of Patients Achieving Blood Pressure (BP) Control | BP control was defined as diastolic blood pressure/systolic blood pressure DBP/SBP< 90/140 mm-Hg during observation period. BP is measured every four weeks. The observation period is 8 weeks. | 01-Dec-2006 to 31-Dec-2008 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Achieving BP Response | Achieving BP response was defined as reduction from baseline in sitting SBP or DBP > 10 mmHg during the observational period. The observation period is 8 weeks. | 01-Dec-2006 to 31-Dec-2008 | 
| Overall Assessment by Patients | Overall assessment was reported as a 5-point scale rated from 0 to 4 as below: 4: Outstanding 3: Very satisfactory 2: Satisfactory 1: Marginal 0: Not satisfactory | 01-Dec-2006 to 31-Dec-2008 | 
| Overall Assessment by Attending Physicians | Overall assessment was reported as a 5-point scale rated from 0 to 4 as below: 4: Outstanding 3: Very satisfactory 2: Satisfactory 1: Marginal 0: Not satisfactory | 01-Dec-2006 to 31-Dec-2008 |
Comparison of Two Treatments in Intermediate and High-risk Acute Promyelocytic Leukemia (APL) Patients to Assess Efficacy in 1st Hematological Complete Remission and Molecular Remission

Study Overview
=================
Brief Summary
-----------------
The study will compare the efficacy of the 2 treatments in intermediate and high-risk APL patients in achieving first hematological complete remission and molecular remission.

Official Title
-----------------
A Randomized Study of Two Doses Gemtuzumab Ozogamicin vs. A Two-year Maintenance With Atra Plus Chemotherapy as Post-consolidation Treatment for Intermediate and High-risk Adult Patients With Acute Promyelocytic Leukemia (Apl)

Conditions
-----------------
Leukemia, Myelocytic, Acute

Intervention / Treatment
-----------------
* Drug: gemtuzumab ozogamicin
* Drug: ATRA plus 6-MP and MTX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients with untreated newly diagnosed and genetically proven APL (leukemic cells at diagnosis with the t(15;17) and/or the PML/RARα rearrangement by RT-PCR; the presence of additional cytogenetic lesions is not considered an exclusion criterion) with intermediate and high risk disease. Male and female patients age > 18 years and < 61 years. Exclusion criteria: Low risk patients (WBC < 10 x 109/L and platelets > 40 x 109/L). Absence of PML-RAR α rearrangement in leukemic cells after successful RNA extraction and amplification of control gene. Pretreated APL.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 61 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: a<br>2 doses of gemtuzumab ozogamicn administered at monthly intervals | Drug: gemtuzumab ozogamicin<br>* 2 IV infusions 6 mg/m2 administered monthly<br>* Other names: Arm A;|
| Active Comparator: b<br>2 years maintenance therapy with intermittent ATRA plus 6-Mercaptopurine (6-MP) and methotrexate (MTX) | Drug: ATRA plus 6-MP and MTX<br>* 6-MP 50 mg/m2/day PO; MTX 15 mg/m2/q week IM; ATRA 45 mg/m2/day PO<br>* Other names: Arm B;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The study will compare the 2 treatments in intermediate and high-risk APL patients and assess their efficacy in achieving first hematological complete remission and molecular remission. |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of short and long-term toxicity of treatment, patient quality of life, and overall survival. |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oncology comparison study
Ewing Sarcoma Family of Tumors (ESFT): A 15-year Experience From a Tertiary Care Cancer Center in Upper Egypt

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to identify demographic & disease characteristics in pediatric oncology patients diagnosed with Ewing Sarcoma Family of Tumors (ESFT) & treatment outcomes in these patients.

Detailed Description
-----------------
Ewing sarcoma (ES) and peripheral primitive neuroectodermal tumor (PNET), Both entities that currently comprise the same spectrum of neoplastic diseases known as the Ewing sarcoma family of tumors (EFT), were originally described as distinct clinicopathologic entities. Primitive neuroectodermal tumors (PNETs) first described in 1918 by Stout as a malignant tumor arising from major nerve. Later, in 1921, ES was described as an undifferentiated tumor involving the diaphysis of long bones. It was also reported to arise in soft tissue (extraosseous ES). EFT is aggressive malignant small round cell tumors of bone and soft-tissue that predominantly affecting children and young adults.

Official Title
-----------------
Ewing Sarcoma Family of Tumors (ESFT): A 15-year Experience From a Tertiary Care Cancer Center in Upper Egypt

Conditions
-----------------
Soft Tissue Neoplasms, Bone Neoplasms, Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients whose age less than 19 years. Patients diagnosed with Ewing Sarcoma Family of Tumors (ESFT). Exclusion Criteria: Patients whose age more than 19 years. Patients diagnosed with other bone & soft tissue neoplasms.

Ages Eligible for Study
-----------------
Maximum Age: 19 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 |
| --- | --- | --- |
| Overall survival (OS) | Participants will be retrospectively followed forward in time from the date of initiation of treatment till death from any cause, an expected average of 5 years | From date of treatment initiation until the date of death from any cause or patients censored at last follow up, whichever came first, assessed up to 60 months | 
| Event Free Survival (EFS) | Participants will be retrospectively followed forward in time from the date of initiation of treatment till occurrence of an event from any cause (tumor progression, relapse) or death, an expected average of 5 years | From date of treatment initiation until the date of event from any cause or patients censored at last follow up, whichever came first, assessed up to 60 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ewing's sarcoma (ES), Peripheral primitive neuroectodermal tumor (PNET)
Early Detection of Head and Neck Superficial Squamous Cell Carcinoma in Patients With Esophagus Squamous Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
the investigators randomly divide the eligible objects into two groups:1. objects in this group will first receive OE endoscopy observation and subsequent white light imaging(WLI) observation during oropharynx and hypopharynx; 2. objects in this group will first receive WLI observation and subsequent OE observation during oropharynx and hypopharynx. Then, the investigators will compare the detect rate of oropharyngeal and hypopharyngeal superficial squamous cell carcinoma of two groups to find if OE endoscopy can improve the detect rate of oropharyngeal and hypopharyngeal superficial squamous cell carcinoma in esophageal cancer patients.

Official Title
-----------------
Early Detection of Oropharyngeal and Hypopharyngeal Superficial Squamous Cell Carcinoma in Patients With Esophagus Squamous Cell Carcinoma by White Light Imaging and Optical Enhancement(OE)

Conditions
-----------------
Optical Enhancement Endoscopy

Intervention / Treatment
-----------------
* Device: first OE
* Device: first WLI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: order than 18 years old Previous or current histopathological pathology confirmed the presence of esophageal squamous cell carcinoma Exclusion Criteria: Previously confirmed pharynx/oropharyngeal squamous cell carcinoma Advanced pharynx/hypopharyngeal squamous cell carcinoma Pregnant women and lactating women pharyngeal or esophageal stenosis, esophageal varices, or active digestive tract hemorrhage influence the observation or fail to obtain pathological diagnosis Previous chemotherapy or radiation therapy affected observation Not completed gastroscopy or refused to take biopsy for various reasons Mental illnesses such as anxiety and depression affect the endoscopic observation Severe systemic disease, can not tolerate gastroscopy Refusal to sign informed consent books

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: first OE<br> | Device: first OE<br>* optical enhancement(OE)，a kind of electron straining endoscopy<br>|
| Other: First WLI<br> | Device: first WLI<br>* the routine in the clinical practice<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detect rate | the detect rate of oropharyngeal and hypopharyngeal superficial squamous cell carcinoma | 12 months |
A Reverification of the Berlin Definition Plateau Criteria in Golmud

Study Overview
=================
Brief Summary
-----------------
This study is a single-center retrospective study. According to the Berlin diagnostic standard, ARDS patients admitted to the Department of severe Medicine, Golmud People's Hospital from January 2015 to june 2022 were divided into three groups: mild (142mmHg < PaO2/ FiO2 ≤ 213 mmHg), moderate (71mmHg < PaO2/ FiO2 ≤ 142mmHg) and severe (PaO2/ FiO2 ≤ 71 mmHg). The ICU mortality, 28-day mortality, non-ventilator time in ICU, ICU hospitalization time observed respectively.

Official Title
-----------------
A Reverification of the Berlin Definition Plateau Criteria in Golmud

Conditions
-----------------
Ards

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet the diagnostic criteria of ARDS Exclusion Criteria: length of stay in hospital less than 48h Data missing younger than 18 years or older than 80 years

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Plateau Criteria<br>mild ： 142mmHg < PaO2/ FiO2 ≤ 213 mmHg moderate ： 71mmHg < PaO2/ FiO2 ≤ 142mmHg severe： PaO2/ FiO2 ≤ 71 mmHg | |
| Berlin Definition<br>mild ： 200mmHg < PaO2/ FiO2 ≤ 300 mmHg moderate ： 100mmHg < PaO2/ FiO2 ≤ 200mmHg severe： PaO2/ FiO2 ≤ 100 mmHg | |
| zhang<br>ARDS：PaO2/FiO2≤100mmHg ALI ：100mmHg<PaO2/FiO2≤150mmHg | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU mortality | Mortality during treatment in ICU | up to 24 weeks | 
| 28-days mortality rate | 28-days mortality rate [ Time Frame: 28 days after discharge ] Mortality at 28 days of hospitalization | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator Free time | Ventilator Free time in ICU | up to 24 weeks | 
| Ventilator time | Ventilator time in ICU | up to 24 weeks | 
| Hospital length of stay | Hospital length of stay in hospital | up to 24 weeks |
Effects of Raltegravir (Isentress®) on Lipid and Carbohydrate Metabolism and Mitochondrial Function in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Raltegravir is the first of a new antiretroviral class. A better profile of metabolic toxicity is expected. In order to better define its effects, without interference with other drugs, a study on healthy volunteers is warranted.

Official Title
-----------------
Study on the Effects of Raltegravir (Isentress®) on Lipid and Carbohydrate Metabolism and Mitochondrial Function in Healthy Volunteers

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: raltegravir
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male. age between 18 and 45. BMI between 19 and 25 kg/m2 Normal physical exam. Blood analysis without relevant findings. Negative serology for hepatitis B, Hepatitis C and HIV. Negative urine test for abuse drugs. Exclusion Criteria: Severe psychiatric disease. Dyslipemia. Alcohol intake above 30 g per day. Smokers Xanthine intake above 5 coffee cup -equivalents per day Use of any drugs in the last month Participation in other trials in the last 3 months Diseases capable to modify drug ADME Drug allergy

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: raltegravir|raltegravir 400 mg BID for 7 days|
|Drug: Placebo|Placebo BID for 7 days|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood levels of total cholesterol |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in HDL, LDL and triglycerides |  | 7 days | 
| Oral glucose tolerance test |  | 7 days | 
| Mitochondrial DNA levels |  | 7 days |
Effects of Cox-II Inhibitor on Biochemical Markers in Cardiovascular-related Adverse Effects

Study Overview
=================
Brief Summary
-----------------
The selective cyclooxygenase-2 (COX-2) inhibitors have been associated with increased cardiovascular risk. The goal of the present study is to investigate the impacts of COX-2 inhibitors on biochemical indices in cardiovascular disease. As the reviewer suggested, the investigators propose to study the effects of Cox-II inhibitor using experimentally induced hyperlipidemic rats. Plasma total cholesterol, LDL and triglyceride concentrations will be determined before and after animals treated with cyclooxygenase-2 (COX-2) inhibitors. Biochemical markers related to cardiovascular events including prostaglandin I2, thromboxaneA2 and others will also be investigated. The investigators will also investigate these biochemical markers in patients taking Celecoxib and NSAIDs. The investigators hope these studies will reveal clinically useful biochemical markers for cardiovascular events in patients taking Cox-II inhibitor.

Conditions
-----------------
Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male/female age >18 Clinical diagnosed of arthritis Exclusion Criteria: Must not be pregnant/breastfeeding Other conditions may lead to exclusion from the trial (e.g. Diabetes mellitus, malignant melanoma, cardiac conduction disorders, hepatic/renal insufficiency.

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RA with drug<br> | |
| RA without drug<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Retrospective Evaluation of Cellulite of Laxity Treatment Using Body Tite

Study Overview
=================
Brief Summary
-----------------
Retrospective Evaluation of Cellulite of Laxity Treatment Using Body Tite

Detailed Description
-----------------
The purpose of this preliminary report is to retrospectively evaluate this novel treatment approach to improve the appearance of cellulite on the thighs and buttocks by tightening the SFS using RFAL.

Official Title
-----------------
Retrospective Evaluation of Cellulite of Laxity Treatment Using Body Tite

Conditions
-----------------
Cellulite

Intervention / Treatment
-----------------
* Device: BodyTite


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥ 18years of age at the time of procedure patients with localized lipodystrophy in the medial or lateral thigh, and visible cellulite of laxity in the lower extremity or buttocks BodyTite treatments performed from January 2018 - May 2019 for Cellulite indication Exclusion Criteria: active infection, collagen disorders, immunocompromised state, medications that mitigate inflammatory response, and propensity for keloid/hypertrophic scaring. o BodyTite treatments performed from March 2018 - May 2019 for lipodystrophy and cellulite of laxity

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: BodyTite|retrospectively evaluate this novel treatment approach to improve the appearance of cellulite on the thighs and buttocks by tightening the SFS using RFAL.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photonumeric Cellulite Severity Score | Change in Photonumeric Cellulite Severity Score 3. Investigator assessment of the cellulite improvement comparing pre and post treatment using Global aesthetic improvement 5-point grading scale (0=No change, 1=1%-24%%, 2=25%-49%, 3=50%-74% improvement, and 4=75%-100%) at all follow up visits. | [ Time Frame: Baseline to 6 months posttreatment] |