linjc16/ctgov huggingface dataset:
A Study to Evaluate the Clinical Epidemiology of Patients With Heart Failure (HF) in India

Study Overview
=================
Brief Summary
-----------------
This non-interventional, prospective, multi-centric, cross-sectional study is aimed to observe clinical practice in India in managing Heart Failure patients & to check one year outcome in HF patients. A total of 5 visits will be conducted during the study. There will be a baseline visit followed by four follow-up visits to assess the outcomes

Detailed Description
-----------------
A non-interventional, prospective study to evaluate the clinical epidemiology of patients with Heart Failure (HF) in India

Official Title
-----------------
A Non-interventional, Prospective Study to Evaluate the Clinical Epidemiology of Patients With Heart Failure (HF) in India

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of subject informed consent Female or male aged 18 years and over All patients with Dyspnea and/or signs of systemic congestion Exclusion Criteria: Subjects with Current Acute Coronary Syndrome Absence of cardiac disease/structural heart 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular hospitalization rates and Length of stay |  | 1 year | 
| HF related Hospitalization and hospital visits |  | 1 year | 
| Cardiovascular and all cause mortality |  | 1 year | 
| Change in Minnesota Living with Heart Failure Questionnaire scores. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Failure, Cardiovascular disease, Congestive Heart Failure
rTMS in Facilitation of Working Memory in PD

Study Overview
=================
Brief Summary
-----------------
Ten sessions of repetitive transcranial magnetic stimulation yield ability to upregulate the function of primary motor cortex and prefrontal cortex that play key roles in motor and frontal memory processing.

Detailed Description
-----------------
Excitatory (>3Hz) rTMS could facilitate the brain cortex and neuroplasticity that benefits motor control and working memory when the coil is applied over primary motor cortex or dorsolateral prefrontal cortex.

Official Title
-----------------
rTMS in Facilitation of Working Memory in PD

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Device: rTMS
* Behavioral: Cognitive training program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Parkinson's Disease With symptoms of cognitive impairments, such as memory, attention, or language decline. Exclusion Criteria: History of seizure attack Alzheimer's disease With cardiac pacemaker implantation

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 85 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
Interventional Model Description: Real rTMS, sham rTMS
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High frequency rTMS<br>Real rTMS, one session per day, for 10 days | Device: rTMS<br>* High frequency rTMS for 3 to 10 min to increase the excitability of cortex.<br>|
| Experimental: High frequency rTMS with cognitive training<br>Real rTMS and cognitive training, one session per day, for 10 days | Device: rTMS<br>* High frequency rTMS for 3 to 10 min to increase the excitability of cortex.<br>Behavioral: Cognitive training program<br>* A rehabilitation protocol that facilitates attention, memory, execution.<br>|
| Sham Comparator: Sham rTMS<br>Sham rTMS, one session per day, for 10 days | Device: rTMS<br>* High frequency rTMS for 3 to 10 min to increase the excitability of cortex.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Repeatable Battery for the Assessment of Neuropsychological Status | This battery measures the cognitive functions including attention, memory, language, visuospatial domains. | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Montreal Cognitive Assessment ; MoCA | Assessing cognitive function including delaying recall, attention, executive function, language... | up to 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
working memory, parkinson's disease, cognition, rTMS
the Association Between Blood's and Urinary Heavy Metal Level in Pregnant Women and the Spontaneous Abortion

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to define the possible association between heavy iron level and the consequence of pregnancy especially spontaneous abortion and missed abortion. The study population will comprised the first-trimester pregnant women in the PUMCH (Peking Union Medicine College Hospital) during 2017 October to 2018 November. We categorised the patients into two groups, the study group where the patients suffered from spontaneous abortion or missed abortion, and the control group where the patients carry the normal live fetal for at least 8 weeks and ask for artificial abortion. All the cases included in the study were examined with respect to 6 kinds of heavy iron level in venous blood and urine, then correlation analysis was applied to define heavy iron level between two groups.

Official Title
-----------------
Department of Gynecology and Obstetrics From Peking Union Medical College Hospital

Conditions
-----------------
Heavy Metal Toxicity, Spontaneous Abortion

Intervention / Treatment
-----------------
* Other: observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - early trimester pregnant women Exclusion Criteria: -
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SG<br>Study Group is the group where the patients during observation suffer from spontaneous abortion or missed abortion, | Other: observation<br>* after the subjects are included into the groups,they are asked to do a questionaire.Then,we just observe the outcomes of pregnancy<br>|
| CG<br>Control Group is where the patients carry the normal live fetal for at least 8 weeks | Other: observation<br>* after the subjects are included into the groups,they are asked to do a questionaire.Then,we just observe the outcomes of pregnancy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood's and urinary heavy metal level | 6 kinds of heavy metal:Pb,As,Hg,Gd,Cr,Se | 12months |
Long-term Outcome of Zonal Outer Retinopathy in Punctate Inner Choroidopathy or Multifocal Choroiditis

Study Overview
=================
Brief Summary
-----------------
To report the long term prognosis in patients with punctate inner choroidopathy (PIC) or multifocal choroiditis (MFC) and associated zonal outer retinopathy (ZOR).

Official Title
-----------------
Long-term Outcome of Punctate Inner Choroidopathy or Multifocal Choroiditis With Active Choroidal Neovascularization Managed With Anti-vascular Endothelial Growth Factor

Conditions
-----------------
Punctate Inner Choroidopathy

Intervention / Treatment
-----------------
* Drug: Bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with punctate inner choroidopathy (PIC) or multifocal choroiditis (MFC) and associated zonal outer retinopathy (ZOR). Follow up over 4 years. Exclusion Criteria: Patients with punctate inner choroidopathy (PIC) or multifocal choroiditis (MFC) without zonal outer retinopathy (ZOR).

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bevacizumab|Anti-vascular endothelial growth factor (VEGF)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wilcoxon Signed-Rank test | A statistical comparison of average of different time point | Baseline, 4 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity | visual acuity change in logMAR in different time point | Baseline, 6 month, 12 month, 24 month, 36 month, 48 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
punctate inner choroidopathy, multifocal choroiditis, zonal outer retinopathy, long-term outcome
Functional Electrical Stimulation of Peripheral Muscles in Heart Failure With Preserved Left Ventricular Ejection Fraction

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of functional electrical stimulation of peripheral muscles on clinical and emotional status, endothelial function and left ventricular diastolic function in heart failure with preserved left ventricular ejection fraction.

Conditions
-----------------
Heart Failure With Preserved Left Ventricular Ejection Fraction

Intervention / Treatment
-----------------
* Other: Functional electrical stimulation of peripheral muscles


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (i) symptoms [New York Heart Association (NYHA) class II or III] and signs typical of heart failure (ii) left ventricular (LV) ejection fraction (LVEF) >50% and LV end-diastolic volume index <97 mL/m2 (iii) findings of left atrial (LA) dilatation (LA volume index >40mL/m2), LV hypertrophy and/or LV diastolic dysfunction [ie, mitral E/A ratio <1 or >2, mitral E/e' ratio >15 or 8-15, (A pulmonary - A mitral) duration difference >30 ms etc) (iv) no alterations in medical therapy during the previous 4 weeks (v) no myocardial infarction within 3 months prior to enrollment Exclusion Criteria: recent (≤4 weeks) heart failure decompensation acute coronary syndrome chronic inflammatory diseases and malignancies

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Functional electrical stimulation<br>Functional electrical stimulation of lower limbs | Other: Functional electrical stimulation of peripheral muscles<br> <br> |
| Placebo Comparator: Placebo<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise capacity |  | Six weeks | 
| Quality of life |  | Six weeks | 
| Emotional status |  | Six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular diastolic function |  | Six weeks | 
| Endothelial function |  | Six weeks |
Long-Term Open-Label Extension Trial for Subjects Completing the Phase 3 Trial of Fesoterodine (SP584) for the Treatment of Overactive Bladder Syndrome

Study Overview
=================
Brief Summary
-----------------
This trial will provide long-term data on safety, satisfaction and maintenance on therapy of fesoterodine (SPM 907) in subjects with overactive bladder syndrome. Subjects completing the 12 week treatment period of SP584 had the opportunity to participate if eligibility was confirmed. They received fesoterodine 8mg with the option to reduce the dose to 4mg during scheduled visits, and to increase again to 8mg, a procedure which can be followed on an annual basis. The primary variables are long-term safety and tolerability, measured by observation and assessment of adverse events and duration on therapy. Further safety variables include the assessment of laboratory parameters, changes in ECG, physical exams and measurement of residual urine. Secondary efficacy variables included various parameters derived from micturition diaries and the evaluation of Quality of Life questionnaires

Official Title
-----------------
Long-Term Open-Label Extension Trial for Subjects Completing the Phase 3 Trial of Fesoterodine (SP584) for the Treatment of Overactive Bladder Syndrome

Conditions
-----------------
Overactive Bladder Syndrome

Intervention / Treatment
-----------------
* Drug: SPM 907


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Overactive Bladder Syndrome

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SPM 907|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
PRoMOTE Follow-up Observational Study

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is: To evaluate the Heart Failure Risk Status (HFRS) feature performance. To establish the feasibility of remote follow-up in which patient risk triaging is performed by nurse-led review of HFRS feature as supplemental information.

Official Title
-----------------
Patient Risk Triage in ICD Remote Follow-up Observational Study (PRoMOTE FU)

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: Implantable Cardiac Defibrillator, Cardiac Resynchronization Therapy Defibrillator/Pacemaker


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients that meet all of following criteria could be included in the study: Implant of a commercially available Medtronic CRTD or ICD device with or without the Optivol Fluid Status Monitoring feature. Inclusion in the Medtronic Carelink Network. Local consent available for CL network as well as general local consent available for the use of data in observational studies signed and informative sheet delivered. Exclusion Criteria: Patients under the age of 18 years.

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 |
| --- |
|Device: Implantable Cardiac Defibrillator, Cardiac Resynchronization Therapy Defibrillator/Pacemaker|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Data collected through the phone call to the patients during the 6 months of study duration will be correlated to the HF risk classification provided by the HFRS feature on each transmission. |  | 6 months |
Meperidine for Patients Expected to Have Poor Tolerance During Diagnostic Esophagogastroduodenoscopy.

Study Overview
=================
Brief Summary
-----------------
Our pilot results showed that meperidine reduce patient discomfort during EGD (esophagogastroduodenoscopy). But many patients can tolerate EGD well without any sedative agents. So the investigators target the use of meperidine on patients expected to have poor tolerance in this study, which includ young females with high anxiety level and patients with prior poor tolerance. The investigators test the hypothesis that meperidine improves tolerance and alleviates discomfort for patients expected to have poor tolerance during diagnostic EGD.

Official Title
-----------------
Meperidine as the Single Sedative Agent for Patients Expected to Have Poor Tolerance During Diagnostic Esophagogastroduodenoscopy.

Conditions
-----------------
Patients Undergoing Diagnostic EGD

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female youger than 65 years with high anxiety level patients with previous poor tolerance of EGD Exclusion Criteria: a therapeutic EGD sedation with other agents contraindication to Buscopan (hyoscine N-butylbromide) or meperidine American Society of Anesthesiology (ASA) risk Class 3 or higher, renal failure age less than 20 years or more than 80 years pregnancy refusal to provide written informed consent. All participants signed written informed consents

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>1 ml normal saline will be given 5 minutes before EGD | Drug: placebo<br> <br> |
| Active Comparator: meperidine<br>25 mg intramuscular meperidine will be given 5 minutes before EGD | Drug: Meperidine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| discomfort score during esophageal intubation | self-reported discomfort score during esophageal intubation, assessed with a 0 to 10 (0 = none; 10 = unbearable) visual analog scale (VAS). | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient discomfort score during the procedure |  | 10 minutes | 
| patients satisfaction score |  | 10 minutes | 
| patient tolerance score evaluated by the endoscopist |  | 10 minutes | 
| endoscopist satisfaction score |  | 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EGD, tolerance, discomfort
Investigation of Chronic Inflammatory Processes in Male Individuals With Hypohidrotic Ectodermal Dysplasia

Study Overview
=================
Brief Summary
-----------------
X-linked hypohidrotic ectodermal dysplasia (XLHED) is a complex genetic disorder characterized by lack of sweat, sebaceous, submucous, Meibomian and mammary glands, sparse hair and eyebrows, and oligodontia. Insufficient function of the respective glands may lead to chronic inflammatory processes in airways and eyes of the affected individuals. The investigators will quantify sweat glands of XLHED patients, assess chronic conjunctivitis and blepharitis in conjunction with quantitative and/or qualitative alterations of lacrimal fluid in these subjects, evaluate lung function and assess chronic inflammatory processes in the airways by NO measurements. The data should provide a basis for genotype-phenotype correlations.

Official Title
-----------------
Investigation of Chronic Inflammatory Processes in the Respiratory Tract and the Eyes of Male Individuals With X-linked Hypohidrotic Ectodermal Dysplasia

Conditions
-----------------
X-linked Hypohidrotic Ectodermal Dysplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: for patients: X-linked hypohidrotic ectodermal dysplasia caused by mutations in the gene EDA written informed consent Exclusion Criteria: acute respiratory disease acute allergic problem, e.g. allergic coryza implantable electronic devices, e.g. pacemaker

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 60 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 |
| --- | --- |
| XLHED children<br> | |
| XLHED adults<br> | |
| Control children<br> | |
| Control adults<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Pediatric Enhanced Recovery After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Identify our institution's current perioperative management strategies for pediatric cardiac surgery patients. Identify predictive factors for receiving perioperative care following P-ERACS strategies. Compare outcomes between P-ERACS and non-P-ERACS patients

Detailed Description
-----------------
study aims to 1) assess our institution's current perioperative management strategies for pediatric cardiac surgery patients, 2) identify which patient population would be appropriate for inclusion in a pediatric ERACS (P-ERACS) program, and 3) compare the outcomes of patients whose perioperative care followed general consensus P-ERACS strategies (P-ERACS patients) and those whose perioperative care did not (non-P-ERACS patients). Results from this study will inform current efforts to establish a local P-ERACS protocol, and facilitate the initiation of a clinical trial to assess adherence to a P-ERACS pathway as well as the impact of such a pathway on patient outcomes.

Official Title
-----------------
Pediatric Enhanced Recovery After Cardiac Surgery: a Single-centre Retrospective Study

Conditions
-----------------
ERAS, Pediatric ALL, Congenital Heart Disease

Intervention / Treatment
-----------------
* Procedure: enhanced recovery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all pediatric patients (&lt;18 years of age) who underwent elective cardiac surgery requiring cardiopulmonary bypass (CPB) Exclusion Criteria: Emergency procedures and transplantation (heart, lung, heart and lung)

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: enhanced recovery|bundle of factors that have been shown to help with recovery in other surgical services such as good pain control, early ambulation, early nutrition|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to extubation | time to extubation | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | LOS in ICU | 48 hours |