linjc16/ctgov huggingface dataset:
a Non-interventional Study of Sildenafil in the Treatment of Pulmonary Arterial Hypertension (PAH) in Adults From China

Study Overview
=================
Brief Summary
-----------------
This observational study will involve analysis of data collected by the National Rare Disease Registry or medical records .The study will describe outcomes only in PAH(Pulmonary arterial hypertension) patients treated with sildenafil; there will be no comparison with another treatment group. Approximately 100 adults with PAH will be recruited in China hospitals This NIS(non-interventional study) data will be recorded by a physician in the medical records, during the patients' clinical visits, and in the electronic Case Report Forms (CRF).

Official Title
-----------------
A Non-interventional Study to Further Characterize the Safety and Effectiveness of Sildenafil in the Treatment of Pulmonary Arterial Hypertension (PAH) in Adults From China in a Real World Setting

Conditions
-----------------
Pulmonary Arterial Hypertension (PAH)

Intervention / Treatment
-----------------
* Other: as per Physician's prescription


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age at study index date; (The index date (i.e., Day 1 of the study) is the date when the first sildenafil dose was actually taken, after Revatio® is approved by China authority) A diagnosis of PAH with a mean pulmonary artery pressure of ≥25 mmHg and a mean pulmonary capillary wedge pressure of ≤15 mmHg by right heart catheterization; Initiated sildenafil for the treatment of their PAH based on treatment suggestion from physician ;(Patients who have received sildenafil or are receiving sildenafil are eligible to participate in this study if they met the above inclusion criteria and were ready to start sildenafil (Revatio®) for treatment at screening;) Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Exclusion Criteria: No

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: as per Physician's prescription|Participants need to take the Revatio as per Physician's prescription|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-emergent Adverse Events (TEAEs) | Incidence of TEAEs and the type of TEAEs | From baseline to week24 | 
| Serious adverse events (SAEs) | Incidence of SAE and the type of SAE | From baseline to week24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-MWD (6-minute walk distance) | Change in 6-minute walk distance (6-MWD) | baseline, week 12, week24 |
Derivation of Induced Pluripotent Stem Cells From an Existing Collection of Human Somatic Cells

Study Overview
=================
Brief Summary
-----------------
Induced pluripotent stem cells potentially may be useful in the future as an unlimited source of cells for transplantation. The major goal of the project is to develop human iPS cells from various types of cell cultures or lines from existing collections. The IPS cells will be developed for modeling diseases, for developing the technology that may eventually allow the use of IPS cells for transplantation therapy, and for basic research.

Detailed Description
-----------------
The potential to reprogram somatic cells into an embryonic state raises multiple basic research questions related both to the process of reprogramming and the properties of iPS cells. We will use various approaches to study the molecular mechanisms and processes that occur during reprogramming. We will use various experimental systems to characterize and study the properties of the iPS cells, their biology, developmental potential, capability to give rise to functional differentiated progeny etc. We will induce the differentiation of the iPS cells towards specific cell lineages and the progeny can be used to study the pathogenesis of diseases. They will be used for developing new therapeutic approaches and for high throughput screening of factors for potential toxic or therapeutic effects. All samples will be non-identified.

Official Title
-----------------
Derivation of Induced Pluripotent Stem Cells From an Existing Collection of Human Somatic Cells

Conditions
-----------------
Amyotrophic Lateral Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Volunteers Male and Female Exclusion Criteria: Below the official age of consent

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?
-----------------
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
-----------------
ALS
Development and Validation of a Morbidity Index for Complications in Minor and Major Abdominal Surgery

Study Overview
=================
Brief Summary
-----------------
The aim is to develop and validate a morbidity index for postoperative complications in patients undergoing visceral surgery.

Official Title
-----------------
Development and Validation of a Morbidity Index for Complications in Minor and Major Abdominal Surgery

Conditions
-----------------
Postoperative Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: ≥ 18 years Capacity to act and no legal guardian Patients with any underlying disease admitted to the Department of Visceral and Transplantation Surgery of the University Hospital of Zurich with planned minor or major visceral surgery German language as daily language. Exclusion Criteria: Patients with cognitive difficulties and diseases, which may yield unreliable answers Patients unable to read and write

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 |
| --- | --- |
| 1<br>questionnair for Patients | |
| 2<br>questionnaire for Nurses | |
| 3<br>questionnaire for Physicians | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to develop and validate a morbidity index |  | preoeprativ and one day before discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
A self-administered questionnaire to collect data from patients, physicians and nurses about the severity of postoperative surgical complications., Based on this questionnaire we will develop the morbidity index
Study of the Prognosis of Patients With Heart Failure With Preserved Ejection Fraction

Study Overview
=================
Brief Summary
-----------------
Study of the prognosis of patients with heart failure with preserved ejection fraction

Detailed Description
-----------------
Obesity is an independent risk factor for heart failure with preserved ejection fraction (HFpEF), however, the impact of visceral fat area (VFA) in patients with HFpEF is unclear. According to established process of patients' selection, a total of 172 patients whose mean age was 72 years were included in this study, and the median follow-up duration was 395.5 days(interquartile range: 207.5 to 535.5 days). All patients were divided into two groups based on the best cut-off value of VFA, and the primary outcome of this study was all-cause death in patients with HFpEF. The aim of this study was to clarify whether VFA has prognostic value in patients with HFpEF by Kaplan-Meier analysis and cox analysis.

Official Title
-----------------
Study of the Prognosis of Patients With Heart Failure With Preserved Ejection Fraction

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult aged >=18years old; Diagnosed with HFpEF.Diagnostic criteria including: 1）left ventricular ejection fraction ≥50%； 2）with the symptoms and/or signs of heart failure； 3）BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL； 4）at least one additional criterion: relevant structural heart disease(LVH and/or LAE) or diastolic dysfunction Exclusion Criteria: Age <18 years old； LVEF less than 45% at any time; cancer diagnosis.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| death | all-cause death | The median follow-up time of 395.5 days(interquartile range: 207.5 to 535.5 days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
visceral fat area
Is Prophylactic Antibiotics Necessary In Otherwise Healthy Adult Patients Undergoing Ureteroscopic Procedures for Ureteral Stones?

Study Overview
=================
Brief Summary
-----------------
The present study aims to investigate the relative efficacy, safety and risk of a single-dose prophylaxis in otherwise healthy adult patients undergoing ureteroscopic procedures for ureteral stones.

Conditions
-----------------
Ureteral Stones

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 100 otherwise healthy adult patients. Aged from 20 to 65 years. Undergoing ureteroscopic procedures for ureteral stones. Exclusion Criteria: Have the urine road the infection before the surgical operation, the surgical operation once took antibiotics the first 2 week. Pregnant or the women been breast feeding.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| prophylactic antibiotics<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of clinically definite urinary tract infection confirmed by urinary analysis or urinary culture. |  | within the first 10 days (plus or minus 5 days) after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prophylactic antibiotics, urinary tract infection.
Diet and Muscle Function In Older Adults

Study Overview
=================
Brief Summary
-----------------
This research study was conducted to investigate the effects of a high protein diet on the efficiency of energy use at rest and at low-levels of physical activity. The hypothesis was that a high intake of dietary protein would result in a less efficient use of energy in skeletal muscle in older adults.

Detailed Description
-----------------
This research study was conducted to investigate the effects of a high protein diet on the efficiency of energy use at rest and at low-levels of physical activity. The hypothesis was that a high intake of dietary protein would result in a less efficient use of energy in skeletal muscle in older adult

Official Title
-----------------
Diet and Muscle Function In Older Adults

Conditions
-----------------
Sarcopenia

Intervention / Treatment
-----------------
* Dietary Supplement: Whey protein supplementation
* Dietary Supplement: Carbohydrate (polycose) supplementation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 65 years and older Exclusion Criteria: Diabetic Acute symptoms of cardiovascular disease or congestive heart failure uncontrolled hypertension supplemental oxygen consumption at rest or during exercise lactose intolerance inability to ride a stationary cycle

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whey protein supplementation<br>50 grams of whey blended into frozen drink | Dietary Supplement: Whey protein supplementation<br>* subjects are asked to consume a smoothie with whey protein added<br>|
| Experimental: Carbohydrate supplementation<br>50 grams of polycose blended into frozen drink | Dietary Supplement: Carbohydrate (polycose) supplementation<br>* Subjects are asked to consume a beverage with polycose added<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary protein effects on muscle energy use | gross mechanical efficiency of muscle, consuming high and low protein supplements | participants will be measured over an average of 26 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of protein supplements on food intake | effects of high protein or high carbohydrate supplements on overall energy consumption in older adults. | participants will be measured over an average of 26 days |
Fecal Microbiota Transplantation and Newly Diagnosed Ulcerative Colitis (UC)

Study Overview
=================
Brief Summary
-----------------
In this FinUC study we are trying to find out the efficacy and safety of the Fecal microbiota transplantation (FMT) in newly diagnosed active ulcerative colitis patients. The study group with newly diagnosed active ulcerative colitis receive an FMT via colonoscopy from a tested general donor, frozen and thawed from a fecal bank at week 0 and at week 4 as an enema at the study nurse´s visit. The control group will be given colored water. The main aim of the FinUC study is to determine how the FMT change of the gut microbiota composition in newly diagnosed active ulcerative colitis patients. The other aim is to determine efficacy and mechanisms of fecal microbiota transplantation.

Official Title
-----------------
Fecal Microbiota Transplantation in Newly Diagnosed Ulcerative Colitis Patients

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Other: Fecal microbiota transplantation
* Other: Colored water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years Active newly diagnosed colitis (Mayo score <11) Signed informed consent Exclusion Criteria: Fulminant severe colitis (Mayo score 11-12 or Truelove and Witts criteria) Gastrointestinal infection Pregnancy Antibiotic therapy at the baseline On-going probiotic medication Unable to provide signed informed consent

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
Interventional Model Description: Randomized placebo-controlled pilot study. Accrued participants were randomized 1:1 using a computer generated randomization algorithm (www.random.org).
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: The study group<br>The study group with newly diagnosed active ulcerative colitis receive an FMT via colonoscopy from a tested general donor, frozen and thawed from a fecal bank at week 0 and at week 4 as an enema at the study nurse´s visit | Other: Fecal microbiota transplantation<br>* Fecal microbiota transplantation from a tested general donor, frozen and thawed from a fecal bank<br>|
| Placebo Comparator: The control group<br>The control group will be given colored water at same timepoints | Other: Colored water<br>* Colored water (placebo)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified gut microbiota composition | Increased species richness and alfa-diversity | at week 12 |
RIAT Registry: Reason for Not Intensifying Antihypertensive Treatment

Study Overview
=================
Brief Summary
-----------------
To support physicians in their active management of hypertensive patients. By targeting specific systolic and diastolic blood pressure (BP) figures physicians will closely monitor the BP values and as such will have an individualized control of the treatment in each patient.

Official Title
-----------------
An International Registry in Essential Hypertension

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

Participation Criteria
=================
Eligibility Criteria
-----------------
The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional. Main criteria are listed hereafter: Inclusion Criteria: Adult hypertensive Either newly diagnosed and untreated or previously treated and uncontrolled Patients of both sexes with essential hypertension Exclusion Criteria: Known secondary hypertension Known secondary curable hypertension (i.e. pheochromocytoma, aldosterone producing adenoma, Cushing disease). Patients with renal disease are not excluded.
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 |
| --- | --- | --- |
Managment of Cardiorespiratory Arrest

Study Overview
=================
Brief Summary
-----------------
CPR will be done based on American Heart Association Guidelines for Cardiopulmonary Resuscitation (2015) and Emergency Cardiovascular Care of Pediatric and Neonatal Patients.

Detailed Description
-----------------
the present study is to assess the quality of care and management of children with cardiorespiratory arrest admitted to assuit university children hospital according to the American Heart Association Guidelines for Cardiopulmonary Resuscitation (2015) and Emergency Cardiovascular Care of Pediatric and Neonatal Patients searching for defect,obstacles,or need to improve health service. CPR will be done based on American Heart Association Guidelines for Cardiopulmonary Resuscitation (2015) and Emergency Cardiovascular Care of Pediatric and Neonatal Patients.

Official Title
-----------------
Managment of Cardiorespiratory Arrest

Conditions
-----------------
Assess the Quality Ofmanagement of Children With Cardiorespiratory Arrest in Assuit University Children Hospital According to the( A H A)Guidelines

Intervention / Treatment
-----------------
* Other: clinical audit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Seriously ill Patients who will be admitted with or will be developed cardiorespiratory arrest and undergo CPR. Age2 month to 18 years. Both sex. Exclusion Criteria: Traumatic cause (blunt, penetrating, burn) of arrest

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum 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: clinical audit|is to assess the quality of care and management of children with cardiorespiratory arrest admitted to assuit university children hospital according to the American Heart Association (AHA) Guidelines for Cardiopulmonary Resuscitation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| managment of cardiorespiratory arrest in children | assesment of cardiorespiratory ressucitation | one year |
Somatic Comorbidities in Psychiatric Patients

Study Overview
=================
Brief Summary
-----------------
Prevalence of somatic comorbidities in psychiatric patients hospitalized in Psychiatric hospital or treated ambulatory or in daily hospital. Comparison of prevalence of somatic comorbidities in psychiatric patients population and the general Croatian population.

Official Title
-----------------
Somatic Comorbidities in Psychiatric Patients

Conditions
-----------------
Schizophrenia, Major Depression Disorder, Bipolar Affective Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: treatment in psychiatric hospital Exclusion Criteria: acute suicidality dementia mental retardation acute psychosis intoxication inability to answer the questionnaire by themselves

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Hospitalized<br>Hospitalized psychiatric patients | |
| Daily hospital<br> | |
| Outpatients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of somatic comorbidities |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression- Improvement scale (CGI-I), Change from diagnosis |  | from baseline to 12 months |