linjc16/ctgov huggingface dataset:
A Study to Evaluate Breathing Muscle Training in Cardiac Rehab

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand if breathing muscle training combined with cardiac rehabilitation influences the blood flow and blood pressure response during exercise.

Official Title
-----------------
Combined Cardiac Rehabilitation and Inspiratory Muscle Training in Heart Failure

Conditions
-----------------
Healthy, Heart Failure

Intervention / Treatment
-----------------
* Device: Inspiratory muscle training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria - Heart Failure Group: Adult 18 years and older. English speaking. Has a qualifying heart failure indication for center-based cardiac rehabilitation. Inclusion Criteria - Healthy Control Group: Adult 18 years and older. English speaking. Absence of pulmonary, cardiovascular, musculoskeletal, neurologic, or orthopedic diseases. Controls will be matched for age and sex. Exclusion Criteria: HF patients who are unable to engage in a regularly structured exercise training program as part of a clinically indicated center-based outpatient cardiac rehabilitation program. Participants unable/unwilling to provide informed consent. Uremia, history of allergy to iodides. Impaired renal function. Creatinine value greater than 1.3 mg/dL (via clinical record within the past 6 months). Diagnosis of liver disease.

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham arm<br>Perform inspiratory muscle training at 2% maximal inspiratory pressure for 12 weeks. | Device: Inspiratory muscle training<br>* Inspiratory muscle training for 12 weeks at 40% maximal inspiratory pressure<br>|
| Active Comparator: Non-sham arm<br>Perform inspiratory muscle training at 40% maximal inspiratory pressure for 12 weeks. | Device: Inspiratory muscle training<br>* Inspiratory muscle training for 12 weeks at 40% maximal inspiratory pressure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure response | Mean arterial pressure | baseline and 12 week follow up | 
| Change in blood flow response | respiratory muscle blood flow | baseline and 12 week follow up | 
| Change in limb vascular resistance response | Limb vascular resistance | baseline and 12 week follow up |
Comparative Study Between Safety and Effectiveness of High Versus Low Power HOLEP

Study Overview
=================
Brief Summary
-----------------
Holmium laser enucleation (HOLEP) has became a standard of treatment of large prostates that indicates surgery. HOLEP is widely used nowadays. Many settings are used but no optimal setting was world wide adopted. The aim of this trial is to assess the Low-power Holmium laser enucleation of the prostate (LP-HoLEP)and compare to high-power (HP-HoLEP) for enucleation efficiency pertaining to the advantages of lower cost and minimal postoperative dysuria, storage symptoms, and negative sexual impact.

Official Title
-----------------
Comparative Study Between Safety and Efficacy of High Versus Low Power HOLEP in Enucleation of the Prostate; Prospective Randomized Double Blind Trial

Conditions
-----------------
Benign Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Procedure: HOLEP for treating BPH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: large prostate indicated for surgical intervention. Exclusion Criteria: prostate cancer recurrent adenomas associated neurologic factors that may affect outcomes (e.g., neurogenic bladder)

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

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

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: HoLEP will be performed using 100W Versapulse, Luminis Inc., with 2J/25Hz for LP-HoLEP and 2J/50Hz for HP-HoLEP.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LP-HoLEP<br>2J/25Hz setting | Procedure: HOLEP for treating BPH<br>* HoLEP will be performed using 100W Versapulse, Luminis Inc., with 2J/25Hz for LP-HoLEP and 2J/50Hz for HP-HoLEP.<br>|
| Active Comparator: HP-HoLEP.<br>2J/50Hz setting | Procedure: HOLEP for treating BPH<br>* HoLEP will be performed using 100W Versapulse, Luminis Inc., with 2J/25Hz for LP-HoLEP and 2J/50Hz for HP-HoLEP.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enucleation Efficiency | Enucleated weight/min will be evaluated. | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dysuria will be assessed by dysuria visual analog scale | burning micturation after the procedure. Dysuria will be assessed by dysuria visual analog scale | 2 weeks | 
| The complications of both techniques | The complications will be classified according to the modified Clavien classification system. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HOLEP, Enucleation, Prostate
Risk Factors of Neonatal Thrombosis

Study Overview
=================
Brief Summary
-----------------
The incidence of symptomatic thrombosis is between 2.4 and 6.8 per 1000 neonatal intensive care unit admission while it is 5.1 per 100 000 live births. Compared to adults, the anticoagulant and fibrinolytic system of newborns is significantly different. In this study, the aim is to evaluate infants with neonatal thrombosis in our unit to characterize acquired and genetic risk factors, the laboratory work-up parameters and the diagnosis approach.

Detailed Description
-----------------
All newborn patients diagnosed with neonatal thrombosis in our NICU between 2014 and 2019; were included in the study. Patients' data: maternal and neonatal characteristics, consanguinity, need for resuscitation, Apgar scores, diagnoses, need for mechanical ventilation, sepsis, catheter placement, treatment regimens and hospital outcomes; Laboratory findings: CBC; D-dimer levels and the performed genetic test Thrombosis diagnosis was confirmed by imaging techniques such as ultrasonography (USG), echocardiography, and magnetic resonance imaging (MRI). The genotypes: Factor V (Leiden) G1691A, prothrombin G20210A, MTHFRC677T, MTHFRA1298C, PAI-SERPINE1, Factor XIII V34L mutations

Official Title
-----------------
Evaluation of Acquired and Hereditary Risk Factors of Neonatal Thrombosis: Single-centre Experience

Conditions
-----------------
Thrombosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All newborn accepted at NICU Exclusion Criteria: No

Ages Eligible for Study
-----------------
Minimum Age: 1 Day

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Newborn with thrombossis<br>All admitted newborns in NICU during the study period | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thrombosis in the neonatal period is multifactorial |  | January 2022 | 
| Hereditary thrombophilia factors also should be thought |  | January 2022 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
newborn, hereditary risk factors
Clinical Study of Ultrasonic Artificial Intelligence and Fine Needle Aspiration in Qualitative Diagnosis of Thyroid Nodules

Study Overview
=================
Brief Summary
-----------------
To study the value of thyroid artificial intelligence diagnosis system and fine needle puncture in the diagnosis of benign and malignant thyroid nodules, so as to provide evidence-based medical evidence for the diagnosis of benign and malignant thyroid nodules by artificial intelligence.

Official Title
-----------------
Clinical Study of Ultrasonic Artificial Intelligence and Fine Needle Aspiration in Qualitative Diagnosis of Thyroid Nodules

Conditions
-----------------
Thyroid Nodule

Intervention / Treatment
-----------------
* Diagnostic Test: THYROID AI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) Age 18-75 years old, regardless of gender; (2) The nodules were observed with complete transverse and longitudinal standard sections; (3) The nodules were observed and underwent thyroid fine needle aspiration, including cytology and BRAF gene mutation detection; (4) Patients voluntarily entered the study after informed consent. Exclusion Criteria: (1) If the observed nodule is less than 2mm or more than 50mm, the artificial intelligence system cannot recognize it; (2) Uncontrolled subacute thyroiditis and hyperthyroidism; (3) Previous thyroid surgery or radiofrequency ablation of thyroid nodules; (4) History of neck trauma.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Experimental: THYROID AI<br> | Diagnostic Test: THYROID AI<br>* thyroid artificial intelligence diagnosis system and fine needle puncture in the diagnosis of benign and malignant thyroid nodules<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| THYROID AI | classify thyroid nodules as Benign or Malignant | immediately after the procedure |
Hyponatremia and Hypoalbuminemia is Morbimortality Predictors in Coronary Artery Bypass Graft Surgery

Study Overview
=================
Brief Summary
-----------------
Coronary artery disease is a common medical disease in many populations. The pathogenesis of this disease is very complex. Surgery is one of the treatment choices. Assessing the risk factors will improve the surgical outcome. In this study some biochemical parameters were evaluated to find out the relationship between these parameters (electrolytes and albumin vs)

Official Title
-----------------
Hyponatremia and Hypoalbuminemia is Morbimortality Predictors in Coronary Artery Bypass

Conditions
-----------------
Coronary Artery Disease, Hyponatremia, Hypoalbuminemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent coronary artery bypass graft surgery Elective surgery Exclusion Criteria: Pediatric patients Off-pump surgery Emergent surgery

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| myocardial infarction | Increase in cardiac enzymes( >0,1 µg/L ) | One month |
Substantial Equivalence Study for Kai Medical Non-Contact Respiratory Rate Monitor

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the respiratory rate provided by Kai Medical Non-Contact Respiratory Rate Monitors are as accurate as that provided by the currently used methods, including respiratory chest bands.

Official Title
-----------------
How Does the New Kai R Spot 100 Respiratory Monitor Compare to the Currently Used Respiratory Monitor for Measuring Respiratory Rate During Overnight Sleep Studies?

Conditions
-----------------
Respiration

Intervention / Treatment
-----------------
* Device: Non-Contact Respiratory Rate Monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Every patient undergoing an overnight polysomnography study can be included. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 29 Days

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 |
| --- | --- |
| Sleep Clinic<br> | Device: Non-Contact Respiratory Rate Monitor<br>* The Non-Contact Respiratory Rate Monitor provides a measurement of respiratory rate at a single point in time for neonates, pediatrics and adults. The Non-Contact Respiratory Rate Monitor provides a continuous monitor, measurement, and display of the respiratory rate, respiratory patterns, depth of breath, history/events and respiratory activity of a subject for neonates, pediatrics, and adults.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
RCT Iron Supplementation and Malaria Chemoprophylaxis for Prevention of Severe Anemia and Malaria in Tanzanian Infants

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to evaluate the efficacy of weekly iron supplementation and the efficacy of malaria chemoprophylaxis from 2 to 12 months of age in infants living in an area of intense and perennial malaria transmission

Detailed Description
-----------------
411 Tanzanian infants were randomly assigned to receive weekly malaria prophylaxis with Deltaprim™ (3.125 mg pyrimethamine plus 25 mg dapsone) or placebo from ages 2-12 months. Children were followed-up until age 4 years. Uncomplicated febrile malaria, severe malaria and anaemia morbidity were assessed through hospital-based passive surveillance.

Official Title
-----------------
The Prevention of Anaemia and Malaria in Infants in an Area of Intense and Perennial Malaria Transmission

Conditions
-----------------
Malaria, Anemia

Intervention / Treatment
-----------------
* Drug: Deltaprim (3.125 mg pyrimethamine plus 25 mg dapsone)
* Drug: iron (2 mg/kg/daily)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Born in San Francis Designated District Hospital of Ifakara Exclusion Criteria: Obvious severe congenital malformation such as: spina bifida, hydrocephalus or anencepahlus Twins Birth weight < 1,5 kg Clinical signs of cerebral asphyxia Clinical signs of neonatal or congenital infection Mother unreliable (deaf, mentally handicapped)

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 1 Day

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Deltaprim (3.125 mg pyrimethamine plus 25 mg dapsone)|nan|
|Drug: iron (2 mg/kg/daily)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Malaria |  | During first year of life | 
| Severe Anemia (PCV < 25%) |  | During first year of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Malaria |  | After first year of life | 
| Severe Anemia (PCV < 25%) |  | After first year of life | 
| Outpatient visits |  |  | 
| Hospital Admissions |  |  | 
| Severe malaria |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Plasmodium Falciparum, Antimlarial chemoprophylaxis, Iron supplementation, Tanzania
Dose-Ranging Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
The trial is designed to identify an appropriate dose of QAB149 for delivery via a multiple dose inhaler for use in the COPD Phase III program.

Official Title
-----------------
Dose-Ranging Study in Patients With COPD

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Drug: QAB149


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of COPD Age 40-75 years Smoking history Exclusion Criteria: Other serious disease Allergy to QAB149 Respiratory tract infection

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: QAB149|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function measured between 22 and 24 hours after dosing on Day 1 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function measured on days 1 and 7 at various intervals after dosing |  |  | 
| Safety measurements |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, adults, QAB149
An Observational Study of Avastin (Bevacizumab) in Patients With Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
This observational study will collect data about safety in female patients with advanced ovarian epithelial cancer with measurable residual disease after surger y. The treating physician has decided to treat the patients with Avastin (bevaci zumab) in combination with chemotherapy followed by Avastin monotherapy accordin g to the local label. Data will be collected for 72 weeks.

Official Title
-----------------
Ascites Control Treating Ovarian Cancer With Bevacizumab: ACT-OB

Conditions
-----------------
Ovarian Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients over 18 years of age Histologically confirmed Advanced Epithelial Ovarian Cancer Confirmed ascites prior to surgery Residual disease after surgery Patients are chemotherapy naïve or have received only one prior line of treatment for their disease International Federation of Gynecology and Obstetrics (FIGO) stage IIIb or IV disease Eastern Cooperative Oncology Group (ECOG) performance status <=2 Patients must meet treatment eligibility requirements according to treating physician and Summary of Product Characteristics (SmPC) criteria for Avastin plus chemotherapy. Exclusion Criteria: Pregnancy or lactation Low grade tumors, since this does not necessarily requires systemic treatment. Complete surgical resection Uncontrollable hypertension Unexplained bleeding Known hypersensitivity to any components of bevacizumab All contraindications specified in the respective Summary of Product Characteristics (SmPC) and/or local labelling of Avastin and the corresponding chemotherapy must be adhered to by the physician.

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

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

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

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

Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients who require paracenthesis during treatment with Avastin |  | 72 weeks | 
| The amount of ascitic fluid extracted during treatment with Avastin |  | 72 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | 72 weeks | 
| To evaluate Eastern Cooperative Oncology Group (ECOG) performance status before and after start of therapy |  | 72 weeks | 
| To determine regional epidemiologic data for the studied population |  | 72 weeks |