linjc16/ctgov huggingface dataset:
Mild Valvar Pulmonary Stenosis

Study Overview
=================
Brief Summary
-----------------
Mild valvar pulmonary stenosis can be detected in 1/10,000 live births. Historical data suggested that most of these patients do well. Nonetheless, the majority of these patients is followed periodically by a pediatric cardiologist and may undergo repeated echocardiographic studies to follow the gradient. Such follow-up can be costly and it is not know if there is any benefit to periodic evaluation.

Detailed Description
-----------------
Young children (less than or equal to 2 years of age) with mild valvar pulmonary stenosis are unlikely to develop worsening stenosis with age and periodic cardiac evaluation is not warranted. To describe the clinical course of children with mild valvar pulmonary stenosis diagnosed in early childhood. To examine the clinical practice patterns of cardiologists caring for these patients. Retrospective chart review of all children diagnosed with mild valvar pulmonary stenosis born between 1984 and 2003 and followed by Sibley Heart Center Cardiology. Patient variables will include: pulmonary valve gradient, need for catheterization, exercise intolerance and endocarditis. Practice variables will include: frequency of follow-up, number of echocardiographic studies, exercise limitations.

Official Title
-----------------
Clinical Management of Children With Mild Valvar Pulmonary Stenosis

Conditions
-----------------
Congenital Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children's Healthcare of Atlanta medical charts 1984 to 2003 diagnosed with mild valvar pulmonary stenosis Patients less than or equal to two years of age Exclusion Criteria: Those who do no meet inclusion criteria

Ages Eligible for Study
-----------------
Maximum Age: 2 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatric, Cardiac, Valvar Pulmonary Stenosis
NeuroStar TMS Therapy System: Utilization and Outcomes

Study Overview
=================
Brief Summary
-----------------
The major objective of this observational study is to describe clinical outcomes of patients receiving treatment with the NeuroStar TMS Therapy system in routine clinical practice.

Official Title
-----------------
NeuroStar TMS Therapy System: Data Management, Analysis and Reporting Format for Clinical Treatment Utilization and Outcomes (Protocol no. 19-50001-000,Rev D

Conditions
-----------------
Major Depressive Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major Depressive Disorder Exclusion Criteria: Contraindications to treatment with TMS
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 |
| --- | --- | --- |
| Total Score on the Patient Health Questionnaire 9-Item (PHQ-9) | The primary outcome measure will reported as the change from baseline through 6 weeks for the total score on the PHQ-9. | Baseline and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total score for the Clinical Global Impressions-Severity (CGI-S) | The change from baseline to endpoint on the total score for the CGI-S will be reported for the 6 week and 12 month time points. | Baseline, 6 weeks and 12 Months | 
| Total score for the Inventory of Depressive Symptoms-Self Report (IDS-SR) | The change from baseline to endpoint on the total score for the IDS-SR will be reported for the 6 week and 12 month time points. | Baseline, 6 weeks and 12 Months | 
| Total Score for the EuroQol Questionnaire (EQ-5D) | The change from baseline to endpoint on the total score for the EQ-5D will be reported for the 6 week and 12 month time points. | Baseline, 6 weeks, and 12 Months. | 
| Health Resource Utilization Questionnaire (HRU) | The change from baseline in health care service utilization reported on the individual questions contained in the HRU will be reported for the 6 week and 12 month time points. | Baseline, 6 weeks, and 12 Months | 
| Short Form 36-Item Questionnaire(SF-36) Individual Factor Scores and General Medical and Mental Health Composite Scores | The change from baseline to endpoint on the Individual Factor Scores and General Medical and Mental Health Composite Scores for the SF-36 will be reported for the 6 week and 12 month time points. | Baseline, 6 weeks, and 12 Months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transcranial magnetic stimulation, TMS, Observational study, Major Depression
The Effect of Obturator Thickness on the Function

Study Overview
=================
Brief Summary
-----------------
the effect of obturator bulb thickness on masticatory function has been verified.

Official Title
-----------------
The Effect of the Wall Thickness of Obturator Bulbs on Masticatory Function in Patients With Maxillectomy

Conditions
-----------------
Maxilla--Cancer

Intervention / Treatment
-----------------
* Device: obturator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: having maxillectomy operation Exclusion Criteria: having radiation therapy before the study

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 71 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low group<br>low thickness group | Device: obturator<br>* variable bulbs<br>* Other names: bulb;|
| Experimental: moderate group<br>moderate thickness group | Device: obturator<br>* variable bulbs<br>* Other names: bulb;|
| Experimental: high group<br>high thickness group | Device: obturator<br>* variable bulbs<br>* Other names: bulb;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the effect of bulb thickness | measuring the efficacy of masticatory function with chewing test | 3 weeks | 
| the effect of weight reduction | measuring the weight differences of prostheses | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obturator, bulb
Intraoperative Air-Test

Study Overview
=================
Brief Summary
-----------------
Although imaging techniques are the reference standard to diagnose alveolar collapse, in the postoperative period and using the peripheral hemoglobin oxygen saturation (SpO2), a non-invasive simple and accurate test (Air-Test) was recently validated to diagnose alveolar collapse. The aim of this study is to non-invasively describe the incidence of intraoperative atelectasis with the Air-Test in an unselected surgical population. In addition, we attempt to describe the association between positive Air-Test and the patient´s preoperative or intraoperative variables.

Official Title
-----------------
Incidence of Intraoperative Positive Air-Test

Conditions
-----------------
Patients With ASA Status I-III Scheduled for Surgery

Intervention / Treatment
-----------------
* Procedure: Air-Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologist (ASA) I-IV General Anesthesia Mechanical ventilation Exclusion Criteria: age < 18 years old pregnancy patients undergoing cardiothoracic surgery ASA physical status V

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 |
| --- |
|Procedure: Air-Test|The Air Test simply consisted in breathing room air for 5 min during anesthesia while measuring peripheral oxygen saturation by Pulse oximetry|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients with positive Air-Test | Positive Air-Test defined as SpO2 < 97% while breathing room air | During surgery |
A Phase IV, Multi-Center, Open-Label Trial of Sibutramine in Combination With a Hypocaloric Diet in Obese and Overweight Thai Subjects.

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the safety and weight loss when sibutramine is used in overweight and obese subjects.

Official Title
-----------------
Safety and Weight Reduction of Sibutramine in the Treatment of Thai Obese and Overweight Subjects

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: sibutramine hydochloride monohydrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has nutritional obesity and BMI >30 kg/m Exclusion Criteria: Type 1 or type 2 diabetes mellitus Inadequately controlled hypertension History of Gilles de la Tourette's Syndrome. Use of any MAOIs, SSRIs, amino acids, antimigraine drugs, opioids Hypothyroidism or hyperthyroidism. History of: benign prostatic hyperplasia neurological disorders psychiatric illness severe renal or hepatic impairments narrow-angle glaucoma History of cardiovascular disease or cerebrovascular disease Persistent tachycardia at rest Pulmonary hypertension Phaeochromocytoma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: sibutramine hydochloride monohydrate<br>* 10 mg QD with the option to increase dose to 15 mg QD up until Week 4<br>* Other names: Meridia;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss |  | 48 weeks | 
| Safety parameters |  | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist and hip circumference |  | 48 weeks | 
| Fasting glucose |  | 48 weeks | 
| Fasting lipids |  | 48 weeks | 
| Uric acid |  | 48 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sibutramine, Obesity
SMS - Heals My Health

Study Overview
=================
Brief Summary
-----------------
Therapeutic patient education is an approach that has shown its usefulness in rheumatology, but the duration of its impact is limited, and therapeutic revisions are regularly necessary. The practice of physical activity is one of the goals of TPE in rheumatology and new technologies, such as SMS messages represent a possible complementary tool to amplify behavioral changes The study primary objective is to evaluate the impact of individualized SMS compared to standard SMS messages on the physical activity of patients with chronic inflammatory rheumatism or osteoporosis, included in a therapeutic education program. Our hypothesis is that individualized SMS has a higher efficiency compared to standard SMS messages to increase the practice of physical activity in these patients.

Official Title
-----------------
Impact of Personalized SMS in Relay of Therapeutic Education Programs to Improve the Physical Activity of Patients in Rheumatology

Conditions
-----------------
to Help Improve the Quality of Life of Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient age from 18 to 75 years Participated in therapeutic patient education program osteoporosis disease and inflammatory rheumatism disease Having given their written consent French speaking Possessing a telephone tool that accepts SMS Exclusion Criteria: Patients unable to read SMS for practical, linguistic or cognitive reasons Patients who can not, for medical reasons or disability, set up 30 minutes of moderate physical activity (walking or other moderate activity) per day Having already participated in a similar study in inflammatory rheumatism or osteoporosis Already having the required level of physical activity: performing more than 30 minutes of moderate physical activity (walking or other moderate activity)

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients receiving an individualized SMS<br> | |
| patients receiving a standard SMS<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical activity | evaluate the percentage of patients reaching 30 minutes of moderate physical activity | 1 YEAR |
A Randomized Control Trial to Assess Early Clinical and Functional Outcome of the ROCC and LCS Total Knee Implant Designs

Study Overview
=================
Brief Summary
-----------------
This is a prospective Randomised Control Trial to compare the Early Clinical and Functional Outcome of the ROCC and LCS total knee arthroplasty implant designs.

Detailed Description
-----------------
This study compares two similar designs of cementless rotating bearing total condylar knee replacements. The study will be conducted at a single clinical unit with a senior orthopaedic surgeon implanting all devices.Their performances will be assessed by clinical scores and comprehensive function outcome documentation undertaken by qualified physiotherapists. The persons undertaking the assessments will be blinded to which implants the patients have.

Official Title
-----------------
A Prospective Randomized Study on Early Clinical and Functional Outcome of the ROCC and LCS Total Knee Arthroplasty Implant Designs

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Device: LCS Knee
* Device: ROCC Knee


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suitable for cementless knee replacement Patients skeletally mature and under 80 years of age at pre-operative clinic Patients presenting with osteoarthritis of the knee Patients must be ambulatory at time of pre-operative clinic Patients must be able to understand instructions and be will to return for follow-up Exclusion Criteria: Previous knee surgery (except arthroscopic/open menisectomy) Patients with inflammatory arthritis Patients with significant medical co-morbidity - ASA IV Disorders causing abnormal gait or significant pain Patients unable to consent Severe visual impairment

Ages Eligible for Study
-----------------
Maximum Age: 80 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: 1<br>ROCC | Device: ROCC Knee<br>* Cementless total knee arthroplasty with ROCC Knee<br>|
| Active Comparator: 2<br>LCS | Device: LCS Knee<br>* Cementless total knee arthroplasty with LCS Knee<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Knee Society Score |  | Preoperative, 8weeks, 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC |  | preoperative, 8 weeks, 1 year | 
| VAS Pain |  | Preoperative, 4weeks, 8weeks, 3months, 1 year |
Impact of OAB Symptoms on Quality of Life in Croatia

Study Overview
=================
Brief Summary
-----------------
Overactive bladder (OAB) has a negative impact on the daily activities of affected individuals. OAB affects an estimated 12-17% of adults and has a similar reported prevalence in men and women. It has the potential to impair multiple domains of quality of life, including restriction of social and work life, while also resulting in higher healthcare resource use and costs. The primary objective of the present study was to evaluate, in a Croatian population reporting symptoms of OAB, the effect on work productivity and treatment behaviors (treatment seeking, receiving treatment, treatment dissatisfaction and treatment discontinuation).

Official Title
-----------------
Impact of OAB Symptoms on Work, Quality of Life and Treatment-seeking Behavior in Croatia

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

Intervention / Treatment
-----------------
* Other: Overactive Bladder-Validated 8-question Screener (OAB-V8)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: consenting adult patients who had an OAB diagnosis by their healthcare practitioner and were about to start mirabegron treatment as part of routine clinical practice were eligible for enrollment. Exclusion Criteria: mixed incontinence where stress incontinence was the predominant symptom (as determined by the investigator) severe uncontrolled hypertension (i.e. systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg) anxiety and/or depression pregnancy women who reported having either a current or previous (within one month) urinary tract infection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| OAB group<br>Group with diagnosed overactive bladder. | Other: Overactive Bladder-Validated 8-question Screener (OAB-V8)<br>* OAB-V8 is an eight-item, self-reported questionnaire that assesses the burden of OAB and the degree of bother caused by the symptoms. Since its development as a subscale of the overactive bladder questionnaire (OAB-q), the OAB-V8 questionnaire has been used to screen for OAB and to assess OAB symptom burden and severity.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OAB-V8 score > 8 | The primary study objective is to investigate the impact of individual LUTS on specific outcomes in the population reporting OAB symptoms. OAB-V8 score. | At the point of recruitment |
Tetracycline to Limit the Innate Immune Response in Acute Respiratory Distress Syndrome

Study Overview
=================
Brief Summary
-----------------
The acute respiratory distress syndrome (ARDS) is a severe form of respiratory failure with a mortality rate of approximately 40%. Despite advances in its supportive treatment such as lung protective ventilation or restrictive fluid management, no effective pharmacotherapy exists to treat ARDS. Emerging preclinical data indicates that excessive activation of the inflammasome-Caspase 1 pathway plays a key role in the development of ARDS. Tetracycline has anti-inflammatory properties via inhibiting inflammasome-caspase-1 activation. Since not much is known about the activation of the inflammasome in clinical ARDS, the purpose of this study is i) to investigate the the inflammasome-caspase-1 activation in clinical ARDS and ii) inhibit the innate immune response of alveolar leucocytes obtained by tetracycline from patients with ARDS

Official Title
-----------------
Innate Immunity in Acute Respiratory Distress Syndrome: A Translational Approach to Limit Inflammasome-dependent Lung Inflammation by Tetracycline

Conditions
-----------------
Adult Respiratory Distress Syndrome, Pneumonia, Sepsis

Intervention / Treatment
-----------------
* Other: Sampling of Blood and bronchoalveolar lavage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Informed consent of the patient Diagnosis of ARDS for < 48 h Exclusion Criteria: Age < 18 years Missing informed consent Immune therapy Autoimmune 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

| Intervention/Treatment |
| --- |
|Other: Sampling of Blood and bronchoalveolar lavage|Multiplex assays for pro- and anti-inflammatory markers and incubation of immune cells isolated from serum and bronchoalveolar lavage fluid of patients with ARDS.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokine Levels in Serum and bronchoalveolar fluid | determined by multiplex Assay [pg/ml] | 1 week | 
| Activation Status of immune cells from blood and bronchoalveolar fluid | incubation of immune cells with tetracycline and Determination of cytokines by multiplex assay [pg/ml] | 1 week | 
| Alarmins in Serum and bronchoalveolar fluid | Determination by western blot, qPCR or flow cytometry | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inflammasome, Caspase, NLRP3, Antibiotics, Tetracycline