linjc16/ctgov huggingface dataset:
Giessen Pulmonary Hypertension Registry and Biobank

Study Overview
=================
Brief Summary
-----------------
Giessen Pulmonary Hypertension Registry and Biobank

Detailed Description
-----------------
Long-term transplant-free survival and its determinants will be investigated in patients with Pulmonary Hypertension (diagnosed by right heart catheterization) within a prospective registry at a single referral center in Giessen, Germany.

Official Title
-----------------
Giessen Pulmonary Hypertension Registry and Biobank

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Right heart catheterization for PH diagnosis in Giessen Exclusion Criteria: informed consent missing
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pulmonary arterial hypertension<br>Group 1 PH | |
| Pulmonary hypertension due to left heart disease<br>Group 2 PH | |
| Pulmonary hypertension due to lung disease<br>Group 3 PH | |
| Chronic thromboembolic pulmonary hypertension<br>Group 4 PH | |
| Miscellaneous<br>Group 5 PH | |
| Exclusion PH<br>Patient with invasively excluded PH | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Transplant-free survival of PH patients | Up to 20 years after enrollment |
Bariatric Surgery and Pharmacokinetics of Hydrochlorothiazide

Study Overview
=================
Brief Summary
-----------------
Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on hydrochlorothiazide are investigated.

Official Title
-----------------
Bariatric Surgery and Pharmacokinetics Hydrochlorothiazide: BAR-MEDS Hydrochlorothiazide

Conditions
-----------------
Obesity, Morbid

Intervention / Treatment
-----------------
* Drug: Hydrochlorothiazide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway Being a Norwegian citizen Exclusion Criteria: Having previously undergone resections in the GI-tract

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Hydrochlorothiazide|Patients are tested for their normal prescription hydrochlorothiazide medication|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hydrochlorothiazide concentration in blood serum (area under curve (AUC)) |  | From baseline to 1 year postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bariatric surgery, Gastrointestinal tract, Biological availability, Pharmacokinetics, Hydrochlorothiazide
DMSO Efficacy in IC/PBS Patients During and After Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the efficacy of dimethylsulphoxide (DMSO) cocktail in patients with interstitial cystitis during the treatment period (12 weeks) and after it (at 6 weeks, 3, 6 and 12 month).

Detailed Description
-----------------
The modern treatment of IC is a multi-modal treatment which includes behavioural treatment, physiotherapy of the pelvic floor musculature, oral medication (e.g. Amitryptiline) and intra-vesical instillation (e.g. DMSO, steroids, heparin). These treatments were found to be effective in a number of studies and are approved by the FDA. However, the optimal duration of intra-vesical instilation is not known. All patients with IC (according to the international continence society criteria) will receive 12 weekly intra-vesical instillation of DMSO. All patients will fill an O'leary-Sant questionaire and a urination diary before treatment, after 3, 6, 9 and 12 treatments and at 6 weeks, 3, 6 and 12 month after the end to the treatment.

Official Title
-----------------
Efficacy of DMSO Cocktail Treatment in Interstitial Cystitis Patients During and After Treatment

Conditions
-----------------
Cystitis, Interstitial

Intervention / Treatment
-----------------
* Drug: DMSO cocktail


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with IC according to International Continence Society: more than 6 month of pelvic pain urinary frequency, urgency, dyspareunia Exclusion Criteria: genitourinary tract infection known genitourinary malformation

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DMSO cocktail<br>intra-vesical: DMSO 50% in 50 cc water for injection 10 cc heparin 5000 IU hydrocortisone 100 mg bupivacaine 0.125% | Drug: DMSO cocktail<br>* intra-vesical: DMSO 50% in 50 cc water for injection 10 cc heparin 5000 IU hydrocortisone 100 mg bupivacaine 0.125%<br>* Other names: Dimethyl sulfoxide;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| O'leary-Sant interstitial cystitis symptom and problem questionaire |  | before treatment, at 3, 6, 9 and 12 treatments, 6 weeks, 3, 6, 12 month after last treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urination diary |  | before treatment, at 3, 6, 9 and 12 treatments, 6 weeks, 3, 6, 12 month after last treatment |
The Association of Neurotoxin Exposure With Parkinson's Disease and Parkinsonism in World War II Veterans and Other Men

Study Overview
=================
Brief Summary
-----------------
This program aims to investigate factors associated with development of parkinsonism or idiopathic Parkinson's Disease in an ongoing cohort of patients established in 1965 who are currently undergoing their sixth examination.

Official Title
-----------------
The Association of Neurotoxin Exposure With Parkinson's Disease and Parkinsonism in World War II Veterans and Other Men

Conditions
-----------------
Parkinson's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
This is a cohort study. Population consist of 8,006 Japanese-American men.

Ages Eligible for Study
-----------------
Minimum Age: 81 Years

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

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 |
| --- | --- | --- |
Smartphone Message to Improve the Drug Compliance in Pregnant Women.

Study Overview
=================
Brief Summary
-----------------
As technology advances, smartphones are now widely available and can provide a convenient and effective means to improve drug compliance by sending an electronic reminder on a regular basis. In a meta-analysis of 16 RCTs in assessing of drug compliance in chronic diseases, text message significantly improves medication compliance (OR, 2.11; 95% CI, 1.52-2.93; P < 0.001). The drug compliance improves from 50% to 67.8%, or an absolute increase of 17.8%. Further evaluation is required as most of these RCTs relies on self-reported compliance. This data may be not applicable to pregnant women and trial of using this approach to improve drug compliance during pregnancy is lacking. The investigators hypothesize that the use of smartphone message will improve the drug compliance in pregnant women requiring long term medications. The investigators propose a randomized controlled trial to evaluate the effect of smartphone message.

Official Title
-----------------
A Randomized Controlled Trial on the Use of Smartphone Message to Improve the Drug Compliance in Pregnant Women.

Conditions
-----------------
Pregnancy Related

Intervention / Treatment
-----------------
* Device: smartphone message


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All women age ≥ 18 years old Able to receive electronic reminder through smartphohne Gestational age less than 16 completed weeks as defined by pelvic ultrasound Part 1: Need to take aspirin or progesterone for prevention of pre-eclampsia or preterm birth respectively Part 2: Given multivitamin as health supplementation Exclusion Criteria: For Part 1: History of adverse reaction to aspirin History of adverse reaction to progesterone History of breast or genital tract malignancy History of suspected thromboembolic disease Congenital uterine anomaly Unwillingness or inability to comply with study procedures Known paternal or maternal abnormal karyotype

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smartphone<br>Receive daily whatsapp/ SMS message remind the drug intake. | Device: smartphone message<br>* Receive daily whatsapp/ SMS message to remind the drug intake<br>|
| No Intervention: Control<br>receive instruction to take the medication at recruitment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance | number of tablet taken/ total number of tablets expected to take | through study completion, an average of 9months |
Evaluation of the Cardioblate Closure Device in Facilitating Occlusion of the Left Atrial Appendage

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the performance of the Cardioblate Closure Device to occlude the LAA

Official Title
-----------------
Evaluation of the Cardioblate Closure Device in Facilitating Occlusion of the Left Atrial Appendage

Conditions
-----------------
Left Atrial Appendage Occlusion

Intervention / Treatment
-----------------
* Device: Medtronic LAA Occlusion Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is greater than or equal to 18 years of age and less than or equal to 80 years of age Concomitant indication for cardiac surgery for one or more of the following:mitral valve repair or replacement, aortic valve repair or replacement, tricuspid valve repair or replacement, CABG (>=60 years of age), CABG (< 60 years of age with a history of atrial fibrillation), surgical ablation or Maze procedure The subject is willing and able to provide written informed consent and comply with study requirements The subject is not contra-indicated for intra-operative transesophageal echocardiogram (TEE) Exclusion Criteria: Thrombus in the LAA and/or left atrium Prior LAA isolation attempts Subject is unable to take an anticoagulant during the study follow-up period Subject is undergoing an emergency cardiac procedure Life expectancy of less than 12 months Pregnancy or desire to be pregnant within the 12 months of the study procedure

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Medtronic LAA Occlusion Device|Placement of the occlusion band on the LAA|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete occlusion of the left atrial appendage |  | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the composite incidence rate of device-related adverse events |  | Discharge/30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
left atrial appendage, LAA, atrial fibrillation, AF
Sildenafil in Acute Pulmonary Embolism

Study Overview
=================
Brief Summary
-----------------
To investigate if acute pulmonary vasodilation by sildenafil improves right ventricular function in patients with acute intermediate-high risk pulmonary embolism (PE).

Detailed Description
-----------------
Patients with PE randomized to a single oral dose of sildenafil 50mg (n=10) or placebo (n=10) as add-on to conventional therapy. Right ventricular function evaluated immediately before and shortly after (0.5-1.5h) randomization by right heart catheterization (RHC), trans-thoracic echocardiography (TTE), and cardiac magnetic resonance (CMR). The primary efficacy endpoint was cardiac index measured by CMR.

Official Title
-----------------
Pulmonary Vasodilation by Sildenafil in Acute Pulmonary Embolism

Conditions
-----------------
Pulmonary Embolism

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with acute pulmonary embolism confirmed by contrast enhanced computed tomography (CT) symptom duration of less than 14 days older than 18-80 years right ventricular/left ventricular ratio (RV/LV) >1 measured by trans-thoracic echocardiography (TTE, 1 cm above the atrio-ventricular valves in the four-chamber view at end-diastole). Exclusion Criteria: pregnant cardiac arrest that required cardiopulmonary resuscitation a life expectancy <120 days systolic blood pressure <90 mmHg metal implants, obesity or claustrophobia that excluded the patient from cardiac magnetic resonance (CMR) altered mental status making the patient unable to provide informed consent recent use of drugs with influence on the Nitric oxide-cyclic guanosine monophosphate pathway known or suspected chronic thromboembolic pulmonary hypertension inability to perform study protocol < 72 hours after conventional PE treatment was instituted active bleeding after thrombolysis.

Ages Eligible for Study
-----------------
Minimum Age: 80 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sildenafil<br>50 mg sildenafil oral. One dose | Drug: Sildenafil<br>* 50 mg sildenafil, one dose<br>|
| Placebo Comparator: Placebo<br>Placebo pill. One dose | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Index | Cardiac Index measured by cardiac magnetic resonance imaging | 74 (plus/minus 17) minutes after drug administration |
Efficacy of Internet and Smartphone Application-delivered Tinnitus Retraining Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to prove the efficacy of the internet and smartphone application-delivered tinnitus retraining therapy (TRT).

Detailed Description
-----------------
to investigate the effect of TRT with minimized counseling

Official Title
-----------------
Efficacy of Internet and Smartphone Application-delivered TRT

Conditions
-----------------
Tinnitus

Intervention / Treatment
-----------------
* Drug: Ginkgo biloba
* Behavioral: modified TRT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic subjective tinnitus Exclusion Criteria: THI < 18

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ginkgo biloba only<br>control group Ginexin-F 80mg tablet will be given twice a day for 6 months. | Drug: Ginkgo biloba<br>* Ginexin-F 80mg tablet will be given twice a day for 6 months.<br>* Other names: Ginexin-F;|
| Experimental: Ginkgo biloba + modified TRT<br>experimental group modified TRT (tinnitus retraining therapy) using smartphone and web based materials will be added with Ginkgo biloba. Ginexin-F 80mg tablet will be given twice a day for 6 months. | Drug: Ginkgo biloba<br>* Ginexin-F 80mg tablet will be given twice a day for 6 months.<br>* Other names: Ginexin-F;Behavioral: modified TRT<br>* modified TRT (tinnitus retraining therapy) using smartphone and web based materials will be added with Ginkgo biloba. Ginexin-F 80mg tablet will be given twice a day for 6 months.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus Handicap Inventory (THI) | THI will be evaluated 6 months after TRT using smatrphone and web | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tinnitus, smartphone, Web
Minimally Invasive Aortic Root and Aorta surGery rEgistry

Study Overview
=================
Brief Summary
-----------------
Minimally invasive aortic valve (AV) surgery has become widely accepted alternative to standard sternotomy. Despite possible reduction in morbidity, this approach is not routinely performed for aortic surgery. Evidence exists, however, on safety of this approach together with promising results regarding its long-term durability. The MIRAGE Registry is aimed to collect and analyse the data from multiple aortic excellence centres and to analyse them in numerous clinical scenarios.

Official Title
-----------------
Multicentre Registry of Minimally Invasive Aorta and Aortic Root Surgeries in Patients With Aortic Aneurysms

Conditions
-----------------
Aortic Aneurysm, Thoracic

Intervention / Treatment
-----------------
* Procedure: Aortic Root Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: isolated, first time aortic root or aorta surgery Exclusion Criteria: active aortic valve endocarditis, redo surgery, acute type A dissection, and concomitant cardiac procedures.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| mini-David<br> | Procedure: Aortic Root Surgery<br>* First time, isolated, minimally invasive (mini-sternotomy, RALT) aortic root or aorta surgery<br>* Other names: Ascending Aorta Aneurysm Surgery, Aortoplasty, Supracoronary Replacement;|
| mini-Yacoub<br> | Procedure: Aortic Root Surgery<br>* First time, isolated, minimally invasive (mini-sternotomy, RALT) aortic root or aorta surgery<br>* Other names: Ascending Aorta Aneurysm Surgery, Aortoplasty, Supracoronary Replacement;|
| mini-Bentall<br> | Procedure: Aortic Root Surgery<br>* First time, isolated, minimally invasive (mini-sternotomy, RALT) aortic root or aorta surgery<br>* Other names: Ascending Aorta Aneurysm Surgery, Aortoplasty, Supracoronary Replacement;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early (in-hospital/30-day) mortality |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from reoperation |  | 5 years | 
| Long-term mortality |  | 5 years |