linjc16/ctgov huggingface dataset:
Longterm Follow-up After Remote Ischemic Preconditioning for Prevention of Contrast-induced Nephropathy

Study Overview
=================
Brief Summary
-----------------
Remote ischemic preconditioning reduces the incidence of contrast-induced acute kidney injury in patients undergoing elective coronary angiography. This study was designed to acquire long-term data of initially randomized patients in the RenPro Trial.

Detailed Description
-----------------
Data of the RenPro Trial has been already published. In the present study data of longterm follow up are collected.

Official Title
-----------------
Remote Preconditioning for Contrast-Induced Acute Kidney Injury: Long-Term Follow up (RenPro Longterm)

Conditions
-----------------
Impaired Renal Function

Intervention / Treatment
-----------------
* Other: Ischemic preconditioning


Participation Criteria
=================
Eligibility Criteria
-----------------
All patients who participated to the RenPro trial

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 |
| --- | --- |
| Subjects with impaired renal function<br>Subjects with baseline impaired renal function undergoing cardiac catheterization with contrast-medium exposure | Other: Ischemic preconditioning<br>* Subjects received ischemic preconditioning previous to cardiac catheterization<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACCE | Major Adverse Cardiac and Cerebrovascular Events (Combined primary endpoint): All-cause mortality, cardiovascular mortality, rehospitalization, stroke, myocardial infarction, hemodialysis | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function | changes of serum creatinine, eGFR, NGAL and cystatin C compared to baseline in both groups. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
preconditioning, contrast-induced acute kidney injury, renal faliure
Renal Regional Oxygen Saturation During Transcatheter Aortic Valve Implantation

Study Overview
=================
Brief Summary
-----------------
This prospective observational study evaluates the association of peri-procedural changes in renal regional oxygen saturation and post-procedural acute kidney injury in patients undergoing transcatheter aortic valve implantation.

Detailed Description
-----------------
This prospective observational cohort study evaluated the association of renal regional oxygen saturation, measured during transcatheter aortic valve implantation, and post-procedural acute kidney injury. Renal regional oxygen saturation is measured using near-infrared spectroscopy on the skin surface over the kidneys.

Official Title
-----------------
Association of Renal Regional Oxygen Saturation and Postprocedural Acute Kidney Injury in Patients Undergoing Transcatheter Aortic Valve Implantation

Conditions
-----------------
Kidney Injury, Acute, Transcatheter Aortic Valve Implantation

Intervention / Treatment
-----------------
* Device: Regional oxygen saturation monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (>= 20 years old) undergoing transcatheter (transfemoral) aortic valve implantation Exclusion Criteria: Emergent procedure Pre-procedural severe renal impairment (eGFR < 30 mL/min/1.73 m2) Pre-procedural hemodialysis Distance from skin to renal capsule > 4 cm Pre-procedural mechanical ventilation Refuse to participate

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Renal regional oxygen saturation<br>Renal regional oxygen saturation is measured by using near infrared spectroscopy during transcatheter aortic valve implantation | Device: Regional oxygen saturation monitoring<br>* Regional oxygen saturation of kidney is monitored using near infrared spectroscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute kidney injury | increase in serum creatinine compared with baseline or reduced urine output | during 7 days post-TAVI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite complication | stroke, delirium, acute MI, heart failure, new or worsening arrhythmia, mechanical ventilation over 24 h, length of ICU stay, hospital stay, mortality | during 7 days post-TAVI or until discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
renal regional oxygen saturation, acute kidney injury, transcatheter aortic valve implantation
Evaluation of the Gastric Tube Guide to Place Orogastric Tubes

Study Overview
=================
Brief Summary
-----------------
A randomized controlled prospective study of orogastric tube placement with the Gastric Tube Guide vs conventional placement.

Official Title
-----------------
Evaluation of the Gastric Tube Guide to Place Orogastric Tubes: : A Prospective, Randomized Trial

Conditions
-----------------
Orogastric Tube Placement

Intervention / Treatment
-----------------
* Device: Gastric Tube Guide
* Device: Conventional placement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 Years No concurrent participation in another study Capacity to consent Present written informed consent of the research participant Elective surgery in general anesthesia Required orogastric intubation Exclusion Criteria: Existing pregnancy Emergency patients Preexisting pathological findings in the mouth, pharynx or esophagus

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 |
| --- | --- |
| Experimental: GTG<br>Gastric tube placement using the Gastric Tube Guide | Device: Gastric Tube Guide<br> <br> |
| Other: Conventional<br>Gastric tube placement using a conventional method, according to local protocol. | Device: Conventional placement<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success | Overall Success after 180 seconds. Yes if a gastric tube was placed in time, no if not | 180 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attempts | Number of attempts that were necessary to place a gastric tube within 180 seconds | 180 seconds | 
| Time | Total time needed for gastric tube placement in seconds | 180 seconds | 
| Complications | Complications such as Bleeding, tooth damage, malposition (Scale yes or no) | 180 seconds | 
| Postoperative comfort | Postoperative comfort is assessed using the postoperative section of the core data set anaesthesia from the German Society of Anaesthesiology and Intensive Care Medicine | 24 hours |
A European Post-Authorisation Observational Study (Registry) of Patients With Chronic Adrenal Insufficiency (AI)

Study Overview
=================
Brief Summary
-----------------
As a post-approval requirement of the European Medicines Agency, this European patient post authorization safety study is an observational study being conducted to monitor the safety of long-term treatment with Plenadren and other glucocorticoid replacement therapies in routine clinical practice in patients with chronic adrenal insufficiency (primary or secondary).

Official Title
-----------------
A European, Multi-Centre, Multi-Country, Post-Authorisation, Observational Study (Registry) of Patients With Chronic Adrenal Insufficiency (AI)

Conditions
-----------------
Chronic Adrenal Insufficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of chronic adrenal insufficiency Written informed consent/assent in compliance with applicable country-specific and local regulations Exclusion Criteria: Participation in an interventional clinical trial
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Plenadren<br>Modified release hydrocortisone | |
| Other Glucocorticoid Replacement Therapy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of intercurrent illness | Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI | approximately 10 years | 
| Incidence of adrenal crisis | Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI | approximately 10 years | 
| Incidence of serious adverse events | Monitor the safety of long-term treatment with PLENADREN and other glucocorticoid replacement therapies in patients with chronic AI | approximately 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adrenal insufficiency, DuoCort, Congenital adrenal hyperplasia (CAH), Modified release, Hydrocortisone
Bone Effects of Teriparatide Following Alendronate

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effect of 24 months of treatment with once daily teriparatide injection (recombinant human PTH [1-34]) 20 micrograms on bone histomorphometry and architecture. Patients will include postmenopausal, osteoporotic women who have been treated long term (at least 36 months) with alendronate, as well as postmenopausal, osteoporotic women who have never been treated for osteoporosis.

Official Title
-----------------
Bone Effects of Subcutaneous Teriparatide Following Discontinuation of Alendronate Treatment in Postmenopausal Women With Osteoporosis

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: teriparatide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Osteoporosis: Pretreated patients currently osteoporotic or osteopenic. Treatment-naive patients currently osteoporotic Pretreated patients will have had at least 36 months of treatment with alendronate Na 10 mg/day or 70 mg/week. Treatment-naive patients will have no significant osteoporosis treatment in the prior 36 months, as assessed by the investigator Exclusion Criteria: History of bone metabolic diseases, Paget's disease, renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis, hyperparathyroidism (uncorrected), and intestinal malabsorption. History of malignant neoplasms in the prior 5 years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. If malignant neoplasm was ever diagnosed, patient must presently be free of disease.

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

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

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 |
| --- |
|Drug: teriparatide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| conventional histomorphometric parameters (bone turnover, bone formation rate, and bone volume) and microdamage accumulation from iliac crest biopsies. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMD (DXA, Holoc Delphi A),Biochemical markers of bone metabolism,3-D bone morphology by high resolution quantitative Computed Tomography (QCT) |  |  |
The Impact of Video Information on Preoperative Anxiety in Interventional Cardiology Patients.

Study Overview
=================
Brief Summary
-----------------
This study evaluates the impact of educative videos on anxiety for patients entering hospital for cardiology intervention

Official Title
-----------------
The Impact of Video Information on Preoperative Anxiety in Interventional Cardiology Patients.

Conditions
-----------------
Coronary Artery Disease, Atrial Fibrillation, Atrial Flutter

Intervention / Treatment
-----------------
* Device: educational video


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient entering hospitalisation in cardiology department for a cardiology intervention. Exclusion Criteria: protected person.

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 |
| --- | --- |
| video<br>patients who enjoyed an educational video | Device: educational video<br>* educational video before intervention<br>|
| control<br>patients who didn't enjoy any educational video | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anxiety | anxiety measured with STAI Y-A questionnaire | 1 year |
Study of orBec® With Prednisone Therapy in the Treatment of Patients With Graft Versus Host Disease (GVHD)

Study Overview
=================
Brief Summary
-----------------
Use of an oral topically-active glucocorticoid with limited side effects will control the gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.

Official Title
-----------------
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of orBec® (Oral Beclomethasone 17,21-Dipropionate)in Conjunction With Ten Days of High-Dose Prednisone Therapy in the Treatment of Patients With Gastrointestinal GVHD

Conditions
-----------------
Acute Gastrointestinal Graft vs Host Disease

Intervention / Treatment
-----------------
* Drug: oral beclomethasone 17,21-dipropionate
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Receipt of allogeneic hematopoietic cell transplant Diagnosis of GI graft vs. host disease (GVHD) No GI infection Must be able to swallow tablets Must be able to read and understand informed consent Adequate birth control methods for the duration of the study Exclusion Criteria: Significant Skin GVHD Liver GVHD Persistent vomiting HIV positive Pregnancy/lactation

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: orBec®<br>Investigational drug | Drug: oral beclomethasone 17,21-dipropionate<br>* Two tablets QID for 50 days<br>* Other names: BDP;|
| Placebo Comparator: Placebo<br>Control | Drug: Placebo<br>* Two tablets QID for 50 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Proportion of Subjects With GVHD Treatment Failure | The primary endpoint is the occurrence (yes, no) during the 80-day study period of GVHD treatment failure defined as use of prednisone or equivalent IV corticosteroids at doses higher than stated in the protocol, or use of any additional other glucocorticoid (including unblinded BDP) or addition of other immunosuppressant medications, in response to uncontrolled signs or symptoms of GVHD | Day 80 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Exposure to Prednisone |  | Day 80 | 
| Survival Status |  | Day 200 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BDP, orBec, GVHD, beclomethasone dipropionate, bone marrow transplant, hematopoietic cell transplant, HCT, stem cell transplant, marrow transplant, SCT, beclomethasone 17,21-dipropionate
Chronic Thalidomide Administration in Patients Undergoing Chemoembolization for Unresectable Hepatocellular Cancer

Study Overview
=================
Brief Summary
-----------------
This is a clinical trial to test the safety and efficacy of the drug thalidomide in combination with a procedure called chemoembolization in patients with inoperable liver cancer. Chemoembolization is the process by which chemotherapy is instilled directly into the blood vessels feeding the tumor, so that the blood vessels feeding the tumor may be blocked. Chemoembolization consists of two separate procedures. It will be done by infusing chemotherapy with the drug doxorubicin through the hepatic artery into the liver and then by infusing collagen to cut off the blood supply to the tumor. A catheter will be inserted at various times to allow for these infusions. The objectives are to investigate the feasibility and potential activity of chronic administration of thalidomide in patients with unresectable hepatocellular cancer who receive chemoembolization to predominant tumor masses. The toxicity of thalidomide in these patients will be evaluated. Overall safety will also be assessed. Serum levels of angiogenic cytokines such as VEGF, bFGF, and TNF-a, that are believed to have a role in hepatocellular carcinoma, will be collected.

Conditions
-----------------
Liver Cancer

Intervention / Treatment
-----------------
* Drug: thalidomide
* Procedure: chemoembolization with doxorubicin/collagen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with unresectable hepatocellular carcinoma. MRI of liver must show discrete tumor nodules. Lesions on angiography must be hypervascular. Patient must have the following minimum labs: ANC> 1200/mm3; Hemoglobin > 8 mg/dl; platelets > 50,000 mm3; hepatic transaminases < 5x normal; bilirubin < 3.0 mg/dl; and creatinine < 1.5 mg/dl. ECOG performance status > 2. No history of prior chemotherapy or biologic therapy for hepatocellular carcinoma. No other history of malignancy other than curatively resected basal cell carcinoma of the skin or carcinoma in situ of the cervix. Patients must not be pregnant or lactating. Sexually active men and women of childbearing age must use adequate contraception. All patients must understand the potential for severe birth defects with thalidomide and must be able to follow instructions to avoid conception while taking thalidomide

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: thalidomide|nan|
|Procedure: chemoembolization with doxorubicin/collagen|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Study of the Prevalence of Headache in Epileptic Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the prevalence, characteristics and classification of headaches in epileptic patients.

Detailed Description
-----------------
Headache is often ignored as a symptom of epileptic seizures. The purpose of this survey is to investigate the prevalence, characteristics and classification of seizure-associated headaches and non-seizure-associated headaches in epileptic patients in Korea, according the criteria of the International Headache Society 2004. In this survey, 577 consecutive patients with a recent diagnosis of epilepsy are interviewed by questionnaire about headaches associated with epileptic seizures. It involves questions about headache in general, localization, severity, duration and frequency, as well as headache associated with seizures, and about patient's family history. This Observational study does not involve the administration of any drugs.

Official Title
-----------------
Headache in Epileptic Patients

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Other: A structured questionnaire for seizure-related headache


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a recent diagnosis epilepsy Able to describe their symptoms by themselves Have had at least 2 episodes of seizures during the previous year Have had at least 1 headache during the previous year Exclusion Criteria: Well-controlled epileptic patients taking anti-epileptic medications

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 85 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 |
| --- | --- |
| 001<br> | Other: A structured questionnaire for seizure-related headache<br>* A structured questionnaire for seizure-related headache<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of seizure-related headache among epilepsy patients and its classification |  | At first visit (This study is cross-sectional) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pain intensity of seizure-related headache |  | At 1st visit | 
| The frequency of seizure-related headache |  | At 1st visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Seizure, Epilepsy, Headache