linjc16/ctgov huggingface dataset:
VascTrac Peripheral Arterial Disease (PAD) Study

Study Overview
=================
Brief Summary
-----------------
VascTrac is a mobile medical application that tracks users' physical activity levels in order to predict endovascular failure of patients with Peripheral Artery Disease.

Detailed Description
-----------------
VascTrac uses open-source software from Apple's ResearchKit to passively track physical activity levels of users who sign up. The goal is to predict post-intervention endovascular failure before it occurs. Currently, physicians have no way of knowing when procedures such as angioplasties fail; with VascTrac, researchers hope to find downward trends in physical activity that will predict and indicate endovascular failure. All users are assigned numbers and their medical data is securely coded, decreasing the risk of promulgation of personal information.

Official Title
-----------------
VascTrac PAD ResearchKit Study

Conditions
-----------------
Peripheral Artery Disease, Intermittent Claudication

Intervention / Treatment
-----------------
* Behavioral: Physical activity levels


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult, has iPhone 5s, can read English Exclusion Criteria: under 18 years

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 |
| --- | --- |
| Patients with PAD<br>Patients with PAD will be in 1 cohort and will have their physical activity levels closely monitored by researchers and physicians. | Behavioral: Physical activity levels<br>* Patients with severely low physical activity levels will be notified to consult their physician.<br>|
| Patients without PAD<br>Patients without PAD will be allowed to contribute their data to the application, but they will not be as closely monitored. | Behavioral: Physical activity levels<br>* Patients with severely low physical activity levels will be notified to consult their physician.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity | Participants will have their physical activity measured and recorded by the devices in Apple's Health application. | Two Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PAD
An Extension Study of ANAVEX2-73 in Patients With Mild to Moderate Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
This open label extension study is designed to provide continued access to ANAVEX 2-73 for eligible subjects with mild to moderate Alzheimer's Disease who have previously participated in the Anavex sponsored study ANAVEX2-73-002.

Official Title
-----------------
An Extension Study of ANAVEX2-73 in Patients With Mild to Moderate Alzheimer's Disease

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: ANAVEX2-73


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous exposure to ANAVEX2-73 via participation in Phase 2a Study of ANAVEX2-73 Adaptive-Trial-Design With Repeated Doses, MTD Finding, Pharmacodynamic and Bioavailability Evaluation in Patients With Mild to Moderate Alzheimer's Disease With a 12-Month Open Label Follow-Up Period (ANAVEX2-73-002) Exclusion Criteria: Have not previously participated Phase 2a Study of ANAVEX2-73 Adaptive-Trial-Design With Repeated Doses, MTD Finding, Pharmacodynamic and Bioavailability Evaluation in Patients With Mild to Moderate Alzheimer's Disease With a 12-Month Open Label Follow-Up Period (ANAVEX2-73-002)

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 85 Years

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

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: ANAVEX2-73 Oral as assigned in ANAVEX2-73-002<br> | Drug: ANAVEX2-73<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Safety | Up to 208 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score from MMSE (Mini-mental state examination score) | Exploratory Efficacy | Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, 169, 182, 195, 208 | 
| Score from ADCS-ADL (Alzheimer's Disease Co-operative Study - Activities of Daily Living Inventory) | Exploratory Efficacy | Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, 169, 182, 195, 208 | 
| HAM-D Score (Hamilton Psychiatric Rating Scale for Depression) | Exploratory Efficacy | Baseline; Weeks: 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, 169, 182, 195, 208 |
Assessment of Acute Renal Injury During Partial Nephrectomy Using Neutrophil Gelatinase-associated Lipocalin (NGAL): Prospective Comparative Study Between Open, Video-assisted Minilaparotomy, Laparoscopic, and Robotic-assisted Laparoscopic Surgery

Study Overview
=================
Brief Summary
-----------------
Urinary Neutrophil gelatinase associated lipocalin (NGAL) has been recently reported to be related with the degree of acute kidney injury. We are trying to analyze whether it is related with the grade of acute kiney injury after partial nephrectomy and there is any difference between the kinds of surgery.

Conditions
-----------------
the Patients With Partial Nephrectomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults patient more than 20 years old with ASA score 1-3 the patients who undergoing partial nephrectomy for the renal mass less than 7 cm Exclusion Criteria: the patient with previous history with renal surgery the patient with bilateral partial nephrectomy the patient with synchronous operation for other intraperitoneal surgery the renal mass more than 7 cm previous kinds of surgery is changed into other kinds due to bleeding, etc the patient with serum Cr level more than 1.4 mg/dl the patient who does not understand the consent form

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 |
| --- | --- |
| the patients with open partial nephrectomy<br>the adult patients with open partial nephrectomy | |
| laparoscopic<br>the adult patients with laparoscopic partial nephrectomy | |
| VAMS<br>the adult patients with VAMS partial nephrectomy | |
| robotic<br>the adult patients with robotic partial nephrectomy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The level of urinary NGAL | Analysis of correlation between the level of preoperative and postoperative urinary NGAL | changes from Preoperative, postop 3hr, 24hr, 48hrs after partial nephrectomy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute kidney injury, partial nephrectomy, biomarker
Pharmacotherapy and Intensive Treatment of Drug Abuse - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate desipramine and carbamazepine in reducing cocaine craving; increase outpatient treatment capacity and evaluate their incidence of psychiatric disorders.

Official Title
-----------------
Pharmacotherapy and Intensive Treatment of Drug Abuse

Conditions
-----------------
Cocaine-Related Disorders, Substance-Related Disorders

Intervention / Treatment
-----------------
* Drug: Carbamazepine


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug use |  |  | 
| Effectiveness of medication |  |  | 
| Level of pharm |  |  | 
| Retention |  |  | 
| Depression, anxiety |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
drug abuse
Comparison of Circular(Soave) and Heart-shaped Anastomosis in Hirschsprung's Disease: A Prospective Multicenter Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
Comparison of Circular(Soave)and Heart-shaped Anastomosis in Hirschsprung's disease.

Official Title
-----------------
Comparison of Circular(Soave) and Heart-shaped Anastomosis in Hirschsprung's Disease: A Prospective Multicenter Randomized Controlled Trial

Conditions
-----------------
Constipation

Intervention / Treatment
-----------------
* Procedure: Heart-shape anastomosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age<14 years Hirschsprung's disease diagnosed by biopsy Surgical indication Exclusion Criteria: Age>14 years Not Hirschsprung's disease Surgical contraindication

Ages Eligible for Study
-----------------
Maximum Age: 14 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: Circular Anastomosis<br> | Procedure: Heart-shape anastomosis<br>* a new operation approach for Hirschsprung disease<br>|
| Active Comparator: Heart-shaped Anastomosis<br> | Procedure: Heart-shape anastomosis<br>* a new operation approach for Hirschsprung disease<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative cure rate |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complication rate |  | two years |
To Investigate The Safety, Toleration And Pharmacokinetics Of Single Oral Doses Of PF-04531083 In Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate the safety, toleration and pharmacokinetics of single oral doses of PF-04531083 in healthy male subjects.

Official Title
-----------------
A Double Blind (3rd Party Open), Randomized, Placebo Controlled, Parallel Group, Dose Escalation Study To Investigate The Safety, Toleration And Pharmacokinetics Of Single Oral Doses Of PF-04531083 In Healthy Male Subjects

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: PF-04531083


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: young healthy male Exclusion Criteria: elderly unhealthy female

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pf-04531083<br>To Investigate The Safety, Toleration And Pharmacokinetics Of Single Oral Doses Of PF-04531083 In Healthy Male Subjects | Drug: PF-04531083<br>* solution. doses to be selected based upon safety/tolerability/PK at preceeding dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and toleration: adverse events, supine and standing vital sign measurements,telemetry, 12-lead ECGs, blood and urine safety tests |  | up to 48 hours | 
| Plasma: Cmax, Tmax, AUClast, AUCinf, AUC0-24, CL/F and t½ for PF-04531083 |  | 240 hours post dose | 
| Cmax, Tmax, AUClast, AUCinf and t½ for PF-04335882 |  | 240 hours post dose | 
| Urine: Aet (amount excreted in urine), Aet% and CLr (for selected doses dependent on the emerging pharmacokinetic profile of PF-04531083, PF-04335882 and O-desmethyl metabolite (PF-04959926))where t = 48 hours. |  | 240 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No secondary endpoints. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inflammatory pain
Longitudinal Registry of Endovascular Thoracoabdominal Aneurysms

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the long-term safety and performance of complex endovascular aneurysm repair by inclusion in a longitudinal registry

Detailed Description
-----------------
This is a Global, multicenter, prospective, observational, non-randomized, single-arm, open clinical study will evaluate the long term (i.e. >5 years) safety and efficacy of complex endovascular repair This study will enroll all patients treated with Fenestrated and Branched devices in Europe and Canada that follow all inclusion criteria and none of the exclusion criteria. The total duration of the study will be of approximately 7 years.

Official Title
-----------------
Longitudinal Registry of Endovascular Thoracoabdominal Aneurysms: Study of Fenestrated and Branched Stent Grafts in the Treatment of Aortic Aneurysms

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

Intervention / Treatment
-----------------
* Device: Endovascular Thoracoabdominal Aneurysm Repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient eligibility for enrolment shall be based on known information at the time of the procedure. Information obtained at a later date may contradict these criteria, but this will not be considered a deviation of the Study Plan. Inclusion criteria A patient is deemed suitable for inclusion in the study if the patient meets both of the following criteria: Patient requires endovascular repair of a thoracic, thoraco-abdominal or abdominal aortic or aorto-iliac aneurysm having morphology suitable for endovascular repair with complex endograft. Patients (or their legal representative for minor patients) who do not object to (oral non-objection declaration, and signed consent form) collection and transmission of his/her data. Exclusion Criteria: Patients are excluded from enrolment into the study if any of the following are true: Patients whose imaging follow-up is impossible, i.e. patients who are not able to send their follow up CT scans or Duplex US

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Endovascular Thoracoabdominal Aneurysm Repair|Standard of care, treatment of thoracoabdominal aneurysms using endovascular techiniques.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Longterm Aneurysm Related Mortality | Death attributed to aneurysm rupture | 7 years |
Dose-ranging Study of Ramosetron for the Prevention of Nausea and Vomiting After Gynecologic Laparoscopic Surgery

Study Overview
=================
Brief Summary
-----------------
Many patients receiving opioid based analgesia after gynecologic laparoscopic surgery experience postoperative nausea and vomiting (PONV) despite prophylaxis and treatment with HT3 receptor antagonists. Although a high dose of ramosetron can cause adverse effects such as headache or dizziness, the minimal effective dose of ramosetron in a high-risk patients is unknown. The aim of this study is to determine the effective dose of ramosetron for prophylaxis of PONV in a high-risk patients receiving intravenous opioid-based patient-controlled analgesia after gynecological laparoscopic surgery.

Conditions
-----------------
Postoperative Nausea and Vomiting

Intervention / Treatment
-----------------
* Drug: ramosetron 0.3
* Drug: ramosetron 0.45
* Drug: ramosetron 0.6


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient between 20 and 70 of age with ASA physical status Ⅰ-Ⅱ patient scheduled for elective gynecological laparoscopic surgery. Exclusion Criteria: hepatorenal disease BMI > 35 kg/m2 allergy to ramosetron gastrointestinal disease vomiting within 24h administration of antiemetics or opioids within 24h QT prolongation (QTc > 440ms) pregnant problem with communication

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ramosetron 0.3<br> | Drug: ramosetron 0.3<br>* The ramosetron 0.3 group receives ramosetron 0.3 mg at the end of surgery.<br>|
| Active Comparator: ramosetron 0.45<br> | Drug: ramosetron 0.45<br>* The ramosetron 0.45 group receives ramosetron 0.45 mg at the end of surgery.<br>|
| Active Comparator: ramosetron 0.6<br> | Drug: ramosetron 0.6<br>* The ramosetron 0.6 group receives ramosetron 0.6 mg at the end of surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative nausea and vomiting | incidence of nausea and vomiting during the first 48 h after surgery | within 48h after surgery |
Satisfaction of Patient With Anaphylaxis in the Use of a Medical Device

Study Overview
=================
Brief Summary
-----------------
Through several questionaries the investigators will measure the satisfaction of patients diagnosed with anaphylaxis in the use of a medical device for the adrenaline autoinjector, a smart case for an epinephrine autoinjector connected via Bluetooth to a mobile application.

Official Title
-----------------
Randomized, Cross-over, Open, Unicentric Trial Evaluating Satisfaction With the Use of a Medical Device for the Epinephrine Auto-injector in Patients With Anaphylaxis

Conditions
-----------------
Anaphylaxis

Intervention / Treatment
-----------------
* Behavioral: Device: Anapphylaxis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years old or above Patients diagnosed with Anaphylaxis and an epinephrine auto-injector prescribed Patients with a smartphone Patients who signed the informed consent Exclusion Criteria: Patients who have not signed the informed consent Patients with some limitations for understanding or following correctly the trial procedures Pregnant or nursing women

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: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: epinephrine auto-injector<br>3 months using the epinephrine auto-injector alone, and after that 3 more months using the epinephrine auto-injector + medical device | |
| Experimental: epinephrine auto-injector + medical device<br>Device: Anapphylaxis is a medical device with a case for an epinephrine autoinjector that connects via Bluetooth to a mobile application 3 months using the epinephrine auto-injector + medical device , and after that 3 more months using the epinephrine auto-injector alone | Behavioral: Device: Anapphylaxis<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction through a questionnaire in the use of the medical device |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical device safety | Adverse events related to the medical device | 3 months | 
| Patient Adherence to the medical device through a questionnaire |  | 3 months |