linjc16/ctgov huggingface dataset:
AcQMap® US Registry of Procedural and Long-term Clinical Outcomes (Discover-US)

Study Overview
=================
Brief Summary
-----------------
AcQMap Registry is an observation study

Detailed Description
-----------------
AcQMap Registry is an observational, prospective, multi-center, open-label registry designed to provide clinical data regarding the commercial, real-life experience with the diagnostic AcQMap System.

Official Title
-----------------
AcQMap® US Registry of Procedural and Long-term Clinical Outcomes (Discover-US)

Conditions
-----------------
Ablation of Arrhythmia's

Intervention / Treatment
-----------------
* Device: AcQMap System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female 18 years of age or older. Currently scheduled for an ablation of an arrhythmia utilizing the diagnostic AcQMap System. Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study. Willing and able to give written informed consent. Exclusion Criteria: In the opinion of the Investigator, any known contraindications to an ablation procedure. Current enrollment in any study protocol sponsored by Acutus Medical. Any other condition that, in the judgment of the investigator, makes the participant a poor candidate for this procedure, the study, or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, extensive travel away from the research center, etc.).

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: AcQMap System|To evaluate procedural and long-term outcomes when using the diagnostic AcQMap System as an imaging and mapping system for ablation of arrhythmias in accordance with the Instructions for Use (IFU).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Ablation Outcomes | Number of participants who had termination of ablated arrhythmia's to Sinus Rhythm or another arrhythmia within 12 hours post ablation procedure with or without electrical or pharmacological cardioversion | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term Outcome | First-procedure freedom from any arrhythmia on and/or off AADs, throughout the follow-up period, excluding events in the initial 90 days following the procedure (blanking period). | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ablation, atrial arrhythmia
A Study To Understand How The Body Reacts To A Low Dose Of PF-06427878 When Given In A Vein To Healthy, Adult, Males

Study Overview
=================
Brief Summary
-----------------
To determine how the body reacts to a low dose of PF-06427878 when given in a vein over 30 minutes to healthy, adult, males.

Official Title
-----------------
A Phase 1, Non-Randomized, Open-Label, Single-Dose, Single Period Study With Non-Pharmacologically Active Dose Of Pf-06427878 To Characterize Pharmacokinetics Following Intravenous Administration In Healthy, Adult, Male Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: PF-06427878


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects between 18-55 years of age BMI of 17.5-30.5 kg/m2 Exclusion Criteria: History of drug or alcohol abuse within 2 years of screening Subjects without suitable veins for multiple venipuncture/cannulation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-06427878<br> | Drug: PF-06427878<br>* Intravenous, 100 micrograms, single dose, 30 minute infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Plasma Curve From Time Zero to Last Quantifiable Concentration (AUClast) |  | Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5 | 
| Area under the Plasma Concentration-Time Curve From Time Zero extrapolated to Infinite Time (AUCinf) |  | Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5 | 
| Maximum Observed Plasma Concentration (Cmax) |  | Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5 | 
| Plasma Terminal Elimination Half Life (t1/2) |  | Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5 | 
| Plasma Systemic Clearance (CL) |  | Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5 | 
| Plasma Volume of Distribution at Steady State (Vss) |  | Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of unchanged drug excreted in urine from time 0 to 12.5 hours (Ae12.5) |  | Day 1 Hr 0 to 12.5 | 
| Percent of dose excreted in urine as unchanged drug from time zero to 12.5 hours (Ae12.5%) |  | Day 1 Hr 0 to 12.5 | 
| Renal clearance (CLr) |  | Day 1 Hr 0 to 12.5 |
Pilot Study: Urea Cycle Disorders Practice Patterns and Outcomes Assessment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if patients participating in The Longitudinal Study of Urea Cycle Disorders are different than participants in the Urea Cycles Disorders Consortium (UCDC) Rare Diseases Clinical Research Network (RDCRN) Contact Registry and to determine if patients are a good source of medical information.

Detailed Description
-----------------
Participants enrolled in the RDCRN UCDC Contact Registry will receive an email inviting them to participate in the study. Interested participants will be directed to the informed consent document. After agreeing to participate, participants will be directed to the study web portal. The study web portal will be developed and maintained by the Data Management and Coordinating Center at the University of South Florida (USF). Participants will complete several questionnaires about their urea cycle disorder including diagnosis and treatment information and quality of life.

Official Title
-----------------
Pilot Study: Urea Cycle Disorders Practice Patterns and Outcomes Assessment

Conditions
-----------------
Urea Cycle Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrollment in UCDC RDCRN Contact Registry Patient reported diagnosis of one of the eight UCDs or UCD diagnosis highly likely/pending. Exclusion Criteria: Cases of hyperammonemia caused by an organic acidemia, lysinuric protein intolerance, mitochondrial disorders, congenital lactic acidemia, fatty acid oxidation defects and primary liver disease. Individuals with rare and unrelated serious comorbidities, e.g., Down syndrome, intraventricular hemorrhage in the newborn period, and extreme low birth weight (<1,500 grams). Inability to provide informed consent and complete surveys
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 |
| --- | --- | --- |
| Test the feasibility of collecting survey data from the UCDC Contact Registry | Patient-reported survey data will be reviewed for accuracy and feasibility as a reliable data source. | Up to one year from study activation. | 
| Assess patient reported outcomes on urea cycle relevant dimensions (applied cognition & subjective well-being). | The PROMIS website will be used to assess the accuracy and completeness of patient reported outcomes on urea cycle relevant dimensions. | Up to one year from study activation. | 
| Validate data on treatment setting (team and organization) and management (diet, pharmacologic management, transplantation) | Patient-reported survey data will be linked with research data collected in clinic for the same patients to validate patient-reported data on treatment setting and disease management. | Up to one year from study activation. |
Prolongation of Progesterone Supplementation in Antagonist Cycles and Pregnancy Outcomes

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the effect of the prolongation of luteal support on the ongoing pregnancy rate (beyond 12 weeks of gestation )in recFSH/GnRH antagonist cycles.

Official Title
-----------------
The Effect of Progesterone Supplementation During Early Gestations in Patients Treated With Rec FSH/GnRH Antagonist:a Randomized Controlled Trial

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: progesterone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age equal or less than 39 Body mass index between 18-29 kg/m2 Presence of both ovaries Basal hormonal values on day 2 of the cycle Embryotransfer day3 or day5 1 to 3 cycles Exclusion Criteria: Endometriosis stage 3 Polycystic ovarian syndrome Frozen or testicular sperm

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stop progesterone<br> | Drug: progesterone<br>* duration<br>* Other names: utrogestan;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ongoing pregnancy rate |  | up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antagonist, progesterone, rec FSH, IVF, pregnancy
Model 4968 CAPTURE EPI® STERIOD-ELUTING BIPOLAR EPICARDIAL PACING LEAD Post-approval Study

Study Overview
=================
Brief Summary
-----------------
The Medtronic CapSure Epi Lead Post-approval Study will assess long-term safety of the 4968 lead. This study is part of the Medtronic System Longevity Study.

Detailed Description
-----------------
The Medtronic CapSure Epi Lead Post-approval Study is being conducted as part of the requirements to satisfy the PMA conditions of approval for the Model 4968 lead. 100 subjects (adult and pediatric) with a 4968 lead will be followed for a minimum of five years to assess the long-term safety of the leads.

Official Title
-----------------
Medtronic Model 4968 CapSure Epi® Steroid-Eluting Bipolar Epicardial Pacing Lead Post-approval Study

Conditions
-----------------
Arrhythmia, Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of written informed consent and/or authorization for access to and use of health information by subjects or appropriate legal guardians as required by an institution's Investigational Review Board, Medical Ethics Board, or Research Ethics Board Availability of implant, follow-up, and product-related event data Implanted with a Model 4968 Capsure Epi Lead Exclusion Criteria: Subjects receiving an implant of a Medtronic lead at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant Subjects who are, or will be inaccessible for follow-up at a 4968 Post-approval study center Subjects implanted with a Medtronic cardiac therapy device whose predetermined enrollment limit for that specific product has been exceeded Subjects with exclusion criteria required by local law
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 |
| --- | --- | --- |
| Survival Probability of the Model 4968 Lead Based on Lead-related Complications | The survival analysis takes into account: Enrolled participants, lead follow-up time, and adjudicated lead related complications. The life-table method was used to analyze lead survival probability. | The requirement to satisfy the PMA condition of Approval of model 4968 was to have 100 participants followed for a minimum of 5 years to assess the long-term safety. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epicardial, Pacing Lead
T Wave Alternans in Hemodialysis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the hemodialysis procedure changes the risk for cardiac arrest in patients.

Detailed Description
-----------------
One-third to one-quarter of hemodialysis patients die of sudden cardiac death (SCD). The hemodialysis procedure may theoretically increase the risk of SCD. This study uses T wave alternans, a noninvasive marker of SCD, to objectively determine whether the hemodialysis procedure alters the risk of SCD in hemodialysis patients.

Official Title
-----------------
Pilot Study of a Noninvasive Predictor of Sudden Cardiac Death in Hemodialysis Patients

Conditions
-----------------
End Stage Renal Disease, Coronary Heart Disease, Congestive Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Normal sinus rhythm Exclusion Criteria: Inability to give written informed consent Active cardiac ischemia Pacemaker Inability to perform a brief walking treadmill test

Ages Eligible for Study
-----------------
Minimum Age: 18 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
-----------------
hemodialysis, sudden cardiac death
Investigation of Popular Recovery Techniques for Ultramarathon Recovery

Study Overview
=================
Brief Summary
-----------------
The study is a randomized clinical trial examining the effectiveness of massage and intermittent pneumatic compression on recovery from a 161-km ultramarathon.

Detailed Description
-----------------
The study is a randomized clinical trial examining the effectiveness of massage and intermittent pneumatic compression on recovery from a 161-km ultramarathon. Participants of the 2015 161-km Western States Endurance Run were randomized to a 20-minute post-race intervention of massage, intermittent pneumatic compression or supine rest. Each subject completed two 400 m runs at maximum speed before the race, and on days 3 and 5 after the race, and also provided muscle pain and soreness ratings and overall muscular fatigue scores before and for 7 days after the race.

Official Title
-----------------
Investigation of Popular Recovery Techniques for Ultramarathon Recovery

Conditions
-----------------
Musculoskeletal Pain

Intervention / Treatment
-----------------
* Device: intermittent pneumatic compression
* Procedure: massage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Entry in the Western States Endurance Run Exclusion Criteria: Failure to finish race

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>20 minutes of supine rest | |
| Active Comparator: Intermittent pneumatic compression<br>20 minutes of intermittent pneumatic compression | Device: intermittent pneumatic compression<br>* 20 minutes of intermittent pneumatic compression to lower extremities<br>|
| Active Comparator: Massage<br>20 minutes of massage therapy | Procedure: massage<br>* 20 minutes of massage to lower extremities<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 400 m run time | self-timed 400 m run as fast as possible | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower body muscle pain and soreness rating | Subjective rating of lower body muscle pain and soreness on 10-point Likert scale | 5 days | 
| Overall muscular fatigue score | Subjective rating of overall muscular fatigue on a 12-cm visual analog scale | 5 days |
Laparascopic vs. Laparotomy Management of Neonatal Duodenal Atresia

Study Overview
=================
Brief Summary
-----------------
Congenital duodenal atresia is a common cause of neonatal obstruction affecting 1 in 5000-10000 neonates. Laparoscopic management of this malformation is becoming increasingly common. However, few comparative studies exist and are often monocentric including few patients. This study will be multicentric, international and comparative to determine the place of laparoscopic surgery in the management of congenital duodenal atresia.

Official Title
-----------------
Laparascopic vs. Laparotomy Management of Neonatal Duodenal Atresia

Conditions
-----------------
Congenital Duodenal Atresia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Minor subject Subject having undergone neonatal surgery for congenital duodenal atresia or stenosis in the different participating centers between January 2009 and December 2019 Subject (and/or his/her parental authority) who has not expressed, after information, his/her opposition to the reuse of his/her data for the purpose of this research Criteria for non-inclusion: Subject (and/or his/her parental authority) who has indicated, after information, his/her opposition to the re-use of his/her data for the purposes of this research Conversion linked to a renunciation of the surgeon, procedure not started (optical introduction, unfeasibility by the surgeon due to lack of experience or technical impossibility)

Ages Eligible for Study
-----------------
Maximum Age: 17 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 |
| --- | --- | --- |
| rate of complications |  | 3 months after laparoscopic surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Congenital duodenal atresia, Neonatal obstruction, Laparascopic, Laparotomy, Neonatal duodenal atresia
Outcome of Pancreatic Stump Closure Following Resection of Tumors of the Head of the Pancreas.

Study Overview
=================
Brief Summary
-----------------
Chart review evaluating outcome of patients in whom following resection of a tumor involving the head of the pancreas no anastomosis of the pancreatic stump was done to the gastrointestinal tract.

Official Title
-----------------
Retrospective Chart Review on the Association of Pancreaticoduodenectomy Without Pancreatic-Gastrointestinal Anastomosis to Perioperative Morbidity and Mortality

Conditions
-----------------
Pancreatic Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically proven carcinoma of the head of pancreas or other periampullary carcinoma treated by pancreaticoduodenectomy. Exclusion Criteria: Patients undergoing pancreaticoduodenectomy for other indications (i.e. trauma) Charts not available for review.
Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |