linjc16/ctgov huggingface dataset:
Sentinel Low Risk Registry

Study Overview
=================
Brief Summary
-----------------
This registry is designed to quantify embolic debris capture rate in patients at low surgical risk treated with the Sentinel System during TAVI.

Detailed Description
-----------------
The SENTINEL-LIR Study is a multicenter, prospective registry to observe rate and type of debris capture in subjects at low surgical risk undergoing TAVI to demonstrate the positive effects of the use of the Sentinel System. Histopathology of captured debris from the Sentinel System will be analyzed. The primary objective is to determine the presence or absence of particles of 7 discreet tissue types: acute thrombus (with or without associated tissue/foreign material), organizing thrombus, valve tissue, arterial wall/necrotic core, calcification, foreign material, and myocardium. Morphometric assessment of the debris (sizes >150 m, >500 m, and >1,000 m). Patients will be screened for inclusion and exclusion criteria and documents which will have been reviewed and approved by the local Ethics Committee or regulatory authority prior to undergoing any study related exams or procedures. Fifty (50) subjects will be enrolled in the study from an estimated 6 different sites.

Official Title
-----------------
Cerebral Protection of Acute Embolic Burden During Transcatheter Aortic Valve Implantation in Low Risk Patients

Conditions
-----------------
Aortic Valve Stenosis

Intervention / Treatment
-----------------
* Device: Sentinel Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe symptomatic aortic valve stenosis Planned use of Sentinel System Subject planned for transfemoral TAVI with valve system approved by U.S. FDA for low risk patients STS-PROM score of less than 4% and agreement by Heart Team that patients meet criteria for low surgical risk Exclusion Criteria: Current or recent cerebrovascular accident (stroke, TIA) <6 months Transapical, direct aortic or subclavian TAVI access Carotid stenting or endarterectomy in last 6 weeks Prior aortic valve replacement Concomitant procedure with TAVI such as CABG, PCI, etc.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Sentinel Device|Sentinel Device used during TAVI in a Low Risk Patient|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The SENTINEL-LIR Study | To determine the incidence and type of debris capture in SENTINEL devices deployed during TAVI in patients at low surgical risk | 12 months |
Timing of Intrauterine Insemination (IUI) 24 or 48 Hours After Spontaneous Luteinizing Hormone (LH) Peak

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to prospectively evaluate whether performing an intra-uterine insemination 24 hours after the spontaneous LH peak may result in significantly higher ongoing pregnancy rates compared to 48 hours.

Official Title
-----------------
Timing of IUI 24 or 48 Hours After Spontaneous LH Peak: a Randomised Controlled Trial

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Procedure: intra-uterine insemination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: below 39 years of age on the day of LH peak donor semen natural cycle (without CC) cycle with less than 3 follicles reaching 15 mm of diameter or more. with basal hormonal values of progesterone ( < 1,2 ng/dl) Exclusion Criteria: The patients excluded are women who underwent more than 6 intrauterine inseminations, with tubal infertility

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>intrauterine insemination after 24 hours | Procedure: intra-uterine insemination<br>* Artificial insemination is the process by which sperm is placed into the reproductive tract of a female for the purpose of impregnating the female by using means other than sexual intercourse or natural insemination.<br>* Other names: no other interventions;|
| Active Comparator: Control group<br>intrauterine insemination after 48 hours | Procedure: intra-uterine insemination<br>* Artificial insemination is the process by which sperm is placed into the reproductive tract of a female for the purpose of impregnating the female by using means other than sexual intercourse or natural insemination.<br>* Other names: no other interventions;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rate |  | end of 2013 (up to 2 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| live birth rate |  | end of 2013 (up to 2 years) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
insemination, donor sperm, natural cycle
FAAH Availability in Psychiatric Disorders: A PET Study

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to examine Fatty Acid Amide Hydrolase (FAAH) availability in humans, including healthy individuals and across a spectrum of psychiatric disorders in which alterations in the endocannabinoid system are observed.

Detailed Description
-----------------
This study involves in vivo examination of FAAH availability, implicated both in the pathophysiology and therapeutics of disorders including PTSD, substance use disorders (e.g., alcohol use disorder, cannabis/cannabinoid use disorder, nicotine use disorder), psychotic disorders including schizophrenia, and mood disorders. The endocannabinoid system is a neuromodulatory system that has been implicated across a wide range of psychiatric disorders and may be implicated in the regulation of mood, appetitive behaviors, sleep, and cognition. Thus, alterations in the ECS have wide ranging implications. Finally, the ECS is being explored as a novel therapeutic target for several psychiatric disorders. Additionally, the test/retest reliability of the radiotracer, [11C]MK-3168, will be studied in up to 10 healthy control individuals.

Official Title
-----------------
FAAH Availability in Psychiatric Disorders: A PET Study

Conditions
-----------------
Post Traumatic Stress Disorder, Alcohol Use Disorder, Psychosis

Intervention / Treatment
-----------------
* Drug: [11C]MK-3168


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between the ages of 18 and 65 years, inclusive Good physical health as determined by history, physical and laboratory examinations, ECG, and vital signs PTSD Inclusion Criteria: Diagnosis of Post-Traumatic Stress Disorder AUD Inclusion Criteria: Diagnosis of Alcohol Use Disorder Psychosis Inclusion Criteria: Diagnosis of psychotic disorder such as Schizophrenia, Schizoaffective disorder Exclusion Criteria: Presence of ferromagnetic metal in the body or heart pacemaker Women with a positive pregnancy test or women who are lactating

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [11C]MK-3168 PET Scan<br> | Drug: [11C]MK-3168<br>* One PET scan involving administration of PET ligand [11C]MK-3168<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total distribution of [11C]MK-3168 in the brain | FAAH availability will be approximated using the FAAH positron emission tomography (PET) tracer [11C]MK-3168 total distribution | PET scan day |
Biomarkers and Preeclampsia Outcomes

Study Overview
=================
Brief Summary
-----------------
Prospective, observational, monocentric, non-interventional study.

Detailed Description
-----------------
In practice, patients with preeclampsia are referred to the hospital for medical management only clinical signs & symptoms and standard biological tests are available for patient individualized care. Hence, a new diagnostic tool to distinguish and stratify the different patients referred is in need of proper triage. REPORTS study aims to determine the diagnostic utility of 2 preeclampsia biomarkers (sFlt-1/PlGF ratio) in clinical decision making in preeclamptic women. Data are collected by DACIMA Clinical Suite, according to FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation)

Official Title
-----------------
Ratio of Angiogenesis-related Biomarkers (sFlt-1/PlGF) in the Prediction Of mateRnal & feTal outcomeS

Conditions
-----------------
Preeclampsia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected or confirmed preeclampsia Singleton pregnancy Between 26 weeks of gestation and 37 weeks of gestation & 6 days Exclusion Criteria: Multiple pregnancies

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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 |
| --- | --- | --- |
| Biomarkers ratio | sFlt-1/PlGF ratio | Every day from date of inclusion until date of delivery or up to 21 days whichever came first, in women with severe preeclampsia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers ratio | sFlt-1/PlGF ratio | Every two day from date of inclusion until date of delivery or up to 21 days whichever came first, in women with moderate preeclampsia | 
| Biomarkers ratio | sFlt-1/PlGF ratio | Weekly from date of inclusion until date of delivery or up to 3 weeks whichever came first, in women with mild preeclampsia | 
| Maternal outcome | Incidence of retroplacental hematoma, or HELLP syndrome (Hemolysis, Elevated liver enzyme levels, and Low Platelet levels), or Renal failure. | From date of inclusion until the date of first documented event, assessed up to 24 weeks | 
| Fetal outcome | Incidence of a composite fetal outcome (in utero fetal death or, Intrauterine growth restriction, or APGAR < 7, or Prematurity) | From date of inclusion until the date of first documented event, assessed up to 24 weeks | 
| Fetal outcome | Rate of in utero fetal death or, Intrauterine growth restriction, or APGAR < 7, or Prematurity | Date of delivery |
A FRENCH SURVEY OF THE DIAGNOSTIC AND THERAPEUTIC MANAGEMENT OF ELDERLY PEOPLE WITH HISTOLOGICALLY/CYTOLOGICALLY CONFIRMED LUNG CANCER.

Study Overview
=================
Brief Summary
-----------------
Management of lung cancer remains very controversial for elderly patients (pts) and they are often excluded from clinical trials. We present here a survey performed about the management of lung cancer pts aged 70 or more in France. All pts aged 70 or more with histo/cytologically proved lung cancer diagnosed between sept 02 and oct 03 in participating centers were recorded and their characteristics, the diagnostic procedures, therapeutic management and survival were analysed.

Official Title
-----------------
A FRENCH SURVEY OF THE DIAGNOSTIC AND THERAPEUTIC MANAGEMENT OF ELDERLY PEOPLE WITH HISTOLOGICALLY/CYTOLOGICALLY CONFIRMED LUNG CANCER.

Conditions
-----------------
ELDERLY PEOPLE, Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Procedure: diagnostic and therapeutic management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histo/cytologically proved lung cancer Exclusion Criteria: -

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: diagnostic and therapeutic management|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Work and Iron Status Evaluation

Study Overview
=================
Brief Summary
-----------------
This project seeks to understand how changes in the health of an individual affects the economic and social prosperity of the individual, family and community. The study involves providing iron supplements to a sample of participants in Central Java Indonesia and following those respondents for three years. They are compared with a control group who do not receive the supplement.

Detailed Description
-----------------
The goal of the study is to pin down the causal effect of improvements in health on the economic and social prosperity of individuals and their families. Particular attention will be paid to the dynamics underlying the effect of health on labor outcomes; older adults are more likely to experience transitions in health and economic status and so will be emphasized. Beginning in 2002, about 4,000 households will be interviewed every four months for about 3 years. The first two waves of the survey will serve as baselines. After the second wave, households will be randomly assigned to one of two groups. Iron supplements will be provided to all members of households assigned to one of those groups. Household members in the 2nd group will receive an identical-looking placebo. Participants will take the supplements (or placebo) on a weekly basis for a year. The study will measure the effect of supplementation on the well-being of individuals and their families. Data will be collected at the individual, household and community level. Individual level data will cover time allocation including work and participation in community activities, earnings, self-reported and physical health and cognition. All adult household members will be interviewed; questions about children will be answered by a caretaker. Data on wealth and consumption will be collected at the household level. Community resources, services and infrastructure information will be gathered along with detailed price data.

Official Title
-----------------
Work and Iron Status Evaluation (WISE)

Conditions
-----------------
Aging

Intervention / Treatment
-----------------
* Drug: Iron Supplement, 120mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Resident in village in study area in Purworejo District, Central Java, Indonesia Exclusion Criteria: None
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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Iron Supplement, 120mg|nan|

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
-----------------
Socioeconomic Factors, Dietary Supplementation
Clinical Trial Assessing 5-HT3 Receptor Antagonist (Ramosetron) for the Treatment of Anterior Resection Syndrome

Study Overview
=================
Brief Summary
-----------------
Poor functional outcomes has been reported inevitably, and up to 90% of the patients have experienced bowel habit changes after sphincter-saving surgery for rectal cancer. But, currently there has been no specific treatment for ARS and symptom based empirical management is tried Recently, 5-HT3 receptor antagonists can be used for treatment of IBS-D, and has been revealed to be slowing the bowel movement and improving stool consistency and urgency. We performed the clinical trial with using ramosetron (Irribow®) for the treatment of ARS

Conditions
-----------------
Anterior Resection Syndrome

Intervention / Treatment
-----------------
* Drug: Ramosetron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients who undergo sphincter saving surgery for rectal cancer Exclusion Criteria: recurred rectal cancer rectal cancer with distant metastasis permanent stoma formation postoperative concurrent chemoradiotherapy uncontrolled medical disease inflammatory bowel disease uncontrolled constipation preoperative incontinence (LARS score, more than 20) allergic to intervention drug

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>ramosetron treatment for 4 weeks from 1mo after anterior resection for rectal cancer | Drug: Ramosetron<br> <br> |
| No Intervention: Control<br>No treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| low anterior resection syndrome score | questionnaire with comparison of frequency or urgency | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life score | EORTC QLQ C30 (Korean version, validated) | 4 weeks |
Clinical Survey of Oticon Medical Ponto BHX Implant

Study Overview
=================
Brief Summary
-----------------
Investigation of stability of the BHX implant in adult patients indicated and counselled for a bone anchored hearing aid system. Patients are followed according to clinical practice for a total of 12 months in the study. Stability of the implant is evaluated by implant stability quotient.

Official Title
-----------------
Clinical Survey of Oticon Medical Ponto BHX Implant

Conditions
-----------------
Hearing Impaired (Partially), Hearing Impairment, Conductive, Deafness Unilateral

Intervention / Treatment
-----------------
* Device: BHX implant (Bone anchored hearing system)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients eligible for treatment with a bone anchored hearing aid 18 years or older Exclusion Criteria: Inability to participate in follow-up Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: BHX implant<br>All patients implanted with BHX implant | Device: BHX implant (Bone anchored hearing system)<br>* Bone anchored hearing system for hearing rehabilitation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant stability quotient (ISQ) at surgery | Initial implant stability measured directly after surgery | At surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical torque setting measured in Ncm | The surgical torque setting used to install the implant | At surgery | 
| Possibility to fit the sound processor, yes/no | Fitting of the sound processor at 5-12 days post-surgery | 5-12 days post surgery | 
| Implant stability quotient (ISQ) after 12 months of follow up | Long term stability development | 12 months post surgery | 
| Implant survivability measured as percentage successful implants after 12 months | Implant survivability | 12 months post surgery |
Assessment of the Evolutions of Transcutaneous CO2 With the Modification of Blood Flow During On-pump Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
There are no available criteria for determining the optimal flow rate and mean arterial pressure level in patients under cardiopulmonary bypass (CPB). Transcutaneous carbon dioxide tension (PtCO2) has been proposed for microcirculation monitoring and it could be useful for guiding hemodynamic optimization under CPB. The goal of this exploratory study was to determine the factors that influence PtCO2 variations during CPB. DESIGN: Cutaneous ear lobe CO2 tension was monitored along with hemodynamic parameters every 10 minutes during CPB, until aortic unclamping. SETTING: French university teaching hospital PARTICIPANTS: Patients scheduled for cardiac surgery requiring CPB were prospectively included.

Official Title
-----------------
Assessment of the Evolutions of Transcutaneous CO2 With the Modification of Blood Flow During On-pump Cardiac Surgery

Conditions
-----------------
PtCO2, Extracorporeal Ventilation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for cardiac surgery under cardiac arrest and cardiopulmonary bypass were prospectively included in the present observational study conducted at a French teaching hospital. Exclusion Criteria: The exclusion criteria were: age <18, pregnancy, septic or emergency surgery.

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 |
| --- | --- | --- |
| PtCO2 |  | intraoperative value |