linjc16/ctgov huggingface dataset:
Brief Interventions for Drop-out Re-engagement

Study Overview
=================
Brief Summary
-----------------
We will evaluate a series of interventions intended to help individuals who drop out of substance abuse treatment re-engage in order to improve treatment outcome.

Detailed Description
-----------------
We propose a 5-year Stage I behavioral therapy development study to: 1) prospectively evaluate risk factors for premature drop-out from outpatient treatment; 2) develop and test a manual of single session phone-and office-based interventions to re-engage these individual in treatment.

Official Title
-----------------
Adaptive Brief Interventions for Drop-out Re-engagement

Conditions
-----------------
Substance Abuse

Intervention / Treatment
-----------------
* Behavioral: brief (behavioral therapy)
* Behavioral: Drop out re-engagement motivational intervention
* Behavioral: standard care follow up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: admission to outpatient treatment Exclusion Criteria: need for hospitalization

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard care follow up<br>Standard care counselor follow up care phone calls or letters. | Behavioral: standard care follow up<br>* routine counselor phone calls and letters<br>|
| Experimental: Drop out reengagement motivational intervention<br>Single session office based or phone based motivational counseling session designed to promote participant re-engagement in standard treatment. | Behavioral: brief (behavioral therapy)<br>* up t 3 sessions of phone or office based counseling sessions to promote re-engagement in treatment.<br>Behavioral: Drop out re-engagement motivational intervention<br>* Up to 3 phone or office based counseling sessions to promote reengagement in treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| retention into outpatient treatment |  | 4, 8, 12, 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| substance abuse |  | 4, 8,12,and 24 weeks | 
| psychiatric symptoms |  | 4, 8, 12, and 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
behavior therapy, counseling, drug abuse therapy, outpatient care, therapy compliance, clinical trial phase I, coping, outcomes research, satisfaction, social psychology, patient oriented research
Endometrial Sampling (Pipelle)in IVF Patients

Study Overview
=================
Brief Summary
-----------------
A prospective cross-over randomized study aimed to test the hypothesis that local injury of the endometrium increases the implantation rate in the successive cycle. Seventy IVF patients will be randomly selected to undergo either endometrial biopsies or minimal cervical scratch on days 8-10 and 21-23 of their cycle, preceding the IVF treatment. If not pregnant, the women will continue for another IVF cycle, preceded by endometrial or cervical scratch complimentary to their procedure in the first cycle. The main major outcomes will include pregnancy rate, implantation rate, endometrial thickness, abortion rate, live births and embryo quality.

Official Title
-----------------
Endometrial Sampling (Pipelle)in IVF Patients

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

Intervention / Treatment
-----------------
* Procedure: Pipelle (Endometrial Sampling)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women undergoing IVF treatment Repeated Implantation failure Exclusion Criteria: PID or suspected PID Undiagnosed Irregular Bleeding

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Pipelle (Endometrial Sampling)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Haploidentical Transplantation With CD3/CD19 Depleted Grafts in Patients With Hematologic Malignancies

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the feasibility and Toxicity of allogeneic haploidentical hematopoietic cell transplantation with CD3/CD19 depleted stem cells and a dose reduced conditioning.

Detailed Description
-----------------
Transplantation of a CD3/CD19 depleted stem cell grafts after dose reduced conditioning for the treatment of treatment refractory or relapsed hematologic malignancies after preceding allogeneic or autologous hematopoietic cell transplantation.

Official Title
-----------------
Multicenter Phase I/II Study of Haploidentical Hematopoietic Cell Transplantation With CD3/CD19 Depleted Grafts in Patients With Treatment Refractory Hematologic Malignancies

Conditions
-----------------
Hematologic Malignancies

Intervention / Treatment
-----------------
* Drug: Fludarabine
* Drug: Thiotepa
* Drug: Melphalan
* Drug: OKT-3
* Procedure: CD3/CD19 depletion on CliniMACS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age <60, >18 years Karnofsky >60% High risk hematologic malignancy or relapse after preceding auto/allo HCT in patients with: ALL AML PNH MDS (RAEB-t/secondary AML) NHL ALL HD CML MM No HLA-identical MRD or URD if not preceding allo-HCT Use haploidentical donor with KIR-Mismatch if choice Exclusion Criteria: < 3 months after preceding HCT Active cerebral seizures > 30% blasts in BM if ALL/AML/CML-BC Completely chemo-refractory Preceding myocardial infarction Ejection fraction <30 % echocardiography Creatinine clearance <50 ml/min Respiratory insufficiency on supplemental O2 or DLCO < 30% Allergy against murine antibodies HIV infection Pregnancy Unable for informed consent

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fludarabine|nan|
|Drug: Thiotepa|nan|
|Drug: Melphalan|nan|
|Drug: OKT-3|nan|
|Procedure: CD3/CD19 depletion on CliniMACS|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Engraftment |  |  | 
| Toxicity |  |  | 
| Mortality and Morbidity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infections |  |  | 
| GVHD |  |  | 
| Immune reconstitution |  |  | 
| Disease response |  |  | 
| Long term toxicity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
haploidentical transplantation, immunomagnetic cell sorting, allogeneic hematopoietic cell transplantation, dose reduced conditioning
Serum Procalcitonin Study in the Management of Ventilated Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test a new method for diagnosing and monitoring Ventilator-Associated Pneumonia, which is a major killer among ICU patients. The method requires analysis of a small amount of the patient's blood for concentration of a hormone called Procalcitonin.

Detailed Description
-----------------
Ventilator-associated pneumonia is a leading cause of mortality in critically ill patients. The purpose of this study is to evaluate the relationship between the onset/progress/resolution of pneumonia and the levels of Procalcitonin, a prohormone whose concentrations fluctuate in response to bacterial infection.

Official Title
-----------------
Clinical Utility of Serum Procalcitonin in the Management of Ventilator-Associated Pneumonia

Conditions
-----------------
Ventilator Associated Pneumonia

Intervention / Treatment
-----------------
* Device: Procalcitonin Level


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are willing to give or who's proxy is willing to consent to be a study subject Are at least 18 years of age; Who are mechanically ventilated surgical intensive care unit patients. Exclusion Criteria: Participation in any investigational device or drug trial within 30 days prior to enrollment.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Procalcitonin Level|Procalcitonin concentrations will be determined every day and will be compared with the clinical diagnosis based upon standard clinical practice. All subjects enrolled will be followed until the patient is either extubated or discharged from the SICU.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Procalcitonin concentration with the LungGuardian-derived Pneumonia Score in mechanically ventilated surgical intensive care unit patients. Using the data collected a positive and negative predictive value will be calculated. |  | Once daily | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| antibiotic status (appropriateness, effectiveness, discontinuation criteria) |  | Once daily | 
| intubation date |  | Once daily | 
| microbiology data |  | Once daily | 
| PCT levels |  | Once daily | 
| pneumonia-related symptoms (including tracheal secretion character, body temperature, oxygenation, and WBC counts) |  | Once daily | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ventilator associated Pneumonia, mechanically ventilated, procalcitonin, pneumonia scores
PROSPective Evaluation of Outcome After CatheTer Ablation in Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
Atrial fibrillation ablation is the most common intervention performed worldwide. Up to 20 to 45% of patients show recurrence of AF within 12 month after catheter ablation, however its determinant are incompletely understood. The aim of the PROSPECT-AF study is to assess the predictors of AF recurrence within the 3 years following ablation using clinical variables and innovative biomarkers in a prospective cohort of 750 patients undergoing atrial fibrillation catheter ablation. The secondary aims are to assess the incidence of major adverse cardiovascular outcomes (MACE) and the incidence of major bleeding within the 3 years Wolfing catheter ablation.

Official Title
-----------------
PROSPective Evaluation of Outcome After CatheTer Ablation in Atrial Fibrillation : LONGITUDINAL STUDY OF PATIENTS UNDERGOING RADIOFREQUENCY ABLATION OF ATRIAL FIBRILLATION.

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Procedure: atrial fibrillation catheter ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient undergoing atrial fibrillation catheter ablation Able to give their consent Exclusion Criteria: Childs Patient under guardianship Patients unable to give their consent Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Patients undergoing atrial fibrillation catheter ablation<br>Patients undergoing scheduled atrial fibrillation catheter ablation. | Procedure: atrial fibrillation catheter ablation<br>* The ablation is performed under local anesthesia or general anesthesia. A transseptal puncture will be performed to access the left atrium. Pulmonary vein isolation will be performed as a first step. Additional lesions will be made at the discretion of the operators. Patients will receive anticoagulation for at least 3 months after the ablation. Treatment thereafter will be extended at the discretion of the treating physician.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of atrial fibrillation recurrence. |  | At 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of major adverse cardiovascular events (MACE) including hospitalization for acute heart failure, cardiovascular death, stroke, myocardial infarction |  | At 3 years | 
| Incidence of major bleeding (defined by BARC≥3 bleeding) |  | At 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial fibrillation, Catheter ablation, Arrhythmia, Biomarkers
Morning Bright Light to Improve Sleep Quality in Veterans

Study Overview
=================
Brief Summary
-----------------
One of the principal complicating factors associated with traumatic brain injury (TBI) is sleep-wake disturbances (e.g., insomnia, excessive daytime sleepiness, and circadian rhythm sleep disorders). Morning bright light therapy (MBLT) has been shown to improve sleep quality in a variety of conditions, but little has been done investigating the utility of MBLT in improving sleep in Veterans with TBI. This proposal aims to determine the effect of MBLT on sleep quality in Veterans with TBI. Veterans with and without TBI will be recruited from the VA Portland Health Care System. Baseline questionnaires and 7 days of actigraphy will be collected prior to engaging in 60 minutes of MBLT daily for 4 weeks, during which actigraphy will also be collected continuously. Post-MBLT questionnaire data will be collected, and follow-up questionnaire data will be collected at 3 months post-MBLT.

Official Title
-----------------
Morning Bright Light to Improve Sleep Quality in Veterans

Conditions
-----------------
Brain Injuries, Traumatic, Post-traumatic Stress Disorder

Intervention / Treatment
-----------------
* Other: Morning Bright Light Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Veterans Exclusion Criteria: History of bipolar disorder History of macular degeneration Non-English speaking Decisionally impaired Currently using a light box

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Morning Bright Light Therapy<br>Subjects who engage in morning bight light therapy | Other: Morning Bright Light Therapy<br>* 60 minutes of bright light therapy (10,000 lux) received within 90 minutes of waking<br>|
| No Intervention: Control<br>Subjects who do not engage in morning bright light therapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Insomnia Severity Index (ISI) | Measures self-reported insomnia severity; total score range = 0-28 (higher total score = worse insomnia) | Baseline; after 4 weeks of intervention; and 2 months after the end of intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep, Bright Light
Follow up Glucose Levels Among Infants of Diabetic Mothers

Study Overview
=================
Brief Summary
-----------------
Infants to diabetic mothers (IDM) are at risk for developing hypoglycemia after birth. Glucose level follow ups are recommended to each IDM. However, there are no recommendations as to how long this follow up should be performed for, nor are there safe glucose levels that allow stopping glucose monitoring. The aim of the study is to retrospectively follow up glucose levels among IDMs in order to find risk factors for developing hypoglycemia and determine time and glucose levels that would permit monitoring cessation.

Detailed Description
-----------------
A retrospective study of 250-300 IDMs, born in a single large medical center. Data will be collected as follows: Gestational age, birth weight, sex, delivery mode, type of maternal diabetes, other maternal diseases, feeding mode. Glucose levels as were recorded according to newborn protocol (1,2,4,6 hours after delivery, and then every 8 hours for total of 48 hours). Data of hypoglycemia treatment, if given, will be collected. Later we will statistically try to determine the risk factors for developing hypoglycemia and the safe time and glucose levels to stop monitoring.

Conditions
-----------------
Newborn, Full Term, Diabetic Mother

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Full-term infants, diabetic mothers, Singleton Exclusion Criteria: Preterm infants, multiple pregnancy, congenital malformations, clinically ill at birth.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 1 Day

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
-----------------
gestational diabetes, newborn, hypoglycemia
EVALECGcardio Study

Study Overview
=================
Brief Summary
-----------------
ECGs are routinely performed in cardiology. Recently handheld ECGs have shown promise in screening for heart rhythm disorders. These are quick to perform and do not require the preparation that is needed for 12 lead ECGs. We wanted to test whether a novel handheld ECG recorder, Kardia 6L, which has the potential to record a 6 lead ECG is able to screen for ECG abnormalities, thereby obviating the need for a full 12 lead ECG. This may allow for earlier diagnosis and treatment.

Detailed Description
-----------------
The aim of analysis is to determine if the handheld 6 lead ECG can be used as a simple screener to identify patients who do not need a 12 lead ECG.

Official Title
-----------------
An Evaluation of the Safety and Clinical Utility of Handheld ECG Technology in Cardiology

Conditions
-----------------
Cardiac Arrhythmia

Intervention / Treatment
-----------------
* Device: 6 Lead ECG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anyone attending cardiology outpatients or the ward who has had a recent ECG (within 6 hours) Exclusion Criteria: Patients who do not consent to the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients attending cardiac outpatient clinic<br> | Device: 6 Lead ECG<br>* Patients will be assessed with the Kardiamobile device.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between the 6 lead and the 12 lead Electrocardiogram | Sensitivity and specificity of handheld 6Lead compared to 12lead for the measurement of the stages of heart rhythms. | 2 minutes |
Effect of Actonel on Periodontal Health of Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Women who use Actonel (risedronate) for osteopenia will show beneficial periodontal effects.

Detailed Description
-----------------
Women who use Actonel for osteopenia will show beneficial attachment loss, alveolar bone height and morphology as compared to those who do not when oral hygiene is corrected for.

Official Title
-----------------
Effect of Actonel on Periodontal Health of Postmenopausal Women

Conditions
-----------------
Periodontal Disease

Intervention / Treatment
-----------------
* Drug: Risedronate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Osteopenia Postmenopausal Exclusion Criteria: Male Diabetes

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E, I<br> | Drug: Risedronate<br>* Weekly Risedronate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periodontal alveolar bone changes |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periodontal attachment levels |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteopenia, periodontitis