linjc16/ctgov huggingface dataset:
Bronchiectasis and NTM Research Registry

Study Overview
=================
Brief Summary
-----------------
The Bronchiectasis Research Registry is a consolidated database of non-cystic fibrosis (non-CF) Bronchiectasis and Nontuberculosis Mycobacteria (NTM) patients from multiple clinical institutions.

Detailed Description
-----------------
The Bronchiectasis Research Registry is a consolidated database of non-cystic fibrosis (non-CF) Bronchiectasis and Nontuberculosis Mycobacteria (NTM) patients from multiple clinical institutions. The goal of the Bronchiectasis Research Registry is to support collaborative research and assist in the planning of multi-center clinical trials for the treatment of NTM and non-CF Bronchiectasis, a progressive, non-curable disease of the lungs, which afflicts thousands of patients. The Registry will also be used to provide better insight into the study of the different types of Bronchiectasis, as well as the pathophysiology of the disorder. In 2012, in collaboration with NTM Info and Research, Inc (NTMir) and the consortium members, the COPD Foundation expanded the Bronchiectasis Research Registry to enroll patients with non tuberculous mycobacteria (NTM) only. Prior to this time, the registry included individuals with Bronchiectasis, with or without NTM.

Official Title
-----------------
Bronchiectasis and NTM Research Registry

Conditions
-----------------
Non-CF Bronchiectasis, Nontuberculosis Mycobacteria (NTM)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over the age of 18 non-CF Bronchiectasis Nontuberculosis Mycobacteria (NTM) Exclusion Criteria: Under the age of 18 CF Bronchiectasis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 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 |
| --- | --- |
| Non-CF Bronchiectasis Patients with or without NTM<br>Patients over the age of 18 with non-CF Bronchiectasis with or without Nontuberculosis Mycobacteria (NTM). | |
| Nontuberculosis Mycobacteria (NTM)<br>Patients over the age of 18 with Nontuberculosis Mycobacteria (NTM) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Recruitment and Data analysis | The COPD Foundation expects to assist at least 4 researchers (with patient recruitment and/or data analysis) annually. | December 2050 |
Living-Related Donor Bone Marrow Immunoregulation in Kidney Transplants

Study Overview
=================
Brief Summary
-----------------
Diabetes and end-stage kidney, liver and heart disease are prominent health issues among veteran patients. Successful solid organ transplantation in the absence of chronic immunosuppressive therapy (specific acquired immunological tolerance) is a desirable therapeutic option. This project extends recent observations supporting the use of concommitant donor bone marrow cell infusion as a means of modulating the immune response in kidney transplantation, thereby allowing a substantial decrease or withdrawal of potentially toxic immunosuppressive drugs.

Official Title
-----------------
Living-Related Donor Bone Marrow Immunoregulation in Kidney Transplants

Conditions
-----------------
Kidney Disease

Intervention / Treatment
-----------------
* Procedure: donor bone marrow infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Living related donor kidney transplant recipients and the living related donors.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: donor bone marrow infusion|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
-----------------
kidney transplantation, immunosuppression, bone marrow
Use of AliveCor ECG Monitoring to Replicate ECG Lead Recording

Study Overview
=================
Brief Summary
-----------------
The researchers are trying to determine whether the Alivecor device can simulate other electrocardiogram (ECG) leads to record electrical activity.

Official Title
-----------------
Use of AliveCor ECG Monitoring to Replicate ECG Lead Recording

Conditions
-----------------
Arrhythmia

Intervention / Treatment
-----------------
* Device: AliveCor Heart Monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals greater than 18 years old getting an ECG Exclusion Criteria: Patients unwilling or unable to provide informed consent

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subject getting an ECG<br>Subjects getting an ECG will have AliveCore tracings obtained in 3 configurations; between right hand and left hand, between left hand and left lower leg (thigh, calf, and foot) and between right hand and left lower leg (thigh, calf, and foot).These configurations will be obtained with the participant lying in bed and in a sitting position. | Device: AliveCor Heart Monitor<br>* Records single-channel ECG rhythms<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrocardiogram (ECG) QT Interval | The QT interval represents the time of ventricular activity including both depolarization and repolarization. It is measured from the beginning of the QRS complex to the end of the T wave. Normally, the QT interval is 0.36 to 0.44 seconds | 1 day |
Serum Sample Collection to Determine Analytical Performance Characteristics of the ADVIA Centaur PAPPA and BhCG Assays

Study Overview
=================
Brief Summary
-----------------
Blood samples collected will be shipped to the sponsor's laboratory to establish analytical performance characteristics of the ADVIA Centaur® Pregnancy Associated Plasma Protein A (PAPP-A) and ADVIA Centaur® Free Beta Human Chorionic Gonadotropin (Free βhCG) assays.

Detailed Description
-----------------
Blood samples are to be collected from pregnant women attending their scheduled 1st Trimester scan; the samples are to be collected immediately after the subject's routine blood sample at the clinic visit. No extra venepuncture will be required. Blood samples collected will be shipped to the sponsor's laboratory to establish analytical performance characteristics of the ADVIA Centaur® Pregnancy Associated Plasma Protein A (PAPP-A) and ADVIA Centaur® Free Beta Human Chorionic Gonadotropin (Free βhCG) assays.

Official Title
-----------------
Serum Sample Collection to Determine Analytical Performance Characteristics of the ADVIA CENTAUR® PREGNANCY ASSOCIATED PLASMA PROTEIN A and ADVIA Centaur® Free Beta Human Chorionic Gonadotropin ASSAYS

Conditions
-----------------
Trisomy 21 in Fetus, Trisomy 18 in Fetus, Trisomy 13 in Fetus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A subject is considered eligible for participation in the trial if all of the following inclusion criteria are satisfied prior to enrolment: Subject is ≥ 18 years of age Subject is informed and has been given ample time and opportunity to think about her participation and has given her written informed consent. Women with a structurally normal viable pregnancy with a fetal crown rump length of 45-84 mm Exclusion Criteria: A subject is not eligible for participation in the trial if any of the following exclusion criteria are met prior to enrolment: Subject is unable to give consent Subject has already participated in the study

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sample handling | Percentage change in PAPPA and BhCG levels from baseline sample type to sample type under test. | 3 months |
Hyponatraemia and Mortality in Schizophrenic and Bipolar Patients: Protocol for a Bayesian Causal Inference Study

Study Overview
=================
Brief Summary
-----------------
This study seeks to investigate if hyponatraemia be a direct contributor to death in schizophrenic and bipolar patients, and gauge the potential role of somatic comorbidity and psychotropic polypharmacy, with emphasis on antipsychotics and antidepressants.

Official Title
-----------------
Is Hyponatraemia a Risk Factor for Mortality in Schizophrenic and Bipolar Patients? Protocol for a Bayesian Causal Inference Study

Conditions
-----------------
Hyponatremia, SIADH

Intervention / Treatment
-----------------
* Other: Plasma sodium level (continuous variables)


Participation Criteria
=================
Eligibility Criteria
-----------------
Source population: Danish residents At least one International Classification of Diseases version 10 (ICD-10) F2 or F31 diagnosis from a hospital in Region Zealand and the Capital Region (Denmark) No exclusion criteria.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases<br> | Other: Plasma sodium level (continuous variables)<br>* Observational study, so the exposures of interest (5-year mean and minimum plasma sodium) are not administered to the patients. Ultimately, our interest is in hyponatraemia.<br>|
| Controls<br>Matched (5 controls per case) by date of birth +/- 180 days. | Other: Plasma sodium level (continuous variables)<br>* Observational study, so the exposures of interest (5-year mean and minimum plasma sodium) are not administered to the patients. Ultimately, our interest is in hyponatraemia.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | All-cause mortality | 1 January 2011 through 1 July 2016 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Causality, Bayesian analysis, Antipsychotics, Psychotropics, Polypharmacy
Carbetocin Versus Oxytocin and Hemodynamic Effects

Study Overview
=================
Brief Summary
-----------------
A randomized double-blind trial of oxytocin 5 u, carbetocin 100 µg and placebo with hemodynamic response as a primary outcome measure.

Detailed Description
-----------------
Healthy pregnant women sheduled for elective cesarean section. Invasive hemodynmaic monitoring with LiDCO Plus.

Official Title
-----------------
Hemodynamic Effects of Carbetocin 100 µg, Oxytocin 5 U or Placebo After Cesarean Delivery Under Spinal Anesthesia in Healthy Pregnant Women.

Conditions
-----------------
Effects of; Anesthesia, in Pregnancy

Intervention / Treatment
-----------------
* Drug: carbetocin 100 µg
* Drug: oxytocin 5 u
* Drug: placebo (NaCl)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy pregnant women for planned cesarean section Exclusion Criteria: Bleeding disorders Placenta disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: carbetocin 100 µg<br>Carbetocin injection, 100µg, single injection | Drug: carbetocin 100 µg<br>* Hemodynamic effect of<br>* Other names: Pabal, injection;|
| Active Comparator: oxytocin 5 u<br>Oxytocin 5U, injection, single injection | Drug: oxytocin 5 u<br>* Hemodynamic effect of<br>* Other names: Syntocinon, injection;|
| Placebo Comparator: placebo (NaCl)<br>Saline single injection | Drug: placebo (NaCl)<br>* Hemodynamic effect of<br>* Other names: Saline, injection;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Output | The relative change in CO from baseline at the time of delivery up to 2.5 minutes post delivery. | 2.5 minutes | 
| Arterial Blood Pressure | The mean change in SAP compared with baseline at the time of delivery up to 2.5 minutes post delivery. | 2.5 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding | The calculated estimated blood loss from delivery until 2 h after intervention | 120 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cesarean delivery, blood pressure, cardiac output
Combined Treatment of RFA and Sorafenib on Recurrent HCC

Study Overview
=================
Brief Summary
-----------------
RFA is a routaine treatment of recurrent HCC. Recently Sorafenib was reported to be a promising drug to treat late stage HCC. But few studies were related with its effectiveness on recurrent HCC. So the investigators hypothesized that combined RFA and Sorafenib might reduce the frequency of recurrence and improve the overall survival and disease free survial.

Official Title
-----------------
Radiofrequency Ablation Plus Sorafenib Administration in Early Recurrent Hepatocellular Carcinoma: a Prospective Multicenter Cohort Trial (Repeat) Tumors for BCLC B Stage HCC Undergone Curative Hepatectomy

Conditions
-----------------
HCC, Radiofrequency Ablation, Sorafenib

Intervention / Treatment
-----------------
* Other: RFA + Sorafenib
* Other: RFA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: recurrent HCC after curative resection without gender restriction age between 18 to 75 years The liver function showed no worse than Child-Pugh B tumor nodes were less than 5cm and no more than 3 nodules Exclusion Criteria: Pregnancy patients With extrahepatic tumor or lymphnode metastasis Tumor invasion or thrombosis in portal vein,hepatic vein or inferior vena cava

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RFA+Sorafenib<br>to treat recurrent HCC both with RFA and Sorafenib | Other: RFA + Sorafenib<br>* combined RFA and Sorafenib to treat recurrent HCC<br>|
| Active Comparator: RFA group<br>To treat recurrent HCC with RFA | Other: RFA<br>* treat Recurrent HCC with RFA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time interval between new lessions emerging after the first HCC recurrence |  | 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year overrall survival |  | 3 year |
A Shared Decision Making Training for Inpatients With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
Patients suffering from schizophrenia who attend the communication skills program engage more deeply in therapeutic reasoning and treatment decisions. This results in stronger preferences to participate, greater perceived involvement and better long term adherence compared to patients who do not attend the training.

Official Title
-----------------
Shared Decision Making: Ein Kommunikationstraining für Patienten Mit Schizophrenie

Conditions
-----------------
Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
-----------------
* Behavioral: patient training in shared decision making
* Behavioral: cognitive training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female inpatients with a diagnosis of schizophrenia/schizoaffective disorder according to ICD 10 between 18 and 60 years of age are eligible for the study informed consent inpatients Exclusion Criteria: poor German language skills

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: communication skills training<br>group training in shared decision making. | Behavioral: patient training in shared decision making<br> <br> |
| Active Comparator: cognitive training<br>standard group training of cognitive skills (Konzentrationstraining) | Behavioral: cognitive training<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decision Self Efficacy |  | post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to medication |  | 6 months post intervention | 
| Participation preferences |  | post intervention | 
| Treatment satisfaction |  | post intervention |
Professional Quality of Life in German Psychiatrists

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess professional quality of life in German psychiatrists working with patients with mental disorders.

Detailed Description
-----------------
The purpose of this study is to assess professional quality of life, which includes compassion satisfaction, burnout and secondary traumatization in psychiatrists, working with patients with mental disorders, in Germany.

Official Title
-----------------
Professional Quality of Life in German Psychiatrists Working With Patients With Mental Disorders

Conditions
-----------------
Mental Disorder, Burnout, Caregiver, Burnout, Professional

Intervention / Treatment
-----------------
* Diagnostic Test: Online questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Psychiatrits (Physician with specialization in psychiatry or currently in specialization for psychiatry) Currently working with patients with mental disorders At least 18 years old Sufficient German skills for answering the questionnaire Exclusion Criteria: None

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 |
| --- | --- |
| Psychiatrists in Germany<br>Psychiatrists in Germany currently working with patients with mental disorders | Diagnostic Test: Online questionnaire<br>* Clinical psychologists in Germany currently working with patients with mental disorders<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compassion Satisfaction | Professional Quality of Life: Compassion Satisfaction and Fatigue Version 5 (ProQOL) - German Version - Subscale Compassion Satisfaction (Minimum: 10 - Maximum: 50 - Higher scores mean a higher compassion satisfaction. | 1 day | 
| Burnout | Professional Quality of Life: Compassion Satisfaction and Fatigue Version 5 (ProQOL) - German Version - Subscale Burnout (Minimum: 10 - Maximum: 50 - Higher scores mean a higher level of burnout. | 1 day | 
| Traumatization | Professional Quality of Life: Compassion Satisfaction and Fatigue Version 5 (ProQOL) - German Version - Subscale Secondary Traumatization (Minimum: 10 - Maximum: 50 - Higher scores mean a higher level of secondary traumatization. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Professional quality of life, Compassion satisfaction, Burnout, Psychiatrists, Mental disorders, Mental health
Novel MRI Techniques in the Evaluation of Pulmonary Vascular Disease

Study Overview
=================
Brief Summary
-----------------
The diagnosis of a patient with pulmonary hypertension (PH) requires many investigations. At present cardiac catheterisation is the cornerstone investigation in these patients where it is used to establish disease severity and estimate prognosis. It is an invasive procedure which is expensive and not without risk to the patient. Despite the multitude of tests performed, identifying those patients with PH who have a poor diagnosis can be difficult. The aim of this study is to improve the assessment of patients with PH using novel magnetic resonance techniques.

Official Title
-----------------
Novel MRI Techniques in the Evaluation of Pulmonary Vascular Disease

Conditions
-----------------
Pulmonary Hypertension

Intervention / Treatment
-----------------
* Other: 3-Helium gas


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All cases referred to the clinic for assessment for possible pulmonary hypertension. Exclusion Criteria: patients with a cardiac pacemaker or retained temporary pacing wire patients with aneurysm clip non MRI compatible heart valve prosthesis intra orbital metalic foreign body pregnancy metal prosthesis/spinal rods retained shrapnel cochlear implants/bladder stimulator

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3-Helium inhalation gas<br>This is a pilot study. The aim is to recruit 20 patients who will all receive the product under investigation. | Other: 3-Helium gas<br>* 3-Helium gas for MRI contrast<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulmonary artery diameter (mm) | Three-dimensional MRI imaging will be used to acquire cardiac dimensions and anatomical ventilation distribution as well as regional partial pressures of oxygen in the lungs. | up to 3 months |