linjc16/ctgov huggingface dataset:
Clinician Ability to Predict the Presence of Nosocomial Pneumonia Based on Bronchoscopic Findings

Study Overview
=================
Brief Summary
-----------------
This study aims to determine whether interpretations of bronchoscopic results enable physicians to successfully predict the presence of pneumonia in traumatically injured patients.

Detailed Description
-----------------
This study aims to determine whether interpretations of bronchoscopic results enable physicians to successfully predict the presence of pneumonia in traumatically injured patients. Bronchoscopies will be videotaped. The clinician doing the procedure will make prediction as to whether the patient, in fact, has pneumonia. In addition, at least one other physician will view the videotape and predict whether the patient has pneumonia. Once laboratory results are available, the physician predictions will be compared against the definitive laboratory determination

Official Title
-----------------
Clinician Ability to Predict the Presence of Nosocomial Pneumonia Based on Macroscopic Examination of Bronchoscopic Findings in Critically Ill Surgical Patients

Conditions
-----------------
Pneumonia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Critical Care staff and fellows of the Departments of Anesthesia and Surgery Exclusion Criteria: Refusal of consent

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients receiving bronchoscopy<br>Patients suspected of having pneumonia received bronchoscopy to examine the lungs and to capture alveolar lavage culture | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence or absence of hospital-acquired pneumonia | When pneumonia is suspected, patient with undergo bronchoscopy. BAL specimens will be submitted to laboratory testing. Laboratory results are the definitive indication of pneumonia, or lack thereof. | At first clinical suspicion of pneumonia. Average of hospital Day 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pneumonia
Effect of Epidural Dexamethasone on Labor Analgesia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to detect whether the addition of epidural dexamethasone will prolong labor analgesia.

Official Title
-----------------
Epidural Levobupivacaine Versus A Combination of Levobupivacaine and Dexamethasone in Parturients Receiving Epidural for Vaginal Delivery Analgesia: A Comparative, Dose Ranging and Safety Evaluation Study

Conditions
-----------------
Labor

Intervention / Treatment
-----------------
* Drug: Levobupivacaine
* Drug: Dexamethasone and levobupivacaine
* Drug: Levobupivacaine and Dexamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA physical status I, II normal vaginal delivery In early active phase of labor singleton cephalic presentation at term Exclusion Criteria: complicated pregnancies morbid obesity diagnosed fetal abnormalities contra-indications to regional anesthesia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group L<br>Epidural levobupivacaine 0.125% (Chirocaine) in normal saline in a total volume of 10 ml will be administered epidurally in active stage of labor | Drug: Levobupivacaine<br>* Levobupivacaine will be given epidurally and the duration of analgesia will be calculated<br>|
| Active Comparator: group LD4<br>Epidural levobupivacaine 0.125%(Chirocaine) in normal saline combined with dexamethasone 4 mg in a total volume 10 ml | Drug: Dexamethasone and levobupivacaine<br>* dexamethasone 4 mg epidurally with levobupivacaine and duration of analgesia is measured<br>|
| Active Comparator: group LD8<br>Epidural levobupivacaine 0.125%(Chirocaine) in normal saline combined with dexamethasone 8 mg in a total volume 10 ml | Drug: Levobupivacaine and Dexamethasone<br>* dexamethasone 8 mg epidurally with levobupivacaine and duration of analgesia is measured<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of epidural analgesia |  | an average of 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of onset of sensory block at level T10 | From the onset of active stage till the end of labor | an average of 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
epidural analgesia
Effective Postoperative Pain Treatment After Sternotomy. Comparison of the Erector Spinae Plane Block vs Conventional Opioid Treatment

Study Overview
=================
Brief Summary
-----------------
Comparison of effect between Erector Spinae plane block and conventional opioid treatment after cardiac surgery

Detailed Description
-----------------
Comparison of effect between Erector Spinae plane block and conventional opioid treatment after cardiac surgery. In group A will be erector spinae plane block provided in the thoracic part of the body, under ultrasound control. In the group B will be analgesia provided by Pethidine. Numerical pain score will be recorded every 2 hours, also usage of analgetics will be recorded in both groups.

Official Title
-----------------
VUSCH/PostOperativePainTreatment1

Conditions
-----------------
Pain Reliefe

Intervention / Treatment
-----------------
* Procedure: Satisfaction assessed by the VAS [followed by its scale information in the Description]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postoperative state after cardiac surgery, Serious pain NRS 8-10 Exclusion Criteria: disagreement

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ESPB<br>Erector spinae plane block group | Procedure: Satisfaction assessed by the VAS [followed by its scale information in the Description]<br>* Erector spinae plane block provided in thoracic part of spine, VAS scale 0-10<br>|
| Opioids<br>Opioid group | Procedure: Satisfaction assessed by the VAS [followed by its scale information in the Description]<br>* Erector spinae plane block provided in thoracic part of spine, VAS scale 0-10<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with pain treatment assessed by the numerical rating scale VAS | Pain assessed by VAS 0-10 score | 12 hours |
Parenting a Child With Autism Spectrum Disorder and Marital Status

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether the presence of a child with Autism Spectrum Disorder places parents at increased risk for divorce.

Detailed Description
-----------------
Autism spectrum disorders (ASDs) are lifelong neurodevelopmental disorders involving a triad of impairments in communication and social reciprocity and increases in repetitive/restricted interests and behaviors. ASD includes: autistic disorder, Asperger's syndrome, pervasive developmental disorder not otherwise specified (PDD-NOS), Rett's syndrome, and childhood disintegrative disorder as pervasive developmental disorders (American Psychiatric Association [DSM-IV-TR], 2000). Few disabilities appear to be more taxing on parents than ASDs.Parents of children with ASD fare worse on a variety of measures of well-being than parents of children without disabilities as well as parents of children with other types of disabilities. Studies investigating the impact of a child with disabilities, specifically ASD, are inconclusive. However, parents of children with ASD may be at increased risk for divorce due to a variety of personal and disability related factors. In Israel the relationship of having a child with autism on the probability of divorce has not been tested yet. The aim of this study is to profile this relationship and determine the magnitude and directionality of the effect raising ASD children has on the resilience of the institution of marriage and the satisfaction both partners derive. This will be tested using a short telephone survey.

Official Title
-----------------
Parenting a Child With Autism Spectrum Disorder and Marital Status

Conditions
-----------------
Autism Spectrum Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: parents to a child with ASD Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Parents of children with ASD<br>Parents with one or more children diagnosed with Autism Spectrum Disorder | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lower or higher levels of divorce | lower or higher levels of divorce | not relevant (phone survey) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ASD, Divorce
Postoperative Sleep Disturbances After Fast Track Hip and Knee Replacement

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to quantify the degree of sleep disturbances after hip or knee replacement surgery. Through polysomnographic monitoring the disturbances in sleep stages will be clarified.

Official Title
-----------------
Postoperative Sleep Disturbances After Fast Track Hip and Knee Replacement

Conditions
-----------------
REM Sleep Measurement

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: above 60 ASA classification I-IV Exclusion Criteria: general anaesthesia within 90 days daily use of sedatives alcohol abuse insufficient written and verbal Danish severe hearing loss and poor sight Parkinsons Disease or other functional neurological deficits Mini mental status < 24

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- | --- |
| Duration of REM sleep before and first postoperative night |  |  |
SIELLO Pilot Study for Comparison of Steroid Versus Non-Steroid Pacing Leads

Study Overview
=================
Brief Summary
-----------------
This investigation is designed to demonstrate the clinical efficacy and safety of the low-dose drug of the SIELLO leads in comparison to the non-steroid BPPU leads in a clinical investigation.

Official Title
-----------------
Pilot Study to Compare Steroid (SIELLO T/JT) Versus Non-Steroid Pacing Leads (BPPU T/JT)

Conditions
-----------------
Arrhythmias, Cardiac

Intervention / Treatment
-----------------
* Device: SIELLO JT/T
* Device: Pacemaker therapy
* Device: BPPU JT/T


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet the indications for pacemaker therapy Understand the nature of the procedure Give informed consent Able to complete all testing required by the clinical protocol Available for follow-up visits on a regular basis at the investigational site Exclusion Criteria: Meet none of the pacemaker indications Meet one or more of the contraindications Have a life expectancy of less than six months Cardiac surgery in the next six months Enrolled in another cardiac clinical investigation Have other medical devices that may interact with the implanted pacemaker

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 |
| --- | --- |
| Pacemaker therapy<br> | Device: SIELLO JT/T<br>* Implantation of SIELLO and BPPU pacemaker leads<br>* Other names: BPPU JT/T;Device: Pacemaker therapy<br>* Pacemaker therapy<br>Device: BPPU JT/T<br>* Implantation of SIELLO and BPPU pacemaker leads<br>|

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
-----------------
steroid, leads, threshold, pacemaker
Chemotherapy Related Anemia in Patients With Non-Myeloid Malignancies

Study Overview
=================
Brief Summary
-----------------
Chemotherapy can often cause anemia in patients with cancer. Anemia is a low number of red blood cells. The symptoms of anemia may include fatigue, dizziness, headache, chest pain, and shortness of breath. Erythropoietin is a hormone made by the kidneys that signals the bone marrow to produce more red blood cells. Recombinant human erythropoietin has been produced in the laboratory and has the same effect as the hormone produced by the body. Use of recombinant human erythropoietin allows the body to produce more red blood cells, possibly eliminating or decreasing your symptoms and the need for a red blood cell transfusion. Recombinant human erythropoietin is FDA approved to treat anemia in cancer patients receiving chemotherapy. This clinical study is investigating the effectiveness of darbepoetin alfa for the treatment of anemia in patients with non-myeloid malignancies who are receiving chemotherapy every three weeks. Darbepoetin alfa is a recombinant erythropoietic protein that stimulates the production of red blood cells. This medication has not been approved to treat cancer patients with anemia, however it has been approved by the FDA to treat chronic renal failure patients with anemia.

Official Title
-----------------
A Randomized, Open-Label, Dose-Timing Study of Darbepoetin Alfa Administered Once Every 3 Weeks (Q3W) by Subcutaneous (SC) Injection for Treatment of Anemia in Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy

Conditions
-----------------
Lymphoma, Breast Neoplasms, Lung Neoplasms, Multiple Myeloma, Chronic Lymphocytic Leukemia

Intervention / Treatment
-----------------
* Drug: darbepoetin alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with non-myeloid malignancies * Patients receiving at least 12 weeks of chemotherapy on a 3-week cycle schedule * Patients with anemia (hgb >/= 9.0 and </= 11.0 g/dL)

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: darbepoetin alfa|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Prediction of NODAT After Renal Transplantation

Study Overview
=================
Brief Summary
-----------------
A statistical analysis of the predictive value of OGTT and FPG testing executed as part of standard clinical practice after renal transplantation for the diagosis of new-onset diabetes mellitus after transplantation.

Detailed Description
-----------------
All patients transplanted in our department receive a formal oral glucose tolerance test (and thus also fasting plasma glucose concentration) in the first week after renal transplantation. This testing for DM or Impaired Glucose Tolerance (IGT) is part of our standard clinical protocol and data are collected prospectively in all these patients in an electronic patient medical file. The development of diabetes mellitus in all transplant patients is documented, including DM therapy.

Official Title
-----------------
Early Prediction of New Onset Diabetes Mellitus After Transplantation (NODAT) in Renal Transplantation: Use of Oral Glucose Tolerance Test (OGTT) and Fasting Plasma Glucose (FPG).

Conditions
-----------------
Renal Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary or secondary single kidney transplantation Age older than 18 years Exclusion Criteria: Pre-existing DM or documented impaired glucose metabolism Combined organ transplantation

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?
-----------------
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
-----------------
NODAT, OGTT, FPG, Renal Transplanation, Risk Factors, Predictive value
Bioequivalency Study of Montelukast 10 mg Tablets Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to prove the bioequivalence of Montelukast Tablet under fed conditions

Official Title
-----------------
A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Montelukast Sodium 10 mg Tablets Under Fed Conditions

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Montelukast
* Drug: Singulair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to montelukast or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Montelukast<br>10 mg Tablet | Drug: Montelukast<br> <br> * Other names: Singulair;|
| Active Comparator: Singulair<br>10 mg Tablet | Drug: Singulair<br> <br> * Other names: Montelukast;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioequivalence determined by statistical comparison Cmax |  | 9 days |
Human Tumor Sequencing Project

Study Overview
=================
Brief Summary
-----------------
This study is being done to learn more about genetic mutations in cancer cells and to find out how the development of new technologies can increase knowledge of these mutations and possibly predict an individual's response to certain treatments.

Official Title
-----------------
Human Tumor Sequencing Project

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of a solid tumor or blood borne cancer 18 years or older Eligible to have blood drawn

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 |
| --- | --- | --- |
| Determine biomarkers of clinical utility and copy number variants through genetic analysis. |  | four years |
Comparison of Stress Reduction Techniques

Study Overview
=================
Brief Summary
-----------------
There are many ways to reduce stress. This study will compare 2 different programs for reducing stress. In addition to looking at how well the programs reduce stress, we will also ask questions about how these programs may be working.

Conditions
-----------------
Stress

Intervention / Treatment
-----------------
* Behavioral: Program 2
* Behavioral: Program 1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 25-50 years of age Able to engage in moderate physical activity Interested in being treated for stress Exclusion Criteria: Use of psychotropic medications within 6 months prior to study. History of extreme physical or psychological trauma. Medical conditions that would interfere with study procedures or confound results, such as diabetes, pregnancy, or paralysis. Axis I psychiatric diagnosis; e.g., history of substance use disorder, psychotic disorder, bipolar disorder, or eating disorder.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 50 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Program 1<br>Program 1 | Behavioral: Program 1<br>* A well-established behavioral method for reducing stress. To maintain blinding, details will be given to participants after randomization.<br>|
| Active Comparator: Program 2<br>Program 2 | Behavioral: Program 2<br>* A well-established behavioral method for reducing stress. To maintain blinding, details will be given to participants after randomization.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Perceived Stress | Participants will complete a short questionnaire about how stressed they feel. There will be 4 time points: baseline, week 8, week 12, week 24. | baseline to 24 weeks |