linjc16/ctgov huggingface dataset:
Measurement of Bladder Pressure With a Novel External Device, Comparison to Urodynamics Testing

Study Overview
=================
Brief Summary
-----------------
The investigators have developed a novel pressure monitoring device that hooks to standard urinary catheters. The investigators will be testing how the pressure measurements recorded with this device compare to the gold standard measurement of urodynamics.

Detailed Description
-----------------
For patients with neurogenic bladder, regular monitoring of bladder pressure and capacity is a critical component of maintaining renal and urinary health. This monitoring is currently done by in-office urodynamics testing (UDS). This testing is done intermittently, leaving open the possibility of worsening of bladder function and renal deterioration between testing sessions. This study utilizes a novel pressure monitoring device which is portable and hooks to the end of a standard urinary catheter. The investigators will be investigating if this device can achieve similar pressure measurements as UDS. The investigators hope is that this device will provide similar measurements to UDS, and can be developed as a home bladder-pressure monitoring tool. This study will enroll children with neurogenic bladder who are currently undergoing UDS as part of their regular care. The measurements will be taken as part of the standard UDS protocol (with insertion of the UDS catheter) and will then be compared to the values obtained with UDS testing.

Official Title
-----------------
Measurement of Bladder Pressure With a Novel External Device, Comparison to Urodynamics Testing

Conditions
-----------------
Urinary Bladder, Neurogenic, Urodynamics

Intervention / Treatment
-----------------
* Diagnostic Test: Urodynamics Testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: must have diagnosed neurogenic bladder undergoing urodynamics testing as part of routine clinical care Exclusion Criteria: -None

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 99 Years

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

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

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 |
| --- | --- |
| Other: Neurogenic Bladder Patients<br>Patients with neurogenic bladder undergoing urodynamics testing | Diagnostic Test: Urodynamics Testing<br>* Urodynamics utilizes a small catheter to fill the bladder and continuously measure pressure and volume giving information on bladder function and compliance<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bladder Pressure | Pressure of the bladder at bladder capacity | During UDS testing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
urodynamics, neurogenic, bladder
Efficacy of Buprenorphine for Treatment of Acute Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether sublingual buprenorphine is effective in the treatment of acute pain in adult patients with extremity bone fractures

Official Title
-----------------
Comparison of Sublingual Buprenorphine With Intravenous Morphine Sulfate in Treatment of Acute Pain Due to Long Bone Fracture

Conditions
-----------------
Acute Pain

Intervention / Treatment
-----------------
* Drug: Buprenorphine
* Drug: Morphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of extremity bone fracture Age>16 years Acute pain of score 3 or greater on numerical rating scale Exclusion Criteria: Long term use of opium or opioids/dependence Previous administration of analgesic Known sensitivity to opioids Pregnant women History of medical problems (liver, kidney, heart, hematologic)

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Buprenorphine + Placebo<br> | Drug: Buprenorphine<br>* 0.4 mg, SL (sublingual) Buprenorphine PLUS 5 ml Placebo IV (in the vein)<br>|
| Placebo Comparator: Morphine + Placebo<br> | Drug: Morphine<br>* Placebo SL PLUS 5 ml Morphine sulfate (1mg/ml) IV<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain severity/score |  | After 60 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for rescue analgesia |  | After 60 min | 
| Occurrence of adverse events |  | During 60 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Buprenorphine, acute pain, analgesia
Evaluation of a Non-invasive Device to Measure Blood Pressure and Difference in Pulse Pressure (dPP) Intraoperatively

Study Overview
=================
Brief Summary
-----------------
Dynamic parameters like pulse pressure Variation (PPV) , synonymous: difference in pulse pressure (dPP), can predict fluid responsiveness reliably (Marik PE et al, Crit Care Med 2009; 37:2642-7). An arterial line is required for assessment of dPP. On a modified Penaz technique, a non-invasive measurement device is now available commercially. In this study, the reference technique based on arterial measurement and a respiratory variation monitor (Pestel G et al, Anesth Analg 2009; 108:1823-9) was compared to the non-invasive device a clinical setting. At defined time points, systolic, diastolic, mean arterial blood pressure and dPP were compared using Bland-Altmann Analysis (Bland JM, Altman DG, Lancet 1986; 1: 307-10)

Conditions
-----------------
Blood Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 and < 80 years old Written informed consent obtained Patients scheduled for elective urological or abdominal surgery procedures in supine position qualifying for arterial line Exclusion Criteria: pregnancy cardiac insufficiency (NYHA 4, EF < 25 %) coronary artery disease (CCS 4) coagulopathy symptoms of infection or sepsis malignant hyperthermia absence of sinus rhythm BMI > 30 M. Raynaud

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between arterial line and non-invasive device for blood pressure and difference in pulse pressure measurement | Systolic, diastolic, mean blood pressure and difference in pulse pressure are measured intraoperatively with a non-invasive device and the reference technique. The values are compared using Bland-Altmann Analysis. | intraoperatively |
Cytokines and Acute Phase Reactants as Markers of Pulmonary Tuberculosis Treatment

Study Overview
=================
Brief Summary
-----------------
Tuberculosis is a highly prevalent chronic infectious disease caused by Mycobacterium tuberculosis. Cytokines are important biological mediators that regulate immune and inflammatory responses against the bacilli, witch include the acute phase response. Besides this, it becomes essential to determine markers of healing lesions, once this is currently carried out based on the clinical, radiological, and negative bacterioscopy.

Detailed Description
-----------------
Tuberculosis is a highly prevalent chronic infectious disease caused by Mycobacterium tuberculosis. Cytokines are important biological mediators that regulate immune and inflammatory responses against the bacilli, witch include the acute phase response. Besides this, it becomes essential to determine markers of healing lesions, once this is currently carried out based on the clinical, radiological, and negative bacterioscopy. The propose of this work was to evaluate the production of IFN- γ in cell supernatants of peripheral blood mononuclear cells (PBMC) culture, TNF-α, IL-10 and TGF-b in cell supernatants of monocytes (MO) culture and biochemical (total proteins, albumin, globulin, α-1-acid glycoprotein and C-reactive protein) and hematological (VHS) serum parameters before and after 3 and 6 months of therapy

Conditions
-----------------
Pulmonary Tuberculosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of Mycobacterium tuberculosis infection Exclusion Criteria: all other granulomatous or neoplastic diseases

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?
-----------------
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
-----------------
Cytokines, Pulmonary tuberculosis, Mycobacterium tuberculosis, Acute Phase Response, Treatment
MEVALONATE KINASE GENE MUTATIONS AND THEIR CLINICAL CORRELATIONS IN BEHÇET'S DISEASE

Study Overview
=================
Brief Summary
-----------------
Background: Genetics is suggested to play a critical role in the development of Behçet's disease (BD). Shared phenotypic features requires an approach to the differential diagnosis from periodic febrile syndromes particularly from mevalonate kinase deficiency related diseases. We planned to study for evaluating the frequency of mutations and their clinical significance in mevalonate kinase gene in Turkish patients with Behçet's disease.

Conditions
-----------------
Behçet's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Behçet patients Exclusion Criteria: Diagnosis of periodic fever syndromes

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 |
| --- | --- |
| controls<br>frequency of mevalonate kinase gene frequency | |
| Behçet patients<br>frequency of mevalonate kinase gene mutations | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of mevalonate kinase frequency in Behçet disease |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mevalonate kinase gene and clinical correlations in Behçet's disease |  | One year |
Comparative Study Examining the Effectiveness in Use of a DERMOJET and a Normal Syringe Treatment for Patients With Hair Loss - Alopecia Areata

Study Overview
=================
Brief Summary
-----------------
Conventional treatments include the use of steroids applied locally, or injection in to the legion, or oral therapy. Treatment is determined by the severity of the disease. Injection in to the legion can be done in two methods Subcutaneous injection syringe Lower Using syringe DERMOJET - a syringe without a needle. So far there are no publications in the medical literature of studies comparing efficacy, safety, convenience of use for doctor-patient, of both methods.

Official Title
-----------------
Comparative Study Examining the Effectiveness in Use of a DERMOJET and a Normal Syringe Treatment for Patients With Hair Loss - Alopecia Areata

Conditions
-----------------
Alopecia Areata

Intervention / Treatment
-----------------
* Device: Subcutaneous injection luer syringe
* Device: DERMOJET (a syringe without a needle)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects over the age of 18 Men and women The presence of at least two lesions (centers) in diameter of at least 1.5 cm on both sides of the scalp. Healthy with no diseases that constitute the background against the total label use steroids Exclusion Criteria: Pregnant women Involvement of more then 50% of the scalp Patients with immunodeficiency-related diseases Patients receiving systemic steroids

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Subcutaneous injection luer syringe|Right scalp: Luer syringe. Left scalp: syringe without a needle. All injections will contain 0.1 ml of Depo Medrol - Methylprednisolone acetate 40 mg/2 ml. The distance between injection locations will be 1 cm.|
|Device: DERMOJET (a syringe without a needle)|Right scalp: Luer syringe. Left scalp: syringe without a needle. All injections will contain 0.1 ml of Depo Medrol - Methylprednisolone acetate 40 mg/2 ml. The distance between injection locations will be 1 cm.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of lesions will be based on Global assessment of improvement, score of 0-5 |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain level will be evaluated based on a scale of 0-10 |  | 1 year |
Treatment for Depression in the Primary Care Setting

Study Overview
=================
Brief Summary
-----------------
This study will compare a brief form of counseling to usual care for the treatment of minor depression in the primary care setting.

Detailed Description
-----------------
Minor depression is one of the most common types of depressive disorders seen in primary care. The effectiveness and tolerability of antidepressants in patients with minor depression is unclear, and the development of alternative treatments is necessary. In the first phase of this study, participants are observed for 4 weeks to identify those most in need of depression-specific treatment. Participants are then exposed to the Problem-Solving Treatment for Primary Care (PST-PC), a six-session behavioral treatment for depression. After 4 weeks, patients who do not respond adequately to the treatment are randomly assigned to either continued PST-PC or to usual care for 9 weeks. Participants are followed for 6 months after the study.

Official Title
-----------------
Problem-Solving Treatment for Primary Care Depression

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Behavioral: Problem-Solving Treatment for Primary Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary care patient at Dartmouth-Hitchcock Medical Center (DHMC) Hamilton Depression Score >= 10 and minor depression at time of entry and after 4 weeks of observation Exclusion Criteria: Psychosis, Obsessive Compulsive Disorder (OCD), or Post Traumatic Stress Disorder (PTSD) Active substance abuse Receiving treatment for depression

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 |
| --- |
|Behavioral: Problem-Solving Treatment for Primary Care|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Anomalous Self-Experience in First Episode Psychosis - A Six-Year Follow-Up Study

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to explore the longitudinal course of self-disturbances (SD) in schizophrenia. The main aim of the study is to investigate, in a 6-7-year follow-up of a representative sample of patients with first-episode schizophrenia, bipolar disorder and other psychoses. The overall aim is to expand our knowledge about the role of SDs in psychotic disorders. Increased knowledge here will aid diagnosis and treatment. The current study is a seven year follow-up of this representative cohort, with baseline measures of SDs and a comprehensive clinical and neurocognitive assessment battery.

Official Title
-----------------
Anomalous Self-Experience in First Episode Psychosis - A Six-Year Follow-Up Study

Conditions
-----------------
Schizophrenia and Disorders With Psychotic Features, Affective Disorders, Psychotic, Self Concept

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who participated and completed base-line part of the study, Patients with concurrent substance use disorder are included, but have to demonstrate at least one month without substance use, or clear signs that the psychotic disorder had started before the onset of significant substance use. Exclusion Criteria: Patients with brain injury, Patients with on going substance use, Unable to provide informed consent statement. Not able to be interviewed.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Follow-Up Group<br>An earlier investigated cohort with first episode psychosis patients from two Norwegian counties. Being between 18 - 65 years old and being consecutive in- or outpatient referred to first adequate treatment for a DSM-IV diagnosis of schizophrenia, bipolar disorder, or other psychosis. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in EASE (Examination of Anomalous Self-Experience)Total Score and Subscales of EASE |  | 6 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline for Structured Clinical Interview for the DSM ( SCID-I)(DSM-IV) |  | 6 year |
Assessment of Intravitreous Injections of Vitrase for Inducing Posterior Vitreous Detachment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy of intravitreous injections of Vitrase to induce posterior vitreous detachment(PVD) in subjects with moderate to severe non-proliferative diabetic retinopathy.

Official Title
-----------------
An Open-label Assessment of Intravitreous Injections of Vitrase (Hyaluronidase for Injection) for Inducing Posterior Vitreous Detachment in Subjects With Moderate to Severe Non-proliferative Diabetic Retinopathy

Conditions
-----------------
Vitreous Detachment, Diabetic Retinopathy

Intervention / Treatment
-----------------
* Drug: Vitrase


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderately severe to severe non-proliferative diabetic retinopathy Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) with pinhole of 20/320 or better in study eye & 20/50 or better in non-study eye. Exclusion Criteria: Contraindications or hypersensitivities to Vitrase or anesthesia Any significant illness that could be expected to interfere with trial Prior Vitrase therapy Either a past diagnosis of clinically significant macular edema (CME) in study eye that required treatment or current CME that may require focal laser treatment within the next 30 days For either eye: ongoing ocular infection, inflammation or history of herpetic corneal lesion; an intravitreous injection within 30 days; glaucoma; intraocular pressure (IOP) of less than 5mmHg; retinal detachment or ocular tumors For study eye: vascular occlusive disease of fundus; corneal, lenticular or ocular media abnormalities; a significant ocular trauma within 6 months; previous vitrectomy; any prior laser treatment, cryo-retinopexy or any intraocular surgery; either a partial or complete posterior vitreous detachment (PVD); myopia of 6 or more spherical diopters and/or axial length exceeding 26mm; significant retinal pathology

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| Experimental: Vitrase<br>A single intravitreous injection of Vitrase 93 USP Units (75 IU) on Study Day 1. | Drug: Vitrase<br> <br> * Other names: ovine hyaluronidase;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitreous detachment | The proportion of subjects achieving a complete posterior vitreous detachment by Study Day 28 | Day 28 |