linjc16/ctgov huggingface dataset:
Peritubal Infiltration of Bupivacaine in PCNL

Study Overview
=================
Brief Summary
-----------------
Patients may feel significant pain at the surgery site after they wake up from the surgery. Usually pain is managed in the ward by giving strong pain medication that may slow down your mobilization and recovery process. Some recent work in other countries has shown that if investigator give patients an injection at the end of the operation, patients have less need for pain medication when they wake up. If investigator find that is also true in our population, then we can use this method as routine step after this operation to improve pain management and early mobilization of our patients

Official Title
-----------------
Role of Peritubal Infiltration of 0.25% Bupivacaine in Percutaneous Nephrolithotomy (PCNL) in Postoperative Pain Control

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Bupivacaine
* Other: Normal saline infiltration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-60 years of age Single PCNL track Exclusion Criteria: Spinal Disc Prolapse Any previous renal surgery Complication secondary to PCNL Hydrothorax that requires intervention Pneumothorax Massive hemorrhage that requires more than 1 U transfusion Conversion to open procedure.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bupivacaine infiltration<br>10 ml of 0.25 % Bupivacaine | Drug: Bupivacaine<br>* 23 G spinal needle will be introduced along the nephrostomy tube for peri-tubal infiltration of 10 ml of 0.25 % Bupivacaine into renal capsule to skin.<br>|
| Placebo Comparator: Normal saline infiltration<br>10 ml of normal saline | Other: Normal saline infiltration<br>* 23 G spinal needle will be introduced along the nephrostomy tube for peri-tubal infiltration of 10 ml of normal saline into renal capsule to skin<br>* Other names: normal saline;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean time for first demand of rescue analgesic | Mean time for first demand defined as the difference in time between the first time rescue medications is given to patient in post-operatively and the time the infiltration took place intra-operatively | Release of the patient from the hospital or 24 hours (whichever comes first) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Percutaneous nephrolithotomy, postoperative analgesia, peritubal block, pain, Visual Analog Pain Scale
Adherence, Efficacy and Tolerance of Once-a-day Nevirapine-based Regimen in HIV-1 Infected Patients

Study Overview
=================
Brief Summary
-----------------
Taking antiretrovirals once-a-day is considered the simpler way to improve adherence. However, it is not know if this assertion apply to patients taking their medication twice-a-day who change to once-a-day. We hypothesized that once-daily dosing improves adherence.

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Behavioral: Nevirapine from twice-a-day to once-a-day


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-1 infected adults receiving antiretroviral therapy including nevirapine twice-a-day for at least 6 months plasma HIV RNA<400 cp/ml during the previous 4 months on 2 occasions accept adherence electronic monitoring written informed consent signed Exclusion Criteria: asparate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5N if hepatitis virus B or C were negative AST or ALT>1.25N if hepatitis virus B or C were positive

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: Nevirapine from twice-a-day to once-a-day|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MEMS adherence by electronic devices |  | 28-week period (randomized phase) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Virologic efficacy (RNA HIV<400cp/ml) |  |  | 
| Immunologic efficacy (CD4 count cells) |  |  | 
| Tolerance (hepatic, cutaneous, ANRS safety grade scale) |  |  | 
| Pharmacokinetics (nevirapine dosages) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Once-a-day, Adherence, Nevirapine, Patient noncompliance, Administration and dosage, Treatment Experienced
Photon/Proton Radiation Therapy for Cancers of the Nasal Cavity and/or Paranasal Sinuses

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect information from a questionnaire and medical records to see what effects proton radiation has on cancer and collect and analyze morbidity outcomes: incidence of Xerostomia (dry mouth) and tumor control.

Detailed Description
-----------------
The study is non interventional outcomes protocol designed to collect information from a questionnaire and medical records to see what effects proton radiation has on cancer and collect and analyze morbidity outcomes: incidence of Xerostomia (dry mouth) and tumor control.

Official Title
-----------------
A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Cancers of the Nasal Cavity and/or Paranasal Sinuses

Conditions
-----------------
Cancers of Nasal Cavity, Cancers of Paranasal Sinuses

Intervention / Treatment
-----------------
* Other: Xerostomia questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cancer of nasal cavity and/or paranasal sinuses. Will receive treatment with proton radiation. Exclusion Criteria: Evidence of distant metastasis. Previous radiation for head and neck cancer.

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 |
| --- | --- |
| Xerostomia Questionnaire<br>All of the tests, procedures and treatments may be considered standard of care for someone with this type of cancer, except for the Xerostomia Questionnaire. | Other: Xerostomia questionnaire<br>* All of the tests, procedures and treatments may be considered standard of care for someone with this type of cancer, except for the Xerostomia Questionnaire.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade 3 or higher of xerostomia Incidence of Xerostomia |  | One year after the end of radiation therapy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect and analyze tumor control outcomes |  | When each patient has been followed for a minimum of 12 months with final analysis after 24 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nasal Cavity, Paranasal Sinuses, Proton Radiation, Outcomes
Effects of Colloid and Crystalloid on the Microcirculatory Alterations During Off-pump Coronary Artery Bypass Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effects of crystalloid and colloid, which are used for pump priming solution, on the microcirculatory alterations during cardiac surgery.

Conditions
-----------------
Cardiac Surgery

Intervention / Treatment
-----------------
* Drug: plasmalyte solution
* Drug: Hextend


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Off-pump Coronary Artery Bypass Surgery Exclusion Criteria: Infection Postoperative use of steroid Liver cirrhosis, Child-Pugh C Renal disease on hemodialysis Patients who cannot receive vascular occlusion test (severe peripheral vascular disease, arteriovenous fistula, burn) EF < 40% on the preoperative echocardiography Preoperative use of vasopressors or inotropic agents

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Plasmalyte solution<br>Plasmalyte solution infusion to meet the fluid requirements. | Drug: plasmalyte solution<br>* plasmalyte solution<br>|
| Experimental: Hextend<br>6% Hetastarch administeration instead of crystalloids until the total amount given reached 20 ml/kg, which is the maximally allowed daily dose. Afterward, plasmalyte solution infusion to meet the fluid requirements. | Drug: Hextend<br>* Hetastarch administration instead of crystalloids until the total amount given reached 20 ml/kg, which is the maximally allowed daily dose. Afterward, plasmalyte solution infusion to meet the fluid requirements.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery slope | Recovery slope is a marker of microcirculation. The tissue oxygen saturation (StO2) using InspectraTM StO2 (Hutchinson Technology Inc.,USA) will be recorded continuously. The InspectraTM StO2 probe will be placed on the skin of the thenar eminence and the blood pressure cuff will be wrapped around the arm. After performing vascular occlusion test, the recovery slope will be calculated by the software. | until 2 days after surgery | 
| syndecan-1 | marker of glycocalyx degradation | until 2 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lactate |  | until 2 days after surgery | 
| StO2 (tissue oxygen saturation) |  | until 2 days after surgery | 
| Cytokine | Interleukin (IL)-1b, IL-6, IL-8, IL-10, TNF-a | until 2 days after surgery |
Study of Pathways Curriculum for Use With WPD

Study Overview
=================
Brief Summary
-----------------
Study to assess the efficacy of a modified Pathways curriculum in treating depressive symptoms in women with physical disabilities.

Official Title
-----------------
Women Physical Disability and Depression: Communities Responding Now!

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

Intervention / Treatment
-----------------
* Behavioral: Pathways


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with physical disability requiring accommodation for major mobility limitations CES-D score of 16 or higher - Exclusion Criteria: Active suicidality Diagnosis of Schizophrenia, Schizoaffective D/O, Psychosis NOS Currently receiving other psychotherapy -

Ages Eligible for Study
-----------------
Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>Control group | Behavioral: Pathways<br>* Strength-based curriculum addressing depression in women with with physical disabilities<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Center for Epidemiologic Studies Depression Scale (CES-D) |  | pre-test, post-test weeks, 12, 18, 24 |
Framingham Offspring Study: Psychosocial Risk Factors

Study Overview
=================
Brief Summary
-----------------
To examine the relationship between psychosocial characteristics, health behaviors, and the development of coronary heart disease among participants in the Framingham Offspring Study.

Detailed Description
-----------------
DESIGN NARRATIVE: Unique data sets of social, psychological, and behavioral measures were collected at the third examination of the Offspring Study from 1984 through 1987 (which results in 14 to 17 years of follow-up). Hypotheses for this research are focused toward understanding the sex and age differences in the effects these variables have on health endpoints. The research questions involve the prediction of three separate endpoints: incidence of coronary heart disease; the incidence and prognosis of atrial fibrillation; and total mortality. The analyses of psychosocial predictors for these outcomes are divided into four conceptual areas: 1) occupational status and strain, income, and employment status; 2) type A behavior, expressions of anger, hostility, and rate; 3) symptoms of depression, tension, anxiety, and feelings of aloneness; and 4) marital relationships and marital strain. These psychosocial variables will be analyzed jointly with the physiological risk factors collected at the same time to assess independence and interaction of effects. To date these psychosocial data have not been analyzed or published. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Coronary Disease, Heart Diseases, Depression, Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- | --- |
Trial of Excision Versus Photodynamic Therapy in the Treatment of Bowen's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify the most optimal therapy for Bowen's disease: excision versus Photodynamic therapy.

Detailed Description
-----------------
The study is a randomized clinical trial in which two treatment options for Bowen's disease, excision and photodynamic therapy, are compared on recurrence rate, cosmesis en expenses.

Official Title
-----------------
A Randomized Clinical Trial of Excision Versus Photodynamic Therapy in Bowen's Disease

Conditions
-----------------
Bowen's Disease

Intervention / Treatment
-----------------
* Procedure: excision
* Procedure: Photodynamic therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Histological proven Bowen's disease on scalp, face, trunk, arms and legs Informed Consent Exclusion Criteria: Recurrent Bowen's disease Anogenital or subungual Bowe's disease Other skin malignancy in the same area Porphyria

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Excision | Procedure: excision<br>* excision 3 mm margin<br>|
| Active Comparator: 2<br>Photodynamic therapy | Procedure: Photodynamic therapy<br>* Photodynamic therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence rate |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cosmetic outcome |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment, Excision, Photodynamic therapy, Recurrence rate, Cosmetic outcome
Improving Provider Counseling Interventions in HIV Practice

Study Overview
=================
Brief Summary
-----------------
Hypothesis: HIV clinicians trained to deliver brief counseling messages and receiving cues from a brief computer survey on risk behaviors of their patients can counsel have an impact on patient's risk behaviors.

Detailed Description
-----------------
This is a randomized controlled study. The purpose of this study is to assess the impact of the cue sheet as an aid to targeted provider behavioral counseling. All enrolled participants are HIV+ adults seen for regular medical care at a site affiliated with the Johns Hopkins AIDS Service. After consenting, participants will take an audio-assisted computer interviews to collect patient risk assessment data. For participants randomized to the intervention arm, the printed output on risk behaviors is then given to the provider along with cues for staged-based counseling for use during the same visit. Participants in the control arm take the same computerized risk assessment but there are no printed cue sheets. Risk behaviors of all participants are assessed at entry, at 6 months, and at 12 months. The main outcome measure is change in HIV transmission behaviors at 12 months for those in the intervention arm compared to the control arm.

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Behavioral: Stage based counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV seropositive English speaking Exclusion Criteria: Cannot give 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Provider receives cue sheet to assist with counseling. | Behavioral: Stage based counseling<br> <br> |
| No Intervention: 2<br>Provider does not receive cue sheet. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disclosure of HIV status to sex partners; unprotected sexual encounters. |  | 12 months |
Physiopathological Study of Autonomic Failure in Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the autonomic failure in Parkinson's disease by clinical, electrophysiological and neuropathological examination.

Official Title
-----------------
Physiopathological Study of Autonomic Failure in Parkinson's Disease : a Monocentric Study

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Other: Biopsies of peripheral autonomic nervous system
* Other: Autonomic dysfunction questionnaires
* Other: Electrophysiological tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Parkinson's disease ages 45 to 80 years, both genders patients who signed informed consent Exclusion Criteria: autonomic function modifying treatment pre-existing neuropathy or risk factors for neuropathy dementia colonic disorders coagulation disorders (may be due to treatment)

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Biopsies of peripheral autonomic nervous system|nan|
|Other: Autonomic dysfunction questionnaires|nan|
|Other: Electrophysiological tests|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate association between clinical autonomic failure and neuropathological autonomic failure on biopsies. | the main objective is to look after associations between : anatomopathological signs of autonomic nervous system disorders seen on biopsies AND clinical signs of signs of autonomic nervous system disorders seen through functional tests or through symptoms indicated by the patient on questionaries. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate association between autonomic failure and severity factors in Parkinson's disease | Autonomic failure will be assessed through questionaries on symptoms and through functional tests. Severity factors in parkinson disease will refer to various parameters like patient age. | 3 months | 
| Evaluate consequences of autonomic failure on quality of life and sleep quality | quality of life and of sleep will be assessed through functional tests and through questionaries. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autonomic failure, Parkinson's disease, electrophysiological assessment, neuropathological assessment