linjc16/ctgov huggingface dataset:
Safety and Efficacy of a Device for the Relief of Pain Due to Carpal Tunnel Syndrome

Study Overview
=================
Brief Summary
-----------------
Interventional study to evaluate efficacy and safety of an active splint.

Official Title
-----------------
Safety and Efficacy of a Device for the Relief of Pain Due to Carpal Tunnel Syndrome

Conditions
-----------------
Carpal Tunnel Syndrome

Intervention / Treatment
-----------------
* Device: CTR device (tradename named Xtend)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients, above 40 years of age. Able to understand and sign informed consent Pain associated with mild to moderate carpal tunnel syndrome in a single wrist Numbness and tingling in the median nerve distribution Nocturnal Numbness Weakness and/or atrophy of the thenar musculature Demonstrate positive Phalen's Test of the affected extremity Demonstrate positive Tinel's Test of the affected extremity Sensory impairment defined as a loss of 2-point discrimination Have recent (within 3 months) electro-diagnostic evidence of Carpal Tunnel Syndrome Exclusion Criteria:• Currently receiving treatment for carpal tunnel syndrome History of surgical carpal tunnel release Pregnancy Diabetes not controlled by medication Radiculopathy i.e., cervical radiculopathy, diabetic radiculopathy Thoracic outlet syndrome Compromised skin integrity Past history of traumatic event, surgery, or congenital impairment of the forearm, wrist, or hand

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

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

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

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: Intervention<br> | Device: CTR device (tradename named Xtend)<br>* Non invasive active splint<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in pain score | Reduction in NRS reported pain score | 10 weeks |
Intraocular Pressure Changes Associated With Tracheal Extubation: Comparison of Sugammadex With Conventional Reversal of Neuromuscular Blockade

Study Overview
=================
Brief Summary
-----------------
The aim of this study, comparison of effects of sugammadex versus neostigmine/atropine combination on hemodynamic parameters and intraocular pressure during tracheal extubation. This prospective, randomised study was designed to compare two reversal methods with respect to changes in IOP, heart rate and blood pressure during tracheal extubation period.

Conditions
-----------------
Intraocular Pressure Changes During Tracheal Extubation

Intervention / Treatment
-----------------
* Drug: sugammadex
* Drug: neostigmine+atropine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-II physical status elective surgery endotracheal intubation under general anesthesia Exclusion Criteria: emergency surgery pregnancy laparoscopic surgery prone position BMI > 30 kg/m2 sedative drug use in last month patients with glaucoma. ASA > II physical status

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sugammadex<br> | Drug: sugammadex<br>* sugammadex 2 mg/kg<br>|
| Active Comparator: neostigmine + atropine<br> | Drug: neostigmine+atropine<br>* neostigmine 0,05 mg/kg + atropine 0,025 mg/kg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraocular pressure |  | baseline, before applying reversal agent, after applying reversal agent, one, three, five and ten minutes after tracheal extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate |  | baseline, before applying reversal agent, after applying reversal agent, one, three, five and ten minutes after tracheal extubation | 
| blood pressure |  | baseline, before applying reversal agent, after applying reversal agent, one, three, five and ten minutes after tracheal extubation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
two reversal methods, changes in IOP, heart rate, blood pressure, tracheal extubation
The Functional Profile of People Suffering From Trigger Finger

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to Characterize the population of people who suffer from trigger finger (TF) in terms of demographic (Gender, age, occupation, etc.); motor skills (hand function); the Consequences of the disease on a person's daily functioning and impact on quality of life. The study will also attempt to examine the suitability of several common assessment tool for evaluation of hand rehabilitation Patients who suffer from TF. Information obtained from the study will enable a deeper comprehension of the consequences of TF on the patient and will be the first step in developing a protocol assessment and evidence-based treatment in this population.

Official Title
-----------------
Functional Profile of People Suffering From Trigger Finger

Conditions
-----------------
Trigger Finger

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 20 and above. Men and Women. diagnosed with Trigger Finger. Exclusion Criteria: Trauma in upper Extremity. Cognitive difficulties that are blocking the ability to answer the questionnaires (dementia, head injury). Pregnant women. participants who didnt completed all Assessments.

Ages Eligible for Study
-----------------
Minimum Age: 20 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
-----------------
Trigger Finger
Evaluation of Hemodynamics and Amount of Blood Flowing Through the Kidneys by Measuring Some Physiological Substances in Blood and Urines

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to verify any existing relationship between mixed oxygen saturation (from central venous catheter) and urinary sodium, potassium, chloride in determining the volemic state and renal perfusion of patients undergoing major surgical interventions.

Official Title
-----------------
Hemodynamic Indexes and Renal Perfusion: Indirect Evaluation of Blood Volume Using the Association Between ScvO2 and Urinary Electrolytes in Patients Undergoing Major Surgery.

Conditions
-----------------
Hypovolemia, Renal Hypoperfusion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: thoracic-abdominal major surgical operations placing of a central venous catheter and urinary catheter age 18-75 ASA class I-III Exclusion Criteria: age above 75 or under 18 ASA class IV trauma, sepsis and/or heart-lung failure liver transplantation kidney transplantation pre-existing renal failure pregnant patients patients unable to give their written consent

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 |
| --- | --- | --- |
| Determination of mixed oxygen saturation in central venous blood (ScvO2) and three urinary electrolytes (sodium, potassium, chloride) |  | During the stay of the patient in the operating room (in average 6 hours) and the eventual stay in the post-surgery intensive care unit (in average 1 day) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypovolemia, renal hypoperfusion, major surgery, sodium, potassium, chloride, ScvO2, hemodynamic indexes
Safety Study of DIPG Treatment With Autologous Dendritic Cells Pulsed With Lysated Allegenic Tumor Lines

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to asses safety of diffuse intrinsic pontine glioma (DIPG) treatment with autologous dendritic cells pulsed with lysated allegenic tumor lines Evaluate the nonspecific immune response generated in peripheral blood and Cerebral Spinal Fluid (CSF) by proposed treatment Evaluate the specific antitumor immunity response generated in peripheral blood and CSF Assess overall survival and progression free survival Correlate the neuroradiological changes with the clinical course and immune response generated in peripheral blood and CSF Quality of life evaluation

Official Title
-----------------
Phase Ib Clinical Trial on the Safety of Immunotherapy With Autologous Dendritic Cells Primed With Lysate Allogeneic Tumor Lines in Patients With Diffuse Intrinsic Pontine Glioma (DIPG)

Conditions
-----------------
Diffuse Intrinsic Pontine Glioma

Intervention / Treatment
-----------------
* Biological: Autologous dendritic cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed DIPG Patients without progressive disease Aged between 3 and 18 yo Lansky scale >50 (Karnofsky for patients aged more than 16 yr) Life expectancy > 8 weeks Preserved bone marrow function Normal hepatic and renal function Exclusion Criteria: Impossibility to perform aphaeresis Patient participation of other experimental study within the last 3 months Patient under antitumor treatment in the last 4 weeks Co-morbidity that does not allow the study treatment Patients requiring > 2mg/day of dexamethasone treatment Corticoid-dependent patients Patients under uncontrolled infection Positive serologies of HIV, hepatitis C virus (HCV) or hepatitis B virus (HBV)

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 18 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: Autologous dendritic cells<br> | Biological: Autologous dendritic cells<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of serious adverse events per patient (after treatment administration |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival Progression free survival |  | 1 year | 
| Time to first Serious Adverse Event (SAE)(after treatment) |  | 1 year |
Near-Infrared Spectroscopic (NIRS) Tissue Oxygen Saturation and the Vascular Occlusion Test in Cardiac Surgery Patients

Study Overview
=================
Brief Summary
-----------------
Tissue oxygen saturation (StO2) and its recovery during a vascular occlusion test (VOT) will be measured in elective cardiac surgery patients undergoing cardiopulmonary bypass using a non-invasive near infrared spectrometry (NIRS) machine. The purpose of this study is to determine whether changes in VOT measurements occur in patients during cardiac surgery.

Conditions
-----------------
Vascular Occlusion Test

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult, elective cardiac surgery patients Procedure using cardiopulmonary bypass Exclusion Criteria: Contraindication to pneumatic cuff inflation Pregnant Significant peripheral vascular disease of the arms Emergency surgery

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 |
| --- | --- |
| VOT on bypass<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VOT reperfusion slope | Reperfusion slope as measured during vascular occlusion test in units of %/s | Intra-operative (within 12 hours) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Regional tissue oximetry, Cardiopulmonary bypass, Cardiac surgical procedures
Randomized Controlled Trial Comparing MBSR to SET in Breast Cancer Patients

Study Overview
=================
Brief Summary
-----------------
This study will compare three standard treatment programs commonly offered to patients with breast cancer. The three programs being compared are 1) Mindfulness Meditation-Based Stress Reduction (MBSR), 2)Supportive- Expressive Group Therapy (SET), and 3) A one day stress-management seminar. The purpose of this study is to determine if these three treatments have different effects on psychological well-being, the immune system, and the amount of stress hormones in the bloodstream.

Official Title
-----------------
Randomized Controlled Trial Comparing Mindfulness-Based Stress Reduction (MBSR) to Supportive-Expressive Therapy (SET) on Psychological and Biological Outcomes in Breast Cancer Patients

Conditions
-----------------
Breast Neoplasms

Intervention / Treatment
-----------------
* Behavioral: Mindfulness Meditation-Based Stress Reduction
* Behavioral: Supportive-Expressive Group Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Study participants must be women diagnosed with Stage I, II, or III breast cancer within the previous 18 months, have completed all treatments with the exception of hormonal therapy at least three months previously, over the age of 18, and have a score of 13 or higher on the BSI-18. Previous meditation/yoga experience is allowed but will be recorded. Exclusion Criteria: Participants must not have a concurrent DSM-IV diagnosis of psychosis, substance abuse, bipolar disorder, or active suicidality (as assessed by structured clinical interview), must not be currently using psychotropic medications (antipsychotics, antidepressants, anxiolytics), have a concurrent autoimmune disorder, or have participated previously in MBSR or SET group.

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Mindfulness Meditation-Based Stress Reduction|nan|
|Behavioral: Supportive-Expressive Group Therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological:mood, stress, post-traumatic growth, social support, quality of life, spirituality |  |  | 
| Physical:cortisol levels (stress hormone) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| emotional repression |  |  | 
| personality |  |  | 
| emotional suppression |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stress, breast neoplasms, personality, psychology
Triple BRAFinh/MEKinh /antiPD1 Combined Therapy in Patients With BRAF Mutated Melanoma With Central Nervous System Metastasis

Study Overview
=================
Brief Summary
-----------------
Currently, therapeutic options in BRAF mutated melanoma with brain metastasis occurring after achievement of a good control of extracerebral secondary lesions by a first line combined targeted therapy (TT) are limited. In this setting, the addition of an anti PD1 agent to TT may be proposed as a second line strategy. This observational survey aims at investigating the benefit/risk ratio of this triple combination in a small cohort of patients.

Official Title
-----------------
Analysis of Efficiency and Tolerance of Triple BRAFinh/MEKinh /antiPD1 Combined Therapy in Patients With BRAF Mutated Melanoma With Central Nervous System Metastasis Occuring During First-line BRAFinh/MEKinh Therapy.

Conditions
-----------------
Metastatic Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Metastatic melanoma BRAF mutated Initially treated by a doubled targeted therapy anti BRAF/anti MEK With an intra cerebral progression of the tumor Whom we add an check point inhibitor anti PD1, combined with the double targeted therapy between 01/2019 et 01/2022 Exclusion criteria: - Other condition

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 |
| --- | --- | --- |
| comparison between intra and extra cerebral metastasis | comparison between intra and extra cerebral metastasis | day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Initially treated by a doubled targeted therapy anti BRAF/anti MEK, immunotherapy, combined tritherapy, melanoma's brain metastasis, With an intra cerebral progression of the tumor
Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy

Study Overview
=================
Brief Summary
-----------------
The majority of kidney stones are treated with shock wave lithotripsy (SWL). We are examining if the medication Flomax will result in improved stone passage rates following SWL.

Detailed Description
-----------------
Placebo blinded study examining the effects of Flomax on stone passage rates following SWL.

Official Title
-----------------
Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy

Conditions
-----------------
Urolithiasis

Intervention / Treatment
-----------------
* Drug: Flomax
* Drug: Sugar pill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years old and above with urolithiasis scheduled for shock wave lithotripsy. Exclusion Criteria: Contraindications to Flomax Patients with renal impairment (serum creatinine above 2.0) Patients with hepatic impairment (liver enzymes 2.5 times the upper limit of normal) Use of other oral alpha blockers

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 |
| --- | --- |
| Experimental: Flomax<br>Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure. | Drug: Flomax<br>* 0.4mg Flomax pills will be given to patients to take once daily for one month following shock wave lithotripsy to aid the stone passage.<br>* Other names: Tamsulosin;|
| Placebo Comparator: Sugar pill<br>Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure. | Drug: Sugar pill<br>* Comparable sugar pills will be given to the placebo group to take daily for one month following shock wave lithotripsy to aid stone passage.<br>* Other names: Placebo pill;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Passage of Stone Fragments | Time to passage of stone fragments following shock wave lithotripsy as documented by patient diaries and follow-up radiographic imaging. | 2 weeks and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical Evaluation | Evaluation of pain assessments, lower urinary tract symptoms, side effects of study medication and need for hospitalizations and additional endoscopic procedures. | 2 weeks and 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
urolithiasis