linjc16/ctgov huggingface dataset:
Complementary/Alternative Medicine for Abnormality in the Vestibular (Balance) System

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the relative merits of vestibular rehabilitation and Tai Chi for patients with inner ear (vestibular) disorders.

Detailed Description
-----------------
It is proposed a randomized, blinded, controlled trial comparing vestibular rehabilitation (VR) to Tai Chi (TC). Our overall goal is to explore whether, and if so, how TC can improve functional, dynamic stability in persons with vestibulopathy (VSP). It is hypothesized that the TC group will demonstrate significantly greater improvement in performing functional activities than the VR group. Sixty subjects will be randomly assigned into either TC instruction or VR. Both treatment groups will receive identical duration treatment once a week for 10 weeks, with supplemental home exercises. It is hypothesized that 1) TC improves whole-body dynamic locomotor stability more than does VR; 2) TC improves gait coordination during planned and unplanned obstacle encounters more than does VR; 3) TC improves whole-body speed related movement control more than does VR.

Official Title
-----------------
Complementary/Alternative Medicine for Vestibulopathy

Conditions
-----------------
Vestibular Neuronitis, Vestibulopathy

Intervention / Treatment
-----------------
* Behavioral: Tai Chi


Participation Criteria
=================
Eligibility Criteria
-----------------
Main inclusion criteria: vestibulopathy and locomotor unsteadiness Main exclusion criteria: diseases/impairments that prevent rehab participation.

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Tai Chi|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
-----------------
Rehabilitation, Tai Chi
Mechanisms and Reversibility of Heart Failure Associated With Diabetes

Study Overview
=================
Brief Summary
-----------------
Patients with diabetes have a higher incidence of heart failure and worse outcomes than normoglycaemic subjects. Basic science research has suggested many mechanisms for this observation including endothelial dysfunction, abnormal calcium handling, fibrosis and activation of the renin-angiotensin-aldosterone system (RAAS), but clinical data are lacking. In this study the investigators will investigate the relationship between diabetes and heart failure by exploring the correlation between microvascular dysfunction and cardiac magnetic resonance (CMR) markers of left ventricular (LV) hypertrophy, cardiac dysfunction and fibrosis. The investigators also propose to see if this relationship is independent of blood pressure and markers of RAAS activity. This could have important clinical ramifications in type 2 diabetes by increasing the indications for treatment with RAAS inhibition or making a case for lower blood pressure targets.

Conditions
-----------------
Type 2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Exclusion Criteria: Known cardiac or renal disease Uncontrolled hypertension Treatment with ACEi/ARB Treatment with insulin Contraindication to CMR

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 |
| --- | --- |
| Diabetic with nephropathy<br> | |
| Diabetics without nephropathy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricle mass |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricle function |  | 1 year | 
| RAAS activity |  | 1 year |
Clinical Trial on Harmonic Focus Shears

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the technical benefits, advantages and limits of the use of the Harmonic Focus curved shears in total thyroidectomy.

Detailed Description
-----------------
According to a randomized sequence, total thyroidectomy was performed in 34 patients using Harmonic Focus and in 34 patients using clamp-and-tie technique. In this randomized prospective trial, differences in the duration of surgery, intraoperative bleeding and post-operative complications were analysed.

Official Title
-----------------
Harmonic Focus Shears Versus Clamp-and-technique for Total Thyroidectomy

Conditions
-----------------
Multinodular Goiter

Intervention / Treatment
-----------------
* Procedure: thyroidectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Total thyroidectomy for multinodular goiter in adults patients Exclusion Criteria: Redo surgery, malignancy.

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 |
| --- | --- |
| Harmonic Focus /conventional haemostasis<br> | Procedure: thyroidectomy<br>* Comparison between two groups of patients. One group is operated on using harmonic Focus for haemostasis compared to a second group of patients operated on with the conventional haemostasis using tie-and-clamp technique<br>|
| Harmonic Focus<br> | |
| new surgical device<br> | |
| Harmonic Focus / conventional haemostasis<br>Harmonic Focus group refers to the use of ultracision shears for haemostasis and conventional haemostasis group refers to the tie-and-clamp technique in total thyroidectomy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy, safety and potential advantages of Harmonic Focus for total thyroidectomy |  | day one after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact on bleeding, operative time, instrument exchanges, material needed for haemostasis |  | during the operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
goiter
Pediatric Ocular Trauma in Minia Governate

Study Overview
=================
Brief Summary
-----------------
The most common cause of unilateral blindness in pediatric age groups, especially in developing countries, is ocular trauma. The epidemiology of eye injuries varies in different parts of the world and different age groups and depends on many factors including life style, socioeconomic status, traffic state, sport and creative activities and type of registration and recording of data. About half a million people in the world are blind as a result of eye injuries. About 30-40% of monocular blindness is due to ocular trauma

Official Title
-----------------
Epidemiology and Visual Outcome of Pediatric Ocular Trauma

Conditions
-----------------
Pediatric Ocular Trauma

Intervention / Treatment
-----------------
* Procedure: Repair of ocular trauma in children below 16 years old


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age below 16 years Exclusion Criteria: Age above 16 years Previous ocular surgery

Ages Eligible for Study
-----------------
Maximum Age: 16 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 |
| --- |
|Procedure: Repair of ocular trauma in children below 16 years old|Diagnosis and repair of pediatric ocular trauma|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epidemiology of trauma | incidence of trauma | 2 years | 
| Visual outcome | Visual acuity | 6 months |
Molecular Epidemiology of Clostridium Difficile Infections in Children

Study Overview
=================
Brief Summary
-----------------
Objectives: Describe the molecular epidemiology of Clostridium Difficile infection in children in the Chicago area. Determine the clinical spectrum and risk factors for Clostridium Difficile infection secondary to particular endemic strains in children. Define the risk factors for recurrent and community-associated Clostridium Difficile infection in children.

Official Title
-----------------
Molecular Epidemiologic Survey and Risk Factor Assessment of Clostridium Difficile Infections in Children: A Focus on Recurrent and Community-associated Infections

Conditions
-----------------
Clostridium Difficile Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clostridium Difficile infection Exclusion Criteria: Age < 1 year Age > 18 years

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum 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 |
| --- | --- |
| Clostridium difficile infection<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clostridium Difficile Infections Strain Type Based on Restriction Endonuclease Analysis | Stool samples taken from patients with Clostridium Difficile Infections infection at the time of diagnosis will be assessed by restriction endonuclease analysis to determine strain type. In order to study the relationship between strain type and outcome of their infection (e.g, treatment failure, recurrence, complication of illness), patients will be followed throughout their illness and for 8 weeks after developing their infection. | On day 1 of diagnosis of Clostridium difficile infection |
Prophylactic Antibiotic Treatment for Laparoscopic Inguinal Hernia Mesh Repair: Necessary or Not?

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out whether it is necessary to prophylactically treat patients undergoing laparoscopic inguinal hernia repairs with antibiotics. Our hypothesis is that it is not necessary to pretreat patients with antibiotics if the operation is minimally invasive with a mesh placed at the defect.

Detailed Description
-----------------
The investigators plan to follow up at least 100 patients who did not receive antibiotics prior to their inguinal hernia repair and compare their outcome to 100 patients who did receive prophylaxis. The investigators mainly will be analyzing the incidence of surgical site infections as evidenced by swelling, redness, pain, warmth or other signs deemed by the surgeon.

Official Title
-----------------
Prophylactic Antibiotic Treatment for Laparoscopic Inguinal Hernia Mesh Repair: Necessary or Not?

Conditions
-----------------
Hernia, Inguinal

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective laparoscopic inguinal hernia repair, unilateral or bilateral Exclusion Criteria: Those requiring antibiotics for the surgery; Those patients who have experienced surgical site infections from previous surgeries

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 |
| --- | --- |
| Antibiotic Prophylaxis<br>This cohort will receive antibiotic prophylaxis prior to the hernia repair | |
| No Antibiotic Prophylaxis<br>This cohort will not receive antibiotic prophylaxis prior to the surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of surgical site infection | The investigators will interview the patient at one week, at one month, and at one year post-operation and assess for any signs of infection around the location of hernia repair. | One year post-operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inguinal hernia, Mesh repair, Prophylactic Antibiotics, Herniorrhaphy, Laparoscopic Inguinal Hernia Repair
Long-Term Study That Measures the Safety and Efficacy of Deucravacitinib (BMS-986165) in Participants With Psoriasis

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to characterize the long-term safety and efficacy of the drug Deucravacitinib (BMS-986165) in patients who have been previously enrolled in an applicable Phase 3 psoriasis study.

Official Title
-----------------
An Open-Label, Multi-Center Extension Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects With Moderate-to-Severe Plaque Psoriasis

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: BMS-986165


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completion of the protocol-required treatment period in an applicable study of BMS-986165 in moderate-to-severe psoriasis Women must not be pregnant, lactating, or breastfeeding Exclusion Criteria: Any disease or medical condition that the investigator feels that would make the patient unsuitable for this study. To be eligible for the study, a participant must not have active signs or symptoms of tuberculosis (TB) as judged by the investigator. Other protocol-defined inclusion/exclusion criteria apply

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986165<br> | Drug: BMS-986165<br>* Specified dose on specified days<br>* Other names: Deucravacitinib;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AEs) |  | Up to 244 weeks | 
| Incidence of Serious Adverse Events (SAEs) |  | Up to 244 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| static Physician Global Assessment (sPGA) 0/1 response |  | Up to 240 weeks | 
| Psoriasis Area and Severity Index (PASI) 75 response |  | Up to 240 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psoriasis
Effects of Combined Alcohol and Nitrous Oxide Intake - 15

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effects of combined alcohol and nitrous oxide intake on mood, psychomotor performance, and the pain response in healthy volunteers.

Official Title
-----------------
Effects of Combined Alcohol and Nitrous Oxide Intake

Conditions
-----------------
Opioid-Related Disorders, Substance-Related Disorders

Intervention / Treatment
-----------------
* Drug: 30% Nitrous oxide
* Other: 0.25 g/Kg ethanol
* Other: 0.5 g/KG ethanol
* Other: 0 g/Kg ethanol


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 0 g/Kg ethanol +/- 30% nitrous oxide<br> | Drug: 30% Nitrous oxide<br> <br> Other: 0 g/Kg ethanol<br> <br> |
| Active Comparator: 0.25 g/Kg ethanol +/- 30% nitrous oxide<br> | Drug: 30% Nitrous oxide<br> <br> Other: 0.25 g/Kg ethanol<br> <br> |
| Active Comparator: 0.5 g/Kg ethanol +/- 30% nitrous oxide<br> | Drug: 30% Nitrous oxide<br> <br> Other: 0.5 g/KG ethanol<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity, pain bothersomeness |  | Post inhalation | 
| Mood |  | Post inhalation | 
| Psychomotor performance |  | Post inhalation | 
| Cognitive performance |  | Post inhalation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nitrous oxide, ethanol, drug interaction, subjective effects, healthy volunteer
The STAR™ Tumor Ablation Registry

Study Overview
=================
Brief Summary
-----------------
Registry collecting data on use of The STAR™ Tumor Ablation System.

Detailed Description
-----------------
The STAR Prospective Registry is an observational registry to gather clinical safety and outcome data in patients with painful spinal metastases in the thoracolumbar spine (T1-L5) following targeted radiofrequency ablation (t-RFA) treatment with the STAR™ Tumor Ablation System.

Official Title
-----------------
The STAR™ Tumor Ablation Registry

Conditions
-----------------
Metastatic Lesions in Vertebral Bodies

Intervention / Treatment
-----------------
* Device: STAR™ Tumor Ablation System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with painful spinal metastatic lesions in thoracolumbar vertebrae (T1-L5) that will be treated with t-RFA using the STAR™ Tumor Ablation System. Have signed informed consent Exclusion Criteria: Subjects under 18 years old Subjects with heart pacemakers, or other electronic device implants Subjects intended for t-RFA in vertebral body levels C1-7

Ages Eligible for Study
-----------------
Minimum Age: 22 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 Targeted Radiofrequency Ablation (t-RFA)<br> | Device: STAR™ Tumor Ablation System<br>* Targeted Radiofrequency ablation of painful metastatic tumor in the vertebral body.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief (Numerical Rating Pain Scale), post t-RFA | measured by Numerical Rating Pain Scale (NRPS, 0-10 scale) | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain & Quality of Life Improvement (measured by the FACT G7 & Numerical Rating Pain Scale) | measured by the FACT G7 & Numerical Rating Pain Scale | 1 week, 1 month, 3 month, 6 month, 12 month |
Effects of Gonadotropin Replacement Therapy on Metabolic Parameters in Patients With Hypogonadism

Study Overview
=================
Brief Summary
-----------------
Effects of gonadotrophin replacement therapy Lipid Profile and Oxidative Stress Parameters of Patients with Idiopathic Hypogonadotropic Hypogonadism

Detailed Description
-----------------
30 male patients diagnosed with IHH and a control group of 20 healthy cases with similar age and BMI were included in the study. The levels of advanced oxidation protein products (AOPP), thiol, malondialdehyde (MDA), nitric oxide (NO) and 8-hydroxydeoxyguanosine (8-OHdG) and the levels of triglyceride (TG), total cholesterol (TC), high density lipoprotein (HDL-K), low density lipoprotein (LDL-K), Apolipoprotein A1 (ApoA1) and Apolipoprotein B100 (ApoB100) were measured before and after gonadotrophin therapy.

Official Title
-----------------
Lipid Profile and Oxidative Stress Parameters of Patients With Idiopathic Hypogonadotropic Hypogonadism and the Change of These Parameters With Gonadotropin Replacement Therapy

Conditions
-----------------
Idiopathic Hypogonadotropic Hypogonadism

Intervention / Treatment
-----------------
* Drug: human chorionic gonadotropin, human menopausal gonadotropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Serum testosterone concentration < 300ng/dL Absence of a pituitary or hypothalamic mass lesions, Presence of gonadotropin response to GnRH, - Exclusion Criteria: diabetes mellitus, arterial hypertension other hormone deficiencies -

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hypogonadotropic hypogonadism patients<br>30 patients with idiopathic hypogonadotrophic hypogonadism | Drug: human chorionic gonadotropin, human menopausal gonadotropin<br>* drug for the treatment of male hypogonadism<br>* Other names: Merional ® ARIS 75 IU;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxidative stress after hCG and HMG treatment |  | 2010-2012 | 
| HDL levels after hCG treatment |  | 2010-2012 | 
| total cholesterole levels after hCG treatment |  | 2010-2012 |
Topical Antibiotics and Intravitreous Injections

Study Overview
=================
Brief Summary
-----------------
Evaluation of efficacy of topical preoperative antibiotics in patients undergoing intravitreous injections.

Conditions
-----------------
Intravitreous, Injections

Intervention / Treatment
-----------------
* Drug: gatifloxacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: intravitreous injection Exclusion Criteria: antibiotic use

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: topical antibiotic<br>topical gatifloxacin 4 times per day | Drug: gatifloxacin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive Culture | The percentage of patients with a positive bacterial culture following administration of study treatment is presented. | Study day 1, assessed following administration of study treatment |