linjc16/ctgov huggingface dataset:
Clinical Trial on Harmonic Focus Shears Versus Ligasure Small Jaw and Clamp-and-tie Technique for Total Thyroidectomy

Study Overview
=================
Brief Summary
-----------------
The Harmonic Focus and Ligasure small-Jaw are the last device designed for thyroid surgery. The aim is to assess: 1. decrease of operative time (minutes); 2. decrease of post-operative blood loss (milliliters); 3. decrease of post-operative stay (days); decrease of post-operative complications (%, hypocalcemia, laringeal nerve demage), compared to traditional dissection in a prospective randomized trial of total thyroidectomy procedures, for benign disease.

Detailed Description
-----------------
A single-blinded prospective randomized controlled trial was conducted at a tertiary referral center. A total of 120 patients who required a thyroidectomy for thyroid benign disease, will be randomized to either Harmonic Focus or Ligasure small-Jaw or clamp-and-tie technique during thyroidectomy. The operative time (minutes), morbidity rate (%), post-operative blood loss (milliliters), hospital stay (days), post-operative hypocalcemia (%), and cost of thyroidectomy (euros) were compared between the three groups.

Conditions
-----------------
Benign Thoroid Disease Requiring Total Thyroidectomy

Intervention / Treatment
-----------------
* Procedure: Total Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic Focus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: thyroid benign disease Exclusion Criteria: malignant disease thyroid malign disease requiring lymphadenectomy coagulatory disease
Sexes Eligible for Study
-----------------
All

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ligasure Small-JAW<br> | Procedure: Total Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic Focus<br> <br> |
| Active Comparator: Harmonic Focus<br> | Procedure: Total Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic Focus<br> <br> |
| Active Comparator: Clamp-and-Tie technique<br> | Procedure: Total Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic Focus<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of post-operative outcomes (morbidity, hospital stay, costs) with new generation devices for total thyroidectomy. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost assessment of new generation devices in thyroid surgery |  |  |
POEM- Peroral Endoscopic Myotomy for Esophageal Motility Disorders

Study Overview
=================
Brief Summary
-----------------
POEM has recently described as an alternative treatment for achalasia in humans. In this procedure the esophageal sphincter is incised through a submucosal tunnel in the esophagus. In this study we aim to perform POEM on achalasia patients.

Official Title
-----------------
POEM a Novel Endoscopic Treatment for Achalasia

Conditions
-----------------
Achalasia

Intervention / Treatment
-----------------
* Procedure: POEM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Achalasia whom are candidates for Heller Myotomy Exclusion Criteria: Perforation of LES during dilatation Pregnant women mentally ill patients

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: POEM procedure<br>Patients with achalasia that undergo POEM | Procedure: POEM<br>* Per Oral Endoscopic Myotomy for achalasia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of dysphagia |  | up to 6 months postoperatively |
Child Health Improvement Through Computer Automation of Constipation Management in Primary Care

Study Overview
=================
Brief Summary
-----------------
This project seeks to expand an existing computerized decision support system used in pediatric primary care. The expanded system will add a module that helps clinicians recognize constipated children and then provides evidence-based reminders for constipation management, as well as automates patient educational materials. The current system is deployed across multiple sites, and the constipation module will be randomized to deployment in different sites. The difference in constipation management and patient outcomes will then be compared between sites receiving the intervention and sites not receiving the intervention over a 12 month period.

Official Title
-----------------
Child Health Improvement Through Computer Automation of Constipation Management in Primary Care

Conditions
-----------------
Constipation, Encopresis

Intervention / Treatment
-----------------
* Other: Evidence Based Constipation Reminders


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting to one of 5 primary care clinics in the Eskenazi Health system in Indianapolis, IN. Patients given a pre-screener form as part of the existing CHICA decision support system. Age between 2 years and 12 years, inclusive. Exclusion Criteria: None.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 12 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Patients are identified by the pre-screener form given to parents as having constipation or encopresis. No intervention is given to providers to help them with constipation management. | |
| Experimental: Experimental<br>Patients are identified by the pre-screener form given to parents as having constipation or encopresis. Evidence based reminders and patient educational materials are given to providers to help them with constipation management. | Other: Evidence Based Constipation Reminders<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Persistent Constipation Within 6 Months | Parents are asked if constipation is still present at a subsequent visit within 6 months. | All visits within 6 months of initial constipation complaint. |
Silybin - Vitamin E- Phospholipids Complex Reduces Liver Fibrosis in Patients With Chronic Hepatitis C Treated With Peg-IFN-a and RBV

Study Overview
=================
Brief Summary
-----------------
Chronic hepatitis C is both a virologic and a fibrotic disease, with mortality resulting mainly from the complications of cirrhosis and HCC. The investigators' aim will be to evaluate the impact on of supplementation with a new pharmaceutical complex of silybin-vitamin E-phospholipids in patients with chronic hepatitis C treated with Pegylated-Interferon-α2b plus Ribavirin.

Conditions
-----------------
Liver Fibrosis

Intervention / Treatment
-----------------
* Drug: Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg complex
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older, infection by HCV under treatment with pegylated interferon 2 alpha and ribavirin Exclusion Criteria: other liver diseases cancer severe jaundice pulmonary and renal chronic diseases prostatic diseases autoimmune diseases diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Silybin + vitamin E + phospholipids complex<br>Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg in one pill per day for 12 months | Drug: Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg complex<br> <br> |
| Placebo Comparator: sugar pill<br>one placebo pill per day for 12 months | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| transforming growth factor beta | serum marker of liver fibrosis | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hyaluronic acid | serum marker of liver fibrosis | 12 months |
Evolution of Psychoactive Substances Consumption in Connection With COVID-19 Containment

Study Overview
=================
Brief Summary
-----------------
The current containment linked to COVID-19 will have consequences for people suffering from addiction and there is a risk of overdoses when the containment ends. So the investigators hypothesize that this health crisis is an opportunity to develop risk reduction and access to care for vulnerable people who lives with an addiction. The main objective of this study is to describe the changes in the psychoactive substances consumption during the containment in people suffering from addiction. The secondary objectives are to describe the evolution at 1 month from the end of the containment of problematic consumption and the level of access to care of these users

Official Title
-----------------
Evolution of Psychoactive Substances Consumption in Connection With COVID-19 Containment - EPILOGUE

Conditions
-----------------
Addiction, Substance, COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: >18 years Accept study live with an addiction Exclusion criteria: - not being able to answer the questionnaire

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 |
| --- | --- | --- |
| Evolution of consumption | measurement of the difference in drugs consumption caused by containment (delta) | 1 day | 
| Evolution of consumption | measurement of the difference in drugs consumption caused by containment (delta) | 1 month after confinmant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| health care access | number of drug users referred to care (%) | 1 day | 
| health care access | number of drug users referred to care (%) | 1 month after confinmant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Risk of overdose on de-confinment, COVID-19 containment will change drugs practices, COVID-19 containment will changes access to care, Addiction is a common disease, Alcohol, Containment, Drug use
The Effect of Orthosis and Exercise in Pes Planus

Study Overview
=================
Brief Summary
-----------------
There is no definite evidence for the conservative treatment of pes planus. We want to verify the combination efficacy of orthosis and toe walking exercise for the treatment of pes planus.

Detailed Description
-----------------
Observation cohort study We prescribe UCBL orthosis and teach toe walking exercise. And we will check standing foot radiography (AP/Lateral) annually. And we will compare the changes of talometatarsal angle and calcaneal pitch angle.

Official Title
-----------------
The Effect of Orthosis and Exercise in Pes Planus

Conditions
-----------------
Pes Planus

Intervention / Treatment
-----------------
* Device: UCBL orthosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically diagnosed with pes planus Calcaneal pitch angle < 15 degree Exclusion Criteria: peripheral neuropathy infection rheumatoid arthritis operation history

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 10 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
Interventional Model Description: Annual evaluation after applying UCBL and exercise treatment. Cohort study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group<br>Treatment with UCBL and exercise therapy | Device: UCBL orthosis<br>* toe walking exercise<br>* Other names: Exercise;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TM angle | Talometatarsal angle | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CP angle | Calcaneal pitch angle | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pes planus, UCBL, exercise
Far Infrared Radiation for Sickle Cell Pain Management

Study Overview
=================
Brief Summary
-----------------
Most patients with sickle-cell disease have periodic intensely painful episodes. To manage this pain, we are proposing the drinking of at least 500 mL of water followed by far infrared radiation.

Detailed Description
-----------------
Painful sickle cell crises are treated with hydration and analgesics. Ischemia is an absolute or relative shortage of the blood supply to an organ. Relative shortage means the mismatch of blood supply (oxygen delivery) and blood request for adequate oxygenation of tissue. It is hereby postulated that far infrared radiation of the body will promote blood and oxygen supply to the affected tissues. In addition, the analgesic properties of far infrared will alleviate pain due to the crisis.

Official Title
-----------------
Phase 1 Study to Examine the Use of Far Infrared Radiation for Pain Management During Sickle Cell Crisis

Conditions
-----------------
Anemia, Sickle Cell

Intervention / Treatment
-----------------
* Radiation: Far Infrared Radiation (5μm to 20μm wavelength)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: People with sickle cell disease Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Far Infrared Radiation | Radiation: Far Infrared Radiation (5μm to 20μm wavelength)<br>* Far infrared radiation for 30 to 40 minutes during each session.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Management |  | 40 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HEMOGLOBIN SC DISEASE, HEMOGLOBIN C DISEASE, SICKLE CELL TRAIT, THALASSEMIA
Safety Study for NST-001 and the Neuroject Injection Set to Treat Tinnitus

Study Overview
=================
Brief Summary
-----------------
This research study involves an experimental drug (NST_001) and a delivery system. The main purpose of this research study is to investigate the safety of NST-001, delivered directly to the inner ear for the treatment of tinnitus.

Official Title
-----------------
Safety and Feasibility Study of NST - 001 in Inner Ear Using Neuroject Injection Set for the Treatment of Tinnitus

Conditions
-----------------
Tinnitus

Intervention / Treatment
-----------------
* Drug: NST-001


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients able to provide voluntary consent. Severe tinnitus in one ear that began no more than ten years ago. Ear to be treated must be deaf or have profound hearing loss. Subjects with cardiac disease or hypertension, must have stable disease for at least 6 months. Subject must have intact cochlear nerve on the ear to be treated. Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods as recommended by the study physician. Exclusion Criteria: Current diagnosis of bilateral tinnitus. Current diagnosis or history of pancreatitis. Females that are pregnant or lactating. Use of investigational drugs within the previous 30 days. History of drug dependency or other substance abuse.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 0<br> | Drug: NST-001<br>* Comparison of different dosages of drug.<br>|
| Experimental: Cohort 1<br> | Drug: NST-001<br>* Comparison of different dosages of drug.<br>|
| Experimental: Cohort 2<br> | Drug: NST-001<br>* Comparison of different dosages of drug.<br>|
| Experimental: Cohort 3<br> | Drug: NST-001<br>* Comparison of different dosages of drug.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects will be followed for identification and frequency of drug or procedure-related adverse events. |  | At each follow-up visit. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observe any effect on tinnitus as determined by the visual analog scale, subject tinnitus diary, and investigator interview. |  | At each follow-up visit. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tinnitus, acouphenes, ear, ringing, buzzing, roaring, hissing, clicking
Real-world Comparative Effectiveness of Rivaroxaban Versus VKA

Study Overview
=================
Brief Summary
-----------------
To obtain a better understanding on the comparative effectiveness of rivaroxaban versus VKA(Vitamin K antagonist) for stroke prevention in patients with NVAF(non-valvular atrial fibrillation) in a real-life setting

Official Title
-----------------
Real-world Comparative Effectiveness of Rivaroxaban Versus VKA

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Rivaroxaban (Xarelto, BAY59-7939)
* Drug: VKA (Vitamin K antagonist)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NVAF(non-valvular atrial fibrillation) will be defined as the occurrence of 2 or more inpatient or outpatient claims with ICD(International Classification of Disease)-9 427.31 as the diagnosis code at any time in the patient's data history prior to inclusion Patients will be required to have 180 days of enrollment for the assessment of baseline characteristics CHA2DS2-Vasc score ≥2 during the 180 days prior to index rivaroxaban use baseline period (CHA2DS2-Vasc: Diabetes mellitus; S2: prior Stroke or TIA or Thromboembolism; V: Vascular disease; A: Age 65-74 years; Sc: Sex category) Exclusion Criteria: Patients <18 years of age Patients with valvular AF (Atrial fibrillation) Pregnancy Malignant cancers Transient cause of AF Patients with venous thromboembolism (pulmonary embolism or deep vein thrombosis) Patients with major surgery defined as hip or knee replacement Prescriptions of oral anticoagulants (OACs) (apixaban, warfarin, dabigatran, rivaroxaban) before index date Prescription of more than one OAC on the index date Patient with any of the events defined in the composite endpoint Fatal bleeding Fatal Stroke/Myocardial infarction Intracranial hemorrhage Ischemic stroke Myocardial infarction

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 |
| --- | --- |
| Rivaroxaban<br>NVAF patients who were initiated on rivaroxaban for stroke prevention | Drug: Rivaroxaban (Xarelto, BAY59-7939)<br>* As prescribed by treating physicians<br>|
| VKA (Vitamin K antagonist)<br>NVAF patients who were initiated on VKA for stroke prevention | Drug: VKA (Vitamin K antagonist)<br>* As prescribed by treating physicians<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Hospitalization Events (composite endpoint) |  | Within 2 years of starting treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-valvular atrial fibrillation (NVAF), Prevention, Stroke