linjc16/ctgov huggingface dataset:
Biofeedback Treatment for Functional Constipation

Study Overview
=================
Brief Summary
-----------------
The purpose of this randomized, controlled trial is to examine how well biofeedback treatment works to improve constipation. The study is comparing two kinds of biofeedback treatment: 1) anorectal-specific biofeedback therapy and 2) generalized biofeedback therapy using relaxation techniques. The study will also examine which medical and psychological factors determine biofeedback success for treating constipation, such as bowel habits, emotional reactions to constipation, and levels of stress and psychological distress.

Detailed Description
-----------------
This is a randomized controlled trial (RCT) to evaluate the efficacy of anorectal biofeedback therapy for functional constipation secondary to pelvic floor dyssynergia. Participants will be randomized to either six sessions of anorectal biofeedback or to six sessions of generalized biofeedback. Participants will complete questionnaires at baseline, at completion of randomized treatment(12 weeks), and six months after completion of treatment to measure change in bowel habits, constipation severity, constipation-related quality of life, and constipation-related disability. An examination of psychosocial factors will also be conducted prior to treatment to distinguish which ones are predictive of biofeedback success for functional constipation.

Official Title
-----------------
Biofeedback for Functional Constipation: Efficacy and Predictive Factors of Success

Conditions
-----------------
Constipation

Intervention / Treatment
-----------------
* Behavioral: Biofeedback


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic constipation medical recommendation to undergo biofeedback training
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: Biofeedback|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
-----------------
biofeedback, constipation
Pegylated Interferon and Ribavirin in Hepatitis C Virus Infection After Liver Transplantation.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate the efficacy (and safety) of antiviral therapy in patients with chronic hepatitis C after liver transplantation. The only approved drugs for treatment of hepatitis C are pegylated interferon and ribavirin.

Detailed Description
-----------------
Hepatitis C recurrence after liver transplantation remains the main cause of graft loss after liver transplantation. Several strategies can be used to prevent or treat hepatitis C in the setting of liver transplantation. There are no controlled studies evaluating the efficacy and safety of antiviral treatment (using pegylated interferon and ribavirin) in liver transplant recipients. The main endpoint of this study was: 1) histological outcomes (effect of antiviral treatment on disease progression, i.e. liver fibrosis). The secondary endpoint were 1) Sustained virological response (persistent HCV-RNA clearance) and 2) Safety of pegylated interferon and ribavirin

Official Title
-----------------
Randomized Study on the Efficacy and Safety of Pegylated Interferon and Ribavirin in Hepatitis C Virus Infection After Liver Transplantation

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Drug: Pegylated interferon and ribavirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic hepatitis C defined by liver biopsy and presence of HCV-RNA More than 6 months from liver transplantation Written inform consent Exclusion Criteria: Severe hepatitis C recurrence (F3-F4 fibrosis stage, cholestatic hepatitis) Double liver-kidney transplantation Leucopenia (2000) or thrombocytopenia (40.000) Anemia (Hemoglobin lower than 10 g/dL) Renal failure (creatinine > 2 mg/dL) Autoimmune disease All contraindications for interferon and ribavirin therapy

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pegylated interferon and ribavirin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological improvement (decrease in at least one fibrosis stage in follow-up liver biop |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained virological response (persistent HCV-RNA negativation) |  |  | 
| Safety of antiviral therapy |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liver fibrosis, portal pressure, antiviral therapy
The Clinical Trial to Evaluate the Efficacy and Safety of Luphere Depot Inj. 3.75mg(Leuprolide Acetate 3.75mg) in Patients With Precocious Puberty

Study Overview
=================
Brief Summary
-----------------
The purpose of this Clinical Trial was to Evaluate the Efficacy and Safety of Luphere Depot Inj. 3.75mg(Leuprolide acetate 3.75mg) in patients with precocious puberty.

Official Title
-----------------
The Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of Luphere Depot Inj. 3.75mg(Leuprolide Acetate 3.75mg) in Patients With Precocious Puberty; A Single, Open, Multi-center, Prospective Study

Conditions
-----------------
Central Precocious Puberty

Intervention / Treatment
-----------------
* Drug: Luphere depot 3.75mg(Leuprolide acetate 3.75mg)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 4 8 years & tanner stage ≥ 2 Exclusion Criteria: Previous treatment with GnRH analog therapy

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 9 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Luphere<br> | Drug: Luphere depot 3.75mg(Leuprolide acetate 3.75mg)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| At 24 weeks, percentage of subjects with suppression of peak-stimulated Luteinizing Hormone (LH) concentrations |  | At 24 weeks |
Human Papillomavirus Infection and Knowledge and Attitudes About HPV Vaccines Among Men Who Have Sex With Men (MSM)

Study Overview
=================
Brief Summary
-----------------
This is a observational study aims to assess anal and genital human papillomavirus (HPV) infection status among men who have sex with men (MSM) in China, and their knowledge and attitude about HPV vaccine.

Conditions
-----------------
HPV Infection, HIV Infection, Syphilis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years old; Ever had homosexual behaviors in the past 12 months; Willing to take tests for HIV/HPV infection; Physically able and willing to provide written informed consent.

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

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

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

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
-----------------
HPV, MSM, Vaccine, China
Safety and Efficacy Study of DE-110 Ophthalmic Suspension for the Treatment of Dry Eye Disease

Study Overview
=================
Brief Summary
-----------------
Investigate the Safety and Efficacy of Two Concentrations of DE-110 Compared to Placebo for the Treatment of Dry Eye Disease

Official Title
-----------------
A Phase II, Prospective, Randomized, Observer-masked, Parallel-group, Multi-center Study Assessing the Safety and Efficacy of Two Concentrations Compared to Placebo for the Treatment of Dry Eye Disease

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Drug: DE-110 ophthalmic suspension high dose
* Drug: DE-110 ophthalmic suspension low dose
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of dry eye Not wear contact lenses during study 18 years or older Understand and provide written consent Negative pregnancy test and use acceptable method of contraception Exclusion Criteria: Use of any topical ocular medication Any type of ocular surgery Diagnosis of on-going ocular infection and/or allergic conjunctivitis Uncontrolled systemic conditions/lid abnormalities Corneal transplants Females who are pregnant, nursing or planning a pregnancy Participation in another drug trial concurrently or within 30 days prior to study

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DE-110 ophthalmic suspension high dose<br> | Drug: DE-110 ophthalmic suspension high dose<br>* ophthalmic suspension; high dose; QID<br>|
| Experimental: DE-110 ophthalmic suspension low dose<br> | Drug: DE-110 ophthalmic suspension low dose<br>* ophthalmic suspension; low dose; QID<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* DE-110 ophthalmic suspension vehicle;QID<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of DE-110 |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual Response Rate |  | 12 weeks | 
| Individual Efficacy |  | 12 weeks | 
| Individual Symptoms |  | 12 weeks |
Auto-evaluation of Dyspnea

Study Overview
=================
Brief Summary
-----------------
The primary aim of this study was to compare patients-rated evaluation and caregiver's assessment of dyspnea with the standard tools in pulmonology unit (Borg scale and visual analog scale) and the secondary aim was to performed an analysis depending on the diseases (lung cancer vs. other lung diseases) and to verify the agreement between the evaluation between both visual analog scale and modified Borg scale.

Official Title
-----------------
Dyspnea Evaluated by a Qualified Examiner in Patients With Lung Diseases

Conditions
-----------------
Lung Diseases

Intervention / Treatment
-----------------
* Other: dyspnea


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥18 and to have a diagnosis of acute or chronic respiratory disease Exclusion Criteria: mental or cognitive disorders inability to understand the local language

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| lung cancer<br> | Other: dyspnea<br>* dyspnea assessment<br>* Other names: evaluation;|
| other lung diseases<br> | Other: dyspnea<br>* dyspnea assessment<br>* Other names: evaluation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analog scale |  | 3 seconds | 
| borg scale |  | 3 seconds |
Opinion of Brazilian Gynecologists on Hormone Therapy for Menopause and Prescriptive Habits

Study Overview
=================
Brief Summary
-----------------
To evaluate Brazilian gynecologists, through structured online questionnaires, with questions directed to their opinions and prescriptive habits about menopause hormone therapy. Research participants will complete the questionnaires in digital format online.

Detailed Description
-----------------
There are few Brazilian population studies on the opinion of Brazilian gynecologists about the hormonal therapy of menopause in climacteric women, their prescriptive habits and their views on the availability of treatments offered, demanding better evaluation and justifying efforts to analyze the perception of professionals in this area in our country. Methods: To assess gynecologists across the country, through structured online questionnaires, with questions aimed at knowing their opinions and prescriptive habits about menopause hormone therapy. Research participants will complete the questionnaires in digital format online. Doctors will be invited to participate by e-mail messages and by social media.

Official Title
-----------------
Opinion of Brazilian Gynecologists on Hormone Therapy for Menopause and Prescriptive

Conditions
-----------------
Menopause, Opinions, Hormone Replacement Therapy

Intervention / Treatment
-----------------
* Other: Applying a questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Brazilian licensed gynecologist doctors Exclusion Criteria: Retired doctors Health professionals other than medicine doctor Medical specialties other than Gynecology Medical employees of the pharmaceutical industry
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 |
| --- | --- |
| Gynecologists<br>Brazilian gynecologists who agreed to participate and answered the questionnaire | Other: Applying a questionnaire<br>* The participants have to answer a questionnaire addressing their opinion on menopausal hormone replacement therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prescription preference | Answer to the questionnaire addressing gynecologists' prescription habit for menopausal women | At Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge of window of opportunity for hormone replacement therapy | This is to see which proportion of gynecologists know the principle of window of opportunity for menopausal hormone replacement therapy | At Day 1 | 
| Knowledge of indications and contraindications of hormone replacement therapy | This is to see which proportion of gynecologists know the indications and contraindicationsv of menopausal hormone replacement therapy | At Day 1 |
Operative Plate Fixation Versus Replacement for Mason Type III Fracture of Radial Head

Study Overview
=================
Brief Summary
-----------------
To compare the effect of Operative Plate Fixation Versus Replacement for Mason Type III Fracture of Radial Head

Detailed Description
-----------------
From April 2015 to October 2016, patients with comminuted radial head fractures diagnosed as Mason type III are retrospectively included in this study, they were treated with either operative plate or radial head replacement. All the patients are regularly followed up in clinic. Then we will compare the union rate and clinical functional outcome(Mayo score) between the 2 groups at 1 year after surgery.

Official Title
-----------------
Operative Plate Fixation Versus Replacement for Mason Type III Fracture of Radial Head

Conditions
-----------------
Radial Head Fracture

Intervention / Treatment
-----------------
* Procedure: plate fixation
* Procedure: replacement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women aged 18 to 65 years of age with Mason Type III radial head fracture are confirmed by radiograph within 1 month post injury Provision of informed consent Exclusion Criteria: Pathological fractures Non-displaced (cortical contact) fractures Open fractures Presence of vascular or nerve injury Fractures more than 1 month post-injury Limited life expectancy due to significant medical co-morbidity Medical contraindication to surgery Inability to comply with rehabilitation or form completion Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, patients not mentally competent to give consent, etc.)

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Plate Fixation<br>The operating surgeon will determine the positioning of the patient for surgery. ORIF of the radial head fracture will be carried out | Procedure: plate fixation<br>* ORIF of the radial head fracture<br>|
| Replacement<br>The operating surgeon will determine the positioning of the patient for surgery. During the surgery, they take out the the comminuted radial head and proceed replacement using artificial. | Procedure: replacement<br>* replacement of the radial head fracture<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Union rate | Union rate of the fracture from X-ray | 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional score | Mayo score of injury elbow | 1 year after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radial head fracture, replacement, plate
Noninvasive Monitoring in Lower Body Negative and Positive Pressure Tests

Study Overview
=================
Brief Summary
-----------------
The goal of these studies is to assess the use of phonocardiograhy to monitor blood volume. We will evaluate phonocardiographic parameters in normal subjects in increasing levels of lower body negative pressure (LBNP) and lower body positive pressure (LBPP).

Official Title
-----------------
Noninvasive Monitoring in Lower Body Negative and Positive Pressure Tests

Conditions
-----------------
Hemorrhage

Intervention / Treatment
-----------------
* Device: Fluid shift


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years old Good health Free of systemic diseases No contraindications to LBNP/LBPP exposure Normal resting systolic blood pressure (SBP, 100-140 mm Hg) and diastolic blood pressure (DBP, 60-90 mm Hg) Exclusion Criteria: Pregnancy Prior history of cardiovascular disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lower Body Negative/Positive Pressure<br> | Device: Fluid shift<br>* We are using lower body negative and positive pressure to create a fluid shift in the body. This study is investigating if there are changes in phonocardiographic parameters related to changes in blood volume caused by this fluid shift<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the phonocardiographic systolic index (PSI) | Measuring changes in phonocardiographic parameters related to changes in blood volume | Baseline, and at each incremental change of 5-10 mmHg up to 40 mm Hg. Total duration per arm is up to 45 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phonocardiogram
Hyaluronic Acid Gel in Prevention of Intrauterine Adhesions After Endometrial Ablation

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate if hyaluronic acid gel prevents intrauterine adhesion formation after endometrial thermal ablation.

Official Title
-----------------
Autocrosslinked Hyaluronic Acid Gel in Prevention of Intrauterine Adhesions After Bipolar Radiofrequency Endometrial Ablation: a Randomised, Controlled and Double Blind Study

Conditions
-----------------
Menorrhagia

Intervention / Treatment
-----------------
* Other: Hyaluronic acid gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: menorrhagia Exclusion Criteria: abnormal uterine cavity, abnormal endometrial biopsy

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 52 Years

Sexes Eligible for Study
-----------------
Female

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

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: Hyaluronic acid gel<br>Hyaluronic acid gel is placed into the uterus after endometrial ablation | Other: Hyaluronic acid gel<br>* Hyaluronic acid gel is placed into the uterus after endometrial ablation --------------------------------------------------------------------------------<br>|
| Placebo Comparator: No hyaluronic acid gel<br>An empty Pipelle device is taken into the uterus after endometrial ablation as an placebo procedure | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevention of intrauterine adhesion formation | The effect of hyaluronic acid gel on the formation of intrauterine adhesions after endometrial thermal ablation is assessed in an outpatient hysteroscopy after 3 months. Classification of intrauterine adhesions has been created for this study specifically. | 3 months |