linjc16/ctgov huggingface dataset:
Biobank and Register of Patients With Agresive Tumors for Translational and Analytical Research

Study Overview
=================
Brief Summary
-----------------
The investigators will collect biosamples of patient blood and tumour tissue for further immunological analysis of blood cell subpopulations, immunosupressive factors concentration, HLA expression an lymphocytes and tumour tissue, and and cancer testis antigenes expression on tumour cells, as well as clinical data on patient's stage, therapy, response and demographics. Possible prognostic and predictive dynamic biomarkers will be discovered for individualisation of treatment strategies

Official Title
-----------------
Analysis of the Immunogenetic Profile of Patients With Aggressive Course of Malignant Neoplastic Process Resistant to the Standard Treatment Approaches: a Translational Study

Conditions
-----------------
Malignant Solid Tumors, Primary Brain Tumor, Melanoma, Soft Tissue Sarcoma, Colorectal Cancer, Kidney Cancer, Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed inform consent Histolgically verified solid tumour Receiving systemic therapy for neoplasm Has archival tumour tissue Provide biosamples with living tumour tissue or blood samples for immunologic assessment Exclusion Criteria: Concurrent Lymphoprolipherative disorder Patients after stem cell or bone marrow thansplantation Incomplete informaton on previous cancer history or medical history Patients with known primary immunodeficiency Patients receiving immunosupressive therapy for concurrent illness Pregnant patients

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Melanoma<br> | |
| Soft tissue sarcoma<br> | |
| Kidney cancer<br> | |
| Primary brain tumors<br> | |
| Malignant neoplasms<br> | |
| Prostate cancer<br> | |
| Colorectal cancer<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression in 3 mo | Presence of disease progression within 3 mo from sample aquisition | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | Time from sample aquisition to death from any reason | Up to 5 years | 
| Progression free survival | Time from sample aquisition to progression or death from the disease | Up to 5 years | 
| Response rate | Response assesmenr with RECIST 1.1 and iRECIST | During the intervention |
Laparoscopic Nissen Versus Toupet Fundoplication: Objective and Subjective Results of a Prospective Randomized Trial

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare subjective and objective outcome and surgical side effects of Nissen and Toupet fundoplication performed in a single institution by only two surgeons and to compare pre and postoperative findings to healthy individuals.

Conditions
-----------------
Gastroesophageal Reflux Disease, Laparoscopic Antireflux Surgery

Intervention / Treatment
-----------------
* Procedure: laparoscopic anti-reflux surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of gastroesophageal reflux disease Long history of GERD symptoms Persistent or recurrent symptoms despite optimal medical treatment Persistent or recurrent complications of GERD Reduced quality of life owing to increasing esophageal exposure to gastric juice Pathological values in the preoperative evaluated functional parameters Exclusion Criteria: Previous esophageal or gastric surgery Poor physical status (American Society of Anesthesiologists (ASA) scores III and IV) Pregnancy

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nissen fundoplication<br> | Procedure: laparoscopic anti-reflux surgery<br> <br> |
| Active Comparator: Toupet fundoplication<br> | Procedure: laparoscopic anti-reflux surgery<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Reverberation Effects on MED-EL Recipients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate speech understanding in simulated reverberant environments with MED-EL cochlear implant recipients.

Detailed Description
-----------------
The study will determine if electrode length and coding strategy effect performance. The investigator will also study performance over time with new recipients.

Official Title
-----------------
The Effects of Reverberation on Speech Understanding in MED-EL Cochlear Implant Recipients

Conditions
-----------------
Hearing Loss, Sensorineural

Intervention / Treatment
-----------------
* Other: Simulated reverberant environment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: MED-EL current cochlear implant recipients of the Flex 24 or 28 will be included Minimum of 6 months experience with their cochlear implant Minimum of 10 new adult Med-El recipients of the Flex 24 or Flex 28 electrodes Patient at the University of Miami Exclusion Criteria: Adults unable to consent Individuals who are not yet adults (infants, children, teenagers)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Current recipient of a Med-El cochlear implant<br>Participants who have received a MED-EL cochlear implant as a standard of care for treatment of hearing loss. Participants are tested at one time point with a simulated reverberant environment. | Other: Simulated reverberant environment<br>* Reverberant environments simulate real-life situations mimicking a living room, classroom and auditorium. Each simulation lasts up to 2 hours.<br>|
| Active Comparator: Future Med-El Recipient<br>Cochlear implant candidates not yet implanted and chose Med-El device as standard of care for treatment of hearing loss. Participants are tested at 3 time points over 6 months in a simulated reverberant environment. | Other: Simulated reverberant environment<br>* Reverberant environments simulate real-life situations mimicking a living room, classroom and auditorium. Each simulation lasts up to 2 hours.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech Performance | Speech performance recorded as percent correct compared to different electrode lengths. | Up to six months | 
| Coding strategy | Speech scores, in percent correct, recorded from simulated reverberant speech tests will be compared between fine structure and envelope coding strategies. | Two hours |
Analysis of Genetic and Environmental Parameters Influencing Growth Rate of Precocious Puberty Children

Study Overview
=================
Brief Summary
-----------------
The goal of CPP-EDG 01 study is to assess possible genetic and/or environmental parameters which may influence the growth rate of children affected by precocious puberty. In this view, we are collecting clinical data and biological samples of children attended as outpatients at the Pediatric Endocrine Center of Pisa from 1998 to present (the study is still open). From biological (blood) samples, gene polymorphisms such as endocrine disruptor levels are determined and compared to different growth pattern of pediatric patients treated with different GnRH agonists.

Official Title
-----------------
Analysis of Genetic and Environmental Parameters Influencing Growth Rate of Precocious Puberty Children

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

Intervention / Treatment
-----------------
* Drug: Triptorelin (GnRH agonists)
* Drug: Leuprolide (GnRH agonists)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinica diagnosis of central precocious puberty Diagnosis is based on growth spurt, bone age advancement, positive GnRH agonist stimulating test, pubertal sex steroid levels before 8 years of age for female and 9 years for male, respectively Exclusion Criteria: Thyroid disorders Peripheric diagnosis of precocious puberty Genetic disorders

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 18 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Triptorelin (GnRH agonists)|nan|
|Drug: Leuprolide (GnRH agonists)|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
-----------------
precocious puberty, genetics, environmental factors
Atherosclerosis Monitoring and Atherogenicity Reduction Study

Study Overview
=================
Brief Summary
-----------------
This study was designed to estimate the effect of two-year treatment with time-released garlic-based drug Allicor on the progression of carotid atherosclerosis in double-blinded placebo-controlled randomized clinical trial.

Conditions
-----------------
Carotid Atherosclerosis

Intervention / Treatment
-----------------
* Dietary Supplement: Allicor
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men aged 40 to 74 years Subclinical carotid atherosclerosis detected by B-mode ultrasound (increased intima-media thickness 1100-2000 mcm) Arterial normotension or mild arterial hypertension (systolic blood pressure <160 mm Hg, diastolic blood pressure <90 mm Hg) Absence of chronic diseases demanding permanent drug administration (more than 2 month per year) Exclusion Criteria: Personal history or diagnostic of following diseases: Transient ischemic attacks Presence of chronic diseases demanding permanent drug administration (more than 2 month per year) Condition of patients moderate to severe Indications for surgical treatment of atherosclerotic lesions localized in the extracranial brachiocephalic system. Individual intolerance of Allicor or appearance of side effects

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 74 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Allicor<br>Allicor 150 mg tablet by mouth two times a day | Dietary Supplement: Allicor<br> <br> * Other names: time-released garlic powder tablets;|
| Placebo Comparator: Sugar pill<br>Placebo tablet 150 mg by mouth two times a day | Drug: Placebo<br>* Sugar pill manufactured to mimic Allicor 150 mg tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| high-resolution B-mode ultrasonography of common carotid arteries | Variation in carotid intima-media thickness (IMT) of the far wall of common carotid arteries | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of serum atherogenicity | Change of the ability of serum to induce cholesterol accumulation in cultured cells | up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allicor, garlic, intima-media thickness, atherosclerosis, regression
Correlation of Intra-abdominal Pressure With Gastric and Urinary Bladder Pressures in Patients With Morbid Obesity

Study Overview
=================
Brief Summary
-----------------
The correlations between gastric and urinary bladder pressures with Intra-abdominal pewssure have not been addressed

Detailed Description
-----------------
Intra-abdominal pressure (IAP) affects cardio-respiratory hemodynamics and can be assessed either directly, or by measuring gastric or urinary bladder pressure. However, in patients with morbid obesity, the correlations between gastric and urinary bladder pressures with IAP have not been addressed. The investigator's aim was to assess the correlations between IAP and gastric and urinary bladder pressure in patients with morbid obesity, at normal and elevated levels of IAP, and to examine the effects of increasing IAP and patient position on hemodynamic and respiratory parameters.

Official Title
-----------------
Correlation of Intra-abdominal Pressure With Gastric and Urinary Bladder Pressures in Patients With Morbid Obesity

Conditions
-----------------
Morbid Obesity, Intra-Abdominal Hypertension, Bariatric Surgery Candidate

Intervention / Treatment
-----------------
* Diagnostic Test: measuring IAP and respiratory parameters


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >18 years Morbid Obesity candidate for bariatric surgery Exclusion Criteria: Contraindication to laparoscopy Advanced COPD Advanced CHF

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: measuring IAP and respiratory parameters|Effect of IAP on respiratory parameters Correlation between IAP and Gastric and urinary bladder pressures|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between intra-abdominal pressure and gastric pressure | different measurement methods | Early post-operative- up to 1 week post operation | 
| Intra-abdominal pressure | Correlation between measured IAP according to different measurement methods | 0-7 days post bariatric surgery |
Burden and Outcome of Shoulder Disorders in Primary Health Care

Study Overview
=================
Brief Summary
-----------------
Consumption of medical care and outcome of shoulder pain and disability in primary care.

Detailed Description
-----------------
Shoulder pain and impairment are common in primary health care. The prognosis of several individuals consulting for a new episode of shoulder problem is surprisingly poor. The objectives are to characterize the consumption of medical care and outcome of shoulder pain and disability in primary health care. A composite questionnaire consisting of demographic information and ASES questionnaire was used to measure the shoulder function. The patients were sent a second questionnaire after one year.

Official Title
-----------------
Burden and Outcome of Shoulder Disorders in Primary Health Care

Conditions
-----------------
Shoulder Pain, Shoulder Mobility Impairment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All individuals suffering from shoulder pain or impairment Exclusion Criteria: No
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 |
| --- | --- | --- |
| Consumption of medical care | Number of consultations, referrals, and radiologic examinations; Use of pain medication; Number of days on sick leave; Number of visits to physiotherapist; Number of surgical procedures | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of the ASES score | ASES score: the patient self-report section of the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Shoulder, Pain, Range of Motion, Disability Evaluation, Function, Sick Leave, Primary Health Care, Visual Analog Scale, Visual Analog Pain Scale, The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form
Impact of an Integrated Intervention on Mental Health in Survivors of Intimate Partner Violence

Study Overview
=================
Brief Summary
-----------------
Intimate partner violence (IPV) against women have negative mental health consequences for survivors; interventions designed to improve survivors' depressive symptoms and health status are limited.Present study evaluate the effectiveness of an integrated intervention in reducing intimate partner violence (IPV) improving health status.

Official Title
-----------------
Randomised Controlled Trial of an Integrated Intervention on Mental Health in Survivors of Intimate Partner Violence

Conditions
-----------------
Domestic Violence

Intervention / Treatment
-----------------
* Behavioral: Intervention Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women over 18 For those who agreed to participate Given written consent Screening for abuse was positive Exclusion Criteria: Screened Negative serious mental condition including suicide, hallucination, Dementia Drug or substance abuse, alcoholism Pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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: Intervention Group<br>The integrated intervention consisted of 12 week of program and group support, based on the freedom program by pet craven. The former component was provided covering beliefs held and tactics used by the domestic violence abusers and took about 45 minutes. It included protection and enhanced choice-making and problem-solving skills. | Behavioral: Intervention Group<br> <br> |
| No Intervention: Wait list control group<br>The group was listed in wait list and were offered the same intervention and support on completion of study period. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression |  | Change from Baseline in Beck Depression Inventory at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Related Quality of Life |  | Change from baseline in SF-36 at 12 weeks |
Duloxetine in the Treatment of Stress Urinary Incontinence.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to monitor the long term safety of duloxetine in the treatment of stress urinary incontinence.

Official Title
-----------------
Long-Term Monitoring of Safety in Subjects Treated With Duloxetine for Stress Urinary Incontinence.

Conditions
-----------------
Urinary Incontinence, Stress

Intervention / Treatment
-----------------
* Drug: Duloxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with predominant stress urinary incontinence. 7 or more incontinence episodes per week. Exclusion Criteria: Use of monoamine inhibitors.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Duloxetine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To generate long-term safety data for duloxetine in the treatment of women with stress urinary incontinence |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To collect data to demonstrate the maintenance of effect of duloxetine as measured by patient Global Impression of Improvement (PGI-I) questionnaire. |  |  |