linjc16/ctgov huggingface dataset:
An Observational Study on the Prevalence of Chronic Hepatitis D in Romania and the Efficacy of Treatment With Pegasys (Peginterferon Alfa-2a)

Study Overview
=================
Brief Summary
-----------------
This prospective, multicenter, observational study will assess the prevalence of chronic hepatitis D in patients with chronic hepatitis B in Romania and evaluate the efficacy of Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis D. Eligible patients treated with Pegasys according to current medical practice will be followed until 24 weeks after the end of treatment.

Official Title
-----------------
National, Multicenter, Observational Study Evaluating Prevalence, Virological and Clinical Characteristics of Chronic Hepatitis Delta in Romania and Assess Efficacy of Peg-interferon Alfa-2a Treatment in Patients With Chronic Hepatitis D (CHD)

Conditions
-----------------
Hepatitis D, Chronic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For epidemiological part of the study: Adult patients >/= 18 years of age Positive HBsAg for at least 6 months For the non-interventional section of the study Adult patients, >/= 18 years of age Positive HBsAg for at least 6 months Positive anti-delta and positive HDV RNA by PCR Elevated serum ALT >/= 2x ULN Exclusion Criteria: Patients with any of the following will not be eligible for treatment with Pegasys: History of neurological disease History of severe psychiatric disease Decompensated diabetes History of immunologically mediated disease History of severe cardiac disease History or other evidence of severe chronic pulmonary disease Inadequate hematologic function

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of chronic hepatitis B patients in Romania with chronic hepatitis D infection |  | approximately 3.5 years | 
| Response rate: Proportion of patients achieving ALT normalization and HDV RNA negativity 24 weeks after the end of treatment |  | approximately 3.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Virological characteristics (HBeAg/anti-HBe/HBV DNA/anti-HDV Ab/HDV RNA) of patients with chronic hepatitis D |  | approximately 3.5 years | 
| Proportion of chronic hepatitis D patients with liver cirrhosis |  | approximately 3.5 years |
Study on Exercise Safety of Patients With Cardiovascular Diseases

Study Overview
=================
Brief Summary
-----------------
To retrospectively observe the cardiovascular safety during exercise in patients with cardiovascular diseases

Official Title
-----------------
Study on Exercise Safety of Patients With Cardiovascular Diseases

Conditions
-----------------
Cardiovascular Diseases

Intervention / Treatment
-----------------
* Other: exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with confirmed or suspected cardiovascular disease who completed the trial Exclusion Criteria: Refusing to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: exercise|exercise testing|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| exercise-related cardiovascular events |  | 3 months |
Long-term Safety of Lumacaftor/Ivacaftor in Subjects With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation

Study Overview
=================
Brief Summary
-----------------
This is a Phase 3, multicenter, open-label and roll-over study in subjects who are 12 to <24 months of age at initiation of Lumacaftor/Ivacaftor (LUM/IVA) treatment.

Official Title
-----------------
A Phase 3, Open-label, and Rollover Study to Evaluate the Long-term Safety and Tolerability of Lumacaftor/Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: LUM/IVA


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Subjects From Study VX16-809-122 Part B (Study 122) Completed the 24-week Treatment Period and the Safety Follow-up Visit in Study 122B Subjects Not From Study 122 Subjects will be 1 to less than 2 years of age Homozygous for the F508del mutation (F/F) Key Exclusion Criteria: Any clinically significant laboratory abnormalities that would interfere with the study assessments or pose an undue risk for the subject Solid organ or hematological transplantation Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 12 Months

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: LUM/IVA<br>Subjects will receive LUM/IVA for 96 weeks. | Drug: LUM/IVA<br>* LUM/IVA granules for oral administration<br>* Other names: VX-809/VX-770;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability as assessed by the number of adverse events (AEs) and serious adverse events (SAEs) |  | Up to 120 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in sweat chloride |  | From Baseline at Week 96 |
Therapeutic Massage for Generalized Anxiety Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the relative effectiveness of three relaxation treatments (therapeutic massage, thermotherapy, and time in a relaxing environment) in reducing anxiety in persons with Generalized Anxiety Disorder.

Detailed Description
-----------------
Anxiety and stress are costly problems that afflict millions of American adults. Together, they are among the most common reasons for which adults use complementary and alternative medical (CAM) therapies as well as more conventional relaxation therapies. Although massage is one of the most popular CAM treatments for anxiety, its effectiveness for this problem has never been rigorously evaluated. This study is designed to evaluate the effectiveness of massage as a treatment for a diagnosed anxiety disorder. Massage will be compared with two other relaxing treatments: thermotherapy and time in a relaxing environment, which reflect the types of activities that persons with anxiety might try to relieve their symptoms.

Official Title
-----------------
Therapeutic Massage for Generalized Anxiety Disorder

Conditions
-----------------
Generalized Anxiety Disorder

Intervention / Treatment
-----------------
* Behavioral: massage
* Behavioral: thermotherapy
* Behavioral: relaxing environment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Member of Group Health, Seattle metropolitan area Generalized Anxiety Disorder confirmed by SCID At least moderate anxiety Exclusion Criteria: Serious mental health co-morbidity Any life threatening condition Currently receiving psychotherapy Substantial alcohol use Contraindications for massage

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Therapeutic massage | Behavioral: massage<br>* therapeutic massage<br>|
| Active Comparator: 2<br>Thermotherapy | Behavioral: thermotherapy<br>* heat therapy<br>|
| Placebo Comparator: 3<br>Relaxation | Behavioral: relaxing environment<br>* time in a relaxing environment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anxiety |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| worry, depression, disability |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
massage therapy, relaxation treatments
Mold Sensitization Associated Severe Asthma Exacerbation

Study Overview
=================
Brief Summary
-----------------
Mold sensitization is associated with severe asthma exacerbation.

Detailed Description
-----------------
Mold sensitization has been reported to be one of the factors that is associated with severe asthma exacerbation (SAE). The objective is to identify the factors that are associated with SAE in asthmatic children particularly mold sensitization.

Official Title
-----------------
Is Mold Sensitization Associated With Severe Asthma Exacerbation in Children?

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Other: Skin test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asthmatic children aged 1-15 years old from Pediatric Allergy and Immunology division with hospitalized due to severe asthma exacerbation in a preceding year and without severe asthma exacerbation in a preceding year Exclusion Criteria: Other serious systemic diseases, pregnant, lactation

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 15 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 |
| --- | --- |
| Skin test in severe asthma exacerbation<br>Skin test in asthmatic children hospitalized due to severe asthma exacerbation in a preceding year | Other: Skin test<br>* Demographic data review, Disease severity evaluation, Treatment evaluation and Skin prick test for 16 common aeroallergens<br>|
| skin test in outpatient<br>Skin test in asthmatic children without severe asthma exacerbation in a preceding year | Other: Skin test<br>* Demographic data review, Disease severity evaluation, Treatment evaluation and Skin prick test for 16 common aeroallergens<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between mold sensitization and severe asthma exacerbation | Compare mean wheal diameter (mm.) of skin prick test of mold allergen extracts between the group with severe asthma exacerbation and the group without severe asthma exacerbation | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
severe asthma exacerbation, Mold sensitization
Antibiotic Therapy of Acute Uncomplicated Colonic Diverticulitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate if antibiotic therapy is necessary for treatment of uncomplicated colonic diverticulitis. The hypothesis is that Patients with acute uncomplicated colonic diverticulitis will recover the condition without antibiotic therapy and the lack of antibiotic therapy will not lead to complications. The patients will be randomized to conservative treatment with and without antibiotic therapy.

Official Title
-----------------
Is Antibiotic Therapy Mandatory for Treatment of Uncomplicated Acute Colonic Diverticulitis: a Randomized Clinical Trial

Conditions
-----------------
Colonic Diverticulitis

Intervention / Treatment
-----------------
* Drug: Antibiotic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults with CT sign of acute colonic uncomplicated diverticulitis elevated CRP and LPK Temp.38c or more Exclusion Criteria: patients with peritonitis, sepsis or CT- sign of complicated diverticulitis with abscesses or free abdominal air pregnancy immunological incompetence and immunosuppressive therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Antibiotic<br> | Drug: Antibiotic<br>* Antibiotic according to local treatment routine against bowel pathogenesis<br>|
| No Intervention: No antibiotic<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| discharge without complications +/- antibiotic therapy |  | Within 30 days after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate length of hospital stay, cost and late complications |  | one year after admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colonic diverticulitis, diverticular disease, antibiotic therapy
A Novel Multiplex ELISA Assay for Evaluating Patients With Microscopic Hematuria for Bladder Cancer

Study Overview
=================
Brief Summary
-----------------
To improve upon the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with microscopic hematuria.

Detailed Description
-----------------
Hematuria is the most common presentation of BCa with 8% of patients with microscopic hematuria harboring BCa. VUC is the most widely used urine-based assay for detecting BCa; however, it fails to detect approximately 50% of low-grade or early stage BCa when it is most curable. Because of this severe limitation, patients with hematuria will undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder. We propose to improve the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with microscopic hematuria.

Official Title
-----------------
A Novel Multiplex ELISA Assay for Evaluating Patients With Microscopic Hematuria for Bladder Cancer

Conditions
-----------------
Bladder Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older Have documented or reported microscopic hematuria within 3 month of study enrollment Willing and able to give written informed consent Exclusion Criteria (participants must not): Have history of BCa History of previous cancer (excluding basal and squamous cell skin cancer) Have a known active urinary tract infection or urinary retention Have active stone disease (renal or bladder) or renal insufficiency (creatinine >2.0 mg/dL) Have ureteral stents, nephrostomy tubes or bowel interposition Have recent genitourinary instrumentation (within 10 days prior to signing consent) Be unable or unwilling to complete the hematuria evaluation (i.e., cystoscopy and upper tract imaging)

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of multiplex ELISA assay will be confirmed by cystoscopy. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of multiplex ELISA assay will be compared to VUC and NMP-22 BladderChek. |  | 1 year |
Patient Education in Gastroesophageal Reflux Disease

Study Overview
=================
Brief Summary
-----------------
Patients with gastroesophageal reflux disease (heart-burn, acid regurgitation)may benefit from an educational program explaining the medical aspects of the disease, self-management strategies and how to deal with health services. We hypothesized that patients having participated in an educational program would experience an improved quality of life when compared to patients who did not take part (controls).

Official Title
-----------------
Patient Education in Gastroesophageal Reflux Disease

Conditions
-----------------
Gastroesophageal Reflux Disease

Intervention / Treatment
-----------------
* Behavioral: Patient education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: heartburn and acid regurgitation the dominant symptom needing relief at least 5 days/ week when symptoms were at their worst disease history at least 3 months ability to give informed consent Exclusion Criteria: current or previous esophagitis stage 2(Savary-Miller) or greater or peptic ulc continuous need of proton pump inhibitors or NSAIDs wish for surgical treatment earlier surgical treatment in the GI-tract pregnancy alcohol or drug abuse

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Behavioral: Patient education<br>* An educational program: Three lessons spaced over 2 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GERD, Dyspepsia, Education, Information
Validation of a Quality of Life Metric Prolac-10

Study Overview
=================
Brief Summary
-----------------
This is a short-term validation study of a quality of life metric Prolac-10 for patients diagnosed with a prolactinoma, undergoing new medical therapy.

Detailed Description
-----------------
This is a single-site validation study of a novel quality of life study for patients undergoing medical therapy for prolactinoma. Patients will be consented before starting their medical regimen and complete the Prolac-10 questionnaire for baseline and will continued to be followed for 13-weeks into their medical care. The primary goal of this study is to validate the novel quality of life questionnaire in terms of sensitivity, repeatability, and consistency. Secondarily, we aim to validate the test-retest characteristics to further validate sensitivity, repeatability, and consistency. The Prolac-10 metric is Copyright © 2019. The Ohio State University. Modification/derivative rights reserved, all other rights available.

Official Title
-----------------
Validation of a Novel Patient-Reported Quality of Life Metric Prolac-10 for Patients Undergoing Medical Therapy for Prolactinoma

Conditions
-----------------
Prolactinoma, Prolactin-Producing Pituitary Tumor, Pituitary Tumor, Prolactinoma Macroadenoma, Prolactinoma Microadenoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has been diagnosed with prolactinoma by use of appropriate blood tests and brain imaging. 18 years of age or older The subject must in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent Exclusion Criteria: Patient is a prisoner Patient is not English speaking Patient has been previously treated for prolactinoma Patient is pregnant at time of diagnosis and treatment

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 |
| --- | --- | --- |
| Validate the Prolac-10 quality of life metric | In patients diagnosed with a Prolactinoma, validate the novel quality of life questionnaire, Prolac-10 by testing its sensitivity and internal consistency. | 13-weeks post medical therapy start date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validate the test-retest characteristics of the Prolac-10 | Validate the test-retest characteristics of the Prolac-10 to further validate sensitivity, repeatability, and consistency. | 13-weeks post medical therapy start date |