linjc16/ctgov huggingface dataset:
STS & ACC Foundation's Transcutaneous Valve Therapy (TVT) Registry Foundation's Transcutaneous Valve Therapy (TVT) Registry

Study Overview
=================
Brief Summary
-----------------
The TVT Registry was designed to support a national surveillance system to assess the characteristics, treatments, and outcomes of patients receiving transcutaneous valve therapies.

Detailed Description
-----------------
The TVT Registry was designed to support a national surveillance system to assess the characteristics, treatments, and outcomes of patients receiving transcutaneous valve therapies. Patient-level data are submitted by participating hospitals to The Society of Thoracic Surgeons (STS) and American College of Cardiology Foundation's (ACCF) joint TVT Registry. The purposes of the TVT Registry include: (i) collecting pertinent and standardized data elements from participating hospitals, health care providers and others that measure and assess the quality of care for patients receiving TVT; (ii) providing confidential periodic reports to participating hospitals, health care providers and others, to evaluate and improve the quality of care in these areas; and (iii) permitting and fostering appropriate research based upon the data collected by means of the TVT Registry. The secondary aim of the TVT Registry is to serve as a scalable data infrastructure forpost market studies.

Official Title
-----------------
The Society of Thoracic Surgeons and American College of Cardiology Foundation's Transcutaneous Valve Therapy (TVT) Registry

Conditions
-----------------
Transcutaneous Valve Therapies

Intervention / Treatment
-----------------
* Device: Transcutaneous Valve Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (age 18 and older) who undergo an attempted transcutaneous aortic or mitral valve therapy procedure, with an FDA approved device. Exclusion Criteria: -

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Transcutaneous Valve Therapy|Any patient who undergoes an attempted transcutaneous aortic or mitral valve therapy procedure, with an FDA approved device.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac and cerebrovascular events | increase in the 30-day risk of adverse events among patients receiving TAVR | 30 days from procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Proportion of patients who are alive with at least moderate functional improvement (defined as at least 10 point improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline) at 1 year after receiving TAVR | 1 year | 
| Major adverse cardiac and cerebrovascular events | increase in the 1 year risk of adverse events among patients receiving TAVR | 1 year from procedure |
Sierra High Definition Ano-Rectal Manometry

Study Overview
=================
Brief Summary
-----------------
Hypotheses: High definition manometry (HDM) is safe and feasible in humans; HDM accurately characterizes anorectal anatomy and function in healthy humans; HDM provides comparable information regarding the structure and function of the anorectal region, to that obtained from ano-rectal manometry and anal ultrasonography (AUS), in patients with fecal incontinence or constipation. Methods: 20 healthy volunteers, 20 patients with fecal incontinence, 20 patients with constipation will be recruited. Because anorectal disorders are more common in women, the investigators will recruit approximately 8 men and 12 women in each group. Each subject will undergo anorectal manometry, anal ultrasound and high definition manometry. Data Analysis: Spearman correlational analysis will be performed to compare the parameters listed above. Also, the diagnostic yield of anal ultrasonography vs HDM in identifying anatomic sphincter defects will be assessed.

Official Title
-----------------
Sierra High Definition Ano-Rectal Manometry

Conditions
-----------------
Constipation, Fecal Incontinence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For patients: Either fecal incontinence (the occurrence of at least one episode of involuntary discharge of stool matter per week) or constipation (Rome III criteria) (16,17) Adults between the ages of 18-80 yrs. For healthy volunteers: Adults between the ages of 18-80 yrs No gastrointestinal symptoms Exclusion Criteria: Rectal prolapse or anal fissure on physical examination Recent pelvic or recto-anal surgery (< 6 months ago) History of pelvic irradiation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| healthy volunteers<br> | |
| patients with fecal incontinence<br> | |
| patients with constipation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the feasibility of HDM in three groups of human subjects; healthy humans, patients with fecal incontinence and patients with chronic constipation |  | One visit |
Examining Self-tracking Behaviors in a Mobile Intervention for Binge Eating and Weight Management

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand users' experiences and interests completing self-tracking in a mobile intervention for binge eating and weight management.

Official Title
-----------------
Examining Self-tracking Behaviors in a Mobile Intervention for Binge Eating and Weight Management

Conditions
-----------------
Obesity, Binge Eating

Intervention / Treatment
-----------------
* Behavioral: Track clinician-determined symptoms
* Behavioral: Track clinician-determined and self-determined symptoms


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults age 18 years or older Obesity (BMI ≥30) Recurrent binge eating (≥12 episodes in the past 3 months) Interested in losing weight and reducing binge eating Willing to use a mobile application Willing to practice self-monitoring Has access to a scale Not pregnant English-speaking Exclusion Criteria: None

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Condition 1<br>Track clinician-determined symptoms | Behavioral: Track clinician-determined symptoms<br>* Participants will track clinician-determined symptoms<br>|
| Experimental: Condition 2<br>Track clinician-determined and self-determined symptoms | Behavioral: Track clinician-determined and self-determined symptoms<br>* Participants will track clinician-determined symptoms and a self-determined symptom<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance | Number of tracking entries completed | 3 weeks | 
| Satisfaction with tracking | Self-reported satisfaction with tracking, based on the Satisfaction subscale of the Usefulness, Satisfaction, and Ease of use (USE) Questionnaire, with higher scores on the 1-7 rating scale indicating greater satisfaction | 3 weeks |
Photodynamic Therapy in Anal Fistula

Study Overview
=================
Brief Summary
-----------------
Objective: Validate and analyze the results of intralesional photodynamic therapy in the treatment of complex anal fistula. Methods: Prospective observational study including patients treated for complex anal fistula who underwent intralesional photodynamic therapy (i-PDT). Patients were included with a minimum follow up of 1-year, in order to evaluate recurrence, continence and postoperative morbidity. Intralesional 5-aminolevulinic acid gel 2% was directly injected into the fistula. The internal and external orifices were closed. After an incubation period of 2 h, the fistula was irradiated using an optical fibre connected to a red laser (MULTIDIODE 630 PDT, INTERmedic, Spain) operating at 1 W/ cm for 3 min (180 Joules).

Official Title
-----------------
Efficacy of Photodynamic Therapy and Intra-lesional 5-wing in Complex Perianal Fistula

Conditions
-----------------
Rectal Fistula

Intervention / Treatment
-----------------
* Procedure: photodynamic therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: complex anal fistula according to Parks classification Exclusion Criteria: Non cryptoglandular fistulas acute sepsis inflammatory bowel diseases simple fistulas (defined as subcutaneous, intersphincteric and low transsphincteric fistula) pregnant patients ASA IV patients <18 immunocompromised patients who refused consent.

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 |
| --- | --- |
| complex anal fistula<br> | Procedure: photodynamic therapy<br>* Intralesional 5-aminolevulinic acid gel 2% was directly injected into the fistula. The internal and external orifices were closed. After an incubation period of 2 h, the fistula was irradiated using an optical fibre connected to a red laser (MULTIDIODE 630 PDT, INTERmedic, Spain) operating at 1 W/ cm for 3 min (180 Joules).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing | Yes/Not | 12 months after surgery |
Ultra-low Dose Subcutaneous IL-2 in Renal Transplantation

Study Overview
=================
Brief Summary
-----------------
To investigate the safety and tolerability of treatment with low dose rIL-2 in renal transplant recipients. To assess the immunologic impact of low dose rIL-2 in renal transplant recipients. To assess the efficacy of low dose rIL-2 in renal transplant recipients.

Official Title
-----------------
Safety and Efficacy of Treatment With Ultra-low Dose Subcutaneous IL-2 to Promote Regulatory T Cells Post Renal Transplantation

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Biological: aldesleukin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Kidney transplant recipients >18 years and <75 years of age >6 months post Tx on stable dose of immunosuppression Transplant biopsy showing interstitial fibrosis and tubular atrophy of grade II or greater, with some evidence of lymphocytic infiltration (biopsy is NOT a study procedure, it would be performed as part of the patient's SOC) Ability to give informed consent Exclusion Criteria: Biopsy proven acute cellular rejection; greater than grade 1A Baseline creatinine >3.5mg/dL Patients with active infection, including Hepatitis B and C, HIV Current or prior invasive malignancy Patients who are pregnant or breastfeeding Patients who are unable to give consent Prior intolerance of/allergy to IL2 Inability to comply with treatment History of thrombotic angiopathy including hemolytic uremic syndrome and thrombotic thrombocytopenic purpura Symptomatic congestive cardiac failure or uncontrolled cardiac angina Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug. WOCBP and male subjects with reproductive potential must agree to use a highly effective method of birth control [defined in protocol & ICF] during study treatment, and for 6 months after completion of treatment.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aldesleukin<br> | Biological: aldesleukin<br> <br> * Other names: proleukin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in Treg Count |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transplantation, interleukin-2, IL-2, Kidney, Renal
Muscle Response to Enzyme Replacement Therapy in Pompe Disease

Study Overview
=================
Brief Summary
-----------------
This study is to study the response of muscle cells from Pompe disease after enzyme replacement therapy

Official Title
-----------------
Muscle Response to Enzyme Replacement Therapy in Pompe Disease

Conditions
-----------------
Pompe Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with Pompe disease, prepare or on enzyme replacement therapy signed informed consent Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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 |
| --- | --- | --- |
| all morphology changes improvement |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pompe disease, muscle, enzyme replacement therapy
Long Term Results of Combined Transpupillary Thermotherapy (TTT) Indocyanine Green (ICG) Based Photodynamic Therapy (PDT) in Choroidal Melanoma

Study Overview
=================
Brief Summary
-----------------
This is a report of 10 years results of combined Transpupillary thermotherapy (TTT) treatment with Indocyanine green (ICG) in controlling small and medium-sized choroidal melanomas.

Detailed Description
-----------------
The study was done in a Clinical practice setting. Forty six eyes of 46 patients with small or medium-sized choroidal melanomas were treated with i-TTT using infrared light delivered from a diode laser. All patients were evaluated to rule out systemic metastasis and underwent a complete ophthalmological evaluation including: Slit lamp biomicroscopy, dilated fundus examination, Fluorescein angiography, Optical coherence tomography and A/B ultrasonography. Main outcome measures were: Changes in visual acuity, complications associated with the treatment and local control of the tumor.

Official Title
-----------------
10 Years Report of Combined Simultaneous Transpupillary Thermotherapy and ICG-based Photodynamic Therapy for Choroidal Melanoma

Conditions
-----------------
Choroidal Melanoma

Intervention / Treatment
-----------------
* Procedure: TTT + ICG-based PDT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Small and medium-sized choroidal melanoma Patients older than 18 years old. Patients who can read and signed the informed consent. Exclusion Criteria: Patients with ocular inflammation. Patients with another active ocular disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- |
| 1<br>Combined treatment of Transpupillary Thermotherapy and ICG-based photodynamic therapy (PDT) | Procedure: TTT + ICG-based PDT<br> <br> |

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
-----------------
Transpupillary thermotherapy, Choroidal melanoma, ICG-Photodynamic therapy
Phase I/II Study of High-Dose Acyclovir for Central Nervous System or Disseminated Neonatal Herpes Simplex Virus Infection

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Evaluate whether high-dose acyclovir decreases acute and long-term morbidity and mortality in neonates with central nervous system or disseminated herpes simplex virus (HSV) infection. II. Evaluate whether high-dose acyclovir is safe and tolerated in the newborn. III. Assess resistance to antiviral medication. IV. Amplify disease classification for the purpose of predicting prognosis. V. Assess any changes in viral excretion patterns. VI. Evaluate whether antigens and antibodies specific for HSV glycoproteins within the cerebrospinal fluid (CSF) predict long-term neurologic outcome. VII. Evaluate whether specific antigens and antibodies in the CSF appear late after treatment and are indicative of insidious reactivation of virus in the brain.

Detailed Description
-----------------
PROTOCOL OUTLINE: Neonates are treated with intravenous acyclovir for 21 days. Patients are followed at day 28, and at 6, 12, 24, 36, and 48 months.

Conditions
-----------------
Herpes Simplex

Intervention / Treatment
-----------------
* Drug: acyclovir


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Herpes simplex virus infection that is disseminated or localized to the central nervous system Virologically confirmed by 1 of the following methods: Tissue culture Monoclonal antibody staining Electron microscopy --Prior/Concurrent Therapy-- No concurrent antiviral therapy --Patient Characteristics-- Life expectancy: No imminent demise Birth weight at least 1200 g Gestational age over 32 weeks

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 28 Days

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: acyclovir|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
-----------------
herpes simplex virus infection, herpesvirus infection, immunologic disorders and infectious disorders, rare disease, viral infection
IOP-Lowering Efficacy of Brinzolamide 1.0% Added to Travoprost 0.004%/Timolol 0.5% Fixed Combination as Adjunctive Therapy

Study Overview
=================
Brief Summary
-----------------
Uncontrolled glaucoma patients being treated with a prostaglandin agent alone or in combination with adjunctive drugs in fixed or unfixed combinations, will be switched from their current therapy to travoprost/timolol fixed combination and either Azopt or placebo

Official Title
-----------------
IOP-Lowering Efficacy of Brinzolamide 1.0% Added to Travoprost 0.004%/Timolol 0.5% Fixed Combination as Adjunctive Therapy

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Drug: Azopt


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Glaucoma Exclusion Criteria: Under 18

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 |
| --- |
|Drug: Azopt|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP lowering |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma