linjc16/ctgov huggingface dataset:
Ranibizumab Treat and Extend in Diabetic Macular Edma

Study Overview
=================
Brief Summary
-----------------
This study is designed to explore a more individualized treatment regime based on achievement of disease stability to define a personal optimal treatment interval with ranibizumab in patients with visual impairment due to diabetic macular edema.

Official Title
-----------------
An Open-label, Prospective, Multicentre, Uncontrolled, Proof of Concept Study Assessing the Efficacy of Lucentis (Ranibizumab) Administered by an Individualized Treat and Extend Dosing Regimen in Patients With Visual Impairment Due to Diabetic Macular Edema

Conditions
-----------------
Diabetic Macular Edema

Intervention / Treatment
-----------------
* Drug: Ranibizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Visual impairment due to focal or diffuse macular edema with center involvement Diabetes type 1 or 2, HbA1c < 12.0% CRT = or > 250 μm Exclusion Criteria: Active inflammation or infection Uncontrolled glaucoma Iris neovascularization, active proliferative retinopathy or vitreomacular traction Prior laser photocoagulation according to defined timelines History of stroke, uncontrolled hypertension Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 18 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: Ranibizumab<br> | Drug: Ranibizumab<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Best Corrected Visual Acuity(BCVA) |  | from month 0 (baseline) to month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in central retinal thickness (CRT) |  | from month 0 to month 12 | 
| the number of injections needed |  | 12 months | 
| the number of patients with improvement in BCVA from baseline |  | 12 months | 
| the number of patients with > 5, 10 and 15 letters improvement from baseline, the latter including patients reaching BCVA >84 |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic macular edema, Macular edema, DME, Diabetic retinopathy, Diabetic eye disease, anti-VEGF, ranibizumab, Lucentis
Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-531 in Healthy Japanese Males

Study Overview
=================
Brief Summary
-----------------
To assess the safety and tolerability of ascending single oral doses of SAM-531, an investigational drug, in healthy Japanese male subjects. Secondary: To obtain preliminary pharmacokinetic (PK) and pharmacodynamic (PD) profiles of SAM-531 in healthy Japanese male subjects.

Official Title
-----------------
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAM-531 Administered Orally to Healthy Japanese Male Subjects

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: SAM-531


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Men aged 20 to 45 years (inclusive) at the time of getting informed consent. Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight ≥50 kg (BMI = [weight (kg)]/[height (m)2). Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and digital 12-lead electrocardiogram (ECG). Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and creatinine levels must be within the upper limit of normal for eligibility. Exclusion criteria Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. Any clinically important deviation from normal limits in physical examination, vital signs, digital 12-lead ECGs, or clinical laboratory test results. Consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) or alcoholic beverages is prohibited from 48 hours and consumption of grapefruit or a grapefruit-containing product is prohibited from 72 hours before study day 1.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SAM-531|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics and pharmacodynamics |  |  |
Honolulu Heart Program-Study of Stroke and Dementia

Study Overview
=================
Brief Summary
-----------------
To clarify the relationship of the arterial lesions to aging, define the influence of the arterial changes on the development of stroke, brain infarction, and dementia, and provide a better understanding of vascular dementia.

Detailed Description
-----------------
BACKGROUND: Morphologic delineation of the arterial lesions will assist the use of experimental models to study molecular mechanisms underlying the lesions and the development of pharmacologic methods for controlling these mechanisms. Further examination of risk factors for the arterial lesions will indicate opportunities for prevention or modifying their evolution. DESIGN NARRATIVE: The study was based on data including risk factors and autopsy brain sections from deceased men from the Honolulu Heart Program. In this cohort, medial and intimal lesions of brain parenchymal arteries were significantly associated with brain infarction and three times more common in men dying of stroke than of non-cardiovascular causes. The specific aims of the study were 1) delineation of the morphologic characteristics of the brain parenchymal artery lesions, their regional anatomic distribution, and their relationship to changes in adjacent brain parenchyma and the degree of atherosclerosis in the major intracranial arteries; 2) characterization of the relationship in men between the arterial lesions and advancing age; 3) characterization in men over 60-65 years of age of the relationship of the arterial lesions to stroke, brain infarction or hemorrhage, and dementia; 4) identification of additional risk factors associated with the arterial lesions. The arterial lesions and adjacent brain parenchyma were examined with conventional histologic stains and immunohistochemical markers for specific cellular and extracellular components of the arterial wall. The prevalence and extent of each type of arterial lesion were determined at three anatomic sites. Baseline risk factors thought to be related to stroke and brain infarction were examined for association with the arterial lesions. Statistical tests of association were based on univariate and multivariate linear and logistic regression models controlled, when necessary, for age. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Cerebrovascular Accident, Cerebrovascular Disorders, Dementia

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Dental Safety Profile of High-Dose Radioiodine Therapy

Study Overview
=================
Brief Summary
-----------------
We aim to assess the incidence of oral and dental adverse events after high-dose radioiodine therapy for differentiated thyroid cancer.

Detailed Description
-----------------
Sialadenitis and xerostomia are the most frequent adverse events of high-dose radioiodine therapy. Saliva has vital functions in maintaining periodontal and oral health. Therefore, xerostomia not only impairs quality of life permanently, but may also increase the risk of caries and tooth extractions. Nevertheless, despite more than 6 decades of radioiodine therapy for thyroid cancer, large studies on long-term oral adverse events are still lacking. In the present study, we investigate the influence of high-dose radioiodine therapy on the long-term oral health.

Official Title
-----------------
The Dental Safety Profile of High-Dose Radioiodine Therapy for Thyroid Cancer

Conditions
-----------------
Thyroid Cancer

Intervention / Treatment
-----------------
* Drug: Radioiodine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically confirmed differentiated thyroid cancer status after total thyroidectomy status after subsequent high-dose radioiodine treatment regular follow-up by a board-certified dentist a minimum follow-up of 1 year after radioiodine therapy. Exclusion Criteria: anaplastic thyroid cancer
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Radioiodine|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
-----------------
Radioiodine, Thyroid Cancer, Sialadenitis, Xerostomia
The Significance of Latissimus Dorsi Flap Innervation in Delayed Breast Reconstruction

Study Overview
=================
Brief Summary
-----------------
Breast reconstruction with a pedicled myocutaneous latissimus dorsi (LD) flap is a widely used reconstruction method. It is controversial if surgical denervation by transecting the thoracodorsal nerve should be performed or not. It is assumed that after denervation the latissimus dorsi muscle will significantly atrophy and lose volume. On the other hand discomforting signs and symptoms from muscle contraction are believed to be prevented if flap is denervated. The aim of the study was prospectively evaluate the influence of LD-flap innervation on the functional and aesthetic outcome of delayed breast reconstruction, and to compare the change in muscle structure in breast MRI and histopathology.

Official Title
-----------------
The Significance of Latissimus Dorsi Flap Innervation in Delayed Breast Reconstruction

Conditions
-----------------
Significance of Latissimus Dorsi Flap Innervation in Delayed Breast Reconstruction

Intervention / Treatment
-----------------
* Procedure: denervation of thoracodorsal nerve or saving the nerve


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: delayed LD-flap breast reconstruction, no recurrent disease observed Exclusion Criteria: recurrent cancer, partial resection of the breast

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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 |
| --- | --- |
| Other: DE-group<br>surgical denervation by excising 1 cm of proximal thoracodorsal nerve | Procedure: denervation of thoracodorsal nerve or saving the nerve<br> <br> |
| Other: IN group<br>thoracodorsal nerve is saved intact | Procedure: denervation of thoracodorsal nerve or saving the nerve<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
-----------------
breast reconstruction, latissimus dorsi flap, thoracodorsal nerve, skeletal muscle disuse, breast MRI
Exercise Intensity for Down Syndrome Children

Study Overview
=================
Brief Summary
-----------------
The current study aimed to determine the appropriate exercise intensity for the rehabilitation of children with down syndrome.

Detailed Description
-----------------
Two groups of down syndrome children were recruited. one group received mild-intensity treadmill training while the other received moderate-intensity treadmill training. Eccentric knee extensors and ankle plantar flexors peak torques were assessed before and after the intervention. Also, functional mobility was assessed for both groups before and after the intervention. The within and between-subjects effect was used to analyze the obtained data before and after the intervention. isokinetic dynamometer and the time up and go test were used for evaluation.

Official Title
-----------------
Effect of Exercise Intensity on Knee and Ankle Joints' Torque and Functional Mobility in Children With Down's Syndrome: a Randomized Controlled Trial

Conditions
-----------------
Down Syndrome

Intervention / Treatment
-----------------
* Other: treadmill exercise (mild)
* Other: treadmill exercise (moderate)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: independent walking Intelligence quotient range from 40 to 70 right dominant foot body mass index from 50 to 75 Exclusion Criteria: chronic diseases congenital anomalies involved in any competitive sport previous injury to the lower limb

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 12 Years

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

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 |
| --- | --- |
| Experimental: mild intensity group<br>Received mild intensity treadmill training according to Martti Karvonen's formula. | Other: treadmill exercise (mild)<br>* mild intensity treadmill training.<br>|
| Experimental: moderate intensity group<br>Received moderate intensity treadmill training according to Martti Karvonen's formula. | Other: treadmill exercise (moderate)<br>* moderate-intensity treadmill training<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| knee extensor peak torque | eccentric normalized peak torque of the knee extensors of the dominant limb. | three months | 
| ankle plantar fexors peak torque | eccentric normalized peak torque of the ankle plantar flexors of the dominant limb. | three months | 
| functional mobility | the assessment of the time up and go test | three months |
Safety and Efficacy Study of Herpes Simplex Virus Type 2 (HSV-2) Therapeutic DNA Vaccine

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to evaluate the safety and efficacy of a therapeutic DNA vaccine in adults with symptomatic herpes simplex virus type 2 (i.e., genital herpes).

Detailed Description
-----------------
To evaluate the safety and efficacy of 4 doses of VCL-HB01, a therapeutic HSV plasmid DNA vaccine formulated with Vaxfectin® in HSV-2-seropositive adults with a reported history of symptomatic genital herpes for at least one year.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Safety and Efficacy of Herpes Simplex Virus, Type 2 (HSV-2) Therapeutic DNA Vaccine in Adults With Symptomatic Genital HSV-2 Infection

Conditions
-----------------
Herpes Genitalis

Intervention / Treatment
-----------------
* Biological: VCL-HB01
* Other: Phosphate-buffered saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HSV-2 seropositive A minimum of 1 year of reported history of genital herpes with recurrences. Exclusion Criteria: History of receiving an investigational HSV vaccine Chronic illness for which a subject's immune system is suspected to be impaired or altered, such as cancer, autoimmune conditions, or diabetes Pregnant or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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 |
| --- | --- |
| Experimental: VCL-HB01, 1-mL dose<br>VCL-HB01, 1-mL dose by intramuscular injection once every 28 days for 4 doses | Biological: VCL-HB01<br>* Investigational Product<br>|
| Placebo Comparator: Phosphate-buffered saline, 1-mL dose<br>PBS, 1-mL dose by intramuscular injection once every 28 days for 4 doses | Other: Phosphate-buffered saline<br>* Placebo<br>* Other names: PBS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion recurrences |  | Up to Day 450 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | Up to Day 450 | 
| Time to first recurrence |  | Up to Day 450 | 
| Proportion of subjects recurrence-free |  | Up to Day 450 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HSV-2, Genital Herpes, Herpes, Herpes Simplex Virus, Type 2
An Study of Patients With Ph- Chromosome-negative Relapsed or Refractory Acute Lymphoblastic Leukemia in the US

Study Overview
=================
Brief Summary
-----------------
A retrospective chart review study of Philadelphia chromosome-negative R/R ALL patients in the US.

Official Title
-----------------
An Observational Study of Patients With Philadelphia Chromosome-negative Relapsed or Refractory Acute Lymphoblastic Leukemia in the US

Conditions
-----------------
Relapsed/Refractory Acute Lymphoblastic Leukemia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria -Medical records of patients initiating treatment for Ph- R/R ALL at participating clinical centers in the US between January 2013 and March 2019 will be eligible for inclusion. Exclusion Criteria Medical records of patients with Ph+ ALL will be excluded. If informed consent is required, medical records of patients who do not provide informed consent will be excluded.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No treatment 1<br>It is planned to have 20-30 sites participating on the trial for chart review of approximately 200-235 patients initiating treatment for Philadelphia chromosome-negative (Ph-) Relapsed or Refractory (R/R) Acute Lymphoblastic Leukemia (ALL) between January 2013 and March 2019. | Other: Other<br>* No intervention other than routine medical care<br>|
| No Treatment 2<br>Initial record abstraction will occur at study site with subsequent reviews occurring at the site every 3 months thereafter until study conclusion on March 2020. | Other: Other<br>* No intervention other than routine medical care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment patterns in patients with Ph- R/R ALL |  | 86 months | 
| Drug utilization in patients with Ph- R/R ALL |  | 86 months | 
| Healthcare resource utilization in patients with Ph- R/R ALL |  | 86 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Receipt of allogeneic stem cell transplantation following salvage treatment |  | 86 Months | 
| Incidence of selected adverse events including cytokine release syndrome, neurologic events, any events resulting in hospitalizations, and other serious adverse events. |  | 86 Months | 
| Best response to salvage treatment (chemotherapy or blinatumomab) within 8 weeks and within 12 weeks of initiation of salvage treatment. |  | 12 Weeks | 
| MRD status within 12 weeks of initiation of salvage treatment |  | 12 Weeks | 
| Overall survival from the time of initiation of salvage treatment |  | 86 Months | 
| RFS from time remission achieved with salvage treatment |  | 86 Months |