linjc16/ctgov huggingface dataset:
Osteoporosis Prevention With Low Dose Alendronate

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of the intermittent administration of alendronate in a low dose, 70 mg once every two week, as osteoporosis prevention for menopausal, osteopenic patients, who don't want or can't receive an oestrogenic substitution treatment.

Official Title
-----------------
Prevention of Postmenopausal Bone Loss in Osteopenic Women With Alendronate Given on a 70 mg Once-every Two Week Regimen: a 2-year, Double-blind, Placebo-controlled Clinical Trial.

Conditions
-----------------
Osteopenia

Intervention / Treatment
-----------------
* Drug: alendronate
* Dietary Supplement: Calcium/Vitamin D
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 45 to 60 year-old women Menopausal since at least 6 months Baseline lumbar BMD from -1 till -2.5 Exclusion Criteria: Bone disease other than osteopenia Treatment with selective estrogen receptor modulator (SERMs), calcitonin or hormone replacement therapy within 6 monts prior to randomization Former or current treatment with any bisphosphonate or bone forming agents Chronic use of oral or iv corticosteroids Any diagnosis of malignancy less than 12 months

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Alendronate 70 mg every 2 weeks | Drug: alendronate<br>* alendronate 70 mg every 2 weeks<br>Dietary Supplement: Calcium/Vitamin D<br>* Calcium 500 mg and vitamin D supplementation according to serum level<br>|
| Placebo Comparator: 2<br>Alendronate 70 mg placebo tablet every 2 weeks | Dietary Supplement: Calcium/Vitamin D<br>* Calcium 500 mg and vitamin D supplementation according to serum level<br>Drug: placebo<br>* identical placebo every 2 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of lumbar BMD modification after 2 years |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of hip BMD modification (total hip and sub-regions) |  | 2 years | 
| percentage of modification of bone remodeling markers |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteopenia, osteoporosis prevention, alendronate
Lamellar Transplant With Lyophilized Corneas

Study Overview
=================
Brief Summary
-----------------
- The goals of this study are to develop a lyophilization method for anterior lamellar transplants in Brasil and to make a comparative analysis among patients transplanted with lyophilized and optisol corneas

Detailed Description
-----------------
After the development of a techinique to lyophilize corneas, we randomly assingned 20 patients with keratoconus and visual acuity of < 20/60, who signed the consent term and divided them into 2 groups. One group was transplanted with lyophilized corneas and the other group with optisol corneas. Patients are being followed for 6 months with visual acuity, refraction, topography, orbscan, pachmetry, ultrasound biomicroscopy and confocal microscopy. Results are going to be statistically analysed by SPSS program.

Official Title
-----------------
Randomized Clinical Trial for Lamellar Transplants Using Lyophilized and Optisol Corneas

Conditions
-----------------
Keratoconus

Intervention / Treatment
-----------------
* Procedure: Lamellar transplant with lyophilized corneas


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Keratoconus patient BCVA < 20/60 No systemic diseases Who signed the inform consent Exclusion Criteria: BCVA > 20/60 Presence of deep opacities Systemic diseases

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

| Intervention/Treatment |
| --- |
|Procedure: Lamellar transplant with lyophilized corneas|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Topography |  |  | 
| Orbscan |  |  | 
| Pachmetry |  |  | 
| Ultrasound Biomicroscopy |  |  | 
| Confocal Microscopy |  |  | 
| Masked Examiner to evaluate transparency and quality of the transplant |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lamellar transplant, Lyophilization, Corneas storage, Keratoconus patients, Best corrected visual acuity < 20/60, Signed the consent inform
Risedronate In The Prevention Of Osteoporosis In Osteopenic Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
To confirm the superiority of 5 mg daily risedronate as compared to placebo in maintaining or increasing bone mass in lumbar spine in osteopenic postmenopausal women To confirm the efficacy of 5 mg daily risedronate in osteopenic postmenopausal women in maintaining or increasing bone mass in proximal femur and decreasing bone resorption To confirm general safety of 5 mg daily risedronate as compared to placebo

Official Title
-----------------
A Two-year, Multicenter, Double-blind, Randomized, Placebo-controlled and Parallel Group Study of Oral Risedronate 5 mg Daily in the Prevention of Osteoporosis in Osteopenic Postmenopausal Women (More Than 5 Years Postmenopausal)

Conditions
-----------------
Osteoporosis, Postmenopausal

Intervention / Treatment
-----------------
* Drug: risedronate (HMR4003)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ambulatory, healthy postmenopausal women with Natural menopause and more than 5 years after their last menstrual period or surgical menopause and more than 5 years after surgery osteopenia (lumbar spine T score between 1 and 2.5 SD below the mean value in normal young women). With at least one risk factor for osteoporosis Exclusion Criteria: Women who have received hormone replacement therapy (with estrogen and/or progestogen and/or androgen) or raloxifene within 3 months before visit 2 or calcitonin or calcitriol within 4 weeks before visit 2

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: risedronate (HMR4003)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent changes from baseline in lumbar spine bone mineral density (BMD) at Month 24 measured by DXA. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent changes in proximal femur BMD from baseline at month 12 and 24 (DXA) |  |  | 
| Percent of responders (subjects with a positive change in lumbar spine BMD from baseline)at Month 12 and 24 |  |  | 
| Percent changes in bone turnover markers after 12 and 24 months of treatment |  |  | 
| Physical examination and hematology tests before and after 12 and 24 months of treatment;Serum Chemistry before and after 6, 12 and 24 months of treatment |  |  | 
| Occurrence of adverse events at each visit with special interest for upper gastro-intestinal events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prevention of postmenopausal osteoporosis
Oxidative Stress In Stargardt Disease, Age Related Macular Degeneration and Diabetic Retinopathy

Study Overview
=================
Brief Summary
-----------------
In this study, markers of oxidative stress will be measured in the aqueous humour of stargardt disease, age related macular degeneration and diabetic retinopathy patients compared to controls.

Detailed Description
-----------------
People with Stargardt disease, age related macular degeneration (AMD) and diabetic retinopathy (DR) have decrease in central vision from damage to photoreceptors. One of the mechanisms causing damage is high levels of oxygen in the eye. This damage produces specific biomarkers that can be measured in eye fluid (aqueous humor). In this study, these biomarkers will be assessed in people with Stargardt disease, age related macular degeneration and diabetic retinopathy, compared to controls.

Official Title
-----------------
Oxidative Stress In Stargardt Disease, Age Related Macular Degeneration and Diabetic Retinopathy

Conditions
-----------------
Stargardt Disease, Diabetic Retinopathy, Macular Degeneration (Age Related)

Intervention / Treatment
-----------------
* Other: Anterior Chamber (AC) Tap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent and authorization of use and disclosure of protected health information Age at least 18 years For the study group, patients diagnosed with Stargardt disease, age related macular degeneration and diabetic retinopathy by the investigators, based on clinical phenotype For the control group, patients with no retinal disease undergoing cataract surgery will be eligible. Exclusion Criteria: • None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Stargardt disease, AMD, DR patients<br>Stargardt disease, Age Related Macular Degeneration, Diabetic Retinopathy patients | Other: Anterior Chamber (AC) Tap<br>* Aqueous Samples will be collected for measurement of biomarkers<br>* Other names: AC Tap;|
| Controls<br>Patients without retinal disease who will be undergoing cataract surgery | Other: Anterior Chamber (AC) Tap<br>* Aqueous Samples will be collected for measurement of biomarkers<br>* Other names: AC Tap;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aqueous levels of oxidized adducts on protein (i.e. oxidative biomarker) in patients with stargardt disease, AMD, DR and controls | Baseline = Day of clinic visit for stargardt disease, AMD, DR patients and day of surgery for patients undergoing cataract surgery. No follow up is required. | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DR, AMD
Ankle Athletic Taping Fatigue After a Standard Tennis Warm up

Study Overview
=================
Brief Summary
-----------------
Identify, quantify and compare the fatigue caused in two ankle athletic tapes after the completion of a tennis warm-up.

Conditions
-----------------
Ankle Injuries

Intervention / Treatment
-----------------
* Procedure: Modified ankle athletic taping
* Procedure: Traditional ankle athletic taping


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: There have been no ankle injury in the last 6 months (defined as any problem ankle injury that limited normal activity for more than 48 hours). Not having any neurological, circulatory or degenerative disease or to upset the balance in the lower limbs. Not having had any fractures or have undergone surgery on the lower limbs. No experience pain in the ankle at the time of the study. Exclusion Criteria: Allergy to any of the materials used bandage Suffer an injury before taking the last measurement that prevented them from developing their sport normally.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 25 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Experimental: Traditional ankle athletic taping<br>Described by Purcell and Schuckman (2009) | Procedure: Traditional ankle athletic taping<br> <br> |
| Experimental: modified ankle athletic taping<br>Described by Montag and Asmussen (1992) | Procedure: Modified ankle athletic taping<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Goniometry of the active range of movement |  | participants will be followed for the duration of a standard tennis Warm up, an expected average of 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
athletic tape, tennis, warm-up exercise
Carbohydrate Intolerance Questionnaire Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the validity of using a carbohydrate intolerance questionnaire (CIQ) and/or other health markers as a means of predicting response to insulin sensitivity as determined by an oral glucose tolerance test (OGTT).

Detailed Description
-----------------
This study will utilize a carbohydrate intolerance questionnaire (CIQ). Responses to a CIQ will be correlated with diet inventories, baseline body composition and health assessments, a standard metabolic panel, fasting glucose and insulin levels, a homeostatic insulin resistance model (HOMA), a two hour oral glucose tolerance test (OGTT), and a carbohydrate sensitivity symptom questionnaire administered during the OGTT.

Official Title
-----------------
Validation of Carbohydrate Intolerance Questionnaire

Conditions
-----------------
Carbohydrate Intolerance

Intervention / Treatment
-----------------
* Dietary Supplement: TRUTOL Glucose Tolerance Beverage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant is female Participant is between the ages of 18 and 60 Exclusion Criteria: Participant is pregnant or nursing Participant is diabetic or pre-diabetic Participant has a Body Mass Index (BMI) < 22

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

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

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

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: Glucose Tolerance Beverage<br>75 g. of a fruit punch flavored oral glucose solution | Dietary Supplement: TRUTOL Glucose Tolerance Beverage<br>* A caffeine-free, non-carbonated, glucose tolerance beverage<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete a Carbohydrate Intolerance Questionnaire (CIQ) | Primary Outcome | 1 day | 
| Complete a 2 Hour Oral Glucose Tolerance Test (OGTT) to measure glucose response | Primary Outcome | 2 hours | 
| Complete a 2 Hour Oral Glucose Tolerance Test (OGTT) to measure insulin response | Primary Outcome | 2 hours |
An Observational Modified Prescription-event Monitoring Study of Asenapine (Sycrest)

Study Overview
=================
Brief Summary
-----------------
This post-marketing Modified Prescription-Event Monitoring (M-PEM) safety study of asenapine (SYCREST®) is to be carried out by the Drug Safety Research Unit (DSRU) as part of the Risk Management Plan required by the Committee for Medicinal Products for Human Use (CHMP) to further investigate the safety profile of asenapine in clinical practice. The aim of this study is to proactively capture safety and drug utilisation data in the post-marketing phase of license approval of asenapine as prescribed to patients by general practitioners (GPs) in England. This data is obtained through the completion of questionnaires by GPs.

Official Title
-----------------
An Observational Post-Authorization Modified Prescription-Event Monitoring Safety Study to Monitor the Safety and Utilization of Asenapine (Sycrest) in the Primary Care Setting in England

Conditions
-----------------
Bipolar I Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients prescribed asenapine for any indication by NHS GPs in England. Patients for whom a study questionnaire containing useful information has been returned, will be included in the study cohort regardless of the dose or frequency of administration of asenapine, and irrespective of whether any medicines are concurrently administered. Exclusion Criteria: patient no longer registered with the practice patient for whom no information is provided on study questionnaire patients for whom information provided on study questionnaire relates to another antipsychotic drug patients for whom the index date is an improbable date (i.e. before market launch date) patients for whom the GP reports that the patient did not take or was never prescribed asenapine
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Asenapine<br>Patients prescribed asenapine for any indication by a National Health Service (NHS) general practitioner (GP) in England. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of selected important identified and potential risks | Incidence rates of these risks will be quantified: Somnolence and sedation Weight gain Oral hypoaesthesia Swelling of the tongue and throat Allergic reactions (Type 1 hypersensitivity) | At least 3 months after drug is first prescribed. |
An Observational Study on Epithelioid Sarcoma

Study Overview
=================
Brief Summary
-----------------
Prospective Italian study aimed to provide a description of the population affected by Epithelioid Sarcoma (ES)

Detailed Description
-----------------
The present prospective national study aims to provide a description of the population affected by ES, an insight into the natural history of the disease and an answer some on the outstanding questions on its management. Also, it will focus on enhancing any differences between the two ES variants (classical-type and proximal-type) in order gain a better understanding of the disease, tailor the treatment and lastly improve outcome.

Official Title
-----------------
Epithelioid Sarcoma. An Observational Study

Conditions
-----------------
Epithelioid Sarcoma

Intervention / Treatment
-----------------
* Other: Treatment for Epitheloid Sarcoma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Histological diagnosis of epithelioid sarcoma according to 2014 World Health Organization (WHO) classification, performed on biopsy or surgical specimen Signed informed consent Adequate patient compliance to treatment or follow up No age limit Exclusion criteria Other malignancies within past 5 years, with exception of carcinoma in situ of the cervix and basocellular skin cancers treated with eradicating intent Impossibility to ensure adequate compliance
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Epitheloid Sarcoma patients<br>Patients with diagnosis of localized or advanced epitheloid sarcoma seen in the Italian reference centers for sarcoma treatment that receive treatment for Epitheloid Sarcoma | Other: Treatment for Epitheloid Sarcoma<br>* Treatment Epitheloid Sarcoma according the disease guideline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of treatment given to patients with ES | Number of chemotherapy treatment received patients affected by ES | From diagnosis until the date of death from any cause assessed up to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiotherapy treatments | Number of patients affected by localized ES who received radiotherapy | From the time of diagnosis and then every 6 months up to 60 months | 
| Chemotherapy treatments | Number of patients affected by localized ES who received chemotherapy | From the time of diagnosis and then every 6 months up to 60 months | 
| Predictive biomarkers for response | Tumor biomarkers expression in tumor tissue of patients affected by ES | At time of diagnosis and at the time of any progression where a biopsy is performed up to 60 months |