linjc16/ctgov huggingface dataset:
Vitamin D Administration in the Nursing Home

Study Overview
=================
Brief Summary
-----------------
Administration of vitamin D 50,000 units once monthly will: Maintain serum 25-OH vitamin D above 20 ng/ml Reduce falls Increase calcaneal BMD Reduce bone turnover Be well tolerated: volunteers will not develop hypercalcemia Improve performance on a swallowing quality of life questionnaire

Detailed Description
-----------------
1. Research questions: We propose a prospective double-blind, randomized, placebo-controlled trial of once-monthly vitamin D oral capsules (50,000 units) in nursing-home residents. Subjects from several Wisconsin nursing homes were randomized to receive once-monthly vitamin D oral capsules (50,000 units) or placebo. Blood levels of 25-OH D, parathyroid hormone, serum calcium, and a marker of bone turnover will be measured periodically by standard lab assays. Swallowing quality of life was measured by questionnaire. Appropriate statistical tests (paired T tests, 95% confidence intervals will be calculated with the large sample approximation for binomial variables, other).

Official Title
-----------------
Intermittent Vitamin D Administration in the Nursing Home: Impact on Vitamin D Status, Falls, Bone Turnover and Bone Density

Conditions
-----------------
Vitamin D Deficiency, Osteoporosis

Intervention / Treatment
-----------------
* Drug: Vitamin D
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female Nursing Home Resident in Wisconsin Exclusion Criteria: Renal Failure Hypercalcemia Metastatic Cancer

Ages Eligible for Study
-----------------
Minimum Age: 55 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: placebo<br>* once-monthly placebo capsules<br>* Other names: lactose;|
| Active Comparator: 2<br> | Drug: Vitamin D<br>* once-monthly vitamin D oral capsules (50,000 units)<br>* Other names: ergocalciferol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma 25-hydroxyvitamin D levels |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma calcium |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteoporosis, vitamin D deficiency
Usability and Performance Evaluation of the AutoLap System - a Feasibility Study

Study Overview
=================
Brief Summary
-----------------
The main objectives of this study are to evaluate the ease of use and performance of the AutoLap system compared to human camera holder during general and bariatric laparoscopic surgeries.

Official Title
-----------------
Usability and Performance Evaluation of the AutoLap System - a Feasibility Study

Conditions
-----------------
General Laparoscopic Surgery Candidate, Bariatric Laparoscopic Surgery Candidate

Intervention / Treatment
-----------------
* Device: AutoLap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed and dated Informed Consent Form (ICF). Patients over 18 years who were scheduled for elective laparoscopic Cholecystectomy, Nissen fundoplication, paraesophageal hernia and sleeve surgery procedures Exclusion Criteria: Extensive adhesions that will preclude routine laparoscopic surgical approach. Pregnancy Patient participates in any other clinical study 60 days prior to the start of the study and throughout the study duration.

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: Group 1<br>Procedures will be performed with the AutoLpap system used for holding and controlling the movement of the laparoscope. | Device: AutoLap<br> <br> |
| No Intervention: Group 2<br>Procedures will be performed with the assistance of human camera holder. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image stability | measured by the vibrations of inertial sensors | during surgery, an expected average of 1 hour | 
| Usability | The ease of use of the AutoLap system will be evaluated by a set of questionnaires | post surgery, an expected average of 3 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System set-up time |  | during surgery, an expected average of 5 minutes | 
| Length of surgery |  | during surgery, an expected average of 1 hour | 
| The Number of times that the laparoscope was removed for cleaning |  | during surgery, an expected average of 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laparoscopic Cholecystectomy, laparoscope holder, Nissen fundoplication, paraesophageal hernia, sleeve surgery
The Safety and Effectiveness of Clarithromycin in the Prevention of Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients

Study Overview
=================
Brief Summary
-----------------
To determine whether clarithromycin is safe and effective in preventing disseminated Mycobacterium avium Complex in HIV-infected patients with CD4 counts <= 100 cells/mm3.

Official Title
-----------------
A Prospective, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study of the Safety and Efficacy of Clarithromycin for the Prevention of Disseminated Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients With CD4 Counts <= 100 Cells/mm3

Conditions
-----------------
Mycobacterium Avium-intracellular Infection, HIV Infections

Intervention / Treatment
-----------------
* Drug: Clarithromycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: HIV infection. CD4 count <= 100 cells/mm3. No evidence of MAC. Life expectancy of at least 6 months. Exclusion Criteria Concurrent Medication: Excluded: Certain restricted drugs (details not available). Patients with the following prior conditions are excluded: History of allergy or hypersensitivity to macrolides. Active substance abuse or other conditions that would affect study compliance.

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

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

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

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

Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Clarithromycin|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
-----------------
Mycobacterium avium-intracellular Infection, Acquired Immunodeficiency Syndrome, Clarithromycin
Immunotherapy For Men With Objective Disease Progression On Protocol D9902 Part B (NCT00065442)

Study Overview
=================
Brief Summary
-----------------
This is an open label, Phase 2 trial of APC8015F immunotherapy in men with objective disease progression on protocol D9902 part B (NCT00065442)

Official Title
-----------------
AN OPEN LABEL, SINGLE ARM TRIAL OF IMMUNOTHERAPY WITH AUTOLOGOUS ANTIGEN PRESENTING CELLS LOADED WITH PA2024 (APC8015F) FOR MEN WITH OBJECTIVE DISEASE PROGRESSION ON PROTOCOL D9902 PART B

Conditions
-----------------
Metastatic Androgen Independent Prostate Cancer

Intervention / Treatment
-----------------
* Biological: APC8015F


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Objective disease progression Subjects must have been enrolled in the APC-Placebo arm of D9902B (NCT00065442) Exclusion Criteria: Infection requiring IV antibiotics Treatment with anticancer interventions within 14 days prior to enrollment Any medical condition which could compromise the study's objectives (discretion from sponsor)

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

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

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: APC8015F<br> | Biological: APC8015F<br>* APC8015F is an autologous active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. APC8015F consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), that have been activated in vitro with a recombinant fusion protein.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of APC8015F by Review of Reported Adverse Events | All subjects who received at least one infusion of APC8015F (N = 109) were included in the safety analysis set and were followed for safety. Refer to Serious Adverse Events and Other Adverse Events. | periodically over 24 months |
DEXYCU (Dexamethasone Intraocular Suspension) 9% Retrospective Study 001

Study Overview
=================
Brief Summary
-----------------
Retrospective study to provide clinical outcomes with DEXYCU (dexamethasone intraocular suspension) 9%.

Detailed Description
-----------------
This retrospective study is intended to provide large-scale, real-world data on clinical outcomes with DEXYCU (dexamethasone intraocular suspension) 9%.

Official Title
-----------------
DEXYCU (Dexamethasone Intraocular Suspension) 9% Retrospective Study 001

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Drug: DEXYCU (dexamethasone intraocular suspension) 9%.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Male and Female subjects at least 18 years of age Subjects who underwent cataract surgery from 12Mar2019 to 15Dec2019 and received DEXYCU Exclusion Criteria • Subjects who underwent cataract surgery and did not receive DEXYCU

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 |
| --- | --- |
| DEXYCU (dexamethasone intraocular suspension) 9%.<br>DEXYCU (dexamethasone intraocular suspension) 9%. Single dose, intraocularly in the posterior chamber at the end of surgery. The dose is 0.005 mL of dexamethasone 9% (equivalent to 517 micrograms). | Drug: DEXYCU (dexamethasone intraocular suspension) 9%.<br>* DEXYCU contains dexamethasone 9% w/w (103.4 mg/mL) as a sterile suspension for intraocular ophthalmic administration. DEXYCU is provided as a kit for administration of a single dose of 0.005 mL of 9% dexamethasone (equivalent to 517 micrograms of dexamethasone).<br>* Other names: dexamethasone intraocular suspension;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Eyes With Anterior Chamber Cell Grade 0 | Of eyes with a record at postoperative day 8, percentage with anterior chamber cell grade 0. Cells in the anterior chamber of the eye are indicative of intraocular inflammation and are evaluated using a slit-lamp biomicroscope; a grade of 0 indicates that no inflammatory cells were visible in a 1 mm by 1 mm slit beam. | Postoperative day 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DEXYCU, Cataract, dexamethasone intraocular suspension
Vascular Reactivity in Metabolic Syndrome and Diabetic Patients Using Diffuse Optical Spectroscopy

Study Overview
=================
Brief Summary
-----------------
Metabolic Syndrome is a highly prevalent condition that is comprised of several major clustering factors that increase the risk for developing cardiovascular disease. Diffuse Optical Spectroscopy is a non-invasively measure can show changes in the microvasculature of human. Diffuse Optical Spectroscopy measures the optical absorption and scattering properties of near-infrared light in tissues such as muscle in order to quantify the absolute concentration of oxygenated and deoxygenated hemoglobin, water, and lipids. It provides quantitative and functional information on the microvasculature related to tissue perfusion, metabolic changes, and indicators of tissue damage.

Detailed Description
-----------------
The researchers can use Diffuse Optical Spectroscopy to monitor changes in the microvasculature of patients with Metabolic Syndrome and diabetic mellitus, and patients with Diabetic Peripheral and Autonomic Neuropathy, versus non-diseased and predisposed subjects by evaluating the changes in oxygen metabolism. The Diffuse Optical Spectroscopy measure the changes in the concentration and oxygen saturation of hemoglobin in the microvasculature under stress, for example, during exercise and in response to changes in breathing habits. The sensitivity of Diffuse Optical Spectroscopy to tissue hemodynamics provides an impressive arena of useful clinical applications..

Official Title
-----------------
Diffuse Optical Spectroscopy Measure Microvascular Changes in Metabolic Syndrome and Diabetes Mellitus in Order to Assess Cardiovascular Disease Risk.

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: Diffuse Optical Spectroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult ages of 45 to 75 Have been clinically diagnosed with Type II Diabetes Mellitus Have a diagnosis of Metabolic Syndrome Exclusion Criteria: taking light-sensitive drugs for use in photodynamic therapy pregnant

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 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 |
| --- | --- |
| Diagnostic tool<br>Diffuse Optical Spectroscopy non-invasively measure changes in the microvasculature | Device: Diffuse Optical Spectroscopy<br>* Diffuse Optical Spectroscopy non-invasively measure changes in the microvasculature<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Microvascular | Diffuse Optical Spectroscopy non-invasively measure changes in the microvasculature | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metabolic Syndrome
AZD7268 Single Ascending Dose Study in Healthy Japanese Subjects

Study Overview
=================
Brief Summary
-----------------
This is a Phase I, single center, randomized, double-blind, placebo-controlled single ascending oral dose study to assess the safety, tolerability and pharmacokinetics of AZD7268 in healthy Japanese subjects.

Official Title
-----------------
A Phase I, Single Center, Randomized, Double-Blind, Placebo-Controlled Single Ascending Oral Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7268 in Healthy Japanese Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: AZD7268
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Japanese male and female (of non-child bearing potential) subjects 20 to 45 years of age, inclusive Body weight between 50 and 90 kg, inclusive, with a Body Mass Index (BMI) 18 to ≤ 27 kg/m2 Exclusion Criteria: Clinically relevant disease or disorder (past or present), which in the opinion of the investigator, may either put the subject at risk because of participation in the study or influence the results or the subject's ability to participate in the study Any clinically significant abnormalities in physical examination, vital signs, clinical chemistry, hematology or urinalysis results as judged by the investigator and/or sponsor Smoking in excess of 5 cigarettes per day or equivalent within 30 days of Day 1

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD7268<br> | Drug: AZD7268<br>* Single Oral<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Single Oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To asses the safety nature and incidence of adverse events, blood pressure, pulse rate, body temperature, physical examination, laboratory assessments (clinical chemistry, hematology, and urinalysis parameters), effects on ECG parameters, EEG recordings, |  | From screening period to follow-up, 44 days (maiximum). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the pharmacokinetics of AZD7268 and its metabolite(s) in plasma and urine. |  | Blood and urine sampling from pre-dose until 72 hrs post dose. | 
| To collect and store DNA for future exploratory research |  | One blood sampling after randomisation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase I, Japanese healthy volunteer, AZD7268
A Single Dose Study of KHK6640 in Japanese Patients With Alzheimer's Disease.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of KHK6640, given as a single dose in Japanese patients with Mild to Moderate Alzheimer's Disease.

Official Title
-----------------
A Phase 1 Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of KHK6640 in Japanese Patients With Alzheimer's Disease.

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: KHK6640
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with mild to moderate Alzheimer's Disease Body weight ≥ 40 kg and < 100 kg Clinical Dementia Rating (CDR) score of 1 or 2 Mini Mental State Examination (MMSE) score of ≥ 17 amd ≤ 26 Exclusion Criteria: Previous active treatment with an Alzheimer's Disease immunotherapy in an investigational study Use of another investigational drug within 4 months prior to the enrollment Subjects who meet National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia Subjects with a history of presence of clinically significant seizures, brain trauma, transient ischemic attack, and/or cerebrovascular disease Subjects with a presence of a neurological condition that could be contributing to cognitive impairment above and beyond that caused by the subject's Alzheimer's Disease Subjects who have evidence of infection, tumor, or other clinically significant lesions that could indicate a dementia diagnosis other than Alzheimer's Disease

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 84 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KHK6640<br>KHK6640 | Drug: KHK6640<br>* Single ascending dose administration<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Single ascending dose administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | Up to 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
KHK6640, Phase 1, Japanese, single dose, Alzheimer's disease