linjc16/ctgov huggingface dataset:
Pharmacokinetic, Safety and Tolerability Study of SPARC1028

Study Overview
=================
Brief Summary
-----------------
Evaluation of pharmacokinetic profile of SPARC1028

Detailed Description
-----------------
This is a phase I study of SPARC1028 and recommend phase II dose of SPARC1028 administered once a week for 3 weeks, followed by 1 week of rest.

Conditions
-----------------
Solid Tumor in Advanced Stage

Intervention / Treatment
-----------------
* Drug: SPARC1028


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed diagnosis of solid tumor in advanced stage which taxane-based therapy is a rational treatment option. Age ≥18 years ECOG Performance Status ≤ 1. Estimated life expectancy of at least 12-weeks; Exclusion Criteria: Any malignancy within past 5-years, except non-melanoma skin cancer, cervical intraepithelial neoplasia, or in situ cervical cancer Known hypersensitivity to the study drugs Treatment with any anti-cancer agents within 28 days of study entry Presence of clinically evident active CNS metastases, including leptomeningeal involvement, requiring steroid or radiation therapy

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPARC1028<br> | Drug: SPARC1028<br>* SPARC1028 administration as 30-minute intravenous infusion once a week for 3 weeks, followed by 1 week of rest<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of Maximum Tolerated Dose (MTD) during dose escalation | MTD for SPARC1028 will be determined as dose below the dose at which DLT (Dose Limiting Toxicity) is seen for ≥ 2 subjects | One 21-day treatment cycle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establishing pharmacokinectic profile at each dose level for SPARC1028 | Plasma levels of SPARC1028 will be determined and PK parameters viz., Cmax, AUC0-t, AUC0-∞, MRT, Tmax, t½, Kel, Vd, Cl for SPARC1028 will be evaluated | One 21-day treatment cycle | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Solid, Tumor, Taxane
Short-term Effect of Intensive Insulin Therapy on Incretin Secretion

Study Overview
=================
Brief Summary
-----------------
In type 2 diabetic patients, abnormality in secretion or action of incretin(GLP-1, GIP) is observed. Although controversy still exists, the secretion of GLP-1 is thought to be reduced by 20-30% while GIP secretion is normal or slightly elevated, in type 2 diabetic patients. Various parameters such as the duration of diabetes, the amount of meal and their constitution, gastric bypass surgery, and some antidiabetic drugs affect the secretion of incretin. However, the secretion of GLP-1 and GIP in glucotoxic condition and whether they recover after improvement of glycemic status is not known. The investigators aim to study the effect of intensive insulin treatment in uncontrolled diabetic patients.

Official Title
-----------------
Short-term Effect of Intensive Insulin Therapy on Incretin Secretion

Conditions
-----------------
Type 2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetic patients with disease duration of less than 15years age of 20-70 years BMI 22-27 HbA1c 9-13% patients willing to receive intensive glucose control patients who are able to monitor their glucose level at home for normal glucose tolerance group : NGT subjects with same range of age and BMI for early diabetes group : patients with diabetic duration of less than 5 years and HbA1c level less than 7.5% for at least last 6 months Exclusion Criteria: previous history of insulin treatment patients taking alpha-glucosidase inhibitor or thiazolidinedione serum creatinine >= 1.5 mg/dL hemoglobin < 10 g/dL AST/ALT greater than 3 times normal range ischemic heart disease, congestive heart failure (NYHA grade >=2) chronic renal failure, proliferative diabetic retinopathy, CVA patients with gastroparesis or taking medications altering gastric motility usage of steroid or other agents affecting glucose metabolism pregnant or breast-feeding women

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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 |
| --- | --- |
| wDM<br>Early diabetes | |
| pDM<br>Poorly controlled diabetic patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of incretin secretion before and after intensive insulin therapy |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in incretin secretion according to the duration of diabetes |  | basal | 
| Factors affecting incretin secretion |  | basal | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
incretin, GLP-1, GIP, intensive insulin therapy
Extension Study of MT-1303

Study Overview
=================
Brief Summary
-----------------
To evaluate the long-term safety and tolerability of MT-1303 in subjects with relapsing remitting multiple sclerosis (RRMS).

Official Title
-----------------
A Phase II, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects With Relapsing-remitting Multiple Sclerosis Who Have Completed the MT-1303-E04 Study

Conditions
-----------------
Relapsing-remitting Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: MT-1303-Low
* Drug: MT-1303-Middle
* Drug: MT-1303-High


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completion of the 24-week treatment period in MT-1303-E04 as per protocol Able to provide written informed consent and to comply with the requirements of the protocol For males and females of reproductive potential, two methods of contraception must be used throughout the study and for 12 weeks after cessation of study medication. At least one of the methods of contraception must be a barrier method. Exclusion Criteria: Permanent discontinuation of study medication prior to the end of treatment (EOT) visit in MT-1303-E04 Newly diagnosed diabetes mellitus during MT-1303-E04

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Experimental: MT-1303-Low<br>MT-1303-Low Dose | Drug: MT-1303-Low<br> <br> |
| Experimental: MT-1303-Middle<br>MT-1303-Middle Dose | Drug: MT-1303-Middle<br> <br> |
| Experimental: MT-1303-High<br>MT-1303-High Dose | Drug: MT-1303-High<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessments | Adverse Events | Month 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical efficacy | Annualised relapse rate(ARR) | Month 18 | 
| Magnetic Resonance Imaging (MRI) | Change and percent change in brain volume at EOT | Month 18 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
relapsing-remitting multiple sclerosis, RRMS
Visual Outcomes for Toric Efficacy Study

Study Overview
=================
Brief Summary
-----------------
This is a crossover study of two types of contact lenses (toric orthokeratology and soft multifocals). Primary aims are to quantify correction of astigmatism, subjective and objective visual performance, aberrometry, peripheral refraction and bacterial bioburden between toric orthokeratology and soft toric multifocal contact lenses.

Official Title
-----------------
Visual Outcomes for Toric Efficacy Study

Conditions
-----------------
Astigmatism, Myopia

Intervention / Treatment
-----------------
* Device: Contact lenses (Orthokeratology)
* Device: Contact lenses (Soft Multifocal)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 39 years of age (inclusive) Able to read and understand the study informed consent Plano to -5.00 D (inclusive) vertex corrected sphere power in each eye 1.25 to -3.50 D (inclusive) vertex corrected astigmatism in each eye Best corrected acuity of 20/25 or better in each eye No history of ocular pathology or surgery No significant binocular vision or accommodation abnormality (i.e. strabismus, amblyopia) No gas permeable lens wear for at least 1 month No systemic or ocular contraindications for contact lens wear Not pregnant/lactating (by self-report) Exclusion Criteria: Adults unable to consent Individuals who are not yet adults (infants, children, teenagers) Prisoners Students for whom one of the principal investigators have direct access to/influence on grades would be consented and seen by another investigator for all visits. Pregnant/lactating women (by self-report)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 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: Single Group Assignment
Interventional Model Description: This is a crossover study of two types of contact lenses (toric orthokeratology and soft multifocals).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Orthokeratology Contact lenses<br> | Device: Contact lenses (Orthokeratology)<br>* Contact lenses<br>|
| Experimental: Soft Multifocal Contact lenses<br> | Device: Contact lenses (Soft Multifocal)<br>* Contact lenses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance low contrast visual acuity | Monocular and binocular logMAR visual acuity | Up to two hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual refractive error measured monocularly by cyclopleged auto-refraction | Cycloplegic auto-refraction to measure residual myopia/hyperopia and astigmatism | Up to two hours |
An Algorithm for Intra-operative Goal-directed Haemodynamic Management in Non-cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
A systematic literature search a goal-directed haemodynamic algorithm was created. The hypothesis of this study was that the goal-directed haemodynamic algorithm is feasible and can improve clinical outcome.

Detailed Description
-----------------
After a systematic literature search a goal-directed haemodynamic algorithm was created. The algorithm was adapted to international standards and consensus was reached through a modified Delphi method at international meetings. The feasibility of using the algorithm for intraoperative haemodynamic management was tested and the resultant clinical data analyzed retrospectively for several types of surgery with the hypothesis that the goal-directed haemodynamic algorithm is feasible in the clinical setting and can improve clinical outcome.

Official Title
-----------------
An Algorithm for Intra-operative Goal-directed Haemodynamic Management in Non-cardiac Surgery - a Feasibility Study

Conditions
-----------------
Colonic Tumor, Stage IIIB Ovarian Carcinoma, Fracture of Surgical Neck of Humerus, Neoplasm of Head of Pancreas

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing a surgical repair of hip fractures, open right hemicolectomy and extended hemicolectomy, radical tumor debulking in primary ovarian cancer or a pylorus-preserving pancreatic head resection at the Charité - University Medicine Berlin, Campus Virchow Clinic 18 years and older Exclusion Criteria: emergency procedures

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 |
| --- | --- |
| Conventional care<br>patients treated by conventional haemodynamic care intraoperatively | |
| Haemodynamic algorithm<br>patients treated within a goal-directed haemodynamic algorithm intraoperatively | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospital length of stay | The perioperative hospital length of stay is assessed. | a period of 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| need for ventilator therapy | The perioperative need for ventilator therapy is assessed. | a period of 60 days | 
| monetary reimbursement for prolonged hospital stay | The monetary reimbursement for prolonged hospital stay is assessed to evaluate the impact on financial consequences. | a period of 60 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
haemodynamic, goal-directed therapy, surgery, anaesthesia
The Pharmacology/Aging Clinic

Study Overview
=================
Brief Summary
-----------------
The treatment of HIV and the tests performed for HIV care have changed over the last 20 years. However, improvement of management of HIV-infected subjects is still warranted, especially as the HIV-infected population is aging. Therefore, this study will involve the collection and analysis of clinical information obtained from subjects who are over 50 years of age. For example, patients' risk of heart disease will be measured and monitored by looking at blood tests and clinical data (such as blood pressure). This will allow researchers to understand if the current way of assessing the risk of future heart disease is the best one available for HIV-infected individuals. No genetic research will be done.

Detailed Description
-----------------
Patients will be asked to read the information contained in this leaflet. No extra visits will occur; all samples will be collected at their routine visits to the pharmacology clinic. All blood samples and results will be managed by the routine clinical laboratory at Chelsea and Westminster Hospital, with the exception of the assessment of the hsCRP. The latter is a marker of inflammation that is measured to be able to add more information when cardiovascular risk is assessed. The blood sample for this test is sent to a laboratory in London called The Doctors Laboratory (TDL). All shipped samples are anonymous and patient names will not be disclosed outside the Hospital. The clinical visits will be scheduled approximately once within one year. However, extra visits may be clinically necessary if a clinical condition requires proper follow-up. Furthermore, clinical details will be marked to show patients have agreed to their use for this research study.

Official Title
-----------------
Study Title: The Pharmacology/Aging Clinic: Clinical Routine Monitoring of HIV-infected Patients Over 50 Year of Age.

Conditions
-----------------
HIV Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The ability to understand and sign a written informed consent form HIV-infected patients attending the Pharmacology/Aging Clinic (HIV/GUM Directorate, Chelsea and Westminster Hospital NHS Foundation Trust) Exclusion Criteria: None
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 |
| --- | --- | --- |
Measuring Geographic Atrophy in AMD Patients Using the Nidek MP-3 Microperimetry Device

Study Overview
=================
Brief Summary
-----------------
The investigators would like to know if different imaging devices can improve the quality of images and visualization of imaged tissues. Also, the investigators would like to find out whether these changes are useful in the diagnosis and treatment of eye diseases. Using images of previous participants will allow us to demonstrate the advancement of different technologies, as well be used to allow comparisons between current technologies.

Detailed Description
-----------------
To test the quality of images from the Nidek MP-3 device and to measure Geographic Atrophy (GA) in patients with Age-related Macular Degeneration (AMD).

Official Title
-----------------
Measuring Geographic Atrophy in AMD Patients Using the Nidek MP-3 Microperimetry Device

Conditions
-----------------
Age-related Macular Degeneration (AMD)

Intervention / Treatment
-----------------
* Device: Nidek MP-3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal, healthy participants and patients with AMD Exclusion Criteria: Those suffering from head, neck or other injury which makes them unable to position themselves in head restraint for imaging Participants who are unable to maintain retinal fixation on a specified target Participants unable to achieve sufficient pupil dilation and alignment stability for imaging to take place Patients with media opacity which preclude high quality imaging will be excluded. Exclusion criteria include vulnerable patients; patients under 18, pregnant, economically and educationally disadvantaged, decision impaired, or homeless people. We exclude pregnant women because pregnancy often can alter eye anatomy.
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 |
| --- | --- |
| Control<br>Normal, healthy participants | Device: Nidek MP-3<br>* Nidek MP-3 device to be used to take images which will allow measurement of GA in patients with AMD<br>|
| AMD<br>Age-related Macular Degeneration participants | Device: Nidek MP-3<br>* Nidek MP-3 device to be used to take images which will allow measurement of GA in patients with AMD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geographic Atrophy |  | 1 year |
Improving Wellness for Young Men

Study Overview
=================
Brief Summary
-----------------
This study assesses the impact of a mindfulness-based stress reduction program compared with a health education program for urban middle-school male youth on outcomes of psychological symptoms, coping, stress, sleep, and behavior.

Official Title
-----------------
Improving Wellness for Young Men

Conditions
-----------------
Stress-exposed Urban Male Youth

Intervention / Treatment
-----------------
* Behavioral: Mindfulness-based stress reduction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 7th or 8th graders at St. Ignatius Loyola Academy in 2009-2010 academic year. Parent/guardian consents Student assents Exclusion Criteria (as assessed by school staff): significant psychopathology significant developmental delay significant substance abuse with behavioral consequences significant behavioral problems foster care due to consent restrictions)
Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-based stress reduction<br>The mindfulness-based stress reduction (MBSR) program was previously adapted for urban youth and here further adapted to 12 weekly 50-minute classes for use in school. | Behavioral: Mindfulness-based stress reduction<br> <br> |
| Placebo Comparator: Healthy Topics<br>An age-appropriate health education curriculum was used as a non-specific group comparison for the MBSR program to control for the effects of: positive adult instruction, interactive peer group instruction, learning new material, group size and location, time, and attention. | Behavioral: Mindfulness-based stress reduction<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| psychological symptoms | Psychological symptoms assessed include anxiety, hostility, and depression. | 6 months | 
| coping | Coping assessed includes rumination and typically positive and negative coping approaches. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep | Sleep was measured using diary and actigraphy. | 6 months | 
| stress | Stress was measured using self-report and salivary cortisol. | 6 months |