linjc16/ctgov huggingface dataset:
Guidance for Elderly With Cognitive Disorders

Study Overview
=================
Brief Summary
-----------------
The purpose of the programme is to facilitate the anticipation of dementia both in elderly patients suffering from this disease and in their carers and to diminish care burden in order to improve quality of life and daily functioning.

Official Title
-----------------
Guidance Programme for Elderly With Cognitive Disorders

Conditions
-----------------
Mild Dementia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elderly (> 70 years) with mild dementia in presence of a carer.

Ages Eligible for Study
-----------------
Minimum Age: 70 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 |
| --- | --- |
| Elderly with mild dementia<br>>70 years old and presence of a carer | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life and care burden at 0, 3 and 6 months. |  | 0, 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive, behavioural and affective status |  | 0, 3 and 6 months |
GER-009-06-AVX Early Therapy in Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
This study is being done to increase awareness for early therapy with Avonex for Multiple Sclerosis (MS) and the cognitive dysfunction that accompanies MS, and to record safety data for Avonex.

Detailed Description
-----------------
This study will address the cognitive dysfunction associated with MS. It will track these changes and show that early intervention with Avonex is effective in slowing MS and its effect on patients. Safety data will also be collected during this study.

Official Title
-----------------
GER-009-06-AVX Early Therapy in Multiple Sclerosis

Conditions
-----------------
Relapsing-Remitting Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CIS (according to indication) or early Relapsing Remitting Multiple Sclerosis Exclusion Criteria: treatment with DMT during the last 12 months
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis, Cognitive Dysfunction in Multiple sclerosis, early treatment, Avonex, interferon beta 1a, Cognitive Dysfunction
Association Between Pseudoexfoliation Syndrome and Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
Pseudoexfoliation syndrome (PEX) is characterized by the deposition of a distinctive fibrillar material in the anterior segment of the eye and was first described in 1917 by Lindberg. It is frequently associated with open angle glaucoma, known as pseudoexfoliation glaucoma, which is one of the most common identifiable forms of secondary open angle glaucoma worldwide. Despite extensive research, the exactchemical nature of the fibrillar material is unknown. It is believed to be secreted multifocally in the iris pigment epithelium, the ciliary epithelium, and the peripheral anterior lens epithelium.

Official Title
-----------------
The Possible Association Between Pseudoexfoliation Syndrome and Diabetes Mellitus in an Egyptian Population

Conditions
-----------------
Lens Diseases

Intervention / Treatment
-----------------
* Device: slit lamp


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Phakic patients presenting to Ophthalmology outpatient clinic Of Assiut University Hospital. Exclusion Criteria: Patients with previous intraocular surgery.

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| study group<br>includes patients who will be diagnosed with Pseudoexfoliation syndrome | Device: slit lamp<br>* Presence of white grayish exfoliation material on the anterior lens capsule and / or the pupillary margin. Poor pupillary dilatation due to atrophy of the dilator pupillae muscle. The presence of pseudoexfoliative material (PXF)in cilliary processes and zonules. presence of PXF material scattered on corneal endothelium. Flecks of the exfoliative material on the anterior chamber which leads to glaucoma.<br>|
| control group<br>age matched controls who do not have Pseudoexfoliation syndrome | Device: slit lamp<br>* Presence of white grayish exfoliation material on the anterior lens capsule and / or the pupillary margin. Poor pupillary dilatation due to atrophy of the dilator pupillae muscle. The presence of pseudoexfoliative material (PXF)in cilliary processes and zonules. presence of PXF material scattered on corneal endothelium. Flecks of the exfoliative material on the anterior chamber which leads to glaucoma.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the percentage of diabetic patients with pseudo-exfoliation syndrome | slit lamp examination of all diabetic patients to get the percentage of those with pseudo-exfoliation syndrome | 10 minutes |
Evaluation of Intravenous Dalbavancin for Peritonitis

Study Overview
=================
Brief Summary
-----------------
This study evaluates the use of Dalbavancin 1500 mg IV x 1 dose for treating patients with gram positive peritonitis in patients requiring peritoneal dialysis.

Official Title
-----------------
Evaluation of Intravenous Dalbavancin for Treatment of Peritonitis in Peritoneal Dialysis Patients

Conditions
-----------------
Peritonitis, Peritonitis Bacterial

Intervention / Treatment
-----------------
* Drug: Dalbavancin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients > 18 years of age actively receiving peritoneal dialysis diagnosed with a gram + peritonitis determined to be a good candidate for dalbavancin treatment by the attending nephrology attending. Exclusion Criteria: Patients with contraindications to dalbavancin 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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dalbavancin|Dalbavancin 1500 mg intravenously x 1 dose|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical cure | resolution of signs and symptoms (e.g. abdominal pain), bacterial eradication, reduction in clinical markers (e.g. peritoneal fluid findings, CRP, etc), and return of peritoneal dialysis functionality | 14 days | 
| Clinical cure | resolution of signs and symptoms (e.g. abdominal pain), bacterial eradication, reduction in clinical markers (e.g. peritoneal fluid findings, CRP, etc), and return of peritoneal dialysis functionality | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment emergent adverse events | Occurrence of any adverse events | 14 days | 
| Treatment emergent adverse events | Occurrence of any adverse events | 28 days |
A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04629991 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04629991 in healthy subjects. Dose exploration will proceed in a step-wise manner, beginning with low doses not expected to have significant biological effects and proceeding to doses approximating or exceeding the anticipated therapeutic level. Doses to be explored may be limited by tolerability, and will not exceed levels previously shown to be tolerable in animals.

Official Title
-----------------
A Phase 1, Randomized, Double Blind (Sponsor Open), Placebo Controlled, Single-Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effect of PF-04629991 in Healthy Volunteers

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: PF-04629991
* Drug: PF-04629991
* Drug: PF-04629991


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy non-smoking men and women body mass index 18-30 kg/m2 Exclusion Criteria: Women must not be able to have children no current infections

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: first of three dosing cohorts<br> | Drug: PF-04629991<br>* Oral; Sequential single dose escalation; three fourteen-day treatment periods per subject in the first cohort; randomized sequence of treatments (one placebo and two PF-04629991 doses)<br>|
| Other: second of three dosing cohorts<br> | Drug: PF-04629991<br>* Oral; Sequential single dose escalation; three fourteen-day treatment periods per subject in the second cohort; randomized sequence of treatments (one placebo and two PF-04629991 doses)<br>|
| Other: third of three dosing cohorts<br> | Drug: PF-04629991<br>* Oral; sequential single dose escalation; three fourteen-day treatment periods per subject in the third cohort; randomized assignment to treatment (placebo or PF-04629991)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics e.g., maximum concentration and area under the concentration-time curve |  | 2 weeks | 
| Safety/Tolerability e.g., reported adverse events and safety laboratory studies |  | 2 weeks | 
| Pharmacodynamics e.g., changes in a peripheral blood biomarker |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rheumatoid arthritis First in human safety pharmacokinetics pharmacodynamics
Study of the Inhibition of [11C]R-rolipram Binding to Brain Phosphodiesterase - 4 (PDE-4) by HT-0712

Study Overview
=================
Brief Summary
-----------------
This Positron Emission Tomography (PET) imaging study is designed to explore the relationship between HT-0712 dose level and inhibition of brain phosphodiesterase-4 activity, in order to optimize the dosage regimens utilized in subsequent trials.

Detailed Description
-----------------
The objective of this project is to demonstrate the inhibition of human brain PDE4 by HT-0712, by measuring the inhibition of [11C]R-rolipram binding, a radiotracer which also binds to and inhibits PDE4. Plasma samples will be drawn to determine if there is a relationship between plasma pharmacokinetics of HT-0712 and its pharmacodynamic effect, as determined through the inhibition of [11C]R-rolipram binding in the brain.

Official Title
-----------------
A PET Study: Single-dose, Open-label Study of the Inhibition of [11C]R-rolipram Binding to Brain Phosphodiesterase - 4 (PDE-4) by HT-0712

Conditions
-----------------
Healthy Elderly Volunteers

Intervention / Treatment
-----------------
* Drug: HT-0712


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Healthy, elderly, non-smoking men and post-menopausal women Ability to give informed consent Main Exclusion Criteria: Current or history of uncontrolled hypertension, major depression, Parkinson's disease, stroke and diabetes. Physical or behavioral conditions that may alter brain function

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 80 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HT-0712<br> | Drug: HT-0712<br>* A range of single oral dose levels will be explored, utilizing 5mg and 25mg strength capsules<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PET measurement of HT-0712 inhibition of [11C]R-rolipram binding | To demonstrate Central Nervous System (CNS) exposure and dose-related inhibition of [11C]R-rolipram binding in brain regions of interest by HT-0712 when compared to baseline [11C]R-rolipram binding in the same individual. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain uptake of [11C]R-rolipram, as determined by PET imaging, associated with both maximal plasma concentration of HT-0712 (Tmax) and overall plasma level exposure (AUC) following administration of different dose levels of HT-0712. | Time-activity curves and plasma AUC will be assessed for [11C]R-rolipram at baseline and at 4-hours post oral administration of HT-0712. | 1 day |
Beetroot Extract and Its Influence on Cardiovascular and Autonomic Recovery From the Effort in Healthy Males

Study Overview
=================
Brief Summary
-----------------
There is no evidence that beetroot extract (Beta vulgaris L.) is advantageous for the recovery of cardiovascular parameters and the autonomic nervous system (ANS) after submaximal aerobic exercise. The objective of this study is to evaluate the effect of beetroot extract supplementation on the recovery of cardiorespiratory and autonomic parameters after a submaximal aerobic exercise session. Healthy male adults will perform a cross-over, randomized, double-blind, and placebo-controlled trial. Beetroot extract (600mg) or placebo (600mg) will be ingested 90 minutes before evaluation in randomized days. Systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse pressure (PP), mean arterial pressure (MAP), heart rate (HR), and HR variability (HRV) indexes will be recorded at Rest and during 60 minutes of recovery from exercise.

Official Title
-----------------
Beetroot Extract and Its Influence on Cardiovascular and Autonomic Recovery From the Effort in Healthy Males

Conditions
-----------------
Healthy Males

Intervention / Treatment
-----------------
* Dietary Supplement: Beetroot extract


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males; Physically active according to International Physical Activity Questionnaire (IPAQ); 18 to 30 old years. Exclusion Criteria: Body mass index BMI <18.5kg/m² and >29.9kg/m²; Smokers; Subjects undergoing pharmacotherapies; Musculoskeletal, metabolic, renal diseases; Root mean squared standard deviation of R-R intervals <15 milliseconds.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Beet protocol<br>Beta vulgaris L. extract (600mg) | Dietary Supplement: Beetroot extract<br>* Beetroot extract capsule<br>|
| Placebo Comparator: Placebo protocol<br>Starch (600mg) | Dietary Supplement: Beetroot extract<br>* Beetroot extract capsule<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability values (milliseconds) |  | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic and diastolic blood pressure values (mmHg) |  | Through study completion, an average of 1 year | 
| Heart rate values (beats per minute) |  | Through study completion, an average of 1 year |
Establishment of a Database for Long-Term Monitoring of Patients With Nephropathic Cystinosis

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Establish a computerized databank to monitor the progress of patients with cystinosis treated with cysteamine. II. Track and monitor all patients including renal transplant, dialysis and post renal transplants.

Detailed Description
-----------------
PROTOCOL OUTLINE: Data are collected from patients and physicians. Information includes disease, treatment, family history, demographic, and physical exam data. The dates of kidney transplantation and/or dialysis initiation are also recorded.

Conditions
-----------------
Cystinosis

Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: Nephropathic cystinosis diagnosis by white-cell cystine measurement, including infantile and late-onset forms

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cystinosis, rare disease, renal and genitourinary disorders
ROSPA - Record on Satisfaction of Patients With Actonel 35 mg Once a Week

Study Overview
=================
Brief Summary
-----------------
To determine the satisfaction of subject with Actonel 35 mg Once a Week in the treatment of post-menopausal osteoporosis. Open, non-controlled, multi-center study.

Official Title
-----------------
Record on Satisfaction of Patients With Actonel 35 mg Once a Week

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: Risedronate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria : Postmenopausal ambulatory women Established osteoporosis Exclusion criteria: History of cancer: basal cell or squamous cell carcinoma-documented 6-month remission, Diagnosis of hypocalcemia, hyperparathyroidism, hyperthyroidism The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Risedronate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction and compliance |  | During all the study |
Benefit of Adding Chemotherapy for Advance Nasopharyngeal Carcinoma (T1-4N2-3M0)

Study Overview
=================
Brief Summary
-----------------
To test the therapeutic ratio of additional chemotheray on advanced nasopharyngeal carcinoma.

Official Title
-----------------
Prospective Randomized Study on Therapeutic Gain Achieved By Addition of Chemotherapy for T1-4N2-3M0 Nasopharyngeal Carcinoma

Conditions
-----------------
Nasopharyngeal Neoplasms, Carcinoma, Squamous Cell

Intervention / Treatment
-----------------
* Procedure: Conventional RT
* Drug: Cisplatin
* Drug: 5-fluorouracil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undifferentiated or non-keratinizing carcinoma Tumor staged as N2-3 No evidence of distant metastasis M0 Performance status:0-2 Marrow: WBC >= 4 and platelet >= 100 Renal: creatinine clearance >= 60 Informed consent Exclusion Criteria: WHO type I squamous cell carcinoma or adenocarcinoma Age >= 70 Palliative intent or tumor extent mandating AP opposing facio-cervical fields Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years Previous radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume Previous chemotherapy Patient is pregnant or lactating

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Conventional RT|nan|
|Drug: Cisplatin|nan|
|Drug: 5-fluorouracil|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure free survival rate |  | 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-specific survival rate |  | 5-year | 
| Overall survival rate |  | 5-year | 
| Complication-free rates |  | 5-year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nasopharyngeal Carcinoma, T1-4N2-3M0