linjc16/ctgov huggingface dataset:
Validation of a Smartphone Application for the Assessment of Patients With Mild Cognitive Impairment: MemScreen

Study Overview
=================
Brief Summary
-----------------
The clinical evaluation of a patient with a cognitive complaint requires neuropsychological tests, evaluating the integrity of memory and other cognitive functions. The initial evaluation is made most often by a doctor (general practitioner). In case of need for further examination, a neuropsychological report is made in consultation memory by a neuropsychologist, with further cognitive tests. The Cognitive Neurology Center at Lariboisière Hospital - Fernand Widal has developed a tool on a digital tablet or smartphone to evaluate cognitive functions: MemScreen. The purpose of this study is to validate this new neuropsychological test on tablet compared to the neuropsychological reference tests.

Detailed Description
-----------------
Characteristics of MemScreen : Smartphone / tablet application developed by the Cognitive Neurology Center at Lariboisière - Fernand Widal Hospital to explore a patient with a cognitive disorder. The application is a self-test by the patient under the supervision of a doctor. The doctor has an account to be able to pass the test to patients. The tablet test is anonymous without the possibility to identify the patient.

Official Title
-----------------
Validation of a Smartphone Application for the Assessment of Patients With Mild Cognitive Impairment: MemScreen

Conditions
-----------------
Cognitive Impairment, Alzheimer Disease

Intervention / Treatment
-----------------
* Diagnostic Test: MemScreen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major patients followed in memory clinic. Performing a neuropsychological assessment less than 6 months old. No visual or motor deficiency impeding the use of a digital tablet. Exclusion Criteria: None.

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| MemScreen<br>Each participants will undergo MemScreen : a screening tool on smartphone for detecting mild cognitive impairment. | Diagnostic Test: MemScreen<br>* Neuropsychological test on smartphone or digital tablet, on self assesment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to detect patients with mild cognitive impairment. | To evaluate the ability of MemScreen to discriminate patients with an objective memory disorder from a validated neuropsychological reference test: the free and cued selective reminding test. | through study completion, an average of 6 months |
Low Calorie Diet in Morbidly Obese Patients

Study Overview
=================
Brief Summary
-----------------
This is a prospective study of morbidly obese patients that are planned to conduct bariatric surgery. The patients included in the study will conduct a low-calorie diet for 6 days prior to the operation and be admitted to hospital for this period. On admission and after finishing the diet a number of tests will be performed: Weigh, height, oral glucose tolerance test, bioimpedance measurement, and samples of blood, urine and a biopsy of subcutaneous adipose tissue.

Detailed Description
-----------------
The study will include 14 patients planned for bariatric surgery with BMI 40-46. The patients will be admitted to hospital 8 days prior to planned surgery and conduct a diet based mostly on fluids (yogurt, soups). Estimated daily calorie intake will be 400-600 kcal. At the day of admission and at day 7 a number of tests will be performed including blood tests, urine test and biometric measurement and a biopsy of subcutaneous adipose tissue. Weight will be measured every morning for the study period. During the operation fatty tissue samples will be taken subcutaneous and from the omentum major. This study is planned as a control group to another study where blood tests and subcutanous adipose tissue was sampled before and 6 days after bariatric surgery. The main aim of this study is to compare changes in adipose tissue and blood samples for patients before and 6 days after surgery to before and 6 days after a low-calorie diet.

Official Title
-----------------
Effect of 6 Days Low Calorie Diet Before Bariatric Surgery

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: Low calorie diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 40-46 kg/m2 The patients must not conduct a diet before admission. Fasting blood glucose <-7 nmol/l Exclusion Criteria: Diabetes mellitus Treatment with antidiabetics Allergy for substances in the planned study-diet

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Low calorie diet<br>Dietary intervention group | Dietary Supplement: Low calorie diet<br>* 6 days of low calorie diet, estimated kcal 400-600/day.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in adipose gene expression signatures in obese subjects after 6 days of low-calorie diet |  | 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in metabolomic signatures in obese subjects after 6 days of low-calorie diet |  | 8 days |
Post-Marketing Surveillance of Long-Term Observation of Gliadel Wafer-Investigation of Vital Prognosis in Patients With High Grade Glioma

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine the survival status of patients enrolled in study GLI01S (all-case observational study).

Official Title
-----------------
Post-Marketing Surveillance of Long-Term Observation of Gliadel Wafer-Investigation of Vital Prognosis in Patients With High Grade Glioma

Conditions
-----------------
Malignant Glioma

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Malignant Glioma, patients enrolled in study GLI01S. Exclusion criteria: Corresponding to contraindication of Gliadel. Not applicable to indications of Gliadel.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Patients with diagnosed malignant glioma treated by surgery, implanted Gliadel wafers 7.7mg, and enrolled in study GLI01S. | Other: No intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate | Survival rate of subjects measured up to 3 year after implantation | Up to 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Malignant Glioma, Glioblastoma multiforme
Assessment of Patient Experience During Treatment for Cancer

Study Overview
=================
Brief Summary
-----------------
Assessing the mindset of cancer patients will help us better understand which patients are having difficulty dealing with the diagnosis and treatment that may not otherwise be fully appreciated by their physicians. By identifying such patients, we may then be able to design and implement strategies that can help improve their coping skills both during the treatment as well as after the completion of treatment. In addition to addressing physical concerns and symptoms, this approach will help address the overall emotional impact of a cancer diagnosis as more patients are living as cancer survivors.

Official Title
-----------------
Assessment of Patient Experience During Treatment for Cancer

Conditions
-----------------
Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically diagnosed carcinoma patients at Stanford cancer center who signed the informed consent form. Exclusion Criteria: Patients with a prognosis of < 6 months life expectancy

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 |
| --- | --- |
| Pathologically diagnosed carcinoma<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Relationship Between the Arthroscopic Anatomy of the Middle Glenohumeral Ligament and the Rotator Cuff Tear Position

Study Overview
=================
Brief Summary
-----------------
The main aim and scope of this study is making observation and comparing the difference in the tear position in the patients suffered form rotator cuff tear with different arthroscopic anatomy of the middle glenohumeral ligament. The results may identify the influence of the middle glenohumeral ligament anatomy type on the rotator cuff tear.

Official Title
-----------------
Relationship Between the Arthroscopic Anatomy of the Middle Glenohumeral Ligament and the Rotator Cuff Tear Position

Conditions
-----------------
Rotator Cuff Tears

Intervention / Treatment
-----------------
* Procedure: Rotator cuff repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: partial or full-thickness but reparable rotator cuff tear; small- to large-sized rotator cuff tears being defined by DeOrio and Cofied4; no improvements after at least 1 month of conservative treatment such as NSAIDs or corticosteroid injection. Exclusion Criteria: massive rotator cuff tears being defined by DeOrio and Cofied; patients with osteoarthritis of the glenohumeral joint; trauma or a history of surgery at the shoulder.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Leaf-like and Cord-like type<br>Under arthroscopy, the anatomy of middle glenohumeral ligament was leaf-like or cord-like. | Procedure: Rotator cuff repair<br>* The patients received the arthroscopic rotator cuff repair.<br>|
| Absent type<br>Under arthroscopy, the anatomy of middle glenohumeral ligament was absent. | Procedure: Rotator cuff repair<br>* The patients received the arthroscopic rotator cuff repair.<br>|
| Burford complex type<br>Under arthroscopy, the anatomy of middle glenohumeral ligament manifested the burford complex. | Procedure: Rotator cuff repair<br>* The patients received the arthroscopic rotator cuff repair.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The arthroscopic tear position (Anetrior/Middle/Posterior) | The rotator cuff was divided into three parts according to the arthroscopic discovery: (1) the anterior part which contained the subsacpularis and one third of the suprascapularis forward; (2) the middle part which contained the two thirds of the suprascapularis backward and one third of the subscapularis forward; (3) the posterior part which contained two thirds of subscapularis backward and teres minor. | During the surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rotator Cuff Tears, Middle Glenohumeral Ligament, Arthroscopic Anatomy
Bioequivalency Study of Oxymorphone Hydrochloride 10 mg Tablets Under Fasted Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to prove the bioequivalence of Oxymorphone Hydrochloride 10 mg Tablets under fasting conditions

Official Title
-----------------
A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalence Study of Oxymorphone Hydrochloride IR 10 mg Tablets, With a Naltrexone Block, Under Fasted Conditions

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Oxymorphone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to oxymorphone hydrochloride or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxymorphone Hydrochloride<br>Tablet | Drug: Oxymorphone<br>* 10 mg tablet<br>* Other names: Opana;|
| Active Comparator: Opana<br>Tablet | Drug: Oxymorphone<br>* 10 mg tablet<br>* Other names: Opana;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioequivalence determined by statistical comparison Cmax |  | 9 days |
Treatment of Chronic Leg Ulcer in Outpatient's Department and i Primary Care - Wound Size and Inflammation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the rate of wound healing using sharp debridement using curette and to compare between such intensive treatment at hospital and treatment in primary care. A correlation between change in wound size and pro-inflammatory cytokines will also be made.

Detailed Description
-----------------
Subjects with chronic venous leg ulcers are treated 3 times a week in the hospital for 6 weeks with weekly sharp debridement. Wound size, pro-inflammatory cytokines, smears and photo are made weekly. The treatment countinue thereafter in primary care 3 times a week in 12 weeks. Wound size, pro-inflammatory cytokines, smears and photo are made every 14 day at the hospital.

Official Title
-----------------
Treatment of Chronic Legg Ulcer in Outpatient's Department and i Primary Care - Wound Size and Inflammation

Conditions
-----------------
Treatment of Leg Ulcer, Sharp Debridement, Proinflammatory Cytokines

Intervention / Treatment
-----------------
* Procedure: Sharp debridement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ulcus cruris venosoum AAI > 0.9 age 18-80 adress Oslo area wound size 2.5-100 cm2 wound duration > 6 weeks. Exclusion Criteria: Diabetes mellitus Immunosuppresion antibiotics < 14 days local antiseptic treatment < 1 week clinical infection.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Sharp debridement|After use of local anestetics a sharp currette is used to debride slough and nonviable tissue from the ulcer surface until a healthy tissue is seen.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment of chronic leg ulcer in outpatient's department at hospital and in primary care - wound size and inflammation. | Wound size | 01.08.10-01.08.13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment of chronic leg ulcer in outpatient's department at hospital and in primary care - wound size and inflammation. | Pro-inflammatory cytokines | 01.08.10-01.08.13 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
leg ulcer, wound therapy, Pro-inflammatory interleukins
Patient Reported Outcomes in Adults With Pediatric-onset Hypophosphatasia Treated With Strensiq® (Asfotase Alfa)

Study Overview
=================
Brief Summary
-----------------
This observational study will evaluate the treatment effect of Strensiq (asfotase alfa) on Patient Reported Outcomes (PROs) in participants diagnosed with pediatric-onset hypophosphatasia (HPP) registered in the patient support program managed by OneSource™.

Detailed Description
-----------------
Participants consenting to participate in this study will be asked to complete study questionnaires by phone interviews upon consenting (Baseline), and up to 12 months following treatment initiation with asfotase alfa. Demographic and clinical characteristics of participants in the study will be characterized. This is an observational study and no intervention will be administered. Participants will be treated in accordance with standard of care.

Official Title
-----------------
A Prospective Study to Evaluate the Patient Reported Quality of Life Prior to and After Strensiq® Treatment in Adults With Pediatric Onset Hypophosphatasia

Conditions
-----------------
Hypophosphatasia

Intervention / Treatment
-----------------
* Drug: asfotase alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 18 years old Clinical diagnosis of pediatric-onset HPP Naïve to asfotase alfa Expected to begin treatment with asfotase alfa for HPP Registered in OneSource Willing and able to provide voluntary, verbal informed consent to participate in this study Exclusion Criteria: Pregnant or breastfeeding Unable to speak and understand English Unable or unwilling to complete the study surveys via telephone interview at the protocol-required time points

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Participants with Pediatric-onset HPP<br>Adult participants diagnosed with pediatric-onset HPP, newly prescribed treatment with asfotase alfa, and registered in the patient support program managed by OneSource. | Drug: asfotase alfa<br>* This is an observational study and no intervention will be administered. All participants will be treated by their physician in accordance with standard of care. All medications are commercially available and will be used as directed by the treating physician.<br>* Other names: Strensiq®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline In Patient Reported Outcomes (PROs) Questionnaire Scores |  | Baseline, up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypophosphatasia, HPP, Patient reported outcome, Pediatric-onset hypophosphatasia, Pediatric-onset
Insulin Resistance in Type I Diabetes in Pediatric Care

Study Overview
=================
Brief Summary
-----------------
24 children (12 African-American, Hispanic, or American Indian, 12 Caucasian) previously diagnosed with type 1 diabetes mellitus will participate in this pilot study to evaluate the presence of hepatic and peripheral insulin resistance. The investigators will use this pilot information to test the hypothesis that insulin resistance occurs in some children with type 1 DM, is secondary to underlying risk factors, and is responsible for increased insulin needs. Methods will include a step-up hyperinsulinemic euglycemic clamp and infusion of the stable isotope 6,6-[2H2]-glucose. Patient and parent interviews will be conducted to gather information about nutritional intake, ethnicity, family history, and socioeconomic status. The investigators will also measure inflammatory cytokines and free fatty acids to determine whether they are associated with differences in insulin resistance among type 1 diabetes mellitus patients.

Official Title
-----------------
Insulin Resistance in Type I Diabetes in Pediatric Care

Conditions
-----------------
Type 1 Diabetes

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously diagnosed with type 1 diabetes ages 9 -11 tanner 1 or 16-23 tanner 4-5 Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 23 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<br>Hyperinsulinemic euglycemic clamp | Other: Clamp<br>* Insulin sensitivity, Hepatic glucose production, Evaluation of inflammation, Socioeconomic status, Ethnicity and family history<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatic glucose output |  | Baseline |