linjc16/ctgov huggingface dataset:
The Nutrition Challenge: A Health Promotion Campaign

Study Overview
=================
Brief Summary
-----------------
The purpose of the challenge is to see if we, as the nutrition experts, can follow the dietary and physical activity guidelines promoted to the public. We have an opportunity to practice what we preach. Scientific evidence demonstrates, knowledge is not enough to change ones'behaviors. It is through positive approaches and lifestyle changes that behavior can be altered. By experiencing the planning, work, and motivation required to make lifestyle changes we can all be better clinicians.

Official Title
-----------------
The Nutrition Challenge: A Health Promotion Campaign

Conditions
-----------------
Health Promotion, Prevention

Intervention / Treatment
-----------------
* Behavioral: Monitoring
* Other: Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Regular access to the internet

Ages Eligible for Study
-----------------
Minimum Age: 17 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 |
| --- | --- |
| Faculty/Staff<br> | Behavioral: Monitoring<br>* Each week participants are asked to record electronically their fruit intake, vegetable intake and minutes of physical activity.<br>Other: Education<br>* Monthly exercise tips handout.<br>|
| Graduate Students<br> | Behavioral: Monitoring<br>* Each week participants are asked to record electronically their fruit intake, vegetable intake and minutes of physical activity.<br>Other: Education<br>* Monthly exercise tips handout.<br>|
| Undergraduate Students<br> | Behavioral: Monitoring<br>* Each week participants are asked to record electronically their fruit intake, vegetable intake and minutes of physical activity.<br>Other: Education<br>* Monthly exercise tips handout.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Cups of Fruit per Day |  | 12-weeks | 
| Average Cups of Vegetables per Day |  | 12 weeks | 
| Average Minutes of Physical Activity Per Week |  | 12-weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Health Promotion, Dietary Guidelines, Physical Activity Guidelines
AI in GIM Diagnosis

Study Overview
=================
Brief Summary
-----------------
This study will use artificial intelligence (AI) for diagnosing gastric intestinal metaplasia.

Detailed Description
-----------------
The patients with previously diagnose gastric intestinal metaplasia (GIM) and have the surveillance gastroscopy will be enrolled. The routine surveillance program will be performed additional to taking photo at both GIM and normal mucosa at least 5 pictures in each. Biopsy will be done to confirm the diagnosis of GIM and normal mucosa. All pictures will be inserted to AI algorithm based on the convolutional neural network (CNN). Then, the AI program will be validated in daily endoscopy compared with pathology. Accuracy, sensitivity and specificity can be calculated by 2x2 table.

Official Title
-----------------
Usefulness of Artificial Intelligence (AI) for Gastric Intestinal Metaplasia Diagnosis

Conditions
-----------------
GIM Diagnosis, Artificial Intellegence

Intervention / Treatment
-----------------
* Diagnostic Test: Artificial intelligence


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: More than 18 years of age Able to sign a consent form Exclusion Criteria: History of gastric surgery Coagulopathy Pregnancy/Breast feeding

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: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: The surveillance EGD in patients with GIM will be done as scheduled and then pictures at GIM lesions and normal mucosa was done and sending to AI for learning. Then AI will be used for diagnosing GIM by using pathology as a gold standard
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GIM patient<br>The patients with GIM will be assessed at both GIM and normal mucosa during endoscopy. | Diagnostic Test: Artificial intelligence<br>* The AI algorithm based on the convolutional neural network (CNN) will be used for analysis the pictures of gastric intestinal metaplasia and normal mucosa. Then AI will be used as a diagnostic tool for GIM during routine endoscopy by using pathology as a gold standard.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of AI for GIM diagnosis | Accuracy, sensitivity, specificity can be calculated by 2x2 table (pathology is a gold standard) | 1 year |
Bilateral Gluteal Fascio-myo-cutaneous Flap in Treatment of Recurrent Pilonidal Disease

Study Overview
=================
Brief Summary
-----------------
Bilateral Gluteal Fascio-myo-cutaneous Advancement Flap is a modified technique used in Treatment of Recurrent Sacrococcygeal Pilonidal sinus

Detailed Description
-----------------
Patients with recurrent pilonidal sinus disease are recruited to undergo Bilateral Gluteal Fascio-myo-cutaneous Advancement Flap technique under spinal anesthesia in order to prevent recurrence.

Official Title
-----------------
Bilateral Gluteal Fascio-myo-cutaneous Advancement Flap in Treatment of Recurrent Sacrococcygeal Pilonidal Disease

Conditions
-----------------
Pilonidal Sinus

Intervention / Treatment
-----------------
* Procedure: Bilateral Gluteal Advancement Flap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with recurrent sacrococcygeal pilonidal disease aging more than 16 years with single or multiple pits were included in the study. Patients included presented with recurrence of pilonidal disease at least six months after the first operation. Exclusion Criteria: Patients aging less than 16 years. Patients unfit for anesthesia. Patients with primary pilonidal disease. Patients with acute pilonidal abscess or active infection.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 70 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: Bilateral Gluteal Advancement Flap<br>Advancement of both gluteal muscles to the midline after release incisions in their fascia. | Procedure: Bilateral Gluteal Advancement Flap<br>* Dissection of both gluteus maximus muscles from their origin in the sacrum, advancement of both muscles is conducted to the midline after creating release incisions in their fascia.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of recurrence | Number of patients who presents with recurrent pilonidal sinus within the follow up period | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of complications | Number of patients who present with wound infection or other morbidity after the operation | 18 months |
Safety and Effect on Memory of PYM50028 in Mild Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effect of PYM50028 administered once daily for up to 12 weeks on the memory and other faculties of subjects with dementia due to Alzheimer's disease.

Official Title
-----------------
Phase II Randomised, Double Blind, Placebo Controlled, Parallel Group Study to Investigate the Safety, Effect on Cognition and Pharmacokinetic Profile of PYM50028 in Subjects With Mild Dementia of the Alzheimer's Type

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

Intervention / Treatment
-----------------
* Drug: PYM50028


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 50 years of age Diagnosis of possible or probable Alzheimer's disease Mini mental state examination score at least 16 Good understanding of both written and verbal English A recent head scan that is consistent with the diagnosis of Alzheimer's disease Exclusion Criteria: Recent history or clinical evidence of significant neurological disease other than dementia due to Alzheimer's disease Known to have another condition that is associated with dementia Use of psychotropic medication within the previous 4 weeks (excluding cholinesterase inhibitors, selective serotonin reuptake inhibitors and venlafaxine) Hormone replacement therapy started or changed within the previous 6 months Received any investigational drugs within the previous 12 weeks

Ages Eligible for Study
-----------------
Minimum Age: 50 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

| Intervention/Treatment |
| --- |
|Drug: PYM50028|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hopkins verbal learning test (revised) total word recall after 12 weeks |  |  | 
| Cambridge neuropsychological test automated battery (CANTAB) paired associate learning (Phytopharm modified form) total adjusted error score after 12 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini mental state examination score |  |  | 
| Clinical dementia rating (overall and sum of boxes) |  |  | 
| CANTAB rapid visual information processing (RVIP) mean latency |  |  | 
| CANTAB RVIP total correct hits |  |  | 
| CANTAB spatial working memory within error, between error and strategy scores |  |  | 
| Clinicians global impression of change |  |  | 
| Disability assessment for dementia score |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dementia, memory, Hopkins verbal learning test, paired associated learning
Dabigatran Etexilate for Stroke Prevention in Patients With Atrial Fibrillation and Mild to Moderate Renal Impairment

Study Overview
=================
Brief Summary
-----------------
Non-interventional, observational study of physicians' use of Dabigatran etexilate for stroke prevention in patients with atrial fibrillation and mild to moderate renal impairment

Official Title
-----------------
Use of Pradaxa® (Dabigatran Etexilate) for Stroke Prevention in Patients With Nonvalvular Atrial Fibrillation and Mild to Moderate Renal Impairment

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: patients with atrial fibrillation foreseen for Pradaxa anticoagulation according to physician's decision for stroke prevention patients with mild or moderate renal impairment age >= 18 years at enrollment Exclusion criteria: - severe renal impairment (Creatinine Clearance < 30 ml/min)

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 |
| --- | --- |
| Atrial fibrillation and mild to moderate renal impairment<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creatinine Clearance (Recalculated Using Entries of Age, Gender, Body Weight and Serum Creatinine Made by the Physician) | The creatinine clearance was recalculated with the Cockcroft-Gault formula using age, gender, body weight, and serum creatinine. | One single observation time point: at the time of prescription before the first intake of dabigatran etexilate |
Adjuvant Colon Cancer w/ ELOXatin®/5 FU Based Regimen: ACCELOX

Study Overview
=================
Brief Summary
-----------------
Adjuvant Colon Cancer With ELOXatin®/5 FU Based Regimen: ACCELOX

Detailed Description
-----------------
It's a study of adjuvant colon carcinoma using ELOXatin/5-FU based chemotherapeutic regimen called ACCELOX as a definitive curative therapy.

Official Title
-----------------
Adjuvant Colon Cancer With ELOXatin®/5 FU Based Regimen: ACCELOX

Conditions
-----------------
Colon Cancer

Intervention / Treatment
-----------------
* Other: Registry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Adjuvant Colon Cancer Exclusion Criteria: Patients with diagnosis other than Colon Cancer.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Registry|Registry|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS, PFS, DFS |  | For the duration of the experiment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adjuvant Colon Cancer
CART-19 Cells For R/R B-ALL

Study Overview
=================
Brief Summary
-----------------
There are limited treatment options for relapse/refractory B-cell acute lymphoblastic leukemia(ALL). However,CART-19 cells has emerged as a powerful targeted immunotherapy for highly refractory CD19+ acute lymphoblastic leukemia (ALL). This study aims to assess the safety and toxicity of CART-19 cells to patients with relapse/refractory B-cell ALL.

Official Title
-----------------
CART-19 Cells For Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia

Conditions
-----------------
Relapsed/Refractory B-cell ALL

Intervention / Treatment
-----------------
* Biological: CART-19 cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed written informed consent Aged between 1-60 years Patients with relapsed/refractory B-cell ALL Cardiac: Left ventricular ejection fraction ≥ 50% Adequate renal and hepatic function Performance status: Karnofsky ≥ 70% Exclusion Criteria: Pregnant or lactating females. Any co-morbidity precluding the administration of CART-19 cells.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>CART-19 cells treat | Biological: CART-19 cells<br>* CART-19 cells treat<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leukemia free survival |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events that are related to treatment |  | 1 year |
Observational Study of Safety and Tolerability of Levemir™ FlexPen™ (Insulin Detemir) in the Treatment of Type 1 and Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Asia. The aim of this observational study is to evaluate the safety and tolerability of Levemir™ FlexPen™ (Insulin Detemir) in the treatment of Filipino patients with Type 1 and Type 2 Diabetes Mellitus.

Official Title
-----------------
Observational Study of Safety and Tolerability of Levemir™ FlexPen™ (Insulin Detemir) in the Treatment of Type 1 and Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with Type 1 or Type 2 Diabetes Mellitus. Newly diagnosed insulin naive patients Patients currently on human insulin or on basal insulin Patients prescribed with Levemir™ FlexPen™ (Insulin Detemir) therapy Usage should be in accordance with the current prescribing information (See attached prescribing information) Exclusion Criteria: Previous history of hypersensitivity to Insulin Detemir (Levemir™) and its excipients (See attached prescribing information) Contraindications and warnings specified in the current prescribing information (See attached prescribing information) Pregnant women, those planning to become pregnant, or women who are breastfeeding Patients who are already on human premix or premix analogue (unless they are going to be shifted to basal-bolus therapy) Children below 6 years old

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 6 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 |
| --- | --- |
| A<br> | Drug: insulin detemir<br>* Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation<br>* Other names: Levemir™;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety profile of Insulin Detemir among Filipino patients |  | 3 months follow-up visit |
The Ultrasonographic Measurement of Quadriceps Muscle Thickness and the Shape of the Femoral Nerve in Patients Undergoing Total Knee Arthroplasty: an Observational Study

Study Overview
=================
Brief Summary
-----------------
For each individual, the femoral nerve shows various shapes and locations. This is because the femoral nerve is located on top of the iliacus muscle, so the shape and location of the femoral nerve seems to be related to the patient's muscle mass. Ultrasound of the quadriceps femoris could represent a widely available, non-invasive, affordable, and reliable tool to evaluate skeletal muscle. We aim to investigate the relationship between muscle mass and the shape of the femoral nerve through this observational study.

Official Title
-----------------
The Ultrasonographic Measurement of Quadriceps Muscle Thickness and the Shape of the Femoral Nerve in Patients Undergoing Total Knee Arthroplasty: an Observational Study

Conditions
-----------------
Total Knee Arthroplasty

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Patients aged 19 years old or older and scheduled for elective total knee arthroplasty Exclusion Criteria: 1. Pre-existing neurologic or anatomic deficits in the lower extremities

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the thickness of rectus femoralis and vastus intermedius, the shape of the femoral nerve | Assessment of quadriceps femoris thickness using ultrasound. Thickness of each muscle is measured from the femur to the inner edge of the vastus intermedius (VI) muscle, or from subcutaneous tissue to the inner edge of the rectus femoris (RF) muscle. The shape of the femoral nerve was measured by ultrasound. | preoperative (about 10 minutes before entering the operating room) |
Quality of Life in Women With X-linked Adrenoleukodystrophy

Study Overview
=================
Brief Summary
-----------------
X-linked adrenoleukodystrophy (X-ALD) is a hereditary white matter disorder caused by mutations in the ABCD1 gene leading to disturbances in the metabolism of fatty acids. This results in an accumulation of very long chain fatty acids (VLCFA) in the cells of the body causing damage to the central nervous system (white matter of the brain and spinal cord). The most common adult-onset X-ALD phenotype is adrenomyeloneuropathy (AMN), a slowly progressive myelopathic variant with demyelination of the long tracts in the spinal cord, clinically manifested as slowly progressive spastic paraparesis, sensory ataxia, bladder and sexual dysfunction. Although this rare disease is inherited X-linked, previous research revealed that up to 80% of heterozygous women develop AMN symptoms during their lifetime. The primary objectives of this study are 1) to assess the prevalence of symptomatic courses in female carriers of X-ALD and 2) to determine the impact of AMN symptoms on the quality of life of affected women in various areas (including everyday life, work, social network, sleep quality, sexuality, mood). Participants are asked to fill in self-report questionnaires, which are available in English, German, French, Spanish, and Italian, and are provided electronically on the online platform Leuconnect (https://www.leuconnect.com) launched by European Leukodystrophies Association (ELA) international (https://elainternational.eu/).

Official Title
-----------------
Quality of Life in Female Carriers of X-linked Adrenoleukodystrophy

Conditions
-----------------
X-linked Adrenoleukodystrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent obtained from the participant Females ≥18 years at the time of consent, with proven X-ALD as defined by Elevated VLCFA values, or Mutation in ABCD1 gene Exclusion Criteria: No informed consent and assent Current pregnancy

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

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

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 |
| --- | --- | --- |
| Number of Participants with AMN Symptoms as Assessed by Adult ALD Clinical Score (AACS) - self-report version |  | Day 0 | 
| Quality of Life in Symptomatic versus Asymptomatic Participants as Assessed by Self-report Questionnaire (SF-36) |  | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adrenoleukodystrophy, Adrenomyeloneuropathy, Brain Diseases, Metabolic, Inborn, Central Nervous System Diseases, Demyelinating Diseases, White Matter Disorder, Genetic Diseases, X-Linked, Peroxisomal Disorders, Metabolic Diseases, Female Carrier, Adrenoleukodystrophy, women, Heterozygous Carrier, Quality of Life