linjc16/ctgov huggingface dataset:
Acquisition of Normative Data for Musculoskeletal Ultrasound in Children

Study Overview
=================
Brief Summary
-----------------
The primary objective is to establish normative data for Canadian children for the shoulder, elbow, wrist, finger, hip, knee, ankle and toe joint including the relevant tendons surrounding the joint.

Detailed Description
-----------------
The respective joints will be assessed through ultrasonography and data will be collected and analyzed

Official Title
-----------------
Acquisition of Normative Data for Musculoskeletal Ultrasound in Children

Conditions
-----------------
Normative Data Study of Joints of Healthy Children

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy children Exclusion Criteria: Do not suffer from any condition that might have an effect on their joints.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 18 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study Evaluating Safety & Efficacy of Subcutaneous Methylnaltrexone on Opioid-Induced Constipation in Cancer Subjects

Study Overview
=================
Brief Summary
-----------------
This purpose of this study is to evaluate the safety and effectiveness of a subcutaneous (injection beneath the skin) form of methylnaltrexone in subjects who have cancer-related pain and constipation from taking opioids. The length of participation will be up to 7 weeks.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Subcutaneous Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Subjects With Cancer-Related Pain

Conditions
-----------------
Opioid-Induced Constipation

Intervention / Treatment
-----------------
* Drug: methylnaltrexone
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Is a man or woman aged 18 years or older. Has a body weight >= 38 kg. Has cancer (active or in remission), and has cancer-related pain (ie, pain due to cancer or treatment of cancer). Has a life expectancy of >= 6 months. Has a performance status of 0, 1, or 2 based on the Eastern Cooperative Oncology Group (ECOG) scale. Is taking opioids for cancer-related pain, and not just as-needed doses. Has a diagnosis of OIC as determined by the investigator. Is willing to follow the protocol instructions on laxative use during the study. Exclusion Criteria: Has a history of chronic constipation before starting opioids. Has renal disease receiving dialysis. Has an ostomy for stools. Is a pregnant or breastfeeding woman.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: Group 1 Active Drug<br>Methylnaltrexone | Drug: methylnaltrexone<br> <br> * Other names: MOA-728;|
| Placebo Comparator: Group 2 Non-Active Drug<br>Placebo | Drug: placebo<br> <br> * Other names: Inactive;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel movement within 4 hours after the first dose. Collection of adverse events, vital signs measurements, and laboratory assessments. |  | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Bowel movements within 4 hours after at least 2 of the first 4 doses. 2. Bowel movements within 4 hours after all doses. 3. The time to bowel movement after the first dose. |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
opioid induced constipation, Cancer patients, methylnaltrexone
Effect of Fish Oil on Adiposity and Atherogenic Factors in Type 2 Diabetic Women

Study Overview
=================
Brief Summary
-----------------
whether the intake of n-3 PUFA has additional effects on insulin sensitivity and adiposity (total fat mass and adipocyte morphology and function) in T2D women. n-3 PUFA supplementation might influence inflammatory genes expression in the adipose tissue of T2D patients.

Detailed Description
-----------------
Thus, the present study was designed to evaluate the effects of n-3 PUFAs dietary supplementation on lipid and glucose homeostasis and to address the impact of this treatment on adiposity and adipose tissue gene expression in T2D women.A total of 27 T2D women (BMI 27-35kg/m², age 40-60 y) were randomly allocated to two months of 3 g/day of either fish oil (1.8 g n-3 PUFA) or placebo (paraffin oil), in a double-blind parallel design.

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

Intervention / Treatment
-----------------
* Drug: Fish oil (Maxepa)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetic postmenopausal women glycaemia of 7.87-14.0 mmol/l, HbA1c of 7 to 10.5% plasma triglycerides between 1.72-4.6 mmol/l, aged between 40 -60, BMI: 27-40 kg/m2 able to swallow tablets Exclusion Criteria: patients with abnormal renal, hepatic and thyroid functions as determined by physical examination, blood cell count and standard blood biochemical profile patients with gastrointestinal disorders patients treated with thiazolidinediones or insulin

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 Years

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

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: Fish oil (Maxepa)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of 2 month treatment on: |  |  | 
| adiposity (total fat mass, adipocyte morphology), atherogenic markers and insulin sensitivity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the underlying mechanisms of the observed results and tried to define new targets of fish oil metabolic effects |  |  | 
| and the impact of fish oil on systemic inflammatory markers and adipose tissue inflammatory genes. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fish oil, Type 2 diabetic women, adiposity, adipose tissue inflammation, PAI-1, Insulin sensitivity
The Effect of a Nutritional Supplement Product Containing Cactus Fruit Juice (Nopalea) on C-Reactive Protein

Study Overview
=================
Brief Summary
-----------------
This study has been developed to investigate the anti-inflammatory effects of a commercial product (Nopalea) containing Prickly Pear Cactus Fruit Juice in healthy adults. The research method employs a double blind, placebo controlled, and time-series (repeat measures) design with high-sensitivity C-Reactive Protein (HS-CRP) serving as a marker for inflammation - testing for levels of CRP at time points: baseline (pre-test), 8 weeks (60 days) and 12 weeks (90 days). The final time point (i.e., 12 weeks) will serve as the post-test. It is expected that baseline CRP levels in healthy participants will decline.

Official Title
-----------------
The Effect of a Nutritional Supplement Product Containing Cactus Fruit Juice (Nopalea) on C-Reactive Protein (NOPALEA)

Conditions
-----------------
Inflammation

Intervention / Treatment
-----------------
* Dietary Supplement: NOPALEA


Participation Criteria
=================
Eligibility Criteria
-----------------
Live within traveling distance of the research center. Access to a telephone in their residence. Between 35 and 75 years of age Not currently ingesting Nopalea Not pregnant, planning to become pregnant, or nursing a child Not currently taking anti-inflammatory medications Medically stable - i.e. no recent major change in the last 3 weeks of prescription or non- prescription medication Not diagnosed with Type 1 Diabetes Not diagnosed with depression Not diagnosed with an acquired or congenital immune system deficiency

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 75 Years

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

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Apricot<br>Supplement: Apricot Juice | Dietary Supplement: NOPALEA<br> <br> |
| Experimental: Nopalea<br>Supplement: Nopalea | Dietary Supplement: NOPALEA<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HS-CRP |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CRP, Nopalea, Fruit, Juice
Follow-up Study to Evaluate Long-term Safety and Tolerability of Immunization With AD03 Applied During AFF005A

Study Overview
=================
Brief Summary
-----------------
This is a phase Ib follow-up study to evaluate long-term safety and tolerability of immunization with AFFITOPE AD03 applied during AFFiRiS 005A.

Official Title
-----------------
Phase Ib Follow-up Study to Evaluate Long-term Safety and Tolerability of Immunization With AFFITOPE AD03 Applied During AFFiRiS 005A

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent signed and dated by the patient and the caregiver. Patients having participated in AFFiRiS 005A and received ≥1 vaccination with AFFITOPE AD03 Availability of a partner/caregiver knowing the patient and being able to accompany the patient to the visits and being available for the telephone phone calls Exclusion Criteria: Patients having received no vaccination with AFFITOPE AD03 History of questionable compliance to visit schedule; patients not expected to complete the clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 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 |
| --- | --- |
| AFFITOPE AD03 with adjuvant<br> | |
| AFFITOPE AD03 without adjuvant<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety/Tolerability | Withdrawal criteria (continuation decision) Number of patients who withdraw due to AEs Reason for withdrawal Number and kind (description) of AEs Number and kind (description) of SAEs Changes from study AFF005A in: Physical and neurological examination/ Concomitant medication/ Vital signs (blood pressure, heart rate, respiratory rate, body temperature)/ Body mass (weight)/ MRI of the brain/ ECG/ Laboratory assessment (haematology, biochemistry, coagulation, serology, APP crossreactivity and urinalysis) | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Efficacy | Changes from study AFF005A in: CIBIC plus (Clinician's Interview-Based Impression of Change, + carer interview) ADAScog (Alzheimer Disease Assessment Scale-cognitive) CERAD plus (The Consortium to Establish a Registry for AD) Neuropsychiatric inventory Activity of daily living Quality of life in patients with Alzheimer's disease Investigator's global evaluation scale MRI brain volumetry | 52 weeks | 
| Immunological | - Titre of antibodies specific for the immunizing peptide, N-terminal part of Aβ, Aβ itself, N-terminally truncated and Pyroglutamate-modified versions of Aβ, and KLH by ELlSA | 52 weeks |
Urgent Medical and Surgical Conditions During Flights

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the incidence and status of urgent medical conditions. After defining the urgent situations, the investigators will evaluate the adequacy of the standard medical kits and trainings.

Detailed Description
-----------------
In this study, the incidence and status of urgent medical conditions, the attitudes of health professionals who encounter such conditions, adequacy of Aerospace Medical Association (ASMA) suggested medical kits and training of cabin crew in data-received-company aircrafts and the demographic data of patients have been evaluated.

Official Title
-----------------
Inflight Emergencies During Eurasian Flights

Conditions
-----------------
CAD, Syncope, Arrest, Vertigo, Pain, Chronic Obstructive Pulmonary Disease, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All passengers (no age limitations) needed urgent medical support during flights Exclusion Criteria: Patients whom medical urgency records are insufficient

Ages Eligible for Study
-----------------
Minimum Age: 2 Weeks
Maximum Age: 95 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 |
| --- | --- |
| Sick passangers<br>Passengers or cabincreew whom needed urgent medical supports during flights with completed medical records. (Aforementioned Flight Company records complaints, symptoms and diagnoses, demographic data, the mortality of those who request medical aid, whether medical treatment is performed by the cabin crew or by a medical professional on the plane, as well as those conditions which resulted in an emergency landing and dead). All ages are included. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of the urgent medical demands during flights |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inflight emergencies
the Hypertrophic Scar Prevention of BMT101.

Study Overview
=================
Brief Summary
-----------------
An Independent Evaluator-Blind, Dose-Escalation, Untreated-Controlled, Within-Subject, Phase 2a Therapeutic Exploratory Clinical Trial

Detailed Description
-----------------
As a comparative evaluation between the control group (untreated-control) and the study group (treatment) within a subject, it was decided to assign ten subjects to each of the three dose groups.

Official Title
-----------------
An Independent Evaluator-Blind, Dose-Escalation, Untreated-Controlled, Within-Subject, Phase 2a Therapeutic Exploratory Clinical Trial to Evaluate the Efficacy and Safety of BMT 101 Administration for the Prevention of Hypertrophic Scar

Conditions
-----------------
Hypertrophic Scar

Intervention / Treatment
-----------------
* Drug: BMT101


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male and female adults aged 19-55 years Those who plan to undergo a revision surgery to remove hypertrophic scar resulted from a previous abdominal surgery Those who voluntarily signed the written consent and agreed to participate in the study. Exclusion Criteria: Pregnant or lactating women Those with clinically significant systemic disease (e.g. diabetes, hematologic disease, allergic or immunogenic systemic skin disease)

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMT101<br>BMT101 injection (treatment) | Drug: BMT101<br>* Intradermal injection to each of 3 dose-groups.<br>* Other names: cp-asiRNA;|
| No Intervention: control<br>Un-treated control | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reducing the hypertrophic scar after scar revision surgery | to evaluate Differences in Visual Analogue Scale (VAS) score between the study group and the control group when independent evaluators assessed the severity of the hypertrophic scars. | Week 2, 6, 10, 22 | 
| Safety evaluation of BMT101 | To assess severity and frequency of reported adverse events and clinically-relevant changes in laboratory testing after elective revision of a hypertrophic scar | Week 2, 6, 10, 22 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
siRNA, scar prevention, scar
Low Dose Ketamine as an Adjunct to Fentanyl in Outpatient Tonsillectomy

Study Overview
=================
Brief Summary
-----------------
Comparing patients receiving subanesthetic doses of Ketamine vs placebo to see if it can reduce narcotic needs for patients receiving a tonsillectomy and adenoidectomy

Official Title
-----------------
A Prospective Study of Low Dose Ketamine as an Adjunct to Fentanyl in Pediatric Patients Following Outpatient Tonsillectomy and Adenoidectomy

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:between 3 and 12 years of age ASA 1 or 2 Exclusion Criteria: did not consent

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 12 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: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Low dose ketamine given | Drug: ketamine<br>* Single IV dose of 0.1 mg/kg of ketamine<br>|
| Placebo Comparator: 2<br>Saline given as control | Drug: Placebo<br>* Saline given of equal volume to drug<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of post op narcotic use |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| degree of nausea and vomiting |  | 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain
Geriatric Assessments in Elderly Diffuse Large B-cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
This study investigate the impact of comprehensive geriatric assessments using activity of daily living (ADL), instrumental activity of daily living (IADL), and Charlson's comorbidity index (CCI) on survival and toxicities in Korean patients with diffuse large B-cell lymphoma (DLBCL) treated with R-CHOP.

Official Title
-----------------
Multi-center, Prospective Cohort Study to Investigate the Impact of Comprehensive Geriatric Assessments on Survival and Toxicities in Elderly Diffuse Large B-cell Lymphoma Patients Treated With R-CHOP

Conditions
-----------------
Lymphoma, Large B-cell, Diffuse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with newly diagnosed CD20+ DLBCL 65 years old or over Scheduled to receive R-CHOP chemotherapy Informed consent Exclusion Criteria: Other histology than CD20+ DLBCL Primary central nervous system DLBCL Patients with a diagnosis of cancer (other than basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, well differentiated thyroid cancer [papillary or follicular thyroid cancer]) within 3 years before the study entry or with any treatment for cancer within 3 years before entry Consent withdrawal

Ages Eligible for Study
-----------------
Minimum Age: 65 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 patients with DLBCL<br>Elderly patients (age>=65 years) with DLBCL treated with R-CHOP chemotherapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event-free survival | Event-free survival was defined as death, relapse from complete remission, progression during or after treatment, and discontinuation or changes of therapy during treatments | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 5 years | 
| Progression-free survival |  | 5 years | 
| Cumulative incidence of grade 3/4 adverse events and premature treatment discontinuation |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
geriatric assessment, diffuse large B-cell lymphoma, activity of daily living, instrumental activity of daily living, Charlson's comorbidity index