linjc16/ctgov huggingface dataset:
Immune Response Analysis to Influenza Vaccine in Elderly Aged Over 65 Years

Study Overview
=================
Brief Summary
-----------------
This study is the first step in a clinical research program that aims to study the immune response to influenza vaccine in the elderly and then to propose a new method of administering the vaccine. Influenza can cause severe complications in patients at risk (elderly and subjects vulnerable because of a chronic underlying disease). Over 90% of deaths related to influenza occur in people aged over 65 years. Vaccination is the most effective way to prevent infection. The World Health Organization recommends annual immunization for people at risk, including all persons aged over 65 years, to reduce the risk of morbidity and mortality related to influenza. However, the immune response to influenza vaccine appears to be lower in elderly than in young people.

Official Title
-----------------
Immune Response Analysis to Influenza Vaccine in Elderly Aged Over 65 Years

Conditions
-----------------
Immune Response

Intervention / Treatment
-----------------
* Procedure: Blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject aged 65 years or over Influenza vaccination without adjuvant, within 3 weeks and 3 months before inclusion visit Legal capacity to consent Subject had given written consent before his participation Exclusion Criteria: Adjuvanted influenza vaccine (e.g: Fluad, Gripguard) Live vaccines within 3 weeks before and after influenza vaccination Inactivated vaccines within 2 weeks before and after influenza vaccination Chronic disease non-stabilized under treatment Severe malnutrition in the opinion of the investigator Congenital immunodeficiency Chemotherapy or radiotherapy over the last 6 months Immunosuppressive therapy or corticosteroid (daily dose of prednisone or equivalent >/= 20 mg/d over 14 days) from 1 month before vaccination until the study visit Participation in another clinical study that could interfere with the present study

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: antibody rates<br> | Procedure: Blood sample<br>* Blood sample of 7 ml<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| antibody rates after influenza vaccination |  | up to 3 months after vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Influenza vaccine, immune response, elderly
Discontinuation of Dasatinib in Patients With Chronic Myeloid Leukemia-CP Who Have Maintained Complete Molecular Remission for Two Years; Dasatinib Stop Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess whether dasatinib can be discontinued without occurrence of molecular relapse in patients with chronic myeloid leukemia in chronic phase in complete molecular remission (CMR) while on dasatinib.

Official Title
-----------------
Discontinuation of Dasatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase Who Have Maintained Complete Molecular Remission for Two Years; Dasatinib Stop Trial

Conditions
-----------------
Chronic Myeloid Leukemia

Intervention / Treatment
-----------------
* Drug: Dasatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic Myeloid Leukemia in the Chronic Phase. Patients with BCR-ABL-negative checks. 15 years old over. ECOG performance status (PS) score 0-2. Adequate organ function (hepatic, renal and lung). Signed written informed consent. Exclusion Criteria: A case with the double cancer of the activity. Women who are pregnant or breastfeeding. Patients with complications or a history of severe. Patients with mutation of T315I、F317L、V299L. Patients with additional chromosome abnormalities. The case of Pleural effusion with poor control. Patients with a history of hematopoietic stem cell transplantation.

Ages Eligible for Study
-----------------
Minimum Age: 15 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: dasatinib<br> | Drug: Dasatinib<br>* 100mg QD<br>* Other names: BMS-354825;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The overall probability of maintenance of complete molecular remission at 12 months after stopping dasatinib. |  | at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of complete molecular remission that will be sustained after dasatinib rechallenge. |  | at 12 months |
Using Ultrasound to Predict Response to Intraarticular Corticosteroids in Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
A study using characteristics on ultrasound to predict response to intraarticular steroid injections in patients with knee osteoarthritis. The hypothesis is that patients with inflammation on ultrasound will have a better response to corticosteroid injections compared to patients without inflammation.

Official Title
-----------------
Using Ultrasound to Predict Response to Intraarticular Corticosteroids in Knee Osteoarthritis: A Randomized Placebo-Controlled Clinical Trial

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: triamcinolone acetonide
* Drug: saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: knee pain diagnosis of osteoarthritis in affected knee Exclusion Criteria: intraarticular corticosteroids in affected knee within past three months primary inflammatory connective tissue disease (ie rheumatoid arthritis) currently taking oral corticosteroids

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Corticosteroid Injection<br>40 mg of intraarticular triamcinolone acetonide | Drug: triamcinolone acetonide<br>* single intraarticular injection of 40 mg of triamcinolone acetonide<br>|
| Placebo Comparator: Placebo Injection<br>Intraarticular injection of 0.9% saline | Drug: saline<br>* Single intraarticular injection of 1 ml of 0.9% saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Western Ontario and McMasters Universities Arthritis Index (WOMAC) Pain Subscale | WOMAC pain subscale range 0-20 (0=best, 20=worst) | baseline to 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteoarthritis, knee, corticosteroids, ultrasound
Safety, Tolerance, Efficacy and Pharmacokinetics of Multiple Doses of sCD4-PE40 in the Treatment of HIV-Infected Individuals

Study Overview
=================
Brief Summary
-----------------
To investigate the safety and tolerance of an increasing number of infusions per week of alvircept sudotox ( sCD4-PE40; soluble CD4-Pseudomonas exotoxin ) at a fixed dose when administered to HIV-1-infected individuals. To investigate the effect of sCD4-PE40 on the following parameters: T lymphocyte subsets, plasma HIV RNA and cellular HIV proviral DNA in PBMC and CD4 cells, p24 levels, serum beta-2 microglobulin, and neopterin levels.

Official Title
-----------------
Safety, Tolerance, Efficacy and Pharmacokinetics of Multiple Doses of sCD4-PE40 in the Treatment of HIV-Infected Individuals

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Alvircept sudotox


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: HIV positivity confirmed by Western blot. CD4 count of 100 - 500 cells/mm3 on a morning draw within 3 weeks prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: Concurrent neoplasms other than basal cell carcinoma of the skin, in situ carcinoma of the cervix, or nondisseminated Kaposi's sarcoma. Hemophilia or other clotting disorders. Major organ allograft. Significant cardiac, hepatic, renal, or CNS disease. Prior Medication: Excluded: Antiretroviral agents within 2 months prior to study entry. Known anti-HIV medication within 60 days prior to study entry. Prior immunomodulators (e.g., systemic steroids, interferons, or interleukins) or other chemotherapy. Prior Treatment: Excluded: Prior radiation therapy. Active substance abuse.

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

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

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

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

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Alvircept sudotox|nan|

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
-----------------
Recombinant Proteins, Acquired Immunodeficiency Syndrome, Antigens, CD4, AIDS-Related Complex
Functional MRI of Stress in Obesity

Study Overview
=================
Brief Summary
-----------------
To examine the influence of obesity on brain activation during food cue, stress, and neutral relaxing conditions

Detailed Description
-----------------
Subjects will participate in an fMRI session to examine changes in frontal and limbic brain regions with food cues, stress and neutral/relaxing imagery

Official Title
-----------------
Functional Magnetic Resonance Imaging of Stress in Obesity

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between ages 18-50 years old. Able to read and write. negative urine toxicology screens during intake appointments indicating no history of current or past dependence on alcohol or illicit drug use. WOMEN: have a regular menstrual cycle. BMI: 30 < BMI < 35 for obese subjects (upper limit of 35 selected given our experience with heavier individuals fitting comfortably in the fMRI scanner) and 18.5 < BMI <25 for normal weight subjects (Institute, 2006) Exclusion Criteria: any major neurological illness or injury and any current or prior clinically significant mental health (including PTSD) or substance use disorder (with exception of nicotine dependence) as determined by SCID interview; Regular use of any psychoactive drugs including anxiolytics and antidepressants. Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, liver, thyroid pathology; subjects on medications for any medical condition will be excluded. Any subjects with foreign ferromagnetic metal objects in their body or other MR contraindications will be excluded including subjects who work as welders. Women on oral contraceptives, peri- and post-menopausal women, and pregnant or lactating women (as alterations in stress response are associated with these states).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Healthy<br>Subjects deemed to be medically healthy | |
| Obese<br>Subjects deemed to be medically obese | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No outcome measures for this study, this is an imaging study only |  | Upon study completion |
The Effects of Spinal Mobilizations on Neck Pain and Sympathetic Nervous System Activity in People With Neck Pain

Study Overview
=================
Brief Summary
-----------------
This study investigates the effects of spinal mobilizations on neck symptoms and sympathetic nervous system activity in people with neck pain.

Official Title
-----------------
The Effects of Spinal Mobilizations on Neck Pain and Sympathetic Nervous System Activity in People With Neck Pain

Conditions
-----------------
Neck Pain

Intervention / Treatment
-----------------
* Other: Neck passive mobilizations
* Other: Manual contact


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary complaint of neck pain Non-traumatic history of onset Pain has a clear mechanical aggravating and easing positions or movements Limited range of motion Local provocation tests produce recognisable symptoms A positive expectation that mobilisations will help Exclusion Criteria: No neurological deficit No signs of central hyperexcitability Referral to other health professional to exclude red flags not required

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neck passive mobilizations<br> | Other: Neck passive mobilizations<br>* Passive mobilizations performed to the neck of the participant by a Physiotherapist<br>|
| Placebo Comparator: Manual contact<br> | Other: Manual contact<br>* Manual contact applied to the neck of the participant by a Physiotherapist<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global rating of change scale | Measures overall improvement as perceived by the participant. It is a 15-point scale ranging from -7 (a very great deal worse), through 0 (no change), to +7 (a great deal better). Values above 0 denote improvement following treatment, 0 denotes no change, and values below 0 denote worsening after the treatment. The higher the value, the greater the improvement; the lower the value, the greater the worsening. The participant will be asked to provide a value that represents their change (they may give 0, which denotes no change) following the intervention. | Immediately after the intervention | 
| Change in pain reported by the participant during neck movements | The participant will be asked to report if he/she has pain on each of the following movements: flexion, extension, side flexion and rotation | Baseline and immediately after the intervention | 
| Change in Sympathetic nervous system activity using skin conductance | Skin conductance in the index and ring finger will be measured | Baseline, during the intervention and immediately after the intervention |
Early Oral Feeding After Total Gastrectomy for Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the possibility of shortening postoperative hospital stay after gastrectomy by early oral feeding as a component of an enhanced recovery protocol (ERAS).

Official Title
-----------------
A Randomized Clinical Trial of Early Oral Feeding as a Component of Accelerated Recovery Protocol After Total Gastrectomy for Cancer

Conditions
-----------------
Adenocarcinoma of the Stomach

Intervention / Treatment
-----------------
* Dietary Supplement: Early oral feeding


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Total gastrectomy for cancer Age 18 - 80 years Informed consent Exclusion Criteria: Numerous hepatic and peritoneal metastases Extended resections (pancreas, colon) Preoperative malnutrition requiring total parenteral nutrition Emergency surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early oral feeding<br>Early oral feeding starting with liquids on postoperative day (POD) 1, followed by a soft diet on POD 2, and solid foods on day 3 | Dietary Supplement: Early oral feeding<br>* Oral fluids starting on POD 1, followed by a soft diet (thin purée six times a day) on day 2, and regular solid diet thereafter<br>|
| No Intervention: Delayed oral feeding<br>Delayed oral feeding starting with liquids on postoperative day (POD) 4, followed by a soft diet on POD 5, and solid foods on day 6 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative hospital stay | Time between surgery and patient discharge | Participants will be followed for the duration of hospital stay, an expected average of 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity | Any complication occurring during hospital stay | Participants will be followed for the duration of hospital stay, an expected average of 8 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastrectomy, gastric cancer, oral feeding, complications
Safety and Pharmacokinetics (PK) of hOKT3g1 (Ala-Ala) in Type 1 Diabetes Mellitus (T1DM)

Study Overview
=================
Brief Summary
-----------------
To assess the tolerability and safety of hOKT3g1 (Ala-Ala) after a 12-day dosing regimen administered via intravenous infusion. To assess the pharmacokinetics of hOKT3g1 (Ala-Ala).

Official Title
-----------------
Evaluation of Tolerability, Safety, and Pharmacokinetics of hOKT3g1 (Ala-Ala)

Conditions
-----------------
Diabetes Mellitus, Insulin-Dependent

Intervention / Treatment
-----------------
* Drug: hokt3g1 (ALA-ALA)


Participation Criteria
=================
Eligibility Criteria
-----------------
To be eligible participants will have Type 1 diabetes, diagnosed within the previous 12 months and established by standard American Diabetes Association criteria. All participants will have autoantibodies: either anti-GAD65, anti-ICA512, or if treated with insulin for less than 7 days, anti-insulin. The age range will be between 8 and 30 years; and a minimum weight of 34 kg.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 30 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: hokt3g1 (ALA-ALA)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Clinical PRoduct DevelOpment StudyinG the QT Ultrasound® BReast ScannEr With Volunteer SubjectS

Study Overview
=================
Brief Summary
-----------------
Subjects will be scanned on the QT Ultrasound Breast Scanner. For subjects that may have breast calcifications and/or mass(es) and/or other finding(s) on the QT scan image(s), standard imaging modalities (e.g., mammogram and HHUS) will be performed per ACR recommendations. If available, subjects may provide copies of their breast imaging exams and related reports. Demographics and medical history will be collected.

Official Title
-----------------
Clinical PRoduct DevelOpment StudyinG the QT Ultrasound® BReast ScannEr With Volunteer SubjectS

Conditions
-----------------
Volunteer Subjects

Intervention / Treatment
-----------------
* Other: QT Ultrasound Breast Scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years old Willing and able to provide written, signed informed consent Willing and able to comply with all study procedures Exclusion Criteria: Inability to tolerate the scan Present infection risk Allergies to device materials Inability to successfully fit breast into the investigational device Currently pregnant as reported by the subject Body weight greater than 400 lbs. (180 kg) Any other conditions that the Investigator determines to interfere with the conduct of the study or evaluation of results

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QT Ultrasound breast scan<br> | Other: QT Ultrasound Breast Scan<br>* Subjects will be scanned on the QT Ultrasound Breast Scanner. For subjects that may have breast calcifications and/or mass(es) and/or other finding(s) on the QT scan image(s), standard imaging modalities (e.g., mammogram and HHUS) will be performed per American College of Radiology (ACR) recommendations.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QT Ultrasound scans | The capabilities of the QT Ultrasound scanner will be measured by the review of the QT Ultrasound scans at the conclusion of each QT Ultrasound scan session | Scan session is 2 to 3 hours |