linjc16/ctgov huggingface dataset:
Avdoralimab an Anti-C5aR Antibody, in Patients With COVID-19 Severe Pneumonia ( FORCE )

Study Overview
=================
Brief Summary
-----------------
The primary objective of this trial is to improve the proportion of COVID-19 patients with severe pneumonia who no longer need to be hospitalized, and to reduce the need for and duration of mechanical ventilation in patients with COVID-19 pneumonia complicated by acute respiratory distress syndrome (ARDS).

Official Title
-----------------
A Double-blind, Randomized Study Versus Placebo of Avdoralimab (IPH5401), an Anti-C5aR Antibody, in Patients With COVID-19 Severe Pneumonia

Conditions
-----------------
COVID

Intervention / Treatment
-----------------
* Biological: avdoralimab
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COVID-19 severe pneumonia patients need for oxygen therapy ≥ 5 l/min or high-flow oxygen therapy COVID-19 related Acute Respiratory Distress Syndrome (ARDS) requiring mechanical ventilation Exclusion Criteria: Pregnant woman Uncontrolled sepsis of bacterial or fungal origin

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: avdoralimab<br>Biological/Vaccine: avdoralimab intravenous administration of avdoralimab Other Names: • IPH5401 | Biological: avdoralimab<br>* intravenous administration of avdoralimab<br>* Other names: IPH5401;|
| Placebo Comparator: Placebo<br>intravenous administration of Placebo | Other: Placebo<br>* intravenous administration of placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement using WHO ordinal scale | improvement of WHO ordinal scale | day 28 | 
| Number of ventilator-free days at Day 28 (VFD28) | Number of days without mechanical ventilation at Day 28 for COVID-19 related Acute Respiratory Distress Syndrome (ARDS) Patients hospitalized in ICU | day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events |  | day 28 |
Predictive Factors for Postoperative Pain, Nausea and Vomiting in Oncological Patients

Study Overview
=================
Brief Summary
-----------------
1809 patients were evaluated in postoperative period. They were asked about nausea, vomiting, retching and pain in the first postoperative 24 hours

Detailed Description
-----------------
Patients were prospectively evaluated , and nausea, vomiting and pain were recorded.

Official Title
-----------------
Evaluation of Predictive Factors for Nausea, Vomiting and Postoperative Acute Pain in Oncological Patients

Conditions
-----------------
Nausea, Vomiting, Pain, Postoperative

Intervention / Treatment
-----------------
* Procedure: Analgesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients submitted to oncological surgeries Exclusion Criteria: refusal to sign the agreement term lack of information in the records

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Analgesia|Patients will be observed during postoperative period,|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of postoperative pain | pain intensity was measured using descriptive and verbal number scale | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| side effects from analgesia | nausea, vomiting, pruritus and hypotension were measured during first 24 postoperative hours | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nausea, vomiting, pain
The Effect of Patient Cost-Sharing on Antidepressant and Adjunctive Therapy Use

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to measure the effects of patient cost-sharing on the initiation of adjunctive treatment and subsequent healthcare utilization and expenditures among a population of commercially insured adults on antidepressant therapy.

Official Title
-----------------
The Effect of Patient Cost-Sharing on Antidepressant and Adjunctive Therapy Use

Conditions
-----------------
Depressive Disorder, Major

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (aged 18-64) will be selected from the MarketScan Commercial Database between January 1, 2004, and September 30, 2008, if they have at least two medical claims with a diagnosis of depression and at least one prescription fill for an antidepressant medication. Exclusion Criteria: Patients who have any claim with a diagnosis of dementia, schizophrenia, delusional disorder, psychoses, pervasive development disorder, mental retardation, cerebral degenerations, Parkinson's disease, senility, manic depression, bipolar disorder, or major depressive disorder with psychotic symptoms.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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 |
| --- | --- |
| depression & initial prescription for an antidepressant<br>A sample of adults with a diagnosis of depression and an initial prescription fill for an antidepressant | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome is any use of adjunctive treatment (combined and by class) and the time to initiation of adjunctive treatment (combined and by class). | 16 months of medical and prescription drug coverage after the initial antidepressant prescription claim | 16 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity to cost-sharing will be examined as a function of treatment resistance | 16 months of medical and prescription drug coverage after the initial antidepressant prescription claim | 16 months |
Compliance and Efficacy in the Use of PICOPREP®

Study Overview
=================
Brief Summary
-----------------
The present trial is aimed to document efficacy (bowel cleanliness), acceptance and tolerability as well as patient comfort in the use of the new bowel cleansing product PICOPREP® in every day practice. In particular, it should be evaluated, whether bowel cleanliness, acceptance, tolerability and patient comfort are affected by specific practice procedures, changes in dose etc.

Official Title
-----------------
Compliance and Efficacy in the Use of PICOPREP® for Bowel Cleansing

Conditions
-----------------
Bowel Cleanliness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving PICOPREP® for bowel evacuation prior to endoscopy or surgery Patients who have been informed about the NIS and have given their written consent for participation Exclusion Criteria: Patients in which prescription of PICOPREP® is contraindicated

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documentation of the use of PICOPREP® in every day practice | Will evaluate efficacy (bowel cleanliness), compliance, acceptance, tolerability and patient comfort | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documentation of patient satisfaction after bowel cleansing |  | 2 days | 
| Documentation of examiner satisfaction after colonoscopy |  | 2 days | 
| Identification of patient groups in which bowel cleansing is more difficult due to concomitant diseases or other conditions (risk groups) |  | 2 days | 
| Tolerability: frequency and severity of adverse events |  | 2 days |
Feasibility of Mutational Analysis of Non-Small Cell Lung Cancer (NSCLC) Using Low-volume Lung Aspirates

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the feasibility of aspiration samples for mutational analysis in patients with a non-small cell lung cancer (NSCLC).

Detailed Description
-----------------
The investigators will compare results of mutational analysis from a core needle biopsy and fine needle aspiration.

Official Title
-----------------
Feasibility of Gene Expression Profiling Using Low-volume Lung Aspirate

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Procedure: biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary tumor or a metastatic lung lesion requested for mutational analysis Exclusion Criteria: a) lesions located adjacent to the large central bronchi or vessels b) peribronchovascular lesions with prominent internal CT air-bronchograms, which were considered difficult to be avoided by needle pass c) lesions in patient with severe respiratory compromise

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Gene profiling Success<br> | Procedure: biopsy<br>* percutaneous lung biopsy and aspiration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rates for mutation analysis |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success rate of biopsy procedure |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biopsy, needle aspiration, mutational analysis
Effect of Massage on Hamstring Muscle Soreness

Study Overview
=================
Brief Summary
-----------------
Delayed onset muscular soreness peaks in 24-48 hours after unaccustomed strenuous physical exercise. Therapists often provide manual massage with the hands to acutely relief the soreness. Alternatives to manual hand massage can be useful for therapists. Here the investigators examine the acute effect of a massage roller on DOMS in the hamstring muscles

Official Title
-----------------
Danish: Integreret Motion på Arbejdspladsen (IRMA) English: Implementation of Exercise at the Workplace

Conditions
-----------------
Musculoskeletal Disorders

Intervention / Treatment
-----------------
* Other: Massage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: working age adults Exclusion Criteria: blood pressure above 160/100 disease of the cervical spine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 67 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Control group, does not receive any intervention | |
| Experimental: Massage group<br>Massage will be performed on the left or right hamstring muscle (randomized) for ten minutes with a massage roller. The contralateral leg will not be massaged, but serve as a non-massaged control leg to assess possible cross-over effects from the massaged leg | Other: Massage<br>* The hamstring muscle will be massaged with a massage roller for ten minutes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived soreness on a scale of 0-10 | 0: no soreness 10: worst imaginable soreness | change from before to after massage (average of 0, 10, 30 and 60 min after) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure pain threshold (PPT) of the hamstring muscles |  | change from before to after massage (average of 0, 10, 30 and 60 min after) | 
| Hamstring range of motion |  | change from before to after massage (average of 0, 10, 30 and 60 min after) |
BPM Cuff： 15-24cm, 20-34cm, 30-44cm, 40-48cm, 22-42cm

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to verify the accuracy of the 5 blood pressure cuffs, with blood pressure monitor device. The cuff range is as follows: 15cm-24cm, 20cm-34cm, 30cm-44cm, 40cm-48cm, and 22cm-42cm

Conditions
-----------------
Blood Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal adult or adults with Hypertension Exclusion Criteria: ⎯1) people with serious arrhythmia Patients with Takayasu arteritis people wit adverse vascular peripheral circulation people with upper limbs vein thrombosis people who is weak

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 83 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 |
| --- | --- |
| Arm Automatic Electronic BPM<br> | |
| mercury sphygmomanometer<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All the test results of the electronic blood pressure monitor with 5 cuffs is within the accuracy creteria, with the mercury sphygmomanometer as control |  | 1 day |
Thoracic Manipulation in Patients With Cervical Radiculopathy

Study Overview
=================
Brief Summary
-----------------
Hypothesis: The group of Cervical Radiculopathy patients receiving thoracic thrust manipulation will demonstrate immediate and short term significant clinically important changes in outcomes when compared to the sham manipulation group.

Official Title
-----------------
Immediate and Short Term Effects of Thoracic Manipulation in Patients With Cervical Radiculopathy

Conditions
-----------------
Cervical Radiculopathy

Intervention / Treatment
-----------------
* Procedure: Thrust Manipulation - Thoracic Spine
* Procedure: Sham Manipulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-65 yrs 3 out 4 Items positive of Clinical Prediction Rule for Cervical Radiculopathy Exclusion Criteria: history of previous cervical or thoracic spine surgery bilateral upper-extremity symptoms, signs or symptoms of upper motor neuron disease, medical red flags (e.g., tumor, fracture, rheumatoid arthritis, osteoporosis, and prolonged steroid use).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Thrust Manipulation -Thoracic Spine<br>Mid and Upper Thoracic Spine | Procedure: Thrust Manipulation - Thoracic Spine<br>* Mid and Upper Thoracic Spine<br>|
| Placebo Comparator: Sham Manipulation<br>Mid and Upper Thoracic Spine | Procedure: Sham Manipulation<br>* Mid and Upper Thoracic Spine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Rating of Change | Perceived Improvement | Pre Treat, Immed, 48-72 hours | 
| Numeric Pain Rating Scale (Neck & Upper Extremity) | Pain | Pre Treat, Immed, 48-72 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck Disability Index | Disability | Pre Treat, Initial, 48-72 hours. | 
| Cervical Range of Motion |  | Pre-treat, immediate post, 48-72 hours | 
| Deep Neck Flexor Endurance |  | Pre Treat, Immed, 48-72 hours | 
| Numbness and Tingling Scale | Rating of distal paresthesia/numbness | Pre Treat, Immed, 48-72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cervical Radiculopathy, Neck Pain, Manipulation
PET-MR-PSA Prostate Cancer Recidive Study

Study Overview
=================
Brief Summary
-----------------
Simultaneous PET/MRI has the potential to improve the detection accuracy in recurrent prostate cancer, since it combines the excellent soft-tissue contrast of MRI with the high molecular sensitivity of PET in a single imaging session. The aim of this study is to evaluate the sensitivity and specificity of simultaneous 18F-Fluciclovine PET/MRI for detection of recurrent prostate cancer.

Detailed Description
-----------------
The patients follow standard treatment and follow-up after the PET/MRI exam, which will be determined by the patient's treating urologist and/or oncologist. Data from histopathology, clinical follow-up and follow-up imaging will be collected to establish a reference standard that defines the presence or absence of disease for each patient. The imaging findings will be compared with the reference standard to assess the sensitivity and specificity. The diagnostic accuracy of combined PET/MRI and MRI-only (the current clinical standard) will be compared.

Official Title
-----------------
18F-Fluciclovine PET/MRI for Detection of Recurrent Prostate Cancer After Radical Treatment

Conditions
-----------------
Prostate Cancer Recurrent

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the criteria for biochemical relapse in accordance with the European Association of Urology (EAU) guidelines on prostate cancer must be fulfilled (two consecutive measurements with PSA > 0.2 ng/ml following radical prostatectomy or PSA > 2.0 ng/ml above the nadir following definitive radiotherapy) potential candidates for salvage treatment based on age and co-morbidity. Exclusion Criteria: general contra-indications for a PET/MRI exam (pacemaker, aneurysm clips, any form of metal in the body, or severe claustrophobia) impaired renal function defined as estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2

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

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
| Detection of recurrent prostate cancer by simultaneous 18F-Fluciclovine PET/MRI. | Relevant patient information will be collected until 2027, 10 years after the last PET/MRI scan. | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PET-MR, recidive, PET/MR imaging, 18F-Fluciclovine, radical treatment, recurrence
Promoting Clinical Preventive Services Among Adults With Disabilities

Study Overview
=================
Brief Summary
-----------------
Project SHIELD (Strategies and health Interventions to Enhance Life with Disability) is a participatory action research project to test an intervention package combining a resource kit with peer mentoring in improving consumer education about primary preventive services

Detailed Description
-----------------
Adults with disabilities use primary preventive health care services (basic screenings, immunizations, and hevior health counseling) at rates below those recommended by the US Preventive Services Task Force and Healthy People 2010. This projects is to carry out a community-based campaign to increase preventive care knowledge and service use among adults with physical disabilities. Focus group methodology will be used to determine the specific preventive service priorities of the disability community so that targeted resource materials for consumers and physicians can be developed. Second, a randomized control group experiment will be implemented to evaluate the effectiveness of the targeted resource materials, followed by dissemination of the Preventive Services Resource Kits.

Official Title
-----------------
Promoting Prevention Among Adults With Disabilities

Conditions
-----------------
Physical Disability

Intervention / Treatment
-----------------
* Behavioral: Preventive Services Prevention Kit
* Behavioral: peer mentors (control group)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary residence in Northern Virginia presence of a physical disability at least 18 years old Exclusion Criteria: -

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Preventive Services Prevention Kit|nan|
|Behavioral: peer mentors (control group)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention-related knowledge and beliefs |  |  | 
| Self-efficacy |  |  | 
| Service-seeking intent |  |  | 
| Service utilization |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perceptions of the Preventive Service Resource Kit |  |  |