linjc16/ctgov huggingface dataset:
Massage for Low Back Pain in Nursing Staff

Study Overview
=================
Brief Summary
-----------------
Objectives: Semi experimental Clinical Trial aimed at verifying the effectiveness of massage for lower back pain occupational as well as to assess the influence of technique in performing work activities and life in the team nursing.

Detailed Description
-----------------
Method: 18 officials received 7-8 massage sessions, twice per week, with the same protocol points. Data were collected on baseline, after one and two months and they responded 2 questionnaires (Functional Assessment of Oswestry and Risk Assessment in Movement and Transfer Scale) and the Numeric Pain Scale.

Official Title
-----------------
Application of Massage for Low Back Pain in Nursing Staff

Conditions
-----------------
Low Back Pain

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Voluntary participation in the study of employees with availability of time for submission to the sessions Not be pregnant Hold shift of at least 6 hours daily Do not go on vacation or leave care during the study period Reporting back pain self-reported or confirmed by medical diagnosis Not having passed off due to back pain in past 6 months Do not submit spondylolisthesis, disc herniation and sciatic pain self-reported or confirmed by medical diagnosis Do not use anti-inflammatory drugs Individuals that showed greater than 0 (zero) in the Numerical Pain Scale (10) Score higher than 15 on the Functional Assessment Questionnaire Oswestry Exclusion Criteria: Employees who left the study or that lost more than one session

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 58 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: massage<br>The massage Anma has Japanese origin and a protocol was used with smoothing, kneading and pressure points on the bladder meridian. | Other: Massage<br>* Massage Anmá: 7-8 sessions, twice per week, kneading and pressure points on the bladder meridian<br>* Other names: Acupressure;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Application of Massage for Low Back Pain in Nursing Staff | Effectiveness of massage in alleviating lower back pain through response to 2 questionnaires (Functional Assessment of Oswestry and Risk Assessment in Movement and Transfer Scale) and the Numeric Pain Scale. | two months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Low back Pain
Keloid Scarring: Treatment and Pathophysiology

Study Overview
=================
Brief Summary
-----------------
To clarify the mechanisms of Keloid scar formation. Elucidate the action and therapeutic value of 5-FU in Keloid scar treatment Identify the genetic link with Keloid scar formation. Quantify the psychological/social impact in keloid scarring patients

Official Title
-----------------
Keloid Scarring:A Randomized Clinical and Laboratory Based Study on the Treatment and Differentiation Factors of the Local Disease

Conditions
-----------------
Keloid Scar

Intervention / Treatment
-----------------
* Drug: 5- fluorouracil
* Radiation: radiotherapy
* Drug: Triamcinolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult ( > 18 years old). Keloid scarring present. Able to understand and give informed consent. Patients giving informed consent to donate keloidal or non-affected skin when that is redundant after a procedure (i.e. BBR, Abdominoplasty). Patients with a strong familial pedigree of keloid scar formation. Exclusion Criteria: Open wound at or proximity of the lesion Infected lesion Pregnant or planning pregnancy in the near future Lactating (Breast Feeding) Abnormal renal or liver function tests Atrophic scars Patient under 18 years of age Immunocompromised OR immunosuppressed

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 5-Fluorouracil<br>Patients with small keloidal scars to have intralesional 5FU injected | Drug: 5- fluorouracil<br>* 5mg of 5FU injected per 1cm square, at 6 week intervals for 30 weeks = 6 sessions<br>|
| Active Comparator: Radiotherapy<br>Large keloid scars undergo extralesional excision and radiotherapy | Radiation: radiotherapy<br>* after complete excision of keloid they have a single session of radiotherapy<br>|
| Active Comparator: TAC<br> | Drug: Triamcinolone<br>* TAC 10mg in 1ml injected intralesional<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Keloid Scar Reduction | Using a 3D scanner to observe the reduction of the scar volume measured in cubic centimetres | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
scar formation, 5-FU, genetic link, psychological impact, social impact
Validation of a Correction Factor for Measurement of an Accurate Ankle-Brachial Index in the Seated Position

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test a correction factor which would allow ankle brachial indexes taken in the seated position to accurately predict an ankle brachial index taken in the supine position.

Detailed Description
-----------------
Peripheral arterial disease (PAD) is a highly prevalent medical condition. Patients with PAD are usually diagnosed on the basis of a simple diagnostic procedure know as the ankle-brachial index (ABI). The ABI is the ratio of ankle pressure to arm pressure after measurement of blood pressures in the arms and legs using a hand-held Doppler device. In order for the ABI measurement to be accurate, the test is conducted with the patient in the supine position. This eliminates the influence of hydrostatic pressure on the ankle and toes which can lead to a falsely elevated reading. Unfortunately, many patients are unable to lie supine for ABI measurement, including: the wheel-chair bound, patients with degenerative disease of the spine or arthritis with chronic back pain, and patients with advanced cardiopulmonary disease and orthopnea. Given the importance of detecting PAD across a broad spectrum of patients, there is a need to identify a mechanism for reliable measurement of the ABI for patients who cannot lie supine. The purpose of this study is to test a correction factor for the effects of hydrostatic pressure on the lower extremities to allow for accurate ABI calculation in the seated position. 100 Subjects with suspected arterial disease in the vascular lab will be enrolled. Arm, ankle, and toe pressure measurements will be made in the supine and seated positions. The seated ankle pressures will be corrected for hydrostatic pressure using a mechanical formula. The ABI and toe brachial index (TBI) will be calculated.

Official Title
-----------------
Validation of a Correction Factor for Measurement of an Accurate Ankle-Brachial Index in the Seated Position

Conditions
-----------------
Peripheral Arterial Disease

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Patient at least 60 years of age Ambulatory outpatient Referred to non-invasive Vascular Laboratory for evaluation of suspected arterial disease. Exclusion Criteria: Unable to give informed consent Unable to lie supine for at least 15 minutes

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
peripheral arterial disease, pad, ankle brachial index, abi
Predicting Cardiometabolic Risk in Mild-to-Moderate Obstructive Sleep Apnea: Inflammation vs. Apnea/Hypopnea Index

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare the relative contribution of systemic inflammation vs. Obstructive Sleep Apnea (OSA) severity (as measured by Apnea Hypopnea Index) in predicting cardiovascular and metabolic aberrations associated with mild-to-moderate obstructive sleep apnea.

Official Title
-----------------
Predicting Cardiometabolic Risk in Mild-to-Moderate Obstructive Sleep Apnea: Inflammation vs. Apnea/Hypopnea Index

Conditions
-----------------
Obstructive Sleep Apnea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mild to moderate OSA (5≤ AHI <30) BMI ≤ 45 Age ≥ 18 Men & Women Exclusion Criteria: AHI ≥ 30 BMI >45 Current use of steroids or anti-inflammatory medication Diagnosis of insulin dependent diabetes Diagnosis of autoimmune disorder Shiftwork Current use of CPAP

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 |
| --- | --- | --- |
| Presence of the metabolic syndrome | At least 3 of the following 5 risk factors must be met in order to have the metabolic syndrome: Elevated waist measurement (≥102 cm for men or ≥89 cm for women) Elevated triglycerides (≥150 mg/dL or use of medication) Low HDL cholesterol (<50 mg/dL for women or <40 mg/dL for men or use of medication) Elevated blood pressure (≥130 mmHg systolic or ≥ 85 mmHg diastolic or use of medication) Elevated fasting blood sugar (≥100 mg/dL or use of medication) Source: https://www.nhlbi.nih.gov/health/health-topics/topics/ms | baseline | 
| Obstructive Sleep Apnea | AHI from one night polysomnography | baseline | 
| Markers of systemic inflammation | CRP, IL-6, TNFa | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability | from polysomnography | baseline | 
| Subjective measure of sleepiness | Epworth Sleepiness Scale | baseline |
Observational Study Comparing Gastric Calibration Tubes

Study Overview
=================
Brief Summary
-----------------
Observational study comparing thin pvc with thick silicone gastric calibration tube for bariatric surgery. Most of the times a thin gastric tube is used. Sometimes insertion is difficult due to kinking, resistance, bulging and not advancing in the right spot requiring re introduction, help from a colleague, or change to the thick silicone type. When tube is changed during insertion to the silicone type the method insertion is compared with the previous approach.

Detailed Description
-----------------
Observational study comparing thin pvc with thick silicone gastric calibration tube for bariatric surgery. Most of the times a thin gastric tube is used. Sometimes insertion is difficult due to kinking, resistance, bulging and not advancing in the right spot requiring re introduction, help from a colleague, or change to the thick silicone type. When tube is changed during insertion to the silicone type the method insertion is compared with the previous approach. A note is made of the problem encountered, how long it took to place it correctly ( time from insertion till first staple), what was done to solve the problem, if a new identical tube was used or another and what type was used. If another tube how log did it take to get first stapler done. some demographic and procedure information is recorded: gender, age, BMI, procedure planned, first bariatric procedure or second after ...

Official Title
-----------------
Observational Study Comparing Thin Pvc With Thick Silicone Gastric Calibration Tube for Bariatric Surgery

Conditions
-----------------
Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: bariatric surgery being sleeve gastrectomy, gastric bypass or conversion procedure. Exclusion Criteria: pre existing esophageal disease making use of gastric tube contra indicated, difficult or impossible.

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 |
| --- | --- | --- |
| need to change gastric tube | rate of changing gastric tube | intraoperative | 
| introduction time | time from start insertion till first staple in minutes | intraoperative |
Hemodynamic Effects of Rolofylline in the Treatment of Patients With Heart Failure (7418-503)

Study Overview
=================
Brief Summary
-----------------
The study will estimate the effects of rolofylline, alone and in addition to loop diuretic therapy on pulmonary capillary wedge pressure and other hemodynamic parameters, in patients with heart failure and renal impairment.

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Hemodynamic Effects of Rolofylline Injectable Emulsion in the Treatment of Patients With Heart Failure

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Drug: Comparator: Placebo
* Drug: rolofylline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with heart failure and renal impairment, currently using furosemide, with systolic blood pressure >95 mm Hg Exclusion Criteria: Patient has active infection, use of diuretic within 3 hours of screening visit, has acute tubular necrosis or severe pulmonary disease, any heart problems within the last two weeks

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 |
| --- | --- |
| Placebo Comparator: 1<br>Placebo | Drug: Comparator: Placebo<br>* rolofylline placebo IV infusion over 4 hours.<br>|
| Experimental: 2<br>rolofylline | Drug: rolofylline<br>* rolofylline 30 mg IV infusion over 4 hours.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in pulmonary capillary wedge pressure |  | from baseline to 4 and 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cardiac output, systemic vascular resistance, pulmonary vascular resistance, pulmonary pressure and right atrial pressure |  | from baseline to 4 and 8 hours |
BF2.649 in Patients With OSA and Treated by CPAP But Still Complaining of EDS

Study Overview
=================
Brief Summary
-----------------
Multicenter randomized double blind study versus placebo during 12 weeks with at first, an escalating dose period followed by stable dose period at the selected dose. This double-blind period can be followed by a 9 months open-label period if the patient wishes to continue with the study product.

Detailed Description
-----------------
The first period (12 weeks double blind period) will aim at demonstrating the efficacy and safety of BF2.649 by verifying whether the results of BF2.649 are superior to those of placebo. The aim of the second period (open label extension phase) will be to assess the long-term tolerance, as well as the maintenance of the BF2.649 efficacy.

Official Title
-----------------
BF2.649 in Patients With Obstructive Sleep Apnea Syndrome (OSA) and Treated by Nasal Continuous Positive Airway Pressure (nCPAP), But Still Complaining of Excessive Daytime Sleepiness (EDS)

Conditions
-----------------
Obstructive Sleep Apnea, Excessive Daytime Sleepiness

Intervention / Treatment
-----------------
* Drug: BF2.649
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with OSA treated by nCPAP but still complaining with EDS ESS score > or = 12 Exclusion Criteria: patient suffering from insomnia without OSA co-existing narcolepsy patient with sleep debt not due to OSA acute or chronic severe disease

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BF2.649<br>BF2.649 capsules dosed at 5mg, 10 mg, 20mg | Drug: BF2.649<br>* 1 capsule in the morning before breakfast<br>* Other names: Pitolisant;|
| Placebo Comparator: Placebo<br>Capsules of Placebo containing lactose with low, medium and high dosage | Drug: Placebo<br>* 1 capsule in the morning before breakfast<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ESS change (Epworth Sleepiness Scale) |  | at week 12 /52 versus baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep disorder, obstructive sleep apnea, excessive daytime sleepiness, patients with OSA treated by CPAP presenting EDS
Study Evaluating the Effect of IMA-026 on Allergen-Induced Late Asthma Response in Mild Asthma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of IMA-026, an antibody to IL-13, on airway hyperresponsiveness and airway inflammation in mild asthmatics. IMA-026 will be given as 2 injections under the skin 1 week apart at 2 mg/kg each dose. The study will include a screening period and a treatment period which includes doses on day 1 and day 8.

Official Title
-----------------
The Effects of IMA-026 on Allergen-Induced Airway Responses and Airway Inflammation in Subjects With Mild Atopic Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: IMA-026
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men and women 18 to 60 yrs with mild allergic asthma only asthma med is short-acting bronchodilator used not more than twice weekly FEV1 greater than 70% predicted and a demonstrated baseline late response to allergen induction Exclusion Criteria: Upper respiratory infection or asthma exacerbation with 4 weeks of screening Serious infection requiring parenteral antibiotics or hospitalization with 4 weeks of test article administration Positive radiographic findings indicative of respiratory disease other than asthma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: IMA-026<br> <br> |
| Placebo Comparator: B<br> | Other: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the maximum change in FEV1 from baseline for the LAR between IMA-026 and placebo |  | 11 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment comparison of the hour 3 and hour 7 FEV1 AUC for the LAR; various comparisons of the methacholine PC20 |  | 11 weeks |
Pharmacokinetics of Off Label Pediatric Medications

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure the level of medicines found in body fluids such as blood, urine, spinal fluid of children.

Detailed Description
-----------------
There is a lack of safety, pharmacokinetic and efficacy data of therapeutic agents in children and infants. Samples used for measurement will be from scavenged samples. i.e. any extra blood/body fluid samples from a test done as part of the standard of care.

Official Title
-----------------
Pharmacokinetics of Off Label Pediatric Medications

Conditions
-----------------
Off Label Use of Medications in Pediatric Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children less than 8 years of age Receiving a therapeutic agent at a dose or for an indication not currently included on the FDA label as part of standard of care Exclusion Criteria: Lack of consent

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 8 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 |
| --- | --- | --- |
| Area under the curve (AUC) | actual body exposure to drug after a dose of the drug is administered. this is dependent on on the rate of drug elimination divided by plasma concentration of the drug. | approximately 10-21 days.The time frame for the outcome measure may vary depending on the length of the course of the medication. | 
| Volume of distribution at steady-state | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steady-state. | approximately 10-21 days. The time frame for the outcome measure may vary depending on the length of the course of the medication. | 
| Terminal elimination rate constant (Ke) and Half-Life | Period of time that it takes for the concentration of the drug in the body to be reduced by on-half. | approximately 10-21 days. The time frame for the outcome measure may vary depending on the length of the course of the medication. | 
| Plasma Clearance | the rate at which the drug is eliminated from the body divided by the plasma concentration. | approximately 10-21 days. The time frame for the outcome measure may vary depending on the length of the course of the medication. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmacokinetics