linjc16/ctgov huggingface dataset:
Standard Telephone Consultation for Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether pain control for patients with chronic pain is improved by the availability of structured telephone consultations between the patients' family physicians and pain physicians, compared to pain control for patients receiving usual care.

Official Title
-----------------
Physician to Physician Telephone Consultation for Chronic Pain Patients: a Pragmatic Randomized Trial

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Behavioral: Physician telephone consultation
* Behavioral: Usual family physician care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients referred to Alberta Health Services chronic pain center in Calgary with neurological or muscular skeletal pain Exclusion Criteria: increased risk for suicide, very complex patients, family physician could not reliably identify patient's pain problem, or condition warranted expedited consultation with pain physician, case represented a new presentation of chronic regional pain syndrome, or low back pain with radicular symptoms or sciatica

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physician telephone consultation<br>Received direct telephone consultation with pain physician about index patient | Behavioral: Physician telephone consultation<br>* Pain physician support for family physician treating patient<br>|
| Active Comparator: Usual family physician care<br>Usual family physician care (without direct telephone consultation with pain physician) | Behavioral: Usual family physician care<br>* Usual family physician care without telephone consultation with pain physician<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Rating Scale for pain intensity (NRS) | 11 point scale (from zero to 10), zero equals no pain, 10 worst possible pain. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Disability Index (PDI) | 7 item self-report scale assessing pain disability | 6 months | 
| Patient Global Impression of Change Scale (PGIC) | 7 point scale | 6 months | 
| Short Form Health Survey (SF-36) | Generic quality of life scale. | 6 months |
Single Incision Versus Conventional Laparoscopic Appendectomy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the short-term outcomes of single-incision and conventional laparoscopic appendectomy.

Detailed Description
-----------------
Appendicitis is the most common abdominal emergency. The treatment is surgical and single incision laparoscopic surgery (SILS) involves performing laparoscopic surgery through a single transumbilical point, in an attempt to improve the results of laparoscopic surgery.

Official Title
-----------------
Prospective Randomised Study Comparing Single Incision Transumbilical Versus Conventional Laparoscopic Appendectomy

Conditions
-----------------
Appendicitis

Intervention / Treatment
-----------------
* Procedure: Single Incision Laparoscopic Appendectomy
* Procedure: Conventional appendectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with suspected acute appendicitis Exclusion Criteria: Perforated appendicitis

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Incision Laparoscopic Appendectomy<br> | Procedure: Single Incision Laparoscopic Appendectomy<br> <br> |
| Experimental: Conventional appendectomy<br>Conventional appendectomy | Procedure: Conventional appendectomy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Improving the Diagnosis of Tonsillitis in Emergency Rooms

Study Overview
=================
Brief Summary
-----------------
A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the diagnosis in less than two hours of tonsillitis caused by known pathogens, close to the reception of Emergency service. In this instance 30% of patients have no etiological diagnosis after the POC tonsillitis tests . This lab has discovered over 200 new species of bacteria in humans, including vector bacteria and opened the field of large Deoxyribonucleic Acid (DNA ) viruses. Also, the laboratory of emerging viruses discovered many Ribonucleic Acid (RNA) viruses transmitted by arthropods. Based on this collection of new pathogens described in POC laboratory, this study proposes to expand the etiological diagnosis strategy of tonsillitis after POC tests. The objective of this study is to implement a new diagnosis strategy relying on the hypothesis that a second pharyngeal swab would improve the etiological diagnosis of tonsillitis of at least 5%.

Conditions
-----------------
Tonsillitis

Intervention / Treatment
-----------------
* Other: Nasopharyngeal swab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient admitted at hospital for tonsillitis requiring, for the emergency physician, a microbiological examination with a POC tonsillitis kit. Patient who has freely signed the informed written consent Patient affiliated to a social security scheme Exclusion Criteria: Pregnant woman, parturient or nursing Adult patient under guardianship Patient deprived of liberty under court order Patient refusing or unable to sign the informed consent form.
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: Patients with clinical diagnosis of tonsillitis<br> | Other: Nasopharyngeal swab<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients admitted for tonsillitis with a confirmed etiological diagnosis of tonsillitis |  | 1 day |
Metabolic Modulation as Treatment in Acute Heart Failure

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate whether metabolic modulation improves hemodynamics and outcome in acute heart failure

Detailed Description
-----------------
Acute heart failure is a serious disease that despite modern therapies carries a high mortality. Inotropic drugs improve patient status but yield a higher risk of death. Previous studies have shown that myocardial contractility improves when glucose fermentation is up regulated and decreases when Free Fatty Acids are high. In a placebo-controlled design we wish to shift myocardial substrate metabolism towards increased glucose uptake and utilization and measure hemodynamics and biochemical markers of metabolism and prognosis.

Official Title
-----------------
Metabolic Modulation as Treatment in Acute Heart Failure

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

Intervention / Treatment
-----------------
* Drug: acipimox


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute heart failure NYHA class III - IV. ejection fraction <35 Exclusion Criteria: Age <18 år or >85 år, allergy renal failure recently developed brady- or tachy-arrythmias Serious infection Heart failure due to restrictive or hypertrophic cardiomyopathy or stenotic valvular heart disease Recent Myocardial infarction (<6 Weeks) Pulmonary Wedge pressure >30 mm Hg diabetes mellitus treated with insulin peptic ulcer pregnancy

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: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac index |  |  | 
| pulmonary Wedge Pressure |  |  | 
| Ejection fraction |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| myocardial glucose- and Free Fatty Acid-extraction |  |  | 
| cardiac output |  |  | 
| Regional left ventricle function |  |  | 
| outcome day 6 and 30 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute heart failure, Metabolic modulation
Dermacyd Silver Floral (Lactic Acid) - Compatibility.

Study Overview
=================
Brief Summary
-----------------
Primary Objective: To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Silver Floral

Official Title
-----------------
Study for Dermatological Evaluation of Topic Compatibility. Primary and Accumulated Dermical Irritability and Dermical Sensitivity for the Product Dermacyd Silver Floral (Lactic Acid).

Conditions
-----------------
Hygiene

Intervention / Treatment
-----------------
* Drug: LACTIC ACID(ND)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Phototype Skin I,II, III e IV Integral skin test in the region Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion Exclusion criteria: Lactation or pregnancy Use of Antiinflammatory 30 days and/or immunossupression drugs for until 3 months before volunteers selection Disease which can cause immunosuppresion, such as diabetes, HIV Use of Antihistamines 30 days before selection Personnel history of atopy History of sensitivity or irritation for topic products Cutaneous active disease (local and/or general) which can modify the study results Use of new drugs and/or cosmetics during the study Cutaneous reaction Previous participation in studies using the same product in test Volunteer which has immunodeficiency congenital or acquired Relevant history or confirmation of alcohol or other drugs abuse Intolerance detected or suspected for some component of the sample tested Medecin or sponsor employees or their close family. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dermacyd Silver Floral (Lactic Acid)<br>Dermacyd Silver Floral (Lactic Acid) sample will be applied like a curative. Physiologic solution and mineral oil will be also used as a control sample. | Drug: LACTIC ACID(ND)<br>* Dermacyd Silver Floral (Lactic Acid) sample will be applied like a curative for 6 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the absence of primary and accumulated dermical irritability and dermical sensitivity by using International Contact Dermatitis Research Group (ICDRG) scale |  | from the treatment start to the end of the study (treatment period 6 weeks) |
HFCS, Apple Juice, Excess Free Fructose & asthma-the FHS-OS

Study Overview
=================
Brief Summary
-----------------
Perform an exploratory analysis of association between consumption of high excess free fructose (EFF) beverages (high fructose corn syrup sweetened soft drinks, fruit drinks, apple juice) and Chronic Bronchitis (CB)/history of CB, and asthma/ history of asthma.

Official Title
-----------------
Moderate Intake of High Fructose Corn Syrup Sweetened Soft Drinks, Fruit Drinks and Apple Juice Increases Asthma Risk - the Framingham Offspring Cohort

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

Intervention / Treatment
-----------------
* Other: Dietary intakes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants in the FHS Offspring who answered questions in the FFQ about soft drinks, fruit drinks and fruit juice consumption; Participants with non-missing data for the exposures and potentially confounding variables of interest. Exclusion Criteria: Extreme energy intake on food frequency questionnaire (defined as ≤600 kcal/day or ≥4800 kcal/day)

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Dietary intakes|Analysis of association between consumption of high excess free fructose (EFF) beverages (high fructose corn syrup sweetened soft drinks, fruit drinks, apple juice)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma | Incident asthma defined as self-reported asthma (at each exam), including wheezing or asthma (have you had asthma/ wheeze since the last exam of short duration, long duration or with respiratory infections) | Exams 3 - 7, 17 years of follow-up |
Acclimatization of Healthy Subjects During a Stay at 3200 m

Study Overview
=================
Brief Summary
-----------------
The study evaluates respiratory acclimatization in healthy lowlanders staying for 3 weeks at 3200 m.

Detailed Description
-----------------
This study evaluates the effect of 3 weeks altitude acclimatization on sleep related breathing disturbances in healthy subjects staying at 3200 m. Participants living in Bishkek, Kyrgyzstan (700 m), will be transferred by car within 4 h to the Tuja Ashu high altitude clinic (3200 m). Outcomes will be assessed repeatedly during the stay at 3200 m.

Official Title
-----------------
Acclimatization of Healthy Subjects During a Stay at 3200 m

Conditions
-----------------
Effects of High Altitude

Intervention / Treatment
-----------------
* Other: Altitude exposure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Perfect health Born, raised and currently living at low altitude (<800m) Informed consent. Exclusion Criteria: Any acute or chronic disease heavy smoking (>20 cigarettes per day).

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Altitude exposure<br>Stay at 3200 m for 3 weeks | Other: Altitude exposure<br>* Participants will stay for 3 weeks at an altitude of 3200 m<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean nocturnal oxygen saturation measured by pulse oximetry | Difference in mean nocturnal oxygen saturation between night 1 and night 7 | night 7 at 3200 m | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean nocturnal oxygen saturation measured by pulse oximetry | Difference in mean nocturnal oxygen saturation between night 1 at 3200 and night 1 at 700 m | night 1 at 3200 m | 
| Mean nocturnal oxygen saturation measured by pulse oximetry | Difference in mean nocturnal oxygen saturation between night 21 and night 1 at 3200 m | night 21 at 3200 m | 
| Mean nocturnal oxygen saturation measured by pulse oximetry | Mean nocturnal oxygen saturation during night 1 at 700 m | night 1 at 700 m (low altitude baseline) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sleep, healthy volunteers, acclimatization, hypoxia
MD Ezetimibe Cyclosporine Interaction (0653-057)

Study Overview
=================
Brief Summary
-----------------
Study to determine the effect of multiple oral doses of ezetimibe on the pharmacokinetics of a single oral dose cyclosporine in young healthy males and females.

Official Title
-----------------
An Open-Label, 2-Period, Crossover Study to Determine the Effect of Multiple Oral Doses of Ezetimibe 20 mg on the Pharmacokinetics of a Single Oral Dose of Cyclosporine in Young, Healthy, Normal, Male and Female Subjects

Conditions
-----------------
Cholesterol

Intervention / Treatment
-----------------
* Drug: ezetimibe
* Drug: Comparator: cyclosporine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is male or female between 18 to 45 years of age Subject is judged to be in good health on the basis of history, physical examination, and routine laboratory data Exclusion Criteria: Premenopausal women who are currently pregnant or who are currently nursing Subjects with drug or substance abuse, poor mental function, history of major gastrointestinal abnormalities (stomach issues), or high cholesterol Subject that has donated blood or has participated in another clinical trial within the last four weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment A<br>Treatment A: subjects will be given a single oral dose of cyclosporine 100 mg capsules on Day 1. | Drug: Comparator: cyclosporine<br>* single oral dose of cyclosporine 100 mg capsules on Day 1 or Day 7.<br>|
| Active Comparator: Treatment B<br>Treatment B: subjects will receive single oral daily doses of ezetimibe 20 mg (2 x 10 mg tablets) on Days 1 through 6, followed by coadministration of a single oral dose of ezetimibe 20 mg (2 x 10 mg tablets) and cyclosporine 100 mg capsule on Day 7. | Drug: ezetimibe<br>* ezetimibe 20 mg (2 x 10 mg tablets) on Days 1 through Day 7.<br>* Other names: Zetia®;Drug: Comparator: cyclosporine<br>* single oral dose of cyclosporine 100 mg capsules on Day 1 or Day 7.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of cyclosporine coadministered with ezetimibe vs. cyclosporine administered alone. |  | Blood sampling will be conducted for 48 hours starting with the first cyclosporine dosing. |
Factors Associated With Hyponatremia Induced by High-dose Cyclophosphamide

Study Overview
=================
Brief Summary
-----------------
Prospoctive cohort of high-dose cyclophosphamide exposed patients. With active estandardize screening of hyponatremia development in the follow up period.

Detailed Description
-----------------
Primary objectives To identify the factors associated with the development of hyponatremia in patients receiving high-dose cyclophosphamide (2.5 grams or more). Generate and validate a predictive score of developing hyponatremia high-dose cyclophosphamide. To estimate the incidence of hyponatremia in patients undergoing high-dose cyclophosphamide. Study design. Observational prospective cohort study of Patients after infusion of high-dose cyclophosphamide. Follow up period will be from cyclophosphamide infusion until one month after hospital discharge.

Official Title
-----------------
Factors Associated With Hyponatremia Induced by High-dose Cyclophosphamide: Prospective Cohort Study

Conditions
-----------------
Hyponatremia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (over 18 years) who were admitted to the Hematology / Oncology and Medical Clinic Hospital Italiano de Buenos Aires infusion of high-dose cyclophosphamide for conducting MSCH prior BMT, GATLA and HyperCVAD in the period 2015-2017. Exclusion Criteria: Refusal to participate or to the process of informed consent.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High-dose Cyclophosphamide<br>Patients requiring infusion of high-dose cyclophosphamide in the period 2015-2017 will be included. After informed consent, patients will de follow up from the infusion of cyclophosphamide to 30 days after hospital discharge. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hyponatremia | Hyponatremia, measured as any value sodium after infusion and defined as positive if sodium less than 135 mEq / l (Yes / No, dichotomous categorical variable). For the incidence of hyponatremia is only included in the calculation hionatremia patients with normal sodium before infusion. | Between 6 and 8 hours after the infusion of cyclophosphamide is performed. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug induced Hyponatremia, Cyclophosphamide, Hyponatremia, Cyclophosphamide induced Hyponatremia