linjc16/ctgov huggingface dataset:
Quality of Life in Asthma and Rhinitis Allergic With Singulair (0476-365)

Study Overview
=================
Brief Summary
-----------------
Allow physicians not familiar with anti-leukotriene based therapy to test it

Official Title
-----------------
Quality of Life in Asthma and Rhinitis Allergic With Singulair

Conditions
-----------------
Asthma, Rhinitis Allergic

Intervention / Treatment
-----------------
* Drug: MK0476, Singulair, montelukast sodium / Duration of Treatment: 8 Weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Establish diagnosis of mild to moderate chronic asthma and/or allergic rhinitis currently on treatment Voluntary acceptance to participate in the study Exclusion Criteria: Patients with cystic fibrosis Patients with known hypersensitivity to singulair or any of its components Patients with severe chronic asthma

Ages Eligible for Study
-----------------
Minimum Age: 6 Years

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

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

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: MK0476, Singulair, montelukast sodium / Duration of Treatment: 8 Weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life measures |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nocturnal wake up, work or school absences, physical activity and recurrence of asthma and/or rhinitis |  |  |
An Evaluation of the Effect of the Erchonia Corporation Violet Zerona® Z6 for Body Contouring

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical study is to determine the effectiveness of the Erchonia® Violet Zerona Z6 (manufactured by Erchonia Corporation (the Company), an over-the-counter (OTC) laser device, in providing noninvasive body circumference reduction.

Detailed Description
-----------------
The clinical study is an open-label non-inferiority design to evaluate the efficacy of the Erchonia® Violet Zerona Z6, an over-the-counter (OTC) laser device, in providing noninvasive circumference reduction. The clinical study protocol is based on the protocol for the clinical study whose results were submitted in support of clearance of the predicate device, the Erchonia® Zerona® Z6 OTC.

Official Title
-----------------
An Evaluation of the Effect of the Erchonia Corporation Violet Zerona® Z6 for Body Contouring

Conditions
-----------------
Circumference Reduction

Intervention / Treatment
-----------------
* Device: Erchonia Violet Zerona Z6


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI is 30 or less 18 years of age or older Exclusion Criteria: Pregnant Open wounds (sores, cuts, ulcers, etc.) Individuals with or being treated for any cancerous growth

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erchonia Violet Zerona Z6<br>405nm violet laser light therapy. | Device: Erchonia Violet Zerona Z6<br>* 405nm violet diode low level laser device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined Circumference Reduction in Inches of the Waist, Hips, and Bilateral Thighs | Mean change in total combined circumference inches of the waist, hips and bilateral thighs from baseline to endpoint evaluation. | 2 weeks |
Measurement of Cerebral Oxygen Extraction Fraction Using MRI Technique

Study Overview
=================
Brief Summary
-----------------
All images in this study were acquired on a 1.5 T Sonata whole body scanner (Siemens Medical Inc., Erlangen, Germany) using 2D multi-echo gradient echo/spin echo sequence and 2D single-shot gradient echo-planar imaging sequence plus intravenous magnetic susceptibility contrast medium. The quantitative estimates and mapping of cerebral metabolic rate of oxygen utilization were calculated and plotted in all subjects.

Detailed Description
-----------------
All images in this study were acquired on a 1.5 T Sonata whole body scanner (Siemens Medical Inc., Erlangen, Germany) using 2D multi-echo gradient echo/spin echo sequence and 2D single-shot gradient echo-planar imaging sequence plus intravenous magnetic susceptibility contrast medium. The quantitative estimates and mapping of cerebral metabolic rate of oxygen utilization were calculated and plotted in all subjects.

Conditions
-----------------
Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: normal volunteer stroke Exclusion Criteria: who is unable receiving MRI examination pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Topical Compounded Pain Creams And Pain Perception (TOPCAPP)

Study Overview
=================
Brief Summary
-----------------
To evaluate the change in patient pain perception with the use of a topical compounded pain cream regimen.

Detailed Description
-----------------
This is a prospective,observational,single center, open label study of patients that receive a combination topical compounded analgesic medication with no comparator group.

Official Title
-----------------
Topical Compounded Pain Creams And Pain Perception (TOPCAPP)

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must be diagnosed with an ICD9 code indicative of chronic pain. Participants must be starting a new regimen of topical therapy with multiple compounded agents. Participants must be expecting to receive therapy for at least 12 weeks. Participants must be between 18 and 65 years of age. Participants must be able to provide sound written and verbal informed consent. Exclusion Criteria: Participants must not have prior hypersensitivity or adverse events to any of the components in the customized prescription. Participants must not be pregnant or breastfeeding women. Participants must not have a diagnosis of cancer within the past 5 years.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived pain changes | Minimal sample size of 60 persons(maximum n=150)with a diagnosis of chronic pain (n=30 neuropathic and n=30 nociceptive primary pain-type)to determine predictors of a 30% or greater reduction of pain scores evaluated by logistic regression analyses utilizing the Brief Pain Index scores. | 12 Week Study [Baseline, 4,8, and 12 week evaluation] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | To evaluate the change in quality of life using the EuroQol-5D-3L survey. | 12 Weeks [Baseline,4,8, and 12 week evaluation] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Topical Compounded Pain Creams and Pain Perception
Prospective Study on Plasma Pro-endothelin-1 in Predicting Bronchopulmonary Dysplasia

Study Overview
=================
Brief Summary
-----------------
Serial quantitative measurements of plasma pro-endothelin-1 concentrations in very preterm infants. Comparing pro-endothelin-1 with established clinical indices of bronchopulmonary dysplasia (BPD). Hypothesis: Pulmonary-vascular remodeling in infants developing BPD is directly related to circulating pro-endothelin-1, which therefore serves as surrogate marker of BPD.

Official Title
-----------------
Prospective Study on Plasma Pro-endothelin-1 in Predicting Bronchopulmonary Dysplasia

Conditions
-----------------
Bronchopulmonary Dysplasia

Intervention / Treatment
-----------------
* Other: blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Very preterm infants born before 32 weeks gestational age Exclusion criteria: Severe fetal malformation, congenital heart defect, inborn syndrome, cardiomyopathy, fetal hydrops

Ages Eligible for Study
-----------------
Minimum Age: 2 Weeks
Maximum Age: 4 Months

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 |
| --- | --- |
| VLBW infants<br> | Other: blood sampling<br>* blood sampling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of supplemental oxygen requirement | Bronchopulmonary dysplasia | 36 weeks postmenstrual age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of respiratory pressure support | respiratory pressure support either mechanical and/or nCPAP (days) | during hospitalisation |
A Study Evaluating the Long-Term Safety of Elexacaftor Combination Therapy

Study Overview
=================
Brief Summary
-----------------
This study evaluate the long-term safety and tolerability of elexacaftor (ELX)/tezacaftor (TEZ)/ ivacaftor (IVA) triple combination (TC) in participants with cystic fibrosis (CF) who are homozygous for F508del.

Official Title
-----------------
A Phase 3b Open-label Extension Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: ELX/TEZ/IVA
* Drug: IVA


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Completed study drug treatment in parent study (VX18-445-109); or had study drug interruption(s) in parent study but completed study visits up to the last scheduled visit of the Treatment Period in the parent study Key Exclusion Criteria: History of study drug intolerance in parent study Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 12 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: ELX/TEZ/IVA<br>Part A: Participants received elexacaftor (ELX) 200 milligram (mg) once daily (qd)/tezacaftor (TEZ)100 mg qd/ivacaftor (IVA)150 mg every 12 hours (q12h) in the treatment period for 48 weeks. Part B: Participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period up to 86 weeks. | Drug: ELX/TEZ/IVA<br>* Fixed-dose combination (FDC) tablet for oral administration.<br>* Other names: elexacaftor/tezacaftor/ivacaftor;Drug: IVA<br>* Tablet for oral administration.<br>* Other names: ivacaftor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |  | From Day 1 up to Week 52 | 
| Part B: Safety and Tolerability as Assessed by Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |  | From Day 1 up to Week 86 |
Audit on Anemia Variation After Major Gynacological Surgery

Study Overview
=================
Brief Summary
-----------------
The study aims to increase our understanding of variability in adherence to anaemia management guidelines and to assess the impact of anaemia management in clinical care following major gynaecological surgery

Detailed Description
-----------------
Anemia affects nearly a quarter of the world and is common in surgical patients with a third of patients presenting with preoperative anemia and three quarters of patients discharged from hospital with anemia. The World Health Organization defines anemia as an insufficient circulating red cell mass, with haemoglobin (Hb) concentration of < 130 g.l-1 for men and < 120 g.l-1 for women . Perioperative anemia is associated with increased postoperative complications and delayed patient recovery leading to increased post-operative morbidity and mortality. Anaemia also leads to an increased use of allogeneic blood transfusions, which is an independent risk for poorer patient outcomes. Postoperative anemia can be due to blood loss at operation or secondary to the inflammatory process associated with surgery, which causes an increase in hepcidin production resulting in functional iron deficiency and reduced red cell production. In recent years, there has been a significant increase in the use of intravenous iron therapy for preoperative anemia in line with major international guidelines

Official Title
-----------------
an Audit on Postoperative Variations in Anemia Treatment After Major Gynecological Surgery

Conditions
-----------------
Anemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: Adult, 18_60 years Procedure: A major gynecological surgery is defined as an operation with an incision into the abdominal cavity and anticipated duration of more than one hour. Procedures performed using any surgical approach, including open and laparoscopic surgery are included. Urgency: Patients undergoing planned (elective or expedited) or unplanned (emergency) surgery Exclusion Criteria: Procedures: surgery classified as minor operations such as; diagnostic laparoscopy (emergency or elective), D&C. Indication: Palliative procedures as determined pre-operatively and explicitly stated in the medical record or consent form. Return to theatre: Each patient should only be included in the study once. Patients returning to theatre due to complications following earlier surgery

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

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

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 |
| --- | --- | --- |
| the rate of anemia after major gynecological surgery | percentage of patients with anemia after surgery | one month |
Analysis of Induced Sputum and Lung Biopsies by SEM: a Tool to Identify Source of Exposure of Workers to Hazardous Dust

Study Overview
=================
Brief Summary
-----------------
Aim : to validate the qualitative analysis by Scanning Electron Microscope (SEM) of lung samples first in induced sputum in correlation to disease second by comparing hazardous particles in induced sputum to the analysis in lung tissue and finally by assessing if the particles present in transplanted patients correlated with occupational history.

Detailed Description
-----------------
Abstract Background: On the last few years there is a rise in the public awareness of the danger potential that lies in the exposure to hazardous dust in different professions. The examination of induced sputum has been used from the early eighties to research and diagnose inflammatory lung diseases. We assess here patients with lung disease and occupational history, in order to undergo work up to assess hazardous dust exposure. Aim : to validate the qualitative analysis by Scanning Electron Microscope (SEM) of lung samples first in induced sputum in correlation to disease second by comparing hazardous particles in induced sputum to the analysis in lung tissue and finally by assessing if the particles present in transplanted patients correlated with occupational history. Methods: 40 patients referred with occupational history were included. For 24 of them SEM analysis was done in induced sputum (IS) together with questionnaires and in 11 among them the SEM analysis was done both from lung tissue (TS) and IS. In addition 11 lung biopsies from patients with occupational history were scanned by SEM and compared to 10 biopsies from patients with no occupational history.

Conditions
-----------------
Occupational Exposed Population

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Occupational exposed workers
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IS-SEM
Healing Assessment of Osseous Defects After Surgical Removal of Periapical Lesions

Study Overview
=================
Brief Summary
-----------------
recruited patients with periapical lesions will be divided into three groups and surgically treated with three types of bone graft (hydroxyappatite, nanohydroxyappatite and PRF WITH NANOHYDROXTAPPATITE) and then evaluated for month, three months and six months for the healing of periapical bone

Official Title
-----------------
Healing Assessment of Osseous Defects After Surgical Removal of Periapical Lesions in the Presence of Hydroxyapatite, Nanohydroxyapatite and Combination of Nanohydroxyapatite and Platelet-rich Fibrin. A Clinical Study

Conditions
-----------------
Effects of the Elements

Intervention / Treatment
-----------------
* Procedure: surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient will be in range of 20-45 years of age at the time of treatment, having periapical lesions starting from 5mm or more in diameter related to failed endodontically treated single canaled teeth. Exclusion Criteria: Any systemic debilitating disease such as: Diabetes mellitus, renal disease, Liver disease or liver failure, Rheumatoid arthritis, Neoplastic disease or its treatment, chronic corticosteroid therapy, chronic hepatitis B or C , History of hepatitis A, pregnant females.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: hydroxyappatite<br>hydroxyapatite powder used for enhancement of bone regeneration | Procedure: surgery<br>* applying the graft inside bony defect after surgery<br>|
| Other: nanohydroxyapatite<br>nanohydroxyapatite powder used for enhancement of bone regeneration | Procedure: surgery<br>* applying the graft inside bony defect after surgery<br>|
| Other: PRF with nanohydroxyapatite<br>platelet rich fibrin mixed with nanohydroxyapatite used for enhancement of bone regeneration | Procedure: surgery<br>* applying the graft inside bony defect after surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| healing of periapical lesion | change in size of bony defect | interappointment at 1 month, 3 months and 6 months |
Study Evaluating Levonorgestrel and Ethinyl Estradiol in Oral Contraception

Study Overview
=================
Brief Summary
-----------------
To evaluate the contraceptive efficacy of an oral contraceptive containing a combination of LNG 90 mg/EE 20 mg in a continuous-use regimen and to evaluate the safety compared to LNG 100 mg/EE 20 mg for 21 days followed by a 7-day hormone-free interval in a cyclic regimen.

Official Title
-----------------
A Multicenter, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Levonorgestrel 90 Mg and Ethinyl Estradiol 20 Mg in a Continuous 28-Day Regimen for Oral Contraception Versus a Cyclic 21-Day Regimen Oral Contraceptive

Conditions
-----------------
Oral Contraceptive

Intervention / Treatment
-----------------
* Drug: Levonorgestrel 90 mg and Ethinyl Estradiol 20 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy women aged 18 to 49 years who are willing to rely upon a combination birth control pill as their only method of contraception. Women must be sexually active and at risk for becoming pregnant. Women must have had regular (21- to 35- day) menstrual cycles for the 3-month period preceding study visit 1. Exclusion Criteria: High blood pressure Age greater then 34 and smoking more than 15 cigarettes per day. Depression requiring hospitalization or associated with suicidal ideation within the last 3 years.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

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

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

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

Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Levonorgestrel 90 mg and Ethinyl Estradiol 20 mg|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the contraceptive efficacy of an OC containing a combination of LNG 90 mg/EE 20 mg in a continuous-use regimen and the safety compared to LNG 100 mg/EE 20 mg for 21 days followed by a 7-day hormone-free interval in a cyclic regimen |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effects on vaginal bleeding profile, hemostatic balance, lipid, carbohydrate, bone metabolism measures, hemoglobin levels, discontinuation rates, compliance with respect to pill taking, subject satisfaction |  |  | 

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