linjc16/ctgov huggingface dataset:
APremilast After FumaRic Acid Ester Treatment

Study Overview
=================
Brief Summary
-----------------
Patient treatment preference and treatment satisfaction of physicians and patients comparing fumaric acid ester therapy with subsequent apremilast treatment

Official Title
-----------------
Real-world Benefit of Apremilast Treatment of Patients With Moderate-to-severe Psoriasis After Transition From Fumaric Acid Esters

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: Phase I: Fumaric acid esters. Phase II: Apremilast


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients ≥18 years Moderate to severe plaque-type psoriasis according to SmPC Phase I: Patients will be included once they are started on systemic fumaric acid esters (e.g. Fumaderm initial®) for the treatment of moderate-to-severe psoriasis vulgaris. Patients initiated on fumaric acid esters will be followed for a maximum of 24 weeks during phase I. Patients continued on fumaric acid esters beyond 24 weeks or switched to a therapy other than apremilast during or at the end of the 24-week phase I period will no longer be followed. Phase II: Patients switched to apremilast during or at the end of the 24-week phase I period will be included in phase II and followed for additional 32 weeks. Written informed consent Exclusion Criteria: Prior treatment with biologics According to SmPC Participation in another clinical trial (parallel inclusion in the National psoriasis registry PsoBest is allowed)

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 |
| --- |
|Drug: Phase I: Fumaric acid esters. Phase II: Apremilast|Apremilast|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean absolute value of the overall TSQM score at week 24 of apremilast (APR) therapy (phase II). |  | 56 weeks |
Relationship of Skeletal Muscle Thickness, Strength, and Diaphragm Function in Adults With CF

Study Overview
=================
Brief Summary
-----------------
31 CF patients and 23 healthy sex and age-matched volunteers were enrolled. All subjects underwent pulmonary function tests, 6-minute walking tests. Body Mass Index and Fat Free Mass Index were measured via a body composition analyser. Diaphragm ultrasonography (to measure thickening fraction), quadriceps femoris muscle ultrasonography were performed. A dynamometer was used to measure each subjects handgrip strength.

Official Title
-----------------
Relationship of Skeletal Muscle Thickness, Strength, and Diaphragm Function in Adults With CF

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CF diagnosed Age 18 and above Exclusion Criteria: Having a pulmonary flare up within the previous month Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| CF patients<br> | |
| Controls<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle Thickness, Strength and Diaphragm Thickening Fraction of CF Patients | Measured via USG and handheld dynamometer | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CF, nutritional status, peripheral muscle thickness, peripheral muscle strength, diaphragm thickening fraction
Clinical Trial Between Laparoscopic Gastric Bypass and Laparoscopic Vertical Banded Gastroplasty for Morbid Obesity

Study Overview
=================
Brief Summary
-----------------
This is a randomized clinical trial assessing the outcome of two surgical strategies to treat severe obesity; laparoscopic gastric bypass and laparoscopic VBG. Main outcome is weight loss and weight loss maintenance but other factors as body composition, eating pattern, metabolic normalisation, energy expenditure will also be assessed.

Official Title
-----------------
Randomized Clinical Trial Between Laparoscopic Gastric Bypass and Laparoscopic Vertical Banded Gastroplasty for Morbid Obesity

Conditions
-----------------
Morbid Obesity

Intervention / Treatment
-----------------
* Procedure: Laparoscopic gastric bypass
* Procedure: Laparoscopic VBG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 35-50 kg/m2 20-60 y Exclusion Criteria: Severe co-morbidity Unmotivated to long term follow up

Ages Eligible for Study
-----------------
Minimum Age: 20 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic gastric bypass<br> | Procedure: Laparoscopic gastric bypass<br>* Laparoscopic gastric bypass surgery<br>|
| Active Comparator: Laparoscopic VBG<br>Laparoscopic vertical banded gastroplasty | Procedure: Laparoscopic VBG<br>* Laparoscopic vertical banded gastroplasty<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss |  | 1, 2, 5 and 10 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition |  | 1, 2, 5 and 10 years after surgery | 
| Eating pattern |  | 1, 2, 5 and 10 years after surgery | 
| Energy expenditure |  | 1, 2, 5 and 10 years after surgery | 
| Gut hormonal response |  | 4 and 10 years after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, weight loss, surgery, gastric bypass, VBG
Comparative Study Between the AirGoTM System and Standard Tests in the Assessment of the Respiratory Function

Study Overview
=================
Brief Summary
-----------------
The study aims at evaluating the AirGoTM system's performance, as compared to standard pulmonary function tests.

Detailed Description
-----------------
Primary endpoint: • To test the AirGoTM system's respiratory rate recording accuracy at rest and during physical exercise, as compared to standard tests. Secondary endpoints: To test the accuracy of the AirGoTM system's derived respiratory parameters (tidal volume, minute ventilation, Tiffeneau-Pinelli index, FEV1 and VO2max) at rest and during physical exercise, as compared to standard tests. To test comfort and subjects' compliance with the AirGoTM system during long term recording (24 hours).

Official Title
-----------------
Comparative Study Between the AirGoTM System and Standard Tests in the Assessment of the Respiratory Function

Conditions
-----------------
Respiration Disorders

Intervention / Treatment
-----------------
* Other: Electronic evaluation system
* Other: Electronic evaluation system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-smoker healthy volunteers, Able to perform a routine respiratory function test (spirometry and cardiopulmonary exercise testing), aged between 18 and 75 years, who signed a written informed consent. Exclusion Criteria: Present cardiac comorbidities (eg. coronary artery disease, heart failure, arrhythmias); History of coronary artery disease or heart failure; Respiratory comorbidities (eg. asthma, chronic obstructive disease, sleep apnoea, lung interstitial disease); Pregnancy; Former smoker of >5 p/y; Severe trauma or major surgery in the last year; Chest pain; Obesity (BMI >30).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Electronic evaluation system|spirometry, plethysmography, cardiopulmonary exercise test|
|Other: Electronic evaluation system|AirGo recording|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| respiratory rate | number of respiratory cycles completed in one minute | 4 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tidal volume | volume of air moved during a single respiratory cycle (inspiration and expiration) during normal breathing (in ml) | 4 minutes |
A Dose Finding Study of CpG in Patients With Chronic Lymphocytic Leukemia Who Have Been Previously Treated

Study Overview
=================
Brief Summary
-----------------
CpG has the potential to stimulate the immune system this study will evaluate the safety of CpG given sub-q or IV purpose is to measure biological changes in CLL cells after receiving CpG

Official Title
-----------------
A Dose-Finding Study of CpG 7909 in Previously Treated Chronic Lymphocytic Leukemia

Conditions
-----------------
Chronic Lymphocytic Leukemia

Intervention / Treatment
-----------------
* Drug: CpG 7909


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of CLL CLL previously treated Hemoglobin >/= 10 Platelets >/= 50,000 Neutrophils >= 1,000 - Exclusion Criteria: patients with brain mets patients with autoimmune disease patients on corticosteroids or immunosuppressants patients with uncontrolled intercurrent illness pregnant women HIV patients receiving combination anti-retroviral therapy

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPG 7909 IV<br>Intravenous infusions will be administered with a standard infusion pump beginning at 125 cc/hr through an intravenous catheter (central or peripheral). | Drug: CpG 7909<br> <br> |
| Experimental: CPG 7909 SQ<br>Subcutaneous injections should be administered in the abdominal wall, upper arm, hip, or anterior thigh. If the volume of injection exceeds 1.5 ml, the volume should be divided into equal injections at a volume less than 1.5 ml and administered in different areas of the body. The maximum dose level on this trial may require 5 - 6 injections at an equal number of sites. | Drug: CpG 7909<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum tolerated dose |  | at study completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response |  | at end of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CpG 7909, CLL
Stimulus Phase Duration on Discomfort and Electrically Induced Torque of Quadriceps Femoris

Study Overview
=================
Brief Summary
-----------------
This study aims to examine the variation in muscle torque and discomfort produced when electrically stimulating quadriceps femoris using pulsed current with three different phase durations in order to establish whether there are any advantages or disadvantages in varying the phase duration over the range examined.

Official Title
-----------------
The Influence of Stimulus Phase Duration on Discomfort and Electrically Induced Torque of Quadriceps Femoris

Conditions
-----------------
Torque, Pain Perception

Intervention / Treatment
-----------------
* Device: 400 microseconds
* Device: 700 microseconds
* Device: 1000 microseconds


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: sedentary healthy university students. Exclusion Criteria: history of knee surgery or injury, musculoskeletal, cardiovascular or neurological disease including impaired sensation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 400 microseconds<br>Electrically-induced torque generated with stimulus phase duration set at 400 microseconds. | Device: 400 microseconds<br>* Neuromuscular electrical stimulation with stimulus phase duration of 400 microseconds<br>|
| Experimental: 700 microseconds<br>Electrically-induced torque generated with stimulus phase duration set at 700 microseconds. | Device: 700 microseconds<br>* Neuromuscular electrical stimulation with stimulus phase duration of 700 microseconds<br>|
| Experimental: 1000 microseconds<br>Electrically-induced torque generated with stimulus phase duration set at 1000 microseconds. | Device: 1000 microseconds<br>* Neuromuscular electrical stimulation with stimulus phase duration of 1000 microseconds<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Torque | Torque will be measured using an isokinetic dynamometer. Torque will be registered in Newton meter [N.m] | During 4 seconds of electrical stimulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discomfort | Discomfort will be measured using a 10 cm visual analogue scale (VAS) ranging from zero (no discomfort) to 10 (worst discomfort imaginable). | During 6 seconds of electrical stimulation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
electrical stimulation, torque
Clinical Validation Study for iVue

Study Overview
=================
Brief Summary
-----------------
To demonstrate clinical substantial equivalence of iVue as comparable to commercially available RTVue.

Official Title
-----------------
Clinical Validation Study for iVue

Conditions
-----------------
Normal and Ocular Pathology

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal: Normal results from clinical exam and free of ocular pathology. Glaucoma: Clinical exam results consistent with glaucoma and visual field defects consistent with glaucoma. Cornea: Clinical exam results consistent with cornea pathology. Retina: Clinical exam results consistent with retina pathology

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Normal<br>Normal results from clinical exam and free of ocular pathology. | |
| Retina<br>Clinical exam results consistent with retina pathology | |
| Glaucoma<br>Clinical exam results consistent with glaucoma and visual field defects consistent with glaucoma. | |
| Cornea<br>Clinical exam results consistent with cornea pathology. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| thickness of ocular structures |  |  |
Reducing Hypoglycemia Fear in Parents of Young Children With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
Pilot of a novel video-based telemedicine intervention to reduce fear of hypoglycemia in parents of young children with type 1 diabetes.

Detailed Description
-----------------
This was a two group randomized controlled study using a wait-list control design. All participating parents had the opportunity to receive 10 video-based telemedicine sessions administered over 13 weeks. Study assessments took place at baseline, post-treatment, and 3 month followup. Study outcomes included parent reported hypoglycemia fear, parenting stress, diabetes distress, and child glycated hemoglobin.

Official Title
-----------------
Reducing Hypoglycemia Fear in Parents of Young Kids Via Video-based Telemedicine

Conditions
-----------------
Parents

Intervention / Treatment
-----------------
* Behavioral: REDCHiP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents of children, between 1-6 years old, with type 1 diabetes for at least 6 months, on either multiple daily injections or an insulin pump, and parents speak English Exclusion Criteria: Families of children who are older than 6 years-old and or do not have type 1 diabetes; children follow a conventional insulin regimen

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 6 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
Interventional Model Description: randomized control pilot using a waitlist control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REDCHiP<br>10 week video-based telemedicine intervention to reduce parents hypoglycemia fear | Behavioral: REDCHiP<br>* 10 week video-based telemedicine intervention to reduce hypoglycemia fear<br>|
| No Intervention: Waitlist<br>10 week no intervention to provide waitlist control condition | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycemia Fear Survey | Hypoglycemia Fear Survey-Parents of Young Children. This is a measure of parents' perceived hypoglycemia fear. Higher scores suggest greater fear (worse outcome). Total possible range: 26-130. | absolute value at post-treatment (week 14) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Hemoglobin A1c | Child hemoglobin A1c- biological marker of glycemic control | absolute value at post-treatment (week 14) |
Efficacy and Safety of ASF-1096 Cream 0.5% in the Treatment of Discoid Lupus Erythematosus (DLE) Lesions (2)

Study Overview
=================
Brief Summary
-----------------
Lupus Erythematosus (LE) is an autoimmune disorder that includes a broad spectrum of clinical forms. One of these forms, Discoid Lupus Erythematosus (DLE) is a chronic disfiguring disease confined to the skin. The aim of this pivotal trial is to investigate the efficacy and safety of ASF-1096 cream 0.5% in the treatment of patients with DLE or SLE presenting newly developed discoid lesions.

Official Title
-----------------
Efficacy and Safety of ASF-1096 Cream 0.5% in the Treatment of Patients With Newly Developed Discoid Lupus Erythematosus (DLE) Lesions. An International Multi-Centre Clinical Phase 2, Placebo Controlled and Double Blind Proof of Concept Study (2)

Conditions
-----------------
Discoid Lupus Erythematosus

Intervention / Treatment
-----------------
* Drug: ASF 1096 0.5 % cream
* Drug: ASF 1096 placebo cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A clinical diagnosis of either DLE or SLE Histological results from biopsy confirming the diagnosis (biopsy can be taken at screening) Is prepared to grant authorised persons access to the medical records Has signed informed consent Exclusion Criteria: Has an active skin disease other than DLE or another progressive or serious disease that interferes with the study outcome Has scarring at the target lesion Systemic treatment of SLE

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: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: ASF 1096 0.5 % cream<br> <br> |
| Placebo Comparator: 2<br> | Drug: ASF 1096 placebo cream<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |