louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05474443: Comparison of Instrument Assisted Soft Tissue Mobilization and Myofascial Gun in Upper Cross Syndrome
Official title: Comparison of Instrument Assisted Soft Tissue Mobilization and Myofascial Gun in Upper Cross Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postural; Defect
Keywords: Upper Cross Syndrome
Instrument Assisted Soft Tissue Mobilization
Myofascial gun
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 30 participants were recruited in study and divided into two groups. Group A was given intervention with Instrument Assisted Soft Tissue Mobilization and Group B with Myofascial gun
Primary purpose: TREATMENT

Brief summary: To compare the effects of Instrument Assisted Soft Tissue Mobilization and Myofascial gun in Upper Cross Syndrome

Detailed description: Upper Cross Syndrome is a very common postural abnormality developed due to prolong slouched postures in desk jobs and also in students. Janda explained it that it is simultaneous presence of Forward Head Posture and protracted shoulders.

This includes weakness of lower and middle trapezius, deep neck flexors, rhomboids and serratus anterior. It also includes tightness of upper trapezius, Sternocleidomastoid, Pectoralis major and minor. The simultaneous occurrence of FHP and rounded shoulder is nothing but upper crossed syndrome.

Upper Trapezius is the primary muscle that is involved in Upper Cross Syndrome. Instrument Assisted Soft Tissue Mobilization is applied over the tight muscles to improve muscle length to its normal length. It is applied from origin to insertion with some pressure to apply compression on the muscle.

Myofascial gun is a recent technology that can be applied by the clinician and also by the affected person for self mobilization. They provide varying amount of frequencies through various shaped heads according to the area they are used,

Eligibility criteria: Inclusion Criteria:

• Patients with forward head posture and upper crossed syndrome

Exclusion Criteria:

* Congenital anomalies of shoulder
* Malalignment/previous fracture of clavicle
* Malignancy and Tuberculosis of spine
* Pigeon and Barrel chest

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: 4th week
measure: Tragus to wall distance test
timeFrame: 4th week
measure: Neck Disability Index
timeFrame: 4th week
measure: Inclinometer
timeFrame: 4th week
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Pakistan Railway General Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Affan Iqbal, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00123643: Vascular Effects of Rosiglitazone Versus Glyburide in Type 2 Diabetic Patients
Official title: Comparison of Rosiglitazone Versus Glyburide on Vascular Structure and Function in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: thiazolidinedione
sulfonylurea
endothelial function
Lead sponsor: St. Paul Heart Clinic
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2005-07-25
Enrollment: 36
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare the vascular effects of two commonly used diabetes medications, rosiglitazone and glyburide in type 2 diabetic patients.

Detailed description: Rosiglitazone and glyburide are two commonly used diabetic medications that have both been shown to be effective in controlling blood glucose levels. Since they work in different ways, they may have different effects on the health of the blood vessels. This study will assess which medication is better at improving the health of the arteries separate from the blood glucose lowering effects. Artery health will be assessed non-invasively by ultrasound. Certain markers of atherosclerosis found in the blood will also be measured.

Eligibility criteria: Inclusion Criteria:

* Age 25-75 years
* Type 2 diabetes mellitus for less than or equal to 10 years
* Pre-screening HbA1c \> 6.5 %
* Screening 110 mg/dl \< fasting plasma glucose \< 240 mg/dl after 2 weeks of metformin 500 mg twice daily (b.i.d.)

Exclusion Criteria:

* Thiazolidinedione or sulfonylurea use in previous 30 days (may undergo washout period of 30 days)
* Known contraindications to use of thiazolidinedione or sulfonylurea
* Female patients must be postmenopausal, surgically sterile, or using adequate contraception
* Uncontrolled hyperlipidemia according to American Heart Association (AHA) guidelines
* Subcutaneous insulin use
* Elevated liver enzymes (2.5 times the upper limit of the reference range)
* Serum creatinine \>160 mmol/l
* Anemia (Hb \<11 g/dl for men or \<10 g/dl for women)
* Body mass index (BMI) \<22 or \>42 kg/m2
* History of ketoacidosis
* Angina/New York Health Academy class III/IV cardiac insufficiency
* Electrocardiographic evidence of marked left ventricular hypertrophy
* Uncontrolled hypertension according to AHA guidelines
* Hemoglobinopathy

Primary outcomes:
measure: Flow Mediated Dilation
timeFrame: change from baseline to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: St. Paul
country: United States
facility: St. Paul Heart Clinic
state: Minnesota
Study officials:
affiliation: St. Paul Heart Clinic
name: Alan J Bank, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02587143: Ethyl Chloride Vapocoolant as Anesthesia for Arterial Punctures
Official title: Ethyl Chloride Vapocoolant as Anesthesia for Arterial Punctures: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Pain
Lead sponsor: Bionorte
Sponsor class: OTHER
Collaborators: name: Osakidetza
name: University of the Basque Country (UPV/EHU)
First posted: 2015-10-27
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ethyl chloride vapocoolant sprays provide transient skin anesthesia within seconds of application. The current investigation aim is to compare the effect of ethyl chloride based vapocoolant spray to placebo in reducing pain associated with arterial puncture for gasometry determinations.

The investigators will conduce a double-blind randomized placebo-controlled trial at Emergency Department.

We will enroll patients who come to Emergency Department who need an arterial gasometry determination. Patients will be randomized to intervention-group (ethyl chloride vapocoolant sprays will be usad before arterial puncture) or to placebo-group (alcohol spray as placebo will be used before arterial puncture.) and after the puncture they will rate their pain using a 10 points visual analogue scale.

Detailed description: Single-blind, randomized placebo-controlled trial in an emergency department of Hospital de Basurto in Bilbao, Spain. Patients for whom arterial blood gas analysis had been ordered will be included. They will be randomly assigned to receive application of the experimental ethyl chloride spray or a placebo aerosol spray of a solution of alcohol in water. The assigned spray will be applied just before arterial puncture. The main outcome variable is pain intensity reported on an 11-point numeric rating scale.

Eligibility criteria: Inclusion Criteria:

* age: 18-85 years old.
* arterial gasometry determination needed
* III, IV or V level classification on Manchester triage.

Exclusion criteria:

* refusal to participate,
* inability to provide informed consent (non-Spanish speaking, dementia or altered mental state),
* skin disease associated with cold intolerance (Raynaud's phenomenon),
* known allergy to spray contents,
* Glasgow Coma Scale \<15,
* pregnancy,
* under effects of alcohol or drugs,
* Allen test +.

Primary outcomes:
measure: Pain Level on the Visual Analog Scale (NRS-11)
timeFrame: scores on a scale immediately after the puncture
Secondary outcomes:
Other outcomes:
Locations:
city: Bilbao
country: Spain
facility: Hospital de Basurto
state: Bizkaia
Study officials:
affiliation: HOSPITAL OF BASURTO (BILBAO)
name: SENDOA BALLESTEROS-PEÑA, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ballesteros-Pena S, Fernandez-Aedo I, Vallejo-De la Hoz G; en representacion del Grupo de Trabajo DIASURE. [Ethyl chloride aerosol spray for local anesthesia before arterial puncture: randomized placebo-controlled trial]. Emergencias. 2017 Jun;29(3):161-166. Spanish.
Clinical trial NCT05083390: Norursodeoxycholic Acid vs. Placebo in NASH
Official title: Double-blind, Randomised, Placebo-controlled, Phase IIb Trial on the Efficacy and Safety of Norursodeoxycholic Acid Tablets in Patients With Non-alcoholic Steatohepatitis (NASH)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Nonalcoholic Steatohepatitis
Lead sponsor: Dr. Falk Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2021-10-19
Enrollment: 363
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a double-blind, randomised, multi-centre, placebo-controlled, comparative, phase IIb trial. The trial will be conducted with three treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with either 1500 mg/d or 1000 mg/d norUDCA tablets vs. placebo tablets for the treatment of NASH.


Eligibility criteria: Inclusion Criteria:

* Must be willing to participate in the study and provide written informed consent
* Male or female patients ≥ 18 and \< 75 years
* Centrally assessed histological evidence of NASH and liver fibrosis
* Women of childbearing potential agree to use a highly effective method of birth control during the entire duration of the trial and for 4 weeks following the last dose of trial treatment

Exclusion Criteria:

* Patients taking prohibited medications
* Presence of liver cirrhosis
* Type 1 diabetes or uncontrolled Type 2 diabetes
* History or presence of any other significant concomitant liver diseases
* History of liver transplantation
* BMI \>45 kg/m\^2
* Any known relevant infectious disease (e.g., active tuberculosis, acquired immunodeficiency syndrome \[AIDS\]-defining diseases)
* Abnormal renal function (glomerular filtration rate estimated from cystatin C \< 30 ml/min) at screening visit
* Any active malignant disease (except for basal cell carcinoma)
* Existing or intended pregnancy or breast-feeding

Primary outcomes:
measure: Number of participants with resolution of NASH, assessed by centrally scored liver histology, and no worsening of fibrosis AND/OR improvement of fibrosis, and no worsening of NAS
timeFrame: 72 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Internal Medicine III
Study officials:
affiliation: Medical University of Vienna, Department of Internal Medicine III
name: Michael Trauner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03177590: Recording Facial and Vocal Emotional Productions in Children With Autism as Part of the JEMImE Project
Official title: Recording Facial and Vocal Emotional Productions in Children With Autism as Part of the JEMImE Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Pervasive Developmental Disorder
Keywords: autism
Pervasive Developmental Disorder
Lead sponsor: Fondation Lenval
Sponsor class: OTHER
First posted: 2017-06-06
Enrollment: 35
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of the JEMImE project is to create a serious game to help children with Autism and Pervasive Developmental Disorder (PDD) develop facial and vocal emotions in context.

The objective of this study is to record facial and vocal emotional productions in children with autism and PDD in order to create an algorithm for the recognition of facial emotional expressions implemented in the serious game JEMImE.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of autism and Pervasive developmental disorder according to Diagnostic and Statistical Manual of Mental Disorders IV (DSM IV) criteria using scales (Autism Diagnostic Interview ADI and / or Autism Diagnostic Observation Schedule ADOS).
* Intelligence Quotient (IQ) = /\> 70 (Wechsler Intelligence Scale for Children WISC IV)
* Subjects and holders of parental authority who have given their informed and written consent
* Subjects affiliated to social security system.

Exclusion Criteria:

* Subjects non affiliated to social security system.

Primary outcomes:
measure: Record facial and vocal emotional productions of children of an imitation situation
timeFrame: At baseline
Secondary outcomes:
measure: Record facial and vocal emotional productions of children in a situation of mime on written request
timeFrame: At baseline
measure: Record facial and vocal emotional productions of children in a situation of mime on presentation of an image
timeFrame: At baseline
Other outcomes:
Locations:
city: Nice
country: France
facility: Fondation Lenval Hôpitaux Pédiatriques de Nice CHU-LENVAL
city: Paris
country: France
facility: Hôpital de La Salpétrière - APHP
Study officials:
affiliation: Fondation Lenval Hôpitaux Pédiatriques de Nice CHU-LENVAL
name: Sylvie SERRET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05306990: Statins in Patients With Type 2 Diabetes Mellitus and Previous History of Acute Coronary Syndrome
Official title: Efficacy and Safety of Atorvastatin 40mg Versus Rosuvastatin 20mg in Type II Diabetic Patients With Previous Acute Coronary Syndrome : Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hydroxymethylglutaryl-CoA Reductase Inhibitors
Diabetes Mellitus
Keywords: High intensity statin therapy
Acute coronary syndrome
Atorvastatin
Rosuvastatin
Diabetes mellitus
Lead sponsor: Helwan University
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the efficacy and safety of high dose atorvastatin (40 mg) versus high dose rosuvastatin (20 mg) in Egyptian type II diabetic patients with previous acute coronary syndrome history. This open-labeled prospective, randomized clinical trial compared once daily atorvastatin 40mg (Ator®) versus once daily rosuvastatin 20mg (Crestor®). The primary outcome was the 50% reduction in low-density lipoprotein cholesterol levels at 12 weeks. The secondary outcome was the achievement of low-density lipoprotein cholesterol level \< 55 mg/dl.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis with type 2 diabetes.
* Previous history of acute coronary syndrome.
* Abnormal baseline lipid profile.

Exclusion Criteria:

* Patients taking concurrent lipid lowering agents such as bile acid sequestrants (cholestyramine, colesevelam), niacin, ezetimibe, fenofibrate and/or omega3.
* Patients taking concurrent interacting medications such as ciclosporin, gemfibrozil, clarithromycin and/or itraconazole.
* Patients with active liver disease, bile duct problems, or ALT \> 3 × upper limit of normal (ULN).
* Patients with serum creatinine \> 2 mg/dl.
* Patients have incidence or history of hypersensitivity reaction to any of the statin used.
* Women who were pregnant, breast-feeding or of child-bearing potential and not using a reliable form of contraception at the time of recruitment

Primary outcomes:
measure: Mean Change from baseline in Low Density Lipoprotein Cholesterol (LDL-C)
timeFrame: Post intervention at week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Heart Institute
Study officials:
References:
Clinical trial NCT04472390: Study of Tapering and Discontinuing Biological DMARDs in Rheumatoid Arthritis Patients
Official title: Study of Tapering and Discontinuing Biological DMARDs in Rheumatoid Arthritis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Keywords: biological DMARDs
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-07-15
Enrollment: 400
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: There are 90 patients included in this cohort study, 89 patients underwent tapering of TNF-α inhibitors.

Brief summary: This study aims to analyses time to disease relapse of RA patients if TNF-α inhibitors are being tapered, the predictive factors that are associated with successful taper of TNF-α inhibitors. Also, investigate the effects associated with dose tapering of TNF-α inhibitors.


Eligibility criteria: Inclusion criteria:

Diagnosed of RA based on the 1987 American College of Rheumatology (ACR) criteria and/or 2010 ACR/EULAR classification criteria of RA depending on the time of diagnosis Age ≥ 20 years old TNF-α inhibitors was prescribed for RA patients refractory to csDMARDs (defined as csDMARD therapy for over 6 months) during 2003/5/2 - 2017/4/30 Dose reduction or discontinuation use of TNF-α inhibitors (2011/1/1-2019/4/30)

Exclusion criteria:

TNF-α inhibitors were discontinued or tapered due to adverse events such as infection, liver transaminase elevation, malignancy and neutropenia.

Primary outcomes:
measure: time to disease relapse
timeFrame: hrough study completion, an average of 10 year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Zhongzheng District
Study officials:
affiliation: NTU Clinical Pharmacy School
name: Yen-Hui Chen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05581290: A Study of a Multi-Modal Sensor Patch for Real-Time Physiological Monitoring and Inference
Official title: AI-Flex: An Artificial Neural Network Integrated Flexible Multi-Modal Sensor Patch for Real-Time Continuous Physiological Monitoring and Inference
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Disease
Keywords: Underlying Cardiac Structural Condition
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this research is to validate the prototype AI-Flex device. Researchers at Mayo Clinic developed a new a flexible multi-modal bio-sensing device, AI-Flex, with integrated artificial intelligence (AI) capability. Integration of sensing and AI analysis on the same device removes the need for data storage on the cloud for later analysis. The goal of the device is to allow real-time monitoring of patient health and timely intervention based on patient health condition. It is hoped that the proposed flexible device will allow intimate skin contact using ultra-thin (\<10 µm) geometry to reduce or eliminate relative movement between the skin and flexible epidermal sensors even during rapid motion of the subject, which would significantly improve the sensor signal quality for AI analysis.


Eligibility criteria: Inclusion Criteria:

* Subject must be referred for Cardiology Clinic Visit.
* Subject must have underlying cardiac structural disease or condition to increase yield of clinically significant transmission
* Subject must be 18 - 85 years of age.

Exclusion Criteria:

- \< 18 years of age or \> 85 years of age.

Primary outcomes:
measure: AI-Flex ECG Accuracy
timeFrame: Baseline
measure: AI-Flex Temperature Measurement Accuracy
timeFrame: Baseline
measure: AI-Flex PPG Measurement Accuracy
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Imon Banerjee
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Imon Banerjee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06618690: Exercise Program on Pain, Physical Function, and Quality of Life in Breast Cancer Survivors
Official title: Efficacy of a Supervised Exercise Program on Pain, Physical Function, and Quality of Life in Breast Cancer Survivors: Protocol for a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Female Breast Cancer
Keywords: breast cancer
exercise
quality of life
muscle strength
Lead sponsor: Universidad de Burgos
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 325
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this project is to develop a randomized clinical trial to determine the efficacy of a supervised exercise program on pain, physical function and quality of life in female breast cancer survivors

Detailed description: A randomized, double-blind, clinical trial will be conducted with 325 participants. The intervention group will receive a supervised exercise program for 12 weeks, while the control group will receive no intervention. Participants\&#39; pain, physical function and quality of life will be assessed at baseline, post-intervention and 12 weeks post-intervention.

Eligibility criteria: Inclusion Criteria:

* women between 18 and 65 years of age,
* women with oncologic treatment completed less than 3 months ago,
* women without metastasis,
* women without pathologies that contraindicate exercise,
* women who have agreed to sign the informed consent form

Exclusion Criteria:

* not attending scheduled sessions to instruct on the exercises to be performed, - being part of other studies,
* undergoing another type of therapy
* pregnancy patients.

Primary outcomes:
measure: repeated measures ANOVA
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Àlmeria
country: Spain
facility: Hospital Universitario Torrecárdenas
state: Alemeria
Study officials:
References:
citation: Iwase T, Wang X, Shrimanker TV, Kolonin MG, Ueno NT. Body composition and breast cancer risk and treatment: mechanisms and impact. Breast Cancer Res Treat. 2021 Apr;186(2):273-283. doi: 10.1007/s10549-020-06092-5. Epub 2021 Jan 21.
citation: Michels D, Konig S, Heckel A. Effects of combined exercises on shoulder mobility and strength of the upper extremities in breast cancer rehabilitation: a 3-week randomized controlled trial. Support Care Cancer. 2023 Sep 1;31(9):550. doi: 10.1007/s00520-023-07959-1.
citation: Tuchler A, De Pauw A, Ernst C, Anota A, Lakeman IMM, Dick J, van der Stoep N, van Asperen CJ, Maringa M, Herold N, Blumcke B, Remy R, Westerhoff A, Stommel-Jenner DJ, Frouin E, Richters L, Golmard L, Kutting N, Colas C, Wappenschmidt B, Rhiem K, Devilee P, Stoppa-Lyonnet D, Schmutzler RK, Hahnen E. Clinical implications of incorporating genetic and non-genetic risk factors in CanRisk-based breast cancer risk prediction. Breast. 2024 Feb;73:103615. doi: 10.1016/j.breast.2023.103615. Epub 2023 Nov 29.