louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04984473: A Study to Evaluate Breathing Muscle Training in Cardiac Rehab
Official title: Combined Cardiac Rehabilitation and Inspiratory Muscle Training in Heart Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Heart Failure
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to understand if breathing muscle training combined with cardiac rehabilitation influences the blood flow and blood pressure response during exercise.


Eligibility criteria: Inclusion Criteria - Heart Failure Group:

* Adult 18 years and older.
* English speaking.
* Has a qualifying heart failure indication for center-based cardiac rehabilitation.

Inclusion Criteria - Healthy Control Group:

* Adult 18 years and older.
* English speaking.
* Absence of pulmonary, cardiovascular, musculoskeletal, neurologic, or orthopedic diseases. Controls will be matched for age and sex.

Exclusion Criteria:

* HF patients who are unable to engage in a regularly structured exercise training program as part of a clinically indicated center-based outpatient cardiac rehabilitation program.
* Participants unable/unwilling to provide informed consent.
* Uremia, history of allergy to iodides. Impaired renal function.
* Creatinine value greater than 1.3 mg/dL (via clinical record within the past 6 months).
* Diagnosis of liver disease.

Primary outcomes:
measure: Blood pressure response
timeFrame: baseline and 12 week follow up
measure: Change in blood flow response
timeFrame: baseline and 12 week follow up
measure: Change in limb vascular resistance response
timeFrame: baseline and 12 week follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Joshua Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00745173: Study Evaluating Premarin and Bazedoxifene Potential Interaction
Official title: An Open-Label, Single/Multiple Dose Non-Randomized, 3-Period, Crossover Study To Determine The Potential Drug Interaction Of Conjugated Estrogens (CE) On Bazedoxifene In Healthy Postmenopausal Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Postmenopause
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-09-03
Enrollment: 30
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the pharmacokinetics (absorption, distribution, breakdown and elimination in the body) of a single dose of bazedoxifene (BZA) 20 mg tablet when administered together with multiple doses of Premarin (conjugated estrogens or CE) to healthy postmenopausal women.

Information will also be obtained regarding the safety and tolerability of this combination in healthy, postmenopausal women.


Eligibility criteria: Inclusion Criteria:

* For inclusion into the study, women must be healthy and postmenopausal (either naturally or surgically) between the ages of 35 and 70, inclusive.
* Blood hormone levels must be consistent with a postmenopausal state (for specified subjects).
* They can either be a non-smoker or smoke less than 10 cigarettes per day, and be able to abstain from smoking during clinic confinements

Exclusion Criteria:

* A subject will be excluded from participation if they :
* Have participated in a clinical drug study within 30 days prior to study medication administration;
* Have a history of drug or alcohol abuse within 1 year or consume more than 2 standard units per day of alcohol (a standard unit equals 12 ounces of beer, 1 ½ ounces of 80-proof alcohol or 6 ounces of wine);
* Donate any other plasma or blood during the total study.

Primary outcomes:
measure: Pharmacokinetic (absorption, distribution, breakdown and elimination in the body) parameters
timeFrame: 3 months
Secondary outcomes:
measure: To continue assessment of the safety profile as well as the tolerability the two drugs administered in combination in this population.
timeFrame: 3 months
Other outcomes:
Locations:
city: Austin
country: United States
facility: Dr. David Carter
state: Texas
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01923831: Comparison of the Effect of Magnesium Sulfate and Dexamethasone on Postoperative Sore Throat After Spinal Surgery in Prone Position With Tracheal Intubation: a Double-blind, Randomized, Noninferiority Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Sore Throat
Keywords: Magnesium, Post operative sore throat, Prone position, Tracheal intubation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-08-16
Enrollment: 146
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
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 effect of magnesium sulfate and dexamethasone on postoperative sore throat after spinal surgery in prone position with tracheal intubation.


Eligibility criteria: Inclusion Criteria:

* ASA I-II patients aged between 20 and 65 year undergoing 1 or 2 level posterior spinal fusion in prone position with tracheal intubation

Exclusion Criteria:

* preexisting hoarseness or sore throat, upper respiratory tract infection
* steroid therapy or immunocompromised patients
* chronic treatment with calcium channel blocker or magnesium
* allergy to magnesium sulphate
* Cormack-Lehane grade 3,4 or patients who are expected to difficult intubation
* fail to tracheal intubation at first trial
* reduced kidney function
* Diabetes mellitus

Primary outcomes:
measure: The effect of magnesium sulfate on postoperative sore throat after spinal surgery in prone position with tracheal intubation
timeFrame: Change of post operative sore throat level from 1 to 48 hours after surgery
Secondary outcomes:
measure: The effect of dexamethasone on postoperative sore throat after spinal surgery in prone position with tracheal intubation
timeFrame: Change of post operative sore throat level from 1 to 48 hours after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT00384631: Intravitreal Bevacizumab for Neovascular Glaucoma
Official title: Intravitreal Bevacizumab for Neovascular Glaucoma; a Randomized Placebo Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neovascular
Glaucoma
Keywords: Neovascular
Glaucoma
Bevacizumab
Avastin
Intravitreal
IOP
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2006-10-06
Enrollment: 26
Sex: ALL
Minimum age (years): 10
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Several studies have confirmed high levels of vascular endothelial growth factor (VEGF) in eyes with neovascular glaucoma (NVG). The role of VEGF inhibitors in regression of other neovascular disorders such as wet-type age-related macular degeneration and diabetic macular edema has been described. We aim to evaluate the effect of three intravitreal injections of bevacizumab (Avastin) 2.5 mg versus a sham procedure for treatment of NVG. Outcome measures include intraocular pressure and extent of iris neovascularization. Both study arms will receive conventional treatment for NVG.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of NVG
* Vision less than 20/200
* age 10-80 years

Exclusion Criteria:

* Uncontrolled Blood Pressure
* History of thromboembolism
* Congestive Heart Failure
* Renal Failure
* Pregnancy or Lactation
* Active ocular or periocular infection
* No light perception

Primary outcomes:
measure: Change in intraocular pressure
timeFrame: 6 months
measure: Change in extent of iris neovascularization
timeFrame: 6 months
Secondary outcomes:
measure: Best corrected visual acuity
timeFrame: 6 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Labbafinejad Medical Center
Study officials:
affiliation: Ophthalmic Research Center, Shaheed Beheshti Medical University
name: Shahin Yazdani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01671631: The Diastolic Pressure Gradient for Patients With Acute Coronary Syndrome: Evaluation of Non Culprit Lesions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Functional Evaluation of Non Culprit Lesions in ACS Patients
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2012-08-23
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Acute Coronary Syndrome and multivessel coronary artery disease.

Brief summary: The assessment of non-culprit stenoses is an important issue in ACS. Adenosine administration is currently required for functional evaluation of stenosis severity using the fractional flow reserve (FFR). An alternative adenosine-independent index of coronary stenosis, the instantaneous wave-free ratio (iFR), was recently introduced.

Aim of the present study will be to evaluate the trans-stenotic instantaneous wave-free pressure gradient (iFG), the instantaneous wave-free ratio (iFR) and the fractional flow reserve (FFR) in ACS patients.


Eligibility criteria: Inclusion Criteria:

* age 40 to 80 years
* recent Acute Coronary Syndrome
* indication for coronary angiography
* presence of at least one non-culprit lesion requiring functional evaluation with fractional flow reserve (FFR):

Exclusion Criteria:

* Haemodynamically significant valvular disease
* controindication for Adenosin administration
* previous CABG on the index vessel

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: Cardiologia Interventistica UMG
state: Calabria
Study officials:
References:
Clinical trial NCT01618331: Protein Supplementation and Exercise in Patients With FSH Muscular Dystrophy- a Randomized Placebo Controlled Study
Official title: The Effect of Protein Supplementation Doing Regular Exercise in Patients With Facioscapulohumeral Muscular Dystrophy - a Blinded RCT Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facioscapulohumeral Muscle Dystrophy
Keywords: FSHD
Endurance exercise
Protein supplementation
Placebo RCT
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: The Augustinus Foundation, Denmark.
name: Aase and Ejnar Danielsens Foundation
name: The Danish Rheumatism Association
name: AP Moeller Foundation
First posted: 2012-06-13
Enrollment: 42
Sex: ALL
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 hypotheses is that regular post exercise supplementation increase fitness and daily activity level in patients with Fascioscapulohumeral (FSH) muscular dystrophy.

All patients are tested before and after 12 weeks of cycle-ergometer exercise. Maximal oxygen consumption and 6MWT is used as primarily effect goals. Secondary effect goals are risk of falls and daily activity level.

Detailed description: The purpose of this study is to investigate the response to protein-carbohydrate supplementation doing regular exercise in patients with FSHD. All patients are tested before and after 12 weeks of cycle-ergometer exercise. Maximal oxygen consumption and a functional 6 min walk test(6MWT) is used as primarily effect goals. Secondary effect goals are risk of falls and daily activity level. We measure manuel muscle strength, a balance test, a 5-time-up-and-down-chair-test, a 14 steps-stair-test, accelerometer measuring, daily activity level questionnaire and SP36.

We use a blinded randomized controlled trail. The interventions are 12 weeks regular exercise and consumption of a post-exercise drink. The exercise consists of 30 session of 30 minutes moderate exercise on a cycle-ergometer. After each exercise session patients consume a protein or a non-caloric placebo drink.

Eligibility criteria: Inclusion Criteria:

* Verified FSHD
* Age 18-65
* Untrained. Less than two hours cardio-training each week the last 4 month.

Exclusion Criteria:

* Competitive disorders
* Pregnant and breastfeeding
* Unable to walk 200 m within 6 min.

Primary outcomes:
measure: Maximal oxygen consumption test
timeFrame: up to Week 12
measure: 6MWT
timeFrame: up to Week 12
Secondary outcomes:
measure: Risk of falls
timeFrame: week: 0 and 12
measure: Daily activity level
timeFrame: week: 0 and 12
measure: Blood samples
timeFrame: week: 0, 4, 7, 10, 12
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Neuromuscular Research Unit, Department of Neurology, Rigshospitalet
Study officials:
References:
Clinical trial NCT04083131: Sense of Coherence and Primary Dysmenorrhea in High School Girls in Finistere, France
Official title: Sense of Coherence and Primary Dysmenorrhea in High School Girls in Finistere: Cross-sectional Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Dysmenorrhea
Keywords: Sens of coherence
Primary dysmenorrhea
Salutogenesis
Teenagers
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 255
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: High school girls in Finistère

Brief summary: This study evaluates the relation between sens of coherence and primary dysmenorrhea. Aself-questionnaire is completed by a sample of girls aged between 14 and 19, schooled in Finistère (France).

Detailed description: Primary dysmenorrhea affects more than 60% of adolescent girls. Menstrual pain increases absenteeism and lowers self-esteem and academic performance. Moreover, dysmenorrheal women suffer more depression and anxiety.

Sense of coherence (SOC) is composed of three items:

* comprehensibility: what the person understands about his illness
* manageability: what the person does to cope
* meaningfulness: what the disease means to the person. A high SOC score is related to good mental and physical health. The aim of this study will be to determine if there is a relationship between primary dysmenorrhea and the sense of coherence.

A self-questionnaire composed of the SOC-13 and a scale evaluating dysmenorrhea will be proposed in the voluntary high schools of Finistère (France) to the girls of the classes chosen at random.

Eligibility criteria: Inclusion Criteria:

* student in high schools
* aged 14 and 19 years
* with menstrual cycle

Exclusion Criteria:

* Illiteracy
* student and parents opposition

Primary outcomes:
measure: Presence / absence of dysmenorrhea
timeFrame: Inclusion - Day 0
measure: Sense of coherence
timeFrame: Inclusion - Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Lycée de l'Harteloire
city: Douarnenez
country: France
facility: Lycée Jean-Marie Le Bris
city: Landerneau
country: France
facility: Lycée de l'Elorn
city: Landivisiau
country: France
facility: Lycée du Léon
city: Quimperlé
country: France
facility: Lycée Roz Glas
city: Quimper
country: France
facility: Lycée Brizeux
Study officials:
References:
Clinical trial NCT06519331: Development of a New Method for Liver Stiffness Measurement Using FibroScan
Official title: M148 - Development of a New Method for Liver Stiffness Measurement Using FibroScan
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Liver Diseases
Keywords: FibroScan
Vibration Controlled Transient Elastography
Liver Stiffness Measurement
Lead sponsor: Echosens
Sponsor class: INDUSTRY
First posted: 2024-07-25
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is an European, prospective, interventional, multicenter clinical investigation that will take place in 2 French sites. 114 adults patients will be included. The study objective is to develop a new method for measuring liver stiffness using FibroScan.


Eligibility criteria: Inclusion Criteria:

* Adult patients (≥ 18 years of age) followed in the hepatology or endocrinology department for liver disease, suspected liver disease or consequences of liver disease, all etiologies combined.
* Adult patient able to give his written consent
* Patient affiliated to the French Social Security system

Exclusion Criteria:

* Vulnerable patients
* Patients with liver ascites
* Patients with heart failure

Primary outcomes:
measure: Reduced intra-examination dispersion of liver stiffness measurements with the new measurement method.
timeFrame: 24 months
Secondary outcomes:
measure: Bias between the different stiffness measurements (reference/estimated reference/at rest)
timeFrame: 24 months
measure: Bias between the estimated reference stiffness repetitions and between the stiffness at rest repetitions.
timeFrame: 24 months
measure: Bias between the CAP measured with the Research FibroScan and the CAP measured with the Reference FibroScan
timeFrame: 24 months
measure: Bias between the CAP repetitions done with the Research FibroScan
timeFrame: 24 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière
state: Ile De France
city: Orsay
country: France
facility: Groupe Hospitalier Nord Essonne - Site Paris- Saclay
Study officials:
References:
Clinical trial NCT02922231: Post-Marketing Surveillance (Usage Results Study) of RIXUBIS in Adult and Pediatric Patients With Haemophilia B in South Korea
Official title: Post-Marketing Surveillance (Usage Results Study) of RIXUBIS in Adult and Pediatric Patients With Haemophilia B in South Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia B
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2016-10-04
Enrollment: 57
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hemophilia B in South Korea who have been prescribed RIXUBIS.

Brief summary: Primary: To characterize the safety of RIXUBIS when used under normal clinical care in South Korea.

Secondary: To describe hemostatic effectiveness in subjects receiving RIXUBIS under normal clinical care in South Korea.


Eligibility criteria: Inclusion Criteria:

1. Participants with congenital hemophilia B (FIX level ≤5%)
2. Participant or the participant's legally authorized representative has provided signed informed consent.
3. Participant is indicated for treatment according to the RIXUBIS Korean product leaflet.

Exclusion Criteria:

1. Participants with known hypersensitivity or presence of any contraindication to RIXUBIS or its excipients including hamster protein
2. Participants with Disseminated Intravascular Coagulation (DIC)
3. Participants with signs of fibrinolysis

Primary outcomes:
measure: Number of adverse events (AEs)
timeFrame: Throughout the study period of approximately 2 years and 6 months
Secondary outcomes:
measure: Physician rated effectiveness of RIXUBIS for prophylactic treatment in participants <12 years old
timeFrame: Up to 6 months from baseline while on treatment
measure: Participant rated effectiveness of RIXUBIS for prophylactic treatment in participants ≥12 years old
timeFrame: Up to 6 months from baseline while on treatment
measure: Physician rated effectiveness of RIXUBIS for on-demand treatment in participants <12 years old
timeFrame: Up to 6 months from baseline while on treatment
measure: Participant rated effectiveness of RIXUBIS for on-demand treatment in participants ≥12 years old
timeFrame: Up to 6 months from baseline while on treatment
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daejeon
country: Korea, Republic of
facility: DaeJeon Eulji University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Chung Hospital
city: Seoul
country: Korea, Republic of
facility: Kim Hugh Chul Internal Medicine
city: Seoul
country: Korea, Republic of
facility: Korea Hemophilia Foundation
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01849731: Effectiveness of Two Interventions in Patients With Low Educational Level With Diabetes to Reduce Inequalities in Self-care Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type 2
Keywords: Diabetes Mellitus type 2;
Primary Care, healthcare inequalities;
Diabetes self-management,
Quality of diabetes care
Lead sponsor: Andalusian School of Public Health
Sponsor class: OTHER_GOV
First posted: 2013-05-08
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this cluster randomized trial is to determine whether an intervention implemented in a General Surgery, based in improving patient-provider communication, results in a better diabetes self-management in patients with lower educational level. A secondary objective is to assess whether telephone reinforcement enhances the effect of such intervention.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of DM2,
* Over 18 years,
* Low educational level (no college to GBS or ESO),
* Inadequate glycemic control (glycosylated hemoglobin levels above 7%)

Exclusion Criteria:

* Physical or mental condition that prevents the completion of the intervention - complications arising from severe DM2 altering routine medical monitoring.

Primary outcomes:
measure: Glycosylated Haemoglobin levels
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Andalussian School of Public Health
Study officials:
References:
citation: Ricci-Cabello I, Olry de Labry-Lima A, Bolivar-Munoz J, Pastor-Moreno G, Bermudez-Tamayo C, Ruiz-Perez I, Quesada-Jimenez F, Moratalla-Lopez E, Dominguez-Martin S, de los Rios-Alvarez AM, Cruz-Vela P, Prados-Quel MA, Lopez-De Hierro JA. Effectiveness of two interventions based on improving patient-practitioner communication on diabetes self-management in patients with low educational level: study protocol of a clustered randomized trial in primary care. BMC Health Serv Res. 2013 Oct 23;13:433. doi: 10.1186/1472-6963-13-433.