louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00333905: The Effect of Ischemic Training on Exercise Endurance
Official title: The Effect of Ischemic Training on Exercise Endurance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Congestive Heart Failure
Cardiovascular Disease
Keywords: Exercise
Exercise Therapy
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2006-06-06
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 71
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if reducing blood flow to an exercising muscle during exercise training will enhance the training effect on that muscle in people who have limited exercise because of congestive heart failure

Detailed description: The objective of this study is to determine whether reduction of blood flow during stair-stepping and cycling ergometer leg exercise will contribute to an improvement in whole body exercise capacity or submaximal exercise endurance in patients with mild congestive heart failure. Two groups of 25 patients with mild to moderate CHF, aged 30-70, will be trained for 12 weeks. The experimental group will train with pressure cuffs inflated on one thigh and lower leg during exercise. The cuff will be applied on alternate legs during training, such that each leg has the same duration of ischemic training. The control group will train for a similar duration and intensity without pressure cuffs on the legs. Pre and post training measures will include VO2peak, exercise duration at 30% VO2peak, 6 minute walk test, Minnesota Living with Heart Failure questionnaire

Eligibility criteria: Inclusion Criteria:

* Mild Congestive Heart Failure
* Must be able to exercise

Exclusion Criteria:

* Venous or arterial thrombus
* Lower extremity arthritis
* Blood clotting abnormalities
* Claudication
* Peripheral vascular disease
* Evidence of deep vein thrombosis on ultrasound

Primary outcomes:
measure: Exercise duration before and after 12 weeks of training during a submaximal exercise test and distance walked on a 6-minute walk test.
Secondary outcomes:
measure: Peak cycle ergometer VO2max test before and after training
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: New Mexico VA Health Care System
state: New Mexico
Study officials:
affiliation: Cardiology Division Chief, Medicine Service VAMC Albuquerque (501) Albuquerque, NM
name: Milton V Icenogle, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Loeppky JA, Gurney B, Kobayashi Y, Icenogle MV. Effects of ischemic training on leg exercise endurance. J Rehabil Res Dev. 2005 Jul-Aug;42(4):511-22. doi: 10.1682/jrrd.2004.06.0069.
Clinical trial NCT04614805: Timely Reperfusion in Acute ST-segment Myocardial Infarction
Official title: Mobilizing Clinical Leadership to Achieve Timely Reperfusion in Acute ST-segment Elevation Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 146
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients diagnosed with STEMI in our regional health trust during the study period who has an indication for immediate reperfusion therapy

Brief summary: The aim of the study is to monitor outcomes, especially time to reperfusion, in ST-elevation acute myocardial infarction patients.

Detailed description: In the regional health trust of North Norway, time to reperfusion in acute ST-elevation myocardial infarction is below the national average and below recommendations. The aim of this study is to monitor outcomes, especially time to reperfusion, in ST-elevation acute myocardial infarction patients. The study period is supposedly lasting for approximately 4 months, the time estimated to observe the clinical course of 100 patients. Before and during the study period, clinical leaders are encouraged to improve guideline adherence and to closely monitor the results of their own and collaborating institutions.

Eligibility criteria: Inclusion Criteria:

* Patient diagnosed with acute myocardial infarction with ST-elevations within our regional health trust during Nov 1st and for approx 4 months, and with an indication for reperfusion therapy (thrombolysis and/pr PCI)

Exclusion Criteria:

* Reperfusion therapy not indicated or contraindicated

Primary outcomes:
measure: Time to reperfusion
timeFrame: This parameter will be recorded within 1 week after patient inclusion
Secondary outcomes:
measure: Ejection fraction at discharge
timeFrame: This parameter will be recorded up to 6 months after patient inclusion
measure: Survival
timeFrame: This parameter will be collected from patient's records during Nov -20 till Aug -21.
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital North Norway
state: Troms Og Finnmark
Study officials:
References:
citation: Bartnes K, Albrigtsen H, Iversen JM, Brovold H, Moller NH, Wembstad B, Arstad F, Kristensen AH, Cortis J, Olsen SJ, Nygaard SNS, Kindler SG, Moe O, Hansen C, Mannsverk JT. The Barriers to Rapid Reperfusion in Acute ST-Elevation Myocardial Infarction. Cardiol Ther. 2022 Dec;11(4):559-574. doi: 10.1007/s40119-022-00281-7. Epub 2022 Oct 6.
Clinical trial NCT06276205: Vitamin D & Levothyroxine Combination Versus Levothyroxine on Lipid Profile in Hypothyroidism
Official title: To Compare the Effectiveness of Vitamin D & Levothyroxine Combination Therapy and Levothyroxine Alone on Serum Lipid Profile in Patients With Hypothyroidism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypothyroidism Primary
Lipid Disorder
Dyslipidemias
Keywords: levothyroxine
Vitamin D
Lipids
Hypothyroidism
Dyslipidemia
Lead sponsor: King Edward Medical University
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 62
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to study the improvement of lipid levels in hypothyroid individuals after staring treatment.

The main question it aims to answer is:

• whether adding Vitamin D to standard therapy has any additional benefits

Participants will be given Vitamin D in replacement doses according to their pre-existing Vitamin D level in addition to levothyroxine.

Researchers will compare them with another group receiving only levothyroxine to see how much lipids improve in them


Eligibility criteria: Inclusion Criteria:

* Patients of all genders.
* Age more than 12 years
* Biochemically hypothyroid (overt \& subclinical)
* Vitamin D level between 10-70ng/ml
* TC \<250mg/dl, LDL 70-144mg/dl, TGs 150-499mg/dl

Exclusion Criteria:

* Known Atherosclerotic Cardiovascular Disease
* BMI\>35kg/m2
* History of Alcoholism (\>14 units/day)
* History of Beta blocker intake
* Patient taking lipid lowering drugs

Primary outcomes:
measure: Decline in Total Cholesterol
timeFrame: 24 weeks
measure: Decline in LDL
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: King Edward Medical University
state: Punjab
Study officials:
References:
Clinical trial NCT04193605: Feasibility of the Mindfulness-Based Stress Reduction Intervention for Black Women Living With HIV
Official title: Feasibility of the Mindfulness-Based Stress Reduction Intervention for Black Women Living With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Health Behavior
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2019-12-10
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The investigator propose to culturally adapt the mindfulness-based stress reduction (MSBR) intervention for Black/African American women living with HIV (WLWH) to reduce stress and enhance HIV self-care behaviors and viral load (VL) suppression, which has the potential to attenuate prominent racial and gender disparities experienced by Black WLWH in the US. Specifically, the investigator aims to 1) culturally adapt the MBSR intervention for Black WLWH using ADAPT-ITT; 2) pre-pilot the adapted intervention via an open non-randomized pilot study to further refine the culturally adapted intervention; and 3) conduct a 2-armed randomized pilot test of the behavioral intervention compared to standard of care to assess the feasibility and acceptability the adapted MBSR intervention for Black WLWH. The investigator hypothesis that the adapted intervention will be feasible and acceptable to member of the target population.


Eligibility criteria: Inclusion Criteria:

* Cisgender females
* HIV seropositive
* 18 years of age or older
* English speaking
* An active patient at the local HIV ambulatory clinic in Alabama.

Exclusion Criteria:

* Non-English speaking
* Appear temporarily impaired (e.g., intoxicated)
* Not willing to or legally unable to provide informed consent.

Primary outcomes:
measure: Feasibility Intervention Measure
timeFrame: Immediately after the intervention(which consists of an orientation followed by eight weekly sessions, consistent with MSBR interventions), the measure was collected within one week of completing the final session.
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB School of Nursing
state: Alabama
Study officials:
References:
Clinical trial NCT05145205: Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass
Official title: Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss in Patients With Morbid Obesity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laparoscopic Surgery
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2021-12-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study included Egyptian patients with age ranging from 18 to 70 seeking surgical operation for obesity.

Brief summary: This is a retrospective work on 200 morbid obese patients randomized and categorized into 2 groups according to the treatment method: the laparoscopic sleeve gastrectomy (LSG) and LRYGB groups, within the period from 2014 to 2019 and matched weight dissipation, complications, life quality, and negative events


Eligibility criteria: Inclusion Criteria:

* All patients of (Body Mass Index) more than 40, with at least 1 comorbidity

Exclusion Criteria:

* All patients of (Body Mass Index) less than 40,
* No comorbidities
* Patients who refused the surgical procedures.

Primary outcomes:
measure: weight dissipation
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Azhar faculty of medicine
Study officials:
References:
Clinical trial NCT04131998: Albanian Versions and Validation of Visual Analogue Scale, Back Pain and Autonomy Questionnaires
Official title: Develop and Validation of Visual Analogue Scale, Back Pain Disability and Autonomy Questionnaires in Albanian Language
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Back Pain
Pain, Acute
Disability Physical
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 200
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Albanian citizens with back pain and with autonomy problems who follows rehabilitation sessions in a rehabilitation center.

Brief summary: A total of 200 participants are predicted to be enrolled for completing questionnaires in relation of visual analogue scale, back pain disability and autonomy in Albania. A feasibility, validate, test-retest reliability and observational design is estimated.

Detailed description: This study consist of two parts, firstly translation and cross-cultural adaptation of pain and automaton questionnaires into albanian language and secondly psychometric evaluation of the questionnaires including test-retest reliability in Albanian health care centers/ hospitals .

Eligibility criteria: Inclusion Criteria:

* back pain
* orthopedic problems
* Albanian citizens
* rehabilitation center patients

Exclusion Criteria:

* neurological patients
* no native albanian language

Primary outcomes:
measure: Visual Analogue Scale (VAS) of pain
timeFrame: 7 days
measure: Roland-Morris Questionnaire (RMQ) for athletes physical disability
timeFrame: 7 days
measure: Barthel Index (BI) of patients autonomy
timeFrame: 7 days
measure: Oswestry Disability Index
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Orges Lena
state: España
Study officials:
affiliation: UCAM Universidad Catolica de Murcia
name: Jasemin Todri, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05768698: Assessment of Left Ventricular Filling Pressure by Applying Artificial Intelligence Algorithms to Left Atrial Speckle-tracking Echocardiography
Official title: Valutazione Delle Pressioni di Riempimento Del Ventricolo Sinistro Attraverso l'Impiego di un Software di Intelligenza Artificiale Applicato Alla Stima Dello Strain Atriale Sinistro Con Ecocardiografia Speckletracking: Studio di Validazione Mediante Cateterismo Cardiaco
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure, Diastolic
Echocardiography
Keywords: Transthoracic echocardiography
left ventricular filling pressure
artificial intelligence
right heart catheterization
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
Collaborators: name: Philips Healthcare
First posted: 2023-03-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients referred to our cath lab for clinically indicated coronary angiography or right heart catheterization for the diagnosis of dyspnea

Brief summary: The goal of this single-center, prospective, observational study is to validate a software package based on an artificial intelligence algorithm for automated non-invasive estimation of LVFP against invasively measured ones by left and right heart catheterization; In addition, the added value of this new automated software to detect increased LVEDP \> 15 mm Hg compared to the current ASE/EACVI algorithm for assessing diastolic dysfunction and longitudinal left atrial strain during the reservoir phase will be evaluated.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 yo,
* Signed informed consent to be part of this study,
* No pregnancy,
* Good acoustic window and patient cooperation to obtain good 2- and 3-dimensional datasets focused on left atrium (LA),

Exclusion Criteria:

* Unwillingness to be part of the study,
* Patients with poor 2-dimensional imaging quality in ≥ 1 LA segment or lacking of a discernible R-R interval, which might preclude accurate strain measurements,
* Patients with more than mild mitral valve heart disease, aortic regurgitation, left side valvular prosthesis or mitral valve repair, mitral annulus calcification (≥ 5 mm),
* Patients with history or presence of atrial fibrillation (AF), supraventricular arrhythmias, ventricular paced rhythm, left bundle branch block (LBBB),
* Patients taking diuretics or vasodilators (nitrates) on the day of the examination, which could alter loading conditions.

Primary outcomes:
measure: Left ventricular filling pressure
timeFrame: During procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Andover
country: United States
facility: Philips Healthcare
state: Massachusetts
Study officials:
References:
Clinical trial NCT04585698: QST, Blink Reflex and Nociceptive Flexion Reflex in Headache
Official title: Quantitative Sensory Testing, Blink Reflex and Nociceptive Flexion Reflex in the Pathophysiology of Headache
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Head Pain
Keywords: headache
fremanezumab
blink reflex
nociceptive flexion reflex
quantitative sensory testing
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with headache before and 1 month after receiving fremanezumab

Age: 18-65 years

Sex: 2/3 female, 1/3 male

Brief summary: The aim of this study is to compare central and peripheric sensitization in headache patients at Baseline (T0) and 1 month after (T1) a treatment with an anti-CGRP (Fremanezumab-Ajovy).

Detailed description: 20 patients and 20 healthy subjects will be enrolled. The headache patients will be recruited just before starting their treatment and 1 month after (corresponding to the efficacy peak). Hot and cold stimulations will be delivered with the ATS probe from the Medoc Pathway on the forehead and on the hand (palmar face) to determine painful threshold to warm/cold stimuli. A blink reflex will be generated with a concentric electrode placed over the eyebrow and with active/earth electrodes linked to the EMG machine for the recording. For the nociceptive flexion reflex, a cutaneous stimulation will be applied on the arm and the response recorded on the corresponding muscles.

Eligibility criteria: Inclusion Criteria: patients with headache which are about to receive a treatment with fremanezumab

Exclusion Criteria:

* medication changes 1 month prior to the test
* neuropathy
* acute or chronic pain
* medications having effects on the central nervous system
* other disease

Primary outcomes:
measure: modulation of pain threshold by fremanezumab
timeFrame: one year
measure: modulation of pain threshold by fremanezumab
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01840098: Leucine and Beta-hydroxy-beta-methylbutyrate (HMB) as Anabolic Nutrients After 36 Hours of Fasting
Official title: Leucine and Beta-hydroxy-beta-methylbutyrate (HMB) as Anabolic Nutrients After 36 Hours of Fasting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fasting
Metabolism
Nutrition Support
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2013-04-25
Enrollment: 8
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate metabolic effects of 3 different nutritional compounds.

Fasting (36 hours) creates a catabolic state that is comparable with the catabolic state seen in acute illness.

This study is a randomized, placebo cross-over study investigating 8 healthy men on 4 separated days (at least 3 weeks between trials).

* High leucine content drink
* Low leucine content drink
* Low leucine content drink + HMB
* Carbohydrate (isocaloric)

The investigators hypothesize that these nutritional supplements may counteract catabolic processes in different ways and degrees.


Eligibility criteria: Inclusion Criteria:

* male gender
* 20\<BMI\<30
* Age \> 20 years old
* Written consent before starting the study

Exclusion Criteria:

* Allergy for soya products ore egg
* Diabetes
* Epilepsy
* Infection
* Immune defects
* Heart disease
* Dysregulated hypertension
* Participating in other trials using radioactive tracers or x-rays the last year.

Primary outcomes:
measure: Protein metabolism after 36 hours fasting receiving different nutritional supplements.
timeFrame: 3 control period followed by 4 hours of nutritional drink intake
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Department of Internal Medicine and Endocrinology, Aarhus Universitetshospital
Study officials:
References:
citation: Rittig N, Bach E, Thomsen HH, Moller AB, Hansen J, Johannsen M, Jensen E, Serena A, Jorgensen JO, Richelsen B, Jessen N, Moller N. Anabolic effects of leucine-rich whey protein, carbohydrate, and soy protein with and without beta-hydroxy-beta-methylbutyrate (HMB) during fasting-induced catabolism: A human randomized crossover trial. Clin Nutr. 2017 Jun;36(3):697-705. doi: 10.1016/j.clnu.2016.05.004. Epub 2016 May 25.
Clinical trial NCT05938998: Social Support and Stress Reduction for Caregivers of Young Adults With IDD
Official title: Social Support and Stress Reduction for Caregivers of Young Adults With IDD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burden, Caregiver
Keywords: Caregiver
Down syndrome
Intellectual Disability
Parent
Stress
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study is to evaluate the feasibility and stress reduction impacts of a yoga and support group intervention on caregivers of individuals with intellectual and developmental disabilities.

Detailed description: This is a single arm longitudinal trial. We will recruit up to 40 caregivers of young adults with intellectual and developmental disabilities (IDD). This is a 12-week social support, resources, and stress reduction intervention delivered in person to a group of caregivers of young adults IDD. Participants will be asked to attend one 2 hour group session each week. All sessions will have a 1-hour discussion on resources and social support and 1-hour of yoga. All yoga sessions will be taught by 200 Registered Yoga Teacher certified instructors. Outcome assessments will be collected at baseline and after the 12-week intervention.

Eligibility criteria: Inclusion Criteria:

* 1) caregiver of a young adult with IDD 2) self-reported ability to participate in a yoga class with no contraindications to participation.

Exclusion Criteria:

* 1) Actively participating in another health lifestyles interventional research study.

Primary outcomes:
measure: Recruitment
timeFrame: Baseline
measure: Session Attendance
timeFrame: Weeks 1-12 of intervention
measure: Retention
timeFrame: Weeks 1-12 of intervention
measure: Acceptability
timeFrame: Between Weeks 12-14
Secondary outcomes:
measure: The Perceived Stress Scale
timeFrame: Change from baseline to 12 weeks
measure: ug/dL Salivary cortisol
timeFrame: Change from baseline to 12 weeks
measure: The Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: Change from baseline to 12 weeks
measure: Modified Caregiver Strain Index
timeFrame: Change from baseline to 12 weeks
measure: The Family Empowerment Scale
timeFrame: Change from baseline to 12 weeks
measure: The Pittsburgh Sleep Quality Index
timeFrame: Change from baseline to 12 weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Amy Bodde, PhD
role: PRINCIPAL_INVESTIGATOR
References: