louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03409588: Treatment of Exercise-Induced Pulmonary Vascular Dysfunction After Pulmonary Thromboendarterectomy or Balloon Pulmonary Angioplasty
Official title: Treatment of Exercise-Induced Pulmonary Vascular Dysfunction in Symptomatic Patients After Pulmonary Thromboendarterectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Thromboembolic Disease (CTED)
Exercise Intolerance Post PEA Surgery
Keywords: Chronic Thromboembolic Disease
CTED
Treatment Post PEA surgery
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2018-01-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open label study of Riociguat in patients with continued exercise intolerance at least 6 months following pulmonary endarterectomy (PEA).


Eligibility criteria: Inclusion Criteria:

* Adult patients who underwent PTE or BPA for Chronic thromboembolic pulmonary hypertension (CTEPH) at least six months prior to screening and report ongoing subjective exercise limitation,
* able to give consent
* able to perform a exercise protocol

Exclusion Criteria:

* Patients with known Residual Pulmonary Hypertension (RPH) by RHC following PTE for CTEPH
* ongoing PAH-specific vasodilator therapy
* known contraindication to riociguat
* a physical limitation to completing an exercise protocol

Primary outcomes:
measure: Change in mean pulmonary arterial pressure
timeFrame: Baseline and 3 months
measure: Change in cardiac output
timeFrame: Baseline and 3 months
measure: Change in Pulmonary artery compliance
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Change in 6 minute walk test
timeFrame: Baseline and 3 months
measure: Change in New York Heart Association (NYHA) functional class
timeFrame: Baseline and 3 months
measure: Change in the University of California San Diego (UCSD) shortness of Breath Score
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado, Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Todd Bull, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Peter Sottile, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: William Cornwell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02357888: Assessment of V0018 2.5 mg Effect on Craving
Official title: Double-blind, Randomized, Placebo-controlled, Cross-over Study of the Effect of a 2.5 mg Nicotine Lozenge on Smoking Craving
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy Highly Dependant Smokers
Keywords: Nicotine replacement therapy
craving
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
First posted: 2015-02-06
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the reduction of craving and its time course after administration of V0018 2.5 mg compared to placebo in healthy highly dependant smokers.


Eligibility criteria: Inclusion Criteria:

* Male and female aged 18 to 64 years
* Smoking ≥ 20 cigarettes/day continuously for the last two years
* With a first cigarette smoked within 30 min after waking
* Not currently in the process of quitting smoking

Exclusion Criteria:

Related to pathologies

* Current or recurrent buccal lesions which, in the opinion of the investigator, would interfere with the assessment of the different parameters
* Hyposalivation or asialia
* Intolerance to lactose, or any pathology that could cause endogenous production of carbon monoxide (CO)

Related to treatments

* Use of antidepressants within the last three months
* Use of sedatives, hypnotics, tranquilizers or any other addictive agents within the last 3 months
* Routine use of tobacco other than cigarettes
* Regular use for more than one week of any treatment for smoking cessation (gum, patch, inhaler, lozenge, tablet, bupropion, varenicline) and other smokeless tobacco products (including e-cigarettes) within three months
* History of hypersensitivity to nicotine, peanut, soya or to any of the excipients of study treatment
* Intolerance to fructose
* History of phenylketonuria (aspartame)

For women of childbearing potential:

* Is pregnant or in post-partum period or a nursing mother

Primary outcomes:
measure: Questionnaire for Smoking Urges Brief (QSU-Brief) (10 items)
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Gieres
country: France
Study officials:
affiliation: Pierre Fabre Medicament
name: Françoise MD TONNER
role: STUDY_DIRECTOR
References:
Clinical trial NCT01303588: Yoga and Qigong for Elderly Patients With Chronic Low Back Pain
Official title: Yoga and Qigong for Elderly Patients With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Low Back Pain
Keywords: elderly patients
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2011-02-25
Enrollment: 176
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate whether yoga or qigong therapy is effective in treating low back pain in elderly patients compared to no therapy (waiting list control). The secondary aim is to compare yoga and qigong.


Eligibility criteria: Inclusion Criteria:

* Men and women ≥ 65 years of age
* Chronic low back pain since 6 months at least
* Functional Rating Index (FRI) ≥ 2 last 7 days
* Informed consent form signed

Exclusion Criteria:

* Disc prolapse with acute neurological symptoms
* Previous spinal operations
* Severe organic or psychiatric disease conditions, not allowing to participate in the trial
* Use of opioids
* Drug- and alcohol-addiction
* Participation in another clinical trial within the last 6 months
* Participation in yoga or qigong training within the last 12 months
* Planned physical therapy within study duration

Primary outcomes:
measure: Functional rating Index (FRI)
timeFrame: 3 months
Secondary outcomes:
measure: Functional Rating Index
timeFrame: 6 months
measure: Visual Analogue Scale
timeFrame: 3, 6 months
measure: FFb-HR
timeFrame: 3, 6 months
measure: Pain medication
timeFrame: 6 months
measure: Falls
timeFrame: 6 months
measure: Tinetti Test
timeFrame: 3, 6 months
measure: SF 36
timeFrame: 3, 6 months
measure: Geriatric Depression Scale
timeFrame: 3, 6 months
measure: Adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité University Berlin, Institute for Social Medicine, Epidemiology, Health Economics
Study officials:
References:
Clinical trial NCT01589588: Administration of Oxygen to Cluster Headache Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cluster Headache Attacks
Keywords: acute treatment
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2012-05-02
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will investigate the possible difference in treatment effect between three different oxygen delivery systems in the acute treatment of cluster headaches.


Eligibility criteria: Inclusion Criteria:

* episodic cluster headache
* regular occurance of attacks and cluster for 2 years
* 2-8 attacks / day
* cluster periods of over 14 days
* duration of current cluster period max 14 days
* ability to differentiate between attacks of CH and other forms of headache

Exclusion Criteria:

* Changes in prophylactic treatment a week before trial
* pregnancy or breastfeeding women
* serious somatic or psychiatric disease
* COLD
* chronic or primary or secondary headache \> 14 days / month other than CH
* alcohol abuse

Primary outcomes:
measure: Efficacy
timeFrame: 15 minutes
Secondary outcomes:
measure: Mask preference
timeFrame: 2 days
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Headache Center
Study officials:
References:
Clinical trial NCT06511388: Cardiotoxic Effects of Chemotherapy in Patients With Sarcomas: A Two and Three-dimensional Echocardiographic Speckle Tracking Imaging Study
Official title: Cardiotoxic Effects of Chemotherapy in Patients With Sarcomas: A Two and Three-Dimensional Echocardiographic Speckle Tracking Imaging Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sarcoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosis of sarcoma undergoing chemotherapy treatment

Brief summary: This study is being done to identify markers that will allow researchers to identify in advance patients with sarcomas who are at highest risk for developing heart failure related to chemotherapy.

Detailed description: PRIMARY OBJECTIVES:

I. To detect acute and subacute changes in myocardial function by two-dimensional (2D)-Speckle Tracking Echocardiography (STE) derived strain and strain rate in sarcoma patients undergoing chemotherapeutic treatment.

Ia. To compare 2D-STE and three-dimensional (3D)-STE derived strain and strain-rate; Ib. To compare 2D-STE and 2D- and 3D-left ventricle ejection fraction (LVEF); Ic. If feasible, to compare 2D-STE and cardiac biomarkers \[serum cardiac troponin T and N-terminal fragment of brain natriuretic peptide (NT-proBNP)\].

II. To predict chemotherapy-induced cardiotoxicity by using 2D-STE and/or other significant parameters for early detection of cardiac dysfunction.

OUTLINE: This is an observational study.

Patients receive anthracycline once a day or split between 2-3 days per standard of care (SOC). Patients undergo 2D-STE throughout the study and have their medical records reviewed on study.

Eligibility criteria: Inclusion Criteria:

* Patients followed at Mayo Clinic and treated for sarcoma with doxorubicin as first-line treatment

Exclusion Criteria:

* First-line treatment not including doxorubicin

  * Treatment performed outside of Mayo Clinic with different protocols
  * Age \< 18 years

Primary outcomes:
measure: Changes in myocardial function - 2D-STE
timeFrame: Baseline, 3 months, 6 months, 1 year
measure: Changes in myocardial function - 2D-STE vs 3D-STE
timeFrame: Baseline, 3 months, 6 months, 1 year
measure: Changes in myocardial function - 2D-STE vs 2D-LVEF and 3D-LVEF
timeFrame: Baseline, 3 months, 6 months, 1 year
measure: Changes in myocardial function - 2D-STE vs cardiac biomarkers
timeFrame: Baseline, 3 months, 6 months, 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Hector R. Villarraga, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05137288: Intrathecal Atropine Versus Intravenous Ondasetron in Post Operative Nausea Due to Intrathecal Morphine
Official title: Intrathecal Atropine Versus Preoperative Intravenous Ondasetron for Prevention of Postoperative Nausea and Vomiting Due to Intrathecal Morphine in Perineal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Perineal Surgery
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-11-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare between intrathecal atropine versus preoperative administration of IV ondansetron in decreasing incidence of post operative nausea and vomiting related to intrathecal opioids in post operative period in perineal surgery as regard : efficacy and side effects .


Eligibility criteria: Inclusion Criteria:

* Age between ( 18 - 45 ) years.
* Body mass index between ( 18.5 - 35 )
* patients undergoing perineal surgery as anal fissure , piles and rectocele
* patients receiving bupivacaine ( 20 mg / 4 ml ) as spinal anesthesia
* Patinets with physical status 1 or 2 according to ASA classification

Exclusion Criteria:

* Patient refusal .
* Any contraindication of neuraxial block as : coagulopathy , skin infection at injection site or bacteremia , hypovolemia and shock , history of allergy to L.A , sever aortic stenosis or mitral stenosis ......... etc
* Patients with physical status other than 1 and 2 according to ASA classification
* Those with history of nausea and vomiting , also those who received anti emetic drugs in last 2 hours of operation .
* Allergy to any of the drug included in this study .

Primary outcomes:
measure: frequency of attacks of postoperative nausea and vomiting
timeFrame: 6-9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Gybels J, Erdine S, Maeyaert J, Meyerson B, Winkelmuller W, Augustinsson L, Bonezzi C, Brasseur L, DeJongste M, Kupers R, Marchettini P, Muller-Schwefe G, Nitescu P, Plaghki L, Reig E, Spincemaille G, Thomson S, Tronnier V, Van Buyten JP. Neuromodulation of pain. A consensus statement prepared in Brussels 16-18 January 1998 by the following task force of the European Federation of IASP Chapters (EFIC). Eur J Pain. 1998;2(3):203-9. doi: 10.1016/s1090-3801(98)90016-7. No abstract available.
citation: Baciarello M, Cornini A, Zasa M, Pedrona P, Scrofani G, Venuti FS, Fanelli G. Intrathecal atropine to prevent postoperative nausea and vomiting after Cesarean section: a randomized, controlled trial. Minerva Anestesiol. 2011 Aug;77(8):781-8.
Clinical trial NCT01623388: Epigenetic Modifications of Diabetes Mellitus Type I
Official title: Epigenetic Modifications Induced by Glycemic Variability
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Type I Diabetes
Lead sponsor: Scripps Translational Science Institute
Sponsor class: OTHER
First posted: 2012-06-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type I Diabetic

Brief summary: This research is being done to find out if significant changes in blood glucose cause bad outcomes in patients with diabetes.


Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* Diagnosis of Type I diabetes
* Willing to wear continuous blood glucose monitor as specified in protocol

Exclusion Criteria:

* Pregnant or planning to become pregnant during the study

Healthy control group Inclusion:

* 18-65 years old
* Willing to wear continuous blood glucose monitor as specified in protocol

Exclusion:

* Pregnant or planning to become pregnant during the study
* Diagnosis of Type I or II Diabetes

Primary outcomes:
measure: Evaluate blood sugar variability in Type I diabetics for differences in epigenetic signatures between Type I diabetics with little glycemic variability as compared to those with more pronounced glycemic changes.
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Scripps
state: California
Study officials:
References:
Clinical trial NCT03361488: Effect of Structured Patient Interviews in the Preoperative Anesthesia Clinic on Recall of Relevant Information
Official title: Effect of Structured Patient Interviews in the Preoperative Anesthesia Clinic on Recall of Relevant Information
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Surgical Procedure, Unspecified
Communication
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The preanesthetic visit influences patient satisfaction and medical outcome. This study aims to evaluate whether training for a structured interview technique improves communication skills, resulting in increased recall of relevant information by surgical patients.


Eligibility criteria: Inclusion Criteria:

* Surgical patients in the preoperative anesthesia clinic
* Written informed consent

Exclusion Criteria:

* Inadequate comprehension of the German language

Primary outcomes:
measure: Recall of information
timeFrame: Immediately after patient interview
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Nicolai Goettel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Basel, Switzerland
name: Albert Urwyler, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04969588: Kinect Equations for Body Indices and Body Composition
Official title: Development and Validation of Kinect Equations to Estimate Body Indices and Body Composition
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anthropometry
Body Composition
Keywords: Anthropometry
Body Composition
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2021-07-20
Enrollment: 240
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Apparently healthy participants aged 6-65 years are recruited for this study within 3 years. Estimated enrolled number are 240. Eligible participants will visit study site once and take the measurements.

Brief summary: This perspective observational study will recruited 240 participants for investigating the feasibility of using Microsoft Azure Kinect developer kit as a method for body indices and body composition. Reference methods will be dual energy X-ray absorptiometry and bioelectrical impedance analysis.

Detailed description: The purpose of this research is to validate the precision and accuracy of Microsoft Azure Kinect Developer Kit in the application of body anthropometric index and body composition measures. This study assumes that depth camera along with skeletal tracking package can estimate the 3D joint position and skeletal length. A dual energy X-ray absorptiometry scanner, a medical device with a daily background dose of radiation will be used as the gold standard.

This study aims to investigate the correlation and agreement of using Kinect in estimating skeletal length and body composition in human.A total of 240 participants including children and adults will be recruited for measurements in a 3-year period.

Eligibility criteria: Inclusion Criteria:

* Healthy children and adult
* Age 6-65 years

Exclusion Criteria:

* Chronic illness or chronic medication use (\> 3 months)
* Pregnant
* Metal implant(s) or splint(s)
* Pacemaker implantation
* Limb defect(s) or injury

Primary outcomes:
measure: Assess association and agreement in body indices and body composition between Kinect and standard methods.
timeFrame: 36 months
measure: Develop and validate Kinect equations to predict body indices and body composition.
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chiayi City
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital, Chiayi, Taiwan
name: Li-Wen Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02296788: Effects of Aerobic Exercise on Gut Microbiota
Official title: Effects of Aerobic Exercise on Gut Microbiota (EGM) - P & F Ancillary Study (E-Mechanic)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gut Microbiota
Keywords: Gut Microbiota
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In the present study, we seek to elucidate the effects of aerobic exercise on fecal microbiota following the aforementioned no exercise control group and two doses of aerobic exercise training (the exercise training spans \~24 wks) in a cross-sectional sample.

Detailed description: We will collect ancillary data for the ongoing Examination of Mechanisms of exercise-induced weight compensation (E-Mechanic; RCT; Martin CK and Church TS Co-PI's; R01 HL 102166) to investigate the independent aim and hypothesis of this pilot and feasibility (P \& F) grant examining if there are differences in colonic microbial populations from a fecal sample following supervised and controlled aerobic exercise.

The proposed study seeks to better understand the role of colonic microbial populations as a mechanism of change in body weight during aerobic exercise. E-Mechanic is examining the effects of 2 tightly controlled and supervised doses of aerobic exercise, and a no-exercise control group, on energy balance and body weight over 24 wks in overweight and obese persons. The two aerobic exercise doses were: 1) 8 kcal/kg of body weight/week (KKW) (\~900 kcal/wk) and 2) 20 KKW (\~2250 kcal/wk) compared to a no exercise control group. The low dose of exercise (8 KKW) represents the American College of Sports Medicine (ACSM) recommendation for overall health and the higher dose (20 KKW) the recommendation for weight loss and weight loss maintenance.

Aim 1 To investigate if colonic bacterial populations differ between the exercise groups and the healthy living control group following aerobic exercise.

It is hypothesized that participants in the exercise group will have different bacterial populations than those in the healthy living control group.

Eligibility criteria: Inclusion Criteria:

Participants are overweight or obese (BMI 25 ≥ kg/m2 and ≤ 45 kg/m2), not actively exercising \> 20 min on ≥ 3 days/wk, weight stable, non-diabetic, non-smoker, and not have any major medical disorders including such as HIV, CVD, mental illness

Primary outcomes:
measure: Gut Microbiota
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: