louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01633632: Hatha Yoga for Smoking Cessation
Official title: Hatha Yoga as an Adjunct to Cognitive Behavioral Therapy for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Smoking cessation
Yoga
Cognitive behavioral therapy
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2012-07-04
Enrollment: 67
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether Hatha Yoga can improve the chances of a successful smoking quit attempt.

Detailed description: While many smoking cessation interventions have been studied, even the most successful interventions result in less than 40% abstinence from smoking at 6 months. Most people attempt to quit multiple times before maintaining long-term abstinence from tobacco. Research into interventions to improve quit rates and decrease smoking prevalence is a high priority for multiple organizations. Yoga is an attractive non-pharmacological option because it can be used safely during pregnancy and lactation, can be combined with other pharmacologic and non-pharmacologic treatments, and can be continued well past the smoking cessation date to combat withdrawal symptoms and cravings. There is a critical need for innovative and effective methods for tobacco control that focus on both prevention and cessation.

This project will be broken into two stages. The first stage will aim to pilot test yoga techniques for feasibility and acceptability. Recruitment and retention strategies will be tested and participant satisfaction will be evaluated. Preliminary measures of smoking abstinence and withdrawal symptoms will be conducted.

The second stage of this study will be a randomized trial to compare smoking abstinence with cognitive behavioral therapy (CBT), CBT + yoga, or yoga alone.

Eligibility criteria: Inclusion Criteria:

* Age 19 years or older
* Smoker of 5 or more cigarettes per day
* Willing and physically able to participate in yoga
* Not currently practicing Hatha yoga.

Exclusion Criteria:

* Use of smokeless tobacco

Primary outcomes:
measure: Point prevalence abstinence from smoking
timeFrame: End of intervention (week 7)
Secondary outcomes:
measure: Abstinence from smoking
timeFrame: 3 and 6 months
measure: Change in weight
timeFrame: End of intervention (week 7)
measure: Signs and symptoms of nicotine withdrawal
timeFrame: Weeks 1-7 during intervention period
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
Study officials:
affiliation: Creighton University
name: Amy Mayer, OTD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burns TL, Mayer AE, Washington-Krauth SM, Walters RW, Arouni AJ. Design and Feasibility of a Hatha Yoga Intervention for Smoking Cessation. Journal of Smoking Cessation 2014; doi:10.1017/jsc.2014.21.
Clinical trial NCT02933632: Accelerated Rehabilitation in Hip Arthroplasty
Official title: Accelerated Rehabilitation Versus Conventional Rehabilitation in Total Hip Arthroplasty: A Randomized Double Blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Osteoarthritis
Physiotherapy
Rehabilitation
Clinical Trials
Accelerated rehabilitation
Hip Replacement Arthroplasty
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
First posted: 2016-10-14
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Accelerated rehabilitation protocol in Total Hip Arthroplasty (THA-AR).

Detailed description: The accelerated rehabilitation protocol in Total Hip Arthroplasty (THA-AR) was designed to improve the functionality and optimize early discharge of patients undergoing THA surgery. This study compared physical therapy protocol in Total Hip Arthroplasty (THA-PT) already deployed in Porto Alegre Clinical Hospital with THA-AR.

Eligibility criteria: Inclusion Criteria:

* Patients of the Public Health System of our Country that were admitted with hip osteoarthritis diagnose and submitted to a total hip arthroplasty surgery in the Hospital de Clínicas de Porto Alegre (HCPA).

Exclusion Criteria:

* Patients who refused to participate in this study;
* Patients lived in another city;
* Patients undergoing surgery for total hip arthroplasty due to hip fracture;
* Patients with cognitive disorders or diseases that adversely affect its cognitive function (Alzheimer's disease, senile dementia).

Primary outcomes:
measure: Merle D'Aubigné and Postel score
timeFrame: From the moment of hospitalization until the day of hospital discharge, assessed up to four days.
Secondary outcomes:
measure: Length of hospital stay
timeFrame: From the moment of hospitalization until the day of hospital discharge, assessed up to four days.
measure: Muscle strength force
timeFrame: From the moment of hospitalization until the day of hospital discharge, assessed up to four days.
measure: Goniometry
timeFrame: From the moment of hospitalization until the day of hospital discharge, assessed up to four days.
measure: Time to beginning the gait.
timeFrame: From the date of hospitalization until the day that began gait, assessed up to four days.
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Federal University Rio Grande do Sul
state: Rio Grande Do Sul
Study officials:
affiliation: Federal University Rio Grande do Sul
name: Carlos R Galia, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marchisio AE, Ribeiro TA, Umpierres CSA, GalvAo L, Rosito R, Macedo CAS, Galia CR. Accelerated rehabilitation versus conventional rehabilitation in total hip arthroplasty (ARTHA): a randomized double blinded clinical trial. Rev Col Bras Cir. 2020;47:e20202548. doi: 10.1590/0100-6991e-20202548. Epub 2020 Aug 12. English, Portuguese.
Clinical trial NCT04533932: Endosonographic Shear Wave Elastography for Liver Stiffness
Official title: Endosonographic Real-time and Shear Wave Elastography to Assess Liver stiffness-a Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Cirrhosis
Lead sponsor: Midwest Veterans' Biomedical Research Foundation
Sponsor class: OTHER
Collaborators: name: Olympus Corporation of the Americas
First posted: 2020-09-01
Enrollment: 40
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 undergoing liver biopsy

Brief summary: This is a single-center, prospective, non-randomized, comparative study which will compare the diagnostic accuracy and safety of endosonographic real-time Elastography and shear wave Elastography with the current standards of care, i.e. liver biopsy and Vibration-controlled transient elastography (Fibroscan). Subjects who are referred for an endoscopic ultrasound (EUS) guided liver biopsy will be prospectively enrolled to undergo liver biopsy, Elastography and/or Vibration-controlled transient elastography.


Eligibility criteria: Inclusion Criteria:

* Patients referred for EUS guided liver biopsy
* Elevated liver enzymes without obvious etiology, thus necessitating liver biopsy or clinical concern for cirrhosis or NASH requiring histological confirmation
* Ability to provide informed consent and willing to participate

Exclusion Criteria:

* Clinical evidence of cirrhosis which obviates need for liver biopsy
* Noninvasive lab testing which confirms presence of cirrhosis
* Surgically altered foregut anatomy which precludes safe endoscopic liver biopsy
* Coagulopathy with INR greater than 1.6 in patients on anticoagulant therapy
* Thrombocytopenia with platelet count less than 50,000/mL
* Pregnancy (positive urine pregnancy test in females of childbearing age)
* Lack of consent

Primary outcomes:
measure: Degree of fibrosis
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Kansas City VA Medical Center
state: Missouri
Study officials:
References:
citation: Kohli DR, Mettman D, Andraws N, Haer E, Porter J, Ulusurac O, Ullery S, Desai M, Siddiqui MS, Sharma P. Comparative accuracy of endosonographic shear wave elastography and transcutaneous liver stiffness measurement: a pilot study. Gastrointest Endosc. 2023 Jan;97(1):35-41.e1. doi: 10.1016/j.gie.2022.08.035. Epub 2022 Aug 29.
Clinical trial NCT03828032: Multi-parameters'Change Process During Dehydration Therapy on Brain Edema Patients.
Official title: Alternations of Multi-parameters Including Hemodynamic Concentration and Water Levels During Dehydration Therapy on Brain Edema Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemodynamic Instability
Water on the Brain
Intracranial Pressure Increase
Keywords: Brain edema
dehydration
Noninvasive optical method
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
Collaborators: name: Affiliated Hospital of Armed Police Logistics College
First posted: 2019-02-04
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to investigate the inner mechanism during different dehydration therapies such as mannitol injection and hypertonic saline. The investigators used a self-made near infrared spectroscopy (NIRS) instrument to monitor the physiological changes noninvasively including oxyhemoglobin (\[HbO2\]), deoxy-hemoglobin (\[Hb\]), the derived change in blood volume (\[tHb\]) and water concentration on the forehead of brain edema patients.

Detailed description: Cerebral edema, as an acute head injury along with high intracranial pressure, has been of great interest over decades in clinical neurosurgery research. Dehydration therapy is a common clinical method to decrease intracranial pressure. This study aims to investigate the inner mechanism during different dehydration therapies such as mannitol injection and hypertonic saline. The investigators used a self-made near infrared spectroscopy (NIRS) instrument to monitor the physiological changes noninvasively including oxyhemoglobin (\[HbO2\]), deoxy-hemoglobin (\[Hb\]), the derived change in blood volume (\[tHb\]) and water concentration on the forehead of brain edema patients. Then the investigators compared the changes process of multiple physiological parameters during different dehydration therapies.

Eligibility criteria: Inclusion Criteria:

• Patients who had brain edema and need dehydration therapy to decrease intracranial pressure.

Exclusion Criteria:

* AIDS, Active Hepatitis, Tuberculosis, Syphilis
* Patients who regularly take anticoagulants, antiplatelet drugs
* Anemia, thrombocytopenia
* Hemorrhagic disease like hemophilia

Primary outcomes:
measure: Δ[HbO2]
timeFrame: 2 weeks
measure: water concentration
timeFrame: 2 weeks
Secondary outcomes:
measure: intracranial pressure
timeFrame: 2 weeks
measure: Δ[Hb]
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02650232: Pilot Study to Evaluate the Somnotouch Device to Quantify Spontaneous Baroreflex Sensitivity
Official title: Pilot Study to Evaluate the Somnotouch Device to Quantify Spontaneous Baroreflex Sensitivity in Healthy Subjects and in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Heart Failure
Keywords: Volunteers
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: LivaNova
name: SomnoMedics
First posted: 2016-01-08
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To measure the spontaneous baroreflex sensitivity in ambulatory patient, a device made for measuring blood pressure beat by beat and continuously, the SOMNOtouch system, could be a useful tool. The SOMNOtouch system has never been used to assess the sensitivity of the baroreflex. A good correlation for measuring the baroreflex sensitivity between the system "SOMNOtouch" and digital photoplethysmography as a reference method is expected but should be evaluated. The main purpuse is to evaluate the SOMNOtouch system to quantify the spontaneous baroreflex sensitivity in healthy young subjects, in elderly healthy subjects and in subjects with heart failure. We will also evaluate the feasibility of measuring the baroreflex sensitivity in ambulatory conditions for 24 hours, the variations in sensitivity of the baroreflex sensitivity between day and night, the reproducibility of orthostatic tolerance test.


Eligibility criteria: For healthy volunteers

Inclusion Criteria:

* good health
* normal ECG
* cardiac ejection fraction \> 50%

Exclusion Criteria:

* with chronic disease or treatment
* under law protection
* not affiliated to the national health insurance

For patients with heart failure

Inclusion Criteria:

* clinically sable
* with sinusal heart rhythm
* without sign of neuropathy
* cardiac ejection fraction \< 50%

Exclusion Criteria:

* with pace maker
* under law protection
* not affiliated to the national health insurance
* skin lesion or severe allergia

Primary outcomes:
measure: Coefficient of correlation in baroreflex sensitivity measurements between SOMNOTOUCH and FINAPRES nova during the orthostatic test
timeFrame: Day one
Secondary outcomes:
measure: Coefficient of correlation in baroreflex sensitivity measurements between day one and day two during the orthostatic test
timeFrame: Day two vs Day one
measure: Duration of recordings in hours over 24 hours that allows the measurement of the spontaneous baroreflex sensitivity with the SOMNOTOUCH system
timeFrame: Day one (24 hours)
measure: Difference in the baroreflex sensitivity between Day & Night
timeFrame: Day one (24 hours)
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'Angers
state: Maine Et Loire
city: Cholet
country: France
facility: CH de Cholet
state: Maine Et Loire
Study officials:
References:
Clinical trial NCT06701032: Hemodynamic Parameters in People with Atherosclerotic Vascular Disease Referred to a Secondary Prevention and Cardiovascular Rehabilitation Program
Official title: Evolution of Hemodynamic Parameters in People with Atherosclerotic Vascular Disease Referred to a Secondary Prevention and Cardiovascular Rehabilitation (PREV) Program: a Prospective Cohort Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Artery Disease (PAD)
Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
Cerebrovascular Atherosclerosis
Keywords: cardiovascular rehabilitation
supervised exercise therapy
secondary prevention
cardiovascular secondary prevention
cardiovascular rehabilitation program
hemodynamics of lower limbs
toe pressure measurement
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: CISSS de Chaudière-Appalaches
First posted: 2024-11-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The main purpose of this study is to evaluate the hemodynamic changes in the forefoot of patients with coronary, cerebrovascular or peripheral atherosclerotic disease referred a 12-week cardiovascular rehabilitation program (PREV program).

Also, this study will describe the characteristics of patients admitted to the PREV program and their evolutions in terms of favorable, unfavorable outcomes and complications and up to one year after completion of the program.


Eligibility criteria: Inclusion Criteria:

* Any individual aged 18 years and older who has been diagnosed with peripheral artery disease, coronary artery disease, angina, ischemic heart failure, transient ischemic attack or ischemic stroke (non-cardioembolic, non-hemorrhagic);
* Have been admitted to the PREV program;

Exclusion Criteria:

* Being not able to give written informed consent;

Primary outcomes:
measure: Change in toe pressure measurement
timeFrame: Change from baseline to 12 weeks
measure: Change in the toe-brachial index
timeFrame: Change from baseline to 12 weeks
measure: Change in the ankle-brachial index
timeFrame: Change from baseline to 12 weeks
Secondary outcomes:
measure: Change in 6-minute walk test (6MWT)
timeFrame: Change from Baseline to 12 weeks
measure: Short Form Health Survey 36 (SF-36)
timeFrame: Change from baseline to 12 weeks
Other outcomes:
Locations:
city: Lévis
country: Canada
facility: CLSC de Lévis - Programme PREV du CISSS de Chaudière-Appalaches
state: Quebec
Study officials:
References:
Clinical trial NCT03920332: Pregnancy and Fibrinogen Disorders
Official title: Obstetric Outcomes of Women Suffering From Hereditary Fibrinogen Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypofibrinogenemia, Congenital
Afibrinogenemia, Congenital
Dysfibrinogenemia, Congenital
Keywords: Pregnancy
obstetric
miscarriage
haemorrhage
fibrinogen
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Swiss Hemophilia Network
First posted: 2019-04-18
Enrollment: 149
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women will be recruited in Hemophilia Centers.

Brief summary: The aim of this observational study is to evaluate the prevalence of uncomplicated pregnancies in women suffering from congenital fibrinogen disorders (i.e, hypofibrinogenemia, dysfibrinogenemia, hypodysfibrinogenemia) as well as to describe pregnancies outcomes in such diseases.

Detailed description: Women with quantitative or qualitative fibrinogen disorders are often more prone to obstetrical complications, from bleeding to recurrent miscarriages or thrombosis. Data on fibrinogen levels variations throughout the pregnancy and on the delivery management are lacking. In this observational study will be include adult women with pas obstetrical history. A general questionnaire on demographics and clinical data will be filled out by the patient's physician. A detailed questionnaire on obstetrical data will also be completed contacting the patient in case of lacking data.

Eligibility criteria: Inclusion Criteria:

* Inherited fibrinogen disorders (hypofibrinogenemia, dysfibrinogenemia, hypodysfibrinogenemia)
* At lest one past pregnancy
* Adult

Exclusion Criteria:

* No past pregnancy
* Not confirmed fibrinogen disorder

Primary outcomes:
measure: Prevalence of normal issue pregnancy
timeFrame: At inclusion
Secondary outcomes:
measure: Prevalence of pregnancy without complications
timeFrame: At inclusion
measure: Modalities of delivery
timeFrame: At inclusion
measure: Modalities of delivery
timeFrame: At inclusion
measure: Post-partum complications
timeFrame: At inclusion
measure: Fibrinogen variations
timeFrame: At inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Port-Royal
city: Martin
country: Slovakia
facility: Jessenius Faculty of Medicine and University Hospital
city: Geneva
country: Switzerland
facility: University Hospitals of Geneva
Study officials:
affiliation: University Hospitals of Geneva
name: Alessandro Casini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: APHP
name: Justine Hugon-Rodin, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00775632: Alemtuzumab and Cyclosporine for the Prevention of Graft vs Host Disease After Stem Cell Transplants
Official title: A Phase II Randomized Study Comparing Low Dose Alemtuzumab and Cyclosporine With Standard of Care for the Prevention of Chronic Extensive GVHD for Patients Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation (PBSCT) for Hematological Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Graft Versus Host Disease
Bone Marrow Transplantation
Keywords: Graft Versus Host Disease
Alemtuzumab
Campath
Bone Marrow Transplants
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2008-10-20
Enrollment: 78
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Graft versus host disease (GVHD) is one of the common complications after stem cell transplant. This is a complication, which happens when the new stem cells from the donor attack other cells in the body of the transplant recipient.

Recently, an antibody (protein) called alemtuzumab or Campath has been found to be effective in the prevention of Graft vs. Host Disease.

Previous studies have shown a low risk of GVHD with alemtuzumab, however the risk of disease recurrence was high. Previous studies have used a high dose of alemtuzumab. The purpose of this study is:

* To find if by lowering the dose of alemtuzumab, can serious GVHD be prevented without increasing the risk of relapse (your condition getting worse).
* To find whether low dose of alemtuzumab in combination with cyclosporine can prevent GVHD more effectively when compared to current standard of care and does not increase the risk of recurrence.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of a hematological malignancy
* Peripheral blood as source of stem cells
* Able to give informed consent
* Availability of 6/6 matched sibling donor
* Fit for transplant using a conventional or reduced intensity approach

Exclusion Criteria:

* AST/ALT \>3 x IULN at the time of transplant
* Serum creatinine \> 1.5 x IULN at the time of transplant
* Prior allogeneic transplant
* Syngeneic donor
* Active uncontrolled infection
* HIV positive
* Pregnancy at the time of BMT

Primary outcomes:
measure: Chronic extensive GVHD at 1-year (yes vs. no)
timeFrame: 12 months from the date of transplant
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: University Heath Network
name: Vikas Gupta, MD
role: PRINCIPAL_INVESTIGATOR
References: