louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03512912: Transcutaneous Electrostimulation for Intermittent Claudication Supervised Walking Therapy for Intermittent cLAudication
Official title: Transcutaneous Electrostimulation of the Calf Muscle and Supervised Walking Therapy for Intermittent cLAudication
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intermittent Claudication
Peripheral Arterial Disease
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2018-05-01
Enrollment: 20
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: All patients of our department of vascular end endovascular surgery, university hospital Dusseldorf with the above mentioned inclusion criteria.

Brief summary: Prospective mono-centric trial on patients with peripheral arterial disease and intermittent claudication that receive supervised exercise therapy (group 1) vs. supervised exercise therapy + daily transcutaneous electro-stimulation of the calf muscles.

Detailed description: The investigators conduct a prospective mono-centric trial on all patient with peripheral arterial disease with intermittent claudication that receive supervised exercise therapy (SET) and additional transcutaneous electric stimulation (TES) of the calf muscle. SET program consists in once weekly walking training for 75 min under supervision of a professional trainer. Patients are encouraged to continue the training modules at home. TES is performed using the mobile "Veinoplus arterial" device (AdRem Technology, France) on a daily base for 60-120 min at home. Patient outcome will be compared to the retrospectively analyzed results of patients, that received the same SET program alone in the past.

Eligibility criteria: Inclusion Criteria:

* intermittent claudication due to peripheral arterial disease
* ankle brachial index \</=0.9
* occlusion or stenosis of the superficial femoral artery

Exclusion Criteria:

* rest pain or peripheral arterial lesions
* contraindications for supervised walking therapy
* non-vascular conditions that limit patients´ walking ability
* patients that have already received supervised walking therapy
* occlusion of the deep femoral artery
* occlusion or high-grade stenoses of the iliac arteries
* stroke in the last 12 months
* premenopausal women
* diabetes mellitus, dialysis, sclerodermia and other conditions that impair leg perfusion
* active cilostazol therapy or alprostadil-infusion in the last 3 months
* pacemaker, defibrillator systems, life vest
* visible muscle contraction is not achieved without pain

Primary outcomes:
measure: Walking distance
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dusseldorf
country: Germany
facility: University Hospital Dusseldorf, Department of Vascular and Endovascular Surgery
state: NRW
Study officials:
affiliation: Department of Vascular and Endovascular Surgery
name: Philip Düppers, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01832012: Basic Life Support Cardiopulmonary Resuscitation Refresher in MS2 at St George's University
Official title: Practical Skill Retention in Medical Students: Improving Cardiopulmonary Resuscitation With Hands-On Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiopulmonary Resuscitation Skill Retention in Medical Students
Keywords: Eliciting which type of refresher provides the greatest improvement in BLS CPR skills.
Lead sponsor: Windward Islands Research and Education Foundation
Sponsor class: OTHER
First posted: 2013-04-15
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 175 second year medical students were assessed on their BLS CPR skill retention after an approximate one year after taking the initial certification class, and the investigators assessed which type of refresher course would be most effective in improving the students' CPR skills. Group 2 had no refresher, Group 3 had a multimedia refresher, and Group 4 had the same multimedia refresher plus hands on practice on a Laerdal BLS manikin. The investigators hypothesized that Group 4 would perform CPR skills with the highest competency compared to the other two groups.


Eligibility criteria: Inclusion Criteria:

* Voluntary second year medical student

Primary outcomes:
measure: Chest compressions
timeFrame: 1 session
measure: Bag Valve Mask ventilations
timeFrame: 1 session
Secondary outcomes:
Other outcomes:
Locations:
city: True Blue
country: Grenada
facility: St. George's University
state: St. George's
Study officials:
affiliation: St. George's University
name: Alexander M Dabrowiecki, BS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00623012: Rapamycin for Prevention of Chronic Graft-Versus-Host Disease
Official title: Rapamycin for Prevention of Chronic Graft-Versus-Host Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Graft Versus Host Disease
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2008-02-25
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate feasibility, toxicity and efficacy of using Rapamycin to prevent chronic graft-versus-host-disease (GVHD) during and after the tacrolimus taper in recipients of allogeneic stem cell transplant.

Our hypothesis is that the T cells that can cause chronic GVHD are suppressed but not eliminated by calcineurin inhibitors. Therefore, when the calcineurin inhibitors are discontinued, the T cells may get activated and result in GVHD. Rapamycin on the other hand will allow anergy formation and thus when discontinued, T cells should not get activated. The schedule is designed to have therapeutic rapamycin levels as the tacrolimus is discontinued. Rapamycin will be continued as a single agent for additional 4 weeks and be tapered off in two weeks.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Received an allogeneic MSD or MUD PBSCT
* 24 weeks post SCT
* Currently on Tacrolimus for GVHD prophylaxis
* Deemed eligible for tapering off of Tacrolimus by primary BMT physician

Exclusion Criteria:

* Relapsed Disease
* Ongoing GVHD
* Patients whose immunosuppression is being stopped early to treat or prevent relapse
* Patients with pure red cell aplasia due to ABO mismatched donor
* Ongoing thrombotic microangiopathy
* Allergy to rapamycin
* Women of childbearing potential must have a negative serum pregnancy test performed prior to the start of treatment

Primary outcomes:
measure: Improvement of the Rate of Graft Versus Host Disease (GVHD) From the Accepted Rate of 74%.
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Overall Survival
timeFrame: up to 10 weeks
measure: Disease Free Survival
timeFrame: up to 10 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Stuart Seropian, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004410: Randomized Study of Tauroursodeoxycholic Acid in Prophylactic Therapy of Total Parenteral Nutrition Associated Cholestasis in Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholestasis
Keywords: cholestasis
gastrointestinal disorders
rare disease
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 1999-10-19
Enrollment: 50
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Determine whether infants treated with tauroursodeoxycholic acid (TUDCA) have a lower peak direct bilirubin, ALT, AST, glutamyltranspeptidase levels and a reduced duration of cholestasis compared to the nontreatment arm.

II. Determine the significance of lower birth weight and longer duration of total parenteral nutrition (TPN) on increasing risk of TPN associated cholestasis and increasing benefit from TUDCA therapy.

III. Determine whether TUDCA therapy leads to significant reduction in the appearance of biliary tract sludge and/or stone formation in these infants.

IV. Determine whether TUDCA therapy leads to reduced urinary excretion of potentially hepatotoxic bile acids as compared to the untreated arm matched for birth weight and duration of TPN.

Detailed description: PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by birth weight.

Patients are randomized in pairs by birth weight to receive either a placebo in arm I or tauroursodeoxycholic acid (TUDCA) in arm II. TUDCA is administered by mouth, nasogastric tube, or gastrostomy tube twice daily. After 2 weeks of therapy, a bile sample is obtained via a duodenal tube. An ultrasound examination of the liver and biliary tract is performed after 2 weeks and every 3 weeks thereafter until discontinuation of therapy or until presence of biliary tract sludge is noted on 2 consecutive examinations.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Hospitalized infants who are anticipated to require total parenteral nutrition for greater than 2 weeks and have: Major gastrointestinal anomalies (gastroschisis, ruptured omphalocele) OR Resection (necrotizing enterocolitis, volvulus)
* No evidence of biliary tract abnormalities
* No evidence of other forms of cholestatic liver disease

--Patient Characteristics--

* Renal: No life threatening renal disease
* Cardiovascular: No life threatening cardiovascular disease
* Other: No multiple congenital abnormalities

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Children's Hospitals and Clinics - Minneapolis
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Cincinnati
country: United States
facility: Children's Hospital Medical Center - Cincinnati
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: James Heubi
role: STUDY_CHAIR
References:
Clinical trial NCT05171010: Geri-TBI: A Prospective Multi-center Evaluation of Geriatric Patients With Traumatic Brain Injury
Official title: Geri-TBI: A Prospective Multi-center Evaluation of Geriatric Patients With Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2021-12-28
Enrollment: 69
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Geriatric patients with TBI

Brief summary: This multicenter prospective observational study is designed to prospectively record data on patients who are managed per institutional standard of care. The objectives of this study are to establish an aggregate database of information on baseline clinical and demographic characteristics, medication use, markers of frailty, injury characteristics, management strategies, and outcomes following TBI in geriatric patients, determine best practices for management of geriatric patients with TBI, and establish how markers of frailty correlate with outcome in geriatric patients with TBI.

Detailed description: This is a prospective multi-center observational study of geriatric patients with TBI. Data collected will be purely observational and involve no study-based therapeutic interventions or alterations in patient care. Due to the purpose of this study being the creation of a registry and the absence of demographic information being collected, all patients meeting the inclusion criteria will be enrolled without informed consent. We plan to complete the data collection and analysis by 12/31/2018.

Eligibility criteria: Inclusion Criteria:

* Age ≥40
* CT-verified TBI

Exclusion Criteria:

1. Any other body region injury AIS \>2
2. Presentation at enrolling center \>24 hours after injury
3. Pregnant women
4. Prisoners

Primary outcomes:
measure: CT scan
timeFrame: "through study completion, an average of 1 year".
Secondary outcomes:
measure: Comorbidities
timeFrame: "through study completion, an average of 1 year".
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Michael Truitt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00779610: The Effects of Passive and Active Vibration Therapy on Grip Strength and Myoelectric Activity
Official title: The Effects of Passive and Active Vibration Therapy on Grip Strength and Myoelectric Activity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Strength
Lead sponsor: Logan College of Chiropractic
Sponsor class: OTHER
First posted: 2008-10-24
Enrollment: 40
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: TREATMENT

Brief summary: This pilot study is designed to analyze the effects of Vibration Therapy (VT) on grip strength and level of forearm contraction by measuring hand grip dynamometry and surface Electromyography (sEMG) using the BioPac sEMG and digital dynamometry devices after the application of both passive and active Vibrational Therapy (VT) using the PowerPlate.


Eligibility criteria: Inclusion Criteria:

* participants will be Logan students, faculty and staff 18-65 yoa
* asymptomatic subject will be included in the study
* participants must complete a survey and consent form
* only participants that meet the criteria of the survey will be accepted in the study

Exclusion Criteria:

* participant with any recent or past disease/injuries/trauma/fracture (i.e., arthritis, carpal tunnel, etc.)
* who have had joint replacements
* who are currently engaging in physical rehabilitation
* who are pregnant will be excluded from the study
* history of cardiovascular disease
* history of cancer
* history of epilepsy
* history of diabetes mellitus, or past retinal surgeries
* participants cannot have Chiropractic manipulation or engage in weight lifting or other extreme exercise throughout the duration of the study

Primary outcomes:
measure: Surface EMG and Grip Strength Dynamometry
timeFrame: Pre and Post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Chesterfield
country: United States
facility: Logan College of Chiropractic
state: Missouri
Study officials:
References:
Clinical trial NCT02948010: CPAP Device In-lab Assessment NZ
Official title: CPAP Device In-lab Assessment NZ
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2016-10-28
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to assess device performance against participants in an overnight study to ensure the product meets user and clinical requirements

Detailed description: Existing Adult Continuous Positive Airway Pressure (CPAP) therapy users will be recruited for an overnight polysomnography (PSG) sleep study. The participants will use the investigational CPAP device and be connected to a PSG during their session. The device performance during the session will be assessed. Outcomes of the clinical investigation include downloadable device data reports, device error reports and participants perception questionnaires and PSG data.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Diagnosed with OSA by a practicing physician and prescribed PAP therapy (fixed or auto CPAP)
* Fluent in spoken and written English.

Exclusion Criteria:

* Be contraindicated for PAP (fixed or auto CPAP) therapy.
* Have another significant sleep disorder(s) (e.g. periodic leg movements or insomnia).
* Have obesity hypoventilation syndrome or congestive heart failure.
* Require supplemental oxygen with your PAP (fixed or auto CPAP) device.
* Have any implanted electronic medical devices (e.g. cardiac pacemakers).
* Be pregnant or think they might be pregnant.

Primary outcomes:
measure: Apnea Hypopnea Index (AHI) (i.e. number of events/hour).
timeFrame: 4 months
measure: Log of safety-related events, measured as number of safety-related faults
timeFrame: 4 months
measure: Machine reported faults, measured as number of machine faults
timeFrame: 4 months
Secondary outcomes:
measure: Participant perception of the device, as determined by the questionnaire responses
timeFrame: 4 months
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Fisher & Paykel Healthcare
Study officials:
References:
Clinical trial NCT06877910: Deciphering the Molecular Traits of Non-canonical Responders to Advance Personalized Therapy in Gastric Cancer
Official title: Deciphering the Molecular Traits of Non-canonical Responders to Advance Personalized Therapy in Gastric Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Metastatic Gastric Cancer
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with locally advanced or metastatic inoperable GC who are candidates for first-line chemotherapy and who meet the following criteria.

Brief summary: Retrospective-prospective observational study in which a novel whole-exome sequencing (WES) approach will be used in association with whole-transcriptome sequencing (WTS) to analyze two independent and equally sized cohorts of patients with mGC.

Detailed description: A workflow specifically designed for this project will be adopted, using clinical outcomes as a benchmark for comparative analyses, to generate a molecular classifier applicable to all patients affected by metastatic gastric cancer mGC and predict atypical tumor responses. Molecular features differently represented in exceptional responders and fast progressors will be monitored by liquid biopsy in patients included in cohort B, consisting of a validation set, leveraging a high-sensitivity technological level that allows to detect both genomic alterations and expression at the transcription level.

In addition, CSCs isolated from fast progressors will be studied with over 1,000 antitumor agents to discover vulnerabilities not currently known.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years;
* Histological diagnosis of locally advanced or metastatic gastric cancer (GC) or gastroesophageal junction carcinoma (EJC);
* Adequate biological material for molecular analysis, collected (at surgery or by biopsy) before the administration of any anti-tumor treatment (chemotherapy and/or radiotherapy);
* ECOG PS 0-2;
* Adequate hematological, hepatic and renal function;
* Measurable disease according to RECIST criteria;
* Written informed consent.

Exclusion Criteria:

* Previous chemotherapy for metastatic disease;
* Comorbidities not controlled with adequate medical therapy;
* Brain metastases;
* Patient unable to give adequate consent to the study.

Primary outcomes:
measure: Progression-free survival PFS
timeFrame: 5 years
Secondary outcomes:
measure: Overall survival OS
timeFrame: 5 years
Other outcomes:
Locations:
city: Rome
country: Italy
facility: IRCCS National Cancer institute
Study officials:
References:
Clinical trial NCT01791010: Effects of Inspiratory Muscle Training in Elders
Official title: Respiratory Muscle Training in the Elderly: a Strategy for Preservation of Inspiratory and Expiratory Pressures Impacting on Mobility and Thickness of the Diaphragm.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscular Atrophy
Sensitivity Training Groups
Aging
Keywords: Breathing exercises
Aged
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2013-02-13
Enrollment: 22
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aging causes anatomical and physiological changes in the respiratory system and respiratory muscle strength with decline in its maximum function. This study aimed to evaluate the effects of inspiratory muscle training on respiratory muscle strength, thickness of the diaphragm and diaphragmatic mobility in older women. The investigators' hypothesis is that inspiratory muscle training improves respiratory muscle strength, the thickness of the diaphragm and diaphragmatic mobility in older women.


Eligibility criteria: Inclusion Criteria:

Elderly women are able to walk without aid and cognitive integrity.

Exclusion Criteria:

* Participation in other training or rehabilitation protocol;
* Contraindication or difficult to perform the evaluation;
* Difficulty adapting or adherence in training protocol;
* Smoking;
* Hemodynamic instability;
* Degenerative neuromuscular disease;
* Pulmonary comorbidities;
* Heart disease;
* Users of drugs that interfere in bone metabolism or muscle strength.

Primary outcomes:
measure: respiratory muscle strength
timeFrame: Change from Baseline Respiratory Muscle Strength at 2 months
Secondary outcomes:
measure: Diafragmatic excursion and thickness of the diaphragm in the zone of apposition by ultrasonography
timeFrame: Change from Baseline Diafragmatic Excursion and Thickness of the Diaphragm at 2 months
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Federal University of Pernambuco
state: Pernambuco
Study officials:
References:
citation: Testa A, Soldati G, Giannuzzi R, Berardi S, Portale G, Gentiloni Silveri N. Ultrasound M-mode assessment of diaphragmatic kinetics by anterior transverse scanning in healthy subjects. Ultrasound Med Biol. 2011 Jan;37(1):44-52. doi: 10.1016/j.ultrasmedbio.2010.10.004.
citation: Ueki J, De Bruin PF, Pride NB. In vivo assessment of diaphragm contraction by ultrasound in normal subjects. Thorax. 1995 Nov;50(11):1157-61. doi: 10.1136/thx.50.11.1157.
citation: Enright SJ, Unnithan VB, Heward C, Withnall L, Davies DH. Effect of high-intensity inspiratory muscle training on lung volumes, diaphragm thickness, and exercise capacity in subjects who are healthy. Phys Ther. 2006 Mar;86(3):345-54.