louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01584167: A Randomized Trial Comparing 2 Methods for Rapid Induction of Cooling in Stroke Patients, Cold Infusions vs. EMCOOLS Flex.Pads (iCOOL 2)
Official title: iCOOL 2 (Induction of COOLing 2): A Randomized Trial Comparing 2 Methods for Rapid Induction of Cooling in Stroke Patients, Cold Infusions vs. EMCOOLS Flex.Pads
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ischemic Stroke
Hemorrhagic Stroke
Keywords: hypothermia
induction of hypothermia
cold infusion
whole-body cooling
external cooling
surface cooling
non invasive cooling
stroke
intracranial hemorrhage
cerebrovascular disease
neuro intensive care
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2012-04-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mild hypothermia improves outcome in patients with global cerebral ischemia after cardiac arrest. Hypothermia seems promising also in other acute hypoxic-ischemic or in brain swelling associated cerebrovascular disease. The narrow-time-frame is a major issue ("time is brain"). To provide immediate cooling without delay, easy to use, mobile and effective methods are needed. Cold infusions (4 °C) are an accepted standard worldwide. EMCOOLS Flex.Pads (Emergency Medical Cooling Systems AG, Wien, Austria) is a new non-invasive surface cooling system. A comparison of these two induction methods has never been done before. Neither was the effect of EMCOOLS Flex.Pads on brain-temperature measured. For the first time iCOOL 2 compares feasibility, safety and efficacy of the two methods.


Eligibility criteria: Inclusion Criteria:

* Sedation
* Combined ICP-temperature-probe
* Indication to lower body temperature \> 1.5°C
* Age ≥ 18 years

Exclusion Criteria:

* Body weight \> 120 kg
* Severe renal insufficiency
* Acute pulmonary embolism
* Acute myocardial infarction
* High-grade heart valve stenosis or insufficiency
* Severe cardiac insufficiency (NYHA ≥ III)
* Threatening ventricular dysrhythmia
* Cardiac dysrhythmia with bradycardia (heart rate \< 45 /min, QTc \> 450 ms, sick sinus syndrome, AV-block II-III°).
* Known hematologic disease with increased risk of thrombosis (e.g. cryoglobulinemia, cold agglutinins, sickle cell anemia)
* Known vasospastic vascular disorder (e.g. Raynaud's phenomenon or thromboangiitis obliterans)
* Skin lesions not allowing a secure application of the EMCOOLS Flex.Pads

Primary outcomes:
measure: Brain temperature
timeFrame: -15 to +60min
Secondary outcomes:
measure: (Neuro-)vital parameters
timeFrame: -15 to +180 min
measure: Cerebral autoregulation
timeFrame: 15 to +180 min
measure: Safety
timeFrame: 0 - 7 days
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Neuro Intensive Care Unit 2, Dept. of Neurology, University Hospital Heidelberg
Study officials:
affiliation: University Hospital Heidelberg
name: Sven Poli, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02405767: BioimPEDance of Diabetic Foot Ulcers
Official title: Characterisation by Electric Impedance Measurements of the Different Wound Healing Phases of Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcer
Keywords: Diabetic foot ulcer
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Commissariat A L'energie Atomique
First posted: 2015-04-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The BIPPED study seeks to determine whether wound healing, in particular diabetic foot ulcers, can be monitored using electrical bioimpedance analysis (BIA). BIA measures the resistance of biological tissue to the passage of a very small electric current applied with electrodes. Different types of tissue, due to cell structure, hydration and vascularization, have specific electrical characteristics. The BIPPED study aims to provide experimental data for the development of a BIA sensor for monitoring of wound healing in chronic wounds.


Eligibility criteria: Inclusion Criteria:

* diabetic patient (Type 1 or 2) with diabetic foot ulcer or lower limb ulcer
* written informed consent signed
* insured by the French national health insurance scheme

Exclusion Criteria:

* wound in the similar position on the other limb
* people under legal protection
* unilateral limb oedema
* contra-indication to impedancemetry : pregnancy, patient with a pacemaker, neurostimulator or any other implanted electrical device, metallic prostheses
* patients participating to other protocols involving foot ulcers measurement, if it interfers with the current protocol.

Primary outcomes:
measure: Change in impedance
timeFrame: 3 months
Secondary outcomes:
measure: Impedance of different wound tissues
timeFrame: 3 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Grenoble University Hospital
Study officials:
References:
citation: Lukaski HC, Moore M. Bioelectrical impedance assessment of wound healing. J Diabetes Sci Technol. 2012 Jan 1;6(1):209-12. doi: 10.1177/193229681200600126.
Clinical trial NCT05086367: Effects of Breathing Exercises on Pain, Range of Motion and Neck Disability in Patients With Cervical Spondylosis
Official title: Effects of Breathing Exercises on Pain, Range of Motion and Neck Disability in Patients With Cervical Spondylosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Spondylosis
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2021-10-20
Enrollment: 72
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: A randomized controlled trial was conducted on 72 diagnosed patients with cervical spondylosis at University of Lahore Teaching hospital. The study was completed within 9 months after the approval of synopsis. Patients who fulfill the inclusion criteria were identified by individual physiotherapist and were enrolled for particular study. Informed written consent was be taken by the patients and were randomly allocated into two groups. The total numbers of sessions were 12 (3 sessions per week). The study was single blinded. The assessor was unaware of the treatment given to both groups.

Control group received only routine physical therapy. This includes thermotherapy, trans-cutaneous electrical nerve stimulation, neck isometrics and stretching that includes 12 sessions and three times per week.

Experimental group received routine physical therapy along with breathing exercises. This includes thermotherapy, trans-cutaneous electrical nerve stimulation, neck isometrics and stretching that includes 12 sessions and three times per week.

Baseline data was collected before first treatment then after 4th, 8th and 12th session.

The outcome measures were neck pain, ROM, neck disability and quality of life and were analyzed by using SPSS 26 and then results and conclusion were drawn.


Eligibility criteria: Inclusion Criteria:

* Diagnosed patients with cervical spondylosis
* Both male and female
* Age from 40-60 years

Exclusion Criteria:

* Any deformity of spine
* Any surgery of spine
* Tumor
* Trauma \& Fracture
* Cervical radiculopathy
* Respiratory diseases

Primary outcomes:
measure: Change in Visual Analogue Scale score
timeFrame: Change from pre-intervention to 4 weeks
measure: Change in Universal Goniometer readings
timeFrame: Change from pre-intervention to 4 weeks
measure: Change in Neck Disability Index score
timeFrame: Change from pre-intervention to 4 weeks
Secondary outcomes:
measure: Change in SF-36 Questionnaire score
timeFrame: Change from pre-intervention to 4 weeks
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: University of Lahore Teaching Hospital
state: Punjab
Study officials:
References:
Clinical trial NCT00475267: Aortic Valve Replacement With Trifecta(TM)
Official title: An Observational, Prospective Evaluation of the Trifecta Valve
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Insufficiency
Regurgitation, Aortic Valve
Aortic Valve Incompetence
Aortic Valve Stenosis
Keywords: aortic valve
heart valve
tissue valve
bioprosthesis
valve disorder
valve disease
cardiac surgery
aortic valve stenosis
aortic valve regurgitation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2007-05-21
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to confirm the clinical safety and effectiveness of the Trifecta valve.

Detailed description: The clinical investigation is a multi-center, multi-country, prospective, non-randomized, observational study designed to evaluate the safety and effectiveness of the Trifecta valve.

Eligibility criteria: Inclusion Criteria:

* Requires aortic valve replacement (heart surgery such as bypass is allowed at the same time).
* Legal age.
* Signed informed consent prior to surgery.
* Willing to complete all follow-up requirements.

Exclusion Criteria:

* Pregnant or nursing women.
* Have already had a valve replaced other than the aortic valve.
* Needs another valve replaced.
* Cannot return for required follow-up visits.
* Have active endocarditis.
* Acute preoperative neurological event (such as a stroke).
* Renal dialysis.
* History of substance abuse within one year, or a prison inmate.
* Participating in another study.
* Life expectancy less than two years.

Primary outcomes:
measure: Characterize patient NYHA functional classification status.
timeFrame: At required follow-up intervals
measure: Characterize the hemodynamic performance of the valve.
timeFrame: At required follow-up intervals
measure: Establish adverse event rates.
timeFrame: Ongoing
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia, St. Paul's Hospital
state: British Columbia
city: Halifax
country: Canada
facility: QEII Health Sciences Center
state: Nova Scotia
city: Toronto
country: Canada
facility: University Health Network - Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Québec
country: Canada
facility: Hôpital Laval
state: Quebec
Study officials:
affiliation: Mayo Clinic
name: Hartzell Schaff, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04710667: To Explore the Effects of Different Training Periods and Dietary Pattern on the Gut Microbiota, Metabolites and Protein Expression Levels of Strength and Endurance Athletes and to Find Relevant Biological Indicators.
Official title: Sports Science Institute
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Athlete
Lead sponsor: National Taiwan Sport University
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recruitment of 12 healthy muscle and endurance athletes from the National Sports University

Brief summary: The gastrointestinal tract contains hundreds of millions of microorganisms, collectively called the intestinal flora, which plays an important role in the health of the host. Many studies have also confirmed that the composition and function of the intestinal flora can be changed through the training chain. Changes in the composition of intestinal microbes can affect exercise performance, energy metabolism, oxidative stress, immune function, inflammation, and tissue repair. Therefore, maintaining a healthy gut microbial balance is essential for athletes' health, training, nutritional status, and athletic performance. This project intends to use metagenomics, proteomics, and metabolomics and other technologies to systematically explore the effects of different training periods and dietary interventions on the intestinal flora of muscle strength and endurance athletes. , Protein expression and the influence of metabolites. In the plan, explore the differences in the intestinal flora between muscle strength and endurance sports athletes during the preparation period, competition period, and transition period, and collect blood and feces to perform protein and metabolite molecular changes. It is hoped that through the smooth implementation of this research project, the research results can be applied to personalized diet planning, improve intestinal adaptability and the effectiveness of sports nutrition intervention, and then adjust athletes' status and improve sports performance to win the highest honor for the country in the arena.


Eligibility criteria: Inclusion Criteria:

* 20-30 years old healthy muscle strength and endurance sports athletes

Exclusion Criteria:

1. Exclude cardiovascular disease, hypertension, metabolic disease, asthma, or neuromuscular sports injuries within six months, etc.
2. Exclude those who regularly take lactic acid bacteria-related foods for a long time
3. Exclude students and related stakeholders under the guidance of the project host

Primary outcomes:
measure: Differences in intestinal flora of athletes in sports during preparation, competition and transition periods
timeFrame: 2021/1/1-2021/2/28
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: National Taiwan Sport University
Study officials:
References:
Clinical trial NCT00701467: Change in Heart Rate Variability Prior to Tachyarrhythmia in ICD Implanted Patients
Official title: HRV Registry to Investigate Changes During the Time Before a Spontaneous Episode of Ventricular Tachyarrhythmia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Tachyarrhythmia
Keywords: ICD
ICD implanted patients
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-06-19
Enrollment: 50
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: ICD clinic

Brief summary: To investigate changes in HRV during the time before a spontaneous episode of ventricular tachyarrhythmia.


Eligibility criteria: Inclusion Criteria:

* S/P lexos VR/-T,DR/-T implantation
* Signed patient informed consent

Exclusion Criteria:

* CAF
* Life expectancy\<6 months
* Impending heart transplant
* Persistent recurring tachycardia
* Rhythm disturbances that preclude a meaningful HRV analysis
* Participation in another study.

Primary outcomes:
measure: Change in RR interval recorded by ICD
timeFrame: within an hour before ventricular tachyarrythmia
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Arrythmia Service Center
Study officials:
affiliation: SHEBA MC
name: Michael Glikson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06113367: Immunotherapy in Upper Tract Urothelial Carcinoma
Official title: Carcinomes urothéliaux Des Voies excrétrices supérieures traitées en Vie réelle Par immunothérapie (VESUVIO) : étude rétrospective Nationale
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Urothelial Carcinoma
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced/metastatic UTUC treated with second-line anti-PD-(L)1 immunotherapy

Brief summary: Upper-tract urothelial carcinoma (UTUC) is a rare tumor. Standard treatment of localized disease is most often radical nephroureterectomy.

In advanced/metastatic disease, treatments follow the standards for urothelial carcinoma including platinum-based chemotherapy and anti-PD(L)1 (Programmed death (ligand) 1) immunotherapy, with no regard as to the primary disease site (bladder or upper tract). Given the rarity of UTUC, efficacy data in the UTUC subgroup of advanced urothelial carcinoma is scarce.

UTUC show distinct pahological and molecular features, including higher prevalence of microsatellite instability and of abnormalities in the FGFR (fibroblast growth factor receptors) gene family. These specific features may impact outcomes of immunotherapy in advanced/metastatic UTUC.


Eligibility criteria: Inclusion Criteria:

* Age 18 and more
* Diagnosis of urothelial carcinoma (with or without variant histology)
* Advanced/metastatic disease not amenable to local treatment with curative intent
* Treatment with an anti-PD-(L)1 monoclonal antibody initiated between 2016 and 2022

Exclusion Criteria:

* Patient's opposition to this research
* Urothelial carcinoma of bladder or urethral primary site
* Non-urothelial tumor
* Maintenance immunotherapy initiated without disease progression

Primary outcomes:
measure: Overall survival on anti-PD-(L)1 immunotherapy
timeFrame: 2 years after immunotherapy initiation
Secondary outcomes:
measure: Best Objective Radiologic Response
timeFrame: Up to 7 years maximum
measure: Overall survival
timeFrame: 5 years after immunotherapy initiation
measure: Progression free survival
timeFrame: 6 months after immunotherapy initiation
measure: Progression free survival
timeFrame: 1 year after immunotherapy initiation
measure: Progression free survival
timeFrame: 2 years after immunotherapy initiation
measure: Progression free survival
timeFrame: 3 years after immunotherapy initiation
measure: Duration of immunotherapy treatment
timeFrame: Up to 7 years after immunotherapy initiation
measure: Reasons for treatment discontinuation
timeFrame: Up to 7 years after immunotherapy initiation
measure: Translational study of predictive biomarkers of efficacy
timeFrame: Up to 7 years after immunotherapy initiation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02830867: Review of French Cases of Glutathione Synthetase Deficiency
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: The Glutathione Synthetase Deficiency
Keywords: glutathione
glutathione synthetase deficiency
autosomal inheritance
recessive
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2016-07-13
Enrollment: 100
Sex: ALL
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: All patients followed in the French hospital centers the diagnosis of glutathione synthetase deficiency has been proven by assay of residual enzyme activity or identifying a mutation of the glutathione synthetase gene

Brief summary: The glutathione synthetase deficiency, inborn error of metabolism of autosomal recessive inheritance, is a rare disease (70 patients described in the world). The outcome of these patients and potential complications of this disease are not, to date, yet all known and described.


Eligibility criteria: Inclusion criteria:

* All patients followed in the French hospital centers the diagnosis of glutathione synthetase deficiency has been proven by assay of residual enzyme activity or identifying a mutation of the glutathione synthetase gene

Exclusion criteria:

* No formal proof of glutathione synthetase deficiency

Primary outcomes:
measure: Immunologically determining human acid glutathione S-transferase in a human assay sample
timeFrame: 1 hour after hospitalization
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service D'Urgences Medicales Pediatriques
Study officials:
References:
Clinical trial NCT02700867: Trial Comparing Proximal Tibia and Proximal Humerus Infusion Rates Using the NIO Intraosseous Device
Official title: A Randomized Crossover Cadaver Trial Comparing Proximal Tibia and Proximal Humerus Infusion Rates Using the NIO Intraosseous Device During Simulated Cardiopulmonary Resuscitation Performed by Paramedics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraosseous Access
Resuscitation
Keywords: intraosseous access
cardiopulmonary resuscitation
paramedic
simulation
cadaver
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2016-03-07
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators sought to compare the intraosseous access success rates of the proximal tibia and the proximal humerus using new Intraosseous access device "NIO" in an adult cadaver model during simulated resuscitation.


Eligibility criteria: Inclusion Criteria:

* give voluntary consent to participate in the study
* paramedics
* without previous experience in intraosseous devices

Exclusion Criteria:

* not meet the above criteria

Primary outcomes:
measure: Success rate
timeFrame: 1 day
Secondary outcomes:
measure: Time of IO insertion
timeFrame: 1 day
measure: Ease-of-use
timeFrame: 1 day
measure: first location
timeFrame: 1 day
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical University of Warsaw, Department of Emergency Medicine
state: Masovia
Study officials:
References:
citation: Szarpak L, Truszewski Z, Smereka J, Krajewski P, Fudalej M, Adamczyk P, Czyzewski L. A Randomized Cadaver Study Comparing First-Attempt Success Between Tibial and Humeral Intraosseous Insertions Using NIO Device by Paramedics: A Preliminary Investigation. Medicine (Baltimore). 2016 May;95(20):e3724. doi: 10.1097/MD.0000000000003724.