louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02600572: Changes in Attention Level Due to Isometric Exercises and Level Three Progression Eccentric Movements
Official title: Changes in Attention Level Due to Isometric Exercises and Level Three Progression Eccentric Movements
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Therapy, Exercise
Keywords: balance, postural
postural equilibrium
mental speed
isometric exercise
eccentric exercise
Lead sponsor: Carrick Institute for Graduate Studies
Sponsor class: OTHER
First posted: 2015-11-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Determine the changes in attention level due to isometric exercises and level three progression eccentric movements. The attention level will be measured using a mental speed test (how quickly a subject can process information and make decisions based upon that information). Another outcome measure will be the ability of the subject to maintain balance

Detailed description: On Day 1, subjects will complete the mental speed test and will undergo CDP testing using the modified Clinical Testing of Sensory Integration in Balance (mCTSIB) protocol: the subjects will be required to stand on a hard or compliant surface (a 4" tall foam cushion of known mechanical properties) in a comfortable posture, feet shoulder width, with eyes open or closed, head straight and arms to the side and free to move, gazing forward, and breathing normally. These will constitute the baseline information. Subjects will be divided into two groups: a isometric group (performing the isometric exercises) and an eccentric group (performing the eccentric exercises). At the end of Day 1, the isometric group will perform the isometric exercises while the eccentric group will act as control (no exercise). On Day 2, subjects will complete the mental speed test and will undergo the CDP testing a second time. These will constitute the first follow-up information. At the end of Day 2, the eccentric group will perform the eccentric exercises while the isometric group will act as control (no exercise). Throughout Day 3, subjects will complete the mental speed test and undergo the CDP testing a third time. This will constitute the second and last follow-up information.

Eligibility criteria: Inclusion Criteria:

* Healthy individuals

Exclusion Criteria:

* Any pathology preventing the subject to safely perform the isometric exercises (the clinician enrolling the subjects will make the decision)

Primary outcomes:
measure: Changes in Stability Score
timeFrame: Baseline, Day 2 and Day 3
Secondary outcomes:
measure: Changes in Mental Speed
timeFrame: Baseline, Day 2 and Day 3
Other outcomes:
Locations:
city: Cape Canaveral
country: United States
facility: Carrick Institute for Graduate Studies
state: Florida
Study officials:
affiliation: Carrick Institute for Graduate Studies
name: Frederick R Carrick, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06479772: Evaluation of the Potential Impact of an Artificial Intelligence Solution in Second Reading of Organized Screening.
Official title: Evaluation of the Potential Impact of an Artificial Intelligence Solution in Second Reading of Organized Screening.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer Female
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
Collaborators: name: Vivactis M2Research
First posted: 2024-06-28
Enrollment: 55589
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: As this was a retrospective exploratory study, with no prior hypothesis, the number of subjects required was not calculated.

The study population (n=55,000) represents, for the radiology practices concerned, all mammograms examined in second reading by the Auvergne Rhône Alpes regional cancer screening coordination center between 2015 and 2019.

Brief summary: Based on data from a series of patients who underwent screening mammography with a "normal" or "benign" first-reading result. The main objective of the study is to evaluate the possibilities of subtracting from the second reading of breast cancer screening a population of examinations for which the risk of discovering cancer is close to zero, using an AI system (here the MammoScreen™ system).

Detailed description: This is a retrospective multicenter study of mammography imaging data contained in the PACS (Picture Archiving and Communication System) of six radiology centers located in the Rhône, Puy de dôme, Cantal and Haute-Loire départements.

In order to be able to collect two-year follow-up data, the files analyzed will concern all women who received a screening mammogram during the years 2015, 2016, 2017, 2018 and 2019. More recent mammograms will be excluded.

Eligibility criteria: Inclusion Criteria:

* Women aged 50 to 74 participating in the organized screening campaign.
* Having had a screening mammogram with a final L1 result of "normal" (ACR 1/ BI-RADS 1) or "benign" (ACR 2/ BI-RADS 2).
* For which a second reading interpretation is available
* Screening mammograms performed during the years 2015 to2019 (In order to have follow-up data (subsequent mammogram or information on the person's future)

Exclusion Criteria:

- Mammography not performed as part of organized screening

Primary outcomes:
measure: Percentage of real negatives
timeFrame: Week 8
Secondary outcomes:
measure: Percentage of real positives
timeFrame: Week 8
measure: Percentage of false negatives
timeFrame: Week 8
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Privé Jean Mermoz
Study officials:
affiliation: Hôpital Privé Jean Mermoz
name: Christophe TOURASSE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05702372: Acute Glycemic Effects of Crackers Made by Different Flours
Official title: Short-term Effects of Crackers on Glycemic Index and Glycemic Responses. A Randomized Trial in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Potential Abnormality of Glucose Tolerance
Appetitive Behavior
Keywords: blood glucose
crackers
glycemic index
glycemic load
Lead sponsor: Agricultural University of Athens
Sponsor class: OTHER
Collaborators: name: Institute of Technology and Agricultural Products
First posted: 2023-01-27
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover assignment
Primary purpose: OTHER

Brief summary: This study investigated the acute effects of cracker consumption made by different flours on glycemic responses.

Detailed description: This study aimed to determine the glycemic index and glycemic load of crackers made by different flours (wheat, whole wheat, and 30% sunflower seed flour substitution) and to investigate the effects of these types of crackers on postprandial glycemic responses in healthy humans. Moreover, blood pressure levels and subjective appetite were evaluated.

Eligibility criteria: Inclusion Criteria:

* healthy
* non-smoking
* non-diabetic men and women
* body mass index between 18 and 25 kg/m2

Exclusion Criteria:

* severe chronic diseases (e.g. cardiovascular diseases, diabetes mellitus, kidney or liver conditions, endocrine conditions)
* gastrointestinal disorders
* pregnancy
* lactation
* competitive sports
* alcohol abuse
* drug dependency

Primary outcomes:
measure: Glycemic index
timeFrame: 2 hours
measure: Capillary blood glucose responses
timeFrame: 2 hours
Secondary outcomes:
measure: Subjective appetite ratings
timeFrame: 2 hours
measure: Blood pressure
timeFrame: 2 hours
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Agricultural University of Athens
Study officials:
affiliation: Agricultural University of Athens
name: Emilia Papakonstantinou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02978872: Quantra Determination of Coagulation Parameters in Arterial and Venous Blood
Official title: Comparison of Coagulation Parameters in Arterial and Venous Blood Measured Using the Quantra System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgery
Keywords: Cardiac surgery
Quantra
Viscoelastic testing
Coagulation
Lead sponsor: HemoSonics LLC
Sponsor class: INDUSTRY
Collaborators: name: University of Virginia
First posted: 2016-12-01
Enrollment: 30
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: Adult patients scheduled for cardiac surgery, utilizing cardiopulmonary bypass, or including placement of a ventricular assist device.

Brief summary: The Quantra™ System is a novel point-of-care diagnostic device designed to perform whole blood coagulation analysis. This study compares Quantra measurements determined in arterial versus venous blood samples obtained from patients undergoing cardiac surgery.

Detailed description: The Quantra System is a fully integrated and automated in vitro diagnostic device which utilizes SEER Sonorheometry, an ultrasound-based technology, to characterize the dynamic changes in the viscoelastic properties of a blood sample during coagulation and clot lysis. Viscoelastic testing performed using existing technologies is typically performed on arterial samples obtained from patients undergoing surgical procedures, although reference ranges for these tests have been established for venous blood only.

The aim of this study is to evaluate potential differences between Quantra measurements determined in arterial versus venous blood samples obtained from patients undergoing cardiac surgery.

Eligibility criteria: Inclusion Criteria:

* Subject is scheduled for cardiac surgery, utilizing cardiopulmonary bypass, or including placement of a ventricular assist device
* Subject is ≥18 years
* Subject is willing to participate and he/she has signed a consent form
* Subject may participate if they have a history of bleeding or are on preoperative anticoagulant therapy

Exclusion Criteria:

* Subject is unable to provide written informed consent
* Subject is younger than 18 years
* Subject is incarcerated at the time of the study
* Subject is currently enrolled in a study that may confound the results of the proposed study
* Subject is affected by a condition that, in the opinion of the surgical team, may pose additional risks

Primary outcomes:
measure: Comparison of Clot Time and Clot Stiffness results between arterial and venous samples
timeFrame: Up to 24 hours
Secondary outcomes:
measure: Comparison of Quantra results to standard coagulation test results in venous samples
timeFrame: Up to 24 hours
measure: Comparison of Quantra results to comparable ROTEM results in venous samples
timeFrame: Up to 24 hours
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References:
Clinical trial NCT05112172: Effect of Oxygen Therapy for Patients With Precapillary Pulmonary Hypertension Who Experience an Altitude Related Adverse Health Effect (ARAHE) During 30h Exposure to 2500m
Official title: The Impact of Hypoxia on Patients With Precapillary Pulmonary Hypertension and Treatment of Adverse Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Altitude Pulmonary Hypertension
Oxygen Therapy
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 9
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: To study whether oxygen therapy titrated to maintain oxygenation (SpO2) \> 90% at 2500m would resolve altitude-related adverse health effects, symptoms and impaired exercise during 30h exposure to high altitude.

Detailed description: Patients with pulmonary hypertension who reveal an altitude-related adverse health effects at 2500m will be given oxygen therapy by nasal cannula titrated to maintain the oxygen saturation above 90%. The study will investigate, whether this measure will restore altitude-induced impairment to baseline levels at low altitude.

Eligibility criteria: Inclusion Criteria:

* Informed consent as documented by signature
* PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure \>20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization

Exclusion Criteria:

* resting partial pressure of oxygen \<8 kilopascal at Zurich at 490 m low altitude
* exposure to an altitude \>1000 m for ≥3 nights during the last 2 weeks before the study
* inability to follow the procedures of the study
* other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)

Primary outcomes:
measure: Recovery from ARAHE
timeFrame: 30 hours
Secondary outcomes:
measure: Constant work-rate exercise time
timeFrame: 30 hours
measure: Maximum work-rate in incremental ramp cycle exercise tests
timeFrame: 30 hours
measure: Hemodynamics
timeFrame: 30 hours
measure: Borg dyspnoea scale
timeFrame: 30 hours
measure: Visual Analogue Scale
timeFrame: 30 hours
measure: Cognitive testing
timeFrame: 30 hours
measure: sit-to-stand test
timeFrame: 30 hours
measure: Sleep disordered breathing
timeFrame: 30 hours
measure: 6 minute walk test
timeFrame: 30 hours
measure: Acute Mountain Sickness Score
timeFrame: 30 hours
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Respiratory Clinic, University Hospital of Zurich
Study officials:
References:
Clinical trial NCT04233372: Evaluation of (Doravirine / Lamivudine / Tenofovir Disoproxil Fumarate) (Delstrigo®) as a New Strategy for Non-occupational Post Exposure Prophylaxis, a Prospective Open Label Study
Official title: Evaluation of (Doravirine / Lamivudine / Tenofovir Disoproxil Fumarate) (Delstrigo®) as a New Strategy for Non-occupational Post Exposure Prophylaxis, a Prospective Open Label Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hiv
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Dr. Josep Mallolas
First posted: 2020-01-18
Enrollment: 400
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: Subjects who go to emergency room for possible contact to HIV transmission receive Delstrigo as post exposition prophylaxis.


Eligibility criteria: Inclusion Criteria:

* Subjects attending emergency room due to potential HIV exposition of either sex:
* Aged 18 years or more.
* Who have been exposed to non-occupational HIV and who meet the prerequisites for the current recommendations to begin prophylaxis post-exposition with three antiretroviral drugs.
* Who after being fully informed, give their written consent to participate in the study and undergo the tests and examinations required.
* Individuals able to do follow up correctly.

Exclusion Criteria:

* Pregnant women or nursing mothers or women trying to conceive during the study period.
* Patients in whom it is known or suspected that the source case has a resistance to one of the drugs from the study treatment regimens.
* Treatment with drugs that are contraindicated in the study or products that are in the investigational phase.
* Allergic reactions or intolerance to the compounds of the study treatment regiments

Primary outcomes:
measure: Proportion of subjects with treatment completion at day 28
timeFrame: 28 days
Secondary outcomes:
measure: Assess the baseline characteristics associated to non-completion.
timeFrame: 28 days
measure: Incidence and description of adverse reactions(clinical and laboratory) that appear during antiretroviral therapy
timeFrame: 28 days
measure: Description of adherence to combination antiretroviral therapy, including the time until loss of adherence
timeFrame: 28 days
measure: Proportion of subjects that maintain follow-up
timeFrame: 12 weeks
measure: Rate of HIV Seroconversion
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Nantes
country: France
facility: Department and HIV & HCV Clinical Research Unit University Hospital Nantes
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
Study officials:
References:
Clinical trial NCT01450072: Prospective Randomized Endovascular Therapy in Multiple Sclerosis - PREMiSE
Official title: Prospective Randomized Endovascular Therapy in Multiple Sclerosis - PREMiSE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2011-10-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Departments of Neurology and Neurosurgery are conducting this research study to evaluate the safety and effectiveness of intravascular angioplasty for the treatment of venous narrowing in the treatment of Multiple Sclerosis (MS).


Eligibility criteria: Inclusion Criteria:

* Age 18-65 years
* EDSS 0-6.5 (0-5.5 in the phase II of the study)
* Diagnosis of relapsing MS according to the McDonald criteria (Polman et al., 2005)
* 1 relapse within the past 12 months or GAD positive lesion on an MRI within the past 3 months (only for phase II of the study)
* Be on treatment with currently FDA approved disease-modifying treatments (excluding Tysabri or steroids (within the last 30 days prior to enrollment)
* Evidence of ≥2 sonographic parameters of suspicious abnormal extracranial cerebral venous outflow (see Table 1 background and 1.5 section)
* Normal renal function: creatinine clearance level of \>60

Exclusion Criteria:

* Relapse, disease progression and Tysabri and steroid treatment in the 30 days preceding study entry
* Pre-existing medical conditions known to be associated with brain pathology (e.g., neurodegenerative disorder, cerebrovascular disease, positive history of alcohol abuse, etc.)
* Severe peripheral chronic venous insufficiency
* Abnormal renal function
* Contrast allergy (anaphylaxis)
* Not accepting to undergo the endovascular treatment
* Peripheral Vascular Disease

Primary outcomes:
measure: Percentage of Patients With Immediate and Short-term SAE
timeFrame: 24 hours-1 month
Secondary outcomes:
measure: Number of Participants With More Than 75% of Normal Outflow at 1 Year Post-angioplasty
timeFrame: 1 month, 3 months, 6 months, and 1 year post-angioplasty
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo Neurosurgery
state: New York
Study officials:
affiliation: University at Buffalo Neurosurgery
name: Adnan Siddiqui, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Siddiqui AH, Zivadinov R, Benedict RH, Karmon Y, Yu J, Hartney ML, Marr KL, Valnarov V, Kennedy CL, Ramanathan M, Ramasamy DP, Dolic K, Hojnacki DW, Carl E, Levy EI, Hopkins LN, Weinstock-Guttman B. Prospective randomized trial of venous angioplasty in MS (PREMiSe). Neurology. 2014 Jul 29;83(5):441-9. doi: 10.1212/WNL.0000000000000638. Epub 2014 Jun 27.
Clinical trial NCT06703372: Photobiomodulation In Treatment Of Xerostomia In Type Ii Diabetic Patients
Official title: Effectiveness Of Photobiomodulation In Treatment Of Xerostomia In Type Ii Diabetic Patients (A Randomized, Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Xerostomia
Diabetes Mellitus
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-11-25
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Xerostomia is a major oral health problem that if not recognized and treated can have a significant effect on a patient's quality of life. It leads to difficulties with speech, swallowing and taste alteration. Pathological causes of xerostomia are divided into local and systemic factors. Local factors include smoking, salivary gland diseases and head and neck radiation therapy. Systemic factors include autoimmune diseases as Sjögren syndrome and hormonal disorders as Diabetes Mellitus. Photobiomodulation (PBM) previously known as Low Level Laser Therapy (LLLT) is the application of red and near infra-red light over injuries or lesions to improve wound and soft tissue healing, reduce inflammation and give relief for both acute and chronic pain. It also has grabbed the attention over the last few years as an effective treatment for xerostomia.


Eligibility criteria: Inclusion Criteria:

* Patients with type 2 diabetes mellitus suffering from xerostomia and on oral hypoglycemic drugs.
* Glycated hemoglobin less than 7%.
* Duration of diabetes mellitus not less than 4 years and not more than 8 years

Exclusion Criteria:

* Patients receiving any drugs that cause hyposalivation.
* Patients with any systemic disease reported to produce hyposalivation (sjogren's syndrome, hepatitis c, rheumatoid arthritis and lupus erythematosus).
* Patients receiving chemotherapy and radiotherapy.
* Individuals with skin lesions in the treatment zone to avoid any complications occurring in this area by laser exposure

Primary outcomes:
measure: Change in severity of xerostomia
timeFrame: baseline, 2 weeks, 4 weeks, 6 weeks and 12 weeks
measure: Change in unstimulated salivary flow rate
timeFrame: baseline, 2 weeks, 4 weeks, 6 weeks and 12 weeks
measure: Change in stimulated salivary flow rate
timeFrame: baseline, 2 weeks, 4 weeks, 6 weeks and 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt
Study officials:
References: