louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03750331: Impact of the Use of Remote Monitoring in the Follow-up of the Renal Transplant Patient.
Official title: Impact of the Use of Remote Monitoring in the Follow-up of the Renal Transplant Patient.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Renal Transplantation
Keywords: telemedicine
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2018-11-23
Enrollment: 738
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-inferiority Randomized Controlled Trial comparing Non-inferiority Randomized Controlled Trial comparing (i) a group of renal transplant outpatients consulting their Transplant Centre following a traditional schedule (every other week up to 6 months post-transplant, once a month up to year 1, every three months up to year 2 and every 6 months thereafter) to (ii) a group of patients assisted by Ap'TELACARE and consulting their Transplant Centre following a less stringent schedule of consultations (every month up to 6 months, every other month up to year 1, every six months up to year 2 and once a year thereafter).
Primary purpose: OTHER

Brief summary: Transplant Centers are facing new organisational challenges with regards to the growing number of patients they have to follow-up. We have developed and assessed the feasibility of using a novel web application permitting a medically-tailored follow-up of stable renal transplanted outpatients: Ap'TELECARE. This novel approach is likely to facilitate the organization of patients' follow-up at the Transplant Centre level as well as to provide secondary individual benefits in terms of therapeutic education, adherence to treatment and eventually to improve long term outcome.


Eligibility criteria: Inclusion Criteria:

* Patients transplanted for at least 3 months
* Stable renal graft function

Exclusion Criteria:

* No home internet access
* Major disability

Primary outcomes:
measure: Patients experiencing at least one episode of graft dysfunction
timeFrame: 2 years
Secondary outcomes:
measure: Failure of immunosuppressive treatment
timeFrame: 2 years
measure: number of patients who needed to return to dialysis
timeFrame: 2 years
measure: number of patients with acute or chronic transplant rejection
timeFrame: 2 years
measure: Post-transplant complication
timeFrame: 2 years
measure: Death
timeFrame: 2 years
measure: Quality of life assessed
timeFrame: 2 years
measure: Level of anxiety and depression
timeFrame: 2 years
measure: Incremental cost-effectiveness evaluation criteria
timeFrame: 2 years
measure: Evaluation criteria for the Budget Impact Analysis
timeFrame: 2 years
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand, CHU Site Gabriel-Montpied
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Christophe Mariat, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06533631: Measuring Brain Health Using Low-Field Portable MRI
Official title: Measuring Brain Health Using Low-Field Portable MRI
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: White Matter Hyperintensity
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2024-08-01
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants, age 50+, with risk factors for white matter hyperintensities, including hypertension, hyperlipidemia and diabetes. Patients may be identified through flyers distributed among outpatient clinics at Yale-New Haven Hospital for general neurology, internal medicine, and preventive cardiology.

Brief summary: The purpose of this study is to develop a new grading scale and utilize automated segmentation for measurement of White Matter Hyperintensity (WMH) volume using a low field MRI.

Detailed description: This study will take place in one visit, if feasible. This visit will take approximately 2 hours. (Alternatively, the visit can be split over two visits if the subject cannot tolerate two consecutive scans. The pMRI and 3T MRI can occur up to one month apart.)

The purpose of this study is to create both a qualitative lowfield WMH scale that can be used widely and a machine learning enabled quantitative measurement of WMH for more sophisticated applications. To ensure the reliability of these WMH measurement systems, participants will receive both a pMRI and high-field 3T MRI at a single study visit for the purpose of comparing WMH measurements against a gold standard (3T MRI). Using the Delphi method, an expert panel of pMRI researchers will develop the low-field WMH grading scale, iteratively refine it, and validate it within this cohort. Parallel to this, advanced machine learning methodologies will be utilized in this cohort, allowing for precise quantification of WMH volume on pMRI.

Eligibility criteria: Inclusion Criteria:

* One vascular risk factor, from the following:

  1. Hypertension (defined as taking an antihypertensive medication)
  2. Hyperlipidemia (defined as taking a statin or PCSK9 inhibitor)
  3. Diabetes (defined as taking a medication to prevent hyperglycemia)

Exclusion Criteria:

* 1. History of stroke
* History of dementia or other cognitive impairment
* Pacemaker or other MRI contraindications according to the American College of Radiology guidelines

Primary outcomes:
measure: WMH graded on a low-field WMH scale
timeFrame: 2 hours
Secondary outcomes:
measure: WMH lesion load (in mm3)
timeFrame: 2 hours
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Magnetic Resonance Research Center (MRRC) at The Analyn Center (TAC)
state: Connecticut
Study officials:
affiliation: Yale University
name: Adam H de Havenon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03953131: Gallium Ga 68-DOTATATE PET/CT in Predicting Tumor Growth in Patients With Meningiomas
Official title: A Pilot Study of 68Ga-Dotatate PET CT for Radiation Treatment Response Assessment in Meningiomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Meningioma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-05-16
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This phase I trial studies how well gallium Ga 68-DOTATATE positron emission tomography (PET)/computed tomography (CT) works in predicting tumor growth in patients with meningiomas. Giving Gallium Ga 68-DOTATATE before PET/CT scan may work better in predicting tumor growth in patients with meningiomas.

Detailed description: PRIMARY OBJECTIVES:

I. To assess the ability of imaging with gallium Ga 68-DOTATATE (68Ga-DOTATATE) positron emission tomography/computed tomography (PET/CT).

II. To assess a metabolic response to radiation therapy in meningiomas as measured by a reduction in the tumor to background ratio of the maximum standardized uptake values (SUV) of the tumor compared to background brain parenchyma.

OUTLINE:

Patients receive gallium Ga 68-DOTATATE intravenously (IV) over a few minutes and, after 60 minutes, undergo a PET/CT scan over 5-10 minutes 14 days before starting scheduled radiation therapy and 6 weeks after completion of radiation treatment.

Eligibility criteria: Inclusion Criteria:

* Any meningioma with at least 10 mm measurable residual disease.
* Age 18 years or older.
* Planned radiation therapy for meningioma.
* Ability to understand and the willingness to sign a IRB approved written informed consent document in accordance with regulatory and institutional guidelines before study entry.
* No restriction based on language that would prohibit enrollment of the participant. IRB approved VTPS form will be utilized when non-English Speaking patient is enrolled

Exclusion Criteria:

* Neurofibromatosis type 1 or 2.
* Children.
* Pregnant.
* Contraindication to MR imaging.
* Body weight greater than 400 lbs (181.4kg).

Primary outcomes:
measure: Imaging with Gallium Ga 68-DOTATATE
timeFrame: Up to 1 year
measure: Metabolic response to radiation therapy
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jason M Johnson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05848531: Clonidine With Morphine in Patient Controlled Analgesia Pump in Vaso-Occlusive Crisis in Sickle Cell Disease Patient
Official title: Advantage of Clonidine With Morphine In Patient Controlled Analgesia Pump for the Treatment of Vaso-occlusive Crisis in Sickle Cell Disease Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Sickle Cell Disease
Vaso-occlusive Pain Episode in Sickle Cell Disease
Keywords: Clonidine
Morphine
Acute Pain management
patient controlled analgesia
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double Blinded, randomised, prospective
Primary purpose: TREATMENT

Brief summary: Vaso-occlusive crisis are highly painful in Sickle-cell patients. Morphine is the treatment of choice for this pain. Various adjuncts have been studied for the treatment of vaso-occlusive crisis.

The investigators aimed to study the effect of clonidine associated with morphine in PCIA (patient controlled intravenous analgesia pumps) regimen. The investigators will compare it to the morphine alone in PCIA for the treatment of vaso-occlusive pain.

The investigators will measure the morphine consumption of all patient, the impact on the apparition of the morphine secondary effect and on inflammation biomarkers and the biopsychosocial respond.

Each patient will be hospitalized and follow by haematologist from the hospital, pain doctors and nurses.

It will be a double blind randomised, prospective study. The randomisation will be done by the pharmacy.


Eligibility criteria: Inclusion Criteria:

* Vaso-Occlusive Crisis In Sickle Cell disease Patients

Exclusion Criteria:

* Minor
* Patient's refusal
* Pregnancy
* Contr-indication Clonidine therapy

Primary outcomes:
measure: Morphine Consumption
timeFrame: Up to two weeks
Secondary outcomes:
measure: Numerical Rating Scale
timeFrame: Up to two weeks
measure: Biology markers
timeFrame: Up to two weeks
measure: Biopsychosocial model / ASCQ-ME questionary
timeFrame: Up to two weeks
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: CHU Saint-Pierre
Study officials:
References:
citation: Kenney MO, Smith WR. Moving Toward a Multimodal Analgesic Regimen for Acute Sickle Cell Pain with Non-Opioid Analgesic Adjuncts: A Narrative Review. J Pain Res. 2022 Mar 31;15:879-894. doi: 10.2147/JPR.S343069. eCollection 2022.
Clinical trial NCT02828631: A Comparison of McGrath, Pentax and Macintosh Laryngoscopes for Nasotracheal Intubation in Pediatrics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation Time
Intubation Difficulty Scale
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 108
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Videolaryngoscope provide better view of the larynx. This better view could improve the navigation of endotracheal tube in nasotracheal intubation. Contrast to the improved result in adult, one previous report using Glidescope in children did not show better performance than direct laryngoscope. The aim of this study is to compare the performance of McGrath, Pentax and Macintosh laryngoscope for nasotracheal intubation in children.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist physical status class I, II

Exclusion Criteria:

* abnormality of airway
* bleeding tendency

Primary outcomes:
measure: time to intubation
timeFrame: 2 min
Secondary outcomes:
measure: intubation difficulty scale
timeFrame: immediately after intubation
Other outcomes:
Locations:
city: Suwon-si
country: Korea, Republic of
facility: Ajou universitiy school of medicine
state: Gyeong-gi Do
Study officials:
References:
Clinical trial NCT00501631: ALK21-014: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) After Enforced Abstinence
Official title: Efficacy and Safety of VIVITROL® in Adults Completing Inpatient Treatment for Alcohol Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alcohol Dependence
Keywords: Addiction
Alcoholism
Inpatient detoxification
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2007-07-16
Enrollment: 300
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: VIVITROL is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL. This Phase 3B trial was designed to evaluate the efficacy and safety of VIVITROL versus placebo. Injections were administered to patients in whom abstinence was enforced by a period of inpatient hospitalization of 7 to 21 days.

Detailed description: The study consisted of 2 parts, Part A and Part B. Part A was a double-blind, placebo-controlled assessment of safety and efficacy of VIVITROL versus placebo for 3 months. Part B was an open-label extension to assess longer-term safety, durability of effect, and health economics of VIVITROL when administered for up to 9 additional months.

Eligibility criteria: Primary Inclusion Criteria:

* Current diagnosis of alcohol dependence, meeting at least 5 of DSM-IV criteria
* Expected to complete inpatient treatment for alcohol dependence within 24 hours of randomization
* Must have 7-21 days, inclusive, of inpatient treatment for alcohol dependence prior to first dose
* Negative urine toxicological screen for opioids on the day of randomization
* Women of childbearing potential must agree to use an approved method of contraception for the study duration

Primary Exclusion Criteria:

* Pregnancy or lactation
* Evidence of hepatic failure including: ascites, bilirubin \>10% above upper limit of normal and/or esophageal variceal disease
* Current dependence (within the past year) to benzodiazepines, opioids or cocaine by DSM-IV criteria
* Use of any opioids and/or methadone within 14 days prior to the screening visit, or subjects likely to require opioid therapy during the study period
* Use of oral naltrexone, acamprosate, or disulfiram within 14 days prior to screening
* Known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or PLG
* Parole, probation, or pending legal proceedings having the potential for incarceration during the study period

Primary outcomes:
measure: Cumulative Percentage of Participants by Heavy Drinking Rate
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Longer-term Safety of VIVITROL
timeFrame: up to 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Alkermes, Inc.
name: Bernard L. Silverman, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00521131: Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites
Official title: Evaluation of Efficacy, Using the Number of Comfortable Days and the Safety of Levocetirizine Dihydrochloride, Administered Once Daily in the Evening for 30 Days, to Subjects Suffering From Perennial Allergic Rhinitis to House Dust Mites
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rhinitis
Allergic
Perennial
Keywords: Levocetirizine dihydrochloride
Xyzal tablets
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-08-27
Enrollment: 453
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites


Eligibility criteria: Inclusion Criteria:

* male or female ≥ 12 years
* suffering from a perennial allergic rhinitis to house dust mites for at least 2 years
* positive skin test or positive Radio-Allergo-Sorbent-Test for house dust mites
* the mean of the T4SS evaluated in the evening over the last 24 hours of the selection period was ≥ 5

Exclusion Criteria:

* seasonal allergic rhinitis likely to change significantly the symptoms of the subject
* an ear, nose or throat (ENT) infection during the two weeks preceding initial visit
* asthma requiring corticosteroid treatment
* atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or topical corticosteroids
* associated ENT disease

Primary outcomes:
measure: Number of comfortable days, as assessed by the subject
timeFrame: 30 days
Secondary outcomes:
measure: Sum of 4 and 5 rhinitis symptoms and safety
timeFrame: Week 1 and over 30 days
Other outcomes:
Locations:
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06328582: Acupuncture Technique for Restoring Consciousness on Post-stroke Dysphagia
Official title: Clinical Effect of Acupuncture Technique for Restoring Consciousness Combined With Scalp Acupuncture on Post-stroke Dysphagia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dysphagia
Lead sponsor: Chao Phya Abhaibhubejhr Hospital
Sponsor class: OTHER_GOV
First posted: 2024-03-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a randomized controlled study, including post-stroke dysphagic patients. The participants were divided randomly into the experimental group and the control group. Both two groups were given routine treatment and swallowing rehabilitation training. Moreover, the experimental group was given Acupuncture Technique for Restoring Consciousness. Swallowing function will be compared before and after treatment.

Detailed description: This is a randomized controlled study, including post-stroke dysphagic patients. The participants were divided randomly into the experimental group and the control group. Both two groups were given routine treatment and swallowing rehabilitation training. Moreover, the experimental group was given Acupuncture Technique for Restoring Consciousness. Swallowing function will be compared before and after treatment.

Specifically, our main focus is on Neiguan, Renzhong and Sanyinjiao.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years.
* Meeting the diagnostic criteria for stroke.
* Diagnosed with dysphagia confirmed by the video fluoroscopic swallowing study.
* Water swallow test\> Level 3.
* Stable vital signs, conscious, able to cooperate with assessment and treatment.

Exclusion Criteria:

* Dysphagia possibly caused by other reasons, such as cerebrovascular disease, trauma, neuromuscular diseases, malignant diseases of the pharynx and larynx, and digestive tract diseases.
* History of mental diseases or use of antipsychotics.
* Complicated with cognitive impairment or consciousness dysfunction.
* Simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases.

Primary outcomes:
measure: Penetration-Aspiration Scale
timeFrame: day 1 and day 28
Secondary outcomes:
measure: Functional Oral Intake Scale
timeFrame: day 1 and day 28
measure: Gugging Swallowing Screen
timeFrame: day 1 and day 28
Other outcomes:
Locations:
Study officials:
affiliation: Site Coordinator of United Medical Group
name: Nieto Luis, Master
role: STUDY_CHAIR
References:
Clinical trial NCT06455982: Reduced Carbohydrates + Ketogenic Supplement on Energy Metabolism
Official title: Effect of a Reduced Carbohydrates Menu Combined With a Ketogenic Supplement on Energy Metabolism in a Senior Residence: the SAGE-2 Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy Aging
Keywords: Nutritional intervention
Glucose monitoring
Reduced carb diet
Energy metabolism
Ketones
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Nestlé Health Science
First posted: 2024-06-13
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will be compared to themselve (i.e. pre-intervention and post-intervention) The intervention will be 2 months of reduced carbohydrate menu combined with a ketogenic supplement (MCT)
Primary purpose: PREVENTION

Brief summary: The present study will evaluate the effects on glucose, ketones and other blood biomarkers, cognition, quality of life, physical activity and well-being of a reduced carbohydrate diet paired with a ketogenic product for 2 months in a population living in a senior residence. This study follows the KetoHome (fall 2022) and SAGE (fall 2023) projects which assessed the feasibility, acceptability and effectiveness of a reduced carbohydrate intervention alone.


Eligibility criteria: Inclusion Criteria:

* Older men or women in a senior residence;
* Understand, read and write French;
* Have sufficient visual and hearing acuity to pass cognitive tests;
* Available during the intervention period

Exclusion Criteria:

* Body mass index \< 20;
* T1 diabetic;
* T2 insulin-dependent diabetic;
* MMSE \< 20;
* Weight loss \>10% in the last 6 months involuntary or voluntary;
* Known and uncontrolled hypoglycemia;
* Moderate to severe digestive illnesses that can be aggravated by dietary changes;
* Severe dysphagia;
* Supplementation with MCT oil, ketone salts, ketone esters, adherence to the ketogenic diet, reduced carbohydrate diet, intermittent fasting or other diet or supplements that can significantly increase ketones in the last month;
* Participation in other interventional research projects on nutrition or aimed at metabolic change simultaneously.
* Medical condition that could prevent the participant from completing the study in the opinion of the doctor

Primary outcomes:
measure: Plasma glucose concentration
timeFrame: 2 months
measure: Plasma ketones concentration
timeFrame: 2 months
measure: Plasma insulin concentration
timeFrame: 2 months
Secondary outcomes:
measure: Plasma triglycerides concentration
timeFrame: 2 months
measure: Plasma cholesterol concentration
timeFrame: 2 months
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre de recherche sur le vieillissement
state: Quebec
Study officials:
References: