louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05621590: MLC901 in Hypoxic-ischemic Brain Injury Patients; A Double-blind, Randomized Placebo-controlled Trial
Official title: MLC901 in Hypoxic-ischemic Brain Injury Patients; A Double-blind, Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Hypoxic Ischaemic Encephalopathy Due to Cardiac Arrest
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2022-11-18
Enrollment: 35
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In a randomized, placebo-controlled trial, 35 patients with HIBI were randomly designated to receive either MLC901 or placebo capsules over six months.

We evaluated patients in two groups by modified Rankin Scale (mRS) and Glasgow outcome scale (GOS) to examine their state of disability and recovery


Eligibility criteria: Inclusion Criteria:

* an initial cardiac arrest leading to coma, successful return of spontaneous circulation, and persistent coma after the return of spontaneous circulation.

Exclusion Criteria:

* pregnancy, cardiogenic shock (systolic blood pressure less than 90 mm Hg despite epinephrine infusion), possible causes of coma other than cardiac arrest (drug overdose, head trauma, or cerebrovascular accident), an underlying background of known acute or chronic disease including renal failure, liver or pulmonary disorders, previous stroke, dementia, and brain injury.

Primary outcomes:
measure: neurofunctional outcome using Glasgow Outcome Scale (GOS)
timeFrame: 6 months
measure: neurofunctional outcome using modified Rankin Scale (mRS)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Shahid Beheshti University of Medical Sciences, Shohada Hospital
Study officials:
References:
citation: Pakdaman H, Amini Harandi A, Gharagozli K, Abbasi M, Ghaffarpour M, Ashrafi F, Delavar Kasmaei H, Amini Harandi A. MLC601 in vascular dementia: an efficacy and safety pilot study. Neuropsychiatr Dis Treat. 2017 Oct 5;13:2551-2557. doi: 10.2147/NDT.S145047. eCollection 2017.
Clinical trial NCT03579290: Feasibility of Providing Computerized CBT in the Black Church
Official title: A Pilot Feasibility Study of Providing Substance Use Treatment in the Black Church
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Abuse
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
First posted: 2018-07-06
Enrollment: 40
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 investigator will conduct a pilot study evaluating the feasibility and acceptability of providing a computer-based program (CBT4CBT), used for the treatment of substance use disorders, in a church setting.

Detailed description: The investigator will conduct a pilot study evaluating the feasibility and acceptability of providing a computer-based program (CBT4CBT), used for the treatment of substance use disorders, in a church setting. Forty Black adults with a current DSM-5 alcohol or substance use disorder will utilize the 'CBT for CBT' program over a period of 8 weeks. Primary outcomes will be acceptability and feasibility of providing the treatment in a church setting. If found to be acceptable and feasible, with preliminary promise for reductions in substance use, the next step would be to adapt the computer intervention for this population and conduct a randomized controlled trial.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Has at least one SUD diagnosis as defined by the DSM 5

Exclusion Criteria:

* Are unable provide informed consent or participate in the study procedures as proposed in the consent
* Active suicidal or homicidal ideation
* Current engagement in substance use treatment
* Have a current legal case pending, such that incarceration during the 8 week protocol is likely
* Are in need of detoxification from alcohol, opioids or benzodiazepines

Primary outcomes:
measure: Recruitment Feasibility
timeFrame: 8 weeks
measure: Program Acceptability
timeFrame: 8 weeks
measure: Sessions Attended
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Dixwell Ave Congregational United Church of Christ
state: Connecticut
Study officials:
affiliation: Yale University
name: Ayana Jordan, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04775290: Yoga on QOL Physiological Distress&Fatigue, on Patients Affected by Breast Cancer in Adjuvant Radiotherapy
Official title: Monocentric, Randomized Clinical Trial About the Effect of Yoga Practice on QOL, Physiological Distress and Fatigue, on Patients Affected by Breast Cancer Undergoing Adjuvant Radiotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Female Breast Cancer
Fatigue
Quality of Life
Physiological Stress
Radiotherapy; Complications
Keywords: Female Breast Cancer
Fatigue
Quality of Life
Physiological Stress
Radiotherapy; Complications
Lead sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study aims to investigate, through serial measurements of some biomarkers, the potential mechanisms through which yoga impacts on QOL and fatigue.

Detailed description: The study aims to assess QoL, fatigue and physiological distress (cortisol and proinflammatory markers) with blood sampling on day 1,15 and last of radiotherapy, at 1-3-6 months after the end of radiotherapy.

Patients with breast cancer who will undergo radiotherapy will be randomly assigned to the yoga group (YG) or the control group (CG).

Patients in the YG will participate in 2 weekly yoga classes during the 5 weeks of radiation therapy. The classes will be coordinated with the treatment program and will be held in the vicinity of the radiation therapy center.

Eligibility criteria: Inclusion Criteria:

* Women with stage 0-III breast cancer who have undergone adjuvant daily radiotherapy for 5 weeks in Istituto Scientifico Romagnolo per lo studio e la cura dei Tumori (IRST) Department of Radiation Oncology of Meldola.

Exclusion Criteria:

* Patients with documented diagnosis of mental disorders (eg Schizophrenia)
* Patients with stage IV disease
* Patients with active or non-canalised deep vein thrombosis
* Patients not undergoing surgery for the basic oncological disease
* Patients with mobility problems (eg unable to get up from the chair)
* Patients who have practiced yoga or are practicing yoga in the 6 months before the cancer diagnosis.
* Patients diagnosed with lymphedema

Primary outcomes:
measure: Change of physiological distress
timeFrame: up to 32 months
Secondary outcomes:
measure: Evaluation of quality of life with yoga during and after radiotherapy
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Meldola
country: Italy
facility: IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST s.r.l.
state: Forlì-Cesena
Study officials:
affiliation: IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.
name: Simona Micheletti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03034590: How to Identify Fatigue in Stroke Patients
Official title: How to Identify Fatigue in Stroke Patients: Validity of the Post-stroke Fatigue Case Definition
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Stroke Fatigue
Stroke
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2017-01-27
Enrollment: 70
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: stroke patients with a new stroke within 120 days

Brief summary: This study will translate an English case definition of poststroke fatigue and validate it against the Multidimensional Fatigue Questionnaire-20 and the Fatigue Severity Scale


Eligibility criteria: Inclusion Criteria:

Patients with a clinical stroke within the last 6 months as judged by a senior doctor or by the research assistant.

Patients that have given written informed consent

-

Exclusion Criteria:

Patients with aphasia, dementia or cognitive deficits so severe that they are unable to understand the purpose of the interview and the questionnaire. -

Primary outcomes:
measure: Mean MFI-20 score for case positive patients
timeFrame: at inclusion in the trial
measure: Mean FSS-7 score for case positive patients
timeFrame: At inclusion in the trial
Secondary outcomes:
measure: inter rater variability of the case definition
timeFrame: within a week
measure: Optimal cut off score for case positiveness on MFI-20 and FSS
timeFrame: at inclusion in the trial (which is the time the values used are measured)
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Department of Neurology, Herlev Hospital
Study officials:
affiliation: Department of Neurology, Herlev Hospital
name: Karsten Overgaard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00971490: Effects of a 4-week Acu-Transcutaneous Electrical Nerve Stimulation (Acu-TENS) Program on Subjects With Stable Chronic Obstructive Pulmonary Disease (COPD)
Official title: Effects of a 4-week Acu-Transcutaneous Electrical Nerve Stimulation (Acu-TENS) Program on Subjects With Stable Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
FEV1
beta endorphin
SGRQ
Acu-TENS
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2009-09-03
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objectives of this study are to investigate the effectiveness of Acu-TENS (transcutaneous electrical nerve stimulation applied on acupoints) on lung functions and quality of life and to explore the associated underlying mechanisms in subjects with COPD.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis with COPD

Exclusion Criteria:

* allergic to gel
* unable to perform spirometry
* unable to communicate
* no history of infection or exacerbation of respiratory symptoms

Primary outcomes:
measure: Forced expiratory volume in one second (FEV1), forced vital capacity (FVC)
timeFrame: measured before and after the 4-week program
Secondary outcomes:
measure: beta endorphin, St George Respiratory Questionnaire (SGRQ)
timeFrame: measured before and after the 4-week program
Other outcomes:
Locations:
city: Shatin, Hong Kong
country: China
facility: Prince of Wales Hospital
Study officials:
References:
Clinical trial NCT00547690: Acupuncture in Stroke Rehabilitation
Official title: Electro-acupuncture and Strengthening Exercise for Hemiplegic Elbow and Wrist Joints
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Stroke
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2007-10-22
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary purpose of the study is to examine the effect of acupuncture treatment when combined with strength training on the motor functional recovery of stroke survivors

Detailed description: In this study, we compare the effect on motor functional improvement between a combined acupuncture and strength training program and the strength training alone. The results may allow us to determine whether the acupuncture may bring in additional benefit to the motor recovery in the upper limb in stroke survivors

Eligibility criteria: Inclusion Criteria:

* After stroke (\>6 months)

Exclusion Criteria:

* Other neurological diseases

Primary outcomes:
measure: Fugl-Meyer Motor Scores
timeFrame: Before and After 6 Week Treatment
Secondary outcomes:
measure: Active wrist ROM
timeFrame: Before and After 6 Week Treatment
measure: Quantitative Measure of Muscle Spasticity
timeFrame: Before and After 6 Week Treatment
measure: Ashworth Score
timeFrame: Before and After 6 Week Treatment
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Wen Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00161590: Study of CHOP + Campath for T-Cell, Null Cell, or Natural Killer (NK)-Cell Lymphoma
Official title: Phase I Study of CHOP Plus Campath (C-CHOP) for the Treatment of T-Cell, Null-Cell, and NK-Cell Lymphomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: T-Cell Lymphoma
Lymphoma, Non-Hodgkin's
Keywords: NK cell lymphoma
Null cell lymphoma
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2005-09-12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary Objective:

* To determine the toxicity profile and tolerability of alemtuzumab (Campath) when administered in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy (C-CHOP) in patients with T-cell, null-cell and NK-cell lymphomas.

Secondary Objectives:

* To evaluate response rate, overall survival, and disease-free survival in patients with T-cell, null-cell, and NK-cell lymphomas treated with Campath + CHOP chemotherapy.
* To assess the incidence of cytomegalovirus (CMV) reactivation in patients with these lymphomas treated with the Campath + CHOP combination.
* To determine features which might be predictive of resistance to treatment or predictive of relapse, including the absence of glycosylphosphatidylinositol (GPI)-linked proteins.


Eligibility criteria: Inclusion Criteria:

* Patients must have a diagnosis of non-B-cell, non-Hodgkin's lymphoma (including T-cell, null-cell, or NK-cell lymphoma, but excluding lymphoblastic lymphoma)
* Stage II, III, or IV disease requiring chemotherapy
* At least one site of measurable disease, 1.5 cm in diameter or greater
* Age \> or = 18 years
* Absolute granulocyte count of at least 1500 cells/mm3, unless neutropenia is due to marrow infiltration by the tumor
* Platelet count of at least 100,000 cells/mm3 unless thrombocytopenia is due to marrow infiltration by tumor
* Creatinine less than 2 x upper limits of normal (ULN)
* Total bilirubin less than 2 x ULN (dose reduced vincristine and adriamycin required for bilirubin \> 1.2 mg/dL)
* Echocardiogram (Echo) or multiple gate acquisition scan (MUGA) documenting a normal ejection fraction prior to chemotherapy
* Able to give informed consent

Exclusion Criteria:

* Known central nervous system (CNS) involvement
* Known HIV disease
* Patients who are pregnant or nursing
* Any factor which might limit the patient's ability to provide informed consent
* Life expectancy \< 3 months
* Patients who are unwilling to agree to use an effective means of birth control while on treatment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Richard Furman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00703690: MK0767 in Metabolic Syndrome-Dyslipidemia (0767-016)
Official title: A Multicenter, Double-Blind, Randomized, Placebo and Active-Controlled, Parallel Study to Evaluate the Lipid Altering Efficacy and Safety of MK0767 in Patients With Metabolic Syndrome and Dyslipidemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Metabolic X Syndrome Dyslipidemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-06-23
Enrollment: 436
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a clinical trial in patients with Metabolic Syndrome and Dyslipidemia to study the effects of MK0767 on triglycerides.


Eligibility criteria: Inclusion Criteria:

* Patients with Metabolic Syndrome and Dyslipidemia age 21 to 65
* Patients will be eligible for the study if their triglyceride levels are within protocol specified range and have at least 2 of the criteria for Metabolic Syndrome as defined by NCEP

Exclusion Criteria:

* Patients with a history of diabetes mellitus, partial ileal bypass, intolerant to fibric acid derivatives, requiring continuous oral corticosteroids, taking anti-seizure medications, documented coronary heart disease, renal insufficiency, proteinuria, viral hepatitis, cholelithiasis or other gallbladder disease, pancreatitis, neoplastic disease
* Patient is on cyclical estrogen medications
* Patient has taken lipid-lowering agents including fibric acid derivatives, bile acid sequestrants, HMG CoA reductase inhibitors and nicotinic acid derivatives within 8 weeks or probucol within 1 year of prior to visit 2

Primary outcomes:
measure: a dose-response will be seen across the doses of MK0767 and placebo in lowering fasting triglyceride.
timeFrame: After 12 weeks of treatment
Secondary outcomes:
measure: MK0767 will be safe and well tolerated
timeFrame: throughout study and at 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05223790: Assessment of the NIPE in Very Premature Infant Ventilated and Sedated in Neonatal Reanimation.
Official title: Assessment of the NIPE in Very Premature Infant Ventilated and Sedated in Neonatal Reanimation.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neonatal
Pain Measurement
Reanimation
Keywords: NIPE
Newborn Infant Parasympathetic Evaluation
Pain measurement
Neonatal care
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 50
Sex: ALL
Minimum age (years): 0
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infant born very premature and aged less than 8 days ventilated and sedated in neonatal reanimation

Brief summary: The Newborn Infant Parasympathetic Evaluation (NIPE) was developed as a method of analysis of the heart rate variability. The monitor gives a value between 0 (low value of the parasympathetic component) and 100 (high value of the parasympathetic component).

So far, the measure of the heart failure variability by using the NIPE in infant born very premature ventilated and sedated in neonatal reanimation has not been realised and validated as an evaluation method of the pain and discomfort related to neonatal care.


Eligibility criteria: Inclusion Criteria:

* Infant born very premature before 34 weeks of amenorrhoea + 0 day
* Age ≤ 7 days
* Admitted in neonatal reanimation
* Sedated, intubated, ventilated

Exclusion Criteria:

* High frequency oscillation ventilation
* Heart rate non sinusal
* Inotropes and atropine
* Opposition from the guardian of parental authority
* Difficulty of comprehension or communication making the parental information impossible

Primary outcomes:
measure: Variation of the NIPE measures between before and during care.
timeFrame: From 10 minutes before the care to 10 minutes after the beginning of the care
Secondary outcomes:
measure: Correlation between the variation of the NIPE measures and the variation of PIPP-R behavioural scale between each period
timeFrame: From 10 minutes after the beginning of the care to 10 minutes after the end of the care
measure: Correlation between the NIPEmin and the PIPP-R behavioural scale for each period
timeFrame: From 10 minutes before the care to 10 minutes after the care
measure: The discriminant power of the NIPE to split the painful population and the non-painful population determined by a threshold at 6 on the PIPP-R scale
timeFrame: From 10 minutes before the care to 10 minutes after the care
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Jeanne de Flandre Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Riadh Boukris, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06709690: A Fast, Quiet, Artificial Intelligence-based PET/MR Solution for Paediatric Diseases
Official title: A Fast, Quiet, Artificial Intelligence-based PET/MR Solution for Paediatric Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Paediatric Patients
Keywords: 18F-FDG PET/MR
pediatric
silent scan
flexible coil
deep learning
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 35
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients and outpatients at Ruijin Hospital who meet the inclusion criteria.

Brief summary: To investigate the feasibility of deep learning-assisted rapid silent PET/MR in pediatric applications.

Detailed description: This study aims to address the challenges faced by PET/MR in pediatric applications by leveraging new technologies such as flexible coils, silent sequences, and deep learning-based image reconstruction. The objective is to provide a rapid, silent, comfortable, and half-dose PET/MR imaging solution for pediatric patients, and to demonstrate its feasibility in this patient population.

Eligibility criteria: Inclusion Criteria:

1. Children who have clinical symptoms and are suspected of having malignant tumors after being evaluated by clinical pediatricians and require 18F-FDG PET/MR examination to further clarify their conditions.
2. Signed and dated informed consent form
3. Commit to complying with the research procedures and cooperate in the implementation of the entire research process.
4. No gender restriction, aged between 0 and 18 years old.

Exclusion Criteria:

1. Patients with serious illnesses that researchers consider unsuitable for participation in this clinical study. Such as severe heart and lung failure, severe bone marrow suppression, severe liver and kidney dysfunction, etc.
2. Patients with severe claustrophobia，epileptic seizures, respiratory distress who cannot lie down, and patients with mental anomalies who are unable to cooperate.
3. Patients with metal implants such as pacemakers, artificial metal heart valves, and neurostimulators in their bodies.
4. Non-compliant person.

Primary outcomes:
measure: Lesion detection rate
timeFrame: 1 year
measure: Completion of PET/MR examinations
timeFrame: 1 year
measure: Sedation during PET/MR examinations
timeFrame: 1 year
measure: Qualitative image quality
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: China, Shanghai Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine
state: Shanghai
Study officials:
References: