louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04725344: Relevance of the Activ'Dos App for Chronic Low Back Pain Patients
Official title: Relevance of the Activ'Dos App for Chronic Low Back Pain Patients - Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Disease
Lumbago
Keywords: Exercise
Self-rehabilitation
Chronic low back pain
Mobile app
mHealth
eHealth
Physiotherapy
Disability
Pain
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are 2 groups : an interventional group with ACTIV'DOS app ; and a control group with a standard procedure using a sheet of paper.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to compare a self rehabilitation program using ACTIV'DOS app versus using a standard sheet of paper.

Detailed description: This study involves patients with chronic low back pain. The purpose of this study is to compare a self-rehabilitation program using ACTIV'DOS app versus a standard sheet of paper. Disabilities are measured with a Roland-Morris questionnaire.

Eligibility criteria: Inclusion Criteria:

* chronic low back pain for more than 3 months
* Aged to 18 or more
* Possibility to use Activ'dos application with smartphone or tablet
* Initial score of Roland Morris questionnaire \>= 4
* Fit to consent
* Who has signed consent form

Exclusion Criteria:

* Any signs of severe illness underlying to radicular and lumbar pain like red flags
* Guardianship or protection of vulnerable adult
* Pregnant or nursing
* Refuse to participate

Primary outcomes:
measure: Change from functional impairment with Roland-Morris questionnaire at 6 weeks.
timeFrame: Day 0 (patient inclusion) and Day 42 (end of patient monitoring)
Secondary outcomes:
measure: Difference of average pain during the seven last days with VAS pain
timeFrame: Day 0 (patient inclusion) and Day 42 (end of patient monitoring)
measure: Difference of worse pain during the seven last days with VAS pain
timeFrame: Day 0 (patient inclusion) and Day 42 (end of patient monitoring)
measure: Compliance (number of sessions done over the number of recommanded sessions) of self-rehabilitation program at 6 weeks
timeFrame: Day 42 (end of patient monitoring)
measure: Assessment of satisfaction with Likert scale
timeFrame: Day 42 (end of patient monitoring)
Other outcomes:
Locations:
city: Brest
country: France
facility: Cabinet de kinésithérapie Natanaël AUDREN
city: Brest
country: France
facility: Cabinet de kinésithérapie Pierre VAL
city: Brest
country: France
facility: Cabinet de kinésithérapie Pol KEROUANTON
city: Brest
country: France
facility: Cabinet de kinésithérapie Vincent LUCAS
Study officials:
References:
Clinical trial NCT01987544: Effects of Ergometer Training With Telemonitoring in Patients With Chronic Obstructive Pulmonary Disease (COPD) After Exacerbation
Official title: German: Effekte Eines Telemonitorisch überwachten Ergometertrainings Bei Patienten Mit Einer COPD Nach Exazerbation: Eine Prospektiv Randomisierte Studie
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: COPD
telemonitoring
training
ergometer
telemedicine
Lead sponsor: Institut für Pneumologie Hagen Ambrock eV
Sponsor class: INDUSTRY
Collaborators: name: Vitaphone GmbH
First posted: 2013-11-19
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Home ergometer training combined with online monitoring and regular telephone support could prove to be a cost-effective method to improve physical performance and quality of life in COPD patients.

The primary objective of the study is to demonstrate a significantly higher daily workout time in patients that are monitored during home ergometer training with telephone support compared to conventional home ergometer training. Consequently we expect an increased quality of life related to the illness and a decreasing BODE-Index. A post-interventional lower BODE-Index correlates with a reduced risk of hospitalisation and mortality.

Detailed description: Hypothesis: There will be an increased prevalence, morbidity and mortality of COPD during the next decades. On the other hand there is a clear correlation between life expectancy and physical activity in this disease. Telemedicine concepts promise new treatment strategies with favourable impact on the long-term process of COPD.

Eligibility criteria: Inclusion Criteria:

* COPD

Exclusion Criteria:

* tumor diseases
* unstable coronary heart disease
* untreated cardiac valve disease
* incapable of giving consent

Primary outcomes:
measure: Training time
timeFrame: 3 month
Secondary outcomes:
measure: BODE-Index
timeFrame: 3 month
Other outcomes:
measure: CAT (COPD Assessment Test)
timeFrame: 3 month
Locations:
city: Hagen
country: Germany
facility: Helios Klinik Hagen
state: NRW
Study officials:
References:
citation: Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.
Clinical trial NCT01342744: Metformin in Postmenopausal Women With Metabolic Syndrome
Official title: Effects of Metformin on Cardiovascular Risk Factors in Postmenopausal Women With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Metabolic Syndrome
Keywords: Cardiovascular risk factors
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2011-04-27
Enrollment: 40
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effects of metformin on cardiovascular risk factors in postmenopausal women with metabolic syndrome.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women aged 45-60 years with metabolic syndrome according to The American Heart Association and The National Heart, Lung, and Blood Institute

Exclusion Criteria:

* Previous cardiovascular diseases
* Contraindicated to metformin: serum creatinine \>1.4 mg/dL, liver disease, alcoholism, congestive heart failure, chronic hypoxic lung disease, prior history of lactic acidosis
* Previous administration of metformin, other hypoglycemic drugs, lipid-lowering drugs, sex steroids, antiplatelet drugs within 3 months before enrollment
* Fasting blood sugar ≥ 200 mg/dL or HbA1c \>8%
* Serum triglyceride ≥500 mg/dL
* Abnormal EKG

Primary outcomes:
measure: Cardiovascular risk factors
timeFrame: 6 months
Secondary outcomes:
measure: 10-year risk of coronary heart disease
timeFrame: 6 months
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Suchada Indhavivadhana, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03596892: Decitabine+BUCY vs BUCY Conditioning Regimen for MLL+ Acute Leukemia Undergoing Allo-HSCT
Official title: Decitabine+Busulfan+Cyclophosphamide vs Busulfan+Cyclophosphamide Conditioning Regimen for Mixed-lineage-leukemia (MLL)-Rearranged Acute Leukemia Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Allogeneic Hematopoietic Stem Cell Transplantation
Conditions
Mixed-lineage-leukemia (MLL)-Rearranged Acute Leukemia
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Guangzhou First People's Hospital
name: Peking University People's Hospital
name: Zhujiang Hospital
name: Third Affiliated Hospital, Sun Yat-Sen University
First posted: 2018-07-24
Enrollment: 122
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recent studies demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for mixed-lineage-leukemia (MLL)-rearranged acute leukemia. Unfortunately, some patients relapsed after allo-HSCT. In this prospective randomized controlled study, the safety and efficacy of Decitabine + BUCY and BUCY myeloablative conditioning regimens in MLL+ acute leukemia undergoing allo-HSCT are evaluated.

Detailed description: Recent studies demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for mixed-lineage-leukemia (MLL)-rearranged acute leukemia. BUCY conditioning regimen is the standard myeloablative regimen for MLL+ acute leukemia undergoing allo-HSCT. However, it appears to have higher relapse rate and lower survival. To reduce the relapse rate and improve the survival, decitabine is added in the conditioning regimen. In this prospective randomized controlled study, the safety and efficacy of Decitabine + BUCY and BUCY myeloablative conditioning regimens in MLL+ acute leukemia undergoing allo-HSCT are evaluated.

Eligibility criteria: Inclusion Criteria:

* MLL+ acute leukemia undergoing allo-HSCT
* 14-65 years

Exclusion Criteria:

* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (investigators' decision)

Primary outcomes:
measure: relapse rate
timeFrame: 2 year
Secondary outcomes:
measure: overall survival (OS)
timeFrame: 2 year
measure: disease-free survival (DFS)
timeFrame: 2 year
measure: transplant-related mortality (TRM)
timeFrame: 2 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Hematology,Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Qifa Liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02988492: Acute Stroke Thrombectomy: Does CT Perfusion Accurately Predict Infarct on MRI After Recanalization
Official title: Acute Stroke Thrombectomy: Does CT Perfusion Accurately Predict Infarct on MRI After Recanalization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2016-12-09
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: DIAGNOSTIC

Brief summary: The newest generation of stent---retrievers results in higher recanalization rates and faster recanalization time compared to older generation endovascular therapies for acute stroke. Advanced neuroimaging can potentially improve the assessment of infarct core and inform decision---making in patients being considered for endovascular therapy. Evaluation of infarct core may be performed with NECT, CTASI or CT perfusion. In the past, evaluation of CTP in predicting core infarct in acute stroke has been limited because recanalization status was lacking. In addition, final infarct size may be underestimated on NECT compared with MRI. These two limitations can now be addressed: the new generation of stent---retrievers allows accurate determination recanalization time; evaluating the test characteristics of CTP using 24 hour DWI---MRI as the reference standard can be readily performed.

We aim to prospectively investigate the sensitivity and specificity of whole---brain CTP in predicting 24 hour DWI---MRI infarct in patients with acute proximal anterior circulation occlusions successfully recanalized with endovascular treatment.


Eligibility criteria: Inclusion Criteria:

1. Admission NECT, CTA neck and COW or multi-phase CTA or CTP. Follow---up 24 hr DWI---MRI performed
2. Endovascular therapy performed for acute anterior circulation stroke as per clinical practice.
3. Patient with an angiographically documented ICA, M1 or M2 occlusion

Exclusion Criteria:

None

Primary outcomes:
measure: Evaluate the sensitivity and specificity of CTP
timeFrame: Up to 24 months
Secondary outcomes:
measure: Correlate advanced imaging to clinical outcome
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Daniela Iancu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02446392: The Distribution of Plasma Drug Concentrations of Beta-lactam Antibiotics in Intensive Care Unit Patients
Official title: The Distribution of Plasma Drug Concentrations of Beta-lactam Antibiotics in Intensive Care Unit Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2015-05-18
Enrollment: 120
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: Intensive care unit patients treated with beta-lactam antibiotics

Brief summary: In this project, intensive care unit (ICU) patients treated with beta-lactam antibiotics are included with the aim to investigate the potential underdosing in this patient group. Four regional ICU-clinics are recruiting consecutive patients (n=120) and samples are taken before the next dose is administered for three consecutive days.


Eligibility criteria: Inclusion Criteria:

* Current treatment with beta-lactam antibiotics and admission to the ICU

Exclusion Criteria:

* Pregnancy, age below 18 years

Primary outcomes:
measure: The rate of patients below 16mg/L for piperacillin-tazobactam, 2 mg/L for meropenem and 4mg/L for cefotaxim
timeFrame: 3 days
Secondary outcomes:
measure: Mortality in relation to initial levels of beta-lactam antibiotics as defined in primary outcome
timeFrame: 30 days
measure: The rate of patients below 100% time over MIC in relation to the bacteria causing the infection.
timeFrame: 3 days
measure: Kidney function measured as eGFR in relation to initial levels of beta-lactam antibiotics as defined in primary outcome
timeFrame: 3 days
measure: SAPS-score in relation to initial levels of beta-lactam antibiotics as defined in primary outcome
timeFrame: 3 days
measure: Days in intensive care unit in relation to initial levels of beta-lactam antibiotics as defined in primary outcome
timeFrame: 30 days
Other outcomes:
Locations:
city: Jönköping
country: Sweden
facility: Intensive care unit
city: Kalmar
country: Sweden
facility: Intensive Care Unit
city: Linköping
country: Sweden
facility: Intensive Care Unit
city: Växjö
country: Sweden
facility: Intensive care unit
Study officials:
affiliation: Linkoeping University
name: Thomas Schön, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Udy AA, Roberts JA, Lipman J. Clinical implications of antibiotic pharmacokinetic principles in the critically ill. Intensive Care Med. 2013 Dec;39(12):2070-82. doi: 10.1007/s00134-013-3088-4. Epub 2013 Sep 18.
Clinical trial NCT03713892: CKD-504 in SAD and MAD in Healthy Korean and Caucasian Adult Male and Female Subjects
Official title: Phase I Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, PK, PD of CKD-504 in Single SAD and MAD in Healthy Korean and Caucasian Adult Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Huntington Disease
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2018-10-22
Enrollment: 88
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending oral doses of CKD-504 compared to placebo in healthy Korean and Caucasian adult subjects


Eligibility criteria: Inclusion Criteria:

* Healthy adult Korean or Caucasian aged 19 to 45 (inclusive) years, at the time of screening.
* Subjects weighing ≥ 50 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit.
* Subjects who agreed to voluntarily participate in this study and comply with all the protocol requirements by signing informed consent form after being informed of the nature of this study and understanding all aspects of this study.
* Subjects who were deemed as eligible subjects by investigators on their physical examination, laboratory findings, and medical examination by interview.

Exclusion Criteria:

* Subjects with a history of hypersensitivities to the drug, including investigational drugs or other drugs or with a history of clinically significant hypersensitivities.
* Subjects with a history of drug abuse or a positive urine screening for drug abuse.
* Subjects who have participated and taken investigational drug in any other clinical trial (including bioequivalence study) within three months prior to study drug administration.
* Subjects who have donated a unit of whole blood within 60 days or blood components within 30 days prior to study drug administration.
* Subjects judged ineligible for the study after a review of the clinical laboratory results by the investigator or for other reasons.

Primary outcomes:
measure: Cmax of CKD-504
timeFrame: Day1, Day2, Day3, Day4
measure: AUC of CKD-504
timeFrame: Day1, Day2, Day3, Day4
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Kyung-Sang Yu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01865292: Comparing the Pharmacodynamics and Pharmacokinetics of Explorative Formulation of Insulin Degludec With Insulin Glargine in Subjects With Type 1 and Type 2 Diabetes
Official title: A Randomised, Double-Blind, Single Dose, Six-Period Cross-over Dose Response Trial Comparing the Pharmacodynamics and Pharmacokinetics of Insulin 454 With Insulin Glargine in Subjects With Type 1 and Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-05-30
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics (the effect of the investigated drug on the body) and pharmacokinetics (the exposure of the trial drug in the body) of insulin degludec (insulin 454), an explorative formulation, not similar to the proposed commercial formulation, with insulin glargine in subjects with type 1 and type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Glycosylated haemoglobin (HbA1c) below or equal to 10 procent based on central laboratory results
* Specific inclusion criteria for subject with type 1 diabetes:
* Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months prior to screening
* Body Mass Index (BMI) between 18.0 and 27.0 kg/m\^2 (both inclusive)
* Specific inclusion criteria for subject with type 2 diabetes:
* Diagnosed with type 2 diabetes mellitus for at least 12 months prior to screening
* Treated with insulin for the past 3 months prior to screening
* Body Mass Index (BMI) between 22.0 and 35.0 kg/ m\^2 (both inclusive)

Exclusion Criteria:

* Subject with a history of significant multiple drug allergies or with a known allergy or suspected allergy to the trial product or any medicine chemically related to the trial product,as judged by the Investigator.
* Subject with a history of or presence of cancer
* Any condition that the Investigator and/or Sponsor feels would interfere with study
* Specific exclusion criteria for subject with type 2 diabetes:
* Therapy with oral antidiabetic drugs within the past 3 months prior to screening

Primary outcomes:
measure: Area under the glucose infusion rate curve
timeFrame: 0-24 hours after dosing
Secondary outcomes:
measure: Area under the insulin degludec/insulin glargine curve
timeFrame: 0-96 hours after dosing
Other outcomes:
Locations:
city: Neuss
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01395992: Long-Term Safety Extension Trial of Asenapine in Bipolar 1 Disorder Participants Who Completed Protocol P05691 (P05692)
Official title: A Multicenter, Double-Blind, Fixed-Dose, Long-Term Extension Trial of the Safety of Asenapine in Subjects Diagnosed With Bipolar 1 Disorder Who Completed Protocol P05691 (Formerly 041044) (Phase3B, Protocol P05692 [Formerly 041045])
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar I Disorder
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2011-07-18
Enrollment: 165
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: Participants who have completed the 3-week trial P05691 (NCT00764478) can be screened for eligibility for this 26-week extension study in which they will continue treatment. The primary purpose of this trial is to evaluate the long-term safety of asenapine.


Eligibility criteria: Inclusion criteria:

* Each participant must have completed the short-term trial P05691, and be judged by the investigator to likely benefit from continued treatment
* Each participant must have demonstrated an acceptable degree of compliance with trial medication, visits, and other requirements in the short-term trial P05691

Exclusion criteria:

* A participant must not have had any adverse event or other clinically significant finding(s) in the short-term trial P05691 that would prohibit the subject's continuation into this long-term extension trial
* A participant must not have any newly diagnosed or discovered psychiatric condition that would have excluded the subject from participation in the short-term trial P05691
* A participant must not be at imminent risk of self-harm or harm to others

Primary outcomes:
measure: Number of participants experiencing clinical and laboratory adverse events (AEs)
timeFrame: Baseline up to 212 days
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Forest Investigative Site 1000
state: Texas
Study officials:
References: