louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03277534: Electrical Stimulation Combined With Motor Training on EEG-EMG Coherence and Motor Function in Individuals With Stroke
Official title: Effects of 8-week Sensory Electrical Stimulation Combined With Motor Training on EEG-EMG Coherence and Motor Function in Individuals With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: electrical stimulation
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2017-09-11
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study investigated whether electrical stimulation (ES) prior to a hand function training session for a total of eight weeks can better improve neuromuscular control and hand function in subacute stroke individuals and change electroencephalography-electromyography (EEG-EMG) coherence, as compared to the control (sham ES).

Detailed description: Subjects were randomly assigned into ES and control groups. Both groups received 20-minute hand function training twice a week, and the ES group received 40-minute ES on the median nerve of the affected side before each training session. The control group received sham ES - electrodes were placed on the same location but no electric current was applied. EEG, EMG and Fugl-Meyer Assessment (FMA) were collected before, at the 4th week, at the end of 8th week, and 4 weeks after the end of intervention.

Eligibility criteria: Inclusion Criteria:

1. first-ever cerebral cortical region involved chronic stroke, onset over a month,
2. able to perform active thumb flexion on the affected side with the scores of manual muscle test at least two points, and
3. at stable medical condition for intervention

Exclusion Criteria:

1. history of other neurological disorders,
2. cognitive impairment (Mini-Mental State Examination score \<24, MMSE),26
3. unable to follow orders,
4. contraindications of ES, and
5. under 20 years old

Primary outcomes:
measure: Fugl-Meyer Assessment for Upper Extremity
timeFrame: before intervention, four weeks after, at the end of the eight-week intervention and four weeks after the intervention period ended
measure: EEG-EMG coherence
timeFrame: before intervention, four weeks after, at the end of the eight-week intervention and four weeks after the intervention period ended
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04132934: Observational Study of Effectiveness and Tolerability of Gliclazide MR 60mg in Diabetic Patients Fasting During RAMADAN
Official title: Observational Study Program Assessing Effectiveness and Tolerability of Gliclazide MR 60mg in Patients With Type 2 Diabetes Fasting During RAMADAN
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Lead sponsor: Servier
Sponsor class: INDUSTRY
First posted: 2019-10-21
Enrollment: 1200
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: Patients with type 2 diabetes observing fast during Ramadan

Brief summary: The purpose of this observational study is to assess effectiveness and tolerability of gliclazide MR 60mg during RAMADAN in a real world setting in 9 countries from Asia Pacific and Middle East/North Africa


Eligibility criteria: Inclusion Criteria:

* Informed consent obtained before any trial-related activities
* Male or female type 2 diabetic patients aged \>18 years
* Patients with controlled or suboptimal controlled type 2 diabetes
* Patients with experience in SMBG controlling using glucometer
* Patients who are willing to fast during Ramadan
* Patients already treated with Gliclazide MR 60mg

Exclusion Criteria:

* Insulin therapy requirement
* Severe liver or renal failure
* HbA1c ≥ 9%
* Contraindication to gliclazide according to SmPC
* Pregnancy or breast feeding
* Previous experience of severe or repeated hypoglycemia events without triggered factor within the previous year

Primary outcomes:
measure: Proportion of patients with at least one Hypoglycemia event
timeFrame: up to 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Servier Affaires Medicales
Study officials:
References:
citation: Hassanein M, Al Sifri S, Shaikh S, Abbas Raza S, Akram J, Pranoto A, Rudijanto A, Shaltout I, Fariduddin M, Mohd Izani Wan Mohamed W, Al Awadi F, Alessa T; DIA-RAMADAN study investigators. A real-world study in patients with type 2 diabetes mellitus treated with gliclazide modified-release during fasting: DIA-RAMADAN. Diabetes Res Clin Pract. 2020 May;163:108154. doi: 10.1016/j.diabres.2020.108154. Epub 2020 Apr 21.
citation: Hassanein M, Al Sifri S, Shaikh S, Raza SA, Akram J, Rudijanto A, Shaltout I, Fariduddin M, Mohamed WMIBW, Al Awadi F, Durocher A, Cortese V, Alessa T. Descriptive Regional Subanalysis of a Real-World Study in Patients with Type 2 Diabetes Treated with Gliclazide MR During Fasting: DIA-RAMADAN. Diabetes Ther. 2021 Jun;12(6):1703-1719. doi: 10.1007/s13300-021-01067-1. Epub 2021 May 11.
Clinical trial NCT01759134: Comparison of Post-Discharge Growth of Premature Infants Using Two Different Formulas
Official title: Comparison of Post-Discharge Growth of Premature Infants Using Two Different Formulas
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Premature Birth of Newborn
Keywords: Premature neonate
Post-discharge
Formula
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2013-01-02
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study is to compare the post-discharge growth of preterm infants fed with 2 different post discharge formulas.

Detailed description: Infants will be randomized upon discharge from the NICU. We will follow weight, height and head circumference for three months following discharge, In addition any feeding difficulties will be noted.

Eligibility criteria: Inclusion Criteria:

1. Preterm infants that are being fed only by formulas (mother chose not to breast feed, or cannot breast feed).
2. Gestational week 30-34.

Exclusion Criteria:

1. Congenital major malformation (e.g. congenital heart disease).
2. Chromosomal abnormality (e.g. Down's syndrome)
3. Gastrointestinal morbidity: S/P abdominal surgery, S/P NEC
4. Milk allergy
5. Chronic disease (e.g. oxygen treatment)

Primary outcomes:
measure: growth
timeFrame: 3 months post discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
affiliation: Shaare Zedek Medical Center
name: Alona Bin-Nun, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shaare Zedek Medical Center
name: Cathy Hammerman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03947034: Monitoring the Hyperammonaemia:TOXicity of Drugs (AmmoTOX)
Official title: Monitoring the Hyperammonaemia:TOXicity of Drugs (AmmoTOX)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperammonemia
Metabolic Disease
Adverse Drug Event
Drug Toxicity
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
First posted: 2019-05-13
Enrollment: 2700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with a drug that could be reported in the WHO's pharmacovigilance database

Brief summary: Several drugs and chemotherapies seem to have an impact on the metabolic system. This study investigates reports of metabolic toxicities such as hyperammonemia, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

Detailed description: Several drugs and chemotherapies seem to have an impact on the metabolic system and are responsible of a wide range of metabolical side effects such as hyperammonemia. Those are poorly described, due to the modification of the pharmacopeia, and the recent recognition of several of these adverse events. This study investigates the main characteristics of patients affected by metabolic side effects imputed to drugs in particular hyperammonemia. A causality assessment according to the WHO-UMC (World Health Organization - Uppsala Monitoring Center) is systematically applied.

Eligibility criteria: Inclusion Criteria:

* Case reported in the WHO's pharmacovigilance database till 01/05/2019

Exclusion Criteria:

* Chronology not compatible between the drug and the toxicity

Primary outcomes:
measure: Metabolic toxicities (such as hyperammnemia) of drugs Identification and report of cases of metabolic toxicities associated with drugs.
timeFrame: to 01/05/2019
Secondary outcomes:
measure: Causality assessment of reported metabolic toxicities events according to the WHO system
timeFrame: to 01/05/2019
measure: Description of the type of metabolic toxicity depending on the category of drug
timeFrame: to 01/05/2019
measure: Description of the other immune related adverse events concomitant to the metabolic toxicity induced by drugs
timeFrame: to 01/05/2019
measure: Description of the duration of treatment when the toxicity happens (role of cumulative dose)
timeFrame: to 01/05/2019
measure: Description of the drug-drug interactions associated with adverse events
timeFrame: to 01/05/2019
measure: Description of the pathologies (cancer) for which the incriminated drugs have been prescribed
timeFrame: to 01/05/2019
measure: Description of the population of patients having hematological toxicity adverse event
timeFrame: to 01/05/2019
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM
Study officials:
References:
Clinical trial NCT00356434: A Comparison of Sequential Compression Devices and Foot Pumps in the Obstetric Population
Official title: Study of Patient Compliance and Comfort Using Sequential Compression Devices and Foot Pumps for DVT Prevention
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Thrombophilia
Keywords: deep vein thrombosis
thrombophilia
pregnancy
thromboprophylaxis
decreased mobility
hospitalization
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2006-07-26
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The researchers at Johns Hopkins University believe that the foot pump will be superior to sequential compression devices in comfort and patient compliance which may increase provider efforts to prevent deep vein thrombosis (DVT) in pregnancy.

Detailed description: The investigators will be comparing sequential compression devices (SCDs) to foot pumps to determine if foot pumps will be better tolerated by obstetric patients, both antepartum and intrapartum. Patients in whom thromboembolic prophylaxis is deemed necessary and ordered by the treating physician, who agree to participate in the study will be randomly assigned to receive SCDs or the foot pump as part of their thromboembolic prophylaxis regimen. The investigators will administer a questionnaire to assess patients' satisfaction and comfort with each device and they will be asked to complete a log of hours they wore their assigned device for a 7 day period (or as long as they are prescribed). Random spot checks to verify compliance will be performed.

Eligibility criteria: Inclusion Criteria:

* Pregnant
* Bedrest
* Thrombophilia
* Prescribed DVT prophylaxis

Exclusion Criteria:

* Active DVT

Primary outcomes:
measure: Comfort Level
timeFrame: once during first 7 days of hospitalization
measure: Patient Compliance
timeFrame: for 1-7 days during hospitalization
Secondary outcomes:
measure: DVT Prevention
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Abimbola Aina, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Middleton P, Shepherd E, Gomersall JC. Venous thromboembolism prophylaxis for women at risk during pregnancy and the early postnatal period. Cochrane Database Syst Rev. 2021 Mar 29;3(3):CD001689. doi: 10.1002/14651858.CD001689.pub4.
Clinical trial NCT00503334: Preoperative Oral Nutritional Supplement (preOP Booster) in Visceral Surgery
Official title: Efficacy and Tolerability of a Preoperative Oral Nutritional Supplement (preOP Booster) Versus Placebo in Visceral Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enteral Nutrition (Food for Special Medical Purposes)
Lead sponsor: Fresenius Kabi
Sponsor class: INDUSTRY
First posted: 2007-07-18
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this pilot study is to investigate the effect of an oral nutritional supplement (preOP booster) versus placebo regarding metabolic criteria in patients undergoing elective pancreaticoduodenectomy.


Eligibility criteria: Inclusion Criteria:

* Elective pancreaticoduodenectomy

Exclusion Criteria:

* Concomitant chemotherapy
* Severe malnutrition (SGA score C)
* Conditions affecting gastric emptying

Primary outcomes:
measure: laboratory measurements: total endogenous antioxidant capacity, free radicals, CRP;
timeFrame: up to 30 days after surgery
Secondary outcomes:
measure: postoperative complications, pre- and postoperative discomfort (well-being), muscle strength at 7 days post-op, length of stay (hospital / ICU), ambulation time, gastro intestinal tolerance
timeFrame: up to 30 days after surgery
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Università Salute-Vita San Raffaele,
Study officials:
affiliation: Università Salute-Vita San Raffaele, Milan, Italy
name: Marco Braga, Prof MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01092234: Effectiveness of an Observational Unit at St. Olavs Hospital
Official title: An Open Randomized Trial of the Effectiveness of an Observational Unit at St. Olavs Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emergency Patients
Keywords: Observational units
Length of stay (LOS)
Readmission
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
First posted: 2010-03-24
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The trial is designed to evaluate the effectiveness of a newly established Observational unit at St. Olavs Hospital in terms of readmission rates, compared to the provision of care in normal/traditional units for defined diagnosis and medical problems.

Detailed description: Observational units are thought to be more efficient than traditional ward units, but the evidence is scarce. The trial will in a randomized fashion evaluate the study hypothesis at an organizational level and not confined to specific diagnosis. The hypothesis to be tested is to confirm or reject the equal effectiveness of an Observational unit compared to a traditional ward for organizing in-hospital care.There are established eligibility and exclusion criteria based on clinical experience. Endpoint is length of stay and readmission within 30 days. In addition the study will give information on the use of diagnostic and treatment resources used and collect some basic demographic variables.

Eligibility criteria: Inclusion Criteria:

* Emergency admitted patients only
* All patients on the list (appendix 1) with a tentative length of stay \< 24 hours
* Predicted stay of less than 24 hours
* Willingness and able to sign a informed consent

Exclusion Criteria:

* Emergency admitted patients with life threatening illnesses
* Patients with a tentative length of stay \> 24 hours based on the summary of medical and logistical considerations e.g. need of major - surgery, infections with prolonged infusions of antibiotics.
* Unwillingness to sign a informed consent
* By discretion of the physician/surgeon
* Readmission of any reason in the study period (within 30 days)

Primary outcomes:
measure: Length of stay (LOS)
timeFrame: 1 year
Secondary outcomes:
measure: Readmission within 30 days
timeFrame: 30 days
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Erik Rødevand, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Olavs Hospital
name: Siv Mørkved, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT00500734: Cardiomyopathy Tissue Bank in a Cancer Population
Official title: Cardiomyopathy Tissue Bank in a Cancer Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Disease
Keywords: Cardiomyopathy
Tissue Bank
Heart Disease
Heart Failure
Congestive Heart Failure
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2007-07-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with heart disease and that may be at a high risk for the development of heart failure.

Brief summary: Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant.

The goal of this laboratory research study is to collect and store blood and tissue from patients who have a diagnosis of heart disease and may be at a high risk for the development of heart failure. This blood may be used in the future to identify genes that may play a role in developing congestive heart failure (CHF) from chemotherapy or other sources.

This is an investigational study. All will be enrolled at MD Anderson.

Detailed description: You will have a one time blood draw of 2 teaspoons of blood for use in future research. This blood may be studied in the future to try to find possible genetic or biochemical markers that may be the cause of CHF. Your blood will be drawn either on an outpatient basis or during a routine visit to the hospital. If you already have a central line or an IV placed, the blood will be drawn at these sites to decrease the pain and discomfort of the blood draw. The information obtained in this study will not be put into your medical records.

Eligibility criteria: Inclusion Criteria:

* Patients who are at high risk for developing Cardiomyopathy or Congestive Heart Failure.
* Patients two months of age and older.

Exclusion Criteria:

* Those that are not willing to sign an informed consent.

Primary outcomes:
measure: Baseline Patient Demographic Information (age, sex, race)
timeFrame: One time visit.
measure: Identification biological markers predisposing cancer patients to development of chemotherapy-induced congestive heart failure
timeFrame: One time visit for collection of blood and tissue samples.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jean-Bernard Durand, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06807034: Impact of the Oral Microbiota on Relapse in HNSCC Patients
Official title: Impact of the Oral Microbiota on Relapse in HNSCC Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Head and Neck Cancer
Lead sponsor: Institut Sainte Catherine
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 100
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: to characterise the impact of microbiota in radiotherapy efficacy


Eligibility criteria: Inclusion Criteria:

* head and neck cancer

Exclusion Criteria:

-

Primary outcomes:
measure: Microbiota
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Avignon
country: France
facility: ICAP
Study officials:
References:
Clinical trial NCT04564534: Impact of Pre-procedure Cognitive Status on Outcome at 3 Months After Transcatheter Aortic Valve Implantation
Official title: Impact of Pre-procedure Cognitive Status on Outcome at 3 Months After Transcatheter Aortic Valve Implantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Stenosis
Keywords: transcatheter aortic valve replacement
aortic stenosis
cognitive status
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 109
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: Patients with aortic stenosis and a confirmed indication for TAVI, scheduled to undergo TAVI and who perform their pre-TAVI work-up in our centre will be invited to participate.

Brief summary: This study plans to investigate the relationship between cognitive status pre-procedure, and clinical outcomes at 3 months in patients undergoing transcatheter aortic valve implantation (TAVI).

Detailed description: This study plans to investigate the relationship between cognitive status pre-procedure, as assessed using the Montreal Cognitive Assessment (MoCA) administered on a tablet, and clinical outcomes at 3 months as assessed by the VARC2 criteria, in patients undergoing transcatheter aortic valve implantation (TAVI)

Eligibility criteria: Inclusion Criteria:

* Aged 18 years or over
* Scheduled to undergo TAVI
* Provide informed consent
* Able to understand French

Exclusion Criteria:

* subjects under legal guardianship or other legal protection
* subjects with documented severe dementia
* subjects with anticipated poor compliance
* subjects unable to understand French sufficiently well to perform the MoCA test
* pregnant women
* subjects within the exclusion period of another study

Primary outcomes:
measure: All-cause death
timeFrame: through 30 days after the TAVI procedure
measure: Stroke
timeFrame: through 30 days after the TAVI procedure
measure: life-threatening bleed
timeFrame: through 30 days after the TAVI procedure
measure: Combined VARC2 safety outcome
timeFrame: through 30 days after the TAVI procedure
measure: Combined VARC2 efficacy outcome
timeFrame: through 30 days after the TAVI procedure
Secondary outcomes:
measure: Time required for MoCA
timeFrame: At the time of MoCA completion
measure: Biological parameters pre-procedure
timeFrame: pre-procedure
measure: Relationship between MoCA score and each component of the VARC2
timeFrame: At 3 months after TAVI procedure
Other outcomes:
Locations:
city: Besancon
country: France
facility: University Hospital Jean Minjoz
Study officials:
affiliation: CHRU Besancon
name: Francois Schiele, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: