louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04576013: Peripheral Nerve Stimulation to Improve Upper Extremity Function After Severe Stroke
Official title: Peripheral Nerve Stimulation to Improve Upper Extremity Function After Severe Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Keywords: neuroplasticity
rehabilitation
peripheral nerve stimulation
motor training
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 12
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: Subjects will receive non-invasive stimulation of nerves on their arm and intensive motor training of their arm. The timing of the stimulation in relation to the training will vary by group.

Detailed description: This study will look at the differences in improvement of hand and arm function when nerve stimulation is applied at different times in relation to motor training. The nerve stimulation, called peripheral nerve stimulation (PNS), is non-invasive and painless. Subjects in the study may receive strong or mild PNS. Subjects will also vary by whether PNS is delivered for 2 hours before the 2 hours of motor training, or during the 2 hours of motor training. Which level of stimulation and its timing will be determined randomly for each subject.

Eligibility criteria: Inclusion Criteria:

* Have severe upper extremity motor deficit after a single stroke
* Stroke onset at least 12 months ago

Exclusion Criteria:

* Addition or change in the dosage of drugs known to exert detrimental effects on motor recovery within 3 months of enrollment
* Untreated depression
* History of multiple strokes
* History of seizure
* History of head injury with loss of consciousness, severe alcohol or drug abuse, or psychiatric illness
* Positive pregnancy test or being of childbearing age and not using appropriate contraception
* Presence of ferromagnetic material in the cranium except in the mouth, including metal fragments from occupational exposure, and surgical clips in or near the brain
* Cardiac or neural pacemakers or implanted medication pumps
* Receptive aphasia

Primary outcomes:
measure: Fugl-Meyer Assessment
timeFrame: Baseline, Immediately post-intervention
Secondary outcomes:
measure: Action Research Arm Test
timeFrame: Baseline, Immediately post-intervention
measure: Stroke Impact Scale
timeFrame: Baseline, Immediately post-intervention
measure: Cortical motor map volume
timeFrame: Baseline, Immediately post-intervention
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky at Cardinal Hill Rehabilitation Hospital
state: Kentucky
Study officials:
References:
Clinical trial NCT04018313: To Compare the PK and Safety of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects
Official title: A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Three Formulations of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2019-07-12
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Three Formulations of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects


Eligibility criteria: Inclusion Criteria:

* Healthy subject (male or female) between the ages of 18 and 55 years.
* Subject with a body weight of \> 40 kg and ≤ 90 kg and a BMI between 18.0 kg/m2 and 32.0 kg/m2(both inclusive).
* Subject with a total IgE level of ≤ 100 IU/mL.

Exclusion Criteria:

* Subject has a medical history and/or current presence of disease including one or more of the allergic reaction.

Primary outcomes:
measure: Pharmacokinetic Outcome Measures [AUC0-inf] for Part 2
timeFrame: up to day 127
measure: Pharmacokinetic Outcome Measures [AUC0-last] for Part 2
timeFrame: up to day 127
measure: Pharmacokinetic Outcome Measures [Cmax] for Part 2
timeFrame: up to day 127
Secondary outcomes:
measure: Pharmacokinetic Outcome Measures [Tmax] for Part 1& Part 2
timeFrame: up to day 127
measure: Pharmacokinetic Outcome Measures [t1/2] for Part 1& Part 2
timeFrame: up to day 127
measure: Pharmacodynamics Outcome Measures [Cmin of Free IgE] for Part 1 & Part 2
timeFrame: up to day 127
measure: Pharmacodynamic Outcome Measures [Tmin of Free IgE] for Part 1 & Part 2
timeFrame: Up to day 127
measure: Pharmacodynamic Outcome Measures [Cmax of Total IgE] for Part 1 & Part 2
timeFrame: up to day 127
measure: Pharmacodynamic Outcome Measures [Tmax of Total IgE] for Part 1 & Part 2
timeFrame: up to day 127
Other outcomes:
Locations:
city: Herston
country: Australia
facility: Phase 1 unit
state: Queensland
city: Adelaide
country: Australia
facility: Phase 1 unit
state: South Australia
Study officials:
affiliation: Celltrion
name: SungHyun Kim
role: STUDY_DIRECTOR
References:
Clinical trial NCT06561113: The Effect of Turkish Coffee on Postural Control and Hand-eye Coordination in Young Adults
Official title: Does a Cup of Turkish Coffee Affect Postural Control and Hand-eye Coordination in Young Adults? A Quasi-experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caffeine
Balance; Distorted
Coordination and Balance Disturbances
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Although the effects of different doses of caffeine on balance have been evaluated in various studies, the effects of low doses of caffeine ingested with Turkish coffee on postural control and hand-eye coordination remain unclear. In this study, it will be investigated the acute effects of 60 mg caffeine intake via Turkish coffee on postural control and hand-eye coordination.

Detailed description: This study is designed as a one-group pretest-posttest quasi-experimental research. The study will be conducted with healthy young adults with low coffee consumption habits. Participants who meet the inclusion and exclusion criteria will undergo postural control assessment with the Biodex Balance System® and hand-eye coordination test with the Alternate Hand Wall Toss Test. Subjects will be given 65 ml of Turkish coffee (one cup) to ensure oral caffeine intake. The same assessments will be repeated 30 minutes after caffeine intake.

Eligibility criteria: Inclusion Criteria:

* Being 18-26 years of age
* Having a normal body mass index

Exclusion Criteria:

* Having a health problem that prevented caffeine intake
* Having a diagnosis of vestibular and neurological disease
* Using drugs that affect the central nervous system
* Using any medication related to chronic disease
* Having lower extremity rotational alignment disorder
* Having a history of lower and/or upper extremity injury or surgery in the last year

Primary outcomes:
measure: Postural control assessment with Biodex Balance System
timeFrame: Baseline and immediately after caffeine intake
Secondary outcomes:
measure: Hand-eye coordination assessment with alternate hand-wall toss test
timeFrame: Baseline and immediately after caffeine intake
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
References:
Clinical trial NCT01729013: Duration of Vitamin D Stores After Prolonged Vitamin D Substitution
Official title: Duration of Vitamin D Stores After Prolonged Vitamin D Substitution
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: vitamin D
fat
biopsy
Lead sponsor: University of Tromso
Sponsor class: OTHER
First posted: 2012-11-20
Enrollment: 78
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have previously participated in a vitamin D study

Brief summary: Ingested or skin produced vitamin D is either hydroxylated in the liver to 25-hydroxyvitamin D (25(OH)D), metabolized and excreted in the urine, or stored in adipose and other tissues. The capacity for vitamin D storage in adipose tissue is not known, nor the importance of such storage which may potentially be of vital importance when intake or solar exposure is limited. In the present study we will include 76 subjects who have participated in an intervention study with vitamin D (20.000 IU per week) versus placebo for the prevention of type 2 diabetes, and who have completed the study after 5 years or who have been excluded because of diagnosed type 2 diabetes or for other reasons. If vitamin D is stored to any extent in the body the subjects given 20.000 IU vitamin D per week for 2-5 years will have a considerable amount of stored vitamin D and accordingly, a slow decline in serum 25(OH)D during the following year without vitamin D substitution, which will be measured in the present study. If our hypothesis is correct, that vitamin D can be stored in significant amounts when the supply is abundant; current advice on vitamin D supplementation mainly during winter should be changed to "year around" in order to build up sufficient stores for the months without sufficient sun light.


Eligibility criteria: Inclusion Criteria:

* previously participated in a vitamin D study

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: half-life of serum 25-hydroxyvitamin D
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University of Tromsø
Study officials:
affiliation: University of Tromso
name: rolf jorde, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martinaityte I, Kamycheva E, Didriksen A, Jakobsen J, Jorde R. Vitamin D Stored in Fat Tissue During a 5-Year Intervention Affects Serum 25-Hydroxyvitamin D Levels the Following Year. J Clin Endocrinol Metab. 2017 Oct 1;102(10):3731-3738. doi: 10.1210/jc.2017-01187.
Clinical trial NCT00018213: Naltrexone and Patch for Smokers
Official title: Naltrexone and Nicotine Replacement Effects on Cue Reactivity of Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: Naltrexone
Nicotine patch
Tobacco dependence
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effects of naltrexone, alone and combined with nicotine patch, on responses of smokers to smoking cues after 10 hours of tobacco deprivation. Smokers who are not seeking treatment will be assigned to one of six conditions: They will receive either 50 mg of naltrexone or a placebo pill, and also will wear a nicotine patch that has 0, 21, or 42 mg of nicotine during the tobacco deprivation period. Both the day before the medication and deprivation and at the end of 10 hours of deprivation all will be exposed to lit cigarette cues in the laboratory. Effects of the medications will be assessed on withdrawal measures, urge to smoke, psychophysiological measures, and the topography of smoking three test cigarettes. Studies such as these can help to identify potential interventions for tobacco cessation or withdrawal, and thereby could result in less suffering and mortality.


Eligibility criteria: Adults who have smoked at least 25 cigarettes per day for at least a year. They are not using any method to quit smoking and are not using naltrexone. Must weigh at least 100lbs with no medical contraindications for naltrexone or transdermal nicotine. No contraindicated medications, no recent opiate use or history

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: VA Medical Center
state: Rhode Island
Study officials:
References:
Clinical trial NCT04524013: Swiss National Iodine Survey 2020
Official title: Swiss National Iodine Survey 2020
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: Department of Epidemiology and Health Services, Unisanté, Lausanne
name: University Children's Hospital, Zurich
First posted: 2020-08-24
Enrollment: 875
Sex: ALL
Minimum age (years): 6
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Both groups: nationally representative sample selected through schools (children) and gynecologists (women).

School aged children: aged between 6 and 12 years Pregnant women: aged between 18 and 44 years, pregnant

Brief summary: This study will assess iodine status in school aged children and pregnant women is Switzerland. In addition, thyroid status and omega-3 index will be assessed in pregnant women.


Eligibility criteria: Inclusion Criteria:

* Healthy
* for pregnant women: confirmed pregnancy
* living in Switzerland for min 1 year

Exclusion Criteria:

* no history of major medical illness
* no iodine containing contrast agents or medication in the past 6 months

Primary outcomes:
measure: Urinary iodine concentration
timeFrame: Baseline
Secondary outcomes:
measure: Urinary creatinine concentration
timeFrame: Baseline
measure: Urinary sodium concentration
timeFrame: Baseline
measure: Urinary fluoride concentration
timeFrame: Baseline
measure: Thyroid stimulating hormone
timeFrame: Baseline
measure: T3
timeFrame: Baseline
measure: T4
timeFrame: Baseline
measure: Omega 3 index
timeFrame: Baseline
Other outcomes:
measure: Weight
timeFrame: Baseline
measure: Height
timeFrame: Baseline
measure: Omega 3 intake
timeFrame: Baseline
measure: Depressive symptoms
timeFrame: Baseline
Locations:
city: Zurich
country: Switzerland
facility: Human Nutrition Laboratory, ETH Zurich
Study officials:
References:
Clinical trial NCT03009513: Teneligliptin-Glimepiride DDI Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus
Lead sponsor: Handok Inc.
Sponsor class: INDUSTRY
First posted: 2017-01-04
Enrollment: 26
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open label, one sequence study to investigate the pharmacokinetic drug interaction between Teneligliptin and Glimepiride in healthy male subjects


Eligibility criteria: Inclusion Criteria:

1. Healthy male adult aged 20 to 45 years
2. Body weight ≥ 50kg, and BMI between 18 and 29 kg/m2 at screening
3. Subject who agrees to use a medically acceptable double-barrier method of contraception and not to donate sperms from the first dose until 2 months after the last dose.
4. Subject who was given, and fully understood, the information about the study, and has provided voluntary written informed consent to participate in the study and agreed to comply with the study requirements.

Exclusion Criteria:

Primary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: 24hr
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: 24hr
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01718613: Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients
Official title: Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Septic Shock
Lead sponsor: Instituto do Cancer do Estado de São Paulo
Sponsor class: OTHER
First posted: 2012-10-31
Enrollment: 250
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: Although arginine vasopressin has been used as an additional drug in refractory shock in worldwide clinical practice, there are no prospective studies using it as a first choice therapy in patients with cancer and septic shock.

The aim of this study is assess if the use of arginine vasopressin would be more effective on treatment of septic shock in cancer patients than norepinephrine, decreasing the composite end point of mortality and organ failure in 28 days.


Eligibility criteria: Inclusion Criteria:

* Solid neoplasm needing ICU
* Septic Shock according standard criteria

Exclusion Criteria:

* Younger than 18 years;
* Pregnancy;
* Raynaud's phenomenon, systemic sclerosis or vasospastic diathesis;
* Severe hyponatremia (Na\<130mEq/L);
* Acute mesenteric ischemia;
* Acute myocardial infarction;
* Cardiogenic shock;
* Current use of vasopressor before randomization
* Expected ICU stay less than 24 hours
* Enrolled in another study;
* Refusal to consent.

Primary outcomes:
measure: 28-day mortality
timeFrame: 28-day from randomization
Secondary outcomes:
measure: 90-days mortality
timeFrame: 90 days after randomization
measure: Days alive and free of mechanical ventilation
timeFrame: 28 days after randomization
measure: Days alive and free of vasopressors
timeFrame: 28 days after randomization
measure: Days alive and free of renal replacement therapy
timeFrame: 28 days after randomization
measure: SOFA score in 24 hours
timeFrame: 24 hours after ICU admission
measure: SOFA score in 96 hours
timeFrame: 96 hours after randomization
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo
state: Sao Paulo/SP
Study officials:
affiliation: Department of Anesthesia and Critical Care, Intensive Care Unit - ICESP
name: Cristiane M Zambolim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hajjar LA, Zambolim C, Belletti A, de Almeida JP, Gordon AC, Oliveira G, Park CHL, Fukushima JT, Rizk SI, Szeles TF, Dos Santos Neto NC, Filho RK, Galas FRBG, Landoni G. Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients: The VANCS II Randomized Clinical Trial. Crit Care Med. 2019 Dec;47(12):1743-1750. doi: 10.1097/CCM.0000000000004023.
Clinical trial NCT03471013: Impact of Caregiver Beliefs on Adherence to Antipsychotic Medications in Patients With Schizophrenia
Official title: Impact of Caregiver Beliefs on Adherence to Antipsychotic Medications in Patients With Schizophrenia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: DSM-5 Schizophrenia
Keywords: schizophrenia
beliefs
caregiver
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2018-03-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of scizophrenia

Brief summary: Only one third of patients with schizophrenia are observant to their treatment knowing that the lack of adherence to treatment is one of the most important predictors of relapse.

Recent work shows that the erroneous or negative beliefs of patients with schizophrenia regarding antipsychotic treatment are associated with poor compliance.

The hypothesis is that negative beliefs about the antipsychotic treatment of caregivers of patients with schizophrenia may be associated with a higher risk of poor compliance compared to caregivers with positive beliefs about treatment.

The primary purpose is to explore the correlation between caregiver beliefs about treatment and patient compliance, taking into account the level of caregiver-patient link.

Detailed description: Non-interventional cross-sectional exploratory study with a single visit for patients with schizophrenia and their caregivers, who agreed to participate in the protocol.

Eligibility criteria: Inclusion Criteria:

* Patient over 18 years old
* With a diagnosis of schizophrenia according to DSM-5 criteria
* Accompanied by his main caregiver, who will be able to complete the questionnaires after having signed the information form.
* Treated with one or more antipsychotics.
* Able to complete the questionnaires related to the protocol
* Having agreed to sign the information form.

Exclusion Criteria:

* Not understanding French, unable to answer questions linguistically
* Presenting an organic pathology and / or cognitive deterioration likely to hinder a good understanding of the interview
* Having already participated in the study
* presenting disorders related to the use of substances of severe intensity (such as acute intoxication, withdrawal syndrome or any state of delirium)

Primary outcomes:
measure: Assessment of the correlation between caregiver beliefs about treatment and patient compliance
timeFrame: At day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Chu Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Ludovic SAMALIN
role: PRINCIPAL_INVESTIGATOR
References: