louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06594978: Effects of Dual-site Anodal Transcranial Direct Current Stimulation on Attention, Decision-making and Working Memory During Sports Fatigue in Elite Soccer Athletes
Official title: Effects of Dual-site Anodal Transcranial Direct Current Stimulation on Attention, Decision-making and Working Memory During Sports Fatigue in Elite Soccer Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sports Fatigue
Keywords: transcranial direct current stimulation
primary motor cortex
prefrontal cortex
cognitive function
sports fatigue
Lead sponsor: Beijing Sport University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Investigation of the effects of dual-site anodal transcranial direct current stimulation over the dorsolateral prefrontal cortex or primary motor cortex on attention, decision-making and working memory during sports fatigue in elite soccer athletes


Eligibility criteria: Inclusion Criteria:

* elite soccer athletes

Exclusion Criteria:

* goalkeepers
* pregnancies
* family history of epilepsy
* metallic head implants
* neurological, psychiatric, or musculoskeletal disorders
* severe sports injuries

Primary outcomes:
measure: Accuracy of the Stroop task
timeFrame: immediately after the tDCS/sham-tDCS intervention
measure: Reaction times of the Stroop task
timeFrame: immediately after the tDCS/sham-tDCS intervention
measure: Net score in the Iowa Gambling task
timeFrame: immediately after the tDCS/sham-tDCS intervention
measure: Hits in the 2-back task
timeFrame: immediately after the tDCS/sham-tDCS intervention
measure: Misses in the 2-back task
timeFrame: immediately after the tDCS/sham-tDCS intervention
measure: Reaction times in the 2-back task
timeFrame: immediately after the tDCS/sham-tDCS intervention
measure: Index d' in the 2-back task
timeFrame: immediately after the tDCS/sham-tDCS intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Sports, Exercise and Brain Sciences Laboratory, Sports Coaching College, Beijing Sport University, Beijing 100084, China
state: Haidian
Study officials:
References:
Clinical trial NCT00197678: Multivitamin Dosage Regimens in the Prevention of Adverse Pregnancy Outcomes Among HIV-Positive Women
Official title: Comparison of Two Multivitamin Dosage Regimens in the Prevention of Adverse Pregnancy Outcomes Among HIV-Positive Women From Tanzania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: HIV
AIDS
Multivitamins
Pregnancy Outcomes
Women
Tanzania
Africa
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Muhimbili University of Health and Allied Sciences
First posted: 2005-09-20
Enrollment: 1141
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to examine effects of daily administration of multivitamin supplements at doses resembling the Recommended Dietary Allowance (RDA) during pregnancy to HIV positive women decreases the risks of low birth weight (\<2500 g), and pre-term birth (\< 37 weeks gestation), compared to multivitamin supplements at doses above the RDA.

Detailed description: This is a randomized clinical trial conducted to examine effects of daily administration of multivitamin supplements at doses resembling the Recommended Dietary Allowance (RDA) during pregnancy to HIV positive women decreases the risks of low birth weight (\<2500 g), and pre-term birth (\< 37 weeks gestation), compared to multivitamin supplements at doses above the RDA. All women receive standard prenatal care, including nevirapine for the prevention of mother-to-child transmission of HIV.

Eligibility criteria: Inclusion Criteria:

- HIV-positive pregnant women who are between 12 and 27 weeks gestation who intend to stay in Dar es Salaam until delivery.

Primary outcomes:
measure: Low birthweight (< 2500 g)
timeFrame: Delivery
measure: Pre-term birth (< 36 weeks gestation)
timeFrame: Monthly until the 32nd week of pregnancy, once every 2 weeks from 32nd to 36th week
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard School of Public Health
state: Massachusetts
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Wafaie W. Fawzi, MD,DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kawai K, Kupka R, Mugusi F, Aboud S, Okuma J, Villamor E, Spiegelman D, Fawzi WW. A randomized trial to determine the optimal dosage of multivitamin supplements to reduce adverse pregnancy outcomes among HIV-infected women in Tanzania. Am J Clin Nutr. 2010 Feb;91(2):391-7. doi: 10.3945/ajcn.2009.28483. Epub 2009 Nov 25.
Clinical trial NCT01332578: A Comparison of Solid and Soluble Forms of Cold and Influenza Remedies
Official title: A Comparison of Solid and Soluble Forms of Cold and Influenza Remedies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Common Cold
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-04-11
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The study is designed to investigate whether paracetamol from a hot remedy reaches the plasma faster than standard paracetamol tablets. The study will also assess the gastrointestinal transit of two oral cold and influenza ('flu') formulations using gamma scintigraphy. It is postulated that paracetamol in solution, such as from cold and 'flu' hot remedies, provides a greater early exposure compared to standard paracetamol tablets. In addition, the pharmacokinetic (PK) profile of paracetamol in the two formulations will be investigated.


Eligibility criteria: * Healthy male volunteers
* Body mass index between 18.0-29.9 kg/m\^2

Primary outcomes:
measure: Time to Reach Plasma Paracetamol Concentration of 0.25 μg/mL (Microgram Per Milliliter)
timeFrame: Blood samples taken within 15-30 minutes prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose
Secondary outcomes:
measure: Area Under the Concentration/Time Curve From 0 to 30 Minutes (Min) (AUC 0-30 Min)
timeFrame: Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose
measure: AUC (0-60 Min)
timeFrame: Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose
measure: Maximum Plasma Concentration (Cmax)
timeFrame: Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose
measure: Time to Maximum Plasma Concentration (Tmax)
timeFrame: Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose
measure: Time to Onset of Gastric Emptying
timeFrame: Baseline to 10 hours
measure: Time to Completion of Gastric Emptying
timeFrame: Baseline to 10 hours
measure: Time to Onset and Completion of Disintegration of Reference Tablets
timeFrame: Baseline to 10 hours post dose
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: BIO-IMAGES Research Ltd.
state: Scotland
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01417078: A Pharmacokinetic Study of a Single-Dose of Diazepam Nasal Spray in Adult Epileptic Patients Experiencing a Seizure Episode
Official title: An Open-Label Study to Determine the Pharmacokinetics of a Single Dose of Diazepam Nasal Spray in Adult Epileptic Patients Experiencing a Seizure Episode for Which Acute Treatment With a Benzodiazepine is Clinically Indicated
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epilepsy
Lead sponsor: Acorda Therapeutics
Sponsor class: INDUSTRY
First posted: 2011-08-16
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the pharmacokinetics of Diazepam Nasal Spray following a single dose in epileptic patients experiencing a seizure episode.


Eligibility criteria: Inclusion Criteria:

* Provide signed informed consent for study participation.
* General good health with no clinically significant unstable abnormalities.
* Diagnosis of epilepsy.

Exclusion Criteria:

* Individuals receiving warfarin (Coumadin®) or dabigatran (Pradaxa®).
* Use of any investigational drug within 30 days.
* Blood or plasma donation within 30 days.
* Not willing or unable to tolerate blood draws.

Primary outcomes:
measure: Pharmacokinetic (PK) Parameter: Maximum Measure Plasma Concentration (Cmax),
timeFrame: Pre-dose, 10, 15, 30, and 45 mins, and 1, 1.5, 2, 4, 6, 9,and 12 hours
measure: Pharmacokinetic (PK) Parameter: Time to Maximum Plasma Concentration (Tmax)
timeFrame: Pre-dose, 10, 15, 30, and 45 mins, and 1, 1.5, 2, 4, 6, 9,and 12 hours
measure: Pharmacokinetic (PK) Parameter: Area Under The Concentration Curve From Time 0 to 12 Hours (AUC(0-12)) and AUC Time to Last Measurable Plasma Concentration
timeFrame: Pre-dose, 10, 15, 30, and 45 mins, and 1, 1.5, 2, 4, 6, 9,and 12 hours
Secondary outcomes:
measure: Number of Patients With Treatment Emergent Adverse Events (TEAEs)
timeFrame: Pre-dose to 48 hours post-dose
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurology Clinics at St Joseph's Hospital
state: Arizona
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Neuronex, Inc.
name: David P Ward, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02931578: Glycemic Index of Commonly Consumed Sweeteners
Official title: Glycemic Index of Commonly Consumed Sweeteners
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy
Keywords: glycemic index
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2016-10-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine the glycemic index of commonly consumed sweeteners.

Detailed description: This three arm study is intended to add to scientific knowledge by providing accurate assessments of the glycemic index commonly consumed food items. This will be used in the scientific literature to assess the glycemic index of foods containing various sweeteners. Participants will be monitored for a total of 10 weeks.

The glycemic index is defined as the "incremental area under the glucose response curve after standard amount of carbohydrate relative to that of a control food (white bread or glucose) is consumed." In general, the glycemic index quantifies the relative effect of the carbohydrate content of the food on resultant blood glucose.

Eligibility criteria: Inclusion Criteria:

* BMI 18.5-24.9 (lean)
* no medications
* no weight changes over the previous 6 months (defined as \>=10% change in body weight)

Exclusion Criteria:

* current active participation in a weight loss program (dietary or physical activity focused)
* prior bariatric surgery
* significant medical condition such as cardiac or pulmonary disease, coagulopathy, gastrointestinal disorder, or known history of Type 1 or Type 2 diabetes
* women who are pregnant or lactating
* medications (except for oral contraceptives, thyroxins, drugs for hypertension, drugs for osteoporosis, or vitamins and minerals)
* no major medical or surgical event requiring hospitalization in the past 3 months
* no disease or drugs that influence digestion

Primary outcomes:
measure: Mean Glycemic Index
timeFrame: 2 hours
Secondary outcomes:
measure: Body Mass Index (BMI)
timeFrame: Baseline
measure: Body Mass Index (BMI)
timeFrame: 9 weeks
measure: Percent Fat Mass
timeFrame: Baseline
measure: Percent Fat Mass
timeFrame: 9 weeks
measure: Total Fat Mass
timeFrame: Baseline
measure: Total Fat Mass
timeFrame: 9 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Center for Clinical Investigation Church Street Research Unit
state: Connecticut
Study officials:
affiliation: Yale University
name: Eugene Shapiro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Ania M Jastreboff, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Robert S Sherwin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ludwig DS. The glycemic index: physiological mechanisms relating to obesity, diabetes, and cardiovascular disease. JAMA. 2002 May 8;287(18):2414-23. doi: 10.1001/jama.287.18.2414.
Clinical trial NCT01732978: Are Parents Privileged Listeners Their Baby ?
Official title: Are Parents Privileged Listeners Their Baby ?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Newborn
Keywords: Crying record
Newborn
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2012-11-26
Enrollment: 24
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The crying baby is a sound signal including information relating to this individual identity or related to its physiological or motivational state.

The objective of the study is to determine the implementation of the recognition of individual tone of the baby by his parents and acoustic modulation of the baby based on parental response.

The detailed study of the acoustic structure of crying and analysis of parental perception will determine the dynamics during the first weeks of life of this recognition, and the influence of factors such as parental presence, or breastfeeding .

For this study is organized in three stages: first, the recording of the baby's crying Secondly, a listening test parental soundtracks and third analysis of the acoustic structure of crying and parental response.


Eligibility criteria: Inclusion Criteria:

* born in the University Hospital of Saint Etienne (inborn) whatever its term birth

Exclusion Criteria:

* Congenital oropharyngeal tract preventing vocalization physiological newborn

Primary outcomes:
measure: Crying recorded
timeFrame: Second day of life of the parent's child
Secondary outcomes:
measure: Biological correlation
timeFrame: Second day of life of parents' child
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: Jean Monnet University
name: Nicolas MATHEVON, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01141478: Proton Radiotherapy Plus Sorafenib Versus Sorafenib for Patients With HCC Exceeding San Francisco Criteria
Official title: Randomized Controlled Trial of Proton Beam Radiotherapy + Sorafenib vs. Sorafenib for Patients With Hepatocellular Carcinoma Exceeding San Francisco Criteria
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Carcinoma, Hepatocellular
Keywords: Carcinoma, Hepatocellular
Proton Beam Radiotherapy
Sorafenib
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2010-06-10
Enrollment: 8
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: TREATMENT

Brief summary: This study is designed to determine whether proton beam radiotherapy plus Sorafenib compared to Sorafenib alone will produce the best results for treating patients with Hepatocellular Carcinoma.


Eligibility criteria: Inclusion Criteria:

1. Patients are candidates to receive both proton beam and sorafenib
2. Patients with tumor burden that exceeds San Francisco criteria

Exclusion Criteria:

1. Patients who are candidates for surgical resection
2. Patients with tumor burden within Milan and/or San Francisco criteria
3. Patients who have contraindication to receive proton
4. Patients with contraindication to receive sorafenib including uncontrolled hypertension, coumadin treatment and prior intolerability to the drug
5. Patients treated previously by any locoregional treatment
6. Patients with prior liver transplant
7. Patients with child class C
8. Patients with model for end-stage liver disease (MELD) score of \> 25
9. Patients with other comorbid diseases that may impact survival
10. Patients with ongoing alcohol intake
11. Patients with active sepsis
12. Patients with gastrointestinal bleeding within a week
13. Patients unwilling to sign informed consent form
14. Patients with history of noncompliance

Primary outcomes:
measure: Overall Survival Rate Between Time of Consent and Time of Death
timeFrame: Change between time of informed consent and primary completion date of study, an average of 4 years per participant
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
Study officials:
affiliation: Loma Linda University Medical Center
name: Michael deVera, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04327778: Automate Music Therapy for the Management of Behavioral Disorders in Nursing Homes
Official title: Automate Music Therapy for the Management of Behavioral Disorders in Nursing Homes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer Disease
Major Neurocognitive Disorder
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Alzheimer disease is the most common neurodegenerative brain disease that causes cognitive impairment in the elderly but also behavioral and psychological symptoms. Among these symptoms, agitation is one of the most dangerous because it put the patient and their caregivers in danger. Sleep disorders can be the cause of many psychiatric symptoms leading directly or indirectly to agitation. Music therapy is the non-drug therapy which has been shown to be the most effective in managing agitation and sleep disorders. With the MAGE protocol, the investigators propose to take care of behavioral disorders in severe Alzheimer patients living in nursing home through sequences of music therapy (stimulation, relaxation) automatically initiated by an actigraph that will detect sleep disorders. These subjects will be exposed for 2 weeks over a month. Behavioral and sleep disorders will be evaluated objectively by actigraphy but also by standardized scales, as the others neuropsychiatric symptoms found classically in this disease. Thanks to this project, the investigators hope to improve the quality of life of these patients by preventing them from putting themselves in danger, by reducing their neuropsychiatric symptoms and their use of medication, which has often deleterious side effect and also by reducing the workload of caregivers.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 60 years old
* Male or Female
* Patients with a diagnosis of Alzheimer disease according to the criteria of NINCDS-ADRDA or typical or atypical Alzheimer disease
* MMSE \< 20
* Patient residing in nursing home
* Voluntary, written and informed consent of the patient himself or its legal representative (guardian/curator)
* Affiliation to a social security system

Exclusion Criteria:

* Prescription of a new psychotropic treatment (hypnotic, anxiolytic, antidepressant, antipsychotic) in week prior to the evaluation
* Hearing loss preventing the patient from responding perfectly to the therapeutic solutions provided

Primary outcomes:
measure: Neuropsychiatric tests scores
timeFrame: At 3 months
measure: Nightly agitation
timeFrame: At 3 month
Secondary outcomes:
measure: Number of falls
timeFrame: At 3 months
measure: Sleeping troubles
timeFrame: At 3 months
measure: Rate of anxiety
timeFrame: At 3 months
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
References:
Clinical trial NCT02132078: Epidemiology of Diverticulitis in Lung Transplant Recipients
Official title: Long-term Follow-up of Lung Transplant Recipients With Diverticulitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Transplant Recipients
Diverticulitis
Keywords: Lung transplant recipients
diverticulitis
immunosuppression
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-05-06
Enrollment: 18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We want to retrospectively analyse our prospective database of lung transplant recipients at our institution between 1992 and 2013 with diverticulitis episodes.

Brief summary: The purpose of this study is to assess incidence, treatment modalities and outcome of complicated and uncomplicated diverticulitis in highly immunosuppressed lung transplant recipients (LTRs) in order to establish improved treatment strategies in this high risk patient collective.

Detailed description: Sigmoid diverticulitis is common and potentially problematic in immunosuppressed patients. The choice between conservative and surgical treatment for uncomplicated diverticulitis remains unclear, as well as the value of the Hartmann's procedure (HP) for complicated diverticulitis.

Our aim is to assess incidence, treatment options and outcome of complicated and uncomplicated diverticulitis in highly immunosuppressed lung transplant recipients (LTRs) by retrospectively analysing our prospective database of around 400 lung transplant recipients transplanted between 1992 and 2013.

Eligibility criteria: Inclusion Criteria:

* Lung transplant recipient
* Diverticulitis

Exclusion Criteria:

* none

Primary outcomes:
measure: Epidemiology of Diverticulitis in Lung Transplant Recipients
timeFrame: January 1992- December 2013 (22 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Department of Visceral- and Transplant Surgery, University Hospital of Zurich
Study officials:
References: