louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02336620: Balanced Salt Solution VS. Normal Saline Solution in Septic Shock
Official title: Balanced Salt Solution Versus Normal Saline Solution During Initial Resuscitation in Severe Sepsis or Septic Shock Children: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Shock, Septic
Sepsis
Keywords: Severe sepsis, Balanced Salt Solution, Normal Saline
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
First posted: 2015-01-13
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Purpose of this study is to determine the impact of balanced salt solution versus chloride rich solution on clinical outcomes in paediatric severe sepsis or septic shock

Detailed description: The surviving sepsis campaign guideline recommended the isotonic crystalloids as the first choice of initial fluid resuscitation. The isotonic crystalloids are including chloride-rich solution (eg.NSS) and balanced salt solution. Retrospective study showed normal saline can induced hyperchloremic metabolic acidosis and acute kidney injury. However, no randomized controlled trial compare efficacy between the balanced salt solution and chloride rich solution.

Eligibility criteria: Inclusion Criteria:

* children younger than 18 year old who has severe sepsis or septic shock
* inform consent

Exclusion Criteria:

* children who had shock from other aetiologies
* end stage disease or severe congenital anomaly
* refuse to inform consent

Primary outcomes:
measure: incidence of hyperchloremic metabolic acidosis
timeFrame: 48 hour
Secondary outcomes:
measure: 28 day and 90 day mortality rate
timeFrame: 28 days and 90 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Pediatric,Ramathibodi Hospital
Study officials:
affiliation: Ramathibodi Hospital, Bangkok
name: Nattachai Anantasit, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04276220: Prevalence of wtATTR-CM After Carpal Tunnel Release Surgery
Official title: Prevalence of Wild-Type Transthyretin Cardiac Amyloidosis Among Patients Undergoing Carpal Tunnel Release Surgery - A Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transthyretin Amyloidosis
Transthyretin Cardiac Amyloidosis
Wild-Type Transthyretin-Related (ATTR)Amyloidosis
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
First posted: 2020-02-19
Enrollment: 25
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Patients above the age of 60 will be recruited at their carpal tunnel release surgery. Biopsies will be taken from the wrist and examined for the presence of amyloid protein. A amyloid-positive biopsy will refer the patients for cardiac examination including blod- and urine samples examined for transthyretin.

If the result of the cardiac examination is suspected cardiac amyloidosis, the patient will be referred for a diagnostic TC99-DPD scintigraphy. If the scintigraphy is positive, the patient will be referred for right heart catherization (RHC) and an exercise test.

Myocardial biopsies will be taken at the RHC and examined with electron microscopy and high resolution respirometry.


Eligibility criteria: Inclusion Criteria:

* Males above 65 years of age, females above 75 years of age.
* Scheduled idiopathic carpal tunnel release surgery.
* Informed written consent.

Exclusion Criteria:

* Operation by other indication, e.g.
* Fracture
* Ganglion
* Known amyloidosis

Primary outcomes:
measure: Prevalence of wild-type transthyretin cardiac amyloidosis in patients undergoing surgery for idiopathic Carpal Tunnel Syndrome Surgery where biopsies from transverse carpal ligament stain positive for amyloid.
timeFrame: Through study completion, 6 years.
Secondary outcomes:
measure: Levels of transthyretin in blood and urine from patients with suspected wild-type transthyretin cardiac amyloidosis
timeFrame: Has been added after study start, will run through study completion, 3 years.
measure: Comparing patients diagnosed with wild-type transthyretin cardiac amyloidosis due to screening with age and gender matched clinically diagnosed ATTRwt patients.
timeFrame: Through study completion, 6 years.
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
state: Jylland
Study officials:
References:
Clinical trial NCT01491282: Study of the Effect of Vagus Nerve Stimulation on Human Brown Adipose Tissue Activity
Official title: Brown Adipose Tissue After Vagus Nerve Stimulation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Keywords: human brown adipose tissue activity
obesity
energy metabolism
adaptive thermogenesis
Lead sponsor: Maastricht University
Sponsor class: OTHER
First posted: 2011-12-13
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postoperative patients treated with vagus nerve stimulation for refractory epilepsy

Brief summary: To evaluate the effect of vagus nerve stimulation for refractory epilepsy on the activity of human brown adipose tissue.


Eligibility criteria: Inclusion Criteria:

* Subjects treated with VNS for epilepsy, aged 18-65 years, with a Body Mass Index (BMI) ≤ 28 kg/m2.

Exclusion Criteria:

* Body Mass Index \> 28 kg/m2
* Daily epileptic insults.
* Subjects that need 'Rapid Cycling' VNS to control their frequency of epileptic insults.
* Psychological unstable subjects (as judged by the treating neurologist).
* subjects with mental retardation (as judged by the treating neurologist).
* subjects with severe behaviour disorders (as judged by the treating neurologist).
* Pregnant subjects.
* Subjects that previously underwent high dose radiation for diagnostic or therapeutic purposes (radiotherapy, high frequency CT-scans).
* The use of the following medication is an exclusion criterium;

  * ß-blockers,
  * Ketogenic diet

Primary outcomes:
measure: human brown adipose tissue activity
timeFrame: baseline and 2 weeks after
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
Study officials:
affiliation: Department of Human Biology, Maastricht University
name: Wouter D. van Marken Lichtenbelt, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vijgen GH, Bouvy ND, Leenen L, Rijkers K, Cornips E, Majoie M, Brans B, van Marken Lichtenbelt WD. Vagus nerve stimulation increases energy expenditure: relation to brown adipose tissue activity. PLoS One. 2013 Oct 23;8(10):e77221. doi: 10.1371/journal.pone.0077221. eCollection 2013.
Clinical trial NCT01679782: Involvement of Nervous System in Muscle Weakness in COPD Patients
Official title: Phase 1 Impact of Nocturnal Desaturations on Central Motor Drive in COPD Patients: A New Insight on the Systemic Effects of the Disease.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD, nervous system, peripheral muscle dysfunction
Lead sponsor: 5 Santé
Sponsor class: OTHER
Collaborators: name: M2H laboratory, Montpellier University
name: ANRT, National French Agency for Technological Researches
First posted: 2012-09-06
Enrollment: 137
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Two groups of COPD patients and one group with healthy sedentary subjects

Brief summary: The purpose of this study is to determine whether nervous system alterations and motor drive failure can contribute to muscle weakness in COPD during voluntary movement. If necessary, we will look after the role of nocturnal hypoxia in these alterations.

Detailed description: COPD is a common disease that induces many systemic repercussions. Among these, peripheral muscle dysfunction is particularly deleterious because it leads to the decreases of the level of activity and the quality of life for patients. Movement involves activation of many structures, from the instructor, i.e. the brain, to the effector, i.e. the muscle. Netherless, the studies which have described peripheral muscle dysfunction have been focused on the muscle, so they have proposed a reducing vision of the phenomenon. Other studies have reported cerebral alterations in COPD, like cognitive disturbance, increase of the neuronal conduction time, and decrease of the white matter density, and were associated with chronic hypoxemia. Such alterations are consistent with the existence of a decrease of the central motor drive during voluntary movement in COPD patients. Therefore the study will aim to determine precisely which mechanisms are involved in peripheral muscle dysfunction in copd.

Eligibility criteria: Inclusion Criteria:

* COPD Patients at stage 2 and 3
* Healthy sedentary subjects

Exclusion Criteria:

* Epilepsy, pace-maker, nervous disorders

Primary outcomes:
measure: Level of voluntary activation
timeFrame: 2h
Secondary outcomes:
Other outcomes:
Locations:
city: Lodève
country: France
facility: Clinique du Souffle La Vallonie
Study officials:
affiliation: M2H laboratory, Montpellier
name: Alain AV Varray, Pr
role: STUDY_DIRECTOR
References:
citation: Alexandre F, Heraud N, Sanchez AM, Tremey E, Oliver N, Guerin P, Varray A. Brain Damage and Motor Cortex Impairment in Chronic Obstructive Pulmonary Disease: Implication of Nonrapid Eye Movement Sleep Desaturation. Sleep. 2016 Feb 1;39(2):327-35. doi: 10.5665/sleep.5438.
Clinical trial NCT01900782: Efficacy and Safety Study of Subcutaneous Secukinumab in Treatment of Subjects With Moderate to Severe Chronic Plaque-type Psoriasis as Compared to Etanercept and Placebo.
Official title: A Randomized, Double-blind, Double-dummy, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, Compared to Placebo and Etanercept, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Psoriasis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-07-16
Enrollment: 0
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: This withdrawn study was to assess the safety and efficacy of secukinumab compared to etanercept and placebo in patients who have moderate to severe, chronic, plaque-type psoriasis.


Eligibility criteria: Inclusion Criteria:

* Chronic plaque-type psoriasis, moderate to severe
* Candidate for systemic therapy defined as having psoriasis not adequately controlled by: topical treatment, phototherapy and/or previous systemic therapy

Exclusion Criteria:

* Forms of psoriasis other than chronic plaque-type
* Ongoing use of treatments not allowed for psoriasis

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: PASI (psoriasis area and severity index) and IGA (investigator's global assessment)
timeFrame: Week 12
Secondary outcomes:
measure: PASI (psoriasis area and severity index) and IGA (investigator's global assessment)
timeFrame: Week 52
measure: Vital signs, laboratory values, electrocardiograms (ECG), adverse events
timeFrame: Week 12 and 52
measure: Patient reported outcome questionnaires
timeFrame: Week 12 and 52
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02195882: Effect of an Exercise Program of the Scapular Muscle Stabilizers in Amateur Kayakers Shoulder Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Keywords: strength training
scapular stabilization
kayakers.
Lead sponsor: CEU San Pablo University
Sponsor class: OTHER
First posted: 2014-07-21
Enrollment: 11
Sex: ALL
Minimum age (years): 14
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a specific strengthening program for the stabilizing scapular muscle can reduce shoulder pain of amateur kayaker.


Eligibility criteria: Inclusion Criteria:

* There Have Been practicing kayaking over 3 years.
* There Have Been shoulder pain during sports at least 1 month of evolution

Exclusion Criteria:

* Shoulder pain was caused by a traumatic injury.
* To be in medical, pharmacological or shoulder physiotherapy treatment during the study.
* To have been surgically intervened in the shoulder

Primary outcomes:
measure: Change in pain level during kayakergometer test
timeFrame: participants will be followed for the duration of kayakergometer test, an expected average of 30 minutes
Secondary outcomes:
measure: change in the time of appearance of the symptoms during kayakergometer test.
timeFrame: participants will be followed for the duration of kayakergometer test, an expected average of 30 minutes
Other outcomes:
Locations:
city: Boadilla del Monte
country: Spain
facility: San Pablo CEU University
state: Madrid
Study officials:
References:
Clinical trial NCT04240782: Market to MyPlate: Investigating the Impact of a Nutrition and Hands-On Cooking Intervention
Official title: Market to MyPlate: A Cluster Randomized Trial Investigating the Impact of a Nutrition and Hands-On Cooking Intervention on Dietary, Cooking, and Shopping Behaviors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fruit and Vegetable Consumption
Cooking Frequency
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Recent peer-reviewed research indicates that low-income families are at higher risk for unhealthy dietary intake and associated poor health outcomes. Interventions that teach individuals from low-income families about cooking and healthy eating are warranted to improve overall dietary behaviors. The purpose of this study is to evaluate the impact of the Market to MyPlate Program on participants' reported cooking, shopping, and dietary behaviors using a cluster randomized trial design, where class cohorts are randomly assigned to education with produce allocations, education only, or control conditions. A secondary aim is to collect program feedback and better understand facilitators and barriers to farmer's market use and food waste reduction.


Eligibility criteria: Inclusion Criteria:

* Recruited from SNAP-Ed eligible site (site where the majority of participants are eligible for US food assistance programs)
* Must be 18 years or older, or parent of any age with child(ren) to participate in data collection (all ages including children could participate in intervention)

Exclusion Criteria:

• Participated in an Extension nutrition education program in the last year

Primary outcomes:
measure: Self-reported vegetable consumption
timeFrame: 7 weeks
measure: self-reported shopping behaviors
timeFrame: 7 weeks
measure: self-reported cooking behaviors
timeFrame: 7 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Urbana
country: United States
facility: University of Illinois
state: Illinois
Study officials:
References:
Clinical trial NCT04132882: A Compassionate Use Program to Provide Access to Sodium Thiosulfate
Official title: A Compassionate Use Program to Provide Access to Sodium Thiosulfate for the Protection From Cisplatin-Induced Hearing Loss in Children Who Had Standard-risk Hepatoblastoma
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Cisplatin-Induced Hearing Loss in Children Who Had Standard-risk Hepatoblastoma
Keywords: Cisplatin
Hearing Loss
Hepatoblastoma
Lead sponsor: TRPHARM
Sponsor class: INDUSTRY
Collaborators: name: Fennec Pharma
First posted: 2019-10-21
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT

Brief summary: This is a CUP which is designed to provide treatment access of STS to pediatric patients for the protection from Cisplatin-Induced Hearing Loss in children who had standard-risk hepatoblastoma.

Approximately 10 patients will be treated as part of this program as specified below:

Sodium Thiosulfate vials i.v. 80 mg/mL.

This Compassionate Use Program for STS will consist of 2 phases:

Screening:

Patients will only be able to participate in this CUP if they meet the eligibility criteria.

Treatment:

Any clinical assessments, physical examinations, and dosage changes will be determined by the treating physician as per local standard medical practice.

All serious adverse events (SAEs) will be reported. All related non-serious adverse events (AEs) will be reported where "related" means any event where a causal relationship between STS and the event is at least, a reasonable possibility. All non-serious AEs leading to dose modification or discontinuation will be reported. Pregnancies, outcomes of pregnancies, and exposure through breastfeeding will also be reported.


Eligibility criteria: Inclusion Criteria:

I-1. Children older than 1 month and younger than 18 years of age who had standard-risk hepatoblastoma that had not been treated previously with STS and receive cisplatin.

I-2. A written informed consent was provided from all the patients and/or parents or legal guardians of children.

Exclusion Criteria:

E-1. Any previous participation in an STS clinical trial. E-2. Participation in another clinical study with an investigational product during the most recent chemotherapy course.

E-3. Patients with a known hypersensitivity to STS or any of the excipients of the product.

E-4. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) or major surgery within 3 weeks prior to STS treatment.

E-5. Persistent toxicities (\>Common Terminology Criteria for Adverse Event (CTCAE) CTCAE grade 2) caused by previous cancer therapy, excluding alopecia.

E-6. Breast feeding or pregnant women.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University School of Medicine
Study officials:
References:
Clinical trial NCT04258982: The Copmparison of Accuracy of PtcCO2 and in PetCO2 in COPD Patients With NIV Treatment
Official title: The Copmparison of Accuracy of PtcCO2 and in PetCO2 in COPD Patients With NIV Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD
Lead sponsor: Guangzhou Medical University
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: AECOPD patients with type II respiratory failure who need NIV treatment

Brief summary: The chronic obstructive pulmonary disease (COPD) patients with type II respiratory failure always needs PaCO2 test to monitor the changes of disease. Method used mostly nowadays to detect PaCO2 is arterial puncture which is accurate but is invasive, painful and non-dynamic. Noninvasive measurement methods includes end-tidal CO2 (PetCO2), transcutaneous CO2 (PtcCO2) which can monitor the PaCO2 dynamically and noninvasively, but their accuracy is in controversy. Common PetCO2 is especially inaccurate in COPD patients while our team find that the accuracy can be improved by prolong expiration method (PetCO2 (P)).So the investigators want to compare the accuracy of PtcCO2 and PetCO2(P) in AECOPD patients during noninvasive ventilation(NIV).


Eligibility criteria: Inclusion Criteria:

* AECOPD patients with type II respiratory failure who need NIV treatment

Exclusion Criteria:

* hemodynamics is unstable;
* any other lung disease despite COPD;
* other diseases influencing experiments: Cognitive impairment disease mouth and nose trauma.

Primary outcomes:
measure: partial arterial pressure of end-tidal CO2 measured by prolong expiration method [PetCO2(P)]
timeFrame: 2 hours
measure: partial arterial pressure of transcutaneous CO2 (PtcCO2)
timeFrame: 2 hours
measure: partial arterial pressure of carbon dioxide (PaCO2)
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University.
state: Guangdong
Study officials:
References:
Clinical trial NCT01331382: Cerebral Blood Flow Effects of Resveratrol and Piperine in Humans
Official title: Effects of Resveratrol Alone or in Combination With Piperine on Cerebral Blood Flow Parameters and Cognitive Performance in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Resveratrol
Piperine
Cerebral blood flow
Near- infrared spectroscopy
Bioavailability
Lead sponsor: Northumbria University
Sponsor class: OTHER
First posted: 2011-04-08
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL

Brief summary: Resveratrol is associated with a plethora of physiological effects in humans, including modulation of cerebral blood flow, despite apparently poor bioavailability. This study investigated whether the physiological effects of resveratrol could be affected when co-supplemented with piperine, an alkaloid which may be able to enhance the bioavailability of resveratrol.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 18-35 years old
* Healthy
* Non-smoker

Exclusion Criteria:

* Not proficient in English
* Taking medication or herbal supplements
* Pregnant or breast feeding
* Heavy caffeine consumer
* History of head trauma, migraines, learning difficulties, ADHD, gastrointestinal problems.
* Food allergies of intolerances

Primary outcomes:
measure: Modulation of levels of total haemoglobin
timeFrame: 80 minutes following treatment administration
measure: Modulation of levels of deoxygenated haemoglobin
timeFrame: 80 minutes following treatment administration
measure: Modulation of levels of oxygenated haemoglobin
timeFrame: 80 minutes following treatment administration
Secondary outcomes:
measure: Number of participants displaying significant modulation of cognitive performance
timeFrame: 40-80 minutes post dose
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Brain performance and nutrition research centre, Northumbria university
state: Tyne and Wear
Study officials:
affiliation: Northumbria University
name: Emma L Wightman
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wightman EL, Reay JL, Haskell CF, Williamson G, Dew TP, Kennedy DO. Effects of resveratrol alone or in combination with piperine on cerebral blood flow parameters and cognitive performance in human subjects: a randomised, double-blind, placebo-controlled, cross-over investigation. Br J Nutr. 2014 Jul 28;112(2):203-13. doi: 10.1017/S0007114514000737. Epub 2014 May 7.