louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03568513: Effect of Curcumin on Gut Microbiota in IBS
Official title: Effect of Curcumin Food Supplement on Gut Microbiota in Children With Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: Curcumin
IBS and microbiota
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Clinical & Translational Science Institute of Southeast Wisconsin
First posted: 2018-06-26
Enrollment: 4
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of curcumin food supplement on gut microbiota of children with irritable bowel syndrome (IBS) and to review any correlation between the changes in the microbiota with symptoms.

Detailed description: This is a prospective, placebo-controlled, double blinded, randomized control trial. This study will evaluate the effect of curcumin food supplement on gut microbiota of children with irritable bowel syndrome. Curcumin is a commonly used spice in Asian cooking and has a very good safety profile. Developing preparation of this compound for targeted delivery in the GI tract would provide a novel way to treat common FGID. This study will provide preliminary data for future studies to evaluate the role of gut microbiota in the pathophysiology of pain predominant FGID and how food supplements can be used to manipulate the microbiota.

Eligibility criteria: Inclusion Criteria:

* 10 to 18 years old
* Fulfill the Rome IV criteria for diarrhea predominant IBS
* English speaking
* Able to swallow curcumin/placebo capsules

Exclusion Criteria:

* Weigh less than 35 kg
* On any form of dietary restrictions
* Taken probiotics one month before enrollment
* Antibiotic treatment one month before enrollment
* IBD
* Celiac disease
* Peptic ulcer disease
* H. Pylori gastritis
* Abnormality of gastrointestinal tract
* Previous abnormal endoscope
* Previous abdominal surgeries
* Gall stones
* Biliary tract obstructions
* Liver pathologies
* Liver failure
* Active GI infection
* Positive stool cultures
* Drug or alcohol abuse
* Concomitant immunological/hematological/neoplastic/heart/ renal/pulmonary condition
* Any other medical condition or taking any form of drug(s) which can explain the current symptoms
* Take oral or intravenous drugs which could have potential drug interaction with curcumin
* Lactating or pregnant or planning to become pregnant
* Developmental delay
* Parents that are developmentally delayed
* Have a diet high in curcumin/turmeric

Primary outcomes:
measure: Alteration in Gut Microbiota
timeFrame: 8 weeks
Secondary outcomes:
measure: Comparison of GI Symptoms
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Manu Sood, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01214213: Non-Specific Chronic Back Pain; Insight From Spatial Aspects of Lumbar Spinal Muscle Activation
Official title: NON-SPECIFIC CHRONIC BACK PAIN; INSIGHT FROM SPATIAL ASPECTS OF LUMBAR SPINAL MUSCLE ACTIVATION
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2010-10-04
Enrollment: 57
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic non-spesific low back pain and healthy control subjects

Brief summary: There is evidence for altered muscle activity patterns in individuals with non-specific chronic back pain (NSCBP). It is unknown why these alterations in activation pattern occur and how they may be linked to pain experience and to the development of CNSBP. The main objective of this study is to investigate the spatial aspects of muscle activation in relation to fatigue/endurance and CNSBP. A novel approach, utilizing a new multi-channel surface-EMG (MCsEMG) technique will be applied in this project to get insight in fundamental mechanisms related to motor control and fatigue/endurance. In this project data from healthy persons and from patients with NSCBP will be collected and analyzed. NSCBP patients will be compared to healthy persons. To minimize heterogeneity between groups the subject's age range will be from 30 - 50 years. The investigators main hypothesis is that motor control mechanisms of the lumbar muscles are disturbed in NSCBP patients compared to normals, explaining the reduced tolerance for static postures. There has been little investigation of the lumbar musculature with MCsEMG recordings. The lumbar musculature has a complex organization; many, relatively small muscles, in a restricted area. Utilizing two HDsEMG grids with 252 Ag/AgCl contacts will be the superior non-invasive method to investigate motor control mechanisms in this region, and further the investigators understanding of neuromuscular adaptations related to NSCBP. The project may demonstrate changes that will lead us to new insight and new strategies for the treatment of back pain.


Eligibility criteria: Inclusion Criteria:

* patients
* diagnosed with chronic NSCBP \>3 months duration
* healthy controls
* no back pain.

Exclusively exclusion criteria for this group will be back pain in the previous year or back pain lasting longer than one week in previous 3 years.

Exclusion Criteria:

* anamnesis of medical or drug abuse
* surgery on the musculoskeletal system of the trunk
* known congenital malformation of the spine or scoliosis
* body mass index \>27 kg/m2
* systemic-neurological-degenerative disease
* history of stroke
* psychiatric disorder
* pregnancy and abnormal blood pressure.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stavern
country: Norway
facility: Vestfold Hospital Trust, Kysthospitalet
Study officials:
name: Aage Indahl, Phd
role: STUDY_CHAIR
References:
Clinical trial NCT00488813: Study of Antibiotic Utilization Measures and Control of ESBLs in China
Official title: Association of Antibiotic Utilization Measures and Control of Extended-spectrum β-lactamases (ESBLs) in MICU1 and MICU2 at Buddhist Tzu Chi General Hospital.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: ICU Patient
Keywords: Tzh-Chi ESBL study
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-06-20
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A single-center, prospective, comparative, antibiotic intervention study for patients admitted to MICU1 and MICU2

Detailed description: 1. To determine the value of using β-lactamases inhibitors in reducing the cases of ESBL producing E. coli or K. pneumoniae colonization and infection after 12 months.
2. To compare the acquisition rates of ESBL producing E. coli or K. pneumoniae at MICU1 and MICU2 after 12 months

Eligibility criteria: Inclusion Criteria:

* All patients admitted or transferred to the ICU/burn units.
* Patients of either sex, 18 years of age or older.

Exclusion Criteria:

* Patient with hypersensitivity to penicillins, cephalosporins, and beta-lactamase inhibitors.

Primary outcomes:
measure: For both MICU1 and MICU2 (acquisition), all culture results will be collected and recorded, then analyzed to determine the ESBL acquisition rate and bacterial isolates (E. coli or K. pneumoniae).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Taiwan, medinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04711213: A Clinical Study to Assess the Efficacy and Safety of SED80 for Use in Cataract Surgery
Official title: A Phase 2 Clinical Study to Assess the Efficacy and Safety of SED80 for the Treatment of Inflammation and Pain Associated With Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cataract in Inflammatory Ocular Disorders
Lead sponsor: iDrop, Inc.
Sponsor class: INDUSTRY
First posted: 2021-01-15
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized to 2 active dosing groups and 2 corresponding dosing groups
Primary purpose: TREATMENT

Brief summary: Patients at least 40 years of age who are undergoing cataract surgery will be randomized to receive treatment with one of four groups of dexamethasone ophthalmic suspension or placebo eye drops to determine if the drops decrease inflammation and pain inside the eye and are safe after cataract surgery.

Detailed description: "Patients undergoing traditional cataract surgery routinely develop inflammation and pain. This study will evaluate 4 arms of either dexamethasone or placebo.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing traditional cataract surgery.

Exclusion Criteria:

* Patients with unusual ocular conditions.

Primary outcomes:
measure: Ocular inflammation
timeFrame: Day 8
Secondary outcomes:
measure: Ocular Pain
timeFrame: Day 8
Other outcomes:
Locations:
city: San Salvador
country: El Salvador
facility: Centre De. Oftalmologia
Study officials:
affiliation: President - Centre De. Oftalmolgia
name: Gabriel Casada, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04791813: Assessment of Maxillary Arch Depth and Width in a Group of Surgically Repaired Unilateral Cleft Lip and Palate Children Versus Normal Children .
Official title: Assessment of Maxillary Arch Depth and Width in a Group of Surgically Repaired Unilateral Cleft Lip and Palate Egyptian Children Versus Normal Children .A Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cleft Lip and Palate
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 38
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy Egyptian children aging from 9-12 years old

Brief summary: The aim of the present study is to determine the effect of surgically repaired UCLP on dental arch dimensions and the need for orthodontic intervention in comparison with other healthy children , the presence of dental anomalies and the best possible standards of care among this group of Egyptian children.

Detailed description: In arranging to distinguish and implement the best possible standards of care for UCLP children by the pediatric dental practitioner, evaluation of early treatment results after essential surgical repair of cleft lip and palate with respect to arch dimensions is fundamental. Although the dental arch dimensions for these children have been evaluated in previous studies , few examiners in Egypt handled this issue Due to racial contrasts in improvement of the dental arch and growth .The deficiency of data in Egypt tending to this insufficient assemble of children presents a gap that prevents the transport of fitting dental care to them. This is considered objective to fulfill this gap by spotting the most characteristics of dental arch dimensions in surgically repaired UCLP children and compares them with those of sound, coordinating, non-cleft.

Eligibility criteria: Inclusion Criteria:

* Cooperative Egyptian children aging from ( 9-12) years.
* Medically free children.
* Children whose families accepts to participate in this study.
* Children with surgically repaired UCLP .

Exclusion Criteria:

* Children with previous untreated dental trauma.
* Children with previous orthodontic treatment
* Children with upper respiratory disease
* Children having any systemic diseases
* Intellectual disabilities or syndromes
* Congenital anomalies other than UCLP were excluded from the study .

Primary outcomes:
measure: Inter canine maxillary arch width at the gingival level and 2. Inter molar maxillary arch Width at gingival level 3. Maxillary arch depth
timeFrame: Participants will be examined for once "day1"
Secondary outcomes:
measure: Percentage occurrence of dental abnormalities.
timeFrame: Participants will be examined for once " day 1"
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Hadir A Ali
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06298513: Autonomic and Metabolic Response to Cardiac Rehabilitation After Acute MI
Official title: Autonomic and Metabolic Response to Cardiac Rehabilitation After Acute Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Myocardial Infarction: Rehabilitation Phase
Keywords: myocardial infarction
cardiac rehabilitation
metabolomic
autonomic nervous ststem
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 25
Sex: MALE
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients meeting the eligibility criteria will be proposed to participate in the study

Brief summary: Ischemic heart disease remains the leading cause of death in the western world. The beneficial effects of cardiac rehabilitation on the evolution of ischemic heart disease are known, but the effects of rehabilitation on the metabolic processes of the patients are so far poorly understood. Metabolomics is the qualitative/quantitative analysis of the body's metabolic responses to pathophysiological stimuli or genetic alterations. Metabolic changes caused by physical activity have been demonstrated in obese and diabetic patients and in athletes. Aim of the study is to evaluate whether cardiac rehabilitation after a first myocardial infarction induces changes in the metabolic state of patients, and whether these changes may be related with changes in the usual risk factors (i.e. glyco-lipidic profile, natriuretic peptides, homocysteine).


Eligibility criteria: Inclusion Criteria:

* recent first acute myocardial infarction

Exclusion Criteria:

* severe diabetes

Primary outcomes:
measure: Changes in purine after rehabilitation
timeFrame: Baseline and after 6 weeks of rehabilitation
measure: Changes in histidine after rehabilitation
timeFrame: Baseline and after 6 weeks of rehabilitation
measure: Changes in galactose after rehabilitation
timeFrame: Baseline and after 6 weeks of rehabilitation
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Auxologico Italiano
Study officials:
References:
Clinical trial NCT04596436: Mortality in Free-fall Trauma Patients
Official title: Patterns of Injury and Mortality in Free-fall Trauma Patients: a Multi-center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Free Fall Trauma
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 350
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients aged more than 20 years after free falls in the emergency department of the National Taiwan University Hospital, and the affiliations, Hsin-Chu branch, and Yun-lin branch.

Brief summary: In this study, the investigators aimed to analyze the demographic characteristics, patterns of injury, and mortality after free fall in the emergency department of the National Taiwan University Hospital, and the affiliations, Hsin-Chu branch, and Yun-lin branch.

Detailed description: Falls from a height are the leading cause of accidental deaths. The mechanism of free-fall injury is abrupt vertical deceleration and the severity is dependent on the height, body weight, posture and contact area...etc. Most victims presented to the emergency department with major trauma, so initial evaluation and management are crucial for survival. The knowledge of the unique pattern of injuries helps clinicians to facilitate the diagnosis.

Eligibility criteria: Inclusion Criteria:

patients aged more than 20 years after free falls in the emergency department of the National Taiwan University Hospital, and the affiliations, Hsin-Chu branch, and Yun-lin branch.

Exclusion Criteria:

patients aged less than 20 years after free fall in the emergency department of the National Taiwan University Hospital, and the affiliations, Hsin-Chu branch, and Yun-lin branch.

Primary outcomes:
measure: mortality after free falls
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Wan-Ching Lien
Study officials:
affiliation: NTUH
name: Wan-Ching Lien
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05453136: Phase III Study of TS-142 in Patients with Insomnia
Official title: A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 3 Study of TS-142 in Patients with Insomnia Disorder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Patients with Insomnia
Lead sponsor: Taisho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-07-12
Enrollment: 1155
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 is a randomized, double-blind, multi-center, placebo-controlled, parallel-group confirmatory study in patients with insomnia.


Eligibility criteria: Inclusion Criteria:

1. Japanese male and female who are aged 18 years or older at the time of informed consent
2. Outpatients
3. Patients falling under the category of insomnia disorder according to the diagnostic criteria in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)

Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

1. Patients falling under the category of any disorders other than insomnia disorder among sleep-wake disorders according to the diagnostic criteria in DSM-5
2. Patients with psychiatric disorders such as depression, schizophrenia, and anxiety
3. Patients with difficulty sleeping due to medical problems such as pain, pruritus, hot flush, nocturia (\> 3 times per night), heart disease, bronchial asthma, reflux esophagitis, endocrine disease, and periodic limb movement disorder

Other protocol defined exclusion criteria could apply.

Primary outcomes:
measure: Difference of subjective sleep latency (sSL) between TS-142 and placebo in mean change from baseline
timeFrame: Baseline and Week 2
Secondary outcomes:
measure: Difference of subjective sleep efficacy (sSE) between TS-142 and placebo in mean change from baseline
timeFrame: Baseline and Week 2
measure: Difference of sTST between TS-142 and placebo in mean change from baseline
timeFrame: Baseline and Week 2
measure: Difference of subjective wake time after sleep onset (sWASO) between TS-142 and placebo in mean change from baseline
timeFrame: Baseline and Week 2
measure: Difference of subjective number of awakenings (sNAW) between TS-142 and placebo in mean change from baseline
timeFrame: Baseline and Week 2
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Taisho Pharmaceutical Co., Ltd selected site
Study officials:
affiliation: Taisho Pharmaceutical Co., Ltd.
name: Taisho Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01246336: Exploratory Study Using Nanotechnology to Detect Biomarkers of Parkinson's Disease From Exhaled Breath
Official title: Exploratory Study to Detect Volatile Biomarkers of Idiopathic Parkinson's Disease and Parkinsonism From Exhaled Breath Using a Nanomedical Artificial Olfactory System.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Parkinsonism
Keywords: Parkinson's disease, Parkinsonism
Biomarkers
Exhaled breath
Nanothechnology
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
Collaborators: name: Technion, Israel Institute of Technology
First posted: 2010-11-23
Enrollment: 41
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with Idiopathic Parkinson's disease and Parkinsonism will be included.

Brief summary: Parkinson's disease is diagnosed clinically, because biomarkers that may help in diagnosis and differential diagnosis are not yet available. Exhaled breath testing may yield a "breath-print" that can be used to distinguish healthy and diseased states.


Eligibility criteria: Inclusion Criteria:

* Patients with Parkinsonism

Exclusion Criteria:

* Severe dementia

Primary outcomes:
measure: Nanosensory detection
timeFrame: immediate
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rambam Health Care Campus
name: Ilana Schlesinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02767336: Project BLOOM Regulatory Clinical Evaluation - System Accuracy, User Performance and System Use Evaluation
Official title: Project Bloom Regulatory Clinical Evaluation - System Accuracy, User Performance, System Use, Instructions for Use and Marketing Claims Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: LifeScan
Sponsor class: INDUSTRY
Collaborators: name: Bio-Kinetic Europe, Ltd.
First posted: 2016-05-10
Enrollment: 174
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Clinical Evaluation including System Accuracy, User Performance, System Use, Instructions for Use and Marketing Claims Evaluation.


Eligibility criteria: Summary of Inclusion Criteria:

* Able to voluntarily provide written informed consent to participate in the study.
* User Performance Accuracy Testing Only: Self-Monitoring - Subject is currently performing unassisted self-monitoring of blood glucose.
* For subjects participating in the In Vivo Glucose adjustment procedure age range is 18 - 45.

Summary of Exclusion Criteria:

* Female subjects who are pregnant or lactating.
* Subjects who, in the opinion of the Investigator, are unsuitable for participation in the study.
* User Performance Accuracy Testing Only -Prior involvement with the investigational BGMS being used in this study.

Primary outcomes:
measure: User Performance (UP) evaluation measured by blood glucose level (mg/dl) of BGMS vs reference instrument.
timeFrame: Up to 1 hour
measure: System Accuracy (SA) evaluation measured by blood glucose level(mg/dl) of BGMSs vs reference instrument.
timeFrame: Up to 1 hour
measure: System Use Evaluation questionnaire.
timeFrame: Up to 15 minutes
measure: Instructions for Use Evaluation questionnaire.
timeFrame: Up to 6 days.
measure: Marketing Claims Evaluation questionnaire.
timeFrame: Up to 6 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: BioKinetic Europe Ltd
state: Antrim
city: Birmingham
country: United Kingdom
facility: Diabetes Centre, Heartlands Hospital
city: Edinburgh
country: United Kingdom
facility: NHS Lothian
city: Inverness
country: United Kingdom
facility: Highland Diabetes Institute
Study officials:
affiliation: LifeScan Scotland Ltd
name: Lorna Stewart
role: STUDY_DIRECTOR
References: