louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02086110: Effect of Milk Oligosaccharides and Bifidobacteria on the Intestinal Microflora of Children With Autism
Official title: A Pilot Study Examining Microbiota Composition in Children With Autism and Gastrointestinal Symptoms After Use of Bifidobacterium Infantis and Milk Oligosaccharides
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Keywords: probiotic
prebiotic
autism
oligosaccharides
Bifidobacterium infantis
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2014-03-13
Enrollment: 11
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the tolerability of dietary supplements and if these supplements can promote a healthy bacterial environment in the intestines of children with autism spectrum disorders and gastrointestinal complaints.

Detailed description: This study investigates the feasibility, tolerability, and effects of a dietary supplement on the intestinal flora of children with autism spectrum disorders. This study is divided into two parts, each five weeks long, with a two week break in between. During one part of the study, a prebiotic (milk oligosaccharides from bovine colostrum) will be given. During the other part of the study, the synbiotic composed of the prebiotic and probiotic (bifidobacterium infantis) will be given. Stool will be analyzed at the end of each study arm to determine content of bifidobacteria.

On May 8, 2018, we updated the study start and completion dates to the actual (instead of anticipated) dates.

On May 30-31, 2019, we updated the study results section.

Eligibility criteria: Inclusion Criteria:

* Autism
* Diarrhea and/or constipation

Exclusion Criteria:

* Milk protein or other documented food allergy
* Lactose intolerance
* Compromised Immunity
* GI conditions (inflammatory bowel disease, celiac disease, short gut, etc.)
* Systemic steroid, antifungal, or antibiotic use within a month of starting the study
* Failure to thrive
* Medically prescribed diets or supplements (including probiotic use within the past month).
* Vegetarian or dairy restricted diet
* Other medical conditions (seizures, genetic disorders, liver/pancreatic disease, cystic fibrosis, etc.)
* Medications that interfere or alter intestinal motility or microbiota composition.
* Full scale intelligence quotient (IQ) \<40

Primary outcomes:
measure: Stool Microbiota Composition Change During Prebiotic Only Treatment
timeFrame: Five weeks
measure: Stool Microbiota Composition Change During Synbiotic Treatment
timeFrame: Five weeks
Secondary outcomes:
measure: Serum Immune Profile Change During Prebiotic Only Treatment
timeFrame: Five weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis MIND Institute
state: California
Study officials:
affiliation: UC Davis MIND Institute
name: Kathleen Angkustsiri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01477710: Ability of Caregivers to Provide Ventilation With the SAVe Resuscitator in a Model
Official title: Ability of Caregivers to Provide Ventilation With the SAVe Resuscitator in a Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-hospital Ventilation
Keywords: Mechanical ventilation
Tidal volume
Respiratory rate
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: United States Air Force
First posted: 2011-11-22
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will compare three methods of delivering mechanical ventilation using a test lung. Ventilation will be delivered using (1) a mask held in place by a caregiver, (2) a mask strapped to the model using a securing device, and (3) a supraglottic airway. Endpoints include respiratory rate and tidal volume.

Detailed description: To evaluate the ability of caregivers to provide adequate ventilation (respiratory rate and tidal volume) in a model of the upper airway and lungs. Ventilation will be delivered while the mask is held in place by the caregiver, with the mask strapped to the model using the securing device provided with the ventilator, and following placement of a supraglottic airway.

Eligibility criteria: Inclusion Criteria:

* Voluntary participation
* Nurse, respiratory therapist, or physician
* involved in the care of patients requiring ventilation and airway management

Exclusion Criteria:

-

Primary outcomes:
measure: Tidal Volume
timeFrame: 10 minutes per technique, for a total of 30 minutes per participant
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University Hospital
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Richard D Branson, MSc RRT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00705510: Efficacy of 0.05 % Cyclosporine Ophthalmic Emulsion Compare With Tear in Meibomian Gland Dysfunction
Official title: Efficacy of 0.05 % Cyclosporine Ophthalmic Emulsion Compare With Tear in Meibomian Gland Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Meibomian Gland Dysfunction
Keywords: Cyclosporine
Unstable tear film
Meibomian gland
Meibomian gland dysfunction
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2008-06-26
Enrollment: 70
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: To evaluate the efficacy of 0.05% cyclosporine ophthalmic emulsion (Restasis® , Allergan) versus an artificial tears alone in patients with meibomian gland dysfunction that have abnormal tear quality and quantity by subjective symptoms and signs including tear breakup time

Detailed description: Meibomian gland dysfunction patients will divide into 2 groups. One group will have 0.05% cyclosporine opthalmic emulsion and the other will have non-preservative artificial tear twice daily, compare the result in 3 months.

Eligibility criteria: Inclusion Criteria:

* Males or females, of legal age of consent
* Patient has a diagnosis of meibomian gland dysfunction with at least 1 symptom as the following; ocular burning, ocular discomfort, and grittiness
* Had a slit-lamp diagnosis of meibomian gland dysfunction based on the presence of one of the following

  * meibomian gland inflammation by lid margin or tarsal erythema, bulbar conjunctiva hyperemia, telangiectasia or thickening irregularity of the eyelid margins
  * meibomian gland orifice inclusion (plugging) or abnormal of secretion
* Non-invasive tear break up time (NTBUT) with Tear scope Plus(Keeler, Windsor, UK) ≤ 8 seconds
* Ability to follow study instruction and likely to complete all required visits

Exclusion Criteria:

* Age \< 18 years old
* Patients with severe ocular disease from Steven Johnson syndrome burn, limbal deficiency
* Patients used cyclosporine within past 1 year
* Patients used oral cyclosporine or anticholinergic drug within past 2 months
* Patients with HIV or autoimmune disease
* Patients with active ocular infections and patients with a history of herpes keratitis
* Patients with known or suspected hypersensitivity to any of the ingredients in the formula (cyclosporine, glycerin, castor oil, polysorbate 80, carbomer 1342)
* Female patients are pregnant or nursing
* Patients who wear contact lenses

Primary outcomes:
measure: NTBUT
timeFrame: 0,1,2,3 month
Secondary outcomes:
measure: OSDI score, FTBUT, lid inflammation, meibomian gland secretion and expressibility, bulbar and tarsal conjunctival injection,fluorescein staining, rose bengal staining
timeFrame: 0,1,2,3 month
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Ophthalmology; Siriraj Hospital
Study officials:
affiliation: Department of Ophthalmology, Siriraj H, Mahidol U
name: Pinnita Prabhasawat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06868810: Comparison of 5% Nacl and 10% NaHCO3 As Contrast Agents for Lung Perfusion with EIT
Official title: Comparison of 5% Sodium Bicarbonate and 10% Sodium Chloride As Contrast Agents for Lung Perfusion with Electrical Impedance Tomography: a Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ARDS (Acute Respiratory Distress Syndrome)
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Electrical impedance tomography (EIT) has enabled the bedside monitoring of lung perfusion measurement through the indicator-based contrast method. Currently, hypertonic sodium chloride is the most commonly used contrast agent for lung perfusion evaluation by EIT. However, concerns may be raised regarding the potential risks of hyperchloremia and possible acute kidney injury associated with the use of hypertonic NaCl. Recently, two experimental studies found sodium bicarbonate (NaHCO3) might be an alternative to hypertonic sodium chloride in lung perfusion assessment by EIT. However, whether NaHCO3 results in acceptable bias is unknown in critically ill patients. This clinical study aimed to further investigate the correlation and agreement of lung perfusion and Ventilation/perfusion (V/Q) match by EIT contrast method between two contrast indicators (5%NaHCO3 vs. 10% NaCl) in critically ill patients with respiratory failure.


Eligibility criteria: Inclusion Criteria:

* In need of lung perfusion assessment due to clinical condition
* With central venous catheter

Exclusion Criteria:

* contraindications to the use of EIT (automatic implantable cardioverter defibrillator, chest wounds limiting electrode belt placement, implantable pumps, etc.)
* severe hyperchloremia (\>155 mmol/L)
* unable to tolerate breath-hold maneuver
* pregnant or breastfeeding females

Primary outcomes:
measure: lung perfusion distribution in ROI
timeFrame: Offline analysis, immediately after the saline injection procedure
Secondary outcomes:
measure: V/Q match in ROI
timeFrame: Offline analysis, immediately after the saline injection procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01892410: Patch Test Skin Irritation/Sensitization of Cetaphil Restoraderm Skin Restoring Body Wash
Official title: 100 Human Subject Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation (Semi-Occlusive Patch)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Irritation
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2013-07-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Determine if Cetaphil Restoraderm Skin Restoring Body Wash proves to be a contact sensitizer or irritant in certain individuals.


Eligibility criteria: Inclusion Criteria:

* Not currently under a doctor's care
* Free of dermatological or systemic disorder which would interfere with the results
* Free of any acute or chronic disease
* Will complete a preliminary medical history form and are in general good health
* Can read, understand, and sign informed consent

Exclusion Criteria:

* Under 18 years old
* Currently under doctor's care
* Currently taking any medication
* History of acute or chronic disease
* Diagnosed with chronic skin allergies
* Pregnant or lactating

Primary outcomes:
measure: Area of irritation measured to determine sensitivity
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New City
country: United States
facility: AMA Laboratories, Inc.
state: New York
Study officials:
affiliation: AMA Laboratories
name: Mayya Tastene, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02659410: Impact of Thermal Stress on Pulmonary Absorption and Toxicokinetics of 3 Organic Solvents
Official title: Studying the Impact of Thermal Stress (Heat) Representative of Occupational Settings on Pulmonary Absorption and Toxicokinetics of 3 Organic Solvents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heat
Keywords: Physiologically based pharmacokinetic modeling
Organic solvents
Lead sponsor: Université de Montréal
Sponsor class: OTHER
Collaborators: name: Institut de Recherche Robert-Sauvé en Santé et en Sécurité du Travail
First posted: 2016-01-20
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: In Quebec, thousands of workers are concomitantly exposed to heat and chemical compounds. Exposure to heat induces physiological responses that help maintaining a stable body temperature. Those changes can affect organ functions implicated in absorption and metabolism. According to literature, those changes could lead to increased concentrations of chemical compounds in the body and their toxicity. Therefore, the aim of this study is to evaluate the pulmonary absorption and toxicokinetics of 3 organic solvents in heat stress conditions in volunteers exposed in a inhalation chamber. Results will then be used to develop PBPK models that will allow to predict organic solvent kinetics when coexposed with heat.


Eligibility criteria: Inclusion Criteria:

* Body mass index between 18,5 et 25 kg/m3

Exclusion Criteria:

* Smoking
* Respiratory, cardiovascular and neurological problems
* History of exposure to solvents
* Chronic medication
* Abusive and/or chronic alcohol consumption
* Alcohol consumption 24h before or 18h following exposure

Primary outcomes:
measure: Respiratory rate
timeFrame: 4hour
measure: Cardiac frequency
timeFrame: 4hour
measure: Minute ventilation
timeFrame: 4hour
measure: Tidal volume
timeFrame: 4hour
measure: Solvent in blood
timeFrame: 4,5hour
measure: Solvent or metabolite in urine
timeFrame: 18hour
measure: Solvent in exhaled air
timeFrame: 6hour
Secondary outcomes:
measure: Oxygen consumption
timeFrame: 4hour
measure: Carbonic dioxide production
timeFrame: 4hour
measure: Body temperature
timeFrame: 4hour
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Université de Montréal
state: Quebec
Study officials:
affiliation: Université de Montréal
name: Sami Haddad, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT01085110: Persistent Pain After Laparoscopic Inguinal Hernia Repair
Official title: Neurophysiological Characterization of Persistent Pain After Laparoscopic Inguinal Hernia Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Neuropathic Pain
Postherniotomy Pain
Keywords: Groin hernia
Chronic pain
QST
Quantitative sensory testing
Persistent postoperative pain
Laparoscopic inguinal herniotomy
Postherniotomy Pain after laparoscopic inguinal herniotomy
laparoscopic inguinal hernia repair
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Innovative Medicines Initiative
First posted: 2010-03-11
Enrollment: 11
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with persistent pain after laparoscpic inguinal hernia repair

Brief summary: Describe and characterizes laparoscopic postherniotomy patients with persistent moderate/severe pain affecting every day activities - including detailed quantitative sensory assessment


Eligibility criteria: Inclusion Criteria:

* Male patients \> 18 yrs
* No sign of hernia recurrence
* Chronic groin pain lasting more than 3 months
* Moderate/severe pain related impairment of everyday activities

Exclusion Criteria:

* Other causes of persistent pain in groin region (hip, other surgical procedures)
* Drug or alcohol abuse
* Conflicting neurological disorders

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Section of Surgical Pathophysiology, Rigshospitalet, Copenhagen University
Study officials:
affiliation: Section of Surgical Pathophysiology, Rigshospitalet
name: Gitte Linderoth, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Section of Surgical Pathophysiology, Rigshospitalet
name: Henrik Kehlet, MD, Proff
role: STUDY_DIRECTOR
References:
Clinical trial NCT01356810: Prophylactic Environmental Management of Delirium
Official title: Manejo Ambiental Profilactico Del Delirium Intrahospitalario
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium
Falls
Keywords: Delirium
Primary Prevention
Elderly
Lead sponsor: Universidad de Valparaiso
Sponsor class: OTHER
First posted: 2011-05-20
Enrollment: 287
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Delirium is a complex neuropsychiatric syndrome with an acute onset and fluctuating course which is presented in 15 to 20% of patients admitted to general wards. It is a potentially life - threatening complication which can be prevented. It is the objective of this randomized controlled trial to evaluate whether a multicomponent environmental intervention could reduce the incidence of delirium in a general medical ward.

Detailed description: A total of 287 patients 65 years of age or older who had been admitted to a general medicine ward and who were at risk of delirium were studied. Eligible patients were randomized to a multicomponent environmental intervention or standard care. Both groups were well balanced in patients characteristics and followed during the full hospital stay by a group trained in the application of the confusion assessment method to detect incident delirium.

Eligibility criteria: Inclusion Criteria:

* Above 65 years of age and one of the following:
* Age above 70 years.
* Alcoholism
* Cognitive deficit (Mini mental state examination \<24 points)
* Metabolic disturbance (Hyponatremia, Hypernatremia, Hyperkalemia, Hypokalemia Hyperglycemia or Hypoglycemia)

Exclusion Criteria:

* Delirium at admission.
* Admittance to a ward other than general internal medicine.
* Lack of family support.
* Informed consent refusal.
* Hospitalization in a room with more than two beds.

Primary outcomes:
measure: Incidence of Delirium
timeFrame: Daily during the entire hospital stay (Average: 10 days, Maximum: 42 days)
Secondary outcomes:
measure: Incidence of Falls
timeFrame: Daily during the entire hospital stay (Average: 10 days, Maximum: 42 days
Other outcomes:
Locations:
city: Vina del Mar
country: Chile
facility: Hospital Naval Almirante Nef
state: Valparaiso
Study officials:
affiliation: Universidad de Valparaiso
name: Felipe T Martinez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02311010: Practical Use of Advagraf de Novo After Kidney Transplantation According to Recipient Genetic Polymorphism
Official title: Influence of Recipient Cytochrome P450 3A5 Polymorphism on the Metabolism of Prolonged Release Tacrolimus Administered de Novo After Renal Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Kidney Diseases
Keywords: transplant
immunosuppressive drug
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2014-12-08
Enrollment: 150
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To optimize the Advagraf (tacrolimus once a day) initial daily dose used in de novo after kidney transplantation in combination with MMF (or MPA) and corticosteroids (CS) regarding of the genetic Cyp 450 3A5 polymorphism of the recipient.

The study of the tacrolimus through level (ng/ml) determines if the therapeutic level is reached.


Eligibility criteria: Inclusion Criteria:

* First or second Kidney Transplantation from deceased or living donor

Exclusion Criteria:

* Donor age \< 5 years.
* Patients who require plasma exchange because of high immunological risk

Primary outcomes:
measure: Pharmacokinetics of tacrolimus
timeFrame: 1 year
Secondary outcomes:
measure: Kidney graft function
timeFrame: 1 year
Other outcomes:
measure: Administration strategy
timeFrame: first day
measure: New onset of diabetes after transplantation (NODAT)
timeFrame: 1 year
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint Luc Université Catholique de Louvain
Study officials:
References:
citation: De Meyer M, Haufroid V, Kanaan N, Darius T, Buemi A, De Pauw L, Eddour DC, Wallemacq P, Mourad M. Pharmacogenetic-based strategy using de novo tacrolimus once daily after kidney transplantation: prospective pilot study. Pharmacogenomics. 2016 Jun;17(9):1019-27. doi: 10.2217/pgs-2016-0005. Epub 2016 Jun 8.
Clinical trial NCT06295510: Observational Study of the Association Between Food Intake and Endometrial Polyps
Official title: A Cross-sectional Observational Study of the Association Between Food Intake and Endometrial Polyps
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diet Habit
Endometrial Polyp
Women
Keywords: Diet
Endometrial polyp
Women
Milk tea
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 150
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study period will include all patients who attended gynecological outpatient clinics between March 1, 2024 and May 1, 2024

Brief summary: There are currently no studies evaluating the association between diet and the incidence of endometrial polyps. We aim to evaluate the association to provide more recommendations for the early prevention of endometrial polyps.

Detailed description: The incidence of endometrial polyps is closely related to daily diet and living habits. Due to the excessive use of food additives, the content of some common dietary hormones exceeds the standard, causing irreversible effects on female growth and development.

The daily diet structure is closely related to women's health, and the enrichment of estrogen in common drinks may cause adverse effects such as premature puberty in women, abnormal thyroid function, and changes in uterine structure. Therefore, the researchers conducted a retrospective analysis of patients with endometrial polyps and normal women to compare the associations and differences between daily diet and disease.

Eligibility criteria: Inclusion Criteria:

* Consistent with the international clinical diagnosis of endometrial polyps.Can complete content recall alone.

Exclusion Criteria:

* No other mental diseases. Not associated with other major diseases, including tumors, immune system diseases

Primary outcomes:
measure: Hormonal dietary intake
timeFrame: Within the past 1 year
measure: Comparison of daily living habits
timeFrame: Within the past 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospital of Chengdu University of Traditional Chinese Medicine
name: Qinxiu Zhang
role: STUDY_DIRECTOR
References: