louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04959422: Assuring Ophthalmologic Follow up
Official title: Assuring Ophthalmologic Follow up for Children Referred Following Instrument-based Vision Screening in a Pediatric Clinic: Effect of Immediate Referral Scheduling and Tracking
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Vision Screening
Amblyopia
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2021-07-13
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this study is to quantify the improvement in completed ophthalmology referrals and quantify the number of children identified and treated for amblyopia or pre amblyopic strabismus resulting from the implementation of a new referral and tracking system.

Detailed description: Children who fail instrument vision screens at Dartmouth Hitchcock (D-H) Community Group Practice (CGP) Pediatric Clinics will be scheduled at a community vision specialist office before departure from the Pediatric clinic. If the patient does not attend the appointment (a no show) at the vision specialist office , this will be tracked and the patient will be rescheduled.

Eligibility criteria: Inclusion Criteria:

* All pediatrics patients without pre-existing vision problems undergoing instrument vision screening at DH Pediatric CGP Clinics in at ages 2,3,4,5, and 6 years of age.

Exclusion Criteria:

* All pediatric patients with pre-existing eye problems that would cause them to be excluded from the study.
* All patients of parents who choose to go to an eyecare provider other than the one participating in the study (as we would be unable to make appointments or track appointments).
* All patients of parents who refuse to make an appointment

Primary outcomes:
measure: Number of children who complete vision evaluation
timeFrame: Approximately 1 year
Secondary outcomes:
measure: Number of children with amblyopia or pre amblyopic strabismus identified and treated
timeFrame: Approximately 1 year
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Darmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Andrew J Schuman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00347022: A Clinical Study of Xenetix 300 in Multislice Computed Tomography (CT) Pediatric Indications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diagnostic Imaging
Keywords: Multislice computed tomography (MSCT)indications
Lead sponsor: Guerbet
Sponsor class: INDUSTRY
First posted: 2006-07-04
Enrollment: 145
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This is a clinical study of Xenetix 300 in Multislice Computed Tomography (MSCT) in pediatric indications.


Eligibility criteria: Inclusion Criteria:

* Child aged 1 year or above and 16 years or under
* Patients with normal renal function (creatinine clearance \> 60 ml/min/1.73 m2)
* Patient requiring MSCT with contrast medium injection for diagnosis
* Patient who has a blood sample planned in the 24 hours preceding the MSCT scan
* Female patient with childbearing potential must have effective contraception (contraceptive pill or intrauterine device), be surgically sterilized or blood beta human chorionic gonadotropin (ßHCG) will be tested prior to product injection.
* Parent(s) of the patient (and child with sufficient intellectual maturity) provided his/her/their written informed consent for their child to participate in the trial.
* Patient with national health insurance

Exclusion Criteria:

* Patients who have received diuretic or biguanide treatment during the 48 hours preceding the MSCT scan.
* Patient with known allergy to iodinated contrast agent.
* Patient treated with nephrotoxic drugs within one week before first blood sample
* Patients planned to either undergo surgery or receive chemotherapy within 72 hours post injection (ie: before the blood test 72 hours post injection)
* Patient received or planned to receive an iodinated contrast agent during 48 hours preceding the MSCT scan.
* Breast feeding patient.
* Pregnant patient.
* Patient already included in this trial
* Patient included in another clinical trial involving an investigational drug.
* Patients whose degree of cooperation is incompatible with carrying out the study

Primary outcomes:
measure: Creatinine Clearance
timeFrame: between 48h before the contrast medium administration and 72h +/-12h after contrast medium administration
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: CHU Charles Nicolle
Study officials:
affiliation: Guerbet
name: Corinne Dubourdieu, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02520622: Digital vs. Printed Photographs: Impact on Skin Self-Examinations
Official title: Evaluation of the Impact of Using Digital Photographs on a Mobile Device Versus Printed Photographs on Patient Conducted Skin Exams
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Melanoma
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary aim is to determine the impact of using digital photographs on a mobile device versus printed photographs on skin self-examination rates. The ease-of-use and overall satisfaction with the two exam modalities will be evaluated. Secondarily, the impact on melanoma thickness at detection, melanoma detection, biopsy, and office visit rates will be evaluated. The study involves patients in the Pigmented Lesion Clinic that have received total body photography for skin monitoring.


Eligibility criteria: Inclusion Criteria:

* Patients presenting to the Penn Dermatology Pigmented Lesion Clinic who have a mobile device for personal use that either:
* (1) already have total body photography images, have a compact disc (CD) of digital versions of these images, and who do NOT already conduct proper monthly skin exams at home, and
* (2) patients that are having new images taken

Exclusion Criteria:

* Patients that are children or adolescents
* Patients that are court-ordered to attend residential alcohol or other drug treatment facilities and therefore considered prisoners
* Patients that are incompetent to provide informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization

Primary outcomes:
measure: Skin self-examination rates
timeFrame: 6 months
Secondary outcomes:
measure: Features important to a skin self-examination tool
timeFrame: 6 months
measure: Melanoma thickness at detection
timeFrame: 6 months
measure: Office visit rates
timeFrame: 6 months
measure: Biopsy rates
timeFrame: 6 months
measure: Melanoma detection rates
timeFrame: 6 months
measure: Study/technology implementation
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
citation: Marek AJ, Chu EY, Ming ME, Khan ZA, Kovarik CL. Piloting the Use of Smartphones, Reminders, and Accountability Partners to Promote Skin Self-Examinations in Patients with Total Body Photography: A Randomized Controlled Trial. Am J Clin Dermatol. 2018 Oct;19(5):779-785. doi: 10.1007/s40257-018-0372-7.
Clinical trial NCT06691022: Evaluation of the Effects of Passive Smoking and Parental Stress on Challenging Behaviors in Mentally Retarded Children With Urine Cotinine Levels
Official title: Evaluation of the Effects of Passive Smoking and Parental Stress on Challenging Behaviors in Mentally Retarded Children With Urine Cotinine Levels
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Smoking Behavior
Special Needs Child
Keywords: smoking
Child's Challenging Behaviour
parents
stres
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2024-11-15
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: special needs child

Brief summary: This research was planned to determine the effect of environmental cigarette smoke exposure and parenting stress level on the severity of challenging behaviors in mentally disabled children

Detailed description: This research was planned to determine the effect of environmental cigarette smoke exposure and parenting stress level on the severity of challenging behaviors in mentally disabled children

Eligibility criteria: Inclusion Criteria:

* Children aged 5-10 with mental disabilities
* Parents' ability to speak and understand Turkish
* Parents' willingness to participate in the study

Exclusion Criteria:

Children who do not match the age group and do not meet the inclusion criteria

Primary outcomes:
measure: The Child's Challenging Behaviour Scale 2 (CCBS-2)
timeFrame: 1 years
measure: parent stress scaleparent stress scale parent stress scale Parent's Stress Scale
timeFrame: 1 years
measure: cotinin in urine
timeFrame: 1 years
measure: sociodemographic questionnaire
timeFrame: 1 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: TURKEY
Study officials:
References:
Clinical trial NCT02857322: Effectiveness Accompaniment Perioperative Patients With Psychiatric Illness on the Lives Perioperative
Official title: Effectiveness Accompaniment Perioperative Patients With Psychiatric Illness on the Lives Perioperative
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychiatric Disorders
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-05
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The experimental strategy is to develop a specific device about the anesthetic and surgical acts for a subject with a documented psychiatric condition and to benefit from surgery. This device is based on 3 stages: pre-operative phase, Phase perioperative and postoperative phase. A nurse anesthetist will come into contact with the subject the day before surgery. This contact will be concomitant with the pre-anesthesia visit. She explained about the general organization of the arrival in the operating room. The interview will be a minimum of 15 minutes and beyond if necessary. This will be accompanying this the next day in the operating room in order to optimize its hospitality and installing the block, guide the subject through all the steps before falling asleep. Finally, even accompanying will be present upon awakening the subject in the recovery room.


Eligibility criteria: Inclusion Criteria:

* adult subject;
* Subject with chronic mental illness defined by ICD-10 classification \[ICD-10, 1992\], corresponding to psychoses say no emotional or affective psychoses say;
* Subject to which mental pathology is evolving for more than 6 months;
* Topic targeted for elective surgery;
* Topic judged capable of performing a self-administered questionnaire;

Exclusion Criteria:

* minor, pregnant or nursing women, about not being affiliated to the social security scheme, subject under guardianship;
* Subject with a mental illness do not belong to sections of ICD-10 contained in "inclusion criteria";
* Subject to benefit from surgery as part of the emergency;

Primary outcomes:
measure: experiences of the perioperative period
timeFrame: second day
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Urielle DESALBRES
role: STUDY_DIRECTOR
References:
Clinical trial NCT00111722: Study to Test a Marketed Drug in the Treatment of Menstrual Migraine (0462-072)
Official title: A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo Controlled Study to Evaluate the Efficacy and Tolerability of Rizatriptan 10 mg Tablets for the Treatment of Menstrual Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2005-05-25
Enrollment: 393
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the effectiveness of a marketed drug in the treatment of a menstrual migraine attack.


Eligibility criteria: Inclusion Criteria:

* Female patient at least 18 years old
* Patient has menses approximately monthly
* Patient has at least a 6 month history of migraine and at least a 6 month history of menstrual migraine

Exclusion Criteria:

* Pregnant and/or nursing mother
* Cardiovascular disease
* Uncontrolled hypertension

Primary outcomes:
measure: Percentage of patients with 2 hour pain relief: 4-point headache severity scale as recorded in patient diary
Secondary outcomes:
measure: Percentage of patients with 24-hr sustained pain relief: headache severity between 2 and 24 hrs post dose recorded in patient diary
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Mannix LK, Loder E, Nett R, Mueller L, Rodgers A, Hustad CM, Ramsey KE, Skobieranda F. Rizatriptan for the acute treatment of ICHD-II proposed menstrual migraine: two prospective, randomized, placebo-controlled, double-blind studies. Cephalalgia. 2007 May;27(5):414-21. doi: 10.1111/j.1468-2982.2007.01313.x.
citation: Nett R, Mannix LK, Mueller L, Rodgers A, Hustad CM, Skobieranda F, Ramsey KE. Rizatriptan efficacy in ICHD-II pure menstrual migraine and menstrually related migraine. Headache. 2008 Sep;48(8):1194-201. doi: 10.1111/j.1526-4610.2008.01093.x. Epub 2008 Apr 14.
Clinical trial NCT01432522: A Study for Absorption of Intranasal Epinephrine Compared to Conventional Intramuscular Epinephrine
Official title: Comparison of Absorption of Epinephrine Into the Circulation After Epinephrine Intranasal Spray Administration and After Intramuscular Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anaphylaxis
Keywords: Intranasal epinephrine
Plasma epinephrine level
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
Collaborators: name: Mahidol University
First posted: 2011-09-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a preliminary report of pharmacokinetic data of epinephrine administered via intranasal route (IN) comparing with intramuscular (IM) route in healthy adult volunteers.

Detailed description: Patients are reluctant to use Epipen® on emergency basis, perhaps because of improperly training, hesitancy and fear of needle. Other route of administration of epinephrine (EPI) may be more benefit such as intranasal route.

Eligibility criteria: Inclusion Criteria:

1. Healthy subjects
2. 18-30 years-old

Exclusion Criteria:

1. Pregnancy
2. Subjected who use current medication that interfere with result of plasma epinephrine level such as pseudoephedrine

Primary outcomes:
measure: Composite of Pharmacokinetics of epinephrine
timeFrame: predose, 5 , 10, 15, 20, 30, 45, 60, 90, 120, 180 minutes post-dose
Secondary outcomes:
measure: Numbers of participants with adverse events as a measure of safety and tolerability
timeFrame: 1 year
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Facaulty of Medicine, Siriraj Hospital
Study officials:
affiliation: Siriraj medical school, Mahidol Univrsity
name: Pakit Vichyanond, MD.
role: STUDY_DIRECTOR
References:
citation: Simons FE, Gu X, Simons KJ. Epinephrine absorption in adults: intramuscular versus subcutaneous injection. J Allergy Clin Immunol. 2001 Nov;108(5):871-3. doi: 10.1067/mai.2001.119409.
citation: Rawas-Qalaji MM, Simons FE, Simons KJ. Sublingual epinephrine tablets versus intramuscular injection of epinephrine: dose equivalence for potential treatment of anaphylaxis. J Allergy Clin Immunol. 2006 Feb;117(2):398-403. doi: 10.1016/j.jaci.2005.12.1310.
citation: Simons FE, Gu X, Johnston LM, Simons KJ. Can epinephrine inhalations be substituted for epinephrine injection in children at risk for systemic anaphylaxis? Pediatrics. 2000 Nov;106(5):1040-4. doi: 10.1542/peds.106.5.1040.
citation: Heilborn H, Hjemdahl P, Daleskog M, Adamsson U. Comparison of subcutaneous injection and high-dose inhalation of epinephrine--implications for self-treatment to prevent anaphylaxis. J Allergy Clin Immunol. 1986 Dec;78(6):1174-9. doi: 10.1016/0091-6749(86)90268-x.
Clinical trial NCT01091922: The Impact of Dietary Flavanols on the Gut Microflora
Official title: Prebiotic Evaluation of Cocoa-derived Flavanols in Healthy Humans Using a Randomized, Double Blind, Crossover, Placebo-controlled Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intestinal Bacteria Growth
Keywords: flavonoids
flavanols
bacteria
Lead sponsor: University of Reading
Sponsor class: OTHER
First posted: 2010-03-24
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The primary propose of this study is to determine the impact of flavanol-rich cocoa on the growth of the human gut microbiota.

Detailed description: A randomised, placebo-controlled, double-blind, cross-over human intervention study will be conducted in 20 healthy human volunteers to test the impact of a high-flavanol containing meal on the growth of the large intestinal bacteria (microflora). The high flavanol test meal will contain 495 mg of flavanols and the low flavanol control will contain 23 mg of flavanols. The two intervention diets are otherwise matched for macro- and micronutrient content. Changes in the gut microbiota will be determined by measuring bacterial population levels in human faecal material using 16S rRNA targeted oligonucleotide probes and fluorescence in situ hybridization. A number of other biochemical and physiological measures will be recorded including blood glucose, lipoproteins, cytokine levels and blood pressure.

Eligibility criteria: Inclusion Criteria:

* a signed consent form
* age of 18-50 years inclusive
* BMI between 20-26

Exclusion Criteria:

* pregnant or lactating
* allergy to milk products
* sensitivity to alkaloids and/or caffeine
* gastrointestinal disorders (e.g., chronic constipation, diarrhoea, inflammatory bowel disease, -inflammatory bowel syndrome, or other chronic gastrointestinal complaints)
* diabetes mellitus
* hypertension (\>150/90 mm/Hg)
* anaemia and gall bladder problems
* not consuming probiotics, prebiotics, antibiotics or anti-inflammatory or blood lowering medication within a 2-month period prior to the study.

Primary outcomes:
measure: Faecal bacteria numbers using 16S rRNA targeted oligonucleotide probes analysis and fluorescence in situ hybridization
timeFrame: baseline and 4 weeks
Secondary outcomes:
measure: Blood pressure
timeFrame: Baseline, 4 weeks
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: University of Reading
state: Berkshire
Study officials:
affiliation: University of Reading
name: Jeremy Spencer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tzounis X, Rodriguez-Mateos A, Vulevic J, Gibson GR, Kwik-Uribe C, Spencer JP. Prebiotic evaluation of cocoa-derived flavanols in healthy humans by using a randomized, controlled, double-blind, crossover intervention study. Am J Clin Nutr. 2011 Jan;93(1):62-72. doi: 10.3945/ajcn.110.000075. Epub 2010 Nov 10.
Clinical trial NCT02390622: Biotherapy for MRSA Enterocolitis
Official title: Fecal Microbiota Transplantation Restores Dysbiosis in Patients With Methicillin Resistant Staphylococcus Aureus Enterocolitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Methicillin-Resistant Staphylococcus Aureus
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2015-03-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Methicillin-resistant Staphylococcus aureus (MRSA) is one of the major sources of nosocomial infection. Along with the widely application of antibiotics around perioperative period, MRSA infection is increasing by years.Fecal microbial transplantation (FMT),infusion of fecal preparation from a healthy donor into the GI tract of a patient is being proposed as a novel therapeutic approach to modulate diseases associated with pathological imbalances within the resident microbiota, termed dysbiosis.It has been used to treat intestinal disease such as inflammatory bowel diseases and Clostridium difficile infection, but no reports are available on its role in treating MRSA enteritis yet. vancomycin is the first choice to treat MRSA but can also lead to an increase in antibiotic resistant organisms such as vancomycin-resistant enterococci, methicillin-resistant Staphylococcus aureus and transfer of antibiotic resistance genes among the microbial community. So FMT seems a more harmless and reasonable measure to treat similar diseases.

Detailed description: Five cases from July, 2013 to February, 2014 were collected in Jinling hospital.They developed unexplained high fever, bloating, nausea, vomit, a high stoma output or diarrhea in the color of yellow-green with copious amounts of mucus leading to dehydration and tachycardia after short time of operation (2-4d).We got the etiology diagnosis from all the patients' gastric juice cultures which revealed MRSA.Vancocin cp had a dissatisfied effect,so FMT was supplied for treating MRSA.All the patients had a decreased intestinal flora species before FMT and the content of staphylococcus aureus almost reached half of total intestinal flora . Patients' gut bacteria after FMT gradually agree with the donors' reflected the alleviative symptoms.

Eligibility criteria: Inclusion Criteria:

1.18-70 years old 2.patients diagnosed as MRSA enterocolitis

Exclusion Criteria:

1.infectious diarrhea caused by other pathogenic bacteria

Primary outcomes:
measure: Species diversity in fecal
timeFrame: one month after FMT
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of General Surgery, Jinling hosptal,Medical School of Nanjing University
state: Jiangsu
Study officials:
affiliation: Institute of General Surgery, Jinling Hospital, Medical School of Nanjing University，
name: Ning Li, MD
role: STUDY_DIRECTOR
References: