louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04433923: Aluminium Foil as an Adjuvant to Phototherapy for Pathological Unconjugated Hyperbilirubinaemia in Full Term Infants
Official title: Aluminium Foil as an Adjuvant to Phototherapy for Pathological Unconjugated Hyperbilirubinaemia in Full Term Infants: Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Jaundice
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-06-16
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Primary purpose: TREATMENT

Brief summary: prospective single center pilot randomized open label clinical trial, conducted at the Neonatal care unit of Mansoura University Children's To assess the efficacy and safety of aluminum foil use in combination with phototherapy compared with phototherapy alone for pathological unconjugated hyperbilirubinaemia in full term newborn We enrolled 234 infants in the study who fulfilled the inclusion criteria and were randomly assigned to treatment groups, either conventional phototherapy with aluminum foil or conventional phototherapy alone.


Eligibility criteria: Inclusion Criteria:

* Appropriate for gestational age full-term infants with pathological unconjugated hyperbilirubinaemia who are candidate for photo therapy according to American academy guidelines

Exclusion Criteria:

* Preterm infants, newborn infant with congenital malformations, conjugated hyperbilirubinamia, small for gestational age, in need of exchange transfusion, and skin abrasions or infections

Primary outcomes:
measure: Total serum bilirubin
timeFrame: 8 hours of treatment
measure: Total serum bilirubin
timeFrame: 24 hours of treatment
measure: Total serum bilirubin
timeFrame: 48 hours of treatment
Secondary outcomes:
measure: duration of photo therapy
timeFrame: average 48 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01679223: Incorporation of AlloMaxTM in Breast Reconstruction Ver8-15-12
Official title: Objective Evaluation of Collagen Deposition in AlloMaxTM Acellular Dermal Matrix in Breast Reconstruction Version 8-15-12
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: Breast reconstruction
Hydroxyproline concentration
neoangiogenesis
collagen deposition
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
First posted: 2012-09-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients (18 - 70 yrs) scheduled for immediate two stage breast reconstruction with AlloMaxTM are potential subjects for this study

Brief summary: The purpose of this study is to measure the level of AlloMax™ incorporation (cellular infiltration, collagen production, and neovascularization) in human breast reconstruction. The hypothesis is that the AlloMaxTM will have incorporation equivalent to adjacent breast capsule at the 3-4 month time point.


Eligibility criteria: Inclusion Criteria:

* Adult patients (18 - 70 yrs) who require reconstructive breast surgery with AlloMaxTM implants and agree to participate will be included in this study.

Exclusion Criteria:

* Patients who do not agree to be included in the study.

Primary outcomes:
measure: Hydroxyproline Concentration
timeFrame: 3-4 months
measure: Neoangiogenesis
timeFrame: 3-4 months
measure: Collagen I and III
timeFrame: 3-4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: University of Nevada School of Medicine
state: Nevada
Study officials:
affiliation: University of Nevada School of Medicine
name: Kayvan Taghipour-Khiabani, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nevada School of Medicine
name: William A Zamboni, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT05490823: Validation of a Smartphone App for Anemia Screening Among General Population
Official title: Validation of a Smartphone App for Anemia Screening Among General Population: A Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anemia
Keywords: Smartphone app
Artificial intelligence
Public health
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 3
Maximum age (years): 87
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The current standard for anemia screening, complete blood count, presents invasiveness, infrastructure requirements and high costs, leading to serious underestimation of anemia prevalence and insufficient care for anemia patients. Here, the investigators established and validated an artificial intelligence system to achieve automatic detection of anemia based on patient-sourced images of fingernails and conjunctivae. This system has been integrated into a smartphone app to be further validated through hospital-based and population-based clinical trials.


Eligibility criteria: Inclusion Criteria:

* Patients should be aware of the contents and signed for the informed consent.

Exclusion Criteria:

* Patients who underwent ophthalmic or fingernail surgery in the past 30 days

Primary outcomes:
measure: The proportion of accurate, mistaken and missed detection of this smartphone app.
timeFrame: 27 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT01401023: Pharmacokinetics and Safety of Tigecycline in the Treatment of Clostridium Difficile Associated Diarrhea (CDAD)
Official title: Pharmacokinetics and Safety of Tigecycline in the Treatment of Clostridium Difficile Associated Diarrhea (CDAD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diarrhea
Clostridium Difficile
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2011-07-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, non-comparative, interventional, observational pilot study of the safety and pharmacokinetics of intravenous (IV) tigecycline in conjunction with standard oral therapy in patients with known mild to severe confirmed Clostridium difficile associated diarrhea (CDAD).

Detailed description: The intervention is adding Tigecycline (standard doses) to standard oral therapy for CDAD. Patients will then be observed for clinical outcomes and relapse of CDAD.

Eligibility criteria: Inclusion Criteria:

* non pregnant adults (≥18 years old) with a diagnosis of mild to severe CDAD (initial or recurrent) by positive C. difficile toxin assay along with clinical symptoms (watery stools, fever, abdominal pain). Patients will receive a minimum of 3 days of tigecycline.

Exclusion Criteria:

* pregnant patients
* allergy to tetracycline (or tigecycline) antibiotics or patients with life-threatening illness.

Primary outcomes:
measure: Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile
timeFrame: day 3 of treatment
measure: Mean (SD) Minimun Inhibitory Concentration of Tigecycline of Clostridium Difficile Isolates
timeFrame: day 1 stool sample
measure: Mean (SD) Serum Tigecycline Concentration Level
timeFrame: day 3 of tigecycline therapy
measure: Mean (SD) Stool Tigecycline Concentration Level
timeFrame: day 3 of tigecycline therapy
measure: Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile
timeFrame: day 3 of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
city: Lansing
country: United States
facility: Sparrow Hosptial
state: Michigan
Study officials:
affiliation: Michigan State University
name: Gary Stein, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04742023: Post-operative Complications and Graft Survival With Conventional Versus Continuous Glucose Monitoring in Patients With Diabetes Mellitus Undergoing Renal Transplantation
Official title: Post-operative Complications and Graft Survival With Conventional Versus Continuous Glucose Monitoring in Patients With Diabetes Mellitus Undergoing Renal Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Diabetes Mellitus
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This will be a prospective, randomized, single-blinded controlled trial in which the investigators evaluate post-operative serum glucose control using conventional point-of-care glucose monitoring in the morning and before meals (standard of care) versus continuous glucose monitoring using the Medtronic Guardian™ Sensor 3 continuous glucose monitor. The investigators will compare the average daily glucose level in the post-operative period (through post-operative day five) between the two arms in patients with diabetic nephropathy immediately post-renal transplant. This will serve as a pilot study to in order to power a main study.


Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 18 years or older
4. Undergoing first-time renal transplantation
5. Have a pre-existing diagnosis of Type 2 diabetes mellitus

Exclusion Criteria:

1. Age less than 18 years
2. Use of insulin pump at time of transplant
3. Insulin infusion requirement during hospitalization
4. Pregnancy or lactation
5. Known allergic reaction to Guardian™ Sensor 3 or adhesives
6. History of hypoglycemia unawareness

Primary outcomes:
measure: Average Daily Glucose
timeFrame: Postoperative day 1 - 5
Secondary outcomes:
measure: Number of Hyperglycemic Episodes
timeFrame: Postoperative days 1-5
measure: Number of Hypoglycemic Episodes
timeFrame: Postoperative days 1-5
measure: Total Insulin Use
timeFrame: Postoperative days 1-5
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
Study officials:
References:
Clinical trial NCT00117923: Study With a Topical Gel to Treat Common Warts in Adults
Official title: A Three-Stage, Modified-Blind, Dose-Escalating Study to Assess Efficacy and Safety of Resiquimod Gel Applied 5 Times Per Week for 4 Weeks for the Treatment of Common Warts in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Warts
Keywords: Warts
Adults
Common Warts
Resiquimod
Lead sponsor: Graceway Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2005-07-11
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to evaluate the effectiveness in adults of four different strengths of resiquimod gel applied to common wart(s) five times a week for four weeks.

A second purpose is to evaluate the safety of the drug.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of common warts
* Two forms of birth control

Exclusion Criteria:

* Pregnant or breast feeding
* Other types of warts, ie. plantar
* Currently participating in another clinical study
* Chronic viral hepatitis B or C

Primary outcomes:
measure: Clearance of treated wart(s)
Secondary outcomes:
measure: Partial clearance of treated wart(s)
measure: Wart recurrence
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
Study officials:
References:
Clinical trial NCT04991623: Short-term Effects Kinesiology Tape on Sitting Postural Control in Moderate and Severe Cerebral Palsy
Official title: Short-term Effects Kinesiology Tape on Sitting Postural Control in Moderate and Severe Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Kinesiology Taping
Postural Control
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 12
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To analyze the short-term effect of kinesiology taping on sitting postural control in moderate and severe cerebral palsy


Eligibility criteria: Inclusion Criteria:

* age between 4 and 14 years
* diagnosis of motor and cognitive disability
* have prescribed physiotherapy treatment at school
* acquisition of autonomous sitting
* sign the consent informed

Exclusion Criteria:

* presentation of an allergic reaction to tape
* presentation of wounds in the area of application of the tape
* having received botulinum toxin treatment in the last 6 months

Primary outcomes:
measure: Posture and Postural Ability Scale - T0
timeFrame: pre-intervention
measure: Posture and Postural Ability Scale - T1
timeFrame: at 10 days
measure: Segmental Assessment of Trunk Control - T0
timeFrame: pre-intervention
measure: Segmental Assessment of Trunk Control - T1
timeFrame: at 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Toledo
country: Spain
facility: Javier Merino Andrés
Study officials:
affiliation: Researcher
name: Javier Merino Andrés, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06352723: Cenobamate in the Intensive Care Unit
Official title: Use of Cenobamate in the Intensive Care Unit for Acute Frequent Seizures and Status Epilepticus
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Epilepsy
Neurologic Disorder
Keywords: ICU
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm pilot study
Primary purpose: TREATMENT

Brief summary: The CENOBITE study will be conducted as a multi-center trial involving X leading centers from the Critical Care EEG Monitoring Consortium (CCEMRC). A total of 10 patients will be recruited over a period of one year, with each patient undergoing monitored treatment regimen. Each site will obtain its own approval from their institutional review board. Data will be shared through the MGB REDCap; raw EEG files will be shared through the MGB Dropbox and analyzed at the BWH.

Monitoring for the development of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome, a potential adverse reaction, will be a key aspect of the study. Regular assessments, including RegiSCAR scoring (a validated scoring system for DREeSS5), daily serum cenobamate level measurements, and comprehensive lab tests, will be conducted to ensure patient safety and the effective management of any adverse reactions such as DRESS syndrome.


Eligibility criteria: Inclusion Criteria:

* Age 18-70.
* Undergoing EEG monitoring.
* Acute frequent seizures (\>1/hour) or status epilepticus (\>5 min of consecutive seizures, or seizure burden \>20% within past 1 hour).
* Adjunctive conventional antiseizure medication indicated.

Exclusion Criteria:

* History of medication-related rash.
* On medication or device affecting enteral absorption (e.g., phenobarbital, pentobarbital).
* Counterindication to cenobamate as described in the prescribing information.

Primary outcomes:
measure: Target level
timeFrame: 6 hours after bolus
measure: Maintenance level
timeFrame: Up to 14 days
Secondary outcomes:
measure: Seizure cessation
timeFrame: Up to 14 days
measure: Seizure burden change
timeFrame: Up to 14 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Jong Woo Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carlson JM, Molyneaux BJ, Lee JW. Safe Use of Cenobamate in Super Refractory Status Epilepticus: A Case Series. Neurohospitalist. 2023 Apr;13(2):169-172. doi: 10.1177/19418744221147083. Epub 2023 Feb 15.
Clinical trial NCT01763723: Pigment-Tan-Safety Study of a Light-based Home Device for Hair Removal in Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Intense pulsed light,
UV-exposure,
skin type,
safety,
pigment,
home-use
subjects
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2013-01-09
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This studies was designed to investigate the importance of skin type and UV-exposure on side effects after exposure to an Intense Pulsed Light Home-use device.

21 healthy subjects will receive 8 UV-exposures on one buttock and subsequently three weekly IPL-exposures.

Detailed description: Twenty-one healthy subjects will be exposed to UV-exposures 8 times over 3 weeks on a test-area (4 x 6cm) on one buttock to induce pigmentation. This will be followed by 3 weekly IPL (intense pulsed light) exposures. At 24 hours after the first IPL exposure, biopsies will be excised from the buttocks of the subjects (4 each).The skin will be evaluated after IPL exposure for: skin reactions, pain and mRNA expression of two pigment markers. Follow-up visits is planned at 1 and 4 weeks after the third and final IPL exposure.

Eligibility criteria: Inclusion Criteria:

* Healthy, over 18 years, no childbearing potential, signed informed consent, no moles,tattoos, freckles or scars in the test-area, skin type II-IV

Exclusion Criteria:

* disease in test-area, prior treatment to IPL, taking drugs interfering with the immune system

Primary outcomes:
measure: Changes in skin reaction development
timeFrame: Immediately after, 1 hr after, 16-24 hrs after, 1 week and 4 weeks after IPL exposure
Secondary outcomes:
measure: Pain
timeFrame: Immediately after IPL exposure (approx. 2 min)
Other outcomes:
measure: mRNA expression of pigment markers
timeFrame: 16-24 hrs after the first IPL exposure
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
state: Bispebjerg
Study officials:
References:
Clinical trial NCT02175823: Health Status Evaluation for Cancer Survivors by Non-intrusive Sensing System
Official title: Health Status Evaluation for Cancer Survivors by Non-intrusive Sensing System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Keywords: Cancer survivors
circadian rhythm
Elderly Patients
frailty
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-06-26
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Elderly cancer survivors

Brief summary: To improve quality of life of elderly cancer survivors

1. Using physical activity and environmental sensing technology
2. Monitoring physiological indicators of cancer recurrence

   * Analyzing the patient's circadian rhythm, frailty and his/her vital sign.
   * Vital sign includes blood pressure, weight and hrv.
3. Collecting the patient information in real time

   * Giving alarm information to the patient, if any special cases our system found.
   * Giving circadian rhythm report to the patient.
   * Giving healthy report to the patient, collected from his/her vital sign.


Eligibility criteria: Inclusion Criteria:

* The clinical pathology and diagnostic imaging to determine the cancer who completed acute treatment, and patients with more than a month recuperating.
* Over 65 years old.
* Proficient in Chinese or Taiwanese.
* Normal cognitive function

Exclusion Criteria:

* No history of cancer
* Over 65 years old.
* Proficient in Chinese or Taiwanese.
* Normal cognitive function

Primary outcomes:
measure: Quality of Life
timeFrame: Three weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Da'an Dist
Study officials:
affiliation: Computer Science and Information Engineering
name: Li Chen Fu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00380523: Analgesic Treatment Mediated by Arcoxia (0663-093)
Official title: Analgesic Treatment Mediated by Arcoxia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2006-09-26
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Allow physicians to test the efficacy of arcoxia in patients with acute pain.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of acute pain susceptible of pharmacological treatment
* Greater than 18 years of age
* Voluntary acceptance to participate in the study and signature of the informed consent form

Exclusion Criteria:

* Allergy to etoricoxib or any of its components
* Less than 18 years old
* Patient is taking anticoagulants
* Patient that already has taken any drug as analgesic

Primary outcomes:
measure: Evaluate pain using the verbal analog scale (evaluate pain before starting treatment and then evaluate pain every day after had taken arcoxia up to three days)
Secondary outcomes:
measure: Patient satisfaction with the drug therapy using PGART scale
measure: Patient satisfaction was obtained at the end of treatment(on third day)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: