louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02337582: Colombian Screening Mammography Project
Official title: Pilot Study for Implementing Breast Cancer Early Detection Programs in Colombia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
First posted: 2015-01-13
Enrollment: 15855
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: A cluster randomized controlled trial was performed in Bogotá, Colombia between 2007-2008 to evaluate the effects of an opportunistic (hospital-based) screening program (intervention) vs. usual care (control) in which 26 clinics were randomized to an intervention (N=13) or control arm (N=13). At intervention clinics general practitioners were instructed to perform clinical breast examination (CBE) on all women aged 50-69 years attending clinics for non-breast health related issues, and to refer them for mammographic screening. Physicians from control clinics were not specifically instructed to perform breast-screening or refer women for mammography, but could do so if they thought it appropriate ('usual care'). Women were followed for 2 years post-randomization.


Eligibility criteria: Inclusion Criteria:

Female Aged 50-69 Resident in Bogotá, Colombia or surrounding cities; Had not had a mammogram in the previous two years; No history of breast cancer Attending health-centers for reasons unrelated to breast health

Exclusion Criteria:

* see above

Primary outcomes:
measure: Breast cancer Incidence
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
References:
citation: Murillo R, Diaz S, Perry F, Poveda C, Pineros M, Sanchez O, Buitrago L, Gamboa O, Lozano T, Yu H, Wang CY, Duggan C, Thomas DB, Anderson BO. Increased breast cancer screening and downstaging in Colombian women: A randomized trial of opportunistic breast-screening. Int J Cancer. 2016 Feb 1;138(3):705-13. doi: 10.1002/ijc.29801. Epub 2015 Sep 2.
Clinical trial NCT01903382: Circadian, Weekly and Seasonal Variability of Postoperative Mortality and Morbidity (Zirkadianest)
Official title: The Association Between Circadian, Weekly, and Seasonal Effects and Time of Surgery on Postoperative Morbidity and Mortality of Patients (Zirkadianest)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Mortality and Morbidity
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2013-07-19
Enrollment: 247506
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing general anesthesia between January 2006 and December 2013. They are followed up until hospital discharge.

Brief summary: Mortality is subject to cyclic variability: circadian, weekly, and seasonal. This has been shown for different populations, different diseases and in different countries, but not for surgical patients. Aim of this study is therefore to investigate the association between circadian, weekly, and seasonal effects time of surgery postoperative mortality of patients undergoing surgery and general anesthesia.


Eligibility criteria: Inclusion Criteria:

All Patients who underwent anesthesia within the study time period.

Exclusion Criteria:

none

Primary outcomes:
measure: Postoperative mortality
timeFrame: One year
Secondary outcomes:
measure: Hospital length of stay
timeFrame: One year
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte and Campus Virchow-Klinikum, Charité - University Medicine
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04093882: The Relevance of the Blood-brain Barrier to Cognitive Dysfunction and Alzheimer's Disease
Official title: The Relevance of the Blood-brain Barrier to Cognitive Dysfunction and Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Brain Barrier
Alzheimer Disease
Cognitive Dysfunction
Dementia
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Prof. Dr. med. Jochen Fiebach (Senior Physician)
First posted: 2019-09-18
Enrollment: 101
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A description of the study population is provided by DZNE - Longitudinal Cognitive Impairment and Dementia Study (DELCODE).

Brief summary: This study attempts to replicate the findings published in Nature Medicine by Nation and colleagues (2019). By using a large observational cohort (DZNE - Longitudinal Cognitive Impairment and Dementia Study; DELCODE) consisting of cognitively healthy individuals, individuals with subjective cognitive decline, mild cognitive impairment, and dementia due to Alzheimer's disease, an association between the blood-brain barrier and cognitive dysfunction is investigated. The integrity of the blood-brain barrier is investigated by using a novel MRI protocol as well as a novel biomarker in the cerebrospinal fluid.


Eligibility criteria: Inclusion criteria:

- ≥ 50 years with neuropsychologically confirmed no cognitive dysfunction, mild cognitive impairment or mild dementia

Exclusion cirteria:

* no current or prior history of any neurological or psychiatric condition, which might affect cognitive function
* no neurodegenerative disease other than AD
* specifically no extensive vascular white matter dementia or vascular dementia

Primary outcomes:
measure: Marker of blood-brain dysfunction using MRI
timeFrame: 1 day
measure: Markers of blood-brain dysfunction using CSF
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
Study officials:
References:
Clinical trial NCT03358082: Effectivness of Topical Tacrolimus Monotherapy in Patients With Vitiligo
Official title: Effectivness of Topical Tacrolimus 0.03% Monotherapy in Patients With Vitiligo: Arandomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Vitiligo
Tacrolimus
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2017-11-30
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will evaluate the effectiveness of Tacrolimus 0.03% ointment monotherapy in patients with vitiligo. Patients will be treated for 6 months and followed for 3 months after treatment. All types of vitiligo will be included.

Detailed description: Study approval: The study was submitted for approval by Scientific and Ethical Committee at Faculty of Medicine, Sohag University. An informed written consent will be obtained from all participants.

Study design: randomized controlled trial. Study population: the study will include patients who attend the outpatient Clinic of Dermatology \& Venereology and Andrology, Faculty of Medicine, Sohag University in corporation with Farshot General Hospital. Women who are pregnant or lactating, children aged 2 years or less and patients with acute or chronic disease that might affect skin barrier function will be excluded.

Patients and methods:

Study participants will be randomly divided into two treatment groups: group A will receive 0.03% tacrolimus ointment and group B will receive hydrocortisone acetate 1% ointment twice daily for 6 months.

Patients will be evaluated at baseline and monthly intervals for 6 months and at 3 months after stopping treatment.

Eligibility criteria: Inclusion Criteria:

* all patients with clinical diagnosis of vitiligo

Exclusion Criteria:

* children =or \<2 years old, women who are pregnant or lactating, patients with acute or chronic disease that might affect skin barrier function.

Primary outcomes:
measure: Vitiligo Area Scoring Index (VASI)
timeFrame: basline to 9 months
Secondary outcomes:
measure: Vitiligo Disease Activity (VIDA) Score
timeFrame: baseline to 9 months
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
affiliation: Sohag Faculty of Medicine, Sohag University
name: Ramadan Saleh, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03542682: The Effect of Bolus Speed of Rapid-Acting Insulin Analog Absorption and Action in Individuals With Type 1 Diabetes
Official title: The Effect of Insulin Bolus Speed of Rapid-Acting Insulin Analog Absorption and Action in Individuals With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type1diabetes
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2018-05-31
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study will be a cross-over, randomized order, single blinded clinical study in subjects with Type 1 Diabetes.
Primary purpose: BASIC_SCIENCE

Brief summary: Rapid Action Insulin (RAI) absorption and action measured by time to reach maximum insulin concentration and glucose infusion rate.

Detailed description: The investigators hypothesize that RAI absorption and action measured by time to reach maximum insulin concentration and glucose infusion rate during the clamp study will be significantly faster when insulin bolus is delivered using the "Quick Bolus" feature as compared to the "Standard Bolus".

Outcomes were updated at time of results entry.

Eligibility criteria: Inclusion Criteria:

1. Age 18 - 30 (inclusive)
2. Clinical diagnosis of T1D of at least one year's duration
3. On Continuous Subcutaneous Insulin Infusion (CSII) therapy for at least three months
4. HbA1c \<10%
5. Minimum weight requirement of at least 37.9 kg
6. Ability to comprehend written and spoken English
7. Total daily requirement of insulin between 0.6 and1.2 U/kg/day
8. Not have any other medical condition or disease known to affect insulin action and glucose control aside from T1D or treated hypothyroidism

Exclusion Criteria:

1. Medication besides insulin known to alter blood glucose or insulin action
2. Female subjects of reproductive potential that are pregnant or breast feeding, or not consistently using a barrier method or abstinence as contraception.
3. Inability to comprehend written and spoken English
4. Any other condition, which in the judgment of the investigators, would interfere with the subject's ability to provide informed consent or the investigator's ability to perform the study
5. Hematocrit less than 35% or a serum potassium less than 3.4 mmol/L

Primary outcomes:
measure: Time to Maximum Glucose Infusion Rate
timeFrame: 300 minutes
Secondary outcomes:
measure: Earlier Clearance of Exogenous Insulin.
timeFrame: up to 5 hours
measure: Maximum Glucose Infusion Rate
timeFrame: 300 minutes
measure: Area Under the Curve for the Glucose Infusion Rate
timeFrame: 300 minutes
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Eda Cengiz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06011382: Maxillary Molar Distalization Supported by Mini-implants With the Advanced Molar Distalization Appliance (Amda®)
Official title: Maxillary Molar Distalization Supported by Mini-implants With the Advanced Molar Distalization Appliance (Amda®): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Angle Class II
Keywords: amda®
maxillary molar distalization
randomized controlled trial
orthodontics
Lead sponsor: Grigore T. Popa University of Medicine and Pharmacy
Sponsor class: OTHER
Collaborators: name: Aristotle University Of Thessaloniki
First posted: 2023-08-25
Enrollment: 16
Sex: ALL
Minimum age (years): 14
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arm parallel randomized controlled trial with 1:1 allocation ratio
Primary purpose: TREATMENT

Brief summary: The aim of this randomized controlled clinical trial is to evaluate the dentoalveolar and skeletal treatment effects of the AMDA when used for distalization of the maxillary first molars in patients with Class II malocclusion in the permanent dentition.

Detailed description: The primary aim is to evaluate two different treatment groups from initiation of treatment up until completion of maxillary molar distalization of:

* Group I: patients treated with amda®
* Group II: patients treated with buccal mini-implants

More specifically to evaluate the efficiency of the AMDA using lateral cephalograms and digital 3D model casts of the patients under investigation at the following time points:

* point T0: baseline data - before initiation of the treatment
* point T1: immediately after distalization (8-12 months)

Eligibility criteria: Inclusion Criteria:

* All patients to have permanent dentition
* with or without the 2nd molar erupted
* bilateral Class II molar relationships (a quarter to 1 molar cusp).

Exclusion Criteria:

* Past orthodontic treatment
* crossbites,
* severe carious lesions,
* poor oral hygiene,
* mobility of the maxillary first molars,
* anterior open bites,
* vertical growth pattern,
* tongue habits.

Primary outcomes:
measure: Anteroposterior position changes of upper first molars.
timeFrame: 8-12 months
measure: Measurements on the lateral cephalograms and digital 3D model casts.
timeFrame: 8-12 months
measure: Measurements on the lateral cephalograms and digital 3D model casts.
timeFrame: 8-12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Iasi
country: Romania
facility: University of Medicine and Pharmacy "Grigore T. Popa"
Study officials:
affiliation: Grigore T Popa University, Department of Orthodontics
name: Nikolaos Karvelas, PhD student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03241082: Ultrasound Assessment of BC in the NICU
Official title: Use of Bedside Ultrasound to Assess Neonatal Body Composition in the Neonatal Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Premature Infant
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2017-08-07
Enrollment: 68
Sex: ALL
Minimum age (years): 25
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants admitted to the University of Minnesota NICU under the care of the PI and/or her colleagues.

Brief summary: The overall objective of the proposal is to evaluate the ability of ultrasound to predict and routinely (weekly) monitor changes in the body composition of healthy preterm infants in the neonatal intensive care unit (NICU) in response to nutritional intake. The investigators hypothesize that ultrasound is an accurate method to routinely monitor the quality of weight gain and assess the adequacy of nutritional provision for premature infants in the neonatal intensive care unit.

The investigators will address the hypothesis in the following Specific Aims:

Specific Aim 1: Validate ultrasound as a method to measure whole body fat mass and fat free mass in healthy, premature infants. Body composition will be assessed using ultrasound measurements and the validated method of air displacement plethysmography (ADP). Stable isotope dilution techniques will be used in a subset of our population as a secondary source of validation.

Specific Aim 2: Determine whether ultrasound measurements can detect clinically relevant (weekly) changes in body composition in healthy premature infants. Ultrasound will be used to obtain serial (weekly) measurements of muscle and adipose tissue thickness (triceps, abdomen, quadriceps) until discharge in healthy, premature infants.


Eligibility criteria: Inclusion Criteria:

* Healthy, premature infants 25-34+6 weeks gestational age at birth
* Admitted to the University of Minnesota Masonic Children's Hospital NICU
* Stable on room air or can be removed from respiratory support for 5 minutes
* Written or verbal (telephone) informed consent can be secured from a parent within 1 week of admission to the NICU

Exclusion Criteria:

-Require medical support preventing ADP measurements

Primary outcomes:
measure: Whole-body measurements of body composition
timeFrame: Up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Masonic Children's Hospital
state: Minnesota
Study officials:
affiliation: University of Minnesota Department of Pediatrics
name: Sara Ramel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00669682: T-wave Alternans and Intrathoracic Impedance Measurements
Official title: T-wave Alternans and Intrathoracic Impedance Measurements
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congestive Heart Failure
Arrhythmias
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2008-04-30
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Class III or IV heart failure patients

Brief summary: T-wave alternans is a test that is currently being used to risk stratify patients with structural heart disease for sudden cardiac death. The mechanism of T-wave alternans is unclear, but may share a common abnormality with conditions of cardiac fluid overload such as heart failure, which is altered intracellular calcium handling. Current Medtronic implantable defibrillators have the capability of monitoring cardiac fluid status via transthoracic impedance measurements.

The purpose of this study is to determine if a correlation exists between T-wave alternans status and cardiac volume status, as determined by transthoracic impedance measurements. Secondarily, the study seeks to examine the relationship between arrhythmia frequency and T-wave alternans or cardiac volume status.


Eligibility criteria: Inclusion Criteria:

* Class III or IV heart failure patients with a chronically implanted Medtronic biventricular defibrillator system capable of monitoring intrathoracic fluid volume.

Exclusion Criteria:

* no active ischemia or pulmonary edema, atrial fibrillation, complete heart block

Primary outcomes:
measure: Number of Positive Twave Studies and Concurrent Positive Optivol Measurement
timeFrame: upto 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Jose M Dizon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06991582: Clinical Assessment of Injectable Composite Versus Packable Composite in Treatment of Carious Primary Anterior Teeth
Official title: Clinical Assessment of Injectable Composite Versus Packable Composite in Treatment of Carious Primary Anterior Teeth: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Carious Primary
Carious Anteriors
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be recruited from outpatient clinic of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry Cairo University. Patients will be carefully assessed for eligibility to participate in our study then a full explanation of the nature of our experiment will be provided for parents or guardian before obtaining the informed consent from them.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the clinical success of injectable composite versus packable composite in restoration of primary anteriors.


Eligibility criteria: Inclusion Criteria:

* Children with caries in primary anterior teeth.
* Caries involving class III, IV, V or multisurface caries
* Restorable anterior teeth
* Pre operative Radiograph showing at least half of the root is not resorbed).

Exclusion Criteria:

* Badly decayed non restorable anterior teeth
* Signs and symptoms of root resorption (more than half the root is resorbed)
* Presence of bony resorption
* Presence of pathological root resorption
* Tooth Mobility

Primary outcomes:
measure: Direct Clinical Assessment of Restoration
timeFrame: through study completion, on average of 1 year
measure: Direct Clinical Assessment of Restoration
timeFrame: through study completion, on average of 1 year
measure: Direct Clinical Assessment of Restoration
timeFrame: through study completion, on average of 1 year
measure: Direct Clinical Assessment of Restoration
timeFrame: through study completion, on average of 1 year
measure: Direct Clinical Assessment of Restoration
timeFrame: through study completion, on average of 1 year
measure: Direct Clinical Assessment of Restoration
timeFrame: through study completion, on average of 1 year
measure: Direct Clinical Assessment of Restoration
timeFrame: through study completion, on average of 1 year
Secondary outcomes:
measure: Parents' patient Satisfaction
timeFrame: immediately after the intervention/procedure
measure: Chair side time
timeFrame: immediately after the intervention/procedure
measure: Plaque accumulation
timeFrame: through study completion, on average of 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Pediatric Dentistry Department, Faculty of Dentistry, Cairo University
Study officials:
References: