louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03316261: Freder1k-Study - Testing Infants for Type 1 Diabetes Risk
Official title: Freder1k-Study - Identification of Infants With Increased Type 1 Diabetes Risk for Enrollment Into Primary Prevention Trials
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Identification of Infants at Risk for Type 1 Diabetes
Keywords: infants
type 1 diabetes
Freder1k
Lead sponsor: Helmholtz Zentrum München
Sponsor class: INDUSTRY
First posted: 2017-10-20
Enrollment: 1000000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The Freder1k-Study will identify infants who have a high genetic risk of type 1 diabetes.

Brief summary: The Freder1k-Study will identify infants who have a high genetic risk of type 1 diabetes.

Detailed description: Type 1 diabetes is a common chronic disease in childhood and is increasing in incidence. Type 1 diabetes is diagnosed by hyperglycemia often in combination with symptoms of weight loss, thirst, fatigue and frequent urination, sometimes with ketoacidosis. The clinical onset is preceded by an asymptomatic phase identified by serum multiple beta-cell autoantibodies. Neonates and infants who are at increased risk to develop multiple beta-cell autoantibodies and type 1 diabetes can now be identified using genetic markers. This provides opportunity for introducing early therapies to prevent beta-cell autoimmunity and type 1 diabetes.

Eligibility criteria: Inclusion Criteria:

* Age: up to age 6 weeks
* provided written informed consent by custodial parent

Exclusion Criteria:

-

Primary outcomes:
measure: greater than 10% risk for multiple beta-cell autoantibodies/type 1 diabetes
timeFrame: one-time testing before age 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Institut für Diabetesforschung, Helmholtz Zentrum München
Study officials:
affiliation: Helmholtz Zentrum München, IDF-1
name: Anette-Gabriele Ziegler
role: STUDY_CHAIR
References:
citation: Hippich M, Holthaus L, Assfalg R, Zapardiel-Gonzalo J, Kapfelsperger H, Heigermoser M, Haupt F, Ewald DA, Welzhofer TC, Marcus BA, Heck S, Koelln A, Stock J, Voss F, Secchi M, Piemonti L, de la Rosa K, Protzer U, Boehmer M, Achenbach P, Lampasona V, Bonifacio E, Ziegler AG. A Public Health Antibody Screening Indicates a 6-Fold Higher SARS-CoV-2 Exposure Rate than Reported Cases in Children. Med. 2021 Feb 12;2(2):149-163.e4. doi: 10.1016/j.medj.2020.10.003. Epub 2020 Oct 29.
Clinical trial NCT01666561: The Effect of Oat Based Breakfast Cereals on Satiety and Food Intake.
Official title: The Effect of Oat Based Breakfast Cereals on Satiety and Food Intake.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Intake
Satiety
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: PepsiCo Global R&D
name: Quaker Oats Company
First posted: 2012-08-16
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To test the hypothesis that two 40 gm serving of Oat-based breakfast cereals compared to an equicaloric amount of a ready-to-eat Oat-based breakfast cereal will give greater satiety over the 4 hour period following breakfast.

Detailed description: The subjects will be randomly assigned to one of these three breakfasts and then given a Visual analogue scales of hunger and satiety which will be completed at baseline, 30, 60, 120, 180, and 240 minutes. Subjects will return on 2 other days separated by at least a week to repeat the breakfast test.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older and are healthy.
* Taking no regular medications other than birth control or hormone replacement therapy.
* Are willing to use an effective method of birth control if you are capable of bearing children. Acceptable methods include abstinence, barrier methods, intrauterine devices, and hormonal methods of contraception.

Exclusion Criteria:

* Are a woman who is pregnant or nursing a baby.
* Have gained or lost 8.8 pounds or more in the last 3 months.
* Have diabetes or a fasting blood sugar over 126 mg/dL.
* Have a score of 14 or greater on the restraint scale of the 3-factor eating questionnaire (a questionnaire which will be given to you by the study staff).
* Are allergic to oats, lactose-free milk, Honey Nut Cheerios or oatmeal.

Primary outcomes:
measure: Satiety Impact
timeFrame: up to day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
References:
Clinical trial NCT02156661: Oxytocin and Emotion Processing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Males
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2014-06-05
Enrollment: 97
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether oxytocin influences emotional processing and learning of emotional and social stimuli.

Detailed description: An effect of OXT on emotion processing and anxiety has been broadly investigated in animal studies. However, in humans, effects seem more complex.

The rationale of the study is to examine direct effects of OXT to processing and learning of emotional and social values in humans.

Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers

Exclusion Criteria:

* Current or past psychiatric disease
* Current or past physical illness
* Psychoactive medication
* Tobacco smokers
* MRI contraindication

Primary outcomes:
measure: Brain activity
timeFrame: During emotion processing
Secondary outcomes:
measure: Psychophysiological response
timeFrame: During stimuli presentation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04483661: Development of Systems and Precision Medicine - Take Mood Disorder as an Example.
Official title: Development of Systems and Precision Medicine - Take Mood Disorder as an Example.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mood Disorders
Keywords: mood disorder, neurocognitive function, metabolic disturbances, microbiota-gut-brain axis, genetic variant, pharmacogenomics
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 200
Sex: ALL
Minimum age (years): 20
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: Subjects who met the criteria will be successively recruited from the National Cheng Kung University Hospital.

Brief summary: Precision medicine is to achieve individual optimal health care, given the biological mechanisms, genetic variants, and environmental measurements. Take mood disorder (MD) as an example, we aim to develop systems and precision medicine in Taiwanese population.

MD is a very serious and dysfunctional mental disorder. Since MD patients with treatment have high risk of neurocognitive impairment and metabolic disturbances, the therapeutic strategies are of clinical importance. Individual difference of treatment outcome in MD patients would result from genetic variants, environmental factors, and their interactions. Also, the treatment outcome of MD contains multiple dimensions, including improvement of disease severity, neurocognitive function, and optimized medication strategy. However, comprehensive development of approaches to investigate the multiple dimensions of treatment outcome in MD patients is limited. In this three-year proposal, we explore the interactions of genetic variants and environmental factors (represented by psychosocial stress and gut microbiota) driven approaches to develop precision medicine.


Eligibility criteria: Inclusion Criteria:

* Male or female patients, 20- 70 years of age
* Major depression disorder who met the DSM-V diagnostic criteria were enrolled
* Subjects take at least one kind of antidepressant.

Exclusion Criteria:

* Pregnant or breast-feeding
* Presence of any other major psychiatric illness
* History of substance and alcohol abuse or dependence
* Presence of auto-immune disorder and infectious diseases

Primary outcomes:
measure: Depression severity
timeFrame: six months
Secondary outcomes:
measure: The influence of environmental factor in mood disorder
timeFrame: six months
measure: cognitive function assessed using the Finger Tapping Test (FTT)
timeFrame: six months
measure: cognitive function assessed using Wisconsin Card Sorting Test (WCST)
timeFrame: six months
measure: cognitive function assessed using Continuous Performance Test (CPT)
timeFrame: six months
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University (NCKU) Hospital
Study officials:
References:
Clinical trial NCT02893761: Bergonie Institute Breast Cancer Database
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: breast cancer
survival
prognosis factors
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 21439
Sex: FEMALE
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: Patient with breast cancer treated at Bergonie Institute

Brief summary: A database of breast cancer patients was established at Institute Bergonié since the 90s , to assess patients' survival, assess practice, search for prognostic factors.


Eligibility criteria: Inclusion Criteria:

* Breast cancer
* Aged 18 years and over
* First treatment at Bergonie Institute

Exclusion Criteria:

-

Primary outcomes:
measure: Overall Survival
timeFrame: 5 years
measure: Overall Survival
timeFrame: 10 years
Secondary outcomes:
measure: Distant disease-free survival
timeFrame: 10 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03066661: Expanded Access to Entrectinib for Cancers With NTRK1/2/3, ROS1, or ALK Gene Fusions
Official title: Expanded Access to Entrectinib (RXDX-101) for the Treatment of Cancers With NTRK, ROS1, or ALK Gene Fusions
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Cancers With NTRK, ROS1, or ALK Gene Fusions
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2017-02-28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Expanded access to entrectinib will be given to patients with cancers harboring NTRK1/2/3, ROS1, or ALK gene fusions who do not qualify for participation in, or who are otherwise unable to access, an ongoing clinical trial for entrectinib.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of advanced cancer with an NTRK1, NTRK2, NTRK3, ROS1, or ALK gene fusion
* Unable to participate in an ongoing entrectinib (RXDX-101) clinical trial
* Willing and able to provide written, signed informed consent
* Medically suitable for treatment with entrectinib (RXDX-101)

Exclusion Criteria:

* Currently enrolled in an ongoing clinical study with any other investigational agent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: 1-844-Startrk (782-7875)
state: California
Study officials:
References:
Clinical trial NCT03235661: Bi-level Positive Airway Pressure for Respiratory Distress Syndrome in Twins Infants
Official title: Bi-level Positive Airway Pressure for Respiratory Distress Syndrome in Twins:A Randomized Controlled Trials
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: nCPAP
BiPAP
Respiratory Distress Syndrome
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
First posted: 2017-08-01
Enrollment: 300
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: BiPAP and nCPAP are used as primary mode of ventilation in preterm twins infants with RDS
Primary purpose: TREATMENT

Brief summary: The investigators compared advantages and disadvantages of two forms of noninvasive respiratory support -bi-level positive airway pressure(BiPAP) or nasal continuous positive airway pressure (nCPAP) -as a primary mode of ventilation in preterm twins infants with respiratory distress syndrome

Detailed description: Invasive ventilation is related to development of adverse pulmonary and nonpulmonary outcomes in ventilated infants. Various modes of noninvasive respiratory support are being increasingly used to minimize the incidence of bronchopulmonary dysplasia (BPD). The aim of this trial to compare the effects of bi-level positive airway pressure(BiPAP) and nasal continuous positive airway pressure (NCPAP) in preterm twins infants as the primary mode.

Eligibility criteria: Inclusion Criteria:

* 1. Gestational age (GA) is from 26 to 37 weeks;
* 2. Diagnosis of respiratory distress syndrome. The diagnosis of respiratory distress syndrome will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and chest X-ray findings;
* 3. Respiratory distress syndrome Silverman score \>5;
* 4. Informed parental consent has been obtained.

Exclusion Criteria:

* 1. Severe respiratory distress syndrome requiring early intubation according to the American Academy of Pediatrics guidelines for neonatal resuscitation;
* 2. Major congenital malformations or complex congenital heart disease;
* 3. Group B hemolytic streptococcus pneumonia, septicemia, pneumothorax, pulmonary hemorrhage;
* 4. Cardiopulmonary arrest needing prolonged resuscitation;
* 5. transferred out of the neonatal intensive care unit without treatment.

Primary outcomes:
measure: intubation rate
timeFrame: within 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of Pediatrics, Daping Hospital, Third Military Medical University
state: Chongqing
Study officials:
affiliation: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
name: Shi Yuan, PhD,MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00135161: Feasibility Study of Incorporating 18F-FDG-PET Imaging in Radiotherapy for Head and Neck Cancer
Official title: Feasibility Study of Incorporating 18F-FDG-PET Imaging in Radiotherapy for Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Head and Neck Neoplasms
Keywords: neoplasms (squamous cell carcinoma of the head and neck region)
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Belgian Federation Against Cancer
First posted: 2005-08-25
Enrollment: 40
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 purpose of this trial is to study fluorodeoxyglucose-positron emission tomography (FDG-PET)-based dose escalation using intensity modulated radiation therapy (IMRT).

Detailed description: The dose escalation, based on the FDG-PET signal, is incorporated in the first ten fractions of the radiotherapeutic treatment. The total amount of fractions is 32, equal to a standard radiotherapeutic treatment for these types of cancers.

Eligibility criteria: Inclusion Criteria:

* Patients with a proven histological squamous cell carcinoma of the larynx (only T3-4 NO or Tany N+), hypopharynx, oropharynx
* Patients who did not undergo surgery for the primary tumor location
* Patients with a Karnofsky performance score of 70% or more
* Written informed consent for participation in this trial

Exclusion Criteria:

* Other malignancy except for non-melanoma skin cancer
* Prior irradiation to the head and neck region

Primary outcomes:
measure: Acute toxicity during radiotherapy until 3 months after the end of the radiotherapy
timeFrame: until 3 months after the end of the radiotherapy
measure: Observation of chronic toxicity
timeFrame: until 3 months after the end of the radiotherapy
Secondary outcomes:
measure: Therapy response (2-4 months after end of radiotherapy)
timeFrame: 2-4 months after end of radiotherapy
measure: Local control at 2 years
timeFrame: at 2 years
measure: Pattern of recurrence
timeFrame: at 2 years
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Wilfried De Neve, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03300661: Non Alcoholic Fatty Liver Disease: Nutritional Epidemiology and Lifestyle Medicine
Official title: Open-label, Non-Pharmacological, Intervention Cohort Study Without Control Arm, in Patients With Non Alcoholic Fatty Liver Disease and in Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Alcoholic Fatty Liver Disease
Lifestyle
Diet Modification
Lead sponsor: Università degli Studi di Brescia
Sponsor class: OTHER
First posted: 2017-10-03
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single cohort of patients with NAFLD, without control group.
Primary purpose: TREATMENT

Brief summary: The study is an open-label intervention non pharmacological Cohort Study without control arm in patients with Non Alcoholic Fatty Liver Disease (NAFLD) and in healthy subjects.

The intervention in patients with NAFLD is educational, providing personalized suggestions to improve diet and physical activity; the intervention in healthy subjects is educational, providing general suggestions to improve diet and physical activity.


Eligibility criteria: Inclusion Criteria:

* Presence of Fatty Liver at ultrasonography

Exclusion Criteria:

* Pregnancy;
* Breast Feeding
* Cirrhosis or End Stage Liver Disease
* Fatty Liver due to Hepatic Diseases other than Non Alcoholic Fatty Liver disease
* Concomitant severe clinical condition

Primary outcomes:
measure: Weight loss
timeFrame: 12 months
measure: Body Mass Index (BMI) decrease
timeFrame: 12 months
measure: Waist Circumference (WC) decrease
timeFrame: 12 months
Secondary outcomes:
measure: Blood sugar level decrease
timeFrame: 12 months
measure: Blood cholesterol level decrease
timeFrame: 12 months
measure: Blood triglycerides level dicrease
timeFrame: 12 months
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: ASST Spedali Civili Brescia
Study officials:
affiliation: Università degli Studi di Brescia
name: Chiara Ricci, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01978561: Follow-Up Of Pregnancies Established During Study NT-03 (Thrive-IVF Follow-Up)
Official title: Pregnancy, Delivery, And Neonatal Outcomes In Subjects With Ongoing Pregnancies Established During Study NT-03 (Thrive-IVF Follow-Up)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Repeated IVF Failure
Lead sponsor: Nora Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-07
Enrollment: 40
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate pregnancy, delivery, and neonatal outcomes in subjects who maintain ongoing clinical pregnancies through Week 10 of gestation in NT-03.

Detailed description: NT-04 is a follow-up study that will include subjects who received at least one dose of study drug and maintain ongoing clinical pregnancies through Week 10 of gestation during NT-03. NT-04 does not involve the administration of study drug treatment.

In NT-03, subjects who achieve an ongoing clinical pregnancy at Week 8 of gestation will undergo a repeat transvaginal ultrasound (TVU) at Week 10 of gestation (4 weeks after last dose of study drug). Subjects who are pregnant at Week 10 of gestation will be enrolled in NT-04.

Subjects in NT-04 will be contacted by telephone every 6 to 8 weeks until Week 38 of gestation, at which time subjects will be contacted every two weeks until confirmation of delivery. Information about pregnancy status and use of prescription medications will be collected at these telephone interviews.

Between Weeks 18 and 22 of gestation, an obstetrical ultrasound will be performed.

Following delivery, additional information will be obtained, including pregnancy outcome, gestational age at delivery, etc. Standardized photographs will be taken as part of a newborn assessment.

Eligibility criteria: Inclusion Criteria:

* At least one dose of study drug administered in NT-03
* Ongoing clinical pregnancy at Week 10 of gestation
* Able and willing to enroll in NT-04

Exclusion Criteria:

• None

Primary outcomes:
measure: Number of live births
timeFrame: Within approximately 7 months after NT-03
Secondary outcomes:
measure: Number of stillbirths
timeFrame: Within approximately 7 months after study NT-03
measure: Number of spontaneous abortions (miscarriages)
timeFrame: Within approximately 7 months after study NT-03
measure: Number of congenital anomalies
timeFrame: Up to 4 weeks after birth
measure: Number of severe neonatal adverse events
timeFrame: Up to 4 weeks after birth
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03837561: The Efficacy and Safety of CUNOX® in Patients With Moderate to Severe Glabellar Lines
Official title: Phase Ⅲ, Randomized, Double-Blind, Active Controlled, Multi-Center, Clinical Trial to Evaluate the Efficacy and Safety of CUNOX® in Patients With Moderate to Severe Glabellar Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glabellar Frown Lines
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2019-02-12
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To Confirm the non-inferiority of CUNOX® to BOTOX® in the glabellar line improvement of moderate to severe glabellar lines.


Eligibility criteria: Inclusion Criteria:

* Men and women aged between 18 and 65
* Subjects attaining ≥ grade 2 (moderate) in the investigator's rating of the severity of glabellar lines at maximum forced frown
* Subjects who voluntarily sign the informed consent

Exclusion Criteria:

* Subjects with allergy or hypersensitivity to the investigational drugs or their components
* Subjects who are participating in other clinical trials or have participated in clinical trials 30 days before screening
* Subjects who are not eligible for this study at the discretion of the investigator

Primary outcomes:
measure: Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment of glabellar line severity
timeFrame: at 4 weeks after the injection.
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Medical Center Capital-Health
Study officials:
References: