louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01490372: Gestational Diabetes Mellitus and Cardiometabolic Syndrome in Offspring
Official title: Is Gestational Diabetes Mellitus (GDM) an Independent Risk Factor for Cardiometabolic Syndrome in Offspring?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Diabetes Mellitus
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2011-12-13
Enrollment: 41
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Offspring born from GDM pregnancies and their siblings born to the same mothers but from non-GDM pregnancies.

Brief summary: Gestational Diabetes Mellitus (GDM) has long been known as leading to macrosomias, neonatal hypoglycemias and other complications which are treatable and preventable. Nowadays, GDM is recognized as an entity with long-term serious sequels to the mother (GDM is considered a forerunner of type 2 diabetes) and her offspring. Indeed, according to the programming hypothesis, GDM sets the stage for metabolic syndrome, obesity, type 2 diabetes and hypertension. However, these cross-sectional studies failed to control for maternal disease history and genetic background although heredity is a major epidemiology risk factor of type 2 diabetes. Also, studies usually refer to traditional markers such as BMI, blood pressure, lipids profile and oral glucose tolerance test (OGTT); none explored inflammatory biomarkers and adipokines in-depth, despite the possible link between their presence and the development of metabolic and cardiovascular diseases in GDM offsprings.

Exclusion of genetic confounding factors will help establish the role of GDM as an independent marker of cardiometabolic risk in GDM offspring. It is highly relevant to identify GDM as a risk factor for cardiometabolic diseases, given the worldwide obesity epidemic, the alarming prevalence increase of GDM and its serious sequels to both mother and offspring.


Eligibility criteria: Inclusion Criteria:

* age 4 to 12 years
* Tanner stage \< 2
* to understand French or English

Exclusion Criteria:

* Type 1 diabetes
* weight \< 10 kg
* placenta abnormalities
* gestational age \< 34 weeks
* illness affecting growth and metabolism
* taking medications

Primary outcomes:
measure: Metabolic syndrome
timeFrame: 4 to 12 years after birth.
Secondary outcomes:
measure: Inflammatory markers
timeFrame: Assessed only once 4 to 12 years after birth
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre de recherche clinique Étienne-Le Bel du CHUS
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Jean-Luc Ardilouze, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02284672: The Effect of Dexmedetomidine on Propofol Requirement for Insertion of Laryngeal Mask Airway
Official title: The Effect of Dexmedetomidine on Propofol Requirement for Insertion of Laryngeal Mask Airway
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Precedex Effect to Propofol Requirement
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2014-11-06
Enrollment: 39
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Propofol frequently used as an inducting medication for insertion Laryngeal mask airway(LMA). But propofol alone can be not sufficient for inhibiting upper airway reflex and also result in cardiovascular suppression under enough amount. Dexmedetomidine is a selective alplh2 receptor agonist with analgesic and sedative effects but sparing respiratory function. Therefore propofol combined with dexmedetomidine induction could be more effective in preserve respiration under same condition for LMA insertion than propofol alone. In this study, the investigators investigate the clinical dose of propofol for LMA insertion with premedication of dexmedetomidine, and evaluate the effect of dexmedetomidine.


Eligibility criteria: Inclusion Criteria:

* patients for surgery not exceed more than 2 hours requiring general anesthesia

Exclusion Criteria:

* history of gastroesophageal reflux High grade obesity Predicted diffiicult airway

Primary outcomes:
measure: Fail or success for Laryngeal Mask Airway (LMA) insertion
timeFrame: During inserting LMA and up to 5 seconds after LMA inserion
Secondary outcomes:
Other outcomes:
Locations:
city: Suweon
country: Korea, Republic of
facility: Jiyoung Yoo
state: Kyunggido
Study officials:
affiliation: Ajou University School of Medicine
name: Ji Young Yoo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05298072: Identification of Novel Inflammation-related Biomarkers for Early Detection of Anthracycline-induced Cardiotoxicity in Breast Cancer Patients
Official title: Identification of Novel Inflammation-related Biomarkers for Early Detection of Anthracycline-induced Cardiotoxicity in Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiotoxicity
Breast Cancer
Heart Failure
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients presenting to cardio-oncology unit complying with eligibility criteria

Brief summary: This study aims to identify possible set of inflammatory biomarkers before, during and after anthracycline-based chemotherapy in breast cancer patients to identify (sub)clinical chemotherapy-related cardiac dysfunctionCRCD to identify patients who would benefit from additional cardioprotective therapy.


Eligibility criteria: Inclusion Criteria:

* initial diagnosis of breast cancer
* planned Anthracycline-based therapy
* first-line chemotherapy
* first visit before initiation of chemotherapy

Exclusion Criteria:

* previous chemotherapy
* medical history of cardiac disease
* inflammation-modulating medication
* medication with RAS inhibitors
* pregnancy
* autoimmune disease
* drug addictions
* unwilling or unable to provide informed consent

Primary outcomes:
measure: Cardiotoxicity during observational period
timeFrame: continuous evaluation during observational period of 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02405572: Feeding Tolerance Evaluation
Official title: Feeding Tolerance Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: formula-fed
infants
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2015-04-01
Enrollment: 43
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Crossover study of 2 infant formulas

Detailed description: Exclusively formula-fed infants will participate in two 2-week feeding periods of 2 infant formulas. Daily tolerance records will be kept by caregivers.

Eligibility criteria: Inclusion Criteria:

* Healthy newborn infant
* Full-term (\> 37 weeks gestation)
* 0-2 months (birth-56 days) of age on enrollment
* Infant exclusively formula-fed for at least 2 days prior to enrollment
* Having obtained his/her legal representative's informed consent

Exclusion Criteria:

* Known or suspected cow-milk allergy
* Congenital illness or malformation
* Significant prenatal and/or postnatal disease
* Currently participating in another clinical study

Primary outcomes:
measure: stool consistency
timeFrame: 2 weeks
Secondary outcomes:
measure: spit-up pattern
timeFrame: 2 weeks
measure: formula intake
timeFrame: 2 weeks
measure: adverse events
timeFrame: 2 weeks
measure: stool pattern
timeFrame: 2 weeks
measure: mood
timeFrame: 2 weeks
measure: sleep pattern
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Owensboro
country: United States
facility: Pedia Research
state: Kentucky
city: Layton
country: United States
facility: Tanner Clinic
state: Utah
Study officials:
affiliation: Pedia Research
name: Rich Litov, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00010972: Use of Acupuncture for Dental Pain: Testing a Model
Official title: Use of Acupuncture for Dental Pain: Testing a Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tooth, Impacted
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2001-02-05
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This study is testing the safety and effectiveness of acupuncture in controlling pain related to the removal of partially impacted mandibular third molars. Acupuncture is the Chinese art of healing by inserting needles into the skin.

Participants ages 18 - 40 are given an initial x-ray to determine if one lower molar is partially bony impacted. Eligible participants will then undergo standard oral surgery to remove the impacted molar. A local anesthetic will be used prior to surgery. Directly after surgery the participant will be assigned to one of three groups. Participants will not be able to select which group they are assigned. Participants will receive either real or sham (fake) acupuncture as a treatment for post-extraction pain. After the initial acupuncture treatment, participants are required to remain for six hours at the dental site to be monitored. If a participants discomfort is measured as moderate or higher then a second acupuncture treatment will be administered. All participants will be administered questionnaires during the day of surgery. Participants will also be required to complete two diaries during the seven days following surgery. On the seventh day, participants return to have stitches removed and hand in completed diaries.


Eligibility criteria: Inclusion Criteria:

* At least one lower mandibular molar with partial bony impaction
* General good health
* Minimum body weight of 99 lbs.
* Able to read and write in English

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Rivers Center Dental Associates
state: Maryland
Study officials:
affiliation: University of Maryland
name: Sharon Nelson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01726972: A Retrospective Review of FloSeal Use in Total Shoulder Arthroplasty
Official title: A Retrospective Review of FloSeal Use in Total Shoulder Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Shoulder Arthroplasty
Glenohumeral Osteoarthritis
Lead sponsor: Western Orthopaedics Research and Education Foundation
Sponsor class: OTHER
First posted: 2012-11-15
Enrollment: 41
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have previously undergone anatomic total shoulder arthroplasty for the treatment of glenohumeral osteoarthritis.

Brief summary: The proposed study aims to objectively assess 2-year clinical and radiographic results for the rate of glenoid component loosening in total shoulder arthroplasty (TSA). This retrospective radiographic review will provide evidence for equivalence or superiority in curtailing loosening, a known complication in arthroplasty, when a hemostatic agent is utilized in conjunction with cement at the glenoid.


Eligibility criteria: Inclusion Criteria:

* Patients must have completed at least 2 years follow-up following their total shoulder replacement
* Patients must have had radiographic imaging obtained at that 2 years

Exclusion Criteria:

* Patients less than 21 years of age
* Patients who have been imprisoned since the time of surgery
* Patients who are mentally impaired

Primary outcomes:
measure: Radiographic Loosening
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
state: Colorado
Study officials:
References:
Clinical trial NCT06399172: OncoSil Pancreatic Cancer Post-marketing Clinical Registry - Italy
Official title: OncoSil Pancreatic Cancer Post-marketing Clinical Registry Italy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Locally Advanced Pancreatic Adenocarcinoma
Lead sponsor: OncoSil Medical Limited
Sponsor class: INDUSTRY
First posted: 2024-05-03
Enrollment: 50
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: In the participating institutions every patient who is intended to undergo implantation of the OncoSil™ device when used within the approved indication of unresectable, locally advanced pancreatic cancer, in combination with gemcitabine-based chemotherapy, in the commercial (sales) setting will be approached by the Principal Investigator (or delegate) to consent to participate in the OSPRItaly Patient Registry.

Brief summary: The OSPRItaly Patient Registry has been developed to assess the performance and safety of the OncoSil™ device when used within the approved indication of unresectable, locally advanced pancreatic cancer, in combination with gemcitabine-based chemotherapy, within a real-world observational registry.


Eligibility criteria: Inclusion Criteria:

1. Patients who are eligible for and undergo OncoSil™ implantation at an eligible treatment facility according to the approved OncoSil™ System Instructions for Use (IFU), as part of their clinical care.
2. Patients who have completed and signed the Patient Informed Consent Form (PICF) for the OSPRItaly Patient Registry.

Exclusion Criteria:

1. Patients participating in an interventional clinical study (company or investigator-sponsored).
2. Use of an investigational agent at the time of enrolment.

Primary outcomes:
measure: Safety and tolerability
timeFrame: Followed to death or to 24-months after the date of the last enrolled patient.
measure: Tumour response
timeFrame: 1 year
measure: Device implantation Performance
timeFrame: 1 year
measure: Overall Survival
timeFrame: Followed to death or to 24-months after the date of the last enrolled patient
measure: Resection Rates
timeFrame: Followed to death or 24 months after the date of the last enrolled patient
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00374972: Combined Hormonal Versus Progestin Only Contraception During Lactation
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Lactation
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
Collaborators: name: Organon
First posted: 2006-09-12
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: Objective: To determine and compare the effect of low dose estrogen combined hormonal contraceptives and progestin-only contraceptives on lactation.

The subjects will be drawn from a healthy obstetric population in each center, where possible preliminary contact during antenatal period. At the postpartum visit, subjects that express their wish for a hormonal contraceptive method will be offered enrollment. After obtaining an informed consent the participants will be allocated according to their free wish to either receive a combined preparation containing 0.02 mg ethylestradiol and 0.15 mg desogestrel (Mercilon, Organon) or a progestin only pill containing 0.075 mg desogestrel (Cerazette, Organon). Demographic, habits and perinatal data will be collected and stored to analysis.

Frequency and methods of observation: All women will be followed at 6 (baseline), 9 and 12 weeks post - partum. Instruction will be given as to recording information on intercurrent disease, frequency of nursing and use of complementary formula supplements. Maternal BMI calculation ( weight/height2) will be obtained at first visit.

The objective is to compare the capacity of the breast to secrete milk under standard conditions and evaluate the influence of different hormonal contraception means. Thus samples will be collected at 6 weeks (enrollment) and the 9 and 12 weeks visits. An Egnell pump will be used for a maximum of 20 minutes form from both breasts, simulating a regular breast feeding. A total of 10 ml aliquot will be taken for composition analysis and the rest will be offered to the infant. The milk volume/feeding will be estimated and expressed in ml/feeding and multiplied by the number of feedings reported.

Outcome variables: Milk volume, infant growth at each visit and biochemical markers of milk analysis : lipid, casein and carbohydrate content


Eligibility criteria: Inclusion Criteria:

* healthy

Exclusion Criteria:

* mothers to infants that their weight will be below the 10th percentile
* mothers to infants sensitive to milk

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: A resident at the Shaare Zedek Medical Center
name: Naama Srebnik, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: A senior doctor at the Shaare Zedek Medical Center
name: Surina Grisaru-Granovsky
role: STUDY_DIRECTOR
References:
Clinical trial NCT06279572: Immune Profile of Acute Myeloid Leukemia Patients Receiving Azacitidine Plus Venetoclax Induction Chemotherapy
Official title: Immune Profile of Acute Myeloid Leukemia Patients Receiving Azacitidine Plus Venetoclax Induction Chemotherapy: Opportunities for T-Cell Directed Immunotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Myeloid Leukemia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 80
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: Patients with acute myeloid leukemia who received azacitidine plus venetoclax chemotherapy.

Brief summary: This study investigates the immune profile of patients receiving treatment with venetoclax plus azacitidine for acute myeloid leukemia (AML). Studying the information gathered from the immune profile from blood and bone marrow samples may help researchers understand the associated responses to the treatment of patients undergoing therapy of venetoclax plus azacitidine and create future immune based treatment approaches.

Detailed description: PRIMARY OBJECTIVE:

I. To evaluate immune profile of AML patients receiving venetoclax plus azacitidine induction chemotherapy.

SECONDARY OBJECTIVE:

I. To determine clinical responses based on immune infiltrated vs immune depleted subtypes of AML receiving azacitidine and venetoclax chemotherapy.

OUTLINE: This is an observational study.

Patients undergo blood sample collection and bone marrow aspirate on study. Patients' medical records are reviewed.

Eligibility criteria: Inclusion Criteria:

* Adults \> 18 yrs of age with diagnosis of acute myeloid leukemia who received azacitidine plus venetoclax chemotherapy
* Treatment naive adult acute myeloid leukemia patients

Exclusion Criteria:

* Acute myeloid leukemia patients receiving azacitidine and venetoclax as salvage therapy will be excluded
* Patients who are pregnant or breast-feeding

Primary outcomes:
measure: Immune profile of treatment naive acute myeloid leukemia (AML) patients receiving azacitidine plus venetoclax chemotherapy
timeFrame: Baseline (at enrollment)
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Talha Badar, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02890472: Prenatal Examination of Deletion 22q11 Syndrome : Thymic Dysgenesis THYMI Study
Official title: Research of Thymix Dysgenesis in Prenatal Examination of Deletion 22q11 Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 22q11 Deletion Syndrome Di George Syndrome
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 13
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: prenatal diagnosis of a fetal 22q11 deletion syndrome

Brief summary: 22q11.2 microdeletion seems the prenatally under-diagnosed . Indeed , there is a mismatch between the series on the heart rate of 22q11.2 antenatal 84% against 30% in the adult series despite a perinatal mortality of 16% suggesting opportunities for improvement in the prenatal diagnosis of fetus with a microdeletion 22q11.2 , especially without heart disease


Eligibility criteria: Inclusion Criteria:

* all prenatal diagnosis with FISH or CGH array of a fetal 22q11 deletion syndrome during the inclusion period.
* The pregnancy follow-up should be done one of the 44 french fetal medicine unit.
* Sonographic picture of 3 vessels slides should be communicated for independent review.

Exclusion Criteria:

* no sonographic picture available

Primary outcomes:
measure: Thymic thoracic ratio " measurement on sonographic picture of the fetal 3 vessels slides will be done by independent investigator.
timeFrame: day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHUNimes
Study officials:
References: