louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05510284: Post-partum Care in the NICU
Official title: Post-partum Care in the NICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Period
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 37
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a pilot randomized control trial to demonstrate the feasibility of a novel model of dyad-centered, doula-coordinated, midwife-delivered postpartum care located in the NICU in a large urban hospital.


Eligibility criteria: Inclusion Criteria:

* Preterm birth \<34 weeks
* Signed medical record release form

Exclusion Criteria:

* Unable to read or sign informed consent
* If the medical team believes that the infant may die or be transferred to another hospital in upcoming weeks
* PI Discretion

Primary outcomes:
measure: Time to receipt of postpartum care
timeFrame: birth until 6 weeks post-partum
Secondary outcomes:
measure: Comparison of effectiveness of intervention for mothers with public vs private insurance
timeFrame: birth until 6 weeks post-partum
measure: Comparison of effectiveness of intervention for mothers with infants less than 29 weeks gestational age vs those 29 weeks or older.
timeFrame: birth until 6 weeks post-partum
measure: Receipt of Postpartum care
timeFrame: birth until 6 weeks post-partum
Other outcomes:
measure: Health related quality of life measured by the CDC Health-Related Quality of Life (HRQOL)
timeFrame: 6 months postpartum
measure: Depression measured by the Edinburgh Postnatal Depression Scale
timeFrame: 6 months postpartum
measure: Health care utilization - Number of visits
timeFrame: Time of birth until 6 months postpartum
measure: Breastfeeding- ever
timeFrame: 6 months postpartum
measure: Breastfeeding- length of time exclusive breastmilk
timeFrame: 6 months postpartum
measure: Breastfeeding- age at stopping breastmilk
timeFrame: 6 months postpartum
measure: Diet
timeFrame: 6 months postpartum
measure: Physical activity
timeFrame: 6 months postpartum
measure: Posttraumatic stress disorder symptoms (PTSD)
timeFrame: 6 months postpartum
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00394784: Surveillance Study - Incidence of Antibiotic Resistance in Serial Gram-negative Bloodstream Isolates
Official title: Surveillance Study - Incidence of Antibiotic Resistance in Serial Gram-negative Bloodstream Isolates
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Gram-negative Bacterial Infections
Keywords: gram negative bacteria
culture
infection
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2006-11-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: positive gram negative bacteria isolates

Brief summary: This research is important because it allows for the determination of resistance rates to antibiotics that may not be frequently tested by the clinical microbiology laboratory at University of Pittsburgh Medical Center (UPMC)-Presbyterian. It also will provide antibiotic minimum inhibitory concentrations (MICs) for these pathogens which may help in identifying the best empiric antibiotic option for gram-negative blood stream infections based on known pharmacodynamic parameters.

Detailed description: Bacterial cultures will be ordered in the normal clinical course of the management of patients in the liver transplant ICU by the medical team. These cultures are then processed by the clinical Microbiology laboratory in the normal manner. If these cultures grow a Gram-negative bacteria, they are eligible for this study. Typically the clinical Microbiology laboratory saves these bacteria for a period of time after the final microbiology report. At this time, unless asked otherwise, the bacteria will be placed in biohazardous waste containers for proper disposal. If these cultures have grown a Gram-negative bacteria, they are eligible for this study, and will not be disposed of but will be given to the investigators without identifiers for this study. The antibiotic susceptibility of these organisms will be tested by the investigators in a separate research laboratory. Mechanisms of antibiotic resistance may also be assessed.

Eligibility criteria: Inclusion Criteria:

* Patients with positive gram-negative bacteria

Exclusion Criteria:

* Less than 18 years of age

Primary outcomes:
measure: dead or alive
timeFrame: end of study
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Brian Potoski, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02473484: Search of Protein Biomarkers in Order to Achieve a Molecular Classification of Gliomas
Official title: Search of Protein Biomarkers in Order to Achieve a Molecular Classification of Gliomas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glioblastoma
Keywords: High Grade Glioma
Proteomics
MALDI-MSI
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2015-06-16
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: high grade glioma

Brief summary: The aim is to classify high grade glioma by matrix-assisted laser desorption/ionization mass spectrometry imaging (MALDI MSI). In order to provide more specific informations for the diagnosis and the prognosis of high grade glioma.


Eligibility criteria: Main inclusion criteria:

* Patients with grade III or IV glioma newly diagnosed with histological evidence
* Surgical indication
* Tumor tissue available at biobank of Lille
* Men and women aged ≥ 18 years
* Informed Consent signed by the patient or his legal representative.

Main exclusion criteria:

* Antecedents of other cancers except basal cell skin cancer or carcinoma in situ of the uterus cervix
* Previous history of brain radiotherapy
* Anti-tumor systemic treatments (chemotherapy or targeted therapy) prior to surgery of glioma
* Genetic disease that may cause brain tumor, potentially radiation-induced tumor
* History of degenerative neurological disease prior to diagnosis
* contraindication to MRI

Primary outcomes:
measure: To evaluate the correlation between the WHO classification 2007 only established standard diagnostic and classification by mass spectrometry gliomas (lipids, peptides, proteins)
timeFrame: 2.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Le Rhun
Study officials:
affiliation: University Hospital, Lille
name: Emilie Le RHUN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05085184: Study to Evaluate the Safety and PK of UI018
Official title: A Randomized, Open, Single-dose, 2x2x4 Replicate Crossover-design Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Co-administration of UIC201806 and UIC201602 or Administration of UI018 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hyperlipemia, Mixed
Lead sponsor: Korea United Pharm. Inc.
Sponsor class: INDUSTRY
First posted: 2021-10-20
Enrollment: 44
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This Study is to evaluate the safety and pharmacokinetics of a fixed dose combination formulation and co-administration.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects between the ages of 19 and 45 years at screening
* Subjects whose body weight over 55 kg and ranged ± 20% of calculated Ideal body Weight(IBW) \[ IBW (kg) = (height(cm) - 100) x 0.9 \]
* Subjects able to read and understand a written informed consent, and willing to decide to participate in the study.

Primary outcomes:
measure: maximum concentration(Cmax)
timeFrame: 0 to 96 hrs
measure: area under the curve(AUC)
timeFrame: 0 to 96 hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
Study officials:
affiliation: Seoul National University College of Medicine and Hospital
name: Injin Jang, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03960684: Study of Colorectal Procedures With the Levita Magnetic Surgical System
Official title: Prospective Study of Colorectal Procedures With the Levita Magnetic Surgical System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Procedures
Lead sponsor: Levita Magnetics
Sponsor class: INDUSTRY
First posted: 2019-05-23
Enrollment: 31
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: The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System in patients undergoing colorectal procedures.

Detailed description: Prospective, multicenter, single-arm, open label study designed to assess the safety and effectiveness of the Levita Magnetic Surgical System in colorectal procedures.

Eligibility criteria: Inclusion Criteria:

* Subject is at least 18 years of age
* Subject is scheduled to undergo elective colorectal surgery

Exclusion Criteria:

* Significant comorbidities
* Subjects with pacemakers, defibrillators, or other electromedical implants
* Subjects with ferromagnetic implants
* Clinical history of impaired coagulation
* Subject has an anatomical abnormality noted after initiation of index procedure that would prevent device use
* Subject is not likely to comply with the follow-up evaluation schedule
* Subject is participating in another clinical trial

Primary outcomes:
measure: Number and Types of Tools Required to Retract the Colon or Peri-colorectal Tissues
timeFrame: During planned colorectal procedure
measure: Device Related Adverse Events
timeFrame: Through 30 days post colorectal procedure/study completion.
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital del Salvador
Study officials:
affiliation: The Cleveland Clinic
name: I. Emre Gorgun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03856684: Evaluation of Three Strategies Based on Vaginal Self-sampling Kit Send to Home of Unscreened Women for Cervical Cancer
Official title: Randomized Trial Evaluating Women's Behavior Not Participating in Cervical Cancer Screening Facing Three Strategies for Optimizing Home Sending by Post of Vaginal Self-sampling Kit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer Screening
Cervical Cancer
Keywords: vaginal
self-sampling
cervical cancer screening
Papillomavirus
HPV
High Risk Human papillomavirus Infection
pap smear
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
Collaborators: name: Centre Régional de Coordination des Dépistages des Cancers - Centre-Val de Loire
name: Centre d'Investigation Clinique-P1415, TOURS
First posted: 2019-02-27
Enrollment: 10400
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Despite the existence of an effective screening test (pap smear), cervical cancer is, every year in France, the cause of more than 3,000 new cases and 1,100 deaths. But, in France, 4 in 10 women are not screened or not often enough (nearly 7 millions women). It is therefore necessary to develop new strategies to reach these women. The etiological factor of this cancer is persistent infection with High-Risk Human PapillomaVirus (HR-HPV). Thereby, HPV-based tests could be alternative screening tests. Vaginal self-sampling with HR-HPV test is simpler and less intrusive than the pap smear. It has been shown that sending vaginal self-sampling kit (with HPV test) to unscreened women's home is a powerful means to increase the participation rate of cervical cancer screening. It seems interesting to explore methods to increase the efficiency of this strategy by optimizing the ratio of the number of kits used compared to the number of kits sent. Two approaches will be tested: a system "available on request" of the kit and / or the addition of an SMS (Short Message Service) reminder.


Eligibility criteria: Inclusion Criteria:

* women from 30 to 66 years old
* women living in french territorial division 37 ("Indre-et-Loire")
* women with a mobile phone in database
* women who do not perform a pap smear in the last 4 years
* women who do not answer to a first "invitation" letter to perform a pap smear

Exclusion Criteria:

* STOP SMS
* HPV cervical pathology during treatment
* Hysterectomy including cervix

Primary outcomes:
measure: Participation / no participation to complete cervical cancer screening
timeFrame: 9 months after postal mail (with or without the kit) or SMS
Secondary outcomes:
Other outcomes:
Locations:
city: Tours
country: France
facility: Crcdc-Cvl
Study officials:
affiliation: University Hospital of TOURS
name: Julie BOYARD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05389384: The Effect of a Passive Shoulder Exoskeleton and Muscle Fatigue on Occupational Work Performance
Official title: The Effect of a Passive Shoulder Exoskeleton and Muscle Fatigue on Occupational Work Performance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fatigue
Muscle Strain
Physical Stress
Keywords: peripheral fatigue
overhead work
task performance
ergonomics
effort
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 35
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: counterbalanced randomized cross-over study
Primary purpose: PREVENTION

Brief summary: In this investigation, participants perform simulated occupational work during which the task performance will be logged. This research investigates the effect of peripheral fatigue and a passive shoulder exoskeleton on the task performance.


Eligibility criteria: Inclusion Criteria:

* healthy (based on ParQ questionnaire)
* right handed

Exclusion Criteria:

* current musculoskeletal disorder
* history of recurrent musculoskeletal discorder

Primary outcomes:
measure: Work accuracy
timeFrame: During 2 minutes overhead work
measure: Work pace
timeFrame: During 2 minutes overhead work
Secondary outcomes:
measure: Surface electromyography
timeFrame: During 2 minutes overhead work
measure: Kinematic smoothness of movement
timeFrame: During 2 minutes overhead work
measure: Workload
timeFrame: After 2 minutes of overhead work
Other outcomes:
measure: Force output
timeFrame: before and after 4 minute during fatigue inducing protocol
Locations:
city: Brussel
country: Belgium
facility: Lichamelijk Opvoeding en Kinesitherapie
Study officials:
affiliation: Vrije Universiteit Brussel
name: Romain Meeusen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04602884: Early Detection of COVID-19 Using Breath Analysis
Official title: Early Detection of the 2019 Novel Coronavirus (SARS-CoV-2) Using Breath Analysis: First Cross-Sectional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Lead sponsor: Scentech Medical Technologies Ltd
Sponsor class: INDUSTRY
First posted: 2020-10-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: EARLY DETECTION OF COVID-19 USING BREATH ANALYSIS- FIRST CROSS-SECTIONAL STUDY

Detailed description: Primary objective- to identify and evaluate a set of biomarkers that represent both the genetic expression of the virus itself (SARS-CoV-2) and the metabolic activity of the immune system's response to the virus.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 55 years at the time of consent
* Positive results for SARS-CoV-2
* Capable of understanding written and/or spoken language
* Able to provide informed consent

Exclusion Criteria:

* Age under 18 years old
* (Anticipated) inability to complete breath sampling procedure due to e.g. hyper- or hypoventilation, respiratory failure, or claustrophobia when wearing the sampling mask
* Persons under guardianship or deprived of liberty
* Patients with the following diseases: Cancer, Asthma, Chronic Respiratory Disease
* Pregnant women
* Treated with antiviral drugs upon admission or during hospitalization
* Novices and soldiers in initial training

Primary outcomes:
measure: Correlation between Volatile Organic Compounds pattern and COVID-19 detection status.
timeFrame: Through the study completion, up to 3 months.
Secondary outcomes:
measure: Correlation between Volatile Organic Compounds pattern and time from COVID-19 detection.
timeFrame: Through the study completion, up to 3 months.
measure: Correlation between the set of Volatile Organic Compounds found in breath biopsy and disease intensity.
timeFrame: Through the study completion, up to 3 months.
Other outcomes:
Locations:
city: Ashkelon
country: Israel
facility: IDF COVID 19 Isolation Facility
Study officials:
affiliation: Scentech Medical Technologies Ltd
name: Natalie Dror, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00377884: Serologic Characterization of Bone-healing
Official title: Serologic Based Molecular Characterization of Bone-healing After Cementless Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Arthritis
Keywords: THA
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
Collaborators: name: CCBR Clinical Research Center, Aalborg, Denmark
First posted: 2006-09-19
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients planned for cementless THR for OA in the hip

Brief summary: Investigation of serologic bone markers in patients undergoing hip arthroplasty

Detailed description: Investigation of serologic bone markers in patients undergoing hip arthroplasty. Measured by frequent blood- and urine samples pre-operative and during the first post-operative year.

Eligibility criteria: Inclusion Criteria:

* Ages 40-80 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Northern Orthopaedic Division
state: Northern Jutland
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
Study officials:
affiliation: Northern Orthopaedic Division
name: Mogens B Laursen, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02538484: Impact of Omega 3 Fatty Acid Supplementation on Aromatase in Obese Subjects
Official title: A Phase 0, Investigator Initiated Study, Evaluating the Impact of Omega 3 Fatty Acid Supplementation on Aromatase in Obese Postmenopausal Women With Estrogen Receptor Positive Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2015-09-02
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Assess the impact of dietary omega 3 free fatty acids and/or letrozole on obese, postmenopausal breast cancer patients.

Detailed description: Prospective, comparative, three arm, short term, non-interventional study with correlative biomarker endpoints. Sixty (60) obese (≥ 30 BMI) newly diagnosed ER+ postmenopausal breast cancer patients will be recruited to participate in a short term (30 day) Phase 0 biomarker evaluation study prior to surgical resection.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age.
* Postmenopausal as confirmed in medical history
* Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB (Institutional Review Board)/Ethics Committee.
* Estrogen receptor positive breast cancer. Body mass index of 30 or greater.
* Consented for tissue collection on CTRC (Cancer Therapy and Research Center) repository 07-32

Exclusion Criteria:

* Cachexia
* Active systemic illness (infection including viral illnesses such as Hepatitis and HIV)
* Chronic use of NSAIDs (nonsteroidal anti-inflammatory drugs) aspirin or omega-3 free fatty acid supplementation within the last 60 days (defined as greater than or equal to 7 consecutive days)
* Any NSAIDs aspirin or omega-3 free fatty acid supplementation within the last 14 days
* History of medical noncompliance
* Scheduled date of surgical resection that would limit the amount of time taking the intervention to less than 21 days

Primary outcomes:
measure: Change in levels of aromatase target gene.
timeFrame: 30 Days
measure: Change in serum levels of PGE2 (prostaglandin E2).
timeFrame: 30 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Cancer Center at Texas Medical Center
state: Texas
city: San Antonio
country: United States
facility: Mays Cancer Center, UT Health San Antonio
state: Texas
Study officials:
affiliation: Principal Investigator
name: Andrew Brenner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: