louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00952328: Effect of Early Limited Formula Use on Breastfeeding Outcomes
Official title: Effect of Early Limited Formula Use on Breastfeeding Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Keywords: breastfeeding outcomes
breastfeeding self-efficacy
infant weight loss
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Stanford University
First posted: 2009-08-06
Enrollment: 40
Sex: ALL
Minimum age (years): 24
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to conduct a pilot randomized controlled trial of the effect of early limited formula supplementation on breastfeeding-related outcomes for infants with high early weight loss. The investigators will enroll 40 exclusively breastfeeding infants at 24-48 hours of age and will randomly assign them to early limited formula supplementation following nursing (intervention group) or to no formula feeding (control group). Both groups will receive intensive lactation support. Outcome variables will include breastfeeding status on day-of-life 8, weight nadir, breastfeeding self-efficacy, maternal satisfaction, and exclusive and partial breastfeeding at 1-3 months. The hypothesis for this study is that early limited formula supplementation might help infants with early weight loss avoid eventual weight loss ≥ 10% and associated breastfeeding problems.


Eligibility criteria: Inclusion Criteria:

* Healthy term infants (37 to 42 weeks gestation)
* Infants who have lost 5% of their birth weight at \<36 hours of age

Exclusion Criteria:

* Infants who have received formula or water
* Mothers who are producing mature milk supply
* Infants receiving Level II or Level III care other than healthy term infants with routine complete blood count and blood tests pending

Primary outcomes:
measure: Is infant receiving exclusively breast milk at 8 days of life?
timeFrame: 8 days following baseline
Secondary outcomes:
measure: Is infant receiving exclusive or partial breastfeeding at 1 month, 2 months, and 3 months?
timeFrame: 1-3 months following baseline
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco Medical Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Valerie Flaherman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02071628: Study for Validation of In-vitro Turbidometric Platelet Aggregation Assay Using Human Blood in Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Validation of In-vitro Turbidometric Platelet Aggregation Assay
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2014-02-26
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adult voulteers

Brief summary: This study is designed for validation of in-vitro platelet aggregation assay using human blood in healthy volunteers. 32ml blood, 2ml for complete blood count test and 30ml for platelet aggregation assay, was collected from ten subjects, respectively.

Preparation of Platelet Rich Plasma (PRP):

1. Collect human blood using 21g butterfly syringe and dilute 9:1 into 3.8% sodium citrate vacutainer vials.
2. Prepare platelet rich plasma (PRP) by centrifuging blood at 100 x g for 15 minutes at room temperature. Using a plastic transfer pipette, carefully transfer and combine PRP from multiple vacutainer tubes (if required) into a 15 mL conical tube.
3. PRP is removed re-centrifuge remaining blood in vacutainer tubes at 2000 x g for 15 minutes at room temp. to obtain platelet poor plasma (PPP). Transfer PPP to 15 mL conical tube.
4. Measure platelet count in combined PRP using Z1 Coulter Particle Counter or similar product. Adjust platelet count to a final concentration of 300,000 +- 10,000 platelets in PRP using PPP.

Aggregation Measurement:

Aggregation is measured using a model 490-X Chrono-Log Aggregometer or similar product. PPP is used as a reference to establish 100% optical transmission.


Eligibility criteria: Inclusion Criteria:

* 20-50years old
* must be able to consent voluntarily
* consent to keep the study terms of obedience

Exclusion Criteria:

* blood coagulation disorder or bleeding disorder
* blood donation within 60 days or blood transfusion within 30 days before screening
* smoker or who stopped smoking within 1month before screening
* administration of drugs such as anticoagulants or antiplatelets or alcohol within 14 days before screening
* eligibility failure under investigator's judgements

Primary outcomes:
measure: Maximal platelet aggregation(MPA) for the TRAP and 5-HT baseline aggregation response and the 5-HT amplification of TRAP-induced aggregation
timeFrame: Up to 6months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02914028: TAP Block and Subacute Pain in Inguinal Herniography
Official title: Evaluation of the Effects of Subcostal Transversus Abdominis Plane Block on Subacute Pain Development Following Inguinal Herniography: a Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: TAP block
subacute pain
inguinal herniography
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2016-09-26
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Inguinal hernia repair with mesh has a high incidence of postoperative chronic pain. Transversus abdominis plane block is a current intervention to support postoperative analgesia, however it is recently in research area how to be applied in different surgical areas to be more effective than intravenous opioids. Subcostal transversus abdominis plane block is not advised but has not been studied to be effective for postoperative analgesia in inguinal herniography patients.

This study aims to research the effect of subcostal transversus abdominis plane block in subacute postoperative pain after inguinal hernia repair

Detailed description: Patients were divided into two groups, one is control and the second is subcostal transversus abdominis plane block (STAP) group. After standard general anesthesia application, control group ( Group I) had 1 gram of paracetamol and 100 mg of contramal just after starting surgical closure. Group II (STAP) had 1 gram of paracetamol and 100 mg of contramal, after surgical closure transversus abdominis plane block in subcostal area was applied to the patient.

Eligibility criteria: Inclusion Criteria:

* ASA I-III
* who were to undergo elective unilateral inguinal herniography with "mesh" under general anesthesia.

Exclusion Criteria:

* patients who have allergy to local anesthetics

Primary outcomes:
measure: verbal numeric scale
timeFrame: 1 month after the operation
Secondary outcomes:
measure: verbal numeric scale
timeFrame: 15 minutes, 1-6-12-24 hours and 15 days after operation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00294528: Comparing Clinical Outcome of 2 Different Total Knee Prostheses: Nexgen LPS-Flex Versus AGC
Official title: Comparing Clinical Outcome of 2 Different Total Knee Prostheses: Nexgen LPS-Flex and AGC
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Keywords: osteoarthritis, knee
total knee arthroplasty
range of motion
satisfaction
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2006-02-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized blinded study is conducted comparing 2 different knee prostheses. Range of motion (ROM), pain, feel of prosthesis, satisfaction and ability to do daily activities are registered at intervals up to one year postop, where patients are informed on which prosthesis they received.

We want to:

* determine whether an increased ROM is achieved with a high-flex knee compared to a standard knee
* and if so, does it matter

Detailed description: 100 patients operated on with unilateral TKR are included and randomized to either prostheses.

Patients operated on with bilateral simultaneous TKR receive one of each prostheses but are blinded to which prosthesis is on which side. They have gait analyses performed preop and at intervals up to one year.

Eligibility criteria: Inclusion Criteria:

* age below 75 years and active
* preop ROM at least 120 degress flexion
* BMI below 30
* intact ligaments

Exclusion Criteria:

* below 18 years
* unable to understand language or purpose

Primary outcomes:
measure: ROM
measure: Pain
measure: Satisfaction
measure: Feel of prosthesis
measure: Gait analysis
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: orthopedic department, section of arthroplasty, Hvidovre University Hospital
state: Hvidovre
Study officials:
affiliation: head of arthroplasty section
name: Henrik Husted, consultant
role: PRINCIPAL_INVESTIGATOR
affiliation: arthroplasty section
name: Kristian Stahl Otte, consultant
role: PRINCIPAL_INVESTIGATOR
affiliation: Head nurse of arthroplasty section
name: Gitte Holm, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: nurse
name: Helle Krogshøj Hansen, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thomsen MG, Husted H, Otte KS, Holm G, Troelsen A. Do patients care about higher flexion in total knee arthroplasty? A randomized, controlled, double-blinded trial. BMC Musculoskelet Disord. 2013 Apr 8;14:127. doi: 10.1186/1471-2474-14-127.
Clinical trial NCT05826028: Mayzent (Siponimod) Onboarding of Secondary Progressive Multiple Sclerosis (SPMS) Patients With MSGo
Official title: Mayzent (Siponimod) Onboarding of Secondary Progressive Multiple Sclerosis (SPMS) Patients With MSGo
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Secondary Progressive Multiple Sclerosis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-04-24
Enrollment: 368
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study

Brief summary: This study was a retrospective, non-interventional, longitudinal, descriptive study. This study did not have a key underlying hypothesis, rather it was designed to explore the onboarding and adherence of SPMS patients in Australia to Mayzent (siponimod) treatment.

Initiating siponimod involves pre-screen tests, including a CYP2C9 genotype test to determine siponimod maintenance dosing, and patients underwent a 6-day titration prior to maintenance. The MSGo platform was developed to support onboarding. It is an integrated digital platform that functions as a patient support service.


Eligibility criteria: Inclusion criteria

* Adult patients with SPMS as per the treating physician's clinical assessment (Therapeutic Goods Administration \[TGA\]-approved indication of Mayzent).
* Expanded Disability Status Scale (EDSS) of 3.0 to 6.5 (inclusive).
* Patients accessing Mayzent via the Mayzent Experience Program (MEP) must have met the MEP criteria, and if available, the Pharmaceutical Benefits Scheme (PBS) restrictions recommended by the Pharmaceutical Benefits Advisory Committee (PBAC).
* Patients accessing Mayzent via the PBS must have met the PBS restrictions.

Exclusion criteria

* Patients who were contraindicated for Mayzent treatment according to the TGA-approved Product Information.
* Patients diagnosed with clinically isolated syndrome or primary progressive multiple sclerosis (MS).

Primary outcomes:
measure: Average time for siponimod onboarding
timeFrame: Up to 168 days
Secondary outcomes:
measure: Time to siponimod onboarding in pre-specified sub-groups
timeFrame: Up to 168 days
measure: Percentage of patients who adhered to the titration protocol
timeFrame: Up to 168 days
measure: Time on maintenance therapy
timeFrame: Up to 168 days
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Novartis Investigational Site
state: New South Wales
city: St Leonards
country: Australia
facility: Novartis Investigational Site
state: New South Wales
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02140528: Allogeneic Mesenchymal Stem Cell Transplantation in Tibial Closed Diaphyseal Fractures
Official title: Evaluation the Safety and Efficacy of Allogeneic Mesenchymal Stem Cell Transplantation in Tibial Closed Diaphyseal Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tibial Fracture
Keywords: Allogenic adipose derived mesenchymal stem cell tibial fracture
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2014-05-16
Enrollment: 40
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: This study is a case-control prospective, clinal trial to assess the safety and efficacy of the allogeneic adipose derived mesenchymal stem cell transplantation on the healing of recent tibial fracture in 40 patients.

Detailed description: In this study all eligible patients divided in 2 group.20 patients received allogeneic adipose derived mesenchymal stem cell in the fractured site (case group) and other patients received the placebo in the fractured site (control group) .

To assess the outcomes, we will evaluate the patients at 2, 6 weeks and 3, 6 months after transplantation by: X-ray, BMD , VAS and biochemical analysis with laboratory tests.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 65 years
* The presence of tibial fracture based on X ray
* tibial fracture is limited to diaphysial

Exclusion Criteria:

* Addiction
* Pregnancy
* liver or kidney disease or uncontrolled diabetes or heart and lung disease
* immune deficiency

Primary outcomes:
measure: Number of patients with union after transplantation of mesenchymal stem cell in case group in comparison with control group
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Head of Royan Institute
name: Hamid Gourabi, PhD
role: STUDY_CHAIR
affiliation: Head of regenerative medicine department &cell therapy center of Royan Institute
name: Nasser Aghdami, MD,PhD
role: STUDY_DIRECTOR
affiliation: Department or regenerative medicine of Royan Institute.
name: Mohsen Emaddedin, MD
role: STUDY_DIRECTOR
affiliation: Scientific board of Iranian Orthopedic Association
name: Aziz Ahmadi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Regenerative Medicine
name: Maedeh Ghorbani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Scientific board of Iranian Orthopedic Association
name: Afshin Farhadi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06559228: ConnectedNest: a Digital Platform Connecting Individuals With Cancer to Social Care
Official title: ConnectedNest: a Digital Platform Connecting Individuals With Cancer to Social Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cancer
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Social determinants of health (SDoH) such as housing instability, food insecurity, and financial burden largely shape the health and well-being of individuals, create health inequities, and drive a large portion of avoidable adverse health outcomes and healthcare costs. With new advancements in treatment and rising out-of-pocket expenses, individuals facing cancer are especially vulnerable to the adverse effects of SDoH. To address these barriers, a novel solution is needed to support oncology patients, clinical teams, and community-based organizations (CBOs) across the cancer continuum. In a Phase I contract award, XanthosHealth developed ConnectedNest, a novel electronic social care referral platform to screen for SDoH needs and connect individuals with cancer to social and community services provided by CBOs while engaging the oncology team in the SDoH referral process. Through additional funding, a pilot study was completed in Minneapolis, Minnesota, in partnership with Minnesota Cancer Alliance, involving the collaboration of 14 CBOs focused on cancer. 50 cancer survivors from these CBOs were enrolled to utilize the ConnectedNest platform for a 90-day duration. Our study involved the collection and analysis of crucial metrics related to patient and CBO engagement, SDoH needs, and the volume of feasible social care referrals. In Phase II, the technical features and integration capabilities of ConnectedNest will be enhanced based on learnings in Phase I and completed pilot study. The platform will be implemented and tested among patients seen at multiple oncology clinics, evaluating health outcomes of patients who use the platform.


Eligibility criteria: Inclusion Criteria:

* Adults, age 18 and over
* undergoing active cancer therapy or in survivorship
* must be able to read and write in English
* Seen in a participating Minnesota oncology clinic

Exclusion Criteria:

* Children

Primary outcomes:
measure: Number of self-reported social needs
timeFrame: Day 90
measure: Reported social needs that are partially or completely met
timeFrame: Day 90
Secondary outcomes:
measure: Number of connections with needed social and community services with needed social and community services
timeFrame: Day 90
measure: Quality of life
timeFrame: Day 90
measure: Satisfaction with Care
timeFrame: Day 90
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Helen Parsons, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05290428: DNA PAX1 and JAM3 Methylation for Cervical Cancer Screening
Official title: The Accuracy of Host DNA PAX1 and JAM3 Methylation for Cervical Cancer Screening: a Multi-center, Double-blind, Parallel Controlled Clinical Trials
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Cancer
Cervical Intraepithelial Neoplasia
DNA Methylation
Cancer Screening
Detection Accuracy
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Zhejiang Provincial People's Hospital
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
First posted: 2022-03-22
Enrollment: 459
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants will accept surgeries harvesting cervical histology.

Brief summary: Based on the previous study of NCT03961191 and NCT03960879, we performed this trial to further confirm the accuracy of host DNA PAX1 and JAM3 methylation for cervical cancer screening. This study would provide profound basis for the approval of assay kit of DNA methylation in China for cervical screening. Three hospitals, including Peking Union Medical College Hospital, would enroll eligible patients in this study. The cervical cytology of 3 ml will be collected for the detection of DNA PAX1 and JAM3 methylation, and the results will compared with the cervical histological pathology, which is achieved after collection of cervical cytology, by surgeries including loop electrosurgical excision procedure, cervical conization, total hysterectomy and others. The methylation testing would be double-blinded in operators and analysts. The retrospective and prospective parts will enroll at least 120 patients and at least 339 patients, respectively.


Eligibility criteria: Inclusion Criteria:

* With uterine cervix intact
* Aged 18 years or older
* With accessible histological results of cervix
* Signed an approved informed consents
* With accessible cervical cytology before harvesting cervical histology

Exclusion Criteria:

* Not meeting all of the inclusion criteria

Primary outcomes:
measure: Sensitivity of methylation testing
timeFrame: One week
measure: Specificity of methylation testing
timeFrame: One week
Secondary outcomes:
measure: Positive predictive value of methylation testing
timeFrame: One week
measure: Negative predictive value of methylation testing
timeFrame: One week
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05696028: Comparison of Different Gfr Measurements in Chronic Kidney Diseases
Official title: Resident Doctor at Clinical Pathology Departement
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Kidney Diseases
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 166
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients proven or suspected CKD

Brief summary: Comparison of different Gfr measurements in Chronic Kidney Diseases

Detailed description: Comparison of gfr measured by different method as radionuclide method and creatinine clearance

Eligibility criteria: Inclusion Criteria:

* patients with proven or suspected CKD who will be referred to nuclear medicine departement of Assuit University hospital and will undergo dynamic renal imaging.

Exclusion Criteria:

* Severely ill patients
* Disturbed conscious level
* Patients on dialysis
* patients have oedema or ascites

Primary outcomes:
measure: Is to Compare gfr measured by radionuclide method to gfr measured by creatinine clearance in patients with CKD
timeFrame: 1year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Asmaa Zidan, doctor
role: PRINCIPAL_INVESTIGATOR
References: