louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06865443: Evaluation of CD47, "Do Not Eat Me" Signal Expression in Chronic Myeloid Leukemia
Official title: Evaluation of CD47, "Do Not Eat Me" Signal Expression in Chronic Myeloid Leukemia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Myeloid Leukemia (CML)
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: CML patients, who fulfill the WHO 2022 criteria

Brief summary: Chronic myeloid leukemia is a myeloid neoplasm characterized by the overproduction of mature granulocytes . Cluster of differentiation 47 (CD47) is a membrane protein, which is over-expressed by virtually all cancers and regulates many signaling systems associated with tumor growth and invasion. Following CD47 binding to the inhibitory receptor (signal regulatory protein, SIRPα) on macrophages, the CD47-receptor complex sends a "do not eat me" anti-phagocytic signal to prevent phagocytosis . This balance is tipped by cancer cells, which adopt the "self" signal and upregulate CD47 expression to evade immune surveillance and subsequent destruction. Elevated expression of CD47 has been observed in ovarian carcinoma cell lines , murine myeloid leukemias , leukemic stem cells and several solid tumors .

Flow cytometry revealed high surface expression of CD47 on 73% of samples collected from the bone marrow of multiple myeloma (MM) patients .

High CD47 expression on six different primary effusion lymphoma (PEL) cell lines compared to peripheral blood mononuclear cells (PBMC) was found . Additionally, in acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and several non-Hodgkin's lymphoma (NHL) subtypes, increased CD47 expression is correlated with adverse clinical outcomes .

Hematological malignancies, even at onset, present with widespread bone marrow and peripheral blood involvement and many are still without effective systemic curative therapies . Most CML patients have deep and durable responses when treated with BCR::ABL1 tyrosine kinase inhibitors, which might be influenced by long-term toxicities during the treatment .

CD47 "don't eat me signal" expression not evaluated in CML. the aim of the study To detect CD47 expression by flow cytometry in CML patients. To study the correlation between BCR::ABL1 gene and CD47 expression in CML patients . Evaluation of the role CD47 as predictor of CML patient outcome


Eligibility criteria: Inclusion Criteria:

* age more than 18 years
* both sex
* CML patients, who fulfill the WHO 2022 criteria

Exclusion Criteria:

* Patients with other haematological neoplasms (ALL,CLL, plasma cell myeloma)

Primary outcomes:
measure: CD47 Signal Expression in Chronic Myeloid Leukemia
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04230343: Limits of the Social Benefit Motive Among High-risk Patients: a Field Experiment on Influenza Vaccination Behaviour
Official title: Limits of the Social Benefit Motive Among High-risk Patients: a Field Experiment on Influenza
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza Vaccine
Behavioral Intervention
Self-benefit
Social-benefit
Lead sponsor: SB Istanbul Education and Research Hospital
Sponsor class: OTHER
Collaborators: name: University of Nottingham
First posted: 2020-01-18
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Influenza vaccine uptake remains low worldwide, inflicting substantial costs to public health and health systems. Messages promoting social welfare have been shown to increase vaccination intentions, and it has been recommended that health professionals communicate the socially beneficial aspects of vaccination. This study aims to provide the first test whether this prosocial vaccination hypothesis applies to the actual vaccination behaviour of high-risk patients by comparing the effects of two motivational messages for promoting vaccination at a tertiary care public hospital in Istanbul, Turkey.


Eligibility criteria: Inclusion Criteria:

* Patients hospitalized at medical departments of the hospital who are on the day of discharge

Exclusion Criteria:

* Egg ellergy
* Previous allergic reaction to influenza vaccine
* Pregnancy
* Cognitive disability

Primary outcomes:
measure: Vaccine uptake following the introduction of the pamphlet
timeFrame: On the same day, upto 24 hours
Secondary outcomes:
measure: Vaccine uptake in high and low risk group patients following the introduction of the pamphlet
timeFrame: On the same day, upto 24 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: SB Istanbul Training and Research Hospital
Study officials:
References:
citation: Isler O, Isler B, Kopsacheilis O, Ferguson E. Limits of the social-benefit motive among high-risk patients: a field experiment on influenza vaccination behaviour. BMC Public Health. 2020 Feb 17;20(1):240. doi: 10.1186/s12889-020-8246-3.
Clinical trial NCT05265143: Comparision of Two Different Feeding Method in Preterms
Official title: Comparision of Two Different Feeding Method in Preterm Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Enteral Feeding Intolerance
Keywords: preterm
feeding intolerence
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: achievement of optimal postnatal growth by adequate enteral nutrition in critically ill preterm infants is a challenge of NICU. signs like abdominal distension, reflux, vomiting, nec is a factors of discontinuing fedding in preterm. this factors plays a role in decisions about which method of gavage feeding is adopted. we compare two different feeding method to achive less fedding tolerence.

Detailed description: \<1750 gr, \<33 gw infants will enroll study. exckusion criteria: major congenital anomalies major gis anomalies

The study infants are enrolled within 24 hours of birth and sequently randomized to either intermitten feeding (IF) and bolus feeding (BF). Intermittent feeding is defined as delivering enteral nutrition and generally giving 60 min and 2 hours no feeding. this circle repeats 8 times in 24 hours. Bolus feeding is the amount of nutrition put into the syringe was kept 10 cm above the baby and the fluidity was obtained by gravity through the orogastric tube. The data of the patients such as feeding intolerance (gastric residual volume more than %50 of the previous feeding volume, gastric regurgitation, abdominal distension and/or emesis ), whether there is a week-by-week feeding intolerance were noted, NEC, time to reached birth weight, time to achieved full enteral feeding, every 5 minutes during feeding, saturation, respiratory rate and heart rates will record.

Eligibility criteria: Inclusion Criteria:

* \<1750 gr preterm infants
* \<33 gw
* admitted to our nicu in first day of life

Exclusion Criteria:

major congenital anomalies gis anomalies septic shock exitus in 3 days of life

-

Primary outcomes:
measure: rate of feeding intolerence
timeFrame: 1 month
Secondary outcomes:
measure: time to reach full enteral feeding
timeFrame: 1 month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Ümraniye Teaching Hospital
Study officials:
affiliation: Zekai Tahir Burak Women's Health Research and Education Hospital
name: Funda Yavanoğlu Atay, md
role: PRINCIPAL_INVESTIGATOR
References:
citation: Richards R, Foster JP, Psaila K. Continuous versus bolus intermittent intragastric tube feeding for preterm and low birth weight infants with gastro-oesophageal reflux disease. Cochrane Database Syst Rev. 2021 Aug 6;8(8):CD009719. doi: 10.1002/14651858.CD009719.pub3.
Clinical trial NCT05817643: Food Effect Study of BMS-984923 in Healthy Older Adult Volunteers
Official title: A Randomized, Open-label, 2-period, Crossover, Pilot Food Effect Study of BMS-984923 in Healthy Older Adult Volunteers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Alzheimer Disease
Dementia
Lead sponsor: Allyx Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
First posted: 2023-04-18
Enrollment: 12
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This project is developing a novel disease-modifying compound for Alzheimer's disease (AD).

Detailed description: The primary objective of this study is to evaluate for an effect of food consumption on the pharmacokinetics profile of BMS984923. Safety and tolerability is also assessed.

Eligibility criteria: Inclusion Criteria:

* Men or women between the ages of 50 and 80 years, inclusive
* No history of cognitive impairment
* Capable of providing written informed consent and willing to comply with all study requirements and procedures
* Participant is not pregnant, lactating, or of childbearing potential

Exclusion Criteria:

* Body mass index (BMI) \>38 kg/m2 or body weight \<50 kg.
* Significant cerebrovascular disease
* Any significant neurologic disease
* A current Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM V) diagnosis of active major depression, schizophrenia or bipolar disorder
* Clinically significant or unstable medical condition
* Any disorder or medication that could interfere with the absorption, distribution, metabolism or excretion of drugs
* History of cholecystectomy
* History of acute/chronic hepatitis B or C and/or carriers of hepatitis B (seropositive for hepatitis B surface antigen \[HbsAg\] or anti-hepatitis C virus \[HCV\] antibody).
* Use of psychoactive medications
* Use of medications with potential drug-drug interactions
* Use of another investigational agent
* Clinically significant abnormalities in screening laboratories
* Any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale
* Acceptable Geriatric Depression Scale (GDS) score

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax)
timeFrame: Up to 10 days after last dose
measure: Time of Cmax (Tmax)
timeFrame: Up to 10 days after last dose
measure: Area Under the Curve from 0 to 24h (AUC 24h)
timeFrame: Up to 10 days after last dose
Secondary outcomes:
measure: Incidence of Treatment Emergent Adverse Events (TEAE)
timeFrame: 14 days
measure: Safety Laboratory abnormalities
timeFrame: 14 days
measure: Electrocardiogram - QT Interval
timeFrame: 14 days
Other outcomes:
Locations:
city: West Bend
country: United States
facility: Spaulding Clinical Research
state: Wisconsin
Study officials:
affiliation: Principal Investigator
name: Stephanie Post, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05358743: Effect of Probiotics on Oral Candida Among Denture Wearers
Official title: Effect of Probiotics on Oral Candida Colonization Level in Complete Denture Wearers (Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oral Candida Albicans Infection
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-05-03
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Forty-eight denture wearers with detectable levels of candida colonization without clinical symptoms will be randomly allocated into two groups: probiotics and placebo. All patients will take a daily dose of chewable tablets (probiotics or placebo according to the assigned group) for 8 weeks. Samples of mouth rinse will be collected from patients at baseline, 4 weeks from the beginning of the intervention, 8 weeks (the end of intervention), and after another 4 weeks for post-intervention follow up. Samples will be tested for both candida count and candida species identification


Eligibility criteria: Inclusion Criteria:

* Detectable levels of Candida in palatal mucosa without clinical symptoms of active candidiasis.
* Completely edentulous arches with newly formed denture .
* Patients with controlled hypertension, and diabetes will be included in this study as they are considered very common problems in the targeted population.

Exclusion Criteria:

* Inability to understand/ follow the experimental procedures,
* Administration of topic or systemic antifungal or antibacterial agents in the previous 60 days.
* Consumption of probiotics.
* GITdisorders.
* Heartdisease.
* Diseases that significantly influence immunity such as; kidney problems, head and neck cancer, or radiotherapy, AIDS, or immunosuppressive therapy.
* Clinical manifestations of oral candidiasis.

Primary outcomes:
measure: Change in candida count
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
References:
Clinical trial NCT01630343: Pain Management in Geriatric Hip Fracture
Official title: The Efficacy of Pain Management Protocol for Elderly Hip Fracture Patients After Surgery: A Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Geriatric Hip Fracture Pain Management
Keywords: Geriatric hip fracture
pain management
Lead sponsor: Queen Elizabeth Hospital, Hong Kong
Sponsor class: OTHER
First posted: 2012-06-28
Enrollment: 400
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Null Hypothesis is that there is no association between Pain regime and the functional performance among geriatric patients having traumatic hip fracture. Two limbs are being assessed:1. Three weeks of regular oral Panadol and Tramadol after hip fracture 2. Oral Panadol and tramadol taking in p.r.n. basis. Functional outcome including Numerical Rate Scale for pain assessment, Functional Independency Measure and Elderly Mobility Score are chosen.

Detailed description: 200X2 patients are recruited during two periods within the study period where regular oral analgesics is given for the first 200 patients while the rest of patient will receive oral analgesics upon demand

Eligibility criteria: Inclusion Criteria:

* Both sex of Age \> 65
* Traumatic non-pathological fracture neck of femur or trochanteric or subtrochanteric fracture having operative intervention

Exclusion Criteria:

* Age \< 65
* Pathological fracture
* Multiple lower limb fractures
* Old fracture

Primary outcomes:
measure: Functional Independency Measure(FIM)
timeFrame: 2 years
measure: Elderly Mobility Score
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong SAR
country: China
facility: Department of Orthopaedics and Traumatology, Queen Elizabeth Hospital
Study officials:
affiliation: The Queen Elizabeth Hospital
name: Chin Ping Hong, Raymond, FRCSE(Edin)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03434743: Non-nutritive Sucking and Breastfeeding in Preterm Infants
Official title: Effect of Non-nutritive Sucking on the Breast to Enhance Breastfeeding in Infants Who Are Born Prematurely
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant,Premature
Infant Development
Infant, Very Low Birth Weight
Keywords: oral feeding
early intervention
premature infant
sucking
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2018-02-15
Enrollment: 33
Sex: ALL
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to assess whether non-nutritive sucking on an emptied breast will lead to more success with direct breastfeeding than non-nutritive sucking on a pacifier in preterm infants.

Detailed description: Breast milk is vital in the nourishment of premature infants. Early interventions which focus on enhancing infants' oral motor skills required for breastfeeding are needed. There is very limited evidence on early interventions aimed at maintaining rudimentary sucking skills needed for breastfeeding in this high risk population. The main objective of this study is to assess whether non-nutritive sucking on an emptied breast will enhance breast feeding performance in preterm infants.

The target population will consist of clinically stable preterm infants born less born less than or equal to 34 weeks gestational age and whose mother's intention are to breastfeed. Infants will be randomized into the non-nutritive sucking on emptied breast or pacifier group. Both interventions will be administered by mothers. Time to transition to full oral feeding, breastfeeding acquisition at hospital discharge and breastfeeding duration at six months of age will be monitored.

Eligibility criteria: Inclusion Criteria:

* born less than or equal to 34 weeks gestational age (GA);
* appropriate size for their GA;
* receiving nasal continuous positive airway pressure;
* receiving only enteral feedings (orogastric or nasogastric);
* mothers are pumping their milk.

Exclusion Criteria:

* congenital anomalies
* mother not expressing milk
* transferred in hospital

Primary outcomes:
measure: Number of days to transition from full tube to full oral feeds
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Breastfeeding acquisition at hospital discharge
timeFrame: Through study completion, an average of 2 years
measure: Breastfeeding duration
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Queen's University
state: Ontario
Study officials:
References:
citation: Fucile S, Wener E, Dow K. Enhancing breastfeeding establishment in preterm infants: A randomized clinical trial of two non-nutritive sucking approaches. Early Hum Dev. 2021 May;156:105347. doi: 10.1016/j.earlhumdev.2021.105347. Epub 2021 Mar 10.
Clinical trial NCT06362343: The Study of Monitoring and Dosing Guidance of Direct Oral Anticoagulants Based on Pharmacokinetics, Pharmacodynamics, and Pharmacogenomics
Official title: The Study of Monitoring and Dosing Guidance of Direct Oral Anticoagulants Based on Pharmacokinetics, Pharmacodynamics, and Pharmacogenomics
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Embolism
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Ruijin Hospital
name: Xiangya Hospital of Central South University
name: China-Japan Friendship Hospital
First posted: 2024-04-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with pulmonary embolism and are using DOACs.

Brief summary: 1. Integrate pharmacokinetic-pharmacodynamic (PK-PD) modeling and pharmacogenomics techniques to develop a population PK-PD model, aiming to explore monitoring and dose guidance schemes for Direct Oral Anticoagulants (DOACs).
2. Investigate the factors influencing PK-PD of DOACs in the pulmonary embolism population, clarifying the correlation between genotype characteristics and clinical outcomes.
3. Explore the correlation between drug concentrations, coagulation indices, and clinical outcomes of DOACs, defining the indications for DOACs testing and the overall monitoring process.


Eligibility criteria: Inclusion Criteria:

* Adult patients with acute symptomatic pulmonary embolism objectively diagnosed by imaging (with or without deep vein thrombosis) who have completed anticoagulation for the acute phase and have entered the maintenance phase of anticoagulation
* Expected lifespan greater than 3 months
* Eligible for the use of Xa factor inhibitors;
* Agreement to participate in the study, signing of informed consent, and commitment to regular follow-up.

Exclusion Criteria:

* Moderate or severe liver dysfunction (Child-Pugh grade B or C);
* Severe renal impairment (CrCl \< 15 ml/min);
* Pregnant or breastfeeding women;
* Tendency for spontaneous bleeding, such as coagulopathy or thrombocytopenia (PLT \< 20×10\^9/L);
* Contraindications for the use of other Xa factor inhibitors;
* Patients diagnosed with hereditary thrombophilia and antiphospholipid syndrome.

Primary outcomes:
measure: Bleeding events
timeFrame: Through the entire follow-up time, 3 months
measure: Recurrent thromboembolic events
timeFrame: Through the entire follow-up time, 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Juhong Shi, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04929743: Randomized Clinical Trial to Evaluate the Predictability of 5.5 mm Dental Implants
Official title: Randomized Clinical Trial to Evaluate the Predictability and Evolution of Extra-short 5.5 mm Dental Implants Splinted in Partial or Complete Prostheses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Partial-edentulism
Lead sponsor: Fundación Eduardo Anitua
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main aim of this clinical trial is to analyze the survival rate of short-length implants (\<4.5 mm) in partial edentulism subjects. 6.5 mm length implants will be used as control arm. Additionally, others clinical parameters (marginal bone loss and prosthetic associated complications) will be measured.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Clinical indication to place a prosthetic bridge supported by a maximum of 4 implants in the posterior sectors
* Bone height in the area of interest sufficient to place implants 6.5mm length dental implants
* Availability to be observed during the follow-up period
* Signature of the informed consent

Exclusion Criteria:

* Need to perform bone augmentation surgery prior to implant placement surgery
* Smokers (\> 10 cigarettes per day)
* Patients with poorly controlled diabetes
* Patients on chronic treatment with non-steroidal anti-inflammatory drugs
* Patients receiving oral or intravenous bisphosphonates
* Patients under chemotherapy or radiotherapy treatment
* Patients receiving systemic corticosteroids

Primary outcomes:
measure: Survival of implants
timeFrame: 1 year
Secondary outcomes:
measure: Marginal bone loss
timeFrame: 1 year
measure: Incidence of bleeding on probing
timeFrame: 1 year
measure: Incidence of prosthetic or implant complications
timeFrame: 1 year
measure: Probing pocket depth
timeFrame: 1 year
Other outcomes:
Locations:
city: Vitoria
country: Spain
facility: Clinica Eduardo Anitua
Study officials:
References: