louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04883125: Value of Using Pioglitazone in Chronic Myeloid Leukemia Treatment
Official title: Potential Utility of Peroxisome Proliferator-activated Receptor Gamma Agonists in the Eradication of Chronic Myeloid Leukemia Stem Cells: Myth or Truth?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Myelogenous Leukemia, BCR-ABL Positive
CML, Chronic Phase
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-05-12
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assessment of patients response and expression levels of CITED2 and HIF2a genes on adding pioglitazone to imatinib therapy.

Detailed description: Eligible denovo CML patients will be treated by combination drug therapy of imatinib 400 mg plus pioglitazone (15 - 30mg).They will be on follow up for their complete blood count (CBC), chemistry profile and random blood sugar every 2 weeks. After 3, 6 and 12 months of treatment the patients response will be evaluated and compared with the obtained responses of a historical control group. Assessment of the hypoxia induced factor 2 alpha (HIF2a) gene and CBP/p300-interacting transactivator with glutamic acid (E) and aspartic acid (D)-rich tail 2 (CITED2) gene expression levels before and after 6 months of treatment will be additionally evaluated.

Eligibility criteria: Inclusion Criteria:

* CML cases (BCR-ABL1 positive)

Exclusion Criteria:

* Accelerated or blastic crisis
* Atypical CML (BCR-ABL1 negative)
* Chronic myelomonocytic leukemia (CMML)
* Pregnant or breastfeeding females.
* Patients with severe organ dysfunction

Primary outcomes:
measure: Rate of major molecular response(MMR) at 12 months
timeFrame: 1 year
measure: Impact of treatment on the expression levels of stemness genes
timeFrame: 6 months
Secondary outcomes:
measure: Impact of treatment on the rate of transformation
timeFrame: 1 years
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of Medicine
state: Dakahlia
Study officials:
affiliation: Oncology Center Mansoura University
name: Mohamed N. Mabed, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00158925: The EASYTRAK EPI Clinical Investigation
Official title: The EASYTRAK EPI Clinical Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bradycardia
Congestive Heart Failure
Keywords: Artificial Cardiac Pacing
Implanted Electrodes
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 100
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 assess the safety and effectiveness of the EASYTRAK EPI lead.

Detailed description: This is a prospective, single-armed, multi-center U.S., Australian, Canadian, and European clinical investigation, designed to demonstrate the safety and effectiveness of the EASYTRAK EPI lead in humans.

Eligibility criteria: Inclusion Criteria:

* Patients who meet the EASYTRAK EPI indications
* Patients who are age 18 or above, or of legal age to give informed consent specific to state and national law
* Patients who are willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigational center and at the intervals defined by this protocol
* Patients who meet any one of the following three conditions:

  * Meet current indications for cardiac resynchronization therapy (CRT) and epicardial placement of a pace/sense lead on the left ventricle is preferred over an endocardial lead
  * Meet current indications for a cardiac pacing system and have documented evidence that an endocardial lead cannot be used
  * Meet current indications for a cardiac pacing system and a concurrent cardiac surgical procedure is taking place where no additional surgical procedures are required to provide access to the epicardial surface of the heart

Exclusion Criteria:

* Patients who meet the EASYTRAK EPI contraindications
* Patients who have had a myocardial infarct, unstable angina, or percutaneous coronary intervention during the preceding 30 days prior to enrollment
* Patients with a documented life expectancy of less than 6 months or expected to undergo heart transplant within the next 6 months
* Patients enrolled in any concurrent study, without Guidant written approval, that may confound the results of this study
* Women who are pregnant or plan to become pregnant

Primary outcomes:
measure: Chronic Pacing Thresholds at 3 Months
timeFrame: 3 months
measure: Chronic Pacing Impedances at 3 Months
timeFrame: 3 months
measure: Chronic Sensing Amplitudes at 3 Months
timeFrame: 3 months
measure: Lead-related Complication-free Rate at 3 Months
timeFrame: 3 months
Secondary outcomes:
measure: Lead Implant Time
timeFrame: Implant
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Multiple Locations in the US
state: Minnesota
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Daniel Beckman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06847425: Sphenopalatine Ganglion Block with Bupivacaine and Its Effect on Pain After Functional Endoscopic Sinus Surgery
Official title: Sphenopalatine Ganglion Block with Bupivacaine and Its Effect on Pain After Functional Endoscopic Sinus Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anaesthesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Functional endoscopic sinus surgery (FESS) is a minimally invasive procedure that is used in many inflammatory and infectious sinus diseases. Acute postoperative pain can lead to adverse consequences and good postoperative treatment of pain is essential. There is no agreement on a single protocol to treat pain after endoscopic sinus surgeries, and the usually used analgesics have some side effects that hinder their use. Current evidence is insufficient for routine clinical use of the sphenopalatine ganglion block for Functional endoscopic sinus surgery and the efficacy of sphenopalatine ganglion block for pain control after functional endoscopic sinus surgery remains controversial. This study aims to explore the influence of sphenopalatine ganglion block on pain intensity after functional endoscopic sinus surgery by comparing two groups, a group receiving the block with Bupivacaine injection, versus saline injection in the other group.


Eligibility criteria: Inclusion Criteria:

1. Age: 18 years - 80 years.
2. ASA I and ASA II patients.
3. Consented to participate in the research.

Exclusion Criteria:

1. Pregnant and breastfeeding females.
2. History of allergy to bupivacaine or other local anaesthetics.
3. Patients with uncontrolled hypertension, poorly controlled cardiovascular diseases, or cerebrovascular diseases.
4. Patients with pre-existing neurological conditions.
5. Patients with history of alcohol or drug abuse.
6. Patients on anticoagulation.
7. Occurrence of surgical or anaesthetic complications or change in the anaesthesia protocol.
8. Patients showing sensitivity to Bupivacaine.
9. Patients unable to understand VAS score.
10. Patients refusing to continue participating in the study.

Primary outcomes:
measure: Mean Visual Analogue Scale (VAS) pain score over the first 24 hours postoperatively.
timeFrame: in the PACU, at 2, 6, 12, and 24 hours after surgery
Secondary outcomes:
measure: Time to first rescue analgesia
timeFrame: 24 hours postoperatively
measure: Total requirements of rescue analgesia
timeFrame: 24 hours postoperatively
measure: Number of patients receiving rescue analgesia
timeFrame: 24 hours postoperatively
measure: Incidence and severity of adverse effects and complications
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT06144125: Prothrombin Complex Concentrate vs Fresh Frozen Plasma in Goal-directed Bleeding Management in Cardiac Surgery
Official title: Prothrombin Complex Concentrate and Fresh Frozen Plasma in Viscoelastic Test-based Goal-directed Bleeding Management in Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Cardiac Valve Disease
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 152
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are randomly divided into two groups (experimental vs control groups).
Primary purpose: TREATMENT

Brief summary: The primary endpoint of this study is the completion time of hemostasis treatment when administered Fresh frozen plasma (FFP) and frozen powder coagulation factor concentrate (PCC) in goal-directed bleeding management for cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* patients undergoing cardiac surgery

Exclusion Criteria:

* thrombocytopenia
* oral anti-coagulant
* anti platelet agents

Primary outcomes:
measure: treatment time
timeFrame: 1 min
Secondary outcomes:
measure: Red Blood Cell amount
timeFrame: I hour
measure: FFP amount
timeFrame: 1 hour
measure: Platelet amount
timeFrame: 1 hour
measure: CT-EXTEM
timeFrame: 10 min
measure: MA-EXTEM
timeFrame: 10 min
measure: MA-FIBTEM
timeFrame: 10 min
measure: Postoperative bleeding
timeFrame: 24 hour
Other outcomes:
Locations:
Study officials:
affiliation: Konkuk University Medical Center
name: Tae-Yop Kim, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02224625: Irritation and Sensitization of Chlorhexidine Gluconate (CHG) Cloth
Official title: Randomized and Observer-blinded Study to Evaluate the Cumulative Irritation and Contact Sensitizing Potential of One Finished Test Product
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Surgery
Lead sponsor: Medline Industries
Sponsor class: INDUSTRY
First posted: 2014-08-25
Enrollment: 249
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluating the irritation properties of CHG cloth. Some Subjects will also have the product applied to see if they become sensitized to repeated applications.

Detailed description: For the Irritation Study (30 subjects), patches containing CHG, vehicle, saline, CHG comparator or sodium lauryl sulfate (a product that is expected to produce a slight skin irritation) will be placed on the same spot of your skin every day for 21 days. The skin will be examined every day.

The Sensitization Study (200 total subjects) place patches containing CHG, vehicle, saline, CHG comparator on the skin 3 times a week for 3 weeks. Following a two-week rest period the patches will be reapplied for 48 hours and assessed out to 72 hours thereafter.

Eligibility criteria: Inclusion Criteria:

* Free of skin disorders
* Signed consent

Exclusion Criteria:

* Allergies to latex
* Topical or systemic steroids, antihistamines, antiinflammatory agents 7 days prior or during testing
* severe illness
* Pregnant (females)

Primary outcomes:
measure: Grading Scale for Visual Evaluation of Skin Condition
timeFrame: 21 Days for Irritation (N=39). 35 Days for Sensitization (N=249)
Secondary outcomes:
Other outcomes:
Locations:
city: Butte
country: United States
facility: BioScience Laboratories
state: Montana
Study officials:
affiliation: BioScience Laboratories
name: J Pullman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05888025: MBCT-T for Preoperative Pain Catastrophizing and Pain Outcomes After Spine Surgery
Official title: A Pilot Proof of Concept, Single-Center Study of the Effects of Telephone-Delivered Mindfulness-based Cognitive Therapy (MBCT-T) on Preoperative Pain Catastrophizing and Pain Outcomes After Spine Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a two phase study. In phase 1, a focus group (N=5) will be conducted to adapt MBCT-T for use in the study population. In phase 2, a single-arm trial will be conducted examining four, weekly sessions of preoperative MBCT-T in subjects with high pain catastrophizing scheduled for spine surgery (N=20). Subjects will then be followed for two weeks postoperatively.


Eligibility criteria: Inclusion Criteria:

* Scheduled for one or two level lumbar spine surgery requiring an inpatient stay as well as patients having ambulatory 1 or 2 level lumbar spine surgeries
* PCS score ≥ 20
* Able to provide voluntary informed consent
* Telephone access
* Internet access

Exclusion Criteria:

* Non-English speaking
* Cognitively impaired, by history
* Bipolar disorder
* Borderline personality disorder
* Active post-traumatic stress disorder
* Schizoaffective disorder or any other disorder characterized by delusions or hallucinations
* History of self-harm or suicidality in past three months

Primary outcomes:
measure: Percentage of Participants who Attend More than Half of Scheduled Sessions
timeFrame: Up to Week 8 (End of Intervention)
measure: Client Satisfaction Questionnaire (CSQ-8) Score
timeFrame: Week 8 (End of Intervention)
Secondary outcomes:
measure: Change in Pain Catastrophizing Scale (PCS) Score
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Lisa Doan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03366025: Progesterone Variation on the Final Day of Oocyte Maturation.
Official title: Progesterone Variation on the Final Day of Oocyte Maturation. A Prospective Cohort Study With Repeated Measurements
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Controlled Ovarian Stimulation
Progesterone Variation on Trigger Day
Circadian Rhythm
Oocyte Donors
Lead sponsor: Fundacion Dexeus
Sponsor class: OTHER
First posted: 2017-12-08
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy oocyte donors according to spanish law for oocyte donation

Brief summary: The current study, aims through a robust design to provide a simple answer on whether progesterone levels of the same individual may significantly vary depending on the time of blood retrieval before the ovulation triggering, by evaluating the daily variability of serum progesterone on the day of triggering in healthy women who perform a COS for oocyte donation, through multiple blood samplings.


Eligibility criteria: Inclusion Criteria:

* Healthy oocyte donors according to spanish law for oocyte donation
* Controlled ovarian stimulation following a flexible antagonist protocol and stimulation with recombinant Follicular stimulating hormone.
* Informed consent signed

Exclusion Criteria:

* Detection of luteinizing hormone surge before triggering

Primary outcomes:
measure: Progesterone variation among 4 different moments on the day of ovulation triggering
timeFrame: Progesterone will be measured 4 times on the day of ovulation triggering, each of them separated 4 hours from the previous one (total 4 samples within 12 hours): blood samples will be obtained at 8:00 am, 12:00 pm, 4:00 pm and 08:00 pm
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Salud de la Mujer Dexeus
Study officials:
References:
citation: Gonzalez-Foruria I, Rodriguez I, Martinez F, Rodriguez-Purata J, Montoya P, Rodriguez D, Nicolau J, Coroleu B, Barri PN, Polyzos NP. Clinically significant intra-day variability of serum progesterone levels during the final day of oocyte maturation: a prospective study with repeated measurements. Hum Reprod. 2019 Aug 1;34(8):1551-1558. doi: 10.1093/humrep/dez091.
Clinical trial NCT01565525: Anticipatory Guidance to Prevent Childhood Obesity
Official title: Can Changing How Moms Eat Prevent Obesity in Toddlers?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: well child visit
anticipatory guidance
obesity prevention
infant feeding
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2012-03-28
Enrollment: 306
Sex: ALL
Minimum age (years): 2
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this pilot project is to test anticipatory guidance, which is information given to families during a well child visit to prevent obesity during childhood. The objectives were to compare two styles of anticipatory guidance during the first year of life, maternal focused and infant focused, versus usual care and determine which style, if any, showed the most ideal infant feeding behaviors at age 1 year and to see if there were any differences in infant weight for height at one year of age. The investigators hypothesized that mothers who received the maternal focused anticipatory guidance (which gave information on eating family meals, not having tv on during meals, and maternal nutrition) would actually have the best infant feeding behaviors and weight for height of infants at one year.


Eligibility criteria: Inclusion Criteria:

Maternal/infant pairs Infant under 2 months of age Mother English speaking

Exclusion Criteria:

History of Neonatal ICU stay in infant Gestation less than 37 weeks in infant chronic disease in infant known genetic disorder in infant foster care placement in infant

Primary outcomes:
measure: Infant weight for height
timeFrame: One year after study entry
Secondary outcomes:
measure: Maternal feeding behaviors
timeFrame: One year after study entry.
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital, Columbus Ohio
name: Judith Groner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Groner JA, Skybo T, Murray-Johnson L, Schwirian P, Eneli I, Sternstein A, Klein E, French G. Anticipatory guidance for prevention of childhood obesity: design of the MOMS project. Clin Pediatr (Phila). 2009 Jun;48(5):483-92. doi: 10.1177/0009922809331799. Epub 2009 Feb 25.
citation: Nicholson LM, Schwirian PM, Klein EG, Skybo T, Murray-Johnson L, Eneli I, Boettner B, French GM, Groner JA. Recruitment and retention strategies in longitudinal clinical studies with low-income populations. Contemp Clin Trials. 2011 May;32(3):353-62. doi: 10.1016/j.cct.2011.01.007. Epub 2011 Jan 27.
citation: French GM, Nicholson L, Skybo T, Klein EG, Schwirian PM, Murray-Johnson L, Sternstein A, Eneli I, Boettner B, Groner JA. An evaluation of mother-centered anticipatory guidance to reduce obesogenic infant feeding behaviors. Pediatrics. 2012 Sep;130(3):e507-17. doi: 10.1542/peds.2011-3027. Epub 2012 Aug 13.
Clinical trial NCT05321225: The Level of Blood Brain Barrier Damage Biomarker in Acute Ischemic Stroke
Official title: The Level of Blood Brain Barrier Damage Biomarker Predicting Hemorrhagic Transformation Following Acute Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Stroke
Keywords: blood brain barrier
hemorrhagic transformation
ischemic stroke
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute ischemic stroke patients received standard therapy within 24-hour since stroke onset

Brief summary: Hemorrhagic transformation is a common complication of acute ischemic stroke patients . BBB damage is regarded as a major pathophysiological mechanism of hemorrhagic transformation. So, the investigators hypothesis the level of BBB damage biomarker is predictor of intracranial hemorrhage following ischemic stroke.

Detailed description: Hemorrhagic transformation is a common complication of acute ischemic stroke patients . BBB injury often occurs in the early stage of ischemic stroke, leading brain tissue edema or even hemorrhagic transformation with the development of ischemic injury. The biomarker of BBB damage, such as the level of serum occludin, can reflect the extent of BBB injury. So, the investigators hypothesis the level of BBB damage biomarker is predictor of intracranial hemorrhage following ischemic stroke.

Eligibility criteria: Inclusion Criteria:

1. Enrolled patients aged 18-80years.
2. Acute ischemic stroke
3. Informed consent obtained.

Exclusion Criteria:

1. Tumor stroke or hemorrhagic stroke or hemorrhagic cerebral infarction on admission.
2. Stroke or serious head trauma within the previous 3 months
3. inflammatory or infectious diseases, cancer, coagulation disturbance disease and severe renal and liver failure
4. blood sample occurred hemolysis or cloudy.
5. Incomplete clinical data
6. Platelet count of less than 100,000 per cubic millimeter
7. Received oral anticoagulation therapy preceding the onset of stroke and INR greater than 1.7 or prothrombin times greater than 15 seconds
8. Pregnant or breast-feeding women
9. Patients being enrolled or having been enrolled in other clinical trial -

Primary outcomes:
measure: The change of serum biomarkers within 72h in ischemic stroke patients
timeFrame: Day 0, Day 1, Day 2, Day 3.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijin
country: China
facility: Xuanwu hospital;Capital Medical University
state: XI Cheng District
Study officials:
affiliation: Xuan Wu Hospital,Capital Medical University
name: Ke Jian Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References: