louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03074292: Comparison Between Effect of Conventional, Intensive and Light Emitting Diodes (LED) Phototherapy on Oxidative Stress Among Neonates With Unconjugated Hyperbilirubinemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oxidative Stress
Neonatal Hyperbilirubinemia
Phototherapy Complication
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-03-08
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to test a hypothesis assuming that phototherapy might have an effect on oxidant/antioxidant status in term and late-preterm neonates with unconjugated hyperbilirubinemia.


Eligibility criteria: Inclusion Criteria:

* Term and late-preterm neonates (≥35weeks) according to the guidelines of the American Academy of Pediatrics (2004) which stated that gestational ages of newborns were determined according to the first day of the mother's last menstrual period (by the mother's statement) and were additionally confirmed by the Ballard scoring system (Ballard et al., 1991) and antenatal ultrasonographic estimation or obstetric records if present.
* Clinical significant indirect hyperbilirubinemia requiring phototherapy in the first week of life.
* Normal blood counts and peripheral blood smears
* Normal reticulocytic count.
* Breast fed newborn.

Exclusion Criteria:

* Those in whom the total serum bilirubin (TSB) level rose by more than 5 mg/dl per day or was higher than 20 mg/dl within the first 24 hours after birth were excluded from the study.
* Infant of diabetic mothers.
* Maternal eclampsia-preeclampsia.
* Birth asphyxia
* Sepsis
* congenital anomalies.
* Direct Coombs'test positive
* Pathological causes of hyperbilirubinemia.
* Enclosed hemorrhage.
* Hemolytic type of hyperbilirubinemia due to blood group or Rh incompatibility.

Primary outcomes:
measure: Effect of types of phototherapy on change in total antioxidant capacity (TAC)
timeFrame: 2 days
measure: Effect of types of phototherapy on change in malonaldehyde (MDA)
timeFrame: 2 days
measure: Effect of types of phototherapy on change in nitric oxide (NO)
timeFrame: 2 days
Secondary outcomes:
measure: Effect of types of phototherapy on change in serum iron (Fe)
timeFrame: 2 days
measure: Effect of types of phototherapy on change in serum copper (Cu)
timeFrame: 2 days
measure: Effect of types of phototherapy on change in serum zinc (Zn)
timeFrame: 2 days
measure: Effect of types of phototherapy on change in serum calcium (Zn)
timeFrame: 2 days
Other outcomes:
Locations:
Study officials:
References:
citation: El-Farrash RA, El-Shimy MS, Tawfik S, Nada AS, Salem DAD, M Gallo MS, Abd-Elmohsen EW. Effect of phototherapy on oxidant/antioxidant status: a randomized controlled trial. Free Radic Res. 2019 Feb;53(2):179-186. doi: 10.1080/10715762.2018.1549364. Epub 2019 Mar 1.
Clinical trial NCT06382792: Osteolysis of Allograft Prosthetic Composite After Shoulder Resection for Tumors
Official title: Results of Proximal Humeral Reconstruction With Allograft Prosthetic Composite After Resection for Tumors
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Shoulder Disease
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 6
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: All patients treated for tumors of proximal humerus, who underwent a Malawer type I resection of this tumors

Brief summary: The gold standard after shoulder resection for tumors is reconstruction by reverse prosthesis and allograft. This is an intervention also performed for more frequent etiologies (revisions of prosthesis, non cancerous humeral bone loss ...).

The results in these etiologies are good, and do not find any particular mechanical complications (including no osteolysis of the graft). In the case of reconstruction for cancer, the numbers of patients are lower (rare pathologies) and some studies on small numbers found osteolysis of the allograft. The aim of this study is to analyze the presence or not osteolysis in these patients, and to quantify it precisely by scanner measurement (no data yet in the literature).

Detailed description: quantify bone stock of the allograft by scanner measurement in post operative and in 6 month to 1 years after surgery.

This is a retrospective study, and the scanner was performed routinely every 3 to 6 month, during 2 years, for oncological follow up.

Eligibility criteria: Inclusion Criteria:

* tumors of proximal humerus
* Malawer type I resection
* primary reconstruction by allograft prosthetic composite

Exclusion Criteria:

* resection and reconstruction by prosthesis alone
* resection and reconstruction by prosthesis and cement sleeve reconstruction
* resection and reconstruction by hemiarthroplasty
* revision protheses.

Primary outcomes:
measure: Osteolysis (bone stock in cm3)
timeFrame: within 3 months post operatively and up to 1 year post operatively
Secondary outcomes:
measure: Constant score
timeFrame: up to 1year post operatively
measure: Complications
timeFrame: up to 1year post operatively
measure: Revision
timeFrame: up to 1year post operatively
Other outcomes:
Locations:
city: Nancy
country: France
facility: Central Hopital
Study officials:
affiliation: Central Hopital, Nancy France
name: Sirveaux FRANCOIS
role: STUDY_CHAIR
References:
Clinical trial NCT01659892: Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fed Conditions
Official title: A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Montelukast Sodium 5 mg Chewable Tablets Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Asthma
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2012-08-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to prove the bioequivalence of Montelukast Chewable Tablet under fed conditions


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to montelukast or any comparable or similar product.

Primary outcomes:
measure: bioequivalence determined by statistical comparison Cmax
timeFrame: 9 days
Secondary outcomes:
Other outcomes:
Locations:
city: Fargo
country: United States
facility: PRACS Institute, Ltd.
state: North Dakota
Study officials:
affiliation: PRACS Institute, Inc.
name: Alan K Copa, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06354192: Precision Nudging for Hypertension Management: Observational Study
Official title: Data-driven Personalization for Inclusive Outreach and Equitable Outcomes in a Digital Health Intervention for Hypertension Management: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypertension
Keywords: Medication adherence
Self-monitoring of blood pressure
Clinical encounters
Health equity
Precision nudging
Digital health intervention
Behavioral reinforcement learning
Lead sponsor: Lirio
Sponsor class: INDUSTRY
Collaborators: name: Cone Health
First posted: 2024-04-09
Enrollment: 12000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This observational study will follow participants enrolled in a digital health intervention for hypertension management at one of nine Cone Health Community Access Clinics.

Brief summary: The purpose of the proposed observational study is to explore the relations between data-driven personalization and equitable health outcomes in a digital health intervention (DHI) for hypertension management. In the current intervention, behavioral reinforcement learning is applied to personalize intervention content to maximize the behavioral outcomes of three target behaviors critical for effective hypertension management: clinical encounters, medication adherence, and self-monitoring of blood pressure (SMBP).


Eligibility criteria: Inclusion Criteria:

* Patient of Cone Health.
* Hypertension condition considered "uncontrolled" (signaled by an eligibility indicator).
* Most recent blood pressure reading is at or higher than 160/90.

Exclusion Criteria:

* Non-English speaking.
* Globally unsubscribed.
* Locally unsubscribed.
* Deceased.

Primary outcomes:
measure: Clinical encounter behavioral outcome
timeFrame: 0-18 months
measure: Blood pressure reading clinical outcome
timeFrame: 0-18 months
Secondary outcomes:
measure: Engagement
timeFrame: 0-18 months
measure: Medication adherence behavioral outcome
timeFrame: 0-18 months
measure: Self-monitoring of blood pressure behavioral outcome
timeFrame: 0-18 months
Other outcomes:
Locations:
city: Greensboro
country: United States
facility: Cone Health clinics
state: North Carolina
Study officials:
References:
Clinical trial NCT03937492: EFFECTIVENESS OF GRADED MOTOR IMAGERY TO PREVENT CRPS IN PATIENTS WITH DISTAL RADIUS FRACTURE AFTER SURGERY
Official title: EFFECTIVENESS OF GRADED MOTOR IMAGERY TO PREVENT CRPS IN PATIENTS WITH DISTAL RADIUS FRACTURE AFTER SURGERY: A RANDOMIZED CONTROLLED TRIAL
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wrist Fracture
CRPS (Complex Regional Pain Syndromes)
Distal Radius Fracture
Surgery
Keywords: GMI
CRPS
Distal radius fracture
Lead sponsor: Ergoterapia Manoegomito Sagl
Sponsor class: OTHER
First posted: 2019-05-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study would like show that patients who follow a protocol with GMI are less probability to develop CRPS

Detailed description: Distal radius fractures (DRF) has a high frequency in adults. Studies show that the upper limb is frequently affected by CRPS, especially if is preceded by a fracture.

Recent studies suggest that changes in cortical structures can contribute to the onset of CRPS.

GMI is a approved and efficacy method in CRPS rehabilitation, because it trains modified cortical areas throught 3 stadies: left-right discrimination, visual motor imagery and mirror therapy.

Literature shows that there are any studies about GMI efficacy on prevention CRPS in DRF after surgery.

This study would like to demostrate that, appling GMI in the early stages of rehabilitation plus standard rehabilitation protocol of DRF after surgery, CRPS cases are reducted.

Eligibility criteria: Inclusion Criteria:

* Patients with distal radius fracture after surgery
* 18 to 75 years old
* Male and female

Exclusion Criteria:

* uncompliants patients
* patients with neurological disorders or cognitive impairment
* patients with TFCC injury or both ulna and radius fractures
* patients with visually impairment
* patients who don't speak or understand oral and written italian language

Primary outcomes:
measure: Range Of Motion
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Patient-rated wrist/hand evaluation (prwhe)
timeFrame: Baseline and 8 weeks
measure: Jamar hand dynamometer
timeFrame: Baseline and 8 weeks
measure: McGill pain questionnaire
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Ergoterapia Manoegomito Sagl
name: Susanna Pagella
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01788592: Prospective Evaluation of Drug-Eluting Stents in Routine Clinical Practice (ASAN PCI Registry)
Official title: Prospective Evaluation of Drug-Eluting Stents in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
drug eluting stent
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2013-02-11
Enrollment: 50000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: consecutive patients amenable to percutaneous coronary intervention with drug eluting stents

Brief summary: The objective of this study is to evaluate effectiveness and safety of drug-eluting stent implantation in the "real world" daily practice.


Eligibility criteria: Inclusion Criteria:

* coronary disease amenable to percutaneous coronary intervention (PCI)
* no clinical and lesion limitations

Exclusion Criteria:

* patients with a mixture of several drug eluting stents
* terminal illness with life expectancy less than 1 year
* patients with cardiogenic shock

Primary outcomes:
measure: Major Adverse Cardiac Event
timeFrame: 1year
Secondary outcomes:
measure: all cause Death
timeFrame: 1year
measure: Myocardial Infarction
timeFrame: 1year
measure: The composite of Death or myocardial infarction
timeFrame: 1year
measure: Any repeat revascularization
timeFrame: 1year
measure: Target vessel revascularization
timeFrame: 1year
measure: Target lesion revascularization
timeFrame: 1year
measure: New lesion revascularization
timeFrame: 1year
measure: Stent thrombosis by Academic Research Consortium criteria
timeFrame: 1year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Seung-Jung Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park SJ, Ahn JM, Park GM, Cho YR, Lee JY, Kim WJ, Han S, Kang SJ, Park DW, Lee SW, Kim YH, Lee CW, Mintz GS, Park SW. Trends in the outcomes of percutaneous coronary intervention with the routine incorporation of fractional flow reserve in real practice. Eur Heart J. 2013 Nov;34(43):3353-61. doi: 10.1093/eurheartj/eht404. Epub 2013 Oct 2.
Clinical trial NCT00180492: Post-Approval Study of the Guidant Carotid Stent Systems and Embolic Protection Systems: CAPTURE
Official title: Carotid RX ACCULINK(TM)/ACCUNET(TM) Post-Approval Trial to Uncover Unanticipated or Rare Events - CAPTURE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerotic Disease, Carotid
Keywords: Atherosclerotic disease
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
Collaborators: name: Guidant Corporation
First posted: 2005-09-16
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This purpose of this study is to collect data on the FDA-approved ACCULINK(TM) Carotid Stent System and FDA 510(k)-cleared ACCUNET(TM) Embolic Protection System for the treatment of patients with atherosclerotic disease, when used by physicians under commercial use conditions.

Detailed description: CAPTURE is a post-approval study to collect information on the safety and effectiveness of the ACCULINK and ACCUNET since the approval/clearance of these devices by the FDA. The ACCULINK stent is an elastic-like metal tube that is used to hold open a narrow part of a blood vessel. The ACCUNET is a wire mesh basket that is placed in the vessel to catch material (blood clots, fatty material) that could break off from the narrowed area of the blood vessel and block blood flow downstream during the stent procedure.

Another goal of the CAPTURE study is to confirm that the ACCULINK and ACCUNET can be used safely by physicians with varying levels of experience in stenting procedures.

The basis for FDA's approval/clearance of the ACCULINK and ACCUNET was the ARCHeR trials (ACCULINK/ACCUNET for Revascularization of Carotids in High-Risk Patients). The ARCHeR trials were conducted to collect data on the safety and effectiveness of the ACCULINK and ACCUNET when used in the treatment of carotid artery disease in patients at high risk for surgical treatment (carotid endarterectomy) because of medical or surgical comorbidities. The ARCHeR trials showed that the ACCULINK, used with or without the ACCUNET, is a safe and effective treatment option based on the rate of death, stroke, and myocardial infarction at 30 days, and stroke at one year.

Eligibility criteria: Inclusion Criteria:

* Patient's physician used an ACCULINK and/or ACCUNET

Primary outcomes:
measure: Death, stroke, and myocardial infarction at 30 days post-procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Clara
country: United States
facility: Guidant Corporation
state: California
Study officials:
affiliation: Abbott Medical Devices
name: Gary A Walker, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06803992: Induction of Labor - Comparison Propess with Prostaglandin E2 Vaginal Gel and Balloon Catheter
Official title: Induction of Labor in Women with Unfavorable Cervix At Term - Comparison of Propess Versus Prostaglandin E2 Vaginal Gel and Extra-amniotic Balloon Catheter
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Induction of Labor
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: One of every four births in the Western world is induced, usually due to the risk of maternal and fetal morbidity. There are several methods of labor induction, pharmacological and mechanical. In cases of unfavorable cervix (Bishop score is below 5), cervical ripening can be induced by either prostaglandins E2 (slow release 10 mg dinoprostone insert (propess) or vaginal gel 1-2 mg) or mechanically by Foley catheter balloon (FCB).

The efficacy of labor induction of propess versus vaginal gel combined with FCB was not studied previously.

The goal of this randomized controlled trial is to compare the efficacy of propess versus PGE2 vaginal gel combined with FCB in women with singletons undergoing labor induction at term. The main question it aims to answer is to compare the time from the beginning of labor induction until delivery.


Eligibility criteria: Inclusion Criteria:

* Pregnant women at term (37 weeks of gestation or more) with singleton
* pregnancies that are intended for IOL.
* Initial bishop score \<5
* No contraindications to receive either treatment.
* Women who will give informed consent to be included in the study.
* Women at or over the age of 18.

Exclusion Criteria:

* Women with a known hypersensitivity or contraindications to Propess / PGE2.
* Parity 5 or more
* Labor contractions more than 4 in 20 min
* Glaucoma
* History of previous uterine surgery
* Hypersensitivity to prostaglandins
* Vaginal delivery is contraindicated
* Active cardiac, renal, pulmonary, or hepatic disease
* Severe asthma or pulmonary disease

Primary outcomes:
measure: comparing the duration of induction-to-vaginal delivery
timeFrame: from enrollment until final outcome - a month
Secondary outcomes:
measure: rate of vaginal delivery in 24 and 48 hours from IOL
timeFrame: from enrollment until final outcome - a month
measure: Number of Participants with Treatment-Related Adverse Events
timeFrame: from enrollment until final outcome - a month
measure: rate of Induction success
timeFrame: from enrollment until final outcome - a month
measure: rate o Cervical ripening success
timeFrame: from enrollment until final outcome - a month
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Emek medical center
Study officials:
affiliation: Emek Medical Center
name: Zohar Nachum, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01360892: Prediction of Incidence of Liver Cancer by Use of Real-time Tissue Elastography
Official title: Prediction of Incidence of Liver Cancer or PorTal Hypertension in Patients With Viral Hepatitis by Use of Real-time Tissue Elastography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Hepatitis B
Chronic Hepatitis C
Keywords: Hepatitis B virus
Hepatitis C virus
Chronic hepatitis
Liver chlorosis
Liver stiffness
Liver fibrosis
Lead sponsor: Kindai University
Sponsor class: OTHER
First posted: 2011-05-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with chronic hepatitis B or C will be eligible for the study. Subjects with other infectious viral diseases or chronic liver disease are excluded for study enrollment.

Real-time Tissue Elastography®, serum maker and gastrointestinal endoscopy are performed. If in the hopsital they can perform FibroScan®, FobroScan® also be performed.

The time between the Real-time Tissue Elastography®, blood sampling, FiroScan® must not exceed four weeks.

Brief summary: This is a multi-center cohort study in which the Real-time Tissue Elastography® measurements will predict prospectively the incidence of hepatocellular carcinoma, the incidence and severity of gastroesophageal varices ascites and decompensated cirrhosis in hepatitis B or C patients.

Detailed description: The aim of this study is to validate the predictive value of Real-time Tissue Elastography® by comparison with serum marker or FibroScan® in chronic hepatitis B or C patients.

Every year and for three years, we performed Real-time Tissue Elastography®, blood sampling, gastrointestinal endoscopy. If in the hospital they can perform FibroScan®, FobroScan® also be performed.

Subjects were also performed ultrasonography (US), computed sonography (CT) or magnetic resonance imaging (MRI) evry four or six months.

The time between the Real-time Tissue Elastography®, blood sampling, gastrointestinal endoscopy and FiroScan® must not exceed four weeks.

Eligibility criteria: Inclusion Criteria:

* Male or female and at least 20 years of age
* Chronic hepatitis B or Chronic hepatitis C

Exclusion Criteria:

* Evidence or history of hepatocellular carcinoma
* History of alcohol abuse (alcohol intake \> 20g/day)
* Pregnant or lactating patients
* Psychosis

Primary outcomes:
measure: Cumulative incidence of carcinogenesis of hepatocellular carcinoma
timeFrame: every four or six months
Secondary outcomes:
measure: Cancer-free survival
timeFrame: every four or six months
measure: Overall survival
timeFrame: one year
measure: The cumulative incidence and severity of gastro-esophageal varices
timeFrame: one year
measure: The cumulative incidence and severity of decompensated cirrhosis
timeFrame: one year
Other outcomes:
Locations:
city: Osaka-sayama
country: Japan
facility: Kinki University Faculty of Medicine
state: Osaka
Study officials:
affiliation: Kinki University Faculty of Medicine
name: Masatoshi Kudo, Professor
role: STUDY_CHAIR
References: