louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00352261: An Open Label pH Comparison of Esomeprazole and Lansoprazole in Barrett's Esophagus Patients
Official title: An Open-Label, 2-Way Crossover Study of Steady-State Intragastric pH Control Comparing 2 Dosage Regimens of Esomeprazole and Lansoprazole in Barrett's Esophagus Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Barrett's Esophagus
Keywords: Barrett's Esophagus
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-07-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare the treatment of esomeprazole 40 mg once daily and lansoprazole 30 mg once daily in controlling intragastric pH in Barrett's Esophagus patients


Eligibility criteria: Inclusion Criteria:

* Documented history (within 2 yrs of histologically proven BE;
* Aged 18-70 (inclusive);
* Willing and able to comply with all study procedures

Exclusion Criteria:

* Signs of clinically significant GI bleeding within 3 days prior to randomization;
* History of gastric or esophageal surgery;
* Clinically significant illness within 2 weeks prior to first dose of study drug or during study

Primary outcomes:
measure: Compare pharmacodynamic efficacy of esomeprazole 40 mg & lansoprazole 30 mg once daily in controlling intragastric pH in Barrett's Esophagus patients by evaluation of the percentage of time that intragastric pH is >4.0 over a 24 hr period steady state
Secondary outcomes:
measure: Compare pharmacodynamic efficacy of esomeprazole 40 mg & lansoprazole 30 mg bid in controlling intragastric pH in BE patients by evaluation of the % of time intragastric pH is >4.0 over 24 hr period at steady state
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: North Chicago
country: United States
facility: Research Site
state: Illinois
city: Rochester
country: United States
facility: Research Site
state: Minnesota
city: Kansas City
country: United States
facility: Research Site
state: Missouri
city: Springfield
country: United States
facility: Research SIte
state: Missouri
city: Butte
country: United States
facility: Research Site
state: Montana
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Knoxville
country: United States
facility: Research Site
state: Tennessee
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Norfolk
country: United States
facility: Research Site
state: Virginia
Study officials:
affiliation: AstraZeneca
name: Debra Silberg, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02765061: Hyponatremia and Hypoalbuminemia is Morbimortality Predictors in Coronary Artery Bypass Graft Surgery
Official title: Hyponatremia and Hypoalbuminemia is Morbimortality Predictors in Coronary Artery Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Hyponatremia
Hypoalbuminemia
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2016-05-06
Enrollment: 1157
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with coronary artery disease

Brief summary: Coronary artery disease is a common medical disease in many populations. The pathogenesis of this disease is very complex. Surgery is one of the treatment choices. Assessing the risk factors will improve the surgical outcome. In this study some biochemical parameters were evaluated to find out the relationship between these parameters (electrolytes and albumin vs)


Eligibility criteria: Inclusion Criteria:

* Patients who underwent coronary artery bypass graft surgery
* Elective surgery

Exclusion Criteria:

* Pediatric patients
* Off-pump surgery
* Emergent surgery

Primary outcomes:
measure: myocardial infarction
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02108561: Breast Cancer Tumor Heterogeneity
Official title: Does Breast Tumor Heterogeneity Necessitate Additional HER2 Testing on the Surgical Specimens?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: Breast Cancer Heterogeneity Her2
Lead sponsor: Anne Arundel Health System Research Institute
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2014-04-09
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Breast Cancer pre-surgical patients

Brief summary: Breast cancer biomarkers are usually performed on core needle biopsy (CNB) specimens and are not routinely repeated on surgical specimens (SS). However, preliminary data suggests that testing these biomarkers, on SS when compared to CNB samples can lead to different results. Our hypothesis is that The aim of this study is to identify a group of women with invasive breast cancer who may benefit from additional HER2 testing on their SS to ensure that areas of HER2 amplification are not missed. Another aim is to determine whether further HER2 testing on the SS in select patients would lead to changes in breast cancer treatment options.


Eligibility criteria: Inclusion Criteria:

1. Women \> age 18 with capacity to consent
2. Invasive breast cancer identified on CNB at AAMC within 45 days of study consent
3. IHC biomarkers performed on original CNB (including HER2)
4. Tumors with greater than 2cm of invasive disease (measured radiographically prior to resection or microscopically after resection), or
5. Multifocal or multicentric tumors

Exclusion Criteria:

1. Men
2. Women with HER2 positive tumors detected on CNB specimens
3. Women receiving neoadjuvant chemotherapy
4. Women whose CNB or surgical resection was performed at a hospital other than AAMC. If the CNB prior to resection was repeated at AAMC and new tumor biomarkers were performed, then the patient is eligible for enrollment
5. Women whose IHC marker results were inconclusive on CNB or not performed -

Primary outcomes:
measure: Benefit of additional Her2 testing
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Annapolis
country: United States
facility: Anne Arundel Medical Center
state: Maryland
Study officials:
References:
Clinical trial NCT06993961: Ultrasound Measurement of Optic Nerve Sheath Diameter as Non-Invasive Detector of Raised Intracranial Pressure in Adult Traumatic and Non-Traumatic Neurocritical Patients in ICU
Official title: Ultrasound Measurement of Optic Nerve Sheath Diameter as Non-Invasive Detector of Raised Intracranial Pressure in Adult Traumatic and Non-Traumatic Neurocritical Patients in ICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultrasound
Optic Nerve Sheath Diameter
Non-Invasive
Intracranial Pressure
Neurocritical
Intensive Care Unit
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 50
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: This observational prospective trial involved 50 cases aged \>18 years old, both sexes, presenting with suspected high intracranial pressure (ICP). The study was conducted from August 2022 to July 2023 after approval from the Ethical Committee of Ain Shams University Hospitals, Cairo, Egypt.

Brief summary: This study aimed to assess the role of ultrasound as a non-invasive method (bedside) to measure the rise of intracranial pressure by measuring the optic nerve sheath diameter in traumatic and nontraumatic neurocritical patients.

Detailed description: Measurement of intracranial pressure (ICP) is crucial in the management of many neurological conditions. However, due to the invasiveness, high cost, and required expertise of available ICP monitoring techniques, many patients who could benefit from it do not receive it. As a result, a substantial effort has been made to explore and develop novel non-invasive ICP monitoring techniques to improve the overall clinical care of patients suffering from ICP disorders.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years old.
* Both sexes.
* Patients with suspected high intracranial pressure.

Exclusion Criteria:

* Cases suffering from eye disease or optic nerve problems (Glaucoma, optic Nerve Tumor, Neuritis, Orbital Fracture).
* Patients suffering from mental illness render them incapable of communication \& cooperation (For Example: Dementia and irritability).
* Any previous intensive care surgeries \& hyperthyroidism (due to exophthalmos)

Primary outcomes:
measure: Intracranial Pressure
timeFrame: 24 hours post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT02234661: Expanding the Cycle of Opportunity: Simultaneously Educating Parents and Children in Head Start
Official title: Expanding the Cycle of Opportunity: Simultaneously Educating Parents and Children in Head Start
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children
Parents
Keywords: Low income
Education
Poverty
Children
Parents
Head Start
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2014-09-09
Enrollment: 311
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The CAP Family Advancement Study (CAP FAST) is a randomized control trial of CareerAdvance®, a dual-generation program providing education, career coaching, and soft-skills training for parents while their children attend CAP Tulsa's Head Start programs.

Detailed description: Randomization will take place with all applicants who have agreed to the study and are selected to participate in CareerAdvance®. Two-thirds of participants will be selected for the treatment group and will be able to enroll in CareerAdvance® immediately. The other one-third of the participants will be assigned to the control group and will not be able to enroll in CareerAdvance® for two years. Those who are selected for the control group will have access to CAP Tulsa's rich array of service outside of CareerAdvance®, including high quality early childhood education. The randomization process is introduced to parents during CareerAdvance® information sessions, and consent for the randomization process is required in order to apply to CareerAdvance®.

Eligibility criteria: Inclusion Criteria:

* Families whose children attend CAP Tulsa's Early Head Start and Head Start programs, and whose parents have applied to CareerAdvance®.

Exclusion Criteria:

* Participants who have not applied to CareerAdvance®..

Primary outcomes:
measure: Parent's educational achievement
timeFrame: 16 months
Secondary outcomes:
Other outcomes:
Locations:
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Tulsa
country: United States
facility: Oklahoma State University
state: Oklahoma
city: Tulsa
country: United States
facility: Community Action Project of Tulsa County
state: Oklahoma
Study officials:
affiliation: Northwestern University
name: P. Lindsay Chase-Lansdale, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03914261: Expanded Access to Risankizumab
Official title: Expanded Access to Risankizumab
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Crohn's Disease
Ulcerative Colitis (UC)
Keywords: Expanded Access
Pre-approval Access
Compassionate Use
Special Access Program
Named Patient Basis
Special Access Scheme
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-04-16
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This is an expanded access program (EAP) for eligible participants with Crohn's Disease (CD). This program is designed to provide access to risankizumab, prior to approval by the local regulatory agency, to patients with the highest unmet need and an urgent need for treatment, where risankizumab may prolong survival, prevent occurrence of clinical events associated with significant morbidity and/or mortality, or stabilize a progressive debilitating disease. Availability will depend on a review of the eligibility of the patient and local approval status of risankizumab for CD. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.



Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04153461: Mini- Percutaneous Nephrolithotomy Versus Standard Percutaneous Nephrolithotomy in the Treatment of Renal Stones.
Official title: Mini- Percutaneous Nephrolithotomy Versus Standard Percutaneous Nephrolithotomy in the Treatment of Renal Stones. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urolithiasis
Stone;Renal
Nephrolithiasis
PNL
PCNL
NEPHROLITHOTOMY
MINIPERC
Keywords: urolithiasis
stone, renal
nephrolithiasis
PNL
PCNL
NEPHROLITHOTOMY
MINIPERC
MINI-PERC
BLOOD LOSS
NEPHROSTOMY SIZE
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 210
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 EUA Urolithiasis Guidelines Panel meta-analysis suggest that mPNL is at least as efficacious and safe as sPNL for the removal of renal calculi. However, the quality of the evidence was poor, drawn mainly from small studies, the majority of which were single-arm case series, and only one of which was RCT. The risks of bias and confounding were high, highlighting the need for more reliable data from RCTs. So, the Panel recommended for more clinical research .

The aim of this study is to compare between PNL and mPNL through a randomized controlled trial.


Eligibility criteria: Inclusion Criteria:

1. Patient 18 years or older.
2. ASA I or II
3. Renal stones ≥ 2 cm
4. Lower calyceal stone ≥ 1 cm
5. Failure of other modalities of treatment as ESWL and RIRS.

Exclusion Criteria:

1. S.creatinine \> 2mg/dl.
2. Patients with active UTI.
3. Patients on anticoagulant.
4. Age \<18 years.
5. Ureteral obstruction preventing the insertion of a ureteral stent.

Primary outcomes:
measure: Assessment of stone free rate (SFR)
timeFrame: 2 years
Secondary outcomes:
measure: assessment of haemoglobin loss
timeFrame: 2 years
measure: assessment of pain
timeFrame: 2 years
measure: assessment of renal function
timeFrame: 2 years
measure: assessment of patient satisfaction
timeFrame: 2 years
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and Nephrology Center
state: Aldakahlia
Study officials:
References:
Clinical trial NCT01340261: Pediatric Pain Rehabilitation Program
Official title: Registry: Pediatric Pain Rehabilitation Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Chronic Pain
Keywords: Pediatric
Chronic Pain
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2011-04-22
Enrollment: 975
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants admitted to the Cleveland Clinic Children's Hospital's Pain Rehabilitation Program are eligible for enrollment in the registry.

Brief summary: The purpose of this study is to describe the demographic, medical, and psychological/behavioral characteristics of children and adolescent patients admitted to the Cleveland Clinic Children's Hospital's Pain Rehabilitation Program. The data will also be used to evaluate the clinical outcomes of patients admitted to the program as well as to examine the impact of various background factors on clinical outcomes.


Eligibility criteria: Inclusion Criteria:

* Admitted into the Cleveland Clinic Children's Hospital's Pain Rehabilitation Program

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Children's Hospital for Rehabilitation
state: Ohio
Study officials:
affiliation: Cleveland Clinic Children's Hospital
name: Gerard A Banez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01996761: Effects of Cerebrolysin on Motor Recovery in Patients With Subacute Stroke
Official title: Effects of Cerebrolysin on Motor Recovery in Patients With Subacute Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cerebrolysin
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2013-11-27
Enrollment: 71
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: This study, E-COMPASS is a phase IV clinical trial designed as a multicenter, randomized, double-blind, placebo-controlled, parallel-group study. This study will enroll 75 subacute stroke patients with unilateral motor dysfunction. Primary objective is to demonstrate the efficacy of porcine brain peptide to improve motor recovery measured by the improvement ratio of Fugl-Meyer assessment ((score of FMA after 3 weeks - score of FMA at baseline) / score of FMA at baseline) in patients with subacute stroke.


Eligibility criteria: Inclusion Criteria:

1. 1st cortical or subcortical unilateral infarction (supratentorial lesion)
2. Confirmed by CT or MRI
3. Subacute stage: less than 1 week
4. Moderate to severe motor function involvement-total of FMA: 0-84
5. Age: between 18 and 80 years
6. Inpatients

Exclusion Criteria:

1. Progressive or unstable stroke
2. Pre-existing and active major neurological disease
3. Pre-existing and active (e.g., on chronic medication) major psychiatric disease, such as major depression, schizophrenia, bipolar disease, or dementia
4. A history of significant alcohol or drug abuse in the prior 3 years
5. Advanced liver, kidney, cardiac, or pulmonary disease
6. A terminal medical diagnosis consistent with survival \< 1 year
7. Substantial decrease in alertness at the time of randomization, defined as score of 2 on NIH Stroke Scale
8. Pregnancy or lactating; note that a negative pregnancy test will be required if the patient is a female in reproductive years
9. Any condition that would represent a contraindication to Cerebrolysin, including allergy to Cerebrolysin
10. Current enrolment in another therapeutic study of stroke or stroke recovery
11. Total serum bilirubin \> 4 mg/dL, alkaline phosphatase \> 250 U/L, SGOT/AST \> 150 U/L, SGPT/ALT \> 150 U/L, or creatinine \> 3.5 mg/dL; or cardiopulmonary deficits large enough to interfere with reasonable participation in physiotherapy during the trial.
12. Previous porcine brain peptide administration history

Primary outcomes:
measure: the improvement ratio of Fugl-Meyer assessment
timeFrame: after 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
citation: Chang WH, Park CH, Kim DY, Shin YI, Ko MH, Lee A, Jang SY, Kim YH. Cerebrolysin combined with rehabilitation promotes motor recovery in patients with severe motor impairment after stroke. BMC Neurol. 2016 Mar 2;16:31. doi: 10.1186/s12883-016-0553-z.
Clinical trial NCT00610961: Induction Related BK Viremia in Renal Transplant Patients
Official title: The Induction Agent Effect on BK Viremia in Renal and Pancreas Transplant Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disease Due to BK Polyomavirus
Transplantation Infection
Disorder Related to Transplantation
Keywords: BK Polyomavirus
Transplantation, Kidney
Transplantation, Pancreas
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2008-02-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: de novo renal or renal/pancrease transplant patients

Brief summary: The increase immunosuppression in our transplant population has led to an unacceptable rate of patients at risk for BK virus nephropathy. Reducing induction immunosuppression by switching from Thymoglobulin to Simulect will reduce the incidence of serum positivity for BK by PCR.

Detailed description: Our standard of care has been changed from Thymoglobulin to Simulect and now patients were enrolled in this observational trial to gather data on their outcomes related to BK viremia and rejection rates. Two groups of patients were compared.

Retrospective (historical or control) group of subjects: patients who had received a kidney transplant and were inducted with Thymoglobulin prior to study initiation.

Prospective group of subjects: patients who is scheduled to receive kidney transplant and will be inducted with Simulect (Basiliximab).

Inductions in both groups was/is Standard of Care at a time of treatment.

Eligibility criteria: Inclusion Criteria:

* De novo transplant
* Aged 18-75

Exclusion Criteria:

* Serious medical condition which, in the opinion of the Principal Investigator, might interfere with the subject's ability to successfully complete the protocol.
* Any medical condition which, in the opinion of the Principal Investigator, might compromise the safety of the subject in participating in the protocol

Primary outcomes:
measure: BK Virus Viremia titer, >400 copies by Polymerase Chain Reaction (PCR)
timeFrame: One year
Secondary outcomes:
measure: Incidence of Acute Rejection of Transplanted Kidney
timeFrame: One year
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Herwig-Ulf Meier-Kriesche, MD
role: PRINCIPAL_INVESTIGATOR
References: