louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03138759: Effect of Probenecid on Pexidartinib Pharmacokinetics
Official title: An Open-label, Randomized, 2-treatment, 2-period, Crossover Study to Evaluate the Effect of Probenecid on the Pharmacokinetics of Pexidartinib in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics in Healthy Volunteers
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2017-05-03
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is an open-label, 2-treatment sequence, 2-period, crossover study with a washout between doses and treatment periods
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective of this trial is to assess the effect of probenecid on the pharmacokinetics (PK) of single-dose pexidartinib in healthy subjects.

Secondary objectives are to assess the safety and tolerability of pexidartinib alone and in combination with probenecid.

Participants will be confined to the clinic for approximately 32 days. Blood samples will be collected for PK analysis of pexidartinib and metabolites at predose and up to 312 hours (h) post dose.


Eligibility criteria: Inclusion Criteria:

* Is a healthy, nonsmoking person with a body mass index of 18 kg/m2 to 30 kg/m2 (inclusive) at Screening
* Is willing to be confined at the clinic for approximately 32 days
* Is surgically sterile or a naturally postmenopausal female and not lactating, or a male who agrees to use double barrier methods of contraception and avoid donating sperm from Check-in until 90 d after the final dose of pexidartinib

Exclusion Criteria:

* Has any history or condition, per protocol or in the opinion of the investigator, that might compromise the participant's safety, their ability to complete the trial, and or analysis of results

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax)
timeFrame: predose to 312 hours post dose
measure: Time to Maximum Concentration (Tmax)
timeFrame: within 312 hours post dose
measure: Area under the curve to the last quantifiable measurement (AUClast)
timeFrame: within 312 hours post dose
Secondary outcomes:
measure: Number of participants experiencing an adverse event
timeFrame: within 312 hours post dose
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Worldwide Clinical Trials Early Phase Services
state: Texas
Study officials:
affiliation: Daiichi Sankyo
name: Clinical Study Leader
role: STUDY_DIRECTOR
References:
citation: Zahir H, Greenberg J, Shuster D, Hsu C, Watanabe K, LaCreta F. Evaluation of Absorption and Metabolism-Based DDI Potential of Pexidartinib in Healthy Subjects. Clin Pharmacokinet. 2022 Nov;61(11):1623-1639. doi: 10.1007/s40262-022-01172-9. Epub 2022 Oct 20.
Clinical trial NCT00654459: Effects of Armolipid Plus on Cholesterol Levels and Endothelial Function
Official title: Effects of Armolipid Plus on Cholesterol Levels and Endothelial Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperlipidemia
Endothelial Dysfunction
Lead sponsor: Federico II University
Sponsor class: OTHER
Collaborators: name: Rottapharm
First posted: 2008-04-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: males and females aged between 18 and 70 with hypercholesterolemya

Brief summary: Some nutraceuticals are often advised for their lipid lowering effects. Although many clinical trials have been conducted to assess their efficacy many doubts remain whether they could be considered an effective alternative to statins therapy.

The aim of this study was to evaluate the lipid lowering effects and the improvement of endothelial dysfunction in patients with hyperlipidemia, treated with a nutraceutical product (Armolipid Plus)


Eligibility criteria: Inclusion Criteria:

* Males and females aged between 18 and 70
* Total cholesterol levels \> 220 mg/dl and LDL-Cholesterol \> 130 mg/dl;
* Patients with concomitant pathology such as diabetes, chronic heart failure, coronary artery disease, arterial hypertension, dysthyroidism, were admitted as long as stable in the previous three months

Exclusion Criteria:

* Proven intolerance to an Armolipid Plus compound
* Pregnant women, and women planning to conceive
* Patients in therapy with lipid lowering drugs within the previous 6 weeks
* Triglycerides concentration \> 500mg/dl were excluded.

Primary outcomes:
measure: The primary outcome measure of this study was the percentage change from baseline of total cholesterol (C), LDL- cholesterol (LDL-C), HDL-cholesterol (HDL-C),and Triglycerides (Tg) plasma concentrations.
timeFrame: 6 weeks
Secondary outcomes:
measure: Secondary end point included improvement of endothelial dysfunction assessed by an echo flow mediated distribution test.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Department of internal medicine University Federico II
Study officials:
affiliation: Federico II University
name: Serafino Fazio, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01411475: Prognostic Assessment of Different Pattern of Bifurcation Restenosis
Official title: Classification of Bifurcation Restenosis: a Prognostic Assessment
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: In-stent Coronary Artery Restenosis
Lead sponsor: Ospedale Santa Maria Goretti
Sponsor class: OTHER
First posted: 2011-08-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Coronary artery disease

Brief summary: The LATINA registry aims at assessing a new classification of bifurcation restenosis in the prediction of major adverse cardiac events in patients who have previously undergone a succesful percutaneous bifurcation intervention.


Eligibility criteria: Inclusion Criteria:

* age \>18 years
* restenosis involving a coronary bifurcation previously treated percutaneously

Exclusion Criteria:

* life expectancy \>1 year

Primary outcomes:
measure: Major adverse cardiac events
timeFrame: 12 months
Secondary outcomes:
measure: Cardiac death
timeFrame: 12
measure: Non-fatal myocardial infarction
timeFrame: 12 months
measure: Target vessel revascularization
timeFrame: 12 month
Other outcomes:
Locations:
city: Latina
country: Italy
facility: S.M. Goretti
city: Latina
country: Italy
facility: S.M. Goretti
Study officials:
References:
citation: Sgueglia GA, Todaro D, Stipo A, Pucci E. Simultaneous inflation of two drug-eluting balloons for the treatment of coronary bifurcation restenosis: a concept series. J Invasive Cardiol. 2011 Nov;23(11):474-6.
Clinical trial NCT00722059: Detection and/or Evaluation of Dense Breast Abnormalities Using Tomosynthesis and Digital Mammography
Official title: Assessment of Emerging Technology: Comparison of Breast Tomosynthesis and Digital Mammography in the Evaluation of Heterogeneously Dense and Extremely Dense Breasts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Breast Neoplasms
Breast Abnormalities
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2008-07-25
Enrollment: 50
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to compare 3D mammography with digital mammography in women with dense breasts for the detection and evaluation of masses and/or breast cancer.


Eligibility criteria: Inclusion Criteria:

* Females 30 years of age or older.
* Dense Breasts.
* Has undergone clinical two view mammogram and diagnostic breast imaging evaluation.
* Suspicious or palpable mass and scheduled for biopsy.

Exclusion Criteria:

* Pregnant or lactating women.
* Prior personal history of breast cancer.
* Prior breast augmentation with implants or silicon injection. male patients.
* No two view mammogram as part of breast imaging evaluation.
* Breast density of almost entirely fatty/scattered fibroglandular densities.

Primary outcomes:
measure: Measure of digital tomosynthesis and digital mammography test performance.
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
Study officials:
affiliation: University of Michigan
name: Alexis V. Nees, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04369859: Obstetric and Perinatal Outcomes of Women With COVID-19
Official title: Obstetric and Perinatal Outcomes of Women With COVID-19: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnant Women
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 556
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cases will be recruited among all pregnant women aged \>18 years old who have tested positive for COVID-19 and are followed in a maternity belonging to the French South regional perinatology network

Brief summary: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is currently spreading rapidly around the globe, causing a major public health issue. There is currently very few data about the impact of COVID-19 on pregnancy, and potential in utero infection. This is a prospective observational study of COVID-19 diagnosed pregnant patients. This objective is to examine the impact of COVID-19 during pregnancy on the rates of obstetric and perinatal complications.

Detailed description: Clinical manifestations of COVID-19 can range from a benign upper respiratory tract infection to severe acute respiratory distress syndrome (ARDS), fatal in 1% of cases. However, pregnant women and their fetuses could particularly be vulnerable to the infection, as shown by previous human coronavirus outbreaks (SARS-CoV and MERS-CoV).

Cases will be recruited among all pregnant women aged \>18 years old who have tested positive for COVID-19 and are followed in a maternity belonging to the French South Regional Perinatology Network. Voluntary physicians will refer eligible participants to the study-coordinating center at APHM University Hospital. The participants will be followed by phone after having provided an informed consent. Clinical symptoms, laboratory and imaging findings, maternal and perinatal outcomes will be recorded.

Eligibility criteria: Inclusion Criteria:

* Pregnant women
* Able to give informed consent
* Diagnosed with COVID-19

Exclusion Criteria:

* Patients Refusing to Participate in the Study
* Patients who do not speak French well enough to benefit from clear and intelligible information

Primary outcomes:
measure: Compare the complications rates
timeFrame: 12 months
Secondary outcomes:
measure: Clinical presentation
timeFrame: 12 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
state: Paca
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Jean-Olivier ARNAUD, Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06514859: Repair of Inguinal Hernia
Official title: Outcomes of Laparoscopic Versus Open Repair of Inguinal Hernia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inguinal Hernia
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 50
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 aim of this study is to compare the outcomes of open versus laparoscopic approaches for inguinal hernia surgery and provide evidence-based guidance to the selection of the most appropriate operative technique.


Eligibility criteria: Inclusion Criteria:

Male patient \> 18 years of age

• Primary groin hernias requiring surgical intervention that are eligible for both open and laparoscopic repair.

Exclusion Criteria:

* Emergency procedures .

  * ASA score \> 2.
  * Irreducible inguinoscrotal hernia .
  * Local or systemic infection .
  * Other abdominal hernias being operated at the same time or planned operated during Follow up.

Previous surgery which has impaired the sensation in the groin area .

* BMI \> 40 kg/m2.
* Known disease which Impairs central or peripheral nerve function .
* Concurrent malignant Disease .
* Chronic pain which requires daily medication . • Mental disorder which requires daily medication .

Primary outcomes:
measure: Recurrence in management of inguinal hernia
timeFrame: 6 months after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Bhandarkar DS, Shankar M, Udwadia TE. Laparoscopic surgery for inguinal hernia: Current status and controversies. J Minim Access Surg. 2006 Sep;2(3):178-86. doi: 10.4103/0972-9941.27735.
citation: Aguirre DA, Casola G, Sirlin C. Abdominal wall hernias: MDCT findings. AJR Am J Roentgenol. 2004 Sep;183(3):681-90. doi: 10.2214/ajr.183.3.1830681. No abstract available.
citation: McCormack K, Wake B, Perez J, Fraser C, Cook J, McIntosh E, Vale L, Grant A. Laparoscopic surgery for inguinal hernia repair: systematic review of effectiveness and economic evaluation. Health Technol Assess. 2005 Apr;9(14):1-203, iii-iv. doi: 10.3310/hta9140.
Clinical trial NCT00382759: Nonmyeloablative Stem Cell Transplant in Elderly
Official title: Nonmyeloablative Allogeneic Stem Cell Transplantation in Elderly Patients With Hematological Malignancies:Results From the GITMO (Gruppo Italiano Trapianto Midollo Osseo)Multicenter Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hematological Malignancies
Lead sponsor: Azienda Ospedaliera San Giovanni Battista
Sponsor class: OTHER
First posted: 2006-10-02
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study aimed to evaluate the efficacy of a nonmyeloablative conditioning consisting of fludarabine and total body irradiation in patients older than 60 years of age

Detailed description: A total of 35 patients with hematological malignancies were treated with fludarabine (30 mg/m2 x 3-5 days) and 200 cCy TBI followed by allogeneic hematopoietic stem cell transplantation (HSCT) from a matched-sibling donor.

Neutrophil recovery occurred in 89% of the patients at a median time of 15 days. On day +30, 10 patients had \> 95% donor chimerism, and 21 patients had mixed chimerism. The cumulative probabilities of grade II-IV acute GVHD and chronic GVHD were 51% and 84% respectively. Transplant-related mortality at 100 days and 1 year was 5% and 9% respectively. The probabilities of 1-year overall (OS) and progression-free survival (PFS) were 55% and 47% respectively. The estimated 1-year probability of OS and PFS for patients in early disease stages were 87% and 74% respectively , which were significantly higher than the survival and PFS estimates of 12% obtained in patients with advanced disease stages at the time of transplant

Eligibility criteria: Inclusion Criteria:

* patients with myeloid or lymphoid malignancy who were \> 60 years old potentially treatable with stem cell transplant

Exclusion Criteria:

* lack of an HLA-identical sibling donor

Primary outcomes:
measure: overall survival
measure: progression-free survival
measure: transplant-related mortality
Secondary outcomes:
measure: acute GVHD
measure: chronic GVHD
Other outcomes:
Locations:
city: Torino
country: Italy
facility: Ospedale San Giovanni Battista
Study officials:
affiliation: ospedale san giovanni battista
name: michele falda, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00007059: Study of the Pharmacokinetics of Mycophenolate Mofetil in Patients Who Have Undergone Orthotopic Liver Transplantation
Official title: Study of the Pharmacokinetics of Mycophenolate Mofetil in Patients Who Have Undergone Orthotopic Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Graft Versus Host Disease
Keywords: disease-related problem/condition
graft versus host disease
rare disease
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: University of North Carolina
First posted: 2000-12-07
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Determine the effects of bile externalization and antibiotic gut sterilization on the pharmacokinetics of mycophenolate mofetil in patients who have undergone orthotopic liver transplantation.

II. Correlate serum concentrations of mycophenolic acid with inosine monophosphate dehydrogenase activity in these patients.

Detailed description: PROTOCOL OUTLINE:

Patients begin a mycophenolate mofetil (MMF)-containing regimen within the first 5 days after transplantation. Patients have blood drawn on postoperative days 7, 21, 42, 70, 98, 126, and 154. Urine is collected on postoperative days 7, 21, and 42. Patients with T-tube bile externalization also have bile collected on postoperative day 7.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Orthotopic liver or kidney transplant recipients who started on a mycophenolate mofetil-containing immunosuppressive regimen within 5 days after transplant

Kidney transplant recipients will serve as study controls

--Prior/Concurrent Therapy--

* No concurrent bile acid sequestrants
* No mycophenolate mofetil as part of rescue therapy regimen
* No concurrent albumin replacement therapy

--Patient Characteristics--

Renal: Urine output at least 500 mL/day OR Creatinine less than 2.5 mg/dL

Other:

* Not pregnant
* No mental incompetency
* No prisoners or parolees HIV negative
* No active infection defined as: Temperature above 101 F with WBC greater than 12,000/mm3 and left shift OR Two or more positive cultures of a single isolated organism from blood, urine, or sputum

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina School of Medicine
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Robert E. Dupuis
role: STUDY_CHAIR
References:
Clinical trial NCT01053559: Assessment of Small Bowel Healing in Crohn's Disease Patients Treated With Cimzia Using Wireless Capsule Endoscopy
Official title: Open Label Investigator Initiated, Single Site Study of Mucosal Healing in Patients With Small Bowel Crohn's Disease Treated With Certolizumab Pegol (Cimzia) Assessed by Wireless Capsule Endoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn's Disease
Keywords: Crohn's
Inflammatory Bowel Disease
Lead sponsor: Shafran Gastroenterology Center
Sponsor class: OTHER
Collaborators: name: UCB Pharma
First posted: 2010-01-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Wireless Capsule Endoscopy has been the most reliable diagnostic standard for small bowel Crohn's disease. Endoscopic healing is an important endpoint to measure response to treatment.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18-70 with confirmed Crohn's disease that includes small bowel disease
* Moderately to severely active disease (CDAI score \>220 and \< 450)
* Stable doses of steroids, 5-ASA, antibiotics, Immunosuppressants

Exclusion Criteria:

* Any and all contraindications to the use of certolizumab pegol (including but not limited to hepatitis, infection, abscess, malignancy, congestive heart failure \[CHF\], cytopenia)
* Small bowel obstruction, stricture, or any contraindication for capsule endoscopy
* Previous treatment with certolizumab pegol
* Are pregnant or lactating

Primary outcomes:
measure: Mucosal Healing
timeFrame: 180 Days
Secondary outcomes:
measure: C-Reactive Protein (CRP) Level
timeFrame: 180 Days
Other outcomes:
Locations:
city: Winter Park
country: United States
facility: Shafran Gastroenterology Center
state: Florida
Study officials:
affiliation: Shafran Gastroenterology Center
name: Ira Shafran, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06074159: Impacts of Clinician-Mediated Report-Back
Official title: Expanding Effective Report-back of Environmental Exposures in Clinic-Based Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Knowledge, Attitudes, Practice
Lead sponsor: Silent Spring Institute
Sponsor class: OTHER
Collaborators: name: University of Puerto Rico
name: Northeastern University
name: Harvard University
First posted: 2023-10-10
Enrollment: 162
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All study participants in two pregnancy cohorts will get a personal exposure report for chemicals measured during their pregnancy. 200 participants from each cohort (N Total= 400) are randomly selected and assigned equally to one of two groups: 1) those who only receive their personal results online and 2)those who receive in-clinic to measure differences in participants' environmental health literacy. Pre-and post-tests are administered before and after report-back.
Primary purpose: OTHER

Brief summary: The study trains clinicians to return personal exposure results to study participants in pregnancy cohorts, and measures outcomes for environmental health literacy for both clinicians and study participants.

Detailed description: To design and implement clinic-based report-back for endocrine disrupting compounds and analyze the impacts of doing so, investigators train clinicians to report-back individual chemical results to study participants in two pregnancy cohorts and then evaluate outcomes for both clinicians and patients, including shifts in environmental health behaviors, using interviews and pre-and post-tests. All study participants will get a personal exposure report and 200 participants from each cohort (N Total= 400) are randomly selected and assigned equally to one of two groups: 1) those who only receive their personal results online and 2)those who receive them in-clinic to measure additional benefits of clinical report-back for participant learning, exposure-related behaviors, and relationships to the study and clinical care.

Eligibility criteria: Inclusion Criteria:

* Participants are of reproductive age

Exclusion Criteria:

* Under 18 years old or past reproductive age

Primary outcomes:
measure: Environmental health literacy as measured by pre-and post-tests (questionnaires).
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard T.H Chan School of Public Health
state: Massachusetts
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico Medical Sciences Campus
Study officials:
affiliation: Silent Spring Institute
name: Jennifer Ohayon, PhD
role: PRINCIPAL_INVESTIGATOR
References: