louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00322114: Lycopene in Preventing Prostate Cancer in Healthy Participants
Official title: Mechanism of Prostate Cancer Prevention by Lycopene
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-05-04
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: PREVENTION

Brief summary: RATIONALE: Chemoprevention is the use of certain drugs or substances to keep cancer from forming, growing, or coming back. The use of lycopene, a substance found in tomatoes, may keep prostate cancer from forming.

PURPOSE: This randomized clinical trial is studying how well lycopene works in preventing prostate cancer in healthy participants.

Detailed description: OBJECTIVES:

Primary

* Determine whether lycopene supplementation affects percent free and bound prostate-specific antigen (PSA) in healthy participants.

Secondary

* Determine whether lycopene reduces oxidative stress in these participants, as indicated by lipid peroxidation assay.
* Determine whether a 21-day washout period is sufficient to return lycopene, PSA, and lipid peroxidation products to baseline.

OUTLINE: This is a randomized, placebo-controlled study. Participants are randomized to 1 of 3 treatment arms.

* Arm I: Participants receive an oral tomato dietary supplement containing lycopene twice daily for 3 weeks.
* Arm II: Participants receive an oral tomato dietary supplement containing lycopene at a higher dose twice daily for 3 weeks.
* Arm III: Participants receive oral placebo twice daily for 3 weeks. Urine and blood samples are collected on days 0, 21, and 42.

PROJECTED ACCRUAL: A total of 150 participants will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Healthy participants
* No existing prostate disease

PATIENT CHARACTERISTICS:

* Able to supply blood and urine samples
* Able to answer demographic and dietary recall questionnaires
* No hospital inpatients
* Not allergic to tomatoes or tomato products
* Not abusing alcohol or non-prescribed drugs
* No existing gastrointestinal disease or cancer

PRIOR CONCURRENT THERAPY:

* At least 2 weeks since prior lycopene (in supplement form)
* No concurrent participation in another clinical trial

Primary outcomes:
measure: Measurement of changes in percent free and total serum prostate-specific antigen (PSA) induced by lycopene
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois Cancer Center
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Richard B. van Breemen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04961814: Preoperative Pediatric Fasting Regimens
Official title: Gastric Ultrasound Assessment of Two Preoperative Fasting Regimens in Pediatric Patients: a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 200
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The presence of gastric contents makes an aspiration event more likely , and as a result, preoperative fasting guidelines are designed to provide adequate time for gastric emptying in patients undergoing surgery. this study will be conducted to assess the gastric volume and content with the help of ultrasound in fasted pediatric patients scheduled for elective surgeries

Detailed description: it is unknown how many patients have gastric volumes that place them at increased risk of aspiration despite adequate fasting.

There is a growing interest in the use of bedside ultrasonography to assess gastric content and volume. It has been suggested that the gastric antrum in particular can be assessed reliably by sonography.

hence, this study will be conducted to assess the gastric volume and content with the help of ultrasound in fasted pediatric patients scheduled for elective surgeries which will help to detect accuracy of preoperative fasting hours.

Eligibility criteria: Inclusion Criteria:

* paediatric patients aged 6-12 years old
* ASA physical status I and II
* scheduled for elective surgeries
* the anticipated duration of 30-60 min

Exclusion Criteria:

* parents' refusal
* overweight or obesity
* expected difficult airway management
* increased abdominal pressure
* diabetes mellitus
* congenital diseases
* GERD or esophageal disease
* uncooperative patients,
* mental retardation or neurological disease
* upper airway surgeries.

Primary outcomes:
measure: proportion of patients with a risky stomach.
timeFrame: immediately preoperative
Secondary outcomes:
measure: gastric content quality
timeFrame: immediately preoperative
measure: fasting hours
timeFrame: the new preoperative fasting (6 hours for solids, 4 hours for milk, non-clear fluid or light breakfast, and 0 hours for clear fluids)
measure: type of last meal
timeFrame: last meal within 24 hours preoperative
measure: episodes of gastric regurgitation, vomiting , aspiration
timeFrame: during induction or emergence from anesthesia (within 30 minutes)
measure: gastric volume
timeFrame: immediately preoperative (within 30 minutes)
measure: parents satisfaction
timeFrame: after PACU discharge (within 2 hours postoperative)
measure: cancellation
timeFrame: decision will be taken within 30 minutes preoperative
measure: adverse events
timeFrame: preoperative or postoperative
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University, Faculty of Medicine
Study officials:
affiliation: Tanta University, Faculty of Medicine
name: Mona R Elghamry, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04119414: Like Father Like Son
Official title: Increasing Early Infant Male Circumcision Uptake in Zambia: Like Father Like Son
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Knowledge, Attitudes, Practice
Health Risk Behaviors
Keywords: Early Infant Male Circumcision
HIV infection
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-10-08
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This purpose of this study is to look at the best way to offer the Like Father Like Son + Spear \& Shield program.


Eligibility criteria: Inclusion Criteria:

* Men and women must be able to understand and sign the Informed Consent in English or local language.
* All participants must be adults able to provide consent
* Women participants may be pregnant
* Individuals not yet adults (infants, children, teenagers) are not eligible to participate
* Prisoners will not be eligible for recruitment

Exclusion Criteria:

- Participants not meeting any of the inclusion criteria.

Primary outcomes:
measure: Number of Early Infant Male Circumcision
timeFrame: Up to 60 days of life
measure: Number of Voluntary Medical Male Circumcision
timeFrame: Up to 12 months
measure: Number of Parents' Who Indicate They Plan to Circumcise Their Infants
timeFrame: Up to 12 months
measure: Clinic Level (Cluster) Number of Early Infant Male Circumcision (EIMC)
timeFrame: 30 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: Lusaka Province Community Health Clinics
Study officials:
affiliation: University of Miami
name: Stephen Weiss, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03925714: Impact of P53 and SIRT1 in Type 2 Diabetes
Official title: Investigating the Impact of p53 and SIRT1 in the Development of Type 2 DM Through the Treatment of Prediabetic Individuals by Either Nigetella Salivata or Metformin
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: DM
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2019-04-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Investigating the impact of p53 and SIRT1 in the development of type 2 DM

Detailed description: Investigating the impact of p53 and SIRT1 in the development of type 2 DM through the treatment of prediabetic individuals by either nigetella salivata or Metformin

Eligibility criteria: Inclusion Criteria:

* Prediabetic subjects.

Exclusion Criteria:

* Confirmed diabetes.
* Hepatic or renal impairment.

Primary outcomes:
measure: Number of patients with improved insulin resistance
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Sherief Abd-Elsalam
Study officials:
affiliation: Tanta University - Faculty of Pharmacy
name: Eman SA Sawan, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Tanta University - Faculty of Pharmacy
name: Sahar Hegazy, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Tanta University - Faculty of Pharmacy
name: Tarek Mostafa, ass. Prof.
role: STUDY_DIRECTOR
affiliation: Tanta University-Faculty of pharmacy
name: Sherin El-Nidany, MD
role: STUDY_CHAIR
References:
citation: Mostafa TM, Hegazy SK, Elnaidany SS, Shehabeldin WA, Sawan ES. Nigella sativa as a promising intervention for metabolic and inflammatory disorders in obese prediabetic subjects: A comparative study of Nigella sativa versus both lifestyle modification and metformin. J Diabetes Complications. 2021 Jul;35(7):107947. doi: 10.1016/j.jdiacomp.2021.107947. Epub 2021 May 8.
Clinical trial NCT03560414: The Plasma Diafiltration Therapy of Hepatic Failure
Official title: Study of High - Flux Plasma Diafiltration Based on Plasma - Saved Mode in the Treatment of Patients With Hepatic Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatic Failure
Plasma Exchange
Lead sponsor: Fuzhou General Hospital
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: At present, there is no comparative study between the simple plasma exchange and plasma diafiltration (PDF), and no further exploration of optimal plasma dose in PDF treatment. Therefore, this prospective randomized cohort study aims to compare the safety and effectiveness of the tree groups（simple plasma exchange group, conventional PDF treatment group, less plasma PDF treatment group）by collecting SOFA score, 3-month survival rate, MELD score, and the times of artificial liver treatment , blood cell variables, cytokines(e.g. TNFα ), pre- and post-treatment plasma ammonia levels. Thus, it is to provide a safer and more effective artificial liver treatment with less plasma dose.


Eligibility criteria: Inclusion Criteria:

* hepatic failure on Medium period
* Model for End-Stage Liver Disease (MELD) \<30 and \>20
* age \> 18 years and \<70years
* Written informed consent

Exclusion Criteria:

* Active bleeding or disseminated intravascular coagulation
* allergic to blood products or drugs such as plasma, heparin and protamine
* hemodynamic instability
* cardiovascular and cerebrovascular accidental infarction instability Period
* extravascular hemolysis
* severe sepsis
* Tumor on ultrasonography, CT or MRI examination
* Pregnant or lactating women

Primary outcomes:
measure: Model for end-stage liver disease （MELD score）
timeFrame: month 3
Secondary outcomes:
measure: cytokine
timeFrame: Month 3
measure: blood platelet count
timeFrame: Month 3
measure: the number of artificial liver treatment
timeFrame: Month3
measure: the concentration of plasma ammonia
timeFrame: Month 3
measure: sequential organ failure assessment score（SOFA score）
timeFrame: Month 3
measure: survival rate
timeFrame: Month 3
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fuzhou General Hospital, Xiamen Univ
state: Fujian
Study officials:
References:
Clinical trial NCT00186914: Stromal Therapy of Osteodysplasia After Allogeneic Bone Marrow Transplantation
Official title: Stromal Therapy of Osteodysplasia After Allogeneic Bone Marrow Transplantation: A Phase I Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteodysplasia
Keywords: Bone marrow transplant
bone marrow stromal cells
allogeneic transplant
Osteodysplasia
Osteogenesis imperfecta
Gene marking
Stromal cell
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
Collaborators: name: Drexel University
name: Wayne State University
First posted: 2005-09-16
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Osteodysplasia or poorly formed bones, "brittle bones" is a genetic disease with no known proven treatments. Some forms of osteodysplasia may cause severe disability and even death.

Eligible patients were limited to those children with Osteodysplasia who had undergone a previous allogeneic bone marrow transplant at St. Jude. The study intervention involved an infusion of a specified number of ex vivo expanded stromal cells obtained from the bone marrow of the same donor from whom they received their primary transplant procedure. These bone marrow stromal cells can become bone-forming cells, called osteoblasts. Participants then received 2 infusions of ex vivo expanded, gene marked cells not less than 6 months after bone marrow transplantation. The second cell infusion occurred between 14 to 21 days after the first infusion in the absence of toxicity. The goal of the study was to evaluate the safety and toxicity of these infusions.

Detailed description: * To determine whether these ex vivo expanded, gene marked marrow stromal cells will engraft in the recipient's bone, bone marrow, and/or skin.
* To begin to investigate whether high proliferative mesenchymal progenitor cells can be expanded ex vivo and retain their progenitor potential in vivo.
* To begin to investigate whether ex vivo expanded bone marrow stromal cells can ameliorate the skeletal dysplasias associated with various genetic disorders.

Eligibility criteria: Inclusion Criteria:

* Patients with an appropriate genetic disorder who have had an allogeneic bone marrow transplant and currently maintain complete or mixed hematopoietic chimerism
* Patient must be \< or equal to 18Kg

Exclusion Criteria:

* Presence of infection
* Presence of GVHD (graft versus host disease)or the need for prophylaxis
* Concurrent participation in any investigational study that could potentially confound the interpretation of the safety parameters being investigated in this study.

Primary outcomes:
measure: To evaluate the safety of the stromal cell infusion
timeFrame: June 2001
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Kimberly Kasow, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00284414: Is Ultrasonography Comparable to MRI for the Detection of Morton Neuroma of the Foot?
Official title: Is Ultrasonography Comparable to MRI for the Detection of Morton Neuroma of the Foot?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Morton Neuroma
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2006-01-31
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with Morton neuroma of the foot will undergo either ultrasonography or MRI. The results will be compared.

In case of surgery, the pathology report will be compared with the ultrasonographic or MRI findings.

Which is the most reliable and specific: ultrasonography or MRI?


Eligibility criteria: Inclusion Criteria:

* Morton neuroma of the foot

Exclusion Criteria:

-

Primary outcomes:
measure: Reliability and specificity of ultrasonography and MRI for detection of Morton neuroma of the foot
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Ghent
name: Rene Verdonk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01130714: Resistance Training in Lung Cancer Patients on Chemotherapy
Official title: Effectiveness of a Resistance Training Program on Inflammatory Markers and Chemotherapy Completion in Lung Cancer Patients on Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Lung Cancer
Keywords: inflammation
chemotherapy
lung cancer
Lead sponsor: East Carolina University
Sponsor class: OTHER
First posted: 2010-05-26
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to examine the effectiveness of a resistance training program on reducing systemic inflammation and improving chemotherapy completion in lung cancer patients being treated with curative intent chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Histologically diagnosed with lung cancer
* Stage I, II, or III
* Eligible for chemotherapy with curative intent
* 21 years of age or older
* Approval to participate in study by treating oncologist or family physician

Exclusion Criteria:

* Unstable cardiac disease
* Untreated bone or brain metastases

Primary outcomes:
measure: Systemic inflammation measured by c-reactive protein.
timeFrame: 12 weeks
Secondary outcomes:
measure: Chemotherapy completion
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Leo Jenkins Cancer Center
state: North Carolina
Study officials:
affiliation: East Carolina University
name: Kristina H Karvinen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karvinen KH, Esposito D, Raedeke TD, Vick J, Walker PR. Effect of an exercise training intervention with resistance bands on blood cell counts during chemotherapy for lung cancer: a pilot randomized controlled trial. Springerplus. 2014 Jan 8;3:15. doi: 10.1186/2193-1801-3-15. eCollection 2014.
Clinical trial NCT05098314: Impact of Personalized Interventions to Raise Teleconsultation Awareness in EHPAD
Official title: Impact of Personalized Interventions to Raise Teleconsultation Awareness: The Case of the Cicat-Occitanie Network and Healthcare Professionals in Lozère's EHPADs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wound Healing Disorder
Keywords: telemedicine
Cluster Randomised Trial
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 1612
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All residents of Lozère's EHPADs

Brief summary: The cicat-occitanie network offers expertise for health professionals concerning wound care, in particular through teleconsultations. This study aimed to understand the obstacles reported by healthcare professionals in Lozere's EHPAD related to the use of this network. This cluster randomized controlled trial also sought to evaluate the effect of personalized intervention for each EHPAD on the use of this network.


Eligibility criteria: Inclusion criteria:

- Be a resident in Lozère's EHPAD

Exclusion Criteria:

- Patient who reject the study protocol

Primary outcomes:
measure: Requests rate for teleconsultations
timeFrame: 3 months
Secondary outcomes:
measure: Human obstacles linked to the use of teleconsultations
timeFrame: 4 months
measure: Organizational obstacles linked to the use of teleconsultations
timeFrame: 4 months
measure: Economic obstacles linked to the use of teleconsultations
timeFrame: 4 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Bastien Paul
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00359814: Exchange of Azathioprine by Mycophenolatmofetile and Cyclosporine A Dose Reduction After Heart Transplantation
Official title: Conversion Study to Optimize Immunosuppressive Regimen by Exchange of Azathioprine by Mycophenolatmofetile and Cyclosporine A Dose Reduction for Patients After Heart Transplantation in Lon-Term
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Transplantation
Keywords: Cyclosporine
renal insufficiency, chronic
long-term care
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2006-08-02
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to improve or save renal function by optimizing the immunosuppressive regimen by reducing the Cyclosporine A dose and the exchange of Azathioprine by Mycophenolatmofetile, which is an effective immunosuppressive agent and will minimize the risk of acute rejection episodes.

Detailed description: The decrease of quality of life in patients after heart transplantation in the long-term is determined by an increasing incidence of transplant vasculopathy and by immunosuppression-related side effects.Long-term administration of calcineurin inhibitors is associated with chronic nephrotoxicity.

Eligibility criteria: Inclusion Criteria:

* Current immunosuppressive regimen: Cyclosporine A, Azathioprine and corticosteroids for at least 12 month
* Heart transplantation above 3 years dated back
* Serum creatinine \< 3,5 mg/dl (310 µmol/l) and BUN \< 150 mg/dl
* Cyclosporine A blood level between 50 and 250 ng/ml during the last 12 month

Exclusion Criteria:

* Carcinoma within the last 3 years
* Acute rejection episodes during the last 6 month
* Infection requiring therapeutic intervention
* Hepatitis B, Hepatitis C or HIV infection
* WBC \< 3000/µl, haemoglobin \< 9g/dl, platelets \< 70.000/µl
* Florid gastrointestinal ulcer
* Haemodialysis within the last 4 weeks before study entry
* Pregnancy / lactation
* Administration of other immunosuppressive agents than prescribed
* Mycophenolatmofetile incompatibility

Primary outcomes:
measure: Renal function evaluated by serum creatinine at month 12 and month 24
timeFrame: month 12 and month 24
Secondary outcomes:
measure: acute rejection episodes, gastrointestinal disorders and other adverse events at month 12 and month 24
timeFrame: month 12 and month 24
measure: Cardiovascular risk factors at month 12 and month 24
timeFrame: month 12 and month 24
measure: Quality of life assessed by the SF36, spiroergometry, concomitant medication at month 12 and month 24
timeFrame: month 12 and month 24
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School, Department of Thoracic and Cardiovascular Surgery
Study officials:
affiliation: Hannover Medical School, Department of Thoracic and Cardiovascular Surgery
name: Christoph Bara, Dr. med.
role: STUDY_DIRECTOR
References: