louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01748916: Comparison of Carotenoid Bioavailability From Fresh Papaya, Tomato and Carrot
Official title: Evaluation of the Effect of the Consumption of Papaya, Tomato, and Carrot on the Bioavailability of Carotenoids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Focus of Study: Carotenoid Absorption
Keywords: Papaya
Carrot
Tomato
Carotenoids
Lycopene
Beta-carotene
Beta-cryptoxanthin
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: University of Hohenheim
name: Universidad de Costa Rica
First posted: 2012-12-13
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this study is to determine if papaya fruits are an exceptionally good food source for carotenoids in humans, particularly when compared more common carotenoid sources like carrots and tomatoes. This objective will be accomplished by quantitation of the immediate post-prandial plasma concentrations of parent carotenoids and vitamin A metabolites from subjects who consumed a meal containing fresh papaya, tomato, and carrot.

Detailed description: The main purpose of this study is comparing bioavailability of papaya carotenoids versus carrot and tomato carotenoids. Previously, vitamin A deposition in rat livers was studied, showing that carotenoid bioavailability from papaya is higher than from spinach, parsley and carrots. Detailed knowledge about human carotenoid absorption and conversion from papaya fruit compared to other food sources is still lacking.

Eligibility criteria: Inclusion Criteria:

* healthy individuals

Exclusion Criteria:

* lactating, pregnant, or planned to be pregnant
* smokers/those who use tobacco products
* metabolic or malabsorption disorders
* had a history of cancer
* history of liver insufficiency or other gastro-intestinal diseases
* allergy to papaya, carrots or tomatoes
* obesity

Primary outcomes:
measure: Pharmacokinetics of Carotenoid Absorption From Papaya, Carrot and Tomato
timeFrame: 8 post-prandial blood samples over 9.5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: San José
country: Costa Rica
facility: University of Costa Rica
Study officials:
affiliation: Ohio State University
name: Steven J Schwartz, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03544216: Accommodative Relief for Uncomfortable Non-Presbyopes
Official title: Accommodative Relief for Uncomfortable Non-Presbyopes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthenopia
Keywords: Contact Lens
Multifocal
Accommodation
Presbyopia
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Bausch & Lomb Incorporated
First posted: 2018-06-01
Enrollment: 84
Sex: ALL
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will determine how multifocal contact lens correction affects symptoms of discomfort and asthenopia in a group of myopic contact lens wearers in the non-presbyopic age range (ages 30-40 years).

Detailed description: The purpose of this study is to determine how multifocal contact lenses affect contact lens comfort in non-presbyopic contact lens wearers. Current soft contact lens wearers who have symptoms of discomfort in their contact lenses will be recruited. Each subject (n = 84) will wear a single vision soft contact lens (Ultra single vision spherical lens) for two weeks and a low add power multifocal (Ultra for Presbyopia) for two weeks. Half of the subjects will wear the single vision lens first, and half of the subjects will wear the multifocal lens first. Initial lens group will be chosen randomly. Subjects will complete surveys that assess their vision and comfort which each lens, and ocular surface and accommodative/binocular vision status will be evaluated at the initial dispense and after wearing each lens for two weeks.

Eligibility criteria: Inclusion Criteria:

* Visual acuity of 20/25 or better in both eyes with habitual contact lenses
* -0.75 D or more myopic in both eyes
* -0.75 D or less astigmatism in both eyes
* Current single vision contact lens wearer who does not require a reading aid
* CLDEQ-8 score of 12 or more points with habitual contact lenses
* No history of ocular surgery or medication
* Reports digital device use of at least 3 hours per day
* No significant signs of dry eye (grade 1 or less ocular surface staining, Schirmer score of 7 mm or more, and tear break up time of 7 seconds or more in bother eyes)
* No significant binocular vision disorders in both eyes (eso or exophoria of 4 prism diopters or less at distance and near, near point of convergence of 6 mm or less, no history of strabismus or patching)

Primary outcomes:
measure: Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score
timeFrame: Baseline and after 2 weeks of contact lens wear with each study lens (single vision and multifocal)
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University College of Optometry
state: Ohio
Study officials:
References:
Clinical trial NCT01421316: Hair-sparing Whole Brain Radiotherapy
Official title: Reducing Hair Loss With Volumetric Arc Therapy in Patients Treated With Whole Brain Radiotherapy: a Phase II Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Brain Metastases
Small Cell Lung Cancer
Keywords: Patients treated with whole brain radiotherapy in the setting of brain metastases
Patients treated with whole brain radiotherapy in the prophylactic treatment for small cell lung cancer (extended disease).
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2011-08-22
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Up to 10% of patients with cancer will develop symptomatic brain metastases. Given this limited survival it is important to consider quality of life (QOL) when treating these patients. Whole brain radiotherapy (WBRT) can increase survival to 6 month. However, WBRT itself has been shown to reduce QOL by increasing drowsiness, leg weakness and hair loss in patients with brain metastases. Both fatigue and hair loss were reported to have the largest decline in QOL scores when WBRT is used in the prophylactic setting in small cell lung cancer. Recent technological improvements in patient positioning and treatment planning will allow us to treat the whole brain with reduced margins, allowing better sparing of the scalp. In view of the large impact of hair loss on quality of life, the investigators hypothesize to see an improved quality of life with scalp sparing techniques.

Study hypothesis: Volumetric arc therapy results in a reduced hair loss and a subsequent clinically important improvement in QOL.


Eligibility criteria: Inclusion Criteria:

* Brain metastases
* Age ≥ 18 years.
* Signed informed consent
* Recursive Partitioning Analysis (RPA) class III patients
* Recursive Partitioning Analysis (RPA) class I-II patients and \>3 brain metastases
* Patients with small cell lung cancer extended disease eligible for prophylactic Whole-Brain Radiotherapy (WBRT).

Exclusion Criteria:

* Previous whole brain radiotherapy

Primary outcomes:
measure: The European Organization for Research and Treatment of Cancer (EORTC)quality of life questionnaire (C15-PAL and BN20) measured at 1 month following treatment.
timeFrame: At 1 month.
Secondary outcomes:
measure: Hair quality before treatment and at 1 month following treatment.
timeFrame: at 1 month following treatment
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital, Belgium
Study officials:
References:
Clinical trial NCT00849316: Safety and Efficacy Study of NovoRapid™ in Patients With Coexisting Diabetes and Kidney Disease
Official title: A Multicenter, Open Label, Nonrandomized, Non Interventional, Observational, Safety and Efficacy Study of NovoRapid™(Insulin Aspart) in Patients With Coexisting Diabetes and Kidney Disease in India. The NovoRapid™ Nephropathy Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Chronic Kidney Disease
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-02-23
Enrollment: 0
Sex: ALL
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: Patients from both speciality practice settings who have been deemed appropriate to receive NovoRapid™ as new treatment and as part of routine out-patient care by the prescribing physician.

Brief summary: This study is conducted in Asia. The aim of this observational study is to investigate the clinical safety profile and effectiveness while using SC NovoRapid™ (insulin aspart) in patients with coexisting diabetes and kidney disease under normal clinical practice conditions in India.


Eligibility criteria: Inclusion Criteria:

* Any subject with coexisting kidney disease and type 1 or type 2 diabetes is eligible for the study, including: newly-diagnosed subjects, insulin naïve and subjects who have received insulin or an insulin analogue before
* Subjects with kidney disease (stage I-IV) including transplant patients will be eligible for the study, if initiated with NovoRapid™"

Exclusion Criteria:

* Subjects who are unlikely to comply with protocol requirements, e.g., uncooperative attitude, inability to return for the final visit
* Subjects with stage V of chronic kidney disease
* Subjects who previously enrolled in this study
* Known or suspected allergy to trial product(s) or related products

Primary outcomes:
measure: Incidence of major hypoglycaemic episodes
timeFrame: during 26 weeks
Secondary outcomes:
measure: Number of serious adverse events
timeFrame: during 26 weeks
measure: Number of serious adverse drug reactions
timeFrame: during 26 weeks
measure: Number of all daytime and nocturnal major hypoglycaemic events
timeFrame: during 26 weeks
measure: Number of major hypoglycaemic events related to omission of a meal after injection
timeFrame: during 26 weeks
measure: Number of all minor (daytime and nocturnal) hypoglycaemic events
timeFrame: during 4 weeks proceeding each study visits during Insulin Aspart (NovoRapidTM) therapy
Other outcomes:
Locations:
Study officials:
affiliation: Novo Nordisk India Ltd
name: Ankit Pathak, MD
role: STUDY_DIRECTOR
affiliation: Novo Nordisk India Private Ltd.
name: Ashok Moharana, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05771116: Erector Spinae Catheter Versus Paravertebral Catheter for Postoperative Analgesia in Cancer Patients Post Mastectomies
Official title: Erector Spinae Catheter Versus Paravertebral Catheter for Pain Management in Modified Radical Mastectomy for Cancer Patients: A Randomized Double-Blind Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Operative Pain
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 70
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: All patients admitted in National Cancer institute, Cairo University for breast surgeries will be investigated for inclusion criteria in the current study. And will be enrolled if fulfilled the criteria into 2 groups

.70 patients will be included in this prospective randomized study. The patients will be allocated into two groups: the ESPB group (group E, n = 35) , and the paravertebral group (group P, n =35)

* All patients will do Ultrasound-guided ESPB for group E and PVB for group P before receiving general anesthesia
* Postoperatively Patients in both groups will receive intravenous morphine 3 mg as rescue analgesic

Detailed description: * 70patients will be included in this prospective randomized study. The patients will be allocated into two groups: the ESPB group (group E, n = 35) , and the paravertebral group (group P, n =35)
* All patients will do Ultrasound-guided ESPB for group E and PVB for group P before receiving GA
* Postoperatively Patients in both groups will receive intravenous morphine 3 mg as rescue analgesic.
* Random numbers were generated using a computer-generated randomization code and were sealed in an opaque envelope. Randomization was conducted by a person who was not involved in the study.
* An independent observer who was blind to the group assignment checked the intraoperative and postoperative data.
* VAS pain score immediately postoperative and at 2,4,6, 8,12,18,24,36 ,48hrs.postoperative.

Eligibility criteria: Inclusion Criteria:

.Physical status ASA II.

. Patients (age 20-70yrs) scheduled for breast surgeries for breast cancer under general anesthesia

Exclusion Criteria:

.History of psychological disorders.

* Known sensitivity or contraindication to local anesthetics.
* Localized infection at the site of block.
* patients with coagulopathy or an (INR ≥ 2)

Primary outcomes:
measure: Total 48 hours Post-operative opioid consumption to keep VAS score ≤4.
timeFrame: 48 hours postoperative
Secondary outcomes:
measure: 1st request of analgesia
timeFrame: 48 hours postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: NCIEgypt
Study officials:
affiliation: National Cancer Institute, Egypt
name: suzan adlan, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03229616: BUCY+VP-16 vs BUCY Conditioning Regimen for DLBCL Undergoing Auto-HSCT
Official title: Busulfan+ Cyclophosphamide+ Etoposide vs Busulfan+ Cyclophosphamide Conditioning Regimen for Diffuse Large B-cell Lymphoma Undergoing Autologous Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Autologous Hematopoietic Stem Cell Transplantation
Diffuse Large B-cell Lymphoma
Conditioning
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Guangzhou First People's Hospital
name: Zhujiang Hospital
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Third Affiliated Hospital, Sun Yat-Sen University
name: Peking University People's Hospital
First posted: 2017-07-25
Enrollment: 122
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of BUCY+VP-16 and BUCY myeloablative conditioning regimens in diffuse large B-cell lymphoma undergoing autologous hematopoietic stem cell transplantation.

Detailed description: Autologous hematopoietic stem cell transplantation (Auto-HSCT) is an effective therapy for diffuse large B-cell lymphoma (DLBCL).BuCY conditioning regimen is a conventional scheme for DLBCL patients undergoing auto-HSCT, but it has a high relapse rate. Etoposide (VP-16) is extensively used in chemotherapy regimen for refractory/relapsed lymphoma. Whether addition of VP-16 could reduce the relapse rate remains unclear.In this study, the safety and efficacy of BUCY+VP-16 and BUCY myeloablative conditioning regimens in DLBCL undergoing auto-HSCT are evaluated.

Eligibility criteria: Inclusion Criteria:

* Diffuse large B-cell lymphoma patients
* Achieving CR or PR after four cycles of chemotherapy, then mobilizing and collecting of peripheral blood stem cells and receiving one cycle of chemotherapy

Exclusion Criteria:

* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (investigators' decision

Primary outcomes:
measure: relapse rate
timeFrame: 2 year
Secondary outcomes:
measure: DFS
timeFrame: 2 year
measure: OS
timeFrame: 2 year
measure: TRM
timeFrame: 2 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Hematology,Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Qifa Liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01340716: Effects of Tai Chi Chuan in Patients After Recent Acute Myocardial Infarction
Official title: Effects of Tai Chi Chuan on Blood Pressure, Respiratory Muscle Strength and Functional Capacity in Patients After Recent Acute Myocardial Infarction: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myocardial Infarction
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2011-04-22
Enrollment: 61
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized Clinical Trial to assess the effects of Tai Chi Chuan on blood pressure, respiratory muscle strength and functional capacity in patients after recent acute myocardial infarction.

Detailed description: Background:Patients with a recent myocardial infarction (MI) present a reduction in functional capacity expressed as a decrease in peak oxygen consumption (VO2 peak). The impact of a Tai Chi Chuan (TCC) cardiac rehabilitation program for patients recovering from recent MI has yet to be assessed. Our goal is to evaluate functional capacity after a TCC-based cardiac rehabilitation program in patients with recent MI.

Methods: A single-blind randomized clinical trial was conducted. The researchers who performed the tests were blinded to group allocation. Between the 14th and 21st days after hospital discharge, all patients performed a cardiopulmonary exercise testing and a laboratory blood workup. Mean age was similar (56 ± 9 years in the TCC group and 60 ± 9 years in the control group). Patients allocated to the intervention group performed 3 weekly sessions of TCC Beijin style for 12 weeks (n = 31). The control group participated in 3 weekly sessions of full-body stretching exercises (n = 30).

Eligibility criteria: Inclusion Criteria:

* Recent acute myocardial infarction
* Age 45 and 75 years.
* admission until 20 days after hospital discharge
* With physical conditions for a cardiac rehabilitation program with exercise.

Exclusion Criteria:

* Unstable angina
* Severe congestive heart failure
* Severe lung disease
* Altered response of blood pressure to stress

Primary outcomes:
measure: functional capacity
timeFrame: Change from Baseline in functional capacity at 90 days
Secondary outcomes:
measure: respiratory muscle strength
timeFrame: Change from Baseline in respiratory muscle strength at 90 days
measure: Ambulatory blood pressure in 24 hours
timeFrame: Change from Baseline in blood pressure at 90 days
Other outcomes:
Locations:
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Rosane Nery
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nery RM, Zanini M, de Lima JB, Buhler RP, da Silveira AD, Stein R. Tai Chi Chuan improves functional capacity after myocardial infarction: A randomized clinical trial. Am Heart J. 2015 Jun;169(6):854-60. doi: 10.1016/j.ahj.2015.01.017. Epub 2015 Mar 13.
Clinical trial NCT04637516: Evaluation of an Updated Version of the Program "BlinkBlink" for Alleviation of Dry Eye Symptoms Induced by Computer Work
Official title: Evaluation of an Updated Version of the Program "BlinkBlink" for Alleviation of Dry Eye Symptoms Induced by Computer Work
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndromes
Computer Vision Syndrome
Keywords: dry eye disease
computer work
computer vision syndrome
Lead sponsor: University of Applied Sciences and Arts Northwestern Switzerland
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Subjects use two versions of the program for a set duration, separated by a washout phase. The order of versions applied is randomised.
Primary purpose: TREATMENT

Brief summary: The program "BlinkBlink" was developed to alleviate dry eye symptoms during prolonged computer work. This study aimed to show subjective and objective improvement of dry eye problems in a sample size of office workers

Detailed description: The increased use of digital devices and the resulting increase in near work has increased the prevalence of dry eye disease (DED).

Studies show that blink frequency reduced considerably during computer work, hence the tear film is spread less regularly over the anterior surface of the eye giving rise to an unstable tear film. This may lead to tired, dry eyes.

The aim of this study was to observe if the tear film quality and dry eye symptoms may improve with the use of the computer animation program "BlinkBlink" during prolonged computer work. Participating subjects test two versions of the program, whereby one version applies the animation in a much lower frequency, hence serving as a near placebo version. The testing order of the versions is randomized.

The variables tested in this study are non-invasive tear film break up (NIBUT) and subjective dry eye symptoms with the Ocular Surface Disease Index (OSDI) questionnaire.

Eligibility criteria: Inclusion Criteria:

* duration of computer work of at least six hours per day during at least four days per week
* OSDI score ≥ 18
* no active pathology on the anterior eye
* Snellen visual acuity of ≥ 0.8.

Exclusion Criteria:

* acute systemic disease
* contact lens wear
* asthenopia

Primary outcomes:
measure: Subjective improvement of dry eyes
timeFrame: 14 days
measure: objective improvement of dry eyes
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Olten
country: Switzerland
facility: Institute of Optometry, FHNW
state: Solothurn
Study officials:
References:
citation: Nosch DS, Foppa C, Toth M, Joos RE. Blink Animation Software to Improve Blinking and Dry Eye Symptoms. Optom Vis Sci. 2015 Sep;92(9):e310-5. doi: 10.1097/OPX.0000000000000654.