louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01130129: The Effects of Plant Bioactives on Platelet Function
Official title: The Effects of Plant Bioactives on Platelet Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Flavonoids
Platelets
Lead sponsor: Quadram Institute Bioscience
Sponsor class: OTHER
Collaborators: name: European Union
First posted: 2010-05-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Consumption of a diet rich in fruit and vegetables is associated with a reduced risk of cardiovascular disease and the protective effect may be due to polyphenolic compounds contained within these foods. The mechanism by which polyphenols exert this effect is not clearly understood but research has focused on their potential to affect platelet function. The purpose of this study is to quantify the anti-clotting activity of a range of plant food extracts and component compounds.

Detailed description: A single sample of whole blood will be collected from 15 male or female volunteers aged between 18 and 65 years. After collection whole blood will be treated with a range of flavonoids to evaluate their effects on platelet function.

Eligibility criteria: Inclusion Criteria:

* Males and females
* Aged 18 - 65 years.
* BMI \> 19.5 and \< 35
* Non-smokers

Exclusion Criteria:

* Pregnancy or have been pregnant within the last 12 months
* Parallel participation in another research project which involves dietary intervention
* Participation in another research project which has involved blood sampling within the last four months unless the total amount of combined blood from both studies does not exceed 470 mls.
* Has donated or intends to donate blood within 16 weeks prior to during the Study period.
* Depressed or elevated blood pressure measurements (\<90/50 or 95/50 if symptomatic or \>160/100)
* Any person related to or living with any member of the study team
* Diabetics
* Taking regular prescribed and/or non-prescribed medication (excluding oral contraceptive and HRT).
* Known bleeding disorders.

Primary outcomes:
measure: Identification of flavonoids that exert a significant anti-clotting effect
timeFrame: within 4hours
Secondary outcomes:
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: Institute of Food Research
state: Norfolk
Study officials:
affiliation: Quadram Institute Bioscience
name: Paul Kroon, phD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01046929: Limonene Study in Women With Breast Cancer
Official title: Clinical Study of Limonene in Women With a Recent Diagnosis of Early Stage Breast Cancer Electing to Undergo Excision Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Keywords: limonene
breast cancer
cancer prevention
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-01-12
Enrollment: 59
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Limonene is a major component in the essential oils of citrus fruits. It has demonstrated promising breast cancer preventive and therapeutic effects in preclinical model systems. This early phase clinical study will evaluate the distribution of limonene to the breast tissue and its associated biological activities after 2 to 6 weeks of limonene dosing in women with a recent diagnosis of early stage breast cancer. This study will help evaluate the potentials of developing limonene as a breast cancer preventive agent.


Eligibility criteria: Inclusion Criteria:

* Women who are 18 years of age or older
* Women electing to undergo excision surgery for early stage breast cancer
* A minimum of 2 weeks from enrollment to definitive surgery
* Underwent core needle biopsy for breast cancer diagnosis
* No clinical evidence of metastatic breast cancer
* ECOG performance status 0-1
* Participants must have normal organ and marrow function
* Women of child-bearing potential must agree to use adequate contraception
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Concurrent chemotherapy or radiation therapy
* Use of selective estrogen receptor modifiers or aromatase inhibitors within the past 3 months or concurrently
* History of other malignancies within the past 5 years excluding non-melanoma skin cancer and cancers confined to organs with removal as only treatment
* Participated in another clinical intervention trial within the past 3 months
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant or breast-feeding women
* Use of dietary supplement that contains large amounts of d-limonene (such as Heartburn Free with ROH10 and CoQ with d-limonene) within the past 3 months

Primary outcomes:
measure: breast tissue limonene level
timeFrame: 2 - 6 weeks
Secondary outcomes:
measure: drug effect biomarkers in the breast tissue and serum
timeFrame: 2 - 6 weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
Study officials:
References:
Clinical trial NCT04589429: Adding Nalbuphine for Control of Intrathecal Morphine Pruritus
Official title: Does Adding Nalbuphine to Intrathecal Morphine Reduce Morphine Induced Pruritus? A Randomized, Double Blind, Controlled Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pruritus
Pain, Postoperative
Nausea, Postoperative
Vomiting, Postoperative
Keywords: pruritus
intrathecal morphine
intrathecal nalbuphine
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 70
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: PREVENTION

Brief summary: Intrathecal morphine causes intense itching which is very bothersome. Nalbuphine antagonizes this effect when given intravenously. This trial is to find out if nalbuphine added to intrathecal morphine has an effect on morphine related pruritus while still maintaining adequate analgesia.

Detailed description: The study will be performed in MiniaUniversity Hospitals, after obtaining approval from the local ethics committee. All patients will have a peripheral IV cannula 18 G inserted; standard non-invasive monitors will be applied. Patients undergoing major abdominal surgery will be divided into 2 groups to receive intrathecal morphine 300 micrograms with or without nalbuphine 1mg prior to anesthesia. General anesthesia is then given to patients.

Eligibility criteria: Inclusion Criteria:

* Male and female patients.
* Age 18-80yrs.
* Elective major abdominal surgery under general anesthesia.

Exclusion Criteria:

* Refusal to participate.
* Skin or systemic disease with itching. Any condition which precludes performing spinal injection

Primary outcomes:
measure: pruritus
timeFrame: 2 hours postoperatively
measure: pruritus
timeFrame: 4 hours postoperatively
measure: pruritus
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: postoperative pain
timeFrame: 2 hours postoperative
measure: postoperative pain
timeFrame: 4 hours postoperative
measure: postoperative pain
timeFrame: 24 hours postoperative
measure: postoperative nausea and vomiting
timeFrame: 2 hours postoperative
measure: postoperative nausea and vomiting
timeFrame: 4 hours postoperative
measure: postoperative nausea and vomiting
timeFrame: 24 hours postoperative
measure: Sedation
timeFrame: 2 hours postoperative
measure: Sedation
timeFrame: 4 hours postoperative
measure: Sedation
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: anesthesia&ICU department
Study officials:
affiliation: Anesthesia and ICU department, Faculty of Medicine, Minia University
name: Sohair A Megalla, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01162629: Vertical Augmentation With Osteon at Dental Implant Placement
Official title: An Evaluation of Vertical Augmentation of Alveolar Bone With Osteon at Dental Implant Placement
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tooth Injuries
Tooth Abnormalities
Keywords: bounded saddles
missing teeth
dental implants
Tooth, Nonvital
Lead sponsor: Research and Education in Dentistry
Sponsor class: OTHER
First posted: 2010-07-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Private specialist dental implant clinic

Brief summary: Dental implants are a valid and reliable method to replace missing teeth. The major requirement for their success is an adequate volume of bone into which they can be placed. One widely used method to augment bone at the time of placing the implant is to use a bone substitute rather than taking a block bone graft from the patient. Successful augmentation in the vertical direction has often proved difficult, however, the investigators have developed a technique to achieve this in the investigators patients using a synthetic bone substitute, Osteon (Implantium, CE0120) in an attempt to avoid patients having to undergo another unnecessary surgical procedure.

Detailed description: Primary Objective

• To determine the success of dental implants in alveolar bone augmented in the vertical direction with Osteon.

Secondary Objectives • To determine the long term success of dental implants in this augmented bone.

Primary Endpoint

• Radiographically assessed vertical height of alveolar ridge formation following Osteon augmentation.

Eligibility criteria: Inclusion Criteria:

* missing one or two teeth
* bounded saddle
* healthy (ASA grade I \& II) adult

Exclusion Criteria:

* smoker
* significant medical problem (ASA III or above)

Primary outcomes:
measure: The success of dental implants in alveolar bone augmented in the vertical direction with Osteon
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shrewsbury
country: United Kingdom
facility: Oracle Dental Clinics
state: Shropshire
Study officials:
affiliation: Research and Education in Dentistry
name: Richard J Oliver, BDS PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00965029: Spirometry in Mechanically Ventilated Chronic Obstructive Pulmonary Disease (COPD) Patients
Official title: Spirometry in Mechanically Ventilated COPD Patients: Correlation of Lung Function Tests to Successful Weaning From Mechanical Ventilation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD
Keywords: COPD
Spirometry
Weaning
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-08-25
Enrollment: 100
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: COPD patients with respiratory failure due to COPD exacerbation, and on mechanical ventilation

Brief summary: Patients with COPD who deteriorate to Respiratory Failure pose a challenge to the intensivist both in ventilating an obstructed patient and in weaning from mechanical ventilation.

Currently there are no accepted extubation criteria in COPD patients that could predict successful weaning from mechanical ventilation. In this study we will attempt to correlate spirometric data to eventual weaning from mechanical ventilation.

Detailed description: COPD patients who deteriorate to Respiratory Failure will be recruited. Sedation will be interrupted daily, and each day once the patient is awake and cooperative, spirometry will be performed. FEV1 and FVC will be recorded and later correlated to eventual rate of successful extubation.

Eligibility criteria: Inclusion Criteria:

* \>18
* Mechanically ventilated due to COPD exacerbation

Exclusion Criteria:

* decreased level of consciousness
* uncooperative patient
* Bronchial asthma

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beer Yaakov
country: Israel
facility: Arie Soroksky
state: Zerifin
Study officials:
affiliation: General ICU, Assaf Harofe MC, Zerifin, Israel
name: Arie Soroksky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06304129: Diagnostic Performance of Plasma Biomarkers of Alzheimer's Disease Compared With CSF Markers
Official title: Threshold Values and Diagnostic Performance of Plasma Biomarkers of Alzheimer's Disease Compared With CSF Markers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alzheimer Blood Biomarkers
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: Thérèse Jonveaux
name: Laure Joly
name: Lucie Hopes
name: Maia Simon
name: Franck Schreiner
First posted: 2024-03-12
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: .The goal of this interventional study is to estimate the diagnostic performance of plasma biomarkers of interest (Aβ40 and Aβ42, P-Tau and NFL), enabling discrimination between patients with and without a pathophysiological AD process. The main questions it aims to answer are:

* to define a threshold value for each of the plasma,
* to describe the correlations between the plasma biomarkers of interest and the other biological analyses performed as part of care, in particular triglyceridemia, cholesterolemia, glycemia and proteinemia,
* to describe biomarker results in relation to comorbidities, in particular dyslipidemia and diabetes
* to describe the final diagnosis and results obtained for plasma biomarkers, for patients with intermediate results according to the A/T/N classification (A-/T+ or A+/T-) Participants will be selected among patients undergoing lumbar puncture for the differential diagnosis of AD at Nancy University Hospital.


Eligibility criteria: Inclusion Criteria:

* Man or woman aged 18 or over
* Person affiliated to a social security scheme or beneficiary of such a scheme
* Person who has received full information on the organization of the research and has signed an informed consent form
* Person whose care requires a lumbar puncture to measure markers of Alzheimer's disease

Exclusion Criteria:

* Adult subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
* An adult unable to give consent
* Persons deprived of their liberty by judicial or administrative decision
* Persons under psychiatric care under articles L. 3212-1 and L. 3213-1.
* Pregnant, parturient or breast-feeding women
* Persons staying in a health or social establishment for purposes other than research.

Primary outcomes:
measure: Aβ40 and Aβ42, P-Tau, Tau and NFL
timeFrame: 2 years
Secondary outcomes:
measure: Sensitivity/specificity
timeFrame: 2 years
measure: Co-mobidity
timeFrame: 2 years
measure: Final diagnosis
timeFrame: 2 years
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU De Nancy
state: Grand Est
Study officials:
affiliation: CHRU Nancy
name: Catherine Malaplate, PhD, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004729: Ketogenic Diet for Child Epilepsy and Seizure Control
Official title: Efficacy of the Ketogenic Diet -- a Blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Seizures
Lennox-Gastaut Syndrome
Keywords: child
children
epilepsy
seizure
ketogenic
diet
Lennox-Gastaut Syndrome
LGS
Lead sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Sponsor class: NIH
First posted: 2000-02-28
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: Twenty to thirty percent of children with epilepsy continue to suffer from seizures, even when treated with currently available anticonvulsant medications. Children with Lennox-Gastaut Syndrome (LGS) are particularly handicapped by atonic-myoclonic seizures. Preliminary data suggest that even when other medications have failed, these seizures may respond rapidly and dramatically to a high-fat-low-carbohydrate ketogenic diet. The purpose of the study is to assess if the classic ketogenic diet is efficacious in reducing seizure frequency, medication toxicity, and improves quality of life.

Detailed description: The ketogenic diet (KD) is a form of therapy for seizures that involves a brief period of fasting followed by a very carefully controlled high fat-low protein and carbohydrate diet. Studies suggest it is useful in children whose seizures could not be controlled by any of the medicines available. This study is designed to test, in a carefully controlled fashion, how well the diet works in children with "drop" seizures. Children who experience 15 or more drop seizures each day, despite having used at least two medications, may be eligible to participate. This study requires children to undergo periods of fasting and to maintain a carefully controlled diet. Parents of participating children monitor their children's diets and keep daily meal and seizure diaries.

Eligibility criteria: Inclusion Criteria:

* \>15 myoclonic or atonic seizures a day
* EEG with Lennox-Gastaut pattern

Exclusion Criteria:

* \<15 atonic or myoclonic seizures a day
* on \>3 medications
* previously on diet and/or evidence of metabolic disorder

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: John M. Freeman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02496429: Evaluation of the Reliability and Usability of the Reusable "BrownieForSymphony" Pump Set
Official title: ESP Evaluation of the Reliability and Usability of the Reusable "BrownieForSymphony" Pump Set
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lactation
Lead sponsor: Medela AG
Sponsor class: INDUSTRY
First posted: 2015-07-14
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary objectives of this study is to evaluate how professionals rate the reliability and usability of the reusable BrownieForSymphony pump set.and the current used Symphony pump set

4.2 Secondary Objectives

The secondary objectives of this study are:

* to evaluate the rate of usability problems with the BrownieForSymphony pump set
* to evaluate the pragmatic quality (task/goal fulfilment) of the BrownieForSymphony pump set
* to evaluate first impression of lactating woman regarding pumping with the BrownieForSymphony pump set

Detailed description: This is a 5 day case study to evaluate the reliability and usability of the BrownieForSymphony pump set.

The study consists of two different participant groups, professionals (e.g. lactation consultants, nurses) and lactating women.

Eligibility criteria: Inclusion Criteria:

* Hospitalized lactating woman \>18 years which are pumping breast milk

Exclusion Criteria:

* hospitalized lactating woman has a medical indication for pumping (e.g. Mastitis, cracked nipples) lactating woman used a breast shield size \>27 and \<24

Primary outcomes:
measure: Usability Scale (SUS) Symphony Pumpset usability
timeFrame: day at inclusion
measure: Usability Scale (SUS) BrownieForSymphony Pumpset usability
timeFrame: after 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinik Dr. Geißenhofer
city: Tuebingen
country: Germany
facility: University Tuebingen
Study officials:
affiliation: Medela AG
name: Danielle Prime, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05583929: Walking Ability and Limit of Stability in Children With Spastic Cerebral Palsy
Official title: an Investigation of the Relationship Between Walking Ability and Limit of Stability in Children With Spastic Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gait, Spastic
Keywords: gait, walking ability, limit of stability, cerebral palsy
Lead sponsor: Muş Alparslan University
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Spastic cerebral palsy and their developing peers

Brief summary: Trunk control in children with spastic Cerebral Palsy (CP) is impaired. They have weaker trunk muscle strenght, and insufficient sitting/standing balance according to their developing peers. Since their weak trunk muscles and insufficient balance responses, they are not able to walk as functional similar to their peers. Additionaly limit of stability is worsen in children with CP. Investigation of the relationship between walking ability and limit of stability when seated position is important to understand which child is acceptable for training of walk. However we did not found any study to explain it. Therefore the aim of this study is to investigate walking ability and limit of stability in children with spastic CP, and to compare their developing peers.


Eligibility criteria: Inclusion Criteria:

* spastic serebral palsy, between the ages 6-15 years, between the I-IV. levels of GMFCS, be able to understand command given by physical therapist

Exclusion Criteria:

* undergone botulinum toxin A to upper and/or lower extremities, undergone any surgery to their extremities, be at the V. levels of GMFCS

Primary outcomes:
measure: Gait parameters (stride length in cm, step width in cm, time in swing phase in second, time in stance phase in second)
timeFrame: 20 minutes
measure: Limit of stability when sitting and standing position in cm
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Altındağ
country: Turkey
facility: Hacettepe University
state: Ankara
Study officials:
affiliation: Hacettepe University
name: Bayram Sırrı, MSc
role: PRINCIPAL_INVESTIGATOR
References: