louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02735486: Acute Effects of Ginger Extract Consumption on Risk Markers of Cardiovascular Disease
Official title: Randomized, Controlled Trial of Ginger Extract Consumption for Healthy Males at Risk of Developing Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: Ginger
blood pressure
flow mediated dilatation
Lead sponsor: University of Reading
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 22
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The primary aim of the study was to investigate the acute effect of ginger drink consumption on the risk markers of cardiovascular disease.

Detailed description: A randomized, single-blind human intervention study involving 22 healthy male volunteers was designed to investigate the acute effects of ginger drink consumption on risk markers of cardiovascular disease (CVD). The primary outcome measure is reduction in blood pressure while the secondary outcome measures are improvement in flow mediated dilatation (FMD) and changes in plasma biochemical profile parameters related to CVD. Participants were given 300 ml of ginger extract or water (placebo) with breakfast, followed by a lunch at 2 hours on two visits separated by 2 weeks. Blood and urine samples were collected at regular intervals as well as blood pressure measurement done during the two visits. Vascular function was measured by flow mediated dilatation (FMD) and pulse wave velocity (PWV) at baseline, 2 and 4 hours after the the consumption of the study drink and placebo. The blood and urine samples were analysed for changes in lipid profile and other markers of CVD.

Eligibility criteria: Inclusion Criteria:

* Apparently healthy males,
* Age (30 - 65) years,
* Not diabetic or plasma glucose \> 7 or on anti-diabetic drugs and not on anti- hypertensive drugs.
* Subjects \< 10% risk of cardiovascular disease

Exclusion Criteria:

* Women,
* Men younger than 30 years and older that 65 years,
* Men who are sick or on anti-diabetic and anti-hypertensive drugs.
* Men who have history of heart attack or stroke within the last 12 months
* Men who are on lipids lowering drugs

Primary outcomes:
measure: Reduction in blood pressure (BP)
timeFrame: Six (6) hours
Secondary outcomes:
measure: Flow mediated dilatation
timeFrame: Six (6) hours
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: Department of Food and Nutritional Sciences
state: Berkshire
Study officials:
affiliation: University of Reading
name: Jeremy PE Spencer, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03155386: Optimized Angiomammography and Comparison With Standard Angiomammography
Official title: Evaluation of the Clinical Performance of Optimized Angiomammography and Comparison With Standard Angiomammography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients for Whom an Angiomammogram Examination is Requested Whether Its Indication
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2017-05-16
Enrollment: 100
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients for whom an angiomammographic examination is requested regardless of its indication

Brief summary: This study will be proposed consecutively to any patient who angiomammography examination was requested by the clinician in charge of patient. A randomization will be performed between an angiomammography examination Standard (SenoBright®) and an optimized angiomammography examination.

A blinded central re-reading of the acquisition technique will be carried out by 3 radiologists (2 seniors and 1 junior) who will evaluate:

* The intensity of lesion enhancement
* The presence and type of artefacts on the recombined images.
* The quality of low-energy images according to recognized criteria for mammography.

The gold standard will be histology (biopsies or surgery) or follow-up to 1 year for non-biopsied benign lesions


Eligibility criteria: Inclusion Criteria:

1. Patient for whom angiomammography examination is requested regardless of its indication (assessment of extension, clarification of a lesion doubtful after mammography and mammary ultrasound, symptom mammary MRI in a patient with contraindication to MRI)
2. Patient aged 40 to 70 years
3. Informing the patient or his / her legal representative and signing the form of non-opposition.
4. Patient affiliated to a social security system.

Exclusion Criteria:

1. Patient with breast prostheses
2. Patient with a genetic mutation (BRCA1, BRCA2, p57)
3. Contraindication to injection of iodinated contrast agent
4. Pregnant woman, likely to be pregnant or breastfeeding,
5. Persons deprived of their liberty or under guardianship,
6. Unable to undergo medical follow-up of the trial for reasons geographical, social or psychological.

Primary outcomes:
measure: artefact presence rate
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy
state: Val de Marne
Study officials:
References:
Clinical trial NCT01088386: Zyprexa® Relprevv™ Patient Care Program
Official title: Zyprexa® Relprevv™ Patient Care Program
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Schizophrenia
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2010-03-17
Enrollment: 4000
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: Clinical practices in the United States

Brief summary: The goal of the Zyprexa Relprevv Patient Care Program is to mitigate the risk of negative outcomes associated with Zyprexa Relprevv post-injection delirium/sedation syndrome (PDSS).

Detailed description: The goal of the Zyprexa Relprevv Patient Care Program is to mitigate the risk of negative outcomes associated with Zyprexa Relprevv post-injection delirium/sedation syndrome (PDSS) by:

1. Ensuring Zyprexa Relprevv is prescribed only by certified prescribers, dispensed only by certified dispensers, and dispensed for use only in certified healthcare facilities with ready access to emergency response services, and dispensed for use only with documentation of safe use conditions;
2. Informing health care providers and patients about the risks and the need for continuous observation of patients for at least 3 hours in certified healthcare facilities; and
3. Establishing long-term safety and safe use of Zyprexa Relprevv through periodic monitoring for the risk of PDSS events and by enrolling all patients who receive Zyprexa Relprevv in the Zyprexa Relprevv Patient Care Program registry.

Eligibility criteria: Inclusion Criteria:

* Any patients receiving Zyprexa Relprevv enrolled in Zyprexa Relprevv Patient Care Program

Exclusion Criteria:

* Any patient not receiving Zyprexa Relprevv

Primary outcomes:
measure: Incidence per injection and per patient of post-injection delirium/sedation syndrome (PDSS) events
timeFrame: Baseline to end of study
Secondary outcomes:
measure: Type of post-injection delirium/sedation syndrome (PDSS) by clinical presentation and outcome
timeFrame: Baseline to end of study
measure: Potential risk factors of post-injection delirium/sedation syndrome (PDSS).
timeFrame: Baseline to end of study
Other outcomes:
Locations:
city: Blue Bell
country: United States
facility: United BioSource Corporation
state: Pennsylvania
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02773186: Cerebral Oximetry With Near-infrared Spectroscopy and Negative Postoperative Behavioral Changes in Pediatric Surgery
Official title: Cerebral Oximetry With Near-infrared Spectroscopy and Negative Postoperative Behavioral Changes in Pediatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Dysfunction
Keywords: postoperative
behavioral changes
Lead sponsor: Hospital Clínico Universitario de Valladolid
Sponsor class: OTHER
First posted: 2016-05-16
Enrollment: 198
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This prospective and observational study involved consecutive patients aged between 2 and 12 years undergoing a major surgery using general anesthesia.Children undergoing urological and general surgery also required of locoregional blockade. Anesthetic induction was achieved with high concentration sevoflurane 6-8% (Sevorane®, Abbvie) and oxygen 50%. Anesthetic maintenance was done with sevoflurane 2-3%, 50% O2/air mixture, fentanyl 1 µg.kg.-1 iv, and rocuronium 0.3 µg.kg.-1 iv if required. Electrocardiogram (ECG), non-invasive arterial pressure, pulse oximetry, end-tidal carbon dioxide and cerebral NIRS oximetry was monitoring by using an INVOSTM5100 (Somanetics Corporation, Troy, MI, USA)

Brief summary: The main objective of the present study was to evaluate whether cerebral oxygen saturation is associated with an increase of NPOBC in pediatric patients undergoing major surgery.

Detailed description: This prospective and observational study involved consecutive patients aged between 2 and 12 years undergoing a major surgery using general anesthesia. Cerebral oxygen saturation, non-invasive arterial pressure, pulse oximetry, and heart rate were recorded at the following stages of the surgical intervention: baseline, induction, intubation, surgical incision, end of surgery, and extubation. Preoperative anxiety was evaluated by using the modified Yale Preoperative Anxiety Scale, and NPOBC was determined by using the Post-Hospital Behaviour Questionnaire on 7th and 28th postoperative days. A logistic regression was created to identify factors associated with the development of NPOBC

Eligibility criteria: Inclusion Criteria:

* Patients aged between 2 and 12 years undergoing major surgery using general anesthesia.

Exclusion Criteria:

* Children aged below 2 or over 12.
* Neuropsychiatric disorder, or undergoing an emergency surgery.

Primary outcomes:
measure: Incidence of Negative Postoperative Behavioral Changes
timeFrame: on 7th and 28th postoperative days
Secondary outcomes:
measure: Number of children with cerebral desaturation and NPOBC
timeFrame: on 7th and 28th postoperative days
Other outcomes:
Locations:
Study officials:
name: Eduardo Tamayo Gómez, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02262286: MIND (Management of Traumatic Brain Injury Diagnosis)
Official title: Study to Procure Human Specimens for Use in the Diagnosis and Management of Traumatic Brain Injury and Other Related Conditions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Injury
Keywords: Brain Injury
Lead sponsor: Abbott Diagnostics Division
Sponsor class: INDUSTRY
First posted: 2014-10-13
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals presenting to the ED within 6 hours of experiencing a head trauma, or bone fractions only.

Brief summary: Procure blood specimens from individuals presenting to the emergency department with suspected brain injury.


Eligibility criteria: Inclusion Criteria:

* Informed Consent Form Signed
* 18 years of age or older
* For women of child-bearing age: Not known to be pregnant AND
* Head Trauma within 6 hours of ED presentation with Glasgow Coma Scores from 3-8 (Severe Injury), 9-13 (Moderate Injury), or 14-15 (Mild Injury); OR
* Head trauma within 6 hours of ED presentation with Glasgow Coma Score of 15; OR
* Bone fracture or poly-traumas, both with no head trauma

Exclusion Criteria:

* Known pre-existing neurological condition that causes observed symptoms
* Recent history of head injury or seizures (within 1 year of current ED presentation)
* Prisoner

Primary outcomes:
measure: Measurement of specific biomarker(s) for brain injury
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum rechts der Isar
Study officials:
affiliation: Klinikum reichs der Isar
name: Peter Biberthaler, MD/PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01315886: Conversion From Fast Acting Oral Opioids to Abstral®
Official title: Conversion From Fast Acting Oral Opioids to Abstral® (SL Fentanyl) in Opioid Tolerant Cancer Patients With Breakthrough Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain
Keywords: sublingual
fentanyl
titration
conversion
breakthrough cancer pain
pain intensity difference
PID
Edmonton Symptom Assessment System
ESAS
Lead sponsor: Orexo AB
Sponsor class: INDUSTRY
First posted: 2011-03-15
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate safety and efficacy when using a novel dose conversion strategy to switch from immediate release oral opioids to sublingual (SL) fentanyl (Abstral) for treatment of breakthrough cancer pain (BTcP).

Detailed description: The study aims to show that in the advanced stage of cancer the individual patient already on high doses of BTcP medication will benefit from starting treatment on a higher first dose of SL fentanyl thus reducing the number of dosing steps with insufficient pain relief.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent obtained.
* 18 years or older, of both genders.
* Opioid tolerant patients
* Estimated frequency of BTcP 0.5-4 times a day.

Exclusion Criteria:

* Treatment with SL fentanyl within two weeks prior to screening.
* Recent or planned therapy that would alter pain or responses to analgesics.
* Treatment with monoamine oxidase inhibitor \< 14 days before or concurrent with SL fentanyl treatment.
* Significantly reduced liver and/or kidney function.
* Significant prior history of substance abuse.
* Pregnancy, breast feeding or woman of childbearing potential not using adequate birth control.

Primary outcomes:
measure: Response rate in patients converted to SL fentanyl.
timeFrame: 30 minutes post dose
Secondary outcomes:
measure: Responder rate in patients converted to SL fentanyl as assessed by the PID15.
timeFrame: 15 minutes post dose
measure: Edmonton Symptom Assessment System (ESAS) Symptom Distress Score (SDS)
timeFrame: 24 hour assessment on days with pain episodes
measure: Patient's global assessment of treatment (patient satisfaction).
timeFrame: 2 occasions
measure: Patients preference of treatment (baseline treatment/SL fentanyl).
timeFrame: end of study
measure: Occurrence of AEs, withdrawals
timeFrame: during a maximum treatment period of 21 days.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Smärtavdelning B42, Anestesikliniken Karolinska University Hospital, Huddinge
Study officials:
affiliation: Orexo AB
name: Anders Pettersson, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02736786: A Study of Mucosal Sparing Proton Beam Therapy (PBT) in Resected Oropharyngeal Tumors
Official title: A Study of Mucosal Sparing Proton Beam Therapy (PBT) in Resected Oropharyngeal Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oropharyngeal Tumor
Keywords: proton
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-04-13
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Oropharyngeal cancer resected using transoral surgery with positive lymphadenopathy requiring adjuvant radiation therapy.

Brief summary: This study is an observational study evaluating the clinical outcomes of mucosal sparing proton beam therapy (PBT) after resection of favorable risk oropharyngeal cancer patients. Subjects will be screened at outpatient clinic visit appointments and interested qualified subjects will be consented and offered participation in this study. Once consent has been obtained baseline adverse event and Quality of Life (QOL) data will be collected and subjects will undergo adjuvant PBT and follow-up at 3 months, 12 months, and 24 months. No study-specific visits or evaluations will be required. Patients will be evaluated according to the physician's standard practice and discretion. Patient data will be drawn from the patients' medical records and reported by means of a web-based electronic data collection (EDC) system. Patients will be considered "on study" until 24 months of observation has occurred, withdrawal of consent, lost to follow-up, or study closure.


Eligibility criteria: Inclusion Criteria:

* Resection of oropharyngeal tumor by transoral surgery using frozen section margin analysis resulting in a negative margin resection
* No extensive perineural invasion after review by head and neck pathologist
* No lymphovascular invasion after review by head and neck pathologist
* Pathologic stage T1-2 N1-3 M0 disease

Exclusion Criteria:

* T3 or T4 primary stage disease
* Prior radiation therapy to the head and neck

Primary outcomes:
measure: Local Control Rate in Patients Treated with Proton Beam Therapy after Resection Using Transoral Surgery
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References:
Clinical trial NCT02900586: Behavior and Knowledges of Patients Enrolled Into SIOUX Study
Official title: Understand the Behavior and the Knowledges of Patients Enrolled Into SIOUX Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
Collaborators: name: University of Lorraine
First posted: 2016-09-14
Enrollment: 20
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: Osteoporotic patients who have been enrolled into SIOUX study

Brief summary: The purpose of this study is to contribute to the evaluation of SIOUX study by adding data about the choices of the observant patients, the mis-observant ones or the protocol deviations.

Detailed description: The adherence to treatment for osteoporosis doesn't exceed 50% after one year. The SIOUX project about the inter-professional collaboration (attending physician with dispensary pharmacist) developed therapeutic patient education (TPE) plans and created follow-up booklets which were dealt to the patients who have to transmit it to their two medical professionals twice a year during three years one after one. The results after 18 months are encouraging about the improvement of adherence to treatment and about the lifestyle changes.

Eligibility criteria: Inclusion Criteria:

* patients enrolled into SIOUX study

Exclusion Criteria:

* cognitive troubles which prevent the patient to participate in individual interview

Primary outcomes:
measure: Medication management
timeFrame: year 1
Secondary outcomes:
Other outcomes:
Locations:
city: Metz Cedex 03
country: France
facility: Hôpital de Mercy - CHR Metz-Thionville
Study officials:
affiliation: CHR Metz-Thionville
name: Didier POIVRET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04522986: An Exploratory Study of ADR-001 in Patients with Severe Pneumonia Caused by SARS-CoV-2 Infection
Official title: An Exploratory Study of ADR-001 in Patients with Severe Pneumonia Caused by SARS-CoV-2 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Severe Acute Respiratory Syndrome Coronavirus 2
Lead sponsor: Rohto Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-08-21
Enrollment: 6
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Safety and efficacy of ADR-001 are evaluated in Patients with Severe Pneumonia caused by SARS-CoV-2 infection.

Detailed description: Patients with Severe Pneumonia caused by SARS-CoV-2 infection are enrolled to the study. Adipose-derived mesenchymal stem cells (AD-MSCs) are administered once a week, total four times intravenously. Safety and efficacy of AD-MSCs are evaluated for 12 weeks after first administer.

Eligibility criteria: Inclusion Criteria:

* SARS-CoV-2 infection is confirmed on antigen test or PCR test
* Pulmonary infiltrative shadow is confirmed on chest X-ray test
* Mechanical ventilation is being utilized, or Acute Respiratory Failure whose PaO2 is not being achieved to 80 mmHg in spite of High-flow oxygen therapy

Exclusion Criteria:

* Continue treatment for Pneumonia before SARS-CoV-2 infection
* SOFA score \>= 15
* Infection type on DIC diagnosis criteria \>= 4
* Deep Venous Thrombosis

Primary outcomes:
measure: Safety: Adverse Event
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
Study officials:
affiliation: Osaka University Hospital
name: Yuji Fujino, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004386: Phase I Pilot Study of Liver-Directed Gene Therapy for Partial Ornithine Transcarbamylase Deficiency
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Ornithine Transcarbamylase Deficiency Disease
Keywords: inborn errors of metabolism
rare disease
urea cycle disorder
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Children's National Research Institute
First posted: 1999-10-19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

Evaluate the safety and feasibility of administering recombinant adenovirus containing the ornithine transcarbamylase gene to adults with partial ornithine transcarbamylase deficiency.

Detailed description: PROTOCOL OUTLINE: This a dose escalation study to estimate the maximum tolerated dose of recombinant adenovirus encoded with the ornithine transcarbamylase gene.

Patients receive a single dose of virus infused into the liver under fluoroscopic guidance. Groups of 3 patients receive successively higher doses of virus; each cohort is observed for safety for 3 weeks before entry of the next group.

Patients are followed weekly for 1 month, then every 3 months until stable.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Confirmed partial ornithine transcarbamylase deficiency Asymptomatic, i.e., at least 1 month since hyperammonemia --Prior/Concurrent Therapy-- Not specified --Patient Characteristics-- No pregnant or nursing women Negative pregnancy test required of fertile women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Children's National Research Institute
name: Mark Batshaw
role: STUDY_CHAIR
References: