louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01561300: Efficacy of Brooke Bond Black Tea Extract on Flow Mediated Dilation in Indian Males
Official title: Efficacy of Standardized Brooke Bond Black Tea Extract on Flow-Mediated Dilation After an Acute Dose as Well as After One Week of Consumption in Healthy Adult Indian Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Black tea
Flow Mediated Dilation
Vascular function
India
Lead sponsor: Unilever R&D
Sponsor class: INDUSTRY
Collaborators: name: Lotus Labs Pvt. Ltd, Bangalore, India
name: Clumax Diagnostics, Bangalore, India
name: Quipu S.r.l, Pisa, Italy
First posted: 2012-03-23
Enrollment: 30
Sex: MALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study examines the effect of 1800 mg/day standardized Brooke Bond black tea extract, equivalent to 400 mg flavonoids, on Flow Mediated Dilation in healthy Indian males.

Detailed description: Flow mediated dilation (FMD) is a non-invasive measurement technique performed using ultrasound equipment to measure hyperaemia induced dilation of blood vessels. Evidence from prospective studies suggests that FMD is independently inversely associated with cardiovascular events.

Eligibility criteria: Inclusion Criteria:

* Male volunteers aged between \>_30 _\< 50 years of age
* Body Mass Index (BMI) of \>_18 and _\< 25.0 kg/m2
* Systolic blood pressure \>_140 and \>_100 mmHg and diastolic blood pressure \< 90 and \> 70 mmHg
* Subjects who consume _\< 2 cups of coffee per day
* Subjects who drink tea regularly (\>_ 2 cups per day)
* Apparently healthy, with no reported medical condition which might affect the assessment as judged by the study physician or/and PI
* No prescribed medical treatment that may affect study parameters as judged by the Study Physician
* Subject willing to abstain from alcohol on day before and on the day of assessment
* Willing to sign the informed consent form

Exclusion Criteria:

* Smokers and/or tobacco chewers
* Those who consume regular alcohol (\> 160 ml of alcohol per week)
* Reported intense sport activities \> 10h/week
* Participating in any other clinical study concurrently or if participated in any study during 2 months preceding the screening visit

Primary outcomes:
measure: 'Acute-upon-chronic Effect' of Tea vs Control
timeFrame: Baseline day 1 to 2 hours post consumption on day 8.
Secondary outcomes:
measure: Acute Effect of Tea vs Control
timeFrame: From baseline on day 1 to 2 hours post consumption on day 1
measure: Chronic Effect of Tea vs Control
timeFrame: From baseline at day 1 to baseline on day 8
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Lotus Labs Pvt. Ltd.,
state: Karnataka
Study officials:
affiliation: Unilever Industries Pvt. Ltd
name: Anisha Pargal, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT05675800: Psilocybin for Major Depressive Disorder
Official title: Psilocybin for the Treatment of Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Major Depressive Disorder
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-01-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to assess the effectiveness of psilocybin for the treatment of Major Depressive Disorder and potential therapeutic mechanisms. Enrolled participants will receive a single active dose of psilocybin, or a dose considered high enough to treat depression, administered orally with accompanying psychological support.


Eligibility criteria: Inclusion Criteria:

* Currently meeting DSM-V Criteria for a Major Depressive Episode of at least mild-moderate severity
* Aged 18-85
* Ability and willingness to attend study visits and complete study assessments

Exclusion Criteria:

* Presence of medical conditions at screening that may affect the safe administration of psilocybin (including, but not limited to: AST/ALT \> 150, QTc \> 450ms, MELD \> 9)
* Depression deemed secondary to a severe medical condition
* Recent use of any classical psychedelic drug or MDMA
* Recent use of any interventional psychiatric treatment (including: ECT, ketamine, esketamine, TMS)
* Intention to begin any new treatment for depression prior to primary outcome determination
* Use of any excluded medication
* Active substance use disorder
* Presence of any psychiatric condition that may interfere with the safe administration of psilocybin
* Active suicidal ideation

Primary outcomes:
measure: MADRS (Montgomery-Asberg Depression Rating Scale) Change from Baseline
timeFrame: 3 weeks post-treatment
measure: Adverse Events
timeFrame: Up to 12 weeks post-treatment
measure: Study Retention and Completion
timeFrame: Throughout study participation (12-17 weeks)
Secondary outcomes:
measure: MADRS (Montgomery-Asberg Depression Rating Scale) Change from Baseline
timeFrame: 12 weeks post-treatment
Other outcomes:
Locations:
Study officials:
affiliation: Washington University School of Medicine
name: Ginger Nicol, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00923000: Herb Drug Interaction of Traditional Chinese Herb and Commonly Used Drugs
Official title: Herb Drug Interaction of Traditional Chinese Herb and Commonly Used Drugs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Keywords: Herb Drug
volunteers
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2009-06-18
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study was to investigate a possible response to nalbuphine (Nubian) and morphine with traditional Chinese herbs in healthy volunteers.

Detailed description: This study is a single center and open-label design to investigate the pharmacokinetic properties of Nubian, Nubian traditional Chinese herb combination dosage after single oral with oral administration, or morphine, morphine traditional Chinese herb combination dosage after single oral administration in healthy volunteers under fasting conditions.

Eligibility criteria: Inclusion Criteria:

* Normal healthy adult subjects between 20-40 years of age
* Body weight within 80-120% of ideal body weight
* Acceptable medical history, physical examination and clinical laboratory determinations

Exclusion Criteria:

* Recent history of drug or alcohol addiction or abuse
* Donating greater than 150 ml of blood within two months prior to Period I
* Taking any prescription medication or any nonprescription medication within 14 days prior to Period I doing
* Receiving any investigational drug within 30 days prior to Period I dosing
* Taking any drug known to induce or inhibit hepatic drug metabolism within 30 days prior to the beginning of the study
* Any clinically significant diseases
* History of allergic response to nalbuphine or related drugs and traditional Chinese herbs

Primary outcomes:
measure: The pharmacokinetic parameters
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
Study officials:
affiliation: Tri-Service General Hospital
name: Hung-Tai Ho
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03516500: Trial of Identifying the Lung Intersegmental Plane by Iron Sucrose Injection Staining
Official title: This is a Phase II Study on the Safety and Feasibility of Identifying the Intersegmental Plane of the Lung by Iron Sucrose Injection Staining,Both on the Pleural Surface and Lung Parenchyma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Neoplasm
Segmentectomy;Intersegmental Plane
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2018-05-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: After the investigators cut the pulmonary vessels and ligate the segmental bronchus. The investigators inject Iron Sucrose (100 mg dissolved in 50 mL saline) through a butterfly needle into the bronchus of the targeting segment.
Primary purpose: TREATMENT

Brief summary: This is a protocol to determine the safety and feasibility of using Iron Sucrose Injection to identify the intersegmental plane,not only on the pleural surface but also the parenchyma of the lung.

Detailed description: This is a protocol to determine the safety and feasibility of using Iron Sucrose Injection to identify the lung intersegmental plane. This is relevant because the detection of small and early lung cancer is becoming increasingly common. segmentectomy may become a more prominent procedure for early-small lung cancer. One of the most difficult aspects of complete segmentectomy is detection of the intersegmental plane while maintaining an adequate surgical margin and remaining lung function. The method used to detect the intersegmental plane remains controversial. It is hoped that this technology can be used to recognize the intersegmental plane on the pleural surface and the pulmonary parenchyma and will save lots of money for patients in developing countries.

Eligibility criteria: Inclusion Criteria:

* 18 years ≤age ≤80 years
* The patient must be scheduled to undergo segmentectomy or combined subsegmentectomy.
* The patient must be willing and able to comply with all study requirements and have understood and signed the informed consent.

Exclusion Criteria:

* A known allergy to Iron Sucrose Injection
* The patients who have Iron overdose or iron utilization barrier Intra-operative founding of extensive pigmentation Silicosis or extensive carbon deposition in the lung.
* Patients who have not received segmental resection.
* Patients who converted to thoracotomy.

Primary outcomes:
measure: Incidence of treatment-related grade 3-5 adverse events
timeFrame: Up to 90 days post-surgery
Secondary outcomes:
measure: Surgical margin
timeFrame: Day of surgery
Other outcomes:
measure: duration of air leaks
timeFrame: 30 days after the patient was discharged.
measure: Hospital Costs
timeFrame: 30 days after the patient was discharged
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai JiaoTong University School of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT01350700: Long Term Follow up of Scars Formation and Quality of Life Assessment Study
Official title: Scar Formation and Quality of Life Assessment in Subjects (Adults & Children) Following Treatment With Debrase Compared to Standard of Care (SOC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scars Formation
Quality of Life
Keywords: QOL
Lead sponsor: MediWound Ltd
Sponsor class: INDUSTRY
First posted: 2011-05-10
Enrollment: 148
Sex: ALL
Minimum age (years): 4
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that have previously participated in MW2004-011-02 study

Brief summary: In previous study (MW2004-011-02), patients with burn wounds had their damaged skin removed by either standard of care treatment or by Debrase Gel Dressing (DGD), which is composed of enzymes that dissolve the damaged skin selectively (DGD removes only the damaged skin and not other parts of the skin).

The burn wound, like any other wound, heals by the formation of scar at the injured site in order to replace the destroyed tissues. Scarring is not a static process, but rather a dynamic one, changing over time, especially during the first 24 months post-injury.

Scars and patients' quality of life from two treatment arms (DGD and SOC) will be compared in order to evaluate the long term influence of damaged skin removal and wound care techniques on scar formation and maturation.


Eligibility criteria: Inclusion criteria

1. Adults and children who had participated and completed study MW2004-11-02.
2. Subjects must be willing and able to sign a written informed consent prior to study entry (by subject or by a guardian, when applicable).

Primary outcomes:
measure: 1. Scar assessment of target wounds that have been treated by Debrase or SOC during MW2004-11-02 using Modified Vancouver Scar Scale (MVSS)
timeFrame: Approximately 2 years after wound closure
measure: 2. To evaluate and compare the Quality of Life (QoL) in adult and children that their burn wounds were treated with Debrase or SOC in study MW2004-11-02
timeFrame: Approximately 2 years after wound closure
Secondary outcomes:
Other outcomes:
Locations:
city: Kosice
country: Slovakia
facility: Clinic of Burns and reconstructive surgery hospital
Study officials:
affiliation: Department Head of Burs and Reconstructive Surgery
name: Jan Koller, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01691300: C11-Acetate PET/CT in Multiple Myeloma: Added Value to F18-Fluorodeoxyglucose PET/CT
Official title: C11-Acetate PET/CT in Multiple Myeloma: Added Value to F18-Fluorodeoxyglucose PET/CT for Staging and Response Assessment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Myeloma
Keywords: C11-acetate PET/CT
Multiple myeloma
Pretreatment staging
Response assessment
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2012-09-24
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Positron emission tomography combined with computed tomography using carbon-11 acetate (ACT PET/CT) may help detect lesions before treatment and evaluate response following therapy in patients with from multiple myeloma (MM). This study aimed to prospectively assess the clinical utility of ACT PET/CT in MM as compared to the commonly used F18-fluorodeoxyglucose(FDG).


Eligibility criteria: Inclusion Criteria:

* at least 20 years of age
* previously untreated
* complete pre-treatment clinical staging including bone marrow examination
* written informed consent to participate in the study

Exclusion Criteria:

* concurrent active malignant tumor(s)
* pregnant or breast feeding women
* non-compliant to PET/CT or to MRI
* marked renal impairment (contraindicated for contrast-enhanced MRI)

Primary outcomes:
measure: Pretreatment lesion detection
timeFrame: Within 2 weeks before initiation of therapy
Secondary outcomes:
measure: Post-induction response assessment
timeFrame: Approximately 4 months after initiation of therapy depending on the regimen
measure: Post-ASCT response assessment
timeFrame: Approximately 3 months after ASCT
Other outcomes:
measure: Progression free survival
timeFrame: With 2 years of follow-up time
Locations:
city: Gueishan
country: Taiwan
facility: Chang Gung Memorial Hostpial
state: Taoyuan county
Study officials:
affiliation: Department of Molecular Imaging Center and Nuclear Medicine, Chang Gung Memorial Hospital
name: Chieh Lin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04768400: MEP and Neuromuscular Blocker
Official title: Quantitative Analysis Between Neuromuscular Blocking Agent and Motor Evoked Potential and Analysis of Risk Factors for the Coefficient of Variance of Motor Evoked Potential in Patients Undergoing Brain Tumor Removal Surgery: Population Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Tumor
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2021-02-24
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: It is important to predict the influence of the neuromuscular blocking agents on the motor evoked potential. Investigator will investigate the dose-response relationship between the degree of the neuromuscular blockade and the motor evoked potential in patients undergoing brain tumor surgery using the population approach. Investigator will investigate the influence of the other factors such as the impedence, reactance, muscel amount, and age on the motor evoked potential.


Eligibility criteria: Inclusion Criteria:

1. Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3, and scheduled for elective brain tumor surgery under the monitoring of the motor evoked potential

Exclusion Criteria:

1. Central or peripheral neuromuscular disease
2. Sensory or motor nerve disorder
3. Allergy to propofol, remifentanil, and rocuronium
4. Patients with pacemaker

Primary outcomes:
measure: Amplitude of the motor evoked potential
timeFrame: At intraoperative 0 hr from the start of the anesthetic induction
Secondary outcomes:
measure: Amplitude of the motor evoked potential
timeFrame: At intraoperative 0 h from the opening of the dura
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GangnamSeverance Hospital
Study officials:
References:
Clinical trial NCT02796300: Study to Compare Palindrome vs. BioFlo DuraMax Dialysis Catheters
Official title: Comparison of the Palindrome vs. BioFlo DuraMax Hemodialysis Catheters: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: bioflo
Duramax catheter
dialysis
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Angiodynamics, Inc.
First posted: 2016-06-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Numerous catheter designs have been studied to increase efficacy and minimize complications of catheter hemodialysis. Major complications of catheters include thrombosis, central venous stenosis, infection, and dialysis inadequacy. Thrombosis must be avoided if possible because using too many catheters may exhaust all of the catheter insertion sites on the body, as well as increase the risk of infection. This prospective study compares the complications and general outcomes of patients who receive hemodialysis using the mainstream Palindrome catheter versus the newer BioFlo DuraMax catheter.

This study will examine outcomes of patients who receive hemodialysis using either the Palindrome catheter or the BioFlo catheter. Patients will be observed and outcomes will be recorded for three to six months. Outcomes will be analyzed and compared to draw conclusions on which catheter produces less catheter thrombosis.


Eligibility criteria: Inclusion Criteria:

1. Males and females 18 - 65 years of age;
2. First de novo dialysis catheter placement or second catheter exchange, no more than 3 replacements on a same site
3. Requiring at least 3 months dialysis catheter usage
4. No clinical or radiographic evidence of superior vena cava (SVC) narrowing
5. Patent right internal or external jugular vein
6. Willing to provide the dialysis center information for F/U
7. No known diagnosis of hypercoagulopathy

Exclusion Criteria:

1. Short term catheter usage plan (\< 1 months)
2. No right jugular venous access
3. Catheter use for bone marrow transplant or plasmapheresis

Primary outcomes:
measure: Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters.
timeFrame: 1 month
Secondary outcomes:
measure: Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters.
timeFrame: 3 months
measure: Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters.
timeFrame: 6 months
measure: Cost Analysis
timeFrame: 3 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Edward Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02401100: Anastomotic Leakage After Anterior Resection for Rectal Cancer - Predictive Biomarkers and Rectal Blood Flow
Official title: Anastomotic Leakage After Anterior Resection for Rectal Cancer - Predictive Biomarkers and Rectal Blood Flow
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anastomotic Leak
Keywords: Rectal Neoplasms
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2015-03-27
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with rectal cancer who undergo anterior resection for rectal cancer at Umeå University Hospital.

Brief summary: The purpose of this study is to determine whether reduced rectal blood flow is associated with the extent of surgery when performing an operation to remove rectal cancer. The investigators also aim to describe any relation of reduced rectal blood flow, as well as raised inflammatory biomarkers in blood and tissue, to the occurrence of anastomotic leakage. The patients will be recruited at Umeå University Hospital and all patients who are planned to undergo anterior resection for rectal cancer and able to consent are eligible for this study. Rectal blood flow measurements will be conducted with Laser-Doppler technology using noninvasive measuring probes. Preoperative and postoperative blood sampling as well as postoperative drain fluid collection will take place. Perianastomotic tissue will also be collected. In the postoperative period, any occurrence of surgical complications especially anastomotic leakage, will be noted. Blood flow and biomarkers will be assessed in relation to type of mesorectal excision (total or partial) and correlated to anastomotic leakage. Standard statistical tools will be utilized, such as parametric, non-parametric tests and logistic regression, as appropriate. The study will recruit approximately 40 patients during three consecutive years.


Eligibility criteria: Inclusion Criteria:

* Planned anterior resection for rectal cancer
* Willing to participate

Exclusion Criteria:

* Not willing to participate
* Unable to consent

Primary outcomes:
measure: Blood flow measurements
timeFrame: Start and end of operation
Secondary outcomes:
measure: Anastomotic leakage
timeFrame: 90 days postoperatively
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Umeå University Hospital
Study officials:
affiliation: Umeå University
name: Martin Rutegård, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Back E, Brannstrom F, Svensson J, Rutegard J, Matthiessen P, Haapamaki MM, Rutegard M. Mucosal blood flow in the remaining rectal stump is more affected by total than partial mesorectal excision in patients undergoing anterior resection: a key to understanding differing rates of anastomotic leakage? Langenbecks Arch Surg. 2021 Sep;406(6):1971-1977. doi: 10.1007/s00423-021-02182-0. Epub 2021 May 18.