louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00718094: Pilot Study of Green Tea Extract (Polyphenon E®)in Ulcerative Colitis
Official title: A Phase IIa Pilot Study to Determine the Safety of an Oral Dose of Green Tea Extract (Polyphenon E®) and Provide Preliminary Evidence to Support Its Efficacy in Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mild to Moderately Active Ulcerative Colitis
Keywords: Ulcerative colitis
EGCG
Green tea polyphenols
Inflammatory bowel disease
Colitis
IBD
Green tea
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2008-07-18
Enrollment: 20
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: Green tea consists of several components, with most research focusing on the polyphenol fraction. The polyphenol fraction(-)-epigallocatechin-3-gallate (EGCG)has been studied extensively as an anti-inflammatory agent as well as a preventative agent for cancer. It has been shown to effectively reduce the inflammation associated with animal models of inflammatory bowel disease. This clinical trial will determine the ability of EGCG, in the form of Polyphenon E®, to treat patients with mild to moderately severe ulcerative colitis.


Eligibility criteria: Inclusion Criteria:

* Adult male or female with mildly to moderately active ulcerative colitis

Exclusion Criteria:

* Off prohibited medications for proscribed period of time
* Evidence of infectious colitis
* Labs outside of range
* Pregnancy or lactation

Primary outcomes:
measure: Number of Subjects With a Reduction in the Disease Activity Index of >3, or Clinical Remission.
timeFrame: day 56
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville Clinical Research Center
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Gerald W Dryden, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dryden GW, Lam A, Beatty K, Qazzaz HH, McClain CJ. A pilot study to evaluate the safety and efficacy of an oral dose of (-)-epigallocatechin-3-gallate-rich polyphenon E in patients with mild to moderate ulcerative colitis. Inflamm Bowel Dis. 2013 Aug;19(9):1904-12. doi: 10.1097/MIB.0b013e31828f5198.
Clinical trial NCT03622294: A Clinical Analysis of Bella Blankets® Protective Coverlets
Official title: A Clinical Analysis of Bella Blankets® Protective Coverlets Used to Increase the Image Quality of Mammograms, Aid as a Quality Standard for EQUIP Clinical Image Quality (CIQ) Compliance Measurements and Improve Patient Satisfaction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Screening Mammogram
Lead sponsor: Beekley Medical
Sponsor class: INDUSTRY
Collaborators: name: Elizabeth Wende Breast Care, LLC
First posted: 2018-08-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will be female, asymptomatic patients randomly scheduled for a screening mammogram.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will collect and compare clinical image quality measurements of randomly scheduled, asymptomatic, screening mammography patients, right breast mammogram performed with and without the use of Bella Blankets protective coverlets on the receptor plate.

The measurements will determine if the use of Bella Blankets protective coverlets increases the mammogram's clinical image quality and if Bella Blankets protective coverlets can be used as an aid for EQUIP compliance.

In addition, a patient satisfaction survey will be conducted with participants to determine if the use of Bella Blankets protective coverlets improves patient satisfaction.


Eligibility criteria: Inclusion Criteria:

* Subject is Female of any race and ethnicity
* Subject is 40-75 years old
* Subject is scheduled for a screening mammogram
* Subject is willing and able to understand and read the Informed consent form
* Subject has been a patient at Elizabeth Wende Breast Care for 2 years or more

Exclusion Criteria:

* Subject is Male
* Subject has been a patient at Elizabeth Wende Breast Care for less than 2 years
* Subject has had a breast biopsy within the last 2 years
* Subject has had breast surgery within the last 2 years
* Subject is scheduled for a Diagnostic mammogram
* Subject suspects or may be pregnant
* Subject is currently pregnant or breastfeeding
* Subject has breast implants

Primary outcomes:
measure: Clinical Image Quality (CIQ) Outcomes of a Participant's Right Breast Mammogram Performed with Bella Blankets Protective Coverlets on the Receptor Plate to a Bare Receptor Plate.
timeFrame: Through the completion of 100 participants; approximately 4 months
Secondary outcomes:
measure: Patient Satisfaction Survey
timeFrame: Through the completion of 100 participants; approximately 4 months
Other outcomes:
measure: Assessment as an Aid to Achieve Standards for Mammogram EQUIP Compliance Measurements.
timeFrame: At the completion of 100 participants; approximately 4 months from study initiation
Locations:
city: Rochester
country: United States
facility: Elizabeth Wende Breast Care, LLC
state: New York
Study officials:
References:
Clinical trial NCT00582894: Reduced-Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Malignant Hematological Diseases
Official title: Reduced-Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Malignant Hematological Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematological Neoplasms
Hematopoietic Stem Cell Transplantation
Keywords: Allogenic stem cell transplant
Hematologic diseases
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2007-12-28
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate engraftment and toxicity of a reduced intensity preparative regimen for patients who receive a matched related or unrelated donor allogeneic stem cell transplant (ASCT) for malignant hematological diseases

Detailed description: Primary Endpoints:

1. Engraftment of donor cells
2. Regimen related toxicities

Secondary Endpoints:

1. Disease-free survival
2. Overall survival

Eligibility criteria: Inclusion Criteria:

* Performance status 0-2
* Ejection fraction \> 30%
* AST/ALT and bilirubin not \> 4 times normal
* Creatinine clearance greater than 70 ml/min.
* FEV1 greater than 1.0 and diffusion capacity greater than 40%
* Age 18-75 years
* Patients must be at high risk for conventional regimen related toxicity
* Malignant hematologic disease that would otherwise be considered treatable with ASCT

Exclusion Criteria:

* Does not meet the above Inclusion criteria

Primary outcomes:
measure: Number of Participants Experiencing Transplant Related Mortality (TRM)
timeFrame: At Day 100 post trans-plant
measure: Number of Participants Experiencing Engraftment Donor Chimerism (EDC)
timeFrame: At time of study termination
Secondary outcomes:
measure: Number of Participants Relapse-Free
timeFrame: 100 days post-transplant
measure: Number of Participants Overall Survival as a Function of Time.
timeFrame: 100 days post transplant
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: George Selby, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02671994: Geriatric and Oncologic Assessment Before Treatment
Official title: Significance of Geriatric Assessment for Optimal Treatment of Older Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Keywords: Geriatric Assessment
G8 screening
Oncologic treatment
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2016-02-02
Enrollment: 114
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In a randomized controlled trial, the investigators wish to investigate, if oncologic treatment decision based on G8 screening followed by geriatric assessment and subsequent MDT, if needed, in older frail patients with gynaecologic and urologic cancer is superior to standard assessment (PS and clinical assessment) in oncologic treatment decision.


Eligibility criteria: Inclusion Criteria:

* Histologically verified gynaecologic cancer (ovarian, uterine, or cervical cancer) or urologic cancer (prostate, bladder, or kidney cancer).
* Suited for first line medical oncologic treatment with chemotherapy and/or targeted therapy.
* Age ≥ 70 years.
* Understands, speaks, and writes Danish.
* Signed informed consent.

Exclusion Criteria:

* Previous cancer diagnosis except for carcinoma in situ of the cervix or skin cancer other than malignant melanoma.
* Previous chemotherapy and/or targeted therapy for current cancer diagnosis.
* Previous radiation therapy or concomitant radiotherapy for current cancer diagnosis.
* Surgery within the last 4 weeks.

Primary outcomes:
measure: Feasibility of planned oncologic treatment (number of participants, who complete the planned oncologic treatment)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Jørn Herrstedt, MD, DMSc
role: STUDY_DIRECTOR
References:
citation: Nadaraja S, Matzen LE, Jorgensen TL, Dysager L, Knudsen AO, Jeppesen SS, Moller S, Herrstedt J; Academy of Geriatric Cancer Research (AgeCare). The impact of comprehensive geriatric assessment for optimal treatment of older patients with cancer: A randomized parallel-group clinical trial. J Geriatr Oncol. 2020 Apr;11(3):488-495. doi: 10.1016/j.jgo.2019.06.019. Epub 2019 Jul 3.
Clinical trial NCT03094494: Double Carbapenem as Rescue Strategy for the Treatment of Carbapenemase-Producing Klebsiella Pneumoniae Infections
Official title: Double Carbapenem as Rescue Strategy for the Treatment of Severe Carbapenemase-Producing Klebsiella Pneumoniae Infections: A Two-Center Matched Case-Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carbapenem
Klebsiella Pneumonia
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2017-03-29
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients with severe CR-Kp infection

Brief summary: An observational two-center case-control study exploring the clinical impact of double-carbapenem use in a population of critically il patients with severe carbapenem-resistant Klebsiella pneumoniae infection


Eligibility criteria: Inclusion Criteria:

1. age ≥ 18 years;
2. ICU admission between November 2012 and December 2015;
3. documented CR-Kp invasive infection;
4. targeted antibiotic therapy lasting ≥ 72 hours

Exclusion Criteria

1. Klebsiella infection, susceptible to carbapenems
2. Duration of antimicrobial therapy less than 72 hours
3. Data not completely available from the electronically medical chart

Primary outcomes:
measure: 28-day mortality
timeFrame: 28 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: De Pascale G, Martucci G, Montini L, Panarello G, Cutuli SL, Di Carlo D, Di Gravio V, Di Stefano R, Capitanio G, Vallecoccia MS, Polidori P, Spanu T, Arcadipane A, Antonelli M. Double carbapenem as a rescue strategy for the treatment of severe carbapenemase-producing Klebsiella pneumoniae infections: a two-center, matched case-control study. Crit Care. 2017 Jul 5;21(1):173. doi: 10.1186/s13054-017-1769-z.
Clinical trial NCT03565094: Single Dose of Lu AF28996 to Healthy Young Men
Official title: Interventional, Open-label, Single- and Sequential-ascending-dose Study Investigating the Safety, Tolerability and Pharmacokinetic Profile of Lu AF28996 in Healthy Young Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2018-06-21
Enrollment: 39
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates how increasing doses of Lu AF28996 enters, moves through and exits the body when given by mouth to healthy young men.

Detailed description: Part A of the study consists of 6 groups (Cohorts 1 to 6) with 3 subjects in each, with the possibility of 4 additional cohorts. In cohort 1, the subjects will receive a single dose of Lu AF28996 by mouth. Following evaluation of data from the first dose, the subjects in the following cohorts are planned to receive two single increasing doses by mouth of Lu AF28996 on 2 separate days with a wash out (day or days without dosing) in between.

Part B is an open-label three-period crossover study in healthy young men to compare the PK of an oral capsule formulation with that of an oral solution formulation and to evaluate food effect following oral capsule administration of Lu AF28996.The subjects will be randomised to one of the four treatment sequences

Eligibility criteria: Inclusion Criterium:

Healthy, young, non-smoking men aged ≥18 and ≤45 years and with a body mass index (BMI) ≥18.5kg/m2 and ≤30kg/m2 at the Screening Visit

Other in- and exclusion criteria may apply

Primary outcomes:
measure: AUC 0-inf
timeFrame: From dosing to day 12 postdose
measure: Cmax
timeFrame: From dosing to day 12 postdose
measure: CL/F
timeFrame: From dosing to day 12 postdose
Secondary outcomes:
measure: Number of participants with Treatment-Emergent Adverse Events
timeFrame: From dosing to day 12 postdose
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: QPS Netherlands BV
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT05528094: An Exploratory Investigation of a Supplement to Support Student Learning
Official title: An Exploratory Investigation of a Supplement to Support Student Learning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Concentration Ability Impaired
Mental Fatigue
Lead sponsor: JoySpring
Sponsor class: OTHER
Collaborators: name: Citruslabs
First posted: 2022-09-06
Enrollment: 38
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In this trial, the herbal supplement (GeniusDrops) will be tested to see the effects it has on the dependent variables of interest. Participants will take the supplement twice a day for a month and respond to surveys at study baseline, midpoint, and the conclusion of the study. The findings of this study will be used for marketing materials and to inform future trials using the supplement.


Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed consent form and a parental assent form
* Must be experiencing issues with focus, mood, and memory
* Must be looking to improve classroom performance
* Gets easily distracted

Exclusion Criteria:

* Diagnosis of ADD or ADHD
* Currently taking a prescription medication meant to treat ADD or ADHD
* Diagnosed with additional conditions that would not allow them to adhere to the protocol.
* Willing to take a supplement targeting improving mood, concentration, and focus

Primary outcomes:
measure: Examination of self-reported focus
timeFrame: 4 weeks
measure: Examination of Self-reported concentration
timeFrame: 4 weeks
measure: Examination of Self-reported mood states
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
affiliation: Citruslabs
name: Christopher Hill
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00957294: Metabolic Syndrome in Patients With First-episode Schizophrenia
Official title: The Metabolic Syndrome in Patients With First-episode Schizophrenia - Prognosis and Prediction.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Syndrome X
Schizophrenia
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2009-08-12
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to The OPUS project, Region of Midtjylland, Denamrk In comparison in-patients with major depression, Aarhus University Hospital, Risskov and healthy controls matched on gender, age and level of education.

Brief summary: The metabolic syndrome (MetS) is highly prevalent in patients with schizophrenia and is a major risk factor of type-2 diabetes, cardiovascular disease and early death. Genetic factors, antipsychotic medication, sleeping disturbances and unhealthy lifestyle are possible causes of developing metabolic syndrome. Several studies have investigated the metabolic side-effects of antipsychotic medication. However it is still unanswered how unhealthy lifestyle, comprising physical inactivity, smoking, unhealthy dieting, and sleeping disturbances adds to the metabolic risk of patients with schizophrenia. The aim of this study is to investigate the prevalence and development of MetS in first-episode patients with schizophrenia and 1 year after onset of treatment. The study's main hypothesis is that physical inactivity, regardless of medication, is an independent risk factor for metabolic syndrome in patients with schizophrenia. In comparison inpatients with major depression and healthy controls, both matched on gender, age and level of education will be included in the study. It is anticipated that the study's results will provide new knowledge about the risk of developing metabolic syndrome in first-episode schizophrenia and how different risk factors contribute to this.


Eligibility criteria: Inclusion Criteria:

* Patients with ICD-10 diagnosed schizophrenia

Exclusion Criteria:

* Antipsychotic medication \> 6 weeks before inclusion
* Physical disability
* Pregnancy
* IQ\< 55

Primary outcomes:
measure: metabolic syndrome
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Research Unit, Dep. Q of Affective Disorders, Aarhus University Hospital, Risskov
state: Risskov
Study officials:
References:
Clinical trial NCT01973894: Midazolam Whole Body Physiologically Based Pharmacokinetic Model
Official title: Whole Body Physiologically Based Pharmacokinetic (PBPK) Model to Estimate Cerebral and Systemic Midazolam Concentrations in ICU Patients Under Sedation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Failure
Coma
Keywords: PBPK
Midazolam
Pharmacokinetics
Critically ill patients
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
Collaborators: name: University of Milan
First posted: 2013-11-01
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: Critically ill patients in Intensive Care Unit, mechanically ventilated, sedated with midazolam, intravenous continued perfusion.

Brief summary: This study investigates what independent variables may influence Midazolam Pharmacokinetics in critically ill patients.

Detailed description: This study has three specific aims:

1. to create a Midazolam PBPK model based on anthropometric and physiopathological data from enrolled patients;
2. to estimate cerebral and systemic Midazolam concentrations;
3. to assess independent variables about Midazolam pharmacokinetic in critically ill patients.

Eligibility criteria: Inclusion Criteria:

* ICU admittance
* Caucasian
* Clinical indication of least 72h of continuous sedation with Midazolam
* MAP between 60 - 150 mmHg, even if obtained with amine support
* informed consent obtained

Exclusion Criteria:

* Any endocranial lesion, spontaneous or induced
* PaCO2 \> 60 mmHg or \< 30 mmHg
* PaO2 \< 50 mmHg
* Pregnancy
* Anuria
* Any transplantation
* Severe hepatic failure (Child C)
* Life expectancy \< 72h
* Ketoconazole and antiretrovirals in therapy

Primary outcomes:
measure: Midazolam concentration in serum and urine
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Secondary outcomes:
measure: Fat mass analysis and its importance in drug distribution.
timeFrame: At enrollment
Other outcomes:
Locations:
city: Varese
country: Italy
facility: Azienda Ospedaliera Ospedale di Circolo e Fondazione Macchi
Study officials:
affiliation: Università degli Studi dell'Insubria, Varese, Italy
name: Paolo Severgnini, Prof.
role: PRINCIPAL_INVESTIGATOR
References: