louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03461068: Exogenous Ketones and Glucose Tolerance
Official title: The Effect of Exogenous Ketone Monoester Supplement on Glycemic Response to an Oral Glucose Tolerance Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ketones
Dietary Supplements
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2018-03-09
Enrollment: 15
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The ketone body beta-hydroxybutyrate is produced during prolonged fasting or when endogenous carbohydrate stores are depleted and can be used as an alternative fuel source. Exogenous beta-hydroxybutyrate, in the form of a ketone monoester, is proposed to have glucose-lowering potential but this has not been adequately studied. The purpose of this study is to determine whether supplementing with an acute dose of ketone monoester can improve the glycemic response to an oral glucose tolerance test in individuals with impaired fasting glucose.


Eligibility criteria: Inclusion Criteria:

* Not taking any medications affecting glucose metabolism.
* Elevated fasting glucose level (5.6-6.9 mmol/L) OR body mass index \>28 kg/m2 OR elevated waist circumference (\>102 cm for males, \>88 cm for females)

Exclusion Criteria:

* Diagnosed with diabetes.
* Diagnosed with heart disease.
* Competitive endurance athlete (self-identified as engaged in specific endurance training in triathlon, cycling, or distance running and competing in races or competition)
* Recent (last 3 months) or current consumption of a low-carbohydrate ketogenic diet
* Current consumption of ketone supplements
* Pregnant or planning to become pregnant during the study (if female)

Primary outcomes:
measure: Glucose area under the curve
timeFrame: 2-hour
Secondary outcomes:
measure: Insulin area under the curve
timeFrame: 2-hour
measure: Free fatty acids area under the curve
timeFrame: 2-hour
measure: Caspase-1 activation
timeFrame: 15 minutes
measure: Inflammatory cytokines
timeFrame: 15 minutes
measure: C-peptide area under the curve
timeFrame: 2-hour
measure: GLP-1 area under the curve
timeFrame: 2-hour
measure: Glucagon area under the curve
timeFrame: 2-hour
measure: Glucose incremental area under the curve
timeFrame: 2-hour
measure: Insulin incremental area under the curve
timeFrame: 2-hour
measure: 2-hr glucose level
timeFrame: 2-hour
measure: Oral glucose sensitivity index
timeFrame: 2-hour
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia, Okanagan.
state: British Columbia
Study officials:
References:
citation: Myette-Cote E, Caldwell HG, Ainslie PN, Clarke K, Little JP. A ketone monoester drink reduces the glycemic response to an oral glucose challenge in individuals with obesity: a randomized trial. Am J Clin Nutr. 2019 Dec 1;110(6):1491-1501. doi: 10.1093/ajcn/nqz232.
Clinical trial NCT01488968: Conventional Versus Hypofractionated Radiation in High Risk Prostate Patients
Official title: A Phase II Randomized Control Trial of Conventional Versus Hypofractionated Radiation Regimen in Single Phase Using IMRT Technique and Long Term Androgen Suppression Therapy in High-risk Prostate Cancer Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: High-risk Prostate Cancer
Keywords: high risk prostate cancer
hypofractionated radiation treatment
higher biological doses
acceptable rectal toxicity
Radiation Treatment
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2011-12-09
Enrollment: 134
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hypofractionated regimen in high-risk prostate cancer will allow the investigators to deliver higher biological doses to targets in order to improve tumor control and with acceptable rectal toxicity compared to conventional fractionation.


Eligibility criteria: Inclusion Criteria:

* Patient is 18 years of age or older
* Patient has histologically proven adenocarcinoma of prostate gland by needle core samples or TURP with assigned Gleason score. Prostate biopsy performed within 180 days of enrollment (date of consent).
* Patient has high-risk prostate cancer (stage T3 or T4) and/or PSA greater than or equal to 20 ng/ml and/or Gleason score 8 to 10
* No clinical or radiological evidence of nodal or distant metastasis(es).
* In the opinion of the treating oncologist, patient is fit to undergo radical external beam radiotherapy to the prostate. Patients are accessible for treatment and follow up.
* Patient does not have history of inflammatory bowel disease, anal stenosis, colorectal surgery, or repeated endoscopic examinations/interventions related to anorectal diseases.
* No history of prostatectomy, transurethral resection of prostate on more than one occasion or previous pelvic radiotherapy.
* No history of androgen suppression for greater than or equal to 6 months and patient is willing for androgen suppression treatment as per standard or at physician's discretion.
* No previous malignancy within last five years except BCC or SCC skin or highly curable malignancy where a prognosis for cure is \> 80%.
* Patient signed informed consent.

Primary outcomes:
measure: The rate of late rectal toxicities between hypofractionated versus conventional fractionated schedules in high risk prostate cancer patients
timeFrame: 5 years
Secondary outcomes:
measure: The biochemical control (freedom from PSA failure) rate
timeFrame: 10 years
measure: Disease free survival
timeFrame: 10 years
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: Cross Cancer Institute
name: Albert Murtha
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01981668: The JET Study: a Phase I Trial of Cabazitaxel, Radiotherapy and Long-term Androgen Deprivation
Official title: The JET Study: a Phase I Trial of Cabazitaxel, Radiotherapy and Long-term Androgen Deprivation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Prostatic Neoplasms
Lead sponsor: Nova Scotia Cancer Centre
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2013-11-11
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study utilizes a conventional phase I study design with a '3+3 cohort expansion' design(15), to determine the maximum tolerated dose(MTD) of 1) Cabazitaxel, in Part A, and 2) Radiotherapy, in Part B. The determination of the MTD is given in Section 5.2, Definition of Dose - Limiting Toxicity. All patients who enter the study, and begin concurrent chemo-radiation are analyzable for the primary endpoint of the study.

Detailed description: This study utilizes a conventional phase I study design with a '3+3 cohort expansion' design(15), to determine the maximum tolerated dose(MTD) of 1) Cabazitaxel, in Part A, and 2) Radiotherapy, in Part B. The determination of the MTD is given in Section 5.2, Definition of Dose - Limiting Toxicity. All patients who enter the study, and begin concurrent chemo-radiation are analyzable for the primary endpoint of the study.

Assuming that dose-limiting toxicity is not encountered, and both the maximum dose of Cabazitaxel is reached, in Part A of the study, and the maximum dose of Radiotherapy is reached in Part B of the study, the maximum number of patients required is as follows: Clinical Study Protocol - The JET study Date: September 11, 2012 Part A: 3 patients per level x 5 levels, plus 3 patients (for a total of 6) at the highest dose level of Cabazitaxel = 15 + 3 = 18 Part B: 3 patients per level x 3 levels, plus 3 patients (for a total of 6) at the highest dose level of Radiotherapy = 9 + 3 = 12 The total number of patients required is 30. Patients that do not complete concurrent chemotherapy, radiotherapy, and androgen deprivation therapy, for reasons other than DLT will be replaced.

Given our experience in chemo-radiation studies in a similar patient population, our Centre is anticipated to accrue 3 patients per month.

Eligibility criteria: Inclusion Criteria:

* High risk prostate cancer

Exclusion Criteria:

* mets

Primary outcomes:
measure: Toxicity
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: department of radiation oncology
name: Derek R Wilke, MD,MSc,FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05001568: Validation of a New Optimized Nighttime Providence Brace for Personalized Treatment of Adolescent Idiopathic Scoliosis
Official title: Validation of a New Optimized Nighttime Providence Brace for Personalized Treatment of Adolescent Idiopathic Scoliosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Scoliosis
Idiopathic Scoliosis
Keywords: Scoliosis
Spine deformity
Nighttime brace
Optimization
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 58
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be separated into two stages. Each patient will initially try a control brace and a test brace in a crossover study model to evaluate the immediate correction. Each patient will then use one brace from either the control arm or test arm to evaluate the long-term correction of the brace.
Primary purpose: TREATMENT

Brief summary: Adolescent Idiopathic Scoliosis affects 3-4% of the Canadian population, of which about 10% will need a brace treatment during pubertal growth spurt. Our team has developed an innovative conception method for brace design by optimizing for the immediate in-brace correction. The model is customized to each patient. In this project, the investigators will evaluate the effectiveness of this platform's customized treatment and validate its clinical application.


Eligibility criteria: Inclusion Criteria:

* AIS diagnosis
* Risser 0-2
* Primary curve angles 20 degrees - 40 degrees
* If female, either premenarchal or less than 18 months postmenarchal.

Exclusion Criteria:

* Patients with a pre-existing cardiovascular condition
* Patients with a symptom of a neurological disorder
* Patients with any other disorder of the musculoskeletal system affecting the lower limbs
* Pregnancy

Primary outcomes:
measure: Change in Cobb angle
timeFrame: Baseline, 1 year, 2 years
Secondary outcomes:
measure: Treatment failure rate
timeFrame: Baseline, 1 year, 2 years
measure: Quality of Life (QoL) - SRS-22r
timeFrame: Baseline, 1 year, 2 years
measure: Quality of Life (QoL) - MOBI
timeFrame: 1 year, 2 years
measure: Immediate in-brace Cobb angle
timeFrame: 5 minutes after brace fitting
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
Study officials:
References:
Clinical trial NCT02593968: Yallaferon in Chinese Population
Official title: a Multi-sites, Randomized, Parallel, Placebo-Controlled Clinical, Pilot Study to Evaluated the Efficacy and Safety of Recombinant Human Interferon Alpha-2b Gel (Yallaferon®) in HPV Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: HPV Infection
Lead sponsor: Lee's Pharmaceutical Limited
Sponsor class: INDUSTRY
First posted: 2015-11-01
Enrollment: 100
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of Yallaferon in Chinese population with HPV-16 and/or HPV-18.


Eligibility criteria: Inclusion Criteria:

* Age 25 to 65 years of age the sex life of female patients;
* High-risk HPV 16 and/or 18 positive
* Agree to sign ICF

Exclusion Criteria:

* Cervical intraepithelial neoplasia (CIN);
* Combined with a severe fungal, trichomonas vaginitis;
* Severe primary diseases associated with cardiovascular, liver, kidney and hematopoietic system;
* Allergies or allergy to the drug known ingredients.
* Within 30 days to accept other clinical trials of drugs or are participating in clinical trials;
* Pregnant and lactating women and to be pregnant women;
* The researchers do not consider it appropriate clinical trials.

Primary outcomes:
measure: HPV-16 and/or HPV-18 negative conversion rate
timeFrame: 3 months
Secondary outcomes:
measure: HPV-16 and/or HPV-18 negative conversion rate
timeFrame: 6 months
measure: HPV-16 and/or HPV-18 negative conversion rate
timeFrame: 9 months
measure: HPV-16 and/or HPV-18 negative conversion rate
timeFrame: 12 months
measure: reinfection at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
Study officials:
References:
Clinical trial NCT00880672: Effect of Dutasteride on HIF-1alpha and VEGF in the Prostate
Official title: Apoptosis and Expression of Neovascularization-related Factors in Human Prostate Tissue After Administration of Dutasteride
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Benign Prostatic Hyperplasia
Keywords: prostate, dutasteride
vascular endothelial growth factor
hypoxia inducible factor
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: The Korean Urological Association
name: GlaxoSmithKline
First posted: 2009-04-14
Enrollment: 40
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether dutasteride may influence the expression of angiogenesis factors such as hypoxia inducible factor (HIF)-1alpha and vascular endothelial growth factor (VEGF) in patients with lower urinary tract symptoms/benign prostatic hyperplasia (LUTS/BPH).

Detailed description: A total of 41 patients awaiting transurethral resection of the prostate (TURP) will be divided into two groups (1:1); twenty patients will receive no medication and 21 will receive 0.5 mg dutasteride daily for 2 to 4 weeks until TURP. In both groups, the extent, intensity and intracellular location of hypoxia inducible factor (HIF)-1alpha and vascular endothelial growth factor (VEGF)will be evaluated. Microvessel density will be also compared in the two groups.

Eligibility criteria: Inclusion Criteria:

* informed consent
* 50 years old or older
* International Prostate Symptom Score (IPSS) \>8
* Maximum flow rate (Qmax) \<15 ml/s
* transurethral resection of the prostate (TURP)

Exclusion Criteria:

* urethral catheter
* urinary tract infection (UTI)
* liver disease
* renal disease
* unexplained hematuria
* prostate specific antigen (PSA) \> 4ng/ml (included if prostate biopsy was negative)
* interstitial cystitis
* bladder cancer or prostate cancer
* pelvic surgery or irradiation

Primary outcomes:
measure: HIF-1a and VEGF expression
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Dept. of Urology, Seoul National University Hospital
name: Jae-Seung paick, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00818272: Remicade Safety Line (Crohn's Disease)(Study P03288)(COMPLETED)
Official title: Remicade Safety Line (Crohn's Disease)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Centocor, Inc.
First posted: 2009-01-07
Enrollment: 148
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: Subjects with Crohn's disease.

Brief summary: This observational study is in line with the German educational plan with the aim to implement a tool to increase and monitor the awareness for tuberculosis screening and to reinforce the patient eligibility for a treatment with Remicade according to the Summary of Product Characteristics (SmPc).


Eligibility criteria: Inclusion Criteria:

* Subjects with Crohn's disease.

Exclusion Criteria:

* As per SmPC

Primary outcomes:
measure: Number of Participants Who Had the Mendel Mantoux Test as the First Screening Test for Active or Latent Tuberculosis (TB) Before Starting Treatment
timeFrame: Baseline
measure: Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment
timeFrame: Baseline
measure: Number of Participants Who Had the In-vitro TB Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment
timeFrame: Baseline
measure: Number of Participants Who Had a Chest X-ray as Part of TB Screening for Active or Latent Tuberculosis Before Starting Treatment
timeFrame: Baseline
Secondary outcomes:
measure: Assessment of Disease Activity by Means of the Crohn's Disease Activity Index (CDAI) at the Time of Enrollment and at the First Infusion
timeFrame: Baseline and time of first Infusion
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03155672: A PHASE I, SINGLE-CENTER, MIXED METHODS STUDY ON THE HEALTH OUTCOMES OF VISUAL SELF EXPRESSION
Official title: A PHASE I, SINGLE-CENTER, MIXED METHODS STUDY ON THE HEALTH OUTCOMES OF VISUAL SELF EXPRESSION
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: A Healthcare Professional, a Patient or Caregiver in the Radiation Oncology Department at the University of Pennsylvania
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2017-05-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A healthcare professional, a patient or caregiver in the Radiation Oncology Department at the University of Pennsylvania

Brief summary: To gain understanding about the impact of visual art making on biomarkers, such as cortisol, alpha amylase, oxytocin, etc. to examine whether and to what extent there are changes in levels of stress and immune function in patients and caregivers adults (including family caregivers and medical professionals)


Eligibility criteria: Inclusion Criteria:

* Adults between the age of 18 - 70
* A healthcare professional, a patient or caregiver in the Radiation Oncology Department at the University of Pennsylvania
* Subjects must be capable of giving informed consent

Exclusion Criteria:

* Any healthcare professional or patient/caregiver not working in or being seen at Radiation Oncology Department at the University of Pennsylvania

Primary outcomes:
measure: NUmber of changes in levels of stress and immune function in patients and caregivers
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: William Levin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01863472: Catheter Ablation of Drug-refractory Persistent Atrial Fibrillation With the HeartLight(TM) Laser Balloon in Comparison With Irrigated Radiofrequency Current Ablation
Official title: Catheter Ablation of Drug-refractory Persistent Atrial Fibrillation With the HeartLight(TM) Laser Balloon in Comparison With Irrigated Radiofrequency Current Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Atrial Fibrillation
Lead sponsor: Cardioangiologisches Centrum Bethanien
Sponsor class: OTHER
First posted: 2013-05-29
Enrollment: 152
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: TREATMENT

Brief summary: Aim of the study is to compare the safety and efficacy of pulmonary vein isolation using the endoscopic ablation system in comparison to irrigated radiofrequency current ablation in patients with drug-refractory persistent atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

* 18 to 80 years
* persistent atrial fibrillation
* failure of at least one antiarrhythmic drug
* others

Exclusion Criteria:

* contraindications for pulmonary vein isolation (PVI)
* previous PVI attempts
* inability to be treated with oral anticoagulation
* presence of intracardiac thrombi
* pregnancy
* others

Primary outcomes:
measure: Documented recurrence of atrial fibrillation or any atrial tachyarrhythmia >30 seconds
timeFrame: between day 90 and 365 days after index procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: Na Homolce Hospital
city: Bad Neustadt
country: Germany
facility: Herz- und Gefäß-Klinik GmbH Bad Neustadt
state: Bavaria
city: Bonn
country: Germany
facility: Rheinische Friedrich-Wilhelms-Universität Bonn
state: NRW
city: Frankfurt/Main
country: Germany
facility: Cardioangiologisches Centrum Bethanien
city: Karlsruhe
country: Germany
facility: Städtisches Klinikum Karlsruhe, Medizinische Klinik IV
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
Study officials:
affiliation: Cardioangiologisches Centrum Bethanien
name: Boris Schmidt, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schmidt B, Neuzil P, Luik A, Osca Asensi J, Schrickel JW, Deneke T, Bordignon S, Petru J, Merkel M, Sediva L, Klostermann A, Perrotta L, Cano O, Chun KRJ. Laser Balloon or Wide-Area Circumferential Irrigated Radiofrequency Ablation for Persistent Atrial Fibrillation: A Multicenter Prospective Randomized Study. Circ Arrhythm Electrophysiol. 2017 Dec;10(12):e005767. doi: 10.1161/CIRCEP.117.005767.