louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06508567: Salvage MR-guided High-Dose-Rate Brachytherapy for Prostate Bed Recurrence After Radiotherapy in the PSMA PET Scan Era
Official title: Salvage MR-guided High-Dose-Rate Brachytherapy for Prostate Bed Recurrence After Radiotherapy in the PSMA PET Scan Era
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer Recurrent
Prostate Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 20
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 is an interventional, single-centre, single-arm, non-randomized, prospective, feasibility trial investigating salvage MR-guided High-Dose-Rate brachytherapy for prostate bed recurrence after postoperative radiotherapy.

Detailed description: Patients who received previous adjuvant or salvage radiotherapy to the prostate bed \>

Isolated prostate bed recurrence based on PSMA PET, biopsy-proven, and MR visible \>

Baseline: QoLs questionnaires, PSA, pelvic magnetic resonance imaging (MRI) scan for RT planning \>

Two fractions of 13 Gy each delivered over 7-21 days. GTV(HDR) delineation (based on MRI-guided and PSMA PET, biopsy data as applicable) \>

Follow-Up after treatment 60 months: PSA, CTCAE v5.0, MRI pelvis +/- PSMA-PET scan (optional at 24 months)

Eligibility criteria: Inclusion Criteria:

1. Patients who received previous RT to the prostate bed +/- pelvic nodal regions
2. Prostate-bed recurrence identified by biopsy and/or MRI and/or PSMA-PET scan
3. At least two continuous PSA elevations post RT and PSA above 0.2 ng/dl
4. With or without ADT PSA doubling time from nadir greater than 6 months
5. ECOG 0-2
6. Age greater than 18 years

Exclusion Criteria:

1. Radiological (e.g. PSMA PET, CT, MRI or bone scan) evidence of or distant metastases
2. History of ≥G3 gastrointestinal (GI) and genitourinary (GU) toxicities following RT
3. Any contraindications to MR and/or brachytherapy

Primary outcomes:
measure: Dosimetry Parameters
timeFrame: 5 Years
measure: Acute toxicity assessed by CTCAE V5.0 (Grade ≥3)
timeFrame: 5 Years
Secondary outcomes:
measure: Biochemical Control assessed by PSA
timeFrame: 5 Years
measure: Local Disease Control
timeFrame: 2 Years
measure: Changes in Quality of Life
timeFrame: 5 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
References:
Clinical trial NCT02540967: Drug Use Investigation of Gadovist.
Official title: Drug Use Investigation of Gadovist
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Magnetic Resonance Imaging
Image Enhancement
Keywords: Contrast enhancement in the following MR imaging
Brain and spine
Body and extremities
Gadobutrol
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-09-04
Enrollment: 3357
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female and male patients who planned Gd contrast enhanced MRI in accordance with approved label. Eligible patients who receive Gadovist will be enrolled and documented in the eCRF

Brief summary: The objectives of this study are to investigate the safety and effectiveness of Gadovist.

Detailed description: This is a prospective, non-interventional, continuous submission safety study that includes patients who planned Gadolinium (Gd) contrast enhanced Magnetic Resonance Imaging (MRI) in accordance with approved label. The investigator will have made the choice of Gd enhanced MRI (the decision to use Gadovist according the Japanese Package Insert prior to enrolling the patient in this study).

The study period is 3 years. Data analysis period is 1 year. In total, 3300 patients will be recruited.

For each patient, data are collected as defined in the case report form (CRF) at the visit for MRI examination (as per investigators routine practice).

Eligibility criteria: Inclusion Criteria:

* Patients who perform contrast enhanced Magnetic Resonance Imaging (MRI) with Gadovist.

Exclusion Criteria:

* Patients who are contraindicated based on approved label.

Primary outcomes:
measure: Number of episodes of adverse events as a measure of safety and tolerability
timeFrame: Up to 3 days
Secondary outcomes:
measure: Number of episodes of adverse drug reactions and adverse events
timeFrame: Up to 3 days
measure: Contrast enhancement
timeFrame: At the time of MRI
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
facility: Many Locations
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Tsushima Y, Awai K, Shinoda G, Miyoshi H, Chosa M, Sunaya T, Endrikat J. Post-marketing surveillance of gadobutrol for contrast-enhanced magnetic resonance imaging in Japan. Jpn J Radiol. 2018 Nov;36(11):676-685. doi: 10.1007/s11604-018-0778-4. Epub 2018 Sep 19.
Clinical trial NCT03469167: Study to Evaluate Efficacy and Safety of Wound Dressing Solution Containing EGF in Patients With Peptic Ulcers Bleeding
Official title: Clinical Study to Evaluate Efficacy and Safety of "CEGP003(Wound Dressing Solution Containing EGF)" for Achieving Hemostasis and Protecting Ulcer in Patients With Acute Peptic Ulcer Bleeding: A Prospective, Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peptic Ulcer Bleeding
Keywords: Bleeding
Lead sponsor: CGBio Inc.
Sponsor class: INDUSTRY
First posted: 2018-03-19
Enrollment: 76
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, single-blinded, randomized study to evaluate the efficacy and safety of CEGP003 in patients with acute peptic ulcers bleeding, compared to endoscopic epinephrine injection therapy.

Detailed description: CEGP003 is wound dressing solution containing Hydroxyethyl-cellulose and EGF. Epidermal growth factor (EGF) stimulates cell growth and differentiation by binding to its receptor, which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a peptic ulcers bleeding.

Eligibility criteria: Inclusion Criteria:

* Peptic ulcer with high-risk stigmata of recent hemorrhage (Forrest class IA, IB, IIA and IIB)

Exclusion Criteria:

* Subjects who have a history of malignant tumor in upper gastro-intestinal site
* Subjects with platelet and coagulation dysfunction (PLT \< 50E9/L, INR \> 2)
* Subjects that have taken anticoagulant drugs or non-steroidal anti-inflammatory drugs within 72 hours after the treatment
* Subjects with one or more bleeding sources
* Subjects who are pregnant or breast-feeding
* Subject who are allergic or have a hypersensitive reaction to Hydroxyethyl-cellulose or EGF
* Subjects who have undergone endoscopically therapies within the last 7 days
* Subjects who are considered not suitable for the study by significant disease
* Subjects who are not able to comply with the study requirements
* Subjects who are currently enrolled in another clinical study which can impact the study within 30 days of screening
* Subjects who are considered not suitable for the study by the investigator

Primary outcomes:
measure: Initial hemostasis rate
timeFrame: Within 10 minutes after first endoscopy session
Secondary outcomes:
measure: Recurrent bleeding rate
timeFrame: Within 72 hours
measure: Time required for treatment
timeFrame: 0 day
measure: Wound healing effect of peptic ulcer
timeFrame: After 3 days (72 hours)
measure: Usability for the delivery system
timeFrame: 0 day
Other outcomes:
Locations:
Study officials:
affiliation: Inha University Hospital
name: Don Haeng Lee, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Soon Chun Hyang University
name: Su Jin Hong, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05991167: EndeavorRx® Prospective Product Registry ("Expedition EndeavorRx")
Official title: EndeavorRx® Prospective Product Registry
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: ADHD
Keywords: ADHD
AKL-T01
EndeavorRx
Akili
Registry
Lead sponsor: Akili Interactive Labs, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-14
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who are prescribed EndeavorRx and activates their prescription are eligible to participate in this study.

Brief summary: The EndeavorRx Prospective Product Registry aims to collect real world data from participants receiving the digital therapeutic, EndeavorRx, under conditions of routine clinical practice.

Detailed description: The objectives of this registry are to describe clinical and demographic characteristics, prescribing patterns, treatment patterns, and outcomes in participants treated with EndeavorRx in a real-world setting.

Patients and their caregivers will be informed about the registry as part of a series of product welcome emails following product activation. Patients/caregivers enroll into the study by providing their electronic informed consent (eConsent) and assent (eAssent). All data are captured electronically and securely through a commercial data capture platform. Participants can also invite their child's teacher to submit surveys of their observations of the child's ADHD symptoms for the study. Study activities are emailed to caregivers at baseline, 1, 2, 3, and 6-months after enrollment.

A valid and active EndeavorRx prescription is required to enroll. However, an active prescription throughout the entire 6 months of study participation is not required.

Eligibility criteria: Inclusion Criteria:

* Are prescribed EndeavorRx by their healthcare provider as part of routine clinical practice
* Provide informed consent/assent to participate in the registry

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Clinical and demographic characteristics
timeFrame: Baseline
measure: Prescribing patterns
timeFrame: Months 1, 2, 3, and 6
measure: Treatment patterns
timeFrame: Baseline, Months 1, 2, 3, and 6
measure: Conners 3 ADHD Index - Parent Form
timeFrame: Baseline, Months 1, 2, 3, and 6
measure: Conners 3 ADHD Index - Teacher Form
timeFrame: Baseline, Months 1 and 3
measure: Global Impression of Perceived Difficulties (GIPD) assessment
timeFrame: Baseline, Months 1, 2, 3, and 6
measure: CAT-MH® ADHD module
timeFrame: Baseline, Months 1, 2, 3, and 6
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Akili Interactive Labs, Inc.
state: Massachusetts
Study officials:
affiliation: Akili Interactive Labs, Inc.
name: Scott H Kollins, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01490567: A Double-blind, Placebo-controlled Trial of Donepezil Adjunctive Treatment for Cognitive Impairment in Schizophrenia
Official title: Donepezil Adjunctive Treatment for Cognitive Impairment in Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Impaired Cognition
Schizophrenia
Keywords: Impaired Cognition Schizophrenia
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2011-12-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study was to study the effects of donepezil on cognition in patients with schizophrenia. The investigators conducted a 12-week, double-blind, placebo-controlled trial of donepezil as adjunctive treatment to antipsychotic drugs on patients with schizophrenia.

Detailed description: The investigators conducted a 12-week, double-blind, placebo-controlled trial of donepezil as adjunctive treatment to antipsychotic drugs on patients with schizophrenia.The trial will be complete in 2012.

Eligibility criteria: Inclusion Criteria:

* DSM-IV diagnosis of schizophrenia as determined by the Structured Clinical Interview for DSM-IV Axis I Disorders-Clinician Version;
* Between 18 and 40 years of age;
* Duration of the illness must be longer than 2 year;
* Patient's current antipsychotic medication regimen must be stable;
* Must be in a stable living arrangement;

Exclusion Criteria:

* Patient has mental retardation or severe organic brain syndromes;
* Treatment with Electroconvulsive Therapy (ECT) within 6 months prior to screening;
* Has suicidal attempts or ideation or violent behavior within the last 12 months;
* Patient has a history of alcohol/drug dependence;

Primary outcomes:
measure: Mean Change From Baseline in the Composite Score From the Cognition Assessment Battery After 12 Weeks of Treatment
timeFrame: 12 weeks
Secondary outcomes:
measure: Mean Change From Baseline in Cognition Assessment scores After 12 Weeks of Treatment
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Changsha
country: China
facility: the Second Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: Second Xiangya Hospital of Central South University
name: Xiaofeng Guo, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00983567: An Interactive Web-Based Program to Improve Food and Activity Choices of Teens
Official title: An Interactive Web-Based Program to Improve Food and Activity Choices of Teens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet
Physical Activity
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2009-09-24
Enrollment: 400
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will test a website for teens designed to help them improve both diet and physical activity. The website will have several components: educational messages, role model stories, goal setting, self-monitoring forms, problem solving, a monitored discussion forum, and diet and physical activity (PA) assessment questionnaires.

Detailed description: Increasing numbers of youth are at risk for becoming overweight because of poor diets and low physical activity levels. Prevention is key to reducing the obesity problem. Intervention programs must be easily accessible, and include intervention materials in a format that draws attention and interest. This study evaluates an 8-week web-based intervention for teens to promote healthy food and physical activity choices. The web program includes role model stories, nutrition and activity information pieces, goal setting and problem solving, and self-monitoring. Students will complete assessments at baseline, 8-weeks post, and then 6 and 12-months post intervention.

Eligibility criteria: Inclusion Criteria:

* ability to speak English
* 12-17 years old

Exclusion Criteria:

* no special diets

Primary outcomes:
measure: diet (fruit, vegetables, sweetened beverages, fat)
timeFrame: baseline, post, 6-and 12-months
Secondary outcomes:
measure: BMI
timeFrame: baseline, post, 6- and 12-months
measure: Physical activity:self-report
timeFrame: baseline, post, 6-and 12-months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Children's Nutrition Research Center
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Karen W Cullen, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01461967: A Study on Safety, Pharmacokinetics and Pharmacodynamics of RO5508887 in Healthy Volunteers
Official title: A Single-Center, Randomized, Double-Blind, Single and Multiple Ascending-Dose, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including the Effect of Food) and Pharmacodynamics of RO5508887 Following Oral Administration in Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-10-28
Enrollment: 49
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This randomized, double-blind, placebo-controlled, cross-over study will assess the safety, pharmacokinetics and pharmacodynamics of RO5508887 in healthy volunteers. In Part 1, subjects will be randomized to receive single ascending doses of either RO5508887 or placebo. In Part 2, subjects will receive a single dose of RO5508887 on two occasions, with or without food. Anticipated time on study is up to 12 weeks.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers, 18-45 (Part 1) or 18-65 (Part 2) years of age inclusive; healthy status is defined by absence of evidence of any active or chronic disease
* Body Mass Index (BMI) 18 to 30 kg/m2 inclusive
* Male subjects must use a barrier method of contraception for the duration of the study and for 30 days after the last dose

Exclusion Criteria:

* Suspicion of regular consumption of drugs of abuse
* Regular smoker (\>5 cigarettes, \>1 pipeful or \>1 cigar per day)
* Positive for hepatitis B, hepatitis C or HIV infection
* History of hypersensitivity or severe drug reaction
* Participation in an investigational drug or device study within three months before the first drug administration

Primary outcomes:
measure: Safety/tolerability: Incidence of adverse events
timeFrame: up to approximately 8 weeks
Secondary outcomes:
measure: Pharmacokinetics: Plasma concentrations of RO5508887
timeFrame: predose, 1.5, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 12, 24, 48, 72, 96, 144 hours post-dose
measure: Pharmacodynamics: Urine levels of RO5508887
timeFrame: predose to 72 hours post-dose
measure: Pharmacodynamics: Plasma levels of markers of amyloid deposition (Abeta1-40/Abeta1-42)
timeFrame: predose, 1.5, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 12, 24, 48, 72, 96, 144 hours post-dose
measure: Effect of food on pharmacokinetics (plasma concentrations) of a single dose of RO5508887
timeFrame: predose, 1.5, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 12, 24, 36, 48, 60, 72 hours post-dose
Other outcomes:
Locations:
city: Strasbourg
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01887067: Renal Denervation Therapy for Resistant Hypertension in Type 2 Diabetes Mellitus
Official title: Renal Denervation Therapy for Resistant Hypertension in Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypertension, Resistant
Diabetes Mellitus
Renal Denervation Therapy
Keywords: Hypertension
Diabetes Mellitus
Lead sponsor: Pamela Youde Nethersole Eastern Hospital
Sponsor class: OTHER
First posted: 2013-06-26
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To demonstrate the efficacy of renal denervation therapy in treating resistant hypertension and its effect on glucose metabolism in patients with type 2 diabetes mellitus


Eligibility criteria: Inclusion Criteria:

* Age ranges from 18 to 70 years inclusive
* Essential hypertension
* Office Systolic BP (SBP) ≥ 150 mmHg or Diastolic BP (DBP) ≥ 90mmHg
* 3 or more anti-hypertensive medications of different classes, including a diuretic, or documented intolerance to multiple medications
* Type 2 Diabetes Mellitus on oral hypoglycaemic agent (OHA)
* 2 functional kidneys; eGFR ≥ 45 mL/min/1.73m² (MDRD formula)
* Suitable renal anatomy compatible with the endovascular denervation procedure

Exclusion Criteria:

* Individual has renal artery anatomy that is ineligible for treatment including:
* Patients with secondary hypertension
* Myocardial infarction, unstable angina pectoris, cerebrovascular accident within 6 months
* Patient with type 1 diabetes mellitus
* Patient on insulin due to oral drug failure
* Renovascular abnormalities (including severe renal artery stenosis, previous renal stenting or angioplasty, or known dual renal arteries)
* Pregnancy
* Patient with any implantable device incompatible with radiofrequency energy delivery
* Hemodynamically significant valvular heart disease for which reduction of BP would be considered hazardous
* Any serious medical condition, which in the opinion of the investigator, may limit the life expectancy of patients or adversely

Primary outcomes:
measure: Change in office systolic & diastolic blood pressure from baseline to 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Change in office systolic and diastolic blood pressure up to 3 years
timeFrame: 3 years
measure: Change in insulin sensitivity
timeFrame: 12 months
measure: Change in glucose metabolism
timeFrame: 3 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Pamela Youde Nethersole Eastern Hospital
Study officials:
affiliation: Pamela Youde Nethersole Eastern Hospital
name: Kin Lam Tsui, FRCP (Edin, Glasg)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05608967: Effect of a Prehabilitation Mobile Application Versus Standard of Care Before Colon Cancer Surgery.
Official title: PREHapp Study Protocol: Effect of a Prehabilitation Mobile Application Versus Standard of Care Before Colon Cancer Surgery: a Randomized Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prehabilitation
mHealth
Usability
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population is made up of patients scheduled for colon surgery due to malignant pathology at the General Hospital of Elche. Patients must be 18 years of age or older, have an Android smartphone, and accept the prehabilitation program.

Brief summary: Pilot study to evaluate the effect of prehabilitation programme through a mobile application PREHapp in colon cancer surgery. The objectives of this pilot study were to evaluate the usability of the PREHapp for people undergoing colon cancer surgery, estimate the effect of the app on functional recovery after surgery and to evaluate complications during the postoperative period after 4 weeks of follow-up.


Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 18 years.
* Diagnosis of resectable colon cancer with elective surgery.
* Participants have at least 2 weeks to their operation date.
* Agree to collaborate in the study and sign the informed consent

Exclusion Criteria:

* Diagnosis of unresectable colon cancer.
* Inability to follow the prehabilitation programme.
* Participants be able to understand written and spoken Spanish.
* Subjects with previous nutritional supplements.
* Pre-anesthetic evaluation with results, according to the classification of the American Society of Anesthesiologists (ASA) IV or V.

Primary outcomes:
measure: Usability
timeFrame: 2 year
Secondary outcomes:
measure: Functional recovery
timeFrame: 2 year
measure: Complications
timeFrame: 2 year
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
Study officials:
References: