louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04758104: Assessment of the Efficacy of Stereotactic Intracavitary Instillation of 90Yttrium Colloid
Official title: Assessment of the Efficacy of Stereotactic Intracavitary Instillation of 90Yttrium Colloid for Treatment of Cystic Lesions of the Brain: Open Label Individual Patient (OLIP) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuroepithelial Cyst
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Nova Scotia Health Authority
First posted: 2021-02-17
Enrollment: 1
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: To estimate the efficacy of intracavitary application of 90Yttrium colloid for the treatment of an adult with a cystic tumor in the brain by a single neurosurgeon.
Primary purpose: TREATMENT

Brief summary: Neuroepithelial cysts are rare, representing less than 1% of the intracranial cysts. Neuroepithelial cysts, are benign and mostly asymptomatic. These cysts are lined by thin columnar or low cuboidal epithelium. The CSF-like contents of the cyst are due to secretion of the epithelial cyst wall. Although mostly asymptomatic, symptoms can occur when the cyst enlarges; the specific symptoms vary according to the size (mass effect) and location of the lesion. Radioactive phosphorus (32P) and 90yttrium colloid are isotopes that have been used. These are approved in the United States and Europe. 32P is not available in Canada. We want to use 90yttrium colloid. There is evidence in the scientific literature that treatment with 90yttrium colloid injected into the cyst is effective in preventing the cyst from growing, effective in causing the cyst to get smaller and in some cases the cyst disappears.

Detailed description: In brief, a single patient has been identified as having a cystic tumor by diagnostic imaging and clinical expertise and based on standards of excellence in clinical care will be offered participation in the study for the intracystic implantation of 90yttrium colloid. This patient will be followed closely for 4 weeks following 90yttrium colloid treatment and then receive standard of care (http://neurosurgery.medicine.dal.ca).

Eligibility criteria: Inclusion criteria:

1. Cystic tumor
2. Required treatment
3. Adult over 17 years of age
4. Willingness to provide informed consent

Exclusion criteria

1. Solid tumor
2. Treatment not required
3. Child under 17 years of age
4. Not willing to provide informed consent

Primary outcomes:
measure: Demonstration of intracavitary application of 90Yttrium colloid into a cystic tumor in the brain.
timeFrame: 1 MONTH
measure: Shrinkage of cyst
timeFrame: 1 Month
Secondary outcomes:
measure: PET-CT scan will be used to visualize the yttrium within the cyst.
timeFrame: 1 -4 days
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
Study officials:
References:
Clinical trial NCT05059704: Circuit Class Training vs. Individual, Task Specific Training in Chronic Stroke Patient
Official title: Effects of Circuit Class Training vs. Individual, Task Specific Training on Upper Extremity Function in Chronic Stroke Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Spasticity
Motor function
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-09-28
Enrollment: 36
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Due to minimal volitional activation of the impaired arm, these individuals are less able to engage in activities of daily living (ADL's). Moreover, simultaneous use of the hand and arm are needed throughout ADL's. The effects of these two approaches (circuit class training and individual task-specific training) on upper extremity function and activities of daily living (ADL's) have not yet been clearly identified, and studies on its effects on chronic stroke patients are limited.

Detailed description: several research found that circuit training improved various functional parameters after stroke. And most of the circuit based tasks from the published studies were focused on the leg strength, walking speed, distance and balance etc. Previous literature found that circuit class training is effective in improving upper extremity function in chronic stroke patients disregarding the type of stroke and the results of that study are not generalized for chronic stroke patients with upper extremity deficit. Secondly, circuit class training and task-specific training are effective for improving upper limb function following a stroke but in the acute stage. In fact, there is no evidence in which comparison of these two approaches has been done in chronic stroke patients and thirdly, between these two approaches which approach is more effective towards improving upper limb function in chronic stage.

Eligibility criteria: Inclusion Criteria:

* Mini-Mental State Examination score more than 24
* Chronic stage (i.e. post-stroke duration of 6 months)
* Single episode of stroke
* MAS of 1 to 3 at upper extremity.
* MRS of ≤ 3 at lower extremity.
* MCA stroke
* Scores 32 to 47 on Fugl-Meyer Upper Extremity Scale (FMA-UE)

Exclusion Criteria:

* Orthopedic conditions that affect the UE function.
* Other neurological conditions, like PD, MS etc.

Primary outcomes:
measure: Fugl-Meyer Assessment Scale
timeFrame: 8 weeks
Secondary outcomes:
measure: Modified Ashworth Scale
timeFrame: 8 weeks
measure: Stroke Specific-Quality of Life Urdu Version (SS-QOL)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Gujrāt
country: Pakistan
facility: Al Mustafa Trust Medical and Physiotherapy Centre
state: Punjab
Study officials:
affiliation: Riphah International University
name: Mirza Obaid Baig, MSPT(NMR)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02841904: The Accuracy of Optic Biopsies Versus Conventional Biopsies for the Diagnosis of Superficial Bladder Neoplasia
Official title: The Accuracy of Probe-based Confocal Laser Endomicroscopy Versus Conventional Endoscopic Biopsies for the Diagnosis of Superficial Bladder Neoplasia.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bladder Cancer
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2016-07-22
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study evaluates the accuracy of Confocal Laser Endomicroscopy (CLE) in the diagnostic of non-invasive flat and exophytic bladder neoplasia. CLE results are compared to histopathology results.

Detailed description: Confocal Laser Endomicroscopy (CLE) is a technique which during endoscopic examination of the bladder (cystoscopy) gives magnified, microscopic-like images of tissues and cells, by inserting a laser fiber through the cystoscope. CLE aims to target biopsies during cystoscopy and reduce the number of biopsies, and the need for additional cystoscopies i general anesthesia.

This study evaluates the ability of CLE to assess tissue in the bladder. The ability to diagnose normal mucosa, inflammation and tumors of the bladder by the CLE is compared to the histopathological examination of selected tissues (biopsies).

Patients scheduled for cystoscopy with biopsies in general anesthesia are recruited for the study. After standard cystoscopy where suspicious mucosal areas are located and marked, A contrast agent (Fluorescein) is administrated intravenously. CLE fiber is introduced through the cystoscope and the marked mucosal areas are examined by direct contact with the laser fiber. The pathologist assesses the CLE video and registers the results. Biopsies are then taken from the selected, suspicious areas. The results of CLE assessment are compared with the histopathological results.

Eligibility criteria: Inclusion Criteria:

* First time Transurethral Resection of Bladder (TURB) for bladder tumors under 3 cm
* Suspicious mucosa / Carcinoma in situ
* Recurrent pTa
* Positive cytology with normal flexible cystoscopy
* Control after Bacille Calmette Guérin (BCG) treatment

Exclusion Criteria:

* Allergy to fluorescein
* Pregnant and lactating women.
* Renal failure (eGFR \<20 ml / min)

Primary outcomes:
measure: accordance between CLE and histology in flat bladder tumors
timeFrame: An average of 18 months
measure: Accordance between CLE and histology in exophytic bladder tumors
timeFrame: An average of 18 months
Secondary outcomes:
measure: Accordance between CLE assessed by the surgeon and histology.
timeFrame: An average of 18 months
measure: Accordance between the per-operative evaluation of CLE of the pathologist and the surgeon
timeFrame: An average of 18 months
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Urology department
Study officials:
affiliation: Herlev Hospital
name: Sami Beji, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06671704: GC-PRO Intervention
Official title: GC-PRO Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Cardiovascular Diseases
Prenatal Condition
Reproductive Condition
Genetic Condition
Keywords: genetic counseling
cancer
heart disease
reproductive
prenatal
genetic
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: University of South Florida
First posted: 2024-11-04
Enrollment: 994
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Stepped wedge randomized controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of the GC-PRO study is to try to make genetic counseling better for people of all backgrounds. We are asking participants to complete two surveys and to allow audio recording of their genetic counseling visit. The purpose of the study is to understand whether trying different ways of doing genetic counseling will lead to better experiences for patients. The research team is also working with partners from the Somali, Latino/Hispanic, Black/African American, and Hmong communities to make sure the research is being done in a way that will benefit underserved communities.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* individual OR their child has been referred to genetic counseling for family and/or personal history of hereditary cancer, cardiology condition, general genetics indication, or reproductive/prenatal indication at a participating study site
* understand and be able to provide information for study forms and surveys in English.

Exclusion Criteria:

* Unable to provide informed consent
* For pediatric genetic counseling referrals, individuals who are not the parent or legal guardian of the child will be excluded from participating.

Primary outcomes:
measure: effectiveness of a genetic counseling skills training intervention
timeFrame: 1 month
Secondary outcomes:
measure: patient perception of overall GC quality
timeFrame: 1 month
measure: patient-centered communication
timeFrame: 1 month
measure: patient empowerment
timeFrame: 1 month
measure: patient activation
timeFrame: 1 month
measure: patient information needs met / information overload
timeFrame: 1 month
measure: patients' perceived trust in GC
timeFrame: 1 month
measure: working alliance
timeFrame: 1 month
measure: GC verbal dominance
timeFrame: 1 month
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Heather Zierhut
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00531804: A Multiple Ascending Dose Study of R1450 in Patients With Alzheimer Disease.
Official title: A Multi-center, Multiple-ascending Dose, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO4909832 Following Intravenous Infusion in AD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of R1450 in patients with mild to moderate Alzheimer Disease. Patients will be randomized to receive either R1450 or placebo by intravenous infusion for a total of 7 doses. The starting dose will be escalated in subsequent cohorts of patients in an adaptive manner, after a satisfactory assessment of safety, tolerability and pharmacokinetics of the previous dose. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, 50-90 years of age;
* diagnosis of probable Alzheimer Disease, with symptoms \>=1 year prior to screening;
* meets DSM-IV criteria for Alzheimer-type dementia;
* stabilised on approved medications for treatment of Alzheimer Disease for \>=4 months prior to baseline.

Exclusion Criteria:

* active major depressive disorder, or a history of bipolar disorder;
* history of schizophrenia;
* concurrent participation in a non-pharmacological trial with a key objective of improving cognition;
* prior randomisation in any R1450 trial.

Primary outcomes:
measure: AEs, laboratory parameters, vital signs.
timeFrame: Throughout study
measure: Pharmacokinetic parameters of R1450 in plasma
timeFrame: Throughout study
Secondary outcomes:
measure: CSF biomarkers, clinical efficacy parameters.
timeFrame: Throughout study
Other outcomes:
Locations:
city: København
country: Denmark
city: Ramat Gan
country: Israel
city: Amsterdam
country: Netherlands
city: Malmoe
country: Sweden
city: Stockholm
country: Sweden
city: Blackpool
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Southampton
country: United Kingdom
city: Swindon
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04962204: Virtual Visitation in Intensive Care Unit Study
Official title: Efficacy of Virtual Visitation in Intensive Care Unit During COVID-19 Pandemic: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Critically Ill Patients
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional group Control group
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to identify the efficacy of virtual visitation in Intensive Care Unit on patients and their caregivers during COVID-19 Pandemic.

Detailed description: After being informed about the study, all patients who meet the eligibility requirements will be randomized in a 1:1 ratio to intervention group (Virtual visitation once a day) or Control group (Phone interviews once a day).

Eligibility criteria: Inclusion Criteria:

* Patients who are expected to stay in the intensive care unit for more than 48 hours
* Patients with a RASS score of -2 or higher

Exclusion Criteria:

* Patients who discharge or die within 48 hours of admission to ICU

Primary outcomes:
measure: FS-ICU score from caregivers at discharge or 7 days after initiation of study enrolled
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
Study officials:
References:
Clinical trial NCT02461004: CKD-391 Pharmacokinetic Study
Official title: Clinical Trial to Assess the Pharmacokinetic Characteristics and Safety/Tolerability of CKD-391 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Dyslipidemia
CKD-391
Atorvastatin
Ezetimibe
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2015-06-03
Enrollment: 52
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomized, open-label, 2-way crossover study to compare the pharmacokinetics and safety CKD-391 to coadministration Atorvastatin and Ezetimibe in health volunteers.

Detailed description: To compare the CKD-391 (Experimental product) to the dose Atorvastatin calcium and Ezetimibe combination in health male subjects is the purpose of this trial.

Following are evaluated in this trial; Characteristics and safety/Tolerability Of CKD-391.

Eligibility criteria: Inclusion Criteria:

* Bwt \>=50kg, BMI 18\~29
* signed the informed consent form prior to the study participation

Exclusion Criteria:

* Clinically significant disease
* Subject has signs of symptoms of acute disease within 28 days of starting administration of investigational drug
* Clinically significant allergic disease
* Impossible to taking the institutional standard meal
* Previously donate whole blood within 60 days or component blood within 20 days
* Previously participated in other trial within 90 days
* Continued to be taking caffeine (caffeine \> 5 cup/day), drinking(alcohol \> 30 g/day) or cannot stop drinking or severe heavy smoker(cigarette \> 10 cigarettes per day)during clinical trials
* An impossible one who participates in clinical trial by investigator's decision including laboratory test result

Primary outcomes:
measure: AUClast
timeFrame: up to 96 hours post dose
measure: Cmax
timeFrame: up to 96 hours post dose
Secondary outcomes:
measure: Tmax
timeFrame: up to 96 hours post dose
measure: T1/2
timeFrame: up to 96 hours post dose
measure: AUCinf
timeFrame: up to 96 hours post dose
measure: Adverse events
timeFrame: up to 24days post dose
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Korea University Anam Hospital
Study officials:
affiliation: The Korea University Anam Hospital
name: Ji Young Park, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06073704: Effects of Adjunct Antimicrobial Photodynamic Therapy in Periodontal Treatment of Patients with Obesity
Official title: Effects of Antimicrobial Photodynamic Therapy in Non-surgical Periodontal Treatment of Patients with Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontitis
Obesity
Keywords: periodontitis
obesity
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the effects of adjuvant antimicrobial photodynamic therapy (aPDT) as an adjuvant of scaling and root planing with scaling and root planing alone for periodontal treatment in patients with periodontal disease and obesity. The main question it aims to answer are: Does adjuvant aPDT improves periodontal health? Are there differences in the proteomic profile of gingival fluid after both treatments? Participants will receive scaling and root planing complemented or not by aPDT. Results will be collected after 1, 3, and 6 months. Researchers will compare adjuvant aPDT treatment to regular treatment to see if it promotes reduction in inflammation and improvement in periodontal health.


Eligibility criteria: Inclusion Criteria:

* Obesity (grade II and III classified according to Body Mass Index)
* Periodontitis stage II to IV
* Presence of at least 20 teeth excluding 3rd molars.

Exclusion Criteria:

* Smokers
* Alcohol or drugs consumption
* Kidney disorders
* Pregnancy or lactation
* Use of antibiotics at the last 30 days
* Use of drugs that alter periodontal structures as phenytoin or ciclosporin
* Periodontal treatment at the last 6 months

Primary outcomes:
measure: Probing depth
timeFrame: Baseline, 1, 3 and 6 months
measure: Clinical attachment level
timeFrame: Baseline, 1, 3 and 6 months
Secondary outcomes:
measure: Changes on bleeding on probing
timeFrame: Baseline, 1,3,and 6 months
measure: Differences in proteomics
timeFrame: baseline, 3 and 6 months
Other outcomes:
Locations:
city: Bauru
country: Brazil
facility: Bauru School of Dentistry
state: São Paulo
Study officials:
References:
citation: Vohra F, Akram Z, Bukhari IA, Sheikh SA, Javed F. Short-term effects of adjunctive antimicrobial photodynamic therapy in obese patients with chronic periodontitis: A randomized controlled clinical trial. Photodiagnosis Photodyn Ther. 2018 Mar;21:10-15. doi: 10.1016/j.pdpdt.2017.10.022. Epub 2017 Oct 27.
citation: da Silva-Junior PGB, Abreu LG, Costa FO, Cota LOM, Esteves-Lima RP. The effect of antimicrobial photodynamic therapy adjunct to non-surgical periodontal therapy on the treatment of periodontitis in individuals with type 2 diabetes mellitus: A systematic review and meta-analysis. Photodiagnosis Photodyn Ther. 2023 Jun;42:103573. doi: 10.1016/j.pdpdt.2023.103573. Epub 2023 Apr 14.