louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06129630: Effects of Nintendo Switch on Rehabilitation Programs for Elderly People With Cognitive Impairment
Official title: Effects of Nintendo Switch on Rehabilitation Programs for Elderly People With Cognitive Impairment: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Elderly People
Healthy Aging
Occupational Therapy
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 32
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control Group (CG), which received their usual sessions of conventional occupational therapy, and an Experimental Group (EG), which received therapy with Nintendo Switch, plus their conventional occupational therapy sessions.
Primary purpose: TREATMENT

Brief summary: Purpose: Healthy aging is the process of optimizing opportunities for health, participation and safety in order to improve quality of life as people age. This study aimed to provide healthy aging for people with cognitive impairment through the use of the Nintendo Switch combined with Occupational Therapy sessions.

Material and methods: a randomized clinical trial was conducted. The sample was randomized using a software program, OxMar, which allowed the separation of the sample into a control group (CG), which received their usual sessions of conventional occupational therapy, and an experimental group (EG), which received therapy with Nintendo Switch, plus their conventional occupational therapy sessions. An 8-week intervention was conducted with Nintendo Switch.

Measures: Nine Hole Peg Test, Box and Block Test, Barthel Index, WHOQOL-BREF, CSQ-8.


Eligibility criteria: Inclusion Criteria:

* Adult men or women, aged 65 years or older, cohabitating in the nursing home.
* Not presenting moderate or severe cognitive impairment measured through the MEC- Lobo test (score ≥ 24-35) (20).
* Agree to participate voluntarily, having read the project information sheet and signed the informed consent.

Exclusion Criteria:

* Presence of neurodegenerative pathology.
* Presence of physical pathology that compromised the person's safety.
* Severe cognitive impairment.

Primary outcomes:
measure: Nine Hole Peg Test
timeFrame: Pre-intervention and post-intervention (up to 1 week)
measure: Box and Block Test
timeFrame: Pre-intervention and post-intervention (up to 1 week)
measure: Barthel Index
timeFrame: Pre-intervention and post-intervention (up to 1 week)
measure: World Health Organization WHOQOL-BREF
timeFrame: Pre-intervention and post-intervention (up to 1 week)
Secondary outcomes:
measure: The Client Satisfaction Questionnaire-8, CSQ-8
timeFrame: Post-intervention (up to 1 week)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Physiocare Madrid Clinic
Study officials:
References:
Clinical trial NCT00283530: Tumor Phenotypes and Correlation to Clinical Outcomes in Cancer
Official title: Identification of Tumor Phenotypes and Correlation to Clinical Outcomes in Patients Diagnosed With Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cancer
Keywords: Cancer
Cancer receiving chemotherapy
Tumor biopsy
Lead sponsor: Kentuckiana Cancer Institute
Sponsor class: OTHER
First posted: 2006-01-30
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer subjects who have or will have tissue and or blood collected.

Brief summary: The purpose of this study is to identify the genetic makeup of cancers, the cancer response, and the correlation of the cancer response to standardized regimens of cancer treatment.

Detailed description: To identify the genetic makeup of cancers, the cancer response, and the correlation of the cancer response to standardized regimens of cancer treatment.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of cancer receiving chemotherapy
* Have had or will have tissue and/or blood samples collected

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Kentuckiana Cancer Institute
state: Kentucky
Study officials:
affiliation: Kentuckiana Cancer Institute
name: Shawn D. Glisson, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00781430: Study Evaluating The PK And Safety Of Neratinib In Healthy Subjects And Subjects With Chronic Liver Disease
Official title: An Open-Label, Single-Dose, Parallel-Group Study Of The Pharmacokinetics And Safety Of Neratinib In Subjects With Chronic Hepatic Impairment And In Matched Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Insufficiency
Lead sponsor: Puma Biotechnology, Inc.
Sponsor class: INDUSTRY
First posted: 2008-10-29
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to assess the pharmacokinetics of neratinib and to assess the safety and tolerability of neratinib in healthy subjects and subjects with chronic liver disease.


Eligibility criteria: Inclusion Criteria:

* Men or women of nonchildbearing potential (WONCBP) aged 18 to 65 years inclusive at screening.

WONCBP may be included if they are either surgically sterile (hysterectomy or oophorectomy) or postmenopausal for =1 year (with follicle-stimulating hormone \[FSH\] level =38 mIU/mL) and must have a negative serum pregnancy test result within 48 hours before administration of test article. 2-Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay. 3-Have a high probability for compliance with and completion of the study

Exclusion Criteria:

* Family history of QT prolongation, syncope, seizure, or unexplained cardiac-related death. 2-Presence or history of any disorder that may prevent the successful completion of the study. 3-History of drug abuse within 1 year before study day 1.

Primary outcomes:
measure: Plasma concentrations of neratinib in healthy volunteers compared to hepatically impaired patients through analysis of blod samples collected after neratinib administration in these 2 populations.
timeFrame: 4 weeks
Secondary outcomes:
measure: Safety based on adverse events monitoring, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
Study officials:
affiliation: Biotechnology
name: Puma
role: STUDY_DIRECTOR
References:
Clinical trial NCT05911230: Advanced Diffusion MRI to Differentiate Tumor Recurrence From Pseudoprogression in Patients With Glioblastoma and Brain Metastases
Official title: Advanced Diffusion MRI to Differentiate Tumor Recurrence From Pseudoprogression in Patients With Glioblastoma and Brain Metastases- AiD GLIO Pilot Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glioblastoma (GBM)
Keywords: Advanced Diffusion Weighted Magnetic Resonance Imaging (ADW-MRI)
Tumor Progress (TP)
Pseudo- Progression (PsP)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2023-06-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: one-arm, monocentric pilot trial
Primary purpose: DIAGNOSTIC

Brief summary: This pilot study investigates whether advanced diffusion-weighted MRI (ADW-MRI) can differentiate between true tumor progression (TP) and a pseudoprogression (PsP) in patients with glioblastoma (GBM) or brain metastases.

Detailed description: Advanced diffusion-weighted MRI (ADW-MRI) offer the opportunity of higher sensitivity towards subtle tissue changes associated with increased specificity relating to damage of different tissue components of the central nervous system (CNS). Within the framework of this study, conventional follow up MRI will be complemented by ADW-MRI in case of suspected tumor recurrence and possible surgical resection of the suspicious tissue. In the case of surgical resection, the histopathological findings will be correlated to the findings of the ADW-MRI. In the depicted pilot phase, the feasibility of the described protocol will be examined and the data concerning correlations between standard histopathologic and genetic workup of the resected tissue and the results concerning tissue features from ADW-MRI will be analyzed.

Eligibility criteria: Inclusion Criteria:

* Patients with histopathologically proven glioblastoma or brain metastasis and suspected tumor progress on standard MRI after first line therapy and who are candidates for elective surgical resection.
* Able to give informed consent

Exclusion Criteria:

* Contraindications to MRI (e.g. claustrophobia, pacemaker or other implants without MRI-approval, pregnancy)
* Patients in a life-threatening condition
* Patients in need of emergent surgery
* Histopathological analyses of insufficient quality
* Unable to give informed consent
* Age \<18 Years

Primary outcomes:
measure: Correlation of ADW-MRI-findings to histopathological findings
timeFrame: one time assessment at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Dominik Cordier, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06978530: 3D Custom Plate vs. Standard Titanium Plates for Mandibular Sub-condylar Fractures Fixation
Official title: Mandibular Sub-condylar Fractures Fixation Using Three-dimensional Custom Plate Versus Standard Titanium Fixation Plates: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mandibular Sub-condylar Fracture
Keywords: Mandibular fracture
3D custom plate
titanium miniplates
sub-condylar fractures
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized clinical trial aims to conduct a comprehensive clinical and radiographic evaluation by comparing the efficacy of standard titanium fixation plates with three dimensional custom plate in the management of sub-condylar fractures. By assessing the clinical outcomes, accuracy of reduction of the fracture segments, and bite force promoted by both fixation modalities.


Eligibility criteria: Inclusion Criteria:

* Displaced sub condylar fractures, requiring open reduction and rigid internal fixation
* Age ranges from 18 to 60 years
* Fracture duration less than 2 weeks
* Patients with adequate follow up duration for outcome assessment

Exclusion Criteria:

* Comminuted sub condylar fractures
* Patients with severe systemic diseases that may affect fracture healing
* Presence of any pathology at the fracture site
* Patients with previous history of mandibular surgery
* Medically compromised patients who are not fit to undergo surgery under general anesthesia
* Patients with in complete medical records or missing follow up data

Primary outcomes:
measure: Bite force
timeFrame: 1 month, 3 months, and 6 months postoperatively
Secondary outcomes:
measure: Maximum mouth opening
timeFrame: 1 month, 3 months, and 6 months postoperatively.
measure: Mandibular deviation on opening
timeFrame: 1 month, 3 months, and 6 months postoperatively.
measure: Accuracy of fracture reduction
timeFrame: Immediately postoperative (within 1 week)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01587430: 3 Anthracyclines, 2 Types of Consolidation With Different ARA-C Doses and Maintenance in Adult Acute Myeloid Leukemia
Official title: Multicenter Randomised Clinical Trial in Acute Myeloid Leukemia Treatment Based on Three Anthracyclines, Comparing Two Types of Consolidation With Different ARA-C Doses Followed by One Year Maintenance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Myeloid Leukemia
Keywords: acute myeloid leukemia
anthracyclines
high dose cytarabine
maintenance
Lead sponsor: National Research Center for Hematology, Russia
Sponsor class: NETWORK
First posted: 2012-04-30
Enrollment: 245
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal: to evaluate the role of high dose ara-c plus idarubicin and mitoxantrone consolidation followed by maintenance in the setting of high total cumulative anthracyclines dose(720-660 mg/m2).

Detailed description: In previous Russian AML multicenter studies it was shown that escalation of ARA-C dose (from 5,6 g to 72 g in 4 induction/consolidation courses) in parallel with anthracyclines dose reduction (from 630 mg/m2 to 285 mg/m2)did not improve survival, but decreased feasibility. In the ongoing trial we try to learn whether anthracyclines dose escalation (up to 720-660 mg m2) will or will not equivalise the standard (5,6 g in 4 induction/consolidation courses) and high (14,8 g) ARA-C doses.

Eligibility criteria: Inclusion Criteria:

* de novo acute myeloid leukemia - age 15-60

Exclusion Criteria:

* secondary acute myeloid leukemia
* acute myeloid leukemia from myelodysplastic syndrome
* Ph+ acute myeloid leukemia

Primary outcomes:
measure: overall survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: National Research Center for Hematology
Study officials:
affiliation: National Research center of Hematology
name: Valeriy G Savchenko
role: STUDY_DIRECTOR
References:
citation: Parovichnikova EN, Troitskaia VV, Kliasova GA, Kuz'mina LA, Sokolov AN, Paramonova EV, Galstian GM, Kessel'man SA, Drokov MIu, Vasil'eva VA, Obukhova TN, Kulikov SM, Savchenko VG. [Treating patients with acute myeloid leukemias (AML) according to the protocol of the AML-01.10 Russian multicenter randomized trial: the coordinating center's results]. Ter Arkh. 2014;86(7):14-23. Russian.
Clinical trial NCT01383330: A Clinical Trial to Evaluate Pharmacokinetics of Daewon DW-ES(A) 625mg/5ml, Daewon DW-ES(B) 625mg/5ml and Megace 800mg/20ml in Healthy Male Volunteers Under Fed Condition
Official title: Phase 1 Study of Daewon-ES(A) & Daewon-ES(B) in Healthy Male Volunteers Under Fed Condition
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: megesterol
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2011-06-28
Enrollment: 15
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate pharmacokinetics of Daewon DW-ES(A) 625mg/5ml, Daewon DW-ES(B) 625mg/5ml and Megace 800mg/20ml in healthy male volunteers under fed condition.


Eligibility criteria: Inclusion Criteria:

* Adult males aged 20 to 55 years at screening.
* No significant congenital/chronic disease. No symptoms in physical examination.
* Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis.
* Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation.

Exclusion Criteria:

* History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.
* History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.

History of known hypersensitivity to drugs including valsartan and pitavastatin.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01475630: Physical Therapy for Temporomandibular Joint (TMJ) Closed Lock
Official title: Randomised Controlled Trial on Physical Therapy PT) for TMJ Closed Lock
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Joint Disorders
Temporomandibular Joint Disc Displacement, Without Reduction
Keywords: temporomandibular joint
rehabilitation medicine
joint diseases
physical therapy
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2011-11-21
Enrollment: 49
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The aim of the present study was to investigate the effect of Physical Therapy (PT) on pain and mandibular function in patients with anterior disc displacement without reduction (ADD-R) or "closed lock" of the TMJ and this in a randomized controlled trial design.

Detailed description: The study evaluated the effect of extra, technical PT over the traditional information on the benign nature of the disease and the advice to refrain from overuse or misuse of the masticatory system as in parafunctions.

Eligibility criteria: Inclusion Criteria:

* All patients were recruited from the Oral Pain and Dysfunction Clinic and strictly satisfied the RDC-TMD criteria for .for disc displacement without reduction with (group IIb) or without (group IIc) limitation of mouth opening, based upon history and clinical examination. Additionally, pain experienced during the first examination had to be ≥ 35mm on a visual analog scale (VAS) of 100mm.

Exclusion Criteria:

* Patients were excluded if their medical history mentioned orofacial traumata (contusion or fracture), systemic disorders (e.g. rheumatoid arthritis, fibromyalgia), cervical disorders (operationalized as complaints, pain or referral patterns of pain provoked during movements of the cervical spine), neurologic disorders (e.g. trigeminal neuralgia, migraine or tension type headache), drug or alcohol abuse, use of antidepressant or hormonal medication. Participants did not receive therapy for symptoms of TMD within the last 2 months.

Primary outcomes:
measure: pain intensity
timeFrame: 1 year
Secondary outcomes:
measure: mouth opening
timeFrame: 1 year
measure: pressure pain threshold
timeFrame: 1 year
measure: mandibular function impairment questionnaire
timeFrame: 1 year
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: univ hospital sint Rafael, KULeuven
Study officials:
affiliation: Catholic University Leuven
name: Antoon De Laat, DDS,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Craane B, Dijkstra PU, Stappaerts K, De Laat A. Randomized controlled trial on physical therapy for TMJ closed lock. J Dent Res. 2012 Apr;91(4):364-9. doi: 10.1177/0022034512438275. Epub 2012 Feb 8.
Clinical trial NCT04226430: Effect of Cytosorb on Blood Levels of Inflammatory Biomarkers of Sepsis.
Official title: Effect of a Novel Extracorporeal Cytokine Apheresis Method on Endocan, Copeptin and Interleukin-6 Levels in Sepsis: an Observational Prospective Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Cytokine Storm
Keywords: Endocan
Copeptin
Interleukin-6
Cytosorb
Sepsis
Lead sponsor: University of Gaziantep
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 34
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This observational prospective study included patients, who were diagnosed with sepsis and treated in the reanimation ICU of Gaziantep University Hospital.

Brief summary: Background: There is still an evident need for useful biomarkers and effective therapeutic approaches regarding the challenging management of sepsis. The aim of the study is to evaluate the effect of each Cytosorb hemoadsorption therapy course on blood levels of inflammatory biomarkers of sepsis including endocan, copeptin, interleukin-6, procalcitonin, C-reactive protein.

Detailed description: This observational prospective study included patients, who were diagnosed with sepsis and treated in the reanimation ICU of Gaziantep University Hospital with Cytosorb therapy between June 1st, 2016 and June 30th, 2017. Sepsis was diagnosed according to The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).

Exclusion criteria of the study were: (i) cardiovascular disease, (ii) multiple traumas, (iii) malignancies, (v) incomplete clinical data.

Approval of the ethical committee (ethical committee approval number 2018/04-02) was obtained. Written informed consent was taken from each patient or their next-of-kin. Patient demographics including age, gender, and origin of sepsis were recorded. Arterial blood samples were taken from patients before and immediately after the Cytosorb therapy course.

Eligibility criteria: Inclusion Criteria:

* Patients, who were diagnosed with sepsis and treated in the reanimation ICU of Gaziantep University Hospital with Cytosorb therapy (Sepsis was diagnosed according to The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3))

Exclusion Criteria:

* cardiovascular disease,
* multiple traumas
* malignancies
* incomplete clinical data.

Primary outcomes:
measure: Effect of a novel extracorporeal cytokine apheresis method on endocan levels in sepsis
timeFrame: 13 months
measure: Effect of a novel extracorporeal cytokine apheresis method on copeptin levels in sepsis
timeFrame: 13 months
measure: Effect of a novel extracorporeal cytokine apheresis method on interleukin-6 levels in sepsis
timeFrame: 13 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: