louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03641833: Identification of Factors Causing Postoperative Cognitive Dysfunction in Patients Undergoing Cardiac Surgery With CPB
Official title: Identification of Factors Causing Postoperative Cognitive Dysfunction in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass (CPB)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Cognitive Dysfunction
Keywords: cardiac
surgery
postoperative cognitive dysfunction
bypass
brain biomarkers
transcranial Doppler
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2018-08-22
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study include patients undergoing cardiac at Clinic of Cardiac, Vascular and Thoracic Surgery, Lithuanian University of Health Sciences

Brief summary: The incidence of cognitive decline occurs in 53% of patients after cardiac surgery. Causes of POCD can be various: age, duration of cardiac bypass, medicaments and many others. The aim of this study is to determine factors causing postoperative cognitive dysfunction (POCD) and to identify which of them are most important

Detailed description: Prospective case-control study included patients undergoing cardiac at Clinic of Cardiac, Vascular and Thoracic Surgery, Lithuanian University of Health Sciences. Inclusion criteria is: 1) cardiac output \> 35%; 2) no agents affecting central nervous system; 3) no neuropathology; 5) no multiple organ dysfunction. Patients will have to perform mini mental state examination (MMSE), Trial making, addenbrooke tests before and 7 days after surgery. Brain biomarkers glial fibrillary acid protein (GFAP) and neurofilaments will be taken after induction, 24 and 48 hours after surgery. Transcranial Doppler will be performed to evaluate a.cerebri media blood flow speed during surgery.

After these test, the investigators are going to examine data about patient and operation, recognize factors causing POCD and identify the most important of them.

Eligibility criteria: Inclusion Criteria:

* Coronary artery bypass grafting or/and heart valve surgery;
* Patients age\>18years
* Cardiac output \>35%

Exclusion Criteria:

* Patient disagreement;
* Diseases causing cognitive dysfunction;
* Multi organic deficiency;
* Agents affecting central nervous system

Primary outcomes:
measure: Brain blood flow speed changes during surgery and correlation with POCD
timeFrame: 3 years
Secondary outcomes:
measure: Brain biomarker GFAP concentration chances before and after surgery and correlation with POCD.
timeFrame: 3 years
measure: Brain biomarker neurofilaments concentration chances before and after surgery and correlation with POCD.
timeFrame: 3 years
Other outcomes:
measure: Determine factors causing POCD
timeFrame: 3 years
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian University of Health Sciences
state: Outside US/Canada/Australia
Study officials:
References:
Clinical trial NCT06913933: Static vs. Dynamic Progressive Splinting for Persistent Wrist Stiffness After DRF
Official title: A Two-Arm, Parallel-Group Randomized Controlled Trial Comparing Static Progressive Splinting Versus Dynamic Splinting for Improving Wrist PROM/AROM in Patients With Persistent Post-DRF Stiffness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Distal Radius Fractures
Lead sponsor: Al Hayah University In Cairo
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized into two parallel arms. One arm will receive a static progressive splint, and the other a dynamic splint, each used in addition to a weekly supervised therapy session. The splints are used to address persistent ROM limitations after conventional therapy has plateaued.
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial will compare the effectiveness of static progressive splinting versus dynamic splinting for treating persistent wrist stiffness in adults ≥18 years old at least 8 weeks post distal radius fracture (DRF) injury. Both splinting modalities are provided as an adjunct to one weekly supervised therapy session over a 6-week period. The primary outcomes are wrist active and passive range of motion (AROM/PROM) measured using goniometry, with secondary outcomes including patient-reported wrist function (PRWE), overall satisfaction, and adverse events.


Eligibility criteria: Inclusion Criteria:

Adults aged 18 years or older. At least 8 weeks post distal radius fracture (operative or nonoperative) who have completed standard rehabilitation.

Demonstrated persistent wrist stiffness with ≤50% of contralateral wrist extension or flexion.

Capable of providing written informed consent and complying with study procedures

Exclusion Criteria:

Presence of complex regional pain syndrome (CRPS) or active fracture healing issues.

History of significant wrist pathology unrelated to the DRF. Uncontrolled medical conditions that would interfere with splint application or therapy.

Known skin conditions or allergies that preclude orthosis use. Inability or unwillingness to adhere to the intervention protocol or follow-up schedule.

Pregnant or breastfeeding individuals.

Primary outcomes:
measure: Wrist Active and Passive Range of Motion (AROM/PROM)
timeFrame: Assessed at baseline, 6 weeks (post-intervention), and 3 months follow-up.
Secondary outcomes:
measure: Patient-Rated Wrist Evaluation (PRWE)
timeFrame: Assessed at baseline and at 6 weeks post-intervention.
measure: Patient Satisfaction
timeFrame: Collected at 6 weeks and 3 months post-intervention.
measure: Incidence of Adverse Events
timeFrame: Continuously monitored from baseline to the 3-month follow-up.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy, Al Hayah University
Study officials:
References:
Clinical trial NCT03098433: Effects of Liothyronine on Energy Expenditure and Cardiovascular Function
Official title: Effects of Liothyronine on Energy Expenditure and Cardiovascular Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2017-03-31
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: double blind, crossover
Primary purpose: OTHER

Brief summary: This study will assess the short term effects of a single dose of liothyronine on the cardiovascular system and energy expenditure


Eligibility criteria: Inclusion Criteria:

* BMI \>20\<30 kg/m2
* TSH \>0.5\<5.0 mcIU/mL
* Negative TPO antibodies

Exclusion Criteria:

* Pregnancy
* Use of prescription drugs
* Diabetes mellitus
* Coronary artery disease
* Hypertension
* Anemia
* Renal insufficiency
* Liver disease or ALT \>2.5 x the upper laboratory reference limit

Primary outcomes:
measure: Cardiac Output
timeFrame: five hours
Secondary outcomes:
measure: Energy Expenditure
timeFrame: five hours
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Francesco S Celi, MD, MHSc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen S, Wohlford GF, Vecchie' A, Carbone S, Yavuz S, Van Tassell B, Abbate A, Celi FS. Acute Effects of Liothyronine Administration on Cardiovascular System and Energy Metabolism in Healthy Volunteers. Front Endocrinol (Lausanne). 2022 Feb 28;13:843539. doi: 10.3389/fendo.2022.843539. eCollection 2022.
Clinical trial NCT02705833: Head and Neck Cancer Treatment Patterns and Outcomes Research Study in France, Germany, and Canada
Official title: Head and Neck Cancer Treatment Patterns and Outcomes Research Study in France, Germany, and Canada
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-03-11
Enrollment: 591
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with R/M SCCHN between 01July2013 and 30June2014

Brief summary: The primary objective of the study is to characterize the medical management of squamous cell carcinoma head and neck (SCCHN) patients diagnosed with recurrent/metastatic (R/M) disease (between 01July2013 and 30 June 2014) in the real-world setting.


Eligibility criteria: Inclusion Criteria:

* Adult patient (18 years old or older) with a confirmed diagnosis or R/M head and neck, may be living or deceased at time of enrollment in the study
* Diagnosis of R/M head and neck cancer between 01July2013 and 30June2014 (study index period)

Exclusion Criteria:

* If female patient, pregnant or lactating between 01July2013 and 30June2014
* Enrolled in cancer treatment-clinical trials since diagnosis of R/M head and neck cancer during the study index period

Primary outcomes:
measure: Best Therapy Response defined as Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD) based on physician's assessment for each therapy regimen
timeFrame: approximately 12 months
measure: Overall Survival(OS) of patients with an Index diagnosis of R/M SCCHN
timeFrame: approximately 12 months
measure: Progression-Free Survival(PFS) of patients with an Index diagnosis of R/M SCCHN
timeFrame: approximately 12 months
measure: Recurrent-Free Survival(RFS) of patients with an Index diagnosis of R/M SCCHN
timeFrame: approximately 12 months
measure: Overall Response Rate(ORR) of patients with an Index diagnosis of R/M SCCHN
timeFrame: approximately 12 months
Secondary outcomes:
measure: Frequency of R/M SCCHN-related health care resource use
timeFrame: approximately 12 months
measure: Treatment selection conditional on patient demographics, comorbidities, disease severity, and other characteristics as well as clinician demographics, therapy preferences, and other characteristics
timeFrame: approximately 12 months
measure: Best Therapy Response conditional on patient demographics, comorbidities, disease severity, treatment received, and other characteristics
timeFrame: approximately 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02263833: An Observational, Prospective, Safety Study of Mircera (Monopegylated Epoetin Beta) in Clinical Practice
Official title: Post Marketing Surveillance of Mircera®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Disease, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-10-13
Enrollment: 748
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: Participants with chronic renal anemia regardless of pre-dialysis / dialysis in Korea. Participants who were prescribed Mircera by their physician according to the local Korean Mircera label, for the treatment of anemia associated with chronic kidney disease who require ESA therapy could be included in the study.

Brief summary: This national study was a post-marketing surveillance study conducted in Korea from 29 August 2008 to 28 August 2012 to meet local regulatory requirements for Mircera (monopegylated-epoetin beta). Prospective participant-based data collection was evaluated for safety/risk assessments and effectiveness. No specific study-related procedures are required. Participants were to be followed up as long as possible at the physician's discretion.


Eligibility criteria: Inclusion Criteria:

* Adult, aged \>18 years
* Participants with stage 3-5 chronic kidney disease and hemodialyzed participants
* Signed informed consent

Exclusion Criteria:

* Current participation in a clinical study

Primary outcomes:
measure: Percentage of Participants With an Adverse Event (AE) and a Serious Adverse Event
timeFrame: At physician's discretion, up to 4 years
measure: Percentage of Participants With an Adverse Drug Reaction (ADR)
timeFrame: At physician's discretion, up to 4 years
Secondary outcomes:
Other outcomes:
measure: Percentage of ESA Naïve Participants Having an Increase in Hemoglobin (Hb) Level of at Least 1 g/dL From Baseline and Reaching the Hb Level Greater Than or Equal to (>/=) 11 g/dL Without Red Blood Cell Transfusion
timeFrame: Up to 4 years
measure: Percentage of Participants on ESA Therapy Who Were Switched to Mircera Having a Hemoglobin Concentration in the Range of 10 to 12 g/dL
timeFrame: Up to 4 years
Locations:
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06741033: Comparing the Effect of Toe-in Gait Modification Along With Conventional Physiotherapy in People With Medial KO
Official title: Comparing the Effect of Toe-in Gait Modification Along With Conventional Physiotherapy in People With Medial Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 34
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Medial knee osteoarthritis (OA) remains a prevalent and debilitating condition, despite conventional physiotherapy interventions aimed at reducing pain and improving function. This study investigates the additional benefits of toe-in gait modification when combined with conventional physiotherapy in individuals with medial knee OA. Rooted in biomechanical theories suggesting that altering gait patterns can reduce medial knee load, this research employs a randomized controlled trial methodology.

Detailed description: Participants are divided into two groups: one receiving conventional physiotherapy alone, and the other receiving a combination of conventional physiotherapy and toe-in gait modification. Outcomes are assessed over a 8-week period, focusing on pain levels and physical function. The significance of this study lies in its potential to enhance current treatment protocols, offering a more effective, non-invasive intervention to alleviate symptoms and improve the quality of life for those suffering from medial knee OA. The findings could inform clinical practices and pave the way for personalized rehabilitation strategies that incorporate gait modifications, ultimately reducing the healthcare burden associated with knee osteoarthritis.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of MKOA having Grade 1-3 (radiographic evidence of MKOA)
* Knee pain on most days of previous month. (The most symptomatic side will consider the study limb for participants with bilaterally eligible knees)
* Age \> 45
* Ability to walk unaided for at least 25 min
* Gender eligibility both male and female

Exclusion Criteria:

* Severe MKOA (Grade 4)
* Lateral OA
* Patella femoral OA
* Previous or planned hip or knee surgery
* Hip or ankle arthritis
* Rheumatoid arthritis
* Severe valgus and varus alignment requiring the use of an assistive device and the inability to walk independently
* Neurological dysfunction

Primary outcomes:
measure: NUMERIC PAIN RATING SCALE (NPRS)
timeFrame: 12 Months
measure: WOMAC scale
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Institute of orthopedic and rehabilitation IOR garden town
state: Punjab
Study officials:
References:
Clinical trial NCT05793333: Predictors of Node Positivity in Endometrial Cancer
Official title: Histological and Molecular Characteristics Predict the Risk of Nodal Involvement in Endometrial Cancer: a Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometrial Cancer
Keywords: sentinel node
endometrial cancer
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 200
Sex: FEMALE
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: Patietns were submitted to standard treatment modality for managing endometrial cancer. They will receive hsyterectomy (with or without bilateral salpingo-oophorectomy) plus sentinel ndoe mapping.

After the procedures data regarding hystologcial charactersitcs of the tumor and molecular features will be analyzed (as routine cliical practice).

We will correlate those data with findings achieved by sentinel nodes

Brief summary: To investigate the role of histological and moleculr profile of endometrial cancer patietns in predicting the risk of nodal metastases in endometrila cancer patients.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Histologically confirmed endometrila cancer
* Data on molecular genomic profiling (POLE mutated, p53 abnormalities, MMRd/MSI-H, and NSMP)
* Data on histological characteristics of the ttumor
* Execution of sentinel node mapping
* Data on sentinel node status (negative vs. positive)

Exclusion Criteria:

* Stage IVB endoemtrial cancer
* consent withdraw

Primary outcomes:
measure: positive nodes
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
state: Lombardia
Study officials:
affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
name: Giorgio Bogani, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02579733: Azathioprine Based on Endoscopy After Clinical Remission in Moderate to Severe Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Ulcerative Colitis
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
Collaborators: name: Celltrion
First posted: 2015-10-20
Enrollment: 16
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: The aim of this study is to determine whether azathioprine is effective for mucosal healing in UC patients who achieved clinical remission by the first course of corticosteroids but not mucosal healing in endoscopy.

Detailed description: The sample size was calculated based on the previous study showing the difference of mucosal healing rate between azathioprine (58%) and 5-aminosalicylate (21%). With a two-tailed test of α = 0.05 and 1 - ß = 0.8, 52 patients were required.

The placebo drug which is identical to azathioprine will be provided by Celltrion drug company.

Differences in the categorical variables between the groups are examined with χ2 or the Fisher exact test. For comparisons of continuous variables, a Student t test is used.

Eligibility criteria: Inclusion Criteria:

* Ulcerative colitis patients with moderate to severe activity who achieved a clinical remission by the first course of corticosteroids
* Newly diagnosed or without steroid use during last 1 year
* Endoscopic Mayo subscore \>0

Exclusion Criteria:

* Patients with azathioprine or biologics therapy

Primary outcomes:
measure: Mucosal healing status
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
Study officials:
affiliation: Kyungpook National University Hospital
name: Eun Soo Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03006133: Prevalence of Bruxism in a Group of Preschool Egyptian Children
Official title: Prevalence of Bruxism in a Group of Preschool Egyptian Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bruxism
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-12-30
Enrollment: 362
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: preschool Egyptian children

Brief summary: The protocol is to show the prevalence of bruxism among a group of Egyptian children

Detailed description: Many studies are done on children to show the prevalence of bruxism among different ages , reports of prevalence range from 8-31% in the general population, the prevalence of bruxism in Egyptian children is unknown. Several symptoms are commonly associated with bruxism, including hypersensitive teeth, aching jaw muscles, headaches, tooth wear, damage to dental restorations (e.g. crowns and fillings) and damage to teeth. However it may cause minimal symptoms, and therefore people may not be aware of the condition,so this study is important to determine the prevalence of bruxism of preschool Egyptian children

Eligibility criteria: Inclusion Criteria:

1. Cooperative children from 3-6 years
2. Children without any Medical problems
3. Children of families who accept to participate in the study

Exclusion Criteria:

1- Children with caries in posterior teeth

Primary outcomes:
measure: Prevalence of Bruxism
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo Governorate
country: Egypt
facility: Manal Ahmed
state: Manial
Study officials:
References: