louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06753929: Assessment of CSF Shunt Flow in an Outpatient Setting with a Thermal Measurement Device
Official title: Assessment of Flow in Cerebrospinal Fluid Shunts with a Wireless Thermal Anisotropy Measurement Device During Routine Outpatient Surveillance Visits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hydrocephalus
Lead sponsor: Rhaeos, Inc.
Sponsor class: INDUSTRY
First posted: 2024-12-31
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study collects exploratory data using a non-invasive device for assessing CSF shunt flow using thermal anisotropy measurements. Patients with an existing implanted ventricular CSF shunt will be enrolled into either a prospective (study device) or retrospective (no study device) cohort to gather data on health resource utilization, quality-of-life, and study device measurements.


Eligibility criteria: Inclusion criteria

1. Existing ventricular cerebrospinal fluid shunt
2. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
3. Subject available for 2 week follow-up
4. Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt that crosses the clavicle; region of skin is appropriate in size for application of the study device (Cohort A only)

Exclusion Criteria

1. Presence of more than one distal shunt catheter in the study device measurement region
2. Presence of an interfering open wound or edema in the study device measurement region
3. Subject-reported history of serious adverse skin reactions to silicone-based adhesives
4. Participation in the study will interfere with, or be detrimental to, the administration of optimal health care to the subject

Primary outcomes:
measure: Quality of Life
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cedar Knolls
country: United States
facility: New Neurons Neurosurgical Institute
state: New Jersey
Study officials:
References:
Clinical trial NCT03635229: Risk Factor of POD and POCD After Cardiac Surgery
Official title: Risk Factor of Postoperative Delirium and Postoperative Cognitive Decline After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Postoperative Delirium
Postoperative Cognitive Dysfunction
Keywords: cardiac surgery
perioperative care
postoperative delirium
postoperative cognitive dysfunction
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 360
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly patients (age 65 and older) undergoing cardiopulmonary bypass- assisted surgery with anticipated postoperative intensive care unit admission

Brief summary: Postoperative delirium (POD) and postoperative cognitive decline (POCD) are common after surgeries in the elderly, especially after cardiothoracic surgery. These conditions are associated with adverse short- and long-term outcomes.

Multiple conditions in the perioperative period have been proposed as risk factors of POD and POCD.

Incidences vary across institutions due to differences in screening and diagnostic tools.

Detailed description: This is a prospective observational study to identify the incidences and risk factors of postoperative delirium and postoperative cognitive decline after elderly patients undergoing cardiac surgical procedures which require cardiopulmonary bypass and postoperative intensive care unit (ICU) admission.

Patients will be screen for POD and POCD with various psychological tests in the postoperative period and after hospital discharge.

Perioperative data and outcomes will be used to identify risk factors of both conditions.

Eligibility criteria: Inclusion Criteria:

* age 65 years old or older
* undergoing open heart surgery (cardiopulmonary bypass assisted cardiothoracic surgery

Exclusion Criteria:

* unable to communicate
* severe visual or hearing impairment

Primary outcomes:
measure: Postoperative delirium
timeFrame: Postoperative day 1-5 (5 consecutive days)
Secondary outcomes:
measure: Postoperative cognitive dysfunction - postoperative
timeFrame: Postoperative day 5-9 (5 consecutive days)
measure: Postoperative cognitive dysfunction - 3 month
timeFrame: At 3rd month after hospital discharge
measure: Postoperative cognitive dysfunction - 1 year
timeFrame: At 12th month after hospital discharge
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
References:
Clinical trial NCT03221829: A Retrospective Analysis of Spinal Anaesthesia for TURBT Procedures in Elderly Patients
Official title: A Retrospective Analysis of Spinal Anaesthesia for Transurethral Resection of Bladder Tumour in Elderly Patients: A Single Centre Experience From 2007 to 2017
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Anaesthesia
Bladder Tumor
Transurethral Resection
Keywords: spinal anaesthesia
elderly patients
transurethral resection of bladder tumour
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2017-07-19
Enrollment: 2800
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients that have TURBT procedure under spinal anaesthesia in the Urology Departament (Medical University of Warsaw) 2007-2017

Brief summary: The aim of the study was to evaluate the safety and effectiveness of spinal anesthesia among elderly patients The basic methods for diagnosis and management of bladder cancer include endoscopic procedures (cystoscopy, trans-urethral resection of bladder tumour TURBT). The age of most patients is above 60, which increases the risk of complications during the perioperative period. Usually the leading anaesthesia method in TURBT procedures is regional, mainly spinal, anaesthesia. Although the prevalence of regional upon general anaesthesia is questioned, certain positive aspects of regional anaesthesia are indisputable. Maintaining logical communication with a patient during the procedure enables early diagnosis of complications (TUR syndrome, bladder perforation). Undeniably, regional anaesthesia ensures the best pain management in the early post-operative period. The simplicity of performing an efficacious spinal block and its cost-effectiveness are additional factors, which have contributed to the acknowledgement of the method as the standard of anaesthesia for transurethral procedures.


Eligibility criteria: Inclusion Criteria:

* TURBT procedure
* spinal anaesthesia
* age over 60

Exclusion Criteria:

* general anaesthesia

Primary outcomes:
measure: The effectiveness of spinal anaesthesia for TURBT evaluated by a number of participants that had the procedure done, without the need of conversion to general anaesthesia .
timeFrame: 6 months
Secondary outcomes:
measure: The influence of the bupivacaine spinal dose on bradycardia evaluated by a heart rate measurements
timeFrame: 6 months
measure: The influence of the bupivacaine dose on hypotension evaluated by the non-invasive blood pressure measurements
timeFrame: 6 months
measure: Experienced and non-experienced anesthetist does it influence the bupivacaine dose
timeFrame: 6 months
measure: Experienced and non-experienced anesthetist does it influence the spinal anaesthesia success
timeFrame: 6 months
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: I Department of Anaesthesiology and Intensive Care, Medical University of Warsaw
Study officials:
References:
Clinical trial NCT04277429: HFpEF and 2-year Mortality of COPD Patients
Official title: The Influence of hearT Failure With Preserved Ejection Fraction on 2year Mortality of Patients With cHronic obstructivE pulmonaRy disEaSE- THERESE Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease
Heart Failure
Lead sponsor: University Hospital Olomouc
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic obstructive pulmonary disease

Brief summary: This study was designed to assess potential relationship between heart failure with preserved ejection fraction and 2- year mortality of patients with chronic obstructive pulmonary disease


Eligibility criteria: Inclusion Criteria:

Exacerbation of chronic obstructive pulmonary disease requiring hospitalization

Age 40 - 80 years

Performance status 0-1 according to Eastern Cooperative Oncology Group (ECOG)

Long acting beta agonist (LABA)/ long acting antimuscarinic (LAMA) bronchodilator treatment

Exclusion Criteria:

Presence of major heart valve dysfunction

Documented noncompliance with treatment

Presence of active malignancy

Body mass index \> 40

Interstitial lung disease

Primary outcomes:
measure: Mortality
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Frýdek-Místek
country: Czechia
facility: Frydek Mistek Hospital
city: Olomouc
country: Czechia
facility: University Hospital Olomou
Study officials:
affiliation: Department of Respiratory Medicine
name: Milan Sova, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02081729: Assessment of VZV-specific ELISPOT Assay for Predicting VZV Infection in Kidney Transplant Recipients (AVE-KT)
Official title: Assessment of VZV-specific ELISPOT Assay for Predicting VZV Infection in Kidney Transplant Recipients (AVE-KT)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Kidney Transplantation
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Korea Advanced Institute of Science and Technology
First posted: 2014-03-07
Enrollment: 10
Sex: ALL
Minimum age (years): 16
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Kindeny transplant recipients

Brief summary: VZV is one of the important opportunistic infection in transplant recipients.Until now, there is no laboratory method to stratify the risk of VZV reactivation after solid organ transplantation. Theoretically, VZV-specific cell-mediate immune response before solid organ transplantation will further categorize the patients into high or low risk of VZV development after solid organ transplantation. The investigators thus evaluate the usefulness of VZV-specific ELISPOT assay in kidney transplant candidates to predict the development of VZV infection after kidney transplantation.

Detailed description: We will develop VZV-specific ELISPOT assay, then perform this assay before transplantation. We will evaluate whether this assay will predict zoster reactivation after transplantation.

Eligibility criteria: Inclusion Criteria:

* age 16 years or more
* agree with written informed consent
* WBC count 2000/uL or more

Exclusion Criteria:

* no exclusion criteria

Primary outcomes:
measure: zoster development
timeFrame: 6 months after transplantation
Secondary outcomes:
measure: mortality
timeFrame: 6 months after transplantation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Sung-Han Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06270329: Neuromuscular Training Program in Patients With Knee OA (Osteoarthritis)
Official title: Comparison of the Effectiveness of Neuromuscular Training Program and Conventional Physical Therapy Program in Patients With Knee Osteoarthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Neuromuscular training
Knee osteoarthritis
Physical therapy
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled clinical trial design
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare the effects of neuromuscular training program and conventional physical therapy program on pain, functional status, physical performance, balance, muscle strength and quality of life in patients with knee osteoarthritis (KOA).

Detailed description: The study was carried out in Afyonkarahisar Health Sciences University Health Application Research Center in individuals with 2nd or 3rd degree KOA according to Kellgren and Lawrence Classification. The study was planned as a randomized controlled clinical trial design. The study group were recruited to the neuromuscular training program and the control group were recruited to the conventional physical therapy program 5 days a week for 3 weeks. Individuals were evaluated at the baseline and after training programs. Demographic and clinical data were first recorded in the evaluation.

Eligibility criteria: Inclusion Criteria:

* Having grade 2 or 3 osteoarthritis according to the Kellgren and Lawrence Classification
* Having pain score of 2 or above on VAS
* Not having received physical therapy in the last 3 months
* Not having received an intra-articular corticosteroid injection in the last 6 months
* Not having used oral corticosteroids in the last month
* Being between the ages of 40-80
* Body mass index being between 19-40 kg/cm2

Exclusion Criteria:

* Systemic arthritis
* Hypertensive condition that prevents exercise
* Pregnancy, cognitive impairment, parkinson-like neurological disorders
* Having had a knee or hip joint replacement

Primary outcomes:
measure: Visual Analog Scale
timeFrame: At first and third week
measure: Western Ontario and McMasterUniversities Osteoarhritis Index
timeFrame: At first and third week
measure: Time on One Leg Standing
timeFrame: At first and third week
measure: Five Times Sit to Stand Test
timeFrame: At first and third week
measure: Manual Muscle Test
timeFrame: At first and third week
measure: Short Form
timeFrame: At first and third week
Secondary outcomes:
Other outcomes:
Locations:
city: Kütahya
country: Turkey
facility: Kutahya Health Science University
Study officials:
References:
Clinical trial NCT02427529: Muscle-Sparing Effect Of Human Chorionic Gonadotropin (hCG) During a Very Low Calorie Diet (VLCD)
Official title: Muscle-Sparing Effect Of Human Chorionic Gonadotropin (hCG) During a Very Low Calorie Diet (VLCD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: HCG
Keywords: hcg
Lead sponsor: Dr. Emma's Corporation
Sponsor class: OTHER
First posted: 2015-04-28
Enrollment: 59
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Subjects are female patients, randomized to HCG group or placebo group, during a prospective trial, in order to determine the significance, if any, of HCG on maintaining muscle mass during a very low calorie diet in order to demonstrate the potential significance of HCG administration on preserving lean body mass while losing weight.

Detailed description: Four-week clinical trials were conducted on 59 females between the ages of 20 and 55, over an 18 month period. Exclusion criteria included thyroid conditions or prior significant medical history. Patients were randomized to receive daily subcutaneous injections of either hCG (200-300IU) or saline (placebo). All were placed on a VLCD resembling a protein-sparing modified fast. The caloric intake was between 500 and 600 calories, with 50% protein and 50% complex carbohydrates consisting mostly of fruits and vegetables. Measured parameters: weight, body composition via bio-impedance, blood pressure, and blood labs. A subset also underwent weekly electrocardiograms (EKG).

Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) greater than 30,
* Female,
* good health

Exclusion Criteria:

* complex medical history,
* thyroid disease,
* BMI less than 30,
* psychological instability or history of eating disorder

Primary outcomes:
measure: Weight loss achieved during a trial of HCG vs. Placebo and a very low calorie diet.
timeFrame: 30 days
Secondary outcomes:
measure: Muscle loss comparison between HCG and placebo group during a very low calorie diet.
timeFrame: 30 days
Other outcomes:
measure: Fat loss comparison between HCG and placebo groups during a very low calorie diet.
timeFrame: 30 days
Locations:
city: Colts Neck
country: United States
facility: Dr. Emma's Corporation
state: New Jersey
Study officials:
References:
Clinical trial NCT03289429: Antiarrhythmic and Cardioprotective Effects of Atorvastatin Versus Magnesium Sulfate in Cardiac Valve Replacement Surgery
Official title: Comparative Study of the Antiarrhythmic and Cardioprotective Effects of Atorvastatin Versus Magnesium Sulfate in Cardiac Valve Replacement Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Arrhythmias
Keywords: Atorvastatin
Magnesium sulfate
POAF
Cardiac
Valve
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-09-21
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to compare the antiarrhythmic and cardioprotective effects of Atorvastatin versus Magnesium Sulfate after Cardiac valve Replacement Surgery

Detailed description: Arrhythmia is a common complication after cardiac valve surgery. Postoperative atrial fibrillation (POAF) is the most common type of arrhythmia after cardiac surgery. It has different leading causes, including myocardial injury, inadequate myocardial protection, the effect of cardiopulmonary bypass, and electrolyte imbalance. Beta blockers, amiodarone, and magnesium sulfate are used for the management of POAF.

Statin is used commonly for its lipid lowering action, however, some studies shows that statin has powerful pleiotropic effects including its antiarrhythmic effect.

This study aims to compare the antiarrhythmic and cardioprotective effects of Atorvastatin versus magnesium sulfate after cardiac replacement surgery.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing isolated valvular replacement surgery.
* Preoperative rhythm: Sinus rhythm.
* Preoperative troponin I \< 0.01 ng/mL.
* Normal lipid profile.
* White blood cells (4-11 X 103/mm3).
* Preoperative C-reactive protein \< 3 mg/L.

Exclusion Criteria:

* History of atrial fibrillation.
* Any degree of heart block or patients with implanted pacemaker.
* Prior use of Antiarrhythmic drugs.
* Preoperative lipid lowering therapy (e.g statins) during the last 3 months.
* Previous treatment with any type of magnesium containing supplementation (the week before the intervention).
* Underlying heart failure or Left ventricular ejection fraction \< 0.3.
* Previous myocardial infarction.
* Diabetes or other metabolic disorders.
* Renal diseases.
* Hepatic dysfunction.
* Underlying thyroid problems (hypo/hyperthyroidism).
* Underlying inflammatory disease (active or controlled)
* Immunosuppressive and anti-inflammatory medications for the treatment of coexisting conditions.
* Psychological disorders,
* Emergency cardiac surgery

Primary outcomes:
measure: Postoperative atrial fibrillation
timeFrame: Five days
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
Clinical trial NCT01416129: Southern Bone & Joint Study - Brimless Sockets
Official title: Biomechanical Superiority of Brimless Versus Ischial Ramus Containment (IRC) Sub Atmospheric Transfemoral Interfaces
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Socket Designs of Transfemoral Amputees.
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: Southern Bone & Joint Specialists, P.A.
First posted: 2011-08-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators are comparing a new type of prosthetic socket for above knee amputees to the standard of care. The hypothesis is that the new type of socket will show equivalence to the standard of care using our designated outcome measures.


Eligibility criteria: Inclusion Criteria:

* Unilateral transfemoral or knee-disarticulation amputee
* 18 to 85 years of age
* K3 (variable cadence and community) ambulators;
* Be able to independently provide informed consent
* Be willing to comply with study procedures.

Exclusion Criteria:

* History of chronic skin breakdown on the residual limb
* Conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking)
* Use of any assistive devices/walking aids, beyond a prosthesis, to ambulate
* Unwillingness/inability to follow instructions

Primary outcomes:
measure: Gait
timeFrame: Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.
measure: Balance and Stability
timeFrame: Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.
measure: Quality of Life
timeFrame: Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.
measure: Socket Pressure
timeFrame: 10 minutes after fitting with both sockets
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: Jason Highsmith, PT,DPT,CP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05613829: Frailty Index and Mortality After a Burn Surgery
Official title: Preoperative Frailty Index and 90-day Mortality After a Burn Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burns
Frailty
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Hangang Sacred Heart Hospital
First posted: 2022-11-14
Enrollment: 1118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged ≥ 18 years who were admitted to the burn ICU from 2012 to 2021.

Brief summary: Frailty is a condition of a reduced physiological reserve and is associated with postoperative morbidity and mortality. We evaluated the impact of preoperative frailty index (CFI) on 90-day mortality after a burn surgery.


Eligibility criteria: Inclusion Criteria:

* Patients with burn injuries were admitted to the burn ICU.

Exclusion Criteria:

* Patients with incomplete medical records were excluded.

Primary outcomes:
measure: Mortality
timeFrame: Postoperative 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan medical Center
Study officials:
affiliation: Hangang Sacred Heart Hospital
name: Young Joo Seo
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Young-Kug Kim
role: PRINCIPAL_INVESTIGATOR
References: