louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05581563: Clinical and Functional Outcomes of Tourniquet Use in Primary Total Knee Arthroplasty
Official title: Clinical and Functional Outcomes of Tourniquet Use in Primary Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Total Knee Arthroplasty
Lead sponsor: Mongi Slim Hospital
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Longitudinal Study Designs Cohort Study Simple randomisation with a 1:1 allocation ratio outcomes is measured after tourniquet use
Primary purpose: PREVENTION

Brief summary: Many surgeons choose to perform total knee arthroplasty (TKA) surgery with the aid of a tourniquet. A tourniquet is a device that fits around the leg and restricts blood flow to the limb. There is a need to understand whether tourniquets are safe, and if they benefit, or harm, patients. The aim of this study was to determine the benefits and harms of tourniquet use in TKA surgery

Detailed description: randomized controlled trials , comparing TKA with a tourniquet versus without a tourniquet. Outcomes included: post-operative pain measure with analogue visual scale function with Oxford Score , Lysholm score and International Knee Documentation Committee Score intraoperative blood loss measurement of quadriceps tonus in pre- and post-operative according to the international rating measurement of quadriceps area circumference duration of surgery, and length of hospital stay

Eligibility criteria: Inclusion Criteria:

* Osteoarthritis Kellgren and Lawrence score III or IV
* Written consent
* Total knee arthroplasty

Exclusion Criteria:

* Neurological dysfunction
* Coagulation disorder
* Glucocorticoids, aspirin, heparin, coumadine, warfarin
* History of pulmonary embolism

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: Baseline
measure: Visual Analogue Scale (VAS)
timeFrame: Day 1
measure: Visual Analogue Scale (VAS)
timeFrame: Day 2
measure: International Knee Documentation Committee 2000
timeFrame: Baseline
measure: International Knee Documentation Committee 2000
timeFrame: Month 3
measure: International Knee Documentation Committee 2000
timeFrame: Month 6
measure: Oxford Score (OS)
timeFrame: Baseline
measure: Oxford Score (OS)
timeFrame: Month 3
measure: Oxford Score (OS)
timeFrame: Month 6
measure: Lysholm score
timeFrame: Baseline
measure: Lysholm score
timeFrame: Month 3
measure: Lysholm score
timeFrame: Month 6
measure: perioperative blood loss
timeFrame: Hospital admission to discharge (about 3 days)
measure: quadriceps area circumference
timeFrame: Baseline
measure: quadriceps area circumference
timeFrame: Month 3
measure: quadriceps area circumference
timeFrame: Month 6
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05048563: Registry of Thiola EC Therapy
Official title: Open Label Prospective Observational Registry of Thiola EC Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystinuria
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2021-09-17
Enrollment: 25
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: Patients with cystinuria on Thiola EC.

Brief summary: Thiola EC represents several modifications of Thiola that promise better, more efficacious therapy of cystinuria. First, pill size has changed from 100 mg to 300 mg, meaning that typical pill burden will be reduced from, on average, 10 pills per day to 3-5 pills per day. This change will be welcomed by patients whose fluid intake and administration of potassium citrate are daily impositions. Second, the preparation is now enteric-coated, formulated to offer delayed release of active tiopronin. Lastly, Thiola EC can be taken with food which is an improvement to the inconvenient dosing regimen of Thiola, which can only be taken one hour before, or two hours after meals. These changes may affect compliance and side effect profiles compared to those of Thiola. In combination with potassium citrate or other alkali preparations, adverse GI effects are relatively common in actively-treated patients with cystinuria. It is possible that GI side effects may be reduced by Thiola EC.


Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older
2. Patients with cystinuria and a history of kidney stones
3. Taking Thiola EC
4. Willing and able to provide consent

Exclusion Criteria:

1. Unable to sign informed consent.

Primary outcomes:
measure: Wisconsin Stone Quality Of Life (WiSQoL) Score
timeFrame: Baseline
measure: Wisconsin Stone Quality Of Life (WiSQoL) Score
timeFrame: Month 6
measure: Wisconsin Stone Quality Of Life (WiSQoL) Score
timeFrame: Month 12
measure: Wisconsin Stone Quality Of Life (WiSQoL) Score
timeFrame: Month 18
measure: Wisconsin Stone Quality Of Life (WiSQoL) Score
timeFrame: Month 24
measure: Short Form-36 Health Survey (SF-36v2) Score
timeFrame: Baseline
measure: Short Form-36 Health Survey (SF-36v2) Score
timeFrame: Month 6
measure: Short Form-36 Health Survey (SF-36v2) Score
timeFrame: Month 12
measure: Short Form-36 Health Survey (SF-36v2) Score
timeFrame: Month 18
measure: Short Form-36 Health Survey (SF-36v2) Score
timeFrame: Month 24
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
Study officials:
affiliation: NYU Langone Health
name: David Goldfarb, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01242735: Exercise and Health Intervention for Patients With Obsessive Compulsive Disorder (OCD)
Official title: Testing the Efficacy of an Exercise Intervention for Patients With OCD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obsessive Compulsive Disorder
Keywords: Obsessive Compulsive Disorder
OCD
Exercise
Aerobic Exercise
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2010-11-17
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the effect of a moderate-intensity aerobic exercise intervention for Obsessive Compulsive Disorder (OCD) patients interested in reducing symptoms. The investigators expect that this project will contribute much needed knowledge about the role that aerobic exercise can play in managing the effects of OCD. If moderate-intensity aerobic exercise is efficacious in helping individuals with OCD manage obsessions and compulsions, this will establish that aerobic exercise may be a valuable adjunct to other OCD treatments such as medication and therapy.


Eligibility criteria: Inclusion Criteria:

1. are between 18 and 65 years of age
2. are sedentary, i.e. have not participated in regular aerobic physical exercise for at least 90 minutes per week during the past three months
3. currently engaged in at least 12 weeks of stable dose pharmacotherapy and/or are currently engaged in cognitive-behavioral therapy for the past 13 weeks
4. meet Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria for OCD as assessed by the Structured Clinical Interview for DSM Disorders, Patient Version (SCID-P)
5. have Y-BOCS score greater than 16

Exclusion Criteria:

1. DSM-IV diagnosis of substance abuse/dependence except for nicotine dependence
2. DSM-IV diagnosis of anorexia or bulimia nervosa
3. DSM-IV diagnosis of bipolar disorder
4. history of psychotic disorder or current psychotic symptoms
5. current suicidality or homicidality
6. marked organic impairment
7. physical or medical problems that would not allow for safe exercise participation
8. current pregnancy or intent to become pregnant during the next 12 weeks

Primary outcomes:
measure: Yale-Brown Obsessive Compulsive Scale (Y-BOCS; OCD symptomatology)
timeFrame: 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
affiliation: Butler Hospital
name: Ana M Abrantes, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05113563: Investigation of TEST (Transcranial Electric Stimulation Therapy) for Chronic Pain
Official title: Investigation of TEST (Transcranial Electric Stimulation Therapy) for Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2021-11-09
Enrollment: 6
Sex: ALL
Minimum age (years): 22
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The goal in this study is to investigate TEST (Transcranial Electric Stimulation Therapy) for chronic pain. It requires an inpatient stay on our research unit of about a month. The study is designed to address the cognitive and emotional aspects of chronic pain and other conditions that often accompany this disorder, such as major depression or drug use.

Detailed description: This project proposes to investigate the feasibility of TEST in subjects with chronic pain. This will be an open-label study where subjects (n=12) are administered 8-10 sessions of TEST over 4 weeks. Measurements of pain, mood, and memory will be obtained before and after the sessions. The hypothesis is that TEST will be feasible and tolerable in this population.

Eligibility criteria: Inclusion Criteria:

1. adults (ages 22 to 60) who understand all procedures and have the ability to provide informed consent, with a score on the Mini-Mental Status Exam of at least 24;
2. participants experiencing chronic pain, with ongoing pain symptoms, and score on the Brief Pain Inventory of \> 5 on question #3 (which asks about maximal pain in the past 24 hours) or \> 5 on question #5 (which asks about average pain in the past 24 hours);
3. a diagnosis of chronic postoperative pain, low back pain, musculoskeletal pain, fibromyalgia, visceral pain or neuropathic pain, including complex regional pain syndrome or peripheral neuropathy;
4. no significant changes in pain medications for at least one month prior to study entry.

Primary outcomes:
measure: Feasibility Will be Assessed by the Percent of Participants Who Complete
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: 1051 Riverside Drive
state: New York
Study officials:
References:
Clinical trial NCT03888963: Pulsed Radiofrequency for Chronic Mastalgia of Fibrocystic Disease of the Breast
Official title: for Patients With Fibrocystic Disease of the Breast, Does Pulsed Radiofrequency on Thoracic Paravertebral Nerve Reduce Pain Severity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-03-25
Enrollment: 10
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators will evaluate the analgesic efficacy of pulsed radiofrequency on the thoracic paravertebral nerves for patients with chronic mastalgia of fibrocystic disease of the breast


Eligibility criteria: Inclusion Criteria:

* patients with chronic mastalgia due to fibrocystic disease of the breast
* the pain duration maintained for more than 1 year
* the pain intensity is more than 5 on VAS pain score

Exclusion Criteria:

* coagulopathy
* infection at the site of the procedure

Primary outcomes:
measure: the changes in pain intensity measured by VAS pain score
timeFrame: patients will be evaluated at 3 months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Diab
Study officials:
References:
Clinical trial NCT00215735: Effect of Platelet Concentrate in Treatment of Diabetic Ulcers
Official title: Clinical Evaluation of the Safety and Effectiveness of Harvest Autologous Platelet Concentrate and Autologous Thrombin for Treatment of Lower Extremity Chronic Diabetic Ulcers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes
Keywords: diabetes
Ulcer
APC
Lead sponsor: Harvest Technologies
Sponsor class: INDUSTRY
First posted: 2005-09-22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Autologous platelet concentrate will enhance the rate of healing of chronic diabetic wounds

Detailed description: The treatment of a diabetic wound with APC and thrombinhas the potential to accelerate the re-epithial process when compared with usual care. The study is a prospective, randomized, blinded, multicenter clinical evaluation.

Eligibility criteria: Inclusion Criteria:chronic diabetic ulcer -

Exclusion Criteria:steroids, dialysis, vascular disease

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Washington Regional Medical Center
state: Alaska
city: Orlando
country: United States
facility: Lucerne Hospital
state: Florida
city: St. Petersburg
country: United States
facility: Bay Pines V.A. Medical Center
state: Florida
city: Boston
country: United States
facility: New England Medical Center Hospital
state: Massachusetts
city: Southfield
country: United States
facility: Traveling Medical Services
state: Michigan
city: Altoona
country: United States
facility: Blair Medical Associates
state: Pennsylvania
city: Providence
country: United States
facility: Roger Williams Hospital
state: Rhode Island
city: Madison
country: United States
facility: Tennessee Christian Hospital
state: Tennessee
city: Milwaukee
country: United States
facility: St. Luke's Medical Ctr
state: Wisconsin
Study officials:
affiliation: Tufts Medical Ctr
name: Mark Iafrati, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06173635: A Comparison Study of the Maxi Move 5 (MM5) Device
Official title: A Laboratory Trial to Explore the Benefits of the New Maxi Move 5 (MM5) Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Arjo AB
Sponsor class: INDUSTRY
Collaborators: name: Loughborough University
First posted: 2023-12-18
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This trial aims to evaluate the added improvements from a caregiver and patient benefit perspective.

The trial should identify the forces involved for the caregiver when manoeuvring the lift.


Eligibility criteria: Inclusion Criteria:

For expert patient:

* ≥18 years
* Healthy male or female
* 80-100 kg

  24 healthy volunteers (caregivers) will be recruited. They will require a strong working knowledge of passive floor lifts and patient positioning with the use of loop and clip slings.

Exclusion Criteria:

-

Primary outcomes:
measure: 1. Time to complete each transfer will be recorded
timeFrame: up to 24 months
measure: 2. A detailed hierarchical task analysis (HTA) of each activity will be completed using the video recordings and experimenter field notes for each transfer to asses the number of correct placements for each device.
timeFrame: up to 24 months
measure: 3. Physical load for movement of the hoist throughout the activities for each device will be measured.
timeFrame: up to 24 months
measure: 4 Collect subjective data from the caregivers that describe, comfort, ease of use, effort and willingness to adopt in practice, etc
timeFrame: up to 24 months
measure: 5 Subjective responses from the expert patient being transferred will be recorded
timeFrame: up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Loughborough
country: United Kingdom
facility: School of Design and Creative Art at Loughborough University
Study officials:
affiliation: Arjo AB
name: Karin Hannander
role: STUDY_DIRECTOR
References:
Clinical trial NCT03876535: Performance Evaluation of the Nanomix eLab® CRP, PCT, and LAC Assays With the Nanomix eLab System
Official title: A Performance Evaluation of the Nanomix eLab® C-Reactive Protein, Procalcitonin, and Lactate Assays With the Nanomix eLab System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
SIRS
Lead sponsor: Nanomix
Sponsor class: INDUSTRY
First posted: 2019-03-15
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Volunteers from medical wards presenting with acute illness, observation of infection and meeting SIRS criteria.

Brief summary: The performance of the eLab C-Reactive Protein, Procalcitonin, and Lactate Assays will be demonstrated during a method comparison study in which venous whole blood and plasma samples are used. eLab results will be compared to an FDA cleared predicate device. Demographic information will be collected for the subject. Venous blood will be collected in 2 Li-heparinized tubes (2-4ml per tube). One tube will be used for testing at the site and the second tube will be processed to plasma for storage and subsequent shipment to a designated testing site. Whole blood samples will be tested on the eLab C-Reactive Protein, Procalcitonin, and Lactate test as soon as possible after collection; testing on whole blood must be completed within 30 minutes of collection. A predicate Lactate test will also be run as soon as possible after collection; testing of WB on the predicate must be completed within 30 minutes of collection. Plasma will be separated from the whole blood via centrifugation within 30 minutes of collection and tested on the eLab C-Reactive Protein, Procalcitonin, and Lactate Assays and started on predicate CRP and PCT devices (If available at the site) within 30 minutes of the eLab whole blood test. The remainder of the plasma specimen and plasma from the second collection tube will be frozen within one hour of collection, then stored at approximately -20 degrees C or colder.


Eligibility criteria: Inclusion Criteria:

* Must be 18 years of age or older
* Must have provided written informed consent
* Admitted to ICU, Emergency Department or other medical wards for acute illness and observation of infection and meeting SIRS criteria (such as elevated heart rate, tachypnea, hypotension, fever, hypothermia, or elevated respiratory rate)

Exclusion Criteria:

* Pregnant or nursing
* Admitted to ICU after trauma
* Admitted to ICU after surgery
* Cardiogenic shock

Primary outcomes:
measure: Estimates of bias relative to an FDA cleared predicate device using CLSI EP9-A3 as a guideline.
timeFrame: One timepoint at enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF- San Francisco General Hospital
state: California
Study officials:
affiliation: Nanomix
name: Tina Landess
role: STUDY_DIRECTOR
References:
Clinical trial NCT03568435: Safety and Effectiveness of Nivolumab in Recurring Kidney Cancer Participants
Official title: Efficacy and Safety of Nivolumab in Metastatic Renal Cell Cancer Patients - Japanese Real-World Data Through Clinical Chart Review
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Cancer
Renal Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharma USA Inc
First posted: 2018-06-26
Enrollment: 212
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with RCC with distant metastasis treated with nivolumab under real clinical practice

Brief summary: A non-interventional, medical record review of clinical data collected from Japanese participants with recurring kidney cancer


Eligibility criteria: Inclusion Criteria:

* A patient with RCC with distant metastasis treated for the first time with nivolumab

Exclusion Criteria:

* Patients who have participated in some trials with immuno-checkpoint blockade before or after treatment with nivolumab after diagnosis with RCC

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Overall survival status
timeFrame: 6 months
measure: Overall survival status
timeFrame: 36 months
measure: Best overall response
timeFrame: 6 months
measure: Best overall response
timeFrame: 36 months
measure: Progression free survival rate
timeFrame: 6 months
measure: Progression free survival rate
timeFrame: 36 months
measure: Disease free survival
timeFrame: 6 months
measure: Disease free survival
timeFrame: 36 months
measure: Objective response rate
timeFrame: 6 months
measure: Objective response rate
timeFrame: 36 months
measure: Duration of response
timeFrame: 6 months
measure: Duration of response
timeFrame: 36 months
measure: Incidence of adverse events
timeFrame: 36 months
measure: Incidence of serious adverse events
timeFrame: 36 months
Secondary outcomes:
measure: Distribution of clinical characteristics
timeFrame: 36 months
measure: Distribution of socio-demographic characteristics
timeFrame: 36 months
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Local Institution - 0001
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: