louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04469166: Effects of the Use of Tourniquet in Total Knee Arthroplasty on the Clinical and Functional Outcomes With 5 Years of Follow up
Official title: Effects of the Use of Tourniquet in Total Knee Arthroplasty on the Clinical and Functional Outcomes With 5 Years of Follow up: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Use of Tourniquet in Total Knee Arthroplasty
Keywords: Tourniquet
Total knee arthroplasty
Clinical outcomes
Functional outcomes
Lead sponsor: Hawler Medical University
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 101
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: This study is randomized controlled trial with 5 years follow up and involved 101 patients divided in two groups; group A in which tourniquet was used in total knee arthroplasty while group B in which tourniquet was not used. All these patients were analyzed for the clinical and functional outcome measures.

Detailed description: In this study, investigators have primary outcome measures and secondary outcome measures which were assessed in multiple periods to see the effects of using tourniquet in total knee arthroplasty on the clinical and functional outcomes with follow up of 5 years.

Eligibility criteria: Inclusion Criteria:

* Grade 3 and 4 osteoarthritis
* age 55-80 years
* patients agree to participate in the study

Exclusion Criteria:

* Smoking
* Diabetes mellitus .Symptomatic spinal pathology with moderate to severe cervical or lumbosacral spinal stenosis.
* Hip pathology like osteoarthritis or fractures
* Neuromuscular disorders
* Blood dyscrasia or anticoagulant treatment .Body mass index equal to 30 or more.
* Previous knee surgery or knee infection
* Peripheral vascular disease
* Rheumatoid arthritis
* Hemoglobin less than 12 gram/deciliter

Primary outcomes:
measure: Knee society score
timeFrame: This score was assessed at 5 years postoperatively
measure: Knee injury and osteoarthritis outcome scores
timeFrame: This score was assessed at 5 years post-operatively
measure: VAS for thigh pain
timeFrame: This score was assessed at 1st day post-operatively
Secondary outcomes:
measure: Post operative complications
timeFrame: These complications as bleeding, infection, Deep venous thrombosis and revision are assessed at postoperative period.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02261766: Evaluation of 5 Days Holter and 30 Days Thumb-ECG for Detection of Atrial Fibrillation in Stroke Patients
Official title: Detection of Atrial Fibrillation, -Evaluation of 5 Days Holter and 30 Days Thumb-ECG for Detection of Atrial Fibrillation in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Stroke
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2014-10-10
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will compare the two methods 5 days holtermonitoring and 30 days thumb electrocardiogram for detection of atrial fibrillation in stroke patients

Detailed description: Patients with a newly stroke will be examined with both 5 day holter monitoring and 30 days thumb ECG at the same time. The detection rates of the two methods will be compared

Eligibility criteria: Inclusion Criteria:

* stroke or TIA within the last 3 months verified by a CT or a MR scan or unequivocal symptoms and old infarcts visualised on CT or MR
* age 65 or above
* patients able to handle the thumb-ECG
* written informed consent

Exclusion Criteria:

* earlier diagnose of atrial fibrillation
* pacemaker or ICD device
* stroke induced by trauma, infection or surgery procedure
* carotid stenosis of more than 60%

Primary outcomes:
measure: Atrial fibrillation detection rate on Thumb-ECG
timeFrame: 1 month
Secondary outcomes:
measure: Atrial fibrillation detection rate on holtermonitoring
timeFrame: 5 days
measure: Time to detection of atrial fibrillation on holter
timeFrame: 5 days
measure: Time to detection af atrial fibrillation on thumb-ECG
timeFrame: 30 days
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Department of Neurology, Herlev Hospital
Study officials:
References:
citation: Poulsen MB, Binici Z, Dominguez H, Soja AM, Kruuse C, Hornnes AH, Rasmussen RS, Overgaard K. Performance of short ECG recordings twice daily to detect paroxysmal atrial fibrillation in stroke and transient ischemic attack patients. Int J Stroke. 2017 Feb;12(2):192-196. doi: 10.1177/1747493016669883. Epub 2016 Sep 30.
Clinical trial NCT06469866: Deep Neuromuscular Block Affect the Quality of Recovery After Laparoscopic Hysterectomy
Official title: Effect of Deep Neuromuscular Block on the Quality of Recovery After Laparoscopic Hysterectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neuromuscular Blockade
Laparoscopy
Keywords: Neuromuscular block
Recovery
Laparoscopic hysterectomy
Lead sponsor: Anqing Municipal Hospital
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 72
Sex: FEMALE
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: BACKGROUND: Some studies have revealed that deep neuromuscular block (NMB) improve surgical conditions and alleviated postoperative pain compared with moderate NMB. The present study investigated deep NMB could improve the quality of recovery after laparoscopic hysterectomy

METHODS: seventy-two women with elective laparoscopic hysterectomy were randomly divided into 2 groups: Patients in group A received low-pressure pneumoperitoneum (LPP), which was set at 8-10 mmHg with deep NMB. Patients in group B received standard-pressure pneumoperitoneum (SPP), which was set at 12-14 mmHg with moderate NMB. Primary outcome was the quality of recovery (QoR-15) at 1 day after sugery. The secondary outcomes included postoperative pain, surgical condition, incidence of shoulder pain, the incidence of rescue analgesic drug use, cumulative dose of analgesics, time of first flatus, post-operative nausea and vomiting, time of tracheal tube removal.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status Ⅰ- Ⅲ
* Scheduled for elective laparoscopic hysterectomy

Exclusion Criteria:

* Inability to give informed consent
* BMI \>35
* Renal or hepatic insufficiency
* History of preoperative psychiatric
* Previous surgery at procedure site
* Neuromuscular disease, pregnancy, and contraindications to study medications.

Primary outcomes:
measure: Quality of recovery
timeFrame: 1 day after operation
Secondary outcomes:
measure: Shoulder pain
timeFrame: The first 24 hours after operation
measure: Postoperative nausea and vomiting
timeFrame: The first 24 hours after operation
Other outcomes:
Locations:
city: Anqing
country: China
facility: Department of Anqing Munucipal Hospital Anesthesiology
state: Anhui
Study officials:
References:
Clinical trial NCT01290666: Study of GORE® BIO-A® Fistula Plug for Use in Anal Fistula Repair
Official title: Multicenter,Prospective, Observational Study of GORE® BIO-A® Fistula Plug for Use in Anal Fistula Repair
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Anal Fistula
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2011-02-07
Enrollment: 93
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: All patients presenting with anal fistulae that meet inclusion and exclusion criteria.

Brief summary: Primary outcome variable is healing at the final follow up visit.

Detailed description: The primary purpose of this prospective, multicenter, observational, single arm study is to further substantiate efficacy of the GORE® BIO-A® Fistula Plug when used as a soft tissue reinforcement of anal fistula repair and healing.

Eligibility criteria: Inclusion Criteria:

* Transsphincteric fistula consisting of 1 tract(defined as a fistula which would not be amenable to fistulotomy); determined during operative procedure
* Likely cryptoglandular origin
* Must be at least 18 years of age
* Patients informed about the study, and will have read, understood and signed the patient informed consent and authorization to use PHI data, as applicable
* Patients willing and able to submit to postoperative follow-up evaluations

Exclusion Criteria:

* Crohn's Disease
* Evidence of on-going local infection
* History of more than 2 prior definitive repair attempts; repair attempt is defined as any of the following: advancement flap, cutting seton, fistulotomy, fistulectomy, fibrin glue, anal fistula plug, LIFT
* Superficial fistulas without any muscle involvement
* Fistulae of traumatic origin, including obstetric
* Intersphincteric fistulas that would be candidate for fistulotomy
* Horseshoe or multi-tract fistulas
* Ano-vaginal or recto-vaginal fistulas
* Anastomotic fistulas (ileo-anal, colo-anal)
* A wound-healing or autoimmune disorder (including insulin-dependent diabetics)
* Subjects who are immunocompromised such as, with HIV, or currently receiving chemo or radiation therapy
* Subjects who are immunosuppressed, e.g. transplant patients, patients taking steroids, TNF agents, methotrexate
* History of prior or current pelvic radiation
* Difficulty comprehending or complying with the study (in surgeon's opinion)

Primary outcomes:
measure: Fistula Closure
timeFrame: 12 months post procedure
Secondary outcomes:
measure: Duration of Drainage Post Procedure
timeFrame: Follow up out to 12 months post procedure
Other outcomes:
Locations:
Study officials:
affiliation: University of California, Irvine
name: Michael J Stamos, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stamos MJ, Snyder M, Robb BW, Ky A, Singer M, Stewart DB, Sonoda T, Abcarian H. Prospective multicenter study of a synthetic bioabsorbable anal fistula plug to treat cryptoglandular transsphincteric anal fistulas. Dis Colon Rectum. 2015 Mar;58(3):344-51. doi: 10.1097/DCR.0000000000000288.
Clinical trial NCT00287066: A Clinical Trial Assessing the Impact of Inhaled Insulin on Glucose Disposition
Official title: Open-Label Randomized Two-Way Crossover Pilot Study To Estimate The Effects Of Inhaled Versus IV Infusion Of Human Insulin With Regards To Glucose Disposal In Subjects With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetes Mellitus
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-02-06
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To assess the impact of inhalation of insulin on glucose disposition in patients with type 1 diabetes

Detailed description: The study was terminated on Oct. 28, 2007. The protocol was undergoing implementation and methodological issues with major revisions that qualified this trial as a new trial. Pfizer decided to cancel new trials because of the decision to withdraw Exubera due to lack of market performance and not for safety reasons.

Eligibility criteria: Inclusion Criteria:

* Diabetes mellitus Type 1

Exclusion Criteria:

* Asthma, COPD
* Smoking

Primary outcomes:
measure: 18F-labeled glucose uptake in muscle
Secondary outcomes:
measure: Glucose turnover overnight Insulin pharmacokinetics
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05951166: Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension
Official title: Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Failure Patients With Pulmonary Hypertension
Lead sponsor: Gradient Denervation Technologies
Sponsor class: INDUSTRY
First posted: 2023-07-18
Enrollment: 5
Sex: ALL
Minimum age (years): 22
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A prospective, single arm, multi-center study designed to evaluate the safety, and feasibility of the Gradient Denervation System
Primary purpose: TREATMENT

Brief summary: Prospective, single-arm, multicenter First in Human study to characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Pulmonary Hypertension


Eligibility criteria: Inclusion Criteria:

* Heart Failure with EF ≥ 40% (by TTE within last 3 months)
* Mean Pulmonary Artery Pressure (mPAP) \>20 mmHg at rest
* Pulmonary Vascular Resistance (PVR) ≥ 3WU at rest
* Pulmonary Capillary Wedge Pressure \> 15 mmHg (at rest) or \> 18 with passive leg raise
* Cardiac index (CI) ≥ 1.7 L/min/m2
* NYHA Class II or III
* Glomerular Filtration Rate (GFR) ≥ 25 ml/min
* N-terminal pro-B-type natriuretic peptide (NT-proBNP) ≥ 400pg/mL
* Stable, guideline directed medical treatment, including controlled volume status for a minimum of 3 months prior treatment

Exclusion Criteria:

* Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel
* Pulmonary artery aneurysm, moderate or greater PA stenosis or other PA anatomy that would prevent safe or proper use of the study device
* Systemic infection or localized infection/rash at planned access site at time of procedure
* Myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the previous 3 months
* CRT or other Interventional cardiac procedure (except RHC) within last 3 months
* Any planned cardiac procedure or inpatient procedure within the next 30 days

Primary outcomes:
measure: Device related serious adverse events
timeFrame: 30 days post-treatment
Secondary outcomes:
measure: Mean change from baseline in Pulmonary Vascular Resistance (woods units)
timeFrame: 6- months post-treatment
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: Israeli-Georgian Medical Research Clinic Helsicore
city: Tbilisi
country: Georgia
facility: Tbilisi Heart Clinic
Study officials:
References:
Clinical trial NCT06807866: Duloxetine for Perioperative Pain in Hip Arthroplasty: A RCT
Official title: Use of Duloxetine for Perioperative Pain Control After Total Hip Arthroplasty: Randomized Controlled Clinical Trial (RCT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: THA
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary objective of this study is to compare total narcotic intake standardized via milligram morphine equivalents between duloxetine and placebo cohorts after a total hip arthroplasty.


Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years of age
* Patients undergoing primary total hip arthroplasty
* Ambulatory patient prior to fracture
* Subjects must be capable of providing informed consent
* English or Spanish speaking

Exclusion Criteria:

* Previous hemiarthroplasty or THA on ipsilateral hip
* History of Complex Regional Pain Syndrome in ipsilateral extremity
* History of demyelinating disorder or neurologic deficit that may contribute to altered pain tolerance or sensation
* Acute or chronic hip infection in ipsilateral extremity
* Pregnant or breastfeeding
* Open fracture
* Polytrauma
* Intravenous or drug users within 6 months of surgery
* Liver Failure via clinical diagnosis or international normalized ratio greater than 1.5 or partial thromboplastin time greater than 40
* Patients on selective serotonin reuptake inhibitor, serotonin norepinephrine reuptake inhibitor, monoamine oxidase inhibitor, and/or tricyclic anti-depressant
* Severe renal dysfunctions, such as glomerular filtration rate less than 30
* Moderate to severe depression as diagnosed by a clinician
* Taking cytochrome P450 1A2 inhibitors and cytochrome P450 1A6 inhibitors for the duration of 5 half-lives as these drugs are clinically eliminated within 5 half-lives
* History of uncontrolled narrow angle glaucoma

Primary outcomes:
measure: Total Milligram Morphine Equivalent (MME)
timeFrame: Up to 24 hours
Secondary outcomes:
measure: Change in Pain as measured by Visual Analog Scale (VAS)
timeFrame: Baseline, up to 24 hours, 3 months
measure: Musculoskeletal function as measured by SMFA questionnaire
timeFrame: Up to 3 months
measure: Hospital Length of stay measured in hours
timeFrame: Up to 96 hours
measure: Ambulation distance measured by meters
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Victor Hernandez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01713166: Effects of Colloid and Crystalloid on the Microcirculatory Alterations During Off-pump Coronary Artery Bypass Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgery
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-10-24
Enrollment: 120
Sex: ALL
Minimum age (years): 20
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 compare the effects of crystalloid and colloid, which are used for pump priming solution, on the microcirculatory alterations during cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* Off-pump Coronary Artery Bypass Surgery

Exclusion Criteria:

* Infection
* Postoperative use of steroid
* Liver cirrhosis, Child-Pugh C
* Renal disease on hemodialysis
* Patients who cannot receive vascular occlusion test (severe peripheral vascular disease, arteriovenous fistula, burn)
* EF \< 40% on the preoperative echocardiography
* Preoperative use of vasopressors or inotropic agents

Primary outcomes:
measure: Recovery slope
timeFrame: until 2 days after surgery
measure: syndecan-1
timeFrame: until 2 days after surgery
Secondary outcomes:
measure: lactate
timeFrame: until 2 days after surgery
measure: StO2 (tissue oxygen saturation)
timeFrame: until 2 days after surgery
measure: Cytokine
timeFrame: until 2 days after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT01172366: A Study to Evaluate the Potential for Interpersonal Transfer of Testosterone Following Single Dose Application
Official title: A Phase I Study to Evaluate the Potential for Interpersonal Transfer of Testosterone Following Single Dose Application of 2% Testosterone Metered Dose (MD) Lotion®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypogonadism
Keywords: Open label, single dose, pharmacokinetic study
Lead sponsor: Acrux DDS Pty Ltd
Sponsor class: INDUSTRY
First posted: 2010-07-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy male and female volunteers

Brief summary: The hypotheses for this study is that there is no transfer of testosterone from male (donor) subjects to female (recipient) subjects when contact is made 2 hours post application of 2% Testosterone MD-Lotion® if the donor has a covered application area with a T-shirt.


Eligibility criteria: Healthy Male Subjects:

Inclusion:

* Healthy male subjects aged ≥ 18 and ≤ 45, who have no history of clinically significant medical disorders and who have passed the required laboratory and physical screening tests.

Exclusion:

* Men with a history of allergy/sensitivity to testosterone or in whom testosterone therapy is contraindicated, or a clinically significant finding on physical exam or skin disorder.

Healthy Female Subjects:

Inclusion:

* Healthy premenopausal women aged ≥ 18 and ≤ 45, who have no history of clinically significant medical disorders and who have passed the required laboratory and physical screening tests.

Exclusion:

* Women with a history of allergy/sensitivity to testosterone or in whom testosterone therapy is contraindicated, or a clinically significant finding on physical exam or skin disorder.

Primary outcomes:
measure: Pharmacokinetics
timeFrame: 72 hours total
Secondary outcomes:
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: QPharm
state: Queensland
Study officials:
affiliation: Acrux DDS Pty Ltd
name: Tina Soulis, BSc, PhD
role: STUDY_DIRECTOR
References: