louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06630988: Diagnostic and Management of Hand Infection.
Official title: Diagnostic and Management of Hand Infection: a Retrospective Cohort in a Tertiary Care Center.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hand Infections
Including Whitlows
Tendinous Infections
Septic Arthritis
Keywords: Hand infection
Whitlows
Tendinous infections
Septic arthritis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be selected from the data base of the hand emergency surgery department of our tertiary care center, based on a principal or secondary diagnosis of BJI appearing alone or in combination with either sepsis or a specific surgical procedure - 1400 potential patients.

Brief summary: Primary or secondary (post-traumatic infections, notably related to bites, wounds, etc.) infections of the hand are very common situations, even if the epidemiology is poorly understood. For example, hand bite injuries represent 1.2 million referrals to the healthcare system per year in the United States. Their nosological framework extends from simple infections of the skin and soft tissues such as whitlows, to potentially severe deep damage such as arthritis and osteitis, or phlegmons of the tendon sheaths. The diagnostic approach is not consensual, and the contribution of additional biological parameters (inflammatory syndrome) and morphological investigations (x-rays, ultrasound, CT-scan or MRI) is not codified. Microbiology seems dominated by Staphylococcus aureus, but few studies have precisely described the microbial etiology. Consequently, probabilistic antibiotic therapy and the need to take bacteriological samples for secondary adaptation are not standardized. Likewise, surgical strategies (abstention, systematic washing or depending on evolution) remain operator dependent. We consequently aim to described diagnostic, management and related outcomes or hand infections in a specialized tertiary care center.


Eligibility criteria: Inclusion Criteria:

* all patient ≥ 18
* yo followed-up for a hand infection in our tertiary care center
* from 01/01/2014 to 31/12/2023, including
* whitlows
* tendinous infections
* septic arthritis

Exclusion Criteria:

* osteomyelitis

Primary outcomes:
measure: Percentage of treatment failure during the management of hand infections.
timeFrame: between 01/01/2014 and 31/12/2023.
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: HCL - Hôpital Edouard Herriot
Study officials:
affiliation: Hospices Civils de Lyon
name: Florent Valour Pr Florent Valour, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02847988: Facilitating Functional Independence in Patients Receiving Prolonged Mechanical Ventilation
Official title: Facilitating Functional Independence in Patients Receiving Prolonged Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Muscle Weakness
Keywords: muscle strength
muscle function
functional status
Lead sponsor: RML Specialty Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2016-07-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of this proposal is to test the effectiveness of neuromuscular electrical stimulation (NMES) in improving functional status and muscle function in patients receiving prolonged mechanical ventilation.


Eligibility criteria: Inclusion Criteria:

* Duration of mechanical ventilation \>14 days
* Sufficiently awake
* Able to speak and comprehend English
* Willingness to participate

Exclusion Criteria:

* Cardiopulmonary Instability
* Acute-onset neuromuscular disease
* Lower-extremity amputee or paresis
* Open wound at electrode application points
* Pitting edema grade ≥3
* Presence of pacemaker, implanted defibrillator, or ventricular-assist device
* inability to transfer from sitting to standing before critical illness

Primary outcomes:
measure: Time to reach independence in performing functional activity
timeFrame: Hospital discharge, an expected average stay of 5 weeks
Secondary outcomes:
measure: The percentage of patients who can perform functional activities independently
timeFrame: Hospital discharge, an expected average stay of 5 weeks
Other outcomes:
Locations:
city: Hinsdale
country: United States
facility: RML Specialty Hospital
state: Illinois
Study officials:
affiliation: RML Specialty Hospital
name: Amal Jubran, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05358288: Effect of Bariatric Surgery on Physical Activity, Gait, Flexibility and Quality of Life
Official title: Investigation of the Effect of Bariatric Surgery on Physical Activity Levels, Spatiotemporal Parameters of Gait, Flexibility and Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Bariatric Surgery
Gait
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2022-05-03
Enrollment: 30
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: -Having obestity with BMI\>35 (indication for bariatric surgery)

Brief summary: This study aimed to analyze spatio-temporal characteristics of gait, physical activity level and changes in quality of life in patients by measuring conditions before bariatric surgery and third-month after the surgery.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of obesity
* Body mass index \> 35
* Speak and understand Turkish
* Ability of read and write

Exclusion Criteria:

* History of lower extremity surgery
* Musculoskeletal/systemic/neurological/psychiatric problems
* Urinary syndromes
* Limited gait due to cardio-pulmonary insufficiency
* Unwillingness to participate

Primary outcomes:
measure: Gait speed
timeFrame: Change from baseline at 3 months
Secondary outcomes:
measure: Support times
timeFrame: Change from baseline at 3 months
measure: Step Length
timeFrame: Change from baseline at 3 months
measure: Levels of physical activity
timeFrame: Change from baseline at 3 months
measure: Sit-Reach Test
timeFrame: Change from baseline at 3 months
measure: Modified Thomas Test
timeFrame: Change from baseline at 3 months
measure: Popliteal Angle
timeFrame: Change from baseline at 3 months
measure: Quality of Life
timeFrame: Change from baseline at 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02365688: Hemodynamic Response During Goal Directed Fluid Therapy in the OR
Official title: Correlation of Multiple Invasive and Non-Invasive Hemodynamic Monitored Modalities to Support Goal Directed Fluid Therapy During Open Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hemodynamic Instability
Keywords: Open Abdominal Surgical Procedure
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2015-02-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to retrospectively evaluate the hemodynamic response to goal directed fluid therapy fluid during open abdominal surgery where goal directed fluid therapy is a standard of care after establishing a pre-incision baseline response to fluids.

Detailed description: Electronic and annotated observation data to support an algorithm library

Eligibility criteria: Inclusion Criteria:

1. Adults ≥18 years booked for an open abdominal procedure
2. American Society of Anaesthesiologists (ASA) Physical Status 1 - 3
3. Expected duration of surgical procedure to be ≥ 2 hours
4. Standard of care monitoring to include cardiac output

Exclusion Criteria:

1. Open chest surgical procedure expected
2. Cardiac arrhythmia such as atrial fibrillation.
3. Right Ventricular Failure
4. Aortic regurgitation

Primary outcomes:
measure: Dynamic Hemodynamic Response to Fluid Resuscitation
timeFrame: Up to 6 hours but not to exceed duration of surgical procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: DUHS Department of Anestheiology
name: Timothy E Miller, MB ChB, FRCA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03591588: Effects of Diet Interventions on Monocytes in Metabolic Syndrome
Official title: Effects of Diet Interventions on Monocyte Phenotypes in Individuals With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Hypertriglyceridemia
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study includes 2 types of diets, i.e., high-saturated fat diet and low-fat high-protein diet, in the same individuals with randomized crossover design.
Primary purpose: BASIC_SCIENCE

Brief summary: Subjects with hypertriglyceridemia and metabolic syndrome are being recruited and receive diet interventions with either a high-saturated fat diet or a low-fat high protein diet for 4 days (days 1-4) and a breakfast on day 5. Blood samples are collected on day 1 and day 5 to examine lipid levels and circulating monocyte phenotypes.

Detailed description: Subjects with hypertriglyceridemia and metabolic syndrome are being recruited and receive diet interventions with either a high-saturated fat diet or a low-fat high protein diet for 4 days (days 1-4) and a breakfast on day 5. Blood samples are collected on day 1 at fasting state and on day 5 at fasting state and 4 and 6 hours after the breakfast to examine lipid levels and circulating monocyte phenotypes.

Eligibility criteria: Inclusion Criteria:

* Obese women and men with metabolic syndrome (MS)
* Fasting triglyceride (TG) equal to or greater than 150 mg/dl

Exclusion Criteria:

* \<21 years of age
* Perimenopausal, pregnant or breastfeeding women
* Current smokers
* Obvious inflammation or other acute illnesses
* Obesity due to endocrinologic disorders including polycystic ovary syndrome
* Partial lipodystrophy
* Diabetes requiring insulin or \>1 oral medication
* Fasting TG ≥650 mg/dl
* A history of pancreatitis
* Myocardial infarction within the past 3 years
* Any hospitalization within the past 2 months
* Takes steroids.

Primary outcomes:
measure: Effects of diet interventions on monocyte phenotypes
timeFrame: 2016 to 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Center for Prevention of cardiometabolic disease
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: HUAIZHU WU, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05155488: A Study to Improve the Awareness of Mucopolysaccharidosis Type II in Brazil
Official title: Mucopolysaccharidosis Type II in Brazil: A Retrospective Secondary Database Study (Informatics Department of Brazilian Health System - DATASUS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mucopolysaccharidosis (MPS)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-12-13
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants diagnosed with MPS II cases in Brazil.

Brief summary: The main aims of the study are to learn about the percentage of mucopolysaccharidosis type II (MPS II) in adults in Brazil as well as about the diagnosis process. No study medicines will be provided to participants in this study. The data available for participants diagnosed with MPS II in DATASUS (a database of the Informatics Department of Brazilian Health System) will be reviewed. No clinic visits will be required as part of participation in this study.


Eligibility criteria: Inclusion Criteria:

All MPS II cases of (International Classification of Diseases, 10th revision \[ICD-10\] E76.1) at any age reported in DATASUS from January 1st, 2008 to September 30th, 2020 will be included.

Exclusion Criteria:

MPS II cases reported outside this period will be excluded.

Primary outcomes:
measure: Number of Participants Diagnosed With MPS II
timeFrame: From January 1, 2008 to September 30, 2020
measure: Number of Participants with Comorbidities Associated with MPS II
timeFrame: From January 1, 2008 to September 30, 2020
measure: Age of MPS II Diagnosis
timeFrame: From January 1, 2008 to September 30, 2020
Secondary outcomes:
measure: Number of Health Care Professionals Who Diagnosed MPS II
timeFrame: From January 1, 2008 to September 30, 2020
measure: Number of Health Care Professionals Consulted
timeFrame: From January 1, 2008 to September 30, 2020
measure: Time to MPS II Diagnoses
timeFrame: From January 1, 2008 to September 30, 2020
measure: Time Between MPS Diagnosis II and Start of Treatment
timeFrame: From January 1, 2008 to September 30, 2020
measure: Number of Treatments Received Before and After MPS II Diagnosis
timeFrame: From January 1, 2008 to September 30, 2020
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Takeda Distribuidora Ltda
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03879707: Improving Sleep Quality After Total Joint Arthroplasty ( TJA)
Official title: Improving Sleep Quality After Total Joint Arthroplasty ( TJA)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Pain After TJA
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
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 the evaluate and improve sleep quality after Total joint replacement.

Detailed description: Patients in early stage after TKA tend to suffer from sleep problem. Sleep disturbances frequently occur in patients after surgery, and its occurrence is harmful for postoperative recovery. Many factors can affect the quality of sleep after a major surgery including anesthesia-type, narcotic use and discomfort due to pain or restricted leg movements. Pain directly leads to sleep disruption or even deprivation and, in turn, poor-quality sleep aggravates pain sensation. There seems to be a vicious circle: pain - poor-quality sleep - intensified pain - even poorer-quality sleep.

Presumably, if a patient suffers from catastrophizing, depression and anxiety , the result of TKA will be worse due to poor sleep.

Eligibility criteria: Inclusion criteria -Adults 18 years and older

Exclusion criteria -

1. No chronic pain
2. Patients underwent revision or bilateral surgery.
3. Patients underwent fracture.
4. Patients suffering from dementia / delirium
5. Patients on narcotics greater than 10mg hydrocodom before surgery
6. Not willing to participate

Primary outcomes:
measure: Effect of melatonin and magnesium on pain
timeFrame: 90 days
Secondary outcomes:
measure: Effect of melatonin on daily activities
timeFrame: 90 days
measure: Effect of melatonin on daily activities
timeFrame: 90 days
measure: Effect of melatonin on daily activities
timeFrame: 90 days
measure: Effect of melatonin on daily activities
timeFrame: 90 days
measure: Effect of melatonin on daily activities
timeFrame: 90 days
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Derek Amanatullah, M.D. PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05764707: Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Treatment in Spinal Surgery
Official title: Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Treatment in Spinal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lumbar; Injury
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Spinal surgeries are generally associated with intense pain in the postoperative period, especially for the initial few days. The aim of this study is to examine the effect of intraoperative intravenous acetaminophen in spine surgery on postoperative analgesic requirements, pain scores, patient satisfaction, and clinical recovery. Enrolled patients are randomized to receive either intravenous acetaminophen or placebo at the time of surgical closure. It is hypothesized that patients receiving intravenous acetaminophen will have improved pain scores, require less opiate medication, and have better patient satisfaction than those receiving placebo.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing 1-2 levels primary spine surgery ≥18 years old

Exclusion Criteria:

* Chronic opiate users
* More than 3 levels or revision spine surgery
* Liver disease patients include elevated LFT, hepatitis A, hepatitis B or hepatitis C, cirrhosis, fatty liver disease, and any other liver diseases caused by drugs, poisons, or alcohol(s)
* Allergy/hypersensitivity to acetaminophen
* Patients that have used acetaminophen during the 24 hours before their scheduled surgery

Subjects who were unable to communicate in English were further excluded because of their inability to complete the postoperative questionnaires

Primary outcomes:
measure: Worst pain score in the post-anesthesia care unit
timeFrame: Time of postoperative care unit discharge readiness, approximately 3 hours
Secondary outcomes:
measure: Postoperative pain scores
timeFrame: Postoperatively until 72 hours or discharge, approximately three days
measure: Intraoperative opioid consumption
timeFrame: Intraoperatively
measure: Postoperative opioid consumption in the post anesthesia care unit
timeFrame: Postoperatively until time of PACU discharge, approximately 3 hours.
measure: Postoperative opioid consumption after discharge from the postoperative care
timeFrame: Time of discharge from the postoperative care unit until discharge from the hospital, an average of two days
measure: Time to rescue analgesia
timeFrame: Postoperatively until discharge, an average of two days
measure: Patient satisfaction
timeFrame: Time of postoperative care unit discharge readiness, approximately 3 hours.
measure: Length of hospital stay
timeFrame: Postoperatively until discharge, an average of two days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT00408707: Local Infiltration Analgesia With Ropivacaine Versus Placebo in Bilateral Knee Arthroplasty
Official title: Local Infiltration Analgesia With Ropivacaine Versus Placebo in Bilateral Knee Arthroplasty: a Placebo Controlled, Randomized, Double-Blinded Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: local infiltration analgesia
postoperative pain
ropivacaine
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2006-12-07
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine whether local infiltration analgesia (LIA) with Ropivacaine and adrenaline is effective in the treatment of postoperative pain after total knee arthroplasty.

Detailed description: Total knee arthroplasty (TKA) is increasingly common in the treatment of osteoarthrosis. Despite aggressive analgesic regimes, TKA is associated with moderate to severe postoperative pain, delaying mobilization and hospital discharge. A relatively new method for controlling postoperative pain after TKA is local infiltration analgesia (LIA) which consists of local infiltration with Ropivacaine and adrenaline.3 studies haved showed promising results of LIA, but none have documented a superior analgesic effect versus placebo.Patients receiving bilateral knee arthroplasty are recruited to receive LIA and placebo infiltration.The aim of the study is to demonstrate an analgesic effect of LIA versus placebo.

Eligibility criteria: Inclusion Criteria:

* patients eligible for total knee arthroplasty
* must speak and understand Danish
* must be able to give oral and written consent

Exclusion Criteria:

* Alcohol or medicine abuse
* Treatment with opioids
* Allergy to local anaesthetics
* Severe obesity

Primary outcomes:
measure: Postoperative pain
Secondary outcomes:
measure: analgésia consumption
measure: time to discharge
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
affiliation: Hvidovre University Hospital
name: Lasse Andersen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andersen LO, Husted H, Otte KS, Kristensen BB, Kehlet H. High-volume infiltration analgesia in total knee arthroplasty: a randomized, double-blind, placebo-controlled trial. Acta Anaesthesiol Scand. 2008 Nov;52(10):1331-5. doi: 10.1111/j.1399-6576.2008.01777.x.
Clinical trial NCT00538109: An Open-Label, Multicenter, Expanded Access Study of Oral AMN 107 in Adult Patients With Imatinib (Glivec®/Gleevec®_ - Resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
Official title: An Open-Label, Multicenter, Expanded Access Study of Oral AMN 107 in Adult Patients With Imatinib (Glivec®/Gleevec®_ - Resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leukemia, Myeloid, Chronic
Keywords: CML in Blast Crisis
Accelerated Phase oe Chronic Phase
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2007-10-02
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An Open-Label, Multicenter, Expanded Access Study of Oral AMN 107 in Adult Patients with Imatinib (Glivec®/Gleevec®_ - Resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase


Eligibility criteria: Inclusion Criteria:

* Patients with Imatinib (Glivec/Gleevec) Resistant or Intolerant CML in Blast Crisis, Accelerated Phase or Chronic Phase

Primary outcomes:
measure: Effectiveness
timeFrame: overall
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: King Faisal Specialist Hospital & Research Center
name: Naeem Chaudhri, MD
role: PRINCIPAL_INVESTIGATOR
References: