louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05404191: Prediction Rules for Low Level Laser on Burn Wounds
Official title: DEVELOPMENT OF A CLINICAL PREDICTION RULES TO IDENTIFY EFFICACY OF LOW LEVEL LASER ON BURN WOUND HEALING
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Burn Wound
Clinical Prediction Rules
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 60 adult of both sexes will participate in this study selected from burn unit of AHMED ORABI hospital, Their ages range from 10 to 50 years, TBSA more than 15%, partial thickness burn depth.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether patients' age, total burned surface area, wound stage and wound depth determine wound healing response to low level laser therapy in burn patients

Detailed description: It will be hypothesized that

1. Age may significantly affect burn wound healing's response to low level laser therapy.
2. TBSA may significantly affect burn wound healing's response to low level laser therapy.
3. Depth of wound may significantly affect burn wound healing's response to low level laser therapy.
4. Wound healing stage may significantly affect burn wound healing's response to low level laser therapy. There will be only one intervention group. The duration of the study will be 6 weeks divided to 18 sessions (three sessions per week). Sixty patients (male and female) will be recruited from the burn units.

Low level laser therapy will be performed for 30 min 3 times per week for 8 weeks on the wound area.

Wound area was irradiated by a red 655 nm light, 150 mW, 2 J/cm2 at the bed of the wound.

Eligibility criteria: Inclusion Criteria:

* Partial thickness Burn wound depth.
* Age ranges from 20-50 years.
* TBSA more than 15%
* Sufficient understanding to perform the test

Exclusion Criteria:

* Diabetic patients.
* Burn wound with skin graft
* Infected wounds
* Patients receiving immunosuppressive drugs.
* Patients receiving irradiation or chemotherapy.
* Chronic circulatory diseases
* Severe associated injury with burn.
* Associated co-morbidities, such as neurological diseases, malnutrition, and other inﬂammatory and/or infectious diseases.

Primary outcomes:
measure: reduced wound surface area
timeFrame: maximum of 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo university
Study officials:
References:
Clinical trial NCT00111891: An Investigational Drug Study Evaluating a Novel Approach to Treat Dyslipidemia (0524A-032)
Official title: A Dose Ranging Study to Evaluate the Tolerability of MK0524 (Niacin (+) Laropiprant) and Its Effects on Niacin-Induced Acute Flushing in Lipid Clinic Patients and/or Normal Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dyslipidemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-05-27
Enrollment: 575
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 3-week trial in normal healthy or lipid clinic patients studying a novel approach to treating dyslipidemia.

Detailed description: The duration of treatment is 7 days.

Eligibility criteria: Inclusion Criteria:

* Males and females (ages 25-75)

Exclusion Criteria:

* A condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participating in the study

Primary outcomes:
measure: Acute cutaneous symptoms induced by niacin for 7 days.
timeFrame: 7 days
Secondary outcomes:
measure: Tolerability
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05142891: Renal Tolerance of Amoxicillin and Cloxacillin Combination
Official title: Incidence of Actue Kidney Injury in Patients Treated With Amoxicillin and Cloxacillin Combination Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endocarditis
Acute Kidney Injury
Keywords: Endocarditis
Acute kidney injury
Amoxicillin
Cloxacillin
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient hospitalized at the Strasbourg University Hospital and treated concomitantly with Amoxicillin IV and Cloxacillin IV for ≥48 hours between January 1, 2016 and December 31, 2020.

Brief summary: 2015 European Society of Cardiology Guidelines have proposed the combination of Ampicillin and Cloxacillin for initial empirical treatment of infective endocarditis in acute severely ill patients (before pathogen identiﬁcation). Yet this combination has never been studied in clinical trials. High dose penicillin treatments are associated with a risk of nephrotoxicity.

The investigator's primary purpose is to describe patients treated with high dose Amoxicillin and Cloxacillin combination and to evaluate its renal tolerance.


Eligibility criteria: Inclusion criteria:

* Adult patient (≥18 years old)
* Hospitalized at the Strasbourg University Hospital and treated concomitantly with Amoxicillin IV and Cloxacillin IV for ≥48 hours between January 1, 2016 and December 31, 2020.
* Patient not having expressed his opposition, after information, to the reuse of his data for scientific research purposes.

Exclusion criteria:

* Subject having expressed opposition to participating in the study
* Subject under guardianship, curatorship or safeguard of justice

Primary outcomes:
measure: Description of patients treated with dual IV therapy combining cloxacillin and amoxicillin in high doses at Strasbourg University Hospital
timeFrame: Files analysed retrospectively from January 01, 2016 to December 31, 2020 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de maladies infectieuses et tropicales - Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Service de maladies infectieuses et tropicales - Hôpitaux Universitaires de Strasbourg
name: Yvon RUCH, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01367691: Cardiac MR (CMR) in Cardiac Resynchronization Therapy Non-responders
Official title: Cardiac MR (CMR) in Cardiac Resynchronization Therapy (CRT) Non-responders: Therapy Optimization by Means of Tissue Characterization, Hemodynamic Analysis and Analysis of Myocardial Activation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Keywords: CRT
heart failure
CMR
safety
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2011-06-07
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cardiac MR (CMR) will be used to assess myocardial activation and hemodynamics in patients with CRT.

Goals are to demonstrate that

* differences in Left ventricle (LV)- right ventricle (RV) pacing delays cause differences in myocardial activation
* differences in LV-RV pacing delays cause differences in LV/RV hemodynamics

and to use these data to optimize CRT.

Detailed description: CMR will be performed in patients under CRT who are currently not responding to CRT. Different LV-RV delays will be programmed during CMR and LV function and different dyssynchrony parameters will be assessed. Results will be used to determine the optimal LV-RV delay, and CRT-devices will be reprogrammed accordingly. Improvement in NYHA-class/conversion to therapy responder will be determined clinically after 3 months.

Eligibility criteria: Inclusion Criteria:

* presence of CRT device
* CRT non responder

Exclusion Criteria:

* pregnancy
* end-stage renal failure

Primary outcomes:
measure: improvement in NYHA-class
timeFrame: 6 months
Secondary outcomes:
measure: safety of CMR in CRT-patients
timeFrame: 6 months
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University Hospital, University of Bonn
state: NRW
Study officials:
References:
Clinical trial NCT02932891: An Open Label, Safety Study to Assess the Potential for Adrenal Suppression.
Official title: An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS Topical Product in Patients With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2016-10-13
Enrollment: 28
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Treatment with DSXS in Patients with Atopic Dermatitis

Detailed description: To evaluate the potential of DSXS topical product to suppress HPA axis function in patients with moderate to severe atopic dermatitis.

Eligibility criteria: Inclusion Criteria:

* Parent/legal guardian has signed informed consent form, which meets all criteria of current FDA regulations.

Exclusion Criteria:

* Females who are pregnant, nursing, planning to become pregnant during the duration of the study, or if of child-bearing potential and sexually active and not prepared to use appropriate contraceptive methods to avoid pregnancy

Primary outcomes:
measure: The Number of Patients in the Study With HPA Axis Suppression
timeFrame: 29 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Hawthorne
country: United States
facility: Taro Pharmaceuticals USA Inc.
state: New York
Study officials:
affiliation: http://www.novumprs.com/contact
name: Novum Pharmaceutical Research Services
role: STUDY_CHAIR
References:
Clinical trial NCT01929291: Post-marketing Surveillance to Assess the Safety of Boostrix Vaccine Given According to Prescribing Information in Korea
Official title: Assessment of Safety of GlaxoSmithKline (GSK) Biologicals' Combined Reduced Antigen Content Diphtheria-tetanus Toxoids and Acellular Pertussis Vaccine (dTPa), Boostrix When Administered According to the Approved Prescribing Information in Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diphtheria-Tetanus-acellular Pertussis Vaccines
Keywords: Korea
Post-marketing surveillance
Boostrix
Prescribing information
Safety
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-08-27
Enrollment: 682
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pre-adolescents, adolescents adults and elderly who receive Boostrix as a part of routine practice at a private clinic or hospital.

Brief summary: The purpose of this study is to collect safety information from pre-adolescents, adolescents and adults after Boostrix vaccination is administered according to the approved prescribing information in Korea.

Detailed description: Protocol amendment 3 rationale was as follows:

* Age for analysis set is specified.
* Subjects with pregnancy will be analyzed by their pregnancy status before/after vaccination.
* Pregnancy notifications must be done within 2 weeks

Eligibility criteria: Inclusion Criteria:

* Written or signed informed consent obtained from the subject/ subject's parent(s)/Legally Acceptable Representative(s) of the child. Korean male or female subjects who were recently vaccinated or eligible to receive Boostrix according to the locally approved Prescribing Information.

Exclusion Criteria:

* Those who are not eligible for vaccination according to the local Prescribing Information.
* Child in care.

Primary outcomes:
measure: Number of Unexpected Adverse Events (AEs)
timeFrame: During the 30-day (Day 0 - Day 29) follow-up period after vaccination.
measure: Number of Expected AEs.
timeFrame: During the 30-day (Day 0 - Day 29) follow-up period after vaccination.
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the 30-day (Day 0 - Day 29) follow-up period after vaccination.
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon-si
country: Korea, Republic of
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Park HJ, Kim SJ, Song R, Chen J, Kim JH, Devadiga R, Kang HC. A 6-year Prospective, Observational, Multi-Center Post-Marketing Surveillance of the Safety of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis (Tdap) Vaccine in Korea. J Korean Med Sci. 2019 Mar 22;34(12):e105. doi: 10.3346/jkms.2019.34.e105. eCollection 2019 Apr 1.
Clinical trial NCT03668691: Clinical Outcomes of Joint Arthroplasty
Official title: Clinical Outcomes of Joint Arthroplasty
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Osteoarthritis, Knee
Keywords: osteoarthritis
medial unicompartmental
lateral unicompartmental
bicompartmental
patellofemoral
Lead sponsor: St. Helena Hospital Coon Joint Replacement Institute
Sponsor class: OTHER
Collaborators: name: Stryker Orthopaedics
First posted: 2018-09-12
Enrollment: 250
Sex: ALL
Minimum age (years): 21
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 over 21 years of age who require a primary robotic-arm assisted partial knee replacement.

Brief summary: The purpose of this study is to document the clinical outcomes of partial knee replacement surgery using robotic-arm assisted knee joint surgery at 3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, 2 years, 5 years and 10 years post operative.

Detailed description: The purpose of this study is to document the clinical outcomes of partial knee replacement surgery using robotic-arm assisted knee joint surgery at 3 weeks, 6 weeks, 12 weeks, 6 months, 1 year, 2 years, 5 years and 10 years post operative.

Eligibility criteria: Inclusion Criteria:

* All patients over 21 years of age who require a primary robotic-arm assisted unicompartmental knee arthroplasty or bicompartmental knee arthroplasty. These patients will have failed non-operative management of their joint disease and are candidates for partial joint replacement because of pain and stiffness that interferes with their performances or normal daily activities.

Exclusion Criteria:

* Patient had an active infection
* Onlay implants were implanted without bone cement
* Patient does not have enough bone stock to allow for insertion and fixation of the components
* Patient does not have sufficient soft tissue integrity to allow for stability
* Patient has a neurological or muscular deformity that did not allow for control of the knee
* Patient will be excluded from participation in the study if they are cognitively unable to answer study questions
* Pregnant women are excluded.

Primary outcomes:
measure: % of patients with Revisions
timeFrame: 10 years after surgery
Secondary outcomes:
measure: Patient satisfaction rate
timeFrame: 10 years after surgery
Other outcomes:
Locations:
city: Saint Helena
country: United States
facility: St. Helena Hospital Coon Joint Replacement Institute
state: California
Study officials:
affiliation: St. Helena Hospital Coon Joint Replacement Institute
name: Thomas Coon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01678391: Feasibility of Endoscopic Ultrasound Based Biliary Stone Removal Without Fluoroscopy
Official title: Feasibility of Endoscopic Ultrasound Based Biliary Stone Removal Without Fluoroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Common Bile Duct Gall Stones
Lead sponsor: California Pacific Medical Center Research Institute
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: Northwestern University
First posted: 2012-09-05
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the feasibility and success of endoscopic ultrasound (EUS) directed biliary stone removal without use of fluoroscopy. Success for this study will be defined as the successful removal of all stones from the bile duct without the use of fluoroscopy. Fluoroscopy will only be used at the end of a presumed successful procedure to confirm that all stones are removed.


Eligibility criteria: Inclusion Criteria:

* Patients able to give informed consent
* Patients referred to IES for the endoscopic evaluation and treatment of suspected bile duct stones

Exclusion Criteria:

* Patients with \>3 bile duct stones or with any stone \>12mm on EUS
* Patients with no bile duct stones on EUS
* Patients with altered biliary anatomy (periampullary diverticulum, anomalous pancreatibiliary junction, altered surgical anatomy)
* Patients who are pregnant or breast-feeding

Primary outcomes:
measure: Successful removal of all stones from the bile duct without the use of fluoroscopy.
timeFrame: Up to 24 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
Study officials:
affiliation: California Pacific Medical Center
name: Janak Shah, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carr-Locke DL. Overview of the role of ERCP in the management of diseases of the biliary tract and the pancreas. Gastrointest Endosc. 2002 Dec;56(6 Suppl):S157-60. doi: 10.1067/mge.2002.129023. No abstract available.
citation: Shelton J, Linder JD, Rivera-Alsina ME, Tarnasky PR. Commitment, confirmation, and clearance: new techniques for nonradiation ERCP during pregnancy (with videos). Gastrointest Endosc. 2008 Feb;67(2):364-8. doi: 10.1016/j.gie.2007.09.036.
citation: Menees S, Elta G. Endoscopic retrograde cholangiopancreatography during pregnancy. Gastrointest Endosc Clin N Am. 2006 Jan;16(1):41-57. doi: 10.1016/j.giec.2006.01.004.
citation: Shah JN, Bhat YM, Hamerski CM, Kane SD, Binmoeller KF. Feasibility of nonradiation EUS-based ERCP in patients with uncomplicated choledocholithiasis (with video). Gastrointest Endosc. 2016 Nov;84(5):764-769. doi: 10.1016/j.gie.2016.03.1485. Epub 2016 Mar 31.
Clinical trial NCT03373591: Liposomal Bupivacaine in Bariatric Surgery
Official title: Randomized Controlled Trial Investigating Use of Liposomal Bupivacaine in Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bariatric Surgery Analgesia
Keywords: bariatric surgery
liposomal bupivacaine
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2017-12-14
Enrollment: 219
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 aim of this study is to perform a randomized controlled trial for patients undergoing bariatric surgery, comparing the need for opiates with and without administration of a transversus abdominis plane (TAP) block using the long acting local anesthetic, liposomal bupivacaine (Exparel®). From this study, the investigators will assess whether use of long acting local anesthetic can reduce the need for opiates in the bariatric population.

Detailed description: A prospective randomized controlled trial investigating the use of long acting local anesthetic for transversus abdominis block in patients undergoing bariatric surgery at Montefiore Medical Center. Patients will be randomized to either receive an intraoperative TAP block with LB, an intraoperative TAP block with RB, or no TAP block. All participants will receive standard post-operative analgesia regimen. Pain scores will be recorded by the nursing staff as reported by the patients for 24-36 hours post surgery. Patients will be monitored for secondary post-operative complications up to the 2-week mark following intervention.

Eligibility criteria: Inclusion Criteria:

* Obese patients undergoing bariatric surgery (LSG or LRYGB)
* Patients 18 years of age and older
* Surgical treatment between 01/01/2018 and 12/31/2018 over a 1 year period

Exclusion Criteria:

* Patients under the age of 18 years old
* Patients taking any opiates within 30 days of enrollment in the trial
* Patients with a history of chronic pain.
* Patients taking pregabalin or gabapentin.
* ASA IV
* Prior laparotomy
* Body Mass Index ≥ 60 kg/m2
* History of cardiac arrhythmia
* History of Seizure
* Psychiatric Diagnosis currently on antipsychotic medication

Primary outcomes:
measure: Fentanyl PCA mcg
timeFrame: 24 hours post surgery.
measure: Total Fentanyl Usage
timeFrame: During hospitalization, up to 7 days.
Secondary outcomes:
measure: Acetaminophen Usage
timeFrame: During hospitalization, up t 7 days.
measure: NSAID Usage
timeFrame: During hospitalization, up to 7 days.
measure: Pain Score
timeFrame: 24 hours post surgery.
measure: Length of Stay
timeFrame: Assessed every 24 hours post surgery, up to 168 hour post-surgery.
measure: Nausea
timeFrame: 24 hours post surgery.
measure: Time to Ambulation
timeFrame: Assessed every 24 hours post surgery, up to 168 hour post-surgery.
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
References: