louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06592547: Intravenous Metoprolol in Septic Shock
Official title: EFFECT of INTRAVENOUS METOPROLOL TARTRATE on MORTALITY in PATIENTS with SEPTIC SHOCK DUE to VENTILATOR-ASSOCIATED PNEUMONIA Thesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Septic Shock
Ventilator Acquired Pneumonia
Keywords: Beta blockers
septic shock
Rate control
mortality
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 100
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: A RCT designed to assess the effect of giving intravenous beta-blockers in patients with septic shock after achieving hemodynamic stability. The principle of this study is to control heart rate allowing for better diastolic filling and thus better perfusion.

Detailed description: A RCT, conducted at alexandria main university hospital, patients were divided into 2 groups, Control group which received the standard care for septic shock and metoprolol group which recieved intravenous metoprolol then patients were assessed for Blood pressure, heart rate, iv fluids needed, vasopressor doses and 28 days mortality

Eligibility criteria: Inclusion Criteria:

* The study population included adult patients (≥ 18 years) diagnosed with septic shock secondary to VAP with sinus tachycardia, from April 1, 2022, to April 31, 2023. Septic shock was defined according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). VAP was identified as per the guidelines provided by the American Thoracic Society and Infectious Diseases Society of America.

Exclusion Criteria:

* Patients were excluded if they had contraindications to beta-blockers, had a history of heart failure, or had been receiving beta-blockers prior to the septic shock. Patients were also excluded if they developed complications from beta- blockers administration.

Primary outcomes:
measure: 28-day Mortality
timeFrame: 28 days
Secondary outcomes:
measure: ICU stay
timeFrame: 28 days
measure: ventilator days
timeFrame: 28 days
measure: iv fluids
timeFrame: 28 days
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Main university hospital
Study officials:
References:
Clinical trial NCT00032747: Safety Study of Vasopressin V2 Receptor Antagonist on Patients With Severe Chronic Heart Failure (AQUAVIT).
Official title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Effects of Vasopressin V2 Receptor Antagonist on Clinical Improvement in Patients With Severe Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Heart Failure
Keywords: Chronic Heart Failure
Heart Disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2002-04-01
Enrollment: 338
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled, parallel-group forced up-titration study. Randomization will be stratified according to the patient's baseline serum sodium concentration (137-144 and \<137 mmol/L). The dose of study drug will be increased to the next level on Day 15, and the total duration of the double-blind treatment period is 120 days.


Eligibility criteria: * Men or women with chronic heart failure (NYHA Class IIIB and IV).
* Women must be post-menopausal or surgically sterilized; they cannot be pregnant or nursing.
* Age 21 to 80 years.
* Chronic heart failure of at least 3 months duration. For 2 months prior to screening, patients must have had symptoms at rest or on minimal exertion for more than 50% of the time. For 2 weeks prior to screening, patients must have had symptoms at rest or on minimal exertion for more than 90% of the time.
* Patients must be receiving a diuretic and an ACE inhibitor (or an angiotensin II receptor antagonist) for the treatment of heart failure.
* Patients may be receiving digoxin, a beta-blocker or spironolactone

Primary outcomes:
measure: Clinical status at day 120.
Secondary outcomes:
measure: NYHA functional class, left ventricular ejection fraction, global assessment,serum sodium concentration.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa Hospital and Clinics
state: Iowa
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Lincoln
country: United States
facility: Brian LGH Heart Institute
state: Nebraska
city: Cincinnati
country: United States
facility: The Lindner Clinical Trial Center
state: Ohio
city: Charleston
country: United States
facility: MUSC/Division Cardiology
state: South Carolina
city: Laval
country: Canada
facility: Sanofi-aventis Administrative Office
city: Guildford Surrey
country: United Kingdom
facility: Sanofi-aventis Administrative Office
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01033747: Safety and Efficacy of Deferasirox in Patients With Transfusion Dependent Iron Overload - a Non-comparative Extension Study
Official title: A 5-year Open Label, Non-comparative Extension to a Randomized, Open-label, Phase IIa Study to Evaluate Safety, Tolerability and the Effects on Liver Iron Concentration of Repeated Doses of 10 and 20 mg/kg/Day of Deferasirox in Comparison With 40 mg/kg/Day Deferoxamine in Patients With Transfusion-dependent Iron Overload
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Liver Iron Overload
Keywords: iron overload
iron chelation therapy
B-thalassemia
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-12-16
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and the effects on liver iron of Deferasirox when given for a long treatment period in patients with transfusion dependent iron overload.


Eligibility criteria: Inclusion Criteria:

* Patients Currently participating in the 9-month comparative prolongation of extension phase of the original study.
* Patients currently participating in the food-effect sub-study, according to amendment 3.
* Ability to provide written informed consent prior to participation in this non-comparative extension study.
* Female patients sexually active must use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation.
* Body weight of at least 35 kg.

Exclusion Criteria:

* Pregnant or breastfeeding patients.
* History of non-compliance to medical regimens and patients who are considered potentially unreliable.
* Proteinuria \> 300 mg/L second void morning urine.
* Patients with serum creatinine above the upper limit normal.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: The Relative Change From Baseline in Liver Iron Content (LIC) After Prolonged Use of Deferasirox
timeFrame: Baseline to 7 Years
Secondary outcomes:
measure: Relative Change in Serum Ferritin From Baseline to 3.5 Years
timeFrame: Baseline to 3.5 years
Other outcomes:
Locations:
city: Cagliari
country: Italy
facility: Novartis Investigative Site
city: Genova
country: Italy
facility: Novartis Investigative Site
city: Milan
country: Italy
facility: Novartis Investigative Site
city: Torino
country: Italy
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02348047: (S5-SAMU) Randomized Study Comparing the ASV (Adaptative Support Ventilation) to Conventional Ventilation
Official title: Randomized Study Comparing the ASV to Conventional Ventilation for Intubated Patients During Inter-hospital Transfers. Controlled Randomized Monocentric Prospective Study Comparing ASV Versus Conventional Ventilation Modes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Respiratory Distress Syndrome
Lead sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de Nice
First posted: 2015-01-28
Enrollment: 27
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: Compare ventilation parameters in Adaptative Support Ventilation mode to conventional mode, on intubated, ventilated and sedated patients, during their secondary transfer from an hospital to another, by a SMUR team.


Eligibility criteria: Inclusion Criteria:

* Intubation
* Secondary transfer (interhospital)
* Informed patients / close relations, signed consent

Exclusion Criteria:

* Primary transport of a ventilated, intubated, sedated patient
* Patient in limitation and stop of active therapeutics, dying person
* Broncho pleural fistula
* Patient under ECMO
* Patient included in another research submitted to consent
* Supervision, loss of liberty
* Pregnant woman

Primary outcomes:
measure: Ventilation parameter: VT
timeFrame: Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"
measure: Ventilation parameter: respiratory rate
timeFrame: Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"
measure: Ventilation parameters: Fi02
timeFrame: Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"
measure: Ventilation parameter: PEEP
timeFrame: Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"
measure: Ventilation parameter: ETC02
timeFrame: Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"
Secondary outcomes:
measure: Numbers of manual adjustments
timeFrame: Participants are followed during their inter hospital transfer,an expected average of 1 or 2 hours"
Other outcomes:
Locations:
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer, Service d'infectiologie
Study officials:
affiliation: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
name: Marilyne ROTI BOUNY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06496698: Impact of Suture Technique on Wound Healing in Ankle Fracture Surgery: A Randomized Controlled Trial
Official title: Impact of Suture Technique on Wound Healing in Ankle Fracture Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ankle Fractures
Lead sponsor: University of Puerto Rico
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our primary aim is to compare the complication rates of patients with ankle fractures who underwent skin closure using a running subcuticular suture pattern compared to an interrupted suture pattern. At the time of the operation, participants will be assigned to either the Subcuticular Suture Group (SSG) or the Simple Interrupted Suture Group (SISG) using computer-generated randomization programs. The surgeon will perform the assigned closure technique using standardized techniques. Running subcuticular Vicryl 3-0 sutures will be placed on patients in the experimental group while simple interrupted Monocryl 3-0 sutures patients in our control group.

Patients will be followed up at the two-week and eight-week postoperative mark where we will use the Patient and Observer Scar Assessment Scale (POSAS) to evaluate and compare wound healing. Additionally, photographs of the scars will be captured to visually assess the healing progression.


Eligibility criteria: Inclusion Criteria:

* Patients aged 21 years or older with isolated ankle fractures requiring surgical intervention and who consent to participate.

Exclusion Criteria:

* Patients that will be excluded from this study include those with complex ankle fractures, open fractures, a history of wound healing disorders, and/or those unable to provide consent.

Primary outcomes:
measure: Postoperative Complication rates
timeFrame: 2 and 8 weeks post-op.
Secondary outcomes:
measure: Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: 2 and 8 weeks post-op.
measure: Self-reported foot and ankle score (SEFAS)
timeFrame: 2 and 8 weeks post-op.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05491798: A Big Data-based Cohort Study for Cataract Patients
Official title: A Big Data-based Cohort Study for Cataract Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cataract
Retina Disorder
Keywords: Cataract
Postoperative prediction
Image enhancement
Retina disorder
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 1000
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: All candidates for cataract surgery (phacoemulsification and intraocular lens implantation) within a week.

Brief summary: Cataract is an important cause of blindness and visual impairment worldwide. At present, the only effective treatment method is surgery. The visual function of most patients can be significantly improved after surgery, but there are still 5-20% of patients whose visual function cannot be improved after surgery. Previous studies have found that the surgical complications and postoperative visual function of cataract patients are closely related to the condition of the fundus, but the current fundus camera cannot perform clear fundus imaging of cataract patients, and the existing potential visual inspections, such as retinal visual inspection, are also inaccurate. Predict postoperative visual acuity. Therefore, there is an urgent need for a reliable postoperative effect prediction system for cataract patients to provide reference for both ophthalmologists and patients.

This study intends to collect patient medical record information and traditional/ultra-wide fundus photos and other multi-modal data. Firstly, this study will use artificial intelligence technology to enhance fundus photos of cataract patients to obtain clearer fundus photos. Then this study will use both medical record information and traditional/ultra-wide fundus photographs to predict postoperative vision and visual function of cataract patients.


Eligibility criteria: Inclusion Criteria:

* Candidates for cataract surgery (phacoemulsification and intraocular lens implantation) within a week.

Exclusion Criteria:

* Unwilling or unable to receive fundus photography

Primary outcomes:
measure: Change of best corrected visual acuity
timeFrame: Baseline and 1 week after surgery
measure: Accuracy for detection of retinal disorders
timeFrame: 1 week after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhognshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Haotian Lin, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00602498: Bioequivalency Study of Clarithromycin Tablets Under Fed Conditions
Official title: A Single Dose, Two-Treatment, Two-Period, Two-Sequence Crossover Bioequivalency Study of 500 mg Clarithromycin Tablets Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-01-28
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was the bioequivalence of a potential generic 500 mg clarithromycin tablet formulation compared with Abbott Laboratories 500 mg clarithromycin tablet, Biaxin® following a single 500 mg dose, administered with food.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to clarithromycin or any other macrolide antibiotic.

Primary outcomes:
measure: Bioequivalence
timeFrame: Baseline, Two period, Seven day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: MDS Pharma Services
state: Arizona
Study officials:
affiliation: MDS Pharma Services
name: Irving E Weston, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03784898: Collection of Blood Samples From Patients With Relapsing MS Who Developed ITP After Receiving Lemtrada
Official title: Collection of Blood Samples From Patients With Relapsing Forms of Multiple Sclerosis (RMS) Who Have Developed Immune Thrombocytopenic Purpura (ITP) After LEMTRADA® Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2018-12-24
Enrollment: 13
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: Primary Objective:

To collect blood samples in a new cohort of Relapsing Forms of Multiple Sclerosis (RMS) participants who had developed immune thrombocytopenic purpura (ITP) after LEMTRADA treatment, for future Deoxyribonucleic acid (DNA) analysis as part of a global biomarker project assessing pre-identified candidate single nucleotide polymorphisms (SNPs) associated to the development of ITP after LEMTRADA treatment in RMS participants.

Detailed description: One to 70 days, as screening and inclusion visit(s) were performed the same day or on separate days with a maximum timeframe of 30 days apart. One visit was required for blood draw. However, if a second visit occured, it took place within 40 days of the first visit.

Eligibility criteria: Inclusion criteria :

* Male and female adult participants who had been treated with LEMTRADA, with development of ITP subsequent to treatment. Participants does not need to be currently on LEMTRADA treatment.
* Participants who had signed the study ICF.

Exclusion criteria:

- Not applicable

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Primary outcomes:
measure: Number of Participants Who Provided Whole Blood Samples for DNA Extraction and Analysis
timeFrame: Baseline (Day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Investigational Site Number 8400001
state: California
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT00735098: The Effects of Home-Based Rehabilitation Treatments Among Persons With Symptomatic Knee Osteoarthritis
Official title: The Effects of Home-Based Rehabilitation Treatments Among Persons With Symptomatic Knee Osteoarthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Knee Osteoarthritis
arthritis
Lead sponsor: University of Zululand
Sponsor class: OTHER
First posted: 2008-08-14
Enrollment: 44
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Knee Osteoarthritis (OA) is one of the most frequent causes of physical disability and pain among adults. Recent evidence suggests that shorter exercise programs that incorporate kinesthesia, balance and agility (KBA) techniques may result in more rapid symptom relief and functional improvements in comparison to traditional therapeutic exercise. KBA techniques are designed to improve dynamic joint stability by using a series of activities which challenge balance and coordination. To determine the independent effects of KBA training on functional abilities, it is necessary to test it as a training program unto itself. The proposed clinical trial is designed to do this by using three training groups: KBA only; lower extremity strength training only; and a combination of the two. The total exercise time and intensity of each condition will be approximately equal. A non-exercise group will control for any effects related to the testing procedures and the passage of time. Community volunteer men and women age 50 and over with physician diagnosed symptomatic knee OA will participate.


Eligibility criteria: Inclusion Criteria:

* Aged 50 years or over of either gender
* Self-reported knee pain
* Physician diagnosed tibiofemoral OA, unilateral or bilateral, per ACR guidelines
* Demonstrated minimal knee OA related dysfunction per WOMAC score
* Not engaged in a regular leg exercise program for minimum of 6 months

Exclusion Criteria:

* High risk health status per (e.g.) ACSM guidelines
* Inability to obtain physician release for exercise
* Unresolved balance disorder
* Unresolved neurological disorder
* History of knee surgery or major knee trauma injury
* Hip or ankle instability, excessive weakness, surgery or major trauma injury
* Hip or knee replacement
* Intra-articular joint injection within 4 weeks of the study

Primary outcomes:
measure: (WOMAC) self assessment of physical function
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
facility: University of Zululand
state: Florida
Study officials:
affiliation: University of Zululand
name: Matthew W Rogers, MS
role: PRINCIPAL_INVESTIGATOR
References: