louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05007158: Validation of Procalcitonin as a Biomarker Diagnosing CDI
Official title: A Prospective Case-control Validation of Procalcitonin as a Biomarker Diagnosing Pacemaker and Implantable Cardioverter Defibrillator Pocket Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Implantable Electronic Device Infections
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients presenting with cardiac device infection CDI

Brief summary: Cardiac device infections (CDI), especially pocket infections, are difficult to be diagnosed. Device pocket infections are not associated with elevated white blood cell count. CRP is only assoziated with a low sensitivity. The diagnosis of a local pocket infection is challenging and relies primarily on the clinical presentation. The prospective DIRT study identified procalcitonin (PCT) among 14 biomarkers as the most promising biomarker to aid the diagnosis of pocket infection.

The study aims to validate the proposed PCT cut-off value of 0.05 ng/ml for the diagnosis of pocket infection


Eligibility criteria: Inclusion Criteria:

• device associated infections

Exclusion Criteria:

* malignancy
* cytostatic or immunomodulating therapy

Primary outcomes:
measure: diagnostic value of PCT
timeFrame: pre-intervention/procedure/surgery. i.e. at the time of CIED explantation. Measurement of PCT as an biomarker revealing the acute infection (like a sepsis marker)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00970658: Efficacy and Safety of Salonsip Compared to Sabiá Plaster
Official title: Clinical Multicenter Study, Randomized, Open, to Evaluate the Efficacy and Safety of Salonsip Compared to Sabiá Plaster Relief of the Signs and Symptoms in Patients With Contusions, Sprains, Injuries and Muscular Injuries With Less Than 24 Hours Early or Holders of Myalgia, Pain and Tendonitis in Regions Miofasciais Articulated.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Contusions
Sprains
Myalgia
Pain
Tendonitis
Keywords: Plaster
injuries
regions miofasciais articulated
Reducing signs, symptoms
Lead sponsor: Hisamitsu Farmaceutica do Brasil Ltda
Sponsor class: INDUSTRY
First posted: 2009-09-02
Enrollment: 70
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy in reducing signs and symptoms in patients with contusions, sprains, muscular injuries and injuries with less than 24 hours early or holders of myalgia, pain and tendonitis in regions miofasciais articulated with Salonsip compared to Sabiá plaster.

It is clinical, open, multicenter, randomized, prospective and comparative, with patients entering at random.

Patients will be included in sufficient quantity to achieve the minimum number of 70 evaluable patients.


Eligibility criteria: Inclusion Criteria:

* Patients of both sexes, of any race, aged 12 years;
* Ability to read, understand and sign the Consent Form, in the case of children under age monitoring and consent of the person responsible;
* Clinical diagnosis of bruises, sprains, trauma, muscle damage occurring in times less than 24 hours or myalgia, pain miofasciais or tendonitis.
* Patients able to understand and maintain the clinical protocol

Exclusion Criteria:

* Known hypersensitivity to components of the formulas of both the product and the comparative test.
* Known hypersensitivity to paracetamol.
* Location of the lesion with skin wound or irritated.
* Hepatic or renal diseases known.
* Pregnant or breastfeeding.
* Patients who require surgery or immobilization rigid;
* Patients with fractures or rupture of the ligaments.
* Patients in use of anticoagulants.
* Patients with severe concomitant systemic diseases such as cancer, diabetes, congenital or acquired heart disease, hematological diseases, convulsive disorders, autoimmune diseases, renal failure, infections, hormonal disorders and pulmonary disorders.
* History of alcoholism or use of illicit drugs;
* Use of non-steroidal anti-inflammatory drugs, corticosteroids or venoterápicos, topics or any other form of administration.
* Conditions which in the opinion of the investigator makes the patient unsuitable to participate in the study.

Primary outcomes:
measure: Likert Scales and Visual Analogue Scales
timeFrame: two days
Secondary outcomes:
measure: Safety evaluation by adverse events relate.
timeFrame: two days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02095158: A Long-Term Safety and Efficacy Study AGN-19920 in Patients With Persistent Erythema Associated With Rosacea
Official title: A Long-term Safety and Efficacy Study of Oxymetazoline HCl Cream 1.0% in Patients With Persistent Erythema Associated With Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erythema
Rosacea
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-03-24
Enrollment: 440
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: This study will evaluate the long-term safety and efficacy of oxymetazoline hydrogen chloride (HCL) Cream 1.0% (AGN-199201) in patients with persistent erythema associated with rosacea.


Eligibility criteria: Inclusion Criteria:

-Moderate to severe persistent facial erythema associated with rosacea.

Exclusion Criteria:

* Current treatment with monoamine oxidase (MAO) inhibitors
* Raynaud's syndrome, narrow angle glaucoma, orthostatic hypotension, scleroderma or Sjogren's syndrome.

Primary outcomes:
measure: Percentage of Participants With Treatment-Related Adverse Events
timeFrame: 56 Weeks
Secondary outcomes:
measure: Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) Using 5-Point Scales
timeFrame: Baseline, Day 1 Hours 3 and 6, Week 4 Predose and Hours 3 and 6, Week 12 Predose, Week 26 Predose and Hours 3 and 6, Week 39 Predose, Week 52 Predose and Hours 3 and 6, Week 54 Predose
Other outcomes:
Locations:
city: Portland
country: United States
state: Oregon
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02534558: Pathomechanism of MicroRNA-29 in Shoulder Stiffness
Official title: Pathomechanism of MicroRNA-29 in Shoulder Stiffness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stiffness of Shoulder, Not Elsewhere Classified
Keywords: MicroRNA-29
shoulder stiffness
mir-29a
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2015-08-27
Enrollment: 50
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: DIAGNOSTIC

Brief summary: The team integrates experimental analyses of clinical and basic medicine and transgenic mice models. miR-29a acts a potent protective factor against excessive fibrosis in myofibroblasts of subacromial bursa tissue. Gain of miR-29a stabilizes tendon and synovial tissue homeostasis that alleviates tissue stiffness and maintains function.

Detailed description: Aims of first: The team will evaluate the associations among the mR-29a, miR-29b, miR-29c expression in subacromial bursa and subacromial fluid, incidence of shoulder stiffness, Constant scores, and VAS.

Aims of second: The team will isolate primary myofibroblast from subacromial bursa tissue as in vitro models and investigate the molecular events in the IL-1β modulation of miR-29a expression and the molecular mechanism underlying miR-29a inhibition of fibrotic matrix accumulation and apoptotic reactions in myofibroblast cultures.

Eligibility criteria: Inclusion Criteria:

* aged 18 to 80 years
* receiving surgery for open acromioplasty

Exclusion Criteria:

* shoulder disorders caused by traumatic fracture
* previous surgery
* osteoarthritis
* malignant disorders
* hepatic disorders
* renal disorders

Primary outcomes:
measure: The microRNA expression, mRNA expression as a measure
timeFrame: 48hr
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung city
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Yang-Jih Ko, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01950858: Hyper Baric Oxygen Therapy (HBOT) for Spontaneous Osteonecrosis of the Knee
Official title: Safety and Efficacy of Hyper Baric Oxygen Therapy (HBOT) in Patients Presenting With Spontaneous Osteonecrosis of the Knee
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Spontaneous Osteonecrosis of the Knee
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-09-26
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: safety and efficacy of Hyper Baric Oxygen (HBO) in patients presenting with spontaneous osteonecrosis of the knee


Eligibility criteria: Inclusion Criteria:

* Age40-85 years
* Diagnosis of Spontaneous osteonecrosis of the knee (SONK)in last month, Stage 1 or 2 by MRI.

Exclusion Criteria:

* Hyperbaric treatment (HBOT) in the last 2 years.
* Any contraindication for HBOT
* Pregnancy.
* Inability to sign inform consent
* Any contraindication for MRI

Primary outcomes:
measure: Efficacy
timeFrame: 6 weeks
measure: Safety
timeFrame: end of HBOT
Secondary outcomes:
measure: Reduction In AVN size by MRI
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf-Harofeh Medical Center
Study officials:
affiliation: Assaf-Harofeh Medical Center
name: Shai Efrati, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02156596: IV NSAI Versus Nebulized Morphine Analgesia for First-line Renal Colic
Official title: Intravenous Treatment With Non Steroidal Anti Inflammatory Drugs (NSAID) Versus Nebulized Morphine (NM) Analgesia for First-line Renal Colic: Randomized Controlled Double-blind Single-center Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Colic
Keywords: renal colic
nebulised morphine
Intravenous NSAID
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2014-06-05
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the investigators study was to evaluate the feasibility, efficacy and safety of nebulized morphine compared with non-steroidal anti-inflammatory (NSAI)intravenously in the management of renal colic.

Determine the need for systematic outpatient prescription of NSAI.

Detailed description: Renal colic are a frequent cause of consultation in the emergency departement (ED).

They count for approximatively 20% of patients presenting to the ED with severe acute onset abdominal pain.

For acute treatment of renal colics (RC), guidelines recommend the use of intravenous (IV) non-steroidal anti-inflammatory (NSAI) drugs in association with antalgics like Paracetamol or Morphine.

But the NSAID present many inconvenient and cannot be used in some type of patients; that's why the investigators investigated the use of other drugs, such as nebulised morphine, in the ED treatment of renal colics.

the NM has the adequacy of being quickest, more practical to use and more tolerated than the IV NSAID.

In this study, the investigators aim to assess the feasibility, efficacity and safety of nebulised morphine compared to intravenous NSAID in the treatment of RC.

Eligibility criteria: Inclusion Criteria:

* Over 16 years old
* Consenting to participate in the study
* Diagnosis of renal colic matching flank pain / lumbar fossa sided with dipstick and / or imaging confirmed the diagnosis
* VAS\> 50% at consultation

Exclusion Criteria:

* Inability to assess pain VAS;
* Pregnant or lactating woman;
* Recognized renal disease (glomerular filtration rate \<60ml/kg/1.73m2);
* Known hepatic insufficiency;
* Known or suspected allergy to NSAIDs, morphine
* Peptic ulcer known;

Primary outcomes:
measure: efficacity: VAS pain reduction
timeFrame: 5, 15, 30, 45 and 60 minutes
Secondary outcomes:
measure: feasibility of the study: number of patients accepting the adhesion to protocol
timeFrame: at base line and at 60 minutes
measure: safety: side effects of treatment
timeFrame: 5, 15, 30, 45 and 60 minutes
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Hospital of Fattouma Bourguiba
Study officials:
affiliation: University of Monastir
name: Nouira Semir, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01397396: Effects of Inspiratory Muscle Training in COPD
Official title: Effects of Inspiratory Muscle Training in Patients With Chronic Obstructive Pulmonary Disease - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COPD
Inspiratory Muscle Weakness
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2011-07-19
Enrollment: 208
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The additional effect of inspiratory muscle training as an adjunct to a general exercise training program in patients with COPD with inspiratory muscle weakness will be studied. The main hypothesis is that inspiratory muscle training combined with an exercise training program improves functional exercise capacity more than an exercise training program without the addition of an inspiratory muscle training program.


Eligibility criteria: Inclusion Criteria:

* Patients with COPD
* Eligible to participate in a exercise training intervention of 8 weeks
* Pi,max \<60cmH2O or \<50% of the predicted normal value

Exclusion Criteria:

* Major comorbidities preventing successful participation in an 8 week exercise training intervention

Primary outcomes:
measure: 6-Minute Walking Distance
timeFrame: Baseline and 8 weeks follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Leuven
Study officials:
affiliation: KU Leuven
name: Rik Gosselink, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Charususin N, Gosselink R, Decramer M, Demeyer H, McConnell A, Saey D, Maltais F, Derom E, Vermeersch S, Heijdra YF, van Helvoort H, Garms L, Schneeberger T, Kenn K, Gloeckl R, Langer D. Randomised controlled trial of adjunctive inspiratory muscle training for patients with COPD. Thorax. 2018 Oct;73(10):942-950. doi: 10.1136/thoraxjnl-2017-211417. Epub 2018 Jun 18.
citation: Charususin N, Gosselink R, Decramer M, McConnell A, Saey D, Maltais F, Derom E, Vermeersch S, van Helvoort H, Heijdra Y, Klaassen M, Glockl R, Kenn K, Langer D. Inspiratory muscle training protocol for patients with chronic obstructive pulmonary disease (IMTCO study): a multicentre randomised controlled trial. BMJ Open. 2013 Aug 5;3(8):e003101. doi: 10.1136/bmjopen-2013-003101.
Clinical trial NCT04744896: Effects Of Combined Cryolipolysis And High Intensity Interval Training On Insulin Resistance And Body Composition In Polycystic Ovarian Patients
Official title: Effects Of Combined Cryolipolysis And High Intensity Interval Training On Insulin Resistance And Body Composition In Polycystic Ovarian Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
Hyperinsulinism
Keywords: pco
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 90
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 28
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cryolipolysis treadmill cryolipolysis + treadmill
Primary purpose: TREATMENT

Brief summary: this study will be carried to investigate the effect of cryolipolysis and high intensity interval training on insulin resistance and body composition in pco women

Detailed description: This study will be carried out on ninety females with polycystic ovarian syndrome (PCOS)l. Their age ranges from 17-28 years, body mass index 25-30 Kg/m2. They experience hyperandrogenism and hyperinsulinemia.

PCOS females will be randomly assigned into three equal groups: group (A) consists of 30 women who receive cryolipolysis and group (B) consists of 30 women who receive high intensity interval training and group (C) receive both

Eligibility criteria: Inclusion Criteria:

* women diagnosed with polycystic ovarian syndrome
* age ranges from 17-28 years
* body mass index ranges 25-30 Kg/m2

Exclusion Criteria:

* Diabetic patients.
* Women with BMI\>30
* Women having circulatory dysfunction.
* Women with respiratory or cardiac disease
* liver disease.
* Skin disease .
* Previous abdominal or uterine surgery
* any medications affecting hormones
* any physical impairments
* Physical impairment

Primary outcomes:
measure: HOMA IR
timeFrame: 3 months
measure: weight
timeFrame: up to 3 months
measure: fat percentage
timeFrame: up to 3 months
Secondary outcomes:
measure: waist circumference
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
state: Giza
Study officials:
affiliation: Cairo University
name: amal mo youssef, phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT01756196: Incidence of Various Types of Systemic Reactions Related to Spinal Steroid Injection: A Prospective Study
Official title: Prospective Observational Study of Evaluate the Incidence and Types of Systemic Reactions After Spinal Steroid Injections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incidence and Types of Systemic Reactions Occurring After Spinal Steroid Injection in a Large Population
Keywords: Spinal injection; Steroid; Systemic reaction; Complication; Side effect; Diabetes mellitus; Hypertension; Risk factor
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2012-12-25
Enrollment: 997
Sex: ALL
Minimum age (years): 13
Maximum age (years): 94
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients receiving the injection were informed of the aim and protocol of this study and the possible local and systemic reactions associated with spinal steroid injection

Brief summary: Many systemic reactions occur commonly after spinal steroid injections, especially in patients, and may be associated with underlying disease, such as hypertension and diabetes mellitus, as well as steroid dose and repetition of spinal steroid injection.

Detailed description: Evaluate the incidence and types of systemic reactions after spinal steroid injections and to investigate the association of spinal steroid injection with patient demographics, history of previous injections, type and dose of steroid, and method and site of previous and current injections.

Eligibility criteria: Inclusion Criteria:

* Indicaion of steroid injction.

Exclusion Criteria:

* Contraindiation of steroid injction.

Primary outcomes:
measure: episodes of systemic reactions after spinal steroid injection
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoung Nam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Bundang
Study officials:
References:
citation: Goldstein G, Schlesinger DH. Thymopoietin and myasthenia gravis: neostigmine-responsive neuromuscular block produced in mice by a synthetic peptide fragment of thymopoietin. Lancet. 1975 Aug 9;2(7928):256-9. doi: 10.1016/s0140-6736(75)90966-6.
Clinical trial NCT05388396: PIMS-TS in Intensive Care: Retrospective Cohort Trial
Official title: Pediatric Inflammatory Multisystem Syndrome (PIMS-TS) in Pediatric Intensive Care: Retrospective Cohort Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pims-Ts
Keywords: PIMS-TS
children
child
intensive care
critical illness
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital Motol and 2nd Faculty of medicine, Charles University, Prague
name: Department of Anaesthesiology and Intensive CareMedicine, The Donaustadt Clinic, Lango Bardenstraße 122, 1220 Vienna, Austria
First posted: 2022-05-24
Enrollment: 180
Sex: ALL
Maximum age (years): 19
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients with PIMS-TS admitted to PICU

Brief summary: Pediatric Multisystem Inflammatory Syndrome Temporally associated with SARS-CoV-2, (PMIS-TS) represents the new unit, partially imitating the previously described Kawasaki disease. Due to variable and frequently incomplete clinical presentation together with variable disease severity, the real incidence in pediatric population remains unclear. Currently, PIMS-TS is defined by persistent fever, elevation of inflammatory markers, organ dysfunction (cardiac, central nervous system, respiratory, coagulation, renal, gastrointestinal), skin lesions (exanthematous), and absence of other possible etiology.

Detailed description: During the world COVID-19 pandemic (2020-2022), pediatric patients with PIMS-TS represented a significant part of pediatric intensive care unit (PICU) load. The initial clinical presentation of patients with PIMS-TS could vary significantly, and also due to progressively evolving recommendations, the diagnostic a therapy could vary regionally and over the time too. The aim of this retrospective cohort trial was to describe the initial clinical presentation, diagnostics, therapy and clinical outcome of pediatric patients admitted during 2020-2022 to the one of the 3 university hospital PICUs.

Eligibility criteria: Inclusion Criteria:

* pediatric patients with PIMS-TS
* PICU admission

Exclusion Criteria:

* insufficient data
* patients not admitted to PICU

Primary outcomes:
measure: Initial clinical presentation
timeFrame: During the first 24 hours after PICU admission
measure: Initial laboratory results
timeFrame: During the first 24 hours after PICU admission
measure: PIMS-TS treatment
timeFrame: During the first month after PICU admission
Secondary outcomes:
measure: PIMS-TS outcome
timeFrame: after one month from hospital discharge
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Brno University Hospital
state: South Moravian Region
Study officials:
affiliation: Department of paediatric anaesthesia and intensive care medicine
name: Petr Stourac, prof. MD., Ph.D., MBA
role: STUDY_CHAIR
References: