louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04520841: Clinical Trial Comparing Negative Pressure Wound Therapy and Standard Dry Dressings
Official title: Monocentric Randomized Clinical Trial Comparing Negative Pressure Wound Therapy (PREVENA™) and Standard Dry Dressings on Oozing of Closed Incision After Revision Total Hip and Knee Arthroplasty Surgery or Lower Extremity Amputation Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arthroplasty Complications
Amputation
Prosthesis-Related Infections
Keywords: Prevena
Negative Pressure Wound Therapy
Revision Arthroplasty
Lower Extremity Amputation Surgery
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2020-08-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Negative pressure dressings are currently widely used in wound management. Their use is gradually being extended to surgical scars. However, studies demonstrating a clear benefit are rare, particularly in terms of postoperative discharge, the need for surgical revision due to prolonged oozing and cost.

The aim of this study is to evaluate the benefit of such a device in post-operative revision prosthesis surgery (hip and knee), as well as lower limb amputations.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Age ≥ 18 years old
* Planned Surgery :

  1. revision of a hip or knee prosthesis, in 1 or 2 stages, at explantation and/or reimplantation, where
  2. elective amputation of a lower limb (transmetatarsal, trans-tibial (Burgess) or trans-femoral (Gritti-Stokes) level (nb: patients for whom amputation of both lower limbs is planned will be excluded)

Exclusion Criteria:

* Known allergy to dry dressings
* Patient already included in another clinical trial
* Inability to discern and/or inability to follow study procedures
* Known allergy to silver or another component of the system Prevena™
* Amputation for tumor pathology

Primary outcomes:
measure: Discharge after 7 days
timeFrame: Day 7- Day 8
Secondary outcomes:
measure: Complications
timeFrame: Day 0 - Day 14
measure: Revision surgery
timeFrame: Day 0 - Day 14
measure: Hospitalisation
timeFrame: Day 0 - Day 14
measure: Patient satisfaction
timeFrame: Day 7
measure: Costs
timeFrame: Day 0 - Day 7
measure: AE & ADE
timeFrame: Day 0 - Day 14
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Lausanne University Hospital
state: Vaud
Study officials:
affiliation: Lausanne University Hospital (Switzerland)
name: Sylvain Steinmetz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03389841: Home Care for the Patient With Heart Failure: Can Caregiver Education Prevent Hospital Admissions?
Official title: Home Care for the Patient With Heart Failure: Can Caregiver Education Prevent Hospital Admissions? A Clinical Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: home care services
comorbidity
heart failure
caregivers
health education
patient admission
Lead sponsor: Italian College of General Practitioners
Sponsor class: OTHER
Collaborators: name: University of Modena and Reggio Emilia
name: Local Health Authority of Modena
First posted: 2018-01-04
Enrollment: 434
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study is aimed to evaluate if the education of the caregiver is able to reduce hospital admissions of patients with heart failure assisted at home.

Detailed description: The primary objective of the study is to assess whether an educational intervention aimed at increasing the caregiver's skills is able to reduce hospital admissions for any cause in patients with heart failure assisted at home.

The General Practitioners who agree to participate are randomized in two groups: a) intervention group, whose patients are assisted in accordance with the procedures established by the project; b) control group, whose patients continue to be assisted in the usual modality.

The intervention consists of an educational session for each caregiver aimed at improving his ability to recognize early symptoms and signs of heart failure.

Eligibility criteria: Inclusion Criteria:

* adults of any age and gender in NYHA (New York Heart Association) classes II, III, IV, assisted exclusively at home;
* willingness and ability to sign a written informed consent;
* presence of a person who cared for the patient in a prevalent and regular way;
* willingness of the caregiver to attend a training meeting.

Primary outcomes:
measure: Hospital admissions for any cause
timeFrame: Twelve months
Secondary outcomes:
measure: Hospital admissions for cardiovascular causes
timeFrame: Twelve months
measure: Mortality for general or cardiovascular causes
timeFrame: Twelve months
Other outcomes:
Locations:
Study officials:
References:
citation: Padula MS, D'Ambrosio GG, Tocci M, D'Amico R, Banchelli F, Angeli L, Scarpa M, Capelli O, Cricelli C, Boriani G. Home care for heart failure: can caregiver education prevent hospital admissions? A randomized trial in primary care. J Cardiovasc Med (Hagerstown). 2019 Jan;20(1):30-38. doi: 10.2459/JCM.0000000000000722.
Clinical trial NCT02429141: Periarterial Injection Versus Multiple Periveural Injection
Official title: The Ultrasound Guided Periarterial Injection Technique To Axilary Brachial Plexus Block Versus Perineural Multiple InjectionTechnique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contusion Wrist or Hand
Crush Injury Wrist or Hand
Lead sponsor: North American Institute for Continuing Medical Education (NAICE)
Sponsor class: OTHER
First posted: 2015-04-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the transarterial technique for axillary brachial plexus block, the axillary artery is intentionally punctured to indicate placement of the needle within the neurovascular sheath; local anesthetic is then injected deep and superficial to the axillary artery.

Detailed description: To lessen the risk for hematoma and intravascular injection, several modifications, such as the multi-injection perineural technique, have become popular. These techniques require a high degree of technical skill and multiple needle passes, and also carry potential for injury. In this study, the investigators will compare an ultrasound-guided equivalent of the transarterial technique (periarterial injections) to a commonly used multi-injection perineural technique.

Eligibility criteria: 1. Inclusion criteria:

   - Patients (ASA physical status I-III) scheduled to undergo hand or wrist surgery under axillary brachial plexus block
2. Exclusion criteria:

   * Patients with pre-existing neuropathy
   * Patients with allergy to local anesthetics
   * Patients with prior surgery in the ipsilateral axilla
   * Pregnant patients
   * Patients with difficulties in communication

Primary outcomes:
measure: Block procedure time for the axillary brachial plexus block
timeFrame: time of the block achievement will be recorded up to 15 minutes
Secondary outcomes:
measure: Onset of the block
timeFrame: outcome measure will be measured up to 30 minutes a
measure: Time to request pain medication
timeFrame: participants will be followed for 3 days
measure: Block success rate
timeFrame: participants success or block failure within 24 hours
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Department of Anesthesiology Ziekenhuis Oost-Limburg
Study officials:
affiliation: Director
name: Admir Hadzic, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06899841: Dexmedetomidine in Sonographic Guided Erector Spinae Plane Block
Official title: Effect of Different Doses of Dexmedetomidine Added to Local Anesthetic in Sonographic Guided Erector Spinae Plane Block for Pain Management After Renal Surgeries : Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Pain Management
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to investigate the postoperative analgesic effect of dexmedetomidine addition with different doses as an adjuvant to bupivacaine to Erector spinae plane block after renal surgeries.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 70 years.
* Both sexes, males and females.
* Patients with the American Society of Anesthesiologists (ASA) physical status I/II.
* Body mass index (BMI) of 18-35 kg/m2
* Patients scheduled for elective Renal or Percutaneous Nephrolithotomy.

Exclusion Criteria:

* Patients under 18 years.
* Patient refusal of nerve block.
* Infection at the site of injection.
* Coagulopathy.
* Allergy to used medications.
* Psychiatric disorder or chronic pain syndromes.
* Chronic opioid use or substance abuse.
* Quadriplegic patients.

Primary outcomes:
measure: postoperative analgesic duration
timeFrame: 24 hours
Secondary outcomes:
measure: Pain score
timeFrame: 24 hours
measure: side effects
timeFrame: 24 hours
measure: dynamic pain score
timeFrame: 24 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospitals
state: Assiut Governorate
Study officials:
References:
Clinical trial NCT02711241: Optimal Analgesia in Acute Gastroenteritis
Official title: Optimal Analgesia in Acute Gastroenteritis in Emergency Department Setting: Dipyrone Versus Papaverine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Gastroenteritis
Keywords: Gastroenteritis
Analgesia
Emergency department
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2016-03-17
Enrollment: 15
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 purpose of this study is to find out an optimal way of analgesia in case of acute infectious gastroenteritis the investigators are going to compare two medicines that are used on everyday basis (without being ever before subject to scientifical study): Dipyrone and papaverine The study is done in the Emergency Department setting. Thus, only first 6 hours of treatment is included in study


Eligibility criteria: Inclusion Criteria:

* acute gastroenteritis
* VAS scale of pain perception at least 4

Exclusion Criteria:

* pregnancy
* allergy to any one of study preparations
* blood pressure less than 85 on admission
* surgical condition (acute abdomen) suspected or diagnosed

Primary outcomes:
measure: Change in pain assessment (VAS) as opposed the pain assessment on admission
timeFrame: 30 min, 1 hour, 2 hours, on discharge (up to 24 hours)
Secondary outcomes:
measure: Need for second analgesic medicine
timeFrame: 24 hours
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadssah Medical Organisation
Study officials:
affiliation: Hadassah Medical Organization
name: Ruth Stanikowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00258141: Study With Rupatadine in Mosquito-Bite Allergic Adult Subjects
Official title: A Placebo-Controlled, Double-Blind, Cross-Over Study With Rupatadine 10 Mg in 30 Mosquito-Bite Allergic Adult Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Allergy
Lead sponsor: J. Uriach and Company
Sponsor class: INDUSTRY
First posted: 2005-11-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The study will find out how effective rupatadine is in the treatment of mosquito bite symptoms in adult patients allergic to mosquito bites.

Detailed description: Mosquito-bite symptoms include wheals and pruritic bite papules. Oral antihistamines have shown to decrease whealing ang accompanying pruritus in placebo-controlled trials.

Subjects will be treated for 4 days, and exposed to experimental mosquito bite at day 3.

Eligibility criteria: Inclusion Criteria:

* Recent history of suffering from mosquito-bite reactions.
* At least 5 mm diameter mosquito-bite wheal from Aedes aegypti laboratory mosquitoes

Exclusion Criteria:

* Pregnancy or lactating females
* Oral antihistamines, corticosteroids or non-steroid anti-inflammatory drugs (NSAID) use within two weeks before the study.
* Severe or moderate systemic illness
* Allergy to rupatadine or other antihistamines
* Anaphylaxis from mosquito bites

Primary outcomes:
measure: Bite lesion size (squared mm)
Secondary outcomes:
measure: Pruritus on a Visual Analog Scale
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: Ulappatorin Lääkäriasema
city: Tampere
country: Finland
facility: Koskiklinikka, Tampere Lääkärikeskus
Study officials:
affiliation: Medical School, University of Tampere and Tampere University Hospital
name: Timo Reunala, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02249741: Prospective Study of Profile of Hepatic Osteodystrophy in Patients With Non-Choleastatic Liver Cirrhosis and Impact of Bisphosphonate Supplementation
Official title: PROSPECTIVE STUDY OF PROFILE OF HEPATIC OSTEODYSTROPHY IN PATIENTS WITH NON-CHOLEASTATIC LIVER CIRRHOSIS AND IMPACT OF BISPHOSPHONATE SUPPLEMENTATION
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cirrhosis
Lead sponsor: Sir Ganga Ram Hospital
Sponsor class: OTHER
First posted: 2014-09-26
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Background and Objectives: Patients with liver cirrhosis are more prone to develop reduced bone mineral density i.e. hepatic osteodystrophy (HOD). It includes both osteopenia and osteoporosis and may lead to increased fracture risks. There is scanty data on prevalence of HOD in Indian population and its treatment outcome. The investigators aimed to determine prevalence of HOD, factors associated with it and the impact of bisphosphonates on bone mineral density in patients with liver cirrhosis.

Patients and Methods: Consecutive patients with liver cirrhosis admitted at Sir Ganga Ram Hospital, New Delhi between August 2012 and July 2013 were enrolled. Patients with chronic kidney disease, hyperparathyroidism and those on steroids were excluded. Bone mineral density (BMD) was measured by dual-energy X-ray absorptiometry (DEXA) at the lumbar spine and femoral neck. Osteopenia and osteoporosis were defined according to WHO criteria. All patients also underwent 25-hydroxy-vitamin-D, sex hormone (testosterone in male and LH and Estradiol in female) and parathyroid hormone (PTH) along with routine investigations. Transient elastography was also done in all patients. Ibandronic acid 150 mg per day orally for six months was given in patients with osteoporosis and DEXA scan repeated.


Eligibility criteria: Inclusion Criteria:

1. Liver Cirrhosis
2. Age 18-70 years
3. Informed and written consent

Exclusion Criteria:

1. Chronic renal failure
2. Prolonged steroid use more than 3 months
3. Patients on immunosuppressive therapy
4. Primary hyperparathyroidism
5. Post menopausal women
6. Pregnancy
7. Cushing's syndrome
8. Malignancy
9. HIV Co-infection

Primary outcomes:
measure: Improvement in Bone Mineral Density on DEXA scan
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of new fractures
timeFrame: 6 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital
Study officials:
References:
Clinical trial NCT02236741: The Use of Pramipexole and Other Dopamine Agonists and the Risks of Heart Failure and Pneumonia
Official title: The Use of Pramipexole and Other Dopamine Agonists and the Risks of Heart Failure and Pneumonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-11
Enrollment: 26814
Sex: ALL
Minimum age (years): 40
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Users of anti-parkinsonian drugs registered with an up-to-standard practice from the United Kingdom's General Practice Research Database (GPRD)

Brief summary: Study to assess the risk of incident heart failure associated with the use of pramipexole compared with other dopamine agonists and additionally, to assess the risk of incident heart failure associated with the use of dopamine agonists in comparison with no use of dopamine agonist therapy


Eligibility criteria: Inclusion Criteria:

* All patients between 40 and 89 years of age who received at least one prescription for anti-parkinsonian drugs during the period 1997-2009

Exclusion Criteria:

* Patients with a diagnosis of heart failure or with prescriptions for two or more among the digitalis, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blocker (ARB), and diuretic drug classes prior to cohort entry

Primary outcomes:
measure: Assessment of first-time clinical diagnosis of heart failure
timeFrame: 150 months
Secondary outcomes:
measure: Overall rate of heart failure
timeFrame: 150 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00662441: Evaluating of the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction
Official title: Open-Label, Multi-Centre, Study of Levitra 10 mg Once a Day in Males With Erectile Dysfunction Was Carried Out in Four Centres Namely Lagos, Port Harcourt, Enuge and Maiduguri at Their University Teaching Hospitals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
Vardenafil
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2008-04-21
Enrollment: 102
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. An ideal treatment option should be effective and reliable, have minimal side effects, be simple to use and affordable. The purpose was the evaluation of efficacy and safety of 10 mg oral Vardenafil in Nigerian subjects with Erectile Dysfunction (ED).


Eligibility criteria: Inclusion Criteria:

* Men \>/= 18 years of age
* Erectile Dysfunction

Exclusion Criteria:

* History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
* Nitrate therapy
* Other exclusion criteria apply according to the Summary of Product Characteristics

Primary outcomes:
measure: International Index of Erectile Function- Erectile Function domain
timeFrame: 8 weeks
Secondary outcomes:
measure: Global Assessment Questionnaire (GAQ)
timeFrame: 8 weeks
measure: Safety and tolerability
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01885741: Study to Demonstrate the Preliminary Safety and Effectiveness of IPBS in Performing MRI-Guided Targeting and Intervention of Breast Tissue in Female Patients Indicated for MRI-Guided Breast Biopsy
Official title: A Prospective, Open-Label, Single-Arm, Single-Site, Study to Demonstrate the Preliminary Safety and Effectiveness of IPBS in Performing MRI-Guided Targeting and Intervention of Breast Tissue in Female Patients Indicated for MRI-Guided Breast Biopsy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Screening
MRI Guided Breast Biopsy
Breast Cancer Diagnosis
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2013-06-25
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A preliminary demonstration of the Safety of IPBS in positioning a vacuum assisted biopsy (VAB) tool to enable an MRI-guided automated breast biopsy. This will consist of 10-15 biopsy procedures facilitated by the MRI-guided system. Patients will be followed after the procedure to assess clinical outcomes.


Eligibility criteria: Inclusion Criteria:

* Female patients over the age of 18 with suspected or confirmed breast cancer requiring a manual MRI-guided breast biopsy for diagnosis and staging.
* Individuals Capable of giving a free and informed consent.

Exclusion Criteria:

* Any patient for whom the manual MRI-guided breast biopsy procedure would not be possible (size of patient, etc.).
* Patients who refuse the procedure for any reason will be excluded from the study at the investigators discretion.
* Patients who are not suitable for the procedure will be excluded at the investigators discretion.
* Patients unwilling to complete associated study questionnaires or follow up visits.
* Women who are pregnant or who plan to become pregnant within the study duration.

Primary outcomes:
measure: Frequency of target reached by the interventional tools as determined by a qualified physician reviewing the MR images.
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: Quebec City
country: Canada
facility: Hopital du Saint-Sacrement
state: Quebec
Study officials:
References: