louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04845126: Outcomes of Patients With Heart Failure Hospitalized in an Internal Medicine Unit
Official title: Outcomes of Patients With Heart Failure Hospitalized in an Internal Medicine Unit - a Four Years Follow-up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Outcomes
Internal medecine
Heart failure treatment
Heart failure guidelines
quality of life
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-04-14
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized for heart failure or with known heart failure in our Internal Medecine unit between 2016/01/01 and 2018/01/01.

Brief summary: In 2018, the investigators evaluated the treatment of 236 patients with heart failure (with preserved or reduced ejection fraction) before and after hospitalization in our internal medicine unit (from 2016 to 2017).

The investigators showed that patients, mainly elderly women with comorbidities, often had suboptimal heart failure treatment without an identified cause. The investigators tried, whenever possible, to optimize treatment before hospital discharge.

Our objective is now to analyze the 4-year outcome of these patients, including re-hospitalization for heart failure or death.


Eligibility criteria: Inclusion criteria:

- Patients hospitalized in our Internal Medecine unit for acute heart failure or for another cause but with known chronic heart Failure

Exclusion criteria:

- Hemodilaysis, end stage kidney disease, heart failure cause by anuria, heart transplantation

Primary outcomes:
measure: re-hospitalization for heart failure or death failure assessed by spirometry
timeFrame: 1 day
Secondary outcomes:
measure: time to re-hospitalization
timeFrame: 1 day
measure: time to death
timeFrame: 1 day
measure: cause of hospitalization
timeFrame: 1 day
measure: cause of death
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University hospital of Montpellier
Study officials:
affiliation: UH MONTPELLIER
name: Pierre Fesler, PUPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT03603626: Preemptive Pregabalin in Myringoplasty
Official title: Effect of Preemptive Pregabalin for Post-operative Pain Relief in Myringoplasty
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Post-operative Analgesia
CSOM - Chronic Suppurative Otitis Media
Keywords: Endoscopic ear surgery
Myringoplasty
Pregabalin
Preemptive analgesia
Lead sponsor: Dhulikhel Hospital
Sponsor class: OTHER
Collaborators: name: Kathmandu University School of Medical Sciences
First posted: 2018-07-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to investigate the effect of preemptive pregabalin on post-operative pain reduction after myringoplasty.

Detailed description: Patient were randomly assigned to one of two groups with 30 participants each by lottery method. Pregabalin group received capsule Pregabalin 150mg and Placebo group were given Vitamin B capsule 1 hour prior to surgery.

All patients underwent endoscopic myringoplasty with tragal cartilage and perichondrium graft. Surgical procedure was done under local anesthesia. 5ml of 2% xylocaine with 1:2,00,000 adrenalin was infiltrated in the four quadrants of external ear canal and on tragus. Around 2cm incision was given on canal surface of tragus and around 2cm x 1.5cm cartilage- perichondrium graft was obtained. The skin was closed with 4/0 prolene interrupted suture. Using rigid Hopkins II 0-degree endoscope (Karl Storz) with 4-millimeter diameter and 18 centimeters in length, margin of perforation was refreshed. Gelatin sponge was kept in the middle ear and cartilage perichondrium graft placed. Canal was then packed with gelatin soaked in ciprofloxacin ear drops followed by ribbon pack medicated with soframycin. Small dressing was applied over it.

Post-operative pain severity was assessed with VAS scale at 6, 12, 24, 48 hours. Rescue analgesia is given with Injection Ketorolac (30mg IV) or Tab Flexon (Ibuprofen 400mg + Paracetamol 500mg) whenever the patient required.

Eligibility criteria: Inclusion Criteria:

* Cases of Chronic suppurative otitis media (CSOM) inactive planned for endoscopic myringoplasty under local anesthesia,
* Age \>= 18 years
* either sex.

Exclusion Criteria:

* Revision cases,
* Pregnancy or breastfeeding,
* Known or suspected sensitivity or contraindication to pregabalin,
* Patient using medication for chronic pain,
* History of seizure disorder,
* Mental retardation.

Primary outcomes:
measure: This study is constructed to determine whether the use of preemptive single dose oral pregabalin would decrease post-operative pain in patient undergoing myringoplasty.
timeFrame: At 6, 12, 24, 48 hours in postoperative period
Secondary outcomes:
Other outcomes:
Locations:
city: Dhulikhel
country: Nepal
facility: Dhulikhel Hospital
state: Kavre
Study officials:
References:
Clinical trial NCT05765526: A Novel Electrolyzed Water Spray Treatment for the Discomfort or Itching of Patients With Scalp
Official title: A Novel Electrolyzed Water Spray Reduces Discomfort or Itching Scores of Patients With Scalp Discomfort or Itching: A Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scalp Dermatoses
Keywords: Electrolyzed water device
Hydroxyl radical
Tap water
Spray
Scalp discomfort
Scalp itching
Lead sponsor: Dove Medical Press Ltd
Sponsor class: NETWORK
First posted: 2023-03-13
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: An open label, single arm and before and after treatment
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test whether the reduction of the discomfort or itching with the scalp of patients by use of the novel electrolyzed water spray will produce improvement in the condition of the scalp.

Detailed description: In this study, water inculding tap water,pure water and salt water, and an apparatus for producing electrolyzed water (https://www.deposon.com.cn; https://www.deposon.com）were used to generate an electrolyzed water mist spray or spray. This instantly generated electrolyzed water mist spray or spray has oxidation-reduction potential (ORP) ≥1200mv,and contains non-specific total oxidation capacity which equals to 0.28±0.10ppm,0.06±0.04ppm and 3.92±0.39ppm of desolved ozone. This instantly generated electrolyzed water mist spray or spray does not release detectable ≥0.1mg/m3 of gaseous ozone. This instantly generated electrolyzed water mist spray or spray has pH 8.4±0.4 and releases negative air ion.The apparatus for producing electrolyzed water has a positive electrode which is covered by a conductive diamond material (Patent# CN215308550U). This is an open-label, single-arm and before and after treatment comparison study. In this study, this novel electrolyzed water device and the water spray are used to treat scalp itching. The reduction in the scalp of discomfort or itching evaluation and adverse event assessments will be performed at each visit. Safety analysis will be assessed based on the reports of adverse events during the study.

Eligibility criteria: Inclusion Criteria:

* The patients with scalp discomfort or itching

Exclusion Criteria:

* severe scalp discomfort or itching; 80 years or elder

Primary outcomes:
measure: A discomfort or itching scale made by modifing a pain scale (NPRS)
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Huinuode Biotechnology Co., Ltd.
Study officials:
References:
Clinical trial NCT03772457: Predictive Value of Infarction Volume on Hemorrhagic Transformation in Ischemic Stroke/TIA With Non-valve Atrial Fibrillation(NVAF) Patients Using Rivaroxaban
Official title: To Explore the Predictive Value of Infarction Volume on Hemorrhagic Transformation in Newly Diagnosed Ischemic Stroke/TIA With Non-valve Atrial Fibrillation(NVAF) Patients Using Rivaroxaban
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebrovascular Stroke
Intracranial Hemorrhages
Anticoagulant
Matrix Metalloproteinases
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Bayer
name: Taizhou Hospital
name: Zhuji People's hospital
name: Shaoxing People's Hospital
name: Jinhua Central Hospital
name: HaiyanPeople's hospital
name: Wenzhou Central Hospital
name: The Central Hospital of Lishui City
name: Dongyang People's Hospital
name: Rui'an People's hospital
First posted: 2018-12-11
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Newly diagnosed ischemic stroke/TIA patients with NVAF who sign the informed consent and receiveRivaroxaban treatment in the in-patient ward.

Brief summary: This study was aimed at patients with newly diagnosed stroke / TIA associated with nonvalvular atrial fibrillation. We will observe the effect of early using rivaroxaban anticoagulation on hemorrhagic transformation, and explore the predictive value of multi-mode MRI infarct volume / MMP-9 on hemorrhagic transformation after anticoagulation therapy.


Eligibility criteria: Inclusion Criteria:

1. Male or female, age≥18;
2. Were newly diagnosed asischemic stroke/TIA concomitant NVAF;
3. Prescribedand accept Rivaroxaban;
4. Sign thewritten informed consent.

Exclusion Criteria:

1. Renal impairment (CrCl\<15 ml/min) or severe hepatic impairment.
2. Significant hemorrhagic transformation (parenchymal hematoma type I or type II by the ECASS definition).
3. Stroke or TIA caused by large artery atherosclerosis
4. Planned major surgery or invasive intervention
5. Active internal bleeding
6. Malignancy or other serious medical conditions with a life expectancy \<6 months
7. Allergery to Rivaroxaban
8. Pregnancy or breast-feeding

Primary outcomes:
measure: Susceptibility weighted imaging(SWI) detection of newly developed hemorrhagic transformation after 14 days of rivaroxaban treatment
timeFrame: 14 days after enrolling
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Min Lou, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02608957: Evaluation of the Latella™ Knee Implant System for Medial Osteoarthritis Pain Reduction
Official title: Evaluation of the Latella™ Knee Implant System for Medial Osteoarthritis Pain Reduction (Latella-US Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Cotera, Inc.
Sponsor class: INDUSTRY
First posted: 2015-11-20
Enrollment: 1
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the Latella-US study is to demonstrate the safety and efficacy of the Latella Knee Implant System for the reduction of medial osteoarthritis pain.


Eligibility criteria: Inclusion Criteria:

* History of pain due to medial osteoarthritis
* Qualifying baseline pain scores
* Kellgren-Lawrence Grades 2-3

Exclusion Criteria:

* Osteoporosis
* Rheumatoid arthritis
* Joint instability
* Metal ion allergy
* Permanent implant in or around the knee joint
* Prior anterior cruciate ligament reconstruction

Primary outcomes:
measure: Primary Efficacy Endpoint: Mean change in KOOS pain score at 6 months
timeFrame: 6 Months
measure: Primary Safety Endpoint: Surgical re-intervention rate at 6 months
timeFrame: 6 Months
Secondary outcomes:
measure: Change in KOOS function score
timeFrame: 6, 12 and 24 months
measure: Change in medial knee pain NRS (while walking)
timeFrame: 6, 12 and 24 months
measure: Change in IKDC score
timeFrame: 6, 12 and 24 months
measure: Device-related complications rate
timeFrame: 24 months
measure: KOOS responder rate based on OARSI-OMERACT criteria
timeFrame: 6, 12 and 24 months
measure: Proportion of subjects reaching MCID in KOOS pain score
timeFrame: 6, 12 and 24 months
measure: Change in KOOS pain score
timeFrame: 12 and 24 months
measure: Surgical re-intervention rate
timeFrame: 12 and 24 months
measure: Procedure-related complications rate
timeFrame: 24 Months
Other outcomes:
Locations:
city: Washington
country: United States
facility: The George Washington University
state: District of Columbia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References:
Clinical trial NCT03187457: PreFem: "What Happens to the Vaginal Microbiota When a BV Infection is Treated With Metronidazole?"
Official title: PreFem: "What Happens to the Vaginal Microbiota When a BV Infection is Treated With Metronidazole?"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacterial Vaginosis
Lead sponsor: Danisco
Sponsor class: INDUSTRY
Collaborators: name: Community Pharmacology Services Ltd
First posted: 2017-06-15
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The study will assess vaginal microbiota levels before and after antibiotic treatment in females infected with Bacterial Vaginosis (BV).

Detailed description: This method validation study will endeavour to obtain evidence for:

* Recruitment methodology effectiveness
* The usefulness of the "Canestest" test as a screening tool
* The time required for the vaginal microbiota (particularly Lactobacillus count) to return to normal after treatment of BV infection with metronidazole.
* The time required for the Nugent Score to return to normal after treatment of BV infection with metronidazole.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Female gender
* Over 18 years of age
* Have a high probability for compliance with and completion of the study

Exclusion Criteria:

* Hypersensitivity to metronidazole --only applies to Group 2.
* Post-menopausal defined as at least 12 consecutive months without menstruation
* Treatment of BV in last 4 weeks
* Clinically significant menstrual irregularities
* Suspected presence of STDs or other vaginal infection
* Pregnancy
* Breast feeding
* Participation in other clinical studies which could influence genitourinary tract microbiota
* Substance abuse
* Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study

Primary outcomes:
measure: Change in vaginal microbiota assessed with sequencing
timeFrame: Baseline, at day 8, and at day 15
Secondary outcomes:
measure: Vaginal microbiota/lactobacilli levels with Nugent scoring
timeFrame: Baseline, at day 8, and at day 15
measure: Diagnosis of BV with "Canestest"
timeFrame: Baseline
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: CPS Research
Study officials:
affiliation: CPS Research
name: Gordon Crawford, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02033057: Muscular Electrostimulation of the Sedated and Mechanically Ventilated Critically Ill Patient. Analysis of the Effect on Acquired Muscular Weakness and Its Clinical Consequences.
Official title: Muscular Electrostimulation of the Sedated and Mechanically Ventilated Critically Ill Patient. Analysis of the Effect on Acquired Muscular Weakness and Its Clinical Consequences.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Polyneuropathy
Keywords: Muscular electrostimulation, mechanically ventilated, critically ill patients, muscular weakness.
Lead sponsor: Hospital Universitario La Fe
Sponsor class: OTHER
First posted: 2014-01-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Even 20-50% of patients under sedation and mechanical ventilation develops myopathy and / or neuropathy which difficulties both the process of extubation and the functional recovery. The objective of this project is to analyze the effect of muscle electrostimulation (ESM) on muscle weakness acquired in Intensive Care Unit (ICU) and its consequences. Study design: a single center, prospective, randomized trial to be held in the ICU of " Universitarian hospital La Fe" in collaboration with the service of Neurophysiology of the hospital. All patients undergoing sedation and mechanical ventilation (with an expected duration longer than 48h) and without any of the exclusion criteria detailed in the Methodology section will be included in the study. The intervention will consist of a muscular electrostimulation with the Super Pro Excel 70,UltratoneTM. The stimulation will be performed in 10 muscle groups (5 per side) following established protocols, at least 5 days a week. We will evaluate muscle strength by Medical Research Council scale, functional capacity by Barthel scale and Neurophaty Disability Scale, all clinical events will be collected and electrophysiologic, echographic and histologic parameters will be measured. The process of extubation will be performed following an established protocol, the duration will be collected as the same manner as ICU.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years.
* Sedated and mechanically ventilated critically ill patients, more than 48 hours.

Exclusion Criteria:

* Body mass index \> 45 or \< 20 kg/m2.
* Pregnant.
* Epilepsia.
* Use muscular blocks.

Primary outcomes:
measure: muscular weakness
timeFrame: at the time of weaning, 30 days after extubation and one year after extubation.
Secondary outcomes:
measure: time of weaning
timeFrame: everyday
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe.
Study officials:
References:
Clinical trial NCT05520957: Early SARS-CoV-2 Tracheostomy
Official title: Early Tracheostomy in COVID-19 Critically Ill Patients: A Retrospective Case Series
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tracheostomy
Characteristics Disease
Metabolic Disturbance
Keywords: COVID-19
tracheostomy
demographic
lactate
D-dimer
Lead sponsor: Cantonal Hospital Zenica
Sponsor class: OTHER
First posted: 2022-08-30
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We performed a retrospective review of all COVID-19 critically ill patients who underwent tracheotomy between 2020 and 2022. All tracheotomized patients were included in the analysis, age 18 and older.

Brief summary: Objective of this case series was to evaluate the characteristics of early COVID-19 tracheostomy and its effect on laboratory parameters. A series of 17 patients with COVID-19undergo surgical tracheostomy in our intensive care unit. Demographic parameters, duration indicators, and laboratory parameters before and after tracheostomy were analyzed in patients. Of the 17 patients, 4 were men and 13 women with a mean age of 59 years. The average length of total hospitalization were 12 days, the length of stay in intensive care were 10 days, the length of endotracheal intubation were 9 days, with the seventh day of tracheotomy. Neurological and thyroid diseases and withdrawal had a statistically significant difference (p \<0.05), with laboratory parameters without statistically difference. Critically ill COVID-19 patients undergoing early tracheostomy has a lower possibility of weaning from mechanical ventilation, and early tracheostomy itself has no significant effect on renal parameters, lactate and D-Dimer.


Eligibility criteria: Inclusion Criteria:

* COVID-19 postive patients
* surgery tracheostomy patients

Exclusion Criteria:

* trachestomy before admission in the ICU

Primary outcomes:
measure: Characteristics of tracheotomized COVID-19 patients
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zenica
country: Bosnia and Herzegovina
facility: Cantonal Hospital
Study officials:
References:
Clinical trial NCT04890457: Brain, Behavior and Endocrine Effects of Transcutaneous Vagus Nerve Stimulation
Official title: Transcutaneous Vagus Nerve Stimulation Promotes Oxytocin Release and Increases Fixations on Nose
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: Transcutaneous vagus nerve stimulation
Oxytocin release
Eye-tracking
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The main aim of the study is to investigate whether the transcutaneous vagus nerve stimulation(tVNS) promotes oxytocin release and the potential biomarkers of tVNS based on eye-tracking data

Detailed description: A randomized, single-blinded, sham-controlled, within-subject, crossover design will be employed in this study. In a randomized order, a total of 54 healthy subjects will receive transcutaneous vagus nerve stimulation via tragus and sham stimulation vis earlobe in the left ear (interval between these two stimulations will be 1 week). Eye-tracking and behavioral data will be collected before and after 30 minutes of stimulation, saliva samples will be collected before and after 30 minutes of stimulation, and the end of the experiment.

Some personal traits will be assessed using different kinds of questionnaires, such as the Autism Spectrum Quotient(ASQ), Social Responsiveness Scale(SRS), State-Trait Anxiety Inventory (STAI), Beck's Depression Inventory(BDI), and Toronto Alexithymia Scale (TAS-20).

Eligibility criteria: Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

* history of head injury;
* pregnant, menstruating, taking oral contraceptives;
* medical or psychiatric illness.

Primary outcomes:
measure: Oxytocin release
timeFrame: After 30 min tragus stimulation
Secondary outcomes:
measure: The relationship between oxytocin concentration and personal traits
timeFrame: through study completion, an average of half an year
measure: Pupil size
timeFrame: After 30 min tragus stimulation
Other outcomes:
Locations:
city: Chengdu
country: China
facility: University of Electronic Science and Technology of China
state: Sichuan
Study officials:
affiliation: University of Electronic Science and Technology of China
name: Keith Kendrick, Dr.
role: PRINCIPAL_INVESTIGATOR
References: