louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06486805: N-acetyl Cysteine Effect on Liver Function After Mitral Valve Replacement
Official title: The Effect of N-Acetylcysteine on Liver Functions After Mitral Valve Replacement: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Oxidative Stress
Liver Dysfunction
Keywords: MDA
liver function
N-acetylcystien
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study
Primary purpose: PREVENTION

Brief summary: This study aimed at the impact of the N-acetyl cysteine on the improvement of liver function subsequently on-pum mitral valve replacement. Following a clinical trial design, 34 candidates of on-pump MVR, aged 30 to 70 years, with normal liver and renal function were selected. The candidates were randomly divided into intervention: IV150 mg/ kg N-acetyl cysteine over 15 min, and control groups (normal saline as placebo) (n = 17 in each group).

Detailed description: In a randomized controlled prospective study in a teaching hospital after approval of the ethical committee and informed consent 34 candidates of on-pump MVR, aged 30 to 70 years, with normal liver and renal function were selected. The candidates were randomly divided into intervention: IV150 mg/ kg N-acetyl cysteine over 15 min then 50 mg/kg over 4 hrs, and control groups (normal saline as placebo) (n = 17 in each group).and we will assess the effect of NAC on intra-operative hemodynamics and post-operative its protective rule against oxidative stress and liver dysfunction.

Eligibility criteria: Inclusion Criteria:

* Age from30 to 65 years
* Both sexes
* Patients undergoing on-pump elective MVR with cold cardioplegia.

Exclusion Criteria:

* • Patient refusal.

  * Allergy to any of the study medications.
  * Emergency procedures.
  * systolic dysfunction left ventricular ejection fraction \<40%.
  * Pre-existing hepatic dysfunction, as evident by elevated liver enzymes and bilirubin which is defined as an increase in liver enzymes AST and ALT \>10 times of baseline.
  * Patients on chronic use of drugs that might affect liver functions, e.g. NSAID, steroids, and anticonvulsants.

Primary outcomes:
measure: Malondialdahyde (MDA)
timeFrame: first postoperative day
Secondary outcomes:
measure: MDA
timeFrame: preoperative and second postoperative day
measure: liver function tests
timeFrame: preoperative ,first ,and,second post operative days
measure: hemodunamics
timeFrame: intraoperative
measure: extubation time
timeFrame: postoperative 24 hr.
measure: tissue perfusion
timeFrame: preoperative ,first ,and,second post operative days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasralainy Faculty of Medicine
Study officials:
References:
Clinical trial NCT02753205: Dexmedetomidine on Optic Nerve Sheath Diameter
Official title: Effect of Dexmedetomidine on Optic Nerve Sheath Diameter During Laparoscopic Anterior Resection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Intracranial Hypertension
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2016-04-27
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Dexmedetomidine, might attenuate the sympathetic activation and contribute to stable hemodynamics. The investigator hypothesized that continuous infusion of dexmedetomidine during laparoscopic lower abdominal surgery, might help to attenuate the increment of intracranial pressure and the investigator would observe the optic nerve sheath diameter using ultrasonography.

Detailed description: Laparoscopic lower abdominal surgery requires the Trendelenburg position with pneumoperitoneum for a prolonged time, but this can cause significant increase in intracranial pressure. Dexmedetomidine, a selective alpha2 receptor agonist might attenuate the sympathetic activation and contribute to stable hemodynamics. The investigator hypothesized that continuous infusion of dexmedetomidine during laparoscopic lower abdominal surgery, might help to attenuate the increment of intracranial pressure and the investigator would observe the optic nerve sheath diameter using ultrasonography.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of colorectal cancer
* planed for laparoscopic low anterior resection

Exclusion Criteria:

* morbid obesity (body mass index \> 30 kg.m-2)
* history of cerebrovascular disease
* history of respiratory disease
* uncontrolled cardiovascular disease

Primary outcomes:
measure: Optic nerve sheath diameter
timeFrame: Change from Baseline optic nerve sheath diameter at pneumoperitoneum 30 min
Secondary outcomes:
measure: Respiratory and mean arterial pressure
timeFrame: Change from Baseline Respiratory and mean arterial pressure at pneumoperitoneum 30 min
Other outcomes:
Locations:
Study officials:
affiliation: Gachon Universtiy Gil Medical Center
name: Kyung Cheon Lee
role: STUDY_CHAIR
References:
Clinical trial NCT04924205: A Comparison Of Primary TKA Rehabilitation Using A Smart Orthotic Versus Outpatient Physical Therapy
Official title: A Prospective Comparison Of Primary Total Knee Arthroplasty Rehabilitation Using A Smart Orthotic Versus Outpatient Physical Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arthropathy of Knee
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2021-06-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This will be a prospective, randomized, noninferiority clinical trial comparing rehabilitation methods post-total knee arthroplasty (TKA). Population of interest is adult hip/knee clinic patients over age 18 who are indicated for unilateral primary total knee arthroplasty. All TKA patients are prescribed physical therapy (PT) for rehabilitation post-operatively. The investigators will compare this current treatment with a new, validated, wearable smart knee brace (FM2 Knee Brace) that can be used for rehabilitation post-TKA. Following enrollment in the study, the investigators will match and randomize participants into two cohorts (outpatient PT versus FM2 Knee Brace). Outpatient PT group will be prescribed routine six-week course of outpatient PT (no pool exercises, remainder at therapist's discretion) to start as soon as possible upon discharge. The FM2 Knee Brace group will complete device set up at pre-op visit and will be prescribed 3-4 exercises to complete at their discretion over six weeks. The investigators will collect measurements of knee flexion, extension, total arc of motion at pre-op visit and at 6-week, 3-month, and 1-year post-op visits. The investigators will also plan to record additional PROs, therapy compliance, and complication rates. The investigators will compare the two groups to test whether the new FM2 Knee Brace is noninferior to regular PT when recovering from TKA, and if the new technology could be an alternative to outpatient PT.


Eligibility criteria: Inclusion Criteria:

* Ages 18-100
* Indicated for primary total knee arthroplasty
* Possess a smartphone with capabilities to use the FocusMotion app and FM2 Knee Brace
* Home discharge post-operatively

Exclusion Criteria:

* Prior ipsilateral knee surgery
* Prior manipulation under anesthesia of either knee
* BMI \> 40

Primary outcomes:
measure: Range of Motion
timeFrame: pre-surgery
measure: Range of Motion
timeFrame: 6 weeks post-surgery
measure: Range of Motion
timeFrame: 3 months post-surgery
measure: Range of Motion
timeFrame: 1 year post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
Study officials:
References:
Clinical trial NCT00990405: Clinical Study to Evaluate the Efficacy and the Safety of Eradication Therapy for Helicobacter Pylori in Functional Dyspepsia
Official title: Phase 4 Study of Helicobacter Pylori Eradication Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Functional Dyspepsia
Helicobacter Pylori Infection
Keywords: Rome III criteria
Lead sponsor: Korean College of Helicobacter and Upper Gastrointestinal Research
Sponsor class: OTHER
First posted: 2009-10-06
Enrollment: 400
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The role of Helicobacter pylori infection in functional dyspepsia remains controversial. Several randomized controlled trials in western countries have shown no significant advantage over placebo. But some recent studies in Asian population were different compared to the result of studies in the Western population. At the present time, it seems to be difficult to conclude the efficacy of the H.pylori eradication therapy in patients with H. pylori-infected functional dyspepsia.

The investigators hypothesize that eradication of Helicobacter pylori has a sustained global symptom improvement in patients with H. pylori infected functional dyspepsia.

Detailed description: Functional dyspepsia: diagnosed by Rome III criteria of Functional gastrointestinal disorder Treatment regimen: Combination of proton pump inhibitor, Amoxicillin, Clarithromycin for 7 days Placebo: Same shaped placebo drugs

Eligibility criteria: Inclusion Criteria:

* Functional dyspepsia by Rome III criteria
* Normal endoscopic findings
* H. pylori positive by Urea breath test

Exclusion Criteria:

* Patients with severe concomitant systemic disease
* Patients with GI surgery
* Females with pregnancy or breast-feeding
* Irritable bowel syndrome, inflammatory bowel disease
* Duodenal Ulcer, Gastric Ulcer, GI bleeding
* History of eradication therapy of Helicobacter pylori
* Malignancy
* Psychosomatic disease

Primary outcomes:
measure: Global symptom improvement after eradication of Helicobacter pylori in patients with functional dyspepsia therapy)
timeFrame: Symptom assessment at 8 weeks after eradication
Secondary outcomes:
measure: To improves the quality of life
timeFrame: 1 year
measure: Global symptom improvement, at 4 weeks after Helicobacter pylori eradication therapy
timeFrame: 1 year
measure: The improvement of 8 dyspeptic symptom
timeFrame: 1 year
measure: The adequate relief of symptom
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korean Society of Helicobacter and Upper GI Research
Study officials:
affiliation: Korean Society of Helicobacter and Upper Gastrointestinal Research
name: Sang-Young Seol, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT05488405: Mesalazine Oral Suspension in Active Eosinophilic Esophagitis
Official title: Open-label, Monocentric Phase IIa Pilot Study Evaluating the Efficacy and Tolerability of a 4-week Treatment With Mesalazine Oral Suspension in Patients With Active Eosinophilic Esophagitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Eosinophilic Esophagitis
Keywords: Esophageal dysfunction, esophageal inflammation
Lead sponsor: Dr. Falk Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2022-08-04
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pilot study to assess a mesalazine oral suspension in active eosinophilic esophagitis

Detailed description: This is an open-label, monocentric exploratory phase IIa pilot study, which serves to evaluate the efficacy, safety, and tolerability of treatment with mesalazine oral suspension for the treatment of active eosinophilic esophagitis (EoE).

Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Male or female patients, 18 to 75 years of age
* Confirmed clinico-pathological diagnosis of eosinophilic esophagitis (EoE) according to established diagnostic criteria
* Negative pregnancy test in females of childbearing potential

Exclusion Criteria:

* Other causes for esophageal eosinophilia
* Clinical and endoscopic signs of gastroesophageal reflux disease (GERD)
* Any concomitant esophageal disease and relevant gastro-intestinal disease (celiac disease, inflammatory bowel disease, oropharyngeal or esophageal bacterial, viral, or fungal infection \[candida esophagitis\])
* Any known or suspicion for relevant infectious diseases associated with clinical signs,
* Known intolerance/hypersensitivity/resistance to the IMP or excipients or drugs of similar chemical structure or pharmacological profile
* Existing or intended pregnancy or breast-feeding

Primary outcomes:
measure: Proportion of patients with histological remission
timeFrame: 4 weeks
Secondary outcomes:
measure: Proportion of patients with histological response
timeFrame: 4 weeks
measure: Proportion of patients with improvement of symptoms
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
Study officials:
affiliation: UniversitätsSpital Zürich Klinik für Gastroenterologie und Hepatologie
name: Luc Biedermann, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04470505: Optimizing Platelet Isolation (The Cell Study)
Official title: Optimizing Platelet Isolation for Measures of Human Platelet Mitochondrial Respiration (The Cell Study)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Healthy
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2020-07-14
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 25-35 years old

Brief summary: The research study is about blood cells (platelets) and their power houses (mitochondria). The investigators want to learn about their behavior in order to ensure that our laboratory procedures are generating optimal results.

Detailed description: The objectives of this study are to assess platelet activation following standard laboratory procedures used in the process of measuring platelet mitochondrial function, and to determine the optimal amount of digitonin needed to permeabilize platelet cell membrane.

Eligibility criteria: Inclusion Criteria:

* Age 25-35
* All races
* All ethnicity
* 18.5 - 30 BMI

Exclusion Criteria:

* smoking
* Aspirin intake
* Recreational drug use
* Alcohol intake more than 3 times per week
* Self-reported possibility of current pregnancy
* Known diagnosis of:
* Pre-diabetes
* Diabetes
* High cholesterol
* High triglycerides
* Hypertension
* Anemia
* Autism spectrum disorder
* Attention deficit hyperactivity disorder (ADHD)
* Attention deficit disorder (ADD)
* Severe asthma
* Refusal to stop taking nutritional supplements
* Any other pre-existing medical condition that requires daily medication as determined by the investigators to affect outcome of interest

Primary outcomes:
measure: Platelet activation from isolated platelets
timeFrame: day 1
Secondary outcomes:
measure: Platelet activation measured in whole blood
timeFrame: day 1
measure: Platelet reactivity measured in whole blood
timeFrame: day 1
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
Study officials:
References:
Clinical trial NCT04044105: Impacting the Disposal of Unused Opioid
Official title: Impacting the Disposal of Unused Opioid Analgesics Through Education in the Orthopaedic Population: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use and Disposal
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2019-08-05
Enrollment: 563
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to compare the rates of proper opioid disposal in patients receiving an educational brochure compared to an automated text message delivered directly to patients' cell phones alongside the brochure, compared to no education on the subject.

Detailed description: Opioids are used to treat acute pain after surgery, but can lead to misuse and abuse. Very few patients properly dispose of unused opioids and the majority of opioids are stored in the home in unlocked containers as opposed to being properly disposed of. Improper disposal of opioid medications is a concern due to the potential for nonmedical use and has the potential to cause injury or death for patients and their family members that can access the medications. The purpose of this study is to compare the rates of proper opioid disposal in patients receiving an educational brochure compared to an automated text message delivered directly to patients' cell phones alongside the brochure, compared to no education on the subject. There is evidence that an educational brochure significantly increases proper disposal rates, albeit only to about 25%. The goal of this study is to evaluate the impact of an educational pamphlet on proper opioid disposal in the total joint arthoplasty population, and to see if the addition of a text messaging system can increase further increase proper disposal rates.

Eligibility criteria: Inclusion Criteria:

* Any patient undergoing primary total hip or knee arthroplasty
* Age ≥18 years old

Exclusion Criteria:

* Patients allergic to oxycodone
* Patients consuming opioids during the 4 weeks prior to surgery
* Patients with a history of opioid dependence
* Patients undergoing revision total knee or hip arthroplasty
* Non-English speaking patients
* Age \<18 years old

Primary outcomes:
measure: Disposal rates
timeFrame: 6 weeks after surgery
Secondary outcomes:
measure: Continued taking opiate rate
timeFrame: 6 weeks after surgery
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush
name: Craig Della Valle, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03754205: Vaginal CO2 Laser and the Genitourinary Syndrome of Menopause
Official title: The Clinical, Histopathological, Cytological and Microbiological Efficacy of the Micro-ablative Fractional CO2 Laser : A Double-blind Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vaginal Atrophy
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
Collaborators: name: IRCCS San Raffaele
First posted: 2018-11-27
Enrollment: 60
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the clinical, histopathological, cytological and microbiological efficacy of Microablative Fractional CO2 laser intravaginally administered in postmenopausal women with Genitourinary Syndrome of Menopause. Half participants will receive active CO2 laser therapy, while the other half will receive placebo CO2 laser therapy.


Eligibility criteria: Inclusion Criteria:

* Symptoms of vaginal atrophy (dyspareunia and/or vaginal dryness)
* Menopause

Exclusion Criteria:

* Systemic or local hormonal therapy the last 6 months
* Use of moisturizers or lubricants the last month
* Active genital infection (i.e herpes, vaginitis)
* Prolapse stage \>=2
* Underlying pathologies that could interfere with the protocol compliance

Primary outcomes:
measure: 10-centimeter Visual Analogue Scale assessing intensity of dyspareunia and dryness
timeFrame: 24-months
Secondary outcomes:
measure: Day-to Day Impact of vaginal aging questionnaire (DIVA)
timeFrame: 24 months
measure: Patients Global Impression of Improvement
timeFrame: 24 months
measure: 10-centimeter Visual Analogue Scale assessing intensity of itching, burning and dysuria
timeFrame: 24 months
measure: 3 days voiding diary
timeFrame: 24 months
measure: Female Sexual Function Index
timeFrame: 24 months
measure: International Consultation on Incontinence Questionnaire Short Form/Female Lower Urinary tract Symptoms (ICIQ-FLUTS)
timeFrame: 24 months
measure: King's Health Questionnaire (KHQ)
timeFrame: 24 months
measure: Vaginal Maturation Value
timeFrame: 24 months
measure: Vaginal Health Index Score
timeFrame: 24 months
measure: Epithelial thickness
timeFrame: 24 months
measure: Number of Blood vessels
timeFrame: 24 months
measure: Size of blood vessels
timeFrame: 24 months
measure: Density of blood vessels
timeFrame: 24 months
measure: Cultures of vaginal samples
timeFrame: 24 months
measure: Polymerase Chain Reaction
timeFrame: 24 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Urogynecological Unit of Alexandra Hospital
Study officials:
affiliation: National and Kapodistrian University of Athens, Greece
name: Stavros Athanasiou, Associate Proffesor
role: PRINCIPAL_INVESTIGATOR
References: