louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06866145: Dexmedetomidine Infusion in Either Total Intravenous Anesthesia or Inhalational Anesthesia to Improve Surgical Field Visibility in Endoscopic Sinus Surgery
Official title: Dexmedetomidine Infusion in Either Total Intravenous Anesthesia or Inhalational Anesthesia to Improve Surgical Field Visibility in Endoscopic Sinus Surgery
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Rhinosinusitis
Keywords: endoscopic sinus surgery , dexmedetomidine, surgical field visibility
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will be conducted at Menoufia University Hospitals

Brief summary: Dexmedetomidine Infusion in either Total Intravenous Anesthesia or Inhalational Anesthesia to Improve Surgical Field Visibility in Endoscopic Sinus Surgery


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) class I and II patients undergoing endoscopic sinus surgery in the age group from 18-50 years.

Exclusion Criteria:

* History of allergy to medications used in the study, refusal of patients to participate, hepatic or renal dysfunction, chronic pain condition, psychological and neurological disorders

Primary outcomes:
measure: Surgical field visibility
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Shibin Elkom
country: Egypt
facility: Menoufia university hospital
Study officials:
References:
Clinical trial NCT01919645: Effectiveness and Safety of Physical Exercises in the Improvement of the Sleep Quality. Regarding Rheumatoid Arthritis
Official title: Effectiveness and Safety of Physical Exercises in the Improvement of the Sleep Quality in Women With Rheumatoid Arthritis: A Randomized Clinical Trial Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis, Rheumatoid
Keywords: Rheumatoid Arthritis
Sleep Disorders
Polysomnography
Sleep Stages
Physical Exercise
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2013-08-09
Enrollment: 43
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Physical exercise programs are effective and safe for the improvement of the sleep efficiency in patients with Rheumatoid Arthritis.


Eligibility criteria: Inclusion Criteria:

• Women ages 35-65 years diagnosed with Rheumatoid Arthritis according with the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR)Criteria; Pittsburgh Sleep Quality Index ≥ 5; electrocardiogram test (ECG) at rest and at regular effort.

Exclusion Criteria:

* Patients with joint restrictions due to disease.
* Other rheumatoid-associated diseases (Fibromyalgia) with the exception of Osteoarthritis of low degree.
* Those who are uncontrollably hypertense, diabetic, with thyroidopathy and cardiorespiratory diseases which stop them from practicing exercises.
* Class II obesity (IMC ≥ 35 Kg/m2).
* Cognitive deficits.
* Depression.
* Patients not following the study rules such as exercise hours and / or time for the proposed program.
* Current physical exercise practitioner.
* Those undergoing medication treatment which would interfere sleep.
* Night shift workers who disrespect regular working schedule.

Primary outcomes:
measure: Improvement of sleep through a polysomnogram exam.
timeFrame: at baseline and at end-week 16
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Centro de Estudos em Psicobiologia e Exercício (CEPE) da Associação Fundo de Incentivo a Pesquisa (AFIP)
Study officials:
affiliation: Federal University of São Paulo
name: Andrea H Kayo, PHD student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02737345: Correlation of Hepatitis C, Alcoholic Liver Disease, and Renal Failure With Hyperfibrinolysis in Liver Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cirrhosis
Keywords: fibrinolysis
liver transplant
thromboelastometry
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2016-04-13
Enrollment: 54
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: Patients with liver failure who are on the liver transplant waiting list

Brief summary: 1. Further characterize the incidence of hyperfibrinolysis in cirrhotics
2. Correlate hyperfibrinolysis with

   1. hepatitis C
   2. alcoholic liver disease
   3. the subset of a\&b with renal failure with and without dialysis
3. Better describe the hyperfibrinolytic ROTEM profile in cirrhotics


Eligibility criteria: Inclusion Criteria:

* Be on the the liver transplant waiting list

Exclusion Criteria:

* liver failure without eligibility for transplant

Primary outcomes:
measure: The percentage of patients who exhibit fibrinolysis
timeFrame: Within 60 minutes of sample run time
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Scott Allen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05876845: A Clinical Trial to Assess the Effect of a Combined Pre-, Pro-, and Post-biotic Supplement on Gut and Metabolic Health
Official title: A Clinical Trial to Assess the Effect of a Combined Pre-, Pro-, and Post-biotic Supplement on Gut and Metabolic Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gut Health
Lead sponsor: Beekeeper's Naturals Inc
Sponsor class: INDUSTRY
First posted: 2023-05-26
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a virtual, single-arm clinical trial that will last 4-weeks. Participants will take the supplement daily and complete questionnaires at baseline, week 2, and week 4. Participants will provide photos of their face and stomach at baseline and week 4.

Gut health and associated health outcomes, including brain, skin, and immune function, will be evaluated at baseline and at each check-in. Likert scale responses will be statistically compared from baseline to each check-in. Participant responses on product feedback will be presented as % scores. Baseline and endline photos from each study part will be provided by participants.


Eligibility criteria: Inclusion Criteria:

* Men or women
* 18 years of age or older
* Experience at least one of the following symptoms: regular bloating/gas, irregular bowel movements, heartburn, or poor digestive health
* Generally healthy

Exclusion Criteria:

* Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
* Allergic to bees, bee products, poplar tree products, or balsam of Peru
* Anyone with known severe allergic reactions.
* Women who are pregnant, breastfeeding or attempting to become pregnant
* Unwilling to follow the study protocol.
* Has introduced any new forms of medication or supplements targeting gut health within the last 3 months
* Has taken antibiotics in the last 3 months

Primary outcomes:
measure: Change in participant-reported gastrointestinal symptoms [Time Frame: Baseline to 4 weeks]
timeFrame: 4 weeks
measure: Change in scores on the Gastrointestinal Symptom Rating Scale (GSRS) [Time Frame: Baseline to 4
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References:
Clinical trial NCT01151345: Bioequivalence Study Of Diltiazem In 60 Mg Tablets As Tilazem 60® Made by Pfizer, S.A. De C.V., Versus Angiotrofin® 60 Mg Made by Amstrong Laboratorios De Mexico, S.A. De C.V.
Official title: Bioequivalence Study Of Diltiazem In 60 Mg Tablets As Tilazem 60® Made By Pfizer, S.A. DE C.V., Versus Angiotrofin® 60 Mg Made By Amstrong Laboratorios De Mexico, S.A. DE C.V. Study In 26 Healthy Volunteers Of Both Genders Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: diltiazem
angiotrofin
bioequivalence
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-06-28
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study will research the existance of actual bioequivalence between Diltiazem in 60 Mg Tablets As Tilazem 60® Made by Pfizer, S.A. DE C.V., Versus Angiotrofin® 60 Mg Made by Amstrong Laboratorios De Mexico, S.A. DE C.V.

Detailed description: Bioequivalence of this particular drug

Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Both genders
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 or ± 10% variation of the ideal weight; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug screen

Primary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
timeFrame: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dose
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]
timeFrame: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dose
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dose
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: DF
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05819645: Oral Fluid Intake After Extubation
Official title: Early Versus Delayed Oral Fluid Intake Initiation (Sipping) After Extubation, Influence on the Feeling of Thirst, Patient Comfort and the Occurrence of Complications.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation
Lead sponsor: University Hospital, Motol
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: According to the current guidelines the patient is not allowed to drink any fluid at least 2 hours after extubation to prevent complications. However there is no evidence in the literature to support this approach. Because anaesthetic drugs and their side effects changed significantly from their first usage, the investigators can assume that existing approach is obsolete and has no place anymore in the modern medicine. Keeping patient n.p.o (nothing per os) for 2 hours after extubation may lead to patient´s thirst or other discomfort. The aim of the study is to detect whether early oral fluid intake after extubation could lead to safe relief of thirst and to better patient´s comfort overall.

Detailed description: Everything stated in the brief summary.

Eligibility criteria: Inclusion Criteria:

* patients with planned extubation assigned to the study
* able to swallow the fluid
* willing to participate the study

Exclusion Criteria:

* patients after upper digestive tract surgery
* patients after trachea surgery
* patients with possible neurological deficiency
* patients after VIII. cranial nerve surgery
* patients not able to swallow

Primary outcomes:
measure: Assessment of presence or absence of thirst 120 minutes after extubation
timeFrame: During procedure (120 minutes after extubation)
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: University Hospital Motol, Charles University in Prague
state: Czech Republic
Study officials:
References:
Clinical trial NCT01619345: Pharmacoscintigraphic Investigation of NN9924 in Healthy Male Subjects
Official title: Pharmacoscintigraphic Investigation NN9924 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-06-14
Enrollment: 27
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to investigate whether the volume of water administered with NN9924 affects the anatomical location (stomach or proximal small bowel) of tablet erosion.


Eligibility criteria: Inclusion Criteria:

* Good general health
* Body mass index (BMI) of 18.5-30.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Males who are not willing to use two acceptable forms of highly effective contraception
* Participation in another clinical trial within 90 days
* Any chronic disorder or severe disease
* Use of GLP-1 (glucagon-like peptide-1) agonists within 3 months preceding dosing
* Subjects who are smokers
* Subjects who have donated any blood or plasma in the past month or in excess of 500 mL within the 12 weeks preceding screening

Primary outcomes:
measure: Anatomical location (stomach or proximal small bowel) of tablet at complete tablet erosion (CTE)
timeFrame: Assessed 0-4 hours post dose
Secondary outcomes:
measure: Area under the NN9924 concentration curve
timeFrame: From time 0-24 hours
measure: Anatomical location of initial tablet erosion (ITE)
timeFrame: Assessed 0-4 hours post dose
measure: Time to ITE
timeFrame: Assessed 0-4 hours post dose
measure: Time to CTE
timeFrame: Assessed 0-4 hours post dose
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03688945: Art in Improving Outcomes in Participants Undergo Surgery
Official title: Art Heals - (the Effects of Art After Robot Assisted Surgery)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Health Status Unknown
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This trial studies how well art works in improving outcomes in participants who are undergoing surgery. Exposure to art may help to improve clinical and psychological outcomes.

Detailed description: PRIMARY OBJECTIVES:

I. Investigate through evidence-based randomized controlled trial the effect of exposure to art during the perioperative period on the outcome of surgical outcomes II. Assess patient response to artwork and investigate the correlation of patient response with the clinical outcomes of the patients.

III. Measure cognitive changes that may occur for patients based on art exposure.

OUTLINE: Participants are randomized into 1 of 2 arms.

ARM I: Participants attend at least 2 sessions of viewing art pieces over 15 minutes every day for 2 years.

ARM II: Participants receive standard of care for 2 years.

Eligibility criteria: Inclusion Criteria:

* Ambulant inpatients that will stay for at least 2 days postoperatively and do not require continuous monitoring
* All races and ethnic groups are eligible for this study

Exclusion Criteria:

* Patients with altered mental status, psychiatric illness, debilitating pain, blind patients, or those who require continuous monitoring postoperatively will be excluded from the study
* Adult unable to consent, individuals who are not yet adults, pregnant women or prisoners

Primary outcomes:
measure: Mental health wellbeing score
timeFrame: Up to 2 years
Secondary outcomes:
measure: Reduced pain: NRS
timeFrame: Up to 2 years
measure: Anxiety score (patient)
timeFrame: Up to 2 years
measure: Hope score
timeFrame: Up to 2 years
measure: Change in blood pressure
timeFrame: Up to 2 years
measure: change in recovery of bowel function
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Khurshid Guru
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05494645: Exparel Use in Peripheral Nerve Blocks and Local Infiltration for Foot and Ankle Surgery: A Randomized Controlled Trial
Official title: Exparel Use in Peripheral Nerve Blocks and Local Infiltration for Foot and Ankle Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain, Postoperative
Pain, Acute Postoperative
Ankle Fractures
Ankle Injuries and Disorders
Keywords: liposomal bupivacaine
ankle surgery
postoperative pain
regional nerve block
Lead sponsor: St. Luke's Hospital, Pennsylvania
Sponsor class: OTHER
First posted: 2022-08-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Liposomal Bupivacaine (Exparel) has been recently studied as the active agent utilized in various nerve block. Due to its liposomal form allowing for extended delivery, Exparel has been used in various peri-operative nerve blocks among multiple orthopaedic specialties in hopes of achieving improved pain control and decreased opioid use. This study compares the efficacy and effect on opioid use of peripheral nerve blocks and local infiltration with and without Exparel in patients undergoing foot and ankle surgery.

Detailed description: three study groups: A - surgeon infiltrates with exparel on site of surgery; B - anesthesia provides a regional nerve block (popliteal/adductor blocks) with plain local anesthetic (bupivacaine); C - anesthesia provides a regional nerve block (popliteal/adductor) with Exparel/bupivacaine mix. Follow up occurs on postop day 4 via phone call to patient. Measured outcomes include opioid consumption in post anesthesia care unit phase (oral morphine equivalents), block duration, number of opioid pills used by postop day 4, oral morphine equivalent consumption by postop day 4.

Eligibility criteria: Inclusion Criteria:

* Adult patients undergoing elective orthopaedic foot and ankle surgery at a single institution
* English speaking
* Able to provide consent to surgery and study participation

Exclusion Criteria:

* Non-elective or emergent foot and ankle surgery
* Non-english speaking
* Does not possess medical decision making capacity

Primary outcomes:
measure: Duration of block
timeFrame: 3 Months
Secondary outcomes:
measure: number of opioid pills used by postoperative day # 4
timeFrame: 3 months
measure: PROMIS Scores
timeFrame: 3 months
measure: oral morphine equivalent use by postoperative day 4
timeFrame: 3 months
Other outcomes:
Locations:
city: Bethlehem
country: United States
facility: St. Luke's University Health Network
state: Pennsylvania
Study officials:
affiliation: St. Luke's Hospital and Health Network, Pennsylvania
name: Anna Ng-Pellegrino
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05801445: Increasing Movement and Exercise in Geriatric Patients Through Large-Scaled Creative Occupation Interventions
Official title: Increasing Movement and Exercise in Geriatric Patients Through Large-Scaled Creative Occupation Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Fitness in Older Adults
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 14
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare two different types of activities in improving physical fitness in older adults. The main question it aims to answer is whether a person completing a large-scaled art project has similar physical improvements as a person completing a more traditional exercise program.

Participants will be asked to either stand for up to an hour while completing a painting across a large canvas or stand for up to an hour while doing body weight exercises. Researchers will compare the painting group to the exercise group to see if physical improvements are the same or different.

Detailed description: The purpose of this study is to determine whether large-scaled creative occupations, such as painting large paintings, would be equally, if not more beneficial than traditional exercise for older adults. Painting on large mural-sized paintings will simulate the participation of endurance heavy, physically demanding tasks. This is because to complete the task, participants will be required to reach to cover the canvas, stand for extended periods of time, and perform repetitive movements. It is hypothesized that this activity will increase active range of motion, strength, endurance, balance, as well as motivation to participate in physical activity by providing a more enjoyable, alternative form of exercise.

Eligibility criteria: Exclusion Criteria:

* Individuals unable to stand with minimal support

Primary outcomes:
measure: Upper extremity active range of motion
timeFrame: 10 weeks
measure: Upper and lower extremity strength
timeFrame: 10 weeks
measure: Standing balance
timeFrame: 10 weeks
Secondary outcomes:
measure: Self-motivation
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Citronelle
country: United States
facility: Crowne Health Services
state: Alabama
Study officials:
References: