louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06622278: Flipped Classroom for Weight Management
Official title: Flipped Classroom for Weight Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Weight Loss
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 18
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: This study is a 24-week, single-arm trial investigating the feasibility of a flipped classroom behavioral intervention for weight management. The investigators will recruit up to 30 adults ages 18+ with a body mass index greater than or equal to 25 kg/m2 to participate in weekly, 1-hour group weight management education delivered remotely via Zoom with a trained health educator. Participants will receive a dietary prescription of 1200-1500 calories/day (5 portion-controlled meals and 5+ servings of fruits and vegetables) and exercise prescription of 150-300 minutes exercise/week. Additionally, participants will be asked to self-monitor diet and exercise adherence weekly. Feasibility outcomes will be collected at baseline, 12-weeks, and 24-weeks.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index greater than or equal to 25
* Age 18 to 75 years
* Wireless internet connection in the home
* Ability to engage in moderate to vigorous intensity exercise

Exclusion Criteria:

* Unable to commit to weekly group education
* Food allergy/intolerance that would hinder ability to adhere to dietary prescription

Primary outcomes:
measure: Attendance
timeFrame: 24 weeks
measure: Attrition
timeFrame: 24 weeks
Secondary outcomes:
measure: Weight
timeFrame: 24 weeks
measure: Height
timeFrame: 24 weeks
measure: Body Mass Index
timeFrame: 24 weeks
measure: Diet Adherence
timeFrame: 24 weeks
measure: Exercise Adherence
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
References:
Clinical trial NCT06970678: Combining Dexmedetomidine Infusion and Paragastric Autonomic Neural Block to Enhance Postoperative Recovery in Patients Undergoing Laparoscopic Sleeve Gastrectomy
Official title: Efficacy of Dexmedetomidine Infusion Combined With Paragastric Neural Block in Enhancing Postoperative Recovery Following Laparoscopic Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Laparoscopic Sleeve Gastrectomy (LSG)
Keywords: dexmedetomidine infusion
laparoscopic sleeve gastrectomy (LSG)
paragastric neural block
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if combining Dexmedetomidine infusion and paragastric autonomic neural block will enhance the postoperative recovery of patients undergoing laparoscopic sleeve gastrectomy. The main questions it aims to answer are:

Will combining the two techniques (Dexmedetomidine infusion and paragastric autonomic neural block) improve the quality of recovery? Will opioid consumption postoperatively decrease after combining those two techniques? Will the patients be able to start mobilizing sooner after surgery? Will the patient encounter less incidence of nausea and vomiting?

Researchers will asses the quality of the patients' recovery by reviewing the Quality of recovery 40 (QoR 40) questionnaire filled by the patients, assessing hemodynamic parameters intra- and postoperatively, recording the opioids consumed by the patients in the postoperative period, recording the time to first mobilization of the patient, and recording the incidence of nausea and vomiting.


Eligibility criteria: Inclusion Criteria:

1. ASA II-III
2. 18-60 years
3. BMI of 35-50 kg/m²

Exclusion Criteria:

1. Patients with chronic pain disorders
2. Patients using gabapentin, chronic opioid users
3. Patients on anticoagulant therapy
4. Patients with history of upper gastrointestinal system surgery
5. Patients with liver, kidney, cardiovascular diseases
6. Patients with allergy to dexmedetomidine or bupivacaine

Primary outcomes:
measure: Patient Satisfaction
timeFrame: Postoperative day 1
Secondary outcomes:
measure: Baseline Demographics
timeFrame: preoperative
measure: Heart Rate
timeFrame: Heart rate will be recorded prior to induction, post-induction, after the loading dose of dexmedetomidine, 4 hours and 12 hours postoperatively.
measure: Blood Pressure
timeFrame: Blood pressure will be recorded prior to induction, post-induction, after the loading dose of dexmedetomidine, 4 hours, and 12 hours postoperatively.
measure: Opioid consumption
timeFrame: at 4, 8, 12 hours postoperative
measure: Time to mobilize
timeFrame: Immediately postoperatively (in minutes)
measure: Incidence of nausea and vomiting
timeFrame: Postoperative day 1
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Main University Hospital
Study officials:
References:
Clinical trial NCT06587178: Semi-elemental Versus Polymeric EEN in the Preoperative Optimization for Patients with CD
Official title: Semi-elemental Versus Polymeric Exclusive Enteral Nutrition in the Preoperative Optimization for Patients with Crohn's Disease: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Crohn Disease
Nutrition Disorders
Surgery
Keywords: Crohn's disease
Exclusive enteral nutrition
surgery
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Growing evidence has shown that exclusive enteral nutrition (EEN) plays an important role in the preoperative optimization for patients with Crohn's disease (CD). However, the efficacy and safety of different types of enteral feeds including semi-elemental and polymeric enteral nutrition on CD have not been investigated. The aim of this study was to compare the role of semi-elemental and polymeric enteral nutrition on CD.

Detailed description: Growing evidence has shown that exclusive enteral nutrition (EEN) plays an important role in the preoperative optimization for patients with Crohn's disease (CD). However, the efficacy and safety of different types of enteral feeds including semi-elemental and polymeric enteral nutrition on CD have not been investigated. The aim of this study was to compare the role of semi-elemental and polymeric enteral nutrition on CD. The primary outcome: the reduction rate of CRP/ALB after exclusive enteral nutrition in Crohn's disease. The other outcomes: (1) the changes in Crohn's disease activity index; (2) the tolerance of enteral nutrition; (3) the changes in body mass index; (4) postoperative complications and the incidence of stoma; (5) the rate of surgery; (6) other adverse reactions.

Eligibility criteria: Inclusion Criteria:

1. elective bowel resection for Crohn's disease;
2. preoperative diagnosis of Crohn's disease;
3. age between 18 to 65 years old;
4. malnutrition;
5. the Crohn's disease activity index over 150;
6. nasal feeding.

Exclusion Criteria:

1. emergency surgery;
2. preoperative exclusive enteral nutrition before three months;
3. can not tolerate enteral nutrition;
4. less than 6 weeks of exclusive enteral nutrition;
5. preoperative corticosteroids within 3 months;
6. history of gastrointestinal surgery;
7. isolated colon disease;
8. metabolic disease (diabetes, hyperthyroidism).

Primary outcomes:
measure: The change of CRP/ALB level
timeFrame: 6 weeks
Secondary outcomes:
measure: BMI
timeFrame: 6 weeks
measure: CDAI
timeFrame: 6 weeks
measure: postoperative complications
timeFrame: 6 weeks
measure: adverse reaction
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Wei Zhou
state: Zhejiang
Study officials:
affiliation: Sir Run Run Shaw Hospital
name: Xiujun Cai
role: STUDY_CHAIR
References:
Clinical trial NCT02154178: Fungal Biomarkers to Reduce Duration of Empirical Antifungal Therapy: a Randomized Comparative Study (STAFE)
Official title: Fungal Biomarkers to Reduce Duration of Empirical Antifungal Therapy: a Randomized Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fungal Infection
Critical Illness
Keywords: empiric antifungal therapy
biomarkers
invasive fungal infection
Candida
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2014-06-03
Enrollment: 110
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 investigators hypothesized that the use of biomarkers of invasive fungal infections would increase the percentage of early discontinuation of empirical antifungal therapy and thus reduce the duration of treatment in ICU patients.

Detailed description: The duration of empirical/preemptive anti fungal treatment will be based in the intervention group on biomarker results.

Biomarkers of fungal disease will performed before starting anti fungal treatment and at day 4.

Eligibility criteria: Inclusion Criteria:

* Age \> or = 18 years
* Patients requiring empiric antifungal therapy the first time in the ICU
* Predictable duration of hospitalization in the ICU ≥ 6 days

Exclusion Criteria:

* Neutropenia (WBC \<1000 or neutrophils \<500/mm3)
* Immunosuppressive therapy (chemotherapy within 3 months prior to the ICU admission, solid organ graft under immunosuppressive therapy)
* invasive fungal infection documented in the three previous months
* Antifungal treatment in the three previous months
* Pregnant or lactating women

Primary outcomes:
measure: percentage of early discontinuation of empiric antifungal therapy
timeFrame: 7 days
Secondary outcomes:
measure: mortality in ICU
timeFrame: 28 days after ICU admission
measure: duration of mechanical ventilation and ICU stay
timeFrame: 28 days after ICU admission
measure: fungal colonization / infection after antifungal therapy, with or without resistant strains
timeFrame: 28 days after ICU admission
measure: the cost of the antifungal therapy on a per duration prescribe
timeFrame: 28 days after ICU admission
measure: the cost of hospital stays
timeFrame: 28 days after ICU admission
Other outcomes:
Locations:
city: Lille
country: France
facility: ICU, Salengro Hospital, University Hospital of Lille
state: Nord
Study officials:
affiliation: Univ Hosp of Lille, France
name: Saad Nseir, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rouze A, Loridant S, Poissy J, Dervaux B, Sendid B, Cornu M, Nseir S; S-TAFE study group. Biomarker-based strategy for early discontinuation of empirical antifungal treatment in critically ill patients: a randomized controlled trial. Intensive Care Med. 2017 Nov;43(11):1668-1677. doi: 10.1007/s00134-017-4932-8. Epub 2017 Sep 22.
Clinical trial NCT02640378: Semiquantitative Urine Pregnancy Test Results At ≥9 Weeks of Gestation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2015-12-28
Enrollment: 122
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women at \>9 weeks gestation

Brief summary: Purpose of study is to obtain data on urinary HCG concentrations at \>9 weeks of gestation.


Eligibility criteria: Inclusion Criteria:

* pregnant at \>9 weeks of gestation

Exclusion Criteria:

* none

Primary outcomes:
measure: Urine HCG concentration
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Gynuity Health Projects
name: Elizabeth Raymond
role: STUDY_DIRECTOR
References:
Clinical trial NCT04932278: The Role of Osteopathic Manipulative Medicine in Recovery From Concussions
Official title: The Role of Osteopathic Manipulative Medicine in Recovery From Concussions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Concussion, Brain
Keywords: concussion
Sport-related
Osteopathic manipulative treatment
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: American Osteopathic Association
First posted: 2021-06-21
Enrollment: 76
Sex: ALL
Minimum age (years): 13
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: For this study, participants will be randomly assigned to 1. Usual care, or 2. Usual care and OMT.
Primary purpose: TREATMENT

Brief summary: This project aims to study whether adding osteopathic manipulative treatment (OMT) to usual care of concussed patients will enhance their recovery.


Eligibility criteria: Inclusion Criteria:

* Age between 13-55 years
* Concussion sustained within the last 12 days

Exclusion Criteria:

* Contraindications to OMT, such as skull fracture, cervical fracture, signs of intracranial bleeding, or stroke
* Neck surgery within the last 6 months
* Any conditions recognized by a physician as contraindicating or impeding protocol implementation
* Will not be under the care of a healthcare professional
* Any active (or pending) worker's compensation, disability, or personal injury claims related to their concussion injury

Primary outcomes:
measure: SCAT5 symptom evaluation score
timeFrame: through study completion, up to 4 weeks
Secondary outcomes:
measure: Head position tracking accuracy
timeFrame: 2 weeks from injury
measure: Head force tracking accuracy
timeFrame: 2 weeks from injury
measure: Return to play duration
timeFrame: through study completion, up to 4 weeks
Other outcomes:
Locations:
city: East Lansing
country: United States
facility: MSU Center for Orthopedic Research
state: Michigan
Study officials:
References:
Clinical trial NCT02865278: Bioavailability of the Polyphenols Contained in a Red Grape Extract-based Drink and Their Metabolic Effects
Official title: Evaluation of the Bioavailability of Polyphenols From a Red Grape Extract-based Drink and the Acute Effects of Its Consumption on Glucose and Lipid Response During the Subsequent Meal
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2016-08-12
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Randomized placebo-controlled crossover study during which participants undergo two different experimental days. The participants consume a red grape based- drink (polyphenols: 300 mg/100 ml and sugar: 9.8g/100 ml) or a placebo (no polyphenols and sugar: 9.8g/100 ml). After 3 hours they consume a test meal (905 kcal, 15% protein, 46% fat, 39% CHO). Blood samples are taken at fasting, over 3 hours after drink consumption and over 5 hours after the test meal to evaluate metabolic response. Fasting and 48h-urine are collected to evaluate bioavailability.


Eligibility criteria: Inclusion Criteria:

* BMI \>25 and \<35 kg/m2
* Total cholesterol \<250 mg/dl
* Triglyceride \< 200 mg/dl.
* Fasting glucose \<100 mg/dl

Exclusion Criteria:

* Cardiovascular events (IMA or stroke) in the 6 months prior to the study
* Kidney or liver failure
* Anemia (Hb \<12 g/dl)
* Any chronic disease
* Intense physical activity
* Dietary supplements

Primary outcomes:
measure: Phenolic metabolites in urine
timeFrame: 48 hours
Secondary outcomes:
measure: Glucose response
timeFrame: 8 hours
measure: Inflammation
timeFrame: 8 hours
measure: Oxidative stress (urinary isoprostanes)
timeFrame: 8 hours
measure: Triglyceride response
timeFrame: 8 hours
Other outcomes:
Locations:
Study officials:
References:
citation: Costabile G, Vitale M, Luongo D, Naviglio D, Vetrani C, Ciciola P, Tura A, Castello F, Mena P, Del Rio D, Capaldo B, Rivellese AA, Riccardi G, Giacco R. Grape pomace polyphenols improve insulin response to a standard meal in healthy individuals: A pilot study. Clin Nutr. 2019 Dec;38(6):2727-2734. doi: 10.1016/j.clnu.2018.11.028. Epub 2018 Dec 7.
Clinical trial NCT02388178: To Determine the Ability of a New Product Formulation to Remineralize an Early Caries Lesion by an In-situ Study
Official title: Assessment of 1450 Ppm Fluoride/Arginine Toothpaste Using an Intra-oral Remineralization-demineralization Model.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Dental Caries
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2015-03-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a double blind, cross-over, controlled clinical trial utilizing thirty (30) adults to evaluate remineralization of early caries lesions.


Eligibility criteria: Inclusion Criteria:

1. Male and/or female subjects 18 to 50 years inclusive
2. Minimum of 20 natural uncrowned teeth (excluding third molars) must be present
3. Willing to wear retainer 24 hours per day
4. No active, unrestored cavities
5. Have normal salivary flow rate (stimulated and unstimulated flow of ≥0.7 ml/min and ≥ 0.2 ml/min respectively) ascertained from a preliminary sialometry
6. Available throughout entire study
7. Willing to use only assigned products for oral hygiene throughout the duration of the study
8. Must give written informed consent
9. Must be in good general health
10. No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study

Exclusion Criteria:

1. Advanced periodontal disease
2. Medical condition which requires premedication prior to dental visits/procedures
3. Not enough teeth to secure the oral retainer
4. Diseases of the soft or hard oral tissues
5. Wear an Orthodontic appliances
6. Impaired salivary function
7. Current use drugs that can affect salivary flow
8. Use antibiotics one (1) month prior to or during this study
9. Pregnant or breastfeeding
10. Participate in another clinical study one (1) week prior to the start of the washout period or during this 9-week study period
11. Use tobacco products
12. Allergic to common toothpaste ingredients
13. Allergic to amino acids
14. Immune compromised individuals (HIV, AIDS, immuno-suppressive drug therapy)

Primary outcomes:
measure: Mineral Change (delta Z)
timeFrame: Baseline
measure: Mineral Change (delta Z)
timeFrame: 2 weeks (from Baseline)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas
name: Bennet Amaechi, PhD, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02901678: The Effect of Different Force Magnitudes on Maxillary Posterior Segment Intrusion
Official title: The Effect of Two Different Force Magnitudes on Maxillary Posterior Segment Intrusion in Adult Patients With Skeletal Open Bite Using Temporary Anchorage Devices- A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontics
Keywords: skelatal open bite, posterior intrusion
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Randomized clinical trial comparing two different force magnitudes in maxillary posterior segment intrusion in adult patients with skeletal open bite malocclusion

Detailed description: This randomized controlled trial is aiming to study the effect of the different force magnitude on maxillary posterior segment intrusion. Two groups are going to be allocated and the amount and rate of intrusion will be measured and compared.

Eligibility criteria: Inclusion Criteria:

* Adult patients with an age range from 17 to 25.
* Skeletal open bite.
* Dental open bite that is due to overgrowth of maxillary posterior segment as seen clinically and that can be corrected without surgical intervention (a minimum of 3 mm and a maximum of 8 mm).
* Skeletal class I or mild to moderate skeletal class II that enables camouflage treatment.
* Normal incisor show on smiling (that makes the case indicated for molar intrusion and not for incisor extrusion).
* Full set of maxillary posterior dentition (first and second premolars, first molars at least).
* No previous orthodontic treatment.

Exclusion Criteria:

* Medically compromised patients.
* Patients suffering from any congenital or hereditary diseases.
* Smoking or any systemic diseases.
* Chronic use of any medications including antibiotics, phenytoin, cyclosporin, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers.

Primary outcomes:
measure: Amount of intrusion
timeFrame: 6 months
measure: Rate of bite closure
timeFrame: 6 months
Secondary outcomes:
measure: Average rate of intrusion
timeFrame: 6 months
measure: Root resorption
timeFrame: 6 months
measure: Tipping
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry
Study officials:
References: