louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03040440: Comparison of the Cuff Pressure of TaperGuard and Cylindrical- Endotracheal Tube During Laparoscopic Surgery
Official title: Comparison of the Cuff Pressure of TaperGuard Endotracheal Tube and Cylindrical- Endotracheal Tube During Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cuff Pressure
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2017-02-02
Enrollment: 64
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study was to compare the cuff pressure between cylindrical and TaperGuard endotracheal tube during laparoscopic cholecystectomy.

Detailed description: Sixty four participants were assigned to one of the two groups: cylindrical and TaperGuard endotracheal tube. At the supine position, cuff pressure of endotracheal tube was measured before and after abdominal insufflation in the supine position. After insufflation the head-up position (30°) was made and cuff pressure was recorded.

Eligibility criteria: Inclusion Criteria:

* Participants who were underwent laparoscopic cholecystectomy with American Society of Anesthesiologists physical status 1-3

Exclusion Criteria:

* history with respiratory disease, difficult intubation, and morbid obesity (body mass index more than 35 kg/m2).

Primary outcomes:
measure: cuff pressure
timeFrame: 5 minutes after intubation
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
Study officials:
affiliation: Kyungpook National University Hospital
name: Younghoon Jeon, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00235040: Evaluating the Effectiveness of the Acute Respiratory Infection Smart Form
Official title: Evaluating Smart Forms and Quality Dashboards in an EHR: Effectiveness of the Acute Respiratory Infection Smart Form
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Tract Infections
Keywords: Upper Respiratory Infections
Respiratory Tract Infections
Tree Number C01.539.739
Tree Number C08.730
Unique ID D012141
Lead sponsor: Agency for Healthcare Research and Quality (AHRQ)
Sponsor class: FED
First posted: 2005-10-10
Enrollment: 18257
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: To evaluate the effectiveness of the Acute Respiratory Infection Smart Form

Detailed description: Specific Aim 1: To design and implement an integrated documentation-based clinical decision support and physician feedback system, provided in an electronic health record (EHR), to improve the management of patients with acute medical conditions.

Hypothesis 1: A documentation-based clinical decision support tool (CDSS) "smart form" physician feedback system, can be designed and implemented to facilitate documentation and physician order-entry, provide individualized, evidence-based recommendations for the management of patients acute respiratory infections (ARIs), and are usable by primary care physicians.

Specific Aim 2: To determine the effectiveness of documentation-based CDSS and physician feedback on documentation and the clinical management of patients respiratory tract infections.

Hypothesis 2A: A documentation-based CDSS "smart form" will increase the documentation of important clinical data in patients with ARI when compared to usual practice.

Hypothesis 2B: A documentation-based CDSS "smart form" will increase adherence with guidelines for the management of patients with ARI when compared to usual practice.

Eligibility criteria: Inclusion Criteria:

Acute Respiratory Infection visit

Exclusion Criteria:

Any patients who are not part of a panel of a participating physician

Primary outcomes:
measure: Antibiotic prescribing rates
timeFrame: 9 months
Secondary outcomes:
measure: Appropriateness of antibiotic prescribing, re-visit rates, antibiotic costs, use of antibiotics, all-cause antibiotic use, quality of documentation
timeFrame: 9 months
Other outcomes:
Locations:
Study officials:
affiliation: Partners Healthcare Systems Inc
name: Blackford Middleton, MD, MPH, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Linder JA, Schnipper JL, Middleton B. Method of electronic health record documentation and quality of primary care. J Am Med Inform Assoc. 2012 Nov-Dec;19(6):1019-24. doi: 10.1136/amiajnl-2011-000788. Epub 2012 May 19.
Clinical trial NCT03772340: Motion Sifnos: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness
Official title: Motion Sifnos: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness During Travel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Motion Sickness
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2018-12-11
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized, double-blind, placebo-controlled investigating the efficacy of tradipitant in the treatment of motion sickness.


Eligibility criteria: Inclusion Criteria:

* Male or non-pregnant, non-lactating female patients aged 18 - 75 years (inclusive);
* Body Mass Index (BMI) of ≥18 and \<40 kg/m2;
* History or symptoms consistent with motion sickness

Exclusion Criteria:

* Chronic nausea due to condition other than motion sickness;
* A positive test for drugs of abuse at the screening or evaluation visits;
* Clinically significant deviation from normal clinical laboratory results

Primary outcomes:
measure: The Most Severe Motion Sickness Severity During Vehicle Travel
timeFrame: 1 day
measure: Percentage of Vomiting
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Vanda Investigational Site
state: California
Study officials:
References:
Clinical trial NCT00249340: Brief Behavioral Weight Loss Treatment vs. Weight Watchers
Official title: Comparison of a Brief Behavioral Weight Loss Intervention With the Weight Watchers Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Keywords: behavioral weight loss treatment
brief behavioral treatment
commercial weight loss programs
Weight Watchers
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2005-11-07
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effectiveness of Weight Watchers, brief behavioral treatment, and a combination treatment. We hypothesize that a combination treatment will achieve greater weight losses than Weight Watchers alone.

Detailed description: Weight Watchers is a popular nonmedical commercial weight loss program. Recent studies suggest that people enrolled in Weight Watchers lose approximately 3-5 kg in 6 months of treatment. These outcomes are substantially lower than average weight losses achieved in 6 months if university/hospital-based standard behavioral treatment (approximately 10 kg). However, standard behavioral weight loss programs are expensive and have limited accessibility to most people seeking weight loss. Therefore, the purpose of the current study is to investigate whether enhancing Weight Watchers by adding an 8-week group-based behavioral weight loss program prior to participation in Weight Watchers will improve weight loss outcomes at 6 months.

Comparison: 6 months of Weight Watchers vs. combination treatment (2 months of standard behavioral weight loss treatment followed by 4 months of Weight Watchers) vs. 2 months of standard behavioral treatment.

Eligibility criteria: Inclusion Criteria:

Age 21-65 years BMI 27-45 kg/m2 Able to sign informed consent

Exclusion Criteria:

Women who are pregnant, nursing, less than 6 months postpartum, or plan to become pregnant during course of study Individuals who report a medical condition that would affect the safety and/or efficacy of a weight management program involving dietary change and physical activity (e.g., heart disease, cancer) Individuals with major psychiatric illness that would interfere with protocol adherence Individuals who are currently participating in a weight loss program or taking weight loss medication or lost \>=5% of body weight during 6 months prior to screening Recent (within the past 12 months) participation in Weight Watchers

Primary outcomes:
measure: Weight Loss
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Weight Control and Diabetes Research Center/The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Rena R Wing, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Miriam Hospital
name: Angela M Pinto, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06060340: Clinical and Radiographic Outcomes of Class II Furcation Defects Management Using Propolis: A Case Series
Official title: Clinical and Radiographic Outcomes of Class II Furcation Defects Management Using Propolis: A Case Series
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Furcation Defects
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Furcation involvement represents a challenge for treatment to many periodontists due to many factors including access, morphology, and variations of anatomical features of the furcation area. Furcation involvement treatment includes non-surgical periodontal therapy, resective surgery and regenerative surgery, regenerative therapy utilizing different graft materials and membranes is of high cost and research for new materials that can be cost-effective and available for all patients is continuing, propolis have been shown to be cost-effective therapy for bone and wound healing.

Detailed description: Propolis is a natural resinous product of the bee workers collected from trees to use it to stick their hives and form a coat to protect their hives from all sources of bacteria and invasions. Propolis is composed of more than 300 compounds, the most important of them are flavonoids like CAPE (caffeic acid phenyl ester). Propolis have shown anti-inflammatory, anti-oxidant, anti-bacterial, anti-fungal, anti-viral and more importantly regenerative effect and bone formation capabilities.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria:

  1. Lower molars with class II furcation defects.
  2. Full mouth plaque score (FMPS )\<20% at baseline.
  3. Full mouth bleeding score (FMBS )\<10% at baseline.
  4. Systemically healthy.
  5. Cooperative patients.

Exclusion Criteria:

* Exclusion criteria:

  1. Smokers.
  2. Pregnancy and lactation.
  3. Stage 4 Grade C periodontitis.

Primary outcomes:
measure: Horizontal and Vertical Clinical Attachment Level (CAL)
timeFrame: 6 months
Secondary outcomes:
measure: Radiographic Defect Fill
timeFrame: 6 months
measure: Probing Depth (PD)
timeFrame: 6 months
measure: Bleeding on Probing (BOP)
timeFrame: 6 months
measure: Plaque Index (PI)
timeFrame: 6 months
measure: Gingival Recession
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
state: El-Manial
Study officials:
References:
Clinical trial NCT04261140: Clinical Evaluation of Four Aesthetic Restorations in Non-carious Cervical Lesions
Official title: Clinical Evaluation of Four Aesthetic Restorations in Non-carious Cervical Lesions: a Randomised Controlled Split-mouth Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Noncarious Cervical Lesions
Keywords: High-viscosity glass ionomer
bulkfill composite
flowable composite
nanohybrid composite
cervical lesion
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-02-07
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the clinical performance of high-viscosity glass ionomer, flowable composite, bulkfill composite and nanohybrid composite restorations in non-carious cervical lesions (NCCLs).

Detailed description: One hundred fourty NCCLs were randomised into four groups according to a split-mouth design. Clinical evaluations will be performed after 1 week, 3 months, 6 months, using FDI (World Dental Federation) criteria.

Eligibility criteria: Inclusion Criteria:

* had at least four non-carious symmetrical cervical lesions,
* had permanent dentition and were older than 20 years old,
* had cervical margins in dentin

Exclusion Criteria:

* periodontal disease
* pregnant or breastfeeding
* being under orthodontic therapy

Primary outcomes:
measure: evaluation of restoration on cervical lesions
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rize
country: Turkey
facility: Recep Tayyip Erdogan University Dentistry Faculty
Study officials:
affiliation: Recep Tayyip Erdogan University Dentistry Faculty
name: Gül Yıldız Telatar, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05792540: Clinical Study to Evaluate the Possible Efficacy of Dapagliflozin and Atorvastatin in Patients With Major Depressive Disorders
Official title: Clinical Study to Evaluate the Possible Efficacy of Dapagliflozin and Atorvastatin in Patients With Major Depressive Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depressive Disorder
Lead sponsor: Tanta University
Sponsor class: OTHER
Collaborators: name: Manal Ali Mahrous Hamouda Faculty of Pharmacy, Menufia University
First posted: 2023-03-31
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Major depressive disorder (MDD) is a significant cause of disability that affects approximately 16% of the world's population and is associated with chronic inflammation. Although the mechanisms of MDD have not yet been clearly elucidated, NLRP3 inflammasomes have been implicated in the pathogenesis of depression.NLRP3 inflammasome is an intracellular multiprotein complex that consists of nod-like receptor protein 3, an adaptor protein, and a procaspase-1 precursor. It is well known that a variety of danger signals, such as pathogen-associated molecular patterns and danger-associated molecular patterns can activate NLRP3 inflammasome


Eligibility criteria: Inclusion Criteria:

- Age ≥ 18 years Both males and females will be included Negative pregnancy test and effective contraception. Depressed patients for at least 2 months with a Hamilton rating score of more than 18.

Exclusion Criteria:

* Patients with bipolar I or bipolar II disorder
* Patients with personality disorders
* Patients with eating disorders
* Patients with substance dependence or abuse
* Patients with concurrent active medical conditions
* Patients with a history of seizures
* Patients with a history of receiving Electroconvulsive therapy (ECT)
* Patients with inflammatory disorders
* Patients with allergies or contraindications to the used medications
* Patients with finally pregnant or lactating females
* Diabetic or hyperlipidaemic patients

Primary outcomes:
measure: • The primary endpoint is the change in Hamilton Rating Scale
timeFrame: 3 months
Secondary outcomes:
measure: The secondary endpoint is estimated by changes in serum biomarkers.
timeFrame: 3 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Medicine, Menoufia University
state: Shebeen El-Kom
Study officials:
References:
Clinical trial NCT04915040: Management of Depression and Social Isolation in Older Adults With Dementia With Home-based Telehealth Delivered Behavioral Activation + Caregiver Facilitation.
Official title: Management of Depression and Social Isolation in Older Adults With Dementia With Home-based Telehealth Delivered Behavioral Activation + Caregiver Facilitation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: social support
dementia
caregivers
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 7
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the feasibility of using behavioral activation therapy with caregiver support delivered via telemedicine to older adults with depression and probable mild dementia.


Eligibility criteria: Inclusion Criteria:

Participant Eligibility Criteria:

* able to speak and understand English;
* a diagnosis of mild dementia, as determined by a Clinical Dementia Rating interview Sum of Boxes (CDR-SB) score in the mild range as defined by a score of 4.5 - 9.0;
* and able to provide informed consent.

Caregiver Eligibility Criteria.

* Beck Depression Inventory (BDI) score below clinical cutoff for depression and able to provide informed consent.

Exclusion Criteria:

Participant exclusion criteria:

* presence of suicidal ideation with clear intent,
* concurrent enrollment in another clinical trial for depression,
* substance use disorder.

Caregiver exclusion criteria:

* Active psychosis or significant dementia at screening;
* presence of suicidal ideation with clear intent.

Primary outcomes:
measure: Feasibility of recruitment as assessed by number of participants enrolled in the study
timeFrame: Week 0
measure: Feasibility of retention as assessed by number of participants who complete at least 6 sessions
timeFrame: Week 8
measure: Feasibility of data collection as assessed by percent of missing data
timeFrame: Week 8
measure: Change in Depression as measured by the Geriatric Depression Scale
timeFrame: Week 0, Week 4, Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
Study officials:
References:
Clinical trial NCT00836940: A Clinical Study of GRC 8200 in Type 2 Diabetes Mellitus
Official title: A 12-week Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate Safety, Tolerability, and Efficacy of GRC 8200, a New Oral DPP -IV Inhibitor, in Patients With Type 2 Diabetes Mellitus.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus
GRC 8200
Lead sponsor: Glenmark Pharmaceuticals Europe Ltd. (R&D)
Sponsor class: INDUSTRY
First posted: 2009-02-04
Enrollment: 480
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is aimed at evaluating efficacy and safety of GRC 8200 in type 2 diabetes mellitus patients.

The study involves six weeks of wash out period and two weeks run in period for patients currently on mono-therapy and a two week run in period only for drug naïve patients.

This is a placebo controlled study. One of the five treatment arms is placebo. The duration of treatment is 12 weeks.


Eligibility criteria: Inclusion Criteria:

* Male or female patients ≥30 years of age
* At screening, females of non-childbearing potential or females of childbearing potential with adequate contraception
* Has an established clinical diagnosis of type 2 diabetes mellitus for at least 3 months prior to the screening period
* Is being treated for diabetes either with diet and exercise alone, or on monotherapy with any of the antidiabetic drugs
* Has an HbA1c value at screening between 6.5% and 10%

Exclusion Criteria:

* Has type 1 diabetes
* Is a female who is lactating or is pregnant
* Has a history of acute metabolic diabetic complications
* Has clinically significant disease other than type 2 diabetes mellitus

Primary outcomes:
measure: Change from baseline in HbA1c compared with placebo at the end of 12 week treatment period
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in HbA1c from baseline at the end of 4 and 8 weeks of treatment
timeFrame: 4 and 8 weeks
measure: Fasting plasma glucose and fasting serum insulin
timeFrame: 12 weeks
measure: Plasma glucose 2 hours post glucose challenge (OGTT)
timeFrame: 12 weeks
measure: HOMA-IR
timeFrame: 12 weeks
measure: HOMA-B
timeFrame: 12 weeks
measure: Change in serum lipids
timeFrame: 12 weeks
measure: Body weight
timeFrame: 12 weeks
measure: Waist circumference
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Glenmark Investigational site
Study officials:
References: