louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04868526: Dietary Intervention to Mitigate Adverse Consequences of Night Work
Official title: Dietary Intervention to Mitigate Adverse Consequences of Night Work
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dietary Habits
Keywords: Night shift work
Glucose tolerance
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-05-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to test whether our dietary intervention can prevent or lessen the negative health effects of night shift work in healthy participants.

Participants will:

* complete 2 inpatient stays
* be provided with identical meals
* have frequent blood draws
* provide urine, saliva, stool and rectal swab samples

Detailed description: Shift work increases the risk for diabetes possibly due to the adverse metabolic effects of circadian misalignment. As shift work is not foreseen to disappear, the development of individually-targeted therapies for metabolic health in these vulnerable shift workers is urgently needed. This research will determine whether our dietary intervention can mitigate the adverse metabolic effects of circadian misalignment, which may help in the design of evidence-based dietary interventions to improve the metabolic health in shift workers.

Eligibility criteria: Inclusion Criteria:

* 18-45 yr old
* BMI 20.0-29.9
* European/Hispanic/African-American ancestry
* No acute, chronic or debilitating medical conditions (e.g. metabolic, cardiovascular, respiratory, neurological, cancers, etc.)

Exclusion Criteria:

* Currently smoking/vaping or 5 or more years of smoking/vaping
* History of drug or alcohol dependency
* History of psychiatric illness or disorder

Primary outcomes:
measure: Change in glucose tolerance from Baseline to Test Day
timeFrame: Baseline (Day 2) and Test Day (Day 4)
measure: Changes in microbial community structure/composition/function of oral and gut microbiome from Baseline to Test Day
timeFrame: Baseline (Day 2) and Test Day (Day 4)
Secondary outcomes:
measure: Change in insulin sensitivity (Oral Minimal Model method) from Baseline to Test Day
timeFrame: Baseline (Day 2) and Test Day (Day 4)
measure: Change in levels of serum markers of gut microbiota from Baseline to Test Day
timeFrame: Baseline (Day 2) and Test Day (Day 4)
measure: Change in levels of serum markers of intestinal barrier integrity from Baseline to Test Day
timeFrame: Baseline (Day 2) and Test Day (Day 4)
measure: Change in level of serum markers of inflammatory state from Baseline to Test Day
timeFrame: Baseline (Day 2) and Test Day (Day 4)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Frank Scheer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06583226: The Effect of Two Different Approaches on Palatal Donor Site
Official title: The Effect of Two Different Approaches on Palatal Donor Site Management After De-epithelialized Graft Harvesting: Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Heal
Keywords: coconut oil
wound healing
palatal graft harvesting
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An epithelialized gingival graft will be harvested from the palate for the treatment of various mucogingival deformities. The donor site will be treated with either a combination of a collagen sponge, cyanoacrylate and suspending sutures or a collagen sponge, cyanoacrylate, suspending sutures and coconut oil.

Detailed description: After epithelialized gingival graft harvesting, intraoperatively, measurements will be taken for palatal tissue thickness, graft dimensions, working time, and primary bleeding time. Data regarding pain perception will be gauged using a visual analog scale, and the number of analgesics, secondary bleeding, epithelization level, and color match will be assessed prospectively. These outcomes will be evaluated on the first 7 days and subsequently on the 14th, 21st, and 28th days. Patient-reported outcomes will be recorded using the Oral Health Impact Profile-14 questionnaire.

Eligibility criteria: Inclusion Criteria:

age ≥18; mucogingival surgical treatment indication that needs connective tissue graft in the anterior mandible; stable periodontium after phase I therapy; full-mouth plaque and bleeding scores \&lt;15%

Exclusion Criteria:

* previous palatal harvesting history; unstable endodontic conditions; tooth mobility at the surgical site; systemic disease; pregnancy; use of medications with potential adverse effects on periodontal tissues

Primary outcomes:
measure: Donor site pain perception
timeFrame: everyday in first week
measure: Secondary bleeding time
timeFrame: during first week
Secondary outcomes:
measure: Graft height
timeFrame: during surgery
measure: Graft width
timeFrame: during surgery
measure: Graft thickness
timeFrame: during surgery
measure: Working time
timeFrame: during surgery
measure: Quantity of analgesics
timeFrame: first week
measure: Sensation loss
timeFrame: first week, second week , third week, fourth week.
measure: Color match
timeFrame: first week, second week, third week, fourth week.
measure: Epithelization level
timeFrame: first week, second week, third week, fourth week.
measure: The Oral Health Impact Profile-14 is a questionnaire that measures how oral disorders impact a patient&#39;s quality of life.
timeFrame: first week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
state: Fatih
Study officials:
References:
Clinical trial NCT03534726: Edema and Fibrosis CMR Imaging in Cardiomyopathy
Official title: Edema and Fibrosis Cardiac Magnetic Resonance Imaging in Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cardiomyopathies
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2018-05-23
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The eligible population are cardiomyopathy patients and normal volunteers.

Brief summary: 7 Tesla MRI is a new magnetic field strength that has become available at Penn for cardiovascular MRI. This new scanner has potential to improve assessment of cardiovascular disease due to its increased signal-to-noise ratio, higher spatial resolution, and response to magnetic properties of tissue at high field. The purpose of this study is to assess the feasibility of 7 T CMR. Secondly, we wish to investigate its use, to improve clinical and research MRI. Altogether, 7 T may permit better clinical diagnosis of cardiomyopathy.


Eligibility criteria: Inclusion Criteria:

* Subjects between the ages of 20-70 years old

Exclusion Criteria:

* Advanced renal disease (estimated GFR rate \< 30 mL/min) or hypersensitivity to gadolinium contrast agent.
* Presence of cardiac pacemaker or implanted cardioverter defibrillator
* Pregnancy
* Inability to provide informed consent
* Other contraindications to MRI (such as claustrophobia)

Primary outcomes:
measure: ejection fraction
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01387126: Effects of a High Viscosity Dietary Fibre, as Part of a Medically Supervised Weight Management Program
Official title: A Randomized, Controlled Trial Evaluating the Effects of a High Viscosity Dietary Fibre, as Part of a Medically Supervised Weight Management Program, on Body Weight in Overweight and Obese Individuals
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Obesity
Lead sponsor: Canadian Center for Functional Medicine
Sponsor class: OTHER
Collaborators: name: University of British Columbia
name: InovoBiologic Inc.
First posted: 2011-07-04
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate whether the supplementation of a medically supervised weight management program with a novel fibre supplement, improves body weight, body composition, and laboratory measurements in overweight and obese individuals. All subjects will participate in the medical weight management program however the intervention group will have 5 grams of a novel fibre supplemented to each meal while the control group will not.


Eligibility criteria: Inclusion Criteria:

* BMI 27 - 30 Kg/m2 with 1 weight-related comorbidity and/or BMI 30 - 50 Kg/m2
* Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation in English

Exclusion Criteria:

* Medications and supplements that affect body weight and appetite
* Type 2 diabetes on insulin treatment
* Contraindications to low calorie diet
* Any allergies to study product ingredients
* Any other medical, social or geographic condition, which, in the opinion of the investigator would not allow safe completion of the protocol.

Primary outcomes:
measure: Body weight
timeFrame: 52 weeks
Secondary outcomes:
measure: Body composition
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Coquitlam
country: Canada
facility: Canadian Centre for Functional Medicine
state: British Columbia
Study officials:
affiliation: Canadian Centre for Functional Medicine
name: Michael R Lyon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00656526: Preemptive Analgesia for Postlaminectomy
Official title: Intraoperative Perineural Injection of Lidocaine for Postlaminectomy Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Laminectomy
Keywords: analgesia, postlaminectomy , lidocaine, dorsal root
Lead sponsor: Harran University
Sponsor class: OTHER
First posted: 2008-04-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To relieve post laminectomy pain, we have tried intraoperative perineural injection of lidocaine right after the exposure in expecting that this would be preemptive analgesia by blocking the nerve transmission so that postoperative pain starts later and lighter.

Detailed description: A randomized double-blind 40 patients aged 18-50 of ASA I and II undergoing laminectomy were included in the study. All the patients were followed for their heart rate, arterial pressure , respiratory rate, oxygen saturation, end tidal CO2 and postoperative VAS scores.

All the patients were premedicated with midazolam 0.1 mg/kg intramuscularly 40 minutes prior to surgery. The induction was made 2 mg/kg propofol, 1 ug/kg remifentanyl, 0.5mg/kg rocuronium. After the orotracheal intubation anesthesia was maintained with isoflurane (%0.5-2.0) and 0.1 mg/kg rocuronium.Just before the exposure of dorsal root, 0.5 cc %2 lidocaine was injected on the dorsal root.The patients postoperative analgesic period, VAS scores and additional analgesic need was recorded. For the postoperative analgesia tramadol 1 mg/kg tramadol was used.

Eligibility criteria: Inclusion Criteria:

* laminectomy
* 18-50 age
* ASA 1-2
* both sex

Exclusion Criteria:

* under 18 or older than 50
* any disease other than back pain\\
* ASA 3-4

Primary outcomes:
measure: In the laminectomy operation, right after the exposure of the dorsal root , an injection of lidocaine attenuates postoperative pain.
timeFrame: postoperative 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Sanliurfa
country: Turkey
facility: harran University Education, Research and application hospital
Study officials:
affiliation: Harran University
name: cengiz Mordeniz, MD, Ass Prof
role: STUDY_CHAIR
References:
Clinical trial NCT03408626: Microbiological Assessment After Chemo-Mechanical Caries Removal Using Papain-based Enzyme Versus Conventional Rotary Tools in Occlusal Carious Lesions
Official title: Microbiological Assessment After Chemo-Mechanical Caries Removal Using Papain-based Enzyme Versus Conventional Rotary Tools in Occlusal Carious Lesions: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Microbial Colonization
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-01-24
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted to assess the efficacy of caries excavation using the papain-based chemo-mechanical method (Brix 3000) in comparison to conventional rotary tools in the reduction of the bacterial population in occlusal carious cavities

Detailed description: Twenty-three patients who will fulfill the inclusion criteria will be enrolled to the study. For every patient two contra-lateral class I carious molars will be selected, so the total number of included molars will be 46 molars. One contra-lateral molar will be randomly assigned to the chemo-mechanical (Brix 3000) caries removal technique and the other will be assigned to the conventional rotary one. From every molar two dentin specimens will be collected (baseline and after excavation) with a total of 92 samples

Eligibility criteria: Inclusion Criteria:

1. Class I carious lesions
2. Lower molars
3. Bilateral lesions
4. 18 -50 years
5. Males or Females (Both genders)
6. Good oral hygiene
7. Co-operative patients approving the trial

Exclusion Criteria:

1. Pregnancy
2. Systemic disease or severe medical complications
3. Periodontal problem
4. Mobile teeth, arrest caries and non-vital teeth
5. Smokers
6. Xerostomia
7. Lack of compliance
8. Not received antibiotic therapy since 1 month before sampling

Primary outcomes:
measure: bacterial count by Digital Colony Counter
timeFrame: at the same visit (20 minutes)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02182726: Postmarketing Surveillance Study With MOBEC®
Official title: COX-2 Postmarketing Surveillance Study With MOBEC® 15 mg Tablets
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-08
Enrollment: 4760
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primarily internal and general medical practices

Brief summary: The aim of the study is to investigate

* the indication for MOBEC in a dose of 15 mg per day
* the treatments patients were receiving before switching to 15 mg MOBEC
* how treatment with 15 mg is assessed compared with previous treatment
* how effective and safe treatment with 15 mg MOBEC is considered


Eligibility criteria: Inclusion Criteria:

* An indication for a treatment with 15 mg MOBEC of at least four weeks

  * the symptomatic short-term treatment of osteoarthritis
  * the symptomatic long-term treatment of rheumatoid arthritis (chronic polyarthritis); restriction: the recommended dose for long-term treatment of elderly patients is 7.5 mg)
  * the symptomatic treatment of ankylosing spondylitis

Exclusion Criteria:

* Treatment with MOBEC prior to the start of the study
* Patients with any of the general or specific contraindications of MOBEC

Primary outcomes:
measure: Nature and incidence of adverse drug reactions (ADR)
timeFrame: up to week 8
measure: Assessment of efficacy by physician on a 5-point scale
timeFrame: up to week 8
measure: Assessment of tolerability by physician on a 5-point scale
timeFrame: up to week 8
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00154726: Paclitaxel-HDFL for Locally Advanced and Recurrent/Metastatic Gastric Cancers
Official title: A Phase II Study of Weekly Paclitaxel(Taxol)and 24-Hour Infusion High-Dose 5-Fluorouracil and Leucovorin(HDFL)in the Treatment Locally Advanced and Recurrent/Metastatic Gastric Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Locally Advanced and Recurrent/Metastatic Gastric Cancer
Keywords: Paclitaxel-HDFL,Locally Advanced and Recurrent/Metastatic Gastric Cancer
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy,response rate,time to treatment failure,overall survival,toxicities of Paclitaxel-HDFL regimen in locally advanced/inoperable and recurrent/metastatic gastric cancers. To evaluate the resectability and relapse pattern after potentially curative resection of neoadjuvant Paclitaxel-HDFL regimen

Detailed description: In the treatment of metastatic breast cancer, paclitaxel followed by weekly HDFL has been shown to have a 55% response rate in anthracycline-resistant patient. Recently, regimen combining paclitaxel and moderately-high-dose 5-FU (1500mg/m2) has had response rate up to 61.5% (including 23%CR) in a small group of gastric cancer patients (8 responders in 13 patients). Thus, the sequential use of weekly paclitaxel followed by weekly HDFL regimen may become a new generation of chemotherapeutic regimen for the treatment of gastric cancer. Further study with a larger group of patients and further testing of possible schedules of administration are warranted.

Eligibility criteria: Inclusion Criteria: 1.Histologically or cytologically confirmed gastric adenocarcinoma 2.Measurable or evaluable disease 3.No previous C/T 4.Age 18 \~ 70 years 5.KPS \>=60% 6.WBC\>=4,000, pltate\>=100K, Creatinine\<=1.5mg/dl, serum bil\<=1x UNL, transaminase\<=3.5x ULN

Exclusion Criteria: 1.CNS metastasis 2.Patients receive concomitant anti-cancer C/T or R/T 3.Patients who are pregnant and with an expected life expectancy less than 3months 4.Symptomatic heart disease,active infection, extensive liver disease or liver cirrhosis 5.TG\<=70mg/dl 6.Mental status is not fit for clinical trial

-

Primary outcomes:
measure: Response rate
Secondary outcomes:
measure: overall survival
Other outcomes:
Locations:
Study officials:
affiliation: Department of Oncology, National Taiwan University Hospital
name: Ann-Lii Cheng, M.D.,Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT03883126: Remote Alcohol Monitoring to Facilitate Abstinence From Alcohol: Exp 1
Official title: Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement With an Underserved Population
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2019-03-20
Enrollment: 200
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: Directly reinforcing abstinence from alcohol with monetary incentives is an effective treatment for alcohol dependence, but barriers in obtaining frequent, verified biochemical measures of abstinence limit the dissemination of this treatment approach. The goal of this study is to use technological advancements to remotely, accurately, and securely monitor alcohol use with a newly developed smartphone app and breathalyzer. This treatment approach has the potential to facilitate the dissemination of an effective, evidence-based treatment for alcohol dependence to a broader population whose treatment needs are not currently being adequately met.


Eligibility criteria: Inclusion Criteria:

* Meet Diagnostic and Statistical Manual (DSM)-5 criteria for alcohol use disorder
* Average 3 or more heavy drinking days (≥5 drinks in one occasion for men, ≥4 for women) per week for the past month on the Timeline Follow-back.
* Must endorse alcohol as their primary drug of use.
* Express a desire to abstain from drinking.

Exclusion Criteria:

* Are currently enrolled in an alcohol treatment program (not including attendance at Alcoholics Anonymous or similar community support meetings).
* Score 23 or greater on the Alcohol Withdrawal Symptom Checklist, a score indicating that medication would be likely required to manage alcohol detoxification.
* Pregnant women, lactating women, or women who are planning to become pregnant in the next 15 months.

Primary outcomes:
measure: Pattern of abstinence from alcohol during intervention
timeFrame: up to 66 weeks
measure: Treatment acceptability
timeFrame: A total of 12 assessment sessions spanning over a 66 week period.
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Nationwide Online Enrollment from the Unversity of Kentucky
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky Turfland: In-person enrollment
state: Kentucky
city: Roanoke
country: United States
facility: Carilion Clinic: In person-enrollment
state: Virginia
Study officials:
References:
Clinical trial NCT00269126: Clinical Evaluation Of GW815SF For Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema)
Official title: See Detailed Description
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD
Chronic Bronchitis
Emphysema
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-12-23
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study compares the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease). This study will last up to 18 weeks, and subjects will visit the clinic 5 times. Subjects will be given breathing tests, and will record their breathing symptoms daily on diary cards.

Detailed description: Clinical Evaluation of GW815SF for Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema) "Assessment of the Effect of Addition of Fluticasone Dipropionate to Salmeterol Xinafoate 50µg after Switching under Double-blinded conditions to GW815SF 50/250µg in Chronic Obstructive Pulmonary Disease

Eligibility criteria: Inclusion criteria:

* Diagnosis of COPD.

Exclusion criteria:

* Diagnosis of asthma or an uncontrolled medical condition or respiratory disorder other than COPD.
* Other inclusion and exclusion criteria will be evaluated at the first study visit.

Primary outcomes:
measure: Change from baseline in pre-dose FEV1 at 4 weeks after starting medication of GW815SF 50/250µg
Secondary outcomes:
measure: Change in morning PEF
measure: Changes in pre-dose FVC, V50, V25
measure: Use of rescue medication
measure: Changes in symptom scores
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: GSK Investigational Site
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: