louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01845363: Antibiotic Prophylaxis in Bariatric Surgery With Cefazolin: Concentration in Adipose Tissue
Official title: Antibiotic Prophylaxis in Bariatric Surgery With Continuous Infusion of Cefazolin: Determination of Concentration in Adipose Tissue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Keywords: Obesity
Bariatric surgery
Cefazolin
antimicrobial prophylaxis
administration and dosage
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2013-05-03
Enrollment: 18
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: Eighteen patients were given a dose of 2g Cefazolin in anesthetic induction, supplemented with 1g delivered through continuous infusion during surgery. Adipose samples, obtained at the beginning and end of surgery, were analyzed using high performance liquid chromatography.

Some published studies suggest that the dose of 2g does not supply the minimum inhibitory concentration for principal causal agents of surgical site infection.

To determine the concentration of Cefazolin in adipose tissue of patients undergoing bariatric surgery and to evaluate the relationship between concentrations obtained and body mass index (BMI).


Eligibility criteria: Inclusion Criteria:

* body mass index greater than 35 and less than 50kg/m2

Exclusion Criteria:

* Hypotension during surgery with use of vasoactive drugs
* renal disfunction (creatinine \>1.5 mg/dL)

Primary outcomes:
measure: dosage of Cefazolin in adipose tissue during bariatric surgery
timeFrame: eight months
Secondary outcomes:
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Universidade Federal de Pernambuco - Hospital das Clínicas
state: Pernambuco
Study officials:
affiliation: UFPE
name: Rafael Anlicoara, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UFPE - Hospital das Clínicas
name: Alvaro AB Ferraz, PhD
role: STUDY_CHAIR
affiliation: Laboratory of Immunopathology Keiso Asami(LIKA) - UFPE
name: José L de Lima Filho, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06141863: Temporomandibular Dysfunction in Patients With Cervical Disc Herniation
Official title: Investigation of Temporomandibular Dysfunction in Patients With Cervical Disc Herniation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Temporomandibular Joint Dysfunction Syndrome
Keywords: Temporomandibular Joint Dysfunction Syndrome
Intervertebral Disc Displacement
Disability
Neck
Jaw
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2023-11-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals diagnosed with cervical disc herniation. Patients who were referred to physiotherapy after diagnosis were evaluated in terms of study suitability before starting treatment. We divided the participants into two groups based on their level of neck disability to compare their TMD.

Brief summary: Cervical spine problems are associated with temporomandibular joint (TMJ) and related muscles.The aim of the present study was to investigate temporomandibular joint dysfunction (TMD) and pain in individuals with cervical disc herniation (CDH) according to the level of neck disability.

Detailed description: The study included diagnosed with cervical disc herniation. The participants were divided into two groups based on their The Neck Disability Index (NDI) score: Group 1 with no disability and mild disability and Group 2 with moderate and severe disability. Temporomandibular dysfunction and its severity, intensity of neck and temporomandibular joint pain was assessed.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with cervical disc herniation aged between 18 and 65,
* who could read and write in Turkish

Exclusion Criteria:

* Individuals with a history of head and neck surgery, fracture, physiotherapy or medical treatment cervical or temporomandibular joint treatment within the last six months,
* presence of any inflammatory rheumatic diseases, such as ankylosing spondylitis and rheumatoid arthritis, facial paralysis, infection, advanced osteoporosis

Primary outcomes:
measure: Neck Disability Index
timeFrame: one day assessment
measure: Fonseca Anamnestic Index
timeFrame: one day assessment
Secondary outcomes:
measure: Visual Analogue Scale
timeFrame: one day assessment
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Technical University
Study officials:
affiliation: Karadeniz Technical University
name: Turgay Altunalan, Assist Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01101763: A Study of the Kinetics of a 13C-Cholesterol Infusate in Healthy Male Subjects (0000-108)(COMPLETED)
Official title: A Pilot Study to Evaluate the Plasma Enrichment Kinetics of a 13C-Cholesterol Infusate in Healthy Male Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyslipidemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-04-12
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited for the study

Brief summary: This is a 2-part pilot study in healthy male subjects to evaluate plasma enrichment kinetics of \[13C3,4\]-cholesterol (Part I) and to assess the test-retest reproducibility (Part II) of Reverse Cholesterol Transport (RCT) measurements. The study will determine whether atom percent enrichment (% APE) at 18 hours can be extrapolated from the steady-state value and whether the mean difference in repeat Ra measurements is below is a prespecified level.


Eligibility criteria: Inclusion Criteria:

* Subject is male 18 to 45 years of age at screening
* Subject has a stable weight (± 2 kg) for more then 6 weeks prior to screening

Exclusion Criteria:

* Subject has a history of ileal bypass, gastric bypass, or other significant condition associated with malabsorption
* Subject has an active or recent (\<2 weeks) gastrointestinal condition (gastroenteritis, diarrhea, chronic constipation, irritable bowl syndrome, etc.) affecting bowel movements
* Subject has a known allergy to beans, peas, eggs or egg-derived products and/or soy or soy-derived products
* Subject has a history of plant sterol storage disease (sitosterolemia, cerebrotendinotic xanthomatosis) or a history of intolerance to plant sterols and/or plant sterol containing products
* Subject has a history of hepatic or gall bladder disease (including gallstones, cholecystectomy, etc.)
* Subject is currently taking psyllium, other fiber-based laxatives, phytosterol margarines, and/or over the counter (OTC) therapies that are known to affect serum lipids
* Subject has taken lipid-lowering agents within 6 weeks prior to screening
* Subject has previously been administered an intravenous infusion of \[13C3,4\]-cholesterol

Primary outcomes:
measure: %APE (atom percent enrichment) for all study subjects in Part I at 18 hours
timeFrame: 18 hours
measure: Rate of appearance (Ra) of unlabeled cholesterol from the whole-body peripheral pool
timeFrame: Baseline and 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00187863: Biopsychosocial Factors' Influence on Shoulder Pain
Official title: Biopsychosocial Factors' Influence on Shoulder Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic shoulder pain and disability

Brief summary: The purpose of this study is to determine which factors are associated with the development of chronic shoulder pain and disability.

Detailed description: The purpose of this study is to determine which factors are associated with the development of chronic shoulder pain and disability. Previous studies have suggested that specific genes influence pain perception. Other studies have suggested that specific psychological factors influence pain perception. We plan to investigate both of these factors to see if they contribute to the development of chronic shoulder pain and disability.

Eligibility criteria: Inclusion Criteria:

* chronic shoulder pain and disability

Exclusion Criteria:

* none

Primary outcomes:
measure: Disability
timeFrame: Baseline to 12 months
measure: Pain intensity
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Physical impairment
timeFrame: Baseline to 12 months
measure: Activity evoked pain
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Orthopaedics and Sports Medicine Institute
state: Florida
Study officials:
affiliation: University of Florida
name: Steven Z. George, PT, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: George SZ, Wu SS, Wallace MR, Moser MW, Wright TW, Farmer KW, Greenfield WH 3rd, Dai Y, Li H, Fillingim RB. Biopsychosocial Influence on Shoulder Pain: Influence of Genetic and Psychological Combinations on Twelve-Month Postoperative Pain and Disability Outcomes. Arthritis Care Res (Hoboken). 2016 Nov;68(11):1671-1680. doi: 10.1002/acr.22876. Epub 2016 Oct 6.
Clinical trial NCT03045263: Pivotal Response Treatment (PRT) Telemedicine
Official title: Pivotal Response Treatment Telemedicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: ASD
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2017-02-07
Enrollment: 7
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the application of a modified version of PRT designed specifically as a parent-training model via telemedicine, with the goal of increasing access to empirically validated care. The project will feature an 18-week trial of parent training PRT via telemedicine in 12 cognitively able 3- to 6-year-old children with ASD. Intervention will focus on enhancing the following developmental skills: expressive and receptive language, play, and social interaction. Outcome measures will address changes in the aforementioned domains during structured observation and standardized assessment.

Detailed description: The purpose of this study is to evaluate the application of a modified version of PRT designed specifically as a parent-training model via telemedicine, with the goal of increasing access to empirically validated care. The project will feature an 18-week trial of parent training PRT via telemedicine in 12 cognitively able 3- to 6-year-old children with ASD. Intervention will focus on enhancing the following developmental skills: expressive and receptive language, play, and social interaction. Outcome measures will address changes in the aforementioned domains during structured observation and standardized assessment.

Eligibility criteria: Inclusion Criteria:

* Fits age requirement: age 3-6 years
* Have been diagnosed previously with ASD and meet criteria for ASD when characterized by research team.
* be in good medical health
* be cooperative with testing
* english is a language spoken in the family
* full scale IQ \> 70

Exclusion Criteria:

* significant hearing loss or other severe sensory impairment
* a fragile health status
* a history of significant head trauma or serious brain or psychiatric illness

Primary outcomes:
measure: Behavioural Intervention Rating Scale (BIRS)
timeFrame: 10 weeks
Secondary outcomes:
measure: Client Credibility Questionnaire (CCQ)
timeFrame: 10 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Child Study Center
state: Connecticut
Study officials:
References:
Clinical trial NCT01156363: A Study of Monthly Subcutaneous or Intravenous Mircera in Dialysis Patients With Chronic Renal Anaemia
Official title: A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneous and Intravenous MIRCERA® for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-07-02
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This open label, single arm study will assess the efficacy for long-term maintenance of haemoglobin levels and the safety and tolerability of methoxy polyethylene glycol-epoetin beta \[Mircera\] in dialysis patients with chronic renal anaemia. Patients on regular long-term haemodialysis or peritoneal dialysis will receive monthly subcutaneous or intravenous Mircera for 6 months. Target sample size is \<200 patients.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>/=18 years of age
* chronic renal anaemia
* haemoglobin 10.0-12.0g/dl at screening
* adequate iron status
* continuous stable ESA (erythropoietic stimulating agent) therapy for \>/= 2 months
* regular haemodialysis or regular peritoneal dialysis for \>/= 3 months

Exclusion Criteria:

* uncontrolled hypertension
* haemoglobinopathy
* anaemia due to haemolysis
* pure red cell aplasia (PRCA)

Primary outcomes:
measure: Percentage of Participants Maintaining Average Hemoglobin (Hb) Concentration Within the Target Range
timeFrame: Weeks 1 to 32
Secondary outcomes:
measure: Mean Monthly Hb Values
timeFrame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8
measure: Change in Hb Concentration Between Reference and Treatment Period
timeFrame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8
measure: Mean Time Participants Spent Having Hb Concentration Within Target Range
timeFrame: Weeks 1 to 32
measure: Percentage of Participants Requiring Dose Adjustments
timeFrame: Baseline to Month 1; Month 1 to 2; Month 2 to 3; Month 3 to 4; Month 4 to 5; Month 5 to 6; Month 6 to 7; Month 7 to 8
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
city: New Taiepei City
country: Taiwan
city: Taichung
country: Taiwan
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04587063: Evaluation of Emails Promoting Mail-order Pharmacy
Official title: Evaluation of an Email Intervention Promoting Enrollment in Mail-order Pharmacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Care Utilization
Keywords: Pharmacy
Postal Service
Electronic Mail
Communication
Economics, Behavioral
Psychology
Loss Frames
Fear Appeals
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 5266
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 1 x 5 design
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In this evaluation, four versions of emails will be sent to eligible health plan members who are not currently enrolled in the health system's mail-order pharmacy. A control group will not receive any communication. The researchers hypothesize that the use of content informed by behavioral nudge theory in the emails should lead to increased enrollment in the health system's mail-order pharmacy.

Detailed description: The utilization of a mail-order pharmacy can increase adherence to medications. The health system's mail-order pharmacy (from here, simply referred to as mail-order pharmacy) can also provide reduced costs for medications. Ongoing outreach efforts involve sending emails and other communications encouraging enrollment in Geisinger's mail-order pharmacy to eligible members of the system's health plan (i.e., those who take maintenance medications). The study will compare a standard promotional email from these outreach efforts, as well as three new emails with content informed by behavioral science research, against a no-contact control arm and each other.

Eligibility criteria: Inclusion Criteria:

* An active member of the health plan (Medicare, Commercial, or Exchange)
* Currently prescribed maintenance medications
* Not currently subscribed to the health system's mail-order pharmacy
* Has an email on record

Exclusion Criteria:

* Explicitly opted out of receiving emails from the health system
* Only has eligible current prescriptions for fewer than 28 days
* Only has prescriptions that cannot be sent via mail-order pharmacy (e.g., antidepressants, specialty-tier drugs)
* Is a Medicare member in the coverage gap
* Shares an email address with another selected participant (who was randomly chosen for inclusion among all those sharing the same email address)

Primary outcomes:
measure: Mail-order Pharmacy Enrollment
timeFrame: 1 week from the intervention
Secondary outcomes:
measure: Email Opens
timeFrame: 1 week from the intervention
measure: Email Link Click
timeFrame: 1 week from the intervention
measure: Email Unsubscribes
timeFrame: 1 week from the intervention
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Amir Goren, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00220363: A Multicenter Trial to Investigate Fesoterodine Sustained Release in Overactive Bladder Syndrome
Official title: A Phase 3, Parallel Group, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled Multicenter Trial to Investigate the Efficacy, Tolerability and Safety of Fesoterodine Sustained Release in Subjects With Overactive Bladder Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overactive Bladder Syndrome
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The trial consisted of a 2 week Run-In period, 12 week double-blind Treatment period and 2 week Safety Follow-Up period. Subjects were randomized to one of 4 treatment arms receiving either fesoterodine (SPM 907) 4mg, fesoterodine 8mg, active control (tolterodine SR 4mg) or placebo during the Double-Blind Treatment Period.

Two primary efficacy variables will be assessed for submission in the United States: change in the average number of micturitions (frequency) per 24 hours and the change in the average number of urge incontinence episodes per 24 hours. For the submissions in the European Union, the first primary variable will be the change in the average number of micturitions (frequency) per 24 hours and the co-primary variable is the treatment response, based on a treatment benefit scale. All continuous variables will be measured as changes from baseline to value after 12 weeks of treatment.

The most important safety variables included the assessment of adverse events, laboratory parameters, changes in ECG, physical exams and measurement of residual urine.


Eligibility criteria: Inclusion Criteria:

* Overactive Bladder Syndrome

Exclusion Criteria:

* less than 8 micturitions in 24 hours

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Monheim
country: Germany
facility: Schwarz
Study officials:
affiliation: UCB Pharma
name: Axel Steinert
role: STUDY_DIRECTOR
References:
citation: Wagg AS, Herschorn S, Carlsson M, Fernet M, Oelke M. A plain language summary of the likelihood of symptom relief for patients taking fesoterodine for overactive bladder. J Comp Eff Res. 2022 Sep;11(13):919-925. doi: 10.2217/cer-2022-0041. Epub 2022 Jul 26.
citation: Cardozo L, Khullar V, El-Tahtawy A, Guan Z, Malhotra B, Staskin D. Modeling dose-response relationships of the effects of fesoterodine in patients with overactive bladder. BMC Urol. 2010 Aug 19;10:14. doi: 10.1186/1471-2490-10-14.
citation: Staskin D, Michel MC, Nitti V, Morrow JD, Wang J, Guan Z. Efficacy of fesoterodine over 24 hours in subjects with overactive bladder. Curr Med Res Opin. 2010 Apr;26(4):813-8. doi: 10.1185/03007990903585707.
Clinical trial NCT04224363: Whether it is More Appropriate to Spray Lugol's Solution From Cervical Esophagus to Esophagogastric Junction
Official title: Whether it is More Appropriate to Spray Lugol's Solution From Cervical Esophagus to Esophagogastric Junction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Squamous Cell Carcinoma
Keywords: Lugol's solution
staining sequence
Esophageal Squamous Cell Carcinoma
Effectiveness
Safety
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to compare the effectiveness and safety of spraying Lugol's solution from cervical esophagus to esophagogastric junction (downward) and from esophagogastric junction to cervical esophagus （upward）during chromoendoscopy.

Detailed description: Chromoendoscopy using Lugol's solution is effective for the detection of early esophageal squamous neoplasia. However, there is no study to investigate the sequence of Lugol's staining during endoscopic procedure.

The aim of this study is to compare the effectiveness and safety of spraying Lugol's solution from cervical esophagus to esophagogastric junction (downward) and from esophagogastric junction to cervical esophagus （upward）during chromoendoscopy.

Eligibility criteria: Inclusion Criteria:

* High risk patients of early esophageal squamous neoplasias.

Exclusion Criteria:

* After esophageal surgery or endoscopic treatment ;
* Known esophageal radiotherapy or chemotherapy ;
* Esophageal stenosis;
* Acute bleeding;
* A known allergy to iodine;
* Coagulopathy (prothrombin time \<50% of control, partial thromboplastin time \>50 seconds);
* Having food retention;
* Severe hepatic ,renal, cardiovascular or metabolic dysfunction ;
* Being pregnant or lactating.

Primary outcomes:
measure: Image Quality
timeFrame: intraoperative
Secondary outcomes:
measure: Adverse events
timeFrame: 24 hours
measure: Dose
timeFrame: intraoperative
measure: Effectiveness
timeFrame: 1 month
measure: Tolerance
timeFrame: intraoperative
Other outcomes:
Locations:
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Xiuli Zuo, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: