louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02076347: Comparison of Two Pharmacist-led Population Management Approaches to Increase Monitoring of Vitamin B12 and Serum Creatinine Levels for Patients on Metformin
Official title: Comparison of Two Pharmacist-led Population Management Approaches to Increase Monitoring of Vitamin B12 and Serum Creatinine Levels for Patients on Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Vitamin B12 Deficiency
Neuropathy
Anemia
Keywords: Metformin
Vitamin B12 Deficiency
Population Management
Pharmacist
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2014-03-03
Enrollment: 489
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of this project is to compare two pharmacist-led population management strategies designed to increase the rate of appropriate monitoring of vitamin B12 and serum creatinine for patients taking metformin.


Eligibility criteria: Inclusion Criteria:

* On Metformin for at least one year
* Activated patient portal for electronic messaging
* Patient of an attending physician at Ohio State General Internal Medicine
* No serum vitamin B12 and/or no serum creatinine measurement in the past year

Primary outcomes:
measure: Percentage of patients in each arm who obtain monitoring of vitamin B12 as recommended
timeFrame: 6 months
Secondary outcomes:
measure: Number of patients with newly identified vitamin B12 deficiency
timeFrame: 6 months
measure: Percentage of patients with newly identified vitamin B12 deficiency who have prior evidence of anemia upon chart review
timeFrame: within 6 months
measure: Percentage of patients with newly identified vitamin B12 deficiency who have prior evidence of neuropathy upon chart review
timeFrame: within 6 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University General Internal Medicine
state: Ohio
Study officials:
References:
citation: Matthews DE, Beatty SJ, Grever GM, Lehman A, Barnes KD. Comparison of 2 Population Health Management Approaches to Increase Vitamin B12 Monitoring in Patients Taking Metformin. Ann Pharmacother. 2016 Oct;50(10):840-6. doi: 10.1177/1060028016655180. Epub 2016 Jun 20.
Clinical trial NCT03922347: mHealth Intervention for Improving Eye Health at Community Level
Official title: Modelling and Evaluation of a Community-oriented mHealth-based Screening and Promotional Programme for Improving Eye Health in Iran
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Visual Impairment
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 3300
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a community trial that aims to establish and evaluate an mHealth screening and promotional tool for improving eye health in Iran. Sampling frame is a region in Tehran province with around 1 million sub-urban and rural inhabitants. investigators have obtained the list of health centers and their underserved population from the health authorities. In this region, health services are delivered through rural health houses, urban health posts and overhead health centers (221 units in total). investigators choose 27 units using cluster random sampling method with a probability proportional to size strategy, then investigators randomly assign them into three arms (explained below). The interventions will be at community level with the community as the unit of randomization.

Arm 1- Training of the Primary Health Care (PHC) workers + PHC workers will be empowered with the mHealth tool to monitor, screen and promote community members Arm 2- PHC system will be strengthened with health promotion and screening programmes (same content as the mHealth tool) and PHC workers will deliver eye health messages and screening tests by the conventional facilities.

Arm 3: Control group: only observation and registering of routine care


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria were living in one of the non-institutionalized urban or rural residential areas in one of the survey area, being resident in the same address for at least 6 months during the year before the enrolment, age 50 and over and Iranian nationality.

Primary outcomes:
measure: Eye care utilization: being visited/treated by an eye care professional
timeFrame: 6-12 months
Secondary outcomes:
measure: Visual acuity
timeFrame: At baseline
measure: fundus imaging
timeFrame: At baseline
measure: Based on Logarithm Minimum Angle of Resolution, LogMAR. Visual acuity will be presented in range (minimum to maximum). Higher value of visual acuity represents the worsened outcome.
timeFrame: At baseline
measure: fundus imaging by fundus photography (Visucam Pro NM; Carl Zeiss Meditec AG, Germany)
timeFrame: At baseline
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research Center
Study officials:
References:
Clinical trial NCT05381298: Deep Margin Elevation Vs Crown Lengthening
Official title: Biological Evaluation of Indirect Restorations in Endodontically-treated Posterior Teeth With Deeply Located Proximal Margins Following Deep Margin Elevation Versus Surgical Crown Lengthening: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endodontically Treated Teeth
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present clinical trial will be conducted to reject or accept the null hypothesis that in endodontically treated posterior teeth with deeply located proximal margins, will the Deep Margin Elevation will have better results from surgical crown lengthening in terms of biological criteria?


Eligibility criteria: Inclusion Criteria:

* Patients underwent endodontic treatment in the posterior region
* 18-40 years
* Male and Females
* Medically free patients
* Patients with healthy periodontium
* Patients with thick biotype.
* Patients having proximal margins violating the biological width

Exclusion Criteria:

* Patients with chronic periodontal disease.
* Patients with persistent poor oral hygiene.
* Patients with unsuccessful root canal treatment.
* Periapical Abscess or Fistula.
* Patients with proximal margins beyond the bone level.
* Patients with developmental dental anomalies.
* Patients undergoing or will start orthodontic treatment
* Patients with removable prosthesis

Primary outcomes:
measure: Clinical Attachment Level
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT05065398: A Phase II Clinical Trial to Evaluate HLX208 in Advanced Non-small Cell Lung Cancer Patients With BRAF V600 Mutation
Official title: An Open Label， Multicenter Phase II Clinical Trial to Evaluate the Efficacy，Safety and Pharmacokinetics of HLX208 in Advanced Non-small Cell Lung Cancer Patients With BRAF V600 Mutation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: NSCLC
Lead sponsor: Shanghai Henlius Biotech
Sponsor class: INDUSTRY
First posted: 2021-10-04
Enrollment: 20
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: Evaluate the efficacy，safety and pharmacokinetics of HLX208 in advanced non-small cell lung cancer patients with BRAF V600 mutation


Eligibility criteria: Inclusion Criteria:

* Age\>=18Y
* Good Organ Function
* Expected survival time ≥ 3 months
* advanced BRAF V600 NSCLC that have been diagnosed histologically or cytology and have failed standard treatment or unable to receive, or refusing standard care.
* Previous failure to standard treatment, or insuitability for standard treatment or refuse standard treatment.
* ECOG score 0-2;
* Exclusion Criteria:
* Previous treatment with BRAF inhibitors or MEK inhibitors
* Presence of EGFR mutations or ALK rearrangements (unless disease progression following prior treatment with tyrosine kinase inhibitors).
* Symptomatic brain or meningeal metastases (unless the patient has been on \> treatment for 1 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable).
* Current or former patients with interstitial lung disease;
* Severe active infections requiring systemic anti-infective therapy
* A history of other malignancies within two years, except for cured cervical carcinoma in situ, basal cell carcinoma of the skin, adenocarcinoma in situ of the lung, or tumors that do not require interventional treatment after radical surgery.
* Other anti-tumor treatments, such as chemotherapy, targeted therapy, or radiation therapy (except palliative radiation therapy), may be given during the study period.

Primary outcomes:
measure: ORR
timeFrame: from first dose to the last patient was followed up for 6 month
Secondary outcomes:
measure: PFS
timeFrame: the time (month is regarded as the unit) from the first dose to the date of first documented progression or date of death from any cause, whichever came first,through treatment completion, an average of about 1 year
measure: DOR
timeFrame: from the first occurrence of a documented CR or PR (whichever recorded earlier) to the time of first documented disease progression or death (whichever occurs first),through treatment completion, an average of about 1 year
measure: OS
timeFrame: from the first dose to the time of death due to any cause, an average of about 2 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai chest hospital
Study officials:
References:
Clinical trial NCT01749098: A Study To Examine The Effects Of PF-04958242 On Ketamine-Induced Cognitive Impairment In Healthy Volunteers
Official title: A Randomized, Subject And Investigator Blinded, Sponsor Open Placebo Controlled, 2 Way, Crossover Phase 1b Study To Examine The Effects Of PF-04958242 On Ketamine Induced Cognitive Impairment In Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Keywords: PF-04958242
ketamine
cognition
healthy volunteers
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2012-12-13
Enrollment: 29
Sex: MALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: To assess if PF-04958242 can attenuate the ketamine-induced cognitive impairment in verbal learning and memory, episodic memory and spatial working memory in healthy volunteers.

Detailed description: This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

Eligibility criteria: Inclusion Criteria:

* Healthy male subjects 21 - 45 years old.
* Able to read and write English as primary language.
* Subjects who are willing to comply with study procedures.

Exclusion Criteria:

* History of any substance abuse or dependence disorder meeting DSM-IV criteria and/or by SCID-NP within the past 12 months, with the exception of nicotine.
* Known sensitivity to ketamine
* Any history of DSM-IV Axis I psychiatric disorders, determined by SCID-NP interview or diagnoses in the view of the investigator.

Primary outcomes:
measure: Test score on the Hopkins Verbal Learning Test - Immediate Recall
timeFrame: Day 5
Secondary outcomes:
measure: Test score on the Weschler Digit Span Test
timeFrame: Day 5
measure: Test score on the CogState N-back test
timeFrame: Day 5
measure: Test score on the CogState Spatial Working memory test
timeFrame: Day 5
measure: Test score on the CogState One Card Learning test
timeFrame: Day 5
measure: Test score on the Hopkins Verbal Learning test - Delayed Recall
timeFrame: Day 5
measure: Retrospective rating on the Positive and Negative Syndrome Scale -modified scale'
timeFrame: Day 5
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: West Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04880798: Effect of Thyrotropin Level on Iodine Uptake in Metastatic Differentiated Thyroid Cancer
Official title: Effect of Thyrotropin Level on Iodine Uptake: a Prospective 124I PET/CT Study in Metastatic Differentiated Thyroid Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Differentiated Thyroid Cancer
Keywords: differentiated thyroid cancer
pulmonary metastases
bone metastases
thyrotropin
thyroid stimulating hormone
124I PET/CT
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Peking University Cancer Hospital & Institute
First posted: 2021-05-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Distant metastases is the leading cause of differentiated thyroid cancer-related death. Radioactive iodine (RAI) treatment is the most effective therapy for RAI-avid metastatic differentiated thyroid cancer (DTC). It is well known that the efficacy of RAI therapy is depend on the sodium-iodide symporter protein, which can be synthesized by elevated thyrotropin stimulation. Therefore, thyrotropin stimulation before RAI treatment to ensure sufficient uptake of RAI has been a long-established procedure. According to some observational studies, thyrotropin of 25-30 μIU/mL has been adopted as the standard care protocol. However, whether thyrotropin of 25-30 μIU/mL is enough to stimulate iodine uptake in metastatic lesions remains unknown. In this study, the investigators aim to address the effect of thyrotropin on iodine uptake in metastatic DTC during levothyroxine withdrawal by two times 124I PET/CT scans on different endogenous thyrotropin levels.

Detailed description: It is estimated that 10 patients who met the study criteria will be enrolled. All patients underwent twice 124I PET/CT scans in Beijing Cancer Hospital. The first 124I PET/CT was prepared with endogenous thyrotropin 30±10 μIU/mL, the second 124I PET/CT was prepared with endogenous thyrotropin \>100 μIU/mL. The RAI-avidity of the metastases was assessed twice along with the levothyroxine withdrawal by 124I PET/CT scans.

Eligibility criteria: Inclusion Criteria:

1. Patients underwent total thyroidectomy.
2. Patients were diagnosed with differentiated thyroid cancer by postoperative pathological examination.
3. Distant metastases confirmed by CT etc.

Exclusion Criteria:

1. Pregnancy or lactation.
2. Significant hepatic or renal dysfunction;
3. Unable to lie flat, still or tolerate a PET scan.

Primary outcomes:
measure: Effect of thyrotropin level on iodine uptake in metastatic DTC lesions on twice 124I PET/CT.
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
Study officials:
References:
Clinical trial NCT05469698: Onsite Tobacco Cessation Treatment for Patients With PAD
Official title: Onsite Tobacco Cessation Treatment for Patients With Peripheral Artery Disease (PAD): A Feasibility Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tobacco Cessation
Peripheral Artery Disease
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2022-07-22
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Tobacco cessation treatment is needed for individuals with peripheral artery disease (PAD) to improve symptoms, lower cardiovascular risk, and prevent amputation. While such treatment is effective, many PAD patients do not receive cessation therapy. Participants will receive nicotine replacement therapy, counseling, and and complete questionnaires. We hypothesize that integrating tobacco cessation services into a dedicated PAD clinic (OU CVI Limb Preservation Clinic) can improve tobacco cessation rates and improve PAD-related health outcomes in this at risk population.


Eligibility criteria: Inclusion Criteria:

* Have diagnosed peripheral artery disease
* Tobacco user
* 18 years of age or older
* Willing/able to attend all study visits
* Be able to read, speak, and understand English

Exclusion Criteria:

* Do not meet the specified inclusion criteria above

Primary outcomes:
measure: Biochemically confirmed abstinence
timeFrame: 13 weeks post enrollment
Secondary outcomes:
measure: Rate of enrollment
timeFrame: Duration of the study (approximately 6 months)
Other outcomes:
measure: Improvements in PAD
timeFrame: Baseline to 13 weeks post enrollment
Locations:
city: Oklahoma City
country: United States
facility: TSET Health Promotion Research Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Darla E Kendzor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06954298: Molecular Landscape of Complex Lifestyle Modification
Official title: Metabolic Dysregulation as the Underlying Principle of Integrated Pathophysiology of Obesity-associated Chronic Diseases: Molecular Landscape of Complex Lifestyle Modification
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity Prevention
Obesity
Metabolic Disease
Keywords: lifestyle intervention
exerkines
metabolic flexibility
Lead sponsor: Slovak Academy of Sciences
Sponsor class: OTHER_GOV
Collaborators: name: Medical University Vienna
First posted: 2025-05-01
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to detect the impact of the 3-month complex lifestyle intervention, consisting of dietary counselling, supervised exercise training and cognitive-behavioural intervention in middle-aged sedentary individuals with obesity, specific questions are:

* What is the adaptive response to exercise training on the whole-body and skeletal muscle energy metabolism, insulin sensitivity, metabolic flexibility, muscle functional parameters and cardiopulmonary fitness?
* Would the intensity-related changes of the exercise-induced substrate preference (lipids vs carbohydrates) be a good predictive marker of metabolic flexibility i.e. the capacity to reduce the whole-body metabolic burden in patients with obesity?
* Is the signal driving the adaptive response to regular exercise contained in serum derived Extracellular vesicles?

Researchers will examine effects of exercise training intervention on whole body energy metabolism, by integrating clinical, biochemical and molecular data.

Participants will:

* Undergo 3 months exercise - intervention program.
* Be submitted to examination of their obesity, energy metabolism and cardiopulmonary fitness related phenotypes using bioelectric impedance, indirect calorimetry, cycle spiroergometry.
* Blood samples will be taken both, at the baseline PRE- and POST- intervention.


Eligibility criteria: Inclusion Criteria: BMI 30-45 kg.m-2 -

Exclusion Criteria: smoking, cancer,

-

Primary outcomes:
measure: Metabolic flexibility in response to submaximal exercise and nutritional challenge
timeFrame: 24 months
Secondary outcomes:
measure: cardiopulmonary fitness (VO2max)
timeFrame: 24 months
measure: Index of insulin resistance (oGTT)
timeFrame: 24 months
measure: abdominal adiposity and abdominal adipose tissue distribution (subcutaneous / visceral)
timeFrame: 24 months
Other outcomes:
Locations:
city: Bratislava
country: Slovakia
facility: Center for Obesity Management EASO, Biomedical Research Center SAS
Study officials:
affiliation: Biomedical Research Center Slovak Acad Sci
name: Barbara Ukropcová, Prof. MD PhD
role: STUDY_CHAIR
affiliation: Biomedical Research Center Slovak Acad Sci
name: Jozef Ukropec, PhD, DSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01275898: Comparison of INVOS and FORE SIGHT Cerebral Oximeter
Official title: Assessing Cerebral Oxygenation During Different Surgical Procedures - Comparison of INVOS and ForeSight Cerebral Oximeter
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Changes in Cerebral Oxygenation During Different Patient Positioning
Coparison of Two Cerebral Oximeters
Keywords: NIRS
cerebral oxygenation
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2011-01-13
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for surgical intervention in beach chair position, prone position and head down position

Brief summary: Cerebral oxygenation can be monitored using near infrared spectroscopy. Different devices are available to assess cerebral oxygenation noninvasively. Beach chair position is assumed to influence cerebral oxygenation. Litte is known about the influence of prone position and head down position on cerebral oxygenation. The investigators hypothesize that these positions influence cerebral oxygenation. Further the investigators presume that the two cerebral oximeters INVOS and ForeSight provide comparable oxygenation data.


Eligibility criteria: Inclusion Criteria:

age \>18 and \<80 years written informed consent

Exclusion Criteria:

cerebrovascular disease coronary heart disease severe organ failure hemoglobin \< 10mg/dl injury of forehead pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Klinik für Anaesthesiologie Universitätsmedizin Mainz
Study officials:
References:
citation: Schramm P, Tzanova I, Hagen F, Berres M, Closhen D, Pestel G, Engelhard K. Cerebral oxygen saturation and cardiac output during anaesthesia in sitting position for neurosurgical procedures: a prospective observational study. Br J Anaesth. 2016 Oct;117(4):482-488. doi: 10.1093/bja/aew250. Epub 2016 Oct 17.
citation: Closhen D, Engelhard K, Dette F, Werner C, Schramm P. Changes in cerebral oxygen saturation following prone positioning for orthopaedic surgery under general anaesthesia: a prospective observational study. Eur J Anaesthesiol. 2015 Jun;32(6):381-6. doi: 10.1097/EJA.0000000000000259.
citation: Closhen D, Treiber AH, Berres M, Sebastiani A, Werner C, Engelhard K, Schramm P. Robotic assisted prostatic surgery in the Trendelenburg position does not impair cerebral oxygenation measured using two different monitors: A clinical observational study. Eur J Anaesthesiol. 2014 Feb;31(2):104-9. doi: 10.1097/EJA.0000000000000000.