louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01161797: 1,5-AG as a Marker of Postprandial Hyperglycemia and Glucose Variability in Well-controlled Type 2 Diabetes Mellitus
Official title: Correlation Between 1,5-anhydroglucitol and Postprandial Hyperglycemia by Continuous Glucose Monitoring System and Clinical Usefulness of 1,5-anhydroglucitol in Well-controlled Diabetic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Keywords: 1,5-Anhydroglucitol
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
First posted: 2010-07-14
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Well-controlled patients with type 2 diabetes with HbA1c\<7%

Brief summary: The aim of this study was to evaluate the correlation between 1,5-Anhydroglucitol in patients with HbA1C \<7%, and glycemic excursions as assessed by the continuous glucose monitoring system compared to fructosamine.

Detailed description: 1,5-Anhydroglucitol (AG) is a glucose analogue present in the plasma of healthy subjects. Physiologically, the plasma levels of 1,5-AG are very stable and only a small quantity is excreted in the urine. It is competitively reabsorbed with glucose in the renal tubules. Therefore, in the hyperglycemic state where glycosuria is present, glucose competitively inhibits renal tubular reabsorption of 1,5-AG and consequently the plasma 1,5-AG levels decrease. When glycemia is normalized and glycosuria is resolved, 1,5-AG levels increase.

The usefulness of 1, 5-AG in reflecting glycemic excursions have been demonstrated in moderately controlled patients to some extent, although some studies reveal controversial results.

Therefore, the aim of this study was to evaluate the association of 1,5-AG and postprandial hyperglycemia determined using the Continuous Glucose Monitoring System (CGMS) in DM patients with HbA1C\<7% and evaluate the usefulness of 1,5-AG as a marker of glycemic control compared to HbA1C and fructosamine.

Eligibility criteria: Inclusion Criteria:

* HbA1C \< 7%
* HbA1c modification \<0.5% in the previous 3 months
* no recent addition of oral hypoglycemic medications or change in insulin dose \>10% previous 3 months

Exclusion Criteria:

* pregnancy
* anemia (Hb \<10.0 g/dL)
* liver disease (ALT \>2 UNL)
* hypoalbuminemia (albumin \<3.5 g/dL)
* serum creatinine \>2 mg/dL
* acute or chronic renal tubulointerstitial disease
* severe medical illness

Primary outcomes:
measure: postprandial hyperglycemia
timeFrame: 3days
measure: glucose variability
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyunghee University Medical Center
Study officials:
affiliation: Department of Endocrinology and Metabolism, Kyung Hee University School of Medicine, Seoul, Korea
name: Jeong-taek Woo, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03397797: Effect of Intraoperative Neuromuscular Blockade on Postoperative Sore Throat and Hoarseness
Official title: Effect of Intraoperative Neuromuscular Blockade on Postoperative Sore Throat and Hoarseness in Patients Undergoing Spinal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sore Throat
Keywords: muscle relaxant
Lead sponsor: SMG-SNU Boramae Medical Center
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 117
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients scheduled for elective lumbar spinal surgery

Brief summary: Investigators assess and compare postoperative sore throat and hoarseness in the group using the muscle relaxant and not using it during the operation.

Detailed description: The muscle relaxant is usually used during the operation to maintain moderate relaxation but, it can't be used in the surgery to need eletrophysiological monitoring during the operation. In this sturdy, the investigators assess the postoperative sore throat and hoarseness and compare the effect of muscle relaxant in the group using the muscle relaxant and not using it in terms of the incidence and severity of postoperative sore throat and hoarseness.

Eligibility criteria: Inclusion criteria

* patients scheduled to undergo elective lumbar spinal surgery Exclusion criteria
* known or predicted difficult airway
* neuromuscular diseases
* hepatic or renal dysfunction
* diseases or anatomical abnormalities in the neck, larynx, or pharynx
* requirement for postoperative mechanical ventilation

Primary outcomes:
measure: Overall cumulative incidence of postoperative sore throat
timeFrame: Within 24 hr evaluation period after operation
measure: Overall cumulative incidence of postoperative hoarseness
timeFrame: Within 24 hr evaluation period after operation
Secondary outcomes:
measure: Incidence of postoperative sore throat
timeFrame: At 1,6, and 24 hr after operation
measure: Severity of postoperative sore throat
timeFrame: At 1,6, and 24 hr after operation
measure: Incidence and severity of postoperative hoarseness
timeFrame: At 1,6, and 24 hr after operation
measure: Post operative analgesic consumption
timeFrame: within 24 hrs after operation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jee-Eun Chang
Study officials:
affiliation: SMG-SNU Boramae Medical Center
name: Jin-Yong Hwang, M.D.,Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04198597: Exploring Two Treatments for Misophonia
Official title: Exploring Two CBT-based Treatments as Interventions for Emotion Dysregulation in Misophonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Misophonia
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: While the investigators continue to work on better understanding Misophonia, it is also important to identify treatments that can help people who are currently suffering. Further, it is important that the treatments provided are acceptable to the people who receive them. In this study, participants will complete one of two treatments the investigators believe can help manage symptoms of Misophonia: The Unified Protocol or process-based therapy. Both treatments will use evidence-based psychological principles (e.g., managing attention or behavior) in a flexible manner and will focus on developing skills to help reduce the distress and impairment associated with Misophonia. The aims of this study are (1) to explore the acceptability and feasibility of these treatments for individuals who experience Misophonia and (2) to examine whether these treatments help reduce symptoms associated with Misophonia.


Eligibility criteria: Inclusion Criteria:

* Over age 18
* Able to read English
* Meet criteria for interfering symptoms of misophonia
* Live in North Carolina

Exclusion Criteria:

* Under age 18
* Current mania
* Current psychotic disorder
* Current anorexia
* Presents with a condition that requires immediate prioritization in treatment (e.g., suicide planning or intent)
* Has received any treatment specifically for misophonia in the past year

Primary outcomes:
measure: Number of patients that are satisfied with treatment as measured by the credibility and expectancy questionnaire (CEQ)
timeFrame: up to 20 weeks
measure: Number of patients who indicate treatment was acceptable to them (i.e., the treatment approach made sense and was perceived as reasonable)
timeFrame: up to 20 weeks
Secondary outcomes:
measure: Change in misophonia symptoms as assessed by the Misophonia Questionnaire
timeFrame: assessed weekly, up to 24 weeks
measure: Change in anxiety as measured by the Overall Anxiety Severity and Impairment Scale
timeFrame: assessed weekly, up to 24 weeks
measure: Change in depression as measured by the Overall Depression Severity and Impairment Scale
timeFrame: assessed weekly, up to 24 weeks
measure: Change in anger as measured by the Clinical Anger Scale
timeFrame: assessed weekly, up to 24 weeks
measure: Number of patients who use the skills taught in treatment as measured by the Skill Use Questionnaire
timeFrame: assessed weekly, up to 24 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Zachary Rosenthal, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04679597: Total Neoadjuvant Therapy Versus Standard Therapy of Locally Advanced Rectal Cancer With High Risk Factors for Failure
Official title: Total Neoadjuvant Therapy Versus Standard Therapy of Locally Advanced Rectal Cancer With High Risk Factors for Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Lead sponsor: Institute of Oncology Ljubljana
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all adult patients with newly diagnosed LARC with high risk factors for failure who were treated with TNT or standard therapy at the Institute of Oncology, Ljubljana, from 2016 to 2019

Brief summary: In a retrospective study, the investigators will compare patients with locally advanced rectal cancer with high risk factors for failure who were treated with standard therapy or with total neoadjuvant therapy.


Eligibility criteria: Inclusion Criteria:

* histologically proven locally advanced rectal cancer and
* the presence of one of the factors: T4, N2, positive mesorectal fascia, presence of extramural vascular invasion or presence of lateral lymph node.

Exclusion Criteria:

* distant metastases,
* concomitant malignancy,
* inflammatory bowel disease, or
* malabsorption syndrome.

Primary outcomes:
measure: pathological complete response
timeFrame: during surgery
Secondary outcomes:
measure: Neoadjuvant rectal cancer score
timeFrame: during treatment, assessed up to 10 days
Other outcomes:
measure: number of participants who completed treatment
timeFrame: during treatment, assessed up to 10 days
measure: number of participants with acute side effects
timeFrame: during treatment, assessed up to 10 days
Locations:
Study officials:
References:
Clinical trial NCT01048697: Effect of Weight and/or Obesity on Ethambutol Drug Concentrations
Official title: Population Pharmacokinetics Analysis of Ethambutol in Overweight and Obese Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Tuberculosis
Keywords: Obesity
Pharmacokinetics
Pharmacodynamics
Dose individualization
Tuberculosis
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
name: University of Texas Southwestern Medical Center
First posted: 2010-01-14
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This study is designed to measure drug concentrations in the blood of healthy volunteers administered a single dose of ethambutol. Our hypothesis is that volunteers with a body mass index (BMI) 25-40 kg/m2 will remove ethambutol more quickly from the blood than leaner volunteers, and those with a BMI \> 40 kg/m2 will have even greater clearance than those who are leaner.


Eligibility criteria: Inclusion Criteria:

* Male and female volunteers, age 18 years of age or older, of all racial and ethnic origins. English and/or Spanish speaking volunteers are eligible to participate.
* We are recruiting 6 normal weight (BMI \<25 kg/m2), 6 obese (BMI 25-40 kg/m2), and 6 extremely obese (BMI \> 40 kg/m2) for this study. Half of each group will be male, the other half will be female.

Exclusion Criteria:

* Creatinine clearance \< 70 ml/min as estimated by the Cockcroft-Gault equation.
* Pregnant or nursing or unwilling to use a reliable contraception method during the study period. The effects of ethambutol on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of ethambutol, so that the pregnancy and post-partum state would be a confounding variable.
* Abnormal liver function tests: transaminases \>10 time the upper limit of normal, alkaline phosphatase \> 5 time the upper limit of normal, total bilirubin \>5 time the upper limit of normal.
* History of allergy to ethambutol.
* Ethambutol is contraindicated for any reason.
* Suspected or documented mycobacterial infection.
* History of gout.

Primary outcomes:
measure: Total Clearance of Ethambutol
timeFrame: Blood samples will be collected over a 24 hour period (0, 2, 6, 11, 18, and 24 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: Texas Tech University HSC
name: Ronald Hall, PharmD, MSCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hall RG 2nd, Swancutt MA, Meek C, Leff RD, Gumbo T. Ethambutol pharmacokinetic variability is linked to body mass in overweight, obese, and extremely obese people. Antimicrob Agents Chemother. 2012 Mar;56(3):1502-7. doi: 10.1128/AAC.05623-11. Epub 2011 Dec 12.
Clinical trial NCT01653197: Evive Health Randomized Controlled Trials
Official title: Evive Health Randomized Controlled Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: People Due for Mammogram
People Due for Colonoscopy
People Due for Blood Pressure Test
People Due for Cholesterol Test
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2012-07-30
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The mailer will encourage those who are due for mammograms, colonoscopies, blood pressure or cholesterol tests to receive the appropriate test. This particular mailer will only be sent to Evive clients in need to the test in question. The research will examine differences in follow-through on this recommendation among the targeted population over the 3-12 month period following the mailing as a function of experimental condition.


Eligibility criteria: Inclusion Criteria:

* Employee at partner corporation
* Due for mammogram, colonoscopy, blood pressure or cholesterol test

Exclusion Criteria:

* Already received mammogram, colonoscopy, blood pressure or cholesterol test

Primary outcomes:
measure: Number of Participants who follow-through from the mailing
timeFrame: three to twelve months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00870597: Transconjunctival Sutureless 25-Gauge Vitrectomy
Official title: Transconjunctival Sutureless 25-Gauge Vitrectomy for Visually Significant Vitreous Floaters in Patients With Multifocal Intraocular Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Visual Acuity
Keywords: Floaters
multifocal IOL
visual complaints
vitrectomy
Lead sponsor: Hospital Oftalmologico de Brasilia
Sponsor class: OTHER
Collaborators: name: Federal University of Minas Gerais
First posted: 2009-03-27
Enrollment: 14
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate the role of 25-gauge transconjuntival sutureless vitrectomy (TSV) in patients with persistent vitreous floaters who underwent multifocal intraocular lens (IOL) implantation.

Detailed description: Purpose: The aim of this study was to evaluate the role of 25-gauge transconjuntival sutureless vitrectomy (TSV) in patients with persistent vitreous floaters who underwent multifocal intraocular lens (IOL) implantation.

Setting: Hospital Oftalmológico de Brasília, Brasília, DF, Brazil.

Methods: Fourteen eyes of 11 patients with multifocal IOL implant associated with vitreous opacities that underwent 25-gauge vitrectomy were prospectively analyzed. Information collected included near and distance uncorrected visual acuity (UCDVA), best corrected distance visual acuity (BCDVA), and the spherical equivalent (SE) before and 3 months after vitrectomy. Patients were questioned about surgery satisfaction and visual improvement after vitrectomy.

Eligibility criteria: Inclusion Criteria:

* disabling vitreous floaters
* Age-related cataract Unsatisfactory correction with glasses

Exclusion Criteria:

* central endothelial cell count less than 2000 cells/mm2
* glaucoma or intraocular pressure greater than 21 mmHg
* amblyopia
* retinal abnormalities
* diabetes mellitus
* steroid or immunosuppressive treatment
* connective tissue diseases

Primary outcomes:
measure: The aim of this study was to evaluate the role of 25-gauge transconjuntival sutureless vitrectomy (TSV) in patients with persistent vitreous floaters who underwent multifocal intraocular lens (IOL) implantation
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Brasília
country: Brazil
facility: Hospital Oftalmologico de Brasilia
state: DF
Study officials:
affiliation: Federal University of Minas Gerais
name: PATRICK TZELIKIS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06292897: Using Tissue-based Spatial Data to Understand How Obesity-related Tumor Metabolites Fuel Prostate Cancer Progression
Official title: Integrating Tissue-based Spatial Information to Elucidate How Obesity-induced Tumour Metabolites Drive Prostate Cancer Progression
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Prostate Adenocarcinoma
Prostate Neoplasm
Prostatic Neoplasm
Obesity
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
Collaborators: name: National Research Council
First posted: 2024-03-05
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients affected bt prostate cancer both obese or not obese

Brief summary: Evaluate the protein expression of lactate dehydrogenase enzyme (LDHA) and MCT-1/-4 transporters, involved in lactate synthesis and transport, in prostate carcinoma tissues from severely overweight/obese (BMI \> 27.5) and non-severely overweight/normoweight (BMI \< 27.5) patients affected by prostate carcinoma.

ii. Characterize the immune infiltrate in the prostate carcinoma of the aforementioned patients.

iii. Assess the association between intra-tumoral lactate accumulation (using LDHA and MCT-4 protein expression levels as readouts) and alterations in the tumor immune microenvironment and/or deregulation of relevant oncogenic pathways.


Eligibility criteria: Inclusion Criteria:

* affected by prostate cancer

Exclusion Criteria:

-

Primary outcomes:
measure: Assess the protein expression of LDHA enzyme and MCT-1/-4 transporters in prostate carcinoma
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Cà Granda Ospedale Maggiore Policlinico Milano
Study officials:
References:
Clinical trial NCT02993497: Respiratory Measurement Using Infrared Camera and Respiratory Volume Monitor (ExSpiron 1Xi) for Sedation in Patients Undergoing TURP/TURB Under Spinal Anesthesia
Official title: Respiratory Measurement Using Infrared Camera and Respiratory Volume Monitor (ExSpiron 1Xi) for Sedation in Patients Undergoing TURP/TURB Under Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Bladder Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-12-15
Enrollment: 20
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: In patients undergoing spinal anesthesia, the investigators used an Infra-red camera and a respiratory volume monitor to determine the accuracy of the ventilation rate of the infra red camera by measuring the respiratory rate, ventilation volume, and ventilation volume with respiratory volume monitor.


Eligibility criteria: Inclusion Criteria:

* An adult male who underwent endoscopic prostatectomy resection with regular surgery
* An adult male who underwent endoscopic bladder resection with regular surgery

Exclusion Criteria:

* Presenting alteration in respiratory function detected by functional analysis of lung volume and capacity- pneumonectomy patient, severe ipsilateral destroyed lung patient
* Inability to understand or perform the procedure
* ASA(American Society of Anesthesiologists) class 4,5

Primary outcomes:
measure: The accuracy of breathing measurements
timeFrame: Intraoperative period about 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT04517305: Pyrotinib Plus Vinorelbine in HER2+ Metastatic Breast Cancer Patients
Official title: Pyrotinib Plus Vinorelbine in Metastatic HER2-positive Breast Cancer Patients- a Multicenter Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Pyrotinib
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2020-08-18
Enrollment: 97
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with breast cancer (according to International Classification of Diseases-10, ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.

Brief summary: To evaluate the patterns and treatment outcomes of pyrotinib plus vinorelbine in the real world.


Eligibility criteria: Inclusion Criteria:

* woman, age \> 18 years old
* diagnosed with HER2 +Metastatic Breast Cancer
* pyrotinib plus vinorelbine for at least one cycle, starting from 2018.05-2020.05
* available medical history

Exclusion Criteria:

* medical history was incomplete

Primary outcomes:
measure: PFS
timeFrame: 6 weeks
measure: Adverse events
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Biyun Wang, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li Y, Qiu Y, Li H, Luo T, Li W, Wang H, Shao B, Wang B, Ge R. Pyrotinib Combined With Vinorelbine in HER2-Positive Metastatic Breast Cancer: A Multicenter Retrospective Study. Front Oncol. 2021 Apr 20;11:664429. doi: 10.3389/fonc.2021.664429. eCollection 2021.