louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04923386: mRNA Based-Covid-19 Vaccine Effects on Blood Glucose Levels
Official title: Effect of mRNA Based-Covid-19 Vaccine on Blood Glucose Levels Recorded by Continuous Glucose Monitoring in Patients With a History of Diabetes Mellitus Type I and Type II.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Hyperglycemia
Vaccine Adverse Reaction
Keywords: mRNA Vaccine
Hyperglycemia
Hypoglycemia
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
COVID-19 Vaccine
Lead sponsor: Levenson, David I., M.D.
Sponsor class: INDIV
First posted: 2021-06-11
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible patients in the PI's database.

Brief summary: To determine if patients with a history of Diabetes Mellitus Type I or II developed a change in blood glucose levels as reported on Continuous glucose monitoring devices (CGMS) within the first week following administration of each dose of the COVID-19 vaccine.

Detailed description: A retrospective review of all patient data from the Dexcom and Libre CGMS devices available at a single site, solo endocrinology practice will be obtained. This data will include fasting morning glucose, postprandial glucose, and daily glucose area under the curve for seven days following vaccination administration, as well as daily glucose area under the curve seven days prior to vaccine administration that will be used as a control. Patients \>=18 y/o with a history of Diabetes Mellitus Type I or Type II will be selected. Brand of vaccine administered (Moderna or Pfizer-BioNTech) and the change in average blood glucose, peak blood glucose, and percentage of time spent in normal range as well as above average range of blood glucose level following vaccine administration will be assessed. Patients will fill out a visual analog symptom scale based on how symptomatic and uncomfortable they were following each dose of the COVID-19 vaccine. Patients will describe side effects that they experienced following each dose of the COVID-19 vaccine.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Diabetes Mellitus Type I or Type II
* Received the Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine

Exclusion Criteria:

* Patients \<18y/o.
* Patients that did not receive a COVID-19 vaccine.
* Patients who did not have a CGMS downloaded for a week prior and a week after vaccination.

Primary outcomes:
measure: Change in AUC glucose level above expected baseline
timeFrame: 7 days
Secondary outcomes:
measure: Change in peak glucose level above expected baseline
timeFrame: 7 days
measure: Change in fasting blood glucose levels above expected baseline
timeFrame: 7 days
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: East Coast Medical Associates
state: Florida
Study officials:
affiliation: East Coast Medical Associates
name: David I Levenson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05500586: The Effects of Glucagon on Hepatic Metabolism
Official title: The Effects of Glucagon on Hepatic Metabolism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Obesity
Type2diabetes
NAFLD
Keywords: glucagon
insulin resistance
hepatic steatosis
amino acid metabolism
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-08-15
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All subjects will undergo one study designed to measure the hepatic response to glucagon. There will be 3 groups non-diabetic and non-obese, obese, people with type 2 diabetes
Primary purpose: BASIC_SCIENCE

Brief summary: Whether impaired postprandial glucagon suppression in prediabetes and T2DM is an attempt to overcome resistance to glucagon's actions on hepatic AA catabolism, a defect in α-cell function, or a combination of both are important, unanswered questions. NAFLD is associated with T2DM risk and impaired insulin action. Unfortunately, it is unclear if glucagon resistance is caused by obesity, hepatic steatosis or both. The experiments outlined will determine if glucagon's actions on hepatic amino acid catabolism and EGP interact with hepatic lipid metabolism in lean and obese subjects with and without T2DM (and with varying degrees of hepatic steatosis).

Detailed description: T2DM and prediabetes are characterized by abnormal post-prandial suppression of glucagon, which contributes to postprandial hyperglycemia by increasing EGP. Although these effects are magnified by decreased and delayed insulin secretion, they are also apparent when insulin secretion is intact. In rodents, altered glucagon signaling changes α-cell function and mass - an effect mediated by changes in circulating AA concentrations. Are the elevated concentrations of branched-chain AA and other AA metabolites in T2DM a cause or an effect of global α-cell dysfunction? Could altered glucagon signaling precipitate a vicious cycle resulting in T2DM?

Eligibility criteria: Inclusion Criteria:

* Willing to participate
* Able to give consent

Exclusion Criteria:

* History of prior upper abdominal surgery e.g. gastric banding, pyloroplasty, vagotomy.
* Active systemic illness or malignancy.
* Symptomatic macrovascular or microvascular disease.
* Contraindications to MRI (e.g. metal implants, claustrophobia).
* Hematocrit \< 35%
* TSH \< 0.4 or \> 5.5.
* Consumption of \> 2 alcohol drinks per day or \> 14 per week or a positive AUDIT questionnaire

Primary outcomes:
measure: Rate of Amino acid catabolism in the presence / absence of glucagon
timeFrame: 240 minutes of study
Secondary outcomes:
measure: Effect of Diabetes on amino-acid catabolism
timeFrame: 240 minutes of study
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Adrian Vella
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00479986: Effects of Pioglitazone in Type 2 Diabetes Mellitus and Coronary Heart Disease
Official title: Effects of Pioglitazone in Patients With Type 2 Diabetes Mellitus and Coronary Heart Disease at High Risk for Vascular Complications : A Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Cardiovascular Disease
Keywords: diabetes mellitus
monocyte activation
cardiovascular risk
Lead sponsor: IKFE Institute for Clinical Research and Development
Sponsor class: OTHER
Collaborators: name: Takeda
name: Johannes Gutenberg University Mainz
name: Heidelberg University
First posted: 2007-05-30
Enrollment: 92
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of the study is to investigate the impact of a 4 week treatment with pioglitazone (in comparison to placebo) on biomarkers for atherosclerosis and cardiovascular risk, as well as the degree of activation of the immune system, when given on top of an anti-diabetic treatment (metformin and/or sulfonylurea drugs) that has already resulted in good glycemic control.

Detailed description: PPARgamma activation by pioglitazone has shown to be associated with an improvement of cardiovascular risk when measured with clinical (assessement of intima-media-thickness) or biochemical (hsCRP, MMP-9 etc.) markers. Well controlled patients (HbA1c \< 8.0 %) will receive either pioglitazone or placebo (randomised, double-blind) for 4 weeks. Blood will be drawn to investigate the change in cardiovascular or metabolic markers and mRNA will be isolated from circulating mononuclear cells to investiagte the degree of activation of the immune system, which is another measure for the risk of atherosclerosis development.

Eligibility criteria: Inclusion Criteria:

* type 2 diabetes mellitus
* stable oral treatment with metfromin and/or sulfonylurea
* age 20 - 80 years
* angiographically confirmed atherosclerosis or hsCRP \> 1 mg/l

Exclusion Criteria:

* type 1 diabetes
* HbA1c \> 8.5 %
* severe disease
* acute coronary syndrome
* contraindications to pioglitazone (heart failure etc.)

Primary outcomes:
measure: Short-term effect of Pioglitazone on Markers of vascular risk (MMP-9, hsCRP, monocyte activation)
timeFrame: 4 weeks
Secondary outcomes:
measure: Safety
timeFrame: 4 weeks
measure: Metabolic control (HbA1c, Glucose)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Dr. Michael Morcos
city: Mainz
country: Germany
facility: IKFE
Study officials:
affiliation: IKFE - Institute for Clinical Research and Development, Mainz
name: Thomas Forst, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IKFE - Institute for Clinical Research and Development, Mainz
name: Andreas Pfützner, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00183586: Comparing the Effectiveness of Three Types of Therapy for the Treatment of Anorexia Nervosa in Adolescents
Official title: Treatment for Adolescent Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Eating Disorders
Keywords: Treatment outcomes study
Anorexia
Anorexia nervosa
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-09-16
Enrollment: 121
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will compare specific family therapy, standard family systems therapy, and standard individual psychotherapy to determine which is most effective in treating adolescent anorexia nervosa.

Detailed description: In adolescents, anorexia nervosa severely affects physical, emotional, and social development. Despite the seriousness and prevalence of adolescent anorexia nervosa, few studies have focused on the effectiveness of various types of psychotherapy treatment. Family-based therapy may be an effective approach to treating adolescent anorexia nervosa. This study will compare specific family therapy (FT), standard family systems therapy (FS), and standard individual psychotherapy (IT) to determine which is most effective in treating adolescent anorexia nervosa. The study also aims to determine potential predictors and moderators of outcomes, as well as the cost-benefit ratio of each treatment.

Participants in this open-label study will be randomly assigned to one of three treatment groups. Group 1 will receive FT, Group 2 will receive FS, and Group 3 will receive IT. All participants will receive a total of 24 hours of their assigned therapy over a period of 12 months. Study visits will occur at baseline, immediately post-intervention, and again six months and one year post-intervention. Weight change will be assessed, as well as changes in concerns about weight and shape. The cost-benefit ratio of the treatments will also be evaluated.

Eligibility criteria: Inclusion Criteria:

* Meets Diagnostic and Statistical Manual (4th Edition) (DSM-IV) criteria for anorexia nervosa

Exclusion Criteria:

* Any psychotic illness

Primary outcomes:
measure: Weight (BMI)
timeFrame: Measured at end-of-treatment and Months 6 and 12 post-treatment
Secondary outcomes:
measure: Changes in shape and weight concerns as measured with Eating Disorder Examination subscales
timeFrame: Measured at end-of-treatment and Months 6 and 12 post-treatment
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Daniel Le Grange, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00128986: Study of Tomotherapy in Patients With Benign Brain Tumour
Official title: A Phase I Study of Tomotherapy in Patients With Benign Brain Tumour
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Brain Neoplasms
Keywords: radiotherapy
brain
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2005-08-11
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Although malignant brain tumors are the most common type of primary brain tumor, there are a number of other benign brain tumors that exist. Many difficulties exist with treating these tumors that have led to controversies in the best treatment. A common issue among these brain tumors is the risk of long term side effects from treatment. What limits the use of curative radiation therapy is the ability to deliver a maximal dose to the tumor while minimizing the amount of radiation to the normal structures in the brain. A new method of delivering radiation, called tomotherapy, has been acquired at the Cross Cancer Institute (CCI) and will be used in this study. It has the ability to deliver a high dose of radiation to the tumor while minimizing the amount of radiation to normal brain structures. This study will use this method of radiation therapy to deliver radiation and see if the long term side effects from radiation therapy can be reduced.


Eligibility criteria: Inclusion Criteria:

* Histopathologically confirmed newly diagnosed base of skull benign tumour
* Karnofsky Performance Status (KPS) equal to or greater than 70

Exclusion Criteria:

* Brain metastases or recurrent tumour
* Prior radiotherapy (RT) to head or neck
* No prior chemotherapy or radiosensitizer

Primary outcomes:
measure: safety and adverse effects
timeFrame: Trial Completion
Secondary outcomes:
measure: efficacy and survival
timeFrame: Trial completion
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: AHS Cancer Control Alberta
name: Wilson Roa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00134186: Study of Motexafin Gadolinium for the Treatment of Renal Cell (Kidney) Cancer
Official title: Phase II Trial of Motexafin Gadolinium for Treatment of Metastatic Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Renal Cell
Urogenital Neoplasms
Urologic Neoplasms
Kidney Neoplasms
Keywords: Kidney cancer
Renal cell carcinoma
Motexafin gadolinium
Lead sponsor: Pharmacyclics LLC.
Sponsor class: INDUSTRY
First posted: 2005-08-24
Enrollment: 43
Sex: ALL
Minimum age (years): 18
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 find out if renal cell (kidney) cancer that has spread to other parts of the body will respond to treatment with motexafin gadolinium (MGd).


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years old
* Histologically confirmed renal cell carcinoma with clinically or pathologically confirmed progression
* Ineligible for interleukin-2 (IL-2) treatment and/or have had 2 or fewer prior treatments
* Measurable disease
* Hemoglobin ≥ 9 mg/dL
* ECOG performance status of 0, 1, or 2
* Willing and able to provide written informed consent

Exclusion Criteria:

* Inadequate bone marrow, renal and liver function by laboratory criteria

  * Absolute neutrophil count \< 1500/µL;
  * Platelet count \< 100,000/µL;
  * AST or ALT \> 2 x upper limit of normal (ULN);
  * Alkaline phosphatase \> 5 x ULN;
  * Total bilirubin \> 2 x ULN;
  * Creatinine \> 2.0 mg/dL.
* Evidence of central nervous system metastases within past year
* Uncontrolled hypertension
* Known history of porphyria, G6PD deficiency or HIV

Primary outcomes:
measure: Clinical response rate (CP, PR) to MGd in patients with confirmed progressive RCC (renal cell carcinoma)
Secondary outcomes:
measure: Clinical benefit rate (complete response [CR], partial response [PR], stable disease [SD])
measure: Time to progression
measure: Progression-free survival
measure: Overall survival and survival at 6 and 12 months
measure: Duration of clinical response
Other outcomes:
Locations:
city: Houston
country: United States
facility: Methodist Hospital
state: Texas
Study officials:
affiliation: Methodist Hospital Genitourinary Oncology
name: Robert J Amato, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02380586: Obstetric Anaesthesia And Analgesia Month Attributes - International
Official title: A National Survey on Obstetric Anesthesia and Analgesia Care - International
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstetric Anesthesia Care
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
Collaborators: name: Charles University, Czech Republic
name: Masaryk University
name: General University Hospital, Prague
name: Czech society of anesthesiology, resuscitation a intensive care - ČLS JEP
First posted: 2015-03-05
Enrollment: 3040
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women in labor

Brief summary: A national survey of current practices, preferred drug and technique choices for obstetric anesthesia and analgesia in Czech Republic and Slovak Republic.

Detailed description: A one month-long project monitoring an obstetric anesthesia practices in obstetric/anesthesia departments throughout the Czech Republic.

Electronic Case Report Form (eCRF) is used to collect data on all obstetric anesthesia procedures in peripartal period and obstetric and anesthesia complications. All consecutive cases in each participating center during the study period are recorded. Each record is related to parturient and contains the following sections: history, form of labour analgesia, type of anesthesia for Cesarean section and anesthesia in third stage of labor.

Eligibility criteria: Inclusion Criteria:

* Women in labor undergoing anesthesia care

Exclusion Criteria:

* not meeting inclusion criteria

Primary outcomes:
measure: A national survey of current practice of obstetric anesthesia and analgesia in Czech Republic and Slovak Republic
timeFrame: Parturition period, up to 24 hours after labor
Secondary outcomes:
measure: Types of anesthesia a analgesia in peripartal period
timeFrame: Parturition period, up to 24 hours after labor
Other outcomes:
measure: Complications related to obstetric anesthesia care
timeFrame: Parturition period, up to 24 hours after labor
Locations:
city: Brno
country: Czech Republic
facility: Faculty Hospital Brno
Study officials:
affiliation: FN Brno
name: Petr Štourač, MD, Ph.D
role: STUDY_CHAIR
References:
citation: Harazim H, Stourac P, Blaha J, Grochova M, Klozova R, Noskova P, Seidlova D, Richterova S, Svoboda M, Jarkovsky J, Silova X, Jezova B, Steinbach J, Zemanek M, Mannova J, Slavik J, Novakova Z, Misakova L, Firment J. The influence of mode of anaesthesia for caesarean delivery on neonatal Apgar scores in the Czech Republic and Slovakia: secondary analysis of the results of an international survey in 2015. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2019 Jun;163(2):147-154. doi: 10.5507/bp.2019.008. Epub 2019 Apr 9.
Clinical trial NCT01265186: Evaluation of Sedation in Newborns
Official title: Evaluation of Sedation in Newborns - a Prospective, Controlled, Observer Blinded Clinical Trial in 67 Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sedation
Keywords: Sedation
BIS
aEEG
Neonatal Pain and Sedation Scale
neonate
newborn
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2010-12-23
Enrollment: 67
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Ventilated term newborns with or without pharmacological sedation/analgesia

Brief summary: Neonates treated on Neonatal Intensive Care Units are often critically ill, subject to numerous painful procedures and often dependent on mechanical ventilation. Mechanical ventilation as well as painful conditions require a sufficient analgesia and or an accurately regulated sedation. Newborns incapable of self-report are therefore dependent on the assessment of the infants level of pain and sedation by the treating team.

The aim of this prospective, controlled, observer-blinded clinical trial is to compare the performance of two EEG based methods and a clinical sedation scale to measure the level of sedation in neonates. The Bispectral-Index (BIS) and the amplitude-integrated EEG (aEEG) are compared with the Neonatal Pain and Sedation Scale (N-PASS). We hypothesize a correlation between the clinical sedation score (N-PASS), the bispectral index (BIS) and the amplitude-integrated EEG (aEEG). Fifty-two mechanically ventilated term neonates and fifteen control patients are enrolled and observed for up to 72h.


Eligibility criteria: Inclusion Criteria:

* newborns with a corrected gestational age ≧ 37 and ≦ 44 weeks of gestation

Exclusion Criteria:

* congenital malformations
* chromosomal aberrations
* brain abnormalities
* severe cerebral hemorrhage (grade III-IV)
* cystic periventricular leukomalacia
* infections of the central nervous system

Primary outcomes:
measure: Correlation between clinical sedation score (N-PASS) and the bispectral index (BIS) and the amplitude-integrated EEG (aEEG)
timeFrame: 72 hours
Secondary outcomes:
measure: Differences of the values of the BIS, the aEEG and the sedation scores in the group of mechanically ventilated / sedated newborns and the group of non-ventilated /non-sedated neonates
timeFrame: 72 hours
measure: Relationship between daily doses of sedatives / analgesics and sedation levels
timeFrame: 72 hours
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Medical University of Vienna
Study officials:
References: