louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05492890: Continuous Glucose Monitoring for Women With Diabetes Mellitus in the Intrapartum and Postpartum Inpatient Care
Official title: The Use of Continuous Glucose Monitors in the Intrapartum and Postpartum Inpatient Care of Women With Diabetes Mellitus: A Randomized Noninferiority
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes, Gestational
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women ages 18-45 who are pregnant

Brief summary: Diabetes mellitus affects roughly 8% of pregnancies and is associated with significant perinatal and maternal morbidity. Increasing numbers of women are either entering pregnancy with a continuous glucose monitor (CGM) or are initiating use during pregnancy, with data emerging suggesting improved outcomes among those using CGM. Since the introduction of CGM in the late 1990s, there has been slow acceptance of their validation and use in the inpatient setting. The investigators propose an observational prospective cohort study to analyze the correlation of CGM data with traditional capillary glucose readings in the intrapartum and postpartum settings.


Eligibility criteria: Inclusion Criteria:

* Age 18-50 years
* Women with a viable singleton or twin intrauterine pregnancy between 22 5/7 and 41 6/7 weeks gestation based on the best obstetric estimate by ACOG criteria
* Diagnosis of insulin-dependent pregestational diabetes mellitus (type 1 or type 2 diabetes)
* Planning to deliver at OSU Wexner Medical Center
* Able to understand the study, and having understood, provide written informed consent in English

Exclusion Criteria:

* Gestational diabetes mellitus, Maturity Onset Diabetes of Young, and Cystic Fibrosis Related Diabetes
* Abnormal obstetrical ultrasound suspicious for major congenital abnormality
* Known or suspected fetal aneuploidy (by either CVS, amniocentesis, or cell-free DNA)
* Participation in another trial that may influence the primary outcome, without prior approval
* Participation in this trial in a prior pregnancy
* Higher order pregnancy
* History of severe skin allergy to adhesive products or CGM within the previous 3 months

Primary outcomes:
measure: Maternal outcome
timeFrame: 9 months
Secondary outcomes:
measure: Neonatal outcomes
timeFrame: 10 days
Other outcomes:
Locations:
Study officials:
affiliation: tOSU Medical Center
name: Elizabeth Buschur, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05023590: Atrial Fibrillation Registry 2017
Official title: Monocentric, Randomized, Prospective Study to Compare Endocardiac Radio Frequency Ablation and Cryo Ablation of the Left Atrium During an Open Chest Mitral Valve Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Mitral Valve Failure
Keywords: sinus rhythm
atrial fibrillation
Lead sponsor: Herz- und Gefaesszentrum Bad Bevensen
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: monocentric, 1:1 randomized (cryo ablation vs. radiofrequency ablation), open-label, parallel, registry
Primary purpose: TREATMENT

Brief summary: Monocentric, prospective, randomized trial of cardiac surgical arrhythmia using endocardial radiofrequency atrial ablation compared with a cryo ablation system in the setting of cardiac surgery.

Detailed description: Regular, rhythmic monitoring (24-hour Holter ECG, 5 and 28 days, 3 and 6 months po) of patients after cardiac surgery on the mitral valve with atrial ablation for paroxysmal, persistent, and permanent atrial fibrillation with regard to the presence or stability of sinus rhythm.

Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years
* Present, written informed consent from the patient
* paroxysmal, persistent, or permanent atrial fibrillation not longer than 10 years according to guidelines (ACC, AHA, ESC)
* planned cardiac surgery on the mitral valve
* ECHO parameters : LA size a.p. ≤ 55mm

Exclusion Criteria:

* permanent atrial fibrillation longer than 10 years
* ECHO parameters : LA size a.p. \> 55mm
* pregnancy
* life expectancy \< 12 months
* lack of cognitive or mental capacity to participate in the study
* Patients who are to be included in another clinical (interventional) study at the same time or who are already participating in such a study

Primary outcomes:
measure: number of patients with stabil sinus rhythm 6 month after ablation
timeFrame: 6 month after index surgery / ablation
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Bevensen
country: Germany
facility: Herz- und Gefaesszentrum Bad Bevensen
state: Lower Saxony
Study officials:
affiliation: Herz- und Gefäßzentrum Bad Bevensen
name: Gerhard Wimmer-Greinecker, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04320290: HCV + to HCV - Kidney Transplant
Official title: Hepatitis C Viral Kidneys Used for Non-Viremic Recipients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Kidney Failure
Hepatitis C
Keywords: Kidney Transplant
Kidney Failure
HCV
Hepatitis C
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a single center study characterizing the experience of administration of 8 weeks of pan-genotypic DAA therapy in kidney transplantation to prevent the transmission of hepatitis C virus infection from an HCV-positive donor kidney to an HCV-negative recipient.

Detailed description: The goal of this study is to determine if 8 weeks of preemptive and sustained administration of pan-genotypic DAA therapy after kidney transplant prevents the transmission of hepatitis C virus (HCV) infection from an HCV-positive donor kidney to an HCV-naive recipient.

Eligibility criteria: Recipient Inclusion Criteria:

* Met MGH transplant center criteria and already listed for kidney transplant
* Must agree to birth control. Women must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Strategy and at least one barrier method
* No evidence of clinically significant liver disease at the time of transplant readiness as determined by the clinical team
* Able to sign informed consent

Recipient Exclusion Criteria:

* Pregnant or nursing (lactating) women
* HBV positivity (Ag or DNA)
* Any contra-indication to kidney transplantation per center protocol

Donor Inclusion Criteria

* Detectable HCV NAT test
* KDPI score is less than ≤ 0.850
* Traditional Donor Selection Criteria Met - acceptable for transplantation per usual evaluation

Donor Exclusion Criteria

* Confirmed HIV
* Confirmed HBV positive (surface antigen or HBV DNA positive)
* Any standard contra-indication to donation noted in donor (significant malignancy, unusual infection, kidney anatomical damage or significant pathology)

Primary outcomes:
measure: Undetectable HCV RNA
timeFrame: 12 weeks post-treatment
measure: Rate of Serious and non-serious adverse events
timeFrame: 1 year post-transplant
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02021890: Efficacy Study of Standard Ballroom and Latin Dance Program in Type 2 Diabetes and Obesity
Official title: A Standard Ballroom and Latin Dance Program to Improve Fitness and Adherence to Physical Activity in Individuals With Type 2 Diabetes and Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Obesity
Keywords: Dance
Physical activity
Physical fitness
Weight loss
Lead sponsor: University of Bologna
Sponsor class: OTHER
Collaborators: name: General Hospital, Gavardo
name: Villa Garda Hospital
First posted: 2013-12-27
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: to test the metabolic and clinical effects of a 6-month program of dancing in subjects with type 2 diabetes and/or obesity, chronically cared for in two diabetes/metabolic units. Self-selection of the leisure time activity program was allowed to increase adherence to the physical activity programs.


Eligibility criteria: Inclusion Criteria:

* type 2 diabetes in fairly good metabolic control (glycosylated hemoglobin (HbA1c) \< 8.5%) and/or obesity (Body Mass Index (BMI) ≥ 30 kg/m2 or waist circumference \>94 cm in males, \>80 in females), with/without prediabetes or minor alterations of HbA1c.

Exclusion Criteria:

* previous cardiovascular events, muscle-skeletal problems reducing physical ability, any general condition limiting systematic adherence

Primary outcomes:
measure: 5% reduction in BMI or waist circumference
timeFrame: 3 months
measure: 5% reduction in BMI or waist circumference
timeFrame: 6 months
measure: improved physical fitness (physical activity exceeding 10 MET-hour/week
timeFrame: 3 months
measure: improved physical fitness (physical activity exceeding 10 MET-hour/week
timeFrame: 6 months
Secondary outcomes:
measure: 0.3% reduction of HbA1c in the presence of diabetes
timeFrame: 3 months
measure: 0.3% reduction of HbA1c in the presence of diabetes
timeFrame: 6 months
measure: 10% increase in 6-min walk test
timeFrame: 3 months
measure: 10% increase in 6-min walk test
timeFrame: 6 months
Other outcomes:
Locations:
city: Gavardo
country: Italy
facility: Unit of Endocrinology and Diabetology, General Hospital
state: Brescia
city: Bologna
country: Italy
facility: Unit of Metabolic Diseases and Clinical Dietetics, "Alma Mater Studiorum" University
Study officials:
References:
citation: Mangeri F, Montesi L, Forlani G, Dalle Grave R, Marchesini G. A standard ballroom and Latin dance program to improve fitness and adherence to physical activity in individuals with type 2 diabetes and in obesity. Diabetol Metab Syndr. 2014 Jun 22;6:74. doi: 10.1186/1758-5996-6-74. eCollection 2014.
Clinical trial NCT00273390: A Clinical Trial of Infliximab for Uveitis
Official title: The Use of Remicade (Infliximab) in the Management of Vision-threatening Uveitis That is Refractory to Other Modes of Systemic Immunosuppression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uveitis
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Centocor, Inc.
First posted: 2006-01-09
Enrollment: 32
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This project is designed to test the hypothesis that inhibition of binding between tumor necrosis factor alpha (TNF-alpha) and its receptors using Remicade (infliximab, chimeric mouse/human IgG1K monoclonal antibody directed against human TNF-alpha, Centocor, Malvern,PA) is clinically useful for patients with uveitis that is refractory to other forms of systemic immunosuppressive therapy.


Eligibility criteria: Inclusion Criteria:

1. The study group will include patients suffering from treatment-resistant vision-threatening uveitis who attend the Uveitis Clinic at Casey Eye Institute.
2. We plan to enroll 32 patients.

Exclusion Criteria:

1. Patients with ocular or systemic infection.
2. Patients with the subtype of uveitis termed pars planitis who have MRI scan evidence of demyelination. There is a theoretical risk of adverse outcome of TNF-alpha inhibition on the clinical course of multiple sclerosis. Patients who suffer from pars planitis are at increased risk of developing multiple sclerosis.
3. Children under the age of 9.
4. Patients with known sensitivity to mouse proteins. Remicade is a chimeric protein with human and murine components.
5. Patients with history of cancer (exception- skin cancers which are curatively resected), organ transplantation (exception- cornea), recent drug or alcohol addiction, or inability to keep appointments.
6. Patients with other serious systemic diseases that could interfere with participation in the study.
7. It is specifically noted that pregnant women and nursing mothers will be excluded from this study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Oregon Health and Science University
name: James T Rosenbaum, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Eric B Suhler, MD
role: STUDY_DIRECTOR
affiliation: Oregon Health and Science University
name: Justine Smith, MBBS, Phd
role: STUDY_DIRECTOR
References:
citation: Suhler EB, Smith JR, Wertheim MS, Lauer AK, Kurz DE, Pickard TD, Rosenbaum JT. A prospective trial of infliximab therapy for refractory uveitis: preliminary safety and efficacy outcomes. Arch Ophthalmol. 2005 Jul;123(7):903-12. doi: 10.1001/archopht.123.7.903.
citation: Suhler EB, Smith JR, Giles TR, Lauer AK, Wertheim MS, Kurz DE, Kurz PA, Lim L, Mackensen F, Pickard TD, Rosenbaum JT. Infliximab therapy for refractory uveitis: 2-year results of a prospective trial. Arch Ophthalmol. 2009 Jun;127(6):819-22. doi: 10.1001/archophthalmol.2009.141. No abstract available.
Clinical trial NCT00000290: Stress Hormones and Human Cocaine Use - 7
Official title: Stress Hormones and Human Cocaine Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cocaine-Related Disorders
Keywords: cocaine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: University of Minnesota
First posted: 1999-09-21
Enrollment: 0
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the HPA axis and adrenergic system activation in response to cocaine administration.

Detailed description: The goal of this study was to investigate the role of sympathetic-adrenal medullary (SAM) and hy0pothalamo-pituitary-adrenal (HPA) systems in mediating the addictive effects of cocaine. A toal of 6 male subjects were enrolled for this 5 day inpatient study. Subjects were assigned to either cocaine (32mg /70kg iv) or placebo (saline iv) treatment during the first experimental sessions and were crossed over to the alternative treatment during the second experimental session. Endpoints that were followed during the experimental sessions included neuroendocrine (serum epinephrine, norepinephrine and cortisol levels), physological (heart rate/blood pressure, EKG) and subjective measures (Beck Depression Inventory, Craving Questionnaire). We hypothesized that cocaine administration would lead to increased blood levels of norpinephrine, epinephrine and cortisol in cocaine dependent subjects.

Eligibility criteria: Inclusion Criteria:

Males between the ages of 20-45. History of smoked or intravenous cocaine use on the average of at least once a week over a 6 month period. Current history of good health and normal EKG.

Exclusion Criteria:

History of suicide attempt, bipolar disorder, schizophrenia, or generalized anxiety disorder. Current problem with major depressive disorder. Current use of alcohol or other drugs on a daily basis. History of major medical illnesses. Currently on parole, probation or a legal history of violence. Treatment for chemical dependency within the past 6 months. History of sensitivity to tricyclic compounds or other prescription drugs. Use of any psychotropic drugs including MAOIs in the past 6 months.

Primary outcomes:
measure: Physiological measures
measure: Biochemical
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Dorothy Hatsukami, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Presented at CPDD, 6/13/99. None
Clinical trial NCT00695890: Effects of Sevoflurane and Propofol on Light Flash Evoked Pupillometry
Official title: Effects of Sevoflurane and Propofol on Light Flash Evoked Pupillometry.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Measurement of Pupil Diameter
Keywords: Pupillometry
Sevoflorane
Propofol
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2008-06-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: Null hypothesis (HO): There will be no difference in pupillometry readings when using any of the maintenance anesthetic techniques within subjects.

Alternate hypothesis (HA): Pupillometry readings will be affected by a change in the anesthetic technique

Detailed description: Postoperative visual loss resulting from a surgical procedure not performed on the eye is a devastating outcome for the patient and poorly understood by the medical community. It is potentially a preventable complication. Diminished blood supply to the optic nerve, affecting both the anterior or posterior portions of the optic nerve, is the most common cause of postoperative visual loss. Other, less common causes include occlusion of the retinal artery and vein, a retinal embolism and cortical blindness. The incidence of postoperative visual loss increases in patients undergoing cardiopulmonary bypass and prone spine surgery. Although the etiology of post-operative visual loss is unknown, it is thought to be multifactorial, and several potential risk factors have been identified, including degree of low blood pressure, preoperative hematocrit, external compression of the eye, amount of blood loss, prolonged duration of surgical time and increased pressure in the eye associated with positioning. To date studies have focused on the mechanism associated with the visual loss. We would like to focus on the feasibility of using a monitor which may signal loss of visual function intraoperatively.

Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 18 and 70 years of age who are mentally capable of providing an informed consent and who are medically classified as ASA 1 or 2.
* Planned elective orthopedic extremity surgery in the supine position with the head in the neutral position.

Exclusion Criteria:

* Failure to provide an informed consent
* Known history of eye disease which cannot be corrected with lenses
* Surgery lasting less than 45 minutes

Primary outcomes:
measure: We would like to focus on the feasibility of using a monitor which may signal loss of visual function intraoperatively.
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: UMDNJ
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Geordie Grant, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01925690: Development of a Motivational Intervention to Improve Treatment Adherence in MS
Official title: Development of a Motivational Intervention to Improve Treatment Adherence in MS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Relapsing-remitting Multiple Sclerosis
Keywords: Multiple Sclerosis
Disease modifying medication
Relapsing-Remitting MS
Motivational Interviewing
Telephone Counseling
Lead sponsor: University of Missouri, Kansas City
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
First posted: 2013-08-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: As many as 50% of MS patients prematurely discontinue their disease modifying medications. For this study, we will develop a telephone-based talk therapy intervention and then conduct a randomized controlled trial. Patients will be assigned to either 5 weekly 20 minute telephone sessions of psychotherapy or a brief education control condition. We hypothesize that patients undergoing phone therapy will be more likely to indicate they are interested in resuming taking disease modifying medications than patients given brief education and treatment as usual.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of relapsing remitting MS based on established guidelines
* Previously discontinued recommended therapy
* Provider recommendation for DMT re-initiation
* At least 18 years of age
* Access to a telephone
* English speaking

Exclusion Criteria:

* Diagnosis other than relapsing remitting MS
* Provider does not recommend DMT re-initiation
* Pregnant or breastfeeding (females)

Primary outcomes:
measure: Adherence Treatment Survey
timeFrame: 10 weeks after enrollment
Secondary outcomes:
measure: Adherence Treatment Survey
timeFrame: 10 weeks after enrollment
measure: Adherence Treatment Survey
timeFrame: 5 weeks after enrollment
measure: Adherence Treatment Survey
timeFrame: 5 weeks after enrollment
Other outcomes:
measure: Motivation/Readiness Questionnaire
timeFrame: 10 weeks post-enrollment
measure: Motivation/Readiness Questionnaire
timeFrame: 5 weeks post-enrollment
Locations:
city: Kansas City
country: United States
facility: University of Missouri-Kansas City
state: Missouri
city: West Orange
country: United States
facility: Kessler Rehabillitation Institute
state: New Jersey
Study officials:
affiliation: University of Missouri, Kansas City
name: Jared M Bruce, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bruce J, Bruce A, Lynch S, Strober L, O'Bryan S, Sobotka D, Thelen J, Ness A, Glusman M, Goggin K, Bradley-Ewing A, Catley D. A pilot study to improve adherence among MS patients who discontinue treatment against medical advice. J Behav Med. 2016 Apr;39(2):276-87. doi: 10.1007/s10865-015-9694-6. Epub 2015 Nov 12.