louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04499976: Isonicotinic Acid Hydrazide Pretreatment With Misoprostol Induction of Abortion in First-trimester Missed Miscarriage
Official title: Adjuvant Isonicotinic Acid Hydrazide (INH) With Misoprostol for Induction of Abortion in First-trimester Missed Miscarriage Among Women With One or More Previous Cesarean Deliveries.: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Abortion, Missed
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double blind randomized controlled study
Primary purpose: TREATMENT

Brief summary: This study compares the success rate of Adjuvant isonicotinic acid hydrazide and misoprostol versus misoprostol alone for medical termination of first-trimester pregnancy among women with one or more previous cesarean deliveries.

Detailed description: In the past, the role of laminaria and prostaglandins in cervical dilatation and reducing intraoperative complications of cervical dilatation have been proven . Misoprostol is a synthetic analogue of prostaglandin E1 used to treat and prevent gastric ulcers, which is now widely used in obstetrics and gynecology. Its applications in obstetrics and gynecology include medical abortion in the first and second trimesters of pregnancy.

Eligibility criteria: Inclusion Criteria:

* Gestational age less than 70 days gestation (\<10 wks).
* Hemoglobin \>10 g/dL.
* BMI between 18.5 kg/m2 and 30 kg/m2.
* Missed abortion
* previous one or more cesarean deliveries

Exclusion Criteria:

* Molar pregnancy
* Fibroid uterus.
* Uterine anomalies.
* Coagulopathy
* Medical disorder that contraindicate induction of abortion (e.g. heart failure).
* Previous attempts for induction of abortion in the current pregnancy.
* Allergy to misoprostol or INH.

Primary outcomes:
measure: induction to abortion time
timeFrame: 9 hours
measure: number of patient with complete abortion
timeFrame: 9 hours
Secondary outcomes:
measure: number of patient need for surgical evacuation of the products of conception
timeFrame: 12 hours
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University Hospital
Study officials:
affiliation: Aswan universirty
name: nahla w Shady
role: STUDY_CHAIR
References:
Clinical trial NCT03224676: Study to Assess the Quality of Sleep and Perceived Sleep Distractors Among the Adult Patients Admitted in Selected Hospital
Official title: Study to Assess the Quality of Sleep and Perceived Sleep Distractors Among the Adult Patients Admitted in Selected Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Sleep
Keywords: Quality of sleep
Perceived sleep distractors
Adult patients
Lead sponsor: Maharishi Markendeswar University (Deemed to be University)
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE

Brief summary: Aim of the study was to assess the quality of sleep among adult patients, to explore the perceived sleep distractors among adult patients, to determine the relationship between quality of sleep and perceived sleep distractors score among adult patients.

and to determine the association of quality of sleep and perceived sleep distractors score among adult patients with selected variables.

Detailed description: A total of 150 adult patients were selected from surgical, orthopedic and medical wards to participate in the study 50 patients from each ward. All the adult patients were selected using convenience sampling technique. Self-introduction and establishing rapport with the subjects was done. Purpose of the study was explained to the subjects, the confidentially of their responses was assured, and informed consent was taken prior to the study. The data was collected by Modified Pittsburgh Sleep Quality Index and Structured Perceived Sleep Distractors Performa.

Eligibility criteria: Inclusion Criteria:

The study includes adult patients who were:

* between age group of 18-65 years
* hospitalized minimum for 7 days.
* willing to participate in the study.
* present at the time of data collection.

Exclusion Criteria:Adult patients who were not:

* alert and oriented.

Primary outcomes:
measure: Quality of sleep
timeFrame: 20-25 min.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Maharishi Markandeshwar University
name: Preeti Sirohi, Msc.Nursing
role: PRINCIPAL_INVESTIGATOR
References:
citation: Levenson JC, Shensa A, Sidani JE, Colditz JB, Primack BA. The association between social media use and sleep disturbance among young adults. Prev Med. 2016 Apr;85:36-41. doi: 10.1016/j.ypmed.2016.01.001. Epub 2016 Jan 11.
citation: van Leeuwen WM, Lehto M, Karisola P, Lindholm H, Luukkonen R, Sallinen M, Harma M, Porkka-Heiskanen T, Alenius H. Sleep restriction increases the risk of developing cardiovascular diseases by augmenting proinflammatory responses through IL-17 and CRP. PLoS One. 2009;4(2):e4589. doi: 10.1371/journal.pone.0004589. Epub 2009 Feb 25.
citation: Shim J, Kang SW. Behavioral Factors Related to Sleep Quality and Duration in Adults. J Lifestyle Med. 2017 Jan;7(1):18-26. doi: 10.15280/jlm.2017.7.1.18. Epub 2017 Jan 31.
Clinical trial NCT05383027: Examining the Feasibility of Implementation, Patterns of Association, and Outcomes in HRV Biofeedback (HRVB) Intervention and Music Listening Control (MLC) on Alzheimer's Disease (AD) Family Caregivers (FCGs) Public Title: Caring Relationship Expression Study
Official title: Examining the Feasibility of Implementation, Patterns of Association, and Outcomes in HRV Biofeedback (HRVB) Intervention and Music Listening Control (MLC) on Alzheimer's Disease (AD) Family Caregivers (FCGs) Public Title: Caring Relationship Expression Study(CARES)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer's Disease and Related Dementias Family Caregivers
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In a remotely delivered nationwide pilot study, we will be examining a novel 8-week heart rate variability biofeedback (HRVB) intervention vs music listening control (MLC) for 30 family caregivers 18 years and older (FCGs) of Alzheimer's disease (AD) (and related dementias: ADRD) patients to examine feasibility (acceptability/adherence, satisfaction) and direction of change in caregiver burden, stress, resilience, anxiety, self-compassion, and relationship quality.


Eligibility criteria: Inclusion Criteria:

* 18 years and above
* primary, unpaid family caregiver for ADRD patient for 6 months or more
* owns and operates a smartphone with a data plan
* greater than of equal to 4 on caregiver burden scale

Exclusion Criteria:

* regular mind-body practice
* under 18 years old
* pacemaker
* conditions or medications that interfere with heart rate variability

Primary outcomes:
measure: Perceived Stress Scale-10
timeFrame: 13 weeks
measure: Zarit Burden Interview
timeFrame: 13 weeks
measure: Brief Resilience Scale
timeFrame: 13 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
References:
Clinical trial NCT02945527: Treatment of Peri-calcification Edema in Neurocysticercosis (NCC)
Official title: Open Controled Randomized Pilot Study on the Use of Acetazolamide and Dexamethasone for the Acute Phase of Perilesional Edema in Calcified Neurocysticercosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Neurocysticercosis
Lead sponsor: Universidad Peruana Cayetano Heredia
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Three-arm open, randomized comparative study of acetazolamide, dexamethasone, or no additional treatment to evaluate decrease in peri-calcification edema in neurocysticercosis

Detailed description: This study will evaluate 24 patients with calcified NCC and edema in three treatment arms to compare the reduction in edema volume

Eligibility criteria: Inclusion Criteria:

* Calcified NCC
* Perilesional edema on CT or MRI
* Normal lab values

Exclusion Criteria:

* Viable neurocysticercosis
* Status epilepticus
* Symptomatic intracranial hypertension
* Tuberculosis
* More than 7 days after seizure
* Pregnancy

Primary outcomes:
measure: Decrease in Volume of Perilesional Edema Between Baseline and Day 4
timeFrame: Baseline to Day 4
Secondary outcomes:
measure: Decrease in Volume of Perilesional Edema Between Baseline and Day 8
timeFrame: Baseline to Day 8
measure: Decrease in Volume of Perilesional Edema Between Baseline and Day 30
timeFrame: Baseline to Day 30
Other outcomes:
Locations:
city: Lima
country: Peru
facility: Cysticercosis Unit, Instituto Nacional de Ciencias Neurologicas
Study officials:
affiliation: Universidad Peruana Cayetano Heredia
name: Hector H. Garcia, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00851227: Study to Compare Conivaptan in Subjects With Mild & Moderate Liver Impairment Versus Subjects With Normal Liver Function
Official title: A Phase 1, Open-Label Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Intravenous Conivaptan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Liver Disease
Hyponatremia
Keywords: Pharmacokinetics
Protein Binding
Conivaptan
Vaprisol
Liver Disease
Lead sponsor: Cumberland Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-02-25
Enrollment: 26
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: A study to compare a 48-hour continuous infusion of conivaptan in subjects with mild and moderate liver impairment versus subjects with normal liver function


Eligibility criteria: Inclusion Criteria:

* Subjects with Normal Hepatic Function:

  * Weighs at least 45 kg
  * Body mass index between 18 and 40 kg/m2 inclusive
  * Must have normal hepatic function
* Hepatic Impaired Subjects:

  * Weighs at least 45 kg
  * Meets criteria for mild or moderate hepatic impairment defined by Child-Pugh method
  * Body mass index between 18 and 40 kg/m2 inclusive

Exclusion Criteria:

* Subjects with Normal Hepatic Function:

  * Smokes more than 10 cigarettes per day
  * Known to be HIV positive or has HIV antibodies
  * Has clinically significant history or presence of illness, malignancy, or immunodeficiency
  * Is Hepatitis A, B, or C positive
  * Has had a blood transfusion or donated/lost more than 550ml of blood within 8 weeks of study drug administration
  * History of substance abuse within 6 months prior to screening
* Hepatic Impaired Subjects:

  * Has history or presence of biliary obstruction or biliary disease, hepatic encephalopathy, advanced acidities, portal hypertension, or biliary liver cirrhosis
  * Is hypovolemic or has evidence of orthostatic hypotension
  * Smokes more than 10 cigarettes per day
  * Known to be HIV positive or has HIV antibodies
  * Has clinically significant history or presence of illness, malignancy, or immunodeficiency
  * Has clinically significant history or presence of GI symptoms other than those associated with moderate hepatic impairment
  * Has had a blood transfusion or donated/lost more than 550ml of blood within 8 weeks of study drug administration
  * History of substance abuse within 6 months prior to screening

Primary outcomes:
measure: Measure PK and protein binding of conivaptan
timeFrame: 5 days
Secondary outcomes:
measure: Measure tolerability of conivaptan
timeFrame: 5 days
Other outcomes:
Locations:
city: Miami
country: United States
state: Florida
Study officials:
affiliation: Cumberland Pharmaceuticals, Inc.
name: Art Wheeler, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04843527: Evaluation of Flash Continuous Glucose Monitoring to Reduce Hyperglycemia in People With T2 Diabetes
Official title: Evaluation of Flash Continuous Glucose Monitoring to Reduce Hyperglycemia in People
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Abbott Diabetes Care
Sponsor class: INDUSTRY
First posted: 2021-04-13
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A multi-center, randomized, prospective, non-significant risk study to compare the impact of the FreeStyle Libre Flash Glucose Monitoring System with and without a food logging smartphone application on reducing time above 180 mg/dL in subjects with type 2 diabetes who are not adequately controlled on their existing oral anti-diabetes medication regimen.

Detailed description: Approximately 350 subjects will be enrolled to obtain at least 84 randomized subjects,approximately 42 subjects per arm. Subjects will be randomized to use either the FreeStyle Libre Flash Glucose Monitoring System or FreeStyle Libre Flash Glucose Monitoring System with a food logging smartphone application to manage their diabetes.

The subsequent impact on reducing the amount of time spent above 180 mg/dL will be assessed.

Eligibility criteria: Inclusion Criteria:

* Subject must be at least 18 years of age.
* Subject has been diagnosed with type 2 diabetes.
* HbA1c greater than or equal to 7.5% and less than or equal to 12%
* Subject is on at least 1 diabetes medication in the classes of metformin, SGLT-2 inhibitors, GLP-1 agonists and DPP-4 inhibitors.
* Subject owns a compatible smartphone
* Subject agrees to a 3-month period of no diabetes medication changes.
* Subject is willing to make diet and lifestyle changes in response to education and glucose data

Exclusion Criteria:

* Subject is currently on insulin therapy or sulfonylurea-based medications.
* Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
* Subject is known to be pregnant at the time of study enrollment (applicable to female subjects only).
* Subject has extensive skin changes/diseases at the proposed application sites that could interfere with device placement or the accuracy of interstitial glucose measurements.

Primary outcomes:
measure: Impact on time above 180 mg/dL
timeFrame: Three (3) months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Minneapolis
country: United States
facility: HealthPartners Institute dba International Diabetes Center
state: Minnesota
city: Pittsburgh
country: United States
facility: UMPC
state: Pennsylvania
Study officials:
affiliation: Abbott Diabetes Care Inc
name: Shridhara A Karinka, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06670027: The Effects of Use of Auditory Stimulation Methods on Cardiac Patients' Clinical Outcomes
Official title: The Effects of Using Auditory Stimulation Methods on Cardiac Patients' Clinical Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chest Pain
Anxiety
Sleep
Lead sponsor: Damanhour University
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Group A will receive a family voice message and Group B will be received nature sound
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will be used to compare the effects of two auditory stimulation methods on improving vital signs parameters, reducing the severity of chest pain, and improving the sleep quality of cardiac patients.

Detailed description: This study aims to To evaluate the relative efficacy of two auditory stimulation techniques in enhancing cardiac patients' vital sign assessments.

* This study aims to examine two auditory stimulations for their ability to alleviate chest pain in patients with heart conditions.
* The goal of this study is to evaluate two audio stimulations for their potential to help heart patients have a better night's rest.

This research made use of two different therapies including audio stimulation. Group A used familiar auditory stimulus, which was a spoken message, and group B used sounds of nature.

Patients with preexisting cardiac conditions who were admitted to a predetermined critical care unit and who subsequently intended to have percutaneous coronary artery intervention (PCI)

Eligibility criteria: Inclusion Criteria:

* adult (aged≥18 years).
* diagnosed with cardiac disease.
* patient with hemodynamic stability
* consciousness and ability to communicate.

Exclusion Criteria:

* patients unable to comply with study interventions
* patients with cognitive impairment
* patients with severe unstable cardiac condition
* having a history of hearing loss or the use of a hearing aid.

Primary outcomes:
measure: sleep quality
timeFrame: three days after intervention
measure: severity of chest pain
timeFrame: three days after intervention
measure: level of anxiety and depression
timeFrame: three days after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Damanhūr
country: Egypt
facility: Faculty of nursing Damanhour university
Study officials:
References:
Clinical trial NCT01217827: Implantable Cardioverter-Defibrillator Use in the VA System
Official title: Implantable Cardioverter-Defibrillator (ICD) Utilization in a Potentially Eligible VA Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiomyopathies
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Medtronic
name: VA Palo Alto Health Care System
First posted: 2010-10-08
Enrollment: 89
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: Despite being a proven life-saving intervention in appropriately selected individuals, multiple studies continue to demonstrate low implantation of defibrillators in potential candidates. Based upon prior research, a major barrier to low utilization is low referral of potential candidates by healthcare providers. In this study, via brief clinical reminder placed in the electronic medical record, we ask healthcare providers who have not referred potential candidates for defibrillator the reasons for this decision and provide them with the tools for referral if appropriate.


Eligibility criteria: Inclusion Criteria:Meeting published criteria for receipt of an implantable cardioverter defibrillator Exclusion Criteria:provider is not affiliated with the VA health care system

Primary outcomes:
measure: Referral for Implantable Cardioverter Defibrillator
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Paul A. Heidenreich
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gupta A, Gholami P, Turakhia MP, Friday K, Heidenreich PA. Clinical reminders to providers of patients with reduced left ventricular ejection fraction increase defibrillator referral: a randomized trial. Circ Heart Fail. 2014 Jan;7(1):140-5. doi: 10.1161/CIRCHEARTFAILURE.113.000753. Epub 2013 Dec 6.
Clinical trial NCT01338727: Breastfeeding Education and Support Trial for Obese Women (BESTOW)
Official title: Breastfeeding Education and Support Trial for Obese Women (BESTOW)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exclusive Breastfeeding
Breastfeeding Initiation
Lead sponsor: University of Connecticut
Sponsor class: OTHER
First posted: 2011-04-19
Enrollment: 206
Sex: FEMALE
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: The primary objective of this study is to evaluate the efficacy of a specialized exclusive breastfeeding education and support program targeting obese, pregnant, low-income women in Hartford, CT. Specifically, the investigators will evaluate the impact of the intervention on exclusive and partial breastfeeding rates at birth, 1, 3 and 6 months pp. Secondary aims of this study are: a) to characterize postpartum weight loss patterns and blood pressure values of obese women, by study group; and b) to evaluate potential differences in infant morbidity (diarrhea, otitis media and rehospitalization), by study group.


Eligibility criteria: Inclusion Criteria:

* obese (prepregnant BMI 27.0 or greater)
* pregnant women delivering at Hartford Hospital
* no more than 34 weeks gestation
* considering breastfeeding this child
* low income (\<185% Federal poverty level)
* planning to remain in the greater Hartford area for 6 months postpartum
* must have access to a telephone for follow-up interviews
* delivery of a healthy, term, singleton

Exclusion Criteria:

* HIV positive or having other conditions which interfere with exclusive breastfeeding
* Infant admitted to the Neonatal Intensive Care Unit

Primary outcomes:
measure: Exclusive Breastfeeding Rate
timeFrame: 3 months postpartum
Secondary outcomes:
measure: Breastfeeding Rate
timeFrame: 3 months postpartum
measure: Breastfeeding Initiation Rate
timeFrame: For the duration of the hospital stay, average equals 3 days
Other outcomes:
Locations:
city: Storrs
country: United States
facility: University of Connecticut
state: Connecticut
Study officials:
affiliation: University of Connecticut
name: Rafael Pérez-Escamilla, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chapman DJ, Morel K, Bermudez-Millan A, Young S, Damio G, Perez-Escamilla R. Breastfeeding education and support trial for overweight and obese women: a randomized trial. Pediatrics. 2013 Jan;131(1):e162-70. doi: 10.1542/peds.2012-0688. Epub 2012 Dec 3.