louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00507546: Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia
Official title: Melatonin Replacement for Treatment of Sleep Disruption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Insomnia
Spinal Cord Injury
Tetraplegia
Sleep Disorders
Keywords: sleep
melatonin
spinal cord injury
insomnia
tetraplegia
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Stanford University
name: Takeda
First posted: 2007-07-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if replacing melatonin function with a melatonin agonist (ramelteon) in individuals that lack endogenous melatonin production (tetraplegia) helps to alleviate self-reported sleep disruption.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older, male or female veterans of any racial or ethnic group
* Neurologically complete (Frankel A or B) damage to the lower (C4-C8) cervical spinal cord
* Absence of melatonin production
* Time since SCI is greater than 6 months \[no cases of acute spinal cord injury\]
* Subjective complaint of sleep disruption

Exclusion Criteria:

* Current use of fluvoxamine (Luvox , antidepressant), rifampin (antimycobacterial), ketoconazole (Nizoral , antifungal), or fluconazole (Diflucan , antifungal) \[these interact with the same liver enzyme that is the primary metabolizer of ramelteon\]; use of sleep medications is okay
* Hepatic dysfunction
* Concomitant use of over-the-counter melatonin
* Pregnancy or breast feeding
* Currently or have within the past six months met DSM-IV (Diagnosis and Statistical Manual IV) criteria for drug or alcohol abuse or dependence or AUDIT score \>19
* Acute illness or unstable chronic illness. Use of continuous positive airway pressure (CPAP) for treatment of sleep apnea is acceptable.
* No travel across three or more time zones within three weeks or during the protocol
* Illiterate or unable to read or write English or are judged by the investigator to be unable or unlikely to follow the study protocol

Primary outcomes:
measure: Amount of Wakefulness After Sleep Onset (WASO)
timeFrame: 10 weeks
Secondary outcomes:
measure: Change in Subjective Morning Alertness
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
Study officials:
affiliation: VA Palo Alto Health Care System
name: Jamie M. Zeitzer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zeitzer JM, Ku B, Ota D, Kiratli BJ. Randomized controlled trial of pharmacological replacement of melatonin for sleep disruption in individuals with tetraplegia. J Spinal Cord Med. 2014 Jan;37(1):46-53. doi: 10.1179/2045772313Y.0000000099. Epub 2013 Oct 24.
Clinical trial NCT01609946: Realtime-Elastography (RTE) and Thyroid Nodules
Official title: Evaluation of Realtime-Elastography for Differentiation of Thyroid Nodules: a Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Nodules
Keywords: presenting for FNAB or surgery
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2012-06-01
Enrollment: 602
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study is an open, prospective multicenter study. According to the statistical sample size calculation 593 patients with thyroid nodules ≥ 5mm in size will be included in the study. Reference methods are cytology obtained by Fine needle aspiration biopsy (FNAB) or histology obtained by surgery.

All patients will receive an B-mode and Duplex ultrasound examination of the thyroid gland, as well as Realtime Elastography of thyroid nodules.

Results of B-mode and Duplex ultrasound are compared to Realtime Elastography to evaluate the additional value of Realtime Elastography in the diagnostic work up of thyroid nodules.


Eligibility criteria: Inclusion Criteria:

* patients with thyroid nodules ≥ 5mm in size and TSH ≥ 0,35µU/ml
* Cytology obtained by FNAB or thyroid surgery planned
* age ≥ 18 year
* signed written consent

Exclusion Criteria:

* Diseases which preclude study accomplishment or put the patient at any risk (e.g. psychiatric diseases)
* Non-contractually capable persons
* Pregnancy
* Lactation

Primary outcomes:
measure: Realtime-Elastography scores I-IV in thyroid nodules
Secondary outcomes:
measure: Comparison of Realtime-Elastography with B-mode and Duplex-Ultrasonography concerning the additional diagnostic information obtained by Realtime-Elastography
Other outcomes:
Locations:
city: Bad Mergentheim
country: Germany
facility: Caritas-Krankenhaus
city: Bielefeld
country: Germany
facility: Klinikum Bielefeld
city: Frankfurt am Main
country: Germany
facility: Klinikum der J. W. Goethe-Universität
city: Frankfurt
country: Germany
facility: Bürgerhospital
city: Geislingen
country: Germany
facility: Helfenstein Klinik
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Reutlingen
country: Germany
facility: Klinikum am Steinberg
city: Stuttgart
country: Germany
facility: Endokrinologie und Diabetologie im Zentrum
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Wiesbaden
country: Germany
facility: Deutsche Klinik für Diagnostik
Study officials:
affiliation: Klinikum der J. W. Goethe-Universität, Frankfurt, Germany
name: Joerg Bojunga, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005446: Endogenous Estrogen and Coronary Heart Disease in Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Coronary Disease
Heart Diseases
Myocardial Infarction
Postmenopause
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2000-05-26
Sex: FEMALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE

Brief summary: To investigate the relation between endogenous levels of estrogen in postmenopausal women and the subsequent development of coronary heart disease.

Detailed description: BACKGROUND:

Studies suggest that estrogen replacement therapy (ERT) lowers the risk of coronary heart disease in postmenopausal women. However, it is not known whether higher endogenous levels of estrogens in the postmenopausal period likewise have a protective effect.

DESIGN NARRATIVE:

The study used an existing resource of frozen blood samples from a cohort of 7,058 postmenopausal women enrolled between 1985 and 1991 for a study of endogenous hormones and cancer. The cohort was followed up to identify incident cases of coronary heart disease. One hundred thirty cases of coronary heart disease (defined as nonfatal myocardial infarction or death from coronary heart disease) were expected to occur by the end of follow-up. A nested case-control study was conducted in which each case was matched to two women from the cohort who were the same age as the case, donated blood around the same time, and were alive and free of heart disease as of the date of diagnosis of the case. Frozen serum samples from cases and their matched controls were analyzed for total estradiol, bioavailable estradiol (the estradiol fraction not bound to sex hormone binding globulin) estrone, total cholesterol, and high- and low-density lipoprotein cholesterol. Conditional logistic regression for matched sets were employed to determine whether estrogen levels were lower in the cases than their matched controls. The association between estrogen levels and cholesterol fractions was also investigated.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02577146: The Predictive Value of Ureteral Jet Assessment With Ultrasound in Patients Presenting With Acute Renal Colic
Official title: The Predictive Value of Ureteral Jet Assessment With Ultrasound in Patients Presenting With Acute Renal Colic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ureteral Calculi
Keywords: stone
ureter
ultrasound
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Midwest Stone Institute.
First posted: 2015-10-16
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a single institution, prospective study to evaluate the prognostic significance of renal and bladder ultrasound with ureteral jet assessment and its utility to evaluate the spontaneous stone passage rate of ureteral stones.


Eligibility criteria: Inclusion Criteria:

* age 18 and older at the time of consent
* willing and able to sign consent
* CT diagnosis of ureteral stone with a stone burden less than or equal to 10mm

Exclusion Criteria:

* obstructed solitary kidney
* obstructed transplant kidney
* bilateral obstructed kidneys
* any condition or reason that, in the opinion of the treating physician, interferes with the patient's ability to participate or places the patient at undue risk.

Primary outcomes:
measure: Time in Days From Diagnosis to Stone Passage.
timeFrame: 42 days
Secondary outcomes:
measure: The Number of Cases With Concordant Treatment Recommendations Based on the Ultrasound and CT Scan.
timeFrame: 42 days
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Alana Desai, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00655746: The Effect of Omeprazole on the Pharmacokinetics of Dasatinib in Healthy Subjects
Official title: The Effect of Omeprazole on the Pharmacokinetics of Dasatinib (BMS-354825) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Subjects
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2008-04-10
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to assess the effect of omeprazole on the pharmacokinetics of dasatinib in healthy subjects and to assess the safety and tolerability of a single dose of dasatinib before and after 5 days of dosing with omeprazole in healthy subjects


Eligibility criteria: Inclusion Criteria:

* Healthy subjects as determined by medical history, physical examination, ECGs, and clinical laboratory determinations

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Prior exposure to dasatinib

Primary outcomes:
measure: Dasatinib Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose
measure: Dasatinib PK Parameter Time of Maximum Observed Plasma Concentration(Tmax)
timeFrame: Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose
measure: Dasatinib PK Parameter: Plasma Half-Life (T-HALF)
timeFrame: Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose
measure: Dasatinib PK Parameter: Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-T])
timeFrame: Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose
measure: Dasatinib PK Parameters: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF])
timeFrame: Day 1 and Day 6 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours post dose
Secondary outcomes:
measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations
timeFrame: At Informed Consent (within 21 days of Day 1) through Study Discharge (Day 7)
Other outcomes:
Locations:
city: Hamilton
country: United States
facility: Bristol-Myers Squibb Clinical Pharmacology Unit
state: New Jersey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT06427746: Enhancing Prehospital Stroke Diagnosis
Official title: Accuracy and Implementation of Diagnostic Ability in Stroke in the Pre-Hospital Setting
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Keywords: stroke
video call
Lead sponsor: Agenzia Regionale emergenza Urgenza
Sponsor class: OTHER_GOV
First posted: 2024-05-24
Enrollment: 2197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients in the prehospital setting with suspected ischemic stroke rescued by the emergency medical service in the Milan metropolitan area

Brief summary: Current American Heart Association Guidelines recommend that stroke patients be promptly rescued and identified so that the accepting hospital can be alerted and prepared to receive and treat them promptly. It is also recommend that stroke identification be performed using validated and standardized assessment scales. This study aims to analyze the possibility to increase the correct identification of stroke patients after implementation of several new operative procedures by the emergency medical service (EMS) of the metropolitan area of Milan (SOREU). The interventions adopted include:

1. the evaluation of patients with suspected stroke via video call between the lay rescue personnel and the dispatch healthcare personnel
2. the training of lay rescue personnel, operating in the metropolitan area, aimed at implementing the application of the Cincinnati Prehospital Stroke Scale (CPSS) scale and to expand the neurological examination with the addiction of the Large ARtery Intracranial Occlusion Stroke Scale (LARIO) in the clinical evaluation.


Eligibility criteria: Inclusion Criteria:

* suspected stroke
* rescued by basic life support vehicle
* consciousness
* informed consent

Exclusion Criteria:

* age \< 18 years
* rescued by an advanced life support vehicle

Primary outcomes:
measure: Accuracy of prehospital stroke diagnosis
timeFrame: within 2 hours from hospital admission
Secondary outcomes:
measure: Accuracy of the Large ARtery Intracranial Occlusion (LARIO) scale to identify a stroke with occlusion of a large vessels
timeFrame: within 2 hours from hospital admission
measure: incidence of hemorrhagic stroke
timeFrame: within 2 hours hospital admission
Other outcomes:
Locations:
city: Milan
country: Italy
facility: SOREU Metropolitana
Study officials:
affiliation: AREU
name: Anna Coppo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02148146: Use of Omega 3 Oil Emulsion for Parenteral Nutrition Associated Cholestasis
Official title: Clinical Trial of Omegaven™ Therapy for Parenteral Nutrition Associated Cholestasis
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Cholestasis
Keywords: short bowel syndrome
intestinal failure
total parenteral nutrition associated cholestasis
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2014-05-28
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no

Brief summary: This is a clinical study designed to evaluate the safety and benefit of a fish oil based fat emulsion in the treatment of liver disease associated with prolonged use of intravenous nutrition.

Detailed description: Specific Aims of Study

1. To determine the safety profile of an intravenous omega-3 fat emulsion (Omegaven™)
2. To determine if established PN associated liver disease can be reversed or its progression halted by using a parenteral fat emulsion prepared from fish oil as measured by normalization of serum levels of hepatic enzymes and bilirubin.

Eligibility criteria: Inclusion Criteria:

1. Age \< 18 years old
2. Patients will be PN dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require PN for at least another 30 days, may be inpatient or outpatient
3. Patients considered eligible for study participation must have parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of 2 mg/dl or more. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment
4. Direct bilirubin \> 2.0 mg/dl
5. Signed patient informed consent
6. The patient must have utilized standard therapies to prevent the progression of his/her liver disease including surgical treatment, cyclic PN, avoiding overfeeding, reduction/removal of copper and manganese from PN, advancement of enteral feeding, or the use of ursodiol (i.e., Actigall®)

Exclusion Criteria:

1. Pregnancy
2. Other causes of chronic liver disease (Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency)
3. Enrollment in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
4. The parent or guardian or child unwilling to provide consent or assent
5. Patients known to be allergic to fish or egg protein and patients with the following contraindications to Omegaven™ use:

   * Impaired lipid metabolism
   * Severe hemorrhagic disorders
   * Unstable diabetes mellitus
   * Collapse and shock
   * Stroke/embolism
   * Recent cardiac infarction
   * Undefined coma status

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UC San Diego Medical Center
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital of San Diego
state: California
Study officials:
affiliation: UC San Diego Medical Center
name: Sarah Lazar, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03730246: Pain After Cesarean Sectio.
Official title: Postoperative Pain 0-24 hr After Cesarean Sectio
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain
Analgesic Medication
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2018-11-05
Enrollment: 50
Sex: FEMALE
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients due for cesarean sectio are eligible

Brief summary: To study the strength of postoperative pain 0-24 hrs after elective cesarean sectio in spinal anaesthesia.


Eligibility criteria: Inclusion Criteria:

* cesearean sectio

Exclusion Criteria:

* none

Primary outcomes:
measure: postoperative pain strenght
timeFrame: 0-24 hrs
Secondary outcomes:
measure: rescue drug needed
timeFrame: 0-24 hrs
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Dept of Anesthesiology, Oslo University Hospital, Ullevaal
Study officials:
References:
Clinical trial NCT03309046: Interventions for Parent Caregivers of Injured Military/Veteran Personnel
Official title: Interventions for Parent Caregivers of Injured Military/Veteran Personnel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Brain Injuries, Traumatic
Keywords: Parents
Caregivers
Veterans
Lead sponsor: Memphis VA Medical Center
Sponsor class: FED
Collaborators: name: U.S. Army Medical Research and Development Command
First posted: 2017-10-13
Enrollment: 163
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized clinical trial will test a behavioral caregiving intervention that has been used successfully for dementia and spinal cord injury caregivers to provide services to stressed and burdened parent caregivers of post 9/11 service members/veterans. This intervention is six intensive individual sessions that will teach problem solving, cognitive restructuring and stress reduction targeted to an individual assessment of the care dyad's needs. It will be compared to another method of delivering content, education webinar sessions, which are analogous to the usual standard of care and will function as an attention control arm. The objective of the study is to determine which of these delivery mechanisms is more effective at helping parent caregivers of injured post 9/11 returning troops to improve their depression, anxiety, and burden, and to determine the feasibility of using individual sessions with this population of caregivers.


Eligibility criteria: Inclusion Criteria:

1. Identify as a parent who serves as the primary/main caregiver for a post 9/11 service member or veteran with a diagnosis of traumatic brain injury or post traumatic stress disorder or physical injury and at least 1 activity of daily living limitation or 2 or more instrumental of daily living limitations;
2. provide 3 hours or more of care per day for at least 6 months;
3. endorse at least 2 caregiving stress behaviors (overwhelmed, often needing to cry, angry/frustrated, cut off from family/friends, moderate/high levels of stress, and declining health); and
4. have a telephone.
5. Internet access is desirable but not mandatory.

Exclusion Criteria:

1. current diagnosis of schizophrenia or other major mental illness; or
2. auditory impairment that would make telephone use difficult

Primary outcomes:
measure: Depression - Patient Health Questionnaire - 9 (PHQ-9)
timeFrame: 6 months
measure: Anxiety - Generalized Anxiety Disorder (GAD-7). Time Frame: All Questions Refer to the Past Two Weeks.
timeFrame: 6 months
measure: Burden - Zarit Burden Interview (ZBI-12)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Memphis VA Medical Center
state: Tennessee
Study officials:
affiliation: Memphis VAMC
name: Linda O Nichols, PhD
role: PRINCIPAL_INVESTIGATOR
References: