louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01406860: Droperidol Versus Metoclopramide + Diphenhydramine for the Treatment of Primary Headaches
Official title: Droperidol Versus Metoclopramide + Diphenhydramine for the Treatment of Primary Headaches in the Emergency Department: A Prospective Randomized, Double-blinded Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Primary Headaches (Includes Migraines, Tension, Cluster Headaches)
Keywords: Headaches
Migraines
Tension headaches
Cluster headaches
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2011-08-01
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if droperidol is equally as effective as metoclopramide for treatment of primary headaches in the Emergency Department.


Eligibility criteria: Inclusion Criteria:

* 18 years old to 65 years old, diagnosis of primary headache

Exclusion Criteria:

* Allergy to study medications, pregnant, breast-feeding, prisoners, non-english speaking, not eligible to receive droperidol based on ED protocol (see below), patients in whom head trauma, infection, vascular disorders, and disorders of facial or cranial structures are suspected

ED Droperidol Protocol

Droperidol must NOT be used in patients with any of the following:

* Known or suspected QT prolongation, including congenital long QT syndrome
* Cardiac Disease \[cardiomyopathy, congestive heart failure, hypertension, ischemic heart disease, myocardial infarction, bradycardia (\< 50 bpm)\]
* History of the following:

  * Renal failure
  * Cerebrovascular disease
  * Diabetes or hypoglycemia
  * Alcoholism/alcohol abuse
  * Pituitary insufficiency
  * Hypothyroidism
  * Hypothermia
  * Anorexia
* Advanced age (\>65 yrs)
* Use of the following medications: digoxin, benzodiazepine, diuretics, IV opiates, or other medications known to prolong the QTc interval.

Primary outcomes:
measure: Pain Scale (Numerical Rating Scale for Pain)
timeFrame: Change in pain scores at 60 minutes from baseline as measured on the Numerical Rating Scale for Pain (NRS)
Secondary outcomes:
measure: Length of Stay
timeFrame: Participants will be followed for the duration of their emergency department visit after the initiation of treatment (Average Length of stay in minutes)
measure: 24 Hour Pain Score
timeFrame: 24 hours after discharge from ED
measure: Adverse Effects
timeFrame: From the time when the treatment is initiated until the 24 hour follow-up phone survey
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Jon Van Heukelom, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa
name: Christopher Hogrefe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa
name: Brett Faine, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05665660: Developing and Evaluating Culturally Relevant Interventions to Improve Breast Cancer Screening
Official title: Developing and Evaluating Scalable and Culturally Relevant Interventions to Improve Breast Cancer Screening Among White Mountain Apache Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: mammography
cancer screening
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Native American Research Center for Health
First posted: 2022-12-27
Enrollment: 350
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Women randomized to receive CARE who have not received a mammography at 3 months will be offered CARE+COACH to facilitate completion of their screening and contacted at 4 months.
Primary purpose: SCREENING

Brief summary: The goal of this study is to evaluate the relative benefits of an intervention to promote breast cancer screening among women in the White Mountain Apache (WMA) community. Women will be randomized to receive CARE, a culturally tailored mammography education module, or CARE+COACH, which is the CARE education module plus access to an Apache paraprofessional women's health coach (i.e., patient navigator). The CARE intervention was developed through a community-based participatory research process. The primary outcome is mammography uptake within 2 months of a referral.


Eligibility criteria: Inclusion Criteria:

* Referral for screening mammography from a Whiteriver Indian Health Service provider
* Self-identify as American Indian or Alaska Native (AIAN)
* Female
* Live on within 60 miles of the Fort Apache Indian Reservation

Exclusion Criteria:

* Women who have received a mammogram within the prior 12 months
* Women with a personal history of breast cancer
* Unable to participate in full intervention or evaluation due to an anticipated event (e.g., planned move)
* Unwilling to be randomized

Primary outcomes:
measure: Mammography uptake
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Whiteriver
country: United States
facility: Center for Indigenous Health
state: Arizona
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Allison Barlow, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02054260: Surgicel® (Fibrillar) in Non-variceal UGI Bleeding
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-variceal Upper Gastrointestinal Bleeding
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
First posted: 2014-02-04
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT

Brief summary: The aim of this study is to assess of effect of Surgicel® (Fibrillar) for preventing delayed bleeding after endoscopic hemostasis in non-variceal upper gastrointestinal bleeding


Eligibility criteria: Inclusion Criteria:

* Patients with non variceal upper gastrointestinal bleeding proven by esophagogastroduodenoscopy
* Patients with active bleeding (Forrest classification Ia or Ib or IIa)

Exclusion Criteria:

* Patients with upper gastrointestinal tract malignancy
* Patients with acute severe illness
* Coagulopathy: liver cirrhosis, thrombocytopenia
* Pregnant women

Primary outcomes:
measure: Rebleeding rate at the second look endoscopy
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Digestive Disease Center and Research Institute, Department of Internal Medicine, Soonchunhyang University College of Medicine
Study officials:
References:
Clinical trial NCT00931060: Effects of Branched-Chain Amino Acids on Muscle Ammonia Metabolism in Patients With Cirrhosis and Healthy Subjects
Official title: Effects of Branched-Chain Amino Acids on Muscle Ammonia Metabolism in Patients With Cirrhosis and Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Diseases
Hepatic Encephalopathy
Hepatic Insufficiency
Keywords: Ammonia
Citric acid cycle
Branched Chain Amino Acids
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2009-07-02
Enrollment: 24
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine whether Branched chain Amino Acids enhances the uptake of ammonia in muscle tissue.

Detailed description: Branched-chain amino acids (BCAA; leucine, valine, isoleucine) are used to prevent hepatic encephalopathy in cirrhotic patients. The main effect of BCAAs is believed to take place in muscles where BCAAs provide carbon-skeletons for the TCA-cycle. This enhances the conversion of alfa-ketoglutarate to ammonia via glutamine.

We intend to study the effect of oral administered BCAA on the metabolism of ammonia and amino acids across the leg-muscles by means of catheters inserted into the femoral artery (A) and vein (V). Muscle blood flow (F; L/min) will be determined by constant infusion of indocyanine green and indicator dilution principle. Arterial blood flow and A and V concentrations of ammonia and amino acids will be measured before an oral load of BCAA (0.45 g BCAA/kg body weight) and after 1 and 3 hours. The metabolism of ammonia will also be estimated by means of 13N-NH3 PET scans.

Hypothesis: BCAA increases the uptake of ammonia in muscle tissue and lowers arterial ammonia.

Eligibility criteria: Inclusion Criteria:

* 18 patients with liver cirrhosis
* 6 healthy subjects age and sex matched

Exclusion Criteria:

* Non-treated diabetes
* Pregnancy/breast-feeding

Primary outcomes:
measure: arterial ammonia concentration
timeFrame: 1 and 3 hours
Secondary outcomes:
measure: muscle ammonia metabolism
timeFrame: 1 hour and 3 hours
Other outcomes:
Locations:
Study officials:
affiliation: PET Centre and Medical department V, Aarhus Sygehus, Aarhus University Hospital
name: Susanne Keiding, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03271060: Comparative Study Between Posterior Lumbar Interbody Fusion(PLIF) and Intertransverse Process Fusion in Treatment of Spodylolithesis
Official title: Comparative Study Between Posterior Lumbar Interbody Fusion(PLF) and Intertransverse Process Fusion in Treatment of Spodylolithesis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Spondylolisthesis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Posterior inter body fusion and inter transverse process bone graft
Primary purpose: TREATMENT

Brief summary: The first technique described for interbody fusion was the anterior lumbar interbody fusion (ALIF).(20) For this technique, the intervertebral disc is accessed through a retroperitoneal or transperitoneal approach.

While the posterior approach was first described by Russell Hibbs in 1911, in the 1950's, Cloward (7)popularized the posterior approach for a posterior lumbar interbody fusion (PLIF).

Detailed description: In this study we will try to identify the benefits and outcome of posterior lumbar interbody fusion and inter transverse process bone graft fusion.

Eligibility criteria: Inclusion Criteria:

* lumbar spondylolisthesis

Exclusion Criteria:

* infection of lumbar spine

Primary outcomes:
measure: Back pain
timeFrame: 1year postoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03627260: How Useful is the Advice: "Fill up a Handful of Sunscreen and Spread it All Over Your Body"
Official title: How Useful is the Advice: "Fill up a Handful of Sunscreen and Spread it All Over Your Body"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quantity of Sunscreen
Sun Protection Factor
Sun Safety Campaigns
Sunscreen Use
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2018-08-13
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The advice: "Fill up a handful of sunscreen and spread it all over your body" is used in several sun safety campaigns. The hope is that users in swimwear following the advice will apply a sunscreen quantity of 2 mg/cm\^2 to all accessible skin. The present study is the first to investigate how this advice works in practice.


Eligibility criteria: Inclusion Criteria:

- European descent

Exclusion Criteria:

* Skin disease
* allergy to the content in sunscreen
* Pregnancy
* Breastfeeding

Primary outcomes:
measure: The overall quantities of sunscreen applied were calculated from the weighed amount of sunscreen used divided by the skin area accessible for sunscreen application.
timeFrame: Outcome measure will be assessed within half an hour after sunscreen application. There will be no further follow up.
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen NV
country: Denmark
facility: Bispebjerg Hospital
state: DK
Study officials:
References:
Clinical trial NCT01020760: Protocol for RCT of Posturing in Phacovitrectomy for Full Thickness Macular Hole (FTMH)
Official title: Pilot Study of Prone Posturing Following Phacovitrectomy for Thickness Macular Hole
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Full Thickness Macular Hole
Keywords: Macular hole
Vitrectomy
Prone posturing
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
First posted: 2009-11-26
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of postoperative posturing on the outcome of macular hole surgery. Current practice is divided; some individuals are advised to posture face-down for 10 days and others are advised that posturing is unnecessary. By evaluating the effect of posturing in a prospective randomised controlled trial the investigators hope to determine best practice, enabling surgeons and patients to make informed decisions regarding postoperative management.


Eligibility criteria: Inclusion Criteria:

1. Patients having surgery for idiopathic full thickness macular hole
2. Able and willing to posture face-down for 10 days postoperatively
3. Agree to participate in the trial and able to give informed consent

Exclusion Criteria:

1. History of visual loss suggesting a duration of macular hole greater than 12 months
2. Patients unable or unwilling to posture face-down for 10 days postoperatively
3. History of trauma that may have been causative
4. Age less than 16 years (in practice idiopathic macular hole is extremely rare in patients under 30 years).
5. Previous vitrectomy surgery
6. Additional retinal breaks occurring during surgery that necessitate post-operative posturing to prevent retinal detachment.

Primary outcomes:
measure: estimate variance and effect size order to inform power calculations for further studies.
timeFrame: one year
Secondary outcomes:
measure: visual acuity and complications
timeFrame: one year
measure: estimate recruitment rate and establish protocol/procedure
timeFrame: one year
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Gartnavel General Hospital
Study officials:
References:
citation: Yorston D, Siddiqui MA, Awan MA, Walker S, Bunce C, Bainbridge JW. Pilot randomised controlled trial of face-down posturing following phacovitrectomy for macular hole. Eye (Lond). 2012 Feb;26(2):267-71. doi: 10.1038/eye.2011.220. Epub 2011 Sep 23.
Clinical trial NCT03025360: Expanded Access to Provide Larotrectinib for the Treatment of Cancers With a NTRK Gene Fusion
Official title: Expanded Access to Provide Larotrectinib (LOXO-101) for the Treatment of Cancers With a NTRK Gene Fusion
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Tumors Harboring NTRK Fusion
Keywords: Neurotrophic tyrosine receptor kinase (NTRK)
NTRK1
NTRK2
NTRK3
Fusion Positive
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2017-01-19
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Larotrectinib expanded access is for patients with cancer with a NTRK1, NTRK2, or NTRK3 gene fusion, who are ineligible for an ongoing larotrectinib clinical trial or have other considerations that prevent access to larotrectinib through an existing clinical trial. Gene fusion occurs when a gene is made by joining parts of two different genes. NTRK gene fusion can lead to the development of solid tumors in a variety of tissue types. The study drug larotrectinib blocks the action of the NTRK gene fusion.

Expanded access is intended to treat individual patients with different types of cancers with a NTRK gene fusion who are unresponsive to current standard treatment for their condition and also are unable to participate in ongoing clinical trials.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of cancer with a NTRK1, NTRK2, or NTRK3 gene fusion
* Subjects are unable to participate in an ongoing larotrectinib clinical trial
* Medically suitable for treatment with larotrectinib

Exclusion Criteria:

* Currently enrolled in an ongoing clinical study of larotrectinib or another TRK inhibitor

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03178760: Determination of Normal Measures of Optic Nerve Sheath Diameter in Children
Official title: Determination of Normal Measures of Optic Nerve Sheath Diameter in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Optic Papilla Edema
Keywords: Optic nerve sheath diameter
average optic nerve sheath diameter for healthy children
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2017-06-07
Enrollment: 200
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients without cerebral edema applied the emergency care unit.

Brief summary: The purpose of this study is to measurement of optic nerve sheath diameter in children without intracranial pressure increase and determine the average optic nerve sheath diameters for healthy children.

Detailed description: The purpose of this study is to measurement of optic nerve sheath diameter in children without intracranial pressure increase and determine the average optic nerve sheath diameters for healthy children. For that, between 4 and 18 years old children will be selected. After taking of measurements, following parameters will be taken into account and measurements will be classified with those parameters .

1. Age
2. Gender
3. Length (cm)
4. Weight (kg)
5. Waist Circumference (cm)
6. Body Mass Index

Eligibility criteria: Inclusion Criteria:

• Children without cerebral edema.

Exclusion Criteria:

• Children with cerebral edema.

Primary outcomes:
measure: Measurement of optic nerve sheath diameter
timeFrame: 1-3 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University
Study officials:
References:
Clinical trial NCT04360460: Role of Functional Translation After Immersive Virtual Reality Exposure in Persons With Stroke
Official title: Role of Functional Translation After Immersive Virtual Reality Exposure in Persons With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiparesis as Late Effect of Cerebrovascular Disease
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single-blinded randomized control trial aiming to explore the use of immersive virtual reality (VR) training in conjunction with real-life tasks therapy in 75 first time stroke patients with upper limb weakness.

Detailed description: Patients will be randomized to a control or experimental group. The experimental group will receive immersive VR training followed by the translation of related tasks in a real life environment. The control group will perform the same tasks in a real life environment but will receive immersive VR exposure to a non-related task.

Eligibility criteria: Inclusion Criteria:

1. 18-90 years old
2. Hospitalized at Loma Linda East Campus Rehabilitation Hospital
3. First time stroke patient
4. Upper limb hemiparesis
5. English-speaking
6. Manual muscle testing of at least 2/5 in 3 or more muscle groups in affected upper limb

Exclusion Criteria:

1. Active neck pain, headaches, or vertigo limiting ability to tolerate Virtual Reality Head Mounted Device
2. Patients with hemicraniectomy
3. Current uncontrolled seizures
4. Active infections requiring contact precautions
5. Cognitively unable to participate
6. Vision loss limiting ability to participate with VR therapy

Primary outcomes:
measure: Motor Activity Log
timeFrame: Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)
Secondary outcomes:
measure: Modified Barthel's Index
timeFrame: Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)
measure: Fugl-Meyer Upper Extremity Assessment
timeFrame: Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)
measure: Montreal Cognitive Assessment
timeFrame: Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)
measure: Functional Independence Measurement Score
timeFrame: Change in score (between baseline and time of discharge from rehabilitation hospital, about 2 weeks)
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Tom and Vi Zapara Rehabilitation Pavilion
state: California
Study officials:
affiliation: Loma Linda University
name: Christopher Tarver, MD
role: PRINCIPAL_INVESTIGATOR
References: