louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01977001: Use of MigraineBoxTM Head and Neck Cooling Bath for Treatment of Primary Headache in the Emergency Department
Official title: Use of MigraineBoxTM Head and Neck Cooling Bath for Treatment of Primary Headache in the Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Headache
Keywords: Primary headache
Headache
MigraineBox
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
First posted: 2013-11-06
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to the emergency department at an urban county hospital.

Brief summary: MigraineBoxTM is a simple, contoured cooling bath for the head and neck. Effectiveness of MigraineBoxTM will be studied in primary headaches in the emergency department. The user simply reclines his/her head and neck into this device that has contours that support the head and neck. Luke warm water is filled into the MigraineBoxTM before use and then a frozen insert is placed inside. This will gradually cool the water surrounding the patient's head and theoretically provide headache relief.


Eligibility criteria: Inclusion Criteria:

* 18-85 years old
* Benign headache
* Physician intends to treat headache pain in the ED with either droperidol, prochlorperazine, or a parenteral narcotic

Exclusion Criteria:

* Unable to provide informed consent
* Headache due to trauma, subarachnoid hemorrhage, meningitis, intracerebral bleed, cranial tumor, sinusitis, dental pathology, temporomandibular joint dysfunction, glaucoma, or systemic infection
* Known renal impairment
* Known hepatic impairment
* A history of coronary artery disease, peripheral vascular disease, or cerebrovascular disease
* Perforated ear drum
* Pregnant

Primary outcomes:
measure: Change from Baseline in Pain Level
timeFrame: Baseline, 30 minutes, 60 minutes
Secondary outcomes:
measure: Change from Baseline in Nausea
timeFrame: Baseline, 30 minutes, 60 minutes
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
affiliation: Hennepin Healthcare Research Institute
name: James R Miner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01691001: Effect of Dexmedetomidine on Sevoflurane Requirements and Emergence Agitation in Children Undergoing Ambulatory Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ambulation Difficulty
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-09-24
Enrollment: 40
Sex: MALE
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although the aetiology of emergence agitation (EA) derives from multiple factors, it is a frequent side effect of sevoflurane anaesthesia in children. Dexmedetomidine, a potent selective α2-adrenergic agonist, can reduce the doses of hypnotics, opioids, analgesics, and anaesthetics that must be concomitantly administered. This study was conducted to assess the effect of dexmedetomidine infusion on sevoflurane requirements and recovery profiles with EA in children undergoing ambulatory surgery.


Eligibility criteria: Inclusion Criteria:

* ASA class I
* obtaining written informed consent from the parents
* aged 1-5 years, and weighing \<20 kg who were undergoing ambulatory hernioplasty or orchiopexy

Exclusion Criteria:

* mental retardation
* developmental delays
* neurological or psychiatric illnesses
* coagulation disorder
* spinal anomalies
* bilateral procedures

Primary outcomes:
measure: the reduction rate of ET-sevo in achieving BIS scores from 45-50
timeFrame: 2 hour(during whole operation period)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT00625001: Long Term Follow-up of Bone Mineral Density in Hormone Treated Turner Syndrome
Official title: Long Term Follow-up of Bone Mineral Density in Hormone Treated Turner Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Turner Syndrome
Keywords: Turner Syndrome
bone mineral density
estrogen replacement therapy
dual energy x-ray absorptiometry
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2008-02-28
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with Turner syndrome

Brief summary: Turner Syndrome (TS) is associated with osteopenia and osteoporosis. Reduced bone mineral density (BMD) and increased risk of fractures are present in many younger and middle-aged women with TS. The objective is therefore to describe longitudinal changes in BMD in TS.

The study is an observational follow-up study. Examinations at baseline, after 5 and 10 years.

Bone mineral density is measured by dual energy x-ray absorptiometry (DEXA) and bone turnover by bone markers.

Main Outcome Measures: Bone mineral density (BMD; grams/ square centimetre) were measured at lumbar spine, hip and the non-dominant forearm.


Eligibility criteria: Inclusion Criteria:

* Turner syndrome verified by karyotyping

Exclusion Criteria:

* untreated hypothyroidism or hyperthyroidism
* present or past malignant diseases
* clinical liver disease
* treatment with drugs known to interfere with bone metabolism (e.g. glucocorticoids)

Primary outcomes:
measure: Bone Mineral Density in columna lumbalis, collum femoris and distal ulnae Bone mineral density (BMD; grams/ square centimetre) were measured at lumbar spine, hip and the non-dominant forearm.
timeFrame: Evey 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01488201: A Clinical Pharmacology of KHK4827 in Healthy Volunteers and Subject With Moderate to Severe Psoriasis
Official title: A Randomized, Placebo-controlled, Ascending Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KHK4827 in Healthy Volunteers and Subjects With Moderate to Severe Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis
Keywords: Psoriasis
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-12-08
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, placebo-controlled, ascending single dose study of KHK4827 to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous or intravenous administration of KHK4827 in healthy male subjects or moderate to severe psoriasis patients.


Eligibility criteria: Inclusion Criteria:

Health volunteers

* Able to provide written informed consent
* Healthy male between 20 to 45 years of age, inclusive at the time of screening
* Additional inclusion criteria apply

Psoriasis subjects

* 20 to 70 years of age, inclusive at the time of screening
* Active but clinically stable, plaque psoriasis
* Psoriasis involving ≥10% of the body surface area
* A minimum PASI score of ≥10 obtained during the screening period
* Additional inclusion criteria apply

Primary outcomes:
measure: Safety
Secondary outcomes:
measure: Plasma KHK4827 concentrations and pharmacokinetic parameters
timeFrame: 16 time points up to 64 days
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
References:
Clinical trial NCT00939601: Evaluating Behavioral Treatments to Improve Adherence to CPAP in People With Obstructive Sleep Apnea
Official title: Evaluating Behavioral Treatments to Improve Adherence to Continuous Positive Airway Pressure (CPAP) Therapy in People With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adherence to CPAP in Obstructive Sleep Apnea
Keywords: Obstructive Sleep Apnea
OSA
Adherence
CPAP
Cognition
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: Rhode Island Hospital
First posted: 2009-07-15
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Obstructive sleep apnea (OSA) is a serious sleep disorder in which a person repeatedly stops breathing or experiences shallow breathing for short periods of time during sleep. The most common treatment for OSA is the use of a continuous positive airway pressure (CPAP) machine, but many people have trouble adhering to the treatment schedule. This study will evaluate the effectiveness of two behavioral therapy programs used in combination with CPAP for improving treatment adherence in people with OSA.


Eligibility criteria: Inclusion Criteria:

* OSA confirmed by polysomnography (PSG)
* CPAP is the prescribed form of treatment for OSA
* Judged by sleep physician to respond to CPAP

Exclusion Criteria:

* Apnea/hypoxia index (AHI) less than 15
* Diagnosis of another sleep disorder that causes arousals from sleep
* Past treatment for OSA
* Current substance abuse problem
* Diagnosis of a serious medical condition that would interfere with involvement in the study
* History of a major psychiatric disorder, other than depression
* Change in antidepressant medication in the 3 months before study entry

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Aloia MS, Knoepke CE, Lee-Chiong T. The new local coverage determination criteria for adherence to positive airway pressure treatment: testing the limits? Chest. 2010 Oct;138(4):875-9. doi: 10.1378/chest.09-2237. Epub 2010 Mar 26.
Clinical trial NCT02425501: Special Drug Use Investigation of EYLEA for Diabetic Macular Edema
Official title: Special Drug Use Investigation of EYLEA for Diabetic Macular Edema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Edema
Keywords: Aflibercept
anti-VEGF
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-04-24
Enrollment: 646
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female and male patients with DME diagnosis will be enrolled after the investigators have taken the decision for the treatment with EYLEA. Those patients who have had EYLEA prescribed previously will not be included in this study. Physicians should consult the full prescribing information for EYLEA before enrolling patients and be familiarized with the safety information in the product package label.

Brief summary: The objectives of this study are to investigate the safety and effectiveness of EYLEA

Detailed description: This is a prospective, non-interventional, multi center post-authorization safety study that includes patients with a diagnosis of myopic choroidal neovascularization. The investigator will have made the choice of treatment (EYLEA) as well as the decision to use EYLEA according the Japanese Package Insert prior to enrolling the patient in this study.

The observation period for each patient starts when therapy with EYLEA is initiated. The enrollment period is 2 years. Patients will be followed for a time period of 2 years or until it is no longer possible (e.g. lost to follow-up) within the 2 years. In total, 600 patients will be recruited.

For each patient, data are collected as defined in the electronic case report form (eCRF) at the initial visit, follow-up visits and final visit, either by routine clinical visits (as per investigators routine practice).

Eligibility criteria: Inclusion Criteria:

* Patients who start EYLEA treatment for Diabetic Macular Edema (DME)

Exclusion Criteria:

* Patients who have already received EYLEA treatment

Primary outcomes:
measure: Number of participants of Adverse Events
timeFrame: Up to 12 months
measure: Number of participants of Serious Adverse Events
timeFrame: Up to 12 months
Secondary outcomes:
measure: Mean change in visual acuity from baseline to 12 months
timeFrame: Baseline to 12 months
measure: Mean change in retina thickness from baseline to 12 months
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Sugimoto M, Handa C, Hirano K, Sunaya T, Kondo M. Intravitreal aflibercept for diabetic macular edema in real-world clinical practice in Japan: 24-month outcomes. Graefes Arch Clin Exp Ophthalmol. 2022 Nov;260(11):3489-3498. doi: 10.1007/s00417-022-05703-9. Epub 2022 Jun 2.
Clinical trial NCT04950101: Prevalence of Anal High-risk Human Papilloma Virus Infection and Abnormal Anal Cytology in Men Who Have Sex With Men Using Pre Exposure Prophylaxis
Official title: Prevalence of Anal High-risk Human Papilloma Virus Infection and Abnormal Anal Cytology in Men Who Have Sex With Men Using Pre Exposure Prophylaxis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Human Papilloma Virus
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2021-07-06
Enrollment: 304
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SCREENING

Brief summary: The aim of the study is to determine the prevalence of anal high-risk HPV infection and abnormal cytology in HIV uninfected Men who have sex with men (MSM) using PrEP and HIV infected MSM followed-up at the S-kliniek or HRC of the UZ Brussel. 200 participants will be preferably included in the study. The data will be collected using a self-administered questionnaire where socio-demographic characteristics, health-related issues and sexual behavior will be questioned. Also anal canal sampling will be performed for cytological analysis. For the HIV infected MSM, additional information will be extracted from the patient files: CD4+ T-cell count and nadir and duration of combination antiretroviral therapy.


Eligibility criteria: Inclusion Criteria:

* HIV uninfected MSM of 18 years or older using PrEP since at least 3 months
* HIV-infected MSM of 18 years or older

Exclusion Criteria for MSM using PrEP:

* Any intervention in the (peri-) anal region in the past 3 months
* enema within 24h before sampling
* receptive anal sex within 24h before sampling
* current/ongoing peri-anal topical HPV-treatment

Exclusion Criteria for MSM infected with HPV:

* none

Primary outcomes:
measure: To determine the prevalence of anal high risk HPV infection in MSM using PrEP
timeFrame: 2 year
Secondary outcomes:
measure: To compare the prevalence of high risk HPV in MSM using PrEP with that of HIV uninfected MSM not using PrEP
timeFrame: 2 year
measure: To compare the prevalence of high risk HPV in MSM using PrEP with that of HIV infected MSM
timeFrame: 2 year
measure: to determine the prevalence of abnormal anal cytology in MSM using PrEP and in HIV infected MSM
timeFrame: 2 year
Other outcomes:
measure: to determine the correlation between abnormal cytology and HPV infection in MSM using PrEP
timeFrame: 2 year
measure: To determine possible correlations between the characteristics asked in the questionnaire and the prevalence of high risk HPV infection in both MSM using PrEP and MSM who have HIV
timeFrame: 2 year
Locations:
city: Brussels
country: Belgium
facility: Universitair ziekenhuis Brussel
Study officials:
References:
Clinical trial NCT05540301: Sleeper's and Adduction Stretch to Increase Shoulder ROM
Official title: Effectiveness of Modified Sleeper Stretch And Modified Cross-Body Adduction Stretch To Increase Shoulder Internal Rotation Range of Motion In Tennis Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stiffness of Shoulder, Not Elsewhere Classified
Keywords: Sleeper Stretch
Cross-Body Stretch
Range of Motion
Shoulder
Tennis Players
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-group two-factor research design was used.
Primary purpose: TREATMENT

Brief summary: The study aimed to compare the efficacy of modified sleeper stretch and modified cross-body adduction stretch in improving shoulder internal rotation range of motion and upper limb function. Thirty male lawn tennis players aged between 20 to 35, with more than 150 glenohumeral internal rotation deficiency (GIRD) on the dominant shoulder (compared to the nondominant side) participate in the study and divided into two groups (A and B). Group A received a modified sleeper stretch and group B received a modified cross-body adduction stretch for four weeks, five times per week. The outcome measures were the internal rotation range of motion measured by a universal goniometer and upper limb functions measured by the Disability of the Arm, Shoulder, and Hand (DASH) scale.


Eligibility criteria: Inclusion Criteria:

* Lawn Tennis Players
* Male
* more than 15 degree glenohumeral internal rotation deficiency

Exclusion Criteria:

* systemic or metabolic disorders
* a positive test for labral lesions or rotator cuff tears
* a history of recent fracture
* a history of orthopaedic surgery in the upper limbs or cervical region

Primary outcomes:
measure: Internal rotation range of motion
timeFrame: 4 weeks.
measure: Upper limb functions
timeFrame: 4 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Saud University
Study officials:
affiliation: King Saud University
name: Masood Khan, M.P.Th
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02151201: Impact of Influenza Vaccination in Pregnancy Video Education
Official title: Impact of Video Education on Influenza Vaccination Rate in Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Keywords: pregnancy vaccination influenza education
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2014-05-30
Enrollment: 105
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: We evaluated the impact of viewing an educational video about influenza vaccination in pregnancy just prior to a routine prenatal visit on vaccination health beliefs and vaccination rate. We hypothesized that the video would positively impact both vaccination health beliefs and vaccination rate compared to a control video.

Detailed description: We studied the impact of influenza in pregnancy video education that was developed by the CDC and currently available to the public on the internet. We looked to see if viewing the video just prior to a routine scheduled prenatal visit could positively influence health beliefs regarding vaccination and improve the rate of vaccination that day. Patients were randomized to view the intervention video or a control video of similar length about hand washing. Pre visit and post visit questionnaires were given about vaccination health beliefs. We also asked if the shot had been recommended by the physician. One month after the visit, we used a structured phone interview to gather additional information regarding why participants who had not been vaccinated made that choice.

Eligibility criteria: Inclusion Criteria:

* pregnant
* English as primary language
* scheduled for a routine prenatal visit
* no documented influenza vaccination 2013-2014

Exclusion Criteria:

* Cleveland Clinic Employee
* high risk pregnancy
* allergy to eggs
* allergy to influenza vaccination

Primary outcomes:
measure: Influenza Vaccination Rate
timeFrame: day of the prenatal visit
Secondary outcomes:
measure: Influenza Vaccination in Pregnancy Health Beliefs
timeFrame: day of the prenatal visit
measure: Influenza vaccination in pregnancy health beliefs
timeFrame: Day of the appointment
Other outcomes:
measure: Provider recommendation to become vaccinated
timeFrame: day of the appointment
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Kenneth Goodman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01575301: DIabetes REsearCh on Patient sTratification (DIRECT): GLP-1R Agonists
Official title: DIabetes REsearCh on Patient sTratification (DIRECT): GLP-1R Agonists
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: GLP-1R agonist
biomarker
Lead sponsor: University of Dundee
Sponsor class: OTHER
Collaborators: name: Newcastle-upon-Tyne Hospitals NHS Trust
name: Oxford University Hospitals NHS Trust
name: Royal Devon and Exeter NHS Foundation Trust
First posted: 2012-04-11
Enrollment: 411
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to collect a cohort of patients treated with GLP-1R Agonists and to assess phenotypic, genetic and genomic biomarkers of glycaemic response to these agents.

Detailed description: To develop a cohort of patients treated with GLP-1 R Agonists who are phenotyped at baseline and at 6 month follow up to determine clinical, imaging and other biomarker predictors of glycaemic response to GLP-1R Agonists. The hypothesis is that one, or a combination, of these biomarkers is associated with glycaemic response to GLP-1R Agonists. The primary outcome is therefore HbA1c reduction after 6 months of GLP-1R A treatment.

This is a cohort study of 800 patients being treated with either exenatide or liraglutide for 6 months, and carried out in 4 UK centres.

Eligibility criteria: Inclusion Criteria:

* Patients with Type 2 diabetes where a clinical decision has been made to commence a GLP-1R agonist
* Either:

  1. On any combination of oral hypoglycaemic agents
  2. On Insulin (+/- oral hypoglycaemic agents)
* HbA1c ≥7.5% (58mmol/mol) and HbA1c \< 12% (108mmol/mol)
* White European
* Age ≥ 18 and \< 80

Exclusion Criteria:

* Type 1 diabetes
* HbA1c \<7.5% (58 mmol/mol)
* HbA1c ≥ 12% (108 mmol/mol)
* Pregnancy or lactation
* Any other significant medical reason for exclusion as determined by the investigator
* Inability to consent
* Participating in a CTIMP during the study period and within 30 days prior to study start.

Primary outcomes:
measure: Change in HbA1c between baseline and 6 months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
state: Angus
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter NHS Foundation Trust
state: Devon
city: Oxford
country: United Kingdom
facility: Oxford Hospitals NHS Trust
state: Oxfordshire
city: Newcastle
country: United Kingdom
facility: Newcastle Hospitals NHS Trust
state: Teeside
Study officials:
affiliation: University of Dundee
name: Ewan Pearson
role: PRINCIPAL_INVESTIGATOR
References: