louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01062074: GARDASIL Reexamination Study (V501-059)
Official title: Re-examination Study for General Vaccine Use to Assess the Safety Profile of GARDASIL in Usual Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Papillomavirus (HPV) Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-02-04
Enrollment: 3605
Sex: ALL
Minimum age (years): 9
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Females and males 9-26 Years Of Age who are vaccinated with GARDASIL in usual practice

Brief summary: This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of Gardasil through collecting the safety information according to the Re-examination Regulation for New Drugs.


Eligibility criteria: Inclusion Criteria:

* Females and males 9-26 years of age who Are Vaccinated With The First Dose Of Gardasil For The Prevention Of Any Disease Caused By Human Papillomavirus (e.g., Cervical Cancer, Genital Warts, etc.) Within Local Labeling

Exclusion Criteria:

* Participant Who Has A Contraindication To Gardasil According To The Local Label
* Participants Who Are Vaccinated With Gardasil Before Study Start

Primary outcomes:
measure: Percentage of Participants With Any Adverse Experience
timeFrame: Up to 14 days after any GARDASIL vaccination
measure: Percentage of Participants With Any Adverse Drug Reaction
timeFrame: Up to 14 days after any GARDASIL vaccination
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01112774: Application of Transcranial Direct Current Stimulation (tDCS) in Patients With Chronic Pain After Spinal Cord Injury
Official title: Investigation of the Mechanisms of Transcranial Direct Current Stimulation of Motor Cortex for the Treatment of Chronic Pain in Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: Transcranial direct current stimulation
Spinal cord injury
Chronic pain
Brain excitability
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2010-04-28
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the novel treatment of transcranial direct current stimulation (tDCS) could decrease the pain perception of those with spinal cord injury.

We will also determine whether these changes are correlated with the clinical outcome (pain reduction).

Detailed description: The active tDCS stimulation sessions will be compared to sham stimulation.

More study details will be provided by Spaulding Rehabilitation Hospital.

Eligibility criteria: STUDY ELIGIBILITY CRITERIA (similar to the criteria of the Interstitial Cystitis Network)

1. Providing informed consent to participate in the study
2. 18 to 64 years old
3. with traumatic spinal cord injury (complete or incomplete) - for instance, due to fall, car accident or gun shot; (for spinal cord injury only)
4. stable chronic pain for at least the three preceding months(for spinal cord injury only)
5. score higher or equal to 4cm (0 cm= 'no pain' and 10cm='worst possible pain') on the Visual Analogue Scale (VAS) for pain perception at the baseline/start of the treatment(for spinal cord injury only)
6. refractoriness to drugs for pain relieve - such as tricyclic antidepressants, antiepileptic drugs and/or narcotics (pain resistant to at least 2 of these drugs supplied in adequate dosages for six months) (for spinal cord injury only)
7. pain is not attributable to other causes, such as peripheral inflammation.
8. No clinically significant or unstable medical or psychiatric disorder
9. No history of substance abuse
10. No neuropsychiatric comorbidity
11. No implanted devices for pain control, such as vagal or deep brain stimulators
12. No contraindications to tDCS:

    * metal in the head
    * implanted brain medical devices
13. No pregnancy
14. Eligible to MRI according to MRI screening checklist.
15. No use of ventilators

Primary outcomes:
measure: Neurophysiological activity changes after treatment with tDCS
timeFrame: baseline, 2 weeks treatment and follow up (2 weeks)
Secondary outcomes:
measure: Pain changes
timeFrame: Baseline, 2 weeks treatment and follow up (2 weeks)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital
name: Felipe Fregni, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00422474: Prognostic Significance of the Baroreflex Sensitivity Changes After Acute Ischemic Stroke
Official title: Noninvasive Study of the Time Course of Baroreflex Sensitivity 6-Month After Acute Ischemic Stroke and the Relation of Its Changes With Post Stroke Prognosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebrovascular Accident
Baroreflexes
Autonomic Nervous System Diseases
Keywords: Ischemic stroke
Baroreflex sensitivity
Prognosis
Cardiovascular autonomic regulation
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2007-01-17
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: After acute stroke, baroreflex sensitivity (BRS) is impaired. This impaired acute stage BRS has been reported to be predictive of worsen outcome years after stroke in general. However, it is not very clear if the impaired acute stroke BRS would actually persist months after the acute stage. It is also not clear that such change, if any, would correlate with the functional outcome or prognosis after stroke.

The trial is to investigate the longitudinal time course of BRS after ischemic stroke up to the 6th month post stroke and to see if there is any correlation of the changes in BRS with the functional outcome parameters using NIHSS and mRS scores throughout this period.


Eligibility criteria: Inclusion Criteria:

* Baroreflex sensitivity can be done within 72 hours of onset of acute ischemic stroke
* 50-80 years old
* Must have either brain CT or brain MRI done

Exclusion Criteria:

* NIHSS score \> 10
* Patient could not cooperate
* Unstable vital sign
* Atrial fibrillation
* Transient ischemic attack patient
* Diabetic patient
* Impaired renal function (Cr \> 2.26 mg/dl)
* Unstable angina, acute myocardiac infarction, cardiomyopathy patients
* Patient who has known autonomic dysfunction

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Panchiao City
country: Taiwan
facility: Far Eastern Memorial Hospital
state: Taipei County
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Siupak Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05376774: Prediction Model of Vitamin D Deficiency
Official title: Prediction Model of Vitamin D Deficiency in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Keywords: critical care
vitamin D
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 662
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients

Brief summary: Many studies have pointed out that patients with vitamin D deficiency have a longer stay in the intensive care unit and a poor prognosis. Previous multi- center prospective observational study in Taiwan reveals that the prevalence of vitamin D deficiency in critically ill patients in northern Taiwan is 59%, and the prevalence of severe vitamin D deficiency is 18%. Several prediction models of vitamin D deficiency had been built for the general population but not patients admitted in intensive care units.

This multi-center retrospective study aims to develop and validate a score-based prediction model for severe vitamin D deficiency in critically ill patients. Investigators will review the data of previous multicenter, prospective, observational study. For temporal validation, the data will be divided into a derivation cohort (first 80% of the data set based on chronology) and a validation cohort (the remaining data set). The development and validation of the models will be carried out following the recommendations established in the Transparency Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD) initiative.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to intensive care units

Exclusion Criteria:

* aged \< 20 years
* admitted to intensive care unit longer than 28 days
* body max index \< 18 kg/m2
* receive vitamin D supplement \> 3000 IU/day
* previously admitted to intensive care unit within 3 months
* have parathyroid disease, rickets, or severe liver cirrhosis \[Child C\]

Primary outcomes:
measure: Performance of the score-based prediction model
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Department of Anesthesiology, National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT05349565: Effects of Muscle Energy Technique in Knee Osteoarthritis Patients
Official title: Effects of Muscle Energy Technique Along Conventional Physical Therapy After Mesenchymal Stem Cell Transplantation in Knee Osteoarthritis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Mesenchymal stem cells (MSCs),
muscle energy technique (MET),
rehabilitation protocol
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 26
Sex: ALL
Minimum age (years): 41
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the effectiveness of muscle energy technique along conventional physical therapy after mesenchymal stem cell transplantation in knee Osteoarthritis patients regarding Pain, range of motion, functional disability and quality of life.

Detailed description: Mesenchymal stem cells (MSCs) replacement is a regenerative therapeutic procedures for the early treatment of cartilaginous defects in knee osteoarthritis. MSCs may improve symptoms and function in osteoarthritic joints but also decrease inflammation and induce cartilage healing by differentiating into chondrocytes, osteoblasts and indicating appropriate extracellular matrix proteins (i.e. collagen I and II) through the secretion of cytokines, chemokines, and growth factors from MSCs.

Eligibility criteria: Inclusion Criteria:

* Both male and female
* Age \> 40 years
* Knee osteoarthritis patients undergone mesenchymal stem cell transplantation.

Exclusion Criteria:

* History of recent or past septic arthritis
* Patients with neurological deficit
* Uncontrolled diabetes
* Malignancy
* Vascular insufficiency

Primary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: NPRS used to measure changes from baseline pre and post 2 weeks physiotherapy session in knee OA patients after mesenchymal stem cell replacement and on 1 month follow up session.
Secondary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: WOMAC index used to measure changes from baseline pre and post 2 weeks physiotherapy session in knee OA patients after mesenchymal stem cell replacement and on 1 month follow up session.
measure: Goniometer (range of motion)
timeFrame: baseline pre and post 2 weeks physiotherapy session in knee OA patients after mesenchymal stem cell replacement and on 1 month follow up session.
measure: SF-12 (quality of life)
timeFrame: SF-12 used to measure changes from baseline pre and post 2 weeks physiotherapy session in knee OA patients after mesenchymal stem cell replacement and on 1 month follow up session.
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Institute of Regenerative medicine
Study officials:
affiliation: RIPHAH INTERNATIONAL UNIVERSITY,ISLAMABAD,PAKISTAN
name: KINZA ANWAR, MS-OMPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06016465: Does Nerve Block + Oral Dexamethasone Reduce Recurrence of Headache Within 72 Hrs?
Official title: Does Nerve Block Plus Oral Dexamethasone Reduce Recurrence of Headache Within 72 Hours Better Than Nerve Block Alone?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Migraine
Keywords: migraine headache
peripheral nerve block
dexamethasone
steroid treatment
Lead sponsor: Texas Tech University Health Sciences Center, El Paso
Sponsor class: OTHER
First posted: 2023-08-29
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized 1:1 for study drug vs placebo
Primary purpose: TREATMENT

Brief summary: For some patients who come to the emergency department for treatment of a migraine headache, peripheral headache nerve blocks (PHNB) have proven to be an efficient and effective treatment for headache relief. Previous studies have demonstrated that adding steroids as an adjunct treatment to standard migraine treatment can reduce recurrence of headaches in the subsequent few days.

Detailed description: Previous studies have provided evidence that administering steroids in addition to standard migraine headache treatment in the emergency department may reduce the recurrence of the headache within 24-72 hours. The standard migraine treatments in previous studies have been varied and include 5-HT receptor agonists, dopamine antagonists, dihydroergotamine, NSAIDS, and opioid analgesics. The steroids added to the standard treatment have been prednisone and dexamethasone (both IV and oral).

This is the first study to examine the combination of peripheral nerve block as the primary treatment of migraine followed by oral dexamethasone to prevent recurrence.

Eligibility criteria: Inclusion Criteria:

* Meet ICHD-3 Migraine Headache Criteria
* Had a minimum 5-point reduction in headache intensity after nerve block(s) or post- block pain score of 0 to 2
* Nerve block performed with bupivacaine 0.5%

Exclusion Criteria:

* Head trauma
* Suspicion of secondary headache (i.e. stroke, known tumor, glaucoma)
* Headache in the setting of viral syndrome
* Chronically on steroids
* Known allergy to dexamethasone
* Unable to reach the patient by phone or text for follow-up
* Gestational diabetes or other uncontrolled diabetes
* Known to be immunocompromised

Primary outcomes:
measure: Recurrence of headache
timeFrame: 72-96 hours post treatment
Secondary outcomes:
measure: Early recurrence headache and timing
timeFrame: 72-96hrs post treatment
measure: side effects of dexamethasone identified if any
timeFrame: 72-96 hrs post treatment
Other outcomes:
Locations:
city: EL Paso
country: United States
facility: University Medical Center of El Paso
state: Texas
Study officials:
affiliation: Texas Tech University Health Sciences Center, Department of Emergency Medicine
name: Susan Watts, PhD.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04559165: Efficacy and Safety of Sericin and Chitosan Cream for Preventing and Limiting the Progressive of Pressure Sore
Official title: Efficacy and Safety of Sericin and Chitosan Cream for Preventing and Limiting the Progressive of Pressure Sore
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pressure Ulcer
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
Collaborators: name: Police General Hospital
First posted: 2020-09-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate efficacy and safety of sericin and chitosan cream for preventing and limiting the progressive of pressure sore in 20 patients


Eligibility criteria: Inclusion Criteria:

* Age more than 18 years old
* 2-digit Stirling Pressure Sore Severity Scale less than or equal to 2.4
* No chitosan, sericin, and dimethicone allergy
* Without skin diseases
* Without Autoimmune diseases
* Willingness to participate

Exclusion Criteria:

* Have uncontrolled diseases
* Have complication or adverse effects during the time of participation
* Cannot follow protocol
* Pregnancy or lactation
* Participate in other study

Primary outcomes:
measure: Pressure ulcer scale for healing
timeFrame: 21 days
Secondary outcomes:
measure: Erythema index
timeFrame: 21 days
measure: Melanin index
timeFrame: 21 days
measure: Transepidermal water loss
timeFrame: 21 days
measure: Moisture index
timeFrame: 21 days
measure: Adverse events
timeFrame: 21 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity
Study officials:
References:
Clinical trial NCT05583565: Effect of the Sensory Integration Approach on Balance and Motor Coordination in Children With Down Syndrome
Official title: Effect of the Sensory Integration Approach on Balance and Motor Coordination in Children With Down Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Down Syndrome
Keywords: trisomy 21, Neurodevelopmental disorder
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-10-17
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Down syndrome can be characterized by global mental and physical dysfunction or isolated gait, cognition, growth, or sensory disturbances. This study was conducted to investigate the effect of the sensory integration approach on improving balance and motor coordination in children with Down syndrome.

Detailed description: Thirty children were enrolled in this study and randomly assigned to two groups: Group A received (sensory integration therapy program and training in physical therapy) and received group B (physical therapy training program only). Motor coordination and balance were assessed before and after exercise for all children using Bruininks - Oseretsky Test of Motor Proficiency - 2nd Edition.

Eligibility criteria: Inclusion Criteria:

* children with Down syndrome
* the ages of five and ten years who can walk
* their IQ is more than 75%

Exclusion Criteria:

* they had a serious neurological disorder (epilepsy), orthopedic problems, upper or lower limb surgery, vision or hearing problems, use of medications that impair behavior or attention, and suffered from advanced intellectual disability

Primary outcomes:
measure: balance
timeFrame: 6 months
Secondary outcomes:
measure: coordination
timeFrame: 6 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: CairoU
Study officials:
References:
Clinical trial NCT01062165: Effect of Weight and/or Obesity on Caspofungin Drug Concentrations
Official title: Population Pharmacokinetic Analysis of Caspofungin in Overweight and Obese Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Fungal Infection
Keywords: Echinocandin
Obesity
Pharmacokinetics
Pharmacodynamics
Fungal infection
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
name: University of Texas Southwestern Medical Center
First posted: 2010-02-04
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This study will find how weight affects the dosing of a drug called caspofungin. Currently, the amount of caspofungin a patient receives is the same regardless of the patient's weight.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects, age 18 years of age or older, of all racial and ethnic origins. English and/or Spanish speaking volunteers are eligible to participate.

Exclusion Criteria:

* Pregnant or nursing or unwilling to use a reliable contraception method during the study. The effects of caspofungin on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of caspofungin, so that the pregnancy and post-partum state would be a confounding variable.
* Abnormal liver function tests: transaminases\>10 times upper limit of normal, Alkaline phosphatase\>5 times upper limit of normal, total bilirubin\>5 times upper limit of normal.
* History of allergies to echinocandins.
* Echinocandins are contraindicated for any reason.
* Volunteers unwilling to comply with study procedures.
* Suspected or documented systemic fungal infection.
* Concomitant use of rifamycins, tacrolimus, or cyclosporine

Primary outcomes:
measure: Total Clearance of Caspofungin
timeFrame: 0-72 hours (0, 1, 8, 16, 24, 48, and 72 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: Texas Tech University HSC
name: Ronald Hall, PharmD, MSCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hall RG 2nd, Swancutt MA, Meek C, Leff R, Gumbo T. Weight drives caspofungin pharmacokinetic variability in overweight and obese people: fractal power signatures beyond two-thirds or three-fourths. Antimicrob Agents Chemother. 2013 May;57(5):2259-64. doi: 10.1128/AAC.01490-12. Epub 2013 Mar 4.
Clinical trial NCT02152865: Clinical Trial of Lupeol for Mild-moderate Acne
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne
Keywords: medication
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-06-02
Enrollment: 25
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: For the chemical lupeol isolated from eggplant, we applied it to one side of face, and applied vehicle control to another side for 8 -weeks. The study was performed in a 8-week, randomized controlled, split face fashion. Investigators evaluated safety and efficacy during baseline, 2 weeks, 4weeks, and 8 weeks after beginning of study.


Eligibility criteria: Inclusion Criteria:

* Patients over the age 15 who were clinically diagnosed with mild to moderate acne vulgaris

Exclusion Criteria:

* ; known pregnancy or lactation, any medical illness that might influence the results of the study, a previous history of oral acne medication or surgical procedures including laser treatment within 6 month and topical medication within 4 weeks of study enrollment.

Primary outcomes:
measure: Acne lesion counts as a measure of efficacy
timeFrame: 8 weeks after beginning of applications
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 8 weeks after beggning of applications
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: