louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01398397: Medical Record Review of Hypohidrotic Ectodermal Dysplasia Clinical Phenotype
Official title: Medical Record Review of Hypohidrotic Ectodermal Dysplasia Clinical Phenotype
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypohidrotic Ectodermal Dysplasia
X-Linked Hypohidrotic Ectodermal Dysplasia
Keywords: HED
XLHED
X-linked Hypohidrotic Ectodermal Dysplasia (XLHED)
Lead sponsor: Edimer Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: National Foundation of Ectodermal Dysplasia
First posted: 2011-07-20
Enrollment: 11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will enroll up to fifty HED/XLHED affected individuals.

Brief summary: This study is being done to collect information about people who have or may have Hypohidrotic Ectodermal Dysplasia (HED) or X-linked Hypohidrotic Ectodermal Dysplasia (XLHED). This study will allow Edimer Pharmaceuticals to know more about HED/XLHED so that hopefully the investigators can develop a drug to treat this condition. In this study Edimer will retrospectively review and abstract (summarize) medical records of people that have or may have HED/XLHED in order to further understand the natural history and disease characteristics.


Eligibility criteria: Inclusion Criteria:

-Males or females with:

1. the clinical characteristics of HED, including at least two of the following characteristics: a history of decreased sweating;abnormal teeth (fewer permanent teeth, teeth are smaller than average and often have conical crowns);sparseness of scalp and body hair.

   -OR-
2. genetically confirmed HED or XLHED;

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Edimer Pharmaceuticals
state: Massachusetts
Study officials:
References:
Clinical trial NCT01859897: A Prospective Multicenter Study to Evaluate Usefulness of Cardio-Ankle Vascular Index in Japan
Official title: A Prospective Multicenter Study to Evaluate Usefulness of Cardio-Ankle Vascular Index in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Cardiovascular Death
Nonfatal Myocardial Infarction
Lead sponsor: Okayama University
Sponsor class: OTHER
Collaborators: name: Toho University
name: Ehime University Graduate School of Medicine
name: Dokkyo Medical University
name: Okayama University
First posted: 2013-05-22
Enrollment: 3026
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primiary care clinic and hospital

Brief summary: The objective of this five-year prospective observational follow-up study is to examine the additional benefits of using cardio-ankle vascular index (CAVI) as a predictive indicator of cardiovascular events in high-risk patients.


Eligibility criteria: Inclusion Criteria:

Patients between 40 and 74 years of age who have either of the following:

1. Type 2 diabetes mellitus
2. Metabolic syndrome
3. Grade I to III hypertension with the third layer of risk factors according to the guidelines for the management of hypertension japanese society of hypertension(JSH)2009
4. Chronic kidney disease(stage G3a or G3b) according ot the clinical Practice Guidebook for Diagnosis and Treatment of Chronic Kidney Disease 2012 in Japan
5. History of coronary artery disease or noncardiogenic cerebral infarction

Exclusion Criteria:

1. Under 40 years of age or over 74 years of age
2. An ankle-brachial index less than 0.9
3. Chronic atrial fibrillation
4. Current symptoms of heart failure(NYHA class III or IV) or left ventricular dysfunction (EF below 40%)
5. Malignancy
6. Chronic kidney disease(G4 or G5)according ot the clinical Practice Guidebook for Diagnosis and Treatment of Chronic Kidney Disease 2012 in Japan
7. chronic dialysis due to renal failure
8. Taking steroids/immunosuppressants
9. Hepatocirrhosis

Primary outcomes:
measure: major cardiac events
timeFrame: five years
Secondary outcomes:
measure: all cause mortality, cardiovascular events, and renaly dysfunction
timeFrame: five years
Other outcomes:
measure: Change in CAVI and cardiovascular events
timeFrame: 5 years
Locations:
city: Okayama
country: Japan
facility: Okayama University
Study officials:
affiliation: Kenkoin Clinic
name: Hajime Orimo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miyoshi T, Ito H, Shirai K, Horinaka S, Higaki J, Yamamura S, Saiki A, Takahashi M, Masaki M, Okura T, Kotani K, Kubozono T, Yoshioka R, Kihara H, Hasegawa K, Satoh-Asahara N, Orimo H; CAVI-J (Prospective Multicenter Study to Evaluate Usefulness of Cardio-Ankle Vascular Index in Japan) investigators *. Predictive Value of the Cardio-Ankle Vascular Index for Cardiovascular Events in Patients at Cardiovascular Risk. J Am Heart Assoc. 2021 Aug 17;10(16):e020103. doi: 10.1161/JAHA.120.020103. Epub 2021 Aug 7.
Clinical trial NCT00973297: A Targeted Falls Prevention Program in Rehabilitation In-Patients
Official title: A Targeted Falls Prevention Program in Rehabilitation In-Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Accidental Falls
Keywords: Falls
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2009-09-09
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Falls are a major complication in patients treated in rehabilitation departments, yet studies evaluating different interventions to reduce falls-risk are rare and inconclusive.

The aim of the present study is to evaluate the efficacy of a multidisciplinary fall-prevention program to reduce falls and injury in stroke patients treated in a rehabilitation department.

All stroke patients consecutively admitted to the department of rehabilitation at Hadassah-Hebrew University Medical Center for a period of one year will be eligible for inclusion. Upon receiving an informed consent subjects will be randomized to the intervention group or the control (convention care) group.

There are no exclusion criteria. The Intervention includes group education on risk of falling and safe mobility and transfers; physical therapy of balance training at the patients' bedside twice weekly and medical assessment of medication use (anxiolytics/hypnotics, neuroleptics, antihypertensives and other vasodilators), orthostatic hypotension, urinary frequency/incontinence, delirium and visual problems.

Intervention therapy will not be given as an extra time, rather at the same treatment time as the control group.

Primary outcomes are rate of falls and related injuries.


Eligibility criteria: Inclusion Criteria:

* All stroke patients admitted to rehabilitation

Exclusion Criteria:

* None

Primary outcomes:
measure: Rate of falls and fall-related injury
timeFrame: At one year
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Yoram Maaravi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01840397: Neuromarker S-100B as Diagnostic Tool
Official title: Elevated Levels of S-100B and Neuron-specific Enolase (NSE) in Spine Surgery: A Comparison of Serum Levels With Surgery for Long-bone Fractures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Injury
Keywords: S-100B
NSE
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2013-04-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with spine fractures undergoing spine surgery for fracture stabilization

Brief summary: The hypothesis of this study is to find evidence if there is an influence of spine surgery on the serum levels of two proteins secreted from neuronal cells.

Detailed description: The question, if there is an effect on the cerebrospinal system during spine surgery, which can be traced by monitoring serum levels of neuromarkers is not yet answered. This study has its background from other studies on patients with traumatic brain injury (TBI), in whom elevated serum levels of the two neuromarkers S-100B and NSE are associated with injury severity, neuronal damage, brain, tissue damage, and outcome. Patients undergoing spine surgery with or without pre-existing traumatic neurologic symptoms are planned to be the study cohort. Pre- and postoperatively the serum levels of S-100B and NSE are obtained and are statistically compared with patients undergoing other types of bone-related surgery.

Eligibility criteria: Inclusion Criteria:

* spine fracture

Exclusion Criteria:

* additional traumatic brain injury
* fractures of the long bones
* polytrauma
* severely injured patients

Primary outcomes:
measure: S-100B levels
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna, Department for Trauma Surgery
name: Harald Wolf, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cao F, Yang XF, Liu WG, Hu WW, Li G, Zheng XJ, Shen F, Zhao XQ, Lv ST. Elevation of neuron-specific enolase and S-100beta protein level in experimental acute spinal cord injury. J Clin Neurosci. 2008 May;15(5):541-4. doi: 10.1016/j.jocn.2007.05.014. Epub 2008 Mar 14.
citation: Marquardt G, Setzer M, Theisen A, Tews DS, Seifert V. Experimental subacute spinal cord compression: correlation of serial S100B and NSE serum measurements, histopathological changes, and outcome. Neurol Res. 2011 May;33(4):421-6. doi: 10.1179/1743132810Y.0000000005.
citation: Marquardt G, Setzer M, Szelenyi A, Seifert V, Gerlach R. Prognostic relevance of serial S100b and NSE serum measurements in patients with spinal intradural lesions. Neurol Res. 2009 Apr;31(3):265-9. doi: 10.1179/174313209X382287. Epub 2008 Nov 26.
Clinical trial NCT00207597: Joint Outcome Study
Official title: A Clinical Trial of Primary Prophylaxis Against Joint Disease in Children With Severe Hemophilia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia A
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
First posted: 2005-09-21
Enrollment: 64
Sex: MALE
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: NATURAL_HISTORY
Time perspective: PROSPECTIVE

Brief summary: This study examines the progression of joint disease in children with hemophilia assigned to either standard treatment or enhanced therapy.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with hemophilia A
* factor level less than 2%

Exclusion Criteria:

* More than 2 bleeds into the same joint

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Colorado, Denver
name: Marilyn J Manco-Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Warren BB, Jacobson L, Kempton C, Buchanan GR, Recht M, Brown D, Leissinger C, Shapiro AD, Abshire TC, Manco-Johnson MJ; Joint Outcome Study Group Investigators. Factor VIII prophylaxis effects outweigh other hemostasis contributors in predicting severe haemophilia A joint outcomes. Haemophilia. 2019 Sep;25(5):867-875. doi: 10.1111/hae.13778. Epub 2019 May 21.
citation: Manco-Johnson MJ, Abshire TC, Shapiro AD, Riske B, Hacker MR, Kilcoyne R, Ingram JD, Manco-Johnson ML, Funk S, Jacobson L, Valentino LA, Hoots WK, Buchanan GR, DiMichele D, Recht M, Brown D, Leissinger C, Bleak S, Cohen A, Mathew P, Matsunaga A, Medeiros D, Nugent D, Thomas GA, Thompson AA, McRedmond K, Soucie JM, Austin H, Evatt BL. Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophilia. N Engl J Med. 2007 Aug 9;357(6):535-44. doi: 10.1056/NEJMoa067659.
Clinical trial NCT03709797: Effectiveness of Dry Needling as a Treatment of Shoulder Myofascial Pain Syndrome in Spinal Cord Injury Patients
Official title: Effectiveness of Dry Needling as a Treatment of Shoulder Myofascial Pain Syndrome in Spinal Cord Injury Patients: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Myofascial Pain Syndrome
Shoulder Pain
Puncture
Keywords: Spinal Cord Injury
Shoulder Pain
Myofascial Pain Syndrome
Dry Needling
Lead sponsor: Universidad de León
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Shoulder pain in people with spinal cord injury is one of the most prevalent in acute and chronic patients because of weakness in shoulder periarticular muscles, and also because of overuse of these part of the body in assistive devices.

This study aims to evidence if dry needling (a physiotherapy technique) is also useful in patients with spinal cord injury, and how long it could hold out without or less pain.


Eligibility criteria: Inclusion Criteria:

* At least one year after Spinal Cord Injury (chronic patients).
* Spinal Cord Injury under C5-C6 spinal level with American Spinal Injury Association (ASIA) classification.
* Patients with shoulder pain and at least one active trigger point in infraspinatus muscle.

Exclusion Criteria:

* Be apprehensive to the needles (belonephobia).
* Immunosuppression.
* Drug instability.
* Other medical causes that, under medical prescription, dry needling in the shoulder are discouraged.

Primary outcomes:
measure: Disabilities of the Arm, Shoulder and Hand Spanish version (DASHe).
timeFrame: Change from baseline and one week later.
Secondary outcomes:
measure: Pressure Pain Thershold (algometry).
timeFrame: Change from baseline, immediately after intervention and one week later.
measure: McGill Pain Questionnaire (Spanish version).
timeFrame: Change from baseline and one week later.
measure: Visual Analog Scale (VAS)
timeFrame: Change from baseline and one week later.
measure: Shoulder Pain And Disability Index Spanish version (SPADIe).
timeFrame: Change from baseline and one week later.
measure: Range Of Movement (ROM)
timeFrame: Change from baseline, immediately after intervention and one week later.
Other outcomes:
Locations:
city: Burgos
country: Spain
facility: Sandra Palacios Alfonso
Study officials:
References:
Clinical trial NCT04509297: Resistance Training and Milk Supplementation
Official title: Effects of High-protein Milk Supplementation on Muscular Strength and Power, Body Composition, and Skeletal Muscle Regulatory Markers Following Heavy Resistance Training in Resistance-trained Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscular Hypertrophy
Keywords: Hypertrophy
body composition
milk
resistance training
Lead sponsor: Marymount University
Sponsor class: OTHER
Collaborators: name: University of Tehran
First posted: 2020-08-12
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Post-resistance training high protein milk supplementation may be a viable method to elicit muscular gains.

The investigators hypothesis is that high protein milk supplementation would improve skeletal regulatory markers, hormonal responses and body composition in resistance-trained men.

Detailed description: The aim of this investigation was to compare the effects of high protein milk supplementation (daily and after training sessions) during 6 weeks of resistance training on skeletal muscle regulatory markers, hormonal responses and body composition in resistance-trained men. Specific aims of the study are to:

To investigate the extent to which high protein milk supplementation will improve anabolic factors, lean body mass, fat mass and decrease catabolic markers after 6 weeks of resistance training in resistance-trained men.

Eligibility criteria: Inclusion Criteria:

* Aged 18-35 years of age
* Healthy Males
* Experienced at resistance training (at least 1 year of prior structured resistance training 3 x week).

Exclusion Criteria:

* smoking
* chronic alcohol consumption
* having any medical issues and diseases
* lactose intolerance
* the consumption of any dietary supplements (including vitamins or protein supplements) or medications for 6 months prior to participation

Primary outcomes:
measure: Circulatory Myokines levels
timeFrame: 6 weeks
measure: Circulatory hormone levels
timeFrame: 6 weeks
measure: Body composition
timeFrame: 6 weeks
Secondary outcomes:
measure: Muscular Strength
timeFrame: 6 weeks
measure: Muscular Power
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Arlington
country: United States
facility: Marymount University
state: Virginia
Study officials:
affiliation: Marymount University
name: Alexei Wong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01579097: Comparative Phase 3 Trial to Assess the Safety and Efficacy of Triple-chamber Parenteral Nutrition Formulation
Official title: A Randomized, Comparative Phase 3 Trial to Assess the Safety and Efficacy of Triple-Chamber Parenteral Nutrition Formulation (Oliclinomel N4)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nutrition Support
Keywords: (PN) Parenteral nutrition
oral/enteral not possible
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2012-04-17
Enrollment: 458
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess the safety and efficacy of Oliclinomel N4 compared to compounded ternary parenteral nutrition (PN) admixtures for the delivery of PN in hospitalized adults for whom oral or enteral nutrition is not possible, insufficient, or contraindicated.


Eligibility criteria: Inclusion Criteria:

* Inpatient but hospitalized \< 14 days prior to enrollment
* Requires PN because oral or enteral nutrition is not possible, insufficient, or contraindicated
* Has capability to complete at least 5 days of study treatment (i.e., PN)
* Has a useable peripheral vein for delivery of intravenous (IV) PN

Exclusion Criteria:

* Has a life expectancy of \< 6 days from initiation of study treatment, in the opinion of the Investigator
* Known hypersensitivity to the components of either of the investigational study treatments
* Use of prohibited medications (e.g. glucocorticosteroids or antitumor chemotherapeutic agents) within 30 days prior to enrollment
* Known serious clinically significant condition that would preclude participation in the study
* Known chronic active hepatitis, elevated liver function tests
* Known history of human immunodeficiency virus infection
* Known severe dyslipidemia, severe hyperglycemia,clinically significant abnormalities of plasma electrolytes
* Known pregnancy or lactation

Primary outcomes:
measure: Serum Prealbumin
timeFrame: Serum Prealbumin at Day 5
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai No. 6 Hospital
Study officials:
affiliation: Shanghai, China
name: Baxter Investigative Site
role: STUDY_DIRECTOR
affiliation: Shantou, China
name: Baxter Investigative Site
role: STUDY_DIRECTOR
affiliation: Haikou, China
name: Baxter Investigative Site
role: STUDY_DIRECTOR
affiliation: Jiangsu Province, China
name: Baxter Investigative Site
role: STUDY_DIRECTOR
affiliation: Beijing, China
name: Baxter Investigative Site
role: STUDY_DIRECTOR
affiliation: Changsha, China
name: Baxter Investigative Site
role: STUDY_DIRECTOR
affiliation: Hangzhou, China
name: Baxter Investigative Site
role: STUDY_DIRECTOR
affiliation: Nanning, China
name: Baxter Investigative Site
role: STUDY_DIRECTOR
affiliation: Shang dong Province, China
name: Baxter Investigative Site
role: STUDY_DIRECTOR
References:
Clinical trial NCT01485497: Evaluation of Obstructive Sleep Apnea With Long Range 3D Endoscopic Fourier Domain Optical Coherence Tomography (FDOCT)
Official title: Evaluation of Obstructive Sleep Apnea With Long Range 3D Endoscopic Fourier Domain Optical Coherence Tomography (FDOCT)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Sleep Apnea
Keywords: APNEA
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: VA Long Beach Healthcare System
name: Beckman Laser Institute University of California Irvine
First posted: 2011-12-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether the Optical coherence tomography (OCT) can image the structure and geometry of hollow organs of the upper airway in sleep disorder. The research can identify the obstruction sites that help the select the appropriate treatment for potential surgical candidates.

Detailed description: The National Commission on Sleep Disorders Research estimated that 18 million Americans suffer from obstructive sleep apnea (OSA) The majority of them are undiagnosed and untreated at this time.

The current diagnostic gold standard for OSA is in-laboratory, a full night polysomnography (PSG). However, PSG is unable to provide information on upper airway structure and anatomy, and cannot identify the obstruction sites. OSA can lead to severe health complications including hypertension, heart failure, memory impairment, motor vehicle and work accidents, decreased work productivity, and increased risk of death.

Eligibility criteria: Inclusion Criteria:

1. Male or Female age 18-65 years has no history of obstructive sleep apnea
2. Male or Female age 18-65 years has been diagnose of mild to moderate obstructive sleep apnea
3. Male or Female age 18-65 years has been diagnose severe obstructive sleep apnea

Exclusion Criteria:

1. Pregnant women.
2. Breastfeeding women.
3. Unable to understand or give consent to the study.
4. Currently taking drugs that are sensitive to light.
5. Currently taking routine anti-convulsion, sedative or antihistamine drugs.
6. Currently taking immuno-suppressive drug therapy.

Primary outcomes:
measure: obstructive upper airways in sleep disordered
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UCI Beckman Laser Institute
name: Jun Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References: