louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00316251: Application of Specific Frequencies to Stimulate the Spinocerebellar Tract in Subjects With Unilateral Dysafferentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Somatosensory Disorders
Keywords: Somatosensory dysfunction
Lead sponsor: Logan College of Chiropractic
Sponsor class: OTHER
First posted: 2006-04-20
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effects of Power Plate vibration therapy on balance as measured by the NeuroCom Balance Master.

Detailed description: Acute and chronic equilibrium disorders result in over five million patient visits per year in the United States with unknown additional individuals not seeking care. Symptoms of dizziness, vertigo, and lack of balance are among the most common symptoms reported to physicians. Equilibrium disorders not exclusively due to visual or vestibular conditions are typically due to problems in proprioception. Proprioception is the specialized sensory modality that informs the body as to movement, position, and spatial orientation through mechanisms that track sensations accompanying joint movement and position. Mechanoreceptors in joints, along with vestibular, visual, muscle spindle, Golgi tendon organ, ligament and tendon sensory receptors, comprise the propriosensory system, which conveys information to the motor system to maintain equilibrium on a reflexive, automatic basis. Alterations in somatosensory input from mechanoreceptors have been identified as causing aberrant muscle firing patterns.

The NeuroCom Balance Master is an FDA approved device designed to both measure and treat balance problems and evaluate the neuromuscular control by quantifying the ability to maintain dynamic postural stability. The NeuroCom Unit is a microprocessor controlled balance unit that provides quantitative data regarding the patient's ability to control the platform. This unit is widely used throughout the country in both university and clinical settings to help patients restore their balance.

Eligibility criteria: Inclusion Criteria:

* Logan student, staff, or faculty with no history of ankle injury
* Ages 18 - 60 years old
* Logan student, staff, or faculty with no history of ankle surgery
* No visual or vestibular condition that would affect balance

Exclusion Criteria:

* Systemic illnesses that have an adverse effect on balance
* Local infection, injury, or other malignancy affecting the lower extremity
* Any unstable joints of the lower extremity
* Any spinal manipulation within 48 hours
* Prescription or herbal muscle stimulants, relaxants, etc. that could affect balance
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chesterfield
country: United States
facility: Logan College of Chiropractic
state: Missouri
Study officials:
affiliation: Logan College of Chiropractic
name: Dennis E. Enix, DC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03072251: Participation of Breast Milk Feeding Mothers in Research
Official title: Participation of Breast Milk Feeding Mothers in Research
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breastfeeding
Energy Intake
eHealth
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2017-03-07
Enrollment: 570
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from the community via print, electronic, and social media. Any individual may take the survey.

Brief summary: To assess concerns and barriers for measuring milk intake of breast fed infants using the remote food photography method and SmartIntake smartphone application. These data will 1) provide support for further development of the Infant RFPM and 2) provide important preliminary data in a National Institutes of Health grant application being developed and assess the prevalence of exclusive breastfeeding and complementary breastfeeding in the study population.

Detailed description: Study participation will be the completion of an anonymous, online survey powered by HIPAA compliant REDCap database. The survey will be made available to potential participants through the internet. The survey will take approximately five minutes to complete. The expected duration of recruitment and completion of the study is six months.

Eligibility criteria: Inclusion Criteria:

* Any individual may take the survey.

Exclusion Criteria:

* None

Primary outcomes:
measure: Receptivity for measuring milk intake for 5-7 days using a smartphone app
timeFrame: 1 day
Secondary outcomes:
measure: Receptivity for expressing human breast milk to assess milk intake for 5-7 days
timeFrame: 1 day
Other outcomes:
measure: Prevalence of breastfeeding in the survey population (exclusive, in combination with infant formula, in combination with other foods)
timeFrame: 1 day
measure: Method of feeding (breast, expressed human milk in an infant feeding bottle, combination of feeding methods)
timeFrame: 1 day
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Leanne Redman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02097251: An Open-Label Treatment Protocol With UX003 rhGUS Enzyme Replacement Therapy for an Advanced Stage MPS 7 Patient
Official title: An Open-Label Treatment Protocol With UX003 Recombinant Human Beta-glucuronidase (rhGUS) Enzyme Replacement Therapy for an Advanced Stage Mucopolysaccharidosis Type 7 (MPS 7) Patient
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Mucopolysaccharidosis Type 7
Keywords: Mucopolysaccharidosis Type 7
Sly syndrome
UX003
Enzyme Replacement Therapy
rare disease
Lysosomal Storage Disease
metabolic disorder
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Ultragenyx Pharmaceutical Inc
First posted: 2014-03-27
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Emergency access granted to treat a single patient with advanced Mucopolysaccharidosis Type 7 with UX003 Recombinant Human Beta-glucuronidase (rhGUS) Enzyme Replacement Therapy via IV administration every other week (QOW) for up to 144 weeks.


Eligibility criteria: Inclusion Criteria:

* 1 specific patient
* Confirmed diagnosis of MPS 7 based on leukocyte or fibroblast glucuronidase enzyme assay or genetic testing confirming diagnosis.
* Written informed consent of parent(s) or legal guardian(s)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: Cohen Children's Medical Center
state: New York
Study officials:
References:
Clinical trial NCT01085851: Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Lotion) in the Relief of Sunburn Related Symptoms
Official title: Non-inferiority, Monocentric Comparative Open Study of Two Topical Pharmaceutical Preparations (Cream and Lotion) of Dexchlorpheniramine Maleate in the Evaluation of Safety and Efficacy for the Relief of Sunburn Related Symptoms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Sunburn
Keywords: Sunburn
Dexchlorpheniramine
Lotion
Cream
Lead sponsor: Mantecorp Industria Quimica e Farmaceutica Ltd.
Sponsor class: INDUSTRY
First posted: 2010-03-12
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Topical antihistamines can be used to promote relief of sunburn related symptoms (erythema, itch and burning sensations). Dexchlorpheniramine maleate 1% cream is a topical antihistamine formulation approved by ANVISA in Brazil for the relief of skin irritation and pruritus, including the ones caused by sunburn. The aim of the present study is to demonstrate non-inferiority of a new pharmacological preparation of dexchlorpheniramine maleate (1% lotion) with the standard preparation (1% cream) for the relief of sunburn related symptoms and to demonstrate the safety of both preparations.


Eligibility criteria: Inclusion Criteria:

* Signs of solar erythema of mild to moderate intensity resulting from voluntary exposure to sun within the last 72 hours
* Presence of lesions with some degree of symmetry to allow comparison between both pharmaceutical formulations
* Compliance of the subject to the treatment protocol
* Agreement with the terms of the informed consent by the participants or their legal guardians when younger than 18 years old

Exclusion Criteria:

* Pregnancy or risk of pregnancy
* Lactation
* Signs of solar erythema of severe intensity
* Use of topical or systemic anti-inflammatory, antihistamine or immunosuppressive drugs within the last 48 hours prior to the study
* History of atopy or allergic diseases
* History of allergy to any component of the formulations
* Other conditions considered by the investigator as reasonable for non-eligibility

Primary outcomes:
measure: Pruritus intensity evaluated with a 10-point Visual Analogic Scale (VAS)
timeFrame: 7 days
Secondary outcomes:
measure: Composite clinical evaluation of erythema, pruritus and burning sensation performed by the investigator using a 4-point scale for each one of the variables (absent, mild, moderate, intense).
timeFrame: 7 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Medcin Instituto da Pele Ltda
state: SP
Study officials:
affiliation: Medcin Instituto da Pele Ltda
name: Sérgio Schalka, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05014451: Pelvic Alignment in Relation to Standing Balance and Selective Motor Control in Children With Spastic Diplegia
Official title: Pelvic Alignment in Relation to Standing Balance and Selective Motor Control in Children With Spastic Diplegia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Palsy
Spastic Diplegia
Keywords: pelvic alignment
pelvic tilt, torsion, inclination
Formetric
Biodex
dynamic balance
selective motor control
SCALE
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-08-20
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with spastic diplegia, their height will not be less than 1 meter to meet the requirements of assessment by the Biodex and Formetric systems. They will be able to stand without the use of an assistive device and they will be able to follow instructions and understand given orders.

Brief summary: This study will be conducted to identify the relation between pelvic alignment and standing balance and also the relation between pelvic alignment and selective motor control in children with spastic diplegic cerebral palsy.

Detailed description: In this study, pelvic alignment of children with diplegia will be evaluated using the Formetric instrument system. Their standing balance will be evaluated using the Biodex balance system, while selective voluntary motor control of lower extremities will be assessed using the Selective Control Assessment of the Lower Extremity scale (SCALE).

Results will be compared to find the correlation between pelvic alignment and standing balance and the correlation between pelvic alignment and selective motor control. Results can help clinicians to better address the problems of pelvic asymmetry in children with spastic diplegia to improve their overall balance and functional abilities.

Eligibility criteria: Forty children with spastic diplegia of both sexes will be selected with the following criteria:

Inclusion Criteria:

1. Their age will be ranged from 6 to 8 years.
2. The degree of their spasticity will be ranged from 1 to 1+ according to Modified Ashworth' Scale.
3. They will be on level Ⅰ or Ⅱ on Growth Motor Function Classification System (GMFCS).

Exclusion Criteria:

The Children will be excluded if they have one of the following:

1. Severe visual or hearing impairment.
2. Fixed deformities or surgical interventions in the lower extremities.
3. Botulinum toxin injections in the last 6 months.

Primary outcomes:
measure: Pelvic alignment in relation to dynamic standing balance
timeFrame: 2 months
measure: Pelvic alignment in relation to selective voluntary motor control of the lower extremities
timeFrame: 2 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00412451: A Multicenter Study to Compare Multiple Doses of Intravitreal Microplasmin Versus Sham Injection for Treatment of Patients With Diabetic Macular Edema (DME)
Official title: A Randomized, Sham-Injection Controlled, Double-Masked, Ascending-Dose, Dose-Range-Finding Trial of Microplasmin Intravitreal Injection for Non-Surgical Posterior Vitreous Detachment (PVD) Induction for Treatment of DME.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Macular Edema
Keywords: Diabetic Macular Edema
PVD
DME
Diabetic Retinopathy
Lead sponsor: ThromboGenics
Sponsor class: INDUSTRY
First posted: 2006-12-18
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with DME.


Eligibility criteria: Inclusion Criteria include:

* patients \>18 years of age with Diabetic Macular Edema

Exclusion Criteria include:

* PVD present at baseline
* Vitreous hemorrhage
* Certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR)
* Patients who have had a vitrectomy in the study eye at any time

Primary outcomes:
measure: PVD Induction
timeFrame: Day 14 post-injection
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: ZNA OCMW Antwerpen
city: Ghent
country: Belgium
facility: University Hospital of Ghent
city: Leuven
country: Belgium
facility: University Hospital Leuven
city: Munich
country: Germany
facility: Ludwig Maximillian University
city: Milan
country: Italy
facility: University of Milan
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana
city: Rome
country: Italy
facility: Institute of Ophtalmology, Policlinico A: Gemelli (University Hospital),Catholic University of Sacred Heart
city: Varese
country: Italy
facility: Ospedale di Circolo di Varese, Insubria University
city: Groningen
country: Netherlands
facility: Academic Hospital Groningen
city: Rotterdam
country: Netherlands
facility: Het Oogziekenhuis Rotterdam
city: Barcelona
country: Spain
facility: Institut de Microcirurgia Ocular de Barcelona
city: Barcelona
country: Spain
facility: Hospital Vall D'Hebron
city: Santiago de Compostela
country: Spain
facility: Instituto Technologico de Oftalmologia SL.
city: Liverpool
country: United Kingdom
facility: Royal Liverpool & Broadgreen Hospital
city: London
country: United Kingdom
facility: Moorfields Eye Hospital
Study officials:
References:
Clinical trial NCT00619151: CarboMedics Top Hat vs St. Jude Medical Regent Valve Comparing Sizing and Hemodynamics
Official title: A Randomized Study to Compare Sizing, Implant Techniques, & Hemodynamic Performance Between the CarboMedics Supra-annular Top Hat Valve and the St. Jude Medical Regent Valve in the Aortic Position.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aortic Valve Disease
Keywords: aortic valve
heart valve
valve replacement
Valve disease
Lead sponsor: Sorin Group USA, Inc.
Sponsor class: INDUSTRY
First posted: 2008-02-20
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to compare the sizing and implant techniques between the CarboMedics Top Hat supra-annular valve and the St. Jude Medical Regent valve.


Eligibility criteria: Inclusion Criteria:

* Patients who are indicated for implant with a mechanical valve prosthesis in the aortic position according to the current practice for valve selection at the center.

Exclusion Criteria:

* Patients \< 18 years of age
* Emergency surgery
* Pre-existing valve prosthesis
* Aortic root replacement
* Active endocarditis

Primary outcomes:
measure: Effective Orifice Area (EOA)
timeFrame: 6 month evaluation
measure: Aortic Mean Gradient
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Kingsport
country: United States
facility: Wellmont Holston Valley Medical Center
state: Tennessee
Study officials:
References:
Clinical trial NCT04278651: Early Antenatal Support for Iron Deficiency Anemia
Official title: Early Antenatal Support for Iron Deficiency Anemia: A Randomized Controlled Trial of Early Initiation of Intravenous Versus Oral Iron Therapy for Treatment of Iron Deficiency Anemia in Pregnancy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Pregnancy Related
Anemia, Iron Deficiency
Anemia of Pregnancy
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Auerbach Hematology and Oncology
First posted: 2020-02-20
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: This is a randomized, controlled multi-site trial of iron therapy in pregnancy. The purpose of this research is to see if second trimester initiation of intravenous (IV) iron therapy is better than oral iron therapy for treatment of anemia in pregnancy by improving blood count, quality of life and reducing side effects.

Detailed description: Pregnant singletons diagnosed with iron deficiency anemia will be enrolled between 14-24 weeks and will be randomized 1:1 to either a course of ferumoxytol (510mg x 2 doses 3-8 days apart) or oral iron (325mg) twice daily.

Eligibility criteria: Inclusion Criteria:

* Singleton gestation
* Gestational age \<24 weeks
* Baseline Hb ≥9.0 and \<11.0 with evidence of iron deficiency anemia

Iron deficiency anemia diagnosed (at any point in patient history) by:

* Hb\<11.0
* Ferritin\<30 and/or total iron saturation \<20

Exclusion Criteria:

* Sickle cell Disease (NOT sickle cell trait)
* Evidence of acute anemia requiring transfusion or IV iron therapy
* Major congenital or chromosomal anomaly
* Previous use of IV iron in this pregnancy
* Severe cardiac, renal, or liver disease
* Autoimmune disease (ie Systemic Lupus Erythematosus (SLE)
* Allergy or contraindication to either study drug
* History of medication allergy, reaction to IV infusion, or reaction to Feraheme or other IV iron products

Primary outcomes:
measure: Change in Hemoglobin
timeFrame: 90 days
Secondary outcomes:
measure: Anemia resolution
timeFrame: 90 days
measure: Anemia at Delivery
timeFrame: 9 months
measure: Need for additional therapy
timeFrame: 9 months
measure: Quality of life scale
timeFrame: 30, 60, 90 days
measure: Adherence
timeFrame: 90 days
measure: Need for post partum transfusion
timeFrame: 9 months
measure: Neonatal outcomes: cord blood iron indices
timeFrame: 9 months
measure: Neonatal outcomes: birth weight
timeFrame: 9 months
measure: Neonatal outcomes gestational age of delivery (weeks)
timeFrame: 9 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
References:
Clinical trial NCT04707651: Formula Diet Treatment for NASH Patients.
Official title: Formula Diet Treatment for Weight Reduction in NASH Patients.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Steatohepatitis, Nonalcoholic
Keywords: overweight
fatty liver
Lead sponsor: West German Center of Diabetes and Health
Sponsor class: OTHER
First posted: 2021-01-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Lifestyle intervention including formula diet
Primary purpose: TREATMENT

Brief summary: Non-alcoholic steatohepatitis (NASH) - also called fatty liver - is medically a serious problem because the liver tissue becomes fatty and stiff, and inflammatory reactions occur. This increases the risk of liver fibrosis (= scarring of the liver), liver cirrhosis (= shrunken liver), a liver tumor or death. So far there is no recognized treatment option for this disease. However, there is evidence that a lifestyle change based on a reduced carbohydrate diet, more exercise and a significant weight loss that can improve NASH.

Detailed description: Outpatients with NASH will be included into this lifestyle intervention study. Patients will get nutritional advices and a formula diet for 12 weeks. Clinical visits will take place at baseline, after 4, 12 and after 52 weeks.

Eligibility criteria: Inclusion Criteria:

* BMI\>25 kg/qm

Exclusion Criteria:

* history of drug or alcohol abuse
* acute or chronic diseases (except type 2 diabetes)
* pregnancy or breast feeding

Primary outcomes:
measure: degree of steatosis
timeFrame: 12 weeks
Secondary outcomes:
measure: degree of steatosis
timeFrame: 52 weeks
measure: degree of fibrosis
timeFrame: 12 weeks and 52 weeks
measure: fat mass
timeFrame: 12 weeks and 52 weeks
measure: Glutamate Pyruvate Transaminase (GPT)
timeFrame: 12 weeks and 52 weeks
measure: Gamma-glutamyltransferase (GGT)
timeFrame: 12 weeks and 52 weeks
measure: insulin
timeFrame: 12 weeks and 52 weeks
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Düsseldorf Catholic Hospital Group
city: Wuppertal
country: Germany
facility: Praxis Prof. Erhardt
Study officials:
affiliation: West-German Centre of Diabetes and Health
name: Stephan Martin, MD
role: PRINCIPAL_INVESTIGATOR
References: