louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00001342: Study of Glycogen Storage Disease and Associated Disorders
Official title: A Study of Collateral Disorders of Glycogen Storage Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glycogen Storage Disease
Keywords: Electrooculography
Electroretinogram
Fluorescein Angiogram
Glycogen Storage Disease
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2002-12-10
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Glycogen, is the storage form of glucose. It is usually formed from sugar and stored in the liver. When tissues, such as muscle, need glucose for fuel the stored glycogen is converted into glucose with the help of enzymes produced in the body. Glycogen storage disease (GSD) refers to a group of conditions characterized by abnormal storage of glycogen due to the absence of particular enzymes needed in the process of storing and using glycogen.

This study addresses the related metabolic abnormalities of glycogen storage disease (GSD). As patients with disorders of glycogen metabolism are followed it becomes apparent that the condition is much more complex than initially thought.

Researchers believe that patients suffering from glycogen storage disorders should be followed and monitored for other heritable metabolic disorders.

This study will attempt to determine the frequency of associated disorders in patients with GSD. In addition, the study will look at the current management of these patients to see if the prognosis and course of the disease is changed.

Detailed description: This study addresses the related metabolic abnormalities of the glycogeneses. As more older individuals with glycogen storage disease are followed and studied, it becomes apparent that when individuals with glycogenosis are viewed from a longitudinal perspective, the condition is much more complex and diverse in its related conditions than one would have reason to believe, even in hindsight. It is relevant to follow these individuals, searching for abnormalities not only with glycogen storage disease in mind, but also because other heritable metabolic disorders, including cystinosis and cystic fibrosis, reflect the accumulation of associated disorders with age which often have no apparent direct association with GSD.

Eligibility criteria: Patients age 20 or older, male or female.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institute of Child Health and Human Development (NICHD)
state: Maryland
Study officials:
References:
citation: Chen YT, Coleman RA, Scheinman JI, Kolbeck PC, Sidbury JB. Renal disease in type I glycogen storage disease. N Engl J Med. 1988 Jan 7;318(1):7-11. doi: 10.1056/NEJM198801073180102.
citation: Goans RE, Weiss GH, Vieira NE, Sidbury JB, Abrams SA, Yergey AL. Calcium kinetics in glycogen storage disease type 1a. Calcif Tissue Int. 1996 Dec;59(6):449-53. doi: 10.1007/BF00369209.
Clinical trial NCT00528242: Safety, Tolerability, and Pharmacodynamic Profile of Oral 2101 in Secondary Raynaud's Disease
Official title: A Randomized, Double Blind, Placebo-controlled, Cross-over Pilot Study to Examine the Safety, Tolerability and Pharmacodynamic Profile of Repeat Oral Doses of SLx-2101 Once Daily for up to 14 Days in Subjects With Secondary Raynaud's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Raynaud's Disease
Lead sponsor: Response Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-09-12
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To investigate the severity of secondary Raynaud's disease-related attacks during the 14 days 2101 dosing period.

Detailed description: 1. Number and cumulative duration of Raynaud's attacks.
2. Adverse events and changes in vital signs.
3. SLx-2101 pharmacokinetic parameters derived after dosing on Day 1 and Day maximum plasma concentration (Cmax), area under the plasma concentration-time curve (AUC0-4), time to Cmax (tmax), and accumulation ratio

Eligibility criteria: Inclusion Criteria:

* male and female ages 18 and 65 y.o.
* BMI Body weight within a body mass index range of 17 - 30 kg/m2 (inclusive).

Exclusion Criteria:

* Hypersensitivity to the active substance of SLx-2101or to any of the excipients.
* Past or present disease that is judged by the Investigator to have the potential to interfere with the study procedures, compromise safety, or affect the pharmacokinetic and pharmacodynamic evaluations

Primary outcomes:
measure: Raynaud's condition scores after 14 days of SLx-2101
timeFrame: 14 days
Secondary outcomes:
measure: Safety and tolerability
timeFrame: 14 days
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: University des Saarlandes
Study officials:
affiliation: University des Saarlandes
name: M Baumaker, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02727842: Usability of the CP950 Sound Processor
Official title: Usability of the CP950 Sound Processor With Experienced Cochlear Implant Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: cochlear implant
Sound Processor
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
First posted: 2016-04-05
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Studying usability and gaining feedback of the CP950 Sound Processor in experienced cochlear implant recipients.

Detailed description: One month protocol, with 2 study visits. The aim of the study to is to gain patient and audiologist feedback on their experience and usability with the device and wireless programming pod.

Eligibility criteria: Inclusion Criteria:

1. At least 6 months experience with a Nucleus 24 series or later implant in at least one implanted ear
2. Subjects age 12 and older who are cognitively and developmentally able to complete all study related questionnaires as deemed by the principal investigator or delegated staff
3. At least 3 months experience with the CP810,CP920 or CP910 sound processor
4. Ability to use 2 zinc air batteries with their current program (MAP)
5. Willingness to participate in and to comply with all requirements of the protocol for the duration of the trial

Exclusion criteria:

1. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device
2. Additional disabilities that would prevent participation in evaluations
3. Implant types not currently supported by the CP950 sound processor (i.e.,N22)

Primary outcomes:
measure: Patient Satisfaction Through Usability of the CP950 Sound Processor as Measured by the CP950 Take Home Questionnaire
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Rocky Mountain Ear Center
state: Colorado
city: New York
country: United States
facility: NYU
state: New York
city: Oklahoma City
country: United States
facility: Hearts for Hearing
state: Oklahoma
Study officials:
References:
Clinical trial NCT01951742: Dose Finding Study In Subjects With Crow's Feet
Official title: Dose Finding Study of Botulinum Neurotoxin Type A In Subjects With Crow's Feet (Lateral Canthal Lines)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lateral Canthal Lines
Crow's Feet
Keywords: wrinkles
Lead sponsor: Anterios Inc.
Sponsor class: INDUSTRY
First posted: 2013-09-27
Enrollment: 145
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to establish the therapeutic range of ANT-1401 in the treatment of Crow's Feet.


Eligibility criteria: Inclusion Criteria:

* 30 - 60 years of age
* mild to moderate Crow's Feet wrinkles at rest
* moderate to severe Crow's Feet wrinkles on contraction
* willingness to refrain from any product affecting skin remodeling
* female subjects must be not pregnant and non-lactating

Exclusion Criteria:

* history of peri-ocular surgery, brow lift or related procedures
* procedures affecting the lateral canthal region in the prior 12 months
* application of topical prescription medication to the treatment area
* female subjects who are pregnant or are nursing a child

Primary outcomes:
measure: Investigators Global Assessment Scale
timeFrame: Week 4
Secondary outcomes:
measure: Subject Self-Assessment score
timeFrame: up to 12 12 weeks
Other outcomes:
Locations:
city: Miami
country: United States
state: Florida
city: Pinellas Park
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Metairie
country: United States
state: Louisiana
city: New Orleans
country: United States
state: Louisiana
city: Rochester
country: United States
state: New York
city: High Point
country: United States
state: North Carolina
city: Knoxville
country: United States
state: Tennessee
city: Norfolk
country: United States
state: Virginia
Study officials:
References:
Clinical trial NCT03877042: The Efficacy of Using CR and PS Prosthesis in Total Knee Replacement
Official title: The Efficacy of Using CR and PS Prosthesis in Total Knee Replacement: a Randomized, Double-blind, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Total Knee Arthroplasty
Keywords: Total Knee Arthroplasty
CR
PS
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 100
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: TREATMENT

Brief summary: The investigators will investigate the efficacy of using CR and PS implants in TKA. The investigators will conduct TKA with different implants simultaneously on one patient to compare the post-operation efficacy of both implants.

Detailed description: A randomized, single-center, single group study comparing the efficacy and safety of using CR and PS implants in TKA. The investigators will conduct TKA with different implants simultaneously on one patient to compare the post-operation efficacy of both implants. Subjects will be monitored through postoperative follow-up to understand the bilateral knee condition.

Eligibility criteria: Inclusion Criteria:

* Adult patients who plan to undergo primary total knee arthroplasty on bilateral knee joint with a diagnosis of osteoarthritis or rheumatoid arthritis, etc.;

Exclusion Criteria:

* Those who do not meet the inclusion criteria;
* Neuromuscular dysfunction;
* Diseases affecting postoperative efficacy evaluation

Primary outcomes:
measure: HSS score changes after TKA
timeFrame: 1,3,6,12 months after TKA
measure: KSS score changes after TKA
timeFrame: 1,3,6,12 months after TKA
measure: X-ray evaluation changes after TKA
timeFrame: 1,3,6,12 months after TKA
measure: Muscle strength measurement changes after TKA
timeFrame: 1,3,6,12 months after TKA
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
Study officials:
affiliation: Air Force Military Medical University, China
name: Qingsheng Zhu, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00952042: Resistance Training as Treatment of Achilles Tendinopathy
Official title: Heavy Slow Resistance Versus Eccentric Training in the Treatment of Achilles Tendinopathy. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Achilles Tendinopathy
Keywords: Tendinopathy, Achilles, Eccentric training, Heavy slow resistance training
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2009-08-04
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The use of eccentric resistance training as management of Achilles tendinopathy is widespread. The investigators have recently demonstrated that heavy slow resistance training was superior in the management of patellar tendinopathy.

Hypothesis: heavy slow resistance training is more effective than eccentric resistance training in the clinical management of Achilles tendinopathy.


Eligibility criteria: Inclusion Criteria:

* Unilateral Achilles tendon pain,
* Symptoms for at least three months,
* Ultrasonographical tendon abnormalities, AND
* Able to comply with both intervention arms.

Exclusion Criteria:

* Bilateral symptoms,
* Previous surgery below knee,
* Corticosteroid injections below the knee during past year,
* Hypercholesterol,
* Diabetes, OR
* Arthritis.

Primary outcomes:
measure: VISA-A score
timeFrame: 0,12 wks + 1yr follow-up
Secondary outcomes:
measure: Tendon thickness
timeFrame: 0,12 wks + 1yr follow-up
Other outcomes:
Locations:
city: Copenhagen NV
country: Denmark
facility: Institute of Sports Medicine Copenhagen. Bispebjerg Hospital
Study officials:
affiliation: Institute of Sports Medicine Copenhagen (www.ismc.dk)
name: Rikke Beyer, PhD. stud
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04597242: Expanded Access Study of Exebacase in COVID-19 Patients With Persistent MRSA Bacteremia
Official title: Expanded Access Study of a Single Dose of Exebacase in Addition to Antistaphylococcal Antibiotics for the Treatment of Persistent Methicillin-Resistant Staphylococcus Aureus (MRSA) Bloodstream Infections (Including Right Sided Endocarditis) in Patients Who Are Hospitalized With Coronavirus Disease 2019 (COVID-19)
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: MRSA Bloodstream Infection
MRSA Bacteremia
MRSA Right-sided Endocarditis
Covid19
Lead sponsor: ContraFect
Sponsor class: INDUSTRY
First posted: 2020-10-22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This is an open-label, expanded access study of exebacase used in addition to antistaphylococcal antibiotics in adult patients with persistent methicillin-resistant Staphylococcus aureus (MRSA) bloodstream infections (BSI), including right-sided endocarditis (R-IE), who are hospitalized with coronavirus disease 2019 (COVID-19). Patients with left-sided endocarditis (L-IE) are excluded. Patients will receive a single dose of exebacase. Patients will continue to receive antistaphylococcal antibiotics as prescribed by the treating physician. Exebacase Phase 3 study sites (Study CF-301-105) may participate in this Expanded Access study (Study CF-301-107).

Exebacase, a direct lytic agent, is an entirely new treatment modality against S. aureus. Exebacase is a recombinantly-produced, purified cell wall hydrolase enzyme that results in rapid bacteriolysis, potent biofilm eradication, synergy with antibiotics, low propensity for resistance, and the potential to suppress antibiotic resistance when used together with antibiotics. Exebacase represents a first-in-field, first-in-class treatment with the potential to improve clinical outcome when used in addition to standard-of-care antibiotics to treat S. aureus BSI including IE.


Eligibility criteria: Inclusion Criteria:

* Male or female, 18 years of age or older.
* Hospitalized with known COVID-19 infection confirmed by positive diagnostic test.
* Not eligible for the exebacase Phase 3 study (CF-301-105).
* Blood cultures positive for MRSA for ≥3 days.
* Patient is not pregnant or breastfeeding and is not of reproductive potential or agrees to remain abstinent or use contraception if of reproductive potential.

Exclusion Criteria:

* Known or suspected left-sided IE.
* Intubated for COVID-19.
* Presence of prosthetic valve or cardiac valve support ring, or presence of known infected orthopedic hardware, prosthetic joint, or cardiac device.
* Known or suspected brain abscess or meningitis.
* Participation in an investigational study or expanded access protocol for another antistaphylococcal antibacterial agent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Butte
country: United States
facility: CF-301-107 Study Site
state: Montana
city: Toledo
country: United States
facility: Cf 301-107
state: Ohio
Study officials:
References:
Clinical trial NCT04321642: The Effect of Entonox on Stages of Labor in Nulliparous Women
Official title: The Effect of Entonox on Stages of Labor in Nulliparous Women :a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ENTONOX
Nulliparous
Duration of Labor
Keywords: Entonox
Nulliiparous
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2020-03-25
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Trial study about The effect of Entonox associated with duration of labor in Active phase and efficacy for relief pain of labor .So investigators start to study up to 14 months

Detailed description: Investigators will enroll participants in 2 groups by randomized . First group will inhale Entonox and the second group not receive any gas . The participants in Entonox group will inhale gas in 4-5 times for each uterine contraction and Nurse will measure blood pressure , O2 saturation ,pain score before use gas . The outcome,investigators study about Apgar score , duration of labor , pain relief in both group,route of delivery and estimated blood loss

Eligibility criteria: Inclusion Criteria:

* Nulliparity
* Age 18 years old or more
* Gestational age 37-40+6 wks
* Singleton
* Cephalic presentation
* Cervical dilatation \> 5 cm
* Estimated fetal weight 2,500-4,000 gm

Exclusion Criteria:

* Estimated fetal weight more than 4,000 gm
* High risk pregnancy (Hypertension in pregnancy ,Endocrine disorder , autoimmune disorder , epilsepsy etc)
* SpO2 \< 95 %
* Contraindication for Entonox usage ( Severe head injury , asthma , Pulmonary disease,Otitis media )
* Drug allergy : Metoclopramide , Dimenhydrinate , Pethidine ,Entonox

Primary outcomes:
measure: Effect of Entonox for duration of labor
timeFrame: up to 14 months
Secondary outcomes:
measure: Rate of patients who inhaled Entonox for pain relieve
timeFrame: up to 14 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
Study officials:
affiliation: Department of Medical Services Ministry of Public Health of Thailand
name: Somboon sornsukulrat, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01845142: Immunologic Action of a Single Dose Cholecalciferol
Official title: Immunologic Functions of a Single Dose of 100.000 I.U. Cholecalciferol (Vitamin D3)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vitamin D Deficiency
Keywords: vitamin D
vitamin D deficiency
immune cells
pharmacokinetic
< 50 nmol/L 25(OH)D serum concentration
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2013-05-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Vitamin D receptors are expressed in activated different immune cells. It is not known, which immune cell type is targeted by exogenous vitamin D. Here, vitamin D-deficient individuals will receive once 100.000 I.U. vitamin D3 either intramuscular or subcutaneous in a double-blind placebo controlled setting. Immune cells will be monitored from the blood over time.

Detailed description: Vitamin D-deficient individuals will receive once

* double-blind, placebo controlled 100.000 I.U.vitamin D3
* intramuscular or subcutaneous

Blood will be taken over time and

* immune cells (T cells, B cells, myeloid antigen presenting cells) are characterized by flow-cytometry
* vitamin D-metabolites will be monitored

Eligibility criteria: Inclusion Criteria:

* informed consent
* 18-60 yrs
* 25-hydroxyvitamin D serum below 50 nmol/L
* women only: effective contraception

Exclusion Criteria:

* 25-hydroxyvitamin D serum above 50 nmol/L
* body-mass index \<18 or \>30 kg per m2
* planned UV-exposure (UV-index \> 5)
* hypersensitivity to vitamin D
* history of hypercalcemia, kidney stones, kidney insufficiency, sarcoidosis, pseudohyperparathyroidism concomitant vitamin A- and/or vitamin D treatment
* treatment with immunosuppressants, immunomodulators, phenytoin, barbiturate, thiazide-diuretics, glycosides
* immobile patients
* out of normal range on screening visit (calcium,phosphate,creatinin,hematology)
* psychiatric hospitalization
* pregnancy / breast-feeding
* dependency / relationship on sponsor
* concomitant participation in other clinical trials (30 days before)
* drug or alcohol abuse
* lack of compliance

Primary outcomes:
measure: Change in the numbers of vitamin D-responsive B cells after vitamin D administration.
timeFrame: up to 3 months
Secondary outcomes:
measure: Characterize vitamin D-responding myeloid immune cells
timeFrame: up to 3 months
measure: Impact of vitamin D on specific humoral memory
timeFrame: up to 3 months
measure: Vitamin D pharmacokinetics
timeFrame: up to 3 months
measure: Characterize vitamin D-responsive T cells
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Dpt of Dermatology and Allergology, Charité University Medicine Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Margitta Worm, Prof
role: PRINCIPAL_INVESTIGATOR
References: