louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04040283: Platelet-rich Plasma for Menical Tear
Official title: Platelet-rich Plasma for Menical Tear
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Platelet-Rich Plasma
Meniscus Lesion
Keywords: Growth factors
Meniscal injury
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Skeletally mature patients aged between 18 and 70 years with imaging and clinical diagnosis of meniscus injury and no indication of meniscus repair surgery

Brief summary: Meniscal injuries are a common pathology among athletes, and have an impact on the daily or sporting practice of patients. Surgical approach implies sometimes heavy consequences. Platelet-rich-plasma (PRP) has been shown to be effective in accelerating wound healing and tissue regeneration in orthopedic and oral surgery. This clinical trial aims to investigate the safety and efficacy of intraarticular and periferal PRP injection in patients with stable meniscal injury. The pre- and post-interventional clinical outcomes will be compared.


Eligibility criteria: Inclusion Criteria:

* Skeletally mature patients 18-70 years of age
* With diagnosis of meniscus injury
* Single tear of the medial and/or lateral meniscus
* With no indication of meniscus repair surgery

Exclusion Criteria:

* Prior history of multiple ligaments injury, associated significant ligament instability: Grade III MCL, Grade III PCL, or ACL deficient knee
* Prior history of knee surgery
* Discoid meniscus
* Osteoarthritic changes (Kellgren Lawrence scale \>2)
* Inflammatory diseases (i.e. rheumatoid arthritis)
* Underlying bleeding disorder or coagulopathy
* Concominant chondral defects (\> 2 ICRS)
* Cancer patients
* Pregnancy
* Patients who will not cooperate with six-month followup

Primary outcomes:
measure: Knee injury and Osteoarthritis Outcome Score scale
timeFrame: 6months post procedure
measure: Visual Analog Scale
timeFrame: 6months post procedure
Secondary outcomes:
measure: International Knee Documentation Committee - Subjective Knee Evaluation Form
timeFrame: 6months post procedure
measure: Satisfaction Level
timeFrame: 6months post procedure
Other outcomes:
Locations:
city: Malaga
country: Spain
facility: Ivan Medina-Porqueres
Study officials:
References:
Clinical trial NCT02117583: Effects of Food on Oxycodone Pharmacokinetics in Healthy Volunteers
Official title: An Open-Label, Randomized, 2-Cohort, Single-Dose, Crossover Study To Estimate The Effects Of Food On Oxycodone Pharmacokinetics Following Oral Administration Of 40 Mg Doses Of Pf 00345439 Formulation K Taken Whole Or After Chewing In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: pharmacokinetics
relative bioavailability
food effects
oxycodone
Lead sponsor: PainT
Sponsor class: UNKNOWN
First posted: 2014-04-21
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: To estimate the effect of food on the pharmacokinetics and relative bioavailability of oxycodone following oral administration of single 40 mg doses of PF 00345439 Formulation K taken whole or after chewing in healthy volunteers. We have described below the two cohorts each with two arms in this crossover study by listing them as four Arms/Groups in order to capture the differences between the cohorts prior to the crossover and after the crossover. 14 participants are planned for the first cohort and 18 participants are planned for the second cohort.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between 18 and 55 years of age

Exclusion Criteria:

* Evidence or history of clinically significant disease.
* Positive urine drug test

Primary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
timeFrame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48
measure: Concentration at time 24 hours (C24)
timeFrame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01211561: Colon Cancer Prevention Using Selenium
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Prevention of Colorectal Cancer
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2010-09-29
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Selenium's ability to prevent colorectal cancer (CRC) has been suspected for nearly 30 years, but has never been directly studied in humans. The investigators will directly assess selenium's ability to prevent CRC by measuring alterations in aberrant crypt foci (ACF), an accepted surrogate marker for CRC.

ACF's are very small (i.e., microscopic) collections of abnormally shaped cells that are a commonly used marker of CRC risk. Screening colonoscopy at UIC routinely uses methods that allow ACF counting to be done as a part of standard practice. ACF's are not fixed, like polyps or cancers, but can disappear as a person's risk for developing CRC decreases.

The investigators propose giving patient's with 6 or more ACF's 200 mcg selenized yeast or placebo, and determining if there is a drug-dependant decrease in ACF number. The primary objective is to determine whether selenized yeast supplementation, compared to placebo, causes significant reduction of ACF number from baseline levels. The primary endpoint will be change in ACF number


Eligibility criteria: Inclusion Criteria:

- All non-pregnant patients \>50 years of age

Exclusion Criteria:

* The following will be specifically looked for, and result in patients not being eligible for study enrollment:

  * Use of non-steroidal anti-inflammatory drugs or glucocorticosteroids within 60 days of study entry.
  * History of chronic IBD or prior pelvic radiation (inflammation distorts crypt pattern).
  * Intake of any selenium supplements within 60 days of study entry, including vitamins.
  * Patients with increased bleeding risk from biopsy protocol (i.e. renal failure, decompensated cirrhosis, blood dyscrasia).

Primary outcomes:
measure: Reduction in ACF biomarkers
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Richard V Benya, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01572961: Microvascular Function Assessment in Healthy Subjects
Official title: Amélioration Des Techniques d'étude de la Micro-cirulation cutanée Chez Des Sujets Sains
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physiology of Microvascular Skin
Keywords: Laser Doppler flowmetry, skin, microcirculation
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2012-04-06
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Current stimulation induces microvascular dilation in human skin. The investigators aimed to study (1) whether the current vasodilation is amplified after two segmental current stimulation as compared to one stimulation; (2) whether this amplification relies on prostaglandin-sensitive mechanisms. A double-blind randomized placebo-controlled crossover trial is conducted in Angers, France.


Eligibility criteria: Inclusion Criteria:

* Age \> or equal to 18 years old
* Healthy subjects

Exclusion Criteria:

* Aspirin allergy

Primary outcomes:
measure: The increase of Laser Doppler Blood Flow after the second current stimulation
timeFrame: 1 hour
Secondary outcomes:
measure: The increase of Laser Doppler Blood Flow after the second current stimulation after aspirin administration
timeFrame: 1 hour
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital
state: Maine et Loire
Study officials:
affiliation: University hospital of Angers
name: Guillaume Mahe, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mahe G, Abraham P, Humeau-Heurtier A, Gascoin L, Leftheriotis G, Durand S. Evidence for a vasomotor cyclo-oxygenase dependent mechanism of sensitization at the cutaneous level. Br J Clin Pharmacol. 2015 Aug;80(2):185-92. doi: 10.1111/bcp.12623. Epub 2015 May 26.
Clinical trial NCT03883061: Mathematical Modeling and Risk Factor Analysis for Mortality of Sepsis
Official title: Mathematical Modeling and Risk Factor Analysis for Mortality of Sepsis Based on Real World Data in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Morality
Risk Factor, Sepsis
Predictive Model
Lead sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine
Sponsor class: OTHER
Collaborators: name: Department of Emergence, The First Hospital Affiliated to South China University, Hengyang, Hunan, China.
name: Department of Integrative Medicine, Huashan Hospital of Fudan University, Shanghai, China
name: Department of Biomedical Informatics and Statistics, Insitute of Integrative Medicine, Fudan University, Shanghai, China
name: Department of emergence, Hunan people's hospital, Changhai, Hunan, China
name: Department of emergence, The hospital affiliated to Jining medical college, Jining, Shandong, China
name: Department of emergence, Huaihua people's hospital, Huaihua, Hunan, China
First posted: 2019-03-20
Enrollment: 2000
Sex: ALL
Minimum age (years): 14
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: all patients with sepsis in emergence department of hospitals

Brief summary: The purpose of this study was to investigate the risk factors for mortality of sepsis and to create mathematical models to predict the survival rate based on electronic health records that extracted from hospital information system. More than 1000 records should be collected and used to data analysis. Univariate and multivariable logistic regression model were applied to risk factors analysis for the outcome, and machine learn algorithms were employed to generate predictive models for the outcome.


Eligibility criteria: Inclusion Criteria:

* all records with sepsis in emergence department of hospitals

Exclusion Criteria:

* subjects with major missing data

Primary outcomes:
measure: mortality of sepsis
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zihui Tang
Study officials:
References:
citation: Lu Y, Tang ZH, Zeng F, Li Y, Zhou L. The association and predictive value analysis of metabolic syndrome combined with resting heart rate on cardiovascular autonomic neuropathy in the general Chinese population. Diabetol Metab Syndr. 2013 Nov 17;5(1):73. doi: 10.1186/1758-5996-5-73.
Clinical trial NCT01172561: Community Awareness Resources and Education - Project 1
Official title: Reducing Cervical Cancer in Appalachia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-07-29
Enrollment: 280
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: To increase early detection of cervical cancer by increasing the proportion of Appalachian women, age 18 and older, who receive Pap smears at appropriate intervals and return for follow-up care when necessary.

Detailed description: The overall goal of Project 1 is to increase early detection of cervical cancer by increasing the proportion of Appalachian women, age 18 and older, who receive Pap smears at appropriate intervals and return for follow-up care when necessary. The project was implemented in Appalachian Ohio, a mainly rural and underserved area with a population comprised of 1.5 million adults, aged 18 and older, and used community-based participatory research (CBPR) and community relationships already established in the area by Center investigators.

Eligibility criteria: Inclusion Criteria:

* women age 18 and older

  * who have visited participating clinics during the last two years and
  * who consider themselves to be a current patient of that clinic

Exclusion Criteria:

* Not a resident of the selected Ohio Appalachia county
* Under the age of 18

Primary outcomes:
measure: Receipt of Cervical Cancer screening via Pap Test
timeFrame: past 12-14 months (yes/no).
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: The Ohio State University Comprehensive Cancer Center
name: Electra D Paskett, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paskett ED, McLaughlin JM, Lehman AM, Katz ML, Tatum CM, Oliveri JM. Evaluating the efficacy of lay health advisors for increasing risk-appropriate Pap test screening: a randomized controlled trial among Ohio Appalachian women. Cancer Epidemiol Biomarkers Prev. 2011 May;20(5):835-43. doi: 10.1158/1055-9965.EPI-10-0880. Epub 2011 Mar 23.
Clinical trial NCT00004361: Study of the Relationship Between Calcium Levels and Intact Parathyroid Hormone (iPTH) in Adults With Repaired or Palliated Conotruncal Cardiac Defects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoparathyroidism
Tetralogy of Fallot
Pulmonary Valve Stenosis
Conotruncal Cardiac Defects
Heart Defects, Congenital
Pulmonary Atresia
Keywords: DiGeorge syndrome
cardiovascular and respiratory diseases
conotruncal cardiac defects
endocrine disorders
genetic diseases and dysmorphic syndromes
hypoparathyroidism
pulmonary valve stenosis
rare disease
tetralogy of Fallot
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Ann & Robert H Lurie Children's Hospital of Chicago
First posted: 1999-10-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: OBJECTIVES: I. Identify latent hypoparathyroidism in normocalcemic adult survivors with repaired conotruncal cardiac defects, by evaluating parathyroid gland secretory function after induced hypocalcemia.

II. Determine the relationship of parathyroid hormone secretion to microdeletions in the same region of chromosome 22q11 as found in patients with DiGeorge anomaly.

Detailed description: PROTOCOL OUTLINE:

Patients are given sodium citrate over a 2 hour infusion on day 1. Blood is drawn at times -30, -15, 0, and every 10 minutes thereafter during the infusion. On day 2, patients are given calcium gluconate over a 2 hour infusion. Blood is drawn at times -30, -15, 0, and every 10 minutes thereafter during the infusion.

Eligibility criteria: * Diagnostically shown repaired or palliated conotruncal cardiac defects, including tetralogy of Fallot with pulmonary stenosis or pulmonary atresia, truncus arteriosus, or interrupted aortic arch type B

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Craig B. Langman
role: STUDY_CHAIR
References:
Clinical trial NCT00189761: A Study to Assess Efficacy, Safety and Pharmacokinetics of a Tacrolimus New Oral Formulation (MR4) in BMT Recipients
Official title: A Phase 2, Open-Label, Multi-Center Study to Assess Efficacy, Safety and Pharmacokinetics of a Tacrolimus New Oral Formulation (MR4) in De Novo Bone Marrow Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bone Marrow Transplantation
Graft Versus Host Disease
Graft-Vs-Host Disease
Graft-Versus-Host Disease
Keywords: Tacrolimus
Immunosuppression
Bone Marrow Transplantation
Graft versus Host Disease
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2005-09-19
Sex: ALL
Minimum age (years): 20
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A study to assess efficacy, safety and pharmacokinetics of a tacrolimus new oral formulation (MR4) in de novo bone marrow transplant recipients


Eligibility criteria: Inclusion Criteria:

* Bone marrow transplantation patients aged 20-54 except for transplanted from genetically HLA matched sibling donor.
* The patient had been fully informed.

Exclusion Criteria:

* The patient had severe impaired hepatic function.
* The patient had impaired renal function.
* The patient had existing complication of severe cardiac dysfunction.
* The patient had severe impaired pulmonary function.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chubu region
country: Japan
city: Hokkaido region
country: Japan
city: Kanto region
country: Japan
city: Kyusyu region
country: Japan
Study officials:
affiliation: Astellas Pharma Inc., Japan
name: Clinical development
role: STUDY_CHAIR
References:
Clinical trial NCT06490861: Performance of the Paragit Sleeve to Measure and Monitor Motor Symptoms in Patients With Parkinson's Disease
Official title: An Open Multi-centre Investigation to Evaluate the Performance of the Paragit Sleeve With build-in sEMG Sensors, Kinetic Sensors, and Smart-textile to Measure and Monitor Motor Symptoms and Treatment-induced Dyskinesia in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Paragit ApS
Sponsor class: INDUSTRY
First posted: 2024-07-08
Enrollment: 25
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This investigation is undertaken to:

* Evaluate the accuracy and reliability of the device in measuring and recording motor symptoms associated with Parkinson's Disease (PD), and
* To assess the safety and tolerability of the device in patients with PD.


Eligibility criteria: Inclusion Criteria:

1. Parkinson disease: Clinically diagnosed
2. Age ≥ 50 (not in the childbearing aged as defined by Statistics Denmark, 15-49)
3. Experiencing at least two of following symptoms and/or side effect on a daily basis:

   * Rigidity
   * Tremor
   * Bradykinesia
   * Dyskinesia (treatment side effect)
4. Provision of informed consent, i.e., the subject must be able to:

   * Read and understand the Patient Information and Consent Form
   * Sign the Patient Information and Consent Form.

Exclusion Criteria:

1. Known allergy/hypersensitivity to any material in direct contact with the skin (stainless steel, silicone and polyester)
2. MMSE \<24
3. Other neurological diseases

Primary outcomes:
measure: Tremor
timeFrame: During the clinical assessment, and for the following 24h.
measure: Bradykinesia
timeFrame: During the clinical assessment, and for the following 24h.
measure: Rigidity
timeFrame: During the clinical assessment, and for the following 24h.
measure: Dyskinesia
timeFrame: During the clinical assessment, and for the following 24h.
Secondary outcomes:
measure: Safety
timeFrame: During the clinical assessment , and for the following 24h.
measure: Usability
timeFrame: During the clinical assessment , and for the following 24h.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Beata María Ana
Study officials:
References:
Clinical trial NCT01548261: Donating Oral Mucosal Cells for the Study of ex Vivo Culture of Cells Sheets
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Keywords: obtain the oral mucosal tissue from healthy donors
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2012-03-08
Enrollment: 1
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health people.

Brief summary: Cultivated oral mucosal epithelial sheets on amniotic membrane have been reported to have good clinical results in treating patients with ocular surface disorders in both human and animal studies. However, such technique has not been well established in this hospital. The main purpose of this study is to obtain the discarded oral mucosal tissue from healthy donors who volunteer to donate their oral mucosa from buccal area. The obtained oral mucosal tissue will be cultured under different types (co-culture with or without 3T3 cells)。Inverted light microscopy, electron microscopy and immunostaining with K3/K12, K14, Ki67, P63, connexin 43, and involucrin will be preformed to test the effects of foreskin cell line co-culture system on cell condition. The investigators plan to start the study from Jan. 1st, 2011 to Dec. 31th, 2015. Thirty patients will be enrolled.


Eligibility criteria: Inclusion Criteria:

* The age 20 to 55 year-old healthy contributor.
* does not have disease of the oral cavity.

Exclusion Criteria:

* In the past had the oral mucosa disease, wound cicatrization bad, or hemoglutination condition not good medical history. Sickness must stop using above any anti-hemoglutination medicine one week.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital, department of Ophthalmology
Study officials:
References: