louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03226431: Use of ARINA-1 in an Intermediate Size Patient Population of Bilateral Lung Transplant Patients With CLAD Grade 0
Official title: Use of ARINA-1 in an Intermediate Size Patient Population of Bilateral Lung Transplant Patients With CLAD Grade 0 at Duke University to Improve FEV1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lung Transplant
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 6
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To treat an intermediate size patient population of bilateral lung transplant patients with CLAD-0.

Detailed description: To treat an intermediate size patient population of bilateral lung transplant patients with CLAD-0. Treating physicians will follow standard of care for patients and monitor pulmonary function, fractional exhaled nitric oxide and quality of life of the patients.

Patient safety will be monitored by assessing changes in these parameters, as well as changes in standard of care measurements (e.g., laboratory values and x-ray images).

Eligibility criteria: Inclusion Criteria:

1. \>6 months post-bilateral lung transplant
2. Any patient with a stable FEV1 or a decline that is \< 20% from baseline.
3. No current signs of infection
4. No current signs of rejection
5. \>21 years old
6. Routinely followed at the enrolling site
7. Capable of giving informed consent

Exclusion Criteria:

1. Interstitial or peribronchial/peribronchiolar fibrosis on transbronchial biopsy
2. Evidence of active congestive heart failure or symptomatic coronary artery disease, in the opinion of the site investigator
3. CLAD grade 1 or higher
4. Currently on any ICS therapy
5. Initiation of chronic azithromycin within 1 month of study enrollment (chronic azithromycin use defined as azithromycin 250mg or 500mg daily or every Monday, Wednesday, Friday)
6. Positive pregnancy test at screening, if female and of child bearing potential

Primary outcomes:
measure: Changes in FEV1
timeFrame: Baseline, 1 month, 3 months, 6 months, 12 months
measure: Changes in FENO
timeFrame: Baseline
measure: Changes in Quality of Life
timeFrame: Baseline, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke Health
name: Omar Mohamedaly, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke Health
name: Lorenzo Zaffiri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04071431: A Questionnaire for Endoscopic Prediction Improvement of Gastrointestinal Cancer
Official title: A Self-rating Risk Factor Questionnaire for the Improvement of Endoscopic Prediction of Gastrointestinal Cancer: a Big-data-based Diagnostic Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Early Detection of Cancer
Keywords: Early Detection of cancer
Gastrointestinal Neoplasms
Endoscopy, Gastrointestinal
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 34906
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Despite improvements in a range of chemo, radio and surgical therapies, the overall survival at 5 years from gastrointestinal cancer remains poor. Endoscopic early diagnosis is a key strategy to improve survival but the detection rate of early cancer varies among different countries. Risk factor questionnaire result is easy to be obtained and may be of great help for improving the detection rate. The aim of this research is to validate a risk factor questionnaire to help predict gastrointestinal cancer therefore allowing earlier diagnosis and higher detection rate.


Eligibility criteria: Inclusion Criteria:

* Patients aged more than 18 years with or without GI symptoms attending for endoscopy.

Exclusion Criteria:

* Patients unable to cooperated the endoscopy or unable to complete it. People with endoscopy contraindications are naturally excluded.

Primary outcomes:
measure: Rate change
timeFrame: up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
References:
Clinical trial NCT00922831: Progression of Cognitive and Physical Symptoms in Multiple Sclerosis
Official title: Progression of Cognitive, Affective, and Physical Symptoms in Multiple Sclerosis.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Multiple Sclerosis
Keywords: Cognition, Affective MS symptoms
Lead sponsor: MidAmerica Neuroscience Research Foundation at Rowe Neurology Institute
Sponsor class: OTHER
Collaborators: name: University of Missouri, Kansas City
First posted: 2009-06-17
Enrollment: 0
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: Neurology Care Clinic

Brief summary: The purpose of this study is to look at multiple sclerosis patients process of awareness, learning, and judging status over a 3 year time period.

Detailed description: Patients with multiple sclerosis (MS) frequently experience cognitive and emotional difficulties. Theses neuropsychiatric symptoms are known to be associated with reduced quality of life. However, little is known about the evolution of MS patients' neuropsychiatric difficulties and how these neuropsychiatric changes may be related to other MS symptoms. The purpose of the present study is to examine MS patients' cognitive and emotional status over time as part of standard neuropsychological evaluations in a private practice setting. MS patients presenting for neuropsychological evaluation at the MidAmerica Neuroscience Institute will be provided with the option of participating in thorough evaluation of their cognitive and affective MS symptoms. They will then be followed clinically and receive re-evaluation over a period of 3 years on a yearly basis. It is hoped that this study will help us obtain a better understanding of the factors associated with worsening cognition in MS. A greater understanding of the factors associated with cognitive and affective decline in MS help could lead to the early identification and treatment of at-risk patients.

Eligibility criteria: Inclusion Criteria:

* Male/female subjects at least 18 years of age with a diagnosis of Clinically Definite Multiple Sclerosis (CDMS) or Clinically Isolated Syndrome (CIS)as confirmed by a neurologist.
* Subjects must be able to give written informed consent and comply with the study protocol. Subjects must also be able to read, write and understand English.
* Are capable of performing the requirements of the neuropsychological test battery.

Exclusion Criteria:

* As judged by the investigator, any clinically significant, unstable or major concomitant disorder or medications.
* In the opinion of the Investigator should not participate in the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: MidAmerica Neuroscience Research Foundation at Rowe Neurology Institute
name: Hunter T Feaster, PsyD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Missouri, Kansas City
name: Jared Bruce, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03791931: Cleavage Pattern of Embryos and Oxidative Parameters
Official title: Is Abnormal Cleavage Pattern of Embryos Associated With Different Oxidative Parameters Compared With That of Normally Cleaving Embryos? A Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2019-01-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To investigate prospectively whether embryos with abnormal cleaving pattern have different oxidative parameters from normally cleaving embryos, and to analyze whether these parameters have an association with demographic, laboratory and clinical parameters including treatment outcome.

Detailed description: To investigate prospectively whether embryos with abnormal cleaving pattern have different oxidative parameters from normally cleaving embryos, and to analyze whether these parameters have an association with demographic, laboratory and clinical parameters including treatment outcome.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing IVF for the treatment of infertility

Exclusion Criteria:

* Age \<18 or \>45 years old
* Patients with no embryos with direct cleavage

Primary outcomes:
measure: implantation rate
timeFrame: 1 year
measure: clinical pregnancy rate
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel Medical Center
Study officials:
affiliation: Carmel Medical Center
name: Zofnat Wiener, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03655431: Home Exercise Telerehabiliation for MS
Official title: Telerehabilitation Using Kinect-based VR to Improve Mobility and Fatigue in Veterans With MS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
rehabilitation
telerehabilitation
telehealth
veteran health
physical therapy
Lead sponsor: Washington D.C. Veterans Affairs Medical Center
Sponsor class: FED
First posted: 2018-08-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: An experimental and control group will be utilized. The experimental group will perform the telerehabilitation intervention.
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to evaluate the effects of an individualized telerehabilitation program on mobility, fatigue, and quality of life for Veterans with MS. The secondary purpose was to assess adherence to exercise recommendations and overall satisfaction with the intervention.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of MS based on the McDonald criteria
* Expanded Disability Status Scale (EDSS) of 3.0 - 6.5
* Cognitive ability (Montreal Cognitive Assessment score \>23/30)
* Physician clearance for exercise participation
* Physical therapy referral

Exclusion Criteria:

* MS-related exacerbation within last 3 months
* Unstable cardiac or pulmonary disease
* Active substance abuse
* Uncontrolled seizures

Primary outcomes:
measure: Multiple Sclerosis Walking Scale-12 (MSWS-12)
timeFrame: Change after 12-week intervention
Secondary outcomes:
measure: Short Physical Performance Battery (SPPB)
timeFrame: Change after 12-week intervention
measure: 25-Foot Walk Test (25FWT)
timeFrame: Change after 12-week intervention
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: Change after 12-week intervention
measure: Veteran Rand 12 Quality of Life Measure (VR-12)
timeFrame: Change after 12-week intervention
Other outcomes:
measure: Patient Travel
timeFrame: Start of participation
Locations:
city: Washington
country: United States
facility: Washington DC VAMC
state: District of Columbia
Study officials:
affiliation: Washington DC VAMC
name: Mitchell Wallin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chanpimol S, Benson K, Maloni H, Conroy S, Wallin M. Acceptability and outcomes of an individualized exergaming telePT program for veterans with multiple sclerosis: a pilot study. Arch Physiother. 2020 Oct 1;10:18. doi: 10.1186/s40945-020-00089-5. eCollection 2020.
Clinical trial NCT00197431: Pharmacokinetic and Pharmacodynamic Study of S-1 in Patients With Digestive Organ Cancer
Official title: Pharmacokinetic and Pharmacodynamic Study of S-1 and Its Effects in Patients With the Digestive Organ Cancer With Reference to Genetic Polymorphism and Activity of CYP2A6 and DPD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Esophageal Cancer
Pancreatic Cancer
Colon Cancer
Lead sponsor: Hamamatsu University
Sponsor class: OTHER
First posted: 2005-09-20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: S-1 is a novel oral fluorouracil antitumor drug that consists of tegafur which is a prodrug of 5-fluorouracil (5-FU); 5-chloro-2,4-dihydropyridine (CDHP), which inhibits dihydropyrimidine dehydrogenase (DPD) activity; and potassium oxonate (Oxo), which reduces gastrointestinal toxicity. 5-FU is metabolized by CYP2A6 and DPD. In this study, the researchers investigate the influences of differences in activities of CYP2A6 and DPD on pharmacokinetics and pharmacodynamics of S-1 and clinical outcomes in digestive organ cancer patients treated with S-1.


Eligibility criteria: Inclusion Criteria:

* Patients with digestive organ cancer

Exclusion Criteria:

* Patients without digestive organ cancer

Primary outcomes:
measure: Whether the differences in activities of CYP2A6 and DPD affect pharmacokinetics and pharmacodynamics of S-1 and clinical outcomes
Secondary outcomes:
measure: Side effect and motility of patients treated with S-1
Other outcomes:
Locations:
city: Hamamatsu
country: Japan
facility: Hamamatsu University School of Medicine
state: Shizuoka
Study officials:
affiliation: Department Laboratory Medicine, Hamamatsu University School of Medicine
name: Naohito Shirai, MD., PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05186831: Patient-Portal vs Text-based Hypertension Monitoring Among Black Medicaid/Medicare Patients
Official title: Patient-Portal vs Text-based Hypertension Monitoring Among Black Medicaid/Medicare Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Cardiovascular Diseases
Keywords: Racial disparities
Digital technology
Hypertension
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The coronavirus disease 2019 (COVID-19) pandemic has uprooted conventional health care delivery for routine ambulatory care, requiring health systems to rapidly adopt telemedicine capabilities. The digital divide, has been well documented with lower rates of technology and broadband adoption among racial/ethnic minorities. Additionally, Black patients suffer a disproportionate burden of hypertension and cardiovascular disease. This study will implement a text-based home hypertension monitoring program among Black Medicaid patients with hypertension and cardiovascular disease (CVD) and compare its uptake to the currently available blood pressure monitoring program using the patient portal that is integrated into the electronic health record (EHR).


Eligibility criteria: Inclusion Criteria:

* Self-identified Black race
* Medicaid or Medicare insurance
* Hypertension
* Cardiovascular disease or presence of at least 1 cardiovascular risk factor
* Seen for in-person consultation at the Heart and Vascular clinic at the Hospital of the University of Pennsylvania

Exclusion Criteria:

* Does not speak English
* Already owns a BP cuff
* Does not have internet access or a phone 15 with texting capabilities

Primary outcomes:
measure: Number of BP measurements reported
timeFrame: 14 days
measure: Proportion of patients submitting 1 or more BP measurement
timeFrame: 14 days
Secondary outcomes:
measure: Patient satisfaction
timeFrame: Within 2 weeks of end of study period
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01084031: Dose Titration of Propofol for Tracheal Intubation in Children With Sevoflurane Inhalation Induction
Official title: Dose Titration of Propofol for Tracheal Intubation in Children With Sevoflurane Inhalation Induction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Urinary Disorders
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2010-03-10
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Dose titration of propofol for tracheal intubation in children with sevoflurane inhalation induction.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients scheduled for elective day case surgery were enrolled.

Exclusion Criteria:

* History of obstructive sleep apnea
* Evidence of cardiorespiratory disease
* Those who were obese or allergic to any of the anesthetic agents in this study
* Those with an anticipated difficult airway, full stomach
* History of malignant hyperthermia or other myopathy were excluded.

Primary outcomes:
measure: Assessment of intubation conditions
timeFrame: 30 minutes after the surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Korea
name: Hae Keum Kil
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00985231: Performance Evaluation of Contact Lenses Among a Population of Adapted Contact Lens Wearers
Official title: Performance Evaluation of Contact Lenses Among a Population of Adapted Contact Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vision Disorders
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2009-09-28
Enrollment: 272
Sex: ALL
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being conducted to evaluate Bausch \& Lomb PureVision Multi-Focal contact lenses compared to the Bausch \& Lomb SofLens59 contact lens when worn by adapted soft contact lens wearers on a daily wear basis.


Eligibility criteria: Inclusion Criteria:

* Subjects must have clear central corneas and be free of any anterior segment disorders.
* Subjects must be adapted soft contact lens wearers and agree to wear the study lenses on a daily wear basis for at least eight hours a day for approximately two weeks.
* Subjects must wear a lens in each eye and each lens must be of the same manufacture and brand.

Exclusion Criteria:

* Subjects participating in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation.
* Subjects with any systemic disease affecting ocular health
* Subjects with an active ocular disease or using any ocular medication.
* Subjects who have had any corneal surgery (eg, refractive surgery).

Primary outcomes:
measure: Distance Visual Acuity (VA) Between Test and Control Lenses Worse Than 20/40.
timeFrame: 2 weeks
Secondary outcomes:
measure: Subjective Ratings of Eye Strain
timeFrame: 2 week visit
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Beverly J Barna
role: STUDY_DIRECTOR
References:
Clinical trial NCT06082531: Effect of Platelet-rich Plasma (PRP) Injection on Knee Osteoarthritis
Official title: Therapeutic Effect of Platelet-rich Plasma (PRP) Injection on Knee Osteoarthritis and Periarticular Tissue Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Platelets-rich Plasma
Osteoarthritis Knees Both
Meniscus Disorder
Cartilage Injury
Keywords: platelets-rich plasma
Osteoarthritis
Cartilage Injury
Meniscus Injury
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and effectiveness of PRP injection therapy in the repair of osteoarthritis and periarticular soft tissue injury through a single-center, exploratory clinical study, and to provide a more reliable basis for the treatment of joint injury.


Eligibility criteria: Inclusion Criteria:

* The age range of the participants was 20 to 60 years old. Through a comprehensive clinical and imaging examination, it was conclusively determined that the individuals had knee osteoarthritis or experienced injuries to the cart, and meniscus surrounding the knee joint.
* The preoperative routine tests and examinations revealed no contraindications.
* Revised sentence: "Informed consent of the patient

Exclusion Criteria:

* The platelet count or function exhibits significant abnormalities、Systemic infection transmitted through the bloodstream.
* Prolonged usage of anti-inflammatory drugs and systemic corticoid administration.
* In injection site or damage to the skin.
* Patients with tumors or undergoing radiotherapy and chemotherapy.
* Pregnant or breastfeeding women.
* Individuals with mental illnesses who are unable to cooperate with follow-up procedures.
* Contraindications for MRI、Patients or their families do consent to participate in the study.
* Other circumstances that render participation in the study unsuitable.

Primary outcomes:
measure: X-ray
timeFrame: pre-operation,3 weeks after treatment, 6 months after treatment
measure: CT
timeFrame: pre-operation,3 weeks after treatment, 6 months after treatment
measure: MRI
timeFrame: pre-operation,3 weeks after treatment, 6 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shannxi
Study officials:
References:
citation: Ramos-Gonzalez G, Salazar L, Wittig O, Diaz-Solano D, Cardier JE. The effects of mesenchymal stromal cells and platelet-rich plasma treatments on cutaneous wound healing. Arch Dermatol Res. 2023 May;315(4):815-823. doi: 10.1007/s00403-022-02451-y. Epub 2022 Nov 3.
citation: Zhang Y, Xing F, Luo R, Duan X. Platelet-Rich Plasma for Bone Fracture Treatment: A Systematic Review of Current Evidence in Preclinical and Clinical Studies. Front Med (Lausanne). 2021 Aug 3;8:676033. doi: 10.3389/fmed.2021.676033. eCollection 2021.