louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02465671: Prognostic Value of Plasma Thrombospondin-1 Levels After Acute Intracerebral Hemorrhage
Official title: Prognostic Value of Plasma Thrombospondin-1 Levels After Acute Intracerebral Hemorrhage：A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Hemorrhage
Lead sponsor: Jinhua People's Hospital
Sponsor class: OTHER
First posted: 2015-06-08
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with acute spontaneous basal ganglia hemorrhage admitted to the Jinhua People's Hospital within the first 24 h from stroke were enrolled.

Brief summary: The current study was designed to investigate the change of plasma thrombospondin-1 levels and assess the prognostic predictive effect of plasma thrombospondin-1 levels in the patients with acute intracerebral hemorrhage.

Detailed description: Thrombospondin-1 acts as an anti-angiogenic factor and its expression in rat brain is upregulated after intracerebral hemorrhage. The current study was designed to investigate the change of plasma thrombospondin-1 levels and assess the prognostic predictive effect of plasma thrombospondin-1 levels in the patients with acute intracerebral hemorrhage. About 110 patients will be recruited. All blood samples from the patients at admission were collected. Thrombospondin-1 levels in plasma were measured using sandwich immunoassays. The patients will be followed up till 6 months after intracerebral hemorrhage. The relationships between plasma thrombospondin-1 levels and 1-week mortality, 6-month mortality, 6-month overall survival, 6-month unfavorable outcome (modified Rankin Scale score \>2) and disease severity reflected by hematoma volume and National Institutes of Health Stroke Scale score were assessed using multivariate analysis. It is proposed that elevated plasma thrombospondin-1 levels are independently associated with disease severity and clinical outcomes. It will be suggested thrombospondin has potential to be a good prognostic biomarker of intracerebral hemorrhage.

Eligibility criteria: Inclusion Criteria:

* acute spontaneous basal ganglia hemorrhage admitted to the Jinhua People's Hospital within the first 24 h from stroke.

Exclusion Criteria:

* previous ischemic or hemorrhagic stroke, severe head trauma, use of antiplatelet or anticoagulant medication, presence of other prior systemic diseases including autoimmune diseases, uremia, liver cirrhosis, malignancy, and chronic heart or lung disease, recent infection (within a month), a surgical procedure and missing of follow-up.

Primary outcomes:
measure: mortality after intracerebral hemorrhage
timeFrame: Follow-up of 6 months
Secondary outcomes:
measure: Unfavorable outcome (modified Rankin Scale score >2 )
timeFrame: Follow-up of 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Jinhua People's Hospital
name: Zhen-Yu CHENG
role: STUDY_CHAIR
References:
Clinical trial NCT05398471: Medical Trial: Appraising Medical Trial Experiences of Rheumatoid Arthritis Patients
Official title: Observational Clinical Trial Appraising Medical Trial Experiences of Rheumatoid Arthritis Patients Participating In Clinical Research
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Rheumatoid Arthritis
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-01
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Rheumatoid arthritis patients who are actively considering enrolling in an interventional clinical trial, but have not yet completed enrollment and randomization.

Brief summary: Historically, participation in clinical trials has been highly skewed towards specific demographic groups. However, research identifying which trial attributes impact participation, in either positive or negative ways, is limited. This study invites participants to record a wide range of data on their clinical trial experience, with the goal being to identify factors which persistently limit patients' ability to participate in, or complete, a trial in which they were initially interested. This data will be analyzed through a range of demographic lenses, in hopes of discovering patterns which might improve the experience of future rheumatoid arthritis patients.


Eligibility criteria: Inclusion Criteria:

* Patient has been diagnosed with rheumatoid arthritis
* Patient has self-identified as planning to enroll in an interventional clinical trial
* Patient is 18 years old

Exclusion Criteria:

* ECOG score of 4
* Patient is pregnant
* Inability to perform regular electronic reporting
* Patient does not understand, sign, and return consent form

Primary outcomes:
measure: Patient decides to enroll in clinical trial
timeFrame: 3 Months
measure: Patient remains in clinical trial to completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: McKinney M, Bell R, Samborski C, Attwood K, Dean G, Eakle K, Yu W, Edge S. Clinical Trial Participation: A Pilot Study of Patient-Identified Barriers. Clin J Oncol Nurs. 2021 Dec 1;25(6):647-654. doi: 10.1188/21.CJON.647-654.
citation: Lansey DG, Hefka TA, Carducci MA, Kanarek NF. Problem Solving to Enhance Clinical Trial Participation Utilizing a Framework-Driven Approach. Clin Adv Hematol Oncol. 2020 Aug;18(8):468-476.
citation: Michos ED, Van Spall HGC. Increasing representation and diversity in cardiovascular clinical trial populations. Nat Rev Cardiol. 2021 Aug;18(8):537-538. doi: 10.1038/s41569-021-00583-8. No abstract available.
Clinical trial NCT00310271: A Safety Study to Assess a DNA Vaccine Administered by Particle Mediated Delivery to the Skin in Healthy Subjects
Official title: A Phase I Study Assessing Safety and Tolerability of a DNA Vaccine With a DNA Encoded Immunostimulator , Administered by Particle Mediated Epidermal Delivery Using the PowderMed ND10 Delivery System in HSV-2 Seronegative Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HSV-2
Keywords: DNA vaccine, immunotherapy, HSV-2, PMED
Lead sponsor: PowderMed
Sponsor class: INDUSTRY
First posted: 2006-04-03
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given and any effects it may have on subjects' wellbeing. The study will also test the ability of vaccine to cause particular immune responses in the body.

Detailed description: Herpes simplex virus type 2 (HSV-2) infection is a serious public health problem, with up to 20% of the US population infected. Following primary infection, HSV-2 establishes a latent infection that can lead to recurrent disease when the virus reactivates. Genital lesions are often experienced with viral recurrence and these can be uncomfortable and painful, resulting in significant anxiety and social distress. There are no commercial vaccines available for therapy of HSV-2 infection.The aim of a therapeutic vaccine would be to enhance such natural responses by boosting the appropriate cellular immune response to HSV-2 in those latently infected individuals who experience frequent and unwanted reactivations. The purpose of this study is to evaluate the safety and tolerability profile of a therapeutic DNA vaccine (pPJV7630) in combination with a DNA encoded immunostimulator (pPJV2012) when administered by Particle Mediated Epidermal Delivery (PMED)

Eligibility criteria: Otherwise healthy subjects with seronegative HSV-2

Primary outcomes:
measure: Safety, tolerability and reactogenicity of the investigational product as determined by AEs and evaluation of the site of vaccination at each visit.
Secondary outcomes:
measure: immunogenicity of vaccine post vaccination
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: CPC Phase I Unit
state: Kansas
Study officials:
affiliation: PRA
name: Steven Komjathy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03815071: A Study on the Treatment of Parkinson's Disease With Autologous Neural Stem Cells
Official title: Clinical Study of the Safety and Efficacy of Autologous Neural Stem Cells in the Treatment of Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Parkinson Disease
Lead sponsor: Allife Medical Science and Technology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: The First People's Hospital of Yunnan Province/First People's Hospital of Yunan Provinve New Kunhua Hospital
name: Henan Provincial People's Hospital
name: Beijing Hospital
First posted: 2019-01-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a single center, single arm and open-label study to investigate the safety and efficacy of iPS-NCS with Parkinson's Disease


Eligibility criteria: Inclusion Criteria:

1. The subject is able to understand the research requirements, provide written informed consent, and complete the study in accordance with the procedures;
2. The subject is clearly diagnosed with Parkinson's;
3. Recorded disease progression over the past 6 months;
4. Vital organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥ 50%, no obvious abnormality in ECG; blood oxygen saturation ≥ 90%; creatinine clearance calculated by Cockcroft-Gault formula ≥ 40ml/min; ALT and AST ≤ 3 times the normal range, total bilirubin ≤ 2.0 mg/dl;
5. Blood routine: Hgb≥80g/L, ANC≥1×109/L, PLT≥50×10/L;

Exclusion Criteria:

1. Mental illness or a neurological disease not associated with Parkinson's disease;
2. Serious other concomitant diseases (tumor, organ failure, etc.);
3. Subjects used a large amount of corticosteroids, immunoglobulins, immunosuppressants before entering the study;
4. Participated in other clinical trials of cell preparations and participated in other clinical trials within 3 months;
5. There are already cognitive impairments or depressions, etc., and the research cannot be completed well;
6. Female subjects who are breast-feeding or have a pregnancy plan recently.

Primary outcomes:
measure: occurrence of treatment related adverse events
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01645371: Assessing a Stool Symptom Screener in Patients With Chronic Opioid-Induced Constipation
Official title: Assessing the Content Validity of a Stool Symptom Screener in Patients With Chronic Opioid-Induced Constipation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid-induced Constipation
Keywords: opioid-induced constipation
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-07-20
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: multi-speciality medical clinics ( family practice, neurology, internal medicine, pain management)

Brief summary: This qualitative research is to assess the validity of the stool symptom screener that will be used in patients with chronic opioid-induced constipation to determine the adequacy of their response to laxatives.

Detailed description: Assessing the Content Validity of a Stool Symptom Screener in Patients with Chronic Opioid-Induced Constipation

Eligibility criteria: Inclusion Criteria:

* Receiving a stable maintenance opioid regimen (total daily dose of 30-1000mg of oral morphine, or equianalgesic amounts of 1 or more other opioid therapies) for a minimum of 4 weeks for non-cancer related pain.
* Development of constipation symptoms since starting opioids.
* Taken laxatives to help with bowel movements for at least four days over the past 2 weeks.

Exclusion Criteria:

* Receiving opioid regimen for treatment of pain related to cancer.
* Participated in any clinical trial or research study relating to opioid use and/or constipation within the past year.
* History of cancer within 5 years from the time of screening.
* Has medical condition(s) and/or treatment(s) associated with diarrhea, intermittent loose stools, or constipation (e.g., fecal incontinence or chronic idiopathic constipation).
* Has irritable bowel syndrome (IBS) or chronic functional constipation.

Primary outcomes:
measure: Semi-structured discussion guide
timeFrame: Data will be collected at ONE time point from each patient using a semi-structured interview guide (up to 5 months)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: Mark Sostek, MD
role: STUDY_DIRECTOR
affiliation: United BioSource
name: Karin S Coyne, PHD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frank L, Kleinman L, Farup C, Taylor L, Miner P Jr. Psychometric validation of a constipation symptom assessment questionnaire. Scand J Gastroenterol. 1999 Sep;34(9):870-7. doi: 10.1080/003655299750025327.
citation: Slappendel R, Simpson K, Dubois D, Keininger DL. Validation of the PAC-SYM questionnaire for opioid-induced constipation in patients with chronic low back pain. Eur J Pain. 2006 Apr;10(3):209-17. doi: 10.1016/j.ejpain.2005.03.008.
Clinical trial NCT03534271: The Accuracy of Smartphone Pulse Oximetry in Patients Visiting an Outpatient Pulmonary Function Lab for a 6-Minute Walk Test
Official title: The Accuracy of Smartphone Pulse Oximetry in Patients Visiting an Outpatient Pulmonary Function Lab for a 6-Minute Walk Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oximetry
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2018-05-23
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients visiting a pulmonary function lab for 6-minute walk test

Brief summary: The primary aim of this research is to determine the accuracy of smartphone pulse oximeters in detecting blood oxygen saturations, episodes of desaturations, and heart rate by comparing results to a Masimo© hospital-grade pulse oximeter.


Eligibility criteria: Inclusion Criteria:

* Ambulatory
* 18 years and older
* Visiting the pulmonary function laboratory at Rush University Medical Center for a 6-minute walk test that agree to participate.

Exclusion Criteria:

* Under the age of 18 years
* High blood pressure above 180/90 mm Hg or pressure below 70/50 mm Hg
* Dizzy, lightheaded or have severe headaches at time of enrollment
* SpO2 at or below 85% on supplemental oxygen
* On oxygen greater than 4 liters per minute
* Gait issues that may result in a fall or patient walks with a walker and did not bring the device to this visit

Primary outcomes:
measure: Accuracy of Smartphone Pulse Oximeters
timeFrame: immediately after the 6 minute walk test
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References:
citation: Modi AM, Kiourkas RD, Li J, Scott JB. Reliability of Smartphone Pulse Oximetry in Subjects at Risk for Hypoxemia. Respir Care. 2021 Mar;66(3):384-390. doi: 10.4187/respcare.07670. Epub 2020 Oct 6.
Clinical trial NCT03833271: The Efficacy of Influenza Vaccine Program in Children With Juvenile Idiopathic Arthritis. A Single Centre Results From Hungary
Official title: The Investigation of Immune Function and the Effectiveness of Influenza Vaccine in Children With Juvenile Idiopathic Arthritis Compared to Healthy Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Juvenile Idiopathic Arthritis
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 62
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of our study is to compare the immune function of patient treated with DMARD (methotrexate), or tumor necrosis factor (TNF)-alpha inhibitor (adalimumab) to healthy children. The study consists of three parts. In each part physical examination and routine laboratory tests are done.

At the first examination flow cytometry analysis is performed, after that the participants are immunized with influenza (3Fluart) vaccine. At part two and three further flow cytometry is carried out and seroconversion is measured.


Eligibility criteria: Inclusion Criteria:

* JIA (oligoarticular, polyarticular) treated with MTX or MTX/adalimumab
* Healthy controls

Exclusion Criteria:

* Children with infection
* Children with active JIA disease
* JIA other than oligoarticular, polyarticular type

Primary outcomes:
measure: Comparing the healthy population and the JIA participants treated with DMARD (MTX) or TNF-alpha inhibitor (adalimumab)
timeFrame: 12-14 weeks
measure: Immune response to influenza vaccine, the rate of seroconversion
timeFrame: 12-14 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Pécs
country: Hungary
facility: University of Pécs, Medical School, Department of Paediatrics
Study officials:
References:
citation: Nagy A, Mosdosi B, Simon D, Dergez T, Berki T. Peripheral Blood Lymphocyte Analysis in Oligo- and Polyarticular Juvenile Idiopathic Arthritis Patients Receiving Methotrexate or Adalimumab Therapy: A Cross-Sectional Study. Front Pediatr. 2020 Dec 10;8:614354. doi: 10.3389/fped.2020.614354. eCollection 2020.
Clinical trial NCT04827771: The Impact of the Biologist Performing the Embryo Transfer on the Cycle Outcome
Official title: Different Actors for the Same Play: the Impact of the Biologist Performing the Embryo Transfer on the Cycle Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 30000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All the fresh, IOC (insemination of in vitro matured oocytes) and frozen embryo transfer performed between January 2000 and December 2019 at Humanitas Fertility Center.

A total of 28 biologist operators were eligible to participate in the study.

Brief summary: This is a retrospective single center analysis which includes all the fresh, IOC (insemination of in vitro matured oocytes) and frozen embryo transfer (ET) performed between January 2000 and December 2019 at Humanitas Fertility Center after IVF-ICSI (In Vitro Fertilization - Intracytoplasmic Sperm Injection) cycles.

The primary objective is to determine the impact of the biologist performing the embryo transfer on the pregnancy probability, in terms of ongoing pregnancy rate (OPR), defined as the number of viable pregnancies that had completed at least 12 weeks of gestation on the total number of ET performed.

Secondary end point is to evaluate whether the biologists improve their performances as their experience increases, allowing the drawing of an ET learning curve in term of pregnancies for the different biologists.

The biologist's experience was assessed in terms of number of previous interventions performed prior to the day of ET. A total of 28 operators were eligible to participate in the study. Any biologists who performed less than 100 ETs was excluded from the analysis.


Eligibility criteria: Inclusion criteria:

Exclusion Criteria:

Any biologist who performed less than 100 embryo transfers was excluded from the analysis.

Primary outcomes:
measure: Ongoing pregnancy rate
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Li H, Li L, Lu X, Sun X, Ng EHY. Comparison of the effect of immediate versus delayed transfer following a stimulated IVF cycle on the ongoing pregnancy rate of frozen-thawed embryo transfer cycles: a study protocol for a randomised controlled trial. BMJ Open. 2018 May 17;8(5):e020507. doi: 10.1136/bmjopen-2017-020507.
Clinical trial NCT03912571: Sleep Disordered Breathing and Alzheimer's Disease Biomarkers in Normal Aging and Mild Cognitive Impairment
Official title: Sleep Disordered Breathing and Alzheimer's Disease Biomarkers in Normal Aging and Mild Cognitive Impairment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Disorder
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-04-11
Enrollment: 28
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 80 cognitively healthy subjects (normal or MCI) previously enrolled in Alzheimer's Disease Core Center (ADCC) and CBH studies who have agreed to be contacted about future research studies will be asked to additionally participate in this study. The age range of the subjects will be of 55-90 years based on the incidence of dementia in middle age and elder adults.

Brief summary: The purpose of this study is to determine the sleep patterns of subjects with or without sleep disturbances (insomnia, sleep apnea) and compare these findings with their previous FDG/PIB PET, structural MRI and brain blood flow scams performed during their participation in the Following studies 'Alzheimer's Disease Core Center (ADCC) Clinical Evaluation' (IRB: 2942), MRI Progression Markers of Cognitive Decline in the Elderly' (IRB:09-0586), or 'Imaging Neuro inflammation in Alzheimer's Disease with \[11C\] Arachidonic Acid (AA) and PET'(IRB: 10-00442).


Eligibility criteria: Inclusion Criteria:

* All subjects will have participated in prior CBH studies and have agreed to an FDG, PIB and MRI scans.

Exclusion Criteria:

* Diagnosis of sleep apnea and under treatment with a continuous positive airway pressure (CPAP) machine.
* Active depressive episode during the evaluation with a Geriatric Depression Scale score \>7 and/or a Clinical Global Impression scale for depression score \>4.
* Moderate Cognitive decline (GDS \>3).
* Severe primary or secondary insomnia except insomnia due to SDB.

Primary outcomes:
measure: Decreased cerebral blood flow (CBF)
timeFrame: 1 Week
measure: Measure of vasoreactivity to CO2 (VRCO2)
timeFrame: 1 Week
measure: Increase in cortical AB plaque burden
timeFrame: 1 Week
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Ricardo Osorio, MD
role: PRINCIPAL_INVESTIGATOR
References: