louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02036866: Corticospinal Excitability and Rehab in Knee Osteoarthritis
Official title: Corticospinal Excitability and Rehab in Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: knee osteoarthritis
grade I and II knee osteoarthritis
arthritis
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2014-01-15
Enrollment: 61
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine differences in thigh muscle function in individuals with and without knee arthritis, and also determine the effectiveness of common physical therapy interventions on clinical and patient oriented outcomes.

Detailed description: The primary objective of the proposed research evaluates the concurrent changes in corticospinal excitability and central sensitization of pain pathways for their influence on quadriceps voluntary activation. A secondary objective is to establish the feasibility of an intervention study to determine if changes in the excitability of these supraspinal motor and sensory processes can be modified by physical therapy interventions targeting pain and muscle strengthening. We hypothesize that patients with knee osteoarthritis will show measurable deficits in quadriceps voluntary activation that can be explained by lower levels of corticospinal excitability and increased pain sensitization. A 1 week physical therapy intervention will improve voluntary activation and reduce pain with concurrent changes in underlying motor and sensory processes. We further hypothesize that part of this improvement will be attributed to positive treatment expectation.

Eligibility criteria: Inclusion Criteria:

* Age 19-65
* Grade I or II knee Osteoarthritis confirmed by radiographs or other imaging and at least one of the following:

  * Age \> 50 years old
  * Morning stiffness \< 30 minutes
  * Crepitus
* Meet at least 3 of 6 diagnostic criteria for osteoarthritis:

  * Age \> 50 years old
  * Morning stiffness \< 30 minutes
  * Crepitus
  * Bony tenderness
  * Bony enlargement
  * No palpable warmth

Exclusion Criteria:

* BMI \> 30
* History of traumatic spine or lower extremity injury within the last 6 months
* Previous adverse reaction to electrical stimulation (i.e. burns or hypersensitivity)
* Cardiac pacemaker
* Metal implants in head
* Current pregnancy
* Neurological disorders
* History of seizures
* Unable to give consent or understand the procedures of this study

Primary outcomes:
measure: Change in quadriceps force output and voluntary activation
timeFrame: Baseline and following 1 week intervention (2 Study Visits)
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
Study officials:
affiliation: Creighton University
name: Terry L Grindstaff, PhD, PT, ATC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00951366: Preterm Lung Patient Registry
Official title: Preterm Lung Patient Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bronchopulmonary Disease
Keywords: premature birth
neonatal respiratory distress
chronic lung disease
epidemiologicfactors
genetic factors
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2009-08-04
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Former preterm infants

Brief summary: The goal of the Preterm Lung Patient Registry is to collect data on individuals with neonatal lung disease to better understand the illness and ultimately improve their care and survival. The Patient Registry was established in 2008 as a means to monitor important trends in the BPD population and to improve understanding, treatment, and survival.

Detailed description: The Preterm Lung Patient Registry is an observational study designed to identify epidemiologic and genetic factors associated with chronic lung disease in former preterm infants or those with lung disease in the neonatal period. The Patient Registry is used by both clinicians and researchers to better understand BPD and to improve care of individuals with BPD. It is used to assess phenotype and genotype information from former preterm infants with lung disease. Data in the Patient Registry will be analyzed and an regular report of BPD health trends will be created. Using this information, BPD clinicians can address quality improvement initiatives, and examine changing health care issues, including nutritional status, infection control, pulmonary treatment, metabolic and associated genetic variants. The Patient Registry will also play an important role in directing clinical care and in the design of clinical research studies. Researchers use the registry to help in investigating various aspects of neonatal lung diseases like BPD, including medications, diagnostic procedures, and eligibility for clinical trials.

Eligibility criteria: Inclusion Criteria:

* Former preterm infant

Primary outcomes:
measure: Lung function
timeFrame: Lifetime
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
References:
citation: Annesi CA, Levin JC, Litt JS, Sheils CA, Hayden LP. Long-term respiratory and developmental outcomes in children with bronchopulmonary dysplasia and history of tracheostomy. J Perinatol. 2021 Nov;41(11):2645-2650. doi: 10.1038/s41372-021-01144-0. Epub 2021 Jul 21.
citation: Levin JC, Sheils CA, Gaffin JM, Hersh CP, Rhein LM, Hayden LP. Lung function trajectories in children with post-prematurity respiratory disease: identifying risk factors for abnormal growth. Respir Res. 2021 May 10;22(1):143. doi: 10.1186/s12931-021-01720-0.
Clinical trial NCT01221766: Impact of Adnexal Involvement of the Severity and Prognosis of Chronic Graft-versus-Host Disease
Official title: The Impact of Adnexal Involvement of the Severity and Prognosis of Chronic Graft-versus-Host Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Graft vs Host Disease
Chronic Graft vs Host Disease
cGVHD
Keywords: adnexal
hair and nail
chronic graft vs host disease
children
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2010-10-15
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The research subject population is children who have received hematopoietic stem cell transplant and developed chronic graft-versus-host disease. All children seen at the pediatric GVHD clinic at the Dana-Farber Cancer Institute will be recruited.

Brief summary: This research study will help us learn more about how chronic graft-versus-host disease affects the skin, hair and nails. We are interested in knowing if hair and nail problems predict worse disease. This information may help us treat patients like you in the future.

Detailed description: * At the initial visit, participants will have a complete examination of their skin, hair and nails. We will also test muscle strength and movement by moving the participant's arms, legs and neck. Photographs will be taken of the skin, hair and nails of they are abnormal. Blood tests will be done to check the liver and blood cell count. The participant and their legal guardian will answer questions about how the participant feels and about their health.
* Participants will then be scheduled for follow up visits at 3 months, 6 months, and 12 months. At each subsequent visit the following will be done: A complete examination of the skin, hair and nails; a test of muscle strength; photographs will be repeated; blood tests to check liver and blood cell counts; and questions about how the participant feels and about their health.

Eligibility criteria: Inclusion Criteria:

* Received hematopoietic stem cell transplant
* Meet the diagnostic criteria for cutaneous cGVHD

Exclusion Criteria:

* Previous HSCT (other then the current HSCT)

Primary outcomes:
measure: Adnexal involvement
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Jennifer Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05666466: Noninvasive Diagnostic Techniques in Determination of Site of Lesion of Auditory Neuropathy Spectrum Disorder
Official title: Noninvasive Diagnostic Techniques in Determination of Site of Lesion of Auditory Neuropathy Spectrum Disorder(ANSD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Auditory Neuropathy
Keywords: auditory neuropathy
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 25
Sex: ALL
Minimum age (years): 12
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 25 participants aged between 12 to 50 years old with disproportionate SRS to PTA level, ABR may be absent or with disturbed waves or wave 5 could be detected at high intense stimulus, OAE and CM could be present. CT and MRI are free

Brief summary: cross-sectional study of population who have ANSD

Detailed description: Cross-sectional nonivasive study including study and control group aiming to determine site of lesion of auditory neuropathy spectrum disorder either presynaptic or postsynaptic by using electrophysiological measures

Eligibility criteria: Inclusion Criteria:

* Age between 12 and 50 years OAE and CM could be present disproportionate SRS to PTA level

Exclusion Criteria:

proportionate ABR to PTA level Proportionate SRS to PTA level

* presnce ol lesions in CT or MRI

Primary outcomes:
measure: determination of site of lesion of ANSD
timeFrame: one and half year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag Faculty of Medicine
Study officials:
References:
Clinical trial NCT02784366: GI Complications in Cancer Immunotherapy Patients
Official title: GI Complications in Cancer Immunotherapy Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malignant Melanoma
Keywords: Cancer immunotherapy
Ipilimumab
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
First posted: 2016-05-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of cancer who have undergone or will be undergoing immunotherapy will be eligible for recruitment.

Brief summary: The purpose of this study is to establish a prospective observational cohort of cancer immunotherapy patients with GI side effects in order to identify biomarkers that predict GI complications due to treatment.

Detailed description: Primary objective

* To create a data and bio-specimen repository to enhance both safety and efficacy of immunotherapy

Secondary objective

* Identify biomarkers that may predict GI toxicity in cancer patients undergoing immunotherapy
* Define the clinical course of intestinal inflammation and identify genetic factors of therapeutic response to GI medications
* Analyze genotype-phenotype correlations in GI side effects in patients undergoing cancer immunotherapy

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of cancer
* Currently undergoing or have undergone immunotherapy

Exclusion Criteria:

* History of a total colectomy
* History of inflammatory bowel disease (either ulcerative colitis or Crohn's disease)
* History of colitis on chemotherapy

Primary outcomes:
measure: GI disease activity
timeFrame: 12 weeks
measure: Biospecimen collection
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Michael Dougan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Ryan J Sullivan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04068766: Efficacy of Paracervical Block in Laparoscopic Myomectomy: a Randomized Controlled Trial (PALM)
Official title: Efficacy of Paracervical Block in Laparoscopic Myomectomy: a Randomized Controlled Trial (PALM)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Uterine Fibroid
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 62
Sex: FEMALE
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: It remains controversial whether paracervical block should be performed as a powerful strategy for pain relief in laparoscopic myomectomy (LM), because convincing conclusions are difficult to draw because of the heterogeneous and contradictory nature of the literature. Therefore, the aim of this study was to evaluate the efficacy of paracervical blocks using with 0.5% bupivacaine prior to LM for benign gynecologic conditions on postoperative pain relief.

Detailed description: However, no study investigating the efficacy of paracervical block in laparoscopic myomectomy on postoperative pain was conducted, to date. Therefore, the goal of this study is to evaluate whether patients who receive a paracervical block of 5% bupivacaine with epinephrine at the time of laparoscopic myomectomy would have lower postoperative pain, with less consumption of rescue analgesics than patients who receive a paracervical block of normal saline.

Eligibility criteria: Inclusion Criteria:

* Uterine myoma
* American Society of Anesthesiologists physical status (ASAPS) classification I-II
* The absence of pregnancy at the time of surgery.

Exclusion Criteria:

* history of cervical surgery such as conization or cerclage
* inability to perform the paracervical block due to anatomical abnormalities (i.e., very atrophic or small cervix)
* allergy to bupivacaine, planned concomitant surgical procedures involving extensive additional tissue manipulation such as pelvic lymph node dissection
* any concomitant surgery of pelvic floor repair (uterosacral ligament suspension or sacrocolpopexy) or vaginal procedure (anterior or posterior colporrhaphy or mid-urethral slings)
* previously taking opioids for chronic pain
* inability to accurately express their pain

Primary outcomes:
measure: Postoperative pain
timeFrame: at 6-hour after surgery
Secondary outcomes:
measure: Frequency of pills/injections requested
timeFrame: Within 24-hour after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
Study officials:
affiliation: Kangbuk Samsung Hospital
name: Taejong Song
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01433666: Roflumilast and Cognition
Official title: Effects of Roflumilast on Cognition in Healthy Adults: a Behaviour-EEG Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dementia
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2011-09-14
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the current project is to validate PDE4 inhibitors as a target for cognition enhancers (proof-of-concept) using a translational behaviour-EEG approach. The project will demonstrate whether memory, but also attention, information processing or executive function improves with the PDE4 inhibitor roflumilast in healthy humans.


Eligibility criteria: Inclusion Criteria:

* 18 to 35 years of age
* Healthy (i.e. absence of all exclusion criteria), normal static binocular acuity (corrected or uncorrected),
* Body mass index between 18.5 and 30
* Willingness to sign an informed consent.
* Positive evaluation on the memory screening

Exclusion Criteria:

* History of cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal, haematological, or psychiatric illness
* First-degree relative with psychiatric disorder (in particular major depressive disorder and suicidality)
* Excessive drinking (\>20 glasses of alcohol containing beverages per week)
* Pregnancy or lactation
* Use of chronic medication other than oral contraceptives
* Use of recreational drugs in the 2 weeks preceding participation
* Smoking
* Orthostatic hypotension
* Lactose intolerance
* Sensory or motor deficits which could reasonably be expected to affect test performance

Primary outcomes:
measure: Number of words remembered on Verbal learning task
timeFrame: 1hr after drug intake
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University, Faculty of Psychology and Neuroscience
state: Limburg
Study officials:
affiliation: Maastricht University
name: Jos H. Prickaerts, PhD
role: STUDY_DIRECTOR
References:
citation: Heckman PRA, Van Duinen MA, Blokland A, Uz T, Prickaerts J, Sambeth A. Acute administration of roflumilast enhances sensory gating in healthy young humans in a randomized trial. Psychopharmacology (Berl). 2018 Jan;235(1):301-308. doi: 10.1007/s00213-017-4770-y. Epub 2017 Nov 3.
citation: Van Duinen MA, Sambeth A, Heckman PRA, Smit S, Tsai M, Lahu G, Uz T, Blokland A, Prickaerts J. Acute administration of roflumilast enhances immediate recall of verbal word memory in healthy young adults. Neuropharmacology. 2018 Mar 15;131:31-38. doi: 10.1016/j.neuropharm.2017.12.019. Epub 2017 Dec 11.
Clinical trial NCT04983966: Comparison of Postoperative QoR-15 Scores Between Desflurane and Remimazolam in Lumbar Fusion Surgery
Official title: Comparison of Quality of Recovery (QoR)-15 Scores According to the Anesthetics (Desflurane vs. Remimazolam) in the Patients With Lumbar Fusion Surgery: a Prospective Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Fusion Surgery
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 76
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of the study is to compare the quality of recovery (QoR)-15 scores according to the use of maintenance anesthetics in the lumbar fusion surgery. Total intravenous anesthesia (TIVA) have been known to help reducing risks of postoperative nausea/vomiting and malignant hyperthermia. However, it is still not enough to explain which is better between TIVA or inhalation anesthesia. In particular, there is no study to investigate overall postoperative functional recovery via QoR-15 in patients receiving TIVA with remimazolam. The hypothesis of our study is that total intravenous anesthesia based on remimazolam will demonstrate better quality of recovery compared with the anesthesia based on inhalation using desflurane.


Eligibility criteria: Inclusion Criteria:

- Adult patients who aged 20-70 years with ASA-PS 1-3, BMI \<30 undergoing lumbar fusion surgery under general anesthesia

Exclusion Criteria:

* Tolerance or hypersensitivity to benzodiazepine or propofol
* Dependence or addiction to psychotropic drugs or alcohol
* Pregnant women
* subjects who lack the ability to make decisions and susceptible to voluntary participation decisions

Primary outcomes:
measure: The difference of QoR-15 scores
timeFrame: postoperative day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GangnamSeverance Hospital
Study officials:
References:
Clinical trial NCT04408066: COVID-19: A POC Test Under Research & Evaluation
Official title: Specimen Collection for Development and Performance Evaluation of the LumiraDx Platform Point of Care Tests for Sars-Cov-2 IgG/IgM & Antigen to be Used as an Aid in Diagnosis of COVID-19
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: COVID-19
Keywords: POC
IVD
SARS-CoV-2
IgG
IgM
Antigen
Antibody
Lead sponsor: LumiraDx UK Limited
Sponsor class: INDUSTRY
First posted: 2020-05-29
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Sample Collection \& Performance Evaluation Study.
Primary purpose: DIAGNOSTIC

Brief summary: Collection of nasal/nasopharyngeal/throat swabs and blood samples from patients presenting at their designated care facility displaying symptoms of COVID-19 and undergoing a SOC SARS-CoV-2 test or those who have tested positive in the past to aid development, calibration and performance evaluation for the LumiraDx POC test.

Detailed description: CAPTURE is a two-stage sample collection study to complete the development, calibration and performance evaluation phases of the LumiraDx Point of Care (POC) device for the detection of the SARS-CoV-2 virus and the SARS-CoV-2 IgG/IgM status of infected patients. The study is split into two arms targeting separate populations throughout each stage.

Stage 1: Consists of sample collection only, to facilitate the in-house development and calibration of the LumiraDx SARS-CoV-2 assays.

Stage 2: Consists of sample collection to facilitate the performance evaluation of the LumiraDx SARS-CoV-2 studies. In this stage the testing will be completed onsite using the LumiraDx POC device.

Eligibility criteria: Inclusion Criteria:

1. Patient is at least 18 years of age.
2. Patient meets either of the below categories:

   1. Patient is presenting with symptoms indicative of COVID-19 and will be completing SOC sampling for SARS-CoV-2 PCR testing. (Eligible for Arm A)
   2. Patient has had a confirmed positive SARS-CoV-2 PCR test result in the past. (Eligible for Arm B)

Exclusion Criteria:

1. The patient does not have the capacity to consent as determined by the Research Team (and the impartial witness if applicable).
2. The patient is deemed to be unsuitable for research at the research teams' discretion.

Primary outcomes:
measure: Performance of the LumiraDx Assay versus reference methods with regards to clinical sensitivity and specificity for the detection of the SARS-COV-2 IgG/IgM and viral antigen in patient samples.
timeFrame: 1 Year approx
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Barts Health NHS Trust
city: London
country: United Kingdom
facility: Homerton University Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust
Study officials:
affiliation: University College London Hospitals
name: Samer Elkhodair
role: PRINCIPAL_INVESTIGATOR
References: