cyrilzakka/clinical-trials huggingface dataset:
Virtual Reality Trial Using EaseVRx For Chronic Low Back Pain

Randomized, 2-arm parallel group clinical trial evaluating the effectiveness of a self-administered Virtual Reality program for the treatment of chronic lower back pain compared to a placebo VR program.

A randomized, 2-arm parallel-group clinical trial evaluating the effectiveness of a self-administered Virtual Reality (VR) program for the treatment of chronic lower back pain. The primary objective of this study is to assess the impact of skills-based VR on changes in patient-reported pain and pain interference over the course of an 8-week intervention as well as compared to a placebo VR condition. The secondary objective is to assess the impact of skill-based VR on changes in patient-reported satisfaction over the course of an 8-week intervention and compared to a placebo VR condition. A tertiary objective is to assess the impact of skills-based VR on changes in patient-reported opioid use, physical function, behavioral skills development, and health outcomes immediately following the intervention relative to a pre-intervention baseline and compared to a placebo VR condition. An exploratory objective is to assess the impact of skills-based VR on changes in patient-reported pain levels, opioid use, physical function, behavioral skills development, health outcomes, and satisfaction at the 24-week post-intervention time point and compared to a placebo VR condition.

Eligibility Criteria:
Inclusion Criteria:

* Men and women 18-85 years old
* Diagnosis of low back pain without radicular symptoms
* Pain duration of at least 6 months
* Average pain intensity of at least 4 on the 0-10 DoD/VA Pain Scale for the past month at screening
* English fluency
* Willing to comply with study procedures/restrictions

Exclusion Criteria:

* Unable to understand the goals of the study due to cognitive difficulty
* Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines or other neurological disease that may prevent the use of VR
* Medical condition predisposing to nausea or dizziness
* Hypersensitivity to flashing light or motion
* No stereoscopic vision or severe hearing impairment
* Injury to eyes, face or neck that prevents comfortable use of VR
* Pain related to cancer
* Active suicidal ideation or severe depression
* Previous use of EaseVR for pain
* Current participation in any interventional research study or completed participation in past 2 months
* Currently pregnant or planning to become pregnant
* Does not have access to WIFI during participation in study
* Currently works at or has an immediate family member who works for a digital health company or pharmaceutical company that provides treatments for acute or chronic pain
A Study to Isolate and Test Circulating Tumor Cells Using the ClearCell® FX EP+ System

The purpose of this study is to isolate and measure circulating tumor cells in the blood stream to advance detection of cancer and treatment monitoring. In this study, the investigators will utilize the novel technology for circulating tumor cell detection in order to evaluate their presence in patients with lung cancer.

The plan is to collect both blood and tumor samples from the patient's lung cancer in order to validate this technology in detecting circulating tumor cells. The investigators will also obtain a postoperative blood sample to see if there is a decrease in the overall circulating tumor cell measurement once the tumor has been surgically removed.

Eligibility Criteria:
Inclusion Criteria:

* Stage IB and above non-small cell lung cancer or metastatic lung cancer
* Age \>18 years old
* Willing and able to consent to study
* No prior history of neoadjuvant therapy.

Exclusion Criteria:

* Age \<18 years old
* Unable to provide consent
Uterus Transplantation LD - Feasibility Study - Sahlgrenska - BMC

Medical know-how concerning uterus transplantation will be transferred to new site by structured process involving theory, animal workshops and a clinical feasibility study on human subjects.

Medical know-how concerning uterus transplantation will be transferred to new site by structured process involving theory, animal workshops and surgery.

Theory and common animal workshops have been ongoing for 3 years. The team from Bellevue Medical Centre is affiliated to St Joseph, University, Beirut

Eligibility Criteria:
Inclusion criteria recipient

* age \< 38 years
* psychologicaly stable
* BMI \< 35
* no systemic disease
* no standing medication
* in a stable relationship or married
* normal ovarian reserve
* absolute uterine factor infertility
* normal kidney function

Inclusion criteria donor

* close relative to recipient
* age \< 60 years
* normal pregnancies
* maximum two cesarean sections
* BMI \< 35
* no major systemic disease
* no previous major surgery
A Relative Bioavailability Study and Food Effect Study of AB521 in Healthy Adult Volunteers

The primary purpose of this study is to compare the single-dose pharmacokinetics (PK) of casdatifan tablet versus the casdatifan capsule, and to evaluate the effect of food on the single-dose PK of casdatifan tablet in healthy adult volunteers.


Eligibility Criteria:
Key Inclusion Criteria:

* Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on volunteer self-reporting
* Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilogram (kg)/square meter (m\^2) at the screening visit, with body weight ≥ 45 kg
* Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, and ECGs, as deemed by the study physician
* Able to swallow multiple capsules and tablets
* Has adequate peripheral venous access

Key Exclusion Criteria:

* Has active neoplastic disease or history of neoplastic disease within 5 years of the screening visit (except for basal or squamous cell carcinoma of the skin or carcinoma in situ that has been definitively treated with standard of care)
* Has abnormal liver enzyme test results or hematology values at the time of enrollment
* Has a history of additional risk factors for Torsades de pointes (example: heart failure, hypokalemia, family history of Long QT Syndrome)
* Malabsorption condition that would alter the absorption of orally administered medications at the discretion of the study physician
* Participation in another clinical study within 90 days or within 5 half-lives (if known), prior to the first dosing, whichever is longer. The 90-day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of the current study

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Endothelial Dysfunction Evaluation for Coronary Heart Disease Risk Estimation in Rheumatoid Arthritis (EDRA Study)

To evaluate the contribution of the assessment of endothelial dysfunction (ED) in improving coronary hearth disease (CHD) risk stratification obtained by the Framingham risk score (FRS) in rheumatoid arthritis population (RA).

ED, determined by peripheral arterial tonometry (PAT), will be evaluated at baseline in 3000 RA patients free of previous cardiovascular events. Incident CHD events during the 3-year planned follow-up will be registered. A measure of the incremental yield of ED will be obtained comparing 2-year Framingham risk score for CHD (FRS) and FRS plus ED differential prognostic performances by C-statics and risk reclassification analysis.

Eligibility Criteria:
Inclusion Criteria:

* RA as defined by American College of Rheumatology/European League Against Rheumatisms 2010 RA classification criteria
* In the opinion of investigators, patients must be able to adhere to the study visit schedule and must be capable of giving informed consent

Exclusion Criteria:

* Previous cardiovascular or cerebrovascular events (acute coronary syndrome, stable angina, stroke, interventional procedures, carotid endarterectomy, symptomatic peripheral artery ischemia)
* Pathological ECG at rest
* Sign or symptoms of autonomous nervous system dysfunction
* Serious infections in the previous 6 months
* Concomitant severe illness: overt hepatic insufficiency; End stage renal disease (Glomerular Filtration Rate \<30 ml/h at Cockrofts-Gault formula); recent diagnosis of cancer
* Pregnancy
* Plans to leave target areas of each study site within three years
Confocal Laser Microscopy in Non Erosive Reflux Disease

Heartburn or reflux disease affects about 20% of Americans. 50 - 70% of people who have endoscopy for reflux disease have a normal appearing esophagus. Confocal Laser Microscopy allows us to see changes in the cells not visable during routine endoscopy. Whe goal of this study is to identify the use of this new technique in diagnosing reflux in patients who have normal appearing esophagus.

Gastroesophageal reflux disease (GERD) remains a major problem in the United States affecting about 20% of Americans. Upper endoscopy (EGD) is commonly used to diagnose and grade GERD based on mucosal breaks and erosions. It is now evident from multiple studies however that the majority of GERD patients (50-70%) have negative EGDs.These patients are refered to as "Non Erosive Reflux Disease" (NERD) patients.Confocal Laser Microscopy (CLM) is a new endoscopic technique that offers the advantage of detecting histologic changes during real time endoscopy and thus can diagnose NERD. We thus propose to study the sensitivity and specificity of CLM in predicting NERD. We hypothesize that CLM can reliably diagnose NERD in the appropriate clinical setting based on intrapapillary capillary loop patterns. This will be a pilot study after which a randomized trial will evaluate the reversibility of these changes after PPI therapy as seen by CLM

Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 years to 85 years old who are referred for an upper endoscopy for symptoms of reflux disease
2. Patients who are able to give informed consent

Exclusion Criteria:

1. Patients with a history of Erosive esophagitis
2. Patients with a history of Barrett's esophagus
3. Patients who on upper endoscopy have any current evidence of erosive esophagitis, Barrett's esophagus or varices
4. Patients who are unable or unwilling to undergo endoscopic evaluation
5. Patients who are unable to give informed consent
6. Patients with a known coagulopathy who are unable to be off therapy
Study of Itacitinib in Combination With Corticosteroids for the Treatment of Acute GVHD

To determine if Itacitinib in combination with corticosteroids is safe and tolerable in patients with Grade IIB-IVD acute graft-versus-host disease (GVHD).


Eligibility Criteria:
Inclusion Criteria:

* Have undergone first allo-HSCT from any donor source (matched unrelated donor, sibling, haploidentical) using bone marrow, peripheral blood stem cells, or cord blood for hematologic malignancies. Recipients of nonmyeloablative and myeloablative transplants are eligible.
* Clinically suspected Grades IIB to IVD acute GVHD as per modified MN-CIBMTR criteria, occurring after allo-HSCT with any conditioning regimen and any anti-GVHD prophylactic program.
* Subjects may, but are not required to, have previously received corticosteroids for acute GVHD:
* Evidence of myeloid engraftment. Use of growth factor supplementation is allowed.

Exclusion Criteria:

* Has received more than 1 hematopoietic stem cell transplantation.
* Has progressed on more than 2 prior treatment regimens for acute GVHD.
* Presence of an active uncontrolled infection.
* Subjects with relapsed primary disease, or subjects who have been treated for relapse after the allogeneic hematopoietic stem-cell transplantation (allo-HSCT) was performed.
* Inadequate recovery from toxicity and/or complications from the prior allo-HSCT.
* Any corticosteroid therapy (for indications other than GVHD) at doses \> 1 mg/kg per day methylprednisolone or equivalent within 7 days of randomization.
* Previously received JAK inhibitor therapy for any indication.
BTT-1023 in Rheumatoid Arthritis

Patients with adult-onset rheumatoid arthritis will be enrolled. They will be dosed with repeated intravenous doses of BTT-1023 or placebo. During the trial, the safety of the treatments and the pharmacokinetics of BTT-1023 will be assessed. The patient allocation to treatment groups will occur at random, and the actual treatment will not be revealed to the investigator or to the patient during the trial.


Eligibility Criteria:
Inclusion Criteria:

* adult-onset rheumatoid arthritis

Exclusion Criteria:

-
Study to Assess the Metabolism, Excretion and Pharmacokinetics of [14C]AZD1981 in Healthy Male Volunteers

The purpose of the study is to characterize the absorption, distribution, metabolism and excretion (ADME) of a single oral dose of \[14C\]AZD1981


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed, written and dated informed consent prior to any study specific procedure
* Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg

Exclusion Criteria:

* Exposed to radiation levels above background of \>5 mSv in the last year, \>10 mSv over the last 5 years or a cumulative total of \>1 mSv per year of life
* History or presence of any clinically significant disease or disorder in the opinion of the investigator
* Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator
Study of Abrocitinib Compared With Dupilumab in Adults With Moderate to Severe Atopic Dermatitis on Background Topical Therapy

This is a randomized, double-blind, double-dummy, active-controlled, multi-center study to assess the efficacy and safety of abrocitinib 200 mg (2 x 100 mg tablets) administered orally QD compared with dupilumab 300 mg administered by subcutaneous injection every other week (as per label guidelines) in adult participants on background topical therapy, with moderate to severe AD. The treatment duration is 26 weeks. A total of approximately 600 participants will be enrolled from approximately 220 sites globally. Approximately 600 participants will be randomly assigned to study intervention. There are primary efficacy assessments at Week 2 and Week 4, and a key secondary efficacy assessment at Week 16. Efficacy and safety endpoints will be assessed throughout the entire study. Exploratory endpoints related to hand eczema efficacy will be assessed throughout the study.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Diagnosis of chronic atopic dermatitis (AD) for at least 6 months
* Moderate to severe AD (BSA at least 10%, IGA at least 3, EASI at least 16, and PP-NRS severity score at least 4)
* Recent history of inadequate response to treatment with medicated topical therapy for AD, or who have required systemic therapies for control of their disease

Exclusion Criteria:

* Acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation
* Have increased risk of developing venous thromboembolism
* Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
* Prior treatment with systemic JAK inhibitors or IL-4 or IL-13 antagonists including dupilumab, lebrikizumab or tralokinumab
* Other active non-AD inflammatory skin diseases or conditions affecting skin
* Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, malignancies, current or history of certain infections, lymphoproliferative disorders and other medical conditions at the discretion of the investigator
* Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception
Prognostic Biomarkers in Tumor Tissue Samples From Young Patients With Neuroblastoma

This research study is studying biomarkers in tumor tissue samples from young patients with neuroblastoma. Studying samples of tissue from patients with cancer in the laboratory may help doctors identify biomarkers and learn more about biomarkers related to cancer

PRIMARY OBJECTIVES:

I. Determine whether ubiquitin carboxyl-terminal hydrolase 1 (UCHL1) expression is an indirect cancer stem cell marker in pediatric patients with neuroblastoma. Correlate UCHL1 expression with staging information and patient's outcome.

Study Subtype: Observational Observational Study Model: Case-control Time Perspective: Retrospective Biospecimen Retention: None Retained Biospecimen Description: Tissue Study Population Description: Tissue microarray samples from patients with Neuroblastoma supplied by the COG Biopathology Center Sampling Method: Probability

OUTLINE:

Archived tissue microarray samples are analyzed for ubiquitin carboxyl-terminal hydrolase 1 (UCHL1) expression by UCHL1 monoclonal antibody and peroxidase technique. Results are then compared with patients' clinical data, including age at diagnosis, race, date of diagnosis, histology, stage and location at diagnosis, presence of cancer predisposition, date of completion of treatment, surgery performed, type of chemotherapy received, history of recurrence, and status (alive with disease, alive without disease, dead), if available.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with neuroblastoma
* Tissue microarrays containing normal and neuroblastoma samples provided by the Children's Oncology Group (COG) Biopathology Center
Lumigan Versus Cosopt

To compare the intraocular pressure effect and safety of the dorzolamide/timolol fixed combination given twice daily versus bimatoprost given once every evening in patients with open-angle glaucoma in patients insufficiently controlled on latanoprost monotherapy


Eligibility Criteria:
Inclusion Criteria:

* adults with a diagnosis of bilateral open-angle glaucoma including: primary, pigment dispersion or exfoliation in both eyes
* on no therapy the intraocular pressure should be 22-29 mm Hg inclusive at the 8:00 AM measurement
* visual acuity should be 20/200 or better in each eye

Exclusion Criteria:

* historical failure to respond to topical beta-blockers in a clinically meaningful manner
* any contraindication to study medications
* any anticipated change, or modification in the 6 weeks prior to Visit 1, in systemic hypertensive therapy during the trial
Evaluation of EMI in Patients With Micra Leadless Pacemaker

Subjects with Medtronic Micra leadless pacemaker who require surgical procedures will have postoperative interrogations reviewed for evidence of electromagnetic interference (EMI).

Patients with pacemakers have a potential risk of EMI from sources including electrosurgery which can cause oversensing, pacing inhibition and device reset. There is limited data on surgical EMI in Medtronic Micra leadless pacemakers. The goal of this study is to evaluate for surgical EMI in subjects with leadless pacemakers.

Subjects with Micra leadless pacemakers requiring surgery will have procedure records reviewed for type of procedure and use of electrosurgery. Next postoperative device interrogation will be reviewed for evidence of EMI. EMI will be evaluated by review of sensing integrity counter, heart rate histograms and device reset.

Eligibility Criteria:
Inclusion criteria:

* subjects with an implanted Micra pacemaker who required a surgical procedure

Exclusion Criteria:

* no Micra pacemaker
A Preliminary Study About Unexplained Recurrent Miscarriage and Repeated Implantation Failure Patients Treated With Low-dose Lymphocyte Immunotherapy

Recurrent miscarriage(RM) and recurrent implantation failure (RIF) are clinical challenge for clinicians and patients who are desperate for a healthy child.The specific etiology contains chromosomal abnormalities, reproductive anatomical abnormalities, endocrine disorders, reproductive system infections, autoimmune and environmental factors. However there are still 50% to 60% RM and RIF which don't have a clear cause,mainly associated with alloimmune factors.Among various treatments,lymphocytes active immunotherapy is the most common treatment method, and its clinical efficacy is widely recognized although its action mechanism is not clear so far.

The main mechanism of active immunotherapy includes upregulating Th2-type cytokines, downregulating Th1-type cytokines, making Th1 / Th2 shift to Th2, inducing maternal serum IL-6 and sIL6R, PIBF, EGF; inducing the expression of Fas / Fasl on lymphocyte surface; increasing the proportion of CD8 + cells, Th2-type cells and CD + CD25 + Treg cells, decreasing the activity of CD56 + CD16 + NK cell and so on.The purpose of this study is to observe the treatment effects of active immunotherapy on uRM and RIF patients. What's more,we will used flow cytometry, and quantitative real-time PCR (qPCR) methods to characterize Th1、Th2 and Treg cell populations after immunotherapy,ecpecting to find out the exact molecule mechanism of immunotherapy with paternal or third party lymphocytes.

Eligibility Criteria:
Inclusion Criteria:

* Healthy except for their history of recurrent abortions and were negative for blocking antibodies
* Willing to receive follow up

Exclusion Criteria:

* Patients with genetic impairment
* Patients with Mullerian anomaly
* Patients with hormonal deficiency
* Patients with metabolic disorder
* Patients with infectious disease
* Patients with autoimmune abnormalities
Liver Stiffness Measurement in Alcohol-dependent Subjects in Relation to Abstinence After Withdrawal

This study is complementary to the main study "Brain Derived Neurotrophic Factor Serum Levels Evolution During the Six Months After Alcohol Withdrawal " NCT01491347.

Liver stiffness variation is one of the major somatic effect of chronic alcohol consumption. It is a consequence of numerous mechanisms, including inflammation. Liver stiffness seems to depend on alcohol consumption in alcohol dependent patient, more precisely on the time after the last alcohol consumption. This is very few documented after alcohol withdrawal, and has never been explored during several months after withdrawal as a function of alcohol consumption and abstinence.

Brain Derived neurotrophic Factor (BDNF) seems to play a major role in general homeostasis and also liver function.

We propose here to analyse the serum BDNF levels variations after withdrawal according to liver stiffness levels and alcohol consumption status.

We will also measure liver stiffness using Fibroscan® in alcohol dependent subjects included in the main study to search for a link with serum BDNF levels and abstinence at day 0, 14, 28 and months 2, 4, and 6.


Eligibility Criteria:
Inclusion Criteria:

* participation to the study "BDNF serum levels evolution during 6 months after alcohol withdrawal" (main study)
* criteria from the main study

Exclusion Criteria:

* criteria from the main study