cyrilzakka/clinical-trials huggingface dataset:
Study to Assess Safety, Efficacy, and Cellular Kinetics of YTB323 in Generalized Myasthenia Gravis

This is a phase I/II study to assess safety, efficacy, and cellular kinetics of YTB323 in participants with treatment-resistant generalized myasthenia gravis. YTB323 is a Biological CAR-T cell therapy.

This is an open-label, multi-center, non-confirmatory study intended to assess safety, efficacy, and cellular kinetics of YTB323 treatment in participants with treatment-resistant generalized myasthenia gravis in order to enable a benefit to risk assessment for further development in generalized myasthenia gravis (gMS). The study plans to enroll approximately 15 participants with treatment-resistant gMG. The study utilizes a single dose design across 2 cohorts, consisting of a sentinel cohort of 3 patients followed by an expansion cohort of an additional 12 patients.

All participants dosed with YTB323 will be followed until 15 years after YTB323 administration in the Long-Term Follow-up (LTFU).

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed gMG diagnosis supported by the following:

   * Documented report of positive serology testing for either AChR antibodies or MuSK antibodies at screening AND at least one of the following:
   * History of abnormal neuromuscular transmission test demonstrated by repetitive nerve stimulation or single-fiber electromyography
   * History of positive acetylcholinesterase inhibitor test
   * Improvement in MG signs on an oral acetylcholinesterase inhibitor as assessed by the treating physician
2. MGFA Class III-IVa (gMG) at screening
3. Treatment-resistant gMG as defined by: MG-ADL score ≥ 6 at screening despite adequate treatment trials with at least two different non-steroidal immunosuppressive drugs given at adequate doses and duration of therapy.
4. If on chronic corticosteroids, the ability and willingness to taper to a maximum dose of 10 mg prednisolone daily or equivalent at least one week before leukapheresis
5. If treated with cholinesterase inhibitors, patients must be on a stable dose for at least two weeks prior to screening

Exclusion Criteria:

1. Exclusively ocular myasthenia gravis (MGFA I), mild symptoms (MGFA II), or severe bulbar disease or MG crisis, MGFA Class IVb or V at screening
2. History of bone marrow/hematopoietic stem cell or solid organ transplantation.
3. Clinically significant active, opportunistic, chronic or recurrent infection (including positive for hepatitis B or hepatitis C) confirmed by clinical evidence, imaging, or positive laboratory tests one month prior to leukapheresis
4. Other uncontrolled disease states, such as asthma, or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids, at screening
5. Participants with a known immunodeficiency syndrome (AIDS, hereditary immune deficiency, drug induced immune deficiency), or tested positive for HIV antibody, at screening
6. Prior treatment with anti-CD19 therapy, adoptive T cell therapy or any prior gene therapy product (e.g. CAR-T cell therapy).

Other protocol-defined inclusion/exclusion criteria may apply
Effects of the Fully Immersive Leisure-based Virtual Reality Cognitive Training for Community-dwelling Elderly

This study aims to (1) determine the feasibility and usability of immersive leisure-based VR cognitive training; (2) identify the intervention effects of immersive leisure-based VR cognitive training on cognitive function, daily function, and quality of life for elderly with community-dwelling elderly

Cognitive training integrated into leisure activities can increase the training motivation of the elderly, while improving cognitive performance and daily functions. Virtual reality (VR) can simulate daily living situations, and it can be an effective intervention with cognitive training. Although a few studies have found immersive VR cognitive training can improve the cognitive function of the elderly with cognitive decline, these studies have shown inconsistent results. In addition, it is yet not clear the long-term effect of fully immersive VR cognitive training and its impact on daily function. Furthermore, for immersive VR cognitive training, there is still a lack of training programs that integrate into the context of leisure activities. This type of VR cognitive training could help the effectiveness of cognitive training to be transferred into daily functions.

Eligibility Criteria:
Inclusion Criteria:

1. age\>=60
2. able to follow instruction
3. MMSE\>=21

Exclusion Criteria:

1. dizziness or epilepsy history;
2. neurological or other orthopedic diseases with neurological or other orthopedic diseases (3)unstable physical condition of VR cognitive training;

(4)Recent psychiatric diagnosis, such as depression
Impact of Reading on Endogenous Oxytocin System of Preterm Infants

The purpose of this study is to learn how early language exposure may be related to changes in DNA in parents and their premature infants. While a person's genetic code is determined at the time of conception, the way that some genes are expressed in the body can be changed even after an individual is born. These changes are called epigenetic changes. In this study, the investigators want to learn about the epigenetic changes that happen after a premature baby is born and whether a parent's interaction with their baby can influence these epigenetic changes. The investigators will look at epigenetic changes by collecting saliva samples from parents and their preterm babies, here defined as babies born at \<33 weeks gestation. Specifically, the investigators will be looking at salivary levels of DNA methylation of the oxytocin receptor gene (OXTRm). The investigators will track changes in OXTRm levels over time in parents and their babies and see if these levels change in relation to how much time parents spend with their babies and how much time they spend reading to their babies. The investigators will ask mothers and, if desired, their partners to read to their babies for at least 15 minutes per week. The investigators will ask them to track time spent with the baby and reading time on a log, and will also measure word count with a commercially-available LENA device. The investigators will use logistic regression analysis to identify the independent association between OXTR DNA methylation and time spent with parent(s) and word count.

Student's t-test and Pearson's chi-square tests will be used to compare continuous and categorical variables, respectively. Logistic regression analysis will used to identify the independent association between OXTR DNA methylation and time spent with parent(s) and word count. Variables with p≤0.20 in the univariate analysis will be entered into a stepwise logistic multivariate regression model. Odds ratios with 95% confidence intervals will be calculated. p value of less than 0.05 will be considered statistically significant.

A protocol modification was submitted to and approved by the University of Virginia IRB due to slower than expected participant enrollment. The protocol was modified such that:

* Enrollment of \<33 week instead of \<32 week infants was permitted
* Enrollment was permitted through the first 2 weeks after birth instead of through the first 1 week after birth

Eligibility Criteria:
Inclusion Criteria:

* Infants \<33 week gestational age at birth
* Mother must be able to visit at least once per week
* Mother or primary caregiver must participate; father or secondary caregiver may participate as well
* Mother must commit to minimum of 15 minutes reading at least once per week

Exclusion Criteria:

* Infant with life-limiting conditions
* Mother is non-English speaking
* Illiteracy of mother
Study of GLUCUBE Performance, a Non-invasive System for Monitoring Blood Glucose Levels Based on Near Infrared Spectroscopy (NIRS) Technology.

This study is a prospective, single center, non-interventional, open label clinical investigation. The primary objective of the study is to evaluate the performance of GLUCUBE system compared to the standard glucometer in the determination of blood glucose level in adult patients.

The current methods for blood glucose measurements, glucometers, although minimally invasive, can be painful, requiring puncturing the fingertip with a lancet device and removing a drop of blood, that applies to a disposable test strip. This minimal invasiveness may cause discomfort and deter the user from measuring his/her blood glucose levels as frequently as required. Due to GLUCUBE device non-invasive nature, it is expected to give the patient or health care provider immediate reliable quantitative as well as qualitative information, safely and painlessly avoiding any type of discomfort to the user.

This study is a prospective, single center, non-interventional, open label clinical investigation designed with a total amount of 105 subjects. Study participants will take the GLUCUBE device and standard glucometer home and each subject will take 4 pairs of measurements per day for a week.

Eligibility Criteria:
Inclusion Criteria:

1. Be ≥ 18 years old.
2. Have a smartphone with an internet connection that allows the installation of GLUCUBE APP
3. Have signed the informed consent.

Exclusion Criteria:

1. Subject is currently participating in another clinical investigation or has participated in another clinical investigation in the past 30 days prior to the start of the present study.
2. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
3. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
4. Patients with any acute active and/or infectious disease.
5. Patients who have a condition that affects blood circulation in the fingers of the hand, such as Raynaud's phenomenon.
6. Any medical condition that, by the investigator judgment, will increase the risk from hyper and hypoglycemic event: seizures, heart disease, hypoglycemia unawareness, etc.
7. Patients who, in the opinion of the investigator, do not have sufficient manual dexterity to perform the tests themselves.
8. Patients with an inability to maintain stability of the hand during measurement or with progressive disease of the nervous system that affects movement (Parkinson's disease, moderate-severe essential tremor, and other diseases with involuntary movements).
9. Patients suffering from calluses, malformations, or open wounds with bandages.
10. Patients with nail polish or any type of false nail.
11. Subjects who do not understand or cannot follow the Procedures Involved in the Use of the Device Under Investigation.
Point-Of-Care Chemistry Test (POCT) Effect on the Emergency Department (ED)

The hypothesis of this study is that POCT will shorten ED turn-around-time (TAT) such as blood drawing TAT, lab TAT, and decision TAT.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 15 years
* clinically required to have chemistry lab tests
* agreement

Exclusion Criteria:

* no agreement
* ESI level 1
Clinical Evaluation of T.R.U.E. Test Allergens in Children an Adolescents

The objective of the study was to evaluate the diagnostic performance and safety of T.R.U.E. Test allergens in pediatric subjects aged 6-17 years old. In total, 11 allergens were evaluated; 7 new allergens on panels 2.2 and 3.2 and 4 previously approved allergens for which changes were made to dose and excipient.

The evaluation of 7 new allergens on panels 2.2 and 3.2, Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Bacitracin, Parthenolide, Methyldibromoglutaronitrile, Disperse blue 106, and Bronopol was the original objective of the study. The protocol was amended to include evaluation of 4 reformulated allergens; neomycin sulfate, potassium dichromate, ethylenediamne dihydrochloride and fragrance mix.

Eligibility Criteria:
Inclusion Criteria:

* Symptoms and history potentially consistent with allergic contact dermatitis
* Children and adolescents 6-17 years of age, in general good health
* Adolescent females 15 years of age or older (or with menarche) must consent to a urine pregnancy test; urine test results must be negative for study inclusion
* Informed consent must be signed and understood by subject. If underage, informed consent must be signed and understood by parent or legal guardian, consistent with all institutional, local and national regulations

Exclusion Criteria:

* Topical corticosteroid treatment during the last 7 days on or near the test area.
* Systemic treatment with corticosteroids or other immunosuppressives during the last 7 days.
* Subjects currently receiving (or received during the previous 3 weeks) other investigational drugs, treatments or devices, or participating in another clinical study
* Treatment with ultraviolet (UV) light (including tanning) during the previous 3 weeks
* Acute dermatitis outbreak or dermatitis on or near the test area on the back
* Subjects unable to comply with activity restrictions (e.g. protecting test panels from excess moisture due to showering or vigorous activity)
* Subjects unable or unwilling to comply with multiple return visits
* Female subjects 15 years of age (or with onset of menarche) and older unable to consent to a urine pregnancy test, or those with a positive pregnancy test
Study of Venous Thromboembolism Risk Profiles and Prophylaxis in Neurosurgical Inpatients

Venous thromboembolism (VTE), comprising deep venous thrombosis (DVT), pulmonary embolism (PE), or both, is a life-threatening complication in postoperative patients. VTE has been estimated an incidence ranged from 79 per 100000 to 269 per 100000 population1. The incidence of VTE rises up to 3.0% in average among all postoperative neurosurgical patients in recent studies, but the number varies in a large range according to primary diseases. This cross-sectional study was aimed to investigate the incidence, associated risk factors, prophylaxis, treatment, and outcomes of VTE in a large clinical neurosurgery center in China.

Venous thromboembolism (VTE), comprising deep venous thrombosis (DVT), pulmonary embolism (PE), or both, is a life-threatening complication in postoperative patients. This cross-sectional study was aimed to investigate the incidence, associated risk factors, prophylaxis, treatment, and outcomes of VTE in a large clinical neurosurgery center in China. 9010 patients underwent neurosurgery procedure were included. Distribution of age, sex, whether received PICC during perioperative period, and some special primary diseases are significantly different between VTE and non-VTE patients. Student's test and chi-square test were performed for analyses. We investigated VTE incidence, risk factors, prophylaxes, treatment and outcomes in postoperative neurosurgical patients, and summarized the VTE susceptible population of the patients, providing a VTE patient profile for neurosurgeons to concern.

Eligibility Criteria:
Inclusion Criteria:

Neurosurgical Inpatients. Underwent neurosurgery procedure.

Exclusion Criteria:

Acute or chronic respiratory failure. Acute myocardial infarction or other serious heart diseases.
Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis (REGAIN Study)

The purpose of this study is to determine if eculizumab is safe and effective for the treatment of refractory generalized Myasthenia Gravis.


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female patients ≥18 years old
* Diagnosis of MG made by the following tests:

  1. Positive serologic test for anti-AChR Abs as confirmed at screening, and
  2. One of the following:

     1. History of abnormal neuromuscular transmission test demonstrated by single-fiber electromyography (SFEMG) or repetitive nerve stimulation, or
     2. History of positive anticholinesterase test, e.g. edrophonium chloride test, or
     3. Subject has demonstrated improvement in MG signs on oral cholinesterase inhibitors, as assessed by the treating physician.
* MGFA Clinical Classification Class II to IV at screening.
* MG-ADL total score must be ≥6 at screening and Randomization (Day 1).
* Subjects who have:

  1. Failed treatment with at least two immunosuppressive agents. Or,
  2. Failed treatment with at least one immunosuppressive agent and require chronic plasma exchange or IVIg

Key Exclusion Criteria:

* History of thymoma or other neoplasms of the thymus
* History of thymectomy within 12 months prior to screening
* MGFA Class I or MG crisis at screening (MGFA Class V)
* Use of rituximab within 6 months prior to screening
* Use of IVIg or PE within 4 weeks prior to Randomization (Day 1)
Comparing the Effects of Positional Release Technique Versus Myofascial Release Technique of Gluteus Medius

Patellofemoral pain syndrome is a condition of misleading diagnosis. It mostly affects individuals with ages between 18-40 years. It is believed that much work has been done on the joint itself in treating the Quadriceps muscles and triggers related to it but now literature is focusing on the segmental involvement, where weakness of the hip abductors and lateral rotators play a major role. Therefore, interventions used for treating this syndrome should include on focusing the hip muscles for trigger point therapy as well as strengthening them in increasing the stability of the hip and pelvis to reduce excessive valgus forces on the knee.

Literature regarding Gluteus Medius trigger point is quite scarce especially in alleviating the pain related to Patellofemoral Pain Syndrome. The management of Patellofemoral Pain Syndrome includes a segmental treatment, giving special focus to the lateral rotators and abductors of the hip especially Gluteus Medius muscle, rather than treating the Patellofemoral Joint itself. It will help in improving the pain of the subjects suffering from this syndrome effectively, and within a shorter duration of time. It will also provide the practicing physiotherapist with an insight for treating such patients with better outcomes. Myofascial Trigger Points of the Gluteus Medius are important contributing factors in the management of Patellofemoral Pain Syndrome which is identified in a single study as per author's knowledge. But the treatment used to release the trigger point of Gluteus Medius in managing this syndrome has not yet been explored. So, this study will compare two well-known treatments in comprehending which one of the two techniques have better effects on the population to be studied. Written consent will be taken from all the study participants. Simple randomization technique will be used through "Randomization Main" software and randomization sheet will be generated. 60 participants with patellofemoral pain syndrome having Gluteus Medius trigger point will be randomly allocated in two equal group.

Eligibility Criteria:
Inclusion Criteria:

* Anterior knee pain \>1month and \<3 month
* Pain in activities like ascending \& descending stairs, running or sports activity \& prolonged sitting
* Presence of Gluteus Medius trigger point in the affected limb
* Age group 18-40 years
* Both genders

Exclusion Criteria:

* Dislocation of Patella
* Damaged cartilage and ligament of Knee Joint
* Soft tissue injury related to Knee
* Any knee or hip surgery
* Lumbar spine dysfunction
* Sacroiliac joint dysfunction
* Pelvic malalignment
* Flat foot
* Chondromalacia patellae
* Young onset Osteoarthritis
Study of Immune Deficiency Patients Treated With Subcutaneous Immunoglobulin (IgPro20, Hizentra®) on Weekly and Biweekly Schedules

The purpose of the study is to assess the impact of immunoglobulin treatment by subcutaneous injections every 2 weeks (biweekly) on a cohort of patients with primary and secondary immune deficiencies. The full study will consist of safety, efficacy and Quality of Life (QoL) evaluations and a pharmacokinetic (PK) sub-study. The primary objectives of the study are to determine tolerability and safety of biweekly IgPro20 injection regimen and to compare PK outcomes on weekly and biweekly IgPro20 therapy.

Patients who have received and/or are currently receiving immunoglobulin G (IgG) in intravenous (IVIg), or subcutaneous (SCIg) infusions are eligible for inclusion if they meet inclusion/exclusion criteria.

The study consists of two parts. In Part 1 of the study enrolled subjects will receive IgPro20 weekly for either 12 weeks (for patients on SCIg infusion prior to the study) or 24 weeks (for patients on IVIg infusion prior to the study). Part 2 will consist of a biweekly treatment with IgPro20 for 52 weeks, for both groups.

Additionally, study subjects meeting inclusion criteria for the PK sub-study will undergo a PK sample collection for 1 week and 2 weeks in study Parts 1 and 2, respectively.


Eligibility Criteria:
Inclusion Criteria:

Full study:

* Female or male patients with primary or secondary immunodeficiency, aged from 5 to 64 years, receiving steady state immunoglobulin G replacement therapy.

Pharmacokinetic sub-study:

* Female or male patients with primary immunodeficiency, aged between 12 and 64 years of age, on steady-state IgPro20 replacement therapy and willing to undergo pharmacokinetic sample collection on weekly and biweekly IgPro20 dosing regimens.

Exclusion Criteria:

* Patients with protein losing conditions such as: lymphangiectasis, nephrosis, status post cardio-thoracic surgery requiring drainage tubes for more than 48 hours, protein-losing enteropathy.
* Concomitant treatment with plasma or other blood products (including any IgGs other than IgPro20 \[Hizentra\]) within 21 days before study entry and/or during the study.
* Any other condition or treatment that, in the opinion of the investigator, would interfere with obtaining valid results for that subject.
* Women of childbearing potential with a positive pregnancy test.
* Active infection at the time of screening.
Kogenate FS Regulatory Post-Marketing Surveillance

To obtain data on safety, efficacy, and tolerability of KOGENATE FS under real-life conditions in its registered indications.

The observation period for each patient is up to 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of hemophilia A
* Treated with KOGENATE FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE FS
* Signed the informed consent form to participate in this study.
* For pretreated patients with more than 100 exposure days an inhibitor assessment within three months prior to enrollment should be available
* For pretreated patients with less than 100 exposure days an inhibitor assessment at baseline should be available
* For patients with no available inhibitor status, it should be checked as per the recommendation of KFDA
* Patients are defined as included in the study if there is a documented prescription of KOGENATE FS by the physician.

Exclusion Criteria:

* Patients with hypersensitivity to any ingredient of KOGENATE FS or to the protein of mouse or hamster will be excluded.
MODULA Modul 7 VRR

This study will look at the correlation between ventricular rate regulation (VRR) and the percentage of biventricular pacing as well as subjective quality of life and level of physical ability in CRT patients with atrial fibrillation.

To investigate whether VRR can increase the amount of biventricular pacing in CRT patients with conducted atrial arrhythmias. Secondarily, an investigation will be carried out to determine whether this increase in biventricular pacing results in an improvement in quality of life, as well as an improvement in the symptoms caused by the atrial arrhythmia and an improvement in the level of physical ability.

Eligibility Criteria:
Inclusion Criteria:

* Patients with CRT system with the VRR algorithm
* Patients with permanent atrial fibrillation
* Occasional conducted atrial fibrillation resulting in ventricular rates \> 70 beats per minute (bpm)
* QRS complex \> 120 ms

Exclusion Criteria:

* Patients with third degree atrioventricular (AV) block