cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Safety, PK/PD of (OriCAR-017) in Subjects With RR/MM - RIGEL Study

The is a first clinical study for Oricell Therapeutics Inc. in the United States to evaluate the safety, PK, PD and preliminary efficacy of our anti-GPRC5D cell product (OriCAR-017) in subjects with relapsed/refractory multiple myeloma.

RIGEL Study

This is a Phase I/II, open-label multicenter study to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of anti-GPRC5D CAR-T cell product (OriCAR-017) in subjects with relapsed/refractory multiple myeloma". The study will consist of a Phase I dose escalation stage involving three doses as a single IV infusion) with up to 18 evaluable subjects and a dose expansion stage with 10-15 evaluable subjects, followed by a Phase II stage with up to 48 evaluable subjects.

Eligibility Criteria:
Inclusion Criteria:

Capable of giving signed informed consent

Subjects aged 18 to 75 years (inclusive) at Screening (signing the ICF).

Expected survival period is \>12 weeks.

Diagnosis of MM according to the IMWG criteria (2016 version).

One of the following criteria must be met:

If immunoglobulin (Ig)G type MM, then serum M protein \>10 g/L; if IgA, IgD, IgE or IgM type MM, then serum M protein \>5 g/L

Urine M protein level \>200 mg/24 hour

If light chain type MM, then serum free light chain (sFLC) \>100 mg/L and K/λ FLC ratio is abnormal.

Extramedullary lesions (\>1 cm for diameter of the short axis).

For Phase I (dose-escalation) - Subjects who had received at least 3 prior lines of therapy, had previous exposure to BCMA-Ag+ therapies, and were refractory to the last line of therapy.

For Phase I (dose-expansion) and Phase II: Subjects with previous exposure to BCMA directed therapies including BCMA bispecific antibody (e.g., teclistamab), BCMA antibody directed conjugate (such as BLENREP), and BCMA-CAR-T (such as CARVYKT1TM)

Subjects with adequate hematologic, renal, hepatic, pulmonary and cardiac function.

Subject and partners willing to take and or use effective contraceptive measures until 2 years post IMP infusion.

Exclusion Criteria:

Pregnant or breastfeeding.

Seropositive for history of human immunodeficiency virus Active Hepatitis B infection and or Hepatitis C infection

Known active or prior history of CNS involvement

History of autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) caused damage to terminal organs or required systemic application of immunosuppressive or other drugs in the past 2 years

Presence of uncontrolled active infection

Subjects who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks of Screening Visit or who plan to undergo ASCT during the study.

Subjects who received allogeneic stem cell therapy.

Any condition that in the opinion of the Investigator, would interfere with evaluation of the IMP.

Received Bendamustine treatment 1 year prior to Screening Visit.
Hospitalized Smokers

Post-discharge support is a key component of effective treatment for hospitalized smokers, but very few hospitals provide it. Linking hospitalized smokers with free, proactive tobacco quitlines is an ideal way to provide supportive contact at discharge, because quitlines are effective and cost effective for smoking cessation. Many hospitals are beginning to fax-refer smokers to quitlines at discharge. Fax referral is convenient and is part of the current culture of medical communication channels. However, less than half of fax-referred smokers are successfully contacted and enrolled in quitline services. "Warm hand-off" is a novel approach to care transitions in which health care providers directly link patients that have substance abuse and mental health problems with specialists, using face-to-face or phone transfer. Warm hand-off achieves very high rates of treatment enrollment for these highly vulnerable groups.

The objective if this application is to determine the relative effectiveness, and cost-effectiveness, of warm hand-off versus fax referral for linking hospitalized smokers with tobacco quitlines. This study employs a two-arm, individually randomized design. It is set in two large Kansas hospitals that have dedicated tobacco treatment interventionists on staff.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria include being residents of Kansas,
* aged 18 years and older,
* have smoked at least 1 cigarette in the 30 days prior to admission,
* speak Spanish or English,
* and wish to remain abstinent after they are discharged
* Patients who are discharged to another facility (for long term care or rehabilitation) will be included in the trial.

Exclusion Criteria:

* Exclusion criteria include lacking access to a telephone post-discharge,
* acute life-threatening medical conditions (for example, cardiac arrest, acute respiratory failure, septic shock),
* communication barriers (intubation, unable to speak or hear),
* altered mental status,
* severe unstable psychiatric disorder (acute psychosis),
* terminal illness with less than a 12 month life expectancy
* non-Kansans because residents of other states may receive quitline services from a different vendor which would confound intervention effects and make it difficult to obtain quitline adherence data
SH Dr. Chen Gastric Bypass Study

Evaluation of serum gastrin levels and their effect on marginal ulcer formation.

Prospective, randomized, interventional trial. Participants will be randomized to one of two surgical techniques, either with transection of the vagal nerves, or without. Outcomes including compare marginal ulcer rates will be compared using serum gastrin levels before and after surgery and gastric pH during surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Diagnosis of obesity or disorder of metabolism undergoing routine gastric bypass surgical intervention
* Capable of giving signed informed consent.

Exclusion Criteria:

* Under 18 years of age
* Ineligible for gastric bypass surgery
* Pregnant women or women actively seeking to become pregnant.
Assessment of Prototype Hand-Held Fundus Camera

Assessment of handheld fundus images in comparison to conventional fundus camera images.

This study is comparing a small handheld camera with a standard fundus camera for image quality

Eligibility Criteria:
Inclusion criteria:

* Age \> 18
* The ability to give informed consent and be willing to spend up to two hours in the eye clinic during the duration of the study.
* The subjects may have a normal retina and optic nerve, or subjects may have abnormalities of the posterior pole of the retina or the optic nerve.

Exclusion criteria:

* Medical or ophthalmic instability that would create a contraindication for minimally invasive ophthalmic diagnostic testing will exclude participation as a subject.
* Ophthalmic pathology felt by the principal investigator that would make retinal imaging with standard photographs difficult or not possible.
Oral HYCAMTIN Plus Whole Brain Radiation Therapy In Treatment Of Brain Metastases Resulting From Non-Small Lung Cancer

The current prognosis for patients with metastatic brain cancer from NSCLC is very poor. The current standard treatment for this disease is radiation therapy to the brain. The goal of the current study is to test whether the combination of orally administered HYCAMTIN capsules and whole brain radiation therapy will prolong the survival time of patients with this potentially serious condition.


Eligibility Criteria:
Inclusion criteria:

* At least one measurable cancerous lesion in the brain from primary non-small cell lung cancer (NSCLC)
* Must have received previous chemotherapy
* Must be 18 years of age of greater
* Must be Easter Cooperative Oncology Group (ECOG) Performance Status 0, 1, 2
* At least 2 weeks must have elapsed since any surgery
* At least 4 weeks must have elapsed since any radiation to a non-CNS site
* Must have adequate bone marrow, renal, and live capacities
* Women must be of non-childbearing potential or practice adequate birth control
* Males must practice adequate methods of birth control
* Must sign written informed consent

Exclusion criteria:

* Previous whole brain radiation therapy
* Prior treatment with topotecan
* Investigational agent within 30 days or 5 half-live
* Concomitant therapy with inhibitors of breast cancer resistance protein (BCRP) or P-glycoprotein such as erlotinib or gefitinib
* Primary or secondary immunodeficiencies
* Gastrointestinal conditions that affect GI absorption or motility
* Uncontrolled emesis
* Brain metastasis at time of initial diagnosis of NSCLC
* History of other malignancy except in situ carcinoma of cervix; nonmelanomatous skin cancer, low grade prostate cancer
* Pregnant or intending to become pregnant or intending to father a baby
* Any severe concurrent medical condition that could affect compliance.
Pulse Shortwave Therapy in Cervical Osteoarthritis

The ActiPatch is an FDA cleared pain therapy device that uses pulsed shortwaves to interrupt pain signals at the nerve. 200 patients will be randomized and divided into an ActiPatch treatment group and comparison analgesic drug therapy group . Subjects will be assessed with the Neck Disability Index (NDI) at baseline and at four weeks and VAS scores will be recorded in order to determine the efficacy of the ActiPatch device compared to Etoricoxib. Cervical osteoarthritis causes chronic neck pain which could potentially be alleviated by the ActiPatch without the use of medication.

Cervical Osteoarthritis causes chronic pain in the neck due to the discs of the spine breaking down, losing fluid, and becoming stiffer over time. As obesity and age increase, the likelihood of cervical osteoarthritis increases as well. When the pain caused by the broken down discs becomes severe, it may result in a loss of mobility in the neck region. Chronic neck pain has a serious impact on not only quality of life, but can also negatively affect a persons ability to lead a healthy active lifestyle. Standard analgesic therapy it limited in efficacy and can result in serious adverse effects specially with long term use.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Neck Pain of \> 2 months
* Cervical Osteoarthritis - Radiological Evidence
* Males \& females
* Age: 30-60 years

Exclusion Criteria:

* Neck Pain \<2 months
* Pregnancy
* Irreversible neck injury
* Congenital Neurological/Muscular Diseases
* Osteo-articular Disorders
* Auto-immune Diseases
* Osteoporosis
* Hematological Diseases (Thalassemia/Sickle Cell Anemia)
* Cancer
* Contra-indication to Etoricoxib 60 mg
* Age \<30 or \>60 years
Feasibility Study of CVC Diagnosis Via Ultrasound in Children

After the placement of a central venous catheter in children, a routine chest X-ray will be performed in order to examine the correct position of the catheter. In this feasibility study the investigators intend to evaluate whether the ultrasound is as sufficient as the chest X-ray to verify the correct position of the central venous catheter in children with the purpose to prevent radiation on children in the future.

For punctures of a central vein in very small children, ultrasound is an useful tool which allows for exact examination of the relevant anatomy in order to visualize the target vessel, so as to facilitate the puncture in real-time. However, to ascertain the correct position of the central venous catheter (CVC), a chest X-ray is still the gold standard. The main disadvantage of the X-ray is the children's exposure to radiation. That's why the investigators intend to perform this study whether the ultrasound is as sufficient as the chest X-ray to verify the correct position of a central venous catheter in children.

Eligibility Criteria:
Inclusion Criteria:

* Infants and children aged between 0 and 8 years requiring a central venous catheter. The planned sample size is 20 subjects. The indication for a CVC, will be determined by the attending physician.

Inclusion criteria:

* Infants (inclusive early and late preterm) and children aged between 0 and 8 years
* Necessity of a central venous catheter
* Written informed consent given by parents after being provided with detailed information about the nature, risks, and scope of the catheterization
* No legal incapacity and/or other circumstances rendering the parents unable to understand the nature, scope and possible consequences of the catheterization

Exclusion Criteria:

* Parents refusal
Alcohol Impaired Driving: From the Laboratory to the Natural Environment

This project combined laboratory and ambulatory assessment (AA) methods to test decision making associated with alcohol impaired driving (AID). Participants will complete a laboratory alcohol administration session followed by 6 weeks of mobile assessment. Data from drinking events will be examined to test how individuals make choices about driving or not after consuming alcohol.

Building on laboratory findings from the the PI's (McCarthy) previous work, this project is designed to test AID decision making in both the lab and the natural drinking environment in which AID decisions are made.

Participants complete a laboratory alcohol administration session followed by six weeks of multi-method ambulatory assessment. The ambulatory assessment component will include participant report via smartphone, portable breathalizer (BACtrack), and location and movement data passively collected by the smartphone GPS/accelerometer. The combination of these methods will allow for the integration of subjective (e.g., perceived intoxication) and objective (e.g., BrAC, calculated drinking location) data for each drinking episode.

Aim 1 of the project is to test laboratory measures as prospective predictors of AID and examine the role of event-level influences on specific AID decisions.

Aim 2 of the proposed project is to test the potential for a novel intervention to reduce AID using mobile technology. Participants will be randomly assigned to either a full ambulatory assessment or a minimal assessment control condition. The timing of the introduction of AA will also be manipulated within the full ambulatory assessment condition. This design will allow us to test whether the introduction of ambulatory assessment produces changes in AID behavior, as well as whether such changes persist once ambulatory assessment is discontinued. Changes made to the revised application are aimed at ensuring the achievement of both study aims. If Aim 2 is achieved and ambulatory assessment alters AID behavior, the combination of the minimal assessment control condition and the full assessment condition prior to the introduction of ambulatory assessment has sufficient sample size and power to test Aim 1 hypotheses.

Eligibility Criteria:
Inclusion Criteria:

* moderate to heavy drinkers must drive regularly report recent binge drinking fluent in english

Exclusion Criteria:

* not in treatment for substance use disorder or other psychiatric disorders BMI under 30 no medical conditions contraindicating alcohol consumption
Assessment of Safety and Effectiveness of Biodegradable Temporizing Matrix in the Treatment of Deep Burn Skin Injuries

This is a multi-center, single arm, traditional feasibility study to allow a preliminary assessment of the safety and effectiveness of a new method of treating skin burns using Biodegradable Temporizing Matrix (BTM).

This is a multi-center, single arm, traditional feasibility study to allow a preliminary assessment of the safety and effectiveness of BTM treatment. Patients with 10-70% TBSA burns will have BTM devices implanted in areas with deep partial or full thickness burns to treat at least 5% TBSA.

Eligibility Criteria:
Inclusion Criteria:

* Provides written informed consent (directly or via legal representative) prior to any clinical trial procedures being performed.
* Willing to comply with all study procedures and expects to be available for the duration of the study.
* Male and non-pregnant females ≥ 18 years of age and ≤ 70 years of age.
* Patients with deep partial or full thickness burns (between 10% and 70% inclusive of their TBSA).

Exclusion Criteria:

* Has a known hypersensitivity to polyurethane or silver-containing materials.
* Multiple traumas (significant traumatic injury to a solid organ in addition to skin).
* Presence of a medical condition with a life expectancy of less than 12 months, such as advanced malignancy.
* Presence of a medical condition that might interfere with treatment evaluation; or require a change in therapy including but not limited to, significant immune deficiency, or skin or vascular diseases in the area of the wound.
* Female with known or suspected pregnancy, planned pregnancy, or lactation.
* Has had exposure to any other investigational agent within the last 6 months.
* Has a clinically significant psychiatric illness.
* Has a condition the Investigator believes would interfere with the ability to comply with study instructions, or that might confound the interpretation of the study results or put the subject at undue risk.
Validation of DaTscan for Detection of Parkinson Disease Related Disorders

This investigator initiated trial is designed to measure the accuracy of diagnosis of Parkinson disease through the use of DaTscan. Currently, DaTscan is FDA approved to measure dopamine transporter densities in human tissue. This measurement can assist in distinguishing between Essential Tremor and Parkinsonian Syndromes (idiopathic Parkinson disease, Progressive Supranuclear Palsy, Multi Systems Atrophy, etc). This study will compare both clinical diagnosis of symptoms and the results of the scan to the pathological diagnosis received at time of death. Patients will be registered in the Parkinson Research Institute's brain donation program, receive a clinical diagnosis of Parkinson disease, have their brain scanned using DaTscan, and donate their tissue for research and autopsy purposes. The hypothesis of the study is that DaTscan will diagnosis Idiopathic Parkinson Disease as accurately as a clinician.


Eligibility Criteria:
Inclusion Criteria:

* aged 75 or older
* sporadic late onset Parkinson disease or one of its variants
* registered in tissue donation program

Exclusion Criteria:

* aged less than 75 years old
* mental status preventing neuroimaging or transportation to site
* inability to remain "relatively steady" during the scanning procedure
Assessment of Gesture Accuracy of a Prosthesis Control System

The study is evaluating the performance of prosthesis control system, referred to as Phantom X, in able bodied individuals and individuals with upper limb amputation at the forearm level.

The study will characterize the performance of Phantom X system and associated algorithms in decoding EMG signals for various hand gesture control. The EMG signals will be sensed using a non-invasive multi-electrode array applied to subjects' forearms.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals 21 years in age and older
2. Individuals with amputation of one or both arms at transradial level (applies to amputees only)
3. Ability to follow study directions
4. Willingness and ability to sign Informed Consent

Exclusion Criteria:

1. Individuals with previously diagnosed muscle pathologies
2. Individuals with impaired muscle function and/or impaired ability to perform normal hand movements (normal participants) or ability to perform normal phantom hand movements (amputees)
3. Individuals with transhumeral or higher amputation of both arms (applies to amputees only)
4. Cognitively impaired to follow study instructions
5. Allergies to skin adhesive materials necessary for cutaneous electrode placement
6. Excessive hair growth on arms and inability to shave off the hair for electrode placement
7. Pregnant woman
8. Arms or residual limbs with insufficient diameter to accommodate the wearing of two cutaneous sensor arrays
9. Injuries, bruises, or open wounds on the arm that needs to be instrumented for the study
Physical Activity and Food Intake Interaction: Effect of Weight Loss in Obese Adolescent

In obese adolescents, energy expenditure (EE) of chronic high intensity muscular exercise (\> 70% VO2max) conducted one hour before a meal causes an anorectic effect at lunch and dinner the same day. The effect on food intake of the distribution of this exercise into two sessions during 24h remains to be determined. In addition, a multidisciplinary load of obesity generates a loss of body weight in the short term, which we do not know the effects on energy balance. To our knowledge, the impact of weight loss on the anorectic effect of muscle exercise is unknown.

Two measuring sequences will be carried out before (M0) and after 4 months (M4) of a multidisciplinary treatment program of four months. Each sequence will have three days: a "sedentary" day (SED) and two days "exercise" (EX). During the exercise day "EX1", a continuous intense exercise will be conducted for 40 min at 70% VO2max of subjects. During the second day exercise "EX2" teenage realize two exercise representing the same DE as EX1 in the morning (50% ED) and late afternoon (50% ED). The multidisciplinary management program (without energy restriction) controlled by institution consists of nutrition education, physical activity and therapeutic education. The exercise program will involve the activity sessions controlled and supervised by a sports educator and interactive sessions using a scientifically validated physical activity program (Biomouv®).

Eligibility Criteria:
Inclusion Criteria:

* Overweight adolescents (over the 90 th percentile of the international cut-off point)
* Sedentary (according to the IPAQ-A questionnaire)
* Without eating disorders (according to the DEBQ questionnaire)

Exclusion Criteria:

* Medical or surgical antecedents that are incompatible with the study: cardiovascular, endocrine or digestive disease.
* Drugs that could interfere with the results of the study
* Surgical intervention in the 3 months
* Regular consumption of tobacco or Alcohol
* patients on a diet with caloric restriction
* Refusal to sign the consent form
* Regular practice of sport and intensive
Coronary Computed Tomography Versus Invasive Angiography for Non-ST Elevation Acute Coronary Syndrome

Coronary computed tomography angiography (CCTA) is a widely accepted initial diagnostic test for individuals suspected of having chronic coronary syndromes. However, there is limited evidence supporting its use in the acute setting. So far, no large-scale randomized trial has examined the performance of CCTA as an alternative to invasive coronary angiography (ICA) in individuals with non-ST-segment elevation myocardial infarction (NSTEACS).

If CCTA were to replace ICA as a routine procedure for individuals with NSTEACS, it could reduce the risk of complications related to ICA, improve patient comfort, expedite decision-making, and reduce healthcare expenses and interhospital transfers.


Eligibility Criteria:
Inclusion criteria:

* Admitted with non-ST-segment elevation myocardial infarction or unstable angina pectoris and an indication for subacute ICA
* Elevated troponin or ischemic electrocardiographic changes
* Written informed consent

Exclusion criteria:

* Instability requiring acute or emergent ICA
* History of percutaneous coronary intervention or coronary artery bypass grafting
* Estimated glomerular filtration rate \&lt; 30 mL/min/1.73m2
* Probable type 2 acute myocardial infarction
* Severe valvular heart disease as primary diagnosis or potential need for valve intervention
* History of spontaneous coronary artery dissection
* Expected poor quality of the CCTA
* Prior CCTA or ICA during index admission or within 1 week
* Known allergy to beta-blockers or contrast agent
* Pregnant or nursing
* Previously randomized in this trial