cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Anti-FcRL5 CAR-T Cell Therapy in Treating Relapsed and Refractory Multiple Myeloma (R/R MM)

This is an open label, single-arm, Phase 2 study to evaluate the efficacy and safety of Anti-FcRL5 CAR-T in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture. Anti-FcRL5 chimeric antigen receptor (CAR) modified T cells. Prior to Anti-FcRL5 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.

This open label, single-arm, Phase 2 study aims to evaluate the efficacy and safety of Anti-FcRL5 CAR-T in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture. Anti-FcRL5 chimeric antigen receptor (CAR) modified T cells. Prior to Anti-FcRL5 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide. After infusion, the investigators will observe the characteristics of dose limited toxicity (DLT), and determine the maximum tolerable agent MTD and rp2d were confirmed. To provide basis for the dosage and treatment plan of cell products in follow-up clinical trials.

Eligibility Criteria:
Inclusion Criteria:

The set subject inclusion criteria include multiple documents of multiple myeloma, no effective treatment options (e. g. autologous or allogeneic stem cell transplantation) and limited outcome (\<2 years) with existing therapies, as follows:

1. Age is 18\~70 years old;
2. Expected survival period of\>12 weeks;
3. Multiple myeloma was diagnosed by physical examination, pathological examination, laboratory examination and imaging;
4. Patients with refractory multiple myeloma;
5. Patients with multiple myeloma recurrence;
6. ALT and AST \<3 times normal; bilirubin \<2.0mg / dl;
7. Quality of survival score (KPS)\> 50%;
8. The patient has no serious heart, liver, kidney and other diseases;
9. Recurrence or no disease remission after hematopoietic stem cell transplantation or cellular immunotherapy;
10. Is not suitable for stem cell transplantation conditions or to abandon transplantation due to conditional restrictions;
11. Blood can be obtained intravenously, without other contraindications to leukapheresis;
12. Understand and voluntarily sign a written informed consent form.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding, or who have a pregnancy plan within six months;
2. Infectious diseases (such as HIV, active tuberculosis, etc.);
3. Active hepatitis B or hepatitis C infection;
4. Feasibility assessment screening demonstrated \<10% transfection of targeted lymphocytes or underamplification under CD3 / CD28 costimulation (\<5-fold);
5. Abnormal vital signs, and unable to cooperate with the examination;
6. Have mental or mental illness who cannot cooperate with the treatment and efficacy evaluation;
7. Highly allergic constitution or have a history of severe allergies, especially allergic to IL-2;
8. Subjects with a systemic infection or a severe local infection requiring anti-infective treatment;
9. Subjects with severe autoimmune disease;
10. The doctor believes there were other reasons for inclusion
Resistance to Antithrombotic Therapy

Clopidogrel plays a pivotal role in the antithrombotic regimen after percutaneous intervention with stent implantation. However, response to clopidogrel shows a wide interindividual variability and a high on-treatment residual ADP-inducible platelet reactivity has already been associated with an increased risk for adverse events after coronary stenting. In the present study, platelet reactivity will be determined by 6 different platelet function tests in patients on dual antiplatelet therapy after angioplasty and stenting for peripheral, coronary and carotid artery disease. One hundred patients showing high on-treatment residual ADP-inducible platelet reactivity in 2 or more tests will be randomized to receive either 75mg or 150mg of daily clopidogrel in addition to aspirin for 3 months. The aim of the present study is to investigate the effects of intensified antithrombotic therapy (150mg clopidogrel + 100mg aspirin daily) versus standard antithrombotic therapy (75mg clopidogrel + 100mg aspirin daily) in patients with decreased clopidogrel-mediated platelet inhibition after percutaneous intervention with stent implantation.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* angioplasty and stenting for peripheral, coronary or carotid artery disease

Exclusion Criteria:

* known aspirin or clopidogrel intolerance
* therapy with vitamin K antagonists (warfarin, phenprocoumon, acenocoumarol)
* treatment with ticlopidine, dipyridamol or nonsteroidal antiinflammatory drugs
* family or personal history of bleeding disorders
* malignant paraproteinemias
* myeloproliferative disorders
* heparin-induced thrombocytopenia
* severe hepatic failure
* known qualitative defects in thrombocyte function
* major surgical procedure within one week before enrollment
* platelet count \< 100.000 or \> 450.000/µl
* hemoglobin \< 8 g/dl
Finger Movement Training After Stroke

Human development as a species has been strongly associated with the ability to dexterously manipulate objects and tools. Unfortunately, current therapy efforts typically fail to restore fine manual control after stroke. The goal of this study is to evaluate a new intervention that would combine targeted electrical stimulation of selected nerves with use a soft, pneumatically actuated hand exoskeleton to enhance repetitive practice of independent movements of the fingers and thumb in order to improve rehabilitation of hand function after stroke.

The investigators will recruit stroke survivors in the subacute phase of recovery (2-18 months post-stroke). These participants will be involved in a 5-week intervention involving 15 training sessions. During these sessions, participants will train independent movement of the digits of the paretic hand. Evaluation of motor control of the paretic hand will occur prior to initiation of training, at the midpoint of the training period, after completion of training, and one month later.


Eligibility Criteria:
Inclusion Criteria:

* A single, unilateral stroke 2-18 months prior to enrollment
* Moderate to mild hand impairment, as determined by a rating of Stage 4-6 on the Stage of Hand section of the Chedoke-McMaster Stroke Assessment
* Visual capacity to discern specific shapes on the computer screen
* Capacity to provide informed consent

Exclusion Criteria:

* Rigid contractures in the joints of the upper limbs, or orthopedic issues precluding joint movement
* Hemispatial neglect (as assessed by the Behavioral Inattention Test)
* Excessive pain in the paretic upper limb (visual analog scale of shoulder pain \< 70)
Effectiveness Speech and Cognitive Therapy Implant Pre-cohlear Implantation

It has been shown that in deaf people, cortical reorganisation occurs and can accelerate age-related cognitive decline. Therefore, even though a number of Cochlear Implantation Reference Centres are setting up tests to detect cognitive disorders, these remain global and not very specific to deafness. Similarly, auditory rehabilitation could make cognitive decline reversible and bring about major changes in the cognitive functioning of patients which will be decisive for the effectiveness of speech therapy and the effectiveness of implantation. Indeed, it has been shown that, in the deaf postlingual patient, less neuronal activity in the auditory cortex and a reallocation of the cortical regions dedicated to auditory processing to visual tasks took place. This could subsequently influence the outcome of the cochlear implant. The aim of this study is therefore to evaluate the effectiveness of targeted speech therapy aimed at cognitive reorganisation on post-implant gain.


Eligibility Criteria:
Inclusion Criteria:

* Men or Women ≥ 18 years of age coming for consultation at the implementation centre.
* Subjects who can read and write French.
* Patients who are candidates for cochlear implantation and who have not had any contraindication to the operation following the pre-implant assessment.
* Ability to sign free and informed consent.
* Subjects with a smartphone or laptop that allows access to the application

Exclusion Criteria:

- Physical and cultural factors that may interfere with testing.
Effect of Dietary Fat Type in Combination With High Protein on Plasma Homocysteine Levels

In this study, the investigators address the research question of whether palm olein will have a positive influence on plasma total homocysteine levels in human volunteers provided with high-protein diets formulated from common Malaysian foods.

Hypothesis: There is a significant difference on the effects of the three experimental oils (palm olein, olive and coconut oil) on plasma tHy levels and the other markers of coronary heart disease (CHD) risk measured.

The experimental are comprise of 30% kcal fat, 20% kcal protein and 50% kcal carbohydrate. Each of the test fat \[palm olein (POo), virgin olive oil (OO) and coconut oil (CO)\] contributes to two-thirds of total dietary fat will be compared.

Three meals a day providing 2000 kcal, including breakfast, lunch and dinner will be provided for the 5-weeks period of each fat rotation.

45 volunteers are fed with normal cooking oil for 3 weeks for standardisation purpose. They were then stratified into 3 groups according to gender, homocysteine and cholesterol level. The volunteers will be randomized, blinded and will undergo a 3 arms crossover intervention. Each intervention will take 5 wk with 2 wk wash out in between.

Baseline blood samples will be taken while other blood samples will be collected at week-4 and -5 of the study.

Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy adult males and females aged 20-60 years, with BMI 23.0 -29.9 kg/m2, and free from any disease (will be decided through history taking, physical examination and biochemical tests).
* Not on any medication or treatment associated with reduction of CHD.
* Non-smokers and non heavy drinker or having smoking or alcoholic history.
* Not pregnant or lactating.
* Willing to adhere to the Dietary Guidelines to the study.

Exclusion Criteria:

* Obese \[Body Mass Index (BMI) ≥ 30\] or grossly underweight (BMI \< 18).
* Suffering from chronic diseases such as diabetes mellitus, CHD, cancer or any liver/renal disease.
* People with blood clotting problem.
* Hypertensive persons (systolic pressure \> 140 mmHg, diastolic pressure \> 90 mmHg)
Camostat Mesylate for Protein-losing Enteropathy After Fontan Operation

This study is phase 2 open-label, single-arm, multi-center clinical trial to evaluate the efficacy and safety of Camostat mesylate in patients with Protein-losing enteropathy after Fontan operation.


Eligibility Criteria:
Inclusion Criteria:

* history of protein-losing enteropathy after Fontan operation

  * more than 6 months after Fontan operation
  * more than 3 months of protein-losing enteropathy history (ascites, edema, diarrhea, etc) and less than 3.0 mg/dL of serum albumin without evidence of renal or liver disease

Exclusion Criteria:

* inability to take oral camostate mesylate
* hypersensitivity to camostate mesylate
* patients with taking similar medication or prohibited combination drug
* patients participating in other clinical trials
* patients with diet limitation
* patients with genetic disease such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
Activated Protein C in Severe Acute Pancreatitis

Activated protein C (APC)has been shown to reduce mortality in severe sepsis(Bernard et al. 2001b). The clinical picture of severe acute pancreatitis (AP) is similar to that of sepsis. The investigators conducted a randomised double-blinded placebo-controlled pilot study in AP patients (16+16) with the same dose of APC that has been proven to be efficacious and safe in septic patients.

The aim of the study is to investigate whether the APC replacement therapy diminishes the occurrence and severity of organ dysfunction in patients with severe AP. The effect of APC on inflammatory and hemostatic parameters is also assessed.

The study started in 2003 and was finished in 2007. The study was registered in The Helsinki University Central Hospital study register in 2003.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to hospital within 72 h of the onset of pain.
* Plasma amylase concentration more than three times the upper limit of the normal range and/or CT findings compatible with AP.
* Organ failure and \<48h of the onset of the first organ failure

Exclusion Criteria:

* HIV / B- or C hepatitis infection
* Pregnancy or breast feeding
* Active bleeding
* Increased risk of bleeding (thrombocytes \<30x10E9/L or INR\>3.0
* Gastrointestinal bleeding within 6 weeks or intracranial stroke within 3 months before the study
* Intravenous contrast extravasation or other signs (fresh hematoma) suggesting active hemorrhage within the pancreas or in the peripancreatic area on admission CT scan
* Use of antithrombin III within 12 h
* Use of acetylsalicylic acid or glycoprotein IIB/IA antagonist within 7 days / Thrombolytic therapy within 3 days
* Surgery requiring general or spinal anaesthesia within 12 h
* Previous pancreatic surgery
* Application of an epidural catheter within 48 h
Multicenter Study to Assess the Efficacy and Safety of Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) Versus Vehicle Cream for Actinic Keratosis of the Face

A Randomized, Double-Blind, Vehicle-Controlled, Multicenter Study to Assess the Efficacy and Safety of Methyl aminolevulinate hydrochloride (MAL) 16.8% cream (CD06809-41) versus vehicle cream in the treatment of thin and moderately thick, non-hyperkeratotic, non-pigmented actinic keratosis of the face and scalp when using daylight photodynamic therapy (DL-PDT).

This was a randomized, double-blind, vehicle-controlled, multicenter, parallel-group study in adult participants with clinically-confirmed mild to moderate AKs on the face and the balding scalp, to be conducted at approximately 60 clinical sites in the United States. Sites were selected to ensure that diverse daylight conditions represented in the study to understand the effects of latitude, elevation, and climate.

Eligibility Criteria:
Inclusion Criteria:

* Participants aged ≥ 18 years at the Screening visit.
* Participants had at least 4, but no more than 12, clinically-confirmed thin or moderately thick, non-hyperkeratotic, non-pigmented AKs located on the face (e.g., forehead, cheek, chin), and balding scalp.
* Female Participants of non-childbearing potential.
* Participants fully understood and signed an ICF before any investigational procedure(s) are performed.

Exclusion Criteria:

* Participants with pigmented AK in the treatment areas.
* Female participants who were pregnant, nursing, or planning a pregnancy during the study.
* Participants with a clinical diagnosis of a skin disease other than AK.
* Immunocompromised participants.
* Participants with any condition that may be associated with a risk of poor protocol compliance.
TODAY Genetics Study

The TODAY study group has prepared a protocol with the primary objective of collecting blood and phenotypic information to be used to explore relationships between candidate genes and type 2 diabetes (T2D), as well as obesity, insulin resistance, and cardiovascular complications of insulin resistance. Participation in the genetics study includes a blood draw for analysis of diabetes type and DNA extraction, as well as collection of basic family and medical history. Appropriate informed consent and assent are obtained from all participants to extract DNA and send blood, genetic material, and medical history to the Central Repository of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH). The data are kept indefinitely by the Central Repository. The NIDDK will issue requests for proposals (RFP) throughout the scientific community for research that may help in the development of new diagnostic tests, new treatments, and new ways to prevent diabetes and other related comorbidities.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes by ADA criteria (laboratory determinations of fasting glucose ≥ 126 mg/dL, random glucose ≥ 200 mg/dL, or two-hour oral glucose tolerance test (OGTT) glucose ≥ 200 mg/dL) documented and confirmed in medical record or a laboratory determination of HbA1c ≥ 7%. For asymptomatic patients diagnosed with diabetes with a normal fasting glucose but an elevated two-hour glucose during an OGTT, the HbA1c must be ≥ 6%.
* BMI ≥ 85th percentile documented at time of diagnosis or at screening.
* Age \< 18 at time of diagnosis.
* Signed informed consent and assent forms as appropriate.

Exclusion Criteria:

* Genetic syndrome or disorder known to affect glucose tolerance other than diabetes.
* Patient on medication known to affect glucose tolerance, insulin sensitivity or secretion within 60 days of the time of diagnosis. If diagnosis is confirmed after the patient has been off the medication for 60 days, the patient may be included. Exclusionary medications include but are not limited to

  1. inhaled steroids at dose above 1000 mcg daily fluticasone equivalent,
  2. oral glucocorticoids,
  3. antirejection or chemotherapy agents (e.g., tacrolimus, L-asparaginase),
  4. atypical antipsychotics.
Renal Resistive Index in Early Detection of Postoperative Acute Kidney Injury

The primary aim of our study was to investigate the role of renal doppler ultrasonography (USG) and preoperative/postoperative renal resistive index (RRI) in the early prediction of AKI. Our secondary aim is to evaluate perioperative parameters that may cause AKI, to determine the duration of intensive care unit (ICU)/hospitalization and 30-day mortality.

Our prospective, observational, cross-sectional study included patients with elective cardiac surgery under general anesthesia with prolonged CRP (\>70 min) and aortic cross-clamp (ACC) (\>60 min), \>18 years of age, without preoperative acute/chronic renal failure, and with preoperative/postoperative RRI measurements. Demographic data, comorbidities, medications, preoperative ejection fraction, admission hematocrit (HCT) and baseline serum creatinine (sCr), type of operation, and preoperative RRI were recorded. Intraoperative operation and CPB/ACC duration, blood product transfusion, urine output, amount of bleeding, fluid balance, use of vasopressor/inotropic agents and diuretics, and complications were recorded. RRI was measured by the same radiologist in the first postoperative hour. Urine output and fluid balance, vasopressor/inotropic agent requirement, diuretic use, sKr, HCT level and blood product transfusion were recorded for 3 days postoperatively. According to KDIGO guidelines, patients who did not develop CCI-AKI were divided into 2 groups as Group 1 (n:64) and patients who developed CCI-AKI were divided into Group 2 (n:26). In Group 2, renal failure stage, duration (acute/chronic) and RRT were recorded. ICU and hospital length of stay, postoperative complications and 30-day mortality were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Elective cardiac surgeries under general anesthesia with prolonged CPB (\>70 min) and aortic cross clemp (\>60 min) time
* \>18 years of age, without preoperative acute or chronic renal failure
* with preoperative and postoperative RRI measurements

Exclusion Criteria:

* Patients with known renal insufficiency,
* Patients with acute renal failure in the last 3 months
* Emergency surgeries,
* Patients with arrhythmia end-stage renal disease and renal transplant
* Patients Patients with short duration of CPB (\<70 min) and ACK (\<60 min)
* Failed Doppler ultrasonography imaging
Non-Invasive Preeclampsia Screening and Biobank

Women pregnant between 11-14 weeks gestation will be enrolled with blood samples collected to evaluate for preeclampsia.

To collect relevant pregnancy outcome data, medical history, and blood samples from pregnant women carrying a singleton fetus undergoing non-invasive screening for early, preterm and term pre-eclampsia (PE) starting at 11 weeks 0 days to 14 weeks 0 days (≥11 - ≤14) gestation in support of validating the Labcorp Preeclampsia ScreenTM assay. Data will be used to examine assay performance and develop new testing methods.

Eligibility Criteria:
Inclusion Criteria:

* Subject is female and 18 years of age and older;
* Subject provides a signed and dated informed consent;
* Subject is pregnant with a singleton pregnancy at ≥11.0 - ≤14.0 weeks' gestation;
* Subject agrees to provide the Sponsor access to any prenatal and postnatal screening or diagnostic test results and supporting data;
* Subject agrees to have UtAPI calculated during their SOC first trimester ultrasound and MAP collected at the first trimester SOC visit;
* Subject agrees to provide up to 25mL of whole blood at each trimester visit;
* Subject agrees to provide relevant medical and pregnancy/postnatal information including outcome.

Exclusion Criteria:

* Subject is unlikely to return for second and third trimester testing;
* Subject is unlikely to have pregnancy outcome data available;
* Previous sample donation under this protocol with the same pregnancy;
* Subject is participating in a blinded aspirin study or taking unknown doses of aspirin.
The Diagnostic Value of the First Clinical Impression of Patients Presenting to the Emergency Department (PREKEYDIA)

Finding a diagnosis for acutely ill patients places high demands on emergency medical personnel. While anamnesis and clinical examination provide initial indications and allow a tentative diagnosis, both laboratory chemistry and imaging tests are used to confirm (or exclude) the tentative diagnosis. The more precise and targeted the additional laboratory chemical or radiological diagnosis, the more quickly and economically the causal treatment of the emergency patient can be initiated.

One examination modality, which in addition to the medical history and clinical examination, could quickly provide information about the condition of the patient, their clinical picture and severity of illness, is the first clinical impression of the patient (so-called "first impression" or "end-of-bed view"). This describes the first sensory impression that the medical staff gathers from a patient. This includes visual (e.g., facial expression, gait, breathing), auditory (e.g., voice pitch, shortness of breath when speaking), and olfactory (e.g., smell of exhaled air, body odor) impressions. Clinical practice shows that a great deal of important additional information can be gathered through this first clinical impression, which, together with the history and clinical examination of the emergency patient, provides valuable clues to the underlying condition.

To date, however, only scattered data and study results exist in the medical literature on the value of the first clinical impression in the care of emergency patients. In the present prospective observational study, the study attempts to evaluate the predictive value of the first clinical impression in identifying a leading symptom and other important clinical parameters.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting to the emergency department between 2019-09-01 and 2020-02-28.

Exclusion Criteria:

* None.