cyrilzakka/clinical-trials huggingface dataset:
CD19-targeted CAR T Cells for Relapsed or Refractory (R/R) Large B-cell Lymphoma

This is an open-label, single-arm study to treat the adult R/R Large B-cell Lymphoma subjects with Relmacabtagene autoleucel (relma-cel) in China.

This is an open-label, single-arm study conducted in adult subjects with R/R LBCL in China to evaluate efficacy，safety and pharmacokinetics(PK) of relma-cel.

Relma-cel was approved by the China National Medical Products Administration(NMPA)in September 2021(Acceptance No:CXSS2000036)for the treatment of adult patients with R/R LBCL after second-line or more systemic therapy.The recommended dose is 1×10\^8 CAR+T cells.The indication for this application is R/R LBCL and the recommended dose is 1×10\^8 CAR+T cells.

Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years old;
2. Sign on the informed consent;
3. Subjects must have histologically confirmed Large B-cell Lymphoma;
4. Subjects had been treated with anthracyclines and rituximab(or other CD20-targeted antibodies) and had relapsed, failed to respond, or progressed after at least two lines of therapy including autologous hematopoietic stem cell transplantation(auto-HSCT);
5. Subjects have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification;
6. Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1;
7. Adequate organ function;
8. Adequate vascular access for leukapheresis procedure;
9. Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still express CD19;
10. Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of Relma-cel;
11. Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after the last dose of Relma-cel.

Exclusion Criteria:

1. Primary CNS lymphoma;
2. History of another primary malignancy that has not been in remission for at least 2 years;
3. Subjects has HBV,HCV,HIV or syphilis infection at the time of screening;
4. Active deep venous thrombosis(DVT)/Pulmonary embolism(PE),or active DVT/PE requires anti-coagulation within 3 months prior to signing the ICF;
5. Subjects with uncontrolled systemic fungal,bacterial,viral or other infection;
6. Presence of acute or chronic graft-versus-host disease(GVHD);
7. History of any serious cardiovascular disease or presence of clinically relevant CNS pathology;
8. Pregnant or nursing woman;
9. Subjects using of any chemotherapy,corticosteroid,experiment agents,GVHD therapies,radiation,allo-HSCT or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis;
10. Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol;
11. Received CAR T-cell or other genetically-modified T-cell therapy previously.
The Clinic Study to Prevent Pulmonary Embolism in Patients With General Anesthesia Operation in Perioperative Period

The purpose of this study is to investigate the prevention of Pulmonary Embolism in Patients who With General Anesthesia Operation in Perioperative Period.

Patients who received general anesthesia operation in Beijing Chaoyang Hospital affiliated to Capital Medical University were collected. The incidence of pulmonary embolism in perioperative period and age, gender,the surgery , clinical stage, clinical efficacy assessment will be further analyzed.

Eligibility Criteria:
Inclusion Criteria:

* The first time to accept the general anesthesia operation

Exclusion Criteria:

* Pregnancy.
* The function of liver and kidney disorder or serious abnormal electrolyte.
* The abnormal coagulation dysfunction and blood volume.
Exemestane As Treatment In Neoadjuvant Setting For Operable Breast Cancer Patients

To evaluate clinical and pathologic response rates following primary hormonal therapy by exemestane (Aromasin®)


Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal patients with unilateral breast cancer T2 to T4, N0-1, M0, non inflammatory, operable, hormonal receptors positive

Exclusion Criteria:

* Patients with bilateral breast cancer T4d, inflammatory, non operable, hormonal receptors negative
Preoperative PPI in Sleeve Gastrectomy

he purpose of this study is to study the effect of preoperative PPI in the early outcome of sleeve gastrectomy

In this study 200 morbidly obese patients will be included and will be undergone sleeve gastrectomy. the patients will be randomly assigned into 2 groups, group 1 will be receive PPI preoperative for 10 day and group 2 will not

Eligibility Criteria:
Inclusion Criteria:

* Morbidly obese patient with BMI more than 40 with or without co-morbidity
* Morbidly obese patient with BMI more than 35 with co-morbidity

Exclusion Criteria:

* Unfit patients for laparoscopic sleeve gastrectomy
* patients refuse to share in the study
* patients that already on PPI due to any indications
* revisional surgery for obesity
* previous upper abdominal surgery
Evaluating Safety and Efficacy of Umbulizer in Patients Requiring Intermittent Positive Pressure Ventilation

Randomized, control crossover study comparing Umbulizer's efficacy to traditional mechanical ventilators

Mechanical ventilators cost tens of thousands of dollars, rendering them difficult for low and middle income countries to procure. Given chronic shortages of these devices in places like Pakistan, patients are often ventilated manually with Ambu Bags for hours or days. This method is not suitable for long term ventilation and is extremely life threatening.

Umbulizer seeks to reduce preventable deaths due to ventilator scarcity by providing a reliable alternative. The device is accurate, low-cost, and portable, and is an ideal solution for treating patients with respiratory diseases in low-resource settings. The primary objective of this study is to test efficacy and determine non-inferiority of this device in comparison to ventilation provided by traditional ventilators. Secondary objectives of this study include:

1. Testing safety of the device for use over a predetermined period of time
2. Evaluating patient comfort during ventilation with this device
3. Assessing ease of use of this device for doctors and medical staff

Eligibility Criteria:
Inclusion Criteria:

1) Patients needing mechanical ventilation

Exclusion Criteria:

1. Patients with significant airway resistance (i.e. severe chronic obstructive pulmonary disease or asthma) where clinical investigator is concerned about gas trapping or barotrauma
2. Patients with very low lung compliance (i.e. severe acute respiratory distress syndrome or restrictive disease) where clinical investigator is concerned about problems delivering sufficient tidal volume or end expiratory pressure
3. Patients who experienced a myocardial infarction within the last 6 weeks
4. Patients who are determined by a clinical investigator to be too hemodynamically unstable to be enrolled
Bioequivalence Study of Nimesulide 100 mg Tablets

The objective of this study was to confirm if two formulations of nimesulide tablets are bioequivalent.

Test product was Eskaflam® (Nimesulide 100 mg tablets; GlaxoSmithKline) and reference product Mesulid® (Nimesulide 100 mg tablets; Syntex for Productos Roche). The single dosage was one tablet.

The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions.

The population was composed of 28 healthy volunteers, both genders, adults between 18-40 years.

The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.


Eligibility Criteria:
Inclusion Criteria:

Free will participation according to Mexican regulation, Helsinki Declaration, and Good Clinical Practice.

Healthy, between 18 and 40 years. Body Mass Index between 19 and 27 In good health by complete medical history and laboratory tests. Blood pressure 130-90/ 90-60 mm Hg; heart rate 55-100 beat per minute, respiratory rate 14-20 movements per minute.

Laboratory tests +/- 10% of normal interval (blood cytology, blood chemistry 27 elements, Hepatitis B and C antigens, HIV, urinalysis, anti-doping, pregnancy, electrocardiogram) -

Exclusion Criteria:

Alteration of vital signs Not complying with inclusion criteria History of cardiovascular, kidney, hepatic, muscular, metabolic, gastrointestinal (including constipation), neurologic, endocrine, hematopoietic (any kind of anemia), asthma, mental or organic disease. Those suffering from muscular trauma 21 days before the beginning of the study.

Requirement of any kind of medication during the course of the study, except study medication.

History of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer. Exposure to medications known as inducers or inhibitors of hepatic enzymes or administration of potentially toxic medication in the 30 days before the study beginning.

Administration of any medication in the 14 days or 5 half-lives (whatever longer) previous to the beginning of the study.

Hospitalization for any cause in the seven months before the beginning of the study.

Administration of investigational drugs in the 60 days before the study. Allergy to any antibiotic or non-steroidal anti-inflammatory analgesic. Alcohol ingestion or intake of beverages containing xanthines (coffee, tea, cocoa, chocolate, mate, cola drinks) or ingestion of charcoal grilled food or grapefruit or orange juice in the 72 hours before the hospitalization or tobacco smoking in the 72 hours before the beginning of the study.

Blood donation or loss =\> 450 ml in the 60 days before the beginning of the study.

History of drug or alcohol abuse. Positive pregnancy test. Special diet requirement, for instance vegetarian diet. Inability to understand nature, aims, and possible consequences of the study. Evidence of non-cooperative attitude during the study.

-
Improvement of EPO-resistance in Hemodialysis Patients With Chronic Inflammation by High Cut-off Hemodialysis

Chronic inflammation in dialysis patients is linked to cardiovascular mortality and clinical signs and symptoms, like the impaired response to erythropoiesis-stimulating agents (ESAs). This study aims to demonstrate that high cut-off hemodialysis is effective in reducing chronic inflammation and thereby improving response to ESAs.

Chronic inflammation in hemodialysis patients (micro-inflammation) is caused by multiple inflammatory stimuli and becomes apparent by elevated levels of biochemical markers such as CRP, IL-6, cellular activation markers etc. Chronic inflammation is linked to clinical signs and symptoms and cardiovascular mortality in dialysis patients. Inflamed dialysis patients show impaired response to erythropoiesis-stimulating agents (ESA) related to reduced iron utilization (functional iron deficiency) and elevated CRP levels are associated with a greater need for ESA to meet hemoglobin targets. If absolute iron deficiency can been excluded, EPO resistance is likely related to 'inflammatory block'.

The high molecular permeability of the Theralite high cut-off membrane allows for significant clearance of cytokines and other pro-inflammatory solutes by hemodialysis as shown in previous trials with high cut-off dialyzers. The study therefore aims to demonstrate that Theralite dialysis is effective in reducing chronic inflammation in ESRD patients, thereby improving EPO responsiveness. If this can be demonstrated, application of Theralite hemodialysis may reduce morbidity and mortality in the long term in ESRD patients.

Eligibility Criteria:
Inclusion Criteria:

* ESRD treated with chronic HD for at least 3 months
* Treatment with high-flux dialyzers for at least 3 months
* Age ≥18 years
* Receiving ESA to treat anemia for at least 3 months
* Impaired ESA responsiveness as indicated by EPO resistance index \> median of patients in study center
* Transferrin saturation (TSAT) ≥20% (last routine value prior to randomization)
* Serum ferritin ≥100 ng/ml (last routine value prior to randomization)

Exclusion Criteria:

* Acute infection ≤4 weeks prior to randomization
* HIV or hepatitis infection
* Catheter
* Chronic liver disease
* Active cancer
* Known blood dyscrasia (paraprotein abnormalities)
* Known bleeding disorders
* Bleeding episode ≤12 weeks prior to randomization
* Blood/red cell transfusion ≤12 weeks prior to randomization
* Hypoalbuminemia defined as serum albumin concentration below 35 g/L (last routine value prior to randomization)
* Participation in another clinical interventional investigation
* Pregnancy
* Inability to give informed consent
* Planned transplantation within study period +3 months
* Planned interventions requiring hospitalization \>1 week
Localization of Anatomical Structures Involved in Nodal Tachycardias by High Density Mapping.

The aim of the present work is to analyze the capacity of high resolution mapping systems to determine the precise location of the AV node and peri-nodal slow-conducting pathways, using standard recording parameters, but also off-line additional filter changes and additional techniques (conduction velocities, isochrones and dV/dt). The investigative team plan a prospective monocentric study.

Detailed high resolution mapping of the Koch triangle and neighboring areas will be collected through the RHYTHMIA HDx 3D electro-anatomical mapping system and the multipolar ORION catheter. This sample will consist of 2 groups of patients: the first will include patients referred for AVNRT ablation and the second will include control patients (without AVNRT), referred for another indication requiring similar mapping system. If visualized, position of the slow pathway and AV node will be compared with the ablation areas, which will be set conventionally under fluoroscopy.


Eligibility Criteria:
Inclusion Criteria:

Group 1: Patients without heart disease presenting with reciprocal tachycardia by intra-nodal reentry.

Group 2: Control subjects, without nodal tachycardia, without heart disease, and admitted for ablation of atrial fibrillation or ventricular extrasystoles on a healthy heart and with a 3D system.

Exclusion Criteria:

* Presence of underlying structural heart disease or history of atrial ablation or atrial tachycardia
* Minor or protected patient
* Patient under guardianship, curatorship or safeguard of justice
The Role of Fibrocytes in Acute Lung Injury

The important character of acute lung injury (ALI) is alveolar capillary membrane damage caused by different diseases, such as sepsis, trauma and shock. One of the important pathological stages is the varying degrees of interstitial fibrosis and semi-permeable alveolar membrane fibrosis. It has been proved that CXCL12/SDF-1 (stromal cell-derived factor-1) induces fibrocyte migration, and promotes fibrosis progression. Study indicated that inhibition of TLR4 receptor signaling pathway improves fibrosis progression induced by ALI, however, the role of fibrocyte in ALI is still unclear. The fibrocytes was significantly increased in asthmatic patients with pulmonary fibrosis, which companies with increased CTGF expression. Therefore, this project assumes that fibrocyte will differentiation to fibroblast/myofibroblast in patient with acute lung injury, which in turn leads to progression of fibrosis. The central hypothesis of this project is that peripheral progenitor cell fibrocytes play an important role in alveolitis caused by acute lung injury. The overall objective of this project is to study the role of fibrocytes in acute lung injury.


Eligibility Criteria:
Inclusion Criteria:

* Acute Lung Injury patients
* Above 20 years old
* Bilateral lung infiltrates
* PaO2/FiO2\<300mmHg
* PCWP\<18mmHg

Exclusion Criteria:

* Pregnant women
* Under 20 years old
* Hb\<8.0mg/dl
Rotator Cuff Repair (RCR) With and Without OrthoADAPT Augmentation

Prospective, randomized, multi-center, controlled study for patients undergoing open rotator cuff repair. Patients are stratified based on tear size to one of three groups. Each group is then randomized 1:1 to either repair with OrthoADAPT or repair without OrthoADAPT.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-70
* MRI confirmed full thickness or high grade partial thickness rotator cuff tear equal or more than 1 cm and involving the supraspinatus and/or infraspinatus tendons
* Tear is repairable by surgery using protocol prescribed fixation procedure
* Patient is able to sign and IRB approved study informed consent
* Patient is willing and able to return for follow-up appointments and study related procedures
* Patient is willing to comply with prescribed physical therapy regimen

Exclusion Criteria:

* Emergency, poly trauma patients
* Prior same shoulder surgery including rotator cuff repair except prior subacromial decompression or distal clavicle resection
* Shoulder pathology requiring concomitant procedures during the rotator cuff repair including Labral repair, anterior or posterior stabilization, and/or capsular plication or shift
* Cervical spine disease
* History of adhesive capsulitis in either shoulder
* Patient whose injury does or may involve litigation
* Diabetics
* Rotator cuff tear cannot be repaired by primary surgical means including superiorly migrated humeral head, retracted rotator cuff that cannot be mobilized to humeral head, end stage tears, rotator cuff tissue cannot retain sutures, any comorbidities that would directly or indirectly affect the reparability of the cuff
* Patients with grade 3 or 4 glenohumeral arthritis
* Patients with systemic collage disease
* Patients with a known hypersensitivity to equine derived materials
* Active or latent infection
* Chronic use of immunosuppressive agents
* Any oral or IM NSAID usage within 5 days before surgery
* Cancer patients
* Decisional impaired patients
* Pregnant women
Phase III Trial of DP Followed by FOLFIRI or the Reverse Sequence in Unresectable Gastric Cancer

To assess the optimal sequence of the palliative chemotherapy regimen (DP --\> FOLFIRI vs FOLFIRI --\> DP) in metastatic gastric cancer patients.

Gastric cancer is the second leading cause of cancer death worldwide and is the most common malignancy in Korea. Metastatic gastric cancer remains a therapeutic challenge for medical oncologists due to poor prognosis. A recent phase III trial comparing docetaxel-cisplatin-5-FU (DCF) to the reference arm of cisplatin-5-FU (CF) showed a significant superiority of DCF in terms of survival, time-to-progression, and response rate. However, because DCF regimen was associated with high incidence of toxicities, the regimen has not yet been widely accepted as the standard first-line chemotherapy for gastric cancer patients. Thus, the optimum front-line chemotherapy regimen should be extensively investigated in these patients to improve survival.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed metastatic adenocarcinoma of the stomach
2. Age ≥ 18
3. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
4. Life expectancy of at least 3 months
5. Adequate renal, liver, bone marrow functions
6. Adjuvant chemotherapy more than 12 months from the date of study entry
7. Written informed consent

Exclusion Criteria:

1. Active infection requiring antibiotics
2. Pregnant, lactating women
3. Brain metastasis
4. Systemic illness not appropriate for chemotherapy
5. Radiotherapy within 2 weeks before the study entry
6. Allergy to drugs used in the trial
Study for Evaluating Different Methods of Measuring Depression Treatment Response

Purpose of the study is to evaluate use of electronic diaries and voice acoustics for use in future depression clinical trial. Focus is on increased precision of measurement.


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of Major Depressive Disorder with symptoms of depression present at least 1 month
* Psychotropic medications currently not being taken

Exclusion Criteria:

* Failure to respond in past 5 years to antidepressant therapy of adequate duration and dosing
* Diagnoses of following conditions or disorders within past 6 months: generalized anxiety, obsessive compulsive, panic, post stress, anorexia, bulimia, alcohol or substance abuse or social anxiety disorder
* Diagnoses current or past of the following conditions or disorders: schizophrenia, psychotic disorder, delieium, dememtia, amnestic cognitive disorder, bipolar
teleRehabilitation for pAtients With ParkInson's Disease at Any mOment

The goal of this clinical trial is to test the feasibility and safety of a telerehabilitation and telemonitoring approach in people with Parkinson's disease at any stage. The main questions it aims to answer are: will patients with Parkinson's disease comply with the recommended level of training at home using an ad hoc developed telerehabilitation platform? • Will this training be safe and impact the patient's well-being perception? Participants will be given a tablet and instructed to access an online platform to observe different motor tasks presented in as many video clips by experienced therapists.They will be requested to perform the motor tasks per a predetermined protocol over 3 months. Their compliance with the recommended training will be checked by physiotherapists every 15 days during phone calls, whereas their daily level of motor activity will be recorded by a smartwatch.

In this cohort study, the feasibility and safety of a telerehabilitation and telemonitoring approach will be tested in people with Parkinson's disease at any stage. Enrolled subjects will be given a tablet through which they will log in with their own credentials to a telerehabilitation platform where a library of videoclips displaying as many different motor activities, grouped by difficulty (very easy - easy- advanced) and function domain (trunk alignment, balance, hand dexterity, speech articulation, ventilation...), will be available. Patients will perform the exercises according to a pre-determined training protocol, observing and imitating the tasks presented in the videoclips by experienced physiotherapists or speech therapists. A training duration of 45 minutes/day, 3 times/week for no less than 27 sessions (equal to 1200 minutes of total training) will be recommended. Moreover, subjects will be given a smartwatch to be worn 24 hours/ day, for at least 5 days/week. Every 15 +/- 3 days, one physiotherapist will call the patients to check the correct use of the devices, the level of adherence to the exercise program and the need for shaping the training difficulty to the user's skills.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson's disease (according to Movement Disorder Society criteria)
* Ability to provide written informed consent.

Exclusion Criteria:

* moderate-severe cognitive impairment (MoCA≤18)
* any other factor known to interfere with the ability to interact with the telerehabilitation platform (e.g. poor visual acuity, lack of family support);
* comorbidities with adverse impact on functioning or survival or affecting the performance of physical exercise (e.g. serious neoplastic diseases, cardiovascular diseases not controlled pharmacologically including arterial hypertension or hypotension, cardiac arrhythmias, heart failure, musculoskeletal diseases, dizziness or vertigo);
* severe depression or other neuropsychiatric disorders;
* expected need for adapting antiparkinsonian drug regimen over a 6 month period.