cyrilzakka/clinical-trials huggingface dataset:
RadiothErapy priMIng for CAR-T

The REMIT trial will investigate radiotherapy as a preferred bridging method prior to Tisagenlecleucel infusion in patients with relapsed or refractory Diffuse Large B Cell Lymphoma

The REMIT Trial is an open label, single arm phase IIa study investigating Radiotherapy as preferred bridging method prior to Tisagenlecleucel treatment in patients with relapsed or refractory Diffuse Large B Cell Lymphoma approved to receive CD19 CAR-T cells as per their licensed indication.

The trial will recruit 20 patients who have been approved to receive Tisagenlecleucel treatment and where the tumour is amendable to radiotherapy as per standard of care.

Trial subjects (patients) during a 14 day screening phase will have their metabolic tumour burden assessed by PET-CT and bridging radiotherapy will be planned. Bridging radiotherapy will commence immediately after leukapheresis with dose adjustments according to disease burden and localisation.

Disease areas requiring effective long-term control will receive full dose radiotherapy, 20 - 30Gy /5-15# and other areas will receive low dose radiotherapy, 4Gy / 2# for optimal tumour debulking and priming effects.

Standard lymphodepletion will be given day -5 to day -3 followed by Tisagenlecleucel infusion on day 0. A window of 14-21 days will be left from last dose of radiotherapy and day 0.

Patients will be followed up at 3 and 6 months after Tisagenlecleucel infusion for a minimum of 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. Age ≥ 18 years
3. Histologically proven DLBCL, including transformed follicular or marginal zone lymphoma
4. Measurable disease on cross-sectional imaging that is at least 1.5cm in the longest diameter and measurable in two perpendicular dimensions
5. Relapsed/refractory after 2 or more standard immuno-chemotherapies
6. Approved to receive Tisagenlecleucel as per the licenced indication
7. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
8. Disease accessible for repeat biopsies (Selected patients only)
9. Disease amenable to radiotherapy as assessed by the treating clinical oncologist
10. Willing and able to comply with the requirements of the protocol, including contraceptive advice as per the protocol

Exclusion Criteria:

1. Prior radiotherapy at location/dose that would interfere with application of radiotherapy or outcome measures in this trial
2. Women who are pregnant or breast feeding
3. Previous therapy with any genetically modified autologous or allogeneic T-cell immunotherapy, unless treated with doses of genetically modified autologous or allogeneic T-cell immunotherapy within an abandoned dosing cohort in a first in human dose-escalation phase I clinical trial
Repository for Sepsis and Postresuscitation Samples

The objective of this study is to find a new therapeutic strategy by investigating the serial serum samples of patients with sepsis or postresuscitation state.


Eligibility Criteria:
Inclusion Criteria:

* Age over 16 years old
* Admitted to ICU
* Diagnosed as having sepsis or as postresuscitation status
* Definition of sepsis: 2 or more SIRS criteria + infection is suspected
* Definition of postresuscitation status: Survived from non-traumatic cardiac arrest

Exclusion Criteria:

* refusal to participate
* DNAR status
Autonomic Regulation in Prader-Willi Syndrome

To evaluate autonomic regulation in patients with Prader-Willi syndrome with sleep-disordered breathing.

To evaluate the relationship between narcolepsy and sleep-disordered breathing, the natural course of untreated or treated sleep-disordered breathing and its impacts on autonomic regulation in patients with Prader-Willi syndrome with sleep-disordered breathing.

Eligibility Criteria:
Inclusion Criteria:

* 7-75 y/o Prader-Willi syndrome patients or healthy subjects
* can perform polysomnography, multiple sleep latency test
* orthostatic methods for autonomic function test
* can perform pulmonary function test.

Exclusion Criteria:

* less than y/o, or larger then 75 y/o
* cannot perform polysomnography, multiple sleep latency test
* cannot orthostatic methods for autonomic function test
* cannot perform pulmonary function test
* use of sedatives or drugs affecting autonomic function
Impact of Autologous Pure Platelet-rich Plasma in the Treatment of Tendon Disease

This is a randomized parallel controlled double-blind phase 2 clinical study.All subjects are recruited from the patients of rotator cuff tear, lateral epicondylitis or chronic achilles tendonitis. Patients will be randomly divided into three groups. Autologous pure platlet-rich plasma (P-PRP) and platlet-rich plasma (PRP) are purified from the peripheral blood .Patients of case groups will receive P-PRP or PRP injection once a week for three times while the control group received the same dose compound betamethasone injection. Follow up visit will occur at 1 month,3 months, 6 months,12 months after the last injection. Clinical quantitative assessment will measure by the visual analogue scale(VAS). The secondary outcomes are the constant-murley score(CMS) and the rating scale of the American shoulder and elbow surgeons(ASES) and the disability of arm shoulder and hand(DASH). The objective evaluation methods is that the examination of MRI or ultrasound were accomplished before the first injection and at 6 and 12 months afterwards.

All injection will be done under ultrasound guidance.

Eligibility Criteria:
Inclusion Criteria:

1. clinically diagnosed as rotator cuff tear, lateral epicondylitis or chronic achilles tendonitis;
2. symptom duration is over 3 months, non-steroidal drug treatment , rehabilitation treatment and other conservative treatment is invalid;
3. patient that can understand the clinical trials and signed the informed consent.

Exclusion Criteria:

1. patient that underwent other injection treatment within 6 weeks
2. some associated diseases (such as arthritis, synovitis, entrapment of related nerve, radiculopathy to the target lesion, generalized pain syndrome, rheumatoid arthritis, pregnancy, impaired sensibility, paralysis, history of allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue)
3. patient that enrolled other clinical trials within 3 months
4. history of drug/alcohol addiction, habitual smoker
Timing of Levodopa Treatment in Parkinson's Disease

The ELLDOPA study is a controlled clinical trial in patients with newly diagnosed PD to determine the optimal timing and dosing with levodopa (Sinemet or its generic equivalents).

The time to begin levodopa therapy has been controversial for many years, and yet every patient with PD, along with his/her treating doctor, needs to make this decision. One school of thought is that levodopa may lead to developing motor fluctuations and involuntary movements, and therefore its introduction should be delayed. The opposing school of thought argues that it is the worsening severity of the disease over time that makes the patient susceptible to these problems, and argues that the best response to levodopa is in the early stages of the illness when an improved quality of life can be optimized with levodopa.

Another debated issue is whether levodopa offers protection or is harmful to the remaining dopamine neurons. The latest studies in tissue culture show that when glia (the brain's supportive cells) tissue is present in addition to the nerve cells, the glia tissue becomes protective against any levodopa toxicity. Because glia tissue is present in brain, the argument has been made that levodopa should not be toxic in living brain tissue. A few studies have been carried out in animal models of PD. Two of these animal studies suggest levodopa is toxic to neurons, and two show that levodopa is not toxic and may actually have a protective effect. So there is no convincing or consistent evidence that levodopa damages dopamine neurons in humans or animal models of PD.

With this uncertainty as to what levodopa may be doing to the remaining dopamine cells in patients with PD, there is a strong need to make the determination in patients as to whether levodopa protects or worsens the progression of PD.

Primary End Point: Progression of PD as determined by change in a PD rating scale, the UPDRS, between baseline examination and examination at Week 42. These two examinations are conducted by a Primary Rater who sees the subjects only twice: at baseline and at Week 42, so as not to be influenced by any effects the subject may have experienced during the 40 week exposure to investigational medication.

Eligibility Criteria:
Inclusion Criteria:

* Early, mild PD, not requiring medications
* Age 30 or older
* Duration from time of diagnosis of PD: less than 2 years
* Hoehn \& Yahr Stage 1 or 2
* Exposure to levodopa or dopamine agonist of 14 days or less
Interscalene Block Versus Costoclavicular Block for Shoulder Surgery

Interscalene brachial plexus block constitutes the analgesic criterion standard for shoulder surgery. However, it is associated with a high incidence of hemidiaphragmatic paralysis (HDP) that may not be tolerated by patients with chronic pulmonary disease. This randomized controlled trial (RCT) will compare ultrasound-guided interscalene block (ISB) and costoclavicular infraclavicular block (CCICB) in patients undergoing arthroscopic shoulder surgery.

The main outcome is static pain at 30 minutes after arrival in the post anesthesia care unit (PACU) as measured by a numerical rate scale (NRS) from 0 to 10. Our research hypothesis is that interscalene and costoclavicular infraclavicular blocks will result in equivalent postoperative analgesia at 30 minutes in the PACU. The equivalence margin is set at 2 points.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing arthroscopic shoulder surgery
* American Society of Anesthesiologists classification 1-3
* Body mass index between 20 and 35

Exclusion Criteria:

* Adults who are unable to give their own consent
* Pre-existing neuropathy
* Coagulopathy
* Obstructive or restrictive pulmonary disease
* Renal failure
* Hepatic failure
* Allergy to local anesthetics
* Pregnancy
* Prior surgery in the corresponding side of the neck or infraclavicular fossa
* Chronic pain syndromes requiring opioid intake at home
PDA Treatment With Ibuprofen and Changes in Tissue Oxygenation.

Babies who are born very prematurely are often born with murmurs in the heart. In preterm babies, one of the most common causes of murmur is the presence of a PDA. This is the persistence of a connection that normally exists in the baby before it is born, connecting between the major blood vessels that leave the heart. In term babies, this channel closes shortly after birth when normal adult circulation is achieved. However, in preterm babies, the PDA can remain open, which can lead to multiple problems in the baby.

Our current standard of treatment in the Neonatal Intensive Care Unit (NICU) is to perform cardiac ultrasound (echocardiogram) in all babies less than 29 weeks gestation to diagnose the presence of hsPDA. We also use an echocardiogram to follow the PDA until complete closure. If present, the standard treatment in the NICU is to give medication, usually Ibuprofen, a non-steroidal anti-inflammatory drugs (NSAID), to close the PDA.

Near-infrared spectroscopy (NIRS) is a new type of device to detect oxygenated blood supply to the brain, kidney, and abdominal regions. This device is used to assess the effects of Ibuprofen on oxygen supply to these three regions.


Eligibility Criteria:
Inclusion Criteria:

* Preterm infants less than (\< )29 weeks gestation at birth
* Echocardiographic evidence of hsPDA (as outlined in the NICU PDA treatment guidelines) at 7-21 days of life requiring pharmacologic treatment as determined by the managing physician.

Exclusion Criteria:

* Not able to consent for any reason
* Preterm infants with congenital heart disease except for PDA, PFO (patent foramen ovale), small and restrictive ASD (atrial septal defect), or small VSD (ventricular septal defect).
* Preterm infants with lethal genetic malformations.
* Preterm infants with congenital abdominal wall defects (omphalocele, gastroschisis).
* Preterm infants with congenital or acquired brain anomaly.
* Infants who receive ibuprofen for PDA treatment during the first week of life will be excluded. We will recruit infants between day 7 and 21 only because high-dose ibuprofen is not indicated during the first week of life
* Preterm infants with contraindications to Ibuprofen therapy, including severe intraventricular hemorrhage (IVH), low platelet count \< 50,000 platelets per microliter, renal impairment with creatinine \>160 mmol/L or necrotizing enterocolitis (NEC) \> Stage 2 (using modified bell's Criteria).
* Preterm infants with spontaneous intestinal perforation (SIP).
* Acute kidney injury (defined as an increase in serum creatinine of 50% or more from the previous lowest value or a urinary output of less than 1 mL/kg per hr.).
Post-Op Quality of Life After Colorectal Surgery

The purpose of this study is to produce a user-friendly tool- in the form of a questionnaire - to accurately assess early quality of life in patients after abdominal colorectal surgery from the first day after surgery to 6 months after. The study will also compare this questionnaire to the other currently available assessment tools. Patients are invited to participate if they are undergoing abdominal colorectal surgery at University Hospitals of Cleveland.

The purpose of this study is to produce a user-friendly tool to accurately assess early quality of life in postoperative patients following abdominal colorectal surgery in the early postoperative period (from surgery to 6 months) that is practical for routine application. The study will also compare this tool to the current available tools, namely the Short Form (SF-36), the short form inflammatory bowel disease questionnaire (IBDQ), the Cleveland Clinic Global Quality of Life (CGQOL). Patients will be invited to participate if they are undergoing abdominal colorectal surgery at University Hospitals of Cleveland.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are 18 years of age and older
* Subjects of either sex
* Subjects who will undergo any colorectal abdominal surgery at University Hospitals of Cleveland
* Subjects who agree to participate in the study program and provide written informed consent
* Diagnoses of Crohn's disease, ulcerative colitis, rectal or colon cancer, colon or rectal polyps and diverticulitis

Exclusion Criteria:

* Patients in the middle of three part surgery or had recent surgery (i.e., back for stoma closure for J-pouch)
* Patients with diagnosis of rectal prolapse, condyloma or any other condition that cannot be performed abdominally with an open or laparoscopic procedure
* Patient who have undergone major surgery within the month prior to this colorectal surgery
* Pregnant women, minors, psychiatric patients and prisoners
Insulin Titration System Based on Deep Learning

This is an open-labeled, one-arm intervention trial to access the effect and safety of the Insulin Titration System Based on Deep Learning in patients with Type 2 Diabetes Mellitus.

The study enrolls 13 patients with Type 2 Diabetes in Zhongshan Hospital who are on treatment with insulin. After screening for the inclusion and exclusion criteria, eligible patients will receive insulin dosage titration set by the Insulin Titration System Based on Deep Learning in the intervention trial. The goal of insulin therapy was to achieve preprandial capillary blood glucose between 5.6-7.8 mmol/L and postprandial capillary glucose less than 10.0mmol/L. All patients are studied for 5 consecutive days or untill hospital discharge. For each patient, capillary glucose concentration was measured at 7 time points of fasting, after breakfast, before and after lunch, before and after dinner, and before bedtime a day using Glucometer (Glupad, Sinomedisite, China). Capillary glucose measurements were performed by the nurse staff according to standard procedures with a point-of-care testing device, which is integrated into the HIS system. And continuous glucose monitoring (CGM) was performed using flash glucose monitoring (Abbott Freestyle Libre, USA) placed on the upper left arm. This study will be conducted in the Department of Endocrinology, Zhongshan Hospital,Fudan University.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* age of 18-75 years
* HbA1c between 7.0% and 11.0%.

Exclusion Criteria:

* subjects with acute complications of diabetes, such as ketoacidosis or hyperglycemic hyperosmolar state;
* BMI ≥ 45kg/m2;
* women who are pregnant or breast-feeding;
* subjects with severe cardiac, hepatic, renal diseases; subjects with any psychiatric or psychological diseases;
* subjects with severe edema, infections or peripheral circulation disorders, receiving surgery during hospitalization;
* subjects who could not comply with the protocol
Dexmedetomidine Versus Standard Clinical Practice During Non Invasive Mechanical Ventilation

This study compare the effectiveness of dexmedetomidine as a sedative drug during NIV and the different strategies routinely used in patients with ARF of different aetiologies. Efficacy will be assessed based on absence of intubation, short term prognosis, and occurrence of medical complications.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age.
* Competent or with legal representative able to sign inform consent.
* Reversible ARF secondary to heart failure, COPD exacerbation, pneumonia, or at risk of pot-extubation failure\* who meet the criteria for starting NIV.
* Signs and symptoms of respiratory distress or
* Moderate to severe dyspnoea, grater than usual and/or
* Respiratory rate greater than 25 in COPD or greater than 30 in hypoxemic ARF and/or
* Use of accessory muscles and/or paradoxical breathing and/or
* Hypercapnic encephalopathy
* And changes in gas exchange
* PaCO2\>45 mmHg, pH\<7.35 and/or
* PaO2/FiO2 between 300 and 150.

  \*Patients at risk of post-extubation failure: Patients who meet at least one of the following criteria.
* Impaired consciousness.
* Age over 65 years
* Heart failure with EF \>30%
* Severe disease with an Acute Physiology and Chronic Health Evaluation (APSCHE) score \>12.
* Protracted weaning before extubation

Exclusion Criteria:

* Respiratory arrest, direct indication of OTI and IMV.
* Severe unstable comorbidity (myocardial ischemia with ejection fraction \<30%, arrythmia, uncontrolled hypotension defined as systolic blood pressure less than 90 mmHg with doses of norepinephrine\>0.5 mcg/kg/min and/or dobutamine\>10 mcg/kg/min).
* Inability to protect the airway: bronchial aspiration.
* Fixed upper airway obstruction.
* Tracheostomy.
* Undrained pneumothorax.
* Severe agitation or lack of collaboration of the patient despite medication administered.
* Facial burns or trauma.
* Facial surgery or anatomical changes which prevent mask fitting.
* Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
* Allergy to eggs, soya, or peanuts.
* HR\< 50 bpm not induced by beta- blockers.
* Advanced heart block (grade 2 or 3) unless paced.
* Acute cerebrovascular conditions.
* Increased intracranial pressure.
* Closed angle glaucoma.
* Myasthenia gravis.
* Concurrent use of CYP3A4 inhibitors (amprenavir, atazanavir, or ritonavir).
* Refuse to participate in the trial.
* Pregnant or nursing patients.
The Merit WRAPSODY AV Access Efficacy Study (WAVE)

The purpose of the study is to demonstrate the safety and efficacy of the Merit WRAPSODY Endovascular Stent Graft for treatment of stenosis or occlusion within the dialysis access outflow circuit


Eligibility Criteria:
Inclusion Criteria:

* Subject provides written informed consent
* Subject is male or female, with an age ≥ 18 years at date of enrollment.
* Subject is willing to undergo all follow-up assessments.
* Subject has a life expectancy ≥ 12 months.
* Subject is undergoing chronic hemodialysis.
* Subject has either a mature AVF or AVG in the arm.
* Target lesion(s) involves a de novo stenotic or non-stented restenotic lesion.
* Target lesion has ≥50% stenosis.
* Target lesion(s) reference vessel diameter is between 5.0 mm and 14.0 mm

Exclusion Criteria:

* Subject has a known or suspected infection of the hemodialysis access site, systemic infection and/or septicemia.
* Subject has a stroke diagnosis within 3 months prior to enrollment.
* Subject has a history of unstable angina or myocardial infarction within 60 days prior to enrollment.
* Subject is pregnant, breastfeeding, or intending to become pregnant within the next year.
* Target lesion is located within a stent / stent graft.
Pain After Proximal Digital Amputation Prevention

Finger amputations are common and may be complicated by debilitating nerve pain. This study seeks to determine if nerve pain after digital amputation can be more effectively prevented with either of two new surgical techniques-targeted muscle reinnervation (TMR) or regenerative peripheral nerve interfaces (RPNI)-compared to standard treatment by traction neurectomy (TN).

Patients who require proximal amputations will have the opportunity to enroll in the study, will be randomized intraoperatively to receiving one of the aforementioned treatments, and will be followed at 3 and 6 month for outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring single finger amputations at the level of the proximal interphalangeal joint or proximal (i.e., closer to the body than this joint).
* Patients have the capacity to complete the informed consent process

Exclusion Criteria:

* Patients less than 18 years of age, prisoner, or other vulnerable population
* Patients with significant concomitant ipsilateral extremity injuries that would confound study
* Patients requiring emergent, staged (guillotine-type) amputations of any kind
Oxidative Stress and Cardiac Arrest

Cardiac arrest is a major health problem reaching 375000 cases in Europe each year. Only 5 to 31 % survive after an out of hospital cardiac arrest (OHCA). The main complication after OHCA is the anoxic encephalopathy. Recently mild hypothermia has shown a beneficial effect on survival. But the mechanisms underlying these therapy are not clear.

Cardiac arrest is an example of ischemia reperfusion of the entire body. And it is well demonstrated that reperfusion generates an oxidative stress. But it has never been shown in a clinical setting.

The aim of the study is to evaluate oxidative stress after out of hospital cardiac arrest treated with mild hypothermia.


Eligibility Criteria:
Inclusion Criteria:

* Out of hospital cardiac arrest

Exclusion Criteria:

* refractory shock
* moribund patient
* resuscitation \> 60 minutes
* hypothermia \< 30 degrees