Kornimate/medical-research-clean huggingface dataset:
cd19/cd20 dual-car-t in b-cell lymphoma patients

Conditions: B-cell Lymphoma

Summary: this is a single center, single arm, open-label, phase i study to evaluate the safety and efficacy of cd19/cd20 dual-car-t cells in patients with refractory and relapsed b-cell lymphoma.

this phase i study is designed as a pilot trial evaluating the safety and efficacy of cd19/cd20 dual-car-t cell therapy in subjects with refractory and relapsed b cell lymphoma. subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of cd19/cd20 dual-car-t cells. safety and efficacy of cd19/cd20 dual-car-t cells therapy will be monitored. the purpose of current study is to determine the clinical efficacy and safety of cd19/cd20 dual-car-t cells therapy in patients with refractory and relapsed b-cell lymphoma.

Eligibility criteria:
inclusion criteria: 1. relapsed and refractory b-cell lymphoma with: relapsed or refractory disease after ≥2 lines of chemotherapy including rituximab and anthracycline and either having failed after autologous or allogeneic hematopoietic stem cell transplantation (asct); 2. patients must have evaluable evidence of disease, including minimal residual disease (mrd); 3. double positive expression of cd19 / cd20 in b cells; 4. ages 1 to 80 years, including boundary values; 5. ecog score 0-3 points; 6. women of childbearing age (15-49 years old) must receive a pregnancy test within 7 days prior to initiation of treatment and the results are negative; male and female patients with fertility must use an effective contraceptive to ensure 3 months after discontinuation of treatment during the study period not pregnant inside; 7. patients who voluntarily sign informed consent and are willing to comply with treatment plans. exclusion criteria: 1. patients with organ failure: * heart: nyha heart function grade iv; * liver: grade c that achieves child-turcotte liver function grading; * kidney: kidney failure and uremia; * lung: symptoms of respiratory failure; * brain: a person with a disability; 2. active infections that are difficult to control; 3. human immunodeficiency virus (hiv) positive; 4. liver and kidney function: total bilirubin \> 5 × uln, aspartate aminotransferase (ast) and alanine aminotransferase (alt) \> 5 × uln, serum creatinine clearance rate 60ml / min; 5. gvhd ≥ 2 or anti-gvhd treatment; 6. intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation; 7. pregnant or lactating women; 8. the patient does not agree to use effective contraception during the treatment period and for the next 3 months; 9. patients who participate in other clinical studies at the same time; 10. the investigator believes that there are other factors that are not suitable for inclusion or influence the subject's participation or completion of the study.
field evaluations of innovative tools for vector-borne disease control in conflict-affected communities

Conditions: Malaria; Childhood ALL; Vector Borne Diseases

Summary: the aim of this study is to determine the effectiveness of a new spatial repellent (called mesh) at repelling multiple disease vectors and, reducing clinical malaria rates in temporary shelters and camp settings. the design of the study will be a two-armed cluster randomised trial. by conducting the research in challenging camp settings in the north of nigeria, the mentor initiative aims to determine whether mesh can be effective in harsh camp conditions where communities are living in conflict area temporary shelters.


Eligibility criteria:
inclusion criteria: * shelters with 1 or more children from 6-10 years old * shelters with an adult/head of the household exclusion criteria: * shelters without children from 6-10 years old

Keywords: malaria cluster randomised trial children vector borne diseases nigeria internally displaced people camps
effectiveness of reduced frequency physical therapy in total knee arthroplasty

Conditions: Knee Osteoarthritis; Knee Arthritis; Knee Arthropathy

Summary: rehabilitation after total knee arthroplasty surgery involves physical therapy services to address limitations in range of motion, strength, and participation in normal daily activities. this investigation will compare the outcomes from standard physical therapy intervention in comparison to reduced frequency physical therapy sessions supplemented with in-home exercise equipment.

total knee arthroplasty (tka) is a common surgical procedure for individuals experiencing pain and reduced physical abilities related to knee pain, most commonly osteoarthritis. common physical impairments associated with post-operative tka rehabilitation include: reduced knee range of motion (rom), reduced strength, reduced participation in activities of daily living, and pain. tka surgery is routinely paired with physical therapy (pt) interventions post-operatively in order to facilitate recovery for patients electing to undergo this intervention. the total range exerciser (t-rex) is a medical device aimed at reducing the need for post-operative physical therapy services while promoting outcomes. a successful outcome after total knee arthroplasty requires symptom relief and restoration of physical function. measurement of pain and function can be achieved through patient-reported outcomes measures and objective functional testing. the knee injury and osteoarthritis outcome score (koos) is a patient-reported outcomes measure intended to capture the individual patient's perception of progress throughout the rehabilitative process. objective measurements of physical function are necessary to quantify the magnitude of physical impairment associated with the patient's perceived status. physical function can be measured through standardized assessment of knee rom, strength, and ambulation. the purpose of this study is to evaluate the effectiveness of standard physical therapy compared to reduced frequency physical therapy supplemented with the (t-rex) after in total knee arthroplasty in subjective and objective measurements of physical function.

Eligibility criteria:
inclusion criteria: * individual is to undergo tka by a licensed physician at participating hospital group * participating primary health insurance provider * patient is \< 64.5 years of age * willingness to participate in study protocol exclusion criteria: * previous or current history of cancer * high risk for cardiovascular disease as determined by the american college of sports medicine * individuals with documented mental, psychiatric, or emotional disabilities * inability to read and write in english

Keywords: total knee arthroplasty total knee replacement
study to collect in a real-world population data on the treatment pattern of secukinumab in adult patients with moderate to severe hidradenitis suppurativa (hs) in routine clinical practice in the russian federation

Conditions: Hidradenitis Suppurativa

Summary: anima-r is an observational, prospective, non-interventional, multicenter study to assess real-world effectiveness of secukinumab in the treatment of hidradenitis suppurativa (hs).

the index date will be the date of secukinumab initiation. during the study, data will be collected from patients receiving routine secukinumab treatment, which is representative of the actual patient population. the attending physician will decide whether to prescribe secukinumab based on the approved instructions for medical use in a routine clinical setting, regardless of the patient's participation in a non-interventional study.

Eligibility criteria:
inclusion criteria: 1. patients who provide written informed consent form (icf) to participate in the study. 2. male and female. 3. ≥ 18 years old. 4. diagnosis of moderate or severe hs (hurley stage and ihs4). 5. patient who initiated treatment with secukinumab no longer than 4 weeks prior to written icf. 6. decision for secukinumab prescription was made by the attending physician according to the approved national label during routine clinical practice, regardless of study participation. exclusion criteria: 1. any medical or psychological condition that may prevent the study participation, based on practitioners' decision-making. 2. participation in an ongoing clinical trial. 3. known or suspected severe hypersensitivity for secukinumab, formulation excipients, or injection device components (i.e., latex). 4. clinically significant infection exacerbation, including active tuberculosis. 5. patients with active inflammatory bowel disease (ibd). 6. age \<18 years. 7. pregnancy and breastfeeding. 8. patients who received any vaccine within 4 weeks prior to secukinumab initiation.

Keywords: hidradenitis suppurativa hs real-world data secukinumab
a phase ii clinical study of sb-480848 in dyslipidemic patients

Conditions: Atherosclerosis

Summary: the primary objective of this study is to examine the effects of sb-480848 on plasma lipoprotein associated phospholipase a2 (lp-pla2) activity in dyslipidemic patients during a 4-week treatment with sb-480848.


Eligibility criteria:
inclusion criteria: dyslipidemic subject who is currently undergoing statin therapy and no change in lipid-lowering therapy or dose during the 4 week prior to randomization exclusion criteria: 1. recent (i.e.,\<6 months prior to screening) cv event and/or vascular procedure defined as: a)st-elevation mi or non-st-elevation mi b)unstable angina c)coronary revascularization \[(percutaneous coronary intervention (pci) or coronary artery bypass graft (cabg)\] d)stroke of any etiology e)peripheral arterial disease with critical limb ischemia (resting pain or ischemic skin lesions, either ulcers or gangrene) f)resuscitated cardiac arrest 2. planned cabg or planned pci or planned major non-cardiac surgery within study period 3. no measurable lp-pla2 activity in plasma (\<10 nmol/min/ml) at screening 4. change in a lipid-lowering medication, regimen or dosage during the 4 week prior to randomization 5. poorly controlled dyslipidemia (ldl-c \>=160 mg/dl) at screening

Keywords: sb-480848 dyslipidaemia
contribution of a non medicamentous approach by hypnosis on quality of life in crohn disease

Conditions: Crohn Disease

Summary: evaluation of hypnosis therapy efficacy in addition to pharmacologic standard treatment of croh disease during remission by the evaluation of quality of life;

crohn disease is defined as an inflammatory chronic disease of the bowel characterize by intermittent flare-ups and remission periods. crohn disease is due to genetic and environmental factors such as stress. stress is an important aggravation factor of the disease symptoms which can stop a remission period and induce a relapse into a flare-up period. hypnosis is a non-medicinal technic which already show efficacy in the treatment of functional digestive troubles. these diseases are bio/psycho/social models such as crohn disease. hypnosis can reduce visceral pain sensibility, reduce stress and reduce pro-inflammatory cytokines liberation into intestinal mucosa. though, only few data are available on hypnosis interest in the treatment of crohn disease and inflammatory bowel diseases as it is often isolated clinical case report. one study on patients with rectocolitis in remission period has been done recently and show that hypnosis increased the duration of the remission period. the principal objective of this study is to evaluate hypnosis efficacy in term of quality of life for patients with crohn disease during remission.

Eligibility criteria:
inclusion criteria: * patient with ileal or colic crohn disease * stable treatment for crohn disease * clinical and biologic remission (normal c reactive protein and fecal calprotectin \< 100 µg/g) * patient living in grenoble area * informed consent form * social security affiliation exclusion criteria: * person under legal protection (articles l1121-5 and l1121-8 of public health code) * person in exclusion period of another study * hypnosis contraindication
cpap in sahs patients with hypertension

Conditions: Sleep Apnea Syndromes; Hypertension

Summary: study objective: to assess the nocturnal changes in mechanosensitivity and chemosensitivity in hypertensive sleep apnea-hypopnea syndrome (sahs) patients and in sahs patients with isolated nocturnal hypertension. to value the continuous positive airway pressure (cpap) effect on these parameters. design: controlled cross-over longitudinal study. settings: madrid metropolitan area. patients: day-night sustained hypertensive and isolated nocturnal hypertensive patients with sahs without previous treatment. at least 30 patients are needed. interventions: patients will allocate in each treatment arm (cpap vs. sham cpap) during three months. explorations will perform before and immediately after sleep at 0-, 3-, and 6-months of trial. measurements: 24-h urinary catecholamine, local vascular factors, angiotensin and aldosterone levels. diaphragmatic tension-time index, metabolic rate, hypoxic withdrawal test, and ventilatory and inspiratory neural drive responses to progressive isocapnic hypoxia.


Eligibility criteria:
inclusion criteria: * recent diagnosis of sleep apnea-hypopnea syndrome with an apnea-hypopnea index (ahi) \> 10 h-1 * no previous treatment for sahs or hypertension * diagnosis by 24-h ambulatory monitoring of blood pressure (ambp) of isolated nocturnal hypertension (nighttime blood pressure of ≥120 mm hg systolic or 70 mm hg diastolic and a daytime blood pressure \<135/85 mm hg) or day-night sustained hypertension (nighttime blood pressure of ≥120 mm hg or 70 mm hg diastolic and a daytime blood pressure of ≥135 mm hg systolic). exclusion criteria: * severe hypertension (\> 180/120 mmhg). * previous diagnosis of secondary hypertension. * myocardial infarction or stroke in the last three months. * severe diurnal sleepiness (epworth score \> 15) * previous diagnosis of chronic obstructive pulmonary disease, asthma, bronchiectasis, lung cancer, restrictive lung disease, chest wall disease or thoracic surgery. * previous diagnosis or clinical evidence of heart disease, neuromuscular disease or thyroid dysfunction. * morbid obesity (bmi \> 40 kg/m2) * respiratory infection in the last two months. * treatment with theophylline or systemic corticosteroids in the last two years. * excessive alcohol intake (\>40 g/day) * absence of social or familiar support.

Keywords: sleep apnea hypertension mechanosensitivity chemosensitivity adhesion factors
sentinel lymph node mapping post-injection site pain

Conditions: Breast Cancer

Summary: this is a pain survey study that will compare the level of discomfort experienced by breast cancer patients after injection of either technetium-labeled sulfur colloid or technetium-labeled tilmanocept, both fda-approved agents used for sentinel lymph node biopsy (slnb). breast cancer patients who are already scheduled for slnb as part of their original surgical plan will be asked to participate in this study and be randomized to receive either technetium-labeled sulfur colloid or technetium-labeled tilmanocept. after injection, patients will complete pain questionnaires to measure the amount of discomfort they are feeling during and after they receive the injection. there will be no change to the patient's treatment plan other than the addition of pain questionnaires. the investigators' hypothesis is that patients will feel less discomfort after injection of tilmanocept versus sulfur colloid.


Eligibility criteria:
inclusion criteria: * the patient has a diagnosis of biopsy-proven primary breast cancer or a diagnosis of pure ductal carcinoma in situ (dcis) who will be undergoing intraoperative lymphatic mapping as part of their standard surgical plan. * the patient has provided written informed consent before participating in the study, as has his/her responsible caregiver, if applicable. * the patient is a candidate for surgical intervention, with lymph node mapping being a part of the surgical plan. * the patient is greater than 18 years of age at the time of consent. * the patient has an performance status of grade 0 - 2. * the patient has a clinical negative node status at the time of study entry. * if the patients is of child bearing potential, the patient has a negative pregnancy test within 72 hours prior to administration of radiopharmaceutical, has been surgically sterilized, or has been postmenopausal for at least 1 year. exclusion criteria: * the patient is pregnant or lactating. * the patient has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes
high-flow oxygen for dyspnea in hospitalized cancer patients

Conditions: Cancer

Summary: the goal of this clinical research study is to compare high-flow oxygen, low-flow oxygen, high-flow air, and low-flow air in helping to decrease shortness of breath in cancer patients. researchers also want to learn if these therapies can help to improve lung function and quality of life.

study groups and procedures: if you agree to take part in this study, you will receive 4 different breathing therapies: * high-flow oxygen * low-flow oxygen * high-flow air and * low-flow air the order in which they will be given to you will be randomly assigned (as in a roll of dice). you will have an equal chance of being assigned to each group. neither you nor the study staff will know which therapy order you are assigned to. however, if needed for your safety, the study staff will be able to find out what you are receiving. all 4 breathing therapies should take about 80 minutes total to complete (10 minutes for each treatment with a 10 minute break between each treatment). you will receive the air or oxygen through small tubes placed in your nose. the respiratory therapist will be there to adjust the therapy to your comfort level. at the end of each breathing therapy, you will be asked about your shortness of breath and if you have any improvement. you will also be asked if you could tell whether you received oxygen or air after each therapy. after finishing the 4 breathing therapies, you will complete 2 questionnaires about which breathing therapy you liked and your thoughts about taking part in the study. these should take about 10 minutes total to complete. length of study: you will be taken off study if you no longer wish to take part, or if you need drugs to help with shortness of breath during the study. your participation in the study will be over after you complete the questionnaires. this is an investigational study. comparing high-flow air, low-flow air, high-flow oxygen, and low-flow oxygen to treat shortness of breath is considered investigational. up to 36 participants will be enrolled in this study. all will take part at md anderson.

Eligibility criteria:
inclusion criteria: 1. diagnosis of cancer 2. patients seen by palliative care, thoracic oncology, pulmonary medicine, or emergency care at md anderson cancer center 3. dyspnea numeric rating scale at rest \>/=3 of 10 (average over last 24 hour) 4. non-hypoxemic (i.e. oxygen saturation \>90% on ambient air) 5. able to communicate in english or spanish 6. age \>/= 18 years 7. able to tolerate high-flow oxygen/air exclusion criteria: 1. memorial delirium rating scale \>13 2. hemodynamic instability 3. respiratory failure requiring mechanical ventilation or non-invasive ventilation 4. frequent use of rescue opioids \>8x/day or rescue bronchodilators \>8x/day over last 24 hours 5. currently requiring high flow oxygen for oxygenation

Keywords: shortness of breath oxygen breathing therapies
influencing factors of intracranial hypertension in patients with bilateral transverse sinus stenosis

Conditions: Vertebral Venous Collaterals; Serum Uric Acid; Intracranial Hypertension; Bilateral Transverse Sinus Stenosis

Summary: bilateral transverse sinus stenosis (btss) is associated with intracranial hypertension (ih). however, not every btss patients presented with ih. the risk factors of ih in btss patients remained obscure. vertebral venous collaterals (vvc) were often found in patients with bilateral transverse sinus stenosis (btss). the purpose of this study was to investigate the physiological role of vvc in btss patients.

bilateral transverse sinus stenosis (btss) is characterized by narrowing of bilateral transverse sinus which resulted in obstruction of venous reflux. the majority of btss patients exhibited with intracranial hypertension (ih) which manifested as a triad of headaches, tinnitus and papilledema. stenting improved the symptoms in patients with transverse sinus stenosis (tss) and reduced the elevated intracranial pressure (icp). it is suggested that btss is one of the etiologies of ih. since an alternative pattern of venous reflux was observed in patients with occluded superior sagittal sinus, it is postulated that altered pattern of venous reflux also exists in the presence of btss. the drainage of cerebral veins consists of two major pathways: transverse sinus-sigmoid sinus-internal jugular vein and vertebral venous plexus. vertebral venous plexus is an extensive paravertebral system that provides direct venous communication between peritoneum and cranial cavity. the presence of vertebral venous collaterals (vvc) was reported in 108 consecutive patients. however, whether vvc is of physiological significance in btss patients remained unknown. this study was aimed to investigate the physiological role of vvc and whether it is involved in the regulation of ih and related clinical symptoms in btss patients. besides, it is presumed that serum uric acid (ua) may affect the formation of vertebral venous collaterals (vvc) and intracranial pressure (icp). it is reported that ua inhibits the endothelial no biological activity. high concentrations of uric acid (ua) suppresses circulating vegf in wistar rats and vegf secretion in human endothelial cells. it is presumed that serum ua may affect the formation of vvc and icp. the aim of this study is to investigate whether serum ua serves as an influencing factor of vvc and an indicator of ih in btss patients.

Eligibility criteria:
inclusion criteria: * btss confirmed by two of magnetic resonance venography (mrv), computed tomography venography (ctv) or digital subtraction angiography (dsa). exclusion criteria: * medicine related intracranial hypertension; * systemic inflammation; * moderate to severe stenosis in intracranial, carotid or vertebral arteries; * moderate to severe stenosis in intracranial or jugular veins other than transverse sinus; * intracranial lesions.

Keywords: vertebral venous collaterals serum uric acid bilateral transverse sinus stenosis intracranial hypertension