Kornimate/medical-research-clean huggingface dataset:
fcr versus fc alone in the treatment of chronic lymphocytic leukemia (cll) in relapsed patients

Conditions: Chronic Lymphocytic Leukemia

Summary: the purpose of this study is to provide treatment for patients who have chronic lymphocytic leukemia (cll), and to compare the use of rituximab added to fludarabine+cyclophosphamide (fc) with fc alone, to determine if rituximab lengthens the time a patient remains free of leukemia symptoms.


Eligibility criteria:
inclusion criteria: * age ≥18 years * established diagnosis of b-cell cll by nci working group criteria * ≤1 previous line of chemotherapy * expected survival \>6 months * acceptable hematologic status, liver function, renal function, and pulmonary function * negative serum pregnancy test for both pre-menopausal women and for women who are \< 2 years after the onset of menopause * written informed consent exclusion criteria: * prior treatment with interferon, rituximab or other monoclonal antibody * prior allogeneic bone marrow transplant (bmt) or autologous bmt or peripheral stem cell transplant (pbsct) or patients who are considered to be candidates for allogeneic or autologous bmt or psct as assessed by their treating physician * fertile men or women of childbearing potential not using adequate contraception * severe grade 3 or 4 non-hematological toxicity or prolonged (\> 2 weeks) grade 3 or 4 cytopenia on prior fludarabine or nucleoside analogue regimen * history of fludarabine-induced or clinically significant autoimmune cytopenia * history of other malignancies within 2 years prior to study entry, except for adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low-grade early stage localized prostate cancer treated surgically with curative intent; good prognosis ductal carcinoma in situ (dcis) of the breast treated with lumpectomy alone with curative intent. * medical conditions requiring long term use (\> 1 month) of systemic corticosteroids * active bacterial, viral, or fungal infection requiring systemic therapy * severe cardiac disease * seizure disorders requiring anticonvulsant therapy * severe chronic obstructive pulmonary disease with hypoxemia * uncontrolled diabetes mellitus or hypertension * transformation to aggressive b-cell malignancy. * known infection with hiv, hcv, or hepatitis b * treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to entering this study * known hypersensitivity or anaphylactic reactions to murine antibodies or proteins * any co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
autologous bone marrow stem cell therapy combined with psychological therapy and rehabilitation for autism

Conditions: Stem Cell Transplantation

Summary: the aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells combined with psychological therapy and rehabilitation for autism children

the aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells combined with psychological therapy and rehabilitation in the management of autism of 60 patients at vinmec research institute of stem cell and gene technology hanoi, vietnam from january 2017 to december 2018

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of autism according to the diagnostic and statistical manual-v diagnostic criteria for autistic disorder exclusion criteria: * epilepsy * hydrocephalus with ventricular drain * coagulation disorders * allergy to anesthetic agents * severe health conditions such as cancer, failure of heart, lung, liver or kidney * active infections * severe psychiatric disorders * rett syndrome * fragile x syndrome

Keywords: stem cell autism psychological rehabilitation
late ltp-like plasticity effects of tdcs in subacute stroke patients

Conditions: Stroke; Hemiparesis

Summary: rationale: about 80% of stroke patients suffer motor impairments, but current therapies have limited effects on motor recovery. therefore, investigating new potential therapeutic approaches is crucial. transcranial direct current stimulation (tdcs) is a form of non-invasive electrical stimulation where a weak current is applied through electrodes over the scalp. this stimulation is known to (1) induce changes in neuronal excitability -which can last up to one day with late ltp-like plasticity protocols in a polarity and site-specific manner, and (2) facilitate motor learning and stroke recovery. so far, several pilot studies have reported beneficial results from tdcs in both subacute and chronic stroke patients, but it's still unclear how tdcs should be repeated over multiple days to optimally enhance recovery and training effects. using a late ltp-like plasticity protocol could increase effectiveness of standard clinical care rehabilitation sessions and thus enhance the effects of rehabilitation. therefore, the investigators want to investigate how late ltp-like plasticity tdcs affects rehabilitation in subacute stroke patients. the outcome of this study can provide important guidelines on effective motor therapy during stroke rehabilitation. objective: identify the effect of late ltp-like plasticity on motor rehabilitation during the subacute phase after stroke. study design: double-blinded, randomized between-subjects trials. study population: subacute stroke patients. main study parameters/endpoints: the primary outcome measure is the upper limb motor function during the subacute phase after stroke.


Eligibility criteria:
inclusion criteria: * subacute stroke (within 1-4 weeks post stroke) * acute hemiparesis (fugl-meyer stage \< iv) with single thromboembolic non-hemorrhagic infarction documented by a neurologist * aged 18-79 exclusion criteria: * absence of voluntary movement (fugl-meyer stage \< iii) * head injury or the presence of intracranial metal or intracranial lesions * history of cranial irradiation * history of epilepsy * presence of a pacemaker * taking anticonvulsant or neuroleptic medication * substance abuse * inability to understand instructions
a study to assess the safety, tolerability and drug levels of bms-986172 in healthy and obese participants, including an assessment of the effects of food on bms-986172 absorption

Conditions: Healthy Participants

Summary: the purpose of this study is to evaluate the safety, tolerability and drug levels of bms-986172 and evaluate the effects of food on bms-986172 absorption.


Eligibility criteria:
inclusion criteria: * healthy participants as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, ecg, and clinical laboratory results as determined by the investigator or designee. * participants in part c must be first-generation japanese participants. for the purpose of this study, first-generation japanese is defined as native japanese or first-generation japanese living outside of japan for \<10 years. * bmi of ≥ 18 kg/m2 to ≤ 40.0 kg/m2, inclusive, at screening, except for high bmi cohort participants (part b) which will be restricted to a bmi range of ≥ 30 kg/m2 to ≤ 40.0 kg/m2. exclusion criteria: * inability to tolerate the oral lipid meal or the testing conditions on day -1, including but not limited to: bloating, nausea, vomiting, diarrhea, pain, or any discomfort due to oral lipid meal. * any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome. * history or presence of malignancy including hematological malignancies; participants with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 5 years will be allowed for inclusion, as judged by the investigator or designee. * any significant acute or chronic medical illness. * history of sars-cov-2 infection (either suspected or confirmed) within 3 months prior to signing consent * participants who have received a sars-cov-2 vaccine approved for emergency use authorization by the us fda that is not live attenuated may be considered for enrollment other protocol-defined inclusion/exclusion criteria apply

Keywords: healthy participants bms-986172
effectiveness and safety of ostenil® tendon in the treatment of pain and restricted mobility in tendon disorders

Conditions: Tendinopathy

Summary: pmcf study to further substantiate the effectiveness and safety of ostenil® tendon in the overall as well as indication-specific treatment of pain and restricted mobility in four different tendon disorders (patella tendon, peroneal tendon, medial epicondylus humeri and iliotibial band) in a real-life clinical setting when used according to the instructions for use.


Eligibility criteria:
inclusion criteria: * patient aged between 18 and 99 years * diagnosis of symptomatic tendinopathy (patella tendon, peroneal tendon, medial epicondylus humeri or iliotibial band) * physician's recommendation to use ostenil® tendon prior to recruitment * signed informed consent exclusion criteria: * presence of any contra-indication or precautionary condition listed in the instructions for use, i.e., * ascertained hypersensitivity to any of the ostenil® tendon constituents * known pregnancy or breast feeding * acute trauma * use of the following treatments (the given time intervals refer to the date of inclusion): * local\* ostenil® tendon or other hyaluronic acid (ha) treatment within the last 6 months * local\* platelet-rich plasma (prp) treatment within the last 3 months * local\* corticosteroid treatment (without time restriction) * local\* extracorporeal shock wave therapy (eswt) within the last 4 weeks * local\* phytotherapy (e.g., traumeel®) within the last 4 weeks * local\* surgical intervention (without time restriction) * systemic corticosteroid treatment within the last 4 weeks * repeated use of non-steroidal anti-inflammatory drugs (nsaid) and/or other analgesics within the last week * physiotherapy (therapeutic exercises and physical therapy), ortheses, transcutaneous electrical nerve stimulation (tens) or acupuncture within the last week * diagnosis of chronic inflammatory disease (e.g. rheumatoid arthritis, bechterew disease, crohn's disease, etc.) prior to inclusion * participation in a clinical investigation within the last 6 months * vulnerable patient (individual who is unable to fully understand all aspects of the study that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response \[including persons needing legally designated representatives, illiterate persons or persons with insufficient knowledge of local language\]) (\* local refers to the treatment of the study-relevant tendon)

Keywords: tendinopathy hyaluronan tendon hyaluronic acid
mmrf curecloud research initiative

Conditions: Multiple Myeloma

Summary: the mmrf curecloud research initiative, a direct-to-patient research effort aimed at enrolling 5,000 individuals from whom comprehensive molecular and immune analyses will be generated from blood specimens and the resulting data aggregated with the correlating clinical information. blood will be collected from all participants after electronic online consenting via a mailed blood kit designed for a mobile phlebotomy appointment. through the consenting process, participants will also be authorizing collection of their electronic medical records information.

more than ever, there is an urgent need for a deeper understanding of the clinical, molecular and immune parameters involved in multiple myeloma disease initiation, progression and response to treatment. such rich information, collected at the population level, is crucial to generate the evidence needed to ultimately make precision medicine a reality for all multiple myeloma patients. to this end the multiple myeloma research foundation (mmrf) is launching the mmrf curecloud research initiative, a direct-to-patient research effort aimed at enrolling 5,000 individuals from whom comprehensive molecular and immune analyses will be generated from blood specimens and the resulting data aggregated with the correlating clinical information. blood will be collected from all participants after electronic online consenting via a mailed blood kit designed for a mobile phlebotomy appointment. through the consenting process, participants will also allow the mmrf to collect their electronic medical records information. an important deliverable of the mmrf curecloud research initiative is a curated dataset of integrated genomic, immune and correlating clinical data that will be made available to support scientific investigations through the mmrf curecloud, a cloud-based platform with tools and capabilities for the seamless aggregation, integration and analysis of large collections of myeloma datasets.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed with active multiple myeloma 2. patients have signed an online consent form exclusion criteria: 1. patients who live outside the united states 2. patients with a diagnosis other than multiple myeloma or a known or suspected precursor to multiple myeloma
bendamustine plus rituximab versus fludarabine plus rituximab

Conditions: Non-Hodgkin's Lymphoma; Mantle Cell Lymphoma

Summary: the study addresses the question if a therapy with bendamustine plus rituximab is comparable (non inferior) with the well-tried combination of fludarabine plus rituximab with regard to event free survival (efs) in recurrent low malignant non-hodgkin and mantle cell lymphomas.


Eligibility criteria:
inclusion criteria: * patients with histological verified cd20-positive b-cell-lymphomas of the following entities: * follicular lymphoma grade 1 and 2 * immunocytoma and lymphoplasmocytic lymphoma * marginal zone lymphoma, nodal and generalised * mantle cell lymphoma * lymphocytic lymphoma (cll without leucaemic characteristics) * non-specified/classified lymphomas of low malignancy * recurrent disease (remission duration minimum 3 months), independent of type or quantity of prior therapies, except of rituximab containing regimens, or if remission duration is \> 1 year after rituximab containing regimen, or refractory to prior therapy (progression under therapy or during 3 months after completion), except refractory disease to purin analogs or bendamustine * need for therapy, except mantle cell lymphomas * stadium ii (bulky disease, 7.5 cm), ii or iv * written informed consent * performance status who 0-2 * histology not older than 6 months exclusion criteria: * patients not establishing all above mentioned prerequisites * option of a primary, potentially curative radiation therapy * patients refractory to rituximab containing regimens * comorbidities excluding a study conform therapy: heart attack during the last 6 months severe, medicinal not adjustable hypertonia severe functional defects of the heart (nyha iii or iv) lung (who grade iii or iv) liver or kidney (creatinine \> 2 mg/dl, got + gpt or bilirubin 3 x uln, except caused by lymphoma * active auto immunohemolytic anemia (aiha) * hiv positive patients * active hepatitis infection * severe psychiatric diseases * no compliance or non-compliance to be expected * pregnant or breast feeding women * anamnestic malignancies or secondary malignancies, not proven * cured/curable by surgery

Keywords: event free survival remission rates toxicity overall survival efficiency costs recurrent low grade
clinical presentation and outcomes in patients at risk of type ii myocardial infarction in the emergency department.

Conditions: Myocardial Oxygenation Imbalance; Myocardial Infarction

Summary: type 2 myocardial infarction has been reported in the universal definition of myocardial infarction for more than 10 years and most studies resulted in a high mortality rate. however, little to nothing is known for both criteria to define myocardial oxygenation imbalance threshold and the outcome of these patients presenting with myocardial oxygenation imbalance. the aim of this study is to compare the outcome at 6 months for patients admitted in the emergency department with a myocardial oxygenation imbalance, depending on whether a type 2 myocardial infarction occured or not.


Eligibility criteria:
inclusion criteria: * age 18 years old or older ; * at least one condition of myocardial oxygenation imbalance : * oxygen saturation below 90% ; * haemoglobin level below 130 grams/liter (g/l) for men, 120 g/l for women ; * persistent heart rate over 110 beats per minute, for more than 20 minutes ; * persistent systolic blood pressure below 90 millimeters of mercury (mmhg) for more than 20 minutes despite fluid resuscitation ; * persistent systolic blood pressure over 180 mmhg for more than 20 minutes. exclusion criteria: * patient admitted with type 1 myocardial infarction ; * patient presenting a condition for non ischemic myocardial infarction (pulmonary embolism, acute stroke, acute kidney failure, etc...) * patient who declines to participate; * pregnant or breastfeeding women ; * patient deprived of liberty (inmate, administrative protection)
wide-awake local anesthesia and no tourniquet (walant) in plastic surgery

Conditions: Upper Limb Wound; Lower Limb Wound; Anesthesia, Local

Summary: wide-awake local anesthesia no tourniquet (walant) was proposed and performed in hand operations. aim of this study is to present the use of walant in operations performed on the upper and lower limbs, evaluate its efficacy in terms of feasibility, total operation time, total operating room time, bleeding, patient discomfort and satisfaction and control for potential drawbacks. the hypothesis is that walant is a viable option in common operations performed by plastic surgeons on the upper and lower limbs.

wide-awake local anesthesia no tourniquet (walant) was proposed and performed in hand operations. little has been studied, regarding its indications and efficacy in general plastic surgery operations. aim of this study is to present the use of walant in operations performed on the upper and lower limbs, evaluate its efficacy in terms of feasibility, total operation time, total operating room time, bleeding, patient discomfort and satisfaction and control for potential drawbacks. the hypothesis is that walant is a viable option in common operations performed by plastic surgeons on the upper and lower limbs. a prospective study will be conducted comparing the use of walant in operations performed on the upper and lower limbs to the traditional use of tourniquet with general or regional anesthesia.

Eligibility criteria:
inclusion criteria: * upper or lower limb operation * indication for flap or skin grafting * operated by the principal investigator exclusion criteria: * other concomitant operations performed * known allergy to any of the ingredients of local anesthesia mixture

Keywords: walant plastic surgery upper limb lower limb
psycho-behavioral intervention for depression in chronic heart failure

Conditions: Depression

Summary: the study aims to explore the effectiveness of psycho-behavioral intervention on depressive symptoms among older adults with chronic heart failure. meanwhile, the effect on cardiac function and quality of life will also be explored.

depression has been one of the emerging health concerns for older adults, especially for those with chronic heart failure (chf). it was about 4-5 times more prevalent among patients with chf than healthy population and independently associated with poor outcome of chf. as suggested in the clinical management guideline of chf, it is imperative to create integrative intervention for older adults with chf, including timely detection and intervention, and ultimately improving the clinical outcome of chf. however, the approach appropriate for depression intervention among chinese older adults has yet been developed. this study aims to explore the effectiveness of psycho-behavioral intervention on depression associated with chronic heart failure in old age.

Eligibility criteria:
inclusion criteria: 1. between 60 -85 years old. 2. male or female. 3. diagnosis with depression as measured with phq-9 score of 5 and greater; 4. the subject is diagnosed with chronic heart failure according to their history, symptoms, signs, and adjuvant examinations (eg,echocardiography), in line with the diagnostic criteria for chronic heart failure presented in the china heart failure diagnosis and treatment guidelines, with nyha (new york heart association) grade ii-iii. 5. reading and writing competency for completing the rating scales. 6. sufficient physical condition, hearing and vision to ensure the completion of psychological behavior intervention. exclusion criteria: 1. currently taking antidepressant drugs, and drug dose is unstable. 2. with is a serious risk of suicide, suicide attempts and suicidal behavior (hamd17 score of 30 or above, or suicide subscale score of 3 and above，or suicide subscale score of mini of 6 or above). 3. intact cognitive function with csi-d score of less than 7. 4. having other major mental disorders, including alzheimer's disease, schizophrenia, schizoaffective psychiatric disorders, delusional disorders, undefined psychotic disorders, substance and alcohol abuse 5. planned heart surgery within 9 months. 6. unable to comply with psychological intervention due to serious physical conditions -
goal directed fluid therapy guided fluid management in pneumoresection

Conditions: Goal-directed Fluid Therapy

Summary: perioperative fluid management is a key component of anesthetic management during thoracic surgery. on one hand, fluid restriction could compromise perfusion of vital organs and surgical anastomosis. on the other hand, fluid overload could lead to cardiopulmonary complications, notably pulmonary edema, which carries a high mortality rate. perioperative fluid management to avoid postpneumonectomy pulmonary edema has been previously reviewed. therefore, to achieve the balance between preventing fluid overload and optimising organ perfusion, the practical index to guide fluid management, which can predict whether fluid loading will improve haemodynamic conditions in an individual patient, would be very valuable during lung surgery. perioperative goal-directed fluid therapy (gdft) is a cornerstone of tissue perfusion and oxygenation, and it can improve surgical outcomes. respiratory variations of arterial pressure \[i.e. pulse pressure variation (ppv) and systolic pressure variation\] can predict fluid responsiveness in mechanically ventilated patients under various conditions. therefore, pressure variations are increasingly being advocated for fluid management.this study will discuss the effects of pulse pressure variation(ppv) in different level during anesthesia on patients with oxygenation index and short-term prognosis undergoing video-assisted thoracoscopic surgery for pneumoresection.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists physical status i-iii; aged 18-60 years old; bmi 18.5 \~ 28 kg/m2 exclusion criteria: * refused to participate in the experiment, hepatic/renal/cardiac dysfunction, severe valvular disease, frequent arrhythmia, moderate anemia and severe electrolyte disturbance before operation.

Keywords: goal-directed fluid therapy thoracic surgery, video-assisted acute lung injury