Kornimate/medical-research-clean huggingface dataset:
treatment of mature b-all and burkitt lymphoma (bl) in adult patients. burkimab-14.

Conditions: Mature B-Cell Leukemia Burkitt Type; Burkitt Lymphoma (BL); Unclassifiable Lymphoma Between DCBL and BL

Summary: rituximab combined with a specific intensive chemotherapy is considered the standard treatment for newly diagnosed patients with mature b leukemia/lymphoma. however, the toxicity of this therapy is high. the purpose of this trial is to reduce the dose intensity of the chemotherapy blocks once the patient has achieved complete response. with this approach the investigators expect to maintain the efficacy and to reduce the toxicity of the chemotherapy, specially the rate of deaths in complete response.

patients younger than 55 years in complete response after two blocks of rituximab and specific intensive chemotherapy will receive four additional blocks of rituximab and attenuated chemotherapy (reduction by 33% of the dose of cyclophosphamide, methotrexate and cytarabine) followed by additional rituximab doses as consolidation. patients older than 55 years will receive the six blocks with attenuated chemotherapy.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * patients diagnosed with de novo mature b-all, burkitt lymphoma (bl). under physician's criteria, patients with unclassified b-lymphoma with intermediate characteristics between dlbcl and bl could be included. * candidate to intensive treatment. exclusion criteria: * other all subtype different from mature b-all/bl * severe complications not due to mature b-all/bl (eg, sepsis, pneumonia, shock or hemorrhage) at diagnosis. * renal failure not due to mature b-all /bl * heart or liver failure * severe lung disease * secondary mature b-all/bl * hypersensitivity to foreign proteins * previous treatment with cytotoxic drugs * pregnancy/breastfeeding * severe psychiatric disease * lack of social or familiar support

Keywords: mature b-all burkitt lymphoma adult
vitamin d analog in vitamin d 24-hydroxylase deficiency

Conditions: Idiopathic Infantile Hypercalcemia - Severe Form

Summary: preclinical evaluation of a vitamin d analog for the treatment of vitamin d 24-hydroxylase using fibroblast from patients with cyp24a1 mutation.


Eligibility criteria:
inclusion criteria: * biallelic mutation in cyp24a1 * consent exclusion criteria: * none

Keywords: cyp24a1 vitamin d
development and application of accurate detection technology based on multimodal data of breast cancer comobid depression

Conditions: Breast Neoplasms

Summary: this study is a prospective, observational clinical research aimed at establishing a multimodal database encompassing clinical information and gut microbiome data from a sample of over 1,000 breast cancer patients comorbid with depression. the research involves collecting cohort sample information from breast cancer patients with comorbid depression, as well as fecal, blood, and saliva specimens for metagenomic sequencing, untargeted metabolite detection, and cortisol level analysis, respectively. based on the collected multimodal data, diagnostic, efficacy prediction, and prognostic survival prediction models for breast cancer with comorbid depression will be developed. additionally, a precision prediction cloud platform will be designed and deployed to support data upload, model prediction, and result visualization.


Eligibility criteria:
inclusion criteria: * pathologically confirmed primary breast cancer; aged 18-80 years; no prior history of malignancy other than breast cancer; awareness of their breast cancer diagnosis; karnofsky performance status (kps) score \>70; willing to provide blood, fecal, and saliva samples with signed informed consent. exclusion criteria: * physician-diagnosed mental disorders before or after breast cancer diagnosis; severe chronic somatic diseases (e.g., central nervous system disorders, severe head trauma, substance abuse/dependence, intellectual disability, diabetes, gynecological diseases, cardiovascular diseases, thyroid disorders, etc.); presence of two or more primary malignancies of different tissue origins; central nervous system (cns) metastasis of breast cancer; clinically diagnosed digestive system diseases (e.g., enteritis, gastritis); use of antidepressant or anxiolytic therapy during the study; use of medications that alter gut function or metabolism during the study; pregnant or lactating women; radiotherapy or chemotherapy within the past 21 days; use of antibiotics, probiotics, prebiotics, or synbiotics within 3 months prior to the study; other reasons deemed unsuitable for participation by investigators.
the efficacy of clinical pilates exercises on individuals with lumbar disc herniation

Conditions: Lumbar Disc Herniation

Summary: the aim of the study is to determine the effects of clinical pilates exercises on the level of pain, functional status, flexibility, static and dynamic endurance of the truncus muscles and quality of life in patients with lumbar disc herniation.


Eligibility criteria:
inclusion criteria: * individuals, between the ages of 30-60, * have been diagnosed according to magnetic resonance imaging results, in one or several of the levels of l3-l4 / l4-l5 / l5-s1 in the case of bulging and protuberance lumbar disc hernia, * at least 6 weeks with back and leg pain, * those who will be able to participate in the exercise program regularly, * those who are not included in the physiotherapy program in the last 6 months,, * with mental, auditory and visual problems that will prevent communication will be included in the study. exclusion criteria: * individuals, with spinal stenosis, * having previously described lumbar spine surgery, * having severe neurological deficits, * having primary or metastatic spinal malignancy, * having vascular problem at a later stage in the lower extremity, * diagnosed with osteoporosis, * those who are pregnant, * having uncontrolled hypertension, * with anger-dependent anguish will not be included in the study.

Keywords: clinical pilates exercise lumbar disc herniation chronic low back pain
establishment of a early risk model of ecmo in children with ards

Conditions: ARDS

Summary: the key problem in the treatment of ards is refractory hypoxemia. extracorporeal membrane oxygenation (ecmo) is an extracorporeal oxygenation of venous blood to eliminate carbon dioxide and return to the body. it has been an important part of the rescue treatment for ards. this study intends to explore the timing of ecmo. the main research hypothesis is that the appropriate timing of ecmo treatment can improve the weaning success rate and survival rate of children with severe ards; it is expected to provide a basis for determining the best timing of ecmo treatment

severe acute respiratory distress syndrome (ards), especially those caused by severe viral pneumonia, is still an important factor in the death of children, with a case fatality rate of 55%. the treatment includes lung protective ventilation and advanced ventilation support, but the effect is still not ideal for severe patients. ecmo can effectively support the respiratory system and provide good oxygen exchange. however, the survival rate of ecmo treatment in children with ards has a large bias.one of the key factors is the uneven timing of ecmo activation, which significantly affects the prognosis.this study intends to design a multi-center, prospective, non-randomized controlled trial , through retrospective research to find relevant factors affecting the prognosis of ecmo treatment, and to screen key indicators related to the timing of intervention; through a prospective cohort study to screen good indicators and cut-off values suitable for starting ecmo , constructing and verifying comprehensive prediction models.

Eligibility criteria:
inclusion criteria: * acute onset; within 7 days of clinical insult * chest imaging (radiograph or computed tomography) findings of new infiltrates (unilateral or bilateral) consistent with acute parenchymal disease * edema not fully explained by fluid overload or cardiac failure * may present as new acute lung disease in setting of chronic lung disease and/or heart disease * oi≥16 * viral etiology is clear exclusion criteria: * perinatal lung disease * large intracranial bleed with mass effect or need for neurosurgical intervention * hypoxic cardiac arrest without adequate cpr * irreversible underlying cardiac or lung pathology (and not a transplant candidate) * pulmonary hypertension and chronic lung disease * chronic multiorgan dysfunction * incurable malignancy * allogenic bone marrow recipients with pulmonary infiltrates * hepatic or renal failure * pertussis infection in infants * fungal pneumonia * immunodeficiency

Keywords: ecmo ards pediatric
significance of circulating tumor cells in the treatment of gastric and rectal cancer

Conditions: Circulating Tumor Cells; Colorectal Cancer; Gastric Cancer

Summary: the primary purpose of this study is to compare both short-term and long-term treatment effect of laparoscopic vs. open approach on progressive gastric and rectal cancer, based on circulating tumor cell (ctc) test results as well as disease-free survivals, and figure out principles of laparoscopic approach for progressive gastric and rectal cancer. secondary purpose is to establish an evaluation system for laparoscopic surgery for progressive gastric and rectal cancer treatment using ctc as a biomarker.

laparoscopic surgery represents a milestone for treatment of gastric and rectal cancer, with advantages of minimal invasion and rapid recovery compared to open approach. however, for progressive gastric and rectal cancer, laparoscopic approach has not been officially promoted by nccn guideline (2015). over the past decade, circulating tumor cells (ctcs), originated from a tumor cell, have been identified as potential blood-based biomarkers capable of providing prognostic and predictive information. in the present study, the investigators utilize the ctcbiopsy® system (yzybio company, wuhan, china), which has been approved by cfda (chinese food and drug administration), to detect ctcs, and try to compare both short-term and long-term treatment effect of laparoscopic vs. open approach on progressive gastric and rectal cancer, based on circulating tumor cell (ctc) test results as well as disease-free survivals, and figure out principles of laparoscopic approach for progressive gastric and rectal cancer. secondary purpose is to establish an evaluation system for laparoscopic surgery for progressive gastric and rectal cancer treatment using ctc as a biomarker.

Eligibility criteria:
gastric cancer inclusion criteria: * gastric cancer of stage ii/iii exclusion criteria: * history of malignant tumors * gastric cancer of stage ⅳ * preoperative neoadjuvant chemotherapy * history of upper abdominal surgery * severe other contradictions of surgery rectal cancer inclusion criteria: * primary rectal carcinoma * single lesion * no metastasis * sphincter-saving surgery available exclusion criteria: * history of malignant tumors * acute bowel obstruction, bleeding or perforation * tumor over 6cm in diameter or in severe adhesion with surrounded tissues * severe other contradictions of surgery
immunogenicity and safety of live attenuated varicella vaccine combined with live attenuated je vaccine

Conditions: Japanese Encephalitis; Chickenpox

Summary: the purpose of this study is to observe the occurrence of adverse events and seroconversion rate, geometric mean titres (gmts) of live attenuated varicella vaccine，live attenuated je vaccine and live attenuated varicella vaccine combined with live attenuated je vaccine, respectively.


Eligibility criteria:
inclusion criteria: * parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent * participant is aged ≥ 1 year to ≤ 3 years * participant without previous history of chickenpox, zoster and epidemic encephalitis b * subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures * body temperature ≤ 37.5℃ exclusion criteria: * known allergy to any constituent of the vaccine * known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever * known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth * reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction * failed to the expanded programme on immunization(epi) * receipt of any vaccine in the 4 weeks preceding the trial vaccination * plan to receive any vaccine in the 4 weeks following the trial vaccination * known bleeding disorder * receipt of whole blood, blood plasma or immunoglobulin in the 5 months preceding the trial vaccination * reported the history of acute illness had need systemic antibiotics or anti-viral treatment of infections in the 7 days preceding the trial vaccination * an acute illness with or without fever (temperature ≥ 38.0℃) in the 3 days preceding enrollment in the trial * participation in any other interventional clinical trial * any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine
urodynamic study and stress incontinence

Conditions: Stress Urinary Incontinence

Summary: a trial to answer the debatabal question about the role of urodynamic study in surgical treatment for stress urinary incontinence.

group of patients complaining of stress urinary incontinence and candidate for sling surgery were randomaly divided into 2 groups either to have urodynamic study before surgery or not.

Eligibility criteria:
inclusion criteria: * stress urinary incontinence exclusion criteria: * mixed incontinence * recurrent cases

Keywords: urodynamic study stress urinary incontinence
effects of intranasal administration of oxytocin in adults with prader-willi syndrome

Conditions: Prader-Willi Syndrome

Summary: the investigator thinks that the oxytocin (ot) can improve durably and significantly the behavior disorders and thus the socialization but also the satisfaction and could thus be an interesting therapeutic alternative for the patients presenting a prader-willi syndrome (spw). although today several studies demonstrated the effects of the ot in various domains of the behavior, the investigator do not know either its specificity of action about the cerebral level, or its duration of action, or the optimal modalities of administration and in particular at patients spw.


Eligibility criteria:
inclusion criteria: * prader-willi syndrome genetically confirmed * absence of extension of the qt interval in the electrocardiogram * absence of hypokalemia exclusion criteria: * psychiatric troubles * anomalies of the heart rhythm in significant ecg * hepatic insufficiency * renal insufficiency * patients presenting a pregnancy or breast-feeding * high sensibility to ot * high sensibility to the excipients of the product * patients having family history of genetic pathology causing an extension of the interval qt * patients having risk factors of advanced twist

Keywords: oxytocin adults
a study to investigate the pharmacokinetics, safety and tolerability of voriconazole in children

Conditions: Neutropenia

Summary: this is a study to investigate the pharmacokinetics, safety and tolerability of several doses of voriconazole, intravenous and oral suspension formulations, in children


Eligibility criteria:
inclusion criteria: * children who require a systemic antifungal agent for the prevention of systemic fungal infection exclusion criteria: * children who are receiving medications which cannot be taken concomitantly with voriconazole.
rotator cuff surgery in athletes: from rehabilitation to return to sport

Conditions: Rotator Cuff Tears; Athletes; Return to Sport

Summary: the main goal of this project is to study and define a rehabilitative flow-chart for athletes' rehabilitation and return to sport made by a set of objective shoulder evaluation indicators that are easy to use in clinical context. enrolled patients will undergo supervised rehabilitation treatment for rotator cuff repair according to a standardized protocol (5 days/week) and will undergo four evaluation at different times. healthy subjects will undergo evaluations with the same timing as patients.

clinical, kinematic and shoulder muscle strength assessments to collect data useful to define objective criteria for progression between rehabilitation phases will be performed according to the following times: * t1 - 4-6 weeks after surgery: prom assessment, pain assessment at rest and during prom, constant-murley score (cms). * t2 - 6-12 weeks after surgery: arom assessment (flexion in scapular plane, abduction, external and internal rotation), pain assessment at rest and during prom and arom tasks, scapular humeral rhythm, cms. * t3 - 12-16 weeks after surgery: arom assessment (flexion in scapular plane, abduction, external and internal rotation), pain assessment at rest and during prom and arom tasks, scapular humeral rhythm, isometric strength assessment, cms; joint proprioception assessment (joint position sense). * t4 - 16-24 weeks after surgery: arom assessment (flexion in scapular plane, abduction, external and internal rotation), scapular humeral rhythm, isometric strength assessment, cms, joint proprioception assessment (joint position sense), movement speed and smoothness. enrolled patients will undergo supervised rehabilitation treatment for rotator cuff repair according to a standardized protocol (5 days/week) and will undergo the evaluations. healthy subjects will undergo evaluations with the same timing as patients.

Eligibility criteria:
inclusion criteria: * age between 18 and 65 years * mini mental status examination (mmse)\> 24 * acceptance and signature of informed consent exclusion criteria: * presence of other pathologies that can compromise the standard post-operative course (shoulder instability; reoperation for failed rotator cuff repair; neurological and cognitive problems)

Keywords: shoulder return to sport rehabilitation athletes rotator cuff rotator cuff injuries rotator cuff tears pilot study assessment
safety, tolerability, pharmacokinetics and -dynamics of multiple rising oral doses of bi 113823 in patients patients with osteoarthritis of the knee

Conditions: Osteoarthritis

Summary: the objective of the study is to investigate the safety and tolerability of bi 113823 in male and female patients with osteoarthritis, following oral administration of bi 113823 with repeated rising doses.


Eligibility criteria:
inclusion criteria patients with osteoarthritis exclusion criteria
comparison between the sbk microkeratome versus femtosecond laser in flap creation during lasik surgery for myopia

Conditions: Refractive Surgery

Summary: lasik is the most commonly performed refractive surgery worldwide. it has been shown to be safe and effective procedure with predictable results over long term follow ups. with the advancement of technology, sub-bowman keratomileusis allows thin flap of approximately 100 microns thickness thus preserving thicker stromal bed as compared to conventional lasik. the femtosecond laser corneal flap has th advantage of producing a flap of uniform thickness, adjustable flap diameter, relatively few complications. the disadvantages of this procedure is the high cost of surgery, development of bubbles in the corneal layer and anterior chamber which may affect pupil trackingduring the procedure. despite the emergence of femtosecond laser-assisted flap creation, mechanical microkeratomes remain the preferred choice in the majority of developing countries. recent studies have shown that sbk corneal flap has the same advantages as femtosecond laser flap regarding flap uniformity, regularity, and accuracy with less suction time and cost, but with its specific complications as well.

it is a prospective comparative non randomized interventional clinical study primary outcomes of this study include: 1. comparison between the sbk microkeratome versus femtosecond laser in flap creation during lasik surgery for myopia using anterior segment oct (as-oct) 1 month after surgery in each group of patients. 2. measuring corneal flap diameter using (as-oct) secondary outcomes: 1. measuring uncorrected and best corrected visual acuity after 1 day, 1 week, 1 month postoperative. 2. recording any related complications in each group.

Eligibility criteria:
inclusion criteria: * myopes (from -1 to -9), with astigmatism up to -4, normal corneal topography, central corneal thickness (cct) more than 500 microns, and stable refraction for at least 12 months. exclusion criteria: * cct less than 500 microns, any ocular pathologies, one eyed patients, history of systemic disease, intraoperative complications, and abnormal corneal topography.

Keywords: lasik, sbk, femtolaser, flap creation, myopia
a study to evaluate the efficacy and safety of ibi302 in subjects with namd

Conditions: Neovascular Age-related Macular Degeneration

Summary: the study is designed for multi-center,randomized,double-masked,active-contralled study to evaluate effective and security of intravitreal injection of ibi302 in subjects with neovascular age-related macular degeneration.


Eligibility criteria:
inclusion criteria: 1. signed informed consent must be obtained prior to study participation; 2. male or female ≥ 50 years of age at the time of signing the informed consent; 3. active subfoveal cnv secondary to namd, or active cnv with intra/subretinal fluid involving the fovea; 4. bcva of 19 to 78 etdrs letters (inclusive) in the study eye at baseline. exclusion criteria: 1. ocular disease: * any concurrent intraocular condition/systemic disease in the study eye at screening or baseline that, in the judgment of the investigator, may cause the participant fail to respond to the treatment or confuse the interpretation of study results; * total lesion area(including blood, atrophy, fibrosis, ped and neovascularization)\> 12 optic disc area (da) on ffa; * subretinal hemorrhage area \> 50% of the total lesion area, or subretinal hemorrhage area involving macular fovea ≥ 1 da; * fibrosis or atrophy area \> 50% of the total lesion area, or involving the fovea; uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmhg after standard treatment); * presence of active intraocular or periocular infection or inflammation; 2. ocular treatment: * anti-vegf or anti-complement therapy in the study eye within 90 days prior to baseline; * fundus laser photo-coagulation in the study eye within 90 days prior to baseline; * photodynamic therapy (pdt) in the study eye within 90 days prior to baseline; * history of vitreoretinal surgery, penetrating keratoplasty in the study eye; 3. general condition or treatment: * uncontrolled hypertension (defined as systolic blood pressure \> 160 mmhg or diastolic blood pressure \> 100 mmhg after standard treatment); * hba1c \> 8% within 28 days prior to baseline; systemic anti-vegf drug and anti-complement drug therapy within 90 days prior to baseline; * history of hypersensitivity to any component of the test article, control article, or clinically relevant sensitivity to fluorescein dye, povidone-iodine; * pregnant or lactating women; inappropriate for the study (e.g., substance abuse, inability or unwillingness to follow the trial protocol), as judged by the investig.