Kornimate/medical-research-clean huggingface dataset:
monoclonal antibody therapy in treating patients with recurrent hodgkin's lymphoma

Conditions: Lymphoma

Summary: rationale: monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. purpose: phase ii trial to study the effectiveness of monoclonal antibody therapy in treating patients who have progressive or recurrent hodgkin's lymphoma.

objectives: * determine the response rate of patients with recurrent hodgkin's lymphoma treated with monoclonal antibody hu1d10. * determine the duration of response and progression-free survival of patients treated with this drug. * determine the toxicity of this drug in these patients. outline: this is a multicenter study. patients receive monoclonal antibody hu1d10 iv over 2 hours. treatment repeats weekly for a total of 4 doses in the absence of disease progression or unacceptable toxicity. patients are followed at weeks 5 and 8 and then every 3 months thereafter. projected accrual: a total of 9-24 patients will be accrued for this study within approximately 12 months.

Eligibility criteria:
disease characteristics: * histologically confirmed hodgkin's lymphoma * progressive or recurrent disease after standard initial therapy * at least 1 unidimensionally measurable lesion (at least 15 mm by conventional techniques) * patients in first relapse must be ineligible or unwilling to receive high-dose therapy and stem cell transplantation * evidence of hu1d10 localization to reed sternberg cells by immunohistochemistry * no known brain metastases patient characteristics: age * 18 and over performance status * ecog 0-2 or * karnofsky 60-100% life expectancy * more than 6 months hematopoietic * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic * bilirubin normal * ast and alt no greater than 2.5 times upper limit of normal renal * creatinine normal or * creatinine clearance at least 60 ml/min cardiovascular * no symptomatic congestive heart failure * no unstable angina pectoris * no cardiac arrhythmia other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for 3 months after study participation * hiv negative * no known human anti-human antibody * no prior allergic reaction to compounds of similar chemical or biological composition to monoclonal antibody hu1d10 * no ongoing or active infection * no other uncontrolled concurrent illness * no psychiatric illness or social situation that would preclude study compliance prior concurrent therapy: biologic therapy * see disease characteristics * see chemotherapy chemotherapy * see disease characteristics * at least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * prior second-line (or greater) high-dose therapy and stem cell transplantation allowed endocrine therapy * not specified radiotherapy * at least 4 weeks since prior radiotherapy and recovered surgery * not specified other * no other concurrent investigational agents * no other concurrent anticancer agents or therapies

Keywords: recurrent adult hodgkin lymphoma
study of sotatercept for the treatment of anemia in low-or intermediate-1 risk myelodysplastic syndromes (mds) or non-proliferative chronic myelomonocytic leukemia (cmml)

Conditions: Anemia; Myelodysplastic Syndromes; Chronic Myelomonocytic Leukemia; Low to Intermediate-1 MDS; Myelodysplastic Syndromes (MDS); Chronic Myelomonocytic Leukemia (CMML)

Summary: the primary objective of this study is to determine a safe, tolerable and effective dose of sotatercept that results in the greatest frequency of improvement of anemia in patients diagnosed with low- or intermediate-1 risk myelodysplastic syndromes (mds) or non-proliferative chronic myelomonocytic leukemia (cmml).


Eligibility criteria:
inclusion criteria: * men and women ≥ 18 years of age * documented diagnosis of myelodysplastic syndromes (mds) or non-proliferative chronic myelomonocytic leukemia (cmml), white blood cells (wbc) ≤ 13,000 /mm\^3, world health organization (who) that meets international prognostic scoring system (ipss) criteria for low or intermediate-1 risk disease * anemia, hemoglobin (hgb) ≤ 9.0 g/dl or ≥ 2 units of red blood cells (rbcs) within 84 days * no response or loss of response to erythropoiesis-stimulating agents (esas) or erythropoetin (epo) \> 500 mu/ml * eastern cooperative group (ecog) score ≤2. * creatinine \< 1.5 \* upper limit of the normal (uln) * total bilirubin ≤3.0 mg/dl * aspartate aminotransferase (ast)/serum glutamic oxaloacetic transaminase (sgot) \& alanine aminotransferase (alt)/serum glutamic pyruvic (sgpt) ≤3.0 \* upper limit of norma (uln) * free of metastatic malignancy (other than mds) for ≥2 years * highly effective methods of birth control for females and males exclusion criteria: * chromosome 5q deletion * pregnant or breast feeding women and males who do not agree to use condom during the sexual contact with females of childbearing potential * major surgery within 30 days * incomplete recovery or incomplete healing of wounds from previous surgery * heart failure ≥3 (new york heart association (nyha)) * thromboembolic or myocardial infarction event within 6 months * concurrent anti-cancer cytotoxic chemotherapy * history of severe allergic or anaphylactic reaction or hypersensitivity to recombinant protein * known positive for human immunovirus (hiv) or infectious hepatitis type c or active infectious hepatitis type b * clinically significant anemia unrelated to mds * thrombocytopenia (\<30,000/ul) * uncontrolled hypertension * treatment with another investigational drug or device within 28 days prior to day 1 * prior exposure to sotatercept (ace-011) * any serious medical condition, lab abnormality or psychiatric illness

Keywords: ace-011 anemia dose-ranging intermediate-1 risk myelodysplastic syndromes low risk myelodysplastic syndromes (mds) multicenter open-label parallel phase 2 randomized sotatercept non-proliferative chronic myelomonocytic leukemia (cmml) hemoglobin transfusions
the effectiveness and tolerability of fentanyl matrix in chronic non-cancer pain; assessment of patient's pain treatment goal achievement

Conditions: Chronic Pain

Summary: the purpose of this study is to assess the effectiveness and tolerability of fentanyl matrix in chronic non-cancer pain.

this is a multicenter, prospective (a study in which the patients are identified and then followed forward in time for the outcome of the study), open-label (all people know the identity of the intervention), observational study intended to examine the effectiveness of fentanyl matrix through the degree of improvement of pain. fentanyl matrix is a transdermal (through the skin) system providing continuous delivery of fentanyl for 72 hours. fentanyl matrix will be administered to patients with chronic (prolonged) non-cancer pain under routine practice during 12 weeks. dose will be adjusted in accordance with patient's degree of pain and treatment response in the investigator's judgment.

Eligibility criteria:
inclusion criteria: * complain of chronic non-cancer pain that persists for \>= 3 months * pain inadequately controlled by previous treatment with narcotic analgesics (opium or opium-like compounds with potent analgesic effects, eg, tramadol, codeine, morphine, oxycodone) * women must be postmenopausal, surgically sterile, abstinent, or practicing an effective method of birth control if they have childbearing potential * male patients who agree to use a method of birth control and not to donate sperm for 1 month after the last dose of the study drug * a written informed consent for study participation exclusion criteria: * experience of treatment with fentanyl matrix within the past 4 weeks * no previous experience of use of narcotic analgesics * past or current history of alcohol or drug abuse * cannot use transdermal analgesics due to skin disorder * have serious psychiatric disorder and cannot complete overall study procedures and questionnaire in the judgment of the investigator

Keywords: chronic pain chronic non-cancer pain fentanyl matrix transdermal system
a study of absorption, metabolism, and elimination cc-90010 in participants with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: the purpose of this study is to assess the absorption, metabolism, and elimination of cc-90010 and its metabolites following a single oral dose of radiolabeled cc-90010 in participants with advanced solid tumors.


Eligibility criteria:
inclusion criteria: * males ≥ 18 years of age * has histological or cytological confirmation of advanced solid tumors including those who have progressed on standard anticancer therapy or for whom no other approved conventional therapy exists * eastern cooperative oncology group performance status (ecog ps) of 0 to 1 exclusion criteria: * persistent diarrhea national cancer institute common terminology criteria for adverse events (nci ctcae) grade ≥ 2 * history of concurrent second cancers requiring active and ongoing systemic treatment other protocol-defined inclusion/exclusion criteria apply

Keywords: cc-90010 neoplasms solid tumors [14c]cc-90010 bms-986378 bet inhibitor
a trial to investigate benralizumab in children with eosinophilic diseases

Conditions: Eosinophilic Granulomatosis With Polyangiitis (EGPA)

Summary: the main purpose of study is to assess the safety, tolerability, and pharmacokinetic (pk) of benralizumab.

this study is open-label, multicentre, basket study to evaluate the safety, pk, pharmacodynamic (pd), efficacy, and immunogenicity of repeat dosing of benralizumab subcutaneous (sc) every 4 weeks (q4w) in male and female children with rare eosinophilic diseases. paediatric participants with eosinophilic granulomatosis with polyangiitis (egpa) will be enrolled in the first cohort. additional cohorts in other eosinophilic diseases may be added in future protocol amendments. the study consists of 3 periods: 1. screening period: 1 to 4 weeks 2. open-label treatment period: 52 weeks 3. open-label extension period: at least 52 weeks (plus safety follow-up \[sfu\] weeks after last investigational product \[ip\] administration) all eligible participants will receive benralizumab sc q4w during the 52-week open-label treatment period. all participants who complete the 52-week open-label treatment period on ip will be offered the opportunity to continue into an extension period. the extension period is intended to allow each participant at least an additional one year of treatment with benralizumab.

Eligibility criteria:
inclusion criteria: all cohorts: * male or female patients must be aged 6 to \< 18 years of age at the time of signing the assent form and their caregiver signing the informed consent form. * body weight greater than (\>=) 15 kilograms (kg). egpa cohort: * therapy with corticosteroids: the prescribed dose of oral corticosteroids (ocs) (greater than \[\>\] 0.1 milligrams per kilogram per day (mg/kg/day), max dose of 50 milligrams per day (mg/day) must be stable (that is, no adjustment of the dose) for at least 4 weeks prior to baseline (visit 2). * immunosuppressive therapy: if receiving immunosuppressive therapy, the dosage must be stable for at least 4 weeks prior to baseline (visit 2). exclusion criteria: all cohorts: * any current malignancy or history of malignancy. * history of anaphylaxis to any biologic therapy or vaccine. * known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological, respiratory, or any other system abnormalities. * previous receipt of benralizumab in an interventional clinical study. egpa cohort: * diagnosed with granulomatosis with polyangiitis (previously known as wegener'granulomatosis) or microscopic polyangiitis. * egpa relapse: any deterioration in egpa and/or organ-threatening egpa that per investigator judgement renders patients unstable in their egpa within 3 months prior to screening (visit 1) and through first administration of ip at baseline (visit 2). * life-threatening egpa: imminently life-threatening egpa disease within 3 months prior to screening (visit 1) and through first administration of ip at baseline (visit 2), as per investigator judgement.
a clinical trial of precise positioning and intelligent operation of surgical robots to reconstruct cruciate ligaments

Conditions: Cruciate Ligament Rupture

Summary: 30 patients with the first rupture of the cruciate ligament were divided into two groups as 1:1. experimental group will be treated with arthroscopic robot-assisted navigation and positioning for cruciate ligament reconstruction. control group will be treated with conventional reconstruction. this project is used to verify the advantages of surgical robots assisting surgeons in cruciate ligament reconstruction surgery.

in this study, 30 patients with the first rupture of the cruciate ligament were recruited as the research objects, and the ratio of the experimental group and the control group was 1:1. patients in the experimental group will be treated with arthroscopic robot-assisted navigation and positioning for cruciate ligament reconstruction, and patients in the control group will be treated with conventional reconstruction. all subjects will undergo ct evaluation and clinical function evaluation. this project is used to verify the advantages of surgical robots assisting surgeons in cruciate ligament reconstruction surgery.

Eligibility criteria:
inclusion criteria: 1. 18-45 years old, with closed epiphyses; 2. for the first time, the knee joint is simply ruptured with a cruciate ligament and requires surgical reconstruction; it can be combined with meniscus injury, and the outerbridge injury score is ≤ ii; 3. there is no history of trauma or fracture of the ipsilateral knee joint; 4. the medial collateral ligament or the lateral collateral ligament is not damaged or only slightly damaged (no more than degree i). exclusion criteria: 1. bmi is less than 18.5 or greater than 35 kg/m2; 2. patients with moderate or severe knee degeneration; 3. those with limited flexion angle (\<120 degrees); 4. cartilage defect area is greater than 2 cm2 or outerbridge damage score\> grade ii.
a trial to evaluate the efficacy and safety of faropenem medoxomil in the treatment of chronic bronchitis

Conditions: Chronic Bronchitis

Summary: identifying the role of antibiotics in the treatment of subjects with a microbiologically documented acute exacerbation of chronic bronchitis (aecb) is the purpose of this clinical trial. the trial has been designed to evaluate the efficacy and safety of faropenem medoxomil versus placebo in the treatment of subjects with microbiologically documented aecb.

this is a multi-center, multi-national, prospective, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety/tolerability of faropenem medoxomil versus placebo in the treatment of subjects with a primary diagnosis of aecb. all subjects will have a pre-therapy sputum specimen obtained for culture and susceptibility testing.

Eligibility criteria:
inclusion criteria: * male or non-pregnant female outpatients age greater than or equal 35 years with significant copd (gold criteria i, iia or iib), chronic cough and sputum production and an acute exacerbation exclusion criteria: * gold criteria iii

Keywords: bronchitis aecb
single-cell sequence technology used to reveal heterogeneity of secondary hyperparathyroidism

Conditions: Secondary Hyperparathyroidism

Summary: this project intends to select cases that meet the research requirements, take secondary hyperparathyroidism, primary hyperparathyroidism and normal human parathyroid tissue, a total of three groups, 4 cases in each group, through the method of single-cell transcription and sequencing, construct a map of human parathyroid function types, reveal the gene structure and gene expression status of cells, and visualize the expression characteristics, intercellular heterogeneity, and heterogeneity of cell subsets of secondary hyperparathyroid cells in a hierarchical manner, draw a single-cell map, and compare the differences between groups. to explore the pathogenesis of secondary hyperparathyroidism. secondary hyperparathyroidism, parathyroid tissue of primary hyperparathyroidism and normal parathyroid tissue obtained by accident were collected, frozen and preserved, frozen tissue thawed, single-cell suspension was prepared and each cell was specifically labeled by the mozhuo genomics system, after oil breaking, polymerase chain reaction amplification, reverse transcription to obtain complementary dna, and a library of complementary dna that passed quality inspection was constructed to obtain high-quality data of parathyroid cells. cell ranger, r seurat package, and t-sne dimensionality reduction diagram were used to reduce the dimensionality, cluster, and visualize the data. in order to construct a single-cell atlas of parathyroid glands, investigators performed cluster analysis of similar cells according to the gene expression profile, and then visualized the data by t-sne. according to the results of cell clustering, the specific and highly expressed genes in each cell cluster were identified. cell populations were identified according to the expression of landmark genes, and the differences in cell types and proportions between groups were compared.


Eligibility criteria:
inclusion criteria: * study participants with a diagnosis of secondary hyperparathyroidism who underwent surgical treatment * study participants with a diagnosis of primary hyperparathyroidism who underwent surgical treatment * study participants who have obtained informed consent exclusion criteria: * other non-secondary hyperparathyroidism conditions such as primary hyperparathyroidism were excluded at the time of inclusion of study participants with essential hyperparathyroidism. * other non-primary hyperparathyroid conditions such as secondary hyperparathyroidism were excluded at the time of inclusion of study participants with essential hyperparathyroidism. * refusal of informed consent.
effect of inverse ratio ventilation during induction of general anesthesia on safe apnea time in obese patients

Conditions: Obesity

Summary: the purpose of this study is to investigate the clinical application value of inverse ratio ventilation in obese patients during induction of general anesthesia by studying the effect of inverse ratio ventilation on the safe apnea time.

inverse ratio ventilation(irv) can produce mean airway pressure(pmean)similar to external positive end expiratory pressure(peep) by increasing inspiratory time. moreover, the increase of pmean was not accompanied by the further increase of peak airway pressure (ppeak) and airway plateau pressure (pplat), while the application of external peep accompanied with the increase of pplat increased the risk of barotrauma . high level of peep increased cardiac load and decreased cardiac output. a number of studies have found that the hemodynamic stability of patients can be achieved when irv regulates the inspiratory / expiratory ratio in an appropriate range (i: e \< 2:1). therefore, the inverse ratio is considered to be superior to peep in terms of gas exchange and respiratory mechanics.

Eligibility criteria:
inclusion criteria: * obese patients, aged 18-65 years, of either gender, asa grade ii-iii, body mass index (bmi) \> 30 kg / m2, scheduled for general anesthesia under tracheal intubation, signed informed consent. exclusion criteria: * patients who need rapid sequence induction (rsi); patients with expected difficult airway; severe chronic respiratory diseases, such as tuberculosis, bronchitis, bronchial asthma and copd; patients with severe cardiovascular diseases, such as severe ischemic heart disease and pulmonary hypertension; patients with severe cerebrovascular diseases, such as cerebral hemorrhage and cerebral infarction; patients with abnormal basal metabolic rate, such as pregnancy, thyrotoxicosis, pheochromocytoma; and severe stomach reflux disease; patients with abnormal hemoglobin and hematocrit.

Keywords: inverse ratio ventilation safe apnea time
performance of six equations for estimating resting energy expenditure in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the present study evaluated the statistical and clinical performance of the six common equations in subjects with type 2 diabetes adopting indirect calorimetry as reference standard

all consecutive subjects with type 2 diabetes referred from june 2012 to december 2019 were eligible. they were excluded if data on ongoing therapy, anthropometric or laboratory parameters, or measured ree was not available or if presenting with conditions known to affect indirect calorimetry.

Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes * available resting energy expenditure assessed by indirect calorimetry exclusion criteria: * data on ongoing therapy (e.g. lifestyle measures with or without approved drugs), anthropometric or laboratory parameters (including white blood count, estimated glomerular filtration rate, tsh), or ree assessed by the means of indirect calorimetry could not be retrieved * presenting with conditions known to affect indirect calorimetry (e.g. patients with strenuous exercise on the day before, asymptomatic patients with severe chronic kidney disease (egfr \< 30 ml/min/ 1.73 m2), increased white blood count, or subnormal tsh)
eumycetoma long-term post-treatment follow-up study

Conditions: Eumycetoma

Summary: to assess the long-term recurrence rate of eumycetoma in clinical trial participants treated in the phase ii dndi-fosr-04-myc clinical trial.

the purpose of the long-term post treatment follow-up study is to collect data on recurrence of eumycetoma lesions in participants who previously participated in: a randomized, double blind phase ii proof-of-concept superiority trial of fosravuconazole 200 mg or 300 mg weekly dose versus itraconazole 400 mg daily, all three arms in combination with surgery, in participants with eumycetoma in sudan (dndi-fosr-04-myc). these data will provide additional information on recurrences after end of study (\>15 months) of the parent clinical trial (dndi-fosr-04-myc). the study is observational, since there is no intervention in this protocol, but assesses the outcome of the intervention of the parent trial.

Eligibility criteria:
inclusion criteria: 1. clinical trial participants who were previously enrolled and received investigational product (fosravuconazole) or standard of care treatment (itraconazole) in the dndi-fosr-04-myc clinical trial. 2. in trial dndi-fosr-04-myc had no recurrence of eumycetoma lesion before month 15. 3. able and willing to give written informed consent for participation in this study, prior to performance of any study procedures. exclusion criteria: 1. any condition that, in the opinion of the principal investigator or designee, would preclude provision of informed consent or interfere with achieving the study objectives.

Keywords: mycetoma madura foot madurella mycetomatis
the relationship between peripheral arterial disease and mitochondrial respiratory capacity

Conditions: Intermittent Claudication

Summary: current evidence cannot explain the clinical features of peripheral arterial disease only from the principle of reduced blood flow. explanations have therefore in addition been linked to mitochondrial dysfunction of skeletal muscles. this study will elucidate whether there is a relation between clinical variables of the different levels of arterial insufficiency in peripheral arterial disease and mitochondrial respiratory capacity.


Eligibility criteria:
inclusion criteria: * asymptotic peripheral arterial disease (ankle-brachial index \< 0.9), intermittent claudication (ankle-brachial index 0.4 - 0.9), or critical limb ischemia (ankle-brachial index \< 0.4) exclusion criteria: * diagnosed with intermittent claudication secondary to vascular insufficiency * warfarin or heparin usage * underwent a vascular intervention in the last 6 months * active cancer, renal- or liver disease

Keywords: blood circulation blood vessels mitochondria muscle, skeletal legs energy metabolism