Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of mak683 in adult patients with advanced malignancies

Conditions: Diffuse Large B-cell Lymphoma

Summary: the purpose of this phase i/ii study is to establish the maximum tolerated dose (mtd) and/or recommended phase 2 dose (rp2d) and to evaluate the safety, antitumor activity and pharmacokinetic (pk) profile of mak683 in patients with advanced malignancies such as diffuse large b cell lymphoma (dlbcl), nasopharyngeal carcinoma (npc) or other advanced solid tumors for whom no further effective standard treatment is available.

the purpose phase i of this trial is to characterize safety and tolerability and determine the maximum tolerated dose (mtd) and/or recommended phase 2 dose (rp2d) of mak683. the purpose of the phase ii of this trial is to evaluate the anti-tumor activity of mak683. phase ii part will not be opened.

Eligibility criteria:
inclusion criteria: 1. eastern cooperative oncology group (ecog): 0 to 2 2. relapsed or refractory diffuse large b cell lymphoma with measurable disease as determined by non-hodgkin's lymphoma cheson response criteria (2014) 3. advanced or recurrent/metastatic solid tumor, including nasopharyngeal carcinoma, castration-resistant prostate cancer, gastric cancer, ovarian clear cell carcinoma and sarcoma, with measurable disease as determined by recist 1.1. exclusion criteria: 1. other malignant diseases than the ones being treated in this study 2. severe and/or uncontrolled medical conditions that in the investigator's opinion could affect the safety of individual or impair the assessment of study result. 3. b-cell lymphoma patients who have received prior allogeneic stem cell transplant 4. patient have received anti-cancer therapies within defined time frames prior to the first dose of study treatment 5. symptomatic central nervous system (cns) involvement which are neurologically unstable or requiring increasing doses of steroids to control. 6. patient having out of range laboratory values defined as: 1) insufficient bone marrow function at screening: * platelets ≤ 50,000/mm3 * hemoglobin (hgb) ≤ 80 g/l * absolute neutrophil count (anc) ≤ 1000/mm3 2) insufficient hepatic and renal function at screening: * alp, alt, and ast \> 3 x uln (\>5 x uln if subject has liver metastases) * total bilirubin \>1.5 x uln * serum creatinine \> 1.5 x uln and/or creatinine clearance ≤ 50 ml/min

Keywords: mak683, dlbcl, eed - embryonic ectoderm development, ezh2 - enhancer of zeste homolog 2
the role of midkine in diagnosis of thyroid cancer

Conditions: Thyroid Cancer

Summary: 1. evaluation of the role of serum midkine in differentiating malignant from benign thyroid nodule 2. studying the level of serum midkine in relation to different thyroid cancer stages


Eligibility criteria:
inclusion criteria: patient with thyroid nodule exclusion criteria: 1. other known organ tumour 2. chemothyrapy 3. radiothyrapy c. sample size calculation
intravenous metoclopramide in the acute treatment of migraine: a double-blind, randomized, placebo-controlled trial

Conditions: Migraine Disorders

Summary: migraine attacks were frequently diagnosed in the emergency departments. also intravenous metoclopramide was a commonly used drug in the acute abortive treatment of migraine. however, the role of metoclopramide was based on three randomized, placebo-controlled studies, which were carried out with relatively few patients. those trials suggested that metoclopramide produced larger improvements in visual analog scale (vas) scores, however they revealed conflicting results and had significant methodological problems (risk of bias, allocation of concealment, intention-to-treat analysis). the investigators aimed to analyse the effects of intravenous metoclopramide in acute migraine attacks comparing with placebo.


Eligibility criteria:
inclusion criteria: * presenting to the emergency department with migraine attack (with aura or without aura, according to international headache society criteria, 2013) * the patients older than 18 years * patients who agree to participate to the study by reading and signing the informed consent document exclusion criteria: * the patients younger than 18 years * pregnants * patients taking any analgesic drugs last 2 hours * documented or declared allergy to metoclopramide * patients who are hemodynamically unstable * patients who do not agree to participate to the study

Keywords: migraine disorders migraine with aura migraine without aura pain management emergency department
an investigational drug, pf-02341066, is being studied in patients with advanced non-small cell lung cancer with a specific gene profile involving the anaplastic lymphoma kinase (alk) gene

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: this is a phase 2 trial that will evaluate the safety and efficacy of pf-02341066 in patients with advanced non-small cell lung cancer with a specific gene profile involving the alk gene. this trial will also allow patients from a phase 3 trial who received standard of care chemotherapy (study a8081007) to receive pf-02341066.


Eligibility criteria:
inclusion criteria: * histologically or cytologically proven diagnosis of non-small cell lung cancer * positive for the alk fusion gene (test provided by either a central laboratory. local laboratory may be used for certain cases) * may have received pemetrexed or docetaxel from previous phase 3 trial (a8081007) and discontinued treatment due to response evaluation criterion in solid tumors (recist)-defined progression. or, once the primary endpoint of study a8081007 has been analyzed and the results made available, at any time without recist-defined progression. * tumors can be measurable or non measurable exclusion criteria: * prior treatment with pf-02341066 * received no prior systemic treatment, chemotherapy or egfr tyrosine kinase inhibitor, for advanced non-small cell lung cancer * current enrollment in another therapeutic clinical trial

Keywords: lung neoplasms alk gene crizotinib
an act website for college students with insomnia

Conditions: Insomnia

Summary: college students experience higher rates of insomnia compared the general population, and accessibility and availability for the appropriate intervention is difficult due limited resources available to them in a college environment. theorefore, it is vital to offer an intervention that can be just as effective yet more accessible than other available treatments targeting insomnia. that is why this study will investigate the efficacy and feasibility of an online act intervention for insomnia among college students. specifically, is an online act for college students effective in treating insomnia? and, is an online act for college students feasible and acceptable in treating insomnia? participants will be randomized into one of two conditions: waitlist or online act guide. participants will receive questionnaires at baseline, post-treatment (4 weeks), and 1-month follow up.


Eligibility criteria:
inclusion criteria: 1. 18 years or older 2. enrolled in a 2- or 4-year college (includes graduate students) 3. fluent in english 4. have access to the internet 5. meets diagnosis for at least acute insomnia according to the diagnostic and statistical manual of mental disorders (dsm)-5 6. searching/wanting in treatment 7. currently residing in the us exclusion criteria: 1. diagnosed with another sleep disorder that is not insomnia 2. currently attending therapy for an emotional disorder (anxiety or depression) or insomnia 3. prescribed medications to treat insomnia or another sleep-inducing medication

Keywords: insomnia college student university student online
efficacy and safety of fixed combination therapy of vildagliptin and metformin (25/1000 mg bid) in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy (hba1c 7.0-9.5%)

Conditions: Diabetes Mellitus, Type 2

Summary: the present study is designed to evaluate the efficacy and safety of fixed combination therapy of vildagliptin and metformin (25/1000 mg bid) in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy.


Eligibility criteria:
inclusion criteria: * history of t2dm treated with metformin exclusion criteria: * fpg \>= 260 mg/dl (14.4mmol/l) other protocol-defined inclusion/exclusion criteria may apply

Keywords: type 2 diabetes, vildagliptin
comparing the efficacy of metronidazole and minocycline gels for the treatment of diabetic periodontitis patients

Conditions: Periodontitis; Diabetes Mellitus

Summary: this clinical study randomized 380 diabetic chronic periodontitis patients into 4 groups: scaling and root planning alone (group i), scaling and root planning plus metronidazole gel (group ii), scaling and root planning plus minocycline gel (group iii), and scaling and root planning plus both metronidazole and minocycline gels (group iv). periodontal measurements including probing depth, gingival color and texture, bleeding on probing, clinical attachment level, and recession were recorded at baseline, 7 days, and 15 days.

it was a clinical trial with four arms. the research was carried out at the pharmacology department, iimc riphah university, rawalpindi. the sample size was calculated to be 380 using the prevalence of disease, z-score, and 5% margin of error. written informed consent was obtained from the participants. the patients being treated for chronic periodontitis were randomly divided into four groups (i, ii, iii, and iv). patients in group i were subjected to scaling and root planning alone. group ii patients were given metronidazole gel following scaling and root planning. minocycline gel was locally applied subsequent to scaling and root planning in group iii patients. the combination of metronidazole gel and minocycline gel was administered after scaling and root planning in group iv patients. scaling and root planning of all the patients was done. periodontal probing depth, the color of the gingiva, texture of the gingiva, bleeding on probing, clinical attachment level, and recession were recorded for each patient at baseline visit, after 7 days, and after 15 days to determine and compare the efficacy of local administration of drugs.

Eligibility criteria:
inclusion criteria: * previously diagnosed diabetic patients on either hypoglycemics or insulin therapy suffering from periodontitis exclusion criteria: pregnant or nursing mothers patients with gestational diabetes alcoholics patients under any anti-inflammatory or antibiotic drugs (daily for ˃7 consecutive days) within the last two months of elimination before entering the study. known allergy to minocycline, or metronidazole. periodontal surgeries in the past smoking

Keywords: chronic periodontitis minocycline gel scaling and root planning metronidazole gel efficacy of local administration diabetes mellitus
short term aspirin on the biologic and immunologic changes of the fallopian tube

Conditions: Fallopian Tube Cancer; Fallopian Tube Infection

Summary: this study will evaluate the impact of low dose aspirin on normal fallopian tube fimbriae in women who have surgery to have their fallopian tubes removed. participants will take a low dose of aspirin for 2 weeks before their surgery. a portion of the removed fallopian tubes will also be collected for future research and routine pathology purposes.

subjects in this study will receive low dose aspirin for 14 days before undergoing surgery to remove fallopian tubes removed to determine whether aspirin decreases inflammation in the fallopian tube. subjects will also submit blood samples at their initial visit with their oncologist, at the time of surgery and at the pre-operative visit to measure inflammation markers and blood counts. a portion of the subject's fallopian tube will be collected for future research studies.

Eligibility criteria:
inclusion criteria: * women undergoing gynecologic surgery for presumed benign indications that includes the removal of their fallopian tubes. this may include sterilization procedures, hysterectomy or partial or full adnexectomy. * eligible women will have fulfilled their childbearing desires * age \> 21 considered low risk for prevalent fallopian tube cancer (not undergoing risk reducing surgery for a known brca mutation or other known hereditary predisposition syndrome, family history of ovarian cancer in a first degree relative. exclusion criteria: * males * women who have presumed or known gynecologic cancer * women less than 21 years of age * women currently on either regular aspirin therapy, non-steroidal anti-inflammatory drugs (nsaids), acetaminophen or chronic steroidal anti-inflammatory medications. * women with known bleeding diathesis or bleeding disorder. * women who do not consent for removal of both fallopian tubes. * women with a history of gastritis or peptic ulcer disease requiring treatment. (patients with a history of occasional h1 or h2 blocker use for gastro esophageal reflux disease are not excluded). * women with reported aspirin or nsaid allergy * women with asthma and/or nasal polyps
assessment of thigh muscle after a stretching program

Conditions: Assessment of Muscle Architecture and Tendon After Chronic Stretching Program

Summary: the purpose of this study is to establish, through ultrasound, measurements of the thigh muscles (biceps femoris and vastus lateralis)and the chronic effects of a static stretching program on the muscle-tendon unit these muscles.


Eligibility criteria:
inclusion criteria: * physically active male volunteers * soldiers of the army school of physical education of rio de janeiro, brazil * young men exclusion criteria: * any musculoskeletal disorder in the lower limbs * neurological or cardiovascular disease experienced previous to or reported during the study.
efficacy and safety study of tas5315 compared with placebo in participants with rheumatoid arthritis.

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to assess the efficacy and safety of tas5315 in combination with methotrexate in a 12 week or 36 week in participants with rheumatoid arthritis with inadequate response to methotrexate.


Eligibility criteria:
inclusion criteria: * have a diagnosis of ra according to 2010 acr/ eular rheumatoid arthritis (ra) classification criteria * have been treated with methotrexate (mtx) for at least 90 days prior to screening, and must be on a stable dose between 8 and 16 mg/week for at least 56 days prior to screening. * have an inadequate response to mtx * have a minimum of 6 swollen and 6 tender joints from 66/68 joint count * have hscrp of ≥ 0.6 mg/dl exclusion criteria: * have been treated with conventional synthetic disease-modifying anti-rheumatic drug, except for mtx, within 28 days prior to randomization * have an inadequate response to biologic disease-modifying anti-rheumatic drug or have been treated with 2 biologic treatment * have been treated with janus kinase inhibitors or other bruton's tyrosine kinase inhibitors * have a positive result for hepatitis b surface antigen/antibody, hepatitis b core antibody, hepatitis c virus antibody or human immunodeficiency virus antigen/antibody at screening * have been treated with oral steroids at dose above 10 mg/day of prednisone or prednisone equivalents * have a diagnosis of felty's syndrome * have a positive result of the quantiferon®-tuberculosis (tb) gold test or a t-spot ®-tb test at screening * have a positive result of β-d-glucan at screening
immediate breast reconstruction's increasing

Conditions: Breast Reconstruction; Breast Cancer

Summary: mastectomy in breast cancer is still a way of treatment. nowadays, the goal is to improve reconstruction's technicals. immediate breast reconstruction (ibr) is one of them, largely used in united states but less in france. however, igr (insitut gustave roussey) in paris just wrote a new protocole wich allows more ibr by including more patients. this study aims to compare complications in 2 groups: mastectomies followed by ibr and mastectomies without ibr. the second goal will try to estimate the proportion of eligible's patients to ibr, and to analyse their surgicals and oncologicals risk factors


Eligibility criteria:
inclusion criteria: * over 18 years * breast cancer * mastectomy * hopital de la croix-rousse * january 2016 and january 2020 exclusion criteria: * prophylactic mastectomy * male gender

Keywords: immediate breast reconstruction (ibr) mastectomy breast cancer
high flow nasal cannula vs low flow oxygen therapy in bronchiolitis

Conditions: Bronchiolitis

Summary: bronchiolitis is the most common respiratory infection of the lower respiratory tract that affects 11-12% of infants in their first year of life. approximately 1-2% of patients with bronchiolitis require hospital admission because of poor feeding and/or breathing difficulties. the standard treatment for bronchiolitis is represented by oxygen-therapy and hydration while neither steroids nor epinephrine nor bronchodilators are recommended. one of the techniques of administration of oxygen in bronchiolitis is represented by the high flow (hfnc) or by a system in which oxygen is delivered to 2l/kg through nasal cannulas. the hfnc provides humidification, heating and oxygen, ensuring a minimum positive pressure, reduces breathing load and allows for better nutrition. the main aim of therapy with high flows is to reduce the days of oxygen therapy and the cases of intubation. however, up to now, there have been few studies on the use of hfnc in pediatric emergency units. the cochrane review on this topic, updated in may 2013, included only one randomized controlled trial (rct) on a pilot study of 19 subjects comparing hfnc with oxygen administered via "head box". the oxygen saturation was higher in children hfnc after 8 (00% versus 96%, p=0.04) and 12 hours (99% vs 96%, p=0.04) but similar in both groups at 24 hours. the authors concluded that the available evidence is insufficient to determine the effectiveness of hfnc. the aim of this study is to evaluate in a large number of cases the effectiveness of treatment with high flow versus standard treatment, in children with bronchiolitis referred to a pediatric emergency department.


Eligibility criteria:
inclusion criteria: * diagnosis of bronchiolitis * age \>28 days and \<6 months * oxygen saturation (sao2) \<92% * respiratory rate \>60 breaths/min * dyspnea with respiratory distress assessment instrument (rdai) score ≥8 * daily milk or food intake less than 2/3 than normally assumed exclusion criteria: * chronic diseases or syndromes * respiratory diseases (i.e. bronchopulmonary dysplasia) * heart diseases * preterm birth (before 36 weeks of gestational age)

Keywords: bronchiolitis high flow nasal cannula oxygen therapy
home usage of conception kit instructions

Conditions: Healthy

Summary: patients will use the conception kit in their home and fill out a 22 question questionnaire in order to demonstrate their knowledge of the method of usage as described in the instructions and on the website: www.conceptionkit.com.

patients will be given a conception kit and take the kit home and read the instructions and if needed consult the website. the patient will then complete a 22 question questionnaire in order to demonstrate their knowledge of the method of use. all components have 510k clearance. this study is a validation of the instructions for use (ifu) only. opk class i device 21cfr 862.1485, conception cap k993953, pregnancy test kit k974059, semen collection device k902936 (21cfr 884.5300), conception kit has ce marked by gmed. (certificate 2037) conceivex is an iso 13485: 2003 company

Eligibility criteria:
inclusion criteria: * women who are actively trying to become pregnant exclusion criteria: * women who are contraindicated for a pregnancy

Keywords: infertility pregnancy conception conceive conceiving trying to conceive get pregnant conception kit conception cap fertility women who are actively trying to become pregnant
effectiveness of betaserc® (betahistine dihydrochloride) in patients with vestibular vertigo in routine practice

Conditions: Vertigo

Summary: the purposes of this international post-marketing observational program is to investigate effectiveness of betahistine dihydrochloride (betaserc®) tablets and assess the course of vestibular vertigo after treatment discontinuation in population of russia and ukraine outpatients suffering from vestibular vertigo in pragmatic clinical settings. exploratory analyses of results from both participating countries may be expected to provide insights about the subjective circumstances of vestibular vertigo patients in a wider than usual range of gender, underlying icd-10 diagnosis, national and cultural situations.

a prospective, multicentre, non-interventional, non-randomized, non-controlled, single arm, post-marketing observational program in patients whom betahistine dihydrochloride (betaserc®) tablets were prescribed in the usual manner at the maximal recommended daily dose of 48 mg in accordance with the locally approved label. over a program period physician is free to adjust betahistine dihydrochloride dose according to country approved label. adult outpatients with vestibular vertigo who can be treated with betahistine dihydrochloride as per the locally approved label will be enrolled in the program. the program consists of an observational treatment period (up to 2 months) and a follow-up period (up to 2 months, for evaluation of the course of vestibular vertigo after treatment completion).

Eligibility criteria:
inclusion criteria * male or female 18 years and older. * patients with vestibular vertigo of known or unknown origin, and for whom the physician has decided to prescribe 48 mg of betahistine dihydrochloride (betaserc®) in accordance with locally approved label. * patients who are willing and able to provide authorization to the investigator to use and/or disclose personal and/or health data. * patients who started betahistine dihydrochloride (betaserc®) therapy not more than 5 days priory to sign patient authorization (consent) for use/disclosure of data. exclusion criteria * patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion based on clinical judgment. * labeled contraindications of betahistine dihydrochloride (betaserc®) treatment. * patients with middle or inner ear infection. * patient with psychiatric disorders, significant neurological disorder or spinal cord damage. * patients receiving any other agents for peripheral vestibular vertigo such as diuretics, transtympanic gentamycin, cinnarizine, competitive antagonist of histamine, blocking h1- histamine receptors.

Keywords: meniere disease betahistine dihydrochloride vertigo
a study of peginterferon alfa-2a in combination with ribavirin in chronic hepatitis c (chc) patients with compensated liver cirrhosis (lc)

Conditions: Liver Cirrhosis; Chronic Hepatitis C

Summary: this study evaluated the clinical response of the efficacy and safety of the combination therapy of peginterferon alfa-2a and ribavirin, compared with an antiviral treatment-free group in chc patients with compensated lc. additionally, this study evaluated the dosage reactivity and the pharmacokinetic characteristics of the combination therapy of peginterferon alfa-2a and ribavirin in chc patients with compensated lc.


Eligibility criteria:
inclusion criteria: * patients aged 20 to 75 years-old with quantifiable serum hcv-rna (≥ 500 iu/ml), elevated serum alanine aminotransferase activity (≥ 45 iu per liter) within sixty days of screening, and proven chc with compensated lc (child-pugh a) on liver biopsy. exclusion criteria: * patients with neutropenia (fewer than 1,500 neutrophils per cubic millimeter) * thrombocytopenia (fewer than 75,000 platelets per cubic millimeter) * anemia (less than 12 g hemoglobin per deciliter ) * hepatitis b co-infection; decompensated liver disease. * organ transplant * creatinine clearance less than 50 milliliters per minute * poorly controlled psychiatric disease * poorly controlled diabetes * malignant neoplastic disease * severe cardiac or chronic pulmonary disease * immunologically mediated disease * retinopathy

Keywords: chc with compensated lc