Kornimate/medical-research-clean huggingface dataset:
a study of mrg002 in treatment of advanced her-2 positive breast cancer patients

Conditions: Breast Cancer With Liver Metastases

Summary: the objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of mrg002 in patients with her2 positive breast cancer with liver metastases.


Eligibility criteria:
inclusion criteria: 1. willing to sign the informed consent form and follow the requirements specified in the protocol. 2. aged 18 to 75 (including 18 and 75), both genders; life expectancy ≥ 12 weeks; 3. the score of ecog for performance status is 0 or 1 4. patients with her2-positive breast cancer confirmed by central laboratory and with evidence of liver metastasis by imaging; 5. archival or biopsy tumor specimens should be provided (primary or metastatic) for her2 testing; 6. patients must have measurable lesions according to the response criteria in solid tumors (recistv1.1); 7. organ functions must meet the basic requirements. 8. patients of childbearing potential are willing to take effective contraceptive measures from the time of signing the informed consent form to 6 months after last administration of the study drug. exclusion criteria: 1. previous history of other primary malignancies; 2. presence of peripheral neuropathy ≥ grade 2 (according to ctcae v5.0); 3. previously received antibody-drug conjugates, investigational drugs, anti-tumor vaccines or drugs, endocrine therapy for breast cancer, radiotherapy, cyp3a4 inhibitors or inducers, anthracyclines and other treatments; 4. central nervous system metastasis and/or neoplastic meningitis; 5. history of decompensated cirrhosis, or liver metastases with a single lesion ≥ 10 cm in longest diameter; 6. pleural or peritoneal effusion with combined clinical symptoms, which seriously endangers the life safety of subjects or urgently requires clinical treatment; or pericardial effusion with combined clinical symptoms; 7. any serious or uncontrolled systemic disease judged by the investigator; 8. uncontrolled cardiac disease; 9. evidence of active infection; 10. pulmonary embolism or deep venous thrombosis within 3 months prior to study treatment; 11. history of interstitial pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary dysfuction, symptomatic bronchospasm, etc.; 12. patients with active autoimmune disease or a history of autoimmune diseases who are receiving immunosuppressive agents or systemic hormone therapy, and are still using them within 2 weeks prior to enrollment; 13. history of hypersensitivity to any component of mrg002 or known history of hypersensitivity of ≥ grade 3 to trastuzumab injection; 14. uncontrolled tumor-related bone pain or urgent spinal cord compression; 15. other conditions inappropriate for participation in this study, as deemed by the investigator.

Keywords: mrg002 antibody drug conjugate (adc) her2
the influence of aerobic exercise on serum brain natriuretic peptide and c- reactive protein in cardiovascular disease

Conditions: Cardiovascular Disease

Summary: the purpose of this study was to investigate the effects of 8 weeks of aerobic exercise on serum concentrations of brain natriuretic peptide and c - reactive protein in patients with cardiovascular disease. patients were divided randomly into two groups: control and experimental aerobic group. this study was done with two - stage blood sampling: at the beginning and at the end of the treatment phase. all subjects were requested to avoid any exercise at least 48 hours before blood sampling. to study brain natriuretic peptide and c - reactive protein changes, 5 milliliters of blood were taken from patient's brachial vein. blood samples for subsequent measurements were frozen immediately and transported to the hormone laboratory for serum separation. the experimental group did the aerobic exercise programs for 8 weeks for 3 sessions per week and the control group did not receive any training. after completion of training, the final blood samplings were performed. exercise intensity according to the heart rate remained stable until the last week. brain natriuretic peptide and c - reactive protein levels were measured by elisa tests. all statistical analysis were done using spss software (version 16) and at the significance level of p≤ 0.05


Eligibility criteria:
inclusion criteria: * in this trial patients with coronary artery disease more than 70 percent at least in one coronary vessel with ejection fraction more than 40 percent in recent echo cardiograph without acute evidence of ischemia or congestive heart failure symptoms were selected and are divide randomly into two groups. exclusion criteria: * patients with acute evidence of ischemia or congestive heart failure symptoms are excluded.

Keywords: brain natriuretic peptide aerobic execise c- reactive protein
electrocoagulation vs. cold knife cutting in joint arthroplasty (electrocoagulation vs scalpel)

Conditions: Compassion

Summary: comparison of clinical outcomes of electrocoagulation and non-electrocoagulation techniques in total hip and knee arthroplasty surgery

objectives: a. to evaluate the effectiveness of electrocoagulation: * to measure the reduction in intraoperative bleeding volume when using electrocoagulation. * analyse the impact of electrocoagulation on surgical visibility and accuracy during implant placement. b. comparison of surgical outcomes: * investigate the incidence of intra- and postoperative complications, such as incidental vascular-nerve injury, wound infections, deep vein thrombosis, and implant-related problems, in patients operated on with electrocoagulation versus techniques without electrocoagulation. * examine the influence of haemostatic technique on the need for blood transfusion during or after surgery. * evaluation of long-term functional outcomes and patient satisfaction, including joint stability and range of motion, in both groups. c. review of patient recovery and period of hospitalization: * analysis of the impact of electrocoagulation on length of hospitalisation, and time to ambulation. * assessment of postoperative pain levels and analgesic medication use between the two groups. * patients' return to daily activities and overall quality of life after surgery. d. comparison of data obtained with other studies conducted internationally.

Eligibility criteria:
inclusion criteria: * patients who have given informed consent to the procedure * patients admitted over 18 years of age * patients with pathology requiring primary joint replacement (symptomatic gonarthrosis/coxarthrosis, avascular necrosis (avn) of the femoral head , femoral neck fractures, etc) exclusion criteria: * contraindications for major surgery or anaesthesia * patients with active infections that could interfere with outcome assessment * patients unable to give informed consent for psychological or cognitive reasons * severe medical conditions such as coagulopathies that may significantly influence outcomes * patients unable or unwilling to adhere to the required follow-up period * patients who died during the study period * patients with revision prosthesis operations

Keywords: electrocoagulation cold knife scalpel joint arthroplasty knee replacement hip replacement comparative analysis surgical techniques orthopedics outcome assessment
a survey of icatibant in pediatric participants with hereditary angioedema

Conditions: Hereditary Angioedema (HAE)

Summary: this study is a survey in japan of icatibant subcutaneous injection 30 mg syringe used to treat children or teenagers with acute attacks of hereditary angioedema (hae). the study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. the main aim of the study is to check for side effects related from icatibant subcutaneous injection 30 mg syringe and to check if icatibant subcutaneous injection 30 mg syringe improves acute attacks of hae. during the study, pediatric participants with hae will take icatibant subcutaneous injection 30mg syringe according to their clinic's standard practice. the study doctors will check for side effects from icatibant subcutaneous injection 30 mg syringe for 3 months.


Eligibility criteria:
inclusion criteria: - all participants with hae who are 2 to \<18 years of age, treated with icatibant subcutaneous injection 30 mg syringe for the first time. exclusion criteria: - participants who have been treated with icatibant subcutaneous injection 30 mg syringe in clinical trials or transfer cases, and so on.
developing trustworthy artificial intelligence (ai)-driven tools to predict vascular disease risk and progression

Conditions: Aneurysm Abdominal; Peripheral Arterial Disease

Summary: the vasculaid-retro study, within the broader vasculaid project, aims to create artificial intelligence (ai) algorithms that can predict cardiovascular events and the progression of abdominal aortic aneurysm (aaa) and peripheral arterial disease (pad). the study plans to gather and analyze data from at least 5000 aaa and 6000 pad patients, combining existing cohorts and retrospectively collected data. during this project, ai tools will be developed to perform automatic anatomical segmentation and analyses on multimodal imaging. ai prediction algorithms will be developed based on multisource data (imaging, medical history, -omics).

to date, it is unknown which abdominal aortic aneurysm (aaa) and peripheral arterial disease (pad) patients will suffer cardiovascular events or in which patients the aaa or pad will progress. in the vasculaid project, the vasculaid-retro study aims to leverage data from existing cohorts and retrospectively collected data to develop artificial intelligence (ai) algorithms able to evaluate the risk of cardiovascular events and extent of disease progression. in order to build and train the algorithms for the predictions, we plan to retrospectively enroll at least 5000 aaa and 6000 pad patients ai-tools will be applied to the patient data. automatic anatomical segmentation on images and image analysis on us, cta and mri will be performed. also, algorithms to predict cardiovascular events and aaa or pad progression based on multi-source data analysis will be developed. patient data from european clinical consortium partners is available. this consortium has access to big cohorts with relevant data for the envisioned study that will be used to enrich the existing registries. these data will be used to refine the algorithms developed for the prediction of cardiovascular events and aaa/pad progression.

Eligibility criteria:
inclusion criteria: * males and females, 40-90 years old, with an aaa \>3cm. this includes patients with infrarenal, juxtarenal, suprarenal, iliac (defined as 1.5x its normal diameter) aneurysms, as well as mycotic aneurysms. patients that have had interventions or ruptures will also be included * males and females, 40-90 years old, all pad patients (fontaine stages 1,2,3, and 4). exclusion criteria: * patients with an ascending, thoracic, thoracoabdominal (type 1-3) aneurysm.

Keywords: artificial intelligence, prediction models, image analysis, abdominal aortic aneurysms, peripheral arterial disease
the diep-flap as a model of ischemia-reperfusion

Conditions: Ischemia-Reperfusion

Summary: it is our goal to study the mechanism of ischemia-reperfusion injury. our diep-operation is actually a clinical model of ischemia-reperfusion. ischemia-reperfusion injury has never been directly studied in a human, clinical model of autologous transplant.


Eligibility criteria:
inclusion criteria: * patient is undergoing a diep-breast reconstruction, unilateral as well as bilateral * is aged 18 years or older exclusion criteria: * diabetes mellitus * diseases of the kidneys * diseases of the liver * patients who are taking immunosuppressants

Keywords: ischemia-reperfusion ischemia reperfusion diep-flap flap
a comparison of epidural techniques for labour analgesia

Conditions: Labour Analgesia

Summary: a trial comparing outcomes for different epidural techniques in labour analgesia

epidurals are the most common form of pain relief in labour. there are two techniques in use at the moment to place the epidural: epidural or combined spinal epidural (cse). cse has been shown to work faster and provide better pain relief than epidural alone. the investigators aim to show that cse also requires less medication over the course of labour as this may mean it has fewer side effects. the amount of medication needed during labour between the two different techniques given in a standardized way will be compared.

Eligibility criteria:
inclusion criteria: * healthy, singleton presentation at term exclusion criteria: * significant comorbidities likely to alter outcome of labour
a study to investigate how safe and effective solifenacin solution is in treating children/adolescents with symptoms of overactive bladder (oab) who completed study 905-cl-076

Conditions: Urinary Bladder, Overactive

Summary: this was a 40-week study to investigate how safe and effective solifenacin solution was in treating children or adolescents with symptoms of overactive bladder (oab), who completed study 905-cl-076 (nct01565707).

there was a titration period of up to 12 weeks during which the participants would be up or down-titrated based on a combination of efficacy and safety parameters followed by a fixed dose period during which no dose adjustments were allowed. participants completed a 7-day patient diary prior to every visit (start of 905-cl-076 to end of 905-cl-077, 14 visits). the first visit of this study (905-cl-077) was combined with the last visit of the 4-month study 905-cl-076. at each visit, the participant was required to undertake a number of assessments or examinations to determine whether it is safe for him/her to take part or to continue to take part in the study.

Eligibility criteria:
inclusion criteria: * subject has met the inclusion criteria of study 905-cl-076 and completed study 905-cl-076 exclusion criteria: * subject has failed the exclusion criteria of study 905-cl-076

Keywords: overactive bladder (oab) solifenacin succinate suspension phase 3 pediatric
bioequivalence study of torrent pharmaceutical ltd.'s montelukast sodium 10mg tablet under fed conditions

Conditions: Healthy

Summary: objective: primary objective of the present study was to compare the single dose bioavailability of torrent's montelukast sodium 10 mg tablet and innovator's(merck)singulair 10 mg tablet. dosing periods were separated by a washout period during fed study. study design: open-label, randomised, two period, two treatment, crossover, single-dose bioequivalence study


Eligibility criteria:
inclusion criteria: the volunteers were included in the study based on the following criteria: * sex: male. * age: 18 - 45 years. * volunteer with bmi of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight. * healthy and willing to participate in the study. * volunteer willing to adhere to the protocol requirements and to provide written informed consent. * non-smokers or smoker who smokes less than 10 cigarettes per day exclusion criteria: the volunteers were excluded from the study based on the following criteria: * clinically relevant abnormalities in the results of the laboratory screening evaluation. * clinically significant abnormal ecg or chest x-ray. * systolic blood pressure less than 100 mm hg or more than 140 mm hg and diastolic blood pressure less than 60 mm hg or more than 90 mm hg. * pulse rate less than 50/minute or more than 100/minute. * oral temperature less than 95°p or more than 98.6°p. * respiratory rate less than 12/minute or more than 20/minute * history of allergy to the test drug or any drug chemically similar to the drug under investigation. * history of alcohol or drug abuse * positive breath alcohol test * recent history of kidney or liver dysfunction. * history of consumption of prescribed medication since last 14 days or otc medication since last 07 days before beginning of the study. * volunteers suffering from any chronic illness such as arthritis, asthma etc. * history of heart failure. * hiv, hcv, hbsag positive volunteers. * opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, - - - cocaine positive volunteers based on urine test. * volunteers suffering from any psychiatric (acute or chronic) illness requiring medications. * administration of any study drug in the period 0 to 3 months before entry to the study. * history of significant blood loss due to any reason, including blood donation in the past 3 months. * history of pre-existing bleeding disorder. * existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers. * inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
study of sm-13496 (lurasidone hcl) in patients with schizophrenia

Conditions: Schizophrenia

Summary: the study evaluates the efficacy and safety of sm-13496 compared with placebo in patients with schizophrenia.


Eligibility criteria:
main inclusion criteria: * patient meets dsm-iv criteria for schizophrenia. * patient is 18 or older but younger than 75 years of age on the day of signing informed consent. * patient understands the objectives, nature, and other aspects of the study and voluntarily agrees to participate in the study by providing written informed consent. main exclusion criteria: * patient has a history of neuroleptic malignant syndrome, water intoxication, or paralytic ileus. * patient has parkinson's disease. * patient has a history or complication of malignancy.
a comparison of the perception of a needle injection pain between cancer patients receiving opioid therapy versus opioid-naive patients

Conditions: Cancer Patients

Summary: opioid-induced hyperalgesia (oih) is most broadly defined as a state of nociceptive sensitization caused by exposure to opioids. in humans, the evidence of oih is strong but conflicting. previous clinical studies mostly used experimental or non-standardized surgical stimuli to assess oih. we therefore sought to certify a presence of oih using a standardized, clinical pain stimuli in cancer patients receiving opioid therapy and opioid-naive patients.


Eligibility criteria:
inclusion criteria: * age 20-80 * cancer patient * patient whom receiving opioid treatment, any acute or chronic pain condition amenable to a diagnostic/therapeutic nerve block or neuromodulation,and a regular analgesic regimen. exclusion criteria: * patient who has any change in opioid or other analgesic medications less than 14 days prior to the scheduled procedure * an inability to understand english or adequately respond to the relevant questions

Keywords: opioid induced hyperalgesia
intraoral scanning v.s desktop scanning

Conditions: Edentulous Jaw

Summary: the aim of this study was to evaluate the effect of intraoral scanning versus desktop scanning on the retention and adaptation of maxillary denture bases in completely edentulous patients.

the use of intra oral scanners (ios) for rehabilitation of completely edentulous patients is still limited due to the difficulty in scanning large edentulous areas that are smooth and devoid of features. the stitching process can be defective, especially in the palatal area, where, the outmost deviations were reported in the palate when digitizing edentulous jaws with intraoral scanners. the main challenges for a fully digitized complete denture workflow are the digital impression of mobile tissues with functional border molding and the digital registration of the jaw relationship.

Eligibility criteria:
inclusion criteria: * patients with well-developed ridge * firm healthy mucosa * free from any signs of inflammation exclusion criteria: * patients having flabby ridge * decreased flow of saliva * limited mouth opening

Keywords: intraoral scanning cad/cam denture desktop scanning
clinical research study to evaluate the stain removal efficacy

Conditions: Tooth Stain Removal

Summary: the objective of this clinical research study is to evaluate the stain removal efficacy of a toothpaste containing stannous fluoride as compared to negative control toothpaste in adults.


Eligibility criteria:
inclusion criteria: * signed informed consent form * good general health * male and female subjects, aged 21-70, inclusive * present 12 scoreable natural anterior teeth * a minimum mean composite lobene index score of 1 or greater * available for the duration of the study * clinical evidence of a tendency to form extrinsic stain on anterior teeth exclusion criteria: * presence of orthodontic bands * presence of partial removable dentures * tumor(s) of the soft or hard tissues of the oral cavity * advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone) * five or more carious lesions requiring immediate restorative treatment * use of antibiotics or stain inducing medications any time during the one month prior to entry into the study * participation in any other clinical study or test panel within the one month prior to entry into the study * self-reported pregnancy and/or women who are breast feeding * dental prophylaxis received in the past four weeks prior to baseline examinations * history of allergies to oral care/personal care consumer products or their ingredients, including allergies to hydrogen peroxide * on any prescription medicines that might interfere with the study outcome * history of alcohol and/or drug abuse * exposed to a tooth whitening procedure during the last 3 months

Keywords: composite lobene extrinsic stain
hpv dna self-sampling in a general practitioner's office.

Conditions: Cervical Cancer; HPV Infection; Precancerous Lesion

Summary: one of the limitations of organized cervical screening in the czech republic is the lack of participation in preventive gynecological examinations. the aim of the project is to evaluate the benefits of self-sampling for hpv dna in general practitioners' outpatient clinics to improve population participation in cervical screening.

organized cervical screening in the czech republic has a long-term participation rate of about 56% of the target population. despite active invitations through health insurance companies, a part of the population is resistant and does not participate in screening visits to gynaecologists in the long term. a significant proportion of such women, however, regularly visit their general practitioner due to other comorbidities. the aim of the astra project is to assess whether an effective way to increase the proportion of women attending cervical screening is to perform self-testing for hpv dna in the gp's office.

Eligibility criteria:
inclusion criteria: * signed informed consent for statistical data processing and consent to the processing of personal data * age 30+ * hpv test never performed or performed more than 3 years ago or patient does not know exclusion criteria: * refusal to participate * pregnancy and puerperium * menses * history of hysterectomy * hpv test performed \<3 years ago with negative result * regular participation in screening and concurrent age 35, 45 or 55 years (test will be performed in the same year of screening).

Keywords: prevention cervical cancer hpv test self-sampling