Kornimate/medical-research-clean huggingface dataset:
phase 2 study of khk7580

Conditions: Secondary Hyperparathyroidism

Summary: this randomized, placebo-controlled, double-blind (included open arm of krn1493 (cinacalcet)), parallel-group, multi-center study is designed to evaluate efficacy and safety in cohorts comprising khk7580, its placebo and krn1493 (cinacalcet) orally administered for three weeks for secondary hyperparathyroidism patients receiving hemodialysis.


Eligibility criteria:
inclusion criteria: * subjects who have voluntarily consented to participate in this study * subjects with stable chronic renal disease receiving hemodialysis 3 times weekly for at least 12 weeks before screening * subjects with an intact parathyroid hormone of \>= 240 pg/ml at screening exclusion criteria: * subjects with primary hyperparathyroidism * subjects who have received cinacalcet hydrochloride within 2 weeks before screening * subjects whose dose or dosing regimen of an active vitamin d drug or its derivative, phosphate binders, or calcium preparation has been changed or started within 2 weeks before screening. * subjects who have underwent parathyroidectomy and/or parathyroid intervention within 24 weeks before screening. * subjects with uncontrolled hypertension and/or diabetes * subjects with severe heart disease. * subjects with severe hepatic dysfunction. * subjects who have received any other investigational drug within 12 weeks before screening * other subjects unfit for participation in this study in the judgment of the investigator or sub investigator.
mobile health app to promote participation of black women in breast cancer clinical trials

Conditions: Breast Cancer

Summary: this study explores the overall feasibility, impact, and satisfaction of using the "mhealth app" on clinic workflow for black or african american women diagnosed with breast cancer. the "mhealth app" which can be used as a platform to share clinical trial education and communication, was created and tested in previous steps of this study.

a patient advisory council (pac) was recruited from established hospital and community networks (north carolina cancer hospital's patient and family advisory board, and the lineberger community outreach and engagement office's community advisory board). the pac informed the content of interview guides, questionnaire/survey instruments, and mhealth app design, and will be involved in the analyses of qualitative and quantitative data, and dissemination of study results. after analysis of the in-depth interviews, the connected health for applications and interventions (chai) core staff developed a progressive web application "mhealth app". mhealth app was tested in a pilot study included 20 african american (aa) patients diagnosed with breast cancer were interviewed to answer questions that will better inform the clinical trial education and communication needs of black women with breast cancer. eighty african american women with newly diagnosed breast cancer who have access to a mobile device or computer will be recruited for the study intervention. women will receive access to the "mhealth" app, a list of available clinical trials within a 50-mile radius of their zip code, and the existing standard of care packet of cancer center resources. participants will complete a brief questionnaire that will assess clinical trial knowledge, how often a clinical trial discussion occurred during their oncology appointment, and if a therapeutic trial was offered.

Eligibility criteria:
inclusion criteria: * 18 years or older * english speaking * able and willing to participate to complete the survey. * have access to a mobile device or computer. * diagnosed with breast cancer. * identify as african american exclusion criteria: * inability to read and speak english. * dementia altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.

Keywords: application mhealth
medically assisted fertilization techniques in systemic immunoreumatologic diseases

Conditions: Rheumatic Diseases; Fertility Disorders; Pregnancy, High Risk; Pregnancy Complications; Immunologic Disease

Summary: systemic rheumatological diseases often occur in young women of childbearing age and can therefore impact fertility. there are diseases, such as arthritis, which present no contraindication to assisted reproductive techniques (arts), because there is no influence on the disease itself if the disease activity at conception is stable. on the other hand, patients suffering from connective tissue diseases, primarily systemic lupus erythematosus (sle) and patients suffering from primary or sle-related anti-phospholipid antibody syndrome (aps), deserve more targeted therapies both in the context of arts and in the ensuing pregnancy. to evaluate the response to arts in patients with systemic rheumatological diseases, both in terms of reactivation of the underlying pathology and in terms of arts outcome.

according to standard clinical practice related to medically assisted procreation treatments, for controlled ovarian stimulation aimed at oocyte recovery, patients underwent therapy with recombinant, biosimilar, or purified human gonadotropins and eventual suppression of spontaneous ovulation with gonadotropin-releasing hormone stimulating antagonist (gnrh-antagonist), and this information will therefore be recorded. the subsequent final induction of oocyte maturity can be by purified human chorionic gonadotropin (hcg), by gonadotropin-releasing hormone stimulating hormone analog (gnrha), or by the combination of the two, and this information will therefore also be recorded. similarly, therapies routinely administered for endometrial preparation and luteal support during embryo transfer procedures will also be recorded (transdermal estradiol, oral estradiol; transvaginal micronized progesterone; subcutaneous progesterone). with regard to the types of pma used, patients may have undergone homologous or heterologous procedures based on the patient's own choice and specialist indications. the ivf technique is an in vitro fertilization that consists of the union of the egg with the sperm in the laboratory -in vitro- for the purpose of obtaining already fertilized embryos to be transferred into the maternal uterus. the icsi technique consists of intracytoplasmic sperm injection and involves the insemination of an oocyte by micro-injection of a single sperm directly into it.

Eligibility criteria:
inclusion criteria: * patients diagnosed with systemic immunoreumatologic disease such as sle, aps, ra, spa, scls, ss, pm-dm, vasculitis * patients who have performed one or more pmas between january 2000 and april 2021 * patients who had their last follow-up by february 2022 exclusion criteria: * patients diagnosed with only one organ autoimmunity (e.g., diabetes mellitus i, thyroiditis of hashimoto's, celiac disease or chronic inflammatory bowel disease in the absence of systemic disease associated); * patients with severe renal failure, significant pulmonary hypertension or cardiomyopathy severe.
the divine study: dietary management of glucose variability in the icu

Conditions: Critically Ill Mechanically Ventilated Subjects

Summary: to compare the nutritional effect on blood glucose of two commercially available enteral diets in overweight or obese patients in the intensive care unit.


Eligibility criteria:
inclusion criteria: * new admit to the icu and expected to remain in icu 5 days * ventilator dependent up to 48 hours prior to admission to the study * requiring tube feeding enteral nutrition (en) 5 days * expected to receive 50% of caloric needs within 72 hours * body mass index 26-45 exclusion criteria: * trauma patients * major surgery in past 30 days or planned for next 7 days * diabetes mellitus (dm) type 1 * admitted with diagnosis of diabetic ketoacidosis as primary diagnosis * pregnant or lactating * non-functioning gi tract * use of parenteral nutrition in past 30 days * admitted with burns \> 20% body surface area * traumatic brain injury * hemodynamic instability that prevents delivery of en \> 24hr * unable to access gi tract for feeding via tube, unable to receive en * other contraindication to tube feeding * any other condition that would not allow patient to complete the study protocol * use of enteral formula at enrollment that cannot be changed to the investigational product
evaluation of somavac 100 sustained vacuum system

Conditions: Breast Cancer

Summary: the purpose of this research study is to compare the effectiveness of the somavac 100 sustained vacuum system versus manual section bulbs after immediate breast reconstruction.

participants will undergo a screening that includes medical history review. once screening is complete, participants will undergo immediate breast reconstruction per the surgeon's typical protocol. surgeon will place up to two (2) drain(s) per breast as customary without changing their technique at the end of the surgical procedure. somavac® 100 sustained vacuum system will be attached to the end of the drain(s) on one side of the subject and standard of care manual suction bulbs attached to the other side. subjects will return to the clinic every 72 hours for visits for the first 1 to 2 weeks, until the drain drops below 25ml, or as instructed by the physician. each visit will take about 30 minutes. subjects will have routine phone calls with the clinic to provide their drain output information to help determine when the drains should be removed. this is a study where the standard techniques of closed suction drainage are used for the removal of fluid from a surgical site. hence, an increased risk related to post-operative care is not anticipated.

Eligibility criteria:
inclusion criteria: * aged 21 years or older; undergoing immediate pre-pectoral breast reconstruction after mastectomy (bilateral) with tissue expanders or implant * capable of providing informed consent * willingness to follow all study requirements including agreeing to attend all required follow-up visits and signs the informed consent. exclusion criteria: * reconstruction is not post-mastectomy * pregnant or lactating females * patients needing more than 2 drains per breast * patients on steroids or other immune modulators known to impact healing * patients who are likely to not complete the study * patient who, in the opinion of the investigator, are unlikely to comply with the protocol * patients who have participated in this trial previously and who were withdrawn * patients with known allergies to contacting materials (i.e. latex, metal, etc.) * patients who received neoadjuvant chemotherapy or radiotherapy within the last 6 months * has any medical condition such as obesity (bmi\>40), uncontrolled diabetes (hba1c\>7%) and/or immunosuppression.
effect of foot insole on body alignment, and in stroke patients

Conditions: Stroke

Summary: goal: this study will be conducted to find out the effects of customized insole on foot alignment, body alignment, and balance ability of stroke patients. recruitment: total 20 participants will be recruited and will be divided into 2 groups: intervention and control group with or without wearing foot insole for 6 weeks. evaluation tool: 1. mediace scanner-ms320f will be used to evaluate foot alignment and will create customized insole. 2. exbody 770 will be used to measure body alignment. 3. timed up \& go test will be used to evaluate dynamic balance. intervention: the intervention group will wear a customized insole during daily life for 6 weeks whereas the control group will not. evaluation will be conducted 2 times before and after 6 weeks.

this study will recruit 20 stroke patients and will randomly assign them to the intervention group (n=10) and control group (n=10). after given the full description of the study, participants who will voluntarily agreed to participate will be included. this study involves producing customized insoles for participants to wear during daily activities for six weeks. the customized insoles will be produced using the mediace scanner-ms320f, which scans the participants' feet in a seated position. the participants in the intervention group will wear the produced insoles during daily activities. their rehabilitation program will be continued apart from the insole wearing. the participants in the control group will wear their normal insoles during daily activities. also, their rehabilitation program will be continues as same as the intervention group. outcome measure will be conducted twice, pre- and post-intervention. it includes foot alignments and arch height using the mediace scanner-ms320f, body alignments using the exbody 770, and balance ability using the timed up \& go test.

Eligibility criteria:
inclusion criteria: * chronic (more than 1 year ago) stroke patient over 50 years old * mmse (mini-mental state examination) score of 24 or higher out of 30, capable of understanding the experimenter's instructions * no history of orthopedic surgery * voluntarily agreed to participate exclusion criteria: * neurological problems other than stroke affecting balance ability * movement restrictions or involuntary limb movements due to ankle pain * severe visual impairment, field defects, cognitive impairment making it impossible to use evaluation equipment * taking medication affecting posture and balance ability

Keywords: stroke insole foot arch body alignment balance
study of monotherapy rapastinel in the prevention of relapse in patients with major depressive disorder (mdd)

Conditions: Depressive Disorder, Major

Summary: the study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) or 225 mg of rapastinel compared to placebo in the prevention of relapse in participants with major depressive disorder (mdd).


Eligibility criteria:
inclusion criteria: - * completion of study rap-md-30, rap-md-31, or rap-md-32 * if female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hcg) pregnancy test exclusion criteria: - * dsm-5-based diagnosis of any disorder other than mdd that was the primary focus of treatment within 6 months before visit 1 * lifetime history of meeting dsm-5 criteria for: * 1.schizophrenia spectrum or other psychotic disorder * 2.bipolar or related disorder * 3.major neurocognitive disorder * 4.neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study * 5.dissociative disorder * 6.posttraumatic stress disorder * 7.mdd with psychotic features * significant suicide risk, as judged by the investigator

Keywords: depression
moxifloxacin versus ofloxacin plus metronidazole in uncomplicated pelvic inflammatory disease: multicenter randomized controlled trials

Conditions: Pelvic Inflammatory Disease

Summary: we aimed to compare efficacy and safety of combination therapy with oral ofloxacin, 400 mg twice daily, plus oral metronidazole, 500 mg twice daily, for 14 days, with moxifloxacin monotherapy, 400 mg once daily, for 14 days


Eligibility criteria:
inclusion criteria: 1. women diagnosed uncomplicated pid 2. patients age are between 14 with 45 3. pelvic tenderness and vaginal discharge exclusion criteria: 1. urinary tract enfections 2. tubo-ovarian abscess and complicated pid 3. hıstory of antibiotics treatment 4. other pelvic pain causes 5. endometriosis 6. delivery,abortion and surgery within last months

Keywords: treatment, moksifloksasin
the effects of chin tuck against resistance exercise on acute stroke patients with dysphagia

Conditions: Acute Stroke; Dysphagia

Summary: the aim of this study is to investigate the effects of chin tuck against resistance exercise on swallowing function, depression, and quality of life in acute stroke patients with dysphagia.

the study is an experimental research design, with participants randomly assigned to either the experimental group or the control group. the experimental group will undergo chin tuck against resistance exercises, while the control group will receive traditional swallowing rehabilitation training. the subjects of this study are patients from the neurology and rehabilitation wards of a medical center in northern taiwan. the research tools include a personal basic information questionnaire, the standardized swallowing assessment, the functional oral intake scale, the patient health questionnaire-9, and the taiwan version of the swallowing quality of life questionnaire. data collection for both groups will be conducted using a pre-test and post-test method.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed with hemorrhagic or ischemic stroke, including those with initial diagnoses or recurrent strokes. 2. patients who did not pass the swallowing screening based on the standard swallowing scale. 3. adults aged 18 years and older. 4. vital signs are stable: systolic blood pressure (hemorrhagic \ 92%. 5. the patient's consciousness is clear, able to express themselves, can communicate in mandarin or taiwanese, and can follow commands to perform actions. 6. the patient can be in a seated position. exclusion criteria: 1. patients who have had a stroke for more than one month (inclusive). 2. patients with a history of depression or related mental health disorders. 3. patients with a history of neck pain, injury, or disease. 4. patients who have previously undergone tracheostomy or have a tracheostomy tube in place.
computer-assisted self-training to improve executive function

Conditions: Parkinson Disease; Stroke; Cardiac Arrest; Cognitive Dysfunction; Executive Dysfunction

Summary: this project explores the effects of specialized computer-based cognitive rehabilitation (cbcr) targeting executive functions in three groups of patients: stroke, cardiac arrest and parkinson's disease. the effect of specialized cbcr is compared to generally cognitively stimulating activities on a computer

this project explores the effects of specialized computer-based cognitive rehabilitation (cbcr) targeting executive functions in three groups of patients: stroke, cardiac arrest and parkinson's disease. the effect of specialized cbcr is compared to completing generally cognitively stimulating activities on a computer. a total of 307 patients is expected to be enrolled. all patients will complete a neuropsychological test battery assessing executive functions at inclusion, directly after the eight-week training period and at follow-up three months after the end of the intervention period. furthermore, all patients will answer questionnaires concerning quality of life and adl-measures at baseline, after the intervention and at follow-up. all patients will train for a period of 8 weeks, 5 times a week for 60 minutes regardless of their group allocation.

Eligibility criteria:
inclusion criteria: * a diagnose of stroke, cardiac arrest or parkinson's disease. * aged 18 years or older. * impaired working memory measured with cabpad working memory test, cut off for inclusion: 5 symbols or less backwards * computer and internet access at home. * providing informed consent. inclusion criteria specific for stroke * inclusion within 6 months post-stroke * stroke confirmed by clinical findings and imaging, both ais and ich is allowed. * initial stroke severity \>/= nihss 3. inclusion criteria specific for cardiac arrest • inclusion within 6 months post ictus. inclusion criteria specific for parkinson's disease * clinical diagnosis of pd. * anti-parkinsonian medical treatment (dopaminergic or other). exclusion criteria: * informed consent not provided * other neurological or psychiatric disease which is expected to influence the patient's ability to participate in the trial according to the investigator * not able to participate according to investigator exclusion criteria specific for stroke * patients with massive anosognosia for executive dysfunction or patients with no subjective feeling of executive dysfunction (patient sustains total denial of executive symptoms over time) * patients with severe aphasia, in which it is unclear whether the patient's performance on a neuropsychological test-battery is due to aphasia and not executive dysfunction. exclusion criteria specific for cardiac arrest • none exclusion criteria specific for pd • diagnosis of pd dementia according to the mds pd dementia criteria

Keywords: parkinson disease stroke cardiac arrest executive dysfunction cognitive dysfunction computer-based cognitive rehabilitation
safety and efficacy of drug-eluting beads trans-arterial chemoembolization for hepatocellular carcinoma in taiwan

Conditions: Hepatocellular Carcinoma Non-resectable; Chemoembolization, Therapeutic

Summary: to evaluate efficacy and safety profile of dc bead® tace in patients with hepatocellular carcinoma in taiwan.

to evaluate efficacy and safety profile of dc bead tace in patients with hepatocellular carcinoma in taiwan. this is a multi-center, retrospective, single arm study to explore safety and efficacy of dc bead tace in hepatocellular carcinoma (hcc) in taiwan retrospective analysis of medical records of all patients who underwent dc bead tace at national taiwan university hospital, national cheng kung university hospital, and taichung veterans general hospital from 2010-2017/7. all statistical data were analyzed with spss software (spss, ibm north america, new york, ny, usa). demographic and baseline lab data are presented by using descriptive statistics student's t-test. survival analysis will includes all patients.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of hcc, according to the aasld diagnosis criteria for hcc. * patient received dc bead tace. exclusion criteria: * patients with current any other cancer except non-melanomatous skin cancer. * infiltrative hcc * patients received ≥2 consecutive sessions of tace (≥2 tace at the same admission, no matter it is ctace or dc bead tace) * patients received dc bead tace and simultaneously received other therapy, such as radiotherapy, sorafenib etc. * presence of collateral vessel pathways potentially endangering normal territories during embolization. * presence of arteries supplying the lesion not large enough to accept dc bead® microspheres.
needle aspiration for large cephalohematoma

Conditions: Cephalohematoma

Summary: the cephalohematoma is a common pathology of newborns. observation is the primary treatment for the most of small uncomplicated cephalohematoma. however large cephalohematoma can lead to calcification with anesthetic local deformation or deformational plagiocephaly. the objective of the study was to evaluate the iatrogenic risk associated with early puncture on local anesthesia.

this is a retrospective study of 67 newborns followed at the university hospital of montpellier between 2010 and 2017. treatment was puncture under local anesthesia between 2 and 4 weeks of life. any potential complication events were searched retrospectively during the month after the puncture. analyze of the electronic medical record was made as followed: read of peri-operative and post-operative reports, looking for readmission in pediatric emergency department and finally read of the report of the clinical control 1 month after the procedure

Eligibility criteria:
inclusion criteria: * diagnosis of cephalohematoma was performed by the two senior plastic pediatric surgeon of the study * the diagnosis was confirmed by ultrasound examination exclusion criteria: * skull fracture (seen by ultrasound examination) * intra-cranial complication (ultrasound examination)

Keywords: cephalohematoma infant, newborn perinatal care plagiocephaly nonsynostotic skull/pathology