Kornimate/medical-research-clean huggingface dataset:
a chinese patent medicine yangzhengxiaoji capsule to improve the nausea of niraparib in the maintenance treatment in ovarian cancer

Conditions: Ovarian Cancer

Summary: this study is an open-label, single-arm， phase ii clinical trial of a chinese patent medicine yangzheng xiaoji capsule to improve the adverse reaction nausea of niraparib in the first-line maintenance treatment in advanced epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.

this study will investigate a chinese patent medicine yangzheng xiaoji capsule improve the adverse reaction nausea of niraparib in the first-line maintenance treatment in advanced eoc, who have previously received ≥ 3 cycles of prior combined bevacizumab chemotherapy and a complete or partial response with platinum-based chemotherapy. approximately 50 eligible subjects are planned to be enrolled, given yangzheng xiaoji capsule and niraparib maintenance treatment. the dosing regimen is:niraparib 200mg qd combined with yangzheng xiaoji capsule 0.36g\*4 tid，28 days/cycle. subjects will receive niraparib plus yangzheng xiaoji capsule up to 3 cycles.

Eligibility criteria:
inclusion criteria: 1. sign a written informed consent form before conducting any research-related procedures; 2. women aged 18 or above; 3. ovarian cancer, fallopian tube cancer or primary peritoneal cancer diagnosed histologically can be treated with niraparib after evaluation by clinicians; 4. life expectancy \> 3 months; 5. patients' ecog physical condition score is 0-1, kps score is ≥70; 6. patients received ≥ 3 cycles bevacizumab in combination within platinum-based chemotherapy 7. good organ function, including: * neutrophil count ≥ 1500/l * platelet ≥ 100,000/l * hemoglobin ≥10g/dl * serum creatinine ≤1.5 times the upper limit of normal value, or creatinine clearance ≥60ml/min (according to cockcroft-gault formula calculation) * total bilirubin ≤1.5 times the upper limit of normal value or direct bilirubin ≤1.0 times the upper limit of normal value * ast and alt ≤2.5 times the upper limit of normal value, and liver metastasis must be ≤5 times the upper limit of normal value. 7. no serious abnormalities of heart, brain, lung, liver and kidney function; 8. no serious mental illness; 9. ability to comply with the plan; 10. the toxic and side effects of any previous chemotherapy have recovered to ≤ctcae 1 grade or baseline level, except for sensory neuropathy or alopecia with stable symptoms ≤ctcae 2 grade. exclusion criteria: 1. people who are allergic to the ingredients in yangzhengxiaoji capsule 2. have undergone major surgery within 3 weeks before the start of the study, or have not recovered any surgical effects after surgery, or have received chemotherapy. 3. patients who are combined with other cancers; 4. patients with severe heart, liver, kidney and hematopoietic diseases; 5 patients with poor compliance cannot take drugs according to regulations.

Keywords: niraparib, ovarian cancer,nausea
the effect of hand massage on pain, anxiety, and comfort levels of intensive care patients

Conditions: Stroke

Summary: this study titled "evaluation of the effect of hand massage on patients' pain, anxiety and comfort levels" aims to determine the effect of hand massage on patients in intensive care units. our study is single-center and will continue until may 30, 2023. the study is designed to create an experimental and control group. your patient is in the control group of the study. during the application period of the study, patients in the control group will be provided with routine nursing care and no additional nursing intervention will be applied. patients in the intervention group of the study will be applied a total of 12 sessions of hand massage, 6 sessions per week (15 minutes each session).

the study sample consisted of patients who were receiving treatment at the neurology intensive care unit of sakarya university training and research hospital between april and may 2023, who met the inclusion criteria and agreed to participate in the study. the patients were divided into an intervention group (n=32) that received 15-minute hand massage and a control group (n=32) that received routine nursing care. the sociodemographic data form, visual pain scale (vas), general comfort scale-short form and spielberger state-trait anxiety inventory (stai) were used to collect data. inclusion criteria * being 18 years of age or older * agreeing to participate in the study and having written permission * not having any cognitive, sensory or mental disorders * being able to speak and communicate in turkish * being fully oriented to place, time and person * individuals to be included should not have conditions such as masses, loss of sensation, fractures or ingrown toenails in their hands exclusion criteria * patients who do not agree to participate in the study * patients who want to leave the study during the research process will not be included.

Eligibility criteria:
inclusion criteria: * individuals aged 18 years and over who agreed to participate in the study * whose written consent was obtained * who had no communication problems (hearing, vision, speech, and perception) were included in the study. exclusion criteria: * patients who did not agree to participate in the study, who had conditions such as mass in the hand area, sensory loss, previous surgical operation, allergy or skin disease, fracture, and ingrown nail, and who could not complete 12 sessions were excluded.

Keywords: hand massage pain anxiety comfort intensive care unit nursing
use of a smart-phone based medication adherence platform to improve outcomes in uncontrolled non-insulin dependent diabetes among veterans

Conditions: Diabetes; Diabete Type 2

Summary: the purpose of this study is to determine if a novel smartphone-based medication adherence platform accompanied by directed pharmacist intervention can improve a1c control and medication compliance in non-insulin dependent diabetics.

this study will employ a case-crossover design where patients will undergo both a standard of care arm as well as an intervention arm (see figure 1). half of the study participants will be randomized and enrolled in the standard of care arm for the initial 3 months and then transition to the intervention arm for 3 months. the remaining patients will be enrolled in the intervention arm for the initial 3 months and then transitioned to the standard of care arm. primary outcomes will be the change from pre-intervention baseline in hemoblobin a1c (hga1c) between the dayamed arthur platform and standard of care. secondary outcomes will include change in mas, the change in rma from week 1 of intervention arm to week 12, comparison of historical mpr and pdc with patient's rma at week 1 of intervention arm, and correlation of change in rma and mas score during intervention arm. furthermore, we will measure sustained change in mas in the patient population who begin study in the intervention arm and are subsequently transitioned to standard of care. we will also collect information patient usability/acceptability and provider satisfaction with the dayamed arthur platform. exploratory outcomes will include potential reduction in healthcare resource utilization based on avoidance of therapy escalation in patients with improved compliance, as well as psychosocial factors associated with improved adherence reduction of hgba1c by 0.5% from pre-intervention baseline for individuals on the dayamed intervention compared to standard of care

Eligibility criteria:
inclusion criteria: * assigned primary care provider at va sierra nevada healthcare system (vasnhcs) * diagnosis of type 2 diabetes * own a smart phone/tablet * hgba1c drawn at or within 30 days of study enrollment. * uncontrolled a1c defined as an a1c \>9 in the following order of preference * last 3 a1cs \>9% in the last 2 year * last 2 a1cs \>9% in the last 2 years * last a1c \>9% in the last 2 years * 2-year average a1c \>9% exclusion criteria: * actively on insulin therapy * unable to install dayamed application onto their phone/tablet * unable to load medications
prognostic relevance of biological subtype in breast cancer

Conditions: Breast Cancer

Summary: recently, the investigators face "on the edges" for treatment decision to decide adjuvant systemic treatment, especially for patients who show discordance between stage and tumor biology. the aim of this study was to compare the prognostic relevance of the tnm staging system and intrinsic subtype in breast cancer patients who received curative surgery.

identified patients who received curative surgery for stage i-iii breast cancer and had available data on immunohistochemistry profiles including hormone receptor status (hr) status, human epidermal growth factor receptor 2 (her2) status, and ki 67 staining at samsung medical center from january 2004 to september 2008. primary outcomes were recurrence-free survival (rfs) and overall survival (os).

Eligibility criteria:
inclusion criteria: * patients who received curative surgery * stage i-iii breast cancer * between january 2004 and september 2008 * had available immunohistochemistry profiles. exclusion criteria: * age \<18 years old * microinvasive carcinoma of breast
prevention of human papillomavirus (hpv) in 20 to 45 year old chinese women (v501-041)

Conditions: HPV Infections

Summary: a study to test the safety and effectiveness of quadrivalent hpv (types 6, 11, 16, 18) l1 vlp vaccine against combined incidence of hpv 6/11/16/18-related persistent infection and vaccine type-specific genital disease among chinese females between the ages of 20 and 45.

the base study v501-041 duration was 30 months. the study was extended to further evaluate the efficacy of quadrivalent hpv (type 6, 11, 16, 18) l1 vlp (qhpv) vaccine against cervical intraepithelial neoplasia grade 2 (cin 2), cin 3, adenocarcinoma in situ (ais), and/or cervical cancer. the efficacy was followed through the month 78 visit, and the close-out visit was conducted at approximately month 90 with only safety data collected

Eligibility criteria:
inclusion criteria: * healthy women between the ages of 20 and 45 * have used effective contraception for 2 weeks prior to starting in the study * does not have a temperature within 24 hours before the first injection exclusion criteria: * prior history of genital warts * more than 4 lifetime sexual partners * have undergone hysterectomy * have active cervical disease or history of cervical disease

Keywords: hpv 6/11/16/18 infection
application of hfnc for the prevention of hypoxemia during perioperative anesthetic-induced intubation in children: a randomized controlled clinical trial

Conditions: High-flow Nasal Cannula; Children; Pre-oxygenation

Summary: compared with adults, children have higher metabolic needs, and the airway is more likely to collapse. before tracheal intubation after anesthesia induction, the patient 's spontaneous breathing completely disappears. at this critical stage, the residual oxygen of the lung is consumed, resulting in hypoxemia and atelectasis. therefore, it is necessary to explore the best oxygenation strategy during intubation. in addition, ultrasound has become a common equipment in the operating room. it has the advantages of portability, repeatability, and no radiation, and can provide strong support for the diagnosis of gastric distension.

at present, hypoxia is still the main cause of complications and death during perioperative period. compared with adults, children have lower functional residual volume and lower tolerance to hypoxia caused by apnea due to their special physiological and functional characteristics. during anesthesia induction and tracheal intubation, spontaneous breathing completely disappears. at this critical stage, hypoxemia is prone to occur, which in turn causes various serious complications. mask ventilation may occur mask ventilation difficulties and flatulence ; since the introduction of nasal high-flow oxygen therapy ( hfnc ) into the operating room in 2015, its oxygenation method has been shown to be able to significantly improve blood oxygen when used alone in pre-oxygenation. when tracheal intubation is performed, hfnc can still maintain ventilation in the patient 's nose, so hfnc can combine the advantages of both masks to perform pre-oxygenation. there are few studies on the effect of hfnc on apnea oxygenation in children in the operating room.

Eligibility criteria:
inclusion criteria: * age 2-10 years old; * american society of anesthesiologists (asa) level i or ii; * children with healthy lungs and hearts; * clear headed and able to cooperate with anesthesiologists for treatment. exclusion criteria: * contraindications for hfnc: (1) complete obstruction of the upper respiratory tract; (2) skull base fracture or nasal bone fracture; (3) patients who refuse to use hfnc; * the american society of anesthesiologists (asa) rating is greater than level ii; * children with upper respiratory tract infections within 2 weeks; * pulmonary dysfunction, congenital heart disease in children;
addition of p1101 to imatinib treatment in patients with chronic phase chronic myeloid leukaemia not achieving a complete molecular response

Conditions: Chronic Phase Chronic Myeloid Leukemia

Summary: in this phase i pilot study, it is planned to investigate the feasibility and safety of adding an interferon therapy to an preexisting imatinib treatment in patients with chronic phase chronic myeloid leukaemia. the participating patients have already reached a response during their imatinib therapy (ccyr) but have still a detectable disease (no molecular response mr 4.5 or better).


Eligibility criteria:
inclusion criteria: * patients ≥ 18 years of age * bcr-abl positive chronic myeloid leukaemia in chronic phase treated with imatinib as first line therapy * chr, ccyr after at least 18 months of imatinib treatment * adequate organ function, defined as the following: * total bilirubin \< 1.5 x uln, * ast and alt \< 2.5 x uln, * creatinine \< 1.5 x uln, * anc \> 1.5 x 109/l, * platelets \> 100 x 109/l * written, voluntarily signed informed consent exclusion criteria: * cmr (molecular remission 4.5 or bcr-abl transcripts undetectable) * patient has received any other investigational treatment within 28 days before study entry * treatment with a second generation tyrosine kinase inhibitor (dasatinib, nilotinib) * ecog performance status ≥ 3 * patients with a primary of a different histological origin than the study indication (unless relapse-free interval is ≥ 5 years, except cervical carcinoma, basal cell epithelioma or squamous cell carcinoma of the skin) * evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease etc.) * acute chronic infections * known autoimmune disease (e.g. collagen disease, polyarthritis, immune thrombocytopenia, thyroiditis, psoriasis, lupus nephritis or any other autoimmune disorder) * female patients who are pregnant or breast-feeding * known diagnosis of hiv

Keywords: cml chronic myeloid leukemia chronic myeloid leukaemia peg-proline-interferon-alpha 2b interferon p1101 imatinib
a study to evaluate the safety and efficacy of ev06 ophthalmic solution in improving vision in subjects with presbyopia

Conditions: Presbyopia

Summary: the purpose of this study is to determine whether ev06 ophthalmic solution is safe and effective in improving distance corrected near vision in people who have presbyopia.

study subjects who were eligible for enrollment and had provided written informed consent were randomized in a 2:1 ratio to use of either ev06 ophthalmic solution or placebo ophthalmic solution. for the first 7 days of study product administration (period 1: days 1-7), subjects applied 1 drop of their assigned study product to one eye twice per day. for the next 84 days (period 2: days 8 - 91), if there were no unanticipated and no significant adverse events observed in the treated eye, subjects applied 1 drop of their assigned study product to both eyes twice per day.

Eligibility criteria:
inclusion criteria: * 45 to 55 years of age * distance corrected near visual acuity worse than 20/40 * best corrected distance visual acuity of 20/20 or better in each eye * willing and able to sign consent, following study instructions exclusion criteria: * certain pupillary conditions * significant astigmatism, glaucoma, diabetes, cataracts, eye surgery, ocular trauma or accommodative issues * contact lens wear within 3 days prior to and for duration of study * use of prohibited medications * participation in a clinical study within 30 days prior

Keywords: presbyopia vision unr844
measuring the glycemic index of pulse based breads

Conditions: Carbohydrate Intolerance

Summary: the objective of this study is to determine the glycemic index of 4 pulse-based breads in at least 10 normal healthy human volunteers. participants will be studied in the morning on 6 separate days after overnight fasts. on the first and last days they will consume a test meal consisting of about 2 slices of white bread (50g carbohydrate) and on the other 4 days they will consume 2-3 slices (50g carbohydrate) from 4 different test breads containing starch obtained from pulses (beans and/or lentils). blood glucose will be measured at intervals over 2 hours. glycemic index is calculated as 0.71 times f/wb where f is the incremental area under the curve of blood glucose (auc) after each test bread and wb is the mean auc after white bread.


Eligibility criteria:
inclusion criteria: * participants in good health exclusion criteria: * known history of hiv * known history of diabetes * history of hepatitis within the last 3 months * heart condition requiring hospitalization within 3 months * use of medications or presence of any condition which in the opinion of the study physician, would increase the risk of harm to the subject or to others, or affect the results of the study. * participants who cannot or will not comply with experimental procedures or the safety guidelines of glycemic index laboratories, inc.
prediction model for inadequate weight loss after sleeve gastrectomy

Conditions: Bariatric Surgery; Sleeve Gastrectomy; Weight Loss

Summary: this study aims to develop and validate a prediction model for estimating the probability of inadequate weight loss one year after sleeve gastrectomy.

inadequate weight loss (iwl) is a major problem after sleeve gastrectomy, leading to the recurrence of obesity-related comorbidities and increased risk of revision surgery. it is important to identify the high-risk individuals for iwl before surgery so that clinicians can initiate more rigorous weight monitoring and management strategies. therefore, this study aims to develop a prediction model using preoperative clinical and laboratory data to estimate the risk of iwl one year after sleeve gastrectomy, and then validate it using two separate datasets.

Eligibility criteria:
inclusion criteria: * bmi ≥ 27.5 kg/m2; * 16 years ≤ age ≤ 70 years; * complete preoperative data and one-year follow-up information exclusion criteria: * patients who did not undergo sg; * incomplete follow-up information; * patients with a history of pituitary or thyroid disease; * female patients who conceived within one year after surgery

Keywords: sleeve gastrectomy weight loss prediction model
comparison of two protocols to prevent the acquisition of methicillin-resistant staphylococcus aureus.

Conditions: Nosocomial Infections; MRSA Colonization

Summary: nosocomial infections is a major problem in intensive care units due to both growing incidence and pathogens implicated which become increasingly resistant to antibiotics. according to the center for disease control (usa), staphylococcus aureus is responsible for approximately 10% of cases. in europe, 79% of the s.aureus strains are resistant to methicillin, a routinely used antibiotic. recommendations for the prevention of transmission of these resistant bacteria are rarely based on controlled trials. therefore the aim of our study is to evaluate two protocols to prevent the acquisition of methicillin-resistant s. aureus in intensive care units: either a reinforced isolation precautions protocol or a standard precautions protocol.

recommendations for the prevention of transmission of resistant bacteria in intensive care units (icu) are rarely based on controlled trials. for this reason, we compared a reinforced isolation precautions protocol (ripp) with a standard precautions protocol (spp) for the acquisition of methicillin-resistant staphylococcus aureus (mrsa) in 2 intensive care units. evaluation: the risk for mrsa carriage was defined on admission if 1 of 3 criteria were met: hospitalization in the past year, transfer with prior length of stay ≥2 days, prior history of mrsa in the 5 past years. intervention: randomization 1/1 of a total of 500 patients to either protocol; mrsa screening was performed at the sites of carriage and colonization at inclusion, every week and at icu discharge in all patients; the results were given to the clinicians only for the patients of the ripp group. protocols: the spp was consistent with the cdc recommendations and included transmission-based isolation precautions to patients with clinical samples involving resistant bacteria (including mrsa) or highly transmissible organisms. the ripp included the extension of isolation precautions (1) to patients at risk for mrsa on admission until screening results proved negative and (2) to mrsa-positive patients on screening or clinical samples until further negative samples, in whom nasal mupirocin decontamination was added. compliance with the recommendations of each protocol was controlled by an audit. the efficacy is assessed on the proportion of patients who acquired mrsa at any site.

Eligibility criteria:
inclusion criteria: * adults over 18 years * expected length of stay \> 48h in intensive care unit * informed written consent exclusion criteria: * cerebral death * care limitation * neutropenia * documented mrsa on admission * patients receiving antistaphylococcal topical antibiotics on admission

Keywords: infection prevention isolation resistant bacteria mrsa colonization