Kornimate/medical-research-clean huggingface dataset:
thermal suit with forced-air warming in breast cancer surgery

Conditions: Hypothermia, Accidental

Summary: the aim of this clinical investigation is to prove that the thermal suit with forced-air warming is more effective to prevent inadvertent intraoperative hypothermia than conventional warming methods. the study group will have the thermal suit from arriving to the hospital until to the ward after surgery. in the operating theatre forced-air warming device will be connected to the trouser legs of the thermal suit and the device will be turned on during surgery. the control group will have normal hospital clothes. intraoperative warming will be managed with the warming mattress and a forced-air warming blanket. the primary endpoint is core temperature after arriving to the post-anaesthesia care unit.


Eligibility criteria:
inclusion criteria: * primary breast cancer surgery * unilateral resection or mastectomy with or without axillar lymphadenectomy * body mass index 25-40 exclusion criteria: * asa \> iii * decreased mental status * inadequate finnish language skills * other than general anaesthesia

Keywords: intraoperative hypothermia thermal suit forced-air warming
dose finding trial to assess the efficacy and safety of sotb07 in persistent asthma

Conditions: Asthma

Summary: this study is a dose finding trial to assess the efficacy and safety of sotb07 in persistent asthma.

a 12 week, multi-center, randomized, double blinded, parallel group, placebo-controlled, 4-arm, dose finding trial to assess the efficacy and safety of sotb07 in persistent asthma.

Eligibility criteria:
inclusion criteria: 1. male or eligible female subjects aged 15 years or more 2. a female is eligible if she is of: * non-child bearing potential (i.e., physiologically incapable of becoming pregnant), including any female who is at least 2 year after post- menopausal * child bearing potential and agrees to the acceptable contraceptive methods used consistently and correctly * negative pregnancy test at screening 3. non-smoker for at least 1 year, a pack history of ≤ 10 pack years 4. symptom of persistent asthma, as defined by the national institute of health (nih) 5. 50% ≤ fev1 ≤ 85% predicted at screening visit (withholding inhaled, short acting ß-agonist for 6 hours) 6. fev1 reversibility ≥ 12% and 200 ml at 20-30 minutes after inhalation of a short acting ß-agonist (salbutamol 2 puffs; 200㎍) at visit 1 or within 6 months before visit 1 7. capable of withholding salbutamol use for ≥ 6 hours prior to clinic visits 8. appropriately signed and dated informed consent has been obtained exclusion criteria: 1. active upper or lower respiratory tract infection within 3 weeks before visit 1 2. emergency room treatment for asthma within 1 month or hospitalization for asthma within 3 months before visit 1 3. any evidence of infectious, oncologic, or other active pulmonary disease obtained by chest radiography within 12 months before visit 1 4. clinically significant, in the opinion of the investigator, hematological, liver, renal, heart, neurological disease, or other serious disease 5. hypersensitivity to any β2-agonist, sympathomimetic drug, leukotriene receptor antagonist or sophora tonkinensis radix rhizoma 6. clinically significant and uncontrolled psychiatric disease or history of drug or alcohol abuse 7. inhaled, oral or parenteral corticosteroids within 4 weeks before visit 1 8. change of immunotherapy within 6 months before visit 1 9. administration of the antiasthma agent within 1 week of visit 1 10. administration of any other medication which may affect the course of asthma, or interact with sympathomimetic amines 11. participation in study using an experimental medication within 1 month before visit 1 12. other ineligible subject in the opinion of the investigator

Keywords: persistent asthma
alcohol brief intervention integrated with mobile chat-based support for risky drinkers in emergency departments

Conditions: Alcohol Misuse

Summary: this study aims to assess the effectiveness of chat-based intervention on reducing risky alcohol consumption to inform clinical practice for providing abi to risky drinkers attending aed in hong kong.

alcohol use is a major risk factor for non-communicable diseases and 6th leading cause of death and disability-adjusted life years. the prevalence of alcohol consumption has increased since 2008 after introduction of zero tax on alcohol with strength \<30% (e.g., wine and beer) and due to promoting the city as asia's wine hub. abi reduced alcohol intake by about 20g/week at 12-month follow-up in primary healthcare populations. given the relatively low prevalence of risky alcohol drinkers in hong kong, testing abi in clinics may face difficulties in recruitment. alcohol use is associated with problems such as injury and violence requiring accident and emergency department (aed) services, thus aeds in hong kong are more feasible places to recruit subjects for delivering abi. primary hypothesis: the intervention group has significantly larger reduction of weekly alcohol consumption compared with the control group at 12-month follow-up secondary hypotheses: compared with the control group, the intervention group has lower audit scores, fewer episodes of heavy/binge drinking, lower re-attendence at aed and reduced alcohol-related harms at 6-month and 12-month follow-up.

Eligibility criteria:
inclusion criteria: * hk resident able to read/communicate in cantonese/putonghua. this may exclude potential subjects from other countries with higher alcohol consumption than local chinese, but quality of the chat-based intervention is important for the research hypothesis, and it will not be feasible to recruit other language speakers (e.g., english) in the present study. * aged ≥18 with proficiency in using im apps (e.g., whatsapp, wechat). those aged \<18 are excluded as other studies suggest they have different patterns of alcohol drinking and reduction from adult drinkers. exclusion criteria: * those unable to understand or receive face-to-face abi due to severe traumatic injury, unconscious, or drunk patients unable to follow commands * anticipated to be admitted to in-patient department for \>1 week, which will interfere with the chat-based intervention * having psychiatric/psychological diseases or receiving regular psychotropic medication * participating in other alcohol reduction or abstinence programmes

Keywords: chat-based im alcohol brief intervention aed audit
adjuvant therapy with thalidomide after curative resection of hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma; Recurrence

Summary: postoperative recurrence of hepatocellular carcinoma (hcc) is a major problem after surgical resection. to date, adjuvant chemotherapy or other adjuvant modalities have not been proven effective in preventing or delaying recurrence. the aim of this prospective randomized study was to evaluate the effectiveness of thalidomide as a postoperative adjuvant regimen in inhibiting the recurrence of hcc

a number of modalities for preventing hcc recurrence after resection have been proposed and analyzed. both preoperative and adjuvant transcatheter arterial chemoembolization (tace) were found to be unable to reduce the risk of postoperative recurrence significantly, or confer a survival advantage. vitamin k (vk) is a fat-soluble vitamin that regulates clotting factor production by acting as a coenzyme for a vk dependent carboxylase that catalyzes carboxylation of glutamic acid residues into gamma-carboxyglutamic acid. the findings in vitro have indicated that vk2 has an antiproliferative effects against hepatoma cell lines, but its efficacy in suppressing hcc recurrence was not confirmed in human studies. interferon has a variety of biologic properties, including antiviral, immunomodulatory, antiproliferative, antiangiogenic and tumoricidal effects. it is reported that interferon is effective in preventing the development of hcc recurrence after its curative treatment in hcv-related cirrhosis. however, interferon treatment also has side-effects, including flu-like symptoms, fatigue, neutropenia, thrombocytopenia, depression, bone marrow suppression, and unmasking or exacerbation of autoimmune illnesses, which lead either to treatment disruption or dose modification. polyprenoic acid, an acyclic retinoid, reportedly is effective in prevention of second primary hepatomas, but long-term safety and efficacy data are lacking. thalidomide possesses immunomodulatory,anti-inflammatory, and antiangiogenic properties.it has successfully been applied for the treatment of various malignancies including hcc.to investigated whether postoperative adjuvant therapy with thalidomide could inhibite the recurrence of hcc after radical resection,we planed to conduct this clinical trial.

Eligibility criteria:
inclusion criteria: 1. 18-75 years old,male and female 2. patients who did not receive any anti-tumor therapies prior to the surgery (including liver transplantation, tace, local tumor ablation, chemotherapy, radiotherapy, molecular targeted therapy and other anti-tumor therapy) resection of hepatocellular carcinoma 3. patients who underwent radical resection of hcc, and 1 month after surgery,dynamic computed tomography showed on lesion in the liver and no signs of extrahepatic metastasis 4. sign the informed consent exclusion criteria: 1. women who were pregnant or breast-feeding 2. signs showing recurrence or metastasis one month after surgery 3. recurrent hcc 4. patients unable to take drug orally 5. patients inappropriate to participate in the trial upon the investigator's judgment
pilot study of multi-modality imaging in patients with hematologic malignancies

Conditions: Hematologic Malignancy

Summary: this is a pilot sub-study of patients receiving myeloablative transplant using total body irradiation (tbi) or total marrow irradiation (tmi) in their preparative regimen. the objective of this stub-study is to estimate the heterogeneity in cellular proliferation (flt-pet uptake) as well the heterogeneity in marrow composition distribution (measured using whole body water-fat mri) using positron emission tomography imaging. this will be used to design future trials as well as to determine the feasibility of pet and mri imaging.


Eligibility criteria:
inclusion criteria: * diagnosis of hematologic malignancy and fitting into one of the following categories: * newly diagnosed and/or day 14 post-induction chemotherapy * relapsed, including relapse after hematopoietic cell transplant * planned hematopoietic cell transplant (if enrolling at "close") or within 100 days post hematopoietic cell transplant (if enrolling post-transplant) with a preparative regimen that includes either total marrow irradiation (tmi) or total body irradiation (tbi) * undergoing natural killer cell therapies (with or without subsequent transplant) * aged 18 years and older * not pregnant - women of childbearing potential will have a confirmatory pregnancy test prior to each imaging per routine procedures * adequate renal function (estimated glomerular filtration rate \> 60 ml/min) as determined by a serum creatinine level performed as a part of standard of care within 7 days of imaging * able and willing to provide written consent exclusion criteria: * otherwise eligible patients meeting one or more of the contraindicates for an mri, may enroll in the study without undergoing the mri: * ferromagnetic implants * history of shrapnel or shot gun injury * too large to fit in the magnet (approximate body mass index ≥ 40) * cardiac pacemakers or other implanted devices that are not mr-compatible * claustrophobia * large tattoos

Keywords: leukemia lymphoma myeloma myelodysplastic syndrome
pharmacokinetics and pharmacodynamics (pk/pd) of cep-26401 in healthy subjects

Conditions: Cognitive Impairment

Summary: this is a single center, double-blind, placebo and positive-controlled, randomized, partial 6-way cross-over study to investigate the pharmacodynamics and pharmacokinetics of cep-26401 (5, 25, and 125 μg) following single-dose administration to healthy male and female subjects.


Eligibility criteria:
inclusion criteria: 1. the subject is able to give legal informed consent and understand the requirements of the study and communicate with the investigator in the local spoken language. 2. the subject is willing to comply with the study requirements (eg, all dietary, exercise, tobacco, and alcohol restrictions) and provide their written informed consent to participate in the study. 3. the subject is a man or woman, 18 to 50 years of age, inclusive. 4. the subject has a body mass index (bmi) of 18.0 to 30.0 kg/m2, inclusive. 5. the subject has skin type i to iv (very light to olive). 6. the subject is in a good health as determined by medical history, ecg, vital signs, physical examination, and clinical laboratory tests. 7. female subjects of childbearing potential must have a negative serum β-human chorionic gonadotropin (hcg) test (at screening) and check-in and be willing and able to use one of the protocol-specified double-barrier methods of birth control. 8. the subject is able to complete the screening process within 4 weeks prior to study drug administration. exclusion criteria: 1. the subject has a cognitive performance outside of reference values at screening. 2. the subject smokes, is a tobacco user, currently uses nicotine products. 3. the subject has a known hypersensitivity to donepezil, modafinil, irdabisant, or one of the excipients, or has any significant food or drug allergies. 4. the subject is a female who is pregnant or lactating. 5. the subject has an intraocular pressure greater than 22 mm hg. 6. the subject is suffering from, or has a clinically significant history of one or more of the following: cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s), or a history of any illness that, in the opinion of the investigator, might pose additional risk to the subject by participation in the study or confound the results of the study. 7. the subject has a laboratory abnormality judged by the investigator as clinically significant, or measurements outside of the defined range * other exclusion criteria apply; please contact the investigator for more information.

Keywords: irdabisant cognitive impairment
combined elastography and color doppler ultrasonography for breast screening with ultrasound

Conditions: Breast Cancer

Summary: the investigators hypothesis is that the combined use of elastography and color doppler ultrasonography can increase positive-predictive value of breast screening with ultrasound.

* asymptomatic women who undergo breast screening with ultrasound and has breast masses of breast imaging reporting and data system (bi-rads) category 3 or higher will be examined with conventional b-mode us as well as combined elasto-doppler us by breast radiologists. * the likelihood of malignancy and bi-rads category of the breast masses are assessed for each dataset of b-mode us alone and b-mode us with elasto-doppler us, respectively. * reference standard: biopsy or 1 year of follow-up examination. * the positive-predictive value, sensitivity, specificity, and diagnostic accuracy (assessed by the area under the receiver operating characteristic curve) are evaluated and compared between b-mode us alone and b-mode us with elasto-doppler us.

Eligibility criteria:
inclusion criteria: * women aged 30 years or older screened with breast ultrasound without specific symptoms * women who underwent mammography within 3 months which showed no abnormality except for dense breast * women who had at least one breast mass of bi-rads category 3 or higher. exclusion criteria: * women with breast implants * women who are unwilling or unable to provide informed consent * lesions larger than 3 cm * lesions that are previously noted and followed-up in the same hospital

Keywords: breast screening ultrasound elastography doppler ultrasonography
peers plus mhealth enhanced peer support

Conditions: Depression in Old Age

Summary: the goal of this intervention study is to design and learn whether peer support that is delivered through video chats and texting can decrease depression among older adults. participants will be assigned to a peer support program where they will receive 8 video chats with a peer mentor who provide social support and supportive texts over 8 weeks.

peers plus is a psychosocial intervention being developed to reduce depression among older adults. in this intervention peer mentors who are also 50 years of age and older and who have experiential knowledge of depression provide depression care. older adults with depression will be recruited and assigned to the peer support program. this will consist of 8 weekly peer mentor - older adult video chats that provide emotional support and sharing of self-care skills for depression. supportive texts will be sent on a weekly basis to older adults by peer mentors. these texts will provide encouragement, affirmations and information about mental health resources. peer mentors are trained and supervised by a mental health professional during the 8 week period. we will assess at baseline, post study and 3 months after the intervention.

Eligibility criteria:
inclusion criteria: 1. 50 years and older 2. phq-9 score \> 5, 3. on the same antidepressant dose for at least 3 months 4. if receiving psychotherapy, frequency is a most once a month 5. able to communicate in english 6. able to give informed consent. exclusion criteria: 1. meet diagnostic criteria for mania or hypomania 2. active suicidal ideation, 3) meet diagnostic criteria for psychotic syndrome 3. meet diagnostic criteria for substance abuse or dependence 4. a score on the mini mental state exam (mmse) \< 24.
single-dose nicotine pharmacokinetics with four oral nicotine replacement products

Conditions: Tobacco Dependence

Summary: single-dose nicotine pharmacokinetics with four oral nicotine replacement products. a study in healthy smokers.

forty-four (44) healthy male or female subjects will be included. single doses of an experimental nicotine medicated chewing gum 6 mg and nicorette® freshfruit gum 4 mg and 2 mg and niquitin™ mint lozenge 4 mg will be administered in a standardized mode, on four separate treatment visits. periods without nicotine replacement therapy, each lasting for at least 36 hours, will separate the treatment visits. the subjects will abstain from smoking from 8 pm the evening before each treatment visit and until the end of each visit. blood for pharmacokinetic analyses will be drawn before, and at 2, 4, 6, 8, 10, 15, 20, 30, 45, and 60 minutes as well as at 1.5, 2, 4, 6, 8, 10, and 12 hours after, product administration. subjects will be monitored to capture any adverse events that may occur.

Eligibility criteria:
inclusion criteria: * healthy subjects, smoking at least 15 cigarettes daily during at least one year preceding inclusion and bmi between 17.5 and 30.0 kilograms per square meter and a total body weight of at least 55.0 kilograms. * female participants of child-bearing potential are required to use a medically acceptable means of birth control. * a personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study. exclusion criteria: * pregnancy, lactation or intended pregnancy. * treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.

Keywords: smoking cessation, nicotine pharmacokinetics
randomized controlled single-blind trial to evaluate the mobile tracking of symptoms in ambulatory breast cancer patients

Conditions: Breast Cancer

Summary: health care has an increasingly demand for mobile applications (app), but studies are rare, which explore the added value and benefits for patient and physician. patients in different disease groups or physicians from different specialties are likely to have different demands. research should focus on selected groups to better understand their individual demands. our study intends to identify the added value of mobile symptom tracking in a selected subgroup of patients. we designed an app for breast cancer patients, who receive ambulant chemotherapy in a breast center. the patients track regularly their well-being and adverse events (ae) with the smartphone- or web-app and share it with the physician in the medical consultation. the data entry was designed to meet patient needs based on previous usability testing. the reporting of ae and well-being are standardized according to the definitions by ctcae 4.0 and ecog-index to ensure the reliability of patient self-reporting. the primary outcomes are the number of reported ae, the influence on their subjective well-being and the acceptance of context specific information. we will include 150 participants in this study. the calculated power is 91% respectively 80% for a 10 % improvement of well-being and a 2.2 increase of detected aes. the results will be compared to patients without app and to patients with app but without shared information. * trial with medical device


Eligibility criteria:
inclusion criteria: * female * 18 years old and older * german speaking * written informed consent * beginning of intravenous chemotherapy in the breast care center * diagnosis breast cancer * personal smartphone (own device) exclusion criteria: - patients who did not meet the inclusion criteria or if compliance could be questioned, e.g. due to a psychiatric illness or personal life.
glucose metabolism in sickle cell disease

Conditions: Sickle Cell Disease; Diabetes Mellitus

Summary: the purpose of the study is to better understand how the body handles sugars glucose and fats, such as cholesterol and triglycerides in sickle cell disease, and what puts certain persons at risk to develop diabetes. this understanding may help us to find new treatments to control blood sugar and prevent diabetes in people with and without sickle cell disease (scd). in this research, dna and rna will be isolated from blood cells. dna will be used to find genes that cause or protect from diabetes, high cholesterol and high triglyceride, and rna will be used for studies designed to find out how genes are doing their job of eventually producing proteins.

sickle cell disease (scd) is due to homozygosity for a glu6val mutation in hbb (sickle cell anemia; hemoglobin ss) or to compound heterozygous forms like hemoglobin sc disease and hemoglobin s-β thalassemia. past studies suggested a low prevalence of diabetes in patients with scd.10 improvements in treatment and care have increased the life span of patients. this, along with the wide availability of high calorie diets and increasing adiposity in scd raises that possibility that the prevalence of diabetes is increasing in scd. our study is designed to characterize the changes in metabolism that occur in sickle cell disease and to identify clinical, genetic and genomic risk factors for the development of diabetes. our hypothesis is that non-overweight subjects with scd have relative protection from diabetes and metabolic syndrome, but that those individuals who do become overweight have a dramatic increase in the rates of diabetes and metabolic syndrome. lean scd subjects will not have simply a neutral, but an overtly anti-diabetic phenotype (e.g. better glucose tolerance and lower metabolic syndrome markers). the two main study aims are as follows; aim 1. define the metabolic status of adult scd subjects according to normal or increased bmi. aim 2. determine genetic and genomic predictors of overweight, metabolic syndrome and diabetes in scd subjects.

Eligibility criteria:
inclusion criteria: * major sickling genotype (hemoglobin ss, sbeta0-thalassemia, soarab, sdpunjab) * age \>35 years * bmi \ 26 kg/m2 * steady state, defined as \>two weeks from a hospitalization for vaso-occlusive crisis, infection or surgery and not requiring immediate parenteral medication for pain control * fasting state (\>8 hours since ingesting food or medication for diabetes) exclusion criteria: * patients receiving insulin therapy * acute inflammatory or infectious illness or injury