Kornimate/medical-research-clean huggingface dataset:
detection of sleep apnea syndrome (osa) in pregnant women and assessment of impact of osa on pregnancy course

Conditions: Pregnancy; Sleep Apnea Syndrome; Obstructive Sleep Apnea

Summary: to assess prevalence of obstructive sleep apnea during pregnancy and its impact on prgnancy course and materno foetal wellbeing.

during pregnancy, obstructive sleep apnea (osa) prevalence is estimated between 5% and 15% and is associated with maternal and fetal comorbidities such as preeclampsia, neonatal intensive care admission , fetal growth retardation , preterm birth but even if growing, literature is still relatively poor about this topic. to date, there is no systematic screening of osa performed in at-risk pregnant women (obesity, hypertension, diabetes, fetal growth retardation, suggestive symptoms), probably mainly because of polysomnography complexity and accessibility. as in non pregnant woman, osa must be treated adequately during pregnancy. continuous positive airway pressure (cpap) is the reference treatment for severe osa. this device, by blowing air under pressure in upper airways, via a nasal of an oro-nasal mask, is able to alleviate the upper airway collapse responsible for the occurrence of obstructive sleep apnea. it has been proven to offer a survival benefit in patients with severe disease and to improve sleep quality, cardiovascular variables and health-related quality of life . cpap have been shown to improve fetal well-being in pre-eclampsia . oral appliance can be an alternative for mild to moderate disease and in patients who do not tolerate cpap. positional counselling can be sufficient in case of mild to moderate positional osa. associated behavioural strategies (diet and exercise) are always recommended in case of excessive weight. surgical treatments are dedicated to patients with specific anatomic problems but cannot be performed during pregancy. aim of the study: the primary aim of this study is to screen osa in at risk pregnant women with watch-pat 200, a simplified sleep study tool used on ambulatory mode and able to detect accurately osa in suspected patients. as secondary aim, we will observe the impact of osa on a composite endpoint assessing materno-fetal wellbeing.

Eligibility criteria:
inclusion criteria: * pregnant women * 12-15weeks of pregnancy * obese (body mass index\>30) exclusion criteria: * known sleep apnea syndrome * mental illness, deficiency

Keywords: pregnancy obstructive sleep apnea
medication-overuse headache: the effect of a patient educational programme as an add-on to standard treatment

Conditions: Secondary Headache Disorders; Medication-overuse Headache

Summary: the aim of this study is to evaluate the influence of personality profiles in patients with moh and to evaluate the effect of a custom-made educational programme as an add-on to standard treatment as compared to standard treatment alone in moh patients using a randomized controlled trial (rct) design.

worldwide, two percent of the population suffers from medication-overuse headache (moh), a paradox condition where the headache is caused by overuse of headache medication. common treatment is withdrawal, but there is no consensus on what constitutes the best treatment. the study consists of a rct with moh patients randomized to standard treatment versus standard treatment + a 12-week, 6-session educational programme as add-on. the programme is based on theory of motivational interviewing, and patients can choose between individualized education or education in groups. primary endpoint: headache frequency measured by self-reported headache diary on number of days with headache pre-vious month. secondary endpoints: neo-ffi-3 personality test, coping strategies, pain intensity, bothersomeness, patient satis-faction and reported medication intake.

Eligibility criteria:
inclusion criteria: * diagnosed with medication-overuse headache (moh) by neurologist (the international classification of headache disorders). * completed withdrawal (hospitalized of 8 days or at home). * age 18-65 years * understand and speak danish exclusion criteria: * comorbidity (e.g. whiplash, rheumatism which needs analgesic treatment * mental health disorders

Keywords: medication-overuse headache educational programme personality profiles
arsenic trioxide in treating patients with multiple myeloma

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

Summary: rationale: drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of arsenic trioxide in treating patients who have relapsed or refractory stage ii or stage iii multiple myeloma.

objectives: i. determine the response rate of patients with relapsed or refractory stage ii or iii multiple myeloma treated with arsenic trioxide. ii. determine the overall and relapse-free survival rates of patients treated with this drug. iii. determine the safety profile of this drug in these patients. outline: patients receive arsenic trioxide iv on days 1-5 and 8-12. treatment repeats every 4 weeks for up to 6 courses. patients are followed at 4 weeks after the last treatment dose. projected accrual: a total of 55 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: diagnosis of multiple myeloma stage ii or iii (durie-salmon) relapsed or refractory to conventional therapy no monoclonal gammopathy or indolent or smoldering myeloma measurable disease by serum and urine m protein and/or plasmacytoma patient characteristics: age: over 18 performance status: karnofsky 70-100% life expectancy: 3 months hematopoietic: granulocyte count greater than 1,200/mm3 platelet count greater than 100,000/mm3 hemoglobin greater than 10 g/dl hepatic: bilirubin less than 2 times upper limit of normal (uln) sgot/sgpt less than 2 times uln renal: creatinine no greater than 2.5 mg/dl cardiovascular: absolute qt interval less than 460 msec in the presence of normal potassium and magnesium levels prior concurrent therapy: biologic therapy: at least 28 days since prior biologic therapy chemotherapy: no more than 3 prior chemotherapy regimens, including no more than 2 cytotoxic regimens and 1 high-dose cytotoxic regimen as part of stem cell transplantation endocrine therapy: at least 28 days since prior endocrine therapy radiotherapy: at least 28 days since prior radiotherapy (except for focal radiotherapy for symptom control) surgery: not specified

Keywords: refractory multiple myeloma stage ii multiple myeloma stage iii multiple myeloma
the impact of coagulation disorders on the diagnosis and prognosis of sepsis

Conditions: Sepsis; Coagulation Disorder

Summary: the study was a retrospective, single-center clinical study. from all patients admitted to the emergency icu during the period of 2013.1.1-2019.12.31, the investigators screened all patients who met the criteria of 1) ≤7 days from symptom onset to enrollment; 2) patients who also met the criteria of the presence of clinical infections and sequential organ failure assessment (sofa) score ≥2; and 3) met the exclusion criteria, and retrospectively collected coagulation indices of the patients before anticoagulation with or without the use of heparin or low molecular heparin, and recorded the worst values of coagulation function of patients before heparin were recorded, and the organ function, inflammatory response, immune indexes, and conversion rate of severe disease were observed, so as to investigate the role of conventional coagulation indexes (fdp, d-dimer) and thromboelastography in the early diagnosis of septicemia patients and to indicate the prognosis.


Eligibility criteria:
inclusion criteria: * time from clinical symptoms to admission ≤ 7 days； * infection was diagnosed by clinician * systemic inflammatory response syndrome，systemic inflammatory response syndrome was defined as the presence of 2 or more of the following: (1) temperature \ 38℃, (2) heart rate \>90 beats per minute, (3) respiratory rate \>20 breaths per minute or paco2 \< 32 mm hg, or (4) white blood cell count ≥12 000 cells/mm3 or≤4000 cells/mm exclusion criteria: * pregnancy and lactation * have hematological diseases (including acute and chronic leukemia, hemolytic anemia, hemophilia, aplastic anemia, bone marrow fibrosis, congenital or acquired coagulation factor deficiency, etc.) * anticoagulant or antiplatelet drug treatment * 24 hours after severe trauma or surgery * autoimmune diseases * cirrhosis * malignant tumor patients with personal history or undergoing radiotherapy, chemotherapy and targeted treatment

Keywords: sepsis coagulation disorders
radiomics of intra-abdominal and subcutaneous adipose tissue predict the efficacy of bariatric surgery (risabs)

Conditions: Obesity; Type 2 Diabetes Mellitus; Bariatric Surgery

Summary: using radiomics of intra-abdominal and subcutaneous adipose tissue and clinical features to predict the weight loss efficacy and remission of type 2 diabetes mellitus after bariatric surgery.

in this study, the investigator intend to collect abdominal ct from patients who are proposed to undergo bariatric surgery, to extract the radiomics of intra-abdominal fat and subcutaneous fat, and to establish a prediction model for predicting the efficacy of weight loss and remission of type 2 diabetes mellitus at 1 year, 3 years, and 5 years postoperatively, in conjunction with the clinical data.

Eligibility criteria:
inclusion criteria: * bmi\>27.5kg/m2; type 2 diabetes mellitus; patients who will undergo bariatric surgery exclusion criteria: * patients without abdominal ct scan; patients did not undergo sleeve gastrectomy or roux-en-y gastric bypass.

Keywords: obesity type 2 diabetes mellitus radiomics abdominal adipose subcutaneous adipose prediction model
rollover study of lapatinib in cancer patients

Conditions: Neoplasms, Breast

Summary: the egf19060 study is a rollover study to evaluate the long term safety of lapatinib and to provide lapatinib to patients who had a positive response in previous lapatinib studies until lapatinib is available pending fda approval.


Eligibility criteria:
inclusion criteria: * currently receiving clinical benefit as defined by cr, pr or sd from treatment with lapatinib through participation in a phase i study of lapatinib either as monotherapy or as part of a combination regimen. * ability to understand and provide written informed consent to participate in this trial. * is male or female. * female and male subjects agree to the protocol specific birth control measures exclusion criteria: * permanent discontinuation of lapatinib in the previous study due to intolerance or treatment failure. * is a pregnant or lactating female. * is considered medically unfit for the study by the investigator as a result of the medical interview, physical exam, or screening investigations. * currently receiving treatment with any medications listed on the prohibited medication list (see section 7.2). * has class iii or iv heart failure as defined by the new york heart association (nyha) functional classification system. * has a left ventricular ejection fraction (lvef) \< 40% based on muga or echo.

Keywords: safety tolerating lapatinib lapatinib
the role of peptide yy (pyy)in inhibiting food intake.

Conditions: Obesity

Summary: 12 obese subjects will receive peripheral administration of placebo and 4 escalating doses of pyy1-36 and another 12 obese subjects will receive peripheral administration of placebo and 4 escalating doses pyy3-36 on 5 different test days within one week. the patients will be tested in a single blinded dose escalating protocol. measurements of appetite, ad libitum energy intake, blood pressure and blood sampling will be performed during the test day.


Eligibility criteria:
inclusion criteria: * normal weight (bmi: 18-23 kg/m2) or 12 overweight/obese (bmi: 27-40 kg/m2) * body weight fluctuations \< 5 kg over the past 2 months. * blood pressure normal to mildly hypertensive(\<159/99 mm hg) * non-elite athletes and not planning to change physical activity during the study. exclusion criteria: * any physiological or psychological illnesses that could influence the study results. * regular use of medicine. * smoking defined as \<1 cigarette per day. * substance abuse or dependence. * blood donation within the past 3 months before entering the study. * drinking \>21 alcoholic units/week. * food allergies. * special diets (e.g. vegetarian) or dislikes to any of the foods served during the study.
trial comparing outcomes with merocel packing or thrombin-jmi for anterior epistaxis

Conditions: Epistaxis

Summary: epistaxis is a common problem among people of all ages and backgrounds. however, occasionally epistaxis can be severe enough to require emergency room admission. among the treatment options for epistaxis, nasal packing is the most common approach. this approach requires a return visit to the clinic for removal of the packing. additionally, there is a great deal of pain during the insertion and removal of this packing. this study aims to justify the further investigation of thrombin as a potential treatment approach for these patients. thrombin could provide a treatment approach that reduces pain and eliminates the need for a return visit to the clinic.


Eligibility criteria:
inclusion criteria: * english speaking adults that have failed first line therapy for anterior epistaxis in the er or the hospital exclusion criteria: * non-english speaking patients * patients with bleeding disorders * known pregnant women or women that think they may be pregnant * patients with a know presence of antibodies to bovine thrombin preparations * patients that currently have or are known to have a history of systemic skin condition or rash such as eczema or psoriasis * patients found to have posterior epistaxis * patients requiring a surrogate for medical decisions

Keywords: epistaxis
a study of mk0777 gel extrusion module (gem) in the treatment of outpatients with generalized anxiety disorder (0777-019)

Conditions: Generalized Anxiety Disorder

Summary: the study will look at the effectiveness of mk0777 in patients with generalized anxiety disorder.


Eligibility criteria:
inclusion criteria: * male or female * current diagnosis of generalized anxiety disorder * age 18 - 70 exclusion criteria: * women who are pregnant, or breast-feeding * use of illicit drugs * history of drug or alcohol dependence
inflammatory markers and resistant depression

Conditions: Depression

Summary: this study focuses on blood inflammatory markers (pro-inflammatory cytokines, anti-inflammatory cytokines, monocytes costimulation molecules) in patients with resistant unipolar depression in comparison with non-resistant unipolar depressed patients.


Eligibility criteria:
inclusion criteria: * group 1: patients with resistant mdd (at least 2 failed treatments for the current episode) ,current treatment with irs or irsna, * group 2: patients with mdd remission after response to an antidepressant treatment. exclusion criteria: * comorbid somatic or psychiatric disorders: chronic or acute inflammatory diseases, previous treatment with brain stimulation for the current episode, legal protection

Keywords: resistant depression inflammation
the efficacy of melatonin in the burning mouth syndrome

Conditions: Sleep Disorders, Circadian Rhythm

Summary: burning mouth ( bms) syndrome is the oral disorder characterized by an intraoral burning sensation for which no medical or dental cause can be found. the headache classification committee of the international headache society (ihs) defines (bms) as an ''intraoral burning or dysaesthetic sensation, recurring daily for more than 2 hours per day over more than 3 months, without clinically evident causative lesions''. (bms) is a common, chronic problem that has a negative impact on quality of life. a wide variety of medications have been proposed for treating (bms) both topical and systemic. unfortunately, no treatment seems to offer assured results. melatonin is a naturally occurring hormone secreted by the pineal gland. it has soporific effects with oral administration and is well tolerated. it enhances sleep melatonin also may help sleep disturbances associated with (bms) ; however, this remains to be proven.

the purpose of this study is to establish whether melatonin can aid in reducing pain improve sleep quality in (bms)

Eligibility criteria:
inclusion criteria: * intraoral burning or dysaesthetic sensation, recurring daily for more than 2 hours per day over more than 3 months, without clinically evident causative lesions exclusion criteria: * previous or current therapy with melatonin * allergy or hypersensitivity to melatonin * less than 18 years old. * pregnant

Keywords: burning mouth syndrome, melatonin pain sleep
renal denervation in patients with uncontrolled hypertension (symplicity htn-2)

Conditions: Uncontrolled Hypertension

Summary: an international, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation in patients with uncontrolled hypertension.


Eligibility criteria:
inclusion criteria: * systolic blood pressure \>=160mmhg (\>=150 mmhg for type 2 diabetics); * on 3 or more antihypertensive medications * \>= 18 and =\< 85 years of age. exclusion criteria: * renal artery abnormalities * egfr \< 45ml/min * mi, angina, cva within 6 months * type 1 diabetes * icd or pacemaker, or any other metallic implant not compatible with mri * others

Keywords: hypertension renal denervation sympathetic nervous system rdn
lu-177 psma treatment in cell renal carcinoma

Conditions: Metastatic Renal Cancer

Summary: summary renal cell carcinoma (rcc) consists of 2% of all malignencies. rccs are generally divided to histopathological subtypes as clear cell and non-clear cell variants. clear cell variant responsible for the 75-80% of all rccs. it is reported that 20-30% of rccs are metastatic at the diagnosis and 5 years survival is approximately is 10-20% in this group of patients. moreover, 60% of patients who are not metastatic at the diagnosis, develop metastates within 2-3 years. 2nd and 3th line effective treatment option in metastatic rccs patients has been a subject of interest. psma (protatate specific membrane antigen) with the other name glutamate carboxypeptidase, is a transmembrane protein and overexpresses in prostate adenocarcinomas and neoangiogenesis spots of endothelium of other several tumor types. it infronts as a target for theranostic consept for mainly prostate cancer in nuclear medicine. as a radionuclide treatment option, lu-177 psma treatment is proved as safe and effective treatment option in castration resistant prostata cancer patients. after its widely use in prostate cancer, it is reported that psma molecule can be used for imaging of rcc patients and psma uptake is higher than 18f-fdg. for this reason, lu-177 psma treatment can be a systemic treatment option in rcc patients who have progress afer 1st cycle treatment. in this study we aimed to safety and efficacy of lu-177 psma treatment in metastatic rcc patients as systemic radionuclide treatment option.


Eligibility criteria:
inclusion criteria: * age \>18 * progression after at least 2 lines of systemic therapy or existence of a contraindication to systemic therapies * at least 3 years of life expectancy * ecog performance status ≤ 2 * ability to sign informed consent exclusion criteria: * age\<18 * not having received any systemic therapies * history of a secondary malignancy * ecog performance status \> 2 * any contraindication for radionuclide therapy (pregnancy, lactation, organ disfunction, metastatic lesions with a risk of compression * previous history of any radionuclide therapies * inability to sign informed consent

Keywords: renal cell carcinoma, radionuclide treatment, efficacy, safety.
clear care® plus for presbyopic contact lens wearers

Conditions: Presbyopia

Summary: the purpose of this study is to evaluate clear care® plus (ccp) compared to non-hydraglyde® multi-purpose contact lens solutions in presbyopes currently wearing soft contact lenses and experiencing symptoms of dryness.


Eligibility criteria:
inclusion criteria: * must sign an informed consent document; * current adapted two-week/monthly replacement soft contact lens wearers (at least 2 months) with symptoms of contact lens induced dryness; * near spectacle add of +0.50 or greater; * best corrected visual acuity (bcva) to 20/30 or better in each eye at distance; * willing to wear lenses for a minimum of 5 days per week, 6 hours per day, and attend all study visits; * currently (at least 2 months) using a non-hydraglyde® containing multi-purpose solution (opti-free® puremoist® is excluded) to care for lenses; * use of digital devices (eg, smart phone, tablet, laptop computer, or desktop computer) for 20 consecutive minutes at least twice a week and willing to continue the same pattern for the duration of the study; * other protocol-specific inclusion criteria may apply. exclusion criteria: * extended wear contact lens wearer (sleeps in lenses 1 or more nights per week); * any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear as determined by the investigator; * any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator, including use of any topical ocular medications that would require instillation during contact lens wear; * monocular (only 1 eye with functional vision) or fit with only 1 lens; * known sensitivity to any ingredients in clear care® plus (ccp); * prior refractive surgery; * history of herpetic keratitis, ocular surgery, or irregular cornea; * pathological dry eye that precludes contact lens wear; * use of mechanical eyelid therapy or eyelid scrubs within 14 days before visit 1 and not willing to discontinue during the study; * participation in any clinical study within 30 days of visit 1; * currently using or have not discontinued restasis®, xiidra® or a topical steroid within the past 7 days; * other protocol-specific exclusion criteria may apply.

Keywords: contact lens induced dryness
effects of massage on post-operative pain in urologic patients

Conditions: Postoperative Pain; Anxiety

Summary: the purpose of this study is to determine the effect that receiving massage therapy post-operatively has on reducing perceived anxiety and pain in urology patients. secondarily, the result of massage on patient satisfaction, length of hospital stay, and narcotic use will also be studied.

post-operative pain for urology patients can be an anxiety-provoking and distressing recovery process. massage therapy for post-operative pain has been shown to reduce pain and anxiety levels in various surgical patients however no study has assessed massage therapy effect on post-operative pain in patients who have gone through urological procedures. this study will investigate the effects of hand massage interventions during the post-operative period of urology patients. perception of pain and anxiety levels will be assessed, as well as vital signs before and after massage therapy will be measured. these findings may lead to both subjective and objective improvements in patients undergoing urological surgeries and procedures.

Eligibility criteria:
inclusion criteria: * urology patients over the age of 18 years old who are post-operative day 1 to post-operative day 4. exclusion criteria: * given pain medication in the past hour