Kornimate/medical-research-clean huggingface dataset:
effects of negative pressure ventilation on right ventricular function in cardiological patients

Conditions: Negative Pressure Ventilation; Right Ventricular Dysfunction; Right Ventricular Failure

Summary: patients receives induction of general anesthesia for interventional tricuspidal clipping and standard monitoring for this procedure including arterial and central venous line and transesophageal ultrasound. a cuirass for extrathoracal negative pressure ventilation is placed onto the chest but not switched on. during usual positive pressure ventilation a ventilatory, a hemodynamic and a 3d full volume ultrasounddataset of the right and left ventricle is recorded and severity of tricuspidal regurgitation examined. afterwards negative pressure ventilation is started and positive pressure ventilation reduced as far as possible without reduction of tidal volumes. the same dataset of ventilation, hemodynamics and ultrasound is collected again during negative pressure ventilation. afterwards the cuirass gets removed, study finished and everything proceeds as during standard procedure.


Eligibility criteria:
inclusion criteria: * patients planned for tricuspidal clipping exclusion criteria: * ventilatory of hemodynamic instability * fitting of cuirass not possible * unavailability of examiner
magnetic field modulation pillow for insomnia clinical trial

Conditions: Insomnia

Summary: this interventional study was designed to explore the clinical effect of magnetic field modulation system on insomnia patients and provide a new solution for insomnia treatment.

patients with insomnia receiving this sleep pillow with magnetic system or not would be observed in months.the effect of sleep pillow with magnetic system for insomnia would evaluated.

Eligibility criteria:
inclusion criteria: 1.18 to 65 years old. 2.primary insomnia exclusion criteria: 1. secondary insomnia 2. pilot, high-altitude operator 3. pregnant, lactating women 4. patients with serious disease 5. the researchers believe that the candidates are not eligible

Keywords: insomnia treatment magnetic field modulation
respiratory tract inflammation in children with inflammatory bowel disease (ibd)

Conditions: Inflammatory Bowel Disease

Summary: the purpose of this study is to determine whether inflammatory bowel disease in children involve the respiratory tract as expressed by increased levels of the fraction of exhaled nitric oxide (feno) and spirometry.

inflammatory bowel disease, crohn's disease (cd) and ulcerative colitis (uc) are chronic inflammatory diseases with remissions and exacerbations. cd and uc are associated with a variety of systemic (extra-intestinal) manifestations. in some studies, clinical and subclinical pulmonary abnormalities are described in active ibd as well as in the stable situation. nitric oxide (no) is an important mediator of inflammation in several pathological conditions.patients with lung diseases, like asthma, have higher levels of the fraction of exhaled nitric oxide (feno) in active disease in comparison with healthy volunteers. one study in adult ibd patients showed increase in feno levels in those patients, with positive correlation with the disease activity and negative correlation between the disease activity and pulmonary functions. we hypothesised that respiratory tract inflammation as expressed by feno and spirometry in pediatric ibd patients will correlate to the activity of the primary disease. methods: feno levels and spirometry will be assess for 40 patients with cd or uc (age 4-18 years) during remissions and exacerbations, calculated by the pediatrics crohn's disease activity index (pcdai) and the pediatrics ulcerative colitis activity index (pucai), respectively. two aged matched groups, the first of healthy children and the second of chronic abdominal pain will serve a controls.

Eligibility criteria:
inclusion criteria: 1. 4-18 years old children diagnosed with ibd: * histological diagnosis of crohn's disease * histological diagnosis of ulcerative colitis 2. negative stool cultures exclusion criteria: 1. respiratory tract infection during the 6 weeks prior to enrollment 2. diagnosis of asthma 3. current treatment with steroids 4. smoking
post market ats 3f® aortic bioprosthesis, model 1000, size 19mm

Conditions: Heart Valve Diseases

Summary: the purpose of this study is to evaluate the safety and efficacy of the ats 3f® aortic bioprosthesis, model 1000 (equine pericardial bioprothesis) size 19mm in a patient population undergoing isolated aortic valve replacement of his/her native aortic valve, or replacement of a failed prosthesis.

a multi-center, post market, non-randomized trial, designed to obtain safety and efficacy data from patients implanted with the size 19mm model 1000 heart valve. each enrolled patient will be followed until one year post-implantation. data will be collected both retrospectively and prospectively, on patients who were implanted from 1-jan-2009 to 31-dec-2009 with the 19mm model 1000. the data collected will be pooled with the data currently collected, under the u.s. food and drug administration (fda) ide number g01284 for submission to the u.s. fda.

Eligibility criteria:
inclusion criteria: * the patient required isolated aortic valve replacement with or without concomitant procedures such as coronary artery bypass or another valve reconstruction with an ats 3f® aortic bioprosthesis model 1000 (size 19mm) between the dates of 1-jan-2009 and 31-dec-2009. the three remaining heart valves must be of native tissue. * the patient is geographically stable and willing to return to the implant center for any required follow-up visits. * the patient has been adequately informed and consents to his/her participation in the clinical study, and of what will be required of him/her, in order to comply with the protocol. exclusion criteria: * the patient is twenty (20) or less than twenty years of age. * the patient is an intravenous drug and/or alcohol abuser. * the patient presented for implant with active endocarditis. * the patient presented for implant with congenital bicuspid aortic anatomy. * the patient had a previously implanted prosthetic valve that was not replaced by the study valve. * the patient required mitral, tricuspid or pulmonic valve replacement.

Keywords: isolated aortic valve replacement heart valve
a multiple dose study of pf-04360365 in patients with mild to moderate alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to determine whether multiple dose administration is safe and well tolerated in patients with mild to moderate alzheimer's disease.


Eligibility criteria:
inclusion criteria: * males or females of non childbearing potential, age \> or = 50. * diagnosis of probable alzheimer's disease, consistent with criteria from both: * national institute of neurological and communicable disease and stroke and alzheimer's disease and related disorders association (nincds-adrda). * diagnostic and statistical manual of mental disorders (dsm iv). * mini-mental status exam score of 16-26 inclusive. * rosen-modified hachinski ischemia score of \< or = 4. exclusion criteria: * diagnosis or history of other demential or neurodegenerative disorders. * diagnosis or history of clinically significant cerebrovascular disease. * specific findings on magnetic resonance imaging (mri); cortical infarct, micro hemorrhage, multiple white matter lacunes, extensive white matter abnormalities. * history of autoimmune disorders. * history of allergic or anaphylactic reactions.

Keywords: alzheimer's disease amyloid imaging antibody
til injection for the treatment of metastatic or recurrent solid tumors

Conditions: Solid Tumors, Adult

Summary: this is a multicenter, single-arm phase i clinical trial.the study process was divided into: screening period, sampling and production period, nma-ld chemotherapy , treatment and observation period, and follow-up period.


Eligibility criteria:
inclusion criteria: * 1. the patients (or legally authorized representative) patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (icf) approved by an institutional review board/independent ethics committee (irb/iec), must have the ability to understand the requirements of the study; * 2.must have a confirmed diagnosis of malignancy of their receptive histologies or cytologies: unresectable recurrent or metastatic solid tumor; * 3.at least one resectable lesion (preferably superficial metastatic lymph nodes) that has not been treated with radiation and has not received other local therapies. the separated tissues mass weighing ≥0.5cm (either of single lesion origin or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes. minimally invasive treatment where possible; exclusion criteria: * 1. patients who have symptomatic and/or untreated cns metastases (except stable brain metastases, no medication required within 3 months, no hormone dependence); * 2.the patient who has any active autoimmune disease, history of autoimmune disease, need for systemic steroid hormones or a condition requiring immunosuppressive drug therapy (\>10 mg/day of prednisone or equivalent hormone); * 3. arterial/venous thrombotic events within 5 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring; * 4.active infections requiring treatment with systemic anti-infectives (except for topical antibiotics); or those with unexplained fever \> 38.5℃ occurring during the screening period, except for tumor fever; * 5. patients who have refractory or intractable epilepsy, hydrops abdominis, active gastrointestinal bleeding or il-2 contraindications; * 6. patients who have received allogeneic bone marrow transplantation or an organ allograft; * 7.patients who have a history of hypersensitivity to any component or excipient of study drugs: autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, il-2, dimethyl sulfoxide (dmso), human serum albumin (hsa), dextran-40 and antibiotics (beta lactam antibiotics, gentamicin);
evaluation of the adherence and the patient acceptability of zomacton® treatment with the zomajet® vision x device

Conditions: Growth Hormone Deficiency; Turner's Syndrome

Summary: the study is performed to collect long-term data on the treatment adherence and patient's acceptability when zomacton®10 mg is administered with the zomajet® vision x device in patients with a growth hormone deficiency or turner's syndrome.


Eligibility criteria:
inclusion criteria: * patient with growth hormone deficiency, 1. diagnosis of growth hormone deficiency proven by appropriate exploration 2. size ≤ -2 standard deviation (sd) according to the french references 3. growth velocity in the previous year inferior to the normal for age (-1sd) or \< 4cm/year * growth deficiency due to turner's syndrome 1. turner's syndrome confirmed by a karyotype 2. patient's size ≤ -2 sd according to the french references 3. bone age \< 12 years * patient who require a minimum of 18 months of treatment. exclusion criteria: * there are no exclusion criteria except the contraindication for zomacton® 10 mg
intravenous palifosfamide-tris in combination with etoposide and carboplatin in patients with malignancies

Conditions: Malignancy; Cancer; Non Small Cell Lung Cancer; Small Cell Lung Cancer; Testicular Cancer; Thymoma; Ovarian Cancer; Osteosarcoma

Summary: this an an open-label study to define the safety profile and the maximum tolerated dose and confirm the clinical effective dose of palifosfamide-tris given intravenously in combination with etoposide and carboplatin in a wide range of cancers which etoposide and carboplatin are normally given. once the maximum dose of palifosfamide-tris is determined,a phase ii study using the 3 agents combined will begin.


Eligibility criteria:
inclusion criteria: * 18 years old or greater * malignancy scheduled to receive etoposide and carboplatin therapy * eastern cooperative oncology group (ecog) performance of 0 or 1 * adequate bone marrow, liver, renal function and coagulation status * informed consent * agree to use birth control through 28 days of last treatment dose * pregnancy test for women of child-bearing potential * no available standard therapy exclusion criteria: * allergy to the the study treatment drugs * unstable current medical condition * presence or history of injury to the urinary tract * active infection * major surgery within 4 weeks prior to treatment * minor surgery within 2 weeks prior to treatment * current acute steroid therapy or taper * currently pregnant or nursing * substance abuse or condition that may interfere with participation * received other investigational drugs within 30 days * within 4 weeks of their last chemotherapy

Keywords: malignancy etoposide and carboplatin non small cell lung cancer small cell lung cancer testicular cancer thymoma ovarian cancer osteosarcoma
almond butter and fasting glucose

Conditions: Type2 Diabetes

Summary: a two-period randomized crossover study will be conducted to determine the effect of almond butter as an evening snack on fasting blood glucose in adults with type 2 diabetes, not taking insulin.

control of fasting blood glucose is a challenge for many individuals with diabetes. researchers want to better understand how a nighttime snack can affect morning fasting blood glucose. a two-period randomized crossover trial will be conducted. participants will be randomized to receive each treatment for 1 week. during the almond butter treatment, participants will consume 2 tbsp of almond butter per day as an evening snack. the control treatments will be a no-snack control. fasting blood glucose, as well as glucose trends, will be measured using continuous glucose monitor (cgm). participants will also be asked to take simple cognitive tests on a study-provided smartphone each day of the study and report their daily food intake and physical activity.

Eligibility criteria:
inclusion criteria: * individuals with diagnosed type 2 diabetes * not on insulin therapy * on stable does of oral antihyperglycemic agent (no dose change for 6 months) * currently monitoring blood glucose at home via glucometer * willing and able to adhere to study protocol exclusion criteria: * individuals with type 1 diabetes, cardiovascular disease, kidney disease, liver disease, cancer or inflammatory conditions (e.g. gi disorders, rheumatoid arthritis) * women who are pregnant, breastfeeding, or have been pregnant within the last 6 months or breastfeeding within the last 6 weeks * individuals who smoke or use tobacco products * use of insulin therapy or sulfonylurea medications * allergy to any tree nut * liver or kidney disease * allergy to dexcom cgm adhesive
evaluating the shared decision making process scale in cancer screening decisions

Conditions: Breast Cancer Screening; Colon Cancer Screening; Prostate Cancer Screening

Summary: the purpose of this retrospective observational study is to evaluate the performance of the shared decision making process scale in a sample of patients who have received a decision aid about the decision to screen or not screen for breast cancer, colon cancer, prostate cancer, or lung cancer.

this is a retrospective observational study that will examine the performance of the shared decision making process in a sample of patients who made a decision about cancer screening in the last 2 years. patients from 4 hospitals who have received a patient decision aid for breast, colon, prostate, or lung cancer screening will be screened for eligibility. a random sample of eligible patients will be sent a one-time survey. the survey asks patients about their experiences talking with healthcare providers about the specific cancer screening decision. the survey includes the shared decision making process scale, knowledge, preferences, decisional conflict and decision regret. the study will obtain 400 completed surveys, or 100 for each cancer topic. the sample consists of patients who received a decision aid for cancer screening within the last two years and meet specific qualifications. all analyses will be conducted separately for each group, and results may be pooled. first, study staff examine the descriptives for the shared decision making process items. study staff will also test several hypotheses to examine performance of the scores such as whether higher shared decision making process scores are associated with less decisional conflict and less regret.

Eligibility criteria:
inclusion criteria: breast cancer group * female sex * between ages of 35-55 * no previous diagnosis of breast cancer colon cancer group * between ages of 45-75 * no previous diagnosis of colon cancer prostate cancer group * male sex * between ages of 45-74 * no previous diagnosis of prostate cancer lung cancer group * between ages of 50-80 * no previous diagnosis of lung cancer exclusion criteria: breast cancer group * unable to confirm primary language is english * history of breast cancer * severe cognitive impairment who cannot consent for themselves colon cancer group * unable to confirm primary language is english * history of colon cancer * severe cognitive impairment who cannot consent for themselves prostate cancer group * unable to confirm primary language is english * history of prostate cancer * severe cognitive impairment who cannot consent for themselves lung cancer group * unable to confirm primary language is english * history of lung cancer * severe cognitive impairment who cannot consent for themselves

Keywords: decision making decision aids decision quality instruments shared decision making cancer screening
evaluation of pharmacogenetic factors affecting fentanyl requirements for postoperative pain control

Conditions: Pain, Postoperative

Summary: fentanyl is a widely used opioid analgesic. there are big interindividual variabilities in dose requirements of fentanyl for postoperative pain control. this study aims to reveal the genetic factors affecting the variable requirements of fentanyl during postoperative period.

the candidate genes are oprm1, abcb1,cyp3a4 and cyp3a5.

Eligibility criteria:
inclusion criteria: * patients undergoing total abdominal hysterectomy (tah) or laparoscopy assisted vaginal hysterectomy (lavh) under general anesthesia * patients who want to use intravenous patient controlled analgesia (pca) after surgery * asa physical status class i, ii exclusion criteria: * history of drug addiction * opioid medication within 12 hours before surgery * previous history of opioid medication for 3 months * neurologic disorder * cardiac disorder * hepatic disease * renal disease * respiratory disease such as copd, asthma * sleep apnea * bmi \> 30 * psycotic disorder

Keywords: pharmacogenetics
blocking blue light in pregnancy, effects on melatonin profile and sleep

Conditions: Sleep Disturbance

Summary: sleep disturbances are common in pregnancy, and the incidence increases during the third trimester. light and specially the blue wavelengths of light, is affecting sleep and the circadian rhythm. the main aim of this randomized controlled study is to investigate the effect of blue-blocking glasses (bb-glasses) used in the evening and night on sleep and mood in pregnant women in the third trimester. the outcome measures assess sleep variables, alertness, melatonin level, sleepiness (subjectively), mood and symptoms of anxiety and depression. in addition we want to measure the pregnancy related sleep problems, alcohol intake, physical activity and perceives stress in the study population, and the association with daily/nightly light exposure.

several hormonal and mechanical influences can cause insomnia in pregnancy, and insomnia has been reported by 62% of pregnant women, a number that is significantly higher than found in the general population (10-15%). disrupted sleep among pregnant women also includes nocturia (a frequent need to get up and urinate at night), dyspnea (shortness of breath), nasal congestion, muscular aches and pelvic pains, fetal activity, leg cramps as well as reflux. artificial light in the evening and during the night increases alertness, disturbs sleep, shifts the timing of the circadian clock and impairs the brains' restorative slow waves during deep sleep. recent studies have however shown that use of bb-glasses in the evening improves sleep quality (subjectively reported) among persons with insomnia, and prevent alertness caused by blue-light emitting screens which are part of devices such as smart-phones and tablets. this project will contribute with new knowledge on how filtering nightly light exposure in pregnant women in their third trimester affects their sleep and mood. importantly, the project initiates new research on a potential non-pharmacological treatment of sleep disturbances by blocking blue wavelengths of light in the evening and during nocturnal awakenings. blue light is known to increase alertness through a recently described retinal receptor; the intrinsically photoresponsive retinal ganglion cell (iprgc), specialized for detecting daytime light signal. this project is highly innovative and may have significant practical implications due to the variety of aims and outcome measures, we plan to present the outcomes in separate articles.

Eligibility criteria:
inclusion criteria: * nulliparous women * expecting one child * being in the third trimester of a normal pregnancy * able to wear an actigraph during daytime and nighttime * able to fill out a questionnaire in norwegian exclusion criteria: * somatic or psychiatric disorders * fever and other health conditions affecting sleep * working at night during the study protocol

Keywords: pregnancy blue-blockers sleep quality melatonin
dermarep™ device in the treatment of venous leg ulcers

Conditions: Venous Leg Ulcer

Summary: this is a first in human clinical study on the safety and effectiveness of dermarep™ wound contact dressing. patients with venous leg ulcers will be treated with standard of care dressings and compression for 4 weeks to establish a baseline wound healing response. all patients will then be treated with dermarep™ wound contact dressing in addition to standard of care for a further 8 weeks. if the wound has not healed, patients will continue treatment with standard of care only for a further 4 weeks. all patients will be assessed at the 16 week timepoint, the primary endpoint.


Eligibility criteria:
inclusion criteria: * the patient is at least 18 years of age * the patient is male and female not pregnant or lactating and using contraception * the patient has a confirmed venous leg ulcer with:confirmed actively managed reflux; no exposed tendon or bone; ulcer surface area between 2cm2 and 80cm; abpi\>0.8 * the patient agrees to abstain from enrolment in any other clinical trial for the duration of the study * the patient is able to understand the aims and objectives of the trial and is willing to consent exclusion criteria: * study treatment area has exposed bone or tendon * poorly controlled diabetes * arterial insufficiency (abpi\<0.8) * pregnant/lactating females (tested as per institutional requirements) * the patient has a severe dermatological disorder (e.g. severe psoriasis, epidermolysis bullosa, pyoderma granulosum) * the patient is unable to follow the procedures set by the protocol * the patient has a history of any significant cardiac, pulmonary, renal. hepatic, neurological and/or immune dysfunction that in the opinion of the investigator may compromise patient safety or study objectives * the patient is taking any known medications that in the opinion of the investigator may compromise patient safety or the study objectives * the patient has any known allergies to any of the device materials to be used in the trial (egg allergy) * the patient is a vulnerable or protected adult * the patient is unable to provide consent