Kornimate/medical-research-clean huggingface dataset:
multicomponent behavioral sleep intervention for insomnia in older adults with mild cognitive impairment

Conditions: Mild Cognitive Impairment; Insomnia

Summary: insomnia symptoms in older adults with mild cognitive impairment represent a significant public health burden in terms of impaired quality of life, risks from untreated insomnia, and risks from pharmaceutical insomnia treatment. to address the limitations in the most effective non-pharmacological treatments for insomnia in older adults with mild cognitive impairment, a randomized pilot study will be conducted to test a brief (4 week), tablet-based, personalized, multicomponent behavioral sleep intervention for insomnia, compared to a sleep education control, in this at-risk group. the findings of the proposed project will inform future, larger scale clinical trials and may provide a novel and innovative way for older adults with mild cognitive impairment to achieve better sleep and health-related quality of life outcomes.


Eligibility criteria:
inclusion criteria: * 1) age 55 and older * 2) mild cognitive impairment (mci) the telephone interview for cognitive status 13-item modified (tics-m) version will be used to screen participants for eligibility in the study. we will include participants with tics-m scores of 28-36, based off ranges and optimal cutpoints determined in various studies. * 3) have insomnia symptoms a)answer yes to "do you have trouble falling asleep, staying asleep, awakening too early, or have unrefreshing sleep" and b) have subjective sleep diary evidence of insomnia, with an average sleep onset latency \>30 min or wakefulness after sleep onset of \>60 min during the one week pre-treatment assessment * 4) live in the community * 5) speak english as primary language exclusion criteria: * 1) presence of moderate to severe cognitive impairment defined as tics score \<28 * 2) visual or manual dexterity impairment that prevents them from pressing yes/no buttons, or selecting a number at 24 point font * 3) current sedative-hypnotic or other sleep aid use on a regular or as needed schedule within the prior three months * 4) presence of an acute medical or psychiatric condition which, in the judgement of the research team, would interfere with the subject's ability to realistically follow the study protocol
physical therapy for in-patients with severe anorexia nervosa

Conditions: Anorexia Nervosa

Summary: in-patients with severe anorexia nervosa (an) often drop out of treatment, because of ambivalence towards treatment and anxiety for weight gain. however, physical therapy has shown some positive effects on symptoms of an. this study aims to investigate the feasibility of a randomized control trial (rct) of a standardized physiotherapeutic program for patients with severe an with compliance to nutritional therapy as the primary outcome measure.

anorexia nervosa (an) is a serious and complex disease with unknown etiology. it is characterised by disturbed body image and extreme and devastating fear of gaining weight. the illness leads to a considerable and sometimes dangerous weight loss because of the limited food intake and often an exaggerated exercise behavior. an can affect people of all ages and of both sexes, but girls or young women are more at risk. the prevalence among young women in denmark is estimated to be between 0.4% and 1%. an is associated with a high rate of comorbidity and mortality. the treatment of an consist of re-feeding and psychotherapy. different therapeutic methods and theories have been applied, but none have shown to be superior. the patient alliance and motivation for treatment seem to be essential for a successful treatment. drop-out is a common challenge. hence, attention must be directed to how the therapeutic alliance and the patient's motivation can be optimized in order to secure a better treatment effect. studies have shown that physical therapy, including supervised exercise and bodily focused interventions, may have a positive effect on symptoms of an. it may reduce the distorted body image and anxiety. however, it is unknown whether physical therapy can affect compliance and drop out rate to the nutrition therapy. the objective of this study is to investigate the feasibility of a rct design in this group of patients with severe an at a specialized unit. the intervention is supervised, standardized physical therapeutic exercises mainly consisting of light strength training. the development of the intervention is based partly on the literature, and partly on interviews and observations with two patients with severe an.

Eligibility criteria:
inclusion criteria: * patients admitted to the specialized nutrition section at odense university hospital and are fulfilling diagnostic and statistical manual (dsm)-5 criteria for an. * 18 years of age or older * patients who can be included within the first two weeks of hospitalization exclusion criteria: * patients who can not fill in a danish-language questionnaire. * patients who are not able to be in standing position. * patients who are not respiratory and circulatory stable.
syl040012. tolerance and effect on intraocular pressure in subjects with intraocular pressure (iop) >= 21 mm hg

Conditions: Glaucoma; Ocular Hypertension

Summary: the aim of this study is to evaluate the tolerance and effect on unmedicated subjects with elevated iop.

the aim of this study is to evaluate the tolerance and effect on unmedicated subjects with elevated iop. an unmedicated subject is considered a person without any iop/glaucoma treatment at least one month before recruitment.

Eligibility criteria:
inclusion criteria: * both genders. * \>/= 18 years of age with elevated iop with oag diagnosis. * subjects must provide signed informed consent prior to participation in any study-related procedures * iop \>/= 21 mmhg and \< 30 mmhg in three different assessment days. * normal ocular test (in both eyes): * visual field: 24-2 or equivalent * normal oct * bcva: \>/= 0,5 (20/40) snellen scale, or \</=0.3 logmar. * normal schirmer test . * normal funduscopy. exclusion criteria: * pregnant or breastfeeding females or those with a positive pregnancy test. females of childbearing potential who will not use a medically acceptable contraceptive method from selection and during the hole study. * current relevant disease, including respiratory disease, cardiovascular, endocrine, neurological, hematological, renal, neoplastic, hepatopathy, gastrointestinal distress, hypertension or infectious acute processes. * previous chronic processes or with rebound characteristics that could interfere with the study according to the investigator's judgment. * having used betablockers and corticoids sporadically in the last 15 days whichever the route of administration. * previous eye refractive surgery * subjects with visual alteration with more than 3 dioptres for hypermetropy and/or astigmatism. * use of contact lenses during the last 7 days before starting the treatment. * subjects who has participated in a clinical trial during the past 2 months before study entry. * analytic alterations medically relevant, at investigator judgment. * positive results in test drug abuse during selection period. * subjects with at least 2 visual fields or fiber layer measured in two different days abnormals * history of ocular infection or inflammation within the past 3 months * pachymetry(in the middle of the cornea) \>600 microm or \< 500 microm. * subjects with iop associated to close angle glaucoma * history of chronic or severe acute ocular disease (i.e. scleritis, uveitis, blepharitis, conjunctivitis or herpes simplex virus) * history of intolerance to any of the components of the drug formulation * subjects with previous iridotomy with iop related with close angle glaucoma. * previous ocular surgery in glaucoma * corneal refractive surgery (e.g., keratotomy, prk, lasik, etc)

Keywords: glaucoma iop sirnas rnai beta inhibitor
prolift versus ivs for pelvic floor prolapse

Conditions: Pelvic Floor Prolapse

Summary: * women who underwent mesh or sling procedures to correct pelvic organ prolapse will be enrolled. * their data will be collected from the files. * comparison between two groups will be carried our: those who underwent a posterior ivs and those who underwent posterior prolift procedure. * the data will be obtained by questionaires by a telephone interview by a physician who did not participate in the surgery. * follow-up physical examination data will also be obtained.


Eligibility criteria:
inclusion criteria: * women who previously underwent surgery for pelvic floor prolapse at least a year before exclusion criteria: * women who did not have surgery for pelvic floor prolapse

Keywords: pelvic floor prolapse prolift ivs surgery
tools for therapeutic evaluation in charcot-marie-tooth disease type 1a: outcome measures and biomarkers

Conditions: Charcot-Marie-Tooth Disease Type 1A

Summary: this is a 2-year follow-up study of a cohort of 60 cmt1a patients. the objective is to identify markers allowing to better understand the phenotypic variability observed on patients with cmt1a, to identify predictive markers of the disease's progression and to provide validated measurement tools that can be used as outcome measures in future clinical trials.


Eligibility criteria:
inclusion criteria: * patients with cmt 1a disease * diagnosis of cmt 1a confirmed by genotyping (duplication of the 17p11.2 region) exclusion criteria: * patients suffering from co-morbidity at the origin of peripheral neuropathy (diabetes, hypothyroidism, renal insufficiency, drugs...) or muscle, articular, rheumatological disease * with hiv or cancer * with a significant progressive disease in the previous month * with a contra-indication for mri * with a dislocation, fracture, or recent surgery (less than 6 months before inclusion) * with alcohol or psychoactive substances abuse * treated by an anti-inflammatory drug over the past four weeks * pregnant or breastfeeding women * homeless patients
evaluation of diagnostic performance of visiocyt® test, in case of suspicion of urothelial bladder tumors

Conditions: Bladder Cancer

Summary: this clinical study is designed to evaluate the diagnostic performance of visiocyt test, which would improve the early diagnosis of bladder cancer in order to optimize the management of individual patients as part of a cancer diagnostic monitoring. the diagnostic method of visiocyt® device is based on the analysis by transmission and fluorescence, of urinary cytology slides prepared according to the protocol visiocyt.

this clinical trial is divided into two main phases: i. the first one involves the construction of better image processing algorithm from a learning sample. the learning sample will include 600 virtual slides made from the urine sample of the first 600 patients enrolled. ii. the second one, will evaluate from an evaluation sample, the diagnostic performance of the test visiocyt, to identify patients with versus without bladder tumors, using as comparator the results of the examination of reference: histology. the evaluation sample will include 400 slides, made from the urine sample of the last 400 patients enrolled.

Eligibility criteria:
inclusion criteria: * age ≥18 years * patient affiliated to a social security system * patient able to understand the protocol. * signature of patient consent form before the start of the study * negative urine culture * patient for which is programmed a bladder endoscopy for : * suspected bladder cancer (de novo, monitoring or relapse) * exploration lower urinary tract excluding a suspected bladder cancer or prostate cancer exclusion criteria: * age \<18 years * ongoing urinary tract infection untreated * private person of liberty or under guardianship (including guardianship) * bladder cancer excluding urothelial carcinoma * carcinoma of high urinary tract, associated * lithiasis pathology * patient who underwent renal transplantation
phase i and ii study of auranofin in chronic lymphocytic leukemia (cll)

Conditions: Chronic Lymphocytic Leukemia (CLL); Small Lymphocytic Lymphoma; Leukemia, Prolymphocytic

Summary: the purpose of this study is to evaluate the safety and effectiveness of auranofin to treat patients with chronic lymphocytic leukemia (cll), small lymphocytic lymphoma (sll), or prolymphocytic lymphoma (pll).


Eligibility criteria:
inclusion criteria: * histologically confirmed b-cell chronic lymphocytic leukemia (cll), small lymphocytic lymphoma (sll), prolymphocytic leukemia arising from cll/sll or richter's transformation according to who criteria who require therapy based on the 2008 revised iwcll criteria. * relapsed or refractory disease after receiving at least 1 prior therapy for cll * at least 18 years old; ecog status of 1 or less; life expectancy 2 months or greater * adequate organ and marrow function (total bilirubin less than 1.5x iuln; alt less than 2x iuln; serum creatinine less than 1.5x uln) exclusion criteria: * have had chemotherapy, radiotherapy or immunotherapy within 4 weeks prior to entering study * have not recovered from aes due to agents administered more than 4 weeks prior * receiving any other investigational agent * known second malignancy that limits survival to less than 2 years * known hiv positive * uncontrolled intercurrent illness * pregnant or breastfeeding

Keywords: auranofin chronic lymphocytic leukemia relapsed refractory cll sll pll
propofol pharmacokinetics and pharmacodynamics during cardiopulmonary bypass

Conditions: Coronary Artery Disease; Cardiopulmonary Bypass; Coronary Artery Bypass Graft

Summary: cardiopulmonary bypass (cpb) is known to alter pharmacokinetics (pk) and brain sensitivity to several drugs, including propofol. few studies, however, have tested if propofol pharmacokinetical alterations observed after cpb could contribute to the increased hypnotic effect of propofol after cpb. this study was designed to test the hypothesis that changes in the pk of propofol contribute to an increase in its hypnotic effects after cpb as evidenced by changes in bispectral index (bis) values. twenty undergoing coronary artery bypass graft patients will be allocated in two groups: 1) cpb groups and 2) off-pump coronary artery bypass graft. bispectral index values and blood samples for plasma propofol concentration measurements will be collected along the surgery and up to 12 hours in the post-operative period. plasma propofol concentrations, bispectral index values and propofol pk will be compared between the groups.


Eligibility criteria:
inclusion criteria: * isolated coronary artery bypass indication * left ventricular ejection fraction greater than 50 % * absence of preoperative pulmonary dysfunction exclusion criteria: * intra and postoperative circulatory shock * postoperative pulmonary dysfunction

Keywords: cardiopulmonary bypass coronary artery bypass graft coronary artery disease propofol pharmacokinetics pharmacodynamics
a phase 1 study of amv564 in patients with intermediate or high-risk myelodysplastic syndromes

Conditions: Myelodysplastic Syndrome (MDS)

Summary: an open label, phase 1, study of amv564 as monotherapy to assess the safety and efficacy in patients with myelodysplastic syndromes

a dose-escalation with expansion study of amv564 (t cell engager) as monotherapy in patients with intermediate-2 or high-risk myelodysplastic syndromes

Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * diagnosis of mds according to who 2016 criteria * ecog performance status of 0 or 1 * intermediate-2 or high-risk disease per ipss * fewer than 20% blasts in the bone marrow or peripheral blood * disease that is refractory to or relapsed from either a hypomethylating agent (e.g. decitabine or azacitidine) or a standard aml-type intensive regimen * adequate organ function * prior allogeneic transplant performed ≥ 3 months prior to first dose of amv564 is allowed provided there is no evidence of active graft-versus-host disease (gvhd) and the patient has been off immunosuppressive therapy for ≥ 4 weeks. exclusion criteria: * history of, or known, central nervous system (cns) disease involvement, or prior history of national cancer institute (nci) common toxicity criteria for adverse events (ctcae) grade ≥ 3 drug-related cns toxicity * prior allogeneic transplant if performed \< 3 months prior to first dose of amv564, if patient has active gvhd, or if patient has not been off immunosuppressive * prior treatment with a therapeutic agent targeting cd33 (e.g. gemtuzumab ozogamicin, sgn-cd33a or amg 330).
a comparison of three different treatment options for irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: irritable bowel syndrome is a common disease to which there is no curable treatment. diet is considered to trigger symptoms associated with the clinical picture of ibs, and dietary treatment is thus believed to relieve the symptoms of ibs. as the disease is very heterogeneous in its manifestation, different treatment options might be indicated depending on the predominant symptom. to investigate the response to different dietary treatment options, a randomized controlled intervention trial will be carried out in adult patients (\>18 y) with ibs according to rome iv criteria. the aim of this study is to compare the response to two different dietary treatments or optimized medical treatment.

the study is a randomized controlled trial comparing three different treatments during four weeks: 1. combination of low fodmap diet + traditional dietary advice (based on nice recommendations) * eat at regular hours; 3 main meals and 3 snacks * eat in peace, chew the food properly * peel all fruits and vegetables * limit intake of spicy and fatty foods, coffe, alcohol, avoid fizzy drinks and chewing gum * choose soluble rather than insoluble fibres * avoid foods high in fodmaps 2. diet low in carbohydrates * 10 e% carbohydrates, 23 e% protein, 67 e% fat * larger amounts of fish, shellfish, meat, egg, dairy products (lactose free if wanted) nuts, seeds, oil, vegetables * no sugary or starchy foods, e.g pasta, potatoes, bread, rice, most fruits * no specific consideration about fodmap content 3. optimized pharmacological tretament based on predominant symptom and previous experience with pharmacological treatmment. pain/discomfort: * pain: amitriptyline 25 mg. increase to 50 mg if needed * episodic pain: hyoscyamine 0,2mg 2x2; adjust dose if needed * pain with diarrhea: amitriptyline 25 mg. increase dose if needed * pain with constipation: linaclotide 290 microgram 1x1 constipation: * bulking agent (sterculia gum (inolaxol) 1x1. increase to 1x3 if needed * osmotic laxative (macrogol (movicol) 1x1 * linaclotide 290 microgram 1x1 diarrhea * loperamide 1x2 . adjust dose if needed * cholestyramine 1x1. increase ever 3-5 d as needed * ondansetron 4mg 1x1. increase to 1x2-3 if needed * eluxadoline 100mg 1x2 primary endpoint: ibs-sss reduction \>50 points

Eligibility criteria:
inclusion criteria: * ibs according to rome iv criteria, bmi 18-35, ability to communicate in swedish, gothenburg region resident exclusion criteria: * heart, liver, neurologic or psychiatric disease or illness * serious gastrointestinal diseases * celiac disease * diabetes * other conditions or surgery that affects the gastrointestinal function * hyperlipidemia * food allergy or intolerance other than lactose * adherence to a specific diet * being pregnant or breastfeeding * previously been treated with any of the intervention arms, including having tested all of the pharmacological treatment options of relevance for the symptom profile of the patient

Keywords: fodmaps carbohydrates metabolomics microbiota
mri evaluation of iron overload in the heart, liver and pancreas in patients receiving multiple blood transfusions.

Conditions: Iron Overload

Summary: sickle cell anemia and sickle cell β thalassemia patients require multiple transfusions in order to avoid chronic anemia sequel. this regimen entails intrinsic deleterious effects, the majority of which are related to iron deposition in the reticuloendothelial system. thus, iron is deposited in hepatic, myocardial and endocrine glands tissues. tools available for iron load evaluation include serum ferrtin levels, liver biopsy and echocardiography, all are non specific. the purpose of this work is to compare iron overload in the liver, heart and pancreas in sickle cell anemia and sickle cell β thalassemia patients using t2\* mri sequences.

sickle cell anemia and sickle cell β thalassemia patients recieving multiple transfusions are exposed to the effects of iron deposition in the reticuloendothelial system, including cardiac muscle, liver and pancreas. tools available for iron load evaluation include serum ferrtin levels, liver biopsy and echocardiography, all are non specific. the purpose of this work is to compare iron overload in the liver, heart and pancreas in sickle cell anemia and sickle cell β thalassemia patients using t2\* mri sequences. patients and methods: 27 sickle cell anemia and 28 sickle cell β thalassemia will undergo transthoracic echocardiography, cardiac mri using t2\* sequences and clinical and laboratory evaluation for iron overload including ferritin levels and oral glucose tolerance test .

Eligibility criteria:
inclusion criteria: * clinical diagnosis of sickle cell anemia or sickle cell β thalassemia having received multiple blood transfusions. exclusion criteria: * contraindication to mri

Keywords: iron overload thalassemia anemia, sickle cell magnetic resonance imaging