Kornimate/medical-research-clean huggingface dataset:
physical activity and arts

Conditions: Infertility; Obesity; Stable BMI

Summary: obese women experience increased infertility rate and longer time to conception showing lower pregnancy and live-birth rates both in natural and assisted conceptions. body weight loss improves not only spontaneous pregnancy rates but also those of assisted reproductive techniques (arts). almost all studies refer to body weight loss due to lifestyle intervention programs consisting in hypocaloric diet and increased physical activity, whereas very little is known about the specific effects of physical activity alone on human reproduction. in a previous retrospective study, we demonstrated that physical activity enhances the reproductive performance of obese infertile patients who receive in vitro fertilization (ivf) and intracytoplasmic sperm injection (icsi) cycles, regardless of body weight loss. the aim of this randomized controlled trial (rct) will be to evaluate if a structured exercise program improve the effectiveness of arts.

women with primary infertility scheduled to an ivf/icsi procedure, obese and with a stable bmi will be randomized to receive a structured exercise program or nothing. patients will undergo a gonadotropin ovarian hyperstimulation for standard ivf/icsi procedure. clinical and biological data will be evaluated in each subject.

Eligibility criteria:
inclusion criteria: * infertility * obesity * stable bmi * schedule for arts exclusion criteria: * use of cryopreserved embryos * any changes in diet and physical activity * tobacco smoking * drug use * alcohol abuse * uterine diseases * previous pelvic surgery * major medical diseases * clinical history of (or suspicion of) endometriosis, antiphospholipid antibody syndrome, recurrent miscarriage * obese partner * severe sperm pathology

Keywords: set infertility ivf/icsi pregnancy
nitazoxanide for treatment of cryptosporidium in children

Conditions: Cryptosporidiosis

Summary: the goal of this clinical trial is to learn if nitazoxanide (ntz) can treat cryptosporidium infection in children age 6-12 months. the main questions it aims to answer are: * does ntz treatment of diarrheal cryptosporidium infection lower the number of days of diarrhea? * does ntz treatment of diarrheal and non-diarrheal cryptosporidium infection lower the number of days that parasites can be found in the stool? researchers will compare ntz to a placebo (a look-alike substance that contains no drug) to see if ntz works to treat cryptosporidium. participants will: * take ntz or placebo for 3 days * receive regular visits from field research assistants * provide blood and urine samples


Eligibility criteria:
inclusion criteria: * tests positive for cryptosporidium by stool point-of-care test, with or without active diarrhea * family plans on remaining in the area for next 6 months exclusion criteria: * history of hypersensitivity to nitazoxanide. * taking warfarin. tizoxanide, the metabolite of nitazoxanide is highly bound to plasma proteins and may compete with binding sites of other highly plasma bound drugs with narrow therapeutic indices, including warfarin. * history of renal insufficiency or a baseline serum creatinine = 40 µmol/l. renal clearance of the drug has not been studied. * history of hepatic dysfunction or serum aspartate aminotransferase (ast) ; * 50 u/l, serum alanine transaminase (atl) ; * 50 u/l, or serum bilirubin ; * 23 µmol/l. hepatic clearance of the drug has not been studied.

Keywords: nitazoxanide
early treatment of cytokine storm syndrome in covid-19

Conditions: Cytokine Storm; COVID-19

Summary: this proposal addresses the problem of preventing the very high mortality and morbidity associated with the development of cytokine storm syndrome (css) associated respiratory failure in covid-19 infection.

the first aim of this project is to determine whether rapidly assayed early clinical laboratory markers of css (ecss: leucopenia, lymphopenia, and elevated ferritin, d-dimer, ldh, crp, and ast/alt) in patients admitted to the hospital with respiratory compromise in the setting of covid-19 infection can accurately identify patients with css as defined by validated css case definitions (h-score, ahlh-2004). confirmation of ecss predictive of evolving css will identify patients at risk for rapid deterioration of lung function and inform early initiation of treatment for css. genotyping studies will also be performed on patients with confirmed css to determine whether perforin pathway mutations commonly present in css associated with other disorders are present. the second aim is to determine whether early treatment with rhil-1ra (anakinra) in patients admitted to the hospital with markers of css improves or prevents deterioration of respiratory dysfunction and prevents the development of respiratory failure requiring mechanical ventilation.

Eligibility criteria:
inclusion criteria: 1. 18 years old or older 2. molecular (pcrna) diagnosis of sars-cov-2 infection 3. chest imaging studies consistent with covid-19 pneumonia 4. hyperferritinemia (\>700 ng/ml) 5. history of fever \>38 degrees c 6. any three of the following: 1. elevated d-dimer (\> 500 ng/ml) 2. thrombocytopenia (\< 130,000/mm3) 3. leucopenia (wbc \<3500/mm3) or lymphopenia (\<1000/mm3) 4. elevated ast or alt (\> 2x uln) 5. elevated ldh (\> 2x uln) 6. crp \> 100 mg/l exclusion criteria: 1. participation in other investigational treatment protocols for covid-19 infection 2. culture confirmed active bacterial infection requiring antibiotic therapy 3. on mechanical ventilation 4. previous known hypersensitivity reaction to anakinra 5. previous known hypersensitivity reaction to e coli derived proteins 6. pregnant or breast-feeding females
prediction of undesired obstruction in external ventricular drains.

Conditions: Intensive Care Unit; Intraventricular Hemorrhage; External Ventricular Drain

Summary: acute obstructive hydrocephalus often complicates intraventricular hemorrhage (ivh). the insertion of an external ventricular drain (evd) is typically necessary in order to alleviate intracranial pressure by draining excess fluid. however, dysfunction of the evd whether due to malposition or obstruction, can exacerbate hydrocephalus in an already compromised brain. evd dysfunction must therefore be promptly detected and treated. consequently, identifying high-risk patients and closely monitoring them is imperative. while ivh is known to increase the risk of obstruction in the natural cerebrospinal fluid outflow tract, its association with ventricular drain obstruction remains unproven.


Eligibility criteria:
inclusion criteria : patient older than 18 years old, * admitted to the icu, * with first evd inserted for less than 12 hours, * and brain imaging (ct or mri) available in the timespan "24 hours before to 24 hours after" the evd insertion. exclusion criteria : * evd intentionally occluded immediately after its insertion, * purulent cerebrospinal fluid * pregnant or breast-feeding patient * moribund patient or patient with decision of withholding or withdrawing life-sustaining treatment within the 12 hours * patient with no health insurance * patient under guardianship

Keywords: intensive care unit external ventricular drain neuromeningeal infection obstruction intraventricular hemorrhage functional outcome
a double-blind, randomized, placebo-controlled, phase 2 trial of ykp3089 as adjunctive therapy in subjects with partial onset seizures

Conditions: Partial Epilepsy

Summary: this is a multicenter, double-blind, randomized, placebo-controlled dose response study, with an 8-week prospective baseline and an 18 week double-blind treatment period (including a 6-week titration phase and 12 week maintenance phase), followed by a 3-week blinded study drug taper period (for subjects leaving the study) or a 2-week blinded conversion period (for subjects who will participate in the open-label extension). the primary objective of this study is to determine the effective dose range of ykp3089 as adjunctive therapy for the treatment of partial seizures. the trial will also evaluate the safety and tolerability of ykp3089 in the partial epilepsy population.


Eligibility criteria:
inclusion criteria: * weight at least 40 kg * a diagnosis of partial epilepsy according to the international league against epilepsy's classification of epileptic seizures. diagnosis should have been established by clinical history and an electroencephalogram (eeg) that is consistent with localization related epilepsy; normal interictal eegs will be allowed provided that the subject meets the other diagnosis criterion (ie, clinical history) * have uncontrolled partial seizures despite having been treated with at least 1 aed within approximately the last 2 years * during the 8-week baseline period, subjects must have at least 8 partial seizures including only simple partial seizures with motor component, complex partial seizures, or secondarily generalized seizures without a seizure-free interval of greater than 25 days any time during the 8 weeks baseline. subjects must have at least 3 of these partial seizures during each of the two consecutive 4-week segments of the baseline period * currently on stable antiepileptic treatment regimen. exclusion criteria: * a history of nonepileptic or psychogenic seizures * presence of only nonmotor simple partial seizures or primary generalized epilepsies * presence or previous history of lennox-gastaut syndrome * an active cns infection, demyelinating disease, degenerative neurologic disease, or any cns disease deemed to be progressive during the course of the study that may confound the interpretation of the study results * any clinically significant psychiatric illness, psychological, or behavioral problems that, in the opinion of the investigator, would interfere with the subject's ability to participate in the study * history of alcoholism, drug abuse, or drug addiction within the past 2 years * history of status epilepticus within 3 months of visit 1 * a "yes" answer to question 1 or 2 of the c-ssrs (baseline/screening version) ideation section in the past 6 months or a "yes" answer to any of the suicidal behavior questions in the past 2 years * more than 1 lifetime suicide attempt * participation in any other trials involving an investigational product or device within 30 days of screening (or longer, as required by local regulations) * a history of any previous exposure to ykp3089
theory of mind in children with dcd

Conditions: Developmental Coordination Disorder

Summary: the aim of the study is to investigate theory of mind (tom) in children with developmental coordination disorder (dcd). dutch-speaking children, who are living in flanders or the netherlands (because comparisons will be made with flemish and dutch norms), will be included. in addition, children should be six until twelve years old with a dcd diagnosis confirmed by a multidisciplinary team (including a doctor). during the test moment, tom will be tested by tom test-r and the motor skills by mabc-2. beside, the tom test-r will be filmed, but the child's face not shown. the parent/legal guardian will be asked to complete five online questionnaires (demographic and developmental questionnaire, cvo, srs-2, sdq and tombc), this can be completed in advance at home or at the test moment (researchers provide a laptop).


Eligibility criteria:
inclusion criteria: * age of child: from six to 12 years old * confirmed diagnosis of dcd by a multidisciplinary team (including a physician) * child lives in flanders or the netherlands * child has dutch as the mother tongue exclusion criteria: * diagnosis of autism spectrum disorder (asd) * blood related siblings of the child * parent/legal guardian does not have an adequate level of dutch * (iq lower than 70) or (no iq information and child attends special education type 1 (mild intellectual disability) or type 2 (moderate to severe mental disability))

Keywords: child development theory of mind
clinical trial to evaluate the effect of a probiotic mixture on the rosacea evolution

Conditions: Rosacea; Rosacea Papular Type; Rosacea, Papulopustular

Summary: the clinical trial has a randomized, double-blind, placebo-controlled design, in which the aim is to evaluate the effect of a probiotic mix, with a 12-week treatment, on the evolution of rosacea. this 12 weeks of treatment are structured into three visits: visit 1 (initial; week 0), visit 2 (intermediate; week 6) and visit 3 (final; week 12).

the three visits that make up the study and the actions to be carried out in each of them are described below: visit 1 (initial; week 0) once the informed consent is signed, a doctor trained for the study performs the initial interview where it is verified that the patient meets all the inclusion criteria and none of the exclusion criteria and their medical history.the investigator will proceed to assign the patient the next study participant number and, according to a previously prepared randomization list, the treatment that they will receive during the study will be assigned. the investigator will assess the severity and symptoms of rosacea according to the investigator's global assessment (iga) and clinician erythema assessment (cea) scales. the patient will also complete a questionnaire to assess the impact on quality of life due to the disease: dermatology life quality index (dlqi). visit 2 (intermediate; week 6) in this intermediate visit, in addition to assessing the symptoms of the disease with the detailed scales, the investigator will record the adverse events reported by the patient, as well as the concomitant treatments used. also, the treatment compliance rate will be calculated by counting the capsules returned by the patient. visit 3 (final; week 12) in the final visit, the same actions will be carried out as in the intermediate visit, evaluating the severity of the disease and the remaining capsules will be collected, to calculate treatment compliance, concomitant treatments and adverse events. visit 4 (post-treatment follow-up; week 24) during this visit, the symptoms of the disease will be assessed with the two scales used in the study and the treatments that the patient has required during the 12 weeks after the end of the study treatment will be counted.

Eligibility criteria:
inclusion criteria: * patients of both sexes of an age equal to or greater than 18 years. * patients diagnosed with papulopustular rosacea with a minimum score of 2 points according to the investigator's global assessment (iga) index. * signature of informed consent by the patient exclusion criteria: * pregnant, lactating, and/or women who do not agree to use an effective contraceptive method during the development of the study. * allergy and/or intolerance to any of the components of the product under study. * consumption of antibiotics in the previous two weeks. * consumption of probiotics in the previous two months. * isotretinoin use in the previous six months. * light procedures (ipl, laser, kleresca) in the previous three months. * participation in other clinical studies in the previous two months. * other dermatological pathologies.
"aloft - aliskiren observation of heart failure treatment": efficacy and safety of aliskiren added on top of standard therapy in adults (≥ 18 years) with stable heart failure

Conditions: Heart Failure

Summary: this study was designed to determine if patients, who have both high blood pressure and heart failure and are currently receiving drug treatment for heart failure, have an improvement in their heart failure signs and symptoms and other indicators of heart failure after being treated with aliskiren on top of their current heart failure treatment. aliskiren is an investigational drug; its safety will also be evaluated in this trial.


Eligibility criteria:
inclusion criteria: * history of diagnosis or currently have high blood pressure * stable heart failure (nyha class 2-4) for at least 1 month before study entry. subject should be on a stable dose regimen of heart failure medication. * brain natriuretic peptide (bnp) \> 150 pg/ml at baseline (to be evaluated by physician at first visit) exclusion criteria: * previous treatment with aliskiren * high blood pressure due to secondary reasons or constant low blood pressure (systolic \< 90 mmhg) * history of heart attack or coronary bypass surgery in the past 6 months other protocol-defined exclusion criteria may apply.

Keywords: aliskiren, heart failure,hypertension
mapping of electrical properties in the brain

Conditions: Malignant Glioma

Summary: this study evaluates imaging methods for monitoring neural and electrical activity in the brain for improving clinical diagnosis.

primary objectives: i. optimize pulse sequence acquisitions for diffusion imaging on clinical mri vendor systems. ii. develop image-based mri models (including diffusion-based mri) that accurately depict the multi-regional electrical properties in the brain (e.g., resistivity, current) to inform of neural integrity and function (including white matter tract integrity) in diseased and non-diseased states. iii. compare/correlate image-based mri models (e.g., diffusion) with existing structural, physiologic, and functional mri methods (e.g., tensor imaging, fmri, dsc-mri, etc). iv. further train image-based models/measurements with loco-regional benchmarks including (but not exclusive to) electrophysiologic monitoring, functional and structural tissue assays (from available biopsies), and correlative clinical features (e.g., histology, outcomes, treatment, etc). outline: this is an observational study. participants complete a survey and undergo mri on study.

Eligibility criteria:
inclusion criteria: * aim 1: normal healthy volunteers * aim 2, 3, 4: participants included in irb 16-002424, including those that have undergone surgical biopsy/resection for suspected or known glioma exclusion criteria: * healthy volunteer unable to have an mri
cognitive behavioral therapy for painful diabetic neuropathy

Conditions: Diabetic Neuropathy

Summary: the primary objective of this study is to evaluate the usefulness of cognitive behavioral therapy (cbt) for the management of painful diabetic neuropathy. participants will be randomly assigned to one of two treatment conditions: cbt plus standard medical care or standard medical care alone. cbt will be offered in ten, ninety-minute group sessions and will be provided by a psychologist with experience in the management of both diabetes and chronic pain. cbt will involve teaching and encouraging practice of adaptive pain coping skills such as relaxation skills, activity pacing, and positive self-statements, among others. this study will allow us to determine which treatment is superior in terms of improvements in pain management, functioning and overall quality of life.

research design: a randomized mixed factorial controlled design will be employed in which cbt plus standard pharmaceutical care (cbt/sc) is compared to a standard pharmaceutical care (sc) treatment condition. participants will be randomized in equal numbers to the two conditions. repeated assessments of key outcome domains will occur at pretreatment/baseline and at 12, 24 and 36 weeks following baseline. methodology: study participants will be evaluated pre-treatment (baseline), 12 weeks post-baseline (post-treatment) and at 24 and 36 weeks post-baseline (follow-up). baseline assessment will include a neurological examination with a nerve conduction study to confirm the diagnosis of diabetic neuropathy. the primary outcome measure will be pain intensity. secondary outcome measures will be pain quality, pain-related disability, physical and emotional functioning. measures of treatment feasibility will also be examined. participants receiving cbt will attend 10 weekly, group treatment sessions of 90 minutes. a target sample size of approximately 120 participants will be recruited.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * daily lower extremity pain or discomfort (burning, tingling or other parasthesias) for at least 3 months * documented trial of at least one medication for neuropathic pain * pain of at least 4 on a 0-10 numeric rating scale exclusion criteria: * acute medical condition, substance abuse, or psychiatric condition that would impair ability to participate * dementia (mmse score of 23 or lower)

Keywords: diabetes neuropathy chronic pain cognitive behavioral therapy
a novel neurorehabilitation approach for cognitive aging with hiv

Conditions: HIV; Aging

Summary: the goal of this study is to conduct a small, self-contained project to test the hypothesis that tdcs will augment sop cognitive remediation therapy (crt) in older hiv+ adults. the investigators will randomly assign 60 hiv+ older adults (i.e., ≥ 50 years old) to 10-hours in either a sop crt + sham tdcs condition (n=30) or sop crt + active tdcs condition (n=30) and examine neurocognitive functioning at baseline and 6 weeks post-intervention. hypothesis 1: the sop crt + active tdcs condition will show larger proximal (i.e., sop) gains than the sop crt + sham tdcs condition. hypothesis 2: the active tdcs condition will demonstrate generalization to secondary neurocognitive domains compared to the sham tdcs condition.


Eligibility criteria:
inclusion criteria: * hiv+ * aged 50 and older * patient at university hiv/aids clinic exclusion criteria: * not homeless * not blind or deaf * no significant neuromedical issues (e.g., schizophrenia, bipolar disorder, stroke, epilepsy or history of seizures) * no pacemaker or other biomedical devices or metal implants * no untreated hypertension * not undergoing chemo or radiation * no head injury with loc greater than 30 mins

Keywords: tdcs cognitive remediation therapy
load quantitative mri study of incipient lbp patients.

Conditions: Low Back Pain

Summary: the mian purpose of this study is to analysis the imaging changes in 3.0t mri of lumbar small joints, intervertebral discs, ligaments and muscle in hospital nurses first suffered with low back pain.

low back pain is a common clinical disease seriously affects the quality of people's lives. and this disease takes up a large proportion in the crowd. incipient lumbago is hard to diagnose and often hidden morbidity. if early symptoms are ignored by patients, it will greatly influence the quality of life in the future. this study will use 3.0t mri to distinguish the difference of lumbar small joints, intervertebral discs, ligaments and muscle between the normal and the pain. firstly, we recruit nurses with low back pain in one group, with the normal as control. then the subject will accept 3.0t mri scanning at the same time. before scanning we will determine the mri sequence to make sure the imageis are clear enough. at last, we will analysis the photos in the image processing workstation, reconstruct the anatomical structure in the scanning area. all of this is to find a possible reason or explanation in the occurrence of incipient lumbago through the comparison of two group's images.

Eligibility criteria:
inclusion criteria: 1. female between 18 and 27 years of age 2. subject who has worked as a nurse less than three years and will continue working as a nurse no less than one year 3. back pain has happened more than 2 times in the past 12 months(every time lasts 2 days or more),or never happened 4. subjects who do not participate any other study concerning pain prevention currently and in the next year 5. according with magnetic resonance inspection standard 6. no spectical low back pain and no other serious diseases in the other systems exclusion criteria: 1. subjects who has a family history of low back pain 2. subjects who are suffering from specific low back pain 3. subjects who are suffering from serious somatic disease and/or psychic disease 4. subjects who are suffering from chronic pain disease and need long-term use of drug therapy 5. subjects who are pregnant, planning to have a baby in 1 year or less than 6 months after delivery 6. subjects who are suffering from chronic cardiac, respiratory, liver and kidney complaint symptomatically 7. subjects who have had a spinal operation

Keywords: low back pain load quantitative mri