Kornimate/medical-research-clean huggingface dataset:
assessment of the behavior of the preterm newborns

Conditions: Premature Birth

Summary: the project presented here aims to evaluate the discrimination capacity of the observation of sensory-motor behavior (osmb) grid of the preterm infant, as well as its predictive capacity for the child's later psychomotor development. to do this, osmb grids will be completed during dystimulant care and during stabilizing care in 65 preterm infants. in addition, an osmb grid will also be completed during a sensorimotor assessment at 37 weeks gestational age and at 1 month corrected for prematurity in 100 preterm infants. the ocsm scores will then be compared to the bayley iii scale scores at 6 months of age corrected for prematurity.

the project presented here aims to evaluate the discrimination capacity of the observation of sensory-motor behavior (osmb) grid of the preterm infant, as well as its predictive capacity for the child's later psychomotor development. to do this, osmb grids will be completed during dystimulant care and during stabilizing care in 65 preterm infants. in addition, an osmb grid will also be completed during a sensorimotor assessment at 37 weeks gestational age and at 1 month corrected for prematurity in 100 preterm infants. the ocsm scores will then be compared to the bayley iii scale scores at 6 months of age corrected for prematurity.

Eligibility criteria:
inclusion criteria: * \<37weeks * hospitalized in geneva hospital nicu * at least one parent speaking french exclusion criteria: * no exclusion cirteria

Keywords: premature birth
pgi2 induced headache and cerebral haemodynamics in healthy volunteers

Conditions: Headache; Migraine

Summary: before , during and after intravenous administration of pgi2 we score/measure headache, rcbf, blood flow in middle cerebral artery and diameter of superficial temporal artery/radial artery and correlate that to known patophysiology of headache to see if pgi2 is involved in headache pathophysiology.


Eligibility criteria:
inclusion criteria: * healthy volunteers, exclusion criteria: * primary headache, * headache on the day of investigation, * hypertension, * hypotension, * pregnant/nursing * daily intake of medication (except oral contraceptives) * cardiovascular or cns disease * drug/alcohol abuse * psychiatric disease
mirna biomarkers in multiple sclerosis

Conditions: Multiple Sclerosis; miRNA; Epigenetic; Biomarker

Summary: multiple sclerosis (ms) characterized by demyelination and axonal degeneration is a chronic inflammatory disease of the central nervous system (cns). recent studies have shown that dysregulated mirnas alter immune responses, so they may have roles basis on various genetic diseases such as ms and may be potential targets for biomarkers and new therapeutic approaches. in this study, we evaluated the dysregulation of mirna expression levels at ms and ms stages. we also discussed the potential of these mirnas to be biomarkers and/or therapeutic targets in ms.


Eligibility criteria:
inclusion criteria: * the age of 25 years and above * at least one central nervous system (cns) demyelination event exclusion criteria: * with genetic diseases, hypertension, head trauma, neuropsychiatric disease, diabetes mellitus, hypertension, cardiac failure, hepatic failure, renal failure, thalassemia, sickle cell disease, iron deficiency, and b12 deficiency

Keywords: multiple sclerosis mirna biomarkers peripheral blood molecular diagnostics
expectations of patients regarding exercise in an outpatient clinic

Conditions: Communcation; Physical Activity; Prescription

Summary: exercise and physical activity are recommended in many clinical guidelines in orthopdeci diseases. costs, time, doctor-patient-communication and the type of prescription are possible limitations of prescribing exercise as a therapy. it is essential to know the expactiations and attitude of the patients for an accurate, patient-centered, prescription. this trial aims to reveal patients point of view and attitude.


Eligibility criteria:
inclusion criteria: * patient presented the first time in the outpatient study with an issue exclusion criteria: * language barrier * cognitive impairment which could lead to missunderstadning of the survey
growth of preterm infants fed a infant milk formula containing high versus low amounts of beta-palmitate

Conditions: Weight Gain

Summary: the aim of this study is to assess weight gain of preterm infants (gestational age lower than 32 weeks) fed infant milk formula with about 60% beta-palmitate (ex_imf) vs infant milk formula with similar macronutrient, mineral and fatty acid composition but lower amounts of beta-palmitate (st_imf). own mother milk (omm) fed infants will serve as reference group.

a large number of low birth weight infants during their hospital stay experience poor growth and this has been linked to reduced neurodevelopment scores. several enriched infant milk formulas are available for preterm infants who cannot be fed human milk. the use of infant milk formulas (imf) enriched with triglycerides similar to human milk lipids have shown to be associated with better fatty acid and mineral intestinal absorption. in this multicenter, randomized, controlled clinical trial, preterm infants (gestational age lower than 32 weeks), who can not be fed human milk, will be randomized to receive imf with high or low amounts of beta-palmitate (about 60% vs 10%, respectively). a non-randomized own human milk-fed group will be included as a reference. patients will be on the study diet as soon as possible after birth and till 36 weeks of gestation. neurodevelopment follow-up will be performed at 24 months corrected age.

Eligibility criteria:
inclusion criteria: * gestational age between 24 and 32 weeks of gestation at enrollment, * birth weight greater than 750 grams, * singleton or twin birth (no triplet or higher), * fraction of inspired oxygen lower than 0.60 at enrollment, * feasible enteral feeding, * cardiovascular stable condition, * informed consent form signed by at least one parent or legal guardian. exclusion criteria: * congenital malformations, genetic, metabolic and endocrine disorders, * suspicious infection at enrollment, * intrauterine growth restriction (\<10th centile) at enrollment, * maternal diabetes requiring insulin therapy, * neonatal asphyxia.

Keywords: growth preterm infants beta-palmitate infant formula human milk
clozapine im and aggression in schizophrenic patients

Conditions: Schizophrenia

Summary: aggressive, persistent aggression and impulsive behavior are frequently observed in schizophrenic patients. according to some researchers "more than 50% of all psychiatric patients and 10% of schizophrenic patients show aggressive symptoms varying from threatening behavior and agitation to assault"(1). it is a common cause of psychiatric admission and is a therapeutic issue. the treatment of these symptoms is a clinical problem for both patients and staff. violent behavior, a major detrimental factor in stigmatization of the mentally ill, also poses physical danger for the patients themselves. current pharmacotherapy of pathologic aggression involves the use of multiple agents (typical and atypical antipsychotics, benzodiazepines, mood stabilizers, beta-blockers, antiandrogenic hormones, and selective serotonin reuptake inhibitors) on empiric basis, with varying degrees of response (2-6). unfortunately, these approaches lead to numerous side effects. poor or noncompliance with pharmacotherapy makes it difficult to choose the appropriate preparation. currently, typical neuroleptics are still the first choice in treating acute aggressive symptoms, while risperidone and olanzapine could be alternatives (5-7). typical depot neuroleptics should be considered in cases where medication compliance is a problem. most clinical information on treating of aggression has been collected about atypical neuroleptics, particularly regarding clozapine. clozapine is indicated in psychotic state and/or in drug-resistant schizophrenic patients. according to the fda - it is the drug of choice in suicidal and aggressive patients, due-to psychotic state. it was found helpful in nearly 30% of resistant schizophrenic patients. concerning the parenteral administration of clozapine - very little data is available today. this study aims to investigate efficacy and safety (psychopathology, and side effects) of parenteral clozapine in treatment of aggressive behavior in schizophrenic patients in a double-blind trial.


Eligibility criteria:
inclusion criteria: * schizophrenic, schizoaffective, or schizophreniform according to dsm-iv * treatment-resistant * presenting pathologic violent-aggressive behavior on admission * at risk for self damage * age: 18-65 * patient is not participating in any other study at time of this study * minimal score of 70 on panss * prior resistance to at least 2 different classes of neuroleptics * oas scores of at least 4 points in physical aggression sections and at least 2 points in verbal aggression section exclusion criteria: * neutropenia or any other abnormal cbc result * myeloproliferative disease * chronic physical diseases such as liver, renal or cardiac diseases * history of alcohol or drug abuse * history of drug induced granulocytopenia/agranulocytosis * alcoholic/drug psychosis or intoxication * carbamazepine or other bone marrow suppressor treatment * uncontrolled epilepsy * paralytic ileus * hypersensitivity to clozapine

Keywords: schizophrenia aggression clozapine efficacy double-blind
a multinational phase iii study of cs-8958 (marvel)

Conditions: Influenza, Human

Summary: the primary objective of this study is to confirm the efficacy of cs-8958 administered as a single inhaled low dose or single inhaled high dose by showing non-inferiority to oseltamivir phosphate using the time to alleviation of influenza illness. for safety evaluation, between-group comparisons will be made with regard to incidence of adverse events and other safety measures. in a secondary objective, the optimum dosage of cs-8958 for this indication will be evaluated based on the efficacy and safety of single inhaled low or high dose.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of influenza * axillary temperature of \> or = to 37.5 degrees c exclusion criteria: * infection by bacteria species and/or virus other than influenza virus * chronic respiratory disease * renal dysfunction

Keywords: influenza neuraminidase inhibitor
endoscopic sleeve gastroplasty with endomina® for the treatment of obesity in kidney transplant candidates

Conditions: Obesity, Morbid; End Stage Renal Disease; Kidney Transplantation; Endoscopic Sleeve Gastroplasty

Summary: the aim of this pilot prospective interventional study is to evaluate the efficacy of endoscopic sleeve gastroplasty (esg) in allowing obese subjects (≥35 kg/m2) with end stage renal disease who need of kidney transplantation to reduce their bmi below 35 in order to be inserted in the waiting list bmi. the main question\[s\] it aims to answer are: is the procedure effective in reducing bmi to the target level in 12 months? which is the effect on weight loss, quality of life and obesity-related comorbidities? participants will undergo esg as per standard clinical practice and followed up to 12 months before transplantation and for 12 months after transplantation.


Eligibility criteria:
inclusion criteria: * adult patients (i.e., age between 18 and 70 years). * bmi ≥ 35 kg/m²; * patients with chronic kidney disease (ckd) g4-g5 (glomerular filtration rate \[gfr\] \<30ml/min/1.73 m2) who are expected to reach end-stage kidney disease (eskd) at least 6 to 12 months before anticipated dialysis initiation (pre-emptive transplant candidates) or patients already on haemodialysis when medically stable and kidney failure deemed irreversible; * patients not listed because of a high bmi according to the policy of the transplant centre (cut-off 35 kg/m2); * signed informed consent. exclusion criteria: * patients on peritoneal dialysis * upper gastro-intestinal bleeding (gastric or oesophageal) in the previous six months; * ongoing or active malignancy during the last 5 years * myocardial infarction during the past 6 months or/and heart failure class iii or iv according to the new york heart association's classification; * previous stomach, oesophagus or duodenum surgery; * technical non-feasibility in the opinion of the endoscopist; * clinical signs of active infection; * concomitant unstoppable anticoagulant or anti platelet therapy, except for low dose aspirin (≤ 100 mg); * active drugs or alcohol abuse; * pregnancy, lactation (desire to become pregnant during study duration); * enrolment in other clinical studies; * contraindication to general anaesthesia; * other conditions to exclude the subject in investigators opinion; * refusal to sign informed consent. -
comparative effectiveness of copd treatments

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: to assess the effectiveness of maintenance treatment of chronic obstructive pulmonary disease (copd) with the combination of a long-acting bronchodilators (laba and the long-acting muscarinic antagonists (lama) tiotropium (laba-tio)) compared with the combination of a laba and an ics (laba-ics) on the time to copd exacerbation.


Eligibility criteria:
inclusion criteria: * new users of long-acting bronchodilators, laba and tiotropium on the same date or of laba and ics, either as a fixed-dose combination or free combination, on the same date between january 2002 and december 2015 * diagnosis of copd and age ≥ 55 years exclusion criteria: * less than one year of medical history information prior to the date of combined treatment initiation (cohort entry) * asthma diagnosis
observational study of the therapeutic study of recombinant hiv-1 tat

Conditions: HIV Infection

Summary: the results of the phase i safety and immunogenicity trial of recombinant hiv-1 tat (iss p-001 and iss t-001) indicate that the vaccine based on the recombinant tat protein is safe, well tolerated and immunogenic. the present study is intended to extend the follow-up of the volunteers for additional 3 years to evaluate the persistence of the anti-tat humoral and cellular immune responses. the results of the present study will be key for the design of future phase ii trials, particularly for the definition of the optimal schedule for boosting immunizations. all individuals (27) will be enrolled in a 120-weeks observational study and monitored every 24 weeks for the following 3 years. during these visits, which are performed within the schedule indicated for the clinical monitoring of hiv-1 infected individuals, in addition to the routine virological, hematological and biochemical assessment, the anti-tat specific humoral and cellular immune responses will be evaluated.


Eligibility criteria:
inclusion criteria: * previous participation to the phase i clinical trial iss t-001

Keywords: hiv tat protein
mindfulness-based cognitive therapy for individuals with multiple chemical sensitivity

Conditions: Multiple Chemical Sensitivity

Summary: the objective of this study is to evaluate the effect of mindfulness-based cognitive therapy (mbct) on physical symptoms attributed to chemical exposures, psychological distress, illness worry, quality of life, and illness perceptions in patients suffering from multiple chemical sensitivity (mcs). furthermore, a secondary objective is to evaluate whether a possible symptom reduction is mediated by an increased level of mindfulness. the primary hypothesis is that the self-reported severity of mcs symptoms and the degree to which chemical exposures causes symptoms and the impact on daily life will be significantly improved in the mbct treatment group as compared to the control group.


Eligibility criteria:
inclusion criteria: * fulfil lacour's criteria for multiple chemical sensitivity * sign a written informed consent form exclusion criteria: * a psychotic or bipolar disorder * an acute psychiatric disorder requiring other treatment * suicidal ideations * current alcohol or drug abuse * previously engaged in a mindfulness programme

Keywords: multiple chemical sensitivities mcs mindfulness-based cognitive therapy mbct
treatment of cheyne stocks respiration with adaptive servo ventilation and bilevel ventilators in patients with chronic heart failure

Conditions: Heart Failure; Sleep Apnea

Summary: the overall purpose of this study is to determine the effects of adaptive servo ventilation (asv) and bi-level ventilators on cheyne-stocks respiration (csr). csr is a pattern of breathing characterized by hyperpneas followed by hypopneas and or apneas. clinically, the physiologic changes translate to sleep fragmentation, excessive daytime sleepiness, reduced exercise capacity and possibly ventricular arrhythmias. the intent of the proposed intervention is to compare the efficacies of asv and bi-level ventilator on csr.


Eligibility criteria:
inclusion criteria: 1. patient or legal representative of the patient is willing and able to sign an irb/mec approved informed consent and privacy protection authorization in the united states 2. subject is \> 18 years old 3. patients with known history of csr. csr symptoms may include the following: * sleep fragmentation as reported by patient or as witnessed by another person * night arousal after apneic episodes * reduced exercise capacity * daytime sleepiness 4. expected to tolerate the ventilator therapy exclusion criteria: 1. baseline oxygen saturation \< 90% on a stable fio2) 2. patient is currently enrolled in another clinical study which may confound the results of this study 3. patient for whom informed consent cannot be obtained 4. patient who is of pregnant or of child bearing potential without a negative pregnancy test within 10 days of the study procedure 5. patients implanted with unable to tolerate inactive pacemaker, implantable defibrillator or cardiac resynchronization device for duration of testing procedure - approximately 8 hours (e.g. pacemaker dependency) 6. patients with severe copd (per gold scale) 7. patients with a history of myocardial infarction within the 6 months prior to the study 8. patients with unstable angina

Keywords: cheyne stocks respiration heart failure sleep apnea ventilator
effect of cequa™ in subjects with dry eye disease

Conditions: Dry Eye Disease

Summary: this is a phase 4, multicenter, single arm, 12 week study in subjects with dry eye disease, which is inadequately controlled by cyclosporine 0.05% ophthalmic emulsion.

this is a phase 4, multicenter, open-label, single-arm, 12-week study of subjects with dry eye disease that is inadequately controlled by cyclosporine (csa) 0.05% ophthalmic emulsion. subject enrollment will be classified by evidence of dry eye disease (ie, signs, symptoms, or both signs and symptoms). treatment will be one drop of csa 0.09% ophthalmic solution (cequa) in each eye twice daily (bid) for 12 weeks. the study hypothesis is that csa 0.09% ophthalmic solution will show improved clinical benefit in subjects whose dry eye signs and/or symptoms are inadequately controlled while on csa.

Eligibility criteria:
inclusion criteria: 1. male or female subjects with a history of bilateral dry eye disease for a period of at least 3 months. 2. aged of at least 18 years. 3. subjects with total corneal fluorescein staining ≥6 or corneal fluorescein staining in an individual zone ≥2 as per national eye institute grading scale. 4. subjects with modified symptom assessment in dry eye global symptom score, ≥40 using visual analogue scale. 5. subjects with best-corrected visual acuity 20/200 or better in both eyes at the screening/baseline visit exclusion criteria: 1. subjects who have used cyclosporin 0.05% ophthalmic emulsion in both eyes for less than 3 months prior to the screening/baseline visit. 2. subjects with history of treatment failure with cyclosporin 0.05% ophthalmic emulsion. 3. subjects who have active seasonal and/or perennial allergic conjunctivitis in either eye. 4. subjects who had already use initiated any systemic or topical ocular medication.

Keywords: keratoconjunctivitis sicca kcs dry eye
a study of azd0486 plus rituximab in previously untreated follicular lymphoma patients

Conditions: Untreated Follicular Lymphoma

Summary: this is a global, randomised, phase iii, multicentre, open-label study evaluating the efficacy, safety and the degree of added benefit of the azd0486 plus rituximab combination compared to investigator's choice of 3 standard immunochemotherapy regimen, conducted in participants with untreated fl.

the study consists of 2 sequential parts. 1. safety run-in - this part will compare dose levels of azd0486 in combination with rituximab in order to establish the rp3d. 2. phase iii - the phase iii part will assess the superiority of azd0486 at rp3d in combination with rituximab, compared to investigator's choice between 3 standard chemoimmunotherapy regimens. phase 3 consists of 3 arms 1. arm a: treatment with azd0486 plus rituximab schedule a 2. arm b: treatment with azd0486 plus rituximab schedule b 3. arm c (comparator arm): one of the following standard regimens per investigator's choice: r-cvp + rituximab maintenance, r-chop + rituximab maintenance and b-r

Eligibility criteria:
inclusion criteria: 1. participant must be at least 18 years of age, inclusive, at the time of signing the icf. 2. histologically confirmed diagnosis of fl grades 1-3a per who 2016 classification 3. ecog performance status of 0 to 2 4. no prior systemic lymphoma-directed therapy 5. need for systemic treatment meeting at least 1 gelf criteria 6. fdg-avid and measurable disease 7. adequate liver, hematological, renal and cardiac function. the above is a summary, other inclusion criteria details may apply exclusion criteria: 1. follicular lymphoma grade 3b (who 2016 classification) or suspicion for histologic transformation to high-grade/aggressive lymphoma 2. contra-indication to br, rcvp, and r-chop 3. participants with or history of cns lymphoma 4. presence of \>5000 circulating lymphoma cells 5. active or uncontrolled infection requiring systemic therapy and which places participant at unacceptable risk if he/she were to participate in the study the above is a summary, other exclusion criteria details may apply

Keywords: follicular lymphoma
tibial fracture - platelet-rich plasma and bone marrow concentrate

Conditions: Unilateral Tibial Diaphyseal Fracture

Summary: a prospective, randomised study is to investigate the feasibility of conducting a superiority randomised controlled trial comparing the application of combined autologous prp and concentrated autologous bone marrow (prp-bma) in addition to standard of care (either reamed intramedullary nailing or fine wire ring external fixator) for patients presenting with fresh tibial diaphyseal fractures.


Eligibility criteria:
inclusion criteria: * aged 18-65, skeletally mature adults. * acute unilateral closed tibia diaphyseal fractures as the primary injury. * definitive fracture fixation with reamed intramedullary nailing (statically locked) or fine wire ring external fixator to be performed within 14 days from the date of injury. * willing and able (in the opinion of the study team) to provide informed consent and participate in all study activities. exclusion criteria: * open/compound tibial fracture. * fracture type 42-c2 according to muller ao classification. * multi-segmental nature of this fracture (more than one fracture site within tibia for intervention.) * polytrauma (defined as injury severity score of 17 or more.) * prior or concomitant illnesses that may affect healing. * exposure to drugs that can affect the bone metabolic state within the past three months. * receiving chemotherapy, radiation treatment or immunosuppression drugs. * currently enrolled in any other study which may impact on the results of the present study. * if female: pregnancy, breast-feeding, not currently using and not willing to use an effective form of contraception for 12 months post-surgery.