Kornimate/medical-research-clean huggingface dataset:
feasibility of transcranial focused ultrasound to measure brain tumor

Conditions: Cranial Neurosurgery

Summary: transcranial focused ultrasound (tfus) offers a platform for non-invasive imaging and treatment of the brain and pathology of the brain -- allowing high resolution imaging in both spatial and temporal dimensions. compared with the gold- standard for brain imaging, magnetic resonance imaging (mri), ultrasound offers reduced contrast while providing improved sampling in time through a significantly more cost-effective approach. in addition, while mri is used to guide invasive treatments, only ultrasound can offer treatments through three primary mechanisms: 1) neuromodulation, 2) blood brain barrier modulation, and thermal/mechanical ablation through high intensity focused ultrasound (hifu). all three treatment options require targeting therapy through the skull, which remains a barrier to clinical translation. this proposal is to test the feasibility of acquiring noninvasive targeting imaging intraoperatively prior to clinically indicated cranial neurosurgery. by acquiring volumetric ultrasound images while coregistered to previously obtained stereotactic magnetic resonance imaging, the study will be able to compare the ability of tfus to identify and focus on brain pathology.


Eligibility criteria:
inclusion criteria: * able to undergo informed consent * scheduled and present for brain surgery * general anesthesia planned * neuronavigation used for surgery * thin cut post-contrast imaging available for coregistration * at least 18 years of age exclusion criteria: * awake craniotomy planned * unhealed wounds or infection of scalp * diseases and conditions that would increase the morbidity and mortality of craniotomy and tumor resection (e.g. cardiopulmonary issues) in the opinion of the pi. * pregnancy (also generally required for surgery)
microinterventional endocapsular nuclear fragmentation assisted cataract surgery

Conditions: Nuclear Cataract

Summary: rationale: in cataract surgery, fragmentation of a hard nucleus requires relatively much ultrasound energy. it is suspected that the level of energy used is associated with the degree of corneal endothelial loss. recently, it was demonstrated that with miloop (zeiss meditec) assisted nuclear fragmentation ultrasound energy can be substantially reduced. objective: to compare miloop assisted cataract surgery and conventional surgery with respect to the energy needed for phacoemulsification and loss of corneal endothelial cells. study design: randomized, controlled trial. study population: patients with nuclear cataract of a grade ≥ 5. intervention: microinterventional endocapsular nuclear fragmentation. main study parameters: cumulative dispersed ultrasound energy (cde) and endothelial cell loss.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * informed consent. * advanced visually significant nuclear sclerosis grade ≥ 5 (locs iii). exclusion criteria: * endothelial cell density (ecd) \< 1500 mm-2. * corneal opacification (any cause). * corneal surgery or trauma. * implant lens. * refraction surgery. * prior glaucoma surgery. * pseudoexfoliation.

Keywords: locs iii grade 5 or more
a study in healthy male subjects designed to assess the mass balance recovery and pharmacokinetics of 14c tzp-101

Conditions: Postoperative Ileus

Summary: a study to investigate the mass balance recovery and pharmacokinetics of 14c tzp-101.


Eligibility criteria:
inclusion criteria: * healthy males * 35-65 years of age * body mass index (bmi) of 18-32 kg/m2 or, if outside the range, considered not clinically significant by the investigator * body weight of 75-90kg * must be willing and able to communicate and participate in the whole study * must provide written informed consent * subject must agree to use adequate methods of contraception exclusion criteria: * participation in a clinical research study within the previous 3 moths or more than 3 studies within the previous 12 months * participation in an ade study within the previous 12 months * history of any drug or alcohol abuse in the past 2 years * regular alcohol consumption \>21 units per week * current smokers and those who have smoked within the last 12 months, or a breath carbon monoxide (co) reading of greater than 10ppm at screening * radiation exposure from clinical studies, including that from the present study, excluding background radiation including diagnostic x-rays and other medical exposures, exceeding 5 msv in the last twelve months or 10 msv in the last 5 years. no occupationally exposed worker, as defined in the ionising radiation regulations 1999, shall participate in the study * clinically significant abnormal biochemistry, haematology or urinalysis at screening as judged by the investigator * clinically significant abnormal physical findings, ecg or vital signs measurements at screening * pr interval 220 ms at screening or on admission * qtcb \>450 ms at screening or on admission * existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism or excretion of the imp * history or presence of significant cardiovascular, respiratory, gastrointestinal (especially peptic ulcer disease), neurological, psychiatric, metabolic, hepatic or renal problems as judged by the investigator * positive drugs of abuse test result * positive hbv, hcv or hiv results * use of prescription or non prescription drugs, including vitamins, herbal and dietary supplements (including st. john's wort) within 14 days of the planned imp administration unless in the opinion of the pi the medication will not interfere with study procedures or compromise study safety * serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients * presence or history of allergy requiring treatment (seasonal allergic rhinitis (hayfever) is allowed unless it is active) * donation or loss of greater than 400 ml of blood within the previous three months * subjects receiving or requiring prohibited medication as described in section 11 * failure to satisfy the investigator of fitness to participate for any other reason * poor venous access
development of a bioabsorbable medical device for the prevention of postoperative intra-uterine adhesions.

Conditions: Infertility; Abortion, Spontaneous; Embryo Implantation, Delayed

Summary: the main objective of this study is to describe the level of expression of the biological factors involved in the formation of adhesions (transforming growth factor beta, activin a, inhibin) at the time of a first diagnostic hysteroscopy among women with synechia, another intracavitary disease or no intracavitary disease.

the secondary obectives are: a. for women who are found to have synechia or another intracavitary pathology at the time of resection: to describe the levels of transforming growth factor beta, activin a and inhibin involved in synechia at the time of resection. b. for women who are found to have synechia or another intracavitary pathology at the time of resection:to describe the levels of transforming growth factor beta, activin a and inhibin involved in synechia at the time of a follow-up hysteroscopy following resection. c. for women who are found to have synechia at the time of resection:to describe the change in levels of transforming growth factor beta, activin a and inhibin involved at the time of a follow-up hysteroscopy following resection whether or not the patient converts back to "no synechia". d. for women who are found to have another intracavitary pathology at the time of resection: to describe the change in levels of transforming growth factor beta, activin a and inhibin involved at the time of a follow-up hysteroscopy following resection whether or not the patient converts to "synechia". e. to estimate the intra-individual variation in the measured factors (initial biopsy levels versus levels at time of resection). f. to create an intrauterine map of factor levels according to biopy position (riosteal / medium / proximal) for patients with synechia or another intracavitary pathology at the time of resection and then follow-up hysteroscopy. g. to describe the levels of transforming growth factor beta, activin a and inhibin as a function of pregnancy 6 months after resection. h. create a tissue bank associated with the study.

Eligibility criteria:
inclusion criteria: * the patient must be given free and informed consent and must have signed the consent form * the patient must be affiliated with or beneficiary of a health insurance plan * indication for hysteroscopy associated with one of the following: infertility evaluation, postoperative dysmenorrhea, embryo implantation failure after invitro fertilization, recurrent miscarriages exclusion criteria: * the patient is participating in another study * the patient is in an exclusion period determined by a previous study * the patient is under judicial protection, guardianship or curatorship * the patient refuses to sign the consent * it is not possible to correctly inform the patient * the patient is postmenopausal * indication of hysteroscopy not associated with exploration of infertility or dysmenorrhea * presence of endometritis objectified via sampling during diagnostic hysteroscopy
a study to evaluate the pharmacokinetics of act-541468 in subjects with mild, moderate, and severe hepatic impairment

Conditions: Hepatic Impairment

Summary: this is a prospective, single-center, open-label, single-dose, phase 1 study, to assess the effect of mild, moderate, and severe hepatic impairment due to liver cirrhosis on the pharmacokinetics of act-541468.


Eligibility criteria:
inclusion criteria: * signed informed consent prior to any study-mandated procedure. * male and female subjects aged between 18 and 75 years (inclusive) at screening. * women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on day -1. they must consistently and correctly use (from screening, during the entire study, and for at least one month after last study treatment intake) a highly effective method of contraception, be sexually inactive, or have a vasectomized partner. * women of non-childbearing potential. * body mass index of 18.0 to 35.0 kg/m2 (inclusive) at screening. * for healthy subjects: normal renal function confirmed by a creatinine clearance at screening according to cockroft and gault adjusted to age of: 1. ≥ 80 ml/min/1.73 m2 for subjects ≤ 50 years of age. 2. ≥ 70 ml/min/1.73 m2 for subjects 51-60 years of age. 3. ≥ 60 ml/min/1.73 m2 for subjects 61-75 years of age. * for subjects with hepatic impairment: degree of liver function impairment due to liver cirrhosis according to the child-pugh classification: 1. group a: mild hepatic impairment, child-pugh score 5-6. 2. group b: moderate hepatic impairment, child-pugh score 7-9. 3. group c: severe hepatic impairment, child-pugh score 10-15. exclusion criteria: * any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol. * for subjects with hepatic impairment: history of major medical or surgical disorders, which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment except for those related to liver cirrhosis (appendectomy and herniotomy allowed, cholecystectomy not allowed). * for healthy subjects: 1. history of alcoholism or drug abuse within the 3-year period prior to screening. 2. relevant history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.
safety and efficacy study of paliperidone extended release (er) among thai schizophrenia participants

Conditions: Schizophrenia

Summary: the purpose of this study is to evaluate the effectiveness and safety of paliperidone extended release (er) treatment in thai schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) participants.

this is an open-label (all people know the identity of the intervention), non-randomized (the study drug is not assigned by chance) study to evaluate the efficacy and safety of paliperidone er in adult thai schizophrenia participants. the study consists of a screening phase and an open-label treatment phase. study duration will be 10 weeks and participants can either be inpatient or outpatient. the recommended paliperidone er starting and maintenance dose will be 6 milligram (mg) per day for most participants. throughout the study, flexible dosing ranging from 3 to 12 mg per day may be used at the discretion of the investigator. throughout the study, participants will be evaluated for efficacy using clinician rating (clinical and global impressions-severity \[cgi-s\] scale, and personal and social performance scale \[psp\]) scales. safety of the participants will be monitored.

Eligibility criteria:
inclusion criteria: * meet the diagnostic and statistical manual of mental disorders (dsm-iv) criteria for schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) * participants unsatisfied with their previous treatment * previously or currently on oral atypical antipsychotics exclusion criteria: * serious unstable medical condition, including recent and present clinically relevant laboratory abnormalities * history or current symptoms of tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body) * history of neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness) * pregnant or breast-feeding female * participation in an investigational drug trial within 30 days prior to selection

Keywords: schizophrenia paliperidone extended release (er) invega
trial assessing long term use of pcsk9 inhibition in subjects with genetic ldl disorders

Conditions: Severe Familial Hypercholesterolemia

Summary: a study to assess the long term safety and tolerability of evolocumab (amg 145) in adolescents and adults with severe familial hypercholesterolemia.

this phase 2/3 open-label extension study was designed to characterize the safety and tolerability of long-term administration of evolocumab to adults and adolescents with severe fh (hofh or non-hofh severe fh). participants not on lipid apheresis at enrollment or within the prior 8 weeks initiated treatment with evolocumab 420 mg once monthly (qm). participants on lipid apheresis at enrollment initiated treatment with evolocumab 420 mg once every 2 weeks (q2w). dose frequency changes (420 mg qm vs 420 mg q2w) were permitted at week 12, 24, or other visits with sponsor approval. participants with \< 5% ldl-c reduction from baseline and serum unbound proprotein convertase subtilisin/kexin type 9 (pcsk9) \< 100 ng/ml could discontinue evolocumab. if serum unbound pcsk9 was ≥ 100 ng/ml with qm dosing, the participant could switch to evolocumab 420 mg q2w treatment. participants on apheresis with ≥ 5% ldl-c reduction from baseline and serum unbound pcsk9 \< 100 ng/ml with q2w treatment could switch to qm dosing. participants were to continue to receive open-label evolocumab for up to 5 years or until evolocumab became commercially available in the relevant patient population, whichever occurred first.

Eligibility criteria:
inclusion criteria: - participated in study 20110233 (nct01588496) or another qualifying evolocumab parent protocol and have a diagnosis of familial hypercholesterolemia. or * have a diagnosis of familial hypercholesterolemia and * males and females ≥ 12 to ≤ 80 years of age * stable low-fat diet and lipid-lowering therapies for at least 4 weeks * low-density lipoprotein cholesterol (ldl-c) \>= 130 mg/dl (3.4 mmol/l) for subjects without diagnosed coronary heart disease (chd)/chd risk equivalent or ldl-c \>= 100 mg/dl (2.6 mmol/l) for subjects with diagnosed chd or chd risk equivalent or apheresis patients have no ldl-c entry requirement * fasting triglycerides ≤ 400 mg/dl(4.5 mmol/l) * body weight of \> 40 kg or greater at screening for subjects less than 18 years of age exclusion criteria: * new york heart failure association (nyha) class iii or iv or last known left ventricular ejection fraction \< 30% * myocardial infarction, unstable angina, percutaneous coronary intervention (pci), coronary artery bypass graft (cabg) or stroke within 3 months of screening * planned cardiac surgery or revascularization * uncontrolled cardiac arrhythmia * uncontrolled hypertension

Keywords: hypercholesterolemia elevated cholesterol high cholesterol homozygous familial hypercholesterolemia pcsk9 mutations severe familial hypercholesterolemia
the partner ii trial: placement of aortic transcatheter valves - pii b

Conditions: Severe; Symptomatic; Calcific Aortic Stenosis

Summary: the purpose of this study is to determine the safety and effectiveness of the sapien xt™ thv with the associated delivery system for inoperable patients with severe symptomatic native aortic stenosis.

cohort b was a 1:1 randomized, controlled study independently powered to compare transcatheter heart valve therapy with the first generation (sapien™ thv) system to transcatheter heart valve therapy with the second generation (sapien xt thv) system in patients who could not undergo surgery (inoperable). patients in the control arm of cohort b received an edwards sapien thv with the associated delivery system while patients in the treatment arm of cohort b received an edwards sapien xt thv with the associated delivery system.

Eligibility criteria:
inclusion criteria 1. patient was symptomatic from his/her aortic valve stenosis, as demonstrated by nyha functional class ii or greater. 2. the probability of death or serious, irreversible morbidity is greater than or equal to 50%. 3. the heart team agreed (and verified in the case review process) that valve implantation would likely benefit the patient. 4. the study patient or the study patient's legal representative was informed of the nature of the study, agreed to its provisions and had provided written informed consent as approved by the institutional review board (irb) of the respective clinical site. 5. the study patient agreed to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which was conducted as a phone follow-up. exclusion criteria 1. aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified. 2. significant aortic disease, including marked tortuosity (hyperacute bend), aortic arch atheroma \[especially if thick (\> 5 mm), protruding or ulcerated\] or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta. (transfemoral) 3. currently participating in an investigational drug or another device study. note: trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials. 4. it is known that the patient is currently enrolled in the partner i trial or was withdrawn from the partner i trial prior to endpoint analysis. 5. active bacterial endocarditis within 6 months (180 days) of procedure.

Keywords: sapien tavr thv aortic stenosis heart valve disease aortic valve retroflex sapien xt
effect of transcranial direct current stimulation (tdcs) on appetite control related brain regions

Conditions: Obesity

Summary: the purpose of this study is to investigate the effect of transcranial direct current stimulation (tdcs) on appetite control related brain regions.

transcranial direct current stimulation (tdcs) is emerging tool for brain modulation in a variety of clinical conditions. in addition, recent neuroimaging studies suggest that modifying the activity of brain circuits involved in eating behavior could provide therapeutic benefits in obesity. the investigators aim to assess whether modulation of the dorsolateral prefrontal cortex (dlfpc) using tdcs, modifies behavioral response and brain activity while watching visually presented food cues in obese subjects. subjects will receive tdcs two times, one is active stimulation and the other is sham stimulation. both stimulations will be separated at least one week and the order of sham and active tdcs will be counterbalanced across subjects. subjects will perform functional mri experiments with visual food cues. questionnaire with behavior measures, body compositions, blood tests will be performed.

Eligibility criteria:
inclusion criteria: * bmi \> 28 kg/m2 exclusion criteria: * history of brain trauma, epilepsy, or other neurological problems
effects of exercise training on mechanoreflex and metaboreflex control in heart failure patients

Conditions: Heart Failure

Summary: the investigators hypothesize that exercise training would improve the mechanoreflex and metaboreflex control in heart failure patients.


Eligibility criteria:
inclusion criteria: * patients with systolic heart failure; * new york heart association (nyha) class ii-iii; * left ventricular ejection fraction less than 40%; * peak oxygen consumption less than 20 ml/kg/min; * stable clinical status. exclusion criteria: * chronic obstructive pulmonary disease; * neuromuscular diseases; * orthopedic diseases; * neurologic diseases; * neoplastic diseases; * recent myocardial infarction or cardiac surgery (less than 6 months); * unstable angina pectoris; * atrial fibrillation; * pacemakers users; * changing medication or hospital admission.