Kornimate/medical-research-clean huggingface dataset:
study of biib092 in participants with progressive supranuclear palsy

Conditions: Supranuclear Palsy, Progressive

Summary: the primary objective of the study is to evaluate the efficacy of biib092, compared to placebo, as measured by a change from baseline in the psp rating scale (psprs) at week 52 and to assess the safety and tolerability of biib092, relative to placebo, by measuring the frequency of deaths, saes, aes leading to discontinuation, and grade 3 \& 4 laboratory abnormalities. the secondary objective of the study is to evaluate the efficacy of biib092, compared to placebo, as measured by a change in baseline in the movement disorder society (mds)-sponsored revision of the unified parkinson's disease rating scale (mds-updrs) part ii at week 52, to evaluate the efficacy of biib092, compared to placebo, as measured by the clinical global impression of change (cgi-c) at week 52, to evaluate the efficacy of biib092, compared to placebo, as measured by a change in baseline in the repeatable battery for the assessment of neuropsychological disease severity (rbans) at week 52 and to assess the impact of biib092 on quality of life, relative to placebo, as measured by change from baseline on the progressive supranuclear palsy quality of life scale (psp-qol) at week 52.

this study, previously posted by bristol-myers squibb, has transitioned to biogen under a licensing agreement.

Eligibility criteria:
key inclusion criteria: * participants with probable or possible psp * able to ambulate independently or with assistance * able to tolerate mri * have reliable caregiver to accompany participant to all study visits * score greater or equal to 20 on the mini mental state exam (mmse) at screening * participant must reside outside a skilled nursing facility or dementia care facility at the time of screening and admission to such a facility must not be planned key exclusion criteria: * presence of other significant neurological or psychiatric disorders * diagnosis of amyotrophic lateral sclerosis (als) or other motor neuron disease * history of early, prominent rapid eye movement (rem) sleep behavior disorder * history of or screening brain mri scan indicative of significant abnormality * known history of serum or plasma progranulin level less than one standard deviation below the normal patient mean for the laboratory performing the assay note: other protocol defined inclusion/exclusion criteria may apply
efficacy and safety of everolimus (rad001) compared to placebo in patients with advanced neuroendocrine tumors

Conditions: Advanced Neuroendocrine Tumors of Pancreatic Origin

Summary: the purpose of this study was to evaluate progression free survival in those participants assigned everolimus 10 mg/day plus best supportive care versus those assigned to placebo plus best supportive care in advanced neuroendocrine tumors of pancreatic origin.


Eligibility criteria:
inclusion criteria: 1. patients must have advanced (unresectable or metastatic) biopsy-proven pancreatic net 2. measurable disease by radiologic assessment 3. adequate blood work 4. performance status 0-2 : ability to be out of bed most of the time 5. adult male or female patients ≥ 18 years of age 6. women of childbearing potential must have a negative serum pregnancy test 7. written informed consent from patients must be obtained in accordance to local guidelines exclusion criteria: 1. patients with severe kind of (poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small cell carcinoma) cancer are not eligible 2. other chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to starting this trial 3. hepatic artery procedure called embolization within the last 6 months (1 month if there are other sites of measurable disease), or cryoablation/ radiofrequency ablation of hepatic metastasis within 2 months of enrollment 4. prior therapy with the same kind of medication (mtor inhibitors: sirolimus, temsirolimus, everolimus). 5. uncontrolled diabetes mellitus patients who have any severe and/or uncontrolled medical conditions such as: 6. patients receiving chronic treatment with corticosteroids or another immunosuppressive agent 7. patients with a known history of hiv seropositivity 8. no other prior or concurrent cancer at the time enrolling to this trial other protocol defined inclusion/ exclusion criteria applied

Keywords: phase iii advanced neuroendocrine tumor in adults rad001 net everolimus mtor islet cell neuroendocrine
double versus single pledget nasal anesthesia for transnasal endoscopy

Conditions: Anesthesia; Epistaxis

Summary: unsedated ultrathin transnasal esophago-gastro-duodenoscopy (ut-egd), in comparison with conventional peroral egd (p-egd) has been shown to be more tolerable, safer, cost-effective and time-efficient. the investigators and in other studies have showed that nasal pledgetting (or commonly termed nasal packing) is better than nasal spray in terms of patient tolerance and visual capacity. although pledgetting method to a selected meatus can achieve better decongestion effect, epistaxis and nasal pain in some patients are still frustrating to endoscopists. the investigator has proposed a novel meatus scoring scale to evaluate nasal insertability by anterior rhinoscopy using a transnasal endoscope. the investigator also suggest endoscopic-guided gauze pledgetting can provide precise nasal anesthesia, thereby reducing trauma/bleeding in the nasal cavity and increasing patient tolerance during transnasal endoscopy. endoscopic guidance to deliver a gauze strip can confirm delivering it to at least the posterior end of a turbinate. we hypothesize that by using endoscopic-guided method, gauze pledgetting to both the inferior nasal meatus (inm) and middle nasal meatus (mnm) simultaneously is more tolerable than only gauze pledgetting to a single meatus.

nasal anesthesia is the rate-limiting step for a well tolerable unsedated transnasal esophago-gastro-duodenoscopy (ut-egd) procedure. the investigator has proposed that a simple endoscopic-guided gauze pledgetting method (eggp) is more tolerable than the "blind" cotton-tippled applicator method to deliver a gauze strip for anesthetizing the nasal cavity. the initial idea of eggp is to anesthetize only one single selected meatus. to compare patient tolerance, safety and adverse events between double pledget (dpna, i.e. inm and mnm) versus single pledget (spna, i.e. inm or mnm) methods of nasal anesthesia, the investigator is going to conduct a prospective randomized-controlled trial. the rationale for using double pledget is threefold: (1) the middle meatus is bounded by the int and mnt; (2) the inserting and exserting meatuses may be different; (3) erective spongy tissue is mainly distributed in the inferior and middle turbinates and the nasal septum. therefore, the primary objective of this study is to evaluate whether dpna is more tolerable and safer than dpna before ut-egd.

Eligibility criteria:
inclusion criteria: all outpatients with epigastric discomfort (non-ulcer dyspepsia), aged 18-65 years are eligibility for this study. exclusion criteria: * patients who can not answer questionnaires, who have prior nasal trauma or surgery, recent or present upper gastrointestinal bleeding and coagulopathy are excluded from this study. * patients who are allergic to lidocaine and who have uncontrolled hypertension or coronary artery disease are not recruited.

Keywords: nasal anesthesia endoscopes transnasal endoscopy
effect of diving and aquatic exercises on muscle spasticity and motor function in children with spastic cerebral palsy

Conditions: Diving; Aquatic; Muscle Spasticity; Motor Function; Children; Spastic Cerebral Palsy

Summary: this study aims to evaluate the effect of diving and aquatic exercises on muscle spasticity and motor function in children with spastic cerebral palsy.

cerebral palsy (cp) is a common neurological disorders that affect movement and muscle coordination in childhood. hydrotherapy is one of the most popular supplementary treatments for children with neuro-motor impairments, particularly children with cp. hydrotherapy may be more suitable for children with cp because of the properties of water, and it may be more motivating for children than land-based exercise. buoyancy makes it easier for children with moderate to severe mobility limitations to move in the water than to move and exercise on land.

Eligibility criteria:
inclusion criteria: * age from 2 to 5 years. * both sexes. * children diagnosed with spastic cerebral palsy, categorized according to the gross motor function classification system (gmfcs) levels iv, v. exclusion criteria: * botulinum toxin treatment or surgery in the preceding three months. * botox injections before or during the application of the program. * dorsal rhizotomy.
evaluating the pharmacokinetic interaction between ad-2071 and ad-2072

Conditions: Hyperlipidemias; Hypertension

Summary: the purpose of this study is to evaluate the pharmacokinetic interaction between ad-2071 and ad-2072 in healthy male volunteers.

to evaluate the pharmacokinetic interaction, safety and tolerability of the combination compared with the administration of ad-2071 and ad-2072.

Eligibility criteria:
inclusion criteria: * healthy male between 19 and 50 years of age at the time of screening * weight between 50 kg and 90 kg and body mass index (bmi) between 18.0 kg/m2 and 27.0 kg/m2 exclusion criteria: * clinically significant disease or history of clinically significant disease such as liver, kidney, nervous system, respiratory, endocrine\*hematologic, cardiovascular, urinary, psychiatric * gastrointestinal problem or history of gastrointestinal problem and history of gastrointestinal surgery * hdl values less than 35 mg/dl * ast, alt values over than 1.5 times of uln at screening * a person who has a history of drug abuse or who has positive result for an abuse drug in a urine screening test
ectopic pregnancy biomarkers

Conditions: Ectopic Pregnancy

Summary: in an attempt to simplify the diagnosis of ectopic pregnancy, the researchers will investigate the presence of specific molecular markers of ectopic pregnancy. the quantification of these (and other proteins) will be performed using the ciphergen protein chip system where serum is sampled with a high-throughput system. the patterns of these peaks will be compared for those with a diagnosis of ectopic pregnancy and normal pregnancy. later goals of the research will be to identify the actual proteins that correspond to the peaks which discriminate between the two clinical entitles. the goal is to identify a unique protein pattern or protein peak to distinguish a normal intrauterine pregnancy from that of an ectopic implanted gestation.


Eligibility criteria:
inclusion criteria: * reproductive-aged women * currently pregnant based on serum human chorionic gonadotropin level * present for care for pregnancy due to vaginal bleeding and/or pelvic cramping * final diagnosis of one of the following: 1. live intrauterine pregnancy through 14 weeks, diagnosed by ultrasound demonstrating fetal heart motion 2. diagnosed ectopic pregnancy 3. ultrasound confirmation of a nonviable gestation (less 14 weeks) such as an anembryonic gestation or a fetal demise exclusion criteria: * none

Keywords: ectopic pregnancy
effectiveness of combining erector spinea block with non opioid infusions as opioid free anesthesia in spine surgeries.

Conditions: Opioid Use; Spine Fusion

Summary: opioid free anesthesia consists of combination of pharmacological and non pharmacological modalities that target different pathways of pain mechanism. combining myofascial plane blocks with infusion of adjuvants such as lidocaine or dexmedetomidine can offer equivalent intraoperative hemodynamic stability compared to that of opioid with better pain control postoperatively. this study will investigate the efficacy of combined erector spina block with lidocaine and dexmedetomidine infusion as opioid sparing anesthesia in spine surgeries

patients who will undergo spine surgery will be allocated into two groups. after general anesthesia, bilateral erector spine block will be applied in both groups. group a will have intraoperative fentanyl infusion and group b will have lidocaine and dexmedetomidine infusion in 50 ml syringe till end of surgery

Eligibility criteria:
inclusion criteria: - spine surgery asai,ii exclusion criteria: * revision surgery hypotension bradycardia

Keywords: multimodal analgesia, regional blocks, spine surgeries
rtms over the dorsolateral prefrontal cortex for the treatment of impulse control disorders in parkinson's disease

Conditions: Impulse Control Disorder; Parkinson Disease

Summary: this study's objective is to evaluate the effects of repetitive transcranial magnetic stimulation (rtms) over the dorsolateral prefrontal cortex (dlpfc) of patients with parkinson's disease (pd) who experience impulse control disorders (icds) on impulse control symptoms and cognitive behaviors linked to icds: reinforcement learning and delay-discounting. this is a randomized sham-controlled cross-over trial. all patients will undergo a session of active rtms and a session of sham rtms, with the order of sessions randomized across participants. following recruitment and eligibility screening, the eligible participants will undergo two sessions of rtms (active and sham), immediately followed by neurocognitive tasks and questionnaires, no more than 1-2 weeks apart. each session will have a duration of approximately 1-1.5 hours.


Eligibility criteria:
inclusion criteria: * clinician-confirmed diagnosis of pd * ability to provide informed consent, written and verbal * clinician-diagnosed impulse control disorder or impulse control behaviors including punding/hobbyism and dopamine dysregulation syndrome * a beck depression inventory (bdi) (beck et al., 1961) score of 14 or lower * a montreal cognitive assessment (moca) (nasreddine et al., 2005) score of 20 or higher * on dopamine-replacement therapy exclusion criteria: * history of seizures or epilepsy * history of brain lesions (such as multiple sclerosis, tumor) reported * history of vascular issues in the brain, such as stroke * history of a moderate to severe traumatic brain injury * meeting the criteria for a major psychiatric illness such as schizophrenia or depression (bdi score of 14 or higher). * having significant cognitive impairment (assessed by moca, cutoff score of 20) (nasreddine, et al., 2005) * having had tms done in the recent past (within a year) * pregnancy assessed in female patients * intracranial metallic objects (except for dental fillings) * current use of substances or medications known to significantly reduce seizure threshold.
multidomain intervention via a none-face-to-face platform in mild cognitive impairment

Conditions: Mild Cognitive Impairment

Summary: this study will be done to investigate the feasibility and effectiveness of a 24-week multidomain intervention program consisting of cognitive training, exercise, nutrition management, vascular disease risk factor management, and motivational enhancement on the cognitive function via none-face-to-face platform in mild cognitive impairment.

the physical exercise program will consist of aerobic exercise, exercise to enhance balance and flexibility, muscle-strengthening activities involving major muscle groups, and finger-toe movements. cognitive training targets the cognitive domains of episodic memory, executive function, attention, working memory, calculation, and visuospatial function. cognitive training will be conducted using a tablet-based application. participants will be advised to eat something according to the recommendation of the mediterranean-dash intervention for neurodegenerative delay diet (mind) diet. they will be educated about vascular risk factor management every 2 weeks. the purpose of the motivational enhancement program is to induce, maintain, and strengthen motivation, which is a psychological resource to help maintain dementia prevention activities. all intervention will be administered via tablet personal computer (pc) application at home.

Eligibility criteria:
inclusion criteria: * subjects who completed end-of-study evaluation and participated in the preceding randomized controlled trial (rct) "multidomain interventions via face-to-face and video communication platforms in mild cognitive impairment". * being able to use the tablet pc through education, or having a person who can help a participant use the tablet pc. * having a reliable informant who could provide investigators with the requested information * provide written informed consent exclusion criteria: * major psychiatric illness such as major depressive disorders * dementia * other neurodegenerative disease (e.g., parkinson's disease) * malignancy within 5 years * cardiac stent or revascularization within 1 year * serious or unstable symptomatic cardiovascular disease * other serious or unstable medical disease such as acute or severe asthma, active gastric ulcer, severe liver disease, or severe renal disease * severe loss of vision, hearing, or communicative disability * any conditions preventing cooperation as judged by the study physician * significant laboratory abnormality that may result in cognitive impairment * illiteracy * unable to participate in exercise program safely * coincident participation in any other intervention trial
healthy living through personalized monitoring of eyelid care

Conditions: Dry Eye

Summary: portable usb-powered eyemasks provide convenience to dry eye sufferers to perform eyelid warming at home. such eyemasks can be plugged into a copyrighted device developed in collaboration with ngee ann polytechnic that tracks patients' usage. this revolutionary device transmits a signal and is sent to a cloud system whenever the device is used and activity of usage will be recorded. the cloud database only allows access to administrator and will be password protected. you or your physician can monitor the frequency of eyelid warming over a long period.

dry eye is a very common condition that can cause blurring of vision associated with reading, grittiness, eyelid heaviness and poor tolerance of light. up to 80% of dry eye is due to blocked oil glands in the eyelids known as meibomian gland dysfunction (mgd) and scientific studies have shown that sustained eyelid warming at 40-42°c for at least 8 minutes a day is effective to control this condition and increase the tear film layer thickness. portable usb-powered eyemasks provide convenience to dry eye sufferers to perform eyelid warming at home. such eyemasks can be plugged into a copyrighted device developed in collaboration with ngee ann polytechnic that tracks patients' usage. this revolutionary device transmits a signal and is sent to a cloud system whenever the device is used and activity of usage will be recorded. the cloud database only allows access to administrator and will be password protected. you or your physician can monitor the frequency of eyelid warming over a long period. to further encourage eyelid warming to be performed more frequently, the signal can also be sent to a participating games server which hastens progress in the game. thus, addiction to online games, which usually worsens symptoms of dry eye can now be a way to treat dry eye.

Eligibility criteria:
inclusion criteria: 1. subjects must be 21 years or older. 2. subject must have severe mgd 3. subject must be willing to answer the questions in the questionnaire 4. subject must be willing to use the usb-powered eyemask as instructed 5. subject must have the ability to provide informed consent 6. subject must be willing to come back for follow-up visit exclusion criteria: 1. any other specified reason as determined by the clinical investigator. 2. is pregnant, lactating or planning a pregnancy.

Keywords: usb eyemask
determination of walking, balance, fall risk and kinesiophobia in individulas with alzheimer's dementation

Conditions: Alzheimer Disease

Summary: the objective of the researchers is to determine walking, balance, fall risk and kinesiophobia in individuals with alzheimer's dementation.

the gait, balance, fall risks and kinesiophobia of individuals with alzheimer's dementia will be evaluated and compared with healthy individuals.

Eligibility criteria:
inclusion criteria: * independent walker diagnosed with alzheimer's dementia exclusion criteria: * having a disability to do physical activity those who have had an operation in the last 6 months
glucose-dependent insulinotropic polypeptide - new role as blood glucose stabilizer?

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to determine whether glucose-dependent insulinotropic polypeptide (gip) has a stabilizing function on the blood glucose

the aim of the study is to investigate the effect of gip on the glucagon secretion during hyper-, eu- and hypoglycemia in healthy volunteers, patients with type 1 diabetes mellitus and patients with type 2 diabetes mellitus. from this, we will evaluate gip's role as blood sugar stabilizer.

Eligibility criteria:
inclusion criteria: * caucasians with t1dm (diagnosed according to who's criteria) without residual beta cell function (arginine test without increase in c-peptide) in treatment with long acting insulin or * caucasians with non-insulin treated t2dm (diagnosed according to who's criteria) or * caucasians without first degree relative with diabetes mellitus, with normal fasting plasma glucose and glucose tolerance along with negative islet and gad-65 autoantibodies and * normal hemoglobin * informed consent exclusion criteria: * unwillingness to participate or the wish to leave the present study * hba1c \> 9 % * liver disease (alat or asat \> 2 times normal value) * diabetic nephropathy (serum creatinin \> 130 microm and/or albuminury) * proliferative diabetic retinopathy (anamnetic) * atherosclerotic heart disease or heart failure (nyha group iii and iv) * anemia * treatment with medicine which cannot be paused for 12 hours * pregnancy and/or breast feeding * fasting plasma glucose \> 15 mm on the day of the experiment

Keywords: t1dm t2dm gip glucose-dependent insulinotropic polypeptide incretin