Kornimate/medical-research-clean huggingface dataset:
determining efficacy and safety of bxcl501 in agitation associated with pediatric schizophrenia and bipolar disorder

Conditions: Schizophrenia; Schizo-Affective Disorder; Schizophreniform; Schizophrenic; Bipolar Disorder I; Bipolar Disorder II

Summary: this is a study of the efficacy and safety of bxcl501 in children and adolescents with acute agitation and either bipolar disorder or schizophrenia.

the study will enroll approximately 140 subjects randomized to dose regimens of 80 µg or 120 µg bcxl501 or placebo (group one), or 60 µg bcxl501 or placebo (group two; europe only). subjects with acute agitation will include male and female children and adolescents who are either newly admitted to a hospital setting or already admitted and experiencing acute agitation. subjects will be domiciled in a clinical research setting or hospitalized to remain under medical supervision while undergoing screening procedures to assess eligibility. efficacy and safety assessments will be conducted periodically before and after dosing.

Eligibility criteria:
inclusion criteria: 1. male and female subjects between the ages of 10-17 years, inclusive, with bipolar disorder (dsm-5 criteria) and 13-17 years, inclusive, in subjects with schizophrenia (dsm-5 criteria). 2. patients who are judged to be clinically agitated at screening and baseline with a total score of ≥14 on the 5 items comprising the panss excited component (pec). 3. patients who have a score of ≥ 4 on at least 1 of the 5 items on the pec at baseline. 4. participants who agree to use a medically acceptable and effective birth control method exclusion criteria: 1. patients with agitation caused by acute intoxication, including alcohol or drugs of abuse (with the exception of thc) during urine screening. 2. use of benzodiazepines or other hypnotics or oral or short-acting intramuscular antipsychotic drugs in the 4 hours before study treatment. 3. patients who are judged to be at significant risk of suicide. 4. patients with serious or unstable medical illnesses. 5. patients who have received an investigational drug within 30 days prior to the current agitation episode. 6. patients who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving the study drug.
sleep disturbances and chronic widespread pain

Conditions: Chronic Widespread Pain; Sleep Disturbance

Summary: chronic widespread pain (cwp), defined as long-lasting pain in multiple body regions, has a prevalence of 10-14% in europe and is associated with other physical symptoms such as fatigue and cognitive problems. individuals with longstanding pain also have a high prevalence of sleep disturbances, and sleep problems can in itself lead to tiredness, lower neurocognitive function and higher pain ratings. however, studies of comorbid sleep problems for individuals with cwp are a lacking, and the primary aim for the present study is to assess the prevalence of sleep disturbances in individuals with cwp, and to see how this covariates with pain, fatigue, activity level, neurocognitive functioning, and biomarkers. as a secondary aim the study will assess a subgroup of the individuals, that has received multimodal pain management treatment, a second time after 6 months to analyze how the prevalence of sleep disturbances and other associated problems covaries over time.


Eligibility criteria:
inclusion criteria: * chronic widespread pain exclusion criteria: * other untreated and or serious psychiatric or somatic conditions

Keywords: pain sleep neuropsychology fatigue activity level attention executive function memory
weight gain management in patients with schizophrenia

Conditions: Schizophrenia

Summary: evaluate the efficacy of nizatidine in reducing/limiting weight gain in patients with schizophrenia who have been under treatment with olanzapine for at least two months and evaluate the treatment effects on the eating inventory, bprs, number of treatment, emergent adverse events, changes in vital signs, laboratory results and extrapyramidal effects.


Eligibility criteria:
inclusion criteria: * patients, men or women, with age of 18 to 65 years * patients must have schizophrenia that meets disease diagnostic criteria as defined in dsm-iv sections 295.10, 295.20, 295.30, or 295.90 and not to be in a clinically acute phase, in accordance with the judgment of the investigator * patients in use of 5 mg/day and 20 mg/day of olanzapine for a period not less than 2 months and not greater than 6 months and that have increased at least 5% of their corporal weight since the beginning of the treatment with olanzapine. * the individuals must be trustworthy, and have a level of understanding enough to carry out all the tests and examinations demanded for the protocol, to understand the nature of the study and to have signed the informed consent * women with potential to become pregnant must be using a medically acceptable and reliable means of birth control. exclusion criteria: * participation in a clinical study of another drug in investigation within a period of 1 month (30 days) before the entrance in the study (visit 1) * people who have used clozapine within a period of 12 months before the beginning of the study * people with diagnosis of diabetes mellitus types i or ii without adjusted clinical control or have initiated the medication use for glycemic control in the last 6 months * dsm-iv substance (except nicotine and caffeine) dependence within the past 30 days * current participation in programs of weight loss
reproductibility of tm-mode ultrasound diaphragm measures in patients with acute respiratory distress in the er

Conditions: Respiratory Distress Syndrome, Adult

Summary: the main objective of this study is to evaluate the inter-rater reproducibility of diaphragmatic excursion measures via time-motion-mode ultrasound (evaluation performed on the first measure) in patients experiencing acute respiratory distress emergencies.

the secondary objectives of this study are: * to assess the feasibility of measuring the diaphragmatic excursion in the context of emergency management (ratio of measured patients / included patients). * to evaluate the time required for the measurement. * to assess the intra-rater reproducibility of measurements of diaphragmatic excursion (comparison of first and second measures).

Eligibility criteria:
inclusion criteria: * the patient must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * the patient has acute respiratory distress defined by a respiratory rate \> 25, and / or signs of struggle and hypoxia, oxygen saturation (spo2) \ 6 kpa (45 mm hg) * the patient breathes spontaneously (no respirator) 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, under tutorship or curatorship * the patient or his/her representative refuses to sign the consent * it is impossible to correctly inform the patient, or to correctly inform his/her representative * the patient is pregnant, parturient, or breastfeeding * the patient has a neurological or neuromuscular disease that modifies diaphragm function/movement; this does not include cases of decompensation (polyradiculoneuropathy, lou gehrig's disease, myasthenia ...). * patient admitted with respiratory support treatment in progress * patient admitted with respiratory failure requiring immediate implementation of mechanical ventilation, thus preventing ultrasound measurements

Keywords: diaphragm movement ultrasound emergency room
the effect of oral gabapentin on emergence agitation and delirium in adult patients after nasal surgery.

Conditions: Emergence Agitation

Summary: emergence agitation is a postanesthetic phenomenon that develops in the early phase of recovery from general anesthesia, and is characterized by agitation, disorientation, confusion, and possible violent behavior. emergence agitation can cause serious events such as self-extubation, bleeding, catheter removal and even falling out of the bed leading to severe injuries . furthermore, it may lead to injuries to health care providers and increase the demand on human resources. while its pathogenesis remains unclear, previous studies reported that ent (ear, nose, and throat) surgical procedures have a higher incidence of emergence agitation in both adults and children. emergence agitation is a common phenomenon occurring in 22.2% in adult patients undergoing general anesthesia for nasal surgery . gabapentin, agamma-aminobutyricacidanalog, binds the voltage-gated calcium channels of the dorsal root ganglion, at α2-δ subunite. gabapentin binding to these channels reduces the release of excitatory neurotransmitters preventing the propagation of painful stimuli which makes its use helpful in treatment of postoperative pain and agitation with less side effects compared with benzodiazepines and opioids . gabapentin has been used in controlling acute perioperative conditions like preoperative anxiety, intraoperative attenuation of hemodynamic response to noxious stimuli and post operative pain, delirium and nausea and vomiting. a previous study examined the effect of oral gabapentin 600 mg in reducing emergence agitation in adult patients undergowing rhinoplasty, but this study will examine the effect of two different doses of oral gabapentin 400 mg and 600 mg in reducing emergence agitation after nasal surgery.


Eligibility criteria:
inclusion criteria: * all patients (male/female, american society of anesthesiologists physical status i-ii, age: 18-60 years) undergoing elective nasal surgery will be eligible for the study. exclusion criteria: 1. hypersensitivity to gabapentin 2. patient refusal 3. epilepsy 4. neurological or psychological conditions that impair communication. 5. current use of gabapentin, psychotropic or opioids medications.

Keywords: emergence agitation gabapentin nasal surgery
"metcool acs"- metformin "cooling" effect on metformin-naive patients treated with pci because of acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: the aim of the study is the evaluation of the effect of metformin among the patients without diabetes, on the incidence of reintervention, unplanned revascularization, after full percutaneous coronary revascularization as a result of the first episode of the acute coronary syndrome (acs).


Eligibility criteria:
inclusion criteria: * age \>18 years * acs, according to the current definition of the european society of cardiology, treated with percutaneous coronary intervention with drug eluting stent implantation * occupation and place of residence not causing difficulties in participating in control visits * uncomplicated course of the disease (acs) as assessed by the treating physician * negative history of diabetes * not taking any hypoglycaemic drugs prior to hospitalization immediately or within the last 6 months * hba1c\< 6,5% (assessment during hospitalization) * written consent to participate in the study exclusion criteria: * significant valve disease confirmed by echo * previous cabg * nyha iv during hospitalization * chronic kidney disease with gfr \<60 ml / min / 1.73 m2 according to mdrd * alt three times above normal according to laboratory criteria * serious co-morbidities and estimated survival less than 2.5 years, as assessed by the treating physician * known gastrointestinal disease that may potentially be responsible for the intolerance to metformin (e.g. inflammatory bowel disease, gastro-oesophageal reflux disease) * known potential difficulties in cooperation with patients (dementia, mental disorders, distance from the place of residence, if considered potentially problematic, alcoholism) * hypersensitivity to metformin * pregnancy and breastfeeding * patient participation in another clinical trial
a fineh protein trial - part 1

Conditions: Diabetes Prevention; Obesity Prevention

Summary: the objectives of this trial are to assess the health benefits of acute hemp protein consumption compared to soybean protein and a non-protein control on: 1) blood glucose, appetite and blood pressure for one hour following consumption, 2) food intake at an ad libitum meal one hour following consumption and 3) blood glucose, appetite and blood pressure following the ad libitum meal to determine the "second meal effect" of hemp protein.


Eligibility criteria:
inclusion criteria: * normoglycemic (\<5.6 mmol/l) * body mass index (bmi) of 18.5-29.9 kg/m2 participants will be excluded if they regularly skip breakfast, smoke, or consuming medications that may influence study outcomes or have experienced any gastrointestinal related health conditions/surgeries over the past year. exclusion criteria: * restrained eaters * regularly skip breakfast * smokers * those who are active (organized activities or athletic training at a high intensity; ≥ 150 min per week of moderate to vigorous physical activity) * those on medications that may influence study outcomes or have experienced any gastrointestinal related health conditions/surgeries over the past year.
a study to evaluate the safety of tetravalent rotavirus vaccine in healthy indian adult male volunteers

Conditions: Rotavirus Gastroenteritis

Summary: this is a phase i study to evaluate the safety and tolerability of the tetravalent rota virus vaccine in healthy indian adult male volunteers administered a single dose of the vaccine at the highest possible viral concentration in 0.5 ml of vaccine.


Eligibility criteria:
inclusion criteria: * healthy indian adult male volunteers. * no apparent signs or symptoms of ill health. * properly informed about the study and having signed the informed consent form (icf). in case of the volunteer being unable to read or write, having had the icf explained to them in the presence of a study independent witness and the witness having signed the icf; * subject available for the entire period of the study and reachable by study staff for post-vaccination follow-up. exclusion criteria: * known or suspected impairment of immunological function; * known hypersensitivity to any component of the rotavirus vaccine; * fever, with axillary temperature ≥38.1oc (≥100.5of); measured by study staff. * history of chronic diarrhea; * clinical evidence of active gastrointestinal illness; * receipt of any intramuscular (im), oral, or intravenous (iv) corticosteroid treatment in the past 30 days * subjects suspected to be hiv, hepatitis b virus (hbv) or hepatitis c virus (hcv) positive from the available clinical history * prior receipt of a blood transfusion or blood products, including immunoglobulins; * any subject who cannot be adequately followed for safety; * any conditions which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. * subject unable to maintain diary card

Keywords: safety of vaccine
psychosocial outcomes and transition readiness in jia

Conditions: Juvenile Idiopathic Arthritis

Summary: it is widely acknowledged that the transition from paediatric to adult health services should be a multidimensional and multidisciplinary process that addresses the medical, psychosocial, and educational needs of adolescents and young adults (aya). despite this, there is currently a scarcity of research examining the relationships between psychosocial factors (e.g., anxiety, social support) and transition readiness in aya with juvenile idiopathic arthritis (jia). this study therefore aimed to examine the relationships between psychosocial factors and transition readiness in pre-transfer adolescents and post-transfer young adults aged 10-25 years diagnosed with jia at a single centre. in total, 40 adolescents aged 10-16 years together with a parent/guardian, will take part at sheffield children's hospital and 40 young adults aged 16-25 years will take part at sheffield teaching hospitals. participants will be asked to complete a battery of self-report questionnaire measuring psychosocial factors (anxiety/depression, social support, family functioning, health-related quality of life) and transition readiness (transition knowledge and skills, self-efficacy). jia disease severity was also measured during clinic appointments. this study has received full ethical approval, and all participants will give their written informed assent or consent before taking part. the results from this research will be important in better understanding which psychosocial factors affect how ready young people with jia feel to move from paediatric to adult rheumatology services. we hope this research will inform further work to help target psychological interventions in this group of patients.


Eligibility criteria:
patient inclusion criteria: * aged 10-25 years * diagnosis of juvenile idiopathic arthritis (including all ilar subtypes except 'systemic arthritis' and 'undifferentiated arthritis') * juvenile idiopathic arthritis managed by sheffield children's hospital or sheffield teaching hospitals * fluent in verbal and written english patient exclusion criteria: * aged \ 25 years * diagnosis of juvenile idiopathic arthritis ilar subtypes 'systemic arthritis' or 'undifferentiated arthritis') * diagnosis of uveitis * non-fluent in verbal and written english
investigation of vascular inflammation in migraine using molecular nano-imaging and black blood imaging mri

Conditions: Migraine Headache; Migraine Without Aura

Summary: the investigators aim to investigate inflammation of cranial and meningeal arteries during pharmacologically induced migraine attacks, using ultrasmall superparamagnetic iron oxide (uspio) nanoparticles and black blood imaging (bbi) mri.

migraine is the most common neurological disorder, ranked as the 7th most debilitating disease worldwide by the who. while much research has been and continues to be conducted to illuminate the enigma of migraine pathophysiology, key aspects still remain a conundrum. specifically, the process of headache generation is perhaps the most complex and debated part of migraine pathophysiology. the vascular hypothesis of migraine has traditionally focused on the simple dilatation of cranial arteries. however, a possible contribution of perivascular pain sensitive structures should also be considered, as aseptic inflammation of the arterial walls and perivascular space may activate afferent nerve endings. interestingly, giant cell arteritis caused by aseptic arterial wall inflammation may present clinically as localized headache with migraine-like features (i.e. throbbing pain, localized in the temporal region, and allodynia). the primary trigeminal nociceptor is the first integral part of the headache-generating pathway. animal models of migraine have suggested that activation and sensitization of perivascular trigeminal nociceptors caused by inflammatory substances may explain head pain in migraine. however, there is no human evidence to date to suggest perivascular and arterial wall inflammation as a source of pain in migraine. the investigators hypothesize that unilateral migraine without aura is associated with ipsilateral inflammation of the cranial arteries and meninges. the investigators also suggest that sumatriptan inhibits this perivascular inflammation. to test the hypotheses the investigators will perform mri scans on subjects with provoked migraine attacks, using two different methods to visualize perivascular inflammation: uspio-mri, using iron-oxide nanoparticles as contrast agent, and bbi mri. to pharmacologically induce migraine headache in the study subjects, the investigators will use the drug cilostazol, which is a phosphodiesterase 3 inhibitor.

Eligibility criteria:
inclusion criteria: * written informed consent * subject has migraine without aura according to criteria of the international headache society (ihs) * subject has unilateral migraine 70% of the time * migraine can be pharmacologically provoked in the subject using cilostazol. * subject is on birth control * subject has no other medical history exclusion criteria: * subject suffers from bilateral migraine * subject suffers from migraine with aura * subject suffers from other primary headaches as specified by ihs criteria * pregnant or breast feeding subjects * subjects with contraindications for undergoing mri scans * any known drug allergy * any signs or disorders of iron overload, including but not limited to hemosiderosis and porphyria cutanea tarda
vt ablation in the icmr

Conditions: Ventricular Tachycardia

Summary: the visabl-vt is a prospective, single-arm, multi-center, interventional investigation of the safety and efficacy of radiofrequency (rf) ablation of ventricular tachycardia associated with ischemic cardiomyopathy performed with the vision-mr ablation catheter 2.0 in the icmr environment.


Eligibility criteria:
inclusion criteria: * roll-in subjects only: documentation of premature ventricular contractions indicated for ablation therapy (subjects may or may not be diagnosed with ischemic cardiomyopathy) * documented (ecg/egm) spontaneous episode of sustained ventricular tachycardia within 6 months of the procedure * diagnosis of ischemic cardiomyopathy * aad therapy refractory, contraindicated, not tolerated, or not desired * 18 years or older exclusion criteria: * implanted with non-mr compatible medical devices or contraindicated for an mri * presence of intracardiac thrombus (verified via ct/mri/tee/tte within 48 hours of procedure - or at start of procedure) * thrombocytopenia or coagulopathy * mechanical mitral and/or aortic valve precluding access to the left ventricle * severe aortic stenosis * myocardial infarction requiring stent implantation within 90 days of procedure * previous cardiac surgery within 60 days of procedures * known/uncontrolled stroke risks * class iv heart failure * ejection fraction (ef) \< 25% * patients with a glomerular filtration rate (gfr) \< 30 * women who are pregnant * allergy to contrast agents (e.g., gadolinium) * active infection * known or suspected myxoma * unstable angina * patients who do not tolerate anticoagulation therapy * previous intertribal septal patch or prosthetic atrial septal defect closure device * life expectancy \< 12 months * enrollment in another study without sponsor approval
[18f] facbc and [18f] flt pet imaging in central nervous system tumors

Conditions: Brain Cancer; Gliomas

Summary: the purpose of this study is to help us understand gliomas, one type of brain tumor. this research protocol makes pictures of gliomas. we will take pictures of the glioma before and after treatment. the pictures are made with a positron emission tomography (pet) scanner. pet scans use radioactive markers to "see" cancer cells. we plan to use two different radioactive markers, \[18f\]facbc and \[18f\]flt, to "see" if the glioma responds to the treatment being recommended by the doctor. we are investigating whether one or both of these types of pet scans can help us to better understand gliomas and their response to treatment. we expect these pictures will give us information the your tumor and may help us to understand why the treatment that the patient is receiving is affecting the tumor the way that it is. we also hope to collect information about the amount of radioactivity exposure. we will measure radioactivity exposure to the tumor, brain and other organs.


Eligibility criteria:
inclusion criteria: * registered patient at mskcc. * child-bearing age females must be non-pregnant,(documented by a negative pregnancy test within the last 2 weeks), non-lactating, and must be using adequate contraception or be surgically sterile. * patients with gliomas * patients planning to start anti-akt and/or anti-vegf directed therapies . * patients with measurable disease on mri or ct neuroimaging. exclusion criteria: * patient is incontinent of urine or stool (which would make them unable to tolerate lying still for 60 minutes). * patient cannot tolerate lying still for a 60 minute session in the pet tomograph.

Keywords: 18f-facbc pet scan imaging 08-142