Kornimate/medical-research-clean huggingface dataset:
the second intensive blood pressure reduction in acute cerebral haemorrhage trial

Conditions: Intracerebral Hemorrhage; Stroke; Hypertension

Summary: the purpose of this academic lead study is to determine if a treatment strategy of early intensive blood pressure (bp) lowering compared to conservative bp lowering policy in patients with elevated blood pressure within 6 hours of acute intracerebral haemorrhage (ich) improves the outcome of death and disability at 3 months after onset.

intracerebral haemorrhage (ich) is one of the most serious subtypes of stroke, affecting over a million people worldwide each year, most of whom live in asia. about one third of people with ich die early after onset and the majority of survivors are left with major long-term disability. despite the magnitude of the disease burden and cost on healthcare resources, there remains uncertainty about the role of surgery for ich and no acute medical therapies have been shown to definitely alter outcome in ich. the interact2 study follows the recently completed initial pilot study vanguard phase) which established the feasibility of the protocol, safety of early intensive bp lowering, and effects on haematoma expansion within 6 hours of onset of ich. having established 'proof-of-concept' that bp lowering may improve outcome by reducing haematoma expansion, interact2 aims to establish the effects of the treatment on major clinical endpoints in patients with ich recruited from an expanding clinical network around the world.

Eligibility criteria:
inclusion criteria: * patients with ct-confirmed spontaneous intracerebral haemorrhage (ich) * elevated systolic blood pressure (\>150mmhg and \<220mmhg) * capacity to commence randomly assigned treatment within 6 hours of onset of ich. * able to be 'actively' treated and admitted to a monitored facility exclusion criteria: * clear indication or contraindication to intensive bp lowering. * evidence ich secondary to a structural abnormality * use of thrombolytic agent * previous ischaemic stroke within 30 days * a very high likelihood that the patient will die within the next 24 hours on the basis of clinical and/or radiological criteria * score of 3-5 on the glasgow coma scale (indicating deep coma) * significant pre-stroke disability or advanced dementia * planned early neurological intervention * participation in another clinical trial. * a high likelihood that the patient will not adhere to the study treatment and follow-up regimen.

Keywords: cerebral hemorrhage stroke antihypertensive drugs blood pressure disability clinical trial outcomes
preliminary study on the development and reliability and validity of attention rating scale

Conditions: Depression; Insomnia; Attention Disturbances; Healthy

Summary: this study, based on preliminary experimental results, literature review, and expert consultations, developed the attentional rating scale (ars). the aim was to rapidly assess participants' attention and potential influencing factors. the research focused on the scale's reliability and validity among healthy adults. additionally, the attention network test (ant) served as the gold standard for evaluating attention. the study attempted to identify correlations between various dimensions of attention and the three attentional networks.

1. to adiministrate 60 healthy subjects to evaluate internal consistency reliability. 2. to choose 20 cases for ars retesting 7 days after the first ars evaluation. 3. to evaluate the split half reliability through the spearman brown coefficient. 4. to apply principal component analysis for structural validity analysis. 5. using the attention network test (ant) and toronto hospital alertness test (the) as gold standards, the pearson correlation coefficient was used for criterion validity analysis. 6. to administrate 60 patients with mdd, adhd and insomnia disorder testing the discrimination validity of ars.

Eligibility criteria:
inclusion criteria: 1. major depressive disorder (mdd) or attention deficit hyperactivity disorder (adhd) diagnosed according to dsm-5, or chronic insomnia disorder diagnosed according to icsd-3 2. ages between 18 and 60 years old 3. right-handed 4. educational level ≥5 years or iq ≥90, capable of understanding and reading chinese. exclusion criteria: 1. currently diagnosed with any other dsm-5 mental disorders (according to mini 7.0) or icsd-3 sleep-wake disorders, apart from mdd, adhd or insomnia disorder 2. currently and past history of neurological disorders and physical illnesses with subjectives 3. consumed alcohol in the week preceding the enrollment 4. using antidepressants, antipsychotics, mood stabilizers, or other central nervous system-acting drugs for at least 4 weeks in the current episode 5. undergoing any physical treatments such as ect, neuromodulation therapy or traditional chinese medicine treatment in the past 6 months 6. refused to sign the informed consent form
anatomical and structural connectivity in two psychotic phenotypes : periodic catatonia and cataphasia

Conditions: Schizophrenia; Catatonia

Summary: the different subtypes of schizophrenia might have a disordered connectivity as their final common pathways. the investigators will use multimodal structural mri to assess anatomical connectivity on the one side and its functional consequence on functional connectivity on the other side to assess two phenotypes of psychosis : periodic catatonia and cataphasia in comparison with control subjects. the coherence between structural and functional anomalies will be especially studied.


Eligibility criteria:
inclusion criteria (controls): * aged from 18-65 y * right handed additional inclusion criteria for patients: * schizophrenia according to the dsm5 * either periodic catatonia or cataphasia according to the wkl classification * under stable medication regimen (\> 1m) exclusion criteria: * current substance abuse * contraindication to mri * past records susceptible to affect brain integrity * severe, unstable medical condition * pregnancy * patients deprived of their rights
open label extension safety and efficacy study of tnx-102 sl tablets in military related ptsd and related conditions

Conditions: PTSD

Summary: this is a 12-week, multicenter, open-label extension study to evaluate the safety and efficacy of tnx-102 sl tablet taken daily at bedtime in patients with military-related ptsd or related condition. patients recruited into this trial are those who have successfully completed the double-blind study, tnx-cy-p201 (atease study) \[nct02277704\]. patients will not be made aware of the therapy they received during the double-blind study.

the study will consist of 4 clinic visits, including screening/baseline visit 1 (day 0, which is anticipated to be the same date as the final visit in the lead-in p201 study) and visits after 2, 6 and 12 weeks of treatment. the previous requirements in the lead-in study for refraining from the use of certain concomitant medications and trauma-focused psychotherapies will be relaxed. patients may continue to take rescue therapy for sleep, as appropriate, or they may utilize other medications as needed to help them sleep, per the judgment of the investigator. eligible patients who provide written informed consent will take one tnx-102 sl tablet daily at bedtime sublingually (under the tongue) for 12 weeks. all patients will be assigned to receive tthe same dosage of tnx-102 sl, regardless of their treatment assignment in the lead-in study. no patients, investigators, or study staff will know the assigned study treatment from the lead-in study, p201, at the time of entry into the extension study. patient data collected at the week 12 visit (visit 9) in the lead-in p201 study will be used as one of the baseline values for this study.

Eligibility criteria:
inclusion criteria: * completed the lead-in study and is judged as reasonably compliant, with at least 60% compliance * signed informed consent * met all prior inclusion and exclusion requirements for lead-in study * no new or worsening medical conditions since starting the lead-in study that could pose a safety risk or interfere with participation in the study * willing to refrain from use of specific medication (ask pi) * female patients of childbearing potential continue to practice medically acceptable methods of birth control exclusion criteria: * none

Keywords: ptsd military-related ptsd and other related conditions open-label extension
substrate metabolism and insulin sensitivity in acromegalic patients before and after treatment

Conditions: Acromegaly; Excessive Growth Hormone Secretion; Insulin Resistance

Summary: the purpose of this study is to investigate the effects of chronic elevated growth hormone on metabolism and insulin sensitivity by studying acromegalic patients before and after treatment.


Eligibility criteria:
inclusion criteria: * written consent * age between 18 and 70 * recently diagnosed with acromegaly exclusion criteria: * nyha 3 * uncontrolled hypertension * known cerebrovascular disease * proliferative retinopatia

Keywords: acromegaly growth hormone insulin resistance glucose tolerance body composition substrate metabolism
far forward battlefield telemedicine: evaluation of handheld ultrasound

Conditions: Thoracic Injuries

Summary: the goal of this study is to improve survival of battlefield trauma through ultrasound telemedicine and remotely guided therapeutics.

specific aims to meet to improve the survival of battlefield trauma are 1)validation of portable ultrasound for diagnosis of various medical and surgical emergencies, ie cardiac tamponade, intraabdominal hemorrhage, 2)extension of our expertise in digital echocardiography and local telemedicine to support other centers in such procedures as tee 3)development of wireless telemedicine systems for rapid relay of ultrasonic images from portable ultrasound system to a remote review station. 4)development of a precision guide for diagnostic and therapeutic percutaneous procedures using ultrasound guidance 5)combining wireless telemetry with the guided percutaneous access tool to permit remotely guided emergency procedures 6)augmenting this work(2d/echo) with 3d/echo.

Eligibility criteria:
inclusion criteria: * 18-80 yrs old * scheduled for clinical echocardiogram exclusion criteria: * none

Keywords: trauma portable ultrasound telemedicine department of defense
a study of nasal glucagon (ly900018) in japanese participants with diabetes mellitus

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to determine the efficacy and safety of nasal glucagon compared to intramuscular (im) glucagon for treatment of insulin-induced hypoglycemia in japanese participants with diabetes mellitus.


Eligibility criteria:
inclusion criteria: * participants with type 1 diabetes (t1d) or type 2 diabetes (t2d) * body mass index (bmi) of 18.5 to 30.0 kilograms per meter squared (kg/m2) for t1d, or 18.5 to 35.0 kg/m2 for t2d * hemoglobin a1c (hba1c) ≤10% exclusion criteria: * have significant changes in insulin regimen and/ or unstable blood sugar control within the past 3 month * have received a total daily dose of insulin \>1.2 units per kilogram (u/kg)
tumor gene expression in women with ovarian cancer

Conditions: Ovarian Cancer

Summary: the study objective is to compare changes in expression of glucocorticoid-induced genes that may be involved in cell survival signaling in the tumors of ovarian cancer patients before and after an intraoperative dose of 20mg dexamethasone.

this trial will examine the upregulation of dexamethasone-inducible genes in the tumors of ovarian cancer patients undergoing surgical debulking. a core biopsy of tumor will be taken at the first opportune time during surgery. dexamethasone 20 mg iv will then be administered, and a second biopsy taken 30 minutes later. samples at two and four hours later will also be obtained if surgery is still in progress and biopsiable tumor remains. tissue will be snap-frozen. subsequently tumor will be microdissected out from stroma, and tumor rna will be extracted for gene expression profiling. sixteen patients with epithelial ovarian cancer receiving dexamethasone will be studied, and an additional eight patients with epithelial ovarian cancer will receive a small saline (placebo) injection and serve as controls. enrollment is limited to those patients with a serum albumin of at least 3.0 g/dl to minimize any theoretical adverse effect of a single dose of dexamethasone on wound healing.

Eligibility criteria:
inclusion criteria: * subject has intraabdominal disease either proven or strongly suspected to be ovarian or primary peritoneal cancer, and will be undergoing surgical debulking. * subject is not allergic to dexamethasone, and there is no obvious medical contraindication to dexamethasone. * subjects with diabetes requiring drug therapy are excluded. * subject is not currently receiving glucocorticoid therapy * nasal steroids (e.g. flonase) are permitted * subject understands that this protocol does not have therapeutic intent * preoperative serum albumin at least 3.0 mg/dl * negative serum or urine pregnancy test in women of childbearing potential * signed informed consent exclusion criteria: * males do not get ovarian cancer and therefore will not be included in this trial. * patients of all ethnic backgrounds are eligible and will be encouraged to enroll. however we do not expect differences based on ethnicity, and this small study will not therefore be powered to make conclusions about ethnic differences in induction of gr-regulated genes with dexamethasone.

Keywords: subject has intraabdominal disease either proven or strongly suspected to be ovarian or primary peritoneal cancer
tele nursing application for type 1 diabetes mellitus adolescents

Conditions: Telenursing; Adolescent; Type 1 Diabetes Mellitus

Summary: studies have shown that tele-nursing practice is effective in children with type 1 diabetes mellitus, but the number of studies conducted is very few. no study examining the concepts of metabolic control, self-efficacy, quality of life and anxiety together was found in the literature review. with this study, it is aimed that diabetes education given by tele-nursing has an effect on metabolic control, self-efficacy, quality of life and anxiety level of adolescents with type 1 diabetes, and that diabetic adolescents can easily obtain the information they need about nursing care when they cannot come to the clinic.


Eligibility criteria:
inclusion criteria: inclusion criteria: * the child is between the ages of 12-18, * after the information, the adolescent agrees to participate in the study, and the parent gives written consent, * the child can understand and speak turkish, * parent's ability to understand and speak turkish, * having a smart phone and having access to the internet, * having been diagnosed with t1dm at least 1 year ago, * being on insulin therapy by the subcutaneous route, * coming to the outpatient clinic at least once every 3 months. exclusion criteria: exclusion criteria: * age younger than 12 or older than 18, * having another chronic disease, * using an insulin pump * having vision and hearing problems, * using the continuous glucose tracking system, * having a physical or mental disability.

Keywords: telenursing type 1 diabetes mellitus metabolic control self efficacy quality of life anxiety
observational study for subjects with pompe disease undergoing immune modulation therapies

Conditions: Pompe Disease

Summary: hypothesis: the effectiveness of treatment of pompe disease with rhgaa enzyme replacement therapy (ert) is limited at least in part because patients develop antibodies against the provided rhgaa enzyme. treatment with immunomodulatory drugs may dampen or eliminate the anti-rhgaa immune response in patients receiving ert, thereby allowing for greater ert efficacy. studying the immune response to rhgaa may provide valuable insight into the role of the immune system in the effectiveness of ert for pompe disease.

the purpose of this research study is to determine the effect(s) of medications that alter the immune system on anti-rhgaa immune response in pompe patients receiving rhgaa enzyme replacement therapy (ert). the investigators would also like to determine whether treating pompe disease with medications that affect the immune system has any effects on the overall health or disease progression of pompe. subjects will be patients between the ages of 0 months and 65 years who have been diagnosed with pompe disease, confirmed by mutational analysis and/or gaa enzyme activity assay. subjects will be eligible regardless of whether they have begun enzyme replacement therapy prior to enrollment. all subjects will receive enzyme replacement therapy as standard of care during the course of the study, although they may not have begun ert treatment at the time of enrollment. in addition to ert, subjects may receive an immunomodulatory regimen as part of their standard of care; this may include rituximab, sirolimus, methotrexate, ivig or other immunomodulatory agents such as pharmacological chaperone n-butyldeoxynojirimycin (nb-dnj), alone or in combination, at the discretion of their caregiver(s).

Eligibility criteria:
inclusion criteria: * patients between the ages of 0 months and 65 years * diagnosed with early-onset pompe disease, confirmed by mutational analysis and/or gaa enzyme assay * eligible regardless of whether they have begun enzyme replacement therapy prior to enrollment * all subjects will receive ert as standard of care during the course of the study, although they may not have begun ert treatment at the time of enrollment * subjects may receive an immunomodulatory regimen as part of their standard of care; this may include rituximab, sirolimus, methotrexate, gamunex, hizentra, zavesca or other immunomodulatory agents, alone or in combination, at the discretion of their caregiver(s) exclusion criteria: * subject is unable to meet the study requirements * subjects medical condition contraindicates participation or study investigators feel that participation is otherwise not in the subject's best interest * subject does not receive ert treatment

Keywords: pompe disease infusion associated reaction immune-modulation regimen
zidovudine / lamivudine + nevirapine twice daily, versus tenofovir + lamivudine + nevirapine once daily in arv-naive patients

Conditions: Hiv Infection With Antiretroviral Therapy Indication; CD4 Below 350/µL or Below 15%

Summary: the study will compare the immuno-virological efficacy, and safety, of a once daily antiretroviral combination (tenofovir + lamivudine + nevirapine) versus a twice daily association (fixed dose combination of zidovudine/lamivudine + nevirapine) in arv-naive hiv-1 infected subjects, with cd4 cell count below 350/µl or below 15%, whatever the viral load. pharmacological (nevirapine concentrations) and virologic data (resistance mutations in case of failure) will also be provided, as well as adherence rate and quality of life in respect of the treatment arms.

96-week antiviral efficacy of tenofovir + lamivudine + nevirapine, once daily, versus a reference antiretroviral treatment given twice daily (zidovudine/lamivudine + nevirapine)

Eligibility criteria:
inclusion criteria: * hiv-1 infection, confirmed by a western-blot assay, at least 6 months after primary infection * age \> or equal to 18 years of age * no prior antiretroviral treatment * karnofsky superior to 60% * cd4 t cells \ 250/µl * written informed consent exclusion criteria: * hiv-2 infection or co-infection * prior antiretroviral treatment * intolerance, or contraindication to investigational drugs * pregnant or breast-feeding woman, or plan to become pregnant * active untreated opportunistic infections (aids-defining illness, category c, cdc, 1993), or malignancies requiring cytotoxic chemotherapy * biological criteria: hemoglobin \ 2n, asat or alat \> 2.5n, bilirubin \> 2n, hypophosphatemia * prevision of poor adherence * hbc co-infection (ag hbs positive) or hvc co-infection (positive hcv pcr) * liver failure, alcohol abuse * treatment administration not recommended with investigational drugs * interferon, interleukin, or hiv vaccine treatment * informed consent not obtained

Keywords: antiretroviral therapy nevirapine hiv viral load adherence quality of life resistance mutations
comparison of cadazolid versus vancomycin in children with clostridium difficile-associated diarrhea (cdad)

Conditions: Clostridium Difficile Infection

Summary: cadazolid has demonstrated activity against a bacteria named clostridium difficile in animal studies. the results of a first study conducted in adult patients have suggested efficacy of the new antibiotic, cadazolid, in the treatment of diarrhea caused by this bacteria. this is the first study of cadazolid in children. the overall purpose of this study is to provide reassurance on the safety and efficacy of cadazolid in children suffering from infection due to clostridium difficile.

this multicenter, study will be run into two parts. both parts will be run in consecutive age cohorts, starting from the oldest age categories(12 to \< 18 years old) to the youngest (birth to \< 3 months). * part a is an open-label, dose finding part to be conducted in at least 24 subjects. * part b follows a randomized, assessor-blinded, parallel-group design with vancomycin used as an active comparator. part b will be conducted in about 176 children. in both parts, the treatment period will be 10 days and will be followed by a follow-up period of 28-32 days.

Eligibility criteria:
key inclusion criteria: * signed informed consent by parents or legally authorized representatives (lar) and assent by the child according to local requirements prior to initiation of any study-mandated procedure. * male or female from birth to \< 18 years of age, diagnosed with clostridium difficile-associated diarrhea (cdad). * females of childbearing potential must have a negative pregnancy test at screening and must agree to use an adequate and reliable method of contraception. key exclusion criteria: * positive rotavirus test for subjects \< 5 years. * fulminant or life-threatening cdad. * more than one previous episode of cdad in the 3 month period prior to enrollment / randomization. * antimicrobial treatment active against cdad administered within 24 h prior to screening except for metronidazole treatment failures (mtf). * subjects with body weight \< 3 kg. * inflammatory bowel disease, chronic abdominal pain, or chronic diarrhea of any etiology. * fecal microbiota transplant (fmt), immunoglobulin therapy, or any investigational drug to prevent or treat cdad within 1 month period (or 5 half-lives in case of investigational drug, whichever is longer) prior to enrollment / randomization. * monoclonal antibodies against c. difficile within 6 months prior to enrollment / randomization. * previous vaccination against c. difficile. * known mental disorders. * any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study, or compliance with the protocol.

Keywords: vancomycin children cadazolid clostridium difficile associated diarrhea
digital analysis of primary teeth dimensions in a group of egyptian children (4-6 years)

Conditions: Digital Analysis of Tooth Crown Dimensions of Primary Teeth

Summary: tooth size (mesiodistal, buccolingual and occluso-gingival) has an important role in pediatric dentistry as it helps for fabrication of appropriate sizes of zirconia crowns for primary anterior teeth and stainless-steel crowns for primary posterior teeth. tooth size differs among and within populations.


Eligibility criteria:
inclusion criteria: 1. children aged 4-6 years 2. fully erupted first and second primary molars 3. sound interproximal \& buccal / lingual walls with or without minimal occlusal pits \& fissure incipient caries. 4. no previous interproximal \& buccal / lingual restorations 5. intact mesial and distal marginal ridge exclusion criteria: 1. children with gross carious lesions. 2. children with hypo-mineralization, hypoplasia and fracture. 3. children with mental disability.