Kornimate/medical-research-clean huggingface dataset:
phase ii study to evaluate conventional radiation therapy followed by radiosurgical boost in clinically localized prostate cancer

Conditions: Prostate Cancer

Summary: this phase ii study designed to prospectively evaluate the efficacy and morbidity of imrt with cyberknife radiosurgical boosts for clinically localized prostate cancer. patients will be treated with three radiosurgical treatments (6.5 gy per fraction) followed by imrt (45 gy in 25 fractions).

this is a phase ii study designed to prospectively evaluate the efficacy and morbidity of imrt with cyberknife radiosurgical boosts for clinically localized prostate cancer. patients with clinically localized prostate cancer will be treated with three radiosurgical treatments (6.5 gy per fraction to the ptv) followed by imrt (45 gy in 25 fractions). treatment will be completed over a 6-7 week period. the hypothesis is that for patients with clinically localized adenocarcinoma of the prostate, cyberknife radiosurgery delivered to the prostate is efficacious with acceptable toxicity in combination with imrt. subjects will have toxicity evaluation and aua score on the last day of treatment. at 1 month following treatment, subjects will be assessed for acute toxicity and will fill out aua form, sf-12, epic-26, shim and utilization of sexual rx/devices. at 3, 6, 12, 18 and 24 month intervals (and every 6 months thereafter, through year 5, and annually through year 10, if investigators opt to continue past year 5), subjects will be seen and evaluated, including a history, physical exam, performance status, psa, toxicity evaluation, and aua score. in addition, at 6 months, 12 months and annually thereafter, the sf-12, epic-26, shim and utilization of sexual medications/devices will be administered. a prostate biopsy will be performed at time of biochemical or local clinical failure, and is encouraged at 2 years following treatment and at time of distant failure. a bone scan will be performed at the time of biochemical failure, or when the subject develops signs of symptoms suggesting metastatic disease. acute side effects (≤ 90 days of treatment start) will be assessed using the nci toxicity criteria version 3.0.

Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the prostate (biopsy within one year of enrollment) * signed study-specific consent * psa within 60 days of registration * baseline aua score is less than 20 exclusion criteria: * prior pelvic radiotherapy * prior radical prostate surgery * recent (within 5 years) or concurrent cancers other than non-melanoma skin cancer * medical or psychiatric illness that would interfere with treatment or follow-up * implanted hardware adjacent to the prostate that would prohibit appropriate treatment planning and/or treatment delivery.

Keywords: prostate cancer
assessment of csf shunt flow with thermal measurements a

Conditions: Hydrocephalus

Summary: this study evaluates the performance of a non-invasive thermal measurement device for assessing csf shunt flow. patients with an existing implanted shunt and symptoms of shunt malfunction will be evaluated with the study device.

patients with an existing implanted ventriculoperitoneal (vp) shunt and who are experiencing shunt malfunction symptoms will be recruited by the clinical investigators at each investigational site in accordance with the inclusion and exclusion criteria. assessment of shunt flow will be performed non-invasively with the study device; physician and clinical staff will be blinded to the device result. standard-of-care assessment of shunt function will be performed and surgical intervention will occur based on the judgement of the treating neurosurgeon without the use of study device data. this trial will evaluate the ability of the study device to identify shunt malfunctions.

Eligibility criteria:
inclusion criteria: * existing ventriculoperitoneal csf shunt * at least one symptom of shunt malfunction as determined by the investigator, including seizure, fever, headache, vision problems, dizziness, disorientation, confusion, vomiting, lethargy, irritability, difficulty waking or staying awake, swelling along shunt tract, enlargement of head, loss of balance, gait disturbance, and loss of sensory or motor function * suspicion of shunt obstruction warrants the performance of a test for this condition in the investigator's judgement * region of intact skin overlying an unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device * available for follow-up for up to fourteen days * signed informed consent by patient or a parent, legal guardian, health care agent, or legally authorized representative. * verbal assent by minors four years of age and older who are able to understand the study and communicate their decision exclusion criteria: * presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt with suspected obstruction * use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed * presence of an interfering open wound or edema over any portion of the shunt * patient-reported history of adverse skin reactions to adhesives * investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable * participation in the study will interfere with, or be detrimental to, administration of optimal health-care to the subject * prior enrollment in this study (multiple enrollments of the same patient are disallowed) * participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study
home-based ssp on individuals with pws

Conditions: Prader-Willi Syndrome

Summary: the polyvagal theory focuses on how function and structure changed in the vertebrate autonomic nervous system during evolution. the theory is named for the vagus, a major cranial nerve that regulates bodily state. as a function of evolution, humans and other mammals have a "new" vagal pathway that links the regulation of bodily state to the control of the muscles of the face and head including the middle ear muscles. these pathways regulating body state, facial gesture, listening (i.e., middle ear muscles), and vocal communication collectively function as a social engagement system (ses). because the social engagement system is an integrated system, interventions influencing one component of this system (e.g., middle ear muscles) may impact on the other components. individuals with prader-willi syndrome (pws) exhibit many behaviors that are consistent with a compromised social engagement system. atypical function of the social engagement system results in problems associated with state regulation (e.g., impulsivity, tantrums, and difficulty with change in routine), ingestion (e.g., difficulties in sucking at birth, hyperphagia), coordination of suck/swallow/breathe, intonation of vocalizations, auditory processing and hypersensitivity, and socialization. the investigatiors propose to confirm that several features of the behavioral phenotype of pws may be explained within the context of a dysfunctional ses, which may be partially rehabilitated via an intervention designed as a 'neural exercise' of the ses (i.e., the safe and sound protocol, "ssp"). specific aims: aim i: to demonstrate the effectiveness of the safe and sound protocol (ssp) on improvement of social and regulation behaviors in individuals with pws. aim ii: to evaluate a new methodology for collecting and evaluating vocal samples for analyses of prosody, one of the indices of the functioning of the ses.


Eligibility criteria:
inclusion criteria: 1. child participants must meet criteria for prader-willi syndrome (per parent membership in prader-willi parent support group). 2. child participants must be between ages 3-17 years. parent must be 18 years or older. 3. child participants must have normal hearing (confirmed via parental report on qualtrics questionnaire) exclusion criteria: 1) child participants who are hearing-impaired (without correction)

Keywords: polyvagal theory social behavior hyperacusis prosody auditory intervention
ologen® collagen matrix in patients with primary congenital glaucoma undergoing trabeculectomy

Conditions: Primary Congenital Glaucoma; Developmental Glaucoma; Infantile Glaucoma

Summary: to the best of investigator knowledge, no studies to this date have compared the safety and efficacy of ologen® collagen matrix in primary congenital glaucoma (pcg) patients undergoing trabeculectomy. given that filtration surgery is usually less successful in patients with developmental glaucoma; the purpose of this study is to compare combined trabeculectomy with trabeculotomy (ctt) with adjuvant ologen® collagen matrix versus ctt without ologen® in children with pcg. investigator hypothesis is that ctt with ologen® collagen matrix would be as effective as ctt in iop control, but with reduced scarring and long term healthier bleb morphology.

standard combined trabeculectomy with trabeculotomy (ctt) all ctt surgeries will be performed under general anesthesia.under aseptic surgical technique, a superior rectus suture will be placed using 4'0 silk and a limbal-based conjunctival flap to be performed. sub-tenon dissection and hemostasis will be achieved and a half-thickness 4 x 4mm rectangular scleralflap will to be dissected up to clear cornea, and radial incision will be placed at the location of the schemes canal, harms trabepculotome will be used to pass into the schemes canal and rotated into the anterior chamber to open app 60 degree on either sides, a 2 × 2 mm deep scleral block will be excised and peripheral iridectomy will be performed. the scleral flap will be closed with one 10-0 nylon suture and conjunctiva will be closed with 8-0 vicryl continuous suture. the same procedure will be done for the ctt with ologen® except, before closing the conjunctiva, the ologen® implant will be placed subconjunctivally just overlapping the apex of the triangular scleral flap ologen® collagen matrix ologen® collagen matrix approved by indian health authority with registration numberof md-1517 (valid till mar-15-2018) will be provided by aeon ajanta india pvt. ltd. free of cost for this clinical research only.

Eligibility criteria:
inclusion criteria: * age between 1 month to 3 years (inclusive) * any case diagnosed as congenital glaucoma (with enlarged corneal diameter more than 11 mm, including corneal edema or haab'sstria with or without optic disc cupping, iop\>12 mm hg) * parents of the patientis willing and able to comply with study procedures and sign informed consent exclusion criteria: * patients withany other types of secondary glaucoma * patients with any other ocular disease
a comparison of two protocol for maxillary molar intrusion buccal miniscrew and tpa versus vertical holding appliance

Conditions: Dental Intrusion; Mandibular Rotation; ANB , SNA, SNB; Openbite Teeth &#X7C; Teeth and Gum &#X7C; Dental

Summary: this study is to compare the dental and skeletal changes caused by the intrusion of maxillary first molars buccal miniscrew and tpa versus vertical holding appliance using lateral cephalometry.


Eligibility criteria:
inclusion criteria: * patients suffering class i or ii with aob. * aob ranged between 3-7 mm assessed from cephalometry. * patients with excess in posterior dentoalveolar height according to burrstone . * patients with good oral hygiene and general health. * patients with no previous orthodontic treatment. * good quality of lateral cephalometry. exclusion criteria: * skeletal open bite * previous orthodontic treatment

Keywords: tpa miniscrew intrusion vertical holding appliance cephalometry
vitamin-d insufficiency and implants

Conditions: Vitamin D Deficiency; Osseointegration Failure of Dental Implant; Peri-Implantitis

Summary: vitamin d is important for bone health, immune function, and inflammation, along with dental implant success. the study aimed to assess bone markers and cytokine levels in patients with and without vitamin d insufficiency to better understand the effects of vitamin d levels on dental implant integration. the study included 42 patients in 2 groups; with insufficient (group in-s; n=21) and sufficient (group s; n=21) levels of vitamin d. bone remodelling, proinflammatory and antiinflammatory markers were analyzed in bone and peri-implant crevicular fluid (picf) using enzyme-linked immunosorbent assay (elisa) and results were reported as concentration and total amount.

background: vitamin d is crucial for bone mineralization and plays a significant role in immune and inflammatory responses. its deficiency is highly prevalent and might alter osseointegration of dental implants. since successful osseointegration is a critical aspect of implant survival and the effects of vitamin d on implant osseointegration have not been well documented, the aim of this study was to evaluate bone markers and cytokine levels of patients with or without vitamin d insufficiency. methods: a total of 42 patients were included and divided into two groups: vitamin d insufficient (group in-s; n=21) and vitamin d sufficient (group s; n=21). besides clinical periodontal parameters and implant stability measurements, bone and peri-implant crevicular fluid (picf) levels of receptor activator of nuclear factor kappa b ligand (rankl), osteoprotegerin (opg), osteocalcin (oc), calcium (ca), tumour necrosis factor alpha (tnf-α), interleukin 1β (il-1β), caspase-1 and interleukin 10 (il-10) were determined by enzyme-linked immunosorbent assay (elisa). results were represented as concentration and total amount.

Eligibility criteria:
inclusion criteria: being volunteer to participate in the study, for the vitamin d sufficient group (group s) having a vitamin d level \>20 ng/ml; and 12-20 ng/ml for vitamin d insufficient group (groups in-s). having sufficient bone height and width at the edentulous areas, not having a systemic disease that may adversely affect osseointegration, not smoking maintaining oral hygiene exclusion criteria: vitamin d deficient patients (\<12 ng/ml), already using vitamin d supplements presence of any systemic disease, such as uncontrolled diabetes, that may affect implant success, smoking, presence of untreated periodontitis, previous exposure to radiotherapy in the head and neck area, presence of osteoporosis or other metabolic bone diseases, usage of oral/intravenous bisphosphonates, history of bone grafting and/or sinus lift, long-term corticosteroid usage.

Keywords: rankl calcium il-10 vitamin d osseointegration
observation of change in clinical global impression scores in schizophrenia patients receiving seroquel xr treatment

Conditions: Schizophrenia

Summary: the purpose of this study is to assess severity of illness in schizophrenia patients in routine clinical practice at the time of entry in the study and after the treatment with seroquel xr for 8 weeks. please note: seroquel sr and seroquel xr refer to the same formulation. the sr designation was changed to xr after consultation with fda.


Eligibility criteria:
inclusion criteria: * adult patients with schizophrenia prescribed on seroquel xr according to the approved product information before inclusion in this non-interventional study * signed and dated patient informed consent (icf) exclusion criteria: * hypersensitivity to the active substance or to any of the excipients of seroquel xr

Keywords: schizophrenia seroquel xr cgi
bone mass accrual in adolescent athletes

Conditions: Amenorrhea; Bone Loss

Summary: the adolescent and young adult years are a critical window in time for bone mineral accrual. more than 90% of peak bone mass is achieved by 18 years, and data indicate that insults sustained during adolescence and young adulthood may result in permanent deficits in bone accrual. adult athletes with amenorrhea (aa) have low bone mineral density (bmd) secondary to hypogonadism, associated with increased fracture risk and associated co-morbidities. we will examine whether estrogen replacement will increase bmd and improve measures of bone microarchitecture in adolescents and young women with aa, thus optimizing peak bone mass.

young female athletes 18-21 years old will be randomized to estrogen (and progesterone) with lifestyle modification versus lifestyle modification alone for a 12 month period. bone density and structure will be assessed over this period. hormonal evaluations will also be performed.

Eligibility criteria:
inclusion criteria: * female * 18-21 years of age * hypothalamic amenorrhea * greater than or equal to 15 years bone age * bmi between 10th-90th percentiles for age exclusion criteria: * use of medications affecting bone metabolism including estrogen/ progesterone, anabolic steroids and glucocorticoids except local application of glucocorticoid creams (washout period of three months necessary prior to study enrollment if medically permissible to discontinue these) * presence of anorexia nervosa or %ibw of \< 85% based on the 50th %ile of bmi for age * spine bmd z-score \< -3 * conditions other than endurance training that may cause amenorrhea including pcos (clinical or preceding laboratory evidence of hyperandrogenism with amenorrhea) * conditions other than endurance training that may cause bone metabolism to be affected * abnormal tsh, elevated fsh, hematocrit \< 30% * pregnancy for girls with aa (to be randomized to estrogen and progesterone or no treatment) * history of migraines, hypertension, allergy to peanut oil, undiagnosed abnormal genital bleeding, known, suspected or history of breast or genital cancer or estrogen dependent neoplasia, known hypersensitivity to progesterone or estrogen or other product ingredients, liver dysfunction or disease * lfts greater than 1.5 times the upper limit of normal * family history or personal history of conditions that may increase risk of thromboembolism: 1. family history of myocardial infarction or strokes occurring at less than 50 years 2. family history of clotting disorders: normal coagulation profile will be necessary for enrollment * history of smoking \>10 cigarettes a day (history of smoking \>14 cigarettes a day is a contraindication for estrogen, but we will be more conservative in our exclusion criteria) * personal history of blood clots

Keywords: amenorrhea athletes bone loss eumenorrhea
cooling pillow for atopic dermatitis

Conditions: Atopic Dermatitis; Eczema

Summary: the purpose of this study is to see if using a cooling pillow at night will help sleep quality in people with atopic dermatitis (ad).


Eligibility criteria:
inclusion criteria: * diagnosis of ad by dermatologist * ad located on the head and neck * investigator global assessment (iga)score \>3 at time of enrollment * able to read, write, and understand study materials * age 18 or older exclusion criteria: * concurrent non-ad skin disease on the head and neck * active skin infection on the head and neck, or conditions that may interfere with evaluation of the skin

Keywords: eczema itch pruritus head neck
percutaneous inferior cervical sympathetic block for treatment of refractory ventricular tachycardia

Conditions: Ventricular Tachycardia

Summary: the purpose of this research study is to examine the effect of percutaneous inferior cervical sympathetic block on life threatening abnormal heart rhythms called ventricular tachycardia or ventricular fibrillation that can lead to sudden cardiac death.


Eligibility criteria:
inclusion criteria: 1. appropriate icd shock for ventricular tachycardia (vt) after at least one catheter ablation of vt procedure, or appropriate icd shock for vt but not a candidate for catheter ablation of vt (i.e. patients with presence polymorphic vt or ventricular fibrillation, lv thrombus, vt arising from an inaccessible myocardial location). 2. presence of structural heart disease as defined as ef ≤ 50%, presence of ventricular scar as detected by imaging modalities or electroanatomic mapping, hypertrophic cardiomyopathy, cardiac sarcoidosis, or arrhythmogenic right ventricular cardiomyopathy. 3. patient is taking at least one anti-arrhythmic drug or has documented intolerance or toxicity to at least one anti-arrhythmic drug. 4. age greater than 18 years old. 5. able and willing to comply with all pre- and follow-up testing and requirements. 6. provision of signed informed consent and stated willingness to comply with all study procedures for duration of the study. exclusion criteria: 1. active ongoing cardiac ischemia as assessed by: ekg, cardiac enzymes, symptoms, coronary angiography with evidence of significant epicardial coronary stenosis (\>70%), or stress testing. (note: positive troponin assay due to icd shocks is not an exclusion criterion). 2. any medical or non-medical condition likely to prevent completion of trial. 3. contraindication to cardiac sympathetic denervation (i.e. single-lung ventilation, severe pulmonary disease, or severe pulmonary hypertension) or previous cardiac sympathetic denervation procedure. 4. left ventricular assist device or status post orthotopic heart transplantation 5. severe thrombocytopenia (platelets \ 2.0) that is not due to medications or a reversible cause. 6. women who are pregnant (as evidenced by pregnancy test if pre-menopausal). 7. unable or unwilling to comply with protocol requirements. 8. nyha class iv heart failure symptoms. 9. known channelopathy such as long qt syndrome and catecholaminergic polymorphic vt. 10. presentation with slow vt (vt rate \< 150 bpm).
explorative assessment of biomarkers in overweight and obese subjects

Conditions: Prediabetes

Summary: the rationale for this trial is to apply a simple and minimally strenuous pre-screening approach prior to performing more extensive trial-specific screening and baseline-characterization activities in the resulting pre-selected population of subjects.

the pre-screening assessments are designed to characterize the metabolic risk profile / prediabetic status in an unselected population of overweight and obese volunteers, aiming to pre-select high risk and prediabetic subjects as a target population who may specifically profit from primary diabetes intervention (prevention) strategies.

Eligibility criteria:
inclusion criteria: * obese and overweight subjects * considered generally healthy exclusion criteria: * clinically significant acute illness within 2 weeks before study procedures
treat clozapine ( clz )-resistant schizophrenia comparing clz + haloperidol vs. clz + electroconvulsive therapy (ect)

Conditions: Schizophrenia

Summary: clozapine treatment resistant schizophrenia is still prevalent.the effectiveness of augmenting clozapine : one augmenting with haloperidol and the other with electroconvulsive therapy should be determined.this study is a randomized control trial.


Eligibility criteria:
inclusion criteria: 1. schizophrenic patients diagnosed with schedules for clinical assessment in neuropsychiatry ( scan )in accordance with dsm-iv-tr or icd-10 2. resistant to at least 6 weeks of clozapine treatment in therapeutic dosage 3. voluntary to participate the research protocol expressed by signing informed consent form exclusion criteria: 1. patient does not volunteer himself or herself 2. patient is having epilepsy, dm, cardiac disease, autistic disorder and illiterate 3. patient is deaf, blind , dumb to obstruct good communication

Keywords: clozapine-resistant schizophrenics haloperidol augmenting clozapine electroconvulsive therapy augmenting clozapine