Kornimate/medical-research-clean huggingface dataset:
soft- stereotactic ablative radiotherapy of infra-diaphragmatic soft tissue metastases

Conditions: Solid Tumor; Oligometastases; Soft Tissue Disease

Summary: the soft study will evaluate the feasibility and safety of mr-guided stereotactic ablative radiotherapy (sabr) for infra-diaphragmatic soft tissue metastases.

the investigators wish to evaluate the safety and feasibility of mr-guided stereotactic radiation to patients with infra-diaphragmatic oligometastatic disease including quality of life assessments and patient-reported outcome measures. further, the investigators assess clinical response among patients with oligometastatic disease (omd), defined as up to five metastases in up to three different organs.

Eligibility criteria:
inclusion criteria: * histology or cytology proven non-haematological cancer. * at least one metastasis should be localized in the infra-diaphragmatic soft tissue. * eastern cooperative oncology group (ecog) scale of performance status ≤ 2. * ≥ 18 years old. * life expectancy \> 6 months. * target diameter (gtv) ≤ 5 cm. * metastatic lesions must be visible, imaging defined targets and suitable for treatment with sabr. * in case of de novo omd and oligometastatic recurrence a maximum of 5 targets (including the primary tumour) in a maximum of 3 organ sites are allowed. * in case of oligoprogressive disease (opd) \* and induced omd \*\* only 3 metastases (including the primary tumour) are allowed. * all metastatic sites are treated or planned for ablative therapy (including surgery). for opd, only the sites in progression is required to fulfil this criterion. * a baseline scan within 28 days of inclusion (pet-ct or ct and mr scanning). * no curative intended treatment option available. * an ablative strategy should be deemed clinically relevant and it is at the discretion of the treating physician to decide. * ability to understand and the willingness to sign a written informed consent document. * if the target is in the liver, a child-pugh score a is required. exclusion criteria: * patient cannot tolerate physical set up required for sabr. * active bowel obstruction. * uncontrolled intercurrent illness. * medical contraindication to undergoing mr-imaging. * pregnancy. * patients with uncontrolled brain metastases. * uncontrolled disease in respect to malignant pleural effusion, ascites, lymphangitic carcinomatosis, pleural carcinomatosis or peritoneal carcinomatosis. * if the patient has received previous radiotherapy, the combined dose at the radiation site must not exceed the dose constraints.

Keywords: sbrt sabr mr-guided radiotherapy
study in myeloma patients newly diagnosed treated as an induction with velcade-dex or velcade (bortezomib) thalidomide dexamethasone (vtd)

Conditions: Multiple Myeloma

Summary: primary objective: * compare the complete remission (cr) rates (i.e., the true cr, with negative immunofixation) achieved with either four courses of vd or four courses of vtd. secondary objectives: * compare the following parameters following 4 cycles of vd or vtd induction treatment: * cr rate+ very good partial remission (vgpr) rate * overall remission rate (cr + vgpr + partial remission (pr) rate) * k/l light chain ratio in patients in cr. * safety (quality of the sampled stem cells, extrahaematological and haematological toxicity: specially neurological toxicity, length of hospitalization). * compare the cr rate and the cr + vgpr rates after post-induction autologous stem cell transplantation (asct).


Eligibility criteria:
inclusion criteria: * newly diagnosed symptomatic multiple myeloma (mm) patient * aged under 65 * candidate for asct, with measurable levels of paraprotein in the serum (³ 10 g/l) or the urine (³ 200 mg/day) * using effective contraceptive methods (for fertile men, women of childbearing potential) * provision of informed consent * no evidence of active infection exclusion criteria: * asymptomatic mm * non-secretory mm * aged 66 years or over * ecog performance status over 2 (see appendix 2) * proven amyloidosis * a personal medical history of cancer (except for basocellular skin cancer or in situ cervical cancer) * positive hiv serology * a personal medical history of severe psychiatric disease * severe diabetes contraindicating the use of high-dose dexamethasone * nci grade ³ 2 peripheral neuropathy * serum clinical chemistry: * creatinine level \> 300 µmol/l or requiring dialysis * bilirubin, transaminases or gamagt \> 3 the upper normal limit (unl) * prior or current systemic therapy for mm, including steroids (except for emergency use of a 4-day block of dexamethasone between the screening phase and randomization) * radiation therapy in the 2 weeks preceding randomization * a personal medical history of allergic reactions to compounds containing boron or mannitol * non-controlled or severe cardiovascular disease (including a myocardial infarction in the 6 months prior to recruitment) or nyha class iii or iv renal failure * use of any investigational drug in the 30 days preceding randomization * pregnant or lactating women; a serum beta-hcg pregnancy test must be performed during the screening phase for female patients of childbearing potential * severe pulmonary troubles (including acute infiltrative pneumopathy)

Keywords: newly diagnosed multiple myeloma induction thalidomide
study of the efficacy of human recombinant factor viii (kogenate fs) reconstituted in pegylated liposomes.

Conditions: Haemophilia A

Summary: primary efficacy endpoint: to study whether there is a difference in the length of the bleeding free periods between infusion of fviii that is reconstituted with 22.1, 12.6, or 4.2 mg of pegylated liposomes per kg bwt compared with standard formulation. safety endpoint: to study the safety and tolerability of kogenate fs reconstituted with pegylated liposomes

each subject will receive treatment for three bleeding episodes ("wash-in", on demand injections) followed by a minimum 4 day wash-out. following this each subject will be randomized to a specific treatment order. each order consists of four identical blocks. in each block the following three injections will be given: 1 one prophylactic treatment (randomized solution for dissolution) 2 and 3. two standard on-demand treatments for a spontaneous bleeding episode (standard kogenate fs). each block will be followed by a four day wash-out. in total each subject should receive 3+4x3=15 injections. it is estimated that each subject will be in the study for about 4 months. a treatment for a spontaneous bleeding episode may require more than one infusion.

Eligibility criteria:
inclusion criteria: * between 18 and 60 years of age * severe haemophilia a (≤ 1% of baseline factor viii activity) * at least 250 treatment cumulative exposure-days (ceds) to previous products * at least 25 cumulative exposure-days (ceds) to previous products during one year prior to study start * if hiv positive, cd4 lymphocytes ≥ 400/µl * subjects on demand treatment, and with a minimum bleeding/treatment pattern of a four episodes per month, evenly distributed within each month, during the three month preceding study start * subjects who have given their written informed consent. exclusion criteria: * inhibitors or history of inhibitors * history of adverse reactions related to factor viii * platelet count \<90,000 /µl * subjects on prophylaxis treatment * subjects with concomitant debilitating disease (e.g. cancer, non-controlled diabetes, heart insufficiency, renal failure) * subjects with known sensitivity to blood products * subjects who have participated in another ethical committee approved clinical trial (including medical device studies) within the past 30 days * subjects with a weight over 86 kg or below 50 kg * subjects who do not understand or are not willing to comply with the requirement of the study protocol * subjects who cannot differentiate a bleeding episode from other causes of joint pain

Keywords: bleeding disorder severe haemophilia a prophylaxis
efficacy and safety of diclofenac potassium 25 mg tablet taken three times daily in subjects with acute joint pain

Conditions: Ankle Sprain

Summary: the purpose of this study is to evaluate the efficacy of diclofenac potassium 25 mg tablet compared with placebo taken three times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief.


Eligibility criteria:
inclusion criteria: * male or female aged 18 years and over. * acute sprain of the lateral ankle, grade i-ii, meeting baseline pain intensity level. * injury within past 12 hours. exclusion criteria: * pain medication was taken within the 6 hours that precede randomization. * during the past 3 months: grade i-iii sprain of the same ankle. * during the past 6 months: grade ii-iii sprain, any other significant injury (such as fracture or torn ligament), or surgery (except for skin or nails) of the same ankle or foot. * pain or instability in the same ankle attributable to previous ankle sprain or any other trauma. * ankle sprain attributable to a known disease affecting the ligaments, such as ligament hyperlaxity due to connective tissue disease (e.g., marfan's syndrome, down's syndrome, ehlers-danlos syndrome).

Keywords: acute joint pain
svt-15652 otic solution for the treatment of otomycosis.

Conditions: Otomycosis

Summary: multicenter, randomized, 2-arm parallel-group, double blind, placebo-controlled study in patients suffering from otomycosis. this study will compare the efficacy and safety of svt-15652 otic solution to that of placebo, when administering one vial twice daily during 14 days.


Eligibility criteria:
main inclusion criteria: * at least 18 years of age * clinical diagnosis of otomycosis in one or both ears, where topical treatment is indicated. * signs/symptoms of pruritus, otalgia and ear fullness. * debris or drainage clinically consistent with fungal infection. main exclusion criteria: * known bacterial otitis externa or malignant otitis externa. * tympanic perforation, tympanostomy tubes inserted and post mastoid surgery. * structural ear anomalies which may difficult the evaluation of the therapeutic response. * uncontrolled diabetes mellitus. * any infection requiring systemic antimicrobial or systemic antifungal therapy. * concomitant medicines that may interfere with the study evaluations.
habitual hypertension medication adherence in arizona

Conditions: Medication Adherence; Habits; Hypertension

Summary: this research will implement a novel habit formation intervention among people living with hypertension and an indication of medication non-adherence to help maintain high anti-hypertensive (ah) medication adherence by leveraging the power of routines and unconsciously triggered habitual behaviors. the investigators will test whether high ah medication adherence can be maintained using contextually-cued medication adherence habits that mitigate the negative effects of declining motivation, forgetfulness, and the cognitive burden of performing repeated daily behaviors. the use of mhealth tools will help to make this a scalable and sustainable intervention approach for addressing an important healthcare issue in arizona.


Eligibility criteria:
inclusion criteria: * aged 18 years old or older * currently diagnosed with hypertension (either stage i or stage ii hypertension) * able to read/write/understand english * have daily access to a smartphone * engaged in hypertension care (i.e., already been prescribed antihypertensive medication for a minimum of 12 months at the time of study enrollment) * demonstrated antihypertensive medication nonadherence by having over 73 days without documented antihypertensive medication prescription coverage (observable in arizona health care cost containment system (ahcccs) prescription drugs claims) in the past 12 months (i.e., \>80% mean adherence) exclusion criteria: * less than 18 years old * does not have current hypertension diagnosis * unable to read/write/understand english * does not have daily access to a smartphone * not currently engaged in hypertension care * has not demonstrated antihypertensive medication nonadherence within the past 12 months
evaluation of the roll of iv fluids in the treatment of renal colic

Conditions: Renal Colic

Summary: a randomised controlled trial to evaluate the role of iv fluids in renal colic.

a rct (randomized controlled trial)to evaluate the role of 0.9% nacl (sodium chloride) iv fluids during an acute renal colic. the 2 arms will include - 1. 2 liters of 0.9% nacl iv fluids with pain killers 2. only pain killers the object is to find out if the iv fluids has any advantage in the care of renal colic. does it helps to relive the pain? does the stone eject earlier? will there be fewer interventions?

Eligibility criteria:
inclusion criteria: * above 18 years * clinical renal colic * a radiological proof (ct,us) to urolithiasis exclusion criteria: * below 18 years * has a contraindication for iv fluids (such as chf (congestive heart failure)etc.)
pet imaging in als patients

Conditions: Amyotrophic Lateral Sclerosis (ALS)

Summary: this is a pilot study to evaluate a potential imaging biomarker for aiding diagnosis and monitoring progression of als, based on a well established basic science pathway, published human autopsy data, preliminary data in als mutant mice, and our recently published data using brain pet scans to image the metabotropic glutamate receptor type 5 (mglur5) in healthy human volunteers.


Eligibility criteria:
inclusion criteria: * male or female als patients, ranging in age from 18-80. * must meet el escorial criteria for probable or definite als. * disease duration \>1 year, but \<3 years. * weakness in at least two extremities. * forced vital capacity less than 80% and greater than 50%. exclusion criteria: * documented orthopnea or otherwise unable to lie flat in a pet scanner for 90 minutes. * presence of pacemakers, aneurysm clips, shrapnel, or other implanted metallic devices that would preclude an mri scan. * absence of sufficient collateral arterial circulation for radial arterial line placement in both wrists. * significant abnormalities of hepatic or renal function, or illicit substance use. * positive drug screen. (subjects currently taking prescribed narcotic medication who have a positive drug screen for this medication will not be excluded. medication history will be obtained during screening). * weighs \> 350 lbs.
conventional versus left bundle branch pacing in tavi

Conditions: Aortic Valve Stenosis; Heart Failure; Pacemaker-Induced Cardiomyopathy; Transcatheter Aortic Valve Implantation

Summary: this randomized study compares the effects of conventional (right ventricular pacing in patients with lvef ≥ 40% and cardiac resynchronization therapy in patients with lvef \< 40 %) versus left bundle branch pacing on left ventricular remodelling in patients with reduced left ventricular ejection fraction (\< 50 %) that need permanent pacemaker implantation after transcatheter aortic valve implantation (tavi).

bradycardic heart rhythm disturbances are a common complication of tavi. patients who will develop the indication for permanent pacemaker implantation after tavi will be randomly assigned to either the experimental (left bundle branch pacing) or conventional (right ventricular pacing in patients with lvef ≥ 40% and cardiac resynchronization therapy in patients with lvef \< 40 %) group. the investigators will compare the left ventricular ejection fraction (primary outcome) 12 months after randomization. the investigators will also compare electrocardiographic (qrs duration), clinical (nyha status, 6-minute walking test, handgrip test, kansas city cardiomyopathy questionnaire) and laboratory (probnp) parameters 6 and 12 months, and other echocardiographic (left ventricular systolic and diastolic diameter, signs of dyssynchrony, myocardial work) parameters 12 months after pacemaker implantation in both groups.

Eligibility criteria:
inclusion criteria: * indication for permanent pacemaker implantation after transcatheter aortic valve implantation (during the same hospitalization) * left ventricular ejection fraction \< 50 %. exclusion criteria: * unsuccessful tavi procedure with life expectancy \< 1 year * ischemic cardiomyopathy with interventricular septal fibrosis (at least echocardiographic signs of fibrosis) * severe kidney failure (glomerular filtration rate \< 30 ml/min) * previous permanent pacemaker

Keywords: transcatheter aortic valve implantation left bundle branch pacing
sleep-disordered breathing and pap in perinatal depression

Conditions: Sleep-disordered Breathing; Major Depressive Disorder

Summary: the goal of this study is to understand the contribution of sleep-disordered breathing (sdb) to one of the most common and debilitating adverse pregnancy outcomes, perinatal depression. the study is a randomized trial to test the efficacy of positive airway pressure (pap) on sleep and depression symptoms in perinatal women. participants will be pregnant women with depression and sleep-disordered breathing. participants will be randomly assigned to receive either pap therapy (pap group) or treatment as usual within obstetrics (tau group). mood and sleep assessments will be completed at baseline, after 1 week of enrollment, and monthly thereafter through 12 weeks postpartum. cortisol will be measured using saliva collection at baseline and again 8 weeks later.


Eligibility criteria:
inclusion criteria: * 20-32 weeks gestation with a single, live fetus * meet criteria for major depressive disorder per the structured clinical interview for dsm-v (scid) * respiratory distress index (rdi; includes apneas, hypopneas, and respiratory effort-related arousals)≥5 per ambulatory assessment plus apnea symptoms (snoring, witnessed apnea, daytime sleepiness, sleep disturbance, snort arousals) * stable dose (for ≥8 weeks) of a selective serotonin reuptake inhibitor (ssri) or free of all antidepressant medications past 4 weeks * obstetrics care is at the university of michigan, and the woman plans on delivering her baby at the university of michigan exclusion criteria: * diagnosis of bipolar disorder, posttraumatic stress disorder, schizophrenia or psychosis, dissociative disorders, eating disorder, obsessive-compulsive disorder, somatic symptom and related disorders, substance use disorder, panic disorder, agoraphobia per dsm-v * diagnosis of, or suspicion for, narcolepsy or rem behavior disorder * current sdb treatment; medical conditions for which pap is contraindicated (e.g., pneumothorax, pneumocephalus, recent trauma, recent surgery) * evidence of risk for drowsy driving (excessive daytime sleepiness plus history of motor vehicle accident or near miss due to sleepiness, fatigue, or inattention in past 12 months).
vr-assisted curriculum on depression for stigma reduction

Conditions: Control; Behavior

Summary: two randomised controlled trials will be conducted to evaluate a virtual reality (vr) simulation designed to reduce stigma against depression. qualitative interviews will also be carried out to evaluate the vr simulation.

the investigators examine the impact of a vr-assisted curriculum on stigma reduction towards individuals with depression. this is done through the development and evaluation of a vr-assisted curriculum that promotes stigma reduction towards depression among tertiary-aged students. collection of data will provide insights about the effectiveness of vr's immersive quality in enhancing stigma reduction skills through measures of attitudes, beliefs and knowledge about depression. in the first study, vr is compared with traditional pamphlets in an information sharing booth about depression. in the second study, participants attend a 30-min session where they undergo an educational curriculum with either a vr or standard video as adjunctive tools.

Eligibility criteria:
inclusion criteria: * tertiary students from nus and yale-nus only exclusion criteria: * history of medical or psychiatric disorder; history of motion sickness, dizziness or epilepsy; (for reliability and safety of heart-rate monitoring) tattoos near the wrist and/or nickel or acrylate allergies

Keywords: virtual reality stigma reduction depression mental health campaigns user experience enjoyment presence
hepatitis c prevalence in men who have sex with men

Conditions: Hepatitis C

Summary: this is an observational study aimed at determining the prevalence of hepatitis c in a specific population: men who have sex with men.


Eligibility criteria:
inclusion criteria: * having sex with men exclusion criteria: * refusal to participate in the trial

Keywords: hepatitis c
daily wear corneal infiltrative event study

Conditions: Myopia; Hyperopia; Corneal Infiltrative Events

Summary: this dwcie study is a prospective cohort study of patients fit to the fda approved and marketed lotrafilcon a (ciba vision, air optix night \& day aqua) soft contact lenses for daily wear (dw) with monthly disposal. 218 healthy myopic (nearsighted) or hyperopic (farsighted) patients with minimal or no astigmatism and no contraindications to dw lens use will be followed for 1 year. the primary outcome is the risk of development of a corneal inflammatory event (cie) as defined by slit lamp findings and patient symptoms. the main exposure of interest is microbial contamination of study lenses.


Eligibility criteria:
inclusion criteria: 1. the patient must be at least 15 years old. 2. the patient must be free of any anterior segment disorders. 3. the patient must have a spectacle corrected spherical refractive error between +5.50 d and -11.00 d with less than or equal to 1.00 d refractive cylinder. 4. the patient must be correctable to 20/25 or better with spectacles. 5. flat and steep corneal curvatures from simulated keratometry readings must be between 39.00 and 48.00 d. 6. can be successfully fit with lotrafilcon a lenses at the enrollment visit. exclusion criteria 1. the patient has worn rigid gas permeable lenses within the last 30 days or polymethylmethacrylate lenses within the last 3 months. 2. the patient must not be a current successful daily wear user of lotrafilcon a lenses. they may have tried lotrafilcon a lenses in the past, but must not have successfully worn these lenses for daily wear within the last 12 months. 3. the patient has an autoimmune disease (except for hashimoto's thyroiditis), immunocompromising disease, connective tissue disease, atopic dermatitis, insulin dependent diabetes, or any other systemic disease that in the investigator's opinion will affect ocular health. 4. the patient is taking chronic systemic medications such as corticosteroids, antimetabolites, or non-steroidal anti-inflammatory agents or any other medication that in the investigator's opinion will affect ocular physiology or study participation. 5. the patient has any ocular disease or condition such as aphakia, corneal dystrophies, corneal edema, external ocular infection, iritis, or had any anterior segment surgery. 6. the patient is taking any ocular medications. if a patient was previously taking any ocular medications, the medications must have been discontinued at least 2 weeks prior to enrollment. 7. the patient must have less than or equal to grade 2 on any of the slit lamp observations of: upper tarsal papilla, corneal staining, corneal neovascularization, conjunctival injection, and lid erythema or scales. slit lamp findings higher than grade 2 bias the patient toward an adverse event and it may be difficult to detect true change related to contact lens use. 8. the patient is pregnant.
hyzaar vs. ramipril for diabetes (0954a-245)(completed)

Conditions: Type 2 Diabetes Mellitus; Hypertension

Summary: a study to test the safety and efficacy of hyzaar as compared to ramipril in patients with type 2 diabetes mellitus (high blood sugar) and hypertension (high blood pressure).


Eligibility criteria:
inclusion criteria: * patient is at least 18 years old, has been diagnosed with type 2 diabetes mellitus exclusion criteria: * patient has renal disease, malignant hypertension, uncontrolled type 2 diabetes mellitus, history of stroke, tia (transient ischemic attacks) , or heart disease