Kornimate/medical-research-clean huggingface dataset:
employment-based depot naltrexone clinical trial ii

Conditions: Opiate Dependence

Summary: the purpose of this study is to determine whether employment-based naltrexone treatment proves effective in promoting depot naltrexone adherence and drug abstinence.

a randomized study is planned to evaluate the effectiveness of employment-based reinforcement in promoting depot naltrexone adherence in opiate-dependent adults. vivitrol, an extended-release depot formulation of naltrexone approved by the fda for the treatment of alcohol dependence, will be used. participants will be offered an inpatient opioid detoxification and oral naltrexone induction. participants who complete the oral naltrexone induction (n=40) will be randomly assigned to one of two groups. both groups will be invited to work in the therapeutic workplace and will be prescribed depot naltrexone for 6 months. participants in the "work plus naltrexone contingency" condition will earn access to working and earning salary by taking depot naltrexone injections once per month. "work plus naltrexone prescription" participants will be encouraged to take depot naltrexone monthly, but access to working and earning salary will not be contingent on doing so.

Eligibility criteria:
individuals were eligible if they: * met the diagnostic and statistical manual (dsm)-iv criteria for opioid dependence, * reported using heroin at least 21 of the last 30 days while living in the community, * were unemployed, * were 18-65 years old, * were medically approved for naltrexone, * lived in or near baltimore, md. individuals were excluded if they: * were pregnant or breastfeeding, * had serum aminotransferase levels over three times normal, * had current hallucinations, delusions, or thought disorders, current suicidal or -homicidal ideation, * expressed interest in methadone treatment, * were required to use opioids for medical purposes, * earned over $200 in taxable income over the previous 30 days, * had physical limitations that would prevent them from using a keyboard, or were incarcerated or under constant monitoring by the criminal justice system.
evaluation of the effect of zingiber officinalis on nausea and vomiting in patients receiving cisplatin based regimens

Conditions: Nausea; Vomiting

Summary: the purpose of this study is to determine whether powdered ginger root (encapsulated ginger) is effective for reducing the frequency, duration and severity of both acute and delayed nausea and vomiting.


Eligibility criteria:
inclusion criteria: * must be able to give written informed consent. * have a diagnosis of cancer and currently receiving chemotherapy containing cisplatin (any dose). * scheduled to receive antiemetics: granisetron (kytril), hydrocortisone. * must be able to complete study questionnaires. * must be able to swallow capsules. exclusion criteria: * have no clinical evidence of current or impending bowel obstruction. * concurrent radiotherapy that is classified as high or intermediate risk of causing emesis. * pregnant or lactating. * patients taking therapeutic doses of coumadin (individuals on low-dose to maintain peripheral or central venous catheters are allowed), aspirin (individuals taking low-dose 80mg aspirin are allowed), or heparin. * patients with a history of a bleeding disorder(s) in past 6 months and those experiencing thrombocytopenia.
baby sickness evaluation

Conditions: Infant, Newborn, Diseases

Summary: the goal of this prospective single center feasibility study is to assess the feasibility of using babycheck and po by gps as an illness severity score for young infants \> 6 months of age in order to aid the decision for referral to hospital. the emergency gp posts in leiderdorp will add the babycheck and po to their standard evaluation of infants presenting with systemic illness \< six months of age for a period of six months. the feasibility will be determined by calculating the percentage of eligible infants in whom a complete babycheck score and po data were retrieved. the investigators consider the protocol feasible if this is done in 80% of all eligible infants.

young infants frequently visit general practitioners (gp) with acute pathology, such as infections. assessing severity of illness in this group is often challenging, since the likelihood of serious illness in this group is low, deterioration of the clinical condition can occur more rapidly. therefore, early recognition of pathology in young babies is pivotal. the netherlands triage system (derived from the manchester triage system) is a reliable tool for both children and adults to decide if a patient should be seen by the gp. however, after presentation at the gp, a scoring system to assess illness severity in babies with a decision aid for referral to hospital, is currently lacking. the babycheck is a scoring system developed and validated as a clinical checklist to assess young infants up to six months of age. the babycheck is validated in multiple low illness prevalent settings. in addition, abnormal oxygen saturation and/or heart rate can be an early sign of infection, respiratory or circulatory pathology in infants. since it is difficult to adequately judge oxygen saturation solely by skin colour, it is preferable to objectify this parameter via pulse oximetry (po). the aim of this study is to assess the feasibility of using babycheck and po by gps as an illness severity score for young infants \< six months of age in order to aid the decision for referral to hospital.

Eligibility criteria:
inclusion criteria: * infants up to six months of age. * presenting with systemic illness (no injuries or traumata). * presenting at the emergency gp post of leiderdorp. exclusion criteria: * infants up to six months of age, presenting with traumata or that are in a resuscitation setting. * infants with referral to other hospitals than the alrijne hospital. the location for referral is coded and available from the anonymized database of the emergency gp post. * infant \ 38.0 ⁰c), with or without unknown origin, since these infants should always be referred according to the national guidelines for gps. * infants \ 38.0 ⁰c), since these infants should always be referred according to the national guidelines for gps.

Keywords: screening babycheck pulse oximetry young infant
trial of yellow 577 nm laser versus green 532 nm laser for proliferative diabetic retinopathy

Conditions: Proliferative Diabetic Retinopathy

Summary: the purpose of this study is to measure effectiveness of yellow 577 nm laser compared to conventional green laser 532 nm for diabetic retinopathy in terms of number of treatment sessions required and visual acuity outcome. the study also compares pain score of patients receiving laser treatment and side effects of laser treatment.

diabetes mellitus (dm) is a major medical problem throughout the world. the most common and potentially most blinding of these complications is proliferative diabetic retinopathy (pdr). panretinal photocoagulation is established as the gold standard of treatment, supported by the data of the diabetic retinopathy study (drs).this study found that laser treatment reduced the rate of severe visual loss by 50%. currently the green 532nm laser is the most common wavelength used. however, this conventional green laser has some complications such as pain, vitreous haemorrhage, choroidal effusion and visual field loss. due to the complication of conventional lasers, the yellow laser (577 nm)with peak absorption of oxyhemoglobin and good absorption of melanin is postulated to be more effective at producing retinal laser burns with a lower power and less pain compared to the green laser.

Eligibility criteria:
inclusion criteria: * patient more than 18 year of age * eyes with proliferative diabetic retinopathy requiring laser prp * newly diagnosed patient * patients with no other intervention/surgeries done before the study exclusion criteria: * eyes with media opacity not allowing adequate laser photocoagulation * patients who have had previous laser photocoagulation * patients who have had previous vitreoretinal surgery

Keywords: diabetic retinopathy laser treatment complications laser wavelength
the effects of metformin in patients with mild graves' ophthalmopathy

Conditions: Mild Graves' Ophthalmopathy

Summary: this is a prospective, randomized, double-blind, placebo-controlled study about the effect of metformin in patients with mild graves' ophthalmopathy. eighty patients with mild ophthalmopathy will be included. each patient will be given either metformin (500mg po three times a day) or placebo ( po three times a day ) for 6 months and then followed for 6 months after withdrawal of treatment.


Eligibility criteria:
inclusion criteria: 1. age 18-80 years 2. patients should not have diabetes (hba1c level at screening should be lower than 6.5) 3. mild graves' ophthalmopathy according to eugogo statement. 4. clinical activity score lower than 4 5. being euthyroid for at least 2 month before the enrollment 6. no previous specific therapy for go in 6 month before the enrollment except for local measures (e.g. eye drops) exclusion criteria: 1. moderate-severe graves' ophthalmopathy 2. clinical activity score ≥ 4 3. contraindication for metformin use as following: renal dysfunction (creatinine level should be within normal range), liver dysfunction (ast and alt levels should be within normal range), severe concomitant illness 4. pregnant women 5. current use of metformin or containing preparations 6. metformin intolerance 7. inability to comply with the study protocol
safety and efficacy study to evaluate proellex in the treatment of premenopausal women with symptomatic endometriosis

Conditions: Endometriosis

Summary: the purpose of this study is to determine whether proellex is safe and effective for the treatment of symptomatic endometriosis.


Eligibility criteria:
inclusion criteria: * premenopausal women aged 18-48 inclusive * endometriosis documented by laparoscopic or surgical assessment within the past ten (10) years * clinical symptoms of endometriosis for at least the past three (3) months * endometriosis symptoms * must be sexually active unless sexually inactive for endometriosis-related dyspareunia * must have a regular or steady menstrual cycle lasting from 24 to 36 days and a detectable ovulation during the baseline period using an ovulation monitoring kit (for timing of endometrial biopsy) * other inclusion criteria may apply exclusion criteria: * six (6) months or more without a menstrual period, or * prior hysterectomy or * prior bilateral oophorectomy * diagnosis of osteopenia * present history or condition that causes non-endometriosis-related dyspareunia * presence of excessive bleeding or menorrhagia * abnormal screening endometrial biopsy * other exclusion criteria may apply

Keywords: endometriosis pelvic pain oral progesterone blocker
adjusted calculation of heparin and protamin dosing and correlation with postoperative bleeding and transfusions

Conditions: Cardiac Surgery; Bleeding; Transfusion; Protamine Sulfate; Heparin

Summary: the study will compare a novel calculation model (heprocalc ab) with a standard weight-based and activated clotting time adjusted calculation for the dosing of heparin and protamine and assess the impact on postoperative bleeding and blood transfusions after cardiac surgery.

during cardiac surgery with cardiopulmonary bypass (cpb), efficient anticoagulation is required in order to avoid microscopic clot formation or, in worst case, massive lift threatening thrombus formation. heparin is by far the most common drug used to prevent blood from coagulating during cpb. activated clotting time (act) is a point-of-care test of fibrin clotting time that has to be well prolonged to initiate safe cpb. following weaning from cpb, heparin is reversed by protamine. administration of excess doses of protamine may have a deleterious effect on coagulation and contribute to postoperative bleeding with need of blood transfusions. in connection with cpb management, heparin and protamin doses are commonly calculated using body weight and act. however, a new heparin-protamin-calculation computer program (heprocalc) has been developed to provide patient titrated dosing of both heparin and protamin. however, any benefits regarding postoperative bleeding and transfusions has not been thoroughly investigated.

Eligibility criteria:
inclusion criteria: * patients undergoing cardiac surgery with the use of cardiopulmonary bypass * indication and planned use of heparin and protamine exclusion criteria: * inability to leave informed consent or understanding the outline of the study * known coagulation disorder
dose-ranging, pk, safety, efficacy study of osanetant in patients with moderate/severe vms associated with menopause

Conditions: Post-menopausal Vasomotor Symptoms

Summary: in this clinical research study, subjects will be given the study drug, acer-801 (osanetant) or placebo (looks like the study drug but contains no active ingredients). the study drug works on a receptor in the brain and the intended purpose is for the study treatment of moderate to severe vasomotor symptoms (vms) also referred to as hot flashes or flushes associated with menopause. hot flashes are a change in your temperature that occurs due to changes in your hormones.

this is a phase 2a, randomized, double-blind, placebo-controlled, dose-ranging study in post menopausal women in which the pharmacokinetics, safety and efficacy of acer-801 (osanetant 50 mg twice daily \[bid\], 100 mg bid, and 200 mg bid) will be compared to placebo. subjects will enter a screening period to determine eligibility. subjects will be required to complete hot flash diaries for 2 weeks prior to randomization. eligible subjects will be admitted to a clinical research unit and remain in the clinic for 14 days after completion of treatment and all study assessments. the study includes a 14 day safety follow-up assessment. subjects will be randomized in a 1:1:1:1 ratio.

Eligibility criteria:
key inclusion criteria: 1. post-menopausal female subjects 40-65 years of age, inclusive. menopause will be defined as: 1. at least 12 months of spontaneous, continuous amenorrhea, or 2. at least 6 months of spontaneous, continuous amenorrhea with serum follicle stimulating hormone (fsh) levels \> 40 miu/ml at screening, or 3. at least 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy. 2. at baseline women: 1. with an average number of moderate to severe hot flashes/day for 2 weeks prior to randomization (per continuous hot flash diary). 2. that have a change of \< 50% in average 24-hour hot flash frequency 2 weeks prior to randomization. * moderate: defined as sensation of heat with sweating, able to continue activity. * severe: defined as sensation of heat with sweating, causing cessation of activity. key exclusion criteria: 1. any active comorbid disease deemed by the investigator to be clinically significant, which could impact safety during study conduct including renal or hepatic impairment. 2. use of any prohibited medications. 3. body mass index (bmi) \>35 kg/m2. 4. any active ongoing condition that could cause difficulty in interpreting vasomotor symptoms. 5. inability to complete questionnaires and continuous hot flash diary for any reason. 6. subjects who, in the opinion of the investigator, should not participate in the study for any other reason.
3d cine cardiovascular magnetic resonance

Conditions: Congenital Heart Disease

Summary: conventional cmr is based on breath-hold 2d cine image acquisitions which are sequentially acquired in different imaging planes. the necessity of precisely planning and then acquiring multiple 2d imaging planes during breath-hold is relatively inefficient and leads to cmr exam times of ≤60 minutes. however, some patients are too ill or young to hold their breath. furthermore, 2d images sometimes fail to provide a complete picture of complex 3d anatomy of patients with complex morphology. to address these limitations, we have recently developed a 3d cine (3 spatial dimensions plus time) cmr technique. rather than acquiring 2d cine images in multiple orientations during breath-hold, this approach allows one to acquire a free-breathing 3d block of data for each phase of cardiac cycle that can be reformatted offline into the desired views without adding to the exam time. this added efficiency should lead to a reduction in cmr exam time, increasing patient comfort, and making cmr exam easy and available for all. in addition, the 3d nature of the data may yield more complete information about the anatomy and physiology. in this proposal, we will examine the agreement between the 2d cine and 3d cine cmr techniques with regard to left and right ventricular volumes and systemic and pulmonary blood flow circulation. the internal consistency of the measurements between the 2 techniques will be also investigated. this study will focus on children because they may benefit the most from the short, improved efficiency, and free-breathing cmr exams.


Eligibility criteria:
inclusion criteria: * patients who are greater than 40 kg and are referred for a clinically indicated 2d cmr exam with a gadolinium-based contrast agent. informed consent/assent will be obtained. exclusion criteria: * patients who are under anesthesia, sedated, or with a contraindication to cmr exams.
interval intraocular pressure in intravitreal injection study

Conditions: Glaucoma; Intraocular Pressure

Summary: this is a prospective study of iop in intravitreal injections to evaluate: 1. iop effect of intravitreal injection 2. iop response to prophylactic beta blocker or prostaglandin vs control (hypromellose) over multiple time periods 3. iop response in correlation to number of injections, iol, type of anti vegf, co morbidities

study design: a prospective study sample size: 60 patients (180 readings) recruitment: patients will be recruited at the intravitreal injection clinic in grantham hospital. randomization: group 1: control (hypromellose), then timolol, then travatan group 2: timolol, then travatan, hypromellose group 3: travatan, then hypromellose, timolol there are three groups of different treatments. patients recruited will undergone all three groups of treatments. during the first injection visit, patients will be randomized (by envelope method upon recruitment) to start with one of the three groups by envelope method. treatment given to each group according to randomization in the first visit, then rotated to second and third group at two subsequent injections accordingly. injection doctors masked to treatments given. study visits: 1. injection visit * record the anti-vfgf injection to be given * macula disease involved * record no. of previous injections * prophylactic eye drops will be given according to treatment group 1 hour prior injection * iop immediately before injection (without speculum while sitting on table) * iop immediately after injection (without speculum while sitting on table) * iop 30 minutes after injection via icare * slitlamp examination, document inflammation or complications if any 2. day 1 follow-up visit * iop via icare (sitting) * slitlamp examination, document inflammation or complications if any 3. week 1 follow-up visit * iop via icare (sitting) * slitlamp examination, document inflammation or complications if any visit a, b and c will be repeated for 2nd and 3rd injections.

Eligibility criteria:
inclusion criteria: * amd patients requiring multiple intravitreal injections (eylea or lucentis), not necessarily 3 month loading. * age \>50 * chinese patients with ability to read chinese icf exclusion criteria: 1. known glaucoma 2. corneal disease e.g. corneal scarring or opacity preventing fundal view 3. on steroid or anti glaucoma eye drops 4. prior vitrectomy or glaucoma surgery 5. recent intraocular surgery i.e. cataracts surgery 6. pseudophakic with anterior chamber iol 7. history of ocular inflammatory disease e.g. uveitis 8. previous laser iridotomy 9. recent intravitreal injection of steroid 10. inability for regular follow-up
a clinical study to evaluate the safety and efficacy of etx101, an aav9-delivered gene therapy in children with scn1a-positive dravet syndrome (australia only)

Conditions: Dravet Syndrome

Summary: wayfinder is a phase 1/2 study in australia to evaluate the safety and efficacy of etx101 in participants with scn1a-positive dravet syndrome aged 6 to \<84 months. the study follows an open-label, dose-escalation design.


Eligibility criteria:
inclusion criteria: * participant must have a predicted loss of function pathogenic or likely pathogenic scn1a variant. * participant must have experienced their first seizure between the ages of 3 and 15 months. * participant must have a clinical diagnosis of dravet syndrome or the treating clinician must have a high clinical suspicion of a diagnosis of dravet syndrome. * participant is receiving at least one prophylactic antiseizure medication. exclusion criteria: * participant has another genetic mutation or clinical comorbidity which could potentially confound the typical dravet phenotype. * participant has a known central nervous system structural and/or vascular abnormality (indicated by an mri or ct scan of the brain). * participant has an abnormality that may interfere with csf distribution and/or has an existing ventriculoperitoneal shunt. * participant is currently taking or has taken antiseizure medications (asms) at a therapeutic dose that are contraindicated in dravet syndrome, including sodium channel blockers. * participant has experienced seizure freedom for a period of 4 consecutive weeks within the 6-month period prior to informed consent. * participant has previously received gene or cell therapy. * participant is currently enrolled in a clinical trial or receiving an investigational therapy. * participant has clinically significant underlying liver disease.

Keywords: dravet scn1a dee developmental and epileptic encephalopathy dravet syndrome scn1a-positive scn1a+
comparison of somnapatch with polysomnography in sleep disordered breathing

Conditions: Obstructive Sleep Apnea; Central Sleep Apnea; Mixed Sleep Apnea; Cheyne-Stokes Respiration

Summary: the purpose of this study is to evaluate the accuracy of somnarus diagnostic technology for diagnosis of sleep apnea in human subjects. this includes evaluation of somnarus technology in obstructive sleep apnea (osa) and central sleep apnea (csa), including cheyne - stokes respiration (csr).

this is a multi- center, open label study to evaluate the accuracy of somnarus device when compared with overnight polysomnographic measurements. the study includes the following steps: screening the database or advertising among cardiologists, neurologists, pulmonologists and ear nose and throat (ent) specialists to identify potential subjects. initial visit, includes: 1. consent discussion and signature 2. history, vital signs, and physical exam night study a. a polysomnogram is conducted and, at the same time, a somnapatch device is used. additional visits if side effects occur, or if the data collection fails, or at the request of the sponsor to repeat the sleep study for further data collection and comparison.

Eligibility criteria:
inclusion criteria: * able to understand and sign the informed consent * able to comply with visits and follow ups included in this protocol * ages 20-85 years exclusion criteria: * an unstable medical condition, acute or chronic, that in the opinion of the investigator puts the subject at health risks related this trial or interferes with the clinical trial and data collection. * skin rash on the nose or on the maxillary area. * a history of skin allergy to medical tape, and hypoallergenic tapes. * a history of skin cancer on the nose or on the maxillary area. * a history of the base of skull fractures, facial fractures

Keywords: apnea hypopnea polysomnography respiratory cheyne