Kornimate/medical-research-clean huggingface dataset:
fentanyl as an adjuvant to peribulbar block in buckle or squint surgeries

Conditions: Pain

Summary: the use of fentanyl as an adjuvant to local anesthetic mixture in many regional blocks. it was effective when used in peribulbar block in cataract and vitreoretinal surgeries. our study will assess its efficacy in abolishing pain during muscle traction which is usually a complain for many patients a reason to use systemic opioid intra operatively or even general anesthesia

after the patient enters the or room, an intravenous cannula will be introduced, pulse oximeter, ecg and nibp monitors will be connected. nasal oxygen cannula connected; 10 ml of local anesthetic mixture is injected depending on the group the patient is allocated. increments of intravenous intravenous fentanyl and midazolam will be given if patient experienced unbearable pain. all patient received peribulbar block by an experienced anesthesiologist, both patient and anesthesiologist were blinded to the drug mixture used. each patient received 10 ml of the anesthetic mixture according to his/ her group. the patient was asked to fix his eyes looking straight forward toward the ceiling while lying in a supine position. a 10 ml syringe with a 25g needle was used for the local anesthetic injection. after negative aspiration, the first 5 ml were slowly injected at the junction of the lateral one third and medial two thirds of the inferior orbital margin with the bevel directed towards the equator of the eye ball parallel to the orbital floor and the other 5 ml were given between the caruncle and the medial canthus. intermittent gentle massage was applied for 10 minutes. after satisfactory sensory and motor block, oxygen 3 l/min was delivered through a nasal cannula to the patient. surgery was then allowed to proceed.

Eligibility criteria:
inclusion criteria: * asa 1, 2 \& 3 * age 18 to 70 * patients undergoing squint or buckle surgeries exclusion criteria: * sensitivity to any drug used in this study * refusal of the patient for peribulbar block * redo squint surgeries or previous buckle insertion * high axial length if documented * mentally retarded patients and * failure of proper communication as in deafness, * coagulation abnormalities (inr\>1.4), * infection at the injection site
observational study of correction of anaemia with darbepoetin alfa at qm dosing interval in patients with ckd not on dialysis

Conditions: Anaemia; Chronic Kidney Disease (CKD)

Summary: to describe anaemia correction via haemoglobin measurements taken throughout observation period in esa naive patients with chronic kidney disease initiated on darbepoetin alfa qm

darbepoetin alfa (aranesp) is a long-acting esa approved for treatment of anaemia in ckd patients, and may be administered once a week (qw), once every two weeks (q2w) or once a month (qm) for correction and for maintenance in ckd patients not on dialysis. prescribing information for darbepoetin alfa was updated in august 2013 (in eu and australia), to incorporate the option for correction at qm dosing frequency in ckd patients not on dialysis. there is very little published literature describing qm correction in a real-world setting. data obtained from this study are intended to contribute to filling a literature gap and to provide a robust source of information for physicians.

Eligibility criteria:
inclusion criteria: 1. patients ≥18 years of age. 2. patients with ckd: 1. not on dialysis at time of darbepoetin alfa initiation at qm dosing frequency. 2. hb \<10g/dl immediately prior to initiation of darbepoetin alfa at qm dosing. 3. commenced darbepoetin alfa at qm dosing frequency during or after august 2013. 4. received at least three consecutive doses of darbepoetin alfa at qm dosing frequency, being the initiation dose and two further doses at qm dosing frequency. 3. patient or patient's legally acceptable representative has provided informed consent, if applicable according to local requirements. exclusion criteria: 1. treatment with an esa within 14 weeks prior to initiation of darbepoetin alfa. 2. patient was enrolled in an interventional device or drug study at any time during the 46-week data observation period or within 30 days prior to commencement of the data observtion period.

Keywords: chronic kidney disease, anaemia correction/maintenance, non dialysis,
actual use study of tamsulosin in men

Conditions: Urological Manifestations

Summary: an actual use study to assess how men who respond to advertisements about urinary symptoms use tamsulosin in a simulated over the counter (otc) setting including following "stop use and ask a doctor if" and "ask a doctor before use" statements and if they take the medication according to the label instructions, also assess any reported adverse events during simulated otc use.


Eligibility criteria:
inclusion criteria: * men, 18 years of age and older, with bothersome urinary symptoms * able to speak, read and understand english * subject or anyone in their household is not currently employed by a marketing or marketing research company, advertising agency or public relations firm, a pharmacy or pharmaceutical company, a manufacturer of medicines, a managed care or health insurance company, as a certified or licensed healthcare professional or in a healthcare practice * has not participated in any clinical trial in the last 12 months * willing to sign an informed consent/hippa form and willing and able to provide contact information exclusion criteria: * allergy to tamsulosin hydrochloride or sulpha drugs * report current use of a medication listed on the "do not use" section of the drug facts label (dfl) * choose not to purchase the study product * do not provide consent or sign hippa form * do not provide contact information
a study to evaluate the safety of max-40070 in healthy subjects

Conditions: Alopecia Areata

Summary: this is a first-in-human phase i study to evaluate the safety, tolerability and pharmacokinetic characteristics of max-40070 in healthy subjectthe study will be comprised of 2 parts; part a and part b. part a will be conducted at nzcr, and part b will be conducted at both nzcr and another site(s) in china (if required). part a will include approximately 48 participants, and part b will include approximately 30 participants.


Eligibility criteria:
inclusion criteria: * weigh at least 50kg (females) or 55kg (males) and have a bmi between 20.0 kg/m2 - 30.0 kg/m2. * subjects having no ulceration, damage, sunburn, redness, rash, acne, folliculitis, pigmentation, uneven skin tone, excessive freckles on the skin of the target application area and fever. exclusion criteria: * an abnormality related to the comprehensive physical examination, laboratory test, 12-lead ecg, and other diagnostic tests and which is determined by the investigator as clinically significant (cs). * a history of cs diseases of heart, liver, lung, kidney, digestive tract, blood, or neuropsychiatric system. * intolerance to venipuncture for blood collection and/or having blood or needle phobia.
comparison of cardiotoxicity induced by selective estrogen receptor modulators and anti-aromatase

Conditions: Cardiac Affections

Summary: selective estrogen receptor modulators and aromatase inhibitors for the treatment of breast cancer seems to have an impact on the cardio-vascular system. this study investigates reports of cardiovascular toxicities for treatment including anatomical therapeutic chemical (atc) classification: l02 in the european pharmacovigilance database, eudravigilance.

hormone replacement therapies and contraceptive pills are responsible of a wide range of cardio-vascular side effects, particularly thrombo-embolic disorders and ischemic heart disease. the difference of incidence and type of cardio-vascular events between men and women are strongly related to sex hormones. this study investigates the main characteristics of patients affected by cardiovascular side effects (of which ventricular arrhythmia's, qt prolongation and torsade de pointe) imputed to drugs classified as l02 according to atc.

Eligibility criteria:
inclusion criteria: * case reported in the eudravigilance from 01/2002 to 08/2017 * adverse event reported were including the meddra terms: soc cardiac affections and the hlt death and sudden death exclusion criteria: -

Keywords: cardiotoxicity selective estrogen receptor modulators aromatase inhibitors hormone replacement therapy estrogen
extension of emdr vs. pc for motor vehicle accident trauma

Conditions: Trauma, Psychological; Motor Vehicle Accident

Summary: this is an extension of a randomized clinical trial comparing eye movement desensitization and reprocessing (emdr) to progressive counting (pc) for volunteers from the community who are distressed by the memory of a motor vehicle accident. the purpose of this extension is to add phil manfield's recently developed flash technique as a precursor to both emdr and pc, to see a) if that has any impact on participant retention, treatment effectiveness, or treatment efficiency; and b) if such impact is equivalent with emdr and pc.


Eligibility criteria:
inclusion criteria: * adult reporting distress related to motor vehicle accident-related trauma * english-speaking exclusion criteria: * already in therapy in which the memory of interest is being actively addressed with a structured/focused trauma resolution method * any obvious/urgent need for more comprehensive psychotherapy (based on initial screening interview) * any indication of instability during interactions prior to the therapy session * an average score on the dissociative experiences scale of 30 or greater, if (as per follow-up questions) indicating a likely dissociative disorder
auricular acupuncture stimulation for chronic pain

Conditions: Low Back Pain

Summary: this proposal aims to investigate the treatment effect and underlying mechanism of transcutaneous acupuncture stimulation on chronic low back pain. we believe that this study, if successful, will provide new treatment options for chronic low back pain, reduce the use of opioid analgesics in chronic pain management, and enhance our understanding of the underlying mechanism of nerve stimulation treatment, as well as the pathophysiology and development of chronic pain.


Eligibility criteria:
inclusion criteria: * volunteers 18-65 years of age. * meet the classification criteria of chronic lbp (having low back pain for more than 6 months), as determined by a referring physician. * received stable treatment or no treatment in the past month. * at least a 10th grade english-reading level. english can be a second language provided that the patients feel they understand all the questions used in the assessment measures. exclusion criteria: * specific causes of back pain (e.g., epidural abscess, compression fracture, spondyloarthropathy, malignancy, cauda equina syndrome) or radicular pain, radiculopathy, or spinal canal stenosis. complicated back problems (e.g., prior back surgery, medico-legal issues). * presence of headache/migraine, as well as widespread body pain such as fibromyalgia. * the intent to undergo surgery during participation in the study. * history of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcomes (e.g., asthma or claustrophobia). * presence of any contraindications to mri scanning (e.g., cardiac pacemaker, metal implants, fear of enclosed spaces, pregnancy, cannot lie still in fmri scanner). * conditions that might confound longitudinal effects or interpretation of results (e.g. severe fibromyalgia, rheumatoid arthritis). * pregnant or lactating. * conditions making study participation difficult (e.g., paralysis, psychoses, or other severe psychological problems as per the judgment of a study investigator during session 1). * active substance abuse disorders within the last 24 months (based on subject self-report). * use of prescription steroids for pain during the past six months. * presence of any other acute or chronic pain disorder. * any medical conditions, such as peripheral neuropathy, that could affect the results of qst.
intravenous iron vs. oral iron supplementation for postpartum anemia

Conditions: Anemia, Iron Deficiency; Delivery Complication

Summary: this trial will be a comparative pragmatic open label feasibility randomized controlled trial of oral daily versus iv iron in anemic postpartum patients. two randomly assigned groups will be compared during the postpartum period: 1. oral iron group: ferrous sulfate 325 mg (65 mg elemental iron) by mouth for a total of 6 weeks tid. iv placebo in sodium chloride 0.9% 500ml iv infusion will be given before discharge home over 1 hour preceded by placebo test dose iv infusion of 100ml 0.9% sodium chloride. 2. iv iron group: low molecular weight iron dextran (infed) 1000mg in sodium chloride 0.9% 500ml iv infusion over 1 hour preceded by test dose 25 mg iv low molecular weight iron dextran infusion in 100ml 0.9% sodium chloride. 2.1 oral placebo will be given by mouth for a total of 6 weeks tid.


Eligibility criteria:
inclusion criteria: * delivery at our institution * hemoglobin below 9 g/dl in postpartum day 1 * singleton gestation exclusion criteria: * diagnosis of malabsorptive disorder or history of gastric bypass procedure * known diagnosis of anemia other than iron deficiency (thalassemia, macrocytic anemia, sickle cell, etc.) * significant cardiovascular disease, including but not limited to myocardial infarction or unstable angina within 6 months prior to study inclusion or current history of nyha class iii or iv congestive heart failure * patient has received blood transfusion or there is a plan to transfuse * lactose intolerance

Keywords: postpartum, iron deficiency anemia, intravenous iron
established lung cancer cell line and stroma cell from surgical tissue

Conditions: Lung Cancer

Summary: try to find lung cancer stem cells from primary culture of routine surgical resection of lung cancer tissue including cancer cells and stroma cells, then characterization the established cell lines, and compare the difference of stroma cells between tumor part and surrounding part.


Eligibility criteria:
inclusion criteria: * lung cancer patient with surgical resection of lung tumor exclusion criteria: * lung cancer patient without surgical resection of lung tumor

Keywords: lung cancer
therapeutic lactose to support vaginal microbiota

Conditions: Bacterial Vaginoses

Summary: the aim of the study was to investigate whether the administration of a vaginal tablet containing lactose can modulate the bacterial flora of women with bacterial vaginosis (bv). design: double-blind, placebo-controlled randomised trial. setting: women with bv who responded to advertisements in local newspapers and on posters at the institutions for education in health science in eastern jutland, denmark. these individuals were supplemented with patients enrolled at a gynaecological clinic. participants: forty women with bv diagnosed through the amsel test. by randomisation, 20 were assigned to receive lactose tablets, and 20 were assigned to receive placebo tablets. interventions: twice daily application of one lactose tablet or placebo tablet for 7 days.


Eligibility criteria:
inclusion criteria: * amsel criteria positive defined as 3/4 of the following: vaginal discharge, fishy odor, ph\>4.5 and clue cells in a wet smear. exclusion criteria: * not able to provide written informed consent.
a pilot trial of ranolazine to treat patients with dilated cardiomyopathy

Conditions: Dilated Cardiomyopathy

Summary: recent data suggest that areas of fibrosis and hibernating myocardium develop in patients with non ischemic dilated cardiomyopathy. ranolazine is a new drug, developed to releave symptoms of angina in patients with stable coronary disease that is not suitable for surgical or percutaneous revascularization. it has been shown that in patients with stable coronary disease ranolazine improves myocardial perfusion as shown with myocardial nuclear imaging. the aim of this trial is to evaluate effects of ranolazine on myocardial perfusion in patients with dilated cardiomyopathy.

recent data suggest that areas of fibrosis and hibernating myocardium develop in patients with non ischemic dilated cardiomyopathy. ranolazine is a new drug, developed to releave symptoms of angina in patients with stable coronary disease that is not suitable for surgical or percutaneous revascularization. the main mechanism of action of ranolazine is the inhibition of late i(na) thus decreasing the ca++ load in the cardiomyocites. consequently oxygen consumption also decreases. it has also been shown that in patients with stable coronary disease ranolazine improves myocardial perfusion as shown with myocardial nuclear imaging. the aim of this trial is to evaluate effects of ranolazine on myocardial perfusion in patients with dilated cardiomyopathy. primary end-point: to determine wheather ranolazine improves perfusion of the myocardium in patients with non-ischemic dilated cardiomyopathy. secondary end-points: to determine wheather ranolazine improves patients' nyha functional class, excercise capacity, lv systolic and diastolic function and weather ranolazine affects supraventricular and ventricular arrhythmia occurance/frequency.

Eligibility criteria:
inclusion criteria: * established diagnosis of non-ischemic dilated cardiomyopathy * ef \< 35% * nyha f.c. ii - iv * optimal medical management \> 6 months * age \ 18 years exclusion criteria: * known hypersensitivity to the medication * age \> 75 years or \< 18 years * ef \> 35% * renal insufficiency (gf \< 30) * liver dysfunction (liver tests \> 3x the upper normal limit)) * lqt syndrome * drugs that affect cyp3a4 metabolism (azoles, macrolides, calcineurin inhibitors etc.) * dementia * active hemathological or malignant disease
a long-term follow-up study of patients with mps iiib treated with abo-101

Conditions: Mucopolysaccharidosis III-B

Summary: this is a multicenter, non-interventional, long-term follow-up (ltfu) study in participants who have been treated with abo-101 in a prior trial. eligible participants will undergo clinical evaluations at prespecified intervals for 3 years from the last visit in the prior clinical trial (up to 5 years post-treatment).

this is a multicenter, noninterventional, long-term follow-up study of patients with (mucopolysaccharidosis iiib) mps iiib who have completed a prior clinical trial involving the administration of abo-101. this study is designed to provide ltfu in accordance with the fda and european medicines agency (ema) guidelines for patients treated with gene therapy products. the duration of the current study is 3 years for a total of up to 5 years post-treatment for these participants who rollover from a prior clinical trial of abo-101. participants will have a maximum of 5 annual scheduled visits with assessments as specified in the schedule of assessments.

Eligibility criteria:
inclusion criteria: * participants that have completed a prior clinical trial involving the administration of abo-101 * parent(s)/legal guardian(s) of participant willing and able to complete the informed consent process and comply with study procedures and visit schedule exclusion criteria: * planned or current participation in another clinical trial that may confound the safety and efficacy evaluation of abo-101 during the duration of this study * any other situation that precludes the participant from undergoing procedures required in this study

Keywords: mps iiib mucopolysaccharidosis iiib sanfilippo b
prospective randomized, controlled trial for treatment of intraventricular hemorrhage

Conditions: Intraventricular Hemorrhage

Summary: intraventricular hemorrhage comprises about 15% of the 500,000 strokes that occur annually in the united states. in the emergent setting, patients with obstructive hydrocephalus are routinely treated with placement of an external ventricular drain. this study will compare the effect of external ventricular drainage plus intraventricular thrombolysis versus external ventricular drainage plus endoscopic evacuation on neurologic outcomes for patients with hydrocephalus from intraventricular hemorrhage.


Eligibility criteria:
inclusion criteria: * age 18-75 * radiographic evidence of intraventricular hemorrhage with hydrocephalus * admission glasgow coma scale ≥ 5 (motor score ≥ 2) * placement of an external ventricular drain with an opening pressure \>20 mm hg exclusion criteria: * intraventricular hemorrhage secondary to cerebral aneurysm, arteriovenous malformation, or tumor * coagulopathy (platelet count \ 1.5. reversal of warfarin is permitted.) * age \ 75 * pregnancy (positive pregnancy test) * clotting disorders * medical contraindications to administration of general anesthesia as determined by the attending anesthesiologist * medical contraindications to surgery as determined by the attending neurosurgeon * contraindication to recombinant tissue plasminogen activator administration: * evidence of enlargening intracranial hemorrhage as evidenced by an increase in intracranial hemorrhage volume (\>5 ml) on ct obtained after evd placement * internal bleeding, involving retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts * superficial or surface bleeding, observed at vascular puncture and access sites (e.g. venous cutdowns, arterial punctures) or site of recent surgical intervention * evidence of cerebrospinal infection by gram stain or culture * advanced directive indicating do not resuscitate or do not intubate status
postoperative analgesic effects of infraorbital nerve block in cleft palate surgery

Conditions: Pain, Postoperative

Summary: cleft palate repair is a common surgery in children.. as such children with cleft palate tend to have a compromised airway due to associated congenital anomalies like pierre robin syndrome, treacher collins syndrome etc. after surgical correction of cleft palate, they are more prone to develop post-operative respiratory difficulty due to narrowed airway, increased secretion, pain and sedation caused by opioids. hence, regional block, using local anesthetics, becomes a good option in this surgery. the supremacy of bilateral infraorital block using levo bupivacaine over intravenous fentanyl as well as over peri-incisional infiltration in has been shown .levobupivacaine was developed after ropivaciane was noted to be associated with less no of adverse events.. ropivacaine has been used for peripheral block in children for surgical pain. though the use of levobupivacaine in regional blocks in facial surgeries has been well established, studies are still needed to establish its supremacy over ropivacaine in cleft palate surgeries

when compared with ropivacaine, levobupivacaine is a newer, safer, longer acting local anesthetic with rapid onset and prolonged duration of analgesia and similar or more pronounced nerve blocking effects, depending on the concentration. hence the present study is aimed to compare the effectiveness of 0.375% levobupivacaine and 0..375% ropivacaine in infra orbital block for cleft palate surgery.

Eligibility criteria:
inclusion criteria: * children in the age of 2-12 years * children undergoing elective surgery for cleft palate. * children who are conscious and willing to participate in the study. * children who speak and understand english, hindi, local or others. exclusion criteria: * patient's refusal * allergy to the amide group of local anaesthetic agent * patient on anticoagulants or bleeding disorder * underlying other significant systemic diseases.