Kornimate/medical-research-clean huggingface dataset:
self-catheterization mirror system for female patients

Conditions: Spinal Cord Injury

Summary: the purpose of this study is to test a modified mirror system for female patients to use during self-catheterization.

many female patients have difficulties with self-catheterization. mirrors currently used for this procedure have limited stability and visibility to easily view the urethral opening during catheterization, particularly for individuals with motor impairments. this can be especially frustrating because catheterization is performed frequently throughout the day and may need to occur at home or in public facilities. the purpose of this study is to test the usability and efficacy of a modified self-catheterization mirror system for female patients. the modified self-catheterization mirror system makes adjustments to a standard, hospital-provided cathing mirror to help female patients with a range of motor abilities catheterize themselves in various postures and settings. namely, the system offers (1) an alternative way to hold the mirror, by suspending it between the legs rather than attaching it to the toilet, and (2) lights that can be turned on for improved visibility during the self-catheterization process.

Eligibility criteria:
inclusion criteria: * females age 13 or older * urinary retention related to spinal cord injury or other medical conditions resulting in need for catheterization * individuals with sufficient upper limb function to catheterize independently or with minimal assistance, or as deemed appropriate for the study by the principle investigator. exclusion criteria: * individuals younger than 13 years old * individuals with cognitive deficits or visual impairments that may impact safe use of the devices used * severe rom restrictions of the upper and/or lower extremities * pregnant
an exploratory open label study of epi-743 (vincerinone tm) in children with autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: the investigators hypothesize that epi-743 may provide clinical benefit to children with autism spectrum disorder.

an exploratory open label phase 2 study of epi-743 (vincerinone tm) in children with autism spectrum disorder

Eligibility criteria:
inclusion criteria: 1. diagnosis of autism spectrum disorder as defined by the dsm-v criteria for asd and a gold-standard diagnostic evaluation for asd such as the autism diagnostic observation schedule (ados) and/or the autism diagnostic interview - revised (adi-r) 2. male or female, 3 years to 14 years of age 3. abnormal glutathione cycle biomarkers (gsh/gssg in plasma\<8.0) 4. language impairment (as defined by the celf-2 or celf-4 screener) 5. ability to complete language assessment (using either celf or pls) 6. subject or subject's guardian able to consent and comply with protocol requirements 7. abstention from use of coenzyme q10, vitamin e, lipoic acid, folinic acid, other forms of folic acid above recommended daily allowance (rda), and idebenone 2 months prior to treatment with epi-743 and for duration of study 8. stable regimen of medication and supplements for 2 months prior to enrollment and duration of the study exclusion criteria: 1. allergy to epi-743 or sesame oil 2. allergy to vitamin e 3. clinical history of bleeding or abnormal baseline pt/ptt 4. use of anticoagulant medications 5. participation in any other interventional study within 90 days of treatment. 6. use of antipsychotic medications 7. moderate to severe positive response on abc irritability subscale on questions: injures self on purpose, is aggressive to other children or adults (verbally or physically), deliberately hurts himself/ herself, and/or does physical violence to self 8. severe impairment as defined as a vineland adaptive behavioral scales composite standard score of \<40 9. patients with genetic disease that gives rise to asd (e.g. rett syndrome, down syndrome, fragile x syndrome) 10. abnormal liver function tests two times the upper limit of normal or renal insufficiency with creatinine levels two times the upper limit of normal

Keywords: autism mitochondrial disorders epi-743 epi743 rett syndrome angelman syndrome
the integrated care model for homeless mothers

Conditions: Depression

Summary: the purpose of this study is to pilot test an adapted collaborative care model for homeless mothers with depression.

homeless mothers are more vulnerable to major depressive disorder (mdd) than comparable groups of impoverished mothers, with rates in recent community studies approaching 50%. even though primary care offers an ideal venue to identify and manage depression among women who commonly fail to receive needed mental health services, rigorously tested primary care-based treatment strategies that address the needs of homeless mothers with depression are lacking. this study reports results on a pilot test and feasibility findings of a new intervention, the integrated care model for homeless mothers (icmhm), adapted from the collaborative care model for depression (ccm) to address unique aspects of care for homeless mothers who screened positive for depression during a shelter-based primary care visit.

Eligibility criteria:
inclusion criteria: * mothers who are residing in emergency shelter * 18 years of age or older * screen positive for depression * speak english or spanish exclusion criteria: * not pregnant * not currently receiving depression treatment * not currently psychotic

Keywords: depression homelessness primary care
comparison of postoperative analgesic effect of intrathecal clonidine and fentanyl added to bupivacaine in patients undergoing cesarean section

Conditions: Post Operative Pain

Summary: objective :to compare the analgesic effect of intrathecal clonidine and fentanyl as an additive to bupivacaine in patients undergoing cesarean section . methods:following ethics committee approval and informed patients consent, ninety patients 18-45 yr old asa physical status i or ii, scheduled for cesarean section under spinal anesthesia, were studied in a prospective, double-blinded, randomized way. the patients were randomly allocated to one of three groups of 30 each. the clonidine group (groupc) received bupivacaine 10mg combined with 75microgram clonidine preservative free ,the fentanyl group (group f) received bupivacaine 10mg combined with25microgram fentanyl and the placebo group (group p) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally . time to first requirement of analgesic supplement, sensory block onset time, maximum sensory level , onset of motor block, duration of blockade, hemodynamics variables, the incidence of hypotension, ephedrine requirements, bradycardia ,hypoxemia \[saturation of peripheral oxygen (spo2)\ 4) if time of administration of diclofenac na less than 8h,pethidine 25 mg iv was given.


Eligibility criteria:
inclusion criteria: * patients with american society of anesthesiologists(asa) physical status i and ii, undergoing elective cesarean section exclusion criteria: * significant coexisting disease such as hepato-renal and cardiovascular disease * any contraindication to regional anesthesia such as local infection or bleeding disorders * allergy to ketamine or midazolam * long-term opioid use or a history of chronic pain. -

Keywords: fentanyl clonidine intrathcal bupivacaine
laryngeal mask airway supreme versus the tracheal tube as an airway device in elective laparoscopic cholecystectomy

Conditions: Cholecystitis; Choledocholithiasis

Summary: we hypothesise that the use of the lma-supreme provides greater ease of insertion and reduced haemodynamic variability during insertion compared to the tracheal tube, whilst still maintaining a patent airway to facilitate elective laparoscopic cholecystectomy in selected patients.

the laryngeal mask airway supreme(lma-s) has been used successfully to maintain a patent airway for laparoscopic surgery. our study compares the use of lma-s with that of the tracheal tube (ett) with respect to the ease of insertion and potential haemodynamic disturbance during insertion.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status 1 and 2 * undergoing elective laparoscopic cholecystectomy exclusion criteria: * bmi \> 30 * known gastro-oesophageal reflux disease * predicted or documented difficult airway * contraindications to drugs in the standardized anaesthesia protocol
a dose escalation of gimatecan administered orally to japanese patients with advanced solid tumor.

Conditions: Advanced Solid Tumors

Summary: this study assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in japanese patients. gimatecan is administered orally for five consecutive days, every 28 days, to adult patients with advanced solid tumors who have progressed despite standard therapy or for whom standard systemic therapy does not exist.


Eligibility criteria:
inclusion criteria: * patients with histological or cytological confirmed advanced solid tumors, which have progressed despite standard therapy or for whom no standard therapy exists. * life expectancy of at least 3 months * adequate hematological parameters * no major impairment of renal and hepatic function exclusion criteria: * gastrointestinal dysfunction, such as gastrectomy and malabsorption syndrome that could alter absorption. * patients who have received any investigational compound within the past 28 days. * patients with other antineoplastic therapy within the last 28 days. * patients known to be hiv or hepatitis virus positive, or patients with the presence of active or suspected acute or chronic uncontrolled infection * patients with a history of allergies to the camptothecin family drug. other protocol-defined inclusion/exclusion criteria may apply

Keywords: gimatecan topoisomerase i inhibitor advanced solid tumors
an open-label drug-drug interaction study of telotristat etiprate and fexofenadine in healthy subjects

Conditions: Drug Interactions

Summary: the purpose of this study is to evaluate the effects of steady-state telotristat ethyl on the pharmacokinetics (pk) of single-dose fexofenadine in healthy subjects.


Eligibility criteria:
inclusion criteria: * healthy adult subjects aged ≥18 to ≤55 years of age at screening * body mass index ≥18.0 to ≤32.0 kg/m\^2 * acceptable vital signs at screening: systolic blood pressure = 90-140 mm hg, diastolic blood pressure = 50-90 mm hg, heart rate = 40-100 beats per minute * willingness to adhere to the restrictions outlined in the protocol * able to comprehend and sign the informed consent form exclusion criteria: * presence of any clinically significant physical, laboratory, or ecg finding that may interfere with the study in the opinion of the investigator * use of any medications, herbal tea, energy drink, herbal products, or supplements within 14 days of day 1 * receipt of any investigational agent or study drug within 30 days or 5 half-lives prior to screening * receipt of any protein- or antibody-based therapeutic agent within 3 months of screening * prior exposure to telotristat etiprate * use of tobacco, smoking cessation products, or nicotine products within 3 months prior to screening * history of major surgery within 6 months prior to screening * history of any gi surgery that may induce malabsorption * history of any serious adverse reaction or hypersensitivity to any component of fexofenadine * history of renal disease, or significantly abnormal glomerular filtration rate (\<90 ml/min as calculated using the cockcroft-gault equation) at screening * history of hepatic disease, or significantly abnormal liver function tests at screening * history of any clinically significant psychiatric, renal, hepatic, pancreatic, cardiovascular, neurological, endocrinologic, hematological, or gi abnormality * history of any active infection within 14 days prior to first dosing * history of alcohol or substance abuse within 2 years prior to screening * positive hepatitis panel (including hepatitis b surface antigen and hepatitis c virus antibody) or positive human immunodeficiency virus antibody screens * concurrent conditions that could interfere with safety and/or tolerability measurements * donation or loss of \>500 ml of blood or blood product within 3 months prior to screening * women who are breastfeeding or are planning to become pregnant during the study * positive serum pregnancy test (females only) * positive urine screen for selected drugs of abuse and cotinine * consumption of alcohol within 48 hours prior to study start * consumption of caffeine- and/or xanthine-containing products within 72 hours of study start * consumption of grapefruit, seville oranges, and grapefruit- or seville orange-containing products within 72 hours prior to study start * unable or unwilling to communicate or cooperate with the investigator for any reason * use of any drugs or substances that are known to be substrates, inducers, or inhibitors of cyp3a4 within 30 days prior to the first dose
treatment of pancreatic pseudocysts by endoscopic ultrasound-guided drainage

Conditions: Pancreatic Pseudocyst; Drainage

Summary: patients may evolve pseudocysts of the pancreas secondary to a severe pancreatitis. in case of a symptomatic or infected pseudocyst, a therapeutic drainage of the cyst is indicated. in modern medicine the preferred way to perform such a drainage is by the means of endoscopic ultrasound (eus). it is not precisely elucidated how this eus-procedure should be performed in different scenarios. the cyst appearance and the drainage stents and/or technique may impact the clinical outcome. this study is a prospective, single-center observational study on the outcome after eus-guided drainage of pancreatic pseudocysts.

patintes referred to sahlgrenska university hospital for an eus-guided drainage of a pseudocyst are eligible for inclusion. the drainage is performed at the discretion of an experienced endosonographer. thus, the equipment and the technique used may vary among patients but no randomization is done before the procedure. intraprocedural variables are registered as well as data and outcome parameters from the clinical follow up according to below.

Eligibility criteria:
inclusion criteria: * all patients \>18 years referred to the sahlgrenska university hospital for the performance of an eus-guided pancreatic pseudocyst drainage exclusion criteria: * patients unwilling to participate or unable to understand or sign the informed consent * patients with no need for pseudocyst drainage as assessed by the endosonographer
proximal intestinal obstruction syndrome (pios) in a patient with cystic fibrosis: a new syndrome

Conditions: Cystic Fibrosis; Bowel Obstruction; Distal Intestinal Obstruction Syndrome

Summary: a case of a patient with cystic fibrosis with bowel obstruction due to a proximal intestinal obstruction syndrome (pios) is presented.this syndrome can be diagnosed with the dios definition, with the only distinction of a more proximal location in the gastrointestinal tract, such as the stomach, the duodenum, or the jejunum.

distal intestinal obstruction syndrome is a rare complication in cystic fibrosis patients characterized by the accumulation of viscid fecal material, combined with sticky mucous secretions located in the distal ileum, adhered to the intestinal wall. only few cases have been reported in the literature.

Eligibility criteria:
inclusion criteria: * adult \>18 years * cystic fibrosis * bowel obstruction exclusion criteria: * pediatric patient \<18 years * unknown cause of bowel obstruction
children with aluminium contact allergy: oral exposure study

Conditions: Contact Dermatitis; Contact Allergy; Aluminum Allergy

Summary: aluminium allergy is predominantly seen in children with small itchy nodules in the skin after vaccinations, so-called granulomas. we want to do an exposure study where aluminium allergic children have to eat aluminium pancakes for a short period of time. the purpose is to investigate whether a worsening of the children's symptoms can be detected, both itching of the granuloma, allergic rash on the skin and also the symptoms that are not measurable, such as headache, stomach ache and general agitation. we also want to examine the concentration of aluminium in the urine, which reflects the absorption of aluminum from the gastrointestinal tract.

parents of aluminium allergic children have reported that children may react with increased itching of their granulomas, skin symptoms in the form of redness, itching and rash, as well as symptoms such as headache, abdominal pain and agitation, by ingesting aluminium-containing foods. children are predominantly exposed to aluminium via the diet as they do not yet use aluminium-containing cosmetic products, stomach acid medicines or deodorants. the amount of aluminium in children's diet varies between 0.22-0.90 mg/kg body weight/week, depending on their age. in older children and adults, the intake is less related to the aluminium in infant formula, breakfast cereals and dried fruit, which is consumed more by children than adults. with this study, we want to create an exposure study where children have to eat pancakes for a limited period of time, where aluminium has been used as baking soda, and for two control periods eat pancakes without aluminium. any symptoms occurring during periods could be used to investigate whether children with aluminium allergies generally react after intake of aluminium-containing foods and whether as such it is a consequential condition in some children or whether it is isolated cases. it is a very important issue to clarify with a view to proper advice, both with regard to the possible avoidance of specific foods and in the case of future vaccinations.

Eligibility criteria:
inclusion criteria: * children with contact allergies to aluminium, demonstrated by patch tests * activity (itching) of the granulom within the last six months * written consent obtained from all custodians exclusion criteria: * a detected food allergy for the remaining products in the pancakes (including wheat flour, eggs and milk) * children treated with topical and/or systemic steroid preparations during and up to 1 week before the start of the study. * children treated with systemic immune suppression during and up to 1 week before the start of the study. * children with kidney or bone disease. * children vaccinated during the study period * treatment with acid neutralising medicines during and up to 1 week before the start of the study * another reason for inability to cooperate, including lack of language skills in danish or english in parents.

Keywords: vaccination granuloma aluminium contact allergy exposure
innate immune responses in chronic obstructive pulmonary disease (copd) patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: we hypothesize that ongoing and more severe airway inflammation in copd may result from the impairment in activation of innate immune response


Eligibility criteria:
inclusion criteria: * clinical diagnosis of copd or asthma * a ratio of prebronchodilator fev1 to forced vital capacity (fvc) equal to or less than 0.70 * postbronchodilator fev1 \> or = 50% predicted exclusion criteria: * exacerbation * systemic corticosteroids * dm, hiv and autoimmune disease * immunosuppressive therapy
tackling pressure ulcer via bee venom phonophoresis

Conditions: Bee Venom; Pressure Ulcers; Phonophoresis

Summary: this study aimed to investigate the efficiency of topical bee venom gel versus phonophoresis of bee venom gel to accelerate healing of chronic pressure ulcer

in this study, the bee venom gel was prepared in a gel formula. patients with chronic pressure ulcers were enrolled randomly into two different groups. group 1 received a topical application of bee venom gel, 3 times per weeks. while group 2 received phonophoresis of bee venom gel using low frequency ultrasound, 3 times per week. the treatment lasted for 8 consecutive weeks. the image j software is used to measure the wound surface area before and after treatment.

Eligibility criteria:
inclusion criteria: - patients with stage ii and iii chronic neuropathic ulcers. exclusion criteria: * patients with chronic cardiac, * patients with renal, and * patients with hepatic diseases and * diabetic patients. additionally, * patients with immunosuppressive diseases, * patients with hiv, and * anemia patients

Keywords: phonophoresis bee venom
bakri balloon plus tranexamic acid during cesarean delivery for placenta previa

Conditions: Placenta Previa

Summary: objective to investigate the effect of adjunctive intravenous tranexamic acid (ta) on blood loss during cesarean section (cs) in patients with placenta previa undergone bakri balloon tamponade

placenta previa (pp) is an obstetric condition that is closely linked with massive obstetric hemorrhage with a varied incidence about once in every 200 live births. it is considered one of the causes of the increased need for blood transfusion and cesarean hysterectomy. pph due to pp typically starts during cesarean section (cs) in the placental bed, at the lower uterine segment mostly after placental separation. proceeding for cesarean hysterectomy can be the only effective line of management in spite of the associated high morbidity rate. tranexamic acid is a lysine analog which acts as an antifibrinolytic via competitive inhibition of the binding of plasmin and plasminogen to fibrin. the rationale for its use in the reduction of blood loss depending on the implication of the coagulation and fibrinolysis processes implicated in the control of pph. however, concerns about possible thromboembolic events with parenteral administration of ta have stimulated increasing interest in its topical use.

Eligibility criteria:
inclusion criteria: * women undergoing elective cesarean delivery for complete placenta previa which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures exclusion criteria: * patients with the high possibility of morbid adherent placenta * those presented with severe antepartum hemorrhage * patients with cardiac, hepatic, renal, or thromboembolic disease; * hypersensitivity or contraindications of use of tranexamic acid * patient refuses to consent
prediction of post operative pain following arthroscopic shoulder surgery

Conditions: Arthroscopic Shoulder Surgery; Pain Threshold

Summary: following arthroscopic shoulder surgery a small but significant number of people suffer severe postoperative pain. this study aims to predict which patients are at risk of developing severe post operative pain so that they may be targeted with a more aggressive post operative pain regimen.

patients presenting for elective (day case) arthroscopic shoulder surgery for either arthroscopic subacromial decompression (asd group) or rotator cuff repair (rcr group) are recruited. using a cefar painmatcher, a pain and sensory threshold assessment tool, consenting patients will have their preoperative pain thresholds recorded. the patients will then have a standard anaesthetic administered with tiva (propofol/remifentanil) and either a subacromial injection (asd group) or interscalene block (rcr group). four days following surgery a telephone questionnaire will be completed by the patients recording their worst pain score since surgery.

Eligibility criteria:
inclusion criteria: * all patients aged 18 years or older able to give informed consent undergoing arthroscopic shoulder surgery at nhs fife (asd or rotator cuff repair) exclusion criteria: * unable to give informed consent * allergy to remifentanil, propofol or levobupivacaine. * absence of contralateral arm (thumb/fingers) * documented sensory abnormality (e.g. peripheral neuropathy) * those not consenting to subacromial injection or interscalene block intraopertively (part of routine management after surgery). * psychiatric disease (documented history in hospital notes or gp referral summary) * drug or alcohol misuse (suspicion of or documented) * no telephone or unable to communicate in english (no interpreter service available)

Keywords: arthroscopic shoulder surgery pain threshold