Kornimate/medical-research-clean huggingface dataset:
survey of human rabies immune globulin safety in children

Conditions: Rabies; Rabies Human; Rabies Virus Infection; Pediatrics

Summary: this observational study will be conducted across the houston methodist system, including all hospital-based and freestanding emergency departments (ed), and up to 4 additional sites in the united states. the safety of human rabies immune globulin (hrig) 300 iu/ml product (hyperrab®) in pediatric patients has not been fully established. the purpose of this study is to evaluate the safety of hrig 300 iu/ml when given to pediatric patients per standard of care for rabies postexposure prophylaxis (pep) in the ed.

background: rabies pep consists of thorough wound cleansing, administration of hrig 20 iu/kg body weight, and 4 to 5 doses of rabies vaccine. the safety of hrig 300 iu/ml has been confirmed only for adult patients. although the safety of hrig 300 iu/ml in the pediatric population has not been fully established, there is no age limit on the fda approved indication for hrig 300 iu/ml, and it is routinely administered to pediatric patients as standard of care in the united states. study design: this observational, multicenter, prospective study will collect information on safety events that occur up to 30 days after standard of care administration of hrig 300 iu/ml among pediatric patients (age ≤17 years) at up to 5 study sites in the united states. safety data will be collected using surveys and chart review of the health record. all participants will receive hrig 300 iu/ml per standard of care prior to joining this study. the day of hrig 300 iu/ml administration will be defined as day 0. the study will conduct survey 1 on day 2 and survey 2 on day 10 to collect information on adverse events (aes). investigators will review the electronic health record on day 30 to collect additional information on aes. if a serious adverse event is detected during survey 1, survey 2, or the 30-day chart review and is not previously documented as being resolved or stabilized the study will conduct survey 3 on day 30.

Eligibility criteria:
inclusion criteria 1. received hrig 300 iu/ml for rabies pep during an ed encounter visit 2. aged ≤17 years exclusion criteria 1. hrig 300 iu/ml dose given is \ 22 iu/kg 2. patient is admitted or transferred to a hospital from the ed for further management of injuries related to the animal exposure 3. patient has a history of rabies vaccine or rabies immune globulin administration 4. legally authorized representative (parent) does not speak english if patient is \<7 years old 5. legally authorized representative (parent) or patient does not speak english if patient is 7 to 17 years old 6. inability to obtain consent 1. more than 3 days passed since hrig 300 iu/ml administration prior to screen 2. unable to contact legally authorized representative (parent) and/or patient within 3 days of hrig 300 iu/ml administration 3. legally authorized representative (parent) and/or patient declined participation 7. administration sites for hrig are unknown

Keywords: pediatrics rabies post-exposure prophylaxis rabies pep rabies immune globulin rabies ig adverse events
acceptance and usability of an app promoting healthy behaviours amongst young women at increased risk of breast cancer

Conditions: Breast Cancer; Overweight and Obesity; Diet, Healthy; Weight Gain; Alcohol Drinking; Smoking Behaviors; Healthy Nutrition; Healthy Lifestyle; Healthy Eating Index

Summary: it is estimated that around 20% of breast cancers (bc) in the uk are preventable through adherence to appropriate health behaviours, i.e., healthy diet, physical activity, limited alcohol, not smoking, and that women at increased risk of bc could benefit from greater decreases in risk than the general population via health behaviour changes. young women (age \<35 years) who are at increased risk of developing bc currently receive little or no information regarding health behaviours and bc risk, or support for behaviour change. this feasibility study aims to explore whether a novel app is acceptable to women at increased risk and could potentially engage them with improved health behaviours which could reduce their future risk of bc.

aims 1. to assess the acceptability and usability of the app to young women at increased risk of bc 2. to assess the feasibility of study procedures before running a future efficacy study using the app as an intervention objectives 1. explore views of users of the experiences during and after using the app 2. explore views of users on their experience of the two different recruitment procedures (targeted mailshot, or social media, newsletters and websites), and the online consent procedure. 3. interpret user data from the app including frequency and patterns of use of the different functions 4. analyse recruitment data to explore how the two different recruitment procedures could be improved for the next study 5. assemble a list of suggested changes to recruitment and consent procedures, and to the app, to be considered before the next study. 6. quantify health care professional (hcp) time required for administering the private facebook chat group, and through e-mail/private message support. 7. quantify researcher time required for cleaning and analysis of app data.

Eligibility criteria:
inclusion criteria: * female * age 18-35 years * live in the uk * moderate or high risk of bc (see 6.5 for definition) * ability to communicate in english * ability to download and use an app (available on both ios and android) exclusion criteria: * previous bc (other cancers will not be excluded) * previous preventative mastectomy * currently trying to gain weight * previous weight loss surgery * currently taking weight loss medication, prescribed (for example orlistat, liraglutide, naltrexone/bupropion \[mysimba\]) or other * have a medical condition that influences diet and weight, for example, diabetes, inflammatory bowel disease or cystic fibrosis * current diagnosis of a psychiatric disorder, for example bipolar psychotic disorder or current self-harm * current alcohol or drug dependency * current or previous diagnosis of an eating disorder
dapsone prurigo study

Conditions: Lichen Simples Chronicus and Prurigo

Summary: principal aim of this study is to assess whether a combination of topical dapsone and clobetasol as a topical steroid is superior to clobetasol alone as treatment of prurigo nodularis or lichen simplex chronicus in a side to side comparison. the study is primarily exploratory and essentially meant to inform the sponsor whether further development of a combination treatment formulation is warranted


Eligibility criteria:
inclusion criteria: * • active prurigo nodularis or lichen simplex chronicus - diagnosed by clinical exam * for lichen simplex chronicus patients: severity of maximum pruritus in the last 24 hrs at least 5 out of 10 on a visual analogue scale. * for prurigo nodularis patients: excoriations or signs of other scratch related activity at presentation to demonstrate active disease * symmetrical disease/excoriations allowing for a side-by-side comparison (eg, bilateral lichen simplex chronicus or bilateral prurigo nodularis) - genitals, face, axillae or neck cannot be used for side-to-side comparison * willing to refrain from use of all other topical medications in the treatment areas. * able and willing to provide written informed consent * willing and able to understand and comply with the requirements of the study, apply the treatment combinations as instructs, attend required study visits, comply with study prohibitions and able to complete the study. * male or non-preganant, non-lactating female between 18 and 75 years of age, inclusive * for females of child-bearing potential, willing to use adequate birth control during the study conduct exclusion criteria: * • history of non-compliance with follow up visits * should we exclude failure to certain treatments as an exclusion criterion? patients who failed oral dapsone should be excluded * presence of any skin condition on the treatment areas that would interfere with the diagnosis or assessment of active lichen simplex chronicus and/or prurigo nodularis (eg, rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis or bacterial folliculitis) * excessive hair in the treatment area that would interfere with diagnosis or assessment of lichen simplex chronicus and/or prurigo nodularis * history of hypersensitivity or allergy to topical steroids, dapsone, or any other treatment product components * use of tanning booths, sunbathing or excessive exposure to the sun during the study * consumes excessive amount of alcohol, abuses drugs, or has any condition that would compromise compliance with this protocol

Keywords: lichen simplex chronicus prurigo
effect of hepatitis c clearance on insulin resistance

Conditions: Insulin Resistance; Hepatitis C

Summary: chronic hepatitis c infection has been linked to insulin resistance, which is the essential component of metabolic syndrome and type 2 diabetes mellitus. resistin; an adipokine, has been demonstrated to stimulate the secretion of several inflammatory factors known to play a role in the induction of insulin resistance. we investigated the changes in insulin resistance after hepatitis c clearance in the era of direct antivirals.

the link between hepatitis c infection and insulin resistance has been established. insuli resistance has been linked to poor response to interferon based therapy. recently, direct acting antiviral drugs are approved for hepatitis c elimination with high potency and safety. the aim of the study is to: 1. determine the prevalence of insulin resistance among non-diabetic patients with chronic hcv infection. 2. explore the impact of treatment with daas on insulin resistance among chronic hcv infected patients. 3. investigate the role of insulin resistance as a potential prognostic factor for the response to daas. 4. explore the utility of resistin as a potential biomarker ir among hcv infected patients.

Eligibility criteria:
inclusion criteria: * hepatitis c treatment-naïve; * non-diabetic patients. exclusion criteria: * seropositivity for hepatitis b virus infection; * diabetes mellitus; * bbody mass index ≥ 30 kg/m\*2; * history of alcohol consumption; * endocrinopathies that may affect the glycemic homeostasis; * other known causes of chronic liver disease; hepatic decompensation \[defined as history of gastrointestinal bleeding (melena and /or hematemesis), jaundice, coagulopathy, hepatic encephalopathy, and/or ascites\]; bleeding diathesis; * connective tissue diseases; * autoimmune diseases; * cardiac, respiratory or renal disease. * patient receiving immuno-modulatory therapy or drugs that affect the blood glucose levels such as steroids or beta-blockers.
staged and combined surgery for cataract patients with corneal endothelial dysfunction

Conditions: Cataract; Corneal Endothelial Keratopathy; Phacoemulfisication+IOL Implantation; Endothelial Keratopathy

Summary: the purpose of this study is to evaluate the safety and efficacy of staged and combined phacoemulsification with intraocular lens implantation and descemet membrane endothelial keratoplasty (dmek) to treat cataract patients with corneal endothelial dysfunction. surgical and postoperative complications, visual acuity and corneal endothelial cell density are evaluated.

the prospective, randomized, controlled study involves the enrollment of cataract patients with corneal endothelial dysfunction. all the patients will be randomly assigned with equal probability to the following two groups: 1. staged group: phacoemulsification + iol implantation is performed individually and dmek is performed secondarily according to the corneal status of patients. during cataract surgery, viscoelastic materials and anterior lens capsule are used to protect the compromised corneal endothelium during phacoemulsification. after phacoemulsification and removal of all the lens material, a one-piece foldable iol is implanted into the lens capsule. 2: combined group: phacoemulsification + iol implantation and dmek is performed simultaneously. standard procedures of phacoemulsification + iol implantation are the same as in the staged group. patients enrolled into the study will be followed for one year and will have study visits at 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months and 12 months after each surgery.

Eligibility criteria:
inclusion criteria: 1. subjects are older than 18 years. 2. subjects have corneal endothelial dysfunction combined with cataract. 3. subjects have mild to moderate cortical and/or nuclear cataract. 4. subjects are able and willing to provide informed consent. exclusion criteria: 1. subjects have corneal stromal opacity and/or neovascularization. 2. subjects have other intraocular disease that disturbs visual rehabilitation. 3. subjects have corneal infection, perforation or scarring. 4. subjects are pregnant. 5. subjects have concurrent disease that could confound the response to therapy. 6. subjects are unlikely to comply with the protocol or likely to be lost to follow-up. 7. subjects have known hypersensitivity or intolerance to the proposed therapy. 8. subjects use concomitant therapy that affects either tear function or ocular surface integrity. 9. subjects have had surgical or other manipulation of the eye that could confound the outcome parameters or interfere with the mechanism of action of the proposed intervention to be studied.
saving mother and baby with text messaging

Conditions: Bleeding; Infection; Malnutrition; Complications

Summary: we plan to integrate who educational material using mobile phone text messaging, target on pregnant women in remote rural areas in china. we hypothsized that text messaging can have major impact on reducing maternal and infant deaths in rural china because text messaging is accessible, acceptable, and affordable.

1. sampling method: random sampling method will be used. counties in huaihua area of chinese province of hunan will be randomly allocated to intervention and non-intervention groups. 2. the intervention: mobile phone text messages containing maternal and newborn health care education material will be sent to mothers-to-be at the first, second and third trimester, and again postpartum period. 3. statistical analysis: we will first compare the baseline characteristics (including the average income, adult educational level, and maternal and perinatal mortality rates in the past two years) between the 2 arms of experiment. for costs data, total costs, costs per participating woman, and costs per maternal/infant death avoided will be reported. for primary outcomes, we will determine and report rate ratios, risk differences, and numbers needed to treat (nnt) from the experimental arm (i.e., mobile phone text messaging), using the usual care arm (no text messaging) as the reference. relative risks and 95% confidence intervals will be expressed as the effect measures. we will estimate the adjusted relative risks and 95% confidence intervals by regression analysis. mixed models taking consideration of multi-level measures (e.g., mortality and morbidity measured at individual level and intervention measured at village level) will be used in the regression analysis (donner and klar, 2000).

Eligibility criteria:
inclusion criteria: * women who were registered by local maternal child health unit during the study period exclusion criteria:

Keywords: mobile phone text messaging maternality infant death rate
misoprostol for the treatment of postpartum hemorrhage

Conditions: Postpartum Hemorrhage

Summary: the purpose of this study is to test whether misoprostol is as effective as oxytocin for treating primary postpartum hemorrhage (pph) with uterine atony as the suspected cause in two circumstances: 1) where women have received prophylactic uterotonics in the third stage of labor; and 2) where no prophylactic uterotonics have been given in the third stage of labor.

postpartum hemorrhage (pph) remains a major cause of maternal deaths worldwide. misoprostol offers several advantages over oxytocin and ergometrine, the drugs currently used to treat pph. for example, misoprostol is stable at high temperatures and has a shelf life of several years, it is easy to administer, it can be given to hypertensive patients, and it is inexpensive. this randomized, double-blind placebo-controlled trial will test whether misoprostol is as effective as oxytocin in treating primary pph in hospital births, both when women have received prophylactic uterotonics in the third stage of labor and when they have not. blood loss will be measured for all consenting women who deliver vaginally. if pph occurs and uterine atony is the suspected cause, women will be randomized to receive either: a) four 200 µg pills of misoprostol sublingually and an iv of saline (resembling oxytocin) or b) four placebo tablets resembling misoprostol sublingually and 40 iu oxytocin by iv. this study seeks to answer the following questions: * is misoprostol as effective as oxytocin for treatment of primary pph for women who do and do not receive oxytocin prophylaxis in the third stage of labor? * does misoprostol have an acceptable safety profile when given as an 800 µg sublingual dose to treat pph? * is the side effect profile of misoprostol acceptable to women? this study will take place in hospitals located in burkina faso, ecuador, egypt, turkey, and vietnam.

Eligibility criteria:
inclusion criteria: * vaginal delivery * postpartum hemorrhage due to suspected uterine atony * depending on study group: administration of prophylactic uterotonics in third stage of labor exclusion criteria: * known allergy to misoprostol or other prostaglandin * c-section for current delivery

Keywords: postpartum hemorrhage misoprostol developing countries maternal morbidity randomized controlled trial
effect of soy phytoestrogens and acupuncture on bone mineral density in female athlete triad at adolescence age

Conditions: Osteoporosis, Osteopenia

Summary: the aim of this study to determine the effect of soy phytoestrogens and acupuncture on osteoporosis in female athlete triad at adolescence age. it is hypothesized that: - there will be no statistical significant difference between the effects of soy phytoestrogens and acupuncture on osteoporosis in female athlete triad at adolescence age. research question: do soy phytoestrogens and acupuncture have an effect on bone mineral density in female athlete triad at adolescence age?

many female athletes don't depend only on physical training and exercising to obtain the ideal slim and thin body. so that they follow harmful unhealthy diet to achieve the ideal body shape they are seeking. these types of diet can lead to malnutrition, menstrual disturbances, and bone loss, and these three components form a triad called female athlete triad. a limited number of studies have examined the effect of acupuncture and soy products on irregularities related to female athletes so the aim of this study is to investigate the effect of both acupuncture in line with diet modification using soy products on osteopenia in female athlete triad. study design: a prospective, randomized, single-blind, pre-post-test, controlled trial. sixty female athletes with ages ranged from 14 to 18 years, playing gymnastics and all diagnosed and referred with female athlete triad resulting in decreased bone mineral density and osteoporosis. all participants will be treated with soy products and acupuncture and will be closely followed for six months. dexa will be used to assess bone mineral density before and after the treatment program.

Eligibility criteria:
inclusion criteria: all girls diagnosed with female athlete triad resulting in osteopenia * their age between 14-18 years old * their body mass index is less than 5 percent according to the gross motor chart * all participants are gymnastics players * all are medically stable * they will be able to follow instructions exclusion criteria: * marriage * pregnancy * taking any hormonal treatment * receiving any other form of traditional physical therapy modalities

Keywords: female athlete triad
a study of prp treatment for hair loss after cancer therapy in women with breast cancer

Conditions: Alopecia

Summary: participants who enroll in this study will undergo the platelet-rich plasma (prp) study treatment. participants will have a sample of blood collected and the platelets will be separated and then injected into half of the participants' scalp every 4 weeks for 12 weeks.


Eligibility criteria:
inclusion criteria: * women ≥ 18 years of age * have a clinical diagnosis of endocrine therapy induced alopecia (eia) for breast cancer: * selective estrogen receptor modulators (tamoxifen, toremifene) * aromatase inhibitors (anastrozole, letrozole, exemestane) * gonadotropin-releasing hormone agonist (leuprolide) or * must have a clinical diagnosis of chemotherapy induced (pcia) alopecia with incomplete or absent regrowth of hair \> 3 months after completion of chemotherapy without use of endocrine cancer-related therapy (et) within the last 6 months * ludwig stage 1-3 for women * if patient has a history of use of topical minoxidil and/or systemic spironolactone for alopecia for at least three consecutive months, then a 3 month washout is required prior to start of treatment * completed informed consent form exclusion criteria: * patients who are pregnant or breastfeeding * history of hair transplantation * use of any cosmetic product aimed at improving or correcting the signs of hair loss within 2weeks prior to screening. note: patients are not permitted to use any hair loss products during the study. * an active scalp dermatologic condition (e.g. alopecia areata, scalp psoriasis), scalp skin cancer (e.g. bcc, scc), a pre-existing condition with sequelae on the scalp (e.g. scarring alopecia) or acute infection. * hereditary or acquired hematologic/coagulation disorders such as: platelet dysfunction syndrome, critical thrombocytopenia (platelet count \<150,000 platelets/ul),hypofibrinogenemia, impaired coagulation, drepanocytosis (sickle cell anemia). * actively receiving anticoagulant medication * patients taking aspirin or other nsaids such as nurofen, voltaren, diclofenac or naproxen, or fish-oil supplements because of its anti-platelet activity, can participate, provided medication is interrupted 7 days before beginning of the treatment. * planned or previous radiation therapy to the brain * vulnerable populations e.g. decisionally impaired (cognitive, psychiatric) or patients who, in the opinion of the investigator have a condition that precludes their ability to provide an informed consent * patients taking hair supplements, such as biotin or biosil, can participate, provided hair supplements are washed out 3 months prior to beginning of treatment.

Keywords: endocrine therapy induced alopecia eia chemotherapy induced alopecia pcia memorial sloan kettering cancer center 20-133
synergy between pci with taxus and cardiac surgery: syntax extended survival

Conditions: Coronary Artery Disease

Summary: an investigator-driven, retrospective study to compare long-term survival-data (10-year follow-up) of patients with coronary artery disease (cad), previously enrolled in the syntax trial, who were randomized to percutaneous coronary intervention (pci) using a paclitaxel (taxus) drug-eluting-stent (des) or coronary artery bypass grafting (cabg).


Eligibility criteria:
patients which have previously been enrolled in the syntax trial (randomized and registry patients)

Keywords: coronary artery bypass grafting percutaneous coronary intervention drug eluting stent survival status long-term follow-up complex coronary artery disease