Kornimate/medical-research-clean huggingface dataset:
post approval pharmacokinetic study of loratadine in japanese pediatric and adult patients (study p05539)

Conditions: Perennial Allergic Rhinitis

Summary: this is a post marketing study to confirm the appropriate dose of loratadine in children by obtaining drug concentration data at multiple time points per child and adult patient, after the patient receives repeated administrations of the approved dose of loratadine.


Eligibility criteria:
inclusion criteria: patients with perennial allergic rhinitis who satisfy all of the following criteria were enrolled in the study: * pediatric patients between the ages of 3 and 15 years and adult patients between the ages of 16 and 64 at the time of providing informed consent. * outpatients of either sex. * pediatric patients for whom written informed consent can be obtained from the guardian before the start of the study. adult patients from whom written informed consent can be obtained (for patients between the ages of 16 and 19, the guardian must also provide written informed consent). * pediatric patients who have the ability to make entries in the patient diary (record of drugs and nasal symptoms) or entry in the diary is made possible by the guardian. adult patients who have the ability to make entries in the patient diary. * patients for whom treatment with loratadine monotherapy is judged appropriate based on symptoms of allergic rhinitis during the pretreatment observation period. * patients confirmed to be allergic to perennial allergen exclusion criteria: * patients with a history of epileptic seizures or organic brain disorder in whom there is a possibility that epileptic seizures may be induced * patients with a history of hypersensitivity to any component of this drug * patients who are pregnant or who may be pregnant, and nursing women * patients with severe hepatic, renal, cardiac, or hematological disease or other serious complications and whose general condition is poor * patients participating in another clinical study or who have been in a clinical study within the last 30 days. * other patients judged inappropriate for study by the investigator or sub-investigator * patients allergic to pollen (cedar, mugwort, common ragweed, orchard grass, etc.) and the pollen season is during the period from 7 days before registration to the end of study drug administration * patients who developed diseases which might affect nasal symptoms (acute upper respiratory tract infection, acute pharyngo-laryngitis, or acute tonsillitis) in the 7 days before registration * patients who received treatment for allergic rhinitis in the 7 days before registration
unwinding anxiety for migraine: pilot

Conditions: Migraine; Anxiousness

Summary: this is a pilot study that aims to understand the feasibility and acceptability of a mobile health educational app plus group-based mindfulness therapy on anxiety and migraine-related disability among people with migraine.


Eligibility criteria:
inclusion criteria: * 18 or older * meets diagnostic criteria for migraine * reports anxiety symptoms of 5 or more on gad-7 * has a smartphone exclusion criteria: * under the age of 18 * presence of suicidal ideation * reports severe depression on phq-9 * lack of group readiness
sunscreen rv 2457c in photoinduced cle

Conditions: Cutaneous Lupus Erythematosus; Skin Lesion; Experimental Photoinduction; Protective Sunscreen

Summary: lupus erythematosus (le) is characterized by a large clinical spectrum, and sunligt is a well established factor in the induction and exacerbation of this disease. in all subsets of le, skin lesions occur preferentially in sun-exposed areas. previous studies have demonstrated that the lesions in le patients reproduced in controlled experimental conditions. the initial reports suggested that the action spectrum for the le was in the uvb range (290 to 320 nm), but more recent studies have demonstrated that uva (320 to 400 nm) can contribute to the induction of le skin lesions. antimalarial agents and topical steroids are the main treatments of chronic le. the second line therapies include retinoids, sulfones, immunosuppressor agents, systemic corticosteroid and thalidomide. moreover, patients are advised to avoid sun, to wear sunprotective clothing and to apply sunscreen. the aim of this study was to assess the efficacy of a sunscreen milk with high protection factor against uv-b and uv-a, used exclusively, in the photoinduced le.


Eligibility criteria:
inclusion criteria: * male or female subjects * patient aged of 18 years or more * documented medical history of chronic cutaneous lupus erythematosus (lupus erythematosus tumidus, discoid lupus erythematosus, subacute lupus erythematosus) without any sign of systematic involvement * patients who have a history of positive provocative phototestimg using a standardized protocol during a previous photobiologic exploration * informed consent exclusion criteria: * pregnant women, nursing mothers * subjects with lupus erythematosus with systematic involvement * subjects with a medical history of another photodermatosis * subjects with sun erythema, residual pigmentation, dermatological lesion, abnormal skin pigmentation which might interfere with a study evaluation on test sides * subjects who had sun solar simulator exposure on their backs within 12 weeks prior to enter to the study * subjects with a known intolarance to one of the formula compounds

Keywords: cutaneous lupus erythemaosus photoprotection photoprovocation sunscreen rv 2547c
the effect of blood flow rate on dialysis recovery time in patients undergoing maintenance hemodialysis

Conditions: ESRD; Fatigue; Hemodialysis-Induced Symptom

Summary: a majority of patients with end-stage renal disease (esrd) on in-center hemodialysis (hd) require several hours to recover from fatigue after an hd session. evidence for practical interventions to improve this recovery time from conventional in-center hd is lacking. this study investigates the effects of reducing hd blood flow rates on patients' self-reported post-dialysis fatigue.

post-dialysis fatigue reduces patients' quality of life and is also associated with cardiovascular events and mortality. dialysis recovery time (drt) is a measure of post-dialysis fatigue. internationally, it has been found that more than a quarter of maintenance hd patients report \>6 hours of drt. the interventions showing the most improvement in drt involve increases in treatment time, suggesting that post-dialysis fatigue may be in part related to the rate of solute clearance. solute clearance rate is just one part of extending dialysis time, and its effect on drt in patients undergoing typical-length dialysis sessions is not known. there is scant evidence to guide blood flow rate prescriptions aside from meeting clearance targets. blood flow rate reductions are easily-implementable interventions that would slow solute clearance rates and may have an effect on post-dialysis fatigue.

Eligibility criteria:
inclusion criteria: * a diagnosis of end-stage renal disease undergoing hemodialysis in the san francisco bay area at approved satellite healthcare dialysis centers. * dialysis recovery time of 6 or more hours. * not hospitalized in the 7 days prior to study exclusion criteria: * currently or possibly pregnant, currently trying to become pregnant * inability to provide informed consent * inability to provide responses to survey questions * planned move away from the current hemodialysis center within the study period * undergoing nocturnal hemodialysis, planned changed to nocturnal or peritoneal dialysis, planned kidney transplant within the study period, or other major planned change in hemodialysis prescription * primary nephrologist objection to enrollment

Keywords: patient-reported outcomes post-dialysis fatigue dialysis recovery time
association between iron reserves and perioperative neurocognitive disorders

Conditions: Perioperative Neurocognitive Disorders

Summary: iron metabolism disorder have been identified as the pivotal contributor in the pathogenesis and progression of perioperative neurocognitive disorders. however, the association between iron reserves and perioperative neurocognitive disorders risk remains elusive. this retrospective cohort study aimed to explore the impact of preoperative serum ferritin levels on the risk of postoperative delirium in elderly patients undergoing non-neurosurgical and non-cardiac procedures.


Eligibility criteria:
inclusion criteria: * geriatric surgical patients ≥65 years old exclusion criteria: * preoperative use of antipsychotics * diagnosis or history description of preoperative cognitive disorders including dementia and parkinson's

Keywords: iron reserves perioperative neurocognitive disorders elderly iron overload
reinforcing effects of marijuana and opioids

Conditions: Marijuana Use; Opioid Use

Summary: the primary goals of this study are to examine 1) marijuana modulation of oxycodone self-administration and 2) oxycodone modulation of marijuana self-administration, under controlled conditions and across a range of doses for each drug.


Eligibility criteria:
inclusion criteria: * ages 18-50 * experience with marijuana and opioids * general good health * willing to live at the university of kentucky hospital (research unit) for approx. 6.5 weeks (meals are provided, exclusion criteria: * significant medical complications/conditions

Keywords: marijuana opioid healthy participants laboratory study
effects of delivery mode of cognition intervention in early alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to see if an intense two-week long cognitive training program helps the thinking ability of adults with very mild alzheimer disease. we anticipate that scores on clinical cognitive tests will be better after the training.

twenty of the 30 subjects will be recruited to participate in functional magnetic resonance imaging (fmri). scanning will be done while subjects perform a verbal learning task. ten subjects will be scanned before and after the two week training. another ten will be scanned twice at a two week interval before beginning the cognitive training.

Eligibility criteria:
inclusion criteria: * diagnosis of very mild alzheimer's disease (cdc of 0.5) and mild alzheimer's disease (cdc of 1.0) exclusion criteria: * neurologic disorder other than alzheimer's disease

Keywords: alzheimer's disease cognitive training
an open label study to allow patients continuous use of the hemocare™ hemodialysis system

Conditions: End Stage Renal Disease

Summary: this study is designed to monitor and assess the safety of continued access to the hemocare™ hemodialysis system used during the review of the pre-market notifications for the devices in the hemocare™ hemodialysis system.


Eligibility criteria:
inclusion criteria: * completed deka protocol dkpl 00057 001 and are qualified to enter the study based on the assessment of the investigator. * are willing to comply and capable of complying with the study requirements for therapy with the hemocare™ hemodialysis system. * have a trained study care partner able to support subject for all at-home study treatments. * subject and care partner can read and understand english and provide written informed consent. * have a stable functioning vascular access as judged by the treating physician. exclusion criteria: * have a current self-reported pregnancy or are actively planning to become pregnant within the next 12 months, lactating, or not using medically acceptable means of contraception during the study. * have any any other clinically significant medical disease or condition or subject responsibility that, in the investigator's opinion, may interfere with a subject's (and/or care partner's) ability to give informed consent, adhere to the protocol, interfere with assessment of the investigational product (ip), or serve as a contraindication to the subject's participation in the study. * have a significant psychiatric disorder or mental disability that could interfere with the subject's ability to provide informed consent and/or comply with study procedures. * are participating or planning to participate in any other interventional studies except dkpl-00057-001.

Keywords: hemocare™ hemodialysis system hemocare™ hemodialysis
effects of the hypopressive exercises in women with pelvic organ prolapse

Conditions: Pelvic Floor Disorders; Prolapse; Female

Summary: the aim of this study was compare home-based pelvic floor muscle training (pfmt) alone and home-based pfmt combined with hypopressive exercise (he) in terms of pelvic floor muscle (pfm) activation and severity of pelvic floor dysfunction (pfd) in women with pelvic organ prolapse (pop) for eight weeks. for this purpose, the participants were randomly divided into two groups: \[pfmt alone (n:15) and pfmt combined with he(n:17)\]. duobravo emg device for evaluation of pfm activation and "pelvic floor distress inventory-20" was used to evaluate the severity of pfd. all evaluations were performed twice in total, at baseline and at week 8.

pelvic floor muscle training (pfmt), which provides increased structural support of the pelvic organs by improving the functional strength, endurance and coordination of the pelvic floor muscles (pfm), has been a grade a recommendation based on level 1 evidence to improve symptoms and stages of pelvic organ prolapse (pop). on the other hand, hypopressive exercises (he) are a group of exercises that, when applied, relax the diaphragm, activate the abdominal muscles, activate the transversus abdominis muscle by reducing intra-abdominal pressure, thus providing reflex activation in the pfm, and are known to improve urinary incontinence and pop with these features. although there are studies investigating the effects of both exercise groups on pop, the results of the studies are contradictory and more research is needed on this subject.for this reason, in this study, the investigators aimed to compare home-based pfmt alone and home-based pfmt combined with he in terms of pfm activation and severity of pelvic floor dysfunction in women with pop for eight weeks.

Eligibility criteria:
inclusion criteria: * having been diagnosed with pop according to pelvic organ prolapse quantification system by a gynecologist; * being literate * being between 20-50 years exclusion criteria: * pregnancy; * having a cooperation problems; * history of active cancer; * finding an urinary infection during evaluation; * being in the menstrual period during the evaluation; * neurological, orthopedic or serious medical conditions that may affect the patient's pelvic floor functions.
the efficacy of ayurved siriraj prasaplai for treatment primary dysmenorrhea

Conditions: Primary Dysmenorrhea

Summary: ayurved siriraj prasaplai is a thai traditional herbal drug for pain treatment. mostly it was used for antipain during menstruation or dysmenorrhea. this drug has been described by alternative medical doctor for treatment of primary dysmenorrhea for more than 10 years and showed clinical satisfied response. from review about this agent, it does not have clinical trial to prove its efficacy. so the author produce this research to study in efficacy of ayurved siriraj prasaplai.

the participants were allocated in the study by block randomization and double blind. in experiment-group was treated with ayurved siriraj prasaplai and control-group was treated with placebo (non-active agent). both of drug was made in the same appearance of capsule (size and color). the participants have to start the drug when they have menstruation after that the dosage is 2 capsules for 3 times per day (after-meal) continue to 3 days. the participant have to record pain score (minimal/maximal/mean score) and multidimensional score in daily card, side effect and satisfaction. if the participant couldn't tolerate the pain, they could break the pain with mefenamic acid. they have record number of mefenamic acid which they used too. this study evaluate in only one cycle. after complete record, the participant come back to investigator for sending the report.

Eligibility criteria:
inclusion criteria: * woman who is diagnosed of primary dysmenorrhea. * woman who has regular menstruation. * woman who has numeric rating score for pain during menstruation (dysmenorrhea) more than score 5 and continuous for 3 menstrual cycle. * woman who want to participate in this study. exclusion criteria: * woman who has allergic history for herbal or other components in ayurved siriraj prasaplai drug. * woman who has hormonal contraception. * woman who has other diseases which is caused of abdominal pain. * breast feeding woman

Keywords: ayurved siriraj prasaplai primary dysmenorrhea
bowel function after minimally invasive urogynecologic surgery

Conditions: Functional Disorder of Intestine

Summary: the purpose of this study is to assess the effect of a standardized postoperative bowel regimen of over-the-counter medications in subjects undergoing minimally invasive urogynecologic surgery.

see above

Eligibility criteria:
inclusion criteria: * planning to be admitted to the hospital to undergo minimally-invasive urogynecologic surgery at strong memorial hospital. procedures may include: * robot-assisted laparoscopic sacrocolpopexy * sacrospinous ligament suspension * uterosacral ligament suspension/paravaginal defect repair * colpocleisis * cystocele repair additional procedures may include: * hysterectomy * adnexectomy * culdoplasty * minimally invasive sling procedure (tvt or tot) * periurethral collagen injections * enterocele repair exclusion criteria: * planning to undergo laparotomy. * undergoing rectocele or perineocele repair as part of surgery. * taking miralax, laxatives, enemas, or suppositories daily, at the time of enrollment. * presence of a colostomy. * chronic kidney disease * insulin-dependent diabetes mellitus * known cardiac disease * gastric ulcers * difficulty swallowing or esophageal stricture * persistent nausea and vomiting * signs and symptoms consistent with bowel obstruction

Keywords: urogynecology
accelerated corneal cross-linking with different riboflavin solutions

Conditions: Keratoconus

Summary: following the bunsen-roscoe law, accelerated cross-linking protocols with higher irradiation intensities and shorter irradiation times have been introduced. in addition, new riboflavin solutions with hpmc (hydroxylpropyl methylcellulose) instead of dextran found its way into cxl-treatment. the aim of this trial is to evaluate clinical outcomes in an accelerated corneal collagen cross-linking protocol with different riboflavin solutions.


Eligibility criteria:
inclusion criteria: * progressive keratoconus * indication for treatment * preoperative pachymetry \> 400 exclusion criteria: * pregnancy * re-cxl * keratitis * other visual acuity limiting eye diseases than corneal ectatic diseases
incidence of unresectable cases of cervical cancer

Conditions: Cervical Cancer

Summary: objective : to calculate the incidence of unresectable cases of cervical cancer in gyne-oncology unit of alexandria university hospital and to indentify its relation to pathological types, grading and lymph vascular space invasion. patients and methods: 70 cases of cervical cancer diagnosed by biopsy taking and histopathological examination will be included in the study, clinicoradiological staging was done to all cases to calculate the incidence of unresectable cases and to indentify its relation to pathological types, grading and lymph vascular space invasion


Eligibility criteria:
inclusion criteria: * cervical cancer exclusion criteria: none -
laparoscopic cryoablation of uterine fibroids

Conditions: Symptomatic Uterine Fibroids

Summary: the goal of this study is to evaluate the safety \& efficacy of cryoablation using icecure medical's icesense3™ device for the treatment of symptomatic uterine fibroids in a percutaneous lap-assisted approach.


Eligibility criteria:
inclusion criteria: 1. pre-menopausal woman between the ages of 30 and 50 (inclusive) 2. patient had completed her family planning and does not desire future childbearing. 3. patient is suffering from menorrhagia as a result of symptomatic uterine fibroids. 4. patient's uterus size is smaller than 18 gestational weeks. 5. patient wishes to preserve her uterus and avoid hysterectomy. 6. patient has 1-3 treatable uterine fibroids in size of up to 10cm measured by us/mri. 7. overall treated fibroid volume is ≤ 3,138cm3 (width x length x height x 0.523) 8. patient has clinical menorrhagia as indicated by menstrual blood loss of ≥160 ml during one baseline cycle prior to treatment. 9. patient is able to visit the clinic as needed during the 1 year follow-up period following the treatment. 10. the patient has been informed of the study and agrees to its provisions, and has signed an irb approved written informed consent, including data privacy authorization. exclusion criteria: 1. patient had not finished her family planning 2. patient was already treated for uterine fibroids in the past (uae, myomectomy, hifu,...) or undergone endometrial ablation. 3. patient had been treated with gnrh over the last 3 months. 4. patient has known symptomatic endometriosis that cannot be completely removed during laparoscopic procedure. 5. patient has known or suspected adenomyosis 6. patient had any active abdominal/pelvic inflammatory disease. 7. patient has known or suspected gynecologic malignancy. 8. patient with submucosal fibroids type "zero" 9. patient with undiagnosed vaginal bleeding 10. patient with blood clotting disorders 11. patients carrying contagious diseases such as tuberculosis hepatitis or aids. 12. patient participating in other trials using drugs or devices. 13. patient is unable to commit all study requirements including follow-up visits and questionnaires. 14. patient has any contraindication for laparoscopic surgery

Keywords: cryoablation uterine fibroid uterine myoma who completed her family planning but wishes to preserve her uterus
a study evaluating the effect of vitamin d on clinical outcome in autistic children

Conditions: Autism

Summary: the purpose of this study to determine whether high dose vitamin d has positive effect on behavior of autistic children.

double blinded placebo controlled study to determine effect of two different doses of vitamin d on behavioral domains in autistic children.

Eligibility criteria:
inclusion criteria: * patients fulfill fourth edition of diagnostic and statistical manual of mental disorders (dsm 4th) criteria for autism exclusion criteria: * patients who had seizures within the past year or history of kidney or liver disease or taking the following medications or supplements that may affect vitamin d level (as antiepileptic, corticosteroids or immunosuppressant) were excluded from the study. none of the study participants received vitamin d or calcium therapy in the past 6 months and there were no change in children's treatment regimen (including medications) within 1 month prior to the study.