Kornimate/medical-research-clean huggingface dataset:
impact of food on pharmacokinetics and pharmacodynamics of asasantin er in healthy subjects

Conditions: Healthy

Summary: comparative pharmacokinetics and pharmacodynamics of asasantin er at fasted and fed state


Eligibility criteria:
inclusion criteria: * healthy subjects as determined by results of screening * signed written informed consent in accordance with good clinical practice (gcp) and local legislation * age ≥ 18 and ≤ 55 years * broca ≥ - 20 % and ≤ + 20 % exclusion criteria: * any findings of the medical examination (including blood pressure, pulse rate and ecg) deviating from normal and of clinical relevance * gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * surgery of the gastro-intestinal tract (except appendectomy) * diseases of the central nervous system (such as epilepsy) or psychiatric disorders * chronic or relevant acute infections * history of hypersensitivity to asasantin er and any of the excipients * intake of drugs with a long half-life (\> 24 hours) (\< 1 month prior to administration or during the trial) * use of any drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial) * participation in another trial with an investigational drug (\< 1 month prior to administration or during the trial) * known alcohol abuse * known drug abuse * blood donation (\< 1 month prior to administration) * excessive physical activities (\< 5 days prior to administration) * history of hemorrhagic diatheses * history of gastro-intestinal ulcer, perforating or bleeding * history of bronchial asthma * any laboratory value outside the normal range of clinical relevance female subjects: * pregnancy * positive pregnancy test * no adequate contraception (adequate contraception e.g. sterilization, intrauterine devices (iud), oral contraceptives) * inability to maintain this adequate contraception during the whole study period * lactation period
a clinical study to evaluate the safety of a personal lubricant in healthy female subjects

Conditions: Erythema; Edema

Summary: to evaluate the safety of a personal lubricant when used at least four times weekly for two weeks (including at least twice weekly during sexual intercourse for subjects with monogamous male partners), in a population consisting of healthy females.


Eligibility criteria:
inclusion criteria: * no participation in a similar study 2-weeks prior * may be post-menopausal or have had a hysterectomy * if sexually active, and of child bearing potential, subjects is using adequate non-barrier method of birth control * free from any vaginal disorders * sexually active and in a monogamous, heterosexual relationship, and whose male partner is willing and able to give informed consent and agrees to engage in sexual intercourse at least twice each week during the two-week study or is not sexually active * personal lubricant user and agrees to replace her usual personal lubricant with the investigational product * can start regardless of where they are in their cycles * agrees to use the provided investigational product at least four time weekly over the two week study period * exhibits no clinically significant evidence of vulvar or vaginal irritation, as determined by a study doctor, and no reports of sensory irritation at the baseline exam * willing to refrain from introducing any new vaginal products, or using vaginal medications or local contraceptives during study * agrees to refrain from douching or using any medications, powder, lotions or personal care products in the vulvar or perianal area * willing to use a urine pregnancy test provided to them at baseline and on third visit * standard medical history form on file * signed informed consent * completed hipaa * dependable and able to follow directions as outlined * receives a score of 0 or 0.5 for erythema and edema; and 0 for sensorial irritation (burning, stinging, itching and dryness) during the first examination. exclusion criteria: * pregnant, nursing or planning a pregnancy * currently using or has used within two weeks prior to the study initiation, any systemic or topical corticosteroids, vasoconstrictors, antibiotics, anti-inflammatories or antihistamines * known allergies to vaginal or any cosmetic products * reports history of recurrent bladder, vaginal infections or incontinence * exhibits or reports gynecologic abnormalities or has had vaginitis within 60 days prior to study initiation * uses a vaginal ring, diaphram or cervical/vault caps, condoms, or condoms with spermicide as a means of contraception * participated in a study involving the vaginal area or in an investigational systemic drug study within two weeks of study initiation * receives a score higher than 0/5 for erythema, edema or \>0 for burning, stinging, or itching, during first examination or shows any other sign of mucosal irregularities
clinical effects of bacillus containing oral hygiene products on gingivitis: a randomized controlled trial

Conditions: Gingivitis

Summary: aim: evaluating the clinical effects of a bacillus subtilis, bacillus megaterium and bacillus pumulus containing toothpaste, mouthwash and toothbrush cleaner versus a placebo in patients with generalized gingivitis. materials and methods: in this double-blind placebo-controlled randomized clinical trial generalized gingivitis patients who were systemically healthy and who did not smoke were included. they used a placebo or probiotic bacillus containing toothbrush cleaner for 8 weeks. primary outcome measures of interest were plaque and gingivitis index, secondary outcome measures were pocket probing depth and bleeding on probing.

the administration of micro-organisms to improve the human health was already promoted by the nobel prizewinning scientist eli metchnikoff in the beginning of the 20th century. however, it took several decades for this subject to become a topic of interest in medicine. at this moment these micro-organisms are called "probiotics" and defined as "living microorganisms which, when administered in adequate amounts, confer a health benefit for the host" (http://www.who.int/foodsafety/publications/fs_management/en/probiotics.pdf). over the past decade probiotics have been extensively investigated from the perspective of oral health. it was shown that probiotics have the capacity to reduce mutans streptococci counts in saliva and/or plaque during their usage, that they have a positive influence on bad breath and that they can improve the results of scaling and root planing in periodontitis patients. a positive effect of probiotic usage on plaque accumulation and gingivitis measurements in gingivitis patients was also shown.to the investigators knowledge, at this moment no trials are available describing the effect of other probiotic genera on gingivitis. since it is clear that probiotic effects are strain, dosage and mode of application dependent, the aim of this study was to evaluate the use of a probiotic toothpaste, mouthwash and toothbrush cleaner with bacillus subtilis, bacillus megaterium, and bacillus pumulus versus a placebo in patients with generalized gingivitis.

Eligibility criteria:
inclusion criteria: * diagnosed with plaque-induced gingivitis * a pocket probing depth not more than 5 mm * at least 20 natural teeth * no history of periodontal therapy or previous use of antibiotics or anti-inflammatory medication within the preceding 6 months exclusion criteria: * patients with hematologic disorders, or other systemic illness * pregnant and lactating females * patients undergoing orthodontic treatment * those with smoking habits were excluded.

Keywords: gingivitis gingival inflammation probiotics bacillus
efficacy of stellate ganglion block in obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: the goal of this clinical trial is to test the efficacy of stellate ganglion block in obstructive sleep apnea. the main question it aims to answer are: • can stellate ganglion block improve obstructive sleep apnea? patients were randomly divided into two groups, all provided with routine therapy. based on this, the experimental group was given stellate ganglion block. the video fluoroscopic swallowing study was done to test the swallowing function before and after the study.

obstructive sleep apnea is of increasingly high prevalence. the goal of this clinical trial is to test the efficacy of stellate ganglion block in obstructive sleep apnea. the main question it aims to answer are: • can stellate ganglion block improve obstructive sleep apnea? patients were randomly divided into two groups, all provided with routine therapy. based on this, the experimental group was given stellate ganglion block. the video fluoroscopic swallowing study was done to test the swallowing function before and after the study.

Eligibility criteria:
inclusion criteria: * patients aged over 18 years diagnosed with osa by polysomnography * patients with moderate to severe osa (ahi \> 15 events per hour) * patients who have undergone continuous positive airway pressure (cpap) treatment for at least 3 months but have not achieved satisfactory therapeutic effects * patients who voluntarily agree to receive stellate ganglion block (sgb) treatment and sign the informed consent form exclusion criteria: * patients with a history of allergy or contraindications to local anesthetics or corticosteroids * patients with severe cardiovascular, cerebrovascular, respiratory, hepatic, or renal diseases * patients with a history of neck surgery or cervical spine disease * patients with psychiatric disorders or other medical conditions that may affect the safety or effectiveness of sgb treatment * pregnant or lactating women * patients who have participated in other clinical trials within the past 3 months
interferon alfa or no further therapy following surgery in treating patients with stage ii, stage iii, or recurrent melanoma

Conditions: Melanoma (Skin)

Summary: rationale: interferon alfa may interfere with the growth of the cancer cells. it is not yet known whether interferon alfa following surgery is more effective than surgery alone in treating patients with melanoma. purpose: randomized phase iii trial to compare the effectiveness of interferon alfa with no further therapy following surgery in treating patients with stage ii, stage iii, or recurrent melanoma.

objectives: i. determine the effects of adjuvant low-dose extended-duration interferon alfa on disease-free and overall survival in patients with completely resected malignant melanoma at high risk of recurrence. ii. determine any correlation between patient age or sex and the effects of interferon therapy on disease-free and overall survival. iii. describe the toxic effects of this treatment. iv. evaluate the economic implications of implementing effective interferon therapy in these patients. outline: this is a randomized study. patients will be stratified by age, sex, disease status at entry, and participating institution. patients are randomized to observation only or to receive interferon alfa by subcutaneous injections 3 times weekly for 2 years, or until disease progression or toxicity intervenes. patients are followed monthly for 6 months, quarterly for 18 months, and every 6 months thereafter. projected accrual: a total of 1,000 patients will be entered over 5 years.

Eligibility criteria:
disease characteristics: histologically confirmed malignant melanoma definitively resected within 12 weeks prior to entry one of the following categories: stage ii disease (greater than 4 mm breslow thickness) stage iii disease (regional lymph node involvement) recurrent non-nodal superficial regional disease (local or in transit) recurrent regional nodal involvement patient characteristics: able to tolerate interferon no second malignancy except curatively treated: carcinoma of the cervix nonmelanomatous skin cancer no pregnant or nursing women prior concurrent therapy: no prior immunosuppressive therapy, including systemic steroids no prior biologic therapy recovered from surgery

Keywords: stage ii melanoma stage iii melanoma recurrent melanoma
clinical application of portable intelligent multi joint isokinetic training and evaluation system technology

Conditions: Stroke; Hemiplegia; Rehabilitation; Tobacco Use; Physical Disability

Summary: the goal of this clinical trial is to compare in describeparticipant population. the main question it aims to answer is:by using intelligent portable isokinetic tester and traditional isokinetic tester, isokinetic knee flexor and extensor muscles of stroke patients with hemiplegia were trained respectively, so as to observe and compare the effects of the two treatment methods. in addition, the therapeutic effect of the above two treatments was compared with that of exercise therapy alone. participants will be divided into three groups: control group, intelligent isokinetic treatment group, and traditional isokinetic treatment group. participants of both the control group and the two treatment groups received exercise therapy. on the basis of exercise therapy, participants of the intelligent isokinetic treatment group used the intelligent portable isokinetic tester to train the affected knee flexion and extensor muscle, while the participants of traditional isokinetic treatment group used the intelligent portable isokinetic tester to train the affected knee flexion and extensor muscle.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of cerebral apoplexy's disease * confirmed by ct or mr examination of the head * first onset, duration ≤1 month * the lower extremity of the hemiplegic limb was above brunnstrom stage iii * must be able to sign the informed consent form exclusion criteria: * vital signs are unstable * severe cognitive, visual and hearing impairment * orthopaedic disease * muscle pain lower extremity * congenital disease * history of other encephalopathy * history of mental illness
a study to evaluate the effect of cimetidine on cd4 lymphocyte counts in hiv infection

Conditions: HIV Infections

Summary: to determine the change in cd4 count after 4 and 8 weeks in hiv-infected patients treated with cimetidine compared to placebo. to observe time-associated trends at weeks 4, 8, 12, and 16 in the change of cd4 counts for patients taking cimetidine for the full 16 weeks. to establish a safety record for cimetidine use in hiv-positive patients.


Eligibility criteria:
inclusion criteria: concurrent medication: allowed: * all fda-approved medications, antiretrovirals, and pcp prophylaxis drugs, with the exception of warfarin (coumadin). * other self-prescribed medications available either over the counter or through buyer's clubs. patients must have: hiv positivity. note: * patients on an antiviral or immunomodulating drug must have received it for at least 2 months and have no intention to make clinical or therapeutic changes in the first 8 weeks (such as adding a new agent or discontinuing effective viral suppressive therapy) that may interfere with the study. note: * patients who become pregnant after enrollment will be permitted to continue on study drug but must sign an additional informed consent indicating their awareness of the issues in taking a drug with limited safety data during pregnancy. prior medication: allowed: * antiviral and immunomodulating drugs, provided patient has been on such therapy for at least 2 months prior to study entry. exclusion criteria: co-existing condition: patients with the following symptoms or conditions are excluded: * known intolerance or hypersensitivity to cimetidine. * evidence of active opportunistic infection or malignancy requiring high-dose systemic chemotherapy. * any symptoms suggestive of concurrent illness that are not attributable to overall impairment by hiv or are not diagnosable based on the available evidence. * inability to swallow tablets (gastric feeding tubes are allowed). * not willing to comply with visit schedule and study procedures. concurrent medication: excluded: * warfarin (coumadin). prior medication: excluded within 4 weeks prior to study entry: * cimetidine (tagamet), ranitidine (zantac), famotidine (pepcid), and nizatidine (axid).

Keywords: acquired immunodeficiency syndrome aids-related complex cimetidine
primary care transition study

Conditions: Chronic Health Condition; Cognitive Disability

Summary: this study is looking at ways to help young people with chronic health conditions take better care of their health and find an adult doctor.

the purpose of this study is to determine whether providing targeted transition-related skills through interventions with varying degrees of intensity (from the low intensity basic intervention group, to the mild intensity group intervention group, to the high intensity full intervention group) results in improved transition readiness and self-care skills and improved successful transition to adult-based services for young adults with chronic health conditions. secondary objectives include determining if the transition interventions enhance transition-related satisfaction among participants, their caregivers and the involved pediatric and adult providers.

Eligibility criteria:
young adult inclusion criteria: * males or females age 19 years of age or older * presence of at least 1 chronic condition and/or cognitive disability * last visit with pediatric primary care provider occurring on or after january 1, 2011 * currently active in one of four identified pediatric practices (cobbs creek, chestnut hill, market street, west chester) * current primary care provider approval for participation * english speaking young adult exclusion criteria: * male or female age \< 19 years * no presence of a chronic condition or cognitive disability * last visit with pediatric pcp occurring prior to january 1, 2011 * not currently active in one of four identified pediatric practices (cobbs creek, chestnut hill, market street, west chester) * current pcp disapproves participation * non-english speaking caregiver inclusion criteria: * has a child enrolled in the study * child has consented/assented to allow them to participate * english speaking caregiver exclusion criteria: * child did not consent/assent to allow them to participate * non-english speaking
mdr-juggerknot mini soft anchor in maxillofacial tmj

Conditions: TMJ Disc Disorder; TMJ Pain; TMJ Sounds on Opening/Closing the Jaw; TMJ Disease

Summary: the objective of this retrospective consecutive series pmcf study is to collect data confirming safety, performance and clinical benefits of the juggerknot mini soft anchor (implant and instrumentation) when used for soft tissue to bone fixation in the treatment of temporomandibular joint (tmj) surgery. safety, performance, and clinical benefits will be evaluated at the following time points: pre op, 6 weeks, 3 months and 1-year follow-up. juggerknot mini has been on the market since november of 2011.

the primary objective is to confirm safety of the study products. this will be assessed by recording the incidence and frequency of revisions, complications, and adverse events. relationship of the events to either implant or instrumentation should be specified. the secondary objective is the assessment of performance and clinical benefits by analyzing recorded patient-reported clinical outcomes measures (proms).

Eligibility criteria:
inclusion criteria: * implanted with one or more juggerknot mini soft anchor(s) with either a 2-0 or 3-0 suture * must have undergone repair, repositioning or reattachment of soft tissues, ligament and tendons to the mandible is required for surgical stabilization of the tmj articular disc exclusion criteria: * local infection. * patient conditions including blood supply limitations and insufficient quantity or quality off bone or soft tissue. * patients with mental or neurological conditions who are unwilling or incapable of following postoperative care instructions or patients who are otherwise unwilling or incapable of doing so. * foreign body sensitivity where material sensitivity is suspected. * off-label use. * sepsis. * patient is a prisoner. * patient is a known alcohol or drug abuser.
two regimens of ivig in the treatment of newly diagnosed itp in children

Conditions: Newly Diagnosed Immune Thrombocytopenia in Children, First Line Treatment

Summary: to compare the efficacy of two different dosage regimens of intravenous immune globulin (ivig) in the treatment of children with newly diagnosed immune thrombocytopenia, and to reduce related adverse reactions and economic burdens on the premise of ensuring the remission rate


Eligibility criteria:
inclusion criteria:subjects enrolled in this study must meet all of the following criteria: 1. meet the diagnostic criteria of itp and be diagnosed for the first time without treatment 2. age \> 28 days and ≤ 14 years old 3. plt\<20×109/l 4. have signed the informed consent exclusion criteria:anyone who has any of the following conditions will not enter the clinical study: 1. intracranial hemorrhage or severe gastrointestinal or urinary tract hemorrhage requiring emergency treatment, such as simultaneous use of platelet transfusion and glucocorticoid therapy 2. received glucocorticoid or ivig therapy within 6 months 3. weight \> 40kg 4. menstrual female patients 5. patients with underlying diseases such as tumor diseases, autoimmune diseases or genetic diseases 6. patients who have received radiotherapy and chemotherapy 7. there are any significant abnormal coexisting diseases or mental illnesses that affect the patient's life safety and compliance, and affect informed consent, research participation, follow-up or interpretation of results -