Kornimate/medical-research-clean huggingface dataset:
safety and efficacy study of single-dose oral cem-101 in patients with uncomplicated urogenital gonorrhea

Conditions: Uncomplicated Urogenital Gonorrhea

Summary: to determine the safety and efficacy of a single dose of solithromycin (cem-101) for the treatment of uncomplicated urogenital gonorrhea.


Eligibility criteria:
inclusion criteria: 1. evidence of a urogenital gonococcal infection (prior culture, naat test, gram stain, sexual contact) 2. willing to abstain from anal, oral, or vaginal sexual intercourse or use condoms until study completion. 3. females of childbearing potential (including females less than 2 years post-menopausal) must have a negative pregnancy test at enrollment. exclusion criteria: 1. confirmed, or suspected, complicated or systemic gonococcal infections such as pelvic inflammatory disease, arthritis, or endocarditis. 2. known hiv, chronic hepatitis b, or hepatitis c infection. 3. known concomitant infection which would require additional systemic antibiotics. 4. use of systemic or intravaginal antibiotics within 30 days prior to study drug administration. 5. current use of corticosteroid drugs or other immunosuppressive therapy. 6. cytotoxic chemotherapy or radiation therapy within the previous 3 months. 7. known significant renal, hepatic, or hematologic impairment. 8. history of intolerance or hypersensitivity to macrolide antibiotics. 9. any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy and follow-up could be completed (e.g., life expectancy \<30 days).
effect of tranexamic acid in upper gastrointestinal bleeding

Conditions: Gastrointestinal Hemorrhage

Summary: the investigators hypothesize that addition of tranexamic acid, an antifibrinolytic agent, to conventional therapy will lead to an improved outcome characterized by lower transfusion requirements.

after informed consent is obtained patients will be randomized to receive either tranexamic acid or placebo in additional to conventional therapy. all patients with gastrointestinal hemorrhage who are admitted to the icu are managed in consultation with the gi physicians. the icu team in consultation with the gastroenterology team will manage these patients. tranexamic acid will be administered in a dose of 1 gm intravenously every 6 hours for four days. the majority of patients with gi bleeding will spontaneously stop bleeding. however, in those patients that do not and are hemodynamically unstable it poses a significant management challenge. management of these individuals includes resuscitation followed by endoscopy as well as therapy guided by clinical diagnosis. with optimal therapy mortality in these individuals remains high and the amount of blood transfusion on occasions turns out to be massive and often the outcomes are futile. tranexamic acid is an antifibrinolytic agent that has been shown to be associated with reduced bleeding and transfusion requirement in surgical patients. we would like to randomize patients to receive either tranexamic acid or placebo in addition to conventional therapy and monitor outcome. this study should provide us with information about the efficacy of this medicine in patients with upper gi bleeding. data from this trial will provide us information about utility of pursuing this modality of therapy.

Eligibility criteria:
inclusion criteria: * all patients with gi bleed if the following criteria are met: * has received 4 units of prbcs within a 24-hour period, or * has orthostatic hypotension (drop in sbp of 20mmhg or drop in dbp of 10mmhg after fluid resuscitation with at least 20ml/kg of either isotonic fluid and/or prbcs), or * if the map remains below 60mmhg after fluid resuscitation, and * written informed consent is obtained from the subject or legally authorized representative. exclusion criteria: * pregnant or lactating women * known to have gastrointestinal malignancy * on anticoagulation therapy * patients with history of thromboembolism * patients with history of myocardial infarction or ischemic cerebrovascular accident * patient with end stage renal disease * patients with dnr status * incarcerated individuals

Keywords: tranexamic acid upper gi bleeding blood transfusion gi bleeding
trial evaluating xeomin® (incobotulinumtoxina) for cervical dystonia or blepharospasm in the united states

Conditions: Cervical Dystonia; Blepharospasm

Summary: this is a prospective, observational trial evaluating the "real world" use of xeomin®(incobotulinumtoxina). physicians may enroll patients who are eligible to be treated with a botulinum toxin for cervical dystonia or blepharospasm based upon their clinical experience. the physician must have chosen to treat the patient with xeomin® (incobotulinumtoxina) prior to and independent of enrollment in this study. physicians may choose to treat their subjects with up to 2 treatment cycles (approximately 6 months/subject) of xeomin® (incobotulinumtoxina) at a dose determined by the physician based upon his/her clinical experience with botulinum toxin. according and dependent on clinical practice, the investigators expect that subjects will be seen by the investigator for an average of 3 visits (two treatment cycles).

the primary objective of this trial is to collect, evaluate, and report observational data about the clinical use of xeomin® in a "real world" setting to determine which muscles are injected, the dose used, and how doctors administer the injection. the secondary objectives of this trial are: to collect and evaluate information about the efficacy of xeomin®. to collect and evaluate information about the effect of xeomin® on work productivity and quality of life. to monitor for any serious side effects and non-serious related side effects of xeomin®

Eligibility criteria:
inclusion criteria: * subjects 18 years of age or older. * the physician must have chosen to treat the patient with xeomin® (incobotulinumtoxina) prior to and independent of enrollment in this study. * subjects who are eligible to be treated with a botulinum toxin for cervical dystonia or blepharospasm based upon the physicians' clinical experience. there are no restrictive subject entry criteria. * subjects who are able to read, speak and understand english. exclusion criteria: * subjects who are enrolled in any clinical trial (currently or within the past 3 months) in which treatments are imposed by a protocol are not eligible for this trial. * any subject for whom botulinum toxin treatment would be contraindicated; see xeomin® prescribing information for further details.

Keywords: cervical dystonia blepharospasm
tca 15% chemical peel for improvement in hand lentigines

Conditions: Photoaging; Lentigo

Summary: this study will evaluate the efficacy of the a 15% trichloroacetic acid + 3% glycolic acid peel combination for treatment of lentigines on the hands. this peel combination is sold over the counter. patients will receive 3 treatments (spaced 4 weeks).

this clinical investigation is a prospective study consisting of a screening visit, 3 treatment visits, and 1 follow-up visit. baseline and post-treatment photos will be graded and compared. a total of 20 patients will be recruited. following informed consent and screening, subjects' dorsal hands will be photographed. patients will receive 3 treatments with the 15% tca + 3% glycolic acid peel every 4-6 weeks on the dorsal hands. post-treatment, patients will be instructed to apply aquaphor to the treated area twice daily for 5 days. patients' hands will be photographed at each visit. four to six weeks after their final treatment, subjects will return for photography.

Eligibility criteria:
inclusion criteria: * age \>21 * no laser, chemical peel, neuromodulator, filler treatment to the hands in \>3 months * at least 5 lentigines on each hand exclusion criteria: * pregnancy * breastfeeding * allergy to trichloroacetic acid * allergy to glycolic acid * open wounds on treatment area (hands) * active inflammatory disease on treatment area such as atopic dermatitis, psoriasis, dermatomyositis

Keywords: photoaging chemical peel lentigines hand rejuvenation
an open-label, multicenter study of the safety and anti viral activity of brincidofovir (bcv, cmx001) for ebola virus disease

Conditions: Ebola Virus

Summary: the purpose of this study is to assess the safety and tolerability of brincidofovir (bcv) when administered as an initial 200mg dose followed by 100mg twice weekly (biw) for a total of 5 doses.


Eligibility criteria:
inclusion criteria: * positive for ebola virus rna in plasma * subject must be able to ingest, absorb, and tolerate oral medication * subject must be willing to use adequate contraception during their participation exclusion criteria: -
relationship between the clinical pharmacist & antibiotic use by using the electronic program

Conditions: Clinical Pharmacists; Electronic Medical Record

Summary: a retrospective cohort study to explore the association between clinical pharmacists' interventions and antibiotic consumption through the use of the medical electronic reports and to identify mortality and cost savings in hospital infectious disease.

the role of clinical pharmacist includes : 1. a check of suitable selection and dosing of antimicrobials according to the diagnosis, type of infection, antimicrobial cultures as possible, comorbidities of patients (renal or hepatic function, etc), adverse effect, and drug interaction with other drugs. 2. documentation of the clinical intervention, cost-saving, adverse effect,, antimicrobial culture and antimicrobial consumption on the electronic program (cpc "clinical patient care"). 3. the clinical pharmacist inspector reviews the data recorded on cpc.

Eligibility criteria:
inclusion criteria: * all inpatient with infectious disease (disorders caused by organisms as (bacteria, viruses, fungi, or parasites). exclusion criteria: * any other cause of hospital admission other than infectious disease.

Keywords: clinical pharmacist antibiotic consumption antibiotic use cost-saving
prevention of postpartum weight retention in low income wic women

Conditions: Obesity

Summary: this study will examine the effects of an online behavioral intervention to promote weight loss in low income postpartum women in the wic program.

this program is designed to reduce postpartum weight retention in low income women in the wic program. the weight loss program will be delivered over the internet and will use behavioral weight loss techniques.

Eligibility criteria:
inclusion criteria: * women * age 18-40 years. * delivery within 6-52 weeks * exceed pre-pregnancy weight by at least 4.5 kg (10 pounds) or current body mass index (bmi) \>/= 25 * current bmi \> 22 * english or spanish speaking * has internet access at home or a landline * literacy of at least 5th grade reading level * has a cell phone exclusion criteria: * pregnant or planning to become pregnant * relocating in the next year * serious psychological problems (untreated depression, schizophrenia, bipolar disorder) or medical problem (i.e. heart disease, cancer, renal disease and diabetes), for which physician supervision of diet and exercise prescription is needed.

Keywords: postpartum weight retention low income women wic online
ex vivo transformation of white adipose tissue (wat) into brown adipose tissue (bat) in morbidly obese patients using the ex vivo adipocyte expansion (exadex) approach: proof of concept. from white to brown adipose tissue

Conditions: Obesity

Summary: obesity and metabolic associated diseases such as type 2 diabetes, nash, cardiovascular diseases, are the dysregulation of energy homeostasis associated with an imbalance between different types of adipose tissues (ats). white at (wat) which stores energy and functions as a fat storage depot, is fibrotic whith chronic inflammation and is found in excess. on the other hand, brown and beige ats (bats), considered as the good ats because they regulate energy expenditure, are almost undetectable in individuals with obesity. in addition, bat and wat produce different hormones that are involved in the control of energy homeostasis via central and peripheral actions. a promising emerging therapeutic approach is to restore bat in patients with severe obesity in two ways, i) by stimulating bat in individuals with obesity by pharmacological treatment, ii) by injecting bat into individuals with obesity using a cell-based therapy approach. however, the development of these two proposals is limited both by the lack of in vitro preclinical bat models relevant for the screening and validation stages of drug candidates, and by the lack of physiologically functional bat compatible with tissue graft. the bottleneck is the absence of an unlimited source of human bat. the exadex technology makes possible in vitro to turn wat derived from lean donors into bat. this new technology offers the possibility of having in vitro predictive human 3d models suitable for the identification and characterization of compounds affecting at biology, and paves the way for the production of bat for cell-based therapy of obesity and associated metabolic diseases. the primary objective of the study is addressed the effectiveness of the exadex process to induce, ex vivo, the conversion of wat from obese patients into tab. the secondary objectives are 1) to compare the efficacy for conversion into bat when wat derived from either from visceral or from subcutaneous at; 2) to investigate the capacity of the exadex-bat to produce the fgf21 and adiponectin batokines and to respond to insulin.


Eligibility criteria:
inclusion criteria: inclusion: * karnofsky index \> 70 * imc \> 35 kg/m2 associated with a comorbidity : hypertension ; type 2 diabetes; disabling osteoarthritis; sleep apnea syndrome with device. * failure of a previous well-conducted medical treatment (multidisciplinary management of more than six months preoperatively) exclusion criteria: * psychiatric counter-indications * anaesthetic counter-indications * progressive neoplastic pathologies * chronic alcoholism * severe uncontrolled infection * renal failure (cockroft's clearance \<30ml/min) * pregnancy
radiofrequency ablation (rfa) of tumors acquired in childhood

Conditions: Neoplasms, Benign; Neoplasms, Malignant

Summary: this is a single-center, phase ii study including only patients on whom a decision to conduct radiofrequency ablation (rfa) has already been made. the primary objective of this study assess if quality of life was improved by rfa as assessed at baseline, 3 and potentially 6 and 12 months following rfa for the benign lesions. rfa is an imaging guided percutaneous or intra-operative procedure that uses a probe on the end of a sharp needle that is inserted directly into the tumor. the tumor is ablated by heating the probe (using an electrical current alternating at radio frequency) which raises the temperature of the tumor potentially causing irreversible cell death. rf ablation is an alternative for local tumor control when other treatments (surgery, radiotherapy or chemotherapy) are not feasible (less effective or at higher risk). thermal ablation at times is the only remaining alternative for patient cure, prolonged survival or palliation. cryotherapy, and microwave, laser and focused ultrasound are alternative thermal ablation techniques used in adults but there has been no experience in children with these alternative methods. to be eligible for this study, patients must have acquired lesions at \< 21 years of age (central nervous system lesions are excluded from this study). study participants will have the rfa procedure performed at seattle children's and will have follow-up evaluations at various time points post-rfa.


Eligibility criteria:
inclusion criteria: * lesion acquired in childhood (at \<21 years of age) * any lesion location except cns * any malignant tumor or metastasis * any benign lesion (e.g. desmoids, venous or lymphatic vascular anomalies, aneurysmal bone cysts, osteoid osteoma, tongue hypertrophy, or painful neuropathy) * patients with malignant disease have had histologic confirmation of disease at initial diagnosis. * ≥ 90 day life expectancy * potential benefit of rfa outweighs risk as determined by pi * other local tumor control measures are not recommended for malignant lesion based on review in multidisciplinary team conference or the patient refuses recommended local tumor control measures * the patient is not expected to become short of breath at rest after rfa (forced vital capacity ≥33% of normal by pulmonary function tests) if pulmonary rfa is considered exclusion criteria: * patients with uncontrolled infection. * patients with co-morbidities affecting inclusion criteria above. * patients who are pregnant and/or breastfeeding. * patients who had a change in chemotherapy within one month before rfa * patients who have planned change in chemotherapy and/or radiation therapy (to same site as rfa) interventions within the first three months following rfa. * patients should not be considered for pulmonary rfa if they have poorly compliant lungs (recently required mechanical ventilation) or require supplemental oxygen.
nmes for achilles tendon rupture

Conditions: Achilles Tendon Rupture

Summary: the majority of patients suffering an achilles tendon rupture develop long term functional deficits in the affected leg. the goal of the proposed study is to evaluate a new rehabilitation protocol using neuromuscular electrical stimulation (nmes) for reducing muscle atrophy and improving tendon properties. if proven beneficial, the proposed protocol can be easily adopted and incorporated as part of routine care for achilles tendon rupture.

achilles tendon ruptures (atr) are common and permanently affect the function of the lower leg. regardless of treatment approach the majority of patients develop long term functional deficits, which include decreased plantar flexion strength, lower heel-rise height, and altered gait patterns. it is believed that tendon lengthening and calf muscle atrophy, which develop during the first few weeks of recovery, are major factors contributing to these functional deficits. the initial development of atrophy is likely caused by reduced loading and muscle activity of the affected leg. however, long-term atrophy may be related to tendon elongation. on the other hand, tendon elongation initially rises during the first few weeks of unloading and slowly reduces, but not completely, when loading is resumed. however, atrophied calf muscles may not provide sufficient loading for optimal tendon recovery. therefore, there seems to be vicious spiral between tendon elongation and muscle atrophy. the objective of this study is to develop a neuromuscular electrical stimulation (nmes) rehabilitation protocol for achilles tendon ruptures. our preliminary data has shown that force applied to the tendon can be modulated using electrical intensity and pad placement. therefore, nmes can produce significant contraction in the calf muscles and induce controllable, low-magnitude, cyclic loading to the tendon; which cannot be achieved with voluntary muscle contractions. this approach can potentially overcome limitations of the current rehabilitation protocols.

Eligibility criteria:
inclusion criteria: * achilles tendon rupture exclusion criteria: 1. those unable to understand spoken english. 2. participants treated non-operatively 3. augmented surgical repair (i.e., use of additional tissue at the repair site) 4. tendon ruptures associated with the use of fluoroquinolones (examples include ciprofloxacin (cipro), gemifloxacin (factive), levofloxacin (levaquin), moxifloxacin (avelox), norfloxacin (noroxin), and ofloxacin (floxin)) 5. allergy to ultrasound gel 6. any other condition affecting the ability of the participant to walk or jump 7. any other health conditions known to impair normal healing: diabetes, cardiovascular conditions decreasing blood supply to the leg 8. those unable to consent
exploring the effectiveness of online self-help for parents of children with food allergies

Conditions: The Well Being of Parents of Children With Food Allergies

Summary: this study aims to conduct an initial evaluation of whether online self-help can improve the quality of life of parents of children with food allergies.

this study is a pilot randomised controlled trial (rct) comparing online self-help for parents of children with food allergies with a wait-list control. a battery of self-report measures will be administered online at baseline (week 0), post-intervention (week 4) and at follow-up (week 8).

Eligibility criteria:
inclusion criteria: * being a parent of at least one child (under the age of 18) who has a food allergy. * adequate understanding of written english. exclusion criteria: * having consulted on the design of the self-help website.
bioequivalence study of ropinirole hydrochloride er tablets 2 mg under fed condition

Conditions: Healthy

Summary: this is an open label, randomised, balanced, two-treatment, two-period, two-sequence, crossover, oral bioequivalence study.

the objective of this study was to determine the single-dose oral bioequivalence of ropinirole hydrochloride extended release tablets 2 mg of dr. reddy's laboratories limited, india with requip® xl (ropinirole hydrochloride extended release) 2 mg tablets of glaxosmithkline, usa, in normal, healthy, adult, human subjects under fed condition.

Eligibility criteria:
inclusion criteria: 1. healthy human subjects aged between 18 and 45 years (including both). 2. subjects with a bmi between 18.5 - 24.9 kg/m2 (including both) but body weight not less than 45 kgs. 3. subjects with normal health as determined by personal medical history, clinical examination, and laboratory examinations including serological tests. 4. subjects having normal 12-lead electrocardiogram (ecg). 5. subjects having normal chest x-ray (pia view). 6. subjects able to communicate effectively. 7. subjects willing to give written informed consent and adhere to all the requirements of this protocol. 8. female subjects who are postmenopausal or surgically sterile. 9. female subjects practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm,intrauterine device (iud) or abstinence. exclusion criteria: 1. subjects having contraindications or hypersensitivity to ropinirole or domperidone or related group of drugs. 2. history or presence of any medical condition or disease according to the opinion of the physician. 3. history or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder. 4. history or presence of significant alcoholism or drug abuse in the past one year. 5. history or presence of significant smoking (more than 10 cigarettes or bidis/day or consumption of tobacco products). 6. difficulty with donating blood. 7. difficulty in swallowing solids like tablets or capsules. 8. systolic blood pressure less than 110mm hg or more than 140 mm hg. 9. diastolic blood pressure less than 70 mm hg or more than 90 mm hg. 10. pulse rate less than 50 beats/minute or more than 100 beats/minute. 11. use of any prescribed medication during last two weeks or otc medicinal products during the last one week preceding the first dosing. 12. major illness during 3 months before screening. 13. participation in a drug research study within past 3 months. 14. donation of blood in the past 3 months before screening. 15. female subjects demonstrating a positive pregnancy screen. 16. female subjects who are currently breast-feeding. 17. female subjects with child bearing potential using prohibited contraceptive method (oral, injectable or implantable hormonal agents).

Keywords: bioequivalence ropinirole hydrochloride crossover