Kornimate/medical-research-clean huggingface dataset:
phase 3 efficacy and safety study of cd07805/47 topical gel in subjects with facial erythema associated with rosacea

Conditions: Rosacea

Summary: this is a phase 3 efficacy and safety study of cd07805/47 topical gel in subjects with facial erythema associated with rosacea. the study hypothesis is that cd07805/47 gel, applied topically once daily is more efficacious than vehicle and provides an acceptable safety profile in the treatment of facial erythema associated with rosacea.


Eligibility criteria:
key inclusion criteria: 1. male or female who is at least 18 years of age or older. 2. a clinical diagnosis of facial rosacea. 3. a clinician erythema assessment (cea) score of greater than or equal to 3 at screening and at baseline/day 1 (prior to the study drug application). 4. a patient self assessment (psa) score of greater than or equal to 3 at screening and at baseline/day 1 (prior to the study drug application). key exclusion criteria: 1. particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia. 2. presence of three (3) or more facial inflammatory lesions of rosacea. 3. current treatment with monoamine oxidase (mao) inhibitors, barbiturates, opiates, sedatives, systemic anesthetics, or alpha agonists. 4. less than 3 months stable dose treatment with tricyclic antidepressants, cardiac glycosides, beta blockers or other antihypertensive agents. 5. current diagnosis of raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, sjögren's syndrome, or depression.

Keywords: rosacea
crems prostate biopsy pain relief study

Conditions: Pain

Summary: the current standard for pain relief during prostate biopsy is the injection of local anesthetic agents into or around the prostate at various sites including apex, base, lateral aspects and into the prostate itself. despite such anesthetic injection, some men still experience severe pain and often at the base of the penis. the study audits current practices comparing the degree of pain relief provided by injection at basal versus basal+apical sites. all these injection sites are standard practice at our hospital.


Eligibility criteria:
inclusion criteria: * men who come for prostate biopsy exclusion criteria: * men who are unwilling or unable to consent and fill in the forms

Keywords: prostate biopsy pain
racial and genetic biomarkers of response in tissue samples from patients with endometrial cancer

Conditions: Stage I Uterine Corpus Cancer; Stage II Uterine Corpus Cancer; Stage III Uterine Corpus Cancer; Stage IV Uterine Corpus Cancer

Summary: this research study is studying racial and genetic biomarkers of response in tissue samples from patients with endometrial cancer. studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. dna analysis of tumor tissue may also help doctors predict how well patients will respond to treatment.

primary objectives: i. to identify racial categorization as the proportion of genetic background of african-american or european-american women with endometrioid endometrial cancer (eec). ii. to evaluate the association of racial genetic admixture with clinicopathologic variables and outcomes. secondary objectives: i. to compare the concordance between racial genetic admixture and self-designated race categorization. outline: this is a multicenter study. patients are stratified by race (african-american vs european-american) and disease stage (i vs ii vs iii vs iv). dna from archived frozen normal tissue samples is genotyped for the ancestry informative markers. clinicopathological and demographic characteristics associated with each sample are also collected.

Eligibility criteria:
inclusion criteria: * histologically confirmed endometrial cancer * stage i-iv disease regardless of grade * underwent surgical staging including hysterectomy, bilateral oophorectomy, washings, and pelvic lymphadenectomy * eligible and evaluated on gog-0210 clinical trial, a molecular staging study in endometrial cancer * available frozen or formalin-fixed and paraffin-embedded normal tissue that is free of tumor cells and yields sufficient high-quality normal dna for testing * consented their specimens and clinical data to be collected and used in future studies * self-declared african-american or caucasian race
care coordination and proactive care to improve utilization of resources and reduce expenditure in high risk inflammatory bowel disease (ibd) patients

Conditions: Inflammatory Bowel Diseases

Summary: the study team performed a randomized controlled trial to evaluate the efficacy of a care coordination intervention composed of proactive symptom monitoring and algorithm-based triggers to improve patient reported outcomes (pros) and healthcare expenditures for high-risk patients with ibd. enrolled patients with ibd were randomized to proactive symptom monitoring with the support of a care coordinator or usual care.


Eligibility criteria:
inclusion criteria: * established diagnosis of ibd (with at least 3 office visits) * followed in gi clinic within 1 year of enrollment * in top 20th percentile of predicted risk for subsequent healthcare utilization (previously validated model) exclusion criteria: * non-ibd driver for high utilization (e.g., active cancer undergoing treatment * a life expectancy of less than one year, were excluded from participation.
a study of alrt1057 in patients with aids-related kaposi's sarcoma

Conditions: Sarcoma, Kaposi; HIV Infections

Summary: the purpose of this study is to see if alrt1057 is safe and effective in treating patients with aids-related kaposi's sarcoma (ks).

patients receive open-label alrt1057 for 16 weeks, as tolerated. in the absence of unacceptable toxicity, patients may continue treatment indefinitely provided they continue to benefit from therapy and the study remains open and active. thirteen patients are treated initially. if at least one response is observed in these patients, up to 14 additional patients will be evaluated.

Eligibility criteria:
inclusion criteria patients must have: * hiv positive status and histologic confirmation of ks. * cd4 count \> 200 mm3 (required of one-half of patients). * minimum of 6 mucocutaneous ks lesions, including at least 3 raised lesions meeting criteria for "indicator" lesions. * acceptable organ system function. exclusion criteria co-existing condition: patients with the following conditions or symptoms are excluded: serious or intercurrent illness or infection that would interfere with the ability of the patient to carry out the treatment program. prior medication: excluded: * systemic therapy for ks within 30 days. * local or topical therapy for ks indicative lesions within 60 days. * systemic therapy with vitamin a in doses exceeding 15,000 iu per day or other retinoid class drug. required: approved antiretroviral therapy.

Keywords: aids-related opportunistic infections sarcoma, kaposi antineoplastic agents
efficacy and safety of bms-298585 alone or in combination with pravastatin in subjects with mixed dyslipidemia

Conditions: Dyslipidemia

Summary: this is a randomized, double-blind, dose-ranging, placebo-controlled trial to determine the lipid-lowering efficacy and safety of bms-298585 (muraglitazar) alone in combination with pravastatin in subjects with mixed dyslipidemia.


Eligibility criteria:
inclusion criteria: * non-diabetics * serum tg \>150 mg/dl and \< or = 600 mg/dl * serum ldl-c \>130 mg/dl exclusion criteria: * type 1 or type 2 diabetics * fasting plasma glucose \>126 mg/dl * treatment with lipid-lowering drugs, unless they can be withdrawn within the following time frame prior to the first qualifying lipid determination (week 2): * niacin or bile-acid binding agents and hmg coa reductase inhibitors: 8 weeks * fibrates: 8 weeks * probucol: 1 year * history of active liver disease and/or history of thiazolidinedione-related (troglitazone, rosiglitazone, or pioglitazone) liver abnormalities, hepatic dysfunction, or jaundice

Keywords: mixed dyslipidemia
sensory integration (processing) disorder among children with behavioral insomnia and children with feeding disorder

Conditions: SID; Feeding Disorder; SPD

Summary: behavioral insomnia of childhood is a prevalent condition, affecting 10-30% of children 6-36 months of age. if left untreated, bedtime problems and night wakings can negatively impact the daytime functioning and behavior of the child, as well as the entire family. feeding difficulties are common in pediatric practice and encompass a spectrum ranging from children with physiological difficulties in ingesting food, through picky eaters to full fledged infantile feeding disorders. we have recently shown that feeding and eating difficulties are more prevalent among children with behavioral insomnia of childhood and that sleep problems are more frequent in children with feeding disorders. we hypotesize that spd is a common etiology for both sleep and feeding disorders and that children with sleep or feeding disorder have increased rate of sensory intergration disorder (sid) compared with healthy controls.


Eligibility criteria:
inclusion criteria: * children 7-36 months of age with behavioral insomnia of childhood based on the international classification of sleep disorders (icsd) criteria . * children 7-36 months of age with feeding disorders based on chatoor criteria. * children 7-36 months of age who attend well-care clinics in the metropolitan of tel aviv for routine periodic medical examination. exclusion criteria: children with * chronic medical conditions. * congenital abnormalities. * significant developmental delay.
increasing physical activity in persons with depression

Conditions: Depression; Physical Activity

Summary: pilot study to assess a multi-component intervention to increase physical activity in persons with depression.

the research project is a pilot study to assess the effects of a multi-component intervention in increasing physical activity among persons with depression. individuals meeting inclusion/exclusion criteria will be enrolled in the 12-week intervention. intervention components will include self-monitoring, active living counseling, and facility access. blood samples will be collected at baseline. assessments (anxiety, stress, sleep) and sample collection will also occur at 2 time points during the intervention (weeks 7 and 13). changes in physical activity will be assessed using fitbits to measure weekly minutes of moderate/vigorous activity.

Eligibility criteria:
inclusion criteria: * age 18-65 years * positive depression screen (patient health questionnaire \[phq-9\]) or current antidepressant treatment * report \<150 minutes of weekly moderate-to-vigorous physical activity (mvpa) on the exercise vital sign (evs) * written and verbal fluency in english exclusion criteria: * medical condition contraindicating physical activity participation * cognitively unable to give informed consent * non-english speaking
breast cancer in young women: is it different?

Conditions: Female Breast Cancer

Summary: breast cancer is the leading cancer among women in saudi arabia representing almost the third of cancer diagnosed in saudi women. breast cancer in saudi women is more frequently observed at young age. the data on this observation is either lacking or scares. furthermore, the pathological and molecular features of breast cancer in young women are not clear. the study will provide important information to the national health care planner about this disease in young women including shedding light on possible genetic risk factors

the study is a prospective longitudinal cohort study of young women with breast cancer. over a 3-year period, we aim to identify a total of 600 women with newly diagnosed breast cancer, of those 300 women age 40 and younger and 300 older women from academic and community health care institutions across the riyadh area. it is anticipated at least 400 of these women will agree to participate in the study. the comparable control group of older patients with breast cancer will be used for study comparison. patient surveys, medical record review, and blood and tissue collection will be utilized. women will be surveyed every 6 months after diagnosis. the study will investigate short and long-term disease and treatment issues, and psychosocial concerns. we will also collect tumor and blood samples to characterize the pathological and molecular aspects of tumors, and establish tumor bank for future studies.

Eligibility criteria:
inclusion criteria: * female * diagnosis of breast cancer * age 40 or younger at diagnosis for study group and older women for control group * informed consent obtained from patient exclusion criteria: * absence of informed consent

Keywords: breast cancer
evaluation of clear aligner trays to straighten teeth

Conditions: Malocclusion

Summary: the objective of this study is to evaluate the efficacy of clear aligners to correct tooth malocclusions with the use of attachments and/or buttons, as determined by the amount of teeth movement and overall achievement goals of the treatment plan.

this is a prospective, multi-center study with a maximum duration of 24 months or longer depending on refinements, to assess the safety and efficacy of 3m clear aligners, with the use of attachments to correct teeth malocclusions. the subject population for this study will be male and female subjects ≥ 14 years of age. subjects who meet the inclusion and exclusion criteria will be asked to participate in the study. up to a total of 180 subjects may be enrolled at up to 12 different clinical research sites, (up to 15 subjects per site). the subjects will undergo a target of up to 24 months (or longer depending on refinements) of treatment to align the teeth to the planned target. subjects will wear the clear aligners for at least 22 hours per day, with the exception of consumption of meals and beverages, with the exception of water, which can be consumed while wearing the aligners. during each 6-week period between follow up visits, subjects will wear each set of clear aligners for 2 weeks, in the order indicated per the orthodontists treatment plan.

Eligibility criteria:
inclusion criteria: 1. subject is at least 14 years of age. 2. subject is willing and able to give informed consent. 3. subject is willing to be digitally scanned at each 6-week visit, including after application of attachments. 4. subject has a need for single or double arch orthodontic treatment with a target duration of 18 months or less. 5. subject has good oral hygiene defined by the orthodontist. 6. subject has only permanent dentition. exclusion criteria: 1. subject has skeletal discrepancies requiring surgery 2. subject is undergoing active dental work 3. subject has severe open bite \> 2 mm 4. subject has severe overjet \> 4 mm 5. subject has deep bite \> 3 mm 6. subject has over crowding per arch \> 4 mm 7. subject has dental prostheses/implants that will interfere with projected teeth movement 8. subject is taking systemic steroid medication 9. subject is taking biphosphonates or any other medication for treatment of osteoporosis

Keywords: aligners
comparative effects of rebound training and theraband resistance exercise in badminton players

Conditions: Sports Physical Therapy

Summary: comparative effects of rebound training and theraband resistance exercise in badminton players with patellofemoral pain syndrome

comparative effects of rebound training and theraband resistance exercise on agility, power and dynamic balance in badminton players with patellofemoral pain syndrome

Eligibility criteria:
inclusion criteria: * females * age 18 to 25 years * positive patellofemoral compression test ( pain is in around the patella and back of knee cap) with playing experience of 3 years will be included * minimum sports activity 1 hour 4 times a week exclusion criteria: * recreational players * players with recent injury in past 6 months * any musculoskeletal and neurological problem * player addicted to any drug or alcohol will be excluded

Keywords: agility dynamic balance power patellofemoral pain
cdi synbiotic study

Conditions: Clostridium Difficile Infection

Summary: the investigators hypothesize that treatment with a synbiotic mixture consisting of inulin lactobacillus rhamnosus (lgg®), lactobacillus acidophilus (la-5®), lactobacillus paracasei (l. casei 431®) and bifidobacterium lactis (bb-12®) can reduce the number of c. difficile recurrences significantly.

probiotics have been tested for their efficacy in preventing infection with c. difficile after antibiotic exposure. some of the most effective probiotics tested lactobacillus rhamnosus (lgg®), lactobacillus acidophilus (la-5®), lactobacillus paracasei (l. casei 431®) and bifidobacterium lactis (bb-12®). however, most studies have focused on prevention of the first incidence of c. difficile infection rather than prevention of re-infection with c. difficile. recurrence rates of c. difficile infection (cdi) among hospitalized patients are 15-25% - either as relapses caused by the original organism or re-infection following treatment. the potential of probiotics in preventing re-infection is less studied in these patients. further, prebiotics which are carbohydrates only metabolized by beneficial bacteria have gained much attention the recent years for their health benefits through stimulating growth of specific types of bacteria in the gut, and recent data from mouse studies show that the prebiotic inulin can eliminate c. difficile growth, but the use of prebiotics in relation to c. difficile elimination has yet to be proven in humans. the investigators hypothesize that treatment with a synbiotic mixture consisting of inulin lactobacillus rhamnosus (lgg®), lactobacillus acidophilus (la-5®), lactobacillus paracasei (l. casei 431®) and bifidobacterium lactis (bb-12®) can reduce the number of c. difficile recurrences significantly.

Eligibility criteria:
inclusion criteria: * patients diagnosed with primary cdi * treatment with vancomycin * subjects over 18 years of age * signed informed consent exclusion criteria: 1. chemotherapy within two months and an absolute neutrophil count of \< 1000 neutrophiles/mm3 2. acute leukemia 3. serious immunodeficiency 4. pancreatitis 5. planned or recent intraabdominal operation within a time window of 14 days 6. terminal disease with expected survival time \< 3 month 7. probiotic consumption within two weeks prior enrollment 8. pregnant or lactating women 9. a history of inflammatory or irritable bowel disease 10. colectomy and cirrhosis 11. septicemia 12. toxic megacolon

Keywords: probiotics prebiotics synbiotics
genetic of aortic valve stenosis - clinical and therapeutic implications

Conditions: Aortic Valve Stenosis

Summary: pathophysiology of aortic valve stenosis remains poorly known. the aim of the present study is to identify genetic factors involved in this disease using a case control trial design.

aortic valve stenosis (as) is the most common valvular disease and the second most common indication for cardiac surgery in western countries. as has long been considered as a passive and degenerative process. recent data challenged this concept, showing that as is an active and highly regulated process with some similarities to atherosclerosis. however, pathophysiology of as remains poorly understood and preliminary data suggest that genetic factors may be involved. the aim of the present study is to identify genetic factors involved in this disease using a case control trial design (1000 patients with as and 1500 controls with no evidence of valve disease). for all patients and controls, blood samples including dna and echocardiography will be performed.

Eligibility criteria:
patients: inclusion criteria : * age \>=18 years * pure isolated degenerative aortic valve stenosis exclusion criteria : * rheumatic, congenital or post-radiation aortic stenosis * severe renal insufficiency (clearance \< 30 ml/min) * aortic insufficiency \> or = grade 2/4 * other valve disease \> or = grade 2/4 controls inclusion criteria : - age \>=18 years exclusion criteria : * known first degree relative with aortic valve stenosis * severe renal insufficiency (clearance \< 30 ml/min) * any valve disease \> or = grade 2/4

Keywords: aortic valve stenosis genetic mineralisation inhibitors
the impact of beef on muscle fatigue in older adults

Conditions: Muscle Weakness; Muscle; Fatigue, Heart; Older Adults

Summary: the goal of this controlled-feeding cross-over diet intervention is to compare a beef diet to a vegetarian diet on muscle fatigue in older adults. the aims are: aim 1: to test the hypothesis that muscle fatigue is attenuated in older adults consuming beef compared to older adults consuming a plant-based diet. aim2: to test the hypothesis that daily beef consumption improves biochemical indicators related to muscle fatigue. participants will be randomized to consume either a beef-based diet or vegetarian diet under controlled-feeding conditions for 8 weeks. after a 2-week washout period, participants will cross-over to consume either the beef diet or vegetarian diet for 8 weeks. body composition and functional muscle outcomes will be measured during each 8-week feeding period. blood samples will also be collected.


Eligibility criteria:
inclusion criteria * ages 60-85 years * ability to eat study diet meals for a total of 16 weeks * ability to perform sit-to-stand chair and 6-minute walking tests based on results from par-q questionnaire * ability to provide fasted blood samples * access to transportation * willing to abstain from alcohol consumption and/or use illicit drug use for each 8-week intervention period * ability to consent to participating in this study * english-speaking * body mass index between 18.5 (normal) and 39.9 (obese) kg/m2 * minimum total body weight of 110 pounds * non-anemia hemoglobin values: females - \>12.0 grams/dl; men - \>13.0 grams/dl * able to ambulate without assistance * physician's clearance for study participation (required prior to baseline testing) exclusion criteria * inability or refusal to sign the informed consent * significant orthopedic limitations or other contraindications to exercise * inability or refusal to perform muscle fatigue tests * has dietary restrictions that prevent to consumption of beef, soy and/or wheat * has liver or kidney complications * live or work \>25 miles from bloomington study site or does not have transportation to the study site * anticipate elective surgery during the study period * diagnosis of progressive neurological disorders, musculoskeletal disorders, osteoarthritis, rheumatoid arthritis * fracture or serious injury in the last 6 months * stroke, revascularization, deep vein thrombosis, or pulmonary embolism in the past 12 months * severe cardiovascular disease, uncontrolled systemic hypertension, chronic pulmonary disease * plan to move residence or travel out of the local area during the study period * current use of anti-coagulants (e.g. coumadin or warfarin) * current use of prescription medications that affect heart rate or blood vessel dilation * psychological or social characteristics that would interfere with their ability to fully participate in the study

Keywords: body composition older adults diet vegetarian meat beef controlled feeding intervention