Kornimate/medical-research-clean huggingface dataset:
a study (study 2) to evaluate the safety and efficacy of fmx103 1.5% topical minocycline foam in the treatment of facial papulopustular rosacea

Conditions: Facial Papulopustular Rosacea

Summary: the primary objectives of this study are to determine the efficacy and safety of fmx103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea.

this is a randomized, multicenter, double-blind, vehicle-controlled, 2 arm study to evaluate the safety and efficacy of fmx103 topical foam containing 1.5% minocycline compared to vehicle, in the treatment of participants with moderate-to-severe facial papulopustular rosacea. qualified participants will be randomized in a 2:1 ratio (active:vehicle) to receive 1 of the following 2 treatments: * fmx103 minocycline foam 1.5% * vehicle foam participants will be assigned to 1 of 2 treatments according to the randomization schedule. participants will apply (or have applied) the study drug topically once daily for 12 weeks as directed. participants will be advised to use the study drug at approximately the same time each day. both the investigator and participant will be blinded to the study drug identity. participants will return for visits at weeks 1, 4, 6, 8, 10, and 12. efficacy evaluations (inflammatory lesion counts and investigator's global assessment \[iga\] score) will be performed at weeks 4, 8, and 12 during the study. note: originally the two studies fx2016-11 and fx2016-12 were combinedly presented in the protocol registration form under one nct number (nct03142451), and later separated since results were analyzed separately.

Eligibility criteria:
inclusion criteria: 1. moderate-to-severe rosacea (as per the iga score) on the proposed facial treatment area consisting of: 1. at least 15 and not more than 75 facial papules and pustules, excluding lesions involving the eyes and scalp; 2. no more than 2 nodules on the face. 2. presence of or history of erythema and/or flushing on the face. exclusion criteria: 1. presence of any skin condition and/or excessive facial hair, on the face that would interfere with the diagnosis or assessment of rosacea. 2. moderate or severe rhinophyma, dense telangiectasia (score 3, severe), or plaque-like facial edema. 3. history of hypersensitivity or allergy to minocycline, any other tetracycline, or of any other component of the formulation. 4. active ocular rosacea (eg, conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.

Keywords: topical minocycline foam 2-arm study inflammatory lesion counts investigator's global assessment score
exploring the effectiveness of led phototherapy on common symptoms among elderly in long-term care institutions

Conditions: Low Level Light Therapy

Summary: the world is facing rapid population aging, the health needs of the elderly are complex, and their physical capabilities are degraded, and increased the possibility of having one or more chronic conditions. in 1900 to 2000, there were 7,600 million people in the united states, aged 65 and above age increased to 4.1% up to 12.6%, by 2050 is expected to increase 20.3%.in taiwan, the elderly population have 83.5% is health and sub-health, in order to allow them to perform activities of daily living independently, in particular, need to pay attention to the diverse needs of the elderly, assist the elderly to increase self-care skills, reduce disability is a very important issue.

from literature review of led phototherapy can effectively improve symptoms in the elderly, such as hair loss, dermatitis, rotator tendonitis, epicondylitis of the tibia, wound healing, back pain, patellofemoral pain, spinal neuropathy, chronic pain relief, insomnia and depression. comprehensive phototherapy and traditional chinese medicine(tcm) perspective, led phototherapy is the use of physical light energy stimulation and temperature to improve the body's microcirculation and meridian dredge, enhance the body's energy of the health and sub-health elderly, increasing physical activity perform daily functions. taiwanese elderly to take self-care by the dilemmas of the many aspects. there are 21.52% physical health problems, affecting work or daily activities are limited; there are 35.12% physical or emotional health problems affecting social activities; there are 13.01% incapable perform activities of daily living. the aim of this study was to explore the effectiveness of led phototherapy on physiological symptoms among elderly in long-term care institutions in taiwan. to examine the effects of physiological symptoms, such as mental state, muscle bone system, metabolism, autonomic balance and other meridian energy tests, it is expected to improve the body energy of healthy and sub-healthy elderly to increasing physical activity perform daily functions.

Eligibility criteria:
inclusion criteria: * consciousness clear；must be able to talk exclusion criteria: * clinical diagnosis of dementia；seasonal mood disorder

Keywords: elderly led phototherapy meridian energy sleep quality fatigue cold limbs long-term care institution
rituximab plus fludarabine in treating patients with waldenstrom's macroglobulinemia

Conditions: Lymphoma

Summary: rationale: monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. drugs used in chemotherapy use different way to stop cancer cells from dividing so they stop growing or die. combining monoclonal antibody therapy with chemotherapy may kill more cancer cells. purpose: phase ii trial to study the effectiveness of rituximab plus fludarabine in treating patients who have waldenstrom's macroglobulinemia.

objectives: * determine the objective response and time to treatment failure in patients with waldenstrom's macroglobulinemia treated with rituximab and fludarabine. * determine the toxicity of this regimen in these patients. * determine if molecular remissions are achievable in patients attaining a clinical complete response when treated with this regimen. outline: this is a multicenter study. patients receive rituximab iv over 3-6 hours once weekly on weeks 1-4, 17, 18, 30, and 31 and fludarabine iv over 10-30 minutes once daily for 5 days on weeks 5, 9, 13, 19, 23, and 27. patients are followed at least every 2 months for 2 years. projected accrual: a total of 40 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of waldenstrom's macroglobulinemia * cd20 positive by bone marrow immunohistochemistry or flow cytometry * presence of monoclonal paraprotein * igm level at least 2 times upper limit of normal (uln) patient characteristics: age: * over 18 performance status: * ecog 0-2 life expectancy: * at least 6 months hematopoietic: * absolute neutrophil count greater than 1,000/mm\^3 * platelet count greater than 25,000/mm\^3 hepatic: * bilirubin less than 2.5 times uln * sgot less than 2.5 times uln renal: * creatinine less than 2.5 mg/dl other: * not pregnant or nursing * fertile patients must use effective contraception during and for 6 months after study * no serious comorbid disease * no uncontrolled bacterial, fungal, or viral infection * no other active malignancy prior concurrent therapy: biologic therapy: * no prior rituximab * no prior nucleoside analogue therapy chemotherapy: * at least 30 days since prior chemotherapy endocrine therapy: * at least 30 days since prior steroid therapy * no concurrent corticosteroids radiotherapy: * at least 30 days since prior radiotherapy surgery: * not specified other: * no more than 2 prior courses of therapy

Keywords: waldenström macroglobulinemia
study to investigate the effect of inhaled tiotropium bromide on neurokinin-a induced bronchoconstriction in patients with mild-to-moderate asthma

Conditions: Asthma

Summary: this trial compares the outcome of treatment of mild to moderate asthma: inhaled tiotropium bromide versus placebo.


Eligibility criteria:
inclusion criteria: * informed consent * male or female, at least 18 years old * documented medical history of asthma (diagnosis at least 6 months ago) * non-smoker or at least stopped for 1 year (in case smoked earlier: maximum of 10 pack-years) * able to conduct a technically acceptable spirometry, methacholine and neurokinin-a provocation test. * at visit 1: pc20 methacholine ≤ 8 mg/ml and ≤ 3.3x10-7 mol/ml for the neurokinin-a provocation test. * at visit 1: forced expiratory value in one second \>= 80% of the predicted value. * female subjects may not get pregnant and should be using adequate contraception. exclusion criteria: * airway infection within 6 weeks prior to first study visit. * other respiratory diseases (eg copd, lung cancer, etc.) * participating in another clinical trial. * clinically relevant systemic diseases, other than asthma. * clinically significant laboratory deviations. * alcohol or drug abuse. * female subjects who are lactating.

Keywords: mild to moderate asthma
hair loss prevention study for pancreatic cancer

Conditions: Alopecia

Summary: pilot study intended for hair loss prevention in patients with pancreatic cancer who are receiving treatment containing nab-paclitaxel, gemcitabine and cisplatin.

patients with pancreatic cancer who are receiving treatment containing nab-paclitaxel, gemcitabine and cisplatin will experience hair preservation with the use of the paxman scalp cooling device, at the end of three, 3 week cycles of chemotherapy.

Eligibility criteria:
inclusion criteria: * willing and able to provide written informed consent/assent for the trial * \>18 years of age on day of signing informed consent * diagnosis of pancreatic cancer and scheduled to receive treatment with a regimen containing nab-paclitaxel, gemcitabine and cisplatin exclusion criteria: * grade 1 alopecia * existing history of scalp metastases or the presence of scalp metastases is suspected * no history of previous cancers within the past 5 years * cns malignancies (either primary or metastatic) * cold sensitivity, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, cold migraine, cold urticaria, post-traumatic cold dystrophy * imminent bone marrow ablation chemotherapy * imminent skull radiation * previously received or scheduled to undergo skull irradiation * severe liver or renal disease from any etiology as patient may not be able to metabolize or clear the metabolites of the chemotherapeutic agent * skin cancers including melanoma, squamous cell carcinoma and merkel cell carcinoma * small cell carcinoma of the lung * solid tumors that have a high likelihood for metastasis in transit * squamous cell carcinoma of the lung
nbi-98854 for the treatment of tardive dyskinesia in subjects with schizophrenia or schizoaffective disorder

Conditions: Tardive Dyskinesia

Summary: the purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses (12.5 and 50 mg) of nbi-98854 administered once daily (q.d.) for the treatment of tardive dyskinesia in subjects with schizophrenia or schizoaffective disorder.


Eligibility criteria:
inclusion criteria: * have a clinical diagnosis of schizophrenia or schizoaffective disorder and a clinical diagnosis of neuroleptic-induced tardive dyskinesia as defined in the diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv), 333.82 (see appendix 17.1) for at least 3 months prior to screening. * be receiving a stable dose of antipsychotic medication for a minimum of 30 days before study start. subjects who are not using antipsychotic medication must have stable psychiatric status. * have the doses of concurrent medications and the conditions being treated be stable for a minimum of 30 days before study start and be expected to remain stable during the study. * subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal birth control during the study. * female subjects must not be pregnant. * be in good general health and expected to complete the clinical study as designed. * have a body mass index (bmi) of 18 to 38 kg/m2 (both inclusive). * have adequate hearing, vision, and language skills to perform the procedures specified in the protocol. * have a negative urine drug screen (negative for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids) at screening and study start, except for any subject receiving a stable dose of benzodiazepine. * have a negative alcohol breath test at screening and study start. exclusion criteria: * have an active clinically significant unstable medical condition within 1 month (30 days) prior to screening. * have a history of substance dependence or substance (drug) or alcohol abuse within the 3 months before study start(nicotine and caffeine dependence are not exclusionary). * have a known history of neuroleptic malignant syndrome. * have a significant risk of suicidal or violent behavior. * receiving any excluded concomitant medication such as reserpine, metoclopramide, stimulants, or tetrabenazine * receiving medication for the treatment of tardive dyskinesia. * have a positive human immunodeficiency virus antibody, (hiv-ab), hepatitis b surface antigen (hbsag), or hepatitis c virus (hcv) antibody result at screening or have a history of positive result. * have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than nbi-98854) during the study. * have an allergy, hypersensitivity, or intolerance to tetrabenazine. * have had previous exposure with nbi-98854.
effect of carnosine on diabetes and cardiovascular risk factors

Conditions: Metabolic Diseases, Type 2 Diabetes, Cardiovascular Disease

Summary: carnosine is a naturally occurring compound with a potential health benefits. in animal studies, carnosine supplementation reduces manifestation of chronic civilization diseases, regulates subclinical inflammation, protein glycation and lipid \& glucose metabolism. our preliminary data showed the relationship between insulin resistance and carnosine content in human skeletal muscle. based on these unique results we plan to perform intervention study aimed at identifying effects of carnosine on insulin sensitivity and secretion, which might reduce the development of t2d in obese. similar metabolic effects of vitamin d3 were associated with expression of specific mirnas. circulating mirnas related to carnosine action are unknown. the putative positive effects of carnosine on insulin sensitivity and secretion in obese patients might have a tremendous impact in prevention of type 2 diabetes. identification of mirnas associated with carnosine action could provide predictors of successful therapy.


Eligibility criteria:
inclusion criteria: * bmi (28-38 kg.m-2); * waist circumference \>94 cm; * % body fat 30% * fasting glycemia \< 7 mmol/l exclusion criteria: * age \ 50 years, * change in body weight \> 5 kg in last 12 months, * obesity with bmi \> 38kg.m-2, * previously or newly (ogtt) diagnosed type 2 diabetes, * allergy, smoking, alcohol abuse, any pharmacotherapy including regular vitamin intake; * cardiovascular, hematologic, respiratory, gastrointestinal, endocrine or oncologic diseases, * kidney disease, acute inflammatory disease.
screening nasopharyngeal carcinoma with ebv associated biomarkers in zhongshan city

Conditions: Nasopharyngeal Carcinoma

Summary: all participants will be tested for ebv associated biomarkers, including ebna1-iga, vca-iga, bnlf2b total antibodies (p85-ab) et al. for all male participants and p85-ab positive female participants, ebv dna in plasma will be tested. screening positive participants will be followed up annually. all subjects will also be followed by record linkage to cancer register and population register.

sample selection - select communities of 20,000 to 40,000 populations in zhongshan city and wuzhou city as the investigators' fields. participants recruitment * subjects voluntarily attend this screening study informed consent - informed consent forms will be collected at the recruitment. questionnaires. * face-to-face interviews are conducted by well-trained investigators. tests and follow up * at initial screening, all participants will be tested for ebv associated biomarkers, including ebna1-iga, vca-iga, p85-ab et al. and in males, ebv-dna will be tested. based on ebna1-iga, vca-iga, participants will be stratified into high, moderate and low risk. screening positive include p85-ab positive, high or moderate risk of npc or ebv dna positive. the rest will be screening negative. * during the initial screening and following up, people with high risk or p85-ab positive will refer to the diagnostic workup for npc. briefly, fiberoptic endoscopy and pathological biopsy will be performed by otorhinolaryngologists. * screening positive people not diagnosed as nasopharyngeal carcinoma in the first year will be followed up annually. * ebv dna single positive people will refer to the diagnostic workup for npc in the third year of follow up. * the rest of the blood samples will be stored at the biobank of zhongshan people's hospital for further research. * all subjects will also be followed by record linkage to cancer register and population register.

Eligibility criteria:
inclusion criteria: * subject residents in zhongshan city or wuzhou city * subject has no medical record of nasopharyngeal carcinoma * ecog 0-2 * subject is able to comprehend, sign, and date the written informed consent document to participate in the study. * subject has psychical condition and well consciousness, and also accept and cooperate with the follow-up of this study. exclusion criteria: * subject has heavy cardiovascular, liver or kidney disease. * subject has contraindications to nasopharyngeal fiberoptic endoscopy.

Keywords: screening nasopharyngeal carcinoma biomarker
bilateral transversus abdominis plane block and postoperative pain intensity after elective cesarean delivery

Conditions: Postoperative Pain

Summary: the patients planned to go under elective cesarean delivery under general anesthesia are randomly assigned to have either bilateral transversus abdominis plane (tap) block or usual standard analgesics after cesarean. pain score (verbal analog scale vas) and analgesic requirements are recorded. it's supposed that both are significantly reduced in patients undergoing tap block.


Eligibility criteria:
inclusion criteria: 1. elective cesarean delivery 2. term pregnancies 3. general anesthesia 4. pfannenstiel incision exclusion criteria: 1. no history of sensitivity to prescribed analgesic (bupivacaine or related substances) 2. no preeclampsia 3. no history of psychologic disorders

Keywords: transversus abdominis block postoperative pain cesarean
effects of exercise therapy and soft brace on knee osteoarthritis

Conditions: Rehabilitation; Treatment Outcome; Pain; Knee Brace; Outcome Assessment (Health Care); Recovery of Function; Patient Reported Outcome Measures; Adults; Osteoarthritis, Knee

Summary: the primary aim of the study is to investigate the effects of supervised exercise therapy and education on the immediate response to using a soft knee brace in patients with knee osteoarthritis (oa).

study type: observational estimated enrollment: 40 participants observational model: cohort time perspective: prospective inclusion criteria: assigned for exercise and education due to knee osteoarthrosis age 18 years or older at the time of recruitment able to read and understand danish exclusion criteria: not mentally able to reply to the questionnaire patients are tested with and without the brace before starting the exercise therapy and education program and re-tested with and without the brace after completing the treatment program (6 weeks) and again at 12 weeks.

Eligibility criteria:
inclusion criteria: assigned for exercise and education due to knee osteoarthrosis age 18 years or older at the time of recruitment able to read and understand danish exclusion criteria: not mentally able to reply to the questionnaire
a study to evaluate alks 5461 in subjects with major depressive disorder (mdd)

Conditions: Major Depressive Disorder

Summary: this study will evaluate the efficacy of alks 5461 when administered daily for 4 weeks to adults with major depressive disorder (mdd) and inadequate response to antidepressant therapy.

the study will measure efficacy using the ham-d-17, the madrs, and the cgi-s as well as using other scales and assessments.

Eligibility criteria:
inclusion criteria: * diagnosed with a major depressive episode (mde) * body mass index less than or equal to 40 kg/m2 * have been treated with an adequate dose of ssri/snri during the current mde for at least 8 weeks, with the same, adequate dose over the last 4 weeks that is expected to remain stable throughout the study * history of inadequate response during the entire current mde to 1 or 2 adequate antidepressant treatments, including current treatment * be otherwise physically healthy exclusion criteria: * have an axis i diagnosis of delirium, dementia, amnestic or other cognitive disorder, schizophrenia or other psychotic disorder, bipolar i or ii disorder, eating disorder, obsessive-compulsive disorder, panic disorder, acute stress disorder, or posttraumatic stress disorder * have a clinically significant current axis ii diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder * are experiencing hallucinations, delusions, or any psychotic symptomatology in the current mde * receive new onset psychotherapy within 6 weeks of screening * use of opioid agonists (eg, codeine, oxycodone, morphine) within 14 days before screening * have received electroconvulsive therapy during the current mde * have attempted suicide within the past 2 years * have a thyroid pathology * have a history of a seizure disorder or of neuroleptic malignant syndrome/serotonin syndrome * have a positive test for human immunodeficiency virus (hiv) additional inclusion/exclusion criteria may apply
balanced volume replacement therapy with ringer's acetate solution in burn injury

Conditions: Severe Burn Injury

Summary: this observational study compares the influence of ringer's lactate solution and ringer's acetate solution on organ function scores following severe burn injury.

in the early period following severe burn injury volume replacement with high amounts of crystalloids is necessary. in this study we compare the organ function scores of a historical patient group, treated with ringer's lactate solution, with an actual patient population, treated with ringer's acetate solution.

Eligibility criteria:
inclusion criteria: * age \>=18 years and \<80years * burned surface area \>20% and \<70% * burn injury \< 24 hours * agreement to the study procedures exclusion criteria: * burned surface area \> 70% * expected survival time \< 24 hours * acute or chronic heart failure nyha iii or iv * adult respiratory distress syndrome * renal failure * hepatic failure

Keywords: burn injury volume replacement ringer's lactate solution ringer's acetate solution volume replacement with crystalloids