Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of rx-10045 ophthalmic solution for ocular inflammation and pain in cataract surgery

Conditions: Inflammation; Pain; Cataract

Summary: the primary objective of this study is to assess the efficacy and safety of 2 concentrations of rx-10045 ophthalmic solution, 0.05% and 0.1%, compared to placebo for the treatment of ocular inflammation and pain in subjects undergoing cataract surgery.


Eligibility criteria:
inclusion criteria: * unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation in the capsular bag. exclusion criteria: * any additional surgical procedures at the time of the cataract surgery * refractive surgery in the study eye within the past 2 years * history or presence of noninfectious inflammatory ocular disease (e.g., episcleritis, scleritis, uveitis) in either eye * intraocular pressure of \> 21 mm hg in either eye * proliferative or severe nonproliferative diabetic retinopathy in either eye * neovascular/wet age-related macular degeneration in either eye
economic burden of nafld

Conditions: Non-Alcoholic Fatty Liver Disease; NAFLD

Summary: to determine the economic burden of nafld (non-alcoholic-fatty-liver disease) patients in belgium, flanders by means of a bottom-up approach.


Eligibility criteria:
inclusion criteria: * having nafld as was diagnosed by fibroscan®, * 18 years or older * bmi ≥ 25 kg/m² exclusion criteria: * unable to give informed consent * \>70 years
expression & epigenetic silencing of microrna for predicting therapeutic response and prognosis of hpv-negative hnscc

Conditions: Head and Neck Squamous Cell Carcinoma

Summary: a two-part molecular epidemiological study will be conducted to comprehensively assess the association between mir expression and mir promoter methylation and the response to therapy and prognosis in primary, hpv-negative hnscc patients. part 1 will be a prospective collection of 25 pairs of fresh tumor-distant normal mucosal tissue in patients with hnscc. ultimately, 15 hpv-negative tumor-mucosal pairs will be utilized for discovery work in identifying mirs whose expression is up- or down-regulated in tumors. part 2 will test the association between mir expression and mir promoter methylation, and therapeutic response and survival in all archived surgical cases of hpv-negative hnscc at university of new mexico hospital (unmh) collected after 1990.

\* part 1, prospective collection of fresh tumor-distant normal pairs the investigators will prospectively collect 25 pairs of fresh hnscc tumor-distant normal mucosal tissue. \* part 2, retrospective molecular epidemiology study of the association of mirs with therapeutic response and prognosis in hnscc. the investigators will comprehensively test the association between mir expression and mir promoter methylation, and the response to therapy and survival in all cases of surgical hpv-negative hnscc at unmh collected after 1990. lip and nonkeratinizing nasopharyngeal cases will be excluded as these are etiologically distinct and related to cutaneous scc or to eb virus infection, respectively. no cases will be excluded due to gender, age, race or ethnicity.

Eligibility criteria:
inclusion criteria: * patients with a known or suspected diagnosis of hnscc * any primary site may be included, except nonkeratinizing nasopharyngeal scc or lip scc. * patients are planned for diagnostic biopsies for suspected hnscc, or for therapeutic surgery for hnscc. * patients are naïve to radiation to the head and neck, prior to research biopsies. * patients have not received chemotherapy for the diagnosis of hnscc, prior to research biopsies. * age \> 18 years. * eastern cooperative oncology group (ecog) performance status of 0-2. * patients sign an informed consent, agreeing to fresh tumor biopsy as well as distant normal mucosal biopsy for purposes of described research. research biopsies will be in addition to planned surgery. in cases where tumor resection is planned, a representative part of the tumor will be submitted for research purposes. exclusion criteria: * nonkeratinizing nasopharyngeal carcinoma * lip squamous cell carcinoma
a study exploring the safety, tolerability and efficacy of a 4 week course of incb018424 in subjects with active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to understand the safety and tolerability of incb018424 in patients with rheumatoid arthritis


Eligibility criteria:
inclusion criteria: 1. established diagnosis of rheumatoid arthritis 2. patients receiving methotrexate must be treated with for at least 6 months and receiving a stable weekly dose between 10 and 25 mg for at least 8 consecutive weeks prior to study entry. exclusion criteria: 1. patients who have taken the following drugs within the timeframe below: * leflunomide, infliximab, etanercept, adalimumab, abatacept, or other biological therapies (except rituximab) - within 12 weeks prior to the first dose of study medication; * rituximab - within 12 months prior to the first dose of study medication; * disease-modifying anti-rheumatic drugs (dmards) or other anti-rheumatic therapies not specified above including but not limited to: gold, penicillamine, dapsone, azathioprine, 6-mercaptopurine, chlorambucil, cyclophosphamide, cyclosporin, mycophenolate mofetil - within 12 weeks prior to the first dose of study medication; 2. treatment with any investigational medication within 12 weeks prior to the first dose of study medication.

Keywords: rheumatoid arthritis
preconceptional thyroid screening and childhood nerocognitive function

Conditions: Hypothyroidism

Summary: to assess the effect of universal preconception hypothyroidism for maternal pregnancy outcome, and 0-3yrs offspring neurocognitive ability and iq score.

epidemic evidence and animal studies suggested that hypothyroidism is related with maternal pregnancy outcome, offspring cognitive ability. negro's study found improved maternal health in those screened in early trimester; while lazarus et al. reported no significant offspring iq score at 3yrs in universal screening in early trimester. currently, it lacks evidence of universal pre-conception screening for maternal pregnancy outcome and offspring cognitive development, motivation ability, attention. china governmental health department has included thyroid function screening into preconception in 2011. the investigators hypothesize that pre-conception effective treatment may be helpful for decrease possible negative effects on maternal and offspring health, instead of early trimester.

Eligibility criteria:
inclusion criteria: 1. preconceptional group：tsh ≥ 97.5%th and/or ft4 ≤ 2.5%th 2. age: 18-55 3. those who can obey the rules of this study and assign the consent exclusion criteria: 1. age: less than 18 or more than 55 2. multiple pregnancy 3. thyroid tumor disease history 4. those who cannot obey the rules of this study

Keywords: preconception hypothyroidism neurocognitive development
treatment with olverembatinib in cml-cp patients who failed to at least two previously administered second-generation tkis.

Conditions: Olverembatinib; Chronic Myeloid Leukemia, Chronic Phase; Tyrosine Kinase Inhibitors

Summary: the purpose of this trial is to evaluate the efficacy and safety of olverembatinib(hqp1351) in patients with chronic myeloid leukemia in chronic phase (cml-cp) who are resistant and/or intolerant to at least two second-generation tyrosine kinase inhibitors. the efficacy of olverembatinib is determined by evaluating the major molecular responses(mmr) at the and of 12 months.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years and ≤75 years. * diagnosis of cml-cp. * ecog performance of 0-2. * adequate end organ function defined as the following: total bilirubin \<1.5xuln, sgpt \<2.5x uln, creatinine \<1.5x uln. * resistance and/or intolerance of at least two second-generation tkis. * patients must sign an informed consent form (icf) indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital. exclusion criteria: * known to be allergic to study drug ingredients or their analogues. * history of undergone major surgery within 4 weeks. * patients unwilling or unable to comply with the protocol. * pregnant or breast-feeding patients. * patients with other malignant tumor.

Keywords: olverembatinib, cml-cp
thymosin alpha 1, interferon alpha, or both, in combination with dacarbazine in patients with malignant melanoma

Conditions: Malignant Melanoma

Summary: the purpose of the study is to test safety and efficacy of different doses of thymosin alpha 1 (1.6 mg, 3.2 mg, and 6.4 mg) in combination with dacarbazine and with or without interferon alpha in treating patients affected by stage iv melanoma. primary end-point is tumor response evaluated according to response evaluation criteria in solid tumors (recist). secondary end-points are overall survival and progression free survival. ninety-five patients are allocated to each arm to test the hypothesis that p0 \ = 0.15 (alpha = 5%, within-group statistical analysis beta = 95%).


Eligibility criteria:
inclusion criteria: * have read and signed the informed consent form * 18 years \<=age\<= 75 years * adequate contraception practice (fertile female patient) * confirmed diagnosis of metastatic melanoma (stage iv) with unresectable metastases and \>= 1 measurable lesion * adequate renal function as demonstrated by serum creatinine level \< 1.5 mg/deciliter (dl) * absolute neutrophil count (anc) \>= 1.5 x 10000000000/l ; platelets \>= 100 x 10000000000/liter (l) * good performance status: ps \<= 1 (zubrod-ecog-who scale) * at least 12 week life expectancy exclusion criteria: * clinical diagnosis of autoimmune disease * transplant recipient * pregnancy documented by a urine pregnancy test or lactation * previous treatment with thymosin alpha 1 * previous treatment with chemotherapy * presence of central nervous system (cns) metastases * concomitant or prior history of malignancy other than melanoma * participation in another investigational trial within 30 days of study entry * active infectious process that is not of self-limiting nature
pet partners for promotion of academic life skills

Conditions: Stress Prevention; Cortisol; Anxiety Disorders and Symptoms; Depression Disorders and Symptoms; Executive Functioning; Motivation and Learning; Momentary Emotion; Study Strategies; Perceived Stress; Animal Behavior; Animal Stress; Dyadic Interaction; Alpha-amylase

Summary: the current study utilized a randomized controlled trial, conducted in a real-life setting, to determine whether, how, under which conditions, and for whom, infusing various levels of human-animal interaction (hai) in a 4-week, university-based stress prevention program provides an effective approach to prevent negative ramifications of university students stress, promote student executive functioning and learning, while safeguarding animal welfare. this study will examine effects of sole exposure to evidence-based stress prevention content, hands-on hai with registered pet partner teams, or combinations thereof on students' moment-to-moment well-being and longer-term functioning in socioemotional, cognitive and physiological domains.this study will also develop a comprehensive coding system and measure the dynamic nature of behavior of participants, handlers and animals during university- based animal assisted activities, as well as the hai environment. the data and analyses will then be utilized to inform the development of a quantitative measure to capture of the quality of human animal interaction in various settings to experimentally determine causal pathways underlying program effects on humans and animals.


Eligibility criteria:
inclusion criteria: * current enrollment at the campus exclusion criteria: * children under 18 years old * prior history of animal abuse * participation in an an academic stress management workshop within 6 months of study participation
effect of slow-release melatonin (circadin®) therapy on idiopathic rbd: a pilot study

Conditions: REM Sleep Behavior Disorder

Summary: to evaluate effect of slow-release melatonin (circadin) on rem sleep behavior disorder.

investigators planned to administer low (2mg) and high (6mg) dose slow-release melatonin and the placebo for 4 weeks and evaluate clinical global impression scale, rbd questionnaire, psqi, epworth sleepiness scale, and quality of life questionnaire (sf-36v2) before and after the treatment along with possible side effects and drug compliance.

Eligibility criteria:
inclusion criteria: * rem sleep behavior disorder according to icsd-3 criteria * no cognitive deficit or symptom of parkinsonism * those with written consent. exclusion criteria: * who took medication (ex. clonazepam) for rem sleep behavior disorder * with degenerative neurologic disorder (ex. parkinson's disease, multiple system atrophy, lewy-body dementia, etc.) * who took medication that can affect rem sleep behavior disorder (anti-depressant: ssri, tca, mao-inhibitor) * who is unable to answer questionnaires * who have hypersensitive reaction to medications * pregnant women or breastfeeding * who are diagnosed with other parasomnia disorder * with severe medical disorder (severe liver failure, respiratory failure, heart failure, malignant tumor, etc.)

Keywords: rem sleep behavior disorder melatonin
sublingual immunotherapy in children with allergic rhinitis

Conditions: Allergic Rhinitis

Summary: the purpose of this study is to evaluate the clinical efficacy and mucosal/systemic antibody response changes after slit using house dust mite allergen with or without bacterial extracts in mite-allergic children.

patients with allergic rhinitis with or without asthma were selected for a randomized double-blind, placebo-controlled trial and distributed into three groups: dpt (dpt allergen extract, n=34), dpt+mrb (dpt allergen plus mixed respiratory bacterial extracts, n=36), and placebo (n=32). clinical evaluation and immunological analyses are being carried out before and after 12 and 18 months of treatment, including rhinitis/asthma symptom and medication scores, skin prick test (spt) to dpt, and measurements of dpt-, der p 1-, der p 2-specific serum ige, igg4, igg1 and -specific salivary iga.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of allergic rhinitis * positive skin test to dermatophagoides pteronyssinus total extract * positive serum levels of specific ige to d. pteronyssinus extract exclusion criteria: * previous allergen immunotherapy * use of antihistamines 1 week or topical corticosteroid up to 3 weeks prior to skin prick test * long term use of systemic corticosteroid. * airway infection 30 days prior to the selection. * children with severe asthma, malignant, cardiovascular or autoimmune diseases, under chemotherapy or immunosuppressor therapy. * users of cigarette smoke * presence of severe skin lesions

Keywords: iga antibody ige antibody igg1/igg4 subclasses mite allergy sublingual immunotherapy saliva
the prognostic impact of the neutrophil to lymphocyte ratio in patients with locally advanced rectal cancer

Conditions: the Prognostic Value of Pre-treatment NLR in Patients With Locally Advenced Rectal Cancer and Post-treatment

Summary: in this study, we aim to investigate the prognostic value of pre-treatment nlr in patients with locally advenced rectal cancer and post-treatment

colorectal cancer (crc) is the third most common malignancy and the second leading cause of cancer-related death worldwide.\[1\] rectal cancer accounts for 30% to 35% of crcs\[2\], between 5% and 10% of patients with rectal cancer present with locally advanced rectal cancer (larc),\[3\] useful and practical prognostic biomarkers obtained before treatment are anticipated to predict the outcome after main treatment. such biomarkers will help in planning strategies for adjustment of postoperative adjuvant therapy.\[4\] inflammation-induced markers play an important role in tumorigenesis and tumor progression. more evidences had reported systemic inflammation-based biomarkers could be used to predict tumor behavior.\[4\] two convenient and economic measures of systemic inflammation, neutrophil-to-lymphocyte ratio (nlr) and platelet-to-lymphocyte ratio (plr), that reflect the interaction between inflammation and host immune status, making them potential prognostic factors for various types of cancers. increased nlr has been advocated to be an independent prognostic factor for poor survival outcomes in pancreatic cancer, crc, and gastric cancer \[5-6\]. in this study, we aim to investigate the prognostic value of pre-treatment nlr in patients with locally advenced rectal cancer and post-treatment

Eligibility criteria:
inclusion criteria: - patients aged 18-year-old or more 2-histopathologically proved to be rectal carcinoma. 3- locally advanced stage ii and stage iii according to ajcc tnm staging 8th edition 4- fit for concurrent chemoradiation therapy (ccrt) with adequate organ function. 5- performance status 0-1 according to ecog ps exclusion criteria: * 1- metastatic disease 2- younger than 18 year old 3-any other malignancy 4-there is contraindication for ccrt
relaxation response training to treat hypertension

Conditions: Hypertension

Summary: interventions such as relaxation response appear to have widespread effects on physiology. endothelial function, changes in genomic expression, several biomarkers have been associated with chronic stress and cardiovascular dysfunction, and there is some suggestion that elicitation of the relaxation response may lead to improvement in-or normalization of-these factors. by studying the impact of the relaxation response on endothelial function, genomic expression and biomarkers among subjects with hypertension, it may be possible to better understand the biologic underpinnings of relaxation response-type interventions. furthermore, with a greater understanding of the physiologic mechanisms by which the relaxation response works, it may be possible to better target other symptoms and conditions that can be effectively treated by such an intervention.


Eligibility criteria:
general inclusion criteria: * healthy men and women * hypertension (stage 1) * 18-70 years old general exclusion criteria * no asthma or nasal allergies * non-smokers * if on anti-hypertensive medication willing to discontinue * cannot currently practice tai chi, meditation, or yoga regularly * current use of the following medications: phosphodiesterase type 5 inhibitors, long-acting nitrates, systemic corticosteroids, anti-inflammatories, immunosuppressive or cytotoxic therapies (currently or within the last 12 months), anabolic steroids, and antidepressants.

Keywords: stage 1 hypertension
double-blind, placebo-control, study to evaluate the safety and pharmacokinetics of ct-044 hcl, in healthy volunteers

Conditions: Acute Pain; Pain, Acute; Surgery; Neuropathy

Summary: this study will be conducted to assess safety, tolerability, and pk of ct-044 hcl in normal healthy volunteers, in a traditional sequential multiple ascending dose paradigm. the multiple-dose escalation is designed to mimic the manner in which the product (ct-044 hcl) would be used to manage ongoing pain in patients (i.e., multiple dosing).

subjects meeting all inclusion and exclusion criteria will be randomized to receive ct-044 hcl or placebo in three successive dose escalating cohorts of 8 subjects each (2 placebo and 6 active drug per dose level). subjects will receive multiple oral ct-044 hcl doses for 7 days. subjects will be monitored in-house for vital signs, physical examination, electrocardiogram (ecg), safety laboratory testing and documentation of adverse signs and symptoms. serial blood and urine samples will be collected to evaluate ct-044 hcl levels in plasma and urine. eligible subjects will be admitted to the clinical trial unit on the day prior to dosing (day -1) and remain in house until day 9 (discharge day). subjects will return to the clinical trial unit on an outpatient basis for follow-up (day 13, ± 1 day).

Eligibility criteria:
inclusion criteria: * body mass index within the range 18.5 to 32.0 kg/m2 (inclusive). * healthy subjects as determined by medical history, physical examination including neurological examination, vital signs, electrocardiogram (ecg), and clinical laboratory tests. * negative tests for hepatitis b surface antigen, hepatitis c virus antibodies and human immunodeficiency virus (hiv-1 or hiv-2) antibody, and syphilis. * nonsmokers (use of any nicotine containing product) or ex-smokers (have ceased smoking for at least 3 months and do not use any drug for smoking cessation. * negative screen for alcohol and drugs of abuse. * women must not be of childbearing potential by reason of surgery or at least 1 year post-menopausal (i.e., 12 months without menstrual period), or menopause. * men must be infertile (at least 3-months post-vasectomy), or truly abstinent of heterosexual intercourse, or heterosexual partner is not of childbearing potential or must agree to use an effective method of contraception. men must agree to not provide sperm donation during that same period. * able and willing to be available for the duration of the study. * willing and able to give written informed consent to participate. * able to understand and comply with protocol instructions.

Keywords: safety tolerability escalation pharmacokinetics pk ct-044 hcl ascending plasma surgical pain acute pain non-opioid neuropathy chronic neuropathy
impact of dietary fiber as prebiotics on chemotherapy-related diarrhea in patients with gastrointestinal tumors

Conditions: Chemotherapy-related Diarrhea

Summary: this study evaluates longitudinal data associating changes in gut microbiota composition and diversity, defecation, performance status and adverse reactions in response to prebiotic fiber supplementation in patients with gastrointestinal cancer chemotherapy-related diarrhea. 120 adult participants , age 18 to 65 years, will be randomized into one of the two arms. arm a (intervention group) will receive prebiotic fiber and loperamide hydrochloride capsule(a drug for standard treatment). arm b will receive maltodextrin placebo and loperamide hydrochloride capsule.


Eligibility criteria:
inclusion criteria: * age 18-65, be able to comply with the protocol * life expectancy greater than 3 months * patients with cytologically or histologically confirmed diagnosis of gastrointestinal cancers * undergoing chemotherapy, not synchronized with radiotherapy and other anti-tumor treatments * chemotherapy-related diarrhea grade 2-4 * not experience diarrhea before chemotherapy exclusion criteria: * age\ 65 * patients who cannot eat by mouth for example chewing disorders, difficulty swallowing, intractable vomiting, gastrointestinal obstruction or gastrointestinal tract bleeding * other acute or chronic diarrhea or colostomy * patients with other severe adverse effects of chemotherapy other than diarrhea * patients with severe diseases of heart, kidney, liver and other major organs * use of any other drug for promoting intestine movement * use of any other drug or dietary supplement for chemotherapy-related diarrhea such as other fiber supplements, probiotics, octreotide * allergic to the components of the intervention dietary supplements; * pregnancy (positive serum pregnancy test) and lactation * any other serious or uncontrolled illness which the investigator think is undesirable for the patient to enter the trial