Kornimate/medical-research-clean huggingface dataset:
efficacy, safety and tolerability of agomelatine sublingual tablets in the treatment of major depressive disorder (mdd)

Conditions: Major Depressive Disorder

Summary: the study will assess efficacy, safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine in patients with major depressive disorder. this study includes an 8-week double-blind phase.


Eligibility criteria:
inclusion criteria: * patients with diagnosis of mdd, single or recurrent episode, according to dsm-iv criteria. * current episode ≥4 weeks. * cgi-severity score ≥4 at screening and baseline. exclusion criteria: * history of bipolar disorder (i or ii), schizophrenia, schizoaffective disorder, eating disorder (current or during previous one year), obsessive-compulsive disorder. * any other current axis i disorder other than mdd which is the focus of treatment. * substance or alcohol abuse in the last 30 days, dependence in the last 6 months. * concomitant psychotropic medication, including herbal preparations and melatonin. * psychotherapy of any type. * prior exposure to agomelatine. * female patients of childbearing potential who are not using effective contraception. other protocol-defined inclusion/exclusion criteria may apply

Keywords: agomelatine major depressive disorder mdd depression
hpv vaccine hesitancy among indiana youth with cancer and blood diseases

Conditions: Human Papilloma Virus Vaccine Hesitancy

Summary: for the identified groups of patients (survivors of childhood cancer and youth with sickle cell disease) the investigators want to better understand the barriers to, and facilitators of, hpv vaccination. through hcp interviews the investigators will also assess both attitudinal and logistical obstacles to hpv vaccination. some subspecialty hcps may believe, for instance, that it is the primary care provider's responsibility to vaccinate or they may be unfamiliar with the requirement to enter vaccination data into chirp. also, in some cases hpv vaccine may not be readily available in subspecialty clinic locations and/or subspecialty hcps may not be vaccines for children (vfc) providers. participants: the investigators will focus on two patient groups: survivors of childhood cancer, which includes children aged 9-21 years who have completed active therapy for cancer and are eligible for vaccination, and sickle cell disease, which includes children aged 9-21 years with a diagnosis of sickle cell disease. the investigators will recruit parents of children aged 9-21 years and older adolescents aged 18-21 years. for pediatric patients, the investigators selected a lower age of 9 years because hpv vaccine is licensed down to 9 years of age, and an upper limit of 21 years, as that is considered the upper bound of adolescence by the american academy of pediatrics. for patients 9-17 years of age, only parents will be interviewed by video or phone because parents are the vaccine decision-makers. for patients 18-21 years of age, the investigators will interview both young adults and their parents, because, while the young adult has legal decision-making capacity, in reality, the decision is frequently made jointly by the young adult and parent, and older adolescents are frequently unwilling to go against their parents' wishes. all research procedures will be conducted in english. participants will be excluded if they have an intellectual disability or severe medical illness such that they are unable to consent or to understand the questions.


Eligibility criteria:
inclusion criteria: * age 9-21 years of age for patients with sickle cell disease or cancer. * caregiver of patient with sickle cell disease or cancer. * healthcare provider of patient with sickle cell disease or cancer. exclusion criteria: * n/a
post burn pruritus study in patients undergoing wound healing

Conditions: Itching

Summary: the purpose of this study is to see if a drug called ondansetron (zofran) controls itching from healing burn wounds as well or better than the usual drug used, diphenhydramine (benadryl).

a clear mechanism or cause for pruritus in patients recovering from burn has not been delineated. while the exact mechanisms/pathways for itching are currently unclear, histamine antagonism appears to be the most popular treatment. whether histamine antagonism works predominantly via peripheral inhibition or central sedation is uncertain. by treating another intermediary in the pruritus cascade, it may be possible that an alternate treatment could be used while eliminating some of the unwanted side effects of antihistamine at the same time.

Eligibility criteria:
inclusion criteria: * males or females; 18 years or older. * seen in the united states army institute of surgical research (usaisr) burn clinic with healing burn wounds of any percent (%) of total body surface area (tbsa) causing pruritus * stable medical condition * negative pregnancy test and not nursing * able to indicate status of pruritus on a numeric scale * able to understand and read english exclusion criteria: * unstable medical condition as determined by attending burn surgeon * prisoner * history of allergic reaction to serotonin inhibitors or diphenhydramine * pregnant or lactating * unable to verbalize pruritus intensity scale * unable to understand or read english

Keywords: pruritus burn wound
autonomic nervous system (ans) and renal function in immunoglobin a (iga) nephropathy

Conditions: IGA Glomerulonephritis

Summary: the estimation of the cardiovascular risk in the general population must take into account small renal disturbances, as the microalbuminuria. conversely certain parameters of the cardiovascular risk influence the evolution of renal diseases, for example the arterial high blood pressure. the measure of the activity of the autonomous nervous system, and especially the quantification of its variability, is a means to estimate the cardiovascular risk. the investigators formulate the hypothesis that the variability of the autonomous nervous system is an additional clinical element for the evaluation of the evolutionary risk of renal diseases. the aim of this study is to compare the variability of the autonomous nervous system during the various evolutionary stages of the renal disease. the renal disease studied will be iga nephropathy (igna). igna is a histologically defined glomerulonephritis (rela biopsy) by the presence of deposits immunoglobulin a (iga) in the renal mesangium (at list 1+) by immunofluorescence.


Eligibility criteria:
inclusion criteria: * diagnosis of igna biopsy-proven free, informed, express and written exclusion criteria: * igna secondary to henoch-schonlein purpura (hsp) or systemic lupus erythematosus or alcoholic cirrhosis * current kidney transplantation * hypertension treated or not, * diseases interfering with ans analysis: cardiac arrhythmia, beta-blocker therapy * diabetes

Keywords: iga glomerulonephritis autonomic nervous system ans
study of use of pemetrexed in patients with non-small lung cancer metastatic in andalusian public health system

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: study of use of pemetrexed in patients with non-small lung cancer metastatic in andalusian public health system


Eligibility criteria:
inclusion criteria: * patients over 18 years * confirmed diagnosis of metastatic nsclc * pemetrexed starts 1st line (either induction or maintenance) in any of the following periods: * january 1, 2010 to march 31, 2010 * october 1, 2011 to december 31, 2011 exclusion criteria: * patients receiving pemetrexed within a clinical trial protocol because it is an experimental environment that does not reflect clinical practice.
clinical study of ak159 in healthy postmenopausal women

Conditions: Osteoporosis

Summary: the objective of this study is to investigate the pharmacokinetics, safety, and tolerability of ak159 administered to healthy postmenopausal women.

this study consists of part 1 and part 2. \ part 1 will be conducted according to a single-centre, randomized, single-dose, 3-period, 5-treatment alternating crossover design in two groups of healthy post-menopausal women the pharmacokinetics, safety, and tolerability of a single dose of ak159 (4 levels) will be investigated versus teriparatide acetate for injection as a control. \ part 2 will be conducted according to a multiple-centre, randomized, double-blind, placebo-controlled, repeated dose parallel design of healthy post-menopausal women the pharmacokinetics, safety, and tolerability of ak159 (4 levels) for 8 weeks will be investigated versus teriparatide acetate for injection and placebo as controls. pharmacokinetics, safety, and tolerability following long-term application will also be investigated.

Eligibility criteria:
inclusion criteria: * healthy postmenopausal ethnic japanese women; at least 45 years of age at the time consent is obtained; and give voluntary consent in writing with a sufficient understanding of the study. exclusion criteria: * clinical abnormality identified in the laboratory tests * weight \< 40.0 kg * body mass index \ =30.5 * history of disease of the kidneys, liver, heart, brain, or other organ that makes them ineligible as subjects * previously received radiation treatment potentially affecting bone * systolic blood pressure \< 90 mmhg * qtc exceeds 470 msec in a 12-lead electrocardiography * serum calcium level exceeding 10.4 mg/dl * history of contact dermatitis or skin disease potentially compromising study evaluation * used drugs which impact bone metabolism in the 8-week period preceding investigational product administration * used a bisphosphonate; * used a teriparatide product;

Keywords: ak159 teriparatide acetate
the incidence of gallstones after gastric cancer surgery

Conditions: Gallstones; Gastric Cancer

Summary: through previous clinical observations and literature, we found that the incidence of gallstones in patients after gastric cancer radical resection was significantly higher than that in the normal population (4%). however, its pathogenesis has not been clarified. we compare the risk of gallbladder stones after four different radical gastric cancer surgical methods, in order to provide prevention and treatment strategies for people with gallstones after gastric cancer.

a large number of clinical studies have found that the incidence of gallstones in patients with radical gastric cancer is higher than that in the normal population. however, its pathogenesis has not been clarified, and there is still controversy about the prophylactic removal of gallbladder in patients with gastric cancer. the investigator's previous study found that there was no statistical difference in the incidence of gallstones after laparoscopic distal gastrectomy (ldg), laparoscopic total gastrectomy (ltg) and laparoscopic proximal gastrectomy (lpg). a common feature of the three surgical methods is that the vagus nerve were more or less cut during the operation. therefore, we plan to further collect gastric cancer patients undergoing endoscopic submucosal dissection (esd) surgery in order to answer whether the vagus nerve cut during surgery will increase the incidence of gallstones.

Eligibility criteria:
inclusion criteria: * gastric cancer patients * age from over 18 to under 75 years exclusion criteria: * gallbladder disease before surgery * gallbladder has been remove * history of previous upper abdominal surgery * history of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection * history of other malignant disease within past five years * history of previous neoadjuvant chemotherapy or radiotherapy * history of unstable angina or myocardial infarction within past six months * history of cerebrovascular accident within past six months * requirement of simultaneous surgery for other disease * emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer * pregnant women or breastfeeding * unwillingness or inability to consent for the study * severe mental disorder * unstable vital signs coagulation dysfunction (inr\>1.5) * low peripheral blood platelet count (\<50×10 \^9 / l) or using anti- coagulation drugs

Keywords: gallstones gastric cancer gastrectomy esd vagus nerve
destiffening and hypotensive effects of whole milk and full-fat dairy products

Conditions: Hypertension; Prehypertension

Summary: the specific aim of the proposed study is to address the efficacy of conventional full-fat dairy products as part of the normal routine diet for improving vascular function and reducing blood pressure in middle-aged and older adults with elevated blood pressure. the investigators hypothesize that dietary intervention including whole milk and full-fat milk products will induce significant decreases in systolic blood pressure and arterial stiffness. the investigators also test the hypothesis that the reductions in blood pressure will be associated with the corresponding decreases in arterial stiffness and/or increases in endothelial vasodilatory function as well as improvements in arterial baroreflex sensitivity. if our hypotheses are supported by the results, the information could be used as a basis for recommendations for the use of whole milk and full-fat milk products in the secondary prevention of elevated blood pressure and vascular dysfunction.


Eligibility criteria:
inclusion criteria: * prehypertension or stage-1 hypertension exclusion criteria: * consume \> 3 servings of dairy or fruit per day * strenuous physical activity \> 3 time per week * lactose intolerance, pregnancy, lactation, and/or alcohol abuse * taking cardiovascular-acting drugs * overt cardiovascular disease, metabolic disease, gi disorders and/or renal disease
evaluation of the improvement of quality of life of patients suffering from hailey hailey or darier disease after injections of botulism toxin into large folds.

Conditions: Hailey-Hailey Disease; Darier Disease

Summary: hailey hailey and darier disease are rare genetic dermatoses. mutations of 2 genes (atp2c1 or atp2a2 respectively) are responsible for the diseases. these genes have a key role in calcium pump; their defect create abnormal link between keratinocytes' desmosomes and induce skin lesions. clinically, patients present with inflammatory lesions located in the folds. quality of life is impaired because of pain, pruritus and tendency to infections. lesions are permanent but acute exacerbations occur in hot seasons because of increased sweating. usual therapies are often not effective (local treatment, laser, phototherapy). because sweating is a well established inducing or aggravating factor, botulism toxin could be an effective treatment for these diseases. botulism toxin is already used in clinical practice and acts via a decreased sweet secretion. improvement of skin lesions in hailey-hailey or darier diseases has been previously reported in a few cases but there is no study properly evaluating the benefit of such treatment. the aim of the project is to study the improvement of quality of life for patients suffering from hailey-hailey or darier diseases after a injections of botulism toxin in large skin folds. the principal objective is to estimate the distribution of the variation of quality of life at m1 vs. baseline.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis (clinical and histological features) of hailey hailey or darier diseases. * moderate to very severe lesions located in large folds * patient aged 18 ans or more * patient with health coverage * patient who have signed the consent form * patient proficient into filling out the questionnaires. exclusion criteria: * hypersensibility to toxin or excipients * myastheny * deglutition's problems * past medical history of dysphagia or aspiration pneumonia * pregnancy (positive b-hcg test performed a maxima 72h before) or breastfeeding * mental , physical incapacity to fill in the questionnaires * guardianship patients * skin infections at the inclusion visit * application in the last 7 days at the site of injection of local treatments (apart emollients or antiseptics) or injections of botulism toxin or dynamic phototherapy or laser in the last 6 months. * systemic treatment with aminosides in the last 15 days * inclusion in another study in the last 2 months.

Keywords: botulism toxin
clinical study to evaluate the pharmacokinetics, safety, tolerability and pharmacodynamic effects of a single and multiple oral bay1101042 tablet doses in healthy male subjects

Conditions: Healthy Volunteer

Summary: to investigate the safety, tolerability, pharmacokinetics and effects of bay1101042 in healthy male subjects after a single oral dose and multiple once daily dosing for 7 days


Eligibility criteria:
inclusion criteria: * the informed consent must be signed before any study specific tests or procedures are done. * healthy male subject. * age: 18 to 45 years (inclusive) at the screening. * body mass index (bmi): above/equal 18 and below/equal 29.9 kg/m2. * ability to understand and follow study-related instructions. exclusion criteria: * pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal. * subjects with thyroid disorders as evidenced by assessment of thyroid stimulating hormone (tsh) levels outside the normal reference range at screening. * regular use of medicines. * smoking more than 10 cigarettes daily. * systolic blood pressure below 100 or above 145 mmhg (at screening). * diastolic blood pressure below 50 or above 90 mmhg (at screening). * heart rate below 50 or above 90 beats/ min (at screening).

Keywords: chronic kidney disease
a study to assess the effect of cc-95251 in participants with acute myeloid leukemia and myelodysplastic syndromes

Conditions: Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Summary: the purpose of this study is to evaluate the safety, tolerability, and preliminary clinical activity of cc-95251 alone and in combination with antineoplastic agents in participants with relapsed or refractory acute myeloid leukemia and relapsed or refractory and treatment-naive higher risk melodysplastic syndromes.


Eligibility criteria:
inclusion criteria: • eastern cooperative oncology group performance status of 0 to 2 for parts a \& b: * relapsed or refractory (r/r) acute myeloid leukemia (aml) as defined by the 2016 who classification * r/r myelodysplastic syndromes (mds) as defined by the 2016 who classification with intermediate, high or very high risk by revised international prognostic scoring system (ipss-r) for part c: • treatment-naïve (tn) (ie, previously untreated) mds as defined by the 2016 who classification with intermediate, high or very high risk by ipss-r for part d: • tn aml as defined by the 2016 who classification, including secondary aml and therapy-related aml in participants who are ineligible (ie) for intensive chemotherapy (ic) and allogeneic hematopoietic stem cell transplant (hsct) exclusion criteria: * acute promyelocytic leukemia * immediately life-threatening, severe complications of leukemia such as disseminated/uncontrolled infection, uncontrolled bleeding, and/or uncontrolled disseminated intravascular coagulation * participants who have received prior treatment with a cd47 or sirpα targeting agent * participant is on chronic systemic immunosuppressive therapy or corticosteroids * prior systemic cancer-directed treatments or investigational modalities ≤ 5 half-lives or 4 weeks prior to starting study treatment, whichever is shorter (relapsed or refractory participants only). * any condition including, active or uncontrolled infection, or the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study * pregnant or nursing participants. other protocol-defined inclusion/exclusion criteria apply

Keywords: myelodysplastic syndromes acute myeloid leukemia aml mds hematologic cancers leukemia anti-sirpa antibody cc-95251
a retreatment study with bortezomib for multiple myeloma

Conditions: Multiple Myeloma

Summary: the purpose of this study is to monitor such factors as a past history, a previous history of drug use, the degree of response to initial treatment, the frequency of previous therapies, age, eastern cooperative oncology group (ecog) performance status, which is used by doctors and researchers to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis, before the bortezomib re-treatment, the concomitant drugs that are used for re-treatment and the pattern of treatment in patients with multiple myeloma who were re-treated with injectable bortezomib.

it will be essential to obtain the korean clinical data about the efficacy and safety of the re-treatment with bortezomib as well as to analyze its actual pattern. the current trial is a prospective, multi-center, phase 4, observational study that will be conducted to collect such demographic data as a past history, a previous history of drug use, the degree of responses to initial treatment, the frequency of previous therapies, age, eastern cooperative oncology group (ecog) performance status, the concomitant drugs that are used for re-treatment and the pattern of treatment for patients with multiple myeloma and who were re-treated with injectable bortezomib. also safety data will be collected. observational study -no investigational drug administered

Eligibility criteria:
inclusion criteria: * patients with multiple myeloma * patients who were treated with bortezomib monotherapy or bortezomib combination therapy * patients who relapsed after \>= six months interval since last dose of bortezomib * patients who had a treatment response of higher than partial remission (pr) to the previous bortezomib therapy * patients who were fully aware of the objectives and essential procedures of the current trial and then submitted a written informed consent declaring that they will voluntarily participate in the current trial exclusion criteria: * the current presence of or a past history of hypersensitivity to bortezomib or its constituents * severe hepatic dysfunction (ast or alt at first use\>= x 5 upper normal) * pregnant women

Keywords: bortezomib retreatment velcade proteasome inhibitor bortezomib
the women's urology center/wish database project

Conditions: Interstitial Cystitis; Sexual Dysfunction; Pelvic Pain; Incontinence

Summary: comprehensive database from the women's urology center/wish (women's initiative for pelvic pain and sexual health) program at beaumont.

this women's health database will help us to identify health issues/concerns, useful therapies and interventions, and identify areas for improvement or further research specific for women's health. it will allow evaluation of outcomes of clinical interventions to enhance the care and treatment of women with pelvic pain and sexual health concerns.

Eligibility criteria:
inclusion criteria: all women's urology center or wish patients will be included in this database over time. exclusion criteria: the only exclusion would be if specified by a patient upon consent to treatment in the women's urology center or wish program

Keywords: interstitial cystitis sexual dysfunction vulvodynia pelvic pain incontinence