Kornimate/medical-research-clean huggingface dataset:
a study to investigate using inhaled fexlamose to treat adult participants who have moderate to severe copd

Conditions: COPD

Summary: aer-01-002 is a phase 2a study being conducted to determine if inhaled fexlamose is an effective and safe treatment for adults with moderate to severe copd. study will compare active drug to placebo.


Eligibility criteria:
main inclusion criteria each participant must meet all the following criteria to be enrolled in this study: * participant is male or female ≥40 to ≤80 years of age. * participant has a verified diagnosis of cigarette smoking-related copd fev1 that is \>25% and \<60% of predicted normal at visit 1. * participant meets the following spirometry performance criteria: * acceptability: participant can perform acceptable spirometry (ie, meet ats/ers acceptability criteria) at visits 1 and 2. * repeatability: participant can perform technically acceptable spirometry meeting repeatability criteria for fev1 during at least 1 of the prebronchodilator assessments at visits 1 and 2. * participant is on stable maintenance copd medications with no dose adjustments for ≥4 weeks prior to screening and during the screening period. * participant has had ≤2 copd exacerbations requiring hospitalization in the past year. main exclusion criteria participants meeting any of the following criteria will be excluded from the study: * participant has an active uncontrolled medical condition * participant has a diagnosis of current asthma * participant has primary diagnosis of bronchiectasis, primary ciliary dyskinesia, allergic bronchopulmonary aspergillosis, or cf. * participant has had a copd exacerbation in the 6 weeks prior to visit 1 * participant has active lung infection * participant has received any vaccine within 7 days prior to day 1. * participant is taking a protein therapeutic for control of copd or asthma: eg, dupilumab, tezepelumab, benralizumab, mepolizumab, omalizumab.
prevalence of eating disorder symptomatology among outpatients referred to health promotion from somatic hospital departments

Conditions: Eating Disorders

Summary: the department of health promotion at aalborg university hospital gets patients referred from all the hospital's departments. the department of health promotion offers lifestyle courses to aid preventing disease relapses and further comorbidities to patients referred to other ambulatory treatments at the hospital. for most patients this also includes weight loss, but the primary goal is lifestyle change regarding eating and exercise habits to improve overall health state. since it is known that eating disorders commonly occurs in individuals seeking help for weight loss, and that the prevalence is larger than in the background population, we also suspect that eating disorders would commonly occur among patients referred to the department of health promotion. therefore, we aim to investigate the prevalence of eating disorders among patients referred to lifestyle courses at the department of health promotion.


Eligibility criteria:
inclusion criteria: * patients referred to the department of health promotion at aalborg university hospital, denmark exclusion criteria: * under age 18 * not able to read and understand danish * not able to recieve mail in the danish digital postbox, e-boks
a study of ro4917838 (bitopertin) in patients with sub-optimally controlled symptoms of schizophrenia (wn25305)

Conditions: Schizophrenia

Summary: this randomized, multi-center double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of ro4917838 (bitopertin) in patients with sub-optimally controlled symptoms of schizophrenia. patients, on stable treatment with antipsychotics, will be randomized to receive daily oral doses of ro4917838 or matching placebo for 52 weeks, followed by an optional treatment extension for up to 3 years.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * diagnosis of schizophrenia * clinical stability for 16 weeks (4 months) prior to randomization * antipsychotic treatment stability for the past 12 weeks prior to randomization * with the exception of clozapine, patients are on any of the available marketed atypical or typical antipsychotic (treatment with a maximum of two antipsychotics) exclusion criteria: * has treatment resistant schizophrenia as judged by the treating physician or have failed two trials * evidence that patient has clinically significant uncontrolled or unstable medical disorder (e.g. cardiovascular, renal hepatic, gastrointestinal, hematologic, immunological, neurological, endocrine, metabolic or pulmonary disease) * patient has a body mass index (bmi) of \ 40 kg/m2, respectively) * diagnosis of mental retardation or severe organic brain syndromes * in the investigator's judgment, a significant risk of suicide or violent behavior"
adjunctive therapy of exenatide or sitagliptin to insulin glargine in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: this study investigated a 4-week adjunctive therapy of either a glp-1 analog (exenatide), or a dpp-4 inhibitor (sitagliptin), given to a basal insulin analog (insulin glargine), and their effect on blood glucose control, versus insulin glargine alone as active comparator in type 2 diabetes.

due to the different mechanisms of action of the long-acting insulin analog insulin glargine and both a glp-1 analog (exenatide) and a dpp-4-inhibitor (sitagliptin), it could be a promising approach to combine insulin glargine with either exenatide or sitagliptin for optimum control of fasting and postprandial blood glucose values. thus, in the present study the influence of either exenatide or sitagliptin as a 4-week adjunctive therapy to a basal insulin (insulin glargine) was investigated versus insulin glargine alone as active comparator in subjects with type 2 diabetes. preexisting metformin was continued, sulfonylureas, if any, were stopped. in particular, the effects on postprandial blood glucose excursion following ingestion of a standard breakfast, assessed after 4 weeks of treatment, the effects on mean daily blood glucose, on self-measured 7-point profiles, the percentage of subjects reaching ada treatment goals (hba1c \< 7.0%) at the end of treatment, on fasting lipid profile, on homa index, weight, hypoglycemic episodes and general safety were assessed. the study consisted of a screening visit, a 4-8 week (depending on pre-treatment) run-in period, a 4-week treatment period, and a follow-up visit. there were weekly visits at the site and twice weekly telephone contacts.

Eligibility criteria:
inclusion criteria: * male or female subjects aged between 35 and 70 years, inclusive * type 2 diabetes with duration \>6 months and \<10 years * for at least 3 months: treatment solely with a long- or intermediate-acting insulin formulation (insulin glargine, insulin detemir, or nph insulin) with or without a stable dose of metformin or treatment solely with a stable dose of metformin or combination of stable doses of metformin plus sulfonylureas * hba1c \>=7.0% and \<=10.0% * if treated with antihypertensive or lipid lowering agents, the treatment regimen had to be stable during 3 months prior to study start * written informed consent exclusion criteria: * history or presence of cancer or any clinically relevant diseases * chronic heart failure nyha class iii or iv, unstable angina pectoris or myocardial infarction within the previous 6 months * recurrent hypoglycemia * abnormal lab tests at screening (alat and/or asat \>=3 times uln), creatinine \>1.6 mg/dl in males and \>1.4 mg/dl in females * clinically relevant ecg findings at screening * treatment with a rapid-acting insulin or with a mixed insulin formulation during the previous 3 months * treatment with any other oha than metformin or metformin plus sulfonylureas during the previous 3 months * any systemic or topical treatment with drugs known to influence glucose metabolism

Keywords: type 2 diabetes
study of trc102 in combination with pemetrexed in cancer patients

Conditions: Neoplasm

Summary: this study is being performed to evaluate the safety and tolerability of trc102 in combination with alimta. in addition to safety, this study will also evaluate pharmacokinetics and tumor response.

this study is being performed to evaluate the safety and tolerability of trc102 in combination with alimta. in addition to safety, this study will also evaluate pharmacokinetics and tumor response.

Eligibility criteria:
inclusion criteria: * the patient has given informed consent * the patient is willing and able to abide by the protocol * the patient has cancer and curative therapy is unavailable or standard therapy has failed * the patient is at least 18 years of age * the patient has adequate ability to perform activities of daily living * the patient has recovered from significant toxicities of previous therapy * the patient has adequate organ function as assessed by laboratory testing exclusion criteria: * the patient has had prior treatment with high-dose chemotherapy requiring stem cell rescue * the patient is currently on treatment on another therapeutic clinical trial or has received an investigational drug within 4 weeks prior to first dose on this study * the patient has had prior surgery, radiation or systemic therapy within 4 weeks of starting the study * the patient has a history of cns cancer * the patient has an unstable medical condition including (not limited to) cardiac disease, hiv/aids, history of stroke, hepatitis or significant paricardial, pleural or peritoneal effusion * the patient is pregnant or breastfeeding

Keywords: trc102 methoxyamine hcl pemetrexed alimta tracon phase 1 cancer ber base excision repair small molecule anti-folate solid tumor neoplastic processes pathologic processes pathological conditions, signs and symptoms
implitapide in patients with heterozygous familial hypercholesterolemia (hefh) on maximal concurrent lipid-lowering therapy

Conditions: Familial Hypercholesterolemia

Summary: the purpose of this study is to determine if implitapide, used in conjunction with other lipid-lowering therapies, is safe and effective when compared to placebo in lowering low-density lipoprotein cholesterol (ldl-c) in patients with heterozygous familial hypercholesterolemia (hefh).


Eligibility criteria:
inclusion criteria: in order to participate in this study, patients must meet all of the following inclusion criteria: * be between 18 and 70 years old with a diagnosis of hefh; * be stable on and maintain concomitant therapy with hypolipidemic drugs or treatments; * have an appropriate calculated, fasting ldl-c levels and an appropriate triglyceride (tg) level; * be male or nonpregnant, nonlactating female; * give informed consent; and * meet body weight requirements. exclusion criteria: in order to participate in this study, patients must not meet any of the following exclusion criteria: * recent myocardial infarction, percutaneous transluminal coronary intervention, coronary artery bypass graft surgery, or cerebrovascular accident; * uncontrolled hypothyroidism or other uncontrolled endocrine disease; * known, clinically significant eye abnormalities (e.g., cataracts); * appropriate serum creatinine phosphokinase levels; * history of liver disease or liver enzyme levels above appropriate levels; * alkaline phosphatase above appropriate levels; * serum creatinine above appropriate levels; * liver cirrhosis and severe liver steatosis; * clinically significant infection, malignancy, or psychosis; * use of oral anticoagulants or digoxin, unless the dose has been stable for 4 weeks; * participation in any other investigational study, including device or observational studies, within 30 days; * lactating or have a positive serum pregnancy test; * current drug or alcohol abuse; or * unwillingness to comply with study procedures, including follow-up, as specified by this protocol, or unwillingness to cooperate fully with the investigator

Keywords: heterozygous familial hypercholesterolemia (hefh)
a pharmacokinetic study of mp-214 in patients with schizophrenia

Conditions: Schizophrenia

Summary: the objective of this study is to evaluate the pharmacokinetics, safety and efficacy of mp-214 in patients with schizophrenia.


Eligibility criteria:
inclusion criteria: * written informed consent obtained from the patient before the initiation of any study-specific procedures * patients diagnosed with schizophrenia according to the diagnostic criteria of the diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) criteria for schizophrenia * patients with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ecg) exclusion criteria: * patients with a dsm-iv-tr diagnosis of schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar i or ii disorder the information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: schizophrenia antipsychotic agents mental disorder psychotropic drugs dopamine agents central nervous system agents
the registry study of genetic alterations of melanoma in taiwan

Conditions: Primary Melanoma of the Extremity

Summary: cutaneous melanoma is the most aggressive malignancy in skin cancers. cutaneous melanoma is a rare disease in taiwan with an incidence rate of around 1/100,000. acral lentiginous melanoma is the most common subtype and comprises more than half of cutaneous melanoma in asia including taiwan but only 1% in caucasians. in addition, mucosal melanoma accounts for more than 20% of malignancy melanoma in taiwan but only 1% in caucasians. acral and mucosal melanomas have distinct epidemiological, clinical, pathological and genetic features from non-acral melanoma which is commonly seen in western countries. comparing with melanoma in caucasians, asian melanoma has higher recurrence rate after primary surgery, lower response rate to immunotherapy, and shorter progression-free survival for immunotherapy and targeted therapy leading generally poor survival outcomes regardless stage.

most melanoma patients present with locally advanced or metastatic disease at diagnosis reflecting the aggressive disease nature of melanoma in taiwan. currently, surgical resection of primary tumor and lymph node dissection are the main treatment for patients with locally advanced melanoma. adjuvant therapy should be considered for stage iii melanoma. unfortunately, most patients recur after above aggressive treatment. systemic treatment including targeted therapy, immunotherapy and chemotherapy is the main for unresectable or metastatic melanoma. the prognosis of these patients remains poor with a median survival time around a year. therefore, a better understanding of this deadly disease is crucial and finding better therapeutic strategies for these patients and stratifying patients with suitable treatment are urgent.

Eligibility criteria:
inclusion criteria: 1. age \> 18 years old 2. pathologically confirmed melanoma. (patients with additional malignancies requiring treatment or follow-up are allowed. only treatment for melanoma should be recorded). 3. ecog performance status \< 3 4. cohort 1(early acral melanoma): melanoma, stage i/ii; cohort 2 (locally advanced acral melanoma): melanoma, stage iii, resectable; and cohort 3 (advanced): unresectable / metastatic melanoma, stage iii/iv or recurrent melanoma (unresectable). staging is based on ajcc cancer staging system 8th edition). the patients with advanced melanoma with available comprehensive ngs report are included in cohort 4. 5. willingness to provide archival or newly obtained tumor tissues for this study proposal 6. life expectancy more than 3 months - 7. patients fully understand the protocol with the willingness to have regular follow-up exclusion criteria: 1. inability to cooperate by providing a complete medical history 2. no available tumor tissues for genetic testing (archived tissue sampling more than 5 years from screening date) 3. undesirable compliance (mental status is not fit for further treatment or data collection.)

Keywords: next-generation sequencing acral melanoma mucosal melanoma cutaeous melanoma
perfusion computer tomography: imaging and clinical validation following reperfusion therapy in acute ischaemic stroke

Conditions: Ischemic Stroke

Summary: ct perfusion (ctp) of the brain is an innovative technique to identify rapidly regions which are only partially or insufficiently perfused during an acute ischemic event. the differentiation between the core infarct and the still viable penumbra is its major clinical application. ctp helps directly in the decision-making process in the event of acute ischemic stroke by increasing the potential of success in patient who can benefit from thrombolytic/endovascular treatment. the use of ctp in patient selection for thrombolytic/endovascular treatment was never evaluated in a prospective randomized study. yet, clinical experience well demonstrated a good correlation between the size of the penumbra and the clinical outcome when done in early as well as late stages of the event. the importance of identifying the penumbra in the acute phase of the ischemic stroke is widely accepted. but crucial evidence to support the predictive value of ctp to predict the clinical and anatomical/structural outcomes in the late phases (90 days after) is lacking. currently, the use of ctp is based on theoretical assumptions and expert opinions but a randomized prospective study to validate its use is lacking. the current guidelines restrict the use of ctp trials and to patients that can't performed mri scan.


Eligibility criteria:
inclusion criteria: * nihss\>=8 * up to 6 hours from event onset exclusion criteria: * mrs\>= 3 before the start of the event * life expectency \<1 year because other disability disease
prospective registry on user experience with the mapping system for ablation procedures

Conditions: Cardiac Arrhythmias

Summary: this is an observational, prospective, non-randomized, multicenter, post approval study being conducted in the united states, europe and asia-pacific regions.

the true hd study is aimed at collecting real-world data on the use of the rhythmia mapping system and the intellamap orion mapping catheter in patients indicated for ablation procedure with use of a 3d mapping system. the study will collect specific information on management of ablation procedures with the commercial system including but not limited to acute procedural success, type and proportion of arrhythmias mapped/treated, and how mapping system is used overall. usage data may be used for the planning of future clinical trials.

Eligibility criteria:
inclusion criteria: * subjects who are eligible for an ablation procedure with the rhythmia 3d mapping system and intellamap orion mapping catheter according to current international and local guidelines (and future revisions) and per physician discretion; * subjects who are willing and capable of providing informed consent; * subjects who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center; * subjects whose age is 20 years or above, or of legal age to give informed consent specific to state and national law. exclusion criteria: * subjects requiring de novo ablation of atrial fibrillation; * subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the sponsor to determine eligibility\*; * the subject is unable or not willing to complete follow-up visits and examination for the duration of the study; * subjects who have undergone a previous cardiac ablation within 30 days prior to enrollment; * unrecovered/unresolved adverse events from any previous invasive procedure; * women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion).

Keywords: cardiac arrhythmias cardiovascular disease radiofrequency ablation cardiac mapping
neurodevelopmental disorders in children with congenital heart disease

Conditions: Congenital Heart Disease

Summary: children with congenital heart disease are at risk for neurodevelopmental disorders, these disorders impacting their quality of life and their integration into society. the aim of this study is to detect neurodevelopmental disorders in children (aged from 6 to 66 months) with congenital heart disease in nord-pas-de-calais (france) and to evaluate the frequency and risk factors of these neurodevelopmental disorders for a better follow-up. this study will help implementing a specific program for the evaluation and management of neurodevelopmental disorders in children suffering from congenital heart disease in nord-pas-de-calais and more globally, in the region hauts-de-france.

are selected children with "significant" congenital heart disease (aged from 6 to 66 months) in "nord-pas-de-calais" fulfilling inclusion criteria. a reliable and valid questionnaire used to screen developmental delays of children aged from one month to 66 months is completed by volunteer parents at the time of the study. data of the questionnaire is collected and a scoring by professional is provided ; children at risk for neurodevelopmental delays are depicted. in parallel, medical and surgical history is also collected to detect risk factors for neurodevelopmental disorders. the frequency of neurodevelopmental disorders in this screened population according to risk factors (among neonatal data, severity of congenital heart disease, surgery, length of stay at hospital,... ) will be evaluated. the ratio children with neurodevelopmental disorders for whom specific care was implemented/ children with neurodevelopmental disorders who did not have specific care despite neurodevelopmental disorders will be established. follow-up action will be taken for children at risk for developping neurological disorders highlighted by the screening. this study will help implementing a specific program for evaluation and management of neurodevelopmental disorders for children with congenital heart disease in our region.

Eligibility criteria:
inclusion criteria: * children aged 6 to 66 months at the time of study * living in region "nord-pas-de-calais" * with " significant" congenital heart disease (= complex congenital heart diseases operated or not, simple or moderate congenital heart disease who had cardiac surgery) * followed by the pediatric cardiology department of lille university hospital, or patients having a cardiopediatric follow-up outside lille university hospital but having been taken in charge at the university hospital of lille for any reason (cardiac or not) exclusion criteria: children : * lost to sight * deceased * with congenital heart disease, living in nord-pas-de-calais but never having been taken in charge at lille university hospital * with mild or moderate congenital heart disease not having undergone surgery or having only undergone cardiac catheterization * with cardiac surgery not performed in the centers of jacques cartier and marie lannnelongue

Keywords: neurodevelopmental disorders, congenital heart disease children