Kornimate/medical-research-clean huggingface dataset:
a study to investigate the antihypertensive efficacy of mk0954

Conditions: Hypertension

Summary: after a 4 week placebo period, patients were randomized to placebo or losartan 50 mg arms, after 6 weeks non-responders were up titrated to 100 mg losartan for the remaining 6 weeks. this study evaluated if losartan is more effective than placebo in lowering sitting diastolic blood pressure and is well tolerated in patients with mild to moderate hypertension.


Eligibility criteria:
inclusion criteria: * patient has been diagnosed with mild to moderate hypertension (sdbp 95-115 mm hg) * patient has no medical problems or treatments that might effect their blood pressure exclusion criteria: * pregnant or lactating females * patient has secondary hypertension or malignant hypertension * sitting systolic blood pressure \> 210 mm hg * history of stroke * history of myocardial infarction with in past year * current or prior history of heart failure * known hypersensitivity to losartan * prior exposure to losartan * patients known to be hiv positive * patient is abusing or has abused alcohol or other drugs within the past 4 years
association between her2 status and pcr rate in er-positive breast cancer receiving neoadjuvant endocrine or chemotherapy

Conditions: Breast Neoplasms

Summary: in estrogen receptor (er)-positive breast cancer (bc), human epidermal growth factor receptor-2 (her2)-low ones are reported to have distinct clinical and molecular features from those with her2-zero or her2-positive status. however, the association between her2-low status with response to endocrine therapy is largely unknown. in this study, we included 518 er-positive bc patients who received either neoadjuvant endocrine therapy (net) or neoadjuvant chemotherapy (nct). the pathologic complete response rate (pcr) of her2-low and her2-zero tumors re-sponding to neoadjuvant therapies were compared. the difference in disease-free survival (dfs) and overall survival (os) between the two groups was also analyzed. the pcr (defined as ypt0/isnx) in her2-low bcs and in her2-zero bcs for net cohort and nct cohort were compared.


Eligibility criteria:
inclusion criteria: patients diagnosed with invasive breast cancer and who received surgery from 2015 to 2021 exclusion criteria: none
effect of mat pilates training on blood pressure of hypertensive individuals

Conditions: Hypertension

Summary: the study aimed to evaluate the chronic effects of mat pilates training on blood pressure, heart rate, double product and psychobiological factors in hypertensive medicated women and acute effects of mat pilates exercise on blood pressure of such individuals.


Eligibility criteria:
inclusion criteria: * hypertensives women * age 30 to 59 years * nonactive * make use of antihypertensive medication exclusion criteria: * orthopedic problems or other problem that prevented the exercises * change in drug treatment during protocol * absence in more than 25% of the exercise sessions
lung heart rate variability

Conditions: Non Small Cell Lung Cancer

Summary: the purpose of this study is to examine the effects of heart-rate variability biofeedback training on lung cancer patients receiving definitive radiation therapy. the target population consists of non-small cell lung cancer (nsclc) patients receiving 6 weeks of radiation therapy. the study will utilize the physiolab gp8 heart rate variability and respiration system to collect data as well as several survey instruments to analyze quality of life measures. the goal is to show the hrv training can improve certain qol measures like anxiety and sleep quality.


Eligibility criteria:
inclusion criteria: * participants must be older than 18 years of age * both women and men of all ethnic background are eligible to participate in the study. * must be diagnosed with non-small cell lung cancer and receiving 6 weeks of radiation therapy. * must be available and willing to participate in 4, approximately 1 hour hrv biofeedback treatment sessions. * signed informed consent exclusion criteria: * participant is younger than 18 or older than 70 * diagnosed with early stage nsclc * patients who are pregnant * patients with cardiac arrhythmias * patients with pacemakers * patients taking beta-blockers * patients with any major mental illness, cognitive impairment * incapable of giving informed consent
efficacy and safety of lima association in the control of type ii diabetes mellitus.

Conditions: Type2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the efficacy and safety of lima association in the control of type 2 diabetes mellitus


Eligibility criteria:
inclusion criteria: * participants of both sexes, aged 18 years or more; * participants presenting the diagnosis of type ii diabetes mellitus, which have already received previous dietary and physical exercise guidance, who are not receiving any antidiabetic treatment, defined as never taking any antidiabetic medication, or in antidiabetic therapy after being subjected to a washout period; * treatment-naive participants with hba1c between 7.5% and 10.5% and pretreated patients with hba1c between 7,5% and 9,5% at the screening visit; * patients with hba1c between 7.5% and 10.5% at the randomization visit; * participants with bmi (body mass index) \> 19 kg/m2 and ≤ 45 kg/m2. * signed consent. exclusion criteria: * any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants; * history of alcohol abuse or illicit drug use; * participation in clinical trial in the year prior to this study. * fasting glycemia above 300 mg/dl; * risk factors for severe volume depletion; * diuretic use less than 60 days, except for spironolactone; * history of diabetic ketoacidosis; * medical history of acute coronary syndrome, stroke or transient ischemic attack within 3 months prior to informed consent; * impaired hepatic function; * impaired renal function and end stage renal disease; * bariatric surgery in the last two years and/ or other gastrointestinal surgeries; * current medical history of cancer and/ or cancer treatment in the last 5 years; * medical history of blood dyscrasia or any other hemolytic disorders; * medical history of pancreatitis and chronic pancreatitis; * treatment with anti-obesity drugs for less than 2 months or with dose change in the last 2 months; * current and prolonged treatment for more than 15 days with systemic steroids at the moment of informed consent; * any other uncontrolled endocrine disorder, except type 2 diabetes mellitus; * history hypersensitivity to the active ingredients used in the study; * pregnancy or risk of pregnancy and lactating patients; * systemic disease that is not controlled and can put the participant at risk;
the establishment of korean hepatitis b patients cohort

Conditions: Chronic Hepatitis B

Summary: according to the world health organization about 1,400,000 deaths reported annually, are related to chronic liver disease. chronic liver disease is very prevalent in south korea, placing a large economic burden nationwide. subsequently, an effective and systematized approach to managing chronic hepatitis is imperative in korea. the natural history of chronic liver disease differs greatly according to race and ethnicity. however, there is scarcity of epidemic data on chronic hepatitis based on korean patients. therefore, the investigators plan to establish a prospective multicenter cohort for chronic hepatitis b based on korean patients that may be utilized for various future clinical studies on chronic hepatitis b in korea, and thereby serve as a basis for the establishment and distribution of clinical guidelines for korean patients with chronic hepatitis b, as part of a nationwide project supported by the centers for disease control (cdc), korea. the investigators plan to collect more than 2,000 cases per year with 6 months of regular follow-up interval as have been advised by the cdc during 10 years of the study period (from sep. 2015) from 5 tertiary hospitals located in korea. the investigators plan to register available cases from those who are available to agree to give written informed consent and provide their blood samples to participate in this study prospectively, according to the inclusion and exclusion criteria.


Eligibility criteria:
inclusion criteria: 1. age above 19 years; 2. chb diagnosis with more than 6 months of hbsag positive; 3. patients who followed up regularly by medical institutions due to chb; 4. patients who can be followed up according to the research protocol; 5. patients who have consented to the written consent of the applicant or guardian. exclusion criteria: 1. hcc diagnosis before enrollment; 2. malignant tumor other than hcc within 5 years; 3. hepatitis c virus or human immunodeficiency virus co-infection; 4. fatal conditions such as decompensated liver function, end stage renal disease and severe heart failure; 5. not be suitable for the research purpose.

Keywords: chronic hepatitis b cohort nationwide prospective antiviral therapy
efficacy and safety of nm-702 tablets for the treatment of intermittent claudication

Conditions: Intermittent Claudication; Peripheral Vascular Disease

Summary: nm-702 oral tablets are being developed for the treatment of intermittent claudication, a primary early stage indication of peripheral arterial disease (pad). this trial is designed to assess the safety and efficacy of 4 mg and/or 8 mg nm-702 taken twice a day (bid) for 24 weeks to see if it improves peak walking time (pwt) more than placebo for the treatment of intermittent claudication.

nm-702 oral tablets are being developed for the treatment of intermittent claudication, a primary early stage indication of peripheral arterial disease (pad). this trial is designed to assess the safety and efficacy of 4 mg and/or 8 mg nm-702 bid for 24 weeks to see if it improves peak walking time (pwt) more than placebo for the treatment of intermittent claudication.

Eligibility criteria:
inclusion criteria: * stable, symptomatic, intermittent claudication due to occlusive atherosclerotic disease of the lower extremities * median treadmill peak walking time between 90 and 600 seconds exclusion criteria: * symptoms of limb threatening ischemia (ischemic rest pain, ischemic ulceration and/or gangrene) * clinically significant pulmonary, neurological or skeletal dysfunction (e.g., lumbar canal stenosis, emphysema, uncontrolled angina, multiple sclerosis, or gait altering amputation) that would directly interfere or limit exercise testing * subjects who have had, or will require, a peripheral revascularization procedure within 12 weeks prior to or following treatment initiation. * a resting blood pressure greater than 150/100 and other clinically significant results.

Keywords: nm-702 tablets intermittent claudication peripheral arterial vascular peripheral arterial disease
a case control study of the effectiveness of q/laiv versus inactivated influenza vaccine and no vaccine in subjects 2-17 years of age

Conditions: Influenza Vaccine Effectiveness

Summary: this is a post-marketing case-controlled study of the effectiveness of a quadrivalent live attenuated influenza vaccine (q/laiv/flumist® quadrivalent) versus inactivated influenza vaccine (iiv) and no vaccine in subjects 2-17 years of age.

this post-marketing study will enroll approximately 5,200 subjects 2-17 years of age who are seeking care in an outpatient setting for febrile acute respiratory illness. this study will begin in the fall of 2013 and will be completed after 4 influenza seasons (i.e.after the 2016-2017 influenza season). no investigational product will be administered in this study. a nasal swab will be obtained and tested for the presence of influenza virus and other viral pathogens. this study will be conducted at 4 sites in the united states of america. the duration of study participation for each subject is one day.

Eligibility criteria:
inclusion criteria: * community-dwelling children and adolescents 2 to 17 years of age. * written informed consent or assent. * acute respiratory illness documented at study visit or at home with fever (oral temperature ≥ 100.0° fahrenheit at study visit, or history of fever reported by parents, or use of antipyretic prior to study visit) * symptom onset less than 5 days prior to study visit. * subject and/or subject's legal representative is able to understand and comply with the requirements of the protocol as judged by the investigator. exclusion criteria: * treatment with an antiviral drug for influenza (oseltamivir or tamiflu®, zanamivir or relenza®) during the 14 days before enrollment * any condition that, in the opinion of the investigator, would interfere with interpretation of subject safety or study results * concurrent enrollment in another clinical study patient already enrolled during this influenza season * employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals.

Keywords: q/laiv/flumist® quadrivalent vaccine inactivated influenza vaccine (iiv) effectiveness influenza
impact of a alveolar ridge preservation technique on the need of performing guided bone regeneration for dental implant placement

Conditions: Tooth Avulsion

Summary: the aim of this study is to investigate how a socket preservation procedure may reduce the need of guided bone regeneration surgery after tooth extraction and facilitate the placement of a dental implant in the optimal, prosthetic-driven position.

the main gol of the study is to assess the efficacy of a socket preservation procedure in reducing the need of additional surgeries in order to augment alveolar bone volume before placing a dental implant in optimal position. bone volume at 6 months will be compared to initial volume in order to assess volume variations and how they affect the positioning of a prosthetically driven, implant.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * at least one intercalate tooth to be extracted, with complete alveolus and no soft tissue recession; * adequate oral hygiene, i.e. plaque index score ≤10%; * mesial-distal width of inter-dental space ≥7 mm; exclusion criteria: * american society of anesthesiologists (asa) score ≥iii * presence of active periodontitis, clinically diagnosed in presence of probing depths ≥4 mm and bleeding on probing * a history of radiotherapy to the head and neck region * presence of conditions requiring chronic use of antibiotics * medical conditions requiring prolonged use of steroids * history of leucocyte dysfunction * history of bleeding disorders * history of renal failure * patients with metabolic bone disorders * patients with uncontrolled endocrine disorders * disability affecting oral hygiene * alcohol or drug abuse * hiv infection * smoking \>10 cigarettes a day or cigar equivalents * conditions or circumstances that would prevent completion of study participation * mucosal diseases * presence of osseous lesions * severe bruxing or clenching habits * persistent intraoral infections * compromised alveolus (dehiscence, etc)

Keywords: socket preservation single implant tooth extraction
efficacy of activated recombinant human factor vii in healthy volunteers treated for punch biopsy mediated bleeding

Conditions: Haemostasis; Healthy

Summary: this trial is conducted in the united states of the america (usa). the aim of this trial is to evaluate the effectiveness of activated recombinant human factor vii to mitigate experimentally-induced bleeding in healthy volunteers treated with clopidogrel (plavix®).


Eligibility criteria:
inclusion criteria: * pt/ptt within normal laboratory range (e.g., pt: 9.4-12.0) * platelet count within normal laboratory range exclusion criteria: * the receipt of any investigational drug within 1 month prior to this trial * use of anticoagulation therapy-defined as vitamin k antagonists, platelet antagonists, heparin * (or low molecular weight heparin), aspirin or nsaids (non-steroidal anti-inflammatory drug) within 30 days prior to trial * african-american race * weight above or equal to 160 kg
safety and efficacy of oral colostrum derived anti influenza antibodies in healthy volunteers

Conditions: Influenza

Summary: administration of colostrum enriched with anti-flu antibodies may alter host's response to the flu virus.


Eligibility criteria:
inclusion criteria: * healthy male volunteers ages 18-60 * if participating in sexual activity that could lead to pregnancy, the study volunteer must agree that two reliable methods of contraception will be used simultaneously while receiving the protocol-specified medication and for 1 month after stopping the medication * men \> 18 years. * ability and willingness of subject to provide informed consent * screening tests' results within 15% of normal values exclusion criteria: * female * continuous use of the following medications for more than 3 days within 30 days of study entry: * immunosuppressives * immune modulators * systemic glucocorticoids * anti-neoplastic agents * active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. * serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry. * subjects with a clinically significant infectious, immune mediated or malignant disease * subjects with anemia (hb \<10.5 gm/dl) * subjects with thrombocytopenia (platelets \<100k/µl) * subjects with lymphopenia (absolute lymphocyte count \<0.7) * subjects who were previously vaccinated against flu. * subject who received any vaccination within the last 6 months

Keywords: modulating immune response to flu antigen
optimization of hearing performance in the subject implanted

Conditions: Hearing Loss

Summary: in the past two decades, the selection criteria for cochlear implantation have been greatly relaxed so that about 60-70% of present cochlear implant (ci) candidates have significant residual hearing in their contralateral ear. however, contralateral hearing is often not considered in rehabilitation programs, mainly due to the lack of scientific evidence on the role it may play. the present project aims to better understand the mechanisms of perceptual learning of ci-processed speech after implantation and to develop and test rehabilitation strategies for ci users.


Eligibility criteria:
inclusion criteria: * age\>18 * unilaterally postlingually-deafened adult cochlear implanted candidates (ic-uni) * person with almost normal or moderate contralateral hearing ( under 60db) * cochlear implanted person whose activation has not yet been performed * cochlear implanted subjects with bilateral post-lingual profound deafness, who already benefit from a unilateral cochlear implant and candidates to a bilateral cochlear implant * affiliated to social security exclusion criteria: * - subjects under juridical protections or tutelage measure * subjects with associated neurological or neurodegenerative conditions * significant anatomical changes on ct scan of the temporal bone that may interfere with the insertion of the cochlear implant

Keywords: deafness, cochlear implant
how long must the mri follow-up last to safely identify middle ear residual cholesteatoma

Conditions: Middle Ear Cholesteatoma

Summary: previous studies demonstrated the high diagnostic value of non-echoplanar diffusion weighted magnetic resonance imaging (non-ep dwi) for residual cholesteatoma. however, limited data are available regarding a suitable length of imaging follow-up. the present study aimed to determine the optimal duration of non-ep dwi follow-up for residual cholesteatoma

a retrospective, monocentric study was performed between 2013 and 2019 and included all patients regularly followed-up after canal wall-up tympanoplasty with at least two non-ep dwi performed on the same 1.5t mri scanner. mr images were reviewed independently by two radiologists. sensitivity and specificity values were calculated as a function of time after the surgery. receiver operating characteristics (roc) curves were analyzed to determine the optimal follow-up duration.

Eligibility criteria:
inclusion criteria: - patients regularly followed-up for middle ear cholesteatoma, who underwent two or more non-ep dwi performed on the same 1.5 tesla mri scanner exclusion criteria: - congenital cholesteatomas, tympanoplasty with canal wall-down technique, or suspicion of residual cholesteatoma on the first mri follow-up

Keywords: residual cholesteatoma imaging follow-up canal wall-up tympanoplasty non-ep dwi
resound: rebif satisfaction on discontinuing oral dimethyl fumarate

Conditions: Multiple Sclerosis

Summary: this is a phase iv, prospective, open-label, multi-center trial to assess the treatment satisfaction in patients with relapsing forms of multiple sclerosis (ms) who are currently being treated with, but are considering discontinuing treatment with tecfidera™.


Eligibility criteria:
key inclusion criteria: * diagnosis of relapsing form of ms * have declared a desire/plan to discontinue treatment with tecfidera due to tolerability issues and/or lack of efficacy * expanded disability status scale (edss) score 0 to 5.0 inclusive * other protocol defined inclusion criteria could apply key exclusion criteria: * pregnant or lactating * significant renal or hepatic impairment or other significant disease that would compromise adherence and completion of the trial * other protocol defined exclusion criteria could apply

Keywords: multiple sclerosis rebif ® tecfidera ™ treatment change
patient empowerment with the patient perspective

Conditions: Colorectal Cancer

Summary: the overall aim with this study is to gain a deeper understanding of patient perceptions regarding empowerment in relation to a health platform.

this is a two-stage study design. the first stage consists of focus groups interviews. three focus groups with 6-8 patients (colorectal cancer patients diagnosed at least one year ago) in each group, will be invited. the focus group interviews will be moderated by one researcher, but accompanied with a second observing researcher. the participants will be identified using the regional swedish colorectal cancer registry in västra götaland. the participants will be contacted by a short letter (appendix) indicating that we will call them with more information. the participants will by phone be asked to participate in the study and then invited to the focus groups. the second phase of the project includes a questionnaire, which will be sent to 200 patients from the same population. the questionnaires will be delivered by using the sunet survey system, which is a system approved by university of gothenburg. if the participants prefers a paper copy, or lack the possibility to reply online, a paper copy will be send via mail instead. at this moment the investigators have developed a questionnaire, which may be refined due to the understating achieved from the focus group interviews.

Eligibility criteria:
inclusion criteria: * patient with colorectal cancer exclusion criteria: * inability to give informed consent or speaking and reading the swedish language.