Kornimate/medical-research-clean huggingface dataset:
evolution of the endonasal microbiota in patients with chronic rhinosinusitis

Conditions: Chronic Sinusitis

Summary: chronic rhinosinusitis (crs) is defined according to the french society of otorhinolaryngology as chronic non-mechanical damage to the nasal structures, excluding infectious damage to the sinus structures. the duration of the chronic impairment must be at least 12 consecutive weeks. it causes many symptoms such as rhinorrhea, nasal blockage and anosmia. it is a poorly understood pathology that affects a large part of the population. its prevalence has increased significantly over the past 30 years. it affects about 11% of the population in europe. it has become one of ten high-cost medical conditions for employers. initially, it was accepted that crs was due to chronic nasal infection. it is very debilitating for patients leading to a major consultation with practitioners (general practitioners and ent specialists). many treatments are used such as nose washes, nasal or oral corticosteroids, antibiotic therapy or even surgical management is possible. thèses treatments allow an improvement in the symptomatology but no treatment allows a stable result over time, making long-term treatments essential. today, it is recognized that crs has a multifactorial etiology including inflammatory processes, hyperresponsiveness of the nasal mucosa and abnormalities in immune phenomena. the endonasal microbiota plays a role in these processes. germs like staphylococcus aureus and pseudomonas aeruginosa were identified as pathogens in crs in the first studies with bacterial cultures. thanks to the 16s ribosomal rna sequencing technique, recent studies have demonstrated a modification in the diversity and abundance of the microbiota in patients with crs compared to healthy subjects, notably with a modification of the germs of the firmicutes group. . few studies have studied the modification of the microbiota with the treatment of crs today. however, local treatments based on nosewashing with physiological saline associated with local corticosteroids and endoscopic treatments lead to an improvement in the symptomatology for patients suffering from crs. this study will describe the modification of endonasal microbiota in différent conditions, such medical and surgical treatments, that usually improve patients symptomatology.


Eligibility criteria:
inclusion criteria: * patients without chronic rhinosinusitis who undergo a nasal surgery * patients with chronic rhinosinusitis who undergo a medical or surgical treatment exclusion criteria: * minor patients * pregnant or lactating women * patients undergoing antibiotic therapy in the month preceding the start of the study * patients with immunosuppression * ent cancer or other cancer in progress * primary ciliary dyskinesia or cystic fibrosis * systemic vasculitis (wegener, gougerot-sjögren ...) * refusal to participate in the study
discovering treatment reality of type 2 diabetes in real world setting in japan

Conditions: Type 2 Diabetes Mellitus

Summary: this study is intended to prospectively research the treatment reality and long-term disease control of type 2 diabetes mellitus (t2dm) patients who are initiating 2nd line anti-diabetes treatment in sites across japan.

this study is a single country, multicenter, observational, prospective, longitudinal cohort study which will include adult patients with documented history of t2dm who are initiating a second line oral or parenteral anti-diabetes mediation after their first line anti-diabetic therapy in real world setting. the follow-up period is 3 years. patients will undergo clinical assessments and receive standard medical care as determined by the treating physician. patients will not receive experimental intervention or experimental treatment as a consequence of their participation in the study.

Eligibility criteria:
inclusion criteria: 1. written consent obtained 2. aged \> = 20 years 3. diagnosed with type 2 diabetes mellitus 4. initiating a second oral or parenteral anti-diabetic therapy added to oral anti-diabetic monotherapy or switching from the monotherapy to another monotherapy with different drug class exclusion criteria: 1. diagnosis of type 1 diabetes mellitus 2. current pregnancy 3. current treatment for any cancer 4. current dialysis treatment or renal transplantation 5. current treatment with any oral steroids 6. participation in any randomized control trials 7. presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker who does not understand the local language where interpreter are not available, psychiatric disturbances, alcohol or drug abuse).

Keywords: type 2 diabetes mellitus
pharmacodynamic study of the effect of incb013739 on insulin sensitivity in obese, type 2 diabetic subjects

Conditions: Diabetes Mellitus, Type 2; Obesity

Summary: purpose: a 28-day us study in patients with type 2 diabetes mellitus to assess the safety and tolerability as well as the effects of treatment with an investigational drug.


Eligibility criteria:
inclusion criteria: 1. have an established diagnosis of type 2 diabetes as determined by the investigator. 2. females will be postmenopausal for at least 1 year with documented fsh \> 30 iu/l. exclusion criteria: 1. hypertriglyceridemia \> 500 mg/dl at screening. 2. bmi \> 40 kg/m2. 3. receiving thiazolidinediones, insulin, or exenatide within the 3 months prior to screening. 4. history or clinical manifestations of addison's disease, cushing's syndrome, or other disorders involving glucocorticoids or mineralocorticoids. 5. current treatment or treatment within 30 days or five half-lives (whichever is longer) prior to the first dose of study medication with another investigational medication or current enrollment in another investigational protocol.

Keywords: diabetes; type ii diabetes; non-insulin dependent diabetes; obesity
clinical evaluation of the bd onclarity™ hpv assay on the bd viper™ lt system with cervical specimens

Conditions: Uterine Cervical Neoplasms

Summary: the purpose of the study is to compare the results of the becton dickinson (bd) onclarity™ human papilloma virus (hpv) assay on the bd viper™ lt instrument from liquid-based cytology (lbc) media diluted in bd hpv lbc diluent to adjudicated histology results from biopsy and a molecular composite comparator.


Eligibility criteria:
inclusion criteria: * females who are \>21 years of age * females who provide informed consent exclusion criteria: * known pregnant * cervical cytology specimen collected within the last 4 months * prior complete or partial hysterectomy involving removal of cervix * application of chemical compounds to the cervical area 24 hour prior to study entry- acetic acid, iodine, spermicide, douche, or anti-fungal medications * conization, loop electrosurgical excision procedure (leep), cervical laser surgery or cryosurgery on the cervix has been performed in the last twelve months * enrolled in a cervical disease diagnostic trial since 2007.
carelink® network evaluation

Conditions: Heart Failure

Summary: the purpose of the study is to demonstrate the value of the medtronic carelink® network in clinical practice in the country specific healthcare setting.

evaluation's objectives: comparison of remote device check and in-clinic device assessment. to assess patient ease of use of, and satisfaction with, the medtronic carelink® monitor to assess clinician ease of use of, and satisfaction with, the medtronic carelink® monitor and website to assess the clinic specific clinical value of medtronic carelink® network demonstrate time savings for patients demonstrate time savings for physicians to show the increase of efficiency through increased flexibility and per procedure time to demonstrate better handling of unscheduled activities (symptoms, events, etc.)

Eligibility criteria:
inclusion criteria: * patients who have an implanted medtronic icd, crt-d device that is supported by the medtronic carelink® network * patients have to sign the medtronic carelink® "statement of privacy principles" and the "evaluation data protection statement" documents exclusion criteria: * patients with exclusion criteria required by local law * patient is anticipated to demonstrate poor compliance (for example, mental disturbances)

Keywords: carelink remote monitoring cardiac pacemaker, artificial implantable cardioverter-defibrillators
short dental implants (5 mm) versus long dental implants (10 mm)

Conditions: Bone Loss, Alveolar

Summary: the purpose of this study is to evaluate the survival rate of 5 mm short implants compared to longer implants (10 mm) placed in sinus-grafted sites. primary aim: compare bone loss between the two groups secondary aim: compare surgical time and patient-reported outcomes (satisfaction and post-operative pain)

34 patients requiring an implant to replace an upper missing tooth in the premolar or 1st molar area with a bone crest height from 5 to 8 mm will be recruited for this trial. patients will be randomized to either the test (5-mm implant) or control group (10-mm implant) using a computer-generated randomization list . 17 patients will receive a sinus lift procedure, bone graft, and 10 mm implant while the other 17 patients will receive a 5 mm short implant.

Eligibility criteria:
inclusion criteria: * age 20-70 years at enrollment * systemically healthy patients * full-mouth plaque score and full-mouth bleeding score ≤ 30% (measured at four sites per tooth) * in need of one premolar or 1st molar dental implant in the maxillary area * neighboring teeth to the planned implant must have natural root(s) or implant supported restoration. * presence of natural tooth/teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crown/s deemed by the investigator as likely to present an initially stable implant situation * residual bone height under the maxillary sinus between 5 to 7 mm and a width of at least 7 mm, as measured on cone beam computer tomography (cbct) scans. exclusion criteria: * unlikely to be able to comply with study procedures * uncontrolled pathologic processes in the oral cavity * history of head and neck chemotherapy within 5 years prior to surgery * systemic or local disease or condition that could compromise post-operative healing and/or osseointegration * uncontrolled diabetes mellitus hba1c \>8 * taking corticosteroids, iv bisphosphonates, or any other medication that could influence post-operative healing and/or osseointegration * smokes more than 10 cigarettes/day * bruxer * present alcohol and/or drug abuser * pregnant, unsure pregnancy status, or lactating females (self-reported)
abg+/garlace effects on cardiovascular risk factors in subjects with grade i hypertension

Conditions: Hypertension

Summary: the goal of this clinical trial is to evaluate the dose response effect on cardiovascular disease risk factors of a black garlic extract in subjects with grade i hypertension. the main questions it aims to answer are: * if the reduction in blood pressure (systolic and diastolic) is in a dose-response manner * if the changes in lipid profile are in a dose-response manner participants will be randomly assign to a low dose (250 mg/day), high dose (600 mg/day) or placebo of a standardized garlic extract (abg+/garlace) during 12 weeks


Eligibility criteria:
inclusion criteria: * men and women with grade i hypertension (systolic blood pressure between 130 and 139 mmhg; and diastolic blood pressure between 80 to 89 mmhg) without taking any antihypertensive drug exclusion criteria: * acute or chronic kidney disease including dyslipidemia due to nephrotic syndrome.- - * hypothyroidism * having previously suffered a myocardial infarction or stroke * pharmacological treatment with insulin, sulfonylureas, protease inhibitors * chronic gastrointestinal disease * pregnancy or intention to become pregnant during the study period. * breastfeeding * allergy or intolerance to garlic * high alcohol consumption (\>14 units per week) * smokers

Keywords: grade i hypertension
alvimopan for the treatment of constipation due to opioids being taken for persistent non-cancer pain

Conditions: Bowel Dysfunction; Constipation

Summary: adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (obd) will be randomized (1:1:1) to one of 2 alvimopan arms, or to placebo. the primary objective of this phase 3 confirmatory study is to compare alvimopan with placebo for efficacy in the treatment of obd. the primary efficacy endpoint is based on frequency of bowel movements. subjects will be required to: (1) track their bowel movements and other bowel symptoms and (2) attend 6 clinic visits over 4 months.


Eligibility criteria:
inclusion criteria: * consented to participate in this study. * taking opioid therapy for persistent non-cancer pain. * has bowel dysfunction mainly due to opioids. * has bowel dysfunction since starting opioids as defined by infrequent bowel movements and additional bowel-related symptoms. * willing to discontinue laxative therapy (will be provided study-specific standardized laxative if needed). * willing to report daily bowel symptoms. exclusion criteria: * pregnant, lactating, or planning to become pregnant. * not ambulatory. * participated in another trial with an investigational drug in the past 30 days. * taking opioids for the management of drug addiction or cancer-related pain. * severe constipation whereby the subject is at immediate risk of developing serious complications of constipation. * gastrointestinal or pelvic disorders known to affect bowel transit, produce gastrointestinal (gi) obstruction, or contribute to bowel dysfunction. * hiv-infected, has active hepatitis, or has ever been infected with hepatitis c.

Keywords: constipation gastrointestinal opioids pain non-cancer pain opioid-induced bowel dysfunction
a real-world study of ipilimumab treatment after nivolumab treatment in melanoma in japan

Conditions: Melanoma

Summary: this is a medical chart review of ipilimumab treatment after nivolumab treatment in melanoma in japan


Eligibility criteria:
inclusion criteria: * adult patients \> 18 years of age or older * diagnosis of advanced melanoma (unresectable/metastatic), alive or deceased as of date of data collection * treated with ipilimumab between 31-aug-2015 and 31-mar-2017 before or after nivolumab treatment exclusion criteria: * patients enrolled in any clinical trials at any time * overlapping use of nivolumab and ipilimumab
predicting treatment outcomes in refractory constipation through brain connectivity evaluation

Conditions: Constipation - Functional; Refractory Constipation; Fluoxetine; fMRI; Brain Connectivity; Treatment Efficacy; Somatic Symptom; Mental Symptom

Summary: the goal of this observational study is to identify the characteristics of brain functional connectivity in refractory constipation and fluoxetine-sensitive patients. the main questions it aims to answer are: * investigating the alterations in brain functional connectivity in patients with refractory constipation and fluoxetine-sensitive patients * assessing the predictive value of brain functional connectivity regarding the efficacy of fluoxetine and standard protocol treatments for constipation. participants will receive: * standard physiological and psychological assessments of constipation * bold-fmri tests * standard protocol and fluoxetine treatment if there is a comparison group: researchers will compare: refractory group/fluoxetine sensitive group to see the specific brain alterations.


Eligibility criteria:
inclusion criteria: * 18≤ age ≤ 45 years old * right-handed * patients diagnosed as functional constipation according to the rome iv criteria * informed consent of patients exclusion criteria: * complicated with gastrointestinal organic disease or significant functional abnormalities (tuberculosis, polyps, crohn's disease, tumors, congenital megacolon, pelvic floor muscle relaxation, abnormal colonic transit test, etc.) * long-term intense exercise (continuous exercise for more than 8 hours per week, such as marathon runners or triathletes) * no history of chronic pain, no recent major trauma * drug abuse or tobacco dependence (half a pack or more per day) * combined hypothyroidism and parkinson's disease * patients with confirmed mental illness or neurological disorders who take psychotropic drugs, analgesics or hormones * history of abdominal surgery (appendectomy, hysterectomy, or cholecystectomy) * contraindications to functional magnetic resonance imaging (claustrophobia, metal implants) * pregnant or lactating women with constipation after delivery * patients with other benign and malignant tumors and autoimmune diseases * infectious diseases such as hepatitis b, hepatitis c, aids, etc. * heart disease, organ failure and other chronic diseases that require long-term medication or affect the quality of life

Keywords: fmri functional connectivity refractory constipation
registration of children with cml and treatment with imatinib

Conditions: Myeloid Leukemia, Chronic

Summary: newly diagnosed pediatric patients (age \< 19 years) with bcr-abl-positive cml will be treated with imatinib. serial monitoring of treatment response is performed in one month intervals during the first three months of treatment and in three months intervals thereafter. patients with non-response, poor response (either molecular, cytogenetic, or hematologic non-/poor response) or progress of the disease while under imatinib treatment will stop imatinib and undergo stem cell transplantation. all responders to imatinib treatment with an hla matched donor will undergo stem cell transplantation not later than 2 years after diagnosis.

indication: newly diagnosed pediatric patients with bcr-abl-positive cml. design: multicenter, non-randomized, open, prospective clinical trial. objectives: primary: - assessment of antileukemic activity of imatinib in children and adolescents with philadelphia chromosome-positive chronic myeloid leukemia secondary: * assessment of the time-to event-efficacy variables * correlation of the quality of haematological, cytogenetical and molecular remission in children and adolescents with cml on ongoing imatinib therapy with survival * safety of imatinib endpoints: primary: - rate of haematological, cytogenetical and molecular remissions secondary: * time to progression * duration of chronic phase * time to loss of response * overall survival * assessment of treatment-related toxicities in children and adolescents. inclusion criteria: newly diagnosed ph+ or bcr-abl-positive cml- male and female patients aged 0 to 18 years- written informed consent exclusion criteria: * cml without bcr-abl rearrangement detectable by pcr * pretreatment with interferon alpha or any other cytostatic drug with the exception of hydroxyurea or anagrelide (note: anagrelide is not approved in germany for treatment of cml). however, these patients may be registered as observational patients. * any other severe underlying disease beside cml. * age \> 18 years * pregnant or lactating women * subjects unlikely to comply with the requirements of the protocol number of patients to be enrolled: 150 recruitment period: 5 years treatment period: 2 years planned start of study: 2007 planned end of study: 2013

Eligibility criteria:
inclusion criteria: * newly diagnosed ph+ or bcr-abl-positive cml * male and female patients aged 0 to 18 years * written informed consent exclusion criteria: * cml without bcr-abl rearrangement detectable by pcr * pretreatment with interferon alpha or any other cytostatic drug with the exception of hydroxyurea or anagrelide (note: anagrelide is not approved in germany for treatment of cml). however, these patients may be registered as observational patients. * any other severe underlying disease beside cml. * age \> 18 years- pregnant or lactating women * subjects unlikely to comply with the requirements of the protocol

Keywords: cml children imatinib bcr-abl response imatinib mesylate
treatment of covid-19 patients using wharton's jelly-mesenchymal stem cells

Conditions: Use of Stem Cells for COVID-19 Treatment

Summary: the purpose of this study is to investigate the potential use of wharton's jelly mesenchymal stem cells (wj-mscs) for treatment of patient diagnosed with corona virus sars-cov-2 infection, and showing symptoms of covid-19.

covid-19 is a condition caused by infection with coronoa virus (sars-cov-2). this virus has a high transmission rate and is spreading at very high rates. causing a worldwide pandemic. patients diagnosed with covid-19 and confirmed positive with the virus, will be given three iv doses of wj-mscs consisting of 1x10e6/kg. the three doses will be 3 days apart form each other. patients will be followed up for a period of three weeks to assess the severity of the condition and measure the viral titers.

Eligibility criteria:
inclusion criteria: covid-19 positive according to diagnosis and clinical management of covid-19 criteria. exclusion criteria: * participants in other clinical trials * patients with malignant tumors * pregnant and lactating women * co-infection with other infectious viruses or bacteria * history of several allergies * patients with history of pulmonary embolism * any liver or kidney diseases * hiv positive patients * considered by researchers to be not suitable to participate in this clinical trial * chronic heart failure with ejection fraction less than 30%.

Keywords: stem cells, covid-19, sars cov2, wj mscs, immunomodulation,
effect of liraglutide on blood glucose control in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted globally (the united states of america excepted). this trial is designed to show the effect of treatment with liraglutide when added to existing glimepiride therapy and to compare this to both glimepiride monotherapy and to rosiglitazone as add-on therapy to glimepiride.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * treatment with oral anti-diabetic drugs for at least 3 months * hba1c: 7.0-11.0 % (both incl.) in subjects on oad monotherapy. 7.0-10.0 % (both incl.) in subjects on oad combination therapy * body mass index (bmi) less than or equal to 45.0 kg/m2. exclusion criteria: * treatment with insulin within the last three months * treatment with any drug that could interfere with the glucose level * any serious medical condition * females who are pregnant, have the intention of becoming pregnant or are breastfeeding
addressing dementia via agitation-centered evaluation

Conditions: Agitation in Patients With Dementia of the Alzheimer's Type; Alzheimer Disease; Agitation,Psychomotor

Summary: this is a multi-center, randomized, double-blind, placebo-controlled study, to assess the efficacy and safety of axs-05 in the treatment of agitation in patients with alzheimer's disease.


Eligibility criteria:
key inclusion criteria: * diagnosis of probable alzheimer's disease (ad) based on the 2011 national institute on aging-alzheimer association (nia-aa) criteria. * diagnosis of clinically signification agitation resulting from probable ad according to the international psychogeriatric association (ipa) provisional definition of agitation. exclusion criteria: * patient has dementia predominantly of non-alzheimer's type. * unable to comply with study procedures. * medically inappropriate for study participation in the opinion of the investigator.