Kornimate/medical-research-clean huggingface dataset:
a drug-drug interaction (ddi) study of hdm1002 with repaglinide, atorvastatin, digoxin and rosuvastatin in healthy subjects and overweight subjects.

Conditions: Healthy Adult Subject; Overweight Subject

Summary: the purpose of this study is to characterize the effect of hdm1002 on the pk of single dose of repaglinide, atorvastatin, digoxin and rosuvastatin in healthy adult subjects. the safety and tolerability of hdm1002 with repaglinide, atorvastatin, digoxin and rosuvastatin when given separately or together will also be evaluated.


Eligibility criteria:
inclusion criteria: 1. according to the medical history, clinical laboratory test results, vital sign measurements, 12 lead ecg results, and physical examination results during the screening period, the investigator considers the subject to be in good general health. 2. age range of 18-45 years old (including range), no limit to gender. 3. male subject weighed ≥50.0 kg, female subject weighed ≥45.0 kg, and a body mass index (bmi) within the range of 19.0 - 30.0 kg/m2 (including cut-off values). exclusion criteria: 1. subject has a history or family history of medullary thyroid cancer, thyroid c-cell hyperplasia, or multiple endocrine neoplasia type 2 (men2), or calcitonin≥50 ng/l during the screening period. 2. history of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening. 3. history of acute cholecystitis attack within 3 months prior to screening. 4. subject judged by investigator has dysphagia, diseases or conditions that affect gastric emptying, or affect the absorption of gastrointestinal nutrients, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, etc. 5. history of previous surgery that will affect the absorption, distribution, metabolism, and excretion of drugs or plan to undergo surgery during the study period. 6. during screening period, any abnormalities in physical examination, electrocardiogram, laboratory tests, and vital signs which are of clinically significant . 7. taken or planned to take any drug that effect liver enzyme or transporter activity within 28 days prior to taking the investigational drug. 8. history of clinically significant cardiovascular and cerebrovascular disease within 6 months prior to screening or at the time of admission. 9. presence of clinically significant ecg results judged by the investigator at screening.

Keywords: hdm1002 glucagon-like peptide-1 receptor agonists
computerized facial recognition for automated diagnosis of the facio-scapulo-humeral muscular dystrophy (fsmhd)

Conditions: Facio-Scapulo-Humeral Dystrophy

Summary: the clinical diagnosis of facio-scapulo-humeral muscular dystrophy (fshmd) requires the movement of patients to a medical centre and a lengthy examination involving medical personnel, and may be underestimated in the most moderate cases. thus, it requires costly and burdensome logistics both for patients living in remote areas and having to undertake long and expensive travel, and for clinical staff. this is an obstacle to large-scale diagnosis. the investigators plan to alleviate these limitations through the use of digital facial analysis technology that would enable large-scale diagnosis of patients through telemedicine. motivated by the reasons described above and by preliminary results, the goal of this project is to develop methods to automatically detect and monitor the progression of this disease using computer vision algorithms. in order to do this, the investigators will first build up a bank of images and videos of patients with moderate to severe fshmd, patients with other muscular dystrophies causing facial muscle asymmetry, as well as control subjects without facial involvement. each of these subjects will be characterized clinically and genetically. the investigators will then develop computer tools using video and audio sensors capable of detecting facial muscle damage in patients with fshmd and differentiating them from control subjects on the one hand and patients with other muscular dystrophies on the other hand. the investigators wish to use the most recent advances in terms of "deep-learning" and improve their architecture in order to achieve our objectives. in addition to this holistic approach, the investigators will study facial recognition approaches capable of accurately identifying different facial areas on images, as well as the relevance of different statistical properties of facial dynamics (duration and intensity). these algorithms will also be useful for monitoring the evolution of facial damage in order to develop a specific measurement tool that could be used in patient follow-up and in clinical trials on early stages of the disease.


Eligibility criteria:
- patient belonging to one of these four groups: * group 1 fsmhd confirmed or to be confirmed with moderate facial involvement * group 2 fsmhd confirmed or to be confirmed with severe facial involvement. * group 3 other disease nm confirmed or to be confirmed. * group 4 control subjects. exclusion criteria: * patient presenting all pathologies judged by the investigator to interfere with the smooth running of the study (facial trauma, ...). * pregnant or breastfeeding women of childbearing age.
ultrasound guided rhomboid intercostal and subserratus plane block in breast cancer surgeries

Conditions: Breast Cancer Surgery; Postoperative Analgesia

Summary: postoperative analgesia after breast cancer surgery is a challenge for anesthesiologists due to the complex innervation of the breast. interfascial plane blocks of the chest are gaining widespread popularity with the introduction of ultrasonography into the regional anesthesia practice. we aimed to investigate the efficacy of rhomboid intercostal and subserratus plane block (riss) for postoperative analgesia in patients undergoing breast cancer surgery.

this prospective randomized controlled trial will be carried out on female patients who scheduled for breast cancer surgery. our hypotesis is that this new interfascial plane block technique will able to provide postoperative analgesia in breast cancer surgery.

Eligibility criteria:
inclusion criteria: * female patients aged 18-85 years and asa physiological score i-iii who undergone breast cancer surgery exclusion criteria: * patients refused to participate. * patients with known or suspected allergy to the used medication. * patients with psychiatric-neurological disorders that may affect pain perception, * patients regularly taking antipsychotics and antidepressants. * patients with potential risk of coagulopathy. * uncooperative patients.

Keywords: rhomboid intercostal and subserratus plane block
continuos subcutaneous insulin infusion in italy

Conditions: Type 1 Diabetes

Summary: this is an observational, multicenter, cross sectional study, collecting clinical and metabolic informations about patients treated with csii in italy.

the aim of the study is to collect clinical and metabolic characteristics of patient treated with csii in italy. data will be collected through a questionnaire sent by e-mail to csii experienced diabetes centers ( both adult and pediatric patients) . the questionnaire assessed: (1) number of csii-treated patients; (2) patients and pump characteristics; (3) structure and organization of diabetes centers providing csii therapy; (4) metabolic control.

Eligibility criteria:
inclusion criteria: * all patients treated with csiiin italy exclusion criteria: * none

Keywords: type 1 diabetes csii
a prospective, observational study of clinician and patient-reported outcomes in patients with dermatological conditions

Conditions: Atopic Dermatitis; Dermatology; Vitiligo; Alopecia Areata; Hidradenitis Suppurativa; Psoriasis

Summary: the primary goal of the study is to collect standardized patient and clinician reported outcome measures for patients diagnosed with a range of dermatological conditions in an academic clinical practice setting. by regularly measuring outcomes longitudinally in patients treated in a real-world setting, this study will provide valuable and necessary information as to the impact of both the disease and its treatments on patients over time and will inform the optimal clinical management of patients with living with dermatological disease.

the study is a multi-center, longitudinal, observational study to describe longitudinal trajectories of clinician-reported outcomes (clinros) and patient-reported outcomes (pros) in patients with select dermatological conditions. this study will collect data using validated clinical instruments and patient-reported data on the disease course of alopecia areata (aa), atopic dermatitis (ad), hidradenitis suppurativa (hs), psoriasis (pso), and vitiligo (vl), including symptom assessments and quality of life (qol) measures from a patient perspective, to supplement routine clinical data collected from their healthcare providers. clinro data will be collected at baseline and routine follow-up visits for up to two years. pro data will be collected directly from patients at baseline and at pre-specified follow-up time points (as defined in tables 1 - 2e) for up to two years. the objectives of this study are: * to describe longitudinal changes in disease activity, symptom control and both physical and mental hrqol based on both clinros and pros * to identify patient, disease and treatment factors associated with changes in pros over time * to describe the association between pros, clinros and clinical outcomes

Eligibility criteria:
inclusion criteria: * adult (defined as the age of majority in their state of residence or older) at enrollment * able to read and communicate in english * have a smart phone or other internet enabled device capable of pro data collection * diagnosed with a qualifying, clinically confirmed, diagnosis of a study condition in the judgement of the treating physician at presentation * willing and able to provide informed consent * willing to participate in the collection of patient-reported outcomes for up to two years exclusion criteria: * current (or planned) participation in an interventional clinical trial where treatment and/or management of any of the study conditions is being dictated by a protocol. * patient is not expected to be actively followed (i.e., seen at least annually as part of routine care) at the site for the duration of the follow-up period.

Keywords: registry patient outcomes dermatological conditions
upregulation of alpha-1 receptors upon septic shock?

Conditions: Septic Shock

Summary: the hallmarks of septic shock are hypovolemia and reduced pressor response to endogenous noradrenaline. the working hypothesis is that the higher the plasma concentration of endogenous noradrenaline will be, the lower the pressor response to exogenous noradrenaline will be. this will be tested in patients presenting with septic shock, following state of the art management (including repeated assessment of vena cava diameter and compliance, and response to dynamic indices of loading) following placebo vs clonidine administration (1 mcg.kg-1.h-1 over 24 h without bolus) and administration of increasing doses of noradrenaline (1 mcg, 2 mcg, etc. up to a delta systolic blood pressure circa 25-30 mm hg).


Eligibility criteria:
inclusion criteria: * patients presenting to the ccu with septic shock : sbp\ 30 ml.kg-1 within 6 h before inclusion) thus in need administration of noradrenaline for \>1 h (0.1 mcg.kg-1.h-1 i.e. \>0.5 mg.h-1/70 kg) to maintain mean bp\>65 mm hg. * criteria for sepsis :temperature\>38.5 or \ 12 000 or \ 20 cycles par min) or mechanical ventilation ; tachycardia : \>90 bpmin * written informed consent by the patient or next of kin or signature by the investigators of the form "emergency inclusion" exclusion criteria: * age\<18 ans * pregnancy * mental illness making informed consent impossible * absence of consent as signed by the patient or next of kin or signature of "emergency inclusion form" * individual without social security coverage or participating in another biomedical research * contre-indications to clonidine (uncorrected hypovolemia, sick sinus syndrom, iii grade av block) * hr\<70 bp/min * pre-exitus

Keywords: pressor response chronotropic response
cumulative live birth rate with eset after preimplantation genetic screening versus conventional in-vitro fertilization

Conditions: Infertility

Summary: the purpose of this randomized clinical trial is to compare the efficacy and safety with transfer of embryos selected by next generation sequencing (ngs) versus conventional morphological criteria. subjects with 3 or more blastocysts on day 5 of embryo culture will be randomized to the pgs or ivf group. a freeze-all strategy and a single frozen blastocyst transfer will be performed in both pgs and ivf groups. the primary outcome is the cumulative live birth after transfers of up to 3 single blastocycsts in both groups.

this is a multicenter, randomized clinical trial comparing the efficacy and safety with transfer of embryos selected by next generation sequence (ngs) and morphologic criteria versus by morphological criteria alone. subjects who obtain 3 or more good-quality blastocysts will be randomized to pgs or ivf group. all embryos will be frozen and a single thawed blastocyst will be transferred in both pgs and ivf group. subjects in the pgs group will have 3 blastocysts sequenced and euploid embryos will be subsequently transferred. subjects in the ivf group will have blastocysts selected by morphology assessment. the cumulative live birth rate will be counted after transfers of all euploid embryo in the pgs group and 3 blastocysts in the ivf group within 1 year after randomization.

Eligibility criteria:
inclusion criteria: 1. women who are participating in their first cycle of ivf or icsi 2. women ages 20 to 37 years. 3. women who obtain 3 or more good-quality blastocysts defined as morphological score of inner cell mass b or a, trophectoderm c or better, and grade 4 or better on day 5 of embryo culture will be randomized. exclusion criteria: 1. women with a uterine cavity abnormality, such as a uterine congenital malformation (uterus uni-cornate, bicornate, or duplex); untreated uterine septum, adenomyosis, submucous myoma, or endo-metrial polyp(s); or with history of intrauterine adhesions. 2. women with untreated hydrosalpinx; 3. women who are indicated and planned to undergo pgd, for example, parental abnormal karyo-type or diagnosed with monogenic disease; 4. women who use donated oocytes or sperm to achieve pregnancy; 5. women with contraindication for assisted reproductive technology or for pregnancy, such as poorly controlled type i or type ii diabetes; undiagnosed liver disease or dysfunction (based on se-rum liver enzyme testing); renal disease or abnormal serum renal function; significant anemia; history of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident; uncontrolled hyper-tension, known symptomatic heart disease; history of or suspected cervical carcinoma, endometrial carcinoma, or breast carcinoma; undiagnosed vaginal bleeding.

Keywords: preimplantation genetic screening single embryo transfer frozen embryo transfer cumulative live birth rate
evaluation of a new catheter coating process for urinary catheters used for intermittent catheterization.

Conditions: Intermittent Urethral Catheterization

Summary: this is a prospective, double-blinded, randomized, multi-centre, cross-over study. all subjects will use both the study device (test catheter) and the comparator (control catheter) for one week each.


Eligibility criteria:
inclusion criteria: * provision of informed consent. * males, aged 18 years and over. * maintained urethra sensibility as judged by the subject. (can you feel the catheter during catheterization? yes.). * practice cic at least 2 times daily. * using catheters in the size ch 12 or ch 14, nelaton tip, and able to use catheter length of 40 cm. * experienced users of cic defined as a minimum of three months on therapy. * adults able to read, write and understand information given to them regarding the study. exclusion criteria: * ongoing, symptomatic uti at enrolment as judged by investigator. the definition of uti, is a positive urine culture of ≥103 cfu/ml of ≥1 bacterial species and presence of symptoms or signs compatible with uti with no other identified source of infection. * known urethral stricture which, in the opinion of the investigator, could influence the subject's evaluation of the catheters. * involvement in the planning and conduct of the study (applies to both whc staff and staff at the study site). * previous enrolment or randomisation of treatment in the present study. * simultaneous participation in another clinical study that may impact the primary endpoint. * severe non-compliance to protocol as judged by the investigator
stretching and strengthening exercise in fibromyalgia patients

Conditions: Fibromyalgia Syndrome

Summary: fibromyalgia is a rheumatologic syndrome characterized by widespread chronic pain, tender points and other symptoms as fatigue, sleep disturbances, anxiety and depression. therapeutic exercises are described as an important form to management of symptoms. this study aims to assess strengthening and stretching exercise efficacy in symptoms and quality of life of fibromyalgia patients. the study is done at general clinical hospital of medicine scholl of university of sao paulo. 63 subjects undergo the study and they are divided into three groups: 1 strengthening exercise, 2 stretching exercise and 3 control group. patients are evaluated by following instruments: fibromyalgia impact questionnaire, medical outcomes study 36-item short-form health survey (sf-36), stanford health assessment questionnaire, dolorimetry at tender points by a fischer dolorimeter, finger-to-tip floor test for muscular flexibility, dynamometer emg system do brasil for strength test of extension and flexion of knees and elbows, time to get up and go test, functional reach test, sit-to-stand test. subjects of 1 strengthening exercise group undergo a global strengthening program and 2 stretching exercise group undergo a global stretching program. all programs have 12 weeks of duration and physical therapy is twice a week. the control group does not do any intervention during 12 weeks and after the second evaluation they enter the common program of physical therapy. data are being analyzed by descriptive and interferential statistics procedures.

in this study, were included subjects with fibromyalgia diagnosis aged between 30 and 55 years old. we aimed to assess the effect of a physical therapy program on impact of fibromyalgia syndrome and quality of life.

Eligibility criteria:
inclusion criteria: * fibromyalgia diagnosis according to american rheumatology criteria * aged between 30 and 55 years old exclusion criteria: * severe rheumatologic syndromes * neurologic syndromes

Keywords: fibromyalgia, exercise, strength, stretch
piloting a mobile game for behavioral therapy

Conditions: Autism Spectrum Disorder; Autism

Summary: the following study aims to understand the feasibility of the mobile app and game, guesswhat, to deliver behavioral therapy to children with autism. the guesswhat app is a charades style game that engages parent and child in fluid social interaction where the parent must guess what the child is acting out based on the prompt shown on the phone screen. participants will use their own personal phone to download the study app. the app will walk participants through a variety of charades style games. the interactive games will be video recorded and all data are transferred securely to the wall lab for analysis. this study is enrolling parents of children with asd who are at least 18 years of age and have a child between 3-12 years old. parents are asked to complete questionnaires before and after playing the guesswhat game with their child 3-4 times per week for 4 weeks.


Eligibility criteria:
inclusion criteria: * parent who is at least 18 years old of child with autism. * child with autism is between 3 and 12 years old at time of baseline data collection. exclusion criteria: * parent is not able to read or speak english * parent does not have an android or ios smartphone compatible with guesswhat app

Keywords: digital mobile health game autism technology therapy
lipid infusions to optimize nutrition trial

Conditions: Bronchopulmonary Dysplasia; Neurodevelopmental Impairment

Summary: the purpose of this study is to identify survival free of bronchopulmonary dysplasia (bpd), fatty acid profiles, and early biochemical measures for oxidative stress comparing mixed oil lipid emulsion (mole) vs soybean oil-based lipid emulsion (sole) and to establish whether mole or sole is more effective in minimizing pulmonary outcomes, neonatal morbidities, long-term morbidity and mortality, and improving discharge growth and bayley scales of infant development fourth edition (bsid-iv) neurodevelopmental assessment at two years


Eligibility criteria:
inclusion criteria: * inborn \<28 weeks gestational age (ga) or ≤1000g birth weight (bw) * survives until 12 hours after birth. exclusion criteria: * infants who are unable to be enrolled by 96 hours postnatal age * major anomaly * overt non-bacterial infection * infants likely to expire soon defined as limiting or withdrawal of intensive care recommended or requested by the parents.

Keywords: soybean oil-based lipid emulsion (sole) mixed oil lipid emulsion (mole)
identification of integrin ab expression in lung cancer patients

Conditions: Expression of Integrin ανβ3 in Lung Cancer

Summary: it has been reported that the expression rates of integrin αvβ3 and integrin αvβ5 in nsclc are 89% and 100%, respectively. among rgd (arg-gly-asp) peptides, crgdyk peptide (crgd) known as integrin ανβ3 and ανβ5 antagonist has been widely used for targeting various cancers including nsclc, glioblastoma, and colon carcinoma as well as prostate cancer. in this study, the investigators aim to analysis the expression of integrin ανβ3 in lung cancer patients.

patient samples: from the human resource bank of the institute of pathology, korea university, the investigators collected paraffin-embedded tissue sections from 61 patients with nsclc (adenocarcinoma =50, squamous cell carcinoma = 11) who had undergone surgical treatment for nsclc at korea university guro hospital between 2015 and 2018 under the irb of guro hospital 2019gr0460. samples were excluded when patients had undergone perioperative chemo- or radiotherapy. among the tissues excised from lung cancer patients, lung cancer and normal tissue were classified as pathologically, defined as normal tissue and cancer tissue, and stained with an integrin ανβ3 primary antibody.

Eligibility criteria:
inclusion criteria: * nsclc (adenocarcinoma or squamous cell carcinoma) who had undergone surgical treatment for nsclc at korea university guro hospital between 2015 and 2018 exclusion criteria: * patients had undergone perioperative chemo- or radiotherapy
allogeneic natural killer (nk) cell therapy in patients with lymphoma or solid tumor

Conditions: Malignant Lymphomas; Solid Tumors

Summary: allogeneic natural killer (nk) cells (mg4101) were manufactured from normal healthy donor who underwent leukapheresis. these cells were processed based on a novel method for ex vivo activation and expansion using an irradiated and activated autologous feeder cell system. mg4101 has anti-tumor activities against various tumors including malignant lymphomas in vitro as well as in vivo tumor model.


Eligibility criteria:
inclusion criteria: * age 18 years or older * histologically or cytologically confirmed malignant lymphoma or solid tumor * after the failure of standard treatment * kps \>70 or ecog ps 0-2 * adequate bone marrow, renal, and liver functions * expected survival at least 3 months * informed consent exclusion criteria: * pregnancy or lactating woman * hiv patients * prior exposure to cell-based therapy * hypersensitivity to interleukin-2 * patients with autoimmune disease

Keywords: allogenetic nk cells lymphomas solid tumors