Kornimate/medical-research-clean huggingface dataset:
a multiple dose study of ly3502970 in healthy overweight and obese participants

Conditions: Healthy; Obese

Summary: the main purpose of this study is to evaluate how much ly3502970 gets into the bloodstream and how long it takes the body to eliminate when administered orally as tablet and capsule formulations along with effect of food on ly3502970 in healthy overweight and obese participants. the study will also evaluate the safety and tolerability of ly3502970 in these participants. the study is conducted in two parts (part a and b) and will last up to 135 days including the screening period.


Eligibility criteria:
inclusion criteria: * male or female participants who are overtly healthy as determined by medical evaluation * participants with body mass index (bmi) of 27.0 kilograms per meter squared (kg/m²) or more * participants with a stable body weight, with 5% or less body weight gain or loss exclusion criteria: * have any type of diabetes with hemoglobin a1c (hba1c) level of 6.5% or greater or a fasting blood sugar over 120 milligram per deciliter (mg/dl) * obesity induced by other endocrine disorders, such as cushing's syndrome or prader-willi syndrome * have known clinically significant gastric emptying abnormality * have undergone bariatric surgery (for example: lap-band, gastric bypass) * known self or family history (first-degree relative) of multiple endocrine neoplasia type 2a or type 2b, thyroid c-cell hyperplasia, or any form of thyroid cancer * have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drug * have significant history of or currently have major depressive disorder or psychiatric disorder within the last 2 years
clinical trial readiness network fshd france: prospective 24 months mri study

Conditions: Muscular Dystrophy; Facioscapulohumeral

Summary: the overall aim of this study is to hasten drug development for facioscapulohumeral muscular dystrophy (fshd). recent breakthroughs in fshd research have identified the primary disease mechanism as the aberrant expression of a normally silenced gene, dux4, resulting in a toxic gain-of-function. this disease mechanism is particularly amenable to knock-down of dux4 using epigenetic strategies or rna therapies, as well as to other interventions targeting the downstream effects of dux4 expression. there are many drug companies actively working towards disease-targeted therapies, and two clinical trials either under way now, or planned to start in early fall 2016. however, meetings with industry, advocacy groups, and fshd researchers have identified several gaps in the clinical trial arsenal, and clinical trial planning as a major goal for the community. consequently, there is an urgent need to establish the tools necessary for the conduct of currently planned and expected therapeutic trials in fshd. to this end, the researchers propose to develop two novel clinical outcome assessments (coa), a composite functional outcome measure (fsh-com) and skeletal muscle biomarker, electrical impedance myography (eim). in addition there is broad consensus a better understanding of the relationship of genetic and demographic features to disease progression will be necessary for enumerating eligibility criteria. the specific aims are to: 1. determine the multi-site validity of the coas, 2. compare the responsiveness of new coas to other fshd outcomes and determine the minimal clinically meaningful changes, and 3. establish fshd cohort characteristics useful for determining clinical trial eligibility criteria. to achieve these aims, the nice university hospital is conducting a monocentric, prospective, 18 month study on 30 subjects.


Eligibility criteria:
inclusion criteria * genetically confirmed fshd1 or clinical diagnosis of fshd with characteristic findings on exam and an affected parent or offspring 63 * age 18-75 years * symptomatic limb weakness * patient able to walk alone or with a walking aid. * manual muscle testing (mmt) score ≥ 4 for one of the lower limb muscles * patient affiliated to the social security system * patient giving written consent after written and oral information. * if taking over the counter supplements willing to remain consistent with supplement regimen throughout the course of the study exclusion criteria * cardiac or respiratory dysfunction (deemed clinically unstable, or would interfere with safe testing in the opinion of the investigator) * orthopedic conditions that preclude safe testing of muscle function * regular use of available muscle anabolic/catabolic agents such as corticosteroids, oral testosterone or derivatives, or oral beta agonists * use of an experimental drug in an fshd clinical trial within the past 30 days * pregnancy. * contraindication for muscle mri * any major comorbidity
influenza vaccination and oral anticoagulant therapy

Conditions: Anticoagulants; Influenza Vaccines

Summary: the purpose of this study is to evaluate inr and inr related index and warfarin weekly dosage variations after influenza vaccination

the pharmacokinetic and the pharmacodynamic interactions and the possible clinical events connected with the simultaneous administration of oral anticoagulants (oa) and the influenza virus vaccine were evaluated in several small studies which yielded conflicting results, thus encouraging additional investigations with prospective studies in order to obtain a more consistent evidence about the safety and efficacy of vaccination against influenza virus in patients on oa treatment.

Eligibility criteria:
inclusion criteria: * oa treatment * stable anticoagulation (previous two controls in range) * presence of indication for influenza vaccination * life expectancy \> 6 months * signed informed consent exclusion criteria: * absence of stable anticoagulation * absence of indication for influenza vaccination * life expectancy \< 6 months * denied informed consent

Keywords: oral anticoagulants influenza virus influenza vaccine pharmacological interference
an immuno-therapy study of nivolumab in combination with experimental medication bms-986205 compared to standard of care extreme regimen in first-line recurrent/metastatic squamous cell carcinoma of head and neck

Conditions: Head and Neck Cancer

Summary: this is a study of nivolumab in combination with experimental medication bms-986205 compared to the standard of care extreme regimen in head and neck cancer that has come back after initial treatment, or is widespread when first diagnosed.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * histologically confirmed squamous cell carcinoma of the head and neck (scchn), from any of the following primary sites only: oral cavity, oropharynx, hypopharynx, and larynx. * recurrent or metastatic disease that is not amenable to therapy with curative intent (surgery or radiation therapy with or without chemotherapy) * no prior treatment with systemic anti-cancer therapy for scchn, unless protocol specified criteria are met * ecog performance status of 0-1 * measurable disease by ct or mri per recist 1.1 criteria exclusion criteria: * women who are pregnant or breastfeeding * recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, squamous cell carcinoma that originated from the skin and salivary gland or paranasal sinus, non-squamous histologies (eg, mucosal melanoma) * participants with untreated cns metastases are excluded * participants with carcinomatous meningitis * prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast other protocol defined inclusion/exclusion criteria could apply
human breastmilk in young children with norovirus infection of the gut

Conditions: Norovirus Infections

Summary: human breast milk in young children with norovirus infection

the investigators hypothesize that children with clinically significant norovirus infection of the gut who receive enteral human milk will more successfully clear the virus or experience improved symptoms compared to children not receiving human milk.

Eligibility criteria:
inclusion criteria: * children with at least two stool samples taken at least 7 days apart that are positive for norovirus * child has an underlying disease or has received immunosuppressive medication or chemotherapy such that clearance of norovirus is expected to be impaired. exclusion criteria: * the presence of other pathogens causing diarrhea that have specific treatments does not preclude enrollment. however, specific treatment should be offered in addition to human milk.

Keywords: stem cell transplant human breastmilk
effect of transversus abdominis plane block with compound lidocaine and esketamine on pain after surgery

Conditions: Postoperative Pain

Summary: purpose: to explore effects of ultrasound-guided transversus abdominis plane block with compound lidocaine and esketamine on postoperative pain after colorectal cancer surgery.

poor post-surgical pain control is a leading factor that hinders the physical rehabilitation, and causes acute cognitive impairment and chronic pain syndrome. recently, the multimodal analgesia strategies to minimise opioid related side effects are highly desirable in open surgical procedures. the transversus abdominis plane block is a novel technique involving injection of local anaesthetic between the internal oblique and the transversus abdominis muscles of the abdominal wall. although ropivacaine is most commonly used for this technique, the analgesic duration remains not dissatisfied. compared with ropivacaine, compound lidocaine injection has a better and longer analgesic activity since it contains menthol and ethanol with appropriate concentrations. however, whether compound lidocaine injection is efficiency in the transversus abdominis plane block for abdominal surgery lacks investigations. herein, we will evaluate the efficacy of ultrasound-guided transversus abdominis plane (usg-tap) block with compound lidocaine injection and esketamine for postoperative analgesia in patients undergoing colorectal cancer surgery.

Eligibility criteria:
inclusion criteria: 1. subject is scheduled to undergo colorectal cancer surgery under general anesthesia 2. subject's american society of anesthesiologists physical status is i-ii. 3. the subject's parent/legally authorized guardian has given written informed consent to participate. exclusion criteria: 1. subject has a diagnosis of bronchial asthma, coronary heart disease, severe hypertension, renal failure or liver failure. 2. subject has a diagnosis of insulin dependent diabetes. 3. subject is allergy and contraindication to local anesthetics or any components of local anesthetics. 4. subject has a history of chronic pain, a history of alcohol or opioid abuse, pre- existing therapy with opioids, intake of any analgesic drug within 48 hours before surgery. 5. subject has any contraindication for the use of patient-controlled analgesia (pca). 6. subject is pregnant or breast-feeding. 7. subject is obese (body mass index \>30kg/m\^2). 8. subject is incapacity to comprehend pain assessment and cognitive assessment.

Keywords: compound lidocaine ropivacaine transversus abdominis plane block opioid consumption
the effect of neurorehabilitation therapy on postural control, mobility and quality of life in multiple sclerosis patients

Conditions: Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis, Primary Progressive

Summary: abstract introduction: postural control disorders are the most common motor disorder associated with multiple sclerosis. objective: the aim of this study is to demonstrate the potential for improvement of postural control, motion performance and quality of life in patients with multiple sclerosis who are performing a special neurorevolutionary balancing program. intervention: the treated group (n = 15) performed five times a week for the treatment we defined. (60 minutes per day). the experimental group performed movements using the xbox 360 and kinect consoles. the study team participated in 25 sessions, five times a week. the duration of treatment was 5 weeks.the mstp group (n=14) participated in a 5-week physiotherapy course. the general treatment consisted of strengthening, stretching and walking correction. during the 5-week period, 25 patients attended training. one treatment takes 60 minutes. sensory organisation test / body sway at the end of the baseline and treatment protocol is used to evaluate each patient. the quality of life mapping was measured by subjective tests (eq-5d-5l, adl). to assess the depressive state, a beck depression questionnaire was used. balance and motion performance were used by the berg balance test and 6minutes walk test. the results were compared with the control group results (n = 14) and showed improvement in overall balance and motion performance.


Eligibility criteria:
inclusion criteria: * multiple sclerosis * instability problem exclusion criteria: * severe heart problems, severe demeanor, alcoholism, drug problems

Keywords: multiple sclerosis posture neurorehabilitation balance
camellia: anti-cd47 antibody therapy in haematological malignancies

Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndrome

Summary: this phase i trial studies the side effects and best dose of anti-cluster of differentiation (cd)47 monoclonal antibody hu5f9-g4 in treating patients with haematological malignancies including acute myeloid leukemia that has returned after a period of improvement (relapsed) or has not responded to previous treatment (refractory), or high risk myelodysplastic syndrome. monoclonal antibodies, such as anti-cd47 monoclonal antibody hu5f9-g4, block cancer growth in different ways by targeting certain cells.


Eligibility criteria:
key inclusion criteria: * pathologically confirmed relapsed or refractory (primary refractory and relapsed refractory) acute myeloid leukemia (aml) (defined by world health organization (who) criteria) for which no further conventional therapy is suitable for the patient, or confirmed myelodysplastic syndrome defined according to who classification, with an international prognostic scoring system (ipss) risk category of intermediate-2 or high risk, that is relapsed, refractory or intolerant to conventional therapy within 3 weeks of registration. * male or female, age ≥ 18 years. * eastern cooperative oncology group (ecog) performance score of 0-1 * willing to undergo blood transfusions as deemed clinically necessary. * adequate hematological, liver, and kidney function key exclusion criteria: * females: pregnant or breast-feeding women, or women of childbearing potential unless effective method of contraception is used during and for 3 months after the trial. males: unless an effective method of contraception is used during and for 3 months after the trial. * any prior exposure to hu5f9-g4 or other cd47 targeting agents. * treatment with any other investigational agent within 28 days prior to enrolment. * previous allogeneic stem cell transplant within 6 months prior to enrolment, active graft vs host disease (gvhd), or requiring transplant-related immunosuppression * evidence for active cns involvement by leukaemia * clinical evidence or known history of cardiopulmonary disease
phase 2 study to evaluate the preliminary performance of the c13-ura breath test kit in dyspeptic subjects

Conditions: Dyspeptic Subjects

Summary: this study is a multi-center, open-label comparison study and aimed to evaluate the preliminary performance of this 13c-uracil gebt to examine its abilities of identifying abnormal (delayed) gastric emptying rates in subjects.

approximately equal numbers of subjects will be enrolled in each of the 2 groups (with normal gastric emptying, and with delayed gastric emptying (gastroparesis)) to complete at least 10 subjects per group. the subjects will first have their gastric emptying rates investigated by scintigraphy using the solid test meal containing 500 uci 99mtc sulfur colloid at visit 1. second, the subjects will have their gastric emptying rates investigated by scintigraphy and 13c-uracil gebt simultaneously using the semi solid test meal containing 500 uci 99mtc sulfur colloid and 100 mg of 13c-uracil, respectively, at visit 2. a comparison will be made between the results obtained at visits 1 and 2 along with a comparison of the data obtained during visit 2 for evaluation of the 13c-uracil gebt.

Eligibility criteria:
inclusion criteria: * body mass index \[range is 18.0 to 33.0 kg/m2 * subjects with any upper gi symptoms * stable creatinine exclusion criteria: * history of known peptic ulcers or stomach cancer. * history of stomach surgery or resection * history of significant hypersensitivity, intolerance, or allergy to any drug compound, food or other substance, unless approved by the investigator * history of alcoholism or drug abuse * history or presence of clinically significant gi, cardiovascular, central nervous system, hepatic, or renal disease; or other conditions * history of eating disorders * history or presence of an abnormal ecg, which, in the opinion of the investigator, is clinically significant
endometrial injury in recurrent implantation failure

Conditions: Infertility; Endometrial Diseases

Summary: the aim of this study is to investigate that the efficacy of the endometrial injury before ivf in recurrent implantation failure patients.

this is a prospective and randomized controlled trial investigating the effect of hysteroscopic endometrial injury for treatment of recurrent implantation failure. approximately 230 patients who had failed to achieve a clinical pregnancy after the transfer of at least four good-quality embryos in a minimum of three fresh or frozen cycles to a woman under the age of 40 years will be randomized into two groups. injury group will receive endometrial injury during their hysteroscopic procedure, whereas the control group (n=115) did not. this study will investigate that, whether the endometrial injury is beneficial in recurrent implantation failure patients to increase the odds of clinical pregnancy rates, live birth rates, and implantation rates.

Eligibility criteria:
inclusion criteria: * women under the age of 40 who met the rif definition * patients whose follicle-stimulating hormone (fsh) levels were ≤ 15 iu/ml exclusion criteria: * patients with congenital uterine anomalies * patients with asherman's syndrome * patients with uterine cavity distorted by myoma or endometrial polyps * patients with confirmed endometriosis or endometrioma * patients with bmi of \ 29.9

Keywords: recurrent implantation failure endometrial injury implantation hysteroscopy
a continuation clinical trial of oral vorinostat (mk-0683) in advanced cancers (mk-0683-007)

Conditions: Advanced Cancer

Summary: this study will evaluate the safety and tolerability of continuing vorinostat (mk-0683) dosing in cancer patients previously enrolled in one of five base studies (mk-0683-001, mk-0683-006, mk-0683-008, mk-0683-012, or mk-0683-013) who have shown benefit from receiving this drug.


Eligibility criteria:
inclusion criteria: * patient participated in one of the five vorinostat base protocols, has not shown tumor progression on that study, and has tolerated the study drug * patient did not withdraw from the base protocol * patient agrees to practice effective birth control during the study exclusion criteria: * patient is receiving other standard and/or investigational anticancer therapy * patient has any condition or disease that would interfere with compliance or pose addition risk in administering the study drug
anti propionibacterium(p.) acnes activity of epiduo® gel compared to benzoyl peroxide (bpo) 2.5% gel

Conditions: Acne Vulgaris

Summary: the purpose of this study is to evaluate the antibacterial activity of epiduo® gel (adapalene 0.1% / benzoyl peroxide 2.5% gel) on p. acnes compared to that of benzoyl peroxide 2.5% gel.


Eligibility criteria:
inclusion criteria: * subjects with facial acne, * subjects with high levels of p. acnes counts on the forehead exclusion criteria: * female subjects who are pregnant, nursing or planning a pregnancy during the study, * subjects with acne conglobata, acne fulminans, secondary acne * subjects with known or suspected allergy to one of the test product

Keywords: p. acnes, acne vulgaris
correlation of audiovisual features with clinical variables and neurocognitive functions in bipolar disorder, mania

Conditions: Bipolar Disorder, Manic; Artificial Intelligence; Neurocognition; Treatment Resistant Disorders; Affective Computing; Multi- Modal Analysis

Summary: the aim of this study is to show the physiological changes during manic episode in bipolar mania how much they differentiate from remission and healthy control. relation of audio-visual features as physiological changes and cognitive functions and clinical variables will be searched. the aim is to find biologic markers for predictors of treatment response via machine learning techniques to be able to reduce treatment resistance and give an idea for personalized treatment of bipolar patients.

the objective of this research protocol is to find audio-visual features which differentiates bipolar mani/ remission/ health/ simulation and predicts treatment response earlier and detect neurocognitive changes during mania/ remission and difference from the healthy control. during hospitalization in every follow up day (0th- 3rd- 7th- 14th- 28th day) and after discharge on the 3rd month, presence of depressive and manic features for patients was evaluated using young mania rating scale(ymrs) and montgamery- asberg depresyon scale (madrs). audiovisual recording is done by a video camera in every follow up day for patients and for healthy controls which includes also depression and mania simulation. cambridge neurophysiological assessment battery (cantab) were administered to both groups( for patients both in the manic phase and in the remission) to assess neurocognitive functions.

Eligibility criteria:
inclusion criteria: * diagnosis of bd type i, manic episode according to dsm-5 \[10\] given by the following doctor, * being informed of the purpose of the study and having given signed consent before enrollment. exclusion criteria: * being younger than 18 years or older than 60 years, * showing low mental capacity during the interview * expression of hallucinations and disruptive behaviors during the interview, * presence of severe organic disease, * presence of any organic disease that may affect cognition * having less than five years of public education * diagnosis of substance or alcohol abuse in the last three months (except nicotine and caffeine) * presence of cerebrovascular disorder, head trauma with longer duration of loss of consciousness, severe hemorrhage and dementia, * having electroconvulsive therapy in the last one year. for the healthy control group, the following additional criteria were considered for exclusion * presence of family history of mood or psychotic disorder, * presence of psychiatric disorder during interview or in the past.

Keywords: bipolar and related disorders mood disorders mental disorders behavioral symptoms cognitive functions simulation