Kornimate/medical-research-clean huggingface dataset:
parallel arm trial of ad109 and placebo with patients with osa (lunairo)

Conditions: OSA

Summary: this is a phase 3 randomized double-blind placebo-controlled 1-year parallel-arm study to compare a fixed dose combination of ad109 to placebo in obstructive sleep apnea.


Eligibility criteria:
inclusion criteria: 1. ≥18 years of age at the time of informed consent. 2. psg criteria: ahi of \>5; ≤ 25% central or mixed apneas; and plm arousal index ≤15 3. promis-fatigue: raw score ≥17 4. pap intolerance or current pap refusal. 5. bmi between 18.5 and 40 kg/m2 for men, or 42 kg/m2 for women, inclusive. exclusion criteria: 1. narcolepsy, restless leg syndrome, rem sleep behavior disorder 2. insomnia disorder characterized by difficulty initiating or maintaining sleep, or use within the past month of sedative-hypnotics or other medication for the purpose of treating or avoiding insomnia symptoms. 3. pierre robin, treacher collins, or other craniofacial malformation syndrome, or grade ≥3 tonsillar hypertrophy. 4. clinically significant cardiac disease, e.g., ventricular arrhythmia, untreated or unstable coronary artery disease, cardiac failure. stable atrial arrhythmia is allowed. 5. neuromuscular disorder (e.g., motor neuron disease, muscular dystrophy or myopathy, myasthenic syndrome); epilepsy; parkinson, alzheimer, or other neurodegenerative disease.

Keywords: obstructive sleep apnea
mitochondrial donation: an 18 month outcome study.

Conditions: Mitochondrial Diseases

Summary: the investigator proposes to record the fetal and postnatal development of children conceived using mitochondrial donation (md) and to perform expert assessment of development at 18 months (corrected for gestational age) using the internationally validated bayley-iii developmental assessment tool.

to record the fetal and postnatal development of children conceived using mitochondrial donation and to perform internationally validated bayley-iii developmental assessment tool at 18 months (corrected for gestational age). the null hypothesis for this research is that children born following the use of mitochondrial donation (ivf) techniques have normal neurodevelopment developmental outcomes at 18 months.

Eligibility criteria:
inclusion criteria: women will only be eligible if they meet all of the following criteria. * women with confirmed mtdna mutation * suitable to undergo mitochondrial donation as a treatment (in line with hfea license) * informed consent for the study obtained before mitochondrial donation treatment commences * ability and willingness to adhere to the protocol including evaluation schedule * willingness to make available information collected during pregnancy, delivery and up to the child's age of 18 months (corrected for gestational age) exclusion criteria: women will not be eligible if they meet any of the following criteria * declined mitochondrial donation as a treatment (in line with hfea license) * inability or unwillingness to adhere to the protocol including evaluation schedule * unwillingness to make available information collected during pregnancy, delivery and up to the child's age of 18 months (corrected for gestational age)
a study on efficacy and safety of topiramate oros controlled-release in obese, type 2 diabetic subjects managed with diet or metformin

Conditions: Obesity; Diabetes Mellitus, Type 2; Diabetes Mellitus, Adult-Onset

Summary: the purpose of this study is to evaluate the effectiveness and safety of a topiramate controlled-release formulation in the treatment of obese, type 2 diabetic patients managed with diet alone or combined with metformin.

topiramate is not approved for the treatment of obesity. studies have shown that an immediate release formulation of topiramate reduces body weight in obese patients with or without type 2 diabetes. a novel controlled-release formulation of topiramate using oros® technology has the potential for better efficacy and safety in the treatment of obesity. this double-blind, placebo controlled study will evaluate the effectiveness and safety of the controlled-release formulation in the treatment of obese subjects with type 2 diabetes. the study consists of 2 screening visits, a baseline visit, 7-week titration phase (topiramate dose will be increased from 25mg daily to 175mg daily), 9-week maintenance phase, 2-week taper phase and a 2-week follow-up. effectiveness will be evaluated by the percent change in body weight, body mass index, and anthropometric measurements (waist and hip circumferences and their ratio). safety evaluations (incidence and severity of adverse events, physical measurements and clinical laboratory tests) will be conducted throughout the study. the study hypothesis is that topiramate 175 mg daily, when administered as the oros® controlled-release formulation, is effective (in terms of percent reduction in body weight from baseline to week 16) and safe, as compared with placebo, in the treatment of obese, type 2 diabetic patients managed with either diet alone or combined with metformin. during the titration phase, topiramate (in the oros® controlled-release formulation) will be gradually increased to 175mg daily by mouth, and the dose will be maintained for 9 weeks, and then slowly discontinued over 2 weeks.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) \>= 27 kg/m\^2 and \<50 kg/m\^2 * diagnosis of type 2 diabetes, managed with either diet alone or combined with monotherapy treatment with metformin * stable weight for at least 2 months * female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test). exclusion criteria: * contraindication or hypersensitivity to topiramate * exposure to any other experimental drug or device within past 90 days * established diagnosis of type 1 diabetes * history of severe or recurrent hypoglycemic episodes prior to study entry * taking oral antidiabetic medications other than metformin * treatment with insulin within 4 months * significant liver, kidney or cardiovascular diseases.

Keywords: obesity type 2 diabetes mellitus metformin diabetic diet topiramate adult-onset diabetes mellitus (aodm)
severity of the new uk sars-cov2 variant in covid-19 infection

Conditions: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Summary: the covid-19 epidemic has now raged for more than a year with more than 100 million identified cases and nearly 2.5 million deaths worldwide. since november 2020, we have been witnessing the emergence of viral variants in different regions of the world. this expected genetic drift of the virus, but somewhat abrupt since november, raises questions concerning the characteristics of transmissibility, pathogenicity, sensitivity to possible treatments, and escape from natural or vaccine immunity. the objective of this study is to find out whether the new variants of sars-cov-2 are associated with particular clinical forms. the results of this research will provide elements to determine whether the new variants of sars-cov-2 are associated with more severe clinical forms.

sevasar is a paired cohort study with retrospective data collection: * presentation: patients hospitalized for covid-19 with sars-cov-2 variant 20i / 501y.v1 * not exposed: patients hospitalized for covid-19 with sars-cov-2 corresponding to wild variants type 20a. eu1 or 20a. eu2 the severity of illness will be compared between pairs. disease severity will be assessed according to the following definition: defined by a composite criterion including, at 28 days after hospital admission: who scale \>5 /11 levels, (death or need for invasive ventilation or need for high flow ventilation (optiflex or niv or cpap) or high concentration mask. this event will be taken into account regardless of its time of occurrence between the first day of the hospitalization studied and d29 after hospital admission.

Eligibility criteria:
inclusion criteria: * adult * acute symptomatic pcr + covid with screening * hospitalized for acute covid between 01/01/2021 (or since the setting up of the screening in the center) and 02/28/2021 exclusion criteria: * opposition to participation * identification of variants other than 20i / 501y.v1 * patients infected with sars-cov-2 in a nosocomial context
pharmacokinetic evaluation of nalmefene administered intranasally to healthy volunteers

Conditions: Opioid-Related Disorders

Summary: this study will be to compare the pharmacokinetics of nalmefene administration intranasal with and without an absorption enhancer compared to an intramuscular injection.

this study will be an inpatient, double-blind, randomized, crossover study involving 14 healthy volunteers. each subject will receive 4 treatments during the 4 dosing periods.subjects will stay in the inpatient facility for 17 days to complete the entire study and be discharged following completion of discharge procedures at the end of the last period. subjects will be called 3 to 5 days after discharge to inquire concerning adverse events and concomitant medications since discharge. after obtaining informed consent, subject will be screened for eligibility. on the day after clinic admission, subjects will be administered the intranasal-formulated drug in randomized order with 4 days between doses; the intramuscular dose will be administered during the fourth (last) treatment period.

Eligibility criteria:
inclusion criteria: * males and females 18 to 55 years of age * provide written informed consent * body mass index (bmi) ranging from 18 to 32 kg/m2 * adequate venous access * no clinically significant concurrent medical conditions * males subjects must agree to use an acceptable method of birth of contraception with female partners as well as not to donate sperm throughout the study and for 90 days after the last study drug administration * female subjects of child bearing potential must agree to use an acceptable method of birth control from the start of screening until 30 days after completing the study. oral contraceptives are prohibited * agree not to ingest alcohol, drinks containing xanthine \>500 mg / day (e.g., coca cola, tea, coffee, etc.), or grapefruit/grapefruit juice or participate in strenuous exercise 72 hours prior to admission through the last blood draw of the study exclusion criteria: * please contact the site for more information
a phase 1 study to evaluate the effect of dimebon on the pharmacokinetics of dextromethorphan

Conditions: Huntington Disease; Alzheimer Disease

Summary: this drug-drug interaction study is being conducted to evaluate the potential effect of dimebon on the pharmacokinetics on dextromethorphan, a probe substrate of the cytochrome p450 2d6 (cyp2d6) enzyme, after multiple dose administration to healthy adult subjects.


Eligibility criteria:
inclusion criteria: * healthy adult subjects. * extensive or ultra-rapid metabolizers of cyp2d6 substrates, predicted by genotype. exclusion criteria: * existence of significant medical conditions that would impact study results or pose unacceptable risks to study subjects. * pregnant or nursing females or females of childbearing potential who are unwilling or unable to use an acceptable method of contraception. * use of prescription or nonprescription drugs and dietary supplements within 7 days prior to the first dose of study medication.
randomized trial of adjuvant chemotherapy with cisplatin followed by uft in serosa-positive gastric cancer (jcog9206-2)

Conditions: Gastric Neoplasm

Summary: to evaluate the survival benefit of adjuvant chemotherapy after curative resection with d2 or greater lymph node dissection in t3-4 gastric cancer patients.

purpose: to evaluate the survival benefit of adjuvant chemotherapy after curative resection in serosa-positive gastric cancer patients, a multicenter phase iii clinical trial was conducted by 13 participating centers in japan. methods: from january 1993 to march 1998, 268 patients were randomized to either adjuvant chemotherapy (135 pts) or surgery alone (133 pts). the chemotherapy comprised intraperitoneal cisplatin 70 mg/m2 before closing the abdomen, and after surgery intravenous cisplatin 70 mg/m2 (day 14) and 5-fluorouracil (5-fu) 700 mg/m2 daily (day 14-16), and oral fu (uft) 267 mg/m2 daily from 4 weeks after surgery for the next 12 months. the primary endpoint was overall survival. relapse-free survival and the site of recurrence were secondary endpoints. comparison: gastrectomy with d2 or greater lymph node dissection versus gastrectomy with adjuvant chemotherapy after curative resection in serosa-positive gastric cancer patients.

Eligibility criteria:
inclusion criteria: 1. curative operation with d2 or greater lymph node dissection 2. histologically proven gastric adenocarcinoma 3. macroscopically serosa-positive (t3-4) 4. no metastases to level 3 - 4 lymph nodes station (n0-2) 5. 75 years or younger 6. negative peritoneal lavage cytology 7. adequate organ function wbc \>=4000/mm3,hb \>=11.0g/dl,plt \>=100.000/mm3,ast/alt, t.bil, bun, creatinine \<=2.5 x normal upper limit,creatinine clearance \<=70 ml/min 8. written informed consent exclusion criteria: 1. prior chemotherapy or radiotherapy 2. synchronous or metachronous malignancy in other organs

Keywords: gastric neoplasm gastrectomy adjuvant chemotherapy randomized trial t3 and t4 carcinoma of the stomach/gastric neoplasm
french observational xagrid (fox) study in adult patients with essential thrombocythemia

Conditions: Essential Thrombocythemia

Summary: this is an observational study to explore how different treatment regimens affect continuation with treatment in the first 6 months following initiation of xagrid into adult patients' essential thrombocythemia therapy.


Eligibility criteria:
inclusion criteria 1. patients aged 18 years and older. 2. high-risk et patients, uncontrolled by first-line (or previous) cytoreductive treatment for efficacy or tolerance reasons. 3. patients who have been on second- or third-line xagrid treatment for up to 1 month, or for whom a decision has been documented to commence second line xagrid treatment. 4. patients able to understand and able and willing to participate in the study, and provide a personally dated and signed written informed consent form. exclusion criteria 1. patients with a known or suspected intolerance or hypersensitivity to xagrid, closely related compounds, or any of the stated ingredients. 2. patients for whom there is an intention to treat with combinations of cytoreductive therapy. 3. patients participating in a separate clinical trial where their treatment is defined by that study protocol.
ph2 trial in patients with relapsed/refractory chronic lymphocytic leukemia (cll) with a combination of bendamustine & ofatumumab

Conditions: Chronic Lymphocytic Leukemia (CLL)

Summary: investigational drugs: ofatumumab (azerra) + bendamustine (trenda) route of administration: intravenous (iv) hypothesis: this study is designed to assess the toxicity and overall response rate. ofatumumab is a fully human monoclonal antibody (a type of protein made in the laboratory that can bind to substances in the body, including tumor cells) that shows promising activity in the treatment of cll as a single agent. it is thought that by combining it with bendamustine, an fda approved treatment for cll, the effect on cll will be greater than if ofatumumab is given alone. ofatumumab is fda approved for the treatment of relapsed/refractory cll. participation: approximately 37 relapsed/refractory cll subjects will participate in this study over two years. treatment plan: a maximum of 6 cycles of treatment will be allowed. during day 1 of cycle 1 ofatumumab iv 300mg will be administered. on day 1 of all cycles ofatumumab treatment will be followed by bendamustine iv 90mg/m2. on day 2 of all cycles, bendamustine iv 90mg/m2 will be administered. on day 3 of all cycles, neulasta sq 6mg will be given. on day 8 of cycle 1 only patients will receive ofatumumab iv 1000mg. during cycles 2 through 6 ofatumumab 1000mg will be given on day 1 only. follow-up: patients will be followed monthly for six months, then every three months for five years then annually thereafter.


Eligibility criteria:
inclusion criteria: * must be \>/= 18 years old and able to provide consent * must have diagnosis of cll as defined by nci criteria * must require chemotherapy * must be previously treated with a minimum of one course of prior chemo or other treatment * serum creatinine \<1.8 mg/dl * bilirubin must be \</= 2 mg/d, unless secondary to tumor * must have adequate liver function (as defined as \<2x uln, unless related to cll) * ast/alt \<2x uln * performance status 0-2 * women of child bearing age must be willing to use accepted/effective method of birth control. exclusion criteria: * not have received prior treatment with cytotoxic chemotherapy or immunotherapy. * not have autoimmune hemolytic anemia or autoimmune thrombocytopenia * not have history of corticosteroid treatment for cll * not have cns disease * not have clinically significant infections * patients with a second malignancy, other than basal cell carcinoma of the skin or in situ carcinoma of the cervix are not eligible. * not have positive serology for hepatitis b or hepatitis c * not have be known to be hiv positive * not have new york classification iii or iv hear disease other protocol specific criteria may apply

Keywords: cll bendamustine ofatumumab blood cancer leukemia lymphoma lymphocyte refractory advanced relapsed hematologic hematology antibody non-hodgkin lymphoma small lymphocytic lymphoma nevada cancer institute cephalon glaxosmithkline
the treatment effect of bio-three on children with enteritis

Conditions: Gastroenteritis; Diarrhea

Summary: diarrhea due to acute enteritis is a common symptom in the children. lots of patients are infected by rotavirus or salmonella. base on the past researches, there is benefit effect of probiotics on patients with diarrhea or acute enteritis. in this clinical study, bio-three, a probiotic which contains three independent probiotics, will be used in patients with acute diarrhea. this is a single site, controlled clinical research. about 80 patients will be enrolled into this study to evaluate the benefit effect of bio-three among patients with acute enteritis due to rotavirus or salmonella or other unknown reason. patients will be diagnosed and screened by inclusion and exclusion criteria and only eligible patients will be enrolled into this study.

intervention: subjects were randomly assigned to receive control treatment (intravenous fluid, oral rice and half strength milk formula) or add-on treatment of the probiotics (bio-three®) to the control treatment. main outcome measures: quantitative vesikari scales and qualitative severe diarrhea (vesikari scale≥11) exclusion criteria included immunodeficiency, severe abdominal distension with risk of bowel perforation, severe infection or sepsis, history of gastrointestinal tract surgery, and probiotics use in the preceding 1 week.

Eligibility criteria:
inclusion criteria: * clinical symptom of diarrhea less than 3 days exclusion criteria: * severe abdominal distension with risk of bowel perforation * risk for sepsis * past history with surgical operation of gastrointestinal tracts * immunodeficiency * probiotics use in the preceding 1 week

Keywords: probiotics pediatric salmonella rotavirus gastroenteritis
mechanical ventilation controlled by the electrical activity of the patient's diaphragm - effects of changes in ventilator parameters on breathing pattern

Conditions: Mechanical Ventilation

Summary: neurally adjusted ventilatory assist (nava) is a new concept of mechanical ventilation. nava delivers assist to spontaneous breathing based on the detection of the electrical activity of the diaphragm. we study the effect of changing ventilatory parameters on the patient's breathing pattern during nava.


Eligibility criteria:
inclusion criteria: * invasive mechanical ventilation (tracheally intubated or tracheotomized) * presence of an arterial pressure line. * subject itself or its next of kin has given written informed consent exclusion criteria: * patient is less than 18 years or more than 85 years of age * the attending physician refuses to allow enrollment * the patient refuses informed consent * next of kin is unavailable or refuses informed consent * pregnant or breast-feeding female. a pregnancy test will be performed in all female patients less than 60 years of age. * any contraindication to insertion/exchange a nasogastric tube, including (but not limited to): severe oropharyngeal malformation or bleeding; esophageal varices, tumor, infection, stenosis, or rupture * presence or suspicion of diaphragm injury * hemophilia or other severe bleeding disorder * presence or suspicion of a central nervous system (cns) disorder, including (but not limited to): cns infarction, bleeding, tumor, or infection * history of heart and/or lung transplantation * any mechanical cardiac assist device (excluding intraaortic balloon pump) * any contraindication to reduce sedation or to stop neuromuscular blockage in order to allow spontaneous breathing * the patient needs to be ventilated with a mode of mechanical ventilation that targets a predefined tidal volume or airway pressure as per attending physician * severe hemodynamic instability as per attending physician * planned or anticipated intervention within the study period necessitating either transfer out of the icu or requiring prolonged interaction with the patient. * a fraction of inspired oxygen (fio2) of \> 0.8 * the patient currently participates in another interventional clinical trial
js-201 combined with lenvatinib in the treatment of small-cell lung cancer

Conditions: Small-cell Lung Cancer

Summary: this is a prospective, single-arm phase ii clinical study to evaluate the efficacy and safety of js-201 combined with lenvatinib in the treatment of small-cell lung cancer that has failed previous chemotherapy combined with pd-l1. the primary observational endpoint is orr, and the secondary observational endpoint is pfs, os. the intervention mode is js201 300mg i.v q2w, lenvatinib 8mg po. qd.


Eligibility criteria:
inclusion criteria: * 1. the imaging diagnosis is the extensive stage of sclc * 2. the patient failed first-line ec+pd-l1 treatment * 3 ps 0-1 exclusion criteria: * 1. diagnosed as non-small cell lung cancer * 2. women during pregnancy * 3. patients with symptomatic brain metastases * 4. ps≥2
continuous central venous lactate monitoring by intravascular microdialysis : a comparison to sequential arterial lactate measurement during shock.

Conditions: Shock

Summary: during shock, arterial hypotension, inadequate cardiac output and microcirculatory alterations lead to tissue hypoxia, multiple organ failure and death. arterial lactate is considered as the best marker of tissue hypoxia. a lactate decrease during the first 6 hour is strongly associated with better outcome and may be used as a target for assessing the efficiency of shock resuscitation. the eirus system (maquet critical care ab, 17154, solna, sweden) is a new device allowing the continuous measurement of venous lactate through a central venous catheter. however, before being used extensively, such device needs to be evaluated concerning its accuracy. the aim of the present study is to assess the reliability of this device.


Eligibility criteria:
inclusion criteria: acute circulatory failure defined as : systolic blood pressure\ 2mmol/l exclusion criteria: pregnant women

Keywords: lactic acid