Kornimate/medical-research-clean huggingface dataset:
a phase 2 study of radiprodil in subjects with drug-resistant infantile spasms (is)

Conditions: Infantile Spasms (IS)

Summary: the purpose of the study is to evaluate the safety and tolerability, the pharmacokinetics and the efficacy of radiprodil in abolishing clinical spasms in subjects with drug-resistant infantile spasms

the study is divided into 3 parts: part a - exploratory, part b - confirmatory, part c - open label extension

Eligibility criteria:
inclusion criteria: part a and b: * subject is male or female between 2 and 14 months of age * the diagnosis of infantile spasms (is) * subject has drug-resistant is part c: * subject participated in ep0078 part a and received 2 radiprodil treatment cycles * subject experienced a relapse of spasms during the down taper or within 5 half-lives (3 days) discontinuation of radiprodil treatment in cycle 2 of part a * electroencephalogram (eeg) on baseline part c is compatible with the diagnosis of infantile spasms exclusion criteria: part a and b: * more than 6 months have passed since the diagnosis of infantile spasms (is) * current treatment with cannabinoids * subject has hematocrit greater than 60 * subject has any medical condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study * subject has a history or current condition predisposing to respiratory dysfunction * current treatment with felbamate * current treatment with perampanel * ketogenic diet * clinically significant lab abnormalities * clinically significant abnormality on ecg that, in the opinion of the investigator, increases the safety risks of participating in the study * subject has a lethal or potentially lethal condition other than is, with a significant risk of death before 18 months of age such as non-ketotic hyperglycinemia * body weight is below 4 kg * known history of severe anaphylactic reaction secondary to medication intake or serious blood dyscrasias part c: * subject experienced any acute tolerability issues in either treatment cycle in part a which the investigator and the sponsor medical monitor consider a risk for further participation * subject met any withdrawal criteria in part a * subject has experienced any adverse effects or developed any new medical conditions since enrollment in part a which the investigator considers could significantly increase the safety risks of participating in part c

Keywords: radiprodil infantile spasms is infantile spasms epilepsy paediatrics drug-resistant west syndrome hypsarrhythmia
closed-loop system for oxygen delivery and exercise in chronic obstructive pulmonary disease

Conditions: COPD; Oxygen Therapy; Hypercapnia

Summary: the purpose of this study is to investigate the benefit of closed-loop system for oxygen delivery (freeo2) as compared with fixed oxygen flow during endurance shuttle walking test in patients with chronic obstructive pulmonary disease (copd), oxygen therapy and hypercapnia. the study was designed to test the following hypotheses: as compared with fixed oxygen flow, the freeo2 oxygen delivery system leads to higher exercise tolerance (distance during eswt) and lower desaturation events without increase in hypercapnia in patients with copd, oxygen therapy and hypercapnia. as compared with fixed oxygen flow, the freeo2 oxygen delivery system leads to lower dyspnea and leg fatigue scores at a given endurance time during the shuttle walking test in patients with copd, oxygen therapy and hypercapnia. as compared with fixed oxygen flow, the freeo2 oxygen delivery system leads to lower cardiac and respiratory frequencies at a given endurance time during the shuttle walking test in patients with copd, oxygen therapy and hypercapnia.

background: in spite of oxygen therapy, desaturations frequently occur during exercise in copd patients. although current recommendations are to add 1 l/min to the baseline oxygen flow during exertion, a new closed-loop system (freeo2) automatically and continuously adjusts the oxygen flow to the patient's needs based on the oxygen saturation by pulse oximetry (spo2), end-tidal co2 (etco2) and respiratory rate. a preliminary study showed significant improvement in exercise tolerance in copd patients not needing oxygen therapy. although oxygen flow could be two fold increased during exercise, a worsening hypercapnia is plausible in severe copd. aim of this study is to evaluate this system during endurance shuttle walking test in copd patients with oxygen therapy and hypercapnia. methods: the investigators proposed to conduct a controlled, randomized cross-over study comparing the efficacy of a closed-loop system for oxygen delivery (freeo2) as compared with fixed oxygen flow during an endurance shuttle walking test in patients with copd, oxygen therapy and hypercapnia.

Eligibility criteria:
inclusion criteria: * 40 years and older * patient with copd severe to very severe requiring long-term oxygen therapy * hypercapnia (paco2 \> 45mmhg) * former or current smoker greater than or equal to 10 pack-years exclusion criteria: * pregnant or breast-feed woman * patients under guardianship * imprisoned patients
study of zanubrutinib (bgb-3111) in participants with marginal zone lymphoma

Conditions: Marginal Zone Lymphoma; MZL

Summary: this is a single arm study to evaluate the efficacy, safety and tolerability of zanubrutinib (bgb-3111) in participants with relapsed/refractory marginal zone lymphoma (r/r mzl).


Eligibility criteria:
key inclusion criteria: 1. age 18 years or older 2. histologically confirmed diagnosis of mzl including splenic, nodal, and extranodal subtypes 3. previously received one or more lines of therapy including at least one cd20-directed regimen (either as monotherapy or as chemoimmunotherapy) with documented failure to achieve at least partial response or documented progressive disease (pd) after, the most recent systemic treatment 4. current need for systemic therapy for mzl 5. measurable disease by computed tomography (ct) or magnetic resonance imaging (mri) 6. eastern cooperative oncology group (ecog) of 0-2 7. life expectancy ≥ 6 months 8. adequate bone marrow function 9. adequate organ function 10. male and female participants must use highly effective methods of contraception key exclusion criteria: 1. known transformation to aggressive lymphoma, eg, large cell lymphoma 2. clinically significant cardiovascular disease 3. prior malignancy within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized gleason score 6 prostate cancer 4. history of severe bleeding disorder such as hemophilia a, hemophilia b, von willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention 5. history of stroke or intracranial hemorrhage 6. severe or debilitating pulmonary disease 7. active fungal, bacterial and/or viral infection requiring systemic therapy 8. known central nervous system involvement by lymphoma 9. known infection with hiv, or serologic status reflecting active viral hepatitis b (hbv) or viral hepatitis c (hcv) infection 10. major surgery within 4 weeks of the first dose of study drug 11. prior treatment with a bruton's tyrosine kinase (btk) inhibitor 12. pregnant or lactating women 13. requires ongoing treatment with a strong cytochrome p4503a (cyp3a) inhibitor or inducer 14. concurrent participation in another therapeutic clinical trial note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: bgb-3111 zanubrutinib
drug use investigation for cervarix®

Conditions: Infections, Papillomavirus

Summary: this post-marketing study was designed to assess safety and efficacy of cervarix® vaccine in japanese female subjects under conditions of actual use.


Eligibility criteria:
inclusion criteria: * subject must be female * subject must be aged 10 and over exclusion criteria: * subject with obvious fever * subject with obvious severe acute disease * subject with hypersensitivity to any component of cervarix® * other than above, subject who is in inappropriate conditions for vaccination
bay79-4980 compared to rfviii-fs in previously treated patients with severe hemophilia a

Conditions: Hemophilia A

Summary: a study to assess treatment with a new formulation of recombinant factor viii reconstituted with liposomes (bay79-4980) to evaluate whether a once-a-week treatment is safe and can prevent bleeds in subjects with severe haemophilia a.


Eligibility criteria:
inclusion criteria: * males aged 12 to 70 years * subjects with severe hemophilia a (\< 1% factor viii \[fviii\]:c) * subjects with equal or greater than 150 exposure days (eds) with any fviii in total * subjects who have been on-demand treatment with a minimum of 1 relevant bleed per month or have been on secondary prophylaxis treatment with not more than a 3x/week schedule * subjects with bleeding events and/or treatments during the last 6 months prior to study entry which are documented in the subjects medical records * subjects with no measurable inhibitor activity * subjects with no history of fviii inhibitor antibody formation * written informed consent by subject and parent / legal representative, if \< 18 years exclusion criteria: * subjects who are receiving primary prophylaxis * subjects on prophylaxis with documented requirements of \> 75 iu/kg/week * subjects with any other bleeding disease beside hemophilia a (i.e., von willebrand disease) * subjects with abnormal renal function * subjects with elevated hepatic transaminases * subjects on treatment with immunomodulatory agents within the last 3 months prior to study entry or during the study * subjects with known hypersensitivity to the active substance, mouse or hamster protein, liposomes or polyethyleneglycol (peg) * subjects who require any pre-medication for fviii injections

Keywords: hemophilia a fviii disease rfviii
invasive versus echocardiography-derived transvalvular gradients after tavi usign balloon-expandable transcatheter heart valves.

Conditions: AORTIC VALVE DISEASES; Aortic Stenosis

Summary: the aim of this prospective registry is to compare invasive versus echocardiography-derived transvalvular gradients before and after tavi with balloon-expandable thvs.all patients will undergo a transthoracic echocardiogram in the operating room prior to aortic valve implantation. in addition, two catheters (one in the ventricle and one in the aorta) will be used to invasively measure the transvalvular gradient both before and after aortic valve implantation. the invasive measurements will be performed in different positions of the ventricle and aorta simultaneously. at the end of the procedure, aortic gradient measurement by echocardiography shall be performed again. a maximal three months follow-up is expected.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years and able to give consent * severe symptomatic native aortic valve stenosis with indication for tavi according to 2021 esc/eacts valvular heart disease guidelines. * use of balloon-expandable thv * written informed consent exclusion criteria: * emergency or urgent treatment indication * patients under hemodynamically unstable conditions. * previous bioprosthetic aortic valve implantation * patient cannot adhere to or complete the trial protocol for any reason

Keywords: invasive gradients haemodynamics aortic valve stenosis echocardiographic gradients
virtual reality effect on labor pain and satisfaction

Conditions: Satisfaction; Labor Pain

Summary: the primiparous women wore virtual glasses during labor, playing games and exercising. pregnant women were divided into two groups. experimental and control groups each consisted of 60 pregnant women.

aim: the research was carried out to determine the effect of virtual reality application in labor on perceived labor pain and satisfaction levels in primiparous. material and method: the study was conducted in a randomized controlled manner with a total of 120 primiparous women who applied to the delivery room of elazig fethi sekin city hospital between june 2020 and june 2021 (60 experiments, 60 controls). the pregnant women in the experimental group were played by the researcher during the active and transitional phases of labor with virtual reality glasses, which were designed for research and included methods used to cope with labor pain. except for routine care, no application was made to the pregnant women in the control group. in order to determine the pain level of the pregnant women, sds and scs were applied four times, before and after the virtual reality applications. after delivery, dme-c was applied to both groups.

Eligibility criteria:
inclusion criteria: * all pregnant women who were able to communicate verbally * between 37-42 weeks of pregnancy * single, live fetus and head presentation * cervical opening \<4 cm based on the labor follow-up form at admission to the delivery room, were included in the sample exclusion criteria: * women with a risky pregnancy diagnosis (such as preeclampsia, placenta previa, gestational diabetes) * obstetric complications in labor (such as fetal distress, bleeding) * visual and hearing problems * any pharmacological pain-reducing method applied, were excluded from the study

Keywords: primiparous birth pain birth satisfaction virtual reality midwifery
dexmedetomidine and fentanyl versus midazolam and remifentanil for sedation in patients undergoing ablation procedures

Conditions: Tachyarrhythmia

Summary: to evaluate the safety and efficacy of dexmedetomidine and compare this to a current technique commonly used at tgh for sedation in patients undergoing ablation procedures for atrial fibrillation (af) and atrial flutter. the investigators hypothesise that dexmedetomidine will be at least equivalent to, or more so, in terms of effectiveness and safety, when compared to midazolam and remifentanil for sedation during ablation procedures.

the role of ablation for chronic persistent af has been debated amongst cardiologists for some time, and there is increasing evidence that ablation may be superior to medical management. as populations age, the rate of af is likely to increase and therefore the numbers of ablations performed for this arrhythmia will also be expected to increase. ablation procedures can vary in length from one to more than 6 hours in duration and require the patient to keep still so as not to influence the mapping procedure. options for anaesthesia care include a general anaesthetic or sedation. several studies have evaluated the safety of sedation for ablation, using combinations of fentanyl, midazolam and propofol. these demonstrate that the ablation procedures are well tolerated under deep sedation. dexmedetomidine is an attractive potential agent for this role due to its favourable respiratory pharmacodynamics and good sedation profile. dexmedetomidine is a short acting relatively specific alpha-2 receptor agonist (alpha 2: alpha 1 = 1300:1). it has been shown to have very little effect on respiratory parameters, even at high doses.in addition, it may offer some analgesic properties and therefore minimise the need for narcotic based agents. the investigators will compare dexmedetomidine infusion and fentanyl bolus with remifentanil infusion midazolam bolus.

Eligibility criteria:
inclusion criteria: * patients listed for an ablation procedure for treatment of atrial fibrillation or flutter at tgh requiring sedation provided by an anesthetist * valid consent exclusion criteria: * baseline hr \<40 * baseline sbp \< 80mmhg * baseline sbp \> 180mmhg * second or third degree heart block unless pacemaker in situ * uncontrolled heart failure/severe lv dysfunction (ejection fraction \< 40%) * severe hepatic dysfunction (transaminases greater than 2 times the upper limit of normal) * renal dysfunction: estimated gfr \< 30ml/min, or requiring dialysis * allergy to any of the study drugs (dexmedetomidine, remifentanil, fentanyl, midazolam) * cognitive impairment precluding ability to tolerate sedation and comply with assessment methods * requirement for general anaesthetic for the procedure * pregnancy or breast feeding mothers * chronic use or addiction to opioids * \< 18 years of age

Keywords: sedation, analgesia
single dose clinical trial of mg-zg122 in chinese healthy adult subjects

Conditions: Asthma

Summary: to determine the safety and tolerability of mg-zg122 in chinese healthy adult subjects

main purpose: to determine the safety and tolerability of mg-zg122 humanized monoclonal antibody injection (mg-zg122 for short) in chinese healthy adult subjects. secondary objective: to study the pharmacokinetic (pk) characteristics of mg-zg122 in healthy chinese adult volunteers, and to provide a basis for the design of clinical trial protocols for subsequent clinical trials; to evaluate the immunogenicity of mg-zg122 in chinese healthy adult volunteers; preliminary exploration of the efficacy of mg-zg122 in chinese healthy adult subjects impact of biomarkers in physiology (pd).

Eligibility criteria:
inclusion criteria: - 1. the subjects signed the icf before the study and fully understood the research content, process and possible adverse reactions; voluntarily participated in the study and were able to complete the study according to the program requirements. 2. chinese healthy adult subjects aged 18-65 years (including the boundary value) , both male and female; 3. male volunteers weighing ≥50 kg; women weighing ≥40 kg; body mass index (bmi) within the range of 19.0-26.0 kg/m2 (including boundary values; bmi=weight kg/height 2 m2); exclusion criteria: 1. patients with acute or subacute infection (such as fever, cough, urgency, dysuria, abdominal pain, diarrhea and skin infection wounds, etc.) within 2 weeks before screening, or acute or chronic infection within 4 weeks before screening history, and receiving systemic anti-infective treatment; 2. those who have a history of tuberculosis infection in the past; 3. the results of physical examination, vital sign measurement, laboratory examination, electrocardiogram, chest x-ray, etc. are abnormal and have clinical significance; 4. those who are known to be allergic to monoclonal antibody drugs or excipients of mg-zg122 injection, or food allergies judged by the investigator to be unsuitable to participate in the researcher; 5. those who have been vaccinated within 1 month before screening or plan to be vaccinated during the study; 6. those who have used any prescription drugs within 2 weeks before administration, those who have used non-prescription drugs or traditional chinese medicines within 1 week before administration, or those who are expected to use prescription drugs, non-prescription drugs and traditional chinese medicines during the study period; 7. those who have received any research non-biological agents within 5 half-lives (if known) or within 3 months (whichever is longer) before administration, or have participated in other clinical trials or plan to participate in other clinical trials during the study period. clinical trial subjects; 8. those who have special requirements for diet or cannot accept a unified diet; 9. women who are lactating and pregnant, or female volunteers of childbearing age have a positive serum pregnancy test;

Keywords: asthma
chemotherapy for patients with advanced solid tumors or non-hodgkin's lymphoma

Conditions: Solid Malignancies; Non-Hodgkin's Lymphoma

Summary: the purposes of this study are to determine: * the largest dose of aq4n that can be safely given once a week for three weeks out of a 4 week cycle * the side effects of aq4n when given on the above schedule * how much aq4n is in the blood and urine at specific times after administration and how the body get rids of aq4n * if aq4n helps treat cancer

this study is for people who have advanced cancer for which standard chemotherapy did not work or for which there are no reliably, effective treatments. aq4n is an experimental chemotherapy that is thought to target tumor areas with low oxygen content and low blood supply; tumor areas that are usually the most resistant to standard chemotherapy and radiation treatment. aq4n may be beneficial in cancer treatment by interfering with a protein that is required for cells to grow and divide, causing tumors to die or to delay their growth. all patients in this study will receive aq4n. the dose will be increased for each new patient or group of patients until the maximum tolerated dose is reached.

Eligibility criteria:
inclusion criteria: * advanced solid malignancy or non-hodgkin's lymphoma that is refractory to treatment or has recurred * age \> 18 years * adequate hematologic (blood), kidney and liver function * negative pregnancy test (females of childbearing potential only) * willingness to use effective contraception by both males and females throughout the treatment period and for at least 2 months following treatment. exclusion criteria: * any chemotherapy or radiation within the past 4 weeks * symptomatic or uncontrolled brain metastases (patients with history of brain metastases who have had repeat brain scans within the past 30 days that demonstrate no evidence of tumor progression or brain swelling and who do not require corticosteriod treatment may be eligible) * significant cardiovascular illness including, but not limited to, the following: active infection, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, heart attack within the past six months, or uncontrolled, irregular heart beat * inadequate cardiac function * prior investigational therapy within the past 28 days * pregnant or breast feeding women

Keywords: diffuse follicular chronic lymphocytic leukemia colorectal cancer pancreatic cancer acute myelogenous leukemia head and neck cancer breast cancer prostate cancer ovarian cancer bladder cancer hypoxia refractory metastatic