Kornimate/medical-research-clean huggingface dataset:
a trial of amxi-5001 for treatment in patients with advanced malignancies

Conditions: Advanced Malignant Neoplasm; Breast Cancer; Ovarian Cancer; Homologous Recombination Deficiency; Prostate Cancer; Pancreatic Cancer

Summary: atlas-101 is a phase i/ii clinical trial of amxi-5001 in adult participants with advanced malignancies who have previously failed other therapies. the study has two phases. the purpose of phase i (dose escalation) is to confirm the appropriate treatment dose and phase ii (dose expansion) is to characterize the safety and efficacy of amxi-5001.

amxi-5001 is an orally available dual parp (poly adenosine diphosphate \[adp\] ribose polymerase) and microtubule polymerization inhibitor. atlas-101 is a phase i/ii, open label, multi-center, non-randomized dose escalation and dose expansion study in participants with advanced malignancies. study enrollment is approximately 122 participants. all participants receive oral amxi-5001, twice daily, as monotherapy. following phase i (dose escalation) to identify the maximum tolerated dose and the recommended dose for use in phase ii, additional participants will be enrolled into the dose expansion phase to further characterize the safety, pharmacology, and clinical efficacy of amxi-5001.

Eligibility criteria:
inclusion criteria (key factors): 1. has pathologically confirmed advanced or metastatic malignancy characterized by one or more of the following: 1. patient is intolerant of existing therapy(ies) known to provide clinical benefit for their condition 2. malignancy is refractory to existing therapy(ies) known to potentially provide clinical benefit 3. malignancy has progressed after standard therapy 2. has evaluable or measurable tumor(s) in dose escalation by standard radiological and/or laboratory assessments as applicable to their malignancy. 3. eastern co-operative oncology group (ecog) ps 0-1 4. participant must be 18 years of age or older 5. able to understand and sign consent exclusion criteria (key factors): 1. receiving cancer treatment at the time of enrollment 2. any clinically significant disease or condition affecting a major organ system 3. significant cardiovascular disease or electrocardiogram (ecg) abnormalities 4. use of a strong inhibitor or inducer of cyp3a4 within 7 days prior to start of study therapy and throughout the study (e.g., some antibiotics, antifungals, anticonvulsants, grapefruit) 5. has had a previous (within 2 years) or has a current malignancy other than the target cancer

Keywords: breast ovarian prostate pancreatic refractory cancer malignancy brca hrd amxi-5001 progression parp inhibitor microtubule inhibitor
medi7183 phase 2 study in japanese ulcerative colitis patients

Conditions: Ulcerative Colitis

Summary: this is a multi-centre, randomised, double-blind, placebo controlled, parallel group, phase ii study to evaluate efficacy and safety of 3 doses of medi7183, in japanese subjects with moderate to severe uc


Eligibility criteria:
inclusion criteria: * provision of informed consent prior to any study specific procedures * diagnosis of uc established by clinical and endoscopic evidence and corroborated by a histopathology report * moderate to severe active uc as defined by a total mayo score of 6 to 12 with rectosigmoidoscopy score ≥ 2 during screening period * demonstrated an inadequate response to, loss of response to, or intolerance to at least one of immunomodulators or anti- tnf-α agents. etc. exclusion criteria: * disease limited to the rectum * toxic megacolon * crohn's disease * history of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, koch pouch, or ileostomy for uc * planned bowel surgery within 12 weeks from visit 2 * stool positive for c. difficile toxin at screening * primary sclerosing cholangitis * history of gastrointestinal surgery within 8 weeks of visit 2 * any uncontrolled or clinically significant systemic disease * condition or disease that, in the opinion of the investigator would pose a risk to subject safety or interfere with study evaluation, procedures or completion * subjects with positive hbsag, hbsab, hbcab or hcvab serology at screening etc

Keywords: ulcerative colitis, japanese, subcutaneously
intelligent oxygen therapy during sleep

Conditions: Respiration Failure

Summary: long-term oxygen therapy improves survival in patients with severe hypoxia. however, some patients despite this oxygen, experience episodes of low oxygen levels (intermittent hypoxia) especially during sleep which may be harmful. in order to overcome this, the investigators have designed an auto-titrating oxygen system (called intelligent oxygen therapy) which automatically adjusts oxygen flow rates to maintain oxygen levels in patients already on oxygen. this study will investigate whether the intelligent oxygen therapy system can prevent intermittent hypoxia during sleep in patients already on long-term oxygen.

long-term oxygen therapy (ltot) improves survival in patients with chronic obstructive pulmonary disease (copd) and severe persistent hypoxia. ltot is prescribed at a fixed-flow rate with the aim of maintaining a partial pressure of oxygen greater than or equal to 8 kilopascals (kpa). however, a number of studies have demonstrated that patients on home ltot experience episodes of intermittent hypoxia during rest, activities and especially sleep. simply increasing the oxygen flow rate at night can relieve this hypoxia but at the expense of hyperoxia with its detrimental effects of hypercapnia and respiratory acidosis. therefore, a more targeted approach is needed to oxygen delivery. the investigators have devised an auto-titrating oxygen system (intelligent oxygen therapy \[io2ts\]) which delivers variable flow oxygen to maintain a pre-set specific oxygen saturation ( spo2) target. the system can avoid the dual hazards of hypoxia and hyperoxia and potentially optimise ltot. this study will be investigating whether the io2ts can reduce intermittent hypoxia during sleep compared to usual fixed flow oxygen in patients on ltot. nineteen patients will be recruited to undergo two sleep studies each on two different nights; one on their usual ltot flow rate and one of the io2ts. during both sleep studies, all participants will have full polysomnography, oxygen and transcutaneous carbon dioxide monitoring. the primary outcome will the percentage of time spent with spo2 \< 90% during sleep.

Eligibility criteria:
inclusion criteria: * on or eligible for long-term oxygen therapy exclusion criteria: 1. nocturnal use of non-invasive ventilation (niv) or continuous positive airways pressure (cpap) 2. a diagnosis of obstructive sleep apnoea 3. a diagnosis of a neuromuscular disease 4. daytime partial pressure of carbon dioxide \> 8.0 kpa 5. inability to consent for the study 6. exacerbation of the underlying lung disease or chest infection in the previous 4 weeks 7. pregnancy 8. severe co-morbidities 9. patients with a tracheostomy 10. long-term oxygen therapy flow rate ≥ 4 litre per minute 11. inability to understand the english language

Keywords: long-term oxygen therapy intelligent oxygen therapy system auto-titrating oxygen system
effect of omega-3 fatty acid supplementation on dry-amd progression

Conditions: Age-Related Macular Degeneration

Summary: this multi-center, randomized, double-blind (subjects and doctors), placebo controlled study will evaluate the effect of krill oil on dry-amd progression. the pilot study will observe biochemical and hematologic biomarkers changes after 3-month treatment between the krill oil group and placebo group


Eligibility criteria:
inclusion criteria: * dry-amd patients in either early, intermediate, or intermediate-to-late stage confirmed by fundus photography and ffa. * willing to stop supplementation of omega-3 fatty acids, choline, or astaxanthin. * willing to sign the informed consent, and willing to attend follow-up visits for at least 5 years. exclusion criteria: * any eye with disease that would interfere with the fundus examinations * eye with cnv, ga or high myopia * surgeries that may interfere with amd evaluation * long-term use of any medications that are associated with retinal or neural toxicities. * supplementation history with more than 2 mg lutein or 500 mg omega-3 fatty acid/day s (can be included if wash-out phase for 8 weeks before the trial) * omega-3 index \> 6 * intraocular pressure more than 26 mmhg * received cataract surgery in 3 months. * other conditions: diseases that causes less than 5 years survival; any condition that causes high risk of drop-out, or low compliance, for instance cognition disorder; have been involved in other trial that interfere with the current visit plan; taking other angiogenesis inhibitors drugs for treating cancer. * other conditions not suitable for the current study

Keywords: dry age-related macular degeneration krill oil
telerehabilitation in individuals temporomandibular dysfunction with bruxism

Conditions: Myofascial Pain; Temporomandibular Disorder; Bruxism

Summary: the aim of the study is to compare the effects of home exercise therapy (het) and telerehabilitation in patients with myofascial temporomandibular disorders (tmd)with bruxism.

home exercise will be group 1 and telerehabilitation group will be group 2. group 1 het, will include an educational training program about parafunctional activities of tmd disorders and bruxism and active exercises for 4 weeks. as part of the home exercise program, a written document will be prepared, including relaxation, breathing training, posture, stretching, and strengthening exercises to be given to the patients. group 2, in addition to the training and written document, the second group will receive the same exercises using telerehabilitation once a week by video call, and reminder messages will be sent to the patients 3 times a week.

Eligibility criteria:
inclusion criteria: * ages between 18 and 65 years old * patients with tmd in the myofascial group ia, ib according to the research diagnostic criteria for temporomandibular disorders (rdc/tmd) and diagnosed with bruxism * having pain ≥ 3 according to the visual analog scale * those who have not received medical treatment for the last 3 months and will not receive it during the treatment process will be included in the study. exclusion criteria: * ages under 18 and over 65 years old * patients with disc displacement and/or tmj degeneration * patients who have orthodontic or splint treatment * patients with musculoskeletal problems in which systemic specific pathological conditions such as cervical and/or temporomandibular joint (tmj) problem malignancy, fracture, the rheumatoid disease is proven * patients who have undergone any surgery related to the cervical and/or tmj * patients with facial paralysis * patients who regularly use analgesic or anti-inflammatory drugs * patients who have received physical therapy associated with tmj in less than 3 months * patients with a history of trauma (whiplash injury, condylar trauma, fracture) * patients with cognitive deficits * participation rate lower than 80% of the program schedule

Keywords: myofascial pain temporomandibular disorder bruxism telerehabilitation
the learn study for cvd prevention

Conditions: Cardiovascular Diseases

Summary: the investigator is testing a virtual environment to address prevention of hiv-related comorbidities.

the primary aims of this study are to test the feasibility, acceptability and preliminary effects of a ve to address prevention of hiv-related comorbidities. a waitlist control feasibility clinical trial will be conducted. we will assign (n=80) eligible participants and ensure balanced allocation to intervention and control groups over the intervention period. we hypothesize that the ve will be feasible and acceptable to persons living with hiv, and that they will apply their ve learning to real-life situations and health behaviors for prevention of hiv-related comorbidities.

Eligibility criteria:
inclusion criteria: * identify as an ethnic/racial minority with hiv * identify as gay, same-gender-loving, or msm * able to read and understand english * access to a computer capable of downloading and running the ve software * no medical history of serious cardiovascular or cognitive complications exclusion criteria: anything outside of inclusion parameters, including history of: * myocardial infarction (mi) * congestive heart failure (chf) * coronary artery bypass graft (cabg) * cerebral vascular accident (cva) * cognitive impairment

Keywords: comorbidity cardiovascular diseases sexual and gender minorities hiv infections virtual reality cardiovascular health
study evaluating 13-valent pneumococcal conjugate vaccine catch-up regimens in older infants and children

Conditions: Pneumococcal Infections

Summary: the purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vpnc) in older infants and children who have not previously been immunized with pneumococcal vaccine.


Eligibility criteria:
inclusion criteria: 1. aged from 7 months to \<72 months at time of enrollment. 2. available for entire study period and whose parent/legal guardian could be reached by telephone. 3. healthy as determined by medical history, physical examination, and judgment of the investigator. 4. parent/legal guardian had to be able to complete all relevant study procedures during subject participation. exclusion criteria: 1. previous vaccination with licensed or investigational pneumococcal vaccine. 2. a previous anaphylactic reaction to any vaccine or vaccine-related component. 3. contraindication to vaccination with pneumococcal vaccine. 4. bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. 5. known or suspected immune deficiency or suppression. 6. history of culture-proven invasive disease caused by s pneumoniae. 7. major known congenital malformation or serious chronic disorders. 8. significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. does not include resolving syndromes due to birth trauma such as erb palsy. 9. receipt of blood products or gamma-globulin (including monoclonal antibodies) in the last 3 months. 10. participation in another investigational or interventional trial. participation in purely observational studies is acceptable. 11. child is a direct descendant (child or grandchild) of a member of the study site personnel.

Keywords: pneumococcal vaccines
a study of ly2922083 in healthy participants and participants with diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the aim of this trial is to evaluate the safety of the study drug in healthy participants and participants with diabetes. it will investigate how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. information about any side effects that may occur will also be collected. the study consists of two parts. part a will study healthy participants in up to 3 dosing periods over approximately 6 weeks. part b will study participants with diabetes in up to 3 dosing periods over approximately 6 weeks.


Eligibility criteria:
inclusion criteria: for all participants : * must be a male, or a female who cannot become pregnant, and who is either a healthy participant, or who has type 2 diabetes * have a screening body mass index (bmi) of at least 18.0 kilograms per square meter (kg/m\^2) * have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study for participants with t2dm: * do not have any change to their diabetes treatment (exercise with or without metformin) for at least 4 weeks prior to screening * have a glycated hemoglobin (hba1c) value of greater than or equal to 6% and less than or equal to 11% at screening exclusion criteria: for all participants : * are currently participating in another clinical study or completed one in the last 30 days * are allergic to ly2922083 or other related drugs * have a history of significant heart, lung, liver, kidney, stomach or brain disease, or have any medical problems which may cause an increased risk during the study * have electrocardiogram (ecg) readings that are not suitable for the study * have a history of hepatitis or jaundice * are infected with hepatitis b * are infected with hepatitis c * are infected with human immunodeficiency virus (hiv) * have donated more than 450 milliliters (ml) of blood in the last 3 months or have donated any blood in the last month * have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female), or are unwilling to stop alcohol as required by the study restrictions (1 unit = 360 ml of beer, or 150 ml of wine, or 45 ml of spirits) * smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic for participants with t2dm : * have had heart disease or stroke within 6 months before entering the study * have health complications due to poorly controlled diabetes as shown by blood and urine laboratory test results or based on physical examination and medical assessment as determined by the study doctor * have been hospitalized for poor control of diabetes (keto-acidotic episode) in the last 6 months * have used insulin to control diabetes in the last 1 year * show symptoms of high blood sugar (for example, frequent urination, always feeling thirsty, or unexpected weight loss)
sarcopenia and combined-modality exercise

Conditions: Sarcopenia

Summary: this study examined the effects of combined-modality exercise training (resistance, endurance, flexibility and balance) on muscle mass, muscle function and physical activity in community-dwelling elderly living in jamaica who had been characterised as having sarcopenia.

community-dwelling seniors aged 60 years and older were screened for muscle mass and function (grip strength and walk speed) and persons with sarcopenia were identified using the european working group on sarcopenia in older persons (ewgsop) algorithm for case finding (n=1344). of the 77 seniors with sarcopenia, 38 consented to participate and were randomly allocated to receive 6 months combined-modality high intensity treadmill based exercise and a 'usual care' home exercise programme. a comparison of the effects of treatment assignment on muscle mass, function, fitness, physical activity level and disability was done. participants in the supervised combined-modality high intensity group were required to attend sessions 3 times per week; participants in the home exercise programme were required to attend 1 supervised session at the start of their 6-month intervention. outcomes were assessed at baseline and at the end of the 6-month intervention. data were analysed using standard statistical parametric and non-parametric methods including repeated measures analysis of variance to determine changes in outcomes and regression to establish determinants of outcomes.

Eligibility criteria:
inclusion criteria: * over 60 years old, * independently ambulant, with or without an assistive device * mentally competent to give informed consent and follow exercise instructions exclusion criteria: * a history of stroke with residual disability * a diagnosis of cancer * neuromuscular disorders * auto-immune disorders * dementia * severe arthritis rendering participation in an exercise programme difficult * unstable cardiovascular disease which renders exercise unsafe

Keywords: exercise training
efficacy, safety and tolerability study of meloxicam injection in subjects after abdominal surgery

Conditions: Pain, Post-operative

Summary: the purpose of this study is to determine the analgesic efficacy and safety of meloxicam injection in subjects undergoing abdominal surgery.


Eligibility criteria:
inclusion criteria: voluntarily provide written informed consent. be scheduled to undergo elective abdominoplasty surgery without collateral procedures. be american society of anesthesiology (asa) physical class 1 or 2. male or female between 18 and 70 years of age, inclusive. have a body mass index 18\~30 kg/m2. be able to understand the study procedures, comply with all study procedures, and agree to participate in the study program. exclusion criteria: have a history of abdominoplasty surgery within the preceding 12 months. have active or recent (within 6 months) gastrointestinal ulceration or bleeding. have a history of myocardial infarction or coronary artery bypass graft surgery within the preceding 12 months. have a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study. have a history of migraine or frequent headaches, seizures, or are currently taking anticonvulsants. have another painful physical condition that may confound the assessments of post operative pain. have a history of advanced malignant tumor. have a history of alcohol abuse (regularly drinks \> 4 units of alcohol per day; 8 oz. beer, 3 oz. wine, 1 oz. spirits) within the past 5 years or a history of prescription/illicit drug abuse. have positive results on the urine drug screen or alcohol breath test indicative of illicit drug or alcohol abuse. have evidence of a clinically significant 12 lead ecg abnormality. have a clinically significant abnormal clinical laboratory test value. have history of or positive test results for hiv, treponema pallidum,or hepatitis b or c. have a known allergy to meloxicam or any excipient of n1539, d5w, aspirin, other non-steroidal anti-inflammatory drugs (nsaids) or to any peri- or postoperative medications used in this study. have been receiving or have received chronic opioid therapy defined as greater than 15 morphine equivalents units per day for greater than 3 out of 7 days per week over a one-month period within 12 months of surgery.