Kornimate/medical-research-clean huggingface dataset:
association between genetic variant scores and p2y12 inhibitor effects

Conditions: Stent Thrombosis; Ischemic Stroke; Myocardial Infarction; Acute Coronary Syndrome

Summary: the goal of this study is to predict and prevent adverse drug events by investigating the impact of genetic variants, demographics, and environmental factors in subjects status post myocardial infarction and percutaneous coronary insertion who have experienced adverse drug events while on p2y12 inhibitors.

the goal of this study it to validate cipherome's drug safety score (dss) in its predictive accuracy for severe adverse drug reactions (adrs). the dss is calculated on a scale of 0 to 1, with preliminary studies demonstrating that scores below 0.3 correlated with a higher chance of an adr and scores above 0.7 correlated with a lower chance of an adr.

Eligibility criteria:
inclusion criteria: 1. patients 18 years and older, who are on p2y12 inhibitors (clopidogrel, prasugrel, or ticagrelor). 2. ability to provide informed consent. exclusion criteria: 1. lack of informed consent
clinical safety for the inspiratory muscle training

Conditions: Heart Diseases; Lung Disease

Summary: the aim of this study is evaluate the clinical, hemodynamic and electrocardiographic responses during an inspiratory muscle training session during a single cardiopulmonary rehabilitation session program. an electrocardiogram will be continuously recorded and the heart rate (hr) and blood pressure (bp) will be evaluated before, during and immediately after a single inspiratory muscle training (imt) session, consisting of two series of 15 cycles, with one-minute intervals between sets and an initial load of at least 30% of the initial maximal inspiratory pressure (mip).


Eligibility criteria:
inclusion criteria: * patients regularly attending a supervised exercise program * patients were already performing the imt in their usual supervisioned exercise sessions exclusion criteria: * cognitive impairment

Keywords: blood pressure heart rate electrocardiogram cardiac arrhythmias respiratory exercise
a randomized, double-blind, placebo controlled study of l-leucovorin in combination with trimethoprim / sulfamethoxazole in the therapy of pneumocystis carinii pneumonia in patients with the acquired immunodeficiency syndrome

Conditions: Pneumonia, Pneumocystis Carinii; HIV Infections

Summary: the primary objective of the study is to evaluate the effectiveness of l-leucovorin in preventing toxicity from high dose trimethoprim / sulfamethoxazole (tmp / smx) used as a therapy for pneumocystis carinii pneumonia (pcp) in patients with aids.


Eligibility criteria:
inclusion criteria patients must have the following: * diagnosis of pcp. * fit the cdc definition of aids. * be receiving intravenous or oral trimethoprim / sulfamethoxazole (bactrim, septra) in doses of = or \> 15mg/kg/day of the trimethoprim component. * be receiving = or \< 48 hours of trimethoprim / sulfamethoxazole (tmp / smx) prior to randomization. * must sign informed consent in accordance with fda guidelines. exclusion criteria co-existing condition: patients with the following conditions or symptoms are excluded: * cannot take oral medications. * require continued administration of anticonvulsant agents such as phenytoin, phenobarbital or primidone. concurrent medication: excluded: * continued administration of anticonvulsant agents such as phenytoin, phenobarbital or primidone. patients with the following are excluded: * cannot take oral medications. * require continued administration of anticonvulsant agents such as phenytoin, phenobarbital or primidone. prior medication: excluded: * \> 48 hours of trimethoprim / sulfamethoxazole prior to randomization.

Keywords: trimethoprim-sulfamethoxazole combination aids-related opportunistic infections pneumonia, pneumocystis carinii acquired immunodeficiency syndrome
the genetic basis for atrial fibrillation

Conditions: Atrial Fibrillation

Summary: atrial fibrillation (af) is reaching epidemic proportions in the aging u.s. and european populations, but the mechanisms of increased susceptibility to atrial fibrillation are still unknown. in this study, we look to further examine genetic and medical co-morbidity influence of atrial fibrillation duration and response to medications. in specific aim 1, we propose the creation of a veterans affairs af biorepository (vaafbio), which is a resource that will collect and store clinical, demographic, blood and dna samples from patients with atrial fibrillation to aide this study and future studies of this type in the va population. in specific aim 2, examine common genetic polymorphisms in veteran patients with atrial fibrillation and examine gene-environment interactions with risk factors for atrial fibrillation.

atrial fibrillation (af) is reaching epidemic proportions in the aging u.s. and european populations, but the mechanisms of increased susceptibility to atrial fibrillation are still unknown. in this study, the investigators look to further examine genetic and medical co-morbidity influence of atrial fibrillation duration and response to medications. in specific aim 1, the investigators propose the creation of a veterans affairs af biorepository (vaafbio), which is a resource that will collect and store clinical, demographic, blood and dna samples from patients with atrial fibrillation to aide this study and future studies of this type in the va population. in specific aim 2, the investigators will examine common genetic polymorphisms in veteran patients with atrial fibrillation and examine gene-environment interactions with risk factors for atrial fibrillation. patients will be identified through the va inpatient and outpatient clinic, and will be approached for inclusion in the study. the target enrollment for the research and biorepository is 600 participants. a detailed family history, medical background, study questionnaires and a blood sample will then be obtained by the principal investigator or a research coordinator, following written informed consent under a protocol approved by the jesse brown va institutional review board. once enough samples are collected, coded dna samples will be sent out to analyze for linkage to known/candidate loci for af.

Eligibility criteria:
inclusion criteria: * subjects must be at least 18 years of age, and up to 100. * subjects must have a documented history of atrial fibrillation by ecg, echo, and or holter monitor event recorder. * subjects must be willing to give written, informed consent. exclusion criteria: * patients with a history of af or atrial flutter that is only associated with cardiac surgery will be excluded from the study. * subjects who cannot speak english will be excluded from the study.
effects of spirulina supplementation on mental health in healthy adults

Conditions: Depression; Mental Acuity

Summary: spirulina platensis is a form of cyanobacteria, a blue-green algae, and is a superfood most known for being rich in protein, vitamins and minerals, and healthful phytochemicals. spirulina supports brain health through neuroprotection offered by its antioxidants, anti-inflammatory properties, and hormone regulation. the aim of this study is to supplement healthy adults from a campus community with 3g of spirulina, daily, for 8 weeks to improve mood and mental acuity in comparison to receiving a placebo.

spirulina is nutrient-dense with vitamins and minerals which provide antioxidants and anti-inflammatory mechanisms to help reduce oxidative stress and ros activity. preclinical studies have indicated spirulina can reduce inflammatory cytokines, such as il-1β, and reverse stress responses and oxidative damage in bdnf, nuclear factor erythroid 2-related factor (nrf2), and ultimately the phosphorylation of protein-kinase b (akt), which promotes cell growth. in addition to these benefits, fatty acids, gamma-linolenic acid (gla) and glycolipids, support gut health and the immune system. in combination, all these nutrients help increase neuroprotection and brain health. it is evident that spirulina supports brain health through neuroprotection, antioxidants, anti-inflammatory properties, and hormone regulation. research supports spirulina reversing neurodegenerative diseases due to several of these beneficial properties. there have been many studies that utilize spirulina to improve cognitive function in alzheimer's disease, parkinson's disease, ulcerative colitis, ibd, fibromyalgia and even in tbi and ischemic stroke. although many of these diseases have depressive symptoms, few of these studies have evaluated the impact of spirulina on mood. furthermore, no studies have been conducted relating depression and the cyanobacteria. it is possible that spirulina supplements can be used to reduce feelings of hopelessness and lack of energy, by providing additional vitamins, minerals, amino acids, and fatty acids, on a daily basis. this study aims to compare spirulina and its improvement on mood, in health college students, by daily supplementation of 3g of spirulina over a span of 8 weeks.

Eligibility criteria:
inclusion criteria: healthy adults ages 18-65 with no underlying chronic disease or acute conditions, no autoimmune conditions, and who do not consume alcohol in excess, smoke, use recreational drugs or follow restrictive diets, will be recruited from the asu university campus. exclusion criteria: participants will not have been clinically diagnosed with depression or take any antidepressants, anxiety, or stress medications, or any other medications, drugs, or supplements that could influence mental capacities. volunteers are excluded if pregnant or breastfeeding because there is not enough data to confirm the safety of spirulina in pregnant or breastfeeding women. competitive athletes will also be excluded. -

Keywords: spirulina depression mental acuity
post market clinical follow-up study protocol for profemur® l revision femoral stems

Conditions: Joint Disease

Summary: microport orthopedics (mpo) is conducting this pmcf study to evaluate the safety and efficacy of its tha and resurfacing components marketed in the eu. these types of studies are required by regulatory authorities for all tha and resurfacing devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the eu. this study has been designed in accordance with meddev 2.12/2 rev 2.


Eligibility criteria:
inclusion criteria: * has undergone revision total hip arthroplasty * subject is implanted with the specified combination of components * subject is willing and able to complete required study visits or assessments exclusion criteria: * subjects currently enrolled in another clinical study * subjects unwilling to sign the informed consent document * subjects with substance abuse issues * subjects who are incarcerated or have pending incarceration

Keywords: osteoarthritis avascular necrosis ankylosis protrusio acetabuli painful hip dysplasia rheumatoid arthritis correction of functional deformity revision procedures
a long-term study to evaluate safety and maintenance of treatment effect of ly3074828 in participants with moderate-to-severe plaque psoriasis (oasis-3)

Conditions: Psoriasis

Summary: the purpose of this study is to evaluate the long-term safety and maintenance of efficacy of mirikizumab in participants with moderate-to-severe plaque psoriasis.


Eligibility criteria:
inclusion criteria: * participant must have completed the last visit of an eligible study period of originating study. * participant must be willing to follow the birth control measures during and after study treatment if woman of childbearing potential. exclusion criteria: * participant must not have an unstable or uncontrolled illness, including but not limited to a cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurologic disease or abnormal lab results, that the study investigator thinks makes it unsafe or inappropriate for the participant to participate in this study. * participant must not have stopped taking mirikizumab during a previous study or if the study investigator thinks restarting mirikizumab would create an unacceptable risk to the participant.

Keywords: il-23 interleukin-23 psoriasis
evaluation of delefilcon a contact lenses

Conditions: Refractive Errors; Myopia

Summary: the purpose of the study is to evaluate the lens fit characteristics of delefilcon a contact lenses with different base curves and diameters.

subjects will be expected to attend 4 office visits for an individual duration of participation of approximately 3 days.

Eligibility criteria:
key inclusion criteria: * successful wearer of spherical soft contact lenses in both eyes for a minimum of 5 days per week and a minimum of 6 hours per day during the past 3 months; * able to wear contact lenses within a range of sphere powers from -2.00 and -4.00 diopters (d); * best corrected visual acuity (bcva) (with manifest refraction) better than or equal to 0.10 logarithm minimum angle of resolution (logmar ) in each eye. key exclusion criteria: * any anterior segment infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator; * history of refractive surgery or plan to have refractive surgery during the study, or irregular cornea in either eye; * biomicroscopy findings at screening that are moderate (grade 3) or higher and/or corneal vascularization that is mild (grade 2) or higher; presence of corneal infiltrates. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: contact lenses
timing of meal insulin boluses for optimal postprandial glycemic control in type 1 diabetes

Conditions: Type 1 Diabetes

Summary: blood glucose levels in patients with type 1 diabetes tend to peak after eating a meal due to the delayed action of insulin when compared to carbohydrate absorption from food. it is the hypothesis of the investigator that administering the insulin for a meal 20 minutes before the meal will result in lower blood glucose peaks compared to administration of insulin immediately before or 20 minutes after starting to eat. all subjects will eat the same meal on three different occasions. insulin will be administered at one of the three times at each visit.

subjects enrolled in this study will be between the ages of 12 and 30 years inclusive. all subjects will be on an insulin pump and use carbohydrate counting as their method for insulin dosing at a meal. subjects in this study will complete three study visits lasting from approximately 8:30am until 1:30pm. at each visit, the subject will eat the same frozen breakfast meal. subjects will be supplied with the same insulin to maintain consistency between visits and between subjects. insulin will be administered at different times, depending upon the randomization group assigned to the participant. the three different times the insulin will be given is either 20 minutes before the meal, immediately before the meal and 20 minutes after the meal. all subjects will complete all three insulin bolus times. blood glucose will be measured by fingerstick every 30 minutes until the completion of the visit.

Eligibility criteria:
inclusion criteria: * 12 to 30 years of age, inclusive * clinical diagnosis of t1d and using daily insulin therapy for at least 1 year * using carbohydrate counting to dose meal time insulin * hba1c value upon enrollment greater than 6.0% and less than 12.0% * using csii therapy for diabetes management for at least three months * able and willing to give informed consent/assent to participate * no expectation that the subject will be moving out of the area of the clinical center during the study * willing to consume the same standard frozen meal on all three visits exclusion criteria: * the presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of the cgms sensors or the completion of any aspect of the protocol * being unable or unwilling to give informed consent * having documented hypoglycemia unawareness * an episode of severe hypoglycemia (seizure or loss of consciousness) or of ketoacidosis in the past six months

Keywords: blood glucose meal insulin
a study to assess patient-reported quality of life and effectiveness on control of bleeding in adult participants with heavy menstrual bleeding due to uterine fibroids taking oral oriahnn capsules

Conditions: Heavy Menstrual Bleeding; Uterine Fibroids

Summary: uterine fibroids (uf) are noncancerous (benign) tumors that commonly occur in up to 80% of women of reproductive age. symptoms can include heavy menstrual bleeding (hmb), low back pain, urinary frequency and urgency, gastrointestinal symptoms, and fatigue. in participants with uf, this study will prospectively assess changes in patient-reported quality of life and patient-reported effectiveness in controlling hmb when treated with elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules (elagolix + e2/neta). around 200 adult premenopausal female participants in the united states with a diagnosis of hmb associated with uf and are prescribed elagolix + e2/neta by their physicians as per standard of care will be enrolled in this direct-to-patient observational study for up to 6 months. participants will have been prescribed elagolix + e2/neta within the last 30 days prior to enrollment and will continue to take elagolix + e2/neta throughout study participation. there may be a higher burden for participants in this study compared to standard of care. electronic patient reported outcomes (epros) will be collected at baseline, 1, 3 and 6 months to assess the impact of elagolix + e2/neta on patient-reported quality of life.


Eligibility criteria:
inclusion criteria: * participants who have initiated elagolix + estradiol/norethindrone acetate (e2/neta) in the last 30 days or less, or with planned initiation of elagolix + e2/neta prescribed as part of standard of care treatment. * participants self-reporting heavy menstrual bleeding (hmb) associated with uterine fibroids (uf). * participants are premenopausal (i.e., still report experiencing menses). exclusion criteria: * participants that report they are pregnant or planning to become pregnant in next 6 months. * participants reporting a surgical history of: * hysterectomy (with or without oophorectomy). * bilateral oophorectomy. * participants who have initiated elagolix + e2/neta more than 30 days ago.

Keywords: elagolix estradiol/norethindrone acetate (e2/neta) oriahnn abt-620 heavy menstrual bleeding (hmb) uterine fibroids (uf)
prehabilitation for breast cancer surgery

Conditions: Breast Cancer

Summary: prehabilitation for women diagnosed with breast cancer is commonly not part of the clinical pathways as little time (usually a few days) is left between diagnosis and surgery. however, a great proportion of these patients will undergo neoadjuvant chemotherapy which provides a window opportunity to improve patients' physical status to withstand surgery and minimize post-operative musculoskeletal complications associated with surgery. to this end, the aim of this study is to assess the efficacy of a prehabilitation program consisting of health education and a supervised nordic walking-based intervention in women diagnosed with breast cancer currently undergoing neoadjuvant chemotherapy to decrease post-operative musculoskeletal impairments and improve functionality of the affected arm. the study is an open-label, single-blind randomised controlled trial conducted at one tertiary hospital. women diagnosed with breast cancer scheduled for surgery and currently undergoing chemotherapy will be randomised to either usual care (uc) or prehabilitation (prehab). patients will be assessed for eligibility during the fourth out of six course of chemotherapy. those randomised to the prehab group will participate in a supervised group-based nordic walking intervention twice weekly during 8 weeks (approximately 16 sessions). in addition, participants will receive written information regarding the benefits of exercise during cancer treatment and surveillance. patients will be assessed prior to surgery as well as at 1, 3 and 6 months postoperatively.


Eligibility criteria:
inclusion criteria: * diagnosis of breast cancer scheduled for surgery with or without lymphadenectomy * candidates to receive neoadjuvant chemotherapy * not currently undergoing any other physical therapy therapies or treatments exclusion criteria: * cognitive impairment or inability to read catalan or spanish * prior diagnosis of shoulder impairment or injury * major musculoskeletal, neurological or cardiorespiratory limitations to prevent participation in the exercise program

Keywords: breast cancer prehabilitation exercise therapy
a viveve experience normalizes untreated selective serotonin reuptake inhibitor (ssri) sexuality syndrome

Conditions: Sexual Dysfunction

Summary: a pilot study to investigate non-surgical treatment for women who suffer from sexual complaints secondary to ssri sexuality syndrome.


Eligibility criteria:
inclusion criteria: * currently using ssri for 3 months at a stable dose exclusion criteria: * pregnant, currently breastfeeding, or breast-fed within the last 6 months * has any implantable electrical device that could potentially be affected by use of radiofrequency.
efficacy and safety of low dose thalidomide in transfusion dependent thalassemia

Conditions: Thalassemia

Summary: thalidomide is known to have hypnosedative, immuno-modulatory and anti-angiogenic effects. the drug is widely used in several neoplastic disorders (e.g. multiple myeloma and malignant melanoma), inflammatory conditions (e.g. crohn's disease) and skin disorders (e.g. leprosy). thalidomide has been successfully used in adult thalassemia patients. the current study explores its role in transfusion-dependent thalassemia patients.


Eligibility criteria:
inclusion criteria: * transfusion dependent thalassemia patients refractory to hydroxyurea exclusion criteria: * those with active systemic comorbidity, with past personal or family history of thrombophilia, recent fracture or recent major surgery

Keywords: thalidomide thalassemia