Kornimate/medical-research-clean huggingface dataset:
a first in human clinical trial to evaluate the safety and effectiveness of the streamline surgical system in patients with open-angle glaucoma

Conditions: Open Angle Glaucoma

Summary: a prospective, nonrandomized, open label study to evaluate the safety and iop lowering effectiveness of the streamline surgical system, in patients with mild-to-moderate open angle glaucoma undergoing cataract surgery.

a prospective, nonrandomized, open label study to evaluate the safety and iop lowering effectiveness of the streamline surgical system, a viscoelastic delivery device, in patients with mild-to-moderate open angle glaucoma undergoing cataract surgery. this is a 12 month study conducted outside the us. approximately 60 subjects will be enrolled.

Eligibility criteria:
inclusion criteria: 1. able to understand and execute written informed consent 2. males or female subjects at least 22 years of age. 3. subjects qualifying for cataract surgery 4. subjects diagnosed with mild to moderate open-angle glaucoma in at least one eye currently treated with 1-3 topical iop-lowering medications 5. subjects with diagnosis of open-angle glaucoma in at least one eye with an unmedicated iop of 21-36 mmhg exclusion criteria: 1. women of child-bearing potential 2. modified shaffer angle grade \< 2 3. patients with severe or advanced glaucoma 4. intraocular surgery within the last 6 months or laser surgery within the last 3 months 5. bcva worse than 20/80 in either eye 6. patients with a previous peripheral iridotomy. 7. ocular infection or inflammation within the last 6 months. 8. any medication that would be contraindicated for a glaucoma surgical procedure.

Keywords: open angle glaucoma, iop, viscoelastic
provigil (modafinil) study by taiwan biotech co.

Conditions: Narcolepsy; Cataplexy; Sleep Disorders; Hypersomnolence; Excessive Sleepiness

Summary: the primary objective is to evaluate the therapeutic effect of excessive daytime sleepiness associated with narcolepsy. both of the subjective and objective sleepiness of the patients were assessed in the experiment by repeat measures.


Eligibility criteria:
inclusion criteria: * polysomnographic findings of shortened sleep latency less than 5 minutes average of multiple sleep latency test, and two or more sorem should be fulfilled. * age of 12 y/o to 55 y/o. * the liver and kidney functions are within normal limits. * meeting the strict criteria of narcolepsy described above. * wash out any medications which might enhance wakefulness or affect nocturnal sleep two weeks prior to the experiments. * willingness to comply with the protocol and signed the written informed consent. exclusion criteria: * patients whose hypersomnia was caused by severely sleep deprived, phase delayed, or suspected long sleeper. * patients with concomitant neurological disorder and psychiatric disorders. * patients with sleep-related breathing disorders whose apnea/hypopnea index (ahi) was 5 pauses per hour above. * patients with restless leg syndrome \& periodic limbs movements whose index was more than 5 per hour. * patients who are pregnant or breast-feeding.
diet and hypertension management in african americans with chronic kidney disease

Conditions: Chronic Kidney Diseases; High Blood Pressure

Summary: the purpose of this study is to determine cultural and disease-related barriers and facilitators to following the dietary approaches to stop hypertension (dash) dietary pattern among black americans with moderate chronic kidney disease (ckd) and test the impact of a behavioral diet counseling intervention on dash diet adherence, blood pressure, and ckd-relevant outcomes.

excess cardiovascular disease (cvd) mortality among black americans with ckd is a significant us public health disparity. compared to their white counterparts, blacks develop ckd earlier in life and blacks with ckd are 3 times more likely to progress to kidney failure necessitating dialysis or kidney transplantation, and are 1.5 times more likely to die prematurely from cvd. hypertension, which is also more prevalent, more severe, and less often controlled in blacks with ckd compared to whites, is a leading cause of ckd and cvd, and a major contributor to the racial disparity in cvd mortality. thus, improving hypertension in blacks with ckd could have a profound positive impact on an important minority health issue. the dash diet lowers bp and reduces cvd risk in patients with hypertension and has a greater effect on bp in blacks compared to whites. however, the effect of the dash diet on bp in blacks with ckd has not been established. first, investigators will conduct a qualitative study to identify self-perceived barriers and facilitators of dash diet adherence among blacks with moderate ckd. then, investigators will conduct feasibility, acceptability, and preliminary efficacy testing of a disease-sensitive, culturally-appropriate diet counseling intervention on dash adherence and blood pressure in blacks with ckd. prior to the clinical trial portion of this project qualitative focus groups were held to identify self-perceived barriers and facilitators of dash diet adherence among african americans with ckd. three to 4 groups of 6-8 participants were asked semi-structured questions to determine self-perceived sociocultural barriers and facilitators of dash diet adherence and disease-specific factors that may influence their ability and willingness to follow a dash-style diet. the information in the rest of this record pertains to the clinical trial portion of the project.

Eligibility criteria:
inclusion criteria: * black race (self-identified) * ≥21 years old * ckd defined as an egfr of 30-59 ml/min/1.73m2 exclusion criteria: * history of kidney transplant * pregnant of breast-feeding * risk factors for hyperkalemia including insulin-dependent diabetes mellitus, diabetes with poor blood glucose control (a1c \>10), baseline serum potassium ≥4.8 mg/dl, and serum bicarbonate \<18 mg/dl * history of hypertension in the preceding 6 months defined as serum potassium greater than 5.1 mg/dl * risk for hypotension or severe hypertension (sbp \<120 or ≥180 or dbp ≥110 mmhg) * history of kidney transplant * lack of english language proficiency

Keywords: racial disparities hypertension diet kidney disease
effects of rtms on the anxiety state of older patients with gad

Conditions: Generalized Anxiety Disorder

Summary: the purpose of this study is to evaluate the effects of low-frequency repetitive transcranial magnetic stimulation on anxiety state in older patients with generalized anxiety disorder.

repetitive transcranial magnetic stimulation can alter nerve cell excitability, improve cerebral blood flow and metabolism, and is widely used in neuropsychiatric research. studies have shown its efficiency and safety in treating anxiety disorders, however the senior patient group has not been adequately validated. the purpose of this study is to evaluate the effects of low-frequency repetitive transcranial magnetic stimulation on anxiety state in older patients with generalized anxiety disorder.

Eligibility criteria:
inclusion criteria: * 1）age≥60 years, regardless of gender. * 2）meets the diagnostic criteria for generalized anxiety disorder in the diagnostic and statistical manual of mental disorders fifth edition (dsm-v) developed by the american psychiatric association. * 3）hama score≥14 and hamd-17 items score \<17. * 4）no adjustment in the type and dose of anti-anxiety medication in the 3 months prior to randomization. * 5）willing to participate and sign the informed consent. exclusion criteria: * 1）traumatic brain injury or other conditions affecting the brain, such encephalitis, brain tumors, or intracranial hypertension. * 2）previous history of epilepsy, family history of epilepsy or presence of seizure provoking factors or alcohol abuse. * 3）history of other psychiatric disorders such as current post-traumatic stress disorder, substance use disorder (within 6 months), bipolar disorder and obsessive-compulsive disorder. * 4）unstable mental state with impulses toward self-harm or suicide. * 5）presence of intracranial metal implant, cochlear implant, built-in pulse generator (such as cardiac pacemaker), etc. * 6）medical or surgical disorders that are severe or unstable. * 7）pregnancy or breastfeeding. * 8) those who are participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to enrollment. * 9) other conditions that the researchers think are not suitable for the project.

Keywords: repetitive transcranial magnetic stimulation generalized anxiety disorder
start: swiss taxotere alopecia prevention trial

Conditions: Neoplasms; Alopecia

Summary: primary objective: * rate of complete chemotherapy induced alopecia (who grade iii or iv, physician grading) secondary objective: * compliance to scalp cooling procedure * received number of cycles of chemotherapy in each subgroup * patient perception of scalp cooling procedure * side effects of scalp cooling systems


Eligibility criteria:
inclusion criteria: * any solid tumor malignancy receiving docetaxel (taxotere®) 1st line chemotherapy treatment with the exception of regimen containing concomitant anthracycline treatment; sequential anthracycline/docetaxel treatment is permitted. * performance status ecog \<= 2 * absence of alopecia at inclusion exclusion criteria: * chemotherapy regimen including concomitant anthracycline treatment * raynaud's disease or phenomenon * cold agglutinin disease * cryoglobulinemia * cryofibrinogenemia * scalp metastasis * pregnancy or lactation * preexisting alopecia of any grade; notably androgenetic alopecia
treatment efficacy of low fodmap versus low lactose diet in ibs patients

Conditions: IBS - Irritable Bowel Syndrome

Summary: a low fodmap diet (lfd) has become a standard treatment in irritable bowel syndrome (ibs) patients. compliant adherence to a lfd is challenging. the investigator looked at the effect of a lfd compared to a less restrictive low lactose diet (lld) in a randomized cross-over trial with ibs patients.

irritable bowel syndrome (ibs) is a chronic gastrointestinal disorder. it affects 10 - 20% of the adult population. pharmaceutical therapy as bulking agents, anticholinergics, antispasmodics, and antidiarrheals are mostly unsatisfactory and many gastroenterologists recommend therefore dietary management. most patients note that various foods elicit abdominal symptoms and therefore restrict their diet . the low fermentable oligosaccharide, disaccharide, monosaccharide and polyol (fodmap) diet has currently the greatest evidence for efficacy in ibs. the rationale behind the lfd is the exclusion of poorly absorbed short-chain carbohydrates which would create an osmotic load, drag fluid into the small intestine and would be fermented by the colonic microbiome, both leading to abdominal distention and increased luminal influx. fodmaps do not cause symptoms in healthy adults as they neither show these abnormalities in gut physiology nor suffer from visceral hypersensitivity . it is not known however whether change in symptoms is induced by a reduction in all fodmaps or simply a single component as for example lactose. if there is a lactase deficiency, as it is the case in 2-20% of central- / northern europeans, lactose cannot be hydrolysed and causes the above mentioned symptoms. many ibs patients avoid lactose, even though only few have a lactase deficiency. lactose intolerance but not lactase deficiency is more frequent in patients with ibs. the investigator wanted to examine if the demanding lfd is more effective than elimination of lactose alone. our study, comparing in detail the effects of low fodmap versus low lactose diet in ibs patients is a novelty, analysing a clinically highly relevant topic.

Eligibility criteria:
inclusion criteria: * functional bowel symptoms as defined by the rome iv criteria * subjective lactose intolerance exclusion criteria: * pharmacologic agents to alter symptoms (laxatives, antidiarrheal agents) * smoking * antibiotic therapy within the last 4 weeks * gastrointestinal diseases (celiac disease was excluded by negative serologic testing while on a gluten containing diet * any type of food allergy
supervised fitness program for adults with cerebral palsy

Conditions: Cerebral Palsy

Summary: the purpose of this study is to compare the effectiveness of 2 community intervention approaches to maintain community mobility and walking speed in adults with cerebral palsy who have previously completed an 8 week course of physical therapy.

the proposed study will address the lifelong need for fitness in adults with cerebral palsy compared to individuals provided with a home exercise program at the end of their individualized physical therapy, individuals in the fitness group will... primary hypothesis: 1. have higher pediatric evaluation of disability inventory computer adapted test (pedicat) scores at the +12 weeks post intervention visit 2. increase their pedicat scores across the study period, while the home fitness group will decrease performance on the pedicat. 3. complete the timed up and go (tug) more quickly at +12 weeks post intervention secondary hypothesis (study not powered for these variables): 4. walk further on the six minute walk test (6mwt) at the +12 weeks post intervention visit

Eligibility criteria:
inclusion criteria: * adults with cerebral palsy gross motor function classification system (gmfcs) level i, ii, or iii * completion of episode of physical therapy provided by the developmental disabilities program at sheltering arms within the one month prior to the baseline assessment * lives within the community in their own home or group housing exclusion criteria: * gmfcs level iv or v * unable to follow two-step directions * adults who have a medical or legal power of attorney who sign their health authorization
core competency model for corrections

Conditions: Knowledge, Attitudes, Practice

Summary: the overall goal of this project is to design, implement, and revise the core competency model for corrections (ccm-c), an evidence-based self-directed violence (sdv) prevention training program for correctional mental health providers in the north carolina department of adult corrections (dac). the proposed specific aims are: aim 1: to create the ccm-c training program. aim 2: to assess preliminary training effectiveness. aim 3: to gather training program quality improvement feedback from corrections stakeholders.

investigators will conduct a pilot feasibility and preliminary effectiveness evaluation of the core competency model for corrections (ccm-c; cramer et al., 2022). this training approach involves psycho-educational content, self-assessment tools, interactive exercises to address 10 clinical care and practitioner-focused skill sets for suicide and self-injury risk assessment and management. the protocol employs a waitlist control sequential cross-over design and mixed-method evaluation approach targeting 50-100 nc correctional behavioral health clinicians (bhcs). through an ongoing academic-community partnership, investigators will employ a corrections advisory panel (cap) to provide expert review of training. the cap will comprise six nc-dac bhcs and 4-6 external bhcs with experience in correctional behavioral health. two training groups will each provide three assessments via an online self-report evaluation battery gathering information regarding participant demographics; sdv prevention knowledge, attitudes, and perceived skills; incarceration-related attitudes; and perceived importance of and intention to use sdv prevention practices.

Eligibility criteria:
inclusion criteria: * behavioral health clinician (bhc) * 18 years of age or older * living in the u.s. * currently employed by the nc dac exclusion criteria: * decisional or cognitive impairments that preclude being able to consent to study participation * being a member of the study correctional advisory panel (cap)

Keywords: suicide prevention self-injury risk assessment attitudes competency mental health provider
safety, tolerability and drug- drug interaction study of ubrogepant with erenumab or galcanezumab in participants with migraine

Conditions: Migraine

Summary: this study will evaluate the potential for a pharmacokinetic (pk) interaction and provide safety and tolerability information when ubrogepant and erenumab or ubrogepant and galcanezumab are co-administered.


Eligibility criteria:
inclusion criteria: * at least a 1-year history of migraine with or without aura consistent with a diagnosis according to the international classification of headache disorders, 3rd edition, (ichd-3, 2018) * by history, the participant's migraines typically last between 4 and 72 hours if untreated or treated unsuccessfully and migraine episodes are separated by at least 48 hours of headache pain freedom * history of at least 2 migraine attacks per month in the 2 months prior to screening * have a sitting pulse rate ≥ 45 beats per minute (bpm) and ≤ 100 bpm during the vital sign assessment at the screening visit. clinical site may perform a maximum of 2 repeats of vital sign measurements if the initial measurement is out of range. * negative test results for benzoylecgonine (cocaine), methadone, barbiturates, amphetamines, benzodiazepines, cannabinoids, opiates, and phencyclidine at the screening visit and day -1; unless explained by concomitant medication use (eg, opioids prescribed for migraine pain) * participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period exclusion criteria: * difficulty distinguishing migraine headache from tension-type or other headaches * has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine as defined by ichd-3 * has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ichd-3 * required hospital treatment of a migraine attack 3 or more times in the 6 months prior to screening * has a chronic non-headache pain condition requiring daily pain medication (with the exception of pregabalin) * has clinically significant cardiovascular or cerebrovascular disease per the investigator's opinion * previously participated in an investigational study of ubrogepant * participation in any other clinical investigation using an experimental drug within 30 days prior to study intervention administration * participation in a blood or plasma donation program within 60 or 30 days, respectively, prior to study intervention administration

Keywords: ubrogepant erenumab galcanezumab safety tolerability interaction
early use of corticosteroids in non-critical patients with covid-19 pneumonia

Conditions: COVID-19

Summary: steroids has shown benefits in covid19 patients in observational studies. we hypothesized that early use of corticosteroids, low dose, in mild disease, can decrease progression to respiratory failure and death.

we are in the middle of a coronavirus pandemic, facing a large number of infections in serious cases and an increasing number of deaths in chile. as of june 11, 2020, there are 154092 cases confirmed by covid - 19 i and 2648 deaths in our country. most patients have mild disease, but older people and those with comorbidities can develop severe disease that requires hospitalization, some form of ventilatory support, and eventually intensive care unit admission. the pathophysiology occurs in two different overlapping phases, the initial pathogen with viral replication, followed by the host's inflammatory response with varying degrees of severity associated with different clinical characteristics. the pathological progression in some cases of severe covid-19 would be explained by an excess of proinflammatory cytokines, which leads to diffuse alveolar damage, with the development of acute respiratory distress syndrome (ards) and inflammatory compromise of multiple systems until death. in the absence of any proven antiviral therapy, current clinical treatment is primarily supportive care, supplemental oxygen, and mechanical ventilatory support. clinical trials have been published and called to demonstrate the usefulness of therapies in the context of this pandemic. the role of corticosteroids is not fully defined. observational studies report better results in decreasing disease progression in those covid-19 patients who received corticosteroids early. we hypothesize in this study that treatment in mild disease (defined as that requiring supplemental oxygen, but without the need for ventilatory support) can attenuate the host's excessive respiratory and systemic inflammatory responses. the objective of this study is to evaluate the effect of early treatment with prednisone to decrease the progression of the disease.

Eligibility criteria:
inclusion criteria: * 18 years or more * covid-19 confirmed by pcr * oxygen requirements until 35 % by venturi mask or 5 lt minutes by nasal cannula * consent form signed exclusion criteria: * previous steroid use 48 hours or more. * pregnancy * chronic respiratory failure * requirements of mechanical ventilation (invasive or no invasive) * chronic liver damage child pugh b or c * chronic kidney disease stage iv or v. * immunosuppressed * participation on other trial.
addressing psychological risk factors underlying smoking persistence in copd patients: the fresh start-ii study

Conditions: Copd; Smoking Cessation; Nicotine Dependence; Tobacco Use; Cigarette Smoking

Summary: chronic obstructive pulmonary disease (copd) is caused primarily by smoking and smoking cessation is the first-line treatment for slowing disease progression. despite this, nearly 50% of copd patients continue to smoke following diagnosis. smokers with copd report high rates of co-occurring conditions - nicotine dependence, depression, and anxiety - which serve as barriers to quitting. the current study will pilot test a behavioral intervention designed to target the common psychological factors underlying these co-occurring conditions and foster smoking cessation among copd patients.

chronic obstructive pulmonary disease (copd) is caused primarily by smoking and smoking cessation is the first-line treatment for slowing disease progression. despite this, nearly 50% of copd patients continue to smoke following diagnosis. smokers with copd report high rates of co-occurring conditions - nicotine dependence, depression, and anxiety - which serve as barriers to quitting. the proposed research will develop and pilot test a behavioral intervention designed to target the common psychological factors underlying these co-occurring conditions and foster smoking cessation among copd patients. the specific aim is to: aim: examine effects of psychological risk factor reduction on smoking outcome. we will conduct a pilot trial in which 62 participants are randomized to the multi-component behavioral treatment (9 weekly sessions) or self-guided treatment (mailing of printed self-help materials).the primary outcome is number of days abstinent for 2 weeks post-quit (range = 0-14 days).

Eligibility criteria:
inclusion criteria: eligible participants will be males and females who are: * diagnosed with copd (as documented in electronic health record \[ehr\]), * daily cigarette smokers (5 or more cigarettes per day over past 30 days), * intend to quit smoking within the next 60 days, * report at least moderate level of smoking for affective regulation (smq-r coping subscale score 30 or greater), * have access to a smart phone, tablet, or computer, and * are able to communicate fluently in english exclusion criteria: * any concurrent medical or psychiatric condition which would preclude ability to provide informed consent or perform study procedures (e.g., moderate to severe dementia and/or severe, uncontrolled schizophrenia), as determined by the treating physician or study pi.

Keywords: copd smoking cessation nicotine dependence tobacco use cigarette smoking behavioral treatment self-guided treatment