Kornimate/medical-research-clean huggingface dataset:
the effect on blood cells, known as platelets, using prasugrel vs clopidogrel in patients with the heart problem acute coronary syndrome (acs)

Conditions: Acute Coronary Syndrome

Summary: this is a multicenter, randomized, double-blind, cross-over study to compare the pharmacodynamic response in subjects with acute coronary syndrome receiving a 10-mg maintenance dose (md) of prasugrel compared with a 150-mg maintenance dose of clopidogrel, following a 900-mg loading dose (ld) of clopidogrel.


Eligibility criteria:
inclusion criteria: * present with acute coronary syndrome (acs) and have planned treatment with a one-time 900-mg loading dose of commercially available clopidogrel (administered as a single or cumulative dose). * are between the ages of 18 and 85 years. * willing and able to sign informed consent. exclusion criteria: * have overt st-segment elevation myocardial infarction (stemi). * have cardiogenic shock. * have refractory ventricular arrhythmias. * have new york heart association (nyha) class iv congestive heart failure. * have severe and uncontrolled hypertension. * have active internal bleeding or history of bleeding diathesis. * have an increased risk of bleeding. * have history of cerebrovascular accidents. * have certain abnormal blood level values. * are currently receiving chemotherapy or radiation therapy.
clinical impact of dedicated mr staging of ovarian cancer

Conditions: Ovarian Cancer

Summary: the only chance of cure for patients with advanced stage ovarian cancer is complete cytoreductive surgery (crs). the only way to determine whether complete crs can be achieved is by a laparoscopy. however, diffusion-weighted magnetic resonance imaging (dw-mri) has a very high sensitivity to detect small volume malignant disease, making it a potentially suitable staging tool. aim of this study is to determine the performance of dw-mri for predicting whether complete crs can be achieved.


Eligibility criteria:
inclusion criteria: * patients with advanced stage (figo stage iii or iv) ovarian cancer scheduled for primary or interval cytoreductive surgery * age \>18 years * written and signed informed consent * who 0-2 * able to read and write dutch exclusion criteria: * patients with contraindications for mri * patients with contraindications for crs * known additional malignancy
transcranial direct current stimulation therapy for sleepiness related to shift work disorder (tdcs-sword)

Conditions: Shift-Work Sleep Disorder

Summary: 1. to determine the effects of tdcs on subjective measures of sleepiness in night-shift workers with shift work disorder. 2. to determine the effects of transcranial direct current stimulation (tdcs) on vigilance in night-shift workers with shift work disorder.

this is a preliminary single-arm study. the study will last up to 6 weeks including the screening period. subjects will receive active tdcs for 30 minutes before their scheduled work hours at least 3x/week for two consecutive weeks. outcome measures will include: psychomotor vigilance test (pvt) and the karolinska sleepiness scale (kss)25,26 which will be obtained during the shift work.

Eligibility criteria:
inclusion criteria: * age 18-65 years * works 5 or more night shifts per month (each shift lasting at least 10 hours, with ≥6 hours worked between 10 pm and 8 am) with plans to maintain this schedule for the duration of the 3-week trial * meets the criteria for shift work disorder according to the international classification of sleep disorders24 and evaluation of a sleep medicine provider (physician or nurse practitioner) during a screening evaluation: 1. affirmative answers to do you experience excessive sleepiness? (yes/no); "do you experience difficulties with falling asleep during opportunities for sleep? (yes/no); "is the sleep or sleepiness problem related to a work schedule where you have to work when you would normally sleep? (yes/no)"; and "has this sleep or sleepiness problem related to your work schedule persisted for at least three months? (yes/no) 2. based on the evaluation of the sleep medicine provider, the sleep and/or wake disturbance are not better explained by another current sleep disorder, medical or neurologic disorder, mental disorder, medication use, poor sleep hygiene, or substance abuse disorder. * stable medication dosage over previous 4 weeks. * able to understand english and give a written informed consent document. exclusion criteria: * currently taking stimulant medications such as modafinil, armodafinil, methylphenidate, or dextroamphetamine. * history of automobile accident due to falling asleep while driving * inability to understand or read english * self-reported substance abuse (current) * excessive alcohol consumption defined as: * more than 3 glasses of wine a day * more than 3 beers a day * more than 60 ml of hard liquor a day * presence of cardiac pacemaker or automatic implantable cardioverter-defibrillator (aicd). * pregnancy, lactation (will be screened with urine pregnancy test) * non-removable metal or tattoos around head * use of implantable birth control device such as implanon * history of frequent severe headaches * unstable coronary artery disease * uncontrolled seizure disorder * uncontrolled hypertension * any other clinically significant condition that, in the opinion of the investigator, might put the subject at risk of harm during the study or might adversely affect the interpretation of the study data.

Keywords: transcranial direct current stimulation
novel alpha-glucan metabolism

Conditions: Healthy Volunteers

Summary: these are the characteristics of the project: monocentric: double blind randomized and crossover: you will test all the 3 products in random order.

this study will be randomized, double blind, placebo-controlled, single-center, and 3x3 crossover in design. eligible participants will be randomized to receive the below products in single dose and in different random sequence, as determined by the randomization system 1. 50 g novel alpha glucan 2. 50 g (rapidly digestible control) 3. 15 g (dietary fiber)

Eligibility criteria:
inclusion criteria: healthy status (based on anamnesis) body mass index (bmi) between 18.5 and 29.9 kg/m2 able to understand and sign informed consent form. exclusion criteria: 1. pregnant or lactating women 2. type i and type 2 diabetes 3. known food allergy or intolerance to test product 4. major medical/surgical event in the last 3 months potentially interfering with study procedures and assessments 5. abnormal bowel transit, history of a gastrointestinal disorder (e.g., inflammatory bowel disease, diverticular diseases, colon cancer), or history of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average or chronic or recurrent diarrhea with spontaneous bowel movements more often than 3 times daily 6. any concomitant medication potentially interfering with study procedures and assessment: such as antibiotics, antiacids, or other medications impacting transit time, colonoscopy, irrigoscopy or other bowel cleansing procedures four weeks prior the test 7. recent episode of an acute gastrointestinal illness 8. alcohol intake higher than 2 servings per day. a serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer. 9. smokers 10. volunteer who cannot be expected to comply with the protocol 11. family or hierarchical relationships with clinical innovation lab team
long-term safety and tolerability of hrs-5965 in patients with paroxysmal nocturnal hemoglobinuria

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Summary: this is a multicenter, single-arm, open-label study. patients with paroxysmal nocturnal hemoglobinuria who had previously received and completed the hrs-5965 study well included. all eligible subjects received hrs-5965 tablets or capsules until the end of treatment in this study.


Eligibility criteria:
inclusion criteria: 1. patients who have previously received and completed hrs-5965 study treatment, and are judged by the investigator to have treatment benefit and may benefit from continued treatment of hrs-5965 and patients in the control group of who received eculizumab treatment. exclusion criteria: 1. known or suspected hereditary or acquired complement deficiency; 2. history of infection with capsular bacteria (e.g., meningococcus, pneumococcus, etc.)
regulation of hepatic insulin extraction

Conditions: Diabetes

Summary: * this study is in the area of type 2 diabetes and genetics * healthy volunteers and those with mild type 2 diabetes may be eligible to participate * this study is searching for genes that may affect the body's processing/digestion of glucose/sugar

this study is looking at the genetic influences of type 2 diabetes. it also is investigating the various gastric hormones including but not limited to: insulin, c-peptide, gip, glp, \& xenin.

Eligibility criteria:
inclusion criteria: * ages 18-65 * non-diabetic * diabetes controlled with diet or with pills * no family history of diabetes * family history of type 2 diabetes * personal history of gestational diabetes exclusion criteria: * \ 65 years of age * medications that affect glucose (sugar) levels * kidney disease * liver disease * heart/cardiovascular disease

Keywords: diabetes genetics oral glucose tolerance testing family history of diabetes gestational diabetes
ultrasound-guided erectro spinae plane block versus stellate ganglion block for patients with upper limb acute herpes zoster pain.

Conditions: Acute Herpes Zoster Pain Managment

Summary: herpes zoster (hz) is a painful, eruptive, viral condition results from reactivation of the latent varicella zoster virus after the primary infection. the selection of an effective analgesic method in the acute phase of herpes zoster can decrease the incidence of postherpetic neuralgia by reducing neural sensitization. the stellate ganglion is present in 80% of the general population and is composed of the inferior cervical ganglion and the first thoracic ganglion fusion. it lies anterior to the neck of the first rib and extends to the inferior aspect of the transverse process of c7. the erector spinae plane (esp) block has been reported to provide diffuse and effective analgesia in the cervical, thoracic, and lumbar regions.

especially for elderly patients, when cell-mediated immunity wanes, common symptoms of hz appear, primarily as pain in a dermatomal distribution with a burning, sharp pain sensation (paresthesia) and itching, in addition to development of a vesicular rash. the selection of an effective analgesic method in the acute phase of herpes zoster can decrease the incidence of postherpetic neuralgia by reducing neural sensitization. the sympathetic fibers for the head, neck, heart, and upper limbs arise from the first thoracic segments, ascend through the sympathetic chain, and synapse in the superior, middle, and inferior cervical ganglions. the stellate ganglion is present in 80% of the general population and is composed of the inferior cervical ganglion and the first thoracic ganglion fusion. it lies anterior to the neck of the first rib and extends to the inferior aspect of the transverse process of c7. the erector spinae plane (esp) block has been reported to provide diffuse and effective analgesia in the cervical, thoracic, and lumbar regions.

Eligibility criteria:
inclusion criteria: * patients over the age of 21 with upper limb herpetic eruption lasting shorter than a week along with moderate to severe pain who got adequate antiviral medications exclusion criteria: * we will exclude patients who refuse to participate, those who are taking anticoagulant medications, have secondary bacterial infections of the dermatome, those who have an allergy to local anesthetics or serious disease of the heart ( e.g. heart block), lung, kidneys and those who had a history of neck surgery, such as thyroid cancer.
genes, exercise, memory and neurodegeneration

Conditions: Alzheimer's Disease

Summary: the primary purpose of this pilot study is to determine whether african americans with mild alzheimer's disease (ad) can be enrolled and retained in a 6-month aerobic exercise-training study.

this study will examine the effects of aerobic exercise-training on neurocognitive function, and on cerebral glucose homeostasis. it is yet to be determined whether african americans with mild ad can be recruited into such a study, nor has the relationship of fitness adaptation to neurocognitive function been systematically examined in this population. in addition to the goal of assessing the intervention effects, the study will evaluate the differential relationships of apoe to aerobic fitness-induced changes in neurocognition. the long-term goal is to explore the mechanism by which fitness adaptation exerts an effect on neurocognition, notably, low levels of high-density lipoprotein cholesterol (hdl-c), elevated inflammation (c-reactive protein (crp) and interleukins (il-1a)), deranged glucose homeostasis, hypertension and endothelia dysfunction are precursors of arteriolosclerosis, decreased cerebral perfusion and oxygen deprivation, all of which may increase ad risk. because many of these putative ad risk factors are susceptible to lifestyle alterations, the study will also assess their roles in aerobic fitness-related improvements in cognitive function and reduction in ad risk.

Eligibility criteria:
inclusion criteria: * age over 60 years * ability to exercise vigorously without harm * mild ad * study partner * in good general health * willing to exercise for 6 months * body mass index (bmi) less than 37 * women participants must be postmenopausal for at least 2 years, and maintain current hormone replacement therapy status and allowed medication usage for the duration of the study exclusion criteria: * mmse score below 20 * tg (triglyceride) greater than 400 mg/dl * ldl-c levels greater than 95% or hdl-c levels less than 10% of age and sex-adjusted norms

Keywords: apoe apolipoprotein e cognition disorders neurocognition
efficiency and outcomes of stress-only anger and d-spect stress-only spect mpi

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to compare clinical efficiency and patient outcomes using ultra low-dose stress only tc-99m and solid-state spect versus traditional anger spect.


Eligibility criteria:
inclusion criteria: * bmi \< 35 kg/m2 * lvef \> 40% * exercise stress * elective out-patients * no known cad (\>50%) by catheterization * no history of prior myocardial infarction exclusion criteria: * lbbb * pacemaker * atrial fibrillation * frequent pac's or pvc's * inability to achieve at least 6 minutes

Keywords: mpi spect stress-only spectrum dynamics camera anger
bcma-targeted car-t cell therapy for relapsed/refractory multiple myeloma and plasma cell disease

Conditions: Multiple Myeloma; Neoplasm, Plasma Cell; Multiple Myeloma in Relapse

Summary: this is a single arm study to evaluate the efficacy and safety of bcma-targeted car-t cells therapy for patients with relapsed/refractory multiple myeloma.

there are limited options for treatment of relapse/refractory multiple myeloma. bcma is expressed on most multiple myeloma cells so it is an ideal target for car-t. in this study, investigators will evaluate the safety and efficacy of car-t targeting bcma in patients with relapsed/refractory multiple myeloma. the primary goal is safety and efficiency assessment, including adverse events and disease status after treatment.

Eligibility criteria:
inclusion criteria: 1. signed written informed consent; 2. diagnose as relapsed /refractory multiple myeloma or other plasma cell disease, and meet one of the following conditions: 1. failed to standard chemotherapy regimens; 2. relapse after complete remission, high-risk and / or refractory patients ; 3. relapse after hematopoietic stem cell transplantation; 3. evidence for cell membrane bcma expression； 4. all genders, ages: 18 to 75 years； 5. the expect time of survive is above 3 months; 6. kps\>60； 7. no serious mental disorders ; 8. left ventricular ejection fraction ≥50% 9. sufficient hepatic function defined by alt/ast≤3 x uln and bilirubin≤2 x uln; 10. sufficient renal function defined by creatinine clearance≤2 x uln; 11. sufficient pulmonary function defined by indoor oxygen saturation≥92%; 12. with single or venous blood collection standards, and no other cell collection contraindications; 13. ability and willingness to adhere to the study visit schedule and all protocol requirements. exclusion criteria: 1. previous history of other malignancy; 2. presence of uncontrolled active infection; 3. evidence of disorder that need the treatment by glucocorticoids; 4. active or chronic gvhd； 5. the patients treatment by inhibitor of t cell； 6. pregnant or breasting-feeding women; 7. any situation that investigators regard not suitable for attending in this study (e.g. hiv , hcvinfection or intravenous drug addiction) or may affect the data analysis.

Keywords: multiple myeloma bcma chimeric antigen receptor t cell
pilot study to evaluate a voice journaling application in adolescents with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the overall goal of this pilot study is to evaluate the feasibility and acceptability of the kintsugi voice journaling app in adolescents with cf to inform the design of future observational and interventional trials. additionally, the investigators aim to evaluate the potential impact of the voice journaling app on key clinical outcomes in cf.


Eligibility criteria:
inclusion criteria: 1. diagnosis of cystic fibrosis based on sweat chloride (≥60) or two known disease-causing mutations 2. age 14 - 18 years 3. history of elevated gad-7 and/or phq-9 on screening questionnaires completed during routine cf clinical visits within the past year 4. clinically stable at the time of enrollment, without increased respiratory and/or gi symptoms or treatment with iv and/or oral antibiotics for an acute illness for the 14 days prior to enrollment visit. participants receiving inhaled antibiotics every other month are eligible to enroll. participants receiving chronic oral antibiotics, including thrice weekly azithromycin will be eligible to participate 5. access to an ios device (iphone or ipad) and internet/data plan 6. parent/participant enrolled in mychart 7. willing to participate in study after informed consent and assent has been obtained 8. english speaking exclusion criteria: 1. endorsement of suicidal ideation on the baseline phq-9 (item 9) questionnaire at the enrollment visit 2. developmental or cognitive delay preventing participant from interacting with voice journaling app 3. unable to speak and write proficiently in english 4. enrollment in another behavioral health study 5. actively in treatment with a mental health provider
clinical performance of a daily disposable toric silicone hydrogel contact lens

Conditions: Astigmatism

Summary: the purpose of this study is to obtain on-eye clinical performance data to evaluate the stability of axis orientation of ddt2 toric contact lenses in the intended population.

this is a single-visit, non-dispense study where subjects will be exposed to the test lenses for approximately 1 hour.

Eligibility criteria:
inclusion criteria: * able to understand and sign an informed consent form; * successful wear of spherical or toric soft contact lenses in both eyes, as specified in the protocol; * willing to not use rewetting/lubricating drops at any time during the study; * other protocol-specified inclusion criteria may apply. exclusion criteria: * any eye condition that would contraindicate contact lens wear, as determined by the investigator; * history of eye surgery within the previous 12 months, as specified in the protocol; * current or history of dry eye in either eye that, in the opinion of the investigator, would preclude contact lens wear; * other protocol-specified exclusion criteria may apply.

Keywords: toric contact lens daily disposable silicone hydrogel contact lens axis orientation astigmatism
benefit of iqp-vv-102 in reducing postprandial glucose level in overweight caucasian subjects

Conditions: Prediabetes; Hyperglycemia

Summary: in this trial, the investigational product , the active ingredients which has been proven to reduce postprandial glucose in healthy and diabetic patients, will be tested. the primary aim of this clinical study is to evaluate the possibility of the investigational product to reduce the rise of postprandial glucose auc level in overweight caucasian subjects with normal to prediabetic biomarkers (ifg/hba1c), without prompting a disproportionate rise in insulin levels.


Eligibility criteria:
inclusion criteria: * caucasian * bmi between ≥ 25 and \< 30 kg/m2 * normal to prediabetic biomarkers: fbg 3.9-6.9 mmol/l / 70-125mg/dl and hba1c 4-6.4% * willing to take test meal and adhere to consumptions of pre-prepared meals supplied (controlled by subject diary) * willing to maintain same level of physical activity during the study * willing to arrive at the study site with the same, non-strenuous means of transportation during the study * negative pregnancy testing (beta hcg) for women of childbearing potential during screening * women of child-bearing potential have to agree to use appropriate birth control methods during the study period * written informed consent of the subject to participate is a prerequisite for study participation exclusion criteria: * known sensitivity to l-arabinose and grape marc extracts, or any sources of the active ingredients and excipients * use of medications or dietary supplements that may influence body weight 4 weeks, and gastrointestinal functions 2 weeks prior to enrolment and during the study * use of anti-diabetic medication * strenuous exercise within one day prior to blood glucose sampling (including screening). * history of bariatric surgery, small bowel resection, or extensive bowel resection * difficult veins * recent blood donation in the last 1 month prior to study * pregnancy or nursing * clinically relevant excursions of safety parameters * any other serious condition or disease that renders subjects ineligible * smoking * exceeding safe alcohol consumption (men: ≥ 21 units/week; women: ≥ 14 units/week) and any alcohol consumption within 24 hours before venous blood glucose sampling * all vegetarians and subjects with self-reported diet high in fat or protein * subjects are not able to communicate with local study staff * recent antibiotic and cortisone use up to one week and during the study * participation in another study during the last 30 days of the screening visit (v1)