Kornimate/medical-research-clean huggingface dataset:
single arm study using the symphony -- mri guided focused ultrasound system for the treatment of leiomyomas

Conditions: Leiomyoma; Fibroid

Summary: single arm, first-in human feasibility study using the symphony - mri guided focused ultrasound system for the treatment of leiomyomas. the study is expected to accrue over 12 months. this study will help determine the feasibility to ablate leiomyomas, as measured by mr thermometry and contrast enhanced imaging. in addition, the study will look at the efficacy and safety of the treatment, as measured by the reduction in fibroid size and reduction in symptom severity score and adverse events. this study will help develop future pivotal trials using the same device.


Eligibility criteria:
inclusion criteria: 1. mr-hfu device accessibility to fibroids that at least 50% of fibroid volume can be treated 2. fibroids selected for treatment meet the following criteria 1. total planned ablation volume of all fibroids should not exceed 500 ml and 2. completely non-enhancing fibroids should not be treated 3. transformed sss score \>= 40 4. pre- or peri-menopausal, as indicated by clinical evaluation 5. weight \< 140 kg or 310 lbs 6. willing and able to attend all study visits 7. willing and able to use reliable contraception methods 8. uterine size \< 24 weeks 9. cervical cell assessment by pap: normal, low grade sil, low risk hpv or ascus subtypes of cervical tissue 10. waist circumference \<110cm or 43 inches exclusion criteria: 1. other pelvic disease (other mass, endometriosis, ovarian tumor, acute pelvic disease, significant adenomyosis, prolonged bleeding requiring further evaluation as determined by patient's gynecologist) 2. positive pregnancy test 3. extensive scarring along anterior lower - abdominal wall (\>50% of area) 4. surgical clips in the potential path of the hifu beam 5. tattoos in the potential path of the hifu beam 6. mri contraindicated 7. mri contrast agent contraindicated (including renal insufficiency) 8. calcification around or throughout uterine tissue that may affect treatment 9. communication barrier 10. fibroids not quantifiable on mri (e.g., multi-fibroid cases where volume measurements are not feasible) 11. pedunculated fibroids 12. bowel loops int he ultrasound beam path 13. patients with inability to tolerate prolonged prone position for up to 3 hours 14. patient with unstable medical conditions 15. patients with coagulopathy or under current anti-coagulation therapy
the influence of timing of cabergoline initiation on prevention of ohss

Conditions: Ovarian Hyperstimulation Syndrome

Summary: study the effect of early cabergoline administration in prevention of occurrence or decreasing the severity of ohss in patients undergoing intra cytoplasmic sperm injection.and its effect on oocyte maturation,fertilization and pregnancy rate..

patients less than 35years undergoing intra cytoplasmic sperm injection for infertility scheduled for gonadotropin releasing hormone agonist long protocol of ovarian stimulation. all patient will receive combined oral contraceptive pills (gynera, schering-plow: plough) starting from day 5 of cycle that precedes the stimulated cycle .on day 21 of that cycle all patients will start to receive gonadotrophin releasing hormone agonist in the form of (decapeptyl 0.1 sc daily and continued till the day of hcg administration). to ensure that all patients are completely down regulated and desensitized ,trans-vaginal ultrasound will be performed at day 2-3 of menses of stimulated cycle to ensure endometrial thickness less than 5 mm and no ovarian cysts.also serum e2 level is less than 50 pg/ml. then all patients will start to receive gonadotrophin ( hmg) (menogon, ferring pharmaceuticals, germany) 225 iu (international unit) intramuscular injection daily,with continuous scheduled follow up of ovarian response by serial trans -vaginal us to assess follicular growth together will serial serum e2 starting from day 6 of cycle and onwards.with adjustments of gonadotropin dose and monitoring frequency based on patient response. during follow up once the recruited patients fulfilling the inclusion criteria (serum e2 equal or more than 4000 pg/ml and /or 18 or more follicles of 11 mm diameter or more at any day of stimulation),they will be allocated randomly by computer generated cards and assigned by sealed envelopes by the treating doctor at the outpatient clinic. group a : will receive cabergoline 0.5 mg/day for 8 days, starting in the day of hcg (human chorionic gonadotropin ) injection. group b: will receive cabergoline 0.5 mg/day once the criteria of inclusion criteria is fulfilled and continued till the day of human chorionic gonadotropin (hcg ) trigger and continued 8 days more from day of trigger .

Eligibility criteria:
inclusion criteria: * female less than 35 years under going intra cytoplasmic sperm injection cycle for infertility (tubal factor or un explained infertility). * 18 or more oocyte 11 mm in diameter and/or e2 is more than 4000 pg/ml at any day of the stimulation cycle before or at hcg trigger exclusion criteria: * patient with one ovary * patients already receiving cabergoline treatment * severe male factor infertility. * thyroid dysfunction.

Keywords: cabergoline ovarian hyper stimulation syndrome (ohss)
a phase 1 study of an investigational drug, aln-at3sc, in healthy volunteers and hemophilia a or b patients

Conditions: Hemophilia A; Hemophilia B

Summary: the purpose of this study is to determine the safety, tolerability, and pharmacokinetics of aln-at3sc in healthy volunteers and hemophilia a or b patients.


Eligibility criteria:
inclusion criteria: part a (sad phase) inclusion: * healthy adult males aged 18 to 40 years inclusive at screening. * subjects with adequate complete blood counts and liver function tests. * willing to provide written informed consent and willing to comply with study requirements. part b \& c (mad \& md phase) inclusion: * adult male hemophilia patients aged 18 to 65 years inclusive at screening. * patients with adequate complete blood counts and liver function tests. * patients with moderate or severe, clinically stable hemophilia a or b (factor viii or factor ix ≤5%). * willing to provide written informed consent and willing to comply with study requirements part d (md phase in patients with inhibitors) inclusion: * same as parts b/c * a bethesda inhibitor assay \> 0.6 bu/ml exclusion criteria: part a (sad phase) exclusion: * subjects with a personal history and/or family history of venous thromboembolism (vte) * subjects with a known co-existing thrombophilic disorder * subjects with a history of multiple drug allergies or history of allergic reaction to an oligonucleotide or galnac. * subjects with a history of serious mental illness that includes, but is not limited to schizophrenia, bipolar disorder, severe depression requiring hospitalization or pharmacological intervention. * subjects who have a clinically relevant history or presence of cardiovascular, respiratory, gastrointestinal, renal, hematological, lymphatic, neurological, musculoskeletal, genitourinary, immunological including osteoarthritis and other inflammatory diseases, dermatological including rash, eczema, dermatitis, or connective tissue diseases or disorders. part b \& c (mad \& md phase) exclusion: * patients with a current serious mental illness that, in the judgment of the investigator, may compromise patient safety, ability to participate in all study assessments, or study integrity. * patients who have a clinically relevant history or presence of cardiovascular, respiratory, gastrointestinal, renal, neurological, inflammatory or other diseases that in the judgment of the investigator precludes their participation in the study. * patients with a known co-existing thrombophilic disorder * patients with a history of multiple drug allergies or history of allergic reaction to an oligonucleotide or galnac. * patients who are known to be hiv positive and have a cd4 count \<400 cells/μl part d (md phase in patients with inhibitors) exclusion: * same as parts b/c * patients who are known to be hiv positive and have a cd4 count \<200 cells/μl
study of oral high/low-dose cepharanthine compared with placebo in non hospitalized adults with covid-19

Conditions: Asymptomatic COVID-19

Summary: the purpose of this study is to evaluate the efficacy and safety of high/low-dose cepharanthine for the treatment of covid-19 in asymptomatic and non-pneumonia mild adult participants with covid-19 who do not need to be in the hospital, but in alternate care site.

screening participants will sign the appropriate informed consent form (icf) prior to completion of any study procedures. patients will be randomized to one of three arms, all participants will receive standardized medical treatment (smt) according to scheme for diagnosis and treatment of 2019 novel coronavirus pneumonia (the 9th trial edition) from health commission of china, including bed rest, adequate energy and nutrition, pay attention to water and electrolyte balance to maintain a stable internal environment, closely monitor and chinese traditional medicine, etc. * low-dose experimental arm：cepharanthine 60mg/day + smt * high-dose experimental arm：cepharanthine 120mg/day + smt * placebo control arm：placebo + smt the primary outcome measure is the time to viral clearance which defined as first positive nucleic acid test to the date of the first negative test (in two consecutive point). sars-cov-2 viral load was detected and quantified by rt-pcr using nasopharyngeal swabs . ct value\>35 for both orf1ab and n gene was considered as negativity.

Eligibility criteria:
inclusion criteria: * aged over 16 years old with all genders * sars-cov-2 positive（laboratory-confirmed reverse transcription polymerase chain reaction (rt pcr) test) * patient or immediate adult family member agrees to participate in this study and signs an informed consent form * asymptomatic or patients with mild covid-19 symptoms * confirmed sars-cov-2 infection within 5 days prior to randomization exclusion criteria: * confirmed sars-cov-2 infection within \> 5 days prior to randomization * ct shows pneumonia on admission * diagnosed as severe or critical covid-19 before intervention * has a history of chronic underlying disease and acute exacerbation of that underlying disease at the time of admission * females who are pregnant or breastfeeding

Keywords: asymptomatic covid-19 cepharanthine adult
evaluation of low phenylalanine formulas

Conditions: Phenylketonurias

Summary: ajinomoto cambrooke has developed a pku protein substitute that is a proprietary blend of purified glycomacropeptide (gmp) and essential amino acids, under the brand name glytactin®. one serving of such glytactin® products contains 20mg or less of phenylalanine (phe). the aim of the proposed study is to use this purified gmp-aa-based protein substitute, with less phe per gram of protein equivalent than other commercially available products, in children with pku at 100% of their protein substitute intake and evaluate its efficacy and the change in blood phe in comparison to phe-free l-aa-based protein substitutes.

study design this is a 2-stage, 15-week randomized crossover trial. the randomized crossover design was chosen as it reduces the influence of differences among individuals; and it offers statistical efficiency (requires fewer subjects than non-crossover designs). in summary, 2 groups of 9 participants each will be assigned to either (1) sequence 1: take gmp-aa-based ps for the first 4 weeks and then take only l-aa-based protein substitute for 4 weeks, or (2) take only l-aa-based protein substitute for the first 4 weeks and then take gmp-aa-based ps for 4 weeks. at the end of the first 4 weeks, a 2-week washout period will follow with both groups only consuming l-aa-based ps. randomization will be generated by a block randomization system and the random order will be kept within a sealed envelope. primary research objective the principal research objective of this study is to evaluate the effect on phe levels of a low-phe diet combined with a purified gmp-aa-based protein substitute (containing 1 mg phe/g protein equivalent), in the treatment of paediatric patients with pku. secondary research objectives the secondary objectives of the study aim to investigate whether there are any differences between the gmp-aa-based protein substitute and l-aa-based protein substitute in the frequency and quantity of protein substitute intake, if any gi (gastrointestinal) symptoms occur with ingestion of the gmp-aa-based protein substitute, effect on satiety (hunger) and mood and any differences in anthropometric data.

Eligibility criteria:
inclusion criteria: * patients with pku, aged 5 to 16 years of age, currently compliant with protein restricted diet and l-aa- and/or gmp-aa-based protein substitute willing to switch to a gmp-aa-based only product for 4 weeks. * 2 out of 4 last blood phe levels within target range (i.e. 50%): target range 120-360µmol/l \ 12 years exclusion criteria: * • milk protein allergy * pregnancy * severe medical diagnosis not related to pku * treatment with sapropterin hydrochloride (kuvan)
apex: adiposity prevention by exercise in black girls

Conditions: Cardiovascular Diseases; Heart Diseases; Obesity

Summary: to determine whether a one year afternoon exercise program will reduce adiposity in african american girls, ages 8 to 10.

background: obese children who engage in vigorous exercise programs show beneficial effects on total body percent fat (percent bf) and visceral adipose tissue (vat); however, little is known about how to prevent accretion of total body or visceral adiposity in high risk youths, such as african-american (aa) females.the project has important health implications for two reasons, as follows. there is a dearth of information concerning the effects of exercise interventions in school and community settings. if the study shows that an afternoon exercise program reduces accretion of general and visceral adiposity and has a favorable impact on fitness and health in a population that is at high risk of obesity, then schools may be encouraged to implement similar interventions to prevent juvenile obesity and associated health problems. the study was awarded in response to a program announcement on physical activity and cardiopulmonary health released in october 1994 jointly by the nhlbi, the national institute of diabetes and digestive and kidney diseases, and the national institute of nursing research. design narrative: the design involves randomization of 200 african american girls, eight to 10 years of age into intervention or control groups. after one year, the groups are compared to test the primary hypothesis that a one year afternoon exercise program will reduce accretion of general and visceral adiposity in these girls. then the girls will switch group assignments for the next year. the pattern of data over the three time points will show what happens over a two year period in which the youths are, or are not, involved in the exercise program. the measurements will include: (1) percent body fat with dual-energy x-ray absorptiometry; (2) visceral adipose tissue (vat) with magnetic resonance imaging; (3) cardiovascular fitness with a multi-stage treadmill test; (4) cardiovascular disease (cvd) risk factors (i.e., the ratio of total to high density lipoprotein cholesterol, insulin, systolic blood pressure, and fibrinogen); (5) free-living exercise and diet; (6) psychosocial variables (i.e., self-efficacy and self-concept); (7) sexual maturation; (8) anthropometric measures. the exercise program will be implemented in neighborhood schools for 90 minutes each weekday afternoon. transportation will be provided if needed. sessions will include motor skill instruction and aerobic exercises.

Eligibility criteria:
no eligibility criteria
polydextrose for patients with chronic kidney disease

Conditions: Chronic Kidney Diseases; Constipation

Summary: constipation is a common complication in patients with chronic kidney disease (ckd), especially in hemodialysis (hd) patients. reduced intake of fibre-rich food is among the most important causes of constipation. the study aims to investigate the possible influence of polydextrose (pdx) supplementation on constipation in patients with ckd on hd.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of chronic kidney disease * hemodialysis patients for more than 6 months * aged 18 years or older exclusion criteria: * patients pregnant * smokers * using antibiotics in the last 3 months * autoimmune diseases * clinical diagnosis of infectious diseases * clinical diagnosis of cancer * clinical diagnosis of aids
emergency/compassionate use - membranous vsd occluder

Conditions: Membranous; Ventricular; Septal; Defects; VSD

Summary: emergency/compassionate use of the amplatzer membranous vsd occluder


Eligibility criteria:
inclusion criteria: * emergency/compassionate use for patients not meeting the inclusion critera for the amplatzer membranous vsd clinical trial

Keywords: membranous ventricular septal defects vsd
telemedicine follow-up for early laryngeal cancer: a randomized controlled trial comparing care close to home versus standard of care

Conditions: Head and Neck Cancers; Laryngeal Carcinoma

Summary: the goal of this clinical trial is to evaluate whether telemedicine follow-up is a satisfactory and safe alternative to traditional follow-up care for patients treated for early glottic (vocal cord) cancer, particularly those who live far from a specialized head and neck oncology centre (hnoc). the main questions it aims to answer are: is patient satisfaction with telemedicine follow-up comparable to standard care? is the safety of telemedicine follow-up (measured by recurrence rates, complications, and survival) comparable to in-person follow-up at an hnoc? researchers will compare patients receiving telemedicine follow-up in a nearby hospital with standard in-person follow-up at the hnoc, to see if remote evaluation of endoscopic procedures can maintain patient satisfaction and safety outcomes. participants will: be randomly assigned to either a telemedicine follow-up group (if they live ≥ 45 minutes from an hnoc) or a standard of care group undergo follow-up including hd-laryngoscopy, according to clinical guidelines have endoscopy videos evaluated remotely by specialists at the hnoc (= telemedicine) (intervention group only) complete surveys including patient-reported outcomes and experience measures at baseline, 6 months, and 12 months


Eligibility criteria:
inclusion criteria: * patients who underwent tols for early stage glottic squamous cell carcinoma (t1 or carcinoma-in-situ) * a one-way travel time to the hnoc of ≥45 minutes (intervention group) or \< 30 minutes (control group) * within 2 years postoperatively * can speak and write dutch exclusion criteria: * patients will be excluded if they continue to undergo follow-up for other (head and neck) cancers in the hnoc.

Keywords: head and neck cancer follow-up patient satisfaction telemedicine patient reported outcome measures quality of life
next-gen ms: feed-forward pro data for ms research

Conditions: Multiple Sclerosis (MS)

Summary: this next generation learning health system for multiple sclerosis (next-gen ms) study is a sub-study of the ms-link™ outcomes study (nct04735406). the study aims to examine the effects of using feed forward patient reported outcomes (pros) data in real-world multiple sclerosis (ms) care settings. the study will be conducted within an emerging learning healthcare system (lhs).


Eligibility criteria:
inclusion criteria: * participants willing and able to provide written informed consent * participants with clinical diagnosis of multiple sclerosis (ms) exclusion criteria: * none

Keywords: multiple sclerosis patient reported outcomes patient determined disease steps learning healthcare system
readmap: reading in stroke alexia and typical aging

Conditions: Aphasia; Stroke; Alexia

Summary: loss of reading ability due to stroke, called alexia, likely affects over a million americans at any given time and causes difficulty performing many daily life functions, such as paying bills, using email/text, reading for pleasure, and reading signs in the community. understanding the brain and cognitive basis of alexia could improve diagnosis and treatment of this important problem. in this study, the investigators will perform a large-scale behavioral and brain imaging study of stroke survivors and typical older adults to improve our understanding of the brain and cognitive basis of reading in both of these groups. participants will complete a battery of tests of reading, speech, language, and thinking abilities. in addition, some participants will complete an mri. sessions will be completed across approximately 2-6 weeks, but may be extended depending on participants' schedules and availability. some participants will be invited to repeat these procedures once or twice in approximately 3-12 months to monitor for changes in reading abilities and mri measurements over time.


Eligibility criteria:
inclusion criteria: stroke survivors: * age \>= 18 * learned english at 8 years or younger * brain injury resulting from stroke controls: * age \>= 18 * learned english at 8 years or younger exclusion criteria for all groups: * history of other brain disorder that could interfere with our ability to interpret results (e.g., multiple sclerosis, dementia, head injury causing loss of consciousness) * severe psychiatric condition that would interfere with participation in the study * history of diagnosed learning disorder * hearing or vision loss that interferes with performance on behavioral tests even after correction with glasses/hearing aids. * inability to follow study procedures despite maximal support additional exclusion criteria for mris: * presence of metal in the body that is incompatible with mri * pregnancy * claustrophobia

Keywords: aphasia stroke brain injury speech language reading alexia apraxia