Kornimate/medical-research-clean huggingface dataset:
a clinical trial to assess the long term safety and tolerability of mk-0653c in japanese participants with hypercholesterolemia (mk-0653c-384)

Conditions: Hypercholesterolemia; Heterozygous Familial Hypercholesterolemia

Summary: this study will assess the safety and tolerability of ezetimibe (ez) 10 mg/atorvastatin (atora) 10 mg and ez 10mg/atora 20 mg fixed-dose combination (fdc) in japanese participants with hypercholesterolemia uncontrolled with monotherapy of ezetimibe 10 mg or atorvastatin up to 20 mg. there is no formal hypothesis for the study.


Eligibility criteria:
inclusion criteria * japanese * outpatient with hypercholesterolemia * has familial hypercholesterolemia (fh) diagnosed per genetic testing or meets two or more of the below criteria based on japan atherosclerosis society guideline 2012 (jas2012): hyper low-density lipoprotein (ldl)-cholesterolemia (an untreated ldl-c level of ≥180mg/dl); tendon xanthoma (tendon xanthoma on the backs of the hands, elbows, knees, etc. or achilles tendon hypertrophy) or xanthoma tuberosum; family history of fh or premature coronary arterial disease (within the participant's second degree relatives) * females must be of non-reproductive potential or agree to remain abstinent or use (or partner use) two acceptable methods of birth control from date of signed informed consent to the 14 days after the last dose of study drug * agree to maintain a stable diet that is consistent with the jas 2012 for prevention of atherosclerotic cardiovascular diseases for the duration of the study exclusion criteria * uncontrolled hypertension * type 1 or uncontrolled type 2 diabetes mellitus (treated or untreated) * homozygous familial hypercholesterolemia or has undergone ldl apheresis * had a gastrointestinal tract bypass, or other significant intestinal malabsorption * history of cancer within the past 5 years except for successfully treated dermatological basal cell or squamous cell carcinoma or in situ cervical cancer * human immunodeficiency virus (hiv) positive * history of drug/ alcohol abuse within the past 5 years or psychiatric illness not adequately controlled and stable on pharmacotherapy * consumes more than 25 g of alcohol per day * consumes more than 1l of grapefruit juice per day * currently following an excessive weight reduction diet * engaging in a vigorous exercise regimen (e.g.; marathon training, body building training etc.) or intends to start training during the study * hypersensitivity or intolerance to ezetimibe or atorvastatin * history of myopathy or rhabdomyolysis with ezetimibe or any statin * pregnant or lactating * taking any other investigational drugs and/or has taken any investigational drugs within 30 days
trevo® retriever registry post market surveillance

Conditions: Ischemic Stroke

Summary: the purpose of the trevo® retriever registry is to collect real world performance data of the trevo retriever which is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.

trevo retriever registry is a prospective, open-label, consecutive enrollment, multi-center, international registry that may enroll a maximum of 2000 patients at up to 100 sites worldwide. revascularization status will be assessed at the end of the procedure using the modified tici (thrombolysis in cerebral infarction)score. additional data collection will include: 1. day 90 mrs assessment 2. day 90 all cause mortality 3. neurological deterioration at 24 hours post procedure, defined as a four or more point increase in the nihss score from the baseline score 4. rates of device and procedure related serious adverse events (aes)

Eligibility criteria:
inclusion criteria: * subjects experiencing acute ischemic stroke who are eligible for restoration of blood flow using any approved trevo retriever in the neurovasculature to remove thrombus * trevo retriever is the initial mechanical neuro-thrombectomy device used to remove the thrombus * signed informed consent obtained * subject willing to comply with the protocol follow-up requirements * anticipated life expectancy of at least 3 months exclusion criteria: * the subject is participating in another mechanical neuro-thrombectomy device trial or any other clinical trial where the study procedure or treatment might confound the study end point.

Keywords: ischemic stroke mechanical thrombectomy device retriever
intervention trial evaluating focal therapy using high intensity focused ultrasound for the treatment of prostate cancer

Conditions: Prostate Cancer

Summary: the investigators aim to evaluate cancer control, genitourinary, rectal and overall health-related quality of life outcomes and effectiveness of focal therapy for localised prostate cancer using high intensity focused ultrasound (hifu).


Eligibility criteria:
inclusion criteria: * histologically proven prostate cancer on trans-rectal or transperineal template prostate biopsies * template biopsy: * unilateral disease (gleason ≤4+3) * bilateral disease: presence of clinically significant cancer in both sides (gleason ≤4+3) or clinically insignificant disease with a burden of \>50% of biopsy cores taken on that side, or bilateral clinically insignificant disease and \<50% of biopsy cores positive on any one side but with dominant disease burden on one side * stage t1-t2cn0m0 disease, as determined by local guidelines (radiological t3a permitted) * serum psa ≤15 * life expectancy of ≥10 years * signed informed consent by patient * an understanding of the german language sufficient to understand written and verbal information about the trial and consent process exclusion criteria: * men who have had androgen suppression/hormone treatment within the previous 12 months for their prostate cancer * men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging * men with an inability to tolerate a transrectal ultrasound * men with latex allergies as the hifu probe is covered with a latex condom sheath prior to insertion into the back passage * men who have undergone prior significant rectal surgery preventing insertion of trans-rectal hifu probe (decided on the type of surgery in individual cases) * men who have had previous hifu, cryosurgery, thermal or microwave therapy to the prostate. * men who have undergone a transurethral resection of the prostate (turp) for symptomatic lower urinary tract symptoms within 6 months. these patients may be included within the trial if deferred from consenting and screening until at least 6 months following the turp. * men not fit for major surgery as assessed by a consultant anaesthetist * men unable to have pelvic mri scanning (severe claustrophobia, permanent cardiac pacemaker, metallic implant etc likely to contribute significant artefact to images) * presence of metal implants/stents in the urethra * presence of prostatic calcification and cysts (on transrectal ultrasound) whose location will interfere with effective delivery of hifu therapy * men with renal impairment with a glomerular filtration rate of \<35ml/min (unable to tolerate gadolinium dynamic contrast enhanced mri).
phase iii open label study of medi 4736 with/without tremelimumab versus standard of care (soc) in recurrent/metastatic head and neck cancer

Conditions: Squamous Cell Carcinoma of the Head and Neck

Summary: this is a randomized, open-label, multi-center, 3-arm, global phase iii study to determine the efficacy and safety of medi4736 + tremelimumab combination or medi4736 monotherapy versus soc (extreme regimen) in the treatment of patients with scchn who have not received prior systemic chemotherapy for recurrent or metastatic disease.

patients will be randomized in a 2:1:1 ratio to medi4736 + tremelimumab combination therapy, medi4736 monotherapy, or soc. patients in all arms will continue therapy until progression. tumor assessments will be performed on computed tomography scans or magnetic resonance imaging scans, preferably with intravenous (iv) contrast. efficacy for all patients will be assessed by objective tumor assessments every 6 weeks for the first 24 weeks, then every 8 weeks thereafter until treatment discontinuation due to progression or toxicity. all patients will be followed every 3 months for survival after progression is confirmed.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years at the time of screening 2. documented evidence of recurrent or metastatic scchn (oral cavity, oropharynx, hypopharynx, or larynx). 3. a fresh tumor biopsy for the purpose of screening or an available archival tumor sample. tumor lesions used for fresh biopsies should not be the same lesions used as recist target lesions, unless there are no other lesions suitable for biopsy. 4. no prior systemic chemotherapy for recurrent or metastatic disease 5. world health organization (who)/eastern cooperative oncology group (ecog) performance status of 0 or 1 at enrollment 6. no prior exposure to immune-mediated therapy, exclusion criteria: 1. histologically or cytologically confirmed head and neck cancer of any other primary anatomic location in the head and neck not specified in the inclusion criteria including patients with scchn of unknown primary or non-squamous histologies (eg, nasopharynx or salivary gland) 2. tumor progression or recurrence within 6 months of last dose of platinum therapy in the primary treatment setting 3. receipt of any radiotherapy or hormonal therapy for cancer treatment within 30 days prior to first dose of study treatment 4. active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[eg, colitis, crohn's disease\], diverticulitis

Keywords: programmed cell death ligand 1 (pd-l1), medi4736, cytotoxic t-lymphocyte-associated antigen 4 {ctla-4}, pfs, scchn
restoration anatomic acetabular shell revision study

Conditions: Arthropathy; Hip Arthropathy; Hip Osteoarthritis

Summary: this study will be a non-randomized, ambidirectional (retrospective and prospective) study where all subjects will be followed prospectively. the study will evaluate the survivorship of the ras acetabular component in a previously failed total hip arthroplasty (tha) in a consecutive series of subjects who meet the eligibility criteria.


Eligibility criteria:
inclusion criteria: * subject is a candidate for a revision of a failed acetabular component with the restoration anatomic acetabular shell. * subject has signed an irb-approved, study specific informed consent form (icf). * subject is skeletally mature. * subject is a male or non-pregnant female. * subject is willing and able to comply with postoperative scheduled clinical evaluations. exclusion criteria: * subject has a non-stryker retained stem at the time of study device implantation. * subject has a body mass index (bmi) \> 45. * subject has an active or suspected latent infection in or about the affected hip joint at time of study device implantation. * subject has a mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care. * subject has compromised bone stock which cannot provide adequate support and/or fixation to the prosthesis. * subject is diagnosed with a systemic disease (e.g. lupus erythematosus) or a metabolic disorder (e.g. paget's disease) leading to progressive bone deterioration. * subject is immunologically suppressed or receiving steroids in an excess of normal physiological requirements (e.g. \> 30 days). * subject has a known sensitivity to device materials. * subject is a prisoner.
observational clinical investigation of arthrosamid in knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: this is a prospective, long-term, observational, all-comers, open-label, multi-centre clinical investigation enrolling subjects with knee osteoarthritis who is eligible for treatment with arthrosamid® according to the instruction for use.

this is a prospective, long-term, observational, all-comers, open-label, multi-centre clinical investigation enrolling subjects with knee oa who is eligible for treatment with arthrosamid® according to the instruction for use (ifu). all subjects will be followed over an observational period of five years with yearly follow-up check points. the first follow-up visit should be six months after the treatment. all follow up visits can be performed as telephone visits.

Eligibility criteria:
inclusion criteria: * stated willingness to comply with all study procedures and availability for the duration of the study * male or female, aged ≥ 18 years * clinical diagnosis of knee oa exclusion criteria: * if an active skin disease or infection is present at or near the injection site * if the joint is infected or severely inflamed * if a degradable intra-articular injectable such as hyaluronic acid is present, it must be expected to be absorbed according to manufacturer's information for the specific product, before injection with arthrosamid® * if the patient has previously received treatment with a different non-absorbable injectable/implant * if the patient has received a knee alloplasty or has any foreign material in the knee * if the patient has undergone knee arthroscopy within the last 6 months * if the patient has haemophilia or is in uncontrolled anticoagulant treatment
molecular characterization of patients with acute myeloid leukemia and the impact of clonal evolution in the response to therapeutic treatments

Conditions: Myeloid Leukemia, Acute

Summary: this study aims to analyze patients with mutated flt3 aml treated with specific therapy by means of molecular characterization methods, to identify the presence of clones and subclones at onset and to be able to follow their evolution during therapeutic treatment.

this study aims to analyze patients with mutated flt3 aml treated with specific therapy by means of single-cell molecular characterization methods, to identify the presence of clones and subclones at onset and to be able to follow their evolution during therapeutic treatment. in this way, it is possible to study how the mutational profile varies under therapeutic pressure and identify any alterations responsible for resistance. it will thus be possible to define a panel of new molecular markers to be included in the diagnostic routine to identify early patients refractory/resistant to treatment with flt3 inhibitors and thus improve the therapeutic approach of these patients.

Eligibility criteria:
inclusion criteria: * flt3 mutated exclusion criteria: * respoder to therapy

Keywords: aml flt3 single cell sequencing
a study of lebrikizumab (ly3650150) in participants 6 months to <18 years of age with moderate-to-severe atopic dermatitis

Conditions: Atopic Dermatitis; Eczema

Summary: the main purpose of this study is to measure the effect, safety and how well the body absorbs lebrikizumab in pediatric participants 6 months to \<18 years of age with moderate-to-severe atopic dermatitis (ad).


Eligibility criteria:
inclusion criteria: * have a diagnosis of ad prior to screening as stated in the criteria by the american academy of dermatology for at least, * 12 months if participants are ≥6 years of age * 6 months if participants are 2 to \<6 years of age * 3 months if participants are 6 months to \<2 years of age. * have an easi score ≥16 at the screening and baseline * have an iga score ≥3 (scale of 0 to 4) at the screening and baseline * have ≥10% bsa of ad involvement at the screening and baseline. exclusion criteria: * are currently enrolled or have participated within the last 8 weeks in a clinical study involving an investigational intervention or any other type of medical research judged not to be scientifically or medically compatible with this study. * treatment with the following prior to the baseline: * an investigational drug within 8 weeks or less than 5 half-lives, whichever is longer. * dupilumab within 8 weeks. note: the enrollment of participants with prior use of dupilumab will be limited to \<20%. * treatment with a topical investigational drug within 2 weeks prior to the baseline. * have received a bacillus calmette-guerin vaccination or treatment within less than 4 weeks before randomization.
sbrt treatment for lung metastasis from soft tissue sarcoma

Conditions: Metastasis From Malignant Tumor of Soft Tissues

Summary: in this study the investigators treat pm oligometastatic patients with sbrt. our objective is to evaluate rate of local control of treated lesions in patients treated with intensity modulated radiation therapy (imrt) using volumetric modulated arc therapy (vmat) for lung metastases from sts.

the investigators started to treat pm oligometastatic patients with stereotactic body radiotherapy. the investigators objective is to evaluate rate of local control of treated lesions in patients treated with intensity modulated radiation therapy (imrt) using volumetric modulated arc therapy (vmat) for lung metastases from soft-tissue sarcomas. overall and disease free survival will be evaluated as secondary endpoints.

Eligibility criteria:
inclusion criteria: * age 18 anni -85 years * ps according to ecog 0-2 * histopathologically confirmation of soft tissue sarcoma * metastatic lung lesion less than 4 * controlled primary tumor and other metastatic lesions * metastatic lesion less than 5 such as the definition of oligometastatic patients * written informed consent * contraindication to surgical resection * estimated survival ≥ 3 months * absence of progressive disease longer than 6 months * no chemotherapy was given for at least 3 months after sbrt * maximum diameter ≤ 5 cm exclusion criteria: * prior thorax radiation therapy * age \> 85 years * ps according to ecog \>2 * pregnant women * maximum diameter ≥ 5.1 cm * total volume of lung lesion greater than 1/3 of the whole pulmonary parenchima
effect of cis-9-cetylmyristoleate in sub-healthy subjects presenting with knee joint pain

Conditions: Knee Pain Intermittent

Summary: cis-9-cetylmyristoleate (cmo) is a naturally occurring fatty acid complex (fac). nutraceuticals containing cmo are used to improve knee pain despite the lack of placebo-controlled studies in humans. the aim of the double-blind controlled clinical trial is to explore the minimal effective dose of cmo for relieving knee joint pain.

methods: twenty-eight subjects, who are clinically or radiologically diagnosed as having mild degree arthritic knee joint pain, are randomized into 3 groups; groups a, b, c that contained 100%, 80%, and 62.4% of fatty acid component with 12.5% of cis-9-cetylmyristoleate (cmo), and control group d (starch 100%). the pain intensity, functional disability state and change in the general status were assessed for a 12-week ingestion period.

Eligibility criteria:
inclusion criteria: * sub-healthy persons \>18 years of age and knee joint pain with a 0-10 numerical rating scale (nrs) pain score ≤ 4. exclusion criteria: * current medication use related to arthritis; * current use of fac containing products; * clinical or radiological diagnosis as moderate degree arthritis accompanied by peri-articular spur formation, irregular joint margin, and/or subchondral cyst; * previous history of knee surgery; * pregnant, breastfeeding, or practicing contraception with reliable methods, or not accepting our guidelines during the research periods; * major pain other than knee joint pain; * current treatment of gastritis or gastric ulcer; * abnormal screening laboratory results; * major cardiac, renal disease, or disability that could affect adverse effect assessment or interfere with study completion when enrolled; * history of major procedures or operations that might affect study results; * enrollment in another clinical trial or human application testing; and * judged as unsuitable for human application testing.
does lma instead of et tube affect incidence of postoperative vomiting in children undergoing strabismus correction?

Conditions: Strabismus

Summary: the effect of airway management on vomiting after strabismus surgery is unknown. the purpose of this study is to find out whether the use of different airway devices, such as lma, which is a special mask placed in the throat or endotracheal tube (et tube), which is a soft tube placed in the wind pipe, affects the incidence of vomiting after surgery. two hundred six children between the ages of 2 and 12 years are expected to take part in this study.

the child will be checked by the study doctor to determine if he/she qualifies to be part of the study. the study doctor may not want the child to take part in this study if he/she is currently in another research study; or if the child has been in any other research study within the last 30 days, or if the child is extremely obese, or has reflux or another gi problem. if the child qualifies for the study, he/she will receive routine general anesthesia. for airway management, the child will have either a lma or et tube. the child has an equal chance of receiving either one of these airways devices, much like the coin flip. after surgery, the child will be transferred to the recovery room (pacu). if the child vomits in pacu, he/she will receive rescue medication, which can be repeated if the need arises. a research coordinator will call the parents the following day to find out whether the child vomited after leaving the hospital, in the car or at home, for any complications and receiving any medications.

Eligibility criteria:
inclusion criteria: * patients with elective uni- or bilateral strabismus repair exclusion criteria: * asa \>2 * history of prematurity * history of reflux * history of neurological disease * difficult airway * obesity

Keywords: strabismus lma et tube pov
efficacy and safety with ziprasidone in first-episode psychosis

Conditions: First Episode Psychosis

Summary: the aim of the study is to investigate the efficacy and safety of ziprasidone in patients with first episode psychosis.


Eligibility criteria:
inclusion criteria: * patients who meet dsm-iv criteria for first episode schizophrenia, schizophreniform disorder and schizoaffective disorder exclusion criteria: * patients with previously prescribed antipsychotic medication in 2 weeks or more * patients with substance-induced psychotic disorder, serious suicide attempt, neurological disorder, etc.
methotrexate and cyclosporine in treatment of early rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: to investigate whether cyclosporine, added to methotrexate and steroid, increases the possibility of inflammatory management early in the disease; furthermore to investigate the possible steroid-sparing effect of cyclosporine in patients with recently diagnosed rheumatoid arthritis.

design: multicentre, prospective, randomised, double-blind study with parallel design. selection of patients: patients with recently diagnosed rheumatoid arthritis (less than 6 months of persistent synovitis).

Eligibility criteria:
inclusion criteria: * synovitis in at least 2 joints. * compliance with the acr criteria for ra. * duration of no more than 6 months (from the first anamnestic non-traumatic synovitis of at least 6 weeks' duration). * informed consent. exclusion criteria: * age less than 18 years or more than 75 years * lack of co-operability. * previous treatment with dmard * corticosteroid treatment during the preceding 4 weeks. * contra indications for the treatments (awaiting the recommendations from novartis) * previous or present malignant or premalignant disease * poorly regulated hypertension * impaired renal function * immuno defective diseases, including hiv * cardiac or pulmonary insufficiency * serious arteriosclerosis * serious granulocytopenia or thrombocytopenia * impaired liver function (liver enzymes more than twice the highest normal limit). * alcohol consumption of more than 3 drinks a week. * poorly controlled epilepsy * lack of contraception in fertile patients * pregnancy and lactation * psoriasis * poorly regulated diabetes * anticoagulant treatment * known allergy to the medicine * medicamental interactions * other inflammatory rheumatic diseases