Kornimate/medical-research-clean huggingface dataset:
evaluation of orally administered amcenestrant (sar439859) in japanese postmenopausal patients with advanced breast cancer (ameera-2)

Conditions: Breast Cancer

Summary: primary objective: to assess the incidence rate of dose-limiting toxicity and to confirm the recommended dose as well as the maximum tolerated dose of sar439859 administered as monotherapy to japanese postmenopausal women with estrogen receptor positive and human epidermal growth factor receptor 2-negative advanced breast cancer. secondary objective: * to characterize the overall safety profile of sar439859 administered as monotherapy. * to characterize the pharmacokinetic profile of sar439859 administered as monotherapy. * to evaluate the antitumor activity of sar439859 administered as monotherapy and the clinical benefit rate (complete response, partial response and stable disease ≥ 24 weeks).

the duration of the study for an individual participant will include a period to assess eligibility (screening period) of up to 4 weeks (28 days), a treatment period of at least 1 cycle (28 days) of study treatment, and an end of treatment (eot) visit at least 30 days (or until the participant receives another anticancer therapy, whichever is earlier) following the last administration of study treatment. study treatment may continue until precluded by unacceptable toxicity, disease progression, or upon participant's request.

Eligibility criteria:
inclusion criteria : * participants must be postmenopausal women. * breast adenocarcinoma patients with locally advanced not amenable to radiation or surgery, inoperable and/or metastatic disease. * either the primary or any metastatic site must be positive for estrogen receptor (er) (\>1% staining by immunohistochemistry). * either the primary tumor or any metastatic site must be human epidermal growth factor receptor 2 non-overexpressing. * patients with at least 6 months of prior endocrine therapy. exclusion criteria: * eastern cooperative oncology group performance status (ecog) ≥2. * significant concomitant illness that would adversely affect participation in the study. * patients with a life expectancy less than 3 months. * patient not suitable for participation, whatever the reason. * major surgery within 4 weeks prior to first study treatment administration. * treatment with strong and moderate cytochrome p450 3a inhibitors/inducers. * patients with known endometrial disorders, uterine bleeding or ovarian cysts. * treatment with anticancer less than 2 weeks before first study treatment. * prior treatment with selective estrogen receptor down (serd)-regulator (except fulvestrant for which a washout of at least 6 weeks is required). * inadequate hematological function. * inadequate renal function with serum creatinine ≥1.5 x upper limit of normal (uln). * liver function: aspartate aminotransferase \>3 x uln, or alanine aminotransferase \>3 x uln. total bilirubin \>1.5 x uln. * non-resolution of any prior treatment related toxicity to \<grade 2, except for alopecia the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
aripiprazole in the treatment of tourette's syndrome

Conditions: Tourette's Syndrome

Summary: this is an open-label, flexible dose study designed to evaluate the safety and efficacy of aripiprazole in ts (or chronic tic disorder) subjects with or without associated oc symptoms and with or without adhd symptoms.

this is an open-label, flexible dose study designed to evaluate the safety and efficacy of aripiprazole in ts (or chronic tic disorder) subjects with or without associated oc symptoms and with or without adhd symptoms.

Eligibility criteria:
inclusion criteria: dsm-iv primary diagnosis of tourette's syndrome or chronic tic disorder; "moderate" severity as reflected on the cgi or the ygtss; normal ecg; and, written informed consent/assent. exclusion criteria: female subjects of childbearing potential who are not practicing an effective method of birth control (including abstinence); subjects who are pregnant or nursing women; subjects with known seizure disorder, a history or seizures or with conditions that lower seizure threshold; subjects who currently meet dsm-iv criteria for: schizophrenia, schizoaffective disorder, delusional disorder, or psychotic disorder not otherwise specified; subjects with a psychoactive substance abuse disorder (within the past 3 months); subjects with known allergy or hypersensitivity to aripiprazole; subjects who have any depot neuroleptic within one treatment cycle or any other changes in psychoactive medications (with the exception of antidepressants) in one month and two months for antidepressants prior to study entry for first administration of study medication; subjects who have clinically significant abnormalities based on physical examination, medical history, ecg, or laboratory tests; and, subjects on medication that pose drug interaction potential with aripiprazole such as carbamazepine, ketoconazole, paroxetine, and fluoxetine.
shamir aspheric ophthalmic lenses (mylens) for myopic control clinical trial

Conditions: Myopia

Summary: the aim of this clinical trial is to compare the rate of myopic progression in children wearing aspheric (mylens) and spherical/ toric ophthalmic lenses. the proposed lens design is an aspheric lens which is supposed to slow myopic progression in children by unique asphericity (proprietary information). myopic progression is quantified by changes in axial length (al) and cycloplegic refractive error (rx) will be monitored for 6-12 months (6 months crossover) with double-masking. peripheral refraction and ocular aberration will be evaluated.

visual manipulation induced by progressive addition lenses (pals) have been shown to inhibit eye growth and myopia development in children with up to 11% to 21% efficacy compared to single vision lenses. however, the treatment effect of pals is statistically significant but clinically insufficient. the current study aims at investigating the use of spectacle lenses with a unique novel design for myopia control in children. this prospective one-year randomized clinical study will evaluate axial elongation and myopia progression in eyes using the novel lens design compared to those using the conventional single-vision design. it is a double-masked, cross-over study. one eye will be fitted with the study lens and the other eye will be fitted with the single-vision lens. subjects will be asked to wear the spectacles for 6 months and the two lens designs will be swapped in the next 6 months after a wash-out period of 2 weeks. both the subjects and examiners will not aware the lens design being used by the subjects in each phase.

Eligibility criteria:
inclusion criteria: * myopia between 0.75 \~ - 4.50 d and with-the-rule astigmatism not more than 1.50 d * difference between eyes, no more than 1.25 spherical equivalent * best corrected visual acuity (va) is equal to or better than 0.10 in logmar scale (snellen va 6/7.5 or better) * eyes straight at distance and near with best subjective correction * willing to be randomized and wear the study spectacles according to the instructions from practitioner * willing to come back for follow up in the optometry clinic during the study period exclusion criteria: * abnormal ocular and general health * prior myopic treatment (e.g. refractive surgery and progressive lens wear for myopic control) before and during the study period * history of rigid contact lenses (including orthokeratology lenses) wearing * systemic condition which might affect refractive development (for example, down syndrome, marfan's syndrome) * ocular conditions which might affect the refractive error (for example, cataract, ptosis).

Keywords: myopia control, aspheric lenses, children
a new intervention for social communication skills following brain injury

Conditions: Brain Injuries

Summary: to investigate the effectiveness of a peer-led social skills training intervention compared to social activity (usual care) to improve social communication skills following severe brain injury.

a pilot study first tested the feasibility of the approach and the sensitivity of existing outcome measures to changes in group social interaction. following amendments to the pilot protocol, twelve new participants with severe abi were recruited from a residential post-acute rehabilitation centre in april 2015. an experimental parallel group design was used to compare a peer-led group intervention to a staff-led social activity group. participants were randomised to a peer-led intervention (n=6) or a staff-led social activity group (usual care) (n=6). the groups met twice a week for 8 weeks. a peer with severe abi was trained separately to facilitate interaction in the peer-led group. the training took place in 16 individual sessions over 4 weeks. group behaviour was measured twice at baseline, after intervention and at maintenance (4 weeks) using measures meeting reliability, validity and responsiveness criteria tested in the pilot study.

Eligibility criteria:
inclusion criteria: * adults between 18 and 70 years * a diagnosis of severe traumatic brain injury (tbi) or severe acquired brain injury (abi) with similar cognitive presentation to tbi * minimum of six months post injury * evidence of a social communication impairment as a result of injury * ability to tolerate group activity exclusion criteria: * significant aphasia * severe depression or psychiatric disorder * insufficient english to converse with peers * profound cognitive impairment

Keywords: social skills social communication cognitive communication traumatic brain injury acquired brain injury communication partner training peer partner training peer mentoring rehabilitation
a phase i study to assess the safety of pegcetacoplan (apl-2) as an add-on to standard of care in subjects with pnh

Conditions: Paroxysmal Nocturnal Hemoglobinuria (PNH)

Summary: this study will be the initial exploration of pegcetacoplan in patients with pnh. the assessments of the safety, tolerability, pk, and pd following administration of single and multiples doses of pegcetacoplan will guide decisions to further develop the drug.


Eligibility criteria:
inclusion criteria: * male or female * at least 18 years of age * weigh \>55 kg * diagnosed with pnh * on treatment with eculizumab (soliris®) for at least 3 months * hb \< 10 g/dl at screening or have received at least one transfusion within 12 months prior to screening * platelet count of \>30,000/mm3 * absolute neutrophil count \> 500/mm3 * women of child-bearing potential (wocbp) must have a negative pregnancy test at screening and must agree to use protocol defined methods of contraception for the duration of the study (see below) * males with female partners of child bearing potential must agree to use protocol defined methods of contraception (see below) and agree to refrain from donating sperm for the duration of the study * willing and able to give informed consent exclusion criteria: * active bacterial infection * known infection with hepatitis b, c or hiv * hereditary complement deficiency * history of bone marrow transplantation * participation in any other investigational drug trial or exposure to other investigational agent, device or procedure within 30 days * evidence of qtcf prolongation defined as \> 450 ms for males and \> 470 ms for females at screening * creatinine clearance (crcl) \< 50 ml/min (cockcroft-gault formula) at screening * breast-feeding women * history of meningococcal disease * no vaccination against n. meningitidis types a, c, w, y and b (administered as two separate vaccinations), pneumococcal conjugate vaccine or pneumococcal polysaccharide vaccine 23 (pcv13 or ppsv23, respectively) and haemophilus influenzae type b (hib) vaccination within 2 years prior to day 1 (visit 2) dosing.

Keywords: pnh paroxysmal nocturnal hemoglobinuria complement inhibitor anemia hemoglobinuria hematologic diseases extravascular hemolysis (evh) intravascular hemolysis (ivh) c3 inhibitor
medico-economic impacts of nelly service for not on dialysis severe chronic kidney disease

Conditions: Chronic Kidney Disease stage4; Kidney Diseases

Summary: this medico-economic research project (prme) aim to analyse nelly service efficiency for not on dialysis severe chronic kidney disease (dfg \< 30ml/mn) patients care. nelly is a service that includes telemonitoring, educational therapy and support for patients with severe chronic kidney disease.

nelly study is a multicentre trial, with stepped wedge randomized controled clusters. 2 strategies will be compared: usual patients follow-up and nelly service. the primary endpoint of the study is incremental cost-effectiveness ratio. this 3 years study will include 600 french patients. nelly service, offering telemonitoring, educational therapy and support to patients with severe chronic kidney disease, is based on an app, both for patients and health professionals, named ap'telecare (@tmm).

Eligibility criteria:
inclusion criteria: * patient with chronic kidney disease stage 4 * patient with at least 1 cardiovascular comorbidity and / or diabetes * patient with internet connexion from home * patient having given his express consent exclusion criteria: * dialysed patient * refusal of patient to take part in the research * impairment of vital prognosis within a short period * patient expecting a transplant from a living donor within 6 months

Keywords: telemedicine telemonitoring educational therapy
acupuncture treatment for knee osteoarthritis with sensitive acupoints and tender points

Conditions: Acupuncture; Knee Osteoarthritis; Sensitive Acupoints; Tender Points

Summary: the investigators plan to investigate the effectiveness of acupuncture at highly sensitive points, compared with lowly/non-sensitive points or no acupuncture (waiting-list), in improving pain, joint function and quality of life, among patients with koa. the safety of acupuncture will also be assessed during the study period.

participants in the high sensitization group receive acupuncture treatment at the five highly sensitive points; participants in the low/non-sensitization group receive acupuncture treatment at the five low/non-sensitive points and all other treatment settings will be the same as in the high sensitization group. patients in the waiting-list group will receive standard acupuncture treatment after the study is completed.

Eligibility criteria:
inclusion criteria: * participants aged 40 years or older and diagnosed with mild or moderate knee osteoarthritis(koa) are eligible to participate in the study * the following criteria are used for diagnosis of koa: * refractory knee pain for most days in the last month; * joint space narrowing, sclerosis or cystic change in subchondral bone (as demonstrated in x-ray); * laboratory examinations of arthritis: clear and viscous synovial fluid (≥2 times) and white blood cell count \< 2000/mm3; * morning stiffness continues less than 30 minutes; * bone sound exists when joints was taking flexion and/or extension. if a patient meets criteria 1 and 2, or criteria 1, 3, 4, and 5, a diagnosis of koa is confirmed. exclusion criteria: patients will be excluded if they meet any of the following: * diagnosed with conditions leading to skeletal disorders, such as tuberculosis, tumors or rheumatism of the knee joint and rheumatoid arthritis; * present sprain or trauma in the lower limb; * unable to walk properly due to foot deformity or pain; * present with mental disorders; * present with comorbidities including severe cardiovascular disease, liver or kidney impairment, immunodeficiency, diabetes mellitus, blood disorder or skin disease; * females who are pregnant or lactating; * using physiotherapy treatments for osteoarthritis knee pain; * have used intra-articular injection of glucocorticoid or viscosupplementation in the past six months; * received knee-replacement surgery; * diagnosed with severe (stage 4, according to kellgren and lawrence radiographic classification) or late clinical stage of koa; * have a swollen knee or positive result of floating patella test; or' * are participating or have participated in the other clinical trials.
recurrence rates of type i gastric neuroendocrine tumors treated with long-acting somatostatin analogs

Conditions: Gastric NET

Summary: this study evaluates the efficacy of long-acting somastostatin analogs as treatment for type i gastric neuroendocrine tumors.


Eligibility criteria:
inclusion criteria: * histologic diagnosis of gastric neuroendocrine tumor. * clinical diagnosis of type i gastric net: neuroendocrine tumor arising from atrophic body gastritis (abg diagnosis should be based on hypergastrinemia and histological confirmation of gastric body atrophy on multiple biopsies performed in gastric antrum and body). * previous esophagogastroduodenoscopy: all visible nets resected with r0 margin, confirmed no visible gastric nets left, multiple biopsies taken to evaluate gastric atrophy and ecl status. * no tumor metastases confirmed by endoscopic ultrasonography, ct scan or somatostatin receptor scintigraphy. * ssa therapy is recommended by physician for disease management, and has not yet begun. * written informed consent obtained prior to treatment to be consistent with local regulatory requirements. exclusion criteria: * pathological grading as g3 net (ki-67\>20%). * patients with a known hypersensitivity to somatostatin analogs. * known gallbladder or bile duct disease, acute or chronic pancreatitis. * known medical condition related with prolonged qt interval. * pregnant or lactating women. * patients with serious complicated infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy. * patients with any concurrent active malignancy other than non-melanoma skin cancers or carcinoma-in-situ of the cervix. patients with previous malignancies but without evidence of disease for \> 5 years will be allowed to enter the trial. * patients with a history of non-compliance to medical regimens.
serum pentraxin-3 in non-alcoholic fatty liver disease with or without hepatitis c virus

Conditions: Non Alcoholic Fatty Liver Disease

Summary: this study included 70 subjects divided into 3 groups. group i included 25 patients with nafld. group ii included 25 patients with nafld and chronic hcv. group iii: included 20 controls. abdominal ultrasound was done to patients and controls. plasma pentraxin-3 (ptx3) was measured using elisa. comparison between three groups was done regarding plasma pentraxin-3. higher levels of plasma ptx3 were detected in nafld patients irrespective of presence or absence of chronic hcv infection. plasma ptx3 could be used as a non-invasive test for prediction of metabolic syndrome in the high-risk population with high sensitivity and moderate specificity.


Eligibility criteria:
inclusion criteria: * patients with nafld. * patients with nafld and chronic hepatitis c viral infection. exclusion criteria: * current or past consumption of significant amount of alcohol more than 21 drinks and 14 drinks per week for men and women respectively. * patients receiving drugs which cause fatty liver as amiodarone, diliazem, tamoxifen, steroids. * patients who take statins as it has lowering effect on plasma ptx3. * patients having any clinical evidence of hepatic decompensation, such as hepatic encephalopathy, ascites, variceal bleeding, elevated serum bilirubin level to more than two folds the upper limit of normal. * patients with heart failure. * patients with autoimmune rheumatic disease. * patients with chronic kidney diseases. * patients with sepsis.
age-related differences in response to pituitary stimulation tests

Conditions: Pituitary; Aging

Summary: the purpose of this study to age-related differences to the response of a combined pituitary stimulation test with trh, lhrh and acth.

participants will be recruited in three different age intervals: 18-45 years, 55-80 years and 80+ years. these participants will all undergo the same stimulation test with 0.1 mg lhrh, 0.2 mg trh, and 0.25 mg acth (synachten). the tests will be perfomed at the same time of day for all particpants (between 08:15 and 08:45) and participants will be fasting for the test. blood samples will be taken just before and at 10, 20, 30, 45, 60, 90 and 120 minutes following the stimulation test. serum from blood samples will be stored at -20 degrees until analysis.

Eligibility criteria:
inclusion criteria: * ages between 18-45 or above 55. * healthy volunteers exclusion criteria: * medication or conditions affecting pituitary response (such as hormonal birth control, steriod use, thyroid disorders) * pregnancy or birth within the last year * inability to give informed consent
the effects of facial cooling on fencing performance

Conditions: Hyperthermia

Summary: fencing competitions can last between nine and eleven hours, during which athletes wear layers of protective equipment that impair evaporative heat transfer and spend a large amount of time at exercise intensities \> 85% maximum heart rate. fencing performance can potentially contribute to heat stress due to increases in core temperature. elevated core temperatures could hamper performance, and therefore the implementation of a strategy to reduce core temperature increases could lead to augmented fencing performance. cooling methods are limited for use between fencing matches and during short breaks within a direct elimination match. furthermore, due to multiple layers of thick protective equipment cooling method applications are limited primarily to the facial area. a potential cooling strategy, during fencing competition, includes the utilization of a water facial mist spray combined with fanning of the face. therefore, the aim of this study is to investigate the novel use of facial cooling on core temperature, relevant physiological parameters, perceived exertion and thermal comfort and sensation during a simulated fencing competition performance, in male epee fencers.


Eligibility criteria:
inclusion criteria: * trained fencers exclusion criteria: * injured or a contraindicative medical condition
a study of abemaciclib (ly2835219) in participants with stage iv squamous non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer Stage IV

Summary: the main purpose of this study is to evaluate the effectiveness of the study drug known as abemaciclib versus docetaxel in participants with stage iv squamous non-small cell lung cancer (nsclc) previously treated with platinum-based chemotherapy.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of stage iv nsclc. * have progressed during or after platinum-based chemotherapy for advanced disease. * have not received prior treatment with docetaxel. * have availability of adequate formalin-fixed paraffin-embedded (ffpe) tumor derived material. * have adequate organ function including hematology, renal, and liver. * have good performance score (0-1). * have measurable disease per recist 1.1. * agree to use a reliable medically approved method of birth control. exclusion criteria: * have received prior treatment with any cyclin dependent kinase (cdk) 4 and 6 inhibitor or participated in a clinical trial with a cdk 4 and 6 inhibitor and the treatment administered is not known. * are currently receiving treatment in a clinical trial involving an investigational product or non-approved use of a drug or device. * have the presence of unstable central nervous system (cns) metastasis. * have had major surgery (excluding biopsy) \< 28 days of the initial dose of study drug.

Keywords: patient reported outcomes (pro) patient focused outcomes (pfo) biomarkers cdk 4 and 6