Kornimate/medical-research-clean huggingface dataset:
study to evaluate the efficacy and safety of temozolomide in subjects with brain metastases of either malignant melanoma, breast, or non-small cell lung cancer (p02064)

Conditions: Metastases of Central Nervous System; Melanoma; Breast Neoplasm; Carcinoma, Non-Small-Cell Lung

Summary: the study implies a 2 step study design. patients are enrolled into 3 separate groups for melanoma, breast, and non-small cell lung cancer. in the first step, 21 patients per disease group are enrolled. if \>=2 objective responses (sd, pr, or cr) out of 21 evaluable patients are observed, enrollment continues for other 45 patients as a whole, where response will be positively evaluated if \>=10 patients will respond. if \<2 objective responses out of 21 evaluable patients per disease group are observed, this(ese) group(s) will no longer be treated with temozolomide.


Eligibility criteria:
inclusion criteria: * cytological/histological diagnosis of either melanoma, non-small cell lung cancer and breast; * brain metastases \>=1 cm presenting or in progression following \>=4 weeks time interval free from previous malignancy-specific chemotherapy, hormone therapy, or other medical therapies; * magnetic resonance imaging suspected brain metastases; patients with brain lesion(s) not univocal as brain metastases must have negative radiolabeled leukocyte brain scan to rule out infectious non-malignant disease; all neuroradiological studies (baseline and treatment outcome evaluation), except for emergency exams must be performed after 10 days of unchanged schedule of dexamethasone, and obtained in the axial-coronal-sagittal planes in t1 and t2 before and after gadolinium enhancement. * presence of al least one bidimensionally measurable and not previously irradiated metastasis. * age \<=70 years. * performance status 0-2 (ecog-who scale). * blood leukocytes \>=3.5 x 10\^9/l and platelets \>=100 x 10\^9/l. * bilirubin \<=25 m/l. * seric transaminases \<=2 x upper limit of normal values. * creatinine \ =60 ml/min. * signed written informed consent. exclusion criteria: * diabetes not allowing administration of adequate doses of dexamethasone at least during the first 2 months of treatment. * previous whole brain irradiation. * brain metastases eligible to neurosurgery or stereotactic radiation therapy. * previous or current malignancies at other sites with the exception of adequately treated in situ carcinoma of the cervix or basal and squamous carcinoma of the skin. * pregnant or nursing women. * acute infection requiring intravenous antibiotics. * severe vomiting or medical condition which could interfere with oral medication intake. * anticonvulsant chronic therapy.
phase iii study of apatinib tablets in the treatment of advanced or metastatic gastric cancer

Conditions: Advanced or Metastatic Gastric Cancer

Summary: apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor receptor (vegfr), and it's anti-angiogenesis effect has been viewed in preclinical tests. the investigators' phase i study has shown that the drug's toxicity is manageable and the maximum tolerable daily dose is 850 mg. the purpose of this study is to determine whether apatinib can improve progression free survival or overall survival compared with placebo in patients with metastatic gastric carcinoma who failed two lines of chemotherapy.


Eligibility criteria:
inclusion criteria: * ≥ 18 and ≤ 70 years of age * histological confirmed advanced or metastatic adenocarcinoma of the stomach * have failed for at least 2 lines of chemotherapy * life expectancy of at least 12 weeks. * eastern cooperative oncology group performance status of 0 or 1 within 1 week before randomization. * at least one measurable lesion beyond stomach (larger than 10 mm in diameter by spiral ct scan) * duration from the last therapy is more than 6 weeks for nitroso or mitomycin * more than 4 weeks for operation or radiotherapy * more than 4 weeks for cytotoxic agents or growth inhibitors * adequate hepatic, renal, heart, and hematologic functions (hb ≥ 90g/l,platelets \> 80 ×10 e+9/l, neutrophil \> 1.5 × 10 e+9/l, serum creatinine ≤ 1× upper limit of normal(uln), bilirubin \< 1.25× uln, and serum transaminase ≤ 2.5× uln). exclusion criteria: * pregnant or lactating women * history of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure \> 140 mmhg, diastolic blood pressure \> 90 mmhg). * any factors that influence the usage of oral administration; evidence of central nerves system(cns) metastasis * intercurrence with one of the following: coronary artery disease, arrhythmia ,heart failure and proteinuria ≥ (+) * international normalize ratio (inr) \> 1.5 and activated partial thromboplastin time（appt） \> 1.5 × uln * abuse of alcohol or drugs * certain possibility of gastric or intestine hemorrhage * less than 4 weeks from the last clinical trial * prior vegfr inhibitor treatment * disability of serious uncontrolled intercurrence infection objective evidence of previous or current pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, pulmonary function damaged seriously etc.
etiology of early apical peri-implantitis

Conditions: Early Apical Peri-implantitis

Summary: a case-control study was performed was performed following the strobe statement from 1996 to 2016 including patients who were diagnosed with early apical peri-implantitis. data were collected at the time of implant placement, and once the patients developed signs and symptoms consistent with early apical peri-implantitis, to determine the frequency and etiology of this pathology.

a case-control study was performed following the strobe statement (17) at the oral surgery department, faculty of medicine and dentistry (university of valencia, spain) from 1996 to 2016, in which patients with early peri-implantitis diagnosed were included (figure 1). all patients were informed about the study design and procedures. prior to participating, they were requested to sign an informed consent document. the study design was approved by the ethical committee of the university of valencia (h1478255958653). two groups were established: test group (patients diagnosed with early apical peri-implantitis diagnosed) and control group (patients whose implants had not developed any inflammatory/infectious process and were osseointegrated).

Eligibility criteria:
inclusion criteria: * the following inclusion criteria were applied: patients ≥18 years old and controlled medical conditions who received treatment with implants. additionally, for the test group, inclusion criteria were: symptoms and signs suggesting early apical peri-implantitis after implant placement; absence of implant mobility; dull percussion of nonsurmerged implants; presence or absence of radiolucency apically. exclusion criteria: * for the both groups: implants placed with guided bone regeneration or inadequate follow-up for failing to maintenance visits.

Keywords: "early apical peri-implantitis"; "implant periapical lesion"; "retrograde peri-implantitis"; "implant failure"
effects of letrozole during the luteal phase after controlled ovarian stimulation in oocyte donors.

Conditions: Luteinised Follicular Cyst

Summary: the objective of this trial is to determine whether the use of letrozole during the luteal phase in oocyte donors diminishes the ovarian volume, as well as to evaluate its effect on the duration of the luteal phase, taking into account hormonal and biochemical markers. two groups will be established with random allocation of patients and 1:1 proportionality, as follows: * control group: no specific treatment. * study group: oral administration of letrozole 5 mg (each capsule is 2.5 mg) once a day for 5 days starting on the night of the follicular puncture.

letrozole is a widely used drug in the context of hormone-dependent malignant tumors due to its antiestrogenic effect. its mechanism of action allows its application to the field of assisted reproductive medicine, mainly as an inductor of ovulation, by means of a blockage in the negative feedback signalization of the hypothalamus-pituitary-gonadal axis. in the last years, it has also been tested with the goals of preventing ovarian hyperstimulation syndrome (ohss) or analyzing its effects on several endocrinological and biochemical markers such as lh, progesterone or vegf. however, the results are inconsistent on every account. data regarding the effect on ovarian size and the duration of the luteal phase following the administration of letrozole after the oocyte pick-up can be useful to evaluate the benefit of this drug in patients with a tendency towards hyperresponse, in which both the discomfort after the stimulation and the risk of ovarian torsion are increased. the objective of this trial is to determine whether the use of letrozole during the luteal phase in oocyte donors diminishes the ovarian volume, as well as to evaluate its effect on the duration of the luteal phase, taking into account hormonal and biochemical markers

Eligibility criteria:
inclusion criteria: * hyper-responsiveness to stimulation, defined as the presence of ≥18 follicles of size ≥11 mm (22-24) on the day of the last ultrasound visit prior to ovarian puncture. exclusion criteria: * participation in another clinical study, prior to inclusion in the present study, that could affect the objectives of this study. * known allergy to letrozole. * known lactose intolerance.
effect of menstrual cycle on traumatic systemic response

Conditions: Systemic Inflammatory Response Syndrome

Summary: it is aimed to evaluate pathophysiology of systemic responses to trauma via using interleukin (il) -1 and il-6 levels and determining timing of surgery through phases of menstrual cycle.

89 female breast cancer patient who underwent modified radical mastectomy included into study. menstrual history and hormone levels were used to determine menstrual phase: luteal, follicular, and other. il-1β and il-6 levels, which are related to severeness of inflammation, were measured one day before and one day after surgery. those are statistically analysed to show effect of timing of breast surgery on responses to trauma in postmenopausal and premenopausal women during different phases of their menstrual cycles

Eligibility criteria:
inclusion criteria: * female patients * who underwent modified radical mastectomy for breast cancer * who signed informed consent forms exclusion criteria: * for premenopausal patients taking oral contraceptives * for postmenopausal patients taking hormone replacement therapy.

Keywords: breast cancer menstrual cycle breast surgery systemic responses to trauma
the efficacy of bedside respiratory muscle training in stroke patients

Conditions: Stroke; Rehabilitation; Breathing Exercise; Pneumonia; Respiration

Summary: objectives: to investigate the efficacy of bedside respiratory muscle training on pulmonary function and stroke-related disabilities in stroke patients. design: prospective randomized controlled trial setting: a single physical medicine and rehabilitation department at a university hospital participants: stroke patients in a rehabilitation unit were recruited and randomly assigned to either the intervention group or the control group. intervention: both groups participated in a conventional stroke rehabilitation program. during the study period, the intervention group received bedside respiratory muscle training twice a day for three weeks. the respiratory muscle training consisted of (1) a breath stacking exercise, (2) inspiratory muscle training and (3) expiratory muscle training. the participants were evaluated at baseline and again at the end of the study (3 weeks later). main outcome measures: the primary outcomes were measures of pulmonary function: functional vital capacity (fvc), forced expiratory volume in one second (fev1) and peak flow. secondary outcomes were stroke-related disabilities assessed by the following: national institutes of health stroke scale, modified barthel index, berg balance scale, fugl-meyer assessment, the korean mini-mental state examination, and the incidence of pneumonia.


Eligibility criteria:
inclusion criteria: 1. older than 18 years of age, 2. first episode of stroke within three months, 3. moderate to severe stroke impairment, defined as a nihss score from 5-36, and 4. the ability to follow instructions and engage in the study program. exclusion criteria: 1. a medical history of persistent cardiopulmonary disease, 2. other coexisting brain disorders, such as brain tumor, 3. poorly controlled hypertension, which was defined as a blood pressure higher than 180/100 mmhg during the preceding 24 hours, 4. severe facial palsy or other oropharyngeal structural abnormality, 5. severe oral apraxia, and (6) having a tracheostomy.
clinical and neuromechanical predictors for the evolution of chronic non-specific low back pain

Conditions: Low Back Pain

Summary: the purpose of the present study is to determine the association between factors known to be associated with the development of chronic low back pain (psychological and biological) and the evolution of functional disability in individuals with a history of low back pain. to do so, 100 individuals with a history of nonspecific low back pain will be followed over a period of 18 months. during this time frame, participants will be evaluated three times in the laboratory (initial, at 6 months and at 18 months) to determine pain and tolerance thresholds, pain inhibition processes as well as neuromuscular activation. moreover, these participants will be assessed every three months (initial, 3, 6, 9 12, 15 and 18 months) for functional disability and pain intensity levels of their low back pain as well as for psychological symptoms usually associated with the development of chronic low back pain. it is hypothesized that high psychological symptoms measured initially will be associated with high functional disability throughout the study .


Eligibility criteria:
inclusion criteria: * to have experienced at least one episode of disabling (resulting in loss of work or modified tasks at work) nonspecific low back pain in the past three years. exclusion criteria: * specific causes of low back pain, arthritic conditions, other chronic pain conditions

Keywords: psychological factors functional disability pain thresholds tolerance thresholds motor adaptations natural course
use of methacetin breath test to predict liver failure in patients with cirrhosis

Conditions: Cirrhosis

Summary: the methacetin breath test (mbt) is a non-invasive liver function test which measures the ability of the liver to metabolize a tracer dose of a compound to carbon dioxide, which is exhaled. the study hypothesis is that measurement of the mbt will allow earlier detection of a decline in liver function in patients with cirrhosis who are awaiting liver transplantation.


Eligibility criteria:
inclusion criteria: 1. being considered for placement or already on the liver transplantation waiting list 2. cirrhosis caused by any cause of chronic liver disease. 3. age \> 18 years exclusion criteria: 1. known or suspected hepatocellular carcinoma 2. prior tips placement 3. severe congestive heart failure 4. severe pulmonary hypertension 5. uncontrolled diabetes mellitus (hba1c \>9.5%) 6. any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication. 7. previous surgical bypass surgery for morbid obesity (bmi \>45) 8. extensive small bowel resection 9. patients currently receiving total parenteral nutrition if they have contraindications to oral drugs 10. women who are pregnant 11. patients who are allergic to acetaminophen/ paracetamol or any other related medications 12. patients with an acute current exacerbation of chronic obstructive pulmonary disease or bronchial asthma. 13. patients that are taking hepatotoxin drugs 14. patient, based on the opinion of the investigator, should not be enrolled into this study 15. patient is unable or unwilling to sign informed consent. 16. patients that are participating in other clinical trials evaluating experimental treatments or procedures
predicting developmental disability type and mental retardation level in children with general developmental delay

Conditions: Global Developmental Delay; Cerebral Palsy; Mental Retardation; Pervasive Developmental Disorders

Summary: the purpose of this study is to find the relationship between the stage and quality of developmental delay during infancy and toddler age, and the final diagnosis that the child gets a few years later (mr, type of pdd, cp or comorbidity of a few disorders).

the purpose of this study is to find the relationship between the stage and quality of developmental delay at a young age, and the final diagnosis that the child gets a few years later (mr, type of pdd, cp or comorbidity of a few disorders). we assume that analysis of developmental subtests can show the developmental direction of the child and predict his later diagnosis. the developmental test which is chosen for this purpose is the bsid which is a comprehensive and worldwide developmental test. in addition, we want to find the correlation between the developmental delays in early age and the intellectual functioning in the future. we assume that through analyzing the subtests of developmental tests we will succeed in predicting the expected cognitive level (iq). medical files of participating children will be analyzed. the files will be sorted and only those of gdd diagnosis containing bsid test data will be selected. the performances of the bsid test and the current diagnosis of the children will be recorded. a trained researcher will process the bsid data and build a database which will include the findings of the test, the current diagnosis of the child and the level of mr, in case the child suffers from mr (only or comorbidly). in order to test the research assumptions appropriate statistic tests will be done using the statistical program spss version 17. this study has important implications. findings which show that the developmental tests are effective tools, not only to evaluate general developmental delay, but as auxiliary tools for diagnosing and predicting the type of disability and level of retardation. these findings are a breakthrough in the diagnostic field. in addition, the ability to predict the type of disability and level of mental retardation by a developmental test that is used so widely allows early intervention, and as has been widely proven, the earlier the intervention, the better the outcome. in addition, a vast range of people will benefit from the findings. professionals such as doctors, psychologists and paramedical therapists, government bodies and community resources that can design and build a support system and services for the child and his family. most importantly, the family of the diagnosed child and the child himself will be able to prepare themselves to the new reality and design their life accordingly.

Eligibility criteria:
inclusion criteria: * gdd diagnosis in two axis' at least * bsid test in its second or third version exclusion criteria: * if not all of the data is available for all of the assessments

Keywords: gdd cp mr pdd asd bsid
targeted rehabilitation to improve outcome after knee replacement- a physiotherapy study

Conditions: Osteoarthritis of the Knee

Summary: the trio-physio study is looking at how well patients with osteoarthritis recover after knee replacement surgery (also known as total knee arthroplasty (tka)). currently around 20% of patients are not satisfied after tka. this project will look to find out if the research team can identify patients who will not recover well at an earlier stage, so that these patients can be helped sooner. the study will try to determine if doing intense physiotherapy with patients who are not doing well at the first review (6 weeks after their operation) can improve how well they have recovered at one year.

the study is a randomised controlled trial comparing the effect of intensive physiotherapy compared to current standard of care therapy, targeted to patients performing poorly at 6 weeks following total knee replacement. all patients will be made aware of the study pre-operatively at the recruiting centres. prior to surgery they will complete the routine pre-operative outcome assessment questionnaires (oxford knee score and eq-5d) as part of the national proms program and then undergo the local standard total knee replacement and immediate post-operative care pathway. all patients will be routinely reviewed 6 weeks post-operatively by the usual clinical teams. at this review the oxford knee score will again be assessed. those patients who report a score of 26 or less (on the 0-48 oks scoring system), which is defined as poor by the kalairajah classification (kalairajah, 2005), will be approached to consent. if consent is given and the patient is eligible to enter the trial, randomisation into one of the following groups will occur: to standard care (encompassing a one off physiotherapy review, 6 weeks of home exercise prescription and final review) or to an interventional arm, where 18 sessions of structured physiotherapy will be administered over a 6 week period, where 6 of these sessions will be 'contact sessions' performed under the supervision of the physiotherapist. all trial participants will be reviewed immediately post intervention (i.e. at 14 weeks post operation) and then by postal questionnaire at 26 and 52 weeks post-operation.

Eligibility criteria:
inclusion criteria: * undergoing primary total knee arthroplasty for osteoarthritis. * defined poor outcome (oxford knee score less than or equal to 26) at first post-op review (6 weeks). * patients are able to consent and willing to comply with the study protocol exclusion criteria: * patients undergoing revision knee arthroplasty or fully constrained knee arthroplasty * knee replacement for a diagnosis other than osteoarthritis * patients unable to attend the study physiotherapy intervention centre * procedures done purely for pain relief (such as for patients with no walking capacity) * patients already receiving ongoing structured post-operative exercise rehabilitation