Kornimate/medical-research-clean huggingface dataset:
an observational study to assess safety and outcome of the various medication usage patterns in clinical routine practice in patients receiving lenalidomide.

Conditions: Multiple Myeloma

Summary: the study is designed as a prospective, non-interventional, observational single arm study. hundred-fifty patients over 18 with stable disease or at least partial response while on treatment with lenalidomide will be recruited from approximately 20 haematology/oncology sites in the netherlands. recruitment will continue until 150 patients have started the study. when this target is reached, all patients on lenalidomide will continue to be followed until the last patient has been followed for 36 months.


Eligibility criteria:
inclusion criteria: * patients over 18 years of age who understand and voluntarily sign an informed consent form. * patients with multiple myeloma who are currently receiving lenalidomide treatment and who have taken lenalidomide for \> 2 cycles and \< 6 cycles. * patients with currently stable disease or meeting the criteria for complete response, very good partial response or partial response while on lenalidomide treatment. exclusion criteria: * refusal to participate in the study. * women who are pregnant or breast-feeding. * women of childbearing potential unless all of the conditions of the pregnancy prevention programme are met. * hypersensitivity to the active substance or to any of the excipients.

Keywords: myeloma non-interventional observational lenalidomide review post-authorization netherlands
the efficiency of msc in refractory crohn's disease

Conditions: Crohn's Disease

Summary: the investigators' preliminary study indicates that msc is effective therapy in treating ibd. but the standard treatment is still lacking and the effect is not stable in ibd patients. this study is to explore the efficacy and standard strategy when using msc in refractory ibd.


Eligibility criteria:
inclusion criteria: * failure or intolerance to gc, immune inhibitors and biological agents treatment * cdai between 250-450 * weight between 40-150 kg * normal renal function * endoscopic or imaging diagnosis of cd in the small intestine, colon ileocolon * signed informed consent exclusion criteria: * hiv or active hepatitis patients; * allergic to ct contrast agents, cattle or pig products; * stricture or perforation type cd; * recieved permanent colostomy; * used biological preparation in 3 months * used prednisone \> 20 mg/day within 1 month ; * patients with short bowel syndrome; * need total parenteral nutrition; * liver meritorious service is abnormal; * suffering from malignant tumor during the last 5 years; * combined bacterial or viral enteritis; * suffering from intestinal typicality thickening of the living * patients with tuberculosis.

Keywords: efficacy of msc refractory
pituitary gland stimulation for cancer pain relief

Conditions: Oncology Pain

Summary: patients will undergo an implantation of an extradural pituitary surface electrode in the pituitary fossa. the electrode will be attached to a neurostimulator via which the patient will receive up to 8 (patient requested) stimulations per day.


Eligibility criteria:
inclusion criteria: * adult patient * in palliative phase of metastatic disease, without options for further systemic treatment or radiotherapy * inadequately controlled pain with standard care * most prominent part of experienced pain is nociceptive * karnofsky performance score ≥30 exclusion criteria: * not fit for general anesthesia * pregnancy * unfavorable local anatomy for pgs, due to a disease process, or anatomical configuration * clinical signs of posterior pituitary gland disfunction * recent history of alcohol or drug abuse * severe immunodeficiency * need for anticoagulation therapy that cannot be abrogated for surgery * need for subsequent mri-imaging * cognitive impairments prohibiting full understanding of study and ability to provide informed consent * not able to adequately communicate in dutch or english
the telemonitoring in the management of heart failure (tema-hf) 1 long-term follow-up study

Conditions: Telemonitoring in Coronary Artery Disease

Summary: tema-hf 1 long-term follow-up study is a follow-up study of tema-hf 1. it assessed the long-term impact of a 6-months telemonitoring program in chronic heart failure patients.

the telemonitoring (tm) group patients received a 6-months tm program, followed by standard heart failure care until the long-term follow-up evaluation. the usual care (uc) patients received ususal care during the first six months, followed by standard heart failure care until the long-term follow-up evaluation.

Eligibility criteria:
inclusion criteria: * chronic heart failure patients * treated for heart failure according to current guidelines * ≥ 18 years of age * able to provide informed consent exclusion criteria: * reversible forms of acute heart failure (myocarditis) * presence of severe aortic stenosis * previous residency in a nursing home * inclusion in a cardiac rehabilitation program on discharge * chronic kidney disease stage ≥ 4 * planned dialysis in the next six months * life expectancy \< 1 year due to non-heart failure related reasons * severe chronic obstructive pulmonary disease, gold ≥ iii * cognitive and/or mental problems interfering with the performance of daily measurements and data transmission

Keywords: telemonitoring chronic heart failure ehealth mortality
pgt-a in screening of embryos in the treatment of unexplained recurrent miscarriage

Conditions: Recurrent Early Pregnancy Loss

Summary: urm patients selected pgt-a from 2012 to 2016 were included in this study. their clinical outcomes were prospectively observed and analyzed to explore the factor influenced the outcomes.

this prospective observational study enrolled all women with urm who underwent array-comparative genomic hybridization (array-cgh) for pgt-a in the reproductive medicine center of peking university third hospital from 2012 to 2016. if a couple underwent multiple stimulation cycles during the research period, only the first cycle was included. all patients underwent adequate clinical and genetic consultations before undergoing pgt-a, and all voluntarily chose pgt-a after fully understanding its risks and benefits. all patients signed the informed consent document of pgt-a. all included stimulation cycles involved intracytoplasmic sperm injection insemination. after successfully fertilized embryos formed blastocysts on day 5-7, trophoblasts were biopsied to determine embryonic karyotypes. the blastocysts with normal/balanced test results were cryopreserved, whereas abnormal blastocysts were discarded after notifying the patients. all normal blastocysts from a patient were thawed and transferred singly, and the outcomes of all subsequent frozen-thawed embryo transfer cycles were followed-up until january 2020. clinical outcomes included the blastocyst formation rate, the proportion of blastocysts with normal karyotypes, and the clinical pregnancy, live birth, and cumulative live birth rates. the factors that affected these clinical outcomes were analyzed to predict outcomes and guide treatment in women with urm.

Eligibility criteria:
inclusion criteria: women with urm who underwent array-comparative genomic hybridization (array-cgh) for pgt-a in the reproductive medicine center of peking university third hospital from 2012 to 2016.only the first cycle was included. all patients underwent adequate clinical and genetic consultations before undergoing pgt-a, and all voluntarily chose pgt-a after fully understanding its risks and benefits. all patients signed the informed consent document of pgt-a. exclusion criteria: couples with parental chromosomal abnormalities were excluded, as were women with anatomical abnormalities of the uterus, autoimmune diseases, and endocrine abnormalities.
the study of human atherosclerosis by polarization-sensitive optical coherence tomography

Conditions: Pathological Conditions, Anatomical

Summary: atherosclerosis is unquestionably the leading cause of morbidity and mortality in developed countries, and the world-wide importance of acute vascular syndromes is increasing. rupture of atherosclerotic plaque has been identified as the proximate event in the majority of cases of acute ischemic syndromes. therefore, modalities capable of characterizing the atherosclerotic lesion may be helpful in understanding its natural history and detecting lesions with high risk for acute events. optical coherence tomography (oct) is a powerful tool capable of tomographic imaging based on low coherence interferometry. it is analogous to ultrasound imaging except that it uses infrared light instead of sound. polarization-sensitive optical coherence tomography (ps-oct) combines the advantages of oct with additional image contrast of the sample. the added contrast is based on the ability of ps-oct to detect the birefringent properties of a sample (phase retardation and fast-axis orientation) simultaneously. the goals of this project are: 1) to examine whether ps-oct is an acceptable tool for the characterization of typical plaque constituents; and 2) to explain the correlation between birefringence and forming or rupture of a plaque; and 3) to establish a quantitative ps-oct image criteria for atherosclerotic plaque characterization in vitro.

optical coherence tomography (oct) is a promising new class of diagnostic medical imaging technology that utilizes advanced photonics and fiber optics to obtain images and tissue characterization on a scale never before possible within the human body. oct combines the principles of ultrasound with the imaging performance of a microscope and a form factor that is familiar to clinicians. whereas ultrasound produces images from backscattered sound "echoes," oct uses infrared light waves that reflect off the internal microstructure within the biological tissues.

Eligibility criteria:
inclusion criteria: * heart transplantation, atherosclerosis exclusion criteria: * infection

Keywords: atherosclerosis optical coherence tomography polarization phase retardation birefringence
multi-centre clinical evaluation of two daily disposable contact lenses

Conditions: Myopia

Summary: the purpose of this study is to compare the subjective performance for handling of two daily disposable contact lenses, stenfilcon a and etafilcon a.

the study is to compare the subjective performance for handling of two daily disposable contact lenses, stenfilcon a and etafilcon a in this cross-over study.

Eligibility criteria:
inclusion criteria:- * be between 16 and 45 years of age (inclusive) * adapted soft contact lens (cl) wearers (i.e. \> 1 month) * spherical distance cl prescription between -1.00 and -6.00d (inclusive) * spectacle cylinder ≤0.75d in the least astigmatic eye, ≤1.00d in the other. * correctable to 6/9 (20/30) in both eyes * have the use of a mobile phone to send and receive text messages throughout the day for the duration of the study. * have read, understood and signed the informed consent * willing to comply with the wear schedule (at least 40 hours per week) * willing to comply with the study visit schedule exclusion criteria:- * any active corneal infection, injury or inflammation * systemic or ocular allergies, which might interfere with cl wear * systemic disease, which might interfere with cl wear * ocular disease, which might interfere with cl wear * strabismus, amblyopia * subjects who have undergone corneal refractive surgery and any anterior segment surgery * subjects with keratoconus or other severe corneal irregularity contraindicating lens wear * pregnant or lactating * use of systemic/topical medication contraindicating cl wear * use of gas permeable contact lenses within the last month * employees of the investigational site or immediate family members of investigators * participation in any concurrent clinical trial or in the last 30 days
anidulafungin candidemia/invasive candidiasis intensive care study

Conditions: Invasive Candidiasis

Summary: to evaluate the efficacy and safety of anidulafungin in the treatment of systemic fungal infections in intensive care and critical care unit patients.


Eligibility criteria:
inclusion criteria: icu patients with a diagnosis of documented candidemia or invasive candidiasis and belonging to one or more of the following specific populations: * post-abdominal surgery. * elderly \> 65 years old. * renal insufficiency / failure / hemodialysis. * solid tumor. * solid-organ (liver, kidney, lung, heart) transplant recipients. * hepatic insufficiency. * neutropenic including hematology oncology patients. exclusion criteria: patients with poor venous access that would preclude iv drug delivery or multiple blood draws.

Keywords: candida candidemia systemic candidiasis icu intensive care unit critical care unit anidulafungin ecalta eraxis fluconazole voriconazole
open-label extension assessing long-term safety of rosiglitazone in subjects with mild to moderate alzheimer's disease

Conditions: Alzheimer's Disease

Summary: this is an open-label extension to study 49653/461, to assess the long-term safety of rosiglitazone (extended release tablets) in subjects with mild to moderate alzheimer's disease.


Eligibility criteria:
inclusion criteria: * male or female subject who has successfully completed the 12 month visit of 49653/461 (12 months of treatment) without tolerability issues, where in the opinion of the subject and of the investigator, it will be beneficial to continue treatment with rsg xr. * female subjects must be post-menopausal (i.e. \>6 months without menstrual period), surgically sterile, or if of child-bearing potential, using effective contraceptive measures (oral contraceptives, norplant, depo-provera, an intra-uterine device (iud) a diaphragm with spermicide or a condom with spermicide). women of childbearing potential must use effective contraceptive measures throughout the study and for 30 days after discontinuing study medication. the subject and their caregiver must ensure that the subject will continuously use contraceptive measures throughout the duration of the study. * subject is willing to participate in the extension study and has provided full written informed consent prior to the performance of any protocol-specified procedure; or if unable to provide informed consent due to cognitive status, full written informed consent on behalf of the subject has been provided by a legally acceptable representative\[1\].\[1\] where this is in accordance with local laws, regulations and ethics committee policy. * caregiver has provided full written informed consent on his or her own behalf prior to the performance of any protocol-specified procedure. exclusion criteria: * subject had a serious adverse experience (sae) or clinically significant laboratory abnormality during 49653/461, which in the opinion of the investigator could have been attributable to study medication, and which is ongoing at the end of 49653/461. * the subject is felt by the investigator to be unsuitable (on the basis of health, compliance, caregiver availability, or for any other reason) for inclusion in the study based on the entry criteria for the primary study, 49653/461 (exclusive of the age criteria which may not be applicable to some of the subjects). * the subject experienced a significant cardiovascular event during 49653/461 (e.g. intervention, percutaneous coronary intervention, vascular surgery, acute coronary syndrome \[non q-wave myocardial infarction, q-wave myocardial infarction, unstable angina\] or significant arrhythmia), unless a thorough cardiovascular evaluation has been performed which confirms that the subject does not have congestive heart failure, and is clinically stable. * treatment with a cholinesterase inhibitor, selegiline, memantine or any other treatment for cognitive symptoms/ad is initiated at the end of 49653/461.

Keywords: alzheimer's disease rosiglitazone
time-dependent improvement of functional outcome following oxford medial unicondylar knee replacement

Conditions: Osteoarthritis

Summary: the objective of this prospective study is to determine (1) the time course of patient-relevant functional outcome evaluated by the knee injury and osteoarthritis outcome score (koos) and (2) the time course of range of motion (rom) the first six years following oxford medial unicondylar knee prosthesis. improvement of patient self-reported pain and daily function during the study period, are of particular interest.

the objective of this prospective study is to determine (1) the time course of patient-relevant functional outcome evaluated by the knee injury and osteoarthritis outcome score (koos) and (2) the time course of range of motion (rom) the first six years following oxford medial unicondylar knee prosthesis. improvement of patient self-reported pain and daily function during the study period, are of particular interest. thats it!

Eligibility criteria:
inclusion criteria: * patients with medial knee osteoarthritis * admitted for unicondylar knee replacement * age 50-80 years exclusion criteria * rheumatoid arthritis * previous knee infection

Keywords: unicondylar knee replacement
a phase iiib, multinational, multicenter, open-label extension study assessing the long-term safety of prn intravitreal injections of de-109 in subjects with non-infectious uveitis of the posterior segment of the eye who have participated in the sakura development program

Conditions: Non-Infectious Uveitis of the Posterior Segment of the Eye

Summary: the objective of this extension study is to evaluate the long-term safety of treatment with de-109 (440 μg) in subjects with non-infectious uveitis of the posterior segment of the eye who have participated in the sakura development program.

this is a multicenter, open-label, extension study of intravitreal injections of the 440 μg dose of de-109 in subjects with non-infectious uveitis of the posterior segment who received any dose of de-109 and exited the sakura program under santen protocol 32-007, amendment 05. subjects who were randomized and received at least two injections of de-109 during the first five months of the sakura program and obtained clinical benefit from the study medication, as determined by the investigator, may be considered for entry in this 12-month extension study. the minimum time lag from last injection in the sakura program to entry into the current protocol is 60 days.

Eligibility criteria:
inclusion criteria: 1. participated in the sakura study 2. received clinical benefit from treatment in the sakura study 3. ability to sign informed consent and attend all study visits exclusion criteria: 1. uveitis of infectious etiology 2. implanted device 3. suspected or confirmed central nervous system or ocular lymphoma 4. uncontrolled glaucoma 5. significant ocular disease 6. intravitreal injections in the past 60 days 7. intraocular surgery or treatment 8. ocular or periocular infection 9. history of herpetic infection 10. toxoplasmosis or toxoplasmosis scar 11. ocular malignancy 12. vitrectomy 13. allergy or hypersensitivity to study drug 14. participation in other uveitis device clinical trials within 30 days 15. any recent systemic condition/infection 16. immunosuppressive therapy or immunocomprimised 17. cytomegalovirus infection 18. malignancy in remission 19. females who are pregnant or lactating and who are not using adequate contraceptive 20. medical marijuana or illegal drug use 21. systemic saroidosis 22. therapeutic radiation to the head or neck
analysis of genomic dna alterations in familial schizophrenia

Conditions: Schizophrenia

Summary: persons with schizophrenia experience imaginary voices, visions and disorganized thoughts, and are handicapped when it comes to social life, which is detrimental to the affected individuals and the community. although the pathogenesis of this mental disease has not been clearly elucidated, much evidence suggests that inheritance is of major etiological importance and multiple genetic components are implicated. previous linkage studies of familial schizophrenia have led to the successful identification of numerous susceptibility loci covering many of the human chromosomes, including chromosome 1q, 5q, 6p22, 6p24, 8q21, 13q32, 15q13-14 and 22q11, etc. necessities for further identification of candidate genes involved in familial schizophrenia by taking a genome-wide approach are listed as follows: 1. given that multiple genes are responsible for this disease, it is of critical interest to view the complete molecular profiling of schizophrenia's genome; 2. identification of promising schizophrenia candidate genes by genome-wide scanning will facilitate the development of molecular markers and provide a more objective and effective assessment method in psychotic diagnosis and prognosis; 3. prevention of the onset of this disorder will be improved by early classification of individuals bearing strong genetic loading for schizophrenia as a high risk population; 4. making a breakthrough into the investigation of schizophrenia pathogenesis by the characterization of susceptible genes found by genome-wide exploring. array-based comparative genomic hybridization (cgh) allows high-throughput genome-wide survey for dna copy number aberrations, providing a powerful tool for investigating genetic disorders and for developing diagnostic and therapeutic targets. arrays used in this study consist of approximately 43,000 60-mer oligonucleotide probes that span coding and noncoding regions of the whole human genome with an average spatial resolution of around 35 kb. furthermore, the sensitivity of these arrays is capable of detecting and mapping regions of single-copy losses, homozygous deletions, and amplicons of various sizes even when using full-complexity genomic samples. in this study, the investigators will conduct an array-based comparative genomic hybridization (cgh) with genomic dna of many affected members from "schizophrenia families" (the investigators classified families according to the presence or absence of two or more affected members) to identify a set of candidate genes associated with this disease. it is hoped that the results obtained from this study will improve the accuracy and efficiency of psychotic treatment.


Eligibility criteria:
inclusion criteria: * familial schizophrenia * over 9 years of education

Keywords: schizophrenia multiple genes array-comparative genomic hybridization (cgh) genomic dna chinese han people
study comparing product 0405 to a vehicle control in the treatment of mild to moderate atopic dermatitis in pediatric subjects

Conditions: Atopic Dermatitis

Summary: the purpose of this study is to evaluate the safety and efficacy of product 0405 in pediatric subjects with mild to moderate atopic dermatitis.

treatment medication will be administered topically twice daily for 28 days

Eligibility criteria:
inclusion criteria: * clinical diagnosis of atopic dermatitis * good health with the exception of atopic dermatitis * percent body surface area minimum requirements exclusion criteria: * subjects who are pregnant, nursing or planning a pregnancy