Kornimate/medical-research-clean huggingface dataset:
risk minimisation study for diane-35 and its generics

Conditions: Acne Vulgaris

Summary: the study will be an observational, cross-sectional study of knowledge, understanding, and self-reported behavior among a sample of physicians with recent experience in prescribing diane-35 or its generics in a total of five european countries. the primary objective of this study is to measure physician knowledge and understanding of the key information contained in the diane-35 educational material: patient information card, and prescribers' checklist. specifically, the following objectives will be addressed: * investigate whether physicians have received any educational material related to diane-35 or its generics * assess physicians' knowledge and understanding of key safety information pertaining to the patient information card * assess physicians' knowledge and understanding of key safety information pertaining to the following areas: * contraindications relevant to thromboembolism * risk factors for thromboembolism * signs and symptoms of thromboembolism


Eligibility criteria:
inclusion criteria: -physicians eligible to participate will have recently prescribed (e.g., within previous 6 months) diane-35 or its generics
sterile inflammation and molecular aberrations in mds

Conditions: Myelodysplastic Syndromes

Summary: the objective of this study is the description of the possible association between genetic mutation/aberration profiles, inflammatory tonus and clinical phenotype based on proms and hrqol. apart from gaining a better understanding of the causal correlation between genetics, sterile inflammatory processes and qol (e.g. fatigue) in mds, this study is supposed to identify potential novel biomarkers and, ultimately, therapeutic targets.


Eligibility criteria:
inclusion criteria: * female and male patients \> 18 years * mds, mds/mpn diagnosis based on current who classification. ccus and chip defined by valent (valent, oncotarget, 2018) and by stauder (stauder, blood, 2018) * signed and dated declaration of consent by the patient according to ich-gcp guidelines exclusion criteria: * any other illness, whether physical or mental, or any laboratory abnormalities which prevent a declaration of consent by the patient * patients with an acute and/or uncontrolled infection, including patients that are afebrile under treatment with antibiotic/antifungal/antiviral prophylactic medication * any pre-existing autoimmune disease requiring a systemic immunosuppression * steroid therapy (\>10mg prednison/day or equivalent), regardless of its necessity up to 4 weeks before inclusion in the study * anamnestic and/or current therapy with hypomethylating agents (hma) or immunomodulatory imide drugs (imids) * status post allogenic stem cell transplantation * previous or ongoing chemotherapy * pregnancy or breastfeeding period

Keywords: anemia health-related quality of life inflammation
caelyx in ovarian cancer: prevention and treatment of infusion reactions and palmar-plantar erythrodysesthesia (study p04085)(completed)

Conditions: Ovarian Neoplasms

Summary: the purpose of this study is to evaluate the safety and tolerability of caelyx in women with advanced ovarian cancer, focusing on infusion reactions and palmar-plantar erythrodysesthesia.

this observational program is aimed at gaining tolerability and safety data with the routine use of caelyx in its labelled indication in ovarian cancer, focusing on infusion reaction and ppe. data will be raised about the premedication routinely used for the prevention of side effects caused by caelyx. premedications for infusion reactions include corticosteroids, serotonin 3 (5ht3) antagonists, histamine 1 (h1) blockers, and histamine 2 (h2) blockers. premedications for ppe include oral dexamethasone and vitamin b6. the management of infusion reactions and ppe will be recorded. a detailed record of the medical history may reveal patient groups at a higher risk of experiencing these side effects.

Eligibility criteria:
inclusion criteria: * women with advanced ovarian cancer with: * previous platin/taxane therapy and documented measureable and/or evaluable advanced or metastatic cancer by radiological imaging or increase of serum cancer antigen 125 (ca 125) according to rustin et al. exclusion criteria: * patients that are not treated according to the austrian summary of product characteristics (spc)
genetic basis of idiopathic focal epilepsies with cognitif deficits

Conditions: Epilepsy

Summary: epilepsy is a frequent neurological disease in childhood, characterized by recurrent seizures and sometimes with major effects on social, behavioral and cognitive development. childhood focal epilepsies particularly are age-related diseases mainly occurring during developmental critical period. a complex interplay between brain development and maturation processes and susceptibility genes may contribute to the development of various childhood epileptic syndromes associated with language and cognitive deficits. indeed, the landau-kleffner syndrome (lks), the continuous spike-and-waves during sleep syndrome (csws), and the benign childhood epilepsy with centrotemporal spikes (bcects) or benign rolandic epilepsy, are different syndromes that are considered as part of a single continuous spectrum of disorders. while genetic component in those three syndromes remains elusive, novel and high throughput genome analyzes could bring interesting insights into the possible genetic defects and pathophysiological mechanisms underlying and linking the various disorders associating epilepsy with speech and cognitive impairments.


Eligibility criteria:
inclusion criteria: * iodiopathic focal epilepsy with cognitif deficit exclusion criteria: * medical history of status epilepticus

Keywords: benign childhood epilepsy
the effect of ketamine on immune function and prognosis in patients undergoing colorectal cancer resection

Conditions: Colorectal Cancer

Summary: systemic inflammation caused by surgery may aggravate immunosuppression in immunocompromised cancer patients. the natural killer (nk) cell is a critical part of anti-tumor immunity. ketamine, a n-methyl-d-asparate receptor antangonist, has anti-inflammatory activity and opioid-sparing effect. this study investigate the effect of intraopertaive ketamine administration on immune function in patients undergoing laparoscopic colorectal cancer resection.


Eligibility criteria:
inclusion criteria: * patient between 20 and 80 of age with asa physical status ⅰ-ⅲ * patient scheduled for laparoscopic colorectal cancer resection exclusion criteria: * asa physical status ⅳ * severe hepatorenal disease * heart failure * infection * increased intracranial pressure, seizure * preoperative chemotherapy * immune or endocrine disease * metastasis to other organ * problem with communication * pregnancy * body mass index \> 35 kg/m2
unilateral posterolateral approach for spondylodiskitis

Conditions: Discitis

Summary: this retrospective study assess the efficacy and safety of a posterolateral unilateral approach for debridement and titanium cage insertion supplemented by contralateral transfascial screw fixation for sick patients suffering from septic thoracolumbosacral spondylodiskitis. hematogenous pyogenic spondylodiskitis requires surgical intervention in cases of development of neurological signs, spinal instability, progressive spinal deformity and abscess. when operative treatment is indicated, an anterior approach by open thoracotomy or by a thoraco-abdominal approach or combined anterior and posterior approaches are recommended. in cases of severe sick patients anterior approach is associated with high morbidity and mortality.

twenty consecutive sick (asa\>iii) patients, 14 men and 6 women, aged 64±14 years, suffering from single level septic thoracolumbosacral spondylodiskitis underwent an one-stage less invasively unilateral posterolateral decompression, insertion of titanium cage\& pedicle screw fixation plus contralateral transfascial pedicle screw fixation.

Eligibility criteria:
inclusion criteria: * single-level thoracic, thoracolumbar, lumbar or lumbosacral spondylodiskitis * medical comorbidities were present in all 20 patients. these included diabetes mellitus, chronic renal insufficiency, advanced heart insufficiency, hypertension, cortisone abuse, drug abuse and/or advanced age (\>65y). exclusion criteria: -

Keywords: spondylodiscitis titanium cage posterolateral debridement immunosuppressed less invasive spine infection
to evaluate the efficacy and safety of pegozafermin in subjects with severe hypertriglyceridemia

Conditions: Severe Hypertriglyceridemia

Summary: to determine the effect of pegozafermin on fasting serum triglyceride levels in subjects with severe hypertriglyceridemia (tg ≥500 to ≤2000 mg/dl) after 26 weeks of treatment.


Eligibility criteria:
inclusion criteria: * age ≥22 years * willing to enter a medication/lifestyle stabilization period during the screening period, which means maintaining those stable medication, eating, and exercise habits for the duration of the study * subjects should be on stable background lipid modifying therapy (lmt) to manage ascvd for a minimum of 4 weeks prior to first qualifying tg exclusion criteria: * positive for hepatitis b virus (hbv), hepatitis c virus (hcv), or human immunodeficiency virus (hiv) * uncontrolled or newly diagnosed (≤3 months since diagnosis) type 2 diabetes mellitus as determined by the principal investigator. subjects must have hba1c level ≤9.5% at screening. medications for glucose management must be stable for at least 4 weeks prior to screening * type 1 diabetes mellitus * a history of symptomatic gallstone disease, gallstone pancreatitis (unless treated with cholecystectomy), or any other ongoing symptomatic biliary disease * acute pancreatitis within 6 months prior to screening * subjects with chronic pancreatitis * known or suspected familial chylomicronemia syndrome (fcs) (type 1 hyperlipoproteinemia) other inclusion and exclusion criteria may apply.

Keywords: shtg hypertriglyceridemia metabolic diseases hyperlipidemias dyslipidemias lipid metabolism disorders
a phase ii study of ak104 plus lenvatinib and tace in hcc

Conditions: Unresectable, Non-metastatic Hepatocellular Carcinoma

Summary: to evaluate the efficacy and safety of ak104 plus lenvatinib combined with on-demand tace in participants with unresectable, non-metastatic hepatocellular carcinoma


Eligibility criteria:
inclusion criteria: * signed written informed consent form voluntarily. * histologically or cytologically documented hepatocellular carcinoma. * cnlc iia iib or iiia * the main portal vein was not completely obstructed, * child-pugh a or b * at least one measurable lesion according to recist criteria * ecog ps 0-1 * adequate organ function * estimated life expectancy of ≥3 months * for women of childbearing potential: agreement to remain abstinent; for men: agreement to remain abstinent exclusion criteria: * histologically or cytologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc * for hcc lesions ≥ 10 cm in any dimension, imaging evaluation showed that there were more than 10 lesions * the main portal vein and the left and right primary branches were clogged with cancer thrombus * history of hepatic encephalopathy or liver transplantation * any risk of bleeding; severe bleeding tendency or coagulation dysfunction, or under thrombolytic therapy. * occurred arteriovenous thromboembolic events within 6 months before the first administration. * inadequately controlled hypertension. * attack of symptomatic congestive heart failure (lvef\<50%); history of congenital long qt syndrome. * known presence or history of interstitial lung disease or required hormone treatment interstitial lung disease. * severe infections. * receipt of any anti-tumor treatment, chemotherapy, targeted therapy, immunotherapy, * enrollment of another clinical study within 4 weeks prior to the first administration of study drugs. * unable to receive an enhanced ct or mri scan of the liver.
gpr vs manual pt for chronic neck pain

Conditions: Nonspecific Chronic Neck Pain

Summary: effective treatment for nonspecific chronic neck pain is a clinical challenge. patients will be randomized into two groups to compare the outcomes of global postural re-education (gpr) with standard manual physical therapy on with respect to pain, function, kinesiophobia, range of motion, perceived effect, and satisfaction.

these study will use two groups: one to receive gpr which is a systematic method of addressing musculoskeletal pain and related functional deficits and the other to receive "usual care" manual pt which will be individualized to the patient's condition. usual care will include techniques commonly used in clinical practice selected by the physical therapist after initial examination. after nine weeks of treatment, baseline measures will be re-evaluated. after conclusion of the first phase of the study, patients who were randomized to the "usual care" group will cross-over and receive gpr.

Eligibility criteria:
inclusion criteria: -nonspecific neck pain lasting at least 3 months exclusion criteria: * acute or subacute cervical pain * specific or known cause of pain * central or peripheral neurological signs * systemic pathology * rheumatologic pathology * neuromuscular pathology * cognitive impairment * surgical intervention in the last 6 months prior to study * physical therapy treatment in the last 6 months prior to study

Keywords: neck pain chronic global postural re-education manual therapy physical therapy
neurofeedback rehabilitation with fes and vr for pd

Conditions: Parkinson Disease

Summary: recoverix pro system is a brain-computer interface (bci) device that combines motor imagination (mi), with functional electrical stimulation (fes) and virtual reality (vr) as feedback devices. the user wears an electroencephalography (eeg) cap that registers the neural activity during the mental practice. this system allows the user to control the feedback devices (fes +vr) with the mi. the goal of this clinical trial is to know the safety and clinical effectiveness of recoverix-based treatment for improving motor functions in parkinson's disease patients. researchers will compare the functional results obtained by recoverix system, to the standard treatment based in fes + vr + mi without monitoring the eeg activity. the questions to answer are: 1. will parkinson's patients who undergo recoverix therapy significantly improve their motor functions? 2. is the functional improvement achieved with the bci treatment superior to the standard mi+fes+vr treatment? 3. is the recoverix-based therapy as safe as the standard treatment? participants will have to perform a complete assessment to evaluate their functionality before and after the intervention (motor skills, walking ability, fatigue, impact of the disease in daily living activities). patients in the bci group will receive 6 sessions per week during 4 weeks of bci training with fes and vr feedback (24 sessions in total). patients in the control group receive 6 sessions of fes + vr therapy per week for 4 weeks (24 sessions in total). patients in the control group will receive the same instructions as the experimental but will not wear the eeg cap.


Eligibility criteria:
inclusion criteria: * diagnosis of pd * hy stage between 1 to 3 * age between 40 - 80 years old * ability to walk independently * stable medication usage * stable neurological condition * able to sign the informed consent. * able to follow the study protocol. exclusion criteria: * other neurological diseases * severe depression * uncontrolled diabetes * concomitant severe neurologic, cardiopulmonary, or orthopedic disorders * debilitating conditions or vision impairment that would impede full participation in the study. * unpredictable motor fluctuations * pregnant * active or passive implanted medical devices such as pacemakers which do not allow the use of fes. * implanted metallic fragments in the upper and lower extremities which can limit the use of fes. * under the influence of anesthesia or similar medication. * with fractures or lesions in the upper and lower extremities. * inadequate control of a bci system.

Keywords: brain-computer interface neurofeedback eeg feedback electrical stimulation therapy virtual reality
evaluation of complete median nerve transection with clinical, electroneuromyographic and diffusion tensor imaging

Conditions: Wound, Healed (Morphologic Abnormality); Injury of Median Nerve

Summary: the aim of this study is to determine whether clinical, sensory and motor development correlated with the values obtained from electroneuromyography and dti in postoperative follow up patients who underwent primary repair after the total median nerve injuries. median nerve is one of three major nerves of hand and forearm and often injure with glass etc, in follow up of healing; clinical examination and enmg are often used. both of these methods are subjective, noninvasive and objective new method is required. in this context; differences between intact, recovering and not healed nerve tissue's diffusions have led to the hypothesis; "the recovery of the repaired nerve tissue can be monitored by diffusion tensor imaging method".

the aim of this study is to determine whether clinical, sensory and motor development correlated with the values obtained from electroneuromyography and dti in postoperative follow up patients who underwent primary repair after the total median nerve injuries. median nerve is one of three major nerves of hand and forearm. it is below flexor tendon and retinaculum at the level of the wrist and often injured at this level and subtotally. the primary microsurgical suture technique under a microscope is the gold standard treatment. in follow up of healing; clinical examination and enmg are often used. both of these methods are subjective, although enmg is more objective, however that is an invasive method, and need experienced neurologists. so, noninvasive and objective new method is required. in this context; differences between intact, recovering and not healed nerve tissue's diffusions have led to the hypothesis; "the recovery of the repaired nerve tissue can be monitored by diffusion tensor imaging method". there is no similar study in the literature. ten patients who were operated for median nerve injuries in 2014 will be enrolled. in the sample, correlations between tinnel test, motor strength assessment (medical research council (mrc) scale), static two-point discrimination test (s2pd), semmes-weinstein (sw) monofilament test, the disability of the arm, shoulder and hand (dash) test, emg with the dti results will be assessed. at the end of the study; it is expected that a significant correlation between conventional methods and dti. if the results support the hypothesis; dti may get to the literature as noninvasive and objective method in follow of nerve regeneration.

Eligibility criteria:
inclusion criteria: * 18 - 40 years old * total and isolated median nerve transection exclusion criteria: * under 18 and over 40 years old * partially transection of median nerve * median nerve transection with radial or ulnar nerve injury
nurse amie: a tablet based supportive care platform in metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: the investigators propose to build and test a supportive care software platform called nurse amie (addressing metastatic individuals everyday) to be provided to metastatic breast cancer patients on android tablets. this program will be tested in 50 metastatic breast cancer patients within the penn state cancer institute's 28 county catchment area. the company with whom the investigator will partner to develop this application is already working with multiple investigators at the institution (webster group).

goals of the nurse amie software program are to regularly assess psychosocial, functional, and symptom needs among metastatic breast cancer patients and to provide appropriate interventions via youtube style videos, weekly skype calls (face to face, tablet to tablet) with a patient navigator at penn state, and appropriate referrals to phone or in person consultations as needed. the proposed nurse amie software program will allow for the provision of resources (youtube style videos, audio files, exercises) to intervene on many of the common symptoms and challenges experienced by metastatic patients. this is an identified need on the part of both metastatic patients and their medical care teams. finally, it will also allow patient navigators to check in with patients, reviewing responses to surveys, discerning whether new or different interventions are needed, and connecting women to palliative care and other services if additional care is warranted.

Eligibility criteria:
inclusion criteria: 1. women with metastatic breast cancer 2. ecog performance score ≤3. 3. english speaking 4. with sufficient vision/hearing or family support exclusion criteria: 1. medical or psychiatric conditions (beyond breast cancer, its treatment, and its symptoms) that would impair our ability to test study hypotheses (e. g. psychotic disorders, dementia, inability to give informed consent or follow the instruction). 2. patients who are receiving any other behavioral intervention
dlcl002 protocol for patients with high risk aggressive b-cell lymphoma

Conditions: Diffuse Large B Cell Lymphoma; High-grade B-cell Lymphoma; Transformed Lymphoma

Summary: patients eligible for the study will receive r-da-edoch as the induction therapy and be evaluated by pet ct after the fourth cycle. patients achieve cr at interim-pet(deauville score 1-3) will receive either asct or the remaining 4 cycles of r-da-edoch, while those achieve pr(deauville score 4-5) will be rescued by two courses of r(2)-dhap and then be revaluated by the second interim-pet. patients who achieved cr+good pr(deauville score 4) after the rescue therapy will be consolidated with asct,and those remain in pr(deauville score 5) will receive other rescue treatments(including asct+car t).

survival for patients with high risk aggressive b-cell lymphoma is still unsatisfied. dose-intensified immunochemotherapy might improve the outcome. but for patients who could not achieve cr after the dose-intensified induction therapy, the prognosis is poor. the dlcl002 protocol is a total therapy which including induction therapy, rescue therapy and autologous stem cell transplantation. patients eligible for the study will receive r-da-edoch as the induction therapy and be evaluated by pet ct after the fourth cycle. patients achieve cr at interim-pet(deauville score 1-3) will receive either asct or the remaining 4 cycles of r-da-edoch, while those achieve pr(deauville score 4-5) will be rescued by two courses of r(2)-dhap and then be revaluated by the second interim-pet. patients who achieved cr+good pr(deauville score 4) after the rescue therapy will be consolidated with asct,and those remain in pr(deauville score 5) will receive other rescue treatments(including asct+car t).

Eligibility criteria:
inclusion criteria: * histological confirmed aggressive b-cell lymphoma with one of the following subtypes: 1. diffuse large b-cell lymphoma, nos with at least one poor prognostic factor as follows: 1. aaipi 2\~3(≤60 years) or ipi 3\~5(\>60 years); 2. double protein expression lymphoma(ihc myc≥40% and bcl2≥50%） with ann arbor stage of iii\~iv or aaipi 2\~3 or ipi 3\~5; 3. cd5+ dlbcl. 2. high-grade b-cell lymphoma with myc and bcl2 and/or bcl6 rearrangements; 3. high-grade b-cell lymphoma, nos 4. transformed lymphoma(no prior treatment) * age 18 to 65 years * ecog-ps: 0\~2 * life-expectancy \> 3 months exclusion criteria: * patients with central nerves system involvement * hiv positivity