Kornimate/medical-research-clean huggingface dataset:
a study to evaluate guideline adoption through quality improvement project (qip) in pulmonary and critical care medicine (pccm) department

Conditions: Lung Cancer

Summary: this is a cluster randomized controlled trial with pccm department in each site being the cluster. fifty-four sites' pccm departments will be randomized to the qip arm versus control arm in 2:1 allocation ratio. the qip arm will perform qip intervention. the control arm will not receive intervention and continue with usual care. the primary endpoints of this study are molecular testing rate of non-small cell lung cancer (nsclc) prior to the first systematic anti-tumor therapy, and adjuvant or first line targeted therapy treatment rate in actionable oncogenic alterations (aga) nsclc.

approximately 1728 patients from 54 sites will be enrolled (about 30 nsclc \[20%-30% squamous cases\] and 2 extensive-stage small-cell lung cancer \[es-sclc\] patients in each site). patients in the qip arm will be enrolled after about 3-month qip intervention. patients in the control arm will be enrolled as soon as the trial starts. data on lung cancer diagnosis and treatment pattern will be collected.

Eligibility criteria:
1. cluster 1.1 cluster inclusion criteria 1.1.1 pccm department in tier 3 hospital. 1.1.2 pccm department's standardized construction certification is "qualified ". 1.1.3 pccm department who want to improve lung cancer healthcare quality and agree to participate in study. 1.2 cluster exclusion criteria 1.2.1 pccm department does not carry out anti-tumor treatment for lung cancer. 1.2.2 pccm department participant in other lung cancer quality improvement study. 2. individual patient 2.1 individual inclusion criteria 2.1.1 pathology diagnosed nsclc or es-sclc. 2.1.2 no prior systematic anti-tumor therapy, or prior adjuvant and neo-adjuvant therapies, definitive radiation/chemoradiation are permitted as long as treatment was completed at least 12 months prior to the development of recurrent disease. 2.1.3 performance score (ps) 0-2. 2.1.4 life expectancy \>12 weeks. 2.2 individual exclusion criteria 2.2.1 have a plan to transfer to other hospitals to receive anti-tumor therapy within 3 months after signing the icf. 2.2.2 participating in another interventional clinical study.
a study to evaluate safety, tolerability, pk and pd of hlx01 in patients with cd20-positive b-cell lymphomas

Conditions: B-cell Lymphomas

Summary: to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of hlx01 (a potential rituximab biosimilar) in patients with cd20-positive b-cell lymphomas.

this was a phase ia, multicenter, open-label, dose-escalation clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics characteristics of hlx01 injection in patients with cd20-positive b-cell lymphomas.

Eligibility criteria:
inclusion criteria: * 18 years ≤ aged ≤ 65 years, male or female; * having histologically confirmed diagnosis of relapsed/refractory cd20-positive b-cell lymphomas which needed consolidation therapy; * eastern cooperative oncology group (ecog) performance status≤1 and life expectancy ≥3 months; * providing signed and dated informed consents. exclusion criteria: * usage of rituximab or other anti-cd20 monoclonal antibody within 2 years before enrollment; * usage of hematopoietic cytokines within 1 week before enrollment, e.g. granulocyte colony stimulating factor (g-csf); * recent major surgery (excluding diagnostic surgery) within the past 8 weeks; * peripheral nervous system diseases or central nervous system diseases; * inadequate hematologic function met any of the following at screening: white blood cell count \<3.0×109/l, absolute neutrophil count (lobocyte and rhabdocyte) \<1.5×109/l, platelet count \<100×109/l, hemoglobin \<90 g/l, for patients with bone marrow involvement, absolute neutrophil count (lobocyte and rhabdocyte) \<1.0×109/l, platelet count \<75×109/l, hemoglobin \<80 g/l; * inadequate liver function met any of the following at screening: total bilirubin\>1.5×the upper limit of normal range (uln), alt or ast\>2.0×uln, alkaline phosphatase (alp)\>3.0×uln; * abnormal renal function (serum creatinine\>1.5×uln); * abnormal thyroid function (tsh\ upper limit of normal with clinical significance judged by investigators); * positive test result(s) for serum hiv antigen or antibody; * seropositivity of hbsag, or seropositivity of hbcab and hbv dna\>uln; seropositivity of anti hcv antibody; * history of herpes zoster and left with sequelae or latent infection; * other serious disease which may restrict subjects to participate in the trial (such as ongoing active infection, uncontrolled diabetes mellitus, severe cardiac insufficiency or angina pectoris, gastric ulcer, active autoimmune disease, etc.); * pregnancy or breast feeding female, or not willing to use effective contraceptive measures during the study; * allergic constitution, or known allergic to components of rituximab or other anti-cd20 monoclonal antibody; * history of alcoholism or drug abuse; participation in other clinical trials within 3 months before enrollment; * not suitable for enrollment at investigator's discretion.
treatment for early memory loss

Conditions: Cognition Disorders; Alzheimer Disease

Summary: the purpose of this study is to evaluate the effectiveness of donepezil (aricept) for the treatment of mild cognitive impairment (mci) in elderly adults. this study will also determine whether adding ginkgo biloba extract (gbe) enhances the effects of donepezil.

cognition involves important thinking processes such as perception, learning, and reasoning. there are currently no definitive treatments for cognitive deterioration. this study focuses on elderly individuals with mci because people at a pre-dementia stage may sustain the greatest and most lasting benefit from cognitive-enhancing agents. patients receive either donepezil or placebo for the first 6 months of the study. in the second 6 months of the study, patients are randomized to receive either donepezil plus gbe or donepezil alone. positron emission tomography (pet), which provides a color-coded image of the brain's blood flow in a particular area, is used to assess brain activity during memory tasks. a pet scan is performed at study entry, 6 months, and 1 year. a vasodilator (a drug that dilates the blood vessels) is administered during the pet imaging procedure to determine whether vascular disease affects memory function. a magnetic resonance imaging (mri) scan is also taken to view the brain.

Eligibility criteria:
inclusion criteria: * display impairment on at least 2 of 3 memory tests * meet the following criteria for mild cognitive impairment: subjective complaint of memory problems; no impairment in activities of daily living; general cognitive function in the normal age-adjusted range; abnormal memory function for age; and lacking full dsm criteria for dementia exclusion criteria: * have a history of major neurological, metabolic, psychiatric or cardiovascular disease (patients with a history of non-cns oncologic disease treated surgically and currently in remission will not be excluded) * have a cerebrovascular condition * abuse alcohol or drugs * have renal or hepatic disease, diabetes mellitus, gout, or adrenocortical insufficiency * are sensitive to carbonic anhydrase inhibitors, antibacterial sulfonamides, thiazide diuretics, or other sulfonamide-derivative diuretics * have taken donepezil or gbe products prior to enrollment * have taken medications, including herbal agents (exceptions will be made for routine health maintenance medications such as alendronate \[fosamax\] for osteoporosis, vitamin therapy \[not to exceed 200 percent rda for any particular vitamin\], thyroid replacement therapy, hormone replacement, and ophthalmic medications for glaucoma and other eye disorders)

Keywords: cognition memory
detection of brown adipose tissue by magnetic resonance imaging

Conditions: Obesity

Summary: the primary goal of this study is to assess the accuracy of conventional fat fraction proton mri for the detection of brown adipose tissue (bat) in healthy subjects using 18f-2-fluoro-2-deoxy-d-glucosefluorodeoxyglucose -pet as gold standard. in this pilot study, mri and pet imaging of bat of healthy adult volunteers will be performed on a combined pet/mri scanner under mild cold condition.

in the fight against obesity, brown adipose tissue (bat) is considered to be the newest target. the hypothesis is that this tissue is partially responsible for the imbalance between energy intake and energy expenditure that keeps lean people lean and obese people obese. the detection of this tissue in adult humans represents an unmet need. bat is difficult to detect and measurements of tissue fat fraction performed by magnetic resonance imaging have been proposed as a mean to differentiate the highly hydrated brown fat from the less hydrated white adipose tissue and from muscle. to this end, the objective of this study is to assess the accuracy of magnetic resonance fat fraction measurements for the detection of bat volume in adult humans, while using pet with 18f-2-fluoro-2-deoxy-d-glucose fluorodeoxyglucose as gold standard. for this study subjects will undergo a combined mri/pet scan. the scans will be done during stimulation of thermogenic activity by mild cold exposure.

Eligibility criteria:
inclusion criteria: * each subject must be fully informed and have signed consent. * bmi \< 34 * normal neurological and psychological development / able to give consent * willingness to participate in this study exclusion criteria: * subjects less than 18 years of age * severe claustrophobia * women who are pregnant, nursing an infant or planning to become pregnant in the next 30 days * people who have a condition that makes mri unsafe for them (for example, cardiac pacemaker, epicardial pacemaker leads, cochlear implants, metal aneurysm clip, iron filings in your eyes or metal halo devices) * have had radiation therapy or chemotherapy in the 2 months prior to pet scan * subjects are taking medications that may interfere with bat detection

Keywords: brown adipose tissue
enhancing prospective thinking in early recovery (beam)

Conditions: Alcohol Use Disorder

Summary: the goal of this clinical trial is to test the prosocial effects of personally-relevant, high-intensity episodic future-thinking (eft) cues in alcohol use disorder persons and related brain mechanisms. the main question\[s\] this trial aims to answer are: * will high-intensity eft cues will produce greater delayed reward preference than low-intensity cues? * will high-intensity eft cues effect greater treatment-seeking interest? * will high-intensity eft cues elicit greater response in regions for prospective thinking during delay discounting (vs. low-intensity) * will nucleus accumbens-precuneus resting connectivity correlate with behavioral ss? * will the novel behavioral ss decision-making task activate the nucleus accumbens? researchers will compare the experimental (high-intensity group) and control (low-intensity) groups to see if there are differences in the results for the questions outlined above.


Eligibility criteria:
inclusion criteria: * individuals who meet current heavy drinking (≥2 heavy drinking days/month or ≥7 drinks/week for biological females, and ≥14 drinks/week if biological male \[niaaa definition\] and/or audit scores ≥8) * english comprehension exclusion criteria: * unstable medical disorders * outside the age range of 18-60 * smell/taste disorders * unstable psychiatric conditions

Keywords: alcohol use disorder alcohol abuse heavy drinking alcohol
a study of bevacizumab plus 5-flurouracil (5-fu) based doublet chemotherapy as neoadjuvant therapy for participants with previously untreated unresectable liver-only metastases from colorectal cancer

Conditions: Colorectal Cancer

Summary: this open-label, single arm, multicenter study evaluated the resection rate in participants with colorectal cancer and previously untreated unresectable liver-only metastases after adding bevacizumab to 5-fu based doublet chemotherapy in the neoadjuvant setting. participants receive standard 5-fu based chemotherapy plus avastin bevacizumab 5 milligrams per kilogram (mg/kg) every 2 weeks for a maximum of 12 cycles combined pre- and postoperatively, unless they experienced progressive disease or unacceptable toxicity.


Eligibility criteria:
inclusion criteria: * adult chinese participants, 18-75 years of age * histologically confirmed adenocarcinoma in colon or rectum with primary lesion surgically removed * previously untreated unresectable liver-only metastases * liver lesions determined to be unresectable by multidisciplinary team (mdt, consisting of experienced hepatic surgeons, medical oncologist and radiologist). * no previous treatment against liver metastases, including chemotherapy, surgery, radiotherapy, transarterial chemoembolisation therapy (tace) and target therapy * adequate hematological, renal and hepatic function * eastern cooperative oncology group (ecog) performance status 0 or 1 * life expectancy greater than (\>) 3 months exclusion criteria: * the relapse has occurred within 6 months of completion of the adjuvant treatment * expected impossible to achieve complete resection (r0 resection) and/or gain 30% residual liver volume even with responsive neoadjuvant therapy * participant cannot tolerate the surgery * other malignancies in the past 5 years, except for curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix * any extrahepatic metastases and/or recurrence of the primary tumor * any residual toxicity from previous chemotherapy (except alopecia) of national cancer institute common toxicity criteria (nci ctc) v.4.0 grade 2 * hypertension crisis or encephalopathy * pregnant or lactating women * clinically significant cardiovascular disease * evidence of bleeding diathesis or coagulopathy * current or recent (within 10 days of study drug initiation) use of full dose of aspirin, clopidrogel or warfarin * history or evidence of central nervous system (cns) disease (for example, primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of stroke)
liposomal doxorubicin plus gemcitabine versus oxaliplatin plus fluorouracil/leucovorin for hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to determine that liposomal doxorubicin(ld) plus gemcitabine(gem) is superior to oxaliplatin（oxa） plus fluorouracil/leucovorin(folfox4) in prolonging progression-free survival（pfs） in patients with advanced hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: * eligible patients were age 18 to 75 years; * the patients had histologically, cytologically,or clinically diagnosed unresectable hcc;and were ineligible for local invasive treatment. clinically diagnosed patients had to have: (1) evidence of hbv or hcv with hepatic cirrhosis; (2) a-fetoprotein levels 400g/l; and (3) morphologic evidence of hypervascular liver tumor. patients had to have at least one measurable lesion according to recist (version 1.0; ≥2 cm on computed tomography \[ct\]; 1 cm on spiral ct or magnetic resonance imaging). lesions that had undergone previous interventional or local therapy were not considered measurable lesions. * ecog score≤2; * life expectancy 3 months; * barcelona clinic liver cancer (bclc) stage b or c disease; * child-pugh stage a or b disease; * adequate organ and marrow function, with neutrophil count≥1.5x10e9/l, platelet count≥75×10e9/l, ast or alt﹤2.5×upper limit of normal (uln), total bilirubin \<1.5×uln, international normalized ratio \<1.5;normal baseline left ventricular ejection fraction_lower limit of normal for the institution. patients with ast and alt\< 5 ×uln could be recruited if total bilirubin was in the normal range. * patients had to provide signed informed consent to participate. exclusion criteria: * documented allergy to platinum compounds or other study drugs; any previous oxa or dox treatment, except adjuvant treatment ﹥12 months before random assignment; * previous liver transplantation; * concomitant use of any other anticancer therapy, including interferon alfa and herbal medicine approved by the local authority to be used as anticancer medicine (except palliative radiotherapy to a nontarget lesion); * cns metastasis; * other serious illness or medical condition.
evaluation of injectable beta-tricalcium phosphate clinically in treatment of grade ii furcation involvement

Conditions: Furcation Defects

Summary: this study will be conducted to evaluate clinically and radiographically the use of pd vitalos cement® bone graft in the treatment of class ii furcation defects comparing with hydroxyapatite bone graft and biodegradable collagen membrane in the treatment of class ii furcation defects.

the study is a randomized, controlled clinical trial. patients were randomly divided into two equal groups, group i (test group): included seven grade ii furcation defects treated by beta tricalcium phosphate bone cement only. group ii (control group): included seven grade ii furcation defects treated with granulated beta tricalcium phosphate bone graft covered by resorbable collagen membrane.

Eligibility criteria:
inclusion criteria: * • presence of a lower molar with critical size grade ii furcation defect (15) with a horizontal component of 4 mm and a vertical component of 4 to 6 mm (18), detected using naber's probe and william's periodontal probe. * patient's age between 30 - 50 years. * both sexes. * the patient should be psychologically accepting the procedures. * patients should be systemically free. exclusion criteria: * • uncooperative patients regarding oral hygiene measures performance. * patients with para functional habits. * smokers. * pregnant or lactating women. * patients who underwent any periodontal surgeries in the study site during the six months prior to study.

Keywords: grade ii furcation defects
videocapillaroscopy assessment during systemic agent therapy in psoriasis

Conditions: Psoriasis

Summary: the aim of this study is to determine if videocapillaroscopy could be used as an objective and reliable method to assess psoriasis severity and to document improvement during treatment by measuring changes in vascular features.

this is a single-center, prospective, observational study that will recruit subjects from northwestern university to examine the degree of improvement of psoriatic plaques during systemic therapy treatment. thirty patients with a confirmed diagnosis of "active" psoriasis treated with a single systemic agent will be recruited from the northwestern medical faculty foundation dermatology clinic. the study population will include 15 patients receiving adalimumab and 15 patients receiving methotrexate. eight visits will be completed for each subject: visit 0 (baseline) and visits 1-8 (week 2, 4, 6, 8, 12, 16 and 24). at the baseline visit, after informed consent is obtained, a capillaroscopic examination will be performed to assess for evidence of characteristic vascular alterations. if such changes are present, the remainder of the baseline visit will be completed. this includes gathering personal information (age, race, gender etc.), clinical history (time of first diagnosis, presentation site, treatment used, biopsy results if previously performed, etc.) and past medical history (including current and previous medications). at each of the subsequent visits (visit 1-8), any changes to medical history and/or medications will be obtained and recorded. at each of the eight visits, a dermatologic physical examination, including pasi and pga scores will be performed.

Eligibility criteria:
inclusion criteria: * subjects with a clinical diagnosis of chronic active plaque psoriasis * subjects eligible for systemic monotherapy (oral or biologic agents). * subjects with evidence of characteristic vascular alterations on capillaroscopic examination. * subjects who are able to complete the study visits and procedures, including completion of the dlqi questionnaire. * subjects who are willing to have standardized digital photographs taken of 2 different target plaque lesions on the extremities. * subjects who are willing to have videocapillaroscopic photographs taken of 2 different target plaque lesions as well as of 2 areas of uninvolved skin on the extremities. * subjects who have had a "4 week" washout period if they have recently changed systemic psoriatic therapy. exclusion criteria: * those who do not fit the inclusion criteria. * subjects who are unable to understand the protocol or give informed consent.

Keywords: videocapillaroscopy, psoriasis, systemic agent
study to assess the efficacy and safety of dysport® in cervical dystonia

Conditions: Cervical Dystonia

Summary: the aim is to demonstrate equivalent efficacy and safety in the treatment of the two most frequent forms of cervical dystonia (predominantly rotational torticollis and predominantly laterocollis) with the standard initial dose of 500 units dysport®. the patients will be assigned to one of the two basic types of cervical dystonia, either predominantly rotational torticollis or predominantly laterocollis on the basis of clinical examination. this will determine which therapy is to be administered, using the clearly defined, structured injection protocols.


Eligibility criteria:
inclusion criteria: * de novo patients with cervical dystonia * outpatient * patients to be of age 18 years or older * written informed consent to participate in the study exclusion criteria: * pre-treatment of cervical dystonia with botulinum toxin * pre-treatment with botulinum toxin for any indication other than cervical dystonia within the past 12 months * pure retro- or antecollis * neurological or other diseases which may affect head and neck motor function or neuromuscular transmission, e.g. polyneuropathy with pareses, myasthenia, myopathy, motor neurone diseases, bekhterev's disease

Keywords: dysport, cervical dystonia
low-level laser therapy on oral pemphigus vulgaris patients.

Conditions: Pemphigus Vulgaris

Summary: to assess the therapeutic efficacy of low level laser therapy on oral pemphigus vulgaris patients.


Eligibility criteria:
inclusion criteria: * patients with oral pemphigus vulgaris exclusion criteria: * other causes of oral ulcers
ivm versus standard ivf in infertile patients diagnosed with pcos

Conditions: PCOS

Summary: a single center, prospective, open-label, non-inferiority randomized controlled clinical trials (1:1 treatment ratio) regarding pregnancy outcomes between ivm and standard ivf among infertility couples with pcos in china.

a single center, randomized controlled clinical trial will enroll 350 couples with pcos undergoing their first cycle of ivf. the participation in this study will be approximately 2 years with a total of 7 visits from the cycle beginning, pregnancy to delivery. on day 2 or day 3 following the onset of menstrual bleeding, eligible patients will be allocated to two groups at a ratio of 1:1- ivm protocol, and standard ivf protocol. all participants will be randomized through stratified block randomization according to the study sites.

Eligibility criteria:
inclusion criteria: 1. infertile couples scheduled for their first ivf cycle. 2. women diagonosed with polycystic ovarian syndrome. 3. voluntary participation and informed consent obtained. exclusion criteria: 1. couple with contraindication for ivf or icsi. 2. couples receiving donor sperm or donor eggs. 3. couples with indications or have plan to receive pgd and pgs. 4. sperm analysis diagnosed as azoospermia; 5. either male partner or female partner with an abnormal chromosome karyotype (chromosome polymorphisms was not included). 6. women who have undergone unilateral ovariectomy.

Keywords: in vitro maturation polycystic ovarian syndrome oocyte