Kornimate/medical-research-clean huggingface dataset:
clinical performance of the therapy option flexpoint of the pd cycler sleep•safe harmony

Conditions: Renal Failure; Chronic Kidney Disease

Summary: analysis and comparison of treatments with and without the flexpoint technology (flexible volume and dwell time management) of the pd cycler sleep•safe harmony

the primary objective of this study are: * to investigate and compare the clinical performance of standard (default) flexpoint settings to minimum flexpoint settings and to the maximum value for permitted peritoneal residual volume of flexpoint settings of the pd cycler sleep•safe harmony in the treatment of pd patients. * to assess whether usage of the settings of the therapy option flexpoint (flexible volume and dwell time management) of the pd cycler sleep•safe harmony that deviate from the system default and from former sleep•safe settings, influences the efficacy of apd treatments as well as the hydration status (by using bcm) of pd patients. the secondary objectives of this study are: * patients´ quality of life (qol) * number of alarms * to investigate the effects on solute removal * to investigate the tolerability of the flexpoint therapy options * adverse events / sae

Eligibility criteria:
inclusion criteria: * informed consent signed and dated by study patient and investigator/ authorised physician * minimum age of 18 years * ckd patients with indication for renal replacement therapy * patients being treated with apd for at least 3 months * patients using the sleep•safe harmony pd cycler (version 3.1) * fluid status regularly monitored with body composition monitor (bcm) * proper functioning catheter * intraperitoneal pressure (ipp) ≤ 18 cm h2o * ability to understand the nature and requirements of the study exclusion criteria: * any conditions which could interference with the patient's ability to comply with the study * previous participation in the same study * patients who have any condition prohibiting the use of bcm, like patients with major amputations (e.g. lower leg) * patients receiving polyglucose containing pd solution * respiratory or abdominal wall disease deemed to contraindicate intraperitoneal fill volume (fv) manipulation * patients who suffer from peritonitis/exit site infection during the last 4 weeks * women of childbearing age without effective means of contraception, pregnancy (pregnancy test will be conducted at start and end of study) or lactation period * life expectancy \<3 months * participation in an interventional clinical study during the preceding 90 days

Keywords: renal replacement therapy peritoneal dialysis automated peritoneal dialysis pd cycler
maintenance gemcitabine in the chinese advanced lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: lung cancer, the most common cancer worldwide, remains the leading cause of cancer death. approximately two-thirds of all patients with newly diagnosed non-small-cell lung cancer (nsclc) present with advanced stage that palliative chemotherapy is the only appropriate measure. the standard treatment for this patient population consists of third generation platinum-based doublet regimen for no more than 6 cycles followed by watch and wait until disease progression (pd) before the administration of second-line and third-line systemic anticancer therapeutic agents. patients who go on to receive second-line therapy represent a selected subgroup with an improved overall prognosis. switch maintenance therapy with pemetrexed or erlotinib in patients with advanced nsclc without pd after first-line chemotherapy has been confirmed to improve progression free survival (pfs) and overall survival (os) significantly compared with placebo in two large randomized controlled studies. however, continuation gemcitabine maintenance therapy in this setting yields conflicting results in the west, i.e.showing a prolongation of pfs without os improvement. thus, we investigate the efficacy and safety of continuation of gemcitabine maintenance therapy for patients with metastatic nsclc with ecog performance status of 0-1 and without pd after four cycles of first-line chemotherapy with gemcitabine and cisplatin in china.


Eligibility criteria:
inclusion criteria: * histologic or cytologic confirmed diagnosis of stage iv nsclc according to 2009 the seventh edition of tnm staging of lung tumors. * no disease progression after four cycles of first-line chemotherapy with gemcitabine plus cisplatin (running period) within one month before the enrollment. * brain metastases are permitted if treated with full course of whole brain radiotherapy without the presence of symptomatic central nervous system metastases. * ecog score 0-1 exclusion criteria: * first-line chemotherapy other than combination treatment of gemcitabine plus cisplatin * other therapy including targeted therapy, immunotherapy and prior radiotherapy for the treatment of the primary tumor prior to enrollment. * active infection * inadequate liver and renal function. * serious concomitant systemic disorder incompatible with the study. * second primary malignancy (except in situ carcinoma of the cervix, adequately treated basal cell carcinoma of the skin, t1 vocal cord cancer in remission, or prior malignancy treated more than 5 years prior enrollment without recurrence) * presence of the pregnancy

Keywords: advanced nsclc maintenance therapy gemcitabine
plasmodium falciparum artemisinin resistance vietnam

Conditions: Plasmodium Falciparum

Summary: resistance of plasmodium falciparum toward artemisinins, the most important drug for the successful treatment of malaria, has been confirmed in cambodia. there are few reports from neighbouring countries about delayed parasite rates. the investigators therefore aim to assess parasite clearance in malaria patients in central vietnam when treated according to national standard guidelines.

general objective to evaluate the efficacy of dha-ppq in patients with uncomplicated falciparum malaria in a rural area of central vietnam, and to assess the in vitro susceptibility of p.falciparum isolates to dha and ppq. specific objectives 1. to measure the parasite clearance time in falciparum malaria patients treated with dha-ppq. 2. to determine the efficacy of dha-ppq at day 42 post-treatment. 3. to assess the in vitro susceptibility of p.falciparum isolates towards dha and ppq in quang nam province. 4. to compare genetic profiles of p.falciparum isolates with delayed and those with normal clearance times in order to identify potential markers of resistance;

Eligibility criteria:
inclusion criteria: * age: from 6 months of age; * fever (body temperature above 37.5c) or history of fever in the previous 24 hours; * mono-infection with p.falciparum with parasite density between 500-100,000/µl * written informed consent to participate to the trial. for patients aged less than 18 years, an informed consent will be obtained from a parent or a guardian. exclusion criteria: * mixed malaria infection; * pregnancy or lactation (urine test for β human chorionic gonadotropin to be performed on any woman of child bearing age unless menstruating); * concomitant acute illness necessitating specific treatment (antibiotics); * underlying chronic severe illness (e.g. cardiac, renal, hepatic diseases, hiv/aids). * severe malnutrition; * danger signs: * not able to drink * incontrollable vomiting * recent history of convulsions (\>1 in 24 hours) * unconscious state; neurological impairment * unable to sit or stand * signs of severe malaria: 1. cerebral malaria (unrousable coma) 2. severe anaemia (htc\< 15%) 3. renal failure (serum creatinine \> 3 mg/dl) 4. pulmonary oedema; 5. hypoglycemia (\<40mg/dl) 6. shock (systolic bp \< 70 mmhg in adults, 50 in children) 7. spontaneous bleeding 8. repeat generalized convulsions 9. macroscopic haemoglobinuria 10. severe jaundice * persons who have received quinine, artemisinin or artemisinin derivatives within the last 7 days, 4-aminoquinolines within the last 14 days, pyrimethamine and/or sulfonamides within the last 28 days, or mefloquine within the last 56 days should be excluded from the in vitro testing

Keywords: p.f resistance
double blind, placebo-controlled study of raloxifene for negative symptoms of schizophrenia in postmenopausal women

Conditions: Schizophrenia

Summary: primary objective: to assess the efficacy of adding raloxifene as an adjunct to antipsychotic treatment to improve negative symptoms of schizophrenia in postmenopausal women. this is a double-blind, randomized, placebo-controlled study of raloxifene as adjuvant treatment to antipsychotic treatment. treatment period of 12 weeks. the primary result obtained is that women treated with 60 mg of raloxifene compared to those treated with a placebo show greater improvement in psychotic symptoms. the investigators also found improved response in some aspects of social functioning and neuropsychological functioning.


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia (dsm-iv criteria) * postmenopausal patients. postmenopause is defined as after a period of one year of spontaneous amenorrhea and a serum follicle stimulating hormone (fsh) level \> 20iu/l. * stable doses of their current antipsychotic medication for at least a month prior to study initiation. * presence of significant negative symptoms (defined as one or more negative symptom score greater than 4 in the panss scale) (kay 1987) * patients have to give written informed consent to participate in the study. exclusion criteria: * patients with a substance abuse/dependence diagnosis in the previous six months. * mental retardation. * endocrine abnormalities, acute or chronic liver disease, impaired kidney function. * history of thromboembolism, breast cancer, abnormal uterine bleeding, history of cerebrovascular accident. * patients taking hormone replacement therapy. * patients taking mood stabilizer medication that cannot be discontinued.
lobectomy-first vs. lymphadenectomy-first for operable nsclc (lofty)

Conditions: Non Small Cell Lung Cancer

Summary: during the surgery for non-small cell lung cancer (nsclc), lymphadenectomy or lobectomy are performed first, different surgeons have different choices. oncology textbooks require dissecting distant lymph nodes (lns) first and then dissecting nearby lns. according to this requirement, thoracic surgeons should first perform lymphadenectomy and then lobectomy. unfortunately, there is no high-level evidence to prove which surgical sequence is more beneficial to the long-term survival of nsclc patients. in this multi-center randomized controlled trial (rct), patients with stage i-ii nsclc were enrolled as the research object to determine which surgical sequence (lymphadenectomy-first vs. lobectomy-first) is better for the short-term and long-term outcomes in nsclc patients.


Eligibility criteria:
inclusion criteria: 1. age from 18 to 80 years old; 2. the first clinical diagnosis before surgery was non-small cell lung cancer, including adenocarcinoma, squamous cell carcinoma, large cell carcinoma, and other unknown types; 3. clinical stage t1-2n0-1 (ci-ii): maximum diameter of tumor \<= 5 cm and short diameter of mediastinal lymph node \<= 1cm in thin layer computed tomography (ct); 4. the patient's physical condition is able to tolerate lobectomy: (1) goldman index 0-1; (2) predicted forced expiratory volume in 1s (fev1) \>= 40% and diffusing capacity of the lung for carbon monoxide (dlco) \>= 40%; (3) total bilirubin \ = 60 ml/min; 5. performance status of eastern cooperative oncology group (ecog) = 0-1; 6. all relevant examinations were completed within 28 days before the operation; 7. patients who understand this study and have signed an approved informed consent. exclusion criteria: 1. patients who have undergone anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, immunotherapy) before surgery; 2. patients with previous medical history of other malignant tumors or combined with second primary cancer at the time of enrollment; 3. patients who meet all of the following criteria are eligible for sublobar resection (segment/wedge resection): (1) ground glass opacity (ggo) with a solid component \<= 50%; (2) the largest diameter of nodule is \<= 2 cm; (3) the nodule is located in the outer third of the lung field; 4. patients with preoperative diagnosis of pure ggo; 5. patients with previous medical history of unilateral thoracotomy; 6. women who are pregnant or breastfeeding; 7. patients with active bacterial or fungal infection that is difficult to control; 8. patients with serious psychosis; 9. patients with a history of severe heart disease, heart failure, myocardial infarction or angina pectoris in the past 6 months.

Keywords: non-small cell lung cancer lobectomy lymphadenectomy
use of socially assistive robots for long term care older adults with cognitive impairment and apathy

Conditions: Alzheimer Disease

Summary: the objective of this study is to demonstrate the impact of a socially assistive robot system on reducing apathy among cognitively impaired older adults residing in long term care facilities. earlier phases of this project demonstrated the feasibility and acceptability of the robotic system. first, investigators will improve the social robotic interaction architecture through additional software development, enhance its versatility, and make it easy for non-experts to run. second, 188 participants will be randomized to either usual activity programs at the long term care facility, or the usual activity programs plus the robotic activities. researchers will examine the effect on apathy and also plan on examining underlying individual and facility factors that influence the impact of the robotic activities.


Eligibility criteria:
inclusion criteria: * residing \>3 months in long term care facility * evidence of mild cognitive impairment (sage score 15-16), mild dementia (sage score \ 1, dsrd 19-36) * symptoms of apathy (score 30+ on aes-c) exclusion criteria: * severe cognitive impairment * physically unable to participate * unable to provide assent * uncorrected vision or hearing * never spoke english * unable to sit comfortably in chair * acutely ill, terminally ill or unresponsive * unable to be moved to activity location * aggressive or combative

Keywords: apathy robotics virtual reality
dynamic splinting for excessive pronation following cva

Conditions: Pronation Contracture

Summary: the purpose of this study is to examine range of motion and lasting effects of botox injections along with the use of the supination dynasplint.


Eligibility criteria:
inclusion criteria patients enrolled will have been diagnosed with excessive pronation following a stroke and will display the following symptoms: * pronation contracture * ability to provide consent and follow directions as related to the protocol exclusion criteria * treatment with benzodiazepines * treatment with baclofen (pump or oral) * treatment with dantrolene sodium * treatment with tizanidine

Keywords: excessive pronation cva forearm excessive pronation following cva
assess the risk of solid organ transplant rejection following vaccination with pandemrix™ in uk

Conditions: Influenza

Summary: this study aims to assess the risk of solid organ transplant (sot) rejection following vaccination with pandemrix™ and/ or seasonal influenza vaccination.

data on the safety of pandemic h1n1 vaccination in transplanted patients is relatively limited; to date, although some studies showed transient increases in alloreactivity, there is no evidence that h1n1 vaccines caused clinical rejection or organ dysfunction. in addition, studies have shown that influenza infection is a known independent risk factors for rejection. considering that transplant recipients are a target population for immunisation with future pandemic vaccines, it is important to investigate the risk of rejection following vaccination in this patient population. using the self-controlled case series design that allows to control implicitly for potential confounding factors, this study aims at investigating the risk of solid organ transplant rejection (liver, kidney, lung, heart, pancreas) following vaccination with pandemrix™ in the united kingdom clinical practice research datalink gp online database (cprd gold). data from the hospital episodes statistics database will also be used. the effect of seasonal influenza vaccination and of various infections including influenza h1n1 will also be explored.

Eligibility criteria:
inclusion criteria: * subject defined as acceptable in the cprd gold. * subject with at least one solid organ transplant rejection reported in the cprd gold and/or hes during the overall study periods (01 september 2006 to 31 october 2010). exclusion criteria: • subject from hes matched to more than one subject in the cprd gold.

Keywords: solid organ transplant rejection united kingdom influenza h1n1 pandemrix™
cohort study of new prognostic factors with peripheral blood and bone marrow evaluation at the time of diagnosis and relapse in myelodysplastic syndrome

Conditions: Myelodysplastic Syndrome

Summary: developing a molecular genetic test that can identify prognostic factors which can predict response to treatment, and to contribute to the establishment of future therapeutic strategies base on prognostic factors by undergoing peripheral blood and bone marrow examination of myelodysplastic syndrome (mds) patients at diagnosis and relapse.


Eligibility criteria:
inclusion criteria: * mds diagnosed by bone marrow aspiration and biopsy at severance hospital. * male and female over 16 years of age. ③ written consent of the patient to participate in the cohort ④ deaths during the study period are waiver of consent exclusion criteria: ① refusal or trouble understanding the written consent
virological and immunological monitoring in patients (suspected of/confirmed with) covid-19

Conditions: COVID-19

Summary: this study is a prospective, observational multicentric study. the study population entails adult patients hospitalized with a high clinical suspicion of covid-19 and consists of two study arms (sars-cov2- vs. sars-cov2+).this combined fundamental research project has a dual goal: on the one hand assessing immunological predisposing factors for severe infection and investigating the immunological impact of sars-cov2 infection, on the other hand studying viral characteristics. furthermore, a substudy will examine the pharmacokinetics and pharmacodynamics of hydroxychloroquine in patients receiving this antiviral treatment (revive susbstudy). to answer these research questions, samples will be collected from patients with a high clinical suspicion of covid-19, hospitalized at uz gent and 2 participating hospitals in ghent (az maria middelares en az jan palfijn).


Eligibility criteria:
inclusion criteria: * upper or lower respiratory symptoms and temperature ≥37.5°c, with high clinical suspicion of covid-19 * requiring hospitalization exclusion criteria: * known pregnancy at the time of screening * inability to give informed consent or absence of legal representative who can give informed consent.
safety and efficacy study of aztreonam for inhalation solution (azli) in cystic fibrosis (cf) patients with pseudomonas aeruginosa (pa)

Conditions: Cystic Fibrosis

Summary: the purpose of this study was to evaluate the safety and efficacy of multiple courses of azli in patients with cystic fibrosis (cf) and lung infection due to pseudomonas aeruginosa (pa).

people with cf often have lung infections that occur repeatedly or worsen over time. the lung infections are often caused by pa. treatment with antibiotics is used to reduce the presence of the bacteria. the antibiotics may be given orally, intravenously, or inhaled as a mist. the purpose of this study was to evaluate whether azli, an investigational formulation of the antibiotic aztreonam, is safe in repeated courses in patients with cf and pa. a course of azli treatment in this study comprised 28 days, followed by a 28-day period off treatment. participants could receive up to 9 courses of azli, with a total time on study of up to 18 months. safety and efficacy results for the 18-month, 9-course period are reported, with efficacy results presented on a by-treatment course basis.

Eligibility criteria:
inclusion criteria: * compliance with studies cp-ai-005 (nct00104520) or cp-ai-007 (nct00112359) by taking at least 50% of expected study medication. * completion of cp-ai-005 or cp-ai-007 or was withdrawn due to need for antipseudomonal antibiotics or for an ae unrelated to study medication tolerance. * ability to provide written informed consent/assent prior to initiation of study-related procedures. * ability to perform reproducible pulmonary function tests. exclusion criteria: * use of any investigational medication or device between the last visit of cp-ai-005 or cp-ai-007 and visit 1 of this study. * concurrent participation in a study of another investigational drug or device. * current use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone/day or 20 mg prednisone every other day. * history of sputum or throat swab culture yielding burkholderia cepacia in the previous 2 years. * history of daily continuous oxygen supplementation or requirement for more than 2 liters/minute at night. * inability to tolerate study medication in cp-ai-005 or cp-ai-007. * known local or systemic hypersensitivity to aztreonam. * inability to tolerate inhalation of a short acting beta-2 agonist. * abnormal renal or hepatic function based on results of most recent test. * female of child-bearing potential who was pregnant, lactating, or not (in the opinion of the investigator) practicing an acceptable method of birth control. * any serious or active medical or psychiatric illness which, in the opinion of the investigator, would have interfered with participant treatment, assessment, or compliance with the protocol.

Keywords: cystic fibrosis pseudomonas aeruginosa
interflex plate versus conventional miniplates in the management of anterior mandibular fractures.

Conditions: Anterior Mandibular Fracture

Summary: the study aims to compare interflex plate with conventional miniplates in management of symphyseal mandibular fracture clinically regarding pain, wound healing and postoperative occlusion, and radiographically regrading bone density.

a total of 18 patients with recent symphyseal mandibular fractures were allocated into two groups. group a, comprising 9 patients, underwent treatment with the interflex plate, while group b, also consisting of 9 patients, was treated with conventional two miniplates. clinical evaluations were carried at multiple intervals up to 12 weeks postoperatively, with radiographic assessments performed immediately after surgery and at 12 weeks to measure mean bone density at the fracture line.

Eligibility criteria:
inclusion criteria: * patients with recent anterior mandibular fracture located between the mental foramina. * adults without gender predilection who agreed to follow-up, * fractures requiring open reduction and internal fixation, and * those medically fit for general anesthesia were included exclusion criteria: * medically compromised patients, * fractures with infection, * pathological or old fractures, * completely edentulous patients, * comminuted fractures

Keywords: anterior mandibular fracture symphyseal fracture para-symphyseal fracture interflex plate functionally stabilized fixation miniplate