Kornimate/medical-research-clean huggingface dataset:
dance well therapy: a study for evaluating efficacy, safety, and feasibility

Conditions: Parkinson Disease

Summary: a new and in-teresting complementary approach for rehabilitation of parkinsonian patients is represented by "dance well", which is an artistic, multisensory dance intervention based on art and music. this study aims to evaluate the efficacy, feasibility, and safety of a 4-week dance well (dw) program in pd patients in early-medium disease stages.

background/objectives: parkinson's disease (pd) is a complex neurodegenerative disorder re-sponsible for both motor and non-motor disturbances impairing the motor behaviour. this com-plexity needs for integrated, multidisciplinary and comprehensive models of care. a new and in-teresting complementary approach is represented by "dance well," i.e., an artistic, multisensory dance intervention based on art and music. this pilot study aims to evaluate the efficacy, feasibility, and safety of a 4-week dance well (dw) program in pd patients in early-medium disease stages. methods: twenty-four pd patients (h\&y ≤ 3; moca score ≥ 13.8) were enrolled and randomly allocated into two groups, both with a twice per week frequency and lasting 4 weeks: one group underwent the dw program, while the other underwent conventional physiotherapy (cpt). de-mographic, biometric, and clinical data were collected. to study the treatment effect, motor (unified pd rating scale-iii, timed-up and go test, berg balance scale, 6-minute walk test, and falls efficacy scale), cognitive (corsi supra span test, trial making test a and b-a), and affective (beck depression inventory, state-trait anxiety inventory, apathy evaluation scale) outcome measures were as-sessed, before and after rehabilitation program. to study the treatment compliance and safety, number of dropouts and any adverse events (such as injuries and falls) were recorded.

Eligibility criteria:
inclusion criteria: * diagnosis of pd according to the uk parkinson's disease society brain bank clinical diagnostic criteria; rate score 0-3 on the modified hoehn \& yahr (h\&y) scale. exclusion criteria: * other neurological or psychiatric diseases other than pd; * serious visual and/or auditory deficits; * orthopedic-muscular and or co-morbid medical conditions precluding partici-pation in dance; * cognitive decline (moca score \< 13,8)

Keywords: pd dance well rehabilitation therapy
a study of ak109 combined with ak104 in patients with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: this is a multi-center, open label, phase ib/ii clinical study of ak109 and ak104 to evaluate the safety, tolerability, effectiveness, pharmacokinetic characteristics in advanced solid tumors .


Eligibility criteria:
inclusion criteria: 1. written and signed informed consent. 2. age ≥ 18 years and ≤ 75 years. 3. ecog performance status of 0 or 1. 4. estimated life expectancy of ≥3 months. 5. histologically or cytologically documented, locally advanced or metastatic solid tumours (nsclc, mcrc, hcc, gej, etc. ), for which standard therapy does not exist or has proven ineffective or intolerable. 6. at least one radiographically measurable lesion per recist 1.1. 7. tumor biopsy (during advanced stage) available. 8. adequate organ function. 9. female participants of childbearing potential and male partners with female partners of childbearing potential must agree to use effective barrier methods of contraception during the study and for 120 days after last dose of study drug. exclusion criteria: 1. other documented active malignancies other than for this trial within 3 years. 2. participation in other clincial trials simultaneously. 3. use of systemic anti-tumor treatments with 4 weeks, non-specific immunomodulating agents within 2 weeks. 4. prior exposure to other t cell coregulatory proteins except for pd-1/pd-l1 inhibitors (apart from cohort b, i.e. treatment naive hcc patients). 5. current use corticosteroids/immunosuppressive agents, permanently discontinuation of study drug, or having any unresolved iraes (≥grade 2) from prior pd-1/pd-l1 inhibitors treatment. 6. central nervous system (cns) metastasis, meningeal metastasis, spinal cord compression, or leptomeningeal disease. 7. uncontrolled pleural/pericardial or peritoneal effusion. 8. history of hemorrhagic event need blood transfusion, invasive approaches to intervene, or hospitalization within 3 months, or having high risks of bleeding. 9. any thromboembolic event, non-gastrointestinal fistula or female genital tract fistula within 6 months. 10. uncontrolled gastrointestinal diseases. 11. use of nsaids and anticoagulant agents within 7 days. 12. major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks. 13. severe or uncontrolled hypertension and cardiovascular/cerebrovascular diseases. 14. uncontrolled comorbidities need corticosteroids using. 15. active or prior autoimmune disease or history of immunodeficiency. 16. history of interstitial lung disease. 17. known history of active tuberculosis (tb). 18. evidence of active infections including hepatitis b and c. 19. use of anti-infectious agents within 2 weeks. 20. history of human immunodeficiency virus (hiv) infections. 21. active syphilis infections. 22. any unresolved toxicities (≥grade 2) from previous anti-cancer therapies. 23. mental illness, drug abuse, or alcohol dependence that may affect compliance with the test requirements.
the efficacy of speech competition training on auditory hallucination in schizophrenia

Conditions: Auditory Hallucination

Summary: one hundred schizophrenia patients with auditory hallucinations will be recruited and randomized into group a and group b. participants of group a will firstly receive a speech competition training for 2 weeks, and those in group b will firstly receive music intervention as placebo treatment. specifically, speech competition training include voice competition training twice a day in adjunction with drug treatment, and the patients will be required to perform voice-related tasks according to the instruction. the reaction time, accuracy rate and the number of auditory hallucinations during the task will be recorded. on the other hand, the placebo treatment includes soothing music twice a day for a fixed period of time while patients receiving drug treatment. after 2 weeks, the interventions for group a and group b will be switch. clinical symptoms will be evaluated using the auditory hallucinations rating scale, positive and negative syndrome scale, belief about voices questionnaire-revised at baseline, 2-week follow up and 4-week follow up. all the data will be analyzed with the statistical product and service solutions(spss) software.


Eligibility criteria:
inclusion criteria: * fulfilling the diagnostic criteria for schizophrenia as in the international classification of diseases (icd) - 10; * aged 18-55 years old; * education level over 6 years; * the score of p3 item in panss ≥ 3 points; * taking antipsychotics at a therapeutic dose for at least 1 month, and the symptoms of auditory hallucinations have not been significantly improved, and the score of auditory hallucinations rating scale (ahrs) is still greater than 18 points; * capable of understanding and singing a written informed consent form, and be able to cooperate in completing intervention training and assessments. exclusion criteria: * diagnosing other axis i mental disorders; * a history of severe neurological disease, brain trauma, major physical disease or history of drug dependence; * auditory hallucinations caused by organic brain diseases; * patients who cannot cooperate with the completion of training; * patients with serious suicidal or self injurious behavior; * pregnant and lactating women; * history of alcohol abuse; * intellectual impairment (iq\<70); * patients with hearing impairment.

Keywords: schizophrenia intervention
a study of cell therapy for subjects with acute kidney injury who are receiving continuous renal replacement therapy

Conditions: Acute Kidney Injury

Summary: the purpose of this study is to assess the safety and tolerability of the investigational product, sbi-101, in subjects with acute kidney injury (aki) who require continuous renal replacement therapy. sbi-101 is a biologic/device combination product designed to regulate inflammation and promote repair of injured tissue using allogeneic human mesenchymal stromal cells. the study will be conducted in two cohorts, with an interim analysis performed in between the cohorts. in the first cohort, subjects will be randomized to receive one of two treatments - low dose sbi-101 or sham control. in the second cohort, subjects will be randomized to receive one of two treatments - high dose sbi-101 or sham control. sbi-101 or sham control will be integrated into the renal replacement circuit and subjects in both cohorts will be treated for up to 24 hours.


Eligibility criteria:
inclusion criteria: * aki, as determined by the investigator based on his/her clinical judgment * able to tolerate indwelling intravascular access * has tolerated continuous renal replacement therapy for at least 12 hours prior to ip treatment * likely to require continuous renal replacement therapy for at least an additional 48 hours * ability to give informed consent exclusion criteria: * female subjects who are pregnant, planning to become pregnant, or lactating * known end-stage liver disease * hepatorenal syndrome * acute glomerulonephritis (e.g. rapidly progressive glomerulonephritis; membranoproliferative glomerulonephritis; post-streptococcal glomerulonephritis); acute interstitial nephritis (e.g. toxin- or drug- induced interstitial nephritis) or hereditary renal disease (e.g. alport's syndrome; polycystic kidney disease) * aki due to post-renal outflow obstruction * acute or chronic vasculitis of any etiology * at the time of randomization, clinical evidence (e.g. febrile) suggestive of an uncontrolled or inadequately treated systemic infection * history of a chronic systemic infection of any etiology regardless of therapy * active malignancy(-ies) and/or receiving active treatment for a malignancy(-ies), with the exception of non-melanoma skin cancer * subjects, who in the opinion of the investigator, are likely to require escalating doses of vasopressors to attain and/or maintain hemodynamic stability * systemic immunosuppressive therapy that has not been stabilized for greater than 4 months, or in the case of chronic corticosteroid therapy, a dose of \>15 mg/day of prednisone or the equivalent within the past 30 days * organ failure affecting more than 2 non-renal organs * platelet count \<25,000/ul or other serious hematological abnormalities that would place subject in imminent danger of death * any prior medical condition that, in the judgment of the investigator, would prevent the subject from safely participating in and/or completing all study requirements

Keywords: mesenchymal stromal cells msc stem cells mesenchymal stem cells
a study of tirzepatide (ly3298176) versus insulin lispro (u100) in participants with type 2 diabetes inadequately controlled on insulin glargine (u100) with or without metformin

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to compare the safety and efficacy of the study drug tirzepatide to insulin lispro (u100) three times a day in participants with type 2 diabetes that are already on insulin glargine (u100), with or without metformin.


Eligibility criteria:
inclusion criteria: * have been diagnosed with type 2 diabetes mellitus (t2dm) * have hba1c between ≥7.5% and ≤11% * have been treated for at least 90 days prior to day of screening with once or twice daily basal insulin with or without stable dose of metformin ≥1500 mg/day and up to maximum approved dose per country specific approved label, sulfonylureas or dipeptidyl peptidase 4 inhibitors * be of stable weight (± 5%) for at least 90 days * have a bmi ≥23 kilograms per meter squared (kg/m²) and ≤45 kg/m² at screening exclusion criteria * have type 1 diabetes mellitus * have had chronic or acute pancreatitis any time prior to study entry * have proliferative diabetic retinopathy or diabetic macular edema or nonproliferative diabetic retinopathy requiring immediate or urgent treatment * have disorders associated with slowed emptying of the stomach, have had any stomach surgeries for the purpose of weight loss, or are chronically taking drugs that directly affect gastrointestinal motility * have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months * have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2 * have been taking weight loss drugs, including over-the-counter medications during the last 3 months * have an estimated glomerular filtration rate \<30 ml/minute/1.73 m² \[for participants on metformin, estimated glomerular filtration rate \<45 ml/min/1.73 m2 (or lower than the country-specific threshold for using the protocol-required dose of metformin per local label)\]

Keywords: glucose-dependent insulinotropic polypeptide (gip) glucagon-like peptide-1 (glp-1) gip/glp-1 dual receptor agonist t2dm
guided bone regeneration using bovine-derived xenograft in combination with or without injectable platelet-rich fibrin

Conditions: Bone Resorption

Summary: the aim of the study was to compare the change in augmentation thickness after guided bone regeneration (gbr) using bovine-derived xenograft in combination with or without injectable platelet-rich fibrin (i-prf). this randomized-controlled clinical trial was conducted on patients with horizontal bone deficiency in the posterior regions of mandible. after implant placement, gbr procedures were randomly performed using i-prf enriched bovine-derived xenograft (test group) or bovine derived xenograft alone (control group). cone-beam computed tomography was taken at the implant sites immediately, and 6 months after surgery for assess the change in augmentation thickness as the primary outcome of the study. the secondary outcomes included marginal bone level and implant survival rate.

the study was conducted on patients who had partially edentulism with horizontal deficiency of the alveolar bone in the posterior regions of mandible. all patients were informed about treatment protocol of the study and also, the risks and benefits associated with participation. each patient provided written informed consent prior to enrollment. randomization was performed after the dental implant surgeries and the patients were randomly assigned to one of the study groups: test group included 22 patients treated with gbr using i-prf-enriched bovine-derived xenograft + resorbable membrane control group included 22 patients treated with gbr using bovine-derived xenograft + resorbable membrane all patients underwent two-stage surgical protocol that performed by the same experienced surgeon. following implant placement, i-prf-enriched bovine-derived xenograft for the test group and bovine-derived xenograft alone for the control group was carefully positioned with light compression around the implants. finally, the resorbable membrane was placed to cover the augmented area. as the second stage of surgery, healing caps were placed and the implant-supported fixed prosthesis were completed in approximately one to two months.

Eligibility criteria:
inclusion criteria: * horizontal deficiency of the alveolar bone in the posterior regions of mandible * absence of periodontal disease or previously treated * with blood tests showing platelet counts at least 150.000 mm3 * ability to understand and accept the requirements of the study. exclusion criteria: * any disorders or infection at the implantation site or adjacent tissue * tooth loss or extraction in the planned implant site within 6 months * poor oral hygiene * medical conditions that compromised tissue healing (uncontrolled diabetes, etc.) * treatments with an interfering medications (bisphosphonates, steroids etc.) * smoking habit * pregnancy or nursing

Keywords: guided bone regeneration bovine-derived xenograft injectable platelet-rich fibrin
effect of ras blockers on ckd progression in elderly patients with non proteinuric nephropathies (proercan01)

Conditions: Renal Insufficiency, Chronic; Proteinuria

Summary: this study evaluates the effect of renin-angiotensin blockers on chronic kidney disease progression in elderly (\>65 years old) patients with non-proteinuric nephropathies. half of the patients will receive angiotensin converting enzyme inhibitors, while the other half will not receive them. renal function, proteinuria and cardiovascular events will be follow up during a three year period.

study design: open, multicentre, prospective, parallel-group, randomized controlled study comparing the effect of an angiotensin converting enzyme inhibitor (acei) vs standard antihypertensive treatment without acei, in the progression of renal disease in elderly patients with non-proteinuric 3-4 stage chronic renal disease. elderly patients (\> 65 years) with moderate-severe non-proteinuric chronic renal disease (estimated glomerular filtrate rate between 19-59 ml per minute per 1.73 m2 using the chronic kidney disease epidemiology collaboration group equation) and urine-creatinine rate \< 30 mg/g, will be included. they will be randomly assigned in a 1:1 ratio to receive acei or standard antihypertensive treatment. patients will be followed up for 3 years.

Eligibility criteria:
inclusion criteria: * age \>65 years * chronic kidney disease stage 3 or 4 (gfr measured by ckd-epi 15-59 ml/min/1,73 m2) * albumine/creatinine index \< 30 mg/g in simple urine sample or albuminuria \< 30 mg/day in 24-hour urine sample. * previous hypertensive treatment:: 1. patients who have not received ras blockers in the three months prior to inclusion can be included 2. patients who are receiving ras blockers could be included after one month washout period exclusion criteria: * diabetes mellitus (type 1 or 2) * glomerulopathy * chronic heart failure or coronary heart disease * poorly controlled hypertension (\>160/100 mmhg) * monorrenal * active malignant neoplasia (except skin cancer different from melanoma). patients who have been free of malignancy for the last 5 years could be included. * chronic symptomatic or not controlled inflammatory disease (eg rheumatoid arthritis, chron disease, ulcerative colitis or systemic lupus erythematosus) * chronic liver disease * allergy or intolerance to renin angiotensin system blockers or calcium channel blockers * hepatitis b, c or hiv infection * immunosuppressive treatment in the 3 months prior to inclusion * hospitalization of any cause in the three months prior to inclusion * rapidly progressive kidney disease (decline in gfr \>5ml/min/1.73 m2/year) * inability to sign the informed consent

Keywords: renal insufficiency, chronic
arachidonic acid metabolism in carotid stenosis plaque in diabetic patients

Conditions: Carotid Stenosis

Summary: diabetes is associated with an increased risk of cardiovascular complications, as a reflection of the chronic inflammatory status. monocytes-macrophages in diabetic subjects present impaired arachidonic acid metabolism. moreover, atheromatous plaques in diabetic subjects seem to be significantly enriched in 2-aa-lpc (2-arachidonoyl-lysophosphatidylcholine) and are more inflammatory and more likely to rupture than are plaques in non-diabetic subjects. we therefore hypothesize that this vulnerability of atheromatous plaques in diabetic subjects could be explained by impaired 2-aa-lpc metabolism within the plaque.


Eligibility criteria:
inclusion criteria: * patients who have provided explicit consent * patients older than 18 years * patients about to undergo surgery for carotid stenosis * haemoglobin ≥ 7g/dl at the time the sample is taken * respect the maximum volume of blood taken (treatment + research) in 30 days specific to diabetics - patients with type 1 or 2 diabetes diagnosed more than 6 months earlier exclusion criteria: * patients under guardianship * patients without health insurance cover * pregnant or breast-feeding women
afatinib plus nimotuzumb for nsclc

Conditions: NSCLC

Summary: to find the optimal dose of afatinib and nimotuzumab in patients who acquired resistance to gefitinib or erlotinib.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of stage iiib or iv nsclc * presence of egfr sensitizing mutations (l858r mutation in exon 21 or exon 19 deletion) or response by recist on prior gefitinib or erlotinib or stable disease on prior gefitinib or erlotinib for at least 6 months * disease progression on treatemtn with gefitinib or erlotinib within 30 days * biopsy on disease progression * age ≥20 years * ecog performance status of 0, 1, or 2 * measurable disease by the criteria of recist 1.1 * adequate organ function as evidenced by the following; absolute neutrophil count \> 1.5 x 109/l; platelets \> 100 x 109/l; total bilirubin ≤1.5 unl; ast and/or alt \< 5 unl; creatinine clearance ≥ 45 ml/min exclusion criteria: * known interstitial lung disease * prior treatment with egfr targeting antibodies or bibw 2992 * prior three or more lines of chemotherapy for advanced nsclc * significant bowel disease impairing drug absorption * uncontrolled systemic illness such as dm, chf, unstable angina, hypertension or arrhythmia * have symptomatic, untreated, or uncontrolled central nervous system (cns) metastases. patients with treated cns metastases are eligible provided their disease is radiographically stable, asymptomatic, and corticosteroid use has been discontinued for at least 2 weeks prior to the first dose of study drug. screening of asymptomatic patients without history of cns metastases is not required.

Keywords: acquired resistance gefitinib erlotinib
upfront eus cgn/cpn vs conventional step up approach for inoperable painful pancreatic cancer

Conditions: Pancreatic Cancer Non-resectable; Tumor Pancreas; Pain Cancer

Summary: patients with unresectable pancreatic cancer are often demoralized by intractable, persistent and incapacitating pain. it must be managed aggressively and strong opioids are recommended as the mainstay of treatment. however, patients develop opioid-related adverse effects. eus-guided celiac plexus neurolysis (cpn) and celiac ganglion neurolysis (cgn) has been shown to provide high efficacy for pain control. the optimal timing, however, is in debate.


Eligibility criteria:
inclusion criteria: 1. age \>= 18 years old 2. diagnosed to have inoperable pancreatic cancer 3. presence of tumor pain (centrally located, constant, with no other obvious cause) with a vas \>= 3 4. karnofsky performance status \>= 60 5. planned for eus examination and/or biopsy of the pancreatic tumor exclusion criteria: 1. allergy to bupivacaine, or alcohol 2. potentially operable after neoadjuvant therapy 3. expected survival of less than 3 months 4. patient who is already on opioids for pain control 5. previous percutaneous or eus-guided cgn/ cpn 6. recurrent pancreatic tumors after operation 7. uncorrectable coagulopathy 8. inability or unwillingness to provide informed consent

Keywords: pancreatic cancer non-resectable tumor pain endoscopic ultrasound-guided celiac ganglion neurolysis