Kornimate/medical-research-clean huggingface dataset:
a phase i study of js108 in patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this is a phase i, open-label, first-in-human clinical study designed to evaluate the safety, tolerability, pk profile and efficacy of js108 for patients with advanced solid tumors. this study is divided into 3 periods: dose escalation period, dose expansion period, and clinical expansion period.


Eligibility criteria:
1. volunteer to sign an informed consent form. 2. age of 18-75 years (inclusive), male or female; 3. expected survival ≥3 months; 4. histological or cytologically confirmed locally advanced or metastatic solid tumors which progressed on standard of care or with no standard of care available; 5. toxicity of previous antitumor therapy has recovered to ≤ grade 1 as defined by the nci-ctcae v5.0, except alopecia; 6. subjects dose expansion period and clinical expansion period must have at least one measurable lesion in accordance with recist v 1.1; 7. eastern cooperative oncology group (ecog) performance status score: 0 or 1; 8. subjects must be able to provide fresh or archived tumor tissue obtained within 1 year prior to inclusion in the study； 9. the organ function level must meet the protocol requirements； 10. serum pregnancy test confirmed as negative for women of childbearing potential within 7
in vivo kinematics for subjects implanted with klassic total knee arthroplasty (tka)

Conditions: Total Knee Arthroplasty; Osteo Arthritis Knee; Knee Implant; Knee Injuries

Summary: in vivo knee kinematics will be assessed for 20 subjects that have been implanted with a total joint orthopedics klassic knee system by dr. aaron hofmann of the hofmann arthritis institute's center for precision joint replacement. this is the location from which all participants will be recruited and where fluoroscopy data collection will occur. participants will undergo fluoroscopic surveillance of their implanted knee using a c-arm fluoroscopic unit while performing a deep knee bend activity at least six months post-operatively.

enrollment will be increased to 24 subjects to ensure that researchers acquire the necessary 20 usable datasets for analysis and also to account for any subjects that may drop out of the study. at present, all tka available for surgeons to use are asymmetric where there is a distinct femoral and tibial component for the left knee and a distinct femoral and tibial component for the right knee. the klassic knee system is a symmetrical knee implant, where the same femoral and same tibial component can be used for either the right or left knee. the kinematics for the 20 knees will be analyzed, including condylar roll-back, axial rotation, range of motion, and condylar lift-off

Eligibility criteria:
inclusion criteria: 1. subjects will have a klassic knee system. 2. subjects must be at least six months post-operative. 3. participants must be judged clinically successful with their most recent (new) knee society "knee score" equal to or greater than 80. 4. participants must be able to perform a deep knee bend. 5. subjects must be willing to sign the informed consent (ic) / hipaa form to participate in the study. 6. must speak english. exclusion criteria: 1. pregnant, potentially pregnant or lactating females. to satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. a pregnant person will not be allowed to participate in the study. 2. subjects without the required type of knee implant. 3. bilateral subjects (i.e., patients with both knees implanted) 4. subjects who are unable to perform a deep knee bend. 5. subjects who are unwilling to sign informed consent/ hipaa documents. 6. subjects who do not speak english

Keywords: total knee arthroplasty knee implant osteoarthritis
comparison of the absorption of calcium citrate and calcium carbonate in patients with an rygb, lsg, and oagb

Conditions: Calcium Citrate Absorption; Calcium Carbonate Absorption

Summary: the precise impact of calcium absorption in relation to rygb, sg, and oagb remains under-researched in terms of statistical power and the diversity of bms procedures considered. therefore, this presents a critical area for future investigation to improve patient outcomes in bms.

calcium, predominantly absorbed in the duodenum and proximal jejunum, relies heavily on vitamin d and an acidic environment to facilitate absorption. with the increasing prevalence of bariatric metabolic surgery (bms) procedures and their malabsorptive effects, the likelihood of fat-soluble vitamin malabsorption becomes heightened. this stems from bypassing the stomach, key absorption sites in the intestine, and the inefficient mixing of bile salts. bms is often associated with several bone metabolism disorders, including the acceleration of bone remodeling and turnover, bone loss, and decreased bone mineral density (bmd). postoperative calcium supplementation can mitigate this bone loss over time. for instance, a study demonstrated the beneficial effect of calcium citrate following roux-en-y gastric bypass (rygb). however, the study's statistical power was insufficient; thus, the bms field still awaits further conclusive and robust research to establish definitive guidelines, which was highlighted in another study. moreover, substantial changes in gut hormones, such as peptide yy (pyy), glucagon-like peptide-1, and ghrelin, have been observed following rygb, sleeve gastrectomy (sg), and one anastomosis gastric bypass (oagb). while these hormonal changes are typically associated with bms's numerous positive metabolic benefits, they may also contribute to bone loss. consequently, the precise impact of calcium absorption in relation to rygb, sg, and oagb remains under-researched in terms of statistical power and the diversity of bms procedures considered. therefore, this presents a critical area for future investigation to improve patient outcomes in bms.

Eligibility criteria:
inclusion criteria: * patients aged 18-75 years old * after bms surgery who had an rygb, sg, or oagb operation at least 12 months before the study. * patients will be selected at random from the hospital's electronic patient system. exclusion criteria: * patients on antacids during the study * patients onh2 receptor antagonists during the study * patients on proton pump inhibitors during the study * patients with a previous oophorectomy, * liver disease, * renal disease, * hypercalcemia, * hyperthyroidism, * hypothyroidism who require levothyroxine supplementation (levothyroxine forms complexes with calcium) * parathyroid disorders * use of diuretics, * use of calcitonin, * use of corticosteroids, * use of anabolic steroids, * use of anticonvulsants within three months of the study * heavy smokers (\>10 cigarettes/day) * abusing alcohol (\>70 ml/day)

Keywords: calcium citrate bariatric surgery absorption calcium carbonate
pre-operative study of pf-4691502 with letrozole compared to letrozole alone in patients with early breast cancer

Conditions: Early Breast Cancer (Phase 2); Advanced Breast Cancer (Phase 1b)

Summary: pf-04691502 is an inhibitor of pi3k and mtor kinase. published data support the hypothesis that a pi3k/mtor antagonist in combination with letrozole might mitigate the intrinsic or acquired resistance to hormonal therapy and restore hormone sensitivity in high risk (high ki-67) patient population of hormone-sensitive breast cancers. in addition, ki-67, a marker of cellular proliferation, could be used to select those patients who benefit from treatment with a pi3k-pathway inhibitor.

the study was prematurely discontinued on 09oct2012 due to the tolerability findings in 2 clinical studies testing pf-04691502 that have prompted the sponsor to re-evaluate the strategic goals of the program. in the study b1271003 an unexpected frequency of severe skin toxicity was observed and in the study b1271004 5 cases of drug induced pneumonitis were reported.

Eligibility criteria:
inclusion criteria: * phase 1 - postmenopausal women with diagnosis of breast cancer, metastatic disease or locally advanced disease / estrogen receptor positive and her-2 negative / candidate to receive letrozole * phase 2 - postmenopausal women with newly diagnosed primary breast cancer / estrogen receptor positive and her-2 negative / ki-67 levels \>10% positive cells * phase 1 \& 2 - glucose control, adequate bone marrow, liver, renal, and cardiac function exclusion criteria: * inflammatory carcinoma / prior therapy with an agent active on pi3k and/or mtor / significant gastrointestinal abnormalities, which may impair intake, transit or absorption of the study drugs / current or anticipated need for food or drugs that are known inhibitors or inducers of cyp3a4

Keywords: ki-67 postmenopausal early breast cancer er positive/her2 negative early breast cancer
lidocaine versus esmolol for optimizing surgical field visibility

Conditions: Lumbar Disc Herniation

Summary: intra-operative blood loss is an important attribution and predictor of the lumbar spine surgery and patient outcome. stripping the muscle off bone makes more exposed bleeding spine surface is one of causes for blood loss during lumbar surgeries. the importance to decrease the bleeding is to improve the surgical field visibility which provides technical ease for surgeon and decreases the surgical time besides maintaining the hemodynamic stability. in past, there were many trials to minimize surgical blood loss by different drugs such as na nitroprusside, magnesium sulfate, volatile anesthetics and beta-adrenergic antagonist.

sample size: assuming mean and standard deviation of mean arterial pressure in lidocaine group versus esmolol group is 90±27.9 versus 73± 22.5 so the sample size will be 70 (35 in each group ) using open epi program with confidence level 95%, power of test 80% all patients will be hospitalized and visited a day before the surgery, full history with physical examination and routine investigation will be done, the nature and complications of the study will be explained in detail to the patient and informed written consent will be obtained from every participant. all patients will be kept nil orally 6 hours before the operation. all surgeries will be done by the same surgeon to decrease observer's bias. the surgeon and the outcome assessor (anesthesiologist collect the data) will be blinded to study drugs. using computer generated randomization table, each group consists of 35 patients.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologist( asa): i\& ii physical status: * body mass index( bmi)=(25-35 kg/m2). * type of operations: lumbar discectomy. * written informed consent from the patient. exclusion criteria: * patient refusal. * .altered mental state * . patients on beta-blockers or with a known history of allergy to study drugs. * hepatic, renal, cardiovascular and respiratory diseases. * diabetic patients. * patients receiving anticoagulants. * previous spine surgery

Keywords: esmolol lidocaine surgical field
comparison of three transfusion strategies for central venous catheterization in cirrhotics: a randomized clinical trial

Conditions: Liver Cirrhosis

Summary: the aim of this study is to compare three different blood transfusion strategies for coagulopathy correction before central venous catheterization in patients with chronic liver failure (cirrhosis and/or chronic liver graft dysfunction) admitted in intensive care unit.

central venous catheterization is a ubiquitous procedure in intensive care units and is mainly used for drug administration, hemodynamic monitoring and hemodialysis. only in us more than five million catheters are inserted annually. one of the main complications associated to central venous lines are the mechanical ones, i.e. arterial puncture, bleeding and hematoma formation, which varies between 5% and 19%. the use of real-time ultrasonography to accomplish central venous catheterization was associated to a drastic reduction in complication rates, and when performed by trained personnel, some series show complications rates \<1%, even in patients with coagulopathy. patients presenting with chronic liver failure has a complex coagulation system balance, resulting from reduction in the majority of procoagulant and anticoagulant factors, opposed by preservation of thrombin generation. thus, these patients are prone to develop hemorrhagic and thrombotic phenomena. the coagulation of cirrhotic patients have been classically evaluated by standard coagulation tests. nevertheless, these tests present important limitations, as evaluation of plasmatic component only, and do not predict bleeding risk. the thromboelastometry is a point-of-care real-time coagulation system evaluation with the advantage of evaluating the cellular and plasmatic components of the coagulation and present a more comprehensive evaluation of blood coagulation, specially in cirrhotics. this technology is associated with reduced costs in diverse clinical settings. in clinical practice, approximately 90% of physicians empirically transfuse blood components to cirrhotic patients before invasive procedures. this practice is associated to increased risks related to blood transfusion per se, e.g. blood borne infections, immunologic and non-immunologic adverse reactions, to cite some. several randomized clinical trials have shown that restrictive blood transfusion strategies are associated to better outcomes, including mortality.

Eligibility criteria:
inclusion criteria: * chronic liver failure (cirrhosis or chronic graft dysfunction) from any cause and medical indication of central venous line placement exclusion criteria: * acute liver failure or * use of therapeutic doses of oral or parenteral anticoagulants (unfractionated heparin or low molecular weight heparin or oral anticoagulants) or * use of oral or parenteral platelet aggregation inhibitors or * patients with von willebrand syndrome or * over-the-guidewire central venous catheter changing * patients previously included in this study protocol during the same hospital stay

Keywords: liver cirrhosis blood coagulation thromboelastography blood transfusion catheterization, central venous
functional electrical stimulation cycling in sci

Conditions: Spinal Cord Injury, Acute; Paraplegia; Tetraplegia

Summary: spinal cord injury (sci) is a devastating, life-altering injury; requiring tremendous changes in an individual's lifestyle. cycling, provides an ideal way for individuals with sci to exercise and address the long-term consequences of sci by targeting the lower extremity muscles. cycling with the addition of functional electrical stimulation (fes) allows persons with paralysis to exercise their paretic or paralysed leg muscles. the queen elizabeth national spinal injury unit (qensiu) in glasgow offers fes cycling for people with spinal cord injuries, which combines functional electrical stimulation (fes) with a motorised ergometer that allows repetitive cycling activity. it stimulates muscles with electrodes attached to the skin, producing muscle contractions and patterned activity. so far no previous randomised control trials on fes cycling in the acute sci population have reported changes in ability to undertake activities of daily living or the trunk balance.

up to 12 participants admitted to the qensiu will be recruited to the study. they will be randomised to the intervention (n=8) or control group (n=4). the intervention group will receive 6 weeks fes cycling training in addition to usual care; the control group will receive usual care only. outcome measures: spinal cord injury functional ambulation inventory, the spinal cord independence measure, asia impairment scale, handheld dynamometry, 10-metre walking test, timed up and go test, trunk impairment scale, modified ashworth scale, modified tardieu scale, the patients global impression of change.

Eligibility criteria:
inclusion criteria: * identified as being medically stable by the treating consultant, * within the first 6 weeks post-injury, * able to sit for 2 hours in a wheelchair, * over 18 years old, * acquired non progressive sci - traumatic, spinal cord stroke, surgical injury, * an incomplete sci, graded as american spinal injury association (asia) b (motor complete, sensation present below the lesion); c (some but not useful motor function) or d (useful motor function present), exclusion criteria: * acute condition impairing participant's ability to cycle (eg, leg fracture), * proven or suspected neuromuscular weakness affecting the legs due to another condition (eg, stroke or guillain-barré syndrome), * unable to follow instruction in english * symptomatic cardiac disease, * ventilator dependency, * severe spasticity, * uncontrolled autonomic dysreflexia, * possible, suspected or confirmed pregnancy, * likely to be discharged before the end of the exercise intervention. * unable to tolerate the sensation of fes

Keywords: functional electrical stimulation cycling physical therapy
efficacy and safety of paliperidone er in first episode psychosis

Conditions: First Episode Psychosis

Summary: the aim of the study is to investigate the efficacy and safety of paliperidone er in patients with first episode psychosis.


Eligibility criteria:
inclusion criteria: * aged 18-59 years and meet dsm-iv diagnostic criteria for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder nos as assessed by using the structured clinical interview for dsm-iv, research version. exclusion criteria: * meeting dsm-iv criteria for another axis i diagnosis, including substance abuse or dependence * needing another nonantipsychotic psychotropic medication at enrollment * having a serious or unstable medical illness. * pregnant or lactating women or women without adequate contraception will be also excluded.
an open, randomized, multicentre, phase ii pilot study

Conditions: Non-Small Cell Lung Cancer

Summary: the objective of this study is to evaluate efficacy, safety and quality of life adjuvant docetaxel-cisplatin chemotherapy versus no adjuvant treatment in patients with completely resected nsclc stage i-ii.

open multicentre, centrally randomized, two-arm parallel-group, phase ii pilot-study. duration of the treatment : arm a - will be 4-6 cycles docetaxel 75mg/m2 and cisplatin 75mg/m2 on day 1 every 21 days. arm b untreated control group - best supportive care. a follow-up check-up examination will be performed every 3 months for a total of three years.

Eligibility criteria:
inclusion criteria: * histologically documented nsclc stage i-ii * complete resection of tumor amd resection margins microscopically tumor free. * surgical procedure: according to necessity for oncology radicality a lobectomy, bilobectomy or pneumectomy will be performed with either radical mediastinal lymphadenectomy or complete sampling of all relevant lymph node areas. * randomization within 60 days after surgical required. * initial work-up * general conditions: 19-70 years, who performance status 0-2, adequate hematological function, adequate renal and hepatic function, negative pregnancy test. exclusion criteria: * nsclc stage ii-iv, sclc or alveolar carcinoma * clinical evidence of cns metastases * pregnant and lactating patients * past or concurrent history of malignancies other than nsclc,except for curatively treated non melanoma of the skin or in situ cervical carcinoma or other curatively treated cancer with no evidence of disease for at least five years. * prior or concurrent antitumor therapy for nsclc other than surgery. * concomitant participation in clinical studies of non-approved experimental agents or procedures. * major complications after surgery * serious concomitant medical conditions * psychological,familial, sociological or geographical conditions which do not permit compliance with the study protocol

Keywords: nsclc docetaxel
effect of psychedelic vr-augmented therapy on patients with clinical depression

Conditions: Depression

Summary: research has demonstrated that psychedelic compounds possess significant therapeutic potential for a variety of disorders, including depression. despite these findings, the underlying mechanisms driving the therapeutic efficacy of psychedelics remain elusive. furthermore, there exists a debate over the contribution of the subjective psychedelic experience to their therapeutic benefits. in this study, virtual reality (vr) is utilized as a tool to replicate the subjective experiences induced by psychedelics, aiming to explore their impact on depressive symptoms within a clinical sample. the primary objective of this research is to examine the influence of psychedelic-like phenomenology, as simulated through vr, on depressive symptoms. the study is structured into two distinct arms: the experimental condition features 'psyrreal,' a vr experience designed to emulate psychedelic effects and the control condition which includes 'routine realms,' an analogous vr experience devoid of psychedelic elements. a third waiting list condition may be included, dependent on the availability of sufficient participants and resources. additionally, the study seeks to identify and analyze various potential mediators that might underpin the therapeutic outcomes observed.


Eligibility criteria:
inclusion criteria: * persistent depressive symptoms observed during the initial screening and confirmed at baseline, as determined through a comprehensive psychiatric evaluation. * provision of written informed consent by the participant. * fluent in estonian as a native language. exclusion criteria: * presence of significant impairments in vision, hearing, or balance. * active suicidal ideation or current engagement in self-harm behaviors. note: individuals meeting this criterion will be directed to suitable crisis intervention services. * established diagnosis of bipolar disorder. * manifestation of psychotic symptoms. * history of schizophrenia, either personally or within two generations of the family lineage. * ongoing diagnosis of epilepsy, dementia, or any other neurological condition that could interfere with the effective utilization of virtual reality (vr) technology. * susceptibility to motion sickness.