Kornimate/medical-research-clean huggingface dataset:
study of an investigational drug for the prevention of thrombosis-related events following knee replacement surgery

Conditions: Deep Vein Thrombosis; Pulmonary Embolism

Summary: the purpose of this study is to learn whether apixaban prevents the development of blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism), which sometimes occur after knee replacement surgery, and to compare the efficacy of apixaban with that of enoxaparin (lovenox®) in the prevention of these clots. the safety of apixaban will also be studied.


Eligibility criteria:
key inclusion criteria * patients scheduled for either elective unilateral or same-day bilateral total knee replacement surgery (tkr) or a revision of at least 1 component of a tkr * patients willing and able to undergo bilateral ascending contrast venography key exclusion criteria * known or suspected hereditary or acquired bleeding or coagulation disorders in the participant or his or her first-degree relative * known or suspected history of heparin-induced thrombocytopenia * known coagulopathy * active bleeding or at high risk for bleeding * brain, spinal, ophthalmologic, or major surgery or trauma within the past 90 days * active hepatobiliary disease * alcohol and/or substance abuse within the past year * any condition for which, in the opinion of the investigator, surgery or administration of an anticoagulant was contraindicated * two consecutive blood pressure readings within 15 to 30 minutes with supine systolic blood pressure \>180 mm hg or supine diastolic blood pressure \>105 mm hg * clinically significant laboratory abnormalities at the enrollment visit: * hemoglobin \<10 g/dl * platelet count \<100,000/mm\^3 * creatinine clearance \<30 ml/min, as estimated by the method of cockcroft and gault * alanine aminotransferase or aspartate aminotransferase level \>2\*upper limit of normal (uln) or a total bilirubin ≥1.5\*uln (unless an alternative causative factor such as gilbert's syndrome was identified)

Keywords: prevention of deep vein thrombosis and pulmonary embolism after total knee replacement surgery
assessment of customized 3d zirconium versus titanium mesh for anterior maxillary ridge augmentation with delayed implant placement

Conditions: Ridge Augmentaton and Dental Implants; Bone Loss, Alveolar

Summary: the aim of the present study is to assess the customized 3d zirconium versus titanium mesh for anterior maxillary ridge augmentation with delayed implant placement.


Eligibility criteria:
inclusion criteria: * inclusion criteria: 1. patients from both genders with the age range of 18-60 years with good systemic health, no contraindication for periodontal surgery and able to maintain good oral hygiene. 2. patient with anterior maxillary alveolar ridge deficiency (horizontal, vertical or combined defects) less than 2 mm in width or less than 6 mm in height - measured from the alveolar crest to the basal bone in order to be enrolled in this study. (56) 3. adequate zone of keratinized gingiva at minimum 3mms. 4. patient with sufficient inter-arch space for future dental rehabilitation. 5. subjects who are not on any medication known to interfere with periodontal tissue health or healing within 6 months of the study. exclusion criteria: exclusion criteria: 1. history of systemic diseases (i.e. diabetes, autoimmune dysfunction, prolonged cortisone therapy, or chemotherapy) that would contraindicate periodontal surgical treatment or affect bone turn over. 2. patients with deleterious habits like the use of tobacco chewing or smoking ones. 3. history of previous periodontal surgical treatment of the involved sites. 4. presence of malocclusion and pathologic movement of teeth in involved sites. 5. patient not willing to give consent for the study and poor plaque control.(57) 6. pregnant or nursing mothers. 7. patients with acute odontogenic infection.

Keywords: ridge augmentation dental implant titanium mesh zirconium mesh
a study to assess dv-601 in subjects with chronic hepatitis b

Conditions: Hepatitis B, Chronic

Summary: the purpose of this study is to determine if dv-601, an investigational, therapeutic vaccine will be well-tolerated and induce hepatitis b virus (hbv)-specific virological and immunological responses in chronic hepatitis b (chb) patients.


Eligibility criteria:
inclusion criteria: * male and female subjects 18 to 65 years of age. * signed informed consent. * diagnosis of chb and candidates for therapy * normal renal function * women of childbearing potential must have a serum negative pregnancy test at screening. women of childbearing potential and males whose sexual partners are of childbearing potential must agree to use dual methods of contraception. exclusion criteria: * liver disease other than chb * documented co-infection with hepatitis a virus (hav), hepatitis c virus (hcv), or hiv * previous therapy with interferon alpha. * any other antiviral therapy for chronic hepatitis b within the previous 3 months prior to screening visit. * immunosuppressive treatment (e.g. chemotherapy, high-dose of steroids) within 6 months of screening visit. * evidence of cirrhosis * child-turcotte-pugh (ctp) score ≥ 7, either currently or at any occasion in the past * clinically significant acute or chronic illnesses, such as autoimmune diseases, collagen vascular disease, immune deficiencies, active or uncontrolled infections, etc. as determined by the investigator and documented in medical history. * malignancy other than curatively treated, superficial skin cancer or carcinoma in situ of the cervix. * participation in any experimental protocol or therapy within 28 days prior to the screening visit. * current substance or alcohol abuse that in the opinion of the investigator would interfere with compliance or with interpretation of study results.

Keywords: dv-601 hepatitis b entecavir therapeutic vaccine
perioperative outcomes of anatomic lung resections in patients who recovered from coronavirus disease 2019

Conditions: COVID-19; Lung Cancer; Lung TB; Hemoptysis

Summary: this study will determine the outcomes of anatomic lung resections in patients who recovered from coronavirus disease 2019 (covid-19) disease by describing the morbidity and mortality as well as the length of postoperative hospital stay.

this study will be conducted at the lung center of the philippines. the study design is a retrospective case series implemented via chart review. online and written patient records will be reviewed to determine the baseline patient characteristics and the preoperative outcomes. patients who recovered from covid-19 will be selected from those who underwent anatomic lung resection from june 1, 2020 to may 31, 2022. this study will be done in accordance with the helsinky declaration and good clinical practice guidelines, and will be subject for approval of the institutional ethics and technical review boards. descriptive statistics will be used to describe patient characteristics and perioperative outcomes.

Eligibility criteria:
inclusion criteria: * underwent anatomic lung resection * previous covid-19 infection documented by nasopharyngeal swab rt-pcr or genexpert * with negative nasopharyngeal swab rt-pcr or genexpert prior to lung resection exclusion criteria: * with incomplete patient records
validation of a smartphone-based assessment of movement health

Conditions: Mobility Limitation

Summary: to correlate a smartphone-based assessment of mobility, stability, and posture with those derived from standard clinical tests among a heterogeneous cohort.

smartphone movement health assessment introduces a new measure of health that helps users analyze and improve their mobility, stability and posture through performance of movements and physical exercises. to verify the accuracy of this measure, the goal is to provide data-driven evidence regarding its accuracy in comparison to gold standard tests for measuring movement health. to address this challenge, the assessment scores will be benchmarked to a set of gold standard tests and sensor metrics for measuring movement health recommended by professional associations such as the american physical therapy association (apta) or american college of sport medicine (acsm) and found valid in clinical studies , .

Eligibility criteria:
inclusion criteria: 1. all participants should be able to perform the smartphone movement health assessment and receive a score for their movement health. this will be evaluated by the research team members during the recruitment process. 2. ages 18-85 years old 3. able and willing to give written consent and comply with study procedures exclusion criteria: 1. pregnant or nursing 2. skin allergies or irritation that would prevent safe use of sensors described in protocol
single anastomosis sleeve jejunal (sas-j) bypass

Conditions: Morbid Obesity

Summary: the purpose of this study is to determine the efficacy of single anastomoses sleeve jejunal bypass as a treatment for morbid obesity

in this study the investigators aim to test a new technique ( single anastomoses sleeve jejunal as a treatment for morbid obesity which is a modification of single anastomoses sleeve ileal bypass with short biliary limb ( about one third of the small intestine from the duodeno-jejunal junction

Eligibility criteria:
inclusion criteria: * obese patients with bmi more than 40 * patients fit for laparoscopic surgery * give approval to share in the study exclusion criteria: * patients refused to share in the study * patients unfit for surgery * patients aged less than 18 and older than 50 * patients with bmi less than 50 * patient with previous upper abdominal surgery either for obesity or other diseases * patients with preoperative gerd clinically or by investigation
hereditary angioedema, neurobiology and psychopathology

Conditions: Hereditary AngioEdema; Anxiety; Depression

Summary: since 1963 hereditary angioedema (hae) is considered an autosomal dominant disorder (donaldson and evans), characterized by a quantitative and/or qualitative deficit of c1 esterase inhibitor (c1-inh), which affects approximately 1:50.000 individuals in the general population. from this period the link between hae and psychiatry was interrupted, however genetic issues could not comprehensively explain the clinical evolution of the disease. clinical studies show an evident gap between genotype and phenotype of hae. for this still controversial question, we have designed this cross-sectional study in order to establish the relationship between hae clinical manifestations and neurobiological/psychopatological parameters.


Eligibility criteria:
inclusion criteria: diagnosis of hae exclusion criteria: * current pharmacological treatment including ace-inhibitors, ace inhibitors, glucocorticoids, oestroprogestative, psychotropic drugs, drugs acting on the immune system (15 days before), anesthetics (in the previous three months). * inflammation / infection (eg, chronic inflammatory diseases, acute) in the last 15 days. * ongoing allergies. * night work over the past 15 days. * vigorous physical activity or alcohol consumption (the day before the assessment). * women in follicular phase of menstrual cycle.
prostate specific antigen levels of individuals living in rural areas

Conditions: Prostate Carcinoma

Summary: it was planned in cross-sectional design in order to determine the specific prostate antigen level and some characteristics and the relationship evaluations and prostate specific antigen formation in individuals living in rural areas. it was planned to perform socio-demographic information formula, form including social information of health, prostate specific antigen test in the project data recording.

it was planned in a cross-sectional design to evaluate the prostate specific antigen level and its relationship with some characteristics in elderly individuals living in rural areas and to determine the prostate specific antigen level. the research area of the project consists of 8 villages. in the collection of project data, it was planned to conduct a socio-demographic feature information form, a form including social determinants of health, and a prostate specific antigen test. this planned project is the first research to be conducted in our country in terms of determining risky groups, ensuring randomness in participants, and sampling method for universe representation. in addition, screening the rural area, which is disadvantaged in terms of socio-economic and demographic aspects, and preferring elderly individuals constitute the steps taken to ensure health equality of the disadvantaged group in terms of health service transportation opportunities.

Eligibility criteria:
inclusion criteria: * male * 55 years or older exclusion criteria: -prostate treatment

Keywords: prostate carcinoma, screening
neoadjuvant and adjuvant chemotherapy in high-risk soft tissue sarcoma

Conditions: Soft Tissue Sarcoma

Summary: neo- and adjuvant chemotherapy is used in high-risk soft tissue sarcoma to improve systemic control. patients in this trial are treated with 4 cycles of chemotherapy (eia, etoposide, ifosfamide, adriamycin) preoperatively, followed by local surgery and radiotherapy. an additional 4 cycles of adjuvant chemotherapy is administered. treatment response is assessed by mri and ct scans and fdg-pet in a subgroup of patients.

the role of chemotherapy in high-risk soft tissue sarcoma is controversial. though many patients undergo initial curative resection, distant metastasis is a frequent event resulting in 5-year overall survival rates of only 50 - 60%. neo-adjuvant and adjuvant chemotherapy has been applied to achieve pre-operative cytoreduction, assess chemosensitivity and to eliminate occult metastasis. the current protocol comprises for cycles of neoadjuvant chemotherapy ((eia, etoposide 125 mg/m2 iv days 1 and 4, ifosfamide 1500 mg/m2 iv days 1 - 4, doxorubicin 50 mg/m2 day 1, pegfilgrastim 6 mg sc day 5), local surgery and radiotherapy as well as further 4 cycles of adjuvant eia. treatment response is assessed by mri and ct scans and fdg-pet in a subgroup of patients.

Eligibility criteria:
inclusion criteria: * soft tissue sarcoma histology * tumor size \>= 5 cm * deep/extracompartimental localization * grade 2/3 (fnclcc) * patients with inadequate previous therapy * age 18-65 years * normal bone marrow function * normal liver function * normal renal function * karnofsky index \>=80% exclusion criteria: * chordoma * chondrosarcoma * kaposi´ sarcoma * neuroblastoma * mesothelioma * osteosarcoma/ewings´sarcoma

Keywords: soft tissue sarcoma high-risk neoadjuvant adjuvant chemotherapy radiotherapy
delaying the onset of nearsightedness until treatment study

Conditions: Myopia

Summary: participants eligible for the study will be randomized to one of three concentrations of atropine and followed for a month.

participants will be identified through screening that fit the criteria of a pre-myopic child, which will depend on age and the amount of refractive error at that time. these children will be randomized for a pilot study measuring compliance in nightly eye drop administration. the outcome will be thirty days after randomization, and will assess whether or not there is a difference in compliance between one of three dosages of atropine (0.01%, 0.03%, and 0.05%).

Eligibility criteria:
inclusion criteria: * age: 6-11 years * refractive error measured in spherical equivalent, one eye meets criterion * 6 years old: 0.50 to +0.38 * 7 years old: 0.50 to +0.25 * 8-11 years old: 0.50 to plano * anisometropia: spherical equivalent \<1.50 d * astigmatism: \<1.50 in both eyes * myopia: less myopic than -0.74 d, both eyes exclusion criteria: ● myopic
vessel density in namd after longterm anti-vegf treatment compared to recently started anti-vegf treatment

Conditions: Neovascular Age-related Macular Degeneration

Summary: neovascular age-related macular degeneration (namd) is characterized by the abnormal growth of blood vessels from the choroid into the subretinal space which leads to sub- and intraretinal fluid accumulation, hemorrhages and subretinal fibrosis with progressive loss of central vision. intravitreal anti-vegf treatment is the standard of care. intravitreal anti-vegf application might temporarily increase intraocular pressure due to a volume effect. it remains unclear if repeated injections might have an impact on retinal capillary perfusion. therefore this study aims to investigate the vascular microcirculation differences between patients who received longterm intravitreal anti-vegf treatment and patients who recently started anti-vegf treatment using optical coherence tomography angiography (octa).

main outcome parameters are: * vessel perfusion area (%) of central etdrs subfields and peripapillar region as evaluated by octa (single measurement) * blood flux index(\*) of central etdrs subfields and peripapillar region as evaluated by octa (single measurement). * peripapillary and perifoveal retinal nerve fiber layer (rnfl) thickness (µm) as evaluated by oct (single measurement) * intraocular pressure (iop) (mmhg) (single measurement at study visit) and mean intraocular pressure during anti-vegf treatment period (evaluated as mean of all retrospectively available iop measures from the beginning of treatment, mmhg) (\*)blood flux index is automatically calculated by ari network as the mean flow intensity in the vessel area, where the blood flow signal was normalized to 0 to 1 by dividing by the full dynamic range of blood flow signal intensity.

Eligibility criteria:
inclusion criteria: to be eligible for participation, patients will be required to * have been treated for sub- or juxtafoveal cnv due to namd with anti-vegf intravitreal injections either for at least 20 times (longterm treatment eyes) or \<5 times (shortterm treatment eyes). * give written consent to participation exclusion criteria: * diagnosis of glaucoma/ocular hypertension at baseline of anti-vegf treatment * history of retinal vascular disorders like diabetic retinopathy, retinal vein/arterial occlusive disease, uveitis etc. * history of papillary disease which might interfere with interpretation of peripapillary oct/octa evaluation such as severe tilted disc, parapapillar cnv, papillar drusen, optic nerve neuritis, papillar edema etc. * inability to perform octa examination of sufficient quality. * history of any side effects of tropicamide eye drops
a study to evaluate the safety and efficacy of jnj-64565111 in severely obese participants with type 2 diabetes mellitus

Conditions: Obesity and Diabetes Mellitus, Type 2

Summary: the purpose of this study is to assess the effects of jnj-64565111 compared with placebo in severely obese type 2 diabetes mellitus (t2dm) participants after 12 weeks of treatment on: the percentage change in body weight from baseline and safety and tolerability.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) greater than or equal to (\>=) 35 to less than or equal to (\<=) 50 kilogram per meter square (kg/m\^2) at screening * stable weight (that is, change of \<= 5 percent \[%\] within 12 weeks before screening based on medical or participant reported history) * hemoglobin a1c of \>= 6.5% and \ = 12 weeks prior to screening; (b) on stable dose of single oral antihyperglycemic agent (aha) or dual-combination oral ahas for \>= 12 weeks prior to screening * women must be either: (a) postmenopausal, or (b) permanently sterilized or otherwise be incapable of pregnancy, or (c) heterosexually active and practicing a highly effective method of birth control, or (d) not heterosexually active * willing and able to adhere to specific the prohibitions and restrictions exclusion criteria: * history of obesity with a known secondary cause (example, cushing's disease/syndrome) * history of type 1 diabetes mellitus, diabetic ketoacidosis, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy * fasting c-peptide less than (\<) 0.7 nanogram per milliliter (ng/ml) at screening * fasting fingerstick glucose of \>= 270 milligram per deciliter (mg/dl) (\>=15 millimoles per liter \[mmol/l\]) on day 1 * ongoing, inadequately controlled thyroid disorder as assessed by the investigator's review of the participant's medical history. participants taking thyroid hormone replacement therapy must be on stable doses for at least 6 weeks before the screening visit
using romiplostine for persistent thrombocytopenia with transfusion-dependent patients who received allogeneic hematopoietic stem cell

Conditions: Persistent Thrombocytopenia Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Summary: this is a phase i/ii multicenter study which aims to assess the toxicity profile of romiplostim in patients with transfusion-dependent thrombocytopenia after allogeneic hsct. a total of 24 patients with transfusion-dependent thrombocytopenia after allogeneic hsct will be included. the main endpoint is the incidence and severity of adverse events.


Eligibility criteria:
inclusion criteria: * subjects must be ≥ 18 years, willing and able to sign informed consent * patients could have been transplanted for hematological disorder (malignant or non-malignant) excepted myelodysplastic syndromes patients and had received either a myeloablative or a reduced intensity conditioning. all sources of allogeneic stem cells are allowed. * prolonged (\> 2 months) transfusion-dependent thrombocytopenia * screenings mean platelet count≤ 20 x giga/l or screenings mean platelet count ≤ 50 x giga/l with a history of bleeding. * (ecog) performance status of 0-2 * adequate liver function * serum creatinine ≤ 176.8 μmol/l * bone marrow aspirate with cytogenetics within 6 days of the first dose of romiplostim * written informed consent exclusion criteria: * relapse/progression of hematological malignancy (marrow examination required) * non-controlled acute and/or chronic graft versus host disease (gvhd) * active or uncontrolled infections * cardiac pathology - thrombosis * pregnancy or breast feeding * received interleukin-11 (il-11) within 4 weeks of screening or previously received any thrombopoietic growth factor * patients on anticoagulant therapy * receipt or planned receipt of pegylated granulocyte colony stimulating factor (peg-g-csf), or granulocyte macrophage-colony stimulating factor (gm-csf) within 4 weeks of the first dose of investigational product * subject not using adequate contraceptive precautions, in the judgment of the investigator * sensitivity to any escherichia coli-derived product * inability to comply with study procedures. * subject currently is enrolled in or has not yet completed 30 days since ending other investigational device or drug study * no medical insurance in the french health system