Kornimate/medical-research-clean huggingface dataset:
osteosynthesis of intraarticular calcaneal fractures: arthroscopically assisted percutaneous technique versus sinus tarsi approach

Conditions: Calcaneus Fracture

Summary: in this randomized controlled trial, the outcomes of two surgical techniques for intraarticular calcaneal fractures will be evaluated and compared.

operative treatment of calcaneal features through an extensile lateral approach (ela) has been the gold standard over many years despite high rates of infection and soft tissue complications. lately, there has been a trend towards less invasive fixation methods. minimally invasive plate osteosynthesis using the sinus tarsi approach (sta) has gained popularity during the last decade. furthermore, percutaneous reduction and fixation techniques have been described and used for a few decades. in the early 2000s, rammelt et al. were the first who introduced a percutaneous technique assisted by hindfoot arthroscopy. the percutaneous and arthroscopically assisted calcaneal osteosynthesis (paco) is applicable in sanders ii and iii fractures and has been shown to provide good clinical outcomes as well as a low rate of complications. the study is designed as a superiority study. our hypothesis is that the percutaneous and arthroscopically assisted technique provides superior outcomes compared to the sinus tarsi approach in sanders ii and iii calcaneal fractures.

Eligibility criteria:
inclusion criteria: * dislocated intraarticular calcaneal fracture, type sanders ii or sanders iii with an intraarticular step \> 2mm * patients between 18 and 70 years of age * acute presentation at one of our departments, enabling surgery within 10 days after injury exclusion criteria: * intraarticular step of \< 2mm * sanders iv fractures * open fractures * bilateral injuries * concomitant major injuries of the foot, ankle or leg that affect the rehabilitation process * multitraumized patients * previous injury or surgery of the hindfoot * charcot foot * serious medical condition that contradicts surgery * noncompliant patients * insufficient norwegian or english language skills * patients not available for follow-up * inability to conduct the rehabilitation protocol

Keywords: calcaneal fracture subtalar arthroscopy trauma calcaneus
modulating prefrontal circuits underlying behavioral flexibility in ocd: a tms study

Conditions: Obsessive-Compulsive Disorder

Summary: this study investigates whether slow-frequency repetitive transcranial magnetic stimulation targeting frontal pole can acutely modulate brain circuits which show abnormal functioning during behavioral flexibility in obsessive-compulsive disorder, as well as performance on a behavioral task.


Eligibility criteria:
inclusion criteria: ocd group * current primary diagnosis of obsessive-compulsive disorder and yale-brown obsessive compulsive scale total score ≥ 16; * 18-55 years of age; * ability to speak, read, write, and understand english sufficiently well to complete study procedures and provide informed consent; * either no use of psychiatric medication or stable psychiatric medication use for 6 weeks prior to study entry, limited to use of serotonin reuptake inhibitors and prn use of benzodiazepines (other psychiatric medication use excluded), and * right-handed. inclusion criteria: healthy control group * 18-55 years of age; * ability to speak, read, write, and understand english sufficiently well to complete study procedures and provide informed consent; * right-handed. exclusion criteria: ocd group * active problematic substance use; * lifetime psychosis or bipolar mood disorder or ocd beliefs of delusional nature; * clinically significant hoarding symptoms; * active suicidal or homicidal ideation; * significant neurological disease or intracranial pathology; * use of medications which increase risk for seizures during tms; * significant or unstable medical disorders or contraindication to tms or mri scan. exclusion criteria: healthy control group * current psychiatric diagnosis; * lifetime psychosis, bipolar mood disorder, or ocd; * active suicidal or homicidal ideation; * significant neurological disease or intracranial pathology; * use of psychiatric medications; * use of medications which increase risk for seizures during tms; * significant or unstable medical disorders or contraindication to tms or mri scan.
supplementation of vitamin d3 in patients with inflammatory bowel diseases and hypovitaminosis d

Conditions: Crohn's Disease (CD); Ulcerative Colitis (UC)

Summary: this study aims to evaluate the effect of vitamin d3 supplementation on disease activity and quality of life in ibd patients deficient in vitamin d, and also help determine the optimal dose of vitamin d3 for them. hypothesis: supplementation of vitamin d3 in ibd patients with hypovitaminosis d can improve their quality of life and decrease ibd activity.

the incidence of hypovitaminosis d has been reported to be as high as 75% in patients with ibd. however, it is unclear whether low vitamin d levels contribute to the pathogenesis of ibd or are a consequence of ibd. recent animal data studies suggest that maintenance of the epithelial barrier integrity in the large intestine by vitamin d is important in preventing ibd. however, more evidence is required to determine the effect of vitamin d3 supplementation in patients with ibd. furthermore, there is no clear consensus regarding the appropriate dose of vitamin d supplementation in ibd patients.

Eligibility criteria:
inclusion criteria: * patients with inflammatory bowel disease (crohn's disease, ulcerative colitis) * 18 years of age or older * 25(oh)d levels \<30ng/ml * willing to give informed written consent exclusion criteria: * age \< 18 years * women who are pregnant or planning to become pregnant * patients already taking vitamin d3 ≥2,000 iu/daily prior to study enrollment
socket preservation technique using bovine bone, platelet rich fibrin or a combination of both: a clinical, radiographic and histological assesment at 4 months

Conditions: Ridge Preservation; Post Extraction Alveolar Bone Resorption

Summary: post extraction alveolar bone resorption is one of the main challenges that face oral implantologists in their daily surgical practice (1). to palliate to post-extraction resorption, advanced bone grafting and regeneration techniques have been described (2). however, these procedures, although well documented and validated, still have relatively high complication rates and patient morbidity, in addition to the elevated cost and duration of treatment (3). socket preservation is a very useful technique in order to counter post extraction resorption issues, therefore eliminating the need for future complicated and delicate regeneration procedures (4). many biomaterials were proposed for socket preservation such as allografts and bovine hydroxyapatite (5). recently autologous platelet concentrates such as platelet rich fibrin prf were described as a potential socket filler material (6). in the proposed protocol, fresh extraction sockets will be either grafted by a bovine bone substitute, a prf plug or a mixture of both. sockets will then be clinically and radiographically monitored over time to assess three-dimensional soft and hard tissue stability. bone quality will be histologically examined at 6 months implant placement. a no graft group will serve as control. the results of this study may be of major importance since they could give an objective idea of the most efficient socket preservation technique, thus offering simple and secure oral rehabilitation solutions for both patient and practitioner.


Eligibility criteria:
inclusion criteria: 1. patients will require single tooth extraction and subsequent implant rehabilitation. 2. patients over 18 years of age. 3. patients willing to comply with the study requirements (signed consent form) 4. good oral hygiene and no signs of active periodontal infection 5. no compromising medical status 6. \< 10 cigarettes smoking per day exclusion criteria: 1. acute myocardial infarction within the last two months; 2. uncontrolled coagulation disorders; 3. uncontrolled diabetes (hba1c\> 7.5); 4. radiation therapy to the head \\ neck region in the last 24 months; 5. immunocompromised patients, hiv positive or receiving chemotherapy in the last five years; 6. past or present treatment with intravenous bisphosphonates; 7. psychological or psychiatric problems; 8. abuse of alcohol or drugs;
observational study on the combination of selinexor with bortezomib and dexamethasone for the treatment of mm patients

Conditions: Multiple Myeloma

Summary: this is an observational study aiming at collecting efficacy and safety data on the use of svd outside clinical trials, for the treatment of adult patients with mm who have received 1-3 prior line of therapy. a minimum of 159 patients is required. overall study duration is estimated in 36 months.

this is a non-interventional, national, multicenter prospective and retrospective observational study aiming at collecting efficacy and safety data on the use of svd outside clinical trials, for the treatment of adult patients with mm who have received 1-3 prior line of therapy. all the sites participating in the study are using svd in clinical practice. according to sample size calculation, a minimum of 159 patients is required. overall study duration is estimated in 36 months: 24 months on enrolment and at least 12 months of observation.

Eligibility criteria:
inclusion criteria: * age equal to or greater than 18 years old at the time of svd initiation * signed informed consent (if applicable). * diagnosis of symptomatic mm, as defined by the international myeloma working group (imwg) criteria. * relapse after one to three lines of therapy. * treatment with svd, (i.e., having already received at least one dose) at the time the combination has entered clinical practice in italy (aifa authorization) * prior treatment with and refractoriness to lenalidomide. exclusion criteria: - previous exposure to selinexor.

Keywords: selinexor bortezomib dexamethasone
evaluation of the cost-effectiveness and sensitivity of automatic analysis versus manual analysis of polygraphy in the diagnosis of obstructive sleep apnea.

Conditions: Obstructive Sleep Apnea

Summary: obstructive sleep apnea (osa) is a chronic pathology that affects more than 20% of the adult population. it is one of the main sleep disorders with great clinical, economic and social repercussions. to assess the impact and severity of obstructive sleep apnea, the number of apneas and hypopneas per hour (ahi) is counted. to define that a person has oas, a sleep study must have an ahi ≥15/h, predominantly obstructive, or the presence of an ahi ≥5/h accompanied by symptoms. the diagnosis of certainty or exclusion, as well as the severity, is established with a sleep study. polysomnography (psg) continues to be the gold standard for the diagnosis of osa, it encompasses the recording of cardiorespiratory and neurophysiological variables, which makes it possible to analyze sleep time and structure, the presence of different respiratory episodes and their repercussions. respiratory polygraphy (rp) includes recording from a flow sensor, respiratory effort, oxygen saturation, heart rate, and also position but not eeg. there are several studies that have explored the diagnostic agreement of rp versus psg, being a validated, useful and necessary test for the diagnosis of osa in different clinical situations. being cheaper and more accessible. when talking about the diagnosis of osa, it refers to establishing whether or not there is, the severity and the therapeutic decision that will greatly affect the quality of life, prognosis and day-to-day life of the patient, since it is a chronic disease. it must be borne in mind that most studies are carried out in a field specialized in dream interpretation, so caution must be exercised in interpreting results in another field. pr teams incorporate increasingly better developed software that allows automatic analysis of records, but the technology and algorithms used vary depending on the device, and up to now the aasm continues to recommend manual analysis based on existing evidence. several studies have examined the agreement between automatic and manual analysis of the pr record or between automatic analysis of pr and psg. it seems that this agreement is reached above all in the highest ahis, above 25-30, which may limit its use in clinical practice. for this reason, it is important to carry out a study with a large number of patients to achieve statistical significance, and strong conclusions that support normal clinical practice, and to disable a study that does not meet the scientific requirements when interpreting and reading.


Eligibility criteria:
inclusion criteria: * respiratory polygraphs carried out at the san pedro hospital in the period of time between 2014-2020. * polygraphs corresponding to patients over 18 years of age. exclusion criteria: * poor technical quality of polygraphy * patients with \>50% central apnea or presence of cheyne-stokes respiration (csresp). * lack of automatic and/or manual analysis of the polygraph.
covid safe: covid-19 screening assessment for exposure

Conditions: Covid19

Summary: in order to safely and effectively reopen businesses and universities across the us, institutions will need to develop approaches to rapidly identify covid-19 cases and manage their spread while balancing program effectiveness, feasibility, costs, and scalability. this study will evaluate the implementation of a covid-19 screening program that coordinates several existing systems at the university of pennsylvania including saliva-based viral testing.

the coronavirus disease 2019 (covid-19) pandemic has resulted in close to 10,000,000 reported cases worldwide, including more than 2,000,000 aggregated reported cases and 120,000 deaths in the united states. initial efforts to address the covid-19 pandemic were aimed at testing symptomatic individuals, implementing stay-in-place orders, and at increasing hospital capacity to meet surge demands. while nations continue to confront the current crisis, plans for the future must be put in place tools to enhance our ability to conduct effective screening, containment, and case management. widespread covid-19 testing is needed to safely and effectively reopen schools and businesses across the us. however, currently approved testing options require reagents that are limited in supply, severely hindering scalability. emerging evidence indicates that saliva testing with the option of at-home sample collection can accurately identify covid-19 viral infection. additional diagnostic testing options will continue to increase patient access. moreover, this approach provides an option for the easy, safe and convenient collection of samples required for testing without traveling to a doctor's office, hospital, or testing site. collection by the patient also reduces exposure of health care workers to the virus and preserves limited personal protective equipment. with access to expanded testing, health systems and universities will need to test alternative methods to manage covid-19 spread while balancing program effectiveness, feasibility, costs, and scalability. insights from the field of behavioral economics offer promise for designing and sustaining these kinds of policies. for these reasons, the investigators propose to evaluate the implementation of a covid-19 screening program that uses saliva-based testing.

Eligibility criteria:
inclusion criteria: * be 18 years or older * university of pennsylvania faculty, staff, or trainee * have a phone or device capable of receiving text messages * willing to participate in the study for 6 months exclusion criteria: * participants will not be eligible if they identify any reason they are unable to participate in the study.

Keywords: covid-19 coronavirus
safety and tolerability of m254 in healthy volunteers and immune thrombocytopenic purpura (itp) patients

Conditions: Immune Thrombocytopenic Purpura (ITP)

Summary: the purpose of this study is to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of m254 after administration of a single ascending dose and repeat doses in healthy volunteers and immune thrombocytopenic purpura (itp) patients. the pharmacodynamics of the drug will be measured as platelet response in patients with itp.

the part a of the study is currently not accepting healthy volunteers as the recruitment for the part a has completed.

Eligibility criteria:
key criteria for healthy volunteers: subject must be between the ages of 18 and 55 years; healthy as indicated by medical history, physical examination, vital signs, clinical laboratory tests, and 12-lead electrocardiogram, and all abnormal findings are assessed as not clinically significant by the investigator; not pregnant or breastfeeding; and no other clinically relevant abnormalities currently or in their history that the investigator would deem them ineligible to participate. key criteria for immune thrombocytopenic purpura (itp) patients: patient must be aged ≥18 years and diagnosed with itp at least 3 months prior to screening, stable maintenance therapy for at least 4 weeks prior to the first study visit, not pregnant or breastfeeding, and no other clinically relevant abnormalities currently or in their history that the investigator would deem them ineligible to participate.

Keywords: immune thrombocytopenic purpura healthy subjects m254 intravenous immunoglobulin (ivig)
vibrotactile coordinated reset for the treatment of chronic stroke

Conditions: Chronic Stroke

Summary: the purpose of our study is to evaluate vibrotactile coordinated reset stimulation (vcr) and its effects on motor ability within stroke patients. vcr will be administered with a device called the vibrotactile (vt) brain glove. vcr is expected to provide patients with a non-invasive therapy to aid in recovery from a stroke. this study will include a dedicated sham arm that will aid in understanding true treatment effects from vcr.


Eligibility criteria:
inclusion criteria: 1. age at the time of enrollment: 18-80 years 2. diagnosis of ischemic or hemorrhagic stroke 3. disease period of more than 6 months 4. mini mental state examination of at least 24 points 5. no medications that affect balance 6. motor deficit 7. use of motricity arm and leg index to include impaired individuals with some functioning 8. modified rankin scale for neurologic disability: scores 3 or 4 exclusion criteria: 1. any significant psychiatric problems, including acute confusional state (delirium), ongoing psychosis, or clinically significant depression 2. any current drug or alcohol abuse 3. history of recurrent or unprovoked seizures 4. any neurological disorder treatments that involve intracranial surgery or device implantation 5. participation in another drug, device or biologic trial concurrently or within the preceding days 6. pregnancy, breastfeeding or wanting to become pregnant during the trial 7. history or presence of other major neurological or orthopedic diseases other than stroke that limits motor functioning or cognitive ability 8. more than 5 degrees of contracture at shoulder, elbow, wrist, finger, hip, knee, or ankle 9. botox, baclofen or any other treatment for spasticity except for bracing or splinting within the previous 3 months 10. must be able to communicate with staff 11. severe sensory abnormalities of the fingers such as vibratory urticaria
pet/ct-directed hyperfractionated radiation dose escalation in stage iii non-small cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: the goal of this study is to find the maximum tolerable dose of radiation that can be delivered combined with chemotherapy (carboplatin \& paclitaxel) in patients with stage iii non-small cell lung cancer (nsclc).

concurrent chemoradiotherapy is the standard of care for unresectable stage iii nsclc based on the results of phase iii randomised trials. the current standard radiation therapy dose has remained 60- gy at -2 gy/fraction for nearly four decades (60gy), with local disease control rates of approximately 50% and a median overall survival of only 18 months.these results are suboptimal and more effective treatment regimens are needed. we hypothesize that hyperfractionated radiation dose escalation to residual tumor volumes after standard chemoradiotherapy as defined by positron emission tomography (pet) /computed tomography (ct) would improve local control and overall survival while reducing the acute and late normal tissue toxicity.

Eligibility criteria:
inclusion criteria: 1. patients must have fdg-avid and histologically or cytologically proven non-small cell lung cancer. 2. age 1 8-75. 3. zubrod performance status 0-2. 4. stage iii ( american joint committee on cancer ajcc, 7th ed.). 5. no prior radiation to the thorax that would overlap with the current treatment field. 6. adequate bone marrow, renal and hepatic functions as assessed by the following: hemoglobin \>/= 10.0 g/dl, platelet count \>/= 1 00,000/mm\^3,absolute granulocyte count (agc) ≥2 × 10\^9 cells/l,bilirubin and aspartate transaminase ≤1.5 ×upper limit of normal (uln), creatinine \</=1 .5 times uln. 7. a signed informed consent must be obtained prior to therapy. 8. induction chemotherapy is allowed. 9. life expectancy more than 3 months. exclusion criteria: 1. patients with any component of small cell lung carcinoma are excluded from this study. 2. patients with evidence of a malignant pleural or pericardial effusion are excluded. 3. prior radiotherapy that would overlap the radiation fields. 4. uncontrolled concurrent illness including, but not limited to: chronic obstructive pulmonary disease(copd) exacerbation or other respiratory illness, serious uncontrolled infection, symptomatic congestive heart failure (chf),unstable angina pectoris, uncontrolled hypertension,or psychiatric illness/social situations that would limit compliance with the study requirements. 5. known hypersensitivity to paclitaxel. 6. any other condition or circumstance that would, in the opinion of the investigator, make the patient unsuitable for participation in the study. 7. acquired immune deficiency syndrome. 8. conditions precluding medical follow-up and protocol compliance.
surgical extrusion for the clinical crown lengthening: a 12-months clinical study

Conditions: Tooth Decay

Summary: this is a prospective study in which surgical extrusion of single-rooted teeth is carried out by the same operator in 15 consecutive patients. main objective: to evaluate the soft tissue rebound of the teeth 1 year after the surgery. null hypothesis (h0): surgical extrusion is not a predictable treatment for the restoration of single rooted teeth.


Eligibility criteria:
inclusion criteria: * systemically and periodontally healthy, non-smoking patients. * single-rooted, straight teeth with insufficient ferrule, which require restorative treatment. * teeth with a favorable crown-root ratio. exclusion criteria: * severe systemic disease patients (american society of anesthesiologists classification 1 or 2). * multi-rooted, curved and/or short teeth. * teeth with an uncontrolled periodontal pathology. * pregnant women. * teeth with types ll or lll mobility.

Keywords: extrusion