Kornimate/medical-research-clean huggingface dataset:
a phase 4 study to evaluate response to treatment and safety of paliperidone extended-release in participants with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to evaluate the response to treatment and safety of paliperidone extended-release (mechanism to dissolve a drug over time in order to be released slower and steadier into the blood stream) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

this is a non-randomized, single-arm, multi-center (conducted in more than one center) study to explore response to treatment and safety of flexible dose of paliperidone extended-release (er) in participants with schizophrenia. during the study period, dose of paliperidone er will remain within the range of 3 to 12 milligram per day and will be administered for 12 months. both hospitalized and non-hospitalized participants may be included in the study. participants may switch to any effective dose of paliperidone er from any oral antipsychotic medication without dose adjustment or if required, cross-dose adjustment may be done. maximum 4 weeks of switching period is allowed. use of anticholinergic (opposing the actions of the acetylcholine, a neurotransmitter) drugs will not be restricted. response to treatment will be evaluated primarily through total personal and social performance (psp) scale. participants' safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * schizophrenia diagnosis according to diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) * recent onset (less than 3 years after the first episode/hospitalization) schizophrenia but either not on antipsychotic medication for at least 3 months or in need of antipsychotic medication switches because of safety and/or lack of efficacy reasons * to be considered physically healthy at screening according to vital signs and physical examination findings. if there are abnormalities, they must be consistent with the underlying illness in the study population * women at postmenopausal state for at least 1 year; or undergone surgical sterilization, or for women with child-bearing status, should be willing to use an effective contraceptive method throughout the study * participants who are willing and capable to complete the questionnaires exclusion criteria: * use of clozapine, depot neuroleptics or risperidone within the last 3 months * any unstable clinical condition including clinically important abnormal laboratory findings * previous and current tardive dyskinesia (abnormal involuntary movements which primarily affect the extremities, trunk, or jaw) symptoms * history of malignant neuroleptic syndrome * to be considered carrying high risk regarding adverse effects, homicide and/or suicide

Keywords: schizophrenia paliperidone invega
a trial of the efficacy and safety of sep-363856 in acutely psychotic participants with schizophrenia

Conditions: Schizophrenia

Summary: this is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to determine the the efficacy and safety of sep-363856 in acutely psychotic participants with schizophrenia


Eligibility criteria:
key inclusion criteria: * male or female participants between 18 to 65 years of age (inclusive) at the time of consent. * participant has an identified reliable informant (eg, caregiver, relative, friend, case worker, residential treatment staff). * participant is experiencing an acute exacerbation or relapse of symptoms, with onset ≤ 2 months prior to screening 1. the participant requires hospitalization for this acute exacerbation or relapse of symptoms. 2. if already an inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation at the time of screening. * participants who are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by meeting all of the following criteria at the screening and baseline visits: 1. participant must have a panss total score ≥ 80 and 2. participant must have a cgi-s score ≥ 4. * participants who have received previous outpatient antipsychotic treatment at an adequate dose (minimal recommended dose for the treatment of schizophrenia according to the manufacturer labeling) for an adequate duration (at least 6 weeks) and who showed a previous good response. key exclusion criteria: * sexually active participants or persons of childbearing potential who do not agree to practice 2 different clinical trial sponsor approved methods of birth control or remain abstinent during the course of the trial and for 30 days after the last dose of study drug. * participant has a current dsm-5 diagnosis or presence of symptoms consistent with a dsm-5 diagnosis other than schizophrenia. * participant has had psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days prior to screening. * participant has previously received sep-363856 or was previously enrolled in a sep-363856 clinical study
amino acid usage patterns in daily practice

Conditions: Wounds; Lean Body Mass

Summary: the present study aims to evaluate the patient profile including medical conditions who use a nutritional supplement along with a balanced and varied diet in turkey.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old. * consuming amino acid containing oral nutritional supplement before enrolment for malnutrition for hard-to-heal wounds or malnutrition due to primary disease. * followed by internal medicine or surgery departments. exclusion criteria: * history of allergy or hypersensitive reaction to any ingredient in the amino acid containing oral nutritional supplement. * history of any food allergy or intolerance
clinical comparative study of personalized shoulder, knee and ankle brace

Conditions: Shoulder Injuries; Knee Injuries; Ankle Injuries

Summary: this study is based on human anatomical data and uses computer-aided engineering (cae) software such as biomedical image processing software, reverse engineering software, cad software, and finite element analysis software to create a three-dimensional bracing model. with the help of 3d printing technology, we have developed personalized brace, completed the personalized rapid design and optimization of the three series of support equipment products such as the posterior cruciate ligament brace, ankle ankle brace, and shoulder brace.

the traditional brace mainly includes small splints or gypsums. the manufacturing process is rough, and the flexibility is poor. in recent years, with the development of orthopedic surgery, rehabilitation concept, modern polymer materials, and biomechanics, great progress has been made in r\&d, production, and assembly of orthoses. in developed countries, orthoses is not only widely used after orthopedic surgery and the department of rehabilitation, but it has become the main auxiliary device for sports trauma surgery, immobilization, treatment, and rehabilitation training. leading bracing company such as djo has developed multi-brand correction devices such as aircast®, chattanooga, cmf, compex®, donjoy®, empi® and procare®. however, these braces are not designed and manufactured based on patients. individually designed products for anatomical structures still have many problems in clinical applications.

Eligibility criteria:
inclusion criteria: * patients accepting arthroscopic surgery of the shoulder, posterior cruciate ligament reconstruction surgery, achilles tendon rupture repair surgery. exclusion criteria: * severe peripheral ligament injury of should, knee and ankle.

Keywords: personalized brace shoulder knee ankle
clinical and laboratory assessments of effectiveness of silver diamine fluoride (sdf) in arresting caries among children and parental ￼satisfaction

Conditions: Caries Arrested

Summary: globally, it is estimated that 2.4 billion people suffer from caries of permanent teeth and 486 million children suffer from caries of primary teeth . the highest estimate of dental caries prevalence in saudi arabia was 95% with maximum dmft of 7.34 among 3-7 years old children . also, it was found that 78% of 6-9 years old children in dammam had caries with an average of 3.66±3.13 dmft. the objectives of this study are: 1. to assess the effectiveness of the silver diamine fluoride (sdf) in arresting caries. 2. to assess the antibacterial effect of the silver diamine fluoride (sdf). 3. to assess parents' and children's satisfaction and acceptance. the aims of our study are to assess the effectiveness of sdf in arresting caries in primary dentition among children visiting imam abdulrahman bin faisal university in dammam, saudi arabia and to assess parental acceptance and satisfaction. the expected outcome the results of this study will help in understanding the effectiveness sdf in arresting dental caries in this target population especially that it was recently approved for clinical use in saudi arabia.


Eligibility criteria:
inclusion criteria: * children between four and six years of age. * healthy. * have at least two active dentin carious lesions on the primary teeth meeting the international caries detection and assessment system (icdas) score 5 or 6. * should not have periapical infection, root resorption or widening in the periodontal ligament space. exclusion criteria: * participants who have systemic or neurological diseases. * tooth abscess, pain on percussion, symptoms of pulpal involvement or mobility, * allergic to silver or any dental material to be used. * unable to attend follow-up visits.
post-acute multicomponent frailty intervention

Conditions: Frailty

Summary: the goal is to test feasibility of a frailty intervention, including exercises and nutritional supplementation.

the frailty intervention includes frequent short exercise sessions incorporating balance, resistance training, and walking to accommodate diminished endurance, with synergistic protein and nutritional supplementation, delivered on top of usual care in the post-acute skilled nursing facility (snf) setting. there is no control group.

Eligibility criteria:
inclusion criteria: * community-dwelling before hospitalization * age ≥ 65 years * admitted to snf directly from inpatient hospitalization * english speaking * mild frailty or worse, as measured by a clinical frailty scale exclusion criteria: * discharged from emergency department * non-community discharge plan on admission (e.g. plan to discharge to hospice) * nothing per oral (npo) dietary status * presence of any feeding tube * chronic kidney disease stage iv or worse * clinician refusal * inability or refusal to consume intervention products (e.g. allergies to protein supplement) * inability to consent to study procedures
high-dose cytarabine/mitoxantrone followed by autotransplantation for t-mds/t-aml

Conditions: Myelodysplastic Syndrome; Acute Myeloid Leukemia

Summary: the purpose of this study is to determine the effectiveness of a particular combination of drugs used to treat cancer.


Eligibility criteria:
inclusion criteria: * patients must have received cytotoxic chemotherapy,radiation,or a drug known to affect the properties of dna or cell growth for some condition other than acute myeloid leukemia prior to diagnosis. * patients must have t-mds/t-aml * to be eligible for allogeneic transplantation, patients must have a suitable donor who is hla compatible. * patients must be over the age of 10. * patients must be reviewed and discussed at the leukemia and transplant conferences of the section of hematology/oncology. exclusion criteria: * patients must not have any other serious medical condition(e.g.uncontrolled or severe cardiovascular disease, diabetes, pulmonary disease, or infection) * psychiatric condition which would prevent compliance or possibly be worsened by treatment

Keywords: therapy-related myelodysplastic syndrome/ therapy -related acute myeloid leukemia myelodysplastic syndrome acute myeloid leukemia
dna methylation profile of the socs-1 gene promoter in smokers patients with chronic periodontitis.

Conditions: Periodontal Diseases; Epigenetics

Summary: periodontitis is related to host genetics, constitution of the dental biofilm and environmental factors such as smoking. dna methylation is a mechanism of genetic expression that can inhibit or silence gene expression. in this way several researchers have been dedicated to study the genetic influence on the susceptibility and / or increased risk to periodontal disease. studies have reported association between several epigenetic biomarkers with periodontal inflammation. considering the hypothesis that there is an association between smoking and methylation in genes related to periodontal disease, the objective of this study was to verify the dna methylation pattern in oral epithelial cells of patients with chronic periodontitis (cp) in the promoter of a specific gene involved in the control of inflammation, as suppressor of cytokine signaling (socs) 1 in smokers and nonsmokers patients.

this was an experimental type study with parallel controls, comparing two groups, a group with consumption of 10 minimum cigarettes per day, with a diagnosis of chronic periodontitis. and another control group were non-smokers with chronic periodontitis. for this, genomic dna was purified from oral epithelial cells obtained by rinsing with 3% sucrose, for a single time of collection, patients received periodontal treatment after collection and data analysis. the dna was modified by sodium bisulfite and the methylation patterns of the dna were analyzed with the mspcr technique (polymerase chain reaction). this study was approved by the institutional review board of the school of dentistry of ribeirão preto (caae:57171816.2.0000.5419 ), and all patients need to provide written informed consent.

Eligibility criteria:
inclusion criteria: * chronic periodontitis carriers - presence of proximal insertion loss ≥5 mm in more than 30% of the teeth present. * periodontal pocket ≥ 5mm * smokers who have smoked 10 or more cigarettes per day for the past five years. * no positive history of basic periodontal treatment in the last six months. exclusion criteria: * extensive prosthetic involvement. * using anti-inflammatories. * pregnant or nursing. * presence of systemic alterations that compromise host response or require prophylactic medication for treatment. * history of constant use of oral antiseptics in the last six months.

Keywords: dna methylation. smoking. socs-1 gene.
proton stereotactic body radiation therapy for early-stage non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: stereotactic body radiation therapy (sbrt) is a special form of treatment which pinpoints high doses of radiation directly to cancer. standard radiation (or photon radiation) is commonly used for sbrt to treat non-small cell lung cancer (nsclc). proton beam radiation is a special type of radiation only available at a few institutions in the us and has not been previously used in sbrt to treat nsclc. the use of protons for sbrt may improve the accuracy of the treatment and may help to minimize the dose delivered unnecessarily to healthy tissue. in this study, the investigators are evaluating the safety and effectiveness of proton-based sbrt for early-stage nsclc located in the periphery of the lung.

subjects will undergo an electronic navigational bronchoscopy (enb) during which three markers will be placed around their tumor which will guide the delivery of proton beam radiation to their with more precision and accuracy. subjects will receive a ct scan to obtain images to plan radiation treatment. proton radiation will be delivered daily (4 or 5 consecutive days) on an outpatient basis at massachusetts general hospital. after the final dose of proton radiation subjects will be followed for 5 years. subjects will be asked to return at 3 months, and then every 3 months until 2 years, and then every 6 months until 5 years. subjects will receive a chest ct, tumor assessment by ct or pet, chest x-ray, pulmonary function tests and a physical exam.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed non-small cell lung cancer (need not be newly diagnosed) * stage clinical t1 n0 m0 or t2 n0 m0 * nsclc must be limited to a single lesion * nsclc must be peripherally located (\> 2 cm from proximal bronchial tree and \> 1 cm from mediastinal pleura) * nsclc must be considered medically inoperable * life expectancy greater than 6 months exclusion criteria: * pregnant or breastfeeding * prior radiation therapy to the lungs or mediastinum * prior malignancy in the last 2 years unless treated definitively and disease free or carcinoma in situ or early stage skin cancers that have been definitively treated * receiving other study agents or other types of cancer therapy * uncontrolled intercurrent illness * pacemaker or defibrillator-dependent

Keywords: nsclc lung cancer
role of cerebral oximetry in reducing delirium after complex cardiac surgery

Conditions: Cardiac Disease

Summary: delirium after cardiac surgery is reported in a range of 3-47% of patients. delirium is a serious complication that results in prolonged length of stay, increased health care costs and is associated with higher death rates. the exact cause involved in the development of delirium after cardiac surgery is unclear. the latest advancement in near-infrared spectroscopy (nirs) oximetry offers real-time management of patients at risk of brain injury. this approved device will monitor cerebral oxygenation during and 24hr after cardiac surgery, recording oxygenation in real time allowing the clinical team the opportunity to intervene early to prevent ischemia and possibly preventing untoward events. adverse events followed include, but are not limited to, stroke, (transient ischemic attacks), heart attack, (myocardial infarction), clots found in lungs (pulmonary embolism), kidney failure, pneumonia, cause of death for 30-days after surgery (all cause mortality). hypothesis: perioperative restoration of rso2 desaturation to baseline values results in lower delirium rates after complex cardiac surgery.


Eligibility criteria:
inclusion criteria: * age \> 60 years * combined valve and cabg * repeat cardiac surgery * multiple valve replacement or repair * surgery of ascending aorta and aortic arch * signed informed consent. exclusion criteria: * cardiac surgery without the use of cardiopulmonary bypass * symptomatic cerebrovascular disease, * history of delirium, or * schizophrenia

Keywords: cardiac surgery delirium cerebral oximetry
calcium sulfate spacer in open tibia fractures

Conditions: Open tíbia Fracture With Sub-segmental Bone Loss

Summary: investigators will compare antibiotic impregnated calcium sulfate versus pmma versus nothing in these sub-segmental bone defects.


Eligibility criteria:
inclusion criteria: * open tibia shaft fracture treated with an imn exclusion criteria: * none
lidocaine infusion on hysteroscopic media versus oral diclofinac for pain relief during outpatient hysteroscopy

Conditions: Nulliparity

Summary: lidocaine infusion on hysteroscopic media versus oral diclofinac for pain relief during outpatient hysteroscopy. a randomized controlled trial.

10 ml of 2% lidocaine hydrochloride added on saline infusion media versus 100 mg diclofenac tablet 1 hour before office hysteroscopy , to test their efficacy in reducing pain .

Eligibility criteria:
inclusion criteria: * age: 18-35 years. * bmi 18.5-30 kg. * nulliparous women assigned for diagnostic hysteroscopy. * informed written consent. exclusion criteria: * previous cervical surgery. * cervical stenosis. * known gastritis. * recent or active pid. * cardiac patients.
intermediate-size patient population expanded access program for intravenous difelikefalin

Conditions: Uremic Pruritus

Summary: this is an intermediate-size patient population expanded access protocol for the use of intravenous (iv) difelikefalin for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients undergoing hemodialysis.

visits during the expanded access program will consist of a baseline visit to confirm eligibility and an end of treatment visit. patients will receive iv difelikefalin at a dose of 0.5 mcg/kg after each dialysis session, generally 3 times per week. the end of treatment visit will be defined as the first dialysis visit following the last dose of iv difelikefalin under the intermediate-size patient population expanded access protocol.

Eligibility criteria:
key inclusion criteria: * adults ≥ 18 years old; * has end-stage renal disease (esrd) and is currently receiving in-center hemodialysis; * has moderate-to-severe pruritus attributed to esrd which is significantly impacting the patient's quality of life; * has no comparable or satisfactory alternative therapy for the treatment of moderate-to-severe pruritus, as determined by the sponsor-investigator. key exclusion criteria: * has severe hepatic impairment (child-pugh class c), as the influence of severe hepatic impairment on the pharmacokinetics of difelikefalin has not been evaluated; * is pregnant or nursing; * has been exposed to any other investigational medication in the past 60 days; * present any other reason which may lead to an unfavorable risk-benefit ratio for treatment with difelikefalin, as determined by the sponsor-investigator; * has a known or suspected allergy to difelikefalin or any component of the investigational product.

Keywords: hemodialysis pruritus uremic pruritus dialysis cr845 difelikefalin chronic itch ckd ckd-associated pruritus ckd-ap esrd (end stage renal disease) itch itching kalm chronic kidney disease kidney failure, chronic kidney dysfunction generalized pruritus expanded access compassionate use