Kornimate/medical-research-clean huggingface dataset:
predicting outcomes in hypoglossal nerve stimulation therapy with stimulated upper airway mechanics

Conditions: Sleep Apnea, Obstructive

Summary: obstructive sleep apnea (osa) is a highly prevalent disease resulting from dynamic upper airway collapse during sleep. continuous positive airway pressure (cpap) is highly efficacious but high rates of non-adherence to cpap leaves large number of osa patients at risk for cardiometabolic sequelae. inspire™ is an fda-approved hypoglossal nerve stimulation device (hgns) used in select patients with osa who are intolerant of cpap. the device consists of an implanted impulse generator with a stimulating cuff lead around the distal hypoglossal nerve. despite these stringent selection criteria, up to one-third of patients implanted have inadequate responses to hgns and remain at risk for complications from untreated osa. the current proposal builds on routine clinical care to characterize upper airway biomechanics and determine predictors of clinical responses to hgns therapy. drug induced sleep endoscopy (dise) is a prerequisite for hgns treatment and represents an ideal opportunity to rapidly characterize upper airway dynamics under controlled, standardized conditions. the amount of nasal pressure required to relieve airway obstruction (minimal therapeutic pressure) is a significant predictor of successful treatment of osa with hgns. as a result, cpap titration (measuring pharyngeal collapse patterns at varying nasal pressures) has become an integral part of dise to select parties for hgns at multiple institutions. nevertheless, changes in upper airway collapsibility in response hgns may differ significantly between patients. this stud will examine if changes in upper airway patency with direct genioglossus muscle stimulation at the time of dise predicts successful treatment with hgns as defined by a 50% reduction on apnea-hypopnea index (ahi) and an on-treatment ahi \<20.


Eligibility criteria:
inclusion criteria: * male and female participants with moderate or severe sleep apnea (defined by \> 15 apneas and hypopneas per hour of sleep), who are undergoing dise as part of routine evaluation for inspire hypoglossal nerve stimulation therapy or for ineffective hgns therapy. exclusion criteria: * significant cardiac disease, unstable or recent cardiac events * active pulmonary, liver or renal disease * uncontrolled hypertension (bp\>160/100) * neuromuscular disease * major psychiatric disease * pregnancy * anticoagulation therapy (e.g. coumadin, dabigatran)
augmented reality exposure therapy for cynophobia

Conditions: Phobia Animal

Summary: the feasibility study for the augmented reality exposure therapy for cynophobia will be carried out for people with dog phobia. this feasibility study's sample will be adults living in turkey. the informed consent form and demographic form will be sent to the participants who have given this approval. those who are eligible will be invited to diagnostic interviews. those participants who meet the inclusion criteria will be included in the feasibility study. 22 participants are expected to participate in this study. the phobia severity will be measured three times: once before and twice after the intervention.

specific phobia is an overwhelming fear of an object, place, situation, feeling or animal. for the treatment of specific phobias, exposure therapy is accepted as the most effective way to treat the patients and it is frequently used by psychiatrists and psychotherapists. to treat specific phobias using exposure therapy, the patients are exposed to their feared objects or situations in a safe and controlled environment while they are guided and accompanied by a therapist. it is not always possible to conduct in vivo treatment however, due to a number of reasons such as the feared objects being unavailable, cost-effectiveness, patients with extremely high anxiety etc. results of the former studies revealed that specific phobias can be treated using augmented reality (ar) where patients are exposed to virtually created feared objects in real life context. there are limited studies that have been conducted to test the effectiveness of ar because it is a newly developed technology. former studies used ar to treat phobia of smaller object such as fear of cockroaches, insects and spiders. the current study aims to test whether ar is a successful tool that can be utilized as a treatment option for people with specific disorders. more specifically, we aim to test the effectiveness of augmented reality exposure therapy (aret) in the treatment of patients with cynophobia, i.e., fear of dogs.

Eligibility criteria:
inclusion criteria: * clinician-confirmed dog phobia * scoring 10 or higher on the specific phobia scale (adult version) exclusion criteria: * psychosis and/or substance use disorder * epileptic seizure history * uncorrected visual impairment
a trial comparing docetaxel plus fulvestrant with docetaxel in metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: comparing docetaxel plus fulvestrant with docetaxel in patients with metastatic breast cancer

comparing docetaxel plus fulvestrant with docetaxel in postmenopausal, hormone-receptor positive and her2-negative metastatic breast cancer

Eligibility criteria:
inclusion criteria: * postmenopausal female between 18 and 70 years old * ecog performance status of ≤ 1 * life expectancy more than 3 months * histologically confirmed metastatic breast cancer * er and\&or pr pqositive, her2-negative * disease progression during adjuvant or first-line endocrine therapy, or endocrine naive but unsuitable for endocrine therapy alone * no pretreated chemotherapy for metastatic disease * have at least one target lesion according to recist 1.1 * no therapy (chemotherapy, endocrine therapy, target therapy and operation) within 4 weeks before enrollment * hemoglobin ≥ 90 g/l, absolute neutrophil count ≥ 1.5×10\^9/l, platelet count ≥ 75×10\^9/l, serum bilirubin ≤ 1.5×uln, alt and ast ≤ 1.5×uln, serum creatinine ≤ 1×uln, endogenous creatinine clearance\>50ml/min exclusion criteria: * pregnant or lactating women * evidence of cns metastasis * seriously uncontrolled infection * history of another malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * pretreated with fulvestrant * pretreated with two or more lines of endocrine therapy

Keywords: chemotherapy endocrine therapy docetaxel fulvestrant
study of a3309 in patients with dyslipidemia

Conditions: Dyslipidemia

Summary: the purpose of this trial is to determine the efficacy and safety of a3309 administered to patients with dyslipidemia (high cholesterol levels).


Eligibility criteria:
inclusion criteria: * patients meet protocol specified criteria for dyslipidemia and has successfully completed study requirements with no clinically relevant findings exclusion criteria: * medical history or medical condition that would not make the patient a good candidate for the study or would limit the patient´s capability to complete the study

Keywords: dyslipidemia cholesterol ldl
the effect of dry needling on muscle stiffness, gait, motion, and strength in healthy individuals with trigger points

Conditions: Trigger Point Pain, Myofascial

Summary: this study would be the first study to assess the immediate effects of dry needling of latent trigger points of the gastrocnemius muscle on muscle stiffness, gait, range of motion, and strength. the study has the potential to demonstrate that dry needling may have immediate effects on mechanical properties of muscle and may thus guide future treatment for individuals with changes in muscle tissue secondary to pain and/or injury.

participants will complete the following tests: muscle stiffness testing in both a relaxed and contracted position, gaitrite for spatial and temporal gait characteristics, the ankle lunge test (alt) to assess range of motion, and calf strength using a dynamometer. subjects will then receive treatment according to which group they are randomized. muscle stiffness, gait, motion and strength will be reassessed immediately following treatment at the first session. four to10 days later, participants will complete the same tests and measures prior to treatment being administered a second time. another 4-10 days after the second session, participants will complete the tests and measures one final time.

Eligibility criteria:
inclusion criteria: 1. age 18-50 years 2. able to read and speak sufficient english to complete consent form 3. symmetrical gait pattern demonstrated through observation 4. presence of latent trigger point in gastrocnemius muscle exclusion criteria: 1. any prior foot/ankle surgery, deformity, or injury on the which would affect strength of the gastrocnemius 2. any prior acupuncture or dry needling within the past month 3. history of systemic disorder in which dry needling would be contraindicated (i.e. bleeding disorders or anticoagulant medication use) 4. have fractures of the spine, hip, or knee that would likely affect their weight bearing or gait 5. restrictions in plantar flexion range of motion which would inhibit performing a heel raise 6. no specific calf injury in the past 6 months 7. participants known or thought to be pregnant
prehab prior to undergoing tricuspid intervention

Conditions: Tricuspid Valve Disease; Tricuspid Regurgitation

Summary: this study will aim to standardize the prehabilitation protocol to optimize patients and document the clinical and echo variables that could improve clinical outcomes of tricuspid valve intervention.

prior to screening activities, each subject will be given an opportunity to ask questions and to understand the details of study participation. subjects who meet the inclusion and exclusion criteria and have signed an informed consent form will be considered enrolled into the study. after a subject is consented and enrolled in the study, data will be collected prior to any intervention or surgery at the following time points: a) screening/baseline b) day 1 of prehab c) day 2 of prehab d) day 3 of prehab e) day 4 of prehab, f) and any data collected immediately prior to an intervention or incision (in the case of a surgical patient) subjects meeting eligibility criteria with planned tricuspid intervention will receive in-hospital optimization with thhbp's prehab protocol. prehabilitation will consist of careful pre-intervention assessment and personalized optimization, guided by investigator judgment, with a specific focus on right ventricular function. this will be done by using a detailed echo acquisition protocol (appendix 1). assessments will be collected according to the schedule of events below (table 1.). therapy will include intravenous milrinone therapy and aggressive diuresis with evaluation for clinical and functional signs of improvement, according to standard of care. if there are clinical and functional signs of improvement before day 4, and the subject is ready for tv surgery or any other intervention, they will have day 4 procedures performed. after the tests and evaluations are completed, the principal investigator or sub-investigators will decide if the patient is a candidate for tv surgery or another intervention

Eligibility criteria:
inclusion criteria: 1. ≥ 18 years of age 2. moderate-severe or severe tr 3. undergoing tricuspid valve surgical or catheter-based intervention exclusion criteria: 1. clinical instability according to the judgement of the investigator
a 6 week pharmacokinetics, pharmacodynamics, safety and tolerability of gk1-399 in type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this trial is to study the drug levels and biomarkers in the body and the safety of an investigational drug (gk1-399) in patients with type 2 diabetes. patients in the study will receive placebo for 1 week followed by 1 of 4 treatments for 6 weeks. one of the 4 treatments will be placebo, which does not contain an active ingredient. the study participation includes in-patient and out-patient days.


Eligibility criteria:
inclusion criteria: * be male or female, aged 18 through 75 years at screening. * have a diagnosis of type 2 diabetes mellitus (t2dm) * on a stable dose of background medication for the treatment of diabetes * body mass index (bmi) between 20-40 kg/m2 (inclusive) exclusion criteria: * subjects with type 1 diabetes, heart attack or stroke in the past 6 months, uncontrolled blood pressure, significant kidney disease

Keywords: type 2 diabetes mellitus pharmacokinetics pharmacodynamics
transition of single surgeon bariatric service to an interdisciplinary multiple surgeon model

Conditions: Obesity; Bariatric Surgery Candidate

Summary: this retrospective study will analyse the transition of an australian hospital which significantly increased volume of bariatric operations after introduction of a clinical pathway, and to assess the outcomes. barriers to introduction of the multidisciplinary pathway and the means to overcome these will also be analysed and discussed. the analysis will also determine if there are any other areas of bariatric surgery which can be further investigated to optimise current practice.


Eligibility criteria:
inclusion criteria: * participants must have had bariatric surgery at the queen elizabeth hospital between 2008-2018 exclusion criteria: * nil
complementary/alternative medicine for abnormality in the vestibular (balance) system

Conditions: Vestibular Neuronitis; Vestibulopathy

Summary: the purpose of this study is to determine the relative merits of vestibular rehabilitation and tai chi for patients with inner ear (vestibular) disorders.

it is proposed a randomized, blinded, controlled trial comparing vestibular rehabilitation (vr) to tai chi (tc). our overall goal is to explore whether, and if so, how tc can improve functional, dynamic stability in persons with vestibulopathy (vsp). it is hypothesized that the tc group will demonstrate significantly greater improvement in performing functional activities than the vr group. sixty subjects will be randomly assigned into either tc instruction or vr. both treatment groups will receive identical duration treatment once a week for 10 weeks, with supplemental home exercises. it is hypothesized that 1) tc improves whole-body dynamic locomotor stability more than does vr; 2) tc improves gait coordination during planned and unplanned obstacle encounters more than does vr; 3) tc improves whole-body speed related movement control more than does vr.

Eligibility criteria:
main inclusion criteria: * vestibulopathy and locomotor unsteadiness main exclusion criteria: * diseases/impairments that prevent rehab participation.

Keywords: rehabilitation tai chi
patient-reported outcomes in neuroendocrine neoplasms: a prospective quality of life and quality of care study within netwerk

Conditions: Quality of Life

Summary: neuroendocrine tumors (net) are rare tumors that require specific diagnosis and treatment. therefore, this poses a challenge for clinical practice. diagnosis and treatment can be optimized when physician specialists and other healthcare providers, across various hospitals, join forces to provide patients the best care. based on this idea, a hospital network called netwerk was set up. the following hospitals are part of this network: university hospital antwerp, vitaz, az monica, az voorkempen, az klina, gasthuiszusters antwerpen, ziekenhuis netwerk antwerpen and az rivierenland. in this netwerk, patients with a neuroendocrine tumor or patients suspected with a neuroendocrine tumor are discussed with the specialists and treated.the aim of this study is to map the quality of life of net patients within netwerk in order to optimize the quality of care. throughout the diagnosis, the treatment process and the follow-up, the patient will be asked to fill out three questionnaires (qlq-c30, qlq-gi.net21 and a satisfaction survey). these questionnaires will be filled out every six months at home. patients will be asked to complete these questionnaires over a period of five years.


Eligibility criteria:
inclusion criteria: * nen patient * 18 years or older * patient should appear in oncobase exclusion criteria: * patients who do not have an email address

Keywords: neuroendocrine neoplasms
safety and tolerability of rns60 given by iv to healthy subjects

Conditions: Myocardial Infarct

Summary: the objective of this study is to evaluate the safety and tolerability of rns60 administered intravenously to healthy subjects. 12 subjects will receive rns60 or placebo at three escalating rates for 48 hours for each rate.


Eligibility criteria:
inclusion criteria: * males between 18-55 years * minimum body weight of 60 kg * bmi of 18-32 kg/m2 * able to execute informed written consent exclusion criteria: * a chronic or acute disease that might interfere with the evaluation of the safety of rns60 * current or prior malignancies (excluding history of treated non-melanoma skin carcinoma) * positive viral serology test for hbsag, hep c antibody, hep a igm, or hiv * use of any prescription medications within 2 weeks of the first day of dosing * significant organ dysfunction, including cardiac, renal, liver, cns, pulmonary, vascular, gi, endocrine or metabolic * treatment with monoclonal antibody therapy within 5 half-lives prior to the first dose of study medication * treatment with any investigational drugs or therapies within 30 days (or 5 half-lives, whichever is greater) prior to the first dose of study medication * abnormal pre-admission vital signs, physical exam, clinical laboratory, or any safety variable considered clinically significant for this population by the pi * subject is considering or has scheduled any surgical procedure during participation in study * history of alcohol and/or dug abuse within 1 year prior to first dose of study medication * subject has donated plasma or blood within 30 days prior to first dose of study medication * subject requires treatment with any medications, either prescription or nonprescription, including dietary supplements or herbal medications, within 14 days prior to the first dose of study medication. exceptions are nonprescription topical medications (that are not systemically absorbed), acetaminophen, or vitamins at recommended daily doses (not mega dose vitamins) * a positive qualitative urine drug or alcohol test * concurrent enrollment in any other clinical trial * subject is judged by pi or medical monitor to be inappropriate for the study - * subject has gilbert's syndrome * subject has estimated creatinine clearance at screening of \<90 ml/min.
ivermectin/ permethrin for scabies

Conditions: Scabies

Summary: scabies is a skin disease characterized by intense itching that worsens at night. it is very contagious, still has a high occurrence rate, and impacts patient quality of life. the use of scabicide followed by a clean and healthy lifestyle is the principle of scabies therapy. the primary treatment option for scabies is permethrin 5% cream. ivermectin is an alternate treatment for scabies.

permethrin acts by disrupting the sodium channel current, resulting in delayed repolarization, paralysis, and death of the parasite. sodium channels are ubiquitous and therefore permethrin acts at all stages of the life cycle of the parasite. permethrin 5% cream is applied overnight once a week for two weeks to the entire body. this drug has a number of negative side effects, such as being expensive, uncomfortable, less applicable, and in some cases resistant to permethrin. ivermectin is an alternate treatment for scabies and should be administered twice, one week apart. ivermectin acts by binding selectively and with high affinity to glutamate-gated chloride ion channels, which are present in invertebrate nerve and muscle cells, resulting in paralysis and death of the parasite. two doses of ivermectin one week apart are recommended for scabies treatment. due to its specific site of action, ivermectin may not be effective against the younger stages of the parasite inside the egg because the nervous system has not yet developed. this drug is safe, more affordable, more practical to use, and has minimal side effects. the disadvantage of ivermectin is it does not kill all the stages of s. scabiei, necessitating multiple doses. according to several earlier research, topical permethrin is just as effective as oral ivermectin at one or two doses. there hasn't been any research on how well three doses of oral ivermectin treat scabies. as a result of no data, our trial is looking forward to answering the comparison of the effectiveness between three dosages of oral ivermectin, two dosages of oral ivermectin, and two applications of topical permethrin in scabies patients.

Eligibility criteria:
inclusion criteria: * male or female * age 6 years or above * body weight 15kg or above * clinical establishment of diagnosed scabies exclusion criteria: * pregnant or breastfeeding woman * scabies with secondary infection * scabies with eczematization * history of receiving scabies treatment in the last four weeks * history of drug hypersensitivity
evaluation of the effect of incorporation of vitamin c into platelet rich fibrin scaffold in treatment of intra-osseous periodontal defects

Conditions: Periodontal Bone Loss

Summary: this study is meant to assess clinically the possible predictable clinical attachment gain regarding the use of vitamin c with platelet rich fibrin versus platelet rich fibrin alone in the treatment of periodontal intrabony defects

treatment of intra-osseous defects through incorporation of vitamin c into platelet rich fibrin scaffold aims to enhance the biologic potential of the endogenous mesenchymal stem cells that exist within the periodontal ligaments and stimulate periodontal tissue regeneration(yan et al., 2013). as the concept of periodontal tissue-engineering has emerged, many inductive biomolecules were investigated for periodontal regeneration(bartold et al., 2000). vitamin c has shown promising results in periodontal regeneration, in a study vitamin c was suggested to enhance osteoblastic differentiation of periodontal ligament cells through modulating type i collagen-α1β2 integrin interaction leading to increased alp activity in periodontal ligament cells(ishikawa et al., 2004). vitamin c treatment induces expression of cementogenic genes and considered to be a more feasible and safer treatment for clinical cell-based periodontal regeneration(gauthier et al., 2017). there is also a study concluding that vitamin c induces the osteogenic differentiation of pdl progenitor cells via pelp1-erk axis; and this implies that vitamin c may have a potential in the periodontal regeneration(yan et al., 2013). periodontal tissue regeneration aims to increase periodontal in intra-osseous defects thus improving clinical attachment level; reducing probing depth and upgrading the prognosis of teeth(ramseier et al., 2012). resolution of intra-osseous defects through regeneration preserves and improves function and provides patient comfort(wang et al., 2005). it also facilitates supportive periodontal therapy; performed regularly to maintain periodontal health(ramseier et al., 2012).

Eligibility criteria:
inclusion criteria: * patient consulting in the outpatient clinic. * able to tolerate surgical periodontal procedures. * patient ready to perform oral hygiene instructions. * compliance with the maintenance program. * provide informed consent. * accept the 6 months follow-up period * mature permanent tooth. * tooth with two or three-walled intra-bony defect, cal ≥ 5mm with intra-osseous defect ≥ 3mm. exclusion criteria: * medically compromised patients. * pregnant or nursing women. * uncooperative patients. * smokers. * teeth with one wall intra-bony defect. * teeth with supra-bony defects. * teeth with grade iii mobility.