Kornimate/medical-research-clean huggingface dataset:
preventing falls and disability in older adults after hip fracture

Conditions: Hip Fracture

Summary: patients who have suffered a first hip fracture have a higher risk of falling and sustaining another hip fracture compared with age-matched adults who did not fracture. although exercise is key to reversing this pattern, there have been very few trials that aimed to improve muscle strength and balance as well as enhance bone health following hip fracture. therefore, we propose to conduct an rct that delivers either 12 months of standard care or standard care plus graduated exercise program for older women who have sustained a recent hip fracture.


Eligibility criteria:
inclusion criteria: * older community dwelling women who have sustained a first hip fracture

Keywords: older women hip fracture exercise intervention
tumor-informed ctdna testing of head & neck intent treatment of squamous cell carcinoma

Conditions: Squamous Cell Carcinoma of Head and Neck

Summary: this is a single-center, non-interventional, observational study that evaluates the correlation of circulating tumor dna (ctdna) testing to cancer relapse for participants with head and neck squamous cell carcinomas (hnc) after curative-intent primary radiation or surgery.

primary objective: i. to determine the rates of detectable ctdna within two years of participants treated with curative-intent surgery or radiation-based treatment for hnc. secondary objectives: 1. to describe the prevalence of detectable ctdna at initial diagnosis in participants with hnc. 2. to describe the association of quantitative ctdna levels with time-to-event outcomes (overall survival (os), disease-free survival (dfs), and time to recurrence (ttr)). 3. to describe the association of quantitative ctdna levels with follow-up imaging tumor volume. outline: participants will have tissue samples collected at screening and blood samples collected for analysis before, during, and after non-investigational, standard of care treatment for cancer for up to 2 years

Eligibility criteria:
inclusion criteria: 1. participants must have histologically or cytologically confirmed squamous cell carcinoma of the head and neck. 2. participants must be age \>=18 years. 3. participants must be planning to receive curative-intent surgery or radiation-based treatment as part of standard of care treatment. 4. participants must have the ability to understand and the willingness to sign a written informed consent document. exclusion criteria: 1. contraindication to phlebotomy for removal of 20 ml of peripheral blood each time point (up to 300 ml total over 15 time points).

Keywords: ctdna
efficacy of electrical dry needling in pain, sensitivity, functionality and quality of life of patients with chronic non-specific low back pain

Conditions: Chronic Low-back Pain

Summary: the main objective of this study is to determine the efficacy of electrical dry needling versus ischemic compression, analytical stretching and postural habits educational dossier in active myofascial trigger points in patients with chronic non-specific low back pain.

a double-blind clinical trial will be developed in a sample of 80 subjects with chronic low back pain. patients in the experimental group will receive electrical dry needling at the active myofascial trigger points (pgm) of the quadratus lumbar, multifidus, and iliocostal muscles (following the pgm maps described by travell and simons). the technique will be performed using needle electrodes, the generated current will be produced by a tens device with a frequency of 2 hz and a pulse width of 250 μs, during 30 min of application. the therapeutic intervention will be 1 weekly session for a total of 6 weeks. the control group will perform an ischemic compression technique in active pgm with a time between 20 seconds and 1 minute until pain inhibition is achieved, and finally, analytical stretching will be carried out on the quadratus lumbar, multifidus and iliocostal muscles. the treatment will consist of 1 weekly session for 6 weeks, in addition they will be provided with a training dossier on postural education in their activities of daily life. a baseline assessment of the primary and secondary outcome measures will be carried out before randomization of the participants to the different groups, an immediate post-treatment assessment (1 day after the last intervention) and an assessment two month after the end of the intervention ( short-term follow-up). the objectives of this study are to compare the repercussions of dry electropuncture versus ischemic compression in active pgm plus stretching in terms of pain, functionality, mobility of the spine, and quality of life in patients with non-specific chronic low back pain; and analyze the impact on active myofascial trigger points in terms of pressure tolerance threshold.

Eligibility criteria:
inclusion criteria: * low back pain ≥ 3 months. * age between 30 and 67 years old. * not being receiving physical therapy. exclusion criteria: * presence of lumbar stenosis. * diagnosis of spondylolisthesis. * diagnosis of fibromyalgia. * treatment with corticosteroids or oral medication in recent weeks. * history of spine surgery. * contraindication of analgesic electrical therapy. * have previously received a treatment of electrical analgesia or exercise. * central or peripheral nervous system disease.

Keywords: electrical dry needling low back pain randomized clinical trial ischemic compression analytical stretch
feasibility of a minimally invasive image-guided surgery system for hepatic procedures

Conditions: Liver Cancer

Summary: this study was designed in two phases: phase i is designed to confirm that the surgeon is able to perform accurate liver surface registration including standard liver features used as landmarks during a scheduled laparoscopic liver ablation procedure and acquires a level of comfort with the procedure. the surface of the liver will be manually swabbed with the study tracked laparoscopic probe with landmarks noted during data collection. after registration of the liver is obtained, the registration points obtained during this procedure will be evaluated by the surgeon by moving the tracked laparoscopic probe over the liver surface and evaluating the location of the tracked laparoscopic probe displayed on the guidance system three dimensional (3d) image. the surgeon will accept or reject the registration accuracy. the hypothesis is that the surgeon will be able to successfully acquire liver surface registrations with a small learning curve for technique and will be able to proceed to phase ii of the study. phase ii contains the registration process included above but adds the additional process of tracking the ablation probe used to perform tumor ablation by attaching the pathfinder multi-tool adaptor and collecting data showing the location of the ablation probe as tracked and displayed on the pathfinder three dimensional (3d) image. the surgeon will use ultrasound (us) guidance to locate tumor location during the laparoscopic procedure. the images collected during this process will be recorded by pathfinder.

the pathfinder system used during this study is used for data collection purposes only and is not used during the surgical procedure as an image guided system. preoperative computed tomography (ct) scans, obtained as standard of care, will be used to generate the image guided liver system 3d liver surface images used during the study. during the laparoscopic procedure, the pathfinder device will be inserted through the standard laparoscopic ports (5mm or 10mm) being used for the staging procedure. a total study population will include 30 subjects: 10 in phase i and 20 in phase ii that complete the laparoscopic procedure scheduled.

Eligibility criteria:
inclusion criteria: * scheduled for laparoscopic liver ablation procedure * had a preoperative ct image that includes the liver exclusion criteria: * severe cirrhosis of the liver * kidney failure or dialysis * unable to consent

Keywords: liver cancer tumor ablation pathfinder
study of non-invasive acupuncture-like transcutaneous electrical nerve stimulation (altens) to help alleviate xerostomia after radiation therapy for cancers of the head and neck

Conditions: Head and Neck Cancer

Summary: the purpose of this study would like to learn if acupuncture-like electrical therapy can be used in patients with head and neck cancer who have had radiation treatment to treat dry mouth.

in this study the investigator would like to better understand if acupuncture-like electrical therapy can be used in patients with head and neck cancer who have had radiation treatment to treat dry mouth. acupuncture has been shown to help some people with symptoms of dry mouth, and low-level electrical stimulation of acupuncture points has been shown to have similar results as acupuncture treatment with needles.

Eligibility criteria:
inclusion criteria: * age \> 18 years * no restrictions on gender or ethnicity * ability and willingness to present for altens therapy over 12 weeks * previous radiation to the head and neck with a dose \> 50 gy * subjective complaint of dry mouth * no evidence of active malignancy in the head and neck region * minimum of 3 months post initial curative therapy with no evidence of active disease by standard of care surveillance scans for said disease site exclusion criteria: * age under 18 years of age * inability to present for altens therapy * inability to fill out quality of life questionnaires * ability and desire to receive concurrent chemoradiation therapy * because altens may stimulate nerves similar to those of pilocarpine, the following exclusions are noted as theoretically altens could produce worse symptoms * unstable angina * unstable cardiac disease with hospitalization in the last 6 months * presence of a pacemaker, icd, or other electronic implanted device that could be affected * myocardial infarction in the last 6 months * symptomatic arrhythmia in the last 6 months * severe copd with exacerbation causing hospitalization within the last 6 months * pregnancy or the possibility of pregnancy

Keywords: acupuncture-like transcutaneous electrical stimulation (altens) head and neck cancer dry mouth
preoperative chemoradiation with capecitabine and cetuximab

Conditions: Rectal Cancer

Summary: * feasibility and tolerance of preoperative therapy with cetuximab in combination with capecitabine and radiotherapy for patients with locally advanced operable rectal carcinoma * collection of response rate (t-downstaging, pathological complete remission), correlation of responsiveness with egfr-status


Eligibility criteria:
inclusion criteria: * age: 18-80 * bioptical confirmed adenocarcinoma of the rectum in operable t3-t4nxm0 status. in spite of infiltration of the neighbouring organs the tumor has to be basically surgically complete resectable * no former chemotherapy, radiotherapy of pelvis or abdomen and/or tumor resection of a rectum carcinoma * who performance status 0-2 * adequate bone marrow reserve (granulocytes - not more than 1.500/µl; thrombocytes - not more than 100.000/µl) * adequate hepatic function ( bilirubin - not more than 1.5 x uln; got and gpt - not more than 3.5 x uln) * adequate renal function (creatinin - not more than 1.5 mg/dl) * women of childbearing potential: exclusion of pregnancy (negative urin or serum pregnancy test) * willingness of women of childbearing potential and accordingly of potent men to use approved contraceptives (e.g. birth-control pill, loop, condom) during and at least 3 month after conclusion of the study * life expectancy of at least 3 month * signed informed consent before recruitment * exclusion of distant metastases at the time of recruitment exclusion criteria: * former radiotherapy of pelvis or abdomen * former chemotherapy * any other kind of malign tumor (except adequate treated skin basalioma or in situ cervical carcinoma) in the last 5 years * general contraindication or known hypersensitivity against cetuximab and/or capecitabine * non malign disease, if there is a contraindication with radiotherapy or chemotherapy with cetuximab and capecitabine or a resection of the rectum: high-graded cardiac insufficiency, angina pectoris, hypertension or arrhythmia, hepatic disease, significant neurological or psychiatric disorders * florid, serious infections at the time of recruitment * legally limited contractual capability or evidence of neurological or psychiatric disease, if it will constrict the patients compliance in the opinion of the investigator * evidence of lacking cooperation of the patient * pregnant or breast feeding women

Keywords: pilot study rectal cancer phase ii preoperative chemoradiation capecitabine cetuximab operable t4 abcsg tako r03 96 06
percutaneous vertebroplasty using rotary cutter for bone metastases

Conditions: Metastasis

Summary: percutaneous vertebroplasty has been applied widely to treat bone metastases. the injected cement may strengthen the affected bone to prevent pathological fractures and relieve the pain. moreover, the thermal reaction (70°c) due to polymerisation of cement also contributes to tumour destruction. the cement dose and diffusion pattern may be significant factors for the treatment efficacy, which can be affected by the inner pressure of the metastases. the investigators will apply a rotary cutter to destroy the structure of metastases to alleviate the pressure in the metastases. then, more cement will be injected, which may effectively interdigitates with the surrounding bone and generate more thermo to kill the tumor cells.


Eligibility criteria:
inclusion criteria: 1. imaging-proven and pathology-proven metastases 2. intractable pain with neurologic dysfunction exclusion criteria: 1. poor general condition without tolerance of surgery
patients' attitudes toward and experiences with buprenorphine treatment

Conditions: Opioid-use Disorder; Acceptability of Health Care; Opioid-Related Disorders

Summary: this study will disseminate five surveys collecting individual's attitudes and experiences during buprenorphine treatment for opioid use disorder during the covid-19 pandemic.

the primary objective of this study is to better understand patients' attitudes and experiences during office-based opioid treatment (obot) in the covid-19 pandemic. this study specifically aims to evaluate attitudes and experiences of people prescribe buprenorphine across five domains with the hope of evaluating a) whether telemedicine has improved their access to and experiences with obot; b) the factors that motivate individuals in obot to abstain from opioid drug use; c) how patients' view the use of cannabis, benzodiazepines, and nicotine during obot; d) the degree to which patients in obot report using cannabis, benzodiazepines, and nicotine and how their use might have changed during the covid-19 pandemic; and e) whether patients attitudes towards cannabis, benzodiazepines, and cigarettes/e-cigarettes are associated with their use of those same substances.

Eligibility criteria:
inclusion criteria: * participants must be 18 years of age or older. * participants report currently having a legal prescription for buprenorphine for opioid use disorder. * participants must have a past or present opioid use disorder. * participants must currently reside in the state of massachusetts. * participants must be able to comprehend the english language. exclusion criteria: * unable to complete an online survey. * unable to complete a verification step that ensures bots are not used to complete survey. * complete a survey with no variation suggesting they did not read the survey.

Keywords: opioid use disorder substance use disorders buprenorphine suboxone cannabis cigarettes e-cigarettes benzodiazepines healthcare covid-19 telemedicine office-based opioid treatment facebook social media nicotine recovery
feasibility of mini-eeg in the prehospital setting

Conditions: Epilepsy; Coma

Summary: the eeg is widely used in the diagnosis of central nervous system pathology, including epileptic seizures and epilepsy. presently, eeg is available only during office hours in most hospitals, pending on the availability of a clinical neurophysiologist and the lack of oncall possibility outside these hours. standard eeg devices are large and their operation require meticulous application of several leads. the department of clinical neurophysiology at helsinki university central hospital has developed a mini-eeg device for use in the emergency department as well as in the prehospital setting. the aims of this pilot study is to evaluate the feasibility of the mini-eeg in the prehospital setting. patients with a decreased level of consciousness, as evaluated by the emergency medical provider on the scene, are included. the mini--eeg device is to be used by a specially trained emergency medical supervisor. eeg is otherwise obtained in a normal fashion, but only three electrodes are used. the sample size is 30. data are collected as a part of the clinical work in daily practice. the aim is to collect observational data on feasibility, no clinical interventions will be performed based on the eeg. no funding is needed as data is collected during daily work. the mini-eeg is a prototype eeg/ekg-adapter, designed by helsinki univeristy central hospital, and as such, does not have a trade name. it is to be connected to a monitor/defibrillator used by the ems personel, currently the lifepak 15, manufactured by physio-control, redmond, wa 98052. (www.physio-control.com)


Eligibility criteria:
inclusion criteria: * unconsciousness resulting in activation of the local ems units exclusion criteria: * cardiac arrest * traumatic unconsciousness * transient unconsciousness

Keywords: emergency care, prehospital electroencephalography coma
osteopathic thrust and muscle-energy manipulations on sacroiliac joint dysfunction

Conditions: Sacroiliac Disorder

Summary: this study assesses the effect of manipulative techniques of thrust and muscle-energy over the sacroiliac joint on plantar foot support, weight distribution in the lower limbs and balance in amateur runners with sacroiliac dysfunction. participants will be randomly assigned to one of 3 manipulations (i.e., intervention): thrust, muscle-energy or placebo.

the thrust manipulation applies a high velocity and intensity push in a specified direction to correct the position or movement of the sacroiliac joint. the muscle-energy technique consists of the therapist correcting the sacroiliac joint while the participant is applying active resistance. for the placebo manipulation, participants will receive a false manipulation over the affected joint, without producing movement at the sacroiliac joint.

Eligibility criteria:
inclusion criteria: * amateur runners who perform between 10-30 km per week) and present a sacroiliac joint dysfunction. exclusion criteria: * low back pain * vertebral bone pathology * radicular neurological condition * fracture or recent surgical intervention in the lumbosacral or pelvic region * anatomical short leg with a difference greater than 0.5 cm * pregnant * fear of manipulation technique

Keywords: osteopathy baropodometry
next-generation-sequencing approach to neutropenic sepsis

Conditions: Febrile Neutropenia

Summary: the aim of this prospective, observational, non-interventional, multi-centre study of the diagnostic use of disqver in neutropenic patients with fn is to provide further evidence of the efficacy of an ngs-based approach for detecting bloodstream infection in neutropenic patients.

the aim of this prospective, observational, non-interventional, multi-centre study of the diagnostic use of disqver (platform for digital pathogen diagnostics from noscendo gmbh) in neutropenic patients with fn (febrile neutropenia) is to provide further evidence of the efficacy of an ngs (next-generation seqzencing)-based approach for detecting bloodstream infection in neutropenic patients.

Eligibility criteria:
inclusion criteria: * age ≥18 years * informed consent * neutropenia defined as \<500 anc (absolute neutrophil count)/µl or \<1000 wbc (white bloddcell count)/µl if anc is not available * fever (with an onset \< 24h) or sepsis (with an onset \<24h) patients with a life-threatening - organ dysfunction caused by a dysregulated host response to a suspected or proven infection. exclusion criteria: * age \< 18 years * refusal or inability to give consent inability to give informed consent if no acceptable patient representative is available * patients who had previously been included, but develop a new episode of fever during the same hospitalization, will not be included a second time * death is deemed imminent and inevitable
a first in human study to assess the safety, tolerability and pharmacokinetics of single and multiple ascending doses of qcc374

Conditions: Healthy Subjects

Summary: this is a double blind, randomized, placebo controlled, single and multiple ascending dose study in healthy subjects. safety evaluation will include (serious) adverse events, vital signs, body weight and lung function tests. blood samples for pharmacokinetics will also be drawn at specified timepoints.


Eligibility criteria:
inclusion criteria: 1. written informed consent must be obtained before any assessment is performed. 2. healthy male and female subjects age 18 to 55 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening. 3. weight of at least 50 kg and body mass index (bmi) within the range of 18 - 32 kg/m2. bmi = body weight (kg) / \[height (m)\]2. 4. oxygen saturation (o2) at screening must be ≥ 95% on room air. 5. fev1 ≥ 90% predicted. exclusion criteria: 1. 1. a history of clinically significant ecg abnormalities and/or orthostatic vital signs at screening. 2. history of asthma or reactive airway diseases. 3. smokers or anyone who smoked within 5 years of screening. urine cotinine levels ≥ 500 ng/ml. 4. history of malignancy of any organ system other than localized basal cell carcinoma of the skin, treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. 5. women of child-bearing potential

Keywords: healthy subjects, inhaled