Kornimate/medical-research-clean huggingface dataset:
clinical performance of a new implant system for bone conduction hearing

Conditions: Deafness; Sensoneural Single Sided; Conductive Hearing Loss; Mixed Hearing Loss

Summary: to study the initial experience with implanting and fitting the new bone conduction system in patients with conductive, mixed or single sided sensorineural deafness.


Eligibility criteria:
inclusion criteria: * adult subjects (18 years or older) * subject with conductive or mixed hearing loss in the ear to be implanted. bone conduction thresholds with pure tone average (pta4; mean of 0.5, 1, 2 and 4 khz) of 55 db hl. or subject with single-sided sensorineural deafness who is a candidate for baha surgery. air conduction thresholds with a pure tone average pta4 of 20 db hl (mean of 0.5, 1, 2 and 3 khz) in the good ear or subject who is indicated for an ac cros but-for some reason-cannot or will not use an ac cros (air conduction-contralateral routing of signal). * signed informed consent * previous experience from amplified sound though a non-surgical solution. (for example but not limited to hearing aid, cros device, bone conductional hearing device on headband/ softband) exclusion criteria: * uncontrolled diabetes as judged by the investigator. * condition that could jeopardise osseointegration and/or wound healing (e.g. osteoporosis, psoriasis, long-term systemic use of corticosteroids) or condition that may have an impact on the outcome of the investigation as judged by the investigator. * insufficient bone quality and quantity for implantation of a bi300 implant. * subject that has received radiotherapy in the area of implantation, or is planned for such radiotherapy during the study period * use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator * unable to follow investigational procedures, e.g. to complete quality of life scales. * participation in another clinical investigation with pharmaceutical and/or device.
fmri study of the neural mechanism of rtms in the treatment of nicotine dependence

Conditions: Tobacco Use Disorder; Repetitive Transcranial Magnetic Stimulation

Summary: the goal of this clinical trial is to investigate the efficacy of treatment and the efficacy-related neural network mechanisms by stimulating the left dorsolateral prefrontal lobe with rtms to nicotine dependent. the main questions it aims to answer are: * efficacy of left dorsolateral prefrontal rtms in the treatment of nicotine dependent subjects. * the relationship between therapeutic effect and the internal function of the large brain networks of ecn, dmn and sn, and the changes in the interaction between the networks.

participants will randomly divided into two groups，relevant psychological and behavioral data and fmri data were collected first, and then rtms was continuously treated for 2 weeks. the above data were collected again after the treatment ended, and then the follow-up was conducted for 1 month. psychobehavioral data were collected once a week for nicotine addicts.finally, the collected neuroimage data were analyzed to compare the difference in efficacy between the true and false treatment groups, and to clarify the relationship between the efficacy of nicotine dependent patients after rtms treatment and the internal functions of the large brain networks of ecn, dmn and sn as well as the interaction characteristics of the networks, so as to provide a scientific basis for the development of effective individualized treatment programs.

Eligibility criteria:
inclusion criteria: * meets the dsm-v diagnostic criteria for addiction * pure nicotine dependence * did not receive medication * right-handed exclusion criteria: * patients with organic brain lesions and a history of severe head trauma * compliance is poor * multiple drug abusers * current or past history of mental or neurological disorders * there was a metallic foreign object in his body * people with pacemakers
clinical trial of intravitreal injection of autologous bone marrow stem cells in patients with retinitis pigmentosa

Conditions: Retinitis Pigmentosa

Summary: the purpose of this study is to evaluate the safety of intravitreal injection of autologous bone marrow stem cells in patients with retinitis pigmentosa by a prospective, single-center, randomized, parallel, double-blind, phase i placebo-controlled clinical trial.


Eligibility criteria:
inclusion criteria: * retinitis pigmentosa bilateral diagnosis. * visual acuity (measured with etdrs) less than or equal to 20/70 and visual field below 30° central in both eyes. * signed informed consent * warranty sufficient adherence to protocol. it must fulfill all inclusion criteria. exclusion criteria: * concurrence of any systemic or ocular disease that precludes or affects tracking study variables. specifically retinal involvement with diabetes mellitus, glaucoma, macular degeneration or age. * eye surgery in the previous 6 months. * patients who are pregnant. * patients with active lactation. * physically fertile patients, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle or sexual orientation excludes sexual intercourse with a man and women whose partners have been sterilized by vasectomy or other methods, unless they are using a reliable contraceptive method. this birth control method can be: * complete abstinence from sexual intercourse * surgical sterilization (tubal ligation) * surgical sterilization partner (vasectomy) * implanted or injectable hormonal contraceptives and oral. * patients with cardiac disease, renal, hepatic, systemic, immune that might influence the survival of patients during the test. * positive serology for hepatitis b, hepatitis c or hiv. * clinical criteria or anesthetics that contraindicate the sedation or the extraction of bm (altered coagulation system or anticoagulated patient with inability to withdraw anticoagulation, hemodynamic instability, altered skin in the puncture site, etc.) * participation in other clinical trials. * inability to sign informed consent or understanding.
prediction of fluid responsiveness in children with single ventricle

Conditions: Hypovolemia

Summary: the purpose of this study is to evaluate predictability of an abdominal compression-induced change of blood pressure for fluid responsiveness in children with single ventricle (bidirectional cavopulmonary shunt and fontan tract).

the purpose of this study is to evaluate predictability of an abdominal compression-induced change of blood pressure for fluid responsiveness in children with single ventricle (bidirectional cavopulmonary shunt and fontan tract). when there are clinical signs of hypovolemia, such as hypotension, decreased urine output or decreased central venous pressure, right upper abdomen is gently compressed for 10 seconds. changes of blood pressure are continuously recorded during this period. about 3 min later, intravenous colloid fluid 10 ml/kg is infused for 20 min. to evaluate the change of cardiac output, transesophageal or transthoracic echocardiography is performed before and after fluid administration. in addition, hemodynamic parameters including pulse pressure variation, systolic pressure variation, pleth variability index and central venous pressure are also recorded before and after fluid administration. finally, patients will be divided into fluid responder group and non-responder group. if cardiac output measured using echocardiography increases over 15% after fluid administration, the patient is fluid responder. using roc curve, diagnostic power of abdominal compression-induced blood pressure change for fluid responsiveness will be evaluated

Eligibility criteria:
inclusion criteria: * pediatric patients undergoing elective surgery, who require invasive blood pressure and central venous pressure monitoring during surgery * patients with bidirectional cavopulmonary shunt or fontan tract exclusion criteria: * renal, hepatic and pulmonary disease * preoperative infection: increased cpr, wbc over 10,000, and with fever * genetic and hematologic disease * ventricular dysfunction * increased intracranial pressure
individual patient expanded access-glembatumumab vedotin

Conditions: Metastatic gpNMB Expressing Triple Negative Breast Cancer

Summary: celldex endeavors to make investigational products available to patients with life-threatening diseases who have exhausted other treatment options and where there is a reasonable expectation of benefit over risk. requests for expanded access to glembatumumab vedotin in patients with gpnmb expressing triple negative breast cancer will be considered.


Eligibility criteria:
inclusion criteria: 1. the patient is 18 years of age or older. 2. the patient has histologically confirmed, gpnmb expressing, metastatic triple-negative breast cancer 3. overexpression of gpnmb in at least one tumor sample as determined by a sponsor approved laboratory using ihc methods 4. the patient does not have abnormal organ function, active autoimmune disease, active infections or additional concurrent conditions that would compromise the patient's ability to safely receive glembatumumb vedotin. 5. the patient is not eligible for or cannot access ongoing glembatumumab vedotin clinical trials 6. the patient does not qualify for, or cannot access, other comparable or satisfactory alternative therapy for triple negative breast cancer. 7. the patient is able to read and understand, and has signed a patient informed consent form, which outlines the nature of the proposed treatment and the anticipated benefits and risks of treatment with glembatumumab vedotin. exclusion criteria: 1. history of allergic reactions attributed to compounds of similar composition to glembatumumab vedotin, mmae, dolastatin or auristatin. 2. pregnant or breast-feeding women, and women or men who are not willing to use effective contraception during the time from signing of informed consent through two months after the last dose of glembatumumab vedotin treatment. 3. the patient was previously treated with glembatumumab vedotin or previously enrolled on the metric trial (regardless of which arm they were randomized to). 4. any underlying medical condition that, in the investigator's or sponsor's opinion, will make the administration of glembatumumab vedotin hazardous to the patient, or would obscure the interpretation of adverse events.
video decision aid in latina women with pelvic organ prolapse

Conditions: Pelvic Organ Prolapse

Summary: pelvic organ prolapse (pop) is a highly prevalent condition among women that impairs quality of life, daily activities and sexual function. latina women are disproportionally affected, with significantly higher rates of pop compared to women of other ethnicities. decision aids have been used to increase patient knowledge prior to physician intervention and to facilitate informed patient participation on treatment selection. the investigators hypothesize that the use of a video decision aid prior to initial urogynecology specialist evaluation of latina women with pop in a border region university-affiliated medical clinic, will increase patient knowledge regarding the condition, decrease decisional conflict regarding selection among different treatment options and increase patient satisfaction with selected treatment.

pelvic organ prolapse (pop) is a highly prevalent condition among women that impairs quality of life, daily activities and sexual function. latina women are disproportionally affected, with significantly higher rates of pop compared to women of other ethnicities. counseling latina women suffering from pop is often complex due to a variety of factors, including language barriers, limited patient understanding of anatomy and disease etiology and confusion regarding surgical versus nonsurgical treatment options. decision aids have been used to increase patient knowledge prior to physician intervention and to facilitate informed patient participation on treatment selection. the investigators hypothesize that the use of a video decision aid prior to initial urogynecology specialist evaluation of latina women with pop will increase patient knowledge regarding the condition, decrease decisional conflict regarding selection among different treatment options and increase patient satisfaction with selected treatment, empowering these women as active participants in their healthcare instead of relying on provider input alone.

Eligibility criteria:
inclusion criteria: * hispanic women * referred for evaluation of pelvic organ prolapse for the first time exclusion criteria: * women previously referred or treated for pelvic organ prolapse * women who do not live in el paso, texas

Keywords: decision aid pelvic organ prolapse (pop)
ranibizumab plus indomethacin

Conditions: Macular Edema

Summary: to evaluate whether indomethacin eyedrops plus intravitreal ranibizumab (ivr) provides additional benefit over ivr monotherapy for treatment of choroidal neovascularization (cnv) in age-related macular degeneration.


Eligibility criteria:
inclusion criteria: * provision of written informed consent and compliance with study assessments for the full duration of the study * age \> 40 years * presence of treatment-naïve neovascular amd. exclusion criteria: * any previous intravitreal treatment * previous laser treatment in the study eye * myopia \> 7 diopters in the study eye * concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy and advanced glaucoma) * concurrent corneal epithelial disruption or any condition that would affect the ability of the cornea to heal * known sensitivity to any component of the formulations being investigated.
the effect of powered-knee exoskeleton assist on stair climbing in acute cva

Conditions: Stroke, Acute; Gait Disorders, Neurologic

Summary: hypothesis/specific aims: the purpose of this research study is to determine if using an exoskeleton during stair climbing training will result in an improved ability to walk and climb stairs in individuals affected by recent stroke as compared to stair climbing training without an exoskeleton.

participants will be randomized into one of two groups. group 1 will wear the exoskeleton device while completing all training sessions. group 2 will not wear the exoskeleton device during training sessions. all screening and evaluation sessions will be completed without the exoskeleton device for both group 1 and group 2. pre and post-session vitals (blood pressure, heart rate) will be taken and monitored throughout the session as needed. gait belts and/or overhead track and harnessing systems will be used throughout sessions as needed for increased safety of participants. skin integrity will also be monitored both before and after each use of the exoskeleton device. each enrolled participant will complete the following sessions: session 1: screening * after consenting, subjects will undergo a physical evaluation and screening exam by a licensed physical therapist. if they meet study criteria, they will be randomly placed into either the keeogo group or the traditional stair training group using a random number generator and they will be entered into the study. once they are enrolled, baseline outcome measures will be assessed. sessions 2 through 6: training * subjects will participate in 30 minutes of stair training with or without the exoskeleton device, depending on group assignment. session 7: post-testing * outcomes measures will once again be assessed by a licensed physical therapist.

Eligibility criteria:
inclusion criteria: * patient in the inpatient rehabilitation setting * less that 3 months post-hemorrhagic or ischemic cerebrovascular accident (cva) * no previous diagnosis or treatment for cva * acute inpatient rehabilitation discharge goal of stair negotiation * 18 years of age or older * waist and leg circumference and lower extremity lengths appropriate for a comfortable and safe fit in the keeogo study device * medical clearance from a shirley ryan abilitylab (sralab) inpatient physician exclusion criteria: * unwilling to participate * unable to provide autonomous consent due to cognitive or communication impairment * legally blind * pregnant or lactating * skin condition that contraindicates use of orthotics or support braces * history of multiple cva * history of any additional neuropathology diagnosis, such as parkinson's disease, multiple sclerosis, traumatic brain injury, or spinal cord injury

Keywords: powered-knee exoskeleton stair training keeogo
a study to observe the performance of a tablet form of pf-04531083 as evidenced by the concentration of pf-04531083 in the blood with time following oral administration to healthy volunteers.

Conditions: Chronic Pain

Summary: a new tablet form of pf-04531083 has been manufactured. previously the compound was administered as a solution/suspension to healthy volunteers. this study will investigate the pharmacokinetics of pf-044531083 in tablet form and compare with the pharmacokinetics obtained, with the same dosing regimen, with the solution/suspension.


Eligibility criteria:
inclusion criteria: * young * healthy volunteers exclusion criteria: * elderly volunteers * patients with any existing medical conditions considered likely to impinge on study execution

Keywords: pharmacokinetics tablet performance healthy volunteers open label
the effect of calcium on postprandial lipid profile and appetite

Conditions: Obesity

Summary: the purpose of this study is to investigate the effect of calcium on postprandial lipid profile and appetite.

several reports have found inverse associations between calcium intake and body weight. intervention studies have shown that a high calcium diet resulted in a greater body weight loss than a low calcium diet. in addition, it seems that calcium from dairy products have a more profound effect than calcium from supplements. the mechanism of this additional dairy effect is not yet clear, but one possible explanation could be reduced absorption of fat in the gut. the increase in fecal fat excretion on a high calcium diet could be due to the formation of calcium-fatty acid soaps in the gut. the long term effect of a high calcium intake have been under intense investigation, but as far as we know the acute effect of a high calcium intake have not yet been examined. a study concerning the acute effects could help us understand the effect of calcium on the absorption of fat. after a meal triglyceride (tg) is packaged with cholesterol, lipoproteins and other lipids into particles called chylomicrons. earlier studies have shown that the fatty acid pattern of chylomicron lipids postprandial was very similar to that of the ingested fat. if we assume that calcium inhibits the absorption of fat, we would expect a reduced total plasma triglyceride concentration after a calcium-rich meal. appetite involves many different sensations among which hunger and satiety are the most investigated. several different hormones are involved in the regulation of appetite. some of these hormones are known to respond to the intake or absorption of fat. if the absorption of fat is inhibited the regulation of appetite most likely will be affected. in the long term this could be important because an increased appetite probably would increase energy intake and thereby reducing the weight loss we otherwise might have accomplished by the reduced absorption of fat.

Eligibility criteria:
inclusion criteria: * healthy meals * bmi 24-31 kg/m2 * age between 18-50 years * hemoglobin \>8 mmol/l exclusion criteria: * donation of blood 6 months before and under the study * milk allergy, diabetes, hypertension, hyperlipidemia, cronic infectious disease * use of dietary supplements 3 months before and under the study * smoking * elite athletes * use of medication

Keywords: obesity calcium fat absorption postprandial lipid profile appetite
safety and efficacy of synthetic human secretin-enhanced mrcp in subjects with abnormalities of the pancreas

Conditions: Pancreatitis

Summary: the purpose of this study is to evaluate the safety and effectiveness of rg1068 (synthetic human secretin) with mrcp in subjects with abnormalities of the pancreas.


Eligibility criteria:
inclusion criteria: * history of pancreatitis * medically stable * able to give informed consent exclusion criteria: * prior history of pancreatic resection * prior history of pancreatic duct drainage procedure * presence of a pancreatic stent * unstable cardiovascular disease * any contraindication to mri procedure * pregnancy

Keywords: secretin, rg1068, mrcp, pancreas
applied topical heat as an adjunct for pain control in first-trimester surgical abortionl

Conditions: Topical Heat Application for Intraoperative Abortion Pain Management

Summary: paracervical blocks are routinely used in first trimester surgical abortions and are a proven method for decreasing procedural pain. even when paracervical anesthesia is used, an overwhelming majority of women still report at least moderate pain during a first trimester abortion procedure. other than some non-pharmacologic modalities (music and visualization), only the addition of intravenous medication has been shown to reduce procedural pain. applied topical heat is effective in alleviating pain in other medical subspecialties, and in gynecology has been shown to reduce pain from dysmenorrhea, but has never been studied for intraoperative pain control during first trimester abortion. the investigators plan to conduct a double-blinded, randomized, controlled trial investigating the utility of topical heat application as an adjunct to paracervical block in first trimester surgical abortions up to 12 6/7wks. the primary outcome is pain score, measured using vas, at time of uterine aspiration. as secondary outcomes, the investigators will look at the effect of heat application on pain at time of speculum placement, paracervical block, tenaculum placement, cervical dilation and overall pain. patient satisfaction will also be assessed. if found to reduce pain during abortion under local anesthesia, the use of heat could offer an inexpensive, safe and universally available adjunct to the paracervical block during this procedure.


Eligibility criteria:
inclusion criteria * gestational age of 12 6/7 wks or less by ultrasound * age 16 years or older * requesting pregnancy termination by surgical abortion * eligible for outpatient pregnancy termination * able to provide informed consent * english or spanish\* speaking \*if research assistant hired for project is bilingual * electing local anesthesia only exclusion criteria * reports active bleeding or severe pain at time of enrollment * early pregnancy failure identified on pre-operative ultrasound * skin irritation or rash over lower abdomen * presumed molar pregnancy * possible ectopic pregnancy * electing intravenous sedation * planned intra-operative sonographic guidance