Kornimate/medical-research-clean huggingface dataset:
real world study of the tendyne™ mitral valve system to treat mitral regurgitation

Conditions: Mitral Valve Regurgitation

Summary: to evaluate the safety and performance of the tendyne™ mitral valve system when used as intended in a contemporary, real-world setting.

the tendyne resolve-mr study (real world study of the tendyne™ mitral valve system to treat mitral regurgitation) is a prospective, single arm, multi-center, pmcf study, which will be used to support the ce mark requirement of monitoring safety and performance for any complications or issues arising in a post-market setting. the objective of the tendyne resolve-mr study is to confirm the safety and performance of the tendyne mitral valve system in patients with symptomatic, moderate-to-severe or severe mitral regurgitation (mr) who are considered by the local heart team as eligible for a transapical transcatheter mitral valve implantation in a real-world setting. this clinical study is intended to satisfy post-market clinical follow-up requirements of ce mark.

Eligibility criteria:
inclusion criteria: 1. patient is indicated for the tendyne mitral valve system per the instructions for use. 2. patient is willing and able to comply with all follow-up requirements through five years, including study-required testing, medications, and attending all follow-up visits. 3. patient provides written informed consent prior to any study-specific procedure. exclusion criteria: 1. patient is in another clinical study that may impact the follow-up or results of this study. 2. patient is pregnant or nursing or plan to become pregnant during the study follow-up period. 3. patient is under the age of 18 or age of legal consent. 4. patient has other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, may limit the subject's ability to participate in the clinical study or to comply with follow-up requirements.

Keywords: tendyne tendyne mitral valve system transcatheter mitral regurgitation heart valve disease mitral valve regurgitation mitral insufficiency transcatheter intervention transcatheter mitral valve implantation transcatheter mitral valve replacement transapical transcatheter mitral valve implantation
validity of the 6-minute pegboard and ring test in parkinson's patients

Conditions: Parkinson Disease

Summary: tests used to assess upper extremity endurance in parkinson\&#39;s patients are limited. this study aimed to investigate whether the 6-minute pegboard and ring test (6-mprt), which has been validated in many respiratory disease groups in previous studies, is an endurance assessment battery that can also be used in parkinson\&#39;s patients. 6-mprt, weight lifting test, and 30-second arm curl test will be applied in the assessments. assessments will be made twice on the same day by two different evaluators, 1 hour apart. after the first evaluation, the patient will be called for the second time 2 days later, and the same procedure will be repeated.


Eligibility criteria:
inclusion criteria: * hoehn \& yahr staging ≤3 points, * individuals who have not undergone a rehabilitation program of at least 20 days in the last 6 months, * those with full upper extremity shoulder flexion and abduction active joint range of motion. exclusion criteria: * those with severe heart disease such as heart failure, cardiac arrhythmia, hypertension, * people with any orthopedic problem that will affect the upper extremity, * having a secondary neurological disease diagnosis, * having vision impairment that may affect measurement methods (not corrected by glasses), * having a cognitive disease that may cause difficulty in following the researchers\&#39; commands, * those who had changes in their medical use during the test (dose increase/decrease, drug change

Keywords: parkinson validity 6-minute pegboard and ring test
vigabatrin for the treatment of cocaine dependency

Conditions: Cocaine Addiction; Cocaine Dependence

Summary: the objective of this 26-28 week study is to demonstrate that the rate of cocaine dependent subjects treated with cpp-109 vigabatrin in addition to counseling, who completely stop use of cocaine in the last 2 weeks of the study's treatment phase (weeks 8 and 9) will be higher than seen in subjects treated with placebo in addition to counseling.

the objective of this 26-28 week study is to demonstrate that the rate of cocaine dependent subjects treated with cpp-109 vigabatrin in addition to counseling, who completely stop use of cocaine in the last 2 weeks of the study's treatment phase (weeks 8 and 9) will be higher than seen in subjects treated with placebo in addition to counseling. there are 3 phases to this study: * a 2-4 week screening/baseline phase during which eligibility to be included in the trial will be tested; * a 9 week treatment phase during which subjects will receive cpp-109 or placebo tablets in addition to counseling; and * a 15 week follow-up phase, during the first 4 weeks (weeks 10-13) of which subjects will continue to receive counseling.

Eligibility criteria:
inclusion criteria: * able to understand the study and provide written informed consent. * male or female at least 18 years of age. * meet dsm-iv criteria for cocaine dependence as primary diagnosis, as determined by the substance abuse structured clinical interview (scid) for diagnostic and statistical manual-iv (dsm-iv) module. * have a verifiable place of primary residence. * seeking treatment for cocaine dependence. * be in generally good health based on history, physical examination, electrocardiogram, eye exam and laboratory findings. * if female of childbearing potential, use acceptable contraceptive methods (oral contraceptives (the pill), intrauterine device (iud), contraceptive implants under the skin, contraceptive rings or patches or injections, diaphragms with spermicide, and condoms with spermicide). surgical sterilization by tubal ligation or hysterectomy is acceptable. exclusion criteria: * please contact site for more information

Keywords: cocaine cocaine addiction treatment cocaine treatment vigabatrin cpp-109 catalyst national institute on drug abuse
burden of respiratory syncytial virus (rsv) in the united kingdom from 1995 to 2009

Conditions: Respiratory Syncyctial Virus Vaccines

Summary: the study will assess the burden of rsv-attributable general practice consultations, hosptializations, and deaths by age and risk group in in united kingdom from 1995 to 2009.

this epidemiological study is based on an already existing database of time series regression modeling outputs generated during the generated by epi-flu-018 bod uk db (116273) study, which estimated the burden of influenza in terms of general practitioner (gp) consultations, hospitalizations, and deaths associated with various respiratory and non-respiratory outcomes.

Eligibility criteria:
inclusion criteria: • included in the epi-flu-018 bod uk db bod uk db (etrack: 116273) study database. the inclusion criterion for epi-flu-018 was registration with an acceptable flag in the cprd, or registration in the hes database or the ons mortality data with a flu-related event. exclusion criteria: • not applicable

Keywords: general practice research database burden of disease clinical practice research datalink hospital episode statistics office of national statistics rsv
exploration of gait biomechanics and pain

Conditions: Pain; Healthy

Summary: this interventional study aims to test gait biomechanics in healthy individuals with and without experimental knee pain. the main questions it aims to answer are: * how do gait patterns change during painful walking? * can pain sensitivity testing and gait biomechanics predict experimental knee pain intensity? participants will receive two knee injections: a) hypertonic saline (painful condition) and b) isotonic saline (control condition).

this study will be a randomized, crossover design where experimental knee pain will be provoked in healthy subjects using hypertonic saline injections to the infrapatellar fat pad (ifp). this will be controlled with a second injection of isotonic saline, which is non-painful. the participants will not be informed of the type of injection. hypertonic saline injections to the ifp usually provoke pain lasting about 15 minutes. within this timeframe, motion capture will be conducted to estimate the biomechanics of gait. during the motion capture the participants will perform five 10-meter walking trials and three jumps. this process will be replicated for the control condition. additionally, the participants will have their pain sensitivity tested using cuff-pressure algometry before both ifp injections.

Eligibility criteria:
inclusion criteria: * healthy men and women aged 18-45 years exclusion criteria: * pregnancy * drug addiction, defined as the use of cannabis, opioids, or other drugs * previous or current neurologic or musculoskeletal illnesses * current pain * lack of ability to cooperate
hyperbaric oxygen post established stroke

Conditions: Stroke; Ischemic Stroke; Established Stroke

Summary: the purpose of this study is to examine the role of hyperbaric oxygen therapy (hbot) in improving neurological function in patients who are 6 to 36 months post ischemic stroke.

the purpose of this study is to examine the role of hyperbaric oxygen therapy (hbot) in improving neurological function in patients who are 6 to 36 months post ischemic stroke. hyperbaric oxygen therapy (hbot) involves the administration of inhaled 100% oxygen at increased ambient pressure inside a closed vessel. hbot produces greatly elevated arterial and tissue oxygen tensions, producing a wide variety of physiological effects at the cellular and sub cellular level. some of these effects have been postulated to be beneficial in the context of ischemic stroke. most of the recovery after stroke occurs in the first 30 to 90 days after the acute event. recovery is largely based on recovery of brain that is injured, but viable. physiological imaging studies (pet, eeg) have demonstrated that brain tissue may remain alive but not functional for months or years after ischemic insult. subjects will be selected from the stroke population based on an expectation that they would experience a clinically significant improvement. eligible subjects will have suffered an ischemic stroke involving the cerebral cortex within the last 6 to 36 months. the study will be enrolling 140 subjects and will be randomized to two different treatment arms: experimental group and a waitlist group. each subject will receive a series of forty 2 hour treatments, delivered once a day, 5 days a week, within the hyperbaric oxygen chamber.there will be assessments completed before treatment series begins, 3 weeks and 6 weeks into treatment and then again at the end of treatment. after treatment ends, the investigators will conduct these assessments again at 3 months, 6 months, 9 months and 1 year from the date of the participants last treatment.

Eligibility criteria:
inclusion criteria: 1. age between 19 and 85. 2. able to speak english and give informed consent or have a substitute decision maker and able to assent. 3. one or more ischemic stroke(s) involving the cerebral cortex or cerebellum within the last 6 to 36 months 4. able to sit in the chamber with the assistance of a waist and chest strap for 120 minutes. exclusion criteria: 1. contraindication to hbot (appendix c) including: 1. untreated collapsed lung (pneumothorax) 2. have taken the chemotherapy drug doxorubicin within 72 hours 3. have taken the chemotherapy drug bleomycin within 4 months 4. bowel obstruction 5. heart pacemaker of unknown make and model 6. pregnancy 7. cigarette smoking 8. chronic obstructive pulmonary disease (copd) 2. participation in other stroke related studies. 3. previous history stroke \> 36 months prior to study baseline

Keywords: hyperbaric oxygen hbot hyperbaric chamber pressurized oxygen
adiponectin and ethnic differences in insulin resistance

Conditions: Insulin Resistance; Type 2 Diabetes

Summary: the purpose of this protocol is to measure and compare levels of the circulating protein adiponectin and adiponectin's association with insulin sensitivity in mexican americans and non-latino white subjects. the investigators also aimed to examine associations between nutritional factors and adiponectin levels.


Eligibility criteria:
inclusion criteria: * 18-60 years of age * bmi 20.0-34.9 m/kg2 * mexican american with at least 3 grandparents born in mexico or white with no grandparents of latino descent. exclusion criteria: * pregnancy * breastfeeding * diabetes mellitus * blood pressure \> 160/100 mmhg * creatinine \> 1.5 mg/dl or glomerular filtration rate (gfr) \< 60 * liver function tests \> 3x upper limit of normal (uln) * h/o heart failure * h/o eating disorder

Keywords: insulin resistance ethnic disparities adiponectin
coretox® in treatment of post stroke upper limb spasticity (phase3)

Conditions: Muscle Spasticity

Summary: the purpose of this study is to evaluate the efficacy and safety of coretox® in the treatment of post-stroke upper limb spasticity


Eligibility criteria:
inclusion criteria: * male or female patients ≥ 19 years * ≥ 6 months since the last stroke * ≥ 2 points in the focal spasticity of wrist flexor and ≥ 1 point at least one of elbow flexor and finger flexor as measured on mas(0 to 4) * informed consent has been obtained exclusion criteria: * neuromuscular disorders such as lambert-eaton syndrome, myasthenia gravis, or amyotrophic lateral sclerosis * history(within 4 months of screening visit) or planned(during study period) treatment with phenol or alcohol injection or surgery in the target limb * history(within 4 months of screening visit) or planned(during study period) treatment with tendon lengthening in the target limb * fixed joint/muscle contracture * severe atrophy * concurrent treatment with an intrathecal baclofen * patients who have bleeding tendency or taking anti-coagulant * dysphagia and breathing difficulties * history(within 4 months of screening visit) planned(during study period) treatment with botulinum toxin * known allergy or sensitivity to study medication or its components * concurrent or planed muscle relaxants and/or benzodiazepine medication if patient has taken these medication stable from one month before screening and no treatment changes are not planned during the study, participation is allowed. * current physical, occupational, splinting therapy these therapy regimens will be permitted if they have been stable in the one month before screening; no treatment and no changes are planned during the study. * patient who are participating in other clinical trials at the screening * females who are pregnant, breastfeeding, or planning a pregnancy during the study period, or female of childbearing potential, not using a reliable means of contraception. * patients who are not eligible for this study at the discretion of the investigator.
treatment of symptoms in male patients with lower urinary tract symptoms (luts) predominant storage symptoms (overactive bladder syndrome)

Conditions: Lower Urinary Tract Predominant Storage Symptoms

Summary: this study is a non interventional study where no investigational medicine is provided. procedures and examination will follow the institution standard of care practice. the therapeutic approach will not be decided in advance by the protocol or influenced in any way by the protocol. after standard evaluation the investigator will decide the treatment strategy and upon eligibility criteria met will propose subject to participate to the study. informed consent will be collected for all subjects. the study will consist of 3 possible observational visits; v1 (enrolment), v2 and v3 (follow up). during all observational visits (v1, v2 and v3) the patient will complete the i-pss (international prostate symptom score) questionnaire including quality of life (qol) questionnaire and a patient assessment of treatment benefit and satisfaction using a visual analogue scale (vas). the patient will be asked to complete a voiding diary the first 3 days after visit 1 (baseline diary), 3 days before visit 2 and again 3 days before visit 3. prostate specific antigen (psa) measurement- uroflowmetry - post voiding residual volume and trans rectal ultra sound data will be collected only if available. during all observational visits (v1, v2 and v3) the investigator will complete the assessment of treatment benefit and satisfaction using a vas.


Eligibility criteria:
inclusion criteria: the following subjects can be included in this study if they answer the following criteria: * they have been prescribed solifenacin 5-10mg according to summary of product characteristics (smpc). * subjects with diagnosed lower urinary tract symptoms (luts) with substantial storage disorder defined as urgency, and/or frequency and/or urge urinary incontinence (uui) at the discretion of the investigator. * ipss storage sub-score \> 8 * subject expected to require at least 3 months treatment with solifenacin. exclusion criteria: * any reason which following current medical knowledge, physical condition of the patient and in the opinion of the investigator contraindicates administration of solifenacin to the subject, such as- signs and symptoms suggestive of urinary tract infection (confirmed by positive urine analysis). * history of bladder obstruction not being adequately corrected. * anticipate or plan to participate in another study during study period of 12 weeks from study entry.

Keywords: observational non-interventional prospective phase iv treatment overactive bladder syndrome solifenacin
low-dose aspirin in in vitro fertilization (ivf) and intracytoplasmic sperm injection (icsi) treatments

Conditions: Pregnancy; Miscarriage Less Than 12 Gestational Weeks; Extrauterine Pregnancy; Preeclampsia; Intrauterine Fetal Growth Restriction

Summary: in this study we hypothesized that low-dose aspirin therapy (100 mg daily) improves ovarian responsiveness, uterine haemodynamics and clinical pregnancy rates in unselected subjects undergoing ivf/icsi when the treatment is started concomitantly with controlled ovarian hyperstimulation.

low-dose acetylsalicylic acid irreversibly inhibits the cyclo-oxygenase enzyme in platelets, thus preventing the synthesis of thromboxane, which causes vasoconstriction and platelet aggregation. by this mechanism low-dose aspirin may enhance ovarian and uterine blood flow and tissue perfusion and thus improve ovarian responsiveness for gonadotrophins and endometrial receptivity for implantation. randomized controlled studies and meta-analyses on the low-dose aspirin therapy to improve ivf/icsi outcome or uterine hemodynamics have revealed conflicting results.

Eligibility criteria:
inclusion criteria: * age \< 40 years * \< 4 previous ovarian stimulations exclusion criteria: * allergy for acetylsalicylic acid

Keywords: assisted reproduction ovarian response uteroplacental hemodynamics doppler ultrasonography implantation rate pregnancy rate live birth rate
un-blinded data collection study of concussion using the brainpulse(tm)

Conditions: Mild Traumatic Brain Injury

Summary: the primary objective of this study is to collect un-blinded brainpulse recordings from youth and adults that have a confirmed diagnosis of concussion per protocol guidelines in order to improve a concussion detection algorithm previously developed by jan medical, inc. subjects will be followed for 21 days after the initial injury with brainpulse recordings to study the subject's recovery process. the symptomatic evaluation, physical examination, and brainpulse recordings will be entered in a database to assess clinical outcome and device utilization.brainpulse(tm)

jan medical is conducting a data collection study with the goal of developing further insight into understanding the signal features within a brainpulse recording that are only present when the subject has a confirmed concussion. the initial pilot blinded study with stanford university showed that there is increased energy in the 8-15 hz range for brainpulse recordings from adolescent male football players with a confirmed concussion. the current un-blinded study is designed to record the brainpulse signal from a more diverse subject population to represent patients who have been diagnosed with a concussion in clinic setting. subjects will include males and females ages 13 and older.

Eligibility criteria:
inclusion criteria: 1. age \> 13 years old and not part of any other vulnerable population such as pregnant women. 2. suspected or confirmed concussion by medical professional 3. not more than 3 days since injury/trauma event 4. willing and able to participate in all required study evaluations and allow access to medical testing and records 5. signed informed consent/assent, and/or have a legally authorized representative willing to provide informed consent on behalf of the subject. 6. demonstrates a minimum of 3 of the following symptoms: * headache * pressure in head * dizziness * neck pain * fatigue/ low energy * nausea or vomiting * irritability * difficulty in concentrating/performing tasks * memory impairment * insomnia * reduced tolerance to stress * sensitivity to light * difficulty balancing * blurred vision * confusion * more emotional than usual * sadness * nervous/anxious * vacant stare * delayed verbal/motor response * 'feeling like in a fog' * 'don't feel right' exclusion criteria: 1. wound or open laceration on the head in the area of one of the brainpulse sensors that would impede use of the brainpulse device 2. any serious medical condition that in the opinion of the medical professional would impair ability to provide informed consent/assent or otherwise disqualify a patient from participation 3. currently participating in or planning to participate in another clinical study during the course of the current clinical study. 4. implantation of any medical device in head (e.g. ventriculoperitoneal shunt) 5. an alternative diagnosis is made other than concussion

Keywords: concussion
internet-delivered cognitive behavior therapy (cbt) for children age 8-12 years with anxiety disorders

Conditions: Anxiety Disorders

Summary: the purpose of this study is to investigate whether a 10 week internet-delivered cbt is a feasible approach to treat children (age 8-12 years) with anxiety disorder (social phobia, panic disorder, specific phobia, generalized anxiety disorder or separation anxiety disorder). the program is directed toward both the parents and children. the patients work with the treatment is supported through on-line contact with a therapist. approximately 128 patients will be included in the study and randomized to either condition. all included patients are assessed before the treatment starts and after 10 weeks (post treatment). follow-up assessments are conducted at 3 and 12 months after treatment.


Eligibility criteria:
inclusion criteria: * primary diagnosis of social phobia, panic disorder, specific phobia, generalized anxiety disorder or separation anxiety disorder, * age between 8 and 12 years, * ability to read and write swedish and * with access to a computer and use of internet. exclusion criteria: * presence of neuropsychiatric diagnosis or a primary psychiatric disorder other than those that the treatment aims at.

Keywords: cognitive behavior therapy internet anxiety disorders children