Kornimate/medical-research-clean huggingface dataset:
kinematic assessment in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: multiple sclerosis (ms) affects more than a 120,000 people in the united kingdom and is the commonest neurological condition in young adults. ms causes a number of symptoms including weakness, altered sensation, pain and memory difficulties. there are different forms of ms, including relapsing-remitting ms (rrms), primary progressive ms (ppms) and secondary progressive ms (spms). currently there are several effective treatments for rrms, but no nice approved treatment for spms. patients with ppms and spms experience a gradual progression in disability that affects individual patients differently. a number of clinical scores are used to quantify the disability in individual patients and some of these scores focus on the patients' lower limb function. in the progressive forms of ms, preservation of upper limb function becomes a more important concern for patients to maintain their quality of life. with the advent of new treatment trials for ppms and spms, it is important that clinicians and researchers are able to use accurate and quantifiable measures of upper limb function to evaluate any changes with time or response to treatment. the use of motion tracking software provides a unique opportunity to accurately track movements in real time and space and give a tailored assessment of an individual's function. the overall aim of this study is to use established kinematic assessment tools to explore the extent and progression of upper limb dysfunction in patients with progressive ms. this aim will be achieved via the following objectives: * recruit a sample of participants with ppms and spms from the local ms population * quantify the physical impairment in these participants using existing clinical scores as well the kinematic assessment tools that have been developed * follow-up the participants for a period of 12 months to identify and quantify any progression in their upper limb dysfunction * identify any factors that may influence upper limb dysfunction in this group * develop and evaluate the role of further kinematic techniques in this group of participants


Eligibility criteria:
inclusion criteria: * age above 18 years at the time of enrolment into the study * participants with a confirmed diagnosis of ms that have entered the primary or secondary progressive stage for at least 12 months * participants must be able to comply with the terms and methods of the protocol * study specific written informed consent has been obtained exclusion criteria: * age below 18 years at the time of enrolment into the study * participants with a diagnosis of rrms * participants unable to comply with the terms or methods of the protocol * participants who report any cognitive or memory impairment * participants with significant co-morbidities that affect their upper limb function i.e. stroke etc.

Keywords: upper limb function kinematic assessment
crf2 agonist for the treatment of worsening heart failure

Conditions: Worsening Heart Failure

Summary: this study assesses the effects of the investigational drug cor-1167 in subjects hospitalised due to worsening of heart failure (hf)

this is a phase 2b, randomized, double-blind, placebo-controlled study designed to assess the dose-dependent effects of 3 doses of the corticotropin-releasing factor type 2 (crf2) peptide agonist, cor-1167, in subjects with whf, defined as subjects requiring urgent administration of intravenous (i.v.) diuretics due to worsening of signs and symptoms of heart failure (hf) associated with volume overload

Eligibility criteria:
inclusion criteria: * signed written informed consent * heart failure hospitalization (hfh) during previous 12 months * prescribed an oral loop diuretic for at least 1 month preceding the index event * nt-probnp ≥1,000 pg/ml or bnp ≥250 pg/ml * requires treatment with i.v. diuretics for volume overload * at least 1 risk factor for diuretic resistance * admitted to the hospital not more than 48 hours prior to randomization exclusion criteria: * index event primarily triggered by an acute event (e.g. ami, pe, arrhythmia) * requirement for i.v. inotropic therapy or i.v. vasodilators, mechanical ventilation, high-flow oxygen therapy, or niv * requirement for, or planned use of lvads, iabp, or any type of mcs * history of solid organ transplant or active on a transplant list * sbp \<100 mmhg * egfr \< 20 ml/min/1.73 m2 * cabg, pci, implantation of crt, heart valve procedure or any cardiac surgery within 1 month prior to screening or planned during the study * severe stenotic cardiac valvular disease * severe chronic pulmonary disease requiring chronic steroid therapy or chronic oxygen therapy (\> 2 l/min) * uncorrected severe hyperthyroidism or hypothyroidism * severe restrictive, obstructive, or infiltrative cardiomyopathy * body weight \< 70 kg * use of any investigational drug(s) within 5 half-lives of screening * at high risk of death (defined as life expectancy ≤1 year) from causes other than heart failure or any disease that, in the opinion of the investigator, will preclude their safe participation in this study, and will make implementation of the protocol or interpretation of the study results difficult * presence of any other conditions (e.g. geographic, social) actual or anticipated, that the investigator feels would restrict or limit the subject's participation or compliance with all study procedures subject is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study

Keywords: cor-1167 hospitalised heart failure whf
cardiac arrest and intra osseous infusion

Conditions: Cardiac Arrest

Summary: the international recommendations don't explain the place of the intraosseous infusion in the reanimation of adult cardiac arrest; the goal of this preliminary study is to inform the delay for obtaining a vascular access by evaluation of a current strategy (using intraosseous infusion after one peripheral venous access failure) and to determine the potential failure risk factors of venous access.

in 2010, the european resuscitation council and the international liaison commitee on resuscitation have made new recommendations about management of cardiac arrest. the intraosseous infusion was described as an alternative to the peripheral venous access, before the intra tracheal way for adrenaline administration. but this work doesn't specify the delay and the circumstance for this use: time to obtain a vascular access, number of failure, difficulty to obtain a venous access. furthermore the recent improvements in intraosseous devices may make it relevant to compare intra osseous infusion and venous access in first intention in adult's cardiac arrest in view of the significant number of venous failures and of the subsequent delay of adrenaline administration. the goal of this preliminary study is to inform the delay to obtain a vascular access by evaluation of a current care (using intravenous infusion after one peripheral venous access failure) and to determine the potential failure's risk factors of venous access. main objective: estimate the delay to obtain an effective vascular access (peripheral venous access, intra osseous infusion, central venous access) in resuscitation of adult's cardiac arrest by out of hospital care unit according to the international recommendations. study design: monocentric prospective cohort of consecutive patients presenting with out-of-hospital cardiac arrest.

Eligibility criteria:
inclusion criteria: * 18 years old or over * patients insured by social security * cardiac arrest (all causes) with mobilisation of a intensive mobile care unit in primary intervention * medical resuscitation indicated exclusion criteria: * pregnancy * contraindication osseous infusion

Keywords: cardiac arrest peripheral venous access intraosseous access
prenatal dex study

Conditions: Congenital Adrenal Hyperplasia

Summary: the classic form of 21-hydroxylase deficiency (prevalence 1/15,000) is the most common cause of congenital adrenal hyperplasia (cah). this autosomic recessive disease is responsible for virilization of the external genitalia in girls through androgen hypersecretion during fetal life. since 1984, the lyon pediatric endocrinology group has proposed prenatal dexamethasone (dex) for all fetuses at risk of cah with the aim of preventing fetal androgen hypersecretion in affected girls and avoiding poor long-term results from reconstructive surgery. prenatal dex was used in europe and the usa but its use was recently suspended: in 2007, a swedish study conducted on 26 children treated with dex in utero for a short period of time reported cognitive impairments. these data were not confirmed by an american study on the short-term dex use, which showed potential cognitive impairments in cah children exposed to dex for long periods of time. these confusing and controversial results have caused the scientific community to question its position and have resulted in the suspension of the use of prenatal dex with drastic consequences for cah girls (virilization; genital surgery etc.). in this context, an evaluation of neuropsychological development under in utero dex is essential to validate its indication for use during the prenatal period. this study will evaluate outcomes using prospective cognitive and emotional assessments. it will first focus on the unaffected children previously treated in utero in order to assess the adverse effects of the drug. the study will then assess the children with cah for whom dex could have beneficial effects.


Eligibility criteria:
inclusion criteria: groups d+1, d+2, d-1 and d-2 * male or female * patient with congenital adrenal hyperplasia or sibling of a cah patient * age: 6 to 15 years (at the time of inclusion) * the subject's legal representatives have understood the information note/informed consent form, obtained answers to all their questions and have given signed, written, informed consent * subject with health insurance group d-3 (schoolchildren) * male or female * with no connection with congenital adrenal hyperplasia * age: 6 to 15 years (at the time of inclusion) * the subject's legal representatives have understood the information note/informed consent form, obtained answers to all their questions and have given signed, written, informed consent * subject with health insurance exclusion criteria: for all groups : * patient/subject with another genetic disease * patient/subject with known neuropsychology disease(s) * patient/subject whose mother has received another treatment during her pregnancy with possible known adverse events on the neuropsychological development of the child

Keywords: congenital adrenal hyperplasia prenatal treatment dexamethasone neuropsychological assessment cognitive development
effects of blood pressure reduction on high sensitivity c-reactive protein (hscrp)

Conditions: Hypertension

Summary: the study compares the efficacy of an aggressive versus a moderate initial antihypertensive regimen to reduce blood pressure in patients with stage 2 hypertension. additionally, the study examines the effects of blood pressure reduction on the levels of high sensitivity hscrp. although the main goal is to determine the overall effect of blood pressure reduction on hscrp levels, analysis will also evaluate whether an aggressive antihypertensive regimen is more effective than a moderate one in reducing hscrp levels.


Eligibility criteria:
inclusion criteria: 1. stage 2 hypertension as defined by the mean of three (3) repeated seated bp measurements of: sbp of 160 to 185 mmhg, inclusive and/or dbp of 100 to 109 mmhg, inclusive. 2. patients must have documentation of serum creatinine equal or \ 3.5 and equal or \<5.5 mmol/l, and serum ast or alt \<2xuln obtained within 3 months prior to visit 1. 3. patients must have documentation of hba1c equal or \<11.0 % obtained within 1 month prior to visit 1. exclusion criteria: 1. history of secondary hypertension. 2. pharmacologic antihypertensive therapy with ace inhibitors, angiotensin receptor blockers, or aldosterone blockers within 3 months prior to visit 1, or with thiazide diuretics within 1 month prior to visit 1. the use of other classes of agents which lower bp but are being used for other therapy or for htn, are allowed as long as these agents are started at least 3 months prior to randomization, are not initiated after enrollment and doses remain unchanged during the study. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: hypertension (htn) high sensitivity c-reactive protein
comparison of contrast-enhanced spectral mammography (cesm) to mri in screening high risk women for breast cancer

Conditions: Breast Cancer

Summary: this research study is comparing dual-energy contrast-enhanced spectral mammography (cesm) to mri as a screening tool for breast cancer.

this research study is being done to test how well a contrast enhanced mammogram compares to mri in screening for breast cancer in people who are at higher risk for developing breast cancer. standard screening mammograms can miss breast cancers due to its inability to "see through" dense breast tissue. for this reason, women at increased risk for the development of breast cancer often undergo additional screening beyond conventional mammography with magnetic resonance imaging (mri). although screening mri is very sensitive for finding breast cancer, it also finds many areas that are benign (not cancer). the only way to know which is the cancer is to perform a biopsy, which contributes to patient anxiety and leads to many unnecessary biopsies. in the preliminary studies performed in women already diagnosed with breast cancer, contrast enhanced mammography was shown to have a similar sensitivity for finding primary breast cancer but detected fewer of the benign findings which would result in fewer unnecessary biopsies. it is also a faster and less expensive exam compared to mri. contrast mammography was fda approved in 2011 and is used now as a tool to help work-up abnormalities seen on standard mammography and ultrasound. we are now studying to see if contrast enhanced mammography will also be a beneficial tool in the screening setting to screen high risk patients for breast cancer.

Eligibility criteria:
inclusion criteria: * women * age \> or equal to 30 years * high risk (\>20% lifetime risk) * has a bilateral mammogram within the last 7 months * has had a same day high risk screening mri exclusion criteria: * participants who have a known allergy or contraindication to iodinated contrast. * participants who have a known allergy to food or medications. * participants who have renal insufficiency or failure. * participants who are pregnant or breastfeeding. * participants with a concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia.

Keywords: breast cancer
laparoscopic guided transversus abdominis plane block for postoperative analgesia after pediatric laparoscopic surgery.

Conditions: Analgesia

Summary: the aim of this study will be to investigate the safety and analgesic efficacy of transversus abdominis plane (tab) block versus psoas block blockade. both blocks will be administered surgically and guided by the laparoscopy screen in children undergoing laparoscopic surgery.

transversus abdominis plane (tap) block is a promising effective method for postoperative pain control after major abdominal surgery. tap block provides analgesia by inhibiting nerve conduction from the anterior abdominal wall arising from the intercostal nerves, subcostal nerves, and first lumbar nerve (t6-l1). using a landmark technique, it is easily performed, but its popularity has decreased because of reduced efficacy due to inaccurate injection and the potential for intra-peritoneal organ damage. ultrasound-guided tap block provides better results and fewer complications, but it requires experienced operators. surgically administered tap (stap) block guided by the video camera of the laparoscope is a simple technique and may cause no complications. also, under laparoscopic guidance, block of ilioinguinal, iliohypogastric, and genitofemoral nerves can be possible with anesthetic injection in the plane between psoas major and the fasciae covering its anterior aspects \[laparoscopic-assisted psoas (lap) blockade\].

Eligibility criteria:
inclusion criteria: * children (1-6 years) of both sexes undergoing elective laparoscopic surgeries that last \>30minutes (eg. undescended testis and inguinal hernia repair). * written consent, free and informed exclusion criteria: * significant respiratory, cardiac or renal disease * bmi \>95th percentile for age.
assessment of three basic progressive lens designs

Conditions: Presbyopia

Summary: this clinical trial investigates the differences between three different progressive addition lens designs. it is a non-invasive double-masked randomized clinical investigation. for this study, 80 participants will be recruited.

the purpose of the study is to evaluate the preference, adaptability, and visual performance of three progressive lens designs. the difference in these lens designs is a variation of zone sizes for intermediate and near vision. the clinical trial helps manufacturers and eye care practitioners to give detailed suggestions to patients. study participants will be experienced progressive addition lens wearers, which will be recruited by advertisements, by email, and with direct person-to-person solicitation. the study will be conducted at the eye care institute at the patient care center western university of health sciences, pomona, ca, 91766. for each participant, the study is completed in around two months and requires three separate visits.

Eligibility criteria:
inclusion criteria: * age: 45 to 70 years old. * visual acuity: far \& near monocular: cc ≥ 20/20 (decimal cc ≥ 1.0) * normal binocular vision (at distance \& near: no strabismus on cover testing, aligning prism of less than 2δ horizontally or vertically, stereoacuity of 2' or better at distance and near). * prescription is in the range: * spherical power: less than +/-6.00 d * cylindrical power: less than -2.75 d * addition: 1.50 d - 2.50 d * difference in power (spherical equivalent) between eyes: less than 2.00 d exclusion criteria: * have never worn any progressive lens design. * first prescription for progressive lenses. * prescription found during visit#1 varies from current prescription more than 0.50 d in any meridian. * currently wearing single vision lenses with accommodative support. * double vision or prismatic prescription in current glasses. * known ocular disease including strabismus, any pathology, any eye surgeries that may affect visual acuity. * use of systemic or ocular medications that are likely to affect vision. * balance problem/vertigo problem. * concurrent participation in other vision-related research.
alk21-003ext: an extension of study alk21-003 (nct01218958) to test the long-term safety of medisorb® naltrexone (vivitrol®)

Conditions: Alcohol Dependence

Summary: this was a phase 3 multicenter extension of alkermes' study alk21-003 (nct01218958 \[the base study\]) that evaluated the safety of medisorb® naltrexone (vivitrol®) administered every 4 weeks for 48 weeks (13 injections) in alcohol-dependent adults who had completed study alk21-003.

all participants in this study received medisorb naltrexone at double-blinded dose strengths (ie, 190 mg or 380 mg); no participant received placebo. participants who had received medisorb naltrexone in study alk21-003 (nct01218958) continued to receive the same dose strength in this extension study. those who had received placebo for medisorb naltrexone 190 mg in the base study were given medisorb naltrexone 190 mg. participants who had received placebo for medisorb naltrexone 380 mg in the base study were given medisorb naltrexone 380 mg. neither the identity or dose of the treatment received in the base study, nor the medisorb naltrexone dose strength (190 mg or 380 mg) received in this extension were revealed to any participant, the investigator, or any blinded member of the clinical study team during the conduct of the base study or this extension. all participants were encouraged to receive standardized biopsychosocial support at each clinic visit throughout the study; however, unlike the base study, participation was not mandatory. participants eligible for this extension study had received all 6 injections of study drug in the base study; those who received medisorb naltrexone in the base study who also received all 13 injections in this extension therefore had a duration of exposure of approximately 76 weeks (\~1.5 years) upon completion of this extension. for participants who had received placebo in the base study, maximum duration of exposure was approx. 48 weeks (1 year).

Eligibility criteria:
primary inclusion criteria: * completed study drug treatment in study alk21-003 (base study \[nct01218958\]) * written informed consent for this extension study * stable address and telephone; reconfirmation of contact's address and phone * women with childbearing potential must agree to continue to use an approved method of birth control throughout study participation primary exclusion criteria: * positive urine drug screen for opioids at visit 1 * early termination of study drug in the base study * pregnancy or lactation

Keywords: alcohol dependence
cbt in patients with medication overuse headache

Conditions: Medication Overuse Headache

Summary: according to the definition from international headache society, medication overuse headache (moh) is diagnosed when patients takes painkillers for more than 10 or 15 days per month (depending on what kind of painkillers being used), for more than 3 months, which results in the deterioration of headache. the treatments of moh include preventive medication of headache and withdrawal of the overused painkillers. other than the simple oral advice, some researchers recommended non-pharmacological methods. pryse-phillips et al. (1998) reviewed the the treatment of migraine and suggested that biofeedback, relaxation, cognitive behavior therapy (cbt), psychological therapy, hypnosis and physical treatment are effective. researches also point out cbt is effective on withdrawing medication in patients with moh (kroner-herwig, 2009). lake (2006) reported that behavioural therapy maybe an adjunct therapy to preventive medication to reduce the relapse rate of medication overuse. the purpose of this study is to confirm the effect of cbt in patients with moh. the target is to reduce the frequency of headache and use of painkillers. patients could benefit from the education and relaxation training during cbt to cope with headache and reduce the use of painkillers. the research will recruit 60 patients with moh at neurology clinics, far eastern memorial hospital. they will be separated into two groups, 30 in control group and the other 30 in the experimental group. education of moh, relaxation and cognitive restructuring would be included in the four weeks training program. the training program is under the supervision of a neurologist from far eastern memorial hospital and a psychology professor from fu jen catholic university. the control group will accept four weeks telephone interview to confirm their headache diary including the frequency of headache and use of painkillers. the frequency of headache and medication use will be used for analyzing the effect of cbt.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of medication overuse headache exclusion criteria: * other type headache

Keywords: medication overuse headache