Kornimate/medical-research-clean huggingface dataset:
objective study in rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: primary objectives 1. to test the feasibility, in patients with active rheumatoid arthritis, of using an 'aggressive' treatment algorithm to bring a short term treatment objective (sto) within the normal or an arbitrarily defined 'desirable' range. 2. to determine whether patients with active rheumatoid arthritis randomly allocated to a particular sto show a reduced rate of magnetic resonance imaging damage progression at two years compared to those randomly allocated to usual care. secondary objectives 1. to establish the relationship between achieving a given sto or combination of stos and damage progression. 2. to identify the characteristics of responders and non-responders with respect to sto achievement and predictors of greater and lesser degrees of damage progression.


Eligibility criteria:
inclusion criteria: * rheumatoid arthritis as defined by the american college of rhemuatology criteria and either * active disease: ≥6/28 swollen joints or * erythrocyte sedimantation or c-reactive protein \> normal * disease duration ≤ 15 yrs * any therapy * females of child-bearing potential must be adequate contraception exclusion criteria: * frailty, limiting co-morbidity * obesity limiting ability to have mri * geographical difficulty preventing follow-up and visits * women at risk of becoming pregnant the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
comparative study of the loading dose administrated via epidural needle or epidural catheter for labor analgesia

Conditions: Labor Pain

Summary: epidural anesthesia (ep) is widely used for labor analgesia. time to onset of adequate pain relief of ep technique for labor analgesia may be 15 to 20 minutes.more rapid injection is often passible through the needle compared to catheter and could enhance the spread of medication within the epidural space.there is lack of research assessing the onset of labor analgesia with a large priming dose of local anesthetic through the epidural needle compared with the epidural catheter.

the epidural analgesia was performed in the left lateral decubitus position at the l3-l4 or l2-l3 interspace using a 18 g tuohy needle. the epidural space was accessed by the loss of resistance to air or saline (2ml or less) technique. in the epidural needle group, after identification of epidural space, a dose of 3 ml of 0.1%ropivacaine with 0.3ug/ml sufentanil was given via the epidural needle ,3 minutes later labor analgesia was initiated with 15ml of 0.1 ropivacaine with 0.3ug/ml sufentanil over 30 seconds via the epidural needle, and then the catheter was inserted 3-5cm into the epidural space. in the epidural catheter group, the catheter was inserted 3-5cm into the epidural space after identification of epidural space, a dose of 3 ml of 0.1% ropivacaine with 0.3ug/ml sufentanil was given via the epidural catheter, 3minutes later labor analgesia was initiated with 15ml of 0.1%ropivacaine with 0.3ug/ml sufentanil as the same of group n.

Eligibility criteria:
inclusion criteria: 1. healthy, term (37-42 weeks' gestation), 2. nulliparous women with singleton 3. patients in active labor with a cervical dilation \<5cm who planned labor analgesia exclusion criteria: 1. any contraindication to neuraxial anesthesia, 2. body mass index\>50kg/m2, 3. vas \<50mm on a 100-mm visual analog pain scales during an active contraction, 4. pregnancy-related diseases (ie, gestational hypertension, gestational diabetes, and preeclampsia), 5. the participants were in the event of an inadvertent dural puncture using the epidural needle, 6.fetal heart abnormity before labor analgesia.
using telehealth to address alcohol misuse in hiv care

Conditions: Alcohol Drinking; HIV Viremia

Summary: this project will test the effects of a telehealth counseling program on reducing alcohol use and improving hiv viral control among people with hiv who drink heavily. in total, 600 heavy drinkers with hiv will be assigned to either (a) a single session of brief counseling on alcohol use or (b) brief counseling plus referral to a telehealth counseling program that includes multiple sessions of counseling by videoconferencing and text messaging support. to understand the effects of the program, participants' alcohol use, hiv outcomes, and health will be assessed over a 2-year period.

the purpose of the proposed study is to test the real-world effectiveness of the reach (reducing alcohol use and related comorbidities in hiv care) telehealth counseling protocol in a pragmatic hybrid type 1 effectiveness-implementation randomized trial. the study will recruit 600 heavy-drinking plwh from four federally-qualified health centers in geographically distinct regions across the u.s, which provide services to over 14,000 plwh. upon completing enrollment, participants will be randomized to receive either single-session brief intervention (bi) by phone with referral to local treatment when appropriate or bi plus referral to reach telehealth counseling (tc). participants will complete follow-ups through 24 months after baseline to assess longer-term changes in drinking and health outcomes. the study will test the hypothesis that tc compared to bi will result in (a) reduced number of drinks consumed per week and frequency of heavy drinking and (b) increased odds of having an undetectable viral load at 12- and 24-month follow-ups. secondary outcomes include self-reported art adherence, engagement in condomless sex with non-exclusive partners, frequency of other substance use, phosphatidylethanol levels (a biomarker of recent alcohol use), and veterans aging cohort study index scores. the study also will examine potential moderators of tc effectiveness. as a secondary aim, implementation measures corresponding to aspects of the dynamic sustainability framework will be assessed including implementation outcomes of acceptability, appropriateness, and feasibility guided by proctor's implementation outcomes framework. thus, this pragmatic hybrid type 1 trial will help establish the real-world effectiveness of the reach tc intervention while also providing key implementation-related measures and outcomes that will inform future reach tc scale up and sustainability.

Eligibility criteria:
inclusion criteria: * in care for hiv at one of 4 participating federally qualified health centers, report at least one heavy drinking day (4+ drinks) or average more than 7 drinks per week in the past 30 days exclusion criteria: * need for supervised alcohol detoxification, as indicated by having a history of severe withdrawal symptoms such as seizures and delirium tremens.
to evaluate safety and effectiveness of rovatitantab.

Conditions: Hypertension; Hyperlipidemias

Summary: to evaluate the safety and effectiveness of a fixed-dose combination containing valsartan and rosuvastatin (rovatitan® tablet) in patient with hypertension and hypercholesterolemia

* effectiveness: the ratio of patients who reach target bp or ldl-cholesterol * safety: we will collect safety data

Eligibility criteria:
inclusion criteria: * patients who have hypertension and hyperlipidemia and older than 19 years * patients who undertstand purpose and method of study, agree with study exclusion criteria: * patients who have been administered rosuvastatin/valsartan as a anti- hyperlipiddemic/anti-hypertensive drugs * uncontrolled hypertension (sbp\>=180mmhg or dbp\>=110mmhg) * patients who participated another clinical study or observational study 3 months ago.
phase 1 safety, pharmacokinetics and pharmacodynamics study of recombinant factor viia variant (813d) in adult subjects with hemophilia

Conditions: Hemophilia A

Summary: this study hypothesizes that the study drug, pf-05280602 (at the selected doses) will be safe to administer to subjects with severe hemophilia a or b with or without inhibitors and will demonstrate evidence of hemostatic activity. this is supported by the preclinical findings in hemophilic animal models.


Eligibility criteria:
inclusion criteria: * male subjects 18 to \<65 years old with severe hemophilia a or b with or without inhibitors to fviii or fix. * subjects is willing and able to comply with the mandatory washout periods prior to screening and prior to dosing and through 48 hours post dosing. at screening this includes a washout of fix for 96 hours and fviii for 72 houts. at dosing this includes a washout of fix for 96 hours and fviii and other hemostatic agents for 72 hours through 48 hours post dosing. * subjects must agree and commit to using a a highly effective method of birth control from the time of screening through four weeks after study drug administration. exclusion criteria: * presence of a bleeding disorder in addition to hemophilia a or b. * regular, concomitant therapy with immunomodulating drugs (eg, intravenous immunoglobulin, and routine systemic corticosteroids). * history of coronary artery disease, thrombolic disease or diagnosis of prothrombic disorder.

Keywords: phase 1 safety pharmacokinetic pharmacodynamic
a study to evaluate efficacy and safety of povorcitinib in participants with nonsegmental vitiligo (stop-v2)

Conditions: NonSegmental Vitiligo

Summary: this study is being conducted to determine the efficacy and safety of povorcitinib in participants with nonsegmental vitiligo.


Eligibility criteria:
inclusion criteria: * aged ≥ 18 years. * clinical diagnosis of nonsegmental vitiligo and meet the following: * t-bsa ≥ 5% * t-vasi score ≥ 4 * f-bsa ≥ 0.5% * f-vasi score ≥ 0.5 * agreement to discontinue all agents and procedures used to treat vitiligo from screening through the final safety follow-up visit. * willingness to avoid pregnancy or fathering children. exclusion criteria: * other forms of vitiligo or skin depigmentation disorders. * clinically significant abnormal tsh or free t4 at screening. * use of laser or phototherapy within 8 weeks and dihydroxyacetone within 4 weeks prior to day 1. * current or past use of the depigmenting agent monobenzyl ether of hydroquinone including benoquin®. * history of melanocyte-keratinocyte transplantation procedure or other surgical treatment for vitiligo. * spontaneous and significant repigmentation within 6 months prior to screening. * women who are pregnant, considering pregnancy, or breast feeding. * medical history including thrombocytopenia, coagulopathy or platelet dysfunction; venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, stroke, moderate to severe heart failure, cerebrovascular accident, myocardial infarction, or other significant cardiovascular diseases; q-wave interval abnormalities; disseminated herpes zoster or recurrent dermatomal herpes zoster; disseminated herpes simplex; chronic/recurrent infections; malignancies. * evidence of infection with tb, hbv, hcv or hiv. * history of failure to jak inhibitor treatment of any inflammatory disease. * laboratory values outside of the protocol-defined ranges. other protocol-defined inclusion/exclusion criteria may apply.
seniors guardian: a monitoring platform for the elderly

Conditions: Quality of Life

Summary: this pilot study evaluates whether a telemonitoring platform of activities of daily living amongst the elderly can improve their quality of life. participants will be randomised to two different follow-up strategies, one comprising a monitoring platform and the other standard visits at a healthcare facility. quality of life will be assessed using standardised questionnaires.

elderly participants at perceived socioeconomic risk will be randomised in a 1:1 ratio to receive either a telemonitoring platform in their houses or standard health care. the platform will include sensors able to detect falls, nocturia (which have been previously validated) and sensors for environmental variables including humidity, carbon monoxide levels and temperature. in addition, a wearable panic button will be provided for participants allocated to the sensor platform which will allow them to obtain help in case of an emergency. the sensor platform will be connected to emergency services and healthcare providers,and they should receive and react to any anomaly detected in their readings. participants will be followed up for 10 months. quality of life questionnaires, including the world health organisation's whoqol-bref and the eq-5d for health-related quality of life, will be used to address potential intervention effects.

Eligibility criteria:
inclusion criteria: * elderly participant (\>65 years of age) perceived to be at socioeconomic risk * resident in the city of valparaiso or san antonio * lives alone * obtained a housing subsidy from the servicio de vivienda y urbanismo (housing and urbanism services) exclusion criteria: * dementia * substance or alcohol abuse * inability to answer quality of life questionnaires due to medical or psychiatric morbidity * terminal illness (life expectancy under 6 months) * ownership of pets within the residence (ie. dogs, cats). * refusal to participate

Keywords: elderly activities of daily living telemonitoring
post-endoscopic infection rate notifications to improve the delivery of care

Conditions: Infection

Summary: this project will notify centers of center's post-endoscopic infection rates and evaluate the effectiveness of this notification system to decrease infection rates. the investigators aim to notify centers of the number of patients and center's risk-adjusted rates of hospitalizations for infections after colonoscopy and esophagogastroduodenoscopy (egd) procedures performed between january 2015 and september 2018. the investigators will randomize centers to two notification groups: (1) ability to view center's rate compared with all other centers (ascs and outpatient centers notified and compared separately) or (2) ability to view center's rate compared with the other centers with a similar patient comorbidity profile and in addition to viewing option 1. facilities will answer questions about center's infection control practices. the investigators hypothesize that centers with high rates of post-procedural infections will (1) be more likely to report that the center took action to investigate the center's infection control practices after the first notification and (2) observe a decrease in infections after the notification. the investigators anticipate that centers with high rates of post-procedural infections that are randomized to group 2 will have greater change. the investigators anticipate no change in rates of infection in the facilities that had zero or very low (n=1) event rates.


Eligibility criteria:
inclusion criteria: * facilities that bill to fee for service medicare for gastrointestinal endoscopy exclusion criteria: -

Keywords: colonoscopy egd endoscopy asc outpatient infection endoscopic procedures
mulligan mobilization with movement method in the treatment of shoulder problems

Conditions: Shoulder Syndrome; Pain

Summary: to determine whether mulligan mobilization with movement (mwm) and conservative treatment ct give different results on pain, rom, and functional activities in participants with shoulder problems.

shoulder problems are one of the common orthopedic problems. patients with shoulder problems experience an increase in pain and a decrease in joint movement and functionality. with conventional treatment, patients' symptoms improve. however, the mwm is one of the manual therapy techniques frequently used to reduce pain in musculoskeletal system problems. it is extremely important to evaluate patients' functionality after rehabilitation. although there are studies comparing the effect of mwm in the literature, studies evaluating patient-specific functionality are also limited.

Eligibility criteria:
inclusion criteria: * being over 18 years old, * having any shoulder problems (impingement, rotator cuff syndrome, glenohumeral joint problems, etc.), * having a history of shoulder pain lasting at least 3 months, and volunteering to participate in the study. exclusion criteria: * having systemic or degenerative disease, a neurological disease, and * having more than one upper extremity pathology.
teach-back method on patient satisfaction and adherence to wound care regimen

Conditions: Keratinocyte Carcinoma

Summary: the purpose of this study is to examine a different way to educate patients about taking care of their wound and see how this method affects patient satisfaction, compliance to the wound care regimen, and patient experience. the teach-back method is delivered using the ask-tell-ask method. investigators will ask the patient about their knowledge of wound care healing, provide the patient educational component, then ask the patient to repeat what was said. if the answer is wrong or incomplete, the researcher will go over the information again with the patient to clear up any misunderstandings.

patients undergoing mohs micrographic surgery for skin cancers on the lower extremities for the first time that are left to heal by secondary intention are randomized either to receive a scripted teach-back session or a standard of care wound care education. this study wishes to compare wound care adherence, patient experience, wound complications, and the number of phone calls made by patients to the office between the two cohorts primary objective is to determine whether study participants who have received the teach-back method have an increase wound care adherence at one week post-operatively, compared to those who received the standard of care. to characterize differences in the patient experience between the two interventional groups 2 weeks after surgery. to determine whether the number of phone calls made post-operatively by patients will decrease in a 2 week follow-up time period. to characterize the differences in patient wound care adherence at 2 weeks after surgery. to determine whether there is a difference in complication incidence post-operatively

Eligibility criteria:
inclusion criteria: * presenting to outpatient mohs clinic at university department of dermatology, two chagrin highlands for the first time * have excision(s) from mohs micrographic surgery on the lower extremities that are left to heal by secondary intention * english-speaking exclusion criteria: * non-english speaking * a clinical diagnosis of mental, learning, and visual disabilities * a clinical diagnosis of dementia * those who have received mohs micrographic surgery before regardless of area

Keywords: mohs micrographic
brillant blue versus indocyanine green for macular hole surgery

Conditions: Idiopathic Macular Holes

Summary: macular hole surgery with two different dyes


Eligibility criteria:
inclusion criteria: * idiopathic stage 3 and 4 macular holes * stage 2 macular holes, followed up for at least 6 months * pseudophakic and phakic eyes * age over 60 years exclusion criteria: * traumatic macular holes * secondary macular holes * severe ocular diseases

Keywords: macular hole surgery membranepeeling closure rate vitreoretinal dyes
biology of juvenile myoclonic epilepsy

Conditions: Juvenile Myoclonic Epilepsy

Summary: the investigators are collecting genetic information through blood samples as well as clinical and eeg data from over 1000 people with juvenile myoclonic epilepsy (jme) across the uk, europe and north america. this study will draw on both existing and new samples from jme patients. these will be compared to anonymised data from samples for 2000 controls. the goal of this study is to find the genetic cause of jme. finding the cause will help create better treatments for jme, as well as improve patient outcomes by allowing us to detect it earlier.

epilepsy is a common neurological disorder affecting 1% of the population. there are over 30 types of epilepsy, some common, some rare. most epilepsies arise in childhood and have a genetic cause. approximately 40% of patients have the common forms of genetic generalised epilepsy (gge), and the commonest gge is "juvenile myoclonic epilepsy" or jme. the goal of this study is to find the genetic cause for jme. the investigators will do this by comparing the genetic code in jme patients with that in people who do not have epilepsy. this study will use clues from their electroencephalograph or brainwave test that is used to help diagnose epilepsy. participants will provide a single blood sample, along with permission to collect clinical data about their diagnosis and a copy of their clinical eeg. there is no direct benefit or risk to the research participants but the results from this study may help other people with epilepsy or brain impairments in the future. there is overwhelming evidence that jme is caused by changes in genetic code. these changes are likely to be found in more than just one gene and there may be more than one type of change. in order to find these changes, this study will look at a large number of people with jme and compare their genetic code with people who do not have epilepsy. finding the causes of jme will lead to better understanding of its cause, new treatments, and tailoring of treatments according to a person's genetic make-up.

Eligibility criteria:
inclusion criteria: * diagnosis of juvenile myoclonic epilepsy in accordance with consensus criteria * age of myoclonus onset 10-25 years * seizures comprising predominant or exclusive early morning myoclonus of upper extremities * eeg interictal generalized spikes and/or polyspike and waves with normal background * current age 10-40 years exclusion criteria: * myoclonus only associated with carbamazepine or lamotrigine therapy * eeg showing predominant focal interictal epileptiform discharges or abnormal background * any evidence of progressive or symptomatic myoclonus epilepsy or focal seizures * global learning disability * dysmorphic syndrome * unable to provide informed consent regrettably, we are currently unable to accept self-referrals to the biojume study.

Keywords: jme epilepsy juvenile myoclonic epilepsy genomewide association study genetics