Kornimate/medical-research-clean huggingface dataset:
motivational interviewing intervention for intimate partner violence

Conditions: Self-efficacy

Summary: this project is a randomized trial to determine if motivational interviewing (mi) is an effective intervention to help women in abusive intimate relationships. the study objective is to motivate abused women to identify and achieve their own specific goals that can help them address the violence in their lives. this project will be integrated into the setting of a busy family planning clinic in the mid-western united states, which serves a largely rural population. intimate partner violence (ipv) is screened using the women's experience with battering scale (web), a modified abuse assessment screen (aas), and the danger assessment screen (das). an expected 250 women who screen positive for ipv will be enrolled, randomized to the intervention or to usual care group, and complete the 6-month study protocol. all subjects complete a self-administered computer-based questionnaire at the initial and 6-month follow up visits to measure self-efficacy (primary outcome), stage of readiness to change, selected ipv-related health correlates (e.g., depression), and steps taken and resources used. the mi intervention is an "active listening" counseling technique aimed at guiding the patient towards identifying feasible, personalized goals and steps she can take to increase her self-efficacy and control in the relationship. the trained study interviewer will work with participants to identify steps they can safely take and local resources to help them meet their goals. the mi protocol consists of a face-to-face counseling session at baseline with follow-up telephone interviews conducted at 1-, 2-, and 4-months post-intervention to reinforce the intervention and assess the participants' level safety. the control group will receive usual care, which includes talking with a level 3 domestic violence advocate and receiving a comprehensive list of domestic violence resources. effectiveness of the mi intervention will be determined by increased self-efficacy, measured by the domestic violence coping and self-efficacy scale, a validated tool for use among women with a recent history of domestic abuse; and by a reduction in depressive symptoms (cesd-10). the impact of the intervention will be assessed by an increase in participants' readiness-to-change, and extent of their involvement in a wide variety of self-help and coping activities over the follow-up period. if successful, this screening and intervention program will be translated to other clinical settings.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * screens positive for ipv * literate in either english or spanish exclusion criteria: * less than 18 years of age * pregnant at time of screening and consent

Keywords: self-efficacy intimate partner violence randomized clinical trial depression
acupuncture first for ic/bps

Conditions: Bladder Pain Syndrome; Interstitial Cystitis

Summary: the goal of this clinical trial is to learn if acupuncture in addition to behavioral changes can better treat in women with bladder pain syndrome (also known as interstitial cystitis) that have not received other treatments. the main question it aims to answer is: does acupuncture improve pain symptoms on the interstitial cystitis index? researchers will compare six (6) weeks behavioral management alone to behavioral management and acupuncture. participants will * complete surveys about their bladder pain symptoms * make behavioral changes that have been shown to improve bladder pain symptoms * attend six (6) weekly acupuncture sessions * attend six (6) weekly physical therapy sessions after finishing acupuncture


Eligibility criteria:
inclusion criteria: * meets american urologic association (aua) criteria for interstitial cystitis/bladder pain syndrome (ic/bps): "an unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms of more than 6 weeks duration, in the absence of other identifiable cause" * negative urine culture * has completed cystoscopic evaluation for ic/bps exclusion criteria: * history of recurrent urinary tract infection (2 or more culture-positive in 6 months or 3 or more in 12 months) * history of overactive bladder * history of bleeding disorder or are currently on chronic anti-coagulation * post-void residual \>100ml * has previously undergone any of the following treatments for any indication: acupuncture, pelvic floor physical therapy, pre-tibial nerve stimulation (ptns), sacral neuromodulation, or intradetrusor botox * prior bladder augmentation * currently undergoing or will undergo treatment for a urologic or gynecologic malignancy * currently pregnant (if applicable, based on self-report) * implanted pacemaker or defibrillator (aicd) or any metallic implants below umbilicus (eg hip or knee replacements) * non-english speaking and reading

Keywords: acupuncture bladder pain syndrome interstitial cystitis
comparative efficacy of adm hydrogel vs. alginate dressings in chronic trauma wounds

Conditions: Trauma Wounds

Summary: the goal of this clinical trial is to find out whether a wound treatment made from acellular dermal matrix (adm) gel can help heal chronic traumatic wounds more effectively than standard alginate dressings in adults aged 18 and older with wounds that have lasted more than 3 weeks. the main questions it aims to answer are: does adm gel reduce the size of chronic wounds more than alginate dressings after 12 weeks? does adm gel help wounds heal faster and improve quality of life for patients? researchers will compare adm gel to alginate dressings to see if the adm gel leads to better healing results and fewer complications. participants will: be randomly assigned to receive either adm gel or alginate dressing. have the treatment applied directly to their cleaned wound. attend weekly visits for up to 12 weeks for wound checks, measurements, and dressing changes.


Eligibility criteria:
inclusion criteria: * chronic trauma wounds persisting ≥3 weeks. * wound size between 4 and 20 cm² and depth ≤9 mm on the lower limbs. * willingness and ability to provide informed consent. * wounds without uncontrolled infection exclusion criteria: * wounds with exposed bone. * current use of immunomodulators, corticosteroids, immunosuppressive or cytotoxic drugs. * pregnant individuals. * significant reduction (≥30%) of wound size during a 2-week run-in phase. * concurrent participation in another clinical trial involving drugs. * wounds with uncontrolled infection * allergy or hypersensitivity to components of adm gel or alginate

Keywords: chronic wound acellular dermal matrix adm wound size alginate
psilocybin-assisted psychotherapy for alcohol use disorder

Conditions: Alcohol Use Disorder; Alcoholism

Summary: the aim of this study is to determine if a single dose of psilocybin administered with motivational enhancement therapy (met) can reduce heavy drinking in patients with an alcohol use disorder (aud).

the primary objective of this study is to determine if psilocybin administered with a standardized psychotherapeutic intervention, motivational enhancement therapy (met), can reduce heavy drinking in a patient population with an alcohol use disorder (aud). patients with an aud will be randomly allocated to either a high dose (25mg; active treatment) or a low dose (1mg; active control) psilocybin arm. all participants will receive 5 sessions of met, starting at 24hrs post-dosing. heavy drinking will be assessed as percent heavy drinking days using the time line follow back (tlfb) at baseline and 1-, 4-, and 12-weeks post-dosing. a total of 128 male and female patients between the ages of 22-65 with a moderate to severe aud diagnosis will be recruited from the community. participants will undergo a thorough screening procedure and eligible participants will be randomly allocated to the high (n=64) or low (n=64) psilocybin doses. all participants will complete a baseline session consisting of clinical, behavioral, and neuroimaging measures. following the single dosing session, participants will complete 5 weekly met sessions. neuroimaging measures will be assessed again at 1-week post-doing. clinical and behavioral outcomes will be measured at 1-, 4-, and 12-weeks post-dosing

Eligibility criteria:
inclusion criteria: * meets dsm-5 aud criteria of at least moderate severity * meets heavy drinking requirements (heavy drinking days, number of drinks) in past 30 days * desire to decrease alcohol consumption * limited lifetime hallucinogen use exclusion criteria: * severe or moderate substance use disorder other than alcohol or nicotine in past 6 months * diagnosis of schizophrenia, bipolar disorders or first-degree relative with diagnosis * active suicidal ideation or serious attempt within past 3 years * currently pregnant, nursing, or trying to become pregnant * any notable abnormality on ecg, physical exam, or routine medical blood laboratory test
gut microbiota association with esbl-e colonisation and subsequent esbl-e infection

Conditions: Extended Spectrum Beta-Lactamase Producing Bacteria Infection; Microbial Colonization; Critical Illness

Summary: antimicrobial resistance is a major threat worldwide and extended-spectrum beta-lactamase producing enterobacteriales (esbl-e) are a leading cause because of their wide dissemination. gut microbiota seems to be correlated with multi-drug resistant organism carriage. this study thus aims to analyse the correlation between gut microbiota, esbl-e fecal carriage and subsequent infection.

the rising antimicrobial resistance has led to more than 33,000 deaths in europe in 2015. among them, extended-spectrum beta-lactamase-producing enterobacteriaceae (esbl-e) are the most frequent in europe and have disseminated both in the community and in healthcare settings. some studies have suggested that microbiota could be different between multi-drug resistant organisms, with different relative abundances of some bacteria. one study focused on esbl-e fecal carriers, but in the community, with bacteroides uniformis being more abundant in esbl-e non-carriers than carriers. as identification of species discriminating between esbl-e fecal carriers and non-carriers could pave the way for the design of esbl-e carriage eliminating probiotics, we aim to analyse the correlation between gut microbiota and esbl-e fecal carriage. moreover, mechanisms in the link between esbl-e fecal carriage and subsequent esbl-e infection remain, so far, poorly understood and this study aims to provide a first insight in the involvement of gut microbiota in the link between colonization and infection.

Eligibility criteria:
inclusion criteria: * patient above 18 year-old admitted to intensive care unit * esbl-e fecal carriage according to current screening recommendations for esbl-e carriage group * feces quantity on rectal swab adequate for routine screening and microbiota analysis exclusion criteria: * guardianship, curatorship, or prisoners * no health insurance * no legal representative

Keywords: esbl-e fecal carriage microbiota nosocomial infection
efficacy of an early antipsychotic switch in case of poor initial response to the treatment of schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder

Summary: the main aim of the trial is to study whether a change of medication in non-responders to a two-weeks antipsychotic drug trial is more effective than continued treatment with the same antipsychotic. hypothesis: non-responders who are switched at 2 weeks to another antipsychotic are more frequently in symptomatic remission at week 8 than non-responders who stay on the same antipsychotic

the patients will be randomised to a double-blind 2 week run in phase with fixed doses of either oral amisulpride 800 mg/day or olanzapine 20mg/day. those participants who have not responded to treatment at two weeks (panss improvement \<25%) will be randomised to a 6 week double blind flexible dose phase: 1. experimental intervention: switch to the other antipsychotic (oral olanzapine 5-20mg/d or oral amisulpride 200-800 mg/d) 2. control intervention: continuation with the same drug as in the first 2 weeks in flexible dose ranges as above for another six weeks those participants who have responded at week 2 (≥25% panss reduction) will continue on the same drug in flexible dose ranges as above total duration of intervention per patient: 8 weeks

Eligibility criteria:
inclusion criteria: * inpatients with diagnostic and statistical manual of mental disorders 4th edition text revision (dsm-iv tr) diagnosis of schizophrenia, schizophreniform or schizoaffective disorder * panss total score at baseline \> 75, at least two panss psychosis items ≥ 4, clinical global impression of severity score moderately ill or more (≥4) * increase in the level of care (outpatient care to day clinic or inpatient care) exclusion criteria: * contraindication to study drugs
effect of letermovir prophylaxis on cmv-specific immune reconstitution post ucbt

Conditions: Cytomegalovirus Infection Reactivation

Summary: to explore the effect of letermovir prophylaxis on cytomegalovirus-specific immune reconstitution post unrelated cord blood transplantation

to explore the effect of letermovir prophylaxis on cytomegalovirus-specific and other lymphocyte subsets immune reconstitution post unrelated cord blood transplantation, and to analyze the potential mechanism and risk factors of late cmv reactivation after letermovir discontinuation.

Eligibility criteria:
inclusion criteria: * patients are receiving a first unrelated cord blood transplantation (ucbt). * patients start letemovir prophylaxis within 0-28 days post ucbt. exclusion criteria: * patients having active cmv dnaemia at the time of letermovir initiation. * patients recruited in a clinical study on an anti-cmv trial.

Keywords: cytomegalovirus infection umbilical cord blood transplantation cmv-specific immune reconstitution letermovir
a study of roactemra/actemra (tocilizumab) versus placebo in patients with systemic sclerosis

Conditions: Sclerosis, Systemic

Summary: this multicenter, randomized, double-blind, placebo-controlled, two-arm, parallel-group study will evaluate the efficacy and safety of roactemra/actemra (tocilizumab) in participants with systemic sclerosis. participants will be randomized to receive either roactemra/actemra 162 mg subcutaneously weekly or placebo for 48 weeks. from week 48 to week 96, all participants will receive open-label roactemra/actemra 162 mg subcutaneously weekly. anticipated time on study treatment is 96 weeks.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * systemic sclerosis, as defined by american college of rheumatology (1980) criteria * disease duration of \</= 60 months (defined as time from first non-raynaud phenomenon manifestation) * \>/= 15 and \</= 40 mrss units at screening * active disease, as defined by protocol * uninvolved skin at injection sites * negative pregnancy test for a female subject of childbearing potential exclusion criteria: * major surgery (including joint surgery) within 8 weeks prior to and/or during study enrollment * rheumatic autoimmune disease other than systemic sclerosis * skin thickening (scleroderma) limited to areas distal to the elbows or knees at screening * previous treatment with tocilizumab * history of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies * severe cardiopulmonary disease * known active current or history of recurrent infections * use of any investigational, biologic, or immunosuppressive therapies including intra-articular or parenteral corticosteroids prior to study enrollment as specified in the protocol * as specified in the protocol, any current or past medical condition or medical history involving but not limited to the nervous, renal, pulmonary, endocrine, and gastrointestinal organ systems determined by the principal investigator to pose a significant safety risk to any subject while participating in the study * primary or secondary immunodeficiency
responsiveness and minimal important change of two measures of pain intensity in people with low back pain

Conditions: Low Back Pain

Summary: this is an observational study aimed at evaluating the responsiveness and minimal important change of two measures of pain intensity in people with low back pain. it consists of a battery of self-administered questionnaires which will be given to individuals with low back pain to complete before and after a rehabilitation treatment. relationships among the different outcome measures will be also evaluated.

this is an observational study aimed at evaluating the responsiveness and minimal important change of two different graphical ways to assess pain intensity in people with low back pain. literature found out that low back pain intensity is commonly assessed by a numerical rating scale ranging from no pain to the worst imaginable pain, once presented to responders horizontally. a different way to assess pain intensity could be to answer a similar numerical rating scale if set vertically. in literature there are not studies which head-to-head evaluate the responsiveness and minimal important change of these two ways of assessing pain intensity due to low back pain. participants will also have to complete self-reported outcome measures of disability, catastrophizing, fear of movement and self-efficacy, and correlations among these tools and the above two different ways to evaluate pain intensity will be evaluated. descriptive statistics will be presented by taking into account the socio-demographic characteristics of the sample under investigation.

Eligibility criteria:
inclusion criteria: * non specific low back pain * adult age * ability to understand the italian language exclusion criteria: * refuse to adhere to the study * definite causes of low back pain * central or peripheral neurological signs * systemic illness or psychiatric deficits * recent myocardial infarction, cerebrovascular events, or chronic lung or renal diseases
prophylactic pregabalin to decrease pain during medical abortion

Conditions: Acute Pain

Summary: medical abortion has been associated with significant pain. the objective of this trial is to determine whether one dose of pregabalin 300 mg, given during medical abortion in addition to the standard of care analgesics, will decrease experienced pain. investigators will perform a randomized, double-blinded, placebo-controlled trial. participant pain levels and side effects will be assessed at multiple time points, along with a measure of satisfaction.


Eligibility criteria:
inclusion criteria: * requested and consented for pregnancy termination by medical abortion * willing and able to complete multiple electronic surveys exclusion criteria: * previous participation in this trial * current use of pregabalin or gabapentin * contraindication to medical abortion with mifepristone and misoprostol * contraindication or allergy to ibuprofen, oxycodone, acetaminophen, or pregabalin * unable to understand and sign written informed consents in english
teamwork, targets, technology, and tight control in newly diagnosed pediatric t1d - 4t study

Conditions: Type1diabetes

Summary: the 4t program encompasses: teamwork, targets, technology, and tight range. these methods will help patients better manage their condition of type 1 diabetes with improved patient-reported outcomes.

the goal of the 4t study is to implement proven methods and emerging diabetes technology into the investigator's clinical practice to sustain a tight glucose range from the onset of type 1 diabetes (t1d) and optimize patient-reported and psychosocial outcomes. the investigators will define a program (4t - teamwork, targets, technology, and tight range) translatable to pediatric diabetes clinics in the united states that reduces hba1c and t1d burden and improves patient well-being. study design: this is a prospective, open-label, pragmatic research study. two related studies will be performed. in study 2, a cohort of new onsets (183) receiving the 4t new onset intervention designed to decrease the rise in hba1c seen from 4 to 12 months but following a tapered (from weekly to monthly) remote monitoring schedule will be compared to internal (4t pilot and 4t study 1) and external contemporaneous controls (cmh and dpv).

Eligibility criteria:
inclusion criteria: (inclusion criteria includes all youth with new onset t1d seen in the stanford/lucile packard children's hospital ages 6 months-21 years of age. we intend to include all possible patients with the goal of maximizing generalizability of the results and 4t program. (note: we will include children and families who speak all languages using the stanford interpreter services so as to have the greatest generalizability of the research. questionnaires will only be given to english and spanish speakers.) * all individuals within one month of t1d diagnosis seen at the stanford children's diabetes clinic * individuals who plan to receive follow up care at the stanford children's diabetes clinic * individuals who agree to cgm data integration into the emr for remote monitoring * age: six months to \< 21 years of age * patient or guardian must own and operate an apple compatible device (e.g., iphone or ipod touch) to allow for the dexcom app and cgm data transmission to the hospital server-based remote monitoring system. dr prahalad's lpch auxiliary fund grant (in addition to the r18) has resources to support ipod touch/iphone purchases for participants who do not have these. o for the exercise ancillary study: 11 to \< 21 years of age (the activity tracker is not validated for younger children) english and spanish-speaking (study 2) exclusion criteria: * diabetes diagnosis other than t1d * diagnosis of diabetes \> one month prior to initial visit * individuals with the intention of obtaining diabetes care at another clinic * individuals who do not consent to cgm use, cgm data integration, remote monitoring * individuals \> 21 years of age