Kornimate/medical-research-clean huggingface dataset:
effectiveness of supportive housing on covid-19 related outcomes for people experiencing homelessness

Conditions: Housing; Covid19; Mental Health; Physical Health; Social Interaction; Healthcare

Summary: this study aims to understand the comparative effectiveness of two psh models (pb-psh and ss-psh) on quality of life and covid-19 related health behaviors by following for 6 months a cohort of 800 peh who have been placed in either pb (n=400) or ss (n=400). in a natural observational experiment, participants will complete 6 monthly mobile-based questionnaires exploring quality of life including physical, mental, social, and housing/environmental health, covid-19 prevention practices (i.e., handwashing, social distancing, face covering), and past-30-day healthcare utilization. a sub-sample of 40 participants living in both pb-psh and ss-psh will be qualitatively interviewed longitudinally to help contextualize quantitative findings. focus groups will also be conducted with providers of psh and qualitative interviews will be conducted with other key stakeholders to understand perspectives on the challenges of implementing and sustaining covid-19 related prevention practices while maintaining a continuity of care.

this study will aim to understand the comparative effectiveness of pb-psh and ss-psh on patient-centered quality of life, health care utilization, and health behaviors that will reduce covid-19 risk by following a diverse sample of 800 peh who are placed in pb-psh (n = 400) or ss-psh (n = 400) for 6 months. barriers and facilitators will also be identified that may affect psh implementation during the pandemic and its aftermath. the specific aims are: aim 1: to test the comparative effectiveness of pb-psh and ss-psh on covid-19-related health behaviors (covid-19-related personal health practices including social distancing) for peh over time. aim 2: to test the comparative effectiveness of pb-psh and ss-psh on patient-centered quality of life (i.e., general life satisfaction; physical, mental, social, and environmental health) for peh over time. aim 3: to test the comparative effectiveness of pb-psh and ss-psh on health care utilization health behaviors and unmet need for care for physical health, mental health, substance use disorders, for peh over time. aim 4: to contextualize quantitative findings through longitudinal qualitative inquiry with 40 participants, purposively sampled from pb-psh and ss-psh, based on whether they are following social distancing guidelines. aim 5: to understand service providers, policy makers, and other stakeholders perspectives on challenges of implementing and sustaining covid-19-related prevention practices and continuity of care in psh.

Eligibility criteria:
inclusion criteria: * adults (aged 18+) with recent (past 12 months) lived experience with homelessness * approved for psh * proficient in english * able to provide informed consent exclusion criteria: * aged younger than 18 * not approved for psh * not proficient in english * unable to provide informed consent
dose escalation study of bibf 1120 in combination with carboplatin and pld in relapsed ovarian cancer (oc)

Conditions: Ovarian Neoplasms

Summary: this phase i, open label dose escalation study will investigate the addition of bibf 1120 to treatment with the combination of carboplatin and pegylated liposomal doxorubicin (pld) in patients with advanced, platinum sensitive relapsed ovarian cancer, fallopian tube carcinoma or primary peritoneal cancer. patients will be treated with bibf 1120 together with carboplatin and pld in up to 6-9 repeated 28 days treatment courses until disease progression is observed.


Eligibility criteria:
inclusion criteria: 1. female patients, age 20 years or older, with relapse of histologically (on initial diagnosis) confirmed epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal cancer 2. up to 3 lines of prior chemo therapy, with treatment free interval of \>6 months 3. platinum based chemotherapy in the immediately preceding line. 4. eastern cooperative oncology group (ecog) performance score 0 or 1 5. written informed consent that is consistent with good clinical practice (gcp) guidelines exclusion criteria: 1. prior chemotherapy with pld, and any contraindication for therapy with carboplatin or pld. 2. more than 2 lines of prior therapies that contained angiogenesis inhibitor. 3. patients for whom surgery is planned, e.g. interval debulking surgery. 4. history of a cerebral vascular accident, transient ischemic attack or subarachnoid haemorrhage within the past 6 months. 5. serious infections in particular if requiring systemic antibiotic (antimicrobial, antifungal) or antiviral therapy. 6. laboratory values indicating an increased risk for adverse events. 7. significant cardiovascular diseases.
a text messaging program to help prevent early opioid relapse

Conditions: Substance-Related Disorders

Summary: the objective is to determine feasibility and acceptability of a text message (sms)-based relapse prevention intervention as measured through: (1) study retention and sms query completion rates and (2) participant ratings of pier1 interest, perceived efficacy, and ease of use. methods: a mixed methods study of adult (age \>=18) ed patients who seek treatment for opioids and have evidence of dependence based on rapid opioid dependence screen (rods) score of \>3 and are being discharged to outpatient (community) resources. all participants receive standard of care in the ed, complete a baseline web survey, are asked to text with us for at least 7 days (up to a max of 28 days) and are asked to complete a follow-up phone call between day 8 and 14. investigators expect preliminary findings to support a relapse prevention intervention delivered through sms. based on feedback from this mixed methods study, investigators plan to test a refined sms program in a randomized trial.

the vast majority of those with opioid dependence do not receive treatment. this may be due to the limited availability of existing treatment programs and to a range of societal and individual-level barriers, including the stigma associated with identifying oneself as a substance user and difficulty attending a treatment program on a regular basis. technology-based interventions have potential to help address these barriers and to expand access to evidence-based psychosocial treatment. automated, computer-based interventions have found high user acceptance and utilization and shown promise in treating substance use disorders. the current study will evaluate a text-message-based psychosocial program called pier1 (preventing and interrupting early relapse 1) when delivered to treatment-seeking opioid-dependent emergency department (ed) patients. pier1 is an interactive program based on the relapse prevention model. it is also informed by cognitive behavioral therapy and motivational interviewing.

Eligibility criteria:
inclusion criteria: * age 18 - 60 years * seeking treatment for substance abuse (chief complaint of "detox") * english speaking * opioid dependence (nursing history of opioid use + rods score\>3) * ownership of a mobile phone with text messaging * medically and psychologically stable (as determined by the clinician or investigator) exclusion criteria: * no mobile phone ownership or mobile phone without text messaging capabilities * incarcerated/in police custody * being treated for a self-inflicted injury or suicidal ideation (as determined by the clinician) * medical condition affecting cognition (as determined by the clinician or investigator's discretion) * unable to read, speak, or comprehend english (at the clinician or investigator's discretion) * patients who are under the influence of illicit drugs or alcohol (at the clinician or investigator's discretion)
study of the analgesic effect of the perineal infiltration of ropivacaine 0.75% versus placebo in post-episiotomy perineal pain

Conditions: Episiotomy

Summary: episiotomy is a common obstetric gesture (20 to 30% of deliveries by the low route). in postpartum, perineal pains associated with episiotomy are common, about 70% on d7 and persistent 13% at 5 months. most studies of obstetrical analgesia have focussed on pain during labor or following a caesarean section. the perineal pain associated with the realization of an episiotomy has been much less studied and often undervalued. local ropivacaine has shown its effectiveness in the reduction of postoperative pain in many indications (wall surgery, hemorrhoidectomy, infiltration of trocar scars during laparoscopy). this product has the advantage of being well tolerated, easy access and administration. three recent studies compared the post-episiotomy analgesic efficacy of local ropivacaine versus lidocaine versus placebo and lidocaine versus no infiltration. two of these studies showed statistically significant results. however, they focused on the results at 24 and 48 hours and did not evaluate the analgesic efficacy in the medium and long term.


Eligibility criteria:
inclusion criteria: * major patient (≥ 18 years) * term ≥ 37 weeks of amenorrhea * right medio-lateral episiotomy performed for medical need * delivery of a single fetus in a cephalic presentation with or without instrumental extraction * delivery under epidural anesthesia * patient to be monitored over 6 months of study * patient in ability to understand protocol * patient having given consent and signed informed consent * patient with social coverage exclusion criteria: * hypersensitivity or known allergy to ropivacaine or to other amide-linked local anesthetics or to any of the excipients * general contraindication specific to local anesthesia, irrespective of the local anesthetic used * contraindication for ropivacaine- obstetric paracervical anesthesia * hypovolemia * weight \<50 kg * contra-indication or refusal of the epidural * poor understanding of the french language * substance addiction. * chronic pain syndrome. * severe hepatic or renal impairment. * acute porphyria. * caesarean section programmed. * tear of the 3rd degree according to the associated french classification. * refusal to participate in the study * patient under tutelage, curatorship, or deprived of liberty
mitraclip for severe tr

Conditions: Tricuspid Regurgitation

Summary: the aim of this study was to investigate the procedural feasibility and 30-day results of transcatheter tricuspid valve repair using the mitraclip® system (abbott vascular) in selected, highly symptomatic patients with severe tricuspid regurgitation (tr).

the primary objectives of this prospective analysis were to determine the feasibility in terms of success rate and short-term clinical follow-up at 30 days. in this context procedural success was defined as reduction of at least one tr grade. at 30-days after the procedure, a clinical follow up was performed in the heart failure outpatient clinic of our department including transthoracic echocardiography for the evaluation of tr grades. furthermore, the investigators determined nyha functional class and the incidence of major adverse cardiac and cerebrovascular events (macce). secondary objectives were the assessment of right ventricular function, the 6-minute walk distance, nt-probnp as well as quality of life as assessed by the minnesota living with heart failure questionnaire (mlhfq) score at 30-days follow up.

Eligibility criteria:
inclusion criteria: * right-sided heart failure due to moderate-to-severe tricuspid regurgitation * patients deemed inoperable by the heart team exclusion criteria: * poor echo-image quality
non-invasive tear film dynamic measurements in normal, mgd and adde subjects after saline instillation

Conditions: Aqueous Deficient Dry Eye; Meibomium Gland Dysfunction

Summary: compare the objective tear film dynamic measurements in three different populations (mgd \[meibomium gland dysfunction\], adde \[aqueous deficient dry eye\] and normal/control \[non-dry eye\]) and the subjective experience before and after instilling a single drop of saline in each eye. currently available office-based tests for dry eye do not reliably correlate with patients' subjective symptoms. this study is interested in assessing how individuals with these two different ocular surface diseases compare with the normal population when measured objectively using two different instruments.

there will be one study day with a single visit that will consist of taking two sets of measurements. baseline measurements are taken in both eyes using a wavefront sensor to measure visual quality followed by saline instillation. five minutes after drops, visual quality is again measured to evaluate changes in tear dynamics.

Eligibility criteria:
general inclusion criteria: * good general health * the subject must appear able and willing to adhere to the instructions set forth in this protocol (such as not use warm compresses or artificial tears/lubricant or excessive eye makeup before the visit on the study day). general exclusion criteria: * ocular disease, infection or inflammation (allergy, blepharitis) that is clinically significant (grade 3 or 4) that in the opinion of the pi would not be a good subject. * systemic disease or use of medication that in the opinion of the pi would not be a good subject. * infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. hiv). * contact lens wearer. * pregnancy or lactation. * diabetes. * inclusion or exclusion criteria of the other cohorts. cohort specific inclusion criteria: * adde cohort: schirmer i \< 10 mm, but ¬\< 5 seconds, fluorescein 0 or 1, currently using an artificial tear for ocular comfort at least occasionally. * mgd cohort: diagnosis of moderate or severe mgd * normal/control (non dry-eye): meets general inclusion and exclusion criteria

Keywords: aqueous deficient dry eye (adde) meibomium gland dysfunction (mgd) normal/control (non dry eye)
enhancing self care among oral cancer survivors: the empowered survival trial

Conditions: Oral Cancer; Oropharyngeal Cancer; Head and Neck Cancer

Summary: project's goal is evaluate an online tool the research team created called empowered survivor (es) against a free online self-management intervention developed for cancer survivors by the national cancer institute and the american cancer society called springboard beyond cancer.

600 patients who have completed treatment between one and three years ago and are currently cancer-free will be recruited via the new jersey state cancer registry or the cancer registry of greater california and randomly assigned to es or springboard beyond cancer. participants will complete measures at baseline, 2, and 6-months post-baseline. the investigators will also complete a process evaluation of empowered survivor.

Eligibility criteria:
inclusion criteria: * age \> 18 years; * diagnosed with a first primary invasive oral or oropharyngeal cancer between 1 and 3 years ago; * currently cancer free (but can have experienced a recurrence); * has internet access; * read english; * has sufficient vision to read a survey and complete an online intervention exclusion criteria: -
surgical technique to control postpartum hemorrhage

Conditions: Post Partum Hemorrhage

Summary: placenta accreta is an obstetrical complication where the placenta becomes firmly adherent to the uterine wall. placenta accreta can lead to considerable maternal morbidity and mortality due to hemorrhage, infection, or other surgical complications such as those resulting from hysterectomy. retained placenta accreta is usually a rare condition, but its prevalence is increasing due to the rise in the rate of deliveries by cesarean section. placenta accreta is a potentially life-threatening obstetric condition that requires a multidisciplinary approach to management. the incidence of placenta accreta has increased and seems to parallel the increasing cesarean delivery rate. women at greatest risk of placenta accreta are those who have myometrial damage caused by a previous cesarean delivery with either an anterior or posterior placenta previa overlying the uterine scar. diagnosis of placenta accreta before delivery allows multidisciplinary planning in an attempt to minimize potential maternal or neonatal morbidity and mortality.


Eligibility criteria:
inclusion criteria: 1. estimated gestational age between 34 -40 weeks . 2. presence of total or focal parts of placenta accreta "morbidly adherent placenta" . 3. cases with mild vaginal bleeding or not having any vaginal bleeding exclusion criteria: 1. severe attack of bleeding require an immediate intervention. 2. associated with placental abruption 3. patients with known bleeding disorders or on anticoagulant therapy. 4. preoperative decision to do peripartum hysterectomy.
using a connected application to maintain physical activity after cardiac rehabilitation

Conditions: Cardiac Rehabilitation; Acute Coronary Syndrome; Heart Failure

Summary: maintaining physical activity after cardiac rehabilitation has a major role in disease progression and patient prognosis. 6 months after the cardiac rehabilitation, we find during a nursing interview that many patients do not maintain regular physical activity. 1 year after cardiac rehabilitation, between 30% and 60% of patients do not maintain the recommendations in terms of physical activity. it is recommended to perform studies evaluating the effectiveness of new technologies in the fight against non-compliance recommendations for physical activity. that is why, study the interest of using an application connected post-cardiac rehabilitation seems necessary to fight against dropouts in terms of physical activity.

the objective is to study compliance with the recommendations, assessed by accelerometer at 6 months post-cardiac rehabilitation within two groups : classic care versus using a connected application.

Eligibility criteria:
inclusion criteria: * patient participating in cardiac rehabilitation * patient with a smartphone compatible with the application * patient with internet connection * patient having signed the written consent to participate exclusion criteria: * patient reluctant or unable to comply with the protocol * pregnant, parturient and nursing mothers * persons deprived of their liberty or under guardianship

Keywords: cardiac rehabilitation acute coronary syndrome heart failure
assessment of foxp3 gene polymorphisms and serum interleukin 10 in patients with itp

Conditions: Thrombocytopenia

Summary: immune thrombocytopenia (itp) is an autoimmune condition characterized by increased platelet destruction and suppression of production resulting in isolated thrombocytopenia. the exact etiology of itp is unknown; however, multiple disease mechanisms exist and are mostly related to immune dysregulation \[1\]. many studies in recent years have indicated that regulatory t cells (tregs) play a critical role in the maintenance of immunological tolerance, and they have been reported to be defective in itp patients, either numerically or functionally. \[2-6\]. they inhibit the activation and proliferation of effector t cells by the secretion of cytokines such as interleukin-10 (il-10) and tumor growth factor-β (tgf-β) and by cell-to-cell interaction \[7, 8\].

the suppressor function of treg cells may be compromised if the foxp3 gene is deficient. foxp3 gene single nucleotide polymorphisms (snps), particularly regulatory polymorphisms in the promoter regions, have been linked to a variety of autoimmune diseases, including allergic rhinitis, type i diabetes (tid), systemic lupus erythematosus (sle), multiple sclerosis (ms), and autoimmune thyroid diseases (aitd), according to numerous studies \[9-13\]. the foxp3 gene's promoter region, which is crucial in gene expression and treg activation, may contain important snps. the 6054 del/att and 924a \> g snps are functionally well-defined and are distinguished by the relevance of studies on them among these snps. \[14, 15\]. the interleukin 10 (il-10) cytokine is required for regulating immune functions by promoting the widespread suppression of immune responses through its pleiotropic effects. il-10 secretion from cd4+cd25+foxp3+ regulatory cells (tregs), macrophages and other leukocytes followed by subsequent binding to il-10 receptors on macrophages and dendritic cells (dcs) has been linked to reduced antigen presentation and increased t-cell anergy \[16\]. the relationship between the two foxp3 polymorphisms and itp has not been well elucidated, hence the objective of this study is to explore if these functional polymorphisms are linked to itp, how they correlate to il-10 levels, and how they relate to other features of clinical presentation in adult patients with itp.

Eligibility criteria:
inclusion criteria: * patients with primary itp and aged 18 and older will be included in the study. exclusion criteria: 1. patients under 18 and those with proven secondary itp \[as cases initiated by or associated with infections due to human immunodeficiency virus (hiv-associated), hepatitis b virus, or hepatitis c virus-associated secondary itp\] . 2. patients with accompanying autoimmune disorders such as systemic lupus erythematosus (sle). 3. patients with malignancies will be excluded

Keywords: polymorphism foxp3 serum il10
dynamx bioadaptor global post-market registry: clinical trial of the elixir medical dynamx novolimus eluting coronary bioadaptor system

Conditions: Coronary Artery Disease

Summary: the goal of this registry is to confirm the safety, and performance of the dynamx novolimus eluting coronary bioadaptor system in patients with coronary artery disease.

this registry will obtain additional safety, effectiveness, and performance data on the dynamx novolimus-eluting coronary bioadaptor system in the treatment of patients with ischemic heart disease due to de novo native coronary artery lesions in a real-world patient population.

Eligibility criteria:
inclusion criteria: 1. over 18 years of age 2. patient understands the trial requirements and treatment procedures and provides informed consent 3. patient indicated for pci with stent implantation and receive at least one dynamx bioadaptor implant in accordance with the product's instructions for use (ifu). exclusion criteria: 1. target lesion(s) in the left main artery 2. prior venous or arterial bypass grafts 3. in-stent restenosis 4. patient is currently participating in another clinical trial with an investigational device or an investigational drug that has the potential to impact study results (e.g., anti-thrombotic or anti-platelet medications) that has not yet completed its primary endpoint 5. patient is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the registry for any reason