Kornimate/medical-research-clean huggingface dataset:
study of adefovir dipivoxil for korean patients with chronic hepatitis b(chb) who have completed adf 103814

Conditions: Hepatitis B, Chronic; Chronic Hepatitis B

Summary: this is an open label, single-arm, multi-centre extension study for korean patients with chronic hepatitis b and compensated liver disease who have completed one-year adefovir dipivoxil treatment in adf103814. the objective is to assess clinical efficacy and safety of long term (up to 3 years) adefovir dipivoxil 10mg therapy.


Eligibility criteria:
inclusion criteria: subject has completed adf103814 and continues with adefovir dipivoxil treatment via prescription without interruption prior enrolment in this extension study. availability and willingness of subject to provide written informed consent. exclusion criteria: use of immunosuppressive therapy requiring use of more than 5mg of prednisolone(or equivalent) per day, immunomodulatory therapy (including interferon or thymosin) or systemic cytotoxic agents during the study. previous or current lamivudine or antiviral therapy clinical signs of decompensated liver disease as indicated by the protocol inadequate haematological function defined by the protocol - documented evidence of active liver disease due to other causes hepatocellular carcinoma as evidenced by the protocol any serious or active medical or psychiatric illnesses other than hepatitis b which, in the opinion of the investigator, would interfere with patient treatment, assessment or compliance with the protocol. this would include any uncontrolled clinically significant renal, cardiac, pulmonary, vascular, neurogenic, digestive, metabolic (diabetes, thyroid disorders, adrenal disease), immunodeficiency disorders or cancer. active alcohol or drug abuse or history of alcohol or drug abuse considered by the investigator to be sufficient to hinder compliance with treatment, participation in the study or interpretation of results. planned for liver transplantation therapy with nephrotoxic drugs or competitors of renal excretion can be expected during the course of the study. history of hypersensitivity to nucleoside and/or nucleotide analogues. inability to comply with study requirements as determined by the study investigator.

Keywords: adefovir dipivoxil(hepsera) chronic hepatitis b (chb)
siroop registry - a prospective registry study to evaluate the outcomes of coronary artery disease patients treated with sirolimus or paclitaxel eluting balloon catheters

Conditions: Coronary Disease; Coronary Artery Disease; Coronary Restenosis; Coronary Arteriosclerosis; Coronary Artery Calcification; Stable Chronic Angina; Angina Pectoris; Angina, Stable; Angina, Unstable; Stent Thrombosis

Summary: the purpose of the siroop registry is to retrospectively and prospectively collect baseline, clinical and procedural characteristics of patients who have undergone pci and are treated with either currently available sirolimus or paclitaxel coated dcbs (see table 1), irrespective of clinical presentation as well as to prospectively collect data about their clinical outcomes. outcomes will be compared in different clinical subgroups. the impact of current dcbs in different clinical settings and coronary artery lesions on cardiovascular outcomes will be assessed.

objectives in detail: * to evaluate procedural success, efficacy, performance and clinical outcomes among various patient cohorts, who undergo pci using currently available dcbs: 1. periprocedural outcomes/complications, which will be analyzed, include: final result (e.g. residual stenosis, timi flow), dissections, perforations, prevalence of thrombus (assessed by angiography and intravascular imaging) 2. short and long-term clinical outcomes of interest comprise among others: new mi, unstable angina (ua), target lesion failure, target vessel revascularization, target lesion failure/ revascularization, repeat hospitalization, new/worsening heart failure, cardiogenic shock, stroke, bleedings, cardiovascular death and all-cause death. * to describe procedural and clinical performance of various dcb, either alone or in combination with other stent and coronary scaffold devices * to identify optimal strategies for lesion preparation in cases treated with dcb * to identify possible predictors for tlr after treatment with dcb * to describe early and late angiographic and oct-findings among coronary artery disease (cad) patients treated with dcb and/or various metallic stent and scaffold devices * to evaluate the impact of different antithrombotic regimens on patient's clinical outcomes * to study procedural and clinical outcomes among cad patients requiring hemodynamic support using mechanical devices. * to describe economic implications (cost-effectiveness) of various interventional treatments for cad.

Eligibility criteria:
inclusion criteria: * subject \>18 years of age * patients with significant acute or chronic coronary de-novo lesions or isr lesions requiring treatment using pci * treatment with at least one dcb (device choice at the operator's discretion) in case of a patient with lesions treated at different procedural time, lesions will be separately collected and documented * subjects must be willing to sign a patient informed consent (pic) or must have signed the general consent (gk). exclusion criteria: * patient is \<18 years of age * patient unwilling or unable to provide informed consent * pregnancy and lactation * indication for surgical revascularization
rose in sunset park

Conditions: Post Partum Depression

Summary: the purpose of this study is to learn more about pregnant women's' experience with reach out, stay strong, essentials for mothers of newborns (rose) and to evaluate the effectiveness of the rose program in preventing and reducing post-partum depressive symptoms, decreasing stress, and increasing social support among pregnant women.

this is a 2-phase study, including a feasibility phase (pilot, phase 1), and an outcomes evaluation phase (phase 2). phase 1 tests the acceptability and feasibility of a postpartum depression prevention intervention among pregnant women attending a prenatal clinic in sunset park, brooklyn. nyu research staff will be trained to implement this intervention. based on the feedback received from women and staff in phase 1, the intervention will be modified accordingly. phase 2 will be an outcomes evaluation to test the effectiveness of the intervention to decrease maternal stress and depressive symptoms, and increase perceived social support and self-efficacy among new mothers.

Eligibility criteria:
inclusion criteria: * receive prenatal care at the sunset park family health center for women's health and pediatrics (spwhp) * female * at least 18 years of age * speaks and understands english or spanish (depending on the language of the next group) * is pregnant * is in the second trimester of her pregnancy * capable of providing informed consent. * scores between 4 and 12 on edinburgh postnatal depression scale or records 2 or more aces on adapted aces questionnaire exclusion criteria: * not receiving prenatal care at the sunset park family health center for women's health and pediatrics (spwhp) * not female * under18 years of age * does not speak and understand english or spanish * is not pregnant * is not in the second trimester of her pregnancy * is not capable of providing informed consent. * scoring \ 12 on edinburgh postnatal depression scale and scores 1 or less on adapted aces questionnaire. * positive score to #10 on the edinburgh postnatal depression scale
effect of critical patients mobilization on respiratory and peripheral muscle strength and functional capacity.

Conditions: Intensive Care Unit Syndrome; Muscle Weakness

Summary: to analyze changes on respiratory muscle strength, peripheral and functional capacity of critically ill patients with clinical and surgical etiology, breathing spontaneously and bedridden, within 48 hours of admission to the intensive care unit (icu) and if there are correlations among these variables. this is an observational study. respiratory muscle strength will be assessed through the maximum inspiratory pressure (mip) and maximal expiratory pressure (mep) and peripheral muscle strength, by the medical research council score (mrc) and hand grip test and functional capacity through the functional independence measure (fim) and physical function icu test score (pfit-s) in the period between 24h and 48h of hospitalization in the adult icu. for descriptive purposes, the sample will be stratified according to clinical and surgical characteristics. correlations will be determined using the pearson test, with significance level of p \<0.05.


Eligibility criteria:
inclusion criteria: * breathing spontaneously * length of stay in icu greater than 24 hours * adherence to study exclusion criteria: * patients with poor prognosis or palliation; * preexisting neuromuscular diseases; * immobility or restriction to bed prior to admission; * nonunions and amputations; * osteomioarticular, cognitive or neurological impairment; * non-cooperation; * specific contraindications to the application of evaluation methods; * hemodynamic or respiratory instability within 48 hours of icu admission preventing evaluation muscle strength and functional capacity.
comparison of the efficacy of sacral espb and caudal block for pain management after urogenital surgeries in children

Conditions: Urogenital Diseases; Nerve Block; Pain, Postoperative

Summary: the aim of this study was to compare the efficacy of caudal block and sacral espb used as a postoperative analgesia method in urogenital pediatric surgery cases.

the parents of the patients who will undergo urogenital surgery will be included in the study after being informed and written consent is obtained. they will be randomised and divided into two groups. after general anaesthesia, sacral espb will be performed in the 1st group and caudal block will be performed in the 2nd group and postoperative pain will be evaluated with face, leg, activity, cry, consolability (flacc) score.

Eligibility criteria:
inclusion criteria: * patients aged 1-7 years undergoing paediatric urogenital surgery * patients in american society of anesthesiologist (asa) class i-ii exclusion criteria: * patients whose parents do not give consent * patients with anatomical changes in the sacral region, previous surgery, scar and infection, * patients with known local anaesthetic allergy * patients for whom regional anaesthesia is contraindicated * known neurological or muscular disease

Keywords: sacral erector spinae plane block caudal block nerve block anesthesia, general urogenital surgery
suboccipital release versus instrument- assisted soft tissue mobilization on tension type headache

Conditions: Suboccipital Release; Instrumental Assisted Soft Tissue Mobilization; Tension-Type Headache

Summary: the study aims to explore the impact of suboccipital release versus instrument-assisted soft tissue mobilization on pain intensity, pressure pain threshold, headache impact test, and headache frequency in patients with tension headache. the research will also examine the effects of these methods on headache impact tests and frequency.

headache prevalence ranges from 38.2 to 59.4%, with a lifetime prevalence of 26.1-45%. tension type headache can be episodic or chronic, with 78% occurring less than 15 times/month and 6% occurring more than 15 times/month. tension type headache has a greater socioeconomic burden, leading to lower productivity and workday loss. tension type headache is linked to myofascial pain and trigger points, which can cause sensory changes and reduced pain threshold. studies show that referred pain from myofascial trigger points reproduces headache in patients with , leading to increased symptom severity. frequent episodic tension type headache increases the risk of developing chronic tension type headache due to analgesic overuse. instrumental assisted soft tissue mobilization, a physical therapy technique, promotes fascia realignment and reduces strain on the clinician's hands.

Eligibility criteria:
inclusion criteria: 1. participants of both gender will be between the ages of 18 and 60. 2. episodic tension type headache criteria, according to the international headache society's headache classification committee., have at least two of the following characteristics. * recurrent episodes of headache on less than 15 days per month for at least 3 months * headache that last for from around 30 min till seven days. * at least 2 of the following features are found in a headache: * a location that is on two sides. * tightening/pressing quality (non-pulsating). * intensity is mild to moderate. * both of the following: not worsened by routine physical activity, there is no nausea or vomiting. * only have one photophobia/ phonophobia 3. patients have active trigger points in suboccipital muscle and upper trapezius muscle 4. the presence of myofascial trigger points was determined by therapist using the diagnostic criteria described by simons .,(1999) ,the major criteria of active myofascial trigger points were: regional neck pain, pain or altered sensation in the expected distribution of referred pain from a myofascial trigger point, taut band palpable in an accessible muscle. exclusion criteria: 1. patients who have had a history of cancer 2. patients who have had cervical and cranial surgery 3. patients with severe psychological disorders (major depression) 4. patients with uncontrolled hypertension 5. dysfunctions in the tempo-mandibular joint 6. headaches associated with high fever, stiff neck, or rash, problems of vision or profound dizziness 7. female who are pregnant or lactating
prospective randomized study comparing renal artery stenting (resist)with/without distal protection

Conditions: Renal Artery Stenosis

Summary: this study is designed to demonstrate the safety and efficacy of using a protective device/drug to prevent renal injury during renal artery stenting and to assess whether the preventative effects are measurable and if there is a differential treatment effect for either device alone or in combination.

this study is designed to demonstrate the safety and efficacy of using protective device/drug to prevent renal injury during renal artery stenting (ras) and to assess whether the preventative effects are measurable, and if there is a differential treatment effect for either device alone or in combination. specific goals of the study include: * to establish device and drug safety * to identify appropriate markers for renal injury * to measure effectiveness of drug and device * to enable the design of fda efficacy trials for renal artery stenting inclusive of device and or drug the study will address the four following hypotheses: * angioguard™ distal protection device provides significant protection from atheroembolization during ras procedures as measured by affected kidney gfr at 1 month after the procedure. * abciximab (reopro) offers protection against platelet aggregation and embolization as measured by affected kidney gfr at 1 month after the procedure. * angioguard™ and abciximab are safe, alone and in combination. * is there an interaction effect between angioguard™ and reopro for efficacy and safety?

Eligibility criteria:
inclusion criteria: any one or more of the following: meet angiographic criteria plus * systemic hypertension at baseline, or a history of hypertension * congestive heart failure at baseline, or a history of chf * renal insufficiency at baseline, or a history of renal insufficiency * angina, or a history of angina exclusion criteria: * less than 18 years old * contraindications to device/drug
a mobile phone based pilot intervention to prevent obesity in latino preschool children

Conditions: Childhood Obesity; Parenting; Mobile Phone Use

Summary: to pilot a stand-alone mobile phone intervention with latino caregivers of 2- to 5-year olds, using a prospective control group design, to assess feasibility and preliminary effect sizes on children's bmi changes (primary outcome) and dietary and physical activity changes (secondary outcomes) at 6 months post-baseline, in preparation for a larger randomized trial to evaluate the intervention's efficacy.

the investigators will pilot an mhealth intervention using a prospective control group design with 66 caregiver-child dyads (33 intervention and 33 comparison) recruited from two community based agencies in east los angeles. fidelity and feasibility will be assessed. pre- and post- intervention data (child dietary, physical activity, and media viewing behaviors and bmi z-scores) will be collected to estimate preliminary effect sizes and standard deviations. the mhealth intervention has been informed by a previous feasibility study and focus groups with latino caregivers of 2- to 5-year old children. this mhealth childhood obesity intervention specifically targets latino mothers, fathers, and grandmothers of 2- to 5-year olds. the intervention focuses on parenting skills, dietary, physical activity, and media-viewing behaviors consistent with american academy of pediatrics guidelines.

Eligibility criteria:
inclusion criteria: * adult male or female caregiver * self-identifies as an individual of latino descent * has a child or grandchild 2-5 years of age (relationship does not have to be biological but caregiver is a legal guardian) * lives with or cares for child/grandchild at least 20 hours/week * is fluent in english or spanish * has the ability to participate in the mhealth intervention (ability determined by using a subject comprehension and participation assessment tool) * agrees to complete baseline, 1-, and 6-month post-baseline surveys and have adult and child height and weight measured. exclusion criteria: * child has a failure to thrive diagnosis * medical complications associated with their weight status such as prader-willi syndrome
safety and pharmacokinetics study in adults for the prevention of s. epidermidis infection in low birth weight infants

Conditions: Staphylococcal Sepsis

Summary: the purpose of this phase 1 study is to evaluate the safety and pharmacokinetics of bsyx-a110 in a small number of healthy adult volunteers. following the demonstration of safety in adults, this anti-staphylococcal monoclonal antibody will then be evaluated in the target population of hospitalized low birth weight neonates.

this study will evaluate the safety of three doses of bsyx-a110 in adults before initiating studies in the target population of low birth weight infants. this will be an open label, dose-ranging study of bsyx-a110 in 12 adults. the dose levels to be evaluated are 3, 10 and 20 mg/kg. each dose level will enroll 4 adult volunteers who will receive one dose of bsyx-a110 intravenously. the primary endpoint of this study is safety and tolerability. the secondary endpoints include the pharmacokinetics of the rise in anti-lta antibody and opsonic activity against s. epidermidis.

Eligibility criteria:
inclusion criteria: 1. subjects must be 18 years of age or older. 2. subjects must in good general health, without significant medical history, physical examination findings or clinical laboratory abnormalities. 3. negative screening pre-treatment pregnancy test for female subjects. 4. subjects of childbearing potential must agree to use an acceptable method of contraception throughout the course of the study. 5. all aspects of the protocol explained and written informed consent obtained. exclusion criteria: 1. known or suspected immunodeficiency (e.g. hiv infection, significant risk factors for hiv, primary immunosuppressive disorder), use of immunosuppressive or antineoplastic drugs except corticosteroids used for indications other than immunosuppression. 2. clinically significant laboratory abnormality (greater than 1.5 upper limit of normal.). 3. serology positive for hiv, hepatitis b surface antigen or hepatitis c antibody. 4. history of leukemia, lymphoma or other malignancy. 5. clinically significant cardiac, respiratory, renal, hepatic, neurological disorder 6. pregnant or lactating females (women of childbearing potential will undergo a pregnancy test). 7. receipt of any vaccine within 30 days. 8. history of drug or alcohol dependence, or significant acute or chronic medical or psychiatric illness which would limit the subject's ability to complete the study and/or compromise the objectives of the study. 9. fever or acute illness within 3 days prior to treatment. (these subjects can be rescheduled for treatment at a later date). 10. participation in another investigational drug or vaccine trial within 30 days.

Keywords: a110 safety
covid-19 respiratory sequelae french cohort

Conditions: COVID-19; Fibrosis; Cohort; Follow-up; Sequelae; Spirometry DLCO

Summary: as the investigators need data on long term outcome of covid-19, especially respiratory sequelae, a national cohort is required. to better evaluate the potential respiratory sequelae after sars-cov-2 infection, it is fundamental to include patients with different management at the acute phase of the covid-19: ambulatory management, hospitalization in non icu and in icu units. that is why the investigators will conduct a national cohort study with all components of french pneumology which will give the investigators the opportunity to include patients in general hospital, in university hospital and in private structure. as it is a "real life" study, the investigators will include all patients who will have a consultation with a pneumologist for an evaluation 5 to 7 months after a covid-19 infection whatever their acute disease management. the investigators will collect all available data on covid-19 acute phase, on patients characteristics and comorbidities, on persistent symptoms after covid-19, on exams results during the outcome evaluation (ct-scan, 6 min walk test, spirometry and dlco, blood gas, vo2 max if realized).


Eligibility criteria:
inclusion criteria: * adults, older than 18 * sars-cov-2 infection confirmed by polymerase chain reaction (pcr) in nasopharyngeal swab in patients who are evaluated by a pneumologist 5 to 7 months after their covid-19 disease exclusion criteria: * patients for whom follow-up would be difficult owing to psychotic disorder * dementia * patients who have declined to participate.

Keywords: covid-19 fibrosis cohort follow-up sequelae spirometry dlco
prognosis of veno-venous extracorporeal membrane oxygenation in emergency thoracic surgery

Conditions: VV-ECMO; Thoracic Surgery; Emergency Surgery; ARDS; Retrospective Cohort; Propensity Score Matching; Mortality; ECMO Outcomes

Summary: veno-vneous extracorporeal membrane oxygenation (vv-ecmo) is an established support strategy for acute respiratory failure, but its role in the perioperative management of emergency thoracic surgery remains poorly defined. this retrospective, multicenter, observational study aims to assess the clinical outcomes and prognostic factors in this high-risk population. patients undergoing emergency thoracic procedures requiring vv-ecmo will be compared to a control cohort of patients treated with vv-ecmo for medical respiratory failure. data will be collected from two french academic centers (chu amiens-picardie and chu dijon).


Eligibility criteria:
inclusion criteria: * adults ≥ 18 years * vv-ecmo initiated during or after emergency thoracic surgery * no opposition to data use exclusion criteria: * pregnant women * veno-arterial ecmo patients * patients under legal protection

Keywords: thoracic surgery vv-ecmo emergency surgery ards retrospective cohort propensity score matching mortality ecmo outcomes