Kornimate/medical-research-clean huggingface dataset:
antibody response to prophylactic qhpv vaccine at 48 months among hiv-infected girls and boys

Conditions: HPV Vaccine; HPV Infection; HIV-1-infection

Summary: longitudinal observational cohort study and extension of the misp id: 38406 'immunogenicity and safety of quadrivalent human papillomavirus vaccine in hiv-infected pre-adolescent girls and boys in kenya'.

we evaluated for persistence of hpv antibody by measuring titers to specific hpv types 6, 11, 16 and 18 at re-enrollment month 24 , 36 and 48 months in addition to month 7 and 12, after initial vaccination. this provided data for immunogenicity among hiv-infected children for approximately 48 months after initial vaccination. we assessed decline over study intervals in hpv type-specific antibodies.

Eligibility criteria:
inclusion criteria: * receipt of 3 doses of qhpv vaccine * participated in primary immunogenicity study * consent/assent with parental consent for participants age \<18 years * willing to continue extended follow up for 36 months exclusion criteria: * decline consent

Keywords: hpv vaccine, hiv infection, adolescents, africa
daratumumab in treating patients with multiple myeloma

Conditions: Plasma Cell Myeloma

Summary: this phase ii trial studies the side effects and how well daratumumab works in treating patients with multiple myeloma when the infusion is accelerated. monoclonal antibodies, such as daratumumab, may interfere with the ability of tumor cells to grow and spread.

primary objectives: i. determine the safety and tolerability of decreasing the infusion time of daratumumab in patients that have already received 2+ doses of daratumumab and are continuing on daratumumab. ii. estimate the time savings versus (vs) predicted infusion time. outline: patients receive daratumumab intravenously (iv) over 1.5 hours. treatment continues in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed up for 4 weeks.

Eligibility criteria:
inclusion criteria: * patients must have received \>= 2 daratumumab infusions and be scheduled to receive another dose * all races and ethnic groups are eligible for this study * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * any other medical condition, including mental illness or substance abuse, deemed by the principal investigator to likely interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results * concurrent use of complementary or alternative medicines that in the opinion of the principal investigator would confound the interpretation of toxicities and/or antitumor activity of the study drug * prisoner
dexmedetomine vs dexamethasone in tab block for abdominal surgries

Conditions: Anesthesia

Summary: randomized controlled clinical trial to compare the efficacy and duration of postoperative analgesia achieved after adding dexmedetomidine or dexamethasone to bupivacaine in tap block for lower open abdominal surgeries.

a comparative study between the use of dexmedetomidine versus dexamethasone as adjuvant to bupivacaine in ultrasound-guided transversus abdominis plane block for post-operative pain relief in patients undergoing lower open abdominal surgeries

Eligibility criteria:
inclusion criteria: adult patients, age 20-60 years. elective operation under general anesthesia. physical status: asa i and ii patients. body mass index 25-35 kg/m2. exclusion criteria: * infection at site of injection. * patient refusal. * psychiatric or physical illness that lead to inability to cooperate, speak or read. * abdominal operations under spinal anesthesia. * history or evidence of coagulopathy. * known allergies to drugs used . * preexisting neurological disorders.
an efficacy and safety study for rivaroxaban in patients with acute coronary syndrome

Conditions: Acute Coronary Syndrome; Myocardial Infarction; Myocardial Ischemia; Unstable Angina

Summary: the purpose of this study is to determine whether rivaroxaban in addition to standard care reduces the risk of the composite of cardiovascular death, myocardial infarction, or stroke in patients with a recent acute coronary syndrome compared with placebo.

acute coronary syndrome (acs) is a serious and life threatening condition. following an acute coronary syndrome event patients are at risk of important additional clinical events such as death, myocardial infarction, and stroke. six months after patients present with an index event of st-segment myocardial infarction, approximately 15% will either have died or had another episode of myocardial ischemia, and a similar situation exists for non-st-segment elevation myocardial infarction/unstable angina patients. this randomized; double-blind; placebo controlled study will evaluate the efficacy and safety of rivaroxaban in addition to standard care in patients with a recent acs. patients will be given rivaroxaban (2.5 mg twice daily or 5 mg twice daily) or placebo (twice daily) in addition to standard care.

Eligibility criteria:
inclusion criteria: * patients must be currently receiving aspirin therapy alone or in combination with a thienopyridine per national or local dosing recommendation * have been hospitalized for symptoms suggestive of acute coronary syndrome that lasted at least 10 minutes at rest and occurred 48 hours or less before going to the hospital exclusion criteria: * any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding * need for continued anticoagulant therapy * significant renal impairment or known significant liver disease

Keywords: rivaroxaban acute coronary syndrome acs aspirin thienopyridine unstable angina myocardial infarction anticoagulation clopidogrel (plavix)
long term extension safety study in patients with dementia of the alzheimer's type who completed study cpc-001-07

Conditions: Dementia of the Alzheimer's Type

Summary: this is a long-term-safety roll-over extension study for a phase ii study (protocol cpc-001-07).

this is a long-term-safety roll-over extension study for a phase ii study (protocol cpc-001-07). patients having safely completed the 12-week maintenance phase of study cpc-001-07 will be eligible for admission. subjects will remain on their cpc-201 mtd as determined in study cpc-001-07. the dose of cpc-201 will be increased from 15 mg/day (administered in study cpc-001-07) to 20mg/day starting on day1. for those patients who do not tolerate 20mg/day cpc-201, the dose of cpc-201will be decreased to its previously tolerated level of 15mg/day. this protocol allows to increase patients' mtd of cpc-201, as previously determined in the phase ii study (cpc-001-07 protocol) by, 5mg or 10mg increment up to a maximum of 60 mg/day starting on day7 or month 3 visits of this extension protocol per investigator's judgment and patient's tolerability. this extension study is intended to continue for each enrolled patient for up to 6 months unless medically contraindicated. patients may withdraw from this study at any time. upon termination of this study, patients will return to their original daily donepezil dose of 10 mg/day and will continue to receive cpc-201 mg/day for one final week.

Eligibility criteria:
inclusion criteria: 1. have signed an institutional review board (irb) approved informed consent document indicating that they understand the purpose of and procedures required by the study and are willing to participate in the study and comply with all study procedures and restrictions. informed consent must be obtained from the patient and/or a designated representative prior to initiating any procedures of the study. 2. have safely completed 12 week maintenance phase of cpc-001-07 study. exclusion criteria: 1. renal and hepatic dysfunction with: total bilirubin: \>1.5 x unl ast: \>2.5 x unl alt: \>2.5 x unl serum creatinine: \>1.5 x unl creatinine clearance: \<30 ml/min (calculated by cockcroft and gault equation) 2. history or presence of myasthenia. 3. ecg findings of: complete left bundle branch block; ventricular pacing; 2nd degree or 3rd degree av block; atrial fibrillation or atrial flutter; hr \ 100; pr \>220 msec; or qtcf \>450 msec in male, \>470 msec in female 4. patients considered unlikely to co-operate in the study, and/or poor compliance anticipated by the investigator. 5. any other clinically relevant acute or chronic diseases which could interfere with patients' safety during the trial, or expose them to undue risk, or which could interfere with study objectives.
response evaluation of cancer therapeutics in metastatic breast cancer to the bone

Conditions: Metastatic Breast Cancer

Summary: this is a non randomized, single arm study, where each patient will undergo imaging with computed tomography (ct) and whole-body magnetic resonance imaging (wb-mri) at different timepoint. the primary endpoint is time to progression as documented by ct or wb-mri.

this is a monocentric study. all patients will undergo assessments by ct and wb-mri at all time points. * a baseline bone scan or fluorodeoxyglucose-position emission tomography (fdg-pet) will be performed. * ct scans and wb--mri are performed every 12 weeks until week 96, and then every 24 weeks until disease progression is evident (as defined in section 7.1.3). * at the point of disease progression, a repeat bone scan or fdg-pet/ct will be obtained in addition to the ct and wb-mri. participation in the trials ends at the point of disease progression. patients will be reviewed in outpatient clinic: * at baseline * every 12 weeks until week 96, with the results of their recent scans. * as with the imaging, the trial visits will change to every 24 weeks after the week 96 visit. at the week 12 and week 36 visits, the patients will undergo a clinical examination and perform a pain thermometer score and patient imaging questionnaire.

Eligibility criteria:
inclusion criteria: * histological diagnosis of breast cancer * single or multiple bone metastases (additional extraosseous or non-bony metastatic disease permitted) * due to start a new line of either hormone therapy or chemotherapy (use of bisphosphonates / denosumab or targeted agents e.g. trastuzumab in addition to hormone therapy / chemotherapy permitted) * aged 18 and over * life expectancy of over 6 months * no current active malignancy other than breast cancer exclusion criteria: * radical treatment to sole site of metastatic disease e.g. cyberknife to solitary bone metastasis * absolute contraindication to mri studies, ct scans, bone scans or fdg-pet/ct * pregnancy * psychological, familial, sociological or geographical conditions that would hamper compliance with the study protocol; such conditions should be discussed with the patient as part of the informed consent process.

Keywords: metastatic breast cancer whole body magnetic resonance imaging
effect of emergency department care reorganization on door-to-antibiotic times for sepsis (lds swarm)

Conditions: Septic Shock; Sepsis

Summary: sepsis is a common syndrome resulting from a dysregulated response to infection. the timing of antibiotic initiation is an important determinant of outcomes for patients presenting to the emergency department with sepsis. the potential effect of care reorganization on very early care for sepsis is unknown. this study will investigate whether multidisciplinary coordination of the initial patient evaluation in the emergency department influences door-to-antibiotic time for septic patients.

this is a retrospective cohort study of emergency department sepsis care before versus after implementation of a "swarming" model for simultaneous patient evaluation by multidisciplinary care providers. the analysis will use data from similar hospitals that did not change sepsis care organization during the study period to control for changes in sepsis care not resulting from the "swarming" intervention.

Eligibility criteria:
primary inclusion criteria: * adult patients age ≥18 years * presented to the ed of study hospital from may 16, 2015 to april 15, 2016 (pre-implementation cohort) or may 16 to november 15, 2016 (post-implementation cohort) * sepsis present in ed (sequential organ failure assessment \[sofa\] score ≥2 points above baseline while in ed plus antibiotic initiation while in the ed) * triage acuity score 2-5 inclusion criteria for supplemental sensitivity analyses: * presented to the ed of study hospital between may 16, 2015 and april 15, 2016 (pre-implementation cohort) or may 16, 2016 and february 15, 2017 (post-implementation cohort). * sepsis on presentation to ed, defined as initial sequential organ failure assessment (sofa) score ≥2 points above baseline plus antibiotics initiation within 24 hours of ed arrival. overall exclusion criteria: * age \<18 years * no antibiotics within 24 hours of ed arrival

Keywords: door-to-antibiotic time emergency department care antimicrobial care reorganization severe sepsis swarming
effect of rdx-002 on postprandial triglycerides in subjects treated with olanzapine

Conditions: Drug-induced Weight Gain

Summary: this phase 1b study rdx-002-22-09 has been planned to evaluate the effect of rdx-002 on postprandial triglycerides and apob48 levels in normal healthy subjects treated with the atypical antipsychotic drug, olanzapine.

this phase 1b study rdx-002-22-09 has been planned to evaluate the effect of rdx-002 on postprandial triglycerides and apob48 levels in normal healthy subjects treated with the atypical antipsychotic drug, olanzapine. it is a randomized, open-label, parallel group study that will be conducted at a single study site in the us. normal, healthy subjects aged 18-50 years and with a body mass index (bmi) of 18-27.5 kg/m2 will be eligible for screening. screening (day -28) will begin approximately 28 days prior to baseline (day 1). subjects will be admitted to the clinical research unit (cru) on the morning of day -1 and will remain in the cru until discharge on day 16.

Eligibility criteria:
inclusion criteria: * a glycated hemoglobin (hba1c) level of \<5.7% at screening * a 12-lead electrocardiogram (ecg) at screening which, in the opinion of the investigator, had no abnormalities that compromised safety in this study * hematology, clinical chemistry and urinalysis at screening, the results of which fall within normal parameter ranges and/or are deemed clinically acceptable by the investigator exclusion criteria * males and nonpregnant, nonlactating females exclusion criteria: * any prior use of or contraindication to atypical antipsychotics * concomitant use of drugs known to impact the pk of olanzapine * type 1 or type 2 diabetes * recent cv event * uncontrolled hypertension * fasting triglycerides ≥400 mg/dl * fasting glucose ≥100 mg/dl * any condition that impacts the absorption of dietary fats * significant gastrointestinal disorders * gall bladder disease * uncontrolled hypothyroidism * liver disease or dysfunction * renal disease or dysfunction * gastrointestinal conditions * hematologic disorders * active malignancy * psychiatric disorder * history of drug or alcohol abuse * pregnant, breastfeeding, or intending to become pregnant * use of weight loss products * blood donation or loss within 30 days prior to screening
the role of lipofilling after oncoplastic breast surgeries : evaluation of outcomes and patient satisfaction

Conditions: Cancer, Breast

Summary: the role of lipofilling after oncoplastic breast surgeries : evaluation of outcomes and patient satisfaction

lipofilling is the process of relocating autologous fat to change the shape, volume, consistency and profile of tissues. for over a century, surgeons have used autologous fat to enlarge and reshape the breasts. autologous fat grafting has gained popularity in recent years, although concerns exist regarding the safety and efficacy of this practice in breast surgery . autologous fat grafting represents an important tool for the management of secondary contour deformities of reconstructed breasts; fat grafting is a simple, safe, and effective treatment option, with low morbidity. it is a straightforward and quick reconstructive technique that does not generally interfere with adjuvant therapies .patient surveys have demonstrated that irradiation has a significant and negative effect on patient satisfaction . fat grafting seems to reduce radiation induced complications .improve cosmetic results, and reduce postoperative discomfort and pain. the aim of this study is to measure patient satisfaction with their breasts, as well as quality of life. with the advent of liposuction in the 1980s, large amounts of unwanted fat could be removed from different body areas using small access incisions and a suction cannula. in this setting, fat grafting was re-introduced in the early 80s, pioneered by the american mel bircoll, who first described a series of fat transplantation for breast augmentation and reconstruction

Eligibility criteria:
inclusion criteria: female gender. age of 18 years and older. history or in candidate for a mastectomy in the near future. patients undergoing prophylactic mastectomy. patients' choice to undergo a breast reconstruction. wanting to participate in this study. patient is able to wear the brava (bra like vacuum-based external tissue expander) device. exclusion criteria: active smoker or a history of smoking 4 weeks prior to surgery. current substance abuse. history of lidocaine allergy. four weeks or less after chemotherapy. history of radiation therapy in the breast region. oncological treatment includes radiotherapy after mastectomy. kidney disease. steroid dependent (daily or weekly). immune-suppressed or immune-compromised disease. uncontrolled diabetes. body mass index of \>30. large breast size (ie, larger than cup c), unless the patient prefers reduction of the contralateral side towards cup c. extracapsular silicone leaking from the encapsulated implant from a previous breast reconstruction.
expiratory muscle strength training for hypernasal speech in children

Conditions: Velopharyngeal Insufficiency; Velopharyngeal Incompetence Due to Cleft Palate; Inadequate Velopharyngeal Closure; Palatopharyngeal Incompetence; Hypernasality

Summary: when the soft palate does not move enough because of a cleft palate or for unknown reasons, this can lead to a speech difference called velopharyngeal insufficiency. the purpose of this research study is to test if soft palate exercises using a hand help breathing device will help improve the ability of the soft palate to close the area between the throat and nose and help improve speech.

the objective of this study is to examine the feasibility and efficacy of expiratory muscle strength training to improve velopharyngeal closure in patients with velopharyngeal dysfunction and nasal air emissions. a randomized, controlled trial will be conducted at a cleft craniofacial center at a tertiary children's hospital. patients will be block randomized based on pittsburgh weighted speech scale (pwss) score (5-6 or 7+) to expiratory muscle strength training for 6 to 8 weeks or no exercises. patients with reductions in nasal resonance during this time will be further randomized to emst maintenance training for 6 months or no exercises.

Eligibility criteria:
inclusion criteria: * pittsburgh weighted speech scores of 5 or greater * ages 5-17 years exclusion criteria: * caps-a-am hypernasality score \<2 * previous speech surgery (e.g. palatoplasty or pharyngeal flap) * speech surgery scheduled within the next 56 days * unable or unwilling to perform the tests and exercises outlined in the study

Keywords: cleft palate speech intelligibility
acute rehabilitation in patients with covid-19 pneumonia

Conditions: COVID-19; Rehabilitation; Physical Medicine

Summary: covid-19 can have different clinical manifestations including myalgia, arthralgia, neurological, cardiac, psychological and other manifestations.these patients are at greater risk of developing consequences of prolonged bed rest. therefore physical medicine and rehabilitation could have an important role in the multidisciplinary treatment of these issues. early respiratory and neuromuscular rehabilitation is necessary to improve functional physical limitations, performance, muscle strength, endurance as well as cognitive and emotional domains. some studies proposed that rehabilitation protocols in the inpatient setting include early mobilisation, strength and endurance training with the aim of reducing weakness and dependency. this study aimed to detect the effects of rehabilitation in patients with covid-19 who were admitted in temporary covid hospital in serbia. furthermore, to emphasize the importance of functional assessment of the patients, in identifying their problems and selections of priorities in planning the best therapeutic protocol.


Eligibility criteria:
inclusion criteria: * positive pharyngeal or nasal swab for sars cov-2, 3) sp o2\> 94% on admission, 4) body temperature under 37.5 5) clinical stability defined by ability to perform bedside active mobilization without a reduction of oxygen saturation (spo2) below 92%; exclusion criteria: * 1) sp o2 \< 94% on admission, 2) moderate and severe heart failure (grade iii and iv, ny heart association), 3) paresis or plegia as a result of cvi or neurodegenerative disease, 4) impaired cognitive status.

Keywords: acute rehabilitation covid-19 pneumonia