Kornimate/medical-research-clean huggingface dataset:
family-centered hiv care, viral suppression and retention in hiv-positive children, swaziland

Conditions: HIV Infections

Summary: the study will evaluate the effect of implementing a family-centered care (fam-care) program (where all hiv-positive family members are seen together as a unit and receive care together) on viral suppression and retention in hiv-positive children \<15 years through enrollment of a prospective cohort of 660 hiv-positive children and their caregivers at sites that were randomized to either implement the family-care program (intervention sites) or continue the current standard of care (control sites).

the proposed study will evaluate the effect of implementing a fam-care program on viral suppression and retention in children through enrollment of a prospective cohort of hiv-positive children and their caregivers at sites implementing the fam-care program and control sites continuing the current standard of care. the study will be conducted in four "clusters" of facilities (2 hospitals and 2 health centers and their filter clinics) in the hhohho region of swaziland. two facility "clusters" (one hospital and one health center, with their filter clinics) will be randomized to initiate the fam-care program with viral load monitoring and two "clusters" (one hospital and one health center, with their filter clinics) will be control standard-of care sites. a prospective cohort of hiv-positive children and their caregivers will be followed in the fam-care program sites and control sites. each child will be followed for 18 months following enrollment. the primary objective is to evaluate the effect of the fam-care program on the rates of viral suppression and retention in care, comparing rates of viral suppression and retention in children enrolled in fam-care versus control sites. the study will also evaluate factors associated with viral suppression and retention (including family demographic characteristics), and conduct qualitative interviews to assess the acceptability of the fam-care program by caregivers and health care providers in the intervention sites.

Eligibility criteria:
inclusion criteria: * hiv-positive child aged \<15 years receiving hiv care at the study facility. exclusion criteria: * at least one family member residing in the household is also hiv-positive and is receiving services at the study facility
a study to assess antibody persistence, boostability & safety in previously primed subjects.

Conditions: Haemophilus Influenzae Type b; Tetanus; Whole Cell Pertussis; Hepatitis B; Diphtheria

Summary: the purpose of the study is as follows: * to evaluate the persistence of antibodies and the presence of immune memory induced by a 3-dose primary vaccination with tritanrix™-hepb/hib-menac (three formulations) in the study dtpwhb/hibmenactt001 (cpms no. 759346/001) by giving unconjugated prp, psa and psc at 10 months age to one subset of subjects. * to evaluate the persistence of all antibodies pertaining to primary vaccination and the booster response to tritanrix™-hepb/hib2.5 vaccine or tritanrix™-hepb/hib-menac vaccine at 15-18 months age in the other subset of subjects.

this study will be conducted in two stages: at 10 months age, half of the subjects will receive a dose of plain meningococcal ac and prp polysaccharide (ps) vaccine at 10 months age. at 15 to 18 months age (dtp booster phase), all subjects will receive a booster dose of tritanrix™-hepb/hib-menac or tritanrix™-hepb/hib2.5.

Eligibility criteria:
inclusion criteria: • healthy child 10 months that participated in the study dtpwhb/hibmenactt001 (cpms no. 759346/001), written informed consent obtained from the parents. exclusion criteria: * planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 30 days after administration of study vaccines with the exception of oral polio vaccine (opv). * use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during study period. * chronic administration (\> 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose. * previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis b, serogroups a or c meningococcal disease and/or hib since the last visit of study 759346/001. * history of/known exposure to diphtheria, tetanus, pertussis, hepatitis b, serogroups a or c meningococcal and/or hib disease. * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection.
phase 2 study of the safety and efficacy of uk-500,001 in adult patients with copd

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this initial proof of concept, phase ii study aims to assess the safety and efficacy of uk-500,001 for the chronic maintenance treatment of adults with chronic obstructive pulmonary disease.


Eligibility criteria:
inclusion criteria: * moderate-severe copd (global inititiative for chronic obstructive lung disease, gold, 2003 definition) * smoking history of at least 10 pack-years exclusion criteria: * any significant co-morbid disease * use of any maintenance therapy except short acting bronchodilators
evaluation of new onset postoperative atrial fibrillation

Conditions: Atrial Fibrillation New Onset

Summary: this is a multi-center, prospective, randomized and controlled clinical trial comparing the safety and efficacy of the cormatrix ecm for pericardial closure to reduce the incidence of new onset postoperative atrial fibrillation by circumferentially reconstructing the normal pericardial anatomy following isolated, first-time, cabg procedures compared to subjects that do not undergo pericardial closure. this trial will be conducted at up to 20 clinical sites in the u.s.

the objective of this prospective clinical trial is to demonstrate the safety and efficacy of the cormatrix ecm for pericardial closure to reduce the incidence of new onset postoperative atrial fibrillation by circumferentially reconstructing the normal pericardial anatomy following isolated, first-time, coronary artery bypass grafting (cabg) procedures as compared to subjects who did not undergo pericardial closure. safety will be established by demonstrating that the composite clinical event rate for the ecm treatment group is not worse than the control group that did not undergo pericardial closure. the efficacy will be established by demonstrating a reduced incidence of new onset postoperative atrial fibrillation in the ecm treatment group as compared to the control group.

Eligibility criteria:
inclusion criteria: * the subject is 18 years of age or older * this cardiac operation is the subject's first or primary cardiac operation * the subject must be undergoing an isolated cabg procedure using a median sternotomy approach * the subject must possess the ability to provide written informed consent * the subject must express a willingness to fulfill all of the expected requirements of this clinical protocol exclusion criteria: * prior history of atrial fibrillation * prior history of open heart surgery * prior history of pericarditis * prior history of anti-arrhythmia drug treatment (e.g., amiodarone, dronedarone or sotalol) in the past six months * the subject has an implantable cardiac device (i.e., cardiac resynchronization therapy devices with and without defibrillator capabilities (crts and crt-ds), implantable cardioverter-defibrillators (icd) and pacemakers) * concomitant procedure planned * in the investigator's opinion, the subject may require prophylactic treatment with anti-arrhythmia drugs or temporary pacing postoperatively

Keywords: coronary artery bypass grafting new onset postoperative atrial fibrillation
association of genetic polymorphisms with lipid lowering effects of statin therapy

Conditions: Statins, HMG-CoA; Single Nucleotide Polymorphism

Summary: the 3-hydroxy-3-methylglutaryl-coenzyme a reductase inhibitors, also known as statins, played an important role in lipid-lowering therapy and reduction of cardiovascular risks. however, it has been observed that the response to statin therapy varies from patient to patient, and gene polymorphism could have contributed to the variation.

hyperlipidemic patients are retrospectively screened from 2006/1/1 to 2006/12/31. the patient is included if he or she had been receiving atorvastatin or rosuvastatin for at least 3 months and did not receive other lipid-lowering medications 4 weeks before starting atorvastatin or rosuvastatin. genomic dna was collected from the blood sample of each patient using genomic dna purification kit. the single nucleotide polymorphisms (snps) were determined afterward. the correlation between response of statin therapy, defined as changes in lipid profiles including triglyceride, total cholesterol, high density lipoprotein cholesterol and low density lipoprotein cholesterol, and snps examined.

Eligibility criteria:
inclusion criteria: * aged 21-80. * conforms with the criteria of national cholesterol education program adult treatment panel iii for medication therapy. * have received atorvastatin or rosuvastatin regularly for 12 weeks or longer. * available lipid profiles such triglyceride, total cholesterol, high density lipoprotein cholesterol and low density lipoprotein cholesterol 12-24 weeks after staring statin therapy. exclusion criteria: * had been using lipid-lowering medications including statins 4 weeks before starting atorvastatin or rosuvastatin. * received other lipid-lowering medications, erythromycin, immunosuppressant or azole antifungals concomitantly. * pregnant, breast-feeding, or able to become pregnant. * have a history of alcohol or substance abuse. * liver cirrhosis or alt exceeds the upper limit of normal range. * untreated hypothyroidism. * patients with malignant tumor who have received chemotherapy or radiotherapy. * known allergy to atorvastatin, rosuvastatin or other statins. * unwilling to provide written informed consent.

Keywords: single nucleotide polymorphism statins hyperlipidemia
a study of hmpl-415s1 in patients with advanced malignant solid tumors

Conditions: Advanced Malignant Solid Tumors

Summary: the objective of this study is to evaluate the safety, tolerability and pk profile of hmpl-415s1 and determine mtd and/or rp2d in patients with advanced malignant solid tumor.

this study is expected to enroll 36-81 patients, including 26-66 patients for dose escalation, additional 10-15 patients will be enrolled at the dose level of determined rp2d.

Eligibility criteria:
inclusion criteria: all the following conditions must be met for enrollment: 1. fully understand this study and voluntarily sign the icf; 2. dose escalation patients with advanced malignant solid tumor confirmed by histopathology or cytology, who have failed, been intolerant or unavailable to, or have none standard treatment for various reasons; dose expansion phase: patients with advanced malignant solid tumor confirmed by histopathology or cytology, who have failed, been intolerant or unavailable to, or have none standard treatment for various reasons, carrying aberrant activating mutations in the kras pathway； 3. presence of at least one measurable lesion (recist 1.1 criteria); 4. eastern cooperative oncology group (ecog) performance status ≤ 1 point; 5. life expectancy ≥ 12 weeks as judged by the investigator; 6. male of childbearing potential and their heterosexual partners of childbearing potential must agree to use effective methods of contraception. exclusion criteria: a patient may not participate in this study if any of the following conditions apply: 1. patients who priorly received shp2 inhibitors; 2. receiving the approved systemic antitumor treatment within 4 weeks prior to the first dose, including: chemotreatment, targeted treatment, immunization treatment, biological treatment, etc. (wash-out for 2 weeks for hormone treatment or traditional chinese medicine and chinese patent medicine with clear antitumor indications); 3. have been in the treatment period of other interventional clinical studies (including small molecule chemicals and large molecule antibodies) within 4 weeks prior to the first dose. if participating in a non-interventional clinical study (eg, epidemiological study), you can enroll in this study; if already in the survival follow-up period of an interventional clinical study, you can enroll in this study. 4. major surgery or radical radiotreatment (except palliative radiotreatment for metastases to bone lesions) within 4 weeks prior to first dose. 5. central nervous system (cns) malignant tumor or known cns metastasis; 6. having multiple factors that affect the absorption, distribution, metabolism or excretion of orally administered drugs (such as inability to swallow drugs, frequent vomiting, chronic diarrhoea, etc.); 7. any other disease, metabolic abnormality, physical examination abnormal, or clinically significant laboratory test abnormality that, in the judgment of the investigator, would compromise patient compliance or give reason to suspect that the patient has a disease or condition that would compromise the interpretation of study results or place the patient at high risk.
norspan transdermal patches phase iii study in non-cancer pain

Conditions: Disease (or Disorder); Intervertebral Disc, With Myelopathy (Manifestation)

Summary: this is a multiple-dose, double-blind, double-dummy, active-control, parallel-group, multi-center, safety and efficacy study.


Eligibility criteria:
inclusion criteria: * males or females age are ≥20 ,≤80 years. * clinical diagnosis of musculoskeletal pain for 4 weeks or longer with non-malignant pain etiology at visit 1. * subject is a current user of nsaids or paracetamol and reports a history of insufficient therapeutic benefit in musculoskeletal pain. * subjects must record an 'average pain over the last week at study institution' score at primary pain site of ≥ 4 on an 11-point numerical pain rating scale. * subjects must be able to understands the study procedures and assessment, and agree to participate in the study by giving written informed consent. exclusion criteria: * subjects who have been taking long-acting or short-acting opioid analgesic formulations within the last 4 weeks. * subjects who have a current chronic disease(s) or who have a past history and high possibilities to relapse, in addition to their musculoskeletal pain, requiring frequent analgesic therapy. * subjects with clinically unstable respiratory disease, dysfunction of the biliary tract, thyroid disease, adrenal cortical insufficiency, prostatic hypertrophy requiring intervention or renal artery stenosis. * subject who have a past history of malignant neoplasm including leukemia and lymphoma. * subjects with clinically unstable, active or symptomatic heart disease. * subjects who have psychiatric disorder, uncontrolled seizures or convulsive disorder and so on. * subjects who have a current or past (within 5 years) history of substance or alcohol abuse, or subjects who give a positive result in drug abuse test during the screening period. * subjects scheduled for therapies within the study period which might effect study assessment. * females who are pregnant, lactating or have a possibility of being pregnant. * subjects with values \> 2 times the upper limit of normal for ast or alt or total bilirubin at visit 1 or who have severe impaired liver function. * subjects with serum creatinine \> 2 mg/dl at visit 1 or who have severe impaired renal function. * subjects with serum potassium \< 3.5 meq/l at visit 1. * subjects receiving hypnotics or other central nervous system (cns) depressants. * subjects receiving monoamine oxidase inhibitor (maoi) within 2 weeks before screening. * subjects who have a history of supersensitivity to study drug. * known intolerance to and/or lack of effect of tramadol. * subjects who participated in a clinical research study within 1 month of study entry. * subjects who participated previously in a btds study.
study of thoracic ultrasound as a response to the closure of hemodynamically significant patent ductus arteriosus in premature infants

Conditions: Patency of the Ductus Arteriosus

Summary: the diagnostic hypothesis is based on the evidence that, while the functional closure of the pda (patent ductus arteriosus) occurs within a few hours after birth, anatomical closure may take several weeks. the functional closure of the pda can be extremely sensitive to variations in blood oxygen tension and the hemodynamic instability of preterm infants. therefore, echocardiographic evaluation and ductal diameter at a single point in time (such as during pda echocardiography) may not correlate with transductal blood flow. assessing the variation in the amount of pulmonary interstitial fluid using lus (lung ultrasound score) could be an early predictive parameter for the closure or non-closure of hspda (hemodynamically significant pda).


Eligibility criteria:
inclusion criteria: * neonates under 28 days of life * patients eligible for hspda closure treatment according to standard clinical practice exclusion criteria: * neonates with congenital heart diseases (except for pda and patent foramen ovale) * neonates with pneumothorax * neonates with pulmonary hemorrhage
effect of neuromodulation and therapeutic exercise in urinary incontinence

Conditions: Urge Urinary Incontinence; Overactive Bladder (OAB)

Summary: urge urinary incontinence (uui) is a component of the condition known as overactive bladder, a severe and debilitating chronic disorder affecting healthcare systems worldwide. the efficacy of therapeutic exercise and neuromodulation in the treatment of uui is evaluated, and these techniques are combined.

urge urinary incontinence (uui) is a component of the condition known as overactive bladder, a severe and debilitating chronic disorder that affects the neurophysiology of micturition and bladder functionality, particularly in processes associated with menopause, leading to a deterioration in quality of life. various therapeutic approaches are employed to treat overactive bladder. among the most frequently implemented interventions are sacral or tibial nerve neurostimulation. this intervention targets the pathophysiological substrate by modulating the somatic afferent activity of the bladder and interfering with the activity of fibers responsible for pain modulation and neuromuscular system functionality. in essence, the described approach focuses on reducing peripheral input. based on the aforementioned information, it was hypothesized that training through a pelvic floor strength protocol, performed adjunctively with peripheral neuromodulation prior to its implementation, may provide the ability to inhibit detrusor contractions via involuntary contractions of the perineal musculature.

Eligibility criteria:
inclusion criteria: * present with a diagnosis of urinary incontinence or overactive bladder * women of menopausal age (\>45 years) * ≥3 months of duration * fulfill the established criteria for patient selection for neuromodulation treatment (urge urinary incontinence) * speak native spanish or english exclusion criteria: * prior or scheduled surgical procedures in the lumbar or abdominal region * presence of fractures or severe pathological conditions * current pregnancy or potential for pregnancy during the study period * neurological or psychiatric disorders * presence of stress urinary incontinence * female subjects with autoimmune diseases or malignancies * belonephobia * subjects who have undergone previous neuromodulation

Keywords: menopause exercise neuromodulation posterior tibial nerve
capella scientia development study

Conditions: Cataract

Summary: this study involves collecting biometry and aberration data using the next generation biometer, unity dx.

in this prospective, noninterventional, single-arm, unmasked, multicenter study, 4 different subject cohorts will be enrolled simultaneously to collect biometry and aberrometry data using unity dx. this study will be conducted in india, spain, and the philippines.

Eligibility criteria:
inclusion criteria: * able to understand and sign an irb/iec approved consent form; * willing and able to attend study visit(s) as required by the protocol; * consenting age at the jurisdiction of study site; * other group-specific, protocol required inclusion criteria may apply. exclusion criteria: * women of child-bearing potential; * unable to fixate due to nystagmus or other eye movement abnormality (e.g., significant strabismus); * unclear optical media preventing data capture from all devices in the study; * contraindicated for pupil dilation (e.g., narrow angles, allergies) per investigator's clinical judgment; * any ocular disease and/or condition that, in the investigator's clinical judgment, may put the subject at significant risk, may compromise study results, or may interfere significantly with the subject's participation in the study; * other group-specific, protocol required exclusion criteria may apply.
the effectiveness of rehabilitation training based on brain-computer interface technology to improve the upper limb motor function of ischemic stroke.

Conditions: Hemiplegia Following Ischemic Stroke

Summary: to evaluate the effectiveness and safety of rehabilitation training based on brain-computer interface in improving the upper motor function, self-care ability in daily life and quality of life in patients with ischemic stroke. this study adopts centralized uniform random 1:1 grouping, subjects will be randomly assigned to the experimental group and the control group. randomization schemes are generated by statistical professionals using sas software.

brain computer interface(bci) is a noninvasive nervous system intervention. as a new method, it is applied in rehabilitation by stimulating peripheral nerve, such as motor, vibration, sensory, in combination with other stimulations, such as transcranial magnetic stimulation, transcranial electrical stimulation, etc. in traditional rehabilitation therapy, hand-holding training is completed by physical therapist. rehabilitation robot is also used for auxiliary training. bci therapy will stimulate patients to take part in rehabilitation training more actively and obtain better effects on the rehabilitation of stroke.

Eligibility criteria:
inclusion criteria: 1. adult subjects (18 years\<male or female≤80 years ) 2. ischemic stroke diagnosed by mri within 1 month before randomization 3. unilateral upper limb dysfunction with nihss score 1-3 at the time of randomization 4. informed consent signed exclusion criteria: 1. unable to understand or cooperate because of severe aphasia or cognitive impairment (cdr \>0.5) or mental illness 2. a history of epilepsy 3. sensory disorders or hallucinations 4. internal carotid artery dissection or thrombolysis 5. apraxia 6. agnosia 7. other diseases that may interfere with motor function 8. severe cardiopulmonary disease, severe illness, and unstable vital signs 9. severe balance dysfunction 10. participating in other clinical trial 11. during pregnancy and lactation 12. the numerical rating scale (nrs) scores of upper extremities\>4.

Keywords: brain-computer interface electric stimulation therapy stroke rehabilitation