Kornimate/medical-research-clean huggingface dataset:
development of a new hiv vaccine

Conditions: HIV Infections

Summary: the purpose of the study is to determine the safety of a new hiv vaccine and to evaluate the immune response to the vaccine. only some hiv genes are used to make the vaccine and therefore the vaccine cannot itself cause hiv or aids.

hiv-1 presents several challenges to vaccine design, including: 1) high mutation rates resulting in tremendous diversity of virus envelope, the target of neutralizing antibody, such that antibody elicited to one envelope may not protect from virus with a distinct envelope; 2) envelope from infected persons differs from envelopes obtained from t-cell line cultures, the usual source of envelope for vaccines; and 3) envelope glycoprotein exists as oligomers on the virion surface, not as the monomers used in previous vaccines. this study will test a new vaccine that has been designed to meet these challenges by delivering diverse, patient-derived, oligomeric envelopes to induce multiple type-specific responses capable of recognizing native envelope on natural variants. the vaccine vector used in this vaccine trial is recombinant vaccinia virus based on the nycdh vaccinia isolate. participants in this study will receive the polyenv1 hiv vaccine and will be followed for one year. laboratory tests will be performed at 10 study visits to monitor the participants' immunologic response and assess the safety of the vaccine. patients will also have numerous hiv tests throughout the study period.

Eligibility criteria:
inclusion criteria: * hiv-1 negative * availability for one year of follow-up * no evidence of previous smallpox vaccination * acceptable methods of contraception exclusion criteria: * immunosuppressive or chronic illness * medical or psychological conditions which could affect compliance * high risk for hiv infection * live attenuated vaccines within 60 days * experimental agents within 30 days * blood products within past 6 months * eczema * pregnant or lactating women * household contact with immunodeficient person, pregnant woman, or child less than 12 months of age * allergy to gentamicin

Keywords: hiv preventive vaccine hiv seronegativity
postoperative progression of the disease following extensive versus limited mesenteric excision for crohn's disease

Conditions: Postoperative Surgical Recurrence

Summary: the study evaluates whether there is a reduction in the rate of postoperative progression of the disease following extensive mesenteric excision (eme), when compared to that of limited mesenteric excision (lme), in patients undergoing ileocolic resection for crohn's disease. half of participants will receive eme, while the other half will receive lme.

eme and lme are the two surgical procedures which are commonly used in the treatment of crohn's disease. however, the areas of the mesenteric tissue resected are different. eme means that the mesentery is resected avoiding the root region, i.e. 1 cm from the root of ileocolic artery and vein. lme represents that the mesentery is retained, i.e. "close shave" or 3 cm from the border of bowel (using whatever approach - clips, or haemostatic vessel sealing device).

Eligibility criteria:
inclusion criteria: * patients with crohn's disease limited to the distal ileum and/or right colon receiving their index ileocolonic resection * patients with a documented history of crohn's disease based on endoscopic, radiological, or histological criteria exclusion criteria: * pregnancy or willingness to become pregnant in the following year * previous ileocolic resection history * patients having crohn's disease lesion at a gastrointestinal site other than the terminal ileum cecum, or right colon * patients having an internal fistula which required resection of another segment of bowel
post exposure prophylaxis for leprosy in the comoros and madagascar

Conditions: Leprosy

Summary: this is a cluster randomized trial on effectiveness of different modalities of single double dose of rifampicin post-exposure prophylaxis (sddr-pep) for leprosy in the comoros (anjouan and mohéli) and madagascar. the study aims to identify which approach to the selection of contacts for post exposure prophylaxis is most effective to reduce incident leprosy, and to interrupt ongoing transmission from asymptomatic persons in the process of developing multibacillary leprosy.

for the purpose of the study, villages on the comoros and madagascar that will be randomly assigned to one of the study arms, will be screened on a yearly basis for 4 consecutive years. depending on which of the 4 arms a village is assigned to, people in the surroundings of a leprosy patient will or will not be offered post-exposure prophylaxis (pep) using rifampicin at 20mg/kg single dose: 1. no post-exposure prophylaxis (pep) is given to anyone 2. pep is given to all household contacts of incident leprosy cases 3. pep is given to all people who live in a 100m radius of incident leprosy cases 4. pep is given to all household contacts of incident leprosy cases as well as to all others who live within a 100m radius of an incident leprosy case and test positive in the ucp-lfa detecting anti-m. leprae pgl-i igm antibodies (ab) in fingerstick blood (anti-pgl-1)

Eligibility criteria:
inclusion criteria: * living in one of the study villages * aged 2 years and above * able and willing to provide informed consent exclusion criteria: * signs of active leprosy (\*) * signs of active pulmonary tuberculosis (cough ≥2 weeks duration) (\*) * having received rifampicin within the last 24 months (\*) (\*) these people may still be included for yearly leprosy screening, but will be excluded to receive pep
uterine artery blood flow in pregnant women with pcos treated with metformin

Conditions: Polycystic Ovary Syndrome

Summary: flowmet study is a "sub-study" of the pregmet study (registered in 2005). the aim of the flowmet study is to register the possible effect of metformin on the blood flow of the uterine artery in pregnant pcos women. the participants will be examined with ultrasound doppler in gestational week 10-13: 1. before and 3h after the first tablet intake of metformin/placebo 2. and 10-14 days after inclusion in the trial 3. blood flow in the umbilical artery and fetal cerebral artery in gestational week 24.


Eligibility criteria:
inclusion criteria: * same as in the pregmet study. as this study is a sub-study/extended study of the pregmet study, only those included in the pregmet study (nct00159536) can participate. exclusion criteria: * same as in the pregmet study

Keywords: pcos pregnancy metformin blood flow pulsatility index
a descriptive study to explore certain characteristics of patients at risk for chronic obstructive pulmonary disease (copd) in a primary care setting

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to explore if certain characteristics, easily detected within a regular primary care setting, may indicate that a patient at risk for copd (45 ≤ age ≤ 80 years and a smoking history of ≥ 15 pack years) is prone to have a diagnosis of copd according to medical products agency guidelines.


Eligibility criteria:
inclusion criteria: * patients with a history of smoking one pack of cigarettes per day for 15 years or more exclusion criteria: * known chronic obstructive pulmonary disease * known severe cardiovascular disease

Keywords: copd copd-6 spirometry vc fev fev1
civilian post-traumatic stress disorder risperidone clinical trial

Conditions: Post-Traumatic Stress Disorders

Summary: the purpose of this study is to determine whether the administration of risperidone is effective in the treatment of selective serotonin reuptake inhibitor (ssri)-resistant post-traumatic stress disorder (ptsd) in civilians.

individuals with ptsd often experience anxiety attacks, nightmares, or repeated unwanted memories after experiencing or witnessing life-threatening events, such as serious accidents or natural disasters, or traumatic events such as physical or sexual abuse. risperidone has been approved by the food and drug administration for the treatment of psychotic disorders and has been found helpful for ptsd and depression, but is still considered investigational for the purposes of this study. all qualified participants will be started on sertraline (zoloft) for eight weeks. patients who are still symptomatic at the end of this phase, will be invited to join the second portion of the study where they will be randomly assigned to receive risperidone or placebo (sugar pill) in addition to the sertraline. participants will be monitored regularly for medication effects, adverse events, and ptsd symptoms.

Eligibility criteria:
inclusion criteria: * meets criteria for dsm-iv ptsd for a minimum of one month duration * clinician-administered ptsd scale (caps) score \> or = to 50 * able to read and complete questionnaires and interviews * negative urine drug screen exclusion criteria: * pregnant or nursing * primary psychotic disorder; psychotic disorder; or cognitive disorder. * prominent suicidal or homicidal ideation * alcohol or substance dependence within 3 months of starting study * primary anxiety disorder or bipolar disorder * patients currently being treated with antipsychotic medication * patients in active psychotherapy aimed at ptsd * combat-related ptsd

Keywords: post-traumatic stress disorder sertraline risperidone
comparative assessment of utilization of antiviral therapies in hepatitis c and effectiveness of daclatasvir-containing regimens in real-life clinical care in europe (cmpass-eu)

Conditions: Hepatitis

Summary: the study aims to collect information on the current treatment patterns for hepatitis c in participating countries. there is also a focus on patients receiving a daclatasvir-containing treatment regimen who will be followed prospectively for 12 months after treatment initiation to collect real-world data on effectiveness and safety of the treatment. additional analysis will differentiate between selected subpopulations.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * adult (≥18 years at inclusion) * diagnosed with a chronic hepatitis c infection * whose physician has already decided to initiate a new hcv treatment or a new daclatasvir-containing regimen * informed consent to participate in the study exclusion criteria: * participation in a clinical trial or an early access program for hcv therapies
bevacizumab and erlotinib in the treatment of patients with carcinoma of unknown primary site

Conditions: Neoplasms, Unknown Primary

Summary: this trial will investigate the combination of bevacizumab, and erlotinib in patients with adenocarcinoma or poorly differentiated carcinoma of unknown primary site. bevacizumab and erlotinib are relatively well-tolerated and have non-overlapping toxicity profiles. this trial will be one of the first clinical trials to evaluate a combination of targeted agents in the treatment of a solid tumor.

upon determination of eligibility, patients will be receive: * bevacizumab + erlotinib

Eligibility criteria:
inclusion criteria: to be included in this study, you must meet the following criteria: * carcinoma of unknown primary site confirmed by biopsy * measurable disease * ecog performance status must be 0-1 * adequate bone marrow, liver and kidney * understand the nature of this study and give written informed consent. exclusion criteria: you cannot participate in this study if any of the following apply to you: * age\< 18 years * may not have received egfr inhibitors * history of acute myocardial infarction within 6 months * clinically significant cardiovascular disease * moderate to severe peripheral vascular disease. * history of stroke within 6 months * history of abdominal fistula, perforation, or abscess within 6 months * active concurrent infections * serious underlying medical conditions * active brain metastases * women who are pregnant or lactating. * peg or g-tube * proteinuria * any nonhealing wound, ulcer, or bone fracture. * any clinical evidence or history of bleeding, clotting or coagulopathy please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
expanding autism diagnostic biomarkers to kenya

Conditions: Autism

Summary: the study will use a non-invasive remote eye-tracking system (eyelink portable duo) to acquire a short series of eye-tracking measures.

the study will use a non-invasive remote eye-tracking system (eyelink portable duo) to acquire a short series (less than 15 mins) of eye-tracking measures (e.g., looking time, pupil diameter, oculomotor dynamics), which may be associated with autism in young children. the investigators will recruit children from moi teaching and referral hospital (mtrh; eldoret, kenya) previously enrolled in the health equity advancing through learning health systems research (heal-r) autism at mtrh study (irec/664/2023, approval number 0004633)

Eligibility criteria:
inclusion criteria: * children enrolled in the heal-r autism at mtrh study * children ages 14-72 months * caregivers of children must speak kiswahili (local language) or english. exclusion criteria: * children not enrolled in the heal-r autism at mtrh study * children younger than 14 months or older than 72 months * caregivers of children do not speak kiswahili (local language) or english.
evaluation of an interactive opioid risk education program (stomp) for parents

Conditions: Pain, Postoperative; Medication Adherence; Opioid Use; Knowledge, Attitudes, Practice; Risk Reduction Behavior

Summary: millions of children and adolescents are prescribed opioid pain relievers each year, placing them at risk for serious adverse events and misuse in the home setting. parents who manage these medicines, therefore, need to recognize opioid-related risks and make decisions that will both reduce these risks yet ensure effective pain relief for their children. the proposed research will evaluate new strategies to help parents learn about opioid risks, make safe and effective analgesic decisions, and develop and demonstrate safe drug management behaviors. 840 parents and their children who are undergoing an elective surgical procedure will be recruited. parents will be randomized to receive the new educational and practical behavioral strategy or routine information. parents' knowledge and perceptions will be evaluated at baseline and at critical times after surgery. parents' opioid handling and administration will also be assessed.

the overarching goal of this research is to improve opioid analgesic safety and efficacy by optimizing opioid risk recognition, informed analgesic decision-making, and drug storage/disposal behaviors among parents of youth who are prescribed these agents for home use. the study aims are to determine whether the scenario-tailored opioid messaging program (stomp) will: 1) improve parents' opioid risk understanding and their analgesic decision-making; 2) enhance parents' analgesic self-efficacy, analgesic use, storage behaviors and their children's pain outcomes, and 3) to demonstrate that the stomp plus provision of a simple method to get rid of left-over opioids will effectively nudge parents to safely dispose of left-over opioid analgesics. parents whose children are prescribed opioids for acute, short-lived pain after surgery will be randomly assigned to receive our interventions or a routine provider informational interaction at the time of opioid prescribing. parents will be surveyed about their opioid familiarity, knowledge, risk perceptions and common analgesic decision-making at baseline and after hospital discharge. parents will also record their child's pain medication use and symptoms after discharge. data will be analyzed to determine whether the stomp educational intervention with or without the behavioral nudge intervention will enhance parents' risk perceptions, their decision-making skills and their opioid handling behaviors.

Eligibility criteria:
inclusion criteria: * parent (\>=21yr) and child (5-17 yr) (dyad) who lives in the home and is prescribed an opioid for postoperative pain management * english speaking exclusion criteria: * child is undergoing a non-elective procedure * child cannot self-report pain levels (i.e., is cognitively impaired) * child has a hematologic/oncologic condition * child has a kidney or liver conditions that precludes the usual analgesic prescription pattern (opioid plus a non-opioid) * child has been taking opioids for prolonged pain pre-operatively (\>2 weeks)
an open label study to describe the pharmacokinetics of cefazolin in preterm neonates

Conditions: Sepsis; Prematurity

Summary: this is a phase i open label multi-dose study to investigative the pharmacokinetics and safety of cefazolin in infants \ 48 hours of age and ≤28 days and 2) \>28 days of age and \<121 days of age. the study requires administration of the study drug over 2 days followed by 1 week of safety monitoring. six 200 µl pk samples will be obtained over the 2 days of drug administration. the risks are reasonable vs. the benefits and have been minimized appropriately. there may be benefit to the subjects (administration of empirical antimicrobial therapy), and information from the study may benefit a large number of other infants in whom the drug is currently being administered despite the lack of pk data in this population.


Eligibility criteria:
inclusion criteria: * \< 28 weeks gestation at birth * \> 48 hours and \<121 days of age at the time of study drug administration * one of the following: * suspected systemic infection * receiving cefazolin for prophylaxis * receiving cefazolin treatment of a systemic infection exclusion criteria: * history of anaphylaxis attributed to a β-lactam * exposure to cefazolin in the month prior to study * serum creatinine \> 1.7 mg/dl
effect of joint mobilization on alpha motoneuron reflex excitability

Conditions: Muscle Spasticity; Spinal Cord Injury; Stroke; Craniocerebral Trauma

Summary: objective: to determine the effect of ankle joint mobilization on the alpha motoneuron reflex excitability of the soleus muscle in people with spasticity. subjects and methods: a controlled clinical trial with crossover design and simple masking was conducted in 24 randomized subjects to initiate the control or experimental group. traction and rhythmic oscillation were applied for five minutes to the ankle joint. alpha motoneuron reflex excitability was assessed by measuring h wave amplitude (hoffmann reflex - h reflex), stimulating the tibial nerve at the level of the popliteal fossa and recording in the soleus muscle. in each subject 12 measurements were taken: basal rate, during and after mobilization. changes in alpha motoneuron reflex excitability were calculated in relation to basal measurement. for each measurement a hypothesis test was performed (student t test). results: in groups of patients with brain injury (bi) and incomplete spinal cord injury (isci), a significant difference was found between measurements of both studies, concerning variation in alpha motoneuron reflex excitability during the application of joint mobilization techniques, with a decrease in the experimental group and an increase in the control group. in contrast, no significant differences were found after mobilization therapy. patients with complete spinal cord injury (csci) showed no significant differences in any measurements. conclusion: we demonstrate the effectiveness of passive movement in the decrease of muscle tone during the mobilization maneuver in patients with bi or isci, but no residual effect after completion of the trial. this research project showed no evidence regarding spasticity reduction in complete spinal cord injuries. this suggests that therapeutic interventions to decrease muscle tone, based on the passive exercise and stimulation of proprioceptors should be reconsidered.


Eligibility criteria:
inclusion criteria: * people over 18 years old * spasticity acquired after five years of age * any etiology * any location of the injury patients were instructed not to consume coffee, cigarettes or energy drinks 24 hours prior to the study nor participate in excessive physical exercise during the day.

Keywords: musculoskeletal manipulations muscle spasticity
abrogation of mitral regurgitation using the mitraclip system in high-risk patients unsuitable for surgery

Conditions: Mitral Regurgitation

Summary: the primary objective in this randomized trial is to evaluate the safety and efficacy of a mitraclip treatment in symptomatic patients with severe mitral regurgitation in comparison to the previous default medical treatment - in a study population who is not amenable for the conventional surgical approach as current gold standard.

the presence of a significant mitral regurgitation (mr) seriously effects the patient's quality of life and is associated with an increased mortality rate. the operative treatment of mr - either mitral valve repair or replacement - is the current gold standard. however mere half of the patients with a severe and symptomatic mr actually undergo an operative treatment (euro-heart-survey) due to restricted left ventricular ejection fraction, elderly patients with co-morbidities and high perioperative morbidity and mortality. in contrast, patients with severe and symptomatic mr not suitable for operation are treated with palliative medical therapy (heart insufficiency therapy). with the development of the mitraclip device - a minimal-invasive, percutaneous catheter-based technique - high-risk patients not suitable for surgery may receive a promising alternative treatment by approximating the mitral leaflets, thus creating a permanent leaflet coaptation and reducing or even abrogating the mr. the current data support the assumption of a safe and effective mr reduction with the mitraclip-system in inoperable high-risk patients with severe mr. but the feasibility still has to be proven in this special patient population.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * signed written consent * symptomatic patients (nyha-stadium ≥ iii) for at least 3 months with an exploited medical heart insufficiency therapy * increased perioperative risk with a logistic euroscore ≥ 15 or sts-score ≥ 15 * mr grade ≥ 2, amenable for mitraclip intervention assessed by an experienced interventional cardiologist * affirmation of in-operability by a "heart-team" consisting of either 1 cardiac surgeon and 1 cardiologist or 3 cardiologists exclusion criteria: * one essential cardiovascular event in the past 6 weeks; i. e. myocardial infarction, stroke, shock, cardiac decompensation, or the necessity of catecholamine therapy for haemodynamic stabilisation * implantation of a biventricular pacemaker-device for cardiac resynchronisation therapy in the past 3 months * solid tumor with a live expectancy \< 1 year

Keywords: severe mitral regurgitation interventional mitral valve reconstruction inoperable euroscore sts risk score mitraclip fluoroscopy echocardiography percutaneous treatment of mitral regurgitation