Kornimate/medical-research-clean huggingface dataset:
virological and clinical anti-hepatitis b virus (hbv) efficacy of tenofovir and emtricitabine in patients with hiv/hbv co-infection

Conditions: HIV Infections; Hepatitis B

Summary: this is a randomized multicentre trial of emtricitabine (ftc) versus tenofovir (tdf)/ftc in antiretroviral naive subjects with hiv/hbv co-infection over 48 weeks (clinical trial a). plus, a 12 week viral kinetic substudy comparing a subgroup of patients on clinical trial a is being conducted. (substudy a1)

this is a randomized multicentre trial of ftc vs tdf/ftc in antiretroviral naive subjects with hiv/hbv co-infection over 48 weeks (clinical trial a). plus, a 12 week viral kinetic substudy comparing a subgroup of patients on clinical trial a is being conducted. (substudy a1) primary objectives: * to compare the proportion of subjects with hbv dna levels below the limit of detection (\<400 copies/ml) by week 48 in each treatment group secondary objectives: * to evaluate the emergence of hbv resistance at 48 weeks * to compare the proportion of patients with undetectable hbv dna at weeks 12 and 24 in each treatment group * to compare the proportion of patients who achieve hbeag and hbsag seroconversion at weeks 12, 24 and 48 during the study * to compare changes in alt from baseline and the rate of hepatic cytolysis (alt\>5x uln) * to compare suppression of hiv-1 rna and changes in cd4/cd8 counts over 48 weeks * to compare the effect of therapy on histological changes in the liver and the presence of ccc-dna enrollment: * 24 patients in clinical trial a (of whom 16 enter substudy a1). clinical trial a: * patients with hiv/hbv co-infection who are naive to hiv/hbv therapy, have detectable hbv viraemia and are willing to start antiretroviral therapy. inclusion criteria: * written informed consent * documented hiv infection * age 18 - 70 years * hbv dna \> 106 copies/ml randomization: * arm 1: zidovudine (azt), emtricitabine (ftc), efavirenz (efv) * arm 2: tenofovir (tdf), emtricitabine (ftc), efavirenz (efv)

Eligibility criteria:
inclusion criteria: * written informed consent * documented hiv infection * age 18 - 70 years * hbv dna \> 10e6 copies/ml * alt \< 10 x uln (upper limit of normal) * creatinine \<= 2.0mg/dl * platelet count \>= 50,000/mm3 * hiv-1 therapy naive * no prior exposure to anti-hbv agents exclusion criteria: * hepatitis c viral rna (cv-rna) positive or anti-hepatitis a virus immunoglobulin m (hav igm) positive * acute hepatitis (serum alt \> 1000 u/l) * prior lam, tdf, or adefovir dipivoxil (adv) therapy * active opportunistic infection * pregnancy or lactation * other chronic liver disease * concurrent malignancy requiring cytotoxic chemotherapy * decompensated or child's c cirrhosis * alfa-fetoprotein (afp) \> 3x uln (unless negative computed tomography \[ct\] scan or magnetic resonance imaging \[mri\] within 3 months of entry date)

Keywords: hiv-1 hbv treatment tenofovir emtricitabine treatment naive hiv-1 infection hepatitis b virus infection
intraoperative neuromuscular monitoring and its impact on pre- and postoperative acoustic outcomes in thyroid surgery

Conditions: Thyroid Cancer; Thyroid Cancer, Papillary

Summary: this study examines the impact of intraoperative recurrent laryngeal nerve monitoring signal changes on the postoperative voice quality of thyroid surgery patients. by analyzing extensive surgical data and postoperative voice recordings, the investigation seeks to identify patterns in the variations of these signals and their correlation with voice quality outcomes. the goal is to enhance clinical understanding and surgical practices, allowing for more precise assessments of nerve function, informed surgical interventions, and improved postoperative patient well-being.

this research project conducts a detailed exploration into the fluctuations of intraoperative recurrent laryngeal nerve monitoring signals during thyroid surgery and their subsequent effects on the voice quality of patients after surgery. the study meticulously analyzes a comprehensive dataset comprised of surgical records and voice analyses conducted before and after the procedure. the primary objective is to pinpoint specific trends and changes in the nerve monitoring signals and to determine how these alterations correlate with the postoperative acoustic characteristics of patients' voices. by establishing a clear link between intraoperative signal dynamics and postoperative voice outcomes, the investigation aims to advance the field of thyroid surgery. this includes providing surgeons with critical insights for the precise evaluation of recurrent laryngeal nerve functionality, enabling targeted interventions during operations, and ultimately contributing to the enhancement of patients' quality of life following surgery. through this rigorous analysis, the study seeks to contribute valuable knowledge to the surgical community, facilitating improved patient care and outcomes in thyroid surgery.

Eligibility criteria:
inclusion criteria: * age 20-60 years old. * planned conventional unilateral thyroid lobectomy + isthmus resection + central compartment lymph node dissection. exclusion criteria: * history of past head and neck surgeries. * pronunciation system defect and disorder history. * history of vocal cord polyps or nodules. * history of upper respiratory tract infection in the 2 weeks before surgery or postoperative infection history. * history of neurological disorders. * abnormalities in the throat. * preoperative damage to throat morphology or motor function. * preoperative functional voice or language disorders, noticeable hoarseness, or difficulty in pronunciation. * pre- and postoperative laryngoscopic examination showing vocal cord paralysis and arytenoid joint dislocation. * neurological disorders causing abnormal throat function. * patient unable to cooperate with vhi (voice handicap index) assessment and voice spectrum examination.

Keywords: acoustic analysis thyroid cancer
the effect of patient counseling on adolescent hemophilia patient compliance with bleeding logs

Conditions: Hemophilia A; Hemophilia B

Summary: the study will see if counselling adolescents with severe or moderate hemophilia a or b results in increased compliance in the maintenance of bleeding logs.

the study will see if counselling adolescents with severe or moderate hemophilia a or b results in increased compliance in the maintenance of bleeding logs.to do this subjects will be randomized into a control group and a group who will receive consistent counselling by a pharmacist about their bleeding logs. the aims of the study are: * to provide a new method of bleeding and treatment documentation in the home setting (logs) to adolescent subjects with hemophilia a or b * to counsel these subjects about adherence to their treatment regimen prescribed by physician and the importance of keeping accurate documentation of each bleeding episode and its treatment. * to improve maintenance of logs, to allow for 1) assessment of bleeding frequency and treatment efficacy and 2) early detection of target joint bleeding and the potential need for prophylactic factor replacement.

Eligibility criteria:
inclusion criteria: * ages 12 through 20 * severe or moderate hemophilia a or b * self-infusing or transitioning to self infusion in the home setting * already assigned responsibility of monitoring bleeding logs exclusion criteria: * not meeting inclusion criteria

Keywords: bleeding logs factor infusions
fit in the aged by professional training

Conditions: Frailty; Sarcopenia

Summary: this intervention study tests training methods to stabilize or improve functionality in the high risk group of prefrail elderly persons.

this study aims at the improvement of muscular function by physical exercise in prefrail elderly persons. prefrail participants are recruited according to the frailty score of fried. taking into account, that vitamin d supplementation reduces falls and improves muscle strength in older people, all participants are supplemented by vitamin d. two different training methods are tested. after a run-in period of supplementation of vitamin d for two months, participants will be randomized into three different equally sized groups (n=25): group a will receive power training. group b will have progressive strength training. group c will serve as a control group. they will receive a consultation about leading a healthy life with special attention being paid to nutrition and physical activity. the intervention period lasts for 12 weeks. the 60 minutes training sessions will be held two times a week by members of the institute of sport science and sports of the university of erlangen-nuremberg. follow-up visits are scheduled three and six months after intervention period.

Eligibility criteria:
inclusion criteria: * prefrailty according to the frailty score of fried exclusion criteria: * sarcoidosis * nephrolithiasis * plasmacytoma * copd * inflammatory bowel disease * rheumatoid arthritis * history of cancer * instable heart disease * depression (gds\>=6) * dementia (mmse\<=24) * bmi\>35kg/m² * current attendance of muscle training * medication: immunosuppressive drugs

Keywords: muscle power frailty exercise vitamin d
hormonal status, performance and health in elite female athlete

Conditions: Healthy

Summary: the repercussions of the hormonal status of high-level sportswomen on their performance and health as well as on the athlete's biological passport (abp) have been little studied and remain poorly known. the investigators therefore propose to contribute to the improvement of current knowledge by determining, thanks to the implementation of a multidisciplinary monitoring, with the use of various tests and matrices, in female elite athletes and recreational athletes (control group): * 1) the impact of cycle phase, absence of cycle or contraceptive use on physical and psychological performance, health as well as on abp; * 2) the potential confounding effects of the athlete's environment * 3) correlations between the different matrices analyzed

volunteers to be studied: 80 healthy female subjects (16 to 30 years old), divided into 2 groups: group 1: 60 athletes, from different sports disciplines, in amenorrhea, with menstrual cycle or taking contraceptives group 2: 20 leisure sports subjects with menstrual cycle or taking contraceptives following the oral and written information of the project, the subjects have a minimum of 15 days of reflection before signing the written consent form. they will have the possibility, at any time, to voluntarily interrupt the study without having to justify themselves. investigations to be performed: 1. annual complete clinical examination : 2. "out-of-competition" follow-up, time frame 6 months * medical, nutritional and respiratory monitoring * biological monitoring * psychological monitoring * performance monitoring 3. non-invasive "in-competition" monitoring, only for group 1, once in a year on the day before/after a major competition: * biological monitoring * psychological monitoring * performance monitoring (interview)

Eligibility criteria:
inclusion criteria: * group 1: high-level athletes (qualified for national/international championships and/or training at least 15 hours/week) * group 2: recreational athletes who practice a regular physical activity exclusion criteria: * participation in another trial * history of cardiac pathology * high blood pressure * history of ulcers and other gastrointestinal disorders * myasthenia * renal insufficiency * person not affiliated or not benefiting from a social security system

Keywords: female elite athlete menstrual phase amenorrhea hormonal contraception performance health athlete biological passport
sucralose in subjects with diabetes mellitus insulin requesting

Conditions: Diabetes Mellitus, Type 2

Summary: to evaluate the acute effect of a preload of sucralose in presence of carbohydrate (hc) available on the glycemic response, postprandial c peptide and satiety in patients with type 2 diabetes mellitus (dm2) in intensive insulin therapy (iit).


Eligibility criteria:
inclusion criteria: * minimum period of six month intensive insulin therapy * prescription rapid insulin in the breakfast * aged 35 to 70 years * bmi 25 to 39.9 kg / m2 * hba1c lower than or equal to 10% (86 mmol / mol) * menopausal women under hormone replacement therapy exclusion criteria: * history of intolerance artificial sweetener sucralose * pregnant women * puerperal women * subjects with neurological disease, endocrine disorder no treatment, kidney disease stage iv or v, cancer, liver disease, chronic obstructive pulmonary disease, hiv * subjects with history of stroke , acute myocardial infarction and gastrointestinal resection

Keywords: glycemia satiety c peptide preload insulin
a study of lampalizumab intravitreal injections administered every two weeks or every four weeks to participants with geographic atrophy

Conditions: Geographic Atrophy

Summary: this multicenter, randomized, single-masked, sham injection-controlled study will investigate the exposure-response and safety of lampalizumab administered intravitreally every 2 weeks (q2w) or every 4 weeks (q4w) for 24 weeks in participants with geographic atrophy (ga) secondary to age-related macular degeneration (amd). a safety run-in assessment will be conducted prior to initiating enrollment in the randomized study.


Eligibility criteria:
inclusion criteria: * complement factor i (cfi) profile biomarker-positive result * women of child bearing potential and men should remain abstinent or use contraceptive methods exclusion criteria: * history of vitrectomy surgery, submacular surgery, or other surgical intervention for amd in study eye * previous subfoveal focal laser photocoagulation in study eye * laser photocoagulation in the study eye * prior treatment with external-beam radiation therapy or transpupillary thermotherapy in study eye * previous intravitreal drug administration in study eye. a single intraoperative administration of a corticosteroid during cataract surgery at least 3 months prior to screening is permitted * previous cell-based intraocular treatment in study eye * intraocular surgery in study eye * uncontrolled glaucoma and history of glaucoma-filtering surgery in study eye * history of corneal transplant in study eye * ga in either eye due to causes other than amd * proliferative diabetic retinopathy in either eye * active or history of neovascular (wet) amd in either eye * history of idiopathic or autoimmune-associated uveitis, ocular or intraocular conditions, and infectious or inflammatory ocular disease * active uveitis and infectious conjunctivitis, keratitis, scleritis or endophthalmitis * previous systemic treatment with complement inhibitor and with inhibitors/modulators of visual cycle * previous expression vector mediated intraocular treatments * uncontrolled blood pressure and atrial fibrillation * medical conditions associated with clinically significant risk for bleeding- * predisposition or history of increased risk for infection * active malignancy within the previous 12 months except for appropriately treated carcinoma in situ of cervix, resolved non-melanoma skin carcinoma, and prostate cancer with a gleason score of less than or equal to 6, and a stable prostate-specific antigen for greater than or equal to (\>/=) 12 months * history of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of lampalizumab injection * women of child bearing potential must have a negative serum pregnancy test within 28 days prior to initiation of study treatment * previous participation in other studies of investigational drugs
epigenetics in lupus nephritis

Conditions: Systemic Lupus Erythematosus; Lupus Nephritis

Summary: this is a translational study for the identification of epigenetic changes detectable in sera of patients suffering from systemic lupus erythematosus. the aim of the study is to analyze whether circulating dna fragments are 1) different in patients with or without lupus nephritis and 2) present and detectable in the circulation before the development of lupus nephritis.


Eligibility criteria:
inclusion criteria: * diagnosis of systemic lupus erythematosus according to the current classification criteria * a subgroup requires the presence of lupus nephritis (no restriction to specific ln histologic subtypes) exclusion criteria: * patients not able or unwilling to provide written informed consent

Keywords: epigenetics methylation toll-like receptors fibrosis
to study the effect of early cooling in acute subdural hematoma patients

Conditions: Subdural Hematoma, Traumatic

Summary: this randomized, prospective trial will study the effect of very early cooling in patients undergoing surgical evacuation of acute subdural hematomas (35°c prior to opening the dura followed by maintenance at 33°c for a minimum of 48h). intravascular cooling catheters (thermogard xp device, zoll) will be utilized to induce hypothermia or to maintain normothermia. the primary objective is to determine if rapid induction of hypothermia prior to emergent craniotomy for traumatic subdural hematoma (sdh) will improve outcome as measured by glasgow outcome scale-extended (gose) at 6 months.


Eligibility criteria:
inclusion criteria: * non-penetrating traumatic brain injury * glasgow coma scale (gcs) motor score ≤5 (not following commands) * estimated or known age 22-65 years * acute subdural hematoma requiring emergent craniotomy within 6 hours of initial injury * estimated time of injury to time to reach temp of 35°c\<6 hrs exclusion criteria: * total gcs = 3 and bilateral fixed and dilated pupils * following commands after an initial period of coma (gsc motor score of 6) * known pre-existing neurological deficit (e.g., previous traumatic brain injury (tbi), stroke) * concomitant spinal cord injury * arrival temperature is \<35°c * hemodynamic instability (i.e., mean arterial pressure (map)\<60 millimetres of mercury (mmhg) for 30 minutes) * active cardiac dysrhythmia resulting in hemodynamic instability * pregnancy * duret hemorrhage * prisoner or ward of the state * known history of clotting disorder (e.g., heparin induced thrombocytopenia, pulmonary embolism/deep venous thrombosis) * injury to other body organ where hypothermia would be precluded because of bleeding risk (e.g., grade 3 liver laceration; bowel laceration; flail lung or international normalized ratio (inr) \>1.4) * inability to obtain informed consent or utilize exception to informed consent for emergency research.

Keywords: subdural hematoma traumatic brain injury hypothermia
clarity imaging study

Conditions: Glaucoma

Summary: oct image quality is necessary to provide accurate diagnostic information to ophthalmologists. the increasing resolution of imaging techniques will require ever more high standards of optical transmission through the cornea and tear film. given that lubricant drops can improve optical transmission through the cornea, this study will attempt to quantify this. the primary objective is to assess the effect of cross-linked sodium hyaluronate on oct image quality compared to the effect of blinking alone.


Eligibility criteria:
inclusion criteria: * patients subjectively deemed to have poor image quality by the photographer exclusion criteria: * patients with a known adverse reaction to any of the constituents of the xlha * patients wearing contact lenses * patients who have used eyedrops in the past 2 hours

Keywords: glaucoma
study of the safety and efficacy of lyrica in the treatment of newly diagnosed partial epilepsy

Conditions: Epilepsy, Partial

Summary: the purpose of this study is to assess whether lyrica is a safe and effective treatment for partial epilepsy in comparison with an established treatment, lamictal.


Eligibility criteria:
inclusion criteria: * patients must be diagnosed with partial epilepsy and have experienced at least 2 partial seizures (simple partial, complex partial or partial seizure with secondary generalization) in the past year with one in the past 6 months. exclusion criteria: * treatable causes of seizures, for example identified etiologies including metabolic, neoplastic or active infectious origin. * primary generalized seizures.

Keywords: epilepsy partial seizures pregabalin monotherapy lamotrigine comparator double-blind and randomized trial
preventing opioid misuse through safe opioid use agreements between patients and surgical providers

Conditions: Opioid Use; Inguinal Hernia; Ventral Hernia

Summary: the effect of pain agreements to reduce opioid misuse is an accepted practice in many settings, but it has never been applied to the acute care setting. pain agreements are considered the standard of care for chronic pain management reliant on opioid prescribing, and they are a mandated component of care in many states. therefore, the adjunct of safe opioid use agreements into acute pain management offers a logical extension of current practices from chronic pain management. this study will test the use of agreements to improve safe opioid use to prevent misuse and opioid-related harm.


Eligibility criteria:
inclusion criteria: adult patients (at least 18 years of age), of any gender, who speak english or spanish, undergoing general surgery procedures with a high likelihood of receiving an opioid prescription (bariatric, inguinal hernia, or ventral hernia), who have their preoperative appointment at ut physicians health center at memorial hermann sugar land medical plaza, lyndon baines johnson, and bellaire exclusion criteria: patients with a known allergy or contra-indication to opioids, pregnancy, signification cognitive impairment, history of opioid misuse/abuse, chronic opioid use, readmission before the follow up appointment
velcade,rituximab,cyclophosphamide and decadron

Conditions: Lymphoma, Non-Hodgkin; Lymphoma, B-Cell

Summary: overall response rate and time to disease progression using this regimen in patients with low-grade b-cell non-hodgkin's lymphoma.

this is a phase ii open label study that is looking at the vrcd combination regimen in patients with previously untreated low-grade non-hodgkin's lymphoma. treatment will start by combining oral dexamethasone and cyclophosphamide with intravenous velcade, rituximab. chemotherapy cycles will be given as outlined below every 35-days and will continue until two cycles beyond complete remission (cr), toxicity, patient's withdrawal, disease progression, or a maximum of 8 cycles.

Eligibility criteria:
inclusion criteria: * small lymphocytic lymphoma * follicular cell lymphoma (grades i and ii) * mantle cell lymphoma patients that are not considered eligible for high-dose therapy and stem cell transplant * lymphoplasmacytic lymphoma including waldenstrom's macroglobulinemia * marginal zone lymphoma * malt lymphoma that has only failed antibiotic therapy or involved field radiation. * adequate bone marrow function, renal function, and hepatic function as outlined in details below. * ecog performance status of 0, 1, or 2 * able to read, understand, and sign an irb approved informed consent exclusion criteria: * known hiv positive status * known cns involvement * prior therapy for lymphoma excluding antibiotic treatment for malt-type nhl.

Keywords: nhl