Kornimate/medical-research-clean huggingface dataset:
clinical trial to assess the effect of the change of efavirenz (efv) for lopinavir/ritonavir (lpv/r) in lipoatrophy in hiv-infected patients

Conditions: HIV Infections; Lipoatrophy

Summary: eligible hiv-infected patients with clinically evident lipoatrophy despite treatment with efavirenz and fixed-dose combination of thymidine nucleoside analogues will be informed and asked to enroll in the study; will be randomized (1:1) into two branches, a: efv + fixed combinations of analogue tenofovir + emtricitabine.b (experimental): lpv/r + combination of correspondent analogues. the main variable is the evaluation of the absolute change in limb fat mass at 24 months from baseline in both groups.


Eligibility criteria:
inclusion criteria: * patients hiv positive \> 18 years. * patients in treatment with sustiva(r)+truvada(r); or sustiva (r)+kivexa(r). * hiv-arn \< 50 copies/ml in the las six months. * clinically evident lipoatrophy (moderate or severe). * negative pregnancy test. * signed informed consent. exclusion criteria: * evidence of failure or mutation to therapy with protease inhibitors. * patients that can not be treated with lpv/r. * mild lipoatrophy. * history of alcoholism or drug addiction that discourages participation in the study. * pregnancy or breastfeeding. * documented current or 4 weeks prior opportunistic infection. * creatinin clearance \< 60ml/min. * concomitant use of nephrotoxic drugs or immunosuppressants. * actual treatment with systemic corticosteroids, il-2 or chemotherapy. * patients under treatment with other drugs in investigation. * acute hepatitis. * any other disease that discourages participation.

Keywords: hiv - lipoatrophy treatment experienced
study of sargramostim in moderately to severely active crohn's disease

Conditions: Crohn's Disease

Summary: the purpose of this study is to assess the tolerability, pharmacokinetics and safety of 2 and 6 micro g/kg/day sargramostim administered subcutaneously once daily for 4 weeks, and to assess the efficacy and safety of 6 micro g/kg/day sargramostim administered subcutaneously once daily for 8 weeks in comparison with placebo, in patients with moderately to severely active crohn's disease.

on 29 may 2009, bayer began transitioning the sponsorship of this trial to genzyme. note: this study was originally posted by sponsor berlex, inc. berlex, inc. was renamed to bayer healthcare, inc.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of crohn's disease (endoscopic or radiological evaluation) at least 4 months prior to receiving the first dose of study drug * moderately to severely active crohn's disease at time of screening (i.e., crohn's disease activity index \[cdai\] \>220 and \<475 points) exclusion criteria: * colostomy or ileostomy * immediate need for gastrointestinal (gi) surgery for active gi bleeding, peritonitis, intestinal obstruction, or intra-abdominal or perianal abscess requiring surgical drainage * gi surgery within 6 months prior to receiving the 1st dose of study drug * symptoms of bowel obstruction or confirmed evidence of a clinically-significant stricture within the last 6 months that has not been surgically corrected

Keywords: crohn's disease sargramostim cdai moderately to severely active crohn's disease
assessment of emotional memory during transient global amnesia

Conditions: Amnesia, Transient Global

Summary: there are few studies on the role played by emotions in transient global amnesia (tga), in particular with regard to their impact on the functioning of memory. the study investigators wish to better understand the link between episodic memory, emotional state and psychogenic factors during tga. it would be interesting to see if the patients suffering from tga triggered by a psychological shock process emotional information differently from those whose tga was triggered by an "organic" shock (physical effort, trauma, etc.). finally, amnesic stroke is a good model for better understanding the function of the hippocampus, in particular of the ca1 region, in episodic memory.


Eligibility criteria:
inclusion criteria: * subject with no history of transient global amnesia or neurological or psychiatric pathology. * patients with a transient global amnesia according to the criteria of hodges and warlow (1990) in the acute phase (i.e. within 24 hours after the onset of the stroke), accompanied by a trusted person * the patient must have given their free and informed consent and signed the consent form * the patient must be a member or beneficiary of a health insurance plan exclusion criteria: * the subject is participating in another study, or is in a period of exclusion determined by a previous study * the subject refuses to sign the consent * it is impossible to give the subject informed information * the patient is under safeguard of justice or state guardianship * the patient is pregnant or breastfeeding * presence of a focal neurological pathology that may explain the symptoms, history of epilepsy or psychiatric disorders. * hypersensitivity to iodinated contrast media. * known allergy to 18-fdg. non-inclusion criteria concerning control subjects: * presence of disorders on neurological assessment * presence of cognitive disorders on the neuropsychological assessment (z-score \<-1.65 on the rbans or on the stroop test). exclusion criteria for the target population: • patients will be excluded after the 1st neuropsychological assessment if episodic memory tests show complete recovery from anterograde amnesia.
comparing antipsychotic medications in lbd over time

Conditions: Parkinson's Disease Psychosis; Dementia With Lewy Bodies

Summary: the primary objective of this study is to determine whether treatment with pimavanserin or quetiapine is associated with a greater improvement in psychosis when used in a routine clinical setting to treat hallucinations and/or delusions due to parkinson's disease (pd) or dementia with lewy bodies (dlb) - collectively referred to as lewy body disease (lbd).

psychosis (hallucinations and delusions) is a common problem in parkinson's disease (pd) and dementia with lewy bodies (dlb). pd is a common neurodegenerative disorder that causes movement, cognitive, and psychiatric symptoms. dlb is a similar disorder, though causes more severe cognitive and psychiatric problems. psychosis is highly prevalent among people with pd and dlb, often manifesting as visual hallucinations or paranoid delusions. up to 60% of people with pd will experience psychosis over the course of their disease. psychosis is associated with increased mortality, caregiver burden, and poorer quality of life. more study is needed to determine the best way to treat psychosis in pd and dlb. currently, both quetiapine and pimavanserin are used in clinical practice for psychosis in pd and dlb. however, few comparison studies have been done and it is unclear if one medication is superior to the other. this will be a clinical trial comparing quetiapine and pimavanserin among patients with psychosis due to pd or dlb requiring initiation of a medication. patients will be randomized to quetiapine or pimavanserin and improvement in psychosis at 6 months will be compared between the groups.

Eligibility criteria:
inclusion criteria: * patients seen in the neurology clinic at ut health san antonio * diagnosed with psychosis due to pd or dlb * requiring initiation of an antipsychotic medication * clinical equipoise between quetiapine and pimavanserin must exist * the prescribing provider must be comfortable prescribing and managing both quetiapine and pimavanserin exclusion criteria: * medical contraindication to either medication * caregiver unavailable to complete npi-q * currently taking an antipsychotic medication * prescribing provider unwilling to manage either medication

Keywords: quetiapine pimavanserin psychosis hallucinations delusions
optimizing health related quality of life measurement in adolescent and young adult oncology

Conditions: Malignant Solid Neoplasm; Hematopoietic Neoplasms; Lymphatic System Neoplasm

Summary: this study evaluates how adolescent and young adults with cancer in the u.s. and their loved ones respond to questions that will later be used with people who may have cancer and other chronic health conditions

primary objectives: * to refine patient-reported outcome assessment tools of body image, fertility, and financial burden for promis and evaluate assumptions for irt consistent with promis scientific standards (e.g., unidimensionality, local independence). * to examine item-level properties to support computer adaptive testing and evaluate possible differential item functioning (dif). secondary objective * to create short forms and examine convergent validity of the new body image, fertility, and financial burden short forms and item banks with corresponding legacy measures of those constructs. outline: this is an observational study. participants complete surveys on study.

Eligibility criteria:
inclusion criteria: ayas with a cancer history: * ayas will be eligible for this sample if they: * are 15 to 39 years of age * were first diagnosed with cancer at 15 to 39 years of age * are able to read and understand english * live in the united states * have a new cancer diagnosis and are receiving curative treatment or are currently 0 to 10 years post-treatment. ayas without a cancer history: ayas will be eligible for this sample if they: * are 15 to 39 years of age * are able to read and understand english; and * live in the united states. caregivers of ayas with cancer: * caregivers of ayas will be eligible for this sample if they: * are 18 years of age or older * are able to read and understand english * live in the united states * have a child/ward/partner for whom they have provided care, and * their child/ward/partner is 15 to 25 years of age and meets the other eligibility criteria as an aya participant with a cancer history (described above). exclusion criteria: ayas with a cancer history: ayas will be excluded if they (1) were diagnosed with basal cell skin cancer; or (2) are currently receiving hospice care. ayas without a cancer history: aya patients will be excluded if they (1) have ever been diagnosed with cancer; or (2) are currently receiving hospice care.
the use of pedi_ eat 10 score versus nurse performed screening in the assessment of post extubation dysphagia

Conditions: Pediatric Post Extubation Dysphagia

Summary: invasive mechanical ventilation is one of the most common interventions in critically ill patients, and is invariably characteristic, if not defining, of icu therapeutic regimen much attention has been paid to complications occurring during and because of mechanical ventilation, such as nosocomial infections, delirium, and critical illness neuropathy and myopathy. however, an often underappreciated and minimally explored complication of mechanical ventilation is post-extubation dysphagia .

invasive mechanical ventilation is one of the most common interventions in critically ill patients, and is invariably characteristic, if not defining, of icu therapeutic regimen much attention has been paid to complications occurring during and because of mechanical ventilation, such as nosocomial infections, delirium, and critical illness neuropathy and myopathy. however, an often underappreciated and minimally explored complication of mechanical ventilation is post-extubation dysphagia . post-extubation dysphagia (ped) is defined as the difficulty or inability to effectively and safely transfer food and liquid from the mouth to the stomach after extubation. as reported by malandraki et al ped is more common in pediatric patients with an overall incidence of 29% and exceeds the 23% incidence reported in adults, another australian context showed that 41% of critically-ill pediatric patients requiring endotracheal intubation eventually evolved ped with one-third of those patients experiencing silent aspiration. using a prior pioneering prospective study of mechanically ventilated patients, zuercher et al evaluated 933 extubated patients, of which 116 were screened for the presence of post-extubation dysphagia. they analyzed pre-intubation characteristics to derive factors possibly associated with development of ped, and found that pre-existing neurological disease, emergency admission, increased duration of mechanical ventilation, increased duration of renal replacement therapy, and higher severity of illness were associated with development of post- extubation dysphagia. interestingly, increased bmi was associated with lower incidence of dysphagia. because of the significant negative impact of post-extubation dysphagia on outcomes of pediatric patients, early identification and intervention are crucial. the scientific description of the phenomenon of post-extubation dysphagia in pediatric populations as a distinct pathological entity from the phenomenon in adult populations is considered a corner stone in the systematic exploration of the phenomenon . such systematic exploration has, to date, been limited...

Eligibility criteria:
inclusion criteria: * all pediatric patients admitted to picu and needed mechanical ventilation exclusion criteria: * patient admitted to picu but not neeed mv
study comparing the safety and efficacy of tigecycline with ampicillin-sulbactam or amoxicillin-clavulanate to treat skin infections

Conditions: Skin Diseases, Bacterial

Summary: the purpose of this study is to compare the safety and efficacy of the antibiotic tigecycline with other antibiotics, ampicillin-sulbactam, and amoxicillin-clavulanate in the treatment of a complicated skin and/or skin structure infection (csssi).


Eligibility criteria:
inclusion criteria: * clinical diagnosis of complicated skin or skin structure infection * male or female, 18 years or older * need for intravenous treatment for 4 to 14 days exclusion criteria: * skin infection that can be treated by surgery \& wound care alone * diabetic foot ulcers or bedsores where the infection is present longer than 1 week * poor circulation such that amputation of the infected site is likely within a month other exclusions apply

Keywords: skin infection antibiotics
cost-utility analysis hospital versus home in multiple myeloma

Conditions: Multiple Myeloma

Summary: bortezomib needs repetitive visits at hospital for injections. hospital-at-home (hah) might be an attractive and suitable alternative in this situation. this study aim to perform a cost-utility analysis of two different strategies in several hah structures within the grand est region in france.

bortezomib is a standard therapy of newly-diagnosed multiple myeloma and is also approved for relapsing disease, requiring the patients to travel to the outpatient-hospital (oh) once a week for several months. hospital-at-home (hah) might be an attractive and suitable alternative in this situation. this study aim to perform a cost-utility analysis of two different strategies in several hah structures within the grand est region in france: exclusive hospital-based bortezomib administration versus combined administration in both oh and hah.

Eligibility criteria:
inclusion criteria: * minimum age 18 * enrolled in a social security scheme * diagnosis of multiple myeloma in first line or relapse * treatment plan including bortezomib, adopted in a multidisciplinary meeting in a department of hematology in nancy (main investigator), reims, strasbourg university hospitals or metz-thionville and mulhouse local state-run hospitals * the patients must have agreed to the treatment protocol and to take iv or po associated drugs prescribed in addition to bortezomib * the patients must meet the 2003 eligibility criteria of the national agency for accreditation and evaluation in health (anaes) for chemotherapy at home: * absence of severe adaptive or psychological disorders, ability to understand the protocol * absence of cognitive impairment * availability and agreement of the attending physician * home safety and hygiene * do not decline to participate in the research and share their personal data exclusion criteria: * already participating in another trial * have a follow-up and/or treatment for another condition requiring a particular care during the bortezomib treatment period
early arthroscopic stabilization versus rehabilitation of the shoulder in adolescents with a traumatic first-time anterior shoulder dislocation episode

Conditions: Shoulder Dislocation

Summary: each year within canada and the us, more than 30,000 children and adolescents will have an injury to their shoulder resulting in a shoulder dislocation. although the current practice is to manage this initial dislocation without surgery, the vast majority of these children and adolescents will, unfortunately continue to have instability episodes of their shoulder. recurrent instability can cause damage to the bones and cartilage that form the shoulder resulting in potentially more difficult surgical stabilization, and possibly long-term sequela. to that effect, there is increasing interest to consider early surgical stabilization in this population. this pilot randomized controlled trial (rct) will evaluate the feasibility of conducting a larger rct assessing the effect of early arthroscopic stabilization compared to rehabilitation on the rate of repeat shoulder dislocations (recurrent instability), pain, and shoulder function among adolescents (aged 12-18 years) with first-time shoulder dislocations. these patients will be followed for one year.


Eligibility criteria:
inclusion criteria: 1. males and females between the ages of 12 and 18, inclusive 2. patients with a first-time traumatic anterior glenohumeral dislocation within the past 3 months 3. anterior glenohumeral dislocation confirmed by radiography, reduction required by medical personnel, or demonstration of anterior apprehension on physical examination following injury to the shoulder 4. mri or mra demonstrating disruption of the glenohumeral soft tissues (including the labrum, periosteum, or inferior glenohumeral ligament) relating to instability 5. patients who have the ability to speak, understand, and read english 6. provision of informed consent (age 18) or parental consent (ages 12-17, inclusive) 7. provision of informed child assent (ages 12-17, inclusive) exclusion criteria: 1. previous dislocation episodes or instability of the affected shoulder 2. previous surgeries involving the affected shoulder 3. history or clinical exam findings of generalized ligamentous laxity (defined as a beighton score of 4 or more points) 4. history of multi-directional instability of either shoulder 5. concomitant fracture of the tuberosity, humerus, or glenoid (excluding a bankart or hill sachs lesion) 6. bony bankart lesion exceeding 15% of the glenoid surface (using the best-fit circle method on mri) 7. hill sachs lesion exceeding 15% of the humeral diameter (measured on transaxial slice of mri similar to salomonsson et al.) 8. a neurological injury of the affected arm 9. patients who will likely have problems, in the judgement of the investigator, with maintaining follow-up 10. any other reason(s) the investigator feels is relevant for excluding the patient
neurological impact of vascular events in noncardiac surgery patients cohort evaluation pilot study

Conditions: Perioperative Stroke

Summary: two hundred million adults worldwide have major surgery every year. a million of these patients will have an obvious stroke after their surgery. another 10 million patients may have "silent" strokes. although silent strokes are not diagnosed immediately, they are likely to reduce patients' short-term memory, concentration, and ability to function at home. however, the investigators do not know how common silent strokes are after noncardiac surgery, nor the extent to which they affect brain function. the investigators will first perform a pilot trial to determine the feasibility of the larger study that will provide the definitive answer to this question. participating patients will be assessed by questionnaire before and after surgery, and will have a magnetic resonance imaging (mri) study of the brain after the surgery to look for silent strokes. combining the results of the mri and the questionnaires will allow us to determine the frequency of silent strokes after non-cardiac surgery, and their effect on brain function. the neurovision pilot study will determine the feasibility of a large study to examine the frequency and the impact of silent stroke in patients who undergo noncardiac surgery.


Eligibility criteria:
inclusion criteria: * age 65, * undergoing noncardiac surgery, * regional or general anesthetic. exclusion criteria: -patients who have a contraindication to mri.
study of a cox-2 inhibitor for prevention of ovulation

Conditions: Rupture; Graafian Follicle

Summary: in this study the investigators propose to evaluate a cox-2 inhibitor(meloxicam) to assess its effect on follicular development and find out if this regimen delays or blocks ovulation while maintaining ovarian cyclicity. the investigators intend to administer 15 mg or 30 mg of meloxicam per day for 18 days starting on day 5 after onset of menses during 3 continuous cycles. the 3 treatment cycles will be preceded and followed by control cycles with no treatment. ovulation or lack there of will be monitored by transvaginal ultrasound examinations (tvus), estradiol, luteinizing hormone (lh), and progesterone levels in multiple blood samples in each cycle. the investigators will recruit a total of 56 women. each woman will be randomly assigned to 1 of the 2 dose regimens of meloxicam, with 28 women assigned to each of the 2 dose regimens. participating women will demonstrate an ovulatory cycle before starting meloxicam treatment and will be protected from pregnancy by prior sterilization.

in a recent study, following follicular development by daily ultrasound examinations in 22 women, meloxicam was administered when the dominant follicle reached a diameter of 18 mm (jesam, salvatierra et al. 2010). results from this study indicate that meloxicam 30 mg given for five days in late follicular phase was more effective at delaying follicular rupture than 15 mg. follicular rupture was delayed more than 48 hours in 11/22 (50%) volunteers in the group treated with 15 mg/day and in 20/22 (91%) volunteers in the group treated with 30 mg/day.

Eligibility criteria:
inclusion criteria: * healthy * proven fertility in the past * 18- 40 years old * regular menstrual cycles in the past 3 months (24-35 days) * surgically sterilized * non-lactating * hemoglobin of at least 11 g/dl * willing to give informed consent in writing exclusion criteria: * allergy to meloxicam, aspirin, or other nsaids * currently pregnant or breast feeding * history of gastrointestinal problems like stomach ulcer, bleeding or bowel problems * history of heart attack, stroke, or blood clot * hemorrhagic or coagulation disorders * known liver and renal disorder * history of or signs and symptoms of cancer, hyperprolactinemia, bloody breast discharge, diabetes, or any endocrine disturbance * history of asthma, skin or mucosal allergies * hypertension: systolic blood pressure \> 135 mm hg or diastolic blood pressure \>85 mmhg * history of mental illness including depression or epilepsy * cigarette smoker * habitual user of anti-inflammatory drugs * alcoholism or any drug abuse * use of anticoagulants or steroids

Keywords: ovulation unruptured luteinized follicle meloxicam