Kornimate/medical-research-clean huggingface dataset:
mk0518 in the treatment of hiv-infected patients switched from a protease inhibitor regimen (0518-033)(terminated)

Conditions: HIV Infection

Summary: the purpose of this study is to investigate the efficacy, safety, and tolerability of an investigational treatment for patients with human immunodeficiency virus (hiv).


Eligibility criteria:
inclusion criteria: * patient is at least 18 years of age * patient is human immunodeficiency virus (hiv) positive * patient has documented human immunodeficiency virus (hiv) ribonucleic acid (rna) \<50 copies/milliliter (ml) for at least 3 months while on a kaletra based regimen * patient has been on a kaletra based regimen for at least 3 months without a change in background antiretroviral therapy * patient has no documentation of hiv rna \>50 copies/ml for at least 3 months while on the kaletra based regimen exclusion criteria: * patient is or plans to become pregnant, or is nursing a child * patient plans to donate eggs or impregnate/donate sperm * patient is receiving stavudine (d4t) as a component of the background antiretroviral therapy * patient is currently receiving a second protease inhibitor in addition to kaletra * patient is currently receiving, or has received in the past twelve weeks, treatment for the management of elevated lipids * patient has used another experimental hiv-integrase inhibitor * patient has a current (active) diagnosis of acute hepatitis due to any cause

Keywords: treatment experienced
early and intensive occupational therapy in mechanical ventilated patients

Conditions: Critical Illness; Ventilator Lung; Impairment, Cognitive; Impairment, Coordination

Summary: this study evaluates the efficacy of an early and intensive occupational therapy (ot) protocol in critical adult patients requiring mechanical ventilation. evaluating the functional independence at hospital discharge.

a randomized clinical trial with an experimental-control will be implemented, considering the prospective multicenter group, with parallel groups, in a 1:1 ratio, in 3 chilean hospitals. a control group will has a standard analgesia, sedation, delirium and mobilization (asdm) measures or an intervention group will have early and intensive ot plus asdm. the intervention group will receive 20 ot sessions, mainly twice a day, which considers a predefined protocol of actions according to the patient's condition

Eligibility criteria:
inclusion criteria: * age equal to or greater than 18 years. * need for hospitalization in icu. * at least 12 h of invasive mechanical ventilation * informed consent signed by legal representative and / or patient. exclusion criteria: * known cognitive impairment before admission with short iqcode (informant questionnaire on cognitive decline in the elderly) scores\> 3.3 were excluded. * previous functional impairment, faq (functional activities questionnaire) defined as \> 6 points. * severe communication disorder and cultural limitation of language (language different from spanish) * patient with limited therapeutic proportionality. * neurocritical patients (moderate-severe traumatic brain injury / stroke of some kind / among others) * spinal injury or unstable fractures that limit mobilization
comparison between oral and enema of chloral hydrate

Conditions: Congenital Cataract

Summary: to compare the clinical sedative effect and safety using 10% chloral hydrate during ophthalmic examinations for oral vs enema group.the patients were randomly divided into two groups (oral group and enema group) using a computer random number generator with a 1:1 allocation (simple randomization, odd number for oral group and even number for enema group).

to compare the clinical sedative effect and safety using 10% chloral hydrate during ophthalmic examinations for oral vs enema group.the patients were randomly divided into two groups (oral group and enema group) using a computer random number generator with a 1:1 allocation (simple randomization, odd number for oral group and even number for enema group).one hundred and twenty children aged from 3 to 36 months (5-15 kg) scheduled to ophthalmic examinations were randomly sedated by oral chloral hydrate(80 mg×kg-1, n = 60) or enema chloral hydrate(80 mg×kg-1, n = 60). the primary endpoint was successful sedation to complete the examinations including slit-lamp photography, tonometry, anterior segment analysis, and refractive error inspection. the secondary endpoints included onset time, duration of examination, recovery time, discharge time, any side effects during examination, and within 48 h after discharge.

Eligibility criteria:
inclusion criteria: * diagnosed with congenital cataract aged from 3 to 36 months weight from 5 to 15 kg with american society of anesthesiologists (asa) physical status 1-2 exclusion criteria: * with gastro-esophageal reflux, nausea and vomiting, apnea in the past 3 months recent pneumonia exacerbation of asthma, bronchitis and upper respiratory tract infection bradycardia, and facial abnormalities, allergy to chloral hydrate, weight \ 20 kg .

Keywords: pediatric ophthalmic examination chloral hydrate effects comparison
measuring the context of healing in chronic pain treatment

Conditions: Chronic Pain

Summary: this project focuses on whether nonspecific factors as well as patient characteristics contribute to treatment outcome differences. the project uses assessment instruments, computerized adaptive tests (cats), from the patient-reported outcomes measurement information system (promis®). the research team has recently developed and tested (using promis methods) a set of instruments to assess non-specific factors in healing from the patient's perspective. these instruments, the healing encounters and attitudes lists (heal) assess the patient-provider connection, treatment expectancy, views of the healthcare environment, positive and negative attitudes, spirituality, and attitude toward complementary and alternative medicine (cam). heal cat's, like other promis cats, are brief, easy to use and understand, and are designed to apply to a broad spectrum of treatments and health conditions. in this project, the investigators aim to 1) evaluate whether heal predicts chronic pain treatment outcomes, 2) examine heterogeneity of treatment effects based upon heal and promis scores in integrative and conventional medicine settings, and 3) interview patients and their clinicians regarding the utility of heal, promis and a pain log for enhancing communication. the investigators will administer heal cats and other promis cats (depression, anxiety, sleep disturbance, fatigue and physical function) to 200 patients who are starting treatment for chronic pain in integrative medicine and conventional medicine settings. follow-up assessments will be completed 2 and 4 months after baseline testing. the investigators will evaluate factors that may predict which patients judge themselves to be improved, the same, or worsened. some of the possible factors that may contribute to improvement include heal scores, emotional distress, or the preference for cam or conventional treatment. the investigators are also interested in learning whether patients find the assessments to be clear and useful. a subset of 50 patients and approximately 10 clinicians will complete interviews about the heal and promis questions, and about the pain log developed by a patient advocacy group partner, the american chronic pain association. by interviewing patients and their healthcare providers, the investigators hope to determine the clarity and acceptability of the heal and other assessments, and to learn whether heal and promis summaries enhance patient-provider communication in the clinical partnership.


Eligibility criteria:
inclusion criteria: * 18 years and older * able to read and understand english * able to answer questionnaires on a computer * starting a new treatment for chronic pain or having just started a new treatment within the past month * expecting to continue their course of treatment exclusion criteria: * psychotic disorders * substance abuse by self report
the comparative effectiveness of telemedicine to detect diabetic retinopathy

Conditions: Diabetic Retinopathy

Summary: this project aims to: 1) evaluate the long-term effectiveness of telemedicine to detect diabetic retinopathy when compared to traditional surveillance methods, 2) identify the health belief factors related to adherence with annual diabetic eye exams, and 3) determine the cost-effectiveness of the telemedicine system from the perspective of the community clinic, the third-party payer, and the individual patient.


Eligibility criteria:
inclusion criteria: * diabetic, at least 18 years old, patient at a participating health clinic

Keywords: diabetes diabetic retinopathy screening ophthalmic telemedicine comparative effectiveness research
registry of congenital dyserythropoietic anemia

Conditions: Congenital Dyserythropoietic Anemia

Summary: congenital dyserythropoietic anemia is a heterogeneous inherited disease. hyperplasic erythropoiesis is ineffective and associated with morphological abnormalities of some of the erythroblasts that form the basis of cytological classification. the cumulative incidence is not very clear, but varies between countries from 0.08 million in scandinavia to 2.6 cases/million inhabitants in italy where it appears to be the most reported. the common manifestation is moderate chronic congenital anemia. this anaemia is either normocytic or discreetly macrocytic, non-regenerative or inappropriate regarding anaemia, contrasting with signs of hemolysis with moderate unconjugated hyperbilirubinemia. diagnosis is usually made in the pediatric period, but because of the great heterogeneity, the diagnosis sometimes may be delayed. splenomegaly and jaundice are mostly present. secondary hemochromatosis is common in the absence of transfusion due to hyper-intestinal absorption of iron induced by the dyserythropoiesis. the transmission mode for type i and ii is autosomal recessive, while it is autosomal dominant or sporadic for type iii. several clinical questions remain concerning this disease : * the median survival of patients is not well known, neither the causes of death * benefit/risk of splenectomy * iron overload quantification and consequences the idea is to stablish a french registry of congenital dyserythropoietic anemia in order to help to understand the correlation between phenotype and genotype of this disease.


Eligibility criteria:
inclusion criteria: * patient with confirmed cda * no opposition to the use of health data for research purposes exclusion criteria: * patient opposed to participate in the study

Keywords: congenital dyserythropoietic anemia french registry
safety of purified meningococcal vaccine with serogroups acwy, in 3,000 filipino subjects aged > 2 years

Conditions: Infections, Meningococcal

Summary: glaxosmithkline philippines has submitted a registration file for its purified meningococcal polysaccharide of serogroup acwy vaccine (mencevax acwy). this study is being conducted to collect clinical data in the local target population in order to assess the occurrence of rare adverse events after vaccination as per the requirement of philippines bureau of food and drugs directive.

all subjects will receive a single dose of gsk biologicals' mencevax acwy vaccine according to the prescribing information. subjects will be stratified into the following age groups: 2 to 5 years 6 to 17 years \> 18 years the protocol posting has been updated in order to comply with the fda amendment act, september 2007.

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that they and/or their parent/guardian can and will comply with the requirements of the protocol. * a filipino male or female \> 2 years of age at the time of the first vaccination. * free of obvious health problems as established by medical history and clinical examination before entering into the study. * written informed consent obtained from the subject and/or from the parent/ guardian of the subject. exclusion criteria: * subjects suffering from acute severe febrile illness. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * major congenital defects or serious chronic illness. * history of any neurologic disorders or seizures. * pregnant or lactating female. * female planning to become pregnant. * history of chronic alcohol consumption and/or intravenous drug abuse. * any contraindications as stated on the prescribing information.

Keywords: safety meningococcal disease meningitidis serogroups a, c,w & y diseases meningococcal vaccine
assessment of invasive mediastinal staging in cn1 lung cancer.

Conditions: Non-small Cell Lung Cancer

Summary: this is a prospective non-randomized multicenter clinical trial performing endobronchial and esophageal ultrasound for mediastinal lymph node staging of operable and resectable ct1-t2-selectedt3 cn1 cm0 nsclc.

provided no mediastinal lymph node metastases are proven by echoendoscopy, all patients will subsequently undergo surgical staging. patients without tissue proof of mediastinal nodal disease at surgical staging will undergo a thoracotomy with systematic lymph node dissection. provided mediastinal lymph node metastases are proven by echoendoscopy, the patient goes off study protocol and can further be assessed/treated according to local clinical practice.

Eligibility criteria:
inclusion criteria: * patients with operable and resectable (suspected) nsclc * patients with clinical n1 staging based on pet/ct * only t1, t2, and selected t3 (i.e. intraparenchymal tumour \>7cm, chest wall, or additional nodule in the same lobe) are allowed. exclusion criteria: * patients with enlarged mediastinal lymph nodes on chest ct or fdg-pet positive mediastinal lymph nodes * patients with a central tumour staged t3 or any t4. * all stage iv patients. * patient unable to give informed consent. * patient previously underwent a mediastinoscopy. * tracheal or upper airway stenosis.

Keywords: invasive staging mediastinal lymph nodes endosonography surgical staging lung cancer
global response during infusion of a gel with levodopa/carbidopa

Conditions: Parkinson's Disease

Summary: this multicenter, post marketing observational study (pmos) was designed to evaluate the long-term effectiveness of levodopa/carbidopa intestinal gel (duodopa) on motor fluctuations (duration of off periods) in participants with advanced levodopa-responsive parkinson's disease (pd) and severe motor fluctuations and hyper-/dyskinesia (involuntary movements). secondary objectives of this study were to assess the participants' quality of life; to assess the long-term safety of duodopa; to assess disability, cognitive function, and non-professional caregiver burden; and to assess the economic and social impact of family caregiver assistance.

male or female participants ages 18 years of age who were already on duodopa treatment and had concluded the naso-intestinal phase were included in this study. duodopa was administered via a portable pump directly into the proximal small intestine via a percutaneous endoscopic transgastric jejunostomy (peg-j) tube. there were 3 planned visits during the study: enrollment (visit 1), 1 year (visit 2), and 2 years (visit 3).

Eligibility criteria:
inclusion criteria: * participants already on treatment with duodopa (having already concluded the naso-intestinal treatment phase) according to the local duodopa product label and to routine clinical care for advanced pd patients * participants with available data on duodopa treatment, on previous pd conventional treatments and with at least one of the scales/questionnaires under study already collected on the participant's clinical chart * participant or legal representative has given written informed consent * non-professional caregiver (relative or familiar who give daily assistance to the patient) has given his/her written consent exclusion criteria: • history or presence of any condition that might interfere with the long-term continuation of the duodenal infusion of duodopa

Keywords: caregiver quality of life parkinson's disease
development of a noninvasive method of evaluation of pulmonary inflammation in the condensates of exhaled air

Conditions: Bronchopulmonary Ignition; Condensate of Exhaled Air; Mucoviscidosis; Asthma

Summary: the aim of the study is identify biological parameters reflecting proteolytic activity in the exhaled condenstaes which might be useful to follow up pulmonary inflammation in various conditions including cystic fibrosis, copd, asthma, tobacco exposure. three proteases will be analyzed, i.e. elastase, proteinase 3 and cathepsin g. results in the condensates will be compared to those obtained in sputum.

5 groups of 20 individuals each: group 1 cf, group 2 copd, group 3 asthma, group 4 tobacco exposure, group 5 control subjects. collection of exhaled condensates in all subjects and of sputum in subjects belonging to groups 1 and 2. clinical examination and pfts in all patients.

Eligibility criteria:
inclusion criteria * subjects suffering from cf, copd, asthma and tobacco exposure (groups 1 to 4) and controls (group 5) * aged more or equal to 18 * stable disease * able to perform pfts * informed consent signed * affiliated to french social insurance exclusion criteria: * acute exacerbation of the disease during the last 2 weeks * iv or oral steroids or antibiotics during the last 2 weeks * hospitalization during the last 2 weeks * colonization by s aureus methicillin resistant and/or burkholderia cepacia

Keywords: bronchopulmonary ignition condensate of exhaled air mucoviscidosis asthma
study of licarbazepine in the treatment of manic episodes of bipolar disorder

Conditions: Bipolar Disorder

Summary: this purpose of this study is to evaluate the safety and efficacy of licarbazepine for the treatment of manic episodes of bipolar disorder.


Eligibility criteria:
inclusion criteria: * diagnosis of bipolar disorder (type i) with manic or mixed episodes (including patients with/without psychotic features or with/without a history of rapid cycling) * in need of psychiatric treatment * cooperation and willingness to complete all aspects of the study exclusion criteria: * current diagnosis other than bipolar i disorder * history of schizophrenia or schizoaffective disorder * drug dependence within 1 month prior to study start or testing positive in a urine drug test * suicide attempt within 1 month prior to study start or at immediate risk of harm to self or others * any form of psychotherapy within 1 month prior to study start

Keywords: bipolar disorder manic episode treatment licarbazepine
buccal misoprostol during cesarean section for preventing postpartum hemorrhage

Conditions: Postpartum Hemorrhage

Summary: objective: to demonstrate that buccal misoprostol administration during cesarean delivery in women with risk factors for uterine atony decreases the need for additional uterotonic medications, uterine atony and postpartum hemorrhage. design: randomized, double-blinded, placebo-controlled trial.

patients and methods: 120 pregnant women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=60) or placebo (n=60) placed in buccal space after umbilical cord clamping. the primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.

Eligibility criteria:
inclusion criteria: * women who underwent delivery either by elective or emergent cesarean section at 24 week gestation or later with preoperative levels of hemoglobin and hematocrit determined up to 72 hours prior to delivery. the patients must have at least one of the risk factors for uterine atony listed below: 1. fetal macrosomia (estimated fetal weight ≥ 4 kilos) diagnosed by clinical measurement (johnson´s technique) or ultrasound measurement (hadlock´s formula). 2. polyhydramnios (defined as phelan´s amniotic fluid index \> 24 cm) 3. twin or multiple pregnancy. 4. prolonged labour (prolonged active phase \> 12 hours) or precipitate labour(cervical dilatation ≥ 10 cm/hour). 5. magnesium sulphate or any other tocolytic agent therapy for ≥ 8 hours before cesarean section. 6. intravenous oxytocin therapy for at least 4 hours before cesarean section. 7. multiparous women (≥ 3 prior abdominal or vaginal deliveries ) 8. clinical chorioamnionitis was defined as maternal temperature of ≥ 38°c in addition to more than one of the following criteria: fetal tachycardia (\> 160 beats per minute), maternal tachycardia (\>100 beats per minute, maternal leukocytosis (15,000 cells/mm3), uterine tenderness or foul smelling amniotic fluid. 9. known myomatosis, uterine müllerian malformations or those diagnosed by ultrasound. exclusion criteria: 1. misoprostol incorrect administration 2. severe allergic, bleeding disorders (e.g., haemophilia); severe asthma or any other absolute contraindication to misoprostol use. 3. any bleeding occurred before delivery (abruptio placentae, placenta praevia) or bleeding due to other causes different than uterine atony.

Keywords: buccal misoprostol uterine atony postpartum hemorrhage
efficacy of prophylactic glycerin suppositories for feeding intolerance in very low birth weight preterm infants: a randomized trial

Conditions: Infant, Very Low Birth Weight

Summary: to evaluate the efficacy of prophylactic glycerin suppositories will accelerate the elimination of meconium from the large intestine and thus reduce the incidence of feeding intolerance in very low birth weight (vlbw) infants


Eligibility criteria:
inclusion criteria: 1. preterm infants with birth weight \< 1250g. 2. inborn or outborn infants 3. less than 72 hours of age. exclusion criteria: 1. congenital malformations. 2. acute abdomen needing surgical intervention. 3. severity of illness such that death is likely in the first few days after birth. 4. inability to get the parental consent.

Keywords: glycerin suppositories feeding intolerance preterm infants prophylactic use elimination of meconium
simultaneous implant placement with vertical and horizontal bone augmentation

Conditions: Alveolar Bone Loss; Dental Implant Failed

Summary: the purpose of this study was to report the clinical and radiographical outcomes of using autogenous cortical bone plates combined with sticky allogenic bone graft for augmenting maxillary anterior atrophic combined horizontal and vertical ridge defects with simultaneous versus staged implant placement.

sufficient alveolar ridge is a prerequisite for successful implant stability, atrophic ridges defects make the placement of regular implants challenging. a variety of materials and surgical techniques are available for bone augmentation procedures prior implant placement. the present study evaluated the effect of sticky allogenic bone graft for the horizontal and vertical ridge augmentation with simultaneous implant placement using autogenous cortical bone plates in maxillary anterior atrophic ridge defects. forty-two patients, with severe maxillary anterior horizontal and vertical atrophic ridge deficiencies were randomly assigned to two groups: staged approach group and simultaneous implant placement group. the two groups were grafted using bone plated buccally and palatally and the defect between plates was grafted by sticky allogenic bone graft. radiographic examination was performed immediately before bone grafting procedure and at 6, 12 months postoperatively, to evaluate the change of bone width and height.

Eligibility criteria:
inclusion criteria: * good general health at the time of surgery * at least 3 months of healing after tooth extraction * horizontally and vertical compromised alveolar ridges exclusion criteria: * thick cortex in the labial/buccal with less cancellous bone inside; * obvious undercut on the labial/buccal side * uncontrolled periodontal conditions or other oral disorders; * history of radiotherapy in the head and neck region