bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Cyclic Prolonged Parenteral Nutrition in Neonates
Condition: Cholestasis in Newborn
MeSH terms: Cholestasis
Study type: Interventional

Summary: 
      The aim of our study is to compare the incidence of PNAC in newborns receiving cyclic versus
      continuous parenteral nutrition (PN) in those newborns who need prolonged PN. The secondary
      aims are to compare incidence of sepsis and catheter related sepsis, mean length of hospital
      stay, mortality, nutritional status at two years of chronological age and predisposing
      factors to the development of parenteral nutrition associated cholestasis (PNAC) between the
      two groups, and to evaluate the adverse effects of the method of cycling used.

      This was a single-center, prospective randomized not blinded study was conducted in a level 3
      neonatal intensive care unit from July 2010 to January 2015. Infants with hemodynamic
      instability until a stable situation, congenital hepatic disease, preterm infants with
      diagnosis of respiratory distress syndrome or persistent ductus arteriosus and lack of
      authorization from the parents or guardians were excluded.
    


Intervention name(s): Cyclic parenteral nutrition
Intervention type(s): Procedure
Intervention description(s): Cyclic parenteral nutrition was provided according to a method described by Longhurst et al. Patients were initially cycled of PN for 1 hour per day with increased rate of 1 hour with a maximum time out of PN of 4 hours for preterm babies < 37 weeks GA and 6 hours for term newborns. Glucose was monitored at half the time without PN to detect the hypoglycemia.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intrahepatic cholestasis; infant newborn; cyclic parenteral nutrition
Lifestyle Changes Through Exercise and Nutrition
Condition: Obesity; Diabetes
Study type: Interventional

Summary: 
      The goal of The LEAN project intervention is to promote weight loss, healthy dietary habits,
      increased physical activity, improved blood glucose and cholesterol, and weight related
      quality of life in obese African American adults through a sustainable, technology enhanced,
      church-based program.
    

Detailed description: 
      The LEAN Project is a community-based weight loss program that is delivered through churches
      serving lower-income, obese, African American adults. The intervention will involve training
      community health coaches to deliver the intervention. These community health coaches will be
      individuals who are members of the church and who are willing to be trained on how to deliver
      behaviorally-based, empirically proven, lifestyle change interventions. These community
      health coaches will be trained by the staff at Pennington Biomedical, who have experience
      training and delivering these types of interventions. The community health coaches will
      deliver the intervention through their respective church after being trained. Weekly text
      messages will be sent to participants in order to supplement the intervention sessions and
      provide support. The primary aim is to determine if the trained community health coach
      church-based intervention will result in significant weight loss. Secondary aims will assess
      blood glucose, cholesterol, physical activity, food intake, and weight related quality of
      life.
    

Intervention name(s): Weight loss intervention
Intervention type(s): Behavioral
Intervention description(s): The intervention will involve utilizing trained community health coaches to deliver the weight loss intervention. There will be 10 group based sessions conducted at each church over 6 months. Session frequency will be 4 weekly sessions (4) for the first month, bimonthly sessions for 2 months (4) and monthly sessions for 2 months (2). The study is based upon weight loss strategies that have been utilized in the Diabetes Prevention Program. The group sessions will be augmented by utilizing text messages. The text messages will be delivered weekly and three types of messages will be delivered: 1) lesson content, 2) motivational, 3) behavioral prompts.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Weight Loss; African American; Community Based; Mobile technology; Translational science
Evaluating the Plasma, Epithelial Lining, and Alveolar Macrophage Concentrations of Intravenous Carbavance™ (RPX2014/RPX7009) in Healthy Adult Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      RPX7009(beta-lactamase inhibitor) is being studied in combination with a carbapenem (RPX2014)
      to treat bacterial infections, including those due to multi-drug resistant bacteria.
    

Detailed description: 
      The worldwide spread of resistance to antibiotics among Gram-negative bacteria, particularly
      members of the ESKAPE group of pathogens, has resulted in a crisis in the treatment of
      hospital acquired infections. In particular, the recent dissemination of a serine
      carbapenemase (e.g., KPC) in Enterobacteriaceae in US hospitals now poses a considerable
      threat to the carbapenems and other members of the beta-lactam class of antimicrobial agents.

      Rempex is developing a fixed combination antibiotic of a carbapenem (RPX2014) plus a new
      beta-lactamase inhibitor (RPX7009) which has activity against serine beta-lactamases,
      including KPC. This Phase 1 study will assess the pharmacokinetics of intravenous RPX2014 and
      RPX7009 in plasma and epithelial fluid.
    

Intervention name(s): RPX7009 and RPX2014
Intervention type(s): Drug
Intervention description(s): The study is designed to enroll approximately 25 healthy subjects. The study will evaluate the plasma, epithelial lining fluid, and alveolar macrophage concentrations of Carbavance (RPX7009/RPX2014)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Zidovudine 300 mg Tablets, USP Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The objective of this study was to assess the single-dose relative bioavailability of Ranbaxy
      and GlaxoSmithKline (Retrovir ®) 300 mg Zidovudine tablets, under fed conditions
    

Detailed description: 
      This was an open label, randomized, single dose, 2-way crossover, comparative bioavailability
      study performed on 68 healthy adult volunteers. In each period, subjects were housed from at
      least 10 hours before dosing until after the 12 hour blood draw. Single oral dose 300 mg
      Zidovudine doses were separated by a washout period of 7 days.

      A total of sixty-eight (68) healthy adult subjects (29 males and 39 females) were enrolled in
      the study, of which sixty five (65) subjects (29 males and 36 females) completed the clinical
      portion of the study.
    

Intervention name(s): Zidovudine 300mg tablets
Intervention type(s): Drug
Intervention MeSH terms: Zidovudine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence
Investigation Of Absorption And Pharmacokinetics Of A Single Dose Of Controlled Release Pregabalin Tablet Administered Fasted In The Evening or Immediately Following A 600-750 Calorie Evening Meal As Compared To Single Dose Of Immediate Release Pregabalin Capsule In Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics of a single dose of a
      pregabalin controlled release (CR) tablet administered fasted in the evening relative to a
      single dose of the CR tablet administered immediately following a 600 to 750 calorie evening
      meal. The single dose pharmacokinetics of the pregabalin CR administered fed or fasted will
      also be compared to the single dose pharmacokinetics of the pregabalin immediate release (IR)
      capsule. In addition, the safety and tolerability of these 3 treatments will be evaluated.
    

Detailed description: 
      Evaluate the absorption, pharmacokinetics, safety/tolerability of a single dose of a
      pregabalin CR tablet under various conditions as compared to single dose of pregabalin IR
      capsule
    

Intervention name(s): Pregabalin controlled release, 330 mg, 600- 750 calorie; Pregabalin controlled release, 330 mg, fasted; Pregabalin immediate release, 300 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single oral dose of 330 mg controlled release tablet administered following a 600 to 750 calorie evening meal; A single oral dose of 330 mg controlled release tablet administered fasted in the evening; A single oral dose of 300 mg immediate release capsule administered in the evening
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: pregabalin; pharmacokinetics; bioavailability; bioequivalence
Association Between CytochromeP4501A2 and CytochromeP4502E1 Gene Polymorphisms and Metabolism of Theophylline
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The aim of this study is to determine whether common CYP1A2 and CYP2E1 gene polymorphisms
      effect metabolism of theophylline in chronic obstructive pulmonary disease patients.
    


Intervention name(s): theophylline
Intervention type(s): Drug
Intervention description(s): After oral theophylline 200mg per day for two weeks,bood sample will be collected for determining plasma concentrations of theophylline and it's metabolites and the genotypes of CYP1A2 and CYP2E1
Intervention MeSH terms: Theophylline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: COPD; theophylline; CYP1A2; CYP2E1
Association Analysis for Chronic Diseases Based on Resident Health Records by Using Big Data Methods
Condition: Chronic Disease
MeSH terms: Chronic Disease
Study type: Observational

Summary: 
      This is an observational study to analysis the association factors for common diseases,
      including chronic obstructive pulmonary disease, coronary artery disease, hypertension,
      diabetes etc, based on resident healthcare records. More than 10 million resident healthcare
      records should be collected for the associations study by using big data methods.
    


Intervention name(s): not any intervention
Intervention type(s): Other
Intervention description(s): not any intervention
Observational model: Ecologic or Community
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The investigators collect data regarding residents health records from rural and urban in
        China. This study needs more than 10 million resident records from 2010.
Activating Treatment as Prevention Through Community Mobilization in South Africa
Condition: HIV
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the impact of a community mobilization intervention
      on the uptake of HIV testing, linkage to and retention in HIV care using a community, cluster
      randomized trial.
    

Detailed description: 
      Eight of 16 intervention naïve communities in the Agincourt HDSS will be randomized to
      receive the CM intervention to activate TasP based on the investigators CM conceptual
      framework. The 16 villages will be randomized based on the "restricted randomization"
      approach, a stratification method to ensure overall balance between intervention and control
      communities.

      Intervention activities will map onto the investigators six mobilization domains identified
      in the investigators preliminary work as key components for communities to mobilize for
      change around HIV prevention. These activities will support communities to: 1) identify a
      shared concern around testing, linkage and retention in care; 2) enable communities to
      develop critical consciousness around TasP; 3) facilitate identification and development of
      structures and networks to disseminate information and activities around TasP; 4) identify
      and engage community leadership around TasP; 5) take collection action to support TasP; and
      6) build community cohesion to address the HIV epidemic and support access to care.

      The investigators will evaluate the impact of the intervention using a linked data set
      including electronic clinic records and the HDSS census data, which will allow us to
      determine whether people in the intervention communities test at higher proportions than
      those in control communities, whether individuals who test positive in the intervention
      communities are more likely to receive CD4 testing and initiate treatment within 3 months
      than the control communities, and whether those who are eligible and not eligible for
      treatment are retained in care.

      The investigators will implement a representative cross-sectional survey in all 16 villages
      prior to and following the intervention in order to examine changes in CM domains across
      villages and the mechanisms through which the intervention affects HIV testing, linkage and
      retention.

      In addition, intervention progress and dosage will be carefully monitored through a tracking
      system to document all workshops and activities that are carried out in each village.
    

Intervention name(s): Community Mobilization Program
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Prognostic Value of Neonatal Markers for the Development of Neurosensorial Sequelae in Children Infected by Cytomegalovirus in Utero
Condition: Congenital Cytomegalovirus Infection
MeSH terms: Cytomegalovirus Infections
Study type: Interventional

Summary: 
      The main objective of this study is to validate , in the neonatal period, a prognostic score
      for the development of neurosensorineural sequelae at 1 year and at 2 years in neonates
      infected in utero by cytomegalovirus. This score will be based on clinical, imaging and
      biological criteria .

      The second objective of the study is to estimate the prevalence of this infection in France
      and to describe its epidemiology through the screening of 12,000 consecutive neonates.
    

Detailed description: 
      Infection with cytomegalovirus (CMV) is the most frequent cause of congenital neurological
      handicap of infectious origin in industrialized countries. Around 10% of infected neonates
      have symptoms and more than 50% of those will develop long term neurological sequelae and
      sensorineural hearing loss. Among asymptomatic infected neonates 10 to 15% will ultimately
      develop hearing loss. To establish the prognosis of infected neonates remains difficult and
      the purpose of the study is to better define early prognosis factors The true burden of CMV
      congenital infection is unknown in France: the prevalence of the infection as well as the
      description of its epidemiology (proportion of symptomatic and asymptomatic cases, rate of
      long term sequelae, proportion of cases following primary or secondary maternal infections)
      are unknown.
    

Intervention name(s): detection of CMV
Intervention type(s): Other
Intervention description(s): Clinical, radiological and laboratory (virological and immunological) standardized reports
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Cytomegalovirus, congenital, handicap
Mineralocorticoid Receptor, NMDA Receptor and Cognitive Function in Depression
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The steroid hormone cortisol is released in response to stress and acts in the central
      nervous system upon glucocorticoid (GR) and mineralocorticoid receptors (MR). GR are widely
      distributed across the brain while MR are predominantly expressed in the hippocampus and
      prefrontal cortex - two brain areas closely related to memory and executive function.
      Stimulation of MR leads to an increase of glutamate that act on glutamatergic NMDA receptors
      in the hippocampus and prefrontal cortex. In previous studies, the investigators have shown
      that fludrocortisone, a mineralocorticoid receptor (MR) agonist, improves memory and
      executive function in depressed patients and healthy controls. However, depressed patients
      not only exhibit cognitive deficits in traditional neuropsychological domains such as memory
      or executive function. In addition, there are depression-specific alterations such as
      cognitive bias and deficits in social cognition, two clinically highly relevant areas.
      Therefore, the specific aims of this renewal proposal are two-fold:

        -  To examine whether beneficial effects of fludrocortisone in depressed patients can be
           extended to depression-specific cognitive bias and to social cognition

        -  To determine whether beneficial effects of fludrocortisone depend on NMDA-receptor
           function and whether these beneficial effects can be enhanced by NMDA receptor
           stimulation.

      The investigators hypothesize that fludrocortisone will improve cognitive bias and social
      cognition in depressed patients and that its beneficial effects depend on the NMDA receptor.
      Therefore, the investigators further hypothesize that the effects of fludrocortisone can be
      enhanced by co-administration of the partial NMDA receptor agonist D-cycloserine.

      The study not only advances current knowledge by further examining the mechanism of action by
      which MR stimulation exerts beneficial effects on cognition but extends these effects to
      depression-specific cognitive bias and alterations in social cognition. Furthermore, a
      potential interaction between MR and NMDA receptors is highly clinically relevant given the
      promising results with NMDA receptor antagonists in the treatment of major depression.
    


Intervention name(s): Placebo; Fludrocortisone; D-Cycloserine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo; Fludrocortisone; D-Cycloserine
Intervention MeSH terms: Cycloserine; Fludrocortisone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized double-blind placebo-controlled parallel group design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Efficacy of Hyaluronic Acid Gel and Photobiomodulation on Wound Healing After Surgical Gingivectomy
Condition: Gingival Enlargement
MeSH terms: Gingival Hyperplasia; Gingival Hypertrophy; Gingival Overgrowth
Study type: Interventional

Summary: 
      The aim of this study was to evaluate the effect of hyaluronic acid gel after
      photobiomodulation on the healing of surgical gingivectomy sites
    


Intervention name(s): Photobiomodulation; Hyaluronic acid after photobiomodulation
Intervention type(s): Device; Other
Intervention description(s): The surgical sites were irradiated with a diode laser (980 nm, 0.2W) only.; The surgical sites after gingivectomy were irradiated with a diode laser (980 nm, 0.2W) then covered by 2% Hyaluronic acid gel loaded in a special appliance for each patient.
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Surgical gingivectomy; Hyaluronic acid; Photobiomodulation
Perineural Dexmedetomidine in Adductor Canal Block
Condition: Arthroscopic Medial Meniscectomy
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to explore the effects of peri-neural dexmedetomidine on the duration
      and motor sparing potentials of adductor canal block in adult patients undergoing
      arthroscopic medical meniscectomy in the setting of multimodal analgesia. The investigators
      ultimate goal is to increase the postoperative analgesic time and to preserve quadriceps
      muscle strength to promote safe and early ambulation.
    

Detailed description: 
      Peripheral nerve blocks using long-acting local anesthetics are commonly utilized as the sole
      anesthetic technique or as an adjuvant to general anesthesia for post-operative pain
      management. However, the duration of sensory block after single dose of long acting local
      anesthetics is not consistently sufficient to avoid the use of postoperative opioids. Many
      adjuvants were added to local anesthetics to augment the potency and prolong the duration of
      peripheral nerve blocks. Alpha-2 adrenoceptor agonists such as clonidine have been shown to
      increase the duration of peripheral nerve block. Dexmedetomidine is a more potent and
      selective α-2-adrenoceptor compared to clonidine. Peri-neural dexmedetomidine was evaluated
      in animal studies where it prolonged the duration of sensory and motor blocks of local
      anesthetics without any evidence of neurotoxicity for up to 14 days after initial
      administration. The effectiveness of perineural dexmedetomidine in augmenting the duration of
      sensory block of upper limb extremity blocks is based on good quality clinical evidence.

      Arthroscopic knee surgery is associated with severe postoperative pain which could be
      adequately managed by femoral nerve block. However femoral nerve block has been associated
      with significant motor block and decreased quadriceps muscle strength which may delay
      ambulation and increase the risk of falling. More recently, adductor canal block (ACB)
      emerged as a selective motor sparing effective variant of femoral nerve block. Compared with
      baseline values, the adductor canal block reduces quadriceps muscle strength by 8%, versus
      49% for the femoral nerve block. A recent dose finding MRI study reported that 20 ml of local
      anesthetic is the closest volume to the ED95 for adductor canal block with minimal proximal
      spread and an estimated success probability of 95.1% (95% credibility interval: 91-98%).
    

Intervention name(s): Dexmedetomidine; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): to investigate the effect of dexmedetomidine on motor and sensory properties of adductor canal block; to give normal saline to the other group as a placebo
Other intervention name(s): Precedex; Saline
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment