bioihbjkbjnl/mcl2 huggingface dataset:
Bright Light: An Adjunct Treatment for Combat Posttraumatic Stress Disorder (PTSD)
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The investigators are testing novel treatments for combat PTSD: bright light exposure and
      negation ion exposure.
    

Detailed description: 
      Seventy Operation Iraqi Freedom (OIF)/Operation Enduring Freedom (OEF) Veterans with
      posttraumatic stress disorders (PTSD) will be randomly assigned to one of two 4-week
      treatments (45 min/day): (1) bright light exposure or (2) a negative ion generator. Clinical
      assessments ,as well as self-reported measures of PTSD, anxiety, depression, and sleep will
      be assessed
    

Intervention name(s): Bright Light Exposure; Negative Ion Generator
Intervention type(s): Other; Other
Intervention description(s): Administered via bright light box; Administered via Negative Ion Generatore
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: posttraumatic stress disorder; phototherapy; anxiety; depression; sleep; negative ion generator
Correlation of Hyperghrelinemia With Carotid Artery Intima-Media Thickness in Children With Prader-Willi Syndrome
Condition: Prader Willi Syndrome; Obesity
MeSH terms: Prader-Willi Syndrome; Syndrome
Study type: Observational

Summary: 
      Prader-Willi syndrome (PWS) is a genetic disorder characterized by childhood-onset obesity
      and endocrine dysfunction that leads to cardiovascular disability and early death within the
      first 3 decades of life.To assess the significance of risk factors for future disabilities,
      carotid artery intima-media thickness (IMT) was measured and correlated with known
      atherosclerotic risk factors in 27 children with PWS and 24 age-, sex-, and body mass index
      (BMI)-adjusted controls.
    

Detailed description: 
      Main outcome measures: Correlation of IMT with age, standard deviation score of BMI
      (BMI-SDS), high-density lipoprotein cholesterol (HDL), low-density lipoprotein cholesterol
      (LDL), C-reactive protein, HOMA-IR and ghrelin.
    

Observational model: Case-Control
Time perspective: Other
The Efficacy of Focus Extracorporeal Shock Wave Therapy on Hamstring Tightness
Condition: Hamstring Tightness
Study type: Interventional

Summary: 
      To study efficacy of focus extracorporeal shock wave therapy on the flexibility of hamstring
      muscles in healthy subjects
    


Intervention name(s): focus extracorporeal shock wave therapy; Home stretching program
Intervention type(s): Device; Behavioral
Intervention description(s): F-EWST with 0.15 mJ/mm2 intensity and 6 Hz frequency for 3 weeks. The shocking head was placed at the muscle positions of the long head of the bicep femoris, semitendinosus, and semimembranosus for 1,000, 500, and 500 shocks, respectively, accounting for 2,000 shocks in total/ session/week.; The leaflet on hamstring stretching exercises (in a sitting posture)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study Using Transorbital Alternating Current Stimulation for People With Glaucoma
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional

Summary: 
      This pilot study will test the preliminary efficacy and feasibility of an intervention
      protocol for one method of electric current stimulation, repetitive transorbital alternating
      current stimulation (rtACS), to treat visual impairment in people with glaucoma. We will
      evaluate a study protocol to use in future clinical trials to test the effectiveness of rtACS
      to ameliorate the progressive effects of vision loss both structurally and functionally in
      the eye, the visual pathway, and in regard to people's independence (i.e., functional
      ability). In this prospective, randomized controlled, double-masked pilot study, we will: 1)
      determine an effect of rtACS on ophthalmic structure and function (from retina to visual
      brain), 2) assess the methodology of procedures for assessment of people's functional ability
      and quality of life (QoL) to determine an effect of rtACS, and 3) assess the feasibility and
      implementation of the pilot study protocol for a larger multi-site, randomized controlled
      trial.
    

Detailed description: 
      Participants will engage in baseline, intervention, post-intervention, and follow-up visits
      over the span of approximately 8 weeks. The expected outcomes for this project are that (1)
      rtACS activates viable but poorly or non-functional retinal ganglion cells to improve their
      structural and functional capabilities, (2) measures of retinal, optic nerve, and visual
      brain structures and function will correspond with improvement in visual function, and (3)
      changes in visual function following rtACS will be associated with improvements in
      participants' functional ability and QoL. rtACS has successfully been used in the
      rehabilitation of visual impairments in people with optic neuropathies; however, we do not
      know the clinical value of rtACS specifically for people with glaucoma, including the effect
      of rtACS on people's functional ability and QoL.
    

Intervention name(s): rtACS Stimulation; Sham Intervention
Intervention type(s): Device; Device
Intervention description(s): Electric current stimulation; rtACS is a non-invasive application of electric current to stimulate the retina to induce synaptic efficacy, in particular those cells that have some measure of dysfunction but are not dead, and oscillations of nearby neuronal ensembles.; A computer-controlled sham stimulation function for masking interventionist to study group. The device will be used to deliver a weak electric current stimulation protocol to participants via electrodes placed transorbitally, with one reference electrode positioned elsewhere.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Transorbital Alternating Current Stimulation; Glaucoma
Supervision Models in Training Environments
Condition: Supervision; Anesthesia
Study type: Interventional

Summary: 
      Attending physicians often supervise novice junior residents in a direct one-to-one format.
      Alternatively, a senior resident can be paired with a new trainee under the non-direct (but
      immediately available) supervision of an attending physician. Resident supervision has been
      considered an important step towards independent practice. Both models are ubiquitous in the
      United States, but no study to date has been performed if one model is better than the other
      with respect to supervision scores.
    

Detailed description: 
      Supervision of residents is a cornerstone of ACGME accreditation and a critical focus of any
      training program. A nine-faceted, validated survey has been used to assess quality and
      effectiveness of supervision in training environments. Residents that assign poor scores for
      faculty members also tend to poorly evaluate the department-at-large. Further, residents that
      evaluate supervisors unfavorably also tend to report more patient safety mishaps in the
      context of a less safe work environment. Previous literature that used this supervision scale
      concluded that residents who reported mean department-wide supervision scores less than 3
      (frequent) reported significantly more frequent occurrences of mistakes with negative
      consequences to patients and medication errors.

      Attending physicians often supervise novice junior residents in a direct one-to-one format.
      Alternatively, a senior resident can be paired with a new trainee under the non-direct (but
      immediately available) supervision of an attending physician. Resident supervision has been
      considered an important step towards independent practice.. Both models are ubiquitous in the
      United States, but no study to date has been performed if one model is better than the other
      with respect to supervision scores.
    

Intervention name(s): Survey
Intervention type(s): Behavioral
Intervention description(s): A survey will be completed by the participants at the conclusion of each day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Excimer Laser Assisted IVC Filter Retrieval
Condition: IVC Filters
Study type: Observational [Patient Registry]

Summary: 
      This is a prospective chart review to follow our laser-assisted IVC filter retrieval
      patients. We intend to validate existing literature and scientific findings by publishing our
      own clinical experience in difficult IVC filter retrievals.
    

Detailed description: 
      At Northwestern Memorial Hospital in Chicago, IL USA, IVC filters are successfully removed
      >95%. Technical failures, although rare, are usually related to excessive endoluminal
      scarring at the point of IVC filter implantation. Adjunctive (or advanced) removal techniques
      are often employed in difficult cases. The excimer laser sheath has been successfully used at
      Northwestern for patients who had failed all other retrieval techniques.

      Before a patient is to undergo an IVC filter removal using the Excimer Laser Sheath they will
      be consented to participate in the chart review study and become a part of a registry kept at
      Northwestern Memorial Hospital. The procedure itself is not being used as part of the study.
      Chart reviews will be completed and data collected on the procedure to remove the filter.
      Follow up after the procedure by phone call and chart review will be completed at least once,
      1 week after the filter removal.
    

Intervention name(s): Prospective Chart Review
Intervention type(s): Other
Intervention description(s): The laser assisted IVC filter removal procedure itself is not part of this study. This is a prospective chart review for patients undergoing this procedure.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Anyone ages 18-100 years old that will undergo laser assisted IVC filter removal at
        Northwestern Memorial Hospital in Chicago IL USA
      
Keywords: Inferior Vena Cava Filter; IVC Filter; IVC filter removal; Excimer Laser
Computerized Cognitive-Behavioral Therapy for Auditory Hallucinations
Condition: Schizophrenia, Schizoaffective Disorder
MeSH terms: Hallucinations; Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      This is a randomized controlled trial, examining the effects of a computerized,
      internet-based Cognitive Behavioral Therapy (CBT) Intervention for persons with a
      schizophrenia spectrum disorder who experience distressing auditory hallucinations (voices).
      Participants are randomized to one of two conditions: either to receive the 10-session
      computer-based program on a weekly basis, or to their usual care at their mental health
      clinic. This study takes place at Cambridge Health Alliance in Cambridge Massachusetts. It is
      hypothesized that the participants who participate in the CBT program will have significant
      improvements in the severity of their auditory hallucinations, as well as their associated
      distress, compared to the participants receiving usual care.
    


Intervention name(s): Computer CBT
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK 134612
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      Subjects were previously vaccinated at 11 to 17 years of age. This extension phase starts 24
      months after vaccination and the subjects who were vaccinated in the primary study will be
      enrolled in this extension phase. No new subjects will be enrolled.
    

Detailed description: 
      Subjects were previously vaccinated at 11 to 17 months of age with GSK Biologicals'
      meningococcal vaccine 134612 or with Mencevax™. This extension phase starts 24 months after
      vaccination and the subjects who were vaccinated in the primary study will be enrolled in
      this extension phase. No new studies will be enrolled. The subjects will have 4 blood samples
      taken: at 24, 36, 48 and 60 months after vaccination.
    

Intervention name(s): Blood Sampling
Intervention type(s): Procedure
Intervention description(s): A blood sample will be taken yearly at each long-term follow-up visit (i.e. Year 2 through Year 5) after vaccination during the primary study. No vaccines are administered in the long-term follow-up study
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: meningococcal vaccine GSK 134612
Acute Kidney Injury in Non-Critical Care Setting: Elaboration and Validation of an In-hospital Death Prognosis Score
Condition: Intra-hospital Mortality; Epidemiological Study
MeSH terms: Acute Kidney Injury
Study type: Observational [Patient Registry]

Summary: 
      Acute renal failure (AKI) is defined by a deterioration of kidney function over a short
      period. This definition was clarified recently in order to allow homogenization and optimal
      comparison of patients in clinical studies by the classifications RIFLE in 2004, AKIN in 2007
      and KDIGO in 2013. These classifications decline several stages of ARI through the increase
      in the plasma creatinine level and the decrease in urine flow.

      Even though AKI is a frequent pathology in all hospitalized patients, there are only few
      studies that are interested in this entity in conventional hospital services except intensive
      care or intensive care. Indeed, the recent meta-analysis including the 154 studies focusing
      on the ARI defined by the KDIGO criteria, only 7 have recruited patients in conventional
      nephrology services. However, patients admitted for an ARI which requires treatment in a
      medical service probably have epidemiological characteristics and a different prognosis than
      those requiring treatment in intensive care. In addition, the parameters of the RIFLE, AKIN
      or KDIGO scores are more difficult to establish in conventional hospital services than in
      intensive care, especially for hourly monitoring of urine flow, not allowing an optimal
      classification of the episode of IRA.

      This study set out to develop a prognostic score for intra-hospital mortality in ARI based on
      a first historical cohort. The investigators then validated this score on a second
      prospective cohort obtained over an independent inclusion period and at a distance from the
      first.
    


Intervention name(s): Prognostic score
Intervention type(s): Other
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        We included all patients over 18 years of age admitted for ARI, defined by an increase in
        serum creatinine of more than 50% of baseline serum creatinine in patients without chronic
        kidney disease or increased serum creatinine at 100 umol / L compared to baseline serum
        creatinine if the patient had a serum creatinine clearance less than 60 mL / min / 1.73m2
        calculated by the MDRD (Modification of the Diet in Renal Disease) formula, hospitalized in
        the Nephrology department of the Besançon University Hospital Center. Our exclusion
        criteria were kidney transplantation and patients from the intensive care unit.

        In our analysis, we constituted two cohorts: the first from January 1, 2001 to December 31,
        2004 for the development of the prognostic score, then a second extending from January 1
        2010 to December 31, 2013 for the validation of the score.
The Effects of Homogenized and Unhomogenized Milk on Postprandial Metabolism in Healthy Overweight Men
Condition: Hyperlipidemias; Inflammation; Atherosclerosis
MeSH terms: Atherosclerosis; Overweight; Hyperlipidemias; Hyperlipoproteinemias; Inflammation
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effects of homogenized, unhomogenized and skimmed
      milk on postprandial metabolism in healthy overweight men
    


Intervention name(s): Homogenized milk; Unhomogenized milk; Skimmed Milk
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 900 mL homogenized milk 2 slices of bread with marmalade 2 pieces of crisp bread; 900 mL unhomogenized milk 2 slices of bread with marmalade 2 pieces of crisp bread; 900 mL skimmed milk 44 g of salted butter 2 slices of bread 2 pieces of crisp bread
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Milk; Homogenization; Postprandial hyperlipidemia; Postprandial inflammation; Overweight
Emergency Department Rapid Intravenous Rehydration (RIVR) for Pediatric Gastroenteritis
Condition: Gastroenteritis; Dehydration
MeSH terms: Gastroenteritis; Dehydration; Emergencies
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will look at children with dehydration secondary to gastroenteritis requiring IV
      rehydration and determine whether the proportion rehydrated after two hours is greater in the
      children who receive rapid intravenous rehydration (RIVR) or in the children who receive
      standard IV rehydration.
    

Detailed description: 
      Despite a movement toward increased use of enteral rehydration, many children still receive
      prolonged IV rehydration in the emergency department (ED). These children commonly receive a
      single IV bolus of normal saline followed by the administration of a hypotonic solution at a
      maintenance rate.

      The mean time spent in the ED by children receiving IV rehydration is significantly longer
      than the mean time required to treat all other conditions. ED overcrowding has been
      associated with poor outcomes, prolonged pain and suffering, and dissatisfaction. One of the
      solutions proposed in the American Academy of Pediatrics Policy Statement on ED overcrowding
      is that hospitals should strive to improve the efficiency of the care provided. One small
      step in this direction may be to improve our management of gastroenteritis and dehydration.
    

Intervention name(s): Standard IV rehydration; Rapid intravenous rehydration (RIVR)
Intervention type(s): Drug; Drug
Intervention description(s): A 20 mL/kg 0.9% normal saline bolus (maximum 999 mL) will be administered over 1 hour. This will be followed by D5-0.9% normal saline at a maintenance rate (maximum 55 mL/hr).; A 60 mL/kg 0.9% normal saline bolus (maximum 999 mL) over 1 hour will be administered. This will be followed by D5-0.9% normal saline at a maintenance rate (maximum 55 mL/hr).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pediatrics; Gastroenteritis; Dehydration; IV Rehydration
To Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P59 in Healthy Subjects
Condition: SARS-CoV-2 Infection
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I study that randomized, double-blind, Placebo-controlled, Parallel Group,
      Single Ascending Dose Study to evaluate Safety, Tolerability and Pharmacokinetics of CT-P59
      in Healthy Subjects.
    

Detailed description: 
      CT-P59 is a monoclonal antibody targeted against SARS-CoV-2 spike RBD as a treatment for SARS
      CoV 2 infection. CT-P59 is currently being developed by the Sponsor as a potential treatment
      for SARS-CoV-2 infection. In this study, safety, tolerability, and pharmacokinetics of CT-P59
      will be evaluated in healthy subjects.
    

Intervention name(s): CT-P59; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): CT-P59 will be administered; Placebo-matching CT-P59
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Screening
Assessment of Safety, Pharmacokinetics and the Effect of BIBR 1048 MS on Coagulation Parameters in Healthy Volunteer Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess safety, pharmacokinetics and the effect of BIBR 1048 MS on coagulation parameters
      in healthy volunteer subjects.
    


Intervention name(s): BIBR 1048 MS - low dose; BIBR 1048 MS - high dose; BIBR 1048 MS + Pantoprazole
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Pantoprazole; Dabigatran
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Subcutaneous Elafin in Healthy Subjects
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      A multiple-ascending-dose (MAD), randomized, placebo-controlled, blinded trial to evaluate
      the safety, tolerability, pharmacokinetics, and pharmacodynamics of Elafin in healthy adult
      subjects. The purpose of this study is to assess Elafin that is being developed for treatment
      of PAH. Elafin inhibits elastase, an enzyme that is increased in pulmonary hypertension and
      is a major factor in the development of PAH. Elafin will be administered subcutaneously daily
      for 7 days in normal healthy subjects followed over a 28 day time period.
    

Detailed description: 
      There will be a total of up to 30 subjects randomly assigned to 5 groups with 6 subjects in
      each group. One subject in each group will be assigned to placebo drug and 5 subjects to
      active drug. Subjects in each group will receive a single daily dose of Elafin/Placebo for
      total of 7 days. There will be ascending doses across groups. Groups receiving a higher dose
      will only do so after the previous group has completed dosing (i.e., 7 days). Each subject
      will be followed over a 28 day time period.

      An interim trial analysis will occur after completion of the 2nd cohort in order for the
      research team to review PK and safety data to determine modification (if needed) of dosing
      strategy for groups 3-5. The study is also designed to absorb a de-escalation strategy. If
      the protocol requires a lowering of dose from the initial dosing, a new group will be
      assigned a low-dose subcutaneous Elafin regimen.

      The study will conclude at any dose that produces clinically significant adverse effects and
      identified as Maximum Tolerated Dose (MTD).
    

Intervention name(s): Elafin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Elafin subcutaneous.; Placebo subcutaneous.
Other intervention name(s): Tiprelestat
Intervention MeSH terms: Elafin
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment