bioihbjkbjnl/mcl2 huggingface dataset:
The Value of PSP in Predicting Outcome in ICU Surgical Peritonitis Patients
Condition: Peritonitis; Sepsis; Multiple Organ Failure; Death
MeSH terms: Peritonitis; Multiple Organ Failure
Study type: Observational

Summary: 
      The purpose of this study is to determine the diagnostic accuracy of Pancreatic Stone Protein
      (PSP) in predicting patient outcomes with suspected peritonitis in the Intensive Care Unit
      after abdominal surgery and compare PPS with other blood parameters, including C-Reactive
      Protein (CRP), White Cell Count (WCC), Interleucin-6 (IL-6) and Procalcitonin (PCT).
    

Detailed description: 
      Peritonitis is a severe complication after abdominal surgery. Patients admitted at the
      Intensive Care Unit (ICU) following surgery bear the risk of localized infection, sepsis or
      septic shock. Prevention or early detection of such events is important to intervene with an
      appropriate therapeutic action and avoid risking a potentially life-threatening situation.
      White blood cell counts (WCC) and C-Reactive Protein (CRP), Interleucin-6 (IL-6) and
      Procalcitonin (PCT) have all been promising parameters, however, they are useful only in
      selective cases and have a limited diagnostic accuracy.
    

Intervention name(s): All abdominal surgical procedures; Intubation; Imaging
Intervention type(s): Procedure; Procedure; Radiation
Intervention description(s): Laparotomy, Laparoscopy; Ventilatory support; Abdominal ultrasound Computer Tomography Magnetic Resonance Imaging
Other intervention name(s): surgical procedures; Endotracheal Intubation, tracheostomy; Any type of diagnostic or interventional imaging technique
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care clinics
      
Biospecimen description: 
      Whole blood, serum, plasma
    
Keywords: Peritonitis; Sepsis; General Surgery; Intensive Care Units; Sensitivity and Specificity
A Study to Assess the Safety and Tolerability of BMS-986322 in Healthy Participants of Japanese Descent
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of multiple ascending oral
      doses of BMS-986322 in healthy participants of Japanese descent.
    


Intervention name(s): BMS-986322; Placebo for BMS-986322
Intervention type(s): Drug; Other
Intervention description(s): Specified dose on specified days; Specified dose on specified days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: BMS-986322; Japanese descent
Study of Oral PG-116800 Following a Heart Attack
Condition: Myocardial Infarction; Heart Failure; Heart Enlargement
MeSH terms: Myocardial Infarction; Cardiomegaly; Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of the study is to test whether a possible new drug (called PG-116800) can
      prevent some of the damage to heart muscle in patients who have had a heart attack. The study
      will also supply information regarding possible uses of this compound in cardiovascular
      disease.
    

Detailed description: 
      Heart attacks cause damage to heart muscle that can weaken the heart and lead to changes in
      the shape and pumping ability of the heart. These changes can lead to heart failure. An
      enzyme called metalloproteinase (MMP) plays a role in this damage.

      The main purpose of the study is to test whether a possible new drug (called PG-116800) that
      interferes with the MMP enzyme can prevent some of the damage to heart muscle in patients who
      have had a heart attack. The study will also supply information regarding possible uses of
      this compound in cardiovascular disease.

      This is a Phase II "proof-of-concept" study; that is, it is a first attempt to treat sick
      people with the drug to see if it works.

      The study is interventional since we will be using a drug to interfere with the heart tissue
      damage that follows a heart attack.
    

Intervention name(s): PG-116800 (given as PG-530742); Placebo tablet
Intervention type(s): Drug; Drug
Intervention description(s): 200 mg tablet of PG-116800 (given as PG-530742)twice a day for 90 days; placebo tablet, twice a day for 90 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Multilevel Approach to Increasing HPV Vaccine Initiation Among Adolescents - Part 3
Condition: Human Papilloma Virus
MeSH terms: Papilloma
Study type: Interventional

Summary: 
      Our project will assess the feasibility and estimate preliminary efficacy of a multilevel
      intervention to improve HPV vaccine series initiation among adolescents in Medicaid and CHIP.
      The investigators will use two intervention components: postcards and an iPad survey system.
      To estimate efficacy the investigators will select potential participants from Florida
      Medicaid and CHIP. The investigators will assess their claims for the HPV vaccine before and
      after the intervention.
    


Intervention name(s): postcard campaign; Health Information Technology system
Intervention type(s): Other; Other
Intervention description(s): Post card sent to parent only; Accessed by adolescent and provider only
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: preventative; postcard; vaccinate
Mother Milk as a Eye Drop & Premature Retinopathy
Condition: Retinopathy of Prematurity
MeSH terms: Retinal Diseases; Retinopathy of Prematurity; Premature Birth
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effect of using breast milk as eye drops on ROP
      (Retinopathy of prematurity) disease observed in less then 32 weeks gestational age preterm
      babies.
    

Detailed description: 
      Study Design: Prospective randomized placebo controlled trial Setting/Participants: Premature
      babies who are at high risk for retinopathy of prematurity (ROP) during their stay in the
      neonatal intensive care unit (NICU). The study will be carried out at Baskent University and
      it is planned that 70 participants will be included in the study.

      Study Interventions and Measures: After the randomization of the patients, 0.5 ml breast milk
      of the babies' own mothers will drop on the eye to the intervention group twice a day. IN the
      control group, %0.9 normal saline will drop as same amount. Primary outcome is any stage of
      ROP, secondary outcome is severe ROP (laser requiring ROP).
    

Intervention name(s): Normal Saline; Breast milk
Intervention type(s): Drug; Biological
Intervention description(s): 0.5 ml 0.9% normal saline will drop on both eyes twice in a day.; 0.5 ml breast milk from all infant's own mother will drop both eyes twice in a day
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Porspective Randomized Placebo Controlled Trail
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Breast milk; Retinopathy of Prematurity
Safety Study of Herpes Simplex Vaccine in HSV Seronegative and Seropositive Females Between 10 and 17 Years Old
Condition: Herpes Simplex
MeSH terms: Herpes Simplex
Study type: Interventional
Phase: Phase 3

Summary: 
      Main goal of this study is to compare the occurrence of serious adverse events (SAEs) between
      the herpes simplex (gD2-AS04) vaccine group and the Saline control group throughout the study
      period (up to month 12).

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Detailed description: 
      Three groups of females (3000, 1500 and 1500 subjects, respectively) were injected 3 times
      (at months 0, 1 and 6) with the herpes simplex vaccine, the HavrixTM vaccine (control) and a
      Saline solution (placebo), respectively. Subjects were followed over 18 months.
    

Intervention name(s): GSK208141; Havrix (investigational formulation); Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 3 intramuscular doses; 3 intramuscular doses; 3 intramuscular doses
Other intervention name(s): Herpes simplex vaccine; gD2-AS04 vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Herpes Simplex vaccine; Safety; Adolescents; Immunogenicity
Renal and Systemic Vascular Resistance in Chronic Kidney Disease (CKD)
Condition: Chronic Kidney Insufficiency; Hypertension; Vasodilation
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients with reduced kidney function have a higher risk of heart disease and death. Studies
      have shown that blood vessels in patients with hypertension change with a decrease of lumen
      size and growth of the vessel wall. By treating patients with antihypertensive certain
      medication vessel lumen and walls normalize. Treating hypertension in patients with chronic
      kidney disease slows the progression of kidney function loss.

      The aim is to compare different degrees of antihypertensive medication in patients with
      chronic kidney disease and hypertension will slow the progression of kidney loss.
    


Intervention name(s): Beta-blocker, ACE-inhibitor; Calcium Channel Blockers, ACE-Inhibitor
Intervention type(s): Drug; Drug
Intervention description(s): Beta-blocker: 50- 100 mg 1-2 times a day. ACEi: 5-10 mg once a day; Calcium Channel Blockers: 5-10 mg a day. ACEi: 5-10 mg a day
Intervention MeSH terms: Calcium Channel Blockers; Calcium; Adrenergic beta-Antagonists; Angiotensin-Converting Enzyme Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Tolerability Study of Oral EUR-1100 to Treat Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Eosinophilic esophagitis (EoE) is an inflammatory disease of the esophagus, characterized by
      eosinophilic infiltration and gastrointestinal (GI) symptoms. There are no pharmacological
      treatments for EoE approved by the US Food and Drug Administration (FDA). Supported by
      published case series and controlled trials in children and adults, the most widely used drug
      treatment for EoE is off-label use of corticosteroids intended for local (esophageal mucosal)
      action.

      This study will evaluate the safety and tolerability of orally administered EUR-1100 once or
      twice daily. Eligible subjects will be randomized into one of the 3 treatment groups. The
      Treatment Period will be 8 weeks during which subjects will visit the clinic at the screening
      visit, randomization, week 4, 8 and 1 week after end of treatment for clinical symptom
      assessment and safety evaluation. Additional phone visits will occur at week 2 and week 6.
    


Intervention name(s): EUR-1100; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active oral medication; matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Assess Safety, Tolerability, and Pharmacokinetics of Oral Doses for AC430 in Healthy Subjects
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      AC430 will be administered, orally under fasting conditions (fasting 4 hours before and 2
      hours after dosing) with approximately 240 mL of water either once daily or twice daily. It
      is designed to assess the safety, tolerability, and pharmacokinetics of single and multiple
      oral doses of AC430.
    

Detailed description: 
      A dose-finding study of AC430 in healthy volunteers.
    

Intervention name(s): AC430
Intervention type(s): Drug
Intervention description(s): Healthy volunteers will either receive AC430 or placebo.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study Evaluating Nexagon™ in the Treatment of Skin Wounds.
Condition: Wound Healing
MeSH terms: Wounds and Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      Nexagon™ is a novel compound that promotes wound healing by temporarily disrupting cellular
      communication at the wound site, thereby promoting accelerated healing, reducing inflammation
      and pain. This randomized double-blind study will assess the safety, tolerability and
      clinical effect of Nexagon™ when applied to skin wounds created by punch biopsy in healthy
      volunteers. 43 healthy, fair-skinned males and females between ages 18-40 will be enrolled.
      Subjects will be reviewed again at 3 months and 9 months for follow-up safety assessments and
      wound appearance evaluation.
    


Intervention name(s): Nexagon™ or Nexagon™ vehicle
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Wound; Healing
A Study of LY03005 vs Pristiq
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate relative bioavailability between 80 mg LY03005
      oral tablets and 50 mg Pristiq® oral tablets after a single dose of each drug in a cross-over
      2-period design under fasting condition in healthy subjects between 18 and 50 years of age.
    

Detailed description: 
      Fifty six (56) eligible subjects will be enrolled and assigned to either Group A or Group B
      at a 1:1 ratio.
    

Intervention name(s): LY03005; Pristiq
Intervention type(s): Drug; Drug
Intervention description(s): Drug: LY03005 80 mg, oral tablets, single dose; Drug: Pristiq 50 mg, oral tablets, single dose
Other intervention name(s): Desvenlafaxine
Intervention MeSH terms: Desvenlafaxine Succinate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depressive Disorder, Major; Depressive Disorder; Mood Disorders; Mental Disorders; Desvenlafaxine Succinate; Serotonin and Noradrenaline Reuptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Physiological Effects of Drugs; Antidepressive Agents; Psychotropic Drugs
Relative Bioavailability Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a BA study comparing the bioavailability of two new capsule formulations and one
      solution formulation to the isethionate capsule used in phase 1 and 2 trials in healthy
      volunteers.
    


Intervention name(s): PD-0332991; PD-0332991; PD-0332991; PD-0332991
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): isethionate hard capsule, 125 mg, single dose; freebase hard capsule with a "small" particle size, 125 mg, single dose; freebase hard capsule with a "large" particle size, 125 mg, single dose; oral solution, 50 mg, single dose
Intervention MeSH terms: Palbociclib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: BA/BE; PK; PD-0332991; PF-05089326; Breast Cancer
Mental Health Services for Foster and Adopted Children
Condition: Problem Behaviors; Attention Deficit Hyperactivity Disorder; Depression
MeSH terms: Attention Deficit Disorder with Hyperactivity; Problem Behavior
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will determine the effectiveness of a relationship-based intervention in improving
      the interaction between caregivers and young children placed in their care.
    

Detailed description: 
      Infants and toddlers who are placed into foster or adoptive care often exhibit a number of
      behavioral, emotional, and physiological problems. In the absence of specialized services,
      problems in the relationship between caregiver and child may develop; problems in the child's
      functioning often persist and are exacerbated. This study will attempt to alleviate the
      attachment and regulatory difficulties that affect many young children placed into care.

      Children are randomly assigned to either an experimental group or to a treatment control
      group for 3 years. The experimental group focuses on relational issues; the control group
      focuses on cognitive development. Caregivers receiving the relational intervention are
      trained to provide nurturing care, and to help children learn to develop adequate regulatory
      skills. Caregivers in the treatment control group receive training designed to enhance
      children's cognitive development. Caregivers in both groups will receive 10 home visits.
      Observations of children and parents are used to assess participants.
    

Intervention name(s): Attachment and Biobehavioral Catch-up; Developmental Education for Families
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Attachment and Biobehavioral Catch-up is a 10 session in-home intervention that targets synchrony, nurturance, and calming parental behavior.; Developmental Education for Families is a 10-session in home intervention that targets children's cognitive development.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Attachment; Intervention; Prevention
The Effectiveness of Low Carbohydrate Diet in Reducing Polypharmacy for Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study determines whether an educational intervention with a 90 g/day LCD is safe,
      effective and has good compliance for poorly controlled type 2 diabetes patients.
    

Detailed description: 
      Poorly controlled type 2 diabetic men and women, aged between 20 and 80 years, with HbA1c≧
      7.5% (58mmol/mol) in the previous 3 months participated in this randomized controlled
      18-month trial at a medical center. Patients were randomly assigned to the interventional
      group and given a 90g/day low carbohydrate diet (LCD) or the controlled group, which
      maintained a standard calorie-restricted diet (CRD). All patients received periodic
      educational intervention and were monitored for weight, body composition, waist girth, hip
      girth, thigh girth, pre- and post-prandial serum glucose, HbA1c, lipid profile(Cholesterol,
      Triglyceride. HDL, LDL, sdLDL), renal function, microalbumin/cre, carotid intima-media
      thickness (IMT),and medication effect score (MES).
    

Intervention name(s): Low carbohydrate diet; Calori restricted diet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): For the LCD group, the daily carbohydrate intake was limited to less than 90g, without any restriction to total energy. The concept of a LCD was introduced and an educational 15 g equivalent carbohydrate food list was provided. The easy conversion method is that 15 g equivalent carbohydrate =1/4 bowel of rice= 1/2 bowel of noodle = 1 slice of toast = 3 soup-spoon of oats = one bowl of fruit =1/2 regular size banana= one glass of milk = 3 dumplings. Less than two equivalent 15g-carbohydrate intakes per meal were advised.; For the calori restricted diet group, the target total calorie intake was calculated by multiplying the ideal body weight by 25 kcal/kg for those with a BMI in the range 18.5 to 24, 20 kcal/kg for obese subjects with a BMI > 24 and 30 kcal/day for underweight subjects with a BMI <18.5. The macronutrient percentage was 50-60% for carbohydrate, 1.0-1.2 g/kg for protein and fat ≦30%.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: None (Open Label)
Primary purpose: Other
Keywords: Type 2 Diabetes Mellitus; Low carbohydrate diet
5-element Music Therapy on Patients With Breast Cancer
Condition: Breast Cancer Female; Quality of Life; Depression, Anxiety
MeSH terms: Breast Neoplasms; Depression
Study type: Interventional

Summary: 
      In this study, we observed the clinical effect of using music therapy of TCM to improve the
      status of liver depression in patients with postoperative breast cancer patients, Second we
      want to explore the efficacy and advantages of traditional Chinese medicine in patients with
      postoperative breast cancer, and to reveal the clinical use of the efficacy and superiority.
    

Detailed description: 
      The study is a prospective controlled trial. Sixty-four patients were divided randomly into
      two groups. Patients were randomly divided into the treatment group and the control group,
      namely, the music treatment group and the health education group. The treatment group was
      given at least 30 minutes of individual music therapy and group music therapy every 3 weeks.
      Instead, the control group was given every 3 weeks of health education preach. It will take
      12 weeks for treatment and observation. The efficacy was evaluated by observing the beginning
      and end of the trial of the Self-Rating Anxiety Scale score, the Self-Rating Depression Scale
      score, and the Breast Cancer Patients' Quality of Life Scale. At the end of the treatment, we
      take software packages SPSS 20.0 for management and statistical analysis.
    

Intervention name(s): 5-element music therapy
Intervention type(s): Behavioral
Intervention description(s): participants were treated by TCM five-phase music therapy for not less than 30 minutes per day, and group music therapy was performed every three weeks. In addition, the therapeutic schedule is composed of treatment time (1pm-2pm, 9pm-11pm), frequency treatment (two times a day), intervention (10-15 minutes in the afternoon, 30 minutes in the evening) and content (individuals: dialectical selection of music; groups: community singing, every three weeks).
Other intervention name(s): health education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: breast cancer; music therapy; Quality of Life; Depression, Anxiety