bioihbjkbjnl/mcl2 huggingface dataset:
Low Serum Ficolin-3 Levels on Admission Are Associated With Poor Outcomes After Severe Traumatic Brain Injury
Condition: Brain Injuries
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Observational

Summary: 
      The current study was designed to investigate the change of serum ficolin-3 levels and assess
      the prognostic predictive effect of serum ficolin-3 levels in the patients with severe
      traumatic brain injury.
    

Detailed description: 
      Complement activation is one of the pathological mechanisms that contribute to the secondary
      brain injury after traumatic brain injury. Ficolin-mediated lectin pathways of complement
      activation contribute to the pathogenesis of ischemic stroke and may be additive to
      complement-independent inflammatory processes. Lower serum ficolin-3 levels have been
      demonstrated to be highly associated with unfavorable outcome after ischemic stroke. This
      prospective observatory study was designed to investigate the relationship between serum
      ficolin-3 levels and 1-week mortality, 6-month mortality and 6-month unfavorable outcome
      (defined as Glasgow Outcome Scale score of 1-3) in patients with severe traumatic brain
      injury. This study recruited 128 patients and 128 sex- and age- matched healthy controls.
      Serum ficolin-3 levels on admission were measured by sandwich immunoassays. It was postulated
      that serum ficolin-3 levels were correlated with Glasgow Coma Scale scores and ficolin-3 was
      identified as an independent prognostic predictor for 1-week mortality, 6-month mortality and
      6-month unfavorable outcome. Thus, it was proposed that lower serum ficolin-3 levels,
      correlated with injury severity reflected by Glasgow Outcome Scale scores, had the potential
      to be the useful, complementary tool to predict short- or long- term clinical outcome after
      severe traumatic brain injury.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The patients with isolated head trauma and postresuscitation Glasgow Coma Scale score of 8
        or less.
      
Biospecimen description: 
      All blood samples from the patients at admission were collected in the tubes and centrifuged
      within 30 minutes at 1,000*g for 15 minutes. The serum was removed and frozen at -70°C until
      measurement.
Genotype Guided Chemotherapy in Gastric Cancer Patients
Condition: Metastatic Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      In gastric cancer patients treated with 5-FU and cisplatin, higher tumor TS levels were
      associated with a less favorable response (29% vs. 68%; p=0.024). Similarly, in a study in
      which patients were treated with high dose 5-FU, patients with high TS expression had a
      response rate of only 12.5%. Conversely a response rate of 92.9% was observed in patients
      with low tumor TS expression. A longer but not statistically significant survival advantage
      was observed in patients with the TSER*2 allele compared with the TSER*3/*3 patients.
      Additionally, a review by Patel et al. identified approximately 20 gastric cancer studies
      that have found a positive association between TSER genotype and clinical response (in either
      direction). Therefore, the primary goal of this proposal is to prospectively genotype
      patients, select patients with "good risk" TSER genotypes (TSER*2*/*2 or *2/*3) and treat
      them with a standard 5-FU containing regimen (FOLFOX) in order to improve clinical outcomes,
      while randomize patients with the "poor risk" TSER genotype (*3/*3) to either the standard
      5-FU containing regimen or another non-5-FU-based regimen (docetaxel/cisplatin).
    


Intervention name(s): TSER
Intervention type(s): Genetic
Intervention description(s): TS gene will be genotyped for each patients prior to chemotherapy. Patients will be assigned to different arms according to specific TSER genotype.
Other intervention name(s): TSER genotypes: *2/*2 *2/*3 *3/*3
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety
Condition: Healthy; Pharmacokinetics; Pharmacodynamics; Ilaprazole
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study were (a) to evaluate the pharmacokinetics and to evaluate and
      compare the pharmacodynamics of ilaprazole and esomeprazole following a single dose (Day 1)
      and once daily (QD) administration for 5 consecutive days each of 10-mg, 20-mg, and 40-mg
      ilaprazole tablets and 40-mg esomeprazole tablets; (b) to evaluate the safety of 10-mg,
      20-mg, and 40-mg ilaprazole tablets following QD oral administration for 5 consecutive days;
      and (c) to characterize the plasma gastrin concentration profile on Day 1 and Day 5 following
      QD oral administration of 10-mg, 20-mg, and 40-mg ilaprazole and 40-mg esomeprazole tablets
      for 5 consecutive days.
    


Intervention name(s): Ilaprazole; Esomeprazole
Intervention type(s): Drug; Drug
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Study Comparing the Immune Response and Safety of Fluarix and Fluzone Influenza Vaccines in Children
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare two influenza vaccines (Fluzone and Fluarix) in terms
      of the immune response elicited and safety with a six month follow-up after first
      vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment
      Act, Sep 2007.
    


Intervention name(s): Fluarix™; Fluzone
Intervention type(s): Biological; Biological
Intervention description(s): Subjects were administered 1 or 2 doses* intramuscularly, into the non-dominant upper arm for children > 12 months of age, in the anterolateral thigh for children < 12 months.
*Only those subjects between the age of 6 months and < 9 years, who had no history of prior influenza vaccination, received 2 doses at months 0 & 1.; Subjects were administered 1 or 2 doses* intramuscularly, into the non-dominant upper arm for children > 12 months of age, in the anterolateral thigh for children < 12 months.
*Only those subjects between the age of 6 months and < 9 years, who had no history of prior influenza vaccination, received 2 doses at months 0 & 1.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Fluarix; Influenza
Prophylaxis Trial in High Risk Allogenic Stem Cell Transplant Recipients With Graft vs. Host Disease
Condition: Mycoses
MeSH terms: Mycoses
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is in high risk patients to determine the safety, tolerance and efficacy of
      posaconazole (POZ) vs. fluconazole in the prophylaxis against development of invasive fungal
      infections (IFI).
    

Detailed description: 
      This study is designed to determine the safety, tolerance and efficacy of POZ used as
      prophylaxis of IFI in high-risk subjects with Grade II-IV acute graft vs. host disease (GVHD)
      or extensive chronic GVHD. The primary objective is to assess the efficacy of SCH56592 vs
      fluconazole in preventing proven or probable IFI within the time period from randomization to
      16 weeks after the start of treatment with study drug.
    

Intervention name(s): Posaconazole oral suspension
Intervention type(s): Drug
Intervention MeSH terms: Posaconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Allogenic Stem cell transplantation; Fungal infections
The Effect of Intraperitoneal Bupivacaine Versus Bupivacaine With Neostigmine on Pain in Laparoscopic Cholecystectomy
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      Injection of intraperitoneal bupivacaine revealed an analgesic effect whether injected alone
      or in combination with other adjuvants, which increase duration of analgesia and decrease the
      dose of administered bupivacaine thus minimizing its side effects e.g. Opioids,
      Corticosteroids and Magnesium sulphate.

      Neostigmine, a cholinesterase inhibitor that produces muscarinic receptor-mediated analgesia,
      increased postoperative analgesia when combined with local anaesthetics. Peripheral afferent
      nerve fibres contain muscarinic receptors, these could be a good target for pain suppression.
    

Detailed description: 
      The use of neostigmine as adjuvant to intraperitoneal bupivacaine was not previously
      investigated. In this study the investigators will compare the analgesic effect of
      bupivacaine alone and bupivacaine in combination with neostigmine when injected
      intraperitoneal in patients undergoing laparoscopic cholecystectomy.
    

Intervention name(s): Bupivacaine Hydrochloride; Neostigmine
Intervention type(s): Drug; Drug
Intervention description(s): after induction of general anesthesia and before the start of surgery, after inflating the pneumoperitoneum and before any surgical manipulation, the surgeon infuse 50 mL of blinded solution (bupivacaine or bupivacaine neostigmine) intraperitoneally to the sub-diaphragmatic space and gall bladder area guided by the camera and the patients are kept in Trendelenburg position for 5-10 minutes. Thereafter all patients will be positioned in the anti-Trendelenburg position to start the surgery and the laparoscopic procedure will be carried out in a standard fashion.; after induction of general anesthesia and before the start of surgery, after inflating the pneumoperitoneum and before any surgical manipulation, the surgeon infuse 50 mL of blinded solution (bupivacaine or bupivacaine neostigmine) intraperitoneally to the sub-diaphragmatic space and gall bladder area guided by the camera and the patients are kept in Trendelenburg position for 5-10 minutes. Thereafter all patients will be positioned in the anti-Trendelenburg position to start the surgery and the laparoscopic procedure will be carried out in a standard fashion.
Other intervention name(s): Marcaine; prostigmin
Intervention MeSH terms: Bupivacaine; Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group 1 (Bupivacaine group= B group) will receive a 50 mL solution of bupivacaine 0.25% intraperitoneal instilled solution.
Group 2 (Bupivacaine neostigmine group=BN group) will receive 500 μg neostigmine mixed with bupivacaine 0.25% with a total volume of 50 mL intraperitoneal instilled solution.
Masking: Single (Care Provider)
Primary purpose: Treatment
Aftercare for Adolescents Treated for Alcohol Abuse and Dependence
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Phase 2

Summary: 
      The study examines the relative efficacy of two active aftercare interventions (i.e.,
      face-to-face , brief phone) with no-active aftercare for adolescents who completed outpatient
      treatment for alcohol use disorders(AUD)
    

Detailed description: 
      In this study 177 adolescents meeting criteria for alcohol use disorders (AUD) received
      weekly cognitive-behavioral therapy group sessions. 144 completers were randomized into the 3
      individual aftercare (AR) conditions noted above. Manualized active interventions were
      composed of 5 sessions of integrated motivational enhancement and cognitive behavioral
      therapies. Outcomes assessments were done at end of aftercare, 3-6-and 12 months post AC
      completion.
    

Intervention name(s): Brief phone aftercare intervention; individual aftercare therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Interventions is composed of 5 integrated cognitive-behavioral and motivational enhancement therapies administered during a period of 3 months according to a similar schedule; composed of 5 integrated cognitive-behavioral and motivational enhancement Therapies administered during a period of 3 months according to a similar schedule
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: alcohol; alcohol use disorder; cognitive-behavioral therapy; brief phone aftercare intervention; individual aftercare therapy
Executive, Activities of Daily Living, and Cholinergic Functions in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      This research study will evaluate functions of memory, thinking, behavior, and daily life
      activities and how these relate to the measurement of certain chemicals (acetylcholine and
      dopamine) in the brain using an imaging procedure called positron emission tomography (PET).
      You may know that in Alzheimer's dementia (dementia is a disease where persons become
      forgetful and confused), a reduction in the amount of acetylcholine, a "neurotransmitter"
      substance (a chemical messenger that nerve cells need to communicate with each other), may be
      responsible for some of the memory and behavioral changes. At the present time, the
      investigators have no clear information on the levels of acetylcholine in the brain of
      patients with Parkinson's disease who also have memory or behavioral changes.
    


Intervention name(s): Behavioral assessment/questionnaire
Intervention type(s): Behavioral
Intervention description(s): Complete behavioral assessment/questionnaire
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Parkinson's disease, either with or without memory or concentration
        difficulties, and normal control persons between the ages of 50-85 years are eligible to
        participate in this study. Participants should be willing and able to comply with study
        requirements. Normal control persons should not have a history of brain or mental
        disorders. Both males and females are eligible.
The Therakos UVAR Photopheresis System in the Treatment of AIDS-Related Complex
Condition: HIV Infections
MeSH terms: AIDS-Related Complex
Study type: Interventional

Summary: 
      To determine the safety and patient tolerance of UVAR Photopheresis System (extracorporeal
      photopheresis) in the Treatment of AIDS-Related Complex (ARC).
    

Detailed description: 
      Treatment involves the patient ingesting 8-methoxsalen (8-MOP) by mouth approximately two
      hours prior to each photopheresis session. The photopheresis instrument will separate the
      patient's white blood cells and some plasma from other blood components and return the
      majority of blood components to the patient. The separated white blood cells and plasma will
      be exposed to UVA (Ultraviolet A) light while outside the body. The UVA light photoactivates
      the 8-MOP drug which is now located in the DNA of the collected cells. After this exposure,
      the patients photoactivated white blood cells will be returned to the patient by venous
      access.
    

Intervention name(s): Methoxsalen
Intervention type(s): Drug
Intervention MeSH terms: Methoxsalen
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PUVA Therapy; Methoxsalen; AIDS-Related Complex
Compare the Efficacy and Safety of Raltegravir Versus Efavirenz Combination Therapy in Treatment-naïve HIV-1 Patients
Condition: HIV-1 Infection
MeSH terms: Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      A pilot study to compare the efficacy and safety of raltegravir-based versus efavirenz-based
      combination therapy in treatment-naïve patients with HIV-1 infection.
    

Detailed description: 
      A single-center, prospective, randomized, open label, parallel study to compare the efficacy
      and safety of raltegravir-based versus efavirenz-based plus optimal nucleoside
      reverse-transcriptase inhibitors(NRTIs) backbone combination therapy in treatment-naïve
      patients with HIV-1 infection.
    

Intervention name(s): Raltegravir; Efavirenz
Intervention type(s): Drug; Drug
Intervention description(s): Raltegravir 400mg oral twice daily; Efavirenz 600mg oral at bedtime
Other intervention name(s): Isentress; Stocrit
Intervention MeSH terms: Efavirenz; Raltegravir Potassium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Efavirenz; Raltegravir; Combination antiretroviral therapy
Post-Exercise Hypotension After Water Exercise
Condition: Postexercise Hypotension
MeSH terms: Post-Exercise Hypotension; Hypotension
Study type: Interventional

Summary: 
      Hypertension is the most prevalent cardiovascular disease risk factor among individuals 60
      years of age and older. Hypertension can be prevented and modified with lifestyle
      interventions that include regular exercise. Water exercise is widely recommended for older
      adults for a variety of health benefits, but few studies have assessed the immediate
      ambulatory blood pressure (BP) response to water exercise, a response termed postexercise
      hypotension (PEH). We will assess PEH after a session of water aerobics in physically active,
      older women with hypertension. Twenty-four women will be randomly assign to participate in a
      45 min session of moderate intensity, water aerobics (WATER) and a 45 min land control
      session (CONTROL). All experimental sessions will start at 9 am sharply with 7 days between
      them. Subjects will left the experiments wearing an ambulatory BP monitor for the next 21 hr.
    


Intervention name(s): Water aerobic exercise session (WATER)
Intervention type(s): Other
Intervention description(s): A continuous session of dynamic water aerobic exercise which consist of a dynamic warm-up period (5 minutes), an active exercise period (35 minutes), and a cooldown period (5 minutes) to total 45 minutes. Heart rate (HR) will be continuously measured with heart monitors (Polar) to confirm the intensity of the WATER session. The WATER intensity will be calculated according to the formula proposed by Kruel for exercise in an aquatic environment18 as follows: HR for exercise = % x (HRmax - ΔHR); % is the intensity of exercise; HRmax is the maximum HR (estimated by 220 - age); ΔHR represents the difference between resting HR on land and resting HR in the water environment. Exercise intensities: 55-60% HRmax during warm-up; 70-75% HRmax during active exercise; and 55-60% HRmax during cooldown.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effect of Rowachol on Prevention of Postcholecystectomy Syndrome
Condition: Postcholecystectomy Syndrome
MeSH terms: Postcholecystectomy Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Postcholecystectomy syndrome (PCS) includes a heterogeneous group of diseases, usually
      manifested by the presence of abdominal symptoms following gallbladder removal. The
      pathogenesis of PCS has not been identified; therefore there is no consensus of medical
      treatment on PCS. The Action of Rowachol are to inhibit hepatic 3-hydroxy-3-methylglutaric
      acid(HMG)-coenzyme A(CoA) reductase, to inhibits cholesterol nucleation in bile from patients
      with cholesterol gallstones, and to promote biliary lipid secretion.

      The purpose of this study is to determine whether Rowachol is useful in the prevention of PCS
      and symptoms change after laparoscopic cholecystectomy
    


Intervention name(s): Rowachol; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: postcholecystectomy syndrome; laparoscopic cholecystectomy; Rowachol
Nurigra Chewable Tablet in Healthy Adult Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate pharmacokinetics of sildenafil citrate in healthy
      male volunteers.
    


Intervention name(s): Nurigra Chewable tablet
Intervention type(s): Drug
Intervention description(s): 1 tablet of 100mg, once a day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Safety and Tolerability Study of MBX-2044 in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to collect important information regarding the glucose-lowering
      efficacy of MBX-2044 and the safety of MBX-2044 (especially weight gain and edema) in
      diabetics. It will also provide important information about the appropriate doses to be used
      in subsequent longer-term studies to evaluate the safety and efficacy of MBX-2044 alone and
      in combination with other anti-diabetic agents.
    

Detailed description: 
      The current study is designed to test the short-term effectiveness and tolerability of
      MBX-2044 in patients with type 2 diabetes who are currently being controlled with up to one
      or two non-TZD hypoglycemic agent(s) including sulfonylureas, meglitinides, metformin,
      α-glucosidase inhibitors or Byetta®. Eligible patients will be enrolled into one of the
      following treatment cohorts receiving either placebo or MBX-2044 at 1.5, 4.5, 15, 30, or 60
      mg/day in a double-blinded study for a 14-day treatment period. Patients will be evaluated
      for adverse events and vital signs daily. All efficacy and laboratory safety measures will be
      assessed after 2 weeks. This study will provide important information regarding the
      glucose-lowering efficacy of MBX-2044 and the safety of MBX-2044 (especially weight gain and
      edema) in diabetics. It will also provide important information about the appropriate doses
      to be used in subsequent longer-term studies to evaluate the safety and efficacy of MBX-2044
      alone and in combination with other anti-diabetic agents.
    

Intervention name(s): MBX-2044; MBX-2044; MBX-2044; MBX-2044; MBX-2044; MBX-2044; Placebo for MBX-2044
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): MBX-2044 1.5 mg one capsule daily for 14 days; MBX-2044 4.5 mg three 1.5 mg capsules daily for 14 days; MBX-2044 15 mg one capsule daily for 14 days; MBX-2044 30 mg two 15 mg capsules daily for 14 days; MBX-2044 60 mg one capsule daily for 14 days; MBX-2044 90 mg one 60 mg capsule and two 15 mg capsules daily for 14 days; Placebo Intervention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus