bioihbjkbjnl/mcl2 huggingface dataset:
Fast-track Rehabilitation After Elective Colorectal and Small Bowel Resection
Condition: Colorectal Tumor
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to address the question of whether or not oral alimentation and
      ambulation exercise should be begun early in patients following laparoscopic colorectal
      surgery compared to the classical diet and ambulation which depends on reappearance of
      functional intestinal transit. Early oral alimentation following laparoscopic colorectal
      surgery may decrease hospital stay and facilitate earlier discharge with comparable
      postoperative morbidity.
    

Detailed description: 
      Traditionally, patients who received laparoscopic colorectal surgery were treated with the
      classical protocol including the use of a naso-gastric tube and starvation for several
      postoperative days till the recovery of bowel movement, or bed resting at immediate
      postoperative period followed by ward ambulation at the postoperative day 1 or 2. Restarting
      the oral alimentation is based on gas or feces reappearance after surgery and usually this is
      possible at several days following surgery. However, prolonged starvation might be
      uncomfortable for the patient as well as increasing his postoperative hospital stay.
      Recently, several studies reported the efficacy of early rehabilitation protocols after
      intestinal surgery, showing that early oral alimentation could reduce the length of hospital
      stay and cost of hospitalization without significant increase of postoperative complications,
      compared to traditional management.

      This prospective, randomized study was designed to evaluate the effectiveness of a
      postoperative care pathway using rehabilitation with early ambulation and diet for patients
      undergoing elective laparoscopic colorectal resection compared with the traditional
      postoperative care.

      In order to conduct this study, patients having a laparoscopic colon resection will be
      randomly attributed to enhanced recovery program group or control group, which is divided
      based on the postoperative management protocol.
    

Intervention name(s): fast-track rehabilitation
Intervention type(s): Behavioral
Intervention description(s): fast-track rehabilitation with early ambulation and diet after elective colorectal resection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: enhanced recovery program
The Predictors and Patient Versus Parental Perceptions of Health-Related Quality of Life in Pediatric Chronic Pain
Condition: Pediatric Chronic Pain
MeSH terms: Chronic Pain
Study type: Observational

Summary: 
      This study is intended to provide additional insight into the factors affecting
      health-related quality of life with pediatric chronic pain as perceived by the patient versus
      his or her parents.In doing so, additional insight into the subjective interpretation the
      pediatric chronic pain experience will be gained. The four objectives of this study will be
      (a) to examine further the relationship between patient self-reported health-related quality
      of life and parent proxy-reported health-related quality; (b) to identify what biological,
      psychological, and/or social factors are the strongest predictors of a pediatric chronic pain
      patient's self-reported pain intensity and self-reported health-related quality of life, in a
      diverse cohort of patients referred to and subsequently treated by an anesthesiology-based
      yet interdisciplinary pediatric chronic pain medicine program; (c) to assess the effect of
      patient-specific, pain-focused biopsychosocial treatment regimen on pain intensity and
      health-related quality of life; and (d) to determine the effect of patient/parental
      satisfaction with on-going health care on their compliance with and uptake of the pain
      treatment regimen.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will come from those patients evaluated and treated in the Pediatric Chronic
        Pain Medicine Clinic at the Children's Hospital facilities. The likely study population
        includes essentially the pediatric population of the entire state of Alabama and
        immediately adjacent states (i.e., the geographic catchment area of the Children's Hospital
        of Alabama).
A Pre-surgical Study of LDE225 in Men With High-risk Localized Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is designed as a randomized two-arm (LDE225 vs. observation groups) open-label
      prospective clinical trial in men with localized high-risk prostate cancer undergoing radical
      prostatectomy.

      The investigators propose to determine the effects of LDE225 on neoplastic prostate tissue
      from men at high risk of systemic disease progression, by comparing pre-surgical core-biopsy
      specimens to tumor tissue harvested at the time of prostatectomy.
    

Detailed description: 
      High-risk patients will be identified based on their core-needle biopsy features, PSA levels,
      and clinical stage. After obtaining baseline laboratory and clinical values (including an
      ECG, PSA, hematologic, and renal and hepatic panels), men will receive oral LDE225 800 mg/day
      or observation daily for 4 weeks (±3 days) prior to prostatectomy. Patients will have a
      clinical visit and an ECG and laboratory testing will be performed at 2 weeks and then again
      at 4 weeks, including a 4-week pre-prostatectomy measurement of PSA and a blood sample to
      determine plasma LDE225 levels. Men will undergo radical prostatectomy (with bilateral pelvic
      lymphadenectomy as appropriate), at which point two 250-mg biopsies of prostate tissue will
      be obtained, frozen and stored for analysis.
    

Intervention name(s): LDE225
Intervention type(s): Drug
Intervention description(s): Sonidegib was given as an oral drug at 800mg daily for 28 days prior to prostetoctomy
Other intervention name(s): Sonidegib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LDE225; High risk localized prostate cancer; Pre-surgical
Metabolic Adaptation to Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Hypoglycemia or low blood sugar is a very serious complication that diabetics experience.
      This is of great concern because there is a lack of available information of how Non Insulin
      Dependent Diabetic Mellitus patients (NIDDM) defend themselves against a low blood sugar.
      This is particularly disturbing since NIDDM patients are likely to require intensive
      treatment, and as a result, the risks of severe hypoglycemia to the NIDDM patient increase.
      The current proposal aims to provide information on how NIDDM patients can defend themselves
      against hypoglycemia, thus decreasing their risks for this severe complication.
    

Detailed description: 
      There is very little data available on the neuroendocrine response to hypoglycemia in
      intensively treated (sulfonylurea or insulin) NIDDM patients. The data that are available on
      the neuroendocrine response to hypoglycemia in NIDDM patients were obtained under conditions
      following a single IV bolus of insulin or single SQ regular insulin injection. The
      neuroendocrine response following a large IV bolus of insulin differs greatly from the
      clinical paradigm of a slow progression into hypoglycemia. Therefore, clinically relevant
      data cannot be obtained from short experiments involving rapid changes in plasma glucose
      levels and insulinemia. Furthermore, a comparison between neuroendocrine responses to
      hypoglycemia in NIDDM and normal man is not available due to the fact that glycemia has never
      been equally controlled. In short, virtually nothing is known about the neuroendocrine
      response to hypoglycemia in these subjects. This is of great concern as following the
      positive outcome of the Kumamato study, large numbers of NIDDM subjects are going to receive
      intensive therapy with all its altendent risks of severe hypoglycemia. The Kumamato study was
      a trial in NIDDM patients to determine if intensive therapy reduces tissue complications of
      diabetes. Similar to the results of the Diabetes control and complications trial in IDDM
      patients the Kumamato study proved that intensive therapy in NIDDM patients also prevents
      diabetic tissue complications. Therefore, the goals of this study are 1) to define in greater
      detail how the body defends itself against hypoglycemia in NIDDM patients and 2) to determine
      if differing levels of insulin affect hypoglycemic counterregulation in NIDDM patients.
    

Intervention name(s): glucose clamp; glucose clamp
Intervention type(s): Procedure; Procedure
Intervention description(s): Hyperinsulinemic Hypoglycemic clamp; Hyperinsulinemic Hypoglycemic clamp
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 diabetes; intensive therapy
Analgesic Effect of Ropivacaine Plus Fentanyl vs Ropivacaine for Continuous 3-in-1 FNB After Total Knee Arthroplasty
Condition: Pain
Study type: Interventional

Summary: 
      The postoperative analgesic effect of the continuous 3-in-1 femoral nerve block (FNB) with
      ropivacaine/fentanyl or with ropivacaine were compared in total knee arthroplasty.
    

Detailed description: 
      Forty patients of American Society of Anesthesiologist physical status Ⅰor Ⅱ undergoing total
      knee arthroplasty under spinal anesthesia would be enrolled and randomly divided into two
      groups (R, "3-in-1" using a 30 ml of ropivacaine 0.375% and a continuous 3-in-1 with a
      ropivacaine 0.2%(8mL/h) for 48 h after operation, RF: Fifty ug of fentanyl will be added to a
      bolus(30ml ropivacaine 0.375%) and 1ug/ml of fentanyl will be mixed to a continuous
      infusion(8mg/h, ropivacaine 0.2%). Spinal anesthesia will be done after the insertion of
      femoral catheter. IV PCA with hydromorphone(0.15mg/ml, 0-1-10), will be used for rescue
      analgesics. Visual analgesia scale, hydromorphone consumption, side effects until 48h after
      operation and satisfaction will be compared.
    

Intervention name(s): Femoral nerve block with ropivacaine+fentanyl; Femoral nerve block with ropivacaine
Intervention type(s): Drug; Drug
Intervention description(s): Ropivacaine+fentanyl are used for continuous femoral nerve block, spinal anesthesia, IV-PCA with hydromorphone; Ropivacaine is used for continuous femoral nerve block, spinal anesthesia, IV-PCA with hydromorphone
Other intervention name(s): RF; R
Intervention MeSH terms: Fentanyl; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
The Diagnostic and Prognostic Value of Presepsin in Sepsis
Condition: Septic Shock
MeSH terms: Shock, Septic
Study type: Interventional

Summary: 
      Intra-abdominal infections are a common cause of sepsis and frequently occur in intensive
      care unit (ICU) patient. Various markers such as procalcitonin, presepsin and endotoxin are
      used to identify patients at risk of sepsis or to guide proper treatment.

      No studies compared presepsin to procalcitonin and endotoxin in patients treated with by
      extracorporeal hemoperfusion with a polymyxin-B-adsorbing cartridge (PMX-HA).
    

Detailed description: 
      Intra-abdominal infections are a common cause of sepsis and frequently occur in intensive
      care unit (ICU) patient. Various markers such as procalcitonin, presepsin and endotoxin are
      used to identify patients at risk of sepsis or to guide proper treatment. Particularly,
      endotoxin can be removed from the blood by extracorporeal hemoperfusion with a
      polymyxin-B-adsorbing cartridge (PMX-HA).

      No studies compared presepsin to procalcitonin and endotoxin in patients treated with PMX-HA.
      The investigators aim to evaluate the trend and prognostic value of presepsin versus
      procalcitonin and endotoxin in ICU patients with septic shock from complicated major
      abdominal surgery, treated with PMX-HA.
    

Intervention name(s): presepsin, procalciton, endotoxin
Intervention type(s): Diagnostic Test
Intervention description(s): measurement of presepsin, procalciton, endotoxin plasmatic levels
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: septic shock
The Effect of Fatima Ana's Hand on Birth Pain and Duration
Condition: Labor Pain; Labor Long
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      Research Question: Does the Anastatica Hierochuntica have an effect on labor pain and
      duration? Methods: This study was planned as a a double blind randomized controlled
      experimental study. The study was conducted with 60 pregnant women who were randomized
      between February 2019 and November 2020 at a university and private hospital located in
      Anatolia, Turkey.
    

Detailed description: 
      Complementary treatment methods during the birth process are supportive therapies. It is
      applied to meet the physical and psychological care needs, to help cope with pain during
      childbirth, to increase the quality of life of pregnant women. Mind-body methods, alternative
      medical methods, biological-based treatment methods, manipulative and body-based methods, and
      energy therapy methods are used as complementary treatment methods in labor. The focus
      applied within the scope of mind-body methods is based on the principle of revealing the
      mental skill that improve bodily functions. One of the methods applied in this direction is
      Anastatica Hierochuntica.

      Anastatika Hierochuntica is a herbaceous plant that can live 1000-2000 years, with dry leaves
      resembling a fist-closed hand in which it stores its seeds. Known as "Fatma Ana Eli" or
      "Meryem Ana Eli". This dry ball-shaped plant in the deserts of Namibia comes alive in the
      rain and turns to green color by opening the folds. After the rain, the leaves of the plant,
      which stores some water to pass through a new drought period, close again and take a dry
      appearance.

      The plant Anastatica Hierochuntica is known to have a facilitating effect on labor and is
      frequently used for this purpose during labor. During childbirth, the Anastatica
      Hierochuntica plant is dropped into a bowl of water. It is believed that as the plant opens,
      labor will be easier, and the baby will flow like water.

      Despite its frequent use, when the literature is examined, no studies hasve been found on the
      effect of Anastatica Hierochuntica on birth. For this reason, the study was conducted to
      evaluate the effect of Anastatica Hierochuntica on labor pain and duration.
    

Intervention name(s): Anastatica Hierochuntica
Intervention type(s): Behavioral
Intervention description(s): During the sampling process, the researcher inquired through women who apply for pregnancy follow-up and contacted the mothers who had some inclusion criteria. Also, the researcher outlined the research plan and objectives. The participants were assessed based on the eligibility criteria and, if they were eligible and willing to participate in the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Labor pain; Labor duration; Midwife; Anastatica Hierochuntica
Monitoring Stomach Function With an Intragastric Balloon - a Pilot
Condition: Functional Disorders of Stomach
MeSH terms: Stomach Diseases
Study type: Interventional

Summary: 
      In this pilot study the investigators test the hypothesis that gastric motility can be
      measured with an intragastric balloon.
    


Intervention name(s): intragastric bag
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Evaluation of Correct PEP Use With the Time
Condition: Healthy
Study type: Interventional

Summary: 
      Healthy subjects will be trained to used correctly a positive expiratory pressure device. The
      aim of the study is to evaluate te reproductibility of the correct used of the device after
      training
    


Intervention name(s): Positive expiratory pressure
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Development and Acceptability Testing of Ready-to-use-complementary Food Supplement (RUCFS) for Children in Bangladesh
Condition: Moderately Malnourished Children
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The prevention of malnutrition among children under 5 years of age requires consumption of
      nutritious food, including exclusive breast feeding for the first six months of life,
      followed by breastfeeding in combination with complementary foods thereafter until at least
      24 months of age; a hygienic environment; access to preventive as well as curative health
      services, and good prenatal care. The proposed research is on the possible options for
      providing a nutritious diet, realizing the constraints of poverty and food insecurity faced
      by care givers whose children are at risk of developing or confirmed to be suffering from
      moderate malnutrition. Even when people are not typically food insecure but consume a
      relatively monotonous diet with few good-quality foods, they also have to have options for
      dietary improvement, and especially the possibility of ready-to-use complementary food
      supplements (RUCFS) for young children. This proposed research on development of RUCFS will
      pave the way for programmatic considerations for expansion of the use of new complementary
      food supplements for preventing malnutrition among young children in Bangladesh.
    


Intervention name(s): Pushti packet; Rice based Ready to Use Complementary Food Supplements; Chick-pea based Ready to Use Complementary Food Supplements
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): A food composed of roasted rice, roasted lentil, molasses and soybean oil; A rice based diet.; A chick-pea based diet.
Other intervention name(s): A food composed of roasted rice, roasted lentil, molasses and soybean oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
A Study to Assess the Pharmacokinetics, Safety and Tolerability of Repeat Oral Doses of Darapladib (SB-480848) in Subjects With Severe Renal Impairment
Condition: Atherosclerosis
MeSH terms: Renal Insufficiency; Atherosclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      In accordance with the recently revised FDA draft renal impairment guidance (March 2010)
      which advises the conduct of renal impairment study in drugs that are not predominately
      eliminated through the renal route, the proposed study will be conducted to formally assess
      the pharmacokinetics (PK) of darapladib in severely renally impaired subjects.

      In this is an open-label, non-randomized study eight subjects with severe renal impairment
      will be recruited along with 8 healthy control subjects matched to the severe renal
      impairment subjects based on gender, body mass index (plus or minus 20%) and age (plus or
      minus 10 years).

      All subjects will receive repeat oral doses of darapladib 160 milligram (mg) for 10
      consecutive days. The pharmacokinetics of darapladib and its metabolites; and safety and
      tolerability will be evaluated.

      All the subjects will be admitted to the clinic on the evening of Day -1. Subjects may check
      out of the clinic on Day 2 after all assessments are complete, but must return to the clinic
      each day (Days 3-8) for dosing and assessments. Subjects will be admitted to the clinic again
      on the evening of Day 9. After the last dose of the study drug, there will be a follow-up
      period which will include 2 visits (Day 20-24 and Day 38-52). The total study duration for
      each subject including the screening, treatment and follow-up periods will be approximately
      11 weeks.
    


Intervention name(s): Darapladib 160 mg
Intervention type(s): Drug
Intervention description(s): Subjects in each group received one tablet orally of Darapladib 160 mg daily for 10 consecutive days. Tablets were taken with food, swallowed whole, not chewed.
Intervention MeSH terms: Darapladib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: darapladib; Lp-PLA2- inhibitor; healthy volunteer; renal impairment; pharmacokinetics
Effectiveness of Manual Lymphatic Drainage in Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Manual Lymphatic Drainage is a widely used technique for lymphedema. However, the analgesic
      effects of this technique could be potentially useful for managing pain in patients with
      generalized widespread chronic pain, including patients with fibromyalgia.
    


Intervention name(s): Manual Lymphatic Drainage
Intervention type(s): Other
Intervention description(s): Manual lymphatic drainage is a technique that through gentle passes facilitates the flow of lymph through manual therapy techniques based on Vodder therapy. This technique is being studied to know its effectiveness in pain and for this reason we want to carry out this research.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Manual Lymphatic Drainage; Randomized clinical trial; Pain
Clinical Study to Evaluate the Pharmacokinetics and Safety of BDP HFA Nasal Aerosol
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the systemic levels of beclomethasone 17
      monopropionate (17 BMP - the active metabolite of BDP) after intranasal administration of BDP
      HFA with the systemic levels of 17 BMP after administration of orally inhaled BDP HFA in
      healthy volunteers.
    


Intervention name(s): BDP HFA Nasal Aerosol; BDP HFA Nasal Aerosol; BDP HFA Inhalation Aerosol (QVAR)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): BDP HFA Nasal 80mcg; BDP HFA Nasal 320mcg; BDP HFA Oral 320mcg
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
A Study of LY2940094 in Participants With Alcohol Dependency
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this study is to evaluate a once daily (QD) 40-milligram (mg) oral dose
      of LY2940094 in participants with an alcohol dependency to evaluate if LY2940094 will reduce
      alcohol drinking in these participants. The study will last for 8 weeks.
    


Intervention name(s): LY2940094; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment