bioihbjkbjnl/mcl2 huggingface dataset:
Narcotics vs NSAIDs for Post-operative Analgesia in Outpatient Rhinoplasty
Condition: Rhinoplasty; Non-steroidal Ant Inflammatory Drugs; Opioid Use
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the efficacy and safety of oral opiate pain
      medication vs non-steroidal ant inflammatory drugs (NSAIDs) in the treatment of postoperative
      rhinoplasty pain. This study will also evaluate potential contributing factors affecting the
      efficacy of these pain control methods. Patients will be randomized to receive either NSAIDs
      in the form of 400mg of Ibuprofen or Norco (hydrocodone 5mg- acetaminophen 325mg) to be used
      for post-operative pain. The study will then compare which is more effective in controlling
      post operative pain.
    


Intervention name(s): Norco; NSAID
Intervention type(s): Drug; Drug
Intervention description(s): 20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco); Ibuprofen 400mg for post-operative pain
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
IN10018 Monotherapy or in Combination With Docetaxel in Gastric or GEJ Adenocarcinoma
Condition: Gastric Cancer
MeSH terms: Adenocarcinoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, multi-center clinical trial to evaluate the safety, tolerability,
      antitumor activities and pharmacokinetics of IN10018 as monotherapy or in combination with
      docetaxel in previously-treated locally advanced or metastatic gastric or gastroesophageal
      junction (GEJ) adenocarcinoma.
    

Detailed description: 
      Eligibility patients will be enrolled into the study and assigned to treatment groups: 1)
      IN10018 monotherapy group, and 2) IN10018+Docetaxel combination group. This study contains 2
      parts of dose escalation and dose expansion for each treatment group. The monotherapy group
      will enroll patients failed to respond to standard therapy or standard or curative therapy
      does not exist or is not tolerable, and explore IN10018 monotherapy RP2D with the starting
      dose of IN10018 100mg QD per 3+3 design. The combination group will enroll patients who have
      disease progression within 3 months after at least first-line therapy, and explore
      IN10018+docetaxel RP2D with the starting dose of IN10018 100mg QD + docetaxel 75mg/m2 per 3+3
      design. The dose expansion part will start after attaining the RP2D of IN10018 monotherapy
      and IN10018+docetaxel combination therapy.
    

Intervention name(s): IN10018; Docetaxel
Intervention type(s): Drug; Drug
Intervention description(s): IN10018 orally once daily at approximately the same time each day, to ensure a dose interval of approximately 24 hours.; Docetaxel 75mg/m2 every 21 days a cycle.
Intervention MeSH terms: Docetaxel
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vascular and Metabolic Effects of Omega-3 Fatty Acids
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators hypothesize that omega does-dependently improves vascular and insulin
      resistance.
    


Intervention name(s): placebo; omega
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: insulin resistance
Faith Moves Mountains: An Appalachian Cervical Cancer Prevention Project
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a faith-placed lay health advisor
      intervention is effective in increasing use of Pap smears among middle-aged and older
      Appalachian women.
    

Detailed description: 
      Project development relied on principles of community based participatory research.
      Participants were recruited from faith institutions in four distressed Appalachian Kentucky
      counties. Investigators at the University of Kentucky worked closely with local staff who
      implemented study procedures in the field.
    

Intervention name(s): Lay health advisor visits and newsletter
Intervention type(s): Behavioral
Intervention description(s): The focus of the intervention was on reducing participants' self-identified barriers to obtaining Pap tests.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Papanicolaou test; Cervical cancer screening; Randomized controlled trial; Faith-placed; Appalachia
Bioequivalence Study of Desloratadine and Pseudoephedrine Sulfate Extended-release Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label randomised, 2-way crossover, comparative bioequivalence study.
    

Detailed description: 
      The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's
      Laboratories Ltd., India, desloratadine-pseudoephedrine and Schering Corporation,
      U.S.A.(Clarinex-D® 24-HOUR), desloratadine-pseudoephedrine, administered as a 1 x 5 mg/240 mg
      extended-release tablet under fasting conditions. The treatment phases were separated by a
      washout period of 14 days. 34 subjects(19 males and 15 females) were dosed and were enrolled
      in the study; 31 of these enrolled subjects completed the study.
    

Intervention name(s): Desloratadine and pseudoephedrine
Intervention type(s): Drug
Intervention description(s): Desloratadine and pseudoephedrine 5/240 mg
Other intervention name(s): Clarinex D-24
Intervention MeSH terms: Pseudoephedrine; Ephedrine; Desloratadine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Desloratadine and pseudoephedrine; crossover
Eflornithine in Treating Patients At High Risk of Developing Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
      development of cancer. The use of eflornithine (DMFO) may be an effective way to prevent the
      development of prostate cancer.

      PURPOSE: Randomized phase II trial to determine the effectiveness of eflornithine in
      preventing prostate cancer in patients who are at high risk of developing the disease.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the levels of polyamines (putrescine, spermidine, and spermine) and
           progression-related genes in the prostate tissue of patients at high genetic risk for
           prostate cancer treated with eflornithine (DFMO) vs placebo.

        -  Determine the side effects of DFMO and compare them with the biological effect on the
           prostate gland in these patients.

      OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
      stratified according to age (35 to 60 vs 61 to 70) and presence of localized cancer (yes vs
      no).

      All patients receive oral placebo daily for 4 weeks. Patients who are compliant and take the
      placebo 5-7 days each week are randomized to one of two arms.

        -  Arm I: Patients receive oral placebo daily.

        -  Arm II: Patients receive high-dose oral eflornithine (DFMO) daily. Treatment continues
           for 1 year in the absence of unacceptable toxicity.

      PROJECTED ACCRUAL: A total of 100 patients (50 per arm) will be accrued for this study within
      3 years.
    

Intervention name(s): eflornithine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Take 500mg of DFMO per day for 12 months; Take placebo per day for 12 months
Other intervention name(s): Difluoromethylornithine (DFMO)
Intervention MeSH terms: Eflornithine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: stage I prostate cancer
Evaluation and Classification of Foot Medial Longitudinal Arch Height in Adults
Condition: Pes Planus
MeSH terms: Flatfoot
Study type: Observational [Patient Registry]

Summary: 
      The aim of the study is, to evaluate and classificate the medial longitudinal arch height in
      adult individuals. Aged between 18-40 years,350 adults who are voluntarily participate is
      going to be evaluate with Feiss Line(FL), Navicular Drop(ND) and Longitudinal Arch Angle(LAA)
      in subtalar neutral and resting position. Maximum, minimum values are going to be calculated.
      The 95% and 68% prediction intervals will be used as cut off limits.
    

Detailed description: 
      The aim of the study is, to evaluate and classificate the medial longitudinal arch height in
      adult individuals.

      Aged between 18-40 years,350 adults who are voluntarily participate is going to be evaluate
      with Feiss Line(FL), Navicular Height(NH) and Longitudinal Arch Angle(LAA) in subtalar
      neutral and resting position. Maximum, minimum values are going to be calculated.

      Participant's height, weight and foot length, from posterior aspect of calcaneus to the
      longest toe's tip, will be measured. Center of the medial malleolus, the navicular tuberosity
      and the head of the first metatarsal bone will be marked with a CD marker. With these
      landmarks in foot's relaxed position, neutrally, FL, NH and LAA will be measured by a ruler.

      Feiss Line is a drawn line between the center of the medial malleolus to the head of the
      first metatarsal bone and then perpendicular line distance between this line and the
      navicular tuberosity will be drawn.The vertical line between the ground and the tubercle
      indicates Navicular Height. Center of goniometer placed at the navicular tuberosity then
      goniometer arms follow the medial malleolus and the head of the first metatarsal bone, degree
      between two arms indicates Longitudinal Arch Angle.

      FL, NH, LAA mean values will be calculated. The 95% and 68% prediction intervals will be used
      as cut off limits.
    

Intervention name(s): evaluation
Intervention type(s): Other
Intervention description(s): evaluation and classification of medial longitudinal arch height of foot in adults
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Individuals that ages between 18-60 (adults), healthy male and female
      
Keywords: Feiss line; Medial longitudinal arch; Navicular drop; Pes planus
Effect of Dexmedetomidine and Bupivacaine for Paravertebral Block
Condition: Fracture of Proximal Femur
MeSH terms: Fractures, Bone
Study type: Interventional

Summary: 
      Fracture femur is a common that results in severe pain. Many methods of regional and
      peripheral analgesia have been described to treat such pain. In this study the investigators
      consider using paravertebral block to treat post-fracture pain. Additionally, they consider
      adding dexmedetomidine to the used local anesthetic solution to prolong the duration of this
      block and hence postoperative analgesia.
    

Detailed description: 
      Fracture femur is a common injury which is associated with excruciating pain . This pain is
      one of the most important causes of postoperative morbidity and mortality when it is
      insufficiently treated pain. Pain induces neuroendocrine stress response causing problems
      like as reduction in vital capacity, pneumonia, tachycardia, hypertension, myocardial
      ischemia and even infarction. These problems can be prevented by successful management of
      postoperative pain.

      In patients with proximal femoral fracture, the use of paravertebral blockade produces
      reliable level of analgesia without need for additional nursing skills or monitoring in the
      postoperative period. Paravertebral blockade by injection local anesthetic solution alongside
      the vertebral column produces ipsilateral analgesia.

      Currently available local anesthetics as bupivacaine may not provide reliable periods of
      analgesia resulting in block resolution before the period of worst postoperative pain. The
      use of a large volume of local anesthetic is one of methods to overcome this problem that may
      lengthen the duration of analgesia but at increased risk of local anesthetic toxicity. Adding
      adjuvants is another potential alternative.

      Dexmedetomidine, a selective α 2 agonist, has been used to prolong the duration of analgesia
      of nerve blocks. Dexmedetomidine has also been reported to enhance central and peripheral
      nerve blockade. Alpha adrenoceptors located at the nerve endings have a possible role in the
      analgesic mechanisms by preventing norepinephrine release. The spinal mechanism is the
      principle mechanism for the analgesic action of dexmedetomidine.
    

Intervention name(s): Bupivacaine; Mixture of bupivacaine and dexmedetomidine
Intervention type(s): Drug; Drug
Intervention description(s): Paravertebral blockade will be performed using combined mixture of bupivacaine 0.5% and water soluble radio-opaque dye.; Paravertebral blockade will be performed using combined mixture of bupivacaine 0.5%, water soluble radio-opaque dye, and1 ug/kg of dexmedetomidine
Intervention MeSH terms: Dexmedetomidine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Iron and Pollen Allergy in Women
Condition: Allergy Pollen; Healthy
MeSH terms: Rhinitis, Allergic, Seasonal; Hypersensitivity
Study type: Interventional

Summary: 
      Iron deficiency and anemia are clearly associated with the onset of allergy and allergic
      diseases, whereas an improved iron status seems to prevent the onset of allergy in humans.
      Iron-deficiency can be absolute or functional. Functional iron-deficiency occurs during
      immune activation and may be reflective for the hyperactive state of atopic subjects.

      The investigators plan a prophylactic dietary intervention study in atopic/allergic and
      non-allergic individuals that transport chelated iron to immune cells. Over the course of six
      months, oral supplementation of placebo or whey protein-bound chelated iron will be given and
      1) clinical reactivity 2) iron status and 3) changes in the microflora due to the treatment
      will be assessed.
    

Detailed description: 
      There is no state-of-the-art prophylactic treatment for atopy. Once allergy develops,
      allergens should be avoided, and specific allergen immunotherapy applied. The initial cause
      of the onset of allergy, namely the immune hyperactive state of the atopic subjects, is not
      addressed at all. The investigators hypothesize that atopy is defined by a mild functional
      iron deficiency and that improving the iron status of immune cells will decrease the
      reactivity of these cells.

      In this prophylactic dietary intervention study oral supplementation of placebo or chelated
      and whey protein-bound iron will be given over the course of six months to allergic and
      non-allergic women. Changes in 1) the clinical reactivity 2) the iron status and 3) the
      microflora will be assessed. The study will be the first systematic approach in humans to
      assess the contribution of iron deficiency to allergy and will be pivotal in supporting the
      implementation of prophylactic and therapeutic recommendations.
    

Intervention name(s): ImmunoBon; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The dietary agent contains vitamin A, Zn, chelated iron and whey proteins.; the dietary agent does not contain vitamin A, Zn, chelated iron and whey proteins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Allergy; iron-deficiency; birch; grass
Atorvastatin Three Year Pediatric Study
Condition: Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to characterize three year descriptive growth and development
      (ie, height, weight, body mass index, Tanner Stage) and efficacy of cholesterol reduction in
      pediatric subjects with Heterozygous Familial Hypercholesterolemia receiving atorvastatin
      treatment.
    


Intervention name(s): atorvastatin
Intervention type(s): Drug
Intervention description(s): Atorvastatin tablets or chewable tablets, 5, 10, 20, 40 mg strengths, once daily, for three years (an 80 mg maximum daily dose is delivered by taking two 40 mg strengths, once daily)
Intervention MeSH terms: Atorvastatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatric heterozygous familial hypercholesterolemia
Surgical or Conservative Treatment of Sportsman Hernia
Condition: Groin Pain
MeSH terms: Hernia
Study type: Interventional

Summary: 
      Five to ten percent of athletes and physical active adults are suffering chronic groin pain.
      The most common diagnoses are adductor tendinitis, sportsman hernia and osteitis pubis.
      Sportsman hernia is not a real hernia in the groin, but overuse injury of the groin muscles
      and tendons. No evidence-based treatment of this disabling condition has been found so far.
      Experimental surgical treatments are based on various hernioplasties. Laparoscopic
      extraperitoneal hernioplasty (TEP) is a mini-invasive and effective method to heal sportsman
      hernia in non-randomized cohorts.
    

Detailed description: 
      This prospective randomized study investigates the effect of active conservative treatment
      (rest, physical treatment, corticosteroid injections, anti-inflammatory analgesics) versus
      surgery (laparoscopic TEP) on the healing of sportsman hernia. Diagnosis of sportsman hernia
      is always based on careful clinical examination and magnetic resonance imaging. 25 patients
      with sportsman hernia are randomized into conservative treatment and 25 patients in surgery.
      The duration of follow-up is 1 year. The main end-point of treatments is disappearing of
      chronic groin pain (visual analogue scale, entering to sports).
    

Intervention name(s): laparoscopic hernioplasty (TEP)
Intervention type(s): Procedure
Intervention description(s): Insertion of polypropylene mesh behind pubic bone
Other intervention name(s): laparoscopic surgery in groin pain; surgical treatment of sportsman hernia
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: groin pain; sportsman hernia; osteitis pubis; laparoscopic surgery
Immunogenicity and Safety Study of the 13-valent Pneumococcal Polysaccharide Conjugate Vaccine in 2-71 Months Old Healthy Infants and Toddlers (the Youngest Could be 6 Weeks Old)
Condition: Diseases Caused by Streptococcus Pneumoniae Serotypes
MeSH terms: Pneumonia, Pneumococcal
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate and valuate the immunogenicity and safety of the
      13-valent pneumococcal polysaccharide conjugate vaccine in 2-71 months old healthy infants
      and toddlers (the youngest could be 6 weeks old)
    


Intervention name(s): 7-valent pneumococcal conjugate vaccine; 13-valent pneumococcal polysaccharide conjugate vaccine
Intervention type(s): Biological; Biological
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Parent Specific Depression Education and Motivation
Condition: Depressive Symptoms
MeSH terms: Depression
Study type: Interventional

Summary: 
      This project is an investigator-initiated, randomized-controlled trial of the effectiveness
      of written and verbal parent-specific depression education and motivational advice in
      increasing participants self-disclosed intention to seek follow-up care for possible
      depression symptoms. The control condition is written and verbal general depression education
      and advice. Hypothesis: the office-based experimental intervention of written and verbal
      parent-specific depression and emotional health education and motivational advice increases
      intention to seek follow-up services for emotional health or depression, when compared to
      written and verbal general depression education and advice.
    

Detailed description: 
      Maternal depression is a common problem, debilitating for mothers and affecting parenting
      practices with negative effects on the behavior, development, and physical health of
      children. The value of identifying and treating maternal depression for child development and
      well-being is well documented. Unfortunately, there are multiple barriers to the recognition
      and treatment of maternal depression. This is particularly problematic in younger women, as
      they are less often seen for health care. The overall objective of this project is to test
      whether the uptake of follow-up recommendations for potential depression by mothers
      identified by screening in clinical settings is improved by parent-specific targetting of
      depression education and motivational advice.
    

Intervention name(s): Parent-Specific Depression Education and Motivation; General Depression Education-Motivation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Parent-specific written and verbal depression messages garnered from previous research were consolidated into a pamphlet and script, respectively. These are dispensed after randomization in the pediatric office. At two days, mothers in the experimental group receive a motivational telephone call.; General depression education messages were compiled and are delivered verbally (scripted) and written (JAMA Depression Patient Page) after randomization in the pediatric office. At 2 days, mothers in the comparison group receive an attention control telephone call.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: depression; treatment; motivation to seek follow up