bioihbjkbjnl/mcl2 huggingface dataset:
Phase IV Trial to Collect Safety Data and Sera in Healthy Children Given Fluzone Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      To provide serum to the Food and Drug Administration (FDA) for use by FDA, the Centers for
      Disease Control and Prevention (CDC), and the World Health Organization (WHO) for
      characterization of circulating influenza strains.

      Observational Objectives:

      To describe the safety of the 2005-2006 pediatric formulation of Fluzone vaccine, given in
      the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to <
      36 months.

      To describe the immunogenicity of the 2005-2006 pediatric formulation of Fluzone vaccine,
      administered in a two-dose schedule in accordance with the Package Insert, in children aged ≥
      6 months to < 36 months.
    


Intervention name(s): Influenza Virus Vaccine (Fluzone®); Influenza Virus Vaccine (Fluzone®)
Intervention type(s): Biological; Biological
Intervention description(s): 0.25 mL, Intramuscular (Day 0 and Day 28); 0.25 mL, Intramuscular (Day 0)
Other intervention name(s): Fluzone®; Fluzone®
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Fluzone®; Influenza Virus Vaccine
Mederma to Reduce Appearance of Post Surgical Scars
Condition: Scars
MeSH terms: Cicatrix
Study type: Interventional

Summary: 
      This is a single-center, 20-subject, investigator-blinded study to evaluate the effect of
      Mederma N&I to Mederma Ultra Gel on the appearance of post-surgical scars.
    

Detailed description: 
      This is a 10-week research study designed to compare the effect of two gels on the appearance
      of post surgical scarring of the chest and/or back. The subject will be asked to identify two
      symmetrical skin growths that they would like to have removed: one on the left chest and/or
      back and one on the right chest and/or back. Additionally, the subject will identify a third
      skin growth that they would like removed which is a reasonable distance from the two
      symmetrical skin growths and will be located either on the back or the chest.

      Inclusion Criteria:

        -  Healthy male and non pregnant female subjects ≥18 years of age

        -  have seborrheic keratoses on the right and left chest and/or back

      Exclusion Criteria:

      -Subjects with known allergies or sensitivities to ingredients contained in the test product
      including onion extract and Lidocaine.
    

Intervention name(s): Mederma N&I; Mederma Ultra Gel
Intervention type(s): Other; Other
Intervention description(s): Topical gel applied three times a day for eight weeks.; Topical gel applied once daily for eight weeks.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Keywords: surgical; scars; Mederma
Efficacy and Safety Study With Diltiazem Hydrochloride Cream to Treat Anal Fissures
Condition: Chronic Anal Fissures
MeSH terms: Fissure in Ano
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if the study drug, VEN307 (diltiazem hydrochloride
      cream) is safe and to see if it will help with treatment of pain associated with anal
      fissures.
    

Detailed description: 
      Primary Objective:

      To evaluate the efficacy of diltiazem hydrochloride cream on reduction of worst anal fissure
      (AF)-related pain associated with or following defecation when administered three times a day
      (TID) for 28 days.
    

Intervention name(s): VEN 307; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): VEN307 applied three times a day, in and around the anus, for 28 days.; Placebo cream applied three times a day, in and around the anus, for 28 days.
Other intervention name(s): diltiazem hydrochloride 2% cream; Placebo cream
Intervention MeSH terms: Diltiazem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Anal; Fissure; Pain
A Study of LY2405319 in Participants With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study was to evaluate the safety and tolerability of LY2405319. It
      was given as a daily injection under the skin to participants with type 2 diabetes mellitus
      (T2DM) for 28 days. This study determined how long the drug stays in the body and how it
      affects blood sugar levels. After screening, the study lasted about 2 months for each
      participant. Participants continued their prestudy regimen of diet and exercise alone or in
      combination with metformin.
    


Intervention name(s): LY2405319; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      28-Day double-blinded efficacy and safety trial of SPX-101 Inhalation Solution in adult
      subjects with cystic fibrosis.
    


Intervention name(s): Placebo Inhalation Solution; SPX-101
Intervention type(s): Drug; Drug
Intervention description(s): Normal Saline Inhalation Solution; SPX-101 Inhalation Solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
UARK 2010-35, A Study of Expanded Natural Killer Cell Therapy for Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the therapeutic efficacy of the exp-NK cell therapy
      in research participants with relapsed high risk MM [defined as gene expression profile (GEP)
      70 gene score ≥0.66 and/or metaphase chromosomal abnormalities and/or high LDH ≥ 360U/L] by
      establishing the (near) complete response rate. Response rate will be compared to case
      matched historical controls (patients who relapsed on Total Therapy 2 or 3 with high-risk MM
      defined as above). Disease-free survival and overall survival will be captured but are not
      primary or secondary endpoints.
    

Detailed description: 
      The use of auto-exp-NK cells in this protocol makes therapy available to all refractory high
      risk MM patients, 2/3 of whom would otherwise not have a suitable haploidentical donor. We
      have shown that NK cells can be expanded both from newly diagnosed high risk MM patients and
      from refractory, previously heavily treated patients, the very individuals in need of novel
      therapies such as exp-NK cell infusions. Furthermore, we observed that exp-NK cells have the
      ability to kill auto-MM cells in vitro compared to no killing with resting auto-NK cells.
      This may be due to the elevated activation state of exp-NK cells, which allows them to
      overcome otherwise dominant inhibitory signaling. The incorporation of the proteasome
      inhibitor bortezomib, which down regulates the principal NK cell inhibitory ligands on MM
      cells should further increase the efficacy of auto-exp-NK cells. Because there is no risk for
      GvHD, CD3+ T cell depletion will not be necessary for auto-exp-NK cell products.
    

Intervention name(s): Bortezomib
Intervention type(s): Drug
Intervention description(s): bortezomib to be given days -9, -6, and -2 at 1.0mg/m2, i.v.
Other intervention name(s): Velcade
Intervention MeSH terms: Bortezomib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Multiple Myeloma
24-hour Efficacy of AR-12286
Condition: Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      An open-label, non-comparative, pilot evaluation of the 24-hour ocular hypotensive efficacy
      of AR-12286 in patients with open-angle glaucoma or ocular hypertension
    


Intervention name(s): AR-12286 0.5% Ophthalmic Solution
Intervention type(s): Drug
Intervention description(s): Ophthalmic Solution
Intervention MeSH terms: Ophthalmic Solutions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intraocular pressure
Comparison of CRP Levels, Neutrophil Count, and Clinical Outcomes of Low Dose Ketamine Between at Anesthesia Induction and at the End of Surgery in Patients Undergo Elective Laparotomy
Condition: General Anesthesia; Laparotomy; Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The effects of anesthesia and surgery can lead to stress responses that result in hormonal
      and metabolic changes in the body. The immune system and the nervous system communicate both
      ways, and it was found that nociception and proinflammatory cytokines play a joint regulatory
      role, i.e., increased production of proinflammatory cytokines can worsen the pain. Major
      surgery can trigger the release of cytokines such as IL-1, IL-6, and TNF-α.
    

Detailed description: 
      The effects of anesthesia and surgery can lead to stress responses that result in hormonal
      and metabolic changes in the body. The immune system and the nervous system communicate both
      ways, and it was found that nociception and proinflammatory cytokines play a joint regulatory
      role, i.e., increased production of proinflammatory cytokines can worsen the pain. Major
      surgery can trigger the release of cytokines such as IL-1, IL-6, and TNF-α.

      The acute analgesic effect of ketamine is generally believed to be mediated through the
      blockade of the phencyclidine binding site of the N-methyl-d-aspartate (NMDA) receptor of
      nociceptive neurons. Ketamine can reduce the inflammatory response marked by a decrease in
      CRP levels to surgical trauma and can prevent secondary damage to tissues/organs that were
      not initially affected by surgery by reducing inflammation. This also reduces postoperative
      pain and analgesics.
    

Intervention name(s): Ketamine 0.3 mg/kg at end-of-surgery; Ketamine 0.3 mg/kg at anesthesia induction
Intervention type(s): Drug; Drug
Intervention description(s): Ketamine 0.3 mg/kg at end-of-surgery (intravenously); Ketamine 0.3 mg/kg at anesthesia induction (intravenously)
Other intervention name(s): Group E; Group I
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a double-blind, randomized control trial. It provides a controlled care comparison between low-dose ketamine given at anesthesia induction and at the end-of-surgery.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: stress response; infammation; general anesthesia
Outcomes of Colonoscopy With Non-anesthesiologist Administered Propofol
Condition: Colo-rectal Cancer; Colon Adenoma; ADR
MeSH terms: Adenoma
Study type: Interventional

Summary: 
      The Efficacy and safety of Non-anesthesiologist administered propofol (NAAP) for
      gastrointestinal endoscopy have been widely documented although there is not information
      which has evaluated the outcomes of colonoscopy it self when the endoscopist has to fulfill
      the additional task of supervising the sedation.

      Objective: To determine the equivalence of adenoma detection rate (ADR) in colorectal cancer
      (CRC) screening colonoscopies performed with NAAP and performed with monitored anesthesia
      care (MAC).

      Method: Single blind non-randomized controlled equivalence trial. Patients: Adults between 50
      - 69 years old from National CRC screening program (CRCSP). Intervention: The patients are
      blindly assigned to undergo either colonoscopy with NAAP or MAC according to the arrival of
      fecal occult blood test, patient's suitability for colonoscopy date and availability of
      places at endoscopy schedule (with NAAP or MAC).
    


Intervention name(s): Sedation directed by an endoscopist; Sedation directed by an anesthesiologist
Intervention type(s): Procedure; Procedure
Intervention description(s): The nurse begins with fentanyl infusion in bolus: 75 μg (1.5 ml) and initial propofol dose (10mg/ml) in bolus of 0.5 - 2.5 mg/Kg followed by a maintenance dose of 20 - 60ml/h through Target-controlled infusion (TCI) pump. In this way, we get a target level sedation between 1 - 3, according to Observer's Assessment of Alertness/Sedation Scale (OAAS).
The role of the nurse, directed by an endoscopist, it is exclusively the administration of intravenous drugs and the patient monitorship throughout the procedure.; The choice of the drugs and the target level sedation are directed by an anesthesiologist
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: ADR with Non-Anesthesiologist administered propofol (NAAP)
A Study of the Safety, Tolerance and Assessment of HE3286 on Insulin Sensitivity and Hepatic Glucose Production
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study are to evaluate the safety and tolerance of 20 mg (10 mg BID) of
      HE3286 when administered orally over 28 days to obese insulin-resistant adult subjects and,
      to assess the activity of HE3286 on insulin sensitivity and hepatic glucose production in
      obese insulin-resistant adult subjects.
    

Detailed description: 
      Hollis-Eden Pharmaceuticals, Inc. is developing a new class of therapeutics for the treatment
      of Type 2 diabetes mellitus (T2DM). The investigational drug, HE3286, is a synthetic analog
      of a naturally occurring hormone with a potentially new mechanism of action that may improve
      the current therapeutic options available to a T2DM patient.

      The glucose clamp is the gold standard for measurement of insulin sensitivity. Given the
      observed activity of HE3286 in reducing insulin resistance in both impaired glucose
      intolerant subjects and type 2 diabetic patients, it is necessary to evaluate the
      physiological site of action (i.e. liver vs. skeletal muscle) of HE3286 in order to further
      understand the mechanism of action and to design future clinical trials.
    

Intervention name(s): HE3286
Intervention type(s): Drug
Intervention description(s): HE3286 20 mg (10 mg BID) for 28 days
Other intervention name(s): TRIOLEX
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: phase I; safety; tolerance; insulin resistance; obese
Effect of GnRH Antagonist vs Agonist Long on IVF Outcome, Peak Estradiol Level,and Duration of Stimulation
Condition: Fertility
Study type: Interventional

Summary: 
      The purpose of this study is to determine if utilizing GnRH antagonists versus agonist long
      protocol during controlled ovarian stimulation (COH) with human-derived gonadotropins for
      assisted reproduction affects IVF outcome, peak estradiol level, and duration of stimulation.
    

Detailed description: 
      No detailed description
    

Intervention name(s): Bravelle and Menopur; Agonist; Antagonist
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Bravelle and Menopur are used for controlled ovarian stimulation (COH); Agonist (Lupron) is used to suppress endogenous pituitary LH for the premature LH surges.; Ganirelix acetate or cetrorelix acetate Agonist is used to suppress endogenous pituitary LH for the premature LH surges.
Other intervention name(s): Leuprolide Acetate; Lupron; ganirelix acetate; cetrorelix acetate
Intervention MeSH terms: Leuprolide; Cetrorelix; Menotropins; Ganirelix
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Safety and Efficacy of Kalifilcon A Daily Disposable Contact Lens
Condition: Contact Lens Wear
Study type: Interventional

Summary: 
      This study is to evaluate the safety and efficacy of a new silicone hydrogel daily disposable
      contact lens, kalifilcon A compared to the Bausch + Lomb Biotrue ONE day® daily disposable
      contact lens when worn by current soft contact lens wearers on a daily disposable wear basis.
    

Detailed description: 
      Approximately 247 participants (494 eyes) will be enrolled in at approximately 20
      investigative sites in the United States (US). A minimum of 20% of the randomized
      participants will be of Japanese descent (for example, both maternal and paternal
      grandparents born in Japan).
    

Intervention name(s): Kalifilcon A Daily Disposable Contact Lenses; Biotrue ONEday Daily Disposable Contact Lenses
Intervention type(s): Device; Device
Intervention description(s): Contact lens; Contact lens
Other intervention name(s): Bausch + Lomb Biotrue ONEday® Daily Contact Lens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Disposable Contact Lenses; Soft Contact Lens; Soft Contact Lenses
Clinical Verification of Peptide Biomarkers for Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Although diabetes has been controlled since insulin became available, it is still considered
      incurable and poses serious threats to human health. Reports have suggested that the
      hyperglycemic condition of patients with diabetes mellitus may be greatly alleviated or even
      reversed if it could be controlled at an early stage of diabetes. Thus, early detection and
      diagnosis of diabetes and prediabetes are become increasingly important in the treatment and
      prevention of diabetes. Diabetes mellitus is currently diagnosed by recurrent or persistent
      hyperglycemia. In an effort to identify novel biomarkers for diabetes, research has shown
      that neither plasma glucose nor glycated hemoglobin (HbA1c) levels are unable to be used in
      the early detection of diabetes. In this work, the investigators have found 8 biomarker
      candidates by developing a standard-free, label-free MS-based proteomics method based on
      standard protein (human serum albumin, the highest abundance protein in human plasma) model
      in vitro. Then, the investigators wanted to verify these biomarker candidates by clinical
      plasma samples to see if there is significant quantitative difference between normal people
      and diabetes patients.
    

Detailed description: 
      The procedure of clinical study was:

        1. to get plasma samples from hospital;

        2. digestion of plasma protein-mixture by trypsin;

        3. run mass spectrometry and monitor the amount of target HSA-peptides.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        university hospital, plasma samples of physical examination, faculties and staff of a
        certain university
      
Keywords: Type 2 Diabetes Mellitus; peptide biomarker; early diagnosis; label free
Respiratory Quotient and Food Liking, Food Wanting and Food Consumption
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to observe the influence of carbohydrate-to-fat balance on
      liking, wanting and food consumption in humans.

      16 normal-weight men (age: 23 ± 3 y)had completed a randomized 4-condition crossover study.
      The sessions differed by the composition of the breakfast which was rich in carbohydrates
      (HCB), low in carbohydrates (LCB), rich in fat (HFB) and low in fat (LFB). The HCB and HFB
      contained 2072 kJ, while the LCB and LFB contained 565 kJ. Two hours and 20 min later, energy
      expenditure (EE) and respiratory quotient (RQ) were measured before olfactory liking for 4
      foods items and then ad libitum energy intake (EI) during a snack (sweet and fatty toast)
      were evaluated.
    

Detailed description: 
      In accordance with the carbohydrate-based models of feeding, one may expect that food choices
      as well as "liking" and "wanting" (the two components of the reward system) could be
      influenced by glycogen stores and the carbohydrate-to-fat balance. More precisely, one may
      expect that a high fat oxidation rate could increase liking and wanting carbohydrates to
      replenish glycogen stores and conversely, that a high carbohydrate oxidation rate could
      produce the reverse. In order to validate this hypothesis, the present study has been
      conducted to investigate in humans the influence of the carbohydrate-to-fat oxidation ratio
      on carbohydrate-to-fat selection and the food reward system.
    

Intervention name(s): food preloads
Intervention type(s): Behavioral
Intervention description(s): Subjects will eat in the morning during breakfast 300g cottage cheese (627kJ - 147kcal; 13.2g carbohydrate, 0.3g fat, 23g protein) plus, according to the situations, either: 90g sucrose, HCB); 6g aspartame; 40g vegetable oil; 40g paraffin oil. Therefore two breakfast will have the same energy content (2072kJ - 495kcal), as did the other two(565 kJ - 135kcal).
Other intervention name(s): food intake; metabolism
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: energy intake; energy expenditure; macronutrient selection