bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Wheat Sprouts Supplements on the Key Health Indicators of the Patients With Breast Cancer After Chemotherapy
Condition: Nutritional Status, Immune Function, Quality of Life Uring the Progress of Chemotherapy
Study type: Observational

Summary: 
      To explore the effects of wheat sprouts supplements on the key health indicators of the
      patients with breast cancer after chemotherapy, Maiji tablets, a wheat sprouts supplement,
      were used to treat 26 patients during the progress of chemotherapy and nutritional status,
      immune function, quality of life were measured and evaluated. Through data analysis, we found
      that Maiji tablets may improve the symptoms of appetite loss, nausea and vomiting, and
      fatigue in patients with breast cancer during chemotherapy. Meanwhile it may help patients
      maintain weight, keep appetite and improve the food intake.
    


Intervention name(s): wheat sprouts supplement
Intervention type(s): Dietary Supplement
Intervention description(s): Maiji tablets, a wheat sprouts supplement, were used to treat 26 patients during the progress of chemotherapy
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients diagnosed with breast cancer, receiving chemotherapy for the first time
Cerebral Responses to Insulin Induced Hypoglycemia
Condition: Type 1 Diabetes; Healthy; Hypoglycemia Unawareness
MeSH terms: Unconsciousness; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional

Summary: 
      This research study is designed to investigate the effect of hypoglycemia (low blood sugar)
      on blood flow to and biochemistry in the brain.
    

Detailed description: 
      The purpose of this study is to better understand the effect of low blood sugar
      (hypoglycemia) on blood flow and biochemistry in the brain. Hypoglycemia is a serious
      complication of diabetes treatments. It has been previously observed that hypoglycemia causes
      an increase in blood flow to certain parts of the brain, but it has been difficult to
      determine which parts of the brain specifically have an increase in blood flow. With new
      technology, it is now possible to determine the rate of blood flow in very small parts of the
      brain. The investigator expects that people with type 1 diabetes and hypoglycemia
      unawareness, poorly controlled diabetes, and normal subjects will have different rates of
      blood flow to different parts of the brain in response to hypoglycemia. Having a greater
      understanding of how the brain adapts to hypoglycemia may help us develop better ways to
      treat diabetes more safely.
    

Intervention name(s): hypoglycemia (low blood sugar) in MRI
Intervention type(s): Other
Intervention description(s): hypoglycemia (low blood sugar) in MRI
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: type 1 diabetes; hypoglycemia unawareness; healthy control
An Analysis of the Improvement and Quality of Life Trends for UK/ROI Patients Treated With Cosentyx (Secukinumab) in a Retrospective Analysis of the BADBIR Data Source
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Observational

Summary: 
      This was a retrospective, observational study of psoriasis patients treated with secukinumab,
      using secondary data from BADBIR. BADBIR is a UK/ROI pharmacovigilance registry that was
      initiated in 2007 to monitor the long-term safety of biologic drugs used to treat psoriasis.
      The study used longitudinal data within the registry to track the trends relating to the
      disease. For the analysis of improvement and patient reported QoL, patients with a minimum of
      one follow-up visit were included. The index date was defined as the date of initiation of
      secukinumab treatment, and follow-up visits were at 6-, 12-, 18-, & 24-months post-index.
    

Detailed description: 
      The BADBIR data was current up until the 31st August 2019 for this analysis.

      Study period: From 1st July 2015, as secukinumab was included in BADBIR in January 2016 and
      patients backdated 6 months, to 31st August 2019.

      Identification period: From 1st July 2015 to 31st August 2019 was used to identify applicable
      patients for analysis.

      Index date: Initiation of secukinumab treatment within the BADBIR database.
    

Intervention name(s): Secukinumab
Intervention type(s): Other
Intervention description(s): Included patients treated with Cosentyx (Secukinumab) in a retrospective analysis of the BADBIR data source
Other intervention name(s): Cosentyx
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The BADBIR registry included patients treated for psoriasis using biologics, conventional
        systemic therapies, or small molecule immunomodulators
      
Keywords: Cosentyx,; Secukinumab,; Quality of Life,; UK
A Study to Assess the Efficacy and Safety of CBP-201 in Adult Subjects With Moderate to Severe Atopic Dermatitis
Condition: Moderate-to-severe Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of
      CBP-201 in adult subjects with moderate to severe atopic dermatitis.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, dose regimen finding study to assess
      the efficacy, safety, and steady-state PK profile of CBP-201 administered to eligible adult
      subjects with moderate to severe atopic dermatitis compared to placebo. CBP-201 is
      administered as a subcutaneous (SC) injection. The study is divided into a treatment period
      of 16 weeks and a follow-up period of 8 weeks.
    

Intervention name(s): CBP-201; placebo
Intervention type(s): Drug; Drug
Intervention description(s): CBP-201 subcutaneous(SC) injection.; subcutaneous(SC) injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Echocardiographic Study of the Haemodynamic Effects of Remifentanil With and Without Glycopyrrolate in Healthy Children
Condition: Urological Surgery
Study type: Interventional
Phase: Phase 2

Summary: 
      Study to investigate the influence of remifentanil and glycopyrrolate on cardiac index and
      blood pressure in children.To differentiate between contractility and the effect of the
      circulating volume, some of the subjects will receive additional fluid.This will be evaluated
      using two transthoracic echocardiac exams within the first 30 min of anesthesia.
    


Intervention name(s): Administration of remifentanil and glycopyrrolate
Intervention type(s): Drug
Intervention description(s): 2 mg, intravenius use
Intervention MeSH terms: Glycopyrrolate; Remifentanil
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Message Priming and Enrollment in, and Response to, a Smoking Cessation Program: A Pilot Study
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 4

Summary: 
      The proposed study has been designed to examine the effect of a message that primes genetic
      susceptibility on actual enrollment in a smoking cessation program, actual response to
      smoking cessation treatment, and potential moderators and mediators of this effect.
    

Detailed description: 
      Despite available behavioral and pharmacological interventions to treat nicotine dependence,
      most smokers do not utilize these interventions. As such, the vast majority of smokers do not
      capitalize on potentially effective nicotine dependence treatments. The way in which health
      risk information is presented may influence interest in a smoking cessation program. In a
      series of preliminary studies, individuals provided with messages that primed the role of
      genetic variation in susceptibility to addiction to smoking exhibited positive consequences
      on intentions to quit (Cappella, Lerman, Romantan, & Baruh, 2005). The proposed study has
      been designed to examine the effect of a message that primes genetic susceptibility on actual
      enrollment in a smoking cessation program, actual response to smoking cessation treatment,
      and potential moderators and mediators of this effect. The results of this pilot study may
      provide preliminary data for a larger trial and have implications for designing interventions
      to promote utilization of effective treatments for nicotine dependence among smokers.
    

Intervention name(s): Message Prime; Message Prime
Intervention type(s): Other; Other
Intervention description(s): Participants will be randomized to genetic prime messages or threat only message at the time of the intial telephone screen. Following phone screen, all eligibleparticipants will receive 13 weeks of Chantix with smoking cessation counseling.; Particpants will be randomized into 1 of 2 groups. 1 group will recieve a message detailing the negative helaht consequenes of smoking and the other group will receive this information along with information about the genetic incluences on smoking behavior.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: smoking cessation; nicotine dependence; message prime; recruitment
Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD5055 in Japanese and Chinese Healthy Volunteers..
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and
      tolerability of AZD5055 after single and multiple doses, orally administered in healthy
      Japanese and Chinese participants.
    

Detailed description: 
      The study will be conducted in 2 parts:

        1. Part 1 in single ascending dose (SAD)

        2. Multiple dose Eligible Japanese and Chinese participants will be randomized to receive
           oral dose of either AZD5055 or placebo.

      The study will comprise of:

        -  A Screening Period of maximum 28 days.

        -  A Treatment Period during which participants will be resident at the Clinical Unit from
           the day before investigational medicinal product (IMP) administration until at least 72
           hours after IMP administration.

        -  A Follow-up Visit within 7 ± 1 (for Part 1) and 15 ± 1 (for Part 2) days after the last
           IMP dose.

      For the SAD part of the study, each participant will be involved in the study for 5 to 6
      weeks.

      For the multiple dose part of the study, each participant will be involved in the study for 7
      to 8 weeks.
    

Intervention name(s): AZD5055; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): AZD5055 will be given orally to randomized participants as per the arm they are assigned.; Placebo will be given orally to randomized participants as per the arm they are assigned.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Single ascending dose (SAD)
Effect Of Treatment With Oral Zolpidem On Polysomnography And Actigraphy Measures In Healthy Volunteers
Condition: Methodology Study
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the feasibility of conducting sleep studies in a clinical research
      unit environment. In addition, the sensitivity of polysomnography and mobile actigraphy
      technologies will be compared for evaluating sleep stages and sleep architecture.
    


Intervention name(s): placebo; zolpidem; zolpidem
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single oral dose placebo; single oral dose, 5 mg zolpidem; single oral dose, 10 mg zolpidem
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: mobile actigraphy inpatient polysomnography actigraphy ambien
Pharmacokinetic Study of Daptomycin in Healthy Chinese Subjects Living in China
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to characterise the pharmacokinetics and dose
      proportionality of daptomycin after single and multiple (once daily) 4mg/kg and 6 mg/kg doses
      of daptomycin in healthy Chinese volunteers.
    


Intervention name(s): Daptomycin
Intervention type(s): Drug
Intervention description(s): 4mg/kg and 6 mg/kg dissolved in 0.9% sodium chloride for injection, administered intravenously over 30 minutes.
Other intervention name(s): Cubicin
Intervention MeSH terms: Daptomycin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cubicin; PK; China Registration; Pharmacokinetics
A Phase III Study to Assess the Lot-to-lot Consistency of GSK's Investigational RSV Maternal Vaccine and the Immune Response and Safety of RSV Maternal Vaccine When Given Alone or Co-administered With GSK's Influenza D-QIV Vaccine in Healthy Non-pregnant Women.
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Influenza, Human; Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the clinical lot-to-lot consistency of the
      respiratory syncytial virus (RSV) maternal (RSV MAT) vaccine administered to healthy
      non-pregnant women 18-49 years of age (YOA). In addition, this study will evaluate
      immunogenicity, safety and reactogenicity from co-administration of RSV MAT vaccine and GSK's
      quadrivalent seasonal influenza (Flu D-QIV) vaccine.
    


Intervention name(s): RSVPreF3(120 μg); Flu Quadrivalent influenza vaccine (15 μg HA); Placebo
Intervention type(s): Combination Product; Combination Product; Combination Product
Intervention description(s): A single dose of RSVPreF3(120 μg) combined with Sodium Chloride (NaCl) was administrated intramuscular (IM). There were used 3 different lots of RSVPreF3(120 μg), one for each individual group (RSV lot1 Group, RSV lot2 Group and RSV lot3 Group) considered under RSV pooled Group.; A single dose of Flu Quadrivalent influenza (15 μg HA) vaccine was administrated intramuscular (IM).; One dose of placebo, administered intramuscularly in the deltoid region of the right arm, at Day 1.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Respiratory Syncytial Virus Maternal vaccine; Flu Quadrivalent influenza vaccine; Lot-to-lot consistency; Immunogenicity; Safety; Reactogenicity
A Study for the Treatment of Mania Associated With Bipolar I Disorder in Children and Adolescents
Condition: Bipolar I Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the long-term safety profile of the Investigational
      Medication Depakote ER in the treatment of Bipolar I Disorder, manic or mixed episode, in
      children and adolescents ages 10-17.
    


Intervention name(s): Divalproex Sodium (Depakote ER)
Intervention type(s): Drug
Intervention MeSH terms: Valproic Acid
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bipolar I Disorder; Depakote
Comparison of Three Protocols for Tight Glycemic Control in Cardiac Surgery Patients
Condition: Hyperglycemia
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      A randomized trial to compare three insulin-titration protocols for tight glycemic control in
      surgical ICU: an absolute glucose (Matias) protocol, a relative glucose change (Bath)
      protocol, and an enhanced model predictive control algorithm (eMPC)
    

Detailed description: 
      120 consecutive post-cardiac surgery patients randomized to the three protocols with a target
      glycemia range from 4.4 to 6.1 mmol/l. Intravenous insulin was administered continuously or
      in combination with insulin boluses (Matias protocol). Blood glucose was measured in 1-4 hour
      intervals as requested by protocols.
    

Intervention name(s): insulin
Intervention type(s): Drug
Intervention description(s): Insulin was was administered according to each protocol rules/suggestions into a central venous line as a continuous infusion (Bath and eMPC protocols) or as a combination of a continuous infusion and boluses (Matias protocol). A standard concentration of 50 IU of insulin in 50 ml of 0.9% NaCl was used. In all patients, infusion of 10% glucose solution was initiated upon admission to ICU with glucose dose of 2.5 g/kg of ideal body weight (height in centimetres minus 100) per hour and lasted for 18 hours, when normal oral food intake was started. In ventilated patients, the glucose infusion lasted for 48 hours, and then standard enteral nutrition was initiated.
Other intervention name(s): Actrapid HM, Novo Nordisk, Baegsvard, Denmark
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tight glycemia control; cardiac surgery patients
Tobramycin Inhalation Solution Administered by eFlow Rapid Nebulizer: Scintigraphy Study
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study assesses the aerosol delivery characteristics (measured by in vivo lung
      deposition, nebulization time, serum tobramycin concentrations, and pharmacokinetic
      parameters) and safety of tobramycin inhalation solution administered for inhalation by PARI
      eFlow rapid electronic nebulizer (no compressor) vs. PARI LC PLUS Jet Nebulizer (with
      compressor) in healthy subjects and in subjects with cystic fibrosis.
    


Intervention name(s): Tobramycin
Intervention type(s): Drug
Intervention MeSH terms: Tobramycin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cystic fibrosis, tobramycin, PARI eFlow, PARI LC Plus, nebulizer, pharmacoscintigraphy
Luteal Phase Supplementation With Recombinant LH After GnRh Agonist Oocytes Triggering in Women at Risk of OHSS
Condition: Ovarian Hyperstimulation Syndrome
MeSH terms: Ovarian Hyperstimulation Syndrome
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study is to prove that luteal phase supplementation with recombinant LH
      can solve the luteal phase deficiency after Gnrh agonist oocytes triggering in women at risk
      of OHSS
    

Detailed description: 
      The investigators enrolled patients, undergoing controlled ovarian stimulation for an
      IVF/ICSI cycles, who on the day of oocytes triggering were at risk of OHSS.

      These patients had an estradiol > 4000 pg/ml and more than 24 follicles with a diameter
      greater than 12 mm.

      The investigators used 0,2 mg of triptorelin for the oocytes triggering and supplemented the
      luteal phase with recombinant LH at a dose of 75 UI twice/day for 10 days and vaginal gel
      progesterone and oral oestradiol for 14 days The investigators measured bhCG at 14 days from
      the pick up. In case of positive bhCG we have defined the IVF/ICSI outcome: Pregnancy Rate
      and Implantation Rate.
    

Intervention name(s): recombinant LH
Intervention type(s): Drug
Intervention description(s): recombinant LH twice/day for 10 days from pick up
Other intervention name(s): Luveris rLH by Merck Serono
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Infertile patients undergoing controlled ovarian hyperstimulation
      
Keywords: OHSS; Oocytes triggering; GnRh agonist triggering; Luteal phase supplementation; recombinant LH
A Study of Caspofungin (MK-0991) in Japanese Children and Adolescents With Documented Candida or Aspergillus Infections (MK-0991-074)
Condition: Candidiasis, Esophageal; Candidiasis, Invasive; Aspergillosis
MeSH terms: Candidiasis; Aspergillosis; Candidiasis, Invasive
Study type: Interventional
Phase: Phase 2

Summary: 
      The study estimates the safety, efficacy, and pharmacokinetics of caspofungin (MK-0991) in
      Japanese children and adolescents with documented Candida or Aspergillus infections.
    


Intervention name(s): Caspofungin
Intervention type(s): Drug
Other intervention name(s): MK-0991; CANCIDAS®
Intervention MeSH terms: Caspofungin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Tools for Lasting Lifestyle Changes
Condition: Cardiovascular Diseases; Lifestyle Risk Reduction
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Pilot and feasibility study; a complex intervention focusing on lifestyle change to increase
      physical activity and reduce cardiovascular disease (CVD) risk among high risk individuals.
    

Detailed description: 
      Interdisciplinary, mixed-method, prospective and single-arm exploratory study aimed to
      explore study feasibility, responsiveness, participants adherence and adverse events among
      the participants before deciding to proceed to full-scale evaluation.

      Enrollment of max. 20 obese people (BMI>30) with sedentary lifestyle and increased CVD-risk
      (NORRISK2)..

      Participants general health status including cardiopulmonary fitness will be assessed both
      before and after the intervention (blood pressure, ECG, spirometry, treadmill tests VO2max,
      blood tests, body composition by Dual-energy X-ray absorptiometry (DEXA) measurements)
      Participants´ functional capacity assessed by several range of motion tests. Participants
      nutritional and psychological status assessed by validated questionnaires.

      Several blood-tests and ECG will be recorded at three months.

      Daily activity level during and six months after the intervention period monitored by Polar
      M430 pulse watch.

      The participants will be interviewed with focus on their prior health, activity habits and
      intervention experiences at three months and six months after end of the intervention. Two
      focus-group interviews at end of intervention.
    

Intervention name(s): Lifestyle counselling and exercise
Intervention type(s): Behavioral
Intervention description(s): The program consists of:
Instructor-led training twice a week,
One individual nutritionist counselling session of followed by three group based two-hour nutritionist counselling focusing on practical food purchase and preparation and
Three two-hour psychologist-led group counselling sessions based on implementation intentions theory and practical help to make if-then plans focusing on changing food and activity habits.
Intervention model: Single Group Assignment
Intervention model description: Feasibility study
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Primary intervention