bioihbjkbjnl/mcl2 huggingface dataset:
Fluid Volume-hypotension Association in Cesarean Under Neuraxial Anesthesia
Condition: Cesarean Section
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      Hypotension resulted from neuraxial block is a common problem, of which is a special issue in
      patients undergoing Cesarean section. A large number of studies and clinical guidelines
      suggest that fluid loading, pre- or co-anesthesia, is a promising manner in preventing
      hypotension. However, it is still a controversy because the fact of a relatively increased
      blood volume in parturients. In addition, although it is effective of fluid management, it's
      precise relationship between fluid (crystalloid or colloid) volume and the proportion of
      hypotension in Cesarean patients under neuraxial anesthesia is still unknown. The
      investigators designed this trial to clarify the accurate relationship between fluid volume
      in an escalated manner and the occurrence of hypotension analyzed with a non-linear
      regression, and wanted to present the 50% effective volume (EV50) of fluid including
      crystalloid and colloid in preventing hypotension in patients undergoing Cesarean section.
    


Intervention name(s): Ringer's Lactate; Six percent hydroxyethyl starch
Intervention type(s): Drug; Drug
Intervention description(s): Ringer's Lactate 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 15 ml/kg is given to patients pre-, co- and post-neuraxial blocks; Six percent hydroxyethyl starch 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 15 ml/kg is given to patients pre-, co- and post-neuraxial blocks
Other intervention name(s): Lactated Ringer's solution; HES/HAES
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Epidural anesthesia; Spinal anesthesia; Combined spinal-epidural anesthesia; Fluid therapy; Crystalloid; Colloid
A Study of AK111 in Subjects With Moderate-to-severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase Ib clinical study of multiple dose escalation of AK111 in subjects with
      moderate-to-severe plaque psoriasis
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled phase Ib clinical study. This study
      aims to determine the safety, tolerance, pharmacokinetics(PK) and Pharmacodynamics (PD)
      characteristics, immunogenicity and preliminary clinical efficacy of multiple dose escalation
      administration of AK111 in subjects with moderate-to-severe plaque psoriasis..
    

Intervention name(s): AK111; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive one of four escalated doses of AK111 (75mg/150mg/300mg/450mg) injection subcutaneously.; Subjects will receive corresponding dose of placebo injection subcutaneously.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Comparison of PYY, Ghrelin, GLP1, Glucose Level, Level of Satiety, and Ad Libitum Intake in Obese and Non-Obese Patients After Breakfast With Balanced Macronutrient Composition
Condition: PYY; Ghrelin; Appetite; Gut Hormones; Obesity; VAS of Satiety; VAS of Hunger; GLP - 1
Study type: Interventional

Summary: 
      Obesity can occur due to an imbalance of energy. This energy balance is greatly influenced by
      hunger and satiety. Obese person cannot resist hunger, while non obese can control hunger.
      Gut hormones, such as PYY and ghrelin, are associated with appetite and satiety control. This
      study's objective is to compare the effect of breakfast with balance composition on gut
      hormones, glucose and ad libitum intake four hours after breakfast between obese and non
      obese..

      The research methodology was used a clinical trial with 18 obese women and 22 non obese women
      participants. Subjects were given a balance breakfast (protein 12,4%, carbohydrate 68,2%, fat
      22,6%). Gut hormones (PYY, Ghrelin, GLP -1) level , Glucose level and satiety level were
      measured at 0, 15, 60, 120, and 180 minutes after breakfast. Ad libitum meal was given four
      hours after breakfast and measured after.
    


Intervention name(s): Diet with balance composition to know the effect of a meal to gut hormones in obese and non obese women
Intervention type(s): Behavioral
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Lipid Lowering in Patients With Statin Intolerance
Condition: Hyperlipidemia; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional

Summary: 
      This study will attempt to further validate a clinical treatment plan to lower LDL values
      using non-prescription supplements combined with a lifestyle change and education program
      which could represent an alternative approach to improve compliance in group of people who
      are unable to take traditional medication to lower cholesterol.
    

Detailed description: 
      Up to 70 participants will be randomized into 2 groups. Each shall have similar total and LDL
      cholesterol values obtained prior to the study. Study Group 1 will participate in the Change
      of Heart Program (an intensive program to make therapeutic lifestyle changes) and take a
      placebo pill. Study Group 2 will also participate in Change of Heart. Group 2 will be
      provided an over the counter supplement consisting of red rice yeast 2.4-3.6 gms day)

      Blood work consisting of a lipid panel, cardiac CRP, CPK, liver function panel and TSH will
      be obtained prior to study, and at 12 and 26 wks. Questionnaires will be administered
      regarding quality of life indexes, and ancillary symptom relief (i.e. degree of arthritis
      discomfort, generalized weakness) before, 12 and 26 weeks. After the Change of Heart program
      ends (12 weeks), participants will continue on study medication for a total of 6 months. A
      final questionnaire and final blood work will be obtained at 6 months, and at that point,
      medications can be discontinued.
    

Intervention name(s): red yeast rice; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 600 mg 3 caps bid; 3 caps bid
Intervention MeSH terms: Red yeast rice
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: statin intolerance; hyperlipidemia; lifestyle changes; red yeast rice
A Study of MabThera (Rituximab) in Patients With Advanced Non-Hodgkin's Lymphoma
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 3

Summary: 
      This 2 arm study will compare the efficacy and safety of the standard chemotherapy of the
      East German Study Group for Hematology and Oncology versus standard chemotherapy plus
      MabThera (375mg/m2 iv, once monthly for 8 cycles) in patients with indolent non-Hodgkin's and
      mantle cell lymphoma. The anticipated time on study treatment is 3-12 months, and the target
      sample size is 100-500 individuals.
    


Intervention name(s): rituximab [MabThera/Rituxan]; Standard chemotherapy
Intervention type(s): Drug; Drug
Intervention description(s): 375mg/m2 iv monthly for 8 cycles; As prescribed
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacodynamic Study to Compare Acute Effects of Dihydroergotamine Mesylate (DHE) on Pulmonary Arterial Pressure
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Compare the acute effects and tolerability of Dihydroergotamine Mesylate (DHE) delivered by
      Oral Inhalation (MAP0004) versus by intravenous (IV) infusion in healthy adult volunteers.
    


Intervention name(s): MAP0004; IV Placebo (Saline); Placebo Inhaler; IV Dihydroergotamine Mesylate (DHE)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1.0 mg orally inhaled MAP0004 administered in Treatment B as per protocol; IV Placebo (Saline) administered in Treatment B and Treatment C as per protocol; Orally inhaled Placebo administered in Treatment A and Treatment C as per protocol.; IV DHE administered in Treatment A as per protocol
Other intervention name(s): D.H.E.45®
Intervention MeSH terms: Dihydroergotamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy volunteers
A Study of LY3844583 in Healthy Participants and Participants With Atopic Dermatitis
Condition: Healthy; Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety and tolerability of LY3844583 in
      healthy participants and participants with atopic dermatitis. The study will also assess how
      fast LY3844583 gets into the blood stream and how long it takes the body to remove it. The
      study is open to healthy participants and participants with atopic dermatitis. The study will
      be conducted in three parts and each participant will enroll in one part. The study will last
      up to 88, 116, and 186 days with 10, 13, and 14 visits for each participant in parts A, B,
      and C, respectively.
    


Intervention name(s): LY3844583; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC and/or IV.; Administered SC and/or IV.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
To Evaluate Plasma and Pulmonary Pharmacokinetics of GSK2140944
Condition: Infections, Bacterial
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Antimicrobial penetration can be assessed through evaluation of antimicrobial concentrations
      in various lung compartments, including bronchial mucosal tissue, epithelial lining fluid
      (ELF), and alveolar macrophages (AM). Antimicrobial concentrations determined in ELF and
      alveolar macrophages represent an ideal estimate of concentrations at the site of infection
      and can be accessed via bronchoalveolar lavage (BAL). However sampling of antimicrobial
      concentrations via BAL is not routine in clinical practice due to its complex methodology and
      poor patient tolerability. This study will evaluate intrapulmonary and plasma
      pharmacokinetics of GSK2140944 after single IV dose in adult healthy volunteers. This is a
      Phase I, open-label study to evaluate plasma and pulmonary pharmacokinetics following
      intravenous administration of GSK2140944 in healthy adult participants. Part A will evaluate
      the single dose PK profiles. Part B is optional and will only be conducted if necessary. Each
      part will consist of a maximum of 6 cohorts. In Part A, only 4 of the 6 cohorts will be dosed
      initially; cohorts 5 and 6 are optional and will only be dosed if additional time-points are
      necessary to adequately model the pulmonary pharmacokinetic profile.
    


Intervention name(s): GSK2140944 (Single dose); GSK2140944 (Multiple dose)
Intervention type(s): Drug; Drug
Intervention description(s): A lyophilized formulation, pale yellow to grayish yellow cake containing 750 mg of GSK2140944 (as free base) per vial, Administered intravenously as a single dose.; A lyophilized formulation, pale yellow to grayish yellow cake containing 750 mg of GSK2140944 (as free base) per vial, Administered intravenously every 12 hours for 5 doses (3 days).
Intervention MeSH terms: Gepotidacin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GSK2140944; pharmacokinetics; bronchoalveolar lavage; pulmonary; antimicrobial; healthy volunteer
Effects of Providing Preprint Preoperative Anesthetic Risk Information
Condition: Preoperative Anxiety
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Proportion of patients in study group(preprint preoperative anesthetic risk should have more
      anxiety, more knowledge, and more cancellation than controlled group
    


Intervention name(s): preprint preoperative anesthetic risk information
Intervention type(s): Other
Intervention description(s): preprint preoperative anesthetic risk information
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anxiety; preprint anesthetic risk information
Intraligamental Local Anesthesia Versus Infiltration Technique for Extraction of Grade II Mobility Maxillary Molars
Condition: Anesthesia, Local
Study type: Interventional

Summary: 
      The study aims to assess the use of intraligamental local anesthetic injection compared to
      buccal infiltration for extraction of maxillary molars suffering grade II mobility in terms
      of pain control and extraction duration.
    


Intervention name(s): Intraligamental local anesthetic injection
Intervention type(s): Procedure
Intervention description(s): The intraligamental technique was administered using ligajet intraligamentary jet injector (Micro Mega Company) containing Articaine hydrochloride 4% with adrenaline 1:200000 (ArtPharma Dent, inc, Egypt)
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Chronotropic Incompetence During Exercise in Obese Adolescents: Clinical Implications and Pathophysiology
Condition: Obesity; Adolescent Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      A reduction in peak heart rate (HR) and suppressed HR response during exercise is highly
      prevalent in obese populations. This phenomenon is also known as chronotropic incompetence
      (CI). In adult obese individuals, CI is independently related to elevated risk for major
      adverse cardiovascular events and premature death. Despite the established association
      between CI and prognosis in adult populations, the prognostic relevance of CI in adolescents
      with obesity has however deserved no attention, but is important. CI during exercise testing
      may indicate various, yet undetected anomalies, such as altered blood catecholamine and/or
      potassium concentrations during exercise, structural myocardial abnormalities or ventricular
      stiffness, impaired baroreflex sensitivity and cardiovascular autonomic dysfunction,
      atherosclerosis, or cardiac electrophysiological anomalies, which all have been detected in
      obese children and adolescents. However, whether CI during exercise testing may be a
      sensitive and specific indicator for these anomalies in obese adolescents has not been
      studied yet. In addition, the exact physiology behind obesity and development of heart
      disease remains to be studied in greater detail in obese adolescents. In this project, we
      examine the prevalence of CI (during maximal cardiopulmonary exercise testing, CPET) in 60
      obese adolescents (aged 12-16 years) vs. 60 lean adolescents, and study the association
      between CI and changes in CPET parameters, lactate, catecholamine and potassium
      concentrations during CPET, biochemical variables, and cardiac electrophysiology (by ECG
      recording). In addition, the relation between CI and cardiac function (echocardiography) will
      be examined in a subgroup (29 lean and 29 obese) of these adolescents. In this regard, the
      diagnostic value of HR (responses) during maximal exercise testing will be clarified in obese
      adolescents, and the physiology behind the elevated risk for heart disease in obese
      adolescents can be explored.
    


Intervention name(s): the prevalence of chronotropic incompetence CI during maximal cardiopulmonary exercise testing, CPET
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar Rapid-Acting Insulin Aspart (I004) and NovoLog After Single-Dose Subcutaneous Administration to Healthy Volunteers
Condition: Pharmacokinetics; Pharmacodynamics
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study is a randomized, double-blinded, two-treatment, two-period, two-sequence crossover
      pivotal Biosimilar study. The purpose of this study is to establish pharmacokinetic (PK) and
      pharmacodynamics (PD) biosimilarity of proposed biosimilar I004 and the US-approved NovoLog.
    


Intervention name(s): I004; NovoLog
Intervention type(s): Drug; Drug
Intervention description(s): Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition.; Drug will be administered via subcutaneous injection into the abdominal wall of the peri-umbilical area with a dose of 0.2 units/kg based on the body weight measured at Treatment Period 1 under fasting condition.
Other intervention name(s): Insulin Aspart, a rapid-acting human insulin analogue; Insulin Aspart, a rapid-acting human insulin analogue
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: insulin aspart
Pilot Study to Evaluate Daily Protein's Intake Following Bariatric Surgery by Using the Software Protein Assistant
Condition: Obesity
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effect of the use of Protein Assistant on the daily
      protein intake in obese patients who underwent a bariatric surgery (in the 3 months following
      surgery).
    

Detailed description: 
      After a bariatric surgery, food intake is reduced. Patients should favor proteins to avoid
      loss of muscles. The guidelines recommend a minimal protein's intake of 60g per day. But this
      goal is achieved only for 55 to 60 % patients 4 months after surgery and 50 à 65 % patients
      at one year.

      Protein assistant is a software which can calculate the amount of proteins eaten per day and
      can propose solutions if the intake is insufficient.

      The main objective of this study is to evaluate the effect of the use of Protein Assistant on
      the daily protein intake in obese patients who underwent a bariatric surgery (in the 3 months
      following surgery).

      Protein Assistant is suggested 1 month after bariatric surgery on a digital tablet. The
      patient is educated to use Protein Assistant. The patient has to complete a dietary record
      every 2 weeks during 2 months. The aim is to intake 60g per day. If the aim is not reached,
      Protein assistant suggests qualitative and/or quantitative solutions.
    

Intervention name(s): use of Protein Assistant
Intervention type(s): Other
Intervention description(s): The patient has to complete a dietary record every 2 weeks during 2 months (month 2 and 3 after surgery). The aim is to intake 60g per day. If the aim is not reached, Protein assistant suggests qualitative and/or quantitative solutions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: bariatric surgery
Safety, Pharmacokinetics, and Pharmacodynamics of BIRT 2584 XX Administered as Multiple Doses and Safety and Pharmacokinetics of BIRT 2584 XX Administered With and Without Food as Single Dose to Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study comprised two parts. The objective of the first study period was to assess the
      safety and pharmacokinetics of 500 mg of BIRT 2584 XX tablets administered with and without
      food in male healthy volunteers and to determine the relative bioavailability of the BIRT
      2584 XX tablet formulation compared by historical comparison to BIRT 2584 XX powder in PEG
      400 (U05-2074) (part 1). The second and major phase of the trial was aimed at evaluating the
      safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple rising doses of BIRT
      2584 XX (100 mg, 250 mg, and 500 mg bid on the first 2 days and qd on the following 12 days,
      or 750 mg qd for 28 days) in healthy male subjects (part 2)
    


Intervention name(s): BIRT 2584 XX - multiple escalating dose; Placebo; BIRT 2584 XX - single dose; high caloric meal
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): 30 minutes prior to the second drug administration after a one week wash-out period, a standardised high fat, high caloric meal was served
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
The Effect of n-3 Fatty Acids and Fish on Glucose and Lipid Metabolism in Subjects With Impaired Glucose Metabolism
Condition: Hyperglycemia
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      The aim of the project is to examine whether the sources of n-3 fatty acids and fish itself
      differ in their effects on glucose metabolism, lipid metabolism, blood pressure, and serum
      inflammatory markers. Lipidomic profiles and gene expression will be used for thorough
      assessment of the possible clinical changes. The study will compare the effects of
      alpha-linolenic acid containing vegetable oil, fatty fish, lean fish and control diet. The
      results of this project will help to identify the optimal source of n-3 fatty acids, and
      reveal the significance of the components of fish other than fatty acids. These data will be
      useful both nationally and internationally, since highly controlled dietary interventions
      utilizing new methodology are scarce.
    


Intervention name(s): Fatty fish; Lean Fish; Alpha-linolenic acid; Control
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)