bioihbjkbjnl/mcl2 huggingface dataset:
Study in Healthy Volunteers to Assess the Pharmacokinetics (PK) of Digoxin Administered Alone and in Combination With Vandetanib
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study in healthy volunteers to assess the pharmacokinetics (PK) of Digoxin
      administered alone and in combination with Vandetanib.
    

Detailed description: 
      A Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of Digoxin in
      Healthy Subjects When Administered Alone and in Combination with a Single Dose of Vandetanib
      (CAPRELSA) 300 mg
    

Intervention name(s): Digoxin; Vandetanib
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablets 0.25mg, single dose; Oral tablets, 300 mg, single dose
Intervention MeSH terms: Digoxin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; healthy volunteers; pharmacokinetics; vandetanib; digoxin
The Primary Objective of This Study is to Determine Whether MICARDIS® Improves Insulin Sensitivity in Overweight or Obese, Non-diabetic, Normotensive Subjects
Condition: Obesity; Insulin Resistance
MeSH terms: Overweight; Insulin Resistance
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to determine whether MICARDIS® improves insulin
      sensitivity in overweight or obese, non-diabetic, normotensive subjects.
    


Intervention name(s): MICARDIS® (telmisartan)
Intervention type(s): Drug
Intervention MeSH terms: Telmisartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Preoperative Anxiety on Postoperative Outcome and Sleep Quality in Patients Undergoing Laparoscopic Hysterectomy
Condition: General Anesthesia; Postoperative Pain; Postoperative Sleep Quality; Preoperative Anxiety
MeSH terms: Anxiety Disorders
Study type: Observational

Summary: 
      Sleep is a naturally occurring state of decreased arousal that is crucial for normal immune
      and cognitive function. Although surgery and anesthesia techniques have improved in recent
      years, sleep function and sleep cycles may still be altered perioperatively by surgery and
      other interventions under general anesthesia.Postoperative sleep fragmentation and poor sleep
      quality not only lead to hyperalgesia and delayed postoperative recovery, but can increase
      the risk of potential adverse effects, such as cognitive impairment, chronic pain and
      emotional disturbances, metabolic disorders, and pro-inflammatory changes. General anesthesia
      is a medically induced state of hyporesponsiveness that resembles natural sleep. Studies have
      shown that general anesthesia can lead to circadian rhythm time structure dyssynchrony,
      resulting in postoperative sleep disturbance, characterized by decreases in rapid eye
      movement (REM) and slow wave sleep (SWS). Previous studies have also reported that age,
      preoperative comorbidities, and severity of surgical trauma are independent factors
      associated with postoperative sleep disturbance. In addition, anxiety is an unpleasant
      sensation that compromises patients' comfort and well-being. A study by Ruis et al. estimated
      that 25-80% of patients admitted for surgery experienced preoperative anxiety, including fear
      of surgery and anesthesia-related fears. Furthermore, preoperative anxiety was recognized as
      a potential and preventable risk factor for severe postoperative pain and postoperative
      complications such as increased postoperative morbidity and mortality. Given that several
      prior studies have reported that preoperative anxiety has an effect on postoperative sleep
      quality in patients undergoing gynecological surgery, this study aimed to investigate the
      effect of preoperative anxiety on postoperative outcomes and sleep quality in patients
      undergoing gynecological surgery. Studying these results could enable us to better manage
      patients during the perioperative period to promote their postoperative recovery.
    


Intervention name(s): patients undergoing gynecological surgery under general anesthesia
Intervention type(s): Procedure
Intervention description(s): patients undergoing gynecological surgery under general anesthesia
Intervention MeSH terms: Anesthetics
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This study enrolled patients undergoing gynecological surgery under general anesthesia at
        Shengjing Hospital of China Medical University.
Effects of Continous Positive Airway Pressure (CPAP) in Hypertrophic Cardiomyopathy
Condition: Non-obstructive Hypertrophic Cardiomyopathy; Obstructive Hypertrophic Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Hypertrophic; Hypertrophy
Study type: Interventional

Summary: 
      Hypertrophic cardiomyopathy (HCM) is the most common genetic cardiac disease, is a cause of
      disability including heart failure, atrial fibrillation, and sudden death, with an annual
      mortality varying from 1% to 6%. Obstructive sleep apnea (OSA) is extremely common among
      patients with established cardiovascular disease, including hypertension and atrial
      fibrillation and when present may contribute to worse cardiovascular outcome. Although
      patients with HCM do not necessarily have typical characteristics of patients with OSA, such
      as obesity and increasing age, there is recent evidence that OSA is extremely common among
      patients with HCM, with a prevalence ranging from 32% to 71%. The presence of OSA among
      patients with HCM is independently associated with worse structural and functional impairment
      of the heart, including atrial and aorta enlargement, worse New York Heart Association
      functional class, and worse quality of life. Therefore, the recognition and treatment of OSA
      is a new area of research that may impact in the management of patients with HCM.
    


Intervention name(s): CPAP
Intervention type(s): Device
Intervention description(s): A low or high CPAP pressure is delivered for 20 minutes
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: CPAP; Hypertrophic cardiomyopathy; Blood Pressure; The focus of the present study is to evaluate the acute hemodynamic effects of CPAP in patients with non-obstructive and obstructive hypertrophic cardiomyopathy
A Phase I Study of AG-348 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a dose escalation study that will be conducted in healthy volunteers. Multiple
      cohorts of volunteers will receive ascending oral doses of AG-348 to evaluate the safety and
      tolerability of a single oral dose of AG-348, the pharmacokinetics (PK) of a single dose of
      AG-348, and the pharmacodynamic profile of AG-348 with specific biomarkers assessed in the
      blood.
    


Intervention name(s): AG-348; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A range of doses of AG-348 will be tested based on assessment of safety and tolerability.
Other intervention name(s): AG-348 will be administered as a single oral dose on Day 1.; Placebo will be administered as a single oral dose on Day 1.
Intervention MeSH terms: Mitapivat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: safety and tolerability; pharmacokinetic study
A Novel Approach for Transjugular Intrahepatic Portocaval Shunt Creation Using Real-time Three Dimensional Roadmap
Condition: Portal Hypertension
MeSH terms: Hypertension, Portal
Study type: Interventional

Summary: 
      TIPS creation has been widely used to treat the complications associated with portal
      hypertension. In association with increased operator experience and the ongoing development
      of imaging modalities, the rate of major complications associated with TIPS has decreased
      significantly in the past decades. However, the passage of a curved needle from the hepatic
      vein into the portal vein still remains a challenging and time-consuming part of the
      procedure and is associated with puncture-related complications that are potentially
      fatal.Three-dimensional roadmap guidance has been widely applied in various interventions.
      The aim of the present study is to prospectively assess the feasibility and efficacy of
      real-time 3D roadmap guidance during TIPS creation.
    


Intervention name(s): 3d roadmap guidance; conventional TIPS procedure
Intervention type(s): Other; Other
Intervention description(s): TIPS was established using 3d roadmap; conventional TIPS procedure using wedged hepatic venography
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: TIPS creation using real-time 3D roadmap
Masking: None (Open Label)
Primary purpose: Treatment
Assessment of a Vaginal Ring With Meloxicam on Ovarian Cycle in Fertile Women
Condition: Contraception; Bleeding Pattern
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study, the investigators propose to assess if a non-hormonal agent is absorbed by a
      local route (vaginal) and to observe the effect on follicular development.
    

Detailed description: 
      Each volunteer will participate for 3 menstrual cycles, beginning with one menstrual control
      cycle without treatment, following by one menstrual cycle with meloxicam ring administration,
      and finishing with another control menstrual cycle.

      Meloxicam will be administered in the second menstrual cycle via a vaginal ring in two doses
      of 2.4 g or 3.0 g/ring. The safety of the vaginal ring and the absorption of meloxicam will
      be assessed. Also the effect on follicular development and if it maintains ovarian cyclicity,
      as shown in a recent study with oral administration, will be assessed.
    

Intervention name(s): Meloxicam 2.4 g; Meloxicam 3.0 g
Intervention type(s): Drug; Drug
Intervention description(s): 2.4 g in Vaginal Ring; 3.0 g in Vaginal Ring
Intervention MeSH terms: Meloxicam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: pharmacokinetic
A Study to Assess the Relative Oral Bioavailability and Food Effect of Single-dose of JNJ-64417184 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the relative bioavailability of JNJ-64417184,
      formulated as a test formulation (tablet) compared to a reference formulation (suspension),
      administered orally in a fasted state, in healthy participants.
    


Intervention name(s): JNJ-64417184 600 (Oral Tablet Formulation); JNJ-64417184 (Oral Suspension Formulation)
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive 600 mg of JNJ-64417184 as oral tablet.; Participants will also receive JNJ-64417184 600 mg as oral suspension.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Personalized Obesity Management - Matching Dietary Fibers and Microbial Enterotype
Condition: Overweight and Obesity; Weight Loss
MeSH terms: Obesity; Overweight; Weight Loss
Study type: Interventional

Summary: 
      The overall aim of this 12-week randomized controlled trial is to investigate if a dietary
      fiber supplement rich in arabinoxylans (AX) affects weight loss success differently according
      to baseline gut microbiota composition in subjects who have overweight or obesity.

      105 participants will be randomized in a 2:1 ratio to receive 15 g/day of AX or placebo.
    

Detailed description: 
      First, we hypothesize that participants who have a predominantly Prevotella enterotype
      (inferred by a high Prevotella/Bacteroides-ratio) will lose more body weight after AX
      supplementation compared to participants with a predominantly Bacteroides enterotype
      (inferred by a low Prevotella/Bacteroides-ratio). Specifically, we hypothesize that weight
      loss and P/B-ratio will be positively correlated in the AX supplementation-group whereas
      there will be no such correlation in the control-group. Consequently, we hypothesize that
      participants with the Bacteroides enterotype - and the lowest P/B-ratio - will have no
      benefit after AX supplementation while the weight loss effect of the AX supplementation will
      increase with increasing P/B-ratio.

      Second, we hypothesize that the ability to digest starch in the upper gastrointestinal tract
      - evaluated by salivary alpha amylase gene (AMY1) copy number - will influence the
      interactions among AX intake, P/B ratio, and body weight change. Specifically, we hypothesize
      that there will be an association between body weight change and P/B ratio among subjects
      with a low AMY1 copy number, but not among the ones with a high AMY1 copy number, when
      consuming AX.
    

Intervention name(s): Arabinoxylan; Control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Dietary fiber product; Potato starch
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Gut microbiota; Dietary fiber
Effects Of Single Doses Of GW784568X On Allergic Rhinitis Symptoms In Male Subjects Whilst In An Environmental Chamber
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was designed to look at safety aspects and effects of intranasal doses of
      GW784568X on allergic rhinitis symptoms to develop this drug for its use in people who suffer
      with allergic rhinitis
    

Detailed description: 
      A randomised, placebo-controlled, 4-period, incomplete block, crossover study of 7 days
      dosing of intranasal GW784568X (100mcg, 200mcg and 400mcg od), fluticasone propionate (200mcg
      od) and placebo (blinded for GW784568X vs placebo) to evaluate the efficacy and safety using
      an environmental chamber in male subjects with allergic rhinitis
    

Intervention name(s): GW784568X; Fluticasone propionate; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GW784568X will be delivered as a micronized suspension (50 or 100mcg/spray) via an aqueous nasal spray. Dose planned for treatment groups are 100, 200 and 400 mcg.; Fluticasone propionate will be delivered 50 mcg/spray and planned dose is 200 mcg.; Matching Placebo to GW784568X as aqueous nasal spray.
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Treatment
Keywords: Environmental Challenge Chamber; GW784568X; Intranasal
Trial of Oxaliplatin, Cytosine Arabinoside, Dexamethasone With Rituxan (ROAD) in Patients With Relapsed Non-Hodgkins Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      The goals of this protocol are to determine the effect of oxaliplatin, cytosine arabinoside,
      and dexamethasone with Rituxan (ROAD) as treatment for patients with relapsed CD20+ B-cell
      non-Hodgkins lymphoma (NHL).
    

Detailed description: 
      Patients with B-cell NHL that comes back after chemotherapy are typically treated with
      cisplatin, high-dose cytosine arabinoside and dexamethasone (DHAP) or other platinum-based
      treatments. Recent studies have shown a 37% response rate in patients with large cell
      lymphoma to immunotherapy with Rituxan. Patients <75 years old and in otherwise good health
      may be candidates for high dose therapy with stem cell rescue if they have disease that
      remains sensitive to chemotherapy. Typically, patients are administered 2 cycles of DHAP or
      ICE (ifosfamide, carboplatin, and etoposide) and, if the disease responds, they proceed to
      high-dose therapy with stem cell support. Even patients not considered transplant candidates
      are also often treated with DHAP or ICE or other salvage regimens. It is likely that the
      response rate with DHAP alone in patients eligible for transplant is <59%. Recent studies
      have attempted to improve on the results from DHAP or ICE by combining them with rituxan.
      NCCTG has just completed a phase II trial of R-DHAP. Preliminary results of the R-ICE
      protocol indicate a higher response rate and longer time to progression than traditional ICE.

      The problem with DHAP and ICE is that they are associated with significant side effects and
      specifically, with DHAP the cisplatin often causes kidney problems. In fact, some patients
      who are considered transplant eligible before DHAP may become transplant ineligible simply by
      the kidney side effects. Clearly, there is a need to improve the quality of life of patients
      undergoing treatment and to avoid the kidney problems.
    

Intervention name(s): Oxaliplatin, Cytosine Arabinoside, Dexamethasone With Rituxan (ROAD)
Intervention type(s): Drug
Intervention description(s): rituximab 375 mg/m2 IV Weekly x 4 1 cycle only
dexamethasone 40 mg PO/IV Days 2-5 q 21 days 2 cycles
oxaliplatin 130 mg/m2 IV Day 2 q 21 days 2 cycles
cytosine arabinoside 2000 mg/m2 x 2 doses IV Days 2-3 q 21 days 2 cycles
pegfilgrastim 6 mg SQ Day 4 q21 days 2 cycles
Intervention MeSH terms: Cytarabine; Dexamethasone; Oxaliplatin; Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: C04.557.386
A Controlled Study on Regulation of Systemic Inflammation by Fecal Bacteria Transplantation in Patients With COVID-19.
Condition: Fecal Microbiota Transplantation; COVID-19 Infection
MeSH terms: COVID-19; Inflammation
Study type: Interventional

Summary: 
      A total of 30 hospitalized patients with COVID-19 over 60 years old were enrolled in this
      study and were divided into the experimental group (n=15) and the control group (n=15) at a
      ratio of 1:1. Both groups were treated according to the 2022 Shanghai guidelines for
      Diagnosis and Treatment of COVID-19 infection and the hierarchical diagnosis and treatment
      process. The experimental group was treated with fecal microbiota transplantation (FMT)
      capsules for 1 week, and the control group was treated with empty capsules. Patients in both
      groups were followed up for 1 month after discharge. To observe the effect of combined FMT
      capsule treatment on the regulation of inflammatory factors in peripheral blood and the
      remodeling of intestinal flora, and to verify its safety.
    


Intervention name(s): Fecal microbiota transplantation
Intervention type(s): Procedure
Intervention description(s): Fecal microbiota transplantation (FMT) is the use of functional microorganisms in the feces of healthy people to form capsules and orally administer them to the intestinal tract of patients to reconstruct the intestinal flora of patients, so as to achieve the purpose of treating intestinal and exenteric diseases.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Types of Starch and Their Effect on Blood Glucose, Appetite and Food Intake
Condition: Obesity Prevention; Diabetes Prevention
Study type: Interventional

Summary: 
      The investigators hypothesize that different types of starch vary in their effects on
      appetite, blood sugar and food intake. In this study, subjects consumed five soups containing
      50 g of whole grain, high amylose corn, regular corn or maltodextrin starches or no added
      starch at one week intervals. The investigators measured food intake at 120 minutes, appetite
      and blood sugar.
    


Intervention name(s): Dietary Intervention
Intervention type(s): Other
Intervention description(s): soup with or without starch
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: starch; carbohydrates; blood glucose; food intake; satiety; appetite
The Transtheoretical Model For Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      The main objective of this study was to investigate the impact of individual counseling
      programs which has been designed from the Transtheoretical Model (TM) suggesting a healthy
      diet and physical activity for the students diagnosed with PCOS in the management of their
      syndrome. The data for the analysis was drawn from a sample of 854 students at first and a
      totally of 67 students were administered the scales. The control (N=33) and experimental
      groups (N=34) were formed based on a simple randomization technique.
    


Intervention name(s): Individual counselling program
Intervention type(s): Other
Intervention description(s): An individual counseling program that was based on TM and included motivational interview techniques was given to the experimental group which involved general information about the importance of weight control, healthy diet, and exercise.
Benefits of Healthy Diet and Physical Activity in PCOS Training Booklet was given during their first counseling session.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: transtheoretical model; individual counselling; university students
Impact of Three Different Education Methods on Oral Hygiene
Condition: Oral Hygiene
Study type: Interventional
Phase: Early Phase 1

Summary: 
      In the present study, 144 children (72 males and 72 females), whose ages ranged between 8-13,
      were divided into 12 equal experimental groups according to their ages and gender. They were
      all considered to have poor hygiene. Only one out of the three different education methods
      (brochure, model or video) was applied to each group. The percentage change in PI, GI, BOP
      and theoretical test points from the baseline to the 6th months were evaluated.
    

Detailed description: 
      Aim: The aim the present study was to evaluate the impact of three different education
      methods on the oral hygiene levels of school children using clinical and theoretical
      findings.

      Methods: In the present study, 144 children (72 males and 72 females), whose ages ranged
      between 8-13, were divided into 12 equal experimental groups according to their ages and
      gender. They were all considered to have poor hygiene. Only one out of the three different
      education methods (brochure, model or video) was applied to each group. The percentage change
      in PI, GI, BOP and theoretical test points from the baseline to the 6th months were
      evaluated. The data was statistically analysed by using Kolmogorov-Smirnov and One-way ANOVA
      tests.
    

Intervention name(s): Non-surgical periodontal treatment
Intervention type(s): Other
Intervention description(s): Scaling and oral hygiene instructions with brochure, model or video
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention