bioihbjkbjnl/mcl2 huggingface dataset:
The Value of HBA in the Evaluation of Idiopathic Infertility
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      We would like to determine if HBA® testing of sperm in couples with presumed idiopathic
      infertility will reveal lower binding percentages than in couples with an identifiable cause
      of infertility either male factor or tubal factor
    

Detailed description: 
      We would like to determine if HBA® testing of sperm in couples with presumed idiopathic
      infertility will reveal lower binding percentages than in couples with an identifiable cause
      of infertility either male factor or tubal factor We would like to determine if patients with
      abnormal HBA binding have decreased IVF outcome: decreases clinical pregnancy rate,
      implantation rate, and increased miscarriage rate
    

Intervention name(s): HBA binding assay
Intervention type(s): Other
Intervention description(s): HBA binding assay will be preformed on the discarded portion of semen analysis used for IVF.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Assessing Adherence to Home Telemedicine in Individuals With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      This is a single-site feasibility pilot study to determine if patients with COPD with an
      increased risk of exacerbation will use an in-home COPD telemonitoring system for three
      months that collects lung measures, pulse oximetry, and medication compliance.
    

Detailed description: 
      This is a single-site, prospective, open label trial evaluating home telemonitoring for
      patients with COPD and a history of increased exacerbation risk. The purpose of this study is
      to determine whether automated home monitoring of medication compliance and biometric
      parameters [forced expiratory capacity in one second (FEV1), forced vital capacity (FVC),
      peak inspiratory flow rate (PIFR), inspiratory capacity (IC), pulse oximetry, and symptoms]
      is acceptable to patients, can improve adherence, and may improve clinical outcomes and
      reduce exacerbations and avoidable 30-day readmissions. Slow spirometry will be performed
      Sundays, Mondays, Wednesdays, Fridays and Saturdays. Forced spirometry will be performed
      Tuesdays and Thursdays.
    

Intervention name(s): Go Home tablet with linked GoSpiro and 3230 Pulse Oximeter
Intervention type(s): Device
Intervention description(s): All participants will receive the intervention consisting of a home telemedicine tablet platform (GoHome) that will collect multiple spirometry tests each week (including both forced and slow spirometry measurements), pulse oximetry, and QoL Questionnaire responses. The platform will remind patients to take their medications remind patients to perform measurements, send patients helpful information, and execute a UNC clinic established COPD Action Plan.The backend of the platform is a remote server (Monitored Therapeutics CarePortal) that collects the data, send out alerts to the Principal Investigator and can track and trend the data for them.
Intervention model: Single Group Assignment
Intervention model description: All participants will receive the intervention consisting of a home telemedicine tablet platform (GoHome) that will collect multiple spirometry tests each week (including both forced and slow spirometry measurements), pulse oximetry, and quality of life (QoL) Questionnaire responses. The platform will remind patients to take their medications remind patients to perform measurements, send patients helpful information, and execute a University of North Carolina (UNC) clinic established COPD Action Plan.The backend of the platform is a remote server (Monitored Therapeutics Incorporated CarePortal) that collects the data, send out alerts to the Principal Investigator and can track and trend the data for them.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: home telemedicine; home spirometer
Impact of Health Literacy on Outcomes and Effectiveness of Shared Decision Making Programs in Patients With Chronic Diseases
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Chronic Disease
Study type: Interventional

Summary: 
      Study objective was to explore the impact of health literacy on effectiveness of an
      educational intervention describing life-style and behavior modification for patients "Living
      with Coronary Artery Disease." Our hypothesis was that a VHS/DVD version of this educational
      program would be "superior" to printed material alone in its impact on patients' knowledge
      about coronary artery disease and important life-style changes. Furthermore, we believed this
      effect would be most notable among patients with low health literacy. We also were interested
      in the impact of the interventions on secondary outcomes including - health behaviors, health
      outcomes and patients' subjective experiences.
    

Detailed description: 
      187 patients with coronary artery disease (CAD) were randomized to one of two educational
      interventions prior to scheduled ambulatory visit: VHS/DVD plus printed booklet; or booklet
      alone. Main measures included health literacy, CAD knowledge assessment; clinical outcomes
      and health behaviors including - blood pressure, weight, smoking status, exercise and dietary
      habits.
    

Intervention name(s): Educational Intervention - Text plus DVD/VHS; Educational Intervention - Text Only
Intervention type(s): Behavioral; Behavioral
Intervention description(s): In conjunction with a scheduled clinical visit, consenting patients spent roughly 40 minutes viewing a video program developed by the Foundation for Informed Decision Making (FIMDM), describing life-style and behavior modification for patients "Living with Coronary Artery Disease." They also were given a booklet on the same subject material written at a 5th grade level.; In conjunction with a scheduled clinical visit, consenting patients spent roughly 40 minutes reading a booklet developed by the Foundation for Informed Decision Making (FIMDM), describing life-style and behavior modification for patients "Living with Coronary Artery Disease." Subject material was written at a 5th grade level.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Health literacy; patient education; health behaviors; chronic disease management; shared decision-making; patient-centered decision making
ABT-450 With Ritonavir and ABT-267 and/or ABT-333 With and Without Ribavirin in Genotype 1 Hepatitis C Virus Infected Patients
Condition: Chronic Hepatitis C; Hepatitis C (HCV); Hepatitis C Genotype 1
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study of combination direct-acting antiviral agents (DAA) with or without ribavirin
      (RBV) in patients with chronic Hepatitis C Virus (HCV).
    

Detailed description: 
      A study to evaluate the safety and effectiveness of experimental drugs ABT-450, ABT-267 (also
      known as ombitasvir), ABT-333 (also known as dasabuvir), ritonavir, and ribavirin in
      participants with HCV. The study will test the safety and effects of combinations of these
      drugs in treatments up to 24 weeks.
    

Intervention name(s): ABT-450; ABT-333; ABT-267; Ribavirin; Ritonavir
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): ABT-450 tablets; ABT-333 tablets; ABT-267 tablets; Ribavirin tablets administered at a weight-based dose, between 1,000 to 1,200 mg daily (divided).; Ritonavir capsules
Other intervention name(s): Dasabuvir; Ombitasvir; Norvir
Intervention MeSH terms: Ritonavir; Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C Genotype 1; Hepatitis C; Interferon-Free; HCV; Chronic Hepatitis C
Cytokine-Associated Depression and Social Pain
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Recent research has demonstrated a relationship between depression and immune system
      activity, specifically proinflammatory cytokine activity. Although experimentally-induced
      immune activation leads to increases in depressed mood, the neural correlates associated with
      these changes have remained largely unexplored. Based on relationships between cytokine
      activity, depression, and heightened physical and social pain sensitivity, I propose to
      investigate the effect of proinflammatory cytokine activation on the neural correlates of
      socially painful experience that may contribute to depression. Our previous work has shown
      that the dorsal anterior cingulate cortex (dACC), typically associated with physical pain
      distress, also plays a role in the distressing feelings associated with social rejection or
      social loss. Moreover, recent pilot data has revealed that individuals with elevated levels
      of baseline proinflammatory cytokines report feeling more distressed and show more dACC
      activity during social rejection. To investigate the causal role that cytokines may play in
      the heightened social pain sensitivity that can contribute to depression, participants will
      be randomly assigned to receive either endotoxin (which increases proinflammatory cytokine
      activity) or placebo. Subsequently, participants will complete a neuroimaging study in which
      they will be rejected during an online ball-tossing game. We hypothesize that individuals
      exposed to endotoxin will report more social distress and depression following rejection and
      will show more dACC reactivity during rejection. The proposed study is the first to
      investigate the effect of systemic inflammation on neural reactivity related to social and
      affective processes that may increase the risk of depression.
    


Intervention name(s): Endotoxin
Intervention type(s): Drug
Primary purpose: Basic Science
Keywords: Effect of Inflammatory challenge on depressed mood; Effect of inflammatory challenge on social pain
Estimation of Autonomic Nervous System Modulation by Pulse Plethysmographic Analysis
Condition: Autonomic Nervous System Modulation
Study type: Interventional

Summary: 
      Novel pulse plethysmography-derived indexes has been proposed as a tool to measure autonomic
      nervous system modulation in anaesthetized and awake patients, but nowadays a physiologic
      validation is lacking. We aim to examine the effects of sympathetic stimulation on pulse
      plethysmographic amplitude (PPGA), autonomic nervous system state (ANSS) and autonomic
      nervous system state index (ANSSi).
    

Detailed description: 
      It has been supposed that indexes derived from pulse plethysmographic analysis -the autonomic
      nervous system state (ANSS) and ANSS index (ANSSi)- may be useful tools to measure the
      autonomic nervous system (ANS) activity but, to date, physiologic experimental evidences are
      lacking.

      Traditionally,it is widely accepted that ANS modulation and the baro-reflex control can be
      non-invasively studied through heart rate variability (HRV) and systolic variability
      analyses.

      The aim of this study is to assess if PPGA-derived indexes are able to detect changes of ANS
      system modulation directed to heart and vessels.

      Changes in position of patients lead to changes in the balance of the ANS. One of the most
      used manoeuver to stimulate ANS is head-up tilt (HUT). Tilt causes pooling of blood toward
      lower body and reduces the venous return to the heart. These activation of ANS leads to an
      increase of heart rate and peripheral vascular resistance aiming to maintain arterial
      pressure near to the level preceding the challenge (baro-reflex control).

      Methods: we study the effects of sympathetic stimulation on ANSS and ANSSi induced with two
      different tilt at 45 and 90 degrees angles. We compare the ANSS and ANSSi with HRV analysis
      and baro-reflex control analysis. We plan to study 7 volunteers to detect a difference of 30
      (standard deviation of 15) between the mean of ANSS and ANSSi at baseline and during tilt,
      with a power of 80% and alfa error of 5%.
    

Intervention name(s): Tilt test
Intervention type(s): Other
Intervention description(s): The experiment protocol consists of a sequence of passive postural changes gained with a tilt table, each of them lasting 10 minutes. The sequence consists of: (i) baseline recording in supine position; (ii) tilt at 45 degrees angle; (iii) recovery period in supine position; (iv) tilt at 90 degrees angle and (v) recovery in supine position.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pulse plethysmography, autonomic nervous system, heart rate variability, baro-reflex
Oro-gastro-intestinal Digestion of Emulsified Fat
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Interaction of fat with the mouth, stomach and intestine will trigger physiological responses
      that will impact on the digestion, gut transit time and absorption of fat. These responses
      will also influence and contribute to regulation of food intake and satiety. No systematic
      research on understanding how the physiological-chemical properties of food affect the
      digestion and absorption of lipids has been carried out previously. Studies have shown that
      the release of free fatty acids triggers the fat-related responses. The investigators
      hypothesize that the release of fatty acids depends on the colloidal state of the fat, which
      changes progressively due to the pH changes and enzyme activities in the mouth, stomach and
      intestine.
    


Intervention name(s): administration of fat (sunflower oil), emulsified; Insertion of nasoduodenal tube
Intervention type(s): Dietary Supplement; Procedure
Intervention description(s): 40 ml sunflower oil, in the presence of the emulsifier tween-80.; A nasoduodenal tube is inserted to enable collection of gastric and duodenal aspirates of 2 mL each, to determine gastrointestinal digestion of fat
Other intervention name(s): nasoduodenal intubation; nasoduodenal catheter
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: obesity; fat; appetite; digestion
Impact of CYP3A4*1G Polymorphism on Metabolism of Fentanyl in Chinese Patients Undergoing Lower Abdominal Surgery
Condition: Pain; Surgery
Study type: Observational

Summary: 
      Purpose: This study aimed to investigate the impact of CYP3A4*1G genetic polymorphism on
      metabolism of fentanyl in Chinese patients undergoing lower abdominal surgery. Methods: 176
      patients receiving elective lower abdominal surgery under general anesthesia were recruited
      into this study. Genotyping of CYP3A4*1G was carried out by direct sequencing. The plasma
      fentanyl concentration was detected 30 min after anesthesia induction by high performance
      liquid chromatography-ultraviolet ray (HPLC-UV). The visual analog scale (VAS) was used for
      pain evaluation at rest during patient-controlled analgesia (PCA) treatment 0 h, 12 h and 24
      h after operation. PCA fentanyl consumption and adverse effects were recorded during the
      first 24 h after surgery.
    


Sampling method: Non-Probability Sample
Study population: 
        176 Chinese patients receiving elective lower abdominal surgery under general anesthesia
      
Biospecimen description: 
      176 blood samples were extracted
    
Keywords: gene polymorphism; CYP3A4; fentanyl; HPLC; Analgesics
Effects of Dietary Folate and Phytate Zinc Absorption: Zinc Amino Acid Complexes vs. Zinc-chloride
Condition: Dietary Zinc Absorption
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of consuming a small breakfast of juice
      and toast with added phytate or with taking a folic acid supplement on the absorption of a
      small amount of zinc that is either bound to amino acids or to chloride or picolinate. The
      results of this study will provide new information on how components of diet (e.g., phytate,
      and folic acid) affect the absorption of different forms of dietary zinc (e.g., zinc bound to
      amino acids, zinc chloride, and zinc picolinate).
    


Intervention name(s): Regular toast and juice; High phytate toast and juice; Regular toast and juice, with folic acid
Intervention type(s): Other; Other; Other
Intervention description(s): Participants consume a single test meal composed of regular whole wheat toast and apple juice, and zinc absorption is measured.; Participants consume a single test meal composed of high phytate whole wheat toast and apple juice, and zinc absorption is measured.; Participants consume a single test meal composed of regular whole wheat toast and apple juice, with 400 mcg folic acid; and zinc absorption is measured.
Intervention MeSH terms: Folic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
HeartLight Ablation in Patients With Paroxysmal Atrial Fibrillation (PAF)
Condition: Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the safety and effectiveness of the CardioFocus
      Endoscopic Ablation System with Adaptive Contact (HeartLight) in the treatment of atrial
      fibrillation by creating electrical isolation of the pulmonary veins.
    

Detailed description: 
      A randomized, controlled trial designed to demonstrate the safety and effectiveness of the
      experimental device to deliver pulmonary vein isolation as a treatment for symptomatic atrial
      fibrillation.
    

Intervention name(s): EAS-AC (HeartLight); Control Arm Ablation
Intervention type(s): Device; Procedure
Intervention description(s): Pulmonary vien isolation; Treatment with standard ablation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: atrial fibrillation; AF; PAF; PVI; ablation; paroxysmal atrial fibrillation; pulmonary vein isolation
Flare Prevention Study of Canakinumab in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA)
Condition: Systemic Juvenile Idiopathic Arthritis With Active Flare
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 3

Summary: 
      This two-part study assessed the sustained efficacy of canakinumab in the double-blind Part
      II and the ability to taper steroids in the open label Part I.
    


Intervention name(s): canakinumab; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Canakinumab 4 mg/kg dose subcutaneous injection supplied as 6 mL glass vials each containing 150 mg canakinumab as a lyophilized cake.; Placebo powder matching canakinumab supplied as 6 mL glass vials containing a lyophilized cake for subcutaneous injection every 4 weeks in Part II.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Flare; arthritis; IL-1beta antagonist; systemic juvenile idiopathic arthritis; Juvenile rheumatoid
A Nutrient Cocktail to Protect Against Physical Inactivity
Condition: Metabolic Disturbance; Glucose Intolerance; Physical Inactivity; Glucose Metabolism Disorders; Lipid Metabolism Disorders; Oxidative Stress
MeSH terms: Metabolic Diseases; Glucose Metabolism Disorders; Glucose Intolerance; Lipid Metabolism Disorders
Study type: Interventional

Summary: 
      This experiment consists on a 20-day reduction in daily step in free-living active
      individuals to induce physical inactivity. This will be used to test the efficacy of the
      anti-oxidant cocktail we aim to test as a new countermeasure in 2016 during the 60-d bed rest
      planed by ESA/CNES.

      The objective of this study is to investigate whether the cocktail of natural antioxidants
      XXS-2A comprising vitamin E and coupled with omega-3 helps to prevent and / or reduce the
      glucose intolerance and improve oxidative defenses induced by 20 days of physical inactivity
      through daily step reduction

      Although physical inactivity is reported to affect glucose tolerance within days of
      inactivity, we selected a period of 20 days for the effect of the cocktail to take place and
      assess secondary molecular mechanisms. The effect of this short period of inactivity on
      metabolism will moreover be boosted during the last 10 days by taking fructose, a sugar found
      in abundance in fruits, honey and juices, which is known to quickly trigger metabolic
      deregulation.
    


Intervention name(s): XXS-2A + Omega-3 + Vitamin E + Selenium; control diet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Micronutrient cocktail supplementation with 560,7 mg/ day of polyphenols (3 pills/day), 2,1 g/day of omega-3 fatty-acids (3 pills/day), 168 mg/day of vitamin E and 80µg/day of selenium (1 pill/day); habitual diet to be followed
Intervention MeSH terms: Vitamin E; Selenium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Metabolism; Lipid oxidation; micronutrient cocktail supplementation; physical inactivity; glucose intolerance; oxidative stress
The Effects of Bifidobacterium Breve Bif195 for Diarrhea-predominant Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional

Summary: 
      The purpose of this study is to investigate if the probiotic Bifidobacterium breve Bif195
      (Bif195) will result in improvement in clinical outcome in patients with diarrhea-predominant
      irritable bowel syndrome (IBS).
    

Detailed description: 
      IBS is the most frequently diagnosed gastrointestinal disease and also the most common cause
      of referrals to gastroenterology departments in Denmark.

      The possibilities for treatment for IBS are limited. Treatment strategies that involve the
      microbiota provide symptom relief in some IBS patients. Several studies have demonstrated
      that the composition of the gut microbiota in IBS patients is different from healthy
      controls.

      Probiotic interventions has shown promising results, but it currently remains unknown which
      probiotics are effective and which are not.

      A new probiotic bacterium, Bifidobacterium breve Bif195 (Bif195) has been identified and has
      shown great effects on preventing enteropathy and ulcers on the gut mucosa in healthy
      volunteers given acetylsalicylic acid, and thereby Bif195 has also shown a potential in
      reducing gut permeability defects. This bacterium has not yet been investigated in IBS
      patients.
    

Intervention name(s): Bifidobacterium breve Bif195; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1 capsule daily for 8 weeks; 1 capsule daily for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Probiotics