bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate Safety of Three Intra-articular Injections of Ampion in the Knee of Adults With Osteoarthritis Pain
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Phase 1 will evaluate the safety of 3 intra-articular injections of Ampion™ administered 2
      weeks apart to adults with osteoarthritis of the knee.

      In the absence of serious drug-related Adverse Events (AEs) of unanticipated drug-related
      AEs, enrollment will be initiated in Phase 2 of the study.

      Phase 2 will evaluate the efficacy of 3 intra-articular injections, given 2 weeks apart, of
      Ampion™ in Adults with pain due to osteoarthritis of the knee.
    

Detailed description: 
      Phase 1: An open-label study to evaluate the safety of 3 intra-articular injections of of
      Ampion™ 4 mL at Baseline (Day 0) and Weeks 2 and 4 to adults with osteoarthritis (OA) knee
      pain. Enrollment will be initiated in Phase 2 if no serious drug-related adverse events or
      unanticipated drug-related adverse events are observed.

      Phase 2: A randomized, placebo-controlled, double-blind, study to evaluate the safety and
      efficacy of 3 intra-articular (IA) injections of Ampion™ 4 mL at Baseline (Day 0) and Weeks 2
      and 4 in adults with OA knee pain.

      Study Objectives

      Phase 1:

      To evaluate the safety of Ampion™ 4 mL administered as 3 intra-articular injections, two
      weeks apart, in subjects suffering from OA of the knee from Baseline to Week 20.

      Phase 2:

      The primary study objective is to evaluate the safety and efficacy of Ampion™ 4 mL versus
      placebo injection from Baseline to Week 20, when administered as three intra-articular (IA)
      injections (at Baseline (Day 0) and Weeks 2 and 4), in improving knee pain in subjects
      suffering from OA of the knee.
    

Intervention name(s): 4 mL injection of Ampion; 4 mL injection of Placebo
Intervention type(s): Biological; Drug
Intervention description(s): 4 mL injection of Ampion
Other intervention name(s): Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Osteoarthritis; osteoarthritis of the knee
Effects of Different Levels of Physical Activity on Postoperative Pulmonary Complications in Patients Undergoing Thoracoscopic Lung Resection Surgery Under General Anesthesia
Condition: Postoperative Pulmonary Complications
Study type: Observational

Summary: 
      Due to the special operation location and the obvious characteristics of ventilator-related
      lung injury during anesthesia in lung resection surgery, the incidence of postoperative
      pulmonary complications is higher than that of other surgeries, and it is one of the
      important factors affecting the postoperative outcomes of patients. Previous studies have
      shown that reaching a certain level of activity or continuing regular exercise can reduce or
      prevent postoperative pulmonary complications without taking drugs. Therefore, the
      researchers designed this study to explore the influence of different levels of physical
      activity on postoperative lung complications after thoracoscopic lung resection surgery under
      general anesthesia, which has important clinical guiding significance for preoperative
      comprehensive assessment of patients' lung function, screening of fragile lungs and
      intraoperative lung protective ventilation strategy.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients aged 18~80 years undergoing elective thoracoscopic lung resection surgery under
        general anesthesia
      
Biospecimen description: 
      Arterial blood samples from patients
    
Keywords: Postoperative pulmonary complications; lung resection surgery; Physical activity; General anesthesia
Repeated Dose Study for the Investigation of Heritability of and Genetic Influences on Drug Pharmacokinetics
Condition: Drug Biotransformation; Membrane Transport
Study type: Interventional
Phase: Phase 1

Summary: 
      This human pharmacokinetic study investigates, whether processes of drug metabolism and
      transport are determined by genetic or hereditary factors. Therefore, approved drugs are
      applied to twins and metabolism and transport processes are investigated.
    


Intervention name(s): Codeine; Midazolam; Pravastatin; Torsemide; Talinolol; Caffeine; Metoprolol
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Treatment period 2:
5 mg Codeine once; Treatment period 1:
0.2 mg Midazolam 3x
Treatment period 2:
1 mg Midazolam once; Treatment period 2:
5 mg Pravastatin once; Treatment period 1:
2.5 mg Torsemide 3x
Treatment period 2:
0.25 mg Torsemide once; Treatment period 1:
50 mg Talinolol 3x
Treatment period 2:
2.5 mg Talinolol once; Treatment period 1:
50 mg Caffeine 3x; Treatment period 1:
5 mg Metoprolol 3x
Intervention MeSH terms: Metoprolol; Talinolol; Torsemide; Midazolam; Codeine; Caffeine; Pravastatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pharmacokinetic; heritability; drug membrane transport; drug biotransformation
Stereotactic Body Radiation Therapy (SBRT) for Patients With Hepatic Metastases
Condition: Liver Metastases
MeSH terms: Neoplasm Metastasis
Study type: Interventional
Phase: Phase 1

Summary: 
      Patients that have had staging studies identifying them as AJCC stage IV with up to five
      liver metastases will be considered for the study. About 60 patients will take part in this
      study at UT southwestern, Parkland Health & Hospital System, and Methodist Richardson Cancer
      Center. There are four dose cohorts for this study and each cohort will enroll a minimum of 7
      to a maximum of 15 patients depending on tolerance of therapy. The treatment period will last
      for approximately 1 day and the follow-up portion of the study will last 5 years.
    

Detailed description: 
      If the patient has met all the eligibility criteria, they will be registered to the study
      After successful registration to the study and treatment planning session, patients will
      receive a single fraction of radiation. The total dose a particular patient receives will
      depend on the dose cohort they are enrolled into. Each treatment will last about one hour and
      will be given in a particular position to help guide the beams of radiation toward the cancer
      area. Although it is not mandatory, it is recommended that patients receive corticosteroid
      premedication (e.g. Decadron 4-10 m.g. p.o. in a single dose or equivalent) 15-60 minutes
      prior to each treatment for the intended purpose of modulating immediate acute inflammatory
      effects and providing anti-emetic support.
    

Intervention name(s): SBRT
Intervention type(s): Radiation
Intervention description(s): Single fraction SBRT
Other intervention name(s): Stereotactic Body Radiation Therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: liver metastases; Stereotactic Body Radiation Therapy
MEDI4736 (Anti PD-L1) Combined With Gefitinib in Subjects With Non-Small Cell Lung Cancer(NSCLC).
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      This a Phase I, Open-Label, Multicentre Study to assess the safety, tolerability,
      pharmacokinetics and preliminary anti-tumour activity of gefitinib in combination with
      MEDI4736 (anti PD-L1) in Subjects with Non-small cell lung cancer (NSCLC). The study consists
      of two phases: Escalation phase and an expansion phase to be conducted in locally advanced or
      metastatic NSCLC subjects
    

Detailed description: 
      In Escalation phase: MEDI4736 and gefitinib in NSCLC subjects In Expansion phase: Subjects
      with EGFR mutation positive locally advanced or metastatic NSCLC will be enrolled in
      expansion arms. Initiation of expansion arms with the recommended dose of MEDI4736 in
      combination with gefitinib will be based on an adequate safety and tolerability profile of
      the combination from the escalation phase.
    

Intervention name(s): Gefitinib; MEDI4736
Intervention type(s): Drug; Drug
Intervention description(s): Gefitinib QD; MEDI4736 IV Q2W
Intervention MeSH terms: Durvalumab; Gefitinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NSCLC
Effects of Onion Peel Extract on Endothelial Function
Condition: Healthy; Overweight; Obese
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 4

Summary: 
      Acute or chronic intake of polyphenol-rich foods has been reported to improve endothelial
      function. Quercetin, found abundantly in onion, is a potent antioxidant flavonoid. This study
      was designed to investigate whether consumption of onion peel extract (OPE) improves
      endothelial function in healthy overweight and obese subjects.
    

Detailed description: 
      Epidemiological studies have shown a rapid increase in the prevalence of overweight and
      obesity, not only in adults but also in children and adolescents, thus increasing the risk of
      early development of cardiovascular disease (CVD). Quercetin, found abundantly in onion,
      prevents the induction of endothelial dysfunction, superoxide production, and overexpression
      by angiotensin II in the rat aorta. Furthermore, in our previous study we showed that
      supplementation with quercetin-rich onion peel extract (OPE) influenced adipokine expression,
      thus addressing its modulatory effect on obesity-induced inflammation, and improved insulin
      resistance by alleviating the metabolic dysregulation of free fatty acids, suppressing
      oxidative stress, upregulating glucose uptake, and downregulating inflammatory gene
      expression. But there are limited studies on the relationship between quercetin
      supplementation and endothelial dysfunction in humans.
    

Intervention name(s): Placebo; Onion peel extract
Intervention type(s): Drug; Drug
Intervention description(s): After randomization, placebo was treated for 12 weeks; After randomization, onion peel extract was treated for 12 weeks
Other intervention name(s): OPE
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Quercetin; Endothelial function; Onion peel extract; volunteers
A Study of Erythromycin and Rivaroxaban in Study Participants With Normal and Reduced Kidney Function
Condition: Healthy; Renal Insufficiency
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamics of
      rivaroxaban when administered with erythromycin to study participants with mild or moderate
      renal impairment compared to the pharmacokinetics and pharmacodynamics of rivaroxaban
      administered to study participants with normal renal function.
    

Detailed description: 
      This is an open-label study (participants and the study physician [Investigator] will know
      the identity of the assigned treatments) to compare the pharmacokinetics (PK) (how the drugs
      are absorbed in the body) and pharmacodynamics (PD) (the actions or effects of drugs on the
      body) of rivaroxaban in study participants with mild or moderate renal impairment (reduced
      kidney function) receiving multiple doses of erythromycin, to the PK and PD of a single dose
      of rivaroxaban administered alone in study participants with normal renal function. The study
      drugs used will be rivaroxaban, a drug that acts to thin the blood to prevent the formation
      of blood clots, and erythromycin, an antibiotic used to treat patients with bacterial
      infections. Study participants with normal renal function will receive Treatment A (1 oral
      [by mouth] dose 10 mg rivaroxaban for 1 day) and Treatment C (500 mg oral erythromycin 3x a
      day (t.i.d.) on Days 1-6 + 1 oral dose of 10 mg rivaroxaban on Day 5). Study participants
      with mild and moderate renal impairment will receive Treatment A, Treatment B (500 mg oral
      erythromycin t.i.d. on Days 1-6 + 1 oral dose of 5 mg rivaroxaban Day 5), and Treatment C.
      Treatments A, B, and C will be separated by up to 14 days.
    

Intervention name(s): Rivaroxaban (normal renal function); Rivaroxaban (mild and moderate renal impairment); Erythromycin (normal renal function); Erythromycin (mild and moderate renal function)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): One 10 mg tablet of rivaroxaban taken orally (by mouth) on Day 1 of Treatment Period 1; One 10 mg tablet of rivaroxaban taken orally on Day 5 of Treatment Period 2; One 10 mg tablet of rivaroxaban taken orally (by mouth) on Day 1 of Treatment Period 1; One 5 mg tablet of rivaroxaban taken orally on Day 5 of Treatment Period 2; One 10 mg tablet of rivaroxaban taken orally on Day 5 of Treatment Period 3; One 500 mg tablet taken orally (by mouth) three times daily on Days 1 to 6 of Treatment Period 2; One 500 mg tablet taken orally (by mouth) three times daily on Days 1 to 6 of Treatment Periods 2 and 3
Intervention MeSH terms: Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate; Rivaroxaban
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Renal Insufficiency; Rivaroxaban (BAY 59-7939, JNJ-39039039); Erythromycin; Pharmacokinetic; Pharmacodynamic
Bringing Awareness Into Eating
Condition: Stress Eating; Reward-based Eating; Craving-related Eating
Study type: Interventional

Summary: 
      The purpose of this study is to test an app-based mindful eating intervention to decrease the
      reward value of unhealthy food.
    

Detailed description: 
      Eating healthily is highly beneficial. However, changing eating habits is notoriously
      difficult. Individuals often believe that they simply need to "restrain" their eating
      impulses in order to eat more healthily. However, such an approach has not only been shown to
      be quite ineffective over long time spans, it is also associated with aversive feelings: It
      simply does not feel good to struggle with one's own impulses.

      Investigators are testing a new approach to overcoming unhealthy eating habits, which
      utilizes mindful eating to change the reward value of unhealthy food. The hypothesis is that
      if people pay attention to how unhealthy food (e.g. "junk" food) makes them feel in their
      bodies, their liking it and desire to eat it will decrease naturally. Participants might
      become aware, for example, that eating a whole bag of chips leads to nausea, while eating a
      salad makes them feel fresh and energetic.

      Investigators will assess whether and how the anticipated and actual satisfaction associated
      with unhealthy food will decrease the more often participants use this intervention.
    

Intervention name(s): App-based mindful eating
Intervention type(s): Behavioral
Intervention description(s): This is a mindful eating smartphone application comprised of twenty-eight modules of 10-15 minutes each designed to teach mindfulness for binge eating. The feature that is being tested will ask individuals to do a mental exercise when they're craving and will measure their satisfaction related to the experience.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Grape Pomace Polyphenols and Cardiometabolic Risk
Condition: Subjects at Cardiometabolic Risk
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      The aim of this is study is to evaluate the long-term effects of grape polyphenols in the
      modulation of markers of metabolic syndrome. Most of the previous works about polyphenols
      have only considered a fraction of polyphenols, i.e., extractable polyphenols. As a
      consequence, an important amount of dietary polyphenols, the so-called non-extractable
      polyphenols are ignored. In contrast, the effect of both extractable and non-extractable
      polyphenols will be considered in this study. Also, studies on the long-term effect of grape
      polyphenol on markers of metabolic syndrome have been mostly conducted in animals, so
      clinical trials on this topic are needed.
    

Detailed description: 
      Fifty supposedly healthy volunteers with at least two cardiometabolic risk factors were
      recruited. The cardiometabolic risk factors used to select the subjects are described below.

      The whole intervention will be divided in 2 periods, control (CTR) and dried and milled grape
      pomace (GRAPOM). The two periods will have a duration of 6 weeks. During the CTR period,
      subjects will follow their normal dietary habits and samples will be collected at the
      beginning and at the end. No proper placebo could be found for the product, so this CTR
      period was chosen. During the GRAPOM period, the subjects will daily consume 8 g of the
      product solved in water and samples will be collected at the beginning and at the end.
    

Intervention name(s): GRAPOM
Intervention type(s): Dietary Supplement
Intervention description(s): The whole intervention will be divided in 2 periods, control (CTR) and dried and milled grape pomace (GRAPOM). The two periods will have a duration of 6 weeks. During the CTR period, subjects will follow their normal dietary habits and samples will be collected at the beginning and at the end. No proper placebo could be found for the product, so this CTR period was chosen. During the GRAPOM period, the subjects will daily consume 8 g of the product solved in water and samples will be collected at the beginning and at the end.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: GRAPOM: dried and milled grape pomaces. CTR: control period. All the subjects will pass the two periods: one half will do the CTRL period followed by the GRAPOM period, and the other half will do it inversely. The assignment to each order will be done randomly. Both period will be separated by a four weeks washing period.
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Polyphenols; Metabolic syndrome; Cardiometabolic risk; Grape pomace; Postprandial glucose; Insulin resistance; Obesity
Iron Sucrose in Non-Dialysis Dependent (NDD-CKD) Pediatric Patients
Condition: Anemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to assess the pharmacokinetics of Venofer (Iron
      Sucrose Injection) in NDD-CKD pediatric patients.
    


Intervention name(s): Venofer
Intervention type(s): Drug
Intervention description(s): Single dose of 7mg intravenous (IV) of iron per kg of body weight for a maximum of 200mg iron IV.
Intervention MeSH terms: Ferric Oxide, Saccharated
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Assess the Effect of Salbutamol and Ipratropium Bromide in Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: COPD
Study type: Interventional
Phase: Phase 4

Summary: 
      The objectives of this study are to assess the effect of salbutamol in comparison with
      ipratropium bromide on the geometry of central and peripheral airways and to correlate
      spirometric indices with the Computational Fluid Dynamics (CFD) based calculated airway
      volumes and resistances for both compounds.
    

Detailed description: 
      Salbutamol (VentolinTM) is a short acting beta agonist (SABA) which is used to treat
      wheezing, dyspnea and breathing difficulties caused by asthma and COPD. Further, it is also
      used to prevent bronchospasm during exercise.

      Ipratropium bromide (Atrovent® HFA) is a short acting anticholinergic bronchodilator (short
      acting muscarinic antagonist (SAMA)) that improves lung function, dyspnea, exercise tolerance
      and health-related quality of life in patients with COPD. Studies have also shown that
      ipratropium bromide might reduce COPD exacerbations and related hospitalisations because the
      extended bronchodilatation might reduce infection rates by improving clearance of respiratory
      secretions.

      In this open, randomized, two-way crossover, pilot study the effect of salbutamol in patients
      with moderate and severe COPD will be examined in comparison with the effects of ipratropium
      bromide. These patients will receive 400 µg salbutamol and 80 µg ipratropium bromide in a
      randomized crossover design.

      The objectives of this study are to assess the effect of salbutamol in comparison with
      ipratropium bromide on the geometry of central and peripheral airways and to correlate
      spirometric indices (as Forced Expiratory Volume in one second (FEV1) and Tiffeneau index)
      with the Computational Fluid Dynamics (CFD) based calculated airway volumes and resistances
      for both compounds.
    

Intervention name(s): Salbutamol; ipratropium bromide
Intervention type(s): Drug; Drug
Intervention description(s): 400 µg inhalation once; 80 µg inhalation once
Other intervention name(s): Ventolin; atrovent
Intervention MeSH terms: Bromides; Albuterol; Ipratropium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD; salbutamol; ipratropium bromide; computational fluid dynamics; functional imaging; central and peripheral airways
mDiet - Ecological Momentary Intervention of Diet Via Mobile Technology
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This is a NCI funded study which will develop and evaluate a cell phone application (mDIET)
      that can be used as an assessment and intervention tool to improve dietary behaviors and thus
      reduce weight in overweight and moderately obese (BMI 25-34.9) men and women ages 25-55.
    

Detailed description: 
      This research will develop a technologically advanced system for monitoring and intervening
      on diet behaviors (e.g., food intake, weight). Interventions aimed at dietary change are
      missing a comparable, portable tool. Mobile technologies can help fill this gap by providing
      portable connectivity to expert systems that create specific tailored diet goals based on
      participant profiles. The expert system can 'push' intervention messages throughout the day
      during critical point-of-decision moments to aid in decision making among users. The portable
      device can 'pull' information through prompts and easy-to-use recording. This ecological
      momentary assessment + ecological momentary intervention format may further encourage healthy
      behaviors by prompting at critical decision points to improve dietary behaviors.
    

Intervention name(s): Printed Material; Weekly Weighing; Cell phone will serve as a self monitoring device; Text Message; Diet Goals via Cell Phone; Food Monitoring
Intervention type(s): Behavioral; Behavioral; Behavioral; Device; Behavioral; Behavioral
Intervention description(s): Printed Material; Weekly Weighing; Cell phone will serve as a self monitoring device; Text Message; Diet Goals via Cell Phone; Food Monitoring
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Overweight; Cell Phone; Technology