bioihbjkbjnl/mcl2 huggingface dataset:
Phase II Trial of Sequential Consolidation With Pembrolizumab Followed by Nab-paclitaxel
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to test the effectiveness of three treatment arms that
      are designed to improve survival in patients with non-small cell lung cancer. Eligible
      subjects could be randomized to four (4) cycles of chemotherapy followed by immunotherapy, or
      immunotherapy followed by chemotherapy, or four cycles of chemotherapy plus immunotherapy.
    

Detailed description: 
      This open-label, three-arm, non-comparative randomized phase II study is designed to evaluate
      three different sequences of double-consolidation with the humanized monoclonal antibody
      targeted against cell surface receptor programmed cell death-1 (PD-1), pembrolizumab, and
      nab-paclitaxel in patients with advanced Non small cell lung cancer post induction
      chemotherapy. While the goal of each arm is to guarantee exposure to each of these two agents
      to patients who have not progressed post induction chemotherapy, they do so with different
      sequence. In ARMs A and B, consolidation is sequential, with either pembrolizumab followed by
      nab-paclitaxel (ARM A), or nab-paclitaxel followed by pembrolizumab (ARM B). In ARM C,
      consolidation is concurrent, with the two agents administered concurrently. As of July 24,
      ARMs B and C are closed, and no patients will be enrolled on this study. ARM A remains open
      to enrollment.
    

Intervention name(s): Pembrolizumab
Intervention type(s): Drug
Intervention description(s): Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles.
Other intervention name(s): Keytruda; nab-paclitaxel
Intervention MeSH terms: Paclitaxel; Pembrolizumab
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lung cancer; PD-1 antibody; immune checkpoint blockade
Pharmacokinetic Interaction Study to Assess the Effect of Repeat Doses of Rifampin on Mirabegron (YM178) in Healthy Volunteers
Condition: Pharmacokinetics of YM178
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to assess the PK, safety and tolerability of a single dose of
      mirabegron alone and in combination with repeat doses of rifampin, a potent CYP3A4 inducer.
    

Detailed description: 
      A single group of patients will receive both mirabegron alone and in combination with
      rifampin
    

Intervention name(s): mirabegron; rifampin
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): YM178; Rifadin
Intervention MeSH terms: Rifampin; Mirabegron
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Healthy volunteer subjects; CYP3A4 inducer; rifampin; drug interaction; pharmacokinetics; YM178; mirabegron
Treatment of Granuloma Umbilical in Newborn Babies
Condition: Fetus or Newborn Affected by Condition of Umbilical Cord
MeSH terms: Granuloma
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators want to show that steroid creme and even better alcohol swaps are just as
      effective or equal to the current treatment with silver nitrate of granuloma umbilical in
      newborns.
    

Detailed description: 
      The change of treatment will make it possible for parents to treat the children themselves at
      home, whereas treatment with silver nitrate only is an in hospital regimen.
    

Intervention name(s): silver nitrate; Steroids; alcohol
Intervention type(s): Procedure; Drug; Procedure
Intervention description(s): Application 1 - 2 times a week for 3 - 4 weeks; Dermovate creme group IV steroid. Application 2 times a day for 3 weeks or less if the granuloma disappears.; Alcohol swabs 82% ethanol. Application 6 - 8 times a day, each time the parents change the diaper. Treatment for 3 weeks or less if the granuloma disappears.
Other intervention name(s): Product ATC code D08AL01; Clobetasolpropionat 0,5 mg/g; ATC kode D07AD01; 82% ethanol
Intervention MeSH terms: Ethanol; Silver Nitrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: granuloma umbilical
AXIOS Stent With Electrocautery Enhanced Delivery System
Condition: Pancreatic Pseudocyst(s)
MeSH terms: Pancreatic Pseudocyst
Study type: Interventional

Summary: 
      The purpose of this study is to demonstrate the safety and effectiveness of the AXIOS Stent
      with Electrocautery Enhanced Delivery System for endoscopic transenteric drainage of
      pancreatic pseudocysts.
    


Intervention name(s): AXIOS Stent with Electrocautery Enhanced Delivery System
Intervention type(s): Device
Intervention description(s): Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pancreatic pseudocyst
The Snack Study: The Feasibility of Changing Night-time Food Choices to Improve Glucose Tolerance in Pregnancy
Condition: Glucose Intolerance; Obesity
MeSH terms: Glucose Intolerance
Study type: Interventional

Summary: 
      Obesity during pregnancy increases the risk for high glucose and diabetes in the mother, and
      for obesity and comorbid metabolic disease in the offspring. Results of previous intervention
      studies designed to improve the metabolic health of obese mothers, and thereby reduce the
      risk to their offspring, have been modest at best. Furthermore, few studies have proved to be
      efficacious among low income African American women who have high risk for the transmission
      of obesity to future generations. The purpose of this study is to examine the feasibility of
      changing the types of foods and drinks that are consumed at night during late pregnancy in
      order to improve maternal glucose tolerance and reduce the risk for future obesity in the
      child.
    

Detailed description: 
      Obesity during pregnancy increases the risk for high glucose and diabetes in the mother, and
      for obesity and comorbid metabolic disease in the offspring. Results of previous intervention
      studies designed to improve the metabolic health of obese mothers, and thereby reduce the
      risk to their offspring, have been modest at best. Furthermore, few studies have proved to be
      efficacious among low income African American women who have high risk for the transmission
      of obesity to future generations. The purpose of this study is to examine the feasibility of
      changing the types of foods and drinks that are consumed at night during late pregnancy in
      order to improve maternal glucose tolerance and reduce the risk for future obesity in the
      child. We hypothesize that women who replace their usual night-time foods and drinks with
      lower glycemic load options will have more stable night-time glucose and lower glucose
      following an oral glucose load. This intervention will be assessed in a cohort of African
      American women of low income, who were obese at their first prenatal care visit.
    

Intervention name(s): Low glycemic load snacks
Intervention type(s): Behavioral
Intervention description(s): Intervention to replace standard night-time food and drinks with lower glycemic load options
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: nutrition
Looking Beyond the Immediate Effects of Lumbar Spinal Manipulation Using Pain Pressure Threshold in Asymptomatic Individuals
Condition: Lumbar Spine Injury; Pain
MeSH terms: Spinal Injuries
Study type: Interventional

Summary: 
      The goal of this clinical trial is to test in the effects of pain pressure threshold (PPT)
      looking out to 30 minutes in the lumbar spine. The main question[s] it aims to answer are:

      • Is there a difference between PPT from baseline, immediately after, or 30 minutes after
      compared to sham ultrasound control group? Participants will be exposed to sham ultrasound or
      sidelying lumbar manipulation with between groups and within group comparisons of PPT at the
      posterior superior iliac spine up to 30 minutes following the intervention.
    


Intervention name(s): Sidelying lumbar manipulation
Intervention type(s): Procedure
Intervention description(s): R sided lumbar manipulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Examining the Relationship Between Acute Meal Intake and Inflammation in Children
Condition: Obesity; Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      Recent evidence has shown that obese and overweight children exhibit states of chronic
      inflammation. In obese adults, a high carbohydrate meal induces an inflammatory response;
      however, the effects of a high carbohydrate meal on biomarkers of inflammation has not
      previously been examined in children. The purpose of this research project is to characterize
      the inflammatory response to a high carbohydrate versus a low carbohydrate meal in healthy
      weight, overweight, and obese children (age 7-17 years). After completing informed
      consent/assent, a Dual-energy X-ray Absorptiometry (DXA) scan, and baseline blood draw on
      experimental day 1, children will then return to the lab two times to ingest either a high or
      low carbohydrate beverage followed by post-meal blood collection for a total of 3 blood
      draws. Biomarkers of inflammation will be analyzed by flow cytometry and enzyme-linked
      immunosorbent assay (ELISA). Participants will be recruited through various studies through
      the Neurocognitive Kinesiology Lab/Body Composition and Nutritional Neuroscience Labs as well
      as through the local Champaign-Urbana community. Data from this project will provide a better
      understanding of the inflammatory response to different meals in healthy weight, overweight,
      and obese children.
    


Intervention name(s): Eggs and Carbohydrates
Intervention type(s): Other
Intervention description(s): Participants are asked to consume both egg based powder or maltodextrin dissolved in 500mL of water at two different time points at least one week apart. Participants will then submit to a venous blood draw to assess levels of cellular inflammation.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double blind randomized cross-over design
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Children; Inflammation; Obesity
Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (4 to 15 y) (BY9010/M1-205)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate
      on lung function, symptoms, and use of rescue medication in children with persistent asthma.
      Ciclesonide will be inhaled at one dose level once daily; fluticasone propionate will be
      inhaled at one dose level twice daily. The study duration consists of a baseline period (2 to
      4 weeks) and a treatment period (12 weeks). The study will provide further data on safety and
      tolerability of ciclesonide.
    


Intervention name(s): Ciclesonide
Intervention type(s): Drug
Intervention MeSH terms: Ciclesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Asthma; Ciclesonide; Child; Fluticasone propionate; Pediatric
Evaluation of the Evolution of Biological and Imaging Markers of Bone and Cartilage Degradation in Patients With Knee Osteoarthritis Receiving Intra-articular Injections of a Hyaluronan Derivative HYMOVIS®
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This pilot study MOKHA is aimed to evaluate the beneficial effect of HYMOVIS® on cartilage of
      patients suffering of knee osteoarthritis as revealed by using scientifically sound,
      objective measurements of biological and MRI-based imaging markers.
    

Detailed description: 
      This study is a post-marketing, open-label, prospective and multicentric pilot study in 50
      patients suffering from knee OA. Investigators will be rheumatologists or articular disease
      specialists from public or academic hospitals located in Belgium and France. In each
      investigating center, the same injector will perform all the VS.
    

Intervention name(s): HYMOVIS
Intervention type(s): Device
Intervention description(s): HYMOVIS is a clear hydrogel obtained by hydration of the HA-based derivative named HYADD4p5. The conjugate compound is constituted by a partial hexadecylamide of hyaluronic acid, which is produced by a fermentation process.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hyaluronic acid; MRI; Biomarkers; Cartilage; pain
Evaluation of the Safety and Pharmacology of EYP001 in HBV Subjects
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis B; Hepatitis B, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      Bile acids regulating farnesoid X receptor (FXR) interact with hepatitis B virus replication.
      EYP001a is a selective, synthetic FXR agonist under development for the treatment of
      hepatitis B.

      This Phase 1b study is designed primarily to determine the safety, tolerability,
      pharmacokinetics and pharmacodynamics of EYP001a in chronically HBV infected subjects.
    

Detailed description: 
      This is a multicenter, randomized, double-blind, placebo-controlled two-part trial.

      In Part A, EYP001a will be administered as 29 days monotherapy. Three dose-levels and 2
      dosing regimens of EYP001a will be explored against placebo. The design also includes an
      open-label standard of care Entecavir monotherapy arm (comparator). Subjects will be randomly
      assigned to one of the 6 treatment arms:

        -  Treatment A: oral EYP001a

        -  Treatment B: oral EYP001a

        -  Treatment C: oral EYP001a

        -  Treatment D: oral EYP001a

        -  Treatment E: oral placebo

        -  Treatment F: oral Entecavir

      In Part B, EYP001a or placebo will be administered as 29 days combination therapy with the
      standard of care Peg-IFNα2a. Subjects will be randomly assigned to one of the 3 treatment
      arms:

        -  Treatment G: oral EYP001a plus open label Peg-INFα2a administered as subcutaneous
           injection

        -  Treatment H: oral EYP001a plus open label Peg-INFα2a administered as subcutaneous
           injection

        -  Treatment I: oral placebo plus open label Peg-INFα2a administered as subcutaneous
           injection

      Subjects enrolled in Part A are eligible for participation in Part B.

      Participation will include a 40 day screening period, a 29 day treatment period and a 6 day
      follow-up evaluation period. For subjects who participate in both Parts A and B, a 14 washout
      period between Parts A and B will be included.

      The safety and tolerability of EYP001a will be assessed by evaluating physical examinations,
      vital signs, ECGs, clinical laboratory parameters, and adverse events.
    

Intervention name(s): EYP001a; Placebo; Entecavir; peg-interferon alfa-2a
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Capsules administered orally. Number of morning and evening capsules depending on treatment arm; Placebo capsules for oral administration, identical in appearance to the EYP001a capsules; Tablets administered orally; Ready-to-Use pre-filled syringes for subcutaneous injection
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Entecavir; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Early Phase Pre-Clinical and Initial Clinical Research on Epicatechin (Part 2)
Condition: Pre-diabetes
MeSH terms: Prediabetic State; Glucose Intolerance
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a double-blind, randomized, placebo-controlled, single dose study of (+)-
      epicatechin with one 30mg dose/day for a total of 7 days
    

Detailed description: 
      This project is a double-blinded, placebo-controlled, randomized, Phase I study that will
      include (+)-epicatechin dosing over seven days.

        -  Subjects will meet the American Diabetes Association (ADA) criteria for pre-diabetes,
           including impaired fasting glucose (IFG) [refer to inclusion/exclusion criteria].

        -  The Project includes: 7 day evaluation of a single daily dose of synthetic
           (+)-epicatechin in pre-diabetic individuals as compared to placebo.

        -  The Project has 4 outpatient clinic study visits: screening (Visit 1), randomization
           (Visit 2), end of study drug (Visit 3), follow up end of study (Visit 4).

        -  This Project has 2 telephone visits

      Primary hypothesis: As these studies are designed to evaluate safety and tolerability, there
      is no primary hypothesis to test.

      Primary outcome measures. Vital signs and safety labs: BP, HR, creatinine, alkaline
      phosphatase, and liver transaminases

      These studies will provide initial data about if (+)-epicatechin can influence glycemic
      control in individuals with prediabetes.
    

Intervention name(s): epicatechin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 30 mg (+)-epicatechin, taken orally, one pill/day in the morning; Placebo pill, taken orally, one pill/day in the morning
Other intervention name(s): 122158
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: epicatechin; pre-diabetes
Effect of InFat™ Product on Stool Biochemistry and Stool Characteristics in Formula-fed Term Infants in China
Condition: Health Behavior; Personal Satisfaction
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of infant formula with high percentage
      of palmitic acid at the sn-2 position (InFat™) on improving fat absorption and general
      gastrointestinal tolerance in Chinese formula-fed term infants.
    

Detailed description: 
      The purpose of this study is to assess the efficacy of infant formula with high percentage of
      palmitic acid at the sn-2 position (InFat™) as compared to standard vegetable oil based
      infant formula on general gastrointestinal tolerance and fat absorption, reducing calcium
      soaps formation and stool hardness in Chinese formula-fed term infants.
    

Intervention name(s): InFat™ based infant formula; Standard vegetable oil based infant formula
Intervention type(s): Other; Other
Intervention description(s): high sn-2 palmitic acid oil based infant formula; standard vegetable oil based infant formula
Other intervention name(s): high sn-2 palmitic acid; structured triglyceride; standard vegetable oil
Intervention MeSH terms: Palmitic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
A Study Evaluating Sitamaquine Compared With Amphotericin B In The Treatment Of Visceral Leishmaniasis.
Condition: Leishmaniasis, Visceral
MeSH terms: Leishmaniasis; Leishmaniasis, Visceral
Study type: Interventional
Phase: Phase 2

Summary: 
      Sitamaquine is an 8-aminoquinoline which is being developed as an oral treatment for visceral
      leishmaniasis (VL). Pre-clinical and subsequent clinical investigations have demonstrated
      oral efficacy against Leishmania donovani. The purposes of this study are to characterise the
      pharmacokinetic profile of sitamaquine, administered orally, and to determine if the
      pharmacokinetic profile is affected by administration with food. The study is also designed
      to further characterise the safety and tolerability of sitamaquine compared with amphotericin
      B, particularly in reference to renal, hepatic and cardiac adverse events, prior to
      initiation of phase III studies. Finally the study will investigate the efficacy of a 21 day
      treatment course. Previous studies have used 28 days dosing, but parasitological evidence
      from one study suggests that shorter courses may be effective.
    


Intervention name(s): sitamaquine
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: amphotericin B; safety; tolerability and pharmacokinetics of oral sitamaquine; Visceral leishmaniasis
Dietary Fibre and Metabolic Benefits
Condition: Glucose Tolerance
Study type: Interventional

Summary: 
      The aim of the project is to study the connection between bacterial fermentation in the colon
      of prebiotic substrates and effects on systemic metabolism and appetite i healthy humans
    

Detailed description: 
      The purpose with this project is to study the association between bacterial fermentation in
      the colon of specific mixtures of cereal dietary fiber and effects on systemic metabolism and
      appetite regulation. For this purpose, short term studies are performed in healthy adult
      subjects. Different cereals, cereal blends and from cereal extracted dietary fiber will be
      studied, as well as effects of different processing of the cereals. Cardiometabolic test
      markers and colonic fermentation metabolites will be followed up to 14 h after intake of the
      test substrates, and gut microbiota composition will be determined prior to and after the
      interventions.
    

Intervention name(s): Cereal product 1; Cereal product 2; Cereal product 3; Cereal product 4; Cereal product 5; Control product
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Cereal products based on rye, barley, wheat, oat, and corn; Cereal products based on rye, barley, wheat, oat, and corn; Cereal products based on rye, barley, wheat, oat, and corn; Cereal products based on rye, barley, wheat, oat, and corn; Cereal products based on rye, barley, wheat, oat, and corn; A cereal based product with low concentrations of df
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover randomised
Masking: Single (Participant)
Primary purpose: Prevention