bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Cabazitaxel in Pediatric Patients With Refractory Solid Tumors Including Central Nervous System Tumors
Condition: Malignant Solid Tumor - Malignant Nervous System Neoplasm
MeSH terms: Nervous System Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Primary Objectives:

      Phase 1 Part:

      To determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) of
      cabazitaxel as a single agent in pediatric participants with recurrent or refractory solid
      tumors including tumors of the central nervous system.

      Phase 2 Part:

      To determine the objective response rate (complete and partial response) and the duration of
      response to cabazitaxel as a single agent in participants with recurrent or refractory high
      grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG).

      Secondary Objectives:

      Phase 1 Part:

      To characterize the safety and tolerability of cabazitaxel in participants with recurrent or
      refractory solid tumors including tumors of the central nervous system.

      To characterize the pharmacokinetic (PK) profile of cabazitaxel in participants with
      recurrent or refractory solid tumors including tumors of the central nervous system.

      To evaluate preliminary anti-tumor activity that may be associated with cabazitaxel in
      participants with recurrent or refractory solid tumors including tumors of the central
      nervous system.

      Phase 2 Part:

      To characterize the safety and tolerability of cabazitaxel in participants with recurrent or
      refractory HGG or DIPG.

      To estimate progression free survival in participants with recurrent or refractory HGG or
      DIPG.

      To estimate overall survival in participants with recurrent or refractory HGG or DIPG.

      To characterize the plasma PK profile of cabazitaxel in participants with recurrent or
      refractory HGG or DIPG.
    

Detailed description: 
      The study duration will include a period for inclusion of up to 3 weeks and a 3-week
      treatment cycle(s). The participants may continue treatment until disease progression,
      unacceptable toxicity or willingness to stop followed by a minimum of 30-day follow-up.
    

Intervention name(s): Cabazitaxel (XRP6258)
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form: Injection Route of administration: Intravenous
Other intervention name(s): Jevtana
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Encouraging Healthy Food Shopping and Eating Behaviors by Price Reduction: A Community Supermarket Study
Condition: Obesity
Study type: Interventional

Summary: 
      The investigators plan to test the effect of price reduction of fruits and vegetables and
      non-caloric beverages on food purchasing, food intake, body weight, and body composition of
      primarily single adult shoppers. One hundred subjects will be randomized to an experimental
      or control group for a 4 month period. In the experimental group, there will be an automated
      50% reduction in fruits vegetables and non-caloric beverages during the middle 2-month
      period. The investigators expect to observe significant changes in food shopping and eating
      behavior during this period, which should lead to body weight and fat loss. Some of these new
      shopping patterns should persist in the last month of the study even though prices revert.
    


Intervention name(s): Discount intervention
Intervention type(s): Behavioral
Intervention description(s): 50% discount on selected fruits and vegetables at participating supermarket
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Ciclesonide and Fluticasone Propionate in Adult Patients With Moderate and Severe Persistent Asthma (18 to 75 y) (BY9010/IT-101)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to compare the safety and efficacy of ciclesonide versus fluticasone
      propionate on the lung function, symptoms, use of rescue medication, and occurrence of side
      effects (such as candidiasis, hoarseness) in adults with persistent asthma. Ciclesonide will
      be inhaled twice daily at one dose level; fluticasone propionate will be inhaled twice daily
      at one dose level. The study duration consists of a baseline period (2 weeks) and a treatment
      period (24 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; Fluticasone propionate
Factors Influencing Readmission Rates of Acute Traumatic Subdural Hematoma in the Elderly
Condition: Traumatic Subdural Hematoma
MeSH terms: Hematoma, Subdural; Hematoma, Subdural, Intracranial; Hematoma
Study type: Observational

Summary: 
      Acute traumatic subdural hematomas (TSDH) readmission rate is high (27.8%) with an increase
      in morbidity and cost for the elderly. This study identifies risk factors affecting
      readmission rates for these patients and presents strategies to reduce it.
    

Detailed description: 
      A retrospective analysis was conducted on patients with traumatic brain injuries (ICD-9-CM
      codes 800.20 - 801.86, 852.00 - 853.05) admitted between 2014 and 2016 at Genesys Regional
      Medical Center through the trauma service. From this group, the investigators selected
      patients admitted with traumatic SDH, and those patients were followed over the following 6
      months as regards to readmission status. Patients who were readmitted versus patients who
      were not readmitted were compared. The risk of readmission within 6 months of discharge for
      SDH was analyzed adjusting for age, prior anticoagulation use, Injury Severity Score (ISS),
      Glasgow Coma Scale (GCS), gender, time to readmission and co-morbid conditions which included
      diabetes mellitus, cardiovascular disease, renal disease, chronic obstructive pulmonary
      disease, and osteoporotic/orthopedic fractures using Cox Proportional Hazards Regression
      analysis.
    

Intervention name(s): Follow-up Care
Intervention type(s): Other
Intervention description(s): Follow up care provided upon readmission to patients who were diagnosed with a TSDH upon initial visit.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients admitted to a Community General Hospital who were diagnosed with a Traumatic
        Subdural Hematoma.
      
Keywords: subdural hematoma; readmission; risk factors
Long-Term Impact of COVID-19 Restrictions on Physical Activity and Social Interactions in Young Adults
Condition: COVID-19; Social Interaction; Physical Inactivity
MeSH terms: COVID-19
Study type: Observational

Summary: 
      There are studies on the impact of quarantine measures taken during the COVID-19 pandemic on
      individuals' social interactions and physical activities. We think that the adaptation of
      individuals who have had COVID-19 infection to return to social and physical activities after
      restrictions may affect participation in these activities. The aim of this study is to
      investigate the long-term impact of COVID-19 restrictions on physical activity and social
      interaction in young adults, depending on whether they have had a COVID-19 infection.
    

Detailed description: 
      Corona Virus Disease-19 was declared as a pandemic on 11 March 2020 by the World Health
      Organization. The fact that the measures taken to prevent the spread of the pandemic bring
      about a global quarantine process affects people's social interactions and physical activity
      levels with each other. The aim of this study is to investigate the long-term impact of
      COVID-19 restrictions on physical activity and social interaction in young adults, depending
      on whether they have had a COVID-19 infection. Physical activity levels were assessed with
      the short form of the International Physical Activity Questionnaire-Short Form. Social
      interactions and social phobias are Social Interaction Anxiety Scale and Social Phobia Scale
      were evaluated.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Young adults aged 18-25
      
Keywords: COVID-19 restrictions; Physical activity; Social interactions; Young adults
Antioxidant Supplementation in Pregnant Women With Low Antioxidant Status
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate antioxidants supplementation in pregnant women
      with low antioxidant status at 10-12 weeks gestation age in relation to adverse pregnancy
      outcome in randomized prospective study.
    

Detailed description: 
      Preeclampsia still remains a leading cause of feto-maternal mortality and morbidity in
      developed and developing world. Despite of intensive research, the underlying pathologic
      mechanisms of this disease remain elusive. It has been agreed that incomplete or absent
      transformation of spiral arteries by replacing endothelial cells and mural vascular smooth
      muscle cells has been observed in the placental bed of preeclamptic patients and severe cases
      of intrauterine growth restriction. Oxidative stress has been proposed as a link between
      these mechanisms. However, it has been demonstrated by two large studies that antioxidant
      supplementation does not reduce the risk of preeclampsia. Our initial study has been shown
      that antioxidant supplementation may be reduce the risk of preeclampsia in pregnant women
      with low antioxidant status.

      Comparison(s): adverse pregnancy outcome between vitamin C and E given and placebo given to
      pregnant women with low antioxidant status at 10-12 weeks gestation age
    

Intervention name(s): Vitamin C 1000mg and E 400IU
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: antioxidant supplementation; preeclampsia; prevention
Prevention of CF Exacerbation in Childhood: PREVEC Study
Condition: Cystic Fibrosis; Children; Exhaled Breath Condensate; Non-invasive Inflammatory Markers; Volatile Organic Compounds; Home Monitoring; Quality of Life
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      Pulmonary exacerbations of CF are an important cause for the experienced disability of
      patients, respiratory symptoms, and decreases in lungfunction, which require antibiotic
      therapy at home or in the hospital. Therefore, prevention of exacerbations in CF is
      important. The aim of this study was to assess the predictive properties of inflammatory
      markers in exhaled breath for pulmonary exacerbations in children with CF. In addition the
      reliability of home monitor assessments of symptoms and lungfunction was investigated.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children with Cystic Fibrosis
      
Keywords: Cystic Fibrosis; Children; Exhaled Breath Condensate; Non-invasive Inflammatory Markers; Volatile Organic Compounds; Home monitoring; Quality of life
A Study to Learn How the Study Medicine (Ponsegromab) is Changed and Eliminated From Healthy Chinese Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical trial is to learn about the safety of the study medicine
      (ponsegromab) and how it undergoes change and elimination in healthy Chinese adults. This
      study is seeking male and female Chinese participants who are very healthy as confirmed after
      some medical tests.

      All participants in this study will receive Ponsegromab only once:

        -  for half of the participants, ponsegromab will be given as a shot in the front of the
           thigh, abdomen, or outer area of the upper arm at the study clinic.

        -  for another half of the participants, ponsegromab will be given as four shots in the
           front of the thigh, abdomen, or outer area of the upper arm at the study clinic.

      We will measure the amount of the study medicine in the blood of the participants after
      giving the shots. Later we will examine experiences of people receiving the study medicine.
      This will help us understand how the medicine is changed and eliminated from your body and to
      decide if the study medicine is safe. Participants will take part in this study for 22 weeks.
      During this time, they will stay at the study clinic for the first 8 days and will visit the
      study clinic about 8 times.
    


Intervention name(s): Ponsegromab; Ponsegromab
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive one subcutaneous injection; Participants will receive four subcutaneous injections
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Ponsegromab; Healthy Volunteers
A Study in Healthy Male Subjects to Investigate Whether Administration of ACT-132577 Can Affect Rosuvastatin's Fate in the Body (Amount and Time of Presence in the Blood)
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to investigate the effect of Aprocitentan (ACT-132577)
      at steady state on the pharmacokinetics of single-dose rosuvastatin in healthy male subjects
    


Intervention name(s): Aprocitentan; Rosuvastatin
Intervention type(s): Drug; Drug
Intervention description(s): Capsule for oral administration; Tablet for oral administration
Other intervention name(s): ACT-132577
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Diroximel Fumarate (DRF) in Chinese and Caucasian Adult Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to evaluate the primary pharmacokinetic (PK) parameters of DRF
      active metabolite monomethyl fumarate (MMF) following multiple doses of DRF in Chinese and
      Caucasian adult healthy participants. The secondary objectives are to evaluate the secondary
      PK parameters of DRF active metabolite MMF following multiple doses of DRF in Chinese and
      Caucasian adult healthy participants, to evaluate the PK of DRF inactive major metabolite
      2-hydroxyethyl succinimide (HES) following multiple doses of DRF in Chinese and Caucasian
      adult healthy participants and to evaluate the safety and tolerability of multiple oral doses
      of DRF in Chinese and Caucasian adult healthy participants.
    


Intervention name(s): Diroximel fumarate
Intervention type(s): Drug
Intervention description(s): Administered as specified in the treatment arm
Other intervention name(s): Vumerity; BIIB098
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Adjunctive Treatment to Antidepressant Therapy for Adults With Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose is to study the efficacy, safety, and tolerability of LY2216684 as an
      adjunctive treatment for participants with major depressive disorder (MDD), who were
      identified as partial responders to an adequate course of treatment with a selective
      serotonin reuptake inhibitor (SSRI) (as defined by history).
    

Detailed description: 
      This is a 12 week multi-center, double-blind, placebo-controlled study on the efficacy of
      LY2216684 augmentation of selective serotonin reuptake inhibitors (SSRIs) in participants
      with MDD who have a partial response to treatment with an SSRI. While remaining on a steady
      dose of their SSRI treatment at entry into the study, participants will be randomly assigned
      to adjunctive treatment with LY2216684 or placebo in a 1:1 ratio for 10 weeks of acute
      treatment.
    

Intervention name(s): LY2216684; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Starting dose is 6 milligrams (mg), then titrate up to 9 mg, 12 mg, or 18 mg (3 tablets) administered orally (PO), once daily (QD) for up to 10 weeks followed by a 2 week taper.; 3 tablets PO QD for up to 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bioavailability of SC Formulation and Japanese Ethnobridging Study for PRA023
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized double-blind, placebo-controlled, single-dose study to evaluate the
      safety, tolerability, and pharmacokinetics of PRA023 in healthy Caucasian and Japanese adult
      volunteers
    


Intervention name(s): PRA023 IV Low Dose; PRA023 SC; Placebo IV; Placebo SC; PRA023 IV High Dose
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Drug; Drug; Placebo; Placebo; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Relative Bioavailability Study of Candesartan Cilexetil Under Fasting Conditions
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the relative bioavailability of two candidate tablet formulations
      of 16 milligram (mg) Candesartan cilexetil (GW615775) compared with the reference product
      ATACAND™ containing 16 mg Candesartan cilexetil in healthy human subjects. This is an
      open-label, randomized, single dose, three-way crossover, six sequence study enrolling 18
      healthy human subjects to ensure at least 14 subjects complete the study as planned. Each
      subject enrolled will participate in all three treatment periods and will be assigned to one
      of the six treatment sequences, in accordance with the randomization schedule. The treatment
      periods will be separated by a washout period of at least 7 days and no more than 14 days
      between dosing occasions. A follow up visit will be conducted 14-21 days post last dosing.
      ATACAND is a registered trademark of the AstraZeneca group of companies.
    


Intervention name(s): Candesartan Cilexetil in formulation 1; Candesartan Cilexetil in formulation 2; ATACAND
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Round, biconvex white tablets containing Candesartan cilexetil 16 mg for oral administration; Round, biconvex white tablets containing Candesartan cilexetil 16 mg for oral administration; Round, biconvex pink tablets containing Candesartan cilexetil 16 mg for oral administration
Intervention MeSH terms: Candesartan; Candesartan cilexetil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: relative bio-availability; fasting; GW615775; Candesartan cilexetil; ATACAND
The Effect of Serotonergic Modulation on Intestinal Permeability and Visceral Hypersensitivity in Healthy Individuals and Irritable Bowel Syndrome (IBS) Patients
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Hypersensitivity; Syndrome
Study type: Interventional

Summary: 
      Serotonin, 5-hydroxytryptamin (5-HT), plays an important role in regulating the
      gastrointestinal functions. In this study we will modulate the serotonin system with acute
      tryptophan depletion (ATD) and administration of 5-hydroxytryptophan (5-HTP). ATD is based on
      ingestion of an amino acid drink devoid of the precursor of serotonin and hence caused a
      decreased serotonin level. 5-hydroxy-tryptophan is the direct precursor of serotonin and its
      administration, an increased serotonin level is expected. During these interventions, gut
      permeability and visceral sensitivity will be measured in healthy individuals and patients
      with irritable bowel syndrome, which is characterized by altered permeability and visceral
      hypersensitivity.
    


Intervention name(s): Oxitriptan; Acute tryptophan depletion; Amino acid drink with tryptophan; Placebo capsule
Intervention type(s): Drug; Other; Other; Drug
Intervention description(s): 100 mg 5-Hydroxytryptophan will be administered orally.; Acute tryptophan depletion employs the oral ingestion of an amino acid mixture devoid of tryptophan, the precursor of serotonin, which results in lowered serotonin levels.; Amino acid drink with tryptophan, placebo for the ATD procedure; Placebo for 5-HTP
Intervention MeSH terms: Tryptophan; 5-Hydroxytryptophan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: serotonin; gut permeability; visceral sensitivity; irritable bowel syndrome
MagicTouch Sirolimus Drug Coated Balloon Catheter for the Treatment of Coronary Lesions
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the efficacy of MagicTouch DCB in reducing late
      lumen loss / suppressing neointimal tissue formation as assessed by Quantitative Coronary
      Angiography / Intravascular Ultrasound examination for the treatment of coronary artery
      lesions ranging from 3.0 mm to 3.5 mm of diameter and lesion length ≤ 15 mm.
    

Detailed description: 
      Prospective, multicenter, randomized study designed to enroll 60 subjects with In-stent
      Restenosis, To demonstrate the efficacy of MagicTouch Drug-Coated Balloon in reducing late
      lumen loss / suppressing neointimal tissue formation as assessed by Quantitative Coronary
      Angiography / Intravascular Ultrasound examination for the treatment of coronary artery
      lesions ranging from 3.0 mm to 3.5 mm of diameter and lesion length ≤ 15 mm.
    

Intervention name(s): MAGIC-TOUCH Drug-eluting Balloon
Intervention type(s): Device
Intervention description(s): in-stent restenosis treated with drug eluting balloon
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: drug-eluting balloon; in-stent restenosis