bioihbjkbjnl/mcl2 huggingface dataset:
A Study in Healthy Male Subjects to Understand How Savolitinib Behaves Inside the Body (Pharmacokinetics) When Administered Alone and in Combination With Famotidine
Condition: Solid Tumours
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be an open-label, randomised, 2 part (Part A and Part B), 2 treatment (savolitinib
      alone or in combination with famotidine), crossover study in healthy, non Japanese, male
      subjects, performed at a single study centre.
    

Detailed description: 
      Parts A and B will each have 2 Periods (Period 1 and Period 2) with a crossover design. Part
      B will be conducted only if results of Part A suggest a clinically meaningful effect of
      famotidine on savolitinib pharmacokinetics (PK) parameters. In both parts subjects will be
      randomly assigned 1:1 to receive one of the 2 treatment sequences: savolitinib alone first
      followed by crossover to the combination treatment of savolitinib+famotidine, or the reverse
      sequence. Subjects will be admitted for 4 days from one day before the first dose of the
      study drug and discharged 2 days after. There will be a washout period (no study treatment)
      of 14 days between the 2 Periods. The essential difference between the 2 parts is that in the
      combination treatment, famotidine will be administered 2 hours before savolitinib in Part A
      and 6 hours before savolitinib in Part B. A given subject will receive a total of 1 dose of
      famotidine and 2 doses of savolitinib during the study.

      In this 2 part study, 16 subjects will be randomised in each part to ensure at least 14
      evaluable subjects at the end of the last study period. If Part B is conducted, a total of 32
      subjects overall are planned to be enrolled in the study. Additional subjects may be enrolled
      to ensure 14 evaluable subjects in each part if more than 2 subjects are deemed non
      evaluable.
    

Intervention name(s): Savolitinib; Famotidine
Intervention type(s): Drug; Drug
Intervention description(s): Subject will receive savolitinib tablet 600mg orally after a high-fat, high-calorie meal.; Subjects will receive famotidine tablet 40mg orally after an overnight (minimum 8hours) of fasting.
Intervention MeSH terms: Famotidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Famotidine; Drug-drug interaction study; Small molecule kinase inhibitor
Abdominal Binder to Treat Orthostatic Hypotension (OH) in Parkinson's Disease (PD)
Condition: Parkinson's Disease; Neurogenic Orthostatic Hypotension in Parkinson's Disease
MeSH terms: Parkinson Disease; Hypotension, Orthostatic; Hypotension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the present study is to determine whether the use of an abdominal binder is
      effective in the non-pharmacological management of orthostatic hypotension in patients
      suffering from Parkinson's disease
    

Detailed description: 
      In the present single blinded cross-over trial we investigated the effects of an elastic
      abdominal binder on blood pressure changes (systolic, diastolic and mean blood pressure)
      after 3 minutes of head-up tilt test in patients with Parkinson's disease and orthostatic
      hypotension.

      Secondarily, we investigated the effects of an elastic abdominal binder on symptoms of
      orthostatic hypotension in daily living in a 4-weeks open-label follow-up.
    

Intervention name(s): Elastic abdominal binder; Placebo binder
Intervention type(s): Device; Device
Other intervention name(s): "Abdosyncro" Abdominalbandage, Syncro Med GmbH; "Clima Care" Body warmer, Bort Medical
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: N/A (the Intervention type in the present study was an elastic abdominal binder, which is a medical device)
Masking: Single (Participant)
Primary purpose: Treatment
Bioequivalence of Duvelisib and Food Effect on Pharmacokinetics of IPI-145
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To Evaluate the Bioequivalence of the two formulations of IPI-145 and the Effect of Food on
      the Pharmacokinetics of IPI-145
    

Detailed description: 
      This Phase 1, randomized, open-label study of IPI-145 will be conducted in 2 parts.

      Part 1 will be conducted in 2 cohorts. Cohort 1 will consist of 32 healthy subjects, and
      Cohort 2 will consist of 52 healthy subjects. Subjects in each cohort will receive 2 doses of
      IPI under fasted conditions in a 2-period, 2-sequence crossover design. Dosing in Period 1
      and Period 2 will be separated by at least 7 days.

      Part 2 is a 2-period, 2-sequence crossover design to assess the effect of a high-fat meal on
      the PK of the IPI-145 in 20 subjects. Subjects will receive single oral doses under fed
      (high-fat meal) and fasted conditions, separated by at least 7 days.
    

Intervention name(s): IPI-145 (duvelisib); IPI-145; IPI-145
Intervention type(s): Drug; Drug; Drug
Intervention description(s): High single oral dose capsule IPI-145 test formulation and IPI-145 reference formulation (capsule) high single oral dose; Low single oral dose capsule IPI-145 test formulation and IPI-145 reference formulation (capsule) low single oral dose; High single oral dose IPI-145 test formulation (capsule) with a high-fat meal and without food
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; Bioequivalence; Pharmacokinetics; Food; Healthy Adult
Effects of Montelukast in Asthmatic Children With and Without Food Allergy
Condition: Bronchial Asthma; Food Allergy; Children
MeSH terms: Asthma; Hypersensitivity; Food Hypersensitivity
Study type: Interventional
Phase: Phase 4

Summary: 
      -  To search the effects of montelukast on the airway inflammation including FEV1%,
           FEV1%/FVC, the provocholine® (methacoline chloride powder for inhalation) challenge
           tests, the leukotriene levels in the exhaled breath condensate in asthmatic children
           with and without food allergy aged 6-18 years old.

        -  To define the patient groups with good response to montelukast and to define the
           parameters which predict the good response.
    

Detailed description: 
      The aim of this analysis is to determine whether the children with food allergy may have more
      eosinophilic inflammation in the airways (as measured by FENO) or they may have Cysteinyl
      leukotrienes based inflammation in the airways that will be shown by high levels of Cys LT
      and low levels of lipoxin in the exhaled breath condensate. Our suggestion is that a special
      pattern of inflammation may be seen in asthmatics with food allergy because of their strong
      atopic march history and then we aimed to test if montelukast is more effective in children
      when the ratio of Cysteinyl LT inflammation is high relative to FENO (eosinophilic
      inflammation). This study will be the first to evaluate the effect of montelukast regarding
      the synthesis of Cys leukotrienes, lipoxin and FENO that will be measured from exhaled breath
      condensate, which is the mirror of the local inflammation in the airways in asthmatic
      children with atopy (food allergy). As we mentioned above another factor that we are planning
      to analyze is the ratio of Cys leukotriene to lipoxin, which is the natural antagonist of LT.
      This study will determine the ratio of Cyst LT to lipoxin and Cyst LT to FENO in the exhaled
      breath condensate and then there will be an analysis to see the correlation of these
      inflammatory markers with montelukast related changes on FEV1%, FEV1%/FVC.
    

Intervention name(s): Montelukast
Intervention type(s): Drug
Intervention description(s): Placebo and montelukast (5 mg for 6-14 years of age and 10 mg for 14-18 years of age once a day) will be given following one another in 4 weeks periods including a 2 weeks wash-out period in between in a cross over design.
Other intervention name(s): Singulair 5 mg tablets; Singulair 10 mg tablets; Placebo 5 mg tablets; Placebo 10 mg tablets
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Food allergy; Asthma; Children; Montelukast; Inflammation
Malaria Incidence in Infants in Bancoumana, Mali
Condition: Malaria Infection; Malaria Incidence; Anemia
MeSH terms: Malaria
Study type: Observational

Summary: 
      This study, conducted by the Malaria Research and Training Center at the Faculty of Medicine
      in Bamako and the NIAID will measure the frequency of occurrence of malaria in infants in
      Bancoumana, Mali. Information from the study will help in planning trials of malaria
      vaccines.

      Healthy children from 6 weeks to 6 months of age who live in the Bancoumana health area may
      be eligible for this study. Candidates are screened with a physical examination and blood
      tests.

      Participating children are visited at home for a total of about 17 visits to see if they are
      well. They come to the clinic every month during the 7-month study for a clinical evaluation,
      including a blood sample obtained by finger prick to test for malaria. Some of the blood
      collected may be stored and used for research. Children who become sick with malaria are
      treated for the disease.
    

Detailed description: 
      This is an observational study to determine the burden of malaria in rural Malian infants.
      Infants will be identified during a village-wide census and at Expanded Program for
      Immunization (EPI) visits. After obtaining community consent, eligible infants' parents will
      be invited to bring infants to the clinic for screening. Enrolled infants will receive a
      baseline evaluation and monthly visits during the rainy season at which times they will
      receive interim evaluations and heel, toe, or finger pricks for determinations of hemoglobin,
      thick and thin blood films, malaria antibody titers (at first and last visit for each
      transmission season), and hemoglobin typing at one visit. Study subjects will also receive a
      weekly home visit to determine if they are well or ill. If ill or febrile at any visit, or if
      they present to the clinic for an unscheduled visit, subjects will receive a history and
      physical examination, heel, toe, or finger pricks for determinations of hemoglobin, thick and
      thin blood films, filter paper blood collection and an RDT for malaria. Diagnosis and
      treatment of malaria will be performed according to Mali National Malaria Control Program
      (NMCP) guidelines. Diagnosis and treatment of other conditions will be performed as
      determined by the treating clinician.
    

Time perspective: Prospective
Keywords: Malaria Incidence; Anemia; Clinical Malaria
A Study to Evaluate the Safety and Efficacy of SM03 in Patients With Rheumatoid Arthritis Receiving Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluated the safety and efficacy of SM03 compared to placebo in patients with
      active rheumatoid arthritis(RA) receiving methotrexate
    


Intervention name(s): SM03; Placebo; Methotrexate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SM03: 600 mg intravenous (IV); Placebo: 600 mg intravenous (IV); methotrexate: 7.5-20 mg/week oral
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Stepped Care for Young Children After Trauma
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this R34 study is to develop and test the feasibility of a Stepped Care
      intervention for young children with Posttraumatic Stress Disorder (PTSD). Phase I will focus
      on developing and testing the feasibility of Stepped Care Trauma-Focused Cognitive Behavioral
      Therapy (SC-TF-CBT) in a small open trial (N=10). Phase II will consist of a randomized
      controlled trial (N=54) examining the efficacy of SC-TF-CBT relative to standard
      Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)on a number of outcome measures,
      treatment acceptability and satisfaction, and costs of treatment delivery. Findings from this
      pilot study will establish the feasibility and preliminary efficacy (see Kraemer et al.,
      2006) of SC-TF-CBT before progressing to a larger, randomized R01 to examine the
      effectiveness of SC-TF-CBT for early childhood PTSD.
    

Detailed description: 
      Young children who are exposed to traumatic events such as abuse, disasters, accidents,
      illnesses, injury and the death of a person close to them are at risk for developing PTSD.
      While effective treatments for childhood PTSD exist, novel interventions that are more
      accessible, efficient, and cost-effective are needed to improve access to evidence-based
      treatment. The purpose of this study is to develop and test the feasibility of an
      intervention called Stepped Care Trauma-Focused Cognitive Behavioral Therapy which has the
      potential to greatly improve service delivery approaches to make treatment more accessible
      and less costly, thereby reducing childhood PTSD and related societal impacts and costs.
    

Intervention name(s): Stepped Care TF-CBT; Standard TF-CBT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Stepped Care TF-CBT patients will receive step one: 3 (1 hr.) in-office therapist-led sessions over 6 weeks, the parent-child workbook (Stepping Together), scheduled weekly phone meetings (15 minutes), and information from the National Child Traumatic Stress Network website (via web or paper for those without access). Children who do not meet responder status will receive step two: 9 (1 to 1.5 hr.) in-office therapist-directed sessions of TF-CBT over 6 to 8 weeks.; Standard TF-CBT patients will receive 12 (1 to 1.5 hr.) standard weekly in-office therapist-directed sessions over 12 to 14 weeks (Phase II only). The 2 additional weeks allow for scheduling difficulty. Standard TF-CBT includes child, parent and conjoint parent-child sessions addressing the core trauma treatment components discussed in section a.3 (e.g. stress management, skill building, gradual exposure, & trauma narrative etc.).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stepped Care; Trauma-Focused Cognitive Behavioral Therapy; Preschool children
Pharmacokinetic Evaluation of Nalmefene Administered Intranasally to Healthy Volunteers
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be to compare the pharmacokinetics of nalmefene administration intranasal
      with and without an absorption enhancer compared to an intramuscular injection.
    

Detailed description: 
      This study will be an inpatient, double-blind, randomized, crossover study involving 14
      healthy volunteers. Each subject will receive 4 treatments during the 4 dosing
      periods.Subjects will stay in the inpatient facility for 17 days to complete the entire study
      and be discharged following completion of discharge procedures at the end of the last period.
      Subjects will be called 3 to 5 days after discharge to inquire concerning adverse events and
      concomitant medications since discharge. After obtaining informed consent, subject will be
      screened for eligibility. ON the day after clinic admission, subjects will be administered
      the intranasal-formulated drug in randomized order with 4 days between doses; the
      intramuscular dose will be administered during the fourth (last) treatment period.
    

Intervention name(s): Nalmefene
Intervention type(s): Drug
Intervention description(s): Comparing pharmacokinetics of intranasal nalmefene to intramuscular nalmefene
Other intervention name(s): Selincro
Intervention MeSH terms: Nalmefene
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Phase III Study to Assess the Long Term Efficacy, Carry-over Effect and Safety of 300 IR Sublingual Immunotherapy Tablets
Condition: Allergy
Study type: Interventional
Phase: Phase 3

Summary: 
      A phase III study to evaluate Long term efficacy , carry-over effect and safety of 300 IR
      sublingual Immunotherapy (SLIT) tablets in adults patients suffering from grass pollen
      rhinoconjunctivitis
    


Intervention name(s): 300 IR (4M); 300 IR (2M); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 300 IR grass pollen allergen extract tablet starting 4 months before the pollen season; 300 IR grass pollen allergen extract tablet starting 2 months before the pollen season; Placebo tablet
Other intervention name(s): Sublingual immunotherapy tablet; Sublingual immunotherapy tablet; Sublingual placebo tablet
Intervention MeSH terms: Immunomodulating Agents; Immunologic Factors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Sublingual immunotherapy; Grass pollen tablet; Allergic rhinoconjunctivitis
Substudy 'B' of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)
Condition: Device Latency
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the accuracy of IEM detection by the MIND1 System
      by completing a series of Patch applications and IEM ingestions in the clinic.
    

Detailed description: 
      The OSMITTER study protocol is designed as a master protocol governing multiple substudies
      for the rapid assessment of candidate subcomponents for the MIND1 System. This substudy is
      being conducted to determine the accuracy of IEM detection by the MIND1 System by completing
      a series of Patch applications and IEM ingestions in the clinic. Following placement of the
      Patch by clinic staff, subjects will ingest one placebo-embedded IEM tablet approximately
      every other hour, for a total of 4 ingestions.

      Placebo-embedded IEM tablets are being tested to measure the accuracy of IEM detection by the
      MIND1 system. Approximately 30 healthy volunteer subjects will be enrolled in the substudy.
      The duration of this substudy from Visit 1 (Day 1) to safety follow-up will be approximately
      1 week, of which approximately 1 day will be allotted for active subject participation, plus
      a 1-week safety follow-up period.
    

Intervention name(s): MIND1 System
Intervention type(s): Device
Intervention description(s): Following placement of the Patch by clinic staff, subjects will ingest one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions. Subjects may eat as they wish over the course of the day. Placebo-embedded IEM tablets are being tested to measure the accuracy of IEM detection by the MIND1 system. Clinic staff will record the time of each ingestion of an IEM. Clinic staff will check the compatible computing device (eg, smartphone) at 30-minute intervals for the presence of a timeline ingestion tile and will record the time it is detected by the MIND1 System compatible computing device (eg, smartphone).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: OPC-14597 Digital; Aripiprazole; Medical Information Device #1 System (MIND1); Ingestible Event Marker
The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)
Condition: Secondary Hypogonadism
MeSH terms: Neoplasm Metastasis; Hypogonadism
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will determine the effects of three doses of Androxal(enclomiphene citrate)on
      morning testosterone versus AndroGel(approved topical treatment)in men with low testosterone
      (<350 ng/dL)after 6 weeks of continuous dosing.
    

Detailed description: 
      Study will require 7 visits, which includes 2 overnight stays in a clinic. One visit is an
      eye exam. Blood samples are required at all visits including sampling every hour for a 24
      hour time period during the 2 overnight stays. A six month extension study will be available
      for all subjects completing the 6-week study.
    

Intervention name(s): Androxal (enclomiphene citrate); Testosterone
Intervention type(s): Drug; Drug
Intervention description(s): capsule oral
1X a day 6 weeks; topical gel
1X a day 6 weeks
Other intervention name(s): Androxal; low testosterone therapy; topical testosterone; testosterone gel; exogenous testosterone
Intervention MeSH terms: Methyltestosterone; Enclomiphene; Clomiphene; Zuclomiphene; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
AVODART® Alopecia Post-marketing Surveillance (PMS)
Condition: Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Observational

Summary: 
      Post-marketing surveillance(PMS) to monitor the safety and effectiveness of dutasteride in
      Korean androgenetic alopecia patients
    

Detailed description: 
      An open label, multi-centre, non-interventional post-marketing surveillance to monitor the
      safety and effectiveness of dutasteride administered in Korean androgenetic alopecia patients
      according to the prescribing information
    

Intervention name(s): Dutasteride
Intervention type(s): Drug
Intervention description(s): Basically there is no treatment allocation. Subjects who would be administered of dutasteride at their physicians' discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.
Intervention MeSH terms: Dutasteride
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients administrated dutasteride with male pattern hair loss (androgenetic alopecia)
      
Keywords: Dutasteride
Clinical Evaluation of Sectional Matrix Versus Circumferential Matrix for Reproduction of Proximal Contact
Condition: Proximal Contact
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effects of different matricing techniques either
      sectional matrix or circumferential matrix on reproduction of optimum proximal contacts and
      contours during restoration of class II cavities with resin composite by undergraduate
      students or postgraduate dentists.
    


Intervention name(s): MD ring and precontoured sectional matrix by TOR VM; Circumferential matrix and tofflemire retainer by Kerr
Intervention type(s): Device; Device
Intervention description(s): MD ring (separation ring) and precontoured sectional matrix (thickness 0.035mm hard) and a wedge was used to secure matrix in place; Circumferential matrix (thickness 0.038mm) applied by tofflemire retainer and secured in place with wedge
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment