bioihbjkbjnl/mcl2 huggingface dataset:
Bioavailability and Pharmacokinetics of Lefamulin When Administered to Fed and Fasted Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1 study to assess the bioavailability and pharmacokinetics of a 600 mg immediate
      release tablet formulation of lefamulin when administered to fed and fasted healthy subjects
      in comparison to an intravenous formulation and a capsule formulation.
    

Detailed description: 
      This is a single center, single cohort, open label, randomized, four- period cross-over study
      with healthy subjects receiving a single dose of lefamulin at four study sessions at least 4
      days apart. Lefamulin will be taken: 1) as 600 mg IR tablet orally in the fasted state; 2) as
      600 mg API in capsule (3 x 200 mg capsules) orally in the fasted state; 3) as 150 mg i.v.
      infusion in 250 mL citrate buffered saline over 1 h; 4) as 600 mg IR tablet orally one hour
      after breakfast.

      The order will be randomized. A total of 20 healthy subjects will be enrolled in the study.
      The same subjects will take part in all study sessions.

      After each study session, the Safety Monitoring Team will review the safety and tolerance
      data before the commencement of the subsequent session.
    

Intervention name(s): Lefamulin
Intervention type(s): Drug
Intervention description(s): Lefamulin administered iv or orally in the fasted state and orally in the fed state
Other intervention name(s): BC-3781
Intervention MeSH terms: Lefamulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Absolute bioavailability; Pharmacokinetics
Guided Self-Help Treatment for Binge Eating Disorder
Condition: Eating Disorders; Bulimia
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional

Summary: 
      This study will determine the effectiveness of guided self-help treatment in treating
      individuals with binge eating disorder (BED).
    

Detailed description: 
      Binge eating disorder (BED) is a serious condition characterized by compulsive overeating and
      feelings of powerlessness. The condition often has a negative impact on both physical and
      emotional health. This study will examine ways to help people determine whether they have BED
      and will test whether guided self-help (GSH) treatment is effective in treating BED.

      Participants will be randomly assigned to receive either GSH treatment or usual clinical care
      (which may include general support and talk therapy) for 3 months. The GSH treatment is a
      cognitive behavioral therapy-based program that will be administered over 8 sessions.
      Participants receiving GSH will be given a book that focuses on dealing with BED; they will
      also meet with a therapist regularly to have their progress monitored. The Eating Disorders
      Examination (EDE), self-reports, questionnaires, and surveys will be used to assess
      participants. Assessments will be conducted at study entry, at Weeks 2 and 4 of the
      treatment, at the end of the treatment, and at 6 and 12 months post-treatment.
    

Intervention name(s): Guided self-help cognitive behavioral therapy (CBT); Usual clinical care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants receive eight sessions of guided self-help CBT.; Control group participants receive treatment as usual.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Binge Eating; Overeating; Compulsive Eating; Hyperphagia
Study of the Pharmacokinetics of Intravenous Administered 14C-MNTX
Condition: Healthy Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, radiotracer study, to be conducted in healthy, normal, male
      volunteers. It will entail intravenous administration of a single dose of 14C-MNTX,
      collection of excretions, and periodic drawing of blood samples. Exhaled 14CO2 will also be
      sampled as a measure of the extent of possible metabolic MNTX demethylation.
    


Intervention name(s): IV methylnaltrexone (MNTX)
Intervention type(s): Drug
Intervention MeSH terms: Methylnaltrexone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Gait Modification Treatment for Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Knee osteoarthritis (OA) is a costly health condition affecting more than 10% of Canadian
      adults. Excessive and unbalanced loads passing through the knee joint have been implicated in
      the progression of OA. Typical conservative treatment of OA has focused on increasing daily
      activity, without consideration for the underlying joint loading. This study aims to compare
      a 4-month walking program that aims to increase the angle of the foot (toe-out angle) during
      walking - a measure shown to reduce joint loading and OA disease progression - while
      increasing walking time/distance, with a standard walking program that aims to increase
      walking time/distance. It is predicted that the walking program focusing on increasing
      toe-out will provide greater reductions in self-reported knee pain and a greater reduction in
      unfavorable knee joint loading.
    


Intervention name(s): Progressive walking program with toe-out gait modification; Progressive walking program
Intervention type(s): Other; Other
Intervention description(s): Participants in this study group will perform continuous treadmill walking for a minimum of 30 minutes at each session, but the emphasis will be to increase toe-out angle by 10 degrees over that exhibited at baseline. A mirror will be provided for biofeedback and participants will be instructed on its use for achieving the target toe-out angle. Increased walking time and distance will be encouraged the same as for the control group.; At each scheduled visit, participants will perform treadmill walking for a minimum of 30 minutes depending on the individual's baseline activity level and the stage of the intervention. Emphasis will be solely on increasing walking time and distance to achieve the target of a 40% increase in daily activity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: osteoarthritis; knee; walking; toeout; gait modification
Posterior CAD/CAM Cobalt-chromium Alloy Single Crowns: 4-year Prospective Clinical Study
Condition: Single Tooth Lost
MeSH terms: Tooth Loss
Study type: Interventional

Summary: 
      Objectives - To evaluate the 4-year clinical outcomes of ceramic veneered Computer Aided
      Design/Computer Aided Manufacturing (CAD/CAM) Co-Cr single crowns supported by natural teeth
      in posterior regions.

      Material and methods - Eighty-nine patients were provided with 120 ceramic veneered CAD/CAM
      Co-Cr single crowns replacing either premolars and molars. Specific inclusion criteria were
      needed and tooth preparations were standardized and performed by 2 expert prosthodontists.
      CAD/CAM Co-Cr frameworks were fabricated and veneered with ceramics. The restorations were
      cemented using a eugenol-free zinc oxide luting agent. The patients were recalled after 1, 6,
      12, 24, 36 and 48 months. The survival and success of the restorations were evaluated. The
      technical and esthetic outcomes were examined using the United States Public Health Service
      criteria. The biologic outcomes were analyzed at abutment and contralateral teeth and
      descriptive statistics were performed.
    


Intervention name(s): Co-Cr single crown; Periodontal parameters
Intervention type(s): Device; Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI0639 in Advanced Solid Tumors
Condition: Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-time-in-human, Phase 1, multicenter, open-label, single-arm, dose-escalation
      (3+3) study to evaluate the safety, tolerability, antitumor activity, PK and immunogenicity
      of MEDI0639.
    

Detailed description: 
      This is a first-time-in-human, Phase 1, multicenter, open-label, single-arm, dose-escalation
      (3+3) study to evaluate the safety, tolerability, antitumor activity, PK, and immunogenicity
      of MEDI0639 in adult subjects with advanced solid tumors refractory to standard therapy or
      for which no standard therapy exist. Up to 63 subjects will be enrolled at approximately 3 to
      5 study centers in North America.
    

Intervention name(s): MEDI0639
Intervention type(s): Biological
Intervention description(s): MEDI0639 is an immunoglobulin G1 lambda (IgG1λ) monoclonal antibody. MEDI0639 selectively binds to DLL4 and blocks its ability to bind to and activate signaling through the Notch receptors.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer
Efficacy and Safety of Olaparib in Pretreated Patients With Measurable Colorectal Cancer, Stratified by Microsatellite Instability (MSI) Status
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being carried out to see if the new drug, olaparib (AZD2281), can effectively
      and safely treat advanced large bowel cancer. The primary goal of this clinical trial is to
      determine whether olaparib will have a beneficial effect on the patient's cancer by causing a
      response and increasing the time it takes for the cancer to progress.
    


Intervention name(s): olaparib
Intervention type(s): Drug
Intervention description(s): 400 mg po bid continuously
Intervention MeSH terms: Olaparib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Colorectal cancer; Olaparib; MSI status; Stage IV; Measurable Colorectal Cancer; Stratified by MSI Status
A Phase 2 Clinical Study in Subjects With Primary Progressive Multiple Sclerosis to Assess the Efficacy, Safety and Tolerability of Two Oral Doses of Laquinimod Either of 0.6 mg/Day or 1.5mg/Day (Experimental Drug) as Compared to Placebo
Condition: Primary Progressive Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2 study is intended to serve as a proof of concept for potential treatment with
      laquinimod in patients with PPMS. The study is also aimed at evaluating 2 doses of laquinimod
      in this population.
    

Detailed description: 
      Due to serious cardiovascular adverse events, Data Monitoring Committee (DMC) made a
      recommendation to stop all laquinimod treatment arms above 0.6 mg in the multiple sclerosis
      (MS) trials; therefore the 1.5 mg treatment arm in the ARPEGGIO study was discontinued as of
      01 January 2016.

      The DMC did not identify any definite cardiovascular risk in the 0.6 mg treatment arm, but
      felt that long term monitoring for emergence of any potential signal was necessary.
      Therefore, the 0.6 mg treatment arm was continued while the sponsor closely monitored
      cardiovascular events in all laquinimod studies. Prior to 01 January 2016, eligible patients
      were randomized in a 1:1:1 ratio into 1 of the following treatment arms (a total of 286
      patients were randomized 1:1:1 prior to

      01 January 2016):

        -  Laquinimod 0.6 mg daily

        -  Laquinimod 1.5 mg daily

        -  Daily placebo

      As of 01 January 2016, following the decision to discontinue the laquinimod 1.5 mg dose arm,
      additional eligible patients (87 patients) who were enrolled were randomized in a 1:1 ratio
      into one of the following treatment arms:

        -  Laquinimod 0.6 mg daily

        -  Daily placebo
    

Intervention name(s): Placebo; Laquinimod; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo; Laquinimod capsules in 0.5 mg and 0.6 mg strengths; Placebo capsules
Other intervention name(s): TV-5600
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: multiple sclerosis; primary progressive multiple sclerosis; oral immunomodulator
Evaluating the Relationship Between Environmental Risk Factors in Housing Types and Chronic Respiratory Diseases in Ho Chi Minh City
Condition: Chronic Respiratory Diseases
MeSH terms: Respiratory Tract Diseases; Respiration Disorders
Study type: Interventional

Summary: 
      The research question is "Are the different types of house in Ho Chi Minh city equally
      contributing to chronic respiratory diseases?".

      According to this question, a cross-sectional and explorative study was set up to explore the
      differences in the environmental characteristics and prevalence of chronic respiratory
      diseases among common housing types in Ho Chi Minh city. Preliminary work was performed in
      100 houses (20 houses per type, included tube houses, rental houses, rural houses, slum and
      apartment) from November 2013 to June 2015. It included measures by environmental devices,
      questionnaires and indoor activities diaries.

      This study will aim to collect information about the prevalence of chronic respiratory
      diseases (CRDs) inside those house types to understand more about role of house types in
      developing CRDs.

      The objective is:

        1. to evaluate the relationships between the type of house and lung function of inhabitants
           in each housing type.

        2. to evaluate the effects of environmental risk factors in each house type on prevalence
           of CRDs
    


Intervention name(s): Questionnaire; Lung function test
Intervention type(s): Other; Device
Intervention description(s): Basic lung function test performed with a micro-spirometer, without broncho dilatator
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: chronic respiratory diseases; housing; lung function test
Effect of the Amount of Fluoride Toothpaste on Fluoride Availability in the Oral Fluids in Children
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to determine the fluoride availability in saliva and dental biofilm
      after the use of increasing amounts of fluoride toothpaste. Using a crossover and blind
      design, 15 children (18-42 months old) had their teeth brushed with increasing amounts of
      fluoride toothpaste. Fluoride concentration in saliva and dental biofilm was determined up to
      30 min after brushing.
    

Detailed description: 
      The aim of the study is to determine the fluoride availability in saliva and dental biofilm
      after the use of increasing amounts of fluoride toothpaste. Children from 18 to 42 months
      from a community daycare participated. The study had a crossover and blind design. The
      amounts of toothpastes tested were: 1. A pea-size amount (0.3 g) of a non-F toothpaste; 2.
      0.025 g of a F toothpaste (1,100 ppm F, as NaF); 3. 0.05 g of the same F toothpaste; 4. 0.1 g
      of the same F toothpaste; or 5. 0.3 g (pea-size) of the same F toothpaste. Children were to
      brush their teeth with the designated amount of toothpaste twice/day from Monday to Friday.
      In order to allow biofilm accumulation, caregivers were instructed to brush only the occlusal
      surfaces of primary molars. On Friday morning, at least one hour after breakfast, saliva and
      one biofilm sample from the right or left hemiarch were collected and analyzed for fluoride
      concentration. Then, brushing with the respective amount of toothpaste was performed, and
      saliva was collected 5, 15 and 30 min later. The biofilm from the other side of the mouth was
      collected after 30 min. Fluoride concentration in saliva and biofilm samples was determined
      with an ion-specific electrode.
    

Intervention name(s): Toothbrushing
Intervention type(s): Procedure
Intervention description(s): Toothbrushing with different amounts of fluoride toothpaste (or a non-fluoride toothpaste as a control)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: dental caries; fluoride; toothpaste; dentifrice
Anterior Referencing Versus Posterior Referencing in Minimally Invasive Total Knee Arthroplasty
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The purpose of this study is to look at two different referencing systems for total knee
      replacement surgery. In anterior referencing system, referencing cuts are made from the front
      surface of the femur. This allows for a more exact cut. The anterior referencing system is
      more difficult for the surgeon to use. This may increase surgery time. Posterior referencing,
      on the other hand, references cuts from the back of the femur. The posterior referencing
      system is quick and easy for the surgeon to use. Posterior referencing may lead to notching
      of the femur. The risk of notching is very low and may not affect your results. This is a
      study that has never been done before. Dr. Heekin uses both referencing systems in his
      practice. He would like to determine which knee referencing system allows for greater knee
      flexion after surgery. Knee flexion correlates with function and the ability to return to
      everyday activities. For example, getting up from a chair, going up and down stairs,
      stooping, and kneeling.
    


Intervention name(s): Total knee
Intervention type(s): Procedure
Intervention description(s): Primary Total knee
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: total knee arthroplasty
Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants
Condition: Bronchopulmonary Dysplasia
MeSH terms: Bronchopulmonary Dysplasia; Hyperplasia
Study type: Interventional
Phase: Phase 3

Summary: 
      This phase 3, multi-center, double blind, placebo-controlled, randomized clinical trial will
      attempt to demonstrate if preterm infants who require mechanical ventilation and/or positive
      pressure support at any point during days 5 to 14 after birth may benefit from treatment with
      iNO.
    

Detailed description: 
      Multi-center, double blind, placebo-controlled, randomized clinical trial. Infants who meet
      all enrollment criteria at any point during days 5 to 14 after birth will be randomized to
      inhaled NO starting at 20 ppm, or matching placebo, by means of a blinded INOvent® delivery
      device. All infants will receive 24 days of therapy, following a dose reduction schedule.
      Infants who are extubated before 24 days will continue therapy via nasal continuous positive
      airway pressure (CPAP) or nasal cannula to complete 24 days' of therapy. The primary outcome
      measure will be survival without BPD at 36 weeks gestational age using a physiologic
      assessment of BPD.
    

Intervention name(s): Inhaled Nitric Oxide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.; Nitrogen gas will be administered in the same manner as the experimental drug.
Other intervention name(s): INOmax; Nitrogen gas
Intervention MeSH terms: Nitric Oxide
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Bronchopulmonary Dysplasia, BPD
Effect of Exercise on Premature Ejaculation
Condition: Premature Ejaculation
MeSH terms: Premature Birth; Premature Ejaculation
Study type: Observational [Patient Registry]

Summary: 
      Premature ejaculation (PE) is one of the prevalent disorders in men; its leading sequel such
      as lack of self-confidence, anxiety, depression and unsatisfactory intercourse in men and
      their partners. The current study was aimed to evaluate the relationship between ejaculation
      and physical activity.
    

Detailed description: 
      Premature ejaculation (PE) is the most frequent sexual dysfunction in males, and its
      prevalence has been reported as 21-33%. Currently, there are no universal criteria for the
      diagnosis, or treatment strategies or approaches for PE. Lack of observational studies
      directed to PE makes comprehension of this sexual dysfunction difficult. The common point for
      definition of PE is a short duration between penetration and ejaculation, little or no
      control on voluntary control of ejaculation, and annoying character and negative effect of
      this condition on the individual. There are various treatment methods since ejaculation
      physiology and neuroanatomy is not yet clearly demonstrated. According to neurobiological
      hypothesis of Waldinger, a dysfunction in the serotonin pathway of the central system such as
      serotonin-2C hyposensitivity and/or serotonin-1A receptor hypersensitivity is a possible
      cause of lifelong PE. These experimental animal models showed that serotonergic activity at
      hypothalamic level inhibited ejaculation reflex. Based on this physiological effect,
      selective serotonin reuptake inhibitors (SSRI), and serotonin agonists increase intravaginal
      ejaculation latency time (IELT). A number of studies showed that exercise increased the
      functional effect of serotonin in the human brain.

      The effects of physical activity level on human health have attracted interest worldwide.
      Lack of physical activity forms the basis of various health problems, however regular
      physical act contributes prevention and treatment of a number of disorders.

      In current study, investigators will compare the ejaculation control, IELT, and prevalence of
      PE between sportsmen that have regular physical activity, and the individuals with a
      sedentary lifestyle.
    

Intervention name(s): physical exercise
Intervention type(s): Behavioral
Intervention description(s): regular exercise programs in the previous 6 months.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The participants are 18-45 year-old, and have regular sexual activity for at least 6
        months. A comparison was made by metabolic equivalents (MET), premature ejaculation
        diagnostic tool (PEDT) and intravaginal ejaculatory latency time (IELT).
      
Keywords: premature ejaculation; intravaginal ejaculatory latency time; premature ejaculation diagnostic tools