bioihbjkbjnl/mcl2 huggingface dataset:
Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the trial was to evaluate the efficacy and safety of two different doses of
      QVM149 (QVM149 150/50/80 μg and QVM149 150/50/160 μg via Concept1) over two respective QMF149
      doses (QMF149 150/160 μg and QMF149 150/320) μg via Concept1 in poorly controlled asthmatics
      as determined by pulmonary function testing and effects on asthma control.
    

Detailed description: 
      This study used a 52-week treatment, randomized, double-blind, double-dummy, parallel-group
      design. A total of 3092 asthma patients were randomized into the 5 treatment groups with a
      randomization ratio of 1:1:1:1:1 (approximately 617 patients per treatment group): QVM149
      150/50/80 μg once daily (o.d.), QVM149 150/50/160 μg o.d., QMF149 150/160 μg o.d. and QMF149
      150/320 μg o.d., all delivered via the Concept1 device, and salmeterol/fluticasone 50/500 μg
      twice daily (b.i.d.) delivered via Accuhaler. The 52 week treatment period was followed by a
      30-day Follow-up.

      The primary objective of this study was to demonstrate superiority of either QVM149 150/50/80
      μg o.d. to QMF149 150/160 μg o.d. or QVM149 150/50/160 μg o.d. to QMF149 150/320 μg o.d in
      terms of trough Forced Expiratory Volume in One Second (Trough FEV1) (FEV1) at Week 26, all
      delivered via Concept1.
    

Intervention name(s): QVM149 150/50/160; QVM149 150/50/80; QMF149 150/320; QMF149 150/160; salmeterol/fluticasone
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Fluticasone; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; QVM149; QMF149
Evaluating Parenting Styles and Child Temperament Associated With Child Anxiety Disorders
Condition: Anxiety Disorders; Obsessive Compulsive Disorder
MeSH terms: Anxiety Disorders; Obsessive-Compulsive Disorder
Study type: Observational

Summary: 
      This study will look at similarities and differences in family processes and child
      temperament among children with and without symptoms of anxiety disorders.
    

Detailed description: 
      Anxiety disorders are among the most common childhood disorders. Although anxiety is a normal
      part of life and growing up, for some children this anxiety becomes chronic, relentless, and
      progressively worse if left untreated. Physical symptoms typically accompany the intense
      anxiety caused by the disorder, and may include blushing, profuse sweating, trembling,
      nausea, and difficulty talking. Effective treatments for anxiety disorders are available, and
      research continues to yield new, improved therapies that can help most people with anxiety
      disorders to lead productive, fulfilling lives. This study will look at similarities and
      differences in family processes and child temperament among children with and without
      symptoms of anxiety disorders. Results from this study may improve future treatment of
      children with anxiety disorders.

      Families participating in this observational study will be mailed parent and child
      questionnaires that should be completed prior to the first study session. The child
      questionnaires will ask for information regarding the child's feelings and family
      interactions. Parent questionnaires will ask for information about their own personal
      feelings as well as the child's feelings, symptoms, and behaviors. Study participation will
      last 2 days. On the first day of the study, families will undergo a 3-hour diagnostic
      interview in which questions similar to those found on the questionnaires will be revisited.
      On the second day, mothers and their children will participate in three different observation
      tasks that explore how families interact and respond to certain situations. These tasks may
      include discussing certain anxiety-provoking situations, putting puzzles together, and
      creating an ending to a story. Before each task, the child will be placed alone in a separate
      room where the child will be asked to relax. Throughout the tasks, the child's heart rate and
      breathing will be recorded by a machine. The tasks will be videotaped but will be viewed only
      by research staff for data analysis purposes and to ensure that all safety procedures were
      followed. Upon study completion, if it appears that a child has an anxiety disorder, parents
      of the child will be notified and will receive treatment referrals as needed.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community Sample
      
Keywords: Children; Healthy Controls; Assessment
Naturally Banded Sleeve Gastrectomy
Condition: Obesity, Morbid
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      the idea is to use an omental flap or round ligament as a natural band in stead of
      synesthetic band in bariatric procedures, mainly gastric sleeve
    

Detailed description: 
      the idea is to use an omental flap or round ligament as a natural band in stead of
      synesthetic band in bariatric procedures, mainly gastric sleeve
    

Intervention name(s): LSG with omental band; LSG
Intervention type(s): Procedure; Procedure
Intervention description(s): LSG with omental band; just to do sleeve gastrectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study to Compare Two Forms of LY2608204 in Healthy People
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare 2 formulations of the study drug (LY2608204) in terms
      of how much gets into the blood stream and how long it takes the body to get rid of it.
      Information about any side effects that may occur will also be collected.
    


Intervention name(s): LY2608204 Reference; LY2608204 Test
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally.
Other intervention name(s): Glucokinase Activator; Glucokinase Activator
Intervention MeSH terms: Globalagliatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Diabetes Mellitus, Type 2
Mindfulness and Psychedelics
Condition: Healthy Participants
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The investigators are doing this project to investigate potential neurophysiological synergy
      effects between mindfulness meditation and psychedelics. Previous studies have found that
      both mindfulness and psychedelics like psilocybin modulate neural activity and connectivity
      of the same brain network. However, little is known about the potential interactions between
      mindfulness meditation and psychedelics. The indigenous plant preparation "Ayahuasca" is
      particularly interesting for the combination with mindfulness meditation. It contains two
      components, N,N-dimethyltryptamine (DMT) and harmine, which are very similar to the body's
      own messenger substance serotonin and increase its effect in the body. The investigators
      would now like to find out how these corresponding networks change in experienced meditators
      after DMT/Harmine-enhanced mindfulness meditation and how this affects their subjective
      experience. For this functional MRI imaging will be performed, as well as psychometric
      assessments and detailed experiential interviews before and after a three-day meditation
      retreat. Participants will be randomly assigned to one of two groups. One group receives DMT
      and harmine during the sitting meditation on the second day, the other group receives a
      corresponding placebo. Neither the participants nor the investigator know who will receive a
      placebo or the combination of DMT/harmine on the day of the experiment. The pre- and
      post-measurements of the MRI imaging and psychometric questionnaires of the DMT/Harmine group
      are compared with those of the placebo control group. By examining the synergistic effects of
      mindfulness meditation and DMT/harmine, the aim of this study is to contribute to a
      comprehensive understanding of the neurophenomenology of rare and inaccessible phenomena of
      consciousness.
    


Intervention name(s): DMT + harmine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The intervention used in this study is a combination of the two main ingredients of ayahuasca, DMT (N,N-dimethyltryptamine) and harmine in purified form.; The placebo consists of pharmaceutically inactive ingredients and additional flavors, and is organoleptically hardly distinguishable from the verum.
Intervention MeSH terms: Harmine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind, randomized, placebo-controlled, between-subjects study design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: DMT; harmine; pharmahuasca; ayahuasca; healthy participants; meditation; group retreat; mindfulness
Replication of the POET-COPD Trial in Healthcare Claims Data
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      Investigators are building an empirical evidence base for real world data through large-scale
      replication of randomized controlled trials. The investigators' goal is to understand for
      what types of clinical questions real world data analyses can be conducted with confidence
      and how to implement such studies.
    

Detailed description: 
      This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE
      initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical
      School. It is intended to replicate, as closely as is possible in healthcare insurance claims
      data, the trial listed below/above. Although many features of the trial cannot be directly
      replicated in healthcare claims, key design features, including outcomes, exposures, and
      inclusion/exclusion criteria, were selected to proxy those features from the trial.
      Randomization is also not replicable in healthcare claims data but was proxied through a
      statistical balancing of measured covariates according to standard practice. Investigators
      assume that the RCT provides the reference standard treatment effect estimate and that
      failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims
      data for replication for a range of possible reasons and does not provide information on the
      validity of the original RCT finding.
    

Intervention name(s): Salmeterol; Tiotropium
Intervention type(s): Drug; Drug
Intervention description(s): Salmeterol inhaler dispensing claim is used as the reference; Tiotropium dispensing claim is used as the reference
Intervention MeSH terms: Tiotropium Bromide; Salmeterol Xinafoate
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with chronic obstructive pulmonary disease (COPD)
Intravesical Epirubicin Plus BCG to Prevent the Recurrence of Transitional Cell Carcinoma of Bladder
Condition: Bladder Neoplasms
MeSH terms: Carcinoma; Carcinoma, Transitional Cell; Urinary Bladder Neoplasms; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      Biochemotherapy (combined immunotherapeutic drugs and chemotherapeutic drugs) has shown
      virtue than that use chemical or biological drugs alone in the treatment of some malignant
      tumor. Here we investigated the efficacy of sequential intravesical therapy with EPI and BCG
      to EPI or BCG alone in patients with transitional cell carcinoma of bladder cancer after
      surgical management.
    

Detailed description: 
      Methods From July 1996 to November 2003, a total of 138 cases of bladder cancer underwent
      TURBT or partial cystectomy were entered the trail. They were divided into 3 groups randomly:
      1, EPI plus BCG; 2, use BCG alone; and 3, use EPI alone. All the patients have been followed
      up for 28-40 months after surgery (average time was 36 months), and the frequency of
      bacterial, chemical cystitis and other local side effects were also observed.Results After a
      median follow up of 36 months, the number of recurrences in group 1 was significantly reduced
      than group 2 and 3 (p<0.05 vs group 2 and 3, x2-test). The frequency of bacterial, chemical
      cystitis and other local side effects was similar in group 1 and 2, whereas significant
      severe side effect was found in group 3 (p<0.05 vs group 2 and 1, x2-test). Allergic
      reactions, including skin rash, were more frequent in group 3, and other systemic effects
      were more frequent in group 1. Conclusion Biochemotherapy by single dose EPI plus sequential
      BCG intravesical is markedly effect in preventing the recurrence of bladder cancer after
      surgical management. Its side effects are low. This method is of high clinical value.
    

Intervention name(s): Trement
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Bladder neoplasm;; Carcinoma;; Epirubicin;; BCG;; Perfusion
A Dose-response of the Effects of Exendin-9,39 on GI Symptoms and Food Intake
Condition: Obesity; Diabetes; Roux-en-Y Gastric Bypass
Study type: Interventional
Phase: Phase 1

Summary: 
      Exendin-(9,39) has been shown to have effects on beta-cell function, and after gastric
      bypass, to accelerate gastrointestinal transit. - infused at rates of 300pmol/kg/min. Given
      that gastrointestinal transit is typically delayed by Glucagon-Like Peptide-1 (GLP-1) and
      also that this hormone causes decreased food intake through increased satiation, it is
      reasonable to expect an effect of Exendin-9,39 on appetite. This may help explain the effects
      of gastric bypass on food intake. To examine the effect of Exendin on food intake we propose
      a dose-response study to determine whether the compound has effects in a dose-dependent
      fashion. We will examine the presence of gastrointestinal symptoms as well as food intake in
      the immediate aftermath of a test meal and the subsequent hours.
    


Intervention name(s): Exendin-9,39; Saline
Intervention type(s): Drug; Other
Intervention description(s): use Exendin-9,39 @ 750pmol/kg/min and Exendin-9,39 @ 300pmol/kg/min to block endogenous GLP-1 in humans after gastric bypass and determine contribution of GLP to satiety after meal ingestion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Phase IIa Study to Investigate the Efficacy and Safety of SPP635 in Diabetic and Hypertensive Patients With Albuminuria
Condition: Hypertension; Type II Diabetes Mellitus
MeSH terms: Albuminuria; Hypertension; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II a, double-blind, randomized, parallel-design, four-week study to
      investigate the efficacy, safety and tolerability of two different doses of SPP635 in type II
      diabetic patients with mild to moderate hypertension and albuminuria.

      The total study duration for patients completing the entire study will be approximately 7
      weeks including a 2 weeks Screening Phase, 1 week Wash-out Phase, 4 week Treatment Phase and
      1 week Follow-up Phase.

      All treatments other than certain antihypertensive drugs (which are to be washed-out) with an
      effect on BP and all antidiabetic treatments must be kept at stable dose during the whole
      study.

      A maximum of 50 patients in total is planned to be enrolled.
    


Intervention name(s): SPP635
Intervention type(s): Drug
Intervention description(s): oral once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
GLPG0259 Solid Formulation Bioavailability and Food Effect
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to compare the pharmacokinetics of GLPG0259 as a solid dosage
      formulation (with and without food)and an oral solution, and to assess its safety and
      tolerability.
    


Intervention name(s): GLPG0259 solution; GLPG0259
Intervention type(s): Drug; Drug
Intervention description(s): single oral dose, GLPG0259, 50 mg oral solution; single oral dose, GLPG0259, 50 mg solid formulation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Safety; Tolerability; Pharmacokinetics
Study to Determine the Effect of the Timing of a Meal on the Pharmacokinetics of Entinostat
Condition: Volunteers; Healthy Volunteers; Human Volunteers; Normal Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study are to evaluate the effect of the timing of a moderate-fat meal
      on the single dose pharmacokinetics of entinostat and to evaluate the safety and tolerability
      of entinostat under fed and fasting conditions in healthy adult subjects.
    

Detailed description: 
      This is a 2-stage food effect (timing of the meal) study. A total of 48 subjects will be
      dosed if Stage 2 is conducted.

      Stage 1 will be conducted as an open-label, randomized, 2-way crossover study. On Day 1 of
      each period, subjects will receive a single, oral dose of entinostat under fasting or fed
      conditions.

      If preliminary results in Stage 1 indicate that the timing of a meal exhibits significant
      effect on the bioavailability of entinostat, then Stage 2 will be conducted which will
      investigate the effect of a meal either before or after dosing of entinostat on entinostat
      PK.

      Stage 2 will be conducted as an open-label, randomized, 3-way crossover study. On Day 1 of
      each period, subjects will receive a single, oral dose of entinostat under fasting or fed
      conditions.
    

Intervention name(s): Entinostat
Intervention type(s): Drug
Intervention description(s): HDAC (histone deacetylase) inhibitor
Other intervention name(s): SNDX-275; MS-275
Intervention MeSH terms: Entinostat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: entinostat; Histone Deacetylase Inhibitor; HDAC
A Study To Evaluate The Dose-Related Efficacy and Safety of PS433540 in Subjects With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to learn which doses of PS433540 should be given to patients
      with high blood pressure to lower their blood pressure. This study will also examine how safe
      PS433540 is when taken by patients with high blood pressure. Approximately 720 patients will
      be evaluated so that about 375 patients will be entered into the treatment phase of the study
      and be given PS433540.
    


Intervention name(s): irbesartan; placebo; PS433540; PS433540; PS433540
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 300 mg (2 x 150 mg capsules) once daily for 12 weeks; placebo capsules once daily for 12 weeks; 200 mg (2 x 100 mg capsules) once daily for 12 weeks; 400 mg (4 x 100 mg capsules) once daily for 12 weeks; 800 mg (8 x 100 mg capsules) once daily for 12 weeks
Other intervention name(s): Avapro
Intervention MeSH terms: Irbesartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hypertension; High Blood Pressure
Efficacy & Safety of ViaDerm-hPTH(1-34) Compared to Forteo SC in Postmenopausal Women With Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the clinical efficacy, safety, and tolerability of
      ViaDerm-shPTH [1-34] transdermal delivery in comparison to subcutaneous injection of
      rhPTH[1-34] following 3-month treatment in postmenopausal women with Osteoporosis
    


Intervention name(s): Teriparatide
Intervention type(s): Drug
Intervention description(s): Daily for 96 days
Other intervention name(s): Forteo; Forsteo; LY333334
Intervention MeSH terms: Teriparatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoporosis; Transdermal; hPTH(1-34)
A Study of an Oral Nutrition Supplement (ONS) in Children.
Condition: Growth
Study type: Interventional

Summary: 
      To assess the effect of oral nutritional supplementation with dietary counseling versus
      dietary counseling alone on growth of preschool children over a period of 90 days.
    


Intervention name(s): Nutrition supplement + dietary counseling; Dietary Counseling
Intervention type(s): Other; Other
Intervention description(s): Nutritionally balanced nutritional supplement providing 1.0 kcal/ml.; Dietary counseling provided at each study visit by study dietitian.
Other intervention name(s): Commercially available nutritional supplement.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
The Aging Endocrine Pancreas: Characterization of the Entero-insular Axis Physiology in the Elderly
Condition: Diabetes Mellitus, Type 2; Insulin Resistance
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Observational

Summary: 
      Like most endocrine axes, the entero-insular axis is expected to go through an age-related
      physiological deterioration, what might contribute to special features of the elderly onset
      type 2 diabetes in comparison to middle-age.

      Twenty four NGT volunteers will be evaluated by a meal tolerance test (MTT) for incretin
      hormone measurements, and by the hyperglycemic clamp followed by an arginine test for
      assessing the beta-cell function and the acute insulin response. Others parameters as body
      composition and basic biochemistry will be also evaluated at Laboratory of Investigation on
      Metabolism and Diabetes - LIMED / State university of Campinas, Brazil.

      The characterization of the glucagon-like peptide-1 (GLP-1) production, dipeptidyl peptidase
      IV (DPP-IV) activity and/or endocrine pancreas incretin-response at aging, might be an
      interesting evidence to reinforce an incretin-based therapeutic approach for elderly onset
      type 2 diabetes.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adult normoglycemic subjects
      
Biospecimen description: 
      Sera and plasma
    
Keywords: diabetes mellitus, type 2; Insulin resistance; Aging; Incretins; DPP-IV protein, human; Glucagon-Like Peptide 1; Gastric Inhibitory Polypeptide; insulin; glucagon; ghrelin