bioihbjkbjnl/mcl2 huggingface dataset:
A Healthy Volunteer Study to Evaluate for a Single Dose of 4 Different Tablets of DPOC-4088 the Absorption and Elimination From the Body and the Potential Effect on Blood Clotting
Condition: Deep Vein Thrombosis Leg
MeSH terms: Thrombosis; Venous Thrombosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a study existing of 4 periods, to evaluate for a single dose of 4 different
      tablets of DPOC-4088 the absorption and elimination from the body and the potential effect on
      blood clotting. The differences between the tablets are the dose (100 or 200 mg) and the rate
      of release of DPOC-4088 from the tablet (16 or 20 hours). The allocation of the tablets in
      each period will be determined by chance but is known upfront.
    

Detailed description: 
      This will be a randomized, open-label, single oral dose study. The 4-period crossover study
      will determine and compare the PK and PD profiles of DPOC-4088 when administered as a single
      oral dose of 100 mg and 200 mg of DPOC-4088 in two prolonged release formulations (16 and 20
      hr) in 12 evaluable young healthy male subjects.

      Each subject (in a fasting state) will receive each of the 4 treatments (A, B, C, and D) in a
      balanced, 4-period crossover design. Each treatment consists of a single oral dose of 100 mg
      or 200 mg of DPOC-4088 in either prolonged release formulation (16 or 20 hr). Subjects will
      arrive at the study unit for an overnight fast of at least 10 hrs the evening before each
      dosing period and remain in the unit for at least 24 hrs after dosing. Standard meals will be
      provided and subjects will receive their first meal after dosing at 4 hrs post-dose. Blood
      samples will be drawn for PK and PD evaluations immediately prior to dosing and at specified
      time intervals for 48 hrs post-dosing. Each dosing period will be separated by at least a
      5-day washout period that is preferentially not to exceed 10 days.

      In healthy young male subjects, the safety, tolerability, and the PK profile of DPOC-4088
      will be assessed. Additionally, this study will assess the PD profile and the relationship of
      PK/PD in terms of the ability of DPOC-4088 to inhibit thrombin activity (based on
      prolongation of aPTT, ECT, TT and PT).
    

Intervention name(s): DPOC-4088; DPOC-4088; DPOC-4088; DPOC-4088
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A single oral dose of DPOC-4088 prolonged release tablet 100 mg (Formulation A = 16 hr release formulation); A single oral dose of DPOC-4088 prolonged release tablet 200 mg (Formulation A = 16 hr release formulation); A single oral dose of DPOC-4088 prolonged release tablet 100 mg (Formulation B = 20 hr release formulation); A single oral dose of DPOC-4088 prolonged release tablet 200 mg (Formulation B = 20 hr release formulation)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: phase I; healthy volunteers; crossover study; pharmacokinetics; pharmacodynamics
A Comparative Double-Blind, Double- Dummy Study of Desloratadine (DL) 5 MG Once Daily, Cetirizine 10 MG Once Daily, and Placebo Once Daily in Patients With Chronic Idiopathic Urticaria (Study P03735)
Condition: Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Study type: Interventional
Phase: Phase 4

Summary: 
      This was a randomized, double-blind, parallel-group, multicenter study that used both an
      active control (cetirizine) and a placebo control to evaluate desloratadine 5 mg once daily
      during a 28-day treatment period. The active treatments and placebo were allocated in a 2:2:1
      ratio.
    


Intervention name(s): desloratadine; placebo; cetirizine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): desloratadine, 5mg oral tablets, once daily for 28 days; placebo, once daily for 28 days; cetirizine, 10 mg capsules once daily for 28 days
Other intervention name(s): SCH 034117
Intervention MeSH terms: Cetirizine; Desloratadine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Treatment of Critically Ill Patients With Covid-19 With Convalescent Plasma
Condition: SARS-Associated Coronavirus; Covid19; SARS-CoV Infection
MeSH terms: COVID-19; Severe Acute Respiratory Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to collect convalescent plasma and use it as experimental treatment in
      critically ill Covid-19 patients in order to reduce mortality and length of stay in intensive
      care unit.
    

Detailed description: 
      This study aims to use convalescent plasma as experimental treatment in critically ill
      Covid-19 patients in order to reduce mortality and length of stay in intensive care unit.
      Donors must have anti-SARS CoV2 antibodies. Recipients must be critically ill Covid-19
      patients on mechanical ventilation.
    

Intervention name(s): Convalescent plasma
Intervention type(s): Biological
Intervention description(s): Convalescent plasma from patients recovering from Covid-19 and which had anti-SARS-Cov-2 antibodies
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Convalescent plasma; Covid-19 treatment; Transfusion medicine
DIabetic Retinopathy Candesartan Trials
Condition: Type 2 Diabetes
MeSH terms: Diabetic Retinopathy
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective is to determine whether candesartan, compared to placebo reduces the
      progression of diabetic retinopathy in normoalbuminuric type 2 diabetic patients with
      retinopathy.

      The secondary objective is to determine whether candesartan, compared to placebo, reduces the
      incidence of clinically significant macular oedema (CSME) and/or proliferative diabetic
      retinopathy (PDR) and beneficially influences the rate change in urinary albumin excretion
      rate (UAER).

      This study is part of the DIRECT Programme also including a primary prevention study of
      diabetic retinopathy in type 1 diabetes and a secondary prevention study in type 1 diabetes.
      The primary objective for all three pooled studies is to determine whether candesartan,
      compared to placebo, reduces the incidence of microalbuminuria in type 1 and type 2 diabetic
      patients.
    


Intervention name(s): candesartan
Intervention type(s): Drug
Intervention description(s): 32 mg oral tablet
Other intervention name(s): ATACAND
Intervention MeSH terms: Candesartan; Candesartan cilexetil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes mellitus type 2
A Study of DPP-IV Inhibitor in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor in patients
      with type 2 diabetes receiving a stable dose of metformin. The anticipated time on study
      treatment is 3-12 months and the target sample size is 100-500 individuals.
    


Intervention name(s): DPP-IV Inhibitor; Metformin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Escalating doses po bid; As prescribed; po bid
Intervention MeSH terms: Metformin; Dipeptidyl-Peptidase IV Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparison of LY686017 With a Marketed Drug in the Treatment of Social Anxiety Disorder
Condition: Social Phobia
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a Phase 2 trial to test the efficacy of LY686017 in the treatment of Social
      Anxiety Disorder.
    


Intervention name(s): LY686017; paroxetine; placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
The Effects of Anesthetic Techniques and Palonosetron Administration on the Incidence of PONV
Condition: PONV; Palonosetron; Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      The incidence of postoperative nausea and vomiting (PONV) after thyroidectomy have been shown
      to be relatively high compared other surgeries, with a reported incidence 65-75 %. PONV may
      increase patient discomfort, delay patient discharge, and increase the cost of patient care,
      the risk of postoperative bleeding which may potentially cause airway obstruction.

      It is reported that the maintenance of anesthesia with propofol-remifentanil or
      sevoflurane-propofol-remifentanil decreased the incidence of PONV compared sevoflurane alone,
      but failed to demonstrate the decreased incidence of PONV in 6-24 hr postoperative period in
      patients undergoing thyroidectomy. Administration of Palonosetron, newly developed 5-HT3
      antagonists with long half life (48 hrs) may decrease the incidence of PONV particularly
      during this period.

      The purpose of this study was to evaluate and compare the incidence of PONV after
      thyroidectomy with three different anesthetic methods, sevoflurane or
      sevoflurane-propofol-remifentanil or sevoflurane-propofol-remifentanil-palonosetron in woman
      patients.
    


Intervention name(s): Palonosetron; sevoflurane; remifentanil; pentothal sodium; propofol
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): newly developed 5-HT3 antagonists with long half life (48 hrs) intravenous administration prior to anesthesia induction; Inhalational anesthetics Halogenated.; ultra-short acting opioid anesthetics; intra-venous anesthetics for anesthesia induction; intra-venous anesthetics for anesthesia induction and maintenance
Intervention MeSH terms: Remifentanil; Thiopental; Palonosetron; Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
A Randomized Incentive-Based Weight Loss Trial in Singapore
Condition: Obesity; Incentives
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to test the extent to which incentives, when combined with an
      existing evidence-based weight loss program, improve weight loss and weight loss maintenance.
      It will also compare the cost-effectiveness of the incentive-based weight loss programs to
      the basic program without incentives.
    

Detailed description: 
      Globally, the rise in obesity rates has reached epidemic proportions, and in Singapore 53% of
      adults have a body mass index (BMI) great than 23.0 kg/m2, a level that increases risk for
      chronic disease among Asians. This study aims to test the extent to which traditional or
      behavioural economic incentives, when combined with an existing evidence-based weight loss
      program, improve weight loss and weight loss maintenance. Data will be collected through a
      two-arm (basic weight loss program, basic program plus traditional or behavioural economic
      incentives) randomized controlled trial (RCT) where key outcome variables are defined as
      weight loss (kilograms) at 8 months when the incentive program concludes, and at 12 months,
      after a 4 month period in which no additional incentives are provided. We hypothesize that at
      both 8 and 12 months, weight loss will be greater in the incentive arm than in the arm
      without incentives. The growing obesity epidemic, the high costs of obesity to employers,
      insurers and governments across Asia, and the fact that the incentive program is designed to
      be close to cost neutral, suggest that this research has high potential to have a significant
      public health impact, both in Singapore and the region.
    

Intervention name(s): Financial Incentives
Intervention type(s): Other
Intervention description(s): Incentive arm participants will be able to earn incentives for meeting specified weight loss targets or step goals. They will be offered a choice between traditional (payments with certainty) and behavioral(payments paid via lottery) incentives.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Care Provider)
Primary purpose: Health Services Research
Keywords: Obesity; Weight loss; Incentives; Motivation
HOP-2A - Intratesticular Hormone Levels
Condition: Healthy; Male Infertility; Prostate Disease
MeSH terms: Infertility; Infertility, Male; Prostatic Diseases
Study type: Observational

Summary: 
      The purpose of this investigational study is to find out what hormones are present in healthy
      male testicles using fine needle aspiration.
    

Detailed description: 
      We will collect a very small amount of fluid from each testicle. Participation will last up
      to 12 weeks. The study involves a minimum of 4 visits, the screening visit and procedure Day,
      fine needle aspiration of the testes (about 1-1.5 hours each) and two follow-up visits (about
      30-45 minutes). Over the course of the study, you will have a little less than a 1/3-cup of
      blood drawn (roughly 2-3 tablespoons at each visit).
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy males
      
Biospecimen description: 
      serum blood, testicular tissue
    
Keywords: Fine Needle Aspiration; Male Health; Male Contraception
Inflammation-related Alterations in Neurocircuitry: Reversal With Levodopa
Condition: Depression
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to learn more about the changes that happen in the brain and the
      body when a person is depressed. This study will determine if the level of inflammation in
      the body is related to symptoms of depression, how well the person thinks, and how certain
      brain regions communicate.
    

Detailed description: 
      Cytokines released by an activated immune system have been associated with decreased brain
      dopamine and the development of depression. Biomarkers of inflammation, such as inflammatory
      cytokines and acute-phase proteins like C-reactive protein (CRP), are elevated in a
      significant proportion of patients with mood and psychiatric disorders. The investigators
      will study if administration of Levodopa (L- 3,4-dihydroxyphenylalanine [DOPA]-carbidopa,
      250/25mg) to depressed patients with high inflammation will 1) increase corticostriatal
      functional connectivity, and 2) improve objective measures of motivation compared to placebo.
    

Intervention name(s): Levodopa+carbidopa; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sinemet is a combination of 250 mg levodopa and 50 mg carbidopa. Sinemet will be administered orally at Visit 1 or Visit 2.; A placebo is a sugar pill that has no therapeutic effect and will be administered orally at Visit 1 or Visit 2.
Other intervention name(s): Sinemet
Intervention MeSH terms: Levodopa; Carbidopa
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Inflammation; Anhedonia; Psychomotor retardation
Cocoa Extract-enriched Meals and Cardiovascular Risk in Older Population
Condition: Cardiovascular Risk Factors
Study type: Interventional

Summary: 
      Obesity prevalence in elderly populations has increased in the last years, and the reduction
      of overweight and obesity is a priority target in populations of all age ranges worldwide.
      Obesity is a disease frequently accompanied by a pro-inflammatory state, in which metabolic
      functions may be compromised, and therefore there is a risk of developing comorbidities such
      as type-2 diabetes, hyperlipidemias, hypertension, atherosclerosis, etc. In this context,
      plant extracts are a good source of antioxidant compounds. Among these compounds, polyphenols
      have been shown to have an important antioxidant effect. Scientific evidence based on
      epidemiological studies suggest that flavonoids from the diet play an important role on the
      prevention of cardiovascular disease. Cocoa and related products are an important source of
      flavonoids, providing even more than tea or wine. Generally, benefits associated to cocoa
      consumption are related to the ability for improving lipid profile and insulin sensitivity,
      reducing blood pressure, platelet activity and improving endothelial dysfunction. Some
      studies have also shown an improvement of inflammatory conditions, mainly due to the capacity
      of the polyphenols contained to modify cellular transcription, and the secretion of
      proinflammatory cytokines in peripheral blood mononuclear cells, macrophages and lymphocytic
      strains. Therefore, the hypothesis of this study is that the consumption of cocoa
      extract-enriched prepared meals, within a hypocaloric diet, will help to reduce body weight
      and to improve cardiovascular risk factors compared to the same diet with standard prepared
      meals.
    


Intervention name(s): Cocoa extract
Intervention type(s): Dietary Supplement
Intervention description(s): Participants will follow a hypocaloric diet during two periods of 4 weeks, each. Within these diets, participants will consume daily 2 ready prepared frozen meals containing cocoa extract (0.7 g per meal; 1.4g per day) or nothing (placebo).
Other intervention name(s): Ready prepared meals; bioactive ingredients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: cardiovascular risk; Elderly population; cocoa extract; overweight and obesity; Glycemic profile; lipid profile; antioxidant status; inflammatory state; Cardiovascular Risk factors in elder population
Cognitive Behavior Group Therapy in Adolescents With Attention Deficit Hyperactivity Disorder
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      Attention Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder which starts
      in childhood and is characterized by symptoms of attention deficit, hyperactivity and
      impulsivity. Persistence into adolescence is frequently associated with among other low
      educational achievement, interpersonal difficulties, anxious and depressive symptoms and
      sleep problems. Treatment guidelines recommend psychological treatment as part of the
      treatment plan, however compared to children and adults, there is still a substantial lack of
      knowledge about appropriate psychological treatment in adolescents. The present study
      examines a psychological intervention for adolescents with ADHD, cognitive behavior group
      therapy. The intervention consists of 12 weekly cognitive behavioral therapy sessions
      addressing core difficulties and concerns of the adolescent population with ADHD. The
      investigators wish to determine the efficacy of group therapy in adolescents with ADHD who
      receive medical treatment but still have impairing ADHD symptoms.
    

Detailed description: 
      Change February 1st 2017: Inclusion of patients with mild to moderate behavioral problems in
      order to achieve enough participants in the study.

      Change February 1st 2017: The study primarily recruits patients who are on pharmacological
      treatment for ADHD. However, for ethical reasons and in order to achieve enough participants,
      the study will also recruit patients who have not responded to at least two drug trials or
      have been unable to continue pharmacological treatment because of intolerable side effects.

      Change February 1st 2018: The Weiss Functional Impairment Rating Scale, Rosenberg and BRIEF
      questionnaires will not be collected at the 9-month follow-up due to lack of resources
      (project assistance).
    

Intervention name(s): cognitive behavior group therapy; Treatment as usual
Intervention type(s): Behavioral; Other
Intervention description(s): 1,5 hours weekly session during 12 weeks, 8 participants, 2 therapists.; Education on ADHD, and ADHD medication if indicated
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Behavior Therapy; Cognitive Therapy; Adolescents; Psychotherapy, Group
Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Skin Infections
Condition: Infections, Pediatrics
MeSH terms: Infections; Communicable Diseases
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a study of safety, effectiveness, blood levels and tolerance of Ceftaroline fosamil
      in children with skin infections receiving antibiotic therapy in the hospital.
    

Detailed description: 
      To evaluate safety, effectiveness, pharmacokinetics and tolerance of Ceftaroline fosamil in
      children who are initially hospitalized with Acute Bacterial Skin and Skin Structure
      Infections (ABSSSI).
    

Intervention name(s): Ceftaroline fosamil; Vancomycin +/- Aztreonam or Cefazolin +/- Aztreonam; Cephalexin or Clindamycin or Linezolid
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects ≥ 6 months old: 12 mg/kg IV for subjects weighing ≤ 33 kg and 400 mg for subjects weighing > 33 kg will be infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour)
Subjects < 6 months old: 8mg/kg infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour); Vancomycin 15mg/kg IV over 60 minutes (or a maximum of 10mg/min whichever is longer) +/- Aztreonam 30 mg/kg IV every 8 hours over 60 minutes (for infections involving gram negative pathogen suspected or confirmed)
Cefazolin 75mg/kg IV divided every 8 hours over 60 minutes (for sites that do not empirically cover for MRSA) +/- Aztreonam 30 mg/kg IV every 8 hours over 60 minutes (for infections involving gram negative pathogen suspected or confirmed; Possible oral switch on or after study day 4.
Cephalexin: 25 mg/kg q6h PO or Clindamycin: 10 mg/kg q8h PO or Linezolid 600mg q12h (cohort 1) or 10 mg/kg q8h (cohorts 2,3 and 4) PO.
Other intervention name(s): Teflaro; PPI-0903; TAK-599; TAK599; PPI0903
Intervention MeSH terms: Vancomycin; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Cefazolin; Linezolid; Cephalexin; Ceftaroline fosamil; Aztreonam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Infections; Pediatrics; Teflaro; cephalosporin