bioihbjkbjnl/mcl2 huggingface dataset:
SECOTEX® (Tamsulosin Hydrochloride) Bioequivalence Study Brazil - Fast Admin
Condition: Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 1

Summary: 
      It will be an open-label, randomized, laboratory-blind, crossover study with 02 treatments,
      02 sequences, and 02 periods, in which the healthy male volunteers under fasting conditions
      receive, in each period, the test formulation or the reference formulation
    

Detailed description: 
      TITLE: Randomized, two-period, cross-over, bioequivalence study on tamsulosin hydrochloride
      0,4 mg prolonged release hard gelatin capsule (Synthon BV, The Netherlands) versus SECOTEX®
      (tamsulosin hydrochloride) 0,4 mg prolonged release hard gelatin capsule (Boehringer
      Ingelheim do Brasil Química e Farmacêutica Ltda) in healthy male volunteers under fasting
      conditions.

      It will be an open-label, randomized, laboratory-blind, crossover study with 02 treatments,
      02 sequences, and 02 periods, in which the healthy male volunteers under fasting conditions
      receive, in each period, the test formulation or the reference formulation.

      The treatment's sequence attributed to each volunteer on the study period is determined by a
      randomization list, which is generated by PROC PLAN from SAS version 9.1.3 system.

      The formulations will be administered as a single oral dose followed by blood collections
      between, at least, 3 to 5 half-lives. The treatment's periods may obey a minimum interval of
      7 half lives between them (period for drug's whole elimination by the organism).
    

Intervention name(s): Test formulation; Reference formulation
Intervention type(s): Drug; Drug
Intervention description(s): tamsulosin hydrochloride 0,4 mg (Synthon BV); tamsulosin 0,4 mg (Boehringer Ingelheim)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence; Tamsulosin; Healthy volunteers; Fast conditions
Effect of Pursed Lips Breathing on Chest Wall, Mobility Diaphragmatic and Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      This study aimed to evaluate the acute effect of PLB technique on diaphragmatic mobility, the
      kinematics of the thoracoabdominal complex analysis of lung volumes and exercise tolerance in
      patients with Chronic Obstructive Pulmonary Disease (COPD). This is a study randomized
      cross-over clinical trial and blind, in subjects with Chronic Obstructive Pulmonary Disease
      (COPD) according to criteria of the Global Initiative for Chronic Obstructive Lung Disease
      (GOLD) (FEV1 / FVC <0.7 and FEV1 <80% predicted) selected at the Clinical Hospital of the
      Federal University of Pernambuco (UFPE) and Otavio de Freitas General Hospital (HGOF). The
      investigators recruited 13 patients COPD (according to previous sample calculation) aged
      between 40 and 80 years, of both sexes. The first day was held evaluation of lung function,
      respiratory muscle strength, body composition, dyspnea index and functional capacity. On the
      second day was held evaluation of thoracoabdominal complex kinematics by plethysmography
      Optoelectronics (OEP) with Quiet Breathing (QB) or pursed-lips breathing (PLB). Lung volumes
      with 2 minutes with QB and 6 minutes PLB or only 6 minutes by QB as randomization were
      observed. Before and after performing the requested breathing pattern diaphragmatic mobility
      was observed by Ultrasonography (US) and requested the patient an Inspiratory Capacity
      maneuver (IC). The evaluator who performed the ultrasound was blinded as to the beginning of
      the breathing pattern of order performed by the patient.
    


Intervention name(s): Pursed Lips Breathing; Quiet Breathing
Intervention type(s): Other; Other
Intervention description(s): Pursed Lips Breathing for six minutes.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Chronic Obstructive Pulmonary Disease; Respiratory mechanics; Plethysmography; Diaphragm; Respiratory muscles; Breathing exercises
Safety, Tolerability, and Immunogenicity of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-005)
Condition: Bacterial Infections; Virus Diseases
MeSH terms: Infections; Bacterial Infections; Virus Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study to assess the safety, tolerability, and immunogenicity of V419 (PR5I) when
      administered as an infant series at 2, 4, and 6 months of age followed by a toddler dose of
      DAPTACEL™, Prevnar 13™ and PedvaxHIB™ at 15 months of age. The study will determine whether
      subjects who receive V419 have a similar immune response to the vaccine compared to subjects
      who receive licensed component vaccine controls.
    


Intervention name(s): V419; DAPTACEL™; PedvaxHIB™; Prevnar 13™; RotaTeq™; PENTACEL™; Recombivax HB vaccine; ActHIB™
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): V419 (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Outer Membrane Protein Complex], and Hepatitis B [Recombinant] Vaccine) 0.5 mL intramuscular injection at 2, 4, and 6 months of age; DAPTACEL™ 0.5 mL intramuscular injection at 15 months of age; PedvaxHIB™ 0.5 mL intramuscular injection at 15 months of age; Prevnar 13™ 0.5 mL intramuscular injection at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; PENTACEL™ 0.5 mL intramuscular injection at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL intramuscular injection at 2 and 6 months of age; ActHIB™ 0.5 mL intramuscular injection at 15 months of age
Other intervention name(s): V260
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diphtheria; Tetanus; Whooping Cough (pertussis); Poliomyelitis; Hepatitis B infection; Haemophilus influenzae type b infection
A Study to Assess Bioequivalence of a New Tapentadol Extended-Release Tablet With Respect to a Tapentadol Extended Release Tablet Under Fasted Conditions in Healthy Subjects
Condition: Healthy
MeSH terms: Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate bioequivalence (biological equivalence of two
      formulations of a study medication) of a new tapentadol Extended release (ER) 100 mg
      tamper-resistant formulation (TRF) tablet, to the current tapentadol ER 100 mg,
      prolonged-release formulation 2 (PR2) tablet used in healthy participants under fasted
      (without food) conditions.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), randomized (the
      study medication is assigned by chance), 2-way crossover (method used to switch participants
      from one treatment arm to another in a clinical study), single-dose, and single-center study.
      The study consists of 3 phases: the screening phase, treatment phase, and end-of-study or
      withdrawal assessment phase. In the treatment phase, participants will receive a single dose
      of new tapentadol ER 100-mg TRF tablet (Treatment A) and current tapentadol ER 100-mg PR2
      (Treatment B) under fasted conditions in 2 treatment sequences (AB and BA). Administration of
      the study medication will be separated by a washout period (no treatment) of 7 to14 days.
      Approximately 64 participants will be enrolled in this study. Safety will be evaluated by the
      assessment of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and
      physical examination. The duration of participation in the study for an individual
      participant will be approximately 5.5 weeks.
    

Intervention name(s): Tapentadol Extended Release (ER) Tamper-Resistant Formulation (TRF); Tapentadol Prolonged-Release Formulation 2 (PR2)
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive a single dose of tapentadol ER TRF 100 mg tablet orally (by mouth) in treatment sequences AB and BA appropriately.; Participants will receive a single dose of tapentadol PR2 100 mg tablet orally in treatment sequences AB and BA appropriately.
Intervention MeSH terms: Tapentadol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Tapentadol; Tapentadol extended-release tamper-resistant formulation; Tapentadol extended-release prolonged-release formulation; Bioequivalence; Fasted Conditions
LEO 32731 for the Treatment of Moderate to Severe Psoriasis Vulgaris
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      A study of LEO 32731 in the treatment of psoriasis vulgaris
    

Detailed description: 
      This is an investigation of the efficacy of LEO 32731 30 mg as compared to placebo after 16
      weeks of oral treatment of psoriasis vulgaris
    

Intervention name(s): LEO 32731; LEO 32731 Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Psoriasis
Combined Effects of Early Behavioral Intervention and Propranolol on ASD
Condition: Autism
Study type: Interventional

Summary: 
      The purpose of this study is to explore the effects of propranolol in combination with early
      intensive behavioral intervention on social interaction, and secondarily on language,
      anxiety, adaptive behaviors, and global function in children with autism in a double-blinded,
      placebo-controlled pilot trial.
    

Detailed description: 
      The investigators' specific aim is to examine the effects of serial doses of propranolol in
      combination with early intensive behavioral intervention on social interaction, and
      secondarily on language tasks, anxiety, adaptive behaviors, and global function in children
      with autism in a double-blinded, placebo-controlled trial. The investigators will also
      examine whether response to treatment can be predicted based upon markers of autonomic
      functioning, such as pupillary light reflex and heart rate variability, and whether anxiety
      predicts treatment response. The investigators' hypothesis is that propranolol will augment
      the effects of behavioral therapy on social functioning and language abilities. The
      investigators have demonstrated benefits of propranolol on social functioning and language in
      previous single-dose studies in adults and adolescents with autism. The investigators also
      predict that those with the greatest degree of autonomic dysregulation will demonstrate the
      greatest benefit from the drug.
    

Intervention name(s): Propranolol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participant will receive Propranolol prior to each EIBI session; Participant will receive placebo prior to each EIBI session
Other intervention name(s): Inderal
Intervention MeSH terms: Propranolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
ITF2984 Repeated Doses Study in Healthy Volunteers
Condition: Healthy Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a within group, randomised, repeated dose, placebo- and octreotide controlled study
      in a target population of 45 healthy male subjects. Subjects were required to attend the
      clinical for screening procedures between 3 and 28 days before dosing commenced. The study
      was conducted in 4 groups of subjects; Groups 1 to 3 were a double-blinded, randomised
      design, each consisting of 12 subjects. Group 4 was an open-label design and consisted of 9
      subjects. There was a minimum interval of 96 h between dosing of Groups 1, 2 and 3 to allow
      for interim analyses of PK and safety/tolerability data for dose escalation purposes. Group 4
      (the active control group) was still to proceed if the decision was taken to prematurely stop
      dosing with ITF2984 (somatostatin analogue) following review of the PK and safety data
      presented at the interim decision meeting; dosing of this group was conducted independently
      from Groups 1 to 3. On Days 1 to 6, subjects in Groups 1 to 3 were to receive 2 doses of
      investigational medicinal product (IMP) approximately 12 h apart; subjects in Group 4 were to
      receive 3 doses of IMP approximately 8 h apart. For all groups, subjects were scheduled to
      receive their final dose of IMP on the morning of Day 7.

      In addition, subjects were to receive exogenous test administrations(stimulation test) on Day
      -1, Day 1 and Day 7 at the same time on each day (ie for Day -1, 23.5 h before the first dose
      of IMP, and for Days 1 and 7, 0.5 h after the first dose of IMP on the respective day). Blood
      samples for PD and PK analyses were taken at specified time points after each dosing.

      Subjects remained on site for 10 days (ie 36 h after the final dose of IMP on Day 7)
      providing that discharge conditions had been met, and returned to the clinic between 5 and 10
      days after the last IMP administration for a follow-up visit.
    


Intervention name(s): ITF2984 (500, 1000, 2000 mcg bid for 7 days); octreotide 50 mcg tid; Placebo
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): somatostatin analogue
Intervention MeSH terms: Octreotide; Somatostatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Therapeutic Efficacy of Phytosterols on Metabolic Syndrome
Condition: Metabolic Syndrome x
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The objective is to evaluate therapeutic efficacy of 2 grams nano-phytosterols daily
      supplemention on diagnosis criteria of metabolic syndrome.
    


Intervention name(s): Phytosterols; Titanium Dioxide
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Oral daily consumption of 2 grams of phytosterols (8 ml) per 180 days.; Oral daily consumption of Titanium Dioxide (8 ml) per 180 days.
Other intervention name(s): Cardiosmile
Intervention MeSH terms: Titanium dioxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
eKISS: Electronic KIOSK Intervention for Safer-Sex
Condition: Reproductive Behavior; Contraception; Sexually Transmitted Diseases
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional

Summary: 
      This study is a randomized controlled trial to test acceptability, feasibility and
      preliminary efficacy of an interactive computer-based intervention with individualized
      feedback to promote sexual health in adolescents and young adults with assessment of
      behavioral and biomarker outcomes.
    

Detailed description: 
      This study is a randomized controlled trial to test acceptability, feasibility and
      preliminary efficacy of an interactive computer-based intervention (ICBI) with individualized
      feedback to promote sexual health in adolescents and young adults. The intervention uses
      physician avatars and uses elements of motivational interviewing to elicit sexual risk
      behaviors and motivation to change risky behavior. Feedback includes instructive video
      modules. Participants were asked to identify one behavior to change and were reassessed at
      3-month follow-up for interim sexual behavior including condom and birth control use.
      Participants were tested for chlamydia, gonorrhea, and pregnancy(females) at baseline and
      3-month follow-up.
    

Intervention name(s): eKISS: electronic KIOSK for Safer-Sex
Intervention type(s): Behavioral
Intervention description(s): An interactive computer-based intervention for safer-sex which provides individualized feedback about protective and risky sexual behaviors; offers instructive video modules for safe-sex; elicits change behavior and identification of behavior change goal using elements of motivational interviewing.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: reproductive health, condoms, sexually transmitted diseases, contraception
Study to Explore the Effects of Two Hour Inhalation of Ultrafine Carbon Black Particles on Airway Inflammation in Asthmatics
Condition: Asthma
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The aim of the study is to test the hypothesis that the allergic airway inflammation in
      asthmatic patients will be enhanced after exposure to ultrafine particles (UFP). In order to
      test this in a controlled study, the researchers combine controlled exposure to carbon black
      model UFP with the well-established model of a segmental allergen challenge, which allows the
      researchers to safely induce circumscript allergic inflammation in the lung in mild
      asthmatics. The effect of the UFP on allergic inflammation will be controlled by an
      inhalation of clean air in a randomized, double-blind, crossover design.
    


Intervention name(s): Bronchoscopy; Exposure to ultrafine carbon black particles
Intervention type(s): Procedure; Other
Intervention description(s): bronchoscopy with segmental allergen challenge; Exposure to ultrafine carbon black particles for 2 hours
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Asthma GINA 1
Can Tailored Patient Letters Improve The Quality Of Diabetic Patient Care?
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this study is to determine if tailored letters sent to diabetic patients will
      improve care of diabetes.
    

Detailed description: 
      Diabetes care in the US is less than optimal. Some authors have found that targeted patient
      letters are also an effective tool to improve outcomes when they are part of a comprehensive
      disease management plan. Local patient satisfaction surveys had revealed that many patients
      had sub-optimal understanding of diabetes measures and of the importance of controlling these
      measures to reduce diabetic complications. We wondered if tailored patient letters and
      enclosed lab orders when due might increase patient awareness of diabetes measures and
      increase patient engagement.We hypothesized that the addition of targeted patient letters
      with enclosed lab orders to an ongoing performance improvement program would further improve
      diabetes care.

      We conducted a randomized controlled study of tailored patient letters and diabetes lab
      orders at our two resident-based clinics.
    

Intervention name(s): Tailored letter
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Diabetes Mellitus targeted mailing
Addition of Cisplatin to Neoadjuvant Therapy for T Locally Advanced Breast Cancer
Condition: Tubular Breast Cancer; Mucinous Breast Cancer; Invasive Ductal Breast Cancer; Inflammatory Breast Cancer
MeSH terms: Breast Neoplasms; Inflammatory Breast Neoplasms; Carcinoma, Ductal, Breast
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators hypotheses that paclitaxel combined with cisplatin in a weekly-based
      regimen as neoadjuvant chemotherapy is effective and tolerable for locally advanced breast
      cancer.
    

Detailed description: 
      In this trial, all the patients will have weekly paclitaxel and cisplatin as neoadjuvant
      chemotherapy for 4 cycles. Patients with Her2 positive tumor will also receive the
      trastuzumab.
    

Intervention name(s): Paclitaxel; Cisplatin
Intervention type(s): Drug; Drug
Other intervention name(s): Taxol
Intervention MeSH terms: Paclitaxel; Cisplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of HTD1801 in Adults With Nonalcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)
Condition: Fatty Liver, Nonalcoholic; NAFLD; Nonalcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis; Digestive System Diseases; Type 2 Diabetes Mellitus (T2DM)
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Digestive System Diseases; Gastrointestinal Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      Randomized, double-blind, placebo-controlled, parallel-group study comparing multiple doses
      of HTD1801 to placebo.
    

Detailed description: 
      This 18-week randomized, double-blind, parallel-group, proof of concept (POC), dose-ranging
      study compared multiple doses of HTD1801 to placebo in a 1:1:1 ratio. Since accumulation of
      hepatic fat is considered the "first hit" in the pathogenesis of NASH (Adams and Angulo
      2006), change in liver fat content (LFC) by magnetic resonance imaging estimated proton
      density fat fraction (MRI-PDFF) is an appropriate primary endpoint and is consistent with
      that used in other recent Phase 2 POC studies in NASH (Harrison et al., 2018, Madrigal
      Pharmaceuticals 2018).

      The Harrison et al., 2018, Madrigal Pharmaceuticals 2018 study showed clinically meaningful
      absolute and relative reductions in LFC assessed by MRI-PDFF over 12-week treatment periods
      thus, it was considered that an 18 week HTD1801 treatment period would therefore be adequate
      to assess the study's primary endpoint and to maximize collection of exposure and safety
      related data.
    

Intervention name(s): HTD1801; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): HTD1801 tablets, 250mg; tablets manufactured to mimic HTD1801 tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment