bioihbjkbjnl/mcl2 huggingface dataset:
A Phase III Efficacy Study of the Symptomatic Treatment of Seasonal Allergic Rhinitis With Bilastine
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the study was to determine the efficacy and tolerability of 20 mg of
      Bilastine, compared to Desloratadine and placebo for the treatment of Seasonal Allergic
      Rhinitis.
    

Detailed description: 
      Pivotal, double-blind, randomized, placebo-controlled, comparative with desloratadine,
      parallel group, international, multicenter study.The Primary endpoint was the Change in total
      reflective score on the scale of symptoms associated with seasonal allergic rhinitis
      indicated by patients at the baseline assessment and over the 2 weeks of the study. A total
      of 720 patients with seasonal allergic rhinitis were enrolled. Duration of treatment was 14
      days, preceded by one week (7 days) of placebo.
    

Intervention name(s): Bilastine; Desloratadine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 20 mg (encapsulated) tablets QD/14 days; 5 mg (encapsulated) tablets QD/14 days; (encapsulated) Tablets QD/14 days
Other intervention name(s): Aerius
Intervention MeSH terms: Desloratadine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rhinitis; Allergic; Seasonal; Hay Fever; Pollen Allergy; Pollinosis; Rhinoconjunctivitis; Sneezing; Nasal itching; Nasal Congestion; Rhinorrhea; Ocular itching; Ocular redness; Tearing
Safety and Pharmacodynamic Study of CD-NP
Condition: Heart Failure, Congestive
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to establish the safety of CD-NP in normal human
      volunteers.
    

Detailed description: 
      The study will be conducted in two phases. The first phase, "ascending dose phase", will be
      an open-label study in cohorts of four (4) subjects (entered two subjects at a time) with the
      primary objective of establishing the safety of CD-NP. The second phase, "MTD confirmation
      phase", will be conducted under randomized, double-blind, placebo-controlled conditions in a
      larger cohort of subjects (10 subjects). The primary objective of this phase will be to
      confirm the safety and pharmacodynamic findings at the apparent MTD.

      Secondary objectives include evaluation of the effect of CD-NP on: mean arterial pressure
      (MAP), heart rate (HR), urinary sodium and potassium excretion (UNaV and UKV, respectively),
      urinary flow rate (UV), and creatinine clearance. Plasma concentrations of CD-NP, angiotensin
      II, and aldosterone, and the urinary excretion rates of cGMP and CD-NP will also be
      determined.
    

Intervention name(s): CD-NP
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Safety; Heart Failure
Safety,Tolerability and Pharmacokinetics of Multiple Ascending Doses of VCH 916 in Subjects With Chronic Hep C Infection
Condition: HCV Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether a 3-day course of therapy with orally
      administered VCH-916 given at different dosages can effectively reduce the amount of
      circulating virus (i.e., viral load) in patients with early-stage chronic hepatitis
      C-infection. This study will also evaluate the safety and tolerability of treatment with
      VCH-916. Blood samples will also be taken to measure the levels of VCH-916 present in plasma
      at various time points during the treatment period.
    


Intervention name(s): VCH 916; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dose escalation study with a full review of all safety data following each cohort.; Dose escalation study with a full review of all safety data following each cohort.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Cognitive Behavior Therapy and Habit Reversal Training for the Treatment of Chronic Tic Disorders in Children
Condition: Tourette Syndrome; Tic Disorders
MeSH terms: Tourette Syndrome; Tics; Tic Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will determine the effectiveness of cognitive behavior therapy (CBT) with habit
      reversal training (HRT) in treating chronic tic disorders (CTDs) in children and adolescents.
    

Detailed description: 
      CTDs and Tourette syndrome are neurobehavioral disorders that are characterized by a
      persistent pattern of motor and vocal tics. Tics are intermittent movements or sounds that
      occur repeatedly. They can be either brief, rapid, and darting movements or more purposeful
      movements, such as repetitively locking and unlocking a door. Vocal tics can be simple, as in
      sniffing or grunting, or more complex, such as complete words or phrases. Tic disorders can
      cause considerable distress in affected children, and can lead to social and academic
      impairment. If left untreated, CTDs can last into adulthood. The standard treatment for
      suppressing CTDs is medication; dopamine-blocking drugs are used most commonly. These
      medications, however, are associated with a range of adverse effects that can result in poor
      treatment compliance and premature treatment termination. Recent research suggests that HRT
      may be an effective, lower risk treatment for CTDs. HRT is a behavioral treatment based on
      increasing awareness of one's behaviors and replacing unwanted behaviors with less bothersome
      ones. This study will determine the effectiveness of CBT with HRT in treating CTDs in
      children and adolescents.

      Participants in this double blind study will be randomly assigned to receive either CBT plus
      HRT or standard care, which will consist of psychoeducation and supportive therapy. All
      participants will partake in 8 sessions of their assigned therapy over the course of 10
      weeks. After the initial 10 weeks, those who responded to treatment will report back to the
      study site for 3 monthly booster sessions. Changes in tic severity, effects of the therapies
      on overall functioning and quality of life, and possible predictors of treatment outcome will
      be assessed.
    

Intervention name(s): Comprehensive Behavioral Intervention for Tics
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Chronic tic disorder; Motor tics; Vocal tics
Metabolic Causes of Thrombosis in Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes
MeSH terms: Thrombosis; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to learn more about why patients with diabetes have increased
      heart attacks, strokes and other illnesses due to blood clots causing blockage of a blood
      vessel. The proposed protocol will study the separate and combined effects of high glucose
      and high fats on certain cardiovascular responses in Type 2 DM.
    

Detailed description: 
      Currently 75-80% of diabetes mellitus (DM) patients die due to thrombotic causes. Data from
      the Centers for Disease Control and Prevention released in 2000 indicated that mortality due
      to coronary artery disease is decreasing except in individuals with diabetes. Clearly the
      disordered metabolism, which includes abnormal metabolism of fats resulting in higher
      triglyceride and free fatty acid blood levels, occurring in diabetes predisposes these
      individuals to increased thrombotic events. Unless the underlying mechanisms responsible for
      these events can be identified, there will be an unprecedented number of diabetic patients
      suffering thrombotic episodes in the next 10 years.

      The specific aims of this study are to determine the effects of elevated free fatty acids and
      hyperglycemia (high glucose)on endothelial function and thrombolytic balance in patients with
      type 2 diabetes, and to determine the effects of increased insulin in this setting.
    

Intervention name(s): euinsulinemic euglycemic glucose clamp; euinsulinemic hyperglycemic glucose clamp; Hyperinsulinemic euglycemic glucose clamp; Hyperinsulinemic hyperglycemic glucose clamp
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): euinsulinemic euglycemic glucose clamp with lipid infusion 48 ml/hr for 4 hours; euinsulinemic hyperglycemic glucose clamp with lipid infusion at 48 ml/hr for 4 hours; Hyperinsulinemic euglycemic glucose clamp with lipid infusion at 48 ml/hr for 4 hours; Hyperinsulinemic hyperglycemic glucose clamp with lipid infusion at 48 ml/hr for 4 hours
Other intervention name(s): Intralipid; Intralipid; Intralipid; Intralipid
Intervention MeSH terms: Soybean oil, phospholipid emulsion
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: endothelial function; fibrinolytic balance
A Post-Market Surveillance Study of Using the g-Cath EZ for Treating Obesity
Condition: Treatment of Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      This is a multi-center, prospective study evaluating a treatment for obesity.
    

Detailed description: 
      This is a multi-center, prospective study evaluating a treatment for obesity using the g-Cath
      EZ and associated devices. The intent is to evaluate the safety and efficacy of a modified
      Snowshoe suture anchor placement pattern called Pose 2 (suture anchors placed in the mid +
      distal body of the stomach, with none placed in the fundus) along with a moderate intensity
      diet and exercise program. The g-Cath EZ and the associated devices (the g-Prox EZ, g-Lix &
      Transport) are known collectively as the Incisionless Operating Platform (IOP). Efficacy of
      the treatment will be evaluated based on changes in weight loss over 12 months, & adverse
      events will be recorded throughout the duration of the study.
    

Intervention name(s): Obesity treatment with a Plication device
Intervention type(s): Device
Intervention description(s): Plicating the stomach to treat obesity
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Current patients of Roman Turro, MD at Centro Medico Teknon in Barcelona, Spain and
        Gontrand Lopez-Nava, MD at Madrid Sanchinarro University Hospital in Madrid, Spain
52 Week Trial of Liraglutide in Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      To our knowledge, no trial has specifically studied the effect of liraglutide combined with a
      basal/bolus insulin regimen in type 1 diabetes in a cross-over, double-blind, unicentric
      model. Moreover, the potential impact of a glucagon-like peptide-1 agonist on measures of
      abdominal fat (assessed by CT scan), insulin sensitivity (assessed by the gold standard
      euglycemic-hyperinsulinemic clamp) and satiety sensations have not been evaluated in this
      population.

      Hypothesis Overweight participants with type 1 diabetes on liraglutide/insulin treatment will
      present improved glucose control with decreased HbA1c, decreased fasting and mean weekly
      glucose concentrations and glycemic excursions as well as increased insulin sensitivity
      compared to participants on placebo/insulin treatment. Participants with liraglutide/insulin
      treatment will also present improved endothelial function, lower body weight, central adipose
      tissue assessed by CT scan and higher satiety sensations assessed by visual analogue scales.
    

Detailed description: 
      Participants will be submitted to this double-blind cross-over protocol of 52-week use of
      liraglutide/placebo.
    

Intervention name(s): Liraglutide; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Liraglutide will be compared to placebo for 24 weeks in a cross-over design; placebo will be compared to liraglutide for 24 weeks in a cross-over design
Other intervention name(s): Victoza
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: type 1 diabetes; overweight; insulin; liraglutide
Study Evaluating rhBMP-2/CPM in Closed Distal Radius Fractures
Condition: Radius Fractures
MeSH terms: Fractures, Bone; Radius Fractures; Wrist Fractures
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety of rhBMP-2/CPM administered to subjects presenting with closed distal
      radius fractures. The key safety variables comprising this assessment are: 1) incidence of
      delayed union; 2) median time to fracture union (assessed by the investigators); 3) incidence
      of local neurovascular events (those involving the region under study [RUS]); and 4) rate of
      fracture displacement. The primary objective will be met if these outcomes in the active and
      placebo treatment groups are at least comparable to those of the SOC control group.
    


Intervention name(s): rhBMP-2/CPM
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Distal Radius Fractures
A Study of Progenta (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata
Condition: Uterine Leiomyomata
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A study of 3 doses of Progenta versus placebo versus Lucron Depot for treatment of
      leiomyomata.
    

Detailed description: 
      Three doses of Progenta (CDB4124 - 12.5, 25, 50 mg) versus placebo versus Lucron Depot
      (leuprolide acetate for depot suspension) was initiated in females with symptomatic
      leiomyomata. A single dose PK visit was conducted only for subjects randomized to the
      Progenta arm, between screening and visit 1. A second PK assessment was conducted at Visit 3
      (one month on drug) to collect steady state data. Treatment period lasted for 3 months.
    

Intervention name(s): Progenta; Progenta; Progenta; Lucron Depot; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 12.5 mg, administered as a once daily oral dose for 90 days.; 25 mg, administered as a once daily oral dose for 90 days.; 50 mg, administered as a once daily oral dose for 90 days.; 3.75 mg IM monthly; Administered as a once daily oral dose for 90 days.
Other intervention name(s): CDB-4124; Telapristone acetate; CDB-4124; Telapristone acetate; CDB-4124; leuprolide acetate for depot suspension
Intervention MeSH terms: Leuprolide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Uterine fibroids
A Study of LY2835219 in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Participants in this study will receive 3 single oral doses of LY2835219 at least 14 days
      apart. One dose will be given with a standard meal, one dose with a high-fat meal and one
      dose without food. The study will evaluate the effects of the standard and high-fat meals on
      how much drug gets into the bloodstream. Side effects will be documented. This study is
      approximately 43 days, not including screening. Screening is required within 28 days prior to
      the start of the study.
    


Intervention name(s): LY2835219
Intervention type(s): Drug
Intervention description(s): Administered orally.
Other intervention name(s): abemaciclib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Erector Spinae Versus Ilioinguinal/ Ilio-hypogastric Block in Children Undergoing Inguinal Surgeries
Condition: Inguinal Hernia
MeSH terms: Hernia, Inguinal
Study type: Interventional

Summary: 
      Investigators aim to compare the efﬁcacy of US-guided II/IH nerve block versus US-guided ES
      block for pediatric unilateral inguinal hernia repair with respect to postoperative analgesia
    

Detailed description: 
      regarding patient registry; a prior G power analysis was done. 24 per group was determined to
      achieve 80% power to detect a difference of 60 min in time to first rescue analgesia between
      the two groups with a significance level (α) of 0.05 using a two-sided two-sample t-test; 25
      patients were included per group to replace any dropouts.

      - Statistical analysis: Data will be analyzed through SPSS (Statistical Package for Social
      Sciences). Program version 22. Distribution of data will be first tested by the Shapiro test.
      Data will be presented as the mean and standard deviation (SD), median and range or numbers
      and percentages. For normally distributed data, the unpaired t-test will be used to compare
      the mean values of both groups. For pain score, Mann Whitney U test will be used. Fisher's
      exact test will be used for comparison of categorical data. The P value ≤ 0.05 will be
      considered as the level of statistical significance.
    

Intervention name(s): Ilioinguinal/iliohypogastric nerve blocks; Erector spinae nerve block
Intervention type(s): Procedure; Procedure
Intervention description(s): The patient will receive ultrasound-guided Ilioinguinal/iliohypogastric nerve blocks with0.5 ml/kg 0.125 mg/kg bupivacaine + fentanyl 2ug/ml injectate; The patient will receive ultrasound-guided erector spinae nerve block 0.5 ml/kg 0.125 bupivacaine + fentanyl 2ug/ml injectate.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Efficacy and Safety of a Neoadjuvant Treatment in Pancreatic Cancer
Condition: Pancreatic Adenocarcinoma
MeSH terms: Adenocarcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II open study, not randomized with a neoadjuvant therapy,combination of
      Gemcitabine (1,000 mg/m2/week) with Erlotinib (100mg/day) (3 cycles of 4 weeks), followed by
      gemcitabine (300 mg/m2/week) combined with Erlotinib (100mg/day) and radiotherapy (45 Gy /
      day fr180 cGy) (5 cycles of 1 week) in patients with resectable pancreatic adenocarcinoma to
      assess the percentage of R0 resections. They have planned a total of 21 visits.
    


Intervention name(s): Gemcitabine and Erlotinib
Intervention type(s): Drug
Intervention description(s): Administration of gemcitabine (300mg/m2/weekly)with Erlotinib (100 mg/daily) and radiotherapy (45 Gy/daily) after a period of infusion with a full dose of Gemcitabine (1.000mg/m2/weekly) and Erlotinib (100 mg/daily)
Other intervention name(s): Gemcitabine and Tarceva
Intervention MeSH terms: Gemcitabine; Erlotinib Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Resectable pancreatic adenocarcinoma; Gemcitabine; Erlotinib; Radiotherapy; Neoadjuvant treatment
A Study To Investigate Safety, Blood Levels And Effects Of Giving GW642444, By Mouth, By Inhalation & By Injection
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will involve the use of a new medicine called GW642444 being developed for the
      treatment of asthma and chronic obstructive pulmonary disease (COPD). The purpose of the
      study is to see how safe and how well tolerated the study drug is when it is given as a
      liquid by mouth or by injection into a vein. In addition the study will measure how much of
      the medicine gets into the bloodstream when it is given by mouth, by injection into a vein
      and inhaled, and how long the body takes to get rid of it.
    

Detailed description: 
      This will be a single-centre, open-label, dose-ascending study in 9 healthy male subjects to
      establish safe and well tolerated systemic exposure safety margins for GW642444 following
      intravenous and oral dosing to support future studies. Additionally a single inhaled dose of
      GW642444M will be administered to provide data to estimate inhaled bioavailability of
      GW642444 and the extent of renal excretion following dosing via this route. It is planned to
      administer four, dose-ascending, intravenous administrations of GW642444 during treatment
      periods 1, 2, 3 and 5; the inhaled dose would be administered in treatment period 4 and the
      oral dose in treatment period 6. The sequence of treatment administration may be altered if
      required for logistical reasons, however doses of intravenous and oral GW642444 will be
      administered strictly in dose ascending order. All intravenous doses will be administered as
      an infusion given at a constant rate over a 1 hour period.
    

Intervention name(s): GW642444; GW642444; GW642444; GW642444; GW642444; GW642444
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 2.5mcg IV; 5mcg IV; 10mcg IV; 100mcg inhaled; 20mcg IV; 500mcg oral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intravenous,; tolerability; pharmacokinetics,; oral,; pharmacodynamics,; safety,; GW642444,; inhaled,
Add-on Study for Protocol G200802 (NCT02463032): Effect of GTx-024 on Maximal Neuromuscular Function and Lean Body Mass
Condition: ER+ and AR+ Breast Cancer
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multiple site, proof of concept feasibility study to describe the effect of GTx-024
      9 or 18 mg on physical function in female subjects, from protocol G200802, with ER+/AR+
      breast cancer.
    


Intervention name(s): GTx-024 9 or 18 mg
Intervention type(s): Drug
Intervention description(s): Patients enrolled in G200802 receiving GTx-024 9 or 18 mg
Other intervention name(s): Enobosarm
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis
Condition: Chronic Sinusitis
MeSH terms: Sinusitis
Study type: Interventional

Summary: 
      A non-randomized, multi-center, prospective, clinical study intended to evaluate the safety
      and efficacy of balloon sinuplasty devices in pediatric patients with longstanding sinusitis
      following failed medical management.
    


Intervention name(s): Relieva™ Balloon Sinuplasty™ System
Intervention type(s): Device
Intervention description(s): Balloon dilation will be performed using endoscopic equipment with video documentation capability.
Other intervention name(s): Relieva
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment