bioihbjkbjnl/mcl2 huggingface dataset:
TOPIC Trial for COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The study is a randomized, double-blind, placebo-controlled, multiple-dose, pilot study of
      orally-administered ivacaftor in subjects with chronic obstructive pulmonary disease.
      Subjects will be administered the study drug ivacaftor 150 mg (or placebo) twice daily (BID).
    


Intervention name(s): Ivacaftor; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Kalydeco
Intervention MeSH terms: Ivacaftor
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Obstructive pulmonary disease, Ivacaftor
Phase II Study of Sodium Phenylbutyrate, Sodium Benzoate, Sodium Phenylacetate, and Dietary Intervention for Urea Cycle Disorders
Condition: Amino Acid Metabolism, Inborn Errors
MeSH terms: Metabolism, Inborn Errors; Amino Acid Metabolism, Inborn Errors
Study type: Interventional
Phase: Phase 2

Summary: 
      OBJECTIVES:

      I. Assess the safety and efficacy of sodium phenylbutyrate, sodium benzoate, sodium
      phenylacetate, and dietary intervention in patients with urea cycle disorders.
    

Detailed description: 
      PROTOCOL OUTLINE: This protocol describes several clinical studies of pharmacologic and
      dietary management in patients with urea cycle disorders.

      Patients with carbamyl phosphate synthetase and ornithine transcarbamylase deficiency are
      treated with a low-protein diet, essential amino acids (for neonatal onset disease), caloric
      supplementation, oral sodium phenylbutyrate (now approved as a prescription drug 11/97), and
      citrulline or arginine free base.

      Patients with argininosuccinic acid synthetase deficiency are treated with a low-protein
      diet, caloric supplementation, oral sodium phenylbutyrate (now approved as a prescription
      drug 11/97), and arginine free base.

      Patients with argininosuccinic aciduria (AA) are treated with a low-protein diet, caloric
      supplementation, and arginine free base. (Discontinued 11/97) Any patient who develops
      hyperammonemia is treated with intravenous sodium benzoate, sodium phenylbutyrate, and
      arginine hydrochloride; benzoate and phenylbutyrate are not given to patients with AA.

      If ammonium stabilizes at normal or near normal levels, intravenous medications are gradually
      replaced by oral medications. If there is no significant decrease in ammonium within 8 hours,
      patients begin hemodialysis.

      Concurrent therapy with ondansetron, high caloric intake, and mannitol for elevated
      intracranial pressure is allowed. Dietary and intravenous nitrogen is prohibited.
      (Discontinued 11/97)
    

Intervention name(s): Sodium Benzoate; Sodium Phenylacetate; Sodium Phenylbutyrate; Dietary Intervention
Intervention type(s): Drug; Drug; Drug; Behavioral
Intervention MeSH terms: Sodium Benzoate; 4-phenylbutyric acid; Phenylacetic acid
Primary purpose: Treatment
Keywords: inborn errors of metabolism; rare disease; urea cycle disorder
Safety Study of Rituximab (SC) Administered in Participants With CD20+ DLBCL or CD20+ Follicular NHL Grade 1 to 3A
Condition: Non-Hodgkin Lymphoma
MeSH terms: Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 3

Summary: 
      This open-label, single-arm study will evaluate the safety of rituximab subcutaneously (SC)
      administered during first line treatment for follicular non-Hodgkin's lymphoma (NHL)
      (Induction and/or Maintenance treatment plus 24 months of follow up), or diffuse large B-cell
      lymphoma (DLBCL) (treatment plus 24 months of follow-up).
    


Intervention name(s): Rituximab; Cyclophosphamide; Doxorubicin; Vincristine; Prednisone; Fludarabine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Rituximab SC 1400 mg; Cyclophosphamide will be administered as per standard local practice.; Doxorubicin will be administered as per standard local practice.; Vincristine will be administered as per standard local practice.; Prednisone will be administered as per standard local practice.; Fludarabine will be administered as per standard local practice.
Other intervention name(s): MabThera®; Endoxan
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Fludarabine; Vincristine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Cefprozil Tablets, USP 500 mg Undef Fed Conditions
Condition: Healthy
MeSH terms: Disease
Study type: Interventional

Summary: 
      The objective of this study is to assess the single - dose relative bioavailability of
      Ranbaxy and Bristol-Myers Squibb Company (CEFZIL ®) 500 mg cefprozil tablets, under fed
      conditions.
    

Detailed description: 
      A single dose, randomized, two-period, two-treatment, two-sequence crossover study design was
      used to evaluate the relative bioavailability of the cefprozil tablet products when dosed (1
      x 500 mg) under fed conditions. The washout period will be at least 14 days between doses.

      Twenty four plus two alternate (24 + 2) subjects were enrolled in this study and all
      volunteers were healthy adults. Twenty six (24 + 2) subjects began the study, and twenty-five
      (23 + 2) subjects completed the clinical portion of the study in its entirety.
    

Intervention name(s): cefprozil 500mg tablets
Intervention type(s): Drug
Intervention MeSH terms: Cefprozil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence cefprozil 500mg tablets fed conditions
Total-body PET/CT Imaging Using the uEXPLORER in Non-small Cell Lung Cancer Patients Treated by Induction Chemotherapy Plus Nivolumab and Definitive Concurrent Chemoradiotherapy
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Observational [Patient Registry]

Summary: 
      The prospective study aims to explore the value of total-body PET/CT dynamic imaging
      (uExplorer) in assessing tumor metabolic heterogeneity and predicting prognosis for patients
      with locally advanced, unresectable non-small cell lung cancer (stage III) treated by
      neoadjuvant chemotherapy plus nivolumab and definitive concurrent chemoradiation therapy.
    


Intervention name(s): Total body PET/CT (uExplorer)
Intervention type(s): Device
Intervention description(s): A total-body positron emission tomography/computed tomography (PET/CT) scanner (uEXPLORER) with a 192-cm scan range was applied for cancer diagnosis, organ function assessment and treatment outcome prediction. The total-body PET scanner can acquire scans with lower administered activity or short acquisition time, total-body dynamic acquisition at a longer delayed time point, and high detectability of exiguous changes of the whole body, and tumor as well.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Locally advanced non-small cell lung cancer patients treated by neoadjuvant chemotherapy
        plus nivolumab and definitive concurrent chemoradiation therapy
      
Keywords: Non-small Cell Lung Cancer; Total-body PET/CT; uEXPLORER; Nivolumab
Multicenter, Open, Randomized Comparative Trial To Compare The Efficacy Of Azithromycin Versus Amoxicillin In Children With Strep Throat
Condition: Tonsillitis
MeSH terms: Tonsillitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective was to compare the bacteriological efficacy at Day 10 of azithromycin
      pediatric suspension (20 mg/kg/day once daily for 3 consecutive days) versus amoxicillin
      pediatric suspension (50 mg/kg/day in 2 doses for 6 consecutive days) in children aged 3-15
      years with Group A streptococcal acute pharyngitis/tonsillitis. Secondary objectives were
      assessments of bacteriological efficacy at Day 30 and clinical efficacy at Day 10 and Day 30.
    


Intervention name(s): Zithromax; Clamoxyl
Intervention type(s): Drug; Drug
Intervention description(s): azithromycin (Zithromax) pediatric suspension formulation (200 mg/5 ml) administered as an oral suspension at a dose of 20 mg/kg once a day (maximal dose 500 mg/day) for 3 consecutive days; Amoxicillin (Clamoxyl) pediatric formulation (500 mg/5 ml) administered as an oral suspension at a dose of 25 mg/kg twice daily (maximal dose 2 g/day) for 6 consecutive days
Intervention MeSH terms: Azithromycin; Amoxicillin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fatty Acid Antiarrhythmia Trial (FAAT)
Condition: Arrhythmia; Heart Diseases; Tachycardia, Ventricular; Ventricular Fibrillation
MeSH terms: Heart Diseases; Tachycardia; Ventricular Fibrillation; Tachycardia, Ventricular
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine if the dietary N-3 class of polyunsaturated fatty acids (PUFAs) provided in the
      diet largely from marine fish oils would prevent fatal ventricular tachycardia (VT) or
      ventricular fibrillation (VF).
    

Detailed description: 
      BACKGROUND:

      Sudden death is a common manifestation of ischemic heart disease and therefore of great
      public health concern. Unfortunately several promising antiarrhythmic drugs proved not to be
      effective in preventing sudden deaths. This project would test whether a relatively
      inexpensive and presumably innocuous therapy, fish oil supplements, can prevent
      life-threatening arrhythmias. There is ample basic evidence that n-3 fatty acids contained in
      fish oil supplements may suppress arrhythmias, and a clinical trial seems warranted.

      DESIGN NARRATIVE:

      Prospective, randomized, placebo-controlled, double-blind. Patients were randomized to 4
      grams per day of a PUFA fish oil supplement versus an olive oil placebo. The number of
      therapeutic discharges were recorded from the ICDs and then confirmed from the recorded
      electrocardiogram strips with the kinds of arrhythmias which had induced the ICD response.
      The primary end point, time to first ICD event for ventricular tachycardia or fibrillation
      (VT or VF) confirmed by stored electrograms or death from any cause, was analyzed by
      intention to treat.

      The study completion date listed in this record was obtained from the "End Date" entered in
      the Protocol Registration and Results System (PRS) record.
    

Intervention name(s): dietary polyunsaturated fatty acid
Intervention type(s): Behavioral
Allocation: Randomized
Masking: Double
Primary purpose: Prevention
Hydrocortisone Replacement in Patients With Secondary Adrenal Insufficiency (SUPREME CORT)
Condition: Adrenal Insufficiency
MeSH terms: Adrenal Insufficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to investigate whether a physiologically low hydrocortisone (HC)
      dose is better for cognition as compared to a physiologically high HC dose. In addition,
      quality of life, metabolic profile and somatosensation will be described in relation to HC
      dose.
    

Detailed description: 
      -  Rationale: A wide variety in hydrocortisone (HC) substitution dose-regimens are
           considered physiological for patients with adrenal insufficiency. However, it is likely
           that cognition is negatively influenced by higher cortisol exposure to the brain. No
           studies have been performed to assess the effects of treatment regimens with a low
           physiological HC substitution dose on cognition in comparison to a high physiological HC
           substitution dose. These treatment regimens should take body weight and multiple dosing
           into account. In addition, substitution doses should be monitored by clinical evaluation
           and biochemical analysis for adverse effects associated with over- or under-replacement.

        -  Intervention: Patients with secondary adrenal insufficiency will be randomized in two
           groups to receive either a low dose HC (0.2-0.3 mg/kg body weight) for 10 weeks followed
           by 10 weeks of high dose HC (0.4-0.6 mg/kg body weight) or vice versa. At baseline and
           after both treatment periods, patients will be tested.
    

Intervention name(s): Hydrocortisone
Intervention type(s): Drug
Intervention description(s): Patients receive either a low dose HC (0.2-0.3 mg/kg body weight) for 10 weeks followed by 10 weeks of high dose HC (0.4-0.6 mg/kg body weight) or vice versa.
Intervention MeSH terms: Hydrocortisone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hydrocortisone; Cognition; Adrenal insufficiency; Quality of Life; Common Somatic Complaints; Cardiovascular/Metabolic Profile; Somatosensation
Effects of Social Skills and Physical Activity Training on Recreational Activities in Youth
Condition: Social Skills; Physical Activity
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effect of social skills training on adolescents
      physical activity levels. For one week at the beginning and end of the study teens will wear
      a BioTrainer to measure their activity levels and also wear a pager to communicate the types
      of activities they are doing throughout the day. For 8 weeks participants will be randomized
      into one of two groups, a social skills training group or a physical activity group.

      The investigators predict that both groups will experience an increase in physical activity
      and social involvement (decrease time spent alone).
    


Intervention name(s): Social Skills Training; Physical Activity Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Social skills group will consist of one session (60 minutes) per week for 8 weeks; Physical activity groups consist of one session (60 minutes) per week for 8 weeks
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: social skills; physical activity; peer relationships; childhood obesity; changes in physical activity; changes in social involvement
Effectiveness of NeuroMuscular Taping on Painful Hemiplegic Shoulder
Condition: Hemiplegia
MeSH terms: Hemiplegia
Study type: Interventional

Summary: 
      Painful Shoulder Syndrome is a frequent complication after stroke occurring in between 5% and
      84% of patients, often having a strong impact on their well-being and resulting in delays
      achieving rehabilitative objectives.

      The aim of the study is to demonstrate the effectiveness of Neuromuscular Taping in a
      population of post-stroke hemiplegic patients suffering from painful shoulder syndrome with
      respect to pain, spasticity and range of motion.
    

Detailed description: 
      The study will use two groups according to the methodology of Randomized Controlled Trials.
      Both components of the two groups were treated by four rehabilitation sessions defined as
      "standard". This involves joint health and passive mobility for the glenohumeral and
      scapulothoracic joints for a period of about 45 minutes each.

      The patients of the sample group underwent the application of the NeuroMuscular Taping (NMT)
      before each rehabilitative session. The control group was addressed exclusively to the
      "standard" treatment. The sessions were spaced apart about five days to ensure the optimum
      adhesion of NMT.

      The results were evaluated by administering rating scales for pain (VAS) and spasticity
      (Modified Ashworth Scale). The ROM was evaluated using the manual goniometer. The outcomes
      (Pain, Spasticity, ROM) were assessed at base line, before and after each treatment session
      and at 1 month follow up.
    

Intervention name(s): Standard physical therapy program; NeuroMuscular Taping (NMT)
Intervention type(s): Other; Other
Intervention description(s): Standard physical therapy program in this study involves joint health and passive mobility at the level of the shoulder girdle and upper limb affected by Painful Shoulder Syndrome associated with the modulation of hypertonic muscle groups.; The NeuroMuscular Taping (NMT) consists of the application on the skin of an adhesive tape with a particular structure to elastic waves and with characteristics comparable to those cutaneous. Because of these characterises it allows activation of endogenous analgesic, structural and muscular support, vascular and lymphatic activation.
In this study the NMT is applied with decompressive mode on Pectoralis Major, Deltoids, Supraspinatus.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Stroke; Hemiplegia; Painful shoulder Syndrome; NeuroMuscolar Taping
Effectiveness of WhatsApp (a Messenger Program) Usage in Emergency Department (ED)
Condition: Communication
MeSH terms: Emergencies
Study type: Interventional

Summary: 
      Effective communication between consulting physicians and the emergency physicians is
      critical for patients in the emergency department. The aim of this study was to determinate
      effectiveness of whatsApp usage for communication between physicians.
    

Detailed description: 
      Effective communication between consulting physicians and the emergency physicians is
      critical for patients in the emergency department. Many hospitals still use outdated pager
      systems as the foundation for clinical communication between physicians and other health care
      professionals. But, outdated pager systems contain some problems including long waiting-times
      for the return of a page, high costs, frequent interruptions, and the inability to identify
      the location or identity of the caller. This outdated communication technologies in
      healthcare can place patient safety at risk. Therefore they are no longer seen as an
      effective communication tool given the obvious advantages of Smart phones. WhatsApp
      Messenger, which is a messaging program for smart phones, is the most commonly used for
      communication in at present. As of September 2015, WhatsApp incorporated announced more than
      900 million users. This is making it the most globally popular messaging application.
      WhatsApp Messenger have been started to be used for communication in healthcare. So, this
      study aims to trial the effect of whatsApp usage for communication between physicians.

      Study Design and Setting: A prospective, randomized, double-blind, controlled, single-center,
      clinical trial was conducted in ED of a tertiary care university hospital with an annual
      census of approximately 200,000 visits.
    

Intervention name(s): whatsApp; without whatsApp
Intervention type(s): Other; Other
Intervention description(s): whatsApp application will be used for consultations.; whatsApp application will be not used for consultations.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Referral and consultation; emergency department; WhatsApp
Immunogenicity and Safety Study of a Third Vaccination With FSME-IMMUN 0.5 mL in Subjects Previously Vaccinated According to a Rapid Immunization Schedule (Follow-up to Study 225)
Condition: Encephalitis, Tick-borne
MeSH terms: Encephalitis, Tick-Borne; Encephalitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to investigate the immunogenicity and safety of a third
      vaccination with FSME-IMMUN 0.5 ml given approximately 12 months after the second vaccination
      in Study 225. In Study 225, two vaccinations were given using a rapid immunization schedule
      12 ± 2 days apart.
    


Intervention name(s): Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl
Intervention type(s): Biological
Intervention MeSH terms: Formaldehyde
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: tick-borne encephalitis
Pharmacokinetics, Safety and Tolerability of Single Doses of BIIB033 (Opicinumab) Produced by 2 Manufacturing Processes
Condition: Multiple Sclerosis; Acute Optic Neuritis
MeSH terms: Multiple Sclerosis; Neuritis; Optic Neuritis
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to characterize the pharmacokinetics (PK) of BIIB033-B
      and to compare the PK profile with that of BIIB033-A in healthy volunteers. Secondary
      objectives are: To assess the safety and tolerability of BIIB033-A and BIIB033-B; To assess
      the secondary PK parameters of BIIB033-A and BIIB033-B; To assess the immunogenicity of
      BIIB033-A and BIIB033-B.
    


Intervention name(s): BIIB033 (opicinumab)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Healthy Volunteer; opicinumab
Locobase® REPAIR Used as an Adjunctive to Standard Therapy in Children With Moderate to Severe Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess the efficacy of Locobase REPAIR® when used in children with moderate to severe AD
    


Intervention name(s): Locobase® REPAIR
Intervention type(s): Drug
Intervention description(s): emollient
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atopic Dermatitis