bioihbjkbjnl/mcl2 huggingface dataset:
Carbamazepine for the Treatment of Chronic Post-Traumatic Brain Injury Irritability and Aggression
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries; Aggression
Study type: Interventional

Summary: 
      The purpose of this study is to determine if carbamazepine reduces irritability and
      aggression among individuals with traumatic brain injury
    

Detailed description: 
      To achieve the enrollment of 66 needed, over enrollment of 70 subjects with 70 corresponding
      subject informants will be recruited at Carolinas Rehabilitation. Subjects will be recruited
      from the clinic at Carolinas Rehabilitation. Subjects will also be referred by psychiatrists
      at North Carolina Neuropsychiatry.

      Subjects who consent and qualify will be randomized in a 1:1 ratio to Tegretol® or placebo.
      Stratification to randomization group will occur based on the presence of depression defined
      by a Beck Depression Inventory-II score ≥ 13. Subjects randomized to active drug will be
      titrated up in dose, as tolerated, over a period of 3 weeks. Starting dose is 200mg twice
      daily to 200mg three times daily to 200mg, 2 tabs, twice daily. There will be 3 clinic
      visits. Visits will occur at baseline for consenting and screening, day 28, and day 42.
      Follow up phone calls will occur each week that the subject is not seen in the clinic until
      the end of the study. Follow up phone calls will assess for study medication compliance,
      adverse events and concomitant medication changes. Day 42 ends the period of the Randomized
      Clinical Trial phase of the study and the subjects will begin the 1 week of taper of
      Tegretol® at 400mg daily and then stop drug. A safety phone call will be made at day 49.

      The following questionnaires will be used as measures of irritability for the subject and the
      informant: Neuropsychiatric Inventory (NPI), and Global Impression of Change. The Beck
      Depression Inventory will be administered to the participant only at baseline for purposes of
      stratification of the randomization on depression. The Clinician Investigator will complete
      the Clinician Global Impressions scale at Visits 2 and 3.

      History and Physical Exam, hematology, chemistry, including renal and liver function studies
      will be obtained for safety and tolerability. Serum pregnancy tests will be drawn at
      screening for females of childbearing potential. Carbamazepine levels will be drawn at visits
      2 and 3.
    

Intervention name(s): Carbamazepine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 800 mg daily; Placebo
Other intervention name(s): Tegretol
Intervention MeSH terms: Carbamazepine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Brain Injury; Irritability; Aggression
A Relative Bioavailability Study of HRS9531 in Healthy Subjects
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the relative bioavailability of the new formulation
      of HRS9531 injection between the original formulation of HRS9531 injection.
    


Intervention name(s): HRS9531; HRS9531
Intervention type(s): Drug; Drug
Intervention description(s): Receive a single dose of HRS9531 of original formulation.; Receive a single dose of HRS9531 of new formulation.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is a single-dose, parallel design trial, consisting of two parallel groups: a reference formulation group (R: original formulation) and a test formulation group (T: new formulation). Both R and T groups receive a same dose of HRS9531.
Masking: None (Open Label)
Primary purpose: Treatment
Phase II Study of BNC210 in PTSD
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled study, evaluating the effects of
      BNC210 versus placebo on the symptoms of Post-Traumatic Stress Disorder, as measured by the
      Clinician-Administered PTSD Scale for DSM-5 (CAPS-5).

      The secondary objectives of the study are to evaluate the effects of BNC210 on anxiety,
      depression, global functioning and patient reported outcomes in patients with PTSD. Safety
      and tolerability of BNC210 will also be assessed. Study participants will receive 12 weeks of
      blinded treatment followed by a 3 week follow-up period.
    


Intervention name(s): BNC210; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Tracking IUD Bleeding Experiences: An Evaluation of Bleeding Profiles in New Intrauterine Device Users
Condition: Intrauterine Devices, Copper; Metrorrhagia; Menstruation; Menstrual Cycle
MeSH terms: Metrorrhagia; Hemorrhage
Study type: Interventional

Summary: 
      This study aims to use validated tools as well as new technology to examine changes in
      bleeding patterns among women who are initiating the copper T380A IUD.
    

Detailed description: 
      New users of the intrauterine device (IUD) are most likely to discontinue use within the
      first six months after insertion. The most common reason for discontinuation of the copper
      IUD is symptoms related to bleeding. Research looking at disturbances in bleeding patterns
      among new IUD users is sparse and dated. Perceived changes in vaginal bleeding may impact
      method satisfaction, acceptability, and continuation. There is a need for updated research
      evaluating changes in bleeding patterns in order for providers to better counsel patients on
      what to expect during the months after initiation of an IUD.

      A variety of methods to evaluate bleeding profiles are available. The World Health
      Organization (WHO) published recommendations for methods of collection and analysis of
      bleeding patterns. The WHO method includes data collection on bleeding days (days when blood
      loss requires the use of a menstrual pad or tampon) and spotting days (when no protection was
      needed) using 90-day referent periods. A second tool, the pictorial blood loss assessment
      chart (PBAC) has been shown to be an inexpensive and objective method of assessing blood
      loss. The PBAC takes into consideration how heavy blood flow is as well as the number of
      sanitary napkins and tampons used. Additionally, new technologies (including mobile period
      tracking applications) have made retrospective collection of bleeding data more feasible and
      prospective data collection more accurate.

      This study aims to incorporate these validated tools as well as new technology to examine
      changes in bleeding patterns among women who are initiating the copper T380A IUD.
    

Intervention name(s): T380A Intrauterine Copper Contraceptive
Intervention type(s): Device
Intervention description(s): The T380A is intrauterine device (IUD) that used to prevent pregnancy. It is a soft, flexible T-shaped device made primarily of plastic and copper that is inserted into the uterus.
Other intervention name(s): Paragard
Intervention MeSH terms: Copper; Contraceptive Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Non-Comparative Study To Evaluate Changes In FMD After Quinapril Therapy In Hypertensive Women
Condition: Menopause; Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      ACE inhibitors are thought to modify the endothelium in a number of ways. Quinapril is an
      effective and well-tolerated ACE-I for the treatment of patients with hypertension and
      congestive heart failure. Quinapril produces favourable haemodynamic changes and improves
      ventricular and endothelial function in patients with various cardiovascular disorders. These
      effects are mediated through the binding of quinaprilat to both tissue and plasma-ACE.

      Quinapril 10 to 40 mg once daily improved endothelial function (as measured by improved FMD
      or reduced vasoconstrictive/increased vasodilative response to Ach) in patients with CAD and
      hypertension over 2 to 6 months of therapy; improved endothelial function was also observed
      in patients with CHF receiving a single infusion of quinaprilat. In general, quinapril showed
      neutral or beneficial effects on lipid profiles, glycaemia and renal haemodynamics. (3) There
      are no data available considering effects of quinapril on endothelial dysfunction in post-
      menopausal woman with mild to moderate hypertension and with pathological endothelial
      function.
    


Intervention name(s): quinapril; Laser Doppler imaging
Intervention type(s): Drug; Procedure
Intervention MeSH terms: Quinapril
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety Study of GNbAC1 Monoclonal Antibody in Healthy Male Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      In this clinical study, the safety and tolerability of GNbAC1 as a treatment for MS patients
      will be evaluated in healthy male volunteers.
    

Detailed description: 
      The monoclonal antibody, GNbAC1, targets the envelope protein (Env) of the human endogenous
      retrovirus (HERV), also called multiple sclerosis associated retrovirus (MSRV), which is
      considered as a critical factor in the development of multiple sclerosis.

      This study will assess the pharmacokinetics, safety and tolerability of GNbAC1 following
      single ascending doses (6, 18, and 36 mg/kg) administered via IV infusion.
    

Intervention name(s): GNbAC1
Intervention type(s): Drug
Intervention description(s): Single dose of IMP, IV infusion
Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: GNbAC1; Multiple Sclerosis; Multiple Sclerosis Associated Retrovirus (MSRV); MSRV-Envelope protein; Monoclonal antibody; Temelimab
Study to Investigate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of Single & Repeat Doses of GSK2269557
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will comprise three Parts:

      Part A will consist of two cohorts of healthy male volunteers to assess the safety,
      tolerability and pharmacokinetics of ascending single doses of nebulised GSK2269557. Blinded
      safety and available PK data will be reviewed before each dose escalation.

      Part B will be one cohort to examine the safety, tolerability and pharmacokinetics of a
      repeated dose of GSK2269557 given by nebuliser for 7 days in healthy male volunteers. The
      total daily dose will be the same as, or lower than, doses that are well tolerated in Part A.

      Part C will consist of two cohorts of single nebulised doses in healthy male smokers, to
      assess pharmacodynamic endpoints in sputum and bronchoalveolar lavage.
    


Intervention name(s): GSK2269557; GSK2269557 matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): Study Drug; Study Drug
Intervention MeSH terms: Nemiralisib
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Single-Center, Open-Label, Randomized, 3-Treatment Crossover Bioavailability Study of Single Oral Doses of E5501 Old Tablet Formulation Under Fasted Conditions and a New Tablet Formulation Under Fed and Fasted Conditions in Healthy Subjects
Condition: Healthy Subjects
MeSH terms: Malnutrition; Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be a single-center, open-label, randomized, 3-treatment crossover
      bioavailability study of single oral doses of E5501 old tablet formulation under fasted
      conditions and a new tablet formulation administered under fed and fasted conditions in
      healthy subjects.
    


Intervention name(s): E5501; E5501; E5501
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Treatment A: 40 mg new tablet formulation (1 tablet) under fasted conditions; Treatment B: 20 mg old tablet formulation (2 tablets) under fasted conditions; Treatment C: 40 mg new tablet formulation administered with food
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Trial Investigating the Accuracy and Precision of the BGStar® and iBGStar® Blood Glucose Meter in Subjects With Type 1 Diabetes
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      Due to continuing technological progress and better understanding of the needs for glucose
      monitoring, the performance requirements of blood glucose meters, primarily regarding their
      accuracy, are constantly debated and keep evolving as a consequence. Recently a discussion
      was initiated by the Food and Drug Administration (FDA) to improve the accuracy of BG meters
      in the point-of-care testing setting by asking for fulfilment of higher requirements.
    


Intervention name(s): Comparison of different Blood Glucose Meters
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Effect of Cytochrome P 450 3A4 Inhibition by Itraconazole on the Single Oral Dose Pharmacokinetics of Cilobradine
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the effect of cytochrome P 450 3A4 inhibition by itraconazole on the
      single dose pharmacokinetics of cilobradine
    


Intervention name(s): Cilobradine, low dose; Cilobradine, high dose; Itraconazole
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Sempera®
Intervention MeSH terms: Itraconazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Role of Anti Mullerian Hormone for Ovarian Reserve Determination of Preoperative and Postoperative Endometrioma Patients
Condition: Endometrioma; Surgery
MeSH terms: Endometriosis
Study type: Observational [Patient Registry]

Summary: 
      Ovarian reserve influenced by many factor but especially cysts like endometrioma. Anti
      mullerian hormone is recent marker for ovarian reserve. The investigators are searching
      ovarian reserve pre and post operatively by using antimullerian hormone of endometrioma
      patient who are operated for their cysts.
    

Detailed description: 
      long term results of the postoperative follow up for the endometrioma patients
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Females who are administring gynecology clinic suffering from symptomatic benign ovarian
        cysts.
      
Biospecimen description: 
      We are collecting serum samples of pre and post operative endometroma patients and measuring
      anti müllerian hormone levels.
    
Keywords: Ovarian reserve; Antimullerian hormone
Comparing the Efficacy of Bricanyl M2 and Bricanyl M3 at 0.5 and 1.5 mg Dose Levels, to Allow for a Switch From Bricanyl Turbuhaler M2 to Bricanyl Turbuhaler M3
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomised, double-blind, double-dummy, multi-site, phase III, single dose, 4-way
      cross-over pharmacodynamic study evaluating the efficacy of Bricanyl Turbuhaler M3 compared
      to Bricanyl Turbuhaler M2 by studying the protective effect on methacholine induced
      bronchoconstriction in patients with stable, mild to moderate asthma
    

Detailed description: 
      The study will include female and male patients, between 18 and 65 years old, with stable,
      mild to moderate asthma who are on short acting β2-agonist (SABA) alone, on low dose inhaled
      corticosteroid (ICS) (200-400 µg budesonide or corresponding) or on a combination of low dose
      ICS and long acting β2-agonists (LABA). Approximately 60 patients will be randomised in order
      to have 49 completed.

      The primary objective is to demonstrate therapeutic equivalence between Bricanyl Turbuhaler
      M3 and Bricanyl Turbuhaler M2 using bronchoprotective effect. Outcome measure: PC20
      (Methacholine provocative concentration causing a 20% drop in FEV1). The safety objective is
      to compare safety of Bricanyl Turbuhaler M2 and Bricanyl Turbuhaler M3. Outcome measure
      Adverse Events/Serious.

      Study period Q1 2015 - Q1 2016.
    

Intervention name(s): Terbutaline sulphate; Terbutaline sulphate; Placebo for terbutaline sulphate; Placebo for terbutaline sulphate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Bricanyl Turbuhaler M2; Bricanyl Turbuhaler M3; Placebo Turbuhaler M2; Placebo Turbuhaler M3
Other intervention name(s): Terbutaline sulphate powder for inhalation, 0.5 mg (metered dose) terbutaline per inhalation; Terbutaline sulphate powder for inhalation, 0.4 mg (delivered dose) terbutaline per inhalation; Placebo powder for inhalation; Placebo powder for inhalation
Intervention MeSH terms: Terbutaline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Inhalation, Pharmacodynamic, Patients,
Polyphenols in Sorghum and Iron Absorption
Condition: Iron Absorption in Presence of Polyphenols
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Iron deficiency and iron deficiency anemia are two major public health problems in developing
      countries. In these countries, the use of monotonous plant-based diets, low in animal source
      food but high in iron absorption inhibitors such as phytic acid or polyphenol, lead to poor
      iron status or aggravate poor iron status caused by infections. In many West African
      countries sorghum is a major source of energy, protein, vitamins and minerals especially for
      the most poverty-stricken people. Some sorghum varieties are known to contain high levels of
      polyphenols which have an inhibitory effect on iron absorption in humans. Polyphenols are a
      huge group of plant metabolites with varying chemical structures. Depending on their
      structure, the level of complex formation with iron in the intestine and thus the negative
      effect on iron absorption is different.

      Micronutrient deficiency can be combated by fortification of plant-based staples.
      Fortification is a promising food-based approach which can be applied when other strategies
      fail to provide adequate levels of the respective micronutrient in the diet. To fortify foods
      with iron, a wide variety of different iron compounds have been used. The iron compound
      sodium iron ethylenediaminetetraacetic (NaFeEDTA) overcomes the inhibitory effect of phytate
      on human iron absorption. No information about the potential enhancing effect of NaFeEDTA in
      presence of polyphenol is available.

      The aims of the study are to investigate the effect of different sorghum polyphenol
      concentrations on human iron absorption and to investigate if the negative impact of the
      polyphenols can be overcome by using NaFeEDTA as iron compound. The study will include 32
      apparently healthy young women which will consume sorghum porridges with different polyphenol
      levels and sorghum porridges fortified with ferrous sulfate as compared to NaFeEDTA.
      Furthermore test meals with added vitamin C or added laccase will be compared to a control
      meal. Iron absorption will be determined by stable isotope technique.
    


Intervention name(s): labeled iron solutions
Intervention type(s): Dietary Supplement
Intervention description(s): labeled iron as 2 mg 58FeSO4, 57FeSO4 or 54FeSO4 per test portion (50g sorghum) 2 mg labeled iron as NaFeEDTA per test portion (50g sorghum)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: iron absorption; polyphenols; sodium iron EDTA; sorghum
A Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study of TLL018, With Food Effect, in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      TLL018 is developed for treatment of autoimmune and inflammatory diseases including
      rheumatoid arthritis. The purposes of this study are (1) determining if and at what doses
      TLL018 is safe and can be tolerated when administered to humans, (2) assessing what TLL018
      does to the body and how the body responds to TLL018 when given as single and multiple doses,
      and (3) assessing potential food effect on TLL018.
    


Intervention name(s): TLL018 tablet, placebo
Intervention type(s): Drug
Intervention description(s): Oral QD
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Investigation of Clinical Spectrum, Bacterial Pathogens and Immune Response in Acute Pharyngotonsillitis
Condition: Tonsillitis
MeSH terms: Tonsillitis
Study type: Observational

Summary: 
      Acute pharyngotonsillitis is one of the most common infections encountered by pediatricians.
      Most children with acute pharyngotonsillitis have symptoms that can be attributed to viral
      infection. However 30-40% of cases is of bacterial etiology.

      The purpose of this study is to examine frequency, age distribution, clinical picture and
      pathogen distribution in acute pharyngotonsillitis in children in a large urban setting.
    

Detailed description: 
      According to the US Vital Health Statistics report, acute pharyngotonsillitis is responsible
      for more than 6 million office visits each year by children younger than 15 years of age.
      Approximately 30% of cases is of bacterial etiology and group A beta-hemolytic
      streptococci(GABHS) are responsible for most bacterial cases, although other pathogens, such
      as Neisseria gonorrhoeae, Arcanobacterium haemolyticum, Mycoplasma pneumoniae, and Chlamydia
      pneumoniae, may be the causative agents in sporadic cases. An accurate diagnosis of GABHS
      infection is important because it is the only common form of acute pharyngotonsillitis for
      which antibiotic therapy is definitely indicated. Effective antibacterial treatment can
      shorten the clinical course of GABHS pharyngotonsillitis, reduce the rate of transmission,
      and prevent suppurative and nonsuppurative complications, such as peritonsillar abscess and
      acute rheumatic fever.

      This study enrolls patients who will present with acute fever and clinical signs of
      pharyngotonsillitis at three primary pediatric ambulances. A rapid A beta-hemolytic
      streptococcus (GABHS)-detection test will be performed in these patients. In one office,
      additional throat cultures are obtained of all patients, and blood is taken in a subgroup of
      60 GABHS-positive and 60 GABHS-negative cases. In GABHS-positive patients, a second blood
      sample will be obtained at day 7th and day 28th, and stored until specific antibody response
      to GABHS will be measured.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients aged 3 months to 18 years who will present clinical signs of tonsillopharyngitis.
      
Biospecimen description: 
      throat culture, blood sample
    
Keywords: Upper airway infections; pharyngotonsillitis; GABHS