bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Olanzapine in the Long-term Treatment for Bipolar I Disorder, Depressed
Condition: Bipolar I Disorder
MeSH terms: Depression
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the efficacy and safety of olanzapine in the long-term treatment for patients with
      bipolar I disorder, depressed.
    

Detailed description: 
      This is an open-label, multi-center, long-term treatment study conducted only in Japanese
      sites. The subjects are patients who fulfill the diagnostic criteria for bipolar I disorder,
      most recent episode depressed, as defined in the Diagnostic and Statistical Manual of Mental
      Disorders Fourth Edition, Text Revision (DSM-IV-TR) (296.50=unspecified, 296.52=moderate
      severity, 296.53=severe without psychotic features, 296.54=severe with psychotic features),
      who have completed Study HGMP (NCT#00510146) and patients who did not participate in Study
      HGMP who have been recruited to participate in Study HGMS.
    

Intervention name(s): Olanzapine
Intervention type(s): Drug
Intervention description(s): 5-20 mg/day, oral, daily
Other intervention name(s): LY170053
Intervention MeSH terms: Olanzapine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bipolar
Efficacy and Safety of Two Anti-T-lymphocyte Immune Globulin (ATG-F) Induction Regimens in Anew Kidney Transplant Patients
Condition: De Novo Kidney Transplant Patients
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate the efficacy and safety of ATG-F induction regimen using a single dose of
      ATG-F compared with a five-day dose regimen of ATG-F in anew kidney transplant recipients.
    

Detailed description: 
      To investigate the efficacy and safety of ATG-F induction regimen using a single dose of
      ATG-F compared with a five-day dose regimen of ATG-F in de novo kidney transplant recipients.
      The primary analysis of this study is to demonstrate the non-inferiority of the two regimens
      with regard to efficacy, defined as failure rate.

      The secondary objective of the study is the assessment of safety and further efficacy
      parameters in terms of incidence of acute rejections, graft/patient survival, DGF(delayed
      graft function) and renal function
    

Intervention name(s): ATG-F
Intervention type(s): Drug
Intervention description(s): Intravenous (IV)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Kidney Transplant Patients; ATG-F
A Pharmacokinetic Dose Proportionality Study of Canagliflozin in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of dose on the pharmacokinetics of
      canagliflozin in healthy volunteers.
    

Detailed description: 
      This is an open-label study where healthy volunteers will know the name and dose of assigned
      treatment and will be randomly assigned to take a single oral (by mouth) dose of
      canagliflozin sequentially in each of 3 treament periods where the dose in each treatment
      period will be different (referred to as a 3-period crossover study) to evaluate the
      pharmacokinetics (blood levels) of 3 dose levels of canagliflozin. Healthy volunteers will
      take a single oral tablet of canagliflozin 50 mg (Treatment A), 100 mg (Treatment B), and 300
      mg (Treatment C) during the study; a different dose will be taken in each treatment period.
      Study drug will be taken in the a.m. on Day 1 of Treatment Periods 1, 2, and 3, with a 10- to
      14-day washout period between Day 1 of each treatment period. Volunteers will fast (go
      without food) for at least 10 hours before and up to at least 4 hours after taking study
      drug.
    

Intervention name(s): Canagliflozin, 50 mg; Canagliflozin, 300 mg; Canagliflozin, 100 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Type=1, unit=mg, number=50, form=tablet, route=oral use.Tablet is taken once without food during 1 of 3 treatment periods.; Type=1, unit=mg, number=300, form=tablet, route=oral use. Tablet is taken once without food during 1 of 3 treatment periods.; Type=1, unit=mg, number=100, form=tablet, route=oral use. Tablet is taken once without food during 1 of 3 treatment periods.
Intervention MeSH terms: Canagliflozin
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Canagliflozin (JNJ-28431754); Pharmacokinetic; Dose proportionality
Subcutaneous Injection of Erythropoietin on Visual Functions in Patients With Late Onset Optic Neuropathy
Condition: Optic Neuropathy
MeSH terms: Optic Nerve Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study aimed to investigate the therapeutic effect of subcutaneous erythropoietin in the
      management of late stage optic neuropathy.
    

Detailed description: 
      Injury of the optic nerve or optic neuropathy is one of the most common causes of vision
      loss. This study aimed to investigate the therapeutic effect of subcutaneous erythropoietin
      in the management of late stage optic neuropathy.
    

Intervention name(s): erythropoietin
Intervention type(s): Drug
Intervention description(s): Systemic erythropoietin injections (eprax 10000 IU subcutaneous twice daily for three days).
Intervention MeSH terms: Epoetin Alfa
Intervention model: Single Group Assignment
Intervention model description: The study included 20 patients diagnosed as late onset optic neuropathy that are attending Alexandria main university hospital.
All patients underwent initially assessment of visual acuity, color vision, pupil reaction ,funduscopy and electrophysiological tests ( pattern visual evoked potential and pattern electroretinogram in both eyes to use data of the normal fellow eye as patients' internal control). Systemic erythropoietin injections (eprax 10000 IU subcutaneous twice daily for three days). Follow up after one month and three months by recording visual acuity and electro physiological studies.
Masking: None (Open Label)
Primary purpose: Treatment
Nutritional Cognitive Behavioral Therapy Feasibility Study in NAFLD and NASH
Condition: Non-alcoholic Steatohepatitis; Non-Alcoholic Fatty Liver Disease; Non-alcoholic Fatty Liver
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      This single arm interventional cohort study is designed to explore the feasibility of using
      BT-NCBT-00x to improve liver fat, inflammation, and stiffness in patients diagnosed with
      NAFLD or NASH over a 3 month intervention.
    

Detailed description: 
      The treatment, BT-NCBT-00x, consists of a software as a medical device developed by the study
      Sponsor, Better Therapeutics. It delivers treatment to participants with cardiometabolic
      disease, using behavioral therapy that targets individual behaviors related to improving
      dietary quality and physical activity. The study evaluates the use of this behavioral therapy
      and its effect on clinical measures such as percent liver fat as measured by MRI-PDFF, and
      Fibroscan Controlled Attenuation Parameter score, liver stiffness as measured by Fibroscan
      Vibration Controlled Transient Elastography in kPA, body weight and ALT. Participants in this
      feasibility study will have access to the treatment for 3- months.
    

Intervention name(s): BT-NCBT-00X
Intervention type(s): Device
Intervention description(s): the intervention group will consist of 20 patients to receive the BT-NCBT-00X treatment for 90 days. They will receive a baseline MRI-PDFF, Fibroscan and have the tests repeated at 90 days.
Intervention model: Single Group Assignment
Intervention model description: This single arm study of 20 patients is to evaluate the feasibility of using BT-NCBT-00x in the treatment of NAFLD and NASH
Masking: None (Open Label)
Primary purpose: Treatment
A Study of JNJ-64417184, Administered as an Oral Solution, in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the food effect on the single-dose pharmacokinetic
      (PK) of the JNJ-64417184 oral solution, administered as 2 different formulations, in healthy
      adult participants.
    


Intervention name(s): JNJ-64417184
Intervention type(s): Drug
Intervention description(s): Single dose of JNJ-64417184 solution (with or without preservatives) will be administered orally.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Comparative Formulation Study of Vabicaserin
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare two different formulations of vabicaserin.
    


Intervention name(s): vabicaserin
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Proposal For The Development Of A Well Defined Database For Patients With Oral Bisphosphonate-Related Osteonecrosis
Condition: Osteonecrosis
MeSH terms: Osteonecrosis
Study type: Observational

Summary: 
      In cooperation with Merck & Co, Inc. we will identify and form a database of 35 patients who
      have developed osteochemonecrosis of the jaws related to oral bisphosphonate use. We will
      study the triggers, associated medical conditions and medications, location of the lesion(s),
      and patient outcomes.
    

Detailed description: 
      This study is an observational study, and not a comparative trial. The major outcome is
      represented by the fraction of subjects with long term healed lesions.
    

Intervention name(s): Observational
Intervention type(s): Other
Intervention description(s): Group of patients with osteochemonecrosis related to oral bisphosphonate use
Other intervention name(s): Osteochemonecrosis
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        patients who develop exposed bone in their mouth and are on an oral bisphosphonate
      
Biospecimen description: 
      biopsy tissue submitted from bone biopsies
    
Keywords: osteonecrosis, jaws, bisphosphonate, fosamax, alendronate
Trial of Mistletoe Extract in Patients With Advanced Solid Tumors
Condition: Solid Tumor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will seek to determine the safety and toxicity profile as well as the maximum
      tolerated dose of Helixor® M in patients with advanced solid tumors.
    

Detailed description: 
      This study is a Phase I study that consists of two phases: a dose escalation phase and an
      expansion phase. The dose escalation phase will be used to evaluate the safety and toxicity
      of Helixor® M (mistletoe extract). An accelerated titration design (ATD) will be utilized to
      determine the MTD. The expansion phase will be used to obtain preliminary efficacy data about
      Helixor® M.
    

Intervention name(s): Helixor® M
Intervention type(s): Drug
Intervention description(s): 3-hour IV infusion on Monday, Wednesday, and Friday of each week.
Other intervention name(s): Mistletoe extract
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Randomized Multicentre Study Comparing TEP With Lichtenstein Repair for Primary Inguinal Hernia
Condition: Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      The purpose of this study was to compare the recurrence rate after TEP (laparoscopic method)
      and Lichtenstein (open method) repair on primary inguinal hernia.
    


Intervention name(s): Open repair; Laparoscopic repair
Intervention type(s): Procedure; Procedure
Intervention description(s): Open repair is according to the Lichtenstein technique; The TEP (Totally ExtraPeritoneal patch) repair is used as the laparoscopic repair
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Recurrence rate after inguinal hernia repair on primary inguinal herina.
Optimizing Vancomycin Therapy in Children
Condition: Sepsis; Critical Illness; Infections; Drug Toxicity
MeSH terms: Critical Illness; Drug-Related Side Effects and Adverse Reactions
Study type: Observational

Summary: 
      The purpose of Opt Vanc is to evaluate the feasibility of Bayesian dose adaptation, based on
      a previously-developed population pharmacokinetic (PK) model and a single optimally timed PK
      sample, to predict vancomycin area under the curve (AUC) in critically ill children.
    

Detailed description: 
      Opt Vanc is an observational study of critically ill children prescribed IV vancomycin for a
      suspected infection at the Children's Hospital of Philadelphia. This study will evaluate how
      well Bayesian dose adaptation, based on a previously-developed population pharmacokinetic
      (PK) model for vancomycin and a single optimally timed vancomycin concentration, can predict
      vancomycin area under the curve (AUC) in critically ill children. Eligible subjects will be
      prescribed vancomycin and undergo routine therapeutic drug monitoring (TDM) per standard of
      care. At the time of TDM, each subject will have a vancomycin concentration obtained at the
      most informative sampling time to estimate AUC, as determined by the multiple-model optimal
      sampling function in PMetrics (population PK modeling program). Investigators will then
      compare the AUC determined using Bayesian estimation and the subject's optimally timed
      vancomycin concentration to the AUC determined using Bayesian estimation with all available
      concentrations (TDM samples plus the optimally timed sample). Investigators will also examine
      how AUC estimation compares to AUC calculated using standard-of-care methods (ie, log-linear
      equations). Further, Investigators will evaluate how well the population PK model, along with
      a subject's measured covariates and the optimally timed PK sample, can predict a subject's
      future vancomycin AUC.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A total of 20 evaluable participants aged 1-17 years receiving standard of care IV
        vancomycin for a suspected or confirmed infection will be enrolled at Children's Hospital
        of Philadelphia.
      
Biospecimen description: 
      Urine and plasma
Efficacy of Corticosteroid and Local Anesthetic Injections Patients With Concomitant Pes Anserine Bursitis
Condition: Osteoarthritis Knees Both
MeSH terms: Osteoarthritis; Bursitis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      To evaluate the efficiencies of local corticosteroid injections and local anesthetics in
      patients with concomitant pes anserine bursitis and osteoarthritis.
    

Detailed description: 
      Several treatment options have been tried with varying success rates, including nonsteroidal
      anti-inflammatory drugs, physiotherapy modalities, cold application with ice-packs, and
      injection of local anesthetics and/or corticosteroids. Despite a relatively high frequency of
      this painful condition, surprisingly, few studies have evaluated treatment strategies in
      randomized controlled study design. To the best of our knowledge, no study in the literature
      made a comparison of the efficacy of local anesthetic and corticosteroid injections in
      addition to physiotherapy in the treatment of pes anserine bursitis yet. Thus, we aimed to
      compare the treatment efficacies of physiotherapy alone, physiotherapy + local anesthetic
      injection, and physiotherapy + local corticosteroid injection in a randomized controlled
      study design in patients with concomitant osteoarthritis and pes anserine bursitis.
    

Intervention name(s): Lidocaine injection; Corticosteroid injection; Conventional Physical therapy
Intervention type(s): Drug; Drug; Other
Intervention description(s): Lidocaine injection were applied to the most tender point in the pes anserine region by means of the soft tissue infiltration technique only once at the commencement of the treatment period. All injections were performed by the same physician.; Corticosteroid injection were applied to the most tender point in the pes anserine region by means of the soft tissue infiltration technique only once at the commencement of the treatment period. All injections were performed by the same physician.; The study participants underwent a physiotherapy program that included a one-time 15-minute cold therapy using ice packs and closed-kinetic chain quadriceps strengthening program as follows; isometric quadriceps exercise, isokinetic concentric, and eccentric quadriceps exercises with heel slides and squads. These exercises were repeated ten times a day, seven days per week, for eight weeks in total
Other intervention name(s): Jetokain, Edaka İlaç AŞ, Turkey; Diprospan, Merck Sharp Dohme Inc., USA
Intervention MeSH terms: Betamethasone dipropionate, betamethasone sodium phosphate drug combination; Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group I was received physiotherapy+lidocaine injection, Group II was received physiotherapy+betamethasone dipropionate injection, and group III was only received conventional physiotherapy.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain; Knee; Rehabilitation
The Families Addressing Cancer Together Intervention for Parents With Cancer
Condition: Neoplasms; Cancer; Parenting; Communication; Parents; Parent-Child Relations
Study type: Interventional

Summary: 
      The proposed pilot randomized controlled trial will test the FACT (Families Addressing Cancer
      Together) intervention designed to improve parents' confidence and ability to talk about
      their cancer with their minor children. We will enroll 40 patients with cancer who have a
      minor child to participate in this single site, 6-week study. The primary hypothesis being
      tested is that an intervention that assists parents with their communication needs with their
      children can be feasible and acceptable when compared with a wait-list control condition.
    

Detailed description: 
      Parents with cancer are encouraged to be "honest and open" with their minor children about
      their illness. However, many lack access to professional support for their communication
      needs. Without this support, parents with cancer and their children experience avoidable
      psychosocial distress. In order to better support parental communication needs in cancer,
      psychosocial interventions that can be implemented across clinical practice settings are
      needed. To address this gap, we developed and pilot-tested FACT (Families Addressing Cancer
      Together) - a theory-guided, web-based psycho-educational intervention to help parents with
      cancer talk about their illness with their children in a developmentally appropriate way.

      The proposed pilot randomized controlled trial will test the feasibility and acceptability of
      the FACT intervention. We will enroll 40 patients with cancer who have a minor child to
      participate in this single site, 6-week study. The primary hypothesis being tested is that an
      intervention that assists parents with their communication needs with their children can be
      feasible and acceptable when compared with a wait-list control condition. We will also
      explore preliminary effects of the intervention on parental communication and psychological
      outcomes.
    

Intervention name(s): FACT
Intervention type(s): Behavioral
Intervention description(s): Families Addressing Cancer Together (FACT) is a web-based intervention that provides tailored communication support for parents with cancer.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Wilate in Previously Treated Paediatric Patients With Severe Haemophilia A
Condition: Severe Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 3

Summary: 
      A prospective, non-controlled, international, multi-centre phase 3 study to investigate the
      pharmacokinetics, efficacy, safety, and immunogenicity of Wilate in previously treated
      children with severe haemophilia A
    


Intervention name(s): Wilate
Intervention type(s): Drug
Intervention description(s): von Willebrand factor / Factor VIII (plasma derived)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Normal Control Cohort Sample Bank
Condition: Healthy
Study type: Observational

Summary: 
      This study is designed to collect lung washing samples and small pieces of tissue (biopsies)
      from the lungs of people who do not have any allergies or asthma. These samples will be used
      by researchers in the future as control samples to compare to samples from people with
      chronic lung diseases such as allergic asthma or emphysema. Control samples are samples are
      very important in laboratory experiments so that the researchers can tell what may be labeled
      as different or abnormal in samples from people with lung disease.
    

Detailed description: 
      Participants in this study must be between the ages of 18 and 45 years and have no general
      health concerns and do not have allergies or asthma. If qualified, participants will come to
      the study site up to 3 times over about a 3-week period. This study involves answering
      questions about your medical history, having a physical exam, urine pregnancy tests for
      females who might be able to have children, and breathing tests. You will also have a blood
      draw to test for bleeding problems and an allergy skin test to see if you are allergic to
      common things. If it is safe for you, you will have a bronchoscopy. A bronchoscopy is a
      medical procedure to get samples of cells and small pieces of tissue (biopsies) from your
      lungs.

      The study has some risks. The breathing tests may cause you to feel short of breath or dizzy.
      The allergy skin test will itch and cause a reaction like a mosquito bite.

      There are some risks involved with the bronchoscopy. Most people get a sore throat and feel
      tired after the procedure. You may need to feel a little short of breath. There is a very
      rare risk of serious problems.

      Women are able to join this study only if they are not pregnant or breast-feeding. If you
      have plans to become pregnant during the time period in which the study takes place, you
      should not join this study. For women, a urine pregnancy test will be done at the first visit
      and you will be asked to be on birth control. The study staff can talk to you about the type
      of birth control that is all right to use in this study.
    

Time perspective: Prospective
Keywords: bronchoscopy; sample bank; research study volunteer