bioihbjkbjnl/mcl2 huggingface dataset:
BI 671800 in Asthmatic Patients on Inhaled Corticosteroids
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 6 week study to assess the effect of BI 671800 in patients with asthma. It is a
      double blind, parallel arm trial testing the safety and efficacy of BI 671800. The main
      objective is to assess the effect on lung function. The study will also provide data on the
      pharmacokinetics of BI 671800.
    


Intervention name(s): BI 671800; Placebo; Montelukast
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Double blind randomised parallel group study to assess efficacy and tolerability of BI 617800 in patients with symptomatic asthma; Patients receive placebo capsules and/or encapsulated tablets; Double blind randomised parallel group study to assess efficacy and tolerability of BI 671800 in patients with symptomatic asthma
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Study of the Pharmacokinetics, Safety and Tolerability of Topiramate in Infants (Age 1-24 Months) With Refractory Partial-onset Seizures
Condition: Seizures
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics safety and tolerability of
      topiramate in infants aged 1-24 months with refractory partial-onset seizures. Topiramate is
      an antiepileptic drug approved for use in adult and pediatric patients (aged 2 to 16 years)
      with refractory partial onset seizures (POS) with or without secondarily generalized
      seizures, primary generalized tonic clonic seizures, or Lennox-Gastaut syndrome (LGS).
    

Detailed description: 
      This is a open-label, randomized (patients are assigned different treatments based on
      chance), dose comparison, multicenter study of topiramate in infants of age 1-24 months with
      refractory partial-onset seizures (POS). The trial will evaluate the pharmacokinetics,
      safety, and tolerability of topiramate used as additional treatment in infants with
      refractory POS. Topiramate is administered as liquid and sprinkles as adjunct (additional
      treatment) to concurrent anticonvulsant therapy. The study will consist of 4 phases: a
      pretreatment phase that includes screening (up to 7 days) and baseline (1 day), an open-label
      treatment phase (up to 6 weeks), an open-label extension phase (54 weeks), and a
      posttreatment phase (up to 4 weeks). Seizure diaries will be maintained throughout the study
      by the patients' parents, legally acceptable representatives, or caregivers. In the
      open-label treatment phase, patients will be randomly assigned to 1 of 4 treatments:
      topiramate 3, 5, 15, or 25 mg/kg per day. Venous blood samples (four 1 milliliter [mL]
      samples) will be collected on 2 days during the study to determine plasma concentration of
      topiramate. Safety will be evaluated throughout the study by monitoring adverse events and by
      results from clinical laboratory tests (serum chemistry, venous ammonia, hematology, and
      urinalysis), electrocardiograms (ECGs), vital sign measurements (pulse and blood pressure),
      physical examination, neurologic examination, Vineland Scales of Adaptive Behavior, renal
      ultrasound, assessments for adequate food and liquid intake, hyperthermia, oligohydrosis, and
      rash, and take-home records. Liquid or sprinkles form of topiramate, 3,5,15,or 25mg/kg per
      day for 54 weeks.
    

Intervention name(s): Topiramate
Intervention type(s): Drug
Intervention MeSH terms: Topiramate
Keywords: Refractory partial-onset seizures; Infants aged 1-24 months; Pharmacokinetics; Topiramate
Mycophenolate Mofetil in Pediatric Steroid Dependent Nephrotic Syndrome
Condition: Nephrotic Syndrome
MeSH terms: Nephrotic Syndrome; Nephrosis; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Idiopathic nephrotic syndrome is generally responsive to steroid therapy, but some patients
      need other immunosuppressants to reduce steroid dependency. The long-term use should be
      restricted due to adverse effects of cyclosporine, such as hypertension and nephrotoxicity.

      Mycophenolate mofetil for steroid-dependent nephrotic syndrome has been reported to have
      similar efficacy and fewer undesirable effects to other drugs in mainly observational
      studies. To determine the efficacy of mycophenolate mofetil in the management of
      steroid-dependent nephrotic syndrome, the investigators designed this prospective randomized
      controlled study.
    


Intervention name(s): Mycophenolate mofetil
Intervention type(s): Drug
Intervention description(s): Mycophenolate mofetil 20~30mg/kg/day PO until nephrotic syndrome relapse (max. 1 year)
Other intervention name(s): Myrept capsule/tablet
Intervention MeSH terms: Mycophenolic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mycophenolate mofetil; Immunosuppressive Agents; Nephrosis
Mood, Serotonin and Social Interaction
Condition: Mood; Social Behavior
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Rationale: Major depressive disorder (MDD) is a psychiatric disorder whose onset, severity,
      and duration are influenced by interpersonal factors. The serotonin system is known to
      influence MDD risk. Recent research has suggested that serotonin may also play a role in
      regulating social behaviour. Therefore, it would be interesting to study the role of
      serotonin in responses to social stimuli in individuals at risk for MDD.

      Objective: This project aims to study how changes in serotonin alter interpersonal
      functioning in adults with or without a first degree family member diagnosed with MDD. The
      primary goal is to investigate the effect of experimentally lowered brain serotonin levels on
      empathic accuracy. Secondary goals are to determine how this manipulation influences verbal
      and non-verbal communication, cardiovascular function in a social context, and mood. An
      exploratory goal is to investigate how these outcomes are related to genes thought to be
      involved in MDD.
    

Detailed description: 
      see summary
    

Intervention name(s): tryptophan depletion
Intervention type(s): Dietary Supplement
Intervention description(s): tryptophan depletion involves the ingestion of an amino acid mixture that is devoid of tryptophan. on the other day participants receive placebo, being the same mixture but including tryptophan
Intervention MeSH terms: Tryptophan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: mood; empathy; mimicry; emotional reactivity; prosody
Pharmacokinetic Study of a Novel Lipid Formulation of Cannabidiol Compared to a Standard Formulation
Condition: Absorption; Chemicals
Study type: Interventional
Phase: Phase 1

Summary: 
      Cannabidiol (CBD) has been approved as a treatment for rare childhood epilepsies and could be
      an effective treatment for psychotic disorders, anxiety disorders and addictions. It is
      available as an oral liquid and as standard oral capsules.

      The bioavailability of oral cannabidiol is poor (only around 5-10% is absorbed), particularly
      in the fasted state. With food, its absorption is much higher. In one study, a high-fat
      breakfast increased the maximum plasma concentration by 4-5 times. As a result of this food
      effect, when prescribing standard oral formulations of CBD, clinicians should provide advice
      on dosing the drug according to mealtimes, otherwise, there may be an increased risk of side
      effects or limited effectiveness.

      One way to reduce the food effect and improve bioavailability is to use lipid excipients. In
      the present study, the investigators will evaluate CBD at the dose that is effective in
      patients with chronic psychosis (1000mg). The novel formulation will use lipids that are all
      EU pharmacopoeia approved and have been used in medicinal products before.

      The study aims to assess whether a novel lipid formulation can increase the bioavailability
      of oral CBD in the fasting state.
    


Intervention name(s): Standard formulation; Novel formulation
Intervention type(s): Drug; Drug
Intervention description(s): Cannabidiol 1000mg standard formulation, single dose, oral; Cannabidiol 1000mg with lipid matrix, single dose, oral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Treatment of Recurrent HCC With Repeat Hepatectomy,and TACE With AFP Conversion
Condition: Recurrent Hepatocellular Carcinoma
MeSH terms: Carcinoma, Hepatocellular; Recurrence
Study type: Interventional

Summary: 
      The purpose of this study is to compare the treatment of recurrent hepatocellular carcinoma
      with repeat hepatectomy,and transcatheter arterial chemoembolization (TACE) with AFP
      conversion.
    

Detailed description: 
      Though many HCC patients have been benefited from hepatectomy treatment, still the high
      recurrence rate after the hepatectomy led to limited effectiveness.

      This is the first study in same case system on comparison of effectiveness among repeat
      hepatectomy, and TACE with AFP conversion.
    

Intervention name(s): TACE; Hepatectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): In this study we prospectively select some early diagnosed recurrent HCC patients after radical resection with AFP conversion, then they will be treated with transcatheter arterial chemoembolization (TACE); Repeat Hepatectomy after postoperation recurrence
Other intervention name(s): transcatheter arterial chemoembolization
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Recurrent Hepatocellular Carcinoma; transcatheter arterial chemoembolization; AFP conversion
A Comparative Trial Focusing on Injections With the Medical Device DV3316 Pen-injector Versus FlexPen®
Condition: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to compare Injections with the
      Medical Device DV3316 Pen-injector versus FlexPen®.
    


Intervention name(s): FlexPen®; DV3316 pen-injector; placebo
Intervention type(s): Device; Device; Drug
Intervention description(s): For subcutaneously (s.c. under the skin) injection.; For subcutaneously (s.c. under the skin) injection.; For subcutaneously (s.c. under the skin) injection
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
The Safety and PK Characteristics of the Co-administration of JLP-2002 and Comparator in Healthy Volunteers
Condition: Overactive Bladder(OAB)
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, open-label, single-dose, replicate crossover study to compare the
      pharmacokinetics and safety in healthy adult volunteers following oral administration of
      JLP-2002
    

Detailed description: 
      A randomized, open-label, single-dose, replicate crossover study
    

Intervention name(s): JLP-2002; Comparator
Intervention type(s): Drug; Drug
Intervention description(s): administration of JLP-2002; administration of comparator
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Maintenance Therapy of Apatinib After Chemoradiotherapy in Metastatic Nasopharyngeal Carcinoma
Condition: Nasopharyngeal Neoplasms
MeSH terms: Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is to evaluate the efficacy and safety of Apatinib as maintenace therapy for
      Nasopharyngeal Carcinoma With Metastasis after Chemoradiotherapy, including progress free
      survival(PFS)、overall survival (OS)、Quality of life score (QoL) and evaluation of drug
      safety.
    

Detailed description: 
      In locally advanced nasopharyngeal carcinoma(NPC), although radiotherapy and chemotherapy has
      been given, patients still locally recurrence and distant metastasis. There is no standard
      treatment recommendation for metastatic NPC who failed to chemoradiotherapy therapy. Apatinib
      has been approved as a second-line treatment for advanced gastric cancer. Several phase III
      studies of liver cancer, non small cell lung cancer and other tumors also showed apatinib has
      less toxicities and better tolerance. However, the clinical application of apatinib in
      nasopharyngeal carcinoma is still lack of evidence-based medicine. And this trial is designed
      to investigate the efficacy and safety of apatinib as maintenance therapy after
      chemoradiotherapy in nasopharyngeal carcinoma with metastasis.
    

Intervention name(s): Apatinib
Intervention type(s): Drug
Intervention description(s): Apatinib, also known as YN968D1, is a tyrosine kinase inhibitor that selectively inhibits the vascular endothelial growth factor receptor-2 (VEGFR2, also known as KDR). It is an orally bioavailable, small molecule agent which is thought to inhibit angiogenesis in cancer cells; specifically apatinib inhibits VEGF-mediated endothelial cell migration and proliferation thus blocking new blood vessel formation in tumor tissue. This agent also mildly inhibits c-Kit and c-SRC tyrosine kinases.
Other intervention name(s): YN968D1; apatinib mesylate tablets
Intervention MeSH terms: Apatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Determine the Effectiveness of a Self-regulation Program to Treat Pediatric Obesity
Condition: Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The objective of this study is to pilot test, evaluate and compare the effects of Cue
      Reactivity and Sensitivity Training (CRST) and Children's Appetite Awareness Training (CAAT)
      in 48 children aged 8-12 years old. The central hypothesis is that CRST and CAAT will reduce
      eating in the absence of hunger in overweight children immediately following treatment and
      6-months post treatment.

      The primary aim of this proposed study is to evaluate the efficacy and compare the
      effectiveness of Cue Responsivity and Sensitivity Training (CRST) or Children's Appetite
      Awareness Training (CAAT) in decreasing eating in the absence of hunger (EAH) in overweight
      children. Following this first intervention, a second intervention to determine the efficacy
      of a combination program (combined CAAT & CRST) will be implemented.

      The secondary aim of this study is to evaluate change in the following related measures for
      both children and adults who participated in CRST, CAAT, and the combination program: BMI for
      age, food intake, perceptions of control over eating, and self-efficacy in managing high-risk
      food situations.
    


Intervention name(s): CAAT: Appetite Awareness; CRST: Volcravo; Combined CAAT and CRST program
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants in this Children's Appetite Awareness Training (CAAT) group learn to get in touch with the internal cues of hunger - aka the "hunger meter" - and practice skills to get back in touch with these internal cues of true hunger and fullness. Sessions occur once a week for 8 weeks.; Participants in this Cue Reactivity and Sensitivity Training (CRST) group learn about how external cues can affect when and how much we eat (aka "volcravo - the craving volcano"). Over 8 weekly sessions, they practice skills to ride out the cravings external cues can cause.; Participants meet weekly for 14 weeks to learn about both Children's Appetite Awareness Training (CAAT) and Cue Reactivity and Sensitivity Training (CRST) - i.e. appetite awareness and external cues that affect food intake.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; pediatric; childhood; overweight
Healthy Transitions: Menopause Effect on Obesity, Energy Balance, and Insulin
Condition: Menopause
Study type: Observational

Summary: 
      The purpose of this study is to determine the effect of menopause on obesity, energy balance,
      and insulin in postmenopausal, obese women.
    

Detailed description: 
      The effect of menopause on body composition and cardiovascular risk in healthy caucasian
      women has been the subject of much study. In contrast, there are few data available on
      menopause in African-American women. Since menopause is associated with potentially
      preventable health risks in women, this proposal is aimed at characterizing the
      perimenopausal period in terms of body fat, energy balance, and insulin action in both
      caucasian and African-American women.

      The study will address 4 general hypotheses:

        -  Menopause increases both total and visceral abdominal fat

        -  Changes in body composition and body weight at menopause are mediated, at least in part
           by changes in 24-hour energy expenditure and/or food intake

        -  Menopause results in decreased insulin sensitivity that may predispose certain women to
           develop diabetes later in life

        -  African-American women may respond to the shifts in reproductive hormones at menopause
           differently than caucasian women.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pennington Biomedical Research Center is located in Baton Rouge, Louisiana, adjacent to the
        medical services district of the Regional Medical Center. The city of Baton Rouge is the
        home of state government, the 27,000-student Louisiana State University, the 9,000-student
        Southern University and a large petrochemical industry. Lacking the traditional active
        urban "downtown", the region is characterized by the suburban pattern of single family
        subdivisions and small apartment complexes. The population within a 7 parish (i.e. county)
        area is 635,202. The population of East Baton Rouge Parish is 380,105 with an ethnic
        distribution of 62% Caucasian, 35% African-American, 1% Asian, and <1% Native American and
        Hispanic. There are 34,885 people over age 65 and 251,586 between ages 16-65 yr.
      
Keywords: Insulin Sensitivity; Total abdominal fat; Visceral abdominal fat; Reproductive Hormones; Menopause; Diabetes; Fat Distribution; Sex Hormones
Effect of Social Media Support and Financial Incentives on PrEP Adherence
Condition: Pre-Exposure Prophylaxis
Study type: Interventional

Summary: 
      The purpose of this study is to determine if social media support and financial incentives
      improve adherence to Truvada as PrEP in African American, Latino and Asian MSM aged 18 to 24
      living in the Washington, DC area who are at high risk for HIV acquisition.
    


Intervention name(s): Financial Incentive; Social Media Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will receive a $50 gift card at 3- and 6- month follow-up visits.; Participants will be invited to a study Facebook group which will have links to PrEP information and provide a forum for participants to ask questions and communicate their experience with PrEP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies
Condition: Malignancies; Acute Lymphoblastic Leukemia (ALL); Acute Myeloid Leukemia (AML); Non-Hodgkin's Lymphoma; Neuroblastoma
MeSH terms: Leukemia; Leukemia, Myeloid, Acute; Neoplasms; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Neuroblastoma
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label, global, multi-center study to evaluate the safety and pharmacokinetics of
      venetoclax monotherapy, to determine the dose limiting toxicity (DLT) and the recommended
      Phase 2 dose (RPTD), and to assess the preliminary efficacy of venetoclax in pediatric and
      young adult participants with relapsed or refractory malignancies.
    


Intervention name(s): chemotherapy; venetoclax
Intervention type(s): Drug; Drug
Intervention description(s): Dexamethasone and/or vincristine and/or pegasparaginase OR cytarabine and/or etoposide and/or pegasparaginase; tyrosine kinase inhibitor; cytarabine OR azacitidine OR decitabine; rituximab and/or dexamethasone and/or vincristine; cyclophosphamide and/or topotecan; Oral tablet for participants; Tablet for oral suspension (participants who cannot swallow a tablet)
Other intervention name(s): ABT-199; GDC-0199; Venclexta
Intervention MeSH terms: Venetoclax
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer; Venetoclax; pediatric; relapsed or refractory; Venclexta