bioihbjkbjnl/mcl2 huggingface dataset:
A Safety, PK, PD and Food Effect Study of URC102 in Healthy Adults and Patients With Renal Impairment
Condition: Healthy, Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase 1 clinical trial to evaluate safety, PK/PD profiles and food effects of URC102 in
      patients with renal impairment and healthy people.
    

Detailed description: 
      This trial will evaluate

        1. in patients with renal impairment: the safety, pharmacokinetics and pharmacodynamics
           after single oral administration of URC102 under fasted conditions.

        2. in healthy adult subjects: the safety, pharmacokinetics and pharmacodynamics of 2 single
           doses of URC102 in the morning after fasting or after a high-fat breakfast. The 2 doses
           will be separated by a washout period.
    

Intervention name(s): URC102; URC102
Intervention type(s): Drug; Drug
Intervention description(s): tablet; tablet
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel study between groups (crossover study within healthy patients)
Masking: None (Open Label)
Primary purpose: Treatment
Study To Determine The Effect Of Food And Strong CYP3A4 Enzyme Inhibitor On PF-04449913 Drug Levels
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The study aims to determine what effect a high fat meal will have on the drug exposure of
      PF-04449913. The study also aims to determine the effect of a strong enzyme (CYP3A4)
      inhibitor on drug exposure of PF-04449913.
    


Intervention name(s): PF-04449913, ketoconazole; PF-04449913, ketoconazole
Intervention type(s): Drug; Drug
Intervention description(s): Subjects receive a 200 mg oral dose of PF-04449913 under fasted conditions with washout, then single 200 mg oral dose of PF-04449913 under fed with washout and finally a single 200 mg dose 0f PF-04449913 following dosing to steady state with ketoconazole; Subjects receive a 200 mg oral dose of PF-04449913 under fed conditions with washout, then single 200 mg oral dose of PF-04449913 under fasted with washout and finally a single 200 mg dose of PF-04449913 following dosing to steady state with ketoconazole
Intervention MeSH terms: Ketoconazole
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PF-04449913; Food Effect; Drug-drug interaction; CYP3A4 inhibitor; Pharmacokinetics
Efficacy and Safety Study of Escitalopram Augmentation in Treatment Resistant Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders; Schizophrenia, Treatment-Resistant
Study type: Interventional
Phase: Phase 4

Summary: 
      A primary hypothesis to be explored here is that, given its pharmacodynamic profile and
      hypothesized mechanisms associated with schizophrenia, escitalopram will, in comparison to
      placebo, be effective when added to risperidone or olanzapine treated group in reducing the
      severity of resistant symptoms, particularly existing subsyndromal anxiety and depression.
    

Detailed description: 
      The objective of this trial is to determine the efficacy and safety of augmenting risperidone
      or olanzapine with escitalopram for treatment of symptoms of schizophrenia in patients with
      incomplete response to adequate trials of either of the two antipsychotic medications. To our
      knowledge, this is the first double blind randomized study designed to examine the potential
      augmentation benefit of escitalopram combined with a commonly used atypical agent in chronic
      schizophrenic patients with incomplete response to risperidone or olanzapine. The current
      proposal offers the possibility to test the efficacy of augmentation treatment in a
      controlled fashion with clinical and biological variables used as indicators of response and
      tolerability. From a broader perspective, it would test the hypothesis of potential validity
      of SSRI augmentation strategy in treatment of resistant symptoms of schizophrenia.
    

Intervention name(s): escitalopram
Intervention type(s): Drug
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: schizophrenia; depression; anxiety; negative symptoms
Dietary Intake of Tryptophan and Metformin Response
Condition: Metformin Response; Fasting Glucose; Tryptophan Concentration; Metformin Concentration; Diet Tolerability
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study will examine the influence of dietary intake of tryptophan on response to
      metformin. The investigators hypothesize that dietary tryptophan alteration will influence
      metformin response.
    


Intervention name(s): Metformin; Low tryptophan diet; High tryptophan diet
Intervention type(s): Drug; Other; Other
Intervention description(s): 2 doses of 500 mg metformin given approximately 12 hrs apart
Intervention MeSH terms: Metformin; Tryptophan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study Evaluating SRA-333 in Mild to Moderate Alzheimer's Disease (AD)
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the safety and tolerability of multiple ascending fixed oral doses of SRA-333 in
      subjects with mild to moderate Alzheimer's disease.
    


Intervention name(s): SRA-333
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
An Extension Study of ABT-199 in Subjects With Advanced Non-Hodgkin's Lymphoma
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, multicenter, extension study. Subjects with non-Hodgkin's
      lymphoma (NHL) (excluding chronic lymphocytic lymphoma [CLL], small lymphocytic lymphoma
      [SLL], and mantle cell lymphoma [MCL]) who completed a prior ABT-199 study, or were active
      and assigned to ABT-199 when the study was completed, may roll over into this extension
      study. Subjects will receive ABT-199 during this study.
    


Intervention name(s): ABT-199
Intervention type(s): Drug
Intervention description(s): ABT-199 continuous once daily dosing
Other intervention name(s): GDC-0199
Intervention MeSH terms: Venetoclax
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ABT-199; Cancer; GDC-0199; non-Hodgkin's lymphoma; Relapsed; Refractory; Safety
Investigation of the Accelerated Healing and Anti-scarring Potential of Avotermin (Juvista) in Split Skin Graft Donor Sites
Condition: Cicatrix; Wound Healing
MeSH terms: Cicatrix
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the accelerated-healing potential of injection or
      injection plus topical application of Juvista to minor split skin grafts (SSG).
    

Detailed description: 
      Subjects were allocated into three groups (Group 1, Group 2 and Group 3) with all subjects
      receiving two 3cm2 SSG donor sites, one to each side of the lower back. Before wounding on
      Day 0, each site was randomised to receive either an intradermal injection of Juvista
      (50ng/100μl/cm2), an intradermal injection of Placebo (100μl/cm2) or no injection (Standard
      Care). After wounding, subjects allocated to Group 2 and Group 3 also received topical
      Juvista (100ng/200μl/cm2), topical Placebo (200μl/cm2) or Standard Care (Tegaderm dressing
      only). Topical Juvista and Placebo were held within a Granuflex ring dressing and sealed with
      a sterile Tegaderm dressing.

      On Day 1, subjects in Group 2 and Group 3 received a further topical application of Juvista,
      Placebo or Standard Care according to the same treatment randomisation as Day 0.

      Punch biopsy samples of healing SSG donor sites were harvested from Group 3 subjects on Day
      3, 5, 7 or 10, and preserved for histological analysis.

      The final study visit for Group 3 subjects was the day of the biopsy visit. Subjects in Group
      1 and Group 2 underwent scar assessments at the first follow-up at Month 1 and at Months 2,
      3, 4, 5, 6, 9 and 12.
    

Intervention name(s): Avotermin; Placebo; Avotermin; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Intradermal Juvista at 50ng/100μl/cm2 of SSG donor sites (3cm2) once just prior to wounding; Intradermal injection of Placebo at 100μl/cm2 of SSG donor site (3cm2) once just prior to wounding; Intradermal Juvista at 50ng/100μl/cm2 of SSG donor site once just prior to wounding, followed by topical Juvista at 100ng/200μl/cm2 after wounding and again at Day 1; Intradermal placebo at 100μl/cm2 of SSG donor site once just prior to wounding, followed by topical placebo at 200μl/cm2 after wounding and again at Day 1
Other intervention name(s): Juvista; TGF beta 3; RN1001; Juvista; TGF beta 3; RN1001
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cicatrix; Scar; Wound healing; Avotermin; TGF beta 3; Juvista; RN1001
Phase 2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat
Condition: Moderate or Severe Submental Fullness
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase 2 trial to evaluate the safety and potential efficacy of one concentration of
      deoxycholic acid injection, given in three dosing paradigms, compared to placebo for the
      reduction of submental fat (fat beneath the chin).
    


Intervention name(s): Deoxycholic Acid Injection; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
Other intervention name(s): ATX-101
Intervention MeSH terms: Deoxycholic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Examining the Efficacy of Kiko Exercises on the Prevention of Migraine Headaches
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This pilot study hopes to show that after 3 months of Kiko training, Kiko naive patients with
      migraine will have a decrease in the frequency and severity of their migraines.
    

Detailed description: 
      3.1 Study Design

      Eligible subjects in this pilot study will be taught a series of Kiko exercises. Subjects who
      meet inclusion and exclusion criteria at the screening visit will be given a diary in which
      they will document their migraine frequency and severity for one month. Once subject diaries
      are complete, subjects will meet for a group lesson to learn the background of Kiko and study
      exercises. A DVD or videotape will be issued for subjects to use during practice at home.
      Subjects will maintain a diary of their migraine headaches, as well as a diary of their
      exercise routines. Subjects will meet weekly to reinforce training and encourage training
      continuation. Diaries will be collected at the end of the first, second, and third months.
    

Intervention name(s): Kiko exercises-combines breathing and movement
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Migraine; Kiko; Qigong; Relaxation; Exercise
Immune Response to Respiratory Syncytial Virus (RSV) in Health Care Workers
Condition: Healthy
Study type: Observational

Summary: 
      Respiratory Syncytial Virus (RSV) is a human restricted pathogen and is the single most
      important cause of severe respiratory illness in infants and young children, a major cause of
      infantile bronchiolitis and is the most frequent cause of hospitalization of infants and
      young children in industrialized countries. Severe RSV infection early in life is associated
      with an increased risk of subsequent recurrent wheezing and asthma. There are few
      population-based estimates of the incidence of RSV disease from developing countries, but the
      existing data clearly indicates that the virus accounts for a high proportion of Acute
      Respiratory Infections (ARI) in children. Studies in Brazil, Colombia and Thailand suggest
      that RSV causes 20-30% of ARI cases in children from 1-4 years of age, a proportion similar
      to that in industrialized countries, and WHO has estimated the global RSV disease burden at
      64 million cases and 160 000 deaths every year. RSV also causes severe disease in elderly and
      immune-compromised adults, and the burden of RSV disease in the elderly is comparable to that
      of seasonal influenza. The economic impact of RSV-related disease in adults estimated to be
      greater than that of influenza in relation to numbers of days lost from work.

      The development of a safe and effective vaccine against RSV would benefit greatly from data
      on the immune responses in healthy adults naturally exposed to the virus. RSV infection has
      been shown to increase and induce short-lived circulating antibody secreting cells and
      produce an increase in the RSV specific antibody titres but very limited data is available on
      the cellular immune responses induced by RSV during natural infection in healthy adults. The
      existence of cell mediated immune response against RSV in humans has been described but
      characterization of this response remains poor and simultaneous analysis of several
      immunological parameters have not been attempted in an RSV exposed population before.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy health care personnel working in a pediatric ward and healthy volunteers from
        non-NHS staff
      
Biospecimen description: 
      The humoral and cellular immune response to RSV exposure. To characterise these further some
      analysis of HLA typing my occur.
    
Keywords: RSV; Immune response
Adjuvant Chemotherapy Trial of TS-1 for Gastric Cancer (ACTS-GC)
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This controlled study is designed to evaluate the efficacy of TS-1 on survival compared with
      surgery alone. Patients will be randomly assigned to receive either surgery alone or surgery
      followed by treatment with TS-1 within 45 days after curative resection (curability A or B).
      To assess the efficacy, data on recurrence and survival will be collected from the time of
      enrollment until 5 years after surgery. To evaluate safety, data on adverse events will be
      collected from the time of enrollment until 1 year after surgery.
    


Intervention name(s): TS-1 (S-1); Surgery
Intervention type(s): Drug; Procedure
Intervention description(s): 80 mg of oral S-1 per square meter of body-surface area per day was given for 4 weeks and no chemotherapy was given for the following 2 weeks; Stage II or III gastric cancer who underwent gastrectomy were assigned to surgery only
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stomach cancer
Modeling and Predicting Real World Behavior Using Mobile Sensor Data on Patients With Major Depressive Disorder
Condition: Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The purpose of this study is to validate the effectiveness of using an integrated mobile
      sensing platform to deliver large-scale data-driven interventions to patients with
      depression.
    

Detailed description: 
      This study is a smartphone-based, randomized, single-blind, controlled parallel-

      design study with two intervention arms and one control arm. The two intervention arms

      will receive in-app messages and phone-based support, which will be triggered by

      participant's self-reported surveys and passive behavioral data gathered through a

      smartphone app. The study will include a nationwide sample of adult (18 years or older)

      smartphone users, who are currently experiencing depressive symptoms. The primary

      outcome will be decrease in depression symptom severity, as measured by the 9-item

      Patient Health Questionnaire, over 6 months.
    

Intervention name(s): Behavioral-data driven support
Intervention type(s): Other
Intervention description(s): Phone-based support (e.g. triaging of the situation, emotional support, and guidance on next steps for the patient) and in-app support (health education content based on cognitive behavioral therapies, mindfulness, and behavioral activation)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Study of Evinacumab (REGN1500) in Caucasian and in Japanese Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to compare the safety and tolerability of subcutaneous
      (SC) and intravenous (IV) doses of evinacumab in healthy Japanese and Caucasian subjects.
    


Intervention name(s): Evinacumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SC or IV administration of Evinacumab; Matching placebo
Other intervention name(s): REGN1500
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Performance and Safety of Vaginal Ring Applicator in Healthy Females (MK-8342A-063)
Condition: Contraception: Optional Applicator for Insertion of Vaginal Ring
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to assess the performance and safe use of the vaginal ring
      applicator as an optional aid for insertion of a placebo vaginal ring into the vagina in
      healthy women
    


Intervention name(s): Placebo vaginal ring; Single-use, non-sterile applicator
Intervention type(s): Drug; Device
Intervention description(s): Drug-free placebo vaginal ring; Single-use, non-sterile, plastic applicator for insertion of vaginal ring.
Other intervention name(s): NuvaRing; NuvaRing Applicator
Intervention MeSH terms: NuvaRing; Ethinyl Estradiol; Desogestrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Selumetinib (AZD6244: ARRY-142886) (Hyd-Sulfate) in Metastatic Uveal Melanoma (SUMIT)
Condition: Metastatic; Uveal Melanoma
MeSH terms: Melanoma; Uveal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Selumetinib therapy in patients with metastatic uveal melanoma.
    

Detailed description: 
      A randomised double-blind study to assess the efficacy of selumetinib (AZD6244, Hyd-Sulfate)
      in combination with Dacarbazine compared with placebo in combination with Dacarbazine as
      first systemic therapy in patients with metastatic uveal melanoma (SUMIT)
    

Intervention name(s): 75mg selumetinib; placebo; Dacarbazine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): selumetinib tablets p.o. twice daily taken in combination with dacarbazine 1000mg/m2 iv on day 1 of every 21-day cycle.; placebo tablets p.o. twice daily taken in combination with dacarbazine 1000mg/m2 iv on day 1 of every 21-day cycle.; dacarbazine 1000mg/m2 iv on day 1 of every 21-day cycle taken in combination with either selumetinib or placebo tablets p.o. twice daily.
Intervention MeSH terms: Dacarbazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: uveal melanoma
A 12-Week Efficacy Study of Paracetamol 1000mg Sustained-release Tablets in Patients With Osteoarthritis
Condition: Pain
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine whether paracetamol 1000 mg sustained-release (SR)
      tablets administered orally, twice daily are effective and safe in the treatment of patients
      with osteoarthritis of the knee or hip.
    


Intervention name(s): Paracetamol 1000 mg SR tablets; Paracetamol 665 mg SR tablets; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Two paracetamol 1000 mg SR tablets administered orally two times a day plus two placebo-matched paracetamol 665 mg SR tablets administered orally three times a day for 12 weeks.; Two paracetamol 665 mg SR tablets administered orally three times a day plus two placebo-matched paracetamol 1000 mg SR tablets administered orally two times a day for 12 weeks.; Two placebo-matched paracetamol 665 mg SR tablets administered orally three times a day plus two placebo-matched paracetamol 1000 mg SR tablets administered orally two times a day for 12 weeks.
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment