bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate Potential Predictors of Relapse in Participants With Major Depressive Disorder (MDD)
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Observational

Summary: 
      The purpose of this study is to identify if there are self-reported or objective measures
      related to mood parameters that can predict near-term relapse (within 1 month or at another
      identified time point before meeting the criteria for relapse) or early symptomatic changes
      indicative of relapse prodrome in major depressive disorder (MDD).
    

Detailed description: 
      This is a prospective, multicenter, longitudinal, single-cohort, observational study in
      participants with MDD who have responded to, and are continuing to respond to and receive, an
      oral antidepressant treatment regimen. The study will consist of 2 parts: a screening phase
      of up to 2 weeks, and an observational phase of variable duration.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants with major depressive disorder who have responded to an oral antidepressant
        regimen will be observed.
      
Keywords: Depressive Disorder, Major; Depression; Anti-Depressant; Observational
A Study to Evaluate the Efficacy and Safety of ASP015K in Moderate to Severe Rheumatoid Arthritis Subjects
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to evaluate the efficacy and safety of ASP015K monotherapy and to evaluate the
      dose-dependent response of ASP015K in moderate to severe Rheumatoid Arthritis (RA) subjects
      given ASP015K for 12 weeks.
    

Detailed description: 
      This is a Phase 2b, randomized, double-blind, parallel-group, placebo-controlled,
      dose-finding, monotherapy, multi-center study with once daily oral ASP015K or matching
      placebo in subjects with moderate to severe RA, with or without prior antirheumatic
      medication, and regardless of responsiveness to the medication.

      The study is comprised of up to a 4-week Screening period, a 12-week Treatment period and a
      4-week Follow-up period.

      Subjects in each treatment group will take ASP015K or matching placebo orally, once daily,
      after breakfast for 12 weeks after the screening period.
    

Intervention name(s): peficitinib; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): ASP015K
Intervention MeSH terms: Peficitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; ASP015K
Single-blind, Dose-ranging Study of Novel Swine Influenza Virus Vaccine in Japanese Adult Subjects
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study is to identify the preferred vaccine dosage (of antigen and adjuvant) and schedule
      (one or two administrations) of the cell-derived H1N1sw monovalent vaccine in healthy adults
      based on EMEA/CHMP criteria, and safety & tolerability.
    


Intervention name(s): Adjuvanted cell-derived, inactivated novel swine origin A/H1N1 monovalent subunit influenza virus vaccine
Intervention type(s): Biological
Intervention description(s): High dose group and low dose group of adjuvanted vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Influenza A; H1N1 subtype; Adult; Vaccine; Adjuvant; Swine-Origin Influenza A H1N1 Virus
CSD170303: Study to Assess Nicotine Uptake in Smokers From Electronic Cigarettes
Condition: Smoking
Study type: Interventional

Summary: 
      To determine the rate and amount of nicotine uptake with 10-minute ad libitum use of four
      different marketed electronic cigarettes. Furthermore, to measure overall product liking by
      subjects to assess potential willingness to seek out the Electronic Cigarette (EC) again in
      the future.
    

Detailed description: 
      This will be a single-center, randomized, open-label, parallel study during which up to 140
      healthy adult subjects, consisting of 35 subjects per marketed EC product, will be enrolled.
      Subjects will be evaluated for plasma nicotine uptake, as well as overall product liking. The
      study will involve the use of four (4) marketed EC products in tobacco consumers who are
      exclusive smokers (i.e., naïve EC users) or dual users of cigarettes and ECs (i.e.,
      intermittent EC users).
    

Intervention name(s): FT21092; FT21093; FT21096; FT21097
Intervention type(s): Other; Other; Other; Other
Intervention description(s): An electronic cigarette; An electronic cigarette; An electronic cigarette; An electronic cigarette
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
A Computerized Intervention for Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The primary purpose of this study is to examine how much change in depressive symptoms will
      be observed in persons who use an electronic Problem Solving Treatment (imbPST) compared to a
      control group at pre-, mid-point, and post-test assessments.
    

Detailed description: 
      An interactive multimedia computer-based treatment program was developed to provide an
      electronic version of problem solving therapy for depression (imbPST). The program was
      entirely automated and did not require the involvement of a live clinician, even though it
      was designed to provide a "virtual therapy" experience that feels more like interacting with
      a person than with a computer. The imbPST program was built to help individuals who did not
      have access to traditional therapy due the living conditions or individual preferences (e.g.
      rural, poor and persons desiring privacy or with significant time constraints). This
      computer-based treatment of depression offered several advantages. It can be used anywhere
      without a therapist present, and offered a standardized and consistent therapeutic approach.

      The aim of this study is to reduce symptoms of depression in subjects through the use of a
      new, electronic Problem Solving Treatment (imbPST). Adult participants with moderate to
      severe depression symptoms are randomly assigned to either treatment or a wait-list
      condition. The Beck Depression Inventory-II was used as the primary outcome measure
    

Intervention name(s): Interactive Media-Based Problems Solving Treatment
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A First-in-Human Study With XAB05 in Healthy Subjects
Condition: Infection, Bacterial
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a randomized, placebo-controlled, first in human, single ascending dose Phase 1
      study
    

Detailed description: 
      This study is a First in Human (FIH) single ascending dose study with XAB05 to evaluate
      safety, tolerability, PK and exploratory markers of efficacy for XAB05 in healthy volunteers.
    

Intervention name(s): Experimental
Intervention type(s): Biological
Intervention description(s): Participants will receive a single IV infusion in a double blind manner
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Study With Healthy Japanese and Non-Asian Participants With BMS-986231
Condition: Heart Decompensation, Acute
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this Phase 1 study is to evaluate the safety, tolerability, PK, and
      pharmacodynamics (PD) of BMS-986231 in healthy Japanese and Non-Asian participants. There is
      no formal hypothesis to be statistically tested.
    


Intervention name(s): BMS-986231; BMS-986231 Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Tackling Intrusive Traumatic Memories After a Difficult Birth
Condition: Posttraumatic Stress Disorder; Intrusive Traumatic Memories
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      This proof-of-principle study aims to investigate the effects of a brief behavioural
      procedure including a computerized visuospatial task (the computer game "Tetris") preceded by
      a reactivation of the traumatic memory of childbirth, on birth-related intrusive traumatic
      memories and other postpartum posttraumatic stress symptoms. Women who report birth-related
      intrusive memories after 6 weeks postpartum will monitor their intrusive traumatic memories
      in a daily diary. After two weeks of diary, they will meet a psychologist to briefly evoke
      the memory of their birth, and receive a brief behavioural procedure including playing
      Tetris. Participants will then continue to complete an intrusive traumatic memory diary
      during two weeks. It is predicted that they will report fewer intrusive memories in the two
      weeks following the intervention, compared to the two weeks before. This will inform the
      potential future development of a simple computerized intervention procedure to reduce
      distressing psychological symptoms after traumatic childbirth.
    


Intervention name(s): Brief behavioural procedure including a computerized visuospatial task (computer game "Tetris")
Intervention type(s): Behavioral
Intervention description(s): Brief behavioural procedure including a computerized visuospatial task (the computer game "Tetris") preceded by a reactivation of the traumatic memory of childbirth
Intervention model: Single Group Assignment
Intervention model description: Single group pre-post study
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics of Ledipasvir/Sofosbuvir in Hepatitis C Virus-Infected Children With Hematological Malignancy
Condition: Hepatitis C, Chronic; Hematologic Malignancy
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Neoplasms; Hematologic Neoplasms; Hepatitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a prospective, controlled, open-label, pharmacokinetic study. This study aims at
      studying the PK of ledipasvir, sofosbuvir, and GS-331007 metabolite in HCV infected children
      with hematological malignancy.

      In this study, patients in both treatment groups will receive 12 weeks of treatment with a
      ﬁxed-dose combination tablet containing 45 mg of ledipasvir and 200 mg of sofosbuvir
      (LDV/SOF) orally, once daily with food.
    

Detailed description: 
      In this study, patients in both treatment groups will receive 12 weeks of treatment with a
      ﬁxed-dose combination tablet containing 45 mg of ledipasvir and 200 mg of sofosbuvir
      (LDV/SOF) orally, once daily with food, as prescribed by the attending physician.

      Twelve eligible HCV-infected patients with hematological malignancy and 12 matching HCV
      control patients without haematological malignancy or co-morbidities will be enrolled in the
      study.

      At baseline, careful history of the recruited patients including demographic characteristics
      (age, height, weight, and gender), comorbidities, medication history, familial history,
      social history, blood transfusion history, time on maintenance chemotherapy, and baseline
      laboratory tests will be documented. The baseline laboratory tests will include renal
      function tests (serum creatinine), liver function tests (bilirubin, albumin, AST, and ALT),
      international normalized ratio (INR), alpha fetoprotein (AFP), complete blood count (CBC),
      degree of liver fibrosis by Fibroscan, and viral load by PCR.

      Followup will be done for all participants at baseline, after 12 weeks of treatment, and
      after 12 weeks from the end of treatment. A Forth visit will be done after 10 days of
      treatment for the evaluation of the steady state PK parameters of LDV\SOF in those patients.
    

Intervention name(s): Ledipasvir / Sofosbuvir Oral Product
Intervention type(s): Drug
Intervention description(s): 45 mg of ledipasvir and 200 mg of sofosbuvir orally, once daily with food
Other intervention name(s): LDV\SOF
Intervention MeSH terms: Sofosbuvir; Ledipasvir; Ledipasvir, sofosbuvir drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C virus; Pharmacokinetic Modeling; Pharmacokinetics; Pediatrics; Leukemia; Ledipasvir; Sofosbuvir; Antiviral Drugs
A Research Study Investigating NNC0247-0829 for Weight Management in People With Overweight or Obesity
Condition: Overweight; Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      This study looks at NNC0247-0829 (a potential new medicine) for weight management in people
      with overweight or obesity. The study looks at how NNC0247-0829 works in the body.
      Participants will either get NNC0247-0829 or placebo (a 'dummy' medicine) - which treatment
      is decided by chance. NNC0247-0829 is an experimental medicine which has not been approved by
      the US FDA. Participants will get either 1 injection or a total of 4 injections (one week
      apart) by a study nurse at the clinic depending on what group they are in. The study will
      last for about 18 months, but participation will last from 11 to 23 weeks. This will depend
      on the group participants are in. Participants will attend 8 to 14 visits at the clinic with
      the study staff. Some participants will have one 16-day, 15-night visit and one 2-day,
      1-night visit. Others will have two 2-day, 1-night visits. At all visits except one,
      participants will have blood tests and other checks. They will be asked about their health,
      medical history and habits including mental health questionnaires.
    


Intervention name(s): NNC0247-0829; Placebo (NNC0247-0829)
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive either single or multiple doses given subcutaneously (s.c., under the skin) in a lifted fold of the stomach skin. Dose level and number of doses will depend on the cohort.; Participants will receive either single or multiple doses of placebo given s.c. in a lifted fold of the stomach skin.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: First human dose trial; a single-centre, placebo-controlled, double-blind (within cohorts), randomised SD and MD ascending dose trial with a sequential trial design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase I Crossover Study of the Hemodynamic Interactions of Avanafil & Alcohol in Healthy Male Subjects.
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is primarily to evaluate whether taking avanafil with alcohol
      causes the blood pressure to fall.
    

Detailed description: 
      The trial is a single-centre double-blind, randomized, placebo-controlled, three-period,
      three-way crossover study, in which each subject will be randomized to receive each of the
      following three treatments with a washout period of at least 5 days between treatments:

        -  Treatment A: a single oral dose of one 200 mg avanafil tablet plus an oral dose of
           alcohol drink mixed with fruit juice (0.5 g of absolute ethanol per kilogram of body
           weight).

        -  Treatment B: a single oral dose of one placebo tablet plus an oral dose of alcohol drink
           mixed with fruit juice (0.5 g of absolute ethanol per kilogram of body weight).

        -  Treatment C: a single oral dose of one 200 mg avanafil tablet plus an oral dose of
           placebo drink mixed with fruit juice.

      For each treatment period, Dinamap (or DataScope) automatic measurements of supine blood
      pressure and pulse rate will be taken pre-dose and every 15 minutes for 4 hours post-dose.
      Alcohol levels using a breathalyzer will be measured at pre-dose and up to 8 hours post dose
      during all 3 treatments by designated unblinded personnel. Subjects should be supine for at
      least 5-10 minutes before the blood pressure and heart rate measurement.
    

Intervention name(s): avanafil; alcohol; avanafil
Intervention type(s): Drug; Other; Drug
Intervention description(s): 200 mg avanafil tablet QD plus 0.5 g/kg alcohol; 0.5 g/kg alcohol; 200 mg avanafil tablet QD
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
PET Imaging and Olanzapine Treatment in Borderline Personality Disorder
Condition: Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Study type: Interventional

Summary: 
      The overall design of the study is to perform both a PET and MRI scan on objectively
      identified borderline personality disorder patients, to treat them with olanzapine for 8
      weeks, and to then re-scan the patients with PET.
    

Detailed description: 
      The primary objective of this proposed study will be to compare the baseline PET scan to the
      endpoint scan in 15 BPD patients who have been treated with olanzapine. The comparison of the
      scans will be done through a statistical image analysis, using a pixel-by-pixel group mean
      subtraction strategy with appropriate correction for multiple comparisons. In an exploratory
      fashion we will compare frontal and temporal regions of interest to address hypotheses of
      which areas of the brain might show changes with olanzapine treatment.

      A secondary objective is to use a normal database to compare the baseline PET scan of the 15
      patients in a medication free state to normal subjects. The advantage of this strategy is the
      ability to closely match subjects by gender and age. As noted earlier, Dr. Pardo has data on
      35 control subjects studied on the same scanner we plan to use for this study.
    

Intervention name(s): olanzapine
Intervention type(s): Drug
Intervention description(s): Olanzapine 2.5mg by mouth at bedtime x2 weeks, then Olanzapine 5mg by mouth at bedtime x2 weeks, then Olanzapine 7.5mg by mouth at bedtime x4 weeks.
Other intervention name(s): Zyprexa
Intervention MeSH terms: Olanzapine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Borderline Personality Disorder; BPD; PET; olanzapine; brain
TAB08 in Patients With Psoriasis Vulgaris, Not Adequately Controlled With Current Treatment
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Study to assess Pharmacodynamics, Safety, Pharmacokinetics and clinical effects of TAB08
      during 12 weeks of treatment in patients with Psoriasis Vulgaris, not adequately controlled
      with current therapy.
    

Detailed description: 
      1. To assess dynamics of the T-lymphocytes subpopulations in patients peripheral blood
           during 12 weeks of TAB08 treatment.

        2. To assess dynamics of selected cytokines levels in patients peripheral blood during 12
           weeks of TAB08 treatment.

        3. To assess TAB08 concentrations in patients blood during 12 weeks of TAB08 treatment.

        4. To assess frequency, seriousness and severity of adverse events during 12 weeks of TAB08
           treatment.

        5. To assess changes in PASI, IGA and DLQI during 12 weeks of TAB08 treatment and
           subsequent 4 weeks follow-up.
    

Intervention name(s): TAB08; Placebo
Intervention type(s): Drug; Other
Intervention description(s): The TAB08 will be administered intravenously, by infusion.; The Placebo to TAB08 will be administered intravenously, by infusion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Assessment of the Glycemic Responses to Nutritional Products
Condition: Glycemic Response
Study type: Interventional

Summary: 
      This study assesses the glycemic responses to nutritional products. During a study visit
      fasted subjects will consume one serving of the reference product or the test product.
      Capillary blood samples will be taken at baseline and at several time-points over a 2-hr
      period. Several nutritional products will be tested over time.
    


Intervention name(s): First Reference product (dextrose, containing 25 g of carbohydrates); Second Reference product (dextrose, containing 25 g of carbohydrates); Third Reference product (dextrose, containing 25 g of carbohydrates); High protein tube feed; High-protein tube feed with additional amino acid; Oral Nutritional Supplement for diabetes patients; Oral Nutritional Supplement for diabetes patients (new formula); ONS for disease related malnutrition; Plantbased ONS for disease related malnutrition
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Reference dextrose solution containing 25 g of available carbohydrates; Reference dextrose solution containing 25 g of available carbohydrates; Reference dextrose solution containing 25 g of available carbohydrates; Nutritional product containing 25 g of available carbohydrates; Nutritional product containing 25 g of available carbohydrates; Nutritional product containing 25 g of available carbohydrates; Nutritional product containing 25 g of available carbohydrates; Nutritional product containing 25 g of available carbohydrates; Nutritional product containing 25 g of available carbohydrates
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Glycemic response; Glycemic index; Nutritional products; Healthy individuals