bioihbjkbjnl/mcl2 huggingface dataset:
Secondary Prevention of Depression Applying an Experimental Attentional Bias Modification Procedure
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Depression (Major Depressive Disorder; MDD) has been dubbed "the common cold among the mental
      illnesses" and it is also a highly recurrent disorder. Secondary prevention has been
      identified as a key goal in the long-term management of depression. High recurrence rate
      suggests that there are specific vulnerability factors that increase people's risk for
      developing repeated episodes of the disorder. Preventive strategies should identify and
      ameliorate these factors to reduce the individual's risk of subsequent episodes. Biased
      attention for emotional stimuli is central to the cognitive model where increased sensitivity
      to negative cues is believed to fuel the negative thoughts and feelings in depression and
      play a key role in maintaining the illness. Selective biases in attention can be modified by
      a simple computerized technique; The Attention Bias Modification Task (ABM). This project
      aims to investigate whether ABM can reduce surrogate and clinical markers of relapse in a
      large group highly vulnerable to depressive episodes. The effects of ABM, immediately after
      the two weeks intervention, on three key risk factors for depression will be studied:
      Residual symptoms, cortisol awakening response and emotion regulation strategies. The
      participants will be followed up after 1 month, 6 months and 12 months. The hypothesis that
      ABM will reduce subsequent episodes of low mood over the following 12 months in this group in
      a manner predicted by early changes in these risk factors will be investigated. It will also
      be tested if such effects in the lab may be dependent on candidate genes which affect
      serotonin reuptake and which have been implicated in malleability and emotional learning.
      Effects on underlying neural correlates of emotion regulation will be studied in an fMRI
      experiment in a sub-sample and which will also be stratified by serotonin transporter
      genotype (see also NCT02931487). The predictive value of meta cognitions related to
      rumination and the possible mediating effects of automatic thoughts and perceived stress will
      also be investigated in a sub group (see also NCT02648165).

      The characterization of the cognitive, genetic and neural mechanisms underlying the ABM
      effect will have key implications for future treatment development and combination with other
      treatment modalities like pharmacotherapy.
    


Intervention name(s): Attention Bias Modification; Sham Attention Bias Modification
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Computer based Attention Bias Modification; Computer based Sham Attention Bias Modification
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
The Momba Mobile Application-based Community
Condition: Mental Health Wellness 1
Study type: Interventional

Summary: 
      The investigators' mobile application-based community, termed Momba, will provide a
      bi-directional flow of information on maternal and infant mental health to traditionally
      underrepresented groups of mothers and their infants. The overall goal of this mobile
      application-based community of low-income postpartum women and infants is to increase the
      social support, social networks, and social capital of low-income mothers; thereby, leading
      to a positive change in the health behaviors, utilization of health services, and mental
      health status of both mothers and their infants.
    


Intervention name(s): MOMBA web-based application
Intervention type(s): Behavioral
Intervention description(s): Web-based, interactive, social network application.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Depression; Stress; Social support; Social capital; Maternal
Creatine Augmentation for Adolescent Females With Treatment-Resistant Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary hypothesis is that compared to placebo, 10g of daily creatine monohydrate for
      eight weeks will be associated with significant increases in frontal lobe phosphocreatine and
      beta-nucleoside triphosphate (β-NTP) concentrations. A secondary hypothesis is that decreased
      depressive symptoms measured with the Children's Depression Rating Scale-Revised (CDRS-R) and
      Montgomery-Asberg Depression Rating Scale (MADRS) will be reciprocally correlated with
      increased β-NTP concentrations.
    

Detailed description: 
      The current protocol seeks to expand upon the investigators previous work by opening
      recruitment on a pilot study of creatine 10g daily vs. placebo as a treatment for female
      adolescents with SSRI-resistant MDD. The purpose of the pilot study is twofold: A) to
      evaluate several aspects of the feasibility of creatine supplementation as a treatment for
      this population; and B) to estimate the effect size of adjunctive creatine, to inform the
      design and implementation of a potential future efficacy trial.
    

Intervention name(s): Creatine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Creatine is a nutritional supplement.; The placebo is an inactive ingredient similar in appearance, weight and density to the active treatment.
Other intervention name(s): Creatine Monohydrate; Placebo Control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Creatine; Brain Chemistry; Magnetic Resonance Spectroscopy; Treatment Resistance; Selective Serotonin Reuptake Inhibitor (SSRI) Resistance
A Study Evaluating 24-Week and 48-Week Telaprevir-Based Regimen in Treatment Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is being conducted to learn more about the safety and effect of telaprevir in
      combination with peginterferon alfa-2a (PEG-IFN) and ribavirin (RBV) in participants with
      hepatitis C who have never been treated for their hepatitis C virus (HCV). The study is
      designed to look at the relative benefits of 24 or 48 weeks of total treatment in people who
      respond quickly to a telaprevir-based treatment.
    


Intervention name(s): telaprevir; ribavirin; peginterferon alfa-2a
Intervention type(s): Drug; Drug; Biological
Intervention description(s): 750 mg every 8 hours (q8h) for 12 weeks; 1000 - 1200 mg/day based on body weight for either 24 or 48 weeks; 180 mcg/week for either 24 or 48 weeks
Other intervention name(s): VX-950; Copegus; Pegasys
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Genotype 1
ID & Testing in Male Partners
Condition: HIV
Study type: Observational

Summary: 
      This pilot study is a sub-study of ATN 067. ATN 067 utilizes a cross-sectional research
      design to recruit Latina and African American young women to undergo HIV screening. The
      primary goal of this proposed pilot study, ATN 084, is to explore the feasibility and
      acceptability of index female recruiters identifying and recruiting their past and present
      male sexual partners to undergo HIV screening and complete a one-time ACASI interview. In
      addition, the study will also include female friendship network members who were enrolled in
      ATN 067 and were diagnosed with HIV. These young women will also be asked to recruit their
      past and present male sex partners to undergo HIV screening.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        This study will include index recruiters and their male sexual partners. The index
        recruiters will be comprised of young women who served as index recruiters in ATN 067 and
        members of their female friendship network members who tested HIV positive based on HIV
        screening and a confirmatory test result that was conducted in ATN 067. All study
        participants will be 18 years of age or older.
      
Keywords: Networks; Index recruiter
A Trial In Diabetic Patients To Assess Effect Of CE-326,597 On Glucose Control And Body Weight
Condition: Weight Management; Treatment Of Obesity
MeSH terms: Body Weight
Study type: Interventional
Phase: Phase 2

Summary: 
      Study of whether the investigational drug CE-326,597 improves glucose control and results in
      body weight loss in patients with type 2 diabetes
    


Intervention name(s): CE-326,597 100 mg QD; CE-326,597 50 mg QD; CE-326,597 25 mg QD; Placebo; CE-326,597 5mg QD
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Administered orally, once daily with morning meal for duration of trial (84 days).; Administered orally, once daily with morning meal for duration of trial (84 days).; Administered orally, once daily with morning meal for duration of trial (84 days).; Placebo to match CE-326,597 tablets to be administered orally, once daily with morning meal for duration of trial (84 days).; Administered orally, once daily with morning meal for duration of trial (84 days).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Phase 2A, safety and efficacy trial with CE-326,597 in patients with T2DM.
Metabolomics of Insomnia-Related Hyperarousal
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Observational

Summary: 
      Individuals with insomnia have been shown to have higher overall metabolic rates compared to
      good sleepers, but it is not known which metabolic processes are involved. The goal of this
      study is to compare a wide array of metabolic processes in 15 people with insomnia and 15
      good sleepers. We hypothesize that there will be distinct metabolic processes that are
      functioning differently in those with insomnia.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Individuals with primary insomnia (n=15) and matched good sleepers (n=15)
Shoe Inserts for Treating Osteoarthritis of the Knee
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial will test shoe inserts for the treatment of knee osteoarthritis, the most common
      form of knee arthritis. Those with disease on the inner (medial) aspect of the knee will be
      studied.
    


Intervention name(s): Shoe Insert
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Biomechanics
Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children (RAMSES)
Condition: Peanut Allergy
MeSH terms: Peanut Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, randomized, double-blind, placebo-controlled safety study of AR101
      using the characterized oral desensitization immunotherapy (CODIT™) regimen in
      peanut-allergic children.
    

Detailed description: 
      The primary objective is to assess the safety and tolerability of AR101 when used in a CODIT™
      regimen for approximately 6 months in peanut-allergic children children aged 4 to 17 years,
      inclusive.
    

Intervention name(s): AR101; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): AR101 powder provided in capsules; Placebo powder provided in capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2:1 randomization to AR101 or placebo
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: AR101; Characterized Peanut Allergen; CPNA (Characterized Peanut Allergen); OIT (oral immunotherapy); Peanut Allergy; Peanut-Allergic Children; Desensitization; ARC007; Characterized Oral Desensitization Immunotherapy (CODIT™)
MEDI9447(Oleclumab) Pancreatic Chemotherapy Combination Study.
Condition: Carcinoma; Metastatic Pancreatic Adenocarcinoma
MeSH terms: Adenocarcinoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objective of this study is to evaluate the safety, tolerability, and antitumor activity
      of oleclumab (MEDI9447) in combination with or without durvalumab plus chemotherapy in
      participants with metastatic pancreatic cancer.
    

Detailed description: 
      This is a Phase 1b/2, multicenter, open-label, dose-escalation, and dose-expansion study to
      assess the safety, preliminary antitumor activity, immunogenicity, and pharmacokinetics (PK)
      of oleclumab with or without durvalumab in combination with chemotherapy administered in
      participants with metastatic pancreatic ductal adenocarcinoma (PDAC). Participants with
      previously untreated metastatic PDAC (first-line [1L] metastatic PDAC) will be enrolled in
      Cohort A. Participants with metastatic PDAC previously treated with gemcitabine-based
      chemotherapy (without exposure to 5-fluorouracil [5-FU], capecitabine, or oxaliplatin;
      second-line [2L] metastatic PDAC) will be enrolled in Cohort B. The study consists of 2
      parts, dose escalation (Part 1) and dose expansion (Part 2).
    

Intervention name(s): Oleclumab; Durvalumab; Gemcitabine; Nab-paclitaxel; Oxaliplatin; Folinic acid; 5-FU
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive IV infusion of oleclumab as stated in arm description.; Participants will receive IV infusion of durvalumab as stated in arm description.; Participants will receive IV infusion of gemcitabine as stated in arm description.; Participants will receive IV infusion of nab-paclitaxel as stated in arm description.; Participants will receive IV infusion of oxaliplatin as stated in arm description.; Participants will receive IV infusion of folinic acid as stated in arm description.; Participants will receive IV infusion of 5-FU as stated in arm description.
Other intervention name(s): MEDI9447; MEDI4736; Modified FOLFOX (oxaliplatin, folinic acid, and 5-FU); Modified FOLFOX (oxaliplatin, folinic acid, and 5-FU); Modified FOLFOX (oxaliplatin, folinic acid, and 5-FU)
Intervention MeSH terms: Leucovorin; Folic Acid; Gemcitabine; Oxaliplatin; Fluorouracil; Durvalumab; Levoleucovorin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MEDI9447; oleclumab; immunotherapy; pancreatic cancer; durvalumab
Lymphoma and T Helper 2 Cytokines Relationship With Prognostic Markers
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Observational

Summary: 
      The investigators hypothesized that Non Hodgkin lymphoma is using T helper 2 pathways. So
      that the investigators decided to study of cytokines related to T helper 2 pathways. It is
      well known that parasites and allergic situations also use T helper 2 pathways. Because that
      the investigators excluded the patients have parasites and allergic situations. All the
      patients were over 18. The investigators included the patients with non Hodgkin lymphoma
      which new diagnosed. It is observational study. The investigators took blood before
      chemotherapy and four months later. The investigators did not interfere with which
      chemotherapy will be given to patients. This decision was belong to hematologist or
      oncologist who will treat the patient.
    


Sampling method: Non-Probability Sample
Study population: 
        31 newly diagnosed non hodgkin lymphoma and 27 healthy controls. We studied IL-10 and IL-4
        in lymphoma group and healthy group and observed patients till end of study. We analised
        survival. We compared with IL-4 and IL-10 levels with prognostic factors.
      
Biospecimen description: 
      periperal blood sample
    
Keywords: Survey, interleukin status
Safety and Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Efficacy of Repeat Doses of GSK2982772 in Subjects With Moderate to Severe Rheumatoid Arthritis (RA)
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is the first study with GSK2982772, a receptor-interacting protein-1 (RIP1) kinase
      inhibitor, in subjects with moderate to severe RA who are currently being treated with
      disease modifying anti-rheumatic drugs (DMARDs). The primary objective of the study is to
      investigate the safety and tolerability of repeat oral doses of GSK2982772 in subjects with
      moderate to severe RA. In addition to the PK, a number of experimental and clinical endpoints
      will be employed to obtain information on the PD, and preliminary efficacy in subjects with
      active RA. Although no formal hypothesis will be tested, these endpoints will enable a
      broader understanding of the mechanism of action and potential for clinical efficacy of
      GSK2982772 in RA. After a screening period of up to 30 days, approximately 24 subjects will
      be randomized to receive either GSK2982772 or placebo for 84 days (12 weeks), followed by a
      follow-up period (28 days). The total duration of participation in the study will be
      approximately 20 weeks from screening to the last study visit.
    


Intervention name(s): GSK2982772 60 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK2982772 is available as a 30 mg white to almost white, round film coated tablet which will be administered as two tablets thrice daily as directed.; Placebo is available as a white to almost white, round film coated tablet which will be administered as two tablets thrice daily as directed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: efficacy; safety; pharmacokinetics; pharmacodynamics; Rheumatoid Arthritis; autoimmune
Assessment of Long Term Treatment With Testosterone Undecanoate in Males With Hypogonadism
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the preparation of testosterone undecanoate under conditions which
      resemble real-life situations.
    

Detailed description: 
      The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
      renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor
      of the trial.
    

Intervention name(s): Testosterone undecanoate (TU) - NebidoTM
Intervention type(s): Drug
Intervention description(s): Drug treatment with 14 injections of one ampoule of Nebido (1000 mg of testosterone undecanoate) at individually adjusted injection intervals
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keravive by Hydrafacial for Scalp Health and Enhanced Hair Quality
Condition: Androgenic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional

Summary: 
      The study aims to assess the efficacy and safety of Keravive by Hydrafacial treatments and
      Keravive Peptide Spray for scalp health and enhancing hair quality in patients with
      androgenic alopecia. This study is intended to be a single arm study. Suitable subjects who
      meet all inclusion criteria and consented will undergo 3 in-office Keravive by Hydrafacial
      treatments at Day 0 and Weeks 4 and 8 in combination with daily application on Keravive
      Peptide Spray at home.

      Subjects will be assessed at Day 0, and Weeks 4, 8, and 20 by investigators using the Norwood
      Scale (males), Ludwig Classification (females), and a series of Likert scales for ranking
      improvement in scalp health and hair quality.
    

Detailed description: 
      This study is intended to be a single arm study. Suitable subjects who meet all inclusion
      criteria and consented will undergo 3 in-office Keravive by Hydrafacial treatments at
      baseline and Weeks 4 and 8 in combination with daily application on Keravive Peptide Spray at
      home.

      Subjects will be assessed at baseline, and Weeks 4, 8, and 20 by investigators using the
      Norwood Scale (males), Ludwig Classification (females), and a series of Likert scales for
      ranking improvement in scalp health and hair quality.

      Efficacy will be assessed through a series of dynamic and static questionnaires.
      Investigators will complete static questionnaires at Day 0 and Weeks 4, 8 and 20 rating the
      subjects' hair appearance, thinning, and temporal line recession using Likert scales.
      Subjects will complete dynamic questionnaires at Weeks 4, 8 and 20 to compare their current
      state to their baseline condition for scalp symptoms (itchiness, dryness, and flakiness) and
      hair quality (overall health, fullness, evenness, pigment, hair growth, and hair loss) using
      Likert scales. Subjects will also rank their hair appearance at Day 0, Week 4, 8, and 20.
      Photography will be performed at each study visit. Safety assessments will include
      investigator- and subject-reported adverse events (AEs) during the study.
    

Intervention name(s): Keravive by Hydrafacial Treatments
Intervention type(s): Device
Intervention description(s): Scalp hydradermabrasion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care