bioihbjkbjnl/mcl2 huggingface dataset:
Walking or High Intensity Exercise for Anxiety
Condition: Generalized Anxiety Disorder; Panic Disorder; Social Anxiety
MeSH terms: Anxiety Disorders; Panic Disorder
Study type: Interventional

Summary: 
      After an initial phone screen process, approximately 50 participants will be enrolled and
      evaluated/screened in person after consenting to achieve 30 eligible participants with a
      principal diagnosis of GAD, panic disorder, or social anxiety disorder and high anxiety
      sensitivity (Anxiety Sensitivity Index score =20). Participants will be given a choice of
      either high intensity interval training (HIIT) or walking interventions, which will be
      completed over the course of 8 weeks. The goal of the study is to 1) obtain pilot data
      comparing the efficacy of HIIT vs. walking for effects on psychiatric, functioning and immune
      outcomes, 2) to identify adherence levels given the choice of exercise intensity, and 3) to
      identify proportion of individuals opting for each intervention. Results from this pilot
      study will be used to inform future grant applications including a K award.
    


Intervention name(s): Low Intensity Exercise Intervention; High Intensity Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Those in the walking intervention will be instructed to take walks below a brisk pace (low intensity) to improve mood; Instructed in high intensity interval training techniques and will be provided videos to follow for implementation of intervention at home that will include short bursts of high energy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Efficacy and Safety of HIP2101 in Patients With Acute or Chronic Gastritis
Condition: Gastritis
MeSH terms: Gastritis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the safety and clinical efficacy of HIP2101 in
      patients with acute or chronic gastritis.
    


Intervention name(s): HIP2101; RLD2101; HPP2101; HPP2102
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Test drug; Reference drug; Placebo drug; Placebo drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of Injection HB0017 in Adult Healthy Volunteers
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      placebo by subcutaneous (SC) administration. Forty subjects (10 subjects per cohort for SC
      administration) will be randomized and assigned to up to 4 sequential doses cohorts of HB0017
      (50 mg, 150 mg, 300 mg and 450 mg) or matching placebo. Each cohort of ten volunteers will be
      randomly assigned to receive either a single dose of HB0017 or matching placebo at a ratio of
      4:1. Starting with the lowest dose, each of the subsequent doses will be administered only if
      the preceding dose was determined to be safe and well tolerated. The decision to escalate the
      next dose will be made jointly by the sponsor s medical expert and the investigator based
      upon review of 15-day blinded safety data prior to dosing each cohort.
    


Intervention name(s): HB0017; placebo
Intervention type(s): Drug; Drug
Intervention description(s): HB0017 at 100 mg/mL (1 mL/vial) in 2 mL glass vial with a rubber stopper. HB0017 will be administered in the abdominal area by a subcutaneous injection in the mornings. A maximum volume of 1 mL is injected per site.; A matching injection solution containing a specific volume of normal saline (0.9%, Sodium Chloride Injection USP) and no active substance will be prepared for the subjects who will be assigned to placebo according to the dose schedule.
Other intervention name(s): recombinant humanized IgG1 monoclonal antibody; 0.9%, Sodium Chloride Injection USP
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Prebiotics in Patients With Non-alcoholic Liver Disease
Condition: Non-alcoholic Fatty Liver Disease; Metabolic Syndrome
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Metabolic Syndrome
Study type: Interventional

Summary: 
      The purpose of this present study is to evaluating whether prebiotics - ITF (Inulin/OFS
      75/25) is effective in treating patients with non-alcoholic liver disease.
    

Detailed description: 
      The study will include 60 patients with Non-alcoholic fatty liver disease (NAFLD) which will
      randomize to two groups, receiving either ITF (Inulin/oligofructose-OFS 75/25) or
      maltodextrin (placebo).

      The trial will last for 26 weeks: Stage 1-Run-in period: Subjects will be followed to
      ascertain weight maintenance. Stage 2- Randomized intervention period: Subjects will be
      assigned to receive 16 gram/day of ITF or maltodextrin. Both ITF and placebo will be provided
      in identical opaque packages and both subjects and researchers will be blinded to the
      content.

      After signing informed (-2 week) consent, the following data will be collected: demographics,
      lifestyle habits including dietary questionnaires, and medical history. At week 0, week 12
      and week 24 all the following tests will be performed: Vital Signs: blood pressure,
      anthropometric measurements, body composition determined by bioelectrical impedance analysis
      (BIA). Biochemical blood tests: liver function tests fasting glucose insulin & lipid profile,
      CRP (an inflammation marker), SCFA, BCAA, and LBP and FGF 19. Fecal samples: fecal samples
      will be used for microbiota composition analysis, and BA analysis. Assessment of liver status
      At week 0 and 24 by using magnetic resonance spectroscopy (1H-MRS), SteatoTest and NashTest
      (FibroMax™) and by liver enzymes for evaluating steohepatitis.
    

Intervention name(s): ITF (Inulin/OFS 75/25); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participants will consume 16 g/day ITF; Participants will consume 16 g/day maltodextrin
Other intervention name(s): Prebiotics- Inulin, OFS - oligofructose; maltodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Inulin, OFS (oligofructose)
Evaluation of the PK Profile of Firibastat Following Administration of Firibastat Prototype Tablet Formulations
Condition: Healthy Males
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-centre, open-label, non-randomised, period fixed sequence study designed to
      investigate the PK and safety of Firibastat (QGC001) modified release (MR) prototype tablet
      formulations and compare this to a reference Firibastat (QGC001) immediate release (IR)
      capsule formulation in healthy male subjects.

      It is planned to enrol 12 subjects to receive single oral doses of investigational medicinal
      product (IMP).
    

Detailed description: 
      Subjects will be screened for eligibility to participate in the study up to 28 days before
      dosing and for each treatment period they will be admitted to the clinical unit on the
      evening prior to IMP administration (Day -1). On the morning of Day 1, subjects will receive
      IMP in the fasted state (or following a FDA standard high-fat breakfast, if applicable) and
      will remain on site until 48 h post-dose. Between the periods, an interim analysis and review
      of safety and PK data from dosed regimens will be performed in order to determine which
      Firibastat (QGC001) MR prototype tablet formulation and dose to administer in subsequent
      periods. A follow-up phone call will take place 7 to 10 days post-final dose to ensure the
      ongoing wellbeing of the subjects.
    

Intervention name(s): Firibastat
Intervention type(s): Drug
Intervention description(s): Firibastat (QGC001) 500 mg
Other intervention name(s): QGC001
Intervention MeSH terms: Firibastat
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Analyse of Diagnosis Value of Keloid on 68Ga- FAPI-04 PET-CT
Condition: Keloid
MeSH terms: Keloid
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Keloid scars are common benign fibroproliferative reticular dermal lesions. Fibroblasts are
      considered to be the key cellular mediators of fibrogenesis in keloid scars. Thus this
      prospective study is going to investigate whether 68Ga-FAPI PET/CT may provide evidence for
      diagnosis and evaluate the effectiveness of treatment.
    

Detailed description: 
      Keloid scars are common benign fibroproliferative reticular dermal lesions with unknown
      etiology and ill-defined management with a high rate of recurrence post-surgery. The
      progression of keloids is characterized by increased deposition of extracellular matrix
      proteins, invasion of the surrounding healthy skin, and inflammation.

      Fibroblast activation protein alpha (FAP-a) and dipeptidyl peptidase IV(DPPIV) are proteases
      located at the plasma membrane promoting cell invasiveness and tumor growth and have been
      previously associated with keloid scars. Thus this prospective study is going to investigate
      whether 68Ga-FAPI PET/CT may be superior for diagnosis, therapy response assessment, and
      follow-up of keloid.

      This study aims to explore whether FAP plays a role in the mechanisms of scar tissue
      progression, as well as the diagnostic efficacy of these two imaging agents, and to be able
      to evaluate relevant treatments for personalized therapy.
    

Intervention name(s): 68Ga-FAPI
Intervention type(s): Drug
Intervention description(s): Intravenous injection of one dosage of 18.5-22.2MBq (0.5-0.6 mCi)/Kg 68Ga-FAPI. Tracer doses of 68Ga-FAPI will be used to image lesions of keloid by PET/CT.
Other intervention name(s): 68Ga-fibroblast activating protein inhibitors
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Effect of Nicotine on Brain Reward Pathways
Condition: Depressive Disorder
MeSH terms: Depressive Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigators will determine whether an acute dose of nicotine, in the form of the
      nicotine lozenge, impacts brain and behavioral measures of mood and reward responsiveness in
      individuals with major depressive disorder.
    


Intervention name(s): Nicotine polacrilex
Intervention type(s): Drug
Intervention description(s): Single Acute dose
Other intervention name(s): Nicotine lozenge
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Nicotine; Depression
Iron and COVID-19 Vaccine Response
Condition: Iron Deficiency Anemia; Vaccine Response Impaired; COVID-19 Vaccine; Iron Deficiency Anemia Treatment
MeSH terms: COVID-19; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Study type: Interventional

Summary: 
      Vaccines often underperform in Africa compared to high-income countries. Why vaccines do not
      work as well in Africa remains uncertain. Malnutrition likely plays a role. Our study
      objective is to assess whether iron deficiency anaemia in young women impairs their immune
      response to the COVID-19 vaccine, and whether iron treatment improves their response.
    

Detailed description: 
      Group 1 (immediate iron treatment) will receive iron treatment before vaccination. Women in
      both groups will receive the 1st dose of the COVID-19 vaccine. Vaccine response will be
      measured 28 and 56 days after the first vaccine administration in both groups. At 28 days,
      participants will receive the 2nd dose of the COVID-19 vaccine. Group 2 (delayed iron
      treatment) will receive iron treatment at study end.
    

Intervention name(s): Ferinject
Intervention type(s): Dietary Supplement
Intervention description(s): intravenous iron carboxymaltose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study for Evaluating Different Methods of Measuring Depression Treatment Response
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Purpose of the study is to evaluate use of electronic diaries and voice acoustics for use in
      future depression clinical trial. Focus is on increased precision of measurement.
    


Intervention name(s): electronic diary; Sertraline; Placebo; voice acoustics
Intervention type(s): Procedure; Drug; Drug; Procedure
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Food-based Solutions for Optimal Vitamin D Nutrition and Health
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      This project aims at proving the efficacy and safety of food based solutions to prevent
      vitamin D deficiency in high risk populations of Caucasian and South Asian origin living in
      Denmark.
    

Detailed description: 
      The study is a 12 week double-blinded, randomised, placebo-controlled food-based intervention
      trial in a real-life setting. 140 (18-50 y) women in risk of vitamin D deficiency and with
      Caucasian or South Asian origin. The two ethnic groups of women will each be randomised into
      two groups. One receiving vitamin D fortified foods and the other receiving the same kind of
      foods non-fortified. Foods given in the study period are free of charge for the participants
      and will be handed out every second week. The foods are eggs, yoghurt, cheese and crisp
      bread.

      The study includes a baseline visit and a final visit, at both visits blood samples will be
      drawn, anthropometrics, muscle strengths, dietary and background questionnaires.
    

Intervention name(s): Non-fortified foods; Fortified foods
Intervention type(s): Other; Other
Intervention description(s): The non-fortified placebo foods are eggs, cheese, yoghurt and crisp bread (without vitamin D added).; The fortified intervention foods are eggs, cheese, yoghurt and crisp bread (with about 20 mcg/day).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vitamin D; Fortification
Short-course Antimicrobial Therapy for Paediatric Respiratory Infections
Condition: Community-acquired Pneumonia
MeSH terms: Respiratory Tract Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized controlled double-blind non-inferiority clinical trial to determine whether five
      days of high-dose amoxicillin leads to comparable rates of early clinical cure compared with
      10 days of high-dose amoxicillin for previously healthy children with mild community-acquired
      pneumonia.
    


Intervention name(s): Amoxicillin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Experimental arm must receive 5 days placebo after 5 days amoxicillin to preserve blinding.
Other intervention name(s): Amoxil
Intervention MeSH terms: Amoxicillin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: antibiotic stewardship; non-inferiority; randomized controlled trial
A Bioequivalence Study of Pegylated Interferon Alfa-2a (PEG-IFN Alfa-2a) Benzyl Alcohol (BA)-Free Formulation Versus PEG-IFN Alfa-2a (Pegasys) Following Subcutaneous Administration
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, randomized, multi-center, single dose, two-period, two-sequence
      crossover study to investigate the bioequivalence of PEG-IFN alfa-2a BA-free formulation
      versus the reference market formulation (PEG-IFN alfa-2a [Pegasys®]) following subcutaneous
      administration via prefilled syringe in healthy Chinese participants.
    


Intervention name(s): PEG-IFN alfa-2a BA-free formulation (Test); PEG-IFN alfa-2a market formulation (Reference)
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive single injection of 180 micrograms (mcg) of PEG-IFN alfa-2a BA-free formulation, subcutaneously via prefilled syringe in either period 1 and 2 (each period having 35 days).; Participants will receive single injection of 180 mcg of PEG-IFN alfa-2a market formulation, subcutaneously via prefilled syringe in either period 1 and 2 (each period having 35 days).
Other intervention name(s): Pegasys
Intervention MeSH terms: Peginterferon alfa-2a; Interferon-alpha; Interferon alpha-2; Interferon-alfa-1b
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Effects of Pumpkin Seed Oil Supplementation on Cardiovascular Function in Postmenopausal Women.
Condition: Elevated Blood Pressure; Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Postmenopausal women have a higher prevalence of cardiovascular (CV) disease than age-match
      men. Growing evidence from rat studies have demonstrated CV-protective effects of pumpkin
      seed oil (PSO).

      The investigators hypothesis is that PSO would improve CV health in postmenopausal women.
    

Detailed description: 
      The purpose of the study is to examine the effects of 6 weeks of PSO on arterial and
      autonomic function in postmenopausal women. Specific aims of the study are to:

      To investigate the extent to which PSO will improve cardiovascular disease risk factors by
      assessing arterial stiffness, aortic BP and wave reflection, and autonomic function (heart
      rate variability).
    

Intervention name(s): Pumpkin Seed Oil; Placebo
Intervention type(s): Other; Other
Intervention description(s): This intervention consisted of 6 weeks of PSO consumption. Subject were supplemented with 3 g/day of PSO which was ingested in the form of 1g capsules with each main meal of the day (breakfast, lunch and dinner).; This intervention consisted of 6 weeks of placebo consumption. Subject consumed 1 capsule of maltodextrin with each main meal of the day to match the dose and number of capsules ingested daily by the PSO group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Use of Racotumomab in Patients With Pediatric Tumors Expressing N-glycolylated Gangliosides
Condition: Neuroblastoma; Ewing's Sarcoma; Wilm's Tumor; Retinoblastoma; Glioma
MeSH terms: Neuroblastoma; Sarcoma, Ewing; Wilms Tumor; Retinoblastoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be carried out in children with diagnosis of cancer with tumors known to
      express N-glycolylated gangliosides. The disease must be resistant to conventional therapy.
      The acute toxicity and immune response will be evaluated.

      The expression of N-glycolylated gangliosides in tumors has previously been investigated in
      the tumor sample bank at this Hospital. The expression of N-glycolyl GM3 was shown in
      neuroblastoma, Ewing's sarcoma, Wilm's tumor and retinoblastoma.

      Gliomas and the aforementioned tumor types have a very bad prognosis when conventional
      treatment is ineffective.

      New therapeutic strategies have thus been examined, and several immunotherapeutic approaches,
      including dendritic cell vaccines, peptide vaccines and anti-idiotype vaccines are currently
      being assessed.

      Racotumomab is an anti-idiotype antibody capable of inducing anti-N-glycolyl GM3 antibodies
      in patients with melanoma, breast cancer and lung cancer.

      Dose escalation studies have shown the safety of racotumomab in the 0.5 to 2 mg dose range.
      The 1 mg dose level was selected for the ensuing clinical studies.

      This clinical trial in children involves three dose levels: 0.15 mg, 0.25 mg and 0.4 mg,
      owing to the difference in body surface between an adult (1.73 sq. m in average) and the
      candidate population for this study (0.55 to 0.7 sq. m).
    


Intervention name(s): racotumomab
Intervention type(s): Drug
Intervention description(s): Dosage form: intradermal injection. Dosage: 0.15 mg; 0.25 mg; 0.4 mg. Frequency: 3 biweekly injections or 6 biweekly injections. Duration: 4 weeks or 10 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase 1 TP-271 Oral PK Single Ascending Dose Study
Condition: Bacterial Infections
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and tolerability of up to 6 different
      single ascending oral doses of TP-271, ranging from 25 mg to 300 mg, in healthy adult male or
      female subjects.
    

Detailed description: 
      This study is designed to assess oral TP-271, and the objectives of the study are to examine
      the safety, tolerability, and PK of oral TP-271 in healthy adult subjects after
      administration of a single dose. A single-dose, dose-escalating study design is common for
      early clinical studies. A cohort size of 8 subjects (6 receiving oral TP-271 and 2 receiving
      placebo) for the single ascending dose cohorts (Cohorts A through F) will allow sufficient
      data assessments of plasma and urine concentrations, plasma PK parameters, and safety without
      exposing large numbers of subjects to oral TP-271 in this clinical study. One additional
      cohort of 8 subjects will first receive treatment with TP-271 or TP-271 co-administered with
      ethylenediaminetetraacetic acid (EDTA) and then cross-over to treatment with the other study
      agent, which will allow a comparison of the bioavailability of TP-271 alone compared to
      TP-271 co-administered with EDTA, as well as allow additional assessment of plasma and urine
      concentrations, plasma PK parameters, and safety.
    

Intervention name(s): TP-271
Intervention type(s): Drug
Intervention description(s): single oral dose of TP 271 or placebo, randomized 3:1, doses escalating as 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, and 300 mg, and a final crossover cohort of 50 mg TP-271 and 50 mg TP-271 with 250 mg of EDTA, or placebo and 250 mg of EDTA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other