bioihbjkbjnl/mcl2 huggingface dataset:
TC-6987 for the Treatment of Mild to Moderate Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to determine whether TC-6987 improves respiratory function in subjects
      with asthma by reducing airway hyper-responsiveness and inflammation.
    

Detailed description: 
      Asthma is a common, chronic inflammatory disorder of the airways that affects an estimated 20
      to 22 million people in the United States. It is characterized by variable and recurring
      symptoms, notably airflow obstruction, bronchial hyperresponsiveness, and an underlying
      inflammation. The bronchospasm is caused by inflammation of the muscles surrounding the air
      passageways, making them smaller, thus more difficult for air to freely move in and out of
      the lungs. Cardinal symptoms of asthma include coughing, chest tightness, shortness of breath
      and wheezing. These symptoms are often more severe in the morning and late night, and usually
      reversible with medications. Clinically, asthma is typically classified according to the
      frequency of symptoms, forced expiratory volume in 1 second (FEV1), and peak expiratory flow
      rate.

      The rationale for this Phase II proof of concept study is to demonstrate that TC-6987
      improves respiratory function in subjects with asthma, compared to placebo, as measured by
      the Baseline FEV1 on Day 1 compared to the End-of-Treatment FEV1 on Day 28 or Early
      Withdrawal (EW); and also to assess the safety and tolerability profile of TC-6987 in
      subjects with asthma.
    

Intervention name(s): TC-6987; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TC-6987 50 mg capsule given once daily on Days 1 to 28; Matching placebo capsule given once daily on Days 1 to 28
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Asthma; Mild to Moderate Asthma
Training Study to Characterise Biomarkers to the Engerix B Vaccine
Condition: Healthy
Study type: Interventional

Summary: 
      It is thought that vaccines trigger innate inflammatory responses to induce antigenspecific
      adaptive immunity (the desired effect), but excessive inflammation may lead to serious
      inflammatory complications or unwanted side effects. Currently there is a lack of reliable
      biomarkers (a measurable biological response that predicts something) able to predict severe
      inflammation and this has resulted in the development of several vaccines being terminated
      and the withdrawal of some licensed vaccines which were associated with inflammatory
      complications.

      This study is part of the BIOVACSAFE project which is a 5year €30M project funded by the
      Innovative Medicine Initiative. The project involves a series of clinical studies using
      licensed vaccines as benchmarks to generate clinical data on inflammation and identify
      biomarkers that can be used to predict acceptable reactogenicity. The target is to identify
      biomarkers that can predict the occurrence of beneficial and detrimental effects in response
      to a vaccine. Such biomarkers could be used in future vaccine development programs to
      optimize selection of vaccine candidates with a profile that will be unlikely to generate
      worrisome safety signals once they are in generalized use.

      This study is one in a series of "training" studies which will each use different licensed
      vaccines that are prototypical representatives of a class of vaccine used in a particular
      target population. Twenty four subjects will be randomised into two groups to receive: A)
      Engerix B vaccine (n = 20), B) Saline placebo (n = 4). Following a screening visit,
      participants will undergo two immunisations at month 0 and month 6. Each immunisation will
      occur during a seven day residential visit which will include immunization and intensive
      monitoring of physiological (e.g. heart rate, oral temperature, blood pressure) metabolic and
      immune (innate and adaptive) parameters. Both residential visits will be followed up by four
      outpatient visits with further monitoring and blood samples.
    


Intervention name(s): Engerix B Vaccine; Placebo
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Volunteers; Identify; Biomarkers; Vaccine Safety
Scapular Dyskinesis: a Reliability and Validity Study of Comprehensive Classification Test
Condition: Unilateral Shoulder Pain With and Without Scapular Dyskinesis
MeSH terms: Shoulder Pain; Dyskinesias
Study type: Observational

Summary: 
      Study Design: Clinical measurement (cross-sectional)

      Objectives: The purpose of this study was to investigate the reliability and validity of the
      novel scapular dyskinesis classification test.

      Background: A visual-based clinical assessment with sufficient reliability and validity to
      identify scapular dyskinesis provides information for rehabilitation treatment.

      Methods: A visual-based palpation method was evaluated by two independent physiotherapists in
      60 subjects with unilateral shoulder pain to test reliability. This method classified the
      scapular movements during arm raising/lowing movements in scapular plane as single abnormal
      scapular patterns (inferior angle/ medial border/ superior border of scapula prominence and
      abnormal scapulohumeral rhythm) or mixed abnormal scapular patterns. Different patterns of
      scapular dyskinesis were also validated by corresponding alternation of the scapular
      kinematics and muscular activities assessed by electromagnetic motion-capturing system and
      surface electromyography (EMG).
    

Detailed description: 
      No other detailed description
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Sixty subjects (36 males and 14 females, age: 22.5 ± 2.6) were recruited.Potential
        participants from outpatient clinic in a University hospital and local internet media were
        evaluated and recruited. They read and signed the informed consent approved by the Hospital
        institutional review boards.
      
Keywords: scapular dyskinesis, kinematics, muscular activities
measurINg forceS durInG cHiropractic Treatment
Condition: Low Back Pain
MeSH terms: Low Back Pain
Study type: Interventional

Summary: 
      The INSIGHT pilot study will measure forces applied by a doctor of chiropractic (DC) during
      the delivery of a specific, manually based chiropractic treatment for participants with low
      back pain.
    

Detailed description: 
      Low back pain (LBP) is a well-recognized health problem. One common manual therapy available
      for the treatment of LBP is spinal manipulation (SM), which can be separated into 2
      categories: High-Velocity Low-Amplitude (thrust) and Low-Velocity (non-thrust) SM according
      to their force-delivery profiles. One commonly utilized non-thrust SM technique is the
      Flexion-Distraction procedure. Several studies have reported manually applied forces during
      thrust SM; however, the forces used during non-thrust SM, specifically those used with
      Flexion-Distraction treatment are still unknown. The results of this pilot study will provide
      preliminary information on treatment forces and sample size justification for future
      full-scale trials, while also ascertaining the feasibility of the study protocol and patient
      recruitment methods for such trials.
    

Intervention name(s): Flexion-Distraction (non-thrust) spinal manipulation
Intervention type(s): Other
Intervention description(s): Enrolled participants will receive chiropractic care over a 2-week period. Chiropractic care includes standard therapies for back pain. A doctor of chiropractic determines the therapeutic approach and treatment frequency based upon a participant's clinical presentation. If provided, treatments will include low-velocity (non-thrust) spinal manipulation using the Flexion-Distraction procedure. Recommendations for exercise, lifestyle modifications, or other therapies may also be provided.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Endotoxin Challenge Study For Healthy Men and Women
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The proposed study will examine the effect of pre-treatment with inhaled GSK256066 using a
      lung inflammation model induced by bronchoscopic instillation of bacterial endotoxin
      (lipopolysaccharide, LPS) in healthy volunteers.Data from this study will be used to support
      GSK256066 dose selection for future studies in COPD patients.
    


Intervention name(s): GSK256066; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK256066 will be available as dry powder inhaler with dosing strengths of 12.5, 37.5, 50 micrograms per inhalation.; Subjects will receive placebo inhaler.
Intervention MeSH terms: 6-((3-((dimethylamino)carbonyl)phenyl)sulfonyl)-8-methyl-4-((3-methyloxyphenyl)amino)-3-quinolinecarboxamide
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Diagnostic
Keywords: LPS challenge,; Healthy volunteers
Safety of Intradermal Versus Intramuscular Administration of HIV Lipopeptides in HIV Uninfected Adult Volunteers
Condition: HIV Infections; HIV Seronegativity
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Intramuscular (IM) administration of HIV lipopeptide vaccines have been shown to be able to
      induce HIV-1-specific T cell-mediated immune responses. The objective of this trial was to
      evaluate the safety and immunogenicity of LIPO-4 vaccine (HIV lipopeptides including 4
      peptides from Gag, Pol, RT and Nef HIV-1 proteins, each peptide linked to TT) intradermally
      (ID) compared to IM administration.
    

Detailed description: 
      Dose-sparing strategies that use intradermal (ID) delivery of vaccines may be one approach
      for improving a vaccines immunogenicity and reducing the cost of vaccines.

      In this study, 68 HIV-negative healthy adult volunteers, 21-55 years old, all belonging to
      the "Volunteers for a Vaccine" network set up by ANRS, were randomized to receive at weeks 0,
      4, and 12, either 3 IM doses of 0.5 ml of LIPO-4 containing 500 µg of each peptide (n= 35
      volunteers), or 3 ID doses of 0.1 ml, containing 100 µg of each peptide (n=33 volunteers).
      Total follow-up was 48 weeks. Safety was assessed clinically and by laboratory tests.
      Participants were given diary cards to record adverse events. HIV-1 immune responses were
      assessed by ELISPOT and lymphoproliferative assay at weeks 0, 2, 6, 14, 24, and 48
    

Intervention name(s): Lipopeptides LIPO-4
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV Vaccines; HIV Seronegativity
The Efficacy of Hyperemesis Gravidarum on Macular Thickness, Corneal Thickness and Intraocular Pressure in Pregnancy
Condition: Corneal Dystrophy; Macular Dystrophy; Hyperemesis Gravidarum - Severe
MeSH terms: Corneal Dystrophies, Hereditary; Macular Degeneration; Hyperemesis Gravidarum
Study type: Interventional

Summary: 
      Aim

      Physiological changes in intraocular pressure as well as in the cornea and macula may occur
      during pregnancy.

      In the literature, there are limited data on ocular findings in hyperemesis gravidarum.
      Therefore, we have decided to investigate the effect of hyperemesis gravidarum on macular
      thickness, corneal thickness and intraocular pressure (IOP).
    

Detailed description: 
      A total of 110 people, 55 of whom were diagnosed with hyperemesis gravidarum and 55 of whom
      were in the control group, were included in the study. The inclusion criteria for the study
      were as follows: First trimester (8-14 weeks of gestation) pregnancy with positive fetal
      heartbeat and no history of systemic disease; no continuous use of medication; diagnosis of
      hyperemesis gravidarum (ketonuria and weight > 3 kg or 5% of the body) and the occurrence of
      less than three vomiting attacks per day with loss of weight; body mass index (BMI) within
      normal limits; being between the ages of 18 and 40; not drinking alcohol or smoking. A total
      of 94 patients, 40 of whom were diagnosed with hyperemesis gravidarum and 54 healthy pregnant
      women, were divided into two groups by recording their age, BMI, laboratory and eye findings.
    

Intervention name(s): Optic coherence tomography
Intervention type(s): Diagnostic Test
Intervention description(s): Every participant was subjected to a comprehensive ophthalmologic examination which included measuring auto-refraction (average of three values, Topcon Autorefractometer model KM 8900, Japan), uncorrected visual acuity with cycloplegic refraction (with 0.5% cyclopentolate HCl), and IOP in millimeters of mercury (mmHg, Goldmann applanation tonometer). Moreover, slit-lamp biomicroscopy (HaagStreit, Bern, Switzerland) was performed, concentrating on potential corneal scarring and/or lenticular opacities.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 groups ( group 1 hyperemesis gravidarum ) (group 2 control group)
Masking: Single (Participant)
Primary purpose: Health Services Research
Study of the Pharmacodynamics, Pharmacokinetics, Safety, and Immunogenicity of Single Escalating Doses of BCD-180 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to investigate the pharmacodynamics, pharmacokinetics, safety, and
      immunogenicity of BCD-180 after a single intravenous administration in escalating doses to
      healthy volunteers.
    

Detailed description: 
      The study will be carried out in 2 stages. Stage 1 involves administration of escalating
      doses of study drug (BCD-180) in 7 cohorts of healthy subjects. The first cohort will include
      one subject ("sentinel volunteer"). Each of the subsequent cohorts will include 3 subjects,
      each of whom will receive a preset cohort dose of BCD-180 as a single intravenous infusion.
      Stage 2: additionally two cohorts of healthy Asian volunteers (Cohorts 8 and 9) will be
      included: subjects will receive a single infusion of BCD-180 at selected doses (planned for
      further clinical development) based on the results of the main period of Stage 1.
    

Intervention name(s): BCD-180, dose 1; BCD-180, dose 2; BCD-180, dose 3; BCD-180, dose 4; BCD-180, dose 5; BCD-180, dose 6; BCD-180, dose 7
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): anti-TRBV9 monoclonal antibody single infusion at dose 1; anti-TRBV9 monoclonal antibody, single infusion at dose 2; anti-TRBV9 monoclonal antibody, single infusion at dose 3; anti-TRBV9 monoclonal antibody, single infusion at dose 4; anti-TRBV9 monoclonal antibody, single infusion at dose 5; anti-TRBV9 monoclonal antibody, single infusion at dose 6; anti-TRBV9 monoclonal antibody, single infusion at dose 7
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Stage 1. The first cohort will include one subject ("sentinel volunteer") who will receive BCD-180 at a dose 1. Starting from the 2nd cohort, the study will have a classic "3 + 3" design.
Subjects will be monitored for 14 days following drug administration to assess the presence of dose limiting toxicity (DLT). In the absence of DLT, another cohort with a higher dose level will be formed.
After all subjects have completed the main study period (Days 1-57), the safe dose range of BCD-180 will be determined based on assessed PD, PK, safety and immunogenicity endpoints.
Further follow-up of the subjects included in stage 1 will continue up to a year.
Stage 2. Two cohorts of healthy Asian volunteers (Cohorts 8 and 9) will be included. Subjects will receive a single infusion of BCD-180 at selected doses planned for further clinical development based on the results of the main period of stage 1.
Masking: None (Open Label)
Primary purpose: Other
Type 2 Diabetes Mellitus With Obesity and Dyslipidemia Treated by Chinese Herbal Medicine
Condition: Type 2 Diabetes Mellitus in Obese; Dyslipidemia Associated With Type II Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Obesity; Diabetes Mellitus, Type 2; Dyslipidemias
Study type: Observational

Summary: 
      This study is a retrospective review of participants who visited Department of Endocrinology,
      Guang'anmen Hospital and accepted traditional Chinese medicine formula for at least sis
      months, from January 2015 to December 2020. All the participants should be diagnosed as type
      2 diabetes mellitus, obesity and dyslipidemia. Therapeutic effect of traditional Chinese
      medicine will be evaluated based on the changes of blood glucose, body mass index, blood
      lipids, and blood pressure.
    

Detailed description: 
      The diagnostic criteria for type 2 diabetes mellitus and obesity are based on the Guideline
      for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition). The
      diagnostic criteria of dyslipidaemia are based on the Chinese Guidelines on Prevention and
      Treatment of Dyslipidaemia in Adults (2016, revision edition).
    

Intervention name(s): Chinese herb medicine
Intervention type(s): Drug
Intervention description(s): Patients took 200 ml Chinese herb decoction twice a day before breakfast and dinner.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who visited Department of Endocrinology, Guang'anmen Hospital, from January 2015
        to December 2020.
      
Keywords: type 2 diabetes mellitus; dyslipidemias; obesity; Chinese herbal medicine; retrospective review
Investigating Memory in Healthy Subjects Using Transcranial Direct Current Stimulation
Condition: Healthy Adults
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether we can improve associative memory
      performance in healthy subjects, by applying transcranial Direct Current Stimulation (tDCS)
      during a verbal paired-associate learning task
    

Detailed description: 
      Associative memory refers to remembering the association between two items, such as a face
      and a name or a word in English and the same word in another language. It is not only
      important for learning, but it is also one of the first aspects of memory performance that is
      impacted by aging and by Alzheimer's disease. For decades, neuroscientists have investigated
      associative learning and memory and ways to accelerate and enhance associative learning and
      memory.

      Transcranial Direct Current stimulation (tDCS) is a non-invasive and painless electrical
      stimulation technique that has demonstrated to accelerate learning and improve memory in some
      studies. To investigate whether it is possible to improve associative memory using tDCS, the
      performance in a Verbal Paired-Associate memory task of 4 groups targeting different areas
      will be compared.
    

Intervention name(s): tDCS
Intervention type(s): Device
Intervention description(s): tDCS
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly assigned to one of four groups: (1) tDCS targeting location 1 paired with memory task (2) tDCS targeting location 2 with memory task (3) tDCS targeting location 3 paired with memory task (4) tDCS targeting location 4 paired with memory task
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: transcranial Direct Current Stimulation (tDCS); memory
Therapeutic Effects of Neurofeedback in Anorexia Nervosa
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether neurofeedback training can significantly
      reduce the symptoms of anorexia nervosa (AN) with focus on changes in personality and
      psychological well-being. The primary aims of this study include:

        1. To examine whether AN patients are able to control their alpha-activity through
           neurofeedback.

        2. To examine the effects of neurofeedback on symptomatology and personality variables in
           AN patients.

        3. To examine the long-term effects of neurofeedback in the treatment of AN.
    

Detailed description: 
      The aim of the present study is to investigate the impact of EEG frequency band biofeedback
      (neurofeedback) training on EEG topography and symptomatology of patients suffering from
      anorexia nervosa (AN).

      There is evidence that alpha-neurofeedback leads to an increase in positive therapy outcome
      in clinical populations by changing long-lasting EEG frequency patterns. The use of an
      EEG-guided relaxation paradigm has been shown to be associated with well-being and
      improvements in pathology of psychiatric patients.

      In the present study the effects of alpha-training on EEG activity, mood, personality,
      well-being, blood parameters, and heart frequency will be evaluated in a sample of anorectic
      girls (12-18 years).

      The subjects are trained with at least 10 sessions alpha-neurofeedback, in order to enhance
      individual alpha frequency, with spectral resting EEG, EKG, blood samples, ERP-measures and
      psychometric measures assessed before and after training. Neurofeedback is conducted over a
      period of five weeks, with each participant receiving two training sessions per-week.
      Neurofeedback is administered using USBAmp-EEG system.

      For better surveillance of training effects there are two non-treatment control groups. A
      patient group receiving conventional therapy programme of the Psychosomatic Division of the
      Pediatric Department at the University Hospital Graz and a healthy control group.

      A twelve-week follow-up study is carried out in order to document long-term effects of
      alpha-neurofeedback training in AN patients.
    

Intervention name(s): neurofeedback training
Intervention type(s): Behavioral
Intervention description(s): training of individual alpha frequency, 10 sessions, each 15 min
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neurofeedback, alpha, anorexia nervosa