bioihbjkbjnl/mcl2 huggingface dataset:
Neurogenic Inflammation in Diabetes
Condition: Diabetes Mellitus; Polyneuropathies; Arthropathy, Neurogenic
MeSH terms: Arthropathy, Neurogenic; Polyneuropathies; Neurogenic Inflammation; Inflammation
Study type: Interventional

Summary: 
      Polyneuropathy is a complication of diabetes mellitus which leads to decreased sensation in
      arms and legs. This in turn can lead to the development of (infected) foot ulcers. Charcot's
      disease can also be a consequence of polyneuropathy. Patients with Charcot's disease suddenly
      develop a red, warm and swollen foot, like an infection. Charcot's disease leads to foot
      fractures. After these fractures have healed, the shape of the foot can be dramatically
      altered. This altered shape of the foot increases the risk of developing foot ulcers. Nerves
      are important in regulating the inflammatory response. This study aims to investigate whether
      the inflammatory response is different in patients with polyneuropathy with and without a
      history of Charcot's disease.
    


Intervention name(s): Intracutaneous injection of Candida albicans antigen.; Temperature measurement.
Intervention type(s): Other; Other
Intervention description(s): Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.; Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Improving College Students' Mental Help-Seeking Intention During the COVID-19 Pandemic
Condition: Help-Seeking Behavior; Mental Health Issue
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      This study aimed at testing the effectiveness of a longitudinal intervention in increasing
      college students' intention to seek mental help during the pandemic.
    

Detailed description: 
      This study aimed at testing the effectiveness of a longitudinal intervention in increasing
      college students' intention to seek mental help during the pandemic.

      A four-armed randomized controlled experiment was conducted to compare two self-persuasion
      methods against two control conditions. Assessments took place at baseline (T0), post-first
      treatment (T1), post-second treatment (six weeks, T2), and ten-week follow-up (T3).

      The results showed that the intervention significantly increased students' help-seeking
      intention, attitude, and efficacy at different time points. It also reduced mental
      help-seeking-related stigma after the first task.
    

Intervention name(s): Mental help-seeking self-persuasion
Intervention type(s): Behavioral
Intervention description(s): Employing a longitudinal design, this study used a self-persuasion framework in a 4-arm intervention to increase college students' help-seeking intentions during the COVID-19 pandemic.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Mental help-seeking; COVID-19; College students; Self-persuasion
A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Granisetron Hydrochloride 1 mg Tablets Under Fasting Conditions
Condition: Nausea; Vomiting
MeSH terms: Nausea; Vomiting
Study type: Interventional

Summary: 
      The objective of this study was to assess bioequivalence of a potential generic 1 mg
      granisetron tablet formulation compared with Roche Laboratories' 1 mg granisetron tablet,
      Kytril, following a single 1 mg dose, under fasting conditions.
    


Intervention name(s): Granisetron
Intervention type(s): Drug
Intervention MeSH terms: Granisetron
Allocation: Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prevention of nausea and vomiting associated with radiation or chemotherapy
Effects of Herbal Products on Metabolism and Hunger
Condition: Obesity; Metabolism
Study type: Interventional

Summary: 
      to test safety and efficacy on metabolism, heart rate, blood pressure, TSH (and other
      blood)and hunger/caloric compensation on ephedra versus placebo
    


Intervention name(s): DietPro; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Clinical and Neuromechanical Predictors for the Evolution of Chronic Non-specific Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      The purpose of the present study is to determine the association between factors known to be
      associated with the development of chronic low back pain (psychological and biological) and
      the evolution of functional disability in individuals with a history of low back pain. To do
      so, 100 individuals with a history of nonspecific low back pain will be followed over a
      period of 18 months. During this time frame, participants will be evaluated three times in
      the laboratory (initial, at 6 months and at 18 months) to determine pain and tolerance
      thresholds, pain inhibition processes as well as neuromuscular activation. Moreover, these
      participants will be assessed every three months (initial, 3, 6, 9 12, 15 and 18 months) for
      functional disability and pain intensity levels of their low back pain as well as for
      psychological symptoms usually associated with the development of chronic low back pain. It
      is hypothesized that high psychological symptoms measured initially will be associated with
      high functional disability throughout the study .
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals with a history of nonspecific low back pain
      
Keywords: psychological factors; functional disability; pain thresholds; tolerance thresholds; motor adaptations; natural course
Bioavailability of 3 Sildenafil Oral Disintegrating Tablet Formulations Compared to the Standard Oral Tablet
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The bioavailability of the oral disintegrating tablet formulations given without water will
      be similar to an equivalent dose of the standard oral tablet given with water.
    


Intervention name(s): Viagra 50 mg tablet; Formulation B ODT tablet 50 mg; Formulation C ODT tablet 50 mg; Formulation D ODT tablet 50 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Commercial tablet, 50 mg, single dose administered with water; Oral disintegrating tablet (ODT), 50 mg, single dose administered without water; ODT, 50 mg, single dose administered without water; ODT, 50 mg, single dose, administered without water
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bioavailability Pharmacokinetic Formulation
Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of XEN901
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The XEN901 Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study
      that will evaluate the safety, tolerability and pharmacokinetics (PK) of both single
      ascending doses (SAD) and multiple ascending doses (MAD) of XEN901 in healthy subjects. It is
      estimated there will be approximately 64 subjects in the planned SAD and MAD cohorts.
    


Intervention name(s): XEN901; Inert Ingredients Oral Product
Intervention type(s): Drug; Drug
Intervention description(s): Capsule filled with XEN901; Placebo capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Pharmacokinetics/Pharmacodynamics (PK/PD) of Multiple Oral Doses of GLPG0555 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety and tolerability of multiple ascending
      oral doses (MAD) of GLPG0555 given to healthy subjects for 13 days compared to placebo, and
      to evaluate the relative bioavailability and pharmacokinetics (PK) of two different aqueous
      suspensions of GLPG0555 administered for 3 days. Finally, it is aimed to characterize PK and
      pharmacodynamics (PD) of GLPG0555 after multiple oral administrations.
    


Intervention name(s): GLPG0555; GLPG0555 aqueous; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): two different aqueous formulations; multiple dose, aqueous formulation, 13 days, 100 mg/day once daily, maximum dose to be determined; multiple dose, aqueous formulation, 13 days days, matching ascending dose schedule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Safety; Tolerability; Pharmacokinetics
Reduction of Asthma Exacerbation Rate in Children by Non-invasive Monitoring of Inflammatory Markers in Exhaled Breath (Condensate): the RASTER Study
Condition: Asthma; Children; Home Monitoring; Exhaled Breath Condensate; Non-invasive Inflammatory Markers; Volatile Organic Compounds
MeSH terms: Asthma
Study type: Observational

Summary: 
      The purpose of the present proposal was to investigate the predictive properties of markers
      in exhaled breath to predict an asthma exacerbation. In addition, the reliability of home
      monitor assessments to measure asthma control will be examined.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This study is carried out in two hospitals in the Netherlands (Maastricht University
        Medical Centre, Maastricht; and Orbis Medical Centre, Sittard).
      
Keywords: asthma; children; home monitoring; exhaled breath condensate; non-invasive inflammatory markers; volatile organic compounds
The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin on Glycaemic Control in Subjects With Type 2 Diabetes Mellitus
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Europe and North America. The aim of this trial is to compare the
      effect on blood sugar control of liraglutide or sitagliptin, both in combination with
      metformin, in subjects with type 2 diabetes inadequately controlled with metformin alone.

      The trial has been extended by 52 weeks. The extension will consist of two 26-week periods:

        1. Week 27-52 after randomisation

           - All subjects will continue receiving sitagliptin or liraglutide at unchanged dose and
           dosing regimen.

        2. Week 53-78 after randomisation

             -  Subjects receiving sitagliptin at the end of week 52 after randomisation will
                discontinue sitagliptin and will be randomised 1:1 to liraglutide 1.2 mg/day or
                liraglutide 1.8 mg/day. Liraglutide will be initiated at a dose of 0.6 mg/day, and
                increased to 1.2 mg/day or 1.8 mg/day in weekly intervals.

             -  Subjects receiving liraglutide 1.2 mg/day or 1.8 mg/day at the end of week 52 after
                randomisation will continue the treatment at unchanged dose and dosing regimen.
                Trial completion is planned for June 2010.
    


Intervention name(s): liraglutide; sitagliptin; metformin; liraglutide
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1.2 mg once daily, subcutaneous (under the skin) injection; Tablets, 100 mg daily; Tablets, minimum 1500 mg daily; 1.8 mg once daily, subcutaneous (under the skin) injection
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Exercise Tolerance and Cardiac Output in Patients With Heart Failure After Intervention of Rehabilitation Program
Condition: Heart Failure With or Without CRT-P/D
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      Home-based rehabilitation programs have not been widely few been studied and the training
      effects are not unclear. This study evaluates the beneﬁcial effects of home-based cardiac
      rehabilitation on quality of medical care in patients with chronic heart failure.
    

Detailed description: 
      cardiopulmonary rehabilitation programs are safe and effective for improving functional
      capacity, quality of life, as well as for reducing in the re-admission rate and all-cause
      mortality of patients with heart failure.clinical trials that have established the benefits
      of hospital-based cardiac rehabilitation for patients with chronic heart failure. Home-based
      cardiac rehabilitation could be more accessible and acceptable compared with hospital-based
      cardiac rehabilitation.
    

Intervention name(s): Home-based cardiac rehabilitation
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Home-based cardiac rehabilitation; Quality of Medical Care; Heart Failure
Evaluation of Absorption, Metabolism, and Excretion and Estimation of the Absolute Bioavailability of K-312
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to Evaluation of absorption, metabolism, and excretion of
      [14C]-K-312 and estimation of the absolute bioavailability of K-312 in healthy male subjects
    


Intervention name(s): K-312 100 mg; K-312 100 ug C14 IV
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose; microtracer dose containing ≤37 kBq (1000 nCi) [14C] given as a 5-ml IV push over 2 minutes
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study of Arzoxifene to Treat Korean Women With Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is for Korean women who are postmenopausal and also suffer from osteoporosis.

      The study will test if women who are given 20 mg of arzoxifene once a day for six months have
      a less severe level of osteoporosis than those women who do not take arzoxifene.

      All patients will receive 500 mg of elemental calcium and 400 to 600 IU Vitamin D daily
      starting 4 weeks prior to study drug administration continuing through the 6 months of
      therapy.
    


Intervention name(s): arzoxifene; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg, QD, PO,24 weeks; QD, PO, 24 weeks
Other intervention name(s): LY353381
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Mirena Efficiency and Tolerability During the First Year of Use
Condition: Medicated Intrauterine Devices; Contraception
Study type: Interventional
Phase: Phase 4

Summary: 
      In this trial the efficacy and safety of Mirena was investigated during the first year of use
    


Intervention name(s): Mirena (BAY86-5028)
Intervention type(s): Drug
Intervention description(s): Intrauterine levonorgestrel containing device (market product)
Intervention MeSH terms: Levonorgestrel
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mirena; Levonorgestrel; Intrauterine device; Efficacy; Tolerability; First year of use
Plan A Birth Control: Randomized Controlled Trial of a Mobile Health Application for Contraception Information
Condition: Mobile Applications; Contraception; Contraception Behavior
Study type: Interventional

Summary: 
      The primary objective of the investigators study was to design a comprehensive and medically
      accurate contraception counseling mobile health application and evaluate the effects of this
      contraception counseling application on the contraceptive methods that patients selected and
      their knowledge of that method.
    


Intervention name(s): Mobile Health Application; Health Educator Counseling
Intervention type(s): Other; Other
Intervention description(s): Mobile Health application for contraception information; Counseling via health educator
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Study Evaluating Serum Collected From Healthy Adults For Development of Pneumococcal Opsonophagocytic Assay
Condition: Healthy
Study type: Interventional

Summary: 
      The study will identify healthy adults who have been vaccinated against pneumococcus, and
      collect blood for the purpose of developing laboratory assays.
    

Detailed description: 
      Collect serum with antibody levels capable of killing pneumococcal bacteria from healthy
      prevaccinated adults to develop OPA assays for the 13 serotypes in 13-valent pneumococcal
      conjugate vaccine.
    

Intervention name(s): Large volume blood draw
Intervention type(s): Procedure
Intervention description(s): Large volume blood draw
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Keywords: Vaccines; Pneumococcal Conjugate Vaccine; Adult
Clinical Study to Evaluate Antibody and Cell Mediated Immunity of A/H1N1 Influenza Vaccine in Healthy Subjects
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is explore the antibody and cell mediated immune responses to one
      injection of Focetria™ pandemic influenza vaccine in healthy adults aged 18-60 years.
    

Detailed description: 
      This will be a Phase IV open-label clinical profiling study. The population to be enrolled
      will consist of healthy adults aged 18-60 years. A total of approximately 60 subjects are
      planned for enrolment into this study.

      Subjects enrolled in this study will receive 7.5 µg of vaccine + MF59 (9.75 mg/dose). Each
      subject will receive one 0.5 mL IM dose (deltoid muscle, non-dominant arm) of H1N1sw vaccine
      at Visit 1, after the blood draw. Up to 70 mL of blood will be drawn for CMI and antibody
      assessment from all subjects at all study visits.

      Subjects will be requested to declare occurrence of influenza-related symptoms during the
      study period. Whenever appropriate, subjects might be asked to provide throat swab for viral
      typing. Subjects with laboratory confirmed H1N1sw influenza might be asked to provide one
      blood sample (70 mL) within 4 weeks after influenza resolution.

      Although this study is not designed nor powered to draw conclusions regarding safety and
      tolerability, all subjects will be followed, but not analyzed, for safety throughout the
      study. After vaccination, all subjects will remain under medical supervision at the study
      site for 30 minutes to be monitored and evaluated for possible immediate hypersensitivity
      reactions. All study subjects will be instructed on the completion of diary cards to record
      local and systemic reactions for seven days, starting on the day of vaccination and
      continuing during the 6 following days. The same diary cards will additionally be used to
      collect any vaccine-related reactions and any changes in the subject's health (including any
      serious medical problems such as hospitalizations or any life-threatening medical problems)
      and any medications taken by the subject throughout the study. All serious adverse events and
      all adverse events will be recorded throughout the entire trial.
    

Intervention name(s): egg-derived A/H1N1 pandemic influenza vaccine
Intervention type(s): Biological
Intervention description(s): One 0.50 mL IM dose injection (7.5 µg of vaccine + 9.75 mg MF59)
Other intervention name(s): Focetria™
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Influenza; Vaccines; A/H1N1; Influenza Vaccines
Dermacyd PH_DETINLYN (Lactic Acid) Sweet Flower - Photo Evaluation.
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate the absence of photoirritation and photosensitization potential of the product
      Dermacyd PHDETINLYN Sweet Flower.
    


Intervention name(s): Dermacyd PH_DETINLYN (Lactic Acid)
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Validation of DigiCog and Konectom Tools to Support Digitalized Clinical Assessment in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The primary objective of this study is to establish scores of Cognitive impairment (CI) of
      the 3 DigiCog [Brief Computerized Cognitive Assessment for Multiple Sclerosis (BCCAMS) app]
      tests [Computerized Speed Cognitive Test (CSCT), Computerized Episodic Visual Memory Test
      (CEVMT) and the French Learning Test (FLT), a verbal memory test similar to the CVLT], using
      a tablet application in a sample of healthy participants matched to persons with MS (PwMS).

      The secondary objectives of this study are to determine the ability of the DigiCog app to
      detect cognitive impairment (CI) compared to the classical Brief International Cognitive
      Assessment for MS (BICAMS) in PwMS; to determine the relationship between depressive symptoms
      and cognitive performance in Multiple Sclerosis (MS) sample; to determine the relationship
      between subjective perception of CI and cognitive performance ; to evaluate the reliability
      of Konectom™ digital outcome assessments (DOAs) in healthy subjects (HS) and PwMS; to
      evaluate the convergent validity of Konectom™ digital outcome assessments (DOAs) against
      in-clinic conventional disability outcome assessments in PwMS; to evaluate differences in
      Konectom™ DOAs [self administered at home and in-clinic] between PwMS and HS; to evaluate the
      variability of Konectom™ DOAs self-administered at home in free-living environment in HS and
      PwMS; to compare Konectom™ DOAs between in-clinic supervised administration versus
      self-assessments in free-living environment in HS and PwMS; to evaluate the clinical
      meaningfulness of Konectom™ DOAs against Patient-Reported Outcomes (PRO) in PwMS.
    


Intervention name(s): DigiCog (BCCAMS app); Konectom Application
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Administered as specified in the treatment arm.; Administered as specified in the treatment arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dosing Validation Study of Oral Testosterone Undecanoate (TU, LPCN 1021).
Condition: Hypogonadism, Male
MeSH terms: Hypogonadism; Eunuchism
Study type: Interventional
Phase: Phase 3

Summary: 
      Multicenter, open-label, one treatment study evaluating the efficacy of LPCN 1021 in adult
      hypogonadal male subjects.
    


Intervention name(s): LPCN 1021
Intervention type(s): Drug
Intervention description(s): Oral testosterone undecanoate
Intervention MeSH terms: Methyltestosterone; Testosterone 17 beta-cypionate; Testosterone; Testosterone undecanoate; Testosterone enanthate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment