bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetic and Tolerability Study of 14 mg Single Dose of Teriflunomide in Subjects With Severe Renal Impairment
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      - To determine the effect of severe renal impairment on the pharmacokinetic profile of
      teriflunomide administered as a single 14 mg dose as compared to healthy subjects

      Secondary Objective:

      - To assess the tolerability of teriflunomide administered as a single 14 mg dose in subjects
      with severe renal impairment compared to subjects with normal renal function.
    

Detailed description: 
      The total study duration per subject is 11-15 weeks broken down as follows:

        -  Screening: up to 3 weeks

        -  Hospitalization: 3 days (admission 1 day prior to study drug intake)

        -  Follow-up: 10 -12 weeks
    

Intervention name(s): Teriflunomide HMR1726; Cholestyramine
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form:film coated tablet
Route of administration: oral administration on Day 1 under fasted condition; Pharmaceutical form:powder
Route of administration: oral administration 3 times per day on Day 54 and 55
Intervention MeSH terms: Teriflunomide; Cholestyramine Resin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Preliminarily Evaluate the Efficacy of Domperidone in Adult Chinese Participants With Functional Dyspepsia
Condition: Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose of the study is to assess the efficacy of domperidone in treatment of
      functional dyspepsia (FD) in Chinese participants and identify sub-populations (subtype of
      the disease) who are sensitive to domperidone treatment.
    


Intervention name(s): Domperidone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive domperidone tablets orally.; Participants will receive matching placebo to domperidone tablets orally.
Other intervention name(s): JNJ-17296812
Intervention MeSH terms: Domperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Comparision of Pharmacokinetic and Pharmacodynamic of Biocon Insulin N and Humulin® N
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      Single-centre, randomised, double-blind, three-period, six-sequence, partially replicated
      design, crossover trial in healthy subjects
    

Detailed description: 
      The present study is designed to demonstrate pharmacokinetic and pharmacodynamic equivalence
      of Biocon Insulin N with Humulin® N in healthy subjects.

      The treatment consists of one single dose of the test or reference product, administered
      during each of the three study periods, separated by 5-7 days between each dosing. The
      planned trial duration for each subject is about 17 to 43 days. Eligible subjects will
      undergo three euglycaemic clamp examinations (each of 24 hours duration).

      Depending on the sequence in which a particular subject is randomized, each subject will
      either undergo two clamps with administration of test product plus one clamp with
      administration of reference product, or, two clamps with administration of reference product
      plus one clamp with administration of test product, in random order.
    

Intervention name(s): Biocon Insulin N; Humulin® N
Intervention type(s): Biological; Biological
Intervention description(s): Biocon Insulin N is an intermediate-acting isophane suspension of human insulin produced by recombinant deoxyribonucleic acid(rDNA) technology utilizing Pichia pastoris (yeast).; Humulin® N (human insulin [recombinant deoxyribonucleic acid origin] isophane suspension) is an intermediate-acting human isophane insulin. Humulin® N is a suspension of crystals produced from combining human insulin and protamine sulphate.
Intervention MeSH terms: Isophane Insulin, Human
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Partially replicated design, crossover trial
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Recombinant Human Insulin N (rhi N)
Evaluation of the 755nm Alexandrite for the Treatment of Epidermal and Dermal Pigmented Lesions
Condition: Dermal and Epidermal Pigmented Lesions
Study type: Interventional

Summary: 
      The purpose of this study is to assess treatment for facial dermal and epidermal pigmented
      lesions using the 755nm Alexandrite laser.
    


Intervention name(s): 755nm Alexandrite Laser
Intervention type(s): Device
Intervention description(s): 755nm Alexandrite Laser for epidermal and dermal pigmented lesions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
The Anti-fungal Effect of Miconazol Versus Miconazol-Loaded Chitosan Nanoparticles
Condition: Oral Thrush
MeSH terms: Candidiasis, Oral
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective: this study aimed to evaluate the therapeutic effects of topical application of
      miconazole and miconazole-loaded chitosan nanoparticles in treatment diabetic patients with
      oral candidiasis.
    

Detailed description: 
      Abstract:

      Objective: this study aimed to evaluate the therapeutic effects of topical application of
      miconazole and miconazole-loaded chitosan nanoparticles in treatment diabetic patients with
      oral candidiasis.

      Subjective and methods:

      In this randomized controlled clinical trial,. A total of 80 diabetic patients presenting
      with symptomatic oral candidiasis were randomly assigned into two treatment groups:
      miconazole and miconazole-loaded chitosan nanoparticles. The patients were treated for a
      duration 28days , and clinical assessments were conducted at baseline, 7, 14, 21 and 28 days.

      Microbiological analysis was performed to determine the Candida species and assess their
      susceptibility to the antifungal agents. Clinical parameters, including signs and symptoms of
      oral candidiasis, were also evaluated.

      .
    

Intervention name(s): Chitosan
Intervention type(s): Drug
Intervention description(s): chitosan loaded with miconazole nanoparticles gel
Other intervention name(s): miconaz oral gel
Intervention MeSH terms: Chitosan
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 1:1 parallel arms
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diabetic patients or oral candidiasis or oral thrush
Pharmacological Intervention in Insulin Resistance Targeting Autonomic Nerve Activity
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The present study on pharmacological intervention in autonomic nervous
      dysregulation(parasympathetic dysfunction,) regarding insulin resistance, is a concept
      testing in humans tohelp identify potential new pharmacological target sites in the central
      nervous system.
    


Intervention name(s): Atropine; Physostigmine; Placebo Sodium
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10 ug/kg bolus, 4 ug/kg/h infusion; 0,12ug/kg/min
Intervention MeSH terms: Atropine; Physostigmine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Clamp
A Prospective Clinical Trial to Evaluate the Efficacy and Safety of Neurotropic B-Vitamins in Clinically Diagnosed Peripheral Sensory Polyneuropathy of Different Etiologies.
Condition: Peripheral Sensory Neuropathy of Different Etiologies
MeSH terms: Polyneuropathies
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to investigate the efficacy of the Test Product in subjects with
      clinically diagnosed peripheral sensory polyneuropathy of different etiologies compared to
      placebo.
    

Detailed description: 
      This prospective, multi-center, randomized, double-blind, placebo-controlled, parallel-group
      Phase III clinical study is designed to investigate the efficacy and safety of the Test
      product versus placebo in male and non-pregnant female subjects with clinically diagnosed
      peripheral sensory polyneuropathy of different etiologies aged 18 to 70 years.

      The study will be conducted in 17 sites in Mexico. 318 patients with clinically diagnosed
      symptoms of peripheral sensory polyneuropathy of different etiologies who fulfill the
      inclusion and exclusion criteria will be enrolled and randomized in a 1:1 ratio to receive
      either oral vitamin B combination daily or matching placebo for 120 days.

      The primary and secondary outcome measures will be evaluated at each post-Screening visit.
      Exploratory outcomes, and safety/tolerability/treatment satisfaction assessments will be
      evaluated as per schedule of activities.

      Approvals were obtained from Local Ethics Committees and from Mexican Regulatory Authority
      (COFEPRIS).
    

Intervention name(s): Vitamin B combination tablet; Placebo Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Once daily, with some liquid with or after a meal; Once daily, with some liquid with or after a meal
Intervention MeSH terms: Vitamins; Vitamin B Complex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
12-week Safety Evaluation of Oral CS-0777 in Multiple Sclerosis Patients
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 12-week study to assess the safety, tolerability, pharmacokinetics and
      pharmacodynamics of oral CS-0777 in patients with Multiple Sclerosis.
    


Intervention name(s): CS-0777 tablets; CS-0777 tablets; CS-0777 tablets
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.1 mg, once-weekly, for 12 weeks; 0.3 mg, once-weekly or once every 2 weeks, for 12 weeks; 0.6 mg, once-weekly or once every 2 weeks, for 12 weeks
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple sclerosis, relapsing, secondary progressive, clinically isolated syndrome, MRI
Fasting Bioequivalence Study of 2 Progesterone Soft Capsules 200 mg in 66 Healthy Female Subjects Under Vaginal Route
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was designed to assess the bioequivalence of Progesterone 200 mg Soft Capsule (JSC
      "Farmak", Ukraine) versus Utrogestan® 200 mg Soft Capsule (Manufacturer: Cyndea Pharma, S.L.,
      Spain, MAH: Laboratoires Besins International, France) after a single Vaginal dose in healthy
      female subjects under fasting conditions.
    

Detailed description: 
      An open-label, randomized, single dose, two-treatment, four-period, two-sequence, fully
      replicated crossover bioequivalence study with a washout period of 7 days in healthy female
      subjects under fasting conditions.Mode of administration:Intravaginally, the capsule
      introduced deeply into the vagina while lying down.During each period 25 blood samples were
      drawn 5 mL at (-1.00,-0.50,-0.137), before dosing and at 0.50, 1.00, 1.50, 2.00,2.50, 3.00,
      3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 9.00, 10.00, 12.00, 16.00, 24.00,36.00,
      48.00, and 72.00 hours after dosing.
    

Intervention name(s): Progesterone 200 mg Soft Capsule (JSC "Farmak", Ukraine); Utrogestan® 200 mg Soft Capsule (Manufacturer: Cyndea Pharma, S.L., Spain, MAH: Laboratoires Besins International, France)
Intervention type(s): Drug; Drug
Intervention description(s): Each dose was administered Intravaginally, the capsule introduced deeply into the vagina while lying down, after at least 10 hrs of fasting, under the direct supervision of the Principal and/ or clinical Investigator; Each dose was administered Intravaginally, the capsule introduced deeply into the vagina while lying down, after at least 10 hrs of fasting, under the direct supervision of the Principal and/ or clinical Investigator
Other intervention name(s): Injesta; Utrogestan®
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: bioequivalence; pharmacokinetics; generic drugs; Progesterone; Soft Capsule
Real World Data on Management of Male LUTS
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Observational

Summary: 
      This study will describe the current medical care given to men who discuss their lower
      urinary tract symptoms with a HCP. It will document the primary reasons for the visit, the
      baseline characteristics of these men, the treatment received, and the practice patterns of
      specifically a primary care physician managing these patients.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        men
Drug-drug-interaction Study of Candesartan, Amlodipine and Atorvastatin
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to determine the potential pharmacokinetic interaction of candesartan cilexetil,
      atorvastatin as atorvastatin calcium trihydrate and amlodipine as amlodipine besilate at
      steady state after a multiple oral administration and to monitor the safety of the
      co-administration of these drugs. This study aims to determine if the steady state study
      pharmacokinetic parameters of any of the given drugs and the tolerability is altered when
      administered concomitantly.
    

Detailed description: 
      This study was an open-label, comparative, multiple-dose, fixed sequence steady state trial
      to compare the pharmacokinetic of candesartan cilexetil, atorvastatin as atorvastatin calcium
      trihydrate, amlodipine as amlodipine besilate given as a multiple dose under fasting
      conditions in the absence and presence of each other.

      Bioanalysis of candesartan, atorvastatin and amlodipine is performed by LC/MS/MS method.
    

Intervention name(s): Candesartan, Amlodipine, Atorvastatin
Intervention type(s): Drug
Intervention description(s): compare the pharmacokinetic of candesartan cilexetil, atorvastatin as atorvastatin calcium trihydrate, amlodipine as amlodipine besilate from reference products given as a multiple dose
Intervention MeSH terms: Amlodipine; Candesartan; Candesartan cilexetil; Atorvastatin
Intervention model: Single Group Assignment
Intervention model description: Subjects are to be admitted the night before dose no. 1 administration, confining at clinical site until the 24 hours post dose no. 5 administration. 4-days off interval between last dose of treatment A and first dose of treatment B allowed. Subjects to be admitted the night before dose no. 6 administration, confining at clinical site until the 24 hours post dose no. 10 administration. 4-days off interval between last dose of treatment B and first dose of treatment C allowed. Subjects to be admitted the night before dose no. 11 administration, confining at clinical site until the 24 hours post dose no. 26 administration.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Candesartan; Amlodipine; Atorvastatin; drug interaction; multiple-dose; pharmacokinetic
Evaluating the Efficacy of Ragweed-SPIRE Following Exposure to Ragweed Allergen in an Environmental Exposure Chamber
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether Ragweed-SPIRE is safe and effective at
      reducing allergy symptoms in people who suffer from allergy to Ragweed pollen
    


Intervention name(s): Ragweed-SPIRE; Placebo
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rhinoconjunctivitis; Rhinitis; Seasonal; Ragweed; Allergy
Characterization of the Variability Of Insulin Secretory Parameters in the Meal Tolerance and the Maximal Stimulation Tests of Subjects With Prediabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2; Prediabetic State; Glucose Intolerance
Study type: Observational

Summary: 
      A multi-year clinical study to improve tools for measuring the function of insulin-producing
      beta cells in people with type 2 diabetes mellitus.
    

Detailed description: 
      A three-year observational study to standardize the meal tolerance and maximum stimulational
      tests for measuring beta cell function in the clinical setting. It also aims to improve
      methods for the early prediction of the long-term response to an intervention and for
      identification of patients at risk for rapid beta cell function deterioration, thereby
      enabling future clinical studies that examine diabetes progression.
    

Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        obese individuals with prediabetes
      
Keywords: type 2 diabetes; beta cell function; meal tolerance test; maximum stimulation test; method standardization; insulin secretion; prediabetes; insulin sensitivity
First in Human Study to Compare Safety Between Intravenous Bolus Versus Infusion of ApTOLL
Condition: Stroke
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of the study is to assess the tolerability and safety of ApTOLL
      administration when comparing intravenous infusion vs. bolus intravenous injection, in
      healthy volunteers. Pharmacokinetic profile of ApTOLL will be also analysed as secondary
      objective of the study.
    


Intervention name(s): ApTOLL
Intervention type(s): Drug
Intervention description(s): ApTOLL will be administered as follows:
Day 1: a dose of 0.1mg/kg will be administered intravenously as a slow infusion.
Day 2: a dose of 0.1mg/kg will be administered intravenously as single bolus injection.
Day 3: a dose of 0.2mg/kg will be administered intravenously as single bolus injection.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
First-In-Human Study of BBT-401-1S Following Single and Multiple Ascending Doses in Healthy Volunteers
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical trial is the first-in-human study of BBT-401-1S. The purpose of this phase 1
      study is to assess the safety and tolerability of single and multiple ascending oral doses of
      BBT-401-1S in healthy adult subjects.
    


Intervention name(s): BBT-401-1S, Single dose; BBT-401-1S, Multiple doses; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose of BBT-401-1S, 7 dose levels, oral capsule; Multiple doses of BBT-401-1S, 7 days, 3 dose levels, oral capsule; Placebo matched to BBT-401-1S, oral capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pellino-1
NEAT - Prevention and Treatment of Overweight and Obesity.
Condition: Overweight; Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      This study will investigate the effect on Non-exercise Activity Thermogenesis (NEAT) when
      implementing active workstation at offices compared to conventional office work. The primary
      hypothesis is that this implementation will lead to a significant increase in time spent
      walking per day.
    

Detailed description: 
      NEAT consists of the energy expenditure of the physical activities that are non sporting-like
      and that we perform in our everyday life, such as walking, cleaning, shoveling snow etc.
      Which occupation we have play a big role in how much we are able to active our NEAT during
      our days and those who have more active jobs can expend up to 1500kcal more per day than
      those with sedentary jobs.

      This study aims to try and increase NEAT at offices where sedentary time often is high.
      Participants will be randomized to either an intervention group or to a control group.
      Participants in the control group will continue to work at their regular desk, but will
      receive an individual health talk in the beginning of the study where diet and physical
      activity recommendations will be discussed.Participants in the intervention group will
      receive the same individual health talk and a treadmill desk, which they will use for 12
      months at self-selected speed. They will be recommended to walk on the treadmill for at least
      1 hour per day.
    

Intervention name(s): Treadmill workstation; Health talk
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention group will receive a treadmill workstation for 12 months. They will use this at self-selected speed and will be recommended to use this for at least 1 hour per day. Participants in the control group will continue with conventional office work at their regular desk. Participants in the intervention group will receive four boosting e-mails during the study period, in which they will be encouraged to use the treadmill.; Participants in both groups will receive a health talk with recommendations about diet and physical activity habits.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: NEAT; Treadmill desk
Neural Mechanism of Cortisol Awakening Response Suppression Effect on Human High-order and Social Cognitions
Condition: Healthy
Study type: Interventional

Summary: 
      CAR is short for cortisol awakening response. The neural mechanism of CAR effect on
      high-order cognition and social cognition is less known...
    


Intervention name(s): Dexamethasone; Vitamin C
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Cortisol Awakening Response suppression; Dexamethasone Suppression Test; high-order cognition; social cognition
Computer-Assisted, Game-Based Cognitive Training on Attention
Condition: Young Adults; Attention
Study type: Interventional

Summary: 
      The aim of this study was to investigate the effect of 8 weeks of cognitive training on
      attention function in healthy young people.
    


Intervention name(s): Computer assited, game-based cognitive training
Intervention type(s): Other
Intervention description(s): After recording the demographic information of the participants, the Stroop Test was applied to evaluate attention. After the stages of the test were explained to the participants in detail, they were shown once in practice.
The training group received 20 minutes of cognitive training every day for 8 weeks. No training was applied to the control group. Groups were evaluated at baseline and after 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cognitive-training