bioihbjkbjnl/mcl2 huggingface dataset:
Investigation on Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of a Long-acting GLP-1 Analogue (Semaglutide) in an Oral Formulation in Healthy Male Subjects
Condition: Diabetes; Diabetes Mellitus, Type 2; Healthy
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of the trial is to investigate the safety,
      tolerability and pharmacokinetics (the effect of the investigated drug on the body) of single
      and multiple doses of a long-acting GLP-1 analogue (semaglutide) in an oral formulation in
      healthy male subjects.
    


Intervention name(s): semaglutide; semaglutide; placebo; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A maximum of six single-dose cohorts of oral semaglutide administered according to an ascending dose design. Starting dose 2 mg, max. dose 60 mg. Progression to next dose will be based on safety evaluation. Sequential cohorts.; Oral semaglutide administered as five multiple dose cohorts, where one of the cohorts will test a different dosing condition compared to the others. End doses from 10 mg/day to 60 mg/day. Progression to next dose will be based on safety evaluation. Semi-parallel cohorts.; In each cohort of 10, eight subjects will randomised to active treatment and two to placebo.; In each cohort of 24, 16 subjects will be randomised to active treatment, four to placebo and four to a enhancer-containing placebo (placebo C).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Standardized sTudy With Almotriptan in eaRly Treatment of Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Observational

Summary: 
      This is a observational, open, prospective, single arm cohort study within authorized SPC
      conditions to describe the effectiveness of Almotriptan in treating acute migraine attacks
      when pain is mild and in the first hour of pain in everyday primary care clinical practice.
    

Detailed description: 
      Primary Objective:

      To describe the effectiveness of Almotriptan in treating acute migraine attacks when pain is
      mild and in the first hour of pain in everyday primary care clinical practice.

      Secondary Objectives:

        1. Influence of an educational intervention on the early intake of the treatment

        2. Influence of medication history or concomitant medication on treatment results

        3. Influence of migraine triggers on treatment results

        4. Influence of stress on treatment results

        5. Tolerability profile validation

        6. Patients' satisfaction

        7. Reasons for delaying migraine treatment intake
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Following SPC conditions and study requirements, male or female of 18 to 65 years old with
        a minimum of one year of migraine history (International Headache Society criteria, see
        criteria attached in the protocol Annex 1) of moderate or severe intensity and with a
        frequency of 2 to 6 attacks per month for the past 3 months.
      
Keywords: Migraine; Early intervention; Primary Care; Almotriptan
Low Dose Naltrexone-buprenorphine Transfer to Vivitrol Injection in Opioid Dependence
Condition: Opiate Dependence
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate a very low dose naltrexone-buprenorphine treatment
      to transfer opioid dependent individuals to extended release naltrexone injection (Vivitrol).
      The hypothesis is that patients will complete the transfer to Vivitrol successfully, finding
      the treatment acceptable and showing minimal withdrawal discomfort.
    

Detailed description: 
      Thirty-five opioid dependent (OD) volunteers seeking treatment will be enrolled in an
      open-label, flexible-dosing, outpatient trial at Duke Addictions Program. On days 1-3,
      participants will receive buprenorphine/naloxone daily at a starting dose of 4mg,
      progressively decreasing to 2 mg on days 2- 3. Participants will also receive very low dose
      naltrexone (VLNTX) at a dose of 0.25 mg to 1mg on Days 1-3, 2 to 6 mg on Day 4 and between 10
      and 50 mg on Days 5-7. Then a VIVITROL injection, 380 mg, will be administered on Day 8.

      Evaluations will occur daily for up to 6 hours until 1 day after VIVITROL injection and then
      weekly for 4 weeks. Patients will receive ancillary medications as needed and weekly
      psychosocial intervention. At the end of the study, participants will be offered outpatient
      treatment of OD at the study site, or will be referred to other treatment programs.
    

Intervention name(s): very low dose naltrexone; extended release naltrexone; buprenorphine/naloxone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): On days 1-3, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 mg, progressively decreasing to 2 mg on Days 2-3 and very low dose naltrexone at 0.25 mg to 1 mg on Days 1-3, 2 to 6 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg.; On days 1-3, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 mg, progressively decreasing to 2 mg on Days 2-3 and very low dose naltrexone at 0.25 mg to 1 mg on Days 1-3, 2 to 6 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg.; On days 1-3, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 mg, progressively decreasing to 2 mg on Days 2-3 and very low dose naltrexone at 0.25 mg to 1 mg on Days 1-3, 2 to 6 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg.
Other intervention name(s): Vivitrol; Suboxone
Intervention MeSH terms: Naltrexone; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Opioid Addiction; Addiction; Drug Dependence
Analgesic Mechanisms of Percutaneous Electrolysis
Condition: Percutaneous Electrolysis; Pain; Analgesia; Pain Modulation; Endogenous Analgesia System
MeSH terms: Agnosia
Study type: Interventional

Summary: 
      Percutaneous electrolysis is based on the application of a galvanic current through an
      acupuncture needle. The underlying mechanisms that explain the efficacy of this technique are
      not completely well understood. The objective is to delve into the neurophysiological
      analgesic effects of percutaneous electrolysis. Participants will be assigned to one of three
      intervention groups. The analgesic effects of the technique will be evaluated by means of
      variables related to endogenous pain modulation.
    


Intervention name(s): Sham intervention; Low intensity percutaneous electrolysis; High intensity percutaneous electrolysis
Intervention type(s): Other; Other; Other
Intervention description(s): The needle will be inserted into the right common extensor tendon of the epicondyle for 90 seconds without galvanic current.; A single impact of galvanic current will be applied in the common extensor tendon of the epicondyle (right side) with an intensity of 0.3 mA for 90 seconds.; Three impacts of galvanic current will be applied in the common extensor tendon of the epicondyle (right side) with an intensity of 3 mA and a duration of 3 seconds each.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Pain Perception: on Relationships Between Dental Anxiety and Olfaction
Condition: Dental Anxiety; Dental Pain; Essential Oil
MeSH terms: Toothache; Anxiety Disorders
Study type: Interventional

Summary: 
      the objective of this study is to evaluate the ability of olfaction in obtaining positive
      emotional and behavioral responses toward dental anxiety and pain in patients undergoing
      different dental procedures.
    

Detailed description: 
      All patients who meet inclusion criteria of the study will be given a written consent and
      enrolled into a randomized double-blinded controlled study (investigator and patients are
      blinded about the study). Patients will be divided into lavender and control groups. Patients
      in lavender group will subjected 2 % lavender vapors. In control group, patients will inhale
      distal water vapors
    

Intervention name(s): Aromatherapy; Placebo
Intervention type(s): Other; Other
Intervention description(s): Lavender will be inhaled through three phases; Vapors of the distal water will be inhaled through three phases
Other intervention name(s): Lavender; Plain distal water
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients will be divided into a control group in which the patients will be subjected to vapors of plain distal water, and lavender group where the patients will inhale vapors of the lavender oil to stimulate olfaction
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dental Anxiety; Dental Pain; Emotional changes; Olfaction; Essential Oil; Lavender
Fetal and Maternal Outcome in Preterm Premature Rupture of Membranes (PPROM)
Condition: Premature Rupture of Membrane
MeSH terms: Premature Birth; Fetal Membranes, Premature Rupture; Rupture
Study type: Observational

Summary: 
      The aim of this study is to compare fetal and maternal outcome in cases of PPROM before 34
      weeks versus after 34 weeks.
    

Detailed description: 
      The data will be retrieved from the archival files and analyzed
    

Intervention name(s): rupture of membrane
Intervention type(s): Biological
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        pregnant female with history of rupture membrane
Contraceptive Effectiveness Trial of Cellulose Sulfate Gel
Condition: Contraception
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the contraceptive effectiveness of cellulose sulfate vaginal gel in
      preventing pregnancy when used for 6 months.
    

Detailed description: 
      Cellulose sulfate has been shown in preclinical studies to have both contraceptive and
      antimicrobial properties. Clinical safety studies have shown it to be safe for use up to six
      days in women and 7 days in men, and ongoing studies are assessing its safety for twice daily
      use for 14 days in women. This study will evaluate its contraceptive effectiveness in women
      who use it for 6 months.
    

Intervention name(s): Cellulose sulfate vaginal gel
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
SMART Project in Preventing Skin Cancer
Condition: Skin Carcinoma
Study type: Interventional

Summary: 
      This pilot clinical trial studies how well Self Monitoring And Readiness Texting (SMART)
      project works in sun exposure and protection behaviors. Measuring how behavior tracking and
      individually tailored messages affect risk behaviors in patients with skin cancer may help
      doctors plan the best prevention plan and decrease national melanoma incidence and mortality.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To test the effects of a behavior tracking and individually-tailored daily text message
      intervention on sun protection and exposure behaviors and to see if these techniques will be
      most effective in conjunction or separately.

      SECONDARY OBJECTIVES:

      I. To examine mediators in the effects of the intervention on safe sun behaviors, based on
      Fishbein?s Integrative Model.

      OUTLINE: Patients are randomized to 1 of 4 study arms.

      ARM I (SELF-MONITORING): Patients complete tanning and sun protection usage entries daily for
      14 days.

      ARM II (TEXT MESSAGES): Patients receive individualized text messages based on baseline
      assessment of tanning motives (appearance, enjoyment, social) daily for 14 days.

      ARM III (COMBINED GROUP): Patients complete tanning and sun protection usage entries and also
      receive individualized text messages daily for 14 days.

      ARM IV (CONTROL GROUP): Patients complete study assessments.

      After completion of study, patients are followed up at 2 weeks.
    

Intervention name(s): Compliance Monitoring; Health Telemonitoring; Questionnaire Administration
Intervention type(s): Behavioral; Other; Other
Intervention description(s): Record behavior; Receive health monitoring text messages; Ancillary studies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Once Weekly Parathyroid Hormone for Osteoporosis
Condition: Osteopenia; Osteoporosis
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 3

Summary: 
      Daily parathyroid hormone (PTH) is approved by the FDA for the treatment of osteoporosis.
      This study will evaluate the safety and effectiveness of PTH when given once a week.
    

Detailed description: 
      In osteoporosis, skeletal bone mass and strength are so reduced that fractures occur after
      only modest levels of mechanical stress that would not harm normal bone. Fractures of the
      hip, spine, and wrists are most typical, though fractures of the ribs, pelvis, and humerus
      also occur. Research has shown that hip fractures cause a 10% to 20% increase in mortality,
      and the cost of all osteoporotic fractures is estimated to be $6.14 billion in health care
      costs and lost earnings per year. The most common form of osteoporosis is postmenopausal
      osteoporosis. A reduction in bone mineral density of approximately 1% to 2% per year is
      observed for the first 3 to 5 years after the onset of menopause, then 0.5% to 1% per year
      thereafter.

      PTH was recently approved by the FDA as a daily treatment for osteoporosis. However, PTH must
      be self-injected, is very expensive, and has been associated with worrisome side effects. The
      currently approved formulation of daily PTH self-injections is practical for only a small
      proportion of people with osteoporosis. A once weekly formulation could significantly
      decrease cost, difficulty of administration, and risks and side effects associated with daily
      use of PTH. A once weekly injection by a caregiver would also make PTH accessible to
      populations for whom daily self-injection may not be practical, such as the very elderly or
      those in assisted living or nursing homes. This study will evaluate the safety and
      effectiveness of once weekly PTH dosing for women with osteoporosis.

      Women will be randomized to receive either PTH or placebo. Women will self-administer
      injections daily for 4 weeks, then once weekly for 48 weeks. All women will receive calcium
      and vitamin D supplements daily. Women will visit the clinic six times over the course of a
      year and will provide urine and blood samples at each visit. Bone mineral density will be
      measured at 6 and 12 months.
    

Intervention name(s): Teriparatide; Placebo teriparatide
Intervention type(s): Drug; Drug
Intervention description(s): Synthetic human parathyroid hormone; Placebo injections
Intervention MeSH terms: Teriparatide
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Treatment
Study Evaluating Safety, Tolerability, And Action Of OAP-189 In Subjects With Type 2 Diabetes On Metformin
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to evaluate the safety, tolerability, and activity of OAP-189 in subjects
      with type 2 diabetes who are taking metformin for their diabetes.
    


Intervention name(s): OAP-189; placebo comparator
Intervention type(s): Drug; Drug
Intervention description(s): Group 1: OAP-189 BID (0.2 mg BID) x 7 days Group 2: OAP-189 (0.4 mg BID) x 7 days Group 3: OAP-189 QD (0.9 mg x 7 days followed by 1.2 mg x 7 days; MR formulation) Group 4: OAP-189 QD (1.2 mg x 7 days followed by 1.6 mg x 7 days; MR formulation) Group 5: OAP-189 QD (1.2 mg x 7 days followed by 1.6 mg x 7 days; different MR formulation) Group 6: OAP-189 QD (1.2 mg x 7 days followed by 1.6 mg x 7 days; different MR formulation); Group 1 & 2: PBO x 7 days BID Group 3: PBO QD x 14 days Group 4: PBO QD x 14 days Group 5: PBO QD x 14 days Group 6: PBO QD x 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Intake of Beta-glucan and Postprandial Regulation of Blood Glucose Metabolism in Healthy Subjects
Condition: Post Prandial Blood Glucose; Gut Microbiota; Satiety
Study type: Interventional

Summary: 
      The overall aim is to investigate the intake of beta-glucan in relation to glucose metabolism
      and satiety in a postprandial study with healthy subjects. The potential effects will be
      related to changes in the gut microbiota, the circulating levels of short chain fatty acids,
      inflammation and gene expression in peripheral mononuclear blood cells
    

Detailed description: 
      The intervention study will have a fixed order, cross-over design with three test meals
      containing low (0.5 g / 100 g of product), medium (3.5 g / 100 g of product) and high (8 g /
      100 g product) amount of beta -glucans, respectively. The test meals are in the form of
      cereals. All participants will eat the three test meals three constitutive days with 2 weeks
      apart. At day four, the participants will perform a postprandial glucose test (OGTT, 75 g
      glucose in 150 ml water) at Oslo and Akershus University College. Blood samples will be taken
      before and at different time points after glucose test.

      At the screening visit the participants will be asked to limit the intake of dietary fiber
      from grains two weeks prior to the baseline visit (0) and during the study. Otherwise,
      participants will be asked not to change their diet and exercise habits during the study
      period.

      At the baseline visit (visit 0) an OGTT will be performed. OGTT will also be performed at
      visit 1, 3 and 5 after intake of low, medium and high beta-glucan, respectively.

      The participants will receive the test meals at visit 1, 2 and 4.
    

Intervention name(s): 0.5 g beta-glucan; 3.5 g beta-glucan; 8 g beta-glucan
Intervention type(s): Other; Other; Other
Intervention description(s): Dietary cross-over study with beta-glucan fiber; Dietary cross-over study with beta-glucan fiber; Dietary cross-over study with beta-glucan fiber
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Intervention With cross-over design. Three test meals will be tested.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: beta-glucan; Blood glucose; Gut microbiota; Satiety; Dietary intervention
Correlation of Length of Index Finger to Vertical Dimensions of Occlusion for Edentulous Patients
Condition: Patient Satisfaction; Dental Prosthesis; Edentulous Jaw
MeSH terms: Jaw, Edentulous; Mouth, Edentulous
Study type: Interventional

Summary: 
      This study is a randomized clinical trial comparing the conventional method of recording
      occlusal vertical dimension using Willis gauge from the base of the nose to the base of the
      chin with the other method using vernier caliper for the length of the index finger to access
      the satisfaction level of edentulous patients acquiring complete dentures.
    

Detailed description: 
      This study was to apply the anthropometric methods to correlate the length of fingers to
      occlusal vertical dimensions and also by using the Willis Method to assess the occlusal
      vertical dimension for edentulous patients and assess satisfaction by comparing both the
      methods for patients who are in the process of acquiring complete dentures. Furthermore,
      conventional methods are applied most commonly for the recording of occlusal vertical
      dimensions. This study also bridged the knowledge gap among clinicians to adapt to a
      different methodology for recording the VDO using the anthropometric measurement of fingers
      which would improve denture satisfaction. Therefore, a total of 71 patients were selected for
      this study, having lost their OVD due to the complete absence of teeth and having no history
      of maxillofacial or orthognathic surgery, nor any skeletal deformities or disfigurement of
      fingers. The measurements were made at the appointment for jaw relations records in which the
      length of the fingers was measured with a digital Vernier caliper and also the conventional
      methods were applied for recording the occluding vertical dimensions which included recording
      the distance from the base of the nose septum (Subnasion - Sn) to the base of the chin
      (Menton - Me) (Sn-Me). The length of the index finger (2D) was recorded and a correlation was
      found between Sn-Me and finger length.
    

Intervention name(s): Finger lengths; Conventional method
Intervention type(s): Procedure; Procedure
Intervention description(s): Vernier caliper was used to measure finger length; Gillis gauge was used to measure occlusal vertical dimension
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Occlusal vertical dimension, edentulous patients,