bioihbjkbjnl/mcl2 huggingface dataset:
Study to Investigate the Efficacy of an Occluding Dentifrice in Providing Relief From Dentine Hypersensitivity
Condition: Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional
Phase: Phase 4

Summary: 
      This will be a single centre, two week, randomised, examiner blind, two treatment arm,
      parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected
      test teeth), controlled study, in participant with at least two sensitive teeth that meet the
      study criteria at the Screening and Baseline visits. The study will be conducted in
      participants in good general health, with pre-existing self-reported and clinically diagnosed
      tooth sensitivity at screening.
    


Intervention name(s): Stannous Fluoride Dentifrice; Sodium monofluorophosphate Dentifrice
Intervention type(s): Other; Other
Intervention description(s): Experimental dentifrice containing 0.454%w/w stannous fluoride (1100ppm fluoride); Dentifrice containing 0.76% w/w sodium monofluorophosphate (1000ppm fluoride)
Intervention MeSH terms: Fluorides; Tin Fluorides; Fluorophosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluate Bioequivalence of Micafungin (50mg/Vial)
Condition: Invasive Candidiasis
MeSH terms: Candidiasis; Candidiasis, Invasive
Study type: Interventional
Phase: Phase 4

Summary: 
      A randomized, single-dose, two-way crossover study to evaluate bioequivalence of two
      formulations of micafungin (50 mg/vial) after intravenous infusion of 50 mg micafungin in
      healthy volunteers under fasting conditions
    


Intervention name(s): Micafungin
Intervention type(s): Drug
Intervention description(s): Pharmacokinetic study under fasting conditions
Intervention MeSH terms: Micafungin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: An open-label, randomized, balanced, two-treatment, two-period, twosequence, single dose, two-way crossover study
Masking: None (Open Label)
Primary purpose: Other
Evaluation of Two Different Toothpastes for Clinical Management of Extrinsic Stains.
Condition: Extrinsic Staining of Tooth - Medication
MeSH terms: Tooth Discoloration
Study type: Interventional

Summary: 
      The aim of the study is to assess the efficacy of Blanx Black Toothpaste against extrinsic
      stains of teeth.

      Patients who sign the informed consent will participate to the study.

      At the baseline, the collection of Plaque Index, modified Lobene index and Bleeding Index
      will be performed, giving the instruction for a proper home oral hygiene. Professional
      supragingival and subgingival dental hygiene with piezoelectric will be performed. Then,
      patients will be randomly divided into two groups:

        -  Trial Group will use Blanx Black Toothpaste (2 minutes brushing) twice a day for the all
           the study duration;

        -  Control Group will use Colgate Sensation White Toothpaste (2 minutes brushing) twice a
           day.

      Patients will be reevaluated after 10 days, after 1 month and after 3 months, collecting
      again the indices and improving home oral care.
    

Detailed description: 
      The aim of the study is to assess the efficacy of Blanx Black Toothpaste against extrinsic
      stains of teeth.

      For this purpose, patients addressing to the Dental Hygiene Unit that agree to participate to
      the study will be enrolled after signing the informed consent.

      At the baseline, the collection of Plaque Index, modified Lobene index and Bleeding Index
      will be performed, giving the instruction for a proper home oral hygiene. Professional
      supragingival and subgingival dental hygiene with piezoelectric will be performed. Then,
      patients will be randomly divided into two groups:

        -  Trial Group will use Blanx Black Toothpaste (2 minutes brushing) twice a day for the all
           the study duration;

        -  Control Group will use Colgate Sensation White Toothpaste (2 minutes brushing) twice a
           day.

      Patients will be reevaluated after 10 days, after 1 month and after 3 months. After the
      reinforcement of home oral hygiene, the above mentioned indices will be collected.
    

Intervention name(s): Blanx Black Toothpaste; Colgate Sensation White
Intervention type(s): Other; Other
Intervention description(s): Use of Blanx Black Toothpaste twice a day per at least 2 minutes.; Use of Colgate Sensation White Toothpaste twice a day per at least 2 minutes
Intervention MeSH terms: Listerine; Sodium Fluoride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: toothpaste; extrinsic stains
Peripheral Effects of Endotoxin on Insulin Resistance
Condition: Healthy
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The aim of the study is to isolate the direct effects of endotoxin on glucose, lipid and
      protein metabolism. Eight healthy volunteers are enrolled. The hypothesis is that endotoxin
      will induce insulin resistance, lypolysis and proteolysis acutely.
    


Intervention name(s): USP endotoxin
Intervention type(s): Biological
Intervention description(s): Continuous intra-arterial infusion
Other intervention name(s): USP Endotoxin, LOT: G3E069
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Endotoxin; Insulin resistance; Lipolysis; Proteolysis; Intracellular Insulin Signaling; Regional effects of inflammation/endotoxin
Peers for Promoting Adolescent Transplant Health
Condition: Behavior and Behavior Mechanisms
Study type: Interventional

Summary: 
      Adolescents with solid organ transplants have poorer outcomes than adults, and do not respond
      as well to post-rejection treatment. In addition to well-recognized declines in individual
      health-related quality of life, premature graft loss creates considerable health and economic
      burdens. High nonadherence rates among adolescents are believed to contribute majorly to
      rejection, premature allograft dysfunction and failure. Studies suggest that a
      telephone-based peer mentoring approach, with texting and e-communication, is a promising,
      practical means to promote medication adherence in adolescent solid organ transplant
      recipients. The study's main objectives are 1) to determine the efficacy of peer mentoring to
      improve medication adherence and health-related quality of life vs. usual care in adolescents
      and young adults with solid organ transplants, and 2) to determine the mechanisms through
      which peer mentoring impacts medication adherence and health-related quality of life.
    

Detailed description: 
      The investigators will conduct a single-center Phase II randomized clinical trial in which
      adolescents ages 14-23 and greater 3 months post solid organ transplant will receive either a
      peer mentor or usual care. The investigators will assess changes in quality of life from
      baseline to one year post-study entry. The investigators will also examine adherence changes
      over the same time frame using pharmacy refill data and a questionnaire. Peer mentors will
      provide social support and promote subject self-efficacy primarily via e-communication.
      Changes in social support and self-efficacy will be measured over a one-year period.
    

Intervention name(s): Peer Mentoring; e-Communication with mentor
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects will be assigned a peer mentor who will provide social support primarily via e-communication. They will also meet in-person at study entry, 6 months and 1-year.; Subjects will interact on a mutually agreeable basis via their choice of text messaging, Facebook, phone calls, emails, and other formats
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: kidney; renal; transplant; transplantation; adolescent; pediatric; mentor; mentoring; medication; adherence; immunosuppressant; heart; liver
Misoprostol With Intrauterine Device Insertion
Condition: Contraception
Study type: Interventional

Summary: 
      The purpose of this study is to see if using misoprostol (a medication that softens the
      cervix) before placing an intrauterine device for contraception reduces pain in women who
      have never delivered a baby.
    

Detailed description: 
      The investigators intend to conduct a randomized double blind study at Oregon Health and
      Science University and Planned Parenthood of the Columbia Willamette.

      Subjects will be approached only after deciding to get an intrauterine. When the participants
      return for intrauterine device placement, at 90 minutes prior to the procedure half will
      receive misoprostol and half will receive placebo. The subjects will be asked to rate their
      level of pain at specific points during the insertion. Providers will be asked to mark
      whether or not additional dilation was required as well as their perceived ease of
      intrauterine device placement.
    

Intervention name(s): Misoprostol; Magnesium Oxide
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Place 2 tablets between the teeth and cheek and allow to dissolve for 30 minutes.; Place 2 tablets between the teeth and cheek and allow to dissolve for 30 minutes.
Other intervention name(s): prostaglandin; Magnesium; Placebo
Intervention MeSH terms: Misoprostol; Magnesium Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: intrauterine device; cervical dilation; nulliparous women; pain management
The Effects of Resistance Exercises in Glycemic Control of Women With Gestational Diabetes
Condition: Gestational Diabetes
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional

Summary: 
      The object of this study is to evaluate patients with a diagnosis of GD who are included in a
      program of RE carried out with rubber tubes, comparing the frequency of women who will use
      insulin in the group who will participate in the program with the group that won't do the
      exercises, and to verify the impact of the program on the adequacy of capillary glycemic
      control of the pregnant women.
    


Intervention name(s): Resistance exercises
Intervention type(s): Other
Intervention description(s): Resistance exercises program consisting of 08 different exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Gestational Diabetes; Resistance Exercise; Pregnancy; Insulin
Phase IV Clinical Trial of an Influenza Split Vaccine Anflu
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the safety and immunogenicity of the three consecutive lots of an seasonal split
      influenza vaccine Anflu in adults, a randomized, double-blind and controlled clinical trial
      was conducted in 560 subjects in Tianjin City of China.
    


Intervention name(s): seasonal split influenza vaccine; seasonal split influenza vaccine; seasonal split influenza vaccine; seasonal split influenza vaccine
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime; 0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime; 0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime; 0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Dog-Assisted Therapy in Dentistry
Condition: Dental Anxiety; Pediatric Dentistry; Animal Assisted Therapy
Study type: Interventional

Summary: 
      Dog-assisted therapy (DAT) is used in several contexts within various areas of health care.
      One documented effect is that the proximity of a dog may lower anxiety in perceived stressful
      situations. Many individuals are afraid to visit the dentist, and someone to the extent that
      they need medication or anesthesia in order to complete their dental treatment. Based on the
      literature and own empirical observations, the investigators believe that dog-assisted
      therapy in connection with dental care may have a positive effect on children with dental
      anxiety or children that avoid dental care. It is desirable to restrict the use of drugs for
      these patients because of associated risk and side effects.

      The purpose of this pilot study is to evaluate whether using a specially trained therapy dog
      can have a positive effect on children who are afraid in a dental care setting. Eligible
      participants (n=16) will meet twice at the dental clinic; one treatment session with a
      therapy dog in the dental clinic and one without. The therapy dog will be accompanied by a
      certified dog handler. The investigators will measure physiological variations before, during
      and after the treatment session. The guardian will complete validated questionnaires
      portraying the participant's experience of previous dental care. The participant and their
      guardian will also complete validated questionnaires describing their reactions from the two
      treatment sessions. A descriptive log for each session will be completed by the
      investigators.
    


Intervention name(s): Therapydog
Intervention type(s): Procedure
Intervention description(s): Presence of a therapydog during a clinical examination in a dental clinic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Animal-Assisted Intervention; Dog-Assisted Intervention; Dental Care; Questionnaire; Pilot Project; Dental Clinic
Combined CO2 Fractional Laser With Bimatoprost 0.03% Treatment of Alopecia Areata
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The goal of this study is to evaluate the efficacy and safety of combined CO2 fractional
      laser with Bimatoprost 0.03% as novel treatment of alopecia areata.

      The main question to study is will the bimatoprost facilitate hair growth if added to
      fractional CO2 laser treatment in Alopecia areata.
    

Detailed description: 
      The study included 30 patients who were diagnosed clinically and dermoscopically as alopecia
      areata with age ranged between 16-55 years. The patients are divided into 2 groups: Group I,
      received fractional laser sessions with immediate and daily Bimatoprost application and Group
      II, received only frequent Laser sessions. Laser sessions were given to each patch once every
      3 weeks, the procedure was repeated for 3 times.
    

Intervention name(s): Bimatoprost 0.03% solution; CO2 fractional laser
Intervention type(s): Drug; Device
Intervention description(s): Topical Bimatoprost 0.03% solution; CO2 fractional laser treatment
Other intervention name(s): Topical treatment of skin lesions; laser treratment
Intervention MeSH terms: Bimatoprost
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In this design, subjects are randomized to 2 study arms and each study arm will be allocated a different intervention. After randomization each participant will stay in their assigned treatment arm for the duration of the study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alopecia areata; Bimatoprost; CO2 Fractional Laser
Assisting HIV-infected Mothers in Disclosing Their Serostatus to Their Children
Condition: HIV
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will develop and evaluate the effectiveness of an intervention designed to assist
      HIV-infected mothers of young children in determining whether and how to appropriately
      disclose their HIV serostatus to their children.
    

Detailed description: 
      HIV is a serious, life threatening illness that requires a lifetime of treatment and disease
      management. Studies have shown that it can be very difficult for infected mothers to decide
      whether and/or when to disclose their HIV serostatus to their uninfected children.
      HIV-infected parents struggle with the fear that their children will be forced to grow up too
      quickly, become worried or depressed, or be angry with their parents once they learn that
      their parents have HIV. Family-based intervention programs have been successful in helping
      facilitate the disclosure process. This study will develop and evaluate the effectiveness of
      an intervention designed to assist HIV-infected mothers of young children in determining
      whether and how to appropriately disclose their HIV serostatus to their children.

      Participants in this study will be randomly assigned to either the intervention or a standard
      of care condition. The intervention will consist of three 75-minute sessions that will focus
      on exploring mothers' concerns, determining children's readiness to receive the news,
      planning for disclosure, and practicing disclosure. Participants will also receive one
      follow-up phone call from the therapist about 3 weeks after the last session. Sessions will
      be scheduled at times that are convenient for the participants and therapists. Follow-up
      visits will include both mothers and their children, and will be held at Months 3, 6, and 9
      following the end of the intervention. Assessments will include readiness to disclose HIV
      serostatus, mental health indicators, and family functioning.
    

Intervention name(s): Teaching, Raising, and Communicating with Kids (TRACK); Treatment as usual
Intervention type(s): Behavioral; Other
Intervention description(s): TRACK is cognitive-behavioral treatment designed to improve mother-child communication and parenting skills and prepare caregiver for disclosure of HIV serostatus to child. The treatment consists of three 75-minute sessions that focus on exploring mothers' concerns, determining children's readiness to receive the news, planning for disclosure, and practicing disclosure.; Treatment as usual includes standard care for HIV infected mothers.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Keywords: Disclosure; Serostatus
Study to Evaluate Safety, Tolerability, PK and PD of ALXN1007 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety, tolerability, PK and PD of a single-dose
      of ALXN1007 in healthy volunteers.
    

Detailed description: 
      All subjects will be screened for eligibility after providing signed informed consent. Once a
      subject is determined to be eligible, the subject will be vaccinated with the quadrivalent
      meningococcal conjugate vaccine at least two weeks prior to dosing, if applicable. A total of
      7 dose cohorts will be enrolled sequentially and randomized to receive ALXN1007 or placebo.
      Subjects will receive ALXN1007 or placebo at the clinic and be kept at the clinic for a total
      of 4 days for observation and completion of the required study tests.

      The subjects will return for 8 additional clinic visits to complete the required study tests
      over the next 86 days. The total duration of the study is 90 days from the day of dosing with
      ALXN1007 or placebo.
    

Intervention name(s): ALXN1007; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Single dose, IV; Single dose, IV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy subjects
Valor II: The Valiant Thoracic Stent Graft System Clinical Study
Condition: Thoracic Aortic Aneurysm
MeSH terms: Aortic Dissection; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic
Study type: Interventional

Summary: 
      This study was designed to study safety and effectiveness of the Valiant Thoracic Stent Graft
      to treat thoracic aortic aneurysms.
    

Detailed description: 
      The aorta is a large blood vessel that carries blood away from the heart to the organs in the
      rest of the body. An aneurysm is a weakening in the artery wall that will become a bulge in
      the aorta. If left untreated, this bulge may continue to grow larger and may rupture (break
      open) with fatal consequences. In this research study we are investigating a device that can
      be placed in the aorta to exclude the weakened part of the artery wall and restore blood
      flow. Information will be collected on the performance of the device for 5 years.
    

Intervention name(s): Valiant Thoracic Stent Graft System
Intervention type(s): Device
Intervention description(s): Surgical procedure in which a device is implanted inside the aorta, isolating the diseased area (aneurysm).
Other intervention name(s): Valiant device; Valiant stent graft.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Thoracic Aneurysm; Endovascular Aortic Repair (EVAR); Endovascular Stent Graft; Endograft; Thoracic Aortic Aneurysm; Endovascular procedure; Descending Thoracic Aneurysm; Valiant Stent Graft System
A Study of Single and Repeated Doses of LY3556050 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to conduct blood tests to measure how much LY3556050 is in
      the bloodstream and to determine if any age, gender, or food effects exist. The study will
      also evaluate the safety of LY3556050. This is a 2-part study. In Part 1, single increasing
      doses of LY3556050 will be given orally and participants will be confined for a 5-day period.
      In Part 2, multiple increasing doses of LY3556050 will be given orally and participants will
      be confined for a 14-day period.
    


Intervention name(s): LY3556050; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally.; Administered orally.
Other intervention name(s): CNTX-0290
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science