bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Salivary Bacteria and Post Brushing
Condition: Salivary Bacteria Levels
Study type: Interventional
Phase: Phase 3

Summary: 
      Research study to compare the effects of brushing with two commercially available toothpastes
      on salivary bacteria after brushing
    


Intervention name(s): Fluoride; Triclosan/Fluoride
Intervention type(s): Drug; Drug
Intervention description(s): Whole mouth brushing for 7 days; Brush whole mouth twice daily for 7 days
Other intervention name(s): fluoride toothpaste (Colgate Great Regular Flavor toothpaste); triclosan/fluoride toothpaste (Colgate Total toothpaste)
Intervention MeSH terms: Listerine; Triclosan; Fluorides; Sodium Fluoride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Cardiovascular Responses to Spartathlon Running
Condition: Disorder Heart
MeSH terms: Heart Diseases
Study type: Interventional

Summary: 
      The aim of this study is to examine the cardiovascular effects of ultramarathon running and
      their relation to performance.
    

Detailed description: 
      The purpose of the study is to determine the changes of cardiovascular morphology and
      function after an ultramarathon race. 50 entrants to the "Spartathlon 2017" 246-km running
      race will participate in the study. Cardiac and arterial morphology and function tests will
      be conducted one day before the race and within 20 minutes of race completion.
    

Intervention name(s): 246-km running
Intervention type(s): Other
Intervention description(s): Spartathlon 2017
Intervention model: Single Group Assignment
Intervention model description: athletes participating in the ultra marathon running
Masking: None (Open Label)
Primary purpose: Screening
EEG@HOME (Phase 1 of the Project)
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional

Summary: 
      The goal of this project is the development of an EEG-cap (min. 21 electrodes) with
      user-friendly active dry electrodes that meets the expectations of the users regarding
      comfort and esthetics, without losing sight of the functional and technical demands for
      recording high quality EEG signals. The purpose is to use the EEG-cap to investigate clinical
      neurological disorders (e.g. epilepsy). The EEG-cap could also be used at home so that
      hospital admission in the EMU can be avoided for some patients and an increasing number of
      patients can be examined.

      In Phase 1 of the project epilepsy patients and their family will be interviewed about their
      personal experiences with the condition, EEG registrations, daily life, ... . In addition
      EEG-technologists and neurologists will be interviewed about their experience with EEG
      registrations and what features their dream EEG-cap would have. The purpose is to gain
      insight in the wishes and expectations of the end users so we can take this into account when
      designing of the EEG-cap. This interview is anticipated to take approximately 1 hour.

      Minimum 5 - maximum 50 patients and their family will be interviewed. Minimum 5 - maximum 50
      EEG-technologists or neurologists will be interviewed.

      The results of the interviews will be analysed by the design company pilipili nv.
    


Intervention name(s): Interview
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Topical Tazarotene in Treating Patients With Basal Cell Skin Cancer and Basal Cell Nevus Syndrome on the Face
Condition: Neoplastic Syndrome
MeSH terms: Basal Cell Nevus Syndrome; Neoplasms; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as tazarotene, work in different ways to stop the
      growth of tumor cells, either by killing the cells or by stopping them from dividing.

      PURPOSE: This phase II trial is studying topical tazarotene to see how well it works in
      treating patients with basal cell skin cancer and basal cell nevus syndrome on the face.
    

Detailed description: 
      OBJECTIVES:

        -  Determine whether topical tazarotene, administered over a period of 18 months as a
           chemopreventive agent, reduces the incidence of basal cell carcinomas (BCCs) on treated
           skin in patients with basal cell nevus syndrome (BCNS).

        -  Expand and refine chemopreventive strategies in patients with BCNS who are at high risk
           for the development of BCCs.

      OUTLINE: This is an open-label, multicenter study.

      Patients apply topical tazarotene cream to the face once daily for 18 months in the absence
      of unacceptable toxicity.
    

Intervention name(s): tazarotene
Intervention type(s): Drug
Intervention description(s): Tazarotene is a member of the acetylenic class of retinoids.
Other intervention name(s): tazorac
Intervention MeSH terms: Tazarotene
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nevoid basal cell carcinoma syndrome; basal cell carcinoma of the skin
Long-term Retinal Changes After Topical Citicoline Administration in Patients With Mild Signs of Diabetic Retinopathy in Type 1 Diabetes Mellitus.
Condition: Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy; Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Citicoline (cytidine-5'-diphosphocholine) is an essential precursor in the synthesis of
      phosphatidylcholine, a component of cell membranes. Several experimental in vitro and in vivo
      studies have suggested that citicoline plays a neuroprotective role.

      A recent clinical study has shown that treatment with topical citicoline induces, after 60
      days of therapy, a significant improvement in the ganglion cell function .In addition topical
      citicoline has been demonstrated in vivo a neuroprotective effect in preventing diabetic
      retinopathy .

      The Investigators want to evaluate if citicoline may reduce the progression of retinal damage
      in patients with mild diabetic retinopathy.
    

Detailed description: 
      The investigators evaluated patients with mild signs of diabetic retinopathy (DR) treated
      with eye-drop solution with citicoline ( OMk2 ophthalmic solution).

      All patients was randomized in two groups (10:10), one receiving topical administration of
      OMk2 ophthalmic solution for 36 months and one group receiving only the excipients of OMk2
      (placebo).

      Omk2 ophthalmic solution and the placebo will be used for 36 months three times/day.

      They will undergo a complete ocular examination at baseline and at 6-, 12-, 18-, 24-, 30- and
      36- months after treatment.
    

Intervention name(s): OMK2 group; Placebo group
Intervention type(s): Other; Other
Intervention description(s): topical administration of OMk2 ophthalmic solution for 36 months three times/day; topical administration of ophthalmic placebo solution for 36 months three times/day
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, interventional, randomized, double-masked, monocentric pilot study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: citicoline; neuropathy
Attention Bias Modification Treatment for Major Depressive Disorder in Adolescents
Condition: Major Depressive Disorder, Single Episode, Unspecified
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      In this study, we test whether a two-week 8-session neutral attention bias modification (ABM)
      training and a two-week 4-session positive ABM could reduce depressive symptoms relative to
      placebo controls in adolescents with major depressive disorder at posttraining and follow-ups
      during one year.
    

Detailed description: 
      Depression is a common health problem in adolescents. Negative attentional bias has been
      theorized to play a critical role in the onset and maintenance of depression, suggesting that
      reduction of such biases may treat symptoms of depression. Recent studies have shown that
      attention bias modification(ABM) training could reduce depressive symptoms in both dysphoria
      and previously depressed adult patients.To test the effectiveness of ABM training on the
      treatment of depressive symptoms in depressed adolescents, we designed a randomized,
      double-blind, placebo controlled trial in adolescents with major depressive disorder(MDD).
    

Intervention name(s): ABMT
Intervention type(s): Behavioral
Intervention description(s): During a two-week period, 8 sessions of a modified dot probe task for attentional bias modification training (ABMT) condition, 8 sessions of a classic dot probe task for placebo training (PT) condition.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: depression，adolescent，attention bias，modification
Comparison of DTaP-HB-PRP~T Combined Vaccine to Tritanrix-HepB/Hib™, Both Given Concomitantly With Oral Polio Vaccine
Condition: Diphtheria; Tetanus; Pertussis; Hepatitis B; Haemophilus Infections
MeSH terms: Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Haemophilus Infections; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to support the registration of the pentavalent DTaP-HB-PRP~T
      vaccine in countries that follow the World Health Organization-Expanded Program of
      Immunization (WHO-EPI) schedule.

      The primary objective is:

        -  To demonstrate that the pentavalent DTaP-HB-PRP~T combined vaccine does not induce a
           lower immune response than Tritanrix-HepB/Hib™ in terms of the seroprotection rate to
           hepatitis B (HB) one month after a 3-dose primary series at 6, 10, and 14 weeks of age.

      The secondary objectives are:

        -  To describe in each group the immunogenicity parameters one month after the 3-dose
           primary series at 6, 10, and 14 weeks of age; and

        -  To evaluate the overall safety in terms of any adverse events in the first 28 days after
           each injection and any serious adverse events during the entire trial.
    


Intervention name(s): DTaP-HB-PRP~T vaccine + OPV; Tritanrix-HepB/Hib™ + OPV vaccine; Oral Polio Vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; Oral co-administered with study vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Diphtheria; Tetanus; Pertussis; Hepatitis B Hansenula (HB); Haemophilus influenzae type b; Haemophilus Influenzae
Improving Identification of Mental Health/Substance Use Disorders in HIV Primary Care: Pilot Clinical Response
Condition: HIV Infections
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      This research is a feasibility pilot of an intervention to respond to positive screening
      tests for mental health(MH) and substance use (SU) captured through the Patient Reported
      Outcomes questionnaires (PROs). The PROs are currently performed in the clinic, however, the
      results are neither reviewed with patients nor transmitted to providers. This pilot assesses
      the feasibility of moving the PROs into the clinical realm by having patients review the PRO
      results, identifying an issue to discuss at the patient's next HIV primary care visit, and
      determining whether this process increases discussion of MH and SU disorders in the
      subsequent clinical visit and/or increases referrals to MH and/or SU treatment.
    


Intervention name(s): Patient Designated Positive Screen Shared with Provider
Intervention type(s): Behavioral
Intervention description(s): Patient Designated Positive Screen Shared with Provider -- In the intervention, participants will be given the opportunity to determine which positive screen, if any, that the participant would like to discuss with the participant's provider at the next HIV primary care appointment. The participant will be notified that all positive screens will be shared with the provider prior to their next HIV primary care visit, and that any positive screen the patient has chosen to discuss with the provider will be specified. The provider will receive the PROs result (score, interpretation, and recommendation) prior to their next HIV primary care visit
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
PET/MRI Study of Men With Highly Suspicious MRI Lesions That Showed no Clinically Significant Prostate Cancer Following MRI Fusion Targeted Biopsy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      The principal aim of this study is to determine if PET/MRI imaging with 18-F fluciclovine
      (Axumin) identifies those men with false negative MRI fusion targeted biopsy (MRFTB) of
      PI-RADS 4 and 5 lesions. PI-RADS 4 and 5 MRI lesions are highly suspicious for clinically
      significant prostate cancer and require future repeat MRI imaging and possible repeat
      prostate biopsy depending on the results of the repeat MRI. Men, who had negative MRFTB
      within past 12 months of PI- RADS 4 or 5 MRI lesion will be included in this diagnostic
      study. The repeat MRI is standard of care at NYU Langone Health. The investigation aspect of
      the study is to perform an Axumin scan the same day as the MRI. Those men with persistent
      highly suspicious lesions will under MRFTB. The biopsy results will be compared with
      intensity of Axumin uptake within the prostate. The urologist will have the discretion to
      biopsy Axumin avid lesions not detected by MRI.
    


Intervention name(s): Fluciclovine PET/MRI
Intervention type(s): Diagnostic Test
Intervention description(s): It is unknown how many negative MRFTBs of PI-RADS 4 lesions are false negative biopsies or false positive tests.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Gemcitabine/Vinorelbine Versus Gemcitabine/Cisplatin Versus Gemcitabine/Capecitabine in Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Development of an active second-line treatment option for metastatic breast cancer patients
      previously pre-treated with anthracyclines and taxanes in neoadjuvant, adjuvant or palliative
      settings.

      For each randomisation arm, 47 patients will be included. The trial was performed as a
      2-stage phase II study according to the optimal design by Simon with overall response rate as
      the primary objective.

      Study Design:

      Arm A Gemcitabine 1000 mg/m2 d1, 8; Vinorelbine 25 mg/m2 d1, 8 q 3 weeks

      Arm B Gemcitabine 1000 mg/m2 d1, 8; Cisplain 30 mg/m2 d1, 8 q 3 weeks

      Arm C Gemcitabine 1000 mg/m2 d1, 8; Capecitabine 1650 mg/m2 oral d1-14 q 3 weeks
    


Intervention name(s): gemcitabine; cisplatin; vinorelbine; capecitabine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Gemcitabine; Capecitabine; Vinorelbine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gemcitabine; vinorelbine; cisplatin; capecitabine; pretreated metastatic breast cancer
The Turkish Version of the Shanghai Elbow Dysfunction Score
Condition: Elbow Fracture; Stiffness of Elbow, Not Elsewhere Classified; Orthopedic Disorder; Assessment, Self
MeSH terms: Musculoskeletal Diseases; Elbow Fractures
Study type: Observational

Summary: 
      The Shanghai Elbow Dysfunction Score (SHEDS) is originally developed in English to evaluate
      elbow function in patients with elbow stiffness. The purpose of this study is to translate
      and cross-culturally adapt the SHEDS instrument into Turkish and investigate its psychometric
      properties.
    

Detailed description: 
      The Shanghai Elbow Dysfunction Score (SHEDS) is originally developed in English to evaluate
      joint function in patients with elbow stiffness. The purpose of this study is to translate
      and cross-culturally adapt the SHEDS instrument into Turkish and investigate its psychometric
      properties. Approximately seventy patients with elbow limitation will be included. For
      cross-cultural adaptation, two bi-lingual translators will use the back-translation
      procedure. Within a 3-to-5-day period after the first assessment, the participants will
      complete the Turkish version of SHEDS (SHEDS-T) to evaluate test-retest reliability.
      Cronbach's alpha (α) will use to assess internal consistency. The correlation with the
      Turkish version of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, the
      Turkish version of Mayo Elbow Performance Score, and Short Form-12 will be determined to
      check the validity. Responsiveness and floor and ceiling effects will be detected.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All participants are patients who had sustained an elbow fracture and are treated
        surgically. The participants with elbow stiffness after an elbow fracture are directed for
        assessment following a confirmation by an orthopaedist that the bone fracture healed based
        on the physical examinations and diagnostic imaging.
      
Keywords: Elbow; Reliability; Validity; Function; Fracture
The Effects of Mindfulness Based Stress Reduction on Patients With Traumatic Brain Injury
Condition: Traumatic Brain Injury; Brain Injury; Stress
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional

Summary: 
      This study is studying the effects of Mindfulness Based Stress Reduction (MBSR), a standard
      protocol of gentle yoga and breath meditation, on patients with Traumatic Brain Injury (TBI).
      The investigators are testing whether this intervention can help improve the stress response
      and increase resiliency and mindfulness for patients with TBI, which may lead to improved
      symptoms and neurocognitive function.
    


Intervention name(s): Mindfulness Based Stress Reduction
Intervention type(s): Other
Intervention description(s): An 8 week protocol of stress reduction sessions using gentle yoga and breath meditation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Intravenous Acetaminophen for Non-Narcotic Postoperative Pain Management Following Knee Arthroscopy
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this randomized, placebo controlled, single blind study is to determine if
      postoperative pain levels, as measured by a verbal numeric pain rating scale (VNRS), are
      reduced with the administration of IV acetaminophen when compared to a control group.
      Particular focus will be on the postoperative opioid consumption. In addition, we will
      ascertain if the total time the participant is in the PACU differs in those who receive the
      IV acetaminophen versus those who do not.
    

Detailed description: 
      This is a randomized, placebo controlled, single blind study of intravenous (IV)
      acetaminophen in a postoperative arthroscopy patient population. Although use of this
      medication as a non-narcotic analgesia has been validated in other patient populations such
      as post operative pelvic and abdominal surgeries, it has not been demonstrated in those who
      have recently undergone knee arthroscopy with or without chondroplasty. In this study all
      participants will be injected with a standard of care intra-articular dose of ropivacaine
      HCl, .2% (Naropin) prior to transfer to the Post Anesthesia Care Unit (PACU). Each will be
      randomized 1:1 to receive IV acetaminophen in 100ml of 0.9% NS (treatment group) or a 100 ml
      0.9 % NS placebo (control).

      The PACU nursing staff will periodically ascertain the participants' pain scores on a 0-10
      scale. All other pain medication or related treatment will be recorded. Statistical analysis
      will be done to determine if there is a difference in pain scores between the treatment
      versus control group. Further evaluation will examine if opioid consumption and total time in
      PACU differs between groups.
    

Intervention name(s): Intravenous Acetaminophen; Placebo (0.9% Normal Saline infusion)
Intervention type(s): Drug; Drug
Intervention description(s): Participants randomized to intravenous acetaminophen (Ofirmev) will receive an infusion of Ofirmev in 100 ml of 0.9 NS according to manufacturer's recommendations related to subject's weight.; Infusion of 100 ml of 0.9% NS
Other intervention name(s): Ofirmev; NS
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Pain, Postoperative; Ofirmev; Acetaminophen; Analgesics, Non-Narcotic; Arthroscopy
A Study Testing How BI 655130 Works in Patients With Fistulizing Crohn's Disease
Condition: Crohn Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study in adults with Crohn's Disease who also have fistulas near the anus. The
      study has 2 parts. The first part is to find out more about what causes the fistulas. In this
      part of the study, tissue samples are taken from patients. The second part of the study tests
      whether a medicine called spesolimab (BI 655130) helps patients with Crohn's Disease.

      Participants get study medication for 24 weeks. The participants are put into 2 groups. It is
      decided by chance who gets into which group. One group gets an intravenous drip that contains
      spesolimab every 4 weeks. The other group gets a placebo drip every 4 weeks. The placebo drip
      looks like the spesolimab drip, but contains no medicine.

      The doctors regularly examine fistulas of the participants. The results of the fistula
      examinations are compared between the groups. The doctors also check the general health of
      the patients.
    


Intervention name(s): Spesolimab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Spesolimab 1200 milligram intravenously every 4 weeks (week 0, 4, 8, 12, 16 and 20). At week 12 Placebo patients without combined perianal fistula remission were switched to spesolimab and were treated with spesolimab 1200 milligram intravenously every 4 weeks (week 12, 16 and 20).; Placebo intravenously every 4 weeks (week 0, 4, 8). At week 12 achievement of combined perianal fistula remission was determined, patients without combined perianal fistula remission were switched to spesolimab and were treated with spesolimab 1200 milligram intravenously every 4 weeks (week 12, 16 and 20). Patients with combined perianal fistula remission remained on Placebo and were treated with placebo intravenously every 4 weeks (week 12, 16 and 20).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment