bioihbjkbjnl/mcl2 huggingface dataset:
Suppressive Antibacterial Therapy With Once-Weekly Secnidazole Granules to Prevent Recurrent Bacterial Vaginosis; A Pilot Study
Condition: Recurrent Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases; Recurrence
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to test the effectiveness Secnidazole to treat recurrent BV.
      Secnidazole is approved for one-time use in acute BV. In this study, the drug will be used
      for recurrent BV, and given weekly for 18 weeks.
    

Detailed description: 
      A single-center prospective pilot study with once-weekly oral secnidazole granule treatment
      of acute condition for two-weeks followed by prophylactic treatment of asymptomatic
      responders with once-weekly secnidazole for 16 weeks, followed by no therapy for 12 weeks.
      The final follow-up evaluation is at week 28.

      Eligible women with a current symptomatic bacterial vaginosis infection (> or = 3 Amsel
      criteria) and a history of at least 2 previous episodes of bacterial vaginosis in the past
      year will be enrolled in the open-label treatment study. All women will be treated with 2g of
      secnidazole granules orally once-weekly for 2 weeks. At the second visit, 3-5 days after
      completion of treatment, women who have a resolution of bacterial vaginosis (asymptomatic and
      < or = 2 Amsel criteria) will continue on once-weekly secnidazole for 16 weeks.

      Patients will be evaluated every 4 weeks for recurrence of bacterial vaginosis. This will
      include questions about symptoms as well as a pelvic examination for assessment of vaginal
      discharge (> or = 3 Amsel criteria). We will also collect any information on other clinical
      evaluations for recurrence and the dates of diagnoses and types of treatments they may have
      received. Those who remain without recurrence during the 16-week suppressive phase will be
      followed for an additional 12 weeks off therapy, with assessment for recurrence at weeks 22
      and 30. Throughout the study, data will be collected on participants' compliance and on the
      occurrence of adverse events.
    

Intervention name(s): Secnidazole 2 GM Oral Granules
Intervention type(s): Drug
Intervention description(s): Once weekly 2g oral secnidazole for 18 weeks
Intervention MeSH terms: Secnidazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Calling the Patient's Name on Recovery From General Anesthesia
Condition: Delayed Emergence From Anesthesia
MeSH terms: Delayed Emergence from Anesthesia
Study type: Interventional

Summary: 
      The purpose of this study is to find if we can shorten the recovery time by calling the
      patient's name during anesthesia reversal.
    


Intervention name(s): Calling the patient's name; Not calling the patient's name
Intervention type(s): Procedure; Procedure
Intervention description(s): calling the patient's name during anesthesia reversal; giving verbal stimulus other than the patient's name during anesthesia reversal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
CBD for Dental Pain
Condition: Odontalgia; Toothache
MeSH terms: Toothache
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaulate CBD as a therapeutic approach for dental pain.
      Eligible subjects presented with emergency dental pain will be give a single dose of
      Epidiolex (FDA-approved CBD) or placebo and will be monitored for 3 hours for pain symptoms
      and psychologic effects.
    

Detailed description: 
      CBD is a non-psychoactive, non-addictive compound of cannabis that has shown analgesic and
      anti-inflammatory properties. Epidiolex is the only FDA-approved oral CBD solution and will
      be the drug of choice in this study.
    

Intervention name(s): Epidiolex 100 mg/mL Oral Solution; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Cannabidiol (CBD): is the primary non-psychoactive and non-addictive compound in cannabis, has already shown potential in treating pain such as arthritis, neuropathic, cancer and chronic pain; Placebo drug will be a solution with the same taste, texture and color as the drug.
Other intervention name(s): Cannabidiol (CBD)
Intervention MeSH terms: Cannabidiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cannabidiol (CBD); Opioid; Dose; Dental; Pain; Epidiolex; CBD
Calibration of a New Reflectance Oximeter.
Condition: Healthy Volunteer
Study type: Interventional

Summary: 
      This study is about the development of a new medical device for the monitoring of of sleep
      disordered breathing. This device is developed by the CEA-LETI-LE2S and will be composed of
      an oximeter, an actimeter in order to measure the activity level of the subject, his state of
      sleeplessness/sleep, and a CO2 partial pressure transcutaneous sensor (PtcCO2).

      Developing this device is realized in several steps : a study (ALMOST) is already in progress
      and its goal is to acquire a database of polysomnography to create automatic algorithms in
      order to detect respiratory disorders with this device under development.

      The main goal of the study is to calibrate the oxymeter under development.
    


Intervention name(s): Calibrate the oximeter ALTITRAINER200®
Intervention type(s): Device
Intervention description(s): During normoxic condition and four situations of hypoxia.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Sleep apnea; Oximeter; Calibration; Oxygen partial pressure
Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Therapy and Nicotine Gum
Condition: Tobacco Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      A comparison of two products for oral nicotine replacement with respect to relief of urges to
      smoke after single doses of nicotine.
    

Detailed description: 
      This study will be performed at two sites and two-hundred and fifty (250) healthy male and
      female subjects will be included. Treatments comprise single doses of an experimental
      Nicotine Replacement Therapy (NRT) and Nicorette Freshfruit gum 4 mg, which are chewed during
      30 minutes. All subjects will be given both treatments in a crossover setting. The length of
      the time interval separating treatment visits, and during which no NRT must be used, will be
      at least 36 hours.

      The subjects will abstain from smoking from 8 pm the evening before until the end of each
      visit. The subjects will take the gums according to instructions from the study personnel.
      After chewing, used gums will be collected for nicotine analysis.

      Electronic diaries will be used to collect data. Urges to smoke will be scored on a 100 mm
      visual analogue scale (VAS) before the start of treatment and during 5 hours thereafter.
      Subjects will also be monitored to capture any adverse events that may occur.
    

Intervention name(s): Nicotine; Nicotine
Intervention type(s): Drug; Drug
Intervention description(s): A single 6 mg dose of an experimental Nicotine Replacement Therapy (NRT), with a 36-hour washout between visits; A single 4 mg dose of a marketed Nicotine Gum, with a 36-hour washout between visits
Other intervention name(s): Not yet marketed; Nicorette® Freshfruit gum
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Smoking Cessation; Nicotine Pharmacodynamics
Pilot Study To Assess Effect of Treatment and Adherence in PD Subjects
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the impact of imaging the brain as a diagnostic tool
      in the management of early Parkinson's disease (PD).
    

Detailed description: 
      The imaging drug used in this study is Ioflupane (123I) Injection, also referred to as
      DaTscan. DaTscan is FDA approved.
    

Intervention name(s): Group A - Early Imaging; Group B - Delayed Imaging
Intervention type(s): Radiation; Radiation
Intervention description(s): Total of 3 scans; Total of 2 scans
Other intervention name(s): [123I]-FP-CIT SPECT; [123I]-FP-CIT SPECT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Parkinsonism; Idiopathic Parkinson Disease
The Effect of Hippotherapy Applied on Different Seating Surfaces in Children With Special Needs
Condition: Special Needs Children
Study type: Interventional

Summary: 
      The effect of hippotherapy, which will be applied to children with special needs in a single
      session, on sitting balance and walking speed under the supervision of a physiotherapist was
      investigated. 30 randomly selected children with special needs between the ages of 3-18 who
      were referred to the Gebze Equestrian Training Center were included in the study. The
      children were randomly divided into 3 groups: 10 in the saddle, 10 naked (direct contact with
      the horse), and 10 in the hippotherapy group, in which a cloth of different texture was
      placed on the horse. Each group did a 30-minute hippotherapy session in the manege area.
      Before the application, the sitting balance of the children was evaluated by playing the
      Nintendo Wii Balance Platform and the Basic Balance Game. In addition, 10 m walking test was
      applied for walking speed. These assessments were repeated after the 30-minute session. It
      was checked whether the application had an effect on balance and walking speed. Comparisons
      between the groups were made and it was examined which application was more effective on
      balance and walking speed.
    


Intervention name(s): hippotherapy
Intervention type(s): Other
Intervention description(s): Evaluation parameters were applied to 30 children with special needs at the beginning of the session. After the evaluation, each group was given a 30-minute hippotherapy session in the manege area. During the practice, the child simply sat on the horse. The horse was asked to maintain its balance by adapting to the oscillations it creates while walking on the sand. Immediately after the 30-minute application, the initial evaluations were made again. As a result, it was investigated whether hippotherapy applied on different sitting surfaces in children with special needs had an effect on sitting balance and walking speed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: hippotherapy; sitting balance; child with special needs; walking speed
Bioavailability of BI 44370 TA Drinking Solution or Tablets With and Without a High Fat Meal in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this trial was to evaluate the relative oral bioavailability and
      pharmacokinetics of BI 44370 TA drinking solution (100 mg and 200 mg) and BI 44370 TA tablets
      (100 mg as two 50 mg tablets) with and without a high fat meal and to assess the safety and
      tolerability of the substances.
    


Intervention name(s): BI 44370 powder for oral solution; BI 44370 tablet; high fat breakfast
Intervention type(s): Drug; Drug; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Epidural Hydromorphone Compared With Hydromorphone Infusion in Treating Patients With Prostate Cancer Undergoing Radical Prostatectomy
Condition: Pain; Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Giving hydromorphone in different ways may relieve the pain associated with cancer
      surgery.

      PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of epidural
      hydromorphone with hydromorphone infusion in patients with prostate cancer undergoing radical
      prostatectomy.
    

Detailed description: 
      OBJECTIVES: I. Define the duration of action of hydromorphone (spinal vs supraspinal) in
      patients who have undergone radical prostatectomy. II. Demonstrate that the duration of the
      analgesic effects of equal blood concentrations of hydromorphone is dependent on the method
      used to attain this concentration by comparing continuous epidural infusion with that of a
      continuous intravenous infusion.

      OUTLINE: This is a double blinded, randomized study. After all patients have undergone
      radical prostatectomy, hydromorphone is administered in two different ways. Patients receive
      either a hydromorphone bolus injection through an epidural catheter using a patient
      controlled analgesia pump or a hydromorphone bolus injection through an intravenous catheter
      using a patient controlled analgesia pump. Infusion for both groups is stopped at 24 hours.
      Patients are followed every 30 minutes for 6 hours.

      PROJECTED ACCRUAL: A total of 40 patients will be accrued into this study over a 3 year
      period.
    

Intervention name(s): hydromorphone hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Hydromorphone
Primary purpose: Supportive Care
Keywords: prostate cancer; pain
Special Drug Use Observational Study of Xolair in Patients With Severe to Most Severe Seasonal Allergic Rhinitis Aged ≥ 12 Years and < 18 Years Whose Symptoms Were Inadequately Controlled Despite to Conventional Therapies
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Observational

Summary: 
      This was a multicenter, uncontrolled, open-label, special drug use study to investigate the
      safety and efficacy of Xolair by collecting data in its clinical setting in patients with
      severe to most severe seasonal allergic rhinitis aged ≥ 12 years and < 18 years whose
      symptoms were inadequately controlled despite to conventional therapies and used Xolair.
    

Detailed description: 
      The observation period lasted for up to 24 weeks, with Day 1 defined as the start date of
      Xolair treatment. It should be noted that, because the duration of Xolair treatment depends
      on the pollen dispersal situation and other factors, patients who completed or discontinued
      Xolair treatment before the visit at 24 weeks after the start of treatment were followed up
      until the date of last dose of Xolair + 30 days, and the results were recorded in the CRF.
    

Intervention name(s): Xolair
Intervention type(s): Drug
Intervention description(s): There was no treatment allocation. Patients administered Xolair by prescription that started before inclusion of the patient into the study were enrolled.
Other intervention name(s): Omalizumab
Intervention MeSH terms: Omalizumab
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population was patients with seasonal allergic rhinitis.
      
Keywords: Xolair; seasonal allergic rhinitis
Study to Assess Dasatinib in Patients With Core Binding Factors Acute Myelogenous Leukemia
Condition: Acute Myelogenous Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      In patients with Core Binding Factors Acute Myelogenous Leukemia, the level of Minimal
      Residual Disease after chemotherapy is predictive of relapse. The relapse risk is also
      increased in case of mutations of receptors tyrosine kinase. For patients with a high Minimal
      Residual Disease level at the end of consolidation or in molecular relapse, maintenance by
      the inhibitor dasatinib is proposed.
    


Intervention name(s): dasatinib
Intervention type(s): Drug
Intervention description(s): dasatinib 50 mg and 20 mg During one year
Intervention MeSH terms: Dasatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Core Binding Factors; Acute Myelogenous Leukemia refractory to conventional chemotherapy; molecular relapse
EMPOWER-PULM (PULMonary Outcomes in Older Adults Empowered With Movement to Prevent Obesity and Weight Regain)
Condition: Obesity; Pulmonary Disease; Dyspnea
MeSH terms: Dyspnea; Obesity
Study type: Observational

Summary: 
      The purpose of this study is to improve the understanding of the effects of weight loss on
      the lungs in older adults. Different types of tests to understand the effects of the EMPOWER
      interventions on lung function will be administered.
    

Detailed description: 
      This is a randomized clinical trial of the effects of structured aerobic exercise and a
      sedentary behavior intervention during weight loss on respiratory function. Site will enroll
      150 older (65-85 years), obese (BMI=30-45 kg/m2), sedentary men and women from EMPOWER.
      EMPOWER is a 3-group design where participants will undergo a 9-month weight loss (WL)
      intervention (6-mo intensive phase and 3-mo reduced contact phase), followed by a 9-month
      self-managed follow-up phase with minimal contact. The diet element of the interventions is
      identical across groups, but groups differ by activity intervention: 1) moderate-intensity
      aerobic exercise (WL+EX); 2) intervening on SB (WL+SitLess); or 3) (WL+EX+SitLess)
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Current participants in the parent study, EMPOWER (Empowered with Movement to Prevent
        Obesity and Weight Regain)
      
Keywords: Exercise
A Pilot Study of Rituximab for the Anticoagulation Resistant Manifestations of Antiphospholipid Syndrome
Condition: Antiphospholipid Syndrome
MeSH terms: Antiphospholipid Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      RITuximab AntiphosPholipid Syndrome (RITAPS) Study is designed to evaluate whether a
      medication called rituximab would reduce the signs and symptoms of antiphospholipid antibody
      (aPL) -related certain clinical problems.
    

Detailed description: 
      Persistently antiphospholipid antibody (aPL)-positive patients, age 18 - 75 years of age,
      with anticoagulation-resistant manifestations of APS and fulfilling protocol defined study
      inclusion criteria will receive two doses of Rituximab, and will be followed for 6 and 12
      months for clinical and safety outcomes, respectively.

      Patients are eligible to take part in this study if their blood test is persistently positive
      for aPL and they have one or more of the aPL-related clinical problem(s) listed below: low
      platelet (blood cells involved in the prevention of bleeding) count; anemia (deficiency of
      red blood cells); heart valve disease; skin ulcers; kidney smal vessel blood clots; and/or
      memory problems.
    

Intervention name(s): Rituximab
Intervention type(s): Drug
Intervention description(s): Rituximab 1000mg IV on Days 0 and 15
Other intervention name(s): Rituxan
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: antiphospholipid syndrome
Non-Interventional Study of Participants With Newly Diagnosed Schizophrenia Treated With Paliperidone Palmitate
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      The primary objective of this study is to explore hospitalization (number, length and reasons
      for psychiatric hospitalizations) in young, adult, newly diagnosed schizophrenia participants
      during the first 12 months of treatment with once monthly paliperidone palmitate in
      naturalistic clinical settings.
    

Detailed description: 
      This is a retrospective, non-interventional, multicenter study to retrospectively evaluate
      hospitalization and medical resource use, patterns of paliperidone palmitate use, and
      clinical outcomes documented within the medical records of young, adult, newly diagnosed
      schizophrenia participants for the first 12 months of continuous treatment with paliperidone
      palmitate. Only retrospective data available from clinical routine practice and documented in
      a participant's medical record will be collected. The study will be conducted in countries
      within the EMEA region in which paliperidone palmitate is approved and available. The study
      will be considered complete with the last data collection for the last participant
      participating in the study.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Participants with Schizophrenia (according to ICD 10 or DSM IV) who were recently diagnosed
        (<= 1 year [y] before start of PP treatment) with >= 18 y and <=29 y of age and who
        received PP for at least 12 months prior to study start of the study (retrospective
        cohort).
      
Keywords: Schizophrenia; Paliperidone palmitate
Safety, Tolerability, and Efficacy of AEB071 in the Treatment of Uveitis
Condition: Uveitis; Posterior Uveitis; Panuveitis
MeSH terms: Uveitis; Panuveitis; Uveitis, Posterior
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety, tolerability, and efficacy of AEB071 as a
      therapy for uveitis. Vision improvement and reduction in the swelling of retina will be
      measured for the assessment of efficacy.
    


Intervention name(s): AEB071
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Uveitis; Macular Edema
Bioequivalence Study of Aciclovir 5% Cream in Japanese Healthy Volunteers
Condition: Herpes Labialis
MeSH terms: Herpes Labialis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to show bioequivalence between Current and New formulation of
      Aciclovir cream 5% in keratin layer of the epidermis in Japanese Subjects
    


Intervention name(s): New formulation; Current formulation
Intervention type(s): Drug; Drug
Intervention description(s): New formulation of Aciclovir Cream 5% scheduled to be substituted to Current formulation in Japan; Current formulation of Aciclovir Cream 5% in Japan
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aciclovir cream 5%; Volunteer; Japanese; Male; Bioequivalence
Study to Evaluate Suppression of Ovulation and Pharmacokinetics of Medroxyprogesterone Acetate Following Administration of TV-46046 in Women With Ovulatory Cycle
Condition: Pregnancy; Contraception
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this pharmacodynamic and pharmacokinetic study is to identify a dose of
      TV-46046 (within the range 80 to 300 mg) that is both safe and consistent with contraceptive
      effect when injected every 6 months.
    


Intervention name(s): TV-46046 - 400 mg/mL; TV-46046 - 200 mg/mL
Intervention type(s): Drug; Drug
Intervention description(s): A single subcutaneous injection in the abdomen of undiluted TV-46046 - 400 mg/mL; A single subcutaneous injection in the abdomen of saline-diluted TV-46046 - 200 mg/mL
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other