bioihbjkbjnl/mcl2 huggingface dataset:
Tinidazole for Recurrent Bacterial Vaginosis: A Pilot Study
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This research study is being done to evaluate the use of an oral (by mouth) medication called
      tinidazole to initially treat BV and then to see if additional treatment with tinidazole
      keeps women from getting this infection back within 3 months. Tinidazole is currently
      approved by the United States Food and Drug Administration (FDA) to treat bacterial vaginosis
      (BV).

      This study will evaluate the use of tinidazole to treat a woman's current BV infection and
      then will look at using tinidazole as a suppressive treatment (taking medication regularly to
      attempt to decrease the "bad" bacteria from growing back). The suppressive treatment phase
      will include using tinidazole twice a week compared to using placebo twice a week and then
      following women for recurrence of BV. The purpose of this study is to determine if tinidazole
      suppression will prevent BV from coming back within 3 months of treatment.

      The investigators hypothesize that women with a history of recurrent bacterial vaginosis who
      are randomized to a suppressive regimen (a dose of medication given on a regular basis to
      attempt to control the bacteria that causes bacterial vaginosis) of tinidazole will have
      lower recurrence rates and a longer time to recurrence of bacterial vaginosis when compared
      to those women randomized to placebo.
    


Intervention name(s): tinidazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 gram twice weekly for 12 weeks; one pill twice weekly for 12 weeks
Other intervention name(s): Tindamax
Intervention MeSH terms: Tinidazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Bacterial Vaginosis; Recurrent Bacterial Vaginosis
Comparison of an Electronic Version of Selected COPD PRO Instruments With the Original Versions
Condition: COPD
Study type: Observational

Summary: 
      This protocol defines the requirements to demonstrate that the PRO instruments which were
      designed as paper-based are equivalent to the nSpire Health ePRO (electronic patient reported
      outcome), following the ISPOR's ePRO Good Research Practices Task Force recommendations. All
      validation studies of the questionnaires were conducted using the original paper versions.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        COPD Subjects
      
Keywords: COPD PRO Instraments equivalency
Pharmacokinetic Drug Interactions Between HGP1607 and HGP1501
Condition: Healthy Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A Randomized, Open-label, Crossover Study to Investigate the Pharmacokinetic drug
      interactions and the Safety between HGP1607 and HGP1501 in Healthy Male Volunteers
    


Intervention name(s): HGP1607; HGP1501; HGP1607+HGP1501
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Take it once per period; Take it once per period; Take it once per period
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Long-Term Follow-up of Tandem High-Dose Therapy With Peripheral Blood Stem Cell for Adults With High-Risk Age-Adjusted IPI Aggressive Non-Hodgkin's Lymphomas
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase II multicenter pilot trial (073) evaluating tandem HDT with PBSC support in aa-IPI=3
      untreated aggressive NHL.
    

Detailed description: 
      High-dose chemotherapy; untreated aggressive non-Hodgkin's lymphoma; high-risk; peripheral
      blood stem cell support Patients were aged from 15 to 60 years
    

Intervention name(s): CEEP regimen; Tandem high-dose therapy (HDT) followed by autologous peripheral blood stem cell (PBSC)
Intervention type(s): Drug; Procedure
Intervention description(s): cyclophosphamide 1200 mg/m² intravenously on day 1 (d1), epirubicin 100 mg/m² intravenously on d1, vindesine 3 mg/m² intravenously on d1 and prednisone 80 mg/m² orally or intravenously on d1-5, with two weeks intervals; The conditioning regimen of the first HDT was mitoxantrone 45 mg/m² intravenously on d1 + cytarabine 1000 mg/m² by a 3-hour infusion every 12 hours from d1-4.
The conditioning regimen of the second HDT started d30 to d45 after the first stem cell infusion, and consisted of 1200 cGy total body irradiation (TBI) in 6 twice daily 200 cGy fractionated doses with a 800 cGy pulmonary shielding, followed by CBV: carmustine 300 mg/m² intravenously on d4, etoposide 200 mg/m² intravenously on d5-8 and cyclophosphamide 1500 mg/m² intravenously on d5-8.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: High-dose chemotherapy; aggressive NHL; high-risk; PBSC
Interventions to Promote Healthy Eating and Physical Activity in Lebanese School Children Targeting Overweight and Obesity- Pilot Study
Condition: Childhood Obesity
MeSH terms: Obesity; Overweight; Pediatric Obesity
Study type: Interventional

Summary: 
      Evaluate the feasibility and effectiveness of a multi-component school-based intervention to
      promote healthy eating and physical activity with school children ages 9 to 11 years in
      Lebanon.
    


Intervention name(s): Health-E-PALS-Pilot
Intervention type(s): Other
Intervention description(s): Intervention to promote Healthy Eating and Physical Activity in Lebanese School-Children It comprises in class-activities, meetings with parents, improvement of school food service
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: School-based intervention
Efficacy/Safety Study as H. Pylori Eradication of Triple Therapy for 7 Days Treatment
Condition: Peptic Ulcer
MeSH terms: Peptic Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate of efficacy and safety as H.pylori eradiation effect
      between Ilaprazole and Pantoprazole triple therapy for 7 days treatment in Gastric and/or
      Duodenal ulcer patients with H.pylori positive infection.
    

Detailed description: 
      This study is to evaluate of efficacy and safety as H.pylori eradiation effect between
      Ilaprazole and Pantoprazole triple therapy for 7 days treatment in Gastric and/or Duodenal
      ulcer patients with H.pylori positive infection.
    

Intervention name(s): Ilaprazole; Pantoprazole
Intervention type(s): Drug; Drug
Intervention description(s): 10mg 2 BID( 2 times / day), before breakfast and dinner; 40mg, BID(2 times / day), before breakfast and dinner
Other intervention name(s): NOLTEC; PANTOLOC
Intervention MeSH terms: Pantoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of Carbon-14-Labelled [14C] LY3556050 in Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate how much of the study drug (LY3556050),
      administered as a single dose that has the radioactive substance 14C incorporated into it,
      passes from blood into urine, feces and expired air in healthy male participants. The study
      will also measure how much of the study drug gets into the bloodstream, how its broken down,
      and how long it takes the body to get rid of it. The study will last up to approximately 58
      days including the screening period.
    


Intervention name(s): [14C]-LY3556050
Intervention type(s): Drug
Intervention description(s): Administered orally
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Improving Parental Understanding of Medication Instructions Through a Pictogram-Based Intervention
Condition: Medication Errors
Study type: Interventional
Phase: Phase 1

Summary: 
      Liquid medication administration errors are common, and place children at risk for adverse
      events. Caregivers with low socioeconomic status (SES), low education and poor health
      literacy skills are at increased risk for errors. In this study, we seek to assess whether
      at-risk parents who received a plain language, pictogram-based intervention would have
      reduced medication dosing errors and improved medication adherence.
    

Detailed description: 
      Evidence suggests that errors by parents and caregivers in administering medications to their
      children are frequent. These errors, which include inaccurate dosing as well as nonadherence
      to medication regimens, place children at risk for morbidity and mortality. Misdosing is
      prevalent, with 50% or more of pediatric caregivers either measuring an incorrect dose or
      reporting a dose of liquid medication given outside the recommended range. Of further concern
      are reports of an overall poor adherence rate of 50% for pediatric medications, with
      implications for treatment failure and drug resistance.

      Few studies have examined strategies for decreasing medication administration errors in
      pediatric patients. Pictograms represent a promising approach in which simple diagrams are
      used to improve understanding of concepts. Pictorial-enhanced written materials have been
      shown to improve comprehension and adherence with medical directions, particularly for
      patients with low literacy.

      We developed a pictogram-based intervention to decrease dosing errors and improve adherence.
      In this study, we sought to assess whether this intervention would reduce medication dosing
      errors and improve adherence in a pediatric emergency room serving at-risk families.
    

Intervention name(s): Pictogram
Intervention type(s): Other
Intervention description(s): The plain language, pictogram-based medication instruction sheets (available in English and Spanish) utilize pictograms to convey information about the medication name, indication, dose, dose frequency, and length of treatment, along with information about preparation and storage. The sheets also include a medication log for parents to keep track of when they administer the medication.
Research staff reference the sheets as they demonstrate dosing with a standardized dosing instrument; teachback is performed to reinforce concepts. For medications in which a standardized dosing instrument was not included at dispensing, a standardized oral dosing syringe is provided for the caregiver to use at home. After counseling, the caregiver is given the instruction sheet to take home.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Medication errors; Patient nonadherence; Literacy; Communication
Bed-rest, Muscle Mass and Insulin Sensitivity
Condition: Disuse Atrophy
MeSH terms: Muscular Disorders, Atrophic; Insulin Resistance
Study type: Interventional

Summary: 
      In the present study, the effects of 7 days of bed rest on muscle mass, muscle fiber
      characteristics and insulin sensitivity will be determined.
    


Intervention name(s): Bed rest
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Efficacy of an Extract of Concentrated Korean Red Ginseng for Preventing Upper Respiratory Tract Infections
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Upper respiratory tract infections are a major source of morbidity throughout the world.
      Extracts of Korean red ginseng have been found to have the potential to modulate both natural
      and acquired immune responses. The investigators sought to examine the efficacy of an extract
      of Korean red ginseng in preventing colds. Therefore, the efficacy and safety of Korean red
      ginseng will be investigated in healthy subjects during the influenza season.
    

Detailed description: 
      The extract of Korean red ginseng has been found efficacious in the prevention of respiratory
      infections in healthy adults. The investigators will be conducted a randomized, double-blind,
      placebo-controlled study at the onset of the influenza season. A total of 100 subjects 30-70
      years of age with a history of at least 2 colds in the previous year will be recruited from
      the general population in jeollabuk-do, South Korea. The subjects will be instructed to take
      9 capsules per day of either the Korean red ginseng extract or a placebo for a period of
      12weeks. The primary outcome measure will be the number of Jackson-verified colds. Secondary
      outcome measures will be included symptom severity, total number of days of symptoms and
      duration of all colds. Cold symptoms will be scored by subjects.
    

Intervention name(s): Korean red ginseng; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Korean red ginseng(3.0g/day) for 12 weeks; Placebo (3.0g/day) for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Comparison of Nutritional Products for People With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      Part A: To compare the glucose and insulin responses of a standard tube feeding product to
      that of a diabetes-specific tube feeding product in individuals with type 2 diabetes.

      Part B: To compare the glucose response of a standard tube feeding product to that of a
      diabetes-specific tube feeding product when consumed by individuals with type 2 diabetes as a
      sole source of nutrition.
    


Intervention name(s): enteral nutritional formula; Diabetes specific enteral product
Intervention type(s): Other; Other
Intervention description(s): Meal glucose tolerance test; Meal Glucose tolerance test
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Auricular Acupuncture for Primary Insomnia
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      This double-blind RCT will evaluate the therapeutic effectiveness and safety of auricular
      acupuncture(AA) for primary insomnia(PI) .
    

Detailed description: 
      Investigators will conduct a 2-year clinical trial on auricular acupuncture (AA) for primary
      insomnia (PI), which is a double-blind (patient-blind and assessor-blind) RCT. 288 patients
      will be randomly assigned into 2 groups: the treatment group (Group A) and the control group
      (Group B). Group A will be treated with AA plus oral Eszopiclone, while Group B will be
      treated with sham AA plus oral Eszopiclone. All patients will receive a continuous 4-week
      treatment and 28-week follow-up. The data will be analyzed by the third party who is not
      clear about allocation and treatment.
    

Intervention name(s): auricular acupuncture(AA); placebo AA; Eszopiclone
Intervention type(s): Other; Other; Drug
Intervention description(s): Auricular acupoints: Shenmen (TF4), Heart (CO15), Subcortex (AT4), modifying points according to different patterns.
Auricular attachment material: disposable Seirin Pyonex Needle Seirin Pyonex Needle manufacturer: Seirin Corporation, a Japanese company. Medical Device Certification number: No. 15500BZZ00806000.
Treatment frequency: every 3 days.
Duration: 4 weeks.; Auricular acupoints: Wrist (SF1), Clavicle (SF6), Shoulder (SF4、5), Tooth (LO1), Tonsil (LO7, 8, 9).
Auricular attachment material: the disposable Pyonex Zero Needle Pyonex Zero Needle manufacturer: Seirin Corporation, a Japanese company.
Treatment frequency: every 3 days.
Duration: 4 weeks.; Dosage form: tablet.
Dosage: 1 piece (3mg).
Drug manufacturer: Kanghong pharmaceutical limited liability company, Chengdu.
Production license: NO. H20100074 approved by the state.
Treatment frequency: 15 mins before going to bed everyday.
Duration: 4 weeks.
Other intervention name(s): Lunesta or Estorra
Intervention MeSH terms: Eszopiclone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: primary insomnia; auricular acupuncture
Evaluation of Novel Lung Function Parameters in Patients With Pulmonary Hypertension (PH)
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Observational

Summary: 
      Little is known about affection of small airways in patients with pulmonary hypertension as
      well as the ideal diagnostic approach. The investigators therefore aimed to evaluate novel or
      not widely used lung function tests for the evaluation of airway function in patients with
      PH.
    


Intervention name(s): body plethysmography; impulse oscillometry; multiple breath washout
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): measurement of conventional lung function parameters; measurement of central and peripheral airway resistance; measurement of ventilation heterogeneity
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        PH group: known or first diagnosis of PH

        Healthy controls: normal lung function testing including whole-body plethysmography and
        transfer factor, no previously diagnosed pulmonary disease as well as no respiratory
        symptoms.

        Non-healthy controls: stable pulmonary comorbidities including COPD, sarcoidosis, asthma,
        or fibrosis as well as non-pulmonary comorbidities.
Efficacy and Safety of Mometasone Furoate Nasal Spray in Children With Adenoid Hypertrophy. SNORE Study (P05155)
Condition: Adenoids Hypertrophy
MeSH terms: Hypertrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether 8 weeks treatment with mometasone furoate
      nasal spray (MFNS), twice daily, is safe and effective in treating adenoid hypertrophy in
      children.
    


Intervention name(s): Mometasone Furoate nasal spray; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Mometasone Furoate nasal spray 1 puff (50 mcg) per nostril twice daily x 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).; Placebo nasal spray 1 puff per nostril twice daily x 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
Other intervention name(s): SCH 032088
Intervention MeSH terms: Mometasone Furoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Efficacy and Safety of Desmopressin (Nocturin®) 0.1 mg Tablets in Treatment of Nocturia in Participants With Benign Prostate Syndrome (BPS)
Condition: Nocturia Associated With Nocturnal Polyuria
MeSH terms: Polyuria; Nocturia
Study type: Observational

Summary: 
      Documentation of the efficacy and safety of desmopressin (Nocturin®) 0.1 mg tablet.
      Observation of patients with benign prostate syndrome, in whom nocturia associated with
      nocturnal polyuria is treated with desmopressin (Nocturin®) 0.1 mg tablet focusing on number
      of nocturnal voids, ratio of night/24-h urine volume (%), duration of first undisturbed sleep
      period and quality of life.
    


Intervention name(s): desmopressin
Intervention type(s): Drug
Intervention description(s): desmopressin (Nocturin®) 0.1 mg tablet per day for 12 weeks
Other intervention name(s): Nocturin®
Intervention MeSH terms: Deamino Arginine Vasopressin
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        private practices
MenABCWY Noninferiority Study in Healthy Participants ≥10 to <26 Years of Age
Condition: Meningococcal Vaccine
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to determine the immunologic noninferiority of MenABCWY to licensed
      vaccines Trumenba and MenACWY-CRM (Menveo) by assessing the safety and immunogenicity of
      MenABCWY and the comparators in both ACWY-naïve and ACWY-experienced healthy participants ≥10
      to <26 years of age.
    


Intervention name(s): MenABCWY; Saline; Trumenba; MenACWY-CRM
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): N meningitidis groups A, B, C, W, and Y vaccine; Placebo; Bivalent recombinant lipoprotein 2086 vaccine; Meningococcal group A, C, W-135, and Y conjugate vaccine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Does Adding Lidocaine to Corticosteroid Injections Reduce Pain Intensity in Hand Surgery
Condition: Hand Osteoarthritis; Trigger Finger; Carpal Tunnel Syndrome
MeSH terms: Trigger Finger Disorder; Carpal Tunnel Syndrome; Pain
Study type: Interventional

Summary: 
      The purpose of this study was to determine whether adding Lidocaine to Corticosteroid
      injections reduce pain intensity in hand surgery.
    

Detailed description: 
      There is a lack of evidence about the use of lidocaine injection as an addition to steroids
      against pain during injections. Adding lidocaine adds to the volume of the injection, which
      might increase pain. It's possible that injecting cortisone without any lidocaine would be
      more comfortable than with lidocaine.

      The aim of this randomized controlled trial is to assess the difference in pain intensity
      (during the injection and 4 hours later) between patients receiving a corticosteroid
      injection with or without lidocaine in patients with a hand condition. Secondarily, the aim
      of this study is to assess factors independently associated with pain intensity, satisfaction
      with the visit, and perceived empathy.
    

Intervention name(s): Lidocaine; Corticoids
Intervention type(s): Drug; Drug
Intervention description(s): The group with the lidocaine will get a combined injection with a corticosteroid and lidocaine. The dosages depend on the disease.; The group without the lidocaine will get an injection with only corticosteroids. The corticosteroid dosage depends on the disease and will be the same as for the group with the lidocaine:
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomized in two groups for the corticosteroid injection, one group with lidocaine and one group without lidocaine.
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment