bioihbjkbjnl/mcl2 huggingface dataset:
A Study of New Transdermal Contraceptive Patch at End of Shelf Life and Currently Marketed EVRA at the Beginning of Shelf Life in Healthy Women
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objectives of this study are to determine the bioequivalence of the hormones
      (example, norelgestromin [NGMN] and ethinyl estradiol [EE]) from the transdermal
      contraceptive patch using the newly sourced adhesive component as compared to the currently
      marketed EVRA patch using the adhesive component, evaluate the adhesion of the transdermal
      contraceptive patch using the newly sourced adhesive component as compared to the currently
      marketed EVRA patch using the adhesive component and show non-inferior adhesion of the
      transdermal contraceptive patch using the newly sourced adhesive component as compared to the
      currently marketed EVRA patch using the adhesive component.
    


Intervention name(s): EVRA patch (NGMN+EE) (Treatment A) (Reference); High molecular weight polyisobutylene (HMW PIB) patch (NGMN+EE) (Treatment B) (Test)
Intervention type(s): Drug; Drug
Intervention description(s): A single transdermal contraceptive patch of EVRA (NGMN + EE) will be applied to the buttock (right or left) of participants on Day 1 of each Treatment period and is removed 7 days after patch application, that is, on Day 8.; A single transdermal contraceptive HMW PIB (NGMN + EE) patch will be applied to the buttock (right or left) of participants on Day 1 of each Treatment period and is removed 7 days after patch application, that is, on Day 8.
Other intervention name(s): RWJ10553
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Multi-modality MRI Study on Prediction for Mild Cognitive Impairment Conversion
Condition: Mild Cognitive Impairment; Alzheimer's Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Observational

Summary: 
      The purpose of this study is to find the characteristics of mild cognitive impairment (MCI)
      using technology of Multi-Modality MRI , including structural MRI, functional MRI and
      diffusion tensor imaging(DTI). Then analyze the difference between progressive MCI (MCIp) and
      stable MCI (MCIs) and further construct the predictable classifier from MCI to Alzheimer's
      disease (AD) based on Multi-Modality MRI characteristics of MCI patients.
    

Detailed description: 
      The cognition of MCI is between normal healthy and AD, which is thought the transitional
      stage of AD. Patients with MCI have heavy risk to convert to AD, so in this study, the
      investigators focus on the exploration of the characteristics of mild cognitive impairment
      (MCI) using technology of Multi-Modality MRI, including structural MRI, functional MRI and
      DTI. Then the investigators further study the patients who convert to AD and explore their
      MRI characteristics on baseline, in order to construct the predictable classifier from MCI to
      AD. The investigators want to achieve the early diagnosis of AD and help clinicians interfere
      with the progress of this disease.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The cognition of MCI is between healthy control and AD, which is thought the transitional
        stage of AD. Patients with MCI have heavy risk to convert to AD.
Effects of Lactobacillus Paracasei PS23 on Anti-fatigue
Condition: Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      This research is to explore the effects of supplementing Lactobacillus paracasei PS23 to
      reduce fatigue and improve physical fitness after exhaustive exercise.
    

Detailed description: 
      Studies have found that the intestinal flora of athletes is different from that of ordinary
      people, and short-chain fatty acids play a very important role. Previous animal experiments
      have found that supplementing with specific probiotics can slow down muscle loss in aging
      mice. In addition, clinical studies have found that supplementing with probiotics can improve
      sports performance by regulating the intestinal flora and related metabolites. Therefore, the
      purpose of this research is to explore the effects of supplementing Lactobacillus paracasei
      PS23 to reduce fatigue and improve physical fitness after exhaustive exercise. This study
      compares supplementary samples with placebo and adopts a double-blind study design.
    

Intervention name(s): PS23
Intervention type(s): Dietary Supplement
Intervention description(s): PS23 belongs to Lactobacillus paracasei group.Probiotic capsules contain 10 billion CFU (colony forming units) of PS23
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Effect of Exercise Training in Alzheimer's Patients
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      The objective of this study was to examine the effects of exercise training on physical
      function and biochemical markers in elderly Alzheimer's disease patients.
    

Detailed description: 
      Alzheimer's disease is a neurodegenerative disease characterized by progressive and
      irreversible degeneration of nerve cells. The loss of these cells leads to the continuous
      decline in muscle function with alterations in biochemical and haematological parameters. The
      objective of this study was to examine the effects of exercise training on physical function
      and biochemical markers in elderly Alzheimer's disease patients.
    

Intervention name(s): Physical training
Intervention type(s): Other
Intervention description(s): Physical training for three months, twice per week (60 minutes per session).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Non-pharmacological interventional study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
A Phase II Study of Imiquimod 5 % Cream for the Treatment of Hemangioma in Infancy
Condition: Hemangioma, Capillary
MeSH terms: Hemangioma; Hemangioma, Capillary; Port-Wine Stain
Study type: Interventional
Phase: Phase 2

Summary: 
      Hemangiomas of infancy, the most common benign tumors of infancy, are congenital or early
      infancy lesions characterized by a rapid postnatal growth, with high expression of angiogenic
      stimulators for 9-18 months, followed by slow regression for 5-9 years. Current therapies for
      the hemangiomas are usually restricted to more severe forms due to the risks of adverse
      effects, inconvenience and cost. Nevertheless, a substantial amount of the psychological
      discomfort and morbidity can be caused by untreated hemangiomas, especially those in the
      face.

      Recently, Imiquimod 5% cream has emerged as a safe an effective drug for several skin
      conditions that benefit from modulation of the activity of the immune system, such as common
      warts and various forms of the skin pre-cancerous and cancerous lesions. Small case reports
      series have suggest that it could also be useful in hemangiomas, possibly through the
      inhibition of the angiogenesis by local IFN production.This is a small, open label study of
      16 patients to document the efficacy of the Imiquimod 5% cream in the treatment of hemangioma
      of infancy (primary outcome). IFN and plasma drug levels, as well as clinical examinations
      and blood studies, will be carried out to evaluate safety of the treatment (secondary
      outcome). bFGF and VEGF will be measured in blood and urine in order to study the diagnostic
      and predictive value of these pro-angiogenic factors in the response of hemangiomas to the
      treatment with Imiquimod (secondary outcome).

      The study is a phase II clinical trial of a once a day application of Imiquimod 5% cream, 3
      to 7 times per week for a maximum of four months. The study held at the Dermatology Clinic of
      Sainte-Justine Hospital, and was completed within a 20 months timeframe after IRB approval.
    


Intervention name(s): Imiquimod 5% cream
Intervention type(s): Drug
Intervention description(s): Imiquimod 5% cream applied topical on hemangioma once a day , 3 to 7 times a week for a maximum of 4 months.
Other intervention name(s): Imiquimod 5% cream = Aldara; Item ID = GH-6203-0328-5, CUP-051119552409; DIN number = 02239505; Lot number -= GFK026A
Intervention MeSH terms: Imiquimod
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Infantile hemangioma; Hemangioma; Hemangioma of Infancy; benign tumors of infancy; Congenital hemangioma; Capillary
Antineoplaston Therapy in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma
Condition: Low-Grade Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      Current therapies for Low-grade Non-Hodgkin's Lymphoma provide limited benefit to the
      patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove
      beneficial in the treatment of Low-grade Non-Hodgkin's Lymphoma.

      PURPOSE: This study is being performed to determine the effects (good and bad) that
      Antineoplaston therapy has on patients with Low-grade Non-Hodgkin's Lymphoma.
    

Detailed description: 
      Low-grade Non-Hodgkin's Lymphoma patients receive gradually escalating doses of intravenous
      Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached.
      Treatment continues up to 12 months in the absence of disease progression or unacceptable
      toxicity.

      OBJECTIVES:

        -  To determine the efficacy of Antineoplaston therapy in patients with Low-grade
           Non-Hodgkin's Lymphoma, as measured by an objective response to therapy (complete
           response, partial response or stable disease).

        -  To determine the safety and tolerance of Antineoplaston therapy in patients with
           Low-grade Non-Hodgkin's Lymphoma.

        -  To determine objective response, tumor size is measured utilizing physical examination,
           radiologic studies, and bone marrow biopsies as necessary, performed every 8 weeks for
           the first two years, every 3 months for the third and fourth years, every 6 months for
           the 5th and sixth years, and annually thereafter.
    

Intervention name(s): Antineoplaston therapy (Atengenal + Astugenal)
Intervention type(s): Drug
Intervention description(s): Patients with Low-grade non-Hodgkin's lymphoma will receive Antineoplaston therapy (Atengenal + Astugenal).
The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.
Other intervention name(s): A10 (Atengenal); AS2-1 (Astugenal)ANP
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Low-grade non-Hodgkin's lymphoma
Neurectomy Vs Nerve Sparing in Open Inguinal Hernia Repair
Condition: Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      It is a randomized controlled trial in which we are treating inguinal hernia patients with
      mesh hernioplasty and either neurectomy of iliohypogastric nerve and ilioinguinal neurectomy
      or preservation comparing post operative acute or chronic pain
    


Intervention name(s): Neurectomy in inguinal hernia repair; nerve sparing in inguinal hernia repair
Intervention type(s): Procedure; Procedure
Intervention description(s): Mesh hernioplasty of inguinal hernia with neurectomy of ilioinguinal and iliohypogastric nerve; Mesh hernioplasty of inguinal hernia with sparing of ilioinguinal and iliohypogastric nerve
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Tenofovir Gel in Pregnancy and Lactation
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Tenofovir 1% gel is an investigational vaginal microbicide intended to reduce the risk of
      transmission of HIV. Pregnant women and mothers who have recently given birth often maintain
      sexual activity, and research has shown that they may be at greater risk of HIV infection
      during pregnancy. Microbicides may be able to prevent HIV infection during pregnancy, which
      would also prevent fetal exposure to HIV. This study will test the safety of using tenofovir
      1% gel in healthy, pregnant women and healthy, breastfeeding women.
    

Detailed description: 
      Microbicides are substances, like gels or foams, being developed that can be applied before
      intercourse to prevent transmission of HIV. Research has shown that pregnant women are still
      at risk of sexual transmission of HIV, and some research has suggested that pregnant women
      may be at increased risk of HIV infection. Microbicides may also aid in preventing
      mother-to-child transmission of HIV, because they might be a feasible alternative to oral or
      intravenous medications in regions where these methods are difficult to implement. In tests
      on healthy women the vaginal microbicide tenofovir 1% gel has been safe and well tolerated.
      This study will test the safety of tenofovir 1% gel in healthy, pregnant women and healthy,
      lactating women.

      Participation in this study will last approximately 3 to 10 weeks. Pregnant women will be
      followed until approximately 2 weeks after delivery of their children, and lactating women
      will be followed for 3 weeks. Pregnant women will be given either the tenofovir 1% gel or a
      placebo gel to be applied daily for 7 days. Groups of pregnant women will be further divided
      according to how late into pregnancy they enroll.

      Pregnant women will have study visits at enrollment, 6 days after enrollment, and at
      delivery. They will also participate in phone assessments 1, 3, and 14 days after enrollment
      and at delivery.

      Lactating women will be given tenofovir 1% gel and have study visits at enrollment and 6 days
      after enrollment. They will also participate in phone assessments 1, 3, and 14 days after
      enrollment.

      All participants will complete blood tests, physical exams, and assessments of adverse
      events.
    

Intervention name(s): Tenofovir 1% gel; Placebo gel
Intervention type(s): Drug; Other
Intervention description(s): One applicator of tenofovir 1% gel administered vaginally for 7 consecutive days; One applicator of placebo gel administered vaginally for 7 consecutive days
Other intervention name(s): Tenovofir disproxil fumate; TDF
Intervention MeSH terms: Tenofovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Prevention; Microbicide; Mother-to-Child-Transmission; Pregnancy
A Safety Study of VIMOVO in Adolescents With Juvenile Idiopathic Arthritis (JIA)
Condition: Juvenile Idiopathic Arthritis (JIA)
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 4

Summary: 
      A 6-month study of the safety of VIMOVO in adolescents aged 12 to 16 years with JIA.
    


Intervention name(s): VIMOVO 250/20; VIMOVO 375/20; VIMOVO 500/20
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months; 375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months; 500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
Other intervention name(s): naproxen/esomeprazole; naproxen/esomeprazole; naproxen/esomeprazole
Intervention MeSH terms: Naproxen; Esomeprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Pharmacokinetics of Kovacaine Nasal Spray in Pediatric Subjects
Condition: Anesthesia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the pharmacokinetics and safety of a nasal spray
      containing the anesthetic drug Tetracaine in combination with Oxymetazoline in healthy
      pediatric subjects.
    

Detailed description: 
      The purpose of this study is to determine the pharmacokinetics and safety of tetracaine,
      para- butylaminobenzoic acid (PBBA), and oxymetazoline after intranasal administration of the
      recommended, weight-based Phase 3 dose of Kovacaine Mist (Tetracaine Hydrochloride with
      Oxymetazoline Hydrochloride) to healthy pediatric subjects.

      Kovacaine Mist is an anesthetic solution containing 3% tetracaine hydrochloride and 0.05%
      oxymetazoline hydrochloride. A single spray dose of 100 μL Kovacaine Mist contains 3 mg
      tetracaine HCl and 0.05 mg oxymetazoline HCl. A two-100 μL spray dose (a total of 200 μL) of
      Kovacaine Mist contains 6 mg tetracaine HCl and 0.1 mg oxymetazoline HCl. A two-200 μL spray
      dose (a total of 400 μL) of Kovacaine Mist contains 12 mg tetracaine HCl and 0.2 mg
      oxymetazoline HCl.

      Kovacaine Mist will be administered based on the weight of the subject as summarized in the
      table below. Subjects weighing 10 to <20 kg will receive 1 intranasal spray of 100 μL of
      Kovacaine Mist at time D0. Subjects weighing 20 to <40 kg will receive 2 intranasal sprays of
      100 μL (total dose 200 μL) administered 4 minutes apart at times D0 and D4. Subjects weighing
      40 kg or more will receive 2 intranasal sprays of 200 μL (total dose 400 μL) administered 4
      minutes apart at times D0 and D4.
    

Intervention name(s): Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Intervention type(s): Drug
Intervention description(s): 1 spray device is 0.2mL (200 μL) in volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl. Subjects receiving the 100 μL dose will receive half of the contents of one device using a dose divider. Subjects receiving the 200 μL dose will first receive half of the contents of one device using a dose divider and then 4 minutes later will receive the 2nd half by removing the dose divider. Subjects receiving the 400 μL dose will first receive the entire contents of one device and then 4 minutes later will receive the contents of a 2nd device.
Other intervention name(s): Kovacaine Mist
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Tetracaine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetic
Aloe Vera in Chronic Periodontitis With Type 2 Diabetes Mellitus
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The present study is designed to investigate the effectiveness of AV gel local drug delivery
      as an adjunct to scaling and root planing (SRP) in the treatment of subjects with chronic
      periodontitis (CP) and type 2 diabetes mellitus (DM).
    

Detailed description: 
      BACKGROUND: Advances in the field of alternative medicine have promoted widespread use of
      herbal agents, like Aloe vera (AV), for both medical and dental therapy. AV has
      anti-inflammatory, antioxidant, antimicrobial, hypoglycaemic, healing promoting and immune
      boosting properties. The present study is designed to investigate the effectiveness of AV gel
      local drug delivery as an adjunct to scaling and root planing (SRP) in the treatment of
      subjects with chronic periodontitis (CP) and type 2 diabetes mellitus (DM).

      MATERIAL AND METHODS: A total of 60 subjects with probing depth (PD) ≥5mm and clinical
      attachment level (CAL) ≥3mm were randomly divided into two groups. Group 1 was treated with
      SRP + placebo gel local drug delivery (LDD) and Group 2 with SRP + AV gel LDD. Clinical
      parameters including full mouth plaque index (PI), modiﬁed sulcus bleeding index (mSBI),
      probing depth (PD) and clinical attachment level (CAL) were recorded first at baseline and
      then at intervals of 3 months and 6 months.
    

Intervention name(s): aloe vera; placebo gel
Intervention type(s): Drug; Drug
Intervention description(s): After SRP, aloe vera gel was delivered subgingivally into periodontal pockets.; After SRP, placebo gel was delivered subgingivally into periodontal pockets.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Thoracic Computed Tomography Scan for Diagnosis of Aspirated Foreign Bodies.
Condition: Aspirated Foreign Body of Lower Respiratory Tract
MeSH terms: Foreign Bodies
Study type: Interventional

Summary: 
      To access CT Scan as a diagnostic tool for foreign bodies aspiration.
    

Detailed description: 
      Comparison with gold standard diagnostic tool, the endoscopy
    

Intervention name(s): Thoracic CT Scan
Intervention type(s): Procedure
Intervention description(s): Perform a CT Scan and an endoscopy
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: CT Scan; Endoscopy; Aspiration; Foreign Bodies
Target Engagement for Oxytocin: Dose Ranging Study
Condition: Schizophrenia Spectrum
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      This study will evaluate the effect of 8 doses of intranasal oxytocin or placebo on two
      proposed measures of target engagement in brain. The targets are (1) the suppression of a
      particular wave form (mu) on the electroencephalogram (EEG) while subjects observe a socially
      relevant form of motion and (2) pupil dilation will subjects identify faces showing different
      emotions.
    

Detailed description: 
      Subjects with schizophrenia spectrum disorders will be randomly assigned to one of 8 doses of
      oxytocin. After screening and informed consent subjects will receive either their assigned
      dose or a placebo. Thirty minutes following the drug administration patients will be
      evaluated on the EEG and pupillometry tasks followed by two tests that evaluate social
      salience. One week later subjects will have a second challenge in the alternative (drug or
      placebo) condition.
    

Intervention name(s): Intranasal Oxytocin
Intervention type(s): Drug
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Other
Keywords: Psychosis; Schizophrenia; Oxytocin