bioihbjkbjnl/mcl2 huggingface dataset:
Traumeel® S in Preventing and Treating Mucositis in Young Patients Undergoing Stem Cell Transplantation
Condition: Kidney Cancer; Leukemia; Lymphoma; Neuroblastoma; Oral Complications; Sarcoma
MeSH terms: Lymphoma; Leukemia; Neuroblastoma; Kidney Neoplasms; Mucositis
Study type: Interventional

Summary: 
      RATIONALE: Traumeel® S (a mouth rinse) may be effective in preventing or decreasing the
      severity of oral mucositis caused by chemotherapy in young patients who are undergoing stem
      cell transplantation.

      PURPOSE: This randomized clinical trial is studying how well Traumeel® S works in preventing
      or treating mucositis in young patients who are receiving chemotherapy with or without
      total-body irradiation before undergoing stem cell transplantation.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the efficacy of Traumeel® S vs placebo in reducing the severity and duration of
           chemotherapy-induced (with or without total body irradiation) mucositis in pediatric
           patients undergoing hematopoietic stem cell transplantation.

        -  Determine the safety of this drug in these patients.

      OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
      are stratified according to treatment with total body irradiation during conditioning
      chemotherapy (yes vs no), type of transplantation (autologous vs allogeneic), and
      participating institution (COG vs foreign). Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive oral Traumeel® S mouth rinse 5 times daily beginning on day -1
           before transplantation.

        -  Arm II: Patients receive oral placebo mouth rinse 5 times daily beginning on day -1
           before transplantation.

      In both arms, treatment continues until day 20 post-transplantation OR until mucositis
      resolves to Walsh score ≤ 1 for 2 consecutive days.

      Patients are followed until day 100 post-transplantation.

      PROJECTED ACCRUAL: A total of 180 patients (90 per treatment arm) will be accrued for this
      study within 2 years.
    

Intervention name(s): Traumeel S; Placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Supportive Care
Keywords: oral complications; disseminated neuroblastoma; previously treated childhood rhabdomyosarcoma; recurrent Wilms tumor and other childhood kidney tumors; recurrent/refractory childhood Hodgkin lymphoma; recurrent childhood acute lymphoblastic leukemia; recurrent childhood acute myeloid leukemia; recurrent childhood large cell lymphoma; recurrent childhood lymphoblastic lymphoma; recurrent childhood rhabdomyosarcoma; recurrent childhood small noncleaved cell lymphoma; untreated childhood acute lymphoblastic leukemia; untreated childhood acute myeloid leukemia and other myeloid malignancies; childhood acute lymphoblastic leukemia in remission; childhood acute myeloid leukemia in remission; childhood chronic myelogenous leukemia; juvenile myelomonocytic leukemia; recurrent neuroblastoma
Efficacy and Long-Term Safety of Ragweed (Ambrosia Artemisiifolia) Sublingual Tablet in Adults With a History of Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (Study P05233)(COMPLETED)
Condition: Rhinitis; Allergic, With Asthma; Conjunctivitis
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic; Conjunctivitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will evaluate the efficacy and safety of ragweed sublingual tablet (SCH
      39641/MK-3641) compared with placebo in participants with ragweed-induced rhinoconjunctivitis
      over a one-year period. It is expected that ragweed allergic participants on one of the
      active arms of the trial will have decreased allergic rhinoconjunctivitis symptoms and
      require less allergy rescue medications during ragweed pollen season.
    


Intervention name(s): SCH 39641 6 Amb a 1-U; SCH 39641 12 Amb a 1-U; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): SCH 39641 6 Amb a 1-U sublingual tablets administered once daily; SCH 39641 12 Amb a 1-U sublingual tablets administered once daily; matching placebo sublingual tablets administered once daily
Other intervention name(s): MK-3641; MK-3641
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Sevoflurane Versus Desflurane for Catheter-related Bladder Discomfort
Condition: Catheter Site Discomfort; Complications; Anesthesia; Urinary Bladder Neoplasms
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional

Summary: 
      We want to evaluate the efficacy of the sevoflurane and desflurane for the prevention of
      catheter-related bladder discomfort.
    

Detailed description: 
      The mechanism of catheter-related bladder discomfort is thought to be related to the
      muscarinic receptor. The volatile anesthetics such as sevoflurane and desflurane are known to
      block the muscarinic receptor in different ways.

      We want to evaluate the efficacy of the sevoflurane and desflurane for the prevention of
      catheter-related bladder discomfort.
    

Intervention name(s): Sevoflurane; Desflurane
Intervention type(s): Drug; Drug
Intervention description(s): Sevoflurane will be used.; Desflurane will be used
Intervention MeSH terms: Sevoflurane; Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Functional Dyspepsia
Condition: Functional Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional

Summary: 
      Objective: To observe the effect of the treatment of transcutaneous auricular vagus nerve
      stimulation (taVNS) for the functional dyspepsia (FD).

      Methods: We accrued 94 patients at Beijing TongRen Hospital. All treatments were
      self-administered by the patients at home after training at the hospital. Patients completed
      questionnaires at baseline and after 4 weeks, 8 weeks, 12 weeks. The FD Symptoms Index,
      Functional Dyspepsia Quality of Life Scale (FDDQL), Hamilton Anxiety Scale (HAMA), Hamilton
      Depression Scale (HAMD), and Self-Depression Rating Scale (SDS) were performed to evaluate
      the therapeutic effects.

      A difference of P < 0.05 was considered statistically significant.
    


Intervention name(s): taVNS; tnVNS
Intervention type(s): Device; Device
Intervention description(s): taVNS was applied using a Huatuo stimulator (SDZ-IIB) developed by Suzhou manufacture of Medical Device and Material. Stimulation parameters was 1 mA of electrical current at a frequency of 30 Hz with pulse duration ≤ 1 ms, for 30min, administered twice daily.
The two electrodes were placed on the cymba conchae and concha around the left ear.; tnVNS was applied using a Huatuo stimulator (SDZ-IIB) developed by Suzhou manufacture of Medical Device and Material. Stimulation parameters was 1 mA of electrical current at a frequency of 30 Hz with pulse duration ≤ 1 ms, for 30min, administered twice daily.
The two electrodes were placed on the antihelix around the left ear.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: transcutaneous auricular vagus nerve stimulation
Dose-Ranging Trial of Safety & Immunogenicity of an Oral Adenoviral-Vector Based RSV Vaccine (VXA-RSV-f)
Condition: Respiratory Syncytial Virus (RSV)
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Determine the
      Safety and Immunogenicity of an Adenoviral-Vector Based Respiratory Syncytial Virus (RSV) F
      Protein Vaccine (VXA-RSV-f) Expressing Protein F and dsRNA Adjuvant Administered Orally to
      Healthy Volunteers
    

Detailed description: 
      The study will enroll 66 subjects in four cohorts. All subjects will receive a single
      administration of VXA-RSV-f at a low dose, a high dose or placebo.

      Two sentinel groups will enroll 3 subjects each in an open-label manner (Cohorts 1 and 3) to
      receive VXA-RSV-f prior to enrolling either of the randomized, controlled cohorts (Cohorts 2
      and 4). Within the double-blinded Cohorts (2 and 4), placebo subjects will receive the same
      number of tablets as the vaccine subjects in that Cohort. Subjects will be enrolled and dosed
      in the low dose groups prior to initiation of dosing in the high dose group.

      Cohort 1: 3 subjects at low dose Cohort 2: 20 subjects at low dose and 10 placebo Cohort 3: 3
      subjects at high dose Cohort 4: 20 subjects at low dose and 10 placebo

      Subjects will be followed for 28 days post vaccination for preliminary immunogenicity.
      Subjects will continue to be followed for 1 year post-vaccination for long term safety.
    

Intervention name(s): VXA-RSV-f Tablets (high dose); VXA Placebo Tablets; VXA-RSV-f Tablets (low dose)
Intervention type(s): Biological; Other; Biological
Intervention description(s): The drug product will be provided as small white enteric-coated tablets. Multiple tablets may be administered to delivered the high dose.; The placebo will be provided as small white enteric-coated tablets that are similar in size and number to the active drug product tablets.; The drug product will be provided as small white enteric-coated tablets. Multiple tablets may be administered to delivered the low dose
Other intervention name(s): RSV (high dose) Oral Vaccine Tablet; Placebo Control; RSV (low dose) Oral Vaccine Tablet
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Safety and Adherence of a Non-medicated Intravaginal Ring (IVR)
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety of and adherence to a non-medicated IVR
      in HIV uninfected women over 12 weeks of use.
    

Detailed description: 
      Women comprise a growing proportion of new HIV infections worldwide. Intravaginal rings
      (IVRs) used to deliver microbicides have the potential to significantly reduce the
      heterosexual transmission of HIV if found to be safe, acceptable, and effective against HIV
      infection. This study will investigate the safety and acceptability of a non-medicated
      silicone elastomer IVR in sexually active HIV uninfected women.

      The expected duration of this study for each participant is 16 weeks. Study participants will
      be randomly assigned to one of two arms. Participants in Group A will insert an IVR into
      their vagina at study entry. The IVR will remain in place for 12 weeks until removed by a
      physician. Follow up will continue for an additional 4 weeks after IVR removal. Participants
      in Group B will not receive an IVR, but will follow the same study schedule as those in Group
      A.
    

Intervention name(s): Non-medicated Intravaginal Ring
Intervention type(s): Drug
Intervention description(s): Cured silicone elastomer composed of an elastomer base, normal propylorthosilicate, and titanium dioxide. The ring will not contain an active pharmaceutical ingredient.
Other intervention name(s): Placebo Intravaginal Ring
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Placebo IVR as a delivery method
Simvastatin in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Using Avonex Compared to Placebo
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Patient with relapsing remitting multiple sclerosis taking avonex are included in this double
      blind randomized control trial. Simvastatin is compared to placebo. end points of edss ,
      total attack, new enhancing lesion and newt2 lesion in mri is evaluated as end point.
    


Intervention name(s): simvastatin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40 mg/ day; 80 mg /day
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: edss attack
Repetitive Transcranial Stimulation (rTMS) in Post Stroke Dysphagia
Condition: Dysphagia; Stroke
MeSH terms: Deglutition Disorders; Stroke
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to assess if rTMS on healthy hemisphere at one hertz could improve
      patients with post stroke dysphagia.
    


Intervention name(s): rTMS; Placebo rTMS
Intervention type(s): Device; Device
Intervention description(s): effective and active cortical magnetic stimulations; non active cortical magnetic stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: repetitive transcranial stimulation
A Phase 1, Bioequivalence Study of SYR-472 25mg and 50mg Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the bioequivalence of 2 tablets of SYR-472 25
      milligram (mg) and 1 tablet of SYR-472 50 mg administered to healthy adult males.
    

Detailed description: 
      Bioequivalence of 2 SYR-472 25 mg tablets and 1 SYR-472 50 mg tablet administered to healthy
      adult males will be investigated in a randomized, open-label, crossover study.
    

Intervention name(s): SYR-472
Intervention type(s): Drug
Intervention description(s): SYR-472 25mg, 50mg
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Ramelteon on Transient Insomnia in Healthy Adults
Condition: Transient Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of Ramelteon, once daily
      (QD), in healthy subjects within a sleep lab.
    

Detailed description: 
      Insomnia is characterized by difficulties initiating and maintaining sleep, or of
      non-restorative and non-refreshing sleep. Transient insomnia affects approximately one-third
      to one-half of the US population, based on the results of 2 surveys of representative samples
      of the adult US population conducted by the Gallup Organization in which respondents were
      asked if they had "ever had difficulty sleeping." Based on reports of "regular" or "frequent"
      sleep difficulty, results from the same studies suggest that approximately one-tenth of the
      US population experiences chronic insomnia. The ideal treatment for insomnia would reduce the
      latency to onset of sleep and increase total sleep time, without a negative impact on sleep
      architecture and without safety concerns or next-day effects.

      Ramelteon is a selective melatonin-1 receptor agonist under global development by Takeda
      Chemical Industries, Ltd., for the treatment of transient and chronic insomnia and for the
      treatment of Circadian Rhythm Sleep Disorders.

      This study is being conducted to evaluate the safety and efficacy of a single dose of
      Ramelteon in normal healthy subjects in a sleep lab model of transient insomnia.
      Participation is this study is anticipated to be about 3 weeks.
    

Intervention name(s): Ramelteon; Ramelteon; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ramelteon 8 mg, tablets, orally for one night only.; Ramelteon 16 mg, tablets, orally for one night only; Ramelteon placebo-matching tablets, orally for one night only
Other intervention name(s): Rozerem™; TAK-375; Rozerem™; TAK-375
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Insomnia; Sleep Disorder; Drug Therapy
Theta Burst Brain Stimulation in Diabetic Neuropathy Patients With Neuropathic Pain: Investigating Neural Mechanisms
Condition: Diabetic Neuropathy, Painful
MeSH terms: Neuralgia; Diabetic Neuropathies
Study type: Interventional

Summary: 
      The purpose of the study is to determine the effects of a newer form of non-invasive brain
      stimulation (called transcranial magnetic stimulation or TMS) as a treatment in patients with
      painful diabetic neuropathy to examine its effects on their understanding of their pain
      experience.
    

Detailed description: 
      The proposed brain stimulation technique in this study is an investigational procedure that
      has not been approved by the U.S. FDA for treating pain linked to diabetic neuropathy, but it
      has been approved to treat depression. The study will use surveys to monitor how
      participant's body changes as their understanding of their pain experience changes.
      Participants will be randomized (like the flip of a coin) to receive brain stimulation at one
      of two brain regions which are involved in the processing and understanding of the pain
      experience.
    

Intervention name(s): Prolonged continuous theta burst stimulation (pcTBS)
Intervention type(s): Procedure
Intervention description(s): Non-invasive brain stimulation (transcranial magnetic stimulation or TMS) which consists of a stimulating coil being held over the head. When this coil delivers a painless magnetic pulse, it feels like a quick, light tap on the head. Two different coils will be used to perform TMS. One coil will be used to determine stimulation parameters for the pcTBS protocol. The second coil will be used to implement pcTBS, which is a repetitive non-invasive brain stimulation protocol which feels like many quick, light taps on the head. Participants will receive two procedures during one session, one with active stimulation and one with inactive stimulation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: transcranial magnetic stimulation; non-invasive brain stimulation
Estimating Prevalence of COVID-19 Infection and SARS-CoV-2 Antibodies in MS Patients
Condition: Multiple Sclerosis; Covid19
MeSH terms: COVID-19; Multiple Sclerosis
Study type: Observational

Summary: 
      This non-interventional, biospecimen collection study is designed to help us better
      understand whether MS patients have impaired immune defenses to COVID-19 infection. The
      potential influence of immune modulating medications for MS will be considered through these
      exploratory studies. This study is also designed to provide context for interpretation of
      anti-SARS CoV2 serologies in MS patients during convalescence from COVID-19 infection.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Projected study size is 1000 MS patients for primary objective and additional 40
        non-autoimmune COVID-19 convalescent control and 20 COVID-19 negative healthy controls.
      
Biospecimen description: 
      Blood samples will be obtained from participants.
    
Keywords: Disease-Modifying Therapy
Enteral Administration of Docosahexaenoic Acid to Prevent Necrotizing Enterocolitis in Preterm Neonates
Condition: Necrotizing Enterocolitis
MeSH terms: Enterocolitis; Enterocolitis, Necrotizing
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      -  The purpose of this study is to determine whether docosahexaenoic acid is effective in
           the prevention or reducing severity of necrotizing enterocolitis (NEC) in preterm
           neonates < 1500 g at birth who are starting enteral feeding.

        -  if NEC is prevented, this study will measure whether hospital stay is also reduced in
           neonates who receive Docosahexaenoic acid (DHA)
    

Detailed description: 
      -  Preterm neonates with birth weight less than 1500 g are in higher risk to develop NEC.

        -  NEC is an inflammatory condition that:

             1. Is the medical urgency most frequent of gastrointestinal tube that requires
                neonatal intensive care

             2. may perforate infant´s bowel requiring surgery from 20% to 60% of the cases

             3. may cause infant's death in 20% to 42% of the cases.

             4. has no adequate treatment worldwide, therefore prevention is needed

        -  DHA by enteral feeding has been administrated by our research group to attenuate
           inflammatory response in septic and surgical neonates.

        -  Our results showed:

             1. lower Interleukin(IL)-1 beta in septic neonates, but in surgical neonates, they
                also showed less IL-6 and anti-inflammatory cytokines IL-10 and IL-1ra, after
                adjusting by confounders

             2. increased weight, length and fat mass gain in septic neonates

             3. decreased organic failures in surgical neonates, and

             4. lower stay at neonatal intensive care in surgical neonates

      DHA has not been used as unique intervention at a high but physiological dose; in addition,
      our previous results found an anti-inflammatory effect in neonates.Therefore, we expect that
      preterm infants may have a reduced bowel inflammatory response and lower NEC events and or
      severity
    

Intervention name(s): Docosahexaenoic acid (DHA); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Docosahexaenoic acid from algae source; Placebo was designed to mimic the color and consistence of the oil that contains DHA
Other intervention name(s): n-3 Fatty Acids; Sunflower oil, Placebo for DHA intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The intervention was the docosahexaenoic acid, a nutraceutical derived from the omega 3 fatty acids.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: docosahexaenoic acid; n-3 fatty acids; necrotizing enterocolitis; preterm infants