bioihbjkbjnl/mcl2 huggingface dataset:
Combination of Diclofenac Potassium and Propolis in the Therapy of Oral Aphthosis
Condition: Oral Mucositis; ORAS; Oral Infection; Oral Ulcer
MeSH terms: Foot-and-Mouth Disease; Mucositis; Stomatitis; Oral Ulcer; Stomatitis, Aphthous
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The combination of diclofenac and propolis could enhance the healing of recurrent aphthous
      ulcers, instantly relieve symptoms, improve the quality of life, and present a de novo and
      cost-effective regime help in oral ulcer treatment. This study aimed to evaluate the
      influence of diclofenac and propolis combination as a gel in the treatment of recurrent oral
      ulceration
    


Intervention name(s): Combination of diclofenac potassium and propolis; placebo
Intervention type(s): Combination Product; Other
Intervention description(s): Patients will be divided into two groups: the first one will be treated with a combination of diclofenac 3% (10 mg/g, 60 g, EMS) and Propolis 5% gel and the second one is placebo group. Participants will be allocated randomly. The patients will be asked to apply gel 2 times per day. The patients will be instructed, not to eat or drink for 1 h after application of the gel; placebo
Intervention MeSH terms: Propolis; Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized clinical, double-blind, placebo-controlled study
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: diclofenac; oral disease; oral Aphthosis; propolis
IMPAACT 2015 - Evaluation of the HIV-1 Reservoir in the Central Nervous System of Perinatally-Infected Youth and Young Adults With Cognitive Impairment
Condition: HIV-1-infection
MeSH terms: Cognitive Dysfunction
Study type: Observational

Summary: 
      IMPAACT 2015 is a cross-sectional, exploratory study that will investigate the central
      nervous system (CNS) reservoir in perinatally HIV-infected adolescents and young adults on
      effective antiretroviral therapy with neurocognitive impairment. The study will assess the
      frequency with which HIV is detected in the cerebral spinal fluid (CSF) in this population
      and assess whether detectable HIV in the CSF correlates with markers of inflammation and
      neuronal injury. Findings from this study will advance understanding of the role of the CNS
      in HIV-1 persistence and its implications for future HIV-1 remission research.
    

Detailed description: 
      IMPAACT 2015 is a cross-sectional, exploratory study aiming to investigate the central
      nervous system (CNS) reservoir in perinatally HIV-infected adolescents and young adults on
      effective antiretroviral therapy with neurocognitive impairment. The study will assess the
      frequency with which HIV is detected in the cerebral spinal fluid (CSF) in this population
      and assess whether detectable HIV in the CSF correlates with markers of inflammation and
      neuronal injury. CSF will be examined for persistence of HIV-1 RNA or DNA despite
      antiretroviral therapy (ART) and for evidence of intrathecal inflammation.
      Perinatally-infected youth and young adults are of particular interest because there are very
      limited CSF data available in this population and reasons to be concerned about the CNS
      reservoir. In addition, measures of HIV-1 RNA in the CSF and associated biomarkers have not
      previously been explored in this population. A better understanding of viral persistence in
      the CSF, as well as CSF biomarker profiles, will provide preliminary data to move the field
      forward in understanding the role of the CNS in HIV-1 persistence and will have implications
      for future HIV-1 remission research.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Perinatally HIV-1-infected youth and young adults (13-24 years of age) with cognitive
        impairment, on suppressive antiretroviral therapy, from study sites in the United States
      
Biospecimen description: 
      CSF, PBMC, plasma
    
Keywords: Central Nervous System; HIV Persistence; HIV Reservoirs
Study of NP002 in Subjects With Idiopathic Parkinson's Disease to Treat Dyskinesias Due to Levodopa Therapy
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease; Dyskinesias
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study is designed to answer the question: will nicotine at doses that do not cause
      serious side effects, show feasibility in treatment of levodopa-induced dyskinesia in
      patients with Parkinson's disease?
    

Detailed description: 
      Nicotine will be employed at daily doses lower than those available OTC as smoking-cessation
      patches, in parkinsonian patients experiencing disabling dyskinesias due to their levodopa
      treatment. The principal adverse effect from this dose level of nicotine is expected to be
      nausea on acute administration to nicotine-naive patients. Because tolerance to the effects
      of nicotine is achieved by repeated dose, the study is designed to gradually escalate from 6
      to 24 mg per day, taken in 6 separate oral doses of 6 mg each. The study is designed to see
      if doses which can be tolerated by parkinsonian patients will also reduce the severity and
      frequency of the dyskinesias experienced following administration of levodopa, the gold
      standard medication for Parkinson's disease.
    

Intervention name(s): nicotine; placebo comparator
Intervention type(s): Drug; Other
Intervention description(s): Oral capsule self administered in escalating doses from 1 mg to 6 mg, 4 times a day. Each dose is is taken for two weeks, except the highest dose, which is taken for 4 weeks. At the end of 10 weeks, the dose is tapered down over 9 days. Subject is continued on study through week 14.; oral capsules containing only excipient will be self-administered with the same regimen as the active drug, 4 times a day, approximately every 6 hours for 10 weeks and nine days. Study is continued through week 14.
Other intervention name(s): NP002
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: levodopa-induced dyskinesia; Parkinson's disease; parkinsonian; levodopa-induced dyskinesias in Parkinson's disease
Human Factors Analysis in VR for Burn Treatment
Condition: Pain; Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A number of studies have shown that virtual reality (VR) can be used to distract patients
      from pain and anxiety during painful medical procedures for which medication provides
      inadequate relief. An inexpensive, commercially available VE could have significant impact in
      reducing perceived pain involved in a variety of medical procedures. The Virtual Reality
      Medical Center (VRMC) developed an engaging virtual world that proved to be effective in
      reducing reported pain ratings of participants experiencing several different forms of
      painful stimuli. The virtual world called Icy Cool World was found to successfully distract
      patients from painful stimuli and reduce patients' perceived levels of pain. Phase II looks
      to expand on these findings and examine the effectiveness as a pain distraction technique for
      a variety of acute and chronic pain etiologies. The main objective of the clinical
      investigation will be to expand on the findings from earlier studies and obtain a more
      comprehensive analysis regarding the clinical versatility of VR pain distraction.
    


Intervention name(s): Virtual Reality based distraction; VR with flat projection display; non-interactive video with head display; non-interactive video with with flat projection display
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will undergo virtual reality based distraction using the head display while they go through the pain process.; VR with flat projection display; non-interactive video with head display; non-interactive video with with flat projection display
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Partial Breast Radiation Therapy in Treating Women Undergoing Breast Conservation Therapy for Early-Stage Breast Cancer
Condition: Breast Cancer; Long-term Effects Secondary to Cancer Therapy in Adults; Skin Reactions Secondary to Radiation Therapy
MeSH terms: Breast Neoplasms; Neoplasm Metastasis
Study type: Interventional

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells.

      PURPOSE: This clinical trial is studying the side effects of partial breast radiation therapy
      and how well it works in treating women undergoing breast conservation therapy for
      early-stage breast cancer.
    

Detailed description: 
      OBJECTIVES:

        -  To allow women undergoing breast conservation therapy for early-stage breast cancer to
           have access to accelerated partial breast irradiation therapy on a controlled trial.

        -  To capture prospective data on acute and late toxicity and disease recurrence in
           patients treated with this therapy.

        -  To summarize the institutional experience of these patients treated with this
           experimental therapy.

      OUTLINE: Within 9 weeks after surgery, patients undergo accelerated partial breast
      irradiation (including conformal external-beam irradiation, interstitial brachytherapy,
      intracavitary brachytherapy, or proton beam irradiation) twice daily for 5 days (10
      fractions).

      After completion of study therapy, patients are followed every 3 to 6 months for at least 5
      years and then annually thereafter.
    

Intervention name(s): adjuvant therapy; conventional surgery; 3-dimensional conformal radiation therapy; brachytherapy; intracavitary balloon brachytherapy; proton beam radiation therapy
Intervention type(s): Procedure; Procedure; Radiation; Radiation; Radiation; Radiation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: long-term effects secondary to cancer therapy in adults; skin reactions secondary to radiation therapy; stage I breast cancer; stage II breast cancer; invasive lobular breast carcinoma with predominant in situ component; invasive lobular breast carcinoma; comedo ductal breast carcinoma; ductal breast carcinoma in situ; invasive ductal breast carcinoma; medullary ductal breast carcinoma with lymphocytic infiltrate; mucinous ductal breast carcinoma; papillary ductal breast carcinoma; tubular ductal breast carcinoma; Paget disease of the breast with intraductal carcinoma; Paget disease of the breast with invasive ductal carcinoma; breast cancer in situ
Effects of Gabapentin Versus Placebo on Buprenorphine Detoxification of Opioid-dependent Individuals
Condition: Opioid Dependence; Opioid Withdrawal; Opioid Detoxification
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study involves inducting treatment seeking opioid dependent participants onto
      buprenorphine. Once the participant reaches a stable dose they will receive either placebo or
      gabapentin to determine if gabapentin helps ease withdrawal symptoms while the participant
      undergoes a 10-day buprenorphine detoxification.
    


Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention description(s): Induction onto buprenorphine to a stable dose of 12mg/day. Then induction onto either 0 or 1600mg of gabapentin. Once the maintenance dose of gabapentin is reached a 10-day buprenorphine detoxification will begin.
Other intervention name(s): Neurontin, Suboxone,
Intervention MeSH terms: Buprenorphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: opioid dependent; detoxification; buprenorphine; suboxone; opiate
Effectiveness of Ivermectin and Doxycycline on COVID-19 Patients
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A randomized controlled trial on using Ivermectin and doxycycline to treat mild-moderate
      outpatients, severe, and critical inpatients of Coronavirus disease 19 (COVID-19) along with
      standard of care. Seventy Iraqi COVID-19 patients received Ivermectin and Doxycycline plus
      standard of care versus seventy Iraqi COVID-19 patients received standard of care only. .
    

Detailed description: 
      Objectives: COVID-19 patients suffer from the lack of curative therapy. Hence, there is an
      urgent need to try old re-purposed drugs on COVID-19. Methods: Randomized controlled study on
      70 COVID-19 patients (48 mild-moderate, 11 severe, and 11 critical patients) treated with
      200ug/kg PO of Ivermectin per day for 2 days along with 100mg PO doxycycline twice per day
      for 5-10 days plus standard therapy; the second arm is 70 COVID-19 patients (48 mild-moderate
      and 22 severe and zero critical patients) on standard therapy. The time to recovery, the
      progression of the disease, and the mortality rate were the outcome-assessing parameters.
    

Intervention name(s): Ivermectin and Doxycyline; Standard of care
Intervention type(s): Drug; Drug
Intervention description(s): Ivermectin 200ug/kg PO per day for two days, and in some patients who needed more time to recover, a third dose 200ug/kg PO per day was given 7 days after the first dose. Doxycycline 100mg capsule PO every 12h per day was given for 5-10 days, based on the clinical improvement of patients. In addition, standard care was given to the patients of Ivermectin-Doxycycline group based on the clinical condition of each patient.; Standard care
Acetaminophen 500mg on need
Vitamin C 1000mg twice/ day
Zinc 75-125 mg/day
Vitamin D3 5000IU/day
Azithromycin 250mg/day for 5 days
Oxygen therapy/ C-Pap if needed
dexamethasone 6 mg/day or methylprednisolone 40mg twice per day, if needed
Mechanical ventilation, if needed
Other intervention name(s): Stromectol and Doxycin; Control arm
Intervention MeSH terms: Ivermectin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ivermectin; Doxycycline; COVID-19; Coronavirus; SARS-CoV-2
Effect of Daily Consumption of Orange Maize on Breast Milk Retinol in Lactating Zambian Women
Condition: Vitamin A Deficiency
MeSH terms: Night Blindness; Vitamin A Deficiency
Study type: Interventional

Summary: 
      The purpose of the study is to determine whether daily consumption of beta-carotene
      biofortified maize will increase breast milk retinol concentration in lactating Zambian
      women.
    

Detailed description: 
      Lactating women were randomly assigned to one of three intervention groups to receive 6d/wk
      for 3 wk either 1) provitamin A biofortified orange maize and a corn oil capsule, 2) white
      maize and a vitamin A capsule, or 3) white maize and a corn oil capsule. The 'orange maize'
      and 'vitamin A' groups received ~600 ug RAE/d as provitamin A biofortified maize or retinyl
      palmitate, respectively. The 'white maize' group was a negative control group that did not
      receive any supplemental vitamin A.
    

Intervention name(s): white maize and a corn oil capsule; orange maize and a corn oil capsule; white maize and a vitamin A capsule
Intervention type(s): Other; Other; Other
Intervention description(s): ~ 0 ug RAE/d; ~600 ug RAE/d; 600 ug RAE/d
Other intervention name(s): beta-carotene biofortified maize; retinyl palmitate capsule
Intervention MeSH terms: Vitamin A; Beta Carotene; Retinol palmitate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Keywords: biofortification; vitamin A; maize; beta-carotene; breastmilk; Zambia
Effect of Hippotherapy and Schroth Exercise on Pulmonary Function and Aerobic Capacity in Idiopathic Scoliosis
Condition: Scoliosis Idiopathic
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      BACKGROUND: Idiopathic scoliosis has been identified as a common spinal malalignment that
      negatively impacts the respiratory system and physical conditioning in adolescents.
      Hippotherapy is an equestrian intervention that optimizes physical performance and mobility
      in a bunch of contexts; however, its influence on pulmonary function remains unclear.

      AIM: This research aimed to analyze the impact of ten weeks of hippotherapy combined with
      Schroth exercises on ventilatory function and aerobic capacity in AIS.

      DESIGN: Randomized Controlled Trial SETTING: Outpatients attend a single center that includes
      a rehabilitation room and recreational riding center.

      POPULATION: Forty-five patients were arbitrarily recruited to the experimental (N= 22) and
      control group (N=23).

      METHODS: Patients in the experimental group received 30 minutes of walking and sitting trot
      training, 15 sessions split into 2 phases over ten weeks. The two groups attended a 60-minute
      session of Schroth's intervention, 3 times/ week for 10 weeks. Two-way ANOVA for
      between-group comparisons and independent t-test for within-group comparisons were used in
      the statistical analysis.
    

Detailed description: 
      A total of 45 patients (13 males and 32 females) participated in the current study. The
      participants were assigned to one of two groups in a random manner: an experimental group who
      received hippotherapy combined with Schroth Exercise and the control group who received only
      schorth exercise. (FVC, FEV1, FEV1/FVC, MVV, and 6MWT) were measured before and after 10
      weeks intervention
    

Intervention name(s): hippotherapy and schroth exercise; schroth exercise
Intervention type(s): Other; Other
Intervention description(s): pulmonary function and aerobic capacity were measured in patients with mild idiopathic scoliosis before and after 10-week hippotherapy intervention combined with Schroth exercise; pulmonary function and aerobic capacity were measured in patients with mild idiopathic scoliosis before and after 10-week of Schroth exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Randomized Controlled Trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hippotherapy; Pulmonary Function; Idiopathic Scoliosis
A Pilot Study Of The Effects Of Microcurrent On Three Sleep Surveys
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Participants identified as having primary insomnia will be randomly assigned to groups
      receiving microcurrent stimulation or sham in a double-blind randomized controlled trial. The
      microcurrent device used is FDA approved for the treatment of insomnia.

      The hypothesis is that the experimental group will have significantly improved scores on
      three sleep surveys after treatment while the sham group will not.
    


Intervention name(s): Microcurrent; Microcurrent
Intervention type(s): Device; Device
Intervention description(s): 20 minutes of sub-threshold microcurrent 2 hours before bedtime per day for 21 days.; Participants will receive a device identical to the active device used in the experimental condition, but which produces no current.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Primary Insomnia; Microcurrent Therapy; Sleep Surveys
A Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV Lupus Nephritis
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Study type: Interventional
Phase: Phase 3

Summary: 
      This was a Phase III, randomized, double-blind, placebo-controlled, multicenter study to
      evaluate the efficacy and safety of rituximab in combination with mycophenolate mofetil (MMF)
      compared with placebo in combination with MMF in subjects diagnosed with International
      Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV lupus nephritis.
    

Detailed description: 
      In addition to receiving study drug (rituximab or placebo), participants in each treatment
      group received mycophenolate mofetil at a starting dose of 1500 mg/day IV in 3 divided doses
      and were titrated up by 500 mg/week to 3000 mg/day by Week 4, as tolerated. Participants in
      each treatment group also received methylprednisolone 1000 mg IV prior to and 3 days
      following the first study drug infusion and methylprednisolone 100 mg IV prior to the other
      study drug infusions. Participants in each treatment group also received diphenhydramine 50
      mg orally and acetaminophen 1000 mg orally 30-60 minutes prior to each study drug infusion.
      From Days 2 to 16, participants in each treatment group received prednisone 0.75 mg/kg/day
      orally (maximum dose of 60 mg) except on the day of the second methylprednisolone dose. On
      Day 16, a taper was initiated to achieve a dose of 10 mg/day by Week 16.
    

Intervention name(s): Rituximab; Placebo; Mycophenolate mofetil; Methylprednisolone; Diphenhydramine; Acetaminophen; Prednisone
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Rituximab was provided as a sterile solution for injection.; Placebo was provided as a sterile solution for injection.
Other intervention name(s): Rituxan; MabThera; Zytux; CellCept
Intervention MeSH terms: Acetaminophen; Diphenhydramine; Promethazine; Mycophenolic Acid; Prednisone; Methylprednisolone; Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Class IV LN; Lupus; LUNAR; LN