bioihbjkbjnl/mcl2 huggingface dataset:
Glutamine With Topical Corticosteroids for Lichen Planus Treatment
Condition: Lichen Penis Planus
MeSH terms: Lichen Planus
Study type: Interventional

Summary: 
      Lichen planus (LP) is an inflammatory skin disease of unknown etiology. Glutamine promotes
      protein and collagen synthesis, imparts immunity, and maintains the alimentary canal mucosa
      structure.
    

Detailed description: 
      Lichen planus (LP) is an inflammatory skin disease of unknown etiology. Recently, increased
      oxidative stress has been implicated in the pathogenesis of erosive oral lichen planus
      (EOLP). Glutamine is a source of energy for fibroblasts, immunocompetent cells, and
      intestinal epithelial cells involved in collagen production. It promotes protein and collagen
      synthesis, imparts immunity, and maintains the alimentary canal mucosa structure.

      The aim of this study is to evaluate the effect of Glutamine combined with topical
      corticosteroid in the treatment of oral erosive LP.

      Thirty patients with a confirmed clinical and histopathologic diagnosis of OLP recruited in
      this study and divided into 2 equal groups, each consisting of 15 subjects. Group 1 consists
      of patients treated with topical steroids plus antifungal (conventional therapy); Group 2
      consists of patients treated with Glutamine combined with topical steroids plus antifungal.
    

Intervention name(s): Glutamine Cap/Tab; Miconazole Oral gel; Kenacort in orabase
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Glutamine Capsules: One capsule three times daily on an empty stomach for one month; Miconazole oral gel: applied three to four times daily for three weeks; Kenacort in orabase: applied two to three times a day for 3 weeks followed by tapering the following 9 weeks until a maintenance dose of two to three times a week is reached
Intervention MeSH terms: Miconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Study to Investigate Safety, Tolerability and Effect of Multiple Dosing With AZD 4721 and/or With AZD 5069
Condition: Chronic Obstructive Pulmonary Disease (COPD).
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate safety, tolerability and effect of multiple dosing with AZD 4721 and/or
      with AZD 5069
    

Detailed description: 
      The purpose of the study is to investigate the safety and tolerability, pharmacokinetics and
      pharmacodynamics of AZD 4721 in healthy volunteers after once daily administration of
      multiple ascending doses for 10 days, and an open-label comparison with the pharmacodynamics
      of AZD5069 given twice daily for 3 days
    

Intervention name(s): AZD4721; Placebo; AZD5069
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Part A - multiple ascending dose, daily; Part B - one dose decided after part A, daily; Part A - multiple ascending dose daily; Part B - one dose decided after part A, twice a day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Healthy volunteer; Multiple ascending dose
Magnesium Sulfate as Adjuvant Analgesia and Its Effect on Opiate Use of Post-operative Transplant Patients in the Pediatric ICU
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      To use magnesium sulfate as adjuvant analgesia by implementing a treatment protocol in order
      to determine whether can benefit pediatric pain in post-operative transplanted patients and
      decrease overall opioid consumption.
    

Detailed description: 
      The post-operative ICU course for children receiving liver transplants and TPIAT (total
      pancreatectomy with islet cell autotransplantation) includes a number of different
      challenges, one of which includes pain. Pain is treated with both medications and approaches
      without medications (such as music and other distraction techniques). Opioids are one such
      effective pain medication which is universally used, however like all medications has risks
      of certain side effects (such as nausea, constipation, itching, and others). Modern research
      has searched for other medications and methods to treat pain in both children and adults. In
      this study, the investigators aim to apply one of these methods that has been shown to be
      effective in certain operative populations through a medicine called Magnesium-Sulfate, which
      may be a safe way to decrease the use of other pain medications (specifically opioids).
      Magnesium is already a physiologic electrolyte the body uses, which are consumed from certain
      foods. Used as an IV medication to reach higher levels of magnesium can work to decrease pain
      via its action on specific nerve receptors. Magnesium-Sulfate will be given at the beginning
      of transplant surgery for consented liver and TPIAT transplant patients, and continue an
      infusion for 48 hours into their ICU course. The investigators will monitor side effects and
      treat pain the same way otherwise the care team would without magnesium to determine whether
      there is any beneficial effect that can be applied to children in the future.
    

Intervention name(s): Magnesium sulfate
Intervention type(s): Drug
Intervention description(s): Magnesium sulfate (MgSO4) will be administered intravenously at induction of anesthesia as a 30-minute bolus dose of 50 mg/kg (maximum 2 grams) in the OR, followed by a 15 mg/kg/hr IV infusion for 48 hours or once the patient has transferred out of the PICU, whichever comes first.
Intervention MeSH terms: Magnesium Sulfate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of the Relative Abuse Potential of Acurox Tablets in Non-Dependent Recreational Opioid Users
Condition: Opioid Abuse
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to compare the relative abuse potential of two
      different doses of orally administered Acurox Tablets to orally administered
      immediate-release (IR) oxycodone HCl tablets in non-dependent recreational opioid users.
    

Detailed description: 
      In the tretament phase, 5 treatments administered were oxycodone HCl/niacin tablets as
      follows: (A) 40/0 mg, (B) 80/0 mg, (C) (40/240 mg, (D) 80/480 mg and (E) 0/0 mg. Each
      treatment was administered as a single dose of 8 tablets once a day at approximately the same
      time each day. All doses were given with water, and all 8 tablets were to be swallowed in 5
      minutes. Doses were separated by 48 (± 1) hours. All subjects received each treatment in a
      randomized sequence using a Williams design.
    

Intervention name(s): 40/0mg taken first; 80/0mg taken first; 40/240mg taken first; 80/480mg taken first; 0/0mg taken first
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 8x Oxycodone/Niacin 5/0mg tablets All arms taken with a 48 hour washout between doses; 8x Oxycodone/Niacin 10/0mg tablets All arms taken with a 48 hour washout between doses; 8x Oxycodone/Niacin 5/30mg tablets All arms taken with a 48 hour washout between doses; 8x Oxycodone/Niacin 10/60mg tablets All arms taken with a 48 hour washout between doses; Placebo All arms taken with a 48 hour washout between doses
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Abuse Liability; Abuse Prevention; Abuse Resistance; Abuse Deterrence
Safety, Tolerability and Clinical Activity of ASM-024 in Subjects With Mild Allergic Asthma
Condition: Mild Allergic Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will assess the safety, tolerability and clinical activity of ASM-024 in subjects
      with mild allergic asthma.
    


Intervention name(s): ASM-024; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ASM-024 50 mg of ASM-024 or 200 mg once daily by inhalation; Placebo once daily by inhalation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of a Monthly High Dose of Vitamin D3 on Bariatric Surgery Patients
Condition: Morbid Obesity; Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency; Obesity, Morbid
Study type: Interventional
Phase: Phase 1

Summary: 
      Bariatric surgery patients tend to have malabsorption of many micronutrients such as B12,
      Iron and vitamin D postoperative. So in this study, a monthly high dose of vitamin D3 is
      giving to patients with their routine supplements and followed up for 6 months.

      Hypothesis:Bariatric surgery subjects taking monthly high dose cholecalciferol supplements in
      addition to the standard vitamin D protocol will have a significant rise in serum vitamin D
      levels compared to the subjects taking only the usual vitamin D protocol.
    

Detailed description: 
      Sun exposure and supplement use questionnaire:

      A registered dietitian asked each subject for information on sun exposure, vitamins,
      medications, and any other supplement usage before each blood sample was taken.

      Lab analysis included serum hydroxy vitamin D levels pre and 3 months postoperative.

      Descriptive statistics which include both the means and standard deviations were calculated
      on the study variables. A paired sample t-test was used to determine if there was a
      significant difference in mean values pre and post vitamin D supplementation. An independent
      sample t-test was used to assess for significant differences in group (control vs. vitamin D
      supplement) means. A p-value < 0.05 was considered statistically significant. Statistical
      analyses were done using SPSS Version 21 (SPSS, Chicago, III, USA).
    

Intervention name(s): vitamin D3 (Replesta); vitamin D
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): vitamin D group receive 2 replesta tablets (100,000 IU/month) of cholecalciferol.
Other intervention name(s): Replesta
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: vitamin D; obesity; bariatric surgery
Microbiome, Exercise Tracking Study: Among Individuals at High Risk for Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study has 2 aims:

      Aim 1: To demonstrate the feasibility of recruiting and retaining adults at high risk of
      colorectal cancer to a physical activity intervention trial. Investigators hypothesize that
      it will be possible to recruit and retain this patient population to a physical activity
      intervention trial.

      Aim 2: To demonstrate the feasibility of collecting, processing, storing stool samples and
      analyzing the gut microbiome data. Investigators hypothesize that all of these steps are
      feasible.
    

Detailed description: 
      Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the U.S. and
      is the third most common cancer in men and women. CRC risk factors include genetic
      predisposition, host factors and modifiable lifestyle behaviors (e.g., diet, physical
      activity, obesity). There are very limited data on the differences in the gut microbiota
      among populations at different levels of CRC risk, as well as the effects of behavioral
      interventions to alter the gut microbiome.
    

Intervention name(s): Physical activity intervention
Intervention type(s): Behavioral
Intervention description(s): 150 minutes per week of moderate intensity cardiovascular exercise. The exercise sessions will include a minimum of 30 minutes of exercise each day, 3 to 5 times per week for a total of 150 minutes of exercise per week.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Gut Microbiota; Butyrate; Physical activity
Safety and Biomarker of OPB-111077 in Subjects With Advanced Solid Tumor
Condition: Solid Tumor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label, non-randomized trial will comprise of 2 parts. A dose escalation part will
      characterize the safety, biomarker and pharmacokinetics of OPB-111077 in advanced solid
      tumor. Subsequently, an expansion part will further evaluate the biomarker, safety,
      pharmacokinetics and antitumor activity of OPB-111077 in selected tumor types.
    

Detailed description: 
      This trial is designed to determine the safety, tolerability, maximum tolerated dose and
      recommended dose of OPB-111077 administered orally 4-days on and 3-days off (3 weeks/cycle)
      to subjects with advanced solid tumor in the dose escalation part so that biomarkers,
      efficacy, and others can be evaluated at the recommended dose in an expeditious manner in the
      expansion part. The dose escalation part employs a 3+3 escalation design as a standard dose
      escalation design for a small sample size.
    

Intervention name(s): OPB-111077
Intervention type(s): Drug
Intervention description(s): Tablet, Oral, 300mg/500mg/700mg/900mg 4 days-on & 3 days-off (21 days=1cycle)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bosentan and Pulmonary Endothelial Function
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension
Study type: Interventional

Summary: 
      6 months therapy of Bosentan, an endothelin antagonist, will lead to improvement in pulmonary
      microvascular endothelial function.
    


Intervention name(s): Bosentan
Intervention type(s): Drug
Intervention description(s): 62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months
Intervention MeSH terms: Bosentan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Specially Designed Eating Plates Effects on Food Intake in Normal Weight and Overweight Children
Condition: Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Previous studies demonstrated that children served themselves more food when using larger
      plates and bowels. The purpose of this study is to evaluate if self-served portions and
      caloric intake in normal weight and overweight children will be influenced by a specially
      designed eating plates compared to similar size normal plates.
    

Detailed description: 
      40 normal weight and 40 overweight kindergarden and elementary school children will
      participate in this study.

      Anthropometric measurements: weight, height, BMI and BMI percentiles will be measured and
      calculated for each participant.

      The participants will take part in two non-exercise activities at the 'sport and health
      center for children and adolescence'. At the end of each activity, a lunch buffet that
      contains all food ingredients will be served. During one meeting the children will be handed
      a regular plate and at the second meeting they will be handed a specially designed plate
      (with marking of the recommended meal composition and portion).

      The amount and composition of food on the plates will be assessed by weighing and photography
      before and after eating and analysed to report macronutrient consumption by a dietitian. The
      meetings for normal weight children will be separated from the overweight children.
    

Intervention name(s): Specially designed plates
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Childhood obesity; Plate; Food consumption
Study to Assess the Effect of StemAlive® Supplement on the Levels of Stem Cells in Human Volunteers
Condition: Healthy
Study type: Interventional

Summary: 
      Combination of various herbs is known to promote mobilization of hematopoietic stem cells.
      Hence the current study has been intended to study the effect of Stem Alive® on mobilization
      of stem cells. Stem Alive® include ingredients like green tea, ashwagandha, etc which are
      known to be used as traditional medicine. They are also tested qualitatively in academic and
      nutritional science research centers throughout the world and which substantially according
      to those studies stimulate the augmented availability of circulating hematopoietic cells.
      This study is projected to investigate the mobilization of stem cells on healthy human
      volunteers.
    


Intervention name(s): StemAlive®; Placebo (For StemAlive®)
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Hematopoietic stem cells; Herbal; Dietary; CD cells; Basic research
Different Modalities in Reducing Airborne Particulate Concentrations During AGP for Health Volunteers
Condition: Transmission, Patient-Professional
Study type: Interventional

Summary: 
      Several clinical procedures have been described as aerosol generating procedure (AGP),
      including nebulization, high-flow nasal cannula oxygen therapy, noninvasive ventilation, and
      bronchial hygiene treatment, etc. However, the understanding on the transmission risk of
      these treatments is still unclear, particularly the methods to reduce the airborne
      particulate concentrations during these treatments are still lacking. This study is aimed to
      compare different modalities in reducing airborne particulate concentrations during these
      aerosol generating procedures, in order to find the most effective method to reduce particle
      concentrations, ultimately to decrease the transmission risk and protect health care
      providers.
    


Intervention name(s): Filter; Scavenger face tent
Intervention type(s): Device; Device
Intervention description(s): Filter is used to capture any individual bacteria or viruses that might be suspended within inhaled or exhaled gases; A face tent is connected to a vacuum resource to continuously suction the exhaled gas from the subject, in order to reduce the transmission risk of virus or bacteria
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: aerosol generating procedure; high-flow nasal cannula; nebulization; aerosol therapy
A Study of Eribulin Mesylate With Trastuzumab for Advanced or Recurrent Human Epidermal Growth Factor Receptor 2-Positive (HER2+) Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate dose limiting toxicity (DLT), investigate the
      tolerability and safety of eribulin mesylate with trastuzumab combination therapy, and
      estimate the recommended dose.
    


Intervention name(s): E7389
Intervention type(s): Drug
Intervention description(s): Eribulin mesylate (iv) will be administered on Day 1 and Day 8 of each cycle (3 weeks as 1 cycle). Trastuzumab (iv) will be administered as weekly use or tri-weekly use. Trastuzumab will be administered immediately after eribulin mesylate administration when used concomitantly.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast Cancer
RISE: A Clinical Evaluation of the StarClose™ Vascular Closure System
Condition: Peripheral Vascular Disease; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Vascular Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease
Study type: Observational

Summary: 
      To evaluate early ambulation in patients who receive the StarClose™ VCS post-percutaneous
      diagnostic procedure.
    

Detailed description: 
      To evaluate the StarClose™ VCS in the femoral artery in subjects who are ambulated early
      post-percutaneous cardiac or peripheral vascular, diagnostic catheterization procedure. The
      clinical use of vascular closure devices for rapid hemostasis after femoral access was first
      reported in 1991. 18 participants may be ambulated almost immediately after diagnostic
      coronary angiography and discharged many hours earlier than currently practiced in most
      centers utilizing a supine restriction period of 6 hours after diagnostic catheterization.14
      After coronary interventions, participant comfort is additionally increased by immediate
      sheath removal.

      This early ambulation study is an evaluation of a clip-based technology, which achieves
      vascular hemostasis with the use of a novel extravascular Nitinol clip to provide an
      immediate mechanical closure that does not depend upon the body's clotting system. The
      procedures will be performed in participants who meet specific entrance criteria.
    

Intervention name(s): Vessel Closure (StarClose™)
Intervention type(s): Device
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects who are ambulated early post-percutaneous, cardiac or peripheral vascular,
        diagnostic catheterization procedure
      
Keywords: femoral artery; post-percutaneous cardiac catheterization; post-percutaneous peripheral vascular catheterization; post-percutaneous diagnostic catheterization; early ambulation; vascular closure
A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy
Condition: Narcolepsy
MeSH terms: Narcolepsy; Disorders of Excessive Somnolence; Sleepiness
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study to evaluate the safety and effectiveness of ADX-N05 compared to placebo in
      the treatment of excessive daytime sleepiness in adults with narcolepsy.
    


Intervention name(s): ADX-N05; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 150 mg once a day for 4 weeks followed by 300 mg once a day for 8 weeks; One capsule placebo to match ADX-N05 to be taken for 4 weeks followed by 2 capsules placebo to match ADX-N05 to be taken for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment