bioihbjkbjnl/mcl2 huggingface dataset:
Methodology Study of Novel Outcome Measures to Assess Progression of ALS
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Observational

Summary: 
      The primary objectives of the study are to estimate and rank-order the longitudinal
      standardized mean changes over 6 months and over 12 months, for a set of outcome measures
      administered to participants with amyotrophic lateral sclerosis (ALS), in order to identify
      measures that are more sensitive to disease progression than Amyotrophic Lateral Sclerosis
      Functional Rating Scale-Revised (ALSFRS-R). The secondary objectives of this study are: To
      evaluate the test-retest reproducibility of each outcome measure; To determine correlations
      between 6 and 12-month changes in all exploratory measures with 18 and 24-month changes in
      ALSFRS-R and survival; To assess correlations between/among the various measures; To obtain
      biological samples in order to identify molecular correlates to the clinical measures and to
      further characterize previously identified and novel molecular biomarkers of disease
      progression for incorporation into future clinical studies.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants suffering from ALS are recruited by participating physicians in a standard
        clinical practice setting.
Omega-3 Fatty Acids in Autism Spectrum Disorders
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a 12-week open label trial to evaluate whether omega-3 fatty acids is effective in
      reducing the severity of autism and its comorbidities.
    


Intervention name(s): Omega-3 fatty acids
Intervention type(s): Dietary Supplement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Anemia and Inflammation
Condition: Iron Deficiency Anemia; Inflammation
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Inflammation
Study type: Observational

Summary: 
      During inflammation hepcidin concentrations are increased, leading to a decrease in iron
      absorption. In iron deficiency anemia hepcidin is suppressed due to the activation of
      erythropoiesis. Whether inflammation or anemia has the stronger effect on hepcidin is
      uncertain.
    


Intervention name(s): Dultavax and Vaxigrip
Intervention type(s): Biological
Intervention description(s): All the women got an influenza/DTP vaccine in order to induce acute inflammation
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Young women with or without iron-deficiency anemia
      
Biospecimen description: 
      Serum Samples
A Study to Assess the Effect of Rifampin on the Pharmacokinetics of PCI-32765 in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the potential effects of rifampin on the
      pharmacokinetics (how the drug concentrations change over time) of PCI-32765 in healthy
      participants.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), single center
      (study conducted at one site), sequential study (it is a design in a single group of
      participants are administered one or more study medication in a sequence) to evaluate the
      potential effects of rifampin on the pharmacokinetics of PCI-32765 in healthy
      participants.The study consists of 3 phases: screening phase (21 days prior to first dose of
      study medication), treatment phase (14 days), and a follow up phase (10 to 12 days after the
      last dose of study medication). In the treatment phase, a single dose of PCI-32765 560 mg
      will be administered orally on Day 1 and Day 11. Rifampin 600 mg (2 X 300 mg) will be
      administered orally on Days 4 to 13; followed by a single dose of PCI-32765 on Day 11. Follow
      up will be continued until Day 14. Safety evaluations for adverse events, clinical laboratory
      tests, electrocardiogram, vital signs, and physical examination will be monitored throughout
      the study. The duration of the study will be approximately for 45 days.
    

Intervention name(s): PCI-32765; Rifampin
Intervention type(s): Drug; Drug
Intervention description(s): PCI-32765 will be administered as a single oral dose of PCI-32765 560 mg on Day 1 and Day 11; Rifampin 600 mg (2 X 300 mg) daily dose will be administered orally from Day 4 to Day 13 and on Day 11 along with PCI-32765.
Intervention MeSH terms: Rifampin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy participants; PCI-32765; Rifampin; PCI-45227; CYP3A4
A Clinical Trial to Assess the Potential of LEO 130852A Gel to Reduce Steroid Induced Skin Atrophy on Healthy Skin
Condition: Skin Tissue Diseases; Connective Tissue Diseases
MeSH terms: Connective Tissue Diseases; Atrophy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of LEO 130852A gel 1% in maintaining skin
      thickness in healthy skin treated with steroid.
    


Intervention name(s): Clobetasol propionate 0.05% ointment; LEO 130852A gel 1%; LEO 130852A placebo gel
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Clobetasol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Bioequivalence Study of Furosemide 40 mg Tablet in 24 Indonesian Healthy Volunteers
Condition: Drug Use
Study type: Interventional

Summary: 
      The purpose of this research was to investigate whether Furosemide 40 mg tablet manufactured
      by PT. Kimia Farma Tbk was bioequivalent to its reference drug and Lasix® 40 mg Tablet
      manufactured by PT. Aventis Pharma, Indonesia.
    

Detailed description: 
      Twenty four healty volunteers were given a single dose of Furosemide 40 mg Tablet or Lasix®
      40 mg Tablet with 240 mL of water beneath fasting condition. Then the blood samples for
      Furosemide were drawn and analyzed using UPLC. All subjects sample plasma were analyzed for
      pharmacokinetic evaluation
    

Intervention name(s): Furosemide 40 mg; Lasix® 40 mg Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Administered with 240 mL of water; Administered with 240 mL of water
Other intervention name(s): Furosemide 40 mg
Intervention MeSH terms: Furosemide
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: randomized, single blind, single dose, 2-period, cross-over design with one week washout period between each treatment in 24 healthy volunteers beneath fasting condition
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: bioequivalence; furosemide; Indonesian healthy volunteers
Randomized Controlled Trial of Tranexamic Acid in Total Knee Arthroplasty: Intravenous vs. Topical
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether topical or intravenous administration of
      tranexamic acid during unilateral total knee replacement is more effective at reducing
      bleeding in the first 24 hours following surgery. Tranexamic acid is a synthetic drug that
      has been shown to reduce blood drain output and the need for blood transfusions in both its
      topical and intravenous forms and is commonly used in orthopedic surgery. We hypothesize that
      IV and topical administration of tranexamic acid will be equally good at reducing the loss of
      blood and the need for transfusion immediately following total knee replacement.
    

Detailed description: 
      This randomized controlled trial compares the blood loss of patients undergoing unilateral
      total knee replacements who randomly receive either the topical or the intravenous form of
      tranexmamic acid during surgery. Patients in the intravenous arm of the study will receive 1
      gram of tranexamic acid in 10 milliliters of solution prior to inflation of the tourniquet
      and 1 gram of tranexamic acid in 10 milliliters of solution during closure. For patients in
      the topical arm of the study, prior to the release of the tourniquet they will receive 3
      grams of tranexamic acid in 75ccs of solution directly on the site of the incision.

      The primary result measurement will be blood drain output from the knee at 24 hours after
      surgery.
    

Intervention name(s): Topical Tranexamic Acid; Intravenous Tranexamic Acid
Intervention type(s): Drug; Drug
Intervention description(s): 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes. The surgeon will suction away excess solution. The site may be irrigated before or after the tranexamic acid bath as long as the solution is in contact for at least five full minutes. After that, the tourniquet will be released and the rest of the surgery will proceed according to the standard of care.; 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: total knee arthroplasty; total knee replacement; tranexamic acid; osteoarthritis; degenerative joint disease
Sinus Balloon Dilation in Pediatric Patients
Condition: Sinusitis
MeSH terms: Sinusitis
Study type: Interventional

Summary: 
      Safety and effectiveness of sinus balloon dilation in patients 2-21 years old.
    


Intervention name(s): XprESS device and PathAssist confirmation tools
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sinus infections; sinusitis; chronic sinusitis; rhinosinusitis; allergic sinusitis; allergic rhinitis; chronic rhinosinusitis; sinus disease in children; sinus balloon dilation; balloon dilatation; sinus disease; pediatric
Effect of Polydextrose on Fecal Bulk and Bowel Function in Mildly Constipated Subjects
Condition: Constipation; Gastrointestinal Dysfunction
MeSH terms: Constipation
Study type: Interventional

Summary: 
      Polydextrose (PDX) (8-30g/day) has been reported to increase faecal bulk and consistency,
      leading to easier stool passage in healthy subjects. Studies on its effect on defaecation
      frequency and colonic transit time have provided mixed results. The primary objective was to
      investigate the effect of PDX consumption by mildly constipated subjects on faecal bulk,
      measured as total faecal wet weight of 4-day collections. Secondary outcomes (faecal dry
      weight, defaecation frequency, stool consistency, ease of stool passage, total colonic
      transit time and gastrointestinal symptoms) were also explored. 51 subjects participated in a
      4-week, two-center, randomized, double-blind, placebo-controlled, parallel study testing a
      control (CON) and a PDX treatment (18 g/d included in biscuits and drink mixtures)
    


Intervention name(s): Polydextrose; placebo-controlled
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Polydextrose-enriched food products; Control food products
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled, parallel study.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: polydextrose; mild constipation; faecal bulk; bowel function; clinical trial; fibre
Efficacy, Tolerability, and Safety Study of DFN-15
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 3

Summary: 
      Efficacy, Tolerability, and Safety of DFN-15 in episodic migraine with or without aura, being
      conducted at multiple centers in the United States.
    


Intervention name(s): DFN-15 Active; DFN-15 Placebo
Intervention type(s): Drug; Other
Other intervention name(s): Celecoxib Oral Solution
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Assessment of a New Food Product in Metabolically at Risk Children
Condition: Cardiovascular Risk Factor; Inflammation; Micronutrient Deficiency
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The current study conducted will lend toward the optimization of the development of a food
      product that will promote a shift towards improved metabolic health. Specifically, this trial
      will determine the optimal level of protein needed to elicit positive changes in markers of
      inflammation, metabolic and micronutrient status, hepatic lipid metabolism, vascular
      function, and the relationship of these changes to the metabolome in school aged children (9
      - 13 years of age).
    

Detailed description: 
      Each participant will be asked to participate in a screening and 2 study intervention visits.
      Each intervention visit will include anthropometric measures, complete the education
      component, vascular function tests, and a blood draw and spot urine. The screening visit will
      confirm the child's eligibility for study enrollment and will serve to acclimate the child to
      the vascular function, and physical activity measurements. The remaining 2 visits will be
      scheduled 4 weeks apart. The participants will also be provided and asked to wear a physical
      activity monitor, which in addition to tracking physical activity, will also be used to
      incorporate a nutrition education program. The parent/guardian will be asked to help with
      providing the child the daily food product and to help their child fill out the compliance
      log. Volunteers will also be sought for stool and saliva collection.
    

Intervention name(s): Food Product
Intervention type(s): Other
Intervention description(s): Each food product will provide similar calories, but a different micro- and macro-nutrient composition
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blind, controlled, 4 parallel arm design
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Effect Of Deep Breathing Exercises In Smokers
Condition: Healthy Smokers
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      To determine the effect of deep breathing exercises on lung function in healthy smokers.
    

Detailed description: 
      The purpose of the study to determine the effect of deep breathing exercise in smokers
      because deep breathing improve the lung capacity by filling the lung with the oxygen and
      improve the pulmonary function, it also reduce the stress and anxiety level by slowing down
      the pace of your whole body and therefore promote general relaxation and improve the quality
      of life in smokers, muscular activity or physical activity is also increased because by deep
      breathing maximum oxygen is reached to every muscle and they get nourish well so overall
      impact of deep breathing exercise is positive. Deep breathing exercise technique offered in
      the study are easy to learn and can be performed by everyone and everywhere safely, because
      there is no complex and pain full procedure. So deep breathing exercise have been proposed as
      a way of combating cigarette craving, improves quality of life and lung function.
    

Intervention name(s): Deep Breathing exercises
Intervention type(s): Other
Intervention description(s): In pursed lip exercise subject was guided to inhale through nose with mouth closed and exhale through pressed lips (pursed lips).
In Diaphragmatic breathing subject was instructed to place his one hand below the rib cage and the other hand on chest. The patient inhaled slowly so that stomach moves out against the hand. Tighten the stomach muscle while exhaling through pursed lip.
In powered breathing subject was to inhale and exhale forcefully with some movements like subject was instructed to inhale forcefully while moving his hands upward and exhale forcefully while moving hands downward.
These three exercise techniques were advised to each subject of experimental group. They have to practice these exercises 3-4 times a day with 10 repetitions each. These exercises can be performed in sitting position or in supine lying position. Subject can adopt any position in which he feels comfortable.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study was to determine the effects of deep breathing exercises in smokers. It was conducted on the general population of Isra Institute of Rehabilitation Sciences, Isra University, Islamabad Campus. 30 participants were selected through Non probability Convenience Sampling and later equally divided into experimental (n=15) and control group (n=15) through lottery method. Inclusion criteria were young smokers between 20-30 years of age and without any chronic pulmonary complication, smoking for past five years. Smokers with any pulmonary disease, acute infections, other systemic disease, chest deformity or any disability were excluded from study.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Deep breathing exercises, smokers, lung function
Evaluation of Safety, Tolerability, PK/PD, and Metabolism of Single-Dose Singletine(DC407) in Adults
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this clinical trial is to evaluate the safety, tolerability and pharmacokinetic
      characteristics of Singletine in healthy adult subjects. The main questions it aims to answer
      are: safety and tolerability of Singletine in healthy subjects, the pharmacokinetic
      characteristics after single and multiple doses and the effect of food on the pharmacokinetic
      characteristics. Participants will be treated with Singletine orally and safety and
      pharmacokinetic evaluations will be conducted according to the protocol.
    

Detailed description: 
      This study will be an double-blinded, single-center phase I clinical trial. After being
      informed about the study and potential risks, all subjects giving written informed consent
      will undergo a 2-week screening period to determine eligibility for study entry. And then
      subjects will be administered for single-dose treatment or 7-day multiple-dose treatment and
      9-day safety follow up after the last dose of treatment. The safety and pharmacokinetic
      measures will be conducted according to the protocol.
    

Intervention name(s): Singletine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Singletine orally administered; Placebo orally administered
Other intervention name(s): Singletine（DC407）experimental group; Placebo group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy of Aprepitant (Emend®) in Children
Condition: Nausea; Vomiting; Childhood Cancer
MeSH terms: Nausea; Vomiting
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to find out whether or not adding aprepitant(Emend®) to the
      standard therapy will help children who receive chemotherapy to have less nausea and
      vomiting.
    

Detailed description: 
      1.1 Primary Aim To determine the efficacy of aprepitant (Emend®) in preventing and reducing
      chemotherapy-induced nausea and vomiting (CINV) when added to standard antiemetic drug
      regimens for children receiving highly emetogenic chemotherapy. The working hypothesis will
      be that standard therapy + aprepitant is superior at preventing CINV than standard therapy +
      placebo.

      1.2 Secondary Aim To evaluate the safety and toxicity of aprepitant (Emend®) in children
      receiving highly emetogenic chemotherapy when compared to standard antiemetic therapy +
      placebo.
    

Intervention name(s): Ondansetron, dexamethasone, aprepitant; Ondansetron, Dexamethasone, placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ondansetron 0.15 mg/kg (max 16 mg) IV or PO every 8 hours for at least 3 days, but no longer than 5 days; dexamethasone 0.2mg/kg (max 10 mg) IV or PO daily for at least 3 days, but no longer than 5 days; and aprepitant 3 mg/kg (max 125 mg) PO on day 1, and aprepitant 2 mg/kg (max 80 mg) PO on days 2 and 3 during the first investigational antiemetic cycle. During the next investigational antiemetic cycle, members of this arm will be crossed-over into the placebo arm, where the aprepitant will be replaced by placebo and the dexamethasone dose will be increased to 0.4 mg/kg (max 20 mg) daily.; Ondansetron 0.15 mg/kg (max 16 mg) IV or PO every 8 hours for at least 3 days, but no more than 5 days; dexamethasone 0.4 mg/kg (max 20 mg) IV or PO daily for at least 3 days, but no more than 5 days; and a PO placebo for 3 days during the first investigational antiemetic cycle. During the second cycle, members this group will be crossed-over to the experimental arm, where the placebo will be replaced by aprepitant and the dexamethasone will be decreased by 50%.
Other intervention name(s): Aprepitant = Emend; ARM A; ARM B
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Ondansetron; Aprepitant; Fosaprepitant; BB 1101
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Nausea; Vomiting; Children; Aprepitant; Emend®
First-day High Dose Vitamin C, E in Severe Birth Asphyxia
Condition: Birth Asphyxia
MeSH terms: Asphyxia Neonatorum; Asphyxia
Study type: Interventional
Phase: Phase 4

Summary: 
      To study the role of first-day high dose oral vitamin C and first-day single high dose oral
      vitamin E in hypoxic-ischemic encephalopathy in newborns, in the reduction of morbidity and
      adverse neurodevelopmental sequelae.
    

Detailed description: 
      Design: A prospective, randomized controlled trial over 5 months. Patients: Newborns admitted
      within 6 hours after birth with gestation >32 weeks, Apgar score of <6 at 5 minutes, features
      suggestive of neonatal encephalopathy.

      Intervention: After randomization, Group A newborns received oral vitamin C 250 mg once a day
      within a 24-hour interval along with a single dose of vitamin E 200 IU. Group B newborns
      received no intervention.

      Outcome measures: Severity and progression of birth asphyxia, duration of hospitalization and
      mechanical ventilation, mortality, and neurodevelopmental outcome.
    

Intervention name(s): Vitamin E, Vitamin C
Intervention type(s): Drug
Other intervention name(s): Evion® drops; Tablet Limcee®
Intervention MeSH terms: Vitamins; Vitamin E
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Oral vitamin C and Oral vitamin E