bioihbjkbjnl/mcl2 huggingface dataset:
Assessment of Trace Elements, Systemic Inflammation and Electrolytes
Condition: Copd
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      COPD is one of the most common causes of health problems worldwide. It is a disease that is
      associated with several systemic features that affect its morbidity and mortality.
    

Detailed description: 
      The most prominent features of COPD are systemic inflammation and oxidative stress. There is
      growing interest in establishing the significance of systemic inflammatory biomarkers in COPD
      patients, as they could be useful in evaluating exacerbations, monitoring disease
      progression, and evaluating treatment outcomes.

      C-reactive protein (CRP) is a biomarker for systemic inflammation, produced mostly by
      hepatocytes in response to tissue injury or inflammation.

      Tumor necrosis factor - alpha (TNF-α) is a key modulator of the immune system's response to
      infection. At the sites of inflammation, this cytokine regulates the function of poly-morphs
      and lymphocytes, with essentially protective benefits for the host. Increased TNF-α
      production may enhance an injury process locally and also elevated circulating levels may
      have negative systemic consequences.

      Trace elements are hypothesized to play a role in the pathogenesis of many diseases, either
      directly or indirectly. Trace elements play an important function in the inhibition and
      activation of enzyme processes .

      Zinc, for example, is a co-factor for various enzymes and is important for cell membrane
      stability, protein synthesis, proper tissue growth, and nucleic acid metabolism.

      Severity of COPD exacerbation is associated with increased levels of copper (Cu) and zinc
      (Zn).

      Patients with COPD are liable for various electrolyte derangements, especially during
      exacerbations. Hyponatremia is typically observed in the final stages of COPD. Hypokalemia
      may also occur independently or concomitantly with hyponatremia, and because magnesium plays
      a role in muscle tone, a drop in magnesium levels in COPD is a component that reduces
      respiratory muscle function and causes muscle fatigue.
    

Intervention name(s): Laboratory Tests
Intervention type(s): Combination Product
Intervention description(s): Measurement of serum level of CRP, tumor necrosis factor, zinc, copper, potassium, sodium, and magnesium in patients with stable COPD and during exacerbation.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Measurement of serum level of CRP, tumor necrosis factor, zinc, copper, potassium, sodium, and magnesium in patients with stable COPD and during exacerbation.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: COPD; Biomarkers; Trace elements; Electrolytes
The Prolonged Use of Topiramate for Preventing Migraine Headaches
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness (beyond 6 months) of
      individualized doses (100 to 200 milligrams) of topiramate for the prevention of migraine
      headaches over a period of 26 weeks.
    

Detailed description: 
      Previous studies have shown that topiramate is effective in preventing migraine headaches.
      This study will start with a 4-week baseline period in which no treatment is given, followed
      by a 26-week period in which each patient's dose is adjusted and then kept stable for 4
      weeks. The dose will start at 25 milligrams of topiramate per day and will be increased 25
      milligrams per day once weekly and then raised to either the target--100 milligrams per
      day--or the maximum dose that is well tolerated up to 200 milligrams per day. Patients
      randomized to receive topiramate will remain on that dose. The comparison phase of the study
      is a 26-week period in which the change in migraine days of patients on topiramate (taking at
      least 50 milligrams per day) is compared with the change in migraine days for patients on the
      placebo. Also studied will be the patients' health-related quality of life as assessed by
      questionnaires filled out at specific visits as well as the patients' views of the safety and
      tolerability of topiramate. The study hypothesis is that the number of migraine days,
      periods, and attacks during the last 4 weeks of the double-blind phase, relative to the last
      4 weeks of the open-label phase, is reduced more in the topiramate group than the placebo
      group. During open-label (26-weeks) and double-blind phase (26-weeks), patients receiving
      topiramate will take 25 milligrams to 100 milligrams daily by mouth; increased by 25
      milligrams per day once weekly; dose cannot exceed 200 milligrams per day and must be stable
      for the last 4 weeks.
    

Intervention name(s): Topiramate; Topiramate - Placebo
Intervention type(s): Drug; Drug
Intervention description(s): topiramate treatment started with one tablet per day, taken in the evening, for the first 7 days of the OL phase. Each tablet contained 25 mg topiramate. After one week, the dose was raised to two tablets per day: one tablet was taken in the morning, the other in the evening.; the trial medication consisted of topiramate 25 mg tablets or matching placebo tablets which were identical in appearance, taste and smell. DB randomisation phase (after the 26-weeks OL phase) were randomly allocated (1:1) to one of the two treatment groups (topiramate or placebo). The randomisation took place at Visit 6 (Week 26)
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: chronic migraine; Topiramate; migraine; headache; chronic headache
Efficacy and Safety in Subjects With Type 2 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Premixed Insulin Therapy Over a 52-Week Treatment Period and a 4-Week Follow-up
Condition: Diabetes Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this 13 month study (12 month treatment period and 1 month follow-up period)
      is to determine whether inhaled insulin is safe and effective in the treatment of type 2
      diabetes.
    


Intervention name(s): Technosphere® Insulin Inhalation Powder; 70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
Intervention type(s): Drug; Drug
Intervention description(s): Inhalation, 15U/30U; BPR 70/30, which is a premix of intermediate acting and rapid acting insulin given sc
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Protamines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Comparative Study of New Medications for Psychosis in Adolescents
Condition: Psychotic Disorders; Schizophrenia; Schizophreniform Disorders; Schizoaffective Disorders
MeSH terms: Schizophrenia; Psychotic Disorders; Mental Disorders
Study type: Interventional

Summary: 
      The overall goal of this study is to determine the efficacy and tolerability of three
      atypical antipsychotic medications (risperidone, olanzapine, and quetiapine) in the treatment
      of adolescents with psychosis. It is hypothesized that the three medications will be equally
      effective in reducing the symptoms of psychosis.
    

Detailed description: 
      The purpose of this study is to compare the efficacy and tolerance of three atypical
      antipsychotics, which are medications that have been in use for about the last 10 years, in
      the treatment of psychosis in adolescents. Efficacy refers to how well the medications work
      in decreasing symptoms associated with schizophrenia, and tolerance refers to the level of
      side effects and the compliance with taking the medications. All three medications have
      demonstrated efficacy in treating psychosis without causing extra pyramidal side effects
      (uncontrolled muscle movements) that are associated with typical, or older antipsychotic
      medications. Young people may be at a greater risk for side effects from the typical
      antipsychotic medications. There are studies of the efficacy and tolerance among patients
      under 18-years-old taking the three drugs in this study: risperidone, olanzapine, and
      quetiapine. However, at this time there is little data available comparing these three
      medications. This study is an open-label, random assignment, 12-week study to assess the
      efficacy and tolerance of these three atypical antipsychotic medications in the treatment of
      adolescents (ages 12-18) with schizophrenia or psychosis. The participants will be informed
      of which medication she/he is taking, and will be assigned to the medication randomly (based
      on chance rather than choice).

      There are additional theoretical beliefs in regard to this study as well. A secondary
      hypothesis of this study is that quetiapine will have less extra pyramidal side effects (EPS)
      and less prolactin-related side effects than risperidone. A third hypothesis is that
      quetiapine will lead to less weight gain than olanzapine and risperidone. Finally, it is
      hypothesized that because of the fewer side effects, quetiapine will be better tolerated than
      risperidone and olanzapine.
    

Intervention name(s): quetiapine; olanzapine; risperidone
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Olanzapine; Risperidone; Quetiapine Fumarate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Psychotic Disorders in adolescents; Schizophrenia in adolescents; Schizophreniform Disorders in adolescents; Schizoaffective Disorders in adolescents
A Study to Assess Ulimorelin in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase I dose escalation study involving healthy subjects.
    


Intervention name(s): Ulimorelin; Placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Intestinal Microflora in Lung Cancer After Chemotherapy
Condition: Lung Cancer; Effects of Chemotherapy; Tumor Immunity; Malnutrition
MeSH terms: Lung Neoplasms; Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      Probiotics modulate the gut microflora and immune status in lung cancer who need
      chemotherapy.
    

Detailed description: 
      Chemotherapy destroys the intestinal mucosal barrier, affects intestinal flora, causing
      bacterial translocation, infection and other complications. Probiotics may restore the
      intestinal immunity, mucosal barrier and nutrient absorption.
    

Intervention name(s): Probiotics; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Microbial composition using probiotic; Microbiota modulation using placebo
Other intervention name(s): containing clostridium butyricum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: Gut microflora; Lung cancer; Chemotherapy; Immunity; Nutrition
Drug-Drug Interaction Study With AZD9291 and Omeprazole in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, 2-period fixed sequence design to evaluate the interaction of
      AZD9291 with omeprazole in approximately 50 healthy, adult male volunteers. Volunteers will
      receive Treatment A (AZD9291 and omeprazole) in Period 1 and Treatment B (AZD9291 only) in
      Period 2. The dose of AZD9291 in Period 1 and the dose of AZD9291 in Period 2 will be
      separated by a washout of at least 21 days (the washout will not be more than 5 weeks). The
      study will be performed at up to 2 sites in the USA and will assess the effect of omeprazole
      (proton pump inhibitor) on AZD9291 exposure
    


Intervention name(s): Pharmacokinetic sampling - AZD9291; AZD9291 tablet dosing; Omeprazole tablet dosing; Pharmacokinetic sampling - AZ5140 and AZ7550
Intervention type(s): Procedure; Drug; Drug; Procedure
Intervention description(s): Blood sampling to measure AZD9291; AZD9291 80mg tablet taken on Day 5 in Period 1 and Day 1 in Period 2.; Omeprzole taken from Days 1 to 5 in Period 1.; Blood samples to measure levels of AZ5140 and AZ7550
Intervention MeSH terms: Osimertinib; Omeprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: oncology, cancer, non small cell lung cancer, anticancer druge, omeprazole, healthy volunteer
Calcium Chloride for Prevention of Uterine Atony During Cesarean
Condition: Uterine Atony; Uterine Atony With Hemorrhage; Cesarean Section Complications
MeSH terms: Uterine Inertia; Hemorrhage
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In this pilot study, investigators will administer calcium chloride or placebo to pregnant
      women undergoing Cesarean delivery who have been identified as high risk for hemorrhage due
      to poor uterine muscle contraction, or atony. They will assess whether a single dose of
      calcium given immediately after the delivery of the fetus decreases the incidence of uterine
      atony and bleeding for the mother. The pharmacokinetics of calcium chloride in pregnant women
      will also be established. Data from this pilot study of 40 patients will be used to determine
      sample size and appropriateness of a larger randomized clinical trial.
    

Detailed description: 
      Poor contraction of the uterus, also known as uterine atony, is the leading cause of severe
      blood loss during Cesarean section, both in the US and worldwide. Exogenous calcium has been
      shown to increase uterine muscle contraction in in vitro and in animal studies. Calcium is
      also an essential factor in normal blood clotting. Anesthesiologists commonly administer
      intravenous calcium chloride during Cesarean as well as other types of surgery, but formal
      randomized studies to determine efficacy in improving uterine tone have not been performed.

      In this pilot, randomized controlled study, the anesthesiologist will administer a one-time
      dose of intravenous calcium chloride 1gram versus placebo at the time of fetal delivery to
      women identified as having high risk of hemorrhage during Cesarean delivery. Primary outcome
      assessed will be a composite measure of uterine atony. Data from the pilot study will be used
      to perform power and sample size calculations for a larger study. Secondary outcomes assessed
      will include total blood loss, subjective assessment of uterine tone by the blinded
      obstetrician performing surgery, safety, side effects, and pharmacokinetic profile of calcium
      chloride in pregnant women.
    

Intervention name(s): Calcium Chloride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): All included in intervention description.
1 gram of calcium chloride in total 60 milliliters normal saline; 60 milliliters normal saline
Other intervention name(s): calcium chloride intravenous; IV calcium; Saline
Intervention MeSH terms: Calcium, Dietary; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients are randomized via stratified, permuted block randomization to receive a single dose of either calcium chloride 1 gram administered intravenously or placebo at the time of fetal delivery.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study to Test the Tolerability of an Investigational Electroporation Device in Healthy Adults (V930-001)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to evaluate the tolerability of electrostimulation applications with an
      investigational device known as the MedPulser DDS.
    


Intervention name(s): V930
Intervention type(s): Biological
Intervention description(s): Intramuscular injection of phosphate buffered saline solution will be given and within 2 - 5 minutes will be followed by an electrostimulation pulse with the MedPulser DDS in the deltoid muscle of the right arm. 15 days later, the same procedure will take place using the left arm.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Assess; Tolerability; MedPulser DDS device
Phase II Study of Ribose, Uridine, and Thymidine for a Complex Syndrome Involving Excessive 5'-Nucleotidase Activity
Condition: 5'-Nucleotidase Syndrome
MeSH terms: Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      OBJECTIVES: I. Evaluate the efficacy of oral ribose in patients with a complex
      5'-nucleotidase syndrome who have not received uridine (UR) and thymidine (TDR).

      II. Evaluate the efficacy of UR/oral ribose and UR/TDR. III. Evaluate the efficacy of oral
      ribose given in combination with UR/TDR.
    

Detailed description: 
      PROTOCOL OUTLINE: Newly identified patients receive ribose daily for 8 weeks. Patients who
      improve continue therapy. If improvement then reaches a plateau, uridine (UR) and thymidine
      (TDR) are added to the regimen.

      Patients who receive no benefit after 8 weeks of ribose are treated with UR/TDR. Patients who
      improve after 8 weeks of this combination continue therapy.

      Ribose is added to the treatment regimen for patients on UR/TDR at entry. At maximal
      improvement, TDR and UR are sequentially tapered.
    

Intervention name(s): ribose; thymidine; uridine
Intervention type(s): Drug; Drug; Drug
Primary purpose: Treatment
Keywords: 5'-nucleotidase syndrome; inborn errors of metabolism; rare disease
Feasibility of a Music Therapy Intervention to Decrease Stress During Pediatric Critical Care
Condition: Critical Illness; Hypoxia, Brain
MeSH terms: Hypoxia, Brain; Hypoxia; Critical Illness
Study type: Interventional

Summary: 
      Admission into a pediatric intensive care unit (PICU) is a highly stressful experience for
      child and family. High levels of stress can negatively impact outcomes, yet
      non-pharmacological interventions to decrease stress in the PICU are severely lacking. This
      is a prospective, single-arm feasibility trial that will explore the feasibility and
      acceptability of a music therapy intervention to decrease stress in the PICU among families
      of children receiving invasive or noninvasive mechanical ventilation.

      Objectives: The aims of this study are to: 1) Assess the feasibility of implementing a music
      therapy intervention in the PICU among children receiving invasive or non-invasive mechanical
      ventilation; 2) Determine the acceptability of the music therapy intervention in the ICU
      among caregivers, patients, and pediatric and cardiac ICU staff; 3) Explore the variability
      in child and caregiver stress outcomes throughout ICU admission. Hypothesis: The music
      therapy intervention will be feasible, as determined by recruitment, retention, protocol
      adherence, and data collection rates, and will be acceptable to participants and to PICU
      staff.

      Sample: This study will recruit 20 families that include children aged 2 months - 17 years
      old admitted with an expected length of ICU stay greater than 72 hours. Of these 20 families,
      the investigators will specifically recruit 10 families whose child is admitted for a hypoxic
      brain injury. Eligible children are receiving either noninvasive mechanical ventilation
      (i.e., continuous or bilevel positive airway pressure), invasive mechanical ventilation, or
      have an established tracheostomy tube and with escalated support settings. One primary
      caregiver will be enrolled along with the child admitted into the ICU.
    


Intervention name(s): Music therapy
Intervention type(s): Other
Intervention description(s): Patient preferred song will be provided in a sedative manor (e.g., 60-80 beats per minute) using live music (singing with guitar accompaniment) by a board certified music therapist.
Other intervention name(s): Music listening
Intervention model: Single Group Assignment
Intervention model description: Single-arm feasibility trial
Masking: None (Open Label)
Primary purpose: Supportive Care
CF101 Therapy in Patients With Moderate-to-severe Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial will test the hypothesis that the administration of CF101, a novel
      anti-inflammatory agent, to patients with moderate to severe plaque psoriasis will relieve
      signs and symptoms of the disease. CF101 effect will be in comparison to apremilast in this
      study population
    

Detailed description: 
      This is a multicenter, randomized, double-blind, placebo- and active-controlled, study in
      adult males and females, aged 18 to 80 years, inclusive, with a diagnosis of
      moderate-to-severe chronic plaque psoriasis.

      Eligible subjects will be randomly assigned to CF101 2 mg, 3 mg, matching apremilast 30 mg
      BID, or matching placebo, in a 3:3:3:2 ratio. Blinding will be maintained using a
      double-dummy technique.

      Medication will be taken orally BID for 32 weeks in a double-blinded fashion, with the option
      to continue treatment through an Extension Period to 48 weeks. Subjects initially assigned to
      the placebo group will be re-randomized at Week 16 to either CF101 2 mg, CF101 3 mg, or
      apremilast (with appropriate dose titration) in a 1:1:1 ratio and treated through Week 32,
      while subjects originally assigned to 1 of the active treatment groups will remain on that
      treatment through Week 32. The primary efficacy endpoint will be assessed at Weeks 16 and 32;
      at Week 32, all subjects will be offered the opportunity to remain on their assigned blinded
      drug through Week 48 (ie, the Extension Period of Weeks 33-48).

      Disease will be assessed using PASI , static PGA , the percentage of BSA involved, and PDI.
      Subjects will return for assessments and a new supply of study medication at Weeks 4, 8, 12,
      16, 20, 24, and 28, and for final study assessments at Week 32. For those subjects continuing
      into the Extension Period, efficacy and safety assessments will also occur at Weeks 36, 40,
      44, and 48. PK will be assessed in a subgroup of approximately 120 subjects at Weeks 0, 8,
      16, 24 and 32. PK will be assessed through sparse sampling. Assessment of whole blood A3AR
      expression levels will occur at Screening, Week 16, and Week 32.
    

Intervention name(s): CF101 2mg; CF101 3mg; Apremilast 30mg; Placebo Oral Tablet
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): CF101 tablets, 2mg BID for 16 weeks; CF101 tablets, 3mg BID for 16 weeks; Apremilast tablets, 30mg BID for 16 weeks; Placebo tablets, BID for 16 weeks
Other intervention name(s): IB-MECA; IB-MECA; Otezla; Placebo
Intervention MeSH terms: Apremilast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment