bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Added Enzyme α-Galactosidase at a Carbohydrate-rich Meal in Irritable Bowel Syndrome (IBS)
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Early Phase 1

Summary: 
      IBS (irritable bowel syndrome) is a functional gastrointestinal disorder which is
      characterized by recurrent pain and/or discomfort, altered stool form, and abdominal
      distension. It has been established that food items such as beans, peas, lentils, peppers,
      and onions can increase gas production. What these have in common is that they all contain
      large amounts of complex carbohydrates. The enzymes in the small intestine are not able to
      fully digest these large molecules, which in turn are fermented by the colonic microflora.
      This fermentation is conducted through the production of short chain fatty acids and gases
      such as hydrogen and methane. Alpha-Galactosidase is an enzyme that has the ability to break
      down these indigestible carbohydrates to galactose and sucrose in the small intestine and to
      facilitate the absorption and minimize the gas production from bacteria in the colon.

      The aim of this study is to assess if the gastrointestinal symptoms, above all problems from
      gas and distension, is alleviated when the enzyme α-Galactosidase (present in Nogasin
      capsules) is ingested with food.
    


Intervention name(s): Alpha-Galactosidase
Intervention type(s): Dietary Supplement
Intervention description(s): The study is conducted during a total of two days at two different occasions. Visit 1: The patients will be served breakfast and lunch at the gastro unit and dinner will be enclosed when the patient leave for home. At each meal (breakfast, lunch, and dinner) the participants will ingest three capsules with a total content of 1200 GaIU alpha-galactosidase-randomized to be either the enzyme (α-Galactosidase) or a non-active substance (placebo). Visit 2: The procedure from visit 1 will recur after at least two weeks has passed - except that the content of the capsules will be opposite from the first visit.
No other food or beverage are ingested from 1800 hours the evening before the intervention day until breakfast the day after intervention (no exact time).
Other intervention name(s): Nogasin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gastrointestinal Symptoms; Bloating; Distention
Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children
Condition: Diarrhea; Rotavirus Infection
MeSH terms: Rotavirus Infections; Diarrhea
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of probiotics in rotavirus acute
      diarrhea in children. The investigators will compare the effect of two different probiotics
      products.
    

Detailed description: 
      Acute diarrhea remains being the second most frequent infectious condition in children,
      producing a high number of admissions yearly. In children below one year of age, rotavirus
      represents the main etiologic agent, both in developed and developing countries. In Bolivia,
      acute diarrhea affects about 30% of the group below 5 years of age. Probiotics appear as one
      of the alternatives currently under discussion. Also, evidence available suggests that
      probiotics shorten the time of diarrhea and therefore the time of rotavirus excretion. In
      daily practice, we are often limited by the type and number of probiotics products locally
      available; moreover, information about combined products is scarce. With this in mind, in
      this study we compared the efficacy of two commercially available products.
    

Intervention name(s): GB (Florestor); GRALB; GC (placebo)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): S. Boulardii preparation of 1 gram twice daily for 5 days; mixed probiotic preparation 1 gram twice daily for 5 days.; Placebo 1 gram twice daily for 5 days.
Other intervention name(s): Florestor, Bioflora; Probiotik, mixed probiotic; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Keywords: acute diarrhea; rotavirus; probiotic; children
Mortality and Morbidity Associated With New Onset Acute Kidney Injury in Critically Ill COVID-19 Infection Patients
Condition: Acute Kidney Injury
MeSH terms: Acute Kidney Injury; Wounds and Injuries
Study type: Observational

Summary: 
      This study explored the incidence of morbidity and mortality associated with AKI in
      critically ill adult patients infected with COVID-19. There are two groups for comparison.
      Group1. patients were directly admitted to the intensive care unit (ICU) from the emergency
      department (ED) Group 2. patients were initially managed on the medical floor and later
      transferred to the ICU for worsening respiratory status. The investigating team evaluated the
      correlation of inflammatory markers and common risk factors such as obesity, diabetes,
      hypertension and ethnicity to the development of AKI in the target population. The primary
      outcome is mortality participants will received their regular healthcare in a medical setting
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This is a two-year retrospective study of critically ill adult patients infected with
        COVID-19 that were admitted to the intensive care unit on ventilatory support. Patients
        included in this study were admitted to Arrowhead Regional Medical Center (ARMC) from March
        1, 2020 to February 12, 2022.
Medical Office Intervention for Adolescent Drug Use - Attention Study Supplement
Condition: Substance-related Disorders
MeSH terms: Substance-Related Disorders
Study type: Observational

Summary: 
      This study will use the CCPT II to assess attention in 12-21 year olds enrolled in a
      randomized controlled trial of a brief behavioral treatment for substance abuse.

      This study will describe at baseline levels of attention using a well validated instrument
      (Connors Continuous Performance Test II) and explore the association between attention levels
      and substance use. The primary study hypothesis is that lower initial levels of substance use
      (as measured by percent days abstinent) will be associated with higher attention levels. We
      envision that this data will inform a better understanding of how attention may modify
      treatment response.
    

Detailed description: 
      Research among adolescents with substance use problems presents unique challenges to
      investigators. Issues with recruitment, confidentiality, and follow-up have been cited as
      common limitations to research in this area. One likely contributor to decreased treatment
      persistence and follow-up is the limited ability to sustain attention that many adolescents,
      especially those with substance problems, may manifest. (Taper, 2002) Thus, assessing
      attention before beginning substance abuse treatment has the potential not only to inform the
      science of adolescent addiction medicine, but also to guide the development of therapies to
      specifically address attention deficits among adolescent substance users. Adolescent
      outpatients being treated for substance problems have not been systematically studied for
      clinical or subclinical attention levels.

      The primary aims this study are as follows:

        1. To test the feasibility of administering the Connors Continuous Performance Test II
           (CCPT II), a well validated measure of attention, to a sample of 12-21 year old patients
           receiving treatment for substance abuse.

        2. To obtain baseline descriptive statistics on the CCPT II in a previously understudied
           group of young patients receiving treatment for substance abuse.

        3. To estimate the magnitude of the association between substance use and levels of
           attention at baseline before treatment.

        4. To explore the degree to which attention may affect response to substance abuse
           treatment in general and specifically motivational interviewing.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants in this study will be 12-21 year old patients who have been referred to the
        Adolescent Substance Abuse Program for evaluation of drug or alcohol use and are
        participating in the parent study, "Medical Office Intervention for Adolescent Drug Abuse."
      
Keywords: Alcohol abuse; Drug abuse
Trial Comparing Intensity Modulated Radiotherapy Versus Conformal Radiotherapy to Treat Prostate Cancer With Hypofractionated Schedule
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      There is no randomized controlled trial (RCT) comparing Conformal Radiotherapy (3DCRT) versus
      the Intensity Modulated Radiotherapy (IMRT) in terms of toxicity and disease control. Data
      from retrospective studies show that IMRT reduces the risk of severe late complications. More
      recently, the results from the RTOG 0126 study have also confirmed the benefit from IMRT in
      reducing acute toxicity for prostate cancer treated with conventional dose escalation.
      Therefore, to investigate the real clinical benefit of the IMRT over 3DCRT using a
      hypofractionated schedule in prostate cancer, the investigators developed a RCT.
    


Intervention name(s): IMRT
Intervention type(s): Radiation
Intervention description(s): The IMRT plan consisted of five - seven fields to deliver the same dose prescribed at the isodose line covering 95% of PTV.
The 3DCRT plan consisted of six fields to deliver a total dose of 70 Gy/ 25 fractions of a single daily dose of 2.8 Gy.
Other intervention name(s): 3DCRT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypofractionated schedule; Intensity Modulated Radiotherapy; Conformal radiotherapy
Study of Travoprost Ophthalmic Solution, 0.004% Compared to Timolol (0.5% or 0.25%) in Pediatric Glaucoma Patients
Condition: Pediatric Glaucoma; Elevated IOP in Pediatric Patients; Ocular Hypertension in Pediatric Patients
MeSH terms: Glaucoma; Ocular Hypertension; Hydrophthalmos
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the intraocular pressure (IOP)-lowering efficacy of
      Travoprost 0.004% POLYQUAD (PQ) ophthalmic solution compared to Timolol ophthalmic solution
      (0.5% or 0.25%) in pediatric glaucoma patients.
    


Intervention name(s): Travoprost 0.004% PQ ophthalmic solution; Timolol, 0.5% or 0.25% ophthalmic solution; Travoprost Vehicle
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients 2 months to < 3 years of age received 0.25%; Inactive ingredients used to maintain masking
Intervention MeSH terms: Timolol; Travoprost; Pharmaceutical Solutions; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Sleep and Obesity in Teenagers
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This study aims to investigate

        1. whether sleep extension results in improvements of endocrine and metabolic markers of
           obesity and diabetes in obese teenagers,

        2. the relationship between habitual sleep quality and duration and markers of obesity and
           diabetes in lean and obese teenagers.
    

Detailed description: 
      Inclusion of 13 obese teens. Duration : 1 week of screening period + 1 week of intervention:
      habitual/extended sleep length + 1 week of intervention: extended/habitual sleep length. A
      wash out period of at least 3 months will be required between the two interventions.

      Inclusion of 13 non obese healthy teen controls for measuring reference sleep duration and
      physiology level. Duration for these group: 1 week of screening period + 1 week of habitual
      sleep length
    

Intervention name(s): habitual sleep length period + extended sleep length period; extended sleep length period + habitual sleep length period
Intervention type(s): Behavioral; Behavioral
Intervention description(s): On obese group, realisation of an habitual sleep length period followed by an extended sleep length period; On obese group, realisation of an extended sleep length period followed by an habitual sleep length period
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Obesity; Glucose metabolism disorders; Appetite regulation; Sleep; Adolescent; Randomized controlled trials
Cost Effect of Erector Spina Plane Block
Condition: Cost Effectiveness
Study type: Interventional

Summary: 
      Use of erector spina plane (ESP) block for postoperative analgesia is continuously
      increasing. However, few studies have investigated intraoperative effects of ESP block. The
      investigators aim to study the effects of ESP block in terms of cost-effectiveness,
      consumption of inhalation agents and opioids in perioperative and postoperative period.
    

Detailed description: 
      Erector spina plane (ESP) block has analgesic efficiency and its popularity is growing
      steadily. ESP block forms a sensorial block by local anesthetic infiltration between the
      musculus erector spina and facia. ESP block given to participants undergoing laparoscopic
      cholecystectomy for postoperative opioid analgesia resulted in a decrease of postoperative
      pain scores in the first 24 h. Due to increases in health expenditure, cost control is
      becoming more and more important. Cost-effective studies are important in healthcare
      economics. Inhaled anesthetics used in anesthesia departments account for about 20% of total
      anesthetic agents. Local anesthetic agents decrease the minimum alveolar concentration (MAC)
      value of inhaled agents. And also in perioperative and post operative period, the anesthetic
      management often need to be supported with opioid drugs. The investigators think that ESP
      block has analgesic effects and decreases the consumption of inhalation agents. The
      investigators aim to investigate the cost-effectiveness of ESP block in anesthetic
      applications in laparoscopic procedures.
    

Intervention name(s): erector spina plane block, cost analysis
Intervention type(s): Other
Intervention description(s): in preopererative period, ESP block is going to utilise for postoperative analgesia for patients who undergo laparoscopic procedure and cost analysis will make after the end of 24 hour of operation
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Screening
Effect of Crestor (Rosuvastatin) on Lipid Levels in Patients With Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective is to evaluate the efficacy of rosuvastatin therapy on plasma lipid
      profile (Low Density Lipoprotein (LDL), High-Density Lipoprotein (HDL), total cholesterol,
      triglyceride) in patients with metabolic syndrome.
    


Intervention name(s): rosuvastatin
Intervention type(s): Drug
Intervention description(s): medication start dose is 10mg. After 6 weeks of treatment will be force-titrated to 20mg.
Other intervention name(s): CRESTOR
Intervention MeSH terms: Rosuvastatin Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: plasma lipid profile; metabolic syndrome
Single Group Study of the Safety of and Immune Response to a Bird Flu Virus Vaccine (H5N1) in Healthy Adults
Condition: Influenza; Virus Diseases
MeSH terms: Virus Diseases; Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      Over the past decade, avian influenza (AI) has become a major health concern. The development
      of a safe and effective vaccine against H5N1 infection is important. The purpose of this
      study is to determine the safety of a new AI vaccine in healthy adults.
    

Detailed description: 
      According to the World Health Organization, the current pandemic risk associated with avian
      influenza H5N1 infection is serious, as an increasing number of humans are infected.
      Currently, H5N1 influenza transmission occurs in humans when they are exposed through direct
      contact to infected poultry or surfaces and objects contaminated by infected poultry feces. A
      pandemic occurs when a new influenza subtype emerges that infects humans, causes serious
      illness, and spreads easily among humans. The development of a safe and effective vaccine is
      necessary, should a pandemic occur. The purpose of this study is to evaluate the safety and
      immunogenicity of a live, attenuated A1 virus vaccine, H5N1 (6-2) AA ca Recombinant (A/Hong
      Kong/213/2003 x A/AnnArbor/6/60 ca).

      This study will last approximately 16 weeks. Participation in this study includes a hospital
      stay in an isolation unit at the Johns Hopkins Bayview Medical Center. All participants will
      receive two doses of vaccine in nasal spray form, at study entry and sometime between 4 and 8
      weeks after initial vaccination. Participants will be admitted to the isolation unit 2 days
      prior to each vaccination. A targeted physical exam will occur daily following each
      vaccination until discharge. Participants will not be discharged until nasal washes are
      negative. Vital signs measurement will be done at least twice daily for the duration of the
      inpatient stay. A follow-up outpatient visit will occur approximately 4 weeks following each
      vaccination. Blood and urine collection will occur at selected timepoints throughout the
      study.
    

Intervention name(s): H5N1 (6-2) AA ca Recombinant (A/Hong Kong/213/2003 x A/AnnArbor/6/60 ca)
Intervention type(s): Biological
Intervention description(s): Intranasal vaccine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Bird Flu
Self-collected Swabs for HPV Testing in 18-24 Year Old Women
Condition: Papillomavirus Infections
MeSH terms: Papillomavirus Infections
Study type: Observational

Summary: 
      The purpose of this study is to compare methods for transporting self-collected swabs for HPV
      testing in 18-24 year old women and to look at risk factors for HPV infection in 18-24 year
      old women.
    

Detailed description: 
      We propose a cross-sectional study among 150 women in the United States who have used
      Internet dating sites in the past year in order to examine risk factors for high-risk HPV
      infections in 18-24 year old online daters, and evaluate strategies for transporting and
      storing self-collected samples for HPV testing. We will ask participants to complete a
      written questionnaire on their health, sexual behavior, and attitudes toward self-collecting
      vaginal swabs, HPV vaccination, and cervical cancer screening. Also, we will ask the women to
      self-collect two sequential vaginal swab samples that will be transported and stored
      according to the two strategies described above. Each sample will be tested for type-specific
      HPV DNA using a PCR-based assay.
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        18 to 24 year old women who date online
      
Biospecimen description: 
      Self-collected vaginal samples for HPV testing
Effect of Daily Low Dose Aspirin on Exhaled Inflammatory Mediators in Normal Subjects
Condition: Healthy
Study type: Interventional

Summary: 
      Hypothesis: Low dose aspirin does not change exhaled inflammatory breath mediators in normal
      subjects.
    

Detailed description: 
      Aim:

        1. To study the effect of low dose aspirin on exhaled breath inflammatory mediators

        2. To compare the change to that seen in diseased states such as asthma and
           Lymphangioleiomyomatosis (LAM)

      We will interview healthy volunteers to confirm that they do not have any major underlying
      medical conditions such as heart disease, diabetes, stroke and bleeding disorders. We will
      collect breath condensate before and after two weeks of low dose over the counter enteric
      coated aspirin 81 mg/day therapy. Side effects are extremely rare at this dose, but include
      bleeding, heart burn and allergic reaction.
    

Intervention name(s): aspirin
Intervention type(s): Drug
Intervention description(s): 81 mg orally daily for two weeks
Intervention MeSH terms: Aspirin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: healthy volunteers; aspirin; Normal healthy subjects
An Observational Study of Patients With Primary Mitochondrial Disease (SPIMM-300)
Condition: Primary Mitochondrial Disease
MeSH terms: Mitochondrial Diseases
Study type: Observational

Summary: 
      This is an observational study of patients with Primary Mitochondrial Disease with either
      signs or symptoms suggestive of myopathy. The Investigator will identify potential patients
      through existing medical records and one on-site visit.
    

Detailed description: 
      An observational study of patients with presumed Primary Mitochondrial Disease designed to
      better characterize and correlate symptoms and signs of myopathy and genetic test results and
      the use of commonly prescribed treatments. The study will help define and identify a subject
      population for a future trial of an investigational product to treat primary mitochondrial
      disease associated with signs and symptoms of myopathy.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with clinical presentation of PMD with either signs or symptoms suggestive of
        myopathy
      
Keywords: Primary Mitochondrial Disease; Stealth; Myopathy; exercise intolerance; muscle pain; Mitochondrial Myopathy; Primary Mitochondrial Myopathy