bioihbjkbjnl/mcl2 huggingface dataset:
A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 Immunoglobulin G (rCD4-IgG) in Infants and Children With Documented HIV-1 Infection
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the safety profile, assess pharmacokinetic properties (blood levels), and obtain
      preliminary indication of the antiviral and immunologic effects of recombinant CD4
      immunoglobulin G (CD4-IgG).

      CD4-IgG may be effective in blocking HIV transmission and spread, that is, CD4-IgG has
      antiviral effects. Studies done in adult patients with AIDS and AIDS related complex (ARC)
      have shown that rCD4 can be safely administered by intravenous bolus, intramuscular or
      subcutaneous injection. No serious or dose-limiting, drug-related toxicities have been
      observed to date.
    

Detailed description: 
      CD4-IgG may be effective in blocking HIV transmission and spread, that is, CD4-IgG has
      antiviral effects. Studies done in adult patients with AIDS and AIDS related complex (ARC)
      have shown that rCD4 can be safely administered by intravenous bolus, intramuscular or
      subcutaneous injection. No serious or dose-limiting, drug-related toxicities have been
      observed to date.

      Patients receive one intravenous injection the first week, followed by a 6 day washout period
      and then intravenous injections on a twice weekly basis from week 2 to week 12. The dose per
      injection may vary. The study evaluates 2 groups: (1) Children 3 months to 5 years of age;
      (2) Infants 0-3 months of age.
    

Intervention name(s): CD4-IgG
Intervention type(s): Drug
Intervention MeSH terms: CD4 Immunoadhesins
Primary purpose: Treatment
Keywords: Recombinant Proteins; Injections, Intravenous; IgG; Drug Evaluation; Acquired Immunodeficiency Syndrome; Antigens, CD4; Carrier Proteins
Effect of Different Colistin Doses on Clinical Outcome of Pediatric Cancer Patients With Gram Negative Infections
Condition: Gram-Negative Bacterial Infections; Pediatric Cancer; Colistin; Colistin Adverse Reaction; MIC
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Gram-Negative Bacterial Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Prospective randomized study comparing different colistin dosing regimens in paediatric
      cancer patient with MDR gram-negative infection or sepsis
    

Detailed description: 
      The aim of this study is to:

        1. Evaluate the clinical outcome of two different dosing regimen of IV colistin in the
           treatment of children with multidrug resistant gram-negative infections or sepsis.

        2. To estimate the frequency of colistin associated adverse effects.

        3. To correlate the serum colistin concentration and MIC to microbiological clearance and
           clinical outcome
    

Intervention name(s): Colistimethate Sodium
Intervention type(s): Drug
Intervention description(s): Intravenous injection of colistimethate Sodium 2.5 mg/kg or 5 mg/kg for Multidrug-resistance gram negative infections
Other intervention name(s): Colimycin; Colistin Sulfate; Coly-Mycin; Polymyxin E
Intervention MeSH terms: Colistin; Polymyxins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Scalp and Hair Shaft With Biologic Markers in African American and Caucasian Hair
Condition: Scalp Health
Study type: Observational

Summary: 
      The purpose of this research study is to better understand African American hair and scalp,
      its biologic appearance and how this relates to African Americans' perceptions of their hair
      and scalp health. Since most hair studies have looked at Caucasian hair and scalp, we will
      use a population of Caucasian subjects for comparison in evaluating various hair and scalp
      parameters.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy female subjects between the ages of 21-60 will be enrolled in this study. These
        subjects will be recruited from Wake Forest University Health Sciences Dermatology clinic
        and our Institutional Review Board (IRB) approved advertising. Half of the participants
        will be African American and the other half will be Caucasian.
      
Biospecimen description: 
      Hair, both broken strands and those that release from the scalp with bulb intact.
    
Keywords: Hair characteristics
Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      The aim of the ADDUCE project is to investigate any adverse effects of methylphenidate (trade
      name ritalin) on growth, neurological system, psychiatric states and cardiovascular system
      over a two year period in children and adults.
    

Detailed description: 
      Attention deficit hyperactivity disorder (ADHD) is one of the most common neurodevelopmental
      disorders in children, affecting approximately 5% children in Europe. Methylphenidate (MPH,
      trade name ritalin) is the most-commonly prescribed medication for ADHD children; it is also
      increasingly used in ADHD adults. In 2007, the European Commission requested a referral to
      the Committee for Medicinal Products for Human Use (CHMP) under Article 31 of Directive
      2001/83/EC, as amended, for MPH because of safety concerns. The CHMP concluded that study of
      the long-term effects of MPH on growth, sexual development, neurological system, psychiatric
      states and cardiovascular system is needed. In response to the CHMP s concerns, the ADDUCE
      (Attention Deficit Hyperactivity Disorder Drugs Use Chronic Effects) research team has been
      formed by a consortium of experts in the fields of ADHD, drug safety,
      neuro-psychopharmacology and cardiovascular research.

      The ADDUCE project aims to investigate the long-term adverse effects of MPH on growth,
      neurological system, psychiatric states and cardiovascular system in children and adults.

      Furthermore the ADDUCE team will develop research tools for the evaluation of adverse effects
      of MPH on cognition and motivation.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Attention Deficit Disorder clinic
      
Keywords: methylphenidate; ritalin; Attention Deficit Disorder
Complementary and Alternative Medicine Use in Low-Income African American and Caucasian Adults With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      The purpose of this study is to identify the types of and frequency of use of complementary
      and alternative medicine (CAM) strategies among low-income Caucasian and African American
      adults with persistent asthma. The overall goal is to collect data that will increase
      understanding of health beliefs and behaviors in people with low-income backgrounds so that
      studies can be created that may help modify and improve patients' symptoms of asthma.
    

Detailed description: 
      The rates of asthma-related deaths and disease are disproportionately high among African
      Americans compared to Caucasians. Surveys indicate that middle- and upper-income Caucasians
      use more CAM than African Americans, but the therapies utilized are different. This study
      will determine how well people with persistent asthma adhere to their treatment and whether
      the type and frequency of use of CAM affects treatment adherence.

      Participants will begin this study by taking part in an interview about adherence to their
      current inhaled corticosteroids (ICS) regimen and their personal CAM use. After completing
      the interview, participant adherence to their ICS regimen will be monitored for 6 weeks.
      Depending on the type of ICS participants are taking, monitoring will be conducted either by
      participant self-reporting or electronic monitors that record the time and date of medication
      inhalation. Participant adherence will also be assessed at study completion.
    

Keywords: Complementary Therapies
Topiramate vs. Placebo in Preventing Weight Gain in Bipolar Disorder Treated With Olanzapine
Condition: Bipolar Disorder; Weight Gain
MeSH terms: Body Weight; Weight Gain; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to examine the efficacy of topiramate in combination
      with olanzapine for the prevention of weight gain in youth with bipolar disorder. The
      secondary objective is to examine the tolerability of topiramate in combination with
      olanzapine for the prevention of weight gain in youth with bipolar disorder.
    

Detailed description: 
      After consent and screening, patients will be initiated on 5mg or 10mg per day of olanzapine.
      Olanzapine doses will be titrated to 10-20 mg of olanzapine over one week, to a maximum of
      20mg by day 21. Patients will also receive either topiramate (25mg bid titrated over 18 days
      to 150 mg bid. with flexibility to titrate to 200mg bid) or matched placebo. Topiramate will
      be initiated at a dose of 25 mg bid and will be increased by 25 mg bid every three days as
      tolerated. Patients will be evaluated by a blinded (to treatment status and adverse events)
      rater.
    

Intervention name(s): Topiramate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral topiramate 300-400mg/day for 12 weeks; Matched placebo to Experimental arm
Other intervention name(s): Topamax; Sugar pill
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Bipolar Disorder; Weight Gain
Validity and Reliability of Tele-Assessment Based Core Performance and Functional Capacity Tests in Healthy Individuals
Condition: Healthy
Study type: Observational

Summary: 
      The COVID-19 pandemic process has created the need for social isolation and quarantine, and
      restrictions have occurred in access to healthcare services. In this process, the trend
      towards alternative methods that will provide access to health services and the need for
      telehealth services has increased. As a result of this, when we look at the literature,
      evaluation methods used in the clinical environment in physiotherapy are frequently
      encountered in tele-evaluation. There is a need for validity and reliability studies of these
      evaluation methods in terms of tele-assessment. This study was designed to determine the
      validity and reliability of trunk endurance and functional capacity tests applied by the
      tele-assessment method in healthy individuals.
    

Detailed description: 
      Tele-health has become a service whose prevalence has increased in recent years with the
      development of technology. Tele-health facilitates the accessibility of health services for
      individuals in all segments of society. Telerehabilitation, a subcomponent of telehealth,
      provides easy access to rehabilitation services by reducing cost, time, and distance barriers
      in physiotherapy. It offers physiotherapists the opportunity to observe the musculoskeletal
      system through physical assessment, exercise program planning, distance education, and
      continuous feedback of individuals. In this sense, tele-assessment has an important place
      within the scope of health services. As a result of the restrictions that came with the
      COVID-19 process, it has become difficult for individuals to access health services. With the
      effective use of technology to eliminate this obstacle, telehealth has become an alternative
      method. Tests such as curl-up, push-up, plank, and lateral bridge are frequently used to
      evaluate trunk endurance in healthy individuals. For functional evaluation, the timed sit and
      test, the timed stand up and test, the functional anterior reach test and the one-foot
      balance test are among the most used tests in the literature. The validity and reliability of
      these methods used in the face-to-face evaluation should be determined for the correct and
      effective tele-assessment.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Healthy
      
Keywords: validity; reliability; telehealth; trunk endurance; functional capacity
AZISAST Study: AZIthromycin in Severe ASThma Study
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy, safety and cost-effectiveness of
      azithromycin as add-on therapy in adult subjects with severe persistent asthma, who remain
      inadequately controlled despite GINA (2006) step 4 or 5 therapy.
    


Intervention name(s): Azithromycin 250 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Azithromycin 250 mg three times a week during treatment period (6 months); run-in period of 2 weeks; wash-out period of 4 weeks; Placebo three times a week during treatment period (6 months); run-in period of 2 weeks; wash-out period of 4 weeks
Intervention MeSH terms: Azithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Inadequately controlled severe asthma
Safety and Tolerability of LIM-0705 in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      LIM-0705 dosed separately and in combination with tacrolimus will be safe and well tolerated.
    


Intervention name(s): LIM-0705 and tacrolimus; LIM-0705 and tacrolimus; Placebo LIM-0705 and tacrolimus; Drug LIM-0705 and placebo tacrolimus
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral solution, LIM-0705 500 mg BID for 14 days plus tacrolimus BID for first 8 days.; Oral solution, LIM-0705 750 mg BID for 14 days plus tacrolimus BID for the first 8 days.; Placebo oral solution BID for 14 days plus tacrolimus BID for the first 8 days.; Oral solution, LIM-0705 750 mg BID for 14 days plus placebo capsule BID for the first 8 days.
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Transplant
Clinical Assessment of Urinary Antiseptics Methenamine and Methylthioninium in Recurrent Cystitis
Condition: Urinary Tract Infections
MeSH terms: Urinary Tract Infections; Cystitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a double-blind, randomized, double-dummy, comparative study in parallel groups of
      subjects presenting with recurrent cystitis (≥2 episodes within the past 6 months). Subjects
      will be randomized and treated with one of two presentations of urinary antiseptics
      containing methenamine and methylthioninium for three days, followed by three days of
      antibiotic therapy as determined by urine culture and antibiogram. This study aims to assess
      the efficacy and safety of each treatment.
    

Detailed description: 
      This is a double-blind, randomized, double-dummy, comparative study in parallel groups of
      subjects presenting with recurrent cystitis (≥2 episodes within the past 6 months). After
      initial evaluations including urine culture and antibiogram, a total of 284 subjects will be
      randomized and treated with one of two presentations of urinary antiseptics containing
      methenamine and methylthioninium for six days. After three days of treatment, subjects will
      return to the study center and antibiotic therapy based on the results of the urine culture
      and antibiogram will be initiated for each subject, to be continued for the remaining three
      days of the treatment period. Efficacy assessments will include the UTISA (Urinary Tract
      Infection Symptoms Assessment Questionnaire) together with a global assessment by the
      investigator. Safety assessments will include monitoring of adverse events and laboratory
      tests carried out at each of the three study visits.
    

Intervention name(s): Methenamine + Methylthioninium; Methenamine + Methylthioninium + Acriflavine + Atropa belladona; Antibiotics
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Methenamine + Methylthioninium; Methenamine + Methylthioninium + Acriflavine + Atropa belladona; Antibiotics based on individual subjects urine culture / antibiogram
Other intervention name(s): methenamine + methylene blue; methenamine + methylene blue + acriflavine + A. belladona; Antimicrobials
Intervention MeSH terms: Anti-Bacterial Agents; Methenamine hippurate; Methenamine mandelate; Methenamine; Acriflavine; Methylene Blue
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of the Use of the Ingaron in Volunteers for the Prevention of COVID-19
Condition: COVID-19 Respiratory Infection
MeSH terms: Infections; COVID-19; Respiratory Tract Infections
Study type: Observational

Summary: 
      The main purpose of this study is to evaluate the effectiveness of the prophylactic use of
      Ingaron (INN: recombinant interferon gamma human, lyophilisate for solution for intranasal
      administration 100,000 IU) in the regimen of 3 drops in each nasal passage intranasally every
      other day for 10 days with a break of 7 days (2 10-day cycles) in volunteers.
    

Detailed description: 
      Distribution between groups is made randomly at the request of the participant. According to
      the methodology approved by the observational program, the participant must use or not use
      the investigational drug (depending on the distribution group and their own will) during the
      27 days of the prophylaxis course (10 days + 7 days + 10 days). The control group does not
      receive study therapy.
    

Intervention name(s): Interferon gamma human recombinant (IFN-G)
Intervention type(s): Drug
Intervention description(s): nasal form
Other intervention name(s): Ingaron; Interferon gamma human recombinant
Intervention MeSH terms: Interferons; Interferon-gamma
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Volunteers working in the "red zone" with patients infected with SARS-CoV-2
      
Keywords: COVID-19 prevention; interferon gamma; nasal drops
A Study To Evaluate The Effect Of WELLBUTRIN XL On Intraocular Pressure
Condition: Depressive Disorder
MeSH terms: Depressive Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted in healthy volunteers to investigate the effect on intraocular
      pressure of 2 weeks of treatment with 300mg WELLBUTRIN XL/day.
    


Intervention name(s): WellbutrinXL; placebo
Intervention type(s): Drug; Drug
Intervention description(s): WELLBUTRIN XL tablets will be available with dose strength of 150 and 300 mg.; Matching placebo tablets to WELLBUTRIN XL.
Other intervention name(s): WellbutrinXL
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Primary purpose: Diagnostic
Keywords: WELLBUTRIN XL, intraocular pressure, healthy volunteers
Narrow Band Imaging in Diagnosis of Colorectal Polyps
Condition: Colorectal Polyp; Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms; Polyps
Study type: Interventional

Summary: 
      Optical diagnosis of colorectal polyps is a promising tool to avoid risks of unnecessary
      polypectomies and to save costs of tissue pathology. NICE (NBI International Colorectal
      Endoscopic) and WASP (Workgroup on Serrated Polyps and Polyposis) classification were
      developed for diagnosis of adenomatous and sessile serrated polyps, respectively.
    

Detailed description: 
      Near-focus (NF) narrow-band imaging (NBI) is an image-magnifying technology which enables
      optical magnification of up to 65x in near focus (NF) compared with 52x in normal standard
      focus (SF) with the simple push of a button of the endoscope to be interchangeable between NF
      and SF. There were few studies comparing diagnostic accuracy between NF and SF in the
      diagnosis of colorectal polyps. So, our aim of the current study is to compare accuracy of NF
      NBI compared with SF NBI in the optical diagnosis of neoplastic and non-neoplastic polyp and
      the accuracy of NF NBI versus SF NBI in distinguishing serrated adenoma from hyperplastic
      polyp in sessile lesions using histologic evaluation as the gold standard.
    

Intervention name(s): Near Focus NBI; Standard Focus NBI
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Colonoscopy with near focus narrowing band imaging technology . Optical specifications include a 2 mm near field focal depth. Optical diagnosis of polyps were according to NICE and WASP, respectively.; Colonoscopy with narrow band imaging technology.Optical diagnosis of polyps were according to NICE and WASP, respectively.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic