bioihbjkbjnl/mcl2 huggingface dataset:
Isomil Post Marketing Observational Study
Condition: Cow's Milk Allergy
MeSH terms: Hypersensitivity; Milk Hypersensitivity
Study type: Observational

Summary: 
      The use of soy-isolate protein based formula for infants with cow's milk protein intolerance
      is common in Indonesia, however, there has not been any systematic collection of clinical
      data to determine the formula's gastrointestinal tolerance, and the parent's perceptions
      regarding the formula.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infants with symptoms suggestive adverse reactions to cow's milk protein
Treatment of Anal High-grade Squamous Intraepithelial Lesions (HSIL) Through Use of a Chinese Herbal Topical Cream
Condition: Anus Neoplasms
MeSH terms: Anus Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to find out if a Chinese herbal cream is effective in treating
      HSIL (high-grade squamous intraepithelial lesions, also known as HGAIN, or high-grade anal
      intraepithelial neoplasia).
    

Detailed description: 
      The purpose of this study is to test a new noninvasive topical cream, AIJP (Arnebia Indigo
      Jade Pearl), for treatment of precancerous anal lesions in order to prevent their progression
      to anal cancer. AIJP is a topical Chinese herbal cream that has been specifically designed to
      treat people with the cancer precursor lesions caused by human papillomavirus (HPV). In
      general, HPV infection is a key factor in development of cervical, anal and vulvar cancers.
      People with HIV are especially vulnerable to develop anal cancer associated with HPV. It is
      known that prior to development of anal cancer a person develops a precancerous condition
      known as a high-grade squamous intraepithelial lesion (HSIL). Treatment of the HSIL can
      prevent progression to anal cancer. Current therapies for HSIL and anal cancer are highly
      invasive. A new effective noninvasive topical therapy for precancerous HSIL could have a high
      impact on prevention of anal cancer.
    

Intervention name(s): AIJP (Arnebia Indigo Jade Pearl); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will administer their own treatment using 1/4 teaspoon of the cream twice daily for 48 weeks.; Placebo twice daily for 48 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: HSIL; HGAIN; AIN; neoplasia; dysplasia; TCM; Traditional Chinese Medicine
A Study to Evaluate Participants Satisfaction, Quality of Life and Effectiveness of Flexible-Dose of Paliperidone Extended Release (ER) in Participants With Schizophrenia, Previously Treated With Risperidone
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate effectiveness, tolerability (how well a participant
      can stand a particular medicine or treatment), and safety of flexible-dose of paliperidone
      extended release (ER) in participants with schizophrenia (psychiatric disorder with symptoms
      of emotional instability, detachment from reality, often with delusions and hallucinations,
      and withdrawal into the self), previously taking risperidone (an antipsychotic), but who are
      not satisfied with their treatment.
    

Detailed description: 
      This is an open-label (a medical research study in which participants and researchers are
      told which treatments the participants are receiving, "unblinded"), multi-center (when more
      than 1 hospital or medical school team work on a medical research study), non-randomized,
      single-arm study of paliperidone ER in participants previously treated with risperidone with
      poor response. The study will consist of 2 phases: a main phase of 6 months and an extension
      phase of another 6 months. The total duration of the study will be 12 months. All
      participants will receive an oral (having to do with the mouth) daily dose of paliperidone ER
      in flexible dosage (in the range of 3-12 milligram [mg]: 3 mg, 6 mg, 9 mg, or 12 mg)
      according to Investigator's discretion. Efficacy and safety of participants will primarily be
      evaluated by Positive and Negative Syndrome Scale (PANSS) and Extrapyramidal Symptoms Rating
      Scale (ESRS), respectively. Participants' safety will be monitored throughout the study.
    

Intervention name(s): Paliperidone Extended Release (ER)
Intervention type(s): Drug
Intervention description(s): Paliperidone ER tablets in the flexible dose ranging from 3 to 12 mg will be administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator's discretion.
Intervention MeSH terms: Paliperidone Palmitate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Paliperidone
Botswana Diarrheal Diseases Study
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      The goals of this study are to:

        1. determine the diarrheal rates, morbidity, mortality, and pathogens present among
           breast-fed infants born to HIV-infected mothers.

             -  analysis by HIV status of infants, method of feeding, HIV viral loads / CD4 counts
                of infected mothers.

             -  comparison to rates among infants born to HIV uninfected mothers.

        2. link analysis of the functional quality of immunoglobulins in the breast milk of
           HIV-infected and uninfected mothers.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Primary care clinic
      
Keywords: Prevention of Mother-Infant HIV Transmission
Platelet Rich Plasma on Osteoarthritis of Knee
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Although few studies have showed beneficial effect of platelet rich plasma (PRP) for
      osteoarthritis of knee (OA knee), only one study applied randomized, control method and none
      of them has the objective measurements such as balance test or muscle strength which were
      reported as decrease in patients with OA knees. We assess the analgesic effect and the extent
      of improved muscle strength and balance after PRP in patients with OA knee.
    

Detailed description: 
      Patients with bilateral OA knee will be enrolled and randomized into intervention and control
      knee. One dose of PRP is applied in the intervention knee and normal saline in control side.
      Outcome measurements included visual analog scale (VAS)、Lequesne's severity index、Western
      Ontario and McMaster Universities Osteoarthritis Index (WOMAC)、balance test (Biodex) and
      isokinetic strengthening test at different follow-up frame (2nd week, 1st month, 3rd month
      and 6th month after treatment).
    

Intervention name(s): platelet rich plasma; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders.; The normal salin as the placebo intervention was injection in the other side of knee.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Platelet rich plasma; Osteoarthritis of knee; Balance; Strength
Effect of Pasta on Blood Glucose Response in Normal Subjects
Condition: Blood Glucose Concentration; Type 2 Diabetes; Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      The objective of this study is to determine whether ingestion of modified pasta products
      (Dreamfields, Miracle Noodles) result in an improvement in blood glucose concentration when
      compared with a traditional pasta.
    

Detailed description: 
      On one occasion the pasta will be a traditionally available pasta; on another occasion,
      approximately 1 week later a modified pasta, advertised to contain ~ 5 grams of digestible
      carbohydrate, or to be low in digestible starch, will be studied.
    

Intervention name(s): modified pasta
Intervention type(s): Other
Intervention description(s): 50 grams carbohydrate as a single breakfast meal
Other intervention name(s): Dreamfields Pasta, Miracle Noodles
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Keywords: Low Biologically Available Glucose Diet (LoBAG diet); Diabetes; Glycemic Index
Evaluation of Potential for Drug Interaction Between SCH 58235 (Ezetimibe) and Pitavastatin (Study P03962)(COMPLETED)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was designed to evaluate the pharmacokinetic interaction and safety of
      coadministration of SCH 58235 (ezetimibe) and pitavastatin in healthy Japanese adult male
      subjects or adult male subjects having no obvious disease other than high cholesterol levels.
    


Intervention name(s): SCH 58235; pitavastatin
Intervention type(s): Drug; Drug
Intervention description(s): SCH 58235 10 mg (once daily); Pitavastatin 2 mg (once daily)
Other intervention name(s): Ezetimibe
Intervention MeSH terms: Ezetimibe; Pitavastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Synbiotic Treatment in Crohn's Disease Patients
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether administration of a synbiotic, comprised on
      inulin and a bifidobacterial probiotic will colonise the gut wall and down-regulate TNF-alpha
      and other pro-inflammatory cytokines in the mucosa of Crohn's patients with active disease to
      reduce mucosal inflammation and induce remission.
    

Detailed description: 
      Crohn's disease is one of the two main forms of idiopathic inflammatory bowel disease. The
      Th1-mediated inflammatory response in Crohn's disease is characterised by increased IL-18 and
      INF-gamma and especially TNF-alpha, which are formed by lamina propria mononuclear cells. The
      aim of this investigation is to determine whether a synbiotic comprised of inulin and a
      bifidobacterial probiotic, that we have previously shown to down-regulate TNF-alpha and other
      proinflammatory cytokines in the gut mucosa in ulcerative colitis patients with active
      disease, can colonise the bowel wall, reduce mucosal inflammation and induce remission in
      Crohn's disease patients with active disease, in a randomised controlled trial. Crohn's
      disease is associated with high mortality and incurs significant social, commercial and NHS
      costs. Many patients are refractile to standard treatments, which often have undesirable side
      effects. An inexpensive, effective and non-toxic treatment based on the synbiotic concept
      would contribute greatly to relieving the clinical and financial burdens of the disease.
    

Intervention name(s): Synbiotic (Synergy I / B.longum)
Intervention type(s): Drug
Intervention MeSH terms: Sulfalene
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Crohn's; TNF-alpha; Synbiotic; Probiotic
Comparison of Caudal Block Versus Dexmedetomidine Infusion in Pediatric Patients Undergoing Hypospadias Repair Surgery
Condition: Dexmedetomidine Infusion; Pediatric; Hypospadias Repair Surgery
MeSH terms: Hypospadias
Study type: Interventional

Summary: 
      Pain is one of the most misunderstood, underdiagnosed, and untreated medical problems,
      particularly in children. New Joint Commission on Accreditation of Health Care Organization
      regards pain as fifth vital sign and requires caregivers to regularly assess pain. Inadequate
      pain relief during childhood may have long-term negative effects including harmful
      neuroendocrine responses disrupted eating and sleep cycles and increased pain perception
      during subsequent painful experiences. Also, postoperative pain can result in an
      uncooperative and restless child. Hence, it is preferable to prevent the onset of pain rather
      than to relieve its existence.

      Various multimodal techniques have been designed for pediatric pain relief. These include
      both systemic and regional analgesia. The most commonly used regional technique is caudal
      epidural block. Advantages of the caudal block are smoother recovery with less distress
      behavior, early ambulation, decreased the risk of chest infections, decreased postoperative
      analgesic requirements, and early discharge.

      In our culture; considerable number of parents still refuses caudal anesthesia fearing from
      the rare neurological sequelae may occur. This the motive for searching for parenteral
      surrogate gives clear headed recovery resembles regional analgesia.

      Dexmedetomidine is an alpha 2 agonist which has sedative, analgesic, and opioid-sparing
      effect. It prolongs the duration of analgesia by its local vasoconstrictive effect and by
      increasing the potassium conductance in A-delta and C-fibers.

      It also exerts its analgesic action centrally via systemic absorption or by diffusion into
      the cerebrospinal fluid and reaches alpha 2 receptors in the superficial laminae of the
      spinal cord and brainstem or indirectly activating spinal cholinergic neurons. The sedative
      effects of dexmedetomidine are mostly due to stimulation of the alpha 2 adrenoceptor in the
      locus coeruleus
    


Intervention name(s): Dexmedetomidine; caudal block
Intervention type(s): Drug; Procedure
Intervention description(s): 1 mcg/kg IV over 10 minutes followed by 0.5 mcg/kg/hr; After negative aspiration of blood or cerebrospinal fluid, 2 mg/ kg of bupivacaine at concentration of 0.5% (volume 0.5ml/kg) was given as per the group assigned, then the site of injection was dressed, and the patient was turned supine.
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Manitoba Inflammatory Bowel Disease Cohort Study
Condition: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis
MeSH terms: Crohn Disease; Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Observational

Summary: 
      The Manitoba Inflammatory Bowel Disease (IBD) Cohort Study participants were drawn from a
      population-based research registry.

      The cohort consisted of 388 adult enrollees with recent IBD onset who completed the baseline
      survey and interview in 2002 to 2003. Participants were followed every 6 months with surveys
      and annually with interviews. Diagnosis and disease type were verified by chart review.
    

Detailed description: 
      The Manitoba Inflammatory Bowel Disease (IBD) Cohort Study, initiated in 2002, is study of
      adults with IBD who have been tracked prospectively through annual clinical interviews and
      semiannual surveys. The participants were drawn from a validated population-based research
      registry, which identified and recruited individuals using an administrative definition of
      IBD from the comprehensive health data base of Manitoba Health, the single insurer that
      provides health care to all residents in the province.

      The cohort consisted of 388 adult enrollees with recent IBD onset who completed the baseline
      survey and interview in 2002 to 2003. Participants were followed every 6 months with surveys
      and annually with interviews. Diagnosis and disease type were verified by chart review. It
      has been demonstrated that the Cohort is representative of the provincial IBD population as a
      whole, with comparable age distribution, sex distribution, disease duration, and rural/urban
      residence.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Complete data were obtained in the first contact from 388 individuals. Over the first two
        years of the longitudinal cohort study, there was a modest level of attrition and by the
        time of the 24 month contact 353 respondents continued to participate.

        The participating persons have been followed annually with in-person interviews and with
        semi-annual mail-in surveys. By the end of 5 years 353 persons were still participating (a
        loss of 1.8%/year).

        Participants age was 18-83 and 60% are females. Approximately two thirds live in Winnipeg
        and the rest live throughout Manitoba including Brandon, Dauphin, Swan River, Flin Flon,
        Thompson, Winkler and Steinbach. Some subjects live elsewhere in Canada, yet still maintain
        their participation.

        270 subjects were followed until 2016
      
Biospecimen description: 
      Plasma, DNA
Interest of Self-compression Technique on Tolerance of Mammography
Condition: Breast Cancer
Study type: Interventional

Summary: 
      Mammography is used for screening, diagnosis, therapeutic evaluation and monitoring of local
      cancer breast.

      It is sometimes poorly tolerated by some patients who complain of an uncomfortable
      examination or pain.

      Breast compression by the manipulator aims to reduce the thickness of the breast during
      mammography; This act is an important factor of pain or discomfort felt by the patient. But,
      it is also an image quality factor.

      This study aimed to compare self-breast compression by the patient to the compression
      standard technique carried out by the manipulator.
    


Intervention name(s): mammography according to an auto-compression procedure; mammography according to a standard procedure; questionary
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: mammography; pain; quality of life; screening; image quality; radiology
Placebo and Active Controlled, Double Dummy Study to Prove Efficacy of Aspirin in Treatment of Acute Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the efficacy and safety of 1000 mg Aspirin (the
      study medication) by comparing it to placebo (the control group without active substance) or
      400 mg Ibuprofen (the control group with an active substance) in treating the symptoms of
      back pain. The study is designed to develop a treatment method against back pain which will
      have more advantages for patients than the methods that are currently available.
    


Intervention name(s): Acetylsalicylic Acid (Aspirin, BAYE4465); Ibuprofen; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Aspirin 1000 mg (solid dose caplet) to be given three times daily as for 2 consecutive days (48 hours), followed by Aspirin 1000 mg (solid dose caplet) to be taken as per need, but not more than three times daily for the following 3 days (72 hours). Total treatment period has not to exceed 5 days and total daily dose has not to exceed 3000 mg Aspirin.; Ibuprofen 400 mg caplet to be given three times a day as for 2 consecutive days (48 hours), followed by ibuprofen 400 mg caplet to be given as per need, but not more than three times a day for the following 3 days (72 hours). Total treatment period has not to exceed 5 days and total daily dose has not to exceed 1200 mg ibuprofen.; Placebo (two placebos: Placebo Aspirin and Placebo Ibuprofen) to be given three times a day for a maximum of 5 consecutive days in the same regimen as for Experimental Drug and Active Comparator.
Intervention MeSH terms: Aspirin; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Back Pain; Acute low back pain
A Safety and Efficacy Study of BBI-4000 in Subjects With Axillary Hyperhidrosis
Condition: Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the safety and efficacy of 3 doses of BBI-4000 and vehicle (4 treatment arms), when
      applied once a day for 4 weeks, for the treatment of axillary hyperhidrosis.
    

Detailed description: 
      This is a Multicenter, Randomized, Double Blind, Vehicle-Controlled Study to Evaluate the
      Safety and Efficacy of 3 concentrations of Topically Applied BBI-4000 in Subjects with
      Axillary Hyperhidrosis.

      Participating subjects will apply BBI-4000 once a day for 4 weeks in their axillae. The 4
      week treatment period will be followed by a 2 week follow-up period.

      Safety will be assessed through collection of vital signs, adverse events, local skin
      responses, hematology and serum chemistry laboratory testing and ECGs.

      Efficacy will be assessed using the Hyperhidrosis Disease Severity Scale (patient reported
      outcome) and through gravimetrically measured sweat production.

      PK blood samples will be taken from study subjects from selected centers.
    

Intervention name(s): BBI-4000 Gel, 5%; BBI-4000 Gel, 10%; BBI-4000 Gel, 15%; Vehicle
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): BBI-4000 Gel, 5%; BBI-4000 Gel, 10%; BBI-4000 Gel, 15%; Placebo, BBI-4000 Gel, 0%
Other intervention name(s): BBI-4000 Low Dose; BBI-4000 Middle Dose; BBI-4000 High Dose; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Progesterone Variation on the Final Day of Oocyte Maturation.
Condition: Controlled Ovarian Stimulation; Progesterone Variation on Trigger Day; Circadian Rhythm; Oocyte Donors
Study type: Observational [Patient Registry]

Summary: 
      The current study, aims through a robust design to provide a simple answer on whether
      progesterone levels of the same individual may significantly vary depending on the time of
      blood retrieval before the ovulation triggering, by evaluating the daily variability of serum
      progesterone on the day of triggering in healthy women who perform a COS for oocyte donation,
      through multiple blood samplings.
    


Intervention name(s): Serum progesterone measure
Intervention type(s): Diagnostic Test
Intervention description(s): Serum Progesterone will be measured in all donors on the day triggering at 8:00 am, 12:00 p, 16:00 pm and 20:00 pm
Intervention MeSH terms: Progesterone
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy oocyte donors according to spanish law for oocyte donation