bioihbjkbjnl/mcl2 huggingface dataset:
Prenatal Iron and Malaria Study
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the presence of Plasmodium infection in parturient
      women who antenatally received a combination of iron-fortified foods with iron supplements
      versus iron-fortified foods only.
    

Detailed description: 
      As per recommendations by the World Health Organization (WHO), iron supplementation in
      children should be restricted in malaria-endemic areas because of concerns that it can lead
      to an increased burden of malaria. Universal iron supplementation continues to be
      recommended, however, for women during pregnancy and 3 months postpartum. Observational
      studies have shown that iron deficiency in parturient women is associated with a marked
      reduction in the prevalence and density of malarial parasites in the placenta. Plasmodium
      infections in pregnant women have devastating effects on the foetus and neonate, causing low
      birth weight, intrauterine growth retardation, preterm delivery, spontaneous abortion,
      stillbirth and neonatal mortality. Based on our previous work, the Kenyan government is
      currently drafting legislation for mandatory iron fortification of industrially milled flour.
      Implementation of the new fortification policy means that pregnant women will receive iron
      through a combination of fortified foods and supplementation. The investigators are concerned
      about the safety of the high iron intake resulting from such a policy.
    

Intervention name(s): iron
Intervention type(s): Dietary Supplement
Intervention description(s): Daily supplementation with iron (60 mg) as ferrous sulphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Iron; Plasmodium; Malaria; Pregnancy; Kenya
A Trial Investigating the Pharmacokinetic Properties of NN1218 in Subjects With Diabetes Mellitus, Type 1
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to investigate the
      pharmacokinetic (the rate at which the body eliminates the trial drug) and pharmacodynamic
      (the effect of the trial drug on the body) profiles of NN1218 in comparison with insulin
      aspart.
    


Intervention name(s): Faster-acting insulin aspart; insulin aspart
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of 0.2 U/kg body weight faster-acting insulin aspart injected subcutaneously (under the skin) followed by single dose of 0.2 U/kg body weight insulin aspart injected subcutaneously (under the skin); Single dose of 0.2 U/kg body weight insulin aspart injected subcutaneously (under the skin) followed by single dose of 0.2 U/kg body weight faster-acting insulin aspart injected subcutaneously (under the skin)
Other intervention name(s): NN1218
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Examine the Duration of Effect of PrEP-001 in Healthy Subjects Challenged With HRV-16
Condition: Viral Upper Respiratory Tract Infection
MeSH terms: Respiratory Tract Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      A study to examine the duration of effect of PrEP-001 in healthy subjects challenged with
      HRV-16
    

Detailed description: 
      A phase IIa, randomised, double-blind, placebo-controlled study using outpatient setting to
      assess the prophylactic effect of repeated intranasal dosing of PrEP-001 in healthy subjects,
      subsequently challenged with HRV-16, on the changes in clinical symptoms when compared to
      placebo at two different dosing regimens
    

Intervention name(s): PrEP-001; Placebo
Intervention type(s): Drug; Other
Other intervention name(s): Poly-IC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Rhinovirus; Healthy volunteer; Outpatient; Cold virus; HRV-16
Detection of LADA in a Hospital in the Mexican Southeast
Condition: Latent Autoimmune Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      Patients with Latent Autoimmune Diabetes in Adults (LADA) show autoantibodies that indicate
      an autoimmune pathogenesis. Glutamic acid decarboxylase autoantibodies (GADA) are most
      prevalent islet autoantibodies in European patients with LADA. In this sense, it is
      considered that it is sufficient to determine GADA to identify subjects with LADA from
      patients with T2D for research purposes. Therefore, the aim was to investigated the presence
      of GADA in serum of subjects with T2D and its relationship with clinical criteria, metabolic
      control, drug treatment, and diabetes complications to identify possible patients with LADA
      in a hospital in southeastern Mexico is worthwhile.

      The sample was recruited at the Diabetes Clinic of the Regional Hospital of High Specialty
      "Dr. Gustavo A. Rovirosa Pérez", in the period from January 2020 to May 2021. The diagnosis
      was based in accordance with World Health Organization (WHO, 1999) criteria. Inclusion
      criteria: 1) patients previously diagnosed with T2D, 2) absence of insulin requirement for at
      least 6 months after diagnosis, 3) > 30 and < 50 years old at diabetes diagnosis, 4) BMI < 40
      kg/m2, 5) subjects who agreed to participate in the study and signed the informed consent
      before the interview.

      Serum GADA and other biochemical concentrations were determined by an enzymatic immunoassay
      method (Human Anti-Glutamic Acid Decarboxylase ELISA Kit; MyBioSource).
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects were initially diagnosed and received pharmacological treatment for T2D. In
        addition, these patients presented clinical and biochemical characteristics both of T1D and
        T2D, progressing to insulin dependency. Such individuals were invited to participate in the
        study. An endocrinologist diagnosed and evaluated all these patients.
      
Keywords: LADA; GADA; Mexican population
Does Fluoxetine Have an Effect on the CNS CRF Systems in Women Abused in Childhood?
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The primary objective of this project is to determine whether treatment with the SSRI,
      fluoxetine versus placebo reverses alterations in the central CRF system induced by early
      life stress experiences (i.e. childhood sexual and/or physical abuse) in cases with and
      without major depression. We also evaluate whether neuroendocrine changes after SSRI
      treatment correlate with clinical improvement.
    

Detailed description: 
      We compare indices of central CRF activity (i.e. ACTH and cortisol response to CRF
      stimulation test) before and after 8 weeks of treatment with either fluoxetine or placebo
      between women with a history of childhood abuse (early life stress, ELS) and current major
      depression (ELS/MDD), women with a history of childhood abuse without major depression
      (ELS/non-MDD), and women without a history of childhood abuse and major depression
      (non-ELS/MDD). Changes in neuroendocrine responses to CRF are correlated with psychological
      outcome measures. We hypothesize that treatment with fluoxetine will normalize altered
      neuroendocrine responsiveness in cases with ELS and that this normalization will be
      correlated with improvement of symptoms of depression and anxiety.
    

Intervention name(s): Fluoxetine
Intervention type(s): Drug
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Early Life Stress; HPA-axis; CRF
Safety and Pharmacokinetic Study With Multiple Ascending Doses of ORM-12741
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of multiple ascending
      doses of ORM-12741.
    

Detailed description: 
      The purpose is to evaluate the safety, tolerability and pharmacokinetics of escalating
      multiple doses of ORM-12741 in healthy volunteers.
    

Intervention name(s): ORM-12741; Placebo for ORM-12741
Intervention type(s): Drug; Drug
Intervention description(s): Ascending multiple doses to sequential panels
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy volunteer study
Minocycline HCl Extended Release Tablets 135 mg Oral Bioequivalence Study
Condition: Fasting
Study type: Observational

Summary: 
      To determine single-dose oral bioequivalence of Minocycline HCl Extended Release Tablets 135
      mg manufactured by Amneal Pharmaceuticals Co.(I)Pvt. Ltd., India and SOLODYN® (minocycline
      hydrochloride) Extended Release Tablets 135 mg Manufactured for Medicis, The Dermatology
      Company, Scottsdale, AZ 85256, by Wellspring Pharmaceutical Canada Corp., Oakville, Ontario
      L6H 1M5 in normal, healthy, adult, human subjects under fasting condition.
    

Detailed description: 
      Subjects will be fasted for at least 10 hours prior to scheduled time for dosing. As per the
      randomization schedule, one tablet of test or reference product will be administered to each
      subject with 240 mL of water at ambient temperature in each period.

      Twenty four samples will be collected from each subject during each period. The venous blood
      samples (5 mL each) will be withdrawn at pre-dose (before dosing, in the morning of the day
      of dosing) and at 1.00, 2.00, 2.50, 3.00, 3.25, 3.50, 3.75, 4.00, 4.25, 4.50, 5.00, 5.50,
      6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 48.00, 72.00, 96.00, and 120.00 hours after
      dosing. The samples collected at 48.00, 72.00, 96.00, and 120.00 hours after dosing will be
      on an ambulatory basis (i.e. on separate visit).

      After collecting the blood samples from all the subjects at each sampling time point, samples
      will be centrifuged under refrigeration with machine set at 3000 rpm, 10 minutes and 4oC.
      After centrifugation, the plasma samples will be separated and transferred into respective
      prelabeled polypropylene tubes. These polypropylene tubes will be stored below -20°C for a
      maximum period of 12 hours and then they will be stored at -70°C ± 20°C until withdrawn for
      analysis.

      Samples from all the subjects completing both periods of the study as per the approved
      protocol will be analyzed.
    

Sampling method: Non-Probability Sample
Study population: 
        A total of 18 normal, healthy, adult, human subjects will be enrolled in the study.
Vaccine Therapy Plus Interleukin-2 With or Without Interferon Alfa-2b in Treating Patients With Stage III Melanoma
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Vaccines may make the body build an immune response and kill tumor cells.
      Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Interferon
      alfa-2b may interfere with the growth of tumor cells.

      PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy plus
      interleukin-2 with or without interferon alfa-2b in treating patients who have stage III
      melanoma.
    

Detailed description: 
      OBJECTIVES: I. Determine the effect of interferon alfa-2b on the potentiation of antimelanoma
      antibodies and cellular immune responses induced by immunization to a polyvalent melanoma
      vaccine and interleukin-2 in patients with stage III malignant melanoma. II. Determine the
      optimal dose of interferon that will maximally stimulate these responses in these patients.
      III. Determine the toxicity of this regimen in these patients.

      OUTLINE: This is a randomized study. Patients are randomized into a vaccine treated control
      arm or to receive one of two doses of interferon alfa-2b plus vaccine. All patients receive
      polyvalent melanoma vaccine incorporated into interleukin-2 liposomes. The vaccine is
      administered intradermally every 2 weeks for 8 weeks, monthly for 3 months, and then every 3
      months for a total of 2 years or until disease progression. Patients assigned to arms II or
      III also receive interferon alfa-2b subcutaneously, at one of two doses, three times a week
      for 2 years. Patients are followed for survival.

      PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study within 18 months.
    

Intervention name(s): liposomal interleukin-2; polyvalent melanoma vaccine; recombinant interferon alfa
Intervention type(s): Biological; Biological; Biological
Intervention MeSH terms: Interferons; Interferon-alpha; Interleukin-2
Allocation: Randomized
Primary purpose: Treatment
Keywords: stage III melanoma
US Cycle Control and Blood Pressure Study
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      Birth Control Patch Study
    


Intervention name(s): Gestodene/EE (FC Patch Low, BAY86-5016); Oral contraceptive (equivalent to the active treatment tablets of Levlite), 21-day blister SH D00593A
Intervention type(s): Drug; Drug
Intervention description(s): 21-day regimen per cycle (1 patch a week for 3 weeks followed by a 7-day patch-free period) for 7 cycles and placebo tablets matching the conditions of the treatment of Arm 2; 21-day regimen per cycle (1 tablet a day for 3 weeks followed by a 7-day tablet-free period) for 7 cycles and placebo patches matching the conditions of the treatment of Arm 1
Intervention MeSH terms: Contraceptive Agents; Gestodene; Contraceptives, Oral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Pregnancy prevention; Female contraception; Patch
The Effect of Pain Neuroscience Education on Patients With Arthroscopic Rotator Cuff Repair
Condition: Rotator Cuff Injuries; Kinesiophobia; Pain, Postoperative
MeSH terms: Pain, Postoperative; Rotator Cuff Injuries; Kinesiophobia
Study type: Interventional

Summary: 
      During the rehabilitation process after rotator cuff repair surgery, patients suffer from
      increased pain and discomfort due to dysfunction. Pain neuroscience education, a more modern
      educational method, has been reported to be effective in controlling pain by reducing the
      fear of movement based on an understanding of neurophysiology.
    


Intervention name(s): Pain neuroscience education; Rotator cuff repair rehabilitation
Intervention type(s): Other; Behavioral
Intervention description(s): Neurophysiological education of pain allows patients to explore a wider contribution to pain through the knowledge that pain is often an unreliable indicator of the extent or extent of tissue damage. This aims at reconceptualization from biomedical or structural models to actual biological psychosocial pain models.; Postoperative rehabilitation programs include thermal therapy, electrical therapy, manual therapy, and therapeutic exercise.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Study on the Bioequivalence of Perindopril Tert-butylamine Tablets Taken on an Empty Stomach in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      In order to evaluate the bioequivalence of the test preparations and reference preparations
      of perindopril tert-butylamine tablets after meal and their safety in Chinese adult healthy
      subjects.
    

Detailed description: 
      This single-center, randomized, open-lable, single-dose, two-cycle,cross-over design
      bioequivalence test was conducted in subjects under fasting conditions. Subjects were fasted
      for at least 10 hours overnight in each cycle，but can't ban their from drinking water.The
      next morning according to test-reference (TR) or Reference-test (RT) sequential oral
      perindopril tert-butylamine tablets (4 mg, 240 mL warm water) . Each period was separated
      with a 14-day washout period in fasted trials. The blood concentrations of perindopril and
      perindoprilat in qualified subjects were tested. Safety assessment includes vital signs
      examination, physical examination, laboratory safety examination, coagulation examination,
      electrocardiogram and adverse event reports.
    

Intervention name(s): Perindopril tert-Butylamine tablets （ Produced by Haisco）; Perindopril tert-Butylamine tablets（ACERTIL®）
Intervention type(s): Drug; Drug
Intervention description(s): The trial is divided into two cycles, between of two cycle with a 14-day wash-out period. In the first cycle, the subjects in experimental group took the test preparation perindopril tert-butylamine tablets on an empty stomach, and the subjects in control group took the reference preparation ACERTIL® on an empty stomach. The subjects of the two groups exchanged on the 15th day after the first administration take medicine. A single oral administration was used for both cycles, and the dose was 4 mg.; The trial is divided into two cycles, between of two cycle with a 14-day wash-out period. In the first cycle, the subjects in experimental group took the test preparation perindopril tert-butylamine tablets on an empty stomach, and the subjects in control group took the reference preparation ACERTIL® on an empty stomach. The subjects of the two groups exchanged on the 15th day after the first administration take medicine. A single oral administration was used for both cycles, and the dose was 4 mg.
Intervention MeSH terms: Perindopril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: perindopril tert-butylamine; Bioequivalence study; fasting
Safety and Immunogenicity Study of 3 Vaccinations With TICOVAC in 2 Dosages in Healthy Children Aged Between 6 Months and 3 Years
Condition: Encephalitis, Tick-borne
MeSH terms: Encephalitis, Tick-Borne; Encephalitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to evaluate a) whether the seroconversion rates in children are
      equivalent after two and/or three partial vaccinations with TICOVAC 0.25 mL and TICOVAC 0.5
      mL, and b) whether there is a difference in terms of safety between the two products.
    


Intervention name(s): Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Tick-Borne Encephalitis
Comparison of Different Oxygen Delivery Strategies During Resuscitation of Babies
Condition: Prematurity; Oxidative Injury; Respiratory Distress
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Preterm infants are born with immature lungs and often require help with breathing shortly
      after birth. This currently involves administering 100% oxygen. Unfortunately, delivery of
      high oxygen concentrations leads to the production of free radicals that can injure many
      organ systems. Term and near-term newborns deprived of oxygen during or prior to birth
      respond as well or better to resuscitation with room air (21% oxygen) compared to 100%
      oxygen. However, a static concentration of 21% oxygen may be inappropriate for preterm
      infants with lung disease. Our study will investigate how adjusting the amount of oxygen
      given to sick preterm newborns will affect the ability to maintain a safe oxygen level in
      their blood. Each infant will be assigned to receive one of three treatments at birth.
      Resuscitation will either start with 21% oxygen and be increased if needed, 100% oxygen and
      be decreased if needed or 100% oxygen with no changes made (current standard of treatment).
      The first two groups will have adjustments in oxygen concentration as needed to reach a safe
      target range of blood oxygen saturation. We anticipate that preterm newborn infants
      resuscitated with higher oxygen concentrations will have higher than "normal" levels of
      oxygen in their blood while those resuscitated initially with lower concentrations of oxygen
      will be more likely to have "normal" oxygen levels in their blood. All premature infants will
      have a surface probe placed on the right hand to measure the saturation of blood with oxygen.
      Following the resuscitation, treatment will proceed as per standard of care until hospital
      discharge. All infants will be admitted to the neonatal intensive care unit given their
      prematurity. The purpose of this study is to investigate how safely restricting the amount of
      oxygen delivered to newborns during resuscitation will affect the amount of oxygen in their
      blood.

      Hypothesis: In this randomized control trial, infants resuscitated with a "low oxygen
      delivery (LOD)" strategy (initiation of resuscitation with 21% O2) will remain normoxemic for
      the greatest proportion of time during resuscitation and infants resuscitated with a "high
      oxygen delivery (HOD)" strategy (100% O2 used for the entire resuscitation) will be
      normoxemic for the smallest proportion of time during resuscitation.
    


Intervention name(s): titration of oxygen during resuscitation
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Single Ascending Oral Dose Study of SDI-118 in Healthy Male Subjects Including an Assessment of Receptor Occupancy and Food Effect
Condition: Cognitive Disorders
MeSH terms: Cognitive Dysfunction; Cognition Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a First-in-Human, Randomized, Placebo-controlled, Single Ascending Oral Dose Study of
      SDI-118 in Healthy Male Subjects including Receptor Occupancy Measurements after Single Dose
      of SDI-118 and an Assessment of Food Effect.
    


Intervention name(s): SDI-118; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SDI-118 Powder in Capsule; Matching Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment