bioihbjkbjnl/mcl2 huggingface dataset:
Cholecalciferol Intervention to Prevent Respiratory Infections Study
Condition: Respiratory Tract Infection; Vitamin D Deficiency
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections; Vitamin D Deficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a feasibility double-blind randomised controlled trial in 32 participants. It
      evaluates the feasibility of a full trial which will examine the efficacy of weekly
      supplementation of cholecalciferol (vitamin D3) relative to placebo on the subsequent
      frequency and severity of objectively-verified symptomatic acute respiratory tract infection,
      overall and as a proportion of detected colonisations of the upper respiratory tract by 9 of
      the most common aetiologic viral pathogens.
    

Detailed description: 
      The hypotheses of the full study are:

      Primary The group treated with vitamin D3 will have a significantly lower frequency of
      symptomatic respiratory tract infections than controls.

      Secondary

        1. Among persons with detected viral colonisations of the nasopharynx, treated persons will
           have a lower frequency of symptomatic respiratory tract infection resultant than
           controls.

        2. Treated group will have significantly less severe symptomatic RTIs than controls.

        3. Treated group will have significantly shorter symptomatic RTI durations than controls.

      For the pilot, a cohort of 32 healthy young adults satisfying inclusion criteria will be
      randomised to cholecalciferol supplement or identical placebo and evaluated daily for the
      occurrence of RTI symptoms and evaluated weekly for the presence of respiratory colonisation
      by relevant pathogens using nasopharyngeal swab and polymerase chain reaction using selected
      pathogen-specific primers. This pilot will demonstrate the logistic feasibility of the
      proposed study design and provide preliminary data which will inform a larger study to be
      undertaken next year.
    

Intervention name(s): Cholecalciferol; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 20,000 IU cholecalciferol capsule, given once weekly for 16 weeks.; Microcellulose capsule identical in appearance to treatment
Intervention MeSH terms: Cholecalciferol; Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Vitamin D; Cholecalciferol; Respiratory tract infection
MK0476 Study in Adult Patients With Acute Asthma (0476-322)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates the efficacy and safety of MK0476 intravenous administration in adult
      patients with acute asthma.
    


Intervention name(s): montelukast sodium; Comparator: Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 7 mg or 14 mg single injection; Placebo single injection
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bioequivalence Study of Lamotrigine 25 mg Chewable Tablets of Dr.Reddy's Under Fasting Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the pharmacokinetics and bioequivalence of
      lamotrigine formulations after administration of single doses to non-smoking, healthy
      volunteers under fasted conditions.
    

Detailed description: 
      A single-dose, two-way, bioequivalence study in up to 26 normal, non-smoking, healthy males
      and females will be utilized to evaluate the pharmacokinetics and bioequivalence of
      Lamotrigine chewable dispersible formulations under fasted conditions.
    

Intervention name(s): Lamotrigine
Intervention type(s): Drug
Intervention description(s): Lamotrigine Tablets (chewable, dispersible), 25 mg
Other intervention name(s): Lamictal
Intervention MeSH terms: Lamotrigine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Crossover; Lamotrigine (chewable, dispersible)
Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations in Fed and Fasting in Healthy, Postmenopausal Women
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to determine the effect of a high-fat meal on the bioavailability
      and PK of a single, oral dose of BZA/CE (PNP) 20mg/0.625 strength tablet, assessing both the
      BZA and CE components.
    


Intervention name(s): Bazedoxifene/conjugated estrogens combination
Intervention type(s): Drug
Intervention MeSH terms: Bazedoxifene; Estrogens; Estrogens, Conjugated (USP)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Optical Quality, Threshold Target Identification, and Military Target Task Performance After Advanced Keratorefractive Surgery
Condition: Myopia; Myopic Astigmatism
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      To determine the effect of two types of wavefront modalities (WFG vs. WFO) and two types of
      refractive surgery (PRK vs. LASIK) on visual and military task performance after laser
      refractive surgery.
    


Intervention name(s): WFG PRK; WFG LASIK; WFO PRK; WFO LASIK
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cryogenic Preservation of Spermatozoa
Condition: Fertility; Spermatic Parameters
Study type: Observational

Summary: 
      The reference technique for the conservation of gametes is storage in liquid nitrogen but new
      vats of nitrogen vapor (storage over liquid nitrogen) or in dry phase (storage in an
      insulated compartment of liquid nitrogen in a tank Liquid nitrogen) also allow the storage of
      flakes. The purpose of this work is to evaluate the dry-phase cryopreservation technique of
      liquid nitrogen compared with liquid-phase storage, depending on the duration of
      cryopreservation.
    

Detailed description: 
      Objective: To evaluate the effects of cryopreserved sperm in dry and liquid phase nitrogen at
      3 and 6 month on sperm numeration, motility, vitality, morphology, acrosomal integrity and
      DNA fragmentation.

      Design: Experimental study, investigator was blinded to the type of Cryopreservation.

      Patient(s): Semen samples were collected from patients who came in laboratory for semen
      analysis

      Intervention: Samples were frozen with a programmable freezing unit. Each semen sample was
      divided into two aliquots. One aliquot was plunged into liquid nitrogen and the other was
      stored in dry-phase nitrogen for 3 or 6 month. Thawing was performed at room temperature.
    

Intervention name(s): cryopreservation
Intervention type(s): Other
Intervention description(s): Samples were frozen with a programmable freezing unit. Each semen sample was divided into two aliquots. One aliquot was plunged into liquid nitrogen and the other was stored in dry-phase nitrogen for 3 or 6 month. Thawing was performed at room temperature
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Men undergoing routine semen analysis for infertility for reproductive medicine of
        university hospital in Clermont-Ferrand
      
Keywords: Cryo preservation; Spermatic nuclear quality
Ovarian Reserve in Crohn's Disease
Condition: Crohn Disease; Ovary Disease; Anti-Mullerian Hormone Deficiency
MeSH terms: Crohn Disease
Study type: Observational

Summary: 
      Crohn's disease reduces fertility by inducing inflammation both directly and in the fallopian
      tubes and ovaries and indirectly through surgical interventions and tubal adhesions
      associated with disease treatment. Anti-mullerian hormone (AMH) is a reliable indicator of
      ovarian reserve in women. The aim of this study was to compare serum AMH levels in women with
      Crohn's disease and healthy controls. In this study, the investigators aimed to investigate
      AMH and ovarian capacity in the study group with crohn's disease and in the control group
      without disease.
    


Intervention name(s): AMH levels in young women with crohn's disease will be considered.
Intervention type(s): Other
Intervention description(s): Ovarian Reserve in Young Women of Reproductive Age with Crohn's Disease;Blood will be taken from both the study and control groups and the AMH level will be evaluated.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study group consisted of young women in the reproductive age with crohn's disease.
Comparison of the Efficacy and the Safety of Different Schedules of Administration of Sub-lingual Immunotherapy
Condition: Pollen Allergy
MeSH terms: Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      The dose and the mode of administration of sublingual therapy remain open questions to
      determine the efficacy and safety of this desensitization therapy, the main purpose of this
      study is to evaluate if different routes of administration (oral-vestibular vs. sublingual)
      and a maximum dose of allergen administered are able to determine a different effect or a
      different incidence of side effects of the therapy in a group of patients with
      rhinoconjunctivitis and/or asthma due to ragweed
    

Detailed description: 
      Version 1 16/02/2011 The allergen-specific immunotherapy represents an important therapeutic
      option for the treatment of allergic respiratory diseases. Its clinical efficacy is well
      demonstrated, although the mechanism of action is still under study.

      The main purpose of immunotherapy is to induce an allergen-specific tolerance so that the
      natural exposure to the allergen does not cause clinical symptoms.

      The clinical efficacy of standard subcutaneous immunotherapy (SCIT) is known. A meta-analysis
      Cochrane on the clinical efficacy of SCIT in allergic rhinitis 51 double-blind studies with a
      total 2871 patients) demonstrated a reduction in symptoms in 73% of patients and a reduction
      in the use of drugs in 57%.

      Other studies also show that SCIT was effective in the long term (at least 3-5 years of
      suspension) reduces sensitization to new allergens, prevents progression of allergic rhinitis
      in asthma and significantly improves the symptoms of asthma, hyper- bronchial reactivity and
      the use of asthma medications.

      Sublingual immunotherapy (SLIT) represents an effective alternative route of administration
      of vaccine therapy with an allergic profile security than the SCIT.
    

Intervention name(s): Slit One; Slit One; Slit One ragweed
Intervention type(s): Biological; Biological; Biological
Intervention description(s): slit one sublingual immunotherapy 200 stu; slit one vestibular immunotherapy 200 stu; slit one 400 stu dose ragweed (sublingual doubled immunotherapy)
Other intervention name(s): Slitone (Alk Abello); Slitone (Alk Abello); Slitone (Alk Abello)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of CM310 in Patients With Uncontrolled Seasonal Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      Allergic rhinitis (AR) is a non-infectious chronic inflammatory disease of the nasal mucosa
      mainly mediated by immunoglobulin E after exposure to allergens in atopic individuals. The
      typical symptoms of AR are paroxysmal sneezing, watery rhinorrhea, itching, and nasal
      congestion, which may be accompanied by ocular symptoms, including eye itching, tearing,
      redness, and burning sensation, which are more common in patients with hay fever allergies.
      Bronchial asthma is associated with bronchial asthma in 40% of patients with AR, suggesting a
      comorbid feature of allergic disease.
    

Detailed description: 
      AR is a common clinical chronic nasal disease, affecting 10% to 20% of the world's
      population, and has become a global health problem. AR not only seriously affects the quality
      of life of patients, resulting in patient fatigue, impaired learning, attention, and
      decision-making ability, but also causes a heavy social burden.

      AR has a variety of classification methods. According to the type of allergen, it can be
      divided into seasonal (SAR, common allergens are seasonal allergens such as pollen) and
      perennial (PAR, common allergens are indoor allergens such as dust mites or occupational
      allergies), which is a classification method often used in clinical studies. According to the
      course of the disease, it can be divided into intermittent (symptom onset < 4 days/week, or <
      4 consecutive weeks) and persistent (symptom onset ≥ 4 days/week, and ≥ 4 consecutive weeks).
      According to the severity of the disease, it can be divided into minor AR (mild symptoms,
      with no significant impact on quality of life) and moderate-severe AR (more severe or severe
      symptoms, with significant impact on quality of life). The results of the cooperative survey
      showed that persistent moderate-to-severe disease was the most common in the overall
      population, accounting for 52.2%, indicating that the treatment and control of AR has become
      an urgent problem to be solved.
    

Intervention name(s): Interleukin-4 receptor responders 1; Interleukin-4 receptor responders 2; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Interleukin-4 receptor was injected subcutaneously.; Interleukin-4 receptor was injected subcutaneously.; Placebo was injected subcutaneously.
Intervention MeSH terms: Interleukin-4
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effectiveness of Dual Therapy (Lopinavir/Ritonavir + LamivudinE) in Treatment-Experienced HIV Infected Patients in the Russian Federation
Condition: HIV-1 Infection
Study type: Observational

Summary: 
      This study seeks to assess the virologic effectiveness of dual therapy (lopinavir/ ritonavir
      (LPV/r) + lamivudine (3TC)) in treatment-experienced human immunodeficiency virus 1 (HIV-1)
      infected participants with an undetectable plasma HIV-1 (ribonucleic acid) RNA level (for at
      least 6 months) at the 48 week time point of treatment in the routine clinical settings of
      the Russian Federation.
    


Intervention name(s): lopinavir/ritonavir; lamivudine
Intervention type(s): Drug; Drug
Intervention description(s): tablet; tablet
Intervention MeSH terms: Ritonavir; Lopinavir; Lamivudine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        HIV-1 infected participants on any triple HAART with undetectable plasma HIV-1 RNA level
        for at least 6 months (two consequently plasma HIV-1 RNA levels) transferred as medically
        appropriate to LPV/r + 3TC in the routine clinical settings.
      
Keywords: antiretroviral therapy
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults
Condition: Meningococcal Infections; Meningococcal Meningitis
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the lot to lot consistency, safety and immune response of the
      Novartis Meningococcal ACWY conjugate vaccine in healthy US adolescents and adults.
    


Intervention name(s): MenACWY CRM; Meningococcal ACWY Conjugate vaccine
Intervention type(s): Biological; Biological
Intervention description(s): One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.; One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Meningococcal; meningitis; vaccine; adolescents; adults
Physical Activity Level in Patients With OSAS During Covid-19 Pandemic
Condition: Obstructive Sleep Apnea-hypopnea Syndrome
MeSH terms: COVID-19; Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      As long as the people stay at home because of the Covid 19 outbreak, the investigators assume
      that the sleep quality of OUAS patients, like everyone else, and the sleep quality of
      COVID-19 outbreak are reduced due to anxiety and anxiety in people. In addition, we assume
      that sleep quality and physical activity level are related to health literacy level and fear
      of movement (kinesiophobia). In this study; the investigators aimed to determine how patients
      are affected by this process by evaluating sleep quality, physical activity, fear of movement
      and health literacy in OSAS patients during our stay in the COVID-19 outbreak.
    

Detailed description: 
      Research Ahi Evren Chest Cardiovascular Surgery Training Research Hospital will be performed
      in patients between the ages of 18-70 years, diagnosed with OSAS in the sleep laboratory.
      Sleep quality, physical activity, fear of movement and health literacy will be evaluated in
      OSAS patients. Evaluations will be made by phone In order for the study to be strong, it will
      be tried to reach the maximum patient that can be taken between June 2020 and October 2020.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients and healthy individuals between 18-70 years old, who are diagnosed with OSAS in
        the sleep lab at the Ahi Evren Chest, Heart and Vascular Surgery Training and Research
        Hospital, and whose local language is Turkish will be included in the study.
      
Keywords: physical activity; COVID-19; sleep quality
Evaluation of an Osteoporosis Prevention Strategy in Women With Osteoporotic Fracture of the Upper Limb
Condition: Osteoporosis With Current Fragility Fracture
MeSH terms: Osteoporosis; Fractures, Bone
Study type: Interventional

Summary: 
      Osteoporosis is a disease characterized by reduced bone mass and increased skeletal
      fragility, predisposing to an increased fracture risk. The presence of a low trauma fracture
      is a powerful predictor of future fractures and about 50% of patients with a fragility
      fracture will suffer a subsequent fracture in the next 10 years (Center Jacqueline R, 2007).
      Osteoporotic fractures are associated with an increased morbidity and mortality but also high
      financial costs. However, less than 20% of patients presenting a low trauma fracture receive
      an appropriate post-fracture osteoporosis management (Little and Eccles, 2010). The
      hypothesis of a lack of information and an under assessment of consequences by both patients
      and physicians has been raised to explain this gap between recommended care and usual
      practices.

      The aim of the PREVOST program is to assess the efficiency of patient-centered osteoporosis
      prevention program, after a fragility fracture of the upper limb, to improve post-fracture
      management of osteoporosis (ie BMD test and / or osteoporosis treatment) in women over 50
      years old.

      This open randomized controlled trial aims to compare the BMD or osteoporosis treatment
      prescription rate at 6 months after inclusion between two groups: "intervention" receiving
      information on fracture and osteoporosis (oral and written), phone call reminders and written
      information to give to their family physician, and "control" receiving usual care without
      information.
    


Intervention name(s): Osteoporosis prevention program
Intervention type(s): Behavioral
Intervention description(s): Women will receive an oral information and advices on osteoporosis, a written leaflet on osteoporosis (risk factors, diagnosis, prevention and treatments), a letter and a leaflet on osteoporosis management to give to their family physician and phone call reminders (D15, D30, D45) to advise them to consult their family physician and, if they have a BMD prescription, to perform their BMD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: osteoporosis; fragility fracture; secondary prevention
Exploratory Cognition Study of Sertindole in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this exploratory study is to evaluate the effects of sertindole and olanzapine
      on neurocognitive functioning in patients with schizophrenia.
    

Detailed description: 
      Cognitive deficits, including impairments in areas such as memory, attention, and executive
      function, are major determinants and predictors of long-term disability in schizophrenia. At
      present, available antipsychotic medications are relatively ineffective in improving
      cognition. However, scientific discoveries during the past decade suggest that it may be
      possible to develop medications that are effective in improving cognition in schizophrenia.

      One of the important reasons to focus on cognitive deficits as a target for pharmacological
      treatment, is the association found between cognitive impairment and social dysfunction
      observed in patients with schizophrenia. Pervasive cognitive deficits have a limiting effect
      on the quality of life of patients with schizophrenia including social interaction and
      problem solving, community living, and employment prospects.
    

Intervention name(s): Sertindole; Olanzapine
Intervention type(s): Drug; Drug
Intervention description(s): 12 to 20 mg daily after initial up-titration, encapsulated tablets, orally, 84 days; 10 to 20 mg daily after initial up-titration, encapsulated tablets, orally, 84 days
Other intervention name(s): Zyprexa
Intervention MeSH terms: Olanzapine; Sertindole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia