bioihbjkbjnl/mcl2 huggingface dataset:
Treatment Regimen in Menstrual Cycle Regularization and Persistence in Routine Clinical Practice in Russia, Ukraine, Kazakhstan and Uzbekistan
Condition: Irregular Menstrual Cycle
Study type: Observational

Summary: 
      Dydrogesterone is approved in more than 100 countries including Russia, Ukraine, Kazakhstan
      and Uzbekistan and widely used for the treatment of progesterone deficiencies such as for
      management of dysmenorrhea, endometriosis, secondary amenorrhea, irregular cycles,
      dysfunctional uterine bleeding, pre-menstrual syndrome, threatened and habitual miscarriage,
      infertility due to luteal insufficiency, as well as part of hormone replacement therapy.
      There are limited data regarding dydrogesterone's role in achieving cycle regularization from
      post-marketing settings. There is need to assess the persistence of dydrogesterone therapy in
      a post-marketing setting after cessation of treatment and whether the persistence, if any, is
      related to the duration of dydrogesterone therapy. Hence, in this observational program, the
      goal is to observe the possible implications of such treatment in terms of treatment length
      and response pattern.
    

Detailed description: 
      The program is designed as a prospective, multicentre, observational, non-interventional,
      non-randomized, non-controlled, single arm, post-marketing program. Being an observational
      program, the assignment of patients to dydrogesterone therapy will not be decided with an
      intention to include patients in the program, but will be guided as per standard clinical
      practice of the treating physician. Hence the prescribing of dydrogesterone will be clearly
      separate from the decision to include patients in this program. All dydrogesterone
      prescriptions will be made in accordance with locally approved package insert for
      dydrogesterone.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        women with irregular menstrual cycle due to progesterone deficiency
      
Keywords: Dydrogesterone; Irregular Menstrual Cycle; Progestins
Biomarker(s) for Glucocorticoids
Condition: Addison Disease
MeSH terms: Addison Disease
Study type: Interventional

Summary: 
      The investigators have shown that patients with adrenal insufficiency (Addison's disease), a
      rare disorder, have doubled the expected mortality rate in Sweden despite Standard of Care
      glucocorticoid (GC) replacement. One % of the Swedish population are, however, receiving GCs
      for inflammatory diseases, but management is empirical and adjusted to underlying disease
      activity. The desired anti-inflammatory therapeutic effects cannot be differentiated from the
      adverse metabolic (osteoporosis, obesity, diabetes mellitus) and immunosuppressive side
      effects of GC. This frequently results in suboptimal GC therapy with adverse effects due to
      over-dosing or poor efficacy due to under-dosing. The primary aim is to identify a biomarker
      for the metabolic effects of GCs. Patients with Addison's disease completely lack endogenous
      GCs and can therefore be considered a human GC knock-out model. They can therefore be studied
      during near-physiological exposure and during GC starvation. This will uniquely allow a very
      clean biomarker identification model (using transcriptomics, proteomics and metabolomics).
      The secondary aim is to validate candidate biomarker(s) in a dose-response study using the
      same patient population. A biomarker of GC actions will make it possible to individualised
      therapy during pharmacological GC treatment. It would allow GC replacement to be monitored in
      Addison's disease and could become a specific diagnostic tool in patients with GC deficiency
      and excess (Cushings syndrome).
    


Intervention name(s): Hydrocortisone; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): SoluCortef®; Sodium chloride 0,9%
Intervention MeSH terms: Hydrocortisone; Hydrocortisone hemisuccinate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Biomarker; Glucocorticoids; Metabolism; Pharmacology; Metabolomics
The Relationship Between Helicobacter Pylori Infection and Inflammatory Bowel Diseases: A Real-life Observation
Condition: Inflammatory Bowel Diseases; Helicobacter Pylori Infection
MeSH terms: Infections; Communicable Diseases; Helicobacter Infections; Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Observational

Summary: 
      Numerous epidemiological studies have investigated the association between Helicobacter
      pylori (H. pylori) infection and inflammatory bowel disease (IBD) with various conflicting
      results. The main objective of this study is to further explore the possible association
      between H. pylori infection and IBD and its impact on disease course. The investigators
      sought to conduct a prospective observational study and enroll a total of 182 IBD patients
      who were screened for H. pylori infection. All the participants will be clinically evaluated
      at the initial visit and bimonthly for 3 months. Several factors will be explored such are
      diet, physical activity, life style and considering specific environmental exposures that
      impact the development of disease or its relapse.
    


Intervention name(s): Observation
Intervention type(s): Other
Intervention description(s): Follow up and observe under standard of care given
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients diagnosed with inflammatory bowel disease condition
      
Keywords: Inflammatory Bowel Diseases; Helicobacter Pylori; Egypt
Seroma at the Donor Site of the TRAM Flap, With or Without Quilting Suture: A Comparative Study Using Ultrasound
Condition: Seroma
MeSH terms: Seroma
Study type: Interventional
Phase: Phase 1

Summary: 
      Patient undergoing breast reconstruction with lower abdominal flap, benefit when points are
      used for membership (between the aponeurosis of the abdominal flap and underlying muscles)
      for closing the donor area, where there is reduced incidence of complications.
    

Detailed description: 
      This study evaluated seroma formation at the donor site of the TRAM patients who underwent
      breast reconstruction. Forty-eight breast reconstructions were performed using the bipedicled
      TRAM flap. The patients were randomly allocated into three groups of 16 participants each: DN
      group, use of suction drains but no quilting sutures between the remaining abdominal flap and
      musculoaponeurotic layer of the anterior abdominal wall; QS+DN group, use of quilting sutures
      and suction drains; and QS group, use of quilting sutures but no suction drains. In order to
      determine seroma formation, ultrasound examinations were performed on postoperative days 7
      and 14 in 5 regions of the abdominal wall: epigastric, umbilical, hypogastric, right iliac,
      and left iliac regions.
    

Intervention name(s): quilting suture
Intervention type(s): Procedure
Intervention description(s): quilting sutures and drains
quilting sutures but no drains
Other intervention name(s): points
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Quilting suture; seroma; Procedure; Surgery
AZD9164 Single Ascending Dose Study in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The aims of the study are to assess the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of AZD9164 following single ascending dose administrations to healthy male
      subjects.
    


Intervention name(s): AZD9164; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Each subject will receive a single-dose starting dose 4µg (lung deposited dose) with up to 8 dose escalations not exceeding AstraZeneca pre-defined exposure limits.; Each subject will receive a single-dose.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: safety; tolerability; healthy; inhalation; Healthy males
A Study to Evaluate the Immune Response to the ASP7374 and Its Safety in Healthy Adult Volunteers
Condition: Healthy; Immunogenicity of ASP7374
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This trial is designed as a blinded, randomized and parallel group study to investigate the
      clinically recommended dosage for ASP7374 based on the comparison of the immunogenicity and
      safety among two doses of subcutaneous ASP7374 and one dose of intramuscular ASP7374 in
      healthy adults.
    


Intervention name(s): ASP7374
Intervention type(s): Biological
Intervention description(s): subcutaneous and intramuscular
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Recombinant Influenza hemagglutinin vaccine
Short-term Regulation of Energy and Macronutrient Balance: Impact of Energy Flux
Condition: Healthy
Study type: Interventional

Summary: 
      Aim of the study is to investigate the impact of energy flux (achieved by changes in physical
      activity) under the conditions of energy balance, caloric restriction and overfeeding in
      healthy subjects.
    

Detailed description: 
      A low energy flux is achieved by low energy expenditure, equivalent to low physical activity
      and with a corresponding low energy intake. A high energy flux is achieved by high energy
      expenditure, equivalent to high physical activity and with a corresponding high energy
      intake, respectively.

      The protocol of this randomized, intra-individual nutrition intervention includes 12 one-day
      interventions with 3 different levels of energy flux and 4 different diet conditions.
    

Intervention name(s): physical activity; energy intake
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 3 different levels of physical activity; 4 different types of energy intake
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: physical activity; energy balance; caloric restriction; overfeeding; appetite regulation
Specific Language Impairment (SLI) in Children May Caused by Epileptic Brain Activity
Condition: Specific Language Impairment
MeSH terms: Language Disorders; Specific Language Disorder
Study type: Observational

Summary: 
      The objective of this study was to find if there is a possible association and the impact of
      epilepsy and epileptiform activity in children with SLI.
    

Detailed description: 
      This study concentrates on the impact of epileptiform activity for childhood epilepsy on the
      speech and language disturbances in addition to the associated social, cognitive and
      intellectual dysfunctions.
    

Intervention name(s): EEG was recorded by EEG Machines
Intervention type(s): Diagnostic Test
Intervention description(s): EEG was recorded by EEG Machines
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The study was conducted on 80 children with speech disorders in preschool children.
Communicating Multiple Disease Risks
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Epidemiology seeks to improve public health by identifying risk factors for cancer and other
      diseases and conveying that information to relevant audiences. The audience is presumed to
      understand and use that information to make appropriate decisions about lifestyle behaviors
      and medical treatments. Yet, even though a single risk factor can affect the risk of multiple
      health outcomes, this information is seldom communicated to people in a way that optimizes
      their understanding of the importance of engaging in a single healthy behavior. Providing
      individuals with the ability to understand how a single behavior (obtaining sufficient
      physical activity) could affect their risk of developing multiple diseases could foster a
      more coherent and meaningful picture of the behavior's importance in reducing health risks,
      increase motivation and intentions to engage in the behavior, and over time improve public
      health.

      The proposed study translates epidemiological data about five diseases that cause significant
      morbidity and mortality (i.e., colon cancer, breast cancer (women), heart disease, diabetes,
      and stroke) into a visual display that conveys individualized risk estimates in a
      comprehensible, meaningful, and useful way to diverse lay audiences.
    


Intervention name(s): Cognitive interview; Survey
Intervention type(s): Behavioral; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Healthy Volunteers
The Use of Cannabidiol (CBD) in Pain Reduction and Opioid Use After Shoulder Arthroscopy
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study is designed to evaluate the effects of administering CBD to control post-operative
      pain in patients undergoing shoulder arthroscopy. Secondly, the purpose will be to evaluate
      the effectiveness of CBD in comparison with opioid therapy for post-operative pain.
    


Intervention name(s): CBD Oral Disintegrating Tablet (ODT); Placebo ODT
Intervention type(s): Drug; Other
Intervention description(s): Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen; Cohort 2 will not receive CBD; but a visually indistinguishable placebo ODT instead.
The resident physician, physician assistant, anesthesiologist, surgeon and study team members will remain blinded. Additionally, all patients will receive a traditional upper extremity interscalene block as per routine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Chronic Beta2-adrenergic Stimulation and Cardiac and Skeletal Muscle Hypertrophy
Condition: Muscle Hypertrophy in Healthy Young Men
MeSH terms: Hypertrophy
Study type: Interventional

Summary: 
      Studies in animals have shown that beta2-adrenoceptor activation with selective agonists
      regulates protein metabolism and muscle growth in skeletal and cardiac muscle tissue. These
      effects may be mediated by cAMP/PKA dependent activation of several downstream sites that
      modulate protein synthesis and breakdown. While the role of beta2-adrenoceptor signaling is
      well-described in animals, it is inadequately explored in humans. The purpose of the study is
      thus to investigate the effect of chronic beta2-adrenergic stimulation (cAMP/PKA-signaling)
      on muscle hypertrophy.
    


Intervention name(s): Salbutamol; Placebo; Resistance training
Intervention type(s): Drug; Drug; Other
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
SarCNU in Treating Patients With Recurrent Malignant Glioma
Condition: Brain and Central Nervous System Tumors
MeSH terms: Glioma; Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of sarCNU in treating patients who have
      recurrent malignant glioma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the efficacy of SarCNU, in terms of objective response and duration of
           response, in patients with recurrent malignant gliomas.

        -  Determine the qualitative and quantitative toxic effects of this drug in these patients.

        -  Determine the time to progression and survival of patients treated with this drug.

      OUTLINE: This is a multicenter study.

      Patients receive oral SarCNU on days 1, 5, and 9. Treatment repeats every 6 weeks for up to 4
      courses in the absence of disease progression or unacceptable toxicity.

      Patients are followed at 4 weeks and then every 3 months thereafter.

      PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 12-18
      months.
    

Intervention name(s): SarCNU
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent adult brain tumor; adult glioblastoma; adult anaplastic astrocytoma; adult giant cell glioblastoma; adult gliosarcoma
Novel Diagnostics and Probiotics to Improve Management of Paediatric Acute Gastroenteritis
Condition: Acute Gastroenteritis
MeSH terms: Gastroenteritis
Study type: Interventional
Phase: Phase 4

Summary: 
      Many children admitted to hospital in Botswana without bloody diarrhoea are presumed to have
      viral gastroenteritis and so not treated with antibiotics - but they may indeed have a
      treatable cause for their illness. We will conduct a randomized trial to see if rapid testing
      using novel methods to identify potentially treatable causes of diarrhoea leads to improved
      outcomes. We will also be randomizing children to probiotic therapy versus placebo (the
      standard of care) to see if this treatment decreases the duration of diarrhoea. The proposed
      study is a pilot trial, necessary before embarking on a large multi-centre trial.
    


Intervention name(s): Rapid diagnostic; Probiotic; Placebo
Intervention type(s): Other; Dietary Supplement; Other
Intervention description(s): Specimens from rectal mucosa will be obtained using flocked swabs at enrolment. Those in 'rapid diagnostic' groups will have them tested using multiplex PCR the day of enrolment and participants with treatable pathogens will have antimicrobials provided. Those in 'delayed diagnostic' groups will have the swabs batched at tested at the conclusion of the study, being treated as per standard of care.; Lactobacillus reuteri suspended in vegetable oil, 5 drops/day (1 x 10e8 CFU) x 2 months; Identical in appearance to L. reuteri probiotic (same bottle), but simply vegetable oil. Dose is 5 drops/day x 2 months.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diarrhoea; gastroenteritis; rapid diagnostics; probiotics; sub-Saharan Africa
Verify if Amelogenins Had Some Benefits in Improving Lower 2nd Molar Periodontal Healing After 3rd Molar Extraction
Condition: Attachment Loss, Periodontal; Teeth, Impacted
MeSH terms: Tooth, Impacted; Periodontal Attachment Loss
Study type: Interventional
Phase: Phase 4

Summary: 
      Background: Prevention of periodontal defects after the extraction of lower third molars
      remains a challenge. Various methods have been proposed in the literature, but there are no
      studies which evaluated the effectiveness of amelogenins.

      Methods: A single-blind split-mouth randomized controlled clinical trial (RCT) was performed
      on 5 patients to verify if amelogenins had some benefits in improving lower second molar
      periodontal healing after adjacent third molar extraction. A PPD ≥ 8 mm associated with a
      radiographic bone defect of at least 5 mm were the main inclusion criteria.
    


Intervention name(s): Amelogenin; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): amelogenins applied on the distal surface of the lower second molar after adjacent third molar extraction; placebo applied on the distal surface of the lower second molar after adjacent third molar extraction
Other intervention name(s): third molar surgery; third molar surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized, split-mouth, placebo-controlled, single blind clinical trial, a pilot study
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: third molar surgery; amelogenin; periodontal pocket
Impact of Home Zinc Treatment for Acute Diarrhea in Children
Condition: Diarrhea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      Background. Zinc deficiency is common in Africa. It has been shown in Asia that zinc as
      treatment for diarrhea can shorten the course of episodes of diarrhea, as well as prevent
      future episodes. The use of zinc at home to treat diarrhea in an African setting, where
      malaria, HIV and malnutrition are common, has not been well-studied.

      Objective. To evaluate if zinc treatment for diarrhea given at home in Kenyan children will
      decrease the community prevalence of diarrhea more than zinc given only in the clinic Work
      planned. We propose to do a community-randomized intervention study of 10 days of dispersible
      zinc tablets given in the home, in addition to ORS, to treat diarrhea in children under-5
      years of age living in a rural part of Bondo District. The comparison group will be children
      who receive zinc and ORS in the clinic only. The primary outcome will be a comparison of the
      prevalence of diarrhea in home zinc versus nonhome zinc villages. Secondary outcomes will be
      the incidence of repeat episodes of diarrhea, the duration of diarrheal illness, the
      prevalence of acute respiratory infection, and the effect of malaria infection on treatment
      with zinc. Thirty-three villages (approximately 1300 children) will be enrolled and children
      will be followed for 1 year.

      Significance of results. If this study shows zinc given at home to be effective, this might
      be considered by the Kenyan MOH as an essential component of the treatment of diarrhea in
      children at the community level.
    


Intervention name(s): zinc
Intervention type(s): Drug
Intervention description(s): 10 day blister pack of 20 mg zinc disperable tablets, 1 tablet qd for children 6 months to 4 years, 1/2 tablet qd for children 2-5 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diarrhea; zinc; oral rehydration therapy