bioihbjkbjnl/mcl2 huggingface dataset:
Infection Rates Following Internal Fixation of Open and Closed Tibia Fractures in India
Condition: Tibia Fracture
MeSH terms: Infections; Fractures, Bone; Tibial Fractures
Study type: Observational

Summary: 
      The objectives of this study are to investigate infection rates and management for open and
      closed tibia fracture subjects in India treated with internal fixation. These objectives will
      be carried out by answering the following questions:

        1. What is the infection rate within one year of surgery for open and closed tibia fracture
           subjects in India treated with internal fixation?

        2. What is the distribution of infection per type of infection, stratified by time (early,
           delayed, late) and location (superficial or deep) in open and closed tibia fracture
           subjects in India treated with internal fixation?

      Secondary objectives

        1. How are infections managed in open and closed tibia fracture subjects in India treated
           with internal fixation?

        2. What is the treatment outcome for open and closed tibia fracture subjects in India
           treated with internal fixation?

        3. What is the influence of the following clinic and subject factors on the occurrence of
           infection within one year for open and closed tibia fracture subjects in India treated
           with internal fixation?

             1. Hospital standard hygienic and antibiotic protocol for infection prevention

             2. Subject demographics

             3. Time between injury and surgery and between admission and surgery

             4. Fracture type (AO Müller classification)

             5. Soft tissue damage (according to the Tscherne classification for closed fractures
                or Gustilo classification for open fractures)

             6. Fracture management and implant type

             7. Surgical details such as duration of surgery

        4. Is there a difference in health-related quality of life as measured by the EuroQol-5
           Dimensions (EQ-5D) between subjects with and without infections?

        5. Is there a difference in the number of complications not related to infection (adverse
           events and serious adverse events) between subjects with and without infections?
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with open or closed tibia fractures
      
Keywords: Infection; Open tibia fractures; Closed tibia fractures; Wound infection
Sulfasalazine and Endothelial Function
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      Experimental studies suggest that systemic inflammation leads to endothelial dysfunction and
      atherosclerosis. This study will examine the effects of the anti-inflammatory drug
      sulfasalazine on endothelial function in patients with coronary artery disease. Subjects will
      be treated with sulfasalazine or to placebo for six weeks. After a two-week rest period,
      subjects will cross over to the alternative treatment. Endothelium-dependent flow-mediated
      dilation of the brachial artery will be studied before and after each drug. We hypothesize
      that anti-inflammatory therapy will reverse endothelial dysfunction in patients with coronary
      artery disease.
    


Intervention name(s): Sulfasalazine
Intervention type(s): Drug
Intervention description(s): sulfasalazine 2 grams daily for 6 weeks
Intervention MeSH terms: Sulfasalazine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Open-Label Pharmacokinetics (PK)/Safety Study of Luliconazole Solution, 10% in Distal Subungual Onychomycosis
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To determine the safety, tolerability, systemic exposure and pharmacokinetics of luliconazole
      after repeat daily topical application of Luliconazole Solution, 10% in a maximal use setting
      in adults with distal subungual onychomycosis of the toenails.
    


Intervention name(s): Luliconazole Solution, 10%
Intervention type(s): Drug
Intervention description(s): 28 days of daily application
Intervention MeSH terms: Luliconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Toenail; Fungal Infections; DSO
The Effect of Ethinyl Estradiol on Polycystic Ovary Syndrome Women Undergoing Intrauterine Insemination
Condition: Infertility
MeSH terms: Polycystic Ovary Syndrome; Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      According to the studies CC is successful at inducing ovulation in 50%-75% of cases, but only
      30-40% becomes pregnant. The difference has been attributed to a negative action of clomifen
      citrate(CC) in the form of prolonged antiestrogenic effects on endometrial receptivity. For
      avoiding of these negative effects, giving ethinyl estradiol in sufficient dosages may be
      effective. The purpose of this study is comparing pregnancy rates after IUI in women who use
      CC alone and those who use CC in combination with ethinyl estradiol
    

Detailed description: 
      The proposal of This study approved by our institutional review boards and institution's
      ethical committee, and all Participants will sign a written consent before enter to study.
      All patients will be randomly divided into two groups, A and B. Stimulation will begin on day
      3 with the administration of 100 mg of clomifen citrate(CC) daily for 5 days. On day 8,
      ethinyl estradiol will be given daily for 5 days in group A and placebo will be given for 5
      days in group B. Plasma levels of estradiol(E2), Luteinizing hormone (LH) and
      Follicle-stimulating hormone (FSH) will be evaluated on days 3 and 13 of the menstrual cycle.
      Ultrasound examination will be done on days 3, 13 and days of HCG administration and IUI for
      determining of endometrial thickness, number of follicles and size of the dominant follicle.

      When the diameter of at least one follicle reached equal or greater than 18 mm, human chronic
      gonadotrophin (HCG) 10,000 IU will be administered.

      The pulsatility index also will be recorded in both uterine arteries on day of HCG
      administration. A single IUI will be performed 24-36 hours after the administration of hCG.
      Pregnancy will be confirmed by increasing level of concentration of serum βHCG which will be
      assessed 14 days after IUI
    

Intervention name(s): clomiphene citrate with ethinyl esteradiol; clomiphene citrate with plasebo
Intervention type(s): Drug; Drug
Intervention description(s): Clomiphene citrate is used in combination of ethinyl estradiol (0.05 mg for 5 days) for induction ovulation of polycystic ovary syndrome women undergoing intrauterine insemination; Clomiphene citrate is used in combination of placebo (for 5 days) for induction ovulation of polycystic ovary syndrome women undergoing intrauterine insemination
Other intervention name(s): Drug Administration; Drug administration
Intervention MeSH terms: Citric Acid; Sodium Citrate; Clomiphene; Enclomiphene; Zuclomiphene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ethinyl estradiol; Polycystic ovary syndrome; Intrauterine insemination
Respiratory Training in Patients With Leukemia
Condition: Leukemia
MeSH terms: Leukemia
Study type: Interventional

Summary: 
      Forty male leukemic patients receiving chemotherapy were selected from National Cancer
      Institute, They were randomly assigned into two groups. Group (A) included 30 patients who
      were trained by Inspiratory muscle trainer for 4 weeks ;5 sessions/week and Group (B)
      included 10 patients as a control group.

      The following measures were taken before and after the study period : Maximum voluntary
      ventilation(MVV) , 2 min walk test, FACT-G questionnaire
    

Detailed description: 
      Forty male leukemic patients receiving chemotherapy for at least one cycle and their mean
      ages 37.1 ± 4.89 years.The patients were selected from National Cancer Institute, Cairo (
      inpatient ward). The study lasted from March 2018 to June 2018. Patients were randomly
      assigned into two groups.Group A (30 patients) who received inspiratory muscles training for
      4 successive weeks, 5 sessions/week; and Group B (10 patients) acted as a control group on
      chemotherapy only. Data obtained from both groups regarding (MVV), 2 min walk test and
      Quality of life questionnaire (FACT-G) were statistically analyzed and compared
    

Intervention name(s): respiratory training
Intervention type(s): Other
Intervention description(s): Respiratory training was done by using threshold inspiratory muscle trainer(Respironics, New Jersey , USA, No.8373-0730)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: leukemia; chemotherapy; respiratory training
Preoperative Intravesical Electromotive Mitomycin-c for Primary Non-muscle Invasive Bladder Cancer
Condition: Superficial Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Early single instillation of chemotherapy after TUR is recommended in the European
      Association of Urology Guidelines. Nevertheless, the procedure is suboptimal for patients
      with multiple tumors, sometimes is not tolerated and it can results in severe complications.
      In both laboratory and clinical studies, intravesical electromotive drug administration
      (EMDA) increases mitomycin-C (MMC) bladder uptake, resulting in an improved clinical efficacy
      in non-muscle invasive bladder cancer (NMIBC). The investigators will compare the effects of
      one immediate pre-TUR intravesical EMDA/MMC instillation with one immediate post-TUR
      intravesical passive diffusion MMC (PD/MMC) instillation and TUR alone in patients with
      NMIBC.

      All eligible patients with primary NMIBC will be randomized into 3 groups who will undergo
      transurethral resection alone (TUR/alone); TUR plus single immediate postoperative
      instillation (immediately after TUR) of 40 mg PD/MMC with a dwell time of 60 minutes; or
      single immediate preoperative instillation (immediately before TUR) of 40 mg EMDA/MMC with 20
      mA electric current for 30 minutes. Patients with intermediate and high risk NMIBC will
      undergo adjuvant intravesical therapy. The primary end points will be the recurrence rate and
      disease-free interval. All clinical analyses will be performed on an intent to treat basis.
    


Intervention name(s): Mitomycin-C 40 mg
Intervention type(s): Drug
Intervention description(s): Intravesical instillation of Mitomycin-C
Other intervention name(s): Mytomicin-C Kyowa Italiana Farmaceutici Milano
Intervention MeSH terms: Mitomycins; Mitomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: intravesical chemotherapy; early single instillation; mitomycin-C; electromotive drug administration
Mindfulness and Neural Cardiovascular Control in Humans
Condition: Elevated Blood Pressure
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      This study evaluates the impact of mindfulness-based stress reduction (MBSR) on sympathetic
      nerve activity and arterial stiffness. The investigator's central hypothesis is that MBSR
      will reduce sympathetic activity and arterial stiffness.
    

Detailed description: 
      This study will recruit male and female subjects with elevated blood pressure who will
      participate in a randomized, active control study to examine the impact of mindfulness-based
      stress reduction (MBSR) on blood pressure, muscle sympathetic nerve activity and arterial
      stiffness. The study will utilize established techniques for assessing blood pressure
      patterns (24-hour ambulatory monitoring), peripheral sympathetic activity (microneurography)
      and vascular stiffness (applanation tonometry) in humans. This study includes a stress
      management education class for the active control.
    

Intervention name(s): Stress Management
Intervention type(s): Behavioral
Intervention description(s): An eight week stress reduction course.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Biomarkers of Metabolic Syndrome and Prediabetes
Condition: Metabolic Syndrome; Diabetes; Prediabetes; Hypertension
MeSH terms: Hypertension; Metabolic Syndrome; Prediabetic State; Glucose Intolerance; Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to investigate the feasibility of using salivary biomarkers to
      screen for complications of metabolic syndrome including prediabetes.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        community sample
      
Biospecimen description: 
      saliva
    
Keywords: salivary biomarker; metabolic syndrome; prediabetes; diabetes hypertension
Hypothermia for Encephalopathy in Low Income Countries-Feasibilty
Condition: Neonatal Encephalopathy
MeSH terms: Brain Diseases; Hypothermia
Study type: Interventional

Summary: 
      Whole body cooling improves survival with normal neurological outcome after neonatal
      encephalopathy in high-income countries. However, cooling equipments used in the high-income
      countries are expensive and unsuitable for wider use in low and middle-income countries
      (LMIC). We had previously conducted a randomised controlled trial of whole body cooling using
      phase changing material in south India. Although cooling was provided, there were wide
      temperature fluctuations.

      Aim: To examine efficacy of the low technology cooling equipment (Tecotherm-HELIX) in
      administering effective and stable whole body cooling in encephalopathic infants.

      Methods: After informed parental consent (and ethical approvals), we will administer 72 hours
      of whole body cooling (rectal temperature 33 to 34C) to a total 50 encephalopathic infants
      (aged <6 hours) admitted to the neonatal units at Calicut Medical College and Madras Medical
      College, over a six month period. To induce cooling, the infants will be kept on the cooling
      mattress. Temperature will be continuously measured for 80 hours using a rectal probe
      connected to a digital data logger.

      The primary outcome will be the effective cooling time i.e. percentage of time (95% CI) for
      which the temperature remains between 33 to 340C during the intended cooling period.
    


Intervention name(s): Tecotherm-HELIX
Intervention type(s): Device
Intervention description(s): Whole body cooling using Tecotherm-HELIX
Other intervention name(s): Therapeutic hypothermia; Whole body cooling
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Encephalopathy, Newborn, Low and Middle-income countries, Hypothermia
Comparison of Two NN5401 Formulations Versus Biphasic Insulin Aspart 30, All in Combination With Metformin in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (Soluble
      Insulin Analogue Combination [SIAC], insulin degludec/insulin aspart) formulations with each
      other and with biphasic insulin aspart 30, all in combination with metformin in insulin naive
      subjects with type 2 diabetes.
    


Intervention name(s): insulin degludec/insulin aspart; insulin degludec/insulin aspart; biphasic insulin aspart; metformin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Formulation B: Treat-to-target dose titration scheme, injection s.c., twice daily; Formulation B: Treat-to-target dose titration scheme, injection s.c., twice daily; Treat-to-target dose titration scheme, injection s.c., twice daily; Tablets, 1500-2000 mg/daily
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Biphasic Insulins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase 3 Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional
Phase: Phase 3

Summary: 
      This clinical study will evaluate pilocarpine hydrogen chloride (HCl) ophthalmic solution
      (AGN-190584) in an expanded participant population to establish efficacy, safety, and
      tolerability versus the vehicle-control when administered, over a 30-day study intervention
      period, once daily bilaterally in participants with presbyopia.
    


Intervention name(s): Pilocarpine HCl Ophthalmic Solution; Vehicle
Intervention type(s): Drug; Other
Intervention description(s): Pilocarpine HCl ophthalmic solution 1.25%, one drop in each eye, once daily, for up to 30 days.; Vehicle, one drop in each eye, once daily, for up to 30 days.
Other intervention name(s): AGN-190584; VUITY
Intervention MeSH terms: Ophthalmic Solutions; Pilocarpine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Probiotics and Oxytocin Nasal Spray on Social Behaviors of Autism Spectrum Disorder (ASD) Children
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      Because oral probiotics reported to potentially induce endogenous Oxytocin, and Oxytocin has
      been reported to improve social behaviors, the investigators will conduct a pilot trial to
      compare the effects of probiotics and Oxytocin on social behavioral changes in ASD children.
      Additionally, the investigators will check oxytocin levels, and perform brain fMRI in some
      subjects, in order to determine which treatment is more efficient, sustainable, and
      practical, and whether both treatments in combination are better than either treatment alone.
      If the trial is conclusive, the investigators will conduct a trial in large scale to
      understand more the mechanism of ASD behaviors and corresponding effective interventions.
    

Detailed description: 
      This study description is in accordance with the Consolidated Standards of Reporting Trials
      (CONSORT) guidelines that are published for the evaluation of randomized controlled trials.
      This clinical trial is a randomized, double-blind placebo controlled study. Subjects will be
      randomized to 2 groups:

      Phase 1: a. oral placebo, and b. oral probiotics; Phase 2: a. intranasal Oxytocin(OXT) + oral
      placebo, and b. intranasal OXT + oral probiotics

      The treatment will proceed for a total of 28 weeks. In the first phase (16 weeks), all the
      patients will be randomly and proportionally divided into two groups: Group A (30 subjects)
      receives oral probiotics while Group B (30 subjects) receives an oral placebo. In the second
      phase, subjects in Group A and Group B will continue their respective oral probiotics or
      placebo administration as in Phase 1. In addition, both groups will be simultaneously
      administered with intranasal OXT spray.

      Testing will be performed 3 times total (before, during, and after treatment). The tests
      include behavioral surveys, cognitive tests, clinical autonomic tests, and blood tests for
      oxytocin levels. Investigators plan to select up to 10 subjects from each group to conduct a
      series of MRI studies at week 0, week 16 and week 28.
    

Intervention name(s): intranasal oxytocin; oral probiotics; oral placebo
Intervention type(s): Drug; Dietary Supplement; Dietary Supplement
Intervention description(s): 4-24 IU per day, dosage gradually increases; 200 million cfu per day; 2 pills per day
Other intervention name(s): Novartis Syntocinon
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase 1: a. oral placebo, and b. oral probiotics; Phase 2: a. intranasal OXT + oral placebo, and b. intranasal OXT + oral probiotics
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Probiotics, Oxytocin
Live Well: A Practical and Effective Low-Intensity Dietary Counseling Intervention for Use in Primary Care Patients With Dyslipidemia
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate the effects on lipids and diet of a low-intensity
      dietary counseling intervention provided by the primary care physician (PCP), in patients at
      risk for cardiovascular diseases
    

Detailed description: 
      The objective of this study is to design and evaluate the feasibility and the effect on diet
      quality and blood lipids a new dietary counseling intervention that will be sustainable in
      the "real-world" settings of the current clinical practice. The intervention will be
      initiated by the primary care physician during the routine office visits and will use paper
      and web-based counseling materials. Internet based healthcare, or e-healthcare, is a consumer
      focused health care delivery paradigm that physicians and the healthcare system can no longer
      ignore. Lifestyle counseling and preventive medicine are potentially ideal areas of patient
      care that could be provided efficiently through this emerging venue of healthcare delivery.
      Internet access is near-universal for Americans under the age of 60: 90% of 18-29 year-olds,
      85% of 30-49 year-olds, and 70% of 50-64 year-olds.

      The aims of this study are: 1) - develop a patient self-administered, computerized version of
      the paper-based Rate-your-Plate dietary screening Questionnaire; 2) - create counseling
      materials on diet and cholesterol and build a secure, HIPAA compliant, interactive web-based
      counseling application that will allow patients to receive personalized counseling base on
      the results of the screening dietary questionnaire and the goals chosen by the patients; 3) -
      to test the feasibility of this intervention in the clinical settings of primary care, and
      evaluate its effect on lipids panel at 3 and 6 months .
    

Intervention name(s): Group A: Dietary counseling month 0-6 Group B: Dietary counseling month 3-6
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diet counseling; primary care