bioihbjkbjnl/mcl2 huggingface dataset:
Iron Repletion in Chronic Cough and Iron Deficiency
Condition: Cough; Laryngeal Disease; Bronchial Disease; Iron Deficiency
MeSH terms: Cough; Bronchial Diseases; Laryngeal Diseases; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      Chronic cough is more frequent and severe in women than in men. Women often have decreased
      iron stores, due to menses and pregnancies. Aim of the study: to investigate if iron
      deficiency has a role in chronic cough by favouring airway hypersensitivity to inhaled
      irritants.
    

Detailed description: 
      Women with chronic cough and iron deficiency, cough unresponsive to empiric treatment
      (suggested by cough guidelines) with antiH1-histaminic drug plus proton pump inhibitor.

      Cough VAS (score from 1,best, to 5, worst). Histamine inhalation challenge, performed to
      assess bronchial, laryngeal, and cough thresholds, performed by delivering doubling
      concentrations, from 0.5 mg/ml up to 32 mg/ml, by a nebulizer. After each dose FEV1, as
      bronchial index, maximum mid-inspiratory flow (MIF50) as laryngeal index, and coughs number
      are assessed. Bronchial threshold is the concentration causing 20% decrease in FEV1,
      laryngeal threshold that causing 25% decrease in MIF50, cough threshold that causing 5
      coughs. Histamine hyperresponsiveness of the bronchi (BHR), larynx (LHR) and cough (coughHR)
      are defined for thresholds equal or below 8 mg/ml.

      Histamine thresholds and cough VAS obtained in baseline, after cough empiric treatment with
      antiH1-histaminic and proton pump inhibitor, and after iron supplementation.
    

Intervention name(s): iron sulphate; antiH1-histamine, proton pump inhibitor
Intervention type(s): Drug; Drug
Intervention description(s): 1 or 2 330 mg/daily iron sulphate oral tablets; This is not an intervention of interest, but it is a selection criterion to define unexplained cough, as suggested by cough guidelines.
Other intervention name(s): AntiH1-histaminic drug = Loratadine 10 mg; Proton pump inhibitor = omeprazole 20 mg twice daily
Intervention MeSH terms: Loratadine; Omeprazole; Proton Pump Inhibitors; Histamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cough; Laryngismus; Bronchial spasm; Deficiency diseases
A Study of RO5028442 in Adult Male High-Functioning Autistic Patients
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This multi-center, randomized, double-blind study will evaluate exploratory biomarkers and
      the safety and tolerability of a single dose of RO5028442 in adult male high-functioning
      autistic patients. In a cross-over design, patients will be randomized to receive either a
      single dose of RO5028442 or matching placebo with a washout period of 7-14 days. Anticipated
      time on study is up to approximately 9 weeks.
    


Intervention name(s): Placebo; RO5028442
Intervention type(s): Drug; Drug
Intervention description(s): Single dose; Single dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Safety and Efficacy of Juvederm® VOLUMA™ for Correction of Mid-face Volume Deficiency
Condition: Mid-face Volume Deficiency
Study type: Interventional

Summary: 
      This is a prospective, open-label experience study to be conducted at 6 clinical sites in
      Australia, with the objective to collect efficacy and safety information for Juvederm®
      VOLUMA™ when used for volumising the mid-face and cheek area.
    


Intervention name(s): Cross-linked hyaluronic acid gel
Intervention type(s): Device
Intervention description(s): Cross-linked hyaluronic acid gel (Juvederm® VOLUMA™) up to 4 mLs injected in each side of the face.
Other intervention name(s): Juvederm® VOLUMA™
Intervention MeSH terms: Hyaluronic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the safety and efficacy of natalizumab in the
      treatment of individuals who have been diagnosed with relapsing remitting multiple sclerosis
      (MS). It is hoped that natalizumab will prevent certain types of white blood cells from
      moving out of the bloodstream into organs, including the brain, that are being damaged by
      autoimmune disease (a disease in which the body's own immune system attacks certain organs).
      These white blood cells are thought to cause inflammation that can result in lesions (small
      areas of damage) in the brain. These lesions are thought to be the cause of relapses and
      disability in MS.
    


Intervention name(s): Natalizumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Natalizumab 300 mg IV infusion, every 4 weeks, for up to 116 weeks.; Placebo, IV infusion, every 4 weeks, for up to 116 weeks.
Other intervention name(s): Tysabri
Intervention MeSH terms: Natalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Relapsing Remitting Multiple Sclerosis
Aerosol BCG Challenge Trial in Healthy UK Adults
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      TB041 is a clinical challenge trial primarily to evaluate the safety of BCG challenge
      administered by the aerosol inhaled route in healthy, BCG naive UK adults. The trial will
      also look to evaluate and compare the amount of BCG recovered from the lungs and from the
      skin, following challenge by either the aerosol or the intradermal route.
    

Detailed description: 
      Mycobacterium tuberculosis (M.tb) is a pathogen found worldwide that infects humans causing
      tuberculosis (TB), a transmissible disease resulting in very high mortality and morbidity. It
      is estimated that a third of the world's population is latently infected with M.tb, and these
      people carry a 10% lifetime risk of developing active life-threatening disease. In 2013,
      there were 9 million new cases worldwide and 1.5 million people died of TB. Co-infection with
      human immunodeficiency virus (HIV) greatly increases risk of TB reactivation and death. TB
      diagnosis is challenging and drug treatment can be prolonged, harmful, costly and complex.
      For these reasons an effective vaccine is a global public health priority.

      Currently to assess vaccine efficacy against TB there is no reliable alternative to large,
      randomized controlled trials. These efficacy trials for novel TB vaccines are challenging,
      time consuming and very costly. For other diseases, such as malaria, challenge studies have
      been informative. The development of a safe controlled human mycobacterial challenge model
      which would ultimately be validated against field efficacy studies could greatly facilitate
      TB vaccine development by being a guide for selecting which candidate TB vaccines to take
      forwards to large efficacy trials.

      TB041 is a clinical challenge trial primarily to evaluate the safety of BCG challenge
      administered by the aerosol inhaled route in healthy, BCG naive UK adults. The trial will
      also look to evaluate and compare the amount of BCG recovered from the lungs and from the
      skin, following challenge by either the aerosol or the intradermal route.
    

Intervention name(s): BCG; Saline placebo; BCG
Intervention type(s): Biological; Other; Biological
Intervention description(s): BCG SSI (Due to a global shortage of BCG SSI, BCG Bulgaria used in Group 2); Saline placebo; BCG Bulgaria (InterVax)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: BCG; Aerosol; Tuberculosis; Challenge
Smartphone App for Asthma Self-care: Assessment of Outcomes (Asthma Progession and Costs)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The goal of this clinical trial is to investigate whether a smartphone app based on the
      Global Initiative for Asthma (GINA) guidelines can improve asthma control and quality of
      life, and decrease asthma-related costs in children. The main question it to answer whether
      this app can improve asthma control, increase the quality of life, and decrease
      asthma-related costs.

      Participants in the intervention group downloaded the asthma smartphone app, and followed up
      monthly via phone calls and clinic visits, while the control group received reminder calls.
      Researchers will compare with the control group to see if the intervention receives more
      asthma control improvement.
    


Intervention name(s): Smartphone Apps
Intervention type(s): Device
Intervention description(s): The intervention group downloaded the asthma smartphone app, and followed up monthly via phone calls and clinic visits
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Smartphone selft-care system; asthma control; medical cost; emergency room visit; hospital admission
Sodium Intake in Ecuadorian Population
Condition: Dietary Habits; Risk Factor, Cardiovascular; Nutritional Disorder
MeSH terms: Nutrition Disorders
Study type: Observational

Summary: 
      This study is aim to determine the sodium intake in Ecuadorian population that is an unknown
      information at present. For that, 24h urine samples will be collected from 130 subjects
      working either at tue USFQ or HDLV to measure sodium excretion.
    


Intervention name(s): Urinary sodium excretion
Intervention type(s): Diagnostic Test
Intervention description(s): Urinary sodium and potassium were measured using the Ion-Selective Electrode (ISE) indirect Na-K-Cl for Gen.2 (Roche Diagnostic, Switzerland).
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Will be enrolled a sample of 178 adults aged 25 to 64 years. The research team, who have
        faculty appointments in USFQ, supervised the collection of the urine samples. We invited a
        broad spectrum of employees (which included health care workers, professors, and custodial
        staff) from both institutions to participate in the study.
      
Biospecimen description: 
      Urine
    
Keywords: Sodium intake; Urinary sodium excretion
Two Different Regimens of Misoprostol in Retained Placenta
Condition: Postpartum Haemorrhage; Retained Placenta
MeSH terms: Postpartum Hemorrhage; Placenta, Retained; Hemorrhage
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates intra umbilical vein injection of 800 µg versus 400 µg misoprostol for
      the treatment of retained placenta to reduce the need of manual removal of placenta under
      general anaesthesia
    

Detailed description: 
      The third stage of labor may be complicated by retained placenta, which may cause severe
      bleeding and infection, with a potentially fatal outcome. Manual removal of placenta is the
      current standard of management of retained placenta which usually requires general or
      regional anaesthesia at a hospital and it is an invasive procedure that may lead to bleeding,
      trauma and infection. Intraumbilical injection of uterotonic agent( misoprostol) is an easy,
      non invasive procedure. A randomized clinical trial are required to determine the difference
      between two doses of misoprostol 400 versus 800 micro gram for management of retained
      placenta
    

Intervention name(s): Misoprostol
Intervention type(s): Drug
Intervention description(s): 2 regimes of misoprostol 400 microgram and 800 microgram injections used for 2 groups of women
Other intervention name(s): Cytotic
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Retained placenta; Misoprostol; double blind; Randomization; Haemorrhage
Phase IV Study to Evaluate the Effects of Statin Monotherapy or Statin / Ezetimibe Combination Therapy on Hepatic Steatosis in Patients With Hyperlipidemia and Nonalcoholic Fatty Liver Disease
Condition: Nonalcoholic Fatty Liver Disease; Dyslipidemias
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate the therapeutic effect of ezetimibe on nonalcoholic fatty liver disease, the
      effect of rosuvastatin 5mg monotherapy and rosuvastatin 5mg / ezetimibe 10mg combination
      therapy n patients with hyperlipidemia and fatty liver will be compared and analyzed.

      This study included a total of 70 patients (35 per subgroup) for randomized controlled trials
      with prospective, open label, randomized, single-institution clinical trials.

      The drug will be maintained for a total of six months. The primary endpoint is the difference
      of liver fat change measured by MRI-PDFF in colocalized regions of interest within nine liver
      segments between two groups.
    


Intervention name(s): Rosuvastatin; Rosuvastatin/ezetimibe combination
Intervention type(s): Drug; Drug
Intervention description(s): Rosuvastatin 5mg 1T daily for 6 months; Rosuvastatin 5mg / Ezetimibe 10mg combination 1T daily for 6 months
Intervention MeSH terms: Rosuvastatin Calcium; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study will conduct to evaluate the efficacy of liver fat lowering and safety of rosuvastatin 5mg alone or in combination with rosuvastatin 5mg / ezetimibe 10mg for 6 months.
Masking: None (Open Label)
Primary purpose: Treatment
Tonabersat in the Prophylaxis of Migraine With Aura
Condition: Migraine With Aura
MeSH terms: Migraine Disorders; Migraine with Aura
Study type: Interventional
Phase: Phase 2

Summary: 
      Overall trial objectives:

        1. Can treatment with tonabersat reduce the number of days with aura and/or migraine
           headache in patients with migraine with aura

        2. How well tolerated is treatment with tonabersat

      The study is based on the hypothesis that the unique mechanism of action of tonabersat will
      inhibit some of the early events in the generation of aura and migraine headache and so be
      effective as prophylactic treatment
    


Intervention name(s): Tonabersat; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): two tablets once daily; two tablets once daily
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Erector Spinae Plane Block in Renal Transplantation Donors
Condition: Renal Transplantation; Laparoscopic Nephrectomy; Erector Spinae Plane Block
Study type: Interventional

Summary: 
      Erector Spina Plan Block (ESPB) is a relatively new, easy-to-apply and safe regional
      anesthesia technique used to provide postoperative analgesia in various surgeries. Studies
      showing the clinical benefits of Erector Spina Plan block in renal transplantation surgery
      are limited to case reports. In this study, the effect of Erector Spina Plan Block on opioid
      consumption in postoperative period on donor patients who will undergo laparoscopic
      nephrectomy in renal transplantation surgery will be examined prospectively.

      The aim of the study is to provide analgesia to donor patients using less opioids by Erector
      Spina Plan Block and provide enhanced recovery.
    


Intervention name(s): Erector Spinae Plane Block; Intravenous fentanyl patient control device
Intervention type(s): Procedure; Procedure
Intervention description(s): Erector Spinae Plane Block will be administered before the surgery.; 24-hour fentanyl consumption will be recorded.
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Laparoscopic Nephrectomy; Erector Spinae Plane Block
Aerobic Exercise on Fitness Score and Blood Glucose Level in Adolescents Girls With Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      In adolescent diabetic girls, a correct life style, including diet and physical activity, is
      part of a correct intervention protocol. Thus, the aim of this study was to evaluate the
      effects of aerobic training intervention, based on heart rate at glycemic level , on clinical
      and physiological parameters in adolescent girls with type 1 diabetes forty type1 DM girls
      will randomly assigned to an intervention (study group ) or control group. The study group
      will perform a supervised aerobic exercise training based on heart rate whereas control group
      maintained their usual lifestyle. Anthropometric fitness score measures, blood analysis will
      assess at baseline and after intervention.
    

Detailed description: 
      fourty adolescents girls were diagnosed by physician as having type 1 diabetes mellitus and
      recruited from outpatient internal of El-Hussien hospital in Egypt . girls ages were between
      13 and 18yr old; . The following inclusion criteria was applied to all participants in the
      study : all girls had type 1DM for more than 3 years, Their dose of insulin intake over 0.4
      U/Kg/day, Body mass index (BMI) between 25 and 30 kg/m2 . Moderate-intensity aerobic exercise
      was defined according to the classification standard of the ACSM, which refers to exercise
      where the HRR of subjects is 64-76%; the moderate-intensity target heart rate area was set in
      advance and controlled by heart rate monitor during the intervention, and the menarche was
      began from 3 to 5 years. The patients had no history of severe and frequent hypoglycemia in
      the last 6 months (< 60 mg/dl, more than twice a week).

      All participants attended a clinic for clinical assessments before and after treatment plane.

        1. Body Mass Index (BMI)

        2. Fitness score

        3. Target Heart Rate

        4. Fasting blood samples, post prandial and HbA1c: were taken for the following
           measurements: glucose.

        5. Estradiol blood test
    

Intervention name(s): aerobic exercise
Intervention type(s): Other
Intervention description(s): moderate intensity aerobic exercise using treadmill
Intervention model: Single Group Assignment
Intervention model description: prospective study
Masking: None (Open Label)
Primary purpose: Treatment
Bobath Approach for Trunk Control in Acute Stroke Patients
Condition: Stroke, Acute
MeSH terms: Stroke
Study type: Interventional

Summary: 
      In stroke patients, the impairment of the trunk affects many functions negatively. For this
      reason training of the trunk is necessary in the early period. Taking into account of
      literature, various approaches have been used to improve sitting balance and trunk control
      such as conventional physiotherapy for stroke patients . Bobath concept is another method
      used for stroke rehabilitation. When the studies about stroke rehabilitation are
      investigated, it is seen that most of the studies included only chronic patients and Bobath
      concept did not adequately take place in literature about trunk training. The aim of this
      study is to determinate effectiveness of the Bobath based trunk training on trunk control in
      acute stroke patients.
    

Detailed description: 
      In stroke patients, the impairment of the trunk affects many functions negatively. For this
      reason training of the trunk is necessary in the early period. Taking into account of
      literature, various approaches have been used to improve sitting balance and trunk control
      such as conventional physiotherapy for stroke patients . Bobath concept is another method
      used for stroke rehabilitation. Trunk control is an important issue in the Bobath approach
      since the acute period. It seems that the Bobath method, which includes both approaches to
      increase postural control and sitting, as well as applications to increase the sensation,
      seems to be an appropriate method to improve body control in stroke patients. When the
      studies about stroke rehabilitation are investigated, it is seen that most of the studies
      included only chronic patients and Bobath concept did not adequately take place in literature
      about trunk training in acute stroke. The aim of this study is to determinate effectiveness
      of the Bobath based trunk training on trunk control in acute stroke patients.
    

Intervention name(s): trunk training; physiotherapy
Intervention type(s): Other; Other
Intervention description(s): Bobath based trunk training; conventional physiotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Physiotherapy; Trunk control; Bobath concept; Stroke rehabilitation