bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Curcumin on Lung Inflammation
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Pneumonia; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Inflammation
Study type: Interventional

Summary: 
      Chronic obstructive pulmonary disease (COPD) and lung cancer are leading causes of death and
      health care use. Diffuse airways inflammation is seen in COPD and is thought to be the reason
      for deterioration of lung function in COPD. Currently there is no medication available that
      can modify or reduce this inflammation. Furthermore, from literature review it has been shown
      that chronic inflammation can result in cancerous changes.

      Curcumin is a food additive used for centuries. Several studies showed that curcumin suppress
      the different inflammatory pathways. Specially, the TNF-alpha and the NF kappa-b are down
      regulated by this substance. This study was designed to evaluate effect of combination of
      curcumin+Bioprine on sputum cytology in patients with COPD. This is double-blind randomized
      pilot study.
    


Intervention name(s): Curcumin+Bioprine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The intervention arm is Curcumin+Bioprine at escalating doses of 1 gram of Curcumin and 5 mg of Bioprine bid for one month, then 1.5 grams of Curcumin and 5 mg of bioprine bid for one month, and finally 2 grams of curcumin with 5 mg of bioprine bid for additional one month.
Intervention MeSH terms: Curcumin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: proven diagnosis; COPD; sputum
ELEKT-D: Electroconvulsive Therapy (ECT) vs. Ketamine in Patients With Treatment Resistant Depression (TRD)
Condition: Treatment Resistant Depression; Electroconvulsive Therapy; ECT; Ketamine; Psychiatric Disorder; Depression; Major Depressive Disorder; Major Depressive Episode; Unipolar Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant; Mental Disorders; Problem Behavior
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The goal of the study is to conduct a comparative randomized trial of electroconvulsive
      therapy (ECT) vs. ketamine for patients with treatment resistant depression (TRD) in a real
      world setting with patient reported outcomes as primary and secondary outcome measures.
    

Detailed description: 
      Patients with treatment resistant depression who meet all inclusion criteria and do not meet
      any exclusion criteria will be randomized to either electroconvulsive therapy (ECT) three
      times per week or ketamine infusion two times per week. Patients will answer questionnaires
      about their symptoms prior to treatments. The acute treatment phase of the study will last
      three to five weeks. Depending on response to treatment, some patients will be followed for
      an additional six months.
    

Intervention name(s): electroconvulsive therapy (ECT); Ketamine
Intervention type(s): Procedure; Drug
Intervention description(s): ECT is a procedure done under general anesthesia where small electric currents are passed through the brain, intentionally triggering a brief seizure. Patients who have not responded to antidepressant medications may be candidates for ECT. ECT is FDA approved for treatment resistant depression.; Ketamine is a medication that is used as a short acting anesthetic in pediatric and adult medicine. Subanesthetic (low) doses will be given to patients via infusion in order to assess whether it helps with depression symptoms in patients who have not responded to antidepressant therapy. Ketamine is not FDA approved for this indication and its effectiveness in treatment resistant depression has not been proven. Prior studies have indicated that subanesthetic doses of ketamine may be helpful for treatment resistant depression.
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: unblinded prospective randomized open-label
Masking: None (Open Label)
Primary purpose: Treatment
Insulin Resistance in Idiopathic Oligospermia and Azoospermia
Condition: Insulin Resistance; Oligospermia; Azoospermia
MeSH terms: Azoospermia; Oligospermia; Insulin Resistance
Study type: Interventional

Summary: 
      Insulin resistance in men can be the underlying major factor in reproductive abnormalities (
      chronic hypospermatogenesis ) as well as metabolic abnormalities similar to polycystic
      ovarian syndrome ( PCOS ) in women.
    

Detailed description: 
      During the past decade IR has been recognized as a major contributor to the pathogenesis of
      chronic anovulation, hyperandrogenism and metabolic abnormalities associated with PCOS .
      Theoretically IR in men may result in a similar reproductive abnormalities ( chronic
      hypospermatogenesis ) as well as other metabolic abnormalities similar to what happens in
      PCOS in women .
    

Intervention name(s): blood samples; Blood samples
Intervention type(s): Other; Other
Intervention description(s): blood samples to test for primary and secondary outcome measures; IR Cholesterol HDL LDL Fasting Glucose Triglycerides
Other intervention name(s): Unexplained oligospermia and azoospermia; Hypospermatogenesis
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: insulin resistance; unexplained azoospermia; unexplained oligospermia
Supine Percutaneous Nephrolithotomy
Condition: Renal Stone
MeSH terms: Kidney Calculi; Nephrolithiasis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      there is an increased incidence of renal stones, especially in the pediatric age group. the
      percutaneous approach in the pediatric age took a long time till it again accepted among
      surgeons worldwide. the prone position is the preferred approach to perform percutaneous
      nephrolithotomy in the pediatric age group. this study aims to compare supine versus prone
      position percutaneous nephrolithotomy in the pediatric age group.
    

Detailed description: 
      The incidence of renal stones in the pediatric age group increased from 18.4 to 57.0%
      per100,000 children in the period from 1999 to 2008. The acceptance of PCNL in pediatrics was
      slow at first due to concerns of the small kidney size compared to relatively large
      instruments percutaneous nephrolithotomy in pediatric patients was conventionally performed
      in the prone position for historical reasons, being more familiar to surgeons and it was
      considered safer to avoid colonic injury.

      Supine PCNL has several valuable advantages to pediatric patients in particular better
      irrigation shorter operative time with a comparable outcome with the prone position.

      our study aims to assess the efficacy and the safety of percutaneous nephrolithotomy in the
      supine position in comparison to the prone position in the pediatric age group.
    

Intervention name(s): percutaneous nephrolithotomy (supine position); percutaneous nephrolithotomy ( prone position)
Intervention type(s): Procedure; Procedure
Intervention description(s): percutaneous nephrolithotomy to be done in the supine position; percutaneous nephrolithotomy in the prone position
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: percutaneous nephrolithotomy to be performed in both supine and prone position
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of New Specifications (2.25mm) of FirehawkTM in the Treatment of Coronary Heart Disease ( Firehawk_2.25 )
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional

Summary: 
      The purpose of this study is to evalute the clinical safety and effectiveness of released
      specification (2.25mm) of FirehawkTM Sirolimus target-eluting coronary stent system.
    


Intervention name(s): FirehawkTM 2.25mm
Intervention type(s): Device
Intervention description(s): Implantation of the released specification (2.25mm) of FirehawkTM rapamycin target-eluting coronary stent systems
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Insulin Resistance on Branched Chain Amino Acid Metabolism.
Condition: Obesity; Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      It has been observed that subjects with obesity and insulin resistance have higher
      concentrations of branched chain amino acids in plasma or serum. However, this association
      has been established under fasting conditions, so they only give information about a
      metabolic state and do not reflect the dynamics and flexibility of the metabolism of these
      amino acids in the absence or presence of insulin resistance. The main aim of this study is
      to compare the catabolism of branched chain amino acids and their keto acids in subjects with
      and without insulin resistance, after the infusion of an amino acid solution with high
      concentration of the branched chain amino acids, leucine, valine, and isoleucine. The results
      of this project will allow the investigators to understand the dynamics of the branched chain
      amino acids and their derivatives, and its relationship with insulin resistance, which could
      eventually be used to design nutritional strategies to treat insulin resistance and thus,
      delay the development of type 2 diabetes.
    

Detailed description: 
      An 8% crystalline L-amino acid solution with high concentrations of branched chain amino
      acids, leucine, isoleucine, and valine, will be administered intravenously. The dose will be
      calculated considering the 25% of the estimated protein per day. For example, if the patient
      is 70 kg and the investigators consider 1g/kg/day, the amount of protein to be administered
      will be 17.5 grams (70 x 0.25 = 17.5 grams). This dose will be placed in a short peripheral
      intravenous catheter and administered at a rate of 1.5ml per minute, using an infusion pump.
      The patient will be monitored all the time by a physician. After the administration of the L-
      amino acid solution, the investigators will take blood samples at 0, 15, 30, 45, 60, 90 and
      120 minutes to determine the area under the curve for glucose, insulin, amino acids and
      branched chain keto acids.
    

Intervention name(s): Administration of an 8% crystalline L-amino acid solution with high concentrations of branched chain amino acids.
Intervention type(s): Other
Intervention description(s): Intravenous administration of 8% crystalline L-amino acids with high concentrations of branched chain amino acids.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The groups will receive the treatment simultaneously
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Dual-wave Insulin Bolus on Postprandial Glycaemia
Condition: Type1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      A study was conducted in adolescents with type 1 diabetes (T1D) examining the effect of
      different bolus types on 6-h postprandial glucose levels after the consumption of 3 standard
      meals with varying composition. Participants were asked to consume 10 different combinations
      of meal and bolus type.
    

Detailed description: 
      The nutritional recommendations of children and adolescents with T1D should be similar to
      those of healthy people in order to achieve the desirable growth. Not only the carbohydrates'
      intake is underlined according to special guidelines by Canadian diabetes association,
      American diabetes association and International Society for Paediatric and Adolescent
      Diabetes but also proteins and fats are suggested to be taken into consideration in the
      management of T1D. In order to reach the desirable euglycemic control, children and
      adolescents can use multiple daily injections (MDI) or continuous subcutaneous insulin
      infusion (CSII). By using the CSII the insulin can be administrated in three different
      patterns; as a normal bolus, as a dual wave bolus and as a square wave bolus. Dual wave
      insulin bolus (D/WB) is suggested as the most suitable option based on the effects that is
      having after meals with different content of carbohydrates, fats and proteins. The aim of
      this study was to evaluate the impact of different types of D/WB on PPG after 3 given meals,
      in adolescents with T1D on CSII. In order to achieve that, 3 different meals were designed
      and combined with alternative types of boluses, D/WB and square wave insulin bolus (S/WB).
    

Intervention name(s): insulin
Intervention type(s): Drug
Intervention description(s): All participants used the rapid-acting insulin analogue aspart (NovoRapid®, Novonordisk A/S, Bagsvaerd, Denmark) and total insulin dose administered to each one for each test meal was known in advance, according to the insulin to carbohydrate ratio that had been calculated during the 2-week pre-study period.
Other intervention name(s): NovoRapid
Intervention MeSH terms: Insulin; Insulin Aspart
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 diabetes; Dual-wave bolus; Postprandial euglycaemia
Accuscreen Equipment Evaluation For Newborn Hearing Screening
Condition: Hearing Loss
MeSH terms: Hearing Loss; Deafness
Study type: Observational

Summary: 
      An evaluation and comparison of results between the 'Accuscreen New' currently in use and an
      'Accuscreen New' with different settings to see if the new settings reduce unnecessary
      referrals for babies from newborn hearing screening.

      Babies will be tested with the standard and modified equipment. Referrals for diagnostic
      testing will be based on the standard equipment. A comparison in referrals between the
      standard and modified equipment will be made.
    

Detailed description: 
      All newborn babies undergo hearing screening, usually within the first few days of life and
      some are tested with the automated auditory brainstem response test (AABR). This involves
      recording activity from the hearing nerve and parts of the brainstem from three small sensors
      placed on the baby's head and neck when a series of clicking sounds are played in to the ear.

      In March 2015 we started using an 'Accuscreen New' to record the AABR, which is approved by
      the Newborn Hearing Screening Programme (NHSP) and used widely across the UK. However, since
      introducing the new equipment the 'screen refer' rate increased significantly in very young
      babies (less than 48 hours old) and diagnostic testing showed they had satisfactory hearing.
      The impact of the increased referral rate caused increased delays on diagnostic testing and
      also lead to unnecessarily increased parental anxiety in relation to the hearing of their new
      born baby.

      The equipment suppliers (GN Otometrics) and the NHSP Programme centre have agreed to an
      evaluation and comparison of results between the 'Accuscreen New' currently in use and an
      'Accuscreen New' with different settings which we believe will reduce unnecessary referrals
      of so many young babies to Audiology (the modified equipment will test for up to 10 minutes
      to see if a response is present, instead of stopping after one or two minutes).

      Babies will be tested with the standard and modified equipment. Referrals for diagnostic
      testing will be based on the standard equipment. A comparison in referrals between the
      standard and modified equipment will be made.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Babies undergoing newborn hearing screening
      
Keywords: Newborn hearing screening; Hearing loss; Hearing screening equipment
MiVideo - Video Visit Summary for Cancer Patients
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Cancer patients about to begin chemotherapy receive large amounts of information regarding
      their prognosis, how chemotherapy improves their prognosis, and the usual side effects of the
      chemotherapy during their first visit to the oncologist. Prior studies have documented that
      less than half of this information is retained after the visit, making it difficult for
      patients to participate in their care and difficult for them to enlist the help of their
      social support. The MiVideo project allows the physician to create a custom 5-minute summary
      video summary of a pre-chemotherapy clinic visit and upload it to a secure web site. The
      video will emphasize the major points of the forty-five minute office discussion, allowing
      patients to review the physicians' recommendations and share the information and
      recommendations with others. By providing the patient with this re-cap of their visit, the
      investigators hope to engage them more actively in their cancer treatment. Making the
      information available to friends and family can also help a patient receive both intellectual
      and emotional support during the course of treatment. The primary endpoint of this study is
      improvement of patient care, not research activity.

      Primary Hypothesis: Creating a 5-minute video summarizing information about diagnosis, stage,
      chemotherapy treatment plan, and anticipated side effects for patients starting chemotherapy
      for colon cancer will not significantly lengthen the pre-chemotherapy clinic visit as
      compared to visits that do not include video production.
    


Intervention name(s): Pre-chemotherapy visit summary Video
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Psychophysical Characterization and Brain Correlates of Dentine Hypersensitivity
Condition: Dentine Hypersensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Observational

Summary: 
      Up to date, devices capable of delivering controlled, calibrated, non-contact cold air
      stimuli in a MR environment are unavailable for quantitative sensory testing. This project
      therefore aimed at designing and constructing a novel MR-compatible, computer-controlled cold
      air stimulation device that produces air puffs in a broad flow and cold temperature range. By
      means of this device, detailed psychophysically testing and subsequent brain scanning of
      dentine hypersensitivity (DH) subjects will be possible to gain new insights about DH
      mechanisms.
    


Intervention name(s): air puffs
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Dentine hypersensitivity (DH) is characterized by a short, sharp pain arising from exposed
        dentin.
Avascular Bone Necrosis in Sickle Cell Disease: a Pediatric Study.
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Observational [Patient Registry]

Summary: 
      Avascular necrosis (AVN) is a serious complication of sickle cell disease, especially in
      pediatric patients where the prevalence is between 3% and 8% and are more frequent in
      patients with multiple vaso-occlusive crisis (VOC). The prevalence of AVN is usually made by
      a study of the hip through radiography, whereas other possible sites of ischemic infarcts are
      evaluated only in case of specific symptoms. In addition, bone infarcts may be the trigger
      for additional VOC.

      In this study, we want to investigate the presence of possible bone lesions even in
      asymptomatic or paucisymptomatic children.

      This is a prospective interventional and monocentric study whose objective is to describe the
      prevalence of osteonecrosis in children with sickle cell disease in Italy
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Sickle cell pediatric patients followed in consultation in Microcitemie Centre within the
        framework of their sickle cell disease at San Luigi Gonzaga Hospital, Orbassano (Turin),
        Italy
      
Keywords: Avascular necrosis
Gross Myofascial Release in Cervical Radiculopathy Pat
Condition: Cervical Radiculopathy
MeSH terms: Radiculopathy
Study type: Interventional

Summary: 
      To investigate the Effect of gross Myofascial Release on pain and function in cervical
      radiculopathy patients. BACKGROUND: cervical radiculopathy is considered serious problems
      causing neck pain & radiating pain which affect physical inactivity and function of a
      patient, thus gross Myofascial Release is a form of manual therapy technique that has a
      profound effect upon the musculoskeletal system.

      HYPOTHESES:

      This study hypothesized that:

      gross Myofascial Release on pain and function in cervical radiculopathy patients RESEARCH
      QUESTION: Is there an effect of gross Myofascial Release on pain and function in cervical
      radiculopathy patients?
    

Detailed description: 
      Forty patients with cervical radiculopathy will participate in this study. The patients will
      randomly be divided into two equal groups; the control group which received the conventional
      selected exercise program and the study group received the same exercise training program in
      addition to gross Myofascial Release, three times per week for four weeks. The evaluation
      methods are visual analogue scale (VAS), Electro-goniometer, Quick DASH scale, and Neck
      disability index
    

Intervention name(s): gross Myofascial Release; conventional selected exercise program; Transcutaneous electrical nerve stimulation (TENS)
Intervention type(s): Other; Other; Device
Intervention description(s): Gross Myofascial Release : is amanual technique in form of Stretch of the Posterior Cervical Musculature and Gross stretch of gross Myofascial Release upper quarter: Arm Pull for duration of 10-15 min per session each stretch position was healed for 90sec; stretching exercises for cervical muscles and pectoralis major and source of heat in form of hot packs for 15 minutes; Transcutaneous electrical nerve stimulation (TENS) is a method of pain relief involving the use of electrical current, the electrode placement on the course of pain for 15 minutes
Other intervention name(s): TENS
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: the control group which received the conventional selected exercise program and the study group received the same exercise training program in addition to gross Myofascial Release
Masking: None (Open Label)
Primary purpose: Treatment