bioihbjkbjnl/mcl2 huggingface dataset:
Advanced MRI Measures of Repair in Alemtuzumab Treated Patients
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      There are two parts to this investigator sponsored trial (IST):

        1. To perform advanced serial MRI studies on patients initiating alemtuzumab therapy.

        2. To provide serum samples for the University of Southern California (USC) ICAM125
           lymphocyte recovery study.
    

Detailed description: 
      Multiple Sclerosis (MS) is an inflammatory demyelinating disease of the Central Nervous
      System (CNS). There are many forms of MS; although the majority are Relapsing Remitting
      (RRMS) representing approximately 80% of the cases. The disease appears to be more
      inflammatory in RRMS as manifested by an increase in Gadolinium (Gd) enhancement on MRI and
      an increase in inflammatory bio-assay markers.

      Alemtuzumab; a humanized monoclonal antibody that targets the CD52 molecule present on T and
      B lymphocytes, natural killer (NK) cells, and monocytes and macrophages; effects rapid and
      sustained lymphocyte depletion and is approved for the treatment of B-cell chronic
      lymphocytic leukemia in many countries under the names CAMPATH or MabCAMPATH.

      There are two parts to this Investigator Sponsored Trial (IST):

        1. To perform advanced serial MRI studies on patients initiating alemtuzumab therapy.

        2. To provide serum samples for the University of Southern California (USC) ICAM125
           lymphocyte recovery study.
    

Intervention name(s): MabCampath-1h
Intervention type(s): Drug
Intervention description(s): Drug:10 mg/mL alemtuzumab intravenous infusion. Form: Sterile, clear, colorless solution. Dosage: 2 cycles. Month 0 dosed over 5 consecutive days; month 12 dosed over 3 consecutive days.
Other intervention name(s): Alemtuzumab
Intervention MeSH terms: Alemtuzumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; MS; Relapsing Remitting Multiple Sclerosis; RRMS; Alemtuzumab; Demyelination; Remyelination; Tolerogenic; T cells; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases
Effect of Irbesartan on Endothelial Function of the Retinal Vasculature in Patients With Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The retinal vasculature is morphologically and functionally related to the cerebral vessels
      due to its common origin from the internal carotid artery. A recent study demonstrated that
      endothelium-dependent vasodilation of the retinal vasculature is impaired in patients with
      essential hypertension, which is a strong risk factor for stroke. Furthermore, AT1-receptor
      blockade was demonstrated to improve retinal endothelium-dependent vasodilation in these
      hypertensive patients. Hypercholesterolemia is also a risk factor for ischemic stroke and
      impairment of endothelial function has been observed in various vascular beds in
      hypercholesterolemic patients, including the coronary and the forearm vasculature. Whether
      endothelial function of the retinal vasculature is impaired in patients with
      hypercholesterolemia has not yet been investigated. In patients with stroke, AT1-receptor
      blockade and angiotensin-converting enzyme inhibition have beneficial effects on clinical
      outcome. Alterations of endothelial function of the cerebral vasculature might be one
      pathogenetic factor for the beneficial clinical outcome. To further address this issue, the
      present study was designed to test the hypothesis that endothelium-dependent vasodilation of
      the retinal vasculature is impaired in hypercholesterolemic patients and that endothelial
      function can be improved by AT1-receptor blockade.
    

Detailed description: 
      see above
    

Intervention name(s): Irbesartan
Intervention type(s): Drug
Intervention MeSH terms: Irbesartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Using Bupivacaine Locally in the Mastectomy Drains to Control Postoperative Pain
Condition: Pain, Postoperative; Breast Cancer
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      in this study we are investigating the role of instillation of Bupivacaine through surgical
      drains at the end of mastectomy surgeries in controlling post operative pain and decreasing
      their pain killers requirement in the early postoperative period
    

Detailed description: 
      patients were enrolled into 2 groups. in one group the wound was installed by 40ml of 0.25%
      bupivacaine through axillary and chest wall drains (20ml in each drain). Then, the drains
      were clamped for 20 minutes.

      in the other group the wound was installed by 40ml of 0.9% normal saline through axillary and
      chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes.
      (placebo group) patients and health care providers were blinded as regard the study group
      patients enrolled in. Visual Analog Pain Scale which is a score for detection of how much the
      patient is annoyed from the pain- was assessed two and four hours post-operative then every
      four hours thereafter.
    

Intervention name(s): 40ml of 0.25% bupivacaine; 40ml of 0.9% normal saline
Intervention type(s): Drug; Drug
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: bupivacaine; Post-mastectomy acute pain; Wound instillation
Stent-related Symptoms Comparison: Polaris Loop vs Vortek Double-J Stents
Condition: Symptoms and Signs; Pain; Renal Calculi
MeSH terms: Kidney Calculi; Nephrolithiasis; Calculi
Study type: Interventional

Summary: 
      Prospective randomized controlled single-blind parallel-group trial in order to compare
      symptoms related to loop-tail (Polaris Loop) stents versus conventional double J (Vortek)
      stents after uncomplicated flexible URS.
    

Detailed description: 
      Patients undergoing RIRS for a single renal stone < 2 cm are asked to participate in a
      prospective randomized controlled single-blind parallel-group study. Ureteral stent is always
      placed after flexible URS. Patients are prospectively randomized into two groups with a 1:1
      allocation: group LT receive loop-tail stents (Polaris ™ Loop - Boston Scientific, Natick,
      USA), while group DJ receive conventional double J stents (Vortek ® - Coloplast, Humlebaek,
      DK). Stent removal is planned 4 weeks after the procedure.

      Participants are asked to fill in the Italian validated version of the Ureteral Stent
      Symptoms Questionnaire (USSQ) 2 days and 4 weeks after surgery. The USSQ is further submitted
      4 weeks after stent removal (8 weeks after surgery) and these results are used as baseline
      evaluation, on the assumption that SRS persist for a few days after removal.
    

Intervention name(s): USSQ questionnaire administration after RIRS.
Intervention type(s): Other
Intervention description(s): USSQ symptoms questionnaire administration after RIRS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Symptoms and Signs; Pain; Renal Calculi; Ureteral Stent; Ureteroscopy
SMART Protocol vs Antagonist Protocol in IVF
Condition: Diminished Ovarian Reserve
Study type: Observational

Summary: 
      This retrospective study aims to assess the effect of adding letrozole in patients who have
      previously undergone an IVF cycle with either an antagonist or short protocol, with patients
      who have undergone a second cycle of IVF with an antagonist or short protocol without the
      addition of letrozole.
    

Detailed description: 
      A limited number of studies suggest that the addition of letrozole to gonadotropins for IVF
      is associated with an increase in oocyte count, blastocyst count and implantation rate. These
      differences are presumed to be caused by an increase in intra-ovarian androgens associated
      with the addition of letrozole.

      In patients with reduced ovarian reserve or reduced oocyte quality in the previous cycle,
      supplementation with of letrozole has the potential to increase oocyte count or oocyte
      quality, thereby resulting in more transferable blastocysts. The antagonist stimulation
      protocol with the addition of letrozole is commonly referred to as the SMART protocol
      (Stimulation with Minimal Adverse effects, Retrieval and Transfer
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This retrospective cohort study will analyze IVF cycles in antagonist and SMART stimulation
        protocols during the period from 2010 to 2020.
      
Keywords: IVF; Fertility issues
Oral Sildenafil in Persistent Pulmonary Hypertension Secondary to Meconium Aspiration Syndrome in Newborns
Condition: Meconium Aspiration Syndrome; Persistent Pulmonary Hypertension of Newborn
MeSH terms: Hypertension, Pulmonary; Meconium Aspiration Syndrome; Persistent Fetal Circulation Syndrome; Hypertension; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to to study the role of oral Sildenafil in Persistent Pulmonary
      Hypertension of Newborn (PPHN) secondary to Meconium Aspiration Syndrome (MAS) in newborns
      and to study risk factors of MAS developing into PPHN.
    

Detailed description: 
      Design: Randomized control trial Setting: Neonatal intensive care unit in a tertiary care
      hospital Patients: Patients diagnosed with MAS with PPHN according to clinical criteria. 97
      patients with MAS were enrolled in the study over a period of 8 months, out of which 40
      patients with PPHN were randomized into two groups.

      Intervention: Group A received Sildenafil through a feeding tube (1 mg/kg/dose q6h) for 8
      doses. Group B received a placebo. Outcome measures: Improvement in oxygen saturation (SpO2),
      oxygenation index (OI), duration of hospitalization and mechanical ventilation and mortality.
    

Intervention name(s): Oral Sildenafil; Placebo (distilled water)
Intervention type(s): Drug; Drug
Intervention description(s): Patients were randomized into two groups. Placebo was prepared with distilled water. In group A, newborns received oral Sildenafil solution through feeding tube which was prepared by crushing a 50 mg tablet of sildenafil in distilled water to make a concentration of 5 mg/ml. In group B, newborns received placebo. The protocol for dosing was (1) first dose of 1 mg/kg/dose within 30 minutes admission or within 12 hours of delivery (whichever earlier), (2) Dosing every six hours for a maximum of 8 doses, (3) Dose was doubled if the oxygenation index (OI) or SpO2 did not improve (If OI continued to be <10% of previous value and SpO2 was not increasing >5 of previous value) and blood pressure remained stable; Distill water oral
Other intervention name(s): Viagra; Integra; Water
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: MAS; PPHN; Sildenafil; Newborn; Pulmonary Hypertension
Trans Radial Versus Transfemoral Route for Coronary Angiography
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      The purpose of this study was to assess and compare the feasibility, success and safety of
      Transradial approach (TRA) verses Transfemoral approach (TFA) for diagnostic and therapeutic
      coronary angiography and coronary interventions, in terms of procedural time, access time,
      fluoroscopy time, procedural failure, , length of hospital stay in terms of days in hospital,
      Complications in terms of thrombophlebitis, hematoma, ecchymosis, infections thrombosis of
      vessel, MACE, Stroke and others.
    

Detailed description: 
      Background: PCI has been done traditionally through transfemoral route. But now transradial
      and transbrachial routes are also coming up in practice. We compared transradial versus
      transfemoral routes for ease of operability, time for procedure, complications, and failure
      rates through a prospective study. Methods: 400 Patients admitted in department of cardiology
      for percutaneous interventions were enrolled in the study. 200 patients were assigned to each
      group randomly. A single team did all the procedures. Pre procedure, intra procedure and post
      procedure data of all the patients was collected, tabulated and analysed properly.

      The variables studied include Access time ,Fluoroscopy time and overall procedure time, post
      procedure complications( ecchymosis ,Thrombophelibites, Hematoma, procedure access bleed),
      Failure rates,post procedure myocardial infarction, stroke, acute renal failure and
      infections.
    

Intervention name(s): transradial; Transfemoral
Intervention type(s): Procedure; Procedure
Intervention description(s): transradial route for coronary angiography and PCI; transfemoral route for coronary angiography and PCI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of "On Line" Telematic Spirometry
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The investigators aim to demonstrate that spirometry performed "on line" with a technician in
      a remote place from the patient has the same efficacy as the one performed personally. As a
      previous study the investigators analyzed the inter-observer agreement between two pulmonary
      function technicians from both centers taking part in the study: San Pedro de Alcántara
      Hospital (Cáceres) and Carlos III hospital (Madrid). The main study will be broad (226
      patients derivates from primary care to pneumology consultation), prospective, aleatorized,
      crossed, blind and controlled. The patients will be aleatorized in two groups: 1) personal
      spirometry: performed in a conventional way; 2) telematic spirometry: performed remotely "on
      line". The same pulmonary function technician, who will carry out the spirometries
      personally, will be located in a nearly room. The technician will control the computer office
      and the spirometer software in the patients's room with another computer. By means of
      teleconference, the technician will indicate the patient to start the maneuver. After 20
      minutes from the end of the first spirometry, the patients will complete the protocol of the
      following group. The mean values of FVC, FEV1 and FEV1/FVC, the mean time of spirometry
      performance, the mean number of spirometric maneuvers performed, are compared between both
      groups by t proof for paired data. The comparison of the percentage of proofs with non
      acceptability or reproducibility criteria will be made by X2 test. The analysis will be made
      blindly. The inter-observer and intra-observer agreement will be evaluated by analysis of
      intraclass correlation for FVC and FEV1 values.
    


Intervention name(s): spirometry
Intervention type(s): Device
Intervention description(s): Conventional and telematic spirometry
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: COPD; spirometry; Telematic spirometry
Calcium + Vitamin D Supplementation for Low Bone Mass in Adolescent Idiopathic Scoliosis (AIS)
Condition: Scoliosis
MeSH terms: Scoliosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether Calcium and Vit D supplementation is
      effective for improving low bone mass in Girls with Adolescent Idiopathic Scoliosis (AIS).
    

Detailed description: 
      Adolescent Idiopathic Scoliosis (AIS) is a prevalent condition mainly affecting females with
      disease onset at early puberty. It can lead to serious health problems and is associated with
      low bone mass which can persist with growth. Osteopenia is found to be an important
      prognostic factor for curve progression in AIS. Nutritional studies indicated AIS subjects
      had low dietary calcium intake. Evidences suggested that Vit D insufficiency could be present
      in AIS. Calcium and vitamin D supplementation can therefore be a viable treatment option for
      low bone mass in AIS subjects. The primary objective of this prospective randomized
      double-blinded placebo-controlled trial is to find out whether calcium and vitamin D
      supplementation can improve bone mineral density (BMD) in osteopenic AIS subjects. The
      secondary objective of this study is to evaluate whether the supplementation is effective in
      controlling curve progression in AIS.
    

Intervention name(s): Calcium 600mg plus Vit D 400 IU; Calcium 600mg plus Vit D 800 IU; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Daily supplementation with 600mg Calcium plus 400IU Vitamin D3; Daily supplementation with 600mg Calcium plus 800IU Vitamin D3; placebo tablets
Intervention MeSH terms: Calcium, Dietary; Vitamin D; Calcium Carbonate; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adolescent Idiopathic Scoliosis; AIS; low bone mass; osteopenia; bone health; bone density
Effect of Processed Blueberry on Blood Glucose and Antioxidant Status in Human Adults
Condition: Blood Glucose
Study type: Interventional

Summary: 
      Canada's Food Guide (2007) recommended 7-10 servings of fruits and vegetables per day for a
      normal adult population. Although fruit juice (125 ml) is considered as one serving of
      fruits, the consumption of some fruit juices may be limited due to their high amount of
      sugar. The consumption of sugary drinks can lead to a rapid rise in postprandial glycaemia.
      Wild blueberries, due to their high level of anthocyanins, may provide multiple health
      benefits including improved blood glucose control, however, the consumption of fresh berries
      is limited by their short seasonal availability. Hydro-Thermodynamic (HTD) processing of
      blueberries allows the processing of whole berries including their skin and seeds into a
      beverage with the amount of anthocyanins comparable with fresh berries. The objective of the
      study is to investigate the effect of HTD-processed blueberries on postprandial glycaemia and
      antioxidant activity.
    


Intervention name(s): Food-1; Food-2
Intervention type(s): Other; Other
Intervention description(s): HTD-blueberry beverage with white bread.; Sweetened water with white bread as a control.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Blueberry; Blood Glucose; Antioxidants; Hydro-Thermodynamic Processing; Beverages
Impact of the Introduction of a Gastro-intestinal Panel by Polymerase Chain Reaction (PCR).
Condition: Gastroenteritis
MeSH terms: Gastroenteritis
Study type: Observational

Summary: 
      Evaluation of the impact of the introduction of multiplex PCR panels on the clinical
      management of patients with gastroenteritis at the University Hospital of Lausanne,
      Switzerland.
    

Detailed description: 
      Gastrointestinal multiplex PCR panels have been introduced in clinical practice several years
      ago, but the impact on the management of patients is yet unknown. The investigators are
      interested to evaluate if the multiplex PCR panels introduced at the University Hospital of
      Lausanne in July 2017 modified the usual medical care and in particular the prescription of
      anti-infectious treatments. The high sensitivity of the multiplex PCR panels should allow a
      more precise diagnosis of the etiology of the gastrointestinal symptoms of the patients than
      the traditional methods of stool culture and microscopy. The investigators expect therefore
      to observe a modification of the proportion of patients receiving anti-infectious treatment,
      but it is uncertain if it will lead to an increase or a decrease in the use of antibiotics.
      On one hand antibiotics could be prescribed more often due to a greater and faster detection
      of enteropathogens. On the other hand antibiotics could be prescribed less often due to more
      precise diagnosis, showing that viruses and certain bacteria do not require antibiotic
      treatment.
    

Intervention name(s): Gastro-intestinal panel by PCR
Intervention type(s): Diagnostic Test
Intervention description(s): The study will evaluate the change in medical management with the replacement of traditional stool investigations (microscopy and culture) by the new gastrointestinal multiplex PCR panels
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients consulting the emergency department of the University Hospital of Lausanne for
        gastro-intestinal symptoms suggestive of an infectious origin
      
Keywords: Gastroenteritis, panel by PCR, antibiotic use
Budesonide Capsules vs. Mesalazine Granules vs. Placebo in Collagenous Colitis
Condition: Collagenous Colitis
MeSH terms: Colitis; Colitis, Collagenous
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether budesonide or mesalazine is more active in
      the treatment of collagenous colitis.
    

Detailed description: 
      This study will check the reproducibility of the results reported in trials with budesonide
      in patients with collagenous colitis. Efficacy of mesalazine was never tested in collagenous
      colitis by placebo-controlled trials. This trial will check the superiority of mesalazine
      over placebo using the common clinical symptom of collagenous colitis, which is chronic or
      recurrent non-bloody, watery diarrhea.
    

Intervention name(s): Budesonide; Mesalazine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 9 mg per day; 3 g per day; 0 g per day
Intervention MeSH terms: Budesonide; Mesalamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment