bioihbjkbjnl/mcl2 huggingface dataset:
Monitoring of Symptoms and Cognitive Function Using Telehealth
Condition: End Stage Liver Disease
MeSH terms: Liver Diseases; End Stage Liver Disease
Study type: Interventional

Summary: 
      End-Stage Liver Disease (ESLD) is one of the ten leading causes of death in US. It is marked
      by episodic acute exacerbations of the underlying liver disease which often leads to severe
      symptoms, poor quality of life, mental deterioration and repeated hospitalizations.

      The overall purpose of this project is to introduce a telehealth based intervention
      (involving remote monitoring of symptoms and cognitive function initiated at the time of
      discharge of ESLD patients. This will support enhanced clinical care and improve
      self-management in ESLD population. In addition, it will reduce healthcare utilization,
      improve medication adherence and overall health outcomes
    

Detailed description: 
      This is a single arm study to assess the effectiveness of an experimental telehealth
      intervention within the treatment of ESLD, and compare it with a historic cohort. All
      inpatients with advanced liver disease and at least 1 complication will be eligible to
      participate. the study group receives the Telehealth intervention and will be given an ipad
      preloaded with the instruments used for symptom monitoring and cognitive function assessment
      during the hospital admission.
    

Intervention name(s): Telehealth
Intervention type(s): Other
Intervention description(s): Patients will be given an ipad with preloaded app (secured questions assessing their symptoms and cognitive function in a systematic timely way). The responses will be delivered to the care providers instantly, which will trigger an algorithmic clinical approach.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Telehealth; Quality of Life
Efficacy and Safety of Different Doses of BIRB 796 BS in Patients With Active Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective was to determine the effects of BIRB 796 BS on CRP and clinical parameters in
      Rheumatoid Arthritis as measures of efficacy, and on population pharmacokinetics and safety
      parameters
    


Intervention name(s): BIBR 796 BS; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Changes in Hematological Parameters With Glycemia Control in Type 2 Diabetes
Condition: Poorly Controlled Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      There is a systemic low-grade chronic inflammation in diabetes, and research suggests that
      this inflammation plays a vital role in the development of diabetic complications.
      Macrovascular complications, which are associated with atherosclerosis, are recognized as a
      chronic inflammatory disease. In this study, the aim was to evaluate the potential alteration
      in hematologic inflammatory markers among patients with poorly controlled type 2 diabetes
      subsequent to the enhancement of diabetes management.
    

Detailed description: 
      Patients who were referred to the Diabetes Outpatient Clinics and had HbA1c levels equal to
      or greater than 10% were enrolled in this study. Detailed medical histories, comorbidities
      and medication usage (including both regular and new prescriptions), adherence to dietary
      recommendations, and occurence of recent infections were collected. Additionally, the
      patients' biochemical and hematological data were collected. After a three-month period,
      follow-up interviews with the same patients were conducted to inquire about any changes in
      medication usage, experienced illnesses, and hospital admissions. Based on the changes in
      HbA1c levels during this three-month period, the patients were divided into three equal
      groups. The baseline and third-month leukocyte counts, neutrophil counts, lymphocyte counts,
      and platelet counts for these groups were recorded. Furthermore, the neutrophil/lymphocyte
      ratio, lymphocyte/monocyte ratio, platelet/lymphocyte ratio, monocytes/HDL-cholesterol ratio,
      and platelets/HDL ratio for each group were analyzed.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with poorly controlled type 2 diabetes, defined by an HbA1c level of >=10%, who
        attended diabetes outpatient clinics between January 2022 and January 2023.
      
Keywords: type 2 diabetes; glycemic control; neutrophils; neutrophil/lymphocyte ratio; lymphocyte/monocyte ratio; platelet/lymphocyte ratio; monocytes/HDL-cholesterol ratio; platelets/HDL ratio
A Phase 1 Dose Escalation Study to Examine the Safety of the P2-VP8 Rotavirus Vaccine
Condition: Rotavirus Infection
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate 3 doses of a new vaccine for rotavirus infection in healthy adult
      volunteers to determine if it is safe and if the immune systems of healthy adults respond to
      this vaccine.
    

Detailed description: 
      The trial will be a double-blinded, randomized, placebo-controlled dose-escalation study in
      which three dose-levels of vaccine will be tested in adults. Cohorts of 16 individuals (12
      vaccine recipients and 4 placebo recipients) per dose level will receive three intramuscular
      injections four weeks apart. The three dose levels of vaccine to test will be 10 microgram
      (μg), 30 μg and 60 μg.
    

Intervention name(s): P2-VP8 subunit rotavirus vaccine; placebo
Intervention type(s): Biological; Other
Intervention description(s): P2-VP8 subunit rotavirus vaccine was made by inserting a codon optimized synthetic gene for the VP8 region of rotavirus VP4 fused to the P2 T-cell epitope of tetanus toxin into the Pj411 proprietary cloning vector developed by DNA 2.0, Menlo Park, CA. The vector carries a kanamycin resistance gene as a selection marker. The vector was transfected into the BL21 strain of E. coli. The fusion protein was purified from Isopropyl β-D-1-thiogalactopyranoside (IPTG)-induced and physically lysed cultures using standard column chromatographic techniques employing Q-Sepharose and Butyl 650 as resins in addition to ultrafiltration and diafiltration.; Sodium Chloride 0.9%, USP for Injection was used to dilute the active P2-VP8 vaccine to final dosing concentration and was used for the Placebo for the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: rotavirus; vaccine
Efficacy and Safety of Growth Hormone Treatment in Juvenile Idiopathic Arthritis
Condition: Juvenile Idiopathic Arthritis; Still Disease, Juvenile-Onset
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 3

Summary: 
      Growth retardation is well known in patients with severe forms of juvenile idiopathic
      arthritis. Especially those who were under additional treatment with glucocorticoids for high
      disease activity. The hypothesis is, that treatment with growth hormone can, at leat in part,
      overcome growth hormone resistance state and increase final height. In a controlled study we
      follow patients with juvenile idiopathic arthritis with and without growth hormone treatment
      until final height. Additionally, we are interested in bone density development in those
      treated with growth hormone.
    

Detailed description: 
      Growth retardation is well known in patients with severe forms of juvenile idiopathic
      arthritis. Especially those who were under additional treatment with glucocorticoids for high
      disease activity. This is the case in patients with a polyarticular and a systemic form of
      juvenile idiopathic arthritis. The permanent consequence is short stature at final height. Up
      to 30% of these patients will have a final height below the 3rd percentile, even after
      discontinuation of glucocorticoid treatment. The hypothesis is, that treatment with growth
      hormone can, at leat in part, overcome growth hormone resistance state and increase final
      height. In a controlled study we follow patients with juvenile idiopathic arthritis with and
      without growth hormone treatment until final height. From safety aspects we were interested
      in the effect of growth hormone on the disease activity. Additionally, we are interested in
      bone density development in those treated with growth hormone up to final height.
    

Intervention name(s): Genotropin
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy Study of Vortioxetine on Cognitive Dysfunction in Adult Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 3

Summary: 
      Major Depressive Disorder (MDD) is a severe and common psychiatric disorder. Although MDD
      primarily involves mood disturbances, patients also usually present alterations in cognitive
      function (attention, memory, executive functioning and psychomotor speed). Even though
      antidepressants are suggested in the literature to potentially improve cognitive dysfunction
      in patients with MDD to some degree, there is a lack of adequate and well-controlled studies
      to investigate this effect. This study will evaluate the efficacy, safety and tolerability of
      a new antidepressant Vortioxetine versus placebo on cognitive dysfunction in adult patients
      with MDD.
    


Intervention name(s): Placebo; Vortioxetine (Lu AA21004); Vortioxetine (Lu AA21004)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): capsules; daily; orally; encapsulated tablets; daily; orally; encapsulated tablets; daily; orally
Other intervention name(s): Brintellix; Brintellix
Intervention MeSH terms: Vortioxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: MDD; Cognitive dysfunction
Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections
Condition: Abscess; Wound Infection; Surgical Site Infection; Cellulitis
MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection; Wound Infection; Cellulitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary object is to compare the early clinical efficacy (after 48-72 hours of therapy)
      of dalbavancin to the comparator regimen (vancomycin with the option to switch to oral
      linezolid) for the treatment of patients with a suspected or proven gram-positive bacterial
      skin or skin structure infection.
    


Intervention name(s): Dalbavancin; Vancomycin / Linezolid
Intervention type(s): Drug; Drug
Intervention description(s): IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8; IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
Intervention MeSH terms: Vancomycin; Linezolid; Dalbavancin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Treatment of Fever Due to Malaria With Ibuprofen
Condition: Fever
MeSH terms: Malaria; Fever
Study type: Interventional
Phase: Phase 4

Summary: 
      Drugs to treat fever are widely used in children with fever. But there is a controversy about
      the benefit of reducing fever in children with malaria. Ibuprofen is often used to treat
      malarial fever. This study evaluates the capacity of ibuprofen to reduce fever in malaria.
      The effect of ibuprofen on fever compared to only mechanical measures is investigated in
      children with malaria.
    

Detailed description: 
      Fever is the most apparent clinical manifestation of Plasmodium falciparum infection during
      the acute phase. The role of fever in defence against malaria or in other infectious diseases
      remains unclear. However, it has been shown that febrile temperatures inhibit the growth of
      P. falciparum in vitro.

      Antipyretic drugs are commonly and widely used to treat malarial fever in endemic areas.
      There is however a controversy about the benefit of reducing fever in children with malaria.
      Data from Gabon have revealed that neither paracetamol, nor naproxen or metamizol -
      antipyretics often used in this area - had an effect on fever clearance time. Worryingly,
      paracetamol increased parasite-clearance times (i.e. inhibited clearance of parasites) and
      decreased significantly the production of oxygen radicals and tumour necrosis factor (TNF),
      mechanisms of the innate immune response, pivotal to combat infections.

      Another antipyretic drug often used to treat malarial fever in endemic areas is ibuprofen.
      However, the rationale of its use and its capacity of reducing fever due to P. falciparum
      infections has never been proven in this area.

      Comparison: The effect of ibuprofen plus mechanical fever "treatment" (continuous fanning,
      tepid sponging, and cooling blankets) is compared to mechanical treatment alone to treat
      fever in children with malaria.
    

Intervention name(s): Ibuprofen
Intervention type(s): Drug
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Malaria; Fever; Ibuprofen; Gabon
Intravesical Glycosaminoglycan Instillation and Urinary Tract Infection in Acute Spinal Cord Injury
Condition: Spinal Cord Injuries
MeSH terms: Urinary Tract Infections; Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to assess the safety and feasibility of administering
      glycosaminoglycan (GAG) therapy, iAluRil®, intravesically in individuals with acute spinal
      cord injury (SCI), commencing within the first ten days of injury, to prevent early urinary
      tract infections.
    

Detailed description: 
      iAluRil®, listed as a medical device on the Australian Therapeutic Goods Registry (ATGR),
      contains both hyaluronic acid and chondroitin sulphate. This trial utilises iAluRil® for the
      same clinical indication as it is listed for on the ATGR, i.e. to re-establish the
      glycosaminoglycan (GAG) layers of the urothelial vesical tissue in cases in which their loss
      can cause problems, such as recurrent urinary tract infection in neurologically intact
      populations, but in a specific and vulnerable patient population (acute SCI). The trial will
      demonstrate the safety and feasibility of providing a series of iAluRil® treatments in early
      acute SCI, and provide an indication of effectiveness to prevent early urinary tract
      infections (compared to current standard infection control), informing researchers about the
      suitability of conducting a large randomised controlled clinical trial with this
      intervention.

      An 'Intervention post-UTI' arm for eligible inpatients and outpatients with SCI who have
      significant recurrent UTIs, will allow equivalent data collection and observations, informing
      researchers about a trial to reduce UTI recurrence during sub-acute/chronic SCI.
      Additionally, these patients will self-administer iAluRil® treatments providing data on the
      feasibility of SCI patients self-administering iAluRil® treatments.
    

Intervention name(s): iAluRil® intravesical instillations
Intervention type(s): Device
Intervention description(s): 50ml of a sterile solution of sodium hyaluronate (1.6% 800mg/50ml) and sodium chondroitin sulphate (2% - 1 g/50ml) is administered intravesically (directly into the bladder) via a pre-filled syringe connected to a catheter and held in the bladder for at least 30 minutes.
Other intervention name(s): Intravesical glycosaminoglycan (GAG) therapy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Consenting participants meeting eligibility criteria will join the intervention arm of trial; participants not meeting eligibility criteria and/or unwilling to receive intervention but consenting for data collection on bladder health measures for the study duration will join the non-intervention (standard care only) arm of trial.
Masking: None (Open Label)
Primary purpose: Prevention
CICATRIX in the Treatment of Recent Post-surgical Scars
Condition: Post-surgical Scars
MeSH terms: Cicatrix
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to assess the efficacy of CICATRIX (Asian Gotu Kola or Pennywort)
      usage in the treatment of recent post-surgical scars. The duration of this double-blind
      placebo controlled phase 3 clinical trial will be 4 weeks. The estimated number of persons to
      be recruited and randomized for the study is 90.
    


Intervention name(s): Cicatrix; Placebo
Intervention type(s): Other; Other
Intervention description(s): Dosage commensurate with surface to be treated. After washing and drying the affected area, a thin layer of CICATRIX (Topical use) will be applied on the lesion rubbing in different directions for 2 minutes, three times a day, for 4 weeks.; Dosage commensurate with surface to be treated. After washing and drying the affected area, a thin layer of PLACEBO (Topical use) will be applied on the lesion rubbing in different directions for 2 minutes, three times a day, for 4 weeks.
Other intervention name(s): Cosmetic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Post-surgical scars; Asian Gotu Kola; Asian Pennywort
Dexmedetomidine Pharmacokinetics in the Obese
Condition: Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to characterize, using two different modeling approaches, one based
      on purely statistic concept and one using a more mechanistic analysis, the influence of body
      weight and composition on the pharmacokinetic of dexmedetomidine.
    

Detailed description: 
      Twenty obese patients and 20 non-obese patients scheduled for elective laparoscopic surgery
      will give dexmedetomidine 0.5 μg.kg-1 over 10 minutes and then randomized to either
      dexmedetomidine 0.25 mcg.kg-1.h-1 or dexmedetomidine 0.5 mcg.kg-1.h-1 for approximate 2 h
      (range 58-320 min). Blood samples will be taken at 2, 5, 10, 15, 20, 30, 45, 60, 90, 120 min
      after beginning dexmedetomidine administration, and at 0, 2, 5, 10, 20, 30, 60, 90, 120, 240
      and 360 min after stopping infusion. Population pharmacokinetic modeling will be performed
      using nonlinear mixed-effects model.
    

Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): Dexmedetomidine administered intravenously
Other intervention name(s): Other names:; Precedex
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Anaesthetics iv; Dexmedetomidine; Pharmacokinetic
A Study to Assess SOM230 in Patients With Pituitary Cushing's Disease
Condition: Cushing's Syndrome
MeSH terms: ACTH-Secreting Pituitary Adenoma; Pituitary ACTH Hypersecretion; Cushing Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The study treatment period is 15 days in length and includes patients with pituitary
      Cushing's disease who are candidates for surgical intervention as well as and patients who
      have recurrent Cushing's post operatively.
    


Intervention name(s): SOM230 s.c.
Intervention type(s): Drug
Intervention MeSH terms: Pasireotide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Stellate Ganglion Block to Reduce Hot Flushes
Condition: Hot Flash; Stellate Ganglion Block; Postmenopausal; Hot Flushes
MeSH terms: Ganglion Cysts; Synovial Cyst; Hot Flashes
Study type: Interventional

Summary: 
      To assess the short-term efficacy of stellate ganglion block on hot flush reduction versus
      sham procedure
    

Detailed description: 
      Hot flushes are the most common symptom of menopause for which postmenopausal (PMP) women
      seek medical help, in 20% of PMP women hot flushes can persist for up to 15 years.

      A possible treatment for hot flushes is stellate ganglion block (SGB), used as a means to
      interrupt parts of the sympathetic nervous system involved in temperature regulation.

      Single centre randomized double blind placebo controlled intervention study Study period of 6
      months in which patients will fill out on set time points 5 questionnaires regarding quality
      of life and keep a diary on hot flush frequency and severity during1 week on the same time
      points.

      Study population:

      Postmenopausal women aged 30-70 years old with no other causes of flushing present.
      Intervention (if applicable) Intervention: Stellate ganglion block versus sham procedure

      Follow up with questionnaires during 6 months.
    

Intervention name(s): Bupivacaine block; Placebo ganglion block
Intervention type(s): Procedure; Procedure
Intervention description(s): stellate ganglion bupivacaine injection; stellate ganglion sodium chloride injection
Other intervention name(s): Stellate ganglion Block; stellate ganglion natrium chloride 0.9% injection
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment