bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 1 Study of MEDI7734 in Type I Interferon-Mediated Autoimmune Diseases
Condition: Dermatomyositis, Polymyositis, Sjogren's, SLE, SSc
MeSH terms: Dermatomyositis; Polymyositis; Autoimmune Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and tolerability of escalating, single subcutaneous doses of MEDI7734
      in adult subjects with type I interferon-mediated autoimmune diseases.
    

Detailed description: 
      MEDI7734 is a human monoclonal antibody that binds to and causes temporary depletion of
      plasmacytoid dendritic cells (pDCs), a type of white blood cell. The objectives of this study
      are to evaluate the safety, drug levels, and pDC levels in subjects who are given a single
      injection of MEDI7734 or a placebo.

      The study will be conducted in subjects with at least one of the five following autoimmune
      diseases: dermatomyositis, polymyositis, Sjogren's syndrome, systemic lupus erythematosus, or
      systemic sclerosis.

      After a screening period, subjects will be randomized in a 3:1 ratio to receive a single dose
      of MEDI7734 or matching placebo, administered as a subcutaneous (under the skin) injection.
      After that, subjects will be evaluated periodically at the study site over at least the next
      85 days.
    

Intervention name(s): MEDI7734; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Three subjects (cohort 1) and six subjects (cohort 2-5) will receive MEDI7734 for a total of 27 subjects.; One subject (cohort 1) and two subjects (cohort 2-5) will receive placebo, for a total of 9 subjects.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Polymyositis, dermatomyositis, Sjogren's syndrome, SLE, SSc
A Clinical Study to Investigate the Effect of an Investigational Drug as an Added Medication to an Antipsychotic, in Adults With Schizophrenia, as Measured Positron Emission Tomography (PET) Imaging
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      A clinical study to investigate the effect of an investigational drug as an added medication
      to an antipsychotic, in adults with schizophrenia, as measured positron emission tomography
      (PET) imaging . This study is accepting male and female participants between 18 years old -45
      years old who have been diagnosed with schizophrenia. This study will be conducted in 2
      locations in the UK. The study will last approximately 14 months.
    

Detailed description: 
      This is a single-site, open-label, flexibly-dosed study evaluating the effect on brain
      dopamine synthesis capacity as measured by 18F-DOPA PET imaging of adjunctive open-label
      administration of SEP-363856 (50 to 75 mg/day) over 2 weeks in adults with schizophrenia. The
      study will consist of 3 periods: Screening (up to 28 days), Treatment (2 weeks), and a
      Follow-up visit
    

Intervention name(s): SEP-363856
Intervention type(s): Drug
Intervention description(s): SEP-363856 50mg, 75mg flexable dosing, dosed once daily capsule
Intervention model: Single Group Assignment
Intervention model description: This is a single-site, open-label, flexibly-dosed study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: schizophrenia
Trial to Evaluate the Efficacy of Fluvastatin on Certain Markers
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 4

Summary: 
      To analyze efficacy of fluvastatin on patients with chronic renal disease by analyzing
      certain inflammatory markers. In addition, tolerability and safety will also be evaluated in
      a Spanish population.
    


Intervention name(s): Fluvastatin
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Dyslipidemia, chronic renal disease, fluvastatin
Medical Supervised Duodenal-Enteral Feeding Treatment
Condition: Obesity; Obesity, Visceral; Overweight and Obesity; Body Fat Disorder; Feeding and Eating Disorders; Hormone Disturbance; Weight Loss
MeSH terms: Obesity; Overweight; Obesity, Abdominal; Endocrine System Diseases; Weight Loss; Feeding and Eating Disorders
Study type: Interventional

Summary: 
      Medical Supervised Duodenal-Enteral Feeding for Overweight, Obesity and Increased Body Fat
      Percentage Treatment based on an intervention procedure performed by a Licensed Nutritionist
      Doctor for weight loss and loss of fat percentage in patients who need it.
    

Detailed description: 
      Medical Supervised Duodenal-Enteral Feeding for Overweight, Obesity and Increased Body Fat
      Percentage Treatment based on an intervention procedure performed by a Licensed Nutritionist
      Doctor for weight loss and loss of fat percentage in patients who need it. The feeding is by
      nasogastric-duodenal tube depending on the desired fat loss and / or weight in relation to
      the basal metabolism. Feeding by tube of 12-29 days, continuing with personalized nutritional
      treatment for 2 weeks and physical activity during the protocol. Losses of weight and / or
      expected fat greater than 10%. The results will be compared with bariatric surgery. The main
      objective is to provide a tool for the obesity epidemic that can be applied worldwide by
      doctors without the complications of surgery and with a lower price for health systems and
      controlling the actions of the hormones leptin and ghrelin.
    

Intervention name(s): Nasogastroduodenal Protocol; Control; Data analysis
Intervention type(s): Dietary Supplement; Other; Other
Intervention description(s): Complete nutrition (carbohydrates, lipids, proteins, vitamins, oligoelements); Progress registration of body composition values; Statistical analysis of all data
Other intervention name(s): Medical-Clinical-Nutrition assessment; Progress; Statistics
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Duodenal-Enteral medical supervised feeding response
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; overweight; fat percentage; body fat; enteral feeding; fat loss
Multiple-Ascending Dose Study
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and tolerability of BMS-820836 after
      multiple doses
    


Intervention name(s): BMS-820836; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral Solution, Oral, 0.1 mg to 4 mg, Once daily, 14 days; Oral Solution, Oral, 0 mg, Once daily, 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which
      is a drug that lowers blood sugar. The study will look at how the body processes LY900014,
      and the effect of LY900014 on blood sugar levels following a standard meal. For each
      participant, the study will consist of 4 periods and there will be approximately 12 weeks
      from screening to final study follow up.
    


Intervention name(s): LY900014; Insulin Lispro
Intervention type(s): Biological; Biological
Intervention description(s): Administered SC; Administered SC
Other intervention name(s): Ultra-Rapid Lispro; LY275585; Humalog
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Pinless-Navigated Versus Conventional Total Knee Arthroplasty
Condition: Arthropathy of Knee
MeSH terms: Joint Diseases
Study type: Interventional

Summary: 
      The success of total knee arthroplasty depends on a number of factors including pre-operative
      range of movement, obesity, medical comorbidities, prosthesis design, preparation and
      implantation of the prosthesis, soft tissue balancing, as well as implants alignment. Optimal
      placement of the implants within 3° of the mechanical axis of the lower limb has been proven
      to reduce wear and early implant failure.

      Compared to conventional techniques, computer-Aided Navigation total knee arthroplasty has
      been widely used in the last decade and have been proven to improve the accuracy of
      prosthesis placement and lower limb alignment by reducing the number of outliers with more
      than 3° deviation from the mechanical axis. However, its use also involves a steep learning
      curve, high initial capital cost and longer duration of surgery.

      Traditional computer-navigated TKA using optical tracking systems also requires fixation of
      the femoral and tibial reference arrays to bone using anchoring pins. Complications reported
      with the use of these pins include either femoral or tibial fracture, pin site pain, pin site
      infection and osteomyelitis. The investigators study aims to investigate the accuracy of a
      new pinless navigation system for TKA that will avoid these complications.
    

Detailed description: 
      The duration of surgery and length of hospital stay were recorded for all patients. Three
      radiographic measurements were recorded on the coronal films: 1) Hip-Knee-Ankle Angle (HKA),
      the angle formed by the mechanical axis of the femur (line between the centre of the femoral
      head and the centre of the knee) and the mechanical axis of the tibia (line between the
      centre of the talus and the centre of the knee); 2) Coronal Femoral-Component Angle (CFA),
      the angle formed by the femoral component and the mechanical axis of the femur; 3) Coronal
      Tibia-Component Angle (CTA), the angle formed by the tibia base plate and the mechanical axis
      of the tibia. The post-operative radiographic measurements were compared with the
      intra-operative readings from the pinless navigation system. The accepted values used in our
      study for normal alignment were: 1) 0° ± 3° varus/valgus for HKA; 2) perpendicular (± 3°) to
      the mechanical axis of the femur; 3) perpendicular (± 3°) to the mechanical axis of the
      tibia.
    

Intervention name(s): Pinless-Navigated Total Knee Arthroplasty; Conventional Total Knee Arthroplasty
Intervention type(s): Procedure; Procedure
Intervention description(s): Brainlab VectorVision Knee 2.5 Navigation System; Conventional technique.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Total Knee Replacement, Computer-Assisted Surgery
Treatment of Adolescent Antimuscarinic (Anticholinergic) Toxidrome
Condition: Anticholinergics Toxicity
Study type: Interventional
Phase: Phase 4

Summary: 
      Overdose of xenobiotics (antihistamines, antipsychotics, or Jimson Weed) with resulting
      antimuscarinic toxidrome is a common scenario in medical toxicology. The result of antagonism
      of muscarinic receptors is a constellation of signs and symptoms (toxidrome): mydriasis,
      decreased sweat, decreased bowel sounds, agitation, delirium, hallucinations, urinary
      retention, tachycardia, flushed skin and seizures. Two treatment options are physostigmine or
      benzodiazepines.

      Although the antimuscarinic toxidrome occurs commonly, physostigmine has been used sparingly
      despite evidence of safety and efficacy. To demonstrate the utility and safety of
      physostigmine, the investigators propose a randomized clinical trial of physostigmine
      compared to benzodiazepine for antimuscarinic toxicity.
    


Intervention name(s): Physostigmine; Lorazepam
Intervention type(s): Drug; Drug
Intervention description(s): Administration of physostigmine bolus followed by an infusion; Administration of lorazepam bolus followed by normal saline infusion
Intervention MeSH terms: Lorazepam; Physostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Stress Induced by Screening for Retinopathy of Prematurity - Should Speculum and Indentation Rather be Avoided
Condition: Retinopathy of Prematurity
MeSH terms: Retinal Diseases; Retinopathy of Prematurity; Premature Birth
Study type: Interventional

Summary: 
      The purpose is to assess the hypothesis that indirect ophthalmoscopy for retinopathy of
      prematurity eye examination (ROPEE) screening without the use of a lid speculum and scleral
      indentation (speculum-free, SpF) is less painful/stressful than funduscopy with speculum (Sp)
      and scleral indentation.
    

Detailed description: 
      A prospective randomized cross-over study was conducted for the comparison of the two
      techniques of funduscopy for ROPEE screening, i.e. with (Sp) or without (SpF) the use of a
      speculum and indentor. A random number table was used to allocate participants into either a)
      receiving Sp funduscopy on their first and SpF on their second screening examination a week
      later, or b) receiving SpF first and Sp a week later.
    

Intervention name(s): Speculum-free (SpF) fundoscopy; Speculum (Sp) fundoscopy
Intervention type(s): Other; Other
Intervention description(s): Indirect ophthalmoscopy without the use of eyelid speculum and scleral indentation; Indirect ophthalmoscopy with the use of eyelid speculum and scleral indentation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Screening
PK and Safety of Midostaurin in Subjects With Impaired Hepatic Function and Subjects With Normal Hepatic Function
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this international study was to assess the effect of varying degrees of
      impaired hepatic function compared to a normal hepatic function (Child-Pugh classification)
      on the pharmacokinetics and safety of midostaurin.
    

Detailed description: 
      Midostaurin was developed for the treatment of patients with hematological and
      nonhematological malignancies. However, disease complications and various co-medications made
      it difficult to perform a hepatic impairment study in the targeted patient population.

      Metabolism and elimination of midostaurin predominantly occurs in the liver. Patients with
      impaired hepatic function may have a higher risk to have a decreased elimination or
      metabolism of midostaurin which may lead to increased systemic exposure or toxicity, hence
      understanding the impact of an impaired hepatic function on midostaurin PK is important.

      Cumulative safety data from over 900 subjects exposed to midostaurin showed that the drug was
      well tolerated in patients and in healthy subjects, thus, it was appropriate and justifiable
      to study midostaurin in subjects with varying degrees of hepatic impairment.

      Due to the difficulty in enrolling subjects with severe hepatic impairment, an interim
      analysis was performed when all mild and moderate hepatic impaired subjects, and the
      respective control subjects, had completed the trial, in order to obtain interim results on
      the PK and safety of midostaurin in patients with mild and moderate hepatic impairment. The
      protocol was amended in April 2018 to make the inclusion / exclusion criteria more fitting
      with enrolling the severe hepatic impairment group. The final study analysis was performed
      when all severe hepatic impaired subjects, and the matching controls, had completed the
      study.
    

Intervention name(s): Midostaurin; Midostaurin
Intervention type(s): Drug; Drug
Intervention description(s): Midostaurin 25 mg soft gelatin capsules (2 capsules). The midostaurin capsules will be administered orally with 240 mL of non-carbonated water in the morning (between 8-10 AM), and in the evening (after a 12 hour break) from Day 1 to Day 6. On Day 7, midostaurin will be administered in the morning only (between 8-10 AM).; Midostaurin 25 mg soft gelatin capsules (2 capsules). The midostaurin capsules will be administered orally with 240 mL of non-carbonated water in the morning (between 8-10 AM) on Day 1 only.
Other intervention name(s): PKC412; PKC412
Intervention MeSH terms: Midostaurin; Staurosporine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Hepatic impaired patients; Healthy volunteers; Varying degrees of hepatic impairment
CT and Clinical Features of Internal Hernia
Condition: CT Images of Internal Hernia; Clinical Outcomes
MeSH terms: Hernia; Internal Hernia; Hernia, Abdominal
Study type: Observational

Summary: 
      Researchers retrospectively reviewed patients with internal hernia that confirmed by surgical
      exploration between Feb. 2012 and Feb. 2018. and analysis the Medical records and MDCT images
      to investigate the clinical and radiological features of internal hernia.
    

Detailed description: 
      51 Patients with definite diagnosis of IH during surgical exploration from Feb. 2012 to Feb.
      2018 in our hospital were included in this research. Medical records including MDCT images
      and intra-operative findings were collected retrospectively. The CT features of different
      subgroups were also evaluated.
    

Intervention name(s): Multi-detector CT scan
Intervention type(s): Diagnostic Test
Intervention description(s): This is a diagnostic radiological test to diagnose the IH and evaluate the clinical condition of IH
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All Patients with definite diagnosis of IH during surgical exploration from Feb. 2012 to
        Feb. 2018 in our hospital were included in this research
Fetal Doppler and Uterine Artery Blood Volume Correlation.
Condition: Fetal Doppler; Uterine Blood Flow
Study type: Observational

Summary: 
      To investigate the relationship between uterine artery blood volume and fetal doppler indices
      at the delivery.
    

Detailed description: 
      Introduction: To investigate the relationship between uterine artery blood volume and fetal
      doppler indices at the delivery.

      Materials and Methods: This was a prospective cohort study of 50 nulliparous women booking
      antenatal care at the University of Campania "Luigi Vanvitelli" between May 2022 and
      September 2022. All full-term pregnancies accepted for delivery will include. Pregnant women
      with antepartum haemorrhage, stillbirths, multiple gestations, or congenital abnormalities
      were excluded. Women underwent a transabdominal ultrasound examination of uterine arteries
      for measurement of Uterine artery blood volume. Pregnancy outcomes were recorded, and linear
      regression was used to study the relationship between uterine artery blood volume and fetal
      Doppler indices. SPSS version 25 (Chicago, IL, USA) was used to code, tabulate, and analyze
      the data. Quantitative data were analyzed using the student's t-test. Qualitative data were
      analyzed using the Mann-Whitney test. A statistically significant difference was defined as a
      p-value of 0.05.
    

Intervention name(s): Ultrasound exam
Intervention type(s): Other
Intervention description(s): We included all full-term pregnancies accepted for delivery that received an accurate ultrasound scan before the birth
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Full-term pregnancies (37-42 weeks) comprised all pregnant women who would give birth at
        our hospital.
      
Keywords: Doppler; Pregnancy; ultrasound; uterine blood flow
A Phase IIa Study of NT-KO-003 for Multiple Sclerosis
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to assess the efficacy and safety of NT-KO-003 in the treatment of
      relapsing remitting multiple sclerosis, comparing two doses versus placebo.
    

Detailed description: 
      This is a Phase IIa study, double blind, placebo Controlled, Multicenter Study that will
      involve up to 99 patients with relapsing remitting multiple sclerosis.

      After signing the informed consent form, subjects will be randomized to three treatments
      arms: placebo, NT-KO-003 low dose or NT-KO-003 high dose. Treatment will continue daily
      during 6 months. A MRI and a clinical evaluation will be performed monthly. Safety will be
      assessed during the 6 months treatment and until 15 days after the finalization of the
      treatment.

      Patients will be allowed to continue in the same arm of the study, in a blinded way, until
      the study finalizes as optional extension treatment. Patient will sign the Extension Informed
      Consent and a MRI will be performed for those patients still in treatment after 12 months of
      the inclusion in the core study (visit 0).
    

Intervention name(s): NT-KO-003
Intervention type(s): Drug
Intervention description(s): NT-KO-003 is a coated tablet, administered once a day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: NT-KO-003; RRMS; efficacy; safety; Phase IIa
A Study to Evaluate the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effects on the single-dose drug levels of
      mavacamten in healthy participants.
    


Intervention name(s): Mavacamten
Intervention type(s): Drug
Intervention description(s): Specified dose on specified days
Other intervention name(s): BMS-986427; MYK-461
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mavacamten; Healthy Participants; Bioequivalence; Hypertrophic Cardiomyopathy