bioihbjkbjnl/mcl2 huggingface dataset:
The Impact of COVID-19 Outbreak on Trans-population's Health in Italy
Condition: Transgender Persons; Coronavirus; Coronavirus Infection; COVID; COVID-19
MeSH terms: COVID-19; Coronavirus Infections
Study type: Observational

Summary: 
      During the COVID-19 outbreak, it was necessary to remodel the healthcare offer for all
      categories of subjects in order to minimize unnecessary movements of people while maintaining
      an adequate level of assistance. This is also true for transgender people, who are
      periodically requested to come into the clinic for hormonal therapy monitoring and
      continuation. In our center telemedicine programs dedicated to users have been activated for
      the remote management of hormone therapy.

      We use a web-based survey to assess the impact of COVID-19 outbreak on trans-population
      health and to assess the specific needs of this population in this particular moment.
    

Detailed description: 
      Use of a dedicated web-based anonymous questionnaire to assess health needs of
      trans-population during COVID-19 outbreak and to assess specific risk factors for COVID-19
      infection.

      Evaluation of physical and psychological wellbeing of the trans-population during COIVD-19
      outbreak in Italy using anonymous validated questionnaires (SF12, IES-R and BECK DEPRESSION
      INVENTORY)
    

Intervention name(s): web based survey
Intervention type(s): Other
Intervention description(s): Assess specific health care needs for the transpopulation during the COVID-19 outbreack using a newly created questionnaire and some validated questionnaries (Impact of Event Scale-Revised, BECK Depression Inventory and the Self-rated Health SF-12)
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        transgender population
Safety and Efficacy of VAY736 in Patients With Primary Sjogren's Syndrome (pSS)
Condition: Primary Sjogren Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will determine the dose-response relationship of VAY736 for key efficacy and
      safety parameters
    


Intervention name(s): VAY736; Placebo
Intervention type(s): Biological; Other
Intervention description(s): VAY736; Placebo control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Sjogren; VAY736; ianalumab; pSS
Effect of N-Acetylcysteine on Neutrophil Lymphocyte Ratio And Length of Stay In COVID-19 Patients
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This research is a study that compares the administration of N-acetylcysteine at various
      doses with the outcomes of COVID-19 patients, namely the neutrophil-to-lymphocyte ratio and
      length of stay.
    

Detailed description: 
      This research was an observational analytic cohort retrospective study in which the subjects
      were moderate degree COVID-19 inpatients in Sebelas Maret University Hospital divided into
      four groups. The control group K0 received standard therapy without NAC, while the treatment
      group K1 received NAC injections of 1200mg/day, K2 NAC tablets 3x400mg/day, and K3 NAC
      tablets 3x200mg/day. Different tests using Way ANOVA and LSD or Kruskal-Wallis and
      Mann-Whitney.
    

Intervention name(s): N-acetyl cysteine
Intervention type(s): Drug
Intervention description(s): N-acetyl cysteine dosage 600 mg and 1200 mg
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: This research was an observational analytic cohort retrospective study in which the subjects were moderate degree COVID-19 inpatients in Sebelas Maret University Hospital divided into four groups. The control group K0 received standard therapy without NAC, while the treatment group, K1, received NAC injections of 1200mg/day, K2 NAC tablets 3x400mg/day, and K3 NAC tablets 3x200mg/day. Different tests using Way ANOVA and LSD or Kruskal-Wallis and Mann-Whitney.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate BMS-986165 to assess its effects in participants with systemic
      lupus erythematosus (SLE).
    


Intervention name(s): BMS-986165; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Deucravacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Prohepcidin, Inflammation and Iron Homeostasis in Hemodialysis Patients With Chronic Hepatitis C
Condition: Renal Failure Chronic Requiring Hemodialysis; Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Kidney Failure, Chronic; Inflammation
Study type: Observational

Summary: 
      The aim of this study is to address questions regarding the link among hepcidin,
      hematological iron markers, inflammation and hepatitis C in HD patients. In attempt to
      address this issue, we planned to measure serum levels of hepcidin prohormone (pro-hepcidin),
      inflammatory and iron parameters.
    

Detailed description: 
      Hepatitis C virus (HCV) infection is the most common cause of chronic liver disease in the
      world and also common among chronic hemodialysis (HD) patients. Patients with chronic HCV
      often have increased liver iron, a condition associated with reduced sustained response to
      antiviral therapy, more rapid progression to cirrhosis, and development of hepatocellular
      carcinoma; however, little is known about the mechanism of iron accumulation in the liver.
      Recently identified hepcidin, a 25-amino acid peptide hormone exclusively synthesized in the
      liver, is thought to be a key regulator for iron homeostasis and is induced by infection and
      inflammation. Hepcidin expression is modulated by iron stores, so that it decreases in iron
      deficiency to facilitate iron absorption while it increases in iron repletion to prevent
      pathological overload. Interleukin (IL)-6 has been proposed as a major inducer of hepcidin,
      via direct transcriptional activation of hepatic hepcidin expression by binding to its
      receptor complex containing gp130 to activate janus kinase (JAK) and activator of
      transcription 3 (STAT 3).
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients on chronic hemodialysis
      
Keywords: hemodialysis; hepatitis C; inflammation; iron stores; prohepcidin
Long-Term Comparison of Fixed- and Mobile-Bearing Total Knee Arthroplasties (TKAs) in Patients With OA ≤50 Years Old
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the prospective study was to evaluate the minimum fifteen year follow-up of
      prospective total knee arthroplasties performed in patients younger than fifty years of age
      with osteoarthritis, using fixed- and mobile-bearing knee prostheses in the same patients, to
      compare

        1. functional scores

        2. rates of radiographic failure

        3. revision rates

        4. survivorship
    

Detailed description: 
      The randomized prospective comparison of fixed- and mobile-bearing total knee designs in the
      same patients younger than fifty years of age is limited. The purpose of this study was to
      compare the long-term clinical and radiographic results of fixed- and mobile-bearing total
      knee arthroplasties in patients younger than fifty years of age with osteoarthritis.
    

Intervention name(s): anatomic modular fixed-bearing; low contact stress rotating platform mobile-bearing
Intervention type(s): Device; Device
Intervention description(s): anatomic modular (AMK; DePuy) fixed-bearing prosthesis; low contact stress rotating platform (LCS RP; DePuy) mobile-bearing prosthesis
Other intervention name(s): AMK; LCS RP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: total knee arthroplasty; fixed-bearing; mobile-bearing; long-term
A Randomized, Double-Blind Trial Comparing the Efficacy and Safety of Fenofibrate, Metformin, Their Combination and Placebo in Patients With Metabolic Syndrome.
Condition: Patients With Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to study the effect of different combinations of fenofibrate
      and metformin on the cluster of metabolic syndrome (MetS) biochemical abnormalities, and to
      determine the dose combination allowing normalization of MetS patients.
    


Intervention name(s): Fenofibrate /Metformin; Fenofibrate /Metformin; Fenofibrate /Metformin; Fenofibrate /Metformin; Fenofibrate /Metformin; Fenofibrate /Metformin; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): fenofibrate 2 x 40 mg bid + metformin 850 mg bid (F160-M1700); fenofibrate 2 x 40 mg bid + metformin 500 mg bid (F160-M1000); fenofibrate 40 mg bid + metformin 850 mg bid (F80-M1700); fenofibrate 40 mg bid + metformin 500 mg bid (F80-M1000); fenofibrate 2 x 40 mg bid + metformin placebo (F160-M0); fenofibrate placebo + metformin 850 mg bid (F0-M1700); Placebo
Intervention MeSH terms: Metformin; Fenofibrate
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes; Hypertriglyceridaemia; Metabolic Syndrome
ArcticLine Feasibility Study
Condition: Atrial Fibrillation; Atrial Flutter
MeSH terms: Atrial Fibrillation; Atrial Flutter
Study type: Interventional

Summary: 
      The purpose of the ArcticLine Feasibility Study is to collect preliminary safety and
      effectiveness data on the ArcticLine Catheter.
    


Intervention name(s): ArcticLine Cardiac Cryoablation Catheter
Intervention type(s): Device
Intervention description(s): Cryoablation
Other intervention name(s): Arctic Front Advance Cardiac Cryoablation Catheter; Freezor MAX Cardiac Cryoablation Catheter; FlexCath Advance Steerable Sheath
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
A Safety and Efficacy Study of Escitalopram on Acute Treatment of Severe Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of escitalopram treatment in
      participants with severe major depressive disorder (MDD [marked depression appearing in the
      involution period and characterized by hallucinations, delusions, paranoia, and agitation]).
    

Detailed description: 
      This is a single-arm (clinical study in only one group of participants), open-label (all
      people know the identity of the intervention), multi-center (when more than one hospital or
      medical school team work on a medical research study), and prospective (study following
      participants forward in time) study. The study consists of 2 parts: Screening (that is, 5
      days before study commences on Day 1) and Treatment (that is, Week 1-8). All the eligible
      participants will be receiving flexible doses of escitalopram orally in the dose range of 10
      to 20 milligram per day (mg/day) for 8 weeks. Efficacy will primarily be evaluated by
      remission rate at the end of the study. Participants' safety will be monitored throughout the
      study.
    

Intervention name(s): Escitalopram
Intervention type(s): Drug
Intervention description(s): Escitalopram tablets will be administered orally in the dose range of 10 to 20 milligram per day (mg/day) for 8 weeks. Dose can be adjusted as per Investigator's discretion depending on participant's response.
Other intervention name(s): Lexapro
Intervention MeSH terms: Escitalopram
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Escitalopram; Lexapro
Study Evaluating the Effect of Food on the Pharmacokinetics of Palovarotene and the Effect of Palovarotene on the Pharmacokinetics of the CYP3A4 Substrate Midazolam in Two Cohorts of Healthy Adult Subjects
Condition: Fibrodysplasia Ossificans Progressiva
MeSH terms: Myositis Ossificans
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to evaluate the effect of food and the effect of swallowing capsule whole versus
      sprinkling on apple sauce on the pharmacokinetics (PK)/bioavailability of palovarotene, and
      evaluate the effect of palovarotene on the PK of the CYP3A4 substrate midazolam.
    


Intervention name(s): Palovarotene; midazolam
Intervention type(s): Drug; Drug
Intervention description(s): oral capsules; oral syrup
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study had two components. One component evaluated the effect of food and the effect of swallowing capsule whole versus sprinkling on apple sauce on the PK/bioavailability of palovarotene, and the other component evaluated the effect of palovarotene on the PK of the CYP3A4 substrate midazolam. The PK of palovarotene after single and multiple doses was also evaluated as part of the DDI component. Two cohorts of healthy adult subjects were enrolled, one for each component.
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Immunogenicity in Dose-Ranging and Formulation-Finding Meningococcal B (MenB) Vaccine Study in 2-month-old Infants
Condition: Meningococcal Meningitis; Meningococcal Infections
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is aimed at assessing the safety and immunogenicity of different doses and
      formulations of a new Novartis Meningococcal B Recombinant Vaccine.
    


Intervention name(s): Meningococcal B vaccine; Meningococcal B vaccine; Meningococcal B vaccine; Meningococcal B vaccine; Meningococcal B vaccine; Meningococcal B vaccine; Control; Meningococcal B vaccine with antipyretic
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Vaccine candidate formulation I; Vaccine candidate formulation II; Vaccine candidate formulation III; Vaccine candidate formulation IV; Vaccine candidate formulation V; Vaccine candidate formulation VI; Control; Vaccine candidate formulation I with antipyretic
Intervention MeSH terms: Antipyretics; Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Immunogenicity; Meningitis; Antibody; Infants
Year 3 Extension for Efficacy Follow-up in Subjects Vaccinated in Studies Rota-028, 029 or 030 (NCT00197210)
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This Year 3 extension of the main study rota-028, 029 or 030 is conducted to evaluate vaccine
      efficacy against severe rotavirus (RV) gastroenteritis (GE) during third year of life in
      infants previously vaccinated with human rotavirus (HRV) vaccine or placebo in the following
      schedules:

      at 3 and 4 months of age in study rota-028; at 2 and 4 months of age in study rota-029 or
      rota-030.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Detailed description: 
      Note that no new subjects will be recruited in this extension phase studies.

      The expected total enrolment for the primary studies was as follows:

      rota-028: 5700 rota-029: 3018 rota-030: 1102
    

Intervention name(s): Rotarix™; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Oral administration, 2 doses; Oral administration, 2 doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Rotavirus Gastroenteritis; Human rotavirus vaccine, efficacy, infants
The Effectiveness of LSVT-BIG Training in Improving Balance and Gait in Parkinson's Patients
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Parkinson's disease (PD) is a chronic, progressive disease that causes motor and non-motor
      symptoms due to dopaminergic neuron loss. Today, the treatment of PD in addition to optimal
      medical and surgical treatments, physiotherapy and rehabilitation approaches have an
      important place in the treatment. Recently, it has been stated that intensive rehabilitation
      interventions in the field of physiotherapy and rehabilitation can be more effective than
      traditional rehabilitation approaches. Lee Silverman VoiceTreatment- BIG (LSVT-BIG) is a
      high-intensity exercise model aimed at improving bradykinesia and hypokinesia in PD. There
      are many studies showing improvements in balance, walking, motor performance, reaching
      ability, postural control, quality of life and cognitive status after LSVT-BIG training in
      PD. However, it is seen that there is no study investigating the effect of LSVT-BIG training
      directly by applying it as a home program. For this reason, there is a need for studies
      investigating whether this intensive treatment method can be an alternative to the clinical
      environment by applying it as a home program.
    

Detailed description: 
      This study is planned as a randomized control trial. Patients will be randomly divided into
      two groups a clinical group and a home group. The clinical group will be received LSVT-BIG
      training four times a week for four weeks in the clinic. The home group will be received
      LSVT-BIG training two times a week for four weeks at the home and two times a week for four
      weeks at the clinical.

      All assessments will be done before and after the 4-week intervention program or waiting
      period. The demographic characteristics of the participants initially will be taken. The
      outcome measures are balance and gait assessments.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Both groups will receive exercise-based training
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups as clinical group and home group
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson Disease; LSVT-BIG Training; Home Based Exercise; Balance; Walking
Epidural Neostigmine for Labor Pain
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to see which dose of epidural neostigmine is the best additive
      to use with the numbing medication used in an epidural during labor.
    

Detailed description: 
      This study is examining the use of the non-narcotic medication, neostigmine, in combination
      with the local anesthetic bupivacaine when compared with the commonly used narcotic fentanyl
      in providing pain relief with the fewest side effects in labor analgesia.
    

Intervention name(s): Neostigmine; Bupivacaine; fentanyl
Intervention type(s): Drug; Drug; Drug
Intervention description(s): utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.; fentanyl 2 mcg/ml
Intervention MeSH terms: Fentanyl; Bupivacaine; Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: non narcotic; epidural; labor pain; Non narcotic treatment of labor pain
Effects of Prevention in School (PS): a Swedish School-wide Positive Behavior Support Program at the Primary Prevention Level
Condition: Problem Behaviors Among Students; Classroom Learning Environment
MeSH terms: Problem Behavior
Study type: Interventional

Summary: 
      Prevention in School (PS) is a modified School-Wide Positive Behavior Support Program at the
      universal prevention level, developed by Swedish researchers for the school years 4 -9. By
      defining and teaching school rules to all teachers and students, and by consistently
      acknowledging students when meeting behavioural expectations, the program aims to reduce
      problem behaviours in school areas and to improve the classroom learning climate. Against
      this background, the purpose of this study is to examine whether PS is more effective than
      schools' ordinary practices in meeting these goals.
    


Intervention name(s): PS - Prevention in School
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention