bioihbjkbjnl/mcl2 huggingface dataset:
Reliability and Validity of the Turkish Version of SMİLE-C
Condition: Covid19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      How the life style changed multidimensionally with home isolation in the period of COVID-19
      is a new research question. Physical and social isolation, home isolation, and quarantine
      policies applied during epidemic periods such as SARS, MERS, Ebola have been associated with
      lifestyle changes (Lippi, 2019). Much of the research on the health impact of epidemics and
      isolation has focused on psychological issues such as stress-related symptoms and disorders
      and to a lesser extent social support and stress management. In contrast, the epidemic and
      its associated lifestyle issues during quarantine and isolation, including the impact of
      dietary changes, restricted physical activity, and increased indoor and screen time, are
      still not investigated. A limited number of studies have examined lifestyle changes during
      COVID-19 and previous epidemic periods. However, there is no Turkish survey that
      comprehensively deals with the lifestyle, the scope of which is expanding, today. The Brief
      Multidimensional Lifestyle Assessment Scale, which we planned to validate in our study, is a
      scale developed by Balanzá-Martínez et al to multi-dimensionally evaluate the lifestyle
      changes that occurred during the COVID-19 outbreak. It consists of 7 parts (Diet and
      Nutrition, Substance addiction, Physical activity, Stress management, Restorative sleep,
      Social support and Environmental exposure) and a total of 27 items. There are response
      options measured using a 4-point Likert scale. High scores indicate a healthy lifestyle
      (Balanzá-Martínez, 2021).

      In this context, we think that adapting the Short Multidimensional Lifestyle Assessment Scale
      / Short Multidimensional Inventory Lifestyle Evaluation - Confinement (SMILE-C) questionnaire
      into Turkish will make a significant contribution to the literature.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        healthy people between 18-65 years old.
      
Keywords: Covid-19, pandemic, lifestyle
Noninvasive Monitoring in Lower Body Negative and Positive Pressure Tests
Condition: Hemorrhage
MeSH terms: Hemorrhage
Study type: Interventional

Summary: 
      The goal of these studies is to assess the use of phonocardiograhy to monitor blood volume.
      We will evaluate phonocardiographic parameters in normal subjects in increasing levels of
      lower body negative pressure (LBNP) and lower body positive pressure (LBPP).
    


Intervention name(s): Fluid shift
Intervention type(s): Device
Intervention description(s): We are using lower body negative and positive pressure to create a fluid shift in the body. This study is investigating if there are changes in phonocardiographic parameters related to changes in blood volume caused by this fluid shift
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Phonocardiogram
A Home-based Intervention to Promote Mindful Breathing Awareness Through Pursed-lip Breathing Training for COPD Patients
Condition: COPD; Emphysema
MeSH terms: Emphysema
Study type: Interventional

Summary: 
      In this study, a system will be developed to guide patients with chronic obstructive
      pulmonary disease (COPD) to complete a mindful breathing practice at home. COPD is the third
      leading cause of death in the United States and no cure exists. Shortness of breath is the
      most common disabling symptom. Pursed lips breathing is a type of breathing practice that has
      demonstrated effectiveness for patients with COPD. It requires practice to maintain and there
      is currently no home system to provide the needed feedback and support to maintain PLB.
      Additionally, syncing breathing and heart rate variation offers patients additional benefits.
      The proposed project explores the use of biofeedback to guide COPD patients in a breathing
      practice and to provide data for health coaching to monitor and support the practice.
    


Intervention name(s): mindful breathing application; application on a computer tablet
Intervention type(s): Behavioral; Device
Intervention description(s): Participants will use a mindful breathing application on a computer tablet.; a computer tablet
Intervention model: Single Group Assignment
Intervention model description: Pilot study
Masking: None (Open Label)
Primary purpose: Treatment
The HEADWIND Study - Part 4
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Hypoglycemia; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      To analyse driving behavior of individuals with type 1 diabetes in eu- and mild hypoglycaemia
      while driving in a real car. Based on the in-vehicle variables, the investigators aim at
      establishing algorithms capable of discriminating eu- and hypoglycaemic driving patterns
      using machine learning classifiers.
    

Detailed description: 
      Hypoglycaemia is among the most relevant acute complications of diabetes mellitus. During
      hypoglycaemia physical, psychomotor, executive and cognitive function significantly
      deteriorate. These are important prerequisites for safe driving.

      Accordingly, hypoglycaemia has consistently been shown to be associated with an increased
      risk of driving accidents and is, therefore, regarded as one of the relevant factors in
      traffic safety. Therefore, this study aims at evaluating a machine-learning based approach
      using in-vehicle data to detect hypoglycaemia during driving.

      During controlled eu- and hypoglycaemia, participants with type 1 diabetes mellitus drive in
      a driving school car on a closed test-track while in-vehicle data is recorded. Based on this
      data, the investigators aim at building machine learning classifiers to detect hypoglycemia
      during driving.
    

Intervention name(s): Controlled hypoglycaemic state while driving
Intervention type(s): Other
Intervention description(s): Participants will drive on a designated circuit with a real car on a test track accompanied by a driving instructor. Initially, a euglycaemic state (5.0 - 8.0 mmol/L) is established and blood glucose is then declined to hypoglycaemia (3.0 - 3.5 mmol/L) by administering insulin. Thereafter, blood glucose is raised again to euglycaemia (5.0 - 8.0mmol/L). During the procedure, driving data is recorded. Additionally, eye movement, head pose, facial expression, heart rate, skin conductance, and CGM values are recorded throughout the glycemic trajectory. Participants are blinded to the blood glucose values during the procedure.
Intervention MeSH terms: Hypoglycemic Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Automotive Technology; Hypoglycemia; Hypoglycaemia; Driving; Car
A Study of the Safety and Tolerability of Oral Ziprasidone in Children and Teens With Psychotic Disorders
Condition: Schizophrenia; Bipolar Disorder; Schizoaffective Disorder
MeSH terms: Schizophrenia; Bipolar Disorder; Psychotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of oral ziprasidone in
      children and teens with psychotic disorders
    


Intervention name(s): Ziprasidone; Ziprasidone
Intervention type(s): Drug; Drug
Intervention description(s): Period 1: Initial dose of oral ziprasidone suspension 20 mg twice daily, which was titrated up in 20 mg twice daily increments to a maximum dose of 80 mg twice daily by Day 10.
Period 2: patients could switch to oral capsules or remain on oral suspension; doses were flexibly titrated to between 10 and 80 mg twice daily based on the individual needs of the patient as determined by the investigator; concomitant antidepressants and/or mood stabilizers were allowed during Period 2 but not Period 1.; Period 1: Initial dose of oral ziprasidone suspension 10 mg twice daily, which was titrated up in 10 mg twice daily increments to a maximum dose of 40 mg twice daily by Day 10.
Period 2: patients could switch to oral capsules or remain on oral suspension; doses were flexibly titrated to between 10 and 80 mg twice daily based on the individual needs of the patient as determined by the investigator; concomitant antidepressants and/or mood stabilizers were allowed during Period 2 but not Period 1.
Other intervention name(s): Geodon, Zeldox; Geodon, Zeldox
Intervention MeSH terms: Ziprasidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Zolpidem (Myslee) Post Marketing Study in Adolescent Patients With Insomnia - Evaluation With Polysomnography
Condition: Insomnia; Sleep Initiation and Maintenance Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the efficacy of zolpidem for adolescent insomniacs with polysomnography
    

Detailed description: 
      The study consists of two parts. All patients will receive placebo in one part and Zolpidem
      in the other part in a single blind manner. Efficacy will be measured with polysomnography .
    

Intervention name(s): zolpidem
Intervention type(s): Drug
Intervention description(s): Oral
Other intervention name(s): Myslee
Intervention MeSH terms: Zolpidem
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: polysomnography; zolpidem; Sleep disorders; adolescent
(H.E.L.P.)Apheresis Therapy to Compare the Reduction of LDL (Low Density Lipoprotein) Cholesterol
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      The primary objective of the study is to demonstrate that the performance of the modified
      Plasmat® Futura H.E.L.P. Apheresis System is non-inferior to the current FDA approved
      Plasmat® Secura H.E.L.P Apheresis System for use under the approved indication of the acute
      reduction of LDL-cholesterol from the plasma in populations for whom diet has been
      ineffective and maximum drug therapy has either been ineffective or not tolerated.
    

Detailed description: 
      The primary study endpoint is the change in percent measurements of the pre-to-post apheresis
      LDL measurements between the approved H.E.L.P. system and the modified H.E.L.P. system. The
      secondary study endpoints are clinical lab profiles and device parameters analyzed at
      specific time points throughout the study.
    

Intervention name(s): Secura then Futura; Futura then Secura
Intervention type(s): Device; Device
Intervention description(s): Randomized to 6 bi-monthly H.E.L.P. therapy treatments with the Plasmat® Secura apheresis system and then cross over to receive 6 bi-monthly treatments with the Plasmat® Futura apheresis system.; Randomized to 6 bi-monthly H.E L.P. therapy treatments with the Plasmat® Futura apheresis system and then cross over to receive 6 bi-monthly treatments with the Plasmat® Secura apheresis system.
Intervention MeSH terms: Clotrimazole; Miconazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Heparin; Extracorporeal; Low Density Lipo-Protein (LDL) Cholesterol; Apheresis; Device
Complications in Central American Diabetic Patients: Historic Cohort
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Retrospective, observational study to determine the prevalence of complications in Central
      American diabetic patients.
    

Detailed description: 
      This is retrospective observational study aimed to determine the prevalence of complications
      in Central American diabetic patients. Patients included are treated in the usual outpatient
      practice setting and we will try to determine the prevalence of diabetic complications in
      these patients.
    

Intervention name(s): None, observational study
Intervention type(s): Other
Intervention description(s): None, it is an observational study
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients with type 2 diabetes mellitus
      
Keywords: diabetes mellitus; complications; prevalence
Efficacy, Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6-
      hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.
    

Detailed description: 
      Attention-Deficit/Hyperactivity Disorder (ADHD) is a psychiatric disorder characterized by 3
      main symptoms: inattention, hyperactivity and impulsivity. This study will assess the
      efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485
      in 6-12 year old subjects diagnosed with ADHD.
    

Intervention name(s): Methylphenidate Transdermal System; Placebo; Concerta
Intervention type(s): Drug; Drug; Drug
Intervention description(s): MTS 10mg/12.5cm2, 15mg/18.75cm2, 20mg/25cm2, and 30mg/37.5cm2 patch sizes; Placebo patch 10mg/12.5cm2, 15mg/18.75cm2, 20mg/25cm2, and 30mg/37.5cm2 patch sizes applied daily; CONCERTA® is available in doses of 18mg, 27mg, 36mg, 54mg, and 72mg tablets daily
Other intervention name(s): MTS; Sham Treatment; Methylphenidate HCL
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Working Memory Training in Adults With ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate whether computerised working memory training
      improves cognitive performance, ADHD symptoms, psychosocial functioning and quality of life
      in adults with ADHD, from psychiatric outpatient clinics (N=100) as well as from a
      high-security prison facility (N=50).
    

Detailed description: 
      The primary aim is to evaluate whether 5 weeks of computerised working memory training
      improves working memory capacity. Secondary aims are to explore whether improvements in
      working memory capacity will be transferred to improvements in learning abilities and fluid
      intelligence. Also, far transfer effects on executive functioning, ADHD symptoms,
      psychosocial functioning and quality of life will be explored. Finally, it will also be
      assessed to what extent improvements gained from 5 weeks of working memory training will be
      maintained 3 and 6 months post-study, respectively.
    

Intervention name(s): Flex working memory training
Intervention type(s): Behavioral
Intervention description(s): 30-40 minutes of working memory training, 5 days a week for 5 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: adhd; adults; working memory; training; RCT
How to Treat Opiate Withdrawal in Neonates
Condition: Neonatal Abstinence Syndrome
MeSH terms: Neonatal Abstinence Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Three different drugs are used in a randomised, double blind, clinical multi-centre trial
      with three arms. Major objective is to investigate the duration of drug treatment based on
      the Finnegan score. Secondary objectives are to document weight gain, the need for adding a
      second drug when the first drug is not effective enough and possible side effects such as
      convulsions.
    

Detailed description: 
      Background: Neonatal narcotic abstinence syndrome is an important medical, social and
      financial problem. Several drugs are used to treat the withdrawal symptoms in neonates that
      have been exposed to opiates in utero, but there is no consensus which one is best.

      Goal: Three different drugs are used in a randomised, double blind, clinical multi-centre
      trial with three arms. Major objective is to investigate the duration of drug treatment based
      on the Finnegan score. Secondary objectives are to document weight gain, the need for adding
      a second drug when the first drug is not effective enough and possible side effects such as
      convulsions.

      Methods: Neonates born after 34 completed weeks of gestation with meconium proven antenatal
      opiate exposure and parental informed consent are included. Infants with severe malformation
      are excluded. Each infant is assessed every eight hour by a modified Finnegan score. When 9
      points are exceeded drug treatment is started and dose increased stepwise according to the
      score. The masqued solution applied orally contains morphine, phenobarbital or
      chlorpromazine. When the maximum dose does not reduce the score, a second randomisation and
      one of the two remaining drugs is added, again in a blinded way.

      A total of 120 infants, 40 in each group will be included in the study.
    

Intervention name(s): Phenobarbital; Chlorpromazine; Morphine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Phenobarbital per os; Chlorpromazine per os; Morphine per os
Other intervention name(s): Phenobarbitone; Largactil; tinctura opii
Intervention MeSH terms: Morphine; Phenobarbital; Chlorpromazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: opiate dependence; withdrawal; newborn
A Phase II Trial of Salvage Treatment With Gemcitabine and S-1 Combination in Patients With Heavily Treated Advanced Colorectal Cancer.
Condition: Advanced Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the efficacy and safety of salvage tratment with Gemcitabine and S-1 Combination in
      metastatic colorectal cancer
    


Intervention name(s): Gemcitabine/S-1
Intervention type(s): Drug
Intervention MeSH terms: Gemcitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: colorectal cancer; gemcitabine; S-1
Baricitinib Therapy in COVID-19
Condition: COVID; Pneumonia
MeSH terms: COVID-19; Pneumonia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Retrospective study on the efficacy of baricitinib in 12 COVID-19 patients with moderate
      pneumonia.
    

Detailed description: 
      Baricitinib, an anti-Janus kinase inhibitor (anti-JAK) acting against JAK1 and JAK2 that
      inhibits JAK1- and JAK2-mediated cytokine release, was recently described using
      BenevolentAI's proprietary artificial intelligence-derived knowledge graph, as an agent that
      reduces the endocytosis into target cells, and to inhibit the entry. Based on its potential
      action on inhibition of SARS-CoV-2 entry, and on its known effects on reduction of cytokine
      release, baricitinib therapy was proposed in patients with moderate pneumonia to explore: the
      safety of this drug combined with antiviral (lopinavir-ritonavir) in COVID-19; as second
      outcome, to evaluate the impact of baricitinib in terms of clinical, laboratory, respiratory
      parameters, and reduction of ICU admission.

      Baricitinib was combined with antivirals because it does not interact with them due to its
      prevalent renal elimination.
    

Intervention name(s): Baricitinib 4 MG Oral Tablet
Intervention type(s): Drug
Intervention description(s): Baricitinib+antiviral therapy administration for 2 weeks
Other intervention name(s): Lopinavir/Ritonavir tablets 250 mg/bid
Intervention MeSH terms: Ritonavir; Lopinavir
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Baricitinib treated patients compared with controls (previously COVID-19 receving standard therapy)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID-19; BARICITINIB; MODERATE DISEASE
Comparison of Early Whole Body Vibration and Progressive Resistance Training in Fast-Track Total Knee Arthroplasty.
Condition: Knee Arthropathy
MeSH terms: Joint Diseases
Study type: Interventional

Summary: 
      Patients who have undergone total knee arthroplasty (TKA) with Fast-Track recovery protocol
      at the Department of Orthopedics and Traumatology at the Local University Hospital and meet
      the inclusion and exclusion criteria will constitute the study sample. The patients will be
      divided into 2 groups using the computerized randomization method in the post-operative 4th
      week; Whole Body Vibration Group and Progressive Resistance Exercise Group. The first
      evaluation of the participants will be made at the end of the post-operative 4th week. Final
      evaluations will be made at the end of the post-operative 10th week, following the 6-week
      training.
    

Detailed description: 
      Patients who have undergone total knee arthroplasty (TKA) with Fast-Track recovery protocol
      at the Department of Orthopedics and Traumatology at the Local University Hospital and meet
      the inclusion and exclusion criteria will constitute the study sample. The patients will be
      divided into 2 groups using the computerized randomization method in the post-operative 4th
      week; Whole Body Vibration Group and Progressive Resistance Exercise Group. The first
      evaluation of the participants will be made at the end of the post-operative 4th week. After
      2 days and 6 weeks of training a week, final evaluations will be made at the end of the 10th
      postoperative week. Evaluations will include measures of impairment in body functions and
      structures, activity limitation measures, balance assessment, and quality of life
      assessments. Evaluations will be made by a blind researcher. The study will be started with a
      total of 28 patients, including 14 participants in both groups. The sample size was
      determined by performing a power analysis. The purpose of the study will be explained to the
      patients by the researcher and the patients who agree to participate in the planned study
      will be included in the study.
    

Intervention name(s): Total Knee Arthroplasty; Whole Body Vibration; Progressive Resistance Training
Intervention type(s): Procedure; Other; Other
Intervention description(s): The extremities of patients admitted to the operating room to be applied TKA will be determined using a safe surgical Fast-Track recovery protocol. Patients will be operated by the same surgical team using the same technique. Spinal anaesthesia or general anaesthesia will be applied to the patients according to the evaluations of the anesthesiologists.; Whole Body Vibration; Progressive Resistance Training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: fast-track surgery; whole body vibration; progressive resistance training; total knee arthroplasty; rehabilitation