bioihbjkbjnl/mcl2 huggingface dataset:
Is The Sudden Onset of Dizziness A Symptom of Acute Liver Dysfunction?
Condition: Dizziness
MeSH terms: Liver Diseases; Vertigo; Dizziness
Study type: Observational [Patient Registry]

Summary: 
      Dizziness is one of the most common complaints among patients admitted to the emergency
      department (ED). In most cases, the etiology remains unclear. Dizziness has a broad
      differential diagnosis. The initial symptoms of ALD can include many general complaints. Aim
      of this study is to investigate whether SOD is a symptom of ALD, the necessity of liver
      function tests for patients with SOD in the ED, and a cost analysis of liver function tests.
    

Detailed description: 
      Dizziness is one of the most common complaints among patients admitted to the emergency
      department (ED). In most cases, the etiology remains unclear. Dizziness has a broad
      differential diagnosis. The initial symptoms of ALD can include many general complaints. The
      diagnosis of acute liver dysfunction (ALD) can usually be made by initial symptoms, physical
      examination, and biochemical tests, including liver function tests (LFTs) with high
      sensitivity and specificity. LFTs include albumin, bilirubin, coagulation factors (Activated
      Partial Thromboplastin Time (aPTT) and International Normalized Ratio (INR)), and liver
      enzymes, such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline
      phosphates (ALP), and y-glutamyl transpeptidase (GGT), which are marker of hepatic damage.
      Aim of this study is to investigate whether SOD is a symptom of ALD, the necessity of LFTs
      for patients with SOD in the ED, and a cost analysis of LFTs.
    

Intervention name(s): LFTs
Intervention type(s): Other
Intervention description(s): A single 5-ml peripheral venous blood sample was collected from each participant.
Serum ALT, AST, ALP, GGT, total bilirubin, conjugated bilirubin, and albumin level, Platelet count, INR and aPTT were analyzed.
Other intervention name(s): liver function tests
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult patients with sudden onset dizziness admitted to emergency department.
Transfusion and Skeletal Muscle Tissue Oxygenation
Condition: Anemia
Study type: Observational

Summary: 
      The aim of the present study was to re-challenge the current data that anaemia in chronically
      anaemic haematology patients is not associated with low skeletal muscle StO2, and that the
      age of RBCs does not influence tissue responses. The investigators investigated these aspects
      using improved technology NIRS devices, for deeper tissue penetration and removal of the
      superficial signal from the skin.
    

Detailed description: 
      Anaemia is state of decreased blood oxygen carrying capacity . Acute anaemia is associated
      with increased tissue oxygen extraction . On the other hand, with chronic anaemia human body
      has time to at least partially adapt to decreased blood oxygen carrying capacity , .

      Near-infrared spectroscopy (NIRS) is non-invasive method to assess tissue oxygenation (StO2)
      and estimate tissue haemoglobin (THb) levels . The investigators have studied skeletal muscle
      StO2 in critically ill patients with preserved oxygen (i.e., cardiogenic shock) and with
      impaired oxygen extraction (i.e., septic shock) , , . In addition to measuring resting StO2,
      the investigators performed vascular occlusion tests to stop arterial blood flow, to estimate
      oxygen consumption, and at the end of the occlusion, it was also possible to estimate
      vascular reactivity and maximal reperfusion capability .

      Under acute blood loss in trauma patients, the skeletal muscle StO2 measured by NIRS
      correlates with blood haemoglobin (Hb) and delivery of oxygen, and can easily detect latent
      stage of haemorrhagic shock . Unexpectedly, chronically anaemic haematology patients with
      preserved oxygen extraction capability did not show low skeletal StO2 and THb index despite
      their severe anaemia, which is what would be predicted from normal physiological responses .

      It is known that there are structural and functional changes to RBCs during storage. Recent
      study detected deleterious effects of RBC storage on microvascular responses to transfusion
      in stable anaemic trauma patients .

      The aim of the present study was to re-challenge the current data that anaemia in chronically
      anaemic haematology patients is not associated with low skeletal muscle StO2, and that the
      age of RBCs does not influence tissue responses. The investigators investigated these aspects
      using improved technology NIRS devices, for deeper tissue penetration and removal of the
      superficial signal from the skin.
    

Intervention name(s): NIRS
Intervention type(s): Other
Intervention description(s): Measurment of skeletal muscle oxygenation by near-infrared spectroscopy
Other intervention name(s): near infrared spectroscopy
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Hematologic anaemic patients
      
Keywords: NIRS; transfusion; RBC
A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to achieve approval for the use of carbidopa/levodopa/entacapone
      in early Parkinson's disease (PD) by demonstrating that when used as initial levodopa therapy
      in early PD, carbidopa/levodopa/entacapone provides significantly greater symptomatic benefit
      than immediate release carbidopa/levodopa administered at the same levodopa dosage level of
      100 mg three times a day (t.i.d.).
    

Detailed description: 
      The purpose of this study is to achieve approval for the use of carbidopa/levodopa/entacapone
      in early Parkinson's disease (PD) by demonstrating that when used as initial levodopa therapy
      in early PD, carbidopa/levodopa/entacapone provides significantly greater symptomatic benefit
      than immediate release carbidopa/levodopa administered at the same levodopa dosage level 100
      mg t.i.d.
    

Intervention name(s): capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)
Intervention type(s): Drug
Other intervention name(s): Stalevo; CELC200
Intervention MeSH terms: Levodopa; Carbidopa; Entacapone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's disease, levodopa, dyskinesia
Comparison of Three Plasmodium Falciparum Isolates in a Controlled Human Malaria Infection
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional

Summary: 
      An effective vaccine against malaria is urgently needed to combat the scourge of this
      disease. Before candidate vaccines can be tested in endemic countries, they are first tested
      in human volunteers in so-called Controlled Human Malaria Infections (CHMI's). Ideally, a
      candidate vaccine should be tested against multiple strains of malaria, representative of the
      disease's global distribution. To date, however, only one such strain (NF54) has been broadly
      used in CHMI's.

      The purpose of this study is to compare the course of infections with 2 novel malaria strains
      to those with NF54 in human volunteers.
    

Detailed description: 
      Plasmodium falciparum (Pf) malaria remains responsible for an intolerable burden of morbidity
      worldwide and an effective vaccine is sorely needed to aid control efforts. Before candidate
      malaria vaccines can enter full-scale (phase IIb) field trials in endemic areas, they must
      first be tested under controlled circumstances in (phase IIa) clinical human malaria
      infection studies. Since Pf isolates display a wide genetic diversity across the globe, phase
      IIa challenge infections should be conducted with both homologous and heterologous strains.

      Since 1998 a highly successful Controlled Human Malaria Infection model at the UMC St
      Radboud, Nijmegen, The Netherlands, has been employed both to test candidate vaccines and to
      answer fundamental questions about pathophysiological and immunological mechanisms during
      early Pf infection in human volunteers. To date largely the NF54 strain of P. falciparum has
      been used in this Nijmegen model, with which extensive experience has meanwhile been
      acquired. In order to increase the portfolio of Pf strains available for future phase IIa
      studies, it is first necessary to document in detail the parasitological, clinical and
      immunological characteristics of new candidate strains during a controlled human malaria
      infection. In this study, the strains NF135 and NF166 will be compared in this regard with
      the well-characterised NF54 strain.
    

Intervention name(s): NF54; NF135; NF166
Intervention type(s): Other; Other; Other
Intervention description(s): Volunteers will be infected with the NF54 strain of Plasmodium falciparum through the bites of 5 infected Anopheline mosquitoes.; Volunteers will be infected with the NF135 strain of Plasmodium falciparum through the bites of 5 infected Anopheline mosquitoes.; Volunteers will be infected with the NF166 strain of Plasmodium falciparum through the bites of 5 infected Anopheline mosquitoes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Plasmodium falciparum; malaria
Vitamin D Supplement Study for Adolescents
Condition: Vitamin D Deficiency; Overweight; Obesity
MeSH terms: Overweight; Vitamin D Deficiency
Study type: Interventional

Summary: 
      The purpose of this study is to determine if 14-19 year old African American adolescents are
      able to take a daily vitamin D supplement daily for about 4 months and how well a daily dose
      of 400 IU or 2000 IU vitamin D supplement raises their vitamin D blood level.
    

Detailed description: 
      To determine the feasibility of African American teenagers taking a daily vitamin D
      supplement over a 4 month period in terms of compliance and practical implementation.

      To determine the differences in response in blood 25-OH D level between those randomly
      assigned to taking a 400 IU supplement versus 2000 IU per day and to determine if there are
      differences in blood 25-OH D level response depending on subject gender and overweight/obese
      versus healthy-weight status.
    

Intervention name(s): 2000 IU Vitamin D3 daily supplement; 400 IU Vitamin D3 supplement
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2000 IU vitamin D3 supplement to be taken once daily over 4 months; 400 IU Vitamin D3 supplement to be taken daily over 4 months
Other intervention name(s): NatureMade Maximum Strength D Vitamin 2000 IU List NO. 2516; NatureMade D Vitamin 400 IU List No. 1688
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Vitamin D deficiency; Adolescents; African Americans; Overweight; Obesity
Fibromyalgia Syndrome on Patients With Chronic Migraine
Condition: Chronic Migraine, Headache; Fibromyalgia Syndrome; Chronic Pain Syndrome; Central Sensitisation; Headache Disorders
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Migraine Disorders; Headache Disorders; Syndrome; Chronic Pain; Headache
Study type: Interventional

Summary: 
      The aim of this study to evaluate the effects of fibromyalgia syndrome accompanying women
      with chronic migraine on pain, quality of life, sleep, anxiety and depression, central
      sensitization and functionality.
    

Detailed description: 
      Patients who applied to Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine,
      Department of Neurology, headache outpatient clinic and were diagnosed with chronic migraine
      according to the International Headache Society Classification (ICHD-3), after the patient's
      history and physical examination, will be included in the study.

      Date of birth, education level, body mass index, occupation, marital status, socioeconomic
      status, age of onset of migraine complaints, descriptive information about migraine attacks
      (type (with or without aura), duration of attacks, average number of days with pain, pain
      severity, accompaniments) will be questioned.

      In addition, if the fibromyalgia syndrome meets the diagnostic criteria, symptom duration and
      average body pain severity in the last 3 months will be questioned.

      A total of 66 patients are planned to be included in the study. In the study, 2 groups will
      be formed, the first group will consist of chronic migraine patients, the second group will
      consist of patients with chronic migraine as well as fibromyalgia syndrome.

      All patients will be evaluated for allodynia, quality of life, sleep, anxiety and depression,
      disability related to headache, and central sensitization. Relevant forms will be filled by
      patients.

      Patients will be evaluated with the diagnostic criteria for fibromyalgia syndrome and if the
      patients meet the diagnostic criteria for fibromyalgia syndrome, the Fibromyalgia Impact
      Questionnaire will be applied. The patient will be evaluated by Alper Mengi in terms of
      fibromyalgia syndrome diagnostic criteria.
    

Intervention name(s): Allodynia, quality of life, sleep, anxiety and depression, disability, and central sensitization; Fibromyalgia syndrome
Intervention type(s): Other; Other
Intervention description(s): All patients will be evaluated for allodynia, quality of life, sleep, anxiety and depression, disability related to headache, and central sensitization.; Patients who meet the diagnostic criteria for fibromyalgia syndrome will be evaluated with the Fibromyalgia Impact Questionnaire.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Mannitol Improves Cerebral Oxygen Saturation
Condition: Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      Decreased cerebral oxygen saturation (rSO2) was reported to occur during insufflation for
      laparoscopic procedures due to increased Intracranial pressure (ICP) with resultant decrease
      in cerebral perfusion pressure.
    

Detailed description: 
      Forty patients scheduled for laparoscopic cholecystectomy will be enrolled in this double
      blind, randomized controlled study. Patients will receive either 0.5g/kg of 20% intravenous
      (i.v.) mannitol infusion over 10 minutes immediately before induction of anesthesia (group M)
      or an equal volume of 0.9% normal saline instead (group C). Primary outcome measure is rSO2.
      Secondary outcome variables include extubation time, clinical assessment of consciousness
      recovery using the modified Observer's assessment of alertness/sedation scale (OAA/S) and the
      mini-mental state examination (MMSE) for cognitive evaluation after recovery.
    

Intervention name(s): Mannitol; Control
Intervention type(s): Drug; Drug
Intervention description(s): 0.5g/kg of 20% intravenous (i.v.) mannitol infusion over 10 minutes immediately before induction of anesthesia; Saline infusion
Other intervention name(s): mannite or manna sugar; Saline
Intervention MeSH terms: Mannitol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anesthesia; Recovery; laparoscopy; cholecystectomy
Rainbow Extension Study
Condition: Retinopathy of Prematurity (ROP)
MeSH terms: Retinal Diseases; Retinopathy of Prematurity; Premature Birth
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to evaluate the long term efficacy and safety of intravitreal
      ranibizumab compared with laser ablation therapy in patients who were treated for retinopathy
      of prematurity (ROP) in the core study CRFB002H2301 (NCT02375971)
    

Detailed description: 
      This was a multicenter, open-label extension study where the Visual Acuity (VA) assessment at
      the child's 5th birthday visit was performed. The study had 2 distinct periods (Epochs).
      Treatment with study ranibizumab (either as retreatment after ranibizumab had already been
      injected in the same eye or as switch ranibizumab treatment from study laser therapy
      administered in the core study) was permitted for eligible eyes with recurrence/worsening of
      ROP up to and including Week 40 from the baseline visit in the core study (Epoch 1). The
      remainder of the extension study up to the 5th birthday visit (Epoch 2) was observational,
      with no study treatment planned to be administered.

      In the core study, patients were randomized to 1 of the 3 treatment arms (ranibizumab 0.2 mg,
      ranibizumab 0.1 mg, and laser). Treatment arm assignment and patient identifier in the
      extension study remained the same as in the core study.
    

Intervention name(s): Ranibizumab
Intervention type(s): Drug
Intervention description(s): 1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required
Intervention MeSH terms: Ranibizumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: open-label,; long-term,; extension study,; intravitreal ranibizumab,; laser ablation therapy,; retinopathy of prematurity,; preterm infants,; RAINBOW
First in Man Study of Safety, Tolerability and PK Profile of RBP-7000
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability and PK profile of a single
      dose of 60mg RBO-7000 in stable subjects with schizophrenia who are on medication other than
      risperidone.
    

Detailed description: 
      Twelve subjects with stable schizophrenia will be enrolled. The expected duration of
      participation is 88 days which includes at least a 2 days screening and an 85 day treatment
      period (15 -day inpatient stay in the clinical unit and an additional 70-day outpatient
      period, including the Day 85 end of study follow up or early termination visit. Visits will
      occur approximately weekly during the outpatient period.

      Neurological and clinical symptom assessments (Positive and Negative Syndrome Scale [PANSS],
      Clinical Global Impressions-Schizophrenic Specific [CGI-SCH], Simpson-Angus Scale [SAS],
      Barnes Akathisia Scale [BAS], and Columbia-Suicide Severity Rating Scale [C-SSRS]) will be
      conducted at screening, on the day of admission to the clinical unit (Day -1), and at each
      post-dose visit throughout the study including the follow-up visit. Scale results will be
      reviewed by the Principal Investigator. The Abnormal Involuntary Movement Scale (AIMS) for
      Tardive Dyskinesia will be performed at screening and at each post-dose visit throughout the
      study including the end of study follow-up visit. CYP-2D6 genotyping will be conducted at
      screening. Tolerability will be measured using SAS, which will be conducted as described
      above.

      Blood samples to assess the PK parameters will be taken from pre-dose until approximately 84
      days post-dose.

      End of study procedures will be conducted on follow-up Day 85 (84 days post-dose) or early
      termination (ET) to assess any adverse events (AEs) that were ongoing at the last visit, any
      new AEs that have developed, and for measurement of safety parameters.
    

Intervention name(s): RBP-7000
Intervention type(s): Drug
Intervention description(s): Single dose
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Wearable Vibration Therapy on Shoulder Functionality in Individuals Receiving Adjuvant Radiotherapy After Breast Cancer Surgery
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The aim of our study is to investigate the effect of vibration therapy to be applied to
      patients undergoing breast cancer surgery and adjuvant radiotherapy on upper extremity joint
      range of motion, muscle strength, grip strength, pain, functionality, and quality of life.
    


Intervention name(s): MYOVOLT (MyovoltTM, Myovolt Limited, Christchurch, New Zealand ) wearable vibration therapy device; Home based exercise
Intervention type(s): Device; Other
Intervention description(s): Patients will wear Myovolt shoulder device twice a week and each session will continue 30minutes. This therapy will apply during the radiotherapy process. The device will be applied on the bare skin of the shoulder area. The first 10 minutes of the 30 minutes will be intermittent vibration, the other 20 minutes will be done in the sinusoidal vibration program. Both programs will be in the range of 20-100 Hz.; Patients will do home based exercise during the radiotherapy process. 5 days a week. 2 sessions a day, each exercise will be 10x2 repetitions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care