bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Interleukin 6 Receptor Antagonists in SARS-CoV-2 Patients
Condition: Corona Virus Infection
MeSH terms: Coronavirus Infections
Study type: Observational

Summary: 
      1. Investigate the possible effects of interleukin-6 receptor antagonists such as
           tocilizumab and sarilumab on the levels of IL-6, inflammtory and anti-inflammtory
           markers and cytokines before and after treatment in critically ill corona virus
           disease-19 patients.

        2. Correlate between IL-6 levels with other inflammatory markers as ferritin and C-reactive
           protein.

        3. investigate the possible changes on the levels of other inflammatory, anti-inflammatory
           markers and cytokines such as IL-10 and IP-10, before and after treatment.
    

Detailed description: 
      An outbreak of a mutated respiratory virus that belongs to the Coronavirus family was
      reported in mid-December 2019, in Wuhan, China. The virus was named as severe acute
      respiratory syndrome coronavirus (SARS-CoV-2) and the disease was named as coronavirus
      disease-19 (COVID-19) by the WHO. The infection spread pandemically and by the end of October
      2021,the number of confirmed cases of COVID-19 reached 244,897,472, including 4,970,435
      deaths, reported by WHO. Viral genome was sequenced and published by public health
      information on 10th of January. COVID-19 uses the same cell entry receptor {Angiotensin
      converting enzyme II} (ACE2) as SARS-CoV . Recent studies have shown that IL-6 level
      increased in severe cases of COVID-19. IL-6 is one of the major pro-inflammatory factors that
      contribute to the formation of cytokine storm.Therefore, the IL-6 monoclonal antibody (mAb)
      directed COVID-19 therapy has been used in clinical trial in China. The main conclusion they
      reached was that the treatment with the IL-6 receptor antagonists ( tocilizumab (TCZ),
      sarilumab, sirukumab, olamkicept and levilimab) improved outcomes, including survival. TCZ is
      a humanized antibody that blocks both soluble and membrane-bound forms of IL-6 receptor.
      Sarilumab is a fully human antibody against the IL-6 receptor that binds to both soluble and
      membrane-bound IL-6 receptors and has the approval of the food and drug administration (FDA)
      for rheumatoid arthritis (RA) treatment. Additionally, these drugs have been considered for
      off-label use in the treatment of COVID-19.
    

Intervention name(s): ELISA
Intervention type(s): Diagnostic Test
Intervention description(s): collection of blood samples from critically ill COVID-19 patients, then serum samples are collected after centrifugation measuring IL-6, IL-10 and IP-10 by ELISA
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        samples will be collected over a duration of one year
      
Biospecimen description: 
      serum samples of Corona virus disease-19 patients
    
Keywords: interleukin-6 receptor antagonists; Corona virus disease; sarilumab; interferon gamma inducible protein-10
Demonstrate Exubera Works As Well As Avandia When Added To Sulfonylurea + Metformin In Controlling Glucose
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      -  Whether a combination of three therapies - metformin and a sulfonylurea plus Exubera, an
           investigational drug, controls your diabetes at least as much as a triple combination
           therapy of metformin and a sulfonylurea plus Avandia, a Food and Drug Administration
           (FDA) approved drug.

        -  Whether a combination of two therapies - metformin plus Exubera controls your diabetes
           at least as much as a as a triple combination therapy of metformin and a sulfonylurea
           plus Avandia.
    


Intervention name(s): Inhaled insulin
Intervention type(s): Drug
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Hybrid Artificial Pancreas in Home Setting
Condition: Type 1 Diabetes Mellitus; Treatement by Insulin Pump
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is the evaluate an Artificial Pancreas during 2 months in
      home setting in Type 1 Diabetic patients
    

Detailed description: 
      During this study, we propose to assess an Artificial Pancreas in a group of Type 1 diabetic
      patients who will participate in two study periods of two-month duration with an insulin pump
      and a Continuous Glucose Monitoring (CGM) device. During one of these periods, called HYBRID
      Period, the patient will use the AP model when at home, from dinner to wake-up time whereas
      the patient will self manage glucose control with insulin pump and CGM for the rest of the
      day. During the control period called OPEN Period, patient self management of diabetes by
      insulin pump and CGM will be done at all times. Overall, an increase of time spent in range
      when using artificial pancreas in the hybrid period should be observed with a reduction of
      both hypo and hyperglycemia episodes.
    

Intervention name(s): HYBRID; OPEN
Intervention type(s): Device; Device
Intervention description(s): During the HYBRID Period, the patient will use the AP model when at home, from dinner to wake-up time whereas the patient will self manage glucose control with insulin pump and CGM for the rest of the day.; During the control period called OPEN Period, patient self management of diabetes by insulin pump and CGM will be done at all times.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 Diabetes,; T1DM,; Artificial Pancreas
Decitabine Combining Modified CAG Followed by HLA Haploidentical Peripheral Blood Mononuclear Cells Infusion for Elderly Patients With Acute Myeloid Leukemia(AML）
Condition: MDS; AML
MeSH terms: Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Demethylating agent decitabine enhances the immunogenicity of leukemia cells by inducing the
      expression of cancer testis antigens (CTAs),MHC class I and II molecules,costimulatory
      molecules and adhesion molecules. The leukemias cells treated by decitabine will become more
      sensitive to the following adoptive T cell therapy.
    


Intervention name(s): Decitabine; Cytarabine; aclacinomycin; Granulocyte colony-stimulating factor; HLA haploidentical mononuclear cells infusion
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): 20 mg/m²/day for 5 days
Other intervention name(s): G-CSF; DLI
Intervention MeSH terms: Cytarabine; Decitabine; Aclacinomycins; Lenograstim
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: demethylating agent; immunogenicity
Study to Evaluate an Implant With a Sloped Top in Patients With a Sloped Jaw Bone
Condition: Edentulism
Study type: Interventional

Summary: 
      The study aims to evaluate maintenance of lingual/palatinal marginal bone with the (ASTRA
      TECH Implant System) OsseoSpeed™ Profile implant in sites where the alveolar crest anatomy is
      sloped in a lingual to buccal direction.

      The hypothesis is that the sloped marginal contour of the implant will help preserve the
      lingual/palatinal marginal bone.
    


Intervention name(s): ASTRA TECH Implant System, OsseoSpeed™
Intervention type(s): Device
Intervention description(s): ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Long Term Safety of Tesofensine in Patients With Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      Purpose of the study is to evaluate the long term safety of tesofensine in obese patients
    


Intervention name(s): Tesofensine
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity
StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns
Condition: Skin Wound; Burns; Trauma-related Wound
MeSH terms: Wounds and Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      The proposed study is designed as a phase Ib open-label, dose-escalation, multicenter study
      evaluating the safety, tolerability, and efficacy of StrataGraft skin tissue in promoting the
      healing of the deep partial-thickness component of complex skin defects. The proposed study
      population will include patients with 3-49% Total Body Surface Area (TBSA) complex skin
      defects including a deep partial-thickness component resulting from thermal injury. The study
      has been designed to focus on the evaluation of safety and tolerability of prolonged exposure
      to increasing amounts of a single application of StrataGraft skin tissue, while also
      assessing the potential for StrataGraft tissue to promote healing of the deep
      partial-thickness component of these complex skin defects as an alternative to donor site
      harvesting and autografting. Targeted enrollment for this study is up to 30 patients with
      complex skin defects due to thermal burns which require surgical excision and autografting.
      Subjects will be sequentially enrolled in two cohorts of increasing treatment area receiving
      StrataGraft skin tissue that has been stored refrigerated prior to clinical use. A third
      cohort will receive StrataGraft skin tissue which has been stored cryopreserved and thawed in
      the operating room just prior to grafting.
    


Intervention name(s): StrataGraft Skin Tissue
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Inspiratory Muscle Training After Gastroplasty
Condition: Obesity
MeSH terms: Respiratory Aspiration; Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of post-operative inspiratory muscle
      training on muscle strength and endurance in patients with obesity submitted to gastroplasty.
    

Detailed description: 
      Gastroplasties, like other major abdominal surgeries, induce mechanical changes in the lungs
      and decreases of the respiratory muscle strength in the post-operative periods. Depending on
      the occurrence of pre-existing disturbs, obese patients may exhibit severe declines of
      respiratory function after these surgeries.

      Post-operative respiratory physiotherapy is a valuable intervention, involving a set of
      techniques aimed to expand pulmonary volumes and to improve arterial oxygenation, leading to
      decreases on the development of atelectasis and pneumonias. It induces faster recovery of
      respiratory function and reduction of lung complications, what may be particularly important
      in high-risk patients like over-weighted subjects.

      There are scanty data about the role of respiratory muscle training in the post-operative
      period. This is particularly true regarding inspiratory muscle training of obese patients
      submitted to gastroplasties.
    

Intervention name(s): inspiratory muscle training; control group
Intervention type(s): Device; Device
Intervention description(s): This daily respiratory exercise was performed from the 2nd day following surgery by using a linear pressure resistance device (Threshold ® IMT - Health Scan Products; USA)was initially set at 40% of the maximal inspiratory pressure, obtained in the 2nd post-operative day, being adjusted to every new maximal inspiratory pressure measurement.; In placebo muscular training the daily respiratory exercise was performed from the 2nd day following surgery by using a linear pressure resistance device (Threshold ® IMT - Health Scan Products; USA)no load until the 30th post-operative day.
Other intervention name(s): respiratory training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: obesity; gastroplasty; respiratory muscle training; muscle strength; physical therapy
IV Acetaminophen and Patent Ductus Arteriosus
Condition: Patent Ductus Arteriosus
MeSH terms: Ductus Arteriosus, Patent
Study type: Interventional

Summary: 
      This is a randomized controlled trial to evaluate the efficacy of IV acetaminophen versus IV
      ibuprofen in closing a hemodynamically significant patent ductus arteriosus in preterm
      infants.
    


Intervention name(s): Acetaminophen; Ibuprofen
Intervention type(s): Drug; Drug
Intervention description(s): infants receive acetaminophen for treatment of their PDA; infants receive ibuprofen, standard of care in our unit, for treatment of a PDA
Other intervention name(s): tylenol
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neonate; acetaminophen
Feasibility Study: Lifting and Tightening Neck Skin in Patients
Condition: Skin Laxity
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      Up to 30 subjects will be enrolled. All subjects will receive one Ultherapy treatment to the
      lower two thirds of the face and neck. Subjects will be equally grouped into those with a
      history of submentoplasty and or rhytidectomy and those naive to submentoplasty and or
      rhytidectomy. Follow-up visits will occur at 14, 30, 60, 90 and 180 days following treatment.
      Study images will be obtained pre-treatment, 30-60 minutes post-treatment, and at each
      follow-up visit.
    

Detailed description: 
      This is a prospective single center study. Subjects will be enrolled one per group as they
      present. Efficacy will be determined by the change in submental volume and cervicomental
      angle. GAIS and patient satisfaction questionnaires will also be obtained.
    

Intervention name(s): Ulthera System Treatment
Intervention type(s): Device
Intervention description(s): Focused ultrasound energy delivered below the surface of the skin
Other intervention name(s): Ultherapy™
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ulthera® System; Ultherapy™ Treatment; Ulthera, Inc.; Ultrasound treatment for skin tightening
Effects of tDCS Versus HD-tDCS for Stroke Rehabilitation
Condition: Chronic Aphasia
MeSH terms: Aphasia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the changes in language processing of patients with
      chronic aphasia after receiving non-invasive brain stimulation.Previous research using
      traditional transcranial direct current stimulation (tDCS) using 2 sponge electrodes has
      shown that persons with aphasia show more improvement after treatment when that treatment is
      accompanied by brain stimulation. Traditional tDCS has recently been modified to deliver
      current to more specific locations in the brain. This new delivery method is called
      high-definition tDCS (HD-tDCS). It is not known whether traditional tDCS (more diffuse
      current delivery) or HD-tDCS (more focal current delivery) will be the better approach for
      enhancing treatment outcomes. To answer this question, computerized speech-language treatment
      will be administered during the application of the different forms of brain stimulation.
    


Intervention name(s): HD-tDCS (Soterix); Transcranial Direct Current Stimulation (Neuroconn)
Intervention type(s): Device; Device
Intervention description(s): Subjects will be given individualized dose (number of electrodes and electrode placement) through High-Definition electrodes to target fMRI determined targets
Other intervention name(s): Soterix Medical High-Definition M x N stimulator; Soterix Medical HDTargets; Neuroconn
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Stroke; Anomia
A Trial of NOV-205 in Hepatitis C Patients Who Failed Standard Therapy
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to find out the effect of the investigational drug
      NOV-205 on the level of hepatitis C virus in the blood and whether NOV-205 is well-tolerated
      at different doses when taken by subjects with hepatitis C.
    


Intervention name(s): NOV-205
Intervention type(s): Drug
Intervention description(s): There will be 4 treatment Groups with 10 patients in each group:
Group A: 30 mg NOV-205 daily subcutaneous administration for 49 days
Group B: 30 mg NOV-205 daily subcutaneous administration for 98 days
Group C: 60 mg NOV-205 daily subcutaneous administration for 49 days
Group D: 60 mg NOV-205 daily subcutaneous administration for 98 days
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hepatitis C; chronic HCV; viral HCV; genotype 1; failed treatment with pegylated interferon plus ribavirin
Documentation of Humira in Psoriasis Patients in Routine Clinical Practice
Condition: Moderate to Severe Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Observational

Summary: 
      Safety and Effectiveness of adalimumab (Humira) in Psoriasis Patients in Routine Clinical
      Practice.
    

Detailed description: 
      Postmarketing Observational Study to Evaluate the Work Productivity, Safety and Efficacy of
      Humira for the Treatment of Moderate to Severe Plaque Psoriasis in Daily Clinical Practice.
      The primary objectives of the PMOS are to explore changes in health related care utilization
      data by the evaluation of:

        -  the number of missed working days

        -  the number of visits to doctor's office

        -  the number and duration of hospitalizations

        -  work ability to assess efficacy for different subgroups by

        -  the number of patients achieving a PASI 75 response to evaluate safety by

        -  the documentation and analysis of adverse events for all patients and subgroups with
           concomitant diseases Secondary objectives include the exploration of changes in quality
           of life measurements, of the influence of age, gender and duration of disease
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community Sample: Patients with Plaque Psoriasis
      
Keywords: Moderate to Severe Plaque Psoriasis; Humira; Safety; Efficacy; Work Productivity
Flap Sliding to Treat Post-LASIK Striae
Condition: LASIK Complication Management
Study type: Interventional

Summary: 
      This study assessed the efficacy and safety of a simple, noninvasive "flap sliding" technique
      for managing flap striae following laser in situ keratomileusis (LASIK). Included eyes
      underwent flap sliding 1-2 days after surgery, which involved using a cellulose sponge to
      gently slide the flap perpendicular to the striae. The flap was not lifted during the
      procedure. Thirteen of 14 eyes were successfully managed with flap sliding. Uncorrected
      distance visual acuity (DVA) improved in all patients 1 day after flap sliding, with 11 eyes
      having a corrected DVA of 20/25 or better. Complications following flap sliding occurred in 2
      eyes. We believe that our study makes a significant contribution to the literature because it
      demonstrates a simple, noninvasive technique for managing flap striae that develop during
      early post-LASIK epithelial healing.
    


Intervention name(s): Flap sliding
Intervention type(s): Procedure
Intervention description(s): All subjects underwent the "flap sliding" technique, which was performed at the Alforsan Eye Centre in Assiut, Egypt. Prior to surgery, all subjects underwent corneal imaging with anterior segment optical coherence tomography to confirm the presence of striae. All surgical procedures were performed by the same surgeon 1 or 2 days following LASIK.
Subjects were administered a topical anesthetic. Striae location and orientation were then determined after drying the corneal surface with a cellulose sponge. The sponge was used to push the LASIK flap over the stromal bed in a direction that was perpendicular to the striae. The flap was pushed from the proximal side of the striae toward the flap edge. The ultimate goal was to move striae and put the flap into its proper place. Following surgery, OCT imaging was repeated.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Effect of Food on the Pharmacokinetics of TAK-831 Tablet Formulation
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the pharmacokinetic (PK) of a single oral dose of
      TAK-831 400 milligram (mg) in the fasted state and to estimate the effect of food on the PK
      of a single oral dose of TAK-831 400 mg when administered as tablet formulation in healthy
      participants.
    

Detailed description: 
      The drug being tested in this study is called TAK-831. TAK-831 is being tested in healthy
      participants under fasting and fed conditions in order to determine the effect of food on the
      PK of single oral dose of TAK-831 tablet formulation. The study will enroll approximately 16
      participants. Participants will be randomly and equally assigned (by chance, like flipping a
      coin) to 1 of the 2 treatment sequences following as:

        -  TAK-831 400 mg Fasted + TAK-831 400 mg Fed

        -  TAK-831 400 mg Fed + TAK-831 400 mg Fasted All participants will be asked to take single
           oral dose of TAK-831 tablet at the same time on Day 1 of each Intervention Period. This
           single center trial will be conducted in the United States. The overall time to
           participate in this study is 23 days. Participants will visit the clinic on Day -1 and
           remained confined until Day 3 of Intervention Period 1 and 2. A washout period of
           minimum 7 days will be maintained between the doses in each Intervention Period.
           Participants will make 3 visits to the clinic on Days 4, 6 and 8 on each Intervention
           Period and will be contacted by telephone 14 days after the last dose of study drug (Day
           23) for a follow-up assessment.
    

Intervention name(s): TAK-831
Intervention type(s): Drug
Intervention description(s): TAK-831 film-coated tablet.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug therapy