bioihbjkbjnl/mcl2 huggingface dataset:
Intraartecular Platelet Rich Plasma for Sacroiliitis
Condition: Sacroiliitis
MeSH terms: Sacroiliitis
Study type: Interventional

Summary: 
      Comparison between the effect of steroids and platelet-rich plasma on low back pain after
      ultrasound-guided sacroiliac injection to determine any is more effective and of long
      duration
    

Detailed description: 
      A prospective randomized controlled study was conducted at the department of anesthesiology
      Mansoura University Hospital during the period from December 2017 to January 2019 on fifty
      ASA I-III adult patients, of both sex after approval of IRB (Institutional Review Board) ID
      number MS17.10.03 & IRB date 12-11-2017. The patients were randomly allocated into two groups
      each of 25 patients according to computer-generated random number codes that were placed in
      sealed envelopes, double blinded, with parallel-group comparison.

      Steroid Group (S) (n. 25):- Patients were injected by 4 ml of sterile water containing the
      methylprednisolone Acetate (Depo-Medrol) per-kg calculated dose (0.5mg/kg up to a lean muscle
      body weight of 80kg in the painful sacroiliac joint).

      Platelet rich plasma Group (P) (n. 25):-Patients received fixed volume of 4 ml platelet-rich
      plasma in the inflamed painful sacroiliac joint.
    

Intervention name(s): Ultrasound guided Sacroiliac intra-articular injection
Intervention type(s): Other
Intervention description(s): At the level of the sacral hiatus, the sacral cornuae were identified. posterior aspect of the sacroiliac joint, at 4.5 cm depth the SIJ was found. localal anesthetic was injected at the medial edge of the transducer, the spinal needle was advanced in a medial to lateral direction, under direct vision, until the needle was positioned in the SIJ. Local steroid solution or PRP 4ml volume was injected according to the study group and patient enrollment. If the injection is extra-articular, injectate (hyperechoic solution as it contains particulate steroid) can be seen spreading medially over the sacrum. The visual analog score, Oswestry Disability Index (ODI) score and the overall success rate basal, after one week,after one month,after three and six month's follow-up period after the initial block.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Platelet reach plasma; sacroiliac; Ultrasound; Steroid; Chronic low back Pain
PK-directed Dose Adjustment of IV Busulfan Conditioning Regimen for Autologous Stem Cell Transplant in Lymphoma Patients
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study for the outcome and safety of individualized busulfan dosing with
      cyclophosphamide and etoposide for patients preparing for a stem cell transplant to treat
      Non-Hodgkin or Hodgkin's Lymphoma.
    

Detailed description: 
      Evaluation of progression-free survival, transplant related mortality, overall survival, and
      overall response rate, in subjects with NHL and HL receiving an IV busulfan-based
      conditioning regimen with PK-guided IV busulfan dosing, followed by autologous HSCT as well
      as comparison to those receiving carmustine, etoposide, cytarabine, and melphalan (BEAM)
      conditioning regimen (and its variants) obtained from registry data in the Center for
      International Blood and Marrow Transplant Research (CIBMTR) Assessment of the safety profile
      of a BuCyE conditioning regimen with PK-directed dosing of IV busulfan will also be
      completed.
    

Intervention name(s): IV Busulfan, Cyclophosphamide and Etoposide (BuCyE Regimen)
Intervention type(s): Drug
Intervention description(s): Pk-directed IV Busulfan (based on test dose method) for 4 days followed by Etoposide 1400mg/m2 QD for one day and Cyclophosphamide 2.5 g/m2 QD for two days followed by autologous stem cell transplant.
Intervention MeSH terms: Cyclophosphamide; Busulfan; Etoposide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hodgkin Lymphoma; Non-Hodgkin's Lymphoma; Bone marrow transplant; stem cell transplant; busulfan; cyclophosphamide; etoposide
Diabetes in Neuropsychiatric Disorders
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study was to describe metabolic changes in the first 16 weeks of
      anti-psychotic treatment in previously drug-naïve patients with psychosis.

      We hypothesize that in drug-naive patients, greater insulin resistance prior to treatment
      predicts a disproportionately greater increase in insulin resistance with olanzapine
      treatment.
    

Detailed description: 
      Antipsychotic medications are associated with an increased risk of diabetes. We focused on a
      description of early metabolic adverse effects and clinical and biochemical features that
      might predict these adverse effects.
    

Intervention name(s): Olanzapine
Intervention type(s): Drug
Intervention description(s): 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge.
Other intervention name(s): Zyprexa, Zydis, Relprevv
Intervention MeSH terms: Olanzapine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Schizoaffective; psychosis; olanzapine
Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application
Condition: Hearing Loss
MeSH terms: Hearing Loss
Study type: Interventional

Summary: 
      A methodical evaluation of novel sound changing principles in CE-labelled Sonova brand
      hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing
      impaired. These sound changing principles are enabled by respective hearing instrument
      algorithms. The aim of the study is to investigate and asses strength and weaknesses of these
      novel sound changing principles in terms of hearing performance to determine their
      application in hearing instruments (Phase of development). Both, objective laboratory
      measurements as well as subjective evaluations in real life environment will be carried out.
      This will be a controlled, single blinded and randomized active comparator clinical
      evaluation which will be conducted mono-centric at Sonova AG Headquarter based in Staefa.
    


Intervention name(s): Phonak Audéo L2M with Sound Processing Principle 1; Phonak Audéo L2M with Sound Processing Principle 2; Phonak Audéo L2M with Sound Processing Principle 3
Intervention type(s): Device; Device; Device
Intervention description(s): Compensation of a hearing loss with Sound Processing Principle 1.; Compensation of a hearing loss with Sound Processing Principle 2.; Compensation of a hearing loss with Sound Processing Principle 3.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Each participant will be treated with sound principle 1, 2 and 3 in a crossover design.
Masking: Single (Participant)
Primary purpose: Treatment
Efficacy of Hyalase Hydro-dissection in Treatment of Carpal Tunnel: Randomized Double Blind Controlled Clinical Trial
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome
Study type: Interventional

Summary: 
      Carpal tunnel syndrome (CTS) is a common peripheral entrapment neuropathy, this study aims to
      investigate if, and to what extent hydro-dissection hyalase and saline of the median nerve
      could offer symptoms and clinical improvement
    

Detailed description: 
      Carpal tunnel syndrome (CTS) is the most common compression syndrome the upper extremities.
      Its problem has a high prevalence ranged estimated prevalence of 3.8% in the general
      population, 3 and 7.8% in the working population. It occurs at any age, especially in
      individuals in their 40s to 60s, and the male: female ratio is reported to be 3:7. A lot of
      treatment modalities have been tried to improve the condition, starting from local anesthetic
      injection, steroid, and up to surgical decompression of the nerves.
    

Intervention name(s): Hyalase; Saline
Intervention type(s): Drug; Drug
Intervention description(s): injection of Hyalase + 10 cc saline injection nearby median nerve as hydro-dissection; injection of 10 cc saline injection nearby median nerve as hydro-dissection
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Investigate if, and to what extent, hydro-dissection using Hyalase versus saline, under ultrasound guidance, can improve the clinical condition, change in nerve conduction parameters of patients with CTS and delay or avoid the surgical intervention.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Effects of ABO Blood Types on the Survival and Marginal Bone Resorption of Dental Implants
Condition: Implant Tissue Failure
MeSH terms: Bone Resorption
Study type: Observational

Summary: 
      This study evaluates implant survival and marginal bone resorption in patients receiving
      implant treatment with respect to demographic data and AB0 (groups) blood types.
    

Detailed description: 
      For a successful dental implant, optimal soft and hard tissue characteristics are required.
      These characteristics include appropriate bone quality and a healthy adherent keratinized
      gingiva that surrounds the implant neck. The most common complications are peri-implant
      diseases and marginal bone loss for dental implants. Marginal bone loss around the implant
      may be observed as a long-term complication due to microbial dental plaque-induced
      peri-implant inflammatory disease or may be observed in the absence of such a disease.

      The immune system and genetic factors are known to have important effects on implant success,
      and ABO blood types are also included in the genetic factors. In the studies evaluating the
      association of ABO blood types with increased susceptibility to infection and various
      systemic diseases, it was reported that the percentages of blood types differed
      significantly, especially in skeletal-muscle system injuries, fractures and cardiovascular
      disease susceptibility. Also some researchers reported that blood types may be effective on
      the bacteria colonization which is the main reason of the periodontal diseases. ABO blood
      types may have an impact on dental implant success and survival.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        This cross-sectional study was performed on patients who had undergone implant treatment
        and had prosthetic rehabilitation at the Faculty of Dentistry of the Van Yuzuncu Yil
        University between 2010 and 2017 and who had been followed up for at least one year.
      
Keywords: Blood types, Dental implant, Marginal Bone Resorption, Implant Survival
The Effect of Chronic Anemia on Safety Period of Tracheal Intubation in Gynecology Patients
Condition: Chronic Anemia
MeSH terms: Anemia
Study type: Interventional

Summary: 
      1. Every individual receiving a general anesthetic is at potential risk for developing a
           ''cannot intubate-cannot ventilate'' situation following anesthetic induction.

        2. Building up of oxygen reserves assumes great significance as this provides a longer
           duration of non-hypoxic apnea should one be faced with an unanticipated difficult
           airway.

        3. The main physiological functions of red blood cell hemoglobin are to deliver oxygen to
           the peripheral tissues.

        4. During anemia, a reduction in blood oxygen content occurs as a result of reduced Hb
           while arterial oxygenation and oxyhemoglobin saturation remain high.

        5. Previous studies about the duration of non-hypoxic apnoea focus on methods to improve
           the safety period of tracheal intubation.

        6. To our knowledge, there is no literature about the duration of non-hypoxic apnoea of
           anemia patients.

        7. The aim of this study was to assess the effect of chronic anemia on the duration of
           non-hypoxic apnoea during induction of anaesthesia.
    

Detailed description: 
      After breathing for 3 minutes, anesthesia induction was conducted. The endotracheal tube
      position was confirmed after anesthesia induction. Patients were left apneic with the
      endotracheal tube open to room air. The non-hypoxic apneic period was recorded as the time
      (in seconds) taken for the drop in pulse saturation to 90% or an apneic period of 10 min
      elapsed, whichever was earlier.
    

Intervention name(s): pre-oxygen
Intervention type(s): Biological
Intervention description(s): 3 min of preoxygenation before anesthesia induction.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: anemia; non-hypoxic apnoea; tracheal intubation; anesthesia
Bioequivalence Study of Sitagliptin/Metformin Combination Tablet (MK0431A-122)
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will test the hypothesis that the Final Market Image (FMI) sitagliptin/metformin
      50 mg/500 mg and 50 mg/850 mg (Fixed Dose Combination) FDC tablet and co-administration of
      corresponding doses of sitagliptin and China-sourced metformin as individual tablets will be
      bioequivalent based on assessment of the AUC(0-t) and Cmax, for both sitagliptin and
      metformin.
    


Intervention name(s): Co-administration of 50 mg sitagliptin and 500 mg metformin; sitagliptin/metformin 50 mg/500 mg tablet; Co-administration of 50 mg sitagliptin and 850 mg metformin; sitagliptin/metformin 50 mg/850 mg tablet
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Co-administration of 50 mg sitagliptin and 500 mg China-sourced metformin as individual tablets with 240 ml water on Day 1 of the relevant treatment period (Sit + Met500) after fasting for at least 10 hours.; Single dose administration of the final marketing image (FMI) sitagliptin/metformin 50 mg/500 mg fixed-dose combination (FDC) tablet with 240 ml water on Day 1 of the relevant treatment period (SitMet850 FDC) after fasting for at least 10 hours.; Co-administration of 50 mg sitagliptin and 850 mg China sourced metformin as individual tablets with 240 ml water on Day 1 of the relevant treatment period (Sit + Met850) after fasting for at least 10 hours.; Single dose administration of the FMI sitagliptin/metformin 50 mg/850 mg FDC tablet with 240 ml water on Day 1 of the relevant treatment period (SitMet850 FDC) after fasting for at least 10 hours.
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 Diabetes
An Extension Study to Assess Long-term Safety, Tolerability, and Efficacy of KarXT in Adult Patients With Schizophrenia (EMERGENT-4)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase 3, multicenter, 53-week, outpatient, open-label extension (OLE) study to
      evaluate the long-term safety, tolerability, and efficacy of KarXT in subjects with
      Diagnostic and Statistical Manual-Fifth Edition (DSM-5) schizophrenia who previously
      completed the treatment period of one of the two Phase 3 double-blind studies, KAR-007 or
      KAR-009. In this OLE study, all subjects will receive KarXT (a fixed combination of
      xanomeline 125 mg and trospium chloride 30 mg twice daily [BID]) for up to 52 weeks
      regardless of treatment assignment in the preceding Phase 3 acute study. The primary
      objective of the study is to assess the long-term safety and tolerability of KarXT in
      subjects with a DSM-5 diagnosis of schizophrenia. The secondary objective of this study is to
      assess the long-term efficacy and monitor trough concentrations of xanomeline and trospium
      after administration of KarXT.
    


Intervention name(s): Xanomeline and Trospium Chloride Capsules
Intervention type(s): Drug
Intervention description(s): Oral xanomeline 50 mg/trospium 20 mg BID on days 1-2 followed by xanomeline 100 mg/trospium 20 mg BID on days 3-7. The dose is increased to xanomeline 125 mg/trospium 30 mg BID on days 8-364 unless the subject is experiencing adverse events from the xanomeline 100 mg/ trospium 20 mg dose. Subjects who were increased to xanomeline 125 mg/trospium 30 mg will have the option to return to xanomeline 100 mg/ trospium 20 mg depending on clinical response and tolerability. Re-escalation to 125/30 BID or re-titration in cases in which the subject has been off KarXT for a longer period of time (at least a week) is allowed and will require a discussion between the principal investigator and the medical monitor.
Other intervention name(s): KarXT
Intervention MeSH terms: Xanomeline; Trospium chloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Metabolism and Pharmacokinetics of [14C]-BIBR 953 ZW After Administration of Single Doses of [14C]-BIBR 953 ZW Intravenously or [14C]-BIBR 1048 Oral Solution in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study were to investigate the metabolism and pharmacokinetics of BIBR 1048 MS
      and BIBR 953 ZW in man.
    


Intervention name(s): BIBR 953 ZW Intravenously; BIBR 1048 Oral Solution
Intervention type(s): Drug; Drug
Intervention description(s): 5 mg, 2.8 MBq (76 µCi); 200 mg free base, 2.8 MBq (76 µCi)
Intervention MeSH terms: Dabigatran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bone Marrow Transplantation in Treating Patients With Multiple Myeloma, Chronic Phase Chronic Myelogenous Leukemia, or Agnogenic Myeloid Metaplasia
Condition: Chronic Myeloproliferative Disorders; Leukemia; Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Leukemia; Multiple Myeloma; Neoplasms, Plasma Cell; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase; Plasmacytoma; Myeloproliferative Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Bone marrow transplantation may be able to replace immune cells that were
      destroyed by the chemotherapy or radiation therapy that was used to kill cancer cells.

      PURPOSE: Phase II trial to study the effectiveness of allogeneic bone marrow transplantation
      in treating patients who have multiple myeloma, chronic phase chronic myelogenous leukemia,
      or agnogenic myeloid metaplasia.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the efficacy of allogeneic bone marrow transplantation (BMT) following
           high-dose cyclophosphamide and total body irradiation in patients with multiple myeloma,
           agnogenic myeloid metaplasia, or chronic myelogenous leukemia in first or second chronic
           phase.

        -  Determine the efficacy of BMT following busulfan and cyclophosphamide in these patients.

        -  Determine the toxic effects of these preparative regimens in these patients.

      OUTLINE: Patients are stratified by remission (first vs second vs third).

      Patients who have not undergone prior radiotherapy receive cyclophosphamide IV on days -6 and
      -5 and then undergo total body irradiation twice a day on days -4 to -1. Allogeneic bone
      marrow is infused on day 0.

      Patients who have undergone prior radiotherapy receive oral busulfan every 6 hours on days -7
      to -4 or -6 to -3 and cyclophosphamide IV over 2 hours on days -3 and -2. Allogeneic bone
      marrow is infused on day 0.

      Patients are followed at days 30 and 90, at 6 months, and then annually thereafter.

      PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 2 years.
    

Intervention name(s): busulfan; cyclophosphamide; allogeneic bone marrow transplantation; radiation therapy
Intervention type(s): Drug; Drug; Procedure; Radiation
Intervention MeSH terms: Cyclophosphamide; Busulfan
Primary purpose: Treatment
Keywords: refractory multiple myeloma; stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma; chronic phase chronic myelogenous leukemia; chronic idiopathic myelofibrosis; Philadelphia chromosome positive chronic myelogenous leukemia
Insertion Time Over Fiberoptic Bronchoscope of Double Lumen Tube and Single Lumen Tube
Condition: Intubation;Difficult
Study type: Interventional

Summary: 
      One lung ventilation (OLV) is required during thoracic procedures such as lung and esophagus
      surgery. three technique can be employed. (1) placement of a double-lumen bronchial tube
      (DLT); (2) use of a single-lumen tracheal tube (SLT) in conjunction with a bronchial blocker;
      (3) insertion of a conventional SLT into a main bronchus. Flexible fiberoptic intubation with
      SLT is well established technique for anticipated or unexpected difficult intubation. But,
      little is known about flexible fiberoptic intubation with DLT.

      The investigators compared insertion time over fiberoptic bronchoscope between SLT with
      bronchial blocker and DLT in patients undergoing thoracic surgery.
    


Intervention name(s): single lumen tube and bronchial blocker; double lumen tube
Intervention type(s): Device; Device
Intervention description(s): fiberoptic intubation with single lumen tube and bronchial blocker; fiberoptic intubation with double umen tube
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Device Feasibility
Keywords: Fiberoptic intubation; double lumen tube
Study of Efficacy of Levofloxacin 0.5% Ophthalmic Solution Administered Three Times a Day for Bacterial Conjunctivitis
Condition: Bacterial Conjunctivitis
MeSH terms: Conjunctivitis, Bacterial; Conjunctivitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of the study is to evaluate the clinical and microbiological efficacies of three
      times daily administration of levofloxacin 0,5% eye drops as compared to the more frequent
      dosing (up to 8 times a day during the first 2 days and up to 4 times a day during the next 3
      days) in patients with bacterial conjunctivitis.
    


Intervention name(s): 0.5% levofloxacin eye drops; 0.5% levofloxacin eye drops
Intervention type(s): Drug; Drug
Intervention description(s): 0.5% levofloxacin eye drops three times daily to each eye for 5 days; 0.5% levofloxacin eye drops 2 hours on days 1 and 2, and then every 4 hours on days 3-5 (up to 4 times per day)
Intervention MeSH terms: Levofloxacin; Ofloxacin; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: bacterial conjunctivitis levofloxacin fluoroquinolone