bioihbjkbjnl/mcl2 huggingface dataset:
Autologous Bone Marrow Cell Transplantation in Persons With Acute Spinal Cord Injury- An Indian Pilot Study.
Condition: Acute Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Pilot study on 7 subjects in each group (total 21 subjects) to establish the safety and
      feasibility of autologous bone marrow cell transplantation in case of acute complete spinal
      cord injury by each of the following techniques and a corresponding number of controlled
      subjects:

        -  Directly into the injured site with a syringe after exposing the spinal cord.

        -  By Intrathecal injection.
    

Detailed description: 
      Intervention : Autologous bone marrow cell: Transplantation of the autologous bone marrow
      cell transplantation through one of the below mentioned techniques: 1. Directly into the
      injured spinal cord site with a syringe after exposing the spinal cord. 2. By Intrathecal
      injection. Number of cells Injected: 200 million cells in 1.8 ml of autologous plasma. In
      case of Direct delivery, the cells were delivered in one sitting at six sites ( 2 above the
      lesion, 2 at the lesion and 2 below the lesion) as 0.3 ml aliquots each. In case of
      Intrathecal injection, the cells were delivered as a single injection of 1.8ml via lumbar
      puncture. Frequency of Injection: Single Total duration of Therapy: The procedure of Bone
      marrow harvesting, enrichment and transplantation was completed in a single setting of
      approximately 2-3 hours. The transplantation procedure in case of Direct delivery took 2 mins
      per injection site that is approximately 12 mins and in case of lumbar puncture the
      transplantation procedure took approximately 2 mins.

      Comparator Agent:Control: control subjects with acute complete spinal cord injury who would
      not receive any bone marrow transplantation.
    

Intervention name(s): autologous bone marrow cell
Intervention type(s): Biological
Intervention description(s): Transplantation of 200 million cells in 1.8 ml of autologous plasma in a single sitting. In case of intralesional route, the cells were delivered in one sitting at six sites ( 2 above the lesion, 2 at the lesion and 2 below the lesion) as 0.3 ml aliquots each. In case of Intrathecal route, the cells were delivered as a single injection of 1.8ml via lumbar puncture.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Long-term Treatment Study of Certolizumab Pegol Without Coadministration of Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      The objectives of this study are to evaluate the safety and efficacy of certolizumab pegol
      when administered without coadministration of methotrexate over the long term in Japanese RA
      patients who transferred from Study 275-08-003 (NCT00791921), and to evaluate the effects of
      different dosing regimens on the safety and efficacy of certolizumab pegol in American
      College of Rheumatology 20% (ACR20) responders who completed Study 275-08-003.
    

Detailed description: 
      This study was initiated by Otsuka Pharmaceutical Co., Ltd and transferred to Astellas on
      12/04/2012.
    

Intervention name(s): Certolizumab pegol
Intervention type(s): Drug
Intervention description(s): Subcutaneous (SC) injection
Other intervention name(s): Cimzia; CDP870
Intervention MeSH terms: Certolizumab Pegol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; Certolizumab Pegol; Cimzia
Bay1002670, Fibroids, Safety and Efficacy EU,US,Can, Jap
Condition: Leiomyoma
MeSH terms: Leiomyoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is performed to assess the efficacy and safety of different doses of BAY1002670 in
      subjects with uterine fibroids. The dose-response relationship will be evaluated. Further,
      the study aims to establish a population pharmacokinetic/pharmacodynamic relationship for
      BAY1002670 in subjects with uterine fibroids. To assess the efficacy of BAY1002670 the
      interchangeability of menstrual pictogram and alkaline hematin method for the judgement of
      menstrual blood loss will be assessed.
    


Intervention name(s): BAY1002670; BAY1002670; BAY1002670; BAY1002670; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subjects received 4 milligram (mg) Vilaprisan (VPR) tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.; Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.; Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.; Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.; Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Uterine fibroids
Comparison of Postoperative Early Period Quality of Life of Patients With Open and Robot Assisted Kidney Transplantation
Condition: Quality of Life
Study type: Observational [Patient Registry]

Summary: 
      The investigators aimed to investigate the quality of life in patients with end-stage renal
      disease who underwent open or robot-assisted renal transplantation. Also, the investigators
      sought to determine the parameters which can affect the quality of life in these patients
    

Detailed description: 
      Patients who underwent open or robot-assisted renal transplantation at Bakirkoy Sadi Konuk
      Training and Research Hospital between June 2016 and December 2018 constituted the target
      population of this study. After application of the inclusion and exclusion criteria, the
      patient group was divided into two groups as per the surgical technique (i.e., open vs.
      robot-assisted). Demographic data, preoperative and postoperative data of all patients were
      collected prospectively. The quality of life of the patients was assessed preoperatively and
      on the postoperative 30th day
    

Intervention name(s): Renal transplantation
Intervention type(s): Procedure
Intervention description(s): Open or robot assisted renal transplantation
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who were performed open or robot assisted renal transplantation due to End Stage
        Renal Disease
      
Keywords: End Stage Renal Disease; Renal Transplantation; Quality of Life
Drug-drug Interaction Study of CTP-543 and Itraconazole in Healthy Adult Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 open-label study of the effect of itraconazole on the pharmacokinetics of
      CTP-543 in healthy subjects.
    


Intervention name(s): CTP-543
Intervention type(s): Drug
Intervention description(s): Itraconazole in solution dosage form
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Itraconazole; Drug-drug interaction; CTP-543
MRI and Ultrasound Findings in Patients With Gout and Normal Plain Radiographs
Condition: Gout
MeSH terms: Gout
Study type: Interventional

Summary: 
      Radiographic imaging plays a key role in managing the long-term effects of hyperuricemia on
      the skeletal system. Two of the accepted indications for prophylactic urate-lowering drugs in
      patients with hyperuricemia are gouty tophi and erosions. While much data exist on the plain
      radiographic changes that are seen in patients with chronic gout, far less is known about the
      changes seen on other imaging modalities, such as magnetic resonance imaging (MRI) and
      ultrasound (US). Further, there is very little data on the MRI and US appearance of
      asymptomatic joints in patients with hyperuricemia and symptomatic gout.

      There is vast emerging data to suggest that MRI and US are much more sensitive than plain
      radiographs at detecting the early stigmata of rheumatoid arthritis (RA). Indeed, these
      imaging devices have revolutionized the treatment of RA, for the earlier detection of the
      skeletal changes of RA often mandates more aggressive therapy. These same changes would often
      be missed by plain radiographs.

      It is our hypothesis that MR imaging and US will detect the skeletal changes that are typical
      of gout much sooner than would plain radiography. We also hypothesize that these same imaging
      techniques will be able to detect signs of hyperuricemic silent deposition in asymptomatic
      joints of patients with symptomatic gout in other joints. As was the case with RA, the
      expected results of this study would mandate more aggressive therapy of both gout and
      hyperuricemia.

      Our primary aim of this proposal would be accomplished by studying patients with known gout
      and normal plain radiographs. Each patient would have their most frequently involved joint
      (index joint) analyzed by MRI and US to evaluate for any destructive changes (erosions or
      tophi with cortical damage). Any signs that may portend future joint destruction such as
      synovial pannus, bone marrow edema, soft tissue edema, or joint effusions will also be
      documented. In order to demonstrate the effects of hyperuricemic silent deposition, an
      asymptomatic joint from these same patients will be studied using these same imaging
      techniques. Any evidence of erosions, tophi, synovial pannus, bone marrow or soft tissue
      edema, or joint effusions will be recorded. By demonstrating destructive, or potentially
      destructive, skeletal changes in the index joint or asymptomatic joint of a significant
      number of patients, we will show that patients who are left untreated on the basis of normal
      plain radiographs are likely to already have skeletal damage.
    


Intervention name(s): MRI and Ultrasound
Intervention type(s): Other
Intervention description(s): MRI and US of the joint
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Comparison of NPH Insulin and Insulin Detemir in Children and Adolescents With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Europe.

      The aim of this research is to compare the efficacy and safety of treatment with NPH insulin
      and insulin detemir. You will be treated with either insulin detemir or NPH insulin once or
      twice daily as basal insulin. Additionally you will receive insulin aspart as bolus insulin
    


Intervention name(s): insulin detemir; insulin NPH; insulin aspart
Intervention type(s): Drug; Drug; Drug
Intervention description(s): s.c. injection, once or twice daily.; s.c. injection, once or twice daily.; s.c. injection, at main meals.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin Detemir; Isophane Insulin, Human; Insulin, Isophane; Isophane insulin, beef
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Influence of Taping on Postural Control in Subjects With Chronic Ankle Instability
Condition: Chronic Ankle Instability
Study type: Interventional

Summary: 
      The main goal of this study is to evaluate the effect of taping on postural control during
      dynamic exercises. 30 subjects with Chronic ankle instability (CAI) will be included in the
      study. Several questionnaires regarding anthropometric data, medical history, activity level
      and functional status will be filled in by the participants. Postural control will be
      measured using a force plate and an optoelectronic system to capture lower limb kinematics.
      Subjects will be asked to perform a forward hop, sideward hop and a vertical drop, and they
      have to maintain their balance for 10 seconds after landing. 5 good trials of each movement
      will be captured. Subjects with CAI will perform these exercises with and without tape.
      Hypothesis is that subjects with CAI that tape will enhance postural control.
    


Intervention name(s): Taping the ankle
Intervention type(s): Procedure
Intervention description(s): Subjects will be taped in at the ankle for performing several exercises.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Pharmacokinetic Study to Compare the Blood Levels of Abatacept Manufactured at Lonza Biologics to the Blood Levels of Abatacept Manufactured at the Devens, Massachusetts (MA) Facility of Bristol-Myers Squibb
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether the blood levels of Abatacept (BMS-188667)
      drug product manufactured at Lonza Biologics and the Devens, MA facility of Bristol-Myers
      Squibb are comparable in healthy subjects
    

Detailed description: 
      Primary Purpose of this study is to compare the pharmacokinetic (PK) of Abatacept
      (BMS-188667) manufactured at Lonza relative to Abatacept (BMS-188667) manufactured at Devens,
      MA facility following a single intravenous infusion of 750 mg in healthy subjects
    

Intervention name(s): Abatacept (BMS-188667)
Intervention type(s): Biological
Intervention description(s): Solution for injection, Intravenous, 750 mg, Single dose, 1 day,
Other intervention name(s): BMS-188667
Intervention MeSH terms: Abatacept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Insulin Pump Therapy in Adolescents With Newly Diagnosed Type 1 Diabetes (T1D)
Condition: Diabetes Mellitus, Insulin-Dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Within 4 weeks after diagnosis of type 1 diabetes, 10 subjects (pubertal males, 12-17 years
      old) will be randomized to either receive multiple daily injection (MDI) using Lantus
      insulin, or continuous subcutaneous insulin infusion (CSII; pump therapy). The study
      evaluates how these modes of therapy affect insulin sensitivity (measured by the
      euglycemic-hyperinsulinemic clamp studies and adiponectin concentration changes) and beta
      cell function (measured by mixed meal tolerance testing).
    

Detailed description: 
      Within 4 weeks after diagnosis of type 1 diabetes, 10 subjects (pubertal males, 12-17 years
      old) will be randomized to either receive multiple daily injection (MDI) using Lantus
      insulin, or continuous subcutaneous insulin infusion (CSII; pump therapy). The proposed
      protocol compares the changes in diabetes control between pump therapy and MDI treatment
      groups. More importantly, however, the study evaluates how these modes of therapy may affect
      the honeymoon period and glycemic control, specifically focusing on changes in insulin
      sensitivity (measured by the euglycemic-hyperinsulinemic clamp studies and adiponectin
      concentration changes) and beta cell function (measured by mixed meal tolerance testing).
      Demonstrating that pump therapy at the time of diagnosis of type 1 diabetes prolongs the
      honeymoon phase by improving insulin sensitivity and beta cell function may have important
      therapeutic implications that could influence the standard of care in pediatric diabetes.
    

Intervention name(s): Insulin pump therapy; Multiple daily injections using insulin glargine + rapid acting analog
Intervention type(s): Device; Drug
Intervention description(s): CSII initiated within 1 month of diagnosis; MDI as control
Other intervention name(s): Continuous subcutaneous insulin infusion (CSII); MDI using glargine plus a rapid acting analog
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 1 diabetes; diabetes; new onset; CSII; insulin sensitivity; beta cell function; beta cell preservation
ENDOCUR - Modulation of Endotoxaemia Via Curcumin Intake in Healthy Overweight Adults
Condition: Overweight
MeSH terms: Endotoxemia; Overweight
Study type: Interventional

Summary: 
      Chronic diseases such as diabetes, cardiovascular diseases and cancer are a major burden on
      the Scottish population. Obesity and inflammation have strong links to these diseases. One of
      the mechanisms explaining the relationship between low-grade inflammation and excess weight
      is "endotoxaemia". We wish to study this phenomenon, when small components coming from our
      gut bacteria can pass into the bloodstream, raising the body's defences. Diet can modulate
      endotoxaemia. In this study, we propose to use curcumin, in a capsule form, to modulate
      endotoxaemia. Curcumin comes from turmeric, which is widely used as a spice. In this study,
      we want to test the effect of consuming curcumin extract to the composition of the gut
      microbiota, post-meal endotoxaemia, and inflammatory markers in blood.
    


Intervention name(s): BCM-95; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Consuming 1 capsule of BCM-95 per day.; Consuming 1 placebo capsule per day
Other intervention name(s): Bio-Curcumin
Intervention MeSH terms: Curcumin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Endotoxaemia, Curcumin.
To Access the Effect of Brain Pill™ on Working Memory Capacity and Mood Behaviour.
Condition: Memory Dysfunction; Mood Disorders
MeSH terms: Mood Disorders
Study type: Interventional

Summary: 
      Brain Pill™ is a mental health enhancing and successfully marketed dietary supplement.
    

Detailed description: 
      Brain Pill™ is a mental health enhancing and successfully marketed dietary supplement with a
      balanced composition of scientifically proven nutrients for accelerating and restoring brain
      function and thereby enhancing the cognitive performance and creating positive impact on
      behavioral outcomes.Hence the aim of the study is assessment of the effects of Brain Pill
      supplementation on memory performance in healthy adults with subjective memory complaints.

      It is a double-blind, randomized, placebo-controlled , single centered study to access the
      efficacy of Brain Pill on working memory capacity and mild mood disturbances.

      Effect of Brain Pill on working memory capacity will be accessed by improvement in mean
      response time and accuracy measured by working memory battery from baseline to end of the
      study. Effect of Brain Pill is also accessed on Neurophysiological improvement in working
      memory as measured by electroencephelogram (EEG) from baseline to end of the study. Also
      improvement in attention and concentration will be accessed from baseline to end of the study
      by Picture recognition test.

      Effect of Brain Pill on mood disturbances will be accessed by Brunel Universal Mood State.
    

Intervention name(s): Cognizin® SynapsaTM; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 capsules to be taken twice a day with meals with a glassful of water; 2 capsules to be taken twice a day with meals with glassful of water
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Biomechanical and Viscoelastic Properties of Plantar Fascia in Pregnant Women
Condition: Pelvic Girdle Pain; Biomechanical and Viscoelastic Properties of Plantar Fascia; Pregnant Woman
MeSH terms: Pelvic Girdle Pain
Study type: Observational

Summary: 
      Pelvic girdle pain is frequently experienced in pregnant women and the mechanism of pelvic
      girdle pain is not known exactly. The aim of this study is to investigate the effect of
      biomechanical and viscoelastic properties of plantar fascia on pelvic girdle pain in pregnant
      women.
    


Intervention name(s): Evaluation of biomechanics and viscoelastic properties of plantar fascia; Evaluation of navıcular drop; Evaluation of plantar pressure distrubution
Intervention type(s): Other; Other; Other
Intervention description(s): The biomechanical and viscoelastic properties of the plantar fascia will be measured in the side lying position.
Measurements will be made with the ankle in neutral position and maximum dorsi flexion position.; The amount of navicular drop of both feet will be measured; The distribution of foot plantar pressure and the amount of change in the center of gravity will be measured in the free standing position.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Pegnant women with pelvic girdle pain Pegnant women without pelvic girdle pain Non pregnant
        healthy women
      
Keywords: pelvic girdle pain, pregnant women, plantar fascia
Efficacy of SASI Bypass in Super Obese Patients
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      Although previous studies investigated weight loss and improvement in comorbidities after
      SASI bypass, patients included in these studies had a BMI less than 50 Kg/m2. Therefore, the
      aim of the present study was to investigate the outcome of SASI bypass in patients with super
      obesity to assess the success of this novel bariatric procedure in this challenging group of
      patients in regards weight loss and improvement in associated comorbid conditions at 12
      months postoperatively.
    


Intervention name(s): SASI bypass
Intervention type(s): Procedure
Intervention description(s): Sleeve gastrectomy with single loop anastomosis between gastric antrum and ileum, 3 meters away from ileocecal junction
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment