bioihbjkbjnl/mcl2 huggingface dataset:
Transdermal Delivery of Glucosamine to the Synovial Fluid of Male and Female With Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      Glucosamine is commonly used as a treatment for Osteoarthritis (OA). While oral
      administration remains the most commonly used route, topical administration could offer
      numerous advantages such as targeted delivery to affected joints and overcoming the negative
      effects of the passage of the drug through the digestive system. The objective of this study
      is to assess the bioavailability of glucosamine in the synovial fluid of osteoarthritic
      joints, following the topical application of a commercially available transdermal glucosamine
      cream. Joint fluid samples will be collected from 2 groups of participants with knee OA: the
      Control group will not be subjected to any treatment while the Test group will apply 2g of
      transdermal glucosamine cream 1 to 3 hours before the joint fluid collection. Glucosamine
      concentration will be determined and the results obtained from both groups will be compared.
      This trial will potentially provide data to support that glucosamine can cross the skin and
      be delivered to the affected joint fluid when formulated in a transdermal cream base.
    


Intervention name(s): Transdermal Glucosamine Cream
Intervention type(s): Drug
Other intervention name(s): TGC® Plus Capsaicin
Intervention MeSH terms: Capsaicin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects who agreed to participate in the study could decide to be part of the Control group (no intervention) or the Test group (single dose, topical application of Transdermal Glucosamine Cream)
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Transdermal Delivery; Glucosamine; Synovial Fluid; Osteoarthritis; Knee; Human; Arthrocentesis
Alzheimer's PET Imaging in Racially/Ethnically Diverse Adults
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The study employs tau positron emission tomography (PET) imaging in a well-characterized
      multi-racial/ethnic cohort to examine the extent to which tau pathology is associated with
      cognition, differences in tau pathology across racial/ethnic groups, and the relationship
      between MRI markers of small-vessel cerebrovascular disease and tau pathology. The study also
      investigates amyloid-dependent tau spreading.
    

Detailed description: 
      Deposition of hyperphosphorylated tau protein is observed in several neurodegenerative
      diseases including Alzheimer's Disease (AD), progressive supranuclear palsy, corticobasal
      degeneration, chronic traumatic encephalopathy, and frontotemporal lobar degeneration. Tau is
      a microtubular protein and its native function is to provide structural support to neurons.
      Paired helical filaments composed of dysfunctional tau protein are found in several
      neurodegenerative diseases. In AD, the clinical progression of dementia has been shown to
      correlate with the amount and topographical spread of tau throughout the brain. Therefore,
      detecting and quantifying tau aggregate load in brain would have diagnostic and prognostic
      potential in clinical management of several neurological diseases. As disease modifying drugs
      that target tau are being developed, there is a critical need for a reliable method of
      detecting tau aggregates to confirm pathology in patients entering clinical trials.
    

Intervention name(s): 18F-MK-6240; 18F-Florbetaben
Intervention type(s): Drug; Drug
Intervention description(s): Administration of 5 mCi of 18F-MK-6240 for tau PET.; Administration of 8.1 mCi as a slow single intravenous bolus (6 sec/mL) in a total volume of up to 10 mL of 18F-Florbetaben for Aβ PET imaging.
Other intervention name(s): [18F]MK-6240; [18F]Florbetaben
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Tau; Amyloid; MK-6240; Florbetaben; Racial/Ethnic Minority; Alzheimer's disease
Investigating the Pharmacokinetic Drug Interactions Between Rosuvastatin and Ezetimibe
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the pharmacokinetic drug interactions between
      Rosuvastatin and Ezetimibe in Healthy Male Subjects
    


Intervention name(s): Rosuvastatin 20mg; Ezetimibe 10mg; Rosuvastatin 20mg + Ezetimibe 10mg
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Rosuvastatin Calcium; Ezetimibe
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Granulocyte-Colony Stimulating Factor (G-CSF) as Optimizing Therapy for Pediatric Liver Transplantation
Condition: Liver Cirrhosis; Severe Malnutrition; PELD; Undernutrition
MeSH terms: Liver Cirrhosis; Malnutrition; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study compares the effect of human recombinant Granulocyte-Colony Stimulating Factor
      (G-CSF) in pediatric patients with liver cirrhosis with a control group. The study aims to
      observe improvement of (Pediatric End-stage Liver Disease) PELD score and nutritional status
      prior to liver transplantation procedure. In addition to the intervention, standard
      treatments for liver cirrhosis are also given for both groups. G-CSF is administered for 12
      times.

      Condition of disease:

      Pediatric patient aged 3 months to 12 years old Liver cirrhosis Undernourished / Severe
      malnutrition PELD score 10-25

      Intervention:

      Drug: Recombinant Human G-CSF

      Phase:

      Phase 3
    

Detailed description: 
      This open-label randomized control trial conducted in Cipto Mangunkusumo Hospital, Jakarta,
      Indonesia, aimed to determine the effect of G-CSF to improve PELD score and nutritional
      status of pediatric patients with liver cirrhosis prior to liver transplantation. A total of
      52 pediatric patients with liver cirrhosis, malnutrition and PELD score between 10-25 will be
      collected and divided into intervention group and control group. The intervention group will
      be given a subcutaneous injection of G-CSF 5μg/kg/day for 5 days consecutively, followed by a
      single dose every 3 days up to 12 times throughout the trial. Additionally, both the
      intervention and control group receive standard liver cirrhosis treatment. Randomization is
      done using block randomization.

      The patients will be clinically monitored and evaluated for anthropometric changes (body
      weight, mid-arm circumference, mid-arm muscle circumference, and triceps skinfold thickness),
      complete blood count, absolute neutrophil count, liver function tests, cytokines (IL-10,
      TNF-α), Procalcitonin, hepatocyte growth factor (HGF), CD34+ cell count and PELD score
      (albumin, bilirubin, prothrombin and international normalized ratio values).

      Data analysis will be performed using IBM SPSS Statistics version 20.0.0.
    

Intervention name(s): G-CSF (Filgrastim)
Intervention type(s): Drug
Intervention description(s): Contains 0,59 mg of acetate, 0,04 mg of polysorbate 80, 0,035 mg of sodium, 50 mg of sorbitol
Other intervention name(s): Neupogen
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Atomoxetine for Freezing of Gait in Parkinson's Disease
Condition: Parkinson's Disease; Freezing of Gait
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      Subjects are being asked to participate in this study to determine the safety and
      effectiveness of a drug called atomoxetine in the treatment of freezing of gait for
      Parkinson's Disease patients. Atomoxetine (ATM) is an approved drug currently on the market
      for the treatment of attention deficit. It works to increase the amount of norepinephrine (a
      chemical in the brain that helps keep us awake and alert) in our brain. ATM has not been
      approved by the Food and Drug Administration (FDA) to be used in the treatment of PD, but has
      been found to be well tolerated in this patient population.
    


Intervention name(s): ATM FOG in PD
Intervention type(s): Drug
Intervention description(s): open label pilot study on atomoxetine 40mg BID on patients with Parkinson's disease and Freezing of Gait
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of the Cryopreserved Formulation of OTL-101 in Subjects With ADA-SCID
Condition: Severe Combined Immunodeficiency Due to ADA Deficiency
MeSH terms: Severe Combined Immunodeficiency; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a prospective, non-randomized, single-cohort, longitudinal, single-center, clinical
      study designed to assess the efficacy and safety of a cryopreserved formulation of OTL-101
      (autologous CD34+ hematopoietic stem/progenitor cells transduced ex vivo with EFS (Elongation
      Factor 1α Short form) Lentiviral Vector (LV) encoding for the human ADA gene) administered to
      ADA-SCID subjects between the ages of >/=30 days and <18 years of age, who are not eligible
      for an Human Leukocyte Antigen (HLA) matched sibling/family donor and meeting the
      inclusion/exclusion criteria. The OTL-101 product is infused after a minimal interval of at
      least 24 hours following the completion of reduced intensity conditioning. For subjects who
      successfully receive the OTL-101 product, pegademase bovine (PEG-ADA) Enzyme Replacement
      Therapy (ERT) is discontinued at Day+30 (-3/+15) after the transplant. After their discharge
      from hospital, the subjects will be seen at regular intervals to review their history,
      perform examinations and draw blood samples to assess immunity and safety.
    


Intervention name(s): Infusion of autologous cryopreserved EFS-ADA LV CD34+ cells (OTL-101); Busulfan; Peg-Ada
Intervention type(s): Genetic; Drug; Drug
Intervention description(s): Autologous cryopreserved EFS-ADA LV CD34+ cells (OTL-101) are infused intravenously; Busulfan is used for non-myeloablative conditioning; Peg-Ada Enzyme Replacement Therapy (ERT) is discontinued at Day +30 (-3/+15 days) after successful engraftment
Other intervention name(s): OTL-101
Intervention MeSH terms: Busulfan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gene therapy; Hematopoietic stem and progenitor cells; Lentiviral vector; ADA-SCID
A Study to Evaluate the Efficacy and Safety of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This phase III study will evaluate the efficacy, safety and pharmacokinetics (PK) of
      recombinant human pentraxin-2 (rhPTX-2; PRM-151) zinpentraxin alfa, compared with placebo in
      participants with idiopathic pulmonary fibrosis (IPF).
    


Intervention name(s): PRM-151 (Zinpentraxin Alfa); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A 10 mg/kg IV infusion of PRM-151 based on the participants weight will be administered on Days 1, 3 and 5 followed by infusions Q4W to Week 48.; Placebo matching PRM-151 will be administered by IV infusion on Days 1, 3 and 5, followed by infusions Q4W to Week 48.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Accuracy of Depth and Landmark Assessment Using Neuraxial Ultrasound Devices
Condition: Pregnancy
Study type: Observational

Summary: 
      The purpose of this study is to determine if a handheld ultrasound device helps in the
      placement of labor epidurals by studying the accuracy of the Accuro Handheld Ultrasound
      device compared to a standard ultrasound machine.
    

Detailed description: 
      Pregnant women who present to Labor and Delivery for an anticipated vaginal delivery will be
      identified as potential participants based on inclusion/exclusion criteria and their desire
      for labor epidural analgesia. Ultrasound evaluations will be conducted in a cohort of 50
      parturients who decide they want epidural analgesia in labor. Prior to epidural placement, a
      hand held ultrasound device will be utilized to identify L2/3, L3/4 and L4/5 interspace. A
      mark will be made on the patient's back at these levels. The handheld ultrasound device will
      also estimate the depth to epidural space at each level using its programmed algorithm. A
      standard ultrasound will then be used to locate the same interspaces, identify midline, and
      estimate depth to epidural space with caliper calculation. Upon patient request, an epidural
      will be placed at L3/4 with a loss of resistance to saline technique. The actual depth to
      loss of resistance during epidural insertion will be determined by measuring the Tuohy with a
      sterile measuring tape while it is in the skin.
    

Intervention name(s): Accuro Handheld Ultrasound; Standard Ultrasound Machine
Intervention type(s): Device; Device
Intervention description(s): Use of an Accuro Handheld Ultrasound to identify lumbar interspaces, midline, and depth to epidural space; Use of standard ultrasound as gold standard to identify lumbar interspaces, midline, and depth to epidural space
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        50 parturients who decide they want epidural analgesia in labor
      
Keywords: Neuraxial; Ultrasound
Transcutaneous Electrical Acupoint Stimulation for the Treatment of ADHD
Condition: ADHD
Study type: Interventional

Summary: 
      RATIONALE: Transcutaneous electrical acupoint stimulation may improve attention deficit
      hyperactivity disorder (ADHD).

      PURPOSE: This randomized-controlled trial study of treating attention deficit hyperactivity
      disorder of school-aged children with transcutaneous electrical acupoint stimulation to see
      how well it works compared to sham transcutaneous electrical acupoint stimulation.
    

Detailed description: 
      OBJECTIVES:

      Primary

      To determine whether true transcutaneous electrical acupoint stimulation(TEAS) administered
      twice weekly for 4 weeks (8 sessions) compared to sham TEAS causes a significant improvement
      in symptoms of ADHD according to the investigator-rated Clinical Global
      Impression-Improvement (CGI-I) scores at week 4.

      Secondary

      To evaluate the changes from baseline to week 4 of Clinical Global Impressions Scale-Severity
      of Illness (CGI-S)，Conners'Parent Rating Scales-Revised: Short Form (CPRS-R: S) score,
      Conners'Teacher Rating Scales-Revised: Short Form (CTRS-R: S) score, go/no-go task
      performances, and the concentration of oxygenated hemoglobin within the prefrontal cortex.

      OUTLINE: This is a single-center study. Patients are randomized to two treatment arms.

      Arm I: Patients receive TEAS twice weekly for 4 weeks . Arm II: Patients receive sham TEAS
      twice weekly for 4 weeks .
    

Intervention name(s): Transcutaneous Electrical Acupoint Stimulation
Intervention type(s): Device
Intervention description(s): Patients in the experimental group will be treated for 20 min TEAS, twice a week, for a total of 4 weeks of treatment.The same intervention was performed in the sham group (electrode patches were attached at corresponding acupoints without electrical stimulation).
Acupoint selection: baihui (GV 20), taichong (LR 3), taixi (KI 3).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
ERAS After Bariatric Surgery in Morbidly Obese
Condition: ERAS; Obesity
Study type: Observational

Summary: 
      Recently, the number of bariatric surgery is increasing but ERAS (Enhanced Recovery After
      Surgery) protocol for bariatric surgery needs revision with evidence. So we investigated
      usefulness of ERAS protocol for bariatric surgery in morbidly obese patients.
    

Detailed description: 
      Patients undergoing elective laparoscopic bariatric surgery are going to be recruited and
      divided into 2 groups: Group E will receive ERAS protocol, and Group C will receive standard
      perioperative care.

      ERAS protocol comprises 8 hours of fasting and ingestion of oral carbohydrate 2 hour before
      surgery, TIVA(Total intra-venous anesthesia), TAP(transversus abdominis plane) block and
      IV-PCA using NSAIDs after surgery, and resumption of oral intake 2 hour after surgery.

      Conventional anesthesia is composed of 8 hours of fasting, inhalation anesthesia, IV-PCA
      using NSAIDs, and resumption oral intake 6 hour after surgery.

      In both groups, gastric ultrasonography will be used to measure gastric volume before
      surgery.

      Functional hospital stay will be recorded from the end of surgery until all discharge
      criteria had been met. Pain scores will be recorded at 30 minutes, 4 hours, and 24 hours
      after surgery. Also, nausea and vomiting, time to ambulation, will be documented. After the
      patients are discharged, their charts are going to be reviewed and their medical expenses
      will be documented.
    

Intervention name(s): ERAS protocol
Intervention type(s): Procedure
Intervention description(s): E: ERAS protocol C: control
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Morbidly obese patients undergoing elective laparoscopic bariatric surgery at Seoul
        National Bundang Hospital
Ambulation for Latency During Expectant Management of PPROM
Condition: Preterm Premature Rupture of the Membranes; Pregnancy Complications; Pregnancy, High Risk
MeSH terms: Pregnancy Complications; Rupture
Study type: Interventional

Summary: 
      Ambulation in pregnancy has been proposed to decrease stress and anxiety, increasing preterm
      birth. Whether ambulation is causally related to latency is unknown. The FitBit will be used
      for tracking the number of steps taken daily by each participant, and for encouraging the
      intervention group to walk. The FitBit is the most widely used physical activity tracker in
      medical research, and its use has been validated for research use in pregnant women. The
      purpose of the study is to evaluate whether ambulation in patients with preterm premature
      rupture of the membranes (PPROM) prolongs latency.
    


Intervention name(s): Ambulation Group; Routine Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants in the ambulation arm will be allowed ad lib activity and instructed that they should walk at least once per day out of their room with a goal of 2,000 steps per day. The Fitbit Inspire devices will be set to this goal and notifications will be given on the device for the participants meeting their goals; No encouragement to ambulate will be provided to subjects. Their movement will be recorded
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: pregnancy; PPROM
Evaluation of Patients With Covid-19 Infection in Terms of Severity of Osteoprosis
Condition: Severity of Osteoprosis
Study type: Observational

Summary: 
      Osteoporosis is a condition characterized by decreased bone strength and an increased risk of
      fracture. Age, gender, body mass index, fragility fracture history, corticosteroid use,
      immobilization, smoking and alcohol use, endocrine pathologies besides inflammatory and
      infectious pathologies can also be effective in the development of osteoporosis. The aim of
      the study is to evaluate the effect of Covid-19 infection on the development of osteoporosis.

      In this study, bone mineral density (BMD) measurements of patients with Covid-19 infection
      were examined. For this, dual-energy x-ray absorptiometry (DEXA) measurement was used. A
      total of 55 patients were included in the study and data such as age, height, weight,
      comorbidities, drugs used, and treatment methods were recorded. Results showed that the time
      spent in the intensive care unit was associated with the femoral neck T score in DEXA
      measurements of patients with Covid-19 infection. The use of drugs such as alendronate,
      zolendronate, denosumab or teriparatide during the treatment process did not have a
      statistically significant effect on the lumbar and femur T scores.
    


Intervention name(s): The patients were not intervened. This is a retrospective study
Intervention type(s): Other
Intervention description(s): The patients were not intervened. This is a retrospective study
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Between August 2020 and July 2021, two separate excel files were created for the
        identification numbers of the patients who had DEXA measurements and the identification
        numbers of the patients who had covid. Then, common ID numbers were found in both excel
        files in the computer environment. Among these patients, female patients over the age of 18
        who had dexa measurements twice before and after covid, with at least one year between two
        dexa measurements and at least one month after covid infection were included in the study.
Long-Term Follow-Up Studies at Year 6, 7, 8, 9, 10: 2 Formulations of Combined Hepatitis A/B Vaccine Compared in Subjects Aged 12-15 Years
Condition: Hepatitis B; Hepatitis A
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the persistence of anti-hepatitis A virus (anti-HAV) and anti-hepatitis B surface
      antigen (anti-HBs) antibodies up to 6, 7, 8, 9 and 10 years after administration of the first
      dose of the study vaccine.
    

Detailed description: 
      Open, randomized, long-term antibody persistence studies. Immune persistence was compared
      between subjects who received one of the two formulations of GlaxoSmithKline Biologicals'
      combined hepatitis A and hepatitis B vaccine according to a two-dose or three-dose schedule.
      These long-term follow-up studies involved taking blood samples at approximately 6, 7, 8, 9
      and 10 years after the primary vaccination of combined hepatitis A and B vaccine, to assess
      antibody persistence and a retrospective safety follow-up.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Intervention name(s): Twinrix™ Adult; Twinrix™ Junior
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular administration in the deltoid region (2 doses).; Intramuscular administration in the deltoid region (3 doses).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis B; TWINRIX™ Adult; Hepatitis A; TWINRIX™ Junior