bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Effectiveness Study of Allogeneic Umbilical Cord Blood-derived Mesenchymal Stem Cell in Patients With RDEB
Condition: Recessive Dystrophic Epidermolysis Bullosa
MeSH terms: Epidermolysis Bullosa; Epidermolysis Bullosa Dystrophica
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Previously, many studies have been conducted on mesenchymal stem cells derived from bone
      marrow or subcutaneous fat, but interest in cord blood-derived mesenchymal stem cell
      treatments has been increasing recently.

      In the case of cord blood as a source, the isolation of mesenchymal stem cells is easier than
      bone marrow or fat tissue, and cord blood-derived mesenchymal stem cells have an advantage as
      a treatment because they have faster population doubling time.

      To date, no clinical research on the treatment of patients using cord blood-derived
      mesenchymal stem cells has been reported in the literature, but there have already been
      registered at clinicaltrials.gov and currently being conducted overseas.

      In this study, we will study the safety and effectiveness of RDEB patient treatment using
      cord blood-derived mesenchymal stem cells with these advantages.
    

Detailed description: 
      Until now, all clinical trials for Recessive Dystrophic Epidermolysis Bullosa (RDEB) have
      examined the potential of bone marrow-derived MSCs. However, umbilical cord blood (UCB) is
      another important source of stem cells, since its non-invasive collection procedure and rapid
      availability from cord blood banking. Human UCB-derived MSCs (hUCB-MSCs) exhibit high
      proliferation capacity and low immunogenicity. A few data support that UCB-MSCs may have
      significantly greater immunosuppressive potential than other sources of MSCs. A preclinical
      study has demonstrated that systemic infusions of human UCB-derived unrestricted somatic stem
      cells, a subpopulation of non-hematopoietic stromal stem cells, significantly extended the
      life span and reduced blistering of RDEB mice model. Given the promising results of the
      preclinical study, we conducted a first-in-human, phase 1/2a clinical trial of intravenous
      administrations of allogeneic hUCB-MSCs in patients with RDEB to determine the safety,
      tolerability, and potential efficacy.
    

Intervention name(s): Human Umbilical Cord Blood-derived Mesenchymal Stem Cells
Intervention type(s): Drug
Intervention description(s): 3.0 x 106 cells/kg, IV, Total of 3 doses every 2weeks
Other intervention name(s): hUCB-MSCs; FURESTEM-CD Inj
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: umbilical cord blood-derived mesenchymal stem cell
The Effect of Laughter Yoga on Perceived Stress, Work Motivation, and Mental Well-Being
Condition: Mental Health; Complementary Therapies
Study type: Interventional

Summary: 
      The aim of this randomized controlled experimental study is to examine the effect of laughter
      yoga applied to intensive care nurses on perceived stress, work motivation, and mental
      well-being.
    

Detailed description: 
      The study was conducted with nurses working at Manisa Celal Bayar University Hospital's
      Surgical Intensive Care and Anesthesia Intensive Care units between December 2022 and March
      2023. The Nurse Introduction Form, Nurse Work Motivation Scale, Perceived Stress Scale, and
      Warwick-Edinburgh Mental Well-being Scale were used to collect data.
    

Intervention name(s): Laughter Yoga Application
Intervention type(s): Behavioral
Intervention description(s): The intervention group took eight sessions of laughter yoga, that is, two sessions per week for 4 weeks. The participants in the intervention group were asked to fill in the data collection tools before the laughter yoga sessions, and after the 4th and 8th yoga sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Laughter yoga; Perceived stress; Work motivation; Mental well-being
Safety and Efficacy of Repeated Infusion of CELYVIR in Children and Adults With Metastatic and Refractory Tumors.
Condition: Children; Solid Tumors; Metastases
MeSH terms: Neoplasm Metastasis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The investigators will evaluate the safety of weekly infusions (n=6) of CELYVIR in children
      and adults with metastatic and refractory solid tumors. CELYVIR consists in bone
      marrow-derived autologous mesenchymal stem cells (MSCs) infected with ICOVIR5, an oncolytic
      adenovirus. In addition to data on toxicities the investigators will evaluate clinical
      response.
    


Intervention name(s): CELYVIR
Intervention type(s): Biological
Other intervention name(s): Bone marrow-derived autologous mesenchymal stem cells infected with ICOVIR5, an oncolytic adenovirus.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mesenchymal stem cells; Oncolytic adenovirus
Immediate Implant With Cusomized Healing Abutment
Condition: Peri-implant Osteogensis
Study type: Interventional

Summary: 
      evaluate clinically and radiographically the effect of customized healing abutment on
      peri-implant osteogenesis following immediate implant placement.
    

Detailed description: 
      Now a day most people want to make immediate implant after extraction, which save them time
      and eliminates the need of second surgery. The problem is that the jummping gap between the
      implant and the bone that needs bone graft, this increase the cost on the patient. In this
      experiment we tend to evaluate this technique which may help us in growing autogenous bone
      and stop the need for bone grafting.

      The aim of this study is to evaluate clinically and radiographically the effect of customized
      healing abutment on peri-implant osteogenesis following immediate implant placement.

      A clinical trial was carried out on 8 patients (20-40 years old) with freshly extracted
      mandibular molars. Implants were placed immediately after extraction and a customized healing
      abutment will be fabricated. Patients were followed up clinically and radio graphically for 6
      months.
    

Intervention name(s): immediate implant with customized healing abutment
Intervention type(s): Other
Intervention description(s): All patients will be operated under local anesthesia.
Atraumatic extraction of the remaining root or tooth will be achieved.
A careful curettage of the socket will be performed if any granulation tissue is present.
Sequential drilling of the osteotomy site with copious irrigation will be done
The Implant is secured in place using a torque wrench.
Fabrication of the customized abutment with flowable composite by first placing a rubber dam between the abutment and the implant to prevent leakage of composite into the socket then start adding the composite in a manner to seal the socket.
Finishing the composite outside the patient's mouth will be done to ensure the borders are smooth with no sharp ends.
The abutment will be attached to the implant.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Fulvestrant Injection 50 mg/mL in Healthy Post-menopausal Female Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate bioequivalence between the test drug product,
      fulvestrant Injection, 50 mg/mL, and the Reference Listed Drug, Faslodex® Injection, 50
      mg/mL.
    

Detailed description: 
      This study is being conducted to establish bioequivalence between sponsor's test product
      [fulvestrant Injection, 50 mg/mL (Manufactured for Fresenius Kabi, USA)] and reference listed
      drug [Faslodex® Injection, 50 mg/mL, (Distributed by AstraZeneca Pharmaceuticals, USA] after
      intramuscular administration of a 250 mg dose (5 mL injection) into the upper outer quadrant
      of the right buttock to normal, healthy, nonsmoking post-menopausal female subjects.

      The order of receiving the test product (T) or reference listed drug (R) for each subject
      during the study will be determined according to a randomization schedule.

      Subjects will be allocated with a ratio of 1:1 to both treatment groups (i.e. T and R).
    

Intervention name(s): Fulvestrant; Fulvestrant
Intervention type(s): Drug; Drug
Intervention description(s): Single 5 mL intramuscular injection (slowly over 1-2 minutes) of Fulvestrant into the right buttock (upper outer quadrant); Single 5 mL intramuscular injection (slowly over 1-2 minutes) of Faslodex® (Fulvestrant) into the right buttock (upper outer quadrant)
Other intervention name(s): Faslodex
Intervention MeSH terms: Fulvestrant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Clinical Trial of Creatine in Amyotrophic Lateral Sclerosis [ALS]
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of creatine treatment
      in amyotrophic lateral sclerosis (ALS). There is currently no known effective treatment for
      ALS. It is known that nerve cells die in the brains and spinal cords of patients with ALS but
      the cause of the cell death is unknown. It has been shown that there is overactive nerve
      activity due to increased levels of a chemical called glutamate and that there is abnormal
      cellular metabolism along with increased production of substance called "free radicals."
      Improving cellular metabolism and readjusting the activity of glutamate in the brain may be
      beneficial to ALS patients.

      Creatine is a naturally occurring compound, which improves energy metabolism in cells.
      Creatine has been given to patients with energy metabolism defects in their muscles, and to
      athletes. Creatine improves survival in a mouse model of ALS. Three human subjects with ALS
      have received creatine for up to six months without any side effects. Overall, creatine has
      been well tolerated and safe.
    

Detailed description: 
      Half of the subjects in this study will be selected by chance to receive creatine treatment
      for 6 months and the other half to receive placebo. Neither the subject nor the investigator
      will know which drug the subject is receiving, although this information will be available in
      case of emergency. It is anticipated that all subjects will have the choice to receive
      creatine after the 6 months study in an open-label study for an additional 12 months. A total
      of 114 patients will participate at 15 centers. Approximately 8 subjects will be enrolled at
      the Washington University.

      The effectiveness of creatine will be determined first by assessing any changes in strength
      in the arms and second by changes in grip strength, functional activities, electromyography
      changes or changes of the level of SOH 2'dG in the urine.
    

Intervention name(s): Creatine
Intervention type(s): Drug
Primary purpose: Treatment
Unilateral Sequential Sympathectomy for Palmar Hyperhidrosis
Condition: Palmar Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Interventional

Summary: 
      Comparison between unilateral sequential and bilateral simultaneous endoscopic thoracic
      sympathectomy for palmar hyperhidrosis on patients outcomes notably compensatory
      hyperhidrosis.
    


Intervention name(s): bilateral simultaneous endoscopic thoracic symapthectomy; unilateral sequential endoscopic thoracic symapthectomy.
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients underwent bilateral simultaneous T2-T3 ganglionectomy using thoracoscopic approach.; Patients underwent unilateral T2-T3 ganglionectomy of the dominant side followed by T2-T3 ganglionectomy of the other side after 2 months interval.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Palmar hyperhidrosis; Endoscopic thoracic sympathectomy
Bioequivalency Study of Morphine Sulfate Injection, Solution and Tablet Under Fasted Conditions
Condition: Pain
Study type: Interventional

Summary: 
      Determine the pharmacokinetics and optimize study design for subsequent studies with morphine
      sulfate tablets and solution.
    


Intervention name(s): morphine sulfate
Intervention type(s): Drug
Intervention description(s): morphine sulfate 30 mg tablet, morphine sulfate 30 mg (10 mg / 5 mL) oral solution, morphine sulfate injection 10 mg (1 mg / mL)
Other intervention name(s): DURAMORPH
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of Virtual Reality/ Augmented Reality Usage on Oral Care Knowledge in Nursing Students
Condition: Virtual Reality; Oral Care; Knowledge, Attitudes, Practice
Study type: Interventional

Summary: 
      The aim of this study was to investigate the effects of virtual reality usage on oral care
      knowledge in nursing students. The participants were randomly assigned to virtual-reality
      experimental and control groups. The students in experimental group received a 30 minutes
      virtual reality (VR) training for elderly oral health care at the second week and the fourth
      week after the first time survey. All students self-administrated questionnaire three times
      at first date of consent form signed, immediately after each of the intervention for period
      of two weeks. Linear regression in generalized estimating equations (GEE) compare the
      differences between both groups.
    

Detailed description: 
      A total of 50 first-year to third-year undergraduate nursing students were included from the
      Department of Nursing, Kaohsiung Medical University, Taiwan. The students were randomly
      assigned divided at random into two groups, control (n = 25) and experimental (n = 25).
    

Intervention name(s): Virtual Reality Usage on Oral Care Knowledge
Intervention type(s): Other
Intervention description(s): Virtual Reality Usage on Oral Care Knowledge about independent older adults
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Effect of Insulin Resistance Reducing Agents Pre and Post CABG on Post-operative Metabolic Status and Oxidative Stress
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Insulin Resistance
Study type: Interventional
Phase: Phase 2

Summary: 
      The present study aimed to evaluate the effect of a combination of insulin resistance
      reducing agents pre and post coronary artery bypass grafting surgery on post-operative blood
      glucose and oxidative stress regulation.
    

Detailed description: 
      The present study aimed to evaluate the effect of a combination of insulin resistance
      reducing agents pre and post coronary artery bypass grafting surgery on post-operative blood
      glucose and oxidative stress regulation. The sample size was estimated to be 92 (23 in each
      group). The participants of the study were selected from the non-diabetic patients scheduled
      for CABG. The patients were allocated to four groups using balanced block randomization
      method:

        1. Consumption of the supplement (a 20 gram pack of the supplement daily) 7 days before
           surgery and placebo (a pack of starch) 30 days post surgery

        2. Consumption of placebo 7 days before surgery and supplement 30 days post surgery

        3. Consumption of the supplement 7 days before and 30 days post surgery

        4. Consumption of placebo 7 days before and 30 days post surgery One week before, before
           the onset of the surgery, after the surgery, 1 week after and 4 weeks after the
           operation, blood samples were taken and the levels of hemoglobin A1C, glucose, insulin
           and malondialdehyde were measured. Also, body composition indices were assessed in four
           times: one week before the surgery, before the onset of the surgery, 1 week after and 4
           weeks after the surgery.
    

Intervention name(s): Supplement pre CABG; Supplement post CABG; Supplement pre and post CABG; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Drug
Intervention description(s): One sachet of the supplement was consumed daily for 7 days before surgery.; One sachet of the supplement was consumed daily for 30 days after surgery; One sachet of the supplement was consumed daily for 7 days before surgery and 30 days after CABG; One sachet of placebo was consumed daily for 7 days before surgery and 30 days after CABG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: insulin resistance; blood glucose; CABG; oxidative stress
Drug Interaction Between CKD-501 and Metformin
Condition: Healthy Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate safety, tolerance by comparing availability and the
      pharmacokinetic drug interaction between the CKD-501 and metformin when administered alone
      and combination to healthy male volunteers.
    

Detailed description: 
      Volunteers doses three times over the period of CKD-501 0.5mg and metformin 1000mg alone,
      repeated doses are five days.

      In addition, the CKD-501 0.5mg and metformin 1000mg are administered simultaneously be used
      repeatedly to five days.

      Every time before and after each medication safety and drug absorption, distribution,
      metabolism and excretion rate, and is expected to conduct some tests.
    

Intervention name(s): Metformin; CKD-501
Intervention type(s): Drug; Drug
Intervention description(s): CKD-501 0.5mg, metformin 1000mg; CKD-501 0.5mg, metformin 1000mg
Other intervention name(s): Lobeglitazone; Lobeglitazone
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Mellitus, type 2; pharmacokinetic evaluation; drug interaction between CKD-501 and metformin
Immunogenicity and Safety of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Children and Adolescents in Latin America
Condition: Dengue; Dengue Hemorrhagic Fever; Dengue Virus; Dengue Fever
MeSH terms: Dengue; Hemorrhagic Fevers, Viral; Severe Dengue; Fever; Hyperthermia
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary objectives:

        -  To describe the immune response to each dengue serotype before and after each
           vaccination with sanofi pasteur's CYD dengue vaccine.

        -  To evaluate the safety of each vaccination with sanofi pasteur's CYD dengue vaccine.
    

Detailed description: 
      The antibody levels against each serotype will be measured before and after each vaccination.
      The subjects will be followed for 28 days after each vaccination for solicited and
      unsolicited safety parameters. Serious adverse events (SAEs) will be collected throughout the
      study.
    

Intervention name(s): CYD Dengue Vaccine; Tetanus Toxoid Reduced Diphtheria Toxoid Acellular Pertussis
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Subcutaneous at Day 0, 6 and 12 months; NaCl: 0.5 mL, Intramuscular at Day 0 and 6 months; Adacel®: 0.5 mL, Intramuscular at 12 months
Other intervention name(s): Dengvaxia®; ADACEL®; NaCl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dengue; Dengue hemorrhagic fever; Dengue virus; Dengue fever; Sanofi pasteur's CYD Dengue vaccine
Woodsmoke Exposure and Cardiovascular Function
Condition: Respiratory Inflammation; Systemic Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      Air pollution is linked to respiratory and cardiovascular disease. Wood smoke is a common air
      in many parts of the world and previous studies indicate that wood smoke induce oxidative
      stress in the respiratory tract. It is not determined how different types of biomass
      combustion affect human health. In this study the investigators plan to investigate how
      inhalation of wood smoke and pellets smoke affect respiratory and cardiovascular health.
    


Intervention name(s): Bronchoscopy
Intervention type(s): Other
Intervention description(s): 24 hours after exposure, a bronchoscopy will be performed to allow analysis of cells and inflammatory markers in bronchial wash, bronchioalveolar lavage and lung biopsies.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Wood smoke; inflammation; lung function; arterial stiffness; heart rate variability; Respiratory and systemic inflammation following exposure to woodsmoke in healthy volunteers
An Extension Study for Participants Who Have Completed the Treatment Period of a Qualifying Parent Study
Condition: Dermatomyositis
MeSH terms: Dermatomyositis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to evaluate the long-term safety, and tolerability of
      PF-06823859 study drug in adult participants with Dermatomyositis (DM) from a qualifying
      study.
    


Intervention name(s): Anti-Beta Interferon (PF-06823859)
Intervention type(s): Drug
Intervention description(s): IV infusion
Intervention MeSH terms: Interferons; Interferon-beta
Intervention model: Single Group Assignment
Intervention model description: Eligible participants will have completed the treatment period of a qualifying Dermatomyositis parent study. All participants will receive active study drug.
Masking: None (Open Label)
Primary purpose: Treatment