bioihbjkbjnl/mcl2 huggingface dataset:
Phase III Clinical Trial of CinnaGen COVID-19 Vaccine (SpikoGen)
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a phase III, randomized, two-armed, double-blind, placebo-controlled trial designed
      to evaluate the efficacy and safety of a candidate adjuvanted recombinant SARS-CoV-2 spike
      (S) protein subunit vaccine (SpikoGen) produced by CinnaGen Co. 16,876 adult individuals
      receive either SARS-CoV-2 recombinant spike protein (25 µg) with Advax-SM adjuvant (15 mg) or
      saline placebo in a 3:1 ratio. The randomization is stratified by age (from 18 to under 40
      years of age or from 40 to under 50 years of age). The injection is given in two doses with a
      21-day interval in the deltoid muscle of the non-dominant arm. Participants will be followed
      up for six months after the second dose of the study intervention.

      Study hypotheses include:

        1. The adjuvanted COVID-19 vaccine candidate significantly reduces the risk of symptomatic
           COVID-19 in adult subjects.

        2. The adjuvanted COVID-19 vaccine candidate significantly reduces the risk of severe
           COVID-19 in adult subjects.

        3. The adjuvanted COVID-19 vaccine candidate is safe and tolerable in adult subjects.
    


Intervention name(s): SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant; Saline placebo
Intervention type(s): Biological; Biological
Intervention description(s): SARS-CoV-2 recombinant spike protein (25 µg) with Advax-SM adjuvant (15 mg) in two doses with a 21-day interval administered with intramuscular injections in the deltoid muscle of the non-dominant arm; 0.9% sodium chloride (1 mL) injection in two doses with a 21-day interval administered with intramuscular injections in the deltoid muscle of the non-dominant arm
Other intervention name(s): SpikoGen; Normal saline
Intervention MeSH terms: Myeloma Proteins; Paraproteins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: COVID-19; SARS-COV-2; Recombinant protein; Spike; Advax-SM; Advax; Vaccine; Adjuvant
Effectiveness of Different Physiotherapy Practices in Temporomandibular Disorders
Condition: Temporomandibular Disorder
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional

Summary: 
      The aim of the study is to examine the effect of high voltage electrical stimulation on pain,
      temporomandibular joint mobility, cervical mobility, head position, tender points and joint
      sounds in individuals with temporomandibular disorders.
    

Detailed description: 
      28 individuals who meet the TMER / Research Diagnostic Criteria classification will be
      randomly divided into 2 groups. Exercise with high voltage electrical stimulation (YVES) will
      be applied to the 1st group and only exercise will be applied to the 2nd group. The second
      group will be the control group of the study. Both groups will be informed about the disease
      before starting the study before the treatment and patient education will be given about the
      situations that need attention. Again, 2 groups will be given an exercise program from the
      day they start the treatment, 3 times a week for 4 weeks during the treatment. As
      sociodemographic information of the individuals, age, gender, height, weight, body mass
      index, marital and educational status, occupation, smoking and alcohol use, patient history,
      family history and complaint sides will be recorded. Before starting treatment, individuals
      will be evaluated for pain, temporomandibular joint mobility, cervical mobility, tender
      points, and joint sounds:

        1. Pain with Visual Analogue Scale (VAS),

        2. TMJ mobility with a ruler,

        3. Cervical mobility with C-ROM (Cervical Range of Motion) inclinometer,

        4. Head position with universal goniometer and ImageJ software,

        5. Sensitive points with algometer,

        6. Joint sounds will be evaluated as present / absent as a result of the evaluation of
           movements in all directions (maximum mouth opening, right / left lateral excursions,
           protrusion and retrusion).

      After 4 weeks of treatment, the measurements will be repeated.
    

Intervention name(s): High voltage electrical stimulation+exercise therapy; Exercise therapy
Intervention type(s): Other; Other
Intervention description(s): The effect of high voltage electrical stimulation on temporomandibular disorders; The effect of high voltage electrical stimulation on temporomandibular disorders
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized-controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: High voltage stimulation; Temporomandibular disorders; Temporomandibular joint; Cervical spine; Pain
A Study to Evaluate Changes in Smokers Using An Oral Tobacco-Derived Nicotine Product
Condition: Tobacco Use
Study type: Interventional

Summary: 
      The purpose of this study was to estimate changes in biomarkers of exposure (BOE) in adult
      cigarette smokers using an oral tobacco-derived nicotine (OTDN) product relative to adult
      smokers who continue smoking exclusively.
    

Detailed description: 
      This was a randomized, controlled, open-label, parallel group, multicenter, 9-week study to
      determine changes in BOE in adult smokers allowed ad libitum use of an OTDN product relative
      to adult smokers who were not allowed to use an OTDN product. This study was conducted in
      adult smokers who were considered to be in overall good health. Subjects were randomized to
      Test (allowed OTDN use) or Control (not allowed OTDN use) groups.
    

Intervention name(s): Oral tobacco-derived nicotine product (OTDN)
Intervention type(s): Other
Other intervention name(s): VERVE® Discs Blue Mint
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Allogeneic Mesenchymal Stromal Cell Therapy in Renal Transplant Recipients
Condition: Rejection; Graft Loss
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will test whether selected allogeneic bone marrow derived MSCs are safe by
      assessing the composite end point Biopsy Proven Acute Rejection (BPAR)/ graft loss at 12
      months.
    

Detailed description: 
      Kidney transplantation has improved survival and quality of life for patients with end-stage
      renal disease. However, despite advances in immunosuppressive therapy, long-term allograft
      survival outcomes have not improved over the last decade.

      A promising novel therapeutic immunosuppressive option in the treatment of renal recipients
      with a profound effect on the fibrosis reaction is the clinical application of mesenchymal
      stromal cells (MSCs). Allogeneic MSCs offer the advantage of availability for clinical use
      without the delay required for expansion.

      Although it is believed that allo MSCs are immune privileged, they could possibly elicit an
      anti-donor immune response, which may increase the incidence of rejection/ graft loss and
      impact the allograft survival on the long term. These safety issues should be studied before
      further studies are planned with allogeneic MSCs in the transplant setting.

      MSCs are infused at a time point when immune suppression is lowered and the kidney is at
      increased risk for developing immune mediated injury. In addition, a large amount of the
      kidneys already has signs of fibrosis at this time point and MSCs might reduce the fibrosis
      which so importantly affects long term survival. MSCs will have no Human Leucocyte Antigen
      (HLA) sharing with the mismatches of the donor and the recipient should have no antibodies
      directed to the MSCs to reduce the anti-donor immune respons risk.
    

Intervention name(s): mesenchymal stromal cells
Intervention type(s): Drug
Intervention description(s): 2 doses of 1-2x10^6 allogeneic bone marrow derives MSCs IV per/kg body weight at weeks 25 and 26 after transplantation
Other intervention name(s): MSC; bone marrow derived mesenchymal stromal cells
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mesenchymal Stromal Cells; Rejection
Prevention of Weight Gain in Adult Patients With Type 2 Diabetes Treated With Pioglitazone
Condition: Type 2 Diabetes; Obesity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Weight Gain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to investigate the effectiveness of three lifestyle treatment
      programs varying in level of intensiveness on prevention of pioglitazone-induced weight gain
      and to measure the composition of the change in body weight.
    

Detailed description: 
      The three lifestyle interventions were usual care (1 visit), standard care (4 total visits)
      and intensive care (10 total visits)
    

Intervention name(s): Lifestyle modification
Intervention type(s): Behavioral
Intervention description(s): lifestyle intervention includes meal planning, food preparation, food label reading, dining out, and physical activity counseling
Other intervention name(s): lifestyle behavioral counseling
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: type 2 diabetes; obesity; weight gain; thiazolidinediones
Safety, Tolerability and Immunogenicity Study of AV7909 Anthrax Vaccine in Healthy Adults
Condition: Bacillus Anthracis (Anthrax) Infection
MeSH terms: Anthrax
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this Phase 1 clinical trial is to evaluate the safety, tolerability, and
      immunogenicity of AV7909 anthrax vaccine in healthy adults. In this study, healthy male and
      female subjects between 18 and 50 years of age will receive vaccinations via the
      intramuscular (IM) route at Days 0 and 14. Safety and tolerability will be evaluated via
      laboratory tests, physical examinations, vital signs, adverse events (AEs), concomitant
      medications, and local and systemic signs and symptoms of reactogenicity.
    

Detailed description: 
      AV7909 is a new vaccine which is a combination of BioThrax (also called anthrax vaccine,
      adsorbed or AVA), a FDA-licensed vaccine, and CPG 7909. CPG 7909 is a synthetic short DNA
      sequence that has been shown to be an effective vaccine adjuvant, and one which increases the
      speed and the degree of the immune response to Protective Antigen (PA), the major vaccine
      antigen. In the current study, the safety, tolerability, and antibody response to PA will be
      studied for four different combinations of AVA and CPG 7909, and compared to both AVA and a
      saline placebo. All formulations of AV7909 have the same or less AVA than the licensed AVA
      vaccine and all have less CPG 7909 per dose than the formulation used in the first Phase I
      volunteer study of CPG 7909 combined with AVA.
    

Intervention name(s): BioThrax; AV7909 Formulation 1; AV7909 Formulation 2; AV7909 Formulation 3; AV7909 Formulation 4; Control
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Drug
Intervention description(s): BioThrax; AV7909 Formulation 1; AV7909 Formulation 2; AV7909 Formulation 3; AV7909 Formulation 4; Saline control
Other intervention name(s): Anthrax Vaccine Adsorbed (AVA)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: AVA; AV7909; Anthrax vaccine
Safety and Efficacy of House Dust Mite Allergen Extract in the Treatment of Allergic Rhinoconjunctivitis
Condition: House Dust Mite Allergy
MeSH terms: Dust Mite Allergy
Study type: Interventional
Phase: Phase 4

Summary: 
      The trial is performed to assess efficacy and safety of Novo-Helisen Depot in allergic
      Rhinoconjunctivitis
    


Intervention name(s): House dust mite Novo Helisen Depot
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: House dust mite,; Allergy
A Clinical Trial to Evaluate the Immunogenicity and Safety of sIPV in a "2+1"Sequential Schedule With bOPV in Infants
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this phrase III clinical trial is to evaluate the immunogenicity and safety of
      Sabin Inactivated Poliovirus Vaccine (Vero cell) in a '2+1'sequential schedule with bivalent
      oral poliovirus vaccine in 2-month-old infants
    

Detailed description: 
      his study is a randomized, double-blind, active-controlled phrase III clinical trial. The
      purpose of this study is to evaluate the immunogenicity and safety of sIPV manufactured by
      Sinovac Biotech Co., Ltd in a '2+1' sequential schedule with bOPV in 2-month-old infants. 240
      infants aged between 60-90 days will be randomly assigned into experimental group or control
      group in the ratio 1:1. The experimental group received sIPV-sIPV-bOPV vaccination schedule
      at one month doses interval (i.e., month 0, 1, 2), and the control group received
      wIPV-wIPV-bOPV vaccination schedule at one month doses interval (i.e., month 0, 1, 2). The
      control wIPV was manufactured by SANOFI PASTEUR S.A.
    

Intervention name(s): sIPV-sIPV-bOPV vaccination schedule; wIPV-wIPV-bOPV vaccination schedule
Intervention type(s): Biological; Biological
Intervention description(s): Two intramuscular injections of the investigational vaccine (0.5 ml) on Day 0 and Day 30 respectively; Single dose of bOPV (0.1 ml) on Day 60. The investigational Sabin strain inactivated poliovirus vaccine (Vero cell)(sIPV) was manufactured by Sinovac Biotech Co., Ltd . The poliovirus (Live) vaccine type I & type III (Human Diploid cell) ( bOPV) was manufactured by Beijing Bio-institute Biological Products Co., Ltd.; Two intramuscular injections of the control vaccine(0.5 ml) on Day 0 and Day 30 respectively; Single dose of bOPV (0.1 ml) on Day 60. The investigational Sabin strain inactivated poliovirus vaccine (Vero cell)(sIPV) was manufactured by SANOFI PASTEUR S.A. The poliovirus (Live) vaccine type I & type III (Human Diploid cell) ( bOPV) was manufactured by Beijing Bio-institute Biological Products Co., Ltd.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Sabin strain; Inactivated poliovirus vaccine; poliomyelitis; safety; immunogenicity; infant; sequential schedule
Safety Sudy of Atazanavir Boosted With Ritonavir in the Treatment of HIV Infection in Pediatric Patients
Condition: HIV, Pediatric
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to collect safety clinical data in HIV-infected pediatric
      patients aged 6 and older to younger than18 years and weighing 15 kg or more, who are
      receiving atazanavir capsule boosted with ritonavir and an optimized nucleoside reverse
      transcriptase inhibitor backbone therapy as part of their antiretroviral regimen.
    


Intervention name(s): Atazanavir; Ritonavir
Intervention type(s): Drug; Drug
Other intervention name(s): Reyataz; BMS-232632; Norvir
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Interleukin (IL)-13 as a Marker in Pediatrics Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      Asthma is a very common childhood chronic illness and is generally more severe in African
      Americans. The investigators attempted to determine whether a specific immune marker is
      associated with lung function and asthma severity.
    

Detailed description: 
      This study examined the relationship between Interleukin (IL)-13 from
      phytohemagglutinin-activated polymorphonuclear blood cells and asthma severity, lung function
      (measured as FEV1%), and total serum IgE levels in African American children with clinically
      diagnosed asthma
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        African-American children, ages 8 to 15 years, with clinically diagnosed asthma which had
        been stable for at least 4 weeks prior to enrollment in the study.
      
Biospecimen description: 
      Venous blood was obtained to measure total serum immunoglobulin E, radioallergosorbent test
      for environmental aeroallergens, and for peripheral blood mononuclear cells isolation
    
Keywords: African American children with stable asthma; Asthma severity; Interleukin 13 from PHA stimulated PBMC; Lung function (FEV1%); Total serum IgE; Pediatrics
Somatization, Anxiety, and Disordered Sleep in Pediatric Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Observational

Summary: 
      Eosinophilic esophagitis
    

Detailed description: 
      In order to decrease disease burden and the perception of disease burden, investigators need
      to understand the symptoms and severity of anxiety, disordered sleep, and somatization and
      how these parameters align with symptoms and quality of life in pediatric EoE. To assess the
      burden of these parameters in children with EoE, investigators will conduct a single center
      pilot study of 60 children with EoE using validated indexes for anxiety (state trait anxiety
      inventory for children), somatization (children's somatization inventory), sleep (pediatric
      sleep questionnaire), coping (Connor-Davidson Resilience Score) symptoms (PEESSv2.0), and
      quality of life (PedsQL-EoE).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children 8-18 years old seen in the Rady Children's EoE clinic population as part of
        routine care (n=60) patients
      
Keywords: EoE
Safety of Lactobacillus Reuteri in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase one study to assess the safety of daily dosing of Lactobacillus reuteri in
      healthy adults in Peru. It is conducted as a preliminary study in support of a clinical trial
      to assess safety and efficacy of Lactobacillus reuteri versus placebo for treatment of
      pediatric diarrhea in Peru.
    

Detailed description: 
      This is a phase I blinded randomized study of the safety and tolerability of Lactobacillus
      reuteri DSM 17938 given daily for a period of five consecutive days. Upon enrollment subjects
      will be randomized to one of two treatment groups in a ratio of treatment to placebo of 2:1.
      Subjects will be randomized to receive either:

      A. Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose,
      given once daily for a five-day treatment period that corresponds to a dose of the closely
      related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic.
      The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid
      found in the original BioGaia strain (L. reuteri ATCC 55730).

      B. Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing
      the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm,
      Sweden).
    

Intervention name(s): Lactobacillus reuteri; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period; 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period
Other intervention name(s): BioGaia Probiotic Drops
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: probiotics; lactobacillus; reuteri; none (safety only)
Effect of Cricoid Pressure on Macintosh, McGrath X-Blade and Glidescope Videolaryngoscopes in Rapid Sequence Induction Intubation
Condition: Rapid Sequence Induction Intubation
Study type: Interventional
Phase: Phase 4

Summary: 
      Non- Fasted patients need rapid sequence intubation. The investigators aimed to compare the
      intubation times of Macintosh , and McGrath X-Blade or Glidescope in these Ascenario.
    

Detailed description: 
      The investigators fecidedir to enroll the ASA I-II 120 patients and divided them into three
      groups ( Macintosh / McGarth X-Blade / Glidescope). The investigators recorded the patients'
      airway data and demographic variables. All patients were premeditated with midazolam.
      Standard monitoring including electrocardiogram, non invasive blood pressure, pulse oximetry,
      heart rate were recorded before induction , after induction, after the device insertion and
      every 1 minutes after intubation. Cormac-Lehan grades with these video laryngoscope were
      recorded also. We recorded the optimization maneuvers ( like handling force, reinserting,
      cricoid pressure). Bloodstaining on the devices after removal were recorded as mucosal
      damage. Teeth, tongue, lip damage were also recorded. Sore throat, bronchospasm, wheezing
      were recored at recovery unit.
    

Intervention name(s): Macintosh; Glidescope; McGrath MAC X-Blade
Intervention type(s): Device; Device; Device
Intervention description(s): Direct laryngoscopy; Glidescope videolaryngoscope; McGrath MAC X-Blade videolaryngoscope
Other intervention name(s): direct laryngoscopy; videolaryngoscope; videolaryngoscope
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Rapid sequence induction intubation; McGrath X-Blade; Glidescope; Macintosh
Effect of Weight Loss Diet and Pumpkin Seed Flour Consumption on Obese Women
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This study aimed to evaluate the effect of weight loss diet combined with pumpkin seed flour
      consumption on diet improvement, weight loss, and glucose and cholesterol reduction in obese.
    


Intervention name(s): pumpkin seed flour; Placebo (cassava flavored flour)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The pumpkin seed flour group received 20g/day of pumpkin seed flour during 12 weeks; The group placebo (cassava flour flavored) received 20g/day of cassava flour flavored during 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: obesity; cardiovascular risk factors; pumpkin seed; diet quality