bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 1 Multiple-Dose Escalation and Single Dose (Tablet) Study of PF-04171327 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability, pharmacokinetics and
      pharmacodynamics (how the drug effects certain target sites of activity in the body) of
      escalating doses of oral PF-04171327 in healthy volunteers for 14 days (Part 1). Part 2 will
      evaluate the pharmacokinetics of a single 10 mg dose of the PF-04171327 tablet in healthy
      volunteers.
    


Intervention name(s): PF-04171327; Prednisolone; Placebo; Placebo Solution; PF-04171327 Tablet
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): PF-0417327 will be provided as an oral solution administered at doses of 1, 3, 10 and 30 mg. If an additional cohort is required, the dose selected will not exceed 100 mg. Solution will be administered once daily for 14 days.; Oral doses of prednisolone (5, 10, and 20 mg) will be administered to the first three cohorts. The fourth cohort will receive between 1 and 20 mg to be determined after the third cohort completes dosing. If an additional cohort is required, the dose selected will not exceed 40 mg. Prednisolone tablets will be administered once daily for 14 days; Tablets similar in appearance to prednisolone will be administered once daily for 14 days.; Placebo solution will be administered to those volunteers who are randomized to the placebo or prednisolone arms. This will be administered orally each day for 14 days.; A single 10 mg dose of PF-04171327 tablet formulation will be administered orally to volunteers in Part 2 of this study.
Intervention MeSH terms: Prednisolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Safety Tolerability Pharmacokinetics/pharmacodynamics
Longitudinal Follow up to Assess Biomarkers Predictive of Emphysema Progression in Patients With COPD (Chronic Obstructive Pulmonary Disease)
Condition: Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
Study type: Observational

Summary: 
      The study will include 60 healthy subjects (ex-smoker without any airflow limitation), 125
      COPD GOLD (global initiative for chronic obstructive lung disease) I , 125 COPD GOLD II, 125
      COPD GOLD III and up to 20 patients with COPD and A1AT (Alpha1-Antitrypsin) deficiency (ZZ
      genotype). Soluble and imaging biomarkers will be investigated addressing different aspects
      of disease pathways postulated to be relevant for COPD progression.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers and COPD patients
      
Biospecimen description: 
      Soluble and imaging biomarkers
Contrast-enhanced Magnetic Resonance Imaging With Polysaccharide Superparamagnetic Iron Oxide Nanoparticle
Condition: Magnetic Resonance Imaging
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a contrast-enhanced magnetic resonance imaging (MRI) study conducted on a
      single-administration of polyglucose superparamagnetic iron oxide injection. Two dose groups
      are set up in this study, 2.5 mg/kg and 3 mg/kg, and two subjects in each group received the
      test drug for safety evaluation.
    


Intervention name(s): polysaccharide superparamagnetic iron oxide injection
Intervention type(s): Drug
Intervention description(s): Polysaccharide superparamagnetic iron oxide injection is a magnetic resonance contrast agent.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Backup With Combivir or Single Dose (SD) Truvada in Order to Avoid Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) Resistance After SD Nevirapine for the Prevention of Mother-to-child Transmission (PMTCT)
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      The aim of the study is to find short course alternatives to single dose (sd)nevirapine for
      the prevention of mother-to-child HIV-transmission with the same or better degree of
      transmission protection than sd nevirapine but with less NNRTI resistance development.
    

Detailed description: 
      Randomised open study comparing Zidovudine from 28 weeks gestation, single dose Nevirapine +
      1 week of Combivir with Zidovudine from 28 weeks gestation, single dose Nevirapine + single
      dose of Truvada for the mothers during birth. In both arms the infants will receive one dose
      of nevirapine within the first days after births as well as 7 to 28 days Zidovudine. N = 450.
      The study will be conducted at Ngamiani and Makorora Health Centres and Bombo Regional
      Hospital in Tanga, Tanzania as a cooperation between Rigshospitalet, Denmark, University of
      Copenhagen and National Institute of Medical Research, Tanzania.
    

Intervention name(s): Zidovudine and Lamivudine (Combivir); Emtricitabine and Tenofovir (Truvada)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Tenofovir; Lamivudine; Emtricitabine; Zidovudine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Lamivudine, zidovudine drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: mother-to-child-transmission; PMTCT; HIV; resistance; NNRTI
Erbium Chromium: YSGG Laser Effect on Surgical Treatment of Chronic Periodontitis
Condition: Generalized Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

Summary: 
      Microbiological and Clinical assessment of Er,Cr:YSGG laser in conjunction to open flap
      debridement (OFD) in treatment of chronic periodontitis through real time PCR assay for
      quantification of total bacterial load.
    

Detailed description: 
      Two groups are randomly allocated (random number generation) by Microsoft excel into two
      groups :

        1. Group (1) Open Flap debridement (OFD) surgery after conventional periodontal therapy
           (Scaling &Curettage and root planing) combined by Er,Cr:YSGG Laser assisted pocket
           therapy (ELAPT) which will be applied to pocket epithelial lining and root surface.

        2. Group (2) Open Flap debridement (OFD) surgery after conventional periodontal therapy
           (Scaling &Curettage and root planing) will be performed.
    

Intervention name(s): laser device Er,Cr:YSGG laser
Intervention type(s): Device
Intervention description(s): laser device with open flap debridement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Combined Spinal-epidural Versus Spinal Analgesia for Elective Caesarean Section in the Postoperative Period
Condition: Satisfaction; Pain
Study type: Observational

Summary: 
      Combined spinal epidural (CSEA) and single shot spinal anesthesia (SSSA) are both
      well-established anesthetic methods for caesarean section. CSEA combines the advantages of
      spinal anesthesia for the surgery, and epidural anesthesia for postoperative pain management.
      The aim of this randomized trial was to compare analgesia and patient satisfaction with CSEA
      continuous epidural administration of local anesthetics versus SSSA with oral pain medication
      in the postoperative period.
    

Detailed description: 
      Combined spinal epidural (CSEA) and single shot spinal anesthesia (SSSA) are both
      well-established anesthetic methods for caesarean section. CSEA combines the advantages of
      spinal anesthesia for the surgery, and epidural anesthesia for postoperative pain management.
      However, it is more time-consuming, and adds potentially risks of both single techniques.

      The aim of this randomized trial was to compare analgesia and patient satisfaction with CSEA
      continuous epidural administration of local anesthetics versus SSSA with oral pain medication
      in the postoperative period.
    

Intervention name(s): caesarean section
Intervention type(s): Procedure
Intervention description(s): elective caesarean section under regional anesthesia
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        healthy parturients scheduled for elective caesarean section
Zosuquidar in Combination With Daunorubicin and Cytarabine in Patients Ages 55-75 With Newly Diagnosed Acute Myeloid Leukemia (AML)
Condition: Leukemia, Myeloid
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Chemotherapy drugs use different ways to stop cancer cells from dividing so they stop growing
      or die. Zosuquidar may help daunorubicin and cytarabine kill more cancer cells by making
      cancer cells more sensitive to the drugs. It is not yet known whether daunorubicin and
      cytarabine are more effective with or without zosuquidar in treating acute myeloid leukemia.
    

Detailed description: 
      Purpose:

      Phase I:

      To Evaluate the safety of different doses of zosuquidar.

      Phase II:

      This study is designed to study the safety and effectiveness of zosuquidar when given with
      daunorubicin and cytarabine in newly diagnosed AML patients.
    

Intervention name(s): Zosuquidar; Daunorubicin; Cytarabine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Cytarabine; Daunorubicin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Leukemia, Myeloid; Relapse; Chemotherapy; Zosuquidar; Daunorubicin; Cytarabine; Acute; AML; Adult AML
Flu Vaccine Response in Patients on Biologic Therapies
Condition: Rheumatologic Disorder; Inflammatory Bowel Diseases; Immune Complex Diseases
MeSH terms: Rheumatic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Collagen Diseases; Immune Complex Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This proposed study will assess the immunogenicity, safety, and clinical efficacy of an
      influenza vaccine booster dose strategy in patients with autoimmune diseases who are
      receiving immunosuppressive therapies. Investigators will compare serologic responses to
      single versus a booster dose of influenza vaccine in patients with inflammatory bowel disease
      (IBD- Crohn's Disease or Ulcerative Colitis) or rheumatologic diseases who are receiving
      immunosuppressive therapies. Subjects will be randomized to receive either one or two doses
      of influenza vaccination in year #1. In year# 2, all participants will be given two doses of
      influenza vaccine. Serologic responses will be measured pre and 4-6 weeks post vaccination.
      This study will also assess the immunogenicity and safety of a booster vaccine strategy in
      the prevention of influenza-like illness (ILI). Investigators anticipate that booster dose
      strategy will improve both clinical and serologic responses in this vulnerable population.
    


Intervention name(s): Influenza vaccine
Intervention type(s): Biological
Intervention description(s): The primary aim of this study is to assess the immunogenicity of booster dose influenza vaccine strategy in patients with rheumatologic diseases and IBD who are receiving immunosuppressive therapies.
Secondary aims of this study include assessment of the safety and clinical efficacy, of booster dose influenza vaccine in the prevention of influenza-like illnesses (ILI) in this patient population
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza vaccine; Booster dose; immunocompromised; Biologic therapy; Rheumatologic disease; inflammatory bowel disease
Shock Wave Versus Iontophoresis in Treatment of Subjects With Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Both extra corporeal shock wave and dexamethasone iontophoresisare effective in treatment of
      knee osteoarthritis but which one is more effective is not clear yet . so the purpose of this
      study was to investigate and compare between the effect of shock wave and iontophoresis in
      treatment of knee osteoarthritis . it was hypothesized that there will be no difference
      between the effect of shock wave and iontophoresis on treatment of knee osteoarthritis.
    

Detailed description: 
      60 subjects with grade II knee osteoarthritis will be recruited from outpatient clinic of
      faculty of physical therapy and then they will be assigned randomly by sealed envelope into
      three groups ;group A (shock wave group) will received radial extracorporeal shock wave
      ,group B (Iontophoresis group ) will receive deaxamthasone iontophoresis and group c (control
      group) will receive traditional tratment ( stregnthening exerciseces) all treatment will be
      once session per week for four weeks .pain intensity ,knee ROM and knee injury and
      osteoarthritis outcome score physical function short (KOOS-PS).
    

Intervention name(s): radial extracorporeal shock wave; iontophoresis; Exercise
Intervention type(s): Device; Device; Other
Intervention description(s): Radial shock wave device, Swiss DolorClast (EMS Electro Medical Systems, Nyon, Switzerland); Iontophoretic drug delivery system (phoresors II auto model PM850 IOMED):; strengthening exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Single (Participant)
Primary purpose: Treatment
Aloe Vera in Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of the present study is to study the effect of aloe vera in the treatment of IBS
      patients in a randomized, double-blind placebo controlled study.
    

Detailed description: 
      There is limited knowledge of the IBS pathophysiology, absence of biological markers and
      therefore few effective treatment options. IBS therefore contributes to difficulties in the
      management of the patients. Aloe vera has a long association with herbal medicine, from the
      Ebers Papyrus from 16th century BCE. It is alleged to be effective in treatment of wounds, to
      improve blood glucose levels in diabetics, and it may reduce symptoms and inflammation in
      patients with ulcerative colitis. Evidence of the effects of aloe vera in the treatment of
      IBS, is however limited and contradictory.
    

Intervention name(s): Aloe vera effervescent tablet (AVH200); Placebo control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 250 mg aloe vera and 60 mg ascorbic acid, Aloe Life®; 60mg Ascorbic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
PF-00489791 For The Treatment Of Raynaud's
Condition: Raynaud's Disease; Peripheral Vascular Disease
MeSH terms: Vascular Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease; Raynaud Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators propose that once daily administration of PF-00489791, a phosphodiesterase
      inhibitor, will reduce vasospasm and improve symptoms and signs associated with Primary and
      Secondary Raynaud's Phenomenon.
    


Intervention name(s): PF-00489791; PF-00489791; PF-00489791; PF-00489791; PF-00489791; PF-00489791; PF-00489791; PF-00489791
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subjects with Secondary Raynaud's Phenomenon will receive PF-00489791 4 mg once a day for the first 4 week cross over period and then placebo once a day for the second 4 week cross over period; Subjects with Secondary Raynaud's Phenomenon will receive placebo once a day for the first 4 week cross over period and then PF-00489791 4 mg once a day for the second 4 week cross over period; Subjects with Secondary Raynaud's Phenomenon will receive PF-00489791 20 mg once a day for the first 4 week cross over period and then placebo once a day for the second 4 week cross over period; Subjects with Secondary Raynaud's Phenomenon will receive placebo once a day for the first 4 week cross over period and then PF-00489791 20 mg once a day for the second 4 week cross over period; Subjects with Primary Raynaud's Phenomenon will receive PF-00489791 4 mg once a day for the first 4 week cross over period and then placebo once a day for the second 4 week cross over period; Subjects with Primary Raynaud's Phenomenon will receive placebo once a day for the first 4 week cross over period and then PF-00489791 4 mg once a day for the second 4 week cross over period; Subjects with Primary Raynaud's Phenomenon will receive PF-00489791 20 mg once a day for the first 4 week cross over period and then placebo once a day for the second 4 week cross over period; Subjects with Primary Raynaud's Phenomenon will receive placebo once a day for the first 4 week cross over period and then PF-00489791 20 mg once a day for the second 4 week cross over period
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Raynaud's phenomenon; vasospasm; scleroderma; systemic sclerosis; CREST; phosphodiesterase inhibitor
Study in Infants (6-12 Months) Comparing Two Doses of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Vaccine Versus a Tetanus Toxoid-Conjugated Vaccine Available for the Prevention of Haemophilus Influenzae Type b Infections in China
Condition: Haemophilus Influenzae Type b (Hib) Infection
MeSH terms: Infections; Influenza, Human; Tetanus; Diphtheria
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety and efficacy of two doses of two commercially available
      vaccines used to prevent Haemophilus influenzae type b infections in children 6-12 months of
      age.
    


Intervention name(s): Haemophilus influenzae type b (Hib) vaccine
Intervention type(s): Biological
Intervention description(s): Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines - a monovalent glycoprotein-conjugated (diptheria toxin - CRM197) vaccine and a tetanus toxoid-conjugated vaccine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Haemophilus influenzae type b (Hib); Vaccine; Booster
Stroke and Assessment of Muscle Tone
Condition: Stroke; Muscle Tone Abnormalities; Pain; Muscle Spasticity
MeSH terms: Muscle Spasticity; Stroke
Study type: Observational

Summary: 
      Spasticity is defined as a state of increased muscle tone, which evokes an increased
      resistance to a passive and fast stretching of the muscle. Indeed, the degree of spasticity
      depends, among other things, on the stretching velocity performed to the muscle. However,
      most of the tools used in the clinical setting to assess spasticity do not take into account
      the relationship between increased muscle tone and speed of stretching. Instead of that,
      muscle tone is usually assessed in a relaxed position of the muscle.

      Likewise, to date, despite the functional disabilities related to the presence of chronic
      pain after a stroke, no previous study has correlated muscle tone and pressure pain
      sensitivity within this population
    


Intervention name(s): Assessment of Tone, Pain and Thickness
Intervention type(s): Diagnostic Test
Intervention description(s): Evaluation of Muscle state of tension, self-reported response to mechanical pressure pain and muscle thickness. The evaluation process of muscle tone and pressure pain sensitivity will be carried out following a topographical mapping covering myotendinous and muscle belly sites in the biceps brachii and the gastrocnemius muscles
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants with acute or chronic stroke will be recruited from large public hospitals.
        The control participants will be selected from the same population-based cohort
      
Keywords: Topographical mapping; Muscle state of tension; Myotonometer; Pressure Pain Threshold; Muscle Thickness
Pharmacokinetic Analysis of Midazolam and Fentanyl in Pediatric Patients With Long-term Analgosedation
Condition: Deep Sedation; Intensive Care Pediatric
Study type: Observational

Summary: 
      Pharmacokinetic monitoring of midazolam, it's active metabolite and fentanyl in pediatric
      patients with long-term analgosedation will be performed. Especially, the chronologic
      sequence of the quantified plasma levels during sedation and during wake-up as well as the
      correlation to dose and sedation depth will be focused.
    

Detailed description: 
      At pre-defined timepoints (see below) serum Levels of the above mentioned drugs and
      metabolites will be determined and pharmakokinetic (PK) modeling will be performed. PK data
      will be correlated to sedation depth, as assessed using a validated score.

      Three Age Groups (infants, children and adolescents) will be evaluated considering the
      physiologic properties during pediatric development.
    

Intervention name(s): PK analysis
Intervention type(s): Other
Intervention description(s): Quantification of Serum Levels and subsequent pharmacokinetic (PK) modelling.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pediatric patients with long-term analgosedation at the Pediatric Intensive Care Unit of
        the University Medical Center Hamburg-Eppendorf.
Quality of Nursing Care During The Covid-19 Pandemic
Condition: COVID-19 Pandemic; Children, Only; Hospitalism; Nurse's Role; Feelings
MeSH terms: COVID-19
Study type: Observational

Summary: 
      Enabling school-age children to evaluate the care they receive provides feedback on the
      quality of care by determining children's satisfaction with care, and gives important
      feedback on the quantity and quality of care. Evaluation of nursing care, emotions and
      behaviors from the perspective of children during the Covid-19 pandemic process will guide
      the improvement of the quality of care. As a result of the literature review on this subject,
      no research has been found, and it is thought that this research will contribute to the
      field. This research was conducted to evaluate nursing care and emotions from the perspective
      of hospitalized children during the Covid-19 pandemic process.
    


Intervention name(s): descriptive
Intervention type(s): Other
Intervention description(s): This research was conducted to evaluate nursing care from the perspective of hospitalized children during the Covid-19 pandemic process and to determine their feelings during this process.
Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        This cross-sectional descriptive study was conducted in a hospital in the Black Sea Region
        of XXX between February and June 2021