bioihbjkbjnl/mcl2 huggingface dataset:
Correlation Between Daily Physical Activity and Disability, Fatigue, Cognition and Quality of Life in MS Patients
Condition: Relapsing Remitting Multiple Sclerosis; Fatigue; Quality of Life; Physical Activity
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Fatigue
Study type: Observational

Summary: 
      The main purpose of the study is to assess the fatigue, cognition, quality of life and
      disability correlation to MS-patients daily physical activity.
    


Intervention name(s): Physical Activity measurement:
Intervention type(s): Device
Intervention description(s): 7 days measurement with Active style Pro HJA-350IT device
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient group: RRMS patients (18-55 years old)

        Control group: Healthy volunteers (18-55 years old)
Efficacy, Safety and Pharmacokinetics of Sugammadex (Org 25969; MK-8616) at 3 Different Time Points After 0.6 mg/kg Esmeron® in Male Participants (P05940; MK-8616-020).
Condition: Neuromuscular Blockade
Study type: Interventional
Phase: Phase 2

Summary: 
      This study investigates the efficacy, safety, and pharmacokinetics of sugammadex (Org 25969;
      MK-8616) when administered for the reversal of neuromuscular blockade in male participants
      receiving surgery, classified as American Society of Anesthesiologists (ASA) class 1
      (otherwise normal, healthy participant) to class 2 (participant with mild systemic disease).
      The primary objective of this study is to explore the dose-response relation of sugammadex
      given as a reversal agent at 3, 5, or 15 minutes following administration of 0.6 mg/kg
      Esmeron®.
    


Intervention name(s): Placebo; Sugammadex; Esmeron®
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.9% NaCl administered as a fast IV bolus dose (within 30 seconds).; Sugammadex administered as a fast IV bolus dose (within 30 seconds), dosed according to participant actual body weight.; Esmeron® administered at 0.6 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.
Other intervention name(s): Org 25969; MK-8616; Bridion®.; Rocuronium bromide
Intervention MeSH terms: Bromides; Rocuronium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of YPEG-Filgrastim in Chemotherapy Patients
Condition: Chemotherapy Patients
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics of a
      single-dose of YPEG-Filgrastim in cancer patients receiving chemotherapy, and will establish
      dose-response relationships between YPEG-Filgrastim and Filgrastim(rhG-CSF, TOPNEUTER).
    


Intervention name(s): YPEG-Filgrastim; YPEG-Filgrastim; YPEG-Filgrastim; YPEG-Filgrastim; YPEG-Filgrastim
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): s.c, single dose of 10mcg/kg of YPEG-Filgrastim at 48hr of cycle 2, followed by daily s.c either 2.5 mcg/kg or 5 mcg/kg of filgrastim(TOPNEUTER) starting from 48hr of cycle 3 until WBC≥10,000 per cubic milliliter or ANC≥5,000 per cubic milliliter in two continuous daily tests after ANC nadir.; s.c, single dose of 20mcg/kg of YPEG-Filgrastim at 48hr of cycle 2, followed by daily s.c either 2.5 mcg/kg or 5 mcg/kg of filgrastim(TOPNEUTER) starting from 48hr of cycle 3 until WBC≥10,000 per cubic milliliter or ANC≥5,000 per cubic milliliter in two continuous daily tests after ANC nadir.; s.c, single dose of 30mcg/kg of YPEG-Filgrastim at 48hr of cycle 2, followed by daily s.c either 2.5 mcg/kg or 5 mcg/kg of filgrastim(TOPNEUTER) starting from 48hr of cycle 3 until WBC≥10,000 per cubic milliliter or ANC≥5,000 per cubic milliliter in two continuous daily tests after ANC nadir.; s.c, single dose of 45mcg/kg of YPEG-Filgrastim at 48hr of cycle 2, followed by daily s.c either 2.5 mcg/kg or 5 mcg/kg of filgrastim(TOPNEUTER) starting from 48hr of cycle 3 until WBC≥10,000 per cubic milliliter or ANC≥5,000 per cubic milliliter in two continuous daily tests after ANC nadir; s.c, single dose of 60mcg/kg of YPEG-Filgrastim at 48hr of cycle 2, followed by daily s.c either 2.5 mcg/kg or 5 mcg/kg of filgrastim(TOPNEUTER) starting from 48hr of cycle 3 until WBC≥10,000 per cubic milliliter or ANC≥5,000 per cubic milliliter in two continuous daily tests after ANC nadir.
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: cancer patient; chemotherapy; carboplatin; taxol; cyclophosphamide; pharmorubicin
Minimal Access Repair of Contralateral Hernias (MARCH Trial)
Condition: Unilateral Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      Repair of unilateral inguinal hernia in infants. Laparoscopic repair, with closure of
      contralateral patent processus vaginalis if present, versus open repair
    


Intervention name(s): Repair of unilateral inguinal hernia
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Carbon Dioxide Infusion:Clinical and Histological Appraisal in Chronic Wounds
Condition: Wounds
MeSH terms: Wounds and Injuries
Study type: Observational

Summary: 
      Carbon dioxide infusion is a non surgical procedure applied via percutaneous, transdermal and
      subcutaneous. Increase in the concentration of carbon dioxide decreases pH activating local
      nitric oxide that stimulates collateral vessels formation, vascular endothelial growth factor
      and basic fibroblast growth factor. Carbon dioxide infusion restores the blood flow in
      chronic wounds of the lower limbs.
    

Detailed description: 
      Ten patients with chronic wounds caused by venous insufficiency at both lower limbs were
      distributed into groups. Group I was composed by wounds in the right lower limb that received
      carbon dioxide and group II by wounds in the left lower limb that not received carbon
      dioxide, both related to the same patient. Carbon dioxide infusion was performed with the
      needle pointed toward the granulation tissue, 5cm distant from each one at intervals of 4
      days. Biopsies were collected from the wounds before carbon dioxide infusion and after the
      3rd, 5th and 10th application. Statistical analysis of the data was performed using
      Wilcoxon's test and Friedman's variance analysis and multiple comparisons test.
    

Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        10 patients with chronic wounds on both lower limbs
      
Keywords: carbon dioxide infusion; dilatation of peripheral blood vessels; capillaries; macrophags; fibroblasts; Improvement granulation tissue in chronic wounds
Analysis of the Incidence of Post-Operative Wound Infections After Spine Surgery
Condition: Infection
MeSH terms: Infections; Communicable Diseases; Wound Infection; Surgical Wound Infection; Surgical Wound
Study type: Observational

Summary: 
      Post-operative wound infections can prolong hospital stays, increase rates of readmission to
      the intensive care unit, and increase the costs of treatment significantly. This study will
      conduct a prospective chart review of all patients undergoing elective spinal surgery on both
      the neurosurgery and orthopedic spine services at two facilities on an academic campus. The
      investigators will collect the data of those patients who develop post-surgical infections.
      This data will then be analyzed and compared to published data from other studies. The aim of
      this investigation is to passively collect this infection data, which may ultimately provide
      needed baseline incidence rates using current and standard protocols.
    

Detailed description: 
      This is a chart review study.
    

Intervention name(s): Spinal surgery
Intervention type(s): Procedure
Intervention description(s): Elective spinal surgery performed
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients 18 years of age or older undergoing a spinal operation.
      
Keywords: spinal surgery, surgical site infection
The Study of Safety, Pharmacokinetics, Pharmacodynamics of Peglamda (Peginterferon Lamda 1) on Healthy Volunteers and the Preliminary Evaluation of Peglamda and Hepasig (Ribavirin) Treatment's Effects on Chronic Hepatitis C Patients
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, dose ranging, phase1a/1b clinical trial to study the safety,
      Pharmacokinetics and Pharmacodynamics of Peglamda 60, 120, 180 and 240 mcg in healthy
      volunteers and antiviral activity of once weekly Peglamda administration in combination with
      daily Ribavirin in Hepatitis C naive patients up to 4 weeks period. The objective of the
      study to establish safety, PK/PD data on healthy subjects and preliminary efficacy and safety
      in Hepatitis C naive patients.
    


Intervention name(s): Peginterferon lambda
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C naive
Trial of Hypofractionated Radiation Therapy for Glioblastoma
Condition: Glioblastoma
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being done to compare standard radiation therapy with hypofractionated
      radiation therapy for patients with newly diagnosed glioblastoma
    

Detailed description: 
      Hypofractionated radiation therapy (RT) in the treatment of patients with glioblastoma, 18 -
      70 years of age with good performance status (ECOG 0 - 2), will be well tolerated and yield
      survival non-inferior to conventional fractioned RT, allowing significant abbreviation of the
      length of the radiation course required for these patients with limited survival. The
      importance of hypofractionation is, therefore, not in improving survival, but rather to
      shorten RT duration to improve patient comfort and convenience. This approach is pertinent
      given the limited life expectancy of glioblastoma and has been used in patients with
      prolonged survival including breast and prostate cancers.
    

Intervention name(s): Hypofractionated radiation therapy; Standard radiation therapy
Intervention type(s): Radiation; Radiation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 1:1, randomized, open label
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: glioblastoma; radiotherapy; hypofractionated radiotherapy
Brain Imaging To Examine The Effect Of Naproxen In Hand Osteoarthritis Patients
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The study hypothesis is that the relief of pain in patients with osteoarthritis in the hand
      can be detected by a form of brain scanning that detects which parts of the brain are
      activated when pain is felt.
    


Intervention name(s): Naproxen; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 500 mg BID 7 days; BID 7 days
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: fMRI functional magnetic resonance imaging Pain
A Clinical Pharmacology Study of Saxagliptin in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamics of
      saxagliptin administered before breakfast for 14 consecutive days in patients with type 2
      diabetes mellitus.
    


Intervention name(s): saxaglipitin
Intervention type(s): Drug
Intervention description(s): oral administration of 5 mg tablet before breakfast for 14 consecutive days
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Diabetes, Type 2
The Effects of ∆-9-THC and Naloxone in Humans
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this project is to examine the effects of mu-opiate antagonism on the
      rewarding and reinforcing effects of delta-9-tetrahydrocannabinol (THC), the main
      psychoactive ingredient of cannabis.
    


Intervention name(s): Naloxone; Delta-9-THC; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Active Naloxone 18 mcg/kg intravenously over 60 minutes, 2mg IV push, 1mg IV push; Active Delta-9-THC (0.025mg/Kg) given intravenously over 20 minutes.; Placebo
Intervention MeSH terms: Dronabinol; Naloxone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Cannabis; Marijuana; Naloxone; THC; Psychotic Disorders
Assessment of Safety, Tolerability, Immunogenicity, and Pharmacokinetics of AZD3427
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      This first-time-in-human (FTIH) study will be conducted to evaluate the safety, tolerability,
      pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of single doses of AZD3427
      in healthy volunteers and multiple doses of AZD3427 in patients with heart failure (HF).
    

Detailed description: 
      This is a multi-center single and multiple ascending dose study (SAD and MAD).

      Part A (SAD) will include 7 cohorts (8 healthy volunteers in each cohort) and will randomize
      to AZD3427 or placebo, in a 6:2 ratio. One cohort will entirely include participants of
      Japanese descent.

      Part B (MAD) will include 6 cohorts (8 heart failure patients in each cohort) and will
      randomize to AZD3427 or placebo in a 6:2 ratio. Of these, 3 cohorts will contain participants
      with heart failure with reduced ejection fraction [HFrEF] and the other 3 cohorts will
      comprise of participants with heart failure with HF with ejection fraction (EF) ≥ 41%. There
      will be a maximum screening period of 27 days. Participants in part A and B will undergo
      study drug administration on Day 1. In addition, participants in part B will return for 4
      additional doses on Days 8, 15, 22, and 29. Participants will be followed for at least 50
      days after the last dose of study drug.
    

Intervention name(s): AZD3427; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive SC or IV dose of AZD3427 as per the arm they are randomized.; Participants will receive SC or IV dose of placebo matched to AZD3427 as per the arm they are randomized.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Heart failure with reduced ejection fraction; Heart failure with ejection fraction of ≥ 41%; AZD3427; First-time-in-human
Value of CA125 and Yolk Sac Morphology in Prediction of Pregnancy Outcome in Threatened Miscarriage
Condition: Threatened Miscarriage in First Trimester
MeSH terms: Abortion, Spontaneous; Abortion, Threatened
Study type: Observational

Summary: 
      evaluation of serum CA125 level and yolk sac morphology in women with threatened miscarriage
      is very important to predict pregnancy outcome
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pregnant women at age of 20- 40 years Pregnancy at 6-10 weeks women with single
        intrauterine spontaneous pregnancy
      
Keywords: CA125; Yolk sac morphology; Threatened miscarriage
A Study Evaluating the Safety of Cal-1 (LVsh5/C46) Drug Product in HIV-1 Infected Patient With High Risk Lymphoma
Condition: HIV-1 Infection
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and the feasibility, and the success of
      engraftment of the introduction of Cal-1 gene-transduced haematopoietic cell populations (Ttn
      and HSPCtn) in patients with HIV-1-related high-risk lymphoma.
    

Detailed description: 
      not provided
    

Intervention name(s): Cal-1 (LVsh5/C46) drug product
Intervention type(s): Drug
Intervention description(s): Autologous CD34+ Haematopoietic Stem/Progenitor Cells and CD4+ T Lymphocytes Transduced with LVsh5/C46, a Dual Anti-HIV Gene Transfer Construct
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV-1; Lymphoma; Gene therapy
Evaluating a Pharmacokinetic Drug Interaction Between LGEV1801 and LGEV1802
Condition: Healthy Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the drug-drug interaction between LGEV1801 and
      LGEV1802 in healthy male volunteers.
    


Intervention name(s): Valsartan; Ezetimibe/Rosuvastatin
Intervention type(s): Drug; Drug
Intervention description(s): Valsartan P.O; Ezetimibe/Rosuvastatin P.O
Other intervention name(s): Diovan; Rosuzet
Intervention MeSH terms: Valsartan; Rosuvastatin Calcium; Ezetimibe
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase I Study to Compare NP101(Sumatriptan Iontophoretic Transdermal Patch) With Three Formulations of Imitrex®
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to compare the pharmacokinetics (PK) of NP101 with the currently
      approved oral, injection and nasal spray formulations of Imitrex® in healthy volunteers and
      to assess the bioavailability relative to the 6 mg subcutaneous injection.

      The secondary objective is to evaluate the safety of NP101 in healthy volunteers.
    


Intervention name(s): Sumatriptan succinate; Sumatriptan succinate
Intervention type(s): Drug; Drug
Intervention description(s): NP101 iontophoretic transdermal system; oral, subcutaneous, and intranasal formulations
Intervention MeSH terms: Sumatriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Focus of study is to compare pharmacokinetics
Active Video Games to Promote Physical Activity in Children With Cancer
Condition: Cancer
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the efficacy and feasibility of active video gaming with
      regard to the promotion of physical activity and motor learning in children with cancer.
      Experienced fatigue, body mass index and the development of metabolic risk factors during
      treatment are also examined.
    


Intervention name(s): Exercise based on active video gaming
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Bioequivalency Study of Torsemide Tablets Under Fed Conditions
Condition: Edema
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The objective of this study was the bioequivalence of a Roxane Laboratories' Torsemide
      Tablets, 20 mg, to Demadex® Tablets, 20 mg (Roche) under fed conditions using a single-dose,
      2-treatment, 2-period, crossover design.
    


Intervention name(s): Torsemide
Intervention type(s): Drug
Intervention MeSH terms: Torsemide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effectiveness of Music on Pain During Heel Blood Collection in Premature Infants
Condition: Pain
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Premature babies receiving treatment and care in the Neonatal Intensive Care Unit (NICU) are
      exposed to various painful procedures. Repetitive and untreated painful procedures have a
      negative impact on the physiological, cognitive and behavioral development of the baby.

      Various approaches such as white noise, music, lullaby, kangaroo care, breastfeeding,
      swaddling, massage, and therapeutic positioning are used to reduce the painful processes that
      newborns are exposed to in the NICU.
    

Detailed description: 
      Premature babies receiving treatment and care in the Neonatal Intensive Care Unit (NICU) are
      exposed to various painful procedures. Repetitive and untreated painful procedures have a
      negative impact on the physiological, cognitive and behavioral development of the baby.

      Various approaches such as white noise, music, lullaby, kangaroo care, breastfeeding,
      swaddling, massage, and therapeutic positioning are used to reduce the painful processes that
      newborns are exposed to in the NICU.
    

Intervention name(s): Music; Music
Intervention type(s): Other; Other
Intervention description(s): Intervention-1 group will listen to the classical music that the "Arts of Fugue" by Bach.; Intervention-2 group will listen to lullaby.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Premature; Pain; Music
Effects of Birth Weight on Anterior Eye Segment Measurements in Full-Term Children by Galilei Dual-Scheimpflug Analyzer
Condition: Birth Weight
MeSH terms: Body Weight; Birth Weight
Study type: Observational [Patient Registry]

Summary: 
      This study evaluates the effects of birth weight (BW) on ocular anterior segment parameters
      in preschool children using the Galilei Dual-Sheimpflug Analyzer (GD-SA). Children were
      measured by GD-SA and relationships between all anterior segment parameters obtained by this
      device and birth weight were analyzed.
    

Detailed description: 
      Preschoolers, who were born heavier, had thicker cornea and lens, longer axial length, and
      flatter corneal curve. The thicknesses and axial curves of central cornea within 7mm may be
      particularly associated with BW.
    

Intervention name(s): Galilei Dual-Scheimpflug Analyzer
Intervention type(s): Device
Intervention description(s): Measuring of Anterior Segment by Galilei Dual-Scheimpflug Analyzer
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy children aged between 3-6- preschoolers- born at term and have birth weight heavier
        than 2500g
Real World CCH Study in Adult Females With Cellulite
Condition: Edematous Fibrosclerotic Panniculopathy (EFP); Cellulite
MeSH terms: Cellulite
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, open-label, multiple dose, 2 cohort, Phase 3b study to assess the
      safety and efficacy of CCH in adult women with mild or moderate edematous fibrosclerotic
      panniculopathy (EFP).

      Cohort 1 will include approximately 80 subjects with mild or moderate EFP in the
      posterolateral thighs and Cohort 2 will include approximately 70 subjects with mild or
      moderate EFP in the buttocks.
    


Intervention name(s): EN3835
Intervention type(s): Drug
Intervention description(s): Collagenase Clostridium Histolyticum (CCH)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment