bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Physical Activity Tele-Counseling Intervention in Post-COVID-19 Conditions
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      It has been found that physical activity recommendations with telerehabilitation in different
      disease groups improve the functional capacity, physical activities and mental health of the
      patients as much as the supervised exercise programs. However, there are no studies in the
      literature that provide online physical activity counseling in COVID-19 patients, and
      evaluate the effect of physical activity counseling on physical activity level, quality of
      life, physical performance, fatigue, kinesophobia, pain, dyspnea, mental health and behavior
      change levels. For this reason, this study aimed to evaluate the effect of online physical
      activity counseling on physical activity level, quality of life, physical performance,
      fatigue, kinesophobia, pain, dyspnea, mental health and behavior change level in COVID-19
      patients.
    


Intervention name(s): Physical activity counseling
Intervention type(s): Behavioral
Intervention description(s): Physical activity counseling will be performed using physical activity behavior steps of the transtheoretical model.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
VASCADE ANTEGRADE-PVD Post-Market Registry
Condition: Surgical Wound
MeSH terms: Surgical Wound
Study type: Observational [Patient Registry]

Summary: 
      The objective of the registry is to collect procedural outcomes data when the Cardiva VASCADE
      Vascular Closure System (VCS) is used to seal femoral arterial access sites at the completion
      of ipsilateral peripheral interventional procedures performed through 5-7F introducer sheaths
      via an antegrade approach.
    

Detailed description: 
      Due to the growing adoption of antegrade femoral access and the use of VCDs to close these
      arteriotomies, it is important to collect performance and complication outcomes data related
      to this procedural variable. The aim of this registry is to consistently collect prospective
      data on procedural outcomes on antegrade access cases closed with the VASCADE VCS in a way
      that is consistent with the RESPECT Study design and the FDA-approved Instructions for Use
      (IFU).
    

Intervention name(s): Cardiva Medical VASCADE VCS
Intervention type(s): Device
Intervention description(s): At the end of peripheral endovascular interventional procedures performed via an antegrade femoral arterial approach, the femoral arterial access site is closed with the VASCADE VCS to achieve arterial hemostasis.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Acceptable candidate for an elective, non-emergent ipsilateral peripheral interventional
        endovascular procedure via antegrade access of the femoral artery using a 5, 6 or 7 Fr
        introducer sheath
      
Keywords: Vessel closure; Antegrade access; Femoral arteriotomy; Peripheral endovascular interventions
Quality of Ventilation With Facial Versus Nasal Mask vs Nasal Mask Anesthesia in Children 3 to 12 Years Old
Condition: Ventilation; Intubation Complication; Intubation; Difficult or Failed
Study type: Interventional

Summary: 
      In this single-blind clinical trial study, 70children who are candidates for lower abdominal
      elective surgery under general anesthesia presented at Imam Hossein Hospital in Isfahan will
      be included in the study and will be divided into 2 groups. In the first group, ventilation
      with facial mask and in the second group, ventilation with nasal mask will be done for three
      minutes. Then the reduction in SPO2 and the impossibility of ventilation of patients will be
      evaluated and compared between the two groups.
    


Intervention name(s): Ventilation
Intervention type(s): Device
Intervention description(s): Patients in group 1 undergo ventilation with an anatomical facial mask and 100% oxygen for three minutes. Patients in group 2 undergo ventilation with a nasal mask and 100% oxygen for three minutes. In both groups, ventilation will be performed with the controlled mode of the anesthesia machine with a volume of 8 cc/kg and a speed of 12-20/min.
Other intervention name(s): Mask
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
The Effect of Lamina-G on Gastrointestinal Symptom After Gastric Biopsy
Condition: Gastrointestinal Symptom
Study type: Interventional
Phase: Phase 4

Summary: 
      Sometimes, subjects complain about gastrointestinal symptoms after esophagogastroduodenoscopy
      and biopsy. The aim of this study is to investigate the effect of sodium alginate (Lamina-G®)
      on biopsy-related gastrointestinal symptom.
    

Detailed description: 
      This study is an open labeled, single-center randomized controlled trials. Patients who
      underwent upper enoscopy with biopsy were randomly assigned to medication and control group.
      In the medication group, sodium alginate was administered after EGD during 3 days. All
      patients underwent a questionnaire to check the presence of gastrointestinal symptoms at
      baseline and on the day after return home. After 3 days, gastrointestinal symptoms were
      investigated by telephone survey. Gastrointestinal symptom was scaled by upper
      gastrointestinal symptom rate score (GSRS). Upper GSRS contains 8 items and 3 scales;
      abdominal pain (abdominal pain, epigastric pain/hunger soreness, nausea), reflux symptom
      (Heartburn/reflux/belching gas), indigestion symptom (abdominal distension, borborygmus).
    

Intervention name(s): Sodium alginate
Intervention type(s): Drug
Intervention description(s): 3 days oral administration of sodium alginate after gastric biopsy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: open labeled, single-center randomized controlled trial
Masking: None (Open Label)
Primary purpose: Prevention
High Tibial Osteotomy for Osteoarthritis of the Knee
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      A prospective, randomised, controlled trial compared two different techniques of high tibial
      osteotomy with a lateral closing wedge or a medial opening wedge, stabilised by a Puddu
      plate. The clinical outcome and radiological results were examined at one year.
    

Detailed description: 
      A prospective, randomised, controlled trial compared two different techniques of high tibial
      osteotomy with a lateral closing wedge or a medial opening wedge, stabilised by a Puddu
      plate. The clinical outcome and radiological results were examined at one year.

      The primary outcome measure was the achievement of an overcorrection of valgus of 4°.
      Secondary outcome measures were the severity of pain (visual analogue scale), knee function
      (Hospital for Special Surgery score), and walking distance.
    

Intervention name(s): Opening-wedge HTO; Closing-wedge HTO
Intervention type(s): Procedure; Procedure
Intervention description(s): Opening-wedge high tibial osteotomy fixated with a Puddu plate; Closing-wedge high tibial osteotomy fixated with two staples
Other intervention name(s): open wedge high tibial osteotomy; Closed wedge high tibial osteotomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Safety and Tolerability Study in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Condition: Idiopathic Pulmonary Fibrosis; IPF
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, placebo-controlled, double-blind, 6-month study followed by a 6 month
      open-label extension phase to evaluate the efficacy, safety, and tolerability of MN-001 in
      moderate to severe IPF patients. MN-001 750 mg or matching placebo will be orally
      administered twice daily over a 26 week period in subjects with a confirmed diagnosis of IPF
      per the ATS )American Thoracic Society) 2011 Guidelines. Approximately 15 subjects are
      planned to be enrolled. This study will consist of two treatment arms, MN-001 and matching
      placebo. Randomization will occur in a 2:1 ratio (MN-001: placebo). Eligible subjects will
      consist of males and females ranging in age from 21 to 80 years old, inclusive.

      The study will consist of a Screening Phase (up to 3 months prior to Day1) followed by a 26
      week double-blind Treatment Phase, a 26 week Open-Label Extension (OLE) phase and a Follow-up
      Visit (within 4 weeks after the last dose).
    


Intervention name(s): tipelukast; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A novel, orally bioavailable small molecule compound that demonstrates anti-inflammatory and anti-fibrotic activity; Excipients of MN-001/tipelukast
Other intervention name(s): MN-001
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tipelukast; IPF; fibrosis; Idiopathic Pulmonary Fibrosis
A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-Deoxythymidine (Stavudine; d4T) in Children With HIV Infection
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      PRIMARY: To compare the relative safety and tolerance of oral zidovudine (AZT) versus oral
      stavudine (d4T) in symptomatic HIV-infected children.

      SECONDARY: To compare the clinical, virologic, and immunologic responses between the two
      treatment groups, and to obtain pharmacokinetic data for both drugs.

      At present, AZT is considered the drug of choice for initial treatment of most children with
      HIV infection, although disease progression or drug intolerance is associated with its
      long-term use. In preliminary studies in children, d4T, another HIV inhibitor, has been well
      tolerated, although an optimum dose has not been determined.
    

Detailed description: 
      At present, AZT is considered the drug of choice for initial treatment of most children with
      HIV infection, although disease progression or drug intolerance is associated with its
      long-term use. In preliminary studies in children, d4T, another HIV inhibitor, has been well
      tolerated, although an optimum dose has not been determined.

      Patients are randomized to receive either oral AZT or oral d4T. Treatment continues until the
      last patient enrolled has received 52 weeks of therapy, or until the study is terminated.
    

Intervention name(s): Stavudine; Zidovudine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Zidovudine; Stavudine
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Zidovudine; Stavudine
The Influence of Febuxostat on Coronary Artery Endothelial Dysfunction in Participants With Chronic Stable Angina
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Angina, Stable
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the effect of febuxostat on coronary artery flow in
      patients with coronary artery disease.
    

Detailed description: 
      The drug being tested in this study is called febuxostat. Febuxostat is being tested to treat
      people who have angina. This study will look at the heart and blood flow of people who take
      febuxostat.

      The study will enroll approximately 30 patients. Participants will be randomly assigned (by
      chance, like flipping a coin) to one of the two treatment groups (or sequences)-which will
      remain undisclosed to the patient and study doctor during the study (unless there is an
      urgent medical need):

        -  Sequence 1: 6 weeks febuxostat followed by 6 weeks of placebo.

        -  Sequence 2: 6 week placebo followed by 6 weeks of febuxostat

      All participants will be asked to take one capsule at the same time each day throughout the
      study. All participants will be asked to record any time they have angina symptoms during the
      study.

      This single-center trial will be conducted in the United States. The overall time to
      participate in this study is 16 weeks. Participants will make 7 visits to the clinic
      including a final visit 4 weeks after last dose of study drug for a follow-up assessment.
    

Intervention name(s): Febuxostat; Febuxostat placebo
Intervention type(s): Drug; Drug
Intervention description(s): Febuxostat capsules; Febuxostat placebo-matching capsules
Intervention MeSH terms: Febuxostat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Drug therapy
Potential Role of Donor-derived Cell-Free DNA as a Biomarker in Cardiac Allograft Vasculopathy
Condition: Cardiac Allograft Vasculopathy
MeSH terms: Vascular Diseases
Study type: Observational

Summary: 
      Cross-sectional study. We will prospectively obtain ddcf-DNA levels in all patients who
      undergo routine coronary angiography > 1 year after HT. Our main goal is to evaluate the
      performance of Donor-derived Cell Free DNA (ddcf-DNA) as a biomarker of CAV.
    


Intervention name(s): Donor-derived Cell Free DNA
Intervention type(s): Diagnostic Test
Intervention description(s): We will compare ddcfDNA with coronary angiogram determined CAV grading, according to ISHTL2010 classification
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Heart Transplant recipients that undergo routine surveillance coronary angiogram
      
Keywords: Donor-derived Cell Free DNA; Heart Transplant
NAFLD: Independent Effects of Western Dietary Pattern Profile and Sedentary Life
Condition: Fatty Liver
MeSH terms: Fatty Liver
Study type: Interventional

Summary: 
      Investigators perform a counseling intervention study (6 months) in adult subjects with
      evidence of Fatty Liver by Ultrasound, graded 0-3 according to the Bright Liver Score (BLS);
      exclusion criteria are diabetes, renal insufficiency (glomerular filtration rate < 90
      ml/min), cancer, heart failure > II NYHA ( New York Heart Association) Class), chronic virus
      hepatitis, and cirrhosis. Insulin resistance was assessed as homeostasis model
      assessment-insulin resistance (HOMA-IR) . Suggestions and advice on individual "healthy" food
      purchase, storage, and cooking were given. Reliable feedback and evidence of patients'
      adherence were obtained by scheduled dietician's interviews. Investigators will challenge the
      predictive effects of the Adherence to Mediterranean Diet, of Western dietary profile score
      and of increased physical activity at 6 months in a body mass index changes-balanced model to
      detect independent effects, if any, of the studied variable on NAFLD persistence,
      amelioration or disappearance. Threshold and odds of Mediterranean and Western dietary
      profile score will be calculated by contingency tables and receiver operator characteristic
      curve (ROC) analysis..
    

Detailed description: 
      Dietary and physical exercise counseling.
    

Intervention name(s): diet
Intervention type(s): Behavioral
Intervention description(s): diet
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Low Level Laser Therapy for Treatment of Tinnitus in Red Sea Scuba Divers
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional

Summary: 
      Scuba Diving has become a popular hobby, for a leisure activity, diving puts the auditory
      system at the risk of a wide variety of complaints including tinnitus, Low level laser
      therapy is a new modality in treatment of tinnitus. This study evaluates effect of laser
      therapy on tinnitus of Scuba divers in Red Sea.
    


Intervention name(s): Low level laser therapy; Sham device
Intervention type(s): Device; Other
Intervention description(s): Low level laser therapy from suitable machine; The device wasn't working
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Orange Juice Consumption and Cognitive Function
Condition: Nerve Degeneration
MeSH terms: Nerve Degeneration
Study type: Interventional

Summary: 
      This study is investigating the effect of 8 weeks of orange juice supplementation on
      executive function in healthy older adults. The study is a controled, double-blind, crossover
      trial and involves a 8 week supplementation with a high flavonone orange juice and a
      carbohydrate-matched control. Volunteers consume 500ml of either the test juice or the
      control juice per day for an 8 week period. There is then an 8 week washout period before
      subjects proceed to the other arm of the study. Subjects are randomly assigned to either arm
      at the beginning of the study. Measures of cognitive function will be administered pre and
      post both test and control interventions. Blood pressure will also be measured and blood and
      urine samples will be collected to assess absorption of from the juice. A sub-sample of
      volunteers will undergo MRI imaging pre- and post intervention to acquire cerebral blow flow
      information.
    


Intervention name(s): High flavanone orange juice; Control orange juice
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): High flavonone orange juice drink.; Orange beverage, low flavanone content, matched for total carbohydrate content, individual sugar profile, vitamin C
Other intervention name(s): Frozen Orange Juice; Department of Citrus, Florida, USA.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: orange juice; cognitive function; flavonoids; flavanones
To Demonstrate the Relative Bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride Capsules (Pulvules) In Healthy Adult Males Under Fasting Conditions
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the relative bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine
      Hydrochloride capsules (Pulvules) in healthy adult males under fasting conditions.
    


Intervention name(s): Fluoxetine Hydrochloride 20 mg Capsules (Geneva Pharmaceutical, Inc.); Prozac Fluoxetine Hydrochloride 20 mg Capsules (Dista)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dexmedetomidine Improves Recovery After Cranial Aneurysm Surgery
Condition: Aneurysm Cerebral
MeSH terms: Intracranial Aneurysm; Aneurysm
Study type: Interventional

Summary: 
      Dexmedetomidine induces analgesic and sedative effects and is reported to decrease agitation
      during emergence after general anesthesia in various surgeries. For patients undergoing
      cranial aneurysm surgeries, a calm anesthesia and emergence is important. In this study, the
      investigatorstend to observe the effect of dexmedetomidine on maintenance and recovery of
      patients undergoing cranial aneurysm surgeries.
    


Intervention name(s): Intravenous dexmedetomidine; nasal dexmedetomidine; intravenous saline; nasal saline
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): drug is intravenously infused to patients; drug is nasally given to patients; saline is given to patients intravenously; normal saline is given to patients nasally
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: dexmedetomidine; general anesthesia; cerebral aneurysm
Lipid Profile Response to Electroacupuncture Stimulation in Non Alcoholic Fatty Liver Patients
Condition: Fatty Liver , Electroacupuncture, Lipid Profile
MeSH terms: Fatty Liver
Study type: Interventional

Summary: 
      sixty female patients suffering from non-alcoholic fatty liver disease were randomly divided
      into two equal groups group 1 received electroacupuncture stimulation for 6 weeks at special
      points of stimulation. group 2 was a control group that received nothing without any change
      in lifestyle and we assed the response of lipid profile post-treatment protocol in both
      groupes
    


Intervention name(s): electro-acupuncture stimulation
Intervention type(s): Device
Intervention description(s): stimulation of acupoints of the liver meridian of lv3 lv14
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: two group study, one is the study group and the other is a control group
Masking: None (Open Label)
Primary purpose: Treatment
FEIBA and Use of Blood Products in Cardiac Surgery
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this pilot study is to evaluate the feasibility of the prophylactic
      administration of Factor VIII Inhibitor Bypass Activity (FEIBA) at termination of
      cardiopulmonary bypass (CPB) period. Specifically, the proposed study is designed to
      demonstrate the potential role of FEIBA administration in reducing the need for allogeneic
      transfusion to treat refractory coagulopathy in high risk patients.
    

Detailed description: 
      Factor eight inhibitor bypassing activity (FEIBA) is currently approved for use in this
      country for the treatment of patients with Hemophilia and inhibitors at a dose of 50-100
      units/kg. There is a large body of evidence demonstrating the safety and efficacy of FEIBA
      for Hemophilia patients with inhibitor and has a theoretical advantage compared to current
      blood product transfusion methods, as it replenishes multiple depleted factors that are lost
      with prolonged exposure to CPB.

      This pilot study is a single center, randomized, double-blinded, placebo controlled trial
      assessing the feasibility and safety of factor eight inhibitor bypass activity (FEIBA) in
      patients undergoing major cardiovascular surgery requiring prolonged CPB. The study
      population will consist of adult patients undergoing elective cardiac surgery at OHSU. Twelve
      participants will randomly assigned to receive FEIBA or placebo during their surgical
      procedure.

      Patients will be followed to review for adverse events while in the ICU, and up to four weeks
      after discharge.
    

Intervention name(s): FEIBA; Normal Saline
Intervention type(s): Drug; Drug
Intervention description(s): Administration of FEIBA after cardiopulmonary bypass; Administration of placebo after cardiopulmonary bypass
Other intervention name(s): Anti-Inhibitor Coagulant Complex; NaCl 0.9%
Intervention MeSH terms: Coagulants; Anti-inhibitor coagulant complex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cardiopulmonary Bypass; Aortic Valve Repair; Coronary Re-Implantation; Deep Hypothermic Circulatory Arrest; Factor VIII Inhibitor Bypass Activity; Transfusion