bioihbjkbjnl/mcl2 huggingface dataset:
Comparison Between Effect of Acetazolamide and NaHco3 in Prevention of Contrast Nephropathy
Condition: Contrast Induced Nephropathy
MeSH terms: Kidney Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is whether Acetazolamide is effective in prevention of contrast
      nephropathy
    

Detailed description: 
      Contrast induced nephropathy is one of common causes of acute renal failure many preventive
      protocol existed . 240 patient that underwent coronary angiography randomly divided in three
      groups.Group 1,2,3 will receive Bicarbonate ,Acetazolamide+Normal salin and Normal salin
      respectively.We compare prevalence of contrast nephropathy in each group.
    

Intervention name(s): sodium bicarbonate; Acetazolamide; normal salin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 150 meq/l Sodium bicarbonate 3cc/kg/hr before and 1cc/kg/hr after angiography; Acetazolamide 250 mg+ 1 cc/kg/hr normal salin before and after angiography; 1 cc/kg/hr 6 hour before and after angiography
Other intervention name(s): no other name; Diamox; no other name
Intervention MeSH terms: Acetazolamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Low Back Pain and Motor Control Dysfunction After Pregnancy- the Possible Role of Abdominal Rectus Muscle Diastasis
Condition: Diastasis Recti
MeSH terms: Back Pain
Study type: Observational [Patient Registry]

Summary: 
      The aim of this study was to compare participants with increased symptoms after index
      pregnancy with those reporting no change in back pain or subjective movement control and
      analyzed their inter rectus distance (IRD). This study is a case-control study of a cohort of
      women who had delivered a year earlier. We recruited participants with increased symptoms
      (n=14) after index pregnancy and controls (n=41) and recorded their inter rectus distance
      with ultrasound. A questionnaire was filled, and an ultrasound was performed two times for
      the study groups.
    

Detailed description: 
      A case control study was conducted in Helsinki University Hospital during 1.1.2018-31.3.2021.

      Participants were enrolled in pregnancy screening unit. Exclusion criteria was pregnancy
      during the second questionnaire and body mass index over 28kg/m2. The first questionnaire was
      filled and the baseline width of linea alba was measured by abdominal ultrasound (US) in
      connection of the first early pregnancy screening during 1.1.2018-8.3.2019. The second
      electronic questionnaire was sent a year after the expected delivery timing. Two screening
      questions were used to grade the participants. Altogether 36 individuals scored at least five
      points reflecting to substantial increase in symptoms in screening questions in the second
      questionnaire after pregnancy out of which fourteen participants were randomly recruited.
      Another 94 individuals scored the lowest possible two points implicating no change in ones
      bodily experience. Three controls per case were recruited, altogether 42 controls and with
      one dropout the total number of controls was 41. All participants had at least 12 months from
      the last delivery.

      Two physiotherapists conducted motor control tests and the width of linea alba was measured
      with a high-end ultrasound. The physiotherapists were blinded with group allocation and the
      previous IRD measurement. Participants did not know their own exposure status or their IRD
      when answering the questionnaires.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants were enrolled in pregnancy screening unit during the first pregnancy screening
        ultra sound.
A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Subcutaneous Injection of JNJ-64304500 in Healthy Japanese and Caucasian Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to assess the safety, tolerability, and pharmacokinetics
      (PK) following single-dose subcutaneous (SC) injection of JNJ-64304500 in healthy Japanese
      male participants.
    


Intervention name(s): JNJ-64304500; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive JNJ-64304500 as SC injection.; Participants will receive matching placebo to JNJ-64304500 as SC injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Pharmacokinetics of Bictegravir in Adults With Normal and Impaired Renal Function
Condition: HIV
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of oral
      bictegravir (formerly GS-9883) in adults with impaired renal function relative to matched,
      healthy controls with normal renal function. Each participant in the renal impairment groups
      will be matched for age (± 10 years), gender, and body mass index [BMI (± 20%, 18 ≤ BMI ≤ 40
      kg/m^2)] with a participant in the control group.
    


Intervention name(s): Bictegravir
Intervention type(s): Drug
Intervention description(s): 75 mg tablet administered orally
Other intervention name(s): GS-9883
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Phase 1; Renally Impaired
The Jewels in Our Genes Study - an African American Family Study of Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The research team is studying why some African American families have multiple cases of
      breast cancer.

      This study will help to better understand if there are undiscovered genes unique to African
      Americans that may predict early breast cancer risk.

      Breast cancer survivors AND their relatives who are also breast cancer survivors are being
      recruited to the study.
    


Observational model: Family-Based
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        African American breast cancer survivors.
      
Biospecimen description: 
      Saliva sample
BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose in Multiple Sclerosis (MS) Patients
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine

        -  whether treatment with Betaferon / Betaseron (interferon beta-1b) 500 micrograms safe,
           tolerable and more efficacious than treatment with interferon beta-1b 250 micrograms

        -  whether treatment with Betaferon / Betaseron (interferon beta-1b) tolerable and more
           efficacious than treatment with Copaxone (Glatiramer Acetate) 20 mg
    

Detailed description: 
      This study has previously been posted by Berlex, Inc. and Schering AG, Germany. Berlex, Inc.
      has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been
      renamed to Bayer Schering Pharma AG, Germany.

      Bayer HealthCare Pharmaceuticals, Inc.and Bayer Schering Pharma AG, Germany are the sponsors
      of the trial.
    

Intervention name(s): Interferon beta-1b (Betaferon/Betaseron, BAY86-5046); Interferon beta-1b (Betaferon/Betaseron, BAY86-5046); Copaxone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 250mcg administered s.c. every other day; 500mcg administered s.c. every other day; 20 mg administered s.c. once daily.
Intervention MeSH terms: Interferons; Interferon-beta; Glatiramer Acetate; Interferon beta-1b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Relapsing multiple sclerosis; interferon beta 1b; Betaferon; Betaseron
Assessment of Stress Levels in Consumers Using Ovulation Tests in Order to Conceive
Condition: Stress
Study type: Observational

Summary: 
      Approximately 150 female volunteers wishing to become pregnant will be recruited via web
      recruitment from around the UK and randomised 1:1 to receive Clearblue Digital ovulation
      tests (active arm) or no aid to conception (control arm) for 2 full menstrual cycles. All
      volunteers will complete study questionnaires and provide a urine sample at designated time
      points though out the menstrual cycle.

      A sub-arm to this study, applied the same protocol to women in an infertility treatment
      setting; Royal Hallamshire Hospital, Sheffield. Additional exclusion criteria were applied to
      this cohort; had regular menstrual cycles between 25 and 35 days, and who did not have a
      diagnosis of bilateral or unilateral tubal blockage, documented anovulation or severe
      male-factor infertility (with <5 million motile sperm per ejaculate). For this arm, the
      protocol was reviewed by Sheffield Research Ethics Committee 09/H1308/134.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Females aged 18 to 40 wishing to become pregnant
      
Biospecimen description: 
      Urine samples
    
Keywords: Pregnancy; Ovulation tests; stress; Wishing to become pregnant
Study to Evaluate the Effects of Food Ingestion on the Pharmacokinetics of CHF 5074 in Healthy Young Male Subjects
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the effects of a high-calorie high-fat meal on the extent and rate of absorption
      of CHF 5074 after single oral administration in young healthy male volunteers.
    


Intervention name(s): CHF 5074; CHF 5974
Intervention type(s): Drug; Drug
Intervention description(s): Drug is administered to subject in a fasting state; Drug is administered to subject after consumption of a high fat, high calorie meal
Intervention MeSH terms: 1-(3',4'-dichloro-2-fluoro(1,1'-biphenyl)-4-yl)cyclopropanecarboxylic acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare the effect of denosumab produced by two different manufacturing
      processes on bone mineral density at the lumbar spine in postmenopausal women with
      osteoporosis.
    


Intervention name(s): Denosumab (CP2); Denosumab (CP4)
Intervention type(s): Drug; Drug
Intervention description(s): Denosumab produced by a process referred to as CP2, administered subcutaneously from a prefilled syringe.; Denosumab produced by a process referred to as CP4, administered subcutaneously from a prefilled syringe.
Other intervention name(s): XGEVA®
Intervention MeSH terms: Denosumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: postmenopausal osteoporosis; osteoporosis; postmenopausal; denosumab; women
Safety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to characterize the safety and efficacy in patients with
      generalized anxiety disorder after short- (3 months) and long-term (6 months) use of
      Pregabalin (Lyrica).
    


Intervention name(s): Pregabalin; Lorazepam; Pregabalin; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Pregabalin 150-300 mg given twice a day; Lorazepam 3-4 mg given twice a day; Pregabalin 450-600 mg given twice a day; Placebo
Other intervention name(s): Lyrica; Lyrica
Intervention MeSH terms: Pregabalin; Lorazepam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparison of Escitalopram Combination in Adult Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are
      selective serotonin reuptake inhibitors (SSRIs) and are used to treat depression in adults.
      This study is designed to evaluate the efficacy and safety of a fixed-dose escitalopram
      combination relative to its component monotherapies and to placebo in patients with major
      depressive disorder.
    


Intervention name(s): Escitalopram
Intervention type(s): Drug
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Depression; Major Depressive Disorder; Escitalopram
Cupping Therapy in Nonspecific Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Introduction: Low back pain is a very prevalent condition in the population and windsurf
      therapy has been presented as a non-pharmacological treatment currently used in this
      population. However, there is a lack of studies that evaluate such effects, besides a
      standardization of application of the technique in this condition. This protocol describes a
      placebo-controlled, randomized, double-blind study that aims to assess the effectiveness of
      windsurf therapy in improving pain and other symptoms of individuals with chronic
      non-specific back pain. Methods: Ninety individuals with chronic nonspecific and localized
      chronic low back pain from 18 to 59 years, will be recruited according to the inclusion
      criteria. Afterwards they will be randomized to one of the 2 groups: intervention group (GI)
      where it will be submitted applied to the windspiration with 2 suctions; and placebo group
      (GP) with simulated application. Both applications will occur in parallel to the vertebrae
      from L1 to L5 bilaterally. The application will be performed once a week for eight weeks. The
      volunteers will be evaluated before treatment (T0), immediately after the first intervention
      (T1), 4 weeks after treatment (T4) and 8 weeks after treatment (T8). The primary endpoint
      will be pain, and the secondary ones will be kinesiophobia, physical function, lumbar range
      of motion, sleep quality, patient expectation, quality of life, and psychological factors.
      Discussion: This is the first protocol that proposes to evaluate the effect of windsotherapy
      on lumbar ROM, sleep quality, kinesiophobia and psychological problems. Few studies have been
      done on windsurfing individuals with low back pain, requiring further studies with good
      methodological quality. Because there is no consensus on the use of windsurf therapy in
      individuals with nonspecific chronic low back pain, our protocol will be the basis for the
      use of the technique by health professionals and for new studies to be performed.
    

Detailed description: 
      This study will involve 4 researchers; 1 researcher responsible for evaluations; 1 researcher
      responsible for interventions; 1 researcher responsible for the interview, initial screening
      and randomization of participants, and 1 researcher who will perform the statistical
      analysis.
    

Intervention name(s): Cupping Therapy
Intervention type(s): Other
Intervention description(s): application of cupping therapy with two acrylic type 1 cups (4.5 cm internal diameter, Dong Yang ® brand) with a distance of 3 cm each cup, parallel to the L1 to L5 vertebrae bilaterally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: low back pain; cupping therapy
Vaccine Therapy in Treating Patients With Philadelphia Chromosome-Positive Chronic Myelogenous Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Vaccines made from peptides may help the body build an effective immune response
      to kill cancer cells. Colony-stimulating factors, such as GM-CSF, may increase the number of
      immune cells found in bone marrow or peripheral blood. Giving booster vaccinations may make a
      stronger immune response and prevent or delay the recurrence of cancer.

      PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients
      with Philadelphia chromosome-positive chronic myelogenous leukemia.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the activity of bcr-abl p210-b3a2 breakpoint-derived pentapeptide vaccine
           (CMLVAX100), in terms of peripheral blood bcr-abl/abl ratio reduction, in patients with
           Philadelphia chromosome-positive chronic myelogenous leukemia.

      Secondary

        -  Determine the reduction of molecular residual disease at 3 months in patients treated
           with this vaccine.

        -  Determine the reduction of molecular residual disease at 12 months in patients treated
           with maintenance boosts of this vaccine.

        -  Determine the rate of complete molecular response at any time after vaccination.

        -  Determine in vivo and in vitro peptide-specific immune response induced by the vaccine.

      OUTLINE: This is a prospective, nonrandomized, open-label, multicenter study.

      Patients receive sargramostim (GM-CSF) subcutaneously (SC) on days 1 and 2 and bcr-abl
      p210-b3a2 breakpoint-derived pentapeptide vaccine (CMLVAX100) SC on day 2. Treatment repeats
      every 2 weeks for 6 courses. Patients then receive CMLVAX100 SC once monthly for 3 months and
      then once every 3 months for 6 months (for a total of 1 year). Patients may receive
      additional CMLVAX100 SC every 6 months for at least 3 years. Treatment continues in the
      absence of disease progression or unacceptable toxicity.

      PROJECTED ACCRUAL: A total of 69 patients will be accrued for this study.
    

Intervention name(s): bcr-abl p210-b3a2 breakpoint-derived multipeptide vaccine; sargramostim
Intervention type(s): Biological; Biological
Intervention MeSH terms: Sargramostim
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic myelogenous leukemia, BCR-ABL1 positive; accelerated phase chronic myelogenous leukemia; blastic phase chronic myelogenous leukemia; chronic phase chronic myelogenous leukemia; relapsing chronic myelogenous leukemia
Comparative Effects of Aspirin and NHP-544C
Condition: Healthy
Study type: Interventional

Summary: 
      The investigators will compare the effects of rapid release aspirin and NHP-544C on the
      prostacyclin response to intravenous bradykinin.
    


Intervention name(s): Bradykinin; Aspirin 81 mg; Aspirin 162 mg; NHP544-C 81 mg; NHP544C 162 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.; Subjects will take Aspirin 81 mg per day for five days.; Subjects will take aspirin 162 mg per day for 5 days.; Subjects will take NHP544C 81 mg per day for five days.; Subjects will take NHP544C 162 mg once a day for five days.; Subjects will take matching placebo for five days.
Other intervention name(s): BK; ASA 81 mg; ASA 162 mg
Intervention MeSH terms: Aspirin; Bradykinin; Kininogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
The Usefulness of Ultrasound Guided Technique Insertion of Radial Artery Catheter in Neonates and Infants
Condition: Catheterization, Peripheral
Study type: Interventional

Summary: 
      The investigators are trying to compare the ultrasound-guided technique vs. palpation method
      for radial arterial cannulation in infants.
    

Detailed description: 
      In infants (<12mo), radial arterial catheterization is sometimes difficult to perform.
      Moreover, repeated attempts itself would cause the arterial spasm or hematoma. The use of
      ultrasound as an adjunct to radial arterial cannulation has considered to be the best
      practice in adults and pediatrics. However, its usefulness or superiority for neonates and
      infants is not known. Therefore, we would compare ultrasound guided radial arterial
      cannulation with the usual palpation methods in infants undergoing cardiac surgery.
    

Intervention name(s): Radial arterial cannulation
Intervention type(s): Procedure
Intervention description(s): Radial arterial cannulation using usual palpation method or ultrasound guided technique according to the group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Peripheral; Arterial; Catheterization
Angiosome Perfusion After Tibial Bypass
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      Microcirculation should be assessed before and after tibial bypass surgery by intraoperative
      fluorescence angiography. According to this, the direct and the indirect angiosomes should be
      compared according to the individual microcirculatory improvement.
    

Detailed description: 
      Only patients at CLI stage Rutherford IV to VI with the necessity of tibial Bypass surgery
      will be included. Macrocirculation is measured by the ankle-brachial index (ABI). In order to
      assess the skin microcirculation intraoperative fluorescence angiography is used (SPY Elite™,
      NOVADAQ, Canada). The alteration of microcirculation is compared in direct and indirect
      revascularized angiosomes by calculation of the fluorescence parameters Ingress (IN) and
      Ingress rate (InR). Clinical Follow-up investigations will be performed and the wound healing
      rate is compared between the different revascularization methods.
    

Intervention name(s): Indocyanine Green
Intervention type(s): Drug
Intervention description(s): Perioperative application of 0.1 mg ICG per kg Body weight
Intervention model: Single Group Assignment
Primary purpose: Diagnostic