bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Carbon-14-Labelled [14C] LY3871801 in Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate how much of the study drug (LY3871801),
      administered as a single dose that has the radioactive substance 14C incorporated into it,
      passes from blood into urine, feces and expired air in healthy male participants. The study
      will also measure how much of the study drug gets into the bloodstream, how its broken down,
      and how long it takes the body to get rid of it. The study will last up to approximately 9
      weeks including the screening period.
    


Intervention name(s): [14C]-LY3871801
Intervention type(s): Drug
Intervention description(s): Administered orally
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study in Healthy Volunteers, to Evaluate the Safety, Efficacy and Dose Responses of SB-751689 (Ronacaleret)
Condition: Transplantation, Stem Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      The present study aims to evaluate the impact of 5 days oral administration of ronacaleret
      100 miligram (mg) and 400 mg on changes in circulating CD34+ cells, when ronacaleret is
      followed by the administration of a single dose of plerixafor in healthy human volunteers.

      This single centre adaptive design study will be carried out in 2 parts. The part A will
      evaluate the change in peripheral circulating CD34+ cells in response to two different 5 day
      regimens of ronacaleret (100 mg or 400 mg once daily), given in conjunction with a single
      dose of plerixafor (0.24 mg/kilogram [kg]) sub-cutaneously (SC) on the evening of the final
      days dosing approximately 12 hours before collection of CD34+ cells on day 6. Subjects (5
      each) will be assigned to either one of the ronacaleret arms, in an open fashion. Comparisons
      will be made in the change from baseline to end of treatment peripheral CD34+ cell counts.
      Part A will be conducted in two cohorts with 5 subjects being enrolled into each of the 2
      treatment arms making up the first cohort. Cohort 2 will involve up to 5 further subjects
      being enrolled into each treatment arm.

      The structure of part B will be finalized following a review of data generated in part A.

      The total study duration of Part A for each subject including the screening, treatment and
      follow-up periods will be approximately 7 weeks.
    


Intervention name(s): Ronacaleret 100 mg; Ronacaleret 400 mg; Plerixafor
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects in the Ronacaleret 100 mg group received one tablet orally of ronacaleret 100 mg for 5 consecutive days.; Subjects in the Ronacaleret 400 mg group received four tablets orally of ronacaleret 100 mg daily for 5 consecutive days.; Subjects in each group received a single dose of plerixafor (0.24mg/kg) SC on the evening of the Day 5 dosing approximately 12 hours before collection of CD34+ cells on day 6.
Intervention MeSH terms: Plerixafor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ronacaleret; parathyroid hormone (PTH); CD34+cells; calcium sensing receptor antagonist; hematopoietic stem cells; stem cell mobilization; plerixafor; healthy human volunteer, phase Ib
Confocal Laserscanning Microscopy for Detection of Barretts Esophagus
Condition: Barrett Esophagus
MeSH terms: Barrett Esophagus
Study type: Interventional

Summary: 
      Four quadrant biopsies in regular ranges is the goldstandard in monitoring this disease. The
      ideal situation for the endoscopist is to visualize cellular structures, which implies having
      microscopic imaging available. A potential candidate to fill this gap could be confocal
      fluorescence microscopy (Cellvizio®-GI and Mauna Kea Technologies). To compare the gold
      standard with the confocal fluorescence microscopy for detection of metaplastic - or
      intraepithelial neoplastic changes of barrett-suspicious esophageal mucosa this study has
      been initiated.
    


Intervention name(s): confocal laser microscopy
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Diagnostic
Prostate Core Needle Biopsy
Condition: Biopsy; Prostate; Complication
Study type: Interventional

Summary: 
      Prostate tissue biopsy is performed with either transrectal or transperineal approach. These
      two methods are usually based on tissue sampling with an ultrasound-guided core needle
      biopsy. Transperineal prostate biopsy can be done either with a conventional noncoaxial
      technique or with a coaxial technique. In conventional transperineal technique, biopsy needle
      is inserted repeatedly for each tissue sampling. Alternatively, a coaxial needle can be
      placed over the perineum; then, the direction of the biopsy can be changed by tilting the
      coaxial needle. In this prospective study, the investigators sought to compare the procedural
      time and the complication rate of coaxial technique with those of noncoaxial technique in
      transperineal prostate biopsy.
    


Intervention name(s): coaxial prostate biopsy; noncoaxial prostate biopsy
Intervention type(s): Device; Device
Intervention description(s): In this method, a larger introducing needle is needed for the puncture. The introducing needle is placed over the perineum. The biopsy needle is inserted throughout the introducing needle.Then, the direction of the biopsy is changed by tilting the coaxial needle. The investigator needs to puncture the prostate capsule only once for sampling at each each side of the prostate (right and left sides).; In this method, there is no introducing needle. Biopsy needle is inserted repeatedly for each tissue sampling (at least fourteen times). A smaller biopsy needle is used for the puncture in this method.
The main disadvantage of the coaxial technique is that a larger introducing needle is needed for the puncture (12). On the other whand, the advantage of noncoaxial method is that the needle is within the prostate for only a few seconds to document needle position with ultrasonography before firing
Other intervention name(s): coaxial Tru-Cut needle (18-gauge Bard Max-Core Disposable Core Biopsy Instrument, 17-gauge Bard TruGuide Disposable Coaxial Needle; C. R. Bard, Tempe, USA); noncoaxial 18-gauge needle (Bard Max-Core Disposable Core Biopsy Instrument; C. R. Bard, Tempe, USA)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Exercise Pulseoximetry for Pre-flight Evaluation of Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: Chronic Obstructive Pulmonary Disease; Hypoxemia
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Hypoxia
Study type: Observational

Summary: 
      Some patients with chronic obstructive pulmonary disease (COPD) need supplementary oxygen
      during air travel. Guidelines issued by The British Thoracic Society (BTS) for pre-flight
      evaluation do not discriminate sufficiently between those who need supplementary oxygen
      during flight, and those who can do without. Previous studies have indicated that decreasing
      hemoglobin oxygen saturation during exercise may predict in-flight hypoxemia. The objective
      of the present study is to examine if adding exercise oxygen desaturation to the BTS
      algorithm will better predict requirements for in-flight supplementary oxygen.
    

Detailed description: 
      The British Thoracic Society (BTS) guidelines on pre-flight evaluation for patients with
      chronic respiratory disease is based on an algorithm where arterial oxygen saturation is the
      discriminating factor. It has recently been shown that this algorithm does not discriminate
      sufficiently between patients who need pre-flight evaluation and maybe supplementary oxygen
      during air travel, and those who can travel by air without supplemental oxygen or further
      evaluation. Studies have also shown that exercise desaturation may predict in-flight
      hypoxemia. The objective of the present study is to examine if inclusion of arterial oxygen
      saturation measured by pulseoximetry during exercise in the BTS algorithm, will increase the
      sensitivity and specificity of the BTS pre-flight evaluation guidelines.The study also
      include questionnaires on symptoms during air travel carried out before ande after the
      pre-flight evaluation.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        COPD patients
      
Keywords: Chronic obstructive pulmonary disease; Hypoxemia; Pre-flight evaluation; Hypobaria; COPD; Pulseoximetry; Air travel; Exercise desaturation
An Investigation Into the Efficacy of Provodine Topical Cream as Compared to 10% Benzoyl Peroxide Wash for the Treatment of Hidradenitis Suppurativa.
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Study type: Interventional

Summary: 
      The purpose of this study is to compare the efficacy of Provodine™ topical cream to 10%
      benzoyl peroxide topical body wash for the treatment of early stage hidradenitis suppurativa.
    

Detailed description: 
      Hidradenitis suppurativa (HS) is a chronic, recurrent inflammatory disease of the skin. It
      typically manifests as nodules and abscesses that ultimately can progress to form deep sinus
      tracts, fistulas, and scarring. It affects areas of the body with apocrine gland bearing
      tissue, including the anogenital, axillary and inframammary regions. The lesions are often
      very painful and can chronically drain malodorous fluid, which can leave affected individuals
      uncomfortable and self-conscious, or even debilitated. The pathogenesis of this disease
      process is not fully understood, and the HS can be difficult to treat. Measures such as
      topical antibiotic and antiseptic washes are generally thought to be beneficial for the
      treatment of early stage HS. Although there have been no controlled trials for the treatment
      of HS, commonly used topical washes currently include benzoyl peroxide and chlorhexidine
      gluconate.

      Provodine™ topical cream was designed to actively kill microbes on the skin for up to 6 hours
      without resulting in the irritation often associated with repetitive use of antimicrobial
      products. A blinded controlled comparison of Provodine™ versus the current standard of
      benzoyl peroxide wash will not only allow for an alternative treatment for early stage HS but
      also provide an additional tool in the arsenal of treatments for this disease process.
    

Intervention name(s): 10% Benzoyl Peroxide Topical Body Wash; Provodine Topical Cream
Intervention type(s): Drug; Drug
Intervention MeSH terms: Benzoyl Peroxide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Hidradenitis Suppurativa; HS; Acne Inversa; Velpeau's disease; Verneuil's disease
Oral Insulin: A Comparison With Subcutaneous Regular Human Insulin in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study compared the pharmacokinetic and pharmacodynamic properties of an oral insulin
      formulation with that of a standard subcutaneous injection of regular human insulin.
    

Detailed description: 
      This study was a single centre, randomized, 3-period crossover study performed in patients
      with type 2 diabetes. Patients received single doses of an oral insulin formulation and
      subcutaneous regular human insulin on separate visits.

      The primary objective of this study was to compare the pharmacokinetic and pharmacodynamic
      properties of an oral insulin formulation with that of 15 U subcutaneous injected regular
      human insulin.

      Pharmacokinetic and pharmacodynamic parameters including bioavailability and bioefficacy were
      measured during 6-hour glucose clamp experiments.

      Study duration: 2 months
    

Intervention name(s): Oral insulin; regular human insulin
Intervention type(s): Drug; Drug
Intervention description(s): oral insulin capsule formulation (150 U insulin/200 mg 4-CNAB in one capsule); single dose administration of 300 U insulin (in two capsules) and of 150 U insulin (one capsule) on two separate dosing days.; subcutaneous injection of 15 U regular human insulin; single dose administration on one separate dosing visit.
Other intervention name(s): Humulin R (100 U/mL)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 Diabetes; Oral Insulin; Pharmacokinetics; Pharmacodynamics
Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation
      may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by
      peripheral stem cell transplantation in treating women who have breast cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine long term remission rates as measured by disease free survival in
      women with breast cancer treated with cyclophosphamide, thiotepa, and carboplatin followed by
      autologous hematopoietic stem cell transplantation. II. Determine the safety and efficacy of
      this combination chemotherapy regimen in this patient population.

      OUTLINE: Peripheral blood stem cells (PBSC) are collected. Patients sequentially receive
      cyclophosphamide IV over 1 hour, thiotepa IV over 1 hour, and carboplatin IV over 1 hour on
      days -6 to -4. PBSC are reinfused on day 0. Patients are followed at 3 months, 6 months, 1
      year, and then annually thereafter.

      PROJECTED ACCRUAL: At least 40 patients with 4-9 positive lymph nodes and at least 50
      patients with 10 positive lymph nodes will be accrued for this study.
    

Intervention name(s): Carboplatin; Cyclophosphamide; Thiotepa
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Carboplatin will be given at a dose of 267 mg/m2 in D5 W IV over one hour daily on days -6, -5, and -4. (Total dose 800 mg/m2); Cyclophosphamide will be given at a dose of 2000 mg/m2 in NS IV over one hour daily on days -6, -5, and -4. (Total dose 6000 mg/m2); Thiotepa will be given at a dose of 167 mg/m2 in NS IV over one hour daily on days -6, -5, and -4. (Total dose 500 mg/m2 )
Other intervention name(s): Paraplatin(R)
Intervention MeSH terms: Cyclophosphamide; Thiotepa; Carboplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage II breast cancer; stage IV breast cancer; stage IIIA breast cancer; recurrent breast cancer; stage IIIB breast cancer; inflammatory breast cancer
Heartrate and Breathing Effects on Attention and Memory
Condition: Aging; Alzheimer Disease; Age-related Cognitive Decline
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional

Summary: 
      In the current study, we will examine how daily paced breathing affects plasma amyloid beta
      levels and the rate of learning in older adults. Healthy adults aged 50-70 who meet all
      eligibility criteria will be invited to this study. Participants will be randomly assigned to
      one of the two conditions: 1) Daily memory and attention training followed by a paced
      breathing protocol designed to increase relaxation or 2) Daily memory and attention training
      followed by a paced breathing protocol to increase alertness. Participants will be asked to
      complete pre and post intervention cognitive testing online, engage in 10 weeks of daily
      brain training (starting Week 2) and 9 weeks of paced breathing (starting Week 3) at home.
      They will also be asked to come in for lab visits on Weeks 2, 7 and 12 to provide blood and
      urine samples to assess amyloid beta levels and to complete magnetic resonance imaging scans
      to assess perivascular space volume.
    


Intervention name(s): Brain training; Paced breathing
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will play a few brain training games using an online interface each day. These games train attention, memory and other cognitive functions.; After completing brain training, they will then immediately do one 15-minute session of paced breathing, followed by a second 15-min session of paced breathing later in the day. During the paced breathing sessions, participants will clip a pulse monitor to their ear lobe and try to inhale and exhale in synchrony with a ball that moves up and down on the screen. They will receive heart rate biofeedback regarding whether they are achieving their relaxation/alertness goal.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Randomized Comparative Efficacy and Safety Study of Intermittent Simvastatin and Fenofibrate in Hemodialysis
Condition: Fenofibrate/Simvastatin Comparison
Study type: Interventional
Phase: Phase 4

Summary: 
      Sixty chronic hemodialysis patients were randomly assigned to receive fenofibrate 100 mg
      (group 1, n = 30) or simvastatin 20 mg (group 2, n = 30) three times/week after their
      dialysis session. The safety and efficacy of drugs on lipid profile, oxidized low density
      lipoproteins (ox-LDL), glutathione peroxidase (GSH-Px) and C-reactive protein (CRP) were
      compared before and after 16-week treatment.
    

Detailed description: 
      This is a prospective randomized open label parallel study.

      The selected patients will be randomly allocated to one of two groups

        -  Group I (30 patients): Patients receiving fenofibrate (100 mg) taken on dialysis days
           after the dialysis session (three times per week).

        -  Group II (30 patients): Patients receiving simvastatin (20 mg) taken on dialysis days
           after the dialysis session (3 times per week).

      A careful history of all patients including demographic characteristics, physical
      examination, chief complaint, past medical history, drug history, familial history, social
      history, disease(s).

      Monitoring Parameters:

      For efficacy, the following parameters are measured:

        1. Lipid profile (total cholesterol, HDL, TG and LDL from Friedwald formula [10] {LDL-C=
           TC-[HDL + TG\5]). (measured at baseline and every month for 4 months)

        2. C-reactive protein (CRP). (measured at baseline and after 4 months)

        3. Oxidative stress markers: oxidized LDL and human glutathione peroxidase (measured at
           baseline and after 4 months).

      For safety: (measured at baseline and every month for 4 months)

        1. Observe for signs & symptoms of muscle toxicity and measure phosphocreatine kinase
           (CPK).

        2. Liver function tests: ALT, AST, ALP & albumin.

        3. Urea & serum creatinine. (to monitor renal function)

        4. Hemoglobin

        5. Other measurements: Body mass index (BMI), Blood Pressure, electrolytes
           (Sodium,potassium, calcium, phosphorous) and assess patient compliance by tablet
           counting.

      Statistical analysis will be used to compare the effects of simvastatin and fenofibrate on
      lipid profile, inflammatory marker (CRP) and oxidative stress markers (oxidized LDL and
      glutathione peroxidase). In addition, comparing their safety on renal and hepatic functions,
      phosphocreatine kinase, blood pressure and blood glucose level.
    

Intervention name(s): Fenofibrate; Simvastatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Simvastatin; Fenofibrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fibrates; Statins; Hemodialysis; Dyslipidemia; Improved Oxidative Stress; Egypt
Ghrelin With Anorexia Nervosa
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Observational

Summary: 
      The PICOWO research group in corporation with the University of Amsterdam (Artificial
      Intelligence) has developed a computer simulationmodel of eating disorders (Bosse, Delfos,
      Jonker & Treur, 2003). In a running Phd project we want to add ghrelin to the model. The idea
      for this current research is to collect clinical information about the functioning and
      (patho)physiology of ghrelin in patients with AN, so we can extend the simulation.
    

Detailed description: 
      Eating disorders are in need of new perspectives. A better understanding of the appetite in
      patients with eating disorders, especially Anorexia Nervosa, could be investigated by the
      levels of ghrelin in patients with and without tube feeding.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Studypopulation: Patiënts: all female, non -age coupled. Subgroup patients without tube
        feeding, with tube feeding and a healthy matched control group.

        Control group: healthy volunteers of the University of Maastricht.
      
Biospecimen description: 
      Whole blood
    
Keywords: Anorexia Nervosa
Evaluation of Outcomes of Discectomy With Dynesys in Treatment of Lumbar Disc Herniation
Condition: Orthopedic Disorder of Spine
MeSH terms: Intervertebral Disc Displacement; Musculoskeletal Diseases; Spinal Diseases
Study type: Interventional

Summary: 
      To explore the clinical outcomes of discectomy with dynamic neutralization system(Dynesys) on
      treatment of single-segmental lumbar disc herniation(LDH) versus simple discectomy.
    

Detailed description: 
      The study was to explore the clinical outcomes of discectomy with dynamic neutralization
      system(Dynesys) on treatment of single-segmental lumbar disc herniation(LDH) versus simple
      discectomy. 128 patients with single-segmental LDH were randomly divided into discectomy with
      Dynesys group(group A) and simple discectomy group(group B). Both groups were evaluated by
      Visual Analogue Score(VAS), Oswestry Disability Index(ODI), radiological evidence of
      intervertebral height and range of motion(ROM) of the treated segment at pre- and
      post-operation. Operation duration and blood loss was recorded. The clinical outcomes and
      complications were evaluated afterwards. All patients received a 2-year follow-up.
    

Intervention name(s): Dynesys
Intervention type(s): Device
Intervention description(s): discectomy with Dynesys
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment