bioihbjkbjnl/mcl2 huggingface dataset:
Study of AMD3100 (Plerixafor) and Rituximab in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Condition: Chronic Lymphocytic Leukemia (CLL); Small Lymphocytic Lymphoma (SLL)
MeSH terms: Lymphoma; Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to determine if plerixafor can make CLL/SLL (Chronic
      Lymphocytic Leukemia/ Small Lymphocytic Lymphoma) cells more sensitive to being killed by
      rituximab, an anti-cancer drug that is commonly used in treating CLL and SLL. In this study,
      plerixafor will be added to standard treatment with rituximab. Subjects will be monitored to
      see how well they tolerate the use of these drugs together and how well they work to treat
      the leukemia.

      The primary objective is to determine the maximum tolerated dose (MTD) of plerixafor when
      combined with rituximab as treatment for previously treated patients with CLL or SLL.
    


Intervention name(s): plerixafor
Intervention type(s): Drug
Intervention description(s): Drug Course 1: plerixafor (20mg/mL). Dose escalation starting with 80 mcg/kg then 160, 240, 320, 420, and 540 mcg/kg, or to de-escalate to 40mcg/kg. Dosing 3 times/week for 3 weeks beginning at start of second week. Rituximab is also administered 3 times per week for 4 weeks using a fixed dose of 100 mg on Day 1 and a dose of 375 mg/m2 for all subsequent doses.
Drug Course 2: plerixafor (20 mg/m) same dose as course 1. Dosing 3 times/week for 4 weeks. Rituximab is also administered 3 times per week for 4 weeks using a dose of 375 mg/m2 for all doses.
Other intervention name(s): Mozobil(TM); AMD3100
Intervention MeSH terms: Plerixafor
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AMD3100; Rituximab; Chronic Lymphocytic Leukemia; CLL; Small Lymphocytic Lymphoma; SLL
Activity Counseling Trial (ACT)
Condition: Cardiovascular Diseases; Heart Diseases
MeSH terms: Cardiovascular Diseases; Heart Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      To develop and evaluate the effectiveness of various intervention approaches, delivered in
      primary health-care settings, in increasing and maintaining habitual physical activity and
      cardiorespiratory fitness among sedentary men and women patients.
    

Detailed description: 
      BACKGROUND:

      A conference on physical activity sponsored by the National Heart, Lung, and Blood Institute
      (NHLBI) in August 1991 recommended that one priority area for research should be the
      development and evaluation of interventions for adoption and maintenance of physical activity
      including interventions that can be incorporated into primary care practice. The 1992 NHLBI
      Working Group Report on Primary Prevention of Hypertension identified physical inactivity as
      a risk factor for hypertension. Intervention research applicable to health-care settings is
      particularly important in light of national recommendations advising health-care
      professionals to intervene, including Healthy People 2000, the U.S. Preventive Services Task
      Force reports, and the American Heart Association.

      DESIGN NARRATIVE:

      Randomized, multicenter, demonstration and education study. Men and women primary care
      patients at three sites in Dallas, Palo Alto, and Memphis were randomized to two patient
      education intervention groups or to a standard care control group of physician advice.
      Intervention continued for two years for all participants. The primary outcomes were
      cardiorespiratory fitness and physical activity. Other outcomes were effects on blood
      pressure, lipoproteins, and weight; the long-term maintenance of these effects; and the
      cost-effectiveness of various intervention approaches. Recruitment took 15 months and has
      been completed with the accrual of 874 subjects.

      The National Institute on Aging participated in the ACT through the addition of a measurement
      of arterial stiffness involving approximately 700 patients. The NIA tested the hypothesis
      that increases in physical activity resulting from educational interventions could reduce
      arterial stiffness.
    

Intervention name(s): health education
Intervention type(s): Behavioral
Allocation: Randomized
Primary purpose: Prevention
Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women
Condition: HIV
MeSH terms: HIV Seropositivity
Study type: Interventional

Summary: 
      The overall objective of this study is to evaluate whether the addition of secondary
      distribution HIV self-test kits to existing partner notification guidelines increases the
      proportion of male partners who access facility-based HIV testing services, when compared to
      the partner notification strategy alone
    

Detailed description: 
      Pregnant women 18 years of age or older who enter antenatal care at Chipata Level 1 Hospital
      in Lusaka, Zambia will participate.

      HIV-positive and HIV-negative pregnant women will be randomized to one of two groups: partner
      notification alone or partner notification plus secondary distribution of HIV self-test kits.
      Women will return to the clinic 30 days after enrollment for an exit visit during which time
      information about their experience with the partner notification strategies will be
      collected.

      A random sample of women and health care workers will also participate in qualitative
      interviews.
    

Intervention name(s): HIV self-testing with partner notification.
Intervention type(s): Behavioral
Intervention description(s): HIV self-test kits are oral swabs. Partner notification will be offered to all women in the intervention arm, regardless of HIV status.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Self Testing; Partner notification; Secondary Distribution
Pharmacokinetics (PK) and Pharmacodynamics (PD) Study of Single and Multiple Ascending Doses of JNJ-41443532 in Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety, tolerability, food effect as well as
      the pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the
      body and how it is removed from the body over time) and pharmacodynamics (the effects of the
      drug) of single and multiple ascending doses of JNJ-41443532 in healthy male participants.
    

Detailed description: 
      This is a randomized (study drug assigned by chance), double-blind (neither physician nor
      participant knows the name of the assigned drug), placebo-controlled, single and multiple
      ascending dose study conducted at a single study center. The study has 4 parts. Part 1 is a
      randomized, double-blind, alternating panel, single ascending oral dose study. Two
      alternating treatment panels (A and B) each with nine healthy male participants will be
      studied with successively increasing dose levels. Part 2 is a randomized, open-label (all
      people involved know the identity of the intervention), 2-period crossover study to evaluate
      what the effect of administering JNJ- 41443532 with food (i.e. standard high fat breakfast
      meal) relative to administration in the fasted state will have on pharmacokinetics/blood
      levels of JNJ-41443532. Part 3 is a randomized, double-blind, single oral dose study in
      obese, otherwise healthy male participants. Part 4 is a double-blind, randomized,
      placebo-controlled multiple ascending dose study in up to 5 sequential treatment groups of
      healthy male participants. Safety assessments include monitoring of adverse events, and
      evaluation of lab results, cardiac parameters, vital signs, and physical exams. In Parts 1,
      2, and 3 participants receive study medication (JNJ-41443532 or placebo) orally on Day 1
      after an overnight fast of at least 10 hours; planned doses are 25 to 1500 mg. In Part 4,
      participants receive study medication (JNJ-41443532 or placebo) orally each day for 10
      consecutive days after an overnight fast of at least 10 hours; planned doses are 100 to 1000
      mg.
    

Intervention name(s): JNJ-41443532; JNJ-41443532; JNJ-41443532; JNJ-41443532; JNJ-41443532; Placebo; JNJ-41443532
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 25mg tablet once daily; 250mg tablet once daily; 1500mg once daily (with 250mg tablets); 100mg tablet once daily; 1000mg once daily (with 250mg tablets); Matching placebo; 500mg once daily (with 250mg tablets)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Healthy Volunteers; Healthy; JNJ-41443532; Pharmacokinetics
Evaluation of Postoperative Pain After Using 3MIX-TATIN Versus Calcium Hydroxide Iodoform Paste In Necrotic Primary Molars Treated by Lesion Sterilization and Tissue Repair Therapy
Condition: Necrotic Pulp; Postoperative Pain
MeSH terms: Dental Pulp Necrosis; Pain, Postoperative; Necrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the current study is to compare a newly introduced material which is a combination
      of triple mix antibiotics paste and anti-hyperlipidemia drug simvastatin, the new material is
      named 3MIX-TATIN & will be compared to triple antibiotic paste for management of necrotic
      primary molars by using lesion sterilization and tissue repair LSTR technique.
    

Detailed description: 
      3Mix-tatin will prepared by mixing three commercially available antibiotics with simvastatin.
      After removing the coating materials, 3 types of antibiotics are pulverized by porcelain
      mortars and pestles to achieve fine powders. A total of 100 mg ciprofloxacin, 100 mg
      metronidazole, and 100 mg cefixime will be mixed in a ratio of 1: 1: 1. Two milligrams of
      simvastatin will be added to the drugs blend to form 3-Mix-tatin. Preparation of 3Mixtatin
      will be trained and supervised by an expert pharmacist. 3Mixtatin will be stored in a tightly
      capped porcelain container, adding a small amount of silica gel in a bag inside the container
      to maintain low humidity. This powder will be mixed with normal saline to form a creamy paste
      of 3Mixtatin at the time of application.

      Local anesthesia using mepivicaine hydrochloride 3% (septodont, saint-maurdesFosses, France)
      will be administered.

      Rubber dam isolation.

      Access cavity will be prepared with a fissure bur in a high-speed handpiece, necrotic pulp
      tissue will be removed using a sterile sharp spoon excavator.

      The canal orifices will be enlarged with a round bur (one mm diameter and two mm depth) to
      create medication receptacles.

      Cotton pellet moistened with 2.5% sodium hypochlorite (NaOCl) will be placed in the pulp
      chamber for 1 minute.

      Bleeding, if present, will be controlled by applying sterile cotton pellet moistened with 10%
      sodium hypochlorite against the pulp stumps and will be maintained for 1 min.

      The 3-Mix-Tatin will be mixed with saline to obtain a creamy mix and placed over the canal
      orifices and the pulpal floor.

      The access opening will be sealed with a glass ionomer cement , and the tooth will be
      restored with a stainless steel crown.
    

Intervention name(s): Calcium Hydroxide, Iodoform, paste; 3-mixtatin
Intervention type(s): Drug; Drug
Intervention description(s): mixture of calcium hydroxide and iodoform; 3-mixtatin mixture of ciprofloxacin, metronidazole, cefixime, and simvastatin
Other intervention name(s): metapex; 3mixtatin
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
A Comparison of Side Effects in Hypogonadal Men Treated With Natesto Versus Testosterone Injections
Condition: Hypogonadism, Male
MeSH terms: Hypogonadism; Eunuchism
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate changes in vascular parameters and the prevalence of
      side effects in subjects receiving 1 cc (200mg) every 2 weeks intramuscular (IM) of
      Testosterone Cypionate versus subjects receiving 11mg three times daily (TID) Natesto to
      participant with clinical hypogonadism.
    

Detailed description: 
      Administration of exogenous testosterone as efficacious treatment for male hypogonadism has
      been part of medical practice for more than 50 years. Testosterone replacement therapy (TRT)
      is becoming more widely available and has seen a greater than three-fold increase in use in
      men 40 years and older. Current delivery systems of TRT include transdermal gels and patches,
      intranasal gels (currently marketed as Natesto), injection therapy, and long acting
      subcutaneous pellets.

      Natesto is a short-acting formulation of testosterone delivered intranasally to men diagnosed
      with low T. This has the potential to avoid side effects related to TRT that are commonly
      seen with other delivery methods, namely polycythemia, acne, male-pattern hair loss,
      azoospermia and hyperestrogenemia.

      Testosterone Cypionate injections are the most common form of TRT in the USA. Testosterone
      Cypionate has many reported side effects, the most common being polycythemia, gynecomastia,
      hair loss, acne, decreased spermatogenesis, and testicular atrophy. In a multicenter
      retrospective study, it has been shown that the prevalence of polycythemia in men on
      testosterone replacement (injections) was 11.2%. In this study, we will compare hematocrit
      changes caused by treatment with Testosterone Cypionate and Natesto in a parallel arm,
      randomized study. To date, there have been no direct head-to-haed comparisons of these
      formulations.

      We hypothesize that the short-acting pharmacokinetics of Natesto more closely resembles the
      natural pulsatility of testosterone and therefore can avoid side effects traditionally seen
      in long-acting, exogenous testosterone formulations
    

Intervention name(s): Testosterone Cypionate 200 Mg/ML; Intranasal Testosterone
Intervention type(s): Drug; Drug
Intervention description(s): Participants in this group will receive intramuscular testosterone cypionate injections of 1 cc (200mg) once every 14 days for four months.; Participant in this group will receive Intranasal testosterone administered using a multi-dose dispenser, as two or three daily doses (5.5 mg per nostril, 11.0 mg single dose) for 4 consecutive months,
Other intervention name(s): Natesto
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Low T
Effect of Low-dose vs. High-dose Pitavastatin on In-stent Restenosis
Condition: Atherosclerosis; Neointima; Angina
MeSH terms: Atherosclerosis; Neointima
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare low dose (1mg) pitavastatin and high dose (4mg) pitavastatin on neointimal
      hyperplasia and atherosclerosis progression by using optical coherence tomography (OCT) and
      near-infrared spectroscopy (NIRS) at 12 months follow-up and on clinical adverse
      cardiovascular events during 3-year follow-up.
    

Detailed description: 
      -  Patients with non-ST elevation ACS will be randomized into pitavastatin 1mg or 4mg after
           everolimus-eluting stent implantation with OCT and NIRS study.

        -  12 months follow-up coronary angiography with OCT and NIRS will be performed to compare
           neointimal hyperplasia and atherosclerosis progression.

        -  36 months clinical follow-up for major adverse cardiovascular events (cardiac death,
           all-cause death, myocardial infarction, stroke, target lesion revascularization) will be
           compared.

        -  Safety issues such as bleeding rates, abnormal liver function will be compared
    

Intervention name(s): Pitavastatin 1mg; Pitavastatin 4mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia; To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia; To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia
Other intervention name(s): Livalo 1mg; Livalo 4mg
Intervention MeSH terms: Pitavastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Interventions to Improve Colorectal Cancer Screening
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      We will evaluate if we can increase colorectal cancer screening rates by directly sending
      screening tests to patients rather than waiting for them to come to clinic visits. We are
      also evaluating a new test--fecal immunochemical tests--which does not require patients to
      make dietary or medication changes. We will see if patients are more likely to complete these
      tests than the standard fecal occult blood tests.
    

Detailed description: 
      Background: Colorectal cancer causes a substantial burden of suffering in the elderly VA
      population. Although colorectal cancer screening can reduce both the incidence and mortality
      from colorectal cancer, screening rates are low for the New Mexico VA Health Care System.

      Objectives: We propose to use the electronic medical record and a new technology for fecal
      stool testing to improve screening rates and adherence to screening.

      Methods: The electronic medical record will be used to identify patients who are eligible for
      screening but who do not have an immediately upcoming primary care clinic appointment. We
      will enroll a randomly-selected sample of 800 of these patients who have agreed to
      participate in the study and mail them stool tests along with instructions and educational
      information about the benefits of screening. We will compare the proportion of subjects who
      undergo colorectal cancer screening during the 3-month study period against a
      randomly-selected sample of 400 eligible patients who will require a clinic visit to initiate
      screening. Because adherence for fecal occult blood tests is low, we also propose to evaluate
      a new screening technology--fecal immunochemical stool tests which target intact human
      hemoglobin. These tests can be performed without requiring patients to follow onerous dietary
      and medication restrictions. We will evaluate whether screening adherence (proportion
      completing testing) is higher with fecal immunochemical testing (n = 400) compared to the
      standard fecal occult blood test (n=400). We will also evaluate the yield of advanced
      neoplasia for each of the screening tests.
    

Intervention name(s): Mailed fecal occult blood tests; Mailed fecal immunochemical tests
Intervention type(s): Other; Other
Intervention description(s): Stool blood test; Stool blood test
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: screening
Effects on Immun System of Anesthesia
Condition: Anesthesia
Study type: Observational [Patient Registry]

Summary: 
      Introduction and Aim: Desflurane and sevoflurane are frequently used for maintenance of
      anesthesia and studies have shown that these anesthetics cause a variety of changes in
      oxidative stress and antioxidative defense mechanisms. The chemical structure of propofol is
      similar to some free radical consumers such as endogenous vitamin E and butylated hydroxene
      toluene. This study aims to compare the effects of sevoflurane, desflurane and propofol
      infusion anesthesia on the oxidant and antioxidant systems of patients undergoing
      laparoscopic cholecystectomy.

      Material and Method: Forty-five patients, ASA (American Society of Anesthesiologists) I-II,
      score between 18-50 years with planned laparoscopic cholecystectomy under general anesthesia
      were included in the study. Patients were divided into 3 groups as total intravenous
      anesthesia (TIVA) (group T n: 15), sevoflurane (group S n: 15) and desflurane (group D n:
      15). Propofol 2 mg/kg IV, fentanyl 1 mcg/kg IV, vecuronium 0.1 mg/kg IV given to all groups
      for anesthesia induction. For maintenance of anesthesia group S were ventilated with 2%
      sevoflurane, 50% air and 50% O2 mix at 6 L/min flow. Group D were given 6% desflurane 50% air
      and 50% O2 mix at 6 L/min flow. Group T were given propofol infusions of 12 mg/kg/hr for the
      first 10 minutes, 9 mg/kg/hr for the second 10 minutes and 6 mg/kg/hr after that. Patients
      were ventilated with 50% air and 50% O2 mix at 6 L/min flow. Before induction and after the
      operation venous blood samples were taken to evaluate the levels of glutathion peroxidase,
      total oxidants and antioxidants.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        45 patients ASA I-II between 18-50 years with planned laparoscopic cholecystectomy under
        general anesthetic were included in the study. Patients were divided into 3 groups on the
        way to surgery; TIVA (group T n: 15), sevoflurane (group S n: 15) and desflurane (group D
        n: 15).
      
Biospecimen description: 
      Before induction and after the operation venous blood samples were taken.
    
Keywords: Anesthesia; Oxidants; Antioxidants
Are Cesarean Section and Appendectomy in Pregnancy and Puerperium Interrelated?
Condition: Appendicitis Acute; Cesarean Wound Disruption With Postnatal Complication
MeSH terms: Appendicitis
Study type: Observational

Summary: 
      It is not known whether appendectomy for acute appendicitis (AA) increases the Cesarean
      section (CS) rate and whether CS increases the likelihood of AA and appendectomy in the early
      puerperium. In this study, delivery type and delivery outcomes and appendectomy during
      pregnancy and puerperium were analyzed.
    

Detailed description: 
      This cross-sectional retrospective study was performed on 11513 women, delivered during
      2015-2020. Inclusion criteria were patients submitted to appendectomy for AA during pregnancy
      and the first six weeks after delivery. Evaluating parameters were age, parity, gestational
      week at birth, delivery type, and babies' birth weight.
    

Intervention name(s): appendectomy
Intervention type(s): Procedure
Intervention description(s): appendectomy performance
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women who attended prenatal follow-up and delivered from October 1, 2015, to
        October 1, 2020.