bioihbjkbjnl/mcl2 huggingface dataset:
Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver
Condition: Colorectal Cancer; Metastatic Cancer
MeSH terms: Colorectal 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. Giving drugs in different ways may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of liver perfusion using oxaliplatin plus
      leucovorin and fluorouracil given by infusion in treating patients who have colorectal cancer
      that has spread to the liver.
    

Detailed description: 
      OBJECTIVES: I. Determine the efficacy and tolerance of oxaliplatin by hepatic perfusion
      combined with intravenous leucovorin calcium and fluorouracil in patients with liver
      metastases from colorectal cancer.

      OUTLINE: Patients receive oxaliplatin by hepatic perfusion over 2 hours on day 1 plus
      leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 1 and 2.
      Treatment repeats every 14 days in the absence of disease progression or unacceptable
      toxicity. If a good response is achieved after 8 courses of chemotherapy, patients may
      undergo surgical resection of metastases.

      PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
    

Intervention name(s): FOLFOX regimen; fluorouracil; isolated perfusion; leucovorin calcium; oxaliplatin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Leucovorin; Fluorouracil; Oxaliplatin; Calcium; Levoleucovorin
Primary purpose: Treatment
Keywords: stage IV colon cancer; stage IV rectal cancer; liver metastases
Effect of Early Rehabilitation on Recovery Following Abdominal Hysterectomy
Condition: Post-Op Complication
MeSH terms: Postoperative Complications
Study type: Interventional

Summary: 
      Variety of physical therapy treatments have been used after open abdominal surgery to improve
      cardiopulmonary and physical function as well as to reduce the incidence of postoperative
      pulmonary complications. This study intends to determine the effect of early physical therapy
      interventions on post-operative recovery profile, post-operative ileus and incisional pain
      following abdominal hysterectomy.
    

Detailed description: 
      This study is randomized controlled trial which will be conducted at in-patient gynecology
      department of Pakistan Railway hospital. This study would include total of 42 participants
      divided into two groups with 21 participants in each group calculated through OpenEpi
      (CI=95%Power=80%). Individuals will be screened according to inclusion and exclusion criteria
      and allocated randomly into two groups through sealed envelope method. Experimental group
      will receive early physical therapy interventions including patient education, ambulation,
      in-bed exercises, deep breathing exercises, connective tissue manipulation and TENS during
      the first 3 post-operative days following abdominal hysterectomy. While the control group
      will receive patient education and early ambulation during the first 3 post-operative days
      following abdominal hysterectomy.

      Post-operative recovery will be assessed on 3rd post-operative day. Intensity of pain will be
      measured on baseline and 3rd post-operative day. The effect of intervention on post-operative
      ileus will be measured by monitoring each participant's time to tolerance of oral diet, first
      passage of stool and flatus
    

Intervention name(s): Advanced early Rehabilitation Program; Early ambulation
Intervention type(s): Other; Other
Intervention description(s): Patient education, Ambulation, In bed exercises, Deep breathing exercises: (5 rep x 3set), Connective tissue manipulation for intestinal motility (5 min) and TENS* for incisional pain (30min); Patient education & Assisted ambulation out of bed including walking away from bedside for at least 15 min gradually moving to Unsupervised ambulation for 30 min
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Both experimental and control groups will be treated at the same time following their respective protocols
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Abdominal hysterectomy; postoperative pain; Early rehabilitation; Postoperative recovery profile
Pentoxifylline and Late Onset Sepsis in Preterm Infants
Condition: Neonatal Late Onset Sepsis
MeSH terms: Sepsis; Toxemia; Neonatal Sepsis
Study type: Interventional
Phase: Phase 3

Summary: 
      -  Hypothesis: The investigators hypothesized that Pentoxifylline has potent
           anti-inflammatory effect which can augment the antimicrobial effect of antibiotics in
           treatment of Late onset sepsis (LOS) in preterm infants thus decreasing neonatal
           mortality and morbidity.

        -  The purpose of this study: to assess the efficacy and safety of Pentoxifylline as an
           adjunct to antibiotic therapy on mortality and morbidity of preterm infants with LOS.
    

Detailed description: 
      -  Role of pentoxifylline, a phosphodiesterase inhibitor, in reducing mortality associated
           with neonatal sepsis is not well studied.

        -  Hypothesis: we hypothesized that Pentoxifylline has potent anti-inflammatory effect
           which can augment the antimicrobial effect of antibiotics in treatment of Late onset
           sepsis (LOS) in preterm infants thus decreasing neonatal mortality and morbidity.

        -  Purpose of the study: to assess the efficacy and safety of Pentoxifylline as an adjunct
           to antibiotic therapy on mortality and morbidity of preterm infants with LOS.

        -  Design: A prospective, randomized, double-blind clinical trial.

        -  Setting: Neonatal Intensive Care Unit, Mansoura University Children's Hospital.

        -  Patients: 120 preterm infants with suspected or confirmed LOS.

        -  Intervention: Enrolled infants were randomly assigned to receive intravenous
           Pentoxifylline (5 mg/kg/hr for 6 hours on 6 successive days) or placebo in addition to
           antibiotics.

        -  Primary outcome: Death before hospital discharge.

        -  Secondary outcomes: Length of hospital stay, duration of respiratory support, duration
           of antibiotics use, chronic lung disease, necrotizing enterocolitis, intraventricular
           hemorrhage, periventricular leukomalacia, retinopathy of prematurity, Serum levels of
           Tumor necrosis factor, C-Reactive protein levels, and adverse effects of Pentoxifylline.
    

Intervention name(s): Pentoxifylline (PTX); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients were randomly assigned to receive intravenous Pentoxifylline 5 mg/kg/hr for 6 hours on 6 successive days in addition to antibiotics; Patients were randomly assigned to receive intravenous normal saline 5 mg/kg/hr for 6 hours on 6 successive days as a placebo in addition to antibiotics.
Other intervention name(s): Trental (brand name)
Intervention MeSH terms: Pentoxifylline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: neonatal; pentoxifylline; randomized controlled trial
Optimization of Antiretroviral Therapy
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The combination antiretroviral therapy (cART) inhibit HIV replication effectively. However,
      synergy among these drugs has not been well considered. The dose of drugs used as monotherapy
      is the same as that used in combination therapy. Tenofovir+lamivudine+efavirenz is still the
      first line regimen of cART in developing countries. The side effects of these drugs are
      related to the concentration of drugs. Based on our previous data, we aim to evaluate whether
      reduce the dose of tenofovir and efavirenz could decreasing the incidence of the side effects
      while not scarifying their virological efficacy.
    


Intervention name(s): Tenofovir disoproxil fumarate; Lamivudine; Efavirenz
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral daily; Oral daily; Oral daily
Intervention MeSH terms: Tenofovir; Lamivudine; Efavirenz
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cardiovascular Autonomic Control Evaluation Through Cardiac Frequency Variability in Hypertensive Patients
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Analyzing cardiovascular evaluation measures in the multidisciplinary and in the conventional
      treatment of hypertensive patients will provide better parameters for comparing the two
      approaches.
    


Intervention name(s): Multidisciplinary assistance; Conventional treatment and follow up
Intervention type(s): Other; Other
Intervention description(s): Multidisciplinary group assistance was effected every two months by all professionals (physician, nurse, dietitian, physiotherapist and psychologist) and consisted in orientations and mechanisms to medication and non-pharmacological adherence (lifestyle changes).; Assistance was effected by physician and nurse and consisted about adapting to the drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cardiac Frequency Variability; multidisciplinary care; clinical trial
Safety and Tolerability of Seroguard Use
Condition: Adhesion
MeSH terms: Tissue Adhesions
Study type: Interventional
Phase: Phase 1

Summary: 
      The performed study of safety and tolerability of Seroguard, solution (JSC Pharmasyntez,
      Russia) in patients, undergoing planned laparoscopic cholecystectomy, demonstrated that
      patients from the both groups had the similar safety profile
    

Detailed description: 
      The present study was conducted as multicenter, randomized, double-blind, parallel group
      clinical study. After successful completion of screening procedures, patient underwent a
      planned laparoscopy. Randomization of patients into groups was performed on the day of
      surgery using envelops. The test drug or the placebo were used at the completion stage of
      surgery. Monitoring of patient on inpatient basis was performed for 6 days after completion
      of surgery. Discharge of patient from the hospital with no contraindications was possible on
      Day 7 of the study. In this case the follow-up of patient was performed on outpatient basis.
      Follow-up was performed for 4 weeks before Day 28 of the study. Study procedures aimed at
      evaluation of safety and tolerability of using the test drug or the placebo were identical in
      main and control groups.
    

Intervention name(s): Seroguard; Placebos
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: laparoscopic cholecystectomy
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Adhesion; Safety
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of QAX576 in Asthma Patients
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is designed to investigate the safety and tolerability of multiple doses of QAX576
      in controlled or partially controlled asthma patients.
    


Intervention name(s): QAX576; QAX576; QAX576; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Asthma
Effect of Ulnar Styloid Fracture on the Outcome of Distal Radial Fractures Treated With External Fixation
Condition: Fracture of Distal End of Radius; Fracture of Ulnar Styloid
MeSH terms: Fractures, Bone
Study type: Observational [Patient Registry]

Summary: 
      Untreated ulnar styloid fracture may affect the outcomes of distal radial fracture patient
      treated with external fixation.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        unstable distal radial fracture patients: (1) the initial dorsal angulation >20°, (2) with
        dorsal or volar comminution of the metaphysis, (3) shortening of radius >5 mm, and (4) with
        an associated ulnar fracture.
A Study to Determine the Effect of a High-Fat Meal on the Rate and Extent of E2006 Absorption in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single-dose, randomized crossover study of single oral 10-mg tablet
      doses administered either after an overnight fast or in combination with a standard high-fat
      meal in healthy subjects.
    

Detailed description: 
      The study will have 2 phases: Prerandomization and Randomization. The Prerandomization Phase
      will consist of 2 periods: Screening and Baseline (Baseline Period 1), during which each
      subject�s study eligibility will be determined and baseline assessments will be conducted.
      During this phase, each eligible subject will be randomized to 1 of 2 treatment sequences to
      receive single oral doses of E2006 10 mg under fasted and fed conditions. The Randomization
      Phase will consist of 3 periods: administration of the first randomized dose (Treatment
      Period 1), baseline for the second randomized dose (Baseline Period 2), and administration of
      the second randomized dose (Treatment Period 2).
    

Intervention name(s): E2006
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Subjects; Absorption; High-Fat Meal
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ION547
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of single and multiple
      doses of the antisense inhibitor ION547 administered subcutaneously (SC) in healthy
      participants.
    

Detailed description: 
      This is a Phase 1, double-blind, randomized, placebo-controlled, dose escalation study of
      ION547 in up to 76 participants. Participants will be randomized to receive single and
      multiple doses of ION547 or placebo SC. The maximum length of participation in the study will
      be approximately 34 weeks.
    

Intervention name(s): ION547; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ION547 will be administered by SC injection.; ION547-matching placebo will be administered by SC injection.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy Participants
Clinical Factors Associated Floppy Iris
Condition: Pupil Constriction; Iris Floppiness; Iris Prolapsus From the Wound
MeSH terms: Miosis; Constriction, Pathologic
Study type: Observational

Summary: 
      This study is planned to investigate the incidence of intraoperative floppy iris and its
      relationship with pseudoexfoliation, diabetes, hypertension as well as systemic alpha-1
      adrenergic blocker use.
    

Detailed description: 
      Our aim is to investigate the incidence of intraoperative floppy iris syndrome (IFIS) signs
      and evaluate the relationship of IFIS signs as well as complete IFIS with pseudoexfoliation,
      diabetes, hypertension, and alpha-1 adrenergic blocker (A1AB) use. Five-hundred patients will
      be included in this prospective study. Preoperatively, pupil diameter before and after
      dilation, presence of pseudoexfoliation, history of diabetes, hypertension, and use of any
      A1AB will be recorded. Intraoperative adverse events such as pupillary constriction, iris
      billowing, and iris prolapse from the wound will be noted. Multinomial regression analysis
      will be used to evaluate the relationship of IFIS signs with pseudoexfoliation, diabetes,
      hypertension, and A1AB usage. According to the results we will determine the incidence of
      IFIS in our patient population and evaluate its relationship with alpha-1 adrenergic blocker
      use. We will also investigate the relationship of floppy iris problems with
      pseudoexfoliation, diabetes, high blood pressure.
    

Observational model: Defined Population
Time perspective: Other
Keywords: Alpha-adrenergic blockers; cataract surgery; pseudoexfoliation syndrome; diabetes mellitus; hypertension; pupil
Lantus Versus NPH: Comparison in Insulin Naive People Not Adequately Controlled With at Least One Oral Anti Diabetics (OAD) Treatment
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

      To demonstrate the superiority of insulin glargine over insulin NPH (Neutral Protamin
      Hagedornon) the change in HbA1c from baseline to the end of the treatment period.

      Secondary Objective:

      To compare between treatment groups:

        -  Plasma glucose (fasting, nocturnal) over time,

        -  Changes from baseline in HbA1c over time,

        -  Percentage of patients who reach the target of HbA1c <7 and <6.5,

        -  Use of prandial insulin as rescue medication at month 6,

        -  Incidence and rate of hypoglycemia (symptomatic diurnal and nocturnal, asymptomatic and
           severe),

        -  Daily dose of insulin,

        -  Change in body weight from baseline,

        -  Evolution of 8-point plasma-glucose (PG) profiles,

        -  Overall safety,

        -  Patient reported outcomes (treatment satisfaction).
    


Intervention name(s): Insulin Glargine (HOE901) [Lantus]; Glimepiride; human insulin [NPH]
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100 Units/ml solution for injection in a pre-filled pen SoloStar® (3 ml); tablets of 1 and 2 mg; 100 IU/ml suspension for injection in a prefilled pen OptiSet® (3 ml)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Glimepiride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Speech-therapy in Hypertensive Patients
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Anthroposophic speech therapy (ATS) has been shown to positively influence heart rate
      variability (HRV) and heart rate - respiration coordination in healthy volunteers. This study
      was performed to learn more about such improvements and possible alteration in baroreflex
      sensitivity (BRS) in hypertensive patients, which characteristically differ in those
      regulatory parameters from normotensive patients
    

Detailed description: 
      In this prospective, primarily pre-post study, patients received three ATS treatments in
      alternation with three control sessions (casual talking with the therapist). In order to
      perform HRV-analysis and BRS determination blood pressure and ECG were continuously recorded
      during the sessions. Changes in subjective well-being and perceived health were assessed by
      questionnaire before and after the various sessions (mood questionaire).

      Thirty-one patients participated in this study, the majority diagnosed with arterial
      hypertension (22 out of 31).
    

Intervention name(s): Anthroposophic speech therapy
Intervention type(s): Behavioral
Intervention description(s): Anthroposophic speech therapy uses sound-combinations like "KLSFM" or "OM" and hexameter verse in German, spoken by the therapist and imitated by the patients, to expand and decelerate respiration. The intervention is conducted by the same qualified therapist for one patient in different days but during the same daytime for 30 minutes in upright position and walking.
Other intervention name(s): Speech guided breathing therapy
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Traditional Dietary Advice Versus a Low FODMAP Diet Intake in IBS Patients
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to to assess if the new diet with a low-FODMAP(Fermented Oligo-,
      Di-, Monosaccharides And Polyols) -content yields a milder symptom picture in IBS patients
      compared to traditionally dietary advice in IBS. The study also aim to investigate patients
      compliance to either dietary advices. Further, the investigators aim to find out if IBS
      patients with different symptoms are alleviated in different ways, to be able to
      individualize the dietary advices to result in a more optimal symptom relief in each patient
      in the future.
    


Intervention name(s): Diet A i.e. Low FODMAP diet; Diet B, i.e. Traditional IBS diet
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Defecation; Abdominal pain
An Efficacy, Safety, and Pharmacokinetics Study of JNJ-56136379 in Participants With Chronic Hepatitis B Virus Infection
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Virus Diseases; Herpesviridae Infections; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this study is to evaluate efficacy of 24 weeks of study treatment, in
      terms of changes in hepatitis B surface antigen (HBsAg) levels.
    

Detailed description: 
      The main study consists of 2-parts and each part will consist of 2 types of Chronic Hepatitis
      B-infected participant populations. Each part of the study will consist of screening phase
      (up to 8 weeks), treatment phase (24 weeks or 48 weeks, depending on treatment response), and
      post-treatment follow-up phase (24 weeks or 48 weeks, depending on treatment response). The
      duration of individual participation will be up to approximately 56 weeks (participants not
      eligible to continue treatment in extension phase), up to 80 weeks (participants continuing
      treatment in extension phase but not meeting treatment completion criteria), or up to 104
      weeks (participants meeting treatment completion criteria). The safety and efficacy will be
      monitored throughout the study. In a separate substudy, at selected clinical sites,
      percutaneous core liver biopsy will be performed to evaluate changes of intrahepatic viral
      parameters.
    

Intervention name(s): JNJ-56136379; Placebo; NA (ETV or TDF)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive JNJ-56136379 tablet orally.; Participants will receive matching placebo tablet orally.; Participants will receive NA (ETV or TDF) tablet orally as per approved label.
Other intervention name(s): JNJ-6379
Intervention MeSH terms: JNJ-56136379
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment