bioihbjkbjnl/mcl2 huggingface dataset:
Gemcitabine and Radiation Therapy in Treating Patients With Cancer of the Pancreas
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Gemcitabine may
      make tumor cells more sensitive to radiation therapy. Combining chemotherapy with radiation
      therapy after surgery may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with radiation
      therapy in treating patients who have undergone surgery to remove cancer of the pancreas.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the time to disease progression, local control, and survival of patients with
           previously resected pancreatic cancer treated with adjuvant gemcitabine and
           radiotherapy.

      OUTLINE: This is a multicenter study.

      Patients receive gemcitabine IV over 30-60 minutes on days 1, 4, 8, 11, 15, 18, 22, 25, 29,
      and 32 and undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38 in the
      absence of disease progression or unacceptable toxicity.

      Beginning at least 4 weeks after chemoradiotherapy, patients without disease progression and
      with less than 10% weight loss during study receive additional gemcitabine IV over 30 minutes
      on days 1, 8, and 15. Treatment repeats every 28 days for a total of 2 courses.

      Patients are followed every 8 weeks for 6 months and then every 3 months for up to 2 years.

      PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 2.2 or 3.4
      years.
    

Intervention name(s): gemcitabine hydrochloride; adjuvant therapy; radiation therapy
Intervention type(s): Drug; Procedure; Radiation
Intervention MeSH terms: Gemcitabine
Primary purpose: Treatment
Keywords: stage I pancreatic cancer; adenocarcinoma of the pancreas
The Effect of Telerehabilitation-Based Exercise and Training on Outcome Measures in Patients With Knee Osteoarthritis
Condition: Osteoarthritis; Knee Arthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Video exercise component of the telerehabilitation would provide additional contribution to
      the patients. The aim of this study is to compare the effects of telerehabilitation-based
      exercise program and conventional (given on paper) exercise and training combination
      practices on pain, functionality, balance, proprioception and quality of life in patients
      with knee OA.
    

Detailed description: 
      Owing to telerehabilitation, exercise video suppliment will enable individuals to learn the
      exercise programs in the most appropriate way, have comprehensive information about their
      condition, and communicate easily with their physiotherapists. The aim of this study is to
      compare the effects of telerehabilitation-based exercise program and conventional (given on
      paper) exercise and training combination practices on pain, functionality, balance,
      proprioception and quality of life in patients with knee OA.
    

Intervention name(s): Telerehabilitation; Paper Based Rehabilitation
Intervention type(s): Other; Other
Intervention description(s): Application based video home exercise for the knee osteoarthritis; Paper instruction based home exercise for the knee osteoarthritis
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gonarthrosis; Knee Osteoarthritis
A Study to Evaluate a Leukapheresis Treatment in Patients With Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether a treatment of a novel leukapheresis column
      is safe and effective in patients with moderate to severe ulcerative colitis.
    

Detailed description: 
      Ulcerative colitis (UC) is a chronic and relapsing disease and is characterized by
      superficial inflammation in the colonic epithelium. The inflammation is maintained by
      continuous supply of inflammatory cells from the circulating blood to the intestinal mucosa.

      Existing therapy e.g. corticosteroids and immunosuppressants are inadequate with an overall
      long-term remission rate of only 50-60%. Those treatments are also associated with severe
      side effects why there is a need of new therapies.

      The aim of this study is to investigate a novel leukapheresis treatment with the potential to
      reduce the number of inflammatory cells homing to the gut mucosa. By drawing blood from the
      patient and pass it through the investigational column the inflammatory cells are removed.
      The blood, depleted of the inflammatory cells, is returned to the patient.

      The treatment thus enable down-regulation of the inflammation and consequently the
      inflammation can heal. The treatment is called Tailored leukapheresis.
    

Intervention name(s): Active TLA Gut™ column; Placebo
Intervention type(s): Device; Device
Intervention description(s): Five consecutive treatment sessions. The therapy will be administrated every second day.; Five consecutive treatment sessions. The placebo therapy will be administrated every second day.
Other intervention name(s): TLA Gut™
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ulcerative colitis; leukapheresis treatment
Effects of Macrolides on Asthma Control
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      Asthma is a common disease in Westernised societies, affecting up to 10% of the population.
      Corticosteroids are the most effective treatment for asthma but the therapeutic response
      varies considerably between individuals. A major cause of corticosteroid insensitivity in
      asthma is cigarette smoking. Active cigarette smoking occurs in over 25% of adults with
      asthma and a further 25% are ex-smokers. In a series of proof of concept clinical studies the
      investigators demonstrated for the first time that the efficacy of inhaled and oral
      corticosteroids is markedly impaired in smokers with asthma and to a lesser extent in
      ex-smokers with asthma. Active cigarette smoking has other detrimental effects on asthma
      morbidity including more severe symptoms, increased rates of hospitalisation, and accelerated
      decline in lung function. Smoking cessation advice is often ineffective because many adult
      smokers with asthma do not believe that they are personally at risk from their smoking, take
      many years until stopping smoking and frequently restart smoking after quitting. Alternative
      or additional drugs to corticosteroids are needed for smokers with asthma who are unable to
      obtain the clinical benefits associated with stopping smoking. In a proof of concept clinical
      trial the investigators will test the hypothesis that macrolides improve asthma control and
      reduce sputum neutrophil counts of smokers with chronic asthma.
    


Intervention name(s): Azithromycin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Daily dose 250mg; Placebo
Intervention MeSH terms: Azithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Smoker; Macrolide
A Study to Evaluate the Pharmacokinetics and Safety of Levofloxacin in Patients With Varying Degrees of Renal Function.
Condition: Renal Diseases
MeSH terms: Kidney Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective was to evaluate the pharmacokinetics and safety of two dosing regimens
      of levofloxacin in patients with varying degrees of renal function.
    

Detailed description: 
      In this multiple-dose study conducted at 4 centers, the pharmacokinetics of two dosing
      regimens of levofloxacin were assessed in medically stable men and women with varying degree
      of renal function. The study consisted of a 21 day pretreatment screening phase, a 7-day open
      label treatment phase, and a 7 day posttreatment phase (or a follow-up phase for subjects
      with early study withdrawal). Patients were randomized into 1 of 10 treatment groups, for a
      total of 6 patients per group, based on degree of renal function to ensure that creatinine
      clearance values within each group represented the full range of values defined in the Food
      and Drug Administration's (FDA) 1998 guideline for pharmacokinetic studies in patients with
      impaired renal function. Fifty-nine patients were enrolled in the study. All patients
      received a single 750-mg dose of levofloxacin on Day 1; subsequent doses of either 250, 500,
      or 750 mg of levofloxacin (q24h or q48h) were based on renal function. Blood samples were
      collected from each patient from Day 1 to Day 14 for pharmacokinetic evaluation. Urine was
      collected on Days 1 and 7 before dosing and over specific time intervals up to 24 or 48 hours
      postdosing depending on the patient's dosing regimen. Dialysate samples were collected on Day
      7 from HD patients immediately before dosing (as dialysis began) and at the end of the
      dialysis treatment. Patients were confined overnight at the study unit on Days 0, 1, 6, and
      7, and remained confined until the 24 hour blood samples were collected on Days 2 and 8.
      Safety was based on the incidence, relationship to therapy, and severity of
      treatment-emergent adverse events and on changes in clinical laboratory values (hematology,
      chemistry, and urinalysis), vital sign measurements, electrocardiograms (ECGs), and physical
      examination findings. Single 750-mg dose of levofloxacin on Day 1; subsequent doses of
      Levofloxacin 250 milligram (mg), 500 mg, and 750 mg tablets administered every 24 hours for 7
      days or every 48 hours for 7 days
    

Intervention name(s): Levofloxacin
Intervention type(s): Drug
Intervention MeSH terms: Levofloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: renal diseases; levofloxacin
Lung Deposition of the BDP/Formoterol Combination Administered Via the NEXT DPI in Healthy, Asthmatic and COPD Patients
Condition: Pulmonary Disease, Chronic Obstructive; Asthma
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to investigate the lung deposition and distribution pattern of
      Beclometasone and Formoterol using a gamma-scintigraphic technique after inhalation of a
      single dose of 99mTc-radiolabelled BDP/formoterol fixed combination administered Via the NEXT
      DPI in healthy volunteers, asthmatic and COPD patients. Additionally, the systemic exposures
      to formoterol, BDP and its monopropionate metabolite (B17MP) will be investigated.
    


Intervention name(s): BDP/formoterol NEXT DPI
Intervention type(s): Drug
Intervention description(s): Single inhalation of radiolabelled BDP/formoterol 100/6 µg NEXT DPI (4 puffs giving a total dose of 400 µg BDP + 24 µg formoterol)
Other intervention name(s): CHF 1535 NEXT DPI
Intervention MeSH terms: Formoterol Fumarate
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prone Flexed Position in Percutanous Nephrolithotomy
Condition: Renal Stones
MeSH terms: Kidney Calculi; Nephrolithiasis
Study type: Interventional

Summary: 
      prone flexed position in percutanous nephrolithotomy in comparsion with standard prone
      position. A randomized controlled trial.
    

Detailed description: 
      Patients meeting the inclusion criteria will be randomly allocated to 2 groups:

        1. 1st group will undergo prone-flexed PCNL.

        2. 2nd group will undergo prone PCNL.

      III. Recruitment of participants Patients appointed for an outpatient diagnostic cystoscopy
      will be reviewed for the inclusion and exclusion criteria. Legible patients will be asked to
      participate in the study and to sign the informed consent form.

      IV. Randomisation Randomization will be performed using computer generated random tables
      using stratified blocked randomization in 1:1 ratio.

      V. Study procedure Preoperative evaluations included

        1. Detailed medical history

        2. Physical examination

        3. Routine blood examination

        4. Urinalysis & urine cytology

        5. Renal and liver function tests

        6. Coagulation profile

      8. Computed tomography of the abdomen and pelvis

      Operative Technique

      Prone-flexed positioning i. Retrograde access will be obtained ii. The patient is
      repositioned prone with adequate padding under the pressure points of the head, chest, knees,
      and feet.

      iii. The table is flexed 30 degrees at the level of the patient's mid lumbar region to open
      the space between the 12th rib and the posterior iliac crest dropping the gluteal muscles
      from the working plane.

      Ancillary intervention

      Patients will receive a 20-mL infiltration of 0.25% bupivacaine. Under fluoroscopic guidance,
      the local analgesic was infiltrated with a 22-gauge spinal needle (10-cm length) along the
      nephrostomy tract at the 3, 6, 9, and 12 o'clock positions (5 mL in each tract), including
      the muscles, subcutaneous tissue, and skin.

      Patients will receive 1 g tranexamic acid at induction followed by three further doses of 500
      mg over the next 24 h.
    

Intervention name(s): Percutanous nephrolithotomy (PCNL)
Intervention type(s): Procedure
Intervention description(s): different procedure positioning
Other intervention name(s): PNL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Method-of-Use Study Assessing the Effect of Naltrexone Sustained Release (SR)/ Bupropion SR on Body Weight and Cardiovascular Risk Factors in Overweight and Obese Subjects
Condition: Obesity; Overweight
MeSH terms: Overweight; Body Weight
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this Phase 3b study is to assess the effects of combination therapy with
      naltrexone SR/bupropion SR (NB) used in conjunction with a comprehensive lifestyle
      intervention (CLI) and in a manner consistent with its intended use after marketing approval,
      on body weight and cardiovascular risk factors compared to the effects of Usual Care in
      subjects who are overweight with dyslipidemia and/or controlled hypertension or obese.
      Subjects in the NB and CLI group are required to undergo an evaluation to continue treatment
      at Week 16. Subjects are to be discontinued from full participation if they do not lose at
      least 5% of their body weight relative to baseline and/or are experiencing sustained
      increases in blood pressure (systolic or diastolic) of ≥10 mmHg above baseline. At Week 26,
      subjects originally assigned to Usual Care switch to treatment with NB and CLI, and subjects
      assigned to NB and CLI continue treatment for the duration of the study (78-weeks treatment
      period).
    


Intervention name(s): NB; CLI; Usual Care
Intervention type(s): Drug; Behavioral; Behavioral
Intervention description(s): Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage); The Comprehensive Lifestyle Intervention (CLI) program includes telephone counseling, internet education, goal setting, and online tracking tools.; Usual Care is a self-directed lifestyle intervention program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity, overweight
Therapy of Obesity and Diabetes Mellitus Type 2
Condition: Obesity; Diabetes Type 2; Weight Loss
MeSH terms: Diabetes Mellitus; Obesity; Diabetes Mellitus, Type 2; Weight Loss
Study type: Interventional

Summary: 
      To evaluate a standardized weight-loss program as treatment option for obesity and type 2
      diabetes, changes in body composition and metabolic control are investigated in obese
      patients with diabetes.
    

Detailed description: 
      Men and women with obesity and diabetes mellitus type 2 are invited to join a standardized
      weight-loss program (six weeks of formula diet, followed by the reintroduction of regular
      food with gradually increasing energy intake over nine weeks) for a duration of 15 weeks. All
      subjects undergo bioelectrical impedance analyses to investigate body composition and magnet
      resonance imaging to measure fat mass and fat fractions of abdominal organs, at three time
      points: first before the program, then at the end of the six weeks of formula diet and
      finally, at the end of the program after 15 weeks. Laboratory data are measured before and
      after the program.
    

Intervention name(s): Structured weight-loss program
Intervention type(s): Other
Intervention description(s): During the fasting phase, daily consumption consists of five sachets fully replacing normal food and corresponded to an energy content of 800 kcal. This fasting phase is followed by a four-week refeeding phase, during which regular food will be reintroduced and formula diet is gradually replaced until a daily total intake of 1200 kcal is reached. During the last five weeks of the program, energy intake is gradually increased to an individual level between 1200 kcal and 1500 kcal that allowed subjects to keep their weight stable.
Once a week participants visit the study center to monitor health status and taking part in supervised exercises and a nutritional and behavioral counseling.
Other intervention name(s): OPTIFAST II Short Program
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Formula diet
Ocular Pharmacokinetics After a Single Drop Instillation of T1225 0.5, 1, 1.5% in 91 Healthy Volunteers
Condition: Eye Infections, Bacterial
MeSH terms: Bacterial Infections; Eye Infections; Eye Infections, Bacterial
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate azithromycin tear concentrations after instillation of one drop of one of the
      three T1225 concentrations (0.5%, 1% and 1.5%) and to evaluate the ocular safety.
    

Detailed description: 
      The aim of the present study was to compare azithromycin tear ocular concentrations after a
      single instillation of three different T1225 concentrations in order to determine early
      azithromycin tear concentration and to assess the T1225 concentration, which allowed having
      the higher azithromycin tear concentration, 24 hours after a single instillation.
    

Intervention name(s): Azithromycin
Intervention type(s): Drug
Intervention MeSH terms: Azithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Effect of Omega-3 Fatty Acid on Endothelial Function
Condition: Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      Background

      Familial hypercholesterolemia (FH) is an inherited disease in which the level of bad
      cholesterol (LDL-cholesterol) is increased, leading to an increase in coronary heart disease
      even if adequately treated with cholesterol lowering medication (statins). Polyunsaturated
      fatty acids (PUFA) including omega-3 is known to affect the risk for coronary disease,
      however its effect on patients with FH is not known.

      The purpose of the study is to assess the effect of PUFA on patients with FH, with regard to
      inflammation measured in the blood and the effect on the blood vessels'ability to relax
      (endothelial function) by means of tonometry.

      Hypothesis

      Treatment with 4 grams of PUFA a day for 4 months will lead to an improvement in the
      endothelial function, and the treatment will also lead to a decrease in in several markers of
      inflammation and in lipids in the blood.
    


Intervention name(s): Omega-3; placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Omacor; olive oil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Verubulin, Radiation Therapy, and Temozolomide to Treat Patients With Newly Diagnosed Glioblastoma Multiforme
Condition: Glioblastoma Multiforme
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This, international, multi-center, Phase 2 study of verubulin will be conducted in patients
      with newly diagnosed Glioblastoma Multiforme (GBM). The study will be conducted in two parts.
      Part A is an open-label dose finding study that will determine the safety and tolerability of
      verubulin in combination with standard treatment. Part B is a randomized open-label study
      that will investigate progression-free survival and overall survival of patients receiving
      verubulin, at the dose determined in Part A, in combination with standard treatment versus
      standard treatment alone.
    


Intervention name(s): Verubulin; Temozolomide & Radiation Therapy
Intervention type(s): Drug; Drug
Intervention description(s): Verubulin, dose determined in Part A, i.v. once weekly, Temozolomide & Radiation Therapy; Temozolomide & Radiation Therapy
Other intervention name(s): Azixa; MPC-6827; Temodar; TMZ; Radiotherapy
Intervention MeSH terms: Temozolomide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glioblastoma; Brain Neoplasms; Brain Cancer; Verubulin