bioihbjkbjnl/mcl2 huggingface dataset:
A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Hypofractionation Radiotherapy in High-risk Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy and toxicities of hypofractionation
      radiotherapy with conventional fractionation radiotherapy in breast cancer patients treated
      with mastectomy.It is hypothesized that the efficacy and toxicities are similar between the
      two groups.
    

Detailed description: 
      Eligible breast cancer patients with mastectomy and axillary dissection are randomized into 2
      groups:conventional fractionation radiotherapy of 50 Gy in 25 fractions within 5 weeks to
      ipsilateral chest wall and supraclavicular nodal region,and hypofractionation radiotherapy of
      43.5Gy in 15 fractions within 3 weeks to the same region.

      During and after radiotherapy, the patients are followed and the efficacy and toxicities of
      radiotherapy are evaluated.
    

Intervention name(s): hypofractionation radiotherapy; conventional fractionation radiotherapy
Intervention type(s): Radiation; Radiation
Intervention description(s): radiotherapy of 43.5Gy/15f/3w to the chest wall and supraclavicular nodal region; 50Gy/25/f/5w
Other intervention name(s): radiotherapy; radiotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: breast cancer; mastectomy; radiotherapy; fractionation
Comparison of the Effectiveness of Functional Training Versus Resistance Exercises in Patients With Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Study type: Interventional

Summary: 
      The aim of this study was to assess the effectiveness of Functional training versus
      resistance training in improving functional capacity, muscle strength, quality of life and
      disease activity in patients with PSA.
    

Detailed description: 
      The Functional Training Group (FT) used elastic bands and the Resistance Exercise Group (RE)
      used weight training machines. The FT patients performed functional training and RE performed
      resistance exercises for the following muscles group: upper limbs, lower limbs and trunk. It
      was used a machine "leg extension" for the training on the lower limbs. For upper limbs the
      investigators used a pulley triceps machine and front pull in addition to free weights
      (dumbbells).

      In order to perform the exercise program, the study followed all the recommendations
      established by the American College of Sports Medicine (ACSM) (Ratamess et al., 2009). It was
      carried out two exercises for major muscle groups and one exercise for small muscles. The
      exercises were divided in 3 sets of 12 repetitions for each muscle group. The intensity of
      the exercises was 60% of one-maximum repetition (1RM).

      The exercise program involved pectoral exercises: crucifix and seat supine; biceps:
      alternated screw; triceps: triceps pulley; back: standing handsaw and pulled ahead;
      quadriceps: leg extensor and finally gluteus: standing hips extension.

      The patients were instructed to maintain their daily activities and to avoid any other
      nonpharmacological treatment.
    

Intervention name(s): Resistence Exercise
Intervention type(s): Other
Intervention description(s): Underwent resistance exercise twice a week, for twelve weeks for the following muscles group: upper limbs, lower limbs and trunk.
It was carried out two exercises for major muscle groups and one exercise for small muscles. The exercises were divided in 3 sets of 12 repetitions for each muscle group. The intensity of the exercises was 60% of one-maximum repetition (1RM).
The exercise program involved pectoral exercises: crucifix and seat supine; biceps: alternated screw; triceps: triceps pulley; back: standing handsaw and pulled ahead; quadriceps: leg extensor and finally gluteus: standing hips extension.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Functional training; Physical exercise; Psoriatic arthritis; Quality of life
A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy, safety, and tolerability of adjunctive ALKS 5461 in
      adults who have treatment refractory MDD.
    


Intervention name(s): ALKS 5461; ALKS 5461 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Samidorphan + buprenorphine, administered sublingually; Placebo tablet, administered sublingually
Intervention MeSH terms: Naltrexone; Buprenorphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alkermes; Major Depressive Disorder; Treatment Refractory MDD; ALKS 5461
Does Rosuvastatin Delay Progression of Atherosclerosis in HIV
Condition: HIV; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Atherosclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a randomised double blind placebo controlled trial comparing Rosuvastatin with
      placebo in HIV positive people who are at intermediate cardiovascular risk.

      It is possible that HIV positive people will receive a greater benefit from statins because
      of their higher baseline levels of inflammation. Current Australian guidelines recommend
      initiation of statin therapy on the basis of cholesterol level and the presence of other risk
      factors for heart disease (such as diabetes) but do not take into account whether a patient
      is infected with HIV. This study aims to determine what benefit HIV infected people will
      receive from starting statin therapy earlier then currently recommended.
    

Detailed description: 
      Participants will be randomised to receive either the active agent (Rosuvastatin) or a
      placebo once daily for 96 weeks.

      Participants will undergo blood tests and ultrasounds of the arteries of the neck (carotid
      intima media thickness) prior to starting Rosuvastatin and then after 1 and 2 years on the
      drug to determine what effect it has on markers of inflammation, cholesterol levels and
      thickness of blood vessels.
    

Intervention name(s): Rosuvastatin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): encapsulated tablet 20mg daily; Placebo arm included to maintain blinding
Other intervention name(s): Brand name: Crestor; Sugar Pill
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV; Cardiovascular disease; Inflammation; Statin
Irinotecan Plus Gemcitabine in Treating Patients With Unresectable or Metastatic Solid Tumors
Condition: Bladder Cancer; Breast Cancer; Colorectal Cancer; Kidney Cancer; Lung Cancer; Pancreatic Cancer
MeSH terms: Breast Neoplasms; Lung Neoplasms; Pancreatic Neoplasms; Urinary Bladder Neoplasms; Kidney Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells.

      PURPOSE: Phase I trial to study the effectiveness of combining irinotecan and gemcitabine in
      treating patients who have unresectable or metastatic solid tumors.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the maximum tolerated dose (MTD) and the principal toxicities of irinotecan
           and gemcitabine in patients with surgically unresectable or metastatic solid tumors.

        -  Determine if the principal toxicities and MTD of this combination regimen are affected
           by drug sequencing in this patient population.

        -  Determine the potential for gemcitabine to alter the pharmacokinetic characteristics
           when administered with irinotecan in these patients.

        -  Describe the influence effected by varying the administration sequence of this
           combination regimen in this patient population.

        -  Obtain preliminary data regarding efficacy of this combination regimen in these
           patients.

      OUTLINE: This is a dose-escalation study.

      Patients receive irinotecan IV over 90 minutes followed by gemcitabine IV over 30 minutes on
      days 1 and 15. Treatment repeats every 4 weeks in the absence of disease progression or
      unacceptable toxicity. Once the maximum tolerated dose (MTD) is reached, patients receive
      subsequent doses of the inverse sequence of the combination drugs until a new MTD is
      determined.

      Cohorts of 3-6 patients receive escalating doses of irinotecan and gemcitabine until the MTD
      is reached. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients
      experience dose limiting toxicities.

      Patients are followed every 3 months until death.

      PROJECTED ACCRUAL: At least 12 patients will be accrued for this study.
    

Intervention name(s): gemcitabine hydrochloride; irinotecan hydrochloride
Intervention type(s): Drug; Drug
Intervention MeSH terms: Gemcitabine; Irinotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV colon cancer; stage IV breast cancer; recurrent breast cancer; recurrent non-small cell lung cancer; recurrent pancreatic cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer; stage IV renal cell cancer; recurrent renal cell cancer; extensive stage small cell lung cancer; recurrent small cell lung cancer; recurrent bladder cancer; stage IV bladder cancer; stage IV non-small cell lung cancer; stage IV pancreatic cancer
Efficacy of the Combination of Ibuprofen and Paracetamol in Acute Non-specific Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the present study is to assess the efficacy and safety of paracetamol/ibuprofen
      Fixed Dose Combination (FDC) compared to ibuprofen in patients with uncomplicated
      non-specific acute low back pain after a 3-day treatment period.
    

Detailed description: 
      This is a Phase IV, multicenter, international, open-label, parallel-group study.

      The study will be conducted at sites located in Italy, Poland and Hungary. The sites will be
      outpatient facilities and hospitals. A total of 176 patients are planned to be included in
      the study This trial will be conducted in accordance with the study protocol, GCPs,
      Declaration of Helsinki (including up-to-date versions) and applicable regulatory
      requirements.

      The present clinical trial aims to evaluate the efficacy and safety of the combination of 2
      tablets of paracetamol 500 mg/ibuprofen 150 mg administered 3 times daily, in the management
      of patients with acute non-specific Low Back Pain (LBP) condition.
    

Intervention name(s): Tachifene; Brufen
Intervention type(s): Drug; Drug
Intervention description(s): paracetamol 500 mg/ibuprofen 150 mg FDC, film-coated tablets. Two tablets 3 times daily for 3 days (i.e., every 8 hours ± 1 hour).; ibuprofen 600 mg, film coated tablets. One tablet 3 times daily for 3 days (i.e., every 8 hours ± 1 hour).
Other intervention name(s): paracetamol 500 mg/ibuprofen 150 mg; ibuprofen 600 mg
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: low back pain; ibuprofen; Paracetamol; Tachifene®
Ice Plant (Mesembryanthemum Crystallinum) Extract in Patients With Impaired Fasting Glucose
Condition: Impaired Fasting Glucose
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      The investigators will conduct a randomized, double-blind, placebo-controlled study to
      investigate the effects and tolerability of ice plant (Mesembryanthemum crystallinum) extract
      in patients with impaired fasting glucose for 12 weeks.
    

Detailed description: 
      A previous animal study has indicated that ice plant (Mesembryanthemum crystallinum) extract
      (IPE) has a substantial effect on attenuating hyperglycemia and modulating gut microbiota
      composition in diabetic rats. Therefore, IPE might be a promising functional food for the
      prevention of diabetes. Therefore, the investigators will conduct a randomized, double-blind,
      placebo-controlled study to investigate the effects of IPE in patients with impaired fasting
      glucose for 12 weeks; the safety of the compound is also evaluated. The Investigators examine
      75-g oral glucose tolerance test (OGTT) (120 minute glucose), 75-g OGTT incremental Area
      Under the Curve 0-120min, 75-g OGTT (0, 30, 60, 90 minute glucose), fasting insulin,
      Homeostasis Model Assessment for Insulin Resistance, Quantitative Insulin Sensitivity Check
      Index, HbA1c, lipid profile (total cholesterol, triglyceride, low-density lipoprotein
      cholesterol, high-density lipoprotein cholesterol) at baseline and after 12 weeks of
      intervention. One hundred adults were administered either 2,000 mg of IPE or a placebo each
      day for 12 weeks.
    

Intervention name(s): Ice plant group; Placebo group
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Ice plant extract 2,000 mg/day for 12 weeks; Placebo 2,000 mg/day for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
The Cortisol Levels During Cardiac Surgery. The Comparison Between Etomidate and Thiopentone
Condition: Coronary Artery Disease; Valvular Heart Disease
MeSH terms: Coronary Artery Disease; Heart Diseases; Heart Valve Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      During induction for cardiac surgery, patient hemodynamic stability is achieved by using
      anesthetic drugs which least affects hemodynamics such as benzodiazepines, etomidate.
      Etomidate although has been used for a long time but its safety regarding cortisol synthesis
      suppression is still doubtful. This study measures the changes in cortisol levels during
      cardiac surgery with the use of cardiopulmonary bypass by comparison between two inductive
      agents (etomidate and thiopentone). Recording data also include hemodynamic changes during
      induction, inotropic use for coming of cardiopulmonary bypass, blood glucose levels, amount
      of insulin usage, length of ICU and hospital saty.
    

Detailed description: 
      Ninety-two cardiac patients who undergoing cardiopulmonary bypass graft (CABG) or valve
      surgery will be enrolled in this study. They will be randomized into two groups (thiopentone
      and etomidate groups). Apart from different in two inductive drugs, other anesthetics will be
      the same. We record hemodynamic changes during inductions, inotropic use (dose and duration),
      blood glucose levels, total insulin requirement to keep blood glucose 140-180 mg% in
      perioperative period, duration of mechanical ventilation, length of stay in ICU and total
      hospital length of stay. The changes in cortisol levels will be recorded at time 0 (before
      induction), 2, 4, 8, 24 hours in 26 patients (13 patients in each group and only patients who
      are the first in the operating list (morning list)).The 26 patients is needed from sample
      size equation for the changes in cortisol level and the 92 patients is calculated from the
      differences in inotropic use.
    

Intervention name(s): etomidate; thiopentone
Intervention type(s): Drug; Drug
Intervention description(s): During induction, after 3 mcg/kg of fentanyl and 0.05 mg/kg of midazolam given, small doses 2-4 mg (1-2 ml) of etomidate will be given by titration (the syringe pump and extension and three way stopcock are covered to blind the study drug) until the patients are unconscious.; During induction, after 3 mcg/kg of fentanyl and 0.05 mg/kg of midazolam given, small doses 25-50 mg (1-2 ml) of thiopentone will be given by titration (the syringe pump and extension and three way stopcock are covered to blind the study drug) until the patients are unconscious
Other intervention name(s): Etomidate Lipuro (B Braun company); Anesthal (Jagsonpal pharmaceuticals Ltd)
Intervention MeSH terms: Thiopental; Etomidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: etomidate; cortisol level; inotrope; cardiac patients
Gut Flora and Lipid Metabolism
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      It is well known that metabolic responses to diet and drugs are affected by genetic and
      environmental factors. Still, a large part of differences in responses between individuals
      remains unexplained. To increase our understanding of individual differences, more and more
      attention is paid to the role of intestinal microbiota. Not only energy and glucose may be
      related to the microbiota, but also lipid metabolism. This is not surprising as lipid
      metabolism, glucose metabolism, and obesity are closely linked.

      There is substantial evidence from in particular animal studies that the gut microbiota is
      related to lipid and lipoprotein metabolism. However, there is less evidence to what extent
      modulation of the gut microbiota changes lipid and lipoprotein metabolism in humans.
    


Intervention name(s): Amoxicillin; Placebo capsule
Intervention type(s): Drug; Drug
Intervention description(s): 2 capsules of 250mg, 3 times per day during 1 week; 2 capsules of 250mg, 3 times per day during 1 week
Intervention MeSH terms: Amoxicillin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: gut flora; antibiotics; lipid metabolism; LDL cholesterol
A Phase 2 Study to Evaluate Pharmacodynamics of YKP10811 in Patients With Chronic or Functional Constipation
Condition: Chronic Constipation; Functional Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      This will be a single-center, randomized, parallel group, multiple dose administration,
      double-blind, placebo-controlled study to evaluate the effects of YKP10811 on gastric, small
      bowel, and colonic transit in patients with Chronic Constipation or Functional Constipation.
      Four groups including a placebo group will be enrolled and will receive multiple oral doses
      of YKP10811 or matching placebo.
    

Detailed description: 
      If the participant fulfills the initial eligibility criteria, the patient will be randomized
      to 1 of the active treatment groups or placebo. During the treatment period, patients will
      receive study medication once daily for 8 days. Patients will undergo scintigraphic
      assessment of gastric, small bowel and colonic transit of solids over the 48-hour period.

      Patients will be males or females, 18 through 65 years of age with a body mass index (BMI) of
      19 through 40 kg/m2, with Chronic Constipation or Functional Constipation and no evidence of
      evacuation disorder as assessed by the Investigator and meet all the inclusion criteria and
      none of the exclusion criteria.
    

Intervention name(s): Placebo Capsule; YKP10811 Drug Product Capsule; YKP10811 Drug Product Capsule; YKP10811 Drug Product Capsule
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): This is the placebo capsule; The drug product, YKP10811, 10 mg under investigation; The drug product, YKP10811, 20 mg under investigation; The drug product, YKP10811, 30 mg under investigation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic constipation (CC); Functional Constipation (FC); Gastric Emptying; Colon Transit; multiple doses of YKP10811; gastrointestinal transit; colonic transit
Cardiovascular Risk Markers in Spinal Cord Injured Subjects of the Wheelchair Dancer Study
Condition: SCI - Spinal Cord Injury; Cardiovascular Risk Factor
MeSH terms: Spinal Cord Injuries
Study type: Observational

Summary: 
      The present study will analyze if exercise is able to elicit the well-known anti-atherogenic
      effects in patients with SCI. This will be evaluated by measuring vascular parameters such as
      endothelial and inflammatory blood markers, echocardiography of the heart and peripheral
      vessels, as well as blood pressure and arterial stiffness, in subjects performing either
      wheelchair dancing, wheelchair marathon or no sports. Further, it will be investigated,
      whether there is an association between neuroplasticity and cardiovascular health, as
      measured by electroencephalography (EEG), transcranial magnetic stimulation (TMS) and blood
      levels of the brain-derived neurotrophic factor (BDNF).

      We hypothesize that the cardiovascular, physical and psychological benefits of wheelchair
      dancing and/or wheelchair marathon parallel improved neuroplasticity in SCI-patients
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        healthy participants, wheelchair users
Regulation of Bone Formation in Renal Osteodystrophy
Condition: Secondary Hyperparathyroidism; Renal Osteodystrophy
MeSH terms: Chronic Kidney Disease-Mineral and Bone Disorder; Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Interventional
Phase: Phase 2

Summary: 
      To examine the effects of two types of active vitamin D (calcitriol and doxercalciferol) and
      two phosphate binders (sevelamer and calcium carbonate) on the bone disease and blood tests
      of children with kidney failure
    

Detailed description: 
      Pediatric patients treated with CCPD who displayed biochemical and bone biopsy proven
      secondary hyperparathyroidism were randomly assigned to one of 2 vitamin D analogues
      (calcitriol or doxercalciferol) and one of two phosphate binders (sevelamer or calcium
      carbonate) in a two by two factorial designed prospective trial. Serum biochemical
      measurements were obtained at baseline and monthly throughout the 8 months of the trial. Bone
      biopsy was obtaine at baseline and repeated at study completion.
    

Intervention name(s): 1 alpha D2; 1,25 dihydroxy vitamin D3; Sevelamer HCl; Calcium Carbonate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Vitamin D sterol; Active vitamin D sterol; Phosphate binder; Phosphate binder
Other intervention name(s): Doxercalciferol; Hectoral; Calcitriol; Rocaltrol; Renagel; Tums; Titrilac
Intervention MeSH terms: Vitamin D; Cholecalciferol; Calcitriol; 1 alpha-hydroxyergocalciferol; Dihydroxycholecalciferols; Calcium Carbonate; Calcium; Sevelamer
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment