bioihbjkbjnl/mcl2 huggingface dataset:
Avoiding Growth Factor During Paclitaxel Treatment in Breast Cancer
Condition: Early Stage Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This research study is testing the safety and feasibility of delivering the 4 cycles of
      'dose-dense' paclitaxel without the use of Neulasta (Pegfilgrastim) as a Granulocyte
      Colony-stimulating Factor (G-CSF) support. The research study is for participants who have
      early stage breast cancer and have been recommended to receive a standard chemotherapy
      regimen, doxorubicin/cyclophosphamide (AC) plus Paclitaxel (T), in what is called a
      "dose-dense" fashion to prevent recurrences.
    

Detailed description: 
      Low white cell blood counts increase the risk of infections; thus, in order to give each
      cycle of chemotherapy, white blood cell count must have recovered adequately in between
      cycles. Traditionally, this regimen has been given with the use of a medicine called Neulasta
      (Pegfilgrastim) to speed the recovery of the white blood cell count in order to maximize the
      chances that the next cycle of chemotherapy can be given on time.

      The names of the study interventions involved in this study are:

      -- Neulasta (Pegfilgrastim)
    

Intervention name(s): Paclitaxel; Neulasta
Intervention type(s): Drug; Drug
Other intervention name(s): Taxol; Onxal; Pegfilgrastim
Intervention MeSH terms: Paclitaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Early Stage Breast Cancer
Safety, Tolerability and Pharmacokinetic Profile of Ascending Oral Doses of MMV390048, Part A
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase I study will evaluate the safety, tolerability and pharmacokinetic properties of
      escalating single doses of reformulated MMV390048 when administered to healthy men and women
      of non-childbearing potential (WNCBP) under fasted conditions (Part A).
    

Detailed description: 
      This Phase I study will evaluate the safety, tolerability and pharmacokinetic properties of
      escalating single doses of reformulated MMV390048 when administered to healthy men and women
      of non-childbearing potential (WNCBP) under fasted conditions (Part A).

      Primary objectives:

      • To evaluate the safety and tolerability of single ascending doses of MMV390048 administered
      orally to healthy subjects (men and WNCBP) under fasted conditions

      Secondary objectives:

      • To describe the pharmacokinetics of MMV390048 in healthy subjects (men and WNCBP) after
      single oral dose administration
    

Intervention name(s): MMV390048 40 mg; Placebo to match MMV390048 40 mg; MMV390048 80 mg; Placebo to match MMV390048 80 mg; MMV390048 120 mg; Placebo to match MMV390048 120 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: malaria, single ascending dose,
The Effect of Growth Hormone Releasing Hormone on Cognitive Function in Individuals With Mild Cognitive Impairment
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is examining the effects of growth hormone releasing hormone (GHRH) on mild
      cognitive impairment (MCI). GHRH will be given at a dose of 1mg/day for 10 weeks to subjects
      with MCI as well as healthy controls.
    

Detailed description: 
      Subjects with MCI as well as healthy controls will be given GHRH at a dose of 1mg/day for 10
      weeks.

      This study is designed to investigate the effects of GHRH on the following things: 1)
      cognitive function as measured by our neuropsychologist with a series of short tests; 2)
      brain activity as measured by fMRI 3) lean and fat mass of your body as measured by DEXA; 4)
      physical function as measured by a walking test.
    

Intervention name(s): Growth Hormone Releasing Hormone (GHRH); Placebo Growth Hormone Releasing Hormone
Intervention type(s): Drug; Drug
Intervention description(s): Growth Hormone Releasing Hormone (GHRH) 1mg/day for 10 weeks; Placebo GHRH to be given once daily for 10 weeks
Other intervention name(s): Egrifta; tesamorelin; Placebo
Intervention MeSH terms: Hormones; Growth Hormone-Releasing Hormone; Tesamorelin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effect of Back School-based Intervention on Non-specific Low Back Pain in Adults.
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The study consists of a theoretical and practical intervention based on the Back School. This
      intervention will be carried out over 8 weeks with a frequency of two sessions per week, for
      a total of 16 sessions of 45 minutes duration. Of all the sessions, 14 had a practical focus
      (strength and stretching exercises) and the other two had a theoretical focus
      (self-management techniques and pain neuroscience education). In addition, they had an
      initial session and a session at the end of the of the intervention in which measurements of
      the different variables were taken (The Visual Analogue Scale; Roland morris disability
      questionnaire scoring; Short Form 36 Health Survey; Tampa Scale Of kinesiophobia).These
      variables will be measured on two occasions, at the beginning of the study and at the end of
      the intervention, an average of 2 months.

      The clinical practice guidelines highlight the importance of neck pain prevention through
      exercise an education. There are previous studies of the effects of theoretical and practical
      programmes based on back school on the lumbar region but not on the cervical region.
      Therefore, the aim of this study is to investigate the effects of a BS-based intervention on
      low back pain and functionality as well as kinesiophobia and quality of life in adults. The
      hypothesis previously hypothesised that this BS-based intervention would have positive
      effects on pain, functionality, kinesiophobia and quality of life.
    


Intervention name(s): Back school
Intervention type(s): Behavioral
Intervention description(s): Intervention was carried out for 8 weeks with a frequency of two sessions per week, with a total of 16 sessions lasting 45 min. Of all the sessions, 14 had a practical focus and the other two had a theoretical focus. In the practical part, strengthening and stretching exercises were performed. In the theoretical part, self-management and pain neuroscience education were performed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
AZP-3601 SAD and MAD Study in Healthy Subjects and Patients With Hypoparathyroidism
Condition: Chronic Hypoparathyroidism
MeSH terms: Hypoparathyroidism
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is investigating the safety, tolerability, pharmacodynamics and pharmacokinetics
      of AZP-3601 following single and repeated administration in both healthy volunteers and
      patients with chronic hypoparathyroidism (cHP)

      The protocol includes 3 parts:

        -  Part A: first-in-human single ascending dose (SAD) study in healthy volunteers

        -  Part B: multiple ascending dose (MAD) study with 2 weeks of treatment in healthy
           volunteers

        -  Part C: open-label MAD study with a total treatment duration of 3 months in patients
           with cHP.
    


Intervention name(s): AZP-3601; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Lyophilized powder of AZP-3601 to be reconstituted with water for injection before injection; Saline solution visually matching active medication
Other intervention name(s): eneboparatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Exercise & Diet Effects on CV Risk in Firefighters
Condition: Cardiovascular Risk Factor; Blood Pressure; Exercise; Diet Modification; Health Promotion
Study type: Interventional

Summary: 
      The study will explore the capacity for a lifestyle modification in firefighters to improve
      blood pressure, blood vessel stiffness, inflammation, and reduce oxidative stress. The study
      will be a pre- post-testing controlled trial with three groups. The intervention will be a
      weekly circuit workout program and a Mediterranean (high fruit/vegetable) diet. The groups
      will be firefighters with >10yrs experience, firefighters with <10yrs experience, and control
      Non-firefighters.
    

Detailed description: 
      Recent statistics from the American Heart Association (AHA) have reported that >92% of adults
      in the U.S. meet at least 1 metric for cardiovascular disease risk factors. In firefighters,
      this increased risk is especially concerning. The National Fire Protection Agency (NFPA)
      estimates there are around 1.3 million firefighters in the United States, 70% of which are
      volunteer. The prevalence of impaired cardiovascular health is higher in firefighters than in
      the general population and the leading line-of-duty death (LODD) cause is cardiac related. It
      is known that exercise and diet mitigate cardiovascular disease risk. Meeting the physical
      activity guidelines remains a target of ideal cardiovascular health and a major public health
      concern. However, the NFPA does not require volunteer fire companies to have a fitness
      program for their crew, and sadly less than a third of the stations actually do. And
      importantly, cardiovascular-related LODD remains a major issue in the firefighter population.
      The results could guide clinical treatment for firefighters and may therefore reduce
      cardiac-related LODD.
    

Intervention name(s): Circuit Training exercise & Modified Mediterranean diet
Intervention type(s): Behavioral
Intervention description(s): Participants will receive circuit training program and a modified Mediterranean diet program. Educational sessions, serving size training, and portion containers will be provided. Participants will also receive individualized support throughout the 6 week intervention.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cardiovascular Disease; Mediterranean Diet; Exercise Training; Blood Pressure
Tocotrienols for School-going Children With ADHD
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine if tocotrienol supplementation given to school
      going children with ADHD will result in reduction of their ADHD symptoms.
    

Detailed description: 
      The main objective of the study is to:

      a. Determine if supplementation of tocotrienol compared to placebo has an effect on the
      symptoms of school going children with ADHD.

      The secondary objective is to:

        1. Determine if supplementation of tocotrienol compared to placebo has an effect on the
           dose of current medication used in school going children with ADHD.

        2. Determine the safety of tocotrienol in the study population.

        3. Determine if tocotrienol levels in children with ADHD correlate with their symptom
           scores.
    

Intervention name(s): Oral mixed tocotrienols; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 200mg per day; Capsules containing soya bean oil that has similar appearance with the mixed tocotrienol capsules
Other intervention name(s): Tocovid Suprabio.
Intervention MeSH terms: Tocotrienols; Vitamin E; Tocopherols; Tocovid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; Children; Tocotrienol
Study To Investigate The Safety And Metabolism Of GSK376501 In Overweight Subjects
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2; Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      This study represents the second Phase 1 study with GSK376501 and the goal is to further
      evaluate its safety and tolerability. The way the human body processes GSK376501 will also be
      determined.
    


Intervention name(s): GSK376501; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): GSK376501
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Diagnostic
Keywords: GSK376501,; Single Dose,; Dose Escalation,; Healthy Overweight/Obese Volunteer
Phase 0/1 Local Application of the Monoclonal Antibody (Mab) sB24M in Patients With Purulent Pyoderma
Condition: Pyoderma; Pyoderma Gangrenosum; Pyoderma Vegetans; Pyoderma Gangrenosum Surrounding Surgical Stoma
MeSH terms: Pyoderma; Pyoderma Gangrenosum
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Phase 0/1 local application of the monoclonal antibody (Mab) sB24M in patients with purulent
      pyoderma (chronic ulcerative pyoderma) by injection into the affected areas.

      Monoclonal antibody (Mab) sB24 negatively regulates immune-inflammatory processes through
      CD47 / TNF-α Axis promotes epithelialization of damaged tissue.
    

Detailed description: 
      This is an open-label Phase 0 trial that will enroll up to 10 participants with purulent
      pyoderma (chronic ulcerative pyoderma) by injecting 200 mg of the monoclonal antibody (Mab)
      sB24M into the areas affected by pyoderma.

      Monoclonal antibody (Mab) sB24 negatively regulates immune-inflammatory processes through
      CD47 / TNF-α Axis promotes epithelialization of damaged tissue.

      This study is a first-in-man since previously no Clinical Studies on the local application
      (injections) of monoclonal antibodies in pyoderma gangrenosum have been conducted.
    

Intervention name(s): Monoclonal antibody (Mab) sB24M
Intervention type(s): Biological
Intervention description(s): 200 mg monoclonal antibody (Mab) sB24 by injection into the affected areas.
Other intervention name(s): CD47 / TNF-α Monoclonal antibody
Intervention MeSH terms: Antineoplastic Agents, Immunological; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Plexus Brachialis Block. Better to do by Start Than by End of Surgery?
Condition: Pain
Study type: Interventional

Summary: 
      The aim of the study is to find out if the timing of brachial plexus block, before or after
      surgery, has an impact of the extent of acute postoperative surgical pain or the incidence
      and severity of long-lasting (chronic) pain after surgery.

      This is a prospective, randomized, double blind study in patients with radial fractures
      undergoing surgery with volar plate. The patients will be followed up for 6 months after
      surgery.
    


Intervention name(s): Plexus brachialis block
Intervention type(s): Procedure
Other intervention name(s): LSIB. Ropivacain 7,5 mg/ml, 0,5 ml/kg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Pain
Assessment of Pulmonary Functions and Peripheral Muscle Strength of COPD Patients in Different GOLD Stages
Condition: Copd
Study type: Interventional

Summary: 
      The purpose of this research was to examine the respiratory functions, respiratory muscle
      strength and peripheral muscle strength of patients with COPD in different groups and to
      evaluate their correlation with the duration and prognosis of the disease in COPD.
    

Detailed description: 
      Chronic obstructive pulmonary disease (COPD) is a common disease characterized by airway
      obstruction against harmful particles and gases in the airway and lungs, and is progressive,
      treatable and preventable.

      The severity of the disease in COPD is determined according to the GOLD (Global Initiative
      for Chronic Obstructive Lung Disease) guidelines (2). While determining the severity of
      airway obstruction with the patient's spirometric values in COPD; Combined COPD assessment is
      made with symptomatic evaluation, number of exacerbations and hospitalizations. Airway
      restriction is numerically (GOLD 1-4), symptom evaluation and exacerbation risk combined with
      letter grouping (Group A-D).

      There is a loss of respiratory and peripheral muscle strength in COPD patients. A mixture of
      various local and systemic causes was responsible for respiratory muscle dysfunction in COPD.
      Immobility, systemic inflammation, hypoxia of the tissue, oxidative stress and increased
      apoptosis of the skeletal muscle have been identified as possible pathogenic factors for loss
      of peripheral muscle strength in COPD patients.

      it was aimed to evaluate the respiratory functions, respiratory muscle strength and
      peripheral muscle strength of patients with different COPD groups clinically and to evaluate
      their correlation with the duration and prognosis of the disease.
    

Intervention name(s): Assessment of COPD patients
Intervention type(s): Other
Intervention description(s): Assessments explained in the arm section were made as described in one session.
Intervention model: Single Group Assignment
Intervention model description: COPD patients: Respiratory muscle strength, peripheral muscle strength in both upper and lower extremity were evaluated. Pulmonary function tests obtained during routine controls of patients.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: COPD; Pulmonary functions; Respiratory muscle strength; Peripheral muscle strength
Bioequivalence Study of Feniramidol HCl 400 mg Film Tablet (Pharmactive, Turkey) Under Fed Conditions
Condition: Bioequivalence
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      OPEN-LABEL, RANDOMISED, SINGLE ORAL DOSE, FOUR-PERIOD, REPLICATED, CROSS-OVER TRIAL TO ASSESS
      THE BIOEQUIVALENCE OF FENIRAMIDOL HCl 400 MG FILM TABLET (TEST DRUG) IN COMPARISON WITH
      CABRAL 400 MG FILM TABLET (REFERENCE DRUG) IN HEALTHY MALE SUBJECTS UNDER FED CONDITIONS
    

Detailed description: 
      Phenyramidol shows its muscle relaxant activity by interneuronal blockage without disrupting
      neuromuscular function. Thus, it relieves muscle spasm, and breaks pain-spasm chain by
      blocking polisynaptic reflexes in the brain and medulla spinalis. It does not affect
      monosynaptic reflexes.

      Phenyramidol has a very high analgesic effect than aspirin and close to codeine. It used in
      the treatment of acute and chronic human musculoskeletal system pains as muscle relaxant and
      analgesic.

      Pharmacokinetics Phenyramidol reaches maximum plasma concentration in an hour (0.25-1) after
      absorption from gastrointestinal tract. It is widely distributed in skeletal muscles and
      involved in circulatory system very slowly.

      Studies have shown that cytochrome P450 enzymes are effective in phenyramidol metabolism. It
      is conjugated with glucuronic acid in the liver and it is excreted as glucuronide conjugates
      from the urinary tract. The drug is eliminated from the bile and the bacterial glucuronidase
      enzymes make the glucuronide conjugate of phenyramidol free. The drug enters enterohepatic
      circulation and is excreted by faeces. Its elimination half-life is 1-2 hours.

      Indications Phenyramidol is indicated in the symptomatic treatment of acute painful muscle
      spasms associated with musculoskeletal system.
    

Intervention name(s): Phenyramydol HCl 400 mg Film Tablet; Cabral 400 mg Film Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Phenyramydol HCL 400 mg Film Tablet contains 400 mg phenyramydol manufactured by Pharmactive Ilac.San ve Tic A.S; Cabral 400 mg Film Tablet 400 mg phenyramydol manufactured by Recordati Ilac SAn ve Tic A.S.
Other intervention name(s): Test Phenyramydol; Reference Phenyramydol
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Full replicate cross-over bioequivalence study
Masking: None (Open Label)
Primary purpose: Other
Keywords: Phenyramidol; Pharmactive Ilaç San.ve Tic. A.S
24-hour IOP-lowering Effect of Brimonidine 0.1%
Condition: Open-angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma, Open-Angle; Ocular Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the efficacy and safety of brimonidine 0.1% three-times daily in
      patients with glaucoma or ocular hypertension
    


Intervention name(s): brimonidine 0.1% (Alphagan® P)
Intervention type(s): Drug
Intervention description(s): Brimonidine 0.1%, 1 drop three-times daily for 4 weeks
Other intervention name(s): Alphagan® P
Intervention MeSH terms: Brimonidine Tartrate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of the Treatment for Infant Iron Deficiency Anemia by Taking Lactoferrin and Ferralia
Condition: Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Study type: Interventional

Summary: 
      A multi-center,randomized,double-blind,controlled clinical trial was used to investigate the
      effectiveness of the treatment of infant iron deficiency anemia by taking ferralia and
      different contents lactoferrin.
    

Detailed description: 
      5-9 months old infants with iron deficiency anemia were randomly divided into three groups.
      On the basis of giving the same dose of ferralia,three different levels lactoferrin infant
      formula were intervened 3 months respectively,and evaluate the clinical effect.
    

Intervention name(s): Standard infant fomula; Low level LF infant formula; High level LF infant formula
Intervention type(s): Other; Other; Other
Intervention description(s): Infants with iron deficiency anemia randomly divided into this group were given the same dose of ferralia with other groups,and were fed with infant formula without lactoferrin supplementation.; Infants with iron deficiency anemia randomly divided into this group were given the same dose of ferralia with other groups,and were fed with infant formula supplemented with low level of lactoferrin (38mg/100g).; Infants with iron deficiency anemia randomly divided into this group were given the same dose of ferralia with other groups,and were fed with infant formula middle supplemented with high level of lactoferrin (76mg/100g).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science