bioihbjkbjnl/mcl2 huggingface dataset:
Short-term Presurgical Study to Assess Molecular Predictors of Lapatinib's Effects in Primary Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      To provide an in vivo measure of the activity of lapatinib. To assess the antiproliferative
      effects of lapatinib in breast cancer, ie how much lapatinib slows down the growth of cancer
      cells by measuring K167 (a marker of proliferation) in breast tumours before and after a
      short treatment with lapatinib.
    

Detailed description: 
      Randomised multi centre double blind pre-surgical study in women with a histological
      diagnosis of breast cancer by core biopsy.
    

Intervention name(s): Lapatinib; Lapatinib-Placebo
Intervention type(s): Drug; Drug
Intervention description(s): In order for patients to take their study medication for 14 days only, treatment should commence on the 14th day prior to the day before scheduled surgery (i.e. if surgery is scheduled for the 15th of the month, tablets should be taken from the 1st to the 14th of that month).
Lapatinib tablets are dispensed as 250mg tablets. Patients should be advised to take all 6 tablets at once as one dose (total daily dose 1500mg). Tablets should be taken on an empty stomach either one hour before or one hour after a meal at the same time each day and according to the instructions on the bottle.; In order for patients to take their study medication for 14 days only, treatment should commence on the 14th day prior to the day before scheduled surgery (i.e. if surgery is scheduled for the 15th of the month, tablets should be taken from the 1st to the 14th of that month).
Lapatinib-placebo tablets will be composed of lactose, cellulose, starch, magnesium stearate, and coated with Opadryl orange and look the same as the active treatment. The patients should take all 6 tablets at once as one dose.
Other intervention name(s): Tyverb
Intervention MeSH terms: Lapatinib
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ki67; Molecular; antiproliferative
Homeopathic Remedy for the Third Stage of Delivery
Condition: Third Stage of Labor
Study type: Interventional
Phase: Phase 3

Summary: 
      The homeopathic remedy consisting of Arnica and Bellis perennis have been shown in a previous
      pilot study (n=33) to reduce blood loss during the third stage of delivery, when compared
      with placebo treatment. The purpose of this study is to repeat the previous methodology, this
      time on a larger population.

      210 parturients will be randomized to one of three groups: Arnica montana C6 and Bellis
      perennis C6 (n=70), Arnica montana C30 and Bellis perennis C30 (n=70), or double placebo
      (n=70).
    


Intervention name(s): Homeopathy 1; Homeopathy 2; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Arnica montana C6 and Bellis perennis C6; Arnica montana C30 and Bellis perennis C30; globule identical to true homeopathy comparators
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: third stage, labor, postpartum hemorrhage, homeopathy, arnica, bellis perennis
Acceleration of Lower Anterior Teeth Leveling and Alignment Using Corticision
Condition: Crowding, Tooth
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      This experimental study will evaluate the effect of corticision on accelerating the leveling
      and alignment of lower crowded incisors compared with the control untreated group using cone
      beam computed tomography.

      The study sample will consist of 26 patients with less than 6 mm crowding. The sample will be
      allocated randomly into two experimental groups.

      The brackets and passive SS wire will be applied with radiographic metal guides between each
      tooth to allow for accurate corticision site 2 mm below the gingival papilla and to prevent
      tooth roots injury. The dentoalveolar changes occurring after leveling and alignment of lower
      anterior teeth will be evaluated using CBCT radiographs, Frequency, degree of root
      resorption, and the incidence of bone dehiscence will be assessed in relation to initial
      situation.
    

Detailed description: 
      Crowding is the most common form of malocclusion. Different methods have been used to resolve
      crowding, including extraction and nonextraction. Corticision is an important methods to
      accelerate tooth movement in crowded cases. Cortical bone incision without flap elevation
      enhances turnover rate of surrounding structures and decreases the time for leveling and
      alignment. In orthodontics, CBCT imaging has been applied to evaluate impacted teeth and root
      resorption. But the data are very rare regarding the application of CBCT in tooth movement.
      So CBCT will be used in this research to evaluate the amount of external apical root
      resorption (EARR) and presence of dehiscence in the lower anterior teeth in the crowded
      cases. Furthermore, the duration of alignment will be compared between corticision group and
      non-corticision group.
    

Intervention name(s): Traditional fixed appliance; Corticision
Intervention type(s): Device; Procedure
Intervention description(s): aligning and leveling of lower anterior teeth using traditional fixed appliance.; Corticison, cortical bone incision without flap elevation, will be applied to the lower anterior teeth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: corticision; CBCT; Crowding
Effect of Epidural Steroid Injection on Bone Mineral Density in Postmenopausal Women
Condition: To Assess the Changes in Markers of Bone Turnover Over a Six Month Period After Epidural Steroid Inject; To Assess the Changes in Bone Mineral Density.
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate for the effect of corticosteroid epidural injections on bone mineral density in
      postmenopausal women. Candidates for the study: Post menopausal women between the ages of 55
      and 80. No history of bone disease. No thyroid/parathyroid disorder. not used injected or
      oral steroids in the last year. No recent smoking.

      The purpose is to identify any significant change in bone mineral density with the use of
      epidural steroid injections. This may implicate the need for patient counseling regarding
      this possible side effect and the possible use of preventive measures to avoid this adverse
      effect.
    

Detailed description: 
      Glucocorticoids reduce bone formation and increase bone loss via a variety of mechanisms.
      This effect has been shown to be dose-dependent. Doses as low as 10mg of Prednisone, has been
      shown to lower bone density over periods as short as 20 weeks, an effect which may be
      prevented with use of Calcium and Vitamin D. Inhaled Tramcinilone has also been shown to lead
      to dose-related loss of bone at the hip in premenopausal women. Clinic visits will be
      arranged for recruited patients at baseline and then at 3 and 6 months after the ESI and at
      any time for new-onset or severe back pain. During the initial visit, consent will be
      obtained, patient will be given details on the study design and rationale, severity and
      characteristics of back pain. Epidural corticosteroid injection (ESI) has been shown to
      decrease pain, speed return of function, and improve neurological signs in patients
      presenting with low back pain.
    

Intervention name(s): Triamcinilone (kenalog)
Intervention type(s): Drug
Intervention description(s): Epidural steroid injection of 80mg of Triamcinilone.
Intervention MeSH terms: Triamcinolone Acetonide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Epidural Injection; Bone Density
Effect of Acute Dietary Supplementation With Grape Seed Extract on Aortic Stiffness, Arterial Pressure, and Blood Vessel Dilation in Collegiate Obese Individuals at Rest
Condition: Obesity
Study type: Interventional

Summary: 
      This study investigated if elevated BP and aortic stiffness characterized in obese
      individuals are attenuated following acute grape seed extract supplementation. It is
      hypothesized that acute dietary supplementation with grape seed extract attenuates aortic
      stiffness, systolic blood pressure, diastolic blood pressure, mean arterial pressure, and
      total peripheral resistance and these effects are partially due to reductions in peripheral
      vasoconstriction
    

Detailed description: 
      Twenty men (obese = 10; normal body weight (NBW) = 10) participated in this study. Effects of
      placebo (PL: 600 mg) and GSE (600 mg) on systolic blood pressure (SBP), diastolic blood
      pressure (DBP), mean arterial pressure (MAP), heart rate (HR), stroke volume (SV), cardiac
      output (Q), total peripheral resistance (TPR), and AoS were compared 2 h after ingestion of
      GSE or PL on different days, one week apart. Arterial blood pressure was measured using a
      sphygmomanometer from a brachial artery at the level of the heart on chair. HR and SV were
      continuously measured using a non-invasive device (Physio Flow). CO was calculated by HR X
      SV. TPR was calculated by MAP/CO.
    

Intervention name(s): Grape seed extract
Intervention type(s): Dietary Supplement
Intervention description(s): Two capsule grape seed extract (total 600 mg)
Intervention MeSH terms: Grape Seed Extract
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Esophageal Hypersensitivity Study in Patients With Gastroesophageal Reflux Disease (GERD)
Condition: Sensitivity in Esophagus
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to compare sensitivity of visceral pain in the esophagus using
      different pain stimuli.
    


Intervention name(s): AZD1386; Placebo to AZD1386
Intervention type(s): Drug; Drug
Intervention description(s): 95 mg, oral solution, single dose; Placebo, oral solution, single dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: GERD; patient; esophagus; pain
Safety, Efficacy, and Feasibility of High-dose Cholecalciferol in Pediatric Patients With Cystic Fibrosis
Condition: Vitamin D Deficiency
MeSH terms: Cystic Fibrosis; Vitamin D Deficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      Children with Cystic Fibrosis, ages greater than and equal to 36 months of age and less than
      or equal to 18 years of age, with a 25OHD level less than 30 ng/dL will be asked to
      participate in this study. Upon consent, they will be given oral cholecalciferol
      supplementation of 250,000 IU during their next CF clinic visit. The safety will be assessed
      by measuring a serum calcium level within 1 week of supplementation. Efficacy will be
      assessed using repeated 25OHD levels throughout the course of 12 months. Feasibility will be
      assessed with the previous two measures as well as a brief questionnaire administered via
      telephone within 1 week of supplementation.
    

Detailed description: 
      Children and adults with Cystic Fibrosis (CF) are at risk of developing a vitamin D
      deficiency or insufficiency, defined as a 2,25-hydroxyvitamin D (25OHD) serum blood level <30
      ng/dL. Greater than 85% of people with CF have pancreatic insufficiency, which contributes to
      poor absorption of fat soluble vitamins in addition to dietary fat. A 25OHD level greater
      than 30 ng/dL has been described as providing potential improvements to markers of
      inflammation in adults with CF and is known to improve bone mineral density and prevent bone
      fractures in all populations, including CF. This study will assess the safety of a one-time
      high dose of cholecalciferol or vitamin D3 along with the efficacy and feasibility.

      Children between the ages of 3 years and 18 years (inclusive), with a 25OHD level <30 ng/dL
      will be provided with a vitamin D3 supplement of 250,000 international units (IU) observed in
      our CF clinic. We hypothesize that this one-time, oral, high dose of vitamin D3 will safely
      and effectively raise the 25OHD level to above 30 ng/dL.

      Safety will be monitored with serum calcium levels 1 week following the dosage, since 25OHD
      has a half-life of 2-3 weeks and this serum calcium level measurement time-point would be in
      or near the middle of this range. Feasibility will be measured using a 5-question phone
      survey 1 week following the dosage (see appendix A - attached). Efficacy will be measured by
      the 25OHD level itself; if 25OHD levels are found to be between 30-100 ng/dL over the course
      of the study, the dose will have demonstrated effective in achieving the study's goal.

      The purpose of this study is to show that 25OHD levels can be safely corrected with a
      one-time dose of vitamin D3 that can be safely and feasibly provided in the outpatient
      setting to children with CF.
    

Intervention name(s): Treatment
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Family Centered Intervention After Traumatic Brain Injury
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effectiveness of a multi-professional
      theoretically based family centered intervention, The Traumatic Brain Injury Family System
      Intervention (TBIFSI), for the family members and TBI patients in improving family dynamics
      and functioning. The intervention will be provided in collaboration with the municipal
      rehabilitation service. The intervention group will be compared with a control group
      receiving treatment as usual, defined as an individually tailored multidisciplinary approach,
      and the family members will attend one ongoing psycho-educational group session of 2.5 hour
      provided by Oslo University Hospital (OUH).
    


Intervention name(s): The Traumatic Brain Injury Family System Intervention.; Psycho-educational session at OUH
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Theoretically based intervention consisting of 8 weekly 90 minutes sessions addressing specific topics according to a manual.; 2.5 hour psycho-educational session for the patient's family members.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study to Assess the Pharmacokinetics and Safety of Single Doses of Anifrolumab in Healthy Subjects
Condition: Safety; Pharmacokinetics; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, Randomized, Placebo-Controlled, Double-Blind Study to Assess the
      Pharmacokinetics and Safety of anifrolumab following Single-Dose administration to healthy
      subjects
    

Detailed description: 
      This is a Phase I placebo-controlled study to assess the pharmacokinetics, safety and
      tolerability of 2 doses of anifrolumab via the subcutaneous (SC) route of administration and
      1 dose of anifrolumab via intravenous (IV) route in healthy subjects
    

Intervention name(s): Anifrolumab SC injection (300mg); Anifrolumab IV infusion (300mg); Anifrolumab SC infusion (600mg); Anifrolumab placebo SC injection (300mg); Anifrolumab placebo IV infusion (300mg); Anifrolumab placebo SC infusion (600mg)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 300 mg of anifrolumab delivered as 2 separate 1 mL SC injections administered serially on Day 1; 300 mg of anifrolumab delivered as an IV infusion over 30 minutes on Day 1; 600 mg of anifrolumab delivered as 4 mL SC by infusion pump on Day 1; 300mg of placebo delivered as 2 separate 1 mL SC injections administered serially on Day 1; 600mg of placebo delivered as an IV infusion over 30 minutes on Day 1; 600 mg of placebo delivered as 4 mL SC by infusion pump on Day 1
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Tolerability; Anifrolumab; Subcutaneous injection; Intravenous infusion
Eletric Stimulation for Hipossalivation Induced by Radiotherapy
Condition: Hyposalivation; Electric Stimulation Therapy; Head and Neck Neoplasm; Radiotherapy
MeSH terms: Head and Neck Neoplasms; Xerostomia
Study type: Interventional

Summary: 
      Currently, cancer is a disease of high incidence, already considered a public health problem.
      Among the most prevalent are head and neck neoplasms, and depending on the location and
      extent of the lesion, the treatments are surgery, chemotherapy and / or radiotherapy that
      have a great impact on the quality of life. Radiation therapy is a frequently chosen
      treatment, and depending on the dose of radiation, causes changes such as hyposalivation.
      There are techniques for salivary flow stimulation, however, most of the options involve the
      use of medications, which limits administration to part of the patients. Transcutaneous
      electric nerve stimulation (TENS) is an alternative that has been used to stimulate salivary
      flow, however there is a limited number of studies that have tested this technique after
      radiotherapy. The aim of this study was to verify the effect of TENS in increasing the
      salivary flow of individuals receiving radiotherapy to treat tumors of the head and neck. The
      sample will have 80 patients randomly divided into two groups: TENS group and Control group.
      In both groups, a quality of life questionnaire (UW-QOL) will be applied and a
      speech-language assessment will be performed. The hypothesis of this research is that TENS is
      effective in increasing the amount of saliva. Secondary outcomes involve the evaluation of
      the effect of this technique on the quality of life, mainly in the questions: speech,
      chewing, saliva and deglutition.
    

Detailed description: 
      The sample will have 80 patients randomly divided into two groups: 1) TENS group; 2) control
      group. A quality of life questionnaire (UW-QOL) will be applied and a speech-language
      assessment will be performed. The hypothesis of this research is that TENS increasing the
      amount of saliva. Secondary outcomes involve the evaluation of the effect of this technique
      on the quality of life, mainly in the questions: speech, chewing, saliva and deglutition.
    

Intervention name(s): TENS
Intervention type(s): Device
Intervention description(s): TENS Group: Pre-test evaluations (Clinic Conditions; Live Quality; Salivary Flux); TENS treatments (50Hz / pulse duration of 250 ms / high intensities tolerated / continuously for 20 minutes / 2 sessions a week / 4 weeks / total of the 8 TENS sessions) and Post-test evaluations.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Effect of Gum Acacia (FibregumTM) on Post-prandial Glucose, Insulin Levels and Food Intake
Condition: Healthy; Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Study to evaluate the effect of gum acacia (FibregumTM) on post-prandial glucose and insulin
      levels and food intake in normal-weight and overweight subjects during a 2-7 weeks
      intervention period. In addition, tolerability and safety of gum acacia (FibregumTM) will be
      assessed.
    

Detailed description: 
      Gum arabic is a heteropolysaccharide (molecular weight 350-850 kDa) harvested from Acacia
      seyal or Acacia senegal. It is highly soluble and broadly used in numerous solid and liquid
      food matrices.

      For the assessment of non-digestible carbohydrates as dietary fiber, it is eminent to
      demonstrate that its consumption is related to a specific beneficial physiological effect
      shown in an appropriate clinical study. The aim of the present trial was to expand the
      clinical evidence with respect to beneficial effects of gum acacia on post-prandial blood
      glucose levels, post-prandial insulin levels and prospective ad libitum food intake, in
      normal-weight and overweight subjects.

      The present double-blind, randomized, controlled, three-way cross-over study was to evaluate
      the effect of gum acacia versus no treatment on post-prandial glucose (PPG) levels in
      normal-weight and overweight subjects during a 2-7 weeks intervention period.

      Additionally, post-prandial insulin (PPI) levels, prospective ad libitum food intake, as well
      as the safety and tolerability of gum acacia were assessed.
    

Intervention name(s): 40 g Gum acacia (FibregumTM); 20 g Gum acacia (FibregumTM); 0 g Gum acacia (FibregumTM)
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Applied in 300 mL of orange juice with breakfast (single use at visit); Applied in 300 mL of orange juice with breakfast (single use at visit); 300 mL of orange juice with breakfast (single use at visit)
Other intervention name(s): D1; D2; no treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double-blind, randomized, controlled, three-way cross-over design, monocentric nutritional study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: gum acacia; post-prandial glucose (PPG); post-prandial insulin (PPI); blood glucose incremental; appetite sensation; E 414; food additive; FibregumTM; appetite; dietary fibre
A Study of Albuferon With Ribavirin in Interferon Treatment Experienced Subjects With Chronic Hepatitis C
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, multi-center, randomized, open-label study to evaluate the safety,
      tolerability, and efficacy of Albuferon in subjects with hepatitis C (HEP C) who failed to
      respond to previous interferon alfa therapy.
    


Intervention name(s): Albuferon; Ribavirin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment