bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Oral Supplementation With a Fibre Enriched Paediatric Sip Feed For Children With Acute Lymphocytic Leukemia
Condition: Acute Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Precursor Cell Lymphoblastic Leukemia-Lymphoma
Study type: Interventional

Summary: 
      This is a randomised, controlled, open-label intervention study. It is hypothesized that
      supplementation with a fibre enriched sip feed will improve the nutritional status, gut
      microbiota and quality of life (QOL) of children with acute lymphoblastic leukemia, and may
      enhance their immune response. This could give them a better chance to finish their induction
      chemotherapy successfully with fewer side effects.
    

Detailed description: 
      Study objectives:

      Primary objective:

      To evaluate the effect of oral supplementation with a fibre supplemented paediatric sip feed
      on the nutritional status of Egyptian children with acute lymphocytic leukemia (ALL) compared
      to standard dietary counseling.

      Secondary objective:

      To evaluate the effect of oral supplementation with a fibre supplemented paediatric sip feed
      on the gut microbiota and quality of life (QoL) of Egyptian children with ALL compared to
      standard dietary counseling.
    

Intervention name(s): NutriniDrink/Fortini MF unflavoured (1.5kcal/ml)
Intervention type(s): Dietary Supplement
Intervention description(s): During the 6-week Intervention period children allocated to group 1 will consume 2 bottles of study product per day (400ml in total).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Improve the nutritional status; QOL; children; enhance immune response; induction chemotherapy; fewer side effects
Immunomodulatory Effects of IVIg on Pregnancy Rate of Patient With Recurrent Pregnancy Loss
Condition: Recurrent Pregnancy Loss
MeSH terms: Abortion, Spontaneous; Fetal Death; Abortion, Habitual; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      Miscarriage occurs in about 1-2% of human pregnancies and is one of the common pregnancy
      problems before 12 weeks of pregnancy. Anatomical and chromosomal abnormalities, microbial
      factors and auto and alloimmune reactions have been speculated to attribute in recurrent
      miscarriage. Unexplained recurrent miscarriage (URM) is defined as three or more repeated
      abortions, probably caused by maternal immunological rejection . Given that maternal immune
      system encounters semi-allogeneic fetus, pregnancy outcome is associated with the interaction
      between maternal immune system and immuno-regulatory capability of the fetus. Effectiveness
      of treatment approaches in RM patients has been controversial and remained to be discovered.
      Immunomodulatory agents such as corticosteroids and allogeneic lymphocyte immunization showed
      variable success rates in RM patients. Therapeutic effects of IVIG in unexplained RM is
      controversial and most positive results were obtained from the trials in RM women with
      cellular immune abnormalities, such as increased NK cell level and/or cytotoxicity, and T
      cell abnormalities. Previous studies have shown that the incidence of genetic abnormalities
      in children who have received immunosuppressive drugs such as IVIg like normal people and
      normal society. In this study we used IVIg at the time of positive pregnancy,400 mg/kg IVIG
      was administered intravenously. Following the first administration, IVIG well given every 4
      weeks through 32 weeks of gestation to suppress the immune system in patients with
      immunological causes of RPL and the results will be compared with a control group that did
      not receive any type of drug.
    


Intervention name(s): IVIg
Intervention type(s): Drug
Intervention description(s): Patients will take 400mg/kg IVIg at the time of positive pregnancy,Following the first administration, IVIG well given every 4 weeks through 32 weeks of gestation.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Recurrent Pregnancy Loss; IVIg; Pregnancy Rate
Efficacy and Safety Study of EVERA to Augment Small Breast
Condition: Atrophy of Breast
MeSH terms: Atrophy
Study type: Interventional

Summary: 
      Expected Total Number of Subjects

        -  Level of significance, alfa 0.05

        -  Power 0.80

        -  Mean difference between two treatments is assumed 35

        -  Standard Deviation is assumed 35.

        -  Follow-up loss is assumed 20%

        -  N=34(each group:17)
    

Detailed description: 
      Study design

        -  single center, randomized, unblind clinical study Medical device

        -  Investigational Medical Device: EVERA

        -  Comparator: ESTES Process

        -  For eligible subjects, investigator apply Standard Deviation or Comparator on the breast

        -  The Investigational Medical Device is determined by randomization.

        -  Subjects will be applied for 12 weeks.

        -  Subjects will receive Patient Compliance Diary

        -  Subjects will visit the hospital to measure breast volume with VIVID 9i every 2 weeks
           for 16weeks
    

Intervention name(s): EVERA; ESTES
Intervention type(s): Device; Device
Intervention description(s): EVERA apply for 12 weeks; ESTES apply for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: small breast; augmentation; breast volume; External Soft Tissue Expansion System(ESTES)
Study of MORF 057 to Evaluate Single and Multi Ascending Doses in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1a randomized, double-blind, placebo-controlled study to evaluate single and multiple
      ascending doses of MORF-057 in healthy subjects.
    


Intervention name(s): MORF-057; Placebo for MORF-057
Intervention type(s): Drug; Drug
Intervention description(s): SAD: Subjects will be assigned to one of five planned dose cohorts and receive single doses of MORF-057.
Food Effect: Subjects will receive single dose administration of MORF-057 in fed and fasted states.
MAD: Subjects will be assigned to one of three planned dose cohorts and receive multiple doses of MORF-057.; SAD: Subjects will be assigned to one of five planned dose cohorts and receive single doses of placebo.
MAD: Subjects will be assigned to one of three planned dose cohorts and receive multiple doses of placebo.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: MORF-057
Impact of Local Anesthetic Volume During Ultrasound-guided Stellate Ganglion Block
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional

Summary: 
      The purpose of this study was to compare the temperature changes of the upper extremities
      when using local anesthetic of various volume (4ml, 6ml, 8ml) in the ultrasound guided
      stellate ganglion block.
    

Detailed description: 
      One pain physician performs all US-guided stellate ganglion block(SGB)s, who is not involved
      in evaluating study variables. Electrocardiography, noninvasive blood pressure, heart rate,
      and peripheral oxygen saturation were monitored for all patients before, while, and after
      conducting procedure.

      For US-guided SGB, patients are supine positioned, and skin preparation on injection site is
      done with chlorohexidine. Procedure is conducted under ultrasound guidance at C6 level. 4ml,
      6ml, and 8ml of 1% lidocaine is injected for the each group, respectively. Syringes are
      prepared by one nurse who do not involved in other steps of this study.

      Temperature measurement is conducted 4 times (before US-guided SGB and after 10, 20, and 30m
      from SGB) at both hands, face, axillar by one person who's not involved in other measuring in
      the study.
    

Intervention name(s): Stellate ganglion block
Intervention type(s): Procedure
Intervention description(s): Well trained pain physician performs all the ultrasound(US)-guided stellate ganglion block(SGB)s, who is not involved in evaluating study variables. Electrocardiography, noninvasive blood pressure, heart rate, and peripheral oxygen saturation were monitored for all patients before, while, and after conducting procedure. For US-guided SGB, patients are supine positioned, and skin preparation on injection site is done with chlorohexidine. Procedure is conducted under ultrasound guidance at C6 level. 4 ml, 6 ml, and 8 ml of 1% lidocaine is injected for the each group, respectively.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Pharmacodynamics and Tolerance of Nicotinamide Mononucleotide (NMN, 400mg/Day) in Healthy Adults
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the physiological and/or biological actions of
      nicotinamide mononucleotide (NMN-C) in healthy adults receiving a repeated-dose over the
      course of 28 days by studying the tolerance and pharmacodynamics of this product.
    


Intervention name(s): Nicotinamide mononucleotide (NMN-C)
Intervention type(s): Dietary Supplement
Intervention description(s): Nicotinamide mononucleotide (NMN-C) at 400 mg/day for 28 days in total
Intervention MeSH terms: Niacinamide; Niacin; Nicotinic Acids
Intervention model: Single Group Assignment
Intervention model description: Exploratory interventional repeated-dose study, open-label, single-arm, single-center
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: tolerance; Pharmacodynamics
Bioequivalence Study of One Tablet of Paracetamol 1000 mg + Codeine 30 mg vs. Two Tablets of Paracetamol 500 mg + Codeine 30 mg
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the bioequivalence of a new paracetamol 1000
      mg/codeine 30 mg formulation vs. the marketed reference Co-efferalgan® 500 mg/30 mg in terms
      of rate and extent of absorption, when administered as single oral dose (one tablet of the
      new A.C.R.A.F. formulation vs. two tablets of the reference formulation Co-efferalgan®) to
      healthy male and female volunteers, under fasting conditions, in two consecutive study
      periods.
    


Intervention name(s): Paracetamol 1000 mg/codeine phosphate hemihydrate 30 mg tablet; Paracetamol 500 mg/codeine phosphate hemihydrate 30 mg tablet
Intervention type(s): Drug; Drug
Intervention MeSH terms: Acetaminophen; Codeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Paracetamol 1000 mg/codeine 30 mg; Co-efferalgan 500 mg/30 mg
Research Study to Compare the Addition of Topaz Micro Debridement to the Standard of Care Surgery
Condition: Greater Trochanteric Pain Syndrome; Hip Pain Chronic
MeSH terms: Bursitis; Syndrome
Study type: Interventional

Summary: 
      Compare the surgical use of Topaz with the Standard Of Care in the treatment of Greater
      Trochanteric Pain Syndrome (a type of hip pain). The hypothesis is that there is a difference
      between the two treatment groups.
    


Intervention name(s): Topaz; Iliotibial band release and trochanteric bursectomy
Intervention type(s): Device; Procedure
Intervention description(s): Radiofrequency micro debridement with Topaz will be used to treat the gluteal tendons following standard of care procedure; Standard of Care: An iliotibial band release and trochanteric bursectomy will be performed.
Other intervention name(s): Topaz AC-4045-01; Standard of Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Iliotibial Band Release; Trochanteric Bursectomy; Micro debridement
Respiratory Kinematics During Voluntary and Reflex Cough in Healthy Adults
Condition: Cough
MeSH terms: Cough
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Cough is a defensive behavior that involves three stages. A large inspiratory phase, a
      compression phase where the vocal folds close and subglottal pressure is developed, and an
      expiratory phase. Cough serves to protect the upper and lower airways from material such as
      liquids, solids, or saliva, that have been aspirated. There are two types of cough: voluntary
      and reflex cough. Voluntary cough involves a cough to command. Reflex cough is a cough that
      is generated secondary to a stimulus in or near the airway. There has been some research
      regarding the differences between voluntary and reflex cough. However, no research has
      described the differences in airflow or movement pattern (kinematics) between the two types
      of cough. This study seeks to determine the respiratory kinematics and airflow differences
      between voluntary and reflex cough in healthy participants.
    

Detailed description: 
      As a participant, completion of this study will require the following:

      Investigators will first place cotton elastic bands around your chest and abdomen so that
      measures of chest wall and abdominal movements can be measured. Then, tests of your breathing
      made from pulmonary function testing will be completed.

      Investigators will then have you complete a maximum inspiration followed by a maximum
      expiration three times.

      Investigators will ask you to produce a voluntary cough three times into a facemask which is
      attached to a computer.

      Then the investigators will provide you with nebulized water (FOG) through the facemask for
      up to a minute three times. You will have a minute break in between each presentation.

      Finally, the investigators will provide you with a nebulized dose of Capsaicin, which is
      derived from hot peppers, through the same facemask used in all of the above tasks. You will
      receive three doses of capsaicin and be provided with water at any time during the study.
    

Intervention name(s): Healthy adults who receive capsaicin
Intervention type(s): Drug
Intervention description(s): Participants will be seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant will hold a facemask attached to a pneumotachograph, nebulized, and dosimeter. The participant will receive 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants will have a minute in between each presentation and water will be available at all times.
Other intervention name(s): capsaicin
Intervention MeSH terms: Capsaicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: cough
Iodine Status After Intake of Sushi and Seaweed Salad
Condition: Iodine Deficiency
Study type: Interventional

Summary: 
      Seaweed is becoming increasingly popular in the Western part of the world, especially sushi
      wrapped in nori and seaweed salad, also called wakame. There are limited data on the iodine
      content of different seaweed products in the Norwegian Food composition table. Furthermore,
      there is limited available research regarding in vivo bioavailability of iodine from
      seaweeds. The objective of this study is to assess whether iodine from a sushi meal (with
      nori, Porphyra spp), and a wakame salad (Undaria pinnatifida) has similar bioavailability as
      a potassium iodide reference supplement of similar iodine content.
    


Intervention name(s): Sushi and wakame salad
Intervention type(s): Other
Intervention description(s): One serving of mixed sushi and wakame salad
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: seaweed; bioavailability; iodine
Safety, Tolerability, Pharmacodynamic and Pharmacokinetics of 7.5, 10, 12.5 or 15 mg NRL001 in a 2 g Suppository for 14 Days
Condition: Fecal Incontinence
MeSH terms: Fecal Incontinence
Study type: Interventional
Phase: Phase 1

Summary: 
      Healthy subjects will receive NRL001 or placebo once daily for 14 days. The four treatment
      groups, shown below, will each consist of 12 subjects:

      Group 1; Nine subjects will receive a dose of 7.5 mg NRL001 in a 2 g suppository and three
      will receive matching placebo.

      Group 2; Nine subjects will receive a dose of 10 mg NRL001 in a 2 g suppository and three
      will receive matching placebo.

      Group 3; Nine subjects will receive a daily dose of 12.5 mg NRL001 in a 2 g suppository and
      three will receive matching placebo.

      Group 4; Nine subjects will receive a daily dose of 15 mg NRL001 in a 2 g suppository and
      three will receive matching placebo.

      The dosing of each group will be completed prior to the next group being dosed. Dose
      escalation will be dependent on a positive assessment of the safety profile of the preceding
      group by the Safety Monitoring Board.

      The pharmacokinetics of NRL001 will be determined on Days 1, 7 and 14. Pharmacodynamics will
      be examined using a three lead Holter monitor at screening and at intervals throughout the
      study period. Adverse events, vital signs, ECGs and clinical laboratory parameters will be
      collected, tabulated, reviewed and recorded throughout the study.
    


Intervention name(s): NRL001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Rectal suppository Placebo; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Long-term Comparison of Stenting Versus Off-pump Coronary Bypass Surgery
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      The randomized comparison of two strategies in coronary revascularization: bypass surgery
      without the use of a heart lung machine and coronary stenting procedure.

      The comparison comprised the occurrence of cardiac adverse events after the procedure. In
      addition, costs, cognitive outcomes and angiography were assessed.
    

Detailed description: 
      Coronary artery bypass surgery with use of the heart lung machine (on-pump surgery), is
      associated with the risk of peri-operative complications such as death, stroke, myocardial
      infarction, neurocognitive decline, and extended hospitalization. Bypass surgery on the
      beating heart without the use of the heart lung machine (off-pump surgery) has been
      reintroduced in clinical practice in order to reduce these complications. The Octopus cardiac
      wall stabilizer, developed at the UMC Utrecht, facilitates the safe construction of the
      grafts during the off-pump procedure. The expected advantages of off-pump surgery e.g.
      less-invasiveness, complete arterial revascularization, faster recovery and lower costs were
      the basis for the Octostent trial. We hypothesized that the off-pump surgical technique might
      offer an alternative for angioplasty with bare-metal stent-implantation.

      The current study was designed as a randomized controlled multicenter trial comparing two
      strategies.
    

Intervention name(s): Coronary Revascularization
Intervention type(s): Procedure
Intervention description(s): revascularization of coronary arteries in case of symptomatic obstructive coronary artery disease
Other intervention name(s): Stenting; PCI; OPCAB; MICAB
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Symptomatic Coronary Artery Disease Patients
A Phase I Study of Anlotinib on Pharmacokinetics to Assess the Effect of High Fat Diet in Advanced Cancer Patients
Condition: Advanced Cancer
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to further study the pharmacokinetic characteristics of
      Anlotinib in Advanced Cancer Patients with High Fat Diet.
    


Intervention name(s): Anlotinib; Anlotinib
Intervention type(s): Drug; Drug
Intervention description(s): in the fasting state; in the high fat diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Multiple Dose of PK/PD Study of SHR2285 Tablets in Healthy Subjects
Condition: Thrombus
MeSH terms: Thrombosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is a randomized, single-blind, placebo-controlled, multiple-dose escalation Phase I
      trials. 2 dose groups were designed, 12 subjects in each dose group.The drug was administered
      single dose and multiple doses.
    


Intervention name(s): SHR2285 tablet; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: SHR2285 tablet Route of administration: single dose and multiple doses.; Pharmaceutical form: Placebo tablet Route of administration: single dose and multiple doses.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multiple dose of PK/PD Study of SHR2285 Tablets in Healthy Subjects
Masking: Single (Participant)
Primary purpose: Treatment
Effects of Single Oral Dose Dapagliflozin QT Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to examine the effect of dapagliflozin on electronic
      measures of heart beats in healthy males
    


Intervention name(s): Dapagliflozin; Dapagliflozin; Moxifloxacin; Placebo to match moxifloxacin and dapagliflozin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 3 x 50 mg tablets, single oral dose; 2 x 10 mg capsules, single oral dose; Overencapsulated 400 mg capsule, single oral dose; Overencapsulated 400 mg capsule, single oral dose
Other intervention name(s): Avelox™
Intervention MeSH terms: Dapagliflozin; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: QT; Healthy volunteers
Study Of Airway Physiology In Adults. SERETIDE DISKUS® Inhaler and FLIXOTIDE® Inhaler Are Trademarks of GSK Croup of Companies.
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      Comparison of two asthma treatments by lung function measures.
    

Detailed description: 
      Single centre, randomised, double-blind, comparator study to demonstrate superiority of
      salmeterol/fluticasone propionate combination product 50/100mcg bd over fluticasone
      propionate 100mcg bd with respect to improvements in airway physiology (sRAW) in adults with
      persistent asthma treated for 4 weeks.
    

Intervention name(s): Salmeterol/fluticasone propionate and fluticasone propionate
Intervention type(s): Drug
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Inhaled corticosteroids; Asthma