bioihbjkbjnl/mcl2 huggingface dataset:
New Adjuvant Chemotherapy of Asymptomatic Resectable Primary Lesion With Unresectable Liver-limited Metastases
Condition: Colorectal Neoplasms; Neoplasm Metastasis; Liver Neoplasms; Chemotherapy; Maternal, Affecting Fetus
MeSH terms: Neoplasms; Neoplasm Metastasis; Colorectal Neoplasms; Liver Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the survival benefit of pre-operation chemotherapy of primary tumor tesection
      (PTR) compared upfront PTR for colorectal cancer (CRC) patients with an asymptomatic
      resectable primary tumor and synchronous unresectable liver-limited metastases with
      conversion therapy intent.
    

Detailed description: 
      Fast recovery with fewer postoperative complications, prevention of potential tumor-related
      complications during chemotherapy, life quality improvement, and also can alleviate the tumor
      load of patients, are some advantages of PTR that may play a role in improving
      cancer-specific survival. However, it should be pointed out that nearly all the retrospective
      and prospective studies for the beneficial of PTR enrolled more multi-organ metastases mCRC
      patients, and with palliative treatment purpose. As for unresectable colorectal liver-limited
      metastases (CRLMs) with good Eastern Cooperative Oncology Group performance status (ECOG PS),
      the primary objective is to make metastases resectable by high-intensity conversion therapy
      and achieved a state of no-evidence of disease. PTR were preferred performed before
      enrollment in some related RCT studies, including the CELIM study, CAIRO and CAIRO2 studies.
      Pooled-analysis of our two RCT studies, PTR pre or post chemotherapy for these unresectable
      liver-limited metastases patients had less morbidities and no mortalities, but no RCTs have
      focused on survival benefit of pre-operation chemotherapy of PTR for unresectable CRLMs.
    

Intervention name(s): chemotherapy ± targeted therapy
Intervention type(s): Drug
Intervention description(s): Chemotherapy regimen with either mFOLFOX6 plus cetuximab, bevacizumab or mFOLFOX6 alone were allocated, according the RAS genotype and patient affordability.
Other intervention name(s): chemotherapy plus targeted therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Unresectable colorectal liver metastases; Pre-operation chemotherapy; Primary tumor resection; Survival
Effects of a Kappa Agonist on Hot Flashes in Menopausal Women
Condition: Treatment of Menopausal Hot Flashes
MeSH terms: Hot Flashes
Study type: Interventional
Phase: Phase 1

Summary: 
      Studies suggest that kappa agonists (KA) and peripherally restricted kappa agonists (PRKAs)
      may affect thermoregulation. This pilot study has the aim to establish proof of concept
      regarding efficacy of an oral kappa agonist (KA) for the treatment of menopausal hot flashes.
    

Detailed description: 
      To establish proof of concept regarding efficacy of an oral kappa agonist (KA), Pentazocine/
      Naloxone 50/0.5 mg, for the treatment of menopausal hot flashes.

      To gather data in support of a future proposal to study the safety and efficacy of a PRKA, a
      type of KA, for amelioration of menopausal hot flashes.
    

Intervention name(s): Standard Dose Kappa Agonist; Half Dose Kappa Agonist; Placebo
Intervention type(s): Drug; Drug; Other
Other intervention name(s): Pentazocine/Naloxone 50/0.5 mg; Pentazocine/Naloxone 25/0.25 mg
Intervention MeSH terms: Pentazocine; Naloxone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hot flashes; menopause; kappa agonist
Efficacy of β-carotene Biofortified Maize in Reducing Vitamin A Deficiency Among Children
Condition: Vitamin A Deficiency; Low Serum Retinol
MeSH terms: Night Blindness; Vitamin A Deficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this cluster-randomized trial is to examine whether daily consumption of
      β-carotene biofortified maize flour can reduce the prevalence of vitamin A deficiency and
      improve the vitamin A status and among 4-8 year old children in rural Zambia.
    

Detailed description: 
      Vitamin A deficiency is a major public health problem in Zambia, affecting approximately 40%
      of young children. We aim to conduct a cluster-randomised controlled trial in the Mkushi
      region of rural Zambia to test whether feeding children two daily meals containing β-carotene
      biofortified maize flour compared to regular white maize flour-based meals for six months can
      reduce the prevalence of vitamin A deficiency and improve the vitamin A status among 4-8 year
      old children. Five hundred children in each arm will receive 2 meals a day, 6 days a week for
      6 months, after which changes in serum retinol concentrations will be compared. An additional
      arm of 250 children, enrolled from randomly sampled clusters, will not receive the maize
      flour intervention but concurrently followed in order to evaluate overall effects of the
      maize flour feeding scheme on measures of household food security.
    

Intervention name(s): β-Carotene Biofortified Maize Flour; White Maize Flour
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Carotenoids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: beta-carotene biofortified maize; micronutrients; vitamin A; serum retinol; dark adaptation
Study of an Investigational Monoclonal Antibody, VIS410, in Subjects With Uncomplicated Influenza A
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2a randomized, double-blind, placebo-controlled study designed to assess the
      safety and tolerability of an investigational monoclonal antibody, VIS410, in subjects with
      uncomplicated influenza.
    

Detailed description: 
      Subjects will be admitted to an infusion unit for drug administration and observation
      following infusion. The study is designed to compare an infusion of a single high or low IV
      dose of VIS410 against placebo. Subjects will be followed for 100 (±7 days).
    

Intervention name(s): VIS410 low dose; VIS410 high dose; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single intravenous fixed low dose of VIS410; Single intravenous fixed high dose of VIS410; Single intravenous infusion of placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Strength and Strength-ratio of Hip Rotator Muscles at Soccer Players
Condition: Hip Injuries; Muscular Atrophy; Dysfunction
MeSH terms: Muscular Atrophy; Hip Injuries
Study type: Observational

Summary: 
      At this investigation we want to find out whether there is a difference in muscle strength of
      the internal and external rotation hip muscles between soccer players and non-soccer players
      caused by typical movement patterns seen in soccer sport.
    

Detailed description: 
      Nontraumatic hip injuries are a problem often seen in Soccer Players. A biomechanical
      formation mechanism is probably. Little research has focused on the measurement of hip
      external and internal rotation strength at soccer players. The purpose of this study is to
      investigate the influence of soccer sports at the isometric force and force ratio of the hip
      rotator muscle system. Two samples of Athletes will be compared: Soccer Players (N15) and
      Non-soccer players (N15) matched in sex, age and level of physical activity to investigate
      hip rotator force in 3 different angles of hip flexion (0°/45°/90°). The measurement will be
      made with a handheld dynamometer.
    

Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        soccer club of Sarnen, Switzerland Residents of Sarnen and Basel, Switzerland
Stress Hormones and Human Cocaine Use - 7
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the HPA axis and adrenergic system activation in
      response to cocaine administration.
    

Detailed description: 
      The goal of this study was to investigate the role of sympathetic-adrenal medullary (SAM) and
      hy0pothalamo-pituitary-adrenal (HPA) systems in mediating the addictive effects of cocaine. A
      toal of 6 male subjects were enrolled for this 5 day inpatient study. Subjects were assigned
      to either cocaine (32mg /70kg iv) or placebo (saline iv) treatment during the first
      experimental sessions and were crossed over to the alternative treatment during the second
      experimental session. Endpoints that were followed during the experimental sessions included
      neuroendocrine (serum epinephrine, norepinephrine and cortisol levels), physological (heart
      rate/blood pressure, EKG) and subjective measures (Beck Depression Inventory, Craving
      Questionnaire). We hypothesized that cocaine administration would lead to increased blood
      levels of norpinephrine, epinephrine and cortisol in cocaine dependent subjects.
    

Intervention name(s): Cocaine
Intervention type(s): Drug
Intervention MeSH terms: Cocaine
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: cocaine dependence
Oral Versus Parenteral Nutrition Support to Improve Protein Balance in Colorectal Surgical Patients
Condition: Colon Cancer
MeSH terms: Colonic Neoplasms
Study type: Interventional

Summary: 
      A prospective, randomized controlled study, using stable isotope methodology, is proposed to
      determine whether an oral nutrition support regimen, containing pressurized whey protein and
      glucose, is more effective at normalizing the metabolic response to surgery than a standard
      peripheral parenteral nutrition (PPN) support regimen, containing amino acids and glucose, in
      colorectal surgical patients studied before and after surgery. The effectiveness of the
      nutrition support regimens will be determined by: whole body protein balance, synthesis rates
      of hepatic secretory proteins, resting energy expenditure and substrate utilization, as well
      as circulating metabolites concentrations.
    


Intervention name(s): Oral Nutrition with dextrose and pressurized whey protein; Peripheral Parenteral Nutrition
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Ten (10) subjects will be randomly assigned to receive an oral nutrition regimen comprised of 50% of their REE as dextrose and 20% of their REE as pressurized whey protein. Subjects will undergo a six-hour stable isotope infusion protocol one day before surgery (to obtain baseline data) and on the first post-operative day. During both infusion protocols, subjects will be asked to carry out their assigned oral nutrition regimen. To minimize fasting during the perioperative period all subjects will receive peripheral parenteral nutrition (PPN) at the time of surgical incision until the first postoperative day.; Ten (10) subjects will be randomly assigned to receive peripheral parenteral nutrition (PPN) regimen comprised of 50% of their REE as dextrose and 20% of their REE as amino acids. Subjects will undergo a six-hour stable isotope infusion protocol one day before surgery (to obtain baseline data) and on the first post-operative day. During both infusion protocols, subjects will be asked to carry out their assigned PPN regimen. To minimize fasting during the perioperative period all subjects will receive PPN at the time of surgical incision until the first postoperative day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Bowel resection
Modulation of Abeta Levels by GSK933776 in Alzheimer's Disease Patient
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Modulation of beta-amyloid levels in CSF and plasma by GSK933776 in patients with mild
      Alzheimer's disease or mild cognitive impairment
    

Detailed description: 
      This is a phase I, an open label, single dose and parallel group study to assess short term
      pharmacodynamics and safety of GSK933776. The effect on the beta amyloid levels will be
      assessed in early (MCI) and mild Alzheimer's disease (AD) patients after a single dose of
      GSK933776 by i.v. administration.
    

Intervention name(s): GSK933776; GSK933776; GSK933776
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 1mg/kg dose group; 3mg/kg dose group; 6mg/kg dose group
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: CSF sampling; Alzheimer's disease; Amyloid beta levels
The Effects of a Jump Rope Exercise Program on Vascular Health, Inflammatory Markers in Prehypertensive Adolescent Girls
Condition: Prehypertension; Blood Pressure; Abdominal Obesity; Adiposity
MeSH terms: Prehypertension; Obesity; Obesity, Abdominal
Study type: Interventional

Summary: 
      The purpose of this study was to examine the impact of a 12-week jump rope exercise program
      on blood pressure, arterial stiffness, vasodilating and vasoconstricting factors,
      inflammatory markers, and body composition in prehypertensive adolescent girls. Forty
      prehypertensive adolescent girls participated in this study. The girls were randomly divided
      into the jump rope exercise intervention group (EX, n=20) and control group (CON, n=20). The
      EX group performed a jump rope training program at 40-70% of their heart rate reserve (HRR) 5
      days/week for 12 weeks (sessions 50 minutes in duration). The CON group did not participate
      in any structured or unstructured exercise protocol. Blood pressure, arterial stiffness,
      plasma nitrate/nitrite levels, endothelin-1, C-reactive protein, and body composition were
      measured before and after the 12-weeks study.
    


Intervention name(s): Jump rope exercise intervention
Intervention type(s): Other
Intervention description(s): 12-week jump rope exercise program
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: exercise intervention group, control group
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: arterial stiffness; endothelin-1; c-reactive protein; adiposity; exercise; jump rope
A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will evaluate the antipsychotic efficacy of ITI-007 in a randomized, double-blind,
      parallel-group, placebo- and active-controlled, multi-center study in patients diagnosed with
      schizophrenia having an acute exacerbation of psychosis.
    


Intervention name(s): ITI-007; Risperidone; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Clinical Study to Investigate the Effects of Dapagliflozin on Heart Work, Heart Nutrient Uptake, and Heart Muscle Efficiency in Type 2 Diabetes Patients
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomised, placebo-controlled, double-blind, parallel-group, international,
      multicentre, Phase IV study to investigate the effects of dapagliflozin on cardiac substrate
      uptake, myocardial efficiency and myocardial contractile work in T2D patients. Eligible
      subjects with T2D before randomisation and fulfilling all of the inclusion criteria and none
      of the exclusion criteria will be randomised in a 1:1 ratio to dapagliflozin 10 mg or placebo
      once daily and treated for six weeks. The study includes five visits.
    

Detailed description: 
      The following will be assessed at Baseline and at the end of the treatment period;

        1. MRI scanning in order to assess cardiac function and morphology. The MRI scanning will
           be made after fasting for at least 6 hours in the same time of day at all visits. The
           cardiac MRI examination will be performed in accordance with a pre-defined MRI protocol,
           with the total scan time at each visit estimated to 45 minutes. Images from all sites
           will be analyzed centrally at the core-lab using a dedicated software package and
           certified analysts.

        2. CT-PET scanning will be made to assess myocardial function and metabolism, as well as
           fatty acid metabolism in brain, liver and kidney cortex. The CT-PET scanning will be
           made after a fast as well as abstinence from nicotine, alcohol and caffeine for at least
           6 hours at the same time of day at all visits.

             -  A cardiac 11C-Acetate PET/CT examination is performed (IV 400 MBq 11C-Acetate).

             -  A cardiac 18F-FTHA PET/CT examination is performed (IV 150 MBq 18F-FTHA). The
                subject is further examined by PET/CT over the liver, kidney cortex and brain (in
                this order) for uptake of 18F-FTHA. Arterialized venous samples are acquired
                throughout to assess P-NEFA and 18F-FTHA metabolism by metabolite analysis
    

Intervention name(s): dapagliflozin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): dapagliflozin 10mg; placebo to match dapagliflozin
Other intervention name(s): Forxiga 10mg
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Cardiac Linear and Torsional Contractility Measurements With a New Technology: Multi Dimensional Kineticardiography
Condition: Healthy
Study type: Interventional

Summary: 
      This study aims to validate the possibility to track cardiac contractility changes with a new
      technology called 'Heart Kinetic' (HK). HK measurements will be realized and compared
      echocardiography.
    


Intervention name(s): Cardiac contractility assessments with Kino-cardiograph; Cardiac assessment repeatability with Kino-cardiograph
Intervention type(s): Device; Device
Intervention description(s): Cardiac contractility will be assessed with Kino-cardiograph device. Echocardiography will also be used for the experimental arm; Cardiac contractility will be assessed with Kino-cardiograph device only, at different times of the day to assess the repeatability of the measures.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double blind randomized crossover active vs placebo
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Device Feasibility
Acceptance and Commitment Therapy for Chronic Pain in Integrated Primary Care
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      This mixed-methods pilot randomized controlled trial sought to: 1) evaluate implementation of
      a brief Acceptance and Commitment Therapy treatment for chronic pain delivered by an
      integrated behavioral health consultant in primary care; and to 2) explore treatment outcomes
      and their associated mechanisms of change.
    

Detailed description: 
      Background: Most patients with chronic pain obtain their treatment in primary care settings,
      where evidence-based behavioral interventions are not typically provided, despite robust
      evidence for treatments like Acceptance and Commitment Therapy.

      Objective: This mixed-methods pilot randomized controlled trial sought to: 1) evaluate
      implementation of a brief Acceptance and Commitment Therapy treatment for chronic pain
      delivered by an integrated behavioral health consultant in primary care; and to 2) explore
      treatment outcomes and their associated mechanisms of change.

      Design: Mixed-methods pilot randomized controlled trial. Active participants completed one
      30-minute individual Focused Acceptance and Commitment Therapy (FACT) visit followed by 3
      weekly 60-minute group visits and a booster visit 2 months later. An enhanced treatment as
      usual (ETAU) control group received 4 handouts about pain management based on cognitive
      behavioral science. Follow-up research visits occurred during and after treatment, at 12
      weeks (booster visit), and at 6 months. Semi-structured interviews were conducted after the
      last research visit.

      Setting: A small integrated primary care clinic in southwestern U.S. affiliated with an
      academic medical center
    

Intervention name(s): Focused Acceptance & Commitment Therapy (FACT); Enhanced Treatment as Usual (ETAU)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): FACT is a brief form of Acceptance and Commitment Therapy and in this study, FACT focused on increasing patient functioning through connection with valued activities and increased acceptance.; This active control intervention included 4 handouts focused on pain management based on cognitive behavioral science.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic pain; acceptance and commitment therapy; integrated primary care; behavioral health consultant
Combined Therapy With L-Thyroxine and L-Triiodothyronine Compared to L-Thyroxine Alone
Condition: Hypothyroidism
MeSH terms: Hypothyroidism
Study type: Interventional

Summary: 
      The objective of this study was to analyze the features of monotherapy with L-T4 in
      comparison with combined therapy with L-T4 and L-T3 in patients with primary hypothyroidism.
    

Detailed description: 
      We conducted a randomized controlled study with a crossover design in 36 premenopausal women
      with overt primary hypothyroidism (reduced T4 concentration accompanied by increased TSH
      concentration at the time of initial diagnosis) who did not receive thyroid hormones. All
      patients were divided into two groups: patients from Group A (n=20) were randomized to L-T4
      in dose of 1,6 μg per kg, followed by combined L-T4 and L-T3; and 16 women from Group B
      received the combination of L-T4+L-T3 (the dose of L-T4 was reduced by 25 μg and replaced
      with 12,5 μg of L-T3), followed by monotherapy with L-T4. The treatment periods lasted for 6
      months. Patients were examined at baseline and at the end of each treatment period.Blood
      samples were obtained to measure serum TSH, free T4, free T3, lipid profile, osteocalcin.
      Urine samples were collected to measure urinary deoxypyridinoline / creatinine ratio. 24-hour
      ECG-monitoring, osteodensitometry and psychological testing were also performed at baseline
      and at the end of each treatment period.
    

Intervention name(s): thyroxine; thyroxine and triiodothyronine
Intervention type(s): Drug; Drug
Intervention description(s): monotherapy with thyroxine; combination with thyroxine and triiodothyronine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypothyroidism, treatment, thyroxine, triiodothyronine