bioihbjkbjnl/mcl2 huggingface dataset:
Phase II Study of Chemo-Radiotherapy in Patients With Resectable and Borderline Resectable Pancreatic Cancer
Condition: Pancreas Neoplasm Malignant Resectable
MeSH terms: Pancreatic Neoplasms; Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety and effectiveness of a novel neoadjuvant treatment strategy
      incorporating 5-fluorouracil/leucovorin with oxaliplatin ( FOLFOX )chemotherapy in
      combination with chemo-radiation with gemcitabine.
    

Detailed description: 
      The primary objective is to evaluate frequency of achieving complete resection ( RO resection
      )in patients with resectable and borderline resectable pancreatic cancer treated with a
      neoadjuvant regimen of FOLFOX followed by radiation therapy (RT) concurrent with gemcitabine
      chemotherapy at standard dosing.

      Secondary objectives are to determine overall survival and progression-free survival as a
      function of time from study enrollment and to evaluate tolerability and toxicity of protocol
      treatment.

      Eligible patients with resectable and borderline resectable pancreatic cancer will be accrued
      onto protocol therapy, which would include a neo-adjuvant phase followed by surgical
      resection. A cycle of FOLFOX treatment is 14 days. 2 cycles are intended prior to combined
      modality treatment. Combined modality treatment will begin 2 weeks (plus or minus 2 days)
      after the last FOLFOX administration. (Gemcitabine 1000mg/m² will be infused over 30 minutes
      on days 1, 8, 22, and 29 during the 5-week course of radiation treatment. The surgical
      procedure performed will be that required for a complete resection, and this will be based on
      the discretion of the operating surgeon. Patients will be followed for 1 year after
      completion of neoadjuvant therapy or until removal or termination from study, or until death,
      whichever occurs first. Patients will be seen in follow-up ever 3+/- 1 months for 1 year from
      completion of protocol therapy.
    

Intervention name(s): Folfox6; Gemcitabine; Radiation Therapy; Pancreaticoduodenectomy with retroperitoneal lymphadenectomy
Intervention type(s): Drug; Drug; Radiation; Procedure
Other intervention name(s): 5 fluoropyrimidine; Gemzar
Intervention MeSH terms: Gemcitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pancreatic, cancer
Multiple Dose Safety Study of PF-04802540 in Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of
      multiple ascending doses of PF-04802540 administered orally to subjects with schizophrenia.
    


Intervention name(s): PF-04802540; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Multiple ascending doses for 10 days; planned doses include capsules totaling 5 mg and 20 mg every 12 hours, with additional doses determined based on accumulating data; Placebo capsules every 12 hours for 10 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: PF-04802540 multiple dose safety study
A Pilot Investigational Study: Treatment of Anxiety With Non-Needle Electro-Acupuncture
Condition: Anxiety, Mild to Moderate
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effects of non-needle electro-acupuncture on
      mild to moderate anxiety. The hypothesis is that this style of treatment will reduce state
      anxiety and not trait anxiety as measured by the Spielberger STAI test.
    

Detailed description: 
      Persistent and unrelenting stress is defined as anxiety. Anxiety disorders are among the most
      common mental disorders in society. The NIH estimates that nearly 200 million Americans
      suffer from anxiety. Anxiety disorders are associated with a lower quality of life,
      functional impairment and disability, and are also associated with co-morbid physical
      illness.

      Acupuncture, one form of complementary and alternative medicine, has been used to treat
      anxiety. Non-needle acupuncture is one of the safest methods, with none to rare side effects.
      This method has been studied in China (Han 1986) and America (Ulett 1998) Pre-intervention
      testing, then three treatments within one week, will be followed by post intervention
      testing.
    

Intervention name(s): HANS non-needle acupuncture; Stimulation of two acupuncture points bi-lateral
Intervention type(s): Device; Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioavailability of Telmisartan/Amlodipine Fixed Dose Combination in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the effect of food intake on the bioavailability of a fixed dose
      combination of 80 mg telmisartan / 10 mg amlodipine following a high fat breakfast
    


Intervention name(s): Telmisartan/Amlodipine; high fat, high caloric meal
Intervention type(s): Drug; Other
Intervention description(s): Fixed dose combination tablet
Intervention MeSH terms: Amlodipine; Telmisartan; Telmisartan amlodipine combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mild Cognitive Impairment and Endurance Exercise in Parkinson's Disease
Condition: Parkinson Disease; Mild Cognitive Impairment
MeSH terms: Parkinson Disease; Cognitive Dysfunction
Study type: Interventional

Summary: 
      The overall objective of this study is to determine how high intensity endurance exercise
      affects both cognition and the signs and symptoms of Parkinson's disease as well as if
      certain brain structures and functions also change with this exercise.
    

Detailed description: 
      The overall purpose and objective of this project is to test the hypothesis that high
      intensity endurance exercise causes beneficial brain adaptation in patients with mild
      cognitive impairment in Parkinson's disease (PD-MCI). Aim 1 will determine the effect of high
      intensity endurance exercise on cognitive function and other clinical symptoms in PD-MCI. Aim
      2 will determine the effect of high intensity endurance exercise on brain structure and
      function in PD-MCI. Aim 3 will determine the effect of high intensity endurance exercise on
      cortisol in PD-MCI. Aim 4 will determine the effect of high intensity endurance exercise on
      inflammation-related biomarkers found in blood in PD-MCI. Aim 5 will determine the effect of
      high intensity endurance exercise on peripheral levels of neurotrophic factors found in blood
      in PD-MCI.
    

Intervention name(s): High Intensity Endurance Exercise
Intervention type(s): Behavioral
Intervention description(s): Treadmill exercise at 80%-85% maximum heart rate for 30 minutes a day, 3 times per week, for 6 months.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Restoration of Permanent Molars Affected With (MIH) Using Composite Restorations or Preformed Metal Crowns
Condition: Molar Incisor Hypomineralization
MeSH terms: Molar Hypomineralization; Dental Enamel Hypoplasia
Study type: Interventional

Summary: 
      The aim of this study is to compare the clinical outcome of using direct esthetic composite
      restorations in managing MIH cases and the use of preformed metal crowns.
    

Detailed description: 
      Molar incisor hypomineralization can represent a serious and challenging clinical management
      problem. Children with MIH require higher levels of treatment needs and demonstrate
      considerable management problems.

      For most severely affected MIH molars, direct esthetic restorative materials or preformed
      metal crowns will be the treatments to choose between. A number of aspects which could
      support decision-making, however, are not clearly demarcated. First and foremost, it is not
      clear if both treatments are similarly acceptable for patients and providers.
    

Intervention name(s): Direct composite restorations
Intervention type(s): Procedure
Intervention description(s): bulk-fill composite (Filtek BulkFlow, 3M Espe) will be used aftar infiltration or block anaesthesia for affected molar,following by carious tissue removal. Marginal bevelling of enamel will be performed. A universal adhesive (Scotchbond Universal, 3M Espe) will be placed after selective enamel etching A bulk-fill composite will be used and covered using a nanohybrid composite, (Filtek XT, 3M Espe).
Other intervention name(s): composite resin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MIH
Study of the Relationship Between Blood Vessels and Insulin Response in Adolescents
Condition: Diabetes Mellitus, Type 2; Hypertension; Heart Disease; Stroke
MeSH terms: Heart Diseases; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      This study is designed to determine whether there is a relationship between the way insulin
      and blood vessels work. The difference in the interaction between Caucasian and African
      American adolescents will also be examined. This may play a role in the differing rates of
      heart disease and diabetes between the two groups.
    

Detailed description: 
      Purpose: The purpose of the research is to learn more about how the lining of arteries in the
      body (called the endothelium) and insulin work in adolescents. Abnormalities in how the blood
      vessels and insulin work in adolescents may cause high blood pressure, type 2 diabetes,
      stroke and heart disease.

      Healthy adolescents between 8 and 18 years of age are being studied in the Ohio State
      University General Clinical Research Center. Two visits will be necessary. One will be a
      screening visit to determine the child's stage of puberty and obtain a medical history. The
      second will be the study visit. During the latter, blood vessel function will be determined
      by studying the change in forearm blood flow before and after blood flow to the forearm is
      stopped. Insulin sensitivity will be determined using glucose water given into a vein.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adolescents
      
Keywords: insulin sensitivity; endothelial function; adolescence; lipids; puberty
Intravaneous Iron(1000 mg Low Molecular Weight Iron Dextran Over 60 Minutes) for Pregnant Women
Condition: Pregnancy
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the percentage of women who achieve anemia correction after a single dose of
      1000mg of low molecular weight iron dextran(infed).
    

Detailed description: 
      To determine the percentage of women who achieve anemia correction after a single dose of
      1000mg of low molecular weight iron dextran(infed).

      To determine whether IV iron supplementation has a higher satisfaction with treatment as
      compared to oral supplementation in a population previously intolerant of or unresponsive to
      oral iron.

      To evaluate the safety of IV low molecular weight iron dextran in pregnant women.

      To assess maternal and fetal outcomes-preterm delivery, low birth weight deliveries, ER
      visits and hospitalizations related to preterm labor, preterm contractions, ante-partum and
      post-partum transfusions, maternal hemoglobin at post-partum visit after IV iron
      supplementation groups.
    

Intervention name(s): Intravaneous iron(low molecular weight iron dextran)
Intervention type(s): Drug
Intervention description(s): 1000 mg of Iron dextran administered over one hour
Other intervention name(s): Iron Dextran(InFed)
Intervention MeSH terms: Iron; Dextrans; Iron-Dextran Complex
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Iv iron in pregnant women; second and third trimester
Ventilatory Responses to Hypercapnic and Hypoxic Conditions in Hyperventilants
Condition: Hyperventilation Syndrome; Hypercapnia; Hypoxia
MeSH terms: Hyperventilation; Hypoxia; Hypercapnia
Study type: Interventional

Summary: 
      For almost a century, many hypotheses have converged on the idea of altered chemosensitivity
      in patients suffering from hyperventilation syndrome (HVS).

      Given the evolution of current technical equipment and the ability to maximise true positives
      in HVS ( using the revised hyperventilation provocation test), it seems reasonable to
      investigate central and peripheral chemosensitivities in HVS subjects.
    

Detailed description: 
      In the inter-war period, many medical investigators who studied the hyperventilation syndrome
      (HVS) had already questioned the chemosensitivity to CO2 in HVS patients, without being able
      to explore it for all intents and purposes.

      It was subsequently observed that although HVS is not systematically linked to manifest
      resting hypocapnia, it is nevertheless systematically correlated with significant variability
      and complexity of ventilation.

      This is consistent with the observations of an increased plant gain in HVS, to be related to
      an increased loop gain (due to instability of controller gain feedback).

      On the other hand, some authors already noted that, when capnia is chronically compromised in
      HVS, it can be greatly altered by small, transient and barely perceptible increases in VE: a
      10% increase in VE could indeed halve PetCO2, while a sigh would be able to decrease PetCO2
      by up to 15mmHg.

      More recently, teh assumption was made that peripheral chemosensitivity may be impaired in
      HVS patients.

      For all these considerations, it seems reasonable to investigate central and peripheral
      chemosensitivities in identified HVS subjects on the basis of an objective test, such as the
      induced hyperventilation test.
    

Intervention name(s): Hypercapnic hyperoxic ventilatory response; Hypoxic eucapnic ventilatory response
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): The hypercapnic ventilatory response (HCVR) described by Read in 1967 (Read's rebreathing method) is a clinical way to assess the central and peripheric sensitivity to CO2, using a small bag (4-6 l) to achieve prompt equilibrium between the apparatus compartments and the lungs.
By rebreathing a hyperoxic mixture with an initial composition of 70% O2, 7% CO2 and 23% N2, this equilibrium is assumed to be achieved after 15 seconds of rebreathing, when the relationship between VE and PetCO2 has become linear.; The hypoxic eucapnic ventilatory response (HOVR) is a clinical way to assess the peripheric chemosensitivity to O2, using a small bag (4-6 l) to rebreathe a gas mixture initially composed of 20% O2, 0% CO2 and Δ% N2. Eucapnia is achieved by the activation of a CO2 reabsorption cell during the course of the test.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Minimum Effective Volume of Lidocaine Costoclavicular Brachial Plexus Block
Condition: Upper Extremity Surgery
Study type: Interventional

Summary: 
      The aim of this study is to determine the minimum effective volume of lidocaine in 90% of
      patients (ED90) required for single-injection US-guided costoclavicular infraclavicular.
    

Detailed description: 
      The aim of this study is to determine the minimum effective volume of lidocaine in 90% of
      patients (ED90) required for single-injection US-guided costoclavicular ICB. Determination of
      the minimum effective volume of LA is important because it prevents the administration of an
      unnecessarily large (and potentially toxic) dose. Furthermore, when multiple blocks need to
      be performed at the same time in the same patient, knowledge of the minimum effective volume
      allows to the operator to preserve efficacy without sacrificing safety for each block.
    

Intervention name(s): costoclavicular nerve block
Intervention type(s): Other
Intervention description(s): ultrasound-guided costoclavicular nerve block
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Atrial Deganglionation as a Therapy for Cardiac Surgery Patients With Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      A prospective single-arm study of ganglionated plexi ablation in cardiothoracic surgery
      patients with a history of atrial fibrillation.
    

Detailed description: 
      This study assesses the use of electroporation/pulsed field ablation (PFA) to selectively
      ablate ganglionated plexi in cardiothoracic surgery patients with atrial fibrillation. The
      PFA treatment will be performed in up to 12 patients with a history of paroxysmal atrial
      fibrillation. The primary end point will be recurrence of atrial fibrillation out to 1 year
      follow-ups.
    

Intervention name(s): Pulsed Field Ablation of epicardial Ganglionated Plexi.
Intervention type(s): Device
Intervention description(s): Using Pulsed Field Ablation (PFA), delivered via an epicardial catheter, to selectively ablate the ganglionated plexi (GP) on the epicardial surface of the heart.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Comparison of Seated Thoracic Manipulation and Targeted Supine Thoracic Manipulation on Cervical Flexion Motion and Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Thirty-nine patients with cervical spine pain were randomly assigned to either a seated
      thoracic manipulation or targeted supine thoracic manipulation group. Pain and flexion range
      of motion measures were taken before and after the intervention.
    

Detailed description: 
      DESIGN: Randomized clinical trial OBJECTIVES: To determine the effectiveness of seated
      thoracic manipulation versus targeted supine thoracic manipulation on cervical spine pain and
      flexion range of motion. There is evidence that thoracic spine manipulation is an effective
      treatment for patients with cervical spine pain. This evidence includes a variety of
      techniques to manipulate the thoracic spine. While each of them is effective, no research has
      compared techniques to determine which produces the best outcomes.

      METHODS: Thirty-nine patients with cervical spine pain were randomly assigned to either a
      seated thoracic manipulation or targeted supine thoracic manipulation group. Pain and flexion
      range of motion measures were taken before and after the intervention.
    

Intervention name(s): seated thoracic manipulation; supine specific thoracic spine manipulation
Intervention type(s): Other; Other
Intervention description(s): seated general thoracic spine manipulation; supine specific thoracic spine manipulation
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of LY3493269 in Participants With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to determine the side effects related to LY3493269 in
      participants with type 2 diabetes. Blood tests will be performed to check concentrations of
      LY3493269 in the bloodstream. Each enrolled participant will receive LY3493269, dulaglutide,
      or placebo. The study will last up to approximately 16 weeks for each participant and may
      include up to 11 visits.
    


Intervention name(s): LY3493269; Dulaglutide; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered SC; Administered SC; Administered SC
Other intervention name(s): LY2189265
Intervention MeSH terms: Dulaglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Depakote ER in Borderline Personality Disorder
Condition: Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Study type: Interventional

Summary: 
      This study examines the effect of Depakote ER versus placebo in a randomized trial of
      borderline personality disorder. Patients all participate in DBT therapy and those who are
      not responsive are assigned to either Depakote ER or placebo for up to 12 weeks. Borderline
      Personality Symtoms are measured and side-effects are assessed.
    


Intervention name(s): Depakote ER
Intervention type(s): Drug
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Borderline Personality Disorder
Nitazoxanide as a New Local Adjunctive to Nonsurgical Treatment of Moderate Periodontitis
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study was to assess the effect of nitazoxanide delivered subgingivally as
      thermosensitive hydrogel on the clinical and biochemical outcomes of SRP in patients with
      moderate periodontitis.
    

Detailed description: 
      A randomized, controlled clinical trial in a split-mouth design was conducted on forty
      patients equally divided between two groups: a control group treated with full mouth scaling
      and root planing (SRP) and a test group treated with SRP combined with subgingivally
      delivered 0.01% NTZ sustained release Poloxamer 407/hyaluronic acid thermosensitive hydrogel.
    

Intervention name(s): Scaling and Root Planing; Nitazoxanide hydrogel
Intervention type(s): Procedure; Drug
Intervention description(s): Supra- and sub-gingival calculus and debris were removed; Scaling and root planing was performed in combination with the subgingivally delivered thermosensitive Nitazoxanide hydrogel as adjunct antimicrobial therapy.
Intervention MeSH terms: Nitazoxanide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment