bioihbjkbjnl/mcl2 huggingface dataset:
Study of Individualized Therapies Selection for Patients With Metastatic Colorectal Carcinoma According to the Therapeutic
Condition: Adenocarcinoma of Colon; Adenocarcinoma of Rectum; Metastatic Disease
MeSH terms: Adenocarcinoma; Colorectal Neoplasms; Neoplasm Metastasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the feasibility of selecting personalized therapies
      for colon cancer patients who have failed standard treatments, using a new methodology based
      on the determination of a profile of chemosensitivity by comprehensive genetic expression
      analysis from tumor samples.
    

Detailed description: 
      It is a prospective, randomized study in patients with metastatic colorectal carcinoma
      progressing after two lines of prior therapy. Patients will be randomized (1:1) to receive
      chemotherapy as determined by its oncologist or treatment according to chemosensitivity
      profile obtained. For obtaining the profile a histological tumor sample and a sample of
      venous blood in a tube with heparin standard are necessary . This latter sample will be
      processed to isolate circulating tumor cells by cell adhesion with matrix coated glass
      spheres. The RNA from these circulating tumor cells as well as from tumor cells of tumor
      biopsies from the same patients will be extracted by a standard procedure for extracting RNA
      for genetic expression analysis. Based on the analysis performed on tumor biopsy is generated
      a ranked list of potentially more effective treatments in every case
    

Intervention name(s): Arm A chemotherapy; arm B chemotherapy
Intervention type(s): Drug; Drug
Other intervention name(s): Capecitabine; Cisplatin; Cetuximab; Doxorubicin; Fluorouracil; Gemcitabine; Irinotecan; Topotecan; Mitomycin C; Oxaliplatin; Paclitaxel; Docetaxel; Pemetrexed; Raltitrexed; Sorafenib; Erlotinib; Vinorelbine; Dasatinib; Etoposide; Capecitabine; Cisplatin; Cetuximab; Doxorubicin; Fluorouracil; Gemcitabine; Irinotecan; Topotecan; Mitomycin C; Oxaliplatin; Paclitaxel; Docetaxel; Pemetrexed; Raltitrexed; Sorafenib; Erlotinib; Vinorelbine; Dasatinib; Etoposide
Intervention MeSH terms: Paclitaxel; Etoposide; Vinorelbine; Docetaxel; Albumin-Bound Paclitaxel; Cisplatin; Gemcitabine; Doxorubicin; Liposomal doxorubicin; Capecitabine; Fluorouracil; Oxaliplatin; Irinotecan; Etoposide phosphate; Pemetrexed; Cetuximab; Erlotinib Hydrochloride; Sorafenib; Topotecan; Dasatinib; Mitomycins; Mitomycin; Raltitrexed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Genomic expression profile in tumor samples; Adult patients; metastatic disease status and progression after two lines of systemic therapy
Bone Metabolism After Laparoscopic Gastric Bypass Surgery (BABS)
Condition: Evaluation of Expected Bone Loss After Bariatric Surgery; Possible Prevention of Bone Loss After Surgery by Calcium and Vitamin D Supplementation
MeSH terms: Bone Diseases, Metabolic
Study type: Interventional
Phase: Phase 2

Summary: 
      Bariatric surgery leads to rapid weight loss in female and male patients. Less data are
      available about its impact on bone metabolism.

      The aim of this study is the investigation of changes in bone mineral density,bone
      histomorphometric changes, serum bone turnover markers and changes in body fat and muscle
      composition in patients after laparoscopic gastric bypass surgery.
    

Detailed description: 
      Obese female and male adult patients eligible for laparoscopic gastric bypass surgery
      according to the national Austrian guidelines will be included in this study upon request and
      after patient approval.

      Baseline data collection and quarterly follow up visits are planned to investigate the
      changes in bone mineral density and body composition measured by dual energy X-ray
      absorptiometry as well as the evaluation of serum bone turnover markers of bone formation and
      resorption.

      After surgery subjects will be randomized into two groups:

      Daily oral calcium (500mg) and weekly vitamin D3 supplementation (16.000 IU calciferol)or no
      supplementation of calcium and calciferol.

      A sub-study (approximately 15% of study population) with transiliac bone biopsies will also
      be performed to investigate histomorphometric and histologic changes in bone (biopsy baseline
      and after 24 months).

      The planned duration of the study is 24 months for each subject. Serum bone turnover markers
      will be collected every 3 months, dual energy X-ray absorptiometry measurements will be
      performed every 6 months.
    

Intervention name(s): Calciferol, calcium carbonate
Intervention type(s): Drug
Intervention MeSH terms: Ergocalciferols; Calcium Carbonate; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mass Balance and Metabolism Study of 14C-Z-215
Condition: Healthy Male Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this Phase I study is to determine the absorption, metabolism, and excretion of
      14C-Z-215 in healthy male subjects following a single oral administration at a
      therapeutically relevant dose level (20 mg).
    


Intervention name(s): 14C-Z-215
Intervention type(s): Drug
Intervention description(s): Single oral dose of 20mg Z-215 and 14C-Z-215 solution
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Xenin-25: Novel Regulator of Insulin Secretion and Beta-cell Function
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      An intestinal hormone called Glucose-dependent Insulinotropic Polypeptide (GIP) is released
      into the blood immediately after ingestion of a meal and plays an important role in
      regulating blood sugar levels. However, GIP is not active in persons with type 2 diabetes
      mellitus (T2DM) which is also known as adult onset or non-insulin-dependent diabetes. This
      study is being conducted to determine whether a hormone called xenin-25 can restore the
      activity of GIP in persons with T2DM.
    

Detailed description: 
      Each eligible participant will be administered an oral glucose tolerance test so he/she can
      be assigned to the group with "normal glucose tolerance", "impaired glucose tolerance"
      (between normal and diabetic), or type 2 diabetes mellitus. Each study subject will then be
      administered a meal tolerance test (MTT) on 4 separate occasions. For the MTT, a liquid meal
      (Boost Plus)will be ingested following an overnight fast. A primed-continuous infusion of
      vehicle alone, GIP alone, xenin-25 alone, or the combination of GIP plus xenin-25 (each
      peptide at a dose of 4 pmoles x kg-1 x min-1) will be initiated at the same time the meal is
      ingested. Blood samples will be collected before and during the MTT for the measurement of
      glucose, insulin, C-peptide, glucagon, GIP and xenin-25 levels.
    

Intervention name(s): Placebo; Glucose-dependent Insulinotropic Polypeptide (GIP); Xenin-25; Glucose-dependent Insulinotropic Polypeptide plus Xenin-25
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Intravenous infusion of 1% human albumin in normal saline; Intravenous infusion of GIP (4 pmoles x kg-1 x min-1) in 1% human albumin in normal saline; Intravenous infusion of xenin-25 (4 pmoles x kg-1 x min-1) in 1% human albumin in normal saline; Intravenous infusion of GIP plus xenin-25 (4 pmoles each x kg-1 x min-1) in 1% human albumin in normal saline
Other intervention name(s): Vehicle Alone; GIP; Xenin; GIP plus Xenin
Intervention MeSH terms: Gastric Inhibitory Polypeptide
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Diabetes; Blood Sugar; Xenin-25; GIP; Insulin
Effects of Training in Healthy Sedentary Subjects
Condition: Sedentary Subjects
Study type: Interventional

Summary: 
      The purpose of this study is to understand underlying mechanisms of improved exercise
      tolerance in Healthy Sedentary Subjects after training program.
    

Detailed description: 
      Training protocol used is based on recommendations. A minimum of 20 sessions in 4-6 weeks
      were proposed. The exercise intensity of exercise corresponds to target heart rate at
      ventilatory threshold measured during incremental exercise test. Training at this intensity
      allowed us to individualize effort for each patient.
    

Intervention name(s): Training
Intervention type(s): Other
Intervention description(s): 20 sessions of training
Other intervention name(s): Vt; Mt
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Sedentary
Changes of the Infusion Rate in Insulin Pump Treatment
Condition: Diabetes
Study type: Interventional
Phase: Phase 4

Summary: 
      A pharmacokinetic study of insulin pump treatment using Insulin Aspart. The study consist of
      three different periods A, B and C where a constant the insulin infusion rate is given during
      the periods. In period B and C will the infusion start with a bolus.

      It will be investigated if a steady state of insulin will be obtained faster in period B and
      C then A.
    

Detailed description: 
      A pharmacokinetic study of insulin pump treatment using Insulin Aspart. The study consist of
      three different periods A, B and C where a constant the insulin infusion rate is given during
      the periods. Each period will last 12 hours and blood will be drawn to measure absorbed
      Insulin Aspart. During period A will a constant the infusion rate of insulin be given. In
      period B and C will there at the start of the constant infusion rate be given a bolus. The
      bolus in period C is calculated on the basis of the results in period B, therefore will all
      participants experience period C last where as period A and B is randomized cross-over.
      Period C is written in the protocol as optional and it is evaluated after period A and B if
      period C will be performed.

      The hypothesis is that steady state of insulin will be obtained faster in period B and C than
      A.
    

Intervention name(s): Insulin Aspart
Intervention type(s): Drug
Intervention description(s): A; CSII without bolus: 8 hours of constant insulin infusion. B; CSII with bolus: 8 hours of a constant insulin infusion starting with a s.c. bolus.
C; CSII with bolus, optional: 8 hours of a constant insulin infusion starting with a different bolus than period B. This period is optional and it will be evaluated after period A and B if period C is conducted.
Other intervention name(s): Insulin Aspart/NovoRapid
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Insulin pump treatment CSII; Absorption; Insulin Aspart
Prevenar13 Post Market Surveillance
Condition: Healthy
Study type: Observational

Summary: 
      It is an observational multi-center study to assess the safety profile of Prevenar13 used
      among Korean children in the routine clinical setting following a licensure and introduction
      of the vaccine. This study is designed to fulfill regulatory requirement for any new drug
      authorized by KFDA.
    

Detailed description: 
      non-randomization, non-probability sampling
    

Intervention name(s): 13-valent pneumococcal vaccine
Intervention type(s): Biological
Intervention description(s): 0.5mL IM (Intramuscular administration) as per recommended schedule
Other intervention name(s): Prevenar 13
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All infants and children meeting the usual prescribing criteria for Prevenar 13 as per the
        local product information for usage
Secondary Prophylaxis Gastric Variceal Bleed
Condition: Cirrhosis
MeSH terms: Fibrosis
Study type: Interventional

Summary: 
      The investigators conducted a randomized, controlled trial (RCT) to study the efficacy of
      beta blockers versus endoscopic cyanoacrylate injection in the prevention of gastric variceal
      (GOV2 or IGV1) rebleeding and improvement in survival.
    


Intervention name(s): Endoscopic Cyanoacrylate injection; beta-blocker (propranolol)
Intervention type(s): Procedure; Drug
Intervention description(s): Endoscopic Cyanoacrylate injection in gastric varix; Propranolol was started at a dose of 20 mg twice daily. The principle of incremental dosing was used to achieve the target heart rate for propranolol. The dose was increased every alternate day to achieve a target heart rate of 55/min or to the maximal dose to 360 mg/day if the medication was well tolerated and the systolic blood pressure was >90 mm Hg. On the occurrence of intolerable adverse effects, systolic blood pressure <90 mm Hg or pulse rate <55/min, the dose of the medication was decreased step-wise, and eventually stopped if these adverse events persisted. Reintroduction of the medication was attempted if cessation of the medication did not result in improvement of the reported side-effect.
Other intervention name(s): Glue injection
Intervention MeSH terms: Propranolol; Adrenergic beta-Antagonists
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study Comparing LEO 80190 Ointment With Hydrocortisone Ointment, Both Applied Once Daily in the Treatment of Psoriasis Vulgaris on the Face and Intertriginous Areas
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      An international, multi-centre, prospective, randomised, double-blind, active-controlled,
      2-arm, parallel group, 8-week, phase 3 clinical study in paediatric patients (aged 6 to 17
      years) with psoriasis vulgaris on the face and on the intertriginous areas
    


Intervention name(s): LEO 80190; Hydrocortisone
Intervention type(s): Drug; Drug
Intervention description(s): Applied once daily; Applied once daily
Intervention MeSH terms: Hydrocortisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety of GX-188E DNA Therapeutic Vaccine Administered by Electroporation to Cervical Intraepithelial Neoplasia Grade 3
Condition: Cervical Intraepithelial Neoplasia 3
MeSH terms: Neoplasms; Carcinoma in Situ; Uterine Cervical Dysplasia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to determine maximum tolerable dose (MTD) of GX 188E by defining the safety
      profile the safety and maximum tolerated dose of GX-188E administered by electroporation in
      Cervical Intraepithelial Neoplasia grade 3 (CIN 3) patients.
    

Detailed description: 
      This study is an open-label, dose-escalation, single-center, phase I study to evaluate the
      safety of GX-188E, a DNA-based therapeutic vaccine, administered by electroporation (EP) in
      patients with HPV-16 or HPV-18 associated cervical intraepithelial neoplasia grade 3 (CIN 3).

      Each subject eligible to participate in the trial is given a subject number, which is
      assigned sequentially in ascending order, then allocated to only a single dose level of the
      drug. Three subjects are allocated at each dose level starting with 1mg whereby the dose is
      escalated in sequential subjects in ascending numerical order of subject ID.

      Each subject visit the site three times for administration during the study and is given an
      intramuscular injection of GX-188E at a dose of 1mg, 2mg or 4mg by electroporation at each
      visit

      The subjects conduct the follow-up visits twice, which are 8 weeks and 24 weeks after the
      third injection of GX-188E respectively.
    

Intervention name(s): GX-188E administered by electroporation
Intervention type(s): Genetic
Intervention description(s): Patients will be assigned to three dose groups:1mg, 2mg, and 4mg. Each patient will be administered GX-188E by electroporation in entire study period. The Maximum Tolerated Dose of GX-188E will be determined by the classical 3+3 dose escalation schedule. The number of patients will be ranged from 9 to 18.
Other intervention name(s): Trigrid™ Delivery System
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: 3+3 design; Phase 1; Cervical Intraepithelial Neoplasia; Adult; Safety; Dose Finding
Pulse Pressure Variation Measured During Valsalva Maneuver to Predict Fluid Responsiveness Under Open-chest Condition
Condition: Cardiac Surgical Procedures; Thoracic Surgical Procedures; Sternotomy
Study type: Observational

Summary: 
      Pulse pressure variation (PPV) is a well-known dynamic preload indicator to predict fluid
      responsiveness. However, its usefulness in open-chest conditions has been equivocal. The
      investigators evaluated whether PPV measured during Valsalva maneuver can predict fluid
      responsiveness after sternotomy.
    


Intervention name(s): Valsalva maneuver; Fluid loading
Intervention type(s): Procedure; Other
Intervention description(s): Valsalva maneuver was performed after sternotomy with the constant airway pressure of 30cmH2O for 2 breaths duration.; We record the cardiac index values before and after volume expansion with 6ml/kg of balanced crystalloid
Other intervention name(s): Lung recruitment maneuver; Balanced crystalloid infusion
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult patients undergoing elective off-pump coroanry arterial bypass grafting
A Study of the Effects of Lavender Aromatherapy on Preoperative Anxiety in Breast Surgery Patients
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of lavender aromatherapy on
      preoperative anxiety by measuring changes in pulse rate and anxiety core using Spielberger
      State-Trait Anxiety Index questionnaires and on postoperative pain medicine usage. Study
      participants will then be randomized into one of four groups; either they will receive 2
      drops of lavender (Lavandula Angustifolia) oil (LO) or 2 drops of Michelia Alba Leaf oil (MA)
      or 2 drops of unscented Almond oil (AO) or two drops water on the inside of an oxygen face
      mask for 15 minutes. Linalool makes up ~30% of Lavandula Angustifolia oil and is believed to
      be its most active anti-anxiety component. Before and after treatment, anxiety level will be
      measured using the Spielberger State-Trait Anxiety Inventory.
    


Intervention name(s): Lavandula Angustifolia oil (LO); Michelia Alba Leaf oil (MA); Almond oil (AO); Water
Intervention type(s): Other; Other; Other; Other
Intervention description(s): two drops on the inside of an oxygen face mask for 15 minutes.; two drops on the inside of an oxygen face mask for 15 minutes.; two drops on the inside of an oxygen face mask for 15 minutes.; two drops on the inside of an oxygen face mask for 15 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: Preoperative Anxiety; Breast Surgery; Lavender Aromatherapy
Effects of Autologous Blood Injection Versus Platelet Rich Plasma on Chronic Plantar Fasciitis
Condition: Plantar Fascitis
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Interventional
Phase: Phase 3

Summary: 
      To explore effects of Autologous Blood Injection versus Platelet Rich plasma injection for
      treatment of chronic plantar fasciitis
    

Detailed description: 
      After clinical diagnosis of patients with plantar fasciitis. Patients were divided into two
      groups. Group A (PRP injection group) and Group B (ABI group) were randomized according to
      web based block group randomization. Patients were evaluated prior to injection in terms of
      Health related quality of life scores related to foot and ankle diseases (AOFAS and FADI) and
      VAS. After injection at 1st, 3rd and 6th months HRQoL were compared between groups. Intra
      group evaluation for HRQoL were performed at f/up visits. Independent t test and repeated
      measure ANOVA test used for statistical analysis
    

Intervention name(s): PRP injection; ABI injection
Intervention type(s): Biological; Biological
Intervention description(s): Plantar fascia injection therapy with PRP; ABI injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: heel pain, platelet rich plasm, autologous blood injection
Pivotal Study of the truSculpt Radiofrequency Device for Circumferential Reduction
Condition: Abdominal Fat
Study type: Interventional

Summary: 
      To evaluate the safety and efficacy of the Cutera truSculpt radiofrequency device for
      circumferential reduction.
    

Detailed description: 
      The objectives of this study are to evaluate efficacy and safety of treatment with the Cutera
      truSculpt RF device for circumferential reduction in the abdominal and flank region.
    

Intervention name(s): truSculpt rf device
Intervention type(s): Device
Intervention description(s): radiofrequency device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Efficacy and Safety of Quetiapine Fumarate in the Treatment of Schizophrenic Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to evaluate the efficacy of quetiapine fumarate
      extended-release (XR) used as mono-therapy, administered once daily, in the treatment of
      schizophrenic patient with acute episode.
    


Intervention name(s): Quetiapine Fumarate (SEROQUEL) Extended-Release (XR); Chlorpromazine
Intervention type(s): Drug; Drug
Intervention description(s): 200 mg or 300 mg, oral, single dose; 50 mg, oral, double dose
Other intervention name(s): Seroquel_XR (Quetiapine Fumarate XR)
Intervention MeSH terms: Chlorpromazine; Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Quetiapine Fumarate (SEROQUEL) Extended-Release (XR); qualified PANSS assessment