bioihbjkbjnl/mcl2 huggingface dataset:
Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor
      cells, either by killing the cells or by stopping them from dividing. Giving more than one
      drug (combination chemotherapy) may kill more tumor cells. It is not yet known which
      chemotherapy regimen is more effective as first-line therapy in treating pancreatic cancer.

      PURPOSE: This randomized phase II/III trial is studying how well combination chemotherapy
      works as first-line therapy in treating patients with metastatic pancreatic cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare the objective response rate in patients with metastatic adenocarcinoma of the
           pancreas treated with oxaliplatin, irinotecan, leucovorin calcium, and fluorouracil vs
           gemcitabine as first-line chemotherapy. (Phase II)

        -  Compare the survival of patients treated with these regimens. (Phase III)

      Secondary

        -  Compare the toxicity of these regimens in these patients.

        -  Compare progression-free survival of patients treated with these regimens. (Phase III)

        -  Compare the overall response rate in patients treated with these regimens. (Phase III)

        -  Compare quality of life of patients treated with these regimens. (Phase III)

      OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment
      arms.

        -  Arm I: Patients receive oxaliplatin IV over 2 hours, irinotecan IV over 1½ hours,
           leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes on day 1 and
           fluorouracil IV continuously over 46 hours on days 1 and 2. Courses repeat every 14
           days.

        -  Arm II: Patients receive gemcitabine IV on days 1, 8, 15, 22, 29, 36, and 43. Beginning
           on day 57, patients receive gemcitabine IV once weekly for 3 weeks (days 57, 64, and
           71). Courses repeat every 28 days.

      PROJECTED ACCRUAL: A total of 348 patients (88 for phase II and 260 for phase III) will be
      accrued for this study.
    

Intervention name(s): fluorouracil; gemcitabine hydrochloride; irinotecan hydrochloride; leucovorin calcium; oxaliplatin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Leucovorin; Gemcitabine; Fluorouracil; Oxaliplatin; Irinotecan; Calcium; Levoleucovorin
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: adenocarcinoma of the pancreas; stage IV pancreatic cancer
WEAR (Wearability and Evaluation of Adjustable Refraction) III
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      Two-month randomized trial comparing three groups.
    

Detailed description: 
      Two-month randomized non-inferiority trial (the margin of non-inferiority is 20%) comparing
      three groups: self-refraction with adjustable glasses, receiving adjustable glasses;
      subjective refraction by an expert refractionist after computer optometry and receiving
      custom standard glasses; subjective refraction by an expert refractionist after computer
      optometry and receiving ready-made glasses. The main outcome of this study is the rate of
      glasses wear on twice-weekly covert evaluation by head teachers. And the continuous teacher
      assessment of wearing study glasses will be calculated as the number of times wearing
      glasses/ Total number of separate observations.
    

Intervention name(s): Adjustable glasses; Custom standard glasses; Ready-made glasses
Intervention type(s): Other; Other; Other
Intervention description(s): The glasses will be used for refraction and wearing within professional instructions.; The custom standard glasses are made by the traditional standards after refraction.; The glasses have been made already before the refraction in the hospital. And they will be chosen by prescription after refraction.
Intervention MeSH terms: Methamphetamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized non-inferiority trial, and the margin of the non-inferiority is 20%.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Myopia; self-refraction; glasses; spectacles
Atrial Fibrillation Detecting Software Gung Atrial Fibrillation Detecting Software
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      Chang Gung Atrial Fibrillation Detection Software is an artificial intelligence
      electrocardiogram signal analysis software that detects whether a patient has atrial
      fibrillation by static 12-lead ECG signals. This study is a non-inferiority test based on the
      control group. The main purpose is to verify whether Chang Gung atrial fibrillation detection
      software can correctly identify atrial fibrillation in patients with atrial fibrillation, and
      can be used to provide a reference for doctors to detect atrial fibrillation.
    

Detailed description: 
      This study is a retrospective study, and the data is from the six hospitals of Chang Gung
      Medical Research Database (CGRD). We collected de-identified static 12-lead electrocardiogram
      (ECG) data from the database during the period of January 1, 2006, to December 31, 2019.

      We created a training set and a testing set of ECG data from the CGRD. Then, we stratified
      and sampled ECG signals from the testing set according to the actual proportion to obtain the
      experimental sample.

      The computer first preliminarily screened and selected ECG data that met the inclusion and
      exclusion criteria, and then numbered them sequentially. A cardiologist confirmed that the
      sampled ECG data did not include exclusion criteria.

      The ECG data were converted into images and interpreted for the presence or absence of atrial
      fibrillation by three cardiologists. Their results were used as the gold standard (reference)
      for this study.

      After determining the experimental standards, the ECG signals were inputted into the Chang
      Gung Atrial Fibrillation Detection software for analysis and interpretation of each ECG data.

      After the software interpretation was completed, the results were compared with the
      interpretations of the physicians, and the primary and secondary evaluation indicators were
      analyzed accordingly.
    

Intervention name(s): Chang Gung Atrial Fibrillation Detecting Software
Intervention type(s): Device
Intervention description(s): This software is expected to be used in clinical testing to interpret the static 12-lead ECG of adults who are over 20 years old and suspected of having atrial fibrillation, detect whether there is a signal of atrial fibrillation, and output the results for clinicians Near-instant auxiliary diagnostic use.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: artificial intelligence
A Phase II Open-Label Study of High-Dose Cytarabine and Clofarabine in Adult Patients With Refractory or Relapsed Acute Myelogenous Leukemia or Refractory or Relapsed Acute Lymphoblastic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as cytarabine and clofarabine, work in different
      ways to stop the growth of cancer cells, either by killing the cells or by stopping them from
      dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

      PURPOSE: This phase II trial is studying clofarabine when given together with cytarabine to
      see how well they work in treating patients with refractory or relapsed acute myeloid
      leukemia or acute lymphoblastic leukemia.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the response rate in adult patients with relapsed or refractory acute myeloid
           leukemia or acute lymphoblastic leukemia treated with high-dose cytarabine followed by
           clofarabine.

      OUTLINE: This is an open-label phase II study. Patients are stratified according to diagnosis
      (acute myeloid leukemia vs acute lymphoblastic leukemia Phase II: Patients receive high-dose
      cytarabine followed by clofarabine (at the dose determined in phase I) on days 1-3.

      After completion of study treatment, patients are followed periodically for up to 5 years.

      PROJECTED ACCRUAL: A total of 39 patients were accrued for this study.
    

Intervention name(s): clofarabine; cytarabine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cytarabine; Clofarabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent adult acute lymphoblastic leukemia; recurrent adult acute myeloid leukemia; adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22); adult acute basophilic leukemia; adult acute eosinophilic leukemia; adult erythroleukemia (M6a); adult pure erythroid leukemia (M6b); adult acute megakaryoblastic leukemia (M7); adult acute minimally differentiated myeloid leukemia (M0); adult acute monoblastic leukemia (M5a); adult acute monocytic leukemia (M5b); adult acute myeloblastic leukemia with maturation (M2); adult acute myeloblastic leukemia without maturation (M1); adult acute myelomonocytic leukemia (M4)
End-stage Renal Disease (ESRD) Pilot Study
Condition: Renal Dialysis
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety of two different doses of a drug
      called BAY1213790 and how well it is tolerated in patients with end-stage renal disease
      (ESRD) undergoing hemodialysis (HD). Approximately 40, with up to 60 study patients will take
      part in the study.
    


Intervention name(s): BAY1213790; 0.9% sodium chloride solution
Intervention type(s): Drug; Drug
Intervention description(s): Single intravenous infusion of BAY1213790 (Two different doses); Single intravenous infusion of Placebo (0.9% sodium chloride solution)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: End-stage renal disease patients undergoing hemodialysis
Effectiveness of Acupuncture for Depressed Patients Taking Antidepressant Medications
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      In this research study, the investigators piloted a uniform acupuncture treatment protocol
      among adults with depression who were taking an antidepressant medication that was providing
      only partial or no symptom alleviation. The study's aims were evaluate the efficacy, safety,
      and tolerability of acupuncture augmentation treatment among this population. The
      investigators hypothesized that acupuncture as an augmentation treatment would be associated
      with a response rate of at least 50%, which the investigators defined as a decrease in
      depressive symptoms from the beginning to the end of the study of 50% or more, and that the
      response would be greater among patients who received acupuncture 2 times per week (vs. 1
      time per week). The investigators also hypothesized that acupuncture would be associated with
      minimal side effects.
    


Intervention name(s): Acupuncture
Intervention type(s): Procedure
Intervention description(s): Our acupuncture treatment protocol included: HT-7 and LI-4 on the hands bilaterally, and ST-36, SP-6, and LR-3 on the legs bilaterally, with gentle manual tonification every 10 minutes; and GV-20 and GV- 24.5 (Yintang), along the midline of the head.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acupuncture; Antidepressant; Augmentation; Depression
Single Dose Escalation Study to Investigate the Pharmacokinetics as Well as Safety and Tolerability of a Concomitant Administration of Nifedipne GITS and Candesartan Tablets Under Fasting Conditions in Healthy Male Subjects in an Open Label, Non-randomized, Sequential Design.
Condition: Clinical Pharmacology
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study was to investigate the pharmacokinetics as well as safety and
      tolerability of a concomitant administration of nifedipine GITS and candesartan tablets under
      fasting conditions in healthy male subjects.
    

Detailed description: 
      -  Treatment period 1: Single oral dose of 30 mg nifedipine GITS and 8 mg candesartan as
           loose combination (Treatment A)

        -  Treatment period 2: Single oral dose of 60 mg nifedipine GITS and 16 mg candesartan as
           loose combination (Treatment B)

        -  Treatment period 3: single oral dose of 60 mg nifedipine GITS and 32 mg candesartan as
           loose combination (Treatment C) Before any study drug administration in each treatment
           period, subjects were fasted from food for at least 10 hours. Subjects continued fasting
           until at least 4 hours after study drug administration. The wash-out phase between
           treatments was 5 days.

      The blood collection period for pharmacokinetics after administration was 48 h. Afterwards,
      subjects were discharged from the ward. A safety follow-up visit was performed approximately
      7 days after the last administration.
    

Intervention name(s): Nifedipine gastrointestinal therapeutic system (GITS) (Adalat LA, BAY a1040) + Candesartan cilexetil
Intervention type(s): Drug
Intervention description(s): Candesartan and nifedipine were administered together as loose combination with 240 mL non-sparkling water in the morning after a fasting period of at least 10 hours.
Intervention MeSH terms: Candesartan; Candesartan cilexetil; Nifedipine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Peritoneal Lavage on Surgery-induced Positive Peritoneal Cytology in Gastric Cancer Patients
Condition: Gastric Adenocarcinoma; Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Surgical manipulation and handling of a tumor may cause dissemination of cancer cells through
      peritoneal cavity after curative gastrectomy. Intra operative peritoneal lavage may have
      preventive effect on positive peritoneal cytology occurred during gastrectomy in patients
      with gastric cancer.
    

Detailed description: 
      Peritoneal dissemination of gastric adenocarcinoma cells is the most frequent cause of death
      in patients with gastric cancer. Spreading of these cells occur by three routes: direct
      seeding via infiltration through gastric wall, via blood vessels and via perigastric
      lymphatic channels disturbed during lymph node dissection. Conversion of negative
      preoperative peritoneal cytology to positive cytology after curative gastrectomy has been
      shown by previous studies.

      Although extensive intra-operative peritoneal lavage (1 L of physiologic saline 10 times) has
      been shown to be an effective method to eliminate cancer cell dissemination during surgery,
      to cause significant improvement in survival after gastrectomy, widespread use of this
      approach has not existed most probably due to its time consuming technical difficulty.
      Therefore,intra-operative peritoneal lavage (1 L of physiologic saline 3 times) may be used
      more frequently during gastric surgery.If it is possible to show effectivity of
      intra-operative peritoneal lavage using a total of 3 L physiologic saline to eliminate cancer
      cell dissemination occurred before or after gastric surgery, use of this approach may gain
      acceptance to decrease risk of peritoneal metastasis.
    

Intervention name(s): pre-gastrectomy peritoneal washing cytology; post-gastrectomy peritoneal washing cytology; post-lavage peritoneal washing cytology
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): sampling of peritoneal washing fluid before gastrectomy; sampling of peritoneal washing fluid after gastrectomy; sampling of peritoneal washing fluid after peritoneal lavage
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peritoneal lavage; Dissemination; Gastrectomy; Cytology; Lavage
Psychodynamic Therapy for Treating Panic Disorder
Condition: Panic Disorder
MeSH terms: Panic Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will determine the effectiveness of a manualized form of brief psychodynamic
      psychotherapy in comparison with applied relaxation training in treating adults with panic
      disorder.
    

Detailed description: 
      This is a randomized controlled trial of a manualized form of brief psychodynamic
      psychotherapy in comparison with applied relaxation training, a less active form of treatment
      in other studies, for adults with primary Diagnostic and Statistical Manual of Mental
      Disorders, Fourth Edition (DSM-IV) panic disorder.

      Forty nine patients who have signed written consent who have primary DSM-IV panic disorder
      have been entered into the study. Randomization has been stratified by presence of major
      depression and use of psychoactive, anti-panic medications. Medications, if present, have
      been held constant. All patients have received 24 sessions of either psychodynamic
      psychotherapy, or applied relaxation training for panic disorder. This study is currently
      closed for recruitment, although final follow-up assessments have yet to be completed.
    

Intervention name(s): PFPP; ART
Intervention type(s): Other; Other
Intervention description(s): Psychoanalytic Psychotherapy for panic disorder; Applied Relaxation Training
Other intervention name(s): Psychodynamic psychotherapy; Applied Relaxation Training; Behavioral Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: panic disorder,; psychodynamic psychotherapy,; efficacy trial
Effect of Atypical Antipsychotic Drugs Olanzapine and Amisulpride on Glucose Metabolism
Condition: Schizophrenia; Diabetes; Insulin Resistance
MeSH terms: Insulin Resistance; Schizophrenia
Study type: Interventional

Summary: 
      Patients suffering from schizophrenia have a high risk to become obese and develop diabetes.
      Risk of obesity is particularly high with some newer schizophrenia drugs, such as clozapine
      or olanzapine. These drugs are called atypical drugs and exert their action in part by
      occupying receptors for serotonin, particularly the 5HT2A receptor subtype. This receptor may
      also interfere with glucose metabolism and insulin action. The purpose of this study is to
      compare an atypical antipsychotic drugs, olanzapine, which acts by occupying the 5HT2A
      receptor, to another antipsychotic drug, amisulpride, which mainly acts through the dopamine
      pathway. Healthy volunteers are recruited and asked to take a single dose of each drug and of
      placebo on separate days. Then, a combined glucose clamp study will be performed in order to
      test the effects of these drugs on insulin sensitivity and insulin secretion.
    

Detailed description: 
      10 male healthy volunteers are recruited. After informed consent, they are admitted to the
      study ward at 10:00 p.m. prior to the study day and kept fasting until the next morning. At
      8:00 a.m. they receive their study medication (olanzapine, amisulpride or placebo).
      Subsequently, measurements of insulin sensitivity and insulin secretion are performed by
      euglycemic hyperinsulinemic clamp technique followed by hyperglycemic clamp.
    

Intervention name(s): Glucose clamp technique; Amisulpride; Olanzapine; Placebo
Intervention type(s): Procedure; Drug; Drug; Drug
Intervention description(s): euglycemic hyperinsulinemic clamp with target blood glucose of 90 mg/dl (5 mmol/l), followed by hyperglycemic clamp, target blood glucose of 180 mg/dl (10 mmol/l) for measurement of insulin sensitivity and insulin secretion; Single dose of amisulpride 200 mg p.o. given at 8:00 a.m.; Single dose of olanzapine 10 mg p.o. given at 8:00 a.m.; Placebo capsules are given at 8:00 a.m.
Intervention MeSH terms: Olanzapine; Amisulpride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: schizophrenia; olanzapine; atypical antipsychotic drugs; amisulpride; diabetes; insulin resistance; insulin secretion; glucose; euglycemic hyperinsulinemic clamp; hyperglycemic clamp
Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin for 12 Weeks (MK-2355-005)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and antiviral activity of IDX184 in
      combination with pegylated interferon and ribavirin in treatment-naïve subjects with genotype
      1 chronic hepatitis C virus (HCV) infection.
    


Intervention name(s): IDX184; Peginterferon alfa-2a (Peg-IFN); Ribavirin (RBV); Placebo
Intervention type(s): Drug; Biological; Drug; Drug
Intervention description(s): IDX184 50 mg tablet administered orally; Peginterferon alfa-2 180 microgram prefilled syringe administered subcutaneously once weekly; Ribavirin 200 mg tablets administered orally as a divided dose twice daily. Total daily dose to administered will be 1000 or 1200 mg based on body weight.; Matching placebo to IDX184 50 mg tablet administered orally
Other intervention name(s): Pegasys
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hepatitis C; HCV; treatment-naive
A Phase I Trial to Investigate the Metabolism and Pharmacokinetics as Well as Safety and Tolerability of a Single Dose BI671800 HEA Administered as an Oral Solution of the Choline Salt in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objectives of the present study are to investigate the basic pharmacokinetics of BI
      671800, its major metabolite CD6384, and 14C-radioactivity, including mass balance, excretion
      pathways and metabolism following a single oral dose of 400 mg [14C]BI 671800 HEA to healthy
      male volunteers. Secondary objectives are to evaluate the safety and tolerability following a
      single oral dose of 400 mg [14C]BI 671800 HEA to healthy male volunteers.
    


Intervention name(s): BI 671800
Intervention type(s): Drug
Intervention description(s): High dose oral drinking solution
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment