bioihbjkbjnl/mcl2 huggingface dataset:
Docetaxel and Gemcitabine in Treating Patients With Progressive Regional or Metastatic Bladder Cancer
Condition: Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter; Urethral Cancer
MeSH terms: Urinary Bladder Neoplasms; Urethral Neoplasms; Carcinoma, Transitional Cell; Kidney Neoplasms; Ureteral Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of docetaxel and gemcitabine in treating
      patients who have progressive regional or metastatic bladder cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine the response rate of patients with progressive regional or
      metastatic transitional cell carcinoma of the urothelium and failure of only 1 prior systemic
      regimen treated with docetaxel and gemcitabine. II. Determine the toxicities of this regimen
      in these patients.

      OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 1 hour followed by
      gemcitabine IV over 30 minutes on days 1 and 8. For patients with complete or partial
      response or stable disease at 3 weeks, treatment repeats every 3 weeks for a maximum of 6
      courses in the absence of disease progression or unacceptable toxicity. Patients are followed
      every 3 months through year 2, every 6 months through year 5, and then annually thereafter
      until disease progression.

      PROJECTED ACCRUAL: A total of 22-45 patients will be accrued for this study over 18-21
      months.
    

Intervention name(s): docetaxel; gemcitabine hydrochloride
Intervention type(s): Drug; Drug
Intervention MeSH terms: Gemcitabine; Docetaxel
Primary purpose: Treatment
Keywords: stage III bladder cancer; recurrent bladder cancer; stage IV bladder cancer; transitional cell carcinoma of the bladder; posterior urethral cancer; metastatic transitional cell cancer of the renal pelvis and ureter; regional transitional cell cancer of the renal pelvis and ureter
Extrahepatic Insulin Resistance in Chronic Hepatitis C
Condition: Insulin Resistance
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis; Insulin Resistance
Study type: Interventional

Summary: 
      In this pilot study, the investigators plan to treat patients with chronic hepatitis C due to
      HCV genotype 3 infection using an interferon-free regimen consisting in the administration of
      ribavirin and sofosbuvir/ledipasvir - a combination of a nucleotide RNA polymerase inhibitor
      with a non-structural protein 5A inhibitor. Patients will undergo a euglycemic
      hyperinsulinemic clamp, using tracers, and indirect calorimetry to assess whether the viral
      suppression induced by this regimen will be capable of reversing the glucose metabolic
      alterations induced by HCV in both the liver and extrahepatic compartments. Adipose and
      muscle tissue biopsies will also be performed to assess some specific molecular changes
      induced by HCV.
    

Detailed description: 
      Epidemiological studies have shown that hepatitis C virus (HCV) infection induces insulin
      resistance, which may progress to type 2 diabetes in susceptible individuals. Despite the
      fact that HCV infects the liver, insulin resistance in these patients appears to originate
      mostly in extrahepatic tissues, particularly in muscles and adipose tissues. The aim of this
      trial is to assess the relative contribution of hepatic vs. extrahepatic tissues to the
      pathogenesis of insulin resistance in chronic hepatitis C. To do so, 20 patients will be
      enrolled in a single-arm, open-label study. Study subjects will include 10 patients without
      any feature of the metabolic syndrome, and another 10 with the metabolic syndrome. All
      patients will receive the same regimen consisting of Ledipasvir 90 mg/Sofosbuvir 400 mg, one
      tablet once a day, associated with body weight-dose adjusted, 200 mg-tablets of ribavirin
      (1,000 mg in two administration in patients <75 Kg of body weight, or 1,200 mg in two
      administrations for those >75 Kg) for 12 weeks. Insulin resistance will be investigated at
      baseline (before treatment) and after 6 weeks of treatment using a euglycemic
      hyperinsulinemic clamp with deuterated glucose: results obtained at 6 weeks - i.e. at the
      time of complete viral suppression - will be compared to basal conditions i.e. before
      antiviral treatment.
    

Intervention name(s): Ledipasvir 90 mg/Sofosbuvir 400 mg; Ribavirin
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration on one fixed dose combination tablet for 12 weeks; Oral administration of body weight-dose adjusted, 200 mg-tablets of ribavirin (1,000 mg in two administration in patients <75 Kg of body weight, or 1,200 mg in two administrations for those >75 Kg) for 12 weeks.
Other intervention name(s): Harvoni; Rebetol
Intervention MeSH terms: Ribavirin; Sofosbuvir; Ledipasvir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Synthetic vs Natural Estrogen in Combined Oral Contraception
Condition: Contraception
Study type: Interventional
Phase: Phase 4

Summary: 
      The main objective of the study is to compare the metabolic effects of natural estradiol and
      synthetic ethinylestradiol used in combined oral contraception in healthy women. A
      progestin-only preparation will be used in comparison. The main goal is to study the effects
      on glucose metabolism, coagulation and a markers of chronic inflammation (such as hs-CRP).
      Our hypothesis is that the natural estradiol preparation will influence blood glucose levels,
      markers of coagulation and chronic inflammation less than the ethinylestradiol preparation.
      The progestin-only preparation will not effect these parameters.
    


Intervention name(s): Ethinyl estradiol / dienogest; Estradiol valerate / dienogest; Dienogest
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One tablet orally for 9 weeks, continuous use; One tablet orally for 9 weeks, continuous use; One tablet orally for 9 weeks, continuous use
Other intervention name(s): Valette, ATC code G03AA; Qlaira, ATC code G03AB08; Visanne, ATC code G03D
Intervention MeSH terms: Dienogest; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Estradiol; Polyestradiol phosphate; Nandrolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Contraception, oral; Ethinyl Estradiol; Estradiol Valerate; Dienogest; Insulin resistance; Chronic inflammation; Coagulation
Hyperbaric Oxygen and Fibromyalgia: Randomised Prospective Clinical Trial
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on
      patients suffering from chronic pain syndrome (Fibromyalgia).
    

Detailed description: 
      The study is a prospective, randomized, cross-over trial. Patients will be randomized into
      two groups (test and control) to receive the HBOT at the beginning of the trial or 2 months
      afterwards. The control group will receive its treatment after the elapsed two months.

      This study will be a prospective, randomized cross over study. After signing a written
      informed consent, all patients will be invited to a 2 hour examination, including pain
      sensitivity examination and a series of questionnaires. In addition, prior to the beginning
      of the treatment all patients will have chest X-ray, neurological examination, cognitive
      evaluation and brain metabolism evaluation (SPECT scan). A similar evaluation will be done
      after the 8 weeks, test versus control time period, and another evaluation will be held after
      16 weeks. The HBOT procedure will be performed in the hyperbaric chamber at Assaf Harofeh
      Medical Center, Israel.

      The following HBOT protocol will be applied for the treated group: 8-week, 5 times a week
      administration of 100% O2 for 90 minutes at a pressure of 2 ATA. After 8 weeks the control
      group, that did not received HBOT, will receive the same HBOT protocols.

      At baseline, after 2 months and after 4 months all patients will undergo complete neurologic
      and pain evaluation and brain SPECT scan (total of 3 evaluation and scan per patient).
    

Intervention name(s): Hyperbaric oxygen
Intervention type(s): Other
Intervention description(s): 8-week, 5 times a week administration of 100% O2 for 90 minutes at a pressure of 2 ATA.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: hyperbaric oxygen; fibromyalgia; chronic pain syndrome
A Study to Evaluate the Relative Bioavailability and Intra-Subject Variability of Two Lots of E5501 40 mg Tablets Administered Twice as Single Oral Doses to Healthy Subjects
Condition: Idiopathic Thrombocytopenia Purpura
MeSH terms: Thrombocytopenia; Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the relative bioavailability (BA) of two lots of
      E5501 40 mg tablets administered twice as single oral doses to healthy subjects.
    

Detailed description: 
      This is a randomized, open label, 4- way crossover, replicate design study to evaluate the
      bioavailability (BA) of E5501 new Phase 3 formulation Lot P97001ZZB 40 mg tablet manufactured
      July, 2009 (Treatment A ,reference drug) relative to Lot P01010ZZA 40 mg tablet manufactured
      January, 2010 (Treatment B, test drug) administered to 42 healthy male and female subjects.
    

Intervention name(s): E5501; Drug: E5501
Intervention type(s): Drug; Drug
Intervention description(s): Lot P01010ZZA (test) single oral doses of 40 mg tablets.; Lot P97001ZZB (reference) single oral doses of 40 mg tablets.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Hormonal Intervention for the Treatment in Veterans With COVID-19 Requiring Hospitalization
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if temporary androgen suppression improves the
      clinical outcomes of Veterans who are hospitalized to an acute care ward due to COVID-19.
    

Detailed description: 
      A novel coronavirus, now termed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2),
      arose late in 2019. The first confirmed cases occurred in December in Wuhan, Hubei province,
      China. It now infects people on six continents, spreading person to person. The World Health
      Organization (WHO) classified it as a global pandemic on March 11, 2020. As of April 6, 2020,
      there are more than 1.2 million confirmed cases and more than 70,000 deaths attributed to
      this virus. Every person on Earth, as well as every United States Veteran, is at risk. This
      is the emergent public health threat of our time.

      SARS-CoV-2 is a singled stranded RNA virus related to severe acute respiratory
      syndrome-related coronavirus (SARS-CoV-1). SARS-CoV-2 is thought to be transmissible largely
      by respiratory droplets or direct contact, but might also be transmitted through
      aerosolization. SARS-CoV-2 disease severity ranges from no to minimal symptoms, mildly
      symptomatic with cough and dyspnea, to severe respiratory distress with multi-organ failure
      requiring admission to an intensive care unit and emergent ventilator support. Although data
      are evolving, the severity of illness varies with age, co-existing comorbidities, and
      biological sex, with older age, people with pre-existing cardiovascular disease, and males
      manifesting greater disease severity.

      A worldwide effort is in place to contain and suppress human-to-human transmission. These
      public-health strategies aim to slow the rate of spread and reduce the burden on critical
      care infrastructure. However, there is also a need effective therapeutics. Vaccine trials are
      underway but potential approvals are at least a year away. Development of new drugs de novo
      to treat SARS2-CoV-2 will likely take even longer. Thus, the most expedient therapeutic
      strategy to confront this pandemic will repurpose existing FDA-approved therapeutics. One
      potential strategy targets viral components directly, using existing antivirals and
      anti-infectives currently used for other diseases. Such efforts include trials of
      hydroxychloroquine, remdesivir, and ribavirin. Another strategy involves targeting the human
      proteins, rather than viral proteins, required for SARS CoV-2 entry and replication.
    

Intervention name(s): Degarelix; Saline
Intervention type(s): Drug; Other
Intervention description(s): Degarelix is an FDA-approved drug for prostate cancer; 09% Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Everolimus- Versus Biolimus-Eluting Stents in All-Comers
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Observational

Summary: 
      This study sought to investigate safety and efficacy of biolimus-eluting stents (BES) with
      biodegradable polymer as compared with everolimus-eluting stents (EES) with durable polymer
      through 3 years of follow-up.
    

Detailed description: 
      A group of 814 consecutive patients undergoing percutaneous coronary intervention (PCI) was
      enrolled between 2007 and 2010, of which 527 were treated with EES and 287 with BES
      implantation. Clinical outcome was compared in 200 pairs using propensity score matching. The
      primary endpoint was a composite of death, myocardial infarction (MI) and target vessel
      revascularisation (TVR) at two-year follow-up.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All consecutive patients treated at our institution with at least one BES or EES
      
Keywords: drug-eluting coronary stent; percutaneous coronary intervention
A Study to Assess the Safety and Pharmacokinetics of an Inhibitor of Poly ADP-Ribose Polymerase-1 (PARP)
Condition: Ovarian Neoplasms; BRCA1 Protein; BRCA2 Protein
MeSH terms: Ovarian Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the safety, tolerability, dose-limiting toxicity (DLT),
      pharmacokinetic-pharmacodynamic profile, and maximum tolerated dose (MTD) of KU-0059436 when
      administered orally to patients with advanced solid tumours. To further evaluate the safety
      and efficacy of KU-0059436 in an expanded cohort of BCRA-enriched population, primarily
      ovarian cancer patients
    


Intervention name(s): KU-0059436 (AZD2281)(PARP inhibitor)
Intervention type(s): Drug
Intervention description(s): oral
Other intervention name(s): Olaparib
Intervention MeSH terms: Olaparib; Poly(ADP-ribose) Polymerase Inhibitors
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: advanced ovarian cancer; BRCA 1 protein; BRCA 2 protein; Poly(ADP ribose)polymerases
ClosureFAST - Radiofrequency Great Saphenous Vein Treatment
Condition: Venous Reflux
Study type: Interventional

Summary: 
      The purpose of this study is to confirm that the ClosureFAST system can be used as an
      alternative to the current ClosurePlus catheter for treating the GSV and to accumulate
      pivotal data for optimization of the operating parameters.
    

Detailed description: 
      The purpose of this study is to confirm that the ClosureFAST system can be used as an
      alternative to the current ClosurePlus catheter for treating the GSV and to accumulate
      pivotal data for optimization of the operating parameters. The results from this study will
      be used to further evaluate the risks and benefits of the ClosureFAST device and to obtain
      clinical evidence that the treatment provides effective and durable clinical outcomes.
    

Intervention name(s): RF ablation (ClosureFAST)
Intervention type(s): Device
Intervention description(s): Segmental RF Ablation with the CLF catheter
Other intervention name(s): CLF; CLosureFAST
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GSV; RadioFrequency
A Pilot, Multi-Center, Patient Preference Study Comparing Two Clindamycin/Benzoyl Peroxide Gels.
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluate patient preference factors comparing two clindamycin/benzoyl peroxide gels. One
      dispensed in a pump presentation, the other in a tube presentation.
    


Intervention name(s): clindamycin 1% / benzoyl peroxide 5% gel pump; clindamycin 1% / benzoyl peroxide 5% tube
Intervention type(s): Drug; Drug
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Malaria: Relative Bioavailability and Food Effect of DSM265
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1 study designed to evaluate the relative bioavailability of a single dose of a test
      formulation, DSM265-TPGS 34% SDD powder in comparison with a reference DSM265 25% SDD powder
      formulation used in early clinical trials.
    

Detailed description: 
      The objective of this study is to compare the relative bioavailability of oral DSM265-TPGS
      34% SDD formulation with that of a reference 25% SDD powder for suspension used in previous
      clinical trials. Another objective of the study is to evaluate the effect of food on
      bioavailability of the DSM265-TPGS 34% SDD formulation.

      The current 25% SDD powder for suspension clinical formulation is a suspension which requires
      reconstitution/administration in 240 mL sucralose based vehicle (for a 400 mg adult dose).
      This volume is too large for paediatric patients with malaria (e.g., translates into a 30 mL
      volume for 0.5-2 yr old patients); also, the dosing vehicle is not commercially viable. The
      new formulation dissolves in a smaller volume of a more common vehicle, water (40 mL for 400
      mg adult dose).
    

Intervention name(s): DSM265-TPGS 34% SDD, 400 mg fasted; DSM265-TPGS 34% SDD, 400 mg fed; DSM265 25% SDD, 400 mg fasted
Intervention type(s): Drug; Drug; Drug
Intervention description(s): New formulation allowing smaller volumes of dissolution in a common vehicle (water), administered to subjects in a fasted state.; New formulation allowing smaller volumes of dissolution in a common vehicle (water), administered to subjects in a fed state.; Reference formulation used in early clinical trials.
Other intervention name(s): DSM265; DSM265; DSM265
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase 1, single-dose, open-label, randomized, parallel group design in healthy adults (males, females of non child bearing potential) in 3 groups of 14 subjects each.
Masking: None (Open Label)
Primary purpose: Other
A Safety and Effectiveness Trial of Spinal Cord Stimulation of the Dorsal Root Ganglion for Chronic Lower Limb Pain
Condition: Chronic Lower Limb Pain
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of the AXIUM
      Neurostimulator System for the treatment of chronic lower limb pain in persons diagnosed with
      Complex Regional Pain Syndrome (CRPS) or Peripheral Causalgia (PC).
    

Detailed description: 
      The ACCURATE study is a prospective, randomized, controlled, multicenter clinical trial
      designed to assess the safety and efficacy of the Spinal Modulation Axium Neurostimulator
      System as an aid in the management of chronic, intractable pain of the lower limbs, including
      unilateral or bilateral pain associated with one of the following conditions: Complex
      Regional Pain Syndrome (CRPS) or Peripheral Causalgia (also referred to as CRPS Type II).

      Enrolled subjects were diagnoses with CRPS or peripheral causalgia; experienced pain for at
      least six months; and failed to achieve adequate pain relief from at least two prior
      pharmacologic treatments.

      All subjects had a temporary trial neurostimulator (TNS). If the subject was a treatment
      success at the end of TNS they were scheduled for the fully implantable neurostimulator (INS)
      implant procedure. If not, subjects were exited from the study.
    

Intervention name(s): AXIUM Neurostimulator System; Control Spinal Cord Stimulation Device
Intervention type(s): Device; Device
Other intervention name(s): DRG Stimulation; SCS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Biological Response of Trauma Patients to Standard Trauma Resuscitation Therapy
Condition: Hemorrhagic Shock
MeSH terms: Shock, Hemorrhagic; Wounds and Injuries
Study type: Interventional

Summary: 
      Overall aim of this work is to evaluate new methods of resuscitation that can be applied by
      front-line responders on the battlefield, in civilian life, or which can be used during
      initial resuscitation in the first fixed facility to which the injured patient is brought.
    

Detailed description: 
      Shock is a leading cause of death among American forces in battle, with many trauma victims
      dying of early hemorrhagic shock or from late septic shock.1 Shock is defined as circulatory
      collapse, when the arterial blood pressure is too low to maintain an adequate supply of blood
      to the body's vital organs and tissues. Specifically, hemorrhagic shock results when blood
      vessels are physically damaged while septic shock results when microbes or microbial products
      enter the blood stream. Despite advances in medical science, including the development of
      improved antibiotics, treatments for hemorrhagic and septic shock have changed little in the
      past 30-40 years. A wounded soldier bleeding on the battlefield, or a trauma victim in the
      United States, is treated today largely as he or she would have been treated in 1970.

      The overall aim of this work is to evaluate new methods of resuscitation that can be applied
      by front-line responders on the battlefield (medical corpsmen, combat medics), in civilian
      life (Emergency Medical System), or which can be used during initial resuscitation in the
      first fixed facility to which the injured patient is brought. This might be a Fire Support
      Specialist (FIST) team in a combat theater or a trauma center in the civilian health care
      system.
    

Intervention name(s): Glutamine; Ringer's Lactate; Placebo (for Glutamine)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intravenous 25 grams once over 6 hours; Intravenous 1 liter once over 6 hours; Given Intravenously in 1 liter Lactated Ringer's
Other intervention name(s): Lactated Rigner's (LR)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hemorrhagic shock; glutamine; trauma resuscitation; department of defense; trauma