bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Efficacy and Safety of Clazosentan in Reversing Cerebral Vasospasm in Adult Subjects With Aneurysmal Subarachnoid Hemorrhage
Condition: Aneurysmal Subarachnoid Hemorrhage
MeSH terms: Subarachnoid Hemorrhage; Vasospasm, Intracranial; Hemorrhage
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and potential therapeutic benefit of use
      of clazosentan in reversing cerebral vasospasm (a narrowing of blood vessels in the brain due
      to the presence of blood in the space around the brain) in patients who have suffered a
      condition known as aneurysmal subarachnoid hemorrhage caused by bleeding onto the surface of
      the brain from a ruptured brain aneurysm
    

Detailed description: 
      Aneurysmal subarachnoid hemorrhage (aSAH) is characterized by bleeding onto the brain surface
      due to a rupture of a pouch or bulge in a brain vessel (called an aneurysm). It is a rare but
      serious condition with a high risk of death. Even patients who have had successful repair of
      the aneurysm remain at risk for developing cerebral vasospasm, which can result in harmful
      conditions related to the lack of oxygen to parts of the brain and death. Cerebral vasospasm
      usually occurs within the first couple of weeks after aSAH, and it is difficult to treat.
      Currently there is no safe, efficacious and widely available treatment. Previous animal
      studies have shown that a new drug under investigation, clazosentan, was able to reverse
      cerebral vasospasm in animal models of SAH. A first trial conducted in a small number of
      patients showed some benefit of clazosentan in reversing established cerebral vasospasm after
      aSAH. Clazosentan has already been evaluated in the prevention of cerebral vasospasm in
      several large clinical trials in aSAH. This current study aims to evaluate if clazosentan is
      effective and safe in the treatment of cerebral vasospasm after aSAH.
    

Intervention name(s): Clazosentan
Intervention type(s): Drug
Intervention description(s): Concentrated solution for intravenous injection
Other intervention name(s): ACT-108475
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: aneurysmal subarachnoid hemorrhage; cerebral vasospasm; clazosentan
A Dose Escalation Study of OMP-52M51 in Subjects With Solid Tumors
Condition: Relapsed or Refractory Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label Phase 1a dose escalation study of single-agent OMP-52M51 in subjects
      with relapsed or refractory solid tumors. Study includes a dose escalation phase and
      expansion phase. Subjects will be assessed for safety, immunogenicity, pharmacokinetics,
      biomarkers, and efficacy.
    


Intervention name(s): OMP-52M51
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Phase 1; Dose escalation; relapsed or refractory; solid tumor
A Feasibility Study of the Cordis Neurovascular Self Expanding Stent System in Intracranial Arteries
Condition: Atherosclerosis; Aneurysm
MeSH terms: Aneurysm; Atherosclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Feasibility study to assess safety of treating patients with self expanding stent in
      intracranial arteries.
    

Detailed description: 
      Feasibility study to assess safety of treating patients with self expanding stent in
      intracranial arteries. Patients will be followed for 6 months with assessments related to
      technical feasibility and adverse events.
    

Intervention name(s): Cordis Neurovascular ENTERPRISE Self Expanding Stent System; Cordis Neurovascular ENTERPRISE Self Expanding Stent System
Intervention type(s): Device; Device
Intervention description(s): Implantation of the device ENTERPRISE used to treat symptomatic stenosis in intracranial arteries.; Implantation of the device ENTERPRISE to treat wide-necked aneurysms
Other intervention name(s): Other Names:; ENTERPRISE Vascular Reconstruction Device (VRD); ENTERPRISE VRD; ENTERPRISE; ENTERPRISE Vascular Reconstruction Device (VRD); ENTERPRISE VRD; ENTERPRISE
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atherosclerosis,Wide Neck Aneurysm
Dextran-based Priming vs. Crystalloid and Mannitol-based Priming Solution in Adult Cardiac Surgery
Condition: Heart Disease
MeSH terms: Heart Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will compare two priming solutions for extracorporeal circulation, one based on
      Dextran 40, one based on crystalloid and mannitol. Primary endpoint is oncotic pressure
      during cardiopulmonary bypass. Secondary endpoints included fluid balance and organ
      functions.
    

Detailed description: 
      This is a prospective, single center, double-blinded, randomized controlled clinical trial.
      Eighty patients are randomized 1:1 to either cardiopulmonary bypass with the dextran-based
      solution or standard priming with Ringer-Acetate and Mannitol.

      Primary endpoint will be oncotic pressure during cardio pulmonary bypass. Secondary endpoints
      include perioperative fluid balance, coagulation, platelet function, postoperative bleeding
      volume, transfusion requirements, renal function, liver function, pulmonary function,
      inflammatory activation and markers for brain and heart injury.

      Blood samples for oncotic pressure measurements will be collected from an arterial line
      before and during surgery. Organ function will be assessed before surgery and 2 hours cardio
      pulmonary bypass.
    

Intervention name(s): A colloid Dextran 40 solution for extracorporeal circulation; Ringer-Acetate and Mannitol
Intervention type(s): Device; Device
Intervention description(s): The oncotic pressure of the PrimECC solution is higher than that of a crystalloid Ringer-acetate/mannitol solution. It should maintain the plasma oncotic pressure during and after cardiopulmonary bypass (CPB). Subsequently, the leakage of fluids from the systemic circulation to the interstitial compartment during CPB can be reduced, and a higher plasma volume and a better fluid balance can be achieved.; Currently clinic standard for priming the CPB circuit.
Other intervention name(s): PrimECC; Standard crystalloid prime
Intervention MeSH terms: Mannitol; Dextrans
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: extracorporeal circulation
Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication
Condition: Helicobacter Pylori Infection
Study type: Interventional
Phase: Phase 4

Summary: 
      The researchers collect treatment-naive H.pylori-positive patients from the outpatient
      clinic. The subjects were randomized to receive a 10-day or 14-day course of quadruple
      eradication therapy. 6-8 weeks after treatment, the subjects will re-take the 13C-urea breath
      test. Calculate the eradication rates, adverse reaction rates, patient compliance and
      cost-effectiveness index of each group.
    

Detailed description: 
      The researchers collect treatment-naive H.pylori-positive patients from the outpatient
      clinic. If the subject meets the selection criteria but not the exclusion criteria, and signs
      an informed consent form, the researchers randomized the subjects in groups: subjects
      received a 10-day or 14-day course of bismuth-containing quadruple eradication therapy. The
      medication of groups are as follows. 6-8 weeks after the eradication treatment, the subjects
      will review the 13C-urea breath test, and the researcher records the results.

      After all subjects were tested, the eradication rates, adverse reaction rates, patient
      compliance and cost-effectiveness index of each group were calculated.

      According to the course of treatment, it is randomized into a 10-day treatment group and a
      14-day treatment group. The two groups of bismuth quadruple regimens are the same, as
      follows:

      Option 1: Amoxicillin + Clarithromycin + Bismuth + Vonoprazan fumarate Option 2: Amoxicillin
      + Tetracycline + Bismuth + Vonoprazan fumarate Option 3: Amoxicillin + Metronidazole +
      Bismuth + Vonoprazan fumarate Three options are selected according to the hospital's
      situation.
    

Intervention name(s): Amoxicillin; Clarithromycin; Tetracycline; Metronidazole; Bismuth Potassium Citrate; Colloidal Bismuth Pectin; Vonoprazan fumarate
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Use according to the drug combination options selected by each center.; Use according to the drug combination options selected by each center.; Use according to the drug combination options selected by each center.; Use according to the drug combination options selected by each center.; Use according to the drug combination options selected by each center.; Use according to the drug combination options selected by each center.; Use according to the drug combination options selected by each center.
Intervention MeSH terms: Amoxicillin; Metronidazole; Clarithromycin; Tetracycline; Potassium Citrate; Bismuth
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This trial is a multi-center, open-label, non-inferiority, randomized controlled trial.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Helicobacter pylori; Bismuth-containing quadruple regimen
Safety & Effectiveness of Clobex Spray, Followed by Calcitriol Ointment in Management of Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objectives of this study are to evaluate the safety & efficacy of consecutive
      treatments of Clobex® Spray and Silkis® Ointment in the management of plaque psoriasis.
    

Detailed description: 
      Same as above.
    

Intervention name(s): clobetasol propionate spray 0.05%; calcitriol ointment
Intervention type(s): Drug; Drug
Intervention description(s): clobetasol propionate spray, 0.05%, applied topically twice daily; calcitriol ointment, 3 µg/g, applied topically, not to exceed 30 g daily
Other intervention name(s): Clobex® Spray 0.05%
Intervention MeSH terms: Calcitriol; Clobetasol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Emotional and Cognitive Self-regulation, an EEG Study
Condition: Complex Posttraumatic Stress Disorder (cPTSD); Dissociative Disorder Not Otherwise Specified (DDNOS); Dissociative Identity Disorder (DID)
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Dissociative Disorders; Conversion Disorder; Dissociative Identity Disorder
Study type: Interventional

Summary: 
      The main goal of the proposed project is to assess treatment-induced changes of
      electrophysiological and psychophysiological correlates of the capacity to regulate emotion,
      executive functions, and clinical measures in individuals with complex posttraumatic stress
      disorder and dissociative disorders in a naturalistic inpatient setting.
    


Intervention name(s): therapeutic treatment (inpatient and outpatient setting)
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Early Versus Delayed Parenteral Nutrition in Abdominal Surgical Patients
Condition: Digestive System Neoplasms
MeSH terms: Digestive System Neoplasms; Gastrointestinal Neoplasms
Study type: Interventional

Summary: 
      Patients will be randomized to early PN group or late PN group at day 3 after abdominal
      surgery. Patients will receive supplemental parenteral nutrition or not within 7 days after
      abdominal surgery. Both groups will receive SPN except 80% of target energy delivered by EN
      or oral or patients are discharged from hospital. The primary and secondary outcomes will be
      collected.
    

Detailed description: 
      Patients after abdominal surgery will attempt enteral nutrition support for 2 days, if she/he
      can not tolerate 30% of target energy, then she/he will be randomized to early PN group or
      late PN group at day 3. Patients in early PN group will receive supplemental parenteral
      nutrition at day 3 while patients in late PN group will not receive supplemental parenteral
      nutrition until day 8 after abdominal surgery. Both groups will receive SPN except 80% of
      target energy delivered by EN or oral or patients are discharged from hospital. The primary
      and secondary outcomes will be collected.
    

Intervention name(s): Parenteral Nutrition
Intervention type(s): Other
Intervention description(s): Patients who can not tolerate 30% of target energy EN will receive supplemental parenteral nutrition at day 3 or at day 8 after abdominal surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parenteral Nutrition; Digestive System Neoplasms; Randomized Controlled Trials; Clinical Outcomes; Postoperative Period
Memantine for Neuroprotection and Cognitive Enhancement Following Traumatic Brain Injury
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to determine if memantine can improve cognitive and
      neuropsychiatric outcomes after severe traumatic brain injury.
    

Detailed description: 
      This is a pilot/feasibility study of memantine in severe traumatic brain injury (TBI)
      persons, employing a randomized, double-blind, placebo-controlled, design. Outcome
      evaluations will occur after 24 weeks of treatment (on medication) and 4 weeks after
      treatment discontinuation.
    

Intervention name(s): Memantine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Day 1 to 3: 10 mg bid memantine. Day 3 to 21: 20 mg bid memantine. Day 21 to 168: 10 mg bid memantine.; Day 1 to 3: 10 mg bid placebo. Day 3 to 21: 20 mg bid placebo. Day 21 to 168: 10 mg bid placebo.
Other intervention name(s): Namenda
Intervention MeSH terms: Memantine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Traumatic Brain Injury; Memantine; Memory
Vitamin D Repletion in Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The reason for doing this research is that people with kidney disease often suffer from heart
      disease. Why this happens is not fully known. A possible cause may be high blood levels of a
      substance made by bacteria called "endotoxin". The blood levels of this substance are high in
      people with medium-level kidney disease.

      We want to know if replacing normal amounts of Vitamin D can help lower the levels of this
      substance. We also want to know if replacing normal amounts of Vitamin D is associated with
      other changes that may help heart disease. We hope that our research will help figure out if
      levels of this substance can be lowered by replacing normal amounts of Vitamin D. Normal
      subjects are enrolled to have a 'control' set for comparison purposes.
    

Detailed description: 
      Your participation in this study requires:

        -  4 visits to the outpatient clinic (including 1 screening visit)

        -  Providing a blood sample (less than 5 tablespoons) and a urine sample at each visit

        -  Taking a test to measure how leaky your gut is. This test requires that you drink a
           small amount of liquid (about 4 ounces) and then collect your urine for 6 hours after
           drinking the liquid.
    

Intervention name(s): Vitamin D3
Intervention type(s): Drug
Intervention description(s): 2 single oral dose of Vitamin D3 30,000 international units and 8 weeks supply of Vitamin D3 (10,000 IU tablets, 3 pills to be taken by mouth as one dose weekly)
Other intervention name(s): Vitamin D
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vitamin D3 repletion; levels of endotoxin; intestinal permeability; accelerated atherosclerosis
The VALIDATE Study of Valsartan for Patients With Early Stage Heart Failure
Condition: Hypertension; Congestive Heart Failure
MeSH terms: Hypertension; Heart Failure
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a study to evaluate the response of patients with hypertension and early stage heart
      failure to valsartan.
    


Intervention name(s): valsartan
Intervention type(s): Drug
Intervention MeSH terms: Valsartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: HYPERTENSION; HEART FAILURE; PEPTIDE; valsartan
Tandospirone Citrate in the Treatment of Patients With Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of comparative high dose
      Tandospirone Citrate in the treatment of patients with generalized anxiety disorder.
    


Intervention name(s): Usual dose treatment of Tandospirone; Comparative high dose of tandospirone treatment
Intervention type(s): Drug; Drug
Intervention description(s): Usual dose treatment of Tandospirone, oral, 30 mg/day; Comparative high dose of tandospirone treatment, oral, 60 mg/day
Intervention MeSH terms: Tandospirone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Generalized Anxiety Disorder
Cinacalcet stUdy for Peritoneal Dialysis Patients In Double Arm on the Lowing Effect OF iPTH Level
Condition: Secondary Hyperparathyroidism
MeSH terms: Neoplasm Metastasis; Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed in order to investigate the effect of cinacalcet in combination with
      routine conventional medical management for treatment of secondary hyperparathyroidism (SHPT)
      and Ca, P control. This study will compare the efficacy of a cinacalcet-based regimen with
      unrestricted conventional care (vitamin D and phosphate binders) for achieving the stringent
      National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI) targets for
      dialysis patients.
    


Intervention name(s): cinacalcet; control
Intervention type(s): Drug; Drug
Intervention description(s): cinacalcet 25mg qd or 50 mg qd; vit D + P binder
Intervention MeSH terms: Cinacalcet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: peritoneal dialysis
Oligodendrocyte Progenitor Cell Culture From Human Brain
Condition: Demyelinating Diseases
MeSH terms: Demyelinating Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Recent developments in the understanding of stem- and progenitor cell differentiation raises
      hopes that brain damage in chronic neurological diseases may become repaired by systemic or
      focal transplantation of such cells. Clinical trials of stem- or progenitor cell
      transplantation in multiple sclerosis are currently premature. The researchers developed a
      protocol for human oligodendrocyte progenitor cell culture from human brain for the treatment
      of demyelinating disease.
    

Detailed description: 
      Oligodendrocyte progenitor cell line were cultures and will be transplanted into the patient
      with Multiple sclerosis.
    

Intervention name(s): Oligodendrocyte progenitor cell culture/craniotomy
Intervention type(s): Procedure
Intervention description(s): Oligodendrocyte progenitor cell culture protocol of Rajavithi Hospital will be apply
Other intervention name(s): Rajavithi Oligodendrocyte progenitor cell culture protocol
Intervention model: Single Group Assignment
Intervention model description: Cell culture
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: All selective craniotomy
Cap/Iri Plus Cetuximab Compared to Cap/ox Plus Cetuximab in Patients With Metastatic Colorectal Cancer.
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      A randomized phase II-study to evaluate the safety and efficacy of capecitabine plus
      irinotecan plus cetuximab compared to capecitabine plus oxaliplatin plus cetuximab in
      first-line treatment of patients with metastatic colorectal cancer.
    


Intervention name(s): capecitabine; irinotecan; oxaliplatin; cetuximab
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Capecitabine; Oxaliplatin; Irinotecan; Cetuximab
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: capecitabine; irinotecan; cetuximab; oxaliplatin; colorectal cancer
A Study Evaluating the Safety and Efficacy of bb1111 in Severe Sickle Cell Disease
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a non-randomized, open label, multi-site, single dose, Phase 1/2 study in
      approximately 50 adults and adolescents with severe SCD. The study will evaluate
      hematopoietic stem cell (HSC) transplantation (HSCT) using bb1111 (also known as LentiGlobin
      BB305 Drug Product for SCD).
    

Detailed description: 
      Subject participation for this study will be 2 years post-transplant. Subjects who enroll in
      this study will be asked to participate in a subsequent long-term follow up study that will
      monitor the safety and efficacy of the treatment they receive for an additional 13 years for
      a total of 15 years post-drug product infusion.
    

Intervention name(s): bb1111
Intervention type(s): Genetic
Intervention description(s): bb1111 is administered by IV infusion following myeloablative conditioning with busulfan.
Other intervention name(s): lovotibeglogene autotemcel; lovo-cel; LentiGlobin BB305 Drug Product for SCD; autologous CD34+ cell-enriched population from patients with SCD that contains HSCs transduced with BB305 lentiviral vector encoding the βA-T87Q-globin gene, suspended in cryopreservation solution
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment