bioihbjkbjnl/mcl2 huggingface dataset:
Eletriptan Provides Consistent Migraine Relief: Results Of A Within-Patient Multiple-Dose Study
Condition: Migraine Without Aura; Migraine With Aura
MeSH terms: Migraine Disorders; Epilepsy; Migraine without Aura; Migraine with Aura
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluation of headache response at 2 hours for active treated attacks for increasing dose.
    


Intervention name(s): Placebo; Eletriptan HBr 40 mg; Eletriptan HBr 80 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): All subjects will receive open label eletriptan 40 mg per attack for the first three attacks in the phase 1 of the study. For the next 4 attacks subjects will be assigned to either eletriptan 40 mg or 80 mg group based on the response in the phase 1 portion of the study. In phase II, in each group subjects will receive eletriptan 40 mg or 80 mg for 3 attacks and placebo for 1 attack. In each group double-blind placebo will be inserted at random.; All subjects will receive open label eletriptan 40 mg per attack for the first three attacks in the phase 1 of the study. For the next 4 attacks subjects will be assigned to either eletriptan 40 mg or 80 mg group based on the response in the phase 1 portion of the study. In phase II, in each group subjects will receive eletriptan 40 mg or 80 mg for 3 attacks and placebo for 1 attack. In each group double-blind placebo will be inserted at random.; All subjects will receive open label eletriptan 40 mg per attack for the first three attacks in the phase 1 of the study. For the next 4 attacks subjects will be assigned to either eletriptan 40 mg or 80 mg group based on the response in the phase 1 portion of the study. In phase II, in each group subjects will receive eletriptan 40 mg or 80 mg for 3 attacks and placebo for 1 attack. In each group double-blind placebo will be inserted at random.
Intervention MeSH terms: Eletriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study to Evaluate if Inhaled Nitric Oxide Improves Liver Function After Transplantation
Condition: Reperfusion Injury; Liver Injury
MeSH terms: Reperfusion Injury; Wounds and Injuries
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This blinded, placebo-controlled study will administer inhaled nitric oxide to patients
      undergoing liver transplantation. The purpose of the study is to test if inhaled nitric oxide
      prevents liver injury associated with the restoration of blood flow. The premise of the
      current study is provided by previous studies which document a protective effect of inhaled
      nitric oxide in this clinical setting.
    

Detailed description: 
      Specifically, presenting ischemia-reperfusion injury to transplanted livers remains a
      therapeutic goal in improving liver function and potentially expanding the number of
      transplantable livers. This study aims to assess the efficacy of inhaled nitric oxide to
      limit ischemia-reperfusion injury in transplanted livers and by doing so improve liver
      function post transplantation and decrease patient hospital length of stays.
    

Intervention name(s): inhaled nitric oxide; nitrogen gas
Intervention type(s): Drug; Drug
Intervention description(s): inhaled 80ppm for duration of surgery.; inhaled
Other intervention name(s): iNO
Intervention MeSH terms: Nitric Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ischemia-reperfusion; nitric oxide; inflammation; cell-death; Liver-function post transplantation
Comparison of Plaster of Paris Against Tubigrip for the Treatment of Lateral Ankle Sprains
Condition: Ankle Injuries
MeSH terms: Sprains and Strains; Ankle Injuries
Study type: Interventional

Summary: 
      Until now very few studies have been done to compare the efficacy of tubigrips or plaster of
      paris in the treatment of lateral ankle sprains, the investigators aim to compare the
      tubigrip against plaster of paris in the treatment of lateral ankle sprains.
    

Detailed description: 
      200 patients were enrolled after meeting inclusion criteria.All patients gave the verbal as
      well as written consent for inclusion in the study. The hospital committee ethical review
      board gave the permission for this study. Only 126 patients agreed to participate in the
      study. After informed consent was obtained the patients were randomized such that each
      patient was allocated to use either a Tubigrip (Group A) or Plaster of Paris (Group B)using
      the Block randomization. The patients in TG group receive the Tubigrip treatment and the
      patients in POP group were given a below knee plaster cast. Patients were instructed to
      follow up at 2 weeks and then at 6 weeks. The functional score and pain were used as outcomes
      of the study
    

Intervention name(s): Plaster of Paris/ Tubigrip
Intervention type(s): Procedure
Intervention description(s): After informed consent was obtained the patients were randomized such that each patient was allocated to use either a Tubigrip (Group A) or Plaster of Paris (Group B). The standardized treatment in the form of RICE (Rest, Ice, Compression and Elevation) protocol was given to all patients. The Patients were randomized using the Block randomization. One hundred and twenty six white papers were taken and "TG" for Tubigrip and "POP" for Plaster of Paris were written and the patients were allowed to pick the envelope of their choice. The authors were blinded till the opening of the envelope by the patients. Patient's usage of analgesia in form of Paracetamol was specifically noted. The patients in TG group receive the Tubigrip treatment and the patients in POP group were given a below knee plaster cast. Patients were instructed to follow up at 2 weeks and then at 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lateral Ankle Sprain; Plaster of Paris; Tubigrip
Study of Efficacy, Safety and Tolerability of ACZ885 (Canakinumab) in Patients With Pulmonary Sarcoidosis
Condition: Pulmonary Sarcoidosis
MeSH terms: Sarcoidosis, Pulmonary; Sarcoidosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess if ACZ885 will improve lung function in association
      with reduction of tissue inflammation in patients with chronic sarcoidosis.
    


Intervention name(s): ACZ885; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ACZ885 will be administered subcutaneously to assigned study subjects once monthly for 6 months.; Placebo will be administered subcutaneously to assigned study subjects once monthly for 6 months.
Other intervention name(s): Canakinumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: pulmonary sarcoidosis; sarcoidosis; canakinumab; autoimmune diseases; granulomas; inflammation; lung function testing; immunosuppressive agents; interleukin; interleukin-1Beta; [F-18]FDG-PET/CT; respiratory; pulmonary; steroids; corticosteroids; lung diseases
Clinical Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LEZ763
Condition: Type II Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is a three part study to assess the safety and efficacy of LEZ763 on normal
      healthy volunteers and patients with Type 2 Diabetes.
    


Intervention name(s): Placebo; Sitagliptin; LEZ763
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo will be given orally once daily for 28 days to patients assigned to placebo in a randomized and blinded manner; Sitaglitpin will be given orally once daily for 28 days to patients assigned to this treatment in a randomized and blinded manner; LEZ763 will be given orally once daily for 28 days in a randomized and blinded manner
Intervention MeSH terms: Sitagliptin Phosphate
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy volunteers,; Diabetes; Glucose; Pharmacokinetics
Safety and Effect of Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With Spinal Cord Injury
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to investigate the efficacy and safety of autologous
      transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with
      spinal cord injury
    


Intervention name(s): Autologous Adipose Tissue derived MSCs Transplantation
Intervention type(s): Procedure
Intervention description(s): Intravenous injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 2x10e8 cells / 20mL Intrathecal injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 5x10e7 cells / 2mL Into a spinal cord injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 2x10e7 cells / 1mL
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Trial Comparing Metabolic Efficiency of Islet Graft to Intensive Insulin Therapy for Type 1 Diabetes's Treatment
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      Efficacy of pancreatic islet transplantation at 6 months compared to an intensive insulin
      therapy for 2 categories of patients: patients with unstable diabetes and patients who
      underwent kidney transplantation.
    

Detailed description: 
      Efficacy of pancreatic islet transplantation at 6 months compared to an intensive insulin
      therapy for 2 categories of patients: patients with unstable type 1 diabetes versus patients
      with unstable type 1 diabetes and who underwent kidney transplantation.
    

Intervention name(s): Islet Graft
Intervention type(s): Biological
Intervention description(s): Iterative injection of pancreatic islets (minimum: 250,000 IEQ / injection or 3500 IEQ / kg / injection) with a threshold required total of 11,000 IEQ / kg in 2 or 3 injections per patient)
Other intervention name(s): human pancreatic islet transplantation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Islet Cell Transplantation; Metabolic Diseases; Endocrine System Diseases
A Trial to Learn More About Repeated Monthly Injections of Lu AG09222 in Participants With Allergies to Grass Pollen
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 1

Summary: 
      The main goal of this trial is to learn more about the safety of repeated dosing with Lu
      AG09222. The trial doctors will keep track of the participant's overall health by asking them
      how they are and by analyzing blood and urine samples.
    


Intervention name(s): Lu AG09222; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Lu AG09222 will be administered per schedule specified in the arm description.; Placebo matching to Lu AG09222 will be administered per schedule specified in the arm description.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Rollover Study Protocol for Pediatric Patients in South Africa for Continued Access to Emtricitabine
Condition: HIV-1 Infection
MeSH terms: Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objectives of this trial are to provide FTC-203 study participants in South
      Africa with continued access to the study drug, emtricitabine (FTC), following completion of
      the FTC-203 study and to collect long-term safety information in participants receiving
      emtricitabine in combination with other antiretroviral agents.
    


Intervention name(s): Emtricitabine
Intervention type(s): Drug
Intervention description(s): 6 mg/kg capsule once daily, up to a maximum dose of 200 mg once daily, or 10 mg/mL oral solution once daily, up to a maximum of 240 mg once daily
Intervention MeSH terms: Emtricitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: HIV-1 infection; emtricitabine; pediatrics; pediatric patients
Goal Directed Therapy After Aneurysmal Subarachnoid Haemorrhage
Condition: Aneurysmal Subarachnoid Haemorrhage; SAH
MeSH terms: Subarachnoid Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      The objective of this study is to determine whether a goal-directed therapy can reduce the
      incidence of delayed cerebral ischaemia after aneurysmal subarachnoid haemorrhage.
    

Detailed description: 
      The aneurysmal subarachnoid haemorrhage (SAH) is a frequent and dangerous worldwide cause for
      stroke. A typical complication presents delayed cerebral ischemia as a consequence of
      cerebral vasospasms, which occurs in 46% of the cases. The Triple-H-therapy (Hypervolaemia,
      Hypertension and Haemodilution) was favoured to prevent ischaemic complications after
      vasospasm for a long time. However recently, the focus is mainly on hypertension, and it is
      recommended to maintain normovolaemia. The debate how to assure normovolaemia is still on
      going, therefore, this study was designed to examine whether a PiCCO-controlled haemodynamic
      monitoring and a goal-directed therapy can reduce the incidence of delayed cerebral ischaemia
      after SAH.

      The present study is a prospective randomized controlled clinical study. Patients older than
      18 years with an aneurysmal SAH will be enrolled. They will be divided into two groups: a
      control group "C" and a PiCCO group "P". Both groups will be treated according to the current
      guidelines. In addition, in group P the volume and catecholamine therapy will be controlled
      by means of PiCCO-controlled monitoring and an algorithm.

      The primary end point is the number of occurred delayed cerebral ischaemia per patient.
      Secondary end points are neurological, pulmonary, cardiovascular, renal, and hepatic
      complications as well as electrolyte and serum glucose disturbance, sepsis, and mortality,
      length of hospital and intensive care unit stay and the amount of volume and catecholamines
      administered.

      All participants are to be contacted three months after discharge, and their health status is
      to be determined by using the GOS (Glasgow Outcome Scale).
    

Intervention name(s): PiCCO
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Subarachnoid Haemorrhage (SAH); vasospasm; delayed cerebral ischaemia (DCI); goal directed therapy (GDT); Pulse Contour Cardiac Output (PiCCO)
Phase I Study of Safety, Tolerability, and Pharmacokinetics of Viracept in HIV-1 Infected Children and Exposed Infants
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the single dose pharmacokinetic profile of Viracept pediatric powder formulation
      administered to HIV infected or exposed children and infants (0 to 13 years of age). An
      evaluation of the relative bioavailability of the pediatric powder formulation vs. a standard
      tablet formulation in older children (7 to 13 years of age) will also be conducted.
    

Detailed description: 
      This is a study of the safety, tolerability and pharmacokinetics of a Viracept pediatric
      powder formulation with milk or formula. First a single dose will be administered. After the
      patient population is divided into 4 groups by age, an optimal dose will be determined for
      each group. This optimal dose will be given 3 times a day for a 6 week primary observation
      period, plus an optional 6 month extension.

      NOTE: During the single dose portion of this study, patients may be untreated or may continue
      treatment with their current nucleoside antiretroviral therapy. During multiple dose
      administration of Viracept, antiretroviral therapy will be intensified by either adding or
      modifying therapy. Antiretroviral therapies will be limited to those currently licensed
      including zidovudine, lamivudine, stavudine, didanosine or zalcitabine.
    

Intervention name(s): Nelfinavir mesylate
Intervention type(s): Drug
Intervention MeSH terms: Nelfinavir
Primary purpose: Treatment
Keywords: Biological Availability; HIV Protease Inhibitors; Dosage Forms; Nelfinavir
Autologous Stem Cell Transplant for Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Multiple sclerosis is an autoimmune disease. We are studying whether high dose chemotherapy
      and autologous stem cell transplant can replace the autoreactive immune system and if this
      reduces clinical inflammatory disease in the central nervous system (CNS). A second goal is
      to examine whether there is long-term stabilization or improvement in disability scores if
      the inflammatory disease is controlled.
    


Intervention name(s): immuno-ablation and autologous CD34 selected hematopoietic stem cell transplantation (HSCT),; Standard Therapy
Intervention type(s): Other; Other
Intervention description(s): Stem Cell Mobilization with Cyclophosphamide 4.5 gm/m2 and rhGCSF 10 ug/kg/d x 10 day.
Stem Cell Collection with Cobe Spectra Stem Cell Purification with Miltenyi CliniMACS Stem Cell Transplant Conditioning with Busulphan 9.6 mg/kg iv, Cyclophosphamide 200 mg/kg iv, rabbit ATG 5 mg/kg iv followed by CD34 selected autologous hematopoietic stem cell transplant; Patient will receive standard therapy as decided upon by their treating neurologist.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: immunoablation; stem cell transplantation
The Bioavailability of Multiple Novel, Sustainable, Non-animal Derived Protein Sources
Condition: Healthy Aging
Study type: Interventional

Summary: 
      The progressive age-related loss of muscle mass is termed sarcopenia. Consequences of
      sarcopenia are, but not limited to, decreased muscle strength, frailty, and an increased risk
      for the development of chronic metabolic diseases. Impaired postprandial protein digestion
      and amino acid absorption with advancing age has been suggested to be a key mechanism
      underlying sarcopenia. To overcome age-related skeletal muscle atrophy, sufficient dietary
      protein intake is required. However, the production of animal-based protein sources, such as
      milk, is associated with a number of economic, environmental, and ethical issues.
      Accordingly, there is a need to develop sustainable dietary protein sources to support our
      nutrition. Mycoprotein, spirulina, chlorella, pea, and lupin are novel, sustainable,
      non-animal derived protein sources that may represent potential alternative protein sources.
      However, the efficacy of these sources to stimulate muscle mass growth in both young and
      older adults is unknown.

      Therefore, the present study will investigate the postprandial bioavailability of
      mycoprotein, spirulina, chlorella, pea, and lupin protein when compared to the animal-derived
      milk protein. Moreover, postprandial protein handling of these novel protein sources across
      different ages will be assessed. Briefly, 12 healthy young, and older adults will visit the
      University for 6 separate test days, with each day lasting 6 hours. Participants will consume
      the one of the 6 protein drinks on each test day. Repeated blood sampling will be used to
      assess protein digestion and subsequent systemic amino acid appearance.
    


Intervention name(s): Protein ingestion
Intervention type(s): Dietary Supplement
Intervention description(s): Ingestion of various sustainable non-animal derived protein sources compared to animal-based milk protein.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Protein digestion; Amino acid absorption; Bioavailability
Effect of Anesthesia Induction on Cerebral Hemodynamic in Children
Condition: Anesthesia; Reaction; Children, Only
Study type: Observational

Summary: 
      General anesthesia induces hemodynamic changes, notably a reduction of arterial blood
      pressure going up to 30%, that may impact cerebral perfusion and oxygenation.The purpose of
      this study is to assess the impact of anesthesia on the cerebral oxygenation, the perfusion
      of the brain (assessed with transcranial doppler), and the depth of anesthesia in children
      between 6 months and 5 years old during the induction of general anesthesia (induced with
      sevoflurane and/or IV agents). It is expected that the cerebral hemodynamic will be
      maintained despite systemic variations.
    


Intervention name(s): General anesthesia
Intervention type(s): Procedure
Intervention description(s): Children under general anesthesia for an elective surgery, aged between 6 months and 5 years old, ASA 1-2.
Intervention MeSH terms: Anesthetics
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children under general anesthesia for an elective surgery, aged between 6 months and 5
        years old, ASA 1-2.
      
Keywords: General anesthesia; Children
Pain After Endoscopic Submucosal Dissection
Condition: Gastric Neoplasm
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      Endoscopic submucosal dissection (ESD) is widely used for local treatment of gastric
      neoplasms. Although ESD-related complications such as bleeding and perforation have been
      reported, data is currently lacking on the development of pain, which is one of the most
      common adverse events after ESD. Therefore, in the present study, we investigated the
      incidence and clinicopathologic risk factors of pain after ESD.
    

Detailed description: 
      A prospective randomized controlled study was conducted evaluating 156 patients with gastric
      neoplasms treated by ESD at Gangnam Severance Hospital between April 2011 and December 2014.
      All subjects were randomly assigned to treatment with intravenous proton pump inhibitor (PPI)
      either before or after ESD.
    

Intervention name(s): proton pump inhibitor
Intervention type(s): Drug
Intervention description(s): ). In the pre-ESD therapeutic group, a standard intravenous dose of PPI was given 2 hours before ESD. In the post-ESD therapeutic group, patients also received intravenous PPI in standard doses, once in the evening after ESD.
Intervention MeSH terms: Proton Pump Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention