bioihbjkbjnl/mcl2 huggingface dataset:
A Randomized Prospective Clinical Trial of Fel d 1 Peptide Immunotherapy
Condition: Cat Allergy; Cat Hypersensitivity
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this study is to identify changes in cells that are related to the treatment with
      Cat-PAD (ToleroMune Cat).
    

Detailed description: 
      Cat-PAD is an experimental cat allergy vaccine and has been studied to determine if it can
      reduce symptom scores of participants exposed to cat allergen. To study how the vaccine
      causes changes in the immune system, the researchers plan to evaluate changes in the blood
      (genes and proteins) and urine in response to the Cat-PAD vaccine.
    

Intervention name(s): Cat-PAD; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The assigned study intervention will be administered by intradermal injection into the flexor surface of the forearm.; The assigned study intervention will be administered by intradermal injection into the flexor surface of the forearm.
Other intervention name(s): ToleroMune Cat; Cat-PAD Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Allergic rhinoconjunctivitis
Multiple Arm Study of Sebacia Microparticles in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      Prospective, multicenter study with multiple arms to examine the safety and effectiveness of
      the Sebacia Acne Treatment System for the treatment of acne vulgaris.
    


Intervention name(s): Sebacia microparticle and laser treatment; Vehicle and laser treatment
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
BEKINDA (Ondansetron 24 mg Bimodal Release Tablets) for Vomiting Due to Presumed Acute Gastroenteritis or Gastritis
Condition: Gastroenteritis; Gastritis
MeSH terms: Gastroenteritis; Gastritis; Vomiting
Study type: Interventional
Phase: Phase 3

Summary: 
      Randomized, Placebo-Controlled, Phase 3 Trial of RHB-102 (BEKINDA) (Ondansetron 24 mg Bimodal
      Release Tablets) for Acute Gastroenteritis.

      The study will evaluate the safety and efficacy of RHB-102 (BEKINDA) in treating Acute
      Gastroenteritis, by comparing it to placebo.
    

Detailed description: 
      Randomized, Placebo-Controlled, Phase 3 Trial of RHB-102 (BEKINDA) (Ondansetron 24 mg Bimodal
      Release Tablets) for Acute Gastroenteritis.

      The study will evaluate the safety and efficacy of RHB-102 (BEKINDA) in treating Acute
      Gastroenteritis, by comparing it to placebo.
    

Intervention name(s): RHB-102; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): RHB-102, Bimodal Release Ondansetron Tablets; Placebo
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gastroenteritis; Gastritis; Vomiting; Nausea; Diarrhea
Food Effect Study For New Formulation
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this study is to estimate the effect of food on sildenafil
      pharmacokinetics after administration of Powder Oral Suspension (POS) formulation of
      sildenafil citrate.
    


Intervention name(s): sildenafil citrate; sildenafil citrate
Intervention type(s): Drug; Drug
Intervention description(s): 2 mL of POS formulation of sildenafil citrate 10 mg/mL (equivalent to 20 mg dose), single dose; 2 mL of POS formulation of sildenafil citrate 10 mg/mL (equivalent to 20 mg dose), single dose
Intervention MeSH terms: Sildenafil Citrate; Citric Acid; Sodium Citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Comparison of Three Techniques of Nasogastric Tube Insertion Without Instrumentation
Condition: General Anesthesia
Study type: Interventional

Summary: 
      This study compares two modified techniques(contralateral cricothyroid pressure and
      ipsilateral head turning technique) of nasogastric tube insertion in anesthetized and
      intubated patients with the conventional technique.
    

Detailed description: 
      The insertion of nasogastric tube in anesthetized, paralysed and intubated unconscious
      patients may be difficult, with a reported failure rate of nearly 50% on the first attempt,
      with the head in neutral position there are many different maneuvers to facilitate the
      insertion of nasogastric tube published.

      Our hypothesis is that contralateral cricothyroid pressure to the selected nostril for
      nasogastric tube insertion will be able to avoid the difficulty.

      Therefore we are going to compare this technique with the conventional technique (head in
      neutral position) with lateral head turning group and contralateral cricothyroid pressure
      group We hope that the contralateral cricothyroid pressure will increase the success rate, as
      this will be helpful in intubated patients with neck pathology.
    

Intervention name(s): Conventional technique; Contralateral cricothyroid pressure; Ipsilateral head turning
Intervention type(s): Other; Other; Other
Intervention description(s): Nasogastric tube insertion with patient's head in neutral position; Cricothyroid pressure is applied externally in the contralateral direction of selected nostril before nasogastric insertion.; Patient's head is turned to the ipsilateral side of the selected nostril before nasogastric tube insertion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nasogastric tube; general anesthesia; head position
Docetaxel and Epirubicin With and Without G-CSF in Treating Women With Metastatic Breast Cancer
Condition: Breast Cancer; Neutropenia
MeSH terms: Breast Neoplasms; Neutropenia
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Colony-stimulating factors such as G-CSF may increase the number of
      immune cells found in bone marrow or peripheral blood and may help a person 's immune system
      recover from the side effects of chemotherapy.

      PURPOSE: Phase I/II trial to study the effectiveness of docetaxel and epirubicin with and
      without G-CSF in treating women with metastatic breast cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine the maximum tolerated dose and recommended phase II dose of
      docetaxel in combination with epirubicin and filgrastim (G-CSF) as first-line therapy in
      women with metastatic breast cancer (phase II closed as of 03/27/2000). II. Determine the
      pharmacokinetic profile of docetaxel and epirubicin in these patients. III. Evaluate the
      toxicity of this regimen given at the recommended phase II dose. IV. Determine the response
      rate and duration of response in patients treated with this regimen.

      OUTLINE: This is a multicenter, dose-escalation study of epirubicin and docetaxel. Patients
      receive epirubicin IV over 15 minutes followed by docetaxel IV over 60 minutes on day 1.
      Patients also receive filgrastim (G-CSF) subcutaneously on days 4-13. Treatment continues
      every 3 weeks for at least 6 courses in the absence of disease progression or unacceptable
      toxicity. Cohorts of 3-6 patients receive escalating doses of epirubicin and docetaxel until
      the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose in which at
      least 2 of 6 patients experience dose-limiting toxicity. Additional patients will be accrued
      to receive treatment at the recommended phase II dose (phase II closed as of 03/27/2000).
      Patients are followed at 1 month and then every 3 months for survival.

      PROJECTED ACCRUAL: Approximately 15-20 patients will be accrued within 4-5 months for the
      phase I portion of the study. A total of 15-30 patients will be accrued within 7-8 months for
      the phase II portion of the study (closed as of 03/27/2000).
    

Intervention name(s): filgrastim; docetaxel; epirubicin hydrochloride
Intervention type(s): Biological; Drug; Drug
Intervention MeSH terms: Docetaxel; Epirubicin
Primary purpose: Treatment
Keywords: stage IV breast cancer; recurrent breast cancer; neutropenia
Pregabalin and Radicular Pain Study (PARPS)
Condition: Cervical Spondylosis; Cervical Spondylotic Myelopathy; Cervical Spondylotic Radiculopathy
MeSH terms: Spondylosis; Radiculopathy; Spinal Cord Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to investigate the effectiveness of pregabalin (Lyrica) on nerve pain
      caused by degenerative neck problems. Pregabalin is a new drug registered for use in nerve
      pain worldwide
    

Detailed description: 
      The treatment of neuropathic pain is clinically challenging, and pain from cervical
      spondylosis (CS) is a common variant. This may result from degenerative spinal canal/cord
      stenosis (cervical spondylotic myelopathy (CSM)) or lateral recesses compromise, leading to
      nerve root compression (cervical spondylotic radiculopathy (CSR)).

      Pregabalin is a newly registered drug for the treatment of neuropathic pain. Its efficacy has
      been proven in randomised, placebo-controlled trials for post-herpetic neuralgia and diabetic
      neuropathy. However, its efficacy in CS with underlying CSR or CSM has not been established.
      Additionally, there are no data to date on its use in Asian patients.

      In this study, we prospectively evaluate its efficacy for treating neuropathic pain in
      degenerative CSR/ CSM 60 patients in an open-labelled, add on fashion. Self-evaluation and
      investigator rated scoring will be implemented.

      The results will be of value in the non-operative management of CS.
    

Intervention name(s): Pregabalin
Intervention type(s): Drug
Intervention description(s): At week 0, pregabalin 75mgbd will be given for 1 month. If visual analogue scale is not reduced by 50% after 1 month, pregabalin will be increased to 150mgbd for the second month
Other intervention name(s): Brand name: Lyrica
Intervention MeSH terms: Pregabalin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treatment of Chronic Hepatitis C During Pregnancy With Sofosbuvir/Velpatasvir
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      A single-arm, single-center, open label Phase 1 study of a 12-week course of Sofosbuvir
      (SOF)/Velpatasvir (VEL) in 10 HCV-infected pregnant women 1 that will evaluate the plasma
      pharmacokinetic parameters of SOF/VEL administered during pregnancy and compare them to those
      of a historical cohort of nonpregnant women.
    

Detailed description: 
      A single-arm, single-center, open label Phase 1 study of a 12-week course of SOF/VEL in 10
      HCV-infected pregnant women. Treatment will be initiated during the second trimester,
      reducing the risk of SOF/VEL exposure during organogenesis and ensuring treatment completion
      by delivery, minimizing the risk of perinatal transmission. The study will be completed in 10
      or 11 visits (7 maternal visits, delivery visit and 3 infant visits) which should align with
      prenatal and postpartum visits. Patients will be screened between 14+0 and 22+6 weeks of
      gestation confirmed by ultrasound by the time of their enrollment visit who are known to have
      chronic HCV infection. An HCV RNA level to confirm the patient is actively infected with HCV
      as well as an HCV genotype will be obtained. A full laboratory evaluation of liver function
      will be obtained to evaluate for renal failure and decompensated cirrhosis. A Hepatitis B
      Virus (HBV) panel will be performed to test all patients for evidence of current or prior HBV
      infection before initiation of HCV treatment. If the inclusion and exclusion criteria are
      met, the patient will be enrolled into the study between 23+0 and 25+6 weeks' gestation and
      initiated on a 12 week course of SOF/VEL. Systemic exposure of both VEL and SOF (SOF and
      inactive metabolite GS-331007) and intracellular SOF (GS-461203) will be assessed by
      pharmacokinetic sampling at 3, 6, and 9 weeks after first dose. HCV RNA viral load will be
      assessed at 12 weeks after completion of SOF/VEL treatment. Pregnancy and delivery outcomes
      will be collected prospectively. Neonatal outcomes will be assessed at birth, 8 weeks, 6
      months and 12 months. HCV RNA viral load will be obtained at birth (as available), 1 to 3
      months, at 6 months and then again at 12 months only if negative viral loads are not
      documented at 1 to 3 and 6 months. Neurodevelopmental assessments will be obtained at 6
      months and 12 months.
    

Intervention name(s): Sofosbuvir-Velpatasvir Drug Combination
Intervention type(s): Drug
Intervention description(s): One pill once a day for 12 weeks
Other intervention name(s): Epclusa
Intervention MeSH terms: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
Intervention model: Single Group Assignment
Intervention model description: Open-label, single arm
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pregnancy
Carotid Artery Stenting With Protection Registry
Condition: Carotid Artery Stenosis
MeSH terms: Carotid Stenosis; Constriction, Pathologic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate ischemic events and neuropsychological changes after
      carotid artery angioplasty and stenting with a neuroprotection device.
    

Detailed description: 
      Stroke is the third most common cause of death in North America with approximately 750,000
      new strokes reported annually, of which 150,000 are fatal. Approximately 75% of strokes occur
      in the distribution of the carotid arteries. Among those, a thrombotic etiology (carotid
      occlusive disease) is one of the most common causes. Recently published studies have shown
      that patients who underwent carotid stenting in combination with a cerebral protection device
      had better overall outcomes as related to stroke, death and MI as opposed to carotid
      endarterectomy. What is not known is whether protection devices which allow some particles
      (100 micron particle size or less) to pass through the filter or particles that embolize
      during placement or removal of the protection device, will have any delayed abnormal outcomes
      as determined by neuropsychological testing.
    

Intervention name(s): Carotid Stent with Distal Protection Device
Intervention type(s): Device
Intervention description(s): Carotid Stent Placement with Distal Protection
Other intervention name(s): Carotid Artery Stenting; Neurocognitive evaluation in Carotid Artery Stenting
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Carotid Artery stenting; Stroke
Effects of Expiratory Muscle Training on Cough Efficacy in Children and Adolescents With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      Cystic fibrosis (CF) is an autosomal recessive genetic disease characterized by recurrent
      airway infections, affecting many systems including lung, pancreas and sweat glands. Cough is
      an important defense mechanism for clearing the secretions that increase in respiratory
      diseases. There have been studies investigating the effect of expiratory muscle training on
      disease groups such as chronic obstructive pulmonary disease, multiple sclerosis, parkinson's
      disease, and the elderly and healthy individuals. Studies that evaluating effects of
      expiratory muscle training in cystic fibrosis are limited in the literature. The aim of this
      study was to evaluate the effect of cough strength in children and adolescents with CF and
      the effect of expiratory muscle training program on cough strength, exercise capacity,
      respiratory muscle strength and quality of life.
    


Intervention name(s): expiratory muscle training
Intervention type(s): Other
Intervention description(s): The intensity of training will been determined after assessment of maximal expiratory pressure (MEP). The first training session will perform under the supervision of a physiotherapist, patients will perform training at home. MEP measurement will reevaluate every two weeks and the intensity of training will set according to MEP levels.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: expiratory muscle training; cough; respiratory muscle strength; exercise capacity
Study to Compare Cardiovascular Side Effects of Teysuno Versus Capecitabine
Condition: Gastrointestinal Cancer; Cancer of Unknown Primary Site; Pancreatic Cancer; Bile Duct Neoplasms
MeSH terms: Gastrointestinal Neoplasms; Bile Duct Neoplasms; Neoplasms, Unknown Primary
Study type: Interventional
Phase: Phase 2

Summary: 
      Capecitabine is a chemotherapy drug used to treat many types of cancer including bowel and
      stomach cancer. Unfortunately a side effect of this drug is that it causes heart problems
      including heart attacks. An alternative drug, called teysuno is used extensively in other
      countries instead of capecitabine and appears to have less of a bad effect on the heart
      whilst still killing cancer cells. This study will investigate the effect of these two drugs
      on the heart and blood vessels and will be the first of its kind in humans.
    

Detailed description: 
      Fluoropyrimidines (FPs) are widely used chemotherapy agents for the management of patients
      with colorectal, breast, upper gastrointestinal, head and neck cancers. Capecitabine is an
      oral prodrug of 5-fluorouracil (5FU) which is used extensively in the UK but is associated
      with clinically overt cardiotoxicity in up to 9% of patients. Cardiotoxicity occurs more
      commonly in patients with cardiovascular disease and manifests as chest pain, myocardial
      infarction, congestive heart failure, or sudden death with a mortality as high as 30%. In a
      study of continuous ECG Holter monitoring in patients receiving 5FU infusion, the majority
      (68%) of patients had ischaemic ECG changes and 2 patients died suddenly. We conducted a
      national survey of UK oncologists and 60% felt that 5FU/capecitabine cardiotoxicity was a
      significant problem in their clinical practice.

      Hypotheses for this toxicity include ischaemia secondary to coronary artery spasm, direct
      endothelial cell toxicity, myocardial toxicity and interactions with the coagulation system.
      Studies implicate a catabolite of 5FU, in particular fluoro-alanine (FBAL). FBAL is further
      metabolized to fluoroacetate (FAC), a cardiac toxin that inhibits mitochondrial aconitase,
      resulting in cell death.

      Teysuno is an oral fluoropyrimidine that has recently obtained a European licence. It is a
      combination of tegafur (5-FU prodrug), gimeracil (dihydropyrimidine dehydrogenase (DPD)
      inhibitor) and oteracil (phosphorylation inhibitor). There have been no reports of cardiac
      toxicity with teysuno. The incorporation of a DPD inhibitor should reduce FBAL concentrations
      which may prevent FP cardiotoxicity. However, this remains to be established.
    

Intervention name(s): Teysuno; Capecitabine
Intervention type(s): Drug; Drug
Other intervention name(s): Tegafur / Gimeracil / Oteracil; Xeloda tablets
Intervention MeSH terms: Capecitabine; Tegafur
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety Study for Adolescents With Concussion
Condition: Brain Injury; Concussion
MeSH terms: Brain Injuries
Study type: Interventional

Summary: 
      The purpose of the study was to determine if administration of an exercise stress test within
      the first ten days after a sports related concussion would delay or otherwise interfere with
      recovery.
    

Detailed description: 
      The purpose of the study was to determine if administration of an exercise stress test within
      the first ten days after a sports related concussion would delay or otherwise interfere with
      recovery. All participants were adolescents injured while playing sports. All concussions
      were confirmed by an experienced sports medicine physician before random assignment of the
      participant to receive the treadmill test to determine exercise intolerance or not.

      Recovery was defined as (a) return to asymptomatic state; (b) ability to exercise to
      exhaustion without exacerbation of symptoms and (c) confirmation of recovery by a physician
      who is blinded to the assignment and to results of exercise testing. Symptoms were self
      reported on a daily basis using an online data record.

      Regardless of recovery rate all participants were assessed at two weeks following their first
      clinic visit. At the second visit all subjects, regardless of group assignment were assessed
      on ImPACT, and the treadmill based exercise stress test. Individuals who were not recovered
      by the second visit were followed until recovered no matter how long that took.

      Analysis of data examined recovery rates of the two groups of adolescents to determine
      whether use of a exercise stress test early after concussion caused any adverse events or
      interfered in any way with recovery.
    

Intervention name(s): Exercise stress test (BCTT)
Intervention type(s): Other
Intervention description(s): Participants are assessed for exercise tolerance using a treadmill with gradually increasing angle to increase workload. Stress test is stopped when there is symptom exacerbation or when participant experiences voluntary exhaustion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Efficacy Test on Skin Hydration and Skin Barrier Function
Condition: Dry Skin
Study type: Interventional

Summary: 
      The effects of topically applied pyridoxine tri-isopalmitate (P-IP) which stimulates
      filaggrin synthesis in keratinocytes, on skin hydration and barrier function were examined.
      Subjects were separated into two groups to examine the effect of P-IP. Subjects were treated
      with P-IP formulation on one side of the face and with a placebo formulation on the other
      side twice daily (morning and evening) for 28 days. All subjects gave written informed
      consent prior to the study. The skin hydration and TEWL (transepidermal water loss) were
      evaluated by measuring skin surface conductance with a skin hygrometer SKICON 200EX (I.B.S.
      ltd., Japan) and TEWL meter AS-CT1 (ASAHI BIOMED, Tokyo, Japan), respectively.
    

Detailed description: 
      It is expected that the long-term application of P-IP increase skin surface water contents
      and suppress TEWL.
    

Intervention name(s): Pyridoxine tri-isopalmitate
Intervention type(s): Other
Intervention description(s): 2% dosage, oil-in-water emulsion, twice a day, 28 days
Intervention MeSH terms: Pyridoxine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: dry skin condition