bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of a New Supraglottic Airway With Built-in Cuff Pressure Indicator
Condition: The Study Focuses on the Effect of a New Supraglottic Airway With Built-in Cuff Pressure Indicator on Postoperative Pharyngolaryngeal Adverse Events
Study type: Interventional

Summary: 
      The study compares the incidence of pharyngolaryngeal complications in patients managed with
      either a pressure-limiting strategy using the AES Ultra CPVTM or a standard practice using a
      LMA, in ambulatory surgery patients.
    

Detailed description: 
      Recent evidence suggests that reduction of LMA intracuff pressure may decrease the incidence
      of pharyngolaryngeal symptoms. Yet, pressure manometers are not widely available limiting the
      application of a strategy of intracuff pressure reduction. The Ultra airway has been designed
      to provide continuous indication of intracuff pressure and can limit the intracuff pressure
      to < 60 cm H2O. This study compares the incidence of pharyngolaryngeal complications in
      patients managed with either a pressure-limiting strategy using the Ultra or a standard
      practice using a LMA, in ambulatory surgery patients.
    

Intervention name(s): LMA; Ultra
Intervention type(s): Device; Device
Intervention description(s): Ultra
Other intervention name(s): The laryngeal mask airway-Classic; AES Ultra CPVTM LMA (Ultra)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Keywords: Airway Cuff; LMA; Ultra; Cuff Pressure; Ventilation; Anesthesia; Intubation
Effects Of Muscle Energy Technique Versus Mobilization
Condition: Sacroiliac Joint Dysfunction
MeSH terms: Joint Diseases
Study type: Interventional

Summary: 
      The aim is to describe the severity of pain in postpartum female and management of sacroiliac
      joint pain and disability and define the effects of manual therapy on sacroiliac joint
      dysfunction and pain
    

Detailed description: 
      The aim is to describe the severity of pain in postpartum female and management of sacroiliac
      joint pain and disability and define the effects of manual therapy on sacroiliac joint
      dysfunction and pain in postpartum females and to check whether the amount of gaining range
      of movement is similar among postpartum female undergoing with mobilization therapy and with
      muscle energy technique.
    

Intervention name(s): mobilization technique; muscle energy technique
Intervention type(s): Other; Other
Intervention description(s): Mobilization of sacroiliac joint which will increase the range of motion and reduction in pain and improvement in functional limitation.; Muscle energy technique it is known as active muscular relaxation technique. It helps in lengthening the shorten muscle and increasing range of restricted muscles
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Mobilization; Muscle energy technique; Postpartum; Sacroiliac joint pain
A Study of ALKS 9072 in Subjects With Chronic Stable Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will determine the pharmacokinetics (PK), safety, and tolerability of ALKS 9072
      (also known as ALKS 9070) after 4 monthly doses in adults with chronic stable schizophrenia.
    

Detailed description: 
      Three active treatment groups and a placebo group are planned. Randomization will be
      sequential by dose level across the sites with placebo assignments randomly inserted. Each
      subject's participation will be approximately 8 months, including screening, treatment
      period, and a 3-month follow-up period.
    

Intervention name(s): ALKS 9072, Low dose; ALKS 9072, Med dose; ALKS 9072, High dose; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): IM injection, given monthly; IM injection, given monthly; IM injection, given monthly; Dosed matched placebo IM injection, given monthly
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Long Term Outcome After Serial Lidocaine Infusion in Peripheral Neuropathic Pain
Condition: Peripheral Neuropathy
MeSH terms: Neuralgia; Peripheral Nervous System Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study to evaluated Long term outcome after serial Lidocaine infusion when
      compared with placebo in peripheral neuropathic pain patients in acute stage (less than 6
      months) at 3 months after first time of infusion
    

Detailed description: 
      Peripheral nerve injury may give rise to severe and long-lasting types of pains which are
      often resistant to treatment such as opioid, tricyclic antidepressant or anticonvulsant.
      Lidocaine infusion has been the one of intractable neuropathic pain treatment . My hypothesis
      the serial lidocaine infusion can adequate pain control and can prevent chronic pain (central
      sensitisation). Therefore, we designed this prospective, randomised, double-blind, controlled
      study to evaluate the efficacy of serial lidocaine infusion in peripheral neuropathic pain
      compared with placebo in long term outcome (at 3 month).
    

Intervention name(s): Lidocaine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Lidocaine 3 mg/kg dilute in Normal Saline to 50 ml intravenous infusion in 1 hour
Other intervention name(s): Intravenous lidocaine
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Peripheral neuropathy
Efficacy of Closed-loop Ventilation to Reduced Sleep Disorders
Condition: Acute Mechanical Ventilatory Failure; Psychosis Associated With Intensive Care
MeSH terms: Hypoventilation; Sleep Wake Disorders; Parasomnias
Study type: Interventional

Summary: 
      Sleep's deficiencies are very common in intensive care. Mechanical ventilation is a known
      factor in this deterioration.The investigators hypothesize that close-loop ventilation mode
      (Intellivent-ASV) is able to minimize sleep deterioration, adjusting ventilation to the
      patient needs.
    

Detailed description: 
      In intensive care, conventional mechanical ventilation (pressure support) generates apneas
      and asynchronies during sleep. Intellivent-ASV would be able to avoid apneas, providing
      controlled cycles when respiratory rate become too low. Moreover, the constant adjustment of
      ventilatory parameters to the patient needs would avoid asynchronies between the ventilator
      and the patient ventilatory drive.
    

Intervention name(s): Intellivent-ASV; Conventional ventilation
Intervention type(s): Device; Device
Intervention description(s): 12 hours of mechanical ventilation with intellivent-ASV; 12 hours of mechanical ventilation with pressure support ventilation
Other intervention name(s): closed-loop ventilation; pressure support ventilation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: sleep; intensive care; mechanical ventilation
Safety and Efficacy of YPEG-rhG-CSF in Cancer Patients Receiving Chemotherapy
Condition: Non Small Cell Lung Cancer; Breast Cancer
MeSH terms: Neutropenia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to examine which dose of YPEG-rhG-CSF, once-per-cycle, has similar efficacy and
      safety, comparing to PEG-rhG-CSF, once-per-cycle, in chemotherapy-induced neutropenia
    


Intervention name(s): YPEG-rhG-CSF, 20μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle; YPEG-rhG-CSF, 30μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle; YPEG-rhG-CSF, 45μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle; PEG-rhG-CSF, 100μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle
Intervention type(s): Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neutropenia; Febrile neutropenia; PEG-rhG-CSF; Myelosuppressive chemotherapy
Optimization of the Dosage Regimen of Growth Hormone Therapy in Children Born Small for Gestational Age
Condition: Small Gestational Age (SGA)
Study type: Interventional
Phase: Phase 3

Summary: 
      Multicentric, open-label, randomized, pilot comparative study in parallel groups comparing 1
      group of subjects receiving 0.057 milligram/kilogram/day (mg/kg/day) or 0.40 mg/kg/week of
      Saizen® during 1 year to 1 group receiving 0.035 mg/kg/day (0.24 mg/kg/week) of Saizen®
      during 1 year after an initial 3-year treatment of recombinant human growth hormone (r-hGH)
      therapy with 0.057 mg/kg/day in both groups.
    


Intervention name(s): Saizen®; Saizen®
Intervention type(s): Drug; Drug
Intervention description(s): Saizen® [somatropin (recombinant deoxyribonucleic acid [rDNA] origin) for injection], a r-hGH, is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone.; Saizen® [somatropin (rDNA origin) for injection], a r-hGH, is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone.
Other intervention name(s): somatropin; somatropin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Regaining Bladder Control in Postmenopausal Women With Osteoporosis
Condition: Urinary Incontinence
MeSH terms: Osteoporosis; Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      Conservative management for urinary incontinence has been shown to improve bladder control.
      We are conducting a study of the effectiveness of conservative management for urinary
      incontinence in women who also have osteoporosis. We hope to find that treatment for
      incontinence improves bladder control and thereby allows women to be more active and reduces
      their risk of falling and breaking bones.
    


Intervention name(s): Physiotherapy for urinary incontinence
Intervention type(s): Behavioral
Intervention description(s): See Detailed Description.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Randomized clinical trial; osteoporosis; urinary incontinence; physiotherapy; education
Immunogenicity and Safety Study of a Rapid Immunization Schedule With FSME-IMMUN 0.5 mL in Healthy Adults Aged 16 - 65 Years
Condition: Encephalitis, Tick-borne
MeSH terms: Encephalitis, Tick-Borne; Encephalitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to establish the earliest time point at which vaccines are
      expected to show seropositive antibody levels after vaccination with FSME-IMMUN 0.5 mL using
      a rapid immunization schedule (2 vaccinations administered 12 +/- 2 days apart.
    


Intervention name(s): Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Tick-Borne Encephalitis
The Effects of Minocycline in Humans
Condition: Memory Impairment
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine minocycline's effects on cognitive performance and measures of mood in abstinent
      cocaine users. Minocycline is a tetracycline derivative antibiotic that also inhibits
      microglia activation and the release of pro-inflammatory cytokines, chemokines, and nitric
      oxide (NO) production. Previous animal and human studies suggest that minocycline may have
      utility as a treatment for cocaine addiction.
    

Detailed description: 
      We are proposing a randomized, double-blind, crossover study. A total of 40 male and or
      female subject completers will have two 4-day treatment periods, in which they will be
      randomized to minocycline (200 mg/day) or placebo. During the first 3 days of each treatment
      period, subjects will have daily clinic visits for medication administration and monitoring
      of adverse events. On Day 4, subjects will have an experimental session in which measures of
      mood and cognitive performance will be obtained. Following a washout period, ranging from 5
      to 15 days, subjects will be crossed over to the alternative treatment.

      This study began July 2013; currently 7 subjects were randomized with 5 completers and two
      drop outs. This study is in data analysis phase.
    

Intervention name(s): Sugar pill; Minocycline
Intervention type(s): Drug; Drug
Intervention description(s): you will receive 0.0 mg as a single daily dose for 4 days; you will receive 200 mg as a single daily dose for 4 days
Other intervention name(s): sugar pill, placebo; tetracycline antibiotic
Intervention MeSH terms: Anti-Bacterial Agents; Minocycline; Tetracycline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: Abstinent cocaine users; minocycline; antibiotic
Lab Study of MQX-503 in Treatment of Raynaud's
Condition: Raynaud Disease; Raynaud Disease Secondary to Scleroderma; Raynaud Secondary to Other Autoimmune Disease
MeSH terms: Neoplasm Metastasis; Raynaud Disease; Autoimmune Diseases
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine, in comparison to a placebo control, the response
      to two dosage strengths of a topical gel formulation of nitroglycerin, MQX-303, in the
      determination of finger blood flow and skin temperature in the fingers of patients with
      moderate to severe Raynaud's phenomenon, follwoing exposure to cold temperatures.

      Blood flow is determined by scanning laser Doppler equipment and skin temperature is measured
      using attached thermistor probes. Following baseline measurements, the study gel is applied,
      the hand is placed in a cold chamber, and then blood flow and skin temperature are monitored
      for the next two hours.

      Each patient will receive multiple doses on different days so that each can serve as his/her
      own control in interpreting the response.
    


Intervention name(s): topical organogel with nitroglycerin
Intervention type(s): Drug
Intervention MeSH terms: Nitroglycerin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Raynaud's; sclerderma; systemic sclerosis; autoimmune disease
Local IgE in Subjects With Allergic or Non-allergic Rhinitis
Condition: Perennial Rhinitis
MeSH terms: Rhinitis; Common Cold
Study type: Interventional

Summary: 
      The purpose of the study is to investigate the incidence of non-allergic rhinitis on a not
      selected group of young students (n=100-300). Students will be selected by public posting. In
      all students an allergy skin test will be performed. Then the local IgE of 24 subjects with
      non-allergic rhinitis will be compared to the local IgE of 24 subjects with allergic rhinitis
      and positive prick test to house dust mite. In addition 20 controlls will be investigated.
      Based on these investigations, the importance of local IgE and the IgE spectrum in
      conjunction with rhinitis should be further clarified.
    

Detailed description: 
      20% of Germans suffer from seasonal or all-season rhinitis. Despite typical allergic
      symptoms, in a part of the affected patients (about 10-20%) an allergy cannot be found on
      skin prick test or blood. Therefore, the planned trial will investigate the incidence of
      allergic and non-allergic rhinitis in a non selected group of young students (n=100-300). The
      hypothesis postulates that in test subjects with non-allergic rhinitis the allergy can only
      be proven locally in nasal secretion.

      From the initial large cohort of patients, 24 subjects with house dust mite allergy and
      allergic rhinitis and 24 patients with non-allergic rhinitis will be selected and
      investigated in more detail at a second visit. At the second visit, blood and nasal secretion
      (measurement of local IgE) will be taken from all pre-selected 48 patients. At visit 2 a
      nasal provocation test with house dust mite allergen will be performed in all patients to
      compare nasal symptoms with the results of local IgE between patient groups. In addition the
      same investigations will be performed in a group of 20 healthy non-allergic subjects.
    

Intervention name(s): Observation
Intervention type(s): Other
Intervention description(s): Visit 1:
Physical examination (inspection of nasopharynx, auscultation of heart and lungs)
Completion of a Health Questionnaire
Lung function testing with spirometry
Skin prick test
Visit 2:
Physical examination (inspection of nasopharynx, auscultation of heart and lungs)
Measurement of nitric oxide in expired air (FeNO)
Taking nasal secretion samples with a cotton carrier for 15 min
Nasal provocation test with dust mite
Blood sample collection to define blood count, IgE and specific IgE
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Local IgE; Non-allergic rhinitis; Allergic rhinitis to house dust mite
Silver Doped Ceramic Coated Orthopedic Implants
Condition: Implant Site Infection; Implant Infection
MeSH terms: Infections; Communicable Diseases
Study type: Interventional

Summary: 
      In this study, CE (European Conformity) marked, domestic manufactured standard orthopedic
      implants will be used after silver HA coating with electrospray method in 30 patients
      requiring hip joint prostheses, intramedullary nails or external fixator in 30 patients to
      antimicrobial effectiveness. These patients will be tasted for liver and kidney functions and
      blood and urine silver levels in addition to routine tests such as full blood, complete
      biochemistry, C-reactive protein, erythrocyte sedimentation rate required in the normal
      diagnosis and treatment processes,
    

Detailed description: 
      In this study, considering the differences in bone contact surface area and interactions; hip
      joint prostheses, intramedullary nails and external fixator implants to be used in 30
      patients . CE (European Conformity) marked, domestic manufactured standard orthopedic
      implants will be used in patients after silver HA coating with electrospray method. These
      patients will be tasted for the evaluation of liver and kidney functions and blood and urine
      silver levels in addition to routine tests such as full blood, complete biochemistry,
      C-reactive protein, erythrocyte sedimentation rate required in the normal diagnosis and
      treatment processes, and will be monitored for at least 12 months. The performance of coating
      to be applied and any unwanted side effects in normal conditions of use will be evaluated..
    

Intervention name(s): Silver doped hydroxyapatite coated implants
Intervention type(s): Device
Intervention description(s): In this study, CE marked, domestic manufactured standard orthopedic implants will be used in 30 patients after silver ceramic coating with electrospray method. These patients will be tasted for the evaluation of liver and kidney functions and blood and urine silver levels in addition to routine tests such as full blood, complete biochemistry, C-reactive protein, erythrocyte sedimentation rate required in the normal diagnosis and treatment processes, and will be monitored for at least 12 months.
Intervention model: Single Group Assignment
Intervention model description: In this study, hip joint prostheses, intramedullary nails and external fixator implants to be used in 30 patients . CE marked, domestic manufactured standard orthopedic implants will be used in patients after silver doped HA coating . Antimicrobial effectiveness of the coating will be evaluated. These patients will be tasted for the evaluation of liver and kidney functions and blood and urine silver levels in addition to routine tests such as full blood, complete biochemistry, C-reactive protein, erythrocyte sedimentation rate required in the normal diagnosis and treatment processes, and will be monitored for at least 12 months.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Silver Hydroxiapatite Coating; Antimicrobial; Medical Device
Investigation of Analgesic and Anti-hyperalgesic Effect of Opioids in Experimental Pain
Condition: Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the analgesic and anti-hyperalgesic effect of Buprenorphine and Fentanyl against
      experimental pain in skin, muscle and bone. The study will be performed with healthy
      volunteers.
    


Intervention name(s): Buprenorphine; Fentanyl; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Buprenorphine: 20microg/h; Fentanyl: 25microg/h; Placebo: '5microg/h' (not active drug, it is just called '5microg/h')
Other intervention name(s): Norspan; Durogesic; Norspan
Intervention MeSH terms: Fentanyl; Buprenorphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: Buprenorphine; Fentanyl; Analgesic effect; Anti-hyperalgesic effect; Experimental pain
Use of Botox to Treat Scrotal Pain
Condition: Scrotal Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      There are no previous reports on the use of Onabotulinum Toxin A to treat men with scrotal
      pain that we found published. We propose a pilot study to use Botox to block the testicular
      nerves on a group of 15 men with chronic scrotal pain who have failed the standard medical
      therapy. The men must have had temporary relief from a testicular cord block using marcaine.
      Before and 1 month, 3 months and 6 months after the Onabotulinum Toxin A injection, the men
      would be asked to fill in visual analog scales for pain, a quality of life assessment, a
      depression index (MDI) and Chronic Epididymitis Symptom Index (CESI). They will also be
      subject to sensory testing of the scrotum before, after 1 month, 3 moths and 6 months.
    


Intervention name(s): Botox
Intervention type(s): Drug
Other intervention name(s): Onabotulinum Toxin A
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Scrotal pain; Botox