bioihbjkbjnl/mcl2 huggingface dataset:
Study Comparing Tigecycline vs. Levofloxacin in Subjects Hospitalized With Community-Acquired Pneumonia
Condition: Community-Acquired Infections; Bacterial Pneumonia; Cross Infection
MeSH terms: Infections; Communicable Diseases; Pneumonia; Pneumonia, Bacterial; Community-Acquired Infections; Cross Infection
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the efficacy and safety of IV tigecycline to IV levofloxacin in the treatment of
      subjects with CAP requiring hospitalization.
    


Intervention name(s): Tigecycline; Levofloxacin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Levofloxacin; Tigecycline
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: Bacterial Pneumonia
Citicoline Effects on Cortical Membrane Structure and Function
Condition: Healthy
Study type: Interventional

Summary: 
      The goal of this project is to determine the effects of 6-week dietary supplementation with
      one of two doses of citicoline (250 mg/d, 500 mg/d) or placebo on prefrontal cortical
      membrane dynamics (31P-MRS) and event-related functional activation (fMRI) in healthy
      middle-aged adults.
    

Detailed description: 
      To determine the effect of citicoline supplementation on cortical structure and function in
      healthy middle-aged adults. Test 1: The effect of citicoline (500 mg/d) compared with placebo
      on event-related anterior cingulate cortex (ACC) activation during sustained attention by
      fMRI. Test 2: The effect of citicoline (500 mg/d) compared with placebo on reaction time and
      increasing accuracy on the sustained attention task (CPT-IP). Test 3: The effect of
      citicoline compared with placebo on phosphodiester (PDE) and b-NTP levels in the ACC by
      31P-MRS. Test 4: ACC activation and CPT-IP performance (fMRI) and ACC PDE levels (31P-MRS)
      following high-dose citicoline (500 mg/d) compared with placebo at Week 3. Test 5: The effect
      of low-dose citicoline (250 mg/d) compared with placebo on an ACC activation and CPT-IP
      performance (fMRI) and ACC PDE levels (31P-MRS). Test 6: Among all subjects (n=60), the
      relationship between baseline red blood cell (RBC) omega-3 fatty acid (EPA+DHA) levels and
      ACC activation, ACC PDE levels, or the effects of citicoline.
    

Intervention name(s): Citicoline supplement; Placebo supplement
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Cellulose
Other intervention name(s): Cognizin; Placebo
Intervention MeSH terms: Cytidine Diphosphate Choline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Assessment of a New Goldmann Applanation Tonometer
Condition: Intraocular Pressure
Study type: Interventional
Phase: Phase 3

Summary: 
      The classic Goldmann applanation tonometer has been further developed. The applanation
      principle has been retained, while the internal force transmission and the pressure gauging
      have been optimized, and the display of results digitized.

      The purpose of the study is to compare the standard Goldmann applanation tonometer AT900 with
      the new version of the device, and to test the reliability and reproducibility of
      measurements, as well as its safety.
    

Detailed description: 
      The classic Goldmann applanation tonometer has been further developed. The applanation
      principle has been retained, while the internal force transmission and the pressure gauging
      have been optimized, and the display of results digitized.

      The purpose of the study is to compare the standard Goldmann applanation tonometer AT900 with
      the new version of the device, and to test the reliability and reproducibility of
      measurements, as well as its safety.

      Patients at the Department of Ophthalmology, University of Bern, will be included after
      informed consent. The study has been approved by the local ethical committee. Routine
      ophthalmologic examination will be performed and inclusion criteria evaluated. Measurements
      will be taken with the two tonometers in random order. Prior to pressure measurement, central
      corneal thickness will be measured with a non-contact method (Optical Low Coherence
      Reflectometry, OLCR pachymeter, Haag-Streit, Koeniz, Switzerland).
    

Intervention name(s): Tonometry
Intervention type(s): Device
Intervention description(s): Tonometry : measurement of intraocular pressure with an applanation tonometer
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Intraocular pressure; Goldmann tonometry; applanation tonometry; Tonometry, Ocular
Effects of Neck Stabilization Exercise With Heat Therapies
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      In this study, we aimed to determine the effects of heat therapies and neck stabilization
      exercises on pain, disability, range of motion, and mood of NP patients.
    

Detailed description: 
      Chronic non-specific neck pain (NP) has become one of the main causes of disability in the
      adult population around the world.Several treatment options used like; exercise, manual
      therapy, electrotherapy, and hot treatments etc. In this study, we aimed to determine the
      effects of heat therapies and neck stabilization exercises on pain, disability, range of
      motion, and mood of NP patients.100 patients with NP will be included.Patients will be
      randomyl assigned to 4 groups and will receive a total of 3 weeks of treatment. Patients'
      pain levels (visual analogoue scale VAS), quality of life (short form 36), mood (Beck
      deppression inventory BDI), range of motion, and neck disability index were evaluated prior
      to treatment, at 6th and at 12th weeks.
    

Intervention name(s): neck stabilization exercise (nse); NSE + HOT PACK THERAPY; NSE + infrared therapy; NSE + ultrasound therapy
Intervention type(s): Other; Other; Other; Other
Intervention description(s): neck stabilization exercise (nse)- exercise; NSE + HOT PACK THERAPY- exercise plus heat therapy; NSE + infrared therapy- exercise plus heat therapy; NSE + ultrasound therapy exercise plus heat therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: hot pack; exercise; ultrasound therapy
Pharmacokinetic Study of Oral Gepotidacin (GSK2140944) in Subjects With Uncomplicated Urinary Tract Infection (Acute Cystitis)
Condition: Infections, Bacterial
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Bacterial Infections; Cystitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Gepotidacin (GSK2140944) is a novel triazaacenaphthylene bacterial type II topoisomerase
      inhibitor that is being developed for the treatment of uncomplicated urinary tract infections
      (UTIs; acute cystitis). This Phase IIa study will evaluate plasma and urine pharmacokinetics
      of gepotidacin in female subjects with acute cystitis. Eligible female subjects will receive
      twice daily (BID) dose of gepotidacin 1500 milligram (mg) for 5 days via oral route.
      Pre-treatment and post-treatment samples for pharmacokinetic (PK) assessments will be
      collected throughout the study. The total duration of the study is approximately 28 days.
    


Intervention name(s): Gepotidacin
Intervention type(s): Drug
Intervention description(s): Gepotidacin tablets will be available at a dose strength of 750 mg. Tablets will be administered BID with water after consumption of food.
Intervention MeSH terms: Gepotidacin
Intervention model: Single Group Assignment
Intervention model description: Subjects will receive 1500 mg gepotidacin tablets BID via oral route for 5 days.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gepotidacin; GSK2140944; acute cystitis; pharmacokinetics; urinary tract infections
One vs. Three Hyperbaric Oxygen Treatments for Acute Carbon Monoxide Poisoning
Condition: Carbon Monoxide Poisoning
MeSH terms: Poisoning; Carbon Monoxide Poisoning
Study type: Interventional
Phase: Phase 4

Summary: 
      This randomized trial will investigate important clinical outcomes of patients with acute
      carbon monoxide poisoning randomized to receive either one or three hyperbaric oxygen
      treatments.
    

Detailed description: 
      All patients presenting with acute carbon monoxide poisoning will receive one hyperbaric
      oxygen treatment (barring contraindications for hyperbaric oxygen therapy). After this
      treatment, eligible patients who provide consent will be randomly allocated to receive two
      sham sessions, or two additional hyperbaric oxygen sessions administered in a double-blind
      fashion.

      Outcome measures will be administered at 6 weeks and 6 months.
    

Intervention name(s): Hyperbaric Oxygen (HBO2) - 3 sessions; Hyperbaric Oxygen (HBO2) - 1 session
Intervention type(s): Combination Product; Combination Product
Intervention description(s): Before patients are offered an opportunity to participate in this study, they will receive a single hyperbaric oxygen session. During the first session, hyperbaric oxygen will be administered at 3.0 atmospheres absolute (atm abs) for 25 minutes breathing oxygen, 5 minutes air breathing, 25 minutes oxygen breathing, 5 minutes air breathing, pressure reduced to 2.0 atm abs for 30 minutes breathing oxygen, 5 minutes air breathing, and 30 minutes oxygen breathing.
For the second and third hyperbaric oxygen sessions, the subject will breathe 100% oxygen delivered at 2 atm abs for 90 minutes with two 5-minute air breathing periods.; During the first session, hyperbaric oxygen will be administered at 3.0 atmospheres absolute (atm abs) for 25 minutes breathing oxygen, 5 minutes air breathing, 25 minutes oxygen breathing, 5 minutes air breathing, pressure reduced to 2.0 atm abs for 30 minutes breathing oxygen, 5 minutes air breathing, and 30 minutes oxygen breathing.
The second and third chamber sessions are sham sessions: room air delivered at 1.0 atmospheres absolute for 90 minutes with two sham 5-minute air breathing periods.
Other intervention name(s): Hyperbaric Oxygen; HBO2; HBO; HBOT; HBO2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Carbon monoxide poisoning; Hyperbaric oxygen therapy; Randomized controlled trial; Clinical investigation
The ACTonHEART Study: Design of a Randomized Controlled Clinical Trial of Acceptance and Commitment Therapy for Cardiac Patients
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The study will determine whether a brief intervention program based on Acceptance and
      Commitment Therapy can be effective for the reduction of modifiable risk factors and
      improvement of psychological well-being in patients referred to cardiac rehabilitation
    

Detailed description: 
      The Acceptance and Commitment Therapy is a mindfulness-based intervention which efficacy has
      been proven in the treatment of depression and anxiety, in stress reduction and in the
      modification of health- related behaviors in patients with several physical conditions. The
      application of an acceptance-based program in cardiac patients has revealed high treatment
      satisfaction and initial evidences of effectiveness in increasing heart-healthy behaviour.

      The purpose of the trial is to evaluate the efficacy of a brief group-administered program
      based on Acceptance and Commitment Therapy in improving patients' ability to address
      modifiable multiple cardiovascular risk factors and overall psychological well-being,
      compared with the usual care.
    

Intervention name(s): ACT-based intervention; usual care
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acceptance and Commitment Therapy; Cardiac rehabilitation
Plus Deep Water Running on Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Objectives: To evaluate the effect size on non-specific chronic low back pain (CLBP) of
      evidence-based physiotherapy (EBP) with and without the addition of deep water running (DWR)
      on pain, physical disability and general health state.

      Materials and methods: Randomized, double-blind, controlled trial (therapists and assessors)
      involving 46 persons with CLBP over 15 weeks with two interventions, presented three times a
      week. Each group received EBP (personalized exercise program, manual therapy and health
      education) while one group performed supplementary 20 min sessions of DWR at the
      individualized aerobic threshold. Measurements were made pre and post intervention for pain,
      disability and general health. Range of motion of lumbar spine in the sagittal plane, maximum
      isometric strength and muscle endurance of lumbar and hip extensors was assessment.
    


Intervention name(s): GP in Physio; GP in Physio plus DWR
Intervention type(s): Procedure; Procedure
Intervention description(s): manual therapy, educational advice of health promotion and physical exercises therapy based in a individual assessment; GP in Physio plus a supplementation of DWR training in high intensive aerobic threshold
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: head out water immersion,; high intensity exercise,; evidence-based physiotherapy;; aquatics;; hydrotherapy; aquatics therapy; exercise therapy
Reducing Clinical Inertia in Hypertension Treatment: A Pragmatic Trial
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The goal of this project is to use health information technology and team-based care in novel
      ways to support the establishment of a Patient-Centered Medical Home model of care aimed at
      improving the diagnosis and management of hypertension. Compared with patients who receive
      usual care, patients who receive intervention will have a lower average systolic blood
      pressure 9 months after randomization.
    


Intervention name(s): Active Outreach to Patients and Providers
Intervention type(s): Other
Intervention description(s): An outreach coordinator raised patient and provider awareness of unmet Blood Pressure goals, arranged Blood Pressure-focused clinic visits, and furnished providers with treatment decision support.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: hypertension; blood pressure; primary care; patient centered medical home; health information technology; clinical inertia
BAY81-8973 Pediatric Safety and Efficacy Trial
Condition: Haemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective was to evaluate the safety and efficacy of the treatment with
      BAY81-8973 for prophylaxis and treatment of breakthrough bleeds in children with severe
      hemophilia A.

      The secondary objectives were

        -  To assess the safety and efficacy of BAY81-8973 during surgeries.

        -  To assess incremental recovery of BAY81-8973.

        -  To assess pharmacokinetic (PK) parameters in a subset of children (Previously treated
           patients [PTPs] and previously untreated patients [PUPs] / minimally treated patients
           [MTPs] - participation in PK sampling was voluntary and required consent).
    


Intervention name(s): Recombinant Factor VIII (Kovaltry, BAY81-8973); Recombinant Factor VIII (Kovaltry, BAY81-8973)
Intervention type(s): Biological; Biological
Intervention description(s): Main study: 25-50 IU/kg at least 2x/week for 6 months and at least 50 EDs, IV infusion; Extension study: 25-50 IU/kg at least 2x/week for at least 100 cumulative EDs (main study - Part A and extension study), IV infusion. Exposure day (ED): An ED is a unit of time (1 day) in which replacement treatment of Hemophilia is given to a patient.; Main study: 15-50 IU/kg at least 1x/week for at least 50 EDs or until inhibitor development, IV infusion; Extension study: For participants having reached at least 50 EDs in main study - Part B: 25-50 IU/kg at least 2x/week for at least 100 cumulative EDs (main study - Part B and extension study), IV infusion. For participants who developed an inhibitor in main study - Part B: up to 200 IU/kg per day or 100 IU/kg twice a day at the discretion of the investigator and coordinating investigator until successful eradication of the inhibitor, or until failure, for up to18 months (treatment beyond 18 months required an agreement with the sponsor and coordinating investigator), IV infusion
Intervention MeSH terms: Factor VIII
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Recombinant factor VIII; Pediatric use
Study Evaluating the Bioavailability of Naproxen 500 mg in Three Formulations
Condition: Arthritis
MeSH terms: Arthritis
Study type: Interventional
Phase: Phase 1

Summary: 
      We will evaluate the bioavailability of naproxen 500 mg administered as three dfferent
      formulations.
    


Intervention name(s): PN400; naproxen; naproxen
Intervention type(s): Drug; Drug; Drug
Intervention description(s): naproxen 500 mg /esomeprazole 20 mg; naproxen 500 mg tablet; naproxen 500 mg
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Comparison of Endoscopic Injection of Conventional and Double Doses Cyanoacrylate for Gastric Variceal Hemorrhage
Condition: Gastric Variceal Bleeding
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      The recent practice guideline recommends endoscopic injection of cyanoacrylate (GVO) is the
      preferred method to treat acute gastric variceal bleeding. The rebleeding rate remains high
      following GVO.We hypothesized that a double-dose of cyanoacrylate may obliterate the varices
      more effectively and achieve better hemostasis.
    

Detailed description: 
      Although outcome of variceal hemorrhage has been improved in the last two decades, variceal
      hemorrhage is still the most serious complication of portal hypertension and chronic liver
      disease. Occurrence of gastric varices (GV) rupture is less often than esophageal varices
      (EV) but it is characteristic of higher rebleeding rate and mortality and represents an even
      tougher problem than EV hemorrhage. Facing these challenges, there is no consensus on the
      best treatment of GV hemorrhage and therefore it is mainly empirical. Endoscopic treatment is
      an alternative in the management of GVH. Injection sclerotherapy has been applied to arrest
      GV hemorrhage but it is associated with a high rebleeding rate (50~90%) and thus is regarded
      as only a temporary hemostatic measure. The advantage of endoscopic variceal ligation for EV
      hemorrhage has been documented, however, endoscopic variceal ligation for GVH is not as
      promising because of its high rebleeding rate around 50%. Endoscopic injection of
      N-butyl-2-cyanoacrylate, a so-called "tissue glue", was more effective for GV hemorrhage than
      other sclerosants and endoscopic ligation, however, its rebleeding rate is still high around
      30~50%. The theoretical advantages of tissue glue derives from its unique ability to plug the
      varix lumen immediately. Each injection of tissue glue in conventional use was usually
      prepared by a mixture of 0.5 ml cyanoacrylate and 0.5 ml Lipiodol. Therefore, we hypothesized
      that double dose cyanoacrylate (1 ml cyanoacrylate mixed with 1 ml Lipiodal) may obliterate
      the varices in further distance and broader area and that may achieve more effective
      hemostatic results than conventional dose. Therefore we designed a randomized trial to test
      the hypothesis.
    

Intervention name(s): Cyanoacrylate; Cyanoacrylate
Intervention type(s): Procedure; Procedure
Intervention description(s): Cyanoacrylate 0.5 ml, endoscopic injection of gastric varix at each shot; Cyanoacrylate 1 ml, endoscopic injection for gastric varices at each shot
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gastric variceal bleeding; cyanoacrylate; rebleeding; complication; survival; acute gastric variceal bleeding
A Study to Evaluate the Safety and Efficacy of Tazarotene Foam, 0.1%, in Subjects With Common Facial Acne - W0260-301
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess safety and efficacy of a new foam formulation of
      tazarotene in subjects with acne vulgaris.
    

Detailed description: 
      A multicenter, randomized, double-blind, vehicle-controlled, parallel-group study comparing
      tazarotene foam with vehicle foam in subjects with acne vulgaris. Approximately 742 subjects
      will be enrolled and randomized to 1 of the 2 study product groups in a 1:1 ratio (tazarotene
      foam: vehicle foam). Subjects will apply tazarotene foam or vehicle foam to the entire face
      once daily for 12 weeks; study visits will occur at baseline (week 0/day 1) and at weeks 2,
      4, 8, and 12.
    

Intervention name(s): Tazarotene foam; Vehicle Foam
Intervention type(s): Drug; Drug
Intervention description(s): Tazarotene foam once a day application to the face; Vehicle Foam once a day application to the face
Intervention MeSH terms: Tazarotene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ance
A Study to Investigate the Absorption, Metabolism and Excretion of [14C]-BGB-11417
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this study is to determine the mass balance, routes of elimination, and
      pharmacokinetics of [14C]-BGB-11417 in healthy male participants along with determining the
      concentrations of radioactivity in plasma, fecal and urinary elimination of total
      radioactivity.
    


Intervention name(s): [14C]-BGB-11417
Intervention type(s): Drug
Intervention description(s): A single oral dose of liquid formulation
Other intervention name(s): Sonrotoclax
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other