bioihbjkbjnl/mcl2 huggingface dataset:
Dornase Alfa Therapy for Ventilator Associated Lung Infections in the Neonatal Intensive Care Unit (NICU)
Condition: Pulmonary Infections
MeSH terms: Infections; Communicable Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the effect of Dornase alfa on preterm and late preterm neonates with ventilator
      associated pulmonary infections. Dornase alfa has been effective in the treatment of
      pulmonary infections in patients with cystic fibrosis by aiding mucus clearance. The bacteria
      causing pulmonary infections in cystic fibrosis patients is similar to those infecting
      preterm infants. The investigators expect that dornase alfa therapy will improve recovery
      from ventilator associated pulmonary infections in preterm infants.
    


Intervention name(s): Dornase alfa; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation; No therapy will be given to placebo arm
Other intervention name(s): Pulmozyme; Sham therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ventilator associated pulmonary infections
Improved Prostate Cancer Diagnosis - Combination of Magnetic Resonance Imaging and Biomarkers
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      Prostate cancer has been the most common cancer in men in Finland over the last ten years.
      Prostate-specific antigen (PSA) plays an important role in screening of prostate cancer.
      However, PSA has a limited sensitivity and specificity for prostate cancer detection.
      Commonly, the diagnosis of prostate cancer is done by transrectal ultrasonography (TRUS)
      guided biopsy. Due to the low accuracy of TRUS, a systematic biopsy is usually performed
      instead of targeted TRUS biopsy. As biopsy carries a risk of increase in complications, there
      is an increasing interest in developing more accurate non-invasive imaging modalities.

      This study will enroll 150 men with clinical suspicion of prostate cancer due to higher serum
      level of PSA than 2.5 ng/ml and/or abnormal digital rectal examination. Multiparametric
      magnetic resonance imaging (mpMRI) at 3 Tesla (T) magnetic field using surface coils will be
      used to non-invasively predict the presence or absence of prostate cancer. Targeted TRUS
      guided biopsy based on MRI findings will be performed in addition to routine twelve core TRUS
      biopsy. Moreover, selected serum and urine biomarkers as well as biomarkers extracted from
      fresh biopsy sample will be collected and correlated with the presence or absence of prostate
      cancer.
    


Intervention name(s): 3T MRI (Magnetom Verio 3T, Erlangen, Germany); Transrectal ultrasound (Bk Medical Pro Focus Ultraview 2202 system)
Intervention type(s): Device; Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Comparison of the Subjective Well-being and Tolerability of Quetiapine XR to Risperidone
Condition: Schizophrenic Disorders
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The trial is designed to assess the long term subjective well-being in schizophrenic
      outpatients treated with quetiapine XR (extended release) or oral risperidone at flexible
      dose in a naturalistic setting over a period of one year. Secondary outcome measures have
      been selected for helping in the differentiation of the compared atypical antipsychotics. The
      primary objective of this study is to demonstrate the non-inferiority of quetiapine XR to
      risperidone assessed at month 6 in terms of responder rate using the self-report instrument
      SWN-K
    


Intervention name(s): Quetiapine XR; Risperidone
Intervention type(s): Drug; Drug
Intervention description(s): Oral, once daily, tablets of 400 mg to 800 mg; Oral, once daily, tablets of 2 mg to 6 mg
Other intervention name(s): Seroquel XR; Risperdal
Intervention MeSH terms: Risperidone; Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: schizophrenia; SWNK
A Longitudinal Study to Evaluate an Extracellular Matrix (MatriStem®) for the Treatment of Diabetic Foot Ulcers
Condition: Neuropathic Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional

Summary: 
      This ia a prospective controlled longitudinal study to evaluate the effects of MatriStem®
      plus standard local wound care versus standard local wound care alone in the treatment of
      diabetic foot ulcers (DFUs), as assessed by incidence of complete wound healing by 16 weeks
      and ulcer recurrence with a 2 year follow-up.
    


Intervention name(s): MatriStem® [Urinary Bladder Matrix (UBM)]; Mepilex® [Silicone foam dressing]
Intervention type(s): Device; Device
Intervention description(s): Porcine derived urinary bladder extracellular matrix; primary wound dressing
Other intervention name(s): MatriStem; Mepilex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Zero-time Exercise for Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This study will examine the feasibility and effectiveness of a new lifestyle-integrated
      exercise, viz. Zero-time Exercise (ZTEx), for the management of depressive symptoms in
      Chinese adults in Hong Kong. ZTEx refers to the integration of simple strength- and
      stamina-enhancing physical activity into daily life, which can be done anytime, anywhere and
      by anyone. Depression is often accompanied by a tendency to sedentary behaviours and sleep
      disturbances, and sedentary lifestyles is associated with depression. The conventional
      psychological treatment approach for depression, viz. Cognitive Behavioural Therapy (CBT),
      emphasises the relationship between activity and mood. One of the treatment components in CBT
      for depression, viz. Behavioural Activation (BA), aims to promote activity engagement that
      are reinforcing and consistent with the long-term goals in reducing sedentary behaviour and
      increasing physical activity. The simple and brief ZTEx uses a foot-in-the-door approach to
      initiate simple behaviour change as an entry-level step for facilitating BA for participants
      with depression. A pilot randomized controlled trial (RCT) has shown some evidence on the
      effectiveness of ZTEx on improving insomnia. However, investigators have found no RCT on the
      effectiveness of ZTEx for the management of depressive symptoms.
    


Intervention name(s): Zero-time Exercise
Intervention type(s): Behavioral
Intervention description(s): A 2-hour group ZTEx training once per week for 2 consecutive weeks (totally 4 hours)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Zero-time Exercise; Depression; Lifestyle; Behavioural Activation
A Safety And Tolerability Study Of PF-05089771 In Healthy Subjects And In Subjects With Otseoarthritis Of The Knee
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is primarily to determine the safety and toleration and
      pharmacokinetics of PF-05089771 following escalating multiple doses lasting for 14 days.
    


Intervention name(s): PF-05089771; PF-05089771; PF-05089771; PF-05089771; PF-05089771
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): PF-05089771 will be dosed as a suspension twice daily (BID); PF-05089771 will be dosed as a suspension twice daily (BID); PF-05089771 will be dosed as a suspension twice daily (BID); PF-05089771 will be dosed as a suspension twice daily (BID); PF-05089771 will be dosed as a suspension BID
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pharmacokinetics and Safety of GSK1325756 in Elderly Subjects and Adult Subjects of in the Fed and Fasted States and in the Presence of a Proton Pump Inhibitors
Condition: Nutritional Status
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK1325756 is a potent, competitive, selective and reversible CXCR2 receptor antagonist that
      is being developed as a once-daily oral anti-inflammatory medication for the treatment of
      chronic obstructive pulmonary disease (COPD). Selective antagonism of the interaction between
      CXCR2 and its various chemokine ligands is a potential strategy for reducing the underlying
      inflammation in COPD via the inhibition of neutrophil recruitment and activation. The current
      study explores the effects of age, gender and food (high fat meal) on the pharmacokinetics of
      GSK1325756.

      Because a significant proportion of COPD subjects are prescribed proton pump inhibitors
      (PPI's) such as omeprazole in order to alleviate symptoms of gastro-esophageal reflux disease
      (GERD), it is important to understand the absorption of the current formulation of GSK1325756
      in an environment of raised intra-gastric pH as will be encountered in patients taking PPI's.
      Therefore, this study will also evaluate the impact of the proton pump inhibitor omeprazole
      on the pharmacokinetics of GSK1325756.
    

Detailed description: 
      GSK1325756 is a potent, competitive, selective and reversible CXCR2 receptor antagonist that
      is being developed as a once-daily oral anti-inflammatory medication for the treatment of
      chronic obstructive pulmonary disease (COPD). Selective antagonism of the interaction between
      CXCR2 and its various chemokine ligands is a potential strategy for reducing the underlying
      inflammation in COPD via the inhibition of neutrophil recruitment and activation. The current
      study explores the effects of age, gender and food (high fat meal) on the pharmacokinetics of
      GSK1325756.

      Because a significant proportion of COPD subjects are prescribed proton pump inhibitors
      (PPI's) such as omeprazole in order to alleviate symptoms of gastro-esophageal reflux disease
      (GERD), it is important to understand the absorption of the current formulation of GSK1325756
      in an environment of raised intra-gastric pH as will be encountered in patients taking PPI's.
      Therefore, this study will also evaluate the impact of the proton pump inhibitor omeprazole
      on the pharmacokinetics of GSK1325756.
    

Intervention name(s): GSK1325756; GSK1325756
Intervention type(s): Drug; Drug
Intervention description(s): 100mg of a single oral dose of GSK1325756 administered as 2 x 50mg tablets; 100mg of a single oral dose of GSK1325756 administered as 2 x 50mg tablets
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: omeprazole; proton pump inhibitor; COPD; CXCR2 inhibitor; bioavailability; food-effect
Diabetes and Partnership: Evaluation of a Diabetes Education Module
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      This study is a multi-center, randomized prospective trial with a 6-month follow up. A newly
      developed treatment and education module will be tested compared to a waiting-list control
      group. The module covers the topic "diabetes and partnership". Primary outcome variable is
      diabetes-specific empowerment regarding diabetes and partnership. Secondary outcome variables
      are: diabetes-related distress, health-related quality of life, depressive symptoms,
      self-care behavior, and glycemic control.
    

Detailed description: 
      The module consists of one lesson (duration: 90 minutes). The module is derived from the
      empowerment approach and is based on the previously evaluated education and treatment program
      for type 1 diabetes: PRIMAS (NCT01220557). The module is designed as a group session held by
      a trained diabetes educator. Patients are randomized either to the immediate participation in
      the module or to the control group. Control group is a waiting-list control group. Patients
      in this waiting-list control group get the education after the completion of the 6-month
      follow-up.
    

Intervention name(s): Education - Diabetes and Partnership
Intervention type(s): Behavioral
Intervention description(s): Based on the treatment and education programme PRIMAS a problem-specific education module regarding "Diabetes and Partnership" was created. The module covers specific and detailed aspects of the topic "partnership" such as dealing with hypoglycemia, late complications, and talking about diabetes in a relationship. With this module, a more comprehensive education of patients with specific interest in these topics is possible.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; education; randomized; prospective
Fuzheng Huayu Tablets Against Posthepatitic Cirrhosis
Condition: Posthepatitic Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary purpose of the trial is adopted Fuzheng Huayu tablets against posthepatitic
      cirrhosis, and to build a standard evaluation system for efficacy of traditional Chinese
      medicine (TCM).

      The second purpose is according to the international clinical guideline and the specialty of
      TCM to build a standard clinical trial regulation for traditional Chinese medicine.
    


Intervention name(s): Fuzheng Huayu Tablets; sham Fuzheng Huayu Tablets (placebo)
Intervention type(s): Drug; Drug
Intervention description(s): Tablet,three times a day,four tablets one time; Tablet, three times a day, four tablets one time
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fuzheng Huayu Tablets; Multicenter clinical study
Promoting Healthy Lifestyles Using Mobile Phones
Condition: Health Behavior
Study type: Interventional

Summary: 
      The purpose of this research is to test programs to increase physical activity and reduce
      sedentary behavior using motivational messages over a cell phone.
    

Detailed description: 
      We want to learn if conceptually-based behavioral interventions for promoting increased
      physical activity and decreased sedentary behavior via state-of-the-art mobile phones will be
      efficacious at improving these behaviors relative to commercially available Android
      applications as a control. If efficacious, these types of intervention programs could be
      disseminated to a wide variety of sedentary and underactive adults at a relatively low cost.
      This could have a potentially significant impact on promoting improved health such as reduced
      obesity, a key problem within the U.S.
    

Intervention name(s): Mobile Intervention for Lifestyle Eating/Exercise @ Stanford
Intervention type(s): Behavioral
Intervention description(s): Participants are randomized to one of 4 groups, each of which uses a different Smartphone app to promote health behavior change
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Health Promotion; Physical Activity; Sedentary Time; Smartphones
Filgrastim for Premature Ovarian Insufficiency
Condition: Premature Ovarian Failure
MeSH terms: Premature Birth; Primary Ovarian Insufficiency; Menopause, Premature
Study type: Interventional
Phase: Phase 4

Summary: 
      Filgrastim is a Granulocyte-Colony Stimulating factor (G-CSF). It is an FDA approved drug.
      Very small embryonic-like stem cells (VSELs) are found in the ovary. Animal studies showed
      that these cells are able to regenerate the affected ovary. Studies on mice have shown that
      Filgrastim result in recovery of oogenesis after chemotherapy-induced gonadal failure (in
      2013, 2014, and 2015).
    

Detailed description: 
      Premature ovarian insufficiency (POI) has no curative treatment until now. Filgrastim is an
      FDA approved Granulocyte-Colony Stimulating factor (G-CSF). Very small embryonic-like stem
      cells (VSELs) are found in the testis and ovary. VSELs are stem cells that have noticed to
      survive chemotherapy induced gonadal failure. Data from animal studies showed that
      stimulation of these stem cells result in generation of the affected gonads. Studies on mice
      have shown a promising stimulating effect of Filgrastim on recovery of spermatogenesis and
      oogenesis after chemotherapy-induced gonadal failure (in 2013, 2014, and 2015).
    

Intervention name(s): Filgrastim; Saline
Intervention type(s): Biological; Drug
Intervention description(s): Each case will have two intervention phases done blindly at random with a wash-out period of 6 months:
Phase A:
Filgrastim vial (30 million IU/ml) SC injection twice daily for five consecutive days.
Phase B:
Injection of saline SC injection twice daily for five consecutive days.; Injection of saline SC injection twice daily for five consecutive days
Other intervention name(s): Granulocyte-Colony Stimulating Factor (G-CSF); placebo
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Premature; Ovarian; Failure; Filgrastim
Multidisciplinary Services to Enhance HIV Testing and Linkage to Care Among MSM
Condition: HIV Testing; Linkage to Care
Study type: Observational

Summary: 
      Objectives

        1. To determine the impact of MSM-targeted multidisciplinary services on uptake of HIV
           voluntary counseling and testing (VCT)

        2. To determine the impact of MSM-targeted multidisciplinary services on the enrollment
           into care and retention of HIV-positive MSM

      Subject population: HIV-negative and HIV-positive MSM clients, age ≥18 years old, of the Thai
      Red Cross Anonymous Clinic (TRC-AC) in Bangkok Thailand, the Cipto Mangunkusumo Hospital in
      Jakarta, and the Sanglah Hospital in Bali, Indonesia

      Number of participants: 200 HIV-negative and 150 HIV-positive MSM participants
    

Detailed description: 
      This is a prospective cohort study which will recruit 350 MSM clients within 3 months, and
      follow them for 12 months. MSM to be recruited will be first-time clients who come to the
      clinics for services other than VCT. These services may include but would not be limited to
      sexually transmitted infection (STI) diagnosis and treatment, anal dysplasia screening,
      nutritional counseling and non-occupational post-exposure prophylaxis (nPEP).

      Approximately 250 MSM clients with unknown or previously negative HIV status will be offered
      HIV testing every 3 months (HIV-negative MSM cohort). MSM from the HIV-negative cohort who
      tested HIV-positive during the study (estimated 20%, 50 MSM) will be referred to the
      HIV-positive MSM cohort and will be followed up every 6 months. Additional clients who visit
      the clinic during the 3-month recruitment period with previously known HIV-positive status
      but have not been linked to HIV care (up to 100) will also be enrolled into HIV-positive MSM
      cohort. Therefore, there will be up to 150 HIV-positive subjects enrolled in this study. Each
      enrolled participant will have 12 months in the study.

      This study will allow us to assess VCT and linkage into care, as well as HIV risk behavior
      and need for nPEP, and the incidence or prevalence of important morbidities in MSM such as
      STIs, anal dysplasia/cancer, hyperlipidemia, and diabetes.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        MSM with HIV negative and positive MSM in Thai Red Cross Bangkok Thailand, the Cipto
        Mangunkusumo Hospital in Jakarta, and the Sanglah Hospital in Bali, Indonesia
      
Keywords: To assess VCT and linkage into care; nPEP; STIs; anal dysplasia/cancer; hyperlipidemia; diabetes; Proportion of first-time MSM clients attending multidisciplinary services who undergo HIV testing; Proportion of MSM clients who have repeated HIV testing during the first six months after the first negative HIV test; Proportion of HIV-positive MSM who receive HIV care within three months after HIV diagnosis or enrolment; Proportion of HIV-positive MSM who still remain in HIV care at six months after enrollment
Can the Different Instruments Used ın Root Canal Treatment Have an Effect on Postoperative Pain?
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Root canal treatment is a treatment method in which the pulp is irreversibly infected due to
      caries or trauma or when the pulp loses its vitality. Biomechanical preparation of primary
      teeth is an important step for a successful root canal treatment. The success of root canal
      treatment depends not only on the biological results of the treatment, but also on minimizing
      the postoperative pain of the patients. Therefore, the elimination of factors associated with
      postoperative pain has an important role in the prognosis of patients after treatment. In all
      root canal preparation methods, some debris overflows from the apical. Debris protruding into
      the apical area causes postoperative pain. Many studies in the literature have shown that
      NiTi rotary files cause less extrusion of debris compared to hand files, and therefore less
      postoperative pain. Within the scope of this study, the effect of NiTi K hand file and
      WaveOne Gold, ProTaper Next, EndoArt NiTi Pedo Gold file, AF Baby rotary file systems on
      postoperative pain in root canal treatment preparations applied to the mandibular primary
      molar teeth of pediatric patients aged 5-8 years. It is intended to be evaluated using VAS).

      In our research; ProTaper Next (PTN), WaveOne Gold (WOG), AF Baby rotary file, EndoArt NiTi
      Pedo Gold file, NiTi K type hand files were used. 100 patients between the ages of 5 and 8
      who had root canal treatment indications for mandibular primary second molars were included
      in the study. The patients were divided into 5 groups with 20 patients in each group. All
      systems were used according to the manufacturer's instructions and all treatments were
      performed by a single operator in a single session. Postoperative pain was recorded using the
      Visual Analog Scale (VAS) at the 6th, 12th, 18th, 24th, 48th, 72nd hour and 1st week
      following treatment. The obtained data were evaluated statistically.
    


Intervention name(s): Hand K-files
Intervention type(s): Procedure
Intervention description(s): It is used for cleaning and shaping root canals.
Other intervention name(s): ProTaper Next; WaveOne Gold; AF Baby Rotary File; EndoArt NiTi Pedo Golf File
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Root canal treatment; Nickel-Titanium instruments; Postoperative pain; Primary tooth