bioihbjkbjnl/mcl2 huggingface dataset:
Chronic Sleep Deprivation Among the Poor: A Lab-in-the-field Approach
Condition: Blood Pressure; Depression
MeSH terms: Sleep Deprivation
Study type: Interventional

Summary: 
      A large body of medical research has shown that sleep deprivation adversely affects outcomes
      ranging from cognitive function to pain sensitivity and cardiovascular function. Much of this
      evidence comes from sleep labs in the developed world, where sleep can be carefully
      manipulated, and short-run physiological and cognitive outcomes precisely measured. In
      contrast, there is much less knowledge about how sleep deprivation affects the health of
      individuals in the developing world, coming from a lack of studies outside the lab and over
      longer periods. This project aims to fill this gap. The investigators will implement a
      randomized controlled trial (RCT) with 450 low-income adults in Chennai, India, providing the
      first objective measurement of sleep in a developing country. The investigators will also
      evaluate scalable interventions to improve the sleep of poor adults, such as providing home
      sleep-aid devices and a comfortable space for a 30-minute afternoon nap at the participants'
      work site. Finally, the study aims to assess the impact of improved sleep on health, with a
      primary focus on cardiovascular health and cognitive outcomes.
    


Intervention name(s): Naps; Home sleep aids; Sleep incentives
Intervention type(s): Other; Device; Other
Intervention description(s): After a baseline period, participants in this condition will be provided with the opportunity to nap in a quiet comfortable "nap cabin" in the study office for 30 minutes each afternoon on all work days.; After a baseline period, participants in this condition will be provided with a set of home sleep aids (e.g. earplugs, eyeshades, a basic mattress, sheets, and pillow, etc) to take home with them if they wish. These sleep aids and their proper use are described to the participants and they are encouraged to use them if they find them helpful.; After a baseline period, participants in this condition will be provided with a small payment for each additional minute of sleep over their mean nighttime sleep in the baseline period.
Intervention MeSH terms: Diphenhydramine; Promethazine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of the Use of Ketamine in Laparoscopic Surgery.
Condition: Quality of Recovery
Study type: Interventional
Phase: Phase 4

Summary: 
      In order to improve the postoperative period (namely pain control), several drugs can be
      used. For instance, ketamine is a general anesthetic that holds strong analgesic properties,
      yet also owns undesirable effects, in which hallucination phenomena is one the most common
      indicator. However, slight information is available about the real implication in the quality
      of the recovery on the use of ketamine for postoperative pain treatment. The quality of the
      recovery includes several health conditions, such as pain, physical comfort, physical
      independence, psychological support and emotional state. In recent years, investigations in
      this field has been attracted the attention by the health professionals, since is an
      indicator of the quality of post-operative care. To evaluate these parameters, questionnaires
      have been developed, in which the Portuguese version of Quality of Recovery 15 (QoR-15) is
      include. This questionnaire evaluates five psychometric dimensions. Therefore, the present
      study has the main goal, the evaluation of the effect of using ketamine in laparoscopic
      surgery and the quality of the recovery using the QoR-15 questionnaire.
    


Intervention name(s): Ketamine
Intervention type(s): Drug
Intervention description(s): Administration of 0.5mg / kg ideal body weight of ketamine at induction of anesthesia in laparoscopic surgery.
Intervention MeSH terms: Ketamine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Ketamine; QoR-15; Laparoscopic surgery
Evaluation of Safety and Efficacy of Intravenous Sulbactam-ETX2514 in the Treatment of Hospitalized Adults With Complicated Urinary Tract Infections
Condition: Complicated Urinary Tract Infection; Acute Pyelonephritis
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Pyelonephritis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a double-blind, randomized, placebo-controlled study to evaluate the safety and
      efficacy of IV ETX2514SUL in patients with complicated urinary tract infections (cUTIs) who
      are otherwise relatively healthy.
    

Detailed description: 
      This study is a double-blind, randomized, placebo-controlled study to evaluate the safety and
      efficacy of IV ETX2514SUL in patients with cUTIs who are otherwise relatively healthy.
      Patients with Acute Pyelonephritis may also be enrolled. Approximately 80 patients will be
      randomized to receive either 1 g ETX2514/1 g sulbactam IV or matching placebo every 6 hours
      (q6h). All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.
    

Intervention name(s): Sulbactam-ETX2514; Placebo; Imipenem-cilastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The ETX2514SUL regimen of 1 g ETX2514/1 g sulbactam infused over 3 hours q6h.; Matching 1g IV solution.; All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.
Other intervention name(s): ETX2514SUL
Intervention MeSH terms: Imipenem; Sulbactam; Cilastatin, Imipenem Drug Combination; Durlobactam; Cilastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is a double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of IV ETX2514SUL in patients with cUTIs.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate Meningococcal Serogroups A,C,W-135,Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 18-25 Years
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, reactogenicity, immunogenicity and
      persistence up to three years after administration of one dose of the MenACWY conjugate
      vaccine when given to young adults aged 18-25 years.
    

Detailed description: 
      Administration of the candidate vaccine or of the active control (Mencevax™ ACWY) will be
      done in an open manner. The study consists of a vaccination phase during which subjects
      receive one vaccine dose (GSK's MenACWY conjugate vaccine or Mencevax™ ACWY vaccine) and 3
      years of follow-up. There are in total 7 visits to the doctor: before and 2, 7 and 30 days
      after vaccination (vaccination phase) as well as 12, 24 and 36 months after vaccination
      (follow-up phase). 7 blood samples are taken: one at each visit.
    

Intervention name(s): Meningococcal (vaccine)
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Evaluation of Effectiveness of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A Against Invasive Disease
Condition: Infections, Streptococcal; Streptococcus Pneumoniae
MeSH terms: Pneumonia; Pneumonia, Pneumococcal; Streptococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to assess the effectiveness of GSK Biologicals' pneumococcal
      conjugate vaccine (GSK1024850A), administered according to different vaccination schedules,
      against invasive disease caused by S. pneumoniae or H. influenzae as well as vaccine impact
      on the occurrence of hospital-diagnosed pneumonia cases, tympanostomy tube placement and
      outpatient antimicrobial prescriptions.

      This study will also explore vaccine impact on occurrence of respiratory tract infections
      (RTIs), including acute otitis media (AOM) in a subset of children in Turku area.
    

Detailed description: 
      The protocol posting has been updated with regards to the enrolment of subjects and outcome
      measures following Protocol amendment 2, 22 August 2011.
    

Intervention name(s): Pneumococcal conjugate vaccine GSK1024850A; GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine); GSK Biologicals' Havrix TM vaccine (Hepatitis A vaccine)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 2, 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination; 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination.
Control 3+1 and Control 2+1 groups, only for children < 12 months of age at the time of first study vaccination.; 2 Intramuscular injections. Control 3+1 and Control 2+1 groups, only for children >= 12 months of age at the time of first study vaccination.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Pneumococcal conjugate vaccine; Invasive disease; Respiratory tract infections; Haemophilus influenzae; Streptococcus pneumoniae; Acute otitis media; Pneumonia
KTP Green Light Prostatectomy Compared With Open Prostatectomy
Condition: BPH (Benign Prostatic Hyperplasia)
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare safety and efficacy of Green Light PVP
      (Photoselective Vaporisation of the Prostate) compared to open prostatectomy when treating
      benign prostatic hyperplasia (BPH).
    


Intervention name(s): KTP Green Light Prostatectomy; Green Light; Open prostatectomy
Intervention type(s): Procedure; Device; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical and Radiographic Evaluation of Low-Level Diode Laser Full Pulpotomy in Vital Permanent Teeth
Condition: Irreversible Pulpitis; Endodontic Inflammation
MeSH terms: Pulpitis; Inflammation
Study type: Interventional

Summary: 
      In this study, patients with symptoms of irreversible pulpitis in mature permanent molars
      were treated with two pulpotomies techniques after random allocation in either 2 groups:
      Diode laser pulpotomy and traditional pulpotomy using bioactive materials (retro mineral
      trioxide aggregate ) with each group.The null hypothesis of the study was there would be no
      difference in success rate between Diode laser and traditional methods of adult pulpotomy .
    

Detailed description: 
      In this study, 40 patients with symptoms of irreversible pulpitis in mature permanent 1st and
      2nd molars were treated with two pulpotomy techniques after random allocation in either 2
      groups: traditional pulpotomy and low-level diode laser pulpotomy. The pulp in each group was
      capped with Retro MTA . In the traditional pulpotomy group, the coronal pulp was removed by
      the traditional method while in the low-level diode laser pulpotomy group, the radicular pulp
      was biostimulated using low-level diode laser beam with parameters (970nm, power .5Watt, duty
      cycle 50%, and frequency 5H) 10 sec for each pulp stump in non-contact mode. After that, the
      capping material was prepared as manufacturer's instructions and applied over the pulp stamp,
      the final restoration was then placed in both groups. Patients were followed up after 6, 12,
      and 18 months to evaluate success and failure.
    

Intervention name(s): traditional pulpotomy; diode laser pulpotomy
Intervention type(s): Other; Device
Intervention description(s): After complete deroofing, the coronal pulp was amputated to the level of the orifice using a high-speed size #2 round bur followed by rinsing the pulp chamber thoroughly with 5ml 0.9% saline solution.Hemostasis was then achieved by placing a sterile cotton pellet moistened with saline in the access cavity for 6 min.Retro MTA capping material was then applied,; after establishing hemostasis, low-level laser energy at (970nm, power .5W, duty cycle 50%, and frequency 5H) was applied to each pulp stump for 10 sec. through 320 microns optical fiber tip . The laser was used in pulsed non-contact mode at the level of the occlusal surface of the tooth.Retro MTA capping material was then applied,
Other intervention name(s): full pulpotomy; laser biostimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Full pulpotomy; Low-level Diode Laser
Characterization of Immune Semaphorin in Non Alcoholic Fatty Liver Disease and NASH
Condition: Non Alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      Recent epidemiological studies in France showed a high prevalence of obesity (14.5%) and its
      strong increase in the last 20 years. Among the many complications associated with obesity,
      liver complications (steatosis and steatohepatitis [NASH]) are among the most common.
      Semaphorins were described in the early 1990. More than 20 types of these proteins have been
      reported to date. These proteins were used for neural development. Since many functions have
      also been described. The semaphorins are involved in numerous physiological or
      physiopathological processes (cardiac morphogenesis, vascular growth, tumor progression), the
      regulation of immune cells and liver fibrosis. Preliminary studies have allowed to show that
      dendritic cells infiltrate adipose tissue and initiate the activation of T cells and
      inflammation. Immune semaphorin are new players in the regulation of inflammation and immune
      reactions.

      The role of immune semaphorin in regulating inflammation in the two compartments (liver and
      adipose tissue) could be a crucial step that could lead to more severe liver damage. Its
      dysregulation could explain NASH injuries. The goal is to identify a new mode of regulation
      of cellular homeostasis in the fatty liver disease. These factors may serve as diagnostic
      markers or future therapeutic targets.
    


Intervention name(s): Evaluation of the staging of fibrosis liver; Determine the expression level of semaphorin; Determination of the composition of immunity cells
Intervention type(s): Other; Other; Other
Intervention description(s): The investigators will determine the severity of steatosis, inflammation and fibrosis by histological study of liver biopsies; The investigators will determine the expression level (gene and protein) of immune semaphorin and their (s) receptor (s) in the liver and subcutaneous and visceral adipose tissue by RT-PCR,; The investigators determine the composition of immunity cells by immunohistochemical and biochemical analyses (Western Blotting
)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
HCT Effect Among Patients With Psychotic Disorders
Condition: Psychotic Disorders
MeSH terms: Mental Disorders; Psychotic Disorders
Study type: Interventional

Summary: 
      Horticulture therapy has been found to have positive effects on individuals with psychotic
      disorders, promoting social interaction, reducing social isolation, and improving cognitive
      function. Effectiveness of horticulture therapy in enhancing well-being, reducing symptoms,
      and facilitating social adjustment in this population
    

Detailed description: 
      Horticulture therapy involves gardening and plant-related activities as a form of therapeutic
      intervention, enhance patient to be mindful to current environment and promote relaxation
      which can reduce symptoms such as anxiety, depression, and social isolation, improve
      cognitive function, and promote overall well-being .With this respect, there is an urgent
      need to find a sustainable and eco-friendly solution for this complex issue by returned to
      nature and utilizing the low cost and current resources at the same time to make a
      signification reduction in the psychotic disorder's symptoms
    

Intervention name(s): Horticultural Therapy Program
Intervention type(s): Behavioral
Intervention description(s): Horticultural Therapy Program Is selected plant therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Hope; Psychological Adjustment; Psychological Wellbeing; Horticulture Therapy
Effects of Infliximab (Remicade) on Fat Free Mass in Patients With Moderate to Severe COPD Suffering From Cachexia
Condition: COPD; Cachexia
MeSH terms: Wasting Syndrome; Cachexia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether infliximab is effective on fat-free mass in
      the treatment of patients with moderate to severe COPD suffering from cachexia.
    

Detailed description: 
      COPD is a multicomponent disease characterized by abnormal inflammatory response of the lungs
      to noxious particles that accompanied by systemic effects like weight loss, muscle wasting,
      reduced functional capacity and health status. A persistent systemic inflammatory response
      reflected by enhanced levels of acute phase proteins like C-reactive protein (CRP) or
      pro-inflammatory cytokines such as tumor necrosis factor (TNF) - α, is present in COPD. There
      are several studies that indicate that an increased systemic inflammator response is
      associated with weight loss, cachexia (loss of fat-free muscle mass), physical functioning
      and health status.

      Cachexia associated with systemivc inflammation can not always readily be overcome by
      nutritional intervention alone.

      The hypothesis of this study is that infliximab therapy (3 infusions with 5 mg/kg infliximab
      or placebo 1:1 on week 0, 2 and 6) will increase fat-free mass relatively to placebo by
      decreasing inflammation. Secondary endpoints are: lung function, muscle function, exercise
      capacity and health status. On week 8, 12 and 26 follow-up measurements will be done.
    

Intervention name(s): infliximab (Remicade)
Intervention type(s): Drug
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: COPD; infliximab; Remicade; inflammation; cachexia; fat-free mass; health status; exercise capacity
Safety and Tolerability Study of BMS-986177 in Healthy Subjects
Condition: Thrombosis
MeSH terms: Thrombosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of
      BMS-986177 in healthy subjects
    


Intervention name(s): BMS-986177; Placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
TASK-002: Bioequivalence of Bedaquiline 400mg Administered in Crushed Form Compared to Tablet Form in Healthy Male and Female Adults Under Fed Conditions (BDQ Crush Study)
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a randomized, open-label, cross-over study comparing the bioequivalence of
      bedaquiline administered in whole tablet form versus bedaquiline administered in crushed
      (experimental) form in healthy adult volunteers.
    

Detailed description: 
      This is a randomized, open-label, cross-over, bioequivalence study with two single treatment
      periods, separated by a 14-day wash-out period, conducted among 24 healthy adult males and
      females, who receive 400mg (4 x 100mg) bedaquiline orally in one of two sequences: either
      first in whole tablet form and second in crushed (experimental) form, or vice versa under fed
      conditions. The bioequivalence evaluation will be based on primary pharmacokinetic (pk)
      parameters affecting the extent of absorption, i.e., the bioavailability. If bioequivalence
      is not shown, the knowledge about the differences in bioavailability between whole and
      crushed tablets will be used for assessing the need of dose adjustment in children receiving
      the crushed form.
    

Intervention name(s): bedaquiline
Intervention type(s): Drug
Other intervention name(s): Sirturo
Intervention MeSH terms: Bedaquiline
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants are randomized to receive study drug (bedaquiline (BDQ)) in either tablet form or crushed form in one of two sequences:
Sequence 1: BDQ 4 x 100mg administered in a whole tablet form, followed by BDQ 4 x 100mg administered in crushed form as a once only dose
Sequence 2: BDQ 4 x 100mg administered in crushed form, followed by BDQ 4 x 100mg administered in tablet form as a once only dose
Masking: None (Open Label)
Primary purpose: Other