bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Tolerability, Efficacy and Pharmacodynamics of CAL02 in Severe Pneumonia Caused by Streptococcus Pneumoniae
Condition: Pneumonia; Pneumococcal Infections
MeSH terms: Pneumonia; Pneumonia, Pneumococcal; Pneumococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study are to assess the safety, tolerability, clinical and
      microbiological efficacy and pharmacodynamics of patients who have severe pneumonia caused by
      Streptococcus pneumoniae after the intravenous administration of CAL02 in addition of
      standard of care antibiotic treatment.
    

Detailed description: 
      Streptococcus pneumoniae is the most frequently identified pathogen of community-acquired
      bacterial pneumonia and its severe forms are associated with high morbidity and mortality,
      despite pneumococcal vaccines and medical treatment (antibiotic therapy, alone or in
      combination). Bacterial toxins, such as the pore-forming toxin (PFT) pneumolysin (from
      Streptococcus pneumoniae), are involved in the development of invasive disease and play a key
      role in severe and fatal complications. CAL02 offers a novel therapeutic approach by
      neutralising bacterial toxins, such as pneumolysin, which recognise specific microdomains on
      host cell membranes, called lipid rafts.
    

Intervention name(s): CAL02 Low-dose; CAL02 High-dose; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Two doses of CAL02 (low-dose) administered 2 times (24 hours apart) as i.v. infusion; Two doses of CAL02 (high-dose) administered 2 times (24 hours apart) as i.v. infusion; Placebo administered administered 2 times (24 hours apart) as i.v. infusion
Other intervention name(s): CAL02 LD; CAL02 HD; Placebo CAL02
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pneumonia; Streptococcus pneumoniae; Pneumolysin
Time to Intubation (TTI) of Obese Patients. A Comparison Macintosh Laryngoscope and Stortz Video Laryngoscope
Condition: Obese
MeSH terms: Obesity
Study type: Observational

Summary: 
      The purpose of the study is to investigate wether the use of the Stortz video laryngoscope
      will render in shorter time for the intubation of obese patients compared with the use of a
      conventional Macintosh laryngoscope.
    

Detailed description: 
      Obese patients are prone to develop desaturation soon after initiation of anaesthesia
      compared to patients of normal body weight. It is therefore important to keep the time from
      when spontaneous breathing to when the airway is secured with a orotracheal tube as short as
      possible. We will therefore investigate if it is possible to shorten this time by using a
      Stortz videolaryngoscope.

      Patients 18-60 years with ASA grade 1-3 and BMI < 35 that turn up for planned surgery that
      demands the use of orotracheal tubing and controlled ventilation will be randomly and
      consecutively enrolled in either of two groups. Patients in both groups will be anaesthetised
      with the same combination of drugs using Propofol and Remifentanyl or Fentanyl for induction
      of sleep, combined with Rocuronium for muscle relaxation.

      After the induction and relaxation the intubation will be facilitated using either of two
      laryngoscopes. In the first group a conventional Macintosh laryngoscope, and in the second
      group a Stortz videolaryngoscope will be used. The time to intubation is defined as the time
      from grabbing the laryngoscope to when the tube has been inserted and end-tidal carbon
      dioxide appears on the monitor. Our hypothesis is that we will be able to achieve a faster
      intubation with the use of videolaryngoscope.
    

Intervention name(s): Conventional Macintosh laryngoscope; Stortz videolaryngoscope
Intervention type(s): Device; Device
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        In-patients from the University hospital of Orebro who will go through planned surgery
Pilot Study to Evaluate A Novel Gastric Space Occupying Device
Condition: Obesity
Study type: Observational

Summary: 
      This will be an observational, prospective, non-randomized, pilot study to gain initial
      device experience on a novel space-occupying device in persons who are overweight or obese.
      No formal hypothesis testing will be conducted.
    


Intervention name(s): Obalon Gastric Balloon(s)
Intervention type(s): Device
Intervention description(s): One or two balloons administered per patient
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Overweight or obese individuals who have failed routine dieting in the past
Pharmacokinetics and Safety of BI 201335 in Patients With Mild to Severe Renal Impairment
Condition: Hepatitis C
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this study is to investigate the influence of mild, moderate and severe
      renal impairment on the pharmacokinetics and safety of BI 201335 in comparison to a control
      group with normal renal function after single dose of BI 201335.
    


Intervention name(s): BI 201335; BI 201335
Intervention type(s): Drug; Drug
Intervention description(s): Relevant treatment dose capsule (A) for oral administration; Relevant treatment dose capsule (B) for oral administration
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phytoestrogens and Colonic Adenomatous Polyps
Condition: Intestinal Polyps
MeSH terms: Adenomatous Polyps; Polyps; Intestinal Polyps
Study type: Observational [Patient Registry]

Summary: 
      INTRODUCTION: The data obtained by experimental studies about the influence of phytoestrogens
      on colorectal cancer (CRC) have been very promising. On the other hand, clinical trials have
      produced conflicting results. The literature suggests that some subclasses of phytoestrogens
      may have protective effects against CRC and colon adenomas, but most of these results come
      from population studies based on the dietary intake of phytoestrogens. On these premises, it
      is possible to hypothesize that the variability of the data reported in the literature may be
      due to the fact that the real absorption of phytoestrogens (by assessing their concentration
      in the serum or urine) and/or the ability of the single individual of producing equol was not
      evaluated.

      PURPOSE: In the present study, the association between the phytoestrogens intake and the
      prevalence of colon adenomas was evaluated not only on the basis of the simply dietary intake
      but also on the measurement their intestinal absorption. Moreover, a specific evaluation of
      equol production by the intestinal flora was performed. Finally, intestinal bacteria involved
      in equol production were evaluated.
    

Detailed description: 
      MATERIALS AND METHODS: Patients with sporadic colon adenomas were enrolled in group I (case)
      and patients without sporadic colorectal adenomas matched for sex, age and BMI were enrolled
      in group II (control). All participants underwent the following evaluations: BMI, dietary
      history (for quantitative and qualitative analysis of dietary habits), quantitative analysis
      of phytoestrogens (by dietary questionnaires), medications (chronic assumption of aspirin at
      low doses), characteristics of the polyps (for a calculation the cancer risk), analysis of
      urinary excretion of phytoestrogens [by high pressure liquid chromatography (HPLC)] and
      intestinal flora [by mass spectrometry with Matrix Assisted Laser Desorption Ionization
      Time-of-Flight (MALDI-TOF) technology]. At the enrolment, patients will be invited to assume
      a standard quantitative of phytoestrogens at 8:00 a.am. and collect both a fecal sample and
      the urine of the following 24 hrs.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All patients (aged between 50 and 75 years) undergoing colonoscopy within 3 months from the
        study evaluation.
      
Biospecimen description: 
      Urine, feces
    
Keywords: phytoestrogens; isoflavones; adenomatous polyps; microbiome
Sonographic Hysterosalpingography: Oil vs Water Based Media (SHOW Trial)
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      Performing fluoroscopic HSG with oil based contrast medium has been shown to increase
      pregnancy rates in a subfertile population. This is a pilot study to test the efficacy of as
      well as the tolerability and safety of using lipid based oil medium for sonographic based
      hysterosalpingography (Sono HSG) compared to water based contrast (i.e. normal saline) for
      women seeking fertility. The double blind study will randomize 56 women at the time of Sono
      HSG in a 1:1 ratio to receive through the SHG catheter either up to 10 cc of Lipiodol UF® or
      normal saline. The investigators will collect subjective pain experience and follow the
      subjects for 6 months after the test for pregnancy and collect all adverse events during and
      after the procedure.
    


Intervention name(s): Lipiodol UF; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Up to 10cc of Lipiodol Ultra Fluid will be infused via intrauterine catheter; Up to 10cc of saline will be infused via intrauterine catheter
Other intervention name(s): Lipiodol Ultra Fluid
Intervention MeSH terms: Ethiodized Oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study on the Effects of Feeding and Feeding Methods on Breathing Pattern in Very Low Birth Weight Preterm Infants
Condition: Infant, Premature; Apnea
MeSH terms: Birth Weight
Study type: Observational

Summary: 
      In this study, we want to see how feeding affects breathing in small premature babies. Using
      a special feeding tube in the stomach, we can measure how the diaphragm (a large breathing
      muscle) might be affected by feeding. We also want to see if slowing down the feeding may
      lessen this effect.
    

Detailed description: 
      Premature babies may have pauses in breathing known as apnea, which may require invasive
      treatment. The exact cause of apnea is unknown, and may be related to a combination of brain,
      gut, and lung immaturity.

      Research in premature babies suggests that feeding may affect lung functions, but such
      effects may be lessened if feeds are given at a slower rate. Further research showed that the
      diaphragm, an important breathing muscle, may be fatigued by a full stomach. We speculate
      that, in premature babies, feeding might tire the diaphragm, thus impairing lung function and
      possibly causing apnea.

      We plan to study 10 stable premature babies less than 23 weeks and 1.25 kilograms at birth.
      By inserting a special feeding tube with sensors into the stomach, we can measure the
      electrical activity of the diaphragm (EAdi). By analysing EAdi before and after feeding, we
      want to directly measure how feeding might affect lung functions. We also want to compare
      feeding at the usual rate (5-15 minutes) versus a slower rate (90 minutes) to see how their
      effects on lung functions might differ.

      This important study will help us determine the most appropriate treatment for premature
      babies with apnea related to feeding.
    

Intervention name(s): Insertion of specialized feeding tube for monitoring of EAdi
Intervention type(s): Device
Intervention description(s): The specialized feeding tube will be inserted into the esophagus and positioned at the level of the crural diaphragm. EAdi will be measured with miniaturized coated stainless steel electrodes mounted on the feeding tube. The tube is connected to a monitor where EAdi will be recorded continuously throughout the entire study period
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Premature infants admitted to the Neonatal Intensive Care Unit of Sunnybrook Health
        Sciences Centre
      
Keywords: Infant, premature; Infant, very low birth weight; Apnea; Feeding methods; Diaphragm
Role of Dopamine Transporter in Glucose Control
Condition: Obesity
Study type: Interventional

Summary: 
      Healthy subjects will be enrolled in this study. Each subject will be scanned twice with
      F18-FP-CIT PET which is commercially available. F18-FP-CIT reflects dopamine transporter
      availability of striatum. Before each PET scan, subject will be injected either glucose or
      normal saline. Therefore, PET scan will reflect the changes of dopamine transporter
      availability after the injection of glucose.
    


Intervention name(s): Glucose injection/Normal saline injection
Intervention type(s): Other
Intervention description(s): Before each PET scan, subject will be injected either glucose or normal saline.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Evaluate the Efficacy and Safety of VVZ-149 Injections for the Treatment of Postoperative Pain Following Bunionectomy
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this phase 2 study is to evaluate the efficacy and safety of an analgesic drug
      candidate, VVZ-149 Injections for treating post-operative pain following bunionectomy.
    


Intervention name(s): VVZ-149 Injections; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): IV infusion of 1000 mg of VVZ-149; IV infusion of 0 mg of VVZ-149
Other intervention name(s): Opiranserin Injections
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and potential effectiveness of CCX140-B
      in subjects with Type 2 diabetes mellitus.
    

Detailed description: 
      The primary objective of this study is to evaluate the safety and tolerability of CCX140-B in
      subjects with Type 2 diabetes mellitus (T2DM) based on subject incidence of adverse events.

      The secondary objectives of this study include evaluation of the effect of CCX140-B on
      several measures of effectiveness commonly used in the evaluation of diabetes medications.
    

Intervention name(s): Placebo; pioglitazone; CCX140-B; CCX140-B
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Placebo capsules once daily; pioglitazone 30 mg tablet once daily; CCX140-B capsules once daily (Group C); CCX140-B capsules once daily (Group D)
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Impact of Systemic Corticosteroid Therapy on Lens Transparency and Quantification of Lens Autofluorescence.
Condition: Patients With Systemic Inflammatory Diseases Receiving for the First Time a Protracted General Corticostroid Therapy
Study type: Interventional

Summary: 
      Corticosteroid therapy is usually regarded as a risk factor for the development of posterior
      subcapsular cataracts but prospective studies on this topic and accurate assessment of this
      potential adverse effect are lacking. We will evaluate changes of lens transparency after
      administration of systemic corticosteroid therapy for at least one year with Scheimpflug
      photography and quantification of lens autofluorescence.
    

Detailed description: 
      Corticosteroid therapy is usually regarded as a risk factor for the development of posterior
      subcapsular cataracts but prospective studies on this topic and accurate assessment of this
      potential adverse effect are lacking. We will evaluate changes of lens transparency after
      administration of systemic corticosteroid therapy for at least one year with Scheimpflug
      photography and quantification of lens autofluorescence.
    

Intervention name(s): Prednisolone
Intervention type(s): Drug
Intervention MeSH terms: Prednisolone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cataracts; Corticosteroids; Scheimpflug; Lens autofluorescence
The Impact of Epidural Fat Resection on Postoperative Outcomes in Posterior Surgery of Lumbar Spine
Condition: Spinal Stenosis
MeSH terms: Spinal Stenosis
Study type: Interventional

Summary: 
      Posterior lumbar epidural fat commonly had been considered a simple space-filling tissue.
      Anatomic studies on posterior epidural space and its contents are few, including semifluid
      property. In other words, there has not been studied thoroughly regarding the significance
      and role of posterior epidural fat in lumbar spine. In adults, epidural fat situated in the
      posterior triangle limited by the lamina, the ligamentum flavum, and the posterior surface of
      thecal sac. The fat tissue was covered by a thin membrane of connective tissue, which were
      free under this layer. The anterior surface of this membrane lay close to the dura mater
      without any attachment.

      To date, the epidural fat has been resected routinely by pituitary forcep and suction
      drainage during posterior lumbar surgery. However, the investigators focused on the role of
      epidural fat, which might be associated with postoperative outcome. The investigators thought
      that this peculiar character, epidural fat, should be caused by certain etiologies. In
      general, each tissue, such as epidural fat, has its inherited features and significance,
      thereby the epidural fat has also specific role. However, there has not been fully studies
      regarding it. Thus, the investigators aimed to evaluate the impact of the posterior epidural
      fat on the postoperative outcomes such as pain intensity and functional outcomes by whether
      the epidural fat would be resected or not during posterior decompressive surgery. The
      investigators hypothesized that the epidural fat would be associated with postoperative pain
      intensitive, functional outcomes, and complications of the surgery such as failed back
      surgery syndrome. In this study, new device for resection of epidural fat was not utilized,
      but just resected with conventional devices such as pituitary forcep.
    


Intervention name(s): Resection of epidural fat; No resection of epidural fat
Intervention type(s): Procedure; Procedure
Intervention description(s): During surgical procedure, the epidural fat with pituitary forcep and rongeur was resected.; During surgical procedure, the epidural fat with pituitary forcep and rongeur was not resected.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: epidural fat; resection; spinal stenosis; lumbar spine
Contralateral Isokinetic Training on Strength and Reaching Skill
Condition: Hemiplegic Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The study aimed to ascertain how cross-education affected the activity of the paretic muscles
      in the upper limb and how that affected function in children with spastic hemiplegia and
      cerebral palsy. Additionally, it sought to determine how unilateral isokinetic resistance
      training affected children with spastic hemiplegia of the contralateral limb in terms of
      strength development.
    


Intervention name(s): Physical therapy exercises; Isokinetic training
Intervention type(s): Other; Other
Intervention description(s): For two consecutive months, the children in control group underwent a physiotherapy program for 60min/ three sessions each week: it was based mainly on the neurodevelopment technique, directed toward inhibiting abnormal muscle tone facilitating normal patterns of postural control and hand functions training program; Children in study group received the same program given to control group (A) in addition to isokinetic resistance training of the less affected upper limb for shoulder abductors in concentric mode at the angular velocity of 180 degree/ second under full supervision on the Biodex isokinetic dynamometer three times per week for 8 weeks, making a total of 24 training sessions. Each child was trained in the seated position with the similar precaution of the testing protocol.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Effects of Suvorexant in Participants With Obstructive Sleep Apnea (MK-4305-036)
Condition: Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, tolerability, and effect of multiple doses of suvorexant
      (MK-4305) on respiratory function in participants with mild to moderate obstructive sleep
      apnea (OSA) compared to administration of placebo. The primary hypothesis of this study is
      that multiple doses of MK-4305 do not produce a clinically significant increase in
      Apnea-Hypopnea Index (AHI) in participants with mild to moderate OSA, as compared to placebo.
    


Intervention name(s): Suvorexant; Matching Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40 mg tablets, orally once daily for 4 consecutive days in the evening; Placebo tablets, orally once daily for 4 consecutive days in the evening
Other intervention name(s): MK-4305; SCH 900433
Intervention MeSH terms: Suvorexant
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Insomnia; obstructive sleep apnea; orexin receptor antagonist