bioihbjkbjnl/mcl2 huggingface dataset:
Phase 1 Study on the Safety and Reactogenicity of a Single Dose of Monovalent High-dose Inactivated Poliovirus Type 2 Vaccine (m-IPV2 HD) Given Intramuscularly Compared to Standard Trivalent Inactivated Poliovirus Vaccine (IPV) in Healthy Adults
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate if the study vaccine, m-IPV2 HD (vaccine that
      only contains polio serotype 2 in high dose), is as safe as the standard IPV Imovax (that
      contains the 3 serotypes of polio). This safety evaluation will be done in young adults.

      If the study vaccine appears to be safe, it will be tested at a later stage in the target
      group (infants and children) to evaluate the immunogenicity of the vaccine. After all, the
      purpose is to use the study vaccine in the future to protect young children against Polio
      serotype 2. Disease with Polio type 2 indeed recently re-appeared, so vaccination of young
      children to come to a complete eradication of Polio is needed. The standard use of Imovax to
      protect against Polio serotype 2 would be too expensive. Therefore, a monovalent Polio
      vaccine containing only serotype 2 (= the vaccine that will be evaluated in this study), has
      been developed.

      The duration of the study will be approximately 6 months. 120 subjects between 18 and 45
      years of age will participate in Belgium.

      During the study there will be 2 groups of subjects. Subjects will be assigned by chance to
      one of these groups. One group will receive one single injection of the study vaccine m-IPV2
      HD (which contains only serotype 2), the other group will receive one single injection of the
      standard polio vaccine IPV, Imovax (which contains the 3 serotypes).

      After this vaccination, there will be a follow-up period of 6 months. Subjects will be asked
      to come to the study centre one more time for the second visit (on Day 8, which is 7 days
      after the first visit). They will also receive 2 follow-up phone calls for approximately one
      month and 6 months after vaccination.
    


Intervention name(s): a single dose of monovalent high-dose inactivated poliovirus type 2 vaccine (m-IPV2 HD); a single dose of the standard trivalent inactivated poliovirus vaccine (IPV)(Imovax Polio®).
Intervention type(s): Biological; Biological
Intervention description(s): a single dose m-IPV2 HD (study vaccine), 0,5ml; a single 0.5 ml dose Imovax Polio (control vaccine)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Poliomyelitis; Vaccine
Study to Compare Oxymorphone Extended-Release (Opana ER) Versus Oxycodone Controlled-Release (Oxycontin)
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the subjective and objective effects of Oxymorphone
      ER (Opana ER) versus Oxycodone CR (Oxycontin).
    


Intervention name(s): Oxymorphone ER; Oxycodone CR; Placebo; Hydromorphone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 15mg or 30mg; 30mg or 60mg; The placebo was a sugar pill.; 8 mg
Other intervention name(s): Opana; Oxycontin
Intervention MeSH terms: Oxymorphone; Oxycodone; Hydromorphone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Opioid; Recreational; Oxymorphone; Oxycodone; Extended Release; Healthy NonDependent Recreational Opioid Users
Evaluation of Heart Rate Variability in Third Lower Molars Surgeries
Condition: Healthy Patients
Study type: Observational

Summary: 
      The purpose of this study is to use heart rate variability as a monitor of cardiovascular
      safety during third molar surgeries, using the Polar heart rate-meter.
    


Intervention name(s): Use the Polar Cardiac rate meter
Intervention type(s): Device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        30 patients from the community sample in Dentistry School - University of Sao Paulo
      
Keywords: ASA I patients
Drotaverine Hydrochloride Versus Hyoscine-N-butylbromide for Duodenal Antimotility During Endoscopic Retrograde Cholangiopancreatography (ERCP)
Condition: ERCP; Pancreatic Diseases; Bile Duct Diseases
MeSH terms: Pancreatic Diseases; Bile Duct Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the present study was to evaluate the use of drotaverine hydrochloride versus
      hyoscine-N-butylbromide in reducing duodenal motility during diagnostic and therapeutic ERCP.
    

Detailed description: 
      ERCP is an important endoscopic technique in the diagnosis and treatment of pancreatic and
      biliary diseases. Duodenal peristalsis can make cannulation of the papilla and the necessary
      therapeutic procedures difficult. Intravenous hyoscine-N-butylbromide is often used during
      ERCP to inhibit duodenal motility and enhance cannulation in China. However, the
      pharmaceutical agent is occasionally associated with serious complications such as
      cardiovascular events or anaphylactic shock. Hyoscine-N-butylbromide may also affect the
      ocular, urinary, and salivary systems.

      Drotaverine hydrochloride is an analogue of papaverine with smooth muscle relaxant
      properties. It is a non-anticholinergic antispasmodic, which selectively inhibits
      phosphodiesterase IV and is accompanied by a mild calcium channel-blocking effect. Adverse
      effects with drotaverine hydrochloride, such as hypotension, vertigo, nausea, and
      palpitation, are mostly mild. It can be supposed that intravenous drotaverine hydrochloride
      might be a feasible antimotility alternative to intravenous hyoscine-N-butylbromide in ERCP.
      But there is no clear evidence to recommend the use of drotaverine hydrochloride as an
      antispasmodic during ERCP.

      The aim of the present study was to evaluate the use of drotaverine hydrochloride versus
      hyoscine-N-butylbromide in reducing duodenal motility during diagnostic and therapeutic ERCP.
      The effects of drotaverine hydrochloride on facilitative cannulation and its adverse effects
      were also compared to hyoscine-N-butylbromide.
    

Intervention name(s): Drotaverine hydrochloride; Hyoscine-N-butylbromide
Intervention type(s): Drug; Drug
Intervention description(s): Drotaverine hydrochloride 40mg was administered intravenously 15 minutes before ERCP; Hyoscine-N-butylbromide 20mg was administered intravenously 15 minutes before ERCP.
Other intervention name(s): No-spa; Scopolamine Butylbromide
Intervention MeSH terms: Drotaverin; Scopolamine; Butylscopolammonium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: ERCP; Drotaverine hydrochloride; Hyoscine-N-butylbromide
Vascular Effects of Dietary Potassium
Condition: Cardiovascular Risk Factor
Study type: Interventional

Summary: 
      The purpose of this study is to determine if dietary potassium can attenuate the deleterious
      effects of high sodium on blood vessel function in healthy, salt-resistant participants.
    

Detailed description: 
      Cardiovascular disease remains a major Public Health problem in the U.S. and is the result of
      diseases such as atherosclerosis and high blood pressure (BP). Several dietary factors have
      been implicated as risk factors including high sodium and low potassium diets. Indeed, it is
      well known that excess sodium can increase BP while potassium rich diets have BP lowering
      properties. While the role of these two nutrients on BP is widely accepted, their impact on
      the vasculature has received less attention. Endothelial dysfunction, characterized by
      impaired dilation is an important non-traditional risk factor for atherosclerosis. Data in
      animal models suggest that salt loading, independent of changes in BP, results in endothelial
      dysfunction while evidence is mounting that potassium may be beneficial to vascular health.
      Further, potassium may be more effective in the presence of high sodium however the role of
      potassium in protecting the vasculature from a high sodium diet in salt-resistant adults has
      not been explored. A potential mechanism responsible for sodium induced vascular dysfunction
      is overproduction of reactive oxygen species resulting in reduced nitric oxide (NO)
      production/ bioavailability. It has been suggested that potassium can counteract sodium's
      effect by reducing ROS. The central hypothesis is that potassium can protect against the
      deleterious effects of high sodium on the vasculature by reducing oxidative stress and
      preserving NO. In this grant, the investigators propose to use a 21-day controlled feeding
      study to compare the effects of a high sodium diet (300 mmol) combined with either a high
      (120 mmol) or moderate (65 mmol) amount of potassium and low sodium (50 mmol) combined with
      moderate potassium (crossover design, diet order sequence randomized) on 2 levels of the
      vasculature, conduit artery and microvasculature. These experiments will be performed in
      salt-resistant participants to study the vascular effects alone, independent of changes in
      BP.
    

Intervention name(s): Moderate Potassium/Low Sodium Diet; Moderate Potassium/High Sodium Diet; High Potassium/High Sodium Diet
Intervention type(s): Other; Other; Other
Intervention description(s): 7 days of the prescribed diet; 7 days of the prescribed diet; 7 days of the prescribed diet
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: All participants will complete each arm. It is a crossover, randomized design.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Potassium; Sodium; Vascular function
Prone Positioning in Non-intubated Patients With COVID-19 Associated Acute Respiratory Failure
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      Besides protective ventilation with low tidal volumes, prone positioning is a proven
      intervention to decrease mortality in mechanically ventilated patients with moderate-severe
      acute respiratory distress syndrome. However, the evidence of this strategy in awake
      non-intubated patients is scarce. The investigators will perform a randomized controlled
      trial to define if prone positioning can reduce the requirement of mechanical ventilation.
    

Detailed description: 
      Despite ongoing trials of antivirals and immunomodulatory therapies against COVID-19, the
      treatment of moderate/severe disease is mainly supportive, including oxygen therapy and
      invasive mechanical ventilation when impending respiratory failure is established. Moreover,
      the associated mortality among mechanically intubated patients is overwhelmingly high. Prone
      position relieves the dependent lung regions from the compressive forces of the mediastinum's
      weight, leading to homogenization of the gas:tissue ratio between ventral and dorsal lung
      regions. According to a few case series, and observational non-randomized studies with small
      sample sizes, there is a consistent improvement in oxygenation in COVID-19 patients during
      prone positioning, however there are no clinical evidence that this improvement is associated
      with a decrease in the risk of invasive mechanical ventilation. Considering that prone
      positioning is a low cost, low risk and widely available therapy, more high quality evidence
      is needed, to determine if the benefits of prone positioning in awake patients also include a
      lower requirement of mechanical ventilation.
    

Intervention name(s): Awake prone positioning; Standard oxygen therapy
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients will be asked to remain in prone position or lateral decubitus throughout the day as long as possible.; Oxygen therapy through high flow nasal cannula (HFNC). Inspired fraction of oxygen will be titrated to maintain a capillary saturation of ≥92%
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID-19; Severe; Prone positioning; High-flow nasal cannula
A First-in-Human Study of SBP-9330 in Healthy Subjects
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, first-in-human, randomized, double-blind, placebo-controlled,
      Single-Ascending Dose (SAD) / Multiple-Ascending Dose (MAD) study incorporating a food-effect
      cohort.
    


Intervention name(s): SBP-9330; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SBP-9330 oral capsules; Placebo oral capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Nasal Calcitonin in the Treatment of Bone Mineral Loss in Children and Adolescents With Inflammatory Bowel Disease
Condition: Ulcerative Colitis; Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional

Summary: 
      The hypothesis underlying this study is that nasally administered calcitonin will stabilize
      or improve bone mineral density in young patients with ulcerative colitis or Crohn's disease.
      Patients who participate will receive either calcitonin or placebo and will have their bone
      mineral density measured at the start, at nine months, and at 18 months of study.
      Participants will also receive age appropriate doses of vitamin D and calcium supplements.
      Other serological measures of vitamin D status will be obtained every 3 months during the
      study.
    

Detailed description: 
      This is an institutional, randomized, placebo-controlled, double-blind clinical trial to
      compare the efficacy of intranasally administered calcitonin (plus oral supplements of
      age-appropriate doses of calcium and vitamin D) with that of placebo nasal spray (plus oral
      supplements of age-appropriate doses of calcium and vitamin D) in maintaining or improving
      bone mineral density. Study subjects will be 8 to 22 year old patients with the diagnosis of
      inflammatory bowel disease (ulcerative colitis and Crohn's disease) and low bone mineral
      density defined as DXA z score lower than -1.0 SD. Study end-point will be at 18 months after
      the continuous administration of nasal calcitonin or placebo and supplements as above. Bone
      mineral density will be measured by dual energy X-Ray absorptiometry (DXA) at the beginning
      of the study, and then at 9 and 18 months. The study subjects will be evaluated clinically
      and nutritionally at the beginning of the study, as well as every 3 months for the duration
      of the study. Laboratory values relevant to calcium homeostasis and bone turnover will be
      obtained every 3 months.
    

Intervention name(s): Calcitonin nasal spray (salmon)
Intervention type(s): Drug
Intervention MeSH terms: Calcitonin; Salmon calcitonin; Calcitonin Gene-Related Peptide; Katacalcin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Keywords: bone mineral density; osteoporosis; osteopenia; children; adolescents; DXA
Pain Assessment During Mandibular Nerve Block Injection With the Aid of Dental Vibe Tool in Pediatric Dental Patients
Condition: Anesthesia, Local
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to valuate the effectiveness of DentalVibe(DV) tool in pain
      reduction during local anesthetic injection compared to traditional injection without aid of
      DentalVibe in pediatric patients.
    

Detailed description: 
      This study is a crossover randomized controlled clinical trial where (N=60 ) children will be
      selected from the outpatient clinic of Pediatric Dentistry and Public Health Department,
      Faculty of Dentistry, Alexandria University after securing necessary consents. These children
      will be selected based on a need for local anesthesia for pulpotomy treatment on both sides
      of the mandible. All selected children will be randomly allocated into 2 groups. Group I
      (assigned to injection with the aid of DentalVibe tool), Group II(assigned to conventional
      injection). Each group will receive 2 mandibular nerve block injections with two different
      injection techniques, with 1-2 weeks apart as a washing out period. Mandibular nerve block
      injection will be either with vibration using DentalVibe at the injection side or topical
      analgesic (benzocaine 20%) gel will be applied before the injection of local anesthesia at
      first the appointment, and the alternative technique will be used at the second appointment .
      Injection with the aid of DentalVibe tool will act as the experimental group while the
      control group will be the use of topical analgesic (benzocaine 20%).
    

Intervention name(s): DentalVibe; Topical Benzocaine 20%
Intervention type(s): Device; Drug
Intervention description(s): It is a vibrotactile device that aids in reducing pain during local anesthesia injection in pediatric patients; Topical benzocaine 20% gel on the mucosal injection site prior to injection
Intervention MeSH terms: Benzocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Each group will receive 2 mandibular nerve block injections with two different injection techniques, with 1-2 weeks apart as a washing out period .Mandibular nerve block injection will be either with vibration using DentalVibe at the injection side or topical analgesic (benzocaine 20%) gel will be applied before the injection of local anesthesia at first the appointment, and the alternative technique will be used at the second appointment. Injection with the aid of DentalVibe tool will act as the experimental group while the control group will be the use of topical analgesic (benzocaine 20%).
Masking: None (Open Label)
Primary purpose: Other
Keywords: DentalVibe; Mandibular nerve block injection; Consolability Scale
Coaching Intervention in Women At-risk for Common Mental Disorders
Condition: Common Mental Disorders
MeSH terms: Mental Disorders; Psychotic Disorders
Study type: Interventional

Summary: 
      This study aims to provide coaching intervention for prevention of developing common mental
      disorders to 60 at-risk women in Hong Kong.
    

Detailed description: 
      Participants will be recruited through online screening tool. Eligible subjects with informed
      consent provided will be randomly assigned to coaching group or self-help tips plus telephone
      support group.

      To test the effectiveness of the coaching intervention, data collection will be conducted on
      demographics, symptoms and psychosocial aspects at baseline, immediately, 3-month and
      12-month post-intervention. A self-reported brief questionnaire will be administered at every
      intervention as well.
    

Intervention name(s): Coaching; Self-help tips plus telephone support
Intervention type(s): Other; Other
Intervention description(s): Participants will receive 4 sessions of group coaching intervention within 6 weeks. Each session is in a group of 3-4 women and lasts for approximately 1.5 hours. The sessions will be conducted by experienced social workers.; Participants will receive 4 self-help tips sent via SMS and 4 phone call from a social worker in 6-week of time. During the telephone call, the social worker will advise the client to make use of the tips we sent to her.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Predictive Score Identifies Patients With Inadequate Bowel Preparation for Colonoscopy
Condition: Bowel Preparation; Ottawa Score
Study type: Observational [Patient Registry]

Summary: 
      Colonoscopy is the current standard method for evaluating the colorectal diseases. Adequate
      bowel preparation is essential for optimal visualization of the colorectal mucosa. However,
      inadequate bowel preparation (IBP) had been unexpectedly reported in up to 30% of patients
      undergoing colonoscopy. Many factors may influence the quality of bowel preparation, which
      can be broadly categorized as patient-related or procedure-related. It has been shown that
      split-dose regimen or some modified educational strategies can improve the quality of bowel
      preparation. For the patients with possible IBP before the performing of colonoscopy, it may
      be better to repeat bowel preparation with modified or enhanced strategies in case of failed
      intubation, missed lesions or unnecessarily increased cost. Thus, it is important to set up a
      model to predict the quality of bowel preparation individually.
    


Intervention name(s): Bowel preparation instructions
Intervention type(s): Other
Intervention description(s): The same-day preparation method was used as previously reported. Briefly, all patients were instructed to have a regular diet for breakfast and lunch, but only clear liquids for dinner on the day before the colonoscopy. They were asked to drink two bags of PEG-ELP (polyethylene glycol electrolyte powder) dissolved in 2 L of water, or 45 mL of sodium phosphate be diluted in 240 mL of cool water follow with at least 1.5 L of water at 05:00-06:00 h within 2 h on the day of colonoscopy. Patients were encouraged to drink more clear liquids after purgatives for adequate hydration before colonoscopy.
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This is a prospective study involving two tertiary centers in China. The patients of the
        training cohort were enrolled from the Endoscopy Center of Xijing Hospital of Digestive
        Diseases in China. The patients of the validation cohort were enrolled from the Shaanxi
        Second People's Hospital in China.
      
Keywords: bowel preparation; Ottawa Score
Treatment of Knee Osteoarthritis With Autologous Mesenchymal Stromal Cell Product (RegStem)
Condition: Osteoarthritis,Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      Osteoarthritis (OA) is a common and incurable disease for the elderly in Taiwan, so it is an
      important mission to develop a new treatment for OA. Recently, cellular therapy is a new and
      popular medical treatment around the world, one of them is "Mesenchymal Stromal Cells
      (MSCs)". MSCs are found in many tissues of human body and play an important role for
      repairing, regeneration, anti-inflammatory and chondrogenesis. So, MSC product, RegStem, for
      osteoarthritis treatment becomes a developing target for new generation drugs.

      This study is to isolate and expand MSCs(RegStem) from infrapatellar fat pad of subject. When
      the number of MSCs expands to 1×10^8, cell will be cryopreserved in the liquid nitrogen tank
      until all release tests passed. On the distribution day, cell will be thawed and injected
      into joint cavity of patient (5×10^7). Subjects will be monitored after MSC product infusion
      of seven days, one month, six months and one year. The monitoring items include the changes
      of knee (by appearance, X-ray and MRI of knee) and pain improvement (by questionnaire).
    


Intervention name(s): RegStem
Intervention type(s): Biological
Intervention description(s): RegStem, 1.5 ml, one injection
Other intervention name(s): MSC
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment