bioihbjkbjnl/mcl2 huggingface dataset:
Specific Carbohydrate Diet for Clostridium Difficile
Condition: Clostridium Difficile Infection; Diet Modification
MeSH terms: Clostridium Infections
Study type: Interventional

Summary: 
      The investigators are doing this research study to answer questions about a nutritional
      therapy called the Specific Carbohydrate Diet (SCD) for children with active Clostridium
      Difficile Infection.

      For this study, the investigators will be looking to determine:

        1. Is SCD effective for the treatment for Clostridium Difficile Colonization?

        2. Is the SCD well tolerated?
    

Detailed description: 
      The aim of this study is to determine the tolerability and potential efficacy of dietary
      therapy, the Specific Carbohydrate Diet (SCD), in pediatric patients with persistent antigen
      positivity due to C. difficile colonization with minimally active symptomatology. The goal of
      this pilot study is to gather preliminary data for a future treatment controlled trial of SCD
      versus standard medical therapy.

      This is a single center, open labelled study designed to determine tolerability, preliminary
      safety and potential efficacy in pediatric patients with persistent C. difficile colonization
      with minimally active symptomatology. The study patients will be recruited from Seattle
      Children's Gastroenterology and Infectious Disease clinic.
    

Intervention name(s): Specific Carbohydrate Diet
Intervention type(s): Dietary Supplement
Intervention description(s): The diet removes all grains such as wheat, barley, corn, rice, and most dairy products (except yogurt fermented for 24 hours and cheese aged for grater than 30 days). The diet mainly consists of meat, fruits, vegetables, nuts, oils, and honey.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Specific Carbohydrate Diet; Clostridium Difficile Infection; Clostridium Difficile; cDiff; Diet
SATIN The Acute Effect of Orange Nectar With NAXUS Fibre Made by Novel Processing on Satiety and Satiation
Condition: Appetite
Study type: Interventional

Summary: 
      A 4 week double blinded parallel design with an intervention condition and a control
      condition will be employed. After having completed screening procedure and a baseline test
      day, participants will be randomized to either intervention or control condition. In the
      following 4 weeks, the participants will have to consume the distributed food product daily
      before completing another test day.
    


Intervention name(s): Orange nectar; Orange Nectar with fibre
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Orange nectar
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Ad libitum energy intake; Appetite sensation
Staccato Prochlorperazine in Migraine (in Clinic)
Condition: Migraine Headache, With or Without Aura
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 2

Summary: 
      Development of Staccato Prochlorperazine for the treatment of migraine headache.
    


Intervention name(s): Staccato Placebo; Staccato Prochlorperazine 5 mg; Staccato Prochlorperazine 10 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Inhaled Staccato Placebo; Inhaled Prochlorperazine 5 mg; Inhaled Prochlorperazine10 mg
Intervention MeSH terms: Prochlorperazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Migraine, Staccato Prochlorperazine; Migraine headache with or without aura.
A Study to Assess if Epanutin Infatabs 50 mg From Germany Are Similar to Dilantin Infatabs 50 mg From Australia
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study, the bioequivalence of Epanutin Infatabs® 50 mg (sourced from Germany) and
      Dilantin Infatabs® 50 mg (sourced from Australia) will be assessed. This is intended to be a
      pivotal bioequivalence study.
    


Intervention name(s): Epanutin Infatabs (Phenytoin); Dilantin Infatabs (Phenytoin)
Intervention type(s): Drug; Drug
Intervention description(s): Chewable Tablet, 50 mg, Single dose; Chewable Tablet, 50 mg, Single dose
Intervention MeSH terms: Phenytoin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: phenytoin; chewable tablets; dilantin; epanutin; infatabs; bioequivalence; Partial seizure; Tonic-clonic seizure
18F-FDG PET/CT in Diagnostic Patients of Disorder of Consciousness
Condition: Persistent Vegetative State
MeSH terms: Consciousness Disorders; Persistent Vegetative State
Study type: Interventional

Summary: 
      Clinical examinations are difficult to discriminate between vegetative state and minimally
      conscious state. the diagnostic and prognostic usefulness of neuroimaging methods has not
      been established in a clinical setting. we will do a forward study of PET imaging in
      disorders of consciousness patients, and validate with clinical assessments with the coma
      recovery Scale-Revised(CRS-R).
    

Detailed description: 
      Every patient need to be conducted the PET/CT scanning two times.The first time is resting
      state.The second time is stimulated state by watching a vedio.
    

Intervention name(s): 18F-FDG
Intervention type(s): Radiation
Intervention description(s): 18F-FDG is positron emission tomography imaging agent which is already widely used in PET/CT examination.
Intervention MeSH terms: Fluorodeoxyglucose F18
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Immunogenicity of Co-administered Yellow Fever and Measles, Mumps, and Rubella (MMR) Vaccines
Condition: Vaccine Response Impaired
MeSH terms: Rubella; Yellow Fever
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates seroconversion against measles, mumps, rubella and yellow fever
      following vaccination. One-third of children will receive both yellow fever and measles,
      mumps, and rubella (MMR) vaccines on the same day; one- third of children will receive MMR
      vaccine at enrollment followed by yellow fever vaccine 4 weeks later; one-third of children
      will receive yellow fever vaccine at enrollment followed by MMR vaccine 4 weeks later.
    

Detailed description: 
      The World Health Organization (WHO) and the Pan American Health Organization recommend that
      yellow fever and measles, mumps and rubella (MMR) vaccines be administered on the same day or
      at least 4 weeks apart to prevent interference between live vaccines. In 2011 a Brazilian
      study demonstrated lower seroconversion against yellow fever, rubella, and mumps when the two
      vaccines were administered on the same day compared with administering them separately. WHO
      urged that additional studies be conducted to examine this issue.

      This Phase IV study aims to determine if seroconversion against measles, mumps, rubella, and
      yellow fever after administration of MMR and yellow fever vaccines on the same day is
      non-inferior to seroconversion after sequential administration 28 days apart in health
      12-month old children.
    

Intervention name(s): Co-administration of MMR/YF; MMR followed by YF; YF followed by MMR
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Both MMR & yellow fever vaccines administered on Day 0.; MMR vaccine administered on Day 0 and yellow fever vaccine administered on Day 28.; Yellow fever vaccine administered on Day 0 and MMR vaccine administered on Day 28.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: yellow fever vaccine; MMR vaccine; immunogenicity
Amitiza in Constipation Associated With PD (Parkinson's Disease)
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease; Constipation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if Amitiza (lubiprostone), a drug proven to be safe
      and effective for chronic constipation, will also improve constipation symptoms in
      Parkinson's Disease patients. We will also evaluate the impact of the drug on changes in
      bowel movement consistency, quality of life and motor symptoms.
    

Detailed description: 
      Parkinson's disease (PD) affects about one million people in the United States. It is a
      common neurological condition that is clinically defined by rigidity (muscle stiffness),
      bradykinesia (slowness of movement) and tremor. Parkinson's Disease , however, reveals
      numerous non-motor symptoms that have been underemphasized. Problematic symptoms include
      varying degrees of dementia, psychosis, diminished assertiveness and confidence, general
      fatigue, excessive daytime sleepiness, problems with blood pressure, sweating, and bladder,
      and a common yet difficult to define sense of "not feeling well".

      A commonly missed symptom in Parkinson's patients is constipation. Constipation can be
      difficult to treat with current medications available and many are ineffective. Levodopa and
      dopamine agonists drugs are useful for motor symptoms in Parkinson's Disease but have no
      effect on constipation. Laxatives and enemas provide limited relief with bothersome side
      effects. Even fewer drugs have been studied targeting the constipation problem specifically
      in the Parkinson's Disease population. Lubiprostone (AMITIZA) is a new medication that has
      been studied in the general population for the treatment of chronic constipation. It has been
      shown to be a safe and effective medication with few side effects. Lubiprostone has not yet
      been studied in the Parkinson's Disease population. We hope to show that this medication can
      be safe and effective for constipation in PD patients as well.
    

Intervention name(s): LUBIPROSTONE
Intervention type(s): Drug
Intervention description(s): Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
Intervention MeSH terms: Lubiprostone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: constipation; Parkinson's disease
Effect of Micro-osteoperforation on the Rate of Canine Retraction
Condition: Orthodontics
Study type: Interventional

Summary: 
      The current study Is a split-mouth Randomized Controlled Trial that was performed to
      investigate three dimensionally, using digital models and Cone Beam Computed Tomography
      imaging, the effect of micro-osteoperforations (MOPs) on the rate of tooth movement in a
      canine retraction model.
    

Detailed description: 
      Sample size calculation was carried out and resulted in enrolment of 18 female patients
      requiring bilateral upper first premolars extraction and canine retraction with maximum
      anchorage. The sample was recruited from the outpatient clinic of the Orthodontic Department,
      Faculty of Dentistry, Cairo University.

      After placement of the fixed orthodontic appliance, leveling and alignment proceeded till
      0.016" × 0.022" NiTi upper archwire. Indirect skeletal anchorage was then prepared using TADs
      inserted bilaterally between the upper 1st molar and 2nd premolar, and the patient was
      referred for upper 1st premolars extraction.

      Three months after extraction, 0.017" × 0.025" stainless-steel upper archwire was inserted
      and three vertically aligned MOPs were randomly allocated and performed in one side using a
      single TAD, while the other side served as control. The three MOPs were performed distal to
      the canine, equidistant in the extraction space. Bilateral canine retraction was then
      commenced using NiTi closing coil springs delivering 150 gms of force. Before leaving the
      clinic, a pain questionnaire was given to each patient.

      Data were collected from monthly upper impressions, which were poured into stone models and
      scanned to obtain sequential digital models (T0, T1, T2, T3 & T4), in addition to pre- and
      post-retraction maxillary CBCT images.

      The assessed outcomes were the rate of canine retraction per month, the total distance
      travelled by the upper canines, first molars anchorage loss, tipping, torque and rotation of
      upper canines and first molars, canine root resorption and finally the pain related to MOP
      procedure. Statistical analysis was performed on the gathered data and results were
      withdrawn.
    

Intervention name(s): micro-osteoperforation
Intervention type(s): Procedure
Intervention description(s): Minor surgical procedure including performance of limited and shallow perforations of the cortical plate of bone to increase the expression of inflammatory cytokines, hence accelerating orthodontic tooth movement.
Other intervention name(s): alveolocentesis; bone puncturing; flapless corticotomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Open-label, Single-dose Trial to Assess the Pharmacokinetics of Centanafadine Extended-release Capsules in Pediatric Participants With Attention-deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      With the pharmacokinetics (PK) of centanafadine currently being evaluated in adults. The PK
      of extended-release centanafadine may differ in children compared to adults due to
      physiological differences in the gastrointestinal tract. The information in this trial will
      support pediatric dose selection in future trials.
    


Intervention name(s): Centanafadine
Intervention type(s): Drug
Intervention description(s): Extended-release and immediate-release capsules.
Other intervention name(s): EB-1020
Intervention model: Single Group Assignment
Intervention model description: All the participants received only centanafadine but divided into 2 arm groups based on administration (as capsules or drug sprinkled onto applesauce).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD
Upright Back Posture Device Study
Condition: Back Pain; Postural Low Back Pain; Lower Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This is a randomized controlled study to determine if patients between the ages of 18-50
      years, with posture related low back pain, who use the Upright device demonstrate improved
      pain control and self perception of posture compared to those given standard ergonomic
      instruction.
    

Detailed description: 
      Back pain is a common complaint among students. For many, back pain is directly related to
      poor posture while sitting and standing. Those who spend prolonged time sitting in poor
      posture often develop muscular imbalances leading to tight chest muscles and weakness in back
      muscles. The Upright system is a device which helps provide a sensory reminder to alert users
      when their posture is poor. The purpose of this study is to determine if patients who use the
      upright posture device demonstrate improved pain control and self perception of posture when
      compared to those given standard ergonomic instruction.
    

Intervention name(s): Upright Go Device; Ergonomic Handout
Intervention type(s): Device; Other
Intervention description(s): Participants will be asked to use the Upright device everyday for four (4) weeks. After four (4) weeks, the participants will be asked to complete a couple of questionnaires regarding their pain scale and back posture.; Participants will be asked to use the ergonomic handout everyday for four (4) weeks. After four (4) weeks, the participants will be asked to complete a couple of questionnaires regarding their pain scale and back posture.
Other intervention name(s): Upright Technologies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Upright; Back; Posture; Back pain
Liposomal Bupivacaine vs Dexamethasone ISB
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study, patients receiving shoulder arthroscopy will receive an interscalene block for
      pain management containing either liposomal bupivacaine and standard bupivacaine or standard
      bupivacaine and dexamethasone. Patients will be followed up with to determine postoperative
      pain and block duration.
    


Intervention name(s): Exparel 133 MG Per 10 ML Injection; Dexamethasone
Intervention type(s): Drug; Drug
Intervention description(s): 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total); 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected
Other intervention name(s): Liposomal Bupivacaine
Intervention MeSH terms: Dexamethasone; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Whey Protein on Blood Pressure
Condition: High Blood Pressure
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The purpose of this study is to determine if consumption of whey protein, compared with soy
      protein or a carbohydrate food decreases blood pressure along with reducing risk factors for
      heart disease.
    

Detailed description: 
      Several lines of evidence suggest that consumption of dairy foods, and specifically whey
      protein, may reduce blood pressure. This proposed study is designed investigate the effect of
      whey protein compared to another protein source.

      Since blood pressure is a recognized risk factor for cardiovascular disease, if there is
      clear evidence that whey protein reduces blood pressure, dietary recommendations may be made
      regarding whey protein intake. However, dietary recommendations to consume whey protein as a
      means to improve health status must be science-based. Results from this study will provide a
      scientific basis for dietary recommendations regarding whey protein intake.
    

Intervention name(s): Whey Protein; Soy Protein; Control (carbohydrate)
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 40 grams per day Whey Protein; 40 grams per day soy protein; 40 grams per day maltodextrin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: hypertension; prehypertension; high blood pressure; blood pressure; heart disease
Prospective Comparison of Cold Polypectomy and Conventional Polypectomy for Small Colorectal Polyps in Patients Taking Antithrombotic Agents
Condition: Colorectal Polyps
MeSH terms: Polyps
Study type: Interventional

Summary: 
      1. Background: The ideal method to remove small colorectal polyps in patients who are
           taking antithrombotic agents is unknown.

        2. Aim: The aim of this study is to evaluate postpolypectomy bleeding and the complete
           retrieval rate after the removal by colon snare transection without electrocautery for
           small polyps in patients who are taking antithrombotic agents.

        3. Design: A prospective, consecutive study.

        4. Setting: Municipal hospital outpatients.

        5. Interventions: Polypectomy by cold snare technique (Cold polypectomy) was performed for
           colorectal polyps up to 10 mm in diameter in patients who continue to take
           antithrombotic agents. The primary outcome measure was bleeding within two weeks after
           polypectomy. Secondary outcome measure was the complete retrieval rate of colorectal
           polyps based on the pathological examination.
    


Intervention name(s): Cold polypectomy
Intervention type(s): Procedure
Intervention description(s): All colorectal polyps up to 10 mm found except for tiny hyperplastic polyps in the rectum and distal sigmoid colon are removed. The technique is cold resection of the polyp without tenting and then suction of the transected polyp into a trap followed by submission to histopathological evaluation.
Other intervention name(s): Cold snare polypectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: 10 mm in diameter; antithrombotic agents
Pilot Study for the Evaluation of the Efficacy of Vaccination With Autologous Tumor Cells Plus Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) - in - Adjuvant, Followed by Systemic Low-dose-interleukin-2 (IL-2) Administration, in Patients With High Risk Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Study type: Interventional

Summary: 
      This study is an open-label, pilot study of an autologous tumor cell vaccine.
    

Detailed description: 
      Regimen: A vaccine comprising autologous melanoma cells plus GM-CSF in-adjuvant will be
      administered intradermally at a single dose. Subjects will be vaccinated over at least a 6
      week period (at weeks 0, 1, 2, 4, 5, 6), with responders vaccinated every 4 weeks thereafter
      for a maximum of 9 vaccinations (up to week 18). Systemic low-dose interleukin-2 will also be
      administered daily for 6 weeks following the second vaccination at week 1.

      Concurrent with the first three of these vaccinations, each patient will also receive an
      additional set of 3 vaccinations in a different site, the response to which will be evaluated
      at the draining lymph node. This node will be harvested using lymphatic mapping and sentinel
      node biopsy methods.
    

Intervention name(s): autologous tumor cells plus GM-CSF-in Adjuvant
Intervention type(s): Biological
Intervention description(s): Autologous tumor cells plus 225 ug GM-CSF in-adjuvant: The autologous tumor cells will be administered intradermally. Subjects will be vaccinated over at least a 6 week period (at weeks 0, 1, 2, 4, 5, 6), with responders vaccinated every 4 weeks thereafter for a maximum of 9 vaccinations (up to week 18). Systemic low-dose interleukin-2 will also be administered daily for 6 weeks following the second vaccination at week 1.
Concurrent with the first three of these vaccinations, each patient will also receive an additional set of 3 vaccinations in a different site, the response to which will be evaluated at the draining lymph node. This node will be harvested using lymphatic mapping and sentinel node biopsy methods.
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: melanoma; vaccine; IL2 low dose