bioihbjkbjnl/mcl2 huggingface dataset:
Study of KRN23 in Adults With X-linked Hypophosphatemia (XLH)
Condition: X-linked Hypophosphatemia
MeSH terms: Familial Hypophosphatemic Rickets; Hypophosphatemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary efficacy objective of this study is to establish the effect of burosumab
      treatment compared with placebo on increasing serum phosphorus levels in adults with XLH.
    


Intervention name(s): burosumab; Placebo
Intervention type(s): Biological; Other
Intervention description(s): solution for SC injection; saline solution for SC injection
Other intervention name(s): UX023; KRN23; Crysvita
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: KRN23; Fibroblast growth factor 23 (FGF23); XLH; X-linked hypophosphatemia; burosumab; Crysvita
Allium Sativum Extract as an Irrigant
Condition: Infected Root Canals of Primary Molars
Study type: Interventional

Summary: 
      Garlic extract as herbal compound has potent antibacterial properties and can be used safely
      as an irrigant for pulpectomy procedure of primary molars root canals with high clinical and
      radiographic outcomes
    

Detailed description: 
      Aim: This study indented to assess the clinical and radiographic assessment of garlic extract
      as an intracanal irrigant for pulpectomy of primary molars.

      Methodology: 91 child with 100 teeth submitted into this study were equally categorized into
      the test group (group 1) which irrigated with garlic extract and control group (group 2) that
      received sodium hypochlorite (NaOCl). Then, each group has been subjected to further
      specification according to the tooth preoperative clinical and radiographic features into has
      been into 2 subgroups. Clinical and radiographic success rates were checked at 3, 6 and 12
      months. Fisher's exact test for binary variable was used for data analysis with p-value ≤
      0.05.
    

Intervention name(s): Garlic extract; NaOCl (COLTENE®)
Intervention type(s): Other; Other
Intervention description(s): A 100 gram of garlic cloves has been cleaned, peeled and dried. Ethanol of 70% concentration was added for 60 seconds. The cloves were placed in a laminar airflow chamber for evaporation of residual ethanol. Using a sterile mortar and pestle, cloves were homogenized aseptically and filtered through a double layer paper. The fully concentrated extracted was diluted to the concentration of 25% with distilled water; Sodium hypochlorite
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Primary molars; Garlic extract; Sodium hypochlorite; Pulpectomy
Diagnostic of Lewy Body Dementia by Combining Scintigraphy (SPECT) Using a Specific Transporter and Magnetic Resonance Imaging (MRI)
Condition: Lewy Body Dementia
MeSH terms: Dementia; Lewy Body Disease
Study type: Interventional

Summary: 
      The aim of this study is to improve the diagnostic of Lewy body dementia by combining the
      scintigraphy (SPECT) usig a spécific transporter and magnetic resonance imaging (MRI).
    

Detailed description: 
      Lewy body dementia is the second leading cause of dementia in France after degenerative
      Alzheimer's disease.

      However its dignosis is difficult. Its comes in large part from the similarity of symptoms
      with another close dementia syndrome : the Alzheimer disease . Therfore, its is very
      important to have a mean to distinguish between the two dementias.

      One highlight of the Lewy body dementia process being dopaminergic degeneration, the use of
      specific radioactive tracers is thought to be the way. The radiotracer that has the greatest
      advantage for these explorations is currently the DaTSCAN because it binds specifically on
      the dopamine transporter and can be used in Single photon emission computed tomography
      (SPECT).

      The aim of this study is to improve the performance of imaging in the diagnosis of dementia
      by combining scintigraphy (SPECT) and magnetic resonance imaging (MRI) in the exploration of
      the striatal region . The development of this method applied to a population of subjects,
      with hallucinations and cognitive disorders, should demonstrate the value and complementarity
      of metabolic images (SPECT) and morphological (MRI) within the differential diagnosis of Lewy
      body dementia and the Alzheimer disease .

      From a methodological point of view, the patient will be included in hospital and will have a
      clinical diagnosis defined according to the criteria of dementia NINCDS-ADRDA for the
      Alzheimer disease and Mc-Keith criteria for Lewy body dementia. Their MMSE will be over 18
      and they have in common recurrent visual hallucinations.

      After the inclusion, two steps must be distinguished, a neuropsychological evaluation stage
      and an scitigraphy exploration . Before the SPECT , all patients should have an MRI.
    

Intervention name(s): Single photon emission computed tomography and Magnetic Resonance Imaging
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Primary purpose: Diagnostic
Modification of Goal-directed and Habitual Behavior in Addiction
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder; Behavior, Addictive
Study type: Interventional

Summary: 
      This study aims to examine the modification of the hypothesized imbalance between
      goal-directed and habitual behavior and its neural correlates in smokers. Two interventions
      will be used as add-on trainings to a smoking cessation program.
    

Detailed description: 
      In this study, the investigators aim to assess the imbalance between goal-directed and
      habitual behavior, its neural basis and how it can be differentially modified in
      treatment-seeking smokers, using two training interventions. The first intervention is
      cognitive remediation treatment (CRT), also known as cognitive enhancement therapy, focusing
      on improving inhibitory control and executive functions. The second intervention, a
      computer-based habit-modifying training focusing on implicit drug seeking ("implicit
      computer-based habit-modifying training", ICHT) uses a conditioning approach through implicit
      priming and contextual modulation. Indicators of the imbalance will be examined with respect
      to reward devaluation, cue reactivity and a pavlovian instrumental transfer (PIT) paradigm.
      The investigators hypothesize that both interventions change the balance between
      goal-directed and habitual behavior but by different mechanisms. Whereas CRT should directly
      increase cognitive control, in contrast, ICHT should affect the early processing and the
      emotional valence of smoking and smoking cues.
    

Intervention name(s): standard smoking cessation program (SCP); Cognitive remediation treatment (CRT); Implicit computer-based habit-modifying training (ICHT)
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Each subject will receive standard SCP as group treatment once a week (1 hour) over six weeks. This group therapy is based on behavioural therapy and a psycho-educational approach (for more details see Batra & Buchkremer 2004), and will be carried out by a qualified therapist.; Cognitive remediation treatment (CRT) employing a chess-based battery of tasks two times per week over six weeks as a group treatment in our outpatient clinic (60 min duration per session).; Implicit computer-based habit-modifying training (ICHT), applied twice a week for six weeks. In this training, the participants perform a two-part training. First, a subliminal presentation (20 ms) of negative valenced primes before smoking-cues in context and secondly, a subliminal presentation of positive valenced primes before potentially reinforcing events.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Addiction; Nicotine; Smoking Cessation; Relapse; Craving; habitual behavior; cognitive remediation; implicit priming; pavlovian instrumental transfer
Effect of Cherry Concentrate on Brain Activation and Perfusion in Healthy Older Adults
Condition: Healthy
Study type: Interventional

Summary: 
      Effect of 8 weeks of cherry concentrate supplementation on cognitive function and brain
      perfusion in healthy older adults
    

Detailed description: 
      The investigators will perform a double blind, randomised controlled study to determine
      whether cherry polyphenols improve peripheral vascular function and cerebral perfusion
      resulting in improved task related brain activation and cognitive function. 30 healthy
      elderly men and women 60-85y years will be recruited to complete 8-week supplementation with
      MC concentrate or an isoenergetic cherry placebo concentrate. Participants will be pair
      matched for age, sex, and cognitive function (Adenbrooke's Cognitive Examination III,
      ACE-III) and then randomised using a sealed envelope system to receive either placebo or
      cherry.
    

Intervention name(s): Cherry concentrate; Placebo concentrate
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Safety and Efficacy of Herbal Tea in Type 2 Diabetics
Condition: Type 2 Diabetes; Herbal Medicine Adverse Reaction
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Nearly 25% of the world's population relies on traditional medicinal systems but for
      professionals their effectiveness and even more safety are the main concern. Therefore, the
      aim of this preliminary study is to assess safety and effectiveness of herbal tea mixture on
      the control of glycaemia in Type 2 diabetics.The mixture consists of nine plants which have
      well-documented traditional use for the control of glycaemia.
    

Detailed description: 
      The study will include Type 2 Diabetics who are taking only oral hypoglycemic medications
      (without insulin). Their therapy has to be stable for at least 3 months prior enrollment.
      Besides anthropometric measures, patient's glycaemia, renal and liver function will be
      monitored. Safety and adverse events will be closely monitored and these are the primary
      outcomes of the study. The main outcome measure of the effectiveness is HbA1c (glycated
      hemoglobin). Patients will be given detailed instructions on how to prepare the tea and the
      dosing. The intervention will last 3 months and during that time patients will be asked not
      to change their dietary or lifestyle habits.
    

Intervention name(s): Antidiabetic Herbal Tea; Herbal Tea
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Patients will be instructed to take 250 mL of freshly prepared tea (1 tea spoon or 3 g of tea, pour over 250 mL of boiling water and leave aside for 15 min) 2 times per day during 12 weeks. The first tea needs to be taken in the morning prior any meal. The second can be taken at any time during the day but with at least 4 hour difference from the first cup.; Patients will be instructed to take 250 mL of freshly prepared tea (1 tea spoon or 3 g of tea, pour over 250 mL of boiling water and leave aside for 15 min) 2 times per day during 12 weeks. The first tea needs to be taken in the morning prior any meal. The second can be taken at any time during the day but with at least 4 hour difference from the first cup.
Other intervention name(s): Experimental-Intervention; Active Comparator-Control
Intervention MeSH terms: Hypoglycemic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Screening
Keywords: Type 2 Diabetes; Herbal Medicine; Safety; Glycaemia Control; Alternative Therapy
PET Imaging in Cocaine Self Administration
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional

Summary: 
      There has been recent interest in the role of the 5-HT1B receptor as a possible modulating
      factor in cocaine dependence, certainly in preclinical models. The Yale Positron Emission
      Tomography (PET) Center has developed a novel 5-HT1B receptor antagonist radioligand,
      [11C]-P943, which has been validated in human studies. We hypothesize that the 5-HT1B
      receptor plays a key role in cocaine dependence. The long term goal of this project would be
      to study pharmacological manipulation of the 5-HT1B receptor as a potential molecular target
      for cocaine dependence.
    


Intervention name(s): [11C]-P943
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Impact of Bedtime Snacks on Glucose Control in Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Approximately 3 million Canadians have type 2 diabetes, a condition where the blood sugar
      levels are too high, uncontrolled blood sugars lead to cardiovascular disease and other
      complications. Patients with type 2 diabetes are often advised to consume a snack before bed
      in order to help control morning blood sugar levels. However, scientific evidence for this
      dietary approach is limited and there is no data to help elucidate what the ideal bedtime
      snack is. We hypothesize that a high protein, high fat snack with very little carbohydrate,
      will be an effective bedtime snack for lowering morning glucose without spiking glucose
      levels in the night. In this study we will determine if a bedtime snack that is high in
      protein and fat but low in carbohydrate can help improve morning glucose control in people
      with type 2 diabetes. This information will provide scientific evidence for the potential
      health benefits of strategically-timed high protein, high fat snack consumption in people
      with type 2 diabetes.
    

Detailed description: 
      Fifteen patients with physician diagnosed type 2 diabetes (HbA1c 6.5-9%), between the ages of
      30-80 years, and not on exogenous insulin therapy, will complete three, 3-day intervention
      periods (proof-of-concept randomized trial). Participants will consume a standardized diet
      for three days with either i) two hard-boiled eggs, ii) fruit yogurt; or iii) control
      no-bedtime snack, thirty minutes prior to bedtime. Fasting blood samples will be obtained on
      Day 4 in the morning after following each 3-day dietary intervention. Blood glucose will be
      monitored continuously across the intervention period using continuous glucose monitoring
      (CGM). CGM allows for the moment-to-moment changes in blood glucose to be examined for
      several days, allowing the unique opportunity to examine the glucose responses at different
      points of the day, including fasting hyperglycemia in the morning, nocturnal glucose, and
      postprandial glucose in response to meals. To our knowledge, CGM technology has never been
      used in a bedtime snacking study in type 2 diabetes.
    

Intervention name(s): Dietary
Intervention type(s): Other
Intervention description(s): Diet will be manipulated by providing different bedtime snacks within an otherwise isocaloric diet.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Targeting the Carotid Bodies to Reduce Disease Risk Along the Diabetes Continuum
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      Our overall goal is to advance our understanding of the contribution of the carotid body
      chemoreceptors in glucose regulation and the development of type 2 diabetes.
    


Intervention name(s): Hyperoxia Exposure; Normoxia Exposure
Intervention type(s): Other; Other
Intervention description(s): 2 hours of hyperoxia exposure during OGTT; 2 hours of normoxia exposure during OGTT
Intervention model: Single Group Assignment
Intervention model description: After screening, participants will complete two study visits.
Masking: None (Open Label)
Primary purpose: Basic Science
Engaging Families to Improve the Care of Patients With Hypospadias
Condition: Hypospadias
MeSH terms: Hypospadias
Study type: Interventional

Summary: 
      Reconstructive surgery is advocated for most children with hypospadias, a condition in which
      the pee hold is not in the correct place on the penis, to prevent potentially serious
      cosmetic and functional problems. Parents faced with a decision about hypospadias repair
      encounter an irreversible choice with potentially lifelong consequences. Recent studies have
      identified decisional conflict (DC) and decisional regret (DR) as a significant problem for
      parents. Several recent guidelines on complex urologic topics suggest that shared
      decision-making (SDM) is the optimal approach.

      A pilot test of a decision aid website by parents potentially facing this decision will be
      conducted to measure pre- and post-outcomes, in order to develop a fuller understanding of
      how urologists can effectively provide parents with optimal decision support. Parents will
      answer questions via phone up to four time points, twice before (T1 and T2) and twice after
      seeing a urologist for a hypospadias referral (T3 and T4). If the urologist diagnoses
      hypospadias but recommends no surgery, the final data collection point will be three months
      after the urology visit. If the urologist recommends repair surgery, the final data
      collection point will be six months after surgery.
    


Intervention name(s): Decision Aid Website
Intervention type(s): Other
Intervention description(s): The (private) decision aid website contains information in text, graphic, and video form about hypospadias and considerations for choosing surgery and no surgery.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: hypospadias; shared decision making; decisional regret; decision aid
Intervention and Mechanisms of Alanyl-Glutamine for Inflammation, Nutrition, and Enteropathy
Condition: Malnutrition; Environmental Enteropathy; Diarrhea
MeSH terms: Intestinal Diseases; Malnutrition; Inflammation; Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      Several host factors underlie the pathogenesis of the reciprocal cycle of childhood diarrhea
      and undernutrition in developing countries. These include intestinal inflammation, mucosal
      damage, and alterations in intestinal barrier function that lead to malabsorption, growth
      failure, and heightened susceptibility to recurrent and prolonged episodes of diarrhea.
      Recent studies from Northeast Brazil demonstrate the benefits of a novel
      alanyl-glutamine-based oral rehydration and nutrition therapy (Ala-Gln ORNT) in speeding the
      recovery of damaged intestinal barrier function in cell culture, animal models, patients with
      AIDS, and underweight children.

      Oral supplementation with Alanyl-Glutamine (Ala-Gln; 24g a day for 10 days) improves
      short-term gut integrity and weight velocity 4 months after therapy in a group of
      undernourished children from Northeast Brazil. Intervention and Mechanisms of
      Alanyl-Glutamine for Inflammation, Nutrition, and Enteropathy (IMAGINE) is a study designed
      to answer the following questions: 1) What is the lowest dose of Ala-Gln that improves
      intestinal barrier function, intestinal inflammation, and nutritional status in children at
      risk of underweight, wasting, or stunting? 2) What are the mechanisms by which Ala-Gln exerts
      these benefits?
    


Intervention name(s): Alanyl-Glutamine
Intervention type(s): Dietary Supplement
Intervention description(s): Alanyl-Glutamine and Glycine doses will be prepared immediately prior to administration by dissolving in formula, milk, or fruit juice. Administration of each dose will be directly observed by a study nurse or health agent.
Other intervention name(s): AminoStable (Ajinomoto)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: L-Alanyl-L-Glutamine; Environmental enteric dysfunction; Tropical enteropathy
Oral Administration of Four Lactobacillus Species Preparation to Improve the Quality of the Neovaginal Flora in Male to Female Transsexual Patients
Condition: Reduction or Absence of Lactobacilli in Neovaginal Flora
Study type: Interventional

Summary: 
      The aim of this study is the improvement of the penile linked neovaginal flora in
      male-to-female transsexuals after application of oral probiotics.
    


Intervention name(s): Probiotics; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): lyophilised L. rhamnosus, L. jensenii, L. crispatus, L. gasseri and sodium alginate; control group would receive a oral lactose placebo
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
General vs. Intrathecal Anesthesia for Total Knee Arthroplasty
Condition: Arthritis
MeSH terms: Arthritis
Study type: Interventional

Summary: 
      Hypothesis: General anesthesia as compared to intrathecal (i.e. spinal anesthesia) anesthesia
      will result in shorter length of hospital stay for patients undergoing total knee
      arthroplasty.

      Primary endpoint: time from end of surgery until the patient is "street ready"

      Secondary endpoints: will general anesthesia produce less postoperative pain as compared to
      intrathecal anesthesia? Is there any difference in post operative "dizziness" between the
      groups.
    

Detailed description: 
      Hypothesis: General anaesthesia compared to intrathecal anaesthesia will give shorter length
      of hospital stay (LOS) for patients undergoing total knee arthroplasty (TKA).

      Primary endpoint: time from end of surgery until the patient meets the discharge criteria.

      Secondary endpoints:

        1. Will general anesthesia produce less post operative pain?

        2. Is there any difference in post operative orthostatic function (dizziness) between the
           groups?

        3. Time until the patient meets the discharge criteria from PACU

        4. How many patients will need at least one urinary bladder catheterization?
    

Intervention name(s): General anesthesia; Regional anesthesia
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients will receive general anesthesia using propofol 10 mg/ml and remifentanil 50 ug/ml; Patients will receive intrathecal anesthesia
Other intervention name(s): Suxamethonium 50 mg/ml is used to fascilitate intubation. Ventilation is done using oxygen and air.; Patients will receive bupivacaine 5 mg/ml intrathecally. Also the will receive propofol 10 mg/ml to produce a ligth level of sedation.
Intervention MeSH terms: Bupivacaine; Anesthetics; Propofol; Succinylcholine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Arthritis; General anaesthesia; Spinal anaesthesia