bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Liquid Zinc Supplementation and Dispersible Zinc Tablets on Plasma Zinc Concentration
Condition: Zinc Deficiency
Study type: Interventional

Summary: 
      The study aims to compare the effects of two different formulations of zinc supplements on
      plasma zinc concentrations among young Burkinabe children.
    

Detailed description: 
      1) To investigate the effects of short-term zinc supplementation, provided either as a
      dispersible tablet containing zinc sulfate ("ZinCfant," Nutriset Ltd; Malaunay, France) or as
      a liquid ZnSO4 solution, on changes in serum zinc concentration, compared with a placebo in
      young Burkinabe children; and 2) to assess the relationship between change in serum zinc
      concentration and the presence of altered intestinal permeability within each treatment
      group.
    

Intervention name(s): Liquid zinc syrup; Zinc tablet; Liquid placebo supplement
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Liquid zinc syrup containing 5 mg zinc as zinc sulfate; Dispersible zinc tablet containing 5 mg zinc; Liquid placebo supplement containing 0 mg zinc
Other intervention name(s): Phytofla, Banfora, Burkina Faso; Nutriset S.A.S., France; Phytofla, Banfora, Burkina Faso
Intervention MeSH terms: Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: zinc supplement; prevention; zinc deficiency; plasma zinc concentration
Full-mouth Periodontal Debridement and Metronidazole Gel in Patients With Chronic Periodontitis
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Hypothesis: metronidazole gel applied topically after periodontal debridement in smokers
      volunteers could improve clinical parameters when compared to metronidazole tablets +
      periodontal debridement. Method: 30 smokers with chronic periodontitis were randomly assigned
      into 3 groups: periodontal debridement combined with 3 g placebo gel; periodontal debridement
      combined with daily topical application of 3 g metronidazole benzoate gel (15%); and
      periodontal debridement combined with a daily single dose of 750 mg metronidazole. Clinical
      parameters evaluated were visible plaque, gingival bleeding, probing pocket depth and
      relative attachment level.
    

Detailed description: 
      Background. The benefit of adjunctive metronidazole on periodontal procedure in smokers with
      chronic periodontitis (CP) is uncertain. The authors compared the effect of metronidazole
      (Mtz) on full-mouth periodontal debridement (PD= 1 hour of ultrasonic calculus/plaque
      removal) in smokers with CP.

      Methods. This pilot study involved 30 Individuals (having at least six teeth with a clinical
      attachment loss of ≥ 5 mm and probing pocket depth (PPD) of ≥5 mm) that were randomly
      assigned into three groups (n=10): 1) PD plus 3 g of placebo gel daily topical application 2)
      PD plus daily topical application of 3 g of 15% Mtz benzoate gel; and 3) PD plus a daily
      single dose of 750 mg Mtz (Flagyl®). Clinical parameters visible plaque index (VPI), gingival
      bleeding index (GBI), relative attachment level (RAL) and PPD; and the quantitative analysis
      (real-time PCR) of Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis and
      Tannerella forsythia were assessed baseline, 1, 3 and 6 months after PD.
    

Intervention name(s): Full-mouth periodontal debridement; Metronidazole tablet; placebo gel; Metronidazole benzoate gel
Intervention type(s): Procedure; Drug; Drug; Drug
Intervention description(s): full-mouth periodontal debridement using an ultrasonic device in a single session for approximately 1 hour; 750 mg metronidazole tablets; semi-solid suspension containing carbopol; 15% Mtz benzoate in semi-solid suspension containing carbopol (gel)
Other intervention name(s): PD; MTZ tablet; MTZ GEL
Intervention MeSH terms: Metronidazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic periodontitis; metronidazole
Effect of a Nutritional Approach in Combination With Cognitive Stimulation on Child Cognitive Abilities
Condition: Healthy
Study type: Interventional

Summary: 
      The objective of the study is to explore the impact of a combined intervention including a
      growing up milk (GUM) fortified in micronutrients and cognitive stimulation on cognitive
      abilities, mother-child- interaction and behavior in children of 3 to 5 years from less
      enriched home environments.
    

Detailed description: 
      The objective of the study is to explore the impact of a combined intervention including a
      growing up milk (GUM) fortified in micronutrients and cognitive stimulation on cognitive
      abilities, mother-child- interaction and behavior in children of 3 to 5 years from less
      enriched home environments with HOME score less than 26. The control group will receive
      skimmed milk but no extra stimulation materials ( however, no restrictions on normal
      mother-child interaction). The cognitive abilities, mother-child interaction and child
      behavior will be assessed after a 6 months intervention.
    

Intervention name(s): StimuLearn Intervention; Without StimuLearn intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): StimuLearn apps
Cognitive questionnaires; Cognitive Questionnaires
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
A Study Utilizing Patient-Reported Outcomes to Evaluate the Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      This phase 3 study is a multicenter, randomized, double-blind, placebo-controlled study of
      lorecivivint injected intraarticularly (IA) into the target knee (most painful) joint of
      moderately to severely symptomatic osteoarthritis (OA) subjects at a single dose of 0.07 mg
      lorecivivint per 2 mL injection. This study will utilize patient reported outcomes (PROs) to
      evaluate the safety and efficacy of lorecivivint.
    


Intervention name(s): Lorecivivint; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): One intra-articular injection of 0.07 mg lorecivivint in 2 m vehicle; One intra-articular injection of 0 mg lorecivivint in 2 m vehicle
Other intervention name(s): SM04690; Vehicle
Intervention MeSH terms: Lorecivivint
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SM04690; Wnt pathway inhibitor; osteoarthritis; Samumed; lorecivivint
Cognitive Processes Study in Obese Women With and Without Eating Disorders
Condition: Hyperalimentation and Obesity
MeSH terms: Hyperphagia; Feeding and Eating Disorders
Study type: Interventional

Summary: 
      The P300 is one of the cognitive wave of the Event-Related Potential (ERP) that is used to
      investigate the cognitive process. The P300 component are accepted as electro-physiological
      markers of neuropsychiatric disorders like alcoholism or drug addiction.

      Recent scientific data suggest that eating disorders, leading to weight gain and obesity,
      will be similar of those of drug addiction: it is the incentive sensitization theory that
      implicates the dopaminergic reward system.

      The aim of this cross-sectional study is to investigate the alteration of P300 auditory ERP
      in obese women with eating disorders in comparison with obese and lean women without eating
      disorders.
    


Intervention name(s): electroencephalography; Blood sampling; Questionnaires regarding eating habits (TFEQ, EDI) and anxiety/depression (HAD)
Intervention type(s): Procedure; Biological; Behavioral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Obesity; Hyperalimentation; Event-Related Potential; P300
A Study to Assess the Absolute Bioavailability of Oral Selumetinib in Healthy Male Volunteers.
Condition: Healthy Volunteers Bioavailability Study
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the absolute bioavailability of oral selumetinib in healthy male volunteers
    


Intervention name(s): selumetinib 75mg single dose; [14C] selumetinib IV solution
Intervention type(s): Drug; Other
Intervention description(s): 3 capsules of 25 mg given as a single dose; single, radiolabeled, IV (infused), microdose (80 μg) of [14C] selumetinib, infused using a syringe pump as a 15-minute infusion, administered 1h 15 min after receiving the oral dose
Other intervention name(s): Selumetinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: bioavailability; pharmacokinetics; I phase; AZD6244; cancer
Parental Education and Children's Screen Time
Condition: Screen Time
Study type: Interventional

Summary: 
      The study was to investigate the efficacy of a parental educational program on reducing
      screen use, and improving sleep quality and psychosocial adaptations in children aged 4-6
      years.
    

Detailed description: 
      A total of 129 parent-child dyads were randomly allocated to two groups: experimental group
      (receiving parental education, n=63), and control group (daily activities, n=66). Data were
      collected before and after intervention. Instruments included screen time, Children's Sleep
      Habits Questionnaire, and Pediatric Symptom Checklist-17. A linear mixed model analysis was
      used to examine the efficacy of education intervention.
    

Intervention name(s): experimental group; control group
Intervention type(s): Behavioral; Other
Intervention description(s): This program was carried out for 50 min/week over 8 weeks to empower parents with knowledge and self-efficacy about children's screen use, and motivate them to monitor and change their children's screen behaviors. Teaching strategies included lectures, group discussions, reflection, role playing, and peer sharing (Table 1). Topics included 1) parents' and children's screen use, 2) the relationship between network equipment and children's internet use, 3) the positive and negative effects of excessive screen use on children's physical and psychological development, 4) limiting screen use at mealtimes and bedtime, 5) strategies for screen-related devices, 6) alternative activities to screen use, such as board games and outdoor activities, 7) setting a target of appropriate screen times, and 8) encouraging the signing of a contract between parents and children to limit screen time. We also provided parents with a handbook of the course content.; received standard school classes and usual activities offered at the kindergarten. Briefly, kindergarten activities included daily learning activities, outdoor activities, breakfast, lunch, snacks, and nap time.
Other intervention name(s): parental educational program; usual activity
Intervention model: Single Group Assignment
Intervention model description: A clustered randomized controlled study with a parallel-group design.
Masking: None (Open Label)
Primary purpose: Prevention
Medication Adherence in Patients With Inflammatory Bowel Disease (IBD)
Condition: Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis
MeSH terms: Crohn Disease; Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      The purpose of this is to formally assess health literacy and medication adherence in
      participants with Inflammatory bowel disease (IBD). The study also aims to improve medication
      adherence, health-related quality of life, and disease activity through a 24-week
      intervention.
    

Detailed description: 
      The purpose of this study is to formally assess health literacy and medication adherence in
      participants with Inflammatory bowel disease (IBD). The study also aims to improve medication
      adherence, health-related quality of life, and disease activity through a 24-week
      intervention that will include telephone reminders, educational materials, visits to the
      physician, and financial counseling.
    

Intervention name(s): Education and Reminders; Educational Visit; Medication Educational Visit; Financial Support
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants will be provided education materials, and will receive scheduled educational reminder phone calls and text messages at 2,6,12, and 24 weeks from the baseline assessment.; Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence.Participants will undergo one scheduled visit with a nurse practitioner or physician for education about inflammatory bowel disease (IBD) after the baseline assessment.; Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants will undergo one scheduled visit with a nurse practitioner or physician to discuss medication side effects and medication inadequacy after the baseline assessment.; Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants will receive information about patient assistance programs, copay cards, and a scheduled meeting with a social worker or financial advisor.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Digestive Disease and Disorders; Inflammation
Benzamide Derivates as Treatment of Clozapine-induced Hypersalivation
Condition: Clozapine-induced Hypersalivation
MeSH terms: Sialorrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      Hypersalivation (sialorrhea or ptyalism) is known as a frequent, disturbing, uncomfortable
      adverse effect of clozapine therapy, and until now there is not enough effective treatment
      for this side effect leading to noncompliance.

      In previous studies it was found that substitute benzamide derivatives with higher selective
      binding to the D2/D3 dopamine receptor - amisulpride and sulpiride may be effective in
      treatment of clozapine-induced hypersalivation (CIH). Today, in psychiatric practice in
      Israel, there are four medications which belong to substitute benzamide derivatives group:
      amisulpride, sulpiride, tiapride and moclobemide. We hypothesized that antisalivation effect
      is universal for the whole group of benzamide.

      The aim of our study was to compare efficacy of amisulpride, moclobemide (reversible
      monoamine oxidase inhibitor-A (RIMAS)), and tiapride (dopamine D2 antagonist) as an
      additional possibility for management of CIH.
    

Detailed description: 
      The pilot study will be conducted in two mental health centers. In order to examine our
      hypothesis, we will use an add-on design. Into the study will be enrolled 50 patients with
      schizophrenia and schizoaffective disorder (males and females, 19-60 years old), according to
      the DSM-IV criteria, treated with clozapine and suffering from hypersalivation.
    

Intervention name(s): Amisulpride, Moclobemide
Intervention type(s): Drug
Intervention description(s): Amisulpride 400 mg/d; Moclobemide 300 mg/d every medication for 2 week aith 2 week washout
Intervention MeSH terms: Amisulpride; Moclobemide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Sitagliptin Versus Placebo in the Treatment of Non-alcoholic Fatty Liver Disease
Condition: Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Nonalcoholic fatty liver disease (NAFLD) represents a spectrum of diseases ranging from
      simple steatosis to nonalcoholic steatohepatitis (NASH), the progressive form of liver
      disease that can lead to cirrhosis and liver-related mortality in persons who drink little or
      no alcohol. NAFLD is defined as the presence of hepatic steatosis with no evidence of
      hepatocellular injury in the form of ballooning of the hepatocytes. NASH is defined as the
      presence of hepatic steatosis and inflammation with hepatocyte injury (ballooning) with or
      without fibrosis. NASH is benign in many affected individuals but can cause progressive liver
      injury and, indeed, may be the major cause of cryptogenic cirrhosis1. Currently, there is no
      FDA approved treatment for NAFLD. Weight loss and exercise are the recommended but often
      difficult maintain these lifestyle changes in the long term and therefore therapeutic agents
      have been investigated. In this study, we propose to treat 50 patients with NAFLD and
      diabetes with either sitagliptin or placebo for 24 weeks. After an initial evaluation for
      insulin sensitivity and MRI liver fat distribution, patients will receive either 100 mg/day
      of sitagliptin or placebo. Patients will be monitored at regular intervals for symptoms of
      liver disease, side effects of sitagliptin and serum biochemical and metabolic indices. At
      the end of 24-weeks, patients will have a repeat medical evaluation, liver MRI and an
      optional liver biopsy. Pre and post treatment MRI-derived liver fat content and insulin
      sensitivity will be compared. The primary end point of successful therapy will be improvement
      in hepatic steatosis measured by MRI. Secondary end points will be improvement in insulin
      sensitivity and liver biochemistry.
    

Detailed description: 
      Primary objectives:

      1. To examine the efficacy of sitagliptin 100 mg orally daily versus placebo in improving
      hepatic steatosis assessed by magnetic resonance imaging in patients with NAFLD.

      Secondary objectives:

        1. To examine the efficacy of sitagliptin in improving serum AST in patients with NAFLD.

        2. To examine the efficacy of sitagliptin in improving serum ALT in patients with NAFLD.

        3. To examine the efficacy of sitagliptin in improving serum LDL in patients with NAFLD.

        4. To examine the efficacy of sitagliptin in the improvement of insulin sensitivity in
           patients with NAFLD.
    

Intervention name(s): Sitagliptin; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Smartphone-based Mobility Assessment and Individualized Exercise Programs for Patients With Frozen Shoulder
Condition: Frozen Shoulder
MeSH terms: Bursitis
Study type: Interventional

Summary: 
      This study was to investigate the reliability and validity of the smartphone goniometer app
      to measure shoulder ROM in a modified position for patients with frozen shoulder, and compare
      the intervention effect and adherence to home exercise between the smartphone and traditional
      paper hangouts.
    

Detailed description: 
      This study was to investigate the reliability and validity of the smartphone goniometer app
      to measure shoulder ROM in a modified position for patients with frozen shoulder, and compare
      the intervention effect and adherence to home exercise between the smartphone and traditional
      paper hangouts. The outcome measure including shoulder range of motion, pain condition, home
      exercise adherence and satisfaction of smartphone program
    

Intervention name(s): Smartphone; traditional paper hangouts
Intervention type(s): Other; Other
Intervention description(s): patients with frozen shoulder in the smartphone group will use the smartphone to conduct the home exercise program. The patients will be asked to follow the description to have mobility assessment at least 1 week and do the individualized exercise themselves.; patients with frozen shoulder in the smartphone group will use the paper hangouts to conduct the home exercise program. The content of the paper hangouts were description of the home exercise.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: frozen shoulder; smartphone; home exercise program; range of motion
Hybrid Mathieu Urethroplasty
Condition: Distal Penile Hypospadias (Disorder)
MeSH terms: Hypospadias
Study type: Interventional

Summary: 
      the aim is to study the results of simple modification of classic Mathieu urethroplasty to
      increase the scope of cases candidates for that procedure.
    

Detailed description: 
      background: Distal hypospadias repair is one of most frequent surgical interventions in
      pediatric age group. Successful hypospadias repair should provide a functional penis and good
      cosmesis. Mathieu urethroplasty is one of the most popular techniques used. Authors aimed at
      performing a modification that expanded the scope of indications and improved final cosmetic
      results of classic Mathieu urethroplasty.

      Methods: forty-three patients with distal hypospadias were operated by hybrid Mathieu
      urethroplasty (HMU) during the period from March 2012 to December 2020. Creation of the peri
      meatal based flap was performed as Mathieu disrobed. This was followed by developing of
      glanular wings. The additional step was deep incision of the urethral plate. Then,
      urethroplasty was performed. The catheter was left in place for one to three days.
    

Intervention name(s): hyebrid Mathieu Urethroplasty
Intervention type(s): Procedure
Intervention description(s): incision of the urethral plate during the procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: distal hypospadias; Mathieu urethroplasty; modified; urethral plate
Ketamine and Propofol for Upper Endoscopy
Condition: Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine the dose-response relationship of ketamine in
      combination with propofol.
    

Detailed description: 
      Direct visualization of the esophagus, stomach and small intestine is performed using a scope
      that is inserted while the patient is under under deep sedation or general anesthesia. The
      most common method of providing general anesthesia for upper endoscopy is intravenous
      administration of medications such as propofol, often in combination with other medications
      such as fentanyl, midazolam, remifentanil or ketamine. One study found that the combination
      of propofol and ketamine provides better conditions (less patient movement, more stable heart
      and breathing) but more side effects afterwards compared to propofol and fentanyl.
    

Intervention name(s): Ketamine; Propofol
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ketamine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ketamine; Propofol; Children; Pediatrics; Upper endoscopy