bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Immediate vs Gradual Switch to Divalproex in Adults With Intellectual Disability
Condition: Epilepsy
MeSH terms: Epilepsy; Intellectual Disability
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether there is any difference in side effects
      experienced by individuals with intellectual disorders taking Depakote DR (immediate release
      form) when they are switched to the extended release form (ER) overnight versus when they
      switch more gradually over a week.
    

Detailed description: 
      Considering that there are potential advantages to once-daily depakote extended release in
      terms of decreased side effects, decreased medication errors and patient compliance, there is
      a need to determine the best method of conversion from multiple-daily dose delayed release
      depakote to once-daily for subjects with epilepsy bipolar disorder or behavior disorders.
    

Intervention name(s): Divalproex; Divalproex
Intervention type(s): Drug; Drug
Intervention description(s): Divalproex, 8-20% taper; Divalproex, 8-20% taper
Other intervention name(s): Depakote; Depakote
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intellectual disabilities; development disabilities; behavior disorders; stable epilepsy
Soft Tissue Esthetic With Autogenous Dentin Chips and Immediate Implantation Versus Conventional Immediate Implantation With Xenograft in Thin Buccal Bone
Condition: Crestal Bone Loss
Study type: Interventional

Summary: 
      After tooth extraction, host bone resorption and atrophy of alveolar ridge may be observed.
      Bone resorption occurs specially in incisors and premolar area of jaw in region of thin
      buccal bone that may lead to change in contour. Total clinical bone loss height approximately
      2-5 mm at first 6 months may be observed in vertical dimension , after 12 months alveolar
      ridge may lose up to 50 % of its width.
    

Detailed description: 
      Recently augmentation with bone grafting became one of the most common techniques surgically
      ; progressive bone resorption may be prevented by using augmentation procedures with use of
      graft materials. The gold standard in regenerative procedures is autogenous bone graft
      because of osteoinduction , osteoconduction and osteointergration properties required in
      regeneration. In autogenous bone graft there is need for a second surgical site , donor site
      morbidity and limited availability will lead to challenge for alternative bio-materials.

      Extracted healthy non functional teeth from human are considered to be a dental waste all
      over the world. High proportion of extracted sockets are left untreated for physiological
      healing. Inadequate or failure of bone healing in sockets has been seen due to absence of
      bone graft material. Stem cells, matrix , trace metal ions and growth factors are rich in
      human tooth. Bone and dentin tissue structure are different but ratio of components is
      similar (mineral 70% , collagen 20% and body fluid 10% by weight). Dentin after
      demineralization is mainly composed of type 1 collagen 95% and non collagenous proteins as
      growth factors.
    

Intervention name(s): immediate implant with dentine chips; conventional immediate implant
Intervention type(s): Procedure; Procedure
Intervention description(s): Using dentin chips; using xenograft
Other intervention name(s): Conventional immediate implantation; immediate implantation with xenograft
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: dentin; immediate implant; buccal bone resorption; crestal bone loss
Study of Real Clinical Practice to Evaluate the Effects of Oral Dydrogesterone for Treatment of Confirmed Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Observational

Summary: 
      A non-interventional, observational program to assess the effects of dydrogesterone
      (Duphaston®) 6-months-administration in patients with confirmed endometriosis in a
      post-marketing setting in the Russian Federation
    

Detailed description: 
      A non-interventional, observational program to assess the effects of oral dydrogesterone
      therapy in a post-marketing setting whether the effects are related to the regimen of
      dydrogesterone therapy. In this observational program, assuming that dydrogesterone plays a
      role in the treatment of endometriosis without suppression of ovulation, the goal is to
      observe the possible implications of such treatment in terms of treatment regimen and
      response pattern. In the study will be described effects of Duphaston®
      6-months-administration in patients with confirmed endometriosis by assessing pain relief,
      quality of life, need of self-medication with analgesics, etc.
    

Intervention name(s): Duphaston® (Dydrogesterone); Duphaston® (Dydrogesterone)
Intervention type(s): Drug; Drug
Intervention description(s): No intervention. Duphaston® is prescribed according local labelling for treatment of endometriosis 10 mg 2-3 times a day from the 5th to the 25th day of the menstrual period cycle. Description of routine practice only.; No intervention. Duphaston® is prescribed according local labelling for treatment of endometriosis 10 mg 2-3 times a day continuously. Description of routine practice only.
Intervention MeSH terms: Dydrogesterone
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Females aged 18 to 45 years, suffering external genital endometriosis confirmed by
        laparoscopy, for whom were prescribed treatment with Duphaston®
      
Keywords: endometriosis; dydrogesterone; Duphaston®; progestogens; pelvic pain
Effectiveness of a School-Based Hand Sanitizer Program on Reducing Asthma Exacerbations
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Asthma is a common, serious illness among children in the United States. Improving hand
      cleanliness and hygiene may prevent the spread of viruses that can cause asthma
      exacerbations. This study will evaluate the effectiveness of a school-based hand sanitizer
      program at reducing the frequency of exacerbations in children with asthma.
    

Detailed description: 
      In the United States, almost 9 million children have been diagnosed with asthma. It is a
      leading cause of hospitalizations and school absenteeism among children. Asthma symptoms are
      often seasonal, with the greatest number of exacerbations occurring in autumn and the fewest
      in mid-summer. Elementary school children are the most vulnerable to these seasonal changes,
      and many children experience an increase in exacerbations at the beginning of the school
      year. Recent research suggests that this seasonal peak in exacerbations is primarily caused
      by viral respiratory tract infections that are spread among children in school. Regular
      handwashing has been widely recognized as the most effective way to stop the spread of
      viruses and infectious illnesses. However, effective handwashing methods among school-age
      children can be inconsistent. Time constraints, a frequent lack of soap and towels,
      inconveniently located sinks, and water-saving faucets are all barriers to thorough
      handwashing. Improving hand hygiene through the use of antimicrobial rinse-free hand
      sanitizers in school classrooms may be a simple and effective way to reduce the risk of
      transmitting viruses that can cause asthma exacerbations. The purpose of this study is to
      evaluate the effectiveness of a school-based hand sanitizer program at decreasing
      exacerbations in children with asthma.

      This study will enroll children with asthma who are attending one of the 32 participating
      schools. Each school will be randomly assigned to either use their usual hand hygiene
      practices in Year 1, followed by a two-step hand hygiene program including hand washing plus
      hand sanitizer in Year 2, or vice versa. Each participant will log in to an Internet-based
      data collection system on a daily basis to document their asthma symptoms and peak flow meter
      readings. Teachers will also log in daily to verify participants' data and to document
      participants' absences and the reason for the absence. Quick relief medication use will be
      recorded and measured through the use of a Doser device on participants' inhalers.
    

Intervention name(s): Active Hand Sanitizer
Intervention type(s): Other
Intervention description(s): Active Hand Sanitizer
Other intervention name(s): Purell
Intervention MeSH terms: Hand Sanitizers
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hand Sanitizer; Respiratory Infection
Proof Of Mechanism Study To Determine Efficacy Of PF-04455242 In Blocking Spiradoline (PF-00345768) Stimulated Prolactin Release
Condition: Bipolar Depression
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be a Proof of Mechanism (POM) study to establish evidence of central
      pharmacodynamic activity for PF 04455242, and will be a parallel group, randomized, double
      blind, sponsor open study conducted in healthy male subjects. Once subjects achieve steady
      state of PF 04455242, they will undergo PF 00345768 (spiradoline) challenge. Data will be
      analyzed to determine whether PF-04455242 blocks spiradoline induced prolactin release.
    


Intervention name(s): PF-04455242; spiradoline; Placebo; spiradoline; PF-04455242; spiradoline
Intervention type(s): Drug; Drug; Other; Drug; Drug; Drug
Intervention description(s): Single oral 18 mg dose of PF-04455242.; Spiradoline 3.2 mcg/kg to be administered intramuscularly once on the morning of the spiradoline challenge day.; Oral placebo.; Spiradoline 3.2 mcg/kg to be administered intramuscularly once on the morning of the spiradoline challenge day.; Single 30 mg oral dose of PF-04455242.; Spiradoline 3.2 mcg/kg to be administered intramuscularly once on the morning of the spiradoline challenge day.
Intervention MeSH terms: Spiradoline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Proof of mechanism study
Feasibility of Combining Family and Cognitive Therapy to Prevent Chronic Anorexia
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Interventional

Summary: 
      This study aims to investigate the feasibility of combining Cognitive Remediation Therapy
      (CRT) with Family Based Treatment (FBT) for future use in a randomized clinical trial to
      reduce the risk of adolescents developing persistent Anorexia Nervosa. Participants will be
      randomly assigned to one of two groups: one group will receive FBT and CRT, and the other
      group will receive FBT and art therapy.
    


Intervention name(s): FBT and CRT; FBT and art therapy
Intervention type(s): Behavioral; Behavioral
Other intervention name(s): Family-Based Treatment (FBT) combined with Cognitive Remediation Therapy (CRT); Family-Based Treatment (FBT) combined with art therapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Eating Disorder; Anorexia Nervosa; Eating Disorder Not Otherwise Specified; Maudsley; Family-Based Therapy; FBT; Family Therapy; Cognitive Remediation Therapy; CRT
Intravenous Ketorolac for Postoperative Pain in Percutaneous Nephrolithotomy
Condition: Renal Calculus; Kidney Stones
MeSH terms: Kidney Calculi; Nephrolithiasis; Pain, Postoperative; Calculi
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether continuous intravenous ketorolac infusion
      reduces pain in patients who are having percutaneous nephrolithotomy for kidney stone
      disease.
    


Intervention name(s): Ketorolac; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.; 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
Other intervention name(s): Toradol; Acular
Intervention MeSH terms: Ketorolac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Percutaneous; Nephrolithotomy; Kidney stones
The Effects of Pregabalin on Postoperative Pain After Cardiac Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine whether pregabalin is effective in the treatment of
      acute postoperative pain after cardiac surgery if administered before the surgery.
    

Detailed description: 
      Pregabalin was introduced as an antiepileptic drug with analgesic anti-hyperalgesic and
      anxiolytic properties and was also used to treat neuropathic pain. In recent years it has
      been used as part of a multimodal management of acute postoperative pain after various types
      of surgery. We study the effect of pregabalin administered before cardiac surgery on acute
      and chronic postoperative pain. Post CABG syndrome is well known since 1980 and various
      analgesic methods have been used from time to time (opioids, regional analgesia,
      non-steroidal anti-inflammatory drugs). In our research patients will be divided into three
      groups. The control group will receive a placebo capsule before surgery. The second group
      will receive 75mg of pregabalin per os before surgery while the third will receive 150mg of
      pregabalin. After the surgery all patients will be connected to an intravenous PCA morphine
      pump for 48 hours. The postoperative pain will be assessed with the Visual Analogue Scale
      (0-10) every day. Total morphine consumption by the patients as well as any other pain
      medications administered supplementary will be registered and compared between the different
      groups. Remaining postoperative pain will be assessed after 3 months. The results will be
      statistically analyzed in order to determine whether there is significant difference in pain
      management between the groups.
    

Intervention name(s): Pregabalin 75mg; pregabalin 150 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pregabalin 75mg by mouth one hour before surgery; pregabalin 150mg by mouth one hour before surgery; Sugar pill designed to mimic pregabalin capsule, by mouth one hour before surgery
Other intervention name(s): Lyrica; Lyrica; Sugar pill
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: cardiac surgery; pregabalin; postoperative pain
Effect of Liraglutide for Weight Management in Pubertal Adolescent Subjects With Obesity
Condition: Metabolism and Nutrition Disorder; Obesity
MeSH terms: Obesity; Nutrition Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted globally. The aim of this trial is to investigate the effect of
      liraglutide for weight management in pubertal adolescent subjects with obesity.
    


Intervention name(s): Liraglutide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered once daily subcutaneously (s.c., under the skin); Administered once daily subcutaneously (s.c., under the skin)
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Clinical Study With Aliskiren Alone or in Combination Therapy With Diuretic Hctz in Venezuelan Hypertensive Patients.
Condition: High Blood Pressure
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open-label, not controlled, sequential, dose escalation study of 16 weeks'
      duration. The study is composed of two periods: a 0-2 week optional wash-out period depending
      on previous antihypertensive treatment(s), followed by a 16-week open-label active treatment
      period. Patients will be evaluated every 4 weeks during period 2. Treatment will start with
      Aliskiren 150 mg with dose titration to Aliskiren 300 mg, and addition of HCTZ 12,5 mg and 25
      if control of BP is not achieved (< 140/90 mmHg or 130/ 80 mmHg in diabetics patients). All
      patients who have reached their BP target will be considered as having met the primary
      endpoint and this visit will be considered as the final visit.
    


Intervention name(s): Aliskiren and HCTZ
Intervention type(s): Drug
Intervention description(s): Aliskiren 150 mg and 300 mg Hydrochlorothiazide 12.5 mg and 25 mg
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: high blood pressure; aliskiren; hydrochlorothiazide; control rate
Effect of 14:10 Time-Restricted Eating on Body Weight and Metabolic Markers
Condition: Time Restricted Feeding
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of engaging in time restricted eating
      schedule on body weight, blood glucose, and ketones (breath acetone) in individuals with
      obesity.
    

Detailed description: 
      There are significant metabolic and weight reduction benefits associated with time restricted
      feeding/eating. Time restricted eating splits the day into a period of regeneration
      (non-eating or natural fasting) and a period of nourishing. Providing the body a period of
      regeneration allows the body to go into ketosis, or the elevation in circulating ketone
      bodies, a byproduct of fat metabolism. Breath acetone concentration is a good predictor of
      ketosis and loss of body fat. In healthy individuals, low concentrations of breath acetone
      are 1 to 2 ppm. Engaging in weight loss via nutritional ketosis (engaging in high-fat,
      low-carbohydrate diets, caloric restriction diets, or fasting) increases fat utilization,
      resulting in increased formation of ketone bodies and breath acetone concentrations ranging
      from 4 to 30 ppm. In individuals with obesity, nutritional ketosis facilitates weight loss
      and improves insulin sensitivity, lipid profile, and reduces inflammatory markers.

      This study will investigate the effect of participating in two different time restricted
      eating schedules for 8 weeks on body weight, blood glucose, and ketones.

      After being informed about the study and potential risks, all eligible participants giving
      written informed consent will be randomized to a different time restricted eating schedule
      (ie, one group fasts for a longer period of time). In both of these groups, fasting will
      begin each evening and end the following morning.

      This is a remote study. All procedures will be conducted at home.
    

Intervention name(s): 14:10 Regimen; 12:12 Regimen
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 14 hours of fasting, followed by a 10-h diet regimen that includes a fasting snack at 12 hours from the start of the fasting period; 12 hours of fasting, followed by a 12-h diet regimen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: body weight; weight loss; ketones; blood glucose
Exercise Training in ICD Recipients; Effect on Therapy Delivered, Depression and Anxiety
Condition: Ventricular Tachycardia
MeSH terms: Tachycardia; Tachycardia, Ventricular
Study type: Interventional
Phase: Phase 3

Summary: 
      Interventional study in patients with ICD. Controlled, open intervention with exercise
      training. Assessment of changes in physiological and psychological parameters.
    

Detailed description: 
      ICD therapy with DC shock is associated with impaired quality of life and development of
      anxiety and depression. In a selected group of patients with ICD the intervention with
      organized high intensity training is evaluated. Peak VO2, inflammatory profile, performed
      interventions by the ICD and psychological profile is assessed. In addition a qualitative
      evaluation using interviews is performed.
    

Intervention name(s): Exercise training
Intervention type(s): Behavioral
Intervention description(s): 3 months supervised interval training
Other intervention name(s): ICD, exercise training
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ICD, training
A Non-interventional Study Evaluating the Clinical Benefit and Effectiveness of Quetiapine Fumarate Extended
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      The primary objective of this NIS is to assess the clinical benefit subjects derive from
      taking seroquel XR, using the CGI-CB. The secondary objective is to assess the
      effectiveness,safety and tolerability of seroquel XR tablets.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult diagnosed as Schizophrenia according to DSM-IV-TR criteria, the groups will be
        selected selected from general hospital or mental hospital.
      
Keywords: Schizophrenia; Seroquel XR; CGI-CB; SWN-K
Effect of Curodont™ Repair in Patients With Early Approximal Carious Lesions
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the therapeutic benefit of Curodont Repair for the
      treatment of early approximal carious lesions compared to fluoride.
    

Detailed description: 
      All study participants must have two early approximal carious lesions in need of a treatment
      but not of an invasive treatment (split-mouth design). One lesion will be treated with
      Curodont Repair and one with fluoride as control. Study duration is 24 months. For assessment
      x-ray pictures, Diagnodent Pen and DiagnoCam is used.
    

Intervention name(s): Curodont Repair; Fluoride
Intervention type(s): Device; Device
Intervention description(s): Self-assembling peptide, biomimetic re-mineralisation
Application on Day 0 and Day 360; Application on Day 0, Day 180, Day 360, Day 540
Other intervention name(s): P11-4; Duraphat
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Dental caries; Curodont Repair; P11-4