bioihbjkbjnl/mcl2 huggingface dataset:
Atorvastatin as an Adjunct to DFDBA in Intrabony Defects
Condition: Chronic Periaortitis; Intrabony Periodontal Defect
MeSH terms: Retroperitoneal Fibrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Periodontitis is a major oral health problem which leads to the progressive destruction of
      periodontal ligament and alveolar bone with pocket formation, recession or both. The ultimate
      goal of periodontal therapy is to regenerate the lost periodontal tissue. The most common
      form of regenerative periodontal therapy is the use of bone grafts which stimulate bone
      formation by the processes of osteoinduction and osteoconduction.

      Statins are a group of lipid lowering drugs which inhibit bone resorption by inhibition of
      the enzyme HMG-CoA reductase. They also stimulate new bone formation by local stimulation of
      BMP-2, a major bone growth regulatory factor. They also have anti-inflammatory and anti
      oxidant properties.

      Very few studies exist evaluating the beneficiary effects of grafts if combined with the
      statins which might enhance the regeneration by bone grafts.

      Hence, the present study was carried out in an attempt to comparatively evaluate clinically
      and radiologically, the efficacy of atorvastatin gel as an adjunct to allograft in the
      treatment of intrabony defects.
    

Detailed description: 
      A total of 26 intrabony defects in patients with chronic periodontitis as diagnosed by
      radiographs, were selected for the study after taking an informed consent. The selected sites
      were randomized in 2 treatment groups.

      Group I - sites were treated with allograft (DFDBA) Group II - sites were treated with
      allograft (DFDBA) in combination with Atorvastatin gel.

      Clinical parameters like probing depth and clinical attachment level and radiological
      assessment of intrabony defect fill were done at baseline and 3 and 6 months postoperatively.
    

Intervention name(s): DFDBA; DFDBA with atorvastatin
Intervention type(s): Biological; Drug
Intervention description(s): 13 intrabony defects in chronic periodontitis patients were treated with allograft (DFDBA); 13 intrabony defects in chronic periodontitis patients were treated with allograft (DFDBA) in combination with atorvastatin gel
Other intervention name(s): Allograft; atorvastatin gel
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Chronic periodontitis; atorvastatin; intrabony defect
HEMOCC Study. Hemostasis in Cirrhotic Children.
Condition: Esophageal and Gastric Varices; Child, Only
MeSH terms: Esophageal and Gastric Varices
Study type: Interventional

Summary: 
      Prospective investigations into the role of hemostatic factors in the risk of variceal
      bleeding among children with chronic liver disease (thromboelastometry e.g) is still
      required. A better understanding of these factors would permit better risk stratification and
      targeted prophylaxis or therapy.
    

Detailed description: 
      The investigators aim to start a prospective and observational study over a 2 years period.

      First, the investigators will identify all children suffering from cirrhosis irrespective of
      underlying etiology and/or portal hypertension coming into the pediatric
      hepatogastroenterology unit at Saint-Luc University Clinics. Any patient with a congenital or
      acquired thrombophilia/haemorrhagic disorder will be excluded. The investigators expect to
      include 20 to 30 children in the study.

      The investigators will meet the parents to give them explanations about this study and its
      implications. Then the investigators will get the free and informed consent about the
      participation to this clinical study. Parents are obviously free to refuse to take part in
      this clinical study and to retire from it at any moment.
    

Intervention name(s): Collecting Clinical Data; Collecting laboratory data
Intervention type(s): Other; Other
Intervention description(s): Clinical data as height, weight, mid upper arm circumference, jaundice, portal hypertension signs (ascites, splenomegaly, umbilical veinous circulation); Laboratory data as CRP, hemogram, albumin, total and conjugated bilirubin, creatinin, urea, liver enzymes, tests of hemostasis.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: The investigators aim to start a prospective and observational study over a 2 years period.
First, the investigators will identify all children suffering from cirrhosis irrespective of underlying etiology and/or portal hypertension coming into the pediatric hepatogastroenterology unit at Saint-Luc University Clinics. Any patient with a congenital or acquired thrombophilia/haemorrhaegic disorder will be excluded.
Masking: None (Open Label)
Primary purpose: Prevention
Merck Carotid Atherosclerosis Trial (MK-0000-111)(COMPLETED)
Condition: Carotid Atherosclerosis
MeSH terms: Carotid Artery Diseases; Atherosclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will examine the effect of statin and niacin therapy on carotid plaque biomarkers
    


Intervention name(s): Atorvastatin/niacin extended-release; Atorvastatin; Simvastatin; Simvastatin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 80 mg tablet atorvastatin once daily, 10 mg tablet placebo to atorvastatin once daily, and niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.; 10 mg tablet atorvastatin once daily, 80 mg tablet placebo to atorvastatin once daily, and placebo to niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.; (Russia and Brazil) 80 mg tablet simvastatin once daily, 10 mg tablet placebo to simvastatin once daily, and niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.; (Russia and Brazil) 10 mg tablet simvastatin once daily, 80 mg tablet placebo to simvastatin once daily, and placebo to niacin extended-release tablet starting at 500 mg daily and titrating to 2g daily. Treatment will be from 4 to 12 weeks.
Other intervention name(s): Lipitor, Niaspan; Lipitor; Zocor; Zocor
Intervention MeSH terms: Niacin; Atorvastatin; Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of Efficacy, Pharmacokinetics and Safety of Continuous Intravenous Infusion of Org 9426 (Study P05977)
Condition: Anesthesia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the infusion rate of Org 9426 following intubating
      dose of Org 9426 0.6 mg/kg or 0.9 mg/kg in adult surgical patients.
    


Intervention name(s): Rocuronium bromide; Rocuronium bromide; Rocuronium bromide; Sevoflurane; Propofol
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Continuous intravenous infusion initiated at 7 μg/kg/min and adjusted to maintain muscle relaxation; Intubation dose of 0.6 mg/kg injection; Intubation dose of 0.9 mg/kg injection; 0.5-2.0% intravenous maintenance anesthesia; 4010 mg/kg/hr intravenous maintenance anesthesia
Other intervention name(s): SCH 900085; SCH 900085; SCH 900085; Sevofrane; Diprivan
Intervention MeSH terms: Bromides; Propofol; Sevoflurane; Rocuronium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neuromuscular Blocking Agents
A Trial to Investigate the Safety, Tolerability, and Drug Levels in Blood After Single and Multiple Doses of LEO 32731 in Healthy People
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1 trial to evaluate the safety, tolerability, and pharmacokinetics of 4
      different oral formulations of LEO 32731 in healthy subjects. The trial will be conducted in
      3 parts at a single site. Each eligible subject will be enrolled into 1 group only and will
      participate in 3 treatment periods.
    

Detailed description: 
      Part 1 will evaluate the pharmacokinetics of single doses of 4 test formulations of LEO 32731
      compared with a reference formulation. Part 2 will evaluate the effect of food on the
      pharmacokinetics of selected test formulations of LEO 32731. Part 3 will evaluate the
      tolerability and safety of selected test formulations of LEO 32731 after multiple dosing.

      Based on data from Part 1, up to 3 formulations will be taken forward to Part 2. If none of
      the formulations are considered appropriate to take forward to Part 2, the trial will stop
      after Part 1. Similarly, based on data from Part 2, up to 2 formulations will be taken
      forward to Part 3. If none of the formulations are considered appropriate to take forward to
      Part 3, the trial will stop after Part 2.
    

Intervention name(s): LEO 32731 modified release tablet; LEO 32731 blend, hard capsule; LEO 32731 API, hard capsule; LEO 32731 soft capsule; LEO 32731 gastro-resistant capsule; LEO 32731; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Other
Intervention description(s): At each dosing, subjects will swallow the appropriate number of tablets with approximately 240 mL of water at room temperature.; At each dosing, subjects will swallow the appropriate number of capsules with approximately 240 mL of water at room temperature.; At each dosing, subjects will swallow the appropriate number of capsules with approximately 240 mL of water at room temperature.; At each dosing, subjects will swallow the appropriate number of capsules with approximately 240 mL of water at room temperature.; At each dosing, subjects will swallow the appropriate number of capsules with approximately 240 mL of water at room temperature.; At each dosing, subjects will swallow the appropriate number of tablets or capsules with approximately 240 mL of water at room temperature.; At each dosing, subjects will swallow the appropriate number of tablets or capsules with approximately 240 mL of water at room temperature.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Part 1 (single dose, cross-over) Part 2 (single dose, cross-over with food effect evaluation) Part 3 (multiple dose, parallel)
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: healthy
Brexpiprazole as Adjunctive Therapy in Adults With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The clinical trial will investigate the effect of brexpiprazole on the concept of life
      engagement in participants with Major Depressive Disorder (MDD) with a current depressive
      episode.
    

Detailed description: 
      This is a phase 4, multicenter, open-label, flexible dose trial designed to assess the
      effects of brexpiprazole (flexible dose; 0.5 to 2 milligrams [mg], once daily [QD]) as
      adjunctive therapy to antidepressant therapy (ADT) on life engagement in participants with
      MDD. This trial is being conducted in line with the Canadian Product Monograph.
    

Intervention name(s): Brexpiprazole
Intervention type(s): Drug
Intervention description(s): Oral brexpiprazole tablets as adjunctive therapy to ADT
Other intervention name(s): OPC-34712
Intervention MeSH terms: Brexpiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MDD; Depression; Brexpiprazole
The Immediate Effect of Manual Therapy Application on Respiratory Functions in Healthy Young Individuals
Condition: Health Young Individuals
Study type: Interventional

Summary: 
      Manual therapy techniques targeting the thoracic region are commonly used in clinical
      practice. It has been suggested that manual therapy interventions directed at the spine can
      increase mobility of the spine and chest wall, which may have a positive impact on lung
      functions. The potential positive effects of thoracic manipulation on respiratory system
      diseases such as chronic obstructive pulmonary disease (COPD) and asthma have been
      investigated and continue to be studied. Specifically, the results of studies investigating
      the physiological outcomes of this therapeutic approach in healthy adults are conflicting.
      The aim of this study is to investigate the short-term effects of thoracic manipulation and
      mobilization, as well as diaphragm mobilization, through a single session of manual therapy
      interventions on respiratory functions.
    

Detailed description: 
      In this planned study, designed as a randomized controlled intervention trial, two groups
      will be formed: an experimental group and a control group. After completing these procedures,
      the intervention group will receive the method of "thoracic mobilization and manipulation
      with diaphragm mobilization," while the control group will receive a placebo thoracic
      mobilization method. All techniques will be applied by a physiotherapist.

      Within 5 minutes after the completion of the intervention, a respiratory function test will
      be repeated, resulting in a total of two respiratory function tests: one before the
      intervention and one after the intervention. The changes in respiratory function criteria
      before and after the intervention will be compared in both groups
    

Intervention name(s): Manual therapy group; Sham-manual therapy
Intervention type(s): Other; Other
Intervention description(s): Manual therapy will be applied to the diaphragm and thoracic region.; Sham-manual therapy will be applied to the diaphragm and thoracic region.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Manual therapy; Respiratory function test; Physical activity
A Study to Evaluate the Safety and Antiviral Effect of ABT-450/Ritonavir and ABT-530 Coadministered With and Without Ribavirin in Adults With Genotype 3 Hepatitis C (HCV) Infection
Condition: Chronic Hepatitis C; Hepatitis C Virus
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and antiviral effect of ABT-450/r and
      ABT-530 coadministered with and without Ribavirin in adults with genotype 3 HCV infection.
    

Detailed description: 
      Once the efficacy and safety data were obtained from participants administered ABT-450/r +
      ABT-530 + RBV weight-based (Arm 1) in Study M14-213, the decision was made to end this study
      before subjects were enrolled into Arm 2.
    

Intervention name(s): ABT-450/ritonavir (r); ABT-530; Ribavirin (RBV)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablet; Tablet; Tablet
Other intervention name(s): ABT-450 also known as paritaprevir; pibrentasvir
Intervention MeSH terms: Ritonavir; Ribavirin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C; HCV; Interferon Free; Chronic Hepatitis C; Hepatitis C virus; Hepatitis C Genotype 3
Reconstruction of Skin Substance Loss With "Micro-grafts" Obtained by Mechanical Disintegration
Condition: Cutaneous Ulcer; Trauma Injury
MeSH terms: Skin Ulcer
Study type: Observational

Summary: 
      The etiology of non-healing ulcers depends on both systemic and local factors. The
      introduction of advanced dressing, negative wound therapy and compression therapy have
      undoubtedly improved clinical outcomes. The principal aim of study was to demonstrate the
      efficacy of skin micrografts in the treatment of skin substance loss.
    

Detailed description: 
      The principal aim of study was to evaluate the efficacy of skin micro-grafts obtained with
      the system of mechanical disintegration in the reconstruction of skin substance loss in the
      limbs.

      The primary endpoint consists in evaluating, through a specific evaluation scale, the Wound
      Bed Score (WBS) for skin substance loss at Time 0 (T0) and 30 days after the procedure (T30)
      and to evaluate the increase of this score in this time frame set at 50%. The evaluation will
      be carried out in double blind.

      The secondary endpoints instead consist in the evaluation of the Wound Surface Area
      Assessment to be carried out at T0 and T30.

      In the evaluation of the quality of the resulting scars, through the Vancouver Scale (VS), 90
      (T90) and 180 days (T180) after treatment and to evaluate the reduction of this score by 15%;
      on the other in the evaluation of the progress of the Visual Analogic Scale (VAS)
      administered to the patient at T0, 30, 90, 180.

      The purpose of this minimally invasive treatment is to improve the quality of life of those
      affected by these injuries, avoiding the use of prolonged advanced medications and / or more
      invasive surgical procedures, thus speeding up healing and favoring the clinical outcome of
      patients.

      No chemical reagents or enzymes are used for the method. There is therefore no tissue
      manipulation, in full compliance with the European directive 23/2004.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who attend the various regional hospitals through the emergency room or surgical
        clinic
Preventing Hypoglycemia During Exercise With Proactive Snacking on Closed Loop
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study is designed to look at how snacking during exercise may help prevent low blood
      sugars while subjects are on the "closed loop artificial pancreas." This system uses a
      continuous glucose sensor, an insulin pump, and a computer program that automatically
      determines how much insulin to give based on the sensor glucose level.
    

Detailed description: 
      This study will be a randomized cross-over study as subjects will be studied under both study
      conditions - Closed Loop (CL) alone vs. CL + proactive snacking protocol). Differences in the
      nadir blood glucose levels during exercise between the two study conditions will be the
      primary outcome measure.
    

Intervention name(s): Medtronic MiniMed Closed Loop (CL) System; Snacking
Intervention type(s): Device; Other
Intervention description(s): The Medtronic MiniMed Closed Loop (CL) System is an investigational system that uses some commercially available products. An investigational Enlite 2 glucose sensor measures the sensor glucose. The glucose sensor signal is sent to the insulin pump. From the insulin pump the sensor glucose is sent through the translator, which then relays the signal on to a controller. An Android Mobile Device (off the shelf) has the control algorithm installed. This device is known as the controller. The controller serves as the control center for the Android system, receiving data from the sensor and pump components, feeding the data to its control algorithm, issuing delivery commands to the pump to apply the algorithm's recommend therapy, and providing a means to monitor the system.; Up to 45 g of oral glucose via Gatorade
Other intervention name(s): Oral glucose
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 1 diabetes; closed loop insulin delivery systems; exercise; hypoglycemia
Occlusal Bite Force Changes After Placement of Stainless Steel Crowns in Children
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The aim of this study was to determine if restoring primary molars with SSCs would improve
      children's OBF.
    

Detailed description: 
      Occlusal bite force (OBF) is an indicator of the functional status of the masticatory system.
      The level of maximum occlusal bite force (MOBF) results from the combined action of the jaw
      elevator muscles modified by jaw biomechanics and reflex mechanisms. The measurement of OBF
      has been widely used in dentistry to provide useful data for the evaluation of jaw muscle
      function and activity as well as effectiveness of prosthetic therapy.

      Many indicators have been believed to assess the functional status of the masticatory system,
      such as body size, bite force, number of functional tooth units, and the occlusal contact
      area. Dental status formed with dental fillings, dentures, position and the number of teeth
      is an important factor in the value of the OBF.

      Many studies were conducted to evaluate the effect of dental caries on OBF. Tsai et al. found
      a negative correlation between MOBF and the number of decayed teeth. Su et al. reported that
      the overall tooth decay was not related to the strength of OBF. They suggested that the
      severity of tooth decay may be more important than the number of teeth exhibiting decay.

      Stainless Steel Crowns (SSCs) are considered the treatment of choice for severely decayed but
      restorable primary molars. A recent systematic review by Seale and Randall confirmed their
      previous work and reviews and appeared to continue to be supportive and in favor of SSCs.

      SSCs has been blamed for premature contact related discomfort in the first few weeks after
      placement of SSCs. Zee and Amerongen reported that premature contacting SSC restored teeth
      will equilibrate over time and return to pretreatment levels in 15 to 30 days.

      Several opinions have been reported by parents, children and dentists regarding the improved
      mastication efficiency after placement of the SSCs. However, the effects of SSCs placement on
      primary molars on OBF have not yet been investigated
    

Intervention name(s): Stainless Steel Crowns
Intervention type(s): Device
Intervention description(s): SSCs were placed on children's primary molars, and bite force was registered prior to the study, and periodically after the study.
Other intervention name(s): SSCs
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment