bioihbjkbjnl/mcl2 huggingface dataset:
Comparative Evaluation Of 1.2% Atorvastatin and 1.2% Simvastatin Gel Local Drug Delivery And Redelivery In Chronic Periodontitis Subjects With Diabetes Mellitus: A Randomized Controlled Clinical Trial.
Condition: Chronic Periodontitis Wth Diabetes Mellitus
MeSH terms: Periodontitis; Chronic Periodontitis; Diabetes Mellitus
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Statins are specific competitive inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A
      (HMG-CoA) reductase, known for its hypolipidemic actions, possessing biologically significant
      anti-inflammatory and antioxidant properties, exerts anabolic effects on bone through
      expression of BMP - 2, have paved way in periodontal regeneration. The present study aims to
      evaluate and compare the efficacy of subgingivally delivered 1.2% Atorvastatin (ATV) and 1.2%
      Simvastatin (SMV) gel local drug delivery and redelivery systems as an adjunct to scaling and
      root planning (SRP) in chronic periodontitis (CP) subjects with diabetes mellitus(DM).
    

Detailed description: 
      Statins are specific competitive inhibitors of 3-hydroxy-3-methylglutaryl coenzyme A
      (HMG-CoA) reductase, known for its hypolipidemic actions, possessing biologically significant
      anti-inflammatory and antioxidant properties, exerts anabolic effects on bone through
      expression of BMP - 2, have paved way in periodontal regeneration. The present study aims to
      evaluate and compare the efficacy of subgingivally delivered 1.2% Atorvastatin (ATV) and 1.2%
      Simvastatin (SMV) gel local drug delivery and redelivery systems as an adjunct to scaling and
      root planning (SRP) in chronic periodontitis (CP) subjects with diabetes mellitus(DM). 120
      subjects with intrabony defects were divided into three groups;group 1- SRP plus 1.2% ATV ;
      group 2- SRP PLUS 1.2% SMV; and group 3- SRP plus placebo gel. Clinical and radiographic
      measurements were taken at baseline, at 6 months and respective gels were redelivered
      subgingivally in respective groups . Measurements were repeated again at 3 months i.e. 9
      months from baseline.
    

Intervention name(s): ATORVASTATIN; SIMVASTATIN; PLACEBO
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Scaling and Root Planing (SRP) followed by placement of atorvastatin gel; Scaling and Root Planing (SRP) followed by placement of simvastatin gel; Scaling and Root Planing (SRP) followed by placement of placebo gel
Other intervention name(s): ATV; SMV; inactive drug
Intervention MeSH terms: Atorvastatin; Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Revaccination With Influenza Vaccine GSK1247446A
Condition: Influenza; Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The protocol is designed to demonstrate the safety of influenza vaccine GSK1247446A after
      revaccination.
    

Detailed description: 
      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Intervention name(s): Influenza Vaccine GSK1247446A; Fluarix™
Intervention type(s): Biological; Biological
Intervention description(s): Single dose, Intramuscular injection; Single dose, Intramuscular injection
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; Influenza vaccine
Safety and Efficacy of Hoodia Gordonii for Treatment of Non Alcoholic Fatty Liver Disease (NAFLD)
Condition: Non-Alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical study is designed to evaluate the safety of oral administration of the medical
      food Hoodia to patients with non alcoholic fatty liver disease.

      Oral administration of Hoodia is common in many western world countries for appetite
      suppression and as a food supplement or medical food used for dietary purposes.

      Nonalcoholic steatohepatitis or NASH is a common, often "silent" liver disease which affects
      about 2%-5% of Americans. NASH is strongly associated with the metabolic syndrome, diabetes
      type-2 and obesity and can lead to cirrhosis, HCC, liver transplantation or death.This
      clinical trial has been designed to assess the safety of short term oral administration of
      Hoodia to patients with NASH.
    


Intervention name(s): Hoodia gordonii; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): PO administration of 1 Tab Hoodia gordoni extract per day.; PO Placebo pill
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hoodia gordoni; NASH; NAFLD
Feasibility Study of the ReVENT Sleep Apnea System
Condition: Obstructive Sleep Apnea (OSA)
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      This is a prospective, multi-center, single arm, feasibility study to evaluate the safety and
      effectiveness of the ReVENT Sleep Apnea System for the treatment of Obstructive Sleep Apnea.
    


Intervention name(s): ReVENT Sleep Apnea System
Intervention type(s): Device
Intervention description(s): The ReVENT Sleep Apnea System consists of minimally invasive biocompatible devices that are placed into the tongue base and palate of patients with obstructive sleep apnea
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      A single-arm, multi-center, clinical study to assess the safety profile of the Tandem t:slim
      X2 with Control-IQ system in children with T1D aged 2-6 years old under free living condition
    

Detailed description: 
      This clinical trial aims to demonstrate the safety of the Closed-Loop Control (CLC), also
      known as Artificial Pancreas (AP) named t:slim X2 with Control-IQ Technology and assess
      usability in a supervised setting for the treatment of type 1 diabetes (T1D) in young
      children (2-6 years old).
    

Intervention name(s): Tandem t:slim X2 with Control-IQ Technology + Dexcom G6
Intervention type(s): Device
Intervention description(s): Subjects will use the Tandem t:slim X2 with Control- IQ Technology and Dexcom G6 CGM to control their glycemia. The Tandem t:slim X2 with Control-IQ device is an automated insulin delivery pump that automatically adjusts insulin delivery to predicted and prevailing glucose levels, as measured by a Dexcom G6 continuous glucose monitor [CGM].
Other intervention name(s): Artificial Pancreas; Automated Insulin Delivery Device
Intervention MeSH terms: Insulin; Pancrelipase
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Artificial Pancreas (AP); Continuous Glucose Monitor (CGM); Closed Loop Control (CLC); Insulin Pump
Clinical Study to Test the Efficacy and Safety of ACYC to Treat Moderate to Severe Acne
Condition: Acne
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to compare the efficacy and safety and tolerability of
      ACYC Gel and vehicle in the treatment of subjects with Acne Vulgaris.
    

Detailed description: 
      The primary objective of this study is to compare the efficacy and safety and tolerability of
      ACYC Gel and vehicle in the treatment of subjects with Acne Vulgaris
    

Intervention name(s): ACYC; ACYC vehicle
Intervention type(s): Drug; Drug
Intervention description(s): ACYC active, topically applied to the face for 12 weeks; ACYC vehicle (placebo), topically applied to the face for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Acne
Behavioral Lifestyle Intervention Study (BLIS) in Patients With Type 2 Diabetes in UAE: A Randomized Controlled Trial in Real Life Setting
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The primary purpose of this study is to develop a behavioral lifestyle intervention and
      evaluate its effectiveness in improving the glycemic control in patients with type 2 diabetes
      in real life setting. This is because ambiguity still exists on the effectiveness of
      behavioral lifestyle interventions in routine clinical practice despite of the efficacy of
      large randomized controlled trials, suggesting the need for more research in this area.
    


Intervention name(s): Behvarioal lifestyle modification
Intervention type(s): Behavioral
Intervention description(s): A six months behavioral lifestyle program composed of 8 sessions; 4 individual consultations and 4 telephonic calls. The cognitive behavior theory (CBT) is the underpinning theory for the lifestyle intervention; hence CBT behavioral strategies like self monitoring and goal setting are used to improve compliance to healthy lifestyle practices
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cognitive behavior therapy; Lifestyle modification; HbA1c; Carbohydrates
Adherence to HU and HRQOL in Patients With Sickle Cell Disease: An Intervention Study Using HU-Go App
Condition: Sickle Cell Disease; Sickle B+ Thalassemia; Sickle Beta Zero Thalassemia; Sickle Cell Hemoglobin C
MeSH terms: Anemia, Sickle Cell; Thalassemia; Hemoglobin SC Disease
Study type: Interventional

Summary: 
      This project addresses three important research questions. First, adolescents and young
      adults (AYA) with sickle cell disease (SCD) and their parents/caregivers will be engaged to
      inform the (1) domains of health-related quality of life (HRQOL) most important to them, (2)
      frequency at which they are willing to complete them, and (3) other procedures related to the
      use, uptake and effect of the HU-Go app as a tool to improve hydroxyurea (HU) adherence.
      Second, this study seeks to utilize novel modern mobile technology using a multi-functional
      personalized platform to improve adherence to HU and measure HRQOL in youth with SCD, using
      NIH-endorsed PROMIS® measures, based on a conceptual model with predefined behavioral targets
      and mediators. Third, we plan to assess HRQOL changes and identify modifiable behavioral
      strategies that could serve as surrogates or predictors for HU adherence. This real-time
      feedback might empower self-directed changes in behavior that could improve adherence to HU.
    

Detailed description: 
      Aim 1: Identify the needs, desires, concerns, and expectations of AYA patients with SCD and
      their parents/caregivers that will guide implementation of a mHealth tool, HU-Go, designed to
      improve adherence to HU. We will conduct semi-structured interviews with patients and their
      parents/caregivers. Transcripts will be independently coded and thematic analysis will be
      conducted.

      Hypothesis 1: AYA patients with SCD and their parents/caregivers will identify specific
      features, content, and usability requirements of HU-Go.

      Aim 2: Assess the longitudinal relationship of HU adherence to HRQoL domains, including
      fatigue and depression. HU adherence will be measured using electronic pill bottles,
      self-report measures, laboratory markers, and medication possession ratio (MPR). HRQOL will
      be assessed using PROMIS® measures.

      Hypothesis 2: Low HU adherence is associated with impairment of HRQoL domains.

      Aim 3: Conduct a single-arm, pilot study to determine the effect size associated with
      improvement in HU adherence after using HU-Go for 12 weeks. Adherence will be measured using
      self-report measures, laboratory markers and MPR.

      Hypothesis 3: HU-Go will improve HU adherence by at least 20%.
    

Intervention name(s): HU-Go app
Intervention type(s): Other
Intervention description(s): A novel multifunctional mobile app (HU-Go) to improve adherence to hydroxyurea in patients with sickle cell disease
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
rhTPO Combining Rituximab Versus Low-dose Rituximab in Management of ITP
Condition: Purpura; Idiopathic Thrombocytopenic Purpura
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 3

Summary: 
      The project was undertaking by Qilu Hospital of Shandong University and other 13 well-known
      hospitals in China. In order to report the efficacy and safety of Recombinant Human
      thrombopoietin combining with Rituximab for the treatment of adults with refractory immune
      thrombocytopenia (ITP), compared to conventional Rituximab therapy.
    

Detailed description: 
      The investigators are undertaking a parallel group, multicentre, randomised controlled trial
      of 240 refractory ITP adult patients from 14 medical centers in China. One part of the
      participants are randomly selected to receive recombinant human thrombopoietin (given
      subcutaneously at a dose of 300 Units/kg for 14 consecutive days,following with a flexible
      dosage depending on platelet count until the 29th day), combining with rituximab (given
      intravenously at a dose of 100 mg weekly for 4 weeks, i.e. Day 1, 8, 15, 22; the others are
      selected to receive low-dose of rituximab treatment (given intravenously at a dose of 100 mg
      weekly, i.e. Day 1, 8, 15, 22). Platelet count, bleeding and other symptoms were evaluated
      before and after treatment. Adverse events are also recorded throughout the study. In order
      to report the efficacy and safety of the combination therapy compared to conventional
      rituximab therapy for the treatment of adults with refractory ITP.
    

Intervention name(s): rituximab; recombinant human thrombopoietin (rhTPO); Rituximab
Intervention type(s): Drug; Drug
Intervention description(s): patients in recombination treatment group take Rituximab( intravenously ,100 mg weekly for 4 consecutive weeks); in combination with Rh-TPO( subcutaneously , 300U/kg for 14 consecutive days,followed by flexible treating dosage so as to keep the platelet count above 50×10^9/L until the 29th day); patients in recombinant treatment group take Rituximab intravenously at 100 mg weekly for 4 consecutive weeks（Day 1,8,15,22)
Other intervention name(s): Recombinant Human Thrombopoietin; Recombinant Human TPO; rhTPO combine with Rituximab; Recombinant Human Thrombopoietin combine with Rituximab; Recombinant Human TPO combine with Rituximab
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Purpura; Idiopathic Thrombocytopenic Purpura
To Study the Efficacy and Safety of L. Plantarum UALp-05TM in Diarrhea- Predominant-irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome With Diarrhea
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional

Summary: 
      Several probiotic strains have shown beneficial outcomes in IBS patients, particularly among
      the Lactobacillus and Bifidobacterium genera, Lactobacillus plantarum (recently reclassified
      as Lactiplantibacillus plantarum) is a frequently isolated species of the healthy human GI
      tract that has been studied in numerous GI clinical studies, including for IBS.In the present
      study, the efficacy and tolerability of L. plantarum (UALp-05TM), will be evaluated in
      individuals with IBS-D.
    

Detailed description: 
      Several strains of Lactobacillus genus have previously been assessed in patients with IBS in
      multiple randomized controlled trials, demonstrating the efficacy of these strains in
      reducing IBS-related symptoms such as abdominal pain, distension and flatulence. We
      hypothesize the L. plantarum UALp-05 strain to benefit research participants by reducing pain
      severity, normalizing diarrhea predominant stool type and subsequently improving quality of
      life (QOL) standards. The current study with L. plantarum UALp-05, will include a lower dose
      of 1 billion CFU/day (considered a low dose among probiotic IBS studies) and a higher dose of
      10 billion CFU/ day (considered a mid-point dose among probiotic IBS studies) for a period of
      8-weeks.Each probiotic dosage group will be assessed individually in comparison to placebo.
    

Intervention name(s): Group I: L. plantarum UALp-05TM,; Group II: L. plantarum UALp-05TM,; Microcrystalline cellulose
Intervention type(s): Other; Other; Other
Intervention description(s): One capsule to be taken orally before lunch with a glass of water. In case the dose is missed, advise participant to take before dinner.; One capsule to be taken orally before lunch with a glass of water. In case the dose is missed, advise participant to take before dinner.; One capsule to be taken orally before lunch with a glass of water. In case the dose is missed, advise participant to take before dinner.
Other intervention name(s): Active; Active; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, double-blind, placebo-controlled, parallel group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
N-methyl Glycine (Sarcosine) for the Treatment of Obsessive Compulsive Disorder (OCD)
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Several lines of evidence implicate glutamatergic dysfunction in the pathophysiology of
      obsessive compulsive disorder (OCD). Sarcosine, also known as N-methylglycine, is an
      endogenous antagonist of glycine transporter-I (GlyT-I), which potentiates glycine's action
      at the glycine site of N-methyl-D-aspartate (NMDA) receptors. In this 10-week open-label
      trial, we examined the efficacy and safety of sarcosine treatment in OCD patients.
    


Intervention name(s): N-methyl glycine
Intervention type(s): Drug
Intervention description(s): staring from 500mg/day, increased by 500mg biweekly, up to maximin of 2000mg/day
Other intervention name(s): sarcosine
Intervention MeSH terms: Glycine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obsessive compulsive disorder; sarcosine; glycine transporter I; NMDA receptor
Treatment of Chronic Critical Limb Ischemia With G-CSF-mobilized Autologous Peripheral Blood Mononuclear Cells
Condition: Critical Limb Ischemia; Atherosclerosis; Ischemic Ulcer; Gangrene
MeSH terms: Atherosclerosis; Chronic Limb-Threatening Ischemia; Ischemia; Gangrene
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the safety and efficacy of G-CSF-mobilized
      autologous peripheral blood mononuclear cell injection to ischemic limbs of patients with
      critical limb ischemia.
    


Intervention name(s): Peripheral blood mononuclear cell
Intervention type(s): Biological
Intervention description(s): Peripheral blood mononuclear cell solution 59 cc will be injected to the gastrocnemius muscle of ischemic limb of patients with critical limb ischemia
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: critical limb ischemia; atherosclerosis; ischemic ulcer; rest pain; gangrene
Cardiovascular Disease and the Effects of a Cross-curricular Physical Activity Intervention
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of a cross-curricular physical
      activity intervention on cardiovascular disease risk factors in 11-14 year olds. The null
      hypothesis states that the intervention will have no effect on cardiovascular disease risk
      factors.
    

Detailed description: 
      Cardiovascular disease is the leading cause of mortality worldwide. Risk factors associated
      with cardiovascular disease including obesity, blood pressure and blood lipids have been
      shown to track from childhood through to adulthood. The prevalence of overweight and obesity
      for children (4-18 years) in the UK is reported to be 15 % and 4 % respectively. Furthermore,
      in comparison to England (2.9 %) obesity is more prevalent for those living in Scotland (7.6
      %) and Wales (6.5 %). Previous research from two Welsh secondary schools indicate overweight
      and obesity rates for boys and girls aged 12-13 to be even greater at 26 % and 38 %
      respectively. Further to this, 19 % were identified as having elevated total cholesterol
      (≥5.2 mmol/L).

      For many, overweight and obesity is the result of the combined effect of excess energy
      consumption and inadequate physical activity. Previous school-based physical activity
      interventions have demonstrated modest improvements to cardiovascular disease risk factors by
      implementing extra-curricular activities or improving current physical education curriculum.
      Few have attempted to increase physical activity using normally, class-room taught curriculum
      subjects. This study examines the impact of activity knowledge circuits to combat
      cardiovascular disease risk factors in 11-14 year old children.
    

Intervention name(s): Activity Knowledge Circuits
Intervention type(s): Other
Intervention description(s): The activity knowledge circuits were implemented, where in addition to regular physical education (PE) activity was increased by two hours a week over an 18-week period. Participants briskly walked 3200 m twice weekly during curriculum lessons (60 min). Short tasks, in line with current curriculum, were provided by subject teachers for participants to complete at stations set every 400 or 800 m. Crucially participants continued to follow national curriculum whilst exercising. Tasks designed by teachers lasted no longer than 60 seconds at each station. With the exception of PE, each curriculum subject delivered a total of four intervention lessons. Circuits were performed outdoors on school premises, with an indoor course of equal distance used during adverse weather conditions.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention