bioihbjkbjnl/mcl2 huggingface dataset:
The Efficacy of Lopinavir Plus Ritonavir and Arbidol Against Novel Coronavirus Infection
Condition: Coronavirus Infections
MeSH terms: Infections; Communicable Diseases; Coronavirus Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The study explores the efficacy of lopinavir plus ritonavir and arbidol in treating with
      novel coronavirus infection. As a result this study would provide evidence for the clinical
      usage of these drugs in the future .
    

Detailed description: 
      This is a phase IV, open-labelled, randomized controlled clinical trial. A total of 125 cases
      who are novel coronavirus positive are planned to be recruited. These cases are randomized
      into 3 groups: in group A（Standard treatment+lopinavir/ritonavir）, 50 cases are given
      ordinary treatment plus a regimen of lopinavir (200mg) and ritonavir (50mg) (oral, q12h,
      every time 2 tablets of each, taking for 7-14 days). In group B（Standard treatment+arbidol） ,
      50 cases are given ordinary treatment plus a regimen of arbidol (100mg) (oral, tid, 200mg
      each time, taking for 7-14 days). In group C（Standard treatment）, 25 cases are only given
      ordinary treatment. The observation duration is 21 days. Patients will be followed up at
      baseline (day 0) and day 2, 4, 7, 10,14, 21 after receiving indicated treatment. The primary
      observed indicators include viral nucleic in acid nose / throat swab, body temperature,
      respiratory rate, oxygen saturation of blood, chest imaging. The secondary observed
      indicators include but not limited to blood pressure, heart rate, blood routine test, liver
      and kidney function, myocardial enzyme, flow cytometry classification and counting,
      cytokines, other infection indicators, conditions and parameters of auxiliary respiration,
      the total days in hospital, exacerbation and mortality.
    

Intervention name(s): Lopinavir and Ritonavir Tablets; Arbidol
Intervention type(s): Drug; Drug
Intervention description(s): As indicated in arm/group descriptions; As indicated in arm/group descriptions
Other intervention name(s): Kletra
Intervention MeSH terms: Ritonavir; Lopinavir
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 125 patients are randomized in 3 groups (2:2:1). In group A(Standard treatment+lopinavir/ritonavir) , 50 cases are given ordinary treatment plus a regimen of lopinavir (200mg) and ritonavir (50mg) (oral, q12h, every time 2 tablets of each, taking for 7-14 days). In group B (Standard treatment+arbidol), 50 cases are given ordinary treatment plus a regimen of arbidol (100mg) (oral, tid, 200mg each time, taking for 7-14 days). In group C (Standard treatment）, 25 cases are only given ordinary treatment.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Coronavirus infection; Lopinarvir plus ritonavir; Arbidol; Efficacy
A Safe Environment for Every Kid (SEEK) I
Condition: Child Abuse
Study type: Interventional

Summary: 
      This study aims to enhance pediatric primary care to make it more responsive to psychosocial
      needs facing many families. We hypothesized that by identifying and addressing certain
      problems, such as depressed mothers, parental drug use, and domestic violence, we would help
      decrease child abuse and neglect.
    

Detailed description: 
      This study aims to enhance pediatric primary care to make it more responsive to psychosocial
      needs facing many families. We hypothesized that by identifying and addressing certain
      problems, such as depressed mothers, parental drug use, and domestic violence, we would help
      decrease child abuse and neglect.

      The first step was to train pediatric residents on the importance of addressing the targeted
      problems. Then, we developed a brief screening tool to use when children under six years came
      in for the regular checkups. Parents would complete this while waiting for their doctor.
      Finally, the doctor and/or social worker would try address any problems the parent
      identified.
    

Intervention name(s): Enhanced pediatric primary care; Standard pediatric primary care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Residents received special training to address targeted psychosocial problems. Parents bringing in children (0 - 5 years) completed a screening questionnaire and gave this to their doctor. The resident briefly assessed the identified problems and helped address them. A social worker was present to assist.; Residents did not receive special training on the targeted psychosocial problems. They did not use the parent screening questionnaire, and they did not have a dedicated social worker.
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Pediatric residents were trained to screen for and help address prevalent psychosocial problems, such as parental depression and substance abuse, that are risk factors for child maltreatment (CM). The SEEK model included a project social worker and use of community resources.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Child maltreatment; Physician education; Prevention
Effects of Coffee Consumption on Glucose Metabolism
Condition: Healthy
Study type: Interventional

Summary: 
      Epidemiological studies have shown an inverse association between coffee consumption and risk
      of type 2 diabetes mellitus (T2DM). However the experimental studies that analysed the
      mechanisms are limited.

      This project aims to assess the effects of coffee consumption on glucose metabolism, using
      stable isotope tracer (13C-glucose) to explain the possible metabolic mechanisms involved on
      the reduced risk for T2DM.
    

Detailed description: 
      This is a crossover randomized clinical trial that has been studying 14 male healthy young
      adults, who were enrolled five treatments: coffee with sugar, coffee without sugar,
      decaffeinated coffee without sugar and two controls (water with and without sugar).

      The stable isotope minimal model protocol with oral glucose administration (Oral Dose
      Intravenous Label Experiment - ODILE) was performed. The use of ODILE methodology permits
      separation of the glucose absorbed and removed from the circulation increasing the accuracy
      and the effectiveness of glucose uptake and insulin sensitivity (Bluck et al., 2006).
    

Intervention name(s): Coffee with Sugar; Coffee without Sugar; Decaffeinated Coffee without Sugar; Water with Sugar; Water without Sugar
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): 300mL of Coffee with 30g of Sugar; 300mL of Coffee without Sugar; 300mL of Decaffeinated Coffee without Sugar; 300mL of Water with 30g of Sugar; 300mL of Water without Sugar
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Coffee; Glucose; Insulin; Diabetes; Type 2 Diabetes Mellitus
Pharmacodynamic and Pharmacokinetic Dose Ranging Study of Tiotropium Bromide Administered Via Inhalation Solution in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      Pharmacodynamic and Pharmacokinetic Dose Ranging Study of Tiotropium Bromide Administered Via
      Inhalation Solution in Patients With Chronic Obstructive Pulmonary Disease (COPD).
    


Intervention name(s): GSP304 (tiotropium bromide) Inhalation Solution; GSP304 Placebo Inhalation Solution; Spiriva® Respimat® inhalation spray
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Once daily (QD) oral inhalation using a nebulizer; Once daily (QD) oral inhalation using a nebulizer; Once daily (QD) oral inhalation
Intervention MeSH terms: Bromides; Pharmaceutical Solutions; Tiotropium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Determine the Effect of AZD3161,Injected Intradermally, on Quantitative Sensory Testing Variables in Normal and Ultraviolet-C (UVC) Exposed Skin in Healthy Volunteers
Condition: Peripheral Neuropathic Pain; Nociceptive Pain
MeSH terms: Neuralgia; Nociceptive Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effect of AZD3161 on mechanical pain
      sensitivity and axon reflex flare in normal and ultraviolet C irradiated skin.
    


Intervention name(s): AZD3161; Lidocaine; AZD3161 Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose, intradermal injection; Single dose, intradermal injection
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Allodynia; hyperalgesia; paresthesia
A Dose Range Finding Study With Open-Label Extension to Evaluate the Safety of Oral LMI070/Branaplam in Early Manifest Huntington's Disease
Condition: Early Manifest Huntington Disease
MeSH terms: Huntington Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is the first study of branaplam in adults with Huntington's Disease (HD) to determine
      the correct dose required to lower mutant huntingtin protein (mHTT) levels in the
      cerebrospinal fluid (CSF) to a degree expected to be efficacious over longer periods of time.
    

Detailed description: 
      This study is a randomized, double-blind, placebo-controlled study which will be conducted in
      approximately 75 early manifest HD participants.

      After screening and baseline assessments are completed, participants will enter the Core
      Treatment Period which is double-blinded and placebo-controlled. The Core Treatment Period
      includes a Dose Range Finding (DRF) period of 17 weeks, followed by a Blinded Extension
      period of up to 53 weeks. Three cohorts will be enrolled in the Core Treatment Period, and
      data from each cohort will be evaluated for efficacy and safety before proceeding to a new
      cohort with a higher dose. The Core Treatment Period will serve to evaluate the safety,
      tolerability, pharmacokinetic(s) (PK) and pharmacodynamic(s) (PD) and to find the best
      dose(s) to use in future studies.

      After the dose(s) is determined at the end of the Core Treatment Period, participants will
      roll over into the Open Label Extension (OLE) and will be given branaplam for approximately 1
      year and attend clinic visits every 4 weeks. At the end of the OLE, the study may be amended
      to provide open-label branaplam beyond 1 year or a separate extension study may be initiated.
    

Intervention name(s): Branaplam; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): messenger ribonucleic acid (RNA) splicing modifier; Matching placebo oral solution once weekly
Other intervention name(s): LMI070
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study design uses a staggered cohort approach, allowing safety and tolerability of lower doses to be assessed before randomizing subjects to higher doses. At the time of the Cohort Gating Assessments (CGAs), all available data will be reviewed from a safety and dose finding perspective by an independent Sponsor team to support the decision to open the next cohort. The independent Data Monitoring Committee (DMC) will review the data separately. The decision to open a new cohort will be made by the Sponsor in consultation with the DMC.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Early Manifest; Huntington Disease; Branaplam; LMI070; Dose Range Finding; Safety; HD; mHTT; Pharmacokinetics; oral; Adult
Clinical and Radiographic Evaluation of Resin Endocrown as Long Term Interim Restoration Versus Stainless Steel Crown for Endodontically Treated First Permanent Molar in Children: Randomized Controlled Pilot Study.
Condition: Dental Caries in Children
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      management of endodontically treated first permanent molar with deep dental caries is one of
      the challenging procedure that the operator face. Using resin endocrown or stainless steel
      crown restoration to make comparison which one is more successful in children.
    

Detailed description: 
      Diagnostic procedure:

      Diagnosis of the cases will be performed according to guidelines of AAPD 2017 for treatment
      of irreversible pulpitis and necrotic pulp therapy in mandibular first permanent molar .
      Preoperative periapical radiograph will be taken

      Intra operative procedure:

      Local anaesthesia administration using articaine 4% with epinephrine 1:100000. Rubber dam
      application and access cavity preparation will be established using a sterile bur. Root Canal
      Treatment will be done and then the dental orifices of the pulp chamber will be sealed using
      a flowable composite.

      The immediate postoperative radiograph will be done to reveal optimal root canal treatment.

      In the intervention group:

      The preparation of cavity design will be as following:

      Preparation of occlusal surface will be done with wheel stone to create 2 mm occlusal
      clearance; the occlusal surface will be prepared flat to create a butt-joint. The junction
      between the occlusal and mesial cavity will be rounded to produce cervical side walk. •
      Divergence of the inner cavity walls will be obtained using a tapered stone with a rounded
      end (TR- Dia Bur Mani).

      Impression will be taken for the prepared tooth structure using addition silicone material
      (Elite HD Zermach, Italy), stone model will be poured for fabrication of endocrown to allow
      for blockage of any undercuts in the pulp chamber cavity. Finished final endocrown
      restoration will be cemented in place using self-adhesive universal dual cured resin cement
      (rely X Unicem, 3M, USA).

      In the control group tooth preparation will be made as follow:

      By reducing mesial, distal and occlusal surface. The crown margin will be placed just
      apically to the gingival margin and carefully adjusted to give an accurate fit in this
      region. The crown will be cemented with glass ionomer cement.

      Follow up:

      Clinical and evaluation will be performed at 1 st week, 3, 6, 9 and 12 months. Radiograph
      evaluation will be performed at, 1 st week, 6 and 12 months
    

Intervention name(s): Endocrown "composite".
Intervention type(s): Other
Intervention description(s): It is a type of restoration has been shown a great success in adult and recently has been suggested for children
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Age-related Skin Changes and Instrument Reliability Using Clinical Probe Measurements and Imaging Modalities
Condition: Age-related Skin Changes
Study type: Observational

Summary: 
      To evaluate the reliability of different non-invasive skin probe measurements.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        200 subjects will be included, with at least 25 subjects per group
Feasibility Study: Evaluation of the Ulthera® System for Treatment of the Knees
Condition: Skin Laxity
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      Enrolled subjects will receive one bilateral Ulthera® treatment on the knees. Up to 30
      subjects will be enrolled. Study photos will be obtained prior to study treatment,
      immediately following study treatment, and at each post-treatment follow-up visit. Follow-up
      visits will occur at 90 and 180 days post-treatment.
    

Detailed description: 
      This pilot study is a prospective, single-center clinical trial of the Ulthera® System for
      treating skin laxity on the knees. Global Aesthetic Improvement Scale scores and Patient
      Satisfaction questionnaires will be obtained at each follow-up visit.
    

Intervention name(s): Ulthera® System
Intervention type(s): Device
Intervention description(s): Focused ultrasound energy delivered below the surface of the skin
Other intervention name(s): Ultherapy™ treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Skin laxity; Knees
A Safety and Efficacy Study of NicaPlant® in Aneurysmal Subarachnoid Haemorrhage Patients Undergoing Aneurysm Clipping
Condition: Aneurysmal Subarachnoid Hemorrhage
MeSH terms: Subarachnoid Hemorrhage; Aneurysm; Hemorrhage
Study type: Interventional
Phase: Phase 2

Summary: 
      This study of NicaPlant® is conducted in patients who have a subarachnoid haemorrhage.
      Patients will be randomized in two treatment groups. Both groups will receive the standard of
      care and the investigational group will receive in addition NicaPlant®. NicaPlant® is tested
      to reduce the long-term complications of aneurysmal subarachnoid haemorrhage (aSAH).
    

Detailed description: 
      This is a safety, tolerability, efficacy and pharmacokinetic study of NicaPlant® in
      subarachnoid haemorrhage patients involving two treatment groups. Both treatment groups will
      receive standard of care and patients randomised to the investigational group will receive in
      addition NicaPlant® .

      NicaPlant® is a nicardipine modified-release formulation. It is presented in the form of a
      rod-shaped implant with a 4 mg nicardipine load. Following aneurysm clip ligation, 10
      NicaPlant® implants will be placed into the basal cisterns in direct contact with the exposed
      cerebral blood vessel walls.
    

Intervention name(s): Nicardipine; Standard of care
Intervention type(s): Drug; Other
Intervention description(s): 10 NicaPlant® implants releasing 4 mg nicardipine each.; Both arms receive the usual standard of care.
Other intervention name(s): NicaPlant®
Intervention MeSH terms: Nicardipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: NicaPlant; Nicardipine
The Effect of a Cranberry Beverage on Intestinal Permeability and Gastrointestinal Function in Generally Healthy Adults
Condition: Intestinal Permeability; Gastrointestinal Function
Study type: Interventional

Summary: 
      In this double blind, crossover study participants will consume a cranberry beverage and a
      cranberry-flavored beverage for 2 weeks each. Gut permeability will be assessed weekly using
      aspirin and food-grade sugar molecules. Participants will be asked to provide urine, blood,
      saliva and stool samples to assess gut permeability and microbial communities. No change in
      permeability to the small sugar probes is anticipated with the cranberry beverage
    

Detailed description: 
      Obesity, stress, liver disease, alcoholism, diabetes, and autoimmune diseases in humans or
      animal models are associated with altered intestinal permeability; consequently, maintenance
      of the gastrointestinal barrier is an emerging area of interest. The purpose of this
      randomized, double-blind, controlled crossover study is to compare the difference between the
      change from baseline in gastroduodenal permeability after drinking a cranberry or control
      beverage for two weeks. Gastroduodenal permeability will be assessed following aspirin
      challenge by measuring urinary sucrose in the 0 to 5-hour urine collection after differential
      sugar probes are consumed. Urine will be collected for an additional 19 hours (24 hours
      total) to assess whole gut permeability. A 4-week washout period will separate the
      interventions. Stool and fasting blood and saliva samples will be obtained before and during
      the intervention periods to assess fecal microbial communities and markers of intestinal
      barrier, immune function and oxidative stress. It is anticipated that cranberry juice will
      selectively increase intestinal Akkermansia bacteria, reduce markers of inflammation and
      oxidative stress, increase mucosal immunity, and protect the gastroduodenal barrier from an
      aspirin challenge.
    

Intervention name(s): Cranberry Beverage; Control Beverage
Intervention type(s): Other; Other
Intervention description(s): The cranberry beverage will provide 50 kcals and 4.0 grams of fiber per day from whole milled cranberries, water, cranberry natural flavor and sucralose.; The control beverage will provide 50 kcals per day and is a color, taste matched sugar sweetened beverage formulated with water, sucrose, citric acid, cranberry natural flavor, malic acid, xanthum gum, sucralose and artificial color (red 40, blue 1).
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A randomized, double-blind, placebo-controlled crossover in which participants receive one of the study beverages (cranberry or cranberry-flavored) for a 2-week intervention period each will be used.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Non Ablative Fractional Laser Treatment of Burn Scars
Condition: Burn Scars
MeSH terms: Cicatrix; Burns
Study type: Interventional

Summary: 
      BACKGROUND: Increasing evidence appears for non-ablative fractional laser (NAFL) to remodel
      mature burn scars.

      OBJECTIVES: To investigate long-term clinical and histological appearance of mature burn
      scars after NAFL-treatment.

      HYPOTHESIS: That NAFL can modulate mature burn scars with subsequently improved cosmetic and
      functional appearance.

      METHODS: Study patients with burn scars at trunk or extremities. Side-by-side test areas are
      randomized to three monthly 1,540 nm NAFL-treatments or control, followed by blinded
      evaluations at 1, 3, and 6 months using mPOSAS (modified Patient and Observer Scar Assessment
      Scale; 1 = normal skin, 10 = worst imaginable scar).
    


Intervention name(s): non-ablative fractional laser; control
Intervention type(s): Radiation; Other
Intervention description(s): 3 treatments with 4-6 weeks interval; observation, comparison to laser-treated area
Other intervention name(s): non-ablative fractional er:glass laser; 1,540 nm laser treatment; observation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Burns; Non-ablative fractional laser; scar texture; histology; laser treatment; erbium:glass laser; meshed skin-grafts; photothermolysis; skin