bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation Of Valaciclovir In Patients With Chickenpox
Condition: Varicella
MeSH terms: Chickenpox; Herpes Zoster
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the safety and efficacy, and the pharmacokinetics of aciclovir and
      valaciclovir in children with chickenpox following oral administration of valaciclovir, for
      the purpose of seeking approval of valaciclovir HCl for the treatment of chickenpox.
    


Intervention name(s): valaciclovir HCl granules
Intervention type(s): Drug
Intervention MeSH terms: Valacyclovir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chicken pox; varicella; VZV; pharmacokinetics
Belgian Pulmonary Function Study
Condition: Respiratory Symptoms
MeSH terms: Signs and Symptoms, Respiratory
Study type: Observational

Summary: 
      Pulmonary function tests including spirometry, lung volumes, measurements of resistance and
      diffusing capacity are essential in the diagnosis of several pulmonary diseases. These tests
      are an integral part of the diagnosis and treatment of lung diseases, but until now there is
      no clear evidence for the use of many of the pulmonary function tests because of a lack of
      adequate studies. The obscurity largely pertains to the conditions under which combinations
      of the various tests are indicated. Therefore the Belgian Thoracic Society, assembling all
      pulmonologists and the pneumology LOK/GLEM"s, will investigate this matter.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Caucasian outpatients with respiratory symptoms but without diagnosis
      
Keywords: Caucasian outpatients; undiagnosed respiratory symptoms; dyspnea; cough; sputum
A Pilot Clinical Trial on the Efficacy of Two Carnitine-Based Products on Muscle Function in Healthy Older Adults
Condition: Muscle Function
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates two L-Carnitine-based products on muscle function in healthy older
      adults (55 to 70 years old). These products are suspected to improve muscle function and
      possibly promote building of muscle mass. One third of the subjects will be on Carnipure
      Product 1, one third will be on Carnipure Product 2 and one third will be on placebo.
    


Intervention name(s): Carnipure Product 1; Carnipure Product 2; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Muscle function; L-Carnitine; Carnipure; DXA; anabolism; 6 minute walk; dynamometry; muscle biopsy
TMC125-TiDP35-C213: Safety and Antiviral Activity of Etravirine (TMC125) in Treatment-Experienced, HIV Infected Children and Adolescents
Condition: HIV-1
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and antiviral activity of etravirine in
      treatment-experienced human immunodeficiency virus (HIV) infected children and adolescents.
    

Detailed description: 
      The study design is a single arm treatment (all patients assigned to receive etravirine),
      open label (patients will know the identity of the treatments they are receiving) safety and
      antiviral activity of Etravirine (TMC125) in treatment-experienced, HIV infected children and
      adolescents 6 to 17 years of age. Etravirine is a new drug belonging to the NNRTI (a
      non-nucleoside reverse transcriptase inhibitor) drug class that slows down the growth of the
      human immunodeficiency virus (HIV). This drug has been tested for safety and effectiveness in
      adults, however, there is no data on the drug's long-term safety and antiviral activity in
      children and adolescents. This study will last for a maximum of 48 weeks. A total of 100
      ptients will receive etravirine tablets based on body weight and an investigator selected
      optimized background regimen (OBR) of at least 2 antiretrovirals (ARVs), consisting of a
      boosted protease inhibitor (PI) and nucleoside reverse transcriptase inhibitor(s) (NRTI[s]).
      Use of enfuvirtide is optional. Safety will be monitored throughout the study.
    

Intervention name(s): Etravirine (TMC125); Optimized background regimen (OBR)
Intervention type(s): Drug; Drug
Intervention description(s): Patients will be dosed by body weight , i.e. 5.2 mg/kg twice daily (b.i.d.) up to a maximum of 200 mg b.i.d. for 48 weeks.; An investigator-selected optimized background regimen (OBR) comprising of a low-dose ritonavir (rtv)-boosted protease inhibitor (PI) (either lopinavir [LPV], darunavir [DRV], atazanavir [ATV] or saquinavir [SQV]) in combination with nucleos(t)ide reverse transcriptase inhibitor(s) (N[t]RTIs) to be dosed according to the drugs individual package inserts for 48 weeks.
Intervention MeSH terms: Etravirine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV-1; TMC125-TiDP35-C213; TMC125-C213
A Study of ASP0367 in People With Kidneys That do Not Work Well and in Healthy People
Condition: Renal Impairment; Healthy Volunteers
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is for adults whose kidneys do not work well (renal impairment) and adults whose
      kidneys work normally. This study will provide more information on a potential new treatment,
      called ASP0367. The main aim of the study is to learn how ASP0367 is processed by the body in
      these different groups of people.

      This study will be in 2 parts. Part 2 will only happen if the results between the 2 groups
      are different in Part 1. In each part, people in the study will stay in a research unit for 6
      days and 5 nights. Later, they will return to the research unit for 1 check-up.

      In Part 1, people whose kidneys work normally and people whose kidneys work very poorly
      (severe renal impairment) can take part.

      If Part 2 happens, people whose kidneys work normally and people whose kidneys do not work
      well (mild or moderate renal impairment) can take part.

      In both parts of the study, people who can take part will be admitted to the research unit.
      The next day they will take tablets of ASP0367 just once. People will give blood and urine
      samples at various times during their stay. They will have their vital signs (heart rate and
      blood pressure) checked regularly. People will also have ECGs to check their heart rhythm.
      They will be asked if they have any medical problems. After 6 days, provided all the checks
      have been done and there are no medical problems, people in the study will leave the research
      unit.

      People will return to the research unit for 1 check-up. This will be between 9 and 11 days
      after their last blood sample was taken during their previous stay in the unit. The check-up
      will include a physical exam, a check of people's vital signs (heart rate and blood
      pressure), and blood tests. Also, people will have an ECG and be asked if they have had any
      medical problems.
    


Intervention name(s): Bocidelpar
Intervention type(s): Drug
Intervention description(s): Oral
Other intervention name(s): MA-0211, ASP0367
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Severe renal impairment; Moderate renal impairment; Mild renal impairment; ASP0367; Pharmacokinetics; Healthy Volunteers; MA-0211; Kidney function; Bocidelpar
Drug-Drug Interaction Study to Evaluate the Pharmacokinetics and Safety of CTX 4430 and Midazolam
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This drug-drug interaction study will assess the potential of CTX-4430 to induce CYP3A
      activity in healthy subjects.

      The study hypothesis is that midazolam (a sensitive, widely used CYP3A4 substrate) blood
      levels will not change after treatment with CTX-4430.
    


Intervention name(s): CTX-4430; Midazolam
Intervention type(s): Drug; Drug
Intervention MeSH terms: Midazolam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Drug Interaction
Computer Assisted Implant Surgery and Immediate Loading
Condition: Edentulous Jaws
MeSH terms: Jaw, Edentulous
Study type: Interventional

Summary: 
      Purpose: The aim of this study was to analyze the clinical and radiographic outcomes of 23
      edentulous jaws treated with 3D software planning, guided surgery, immediate loading and
      restored with Cad-Cam Zirconia and titanium full arch frameworks.

      Material & methods: This study was designed as a prospective clinical trial. Twenty patients
      have been consecutively rehabilitated with an immediately loaded implant supported fixed full
      prosthesis. A total of 120 fixtures supporting 23 bridges (8 mandible, 15 maxilla) were
      placed , 22 of which in fresh post extraction sockets. All the implants were inserted with an
      insertion torque of 35/45 Ncm. 117 out of 120 implants were immediately loaded the other 3
      were delayed loaded.

      Outcome measures were implants survival, radiographic marginal bone-levels and bone
      remodeling, soft tissue parameters and complications.
    


Intervention name(s): oral implants
Intervention type(s): Device
Intervention description(s): For all cases, the following surgical and prosthetic protocol was followed.:
Clinical examination
Radiological examination
Guided oral implants insertion
Immediate Prosthetic loading
Follow-up
Other intervention name(s): Oral implants Nobel Replace Tapered Groovy; Nobel Biocare AB, Goteborg, Sweden
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Computer assisted implant surgery,; Immediate loading,; CAD/CAM
Cerebral Reorganization in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The purpose of this study is to reveal the specific effects of computer-aided cognitive
      training on cerebral reorganization in schizophrenia
    

Detailed description: 
      Impairment in cognitive functions is one of the main symptoms in schizophrenia and is
      currently one of the challenges in the treatment of the disease. In this study we compare
      effects of two computer-aided training programs. One focused on auditory perception and
      processing as a basic ability underlying higher order information processing. The other
      training focus on facial affect discrimination and working memory. Both trainings are
      computer-aided and time-intensive, including up to twenty sessions within four weeks.
    

Intervention name(s): Brain Fitness & Brain Training- Posit Science; Facial Affect Training- FAT; Treatment as usual
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Computer aided cognitive program designed for intensive training of auditory perception, memory and attention; Computer-aided cognitive program designed for intensive training of facial affect discrimination, memory and attention; standard treatment protocol of schizophrenia ward
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Cognitive Training; Neuroplasticity; MEG; MATRICS
Interference With Cognitive Control by Transcranial Direct Current Stimulation
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      Insufficient cognitive control over emotional distracters is characteristic for major
      depressive disorder (MDD). Hypoactivation of the dorsolateral prefrontal cortex (dlPFC) is
      associated with this deficit. In this study the investigators assess the effect of a decrease
      of dlPFC activity in healthy subjects by cathodal transcranial direct current stimulation
      (tDCS) on cognitive control.

      In a double-blinded, balanced randomized, sham-controlled crossover trial the investigators
      determine the effect of a single-session of cathodal tDCS to the left dlPFC on cognitive
      control in healthy subjects. To assess the cognitive control the investigators use a delayed
      response working memory task (DWM)and an arithmetic inhibition task (AIT) with pictures of
      varying valence.
    


Intervention name(s): Cathodal transcranial direct current stimulation (tDCS); Sham transcranial direct current stimulation
Intervention type(s): Device; Device
Intervention description(s): Cathodal transcranial direct current stimulation (tDCS) 20min, 1mA, F3 (EEG 10/20), reference right M. deltoideus; Sham transcranial direct current stimulation (tDCS) 40s, 1mA, F3 (EEG 10/20), reference right M. deltoideus
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Study of HL-085 in NRAS Mutant Advanced Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a phase I/II, open-label, dose escalation study to evaluate tolerability, safety,
      pharmacokinetics and efficacy in patients with NRAS mutant advanced melanoma .
    


Intervention name(s): HL-085
Intervention type(s): Drug
Intervention description(s): HL-085 is one MEK inhibitor.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Melanoma; NRAS
A Comparison of Parenting Education Approaches for Adolescent Fathers
Condition: Adolescent, Parenting
Study type: Interventional

Summary: 
      This feasibility and acceptability study will compare in-person to web-based parenting
      education for adolescent fathers on the outcomes of parenting confidence and participation in
      parenting activities.
    

Detailed description: 
      This is a randomized feasibility and acceptability study using a block generator for
      randomization of participants aged 15 to 21 into either in-person parenting education or
      on-line parenting. Outcome measures include parenting self-efficacy and participation in
      daily parenting activities. Participants will take part in approximately twelve hours of
      parenting education, whether in-person or on-line. Recruitment flyers will be placed in two
      primary care clinics and a large regional hospital's Labor & Delivery and Postpartum
      (Mother-Baby) Units. Participants will seek out the opportunity to participate by calling the
      phone number or sending an e-mail to the investigators to learn more about the study and
      their potential participation. If participants meet eligibility criteria and elect to
      participate, baseline measurements will be completed after enrollment, with follow-up
      measures at one month and two months.
    

Intervention name(s): Parenting Education
Intervention type(s): Behavioral
Intervention description(s): Parenting education such as positive parenting interactions with their child, knowledge of developmental milestones and interactions with the child to support that development, as well as co-parenting skills will be provided either in-person or on-line to adolescent fathers
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Using a block randomization generator, participants will be randomized into either in-person or on-line parenting education that will take place over a two week period of time.
Masking: None (Open Label)
Primary purpose: Other
Telemedicine on Metabolic Control in Type 1 Diabetes Mellitus Andalusian Patients (PLATEDIAN)
Condition: Telemedicine
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      To assess the effect of a 6-month telemedicine program (DiabeTIC) in patients with type 1
      diabetes mellitus (DM1) and regular metabolic control (HbA1c <8%) in multi-dose insulin
      treatment (MDI) measured HbA1c vs. conventional medical care.
    

Detailed description: 
      The substitution of face-to-face visits for telematics visits has a similar effect on
      glycemic control (measured by HbA1c) in patients with DM1 treated with multiple daily doses
      of insulin (MDI) and regular metabolic control (HbA1c <8 %). It even saves costs and
      consumption of health resources, and improves the quality of life and satisfaction of
      subjects with DM1

      To evaluate the effect of a 6-month Diabetic platform on telemedicine in patients with DM1
      and regular metabolic control (HbA1c <8%) on MDI treatment in the following parameters:

      A) Glycemic control: Mean glycemia, number of mild hypoglycemia / week, number of severe
      hypoglycemia / 6 months, number of hyperglycemia greater than 250mg / dl / week, number of
      episodes of ketosis / 6 months, number of episodes of ketoacidosis / 6meses , Number of
      hospital admissions due to glycemic decompensation / 6 months.

      B) Glycemic variability: Standard deviation, mean amplitude of glycemic excursions (MAGE).

      C) Fear of hypoglycemia: scale FH-15. D) Quality of life: Diabetes Quality of Life
      Questionnaire (DQoL). E) Stress: DDS questionnaire.

      F) Costs and consumption of health resources:

      -Cost-effectiveness (HbA1C)
    

Intervention name(s): Telemedicine group; Conventional group
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 1 diabetes
Veın Imagıng Devıce And Vırtual Realıty
Condition: Pain, Acute; Emotional Distress; Fear; Anxiety State
MeSH terms: Acute Pain
Study type: Interventional

Summary: 
      The aim of this study was to evaluate the effect of a vein imaging device and virtual reality
      distraction on the success of peripheral intravenous catheter (PIC) placement, intervention
      duration, emotional appearance, pain, fear, and anxiety related to PIC intervention in
      children aged 4-10 years in a pediatric emergency unit.
    

Detailed description: 
      The children were divided into four groups: control group, vein imaging group, virtual
      reality group, and vein imaging and virtual reality group. The duration of the intervention
      and the number of PIC interventions performed on each patient were recorded. The children
      were assessed before and after the procedure using the Emotional Appearance Scale for
      Children. After the procedure, the Child Fear Scale and Child Anxiety Scale-State were used
      to evaluate the most painful moment experienced by the child during the procedure using the
      Wong-Baker FACES (WB-FACES) and Color Analog Scale.
    

Intervention name(s): vein viewer; virtual reality; vein viewer and virtual reality
Intervention type(s): Device; Device; Device
Intervention description(s): The PIC region was visualized with the help of the device, and the vein to which the intervention would be applied was determined.; The child watched the application by wearing virtual glasses during the PIC insertion; The PIC region was visualized with the help of the device, and the vein to which the intervention would be applied was determined.
The child watched the application by wearing virtual glasses during the PIC insertion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Immunotherapy for Recurrent Cervical Cancer Refractory to Platinum-based Chemotherapy
Condition: Recurrent Cervical Carcinoma; Persistent Advanced Cervical Carcinoma; Chemotherapy; Anti-PD-1 Antibody; Immunotherapy
MeSH terms: Carcinoma; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      For recurrent or persistent advanced cervical cancer patients, the first-line chemotherapy
      was based on platinum. However, if they were refractory to platinum-based chemotherapy, there
      were no other more effective medications or treatment. The marketing of anti-PD-1 antibody
      has provided an opportunity of curative management. This single arm, open, phase II trial
      would recruit 34 eligible patients. A combination of anti-PD-1 antibody camrelizumab and
      albumin-bound paclitaxel would be given for first 9 patients. If at least total 2 patients
      achieved complete or partial remission, or at least total 6 patients achieved complete or
      partial remission or stable disease, the same regimen would be given for rest patients. The
      primary end is overall response rate (ORR). The second ends include progression-free
      survival, overall survival, disease control rate, remission duration, and adverse events. A
      molecular testing, mainly consisting of genomic analysis, will be carried in the oncologic
      tissues.
    


Intervention name(s): A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel
Intervention type(s): Drug
Intervention description(s): A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel would be given for all patients:
Camrelizumab: 200 mg every time, every 3 weeks, which would be sustained until the appearance of disease progression on intolerable adverse events, and no more than 24 months
Albumin-bound paclitaxel: 200-300 mg every time, every 3 weeks, no more than 6 courses
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Antibodies
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Olmesartan Medoxomil in Stage 1 and 2 Essential Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      In patients naive to treatment or after a 2-week washout period for patients whose treatment
      was ineffective, the use of olmesartan was assessed in a 4-phase treatment scheme:
      monotherapy, addition of hydrochlorothiazide (2 phases), addition of amlodipine.
    


Intervention name(s): olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary
Intervention type(s): Drug
Intervention description(s): olmesartan medoxomil tablets,or olmesartan medoxomil/hydrochlorothiazide tablets, if necessary + amlodipine tablets, if necessary. All interventions are once-daily for 4 to 9 weeks
Intervention MeSH terms: Amlodipine; Hydrochlorothiazide; Olmesartan; Olmesartan Medoxomil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypertension; angiotensin II type 1 receptor blocker; olmesartan