bioihbjkbjnl/mcl2 huggingface dataset:
Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "AG NPP709 Syrup"
Condition: Acute Upper Respiratory Tract Infections; Bronchitis
MeSH terms: Infections; Respiratory Tract Infections; Bronchitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess therapeutic confirmation of AG NPP709 syrup to
      evaluate the safety and efficacy in patients with acute upper respiratory tract infection and
      chronic inflammatory bronchitis.
    


Intervention name(s): AG NPP709syrup
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: acute upper respiratory tract infection, chronic inflamatory bronchitis
Ozone Therapy in Endodontic Practice, in Vivo Study
Condition: Primary Apical Periodontite
Study type: Interventional
Phase: Phase 2

Summary: 
      The ozone therapy has been coming up as a new therapeutic modality. Medicine has been
      practicing since XIX century and counted great results. It is indicated for the treatment of
      260 different pathologies. The researches in Dentistry has showed promising results,
      indicating a wide spread action in whole dental specialties. The great oxidative power of
      ozone provides a great antimicrobial effect and it increases the adenosine triphosphate (ATP)
      synthesis that can be considered as a general improvement of the cell metabolism, which can
      potentize the repair process. Thus, these facts justify the present study which will assess
      the increase of speed of apical periodontite repair.
    


Intervention name(s): Ozone; Control (no last irrigation); Aqueous Ozone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Regular endodontic protocol preconized by University of Sao Paulo. Root canal irrigation with 1% Sodium Hypochlorite associated to Endo PTC (10mL), final irrigation with EDTA-T 17% remaining for 3 minutes. After a last foaming with ozone gas (Philozon, Santa Catarina, Brazil) at 40mg/L concentration.; Regular endodontic protocol preconized by University of Sao Paulo. Root canal irrigation with 1% Sodium Hypochlorite associated to Endo PTC (10mL), final irrigation with EDTA-T 17% remaining for 3 minutes.; Regular endodontic protocol preconized by University of Sao Paulo. Root canal irrigation with 1% Sodium Hypochlorite associated to Endo PTC (10mL), final irrigation with EDTA-T 17% remaining for 3 minutes. A last irrigation with 10mL of ozonated water at 40mg/mL concentration
Other intervention name(s): Group 2; Group 1; Group 3
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Efficacy and Safety of Injection With VINCI Plus Hyaluronic Acid Filler
Condition: Nasolabial Fold Improvement
Study type: Interventional

Summary: 
      This clinical trial is intended to evaluate the efficacy and safety of injection with VINCI
      Plus as compared to Restylane-L® in correction of nasolabial fold.
    


Intervention name(s): VINCI Plus; Restylane-L
Intervention type(s): Device; Device
Intervention description(s): VINCI Plus 1ml injected into wrinkle treatment area; Restylane-L injected into wrinkle treatment area
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Investigational Device (VINCI Plus); Correction of nasolabial fold; Wrinkle improvement; Wrinkle correction
The Effect of Tendon Tears on Lateral Epicondylitis
Condition: Lateral Epicondylitis; Tennis Elbow; Tendon Tear
MeSH terms: Tennis Elbow
Study type: Observational

Summary: 
      Common extensor tendon (CET) tears that can be detected with ultrasonography (US) may be
      associated with worsening clinical and other ultrasonographic parameters in patients with LE.
      In this retrospective evaluation of patients with lateral epicondylitis (LE), the effect of
      common extensor tendon (CET) tears revealed by ultrasonography (US) with demographic,
      clinical, and other US findings was investigated.
    

Detailed description: 
      The files of 227 patients with LE who applied to Dokuz Eylül University Faculty of Medicine,
      Department of Physical Medicine and Rehabilitation Clinic and met the inclusion and exclusion
      criteria were reviewed retrospectively.

      The demographic characteristics of the patients were recorded.

      First of all, common extensor tendon tears, if it existed, were demonstrated with
      ultrasonography. Then, primary and secondary outcome measures were performed.

      Maximum tendon thickness measurements (capitellar - radiocapitellar) and the presence of bone
      abnormality were detected with ultrasonography of the lateral epicondyle region of the
      humerus.

      The VAS was used to assess pain and was evaluated separately for pain at rest (VAS-rest), at
      night (VAS-night), and during ADL (VAS-ADL).

      Force was applied on the lateral epicondyle using a standard pressure algometer (Baseline®)
      to evaluate the patient's sensitivity to pain. The pressure at which the patient first felt
      pain and the average value in kg/cm2 (repeated three times) were recorded.

      PRTEE consists of two sub-sections (pain and function): the severity of pain in the elbow and
      functional deficiencies. The Turkish version of the PRTEE questionnaire was used

      The hand dynamometer (JAMAR®) was used to assess the hand grip strength. The patient was
      positioned with sitting, shoulder adduction, elbow 90° flexion, and forearm in a position
      between supination and pronation. The average value in kilogram-force (repeated three times).
      Between repeated measures 1-minute resting, periods were given.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The files of 227 patients with LE who met the inclusion and exclusion criteria were
        reviewed retrospectively.
      
Keywords: Lateral Epicondylitis; Tennis Elbow; Extensor Tendon; Tendon Tear; Ultrasonography
Premenstrual Dysphoric Disorder and Antiepileptic Drugs
Condition: Epilepsy
MeSH terms: Epilepsy; Premenstrual Dysphoric Disorder
Study type: Observational

Summary: 
      This study is being done to determine if there are differences in mood during the menstrual
      cycle among women with epilepsy who take various different antiepileptic drugs and women
      without epilepsy.
    

Detailed description: 
      Participants will be given informed consent during the initial study visit. We will gather
      information about their seizure disorder and medications and provide them with instructions
      and a form that they will complete daily for two months (two menstrual cycles). During the
      third week of each menstrual cycle, they will be asked to return once to provide a blood
      sample.
    

Intervention name(s): Lamotrigine; Levetiracetam; Carbamazepine; No Intervention
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): Subjects had at least 3 months on a stable dosage of lamotrigine monotherapy.; Subjects had at least 3 months on a stable dosage of levetiracetam monotherapy.; Subjects had at least 3 months on a stable dosage of carbamazepine monotherapy.; No intervention was given
Other intervention name(s): Lamictal; Keppra; Tegretol
Intervention MeSH terms: Lamotrigine; Carbamazepine; Levetiracetam
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Three regional epilepsy centers
      
Biospecimen description: 
      serum
    
Keywords: epilepsy; lamotrigine; levetiracetam; carbamazepine; phenytoin; lamictal; keppra; tegretol; carbatrol; dilantin
Effects of Peritendinous Corticosteroid Injections, Eccentric Training and Heavy Slow Resistance Training in Patellar Tendinopathy
Condition: Patellar Tendinopathy / Jumpers Knee
MeSH terms: Tendinopathy
Study type: Interventional

Summary: 
      We will investigate the effect of peritendinous corticosteroid injections, eccentric training
      and heavy resistance training in male patellar tendinopathy patients. The purpose is to
      compare the clinical effect of these three treatments in a randomised controlled trial. Also
      we wish to investigate the treatment mechanisms responsible for the effectiveness of the
      three treatments.
    

Detailed description: 
      3 interventions groups as described above (n=13 in each group) 12 weeks intervention period.
      Clinical assessments before and after intervention: VAS, VISA, Tendon thickness, Doppler us
      activity.

      Before and after intervention tendon biopsies will be taken and analyzed for crosslinks and
      fibril diameter. Also tendon mechanical properties will be measured. Tendon and muscle
      structural properties will be measured with MRI.

      Treatment satisfaction will be stated after intervention period.
    

Intervention name(s): peritendinous corticosteroid injections; eccentric decline squat training; heavy slow resistance training
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): 1 ml of40mg/ml methylprednisolone acetate at 0 and 4 weeks. 2 week observational; eccentric decline unilateral squats performed twice daily. for 12 weeks; Heavy slow resistance training for knee extensors. 3/week. total of 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Dose-Proportionality and Food Effect Study of TNX-102 SL
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a single center, single-dose, randomized, open-label, 3-period, crossover,
      dose-proportionality and food-effect study.
    


Intervention name(s): TNX-102 SL
Intervention type(s): Drug
Intervention description(s): Subjects will place TNX-102 SL sublingual tablets under the tongue until dissolved, and not to crush or chew them
Other intervention name(s): cyclobenzaprine HCl
Intervention MeSH terms: Cyclobenzaprine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Development, Optimization, Efficiency of the Interface System of Communication and Control of the Environment
Condition: Handicaps Physical
Study type: Observational

Summary: 
      The objective of this project is the realization of tests at home and in Hospitals or
      Functional Rehabilitation for the improvement of the communication with the family and
      medical entourage, the facility of the emotional expression, the evaluation of the pain, the
      control of home automation to increase their autonomy, facilitated their reintegration at
      home. The work is the last step of the research program started in 2009, with the
      optimization of the installation of the system, the improvement of physical and computer
      ergonomic aspects and the development of dedicated interfaces according to the type of
      disability and needs. of each one.

      A work upstream of the definition of specifications taking into account the medical
      constraints was realized and the actions of improvement of the models, the algorithms, the
      robustness and the effectiveness of the treatment are in progress . The specific adaptation
      to concrete cases should lead to a system that allows 90% of the population of people with
      disabilities to exploit the system and significantly improve their level of communication,
      autonomy and in fact their daily lives.
    


Intervention name(s): Help to use the Interface System of Communication and Control of the Environment
Intervention type(s): Other
Intervention description(s): the occupational therapist and the ergonomics engineers at the rate of 4 sessions per patient for periods of 2 to 3 hours help patient to use use the Interface System of Communication and Control of the Environment
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with severe disabilities either of traumatic origin or of neurological origin or
        Patients over 55 with loss of autonomy.
Treatment Trial Evaluating Long Acting Insulin in Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients with type 1 diabetes trained in multiple daily insulin injection were treated with
      two diffferent kinds of long acting insulin preparations. The two insulin preparations were
      glargine and ultralente insulin. Patients were randomized to receive one of the two insulin
      preparations for the first 4 months followed by the second preparation for a further four
      months. Short acting insulin used was the same during both periods. We found that glargine
      insulin was better than ultralente insulin in our study.
    

Detailed description: 
      Multiple daily insulin injection (MDI) programs are commonly accompanied by considerable
      glycemic variation and hypoglycemia. In order to determine whether use of insulin glargine as
      a basal insulin would result in comparable HbA1c with less glycemic variation and
      hypoglycemia than ultralente insulin, 22 individuals with type 1 diabetes, experienced with
      MDI, and a HbA1c of <7.8 % were randomized, to receive either glargine or ultralente as the
      basal insulin for 4-months. Aspart insulin was used as the prandial. Physicians providing
      insulin dose adjustment advice were masked to the type of basal insulin. Treatment with
      glargine resulted in lower mean HbA1c, less nocturnal variability , and less hypoglycemia
      primarily due to less daytime hypoglycemia (p=0.002). On the other hand, serious hypoglycemia
      and average glucose concentration measured with continuous glucose monitoring system (CGMS)
      did not differ. We conclude that, while use of either ultralente or glargine as a basal
      insulin can result in excellent glycemic control, treatment with glargine is associated with
      slightly but significantly lower HbA1C, with less nocturnal glycemic variability and less
      hypoglycemia.
    

Intervention name(s): Basal insulin
Intervention type(s): Drug
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Treatment
Effect of Customized Healing Abutment on Soft Tissue Alterations Around Immediate Implant Placements With or Without Bone Graft Versus Connective Tissue Graft
Condition: Customized Healing Abutment Bone Grafts Connective Tissue Graft Immediate Implant Placement
Study type: Interventional

Summary: 
      Dimensional changes, including the loss of labial soft tissues and midfacial gingival
      recession, seem to be inevitable following immediate placement. The clinical relevance of
      this study is proposing a treatment modality namely customized healing abutment with
      immediate implant placement that is proposed to minimize and control midfacial gingival
      recession and support buccal soft tissue contour, and maintain long term stability of these
      tissue, which might enhance the esthetics
    

Detailed description: 
      Tooth extraction is followed by ridge alteration and soft tissue collapse and recession.
      Different strategies were proposed to limit this collapse however, the ability of these
      techniques to mimic the original soft tissue level and to maintain long term stability is
      unclear (Slagter et al., 2014). Using customized contoured healing abutments at the time of
      immediate implant placement is a treatment modality to improve esthetics by maintaining the
      soft tissue level and contour (Ruales-Carrera et al, 2019, Perez et al, 2020). Using
      connective tissue grafts has been suggested to enhance and maintain soft tissue stability,
      however, the effect of the combined procedures for maintenance of the soft tissue morphology
      compared to customized healing abutments alone remains unclear (Atieh et al, 2019).
    

Intervention name(s): Connective tissue graft /Bone graft/ Customized HA
Intervention type(s): Procedure
Intervention description(s): Soft tissue management and augmentation
Other intervention name(s): Customized Healing abutment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled clinical trial, parallel groups, three-arm, superiority trial with 1:1:1 allocation ratio.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Language Environment in Children With Cochlear Implants
Condition: Language Development
Study type: Interventional

Summary: 
      The Language Environment Analysis (LENA) system is a specific tool for the language
      environment analysis. Children aged from 18 months to 6 years old, with cochlear implants
      (CIs), wear an electronic device during a day and their language interactions are registered.
      Then the investigators can analyze with a specific software four different parameters (adult
      words, conversational turns, child vocalizations and media exposure) and compare them to the
      language ability of the children assessed by a speech therapist. With the results, the speech
      therapist can advise the parents how to improve the language environment to help their
      children with CIs for their language development. Parents are encouraged to follow these
      advices at home during few months (5 months +/-1 month). Then there is a new registration of
      the LENA device and another language assessment are performed, to see if there is any
      improvement. The investigators also measure the family participation.

      Hypothesis : There is an influence of the language environment measured by the LENA system on
      language development in children with cochlear implants.
    

Detailed description: 
      Over 24 months the investigators will recruit 90 patients with cochlear implants (CIs) in 2
      centers.

      Each patient will follow during 5 months and will have three or five visits according to the
      arm.
    

Intervention name(s): LENA and advice; LENA without advice
Intervention type(s): Behavioral; Other
Intervention description(s): Language recording with the LENA device, with the LENA results, we will advise the parents how to improve the language environment to help their children with CIs for their language development; Language recording with the LENA device. Regular speech therapy follow blindly the results of LENA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: cochlear implant; language environment; speech therapy assessment; LENA technology
GABA-B Receptor Function in Healthy Volunteers
Condition: No Condition; Brain GABA-B Function
Study type: Interventional

Summary: 
      There are several developing lines of evidence suggesting that brain receptors called GABA-B
      receptors play a significant role in addiction and its treatment. The investigators wish to
      examine the sensitivity of brain GABA-B receptors in alcohol and opiate addicts as part of
      the investigators MRC programme of research in neurotransmitters in alcohol and opiate
      addiction (NOAA). In this present study the investigators will give 2 different single doses
      of a drug called baclofen, and a placebo, to 8 healthy male volunteers. This drug affects
      GABA-B receptors in the central nervous system and is licensed for the treatment of
      spasticity in people with eg spinal injuries; the investigators are interested in its effects
      on brain GABA-B receptors. The investigators will measure EEG (brainwaves), eye movements,
      blood pressure and heart rate, motor co-ordination and subjective effects and also blood
      levels of the drug in the investigators volunteers before and at intervals after dosing. The
      investigators will use a double-blind randomised design to minimise expectation effects. The
      study will provide information on timing and magnitude of effects of baclofen on brain
      function in healthy subjects so that the investigators can optimise selection and timing of
      functional measures in future studies of addicts.
    

Detailed description: 
      After informed consent and screening participants will attend for 3 study days. On each of
      these there will be a set of baseline measurements including EEG, saccadic eye movements,
      vital signs, motor co-ordination task, subjective visual analogue ratings and questionnaires
      and blood sample. After dosing these measurements will be repeated at intervals during the
      day up to 6 hours after dosing. Participants will be allowed home after a health check.
    

Intervention name(s): Baclofen 10mg; Baclofen 60mg; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Baclofen 10mg single dose po; Baclofen 60mg single dose po; placebo
Intervention MeSH terms: Baclofen
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: GABA-B
The MOM Program: 5 Year Follow-up Study of a Home Visiting Program at The Children's Hospital of Philadelphia
Condition: Child Development
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the MOM Program Continuation is to promote child development by helping
      families become more competent in accessing and using available health, developmental and
      educational resources. The program focuses are childhood immunizations, Early Intervention
      services, lead screening, Early Head Start and Head Start enrollment. The Intervention
      consists of frequent phone calls and home visits to encourage mothers to have their babies
      immunized on schedule and to participate in needed developmental and educational services.
      The program seeks to fill the gap between children's need for services and mothers' ability
      to assure their children's participation in those services.
    

Detailed description: 
      The MOM Program Continuation builds on the work of The MOM Program, a 3 year randomized
      intervention. The premise of the MOM Program was that professional support through home
      visits and frequent phone contacts would improve children's cognitive and behavioral
      development, ultimately improving their early educational success. The children were enrolled
      in the MOM Program at birth. The MOM Program Continuation provides continued intervention for
      the children and mothers of the original cohort to assure that the children are prepared for
      kindergarten entry at 5 years of age and to evaluate the children's cognitive and behavioral
      outcomes at age 5 years. The program will also create a longitudinal database to study the
      linkages between maternal cognitive ability and child cognitive, educational, and behavioral
      outcomes through entry into school.
    

Intervention name(s): Home visiting professional support model; Control
Intervention type(s): Behavioral; Other
Intervention description(s): Home visits and telephone calls keyed to well child visits.; The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information
Other intervention name(s): No intervention, informational booklet only
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: child, preschool; intelligence; environment; home visiting