bioihbjkbjnl/mcl2 huggingface dataset:
Canadian Treat and Extend Analysis Trial With Ranibizumab
Condition: wetAMD
Study type: Observational

Summary: 
      This is an observational study to will evaluate and compare two Ranibizumab treatment
      regimens (Standard of care) in patients with neovascular (wet) age-related macular
      degeneration (wAMD) aiming to achieve and to maintain a maximum visual function benefit. The
      results will be used to generate further recommendations on the timing of treatment
      administration for patients with neovascular (wet) age-related macular degeneration (wAMD).
      In this context, the study will use the anatomical imaging (for example, optical coherence
      tomography [OCT]) to evaluate wAMD disease activity impacted by the recurrence of disease
      instability and for decision making in the treatment decision algorithm.
    


Intervention name(s): 0.5 mg Ranibizumab intravitreal injections
Intervention type(s): Other
Intervention description(s): All eligible patients will initially be treated in a fixed loading phase, consisting of one intravitreal injection of Ranibizumab 0.5 mg per month for 3 consecutive months (Day 1, Month 1, and Month 2). After the loading phase, patients will be treated according to the treatment arm to which they have been assigned, either a continued once monthly dosing regimen, or an extended schedule of Ranibizumab intravitreal injections as described below. The planned duration of total treatment is 24 months.
Intervention MeSH terms: Ranibizumab
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population will consist of male and female Canadian patients diagnosed with
        visual impairment due to wAMD and for whom Ranibizumab has been prescribed as their
        standard of care by the treating physician. Eligibility for Ranibizumab will be determined
        by the study physician according to the current prescribing information. A total of 580
        patients will be enrolled from approximately 20 to 25 centers.
      
Keywords: Lucentis; Ranibizumab; Treat and Extend; wetAMD; Age related macular degeneration
Non Surgical Periodontal Treatment Effect on Il-17 and Il-18 in Aggressive Periodontitis
Condition: Aggressive Periodontitis
MeSH terms: Periodontitis; Aggressive Periodontitis; Aggression
Study type: Observational

Summary: 
      clinical parameters and IL-17 and Il-18 GCF levels were measured in 25 aggressive
      periodontitis patients compared to 25 periodontally healthy individuals.

      It was observed that that Clinical parameters and Il-17 and Il-18 levels are higher before
      treatment but decreased after treatment which suggests role of these interleukins in
      pathogenesis of aggressive periodontitis .
    

Detailed description: 
      Aggressive periodontitis is a type of rapidly progressing periodontal diseases .The three
      classic primary characteristics of this disease are ; occurring in young healthy patients
      with rapid attachment loss and familial aggregation .Bacteria-host interactions,
      insufficiencies in host defenses and possibly a genetic predisposition represent the
      etiologic factors . Beside the young age of onset, important factors as involvement of host
      factors and non-plaque-related etiologic factors have also been proposed .

      Aim of the study:

      Objectives were to compare and correlate the clinical parameters and biochemical parameters
      (Il-17 and Il-18 levels in GCF) of aggressive periodontitis patients (At baseline and after
      three months of nonsurgical treatment) versus periodontally healthy subjects at baseline.

      Subjects and methods:

      Populations included in the study:

      A total of fifty individuals were enrolled and categorized as; group A that included twenty
      five aggressive periodontitis patients and group B which included twenty five periodontally
      healthy controls.

      Clinical parameters:

      Plaque index (PI) ,gingival index (GI), Probing pocket depth (PPD) and clinical attachment
      level (CAL) were measured at baseline for both groups and after three months of non surgical
      periodontal treatment completion for group A.

      GCF sampling:

      In group A ,the site with deepest probing depth was selected for GCF sampling while for group
      B , any site was sampled using PerioPaper strips .

      Phase I periodontal treatment After baseline GCF sample collection and clinical measurement
      recordings, group A patients received phase I periodontal treatment.

      Analysis of Il-17 and Il-18 levels in GCF:

      GCF samples were examined by enzyme-linked immunosorbent assay (ELISA).Procedures were
      performed according to the directions in the kits.
    

Intervention name(s): non surgical periodontal therapy
Intervention type(s): Procedure
Intervention description(s): Scaling and root planing
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Both genders Age between 18 and 30 years old
      
Biospecimen description: 
      Periopaper strips stored in Eppendorf tubes
    
Keywords: gingival crevicular fluid
Comparison of Dry Needling and Deep Friction Massage in Patients With Subacromial Pain Syndrome
Condition: Subacromial Impingement Syndrome; Trigger Point Pain, Myofascial
MeSH terms: Shoulder Impingement Syndrome; Myofascial Pain Syndromes; Syndrome
Study type: Interventional

Summary: 
      This study was planned to investigate the effects of Trigger Point-Dry Needling Therapy
      (TP-DNT) on night pain and Shoulder Internal Rotation (SIR) in individuals with Subacromial
      Pain Syndrome (SPS).
    

Detailed description: 
      Shoulder pain seen intensely in the general population, many methods has been used for the
      treatment which has not been fully proven to be superior to each other. Before considering
      surgical approaches, trying conservative approaches is emphasized. While literature showed us
      that nighttime pain is an important musculoskeletal symptom, may be associated with local
      inflammation, it is an important feature during the treatment planning. TP-DNT had positive
      effects on night pain and SIR in SPS. It was seen that the treatment satisfaction level of
      participants was high. Despite these positive findings, there is need for further studies in
      which sample size is increased, control group is added, and long-term follow-up is planned.
    

Intervention name(s): Trigger Point Dry Needling Technique; Deep Friction Massage Technique
Intervention type(s): Device; Other
Intervention description(s): The type of needle and the depth of the entrance varied depending on the estimated muscle thickness (0.25 - 25 mm, 0.25 - 30 mm and 0.25-40 mm). The disposable stainless-steel sterile needles were inserted through the skin over the trigger point in the taut band of muscle using the fast-in/out technique. Forward and backward needling was repeated until the local twitch responses were obtained. The depth of the needle was changed depending on the muscle thickness. After the first local twitch response, the needle was moved up and down 3 to 5 mm in only vertical directions until no more local twitch responses were elicited. After removing the needle, the insertion area was compressed with a piece of cotton; For supporting the normal healing conditions, the deep and transverse friction causes hyperaemia in the involved soft tissue, which results in increased blood ﬂow to the area.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dry needling, subacromial joint, night pain
To Evaluate the Efficacy and Safety of DW1903 in Acute and Chronic Gastritis Patient
Condition: Gastritis Acute; Gastritis Chronic
MeSH terms: Gastritis
Study type: Interventional
Phase: Phase 3

Summary: 
      A Multi-center, Double-blind, Randomized, Parallel, Active-controlled, Non-inferiority, Phase
      III Clinical Trial to Evaluate the Efficacy and Safety of DW1903 in Patients with Gastritis
    


Intervention name(s): DW1903; DW1903-R1
Intervention type(s): Drug; Drug
Intervention description(s): q.d. PO, DW1903 + Placebo of DW1903-R1; q.d. PO, Placebo of DW1903 + DW1903-R1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Immunogenicity of a Booster Dose of -H5N1 Influenza Vaccine
Condition: Avian Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess persistence of antibody titers 17-18 months after primary immunization with two
      0.5mL intramuscular (IM) doses of H5N1 influenza vaccine containing H5N1 influenza antigen,
      as measured by Hemagglutination Inhibition (HI), Single Radial Hemolysis (SRH), and
      Microneutralization (MN) test
    


Intervention name(s): H5N1 influenza vaccine; H5N1 influenza vaccine
Intervention type(s): Biological; Biological
Intervention description(s): One 0.5 ml booster injection 12 months after the second injection, of influenza vaccine containing 7.5 micrograms of H5N1 influenza antigen; One 0.5 ml booster injection 12 months after the second injection, of influenza vaccine containing 15.0 micrograms of H5N1 influenza antigen
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: H5N1 Pandemic
A Pilot Study of the Effects of Botulinum Toxin in the Treatment of Provoked Vestibulodynia
Condition: Vestibulodynia
MeSH terms: Vulvodynia; Vulvar Vestibulitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objective of this study is to compare the efficacy of botulinum toxin injections on
      vestibulodynia pain compared to a group treated with a placebo.
    


Intervention name(s): Botulinum Toxin Type A; Saline solution; Indexes
Intervention type(s): Drug; Other; Other
Intervention description(s): Visual Analogic Scale (VAS), Female Sexual Function Index (FSFI), Dermatology Life Quality Index (DLQI)
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Botulinum toxin; Pain improvement
Effect of Agaricus Blazei (Murrill) ss. Heinemann (Sun Mushroom)
Condition: Hepatitis C; Nutritional Status; Hepatitis, Viral, Human
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis, Viral, Human; Hepatitis
Study type: Interventional

Summary: 
      The aim of the study was to verify the influence of Agaricus blazei (Murrill) ss. Heinemann
      (A. blazei) on the evolution of nutritional state and liver function in hepatitis C patients.
    

Detailed description: 
      Ten patients were studied (5 - GI - not taking A. blazei - and 5 - G2 - taking A. blazei),
      from both sexes, with positive Anti-VHC and a healthy nutritional state, admitted into in the
      viral hepatitis ward. Diagnosis and treatment for hepatitis C concurred with the regulations
      of the Ministry of Health and nutritional evaluation was performed in 3 moments according to
      anthropometrical, bioimpedance, biochemical and dietary standards, with duration of 6 months.
      The consumption of A. blazei (10g/day) in dehydrated powder was concomitant with antiviral
      therapy (conventional or pegylated interferon associated with ribavirin) with duration of 5
      months.
    

Intervention name(s): Agaricus blazei (Murrill) ss. Heinemann (sun mushroom)
Intervention type(s): Dietary Supplement
Intervention description(s): Agaricus blazei powder, 10 grams/day, for 5 months
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Agaricus blazei (Murrill) ss. Heinemann,; Hepatitis C; Nutritional status; Liver Function Tests; Antiviral Agents
A Trial to Learn How Much Rivaroxaban Gets Into the Blood When Taken in Different Forms and How Safe They Are in Healthy Men
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Researchers are looking for a better way to treat venous thromboembolic disease, also known
      as VTE. In people with VTE, blood clots form in the veins of the legs, groin, or arms. These
      clots or a piece of a clot can break free and move around the body in the blood vessels.
      These clots can block small blood vessels, causing other conditions like high blood pressure,
      heart attack, and stroke.

      Before people with a medical condition can take an approved treatment in a new form,
      researchers do trials in healthy participants. This helps them understand how the new form
      acts in the body and to better understand its safety.

      In this trial, the researchers will compare how much of the trial treatment gets into the
      blood when taken in 2 different forms in a small number of participants. The trial will
      include about 30 men who are aged 18 to 55.

      In this trial, there will be 2 groups of participants. The participants will take rivaroxaban
      in the current tablet form and in a new liquid form 1 time. This was a "crossover" trial. In
      a crossover trial, all the participants will take both forms of the treatments, but in a
      different order.

      During the trial, the participants will stay at their trial site 2 times for 5 days. But, the
      participants can be in the trial for up to about 6 weeks. During the trial, the doctors will
      take blood and urine samples and check the participants' heart health using an
      electrocardiogram (ECG) and measure the blood pressure. The participants will also answer
      questions about how they are feeling, if they have any medical problems, and about any
      medications they are taking.
    


Intervention name(s): 20 mg tablet rivaroxaban; 20 mg rivaroxaban, granules for oral suspension
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose of a 20 mg tablet rivaroxaban, administered under fed conditions; Single oral dose of 20 mg rivaroxaban, granules for oral suspension administered under fed conditions.
Intervention MeSH terms: Rivaroxaban
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Determine the Absolute Bioavailability of BIIB122/DNL151 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, non-randomized, open label Phase 1 study to determine the PK and
      absolute bioavailability of BIIB122 (DNL151) in 2 conditions: following a single, oral dose
      of BIIB122 (DNL151) and following consecutive days of oral dosing, approximating steady
      state.
    

Detailed description: 
      This clinical trial information was submitted voluntarily under the applicable law and,
      therefore, certain submission deadlines may not apply. (That is, clinical trial information
      for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public
      Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by
      sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
    

Intervention name(s): BIIB122 (DNL151); [14C] BIIB122 ([14C] DNL151)
Intervention type(s): Drug; Drug
Intervention description(s): Oral doses; Intravenous doses
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
ZAGAL Study: Evaluating Effectiveness and Tolerability of Zonisamide as Adjunctive Therapy in Patients With Partial Onset Seizures Treated With Two Antiepileptic Drugs
Condition: Epilepsy
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to acquire additional information about the appropriate level of
      dosing of Zonisamide when it is prescribed for patients with partial onset epileptic crisis
      who are already being treated with two other antiepileptic drugs.
    

Detailed description: 
      Patients from both sexes, 18 to 65 years of age, diagnosed with simple or complex partial
      onset epileptic crisis defined according to the International League Against Epilepsy (ILAE)
      criteria, with a minimum of two seizures within the 4 previous weeks, a stable treatment with
      two antiepileptic drugs for at least 12 weeks, and capable and willing to give their informed
      consent, will be included in the study.

      To these patients, physicians will prescribe zonisamide in the following manner: Titration
      period of 12 weeks, at the end of which all patients must be taking 300 mg. Maintenance doses
      period of 12 weeks, at the beginning of which, physicians will decide to keep the 300 mg dose
      from the titration period, lower it to 200 mg, or take it up to 400 mg. Six weeks later
      within this period, a decision will be made to raise the 400 mg doses up to 500 mg if
      considered necessary and tolerable.

      Drugs will be prescribed by the physician and purchased by the patient.
    

Intervention name(s): Zonisamide
Intervention type(s): Drug
Intervention description(s): 300 mg tablet. Maintenance dosing period of 12 weeks, at the beginning of which, physicians will decide to keep the 300 mg dose from the titration period, lower it to 200 mg, or take it up to 400 mg.
Other intervention name(s): Zonegran
Intervention MeSH terms: Zonisamide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: zonisamide; partial onset seizures; effectiveness; tolerability
A Pilot Trial of Acute N-Acetylcysteine Effects on Working Memory and Other Cognitive Functions in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of the amino acid supplement
      N-Acetylcysteine versus placebo on working memory and other cognitive functions in persons
      with a diagnosis of schizophrenia.
    

Detailed description: 
      Working memory impairment in Schizophrenia is produced by deficiencies of feedback inhibition
      of glutamate release, due to low cysteine-glutamate antiporter activity. Because of this
      mechanism, we are interested in whether acute administration of N-Acetylcysteine will improve
      performance of patients with schizophrenia on a battery of cognitive tasks utilized to test
      working memory and other cognitive domains, versus placebo. This pilot study will utilize a
      randomized, double blind, placebo controlled, crossover design.
    

Intervention name(s): N-Acetylcysteine; Placebo
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): N-acetylcysteine 1200mg bid for 3 days; Placebo
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia; working memory; N-Acetylcysteine
Validation of the Utility of an Artificial System for the Large-scale Screening of Scoliosis
Condition: Orthopedic Disorder of Spine; Artificial Intelligence; Scoliosis
MeSH terms: Scoliosis; Musculoskeletal Diseases; Spinal Diseases
Study type: Interventional

Summary: 
      Traditional school scoliosis screening approaches remains debatable due to unnecessary
      referal and excessive cost. Deep learning algorithms have proven to be powerful tools for the
      detection of multiple diseases; however, the application of such methods in scoliosis
      screening requires further assessment and validation. Here, the investigators develop an
      artificial system for the automated screening of scoliosis using disrobed back images, and
      conduct clinical trial to validate if the diagnostic system can offsetting the shortcomings
      of human doctors.
    


Intervention name(s): An artificial system for the screening of scoliosis
Intervention type(s): Device
Intervention description(s): An artificial intelligence to make evaluation of scoliosis using back images
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Orthopedic Disorder of Spine
A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Liver Transplantation
Condition: Liver Transplantation
Study type: Interventional
Phase: Phase 3

Summary: 
      The patients about to undergo liver transplantation will be randomized to one of the
      following two group:

      Group FK506MR: FK506MR/steroid; Group Prograf® : Prograf® /steroid The treatment period is 3
      months(12 weeks
    


Intervention name(s): Tacrolimus modified-release; Prograf
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): Advagraf; FK506MR; MR4; tacrolimus; FK506
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Liver Transplantation; Tacrolimus; Methylprednisolone; Prednisolone
Evaluation of SPN-812 (Viloxazine Extended-release Capsule) Low Dose in Children With ADHD
Condition: ADHD
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy and safety of low doses of SPN-812 in children 6-11
      years of age diagnosed with ADHD.
    

Detailed description: 
      This is a multicenter, randomized, double-blind, placebo-controlled, 3-arm, parallel-group
      study, to assess the efficacy and safety of SPN-812 as monotherapy for the treatment of
      children 6-11 years old with ADHD.
    

Intervention name(s): Placebo; 100mg SPN-812; 200mg SPN-812
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo was administered once daily; 100mg SPN-812 was administered once daily and compared to placebo; 200mg SPN-812 was administered once daily and compared to placebo
Other intervention name(s): PBO; SPN-812; SPN-812
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment