bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Trial to Assess Safety, Tolerability and the Pharmacodynamic Effect of Different Concentrations of a New Anti-inflammatory Substance in Subjects With Chronic Plaque Psoriasis
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess safety and tolerability after treatment with LEO 134310 cutaneous solution.
    


Intervention name(s): LEO 134310; LEO 134310; LEO 134310; LEO 134310; LEO 134310 vehicle; 0.1% betamethasone valerate ointment (class III steroid)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Active substance: LEO 134310 is a compound in development at LEO Pharma A/S; Active substance: LEO 134310 is a compound in development at LEO Pharma A/S; Active substance: LEO 134310 is a compound in development at LEO Pharma A/S; Active substance: LEO 134310 is a compound in development at LEO Pharma A/S; Active substance: none; Active substance: betamethasone valerate
Intervention MeSH terms: Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Betamethasone sodium phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intra-individual comparison of all treatment
Masking: Single (Investigator)
Primary purpose: Treatment
Comparisons of iv Ibuprofen and iv Paracetamol During Bariatric Surgery
Condition: Bariatric Surgery Candidate; Obesity, Morbid
MeSH terms: Obesity, Morbid
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to evaluate and to compare the effectiveness of iv ibuprofen and iv
      paracetamol during bariatric surgery.
    

Detailed description: 
      Evaluation of effectiveness of iv ibuprofen and iv paracetamol on postoperative pain, opioid
      consumption, and side effects in morbidly obese patients undergoing bariatric laparoscopic
      surgery
    

Intervention name(s): paracetamol; ibuprofen
Intervention type(s): Drug; Drug
Intervention description(s): iv paracetamol flakon, 1 gram infusion at 30 min;
iv morphine with patient controlled analgesia (1 mg demand bolus dose, 20 min lockout time); iv ibuprofen flakon, 800 mg;
iv morphine with patient controlled analgesia (1 mg demand bolus dose, 20 min lockout time)
Other intervention name(s): Acetaminophen; İntrafen
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: bariatric surgery; morbid obesity; nonopioid analgesics
Continuous Sample Collection Study
Condition: Pregnancy
Study type: Observational

Summary: 
      This study will provide urine cycles from both pregnant and not pregnant volunteers to
      maintain the SPD sample bank.

      Study volunteers, seeking to conceive will be provided with Clearblue Ovulation product to
      help them pinpoint their most fertile time and aid conception. All volunteers will provide
      daily early morning urine samples throughout the study period and keep a study diary of
      menses and pregnancy test results for 1 menstrual cycle.

      Urine samples will be received in the clinical laboratory and aliquoted into 2.25ml amounts
      at stored at -80˚C until required.

      The study will also gather optional information from volunteers regarding a woman's general
      health and stress levels when trying to conceive. This will be used to study the relationship
      between general health, stress and conception.
    

Detailed description: 
      This study will provide urine cycles from both pregnant and not pregnant volunteers to
      maintain the SPD sample bank.

      Study volunteers, seeking to conceive will be recruited to the study after providing written
      informed consent. All volunteers will be provided with Clearblue Ovulation product to help
      them pinpoint their most fertile time and aid conception and be required to collect daily
      early morning urine samples throughout the study until pregnancy is conformed or their next
      menstrual period starts. Volunteers will be required to keep a daily diary of menses, sample
      collection and pregnancy test results. The study will last for 1 menstrual cycle.

      Urine samples will be received in the clinical laboratory will be tested for the presence of
      hormones related to pregnancy and fertility, then aliquoted into 2.25ml amounts at stored in
      the SPD BioBank at -80˚C until required for product development or evaluation .

      The study will also gather optional information from volunteers regarding a woman's general
      health and stress levels when trying to conceive. This will be used to study the relationship
      between general health, stress and conception.

      Demographic data will be summarised. No statistical analysis will be conducted on the data.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers
      
Biospecimen description: 
      Urine samples collected during study
Microsurgical Instruments and Magnification May Enhance Treatment Outcomes Of Laterally Moved, Coronally Advanced Flap in Miller Class III Isolated Recession Defects
Condition: Gingival Recession, Mucogingival Surgery
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      The benefits of microsurgical approaches in periodontal therapy have been described. The main
      focus of this study is to determine if using microsurgical LMCAF technique would improve the
      outcomes of the therapy for the Miller Class III isolated recession-type defects.

      Six months results of this study showed that LMCAF with microsurgical approach offered better
      complete and mean root coverage results over macrosurgical LMCAF technique. The superior
      effect of microsurgical approach on post-operative morbidity can make this technique more
      preferable for the patients who expected comfortable postoperative period.

      This study supports that using the microsurgical aproach with LMCAF procedure significantly
      affects the clinical and patient-centered success of treating Miller Class III isolated typed
      defects.
    


Intervention name(s): laterally moved coronally advanced flap with microsurgical instruments and x2.5 loupe
Intervention type(s): Procedure
Intervention description(s): The recipient area for the laterally moved flap was prepared. When the flap was moved in the distal-mesial direction another short horizontal incision was performed at the most apical extension of this vertical incision. Once the mucogingival line was reached, flap elevation was continued split-thickness. Flap elevation was terminated when it was possible to passively move the flap laterally above the exposed root. Flap was sutured.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer Subjects With the Overexpression of HER2
Condition: Gastric Cancer; HER2 Overexpressing Gastric Carcinoma
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy and safety of intravenous RC48-ADC in local advanced or
      metastatic gastric patients with the overexpression of HER2.
    


Intervention name(s): RC48-ADC
Intervention type(s): Drug
Intervention description(s): 2.5 mg/kg IV every 2 weeks
Other intervention name(s): Recombinant Humanized anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection
Intervention MeSH terms: Trastuzumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: RC48-ADC; HER2 overexpression; Gastric cancer
Simplex High Viscosity Bone Cement in Primary Total Knee Arthroplasty
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      In this study the investigators propose to monitor subjects who have received Triathlon total
      knee components inserted with HV cement. The primary outcome will be fixation of the tibial
      implant component as assessed with RSA and to determine the functionality of patients after
      surgery using self-reported questionnaires. This is a historical control study, comparing the
      study cohort to a previous group with Triathlon implants and the long-standing Simplex T
      cement. The secondary outcomes are inducible displacements of the implants as well as a
      qualitative evaluation of the cement handling characteristics performed by the operating room
      staff.
    


Intervention name(s): Simplex High Viscosity Bone Cement
Intervention type(s): Device
Intervention description(s): high viscosity bone cement for total knee replacement
Other intervention name(s): HV Bone Cement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: total knee arthroplasty
Safety and Efficacy of TACLONEX Ointment in Adolescent Patients (Aged 12 to 17 Years) With Psoriasis Vulgaris
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of 4 weeks of TACLONEX
      ointment in adolescent patients with psoriasis vulgaris.
    

Detailed description: 
      TACLONEX ointment has marketing approval in many countries for the treatment of psoriasis
      vulgaris in adults. No studies have been conducted in patients less than 18 years of age.
      However, about 25% of affected individuals are diagnosed between 10 and 19 years of age,
      hence psoriasis is also prevalent in the adolescent age group (12-17 years).

      All patients will receive TACLONEX. To evaluate the safety of TACLONEX ointment, all adverse
      events will be recorded. In addition, any systemic absorption of the active components,
      betamethasone dipropionate and calcipotriene, will be evaluated by assessing adrenal function
      (using CORTROSYN™ test) and calcium metabolism (by measuring serum calcium and the urinary
      calcium:creatinine ratio), respectively.
    

Intervention name(s): Calcipotriene plus betamethasone dipropionate ointment
Intervention type(s): Drug
Intervention description(s): Once daily application for 4 weeks
Intervention MeSH terms: Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Calcipotriene; Betamethasone sodium phosphate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Sloan-Charts for Assessment of Disease Progress in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      Impairment of visual deficits, in particular contrast acuity and contrast impairment are
      frequent symptoms in MS. However, visual function is not appropriately covered by the
      standard tools for clinical assessment, namely, the EDSS and the MSFC.

      The primary aim of this study is to investigate, whether in MS patients contrast acuity and
      sensitivity change over a period of two years.

      Secondary aims are the correlation of visual contrast parameters with structural retinal
      changes and quality of life.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with Clinically Isolated Syndrome or Definite Multiple Sclerosis
      
Keywords: Multiple Sclerosis; Visual Contrast Acuity; Visual Contrast Sensitivity; Sloan Charts
Caprylic Triglyceride for Treatment of Cognitive Impairments in Multiple Sclerosis
Condition: Relapsing Remitting MS; Secondary Progressive MS; Primary Progressive MS
MeSH terms: Multiple Sclerosis; Sclerosis; Cognitive Dysfunction
Study type: Interventional

Summary: 
      Background/Rationale: Cognitive problems are a common symptom in individuals with Multiple
      Sclerosis (MS). Treatment options are limited, and there is a pressing need for new
      interventions to treat MS-related cognitive impairment. Glucose (a type of sugar) is used to
      fuel the cells of the healthy brain. For people with neurological conditions such as MS,
      glucose is not converted into energy as efficiently as it would be in a healthy brain, which
      can lead to a decrease in cognitive function. Caprylic Triglyceride may work to bypass this
      problem by providing an alternative energy source that is metabolized in the liver and used
      by the brain.

      Objective: To evaluate the therapeutic effects of 90 days of caprylic triglyceride on
      cognitive impairment in multiple sclerosis.

      Design: Randomized, double blinded, placebo controlled trial of 158 subjects.

      Outcome: Change in Total Learning (Trials 1-5) on the California Verbal Learning Test-2nd
      Edition-(CVLT-II) AND Change in Symbol Digit Modalities Test (SDMT) (at day 90
    

Detailed description: 
      Patients with all types of MS (Relapsing Remitting, Secondary Progressive, or Primary
      Progressive) are eligible to participate. Participants will undergo detailed cognitive
      assessment before initiating treatment and again after 90 days of treatment, to determine
      whether Caprylic Triglyceride demonstrates a benefit over placebo.

      Dosage: 40 gram packet orally once a day Duration of Treatment: 90 days

      Analyses: Interim analyses will be conducted after 72 subjects have completed the trial and
      objective STOP criteria for efficacy and futility have been defined in the protocol. Final
      analyses will be an intent-to-treat (ITT) analysis to evaluate each of the primary aims.
    

Intervention name(s): Caprylic Triglyceride; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Caprylic Triglyceride is a medical food that is used for the dietary management of the metabolic processes associated with mild to moderate Alzheimer's disease.; Placebo (40 gram packet orally once a day for 90 days)
Other intervention name(s): Axona
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognition; Neuropsychology; Multiple Sclerosis
Study for Multiple Doses of HM15136 in Obese or Overweight Subjects With Comorbidities
Condition: Obese With Comorbidities; Overweight With Comorbidities; Type2 Diabetes
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      The planned period of each cohort is 22 weeks including subject screening, treatments for 12
      weeks, and follow up period.
    


Intervention name(s): HM15136; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort. In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional.; In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort. In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Study of Omalizumab (CMAB007 and Xolair) in Healthy Subjects to Compare the PK, PD, Safety and Immunogenicity
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase 1, randomized, double-blind, parallel group, single-dose study to compare the
      pharmacokinetics, pharmacodynamics, safety and immunogenicity of two formulations of
      Omalizumab (CMAB007 and Xolair) in healthy subjects.
    

Detailed description: 
      This is a randomized, double-blind, parallel-controlled, single-dose phase I clinical study
      in healthy Chinese male subjects. A total of 114 subjects were planned to be enrolled and
      randomly assigned to the test group or the control group in a 1:1 ratio. Subjects in both
      groups received a single subcutaneous injection of CMAB007 or Xolair#Omalizumab# 150 mg,
      respectively. Subjects in both groups were observed for 106 days after administration to
      evaluate similarities in PK, PD, safety, and immunogenicity.
    

Intervention name(s): CMAB007; Xolair
Intervention type(s): Biological; Biological
Intervention description(s): for subcutaneous injection only; for subcutaneous injection only
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Biological: CMAB007 Biological: Xolair #Omalizumab#
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Chewy Satiety - the Interplay Between Food Structure, Oral Processing and Satiety
Condition: Subjective Appetite and Satiety
Study type: Interventional

Summary: 
      This study examines if there are differences in satiety responses between structurally
      different wholegrain rye products.
    

Detailed description: 
      The study consists of a satiety trial and mastication trial. The satiety trial consists of
      five study visits. Five cereal products with berry soup are presented in random order for
      each subject serving one of them in each study visit (crossover study design). Each meal
      consists of rye product or wheat bread providing 190 kcal of energy and of 3 dl berry soup (3
      dl) providing 140 kcal of energy. The participants are instructed to evaluate their satiety
      and related sensations before eating the test food, right after eating and then every 30 min
      until 210 min after breakfast consumption. The evaluated sensations are hunger, fullness,
      satiety, desire to eat and prospective food consumption ("How much would you be able to eat
      right now?"), "thirstiness", "mood", "vigourosness" and "pleasantness"."Pleasantness" will be
      evaluated only right after eating the test food.

      Cereal food samples with 3-digit number codes will be offered to each participant in a random
      order in mastication trial. The study products are rye products with varying structures.
      First the participant is asked to evaluate the expected satiety of the product (How filling
      would you expect this portion to be on a scale from 0 (=not full at all) to 10 (=extremely
      full)). Secondly the same food will be served to the participant in three portions and the
      participant will be asked to masticate each portion until she considers it to be ready for
      swallowing. Instead of swallowing the bolus will be expectorated to a plastic container which
      is kept on ice. The mastication process is characterized by measuring electrical activity of
      facial muscles by electromyography (EMG). The mastication process will be video-recorded to
      support data handling.
    

Intervention name(s): Rye products with varying structures
Intervention type(s): Other
Intervention description(s): The satiating effect of rye products with various structures will be studied
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Satiety, appetite, wholegrain rye
Clobazam in Patients With Lennox-Gastaut Syndrome
Condition: Epilepsy; Epilepsy, Generalized; Seizures
MeSH terms: Epilepsy; Seizures; Lennox Gastaut Syndrome; Epilepsy, Generalized
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of clobazam as adjunctive
      therapy in the treatment of seizures which lead to drop attacks (drop seizures) in patients 2
      to 60 years of age with Lennox-Gastaut Syndrome (LGS). Patients will be enrolled at
      approximately 65 sites in the U.S. and ex-US for up to 23 weeks. Patients will be randomly
      assigned to either a low, medium or high dose, or placebo. The study will include a baseline
      period, a titration period and a maintenance period. After the maintenance period, patients
      will either continue into an open-label extension study or enter the taper period with a
      final visit 1 week after the last dose.
    

Detailed description: 
      LGS poses a significant treatment challenge. No single antiepileptic drug (AED) provides
      satisfactory relief for all or most patients with LGS and a combination of treatments is
      often required. Even with combination therapy, many LGS patients show resistance to
      treatment. Adjunctive therapy with newer anticonvulsant medications has demonstrated efficacy
      for some patients, although polytherapy and high medication doses are often associated with
      unfavorable adverse event profiles.

      More effective and better-tolerated treatment options are needed for this population of
      medically intractable epilepsy patients. Clobazam may provide an improved safety profile
      compared to other AEDs currently approved for the treatment of LGS and may have less
      hypotonia and drooling effects than other benzodiazepines.
    

Intervention name(s): Clobazam Low Dose; Clobazam Medium Dose; Clobazam High Dose; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 0.25 mg/kg/day; tablets; orally; for 15-18 weeks; 0.5 mg/kg/day; tablets; orally; for 15-18 weeks; 1.0 mg/kg/day; tablets; orally; for 15-18 weeks; tablets; orally; daily for 15-18 weeks
Other intervention name(s): Onfi™; Onfi™; Onfi™
Intervention MeSH terms: Clobazam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Epilepsy; Lennox-Gastaut Syndrome; Drop seizures; Clobazam
Effects of Tongue Tamers as an Early Treatment of Anterior Open Bite
Condition: Tongue Habits; Open Bite
MeSH terms: Open Bite
Study type: Interventional

Summary: 
      Anterior open bite (AOB) is a malocclusion that causes aesthetic, speech, feeding, and
      psychological concerns, emphasizing the significance of beginning treatment as soon as
      possible to correct the disorder. The main etiological determinants of AOB include
      finger-sucking, pacifiers, and oral habits; hence, it is vital to use interceptive treatments
      focused on correcting and increasing bite stability during childhood to avoid the need for
      advanced therapy
    


Intervention name(s): bonded tongue tamers; customized bonded spurs; conventional fixed palatal spurs
Intervention type(s): Device; Device; Device
Intervention description(s): Enamel surface will be treated initially with 37% phosphoric acid for 30 seconds then tongue tamers will be bonded to the palatal/lingual surface of upper and lower central incisors; Composite restoration will be used to fabricate the customized bonded spurs with sharp ends and 3 mm in length.; conventional fixed palatal spurs will be fabricated by taking impression after band selection, then the spurs appliance will be fabricated from 0.9 mm stainless steel wire and soldered to the bands bilaterally.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: open bite; tongue thrust; habit breaking appliance