bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 2 Study to Evaluate the Safety and Efficacy of ABP-450 in the Treatment of Cervical Dystonia
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2 trial will evaluate the safety and efficacy of ABP-450 for the treatment of
      cervical dystonia in adults. The study will enroll 60 patients across approximately 30 sites
      in the United States. Study subjects will be divided evenly across a low dose group, a medium
      dose group, a high dose group, and a placebo group for one treatment cycle.
    

Detailed description: 
      This Phase 2 trial will evaluate the safety and efficacy of ABP-450 for the treatment of
      cervical dystonia in adults. The study will enroll 60 patients across approximately 30 sites
      in the United States. Study subjects will be divided evenly across a low dose, a medium dose
      group, a high dose and placebo group for one treatment cycle.
    

Intervention name(s): ABP-450; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ABP-450 (prabotulinumtoxinA) contains a 900kDA botulinum toxin type-A complex produced by the bacterium Clostridium botulinum.; 0.9% sodium chloride, sterile, unpreserved, USP/Ph.Eur.
Other intervention name(s): prabotulinumtoxinA; 0.9% sodium chloride; saline
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Approximately 60 patients will be randomized in a 1:1:1:1 ratio and receive one of the four treatments: ABP-450 low dose, ABP-450 mid dose, ABP-450 high dose, or placebo via intramuscular injection into affected neck muscles.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Opiorphin Levels in Fluids of Burning Mouth Syndrome Patients (OPIODYN)
Condition: Burning Mouth Syndrome
MeSH terms: Burning Mouth Syndrome; Syndrome; Burns
Study type: Interventional

Summary: 
      If epidemiological studies indicate relatively low prevalence reported in the general
      population, idiopathic burning mouth syndrome (BMS) is a common condition among certain
      groups of the population: 30% of menopausal women experience oral burning to varying degrees
      . Despite significant progress made in recent years, in understanding the physiopathogeny,
      treatment options remain limited and disappointing,resulting in an impairment of the quality
      of life. Given the chronic nature of idiopathic burning mouth syndrome, the need to identify
      the causes and effective treatment modalities for subjects suffering is essential.
    

Detailed description: 
      Idiopathic burning mouth syndrome (BMS) is a chronic orofacial pain condition in which the
      pain is felt as intense, located on the tongue and the oral mucosa with no known cause. The
      pain may last for years and present treatments are of little effect. BMS is primarily a
      feminine disease, affecting women during or following menopause, suggesting an etiopathogenic
      role of the sexual hormones potentiating a local salivary factor. An anxiodepressive
      component is often associated with the disease. Recently, a molecule named opiorphin has been
      identified in human saliva. In animals, this molecule has shown potent analgesic properties
      comparable to those of morphine. The hypothesis of the investigators is that this molecule is
      in lower quantity in the saliva of persons suffering BMS and that this decrease causes oral
      burning sensations.

      The main objective of the study is to test the hypothesis of a decrease of opiorphin levels
      in the saliva of patients suffering from primary BMS compared to a group of control subjects.
      The main judgment criteria is the level of salivary opiorphin in ng/mL.

      The proposed study is a multicentric, simple blinded case controlled study. The investigators
      will collect the data from 21 primary BMS patients and 21 control subjects matched in sex,
      age, and hormonal status (menopause). The alpha risk is 0.5% and the power of the study is
      90%.

      Criteria for inclusion : BMS patients will be suffering for more than 4 months from burning
      pain in the tongue or oral mucosa with no organic trouble detectable by anamnesis, clinical
      evaluation and biological testing.

      The design of the study includes three sessions for all subject of both groups; the maximum
      duration of participation for a subject is 8 weeks and the total duration of the study is 24
      months There are two investigation centers.
    

Intervention name(s): sample
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Diagnostic
Keywords: physiology; pain; analgesia; saliva; opiorphin
Novel Compositions for Treating or Preventing Dermal Disorders
Condition: Dermal Atrophy
MeSH terms: Atrophy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This trial examines the impact of a topical formulation of rapamycin on dermal thickness and
      senescence.
    

Detailed description: 
      Aging of the skin is the most prominent feature of the aging process, being caused by
      multiple factors such as intrinsic aging process and UV light exposure.

      Dermal atrophy, also called skin atrophy or atrophy, is a disorder manifesting thinning or
      depression of skin due to reduction of underlying tissue. Dermal atrophy is a major clinical
      problem in the elderly population. Loss of dermal integrity leads to increased fragility of
      the skin and precludes the use of intravenous lines in many cases. Skin tears are a
      significant concern in elderly individuals directly related to dermal atrophy. Impairment in
      wound healing is an important clinical sequelae of reduced dermal integrity leading to an
      increase in the number of the infections and complications following injury. Seborrheic
      keratosis, which comprise focal areas of epidermal thickening, can occur, possibly
      representing a response to damage. It has been estimated that 100% of individuals over 50
      years of age harbor at least one of these lesion. There is not treatment for dermal atrophy
      and seborrheic keritoses require excision if they become large enough to cause discomfort or
      distress.

      Therefore, there is a need to develop novel compositions and methods for treating or
      preventing certain age-related dermal conditions.

      Rapamycin is an FDA approved drug that has been in clinical use for over 15 years. Systemic
      application of rapamycin has been a central part of immuno suppressive therapy for transplant
      patients in combination with other immuno suppressants. The safety record for systemic use of
      rapamycin is excellent and few side effects are associated with extended use.
    

Intervention name(s): Rapamycin
Intervention type(s): Drug
Intervention description(s): topical formulation
Other intervention name(s): sirolimus
Intervention MeSH terms: Sirolimus
Intervention model: Single Group Assignment
Intervention model description: Patients will apply lotions containing either rapamycin or vehicle to 2 distinct areas of sun exposed skin.
Masking: None (Open Label)
Primary purpose: Treatment
Validation of Ultrasound as a Diagnostic Tool for Assessment of Hemophilic Arthropathy of Knees and Ankles
Condition: Hemophilia; Hemophilic Arthropathy
MeSH terms: Joint Diseases; Hemophilia A
Study type: Observational

Summary: 
      The purpose of this study is to test the external validity of the systemic ultrasound
      protocol for data acquisition and interpretation, in order to diagnose soft tissue and
      osteochondral abnormalities in hemophilic children.
    

Detailed description: 
      Ultrasound has advantages over MRI as it is less expensive, does not require sedation and is
      more readily available in centres around the world. Given these characteristics of ultrasound
      it is an ideal imaging tool for early assessment of hemophilic joints in countries whose
      access to MRI is limited. Early evaluation of soft tissue changes in young hemophilic
      patients may lead to earlier interventions and better mid-term and long-term clinical
      outcomes. By this way the joint function of hemophilic patients can be preserved, saving
      their joints from severe arthropathy and offering them the possibility of a normal
      professional life in the society.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children attending the Hemophilia clinics at the participating institutions (Universidade
        de São Paulo, Universidade Federal de São Paulo and Universidade Estadual de Campinas), who
        have a history of ankle or knee bleed(s), will be recruited to take part in this study.
      
Keywords: pediatrics; haemophilia; ultrasound; MRI; arthropathy
Post Laparoscopy Shoulder Pain and Postoperative Trendelenburg Position
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional

Summary: 
      Laparoscopic surgery has become a standard of care for many gynecological surgeries due to
      its lower morbidity, pain and cost compared to open techniques. Unfortunately, the use of
      carbon dioxide (CO2) to insufflate the abdomen is a major contributor to post operative
      shoulder pain. Shoulder pain post laparoscopy is common and it is a major cause of patient
      dissatisfaction. The aim of our study is to evaluate the efficacy of positioning the patient
      in Trendelenburg, post operatively for 24 hours, on shoulder pain reduction. Our hypothesis
      is based on the assumption that complete CO2 deflation is not possible and that Trendelenburg
      positioning will help displace CO2 from the sub diaphragmatic area thus reducing the
      diaphragmatic and phrenic nerve irritation causing pain.
    

Detailed description: 
      A prospective randomized controlled study with 54 patients in each of the two arms. Group S
      (control) will undergo the standard laparoscopic procedure and the patients will be placed in
      supine head up position postoperatively. In group T (interventional); the patients will be
      positioned in Trendelenburg position once fully awake and cooperative in the post-anesthesia
      case unit (PACU) and will remain in this position for the first 24 hours postoperatively.
      Postoperative NRS(numeric rating scale) score for shoulder pain and nausea will be collected
      at arrival to PACU, & 4, 6, 12 and 24 hours postoperatively. In addition, total amount of
      rescue pain and nausea medication used by the patient will be recorded. Data collected will
      be analyzed and compared between the two groups. The independent t- test will be used to
      compare postoperative shoulder pain, with NRS scores treated as continuous variable, between
      the two groups.
    

Intervention name(s): 20 degree Trendelenburg position
Intervention type(s): Procedure
Intervention description(s): The patients in the intervention group will be placed in trendelenburg position postoperatively.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: laparoscopy; shoulder pain; trendelenburg position
99mTc-rhAnnexin V-128: a First In Man Study in Healthy Volunteers
Condition: Healthy Adult Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study are:

        -  To determine the safety and tolerability of a single dose of 99mTc-rhAnnexin V-128
           administered as an intravenous bolus over 10-20 seconds.

        -  To determine the biodistribution, pharmacokinetics and radiation dosimetry of
           99mTc-rhAnnexin V-128 in normal healthy adult volunteers.
    


Intervention name(s): Kit for the Preparation of 99mTc-rhAnnexin V-128
Intervention type(s): Drug
Intervention description(s): Kit for the Preparation of Tc-99m Recombinant Human Annexin V-128 for Injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Effects of Casein Timing on Body Composition and Performance
Condition: Body Composition
Study type: Interventional

Summary: 
      This study will investigate the effects of night time versus day time casein supplementation
      on body composition and athletic performance. Participants will consume the protein
      supplements daily while participating in a supervised, periodized resistance training
      program.
    

Detailed description: 
      In a randomized, double-blind, placebo-, exercise- and diet-controlled design, 60 subjects
      will participate in a 10-week study to determine the influence of selective protein timing on
      body composition, metabolic, and performance adaptations to resistance training. Diets will
      be individually standardized using the Cunningham equation adjusted for activity level to
      determine total maintenance calories. Carbohydrates, fats, and proteins will represent 50,
      25, and 25 percent of the determined total calories. Diet counseling will occur weekly until
      stabilized and biweekly thereafter to ensure compliance with food and fluid intake. Protein
      will be distributed throughout the day as >0.30g/kg bw/meal for breakfast, lunch, and dinner.
      Resistance training sessions will be supervised by research staff and occur 4 times per week
      and begin between 7 am and 5pm. Exercises will consist of single- and multi-joint exercises
      for all major muscle groups (legs, chest, back, shoulders, core, and arms), be performed for
      3-5 sets of 1-20 repetitions with 1-5 minutes rest between sets, and each muscle group will
      undergo 72-96 hours rest between training sessions within the periodized program. Protein
      supplements. In the treatment group, the casein supplement (40g calcium caseinate dissolved
      in water) will be consumed as the last meal (>2h following previous meal) before bed and the
      placebo (40g maltodextrin dissolved in water) either before resistance training, if training
      after 10am, or after resistance training, if before 10am. The control group will alternate
      consumption times of the casein supplement and placebo. The supplement (treatment group) or
      placebo (control group) will not be consumed within 3 hours of beginning or ending resistance
      training, nor will it be consumed within 3 hours of the first meal following waking. All
      groups will be provided with 0.30g/kg bw whey protein isolate immediately following training
      to facilitate recovery. Supplements will be consumed at a similar time of day on non-training
      days.
    

Intervention name(s): Protein
Intervention type(s): Dietary Supplement
Intervention description(s): 40g calcium caseinate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Can Neck Circumference Measurements Less Than 43cm or Greater Than 43cm Predict Difficulty of Tracheal Intubation?
Condition: Neck Circumference, Difficulty of Tracheal Intubation
Study type: Observational

Summary: 
      The circumference of a person's neck is a useful predictor of difficulty of insertion of a
      breathing tube.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        adult patients who require tracheal intubation for general anesthesia and surgery
Repetitive Transcranial Magnetic Stimulation and the Development of Ongoing Muscle Pain
Condition: Pain Relief
MeSH terms: Myalgia
Study type: Interventional

Summary: 
      The main purpose of the study is to assess the mechanisms of repeated sessions of repetitive
      trancranial magnetic stimulation (rTMS) applied on left dorsolateral prefrontal cortex on the
      development of pain in a prolonged muscle pain model.
    

Detailed description: 
      This study aims to investigate whether i) rTMS of left DLPFC will reduce the severity and
      duration of experimentally induced muscle pain when a 5-day course of treatment is given
      immediately following an initial nerve growth factor (NGF) injection; ii) the analgesic
      effects of left DLPFC rTMS will be related to an improved cognitive network function as
      assessed by electroencephalography (EEG).
    

Intervention name(s): Repetitive trancranial magnetic stimulation (rTMS) group; Sham group
Intervention type(s): Device; Device
Intervention description(s): Repetitive trancranial magnetic stimulation is applied on the dorsolateral prefrontal cortex. The protocol consists on 20 minutes of 10Hz stimulation, 5 seconds on, 10 seconds off, at 110% RMT, for a total of 4000 pulses.; A sham coil is used to mimic the clicking sound of the trancranial magnetic coil and skin stimulation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: nerve growth factor; repetitive transcranial magnetic stimulation; dorsolateral prefrontal cortex
Trial of Transcranial Direct Current Stimulation (tDCS) Using Alternative Electrode Montages
Condition: Major Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 2

Summary: 
      Among antidepressant treatments, ECT stands as the most effective in treating acute
      depression. However, patient concerns with the cognitive side effects of ECT have encouraged
      the development of new and more focal forms of brain stimulation such as transcranial Direct
      Current Stimulation (tDCS). Our current study of tDCS as a treatment for depression suggests
      that this technique has antidepressant effects and is safe, painless and well tolerated.
      However, not all patients may respond to this treatment in the way that it is currently
      administered and the concern of possible relapse in some patients who respond to tDCS has
      raised interest in finding alternative, possibly more optimal ways of administering tDCS.
      This study will investigate whether using alternative electrode montages can improve the
      antidepressant effects of tDCS in people suffering from depression.
    


Intervention name(s): tDCS (Eldith DC-Stimulator (CE certified))
Intervention type(s): Device
Intervention description(s): tDCS session lasting continuously for 20 minutes at 2 mA. Conductive rubber electrodes (7 x 5 cm = 35 cm2 & 10 x 10 cm = 100 cm2) covered by sponges soaked in saline will be used, held in place by a band. The current will be gradually increased to the level of 2 mA over 30 seconds (to avoid the sensation of a flash).
Other intervention name(s): Eldith DC-Stimulator (CE certified)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: depression; direct current stimulation; extracephalic electrode
The Evaluation of Vitiligous Lesions Repigmentation After Topical Administration of Methotrexate in Patients With Active Vitiligo
Condition: Non-segmental Vitiligo
MeSH terms: Vitiligo
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to evaluate the influence of two concentrations of methotrexate on
      vitiligous lesions in patients with non-segmental vitiligo
    

Detailed description: 
      Methotrexate, synthesized in the 1950s as an anticancer drug with an antiproliferative
      effect, is currently one of the most commonly used immunosuppressive agents in dermatology.
      The use of small, non-oncological doses has revealed its anti-inflammatory properties,
      including the impact on a number of cytokines involved in the pathogenesis of autoimmune
      diseases. It has been shown that treatment with methotrexate reduces the levels of
      TNF-alpha-producing T cells, while the number of IL-10 producing T cells increases.
      Methotrexate also inhibits the synthesis of interferon-γ. The above considerations justify
      the use of topical methotrexate in patients with vitiligo in order to obtain repigmentation.

      A study has been designed as a single-center, randomized, double-blind, placebo-controlled
      pilot study with the enrollment of up to 100 active non-segmental vitiligo patients
      presenting with vitiligous lesions on both upper and lower limbs. Clinical effects of gel
      containing 1% methotrexate or 0.5% methotrexate applied on a preselected limb will be
      assessed in comparison with vehicle ointment applied on the opposite limb. All study
      participants will undergo clinical evaluation using Body Surface Area (BSA) and Vitiligo Area
      Scoring Index (VASI) scales at baseline, week 4, week 8 and week 12 time points. Precise
      assessment of skin lesions will be performed using photographic documentation obtained during
      each study visit and processed with NIS-Elements software.
    

Intervention name(s): 1% Methotrexate gel; 0.5% Methotrexate gel
Intervention type(s): Drug; Drug
Intervention description(s): 1% methotrexate gel applied onto a predefined limb; 0.5% methotrexate gel applied onto a predefined limb
Other intervention name(s): methotrexate; methotrexate
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
An Investigation on the Effects of Icosapent Ethyl (VascepaTM) on Inflammatory Biomarkers in Individuals With COVID-19
Condition: COVID-19; Inflammatory Response
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 14-day long prospective, multi-site, two-armed, randomized, open-label study that
      will enroll approximately 100 adult outpatients in Canada who have received a positive
      SARS-CoV-2 test result within the preceding 72 hours. Participants will be randomized (1:1)
      to receive either icosapent ethyl (4 g BID for 3 days, then 2 g BID for the subsequent 11
      days) or usual care. Blood samples will be collected to determine if icosapent ethyl use
      lowers circulating pro-inflammatory biomarkers.
    


Intervention name(s): Icosapent ethyl
Intervention type(s): Drug
Intervention description(s): Icosapent ethyl (4 g BID for 3 days, then 2 g BID for the subsequent 11 days)
Other intervention name(s): Vascepa
Intervention MeSH terms: Eicosapentaenoic acid ethyl ester
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetic Interactions Between Amlodipine Besylate/Valsartan and Atorvastatin in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the pharmacokinetic interactions between amlodipine
      besylate/valsartan and atorvastatin single or co-administered in healthy volunteers.
    


Intervention name(s): combination administration
Intervention type(s): Drug
Intervention description(s): combination administration : amlodipine/valsartan 10/160mg and atorvastatin 40mg, qd, 10days(oral)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science