bioihbjkbjnl/mcl2 huggingface dataset:
Polidocanol Versus Glucose Treatment of Telangiectasia Trial
Condition: Varicose Veins; Telangiectasis
MeSH terms: Telangiectasis; Varicose Veins
Study type: Interventional
Phase: Phase 4

Summary: 
      It will be done a randomized triple-blind study comparing 0,2% polidocanol versus 75%
      hypertonic glucose of sclerotherapy in lower limbs´ telangiectasis. It will be included only
      adult women with reticular veins on the side of the thighs and mild venous insufficiency
      (CEAP 1). The primary endpoint will be efficacy, and secondary will be safety.
    

Detailed description: 
      Background. The prevalence of chronic venous disease is high in the general population,
      mainly in young women, and in milder cases the usual complaint is aesthetic. Various
      techniques are used for treatment of mild varicose disease, including surgical treatment,
      laser ablation and sclerotherapy. Telangiectasis are those with less than 1 mm diameter,
      reddish and important contribution to the aesthetic damage, and sometimes they are related to
      local pain. There is no consensus in the literature about the effectiveness of treatment with
      sclerotherapy, despite of being an usual procedure with different chemicals.

      Methods and design. One hundred lower limbs of healthy women between 18 and 65 years will be
      triple blind randomized to receive treatment with polidocanol 0.2% diluted in 70% hypertonic
      glucose versus 75% hypertonic glucose for sclerotherapy treatment of telangiectasis. The
      patients will be examined and clinically classified. It will be included patients with
      telangiectasis sited at out's thigh, and only one extremity will be included per patient. The
      patients with varicose disease CEAP 2 or more will not be included. The treatment will be
      carried out in only one session and the medication volume not exceeding 5 ml. Clinical
      follow-up protocols will be filled on regular visits on days 0 - 7 - 60 concomitantly with
      photograph documentation. Supplementary examination for venous mapping with ultrasound
      pretreatment is performed for all patients.

      Discussion. This prospective controlled double-blind randomized trial aims to verify and
      compare the efficacy and safety for sclerotherapy treatment of telangiectasis of the lower
      limbs. The results may help physicians to choose the best sclerotherapy treatment for
      telangiectasis.
    

Intervention name(s): Glucose; Polidocanol with Glucose
Intervention type(s): Drug; Drug
Intervention description(s): Sclerotherapy of telangiectasis in one lower limb.; Sclerotherapy of telangiectasis in one lower limb.
Other intervention name(s): Hypertonic dextrose; Asclera; Varithena
Intervention MeSH terms: Polidocanol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: telangiectasis; varicose veins; veins; glucose; sclerotherapy
Comparison of Dreem to Clinical PSG for Sleep Monitoring in Healthy Adults
Condition: Sleep
Study type: Interventional

Summary: 
      This study aims to evaluate the accuracy of automated sleep analysis by the Dreem dry-EEG
      headband and deep learning algorithm in comparison to the consensus of 5 sleep technologists'
      manual scoring of a gold-standard clinical polysomnogram (PSG) record in healthy adult
      volunteers during an overnight clinic-based sleep study.
    

Detailed description: 
      The study will enroll 25 adult volunteers who will undergo a one-night in-lab sleep study.
      All volunteers are first prescreened over the phone. Upon arrival at the research center,
      volunteers provide informed consent, are interviewed to confirm eligibility, and complete a
      detailed demographic, medical, health, sleep, and lifestyle survey. After the survey,
      participants are fitted with the PSG and the Dreem headband by the sleep technologist. During
      the PSG sleep study, the Dreem headband records EEG, pulse, oxygen saturation (SO2),
      movement, and respiratory rate.

      Dreem's algorithms will be used to automatically stage the Dreem sleep data, and the results
      will then be compared to the consensus of 5 sleep technologists' manual scoring of the
      respective PSG records for the same individuals to determine the accuracy of Dreem's sleep
      staging algorithms.
    

Intervention name(s): Dreem
Intervention type(s): Diagnostic Test
Intervention description(s): Dreem Band to be worn by each participant while undergoing in-lab sleep study with PSG.
Intervention model: Single Group Assignment
Intervention model description: Dreem
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Automated Sleep Staging
Study of Spino-pelvic Sagittal Balance by Vicon® Optoelectronic System
Condition: Kyphosis
MeSH terms: Kyphosis
Study type: Interventional

Summary: 
      Spinal diseases often induce gait disorders with multifactorial origins such as lumbar pain,
      radicular pain, neurologic complications, or spinal deformities. However, radiography does
      not permit an analysis of spinal dynamics; therefore, sagittal balance dynamics during gait
      remain largely unexplored. This prospective and controlled study try to assess the Vicon
      system for detecting sagittal spinopelvic imbalance and to determine the modification induced
      by ant induced anterior sagittal imbalance on the kinetics walking parameters
    


Intervention name(s): EOS X-rays; 8-meters walk test
Intervention type(s): Radiation; Other
Intervention description(s): EOS X-rays is done with et without a kyphosis induced corset; 8-meters walk test measured by optoelectronic Vicon system with et without a kyphosis induced corset
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Tobramycin 300 mg Once-a-day (o.d.) Aerosol in Adults With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The study will include 10 adult patients with cystic fibrosis. The aim of the study is to
      evaluate whether Tobramycin 300 mg aerosol once-a-day for 28 days can reduce the bacterial
      load in the airways. Secondary end-point is the evaluation of variation in bacterial
      susceptibility during and at the end of study period.
    

Detailed description: 
      Ten adult patients with cystic fibrosis will be enrolled in a stable phase and will received
      prophylaxis with aerosol of Tobramycin 300 mg once a day for 28 days.
    

Intervention name(s): tobramycin
Intervention type(s): Drug
Intervention description(s): inhaled tobramycin 300 mg single dose OD for 28 days
Other intervention name(s): Bramitob
Intervention MeSH terms: Tobramycin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cystic fibrosis; bacterial load; inhaled tobramycin
Safety Study of Clinical Cell Transplant Therapy Using Hearticellgram-AMI for Patients With Acute Myocardial Infarction
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the safety of the previously conducted clinical
      trial cell transplant therapy using Hearticellgram-AMI for patients with acute myocardial
      infarction. This is a follow-up observational study and targeting the subjects who
      participated in the previously conducted clinical trial.
    

Detailed description: 
      The safety evaluation in this clinical trial is performed with variables, such as occurrence
      and severity of adverse events, clinical laboratory tests, vital signs, physical examination,
      cardiac events, and cancer.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects agreed to participate in this follow-up observational study among the subjects (80
        patients:40-test group, 40-control group) who participated in the previously conducted
        clinical trial.
Facial Patterns and Masticatory Symmetries
Condition: Facies
MeSH terms: Facies
Study type: Observational

Summary: 
      The purpose of this study is to evaluate chewing side preference, and lateral asymmetry of
      occlusal contact area and bite force of individuals with different craniofacial patterns
    

Detailed description: 
      Dolichofacial subjects presents poorer mechanical advantage, less efficiency in masticatory
      muscles during mastication and in generating bite force, smaller occlusal contact area and
      masticatory capacity when compared to brachyfacial individuals.

      Wide, bilateral chewing cycles were related to better masticatory performance, however,
      unilateral chewing was reported to be very common in population, and it has been associated
      to lateral asymmetry on bite force and occlusal contact area.

      It has been reported that dolichofacial subjects need greater muscular effort during
      mastication when compared to meso and brachyfacial subjects. This may cause functional
      overloading of weaker masticatory muscles, and may lead to functional asymmetries.
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Students and staff of Piracicaba Dental School, and individuals seeking for dental
        treatment at the same institution
      
Keywords: Bite force; Dental occlusion; Face; Mastication; Morphology
Learning to BREATHE: A Randomized Controlled Trial to Lower Diabetes Risk in Adolescent Girls
Condition: Type 2 Diabetes; Depression; Obesity
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Type 2 diabetes is a chronic disease that puts people at risk for major health problems like
      heart disease. Type 2 diabetes is the most common type of diabetes in adults. However, there
      has been a concerning rise in type 2 diabetes among teenagers. Diabetes develops through poor
      insulin sensitivity, meaning that insulin - an important chemical the body makes to keep
      blood sugar normal - isn't working properly. Type 2 diabetes can be prevented by improving
      insulin sensitivity. Stress is related to insulin sensitivity. Individuals who feel stressed
      have worse insulin sensitivity than individuals who do not feel stressed. In adults,
      decreasing stress leads to improvements in insulin sensitivity, but this hasn't been tested
      in teenagers. The purpose of this study is to find out if taking part in a brief group
      program to decrease stress will improve insulin sensitivity and lower diabetes risk in
      teenage girls.
    

Detailed description: 
      After a screening to determine eligibility, girls are randomly assigned to take part in one
      of two 6-week group programs: 1) Learning to BREATHE - a mindfulness-based program, or 2)
      Colorado Blues - a cognitive-behavioral program. After the group, girls return for three
      follow-up visits over the course of a year. The main outcomes are depressive symptoms and
      insulin resistance. We also are assessing stress, eating behavior, fitness, and mindfulness.
    

Intervention name(s): Learning 2 BREATHE; Colorado Blues
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Mindfulness-based group program; Colorado Blues, Cognitive-behavioral depression prevention group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Adolescent; Diabetes; Depression; Obesity; Stress
A Single Dose Study Investigating The Elimination Of PD-0332334 In Patients Receiving Regular Hemodialysis
Condition: Renal Dialysis; Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      1. Quantify how much PD-0332334 is removed from the blood with hemodialysis

        2. Investigate the pharmacokinetics of a single dose of PD-0332334 in subjects receiving
           regular hemodialysis treatments.

        3. Investigate the safety and tolerability of a single dose of PD-0332334 in subjects
           receiving hemodialysis.
    

Detailed description: 
      Assess the elimination of PD-0332334 from the blood with hemodialysis
    

Intervention name(s): PD-0332334
Intervention type(s): Drug
Intervention description(s): A single, 50 mg oral dose (2 capsules) of PD-0332334 will be administered to each hemodialysis subject
Other intervention name(s): imagabalin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: pharmacokinetics, PD-0332334, hemodialysis, renal dialysis
Comparison of Refined and Crude Indigo Naturalis Ointment in Treating Psoriasis
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare the efficacy and safety of refined indigo naturalis ointment with that of crude
      ointment in treating psoriasis.
    

Detailed description: 
      Our previous studies have shown that topical application of indigo naturalis significantly
      improves psoriatic symptoms. However, patient compliance is hindered because the preparation
      is unsightly and stains clothing.

      To improve patient compliance, we have developed a refined formulation in which closer to
      natural skin tones and less prone to stain clothing. In this study, we evaluated the efficacy
      and safety of this refined form of oil extract ointment and compared the results with those
      of the original crude form of indigo naturalis ointment in treating psoriasis.
    

Intervention name(s): refined indigo naturalis ointment; crude indigo naturalis ointment
Intervention type(s): Drug; Drug
Intervention description(s): The patients applied either refined oil extract or crude indigo naturalis ointmnet topically to each of two bilaterally symmetrical psoriatic plaque lesions for 8 weeks.; The patients applied either refined oil extract or crude indigo naturalis ointmnet topically to each of two bilaterally symmetrical psoriatic plaque lesions for 8 weeks.
Other intervention name(s): refined ointment; Crude ointment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: psoriasis, indigo naturalis
The Effects of Hamstring Stretching With and Without Neural Load on Flexibility, Maximum Isometric Strength and Tibial Nerve Pressure Pain Threshold
Condition: Healthy
Study type: Interventional

Summary: 
      The study will be carried out at the Faculty of Nursing and Physiotherapy of the University
      of Alcala. The study has been approved by the Animal Research and Experimentation Ethics
      Committee of the University of Alcalá. Healthy subjects will be recruited and divided into
      two groups randomly to perform a hamstring stretching program for two months.

      One group will perform a stretch with neural load and the other without neural load, although
      both groups will stretch for the same amount of time, repetitions and subjective sensation.

      Participants will be measured before and after performing their assigned stretch. Then, a new
      post-stretch measurement will be taken after two months, period during which the subjects
      will perform the stretching program on their own. Finally, subjects will be asked to quit the
      stretching program to take a final evaluation measurement after one month of follow-up.

      The objective will be to evaluate the effects of stretching with and without neural load on
      hamstring flexibility (main variable), maximum isometric strength and tibial nerve pressure
      pain threshold.
    


Intervention name(s): Hamstring stretching program with neural load; Hamstring stretching program without neural load
Intervention type(s): Other; Other
Intervention description(s): Participants will perform a hamstring stretch with neural load on their dominant leg. They will stretch five days a week, carrying out two repetitions of one minute each, taking a thirty second break in between. The stretch will be performed in a standing position with their dominant leg on a surface at a mid-thigh height approximately, where their knee is not fully stretched and remains unlocked and their back is in a neutral position. Participants will be encouraged to keep a maximum stretching sensation without feeling any pain. To perform the stretch, different tension parameters will be added in the following order (the next parameter shall not be introduced until the previous one has been exhausted): ankle dorsiflexion, cervical and craniocervical flexion, and hip flexion.; Participants will perform a hamstring stretch without neural load on their dominant leg. They will stretch five days a week, carrying out two repetitions of one minute each, taking a thirty second break in between. The stretch will be performed in a standing position with their dominant leg on a surface at a mid-thigh height approximately, where their knee is not fully stretched and remains unlocked and their back is in a neutral position. Participants will be encouraged to keep a maximum stretching sensation without feeling any pain. To perform the stretch, tension will be added by flexing their hip, keeping their ankle relaxed and their spine neutral.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Phase 3 Open-label Study to Evaluate the Safety of MEDI3250 in Healthy Japanese Children Age 2 Years Through 6 Years
Condition: Healthy Japanese Children Age 2 Years Through 6 Years
Study type: Interventional
Phase: Phase 3

Summary: 
      This open-label, single arm, multicenter study will enroll approximately 100 subjects. The
      study is designed to gather the safety and tolerability data in Japanese children 2 to 6
      years of age that would support approval of MEDI3250 in Japan.
    

Detailed description: 
      For children age 2 years through 6 years, the recommended dosage schedule for intranasal
      administration is 0.2 mL (0.1 mL per nostril). For children not previously vaccinated against
      seasonal influenza, a second dose should be given after an interval of at least 4 weeks.

      For the safety and tolerability endpoint, data will be gathered on solicited symptoms, AEs
      and SAEs.
    

Intervention name(s): MEDI3250
Intervention type(s): Drug
Intervention description(s): MEDI3250
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Safety; Tolerability; MEDI3250; Japanese children
Dose-ranging, PK, Safety, Efficacy Study of Osanetant in Patients With Moderate/Severe VMS Associated With Menopause
Condition: Post-menopausal Vasomotor Symptoms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In this clinical research study, subjects will be given the study drug, ACER-801 (osanetant)
      or placebo (looks like the study drug but contains no active ingredients). The study drug
      works on a receptor in the brain and the intended purpose is for the study treatment of
      moderate to severe Vasomotor Symptoms (VMS) also referred to as hot flashes or flushes
      associated with menopause. Hot flashes are a change in your temperature that occurs due to
      changes in your hormones.
    

Detailed description: 
      This is a Phase 2a, randomized, double-blind, placebo-controlled, dose-ranging study in post
      menopausal women in which the pharmacokinetics, safety and efficacy of ACER-801 (osanetant 50
      mg twice daily [BID], 100 mg BID, and 200 mg BID) will be compared to placebo.

      Subjects will enter a Screening Period to determine eligibility. Subjects will be required to
      complete hot flash diaries for 2 weeks prior to randomization. Eligible subjects will be
      admitted to a Clinical Research Unit and remain in the clinic for 14 days after completion of
      treatment and all study assessments. The study includes a 14 day safety follow-up assessment.
      Subjects will be randomized in a 1:1:1:1 ratio.
    

Intervention name(s): ACER-801 50 mg BID; ACER-801 100 mg BID; ACER-801 200 mg BID; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 50 mg BID (twice daily); 100 mg BID (twice daily); 200 mg BID (twice daily); Placebo
Other intervention name(s): osanetant; osanetant; osanetant; Placebo of ACER-801
Intervention MeSH terms: SR 142801
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized in a 1:1:1:1 ratio to ACER-801 per one of the following dosing schedules prior to dosing:
50 mg BID,
100 mg BID,
200 mg BID, or
Placebo BID
Each arm is administered orally for 14 consecutive days (28 doses).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
An Exploratory Study of ZB-06 as a Vaginal Contraceptive Film
Condition: Contraception
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is an early Phase 1 study to establish proof-of-concept by determining whether an
      intravaginal film containing a human contraceptive antibody (ZB-06) shows promise to provide
      contraceptive efficacy using the post-coital test, a surrogate measure of efficacy. The study
      will also evaluate the safety and pharmacokinetics of ZB-06.
    


Intervention name(s): ZB-06
Intervention type(s): Biological
Intervention description(s): ZB-06 is a polyvinyl alcohol-based film containing 20 mg of human contraceptive antibody (HCA) for topical intravaginal administration.
Intervention model: Single Group Assignment
Intervention model description: This is a Phase 1a, single center, open-label, crossover, mechanism of action and proof of concept study.
Masking: None (Open Label)
Primary purpose: Prevention