bioihbjkbjnl/mcl2 huggingface dataset:
A Dose Escalation Study Using Collagenase Clostridium Histolyticum in the Treatment of Lipoma
Condition: Lipoma
MeSH terms: Lipoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research is to evaluate the safest and most effective dose of a Food and
      Drug Administration (FDA) approved drug (XIAFLEX) in the treatment of lipoma (fatty tumors of
      varying sizes that occur commonly in the adult population). The fat in the lipoma is like
      normal fat except that it is enclosed in a balloon-like structure which is made of collagen
      (fibrous tissue). Treatment of the lipoma with an injection of XIAFLEX (a protein that breaks
      down collagen fibers) may dissolve the collagen/fibrous strands thereby decreasing the size
      of the lipoma or removing it.
    

Detailed description: 
      Lipomas are common mesenchymal, benign, fatty tumors of varying sizes that occur in the
      general adult population. They usually present as painful or annoying lumps that are palpable
      and often visible in the subcutaneous tissue. Many subcutaneous lipomas are asymptomatic and
      are removed for non-medical reasons. However, they may cause the subject pain or discomfort
      or interfere with normal activity.

      Spontaneous remission of lipomas has not been reported. A lipoma, once it presents itself,
      remains there for the lifetime of a person who carries it and may stay small or become
      larger. Alternative treatments of the lipoma are surgery or liposuction. If a large excision
      is performed there is the problem of having a very large scar and the accompanying issues of
      healing a large scar, or possible formation of a hematoma followed by consolidation of the
      hematoma and the remnants of a mass of scar tissue. This is often painful and more
      problematic than the original lipoma. liposuction also has the potential for hematoma
      formation followed by scar mass residual.

      To avoid the complications listed above, a non-invasive method of treatment, such as enzyme
      mediated disassociation of adipose tissue, would be desirable. The primary aim of this study
      is to perform a step-wise approach in dosing to evaluate the safety and efficacy of
      clostridium histolyticum as a non-operative treatment for lipoma.
    

Intervention name(s): Collagenase Clostridium Histolyticum
Intervention type(s): Drug
Intervention description(s): This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.
Other intervention name(s): XIAFLEX
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lipoma; Fatty Tumor
Burden of Disease Study In Patients With Transthyretin Familial Amyloidosis Polyneuropathy (TTR-FAP) orTransthyretin Cardiomyopathy (TTR-CM) And Caregivers
Condition: Transthyretin Familial Amyloidosis Polyneuropathy (TTR-FAP); Transthyretin Cardiomyopathy (TTR-CM); Familial Amyloid Cardiomyopathy; Senile Systemic Amyloidosis (SSA)
MeSH terms: Polyneuropathies; Amyloid Neuropathies; Cardiomyopathies; Amyloidosis, Familial; Amyloidosis
Study type: Observational

Summary: 
      This study is an online (web-based) or paper-based survey for patients with transthyretin
      familial amyloidosis polyneuropathy (TTR-FAP) and caregivers. The results will be used to
      describe the emotional, physical, and financial impact of having TTR-FAP or caring for
      someone who has the disease.
    

Detailed description: 
      Convenience sample of patients and caregivers recruited through patient advocacy groups.
      Convenience sample.
    

Intervention name(s): No drug; No drug
Intervention type(s): Other; Other
Intervention description(s): No drug.; No drug.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adults (ages 18-85 years inclusive) diagnosed with TTR-FAP or TTR-CM and experiencing
        symptoms or currently providing care for a patient with TTR-FAP or TTR-CM
      
Keywords: Survey; burden of illness; caregivers; TTR-FAP; TTR-CM; familial amyloid polyneuropathy; observational; transthyretin familial amyloidosis
Efficacy of Iron Bisglycinate in Treatment of Iron Deficiency Anemia in Pregnant Women
Condition: Iron Deficiency Anemia of Pregnancy
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      Anemia in pregnancy is defined by the World Health Organization as hemoglobin levels of ≤ 11
      g/dl. Globally, a prevalence rate of 38% was estimated by the World Health Organization for
      pregnant women.Treatment of iron deficiency anemia during pregnancy remains a main public
      health issue. Oral iron salts have been recommended for treatment of iron deficiency anemia
      e.g. ferrous fumarate. Increasing the dose of ferrous fumarate will subsequently increase the
      bioavailability of iron preparation, however it also increases the frequency of
      gastrointestinal tract side effects e.g. nausea, constipation, diarrhea, flatulence, and
      black stained stools. Besides, the increased bioavailable ferrous fumarate may decrease by
      many foods and / or chelating drugs in the gastrointestinal tract which interfere with its
      absorption leading to variability in the hemoglobin correction during the treatment.

      Ferrous bisglycinate is an iron amino acid chelate. It is formed by reaction of ferrous iron
      with two molecules of the amino acid glycine by a covalent bound in a process called
      chelation. Ferrous bisglycinate is claimed to have better patient compliance because of fewer
      gastrointestinal tract side effects. It is also claimed that ferrous bisglycinate improves
      iron absorption, storage and increase hemoglobin level better than the conventionally used
      iron salts.
    


Intervention name(s): Iron bisglycinate Oral Tablet; Ferrous Fumarate Oral Tablet
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ferrous fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effects of Xylooligosarcharide on Composition of the Human Colonic Microflora
Condition: Bifidobacteria; Healthy Volunteers
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Human and animal studies demonstrate that xylooligosaccharides (XOS) are a highly efficacious
      prebiotic ingredient that delivers benefits at a minimum level of 1.4 g/day (d), which is
      much lower than levels required by fructooligosaccharides (FOS, 5 g/d) or
      galactooligosaccharides (GOS, 8 g/d). XOS promotes gastrointestinal regularity and relieves
      diarrhea and constipation at 0.7 g/d and 1.4 g/d, respectively. Xylooligosaccharides may also
      reduce blood cholesterol and may improve glycemic control, although more data from clinical
      trials are needed to confirm preliminary findings.
    


Intervention name(s): Placebo (Maltodextrin); Xylooligosarcharide 1.4g; Xylooligosarcharide 2.8g
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Maltodextrin 505mg/capsule 8 capsules/day (4 with breakfast and 4 with dinner meal); 8 capsules (512 mg/capsule) 4 with breakfast and 4 with dinner meal; 8 capsules (520 mg/capsule) to be taken in the morning and in the evening
Other intervention name(s): Maltodextrin; XOS 1.4g; XOS 2.8g
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Keywords: XOS; Xylooligosarcharide; Prebiotic
Effects of Virtual Reality on Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      Virtual reality (VR), is one of the most popular approaches to Cerebral Palsy (CP)
      rehabilitation and has been used in rehabilitation field for 30 years. VR is provided via a
      computer or a game console, and players interact with real-like objects . Using a VR
      interface as a rehabilitation tool increases the fun received by the client which, in turn,
      increases the participation of the client to the rehabilitation sessions.

      This is a study that focused on long-term effects of Virtual reality (VR) intervention on
      motor skills and activities of daily living (ADL) independence of children with CP.
    


Intervention name(s): Virtual Reality with Kinect; Conventional Occupational Therapy (COT)
Intervention type(s): Other; Other
Intervention description(s): In the study it was conducted a 12 week-intensive VR intervention (twice a week, 45 minutes each) and compared the results in the 12th week to investigate the effects of rehabilitation and follow-up assessments were made in the 16th and 24th weeks. From the beginning of the VR intervention, each game was played in equal durations by each participant. However, the difficulty of the games varied depending on the child's performance.
Microsoft Kinect Games-Carnival Games was used as VR intervention. In meeting held with the authors to determine which games would be used in the VR program, 5 games were chosen and the remaining games were removed from the program because of their similar contents.; The COT based on neurodevelopmental treatment was carried out by the same occupational therapist. The treatment goals aimed at increasing the use of participant's extremities and improving the independence in ADL. The activities in the treatment were chosen in view of children's motor skills and daily living activities such as getting dressed, solving puzzles, and writing etc.
Both groups received COT while the control group received COT only for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Nighttime Feeding and Morning Endurance Performance
Condition: Poor Performance Status
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the influence of a nighttime feeding on next
      morning running performance, hydration status, and exercise metabolism in female endurance
      athletes. Specifically, the effect of a chocolate milk beverage will be examined versus a
      non-nutritive, flavor-matched placebo. The investigators hypothesize that the nighttime
      consumption of chocolate milk, a whole food complex, will result in improved next morning
      running performance versus placebo. Secondarily, the investigators hypothesize that any
      potential positive performance outcomes from the chocolate milk treatment may be due to an
      enhanced pre-exercise hydration status or improved exercise metabolism.
    

Detailed description: 
      This study will be interventional in nature and employ a crossover, randomized,
      double-blinded approach. This study will include a maximal oxygen uptake test and three
      trials: one familiarization trial, and two experimental trials. The familiarization will
      serve as a practice test to minimize any training effects between experimental trials. The
      experimental trials will be completed within a 2-week period determined by the luteal phase
      of the menstrual cycle (days 15-28 of the menstrual cycle, with day 1 being the first day of
      menstruation). A minimum of 48-72 hours will be provided between testing days.

      Experimental trials will consist of baseline testing (height, weight, urinalysis, resting
      metabolic rate), followed by a treadmill performance protocol. Participants will complete a
      3-stage incremental exercise test (at 55%, 65%, and 75% of maximal oxygen uptake
      respectively). Metabolic data will be collected during this time. Participants will then
      complete a 10-kilometer running time trial in which markers of intensity are monitored at
      various time points (blood glucose, blood lactate, heart rate, rating of perceived exertion).
      Participants and primary researchers will be blinded to all time and speed data. Distance
      will be the only known measure of progress. Additional blood, urine, and body weight measures
      will be taken immediately post exercise.
    

Intervention name(s): chocolate milk; flavor-matched placebo
Intervention type(s): Other; Other
Intervention description(s): 12 oz, 7-8 hours prior to exercise trial (night before); 12 oz, non-caloric flavor-matched placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Evaluation and Correlation of Serum Fetuin-A Levels in Periodontal Health and Disease: A Clinico-biochemical Study
Condition: Gingivitis and Periodontal Diseases
MeSH terms: Gingivitis; Periodontal Diseases
Study type: Interventional

Summary: 
      The present clinico-biochemical study was carried out to estimate the levels of Fetuin A and
      MMP7 in serum of systemically healthy subjects in periodontal health and disease and to
      evaluate the impact of periodontal interventional therapy (scaling and root planing) on the
      same.
    

Detailed description: 
      Sixty sex-matched subjects (30 males and 30 females) belonging to a common age group (30-39
      yrs) were enrolled for the study to eliminate bias from confounding factors. They were
      divided into three groups consisting of 20 subjects in each group based on the clinical and
      radiological parameters; Periodontally healthy (Group I), Chronic gingivitis (Group II) and
      chronic periodontitis ( Group IIIa) from whom serum samples were collected. The Group IIIb
      further comprised of the subjects from Group IIIa, who had received non-surgical periodontal
      therapy (scaling and root planing). Serum samples were collected at baseline and at 12 weeks
      post therapy. Fetuin A and MMP-7 concentration was determined from serum samples of patients
      using ELISA. The results of our study depicted that Fetuin A concentration negatively
      correlates, whereas, MMP7 positively correlates with the extent of periodontal inflammation.
      Further, Periodontal therapy demonstrated a significant increase in serum Fetuin A and
      decrease in MMP 7 levels establishing the influence of periodontal therapy in stabilizing
      their levels.
    

Intervention name(s): Non surgical periodontal therapy
Intervention type(s): Procedure
Intervention description(s): Procedure/Surgery: non surgical periodontal therapy and root planing (SRP) was performed in two to four appointments lasting approximately 60 minutes each under local anaesthesia (2% lignocaine hydrochloride with 1:2,00,000 adrenaline) using area specific Gracey periodontal curettes and an ultrasonic device. The treatment was concluded in 3 months. Within the duration of the study, all subjects received supportive therapy, which included professional plaque control and reinstruction of oral hygiene.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of Lasmiditan When Given With Sumatriptan in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess whether taking lasmiditan and sumatriptan together
      will have any additional effects on heart rate and blood pressure compared to taking
      lasmiditan and sumatriptan individually. This study will also look at the amount of study
      drug that gets into the blood stream and how long it takes the body to get rid of it when
      these two drugs are taken together.

      This study will last about 21 days, not including the screening. Participants will spend 16
      days/15 nights in the clinical research unit (CRU) followed by follow-up. Screening is
      required within 28 days prior to the start of the study.
    


Intervention name(s): Lasmiditan; Sumatriptan; Placebo for Lasmiditan; Placebo for Sumatriptan
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered orally; Administered orally; Administered orally; Administered orally
Other intervention name(s): LY573144
Intervention MeSH terms: Sumatriptan; Lasmiditan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Virtual Peer-to-Peer (VP2P) Support Mentoring for Juvenile Idiopathic Arthritis (JIA): A Pilot RCT
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional

Summary: 
      Study Hypothesis: A virtual peer-to-peer support intervention will improve health outcomes
      and quality of life in adolescents with Juvenile Idiopathic Arthritis
    

Detailed description: 
      The aim of this project is to develop and examine the impact of a virtual peer support
      program on health outcomes and quality of life of adolescents with Juvenile Idiopathic
      Arthritis using a waitlist randomized controlled trial. In addition to standard medical care,
      adolescents in the experimental group will receive a manualized peer mentorship program that
      will provide modeling and reinforcement by trained young adults aged 16-25 years who have
      learned to function successfully with their pain. Mentoring sessions consist of 10 sessions
      of 30-45 minute Skype calls over 8 weeks. Feasibility of the program will be measured in
      addition to quality of life, physical and emotional symptoms, pain coping, self-efficacy,
      social support, and self-management skills.
    

Intervention name(s): Virtual Peer-to-Peer Support Mentoring
Intervention type(s): Behavioral
Intervention description(s): The mentorship program will encourage mentored participants to develop and engage in self-management and transition skills and support their practice of these skills. The mentors will present information to mentored participants in a monitored virtual interaction using Skype for 8 weeks (10 total Skype sessions of 30-60 minutes each) to encourage participation in skill building tailored to their needs. All mentors will complete a paid 2.5 day training course and will be supported throughout the duration of the study (consultations with research staff to deal with unforeseen concerns). Mentored participants will complete online outcome measures prior to randomization (T1) and upon study completion (T2).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Adolescent; Skype; Peer Mentorship; Internet Self-Management
Synbiotic as an Adjunct to Mechanical Treatment of Gingivitis
Condition: Gingivitis; Chronic; Smoking
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the efficacy of oral administration of synbiotic tablets
      on the clinical parameters and the levels of selected inflammatory mediators in gingival
      crevicular fluid (GCF) in smokers and non-smokers with gingivitis.

      This study designed as a double-blind randomized placebo-controlled clinical trial.
    

Detailed description: 
      Some patients like smokers have ongoing host response even after bacterial plaque removal
      achieved. Therefore efforts to develop effective treatment approaches remain an important
      objective in the treatment of gingivitis to prevent periodontitis especially in patients at
      high risk for developing periodontitis as smokers.

      Smoking is a major risk factor for the incidence and the progression of periodontal diseases.
      The increased periodontal disease susceptibility in smokers is predominantly caused by
      changes in inflammatory and immune responses. Cigarette smoking also influences the amount
      and the composition of subgingival plaque. Smokers have higher numbers of pathogens in their
      resident biofilm and display an ongoing host response even after biofilm removal. Different
      approaches were explored to reduce the negative effects of smoking on the outcomes of
      periodontal therapy Synbiotic were defined as a mixture of probiotics and prebiotics that
      beneficially affects the host by improving the survival and implantation of live microbial
      dietary supplements in the gastrointestinal tract, by selectively stimulating the growth
      and/or by activating the metabolism of one or a limited number of health-promoting bacteria,
      and thus improving host welfare. Also in some cases, this may lead to a competitive advantage
      for the probiotics among with other bacteria.
    

Intervention name(s): Synbiotic Supplement; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Other intervention name(s): NOBEL (NBL) Probiotic Optima
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: double-blind randomized placebo-controlled clinical trial
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: gingivitis; gingival crevicular fluid; probiotics; smoking; periodontal medicine
A Phase I Study of HY209 Gel in Healthy Male Volunteers for Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, double-blind, placebo-controlled single and multiple dosing, dose escalation
      phase I clinical trial to investigate the safety/tolerability and pharmacokinetics of HY209
      gel after transdermal administration in healthy male volunteers as a possible treatment
      option for atopic dermatitis
    

Detailed description: 
      A composition containing G Protein Coupled Receptor 19(GPCR19) agonist HY209 and a derivative
      thereof is found to have a considerable effect in the treatment of atopic dermatitis and is
      proposed as a pharmaceutical ingredient for prevention, treatment and improvement of atopic
      dermatitis. The GPCR19 agonist, HY209, is superior to conventional steroid ointment and
      immunosuppressant ointment in the treatment and improvement of allergic dermatitis. It
      directly reduces the amount of serum immunoglobulin E, which is a major factor of allergic
      dermatitis, It increases the T helper type 1(TH1) cytokines that alleviate allergic
      dermatitis pathologies, reduces the T helper type 2(TH2) cytokines that aggravate allergic
      dermatitis pathologies, and reduces the infiltration of mast cells, eosinophils and
      neutrophils into the dermal cells. Thus it can be utilized as a therapeutic drug composition
      for atopic dermatitis.
    

Intervention name(s): HY209
Intervention type(s): Drug
Intervention description(s): 6 subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.
Other intervention name(s): HY209 gel
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized, double blind, placebo-controlled, single and multiple dosing, dose escalation study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: atopic dermatitis