bioihbjkbjnl/mcl2 huggingface dataset:
Therapy of Scars and Cutis Laxa With Autologous Adipose Derived Mesenchymal Stem Cells
Condition: Skin; Scar; Cutis Laxa; Keloid; Cicatrix
MeSH terms: Cutis Laxa; Cicatrix
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is to compare clinical outcomes of patients with large scars or Cutis
      laxa treated with injections of autologous stromal vascular fraction cells (SVF) and
      adipose-derived mesenchymal stem cells (ADSC).
    

Detailed description: 
      Patients suffering from cutis laxa senilis and scars (atrophic, hypertrophic, developed due
      to surgery, trauma, diseases such as acne vulgaris, post-burn scars) will be treated with
      product containing - human autologous stromal vascular fraction (SVF) cells and human
      autologous adipose-derived mesenchymal stem cells (ADSC)
    

Intervention name(s): Laser therapy; Autologous ADSC injection; Normal saline injection
Intervention type(s): Procedure; Biological; Procedure
Intervention description(s): non-ablative fractional laser therapy of skin; Subcutaneous injection of autologous ADSC; Subcutaneous Normal saline injection
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients receive injections of autologous SVF or ADSC cells isolated in the laboratory from adipose tissue.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: scar treatment; cutis laxa treatment; stromal vascular fraction; adipose-derived mesenchymal stem cells
Effects of the Visual Stimulation on the Motor and Visual Cortex in Migraneurs With and Without Aura
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Observational

Summary: 
      The aim of this study is to investigate the motor and visual cortex excitability in response
      to visual stimulation of migraineurs with and without aura compared to healthy individuals.
      For this purpose, electrical cortical activity of migraineurs will be compared to healthy
      volunteers.
    

Detailed description: 
      A cross sectional study to compare the best approach to migraineurs evaluation. For this,
      healthy individuals, after reading and signing the free and informed consent will be
      submitted to a single session to obtain the normal neurophysiological endpoints and thus
      compare with those obtained in individuals with migraineurs volunteers. All volunteers
      (healthy and migraineurs) will be submitted to a neurophysiological evaluation through
      transcranial magnetic stimulation (TMS) and electroencephalography (EEG). A visual
      stimulation will be delivered during the assessment of habituation through visual evoked
      potential volunteers (VEP-habituation) and the following measures will be evaluated before
      and after visual stimulation: (i) Motor Evoked Potentials (MEP); (ii) Motor Threshold (MT);
      (iii) Short Interval Cortical Inhibition (SICI); (iv) Intracortical Facilitation (lCF) and
      (v) Phosphene Threshold (PT).
    

Intervention name(s): Visual Stimulation
Intervention type(s): Procedure
Intervention description(s): volunteers will be invited to sit in a comfortable chair, in a calm and dark room, at 90 cm of distance from computer screen. It will be asked to fix his right eye visual field on a red point at the center of the screen (the left one will be blindfolded). Visual stimuli will be a black and White grid pattern, alternating at a frequency of 3.1 Hz.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients and healthy volunteers will be recruited via advertisements on the university.
        Patients should have migraine diagnosis according to the International Classification of
        Headache Disorders (ICHD-III) criteria and clinical diagnosis by a neurologist.

        For control subjects the individuals should not have migraine diagnosis assessed according
        to IHCD-III criteria.
      
Keywords: migraine disorders; cortical excitability; transcranial magnetic stimulation; electroencephalography
Acute Effects of a Botanical Extract and Its Main Volatile Compound on Stress Response in Healthy Adults
Condition: Healthy
Study type: Interventional

Summary: 
      The prevalence of stress in daily human life increase in the investigator's modern life
      style. Short stress, could be benefit for memory, but prolonged stress may conduct to
      disturbance in cardiovascular, neuroendocrine and central nervous systems. Moreover, it is
      well established that stress is the most common risk factor for the development of mood and
      anxiety disorders, such as major depressive disorder (MDD) and generalized anxiety disorder.
      In response to stress, hypothalamic-pituitary-adrenocortical (HPA) axis is one of activated
      pathway, which induce the cortisol release. Certain natural products could increase
      resilience to stress. Indeed, several preclinical studies have already showed that botanical
      extracts inhibited the typical plasmatic corticosterone elevation induced by an acute stress
      challenge. Therefore, the aim of this clinical trial is to investigate the acute effects of a
      botanical extract and one of his major compound, both delivered as sublingual single dose, on
      cortisol level, cardiac parameters, and psychometric response, in healthy adults exposed to
      an acute psychological stress.
    


Intervention name(s): Botanical extract; Main compound of the botanical extract; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): One capsule; one capsule; Maltodextrin, one capsule
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Analysis of the Vascular Pattern of the Superficial Temporal Artery
Condition: Arteria Temporalis Superficialis
Study type: Observational

Summary: 
      Retrospective analysis to the course and branching pattern as well as surgically relevant
      inner diameters and lengths of the superficial temporal artery (STA) by digital subtraction
      angiographies (DSA).
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        clinic patients who underwent digital subtractions angiographie
Mindfulness Based Cognitive Therapy for Youth With Anxiety at Risk for Bipolar Disorder
Condition: Anxiety; Bipolar Disorder
MeSH terms: Anxiety Disorders; Bipolar Disorder
Study type: Interventional

Summary: 
      Children who have parents with bipolar disorder are at risk for developing anxiety disorders.
    

Detailed description: 
      Children who have parents with bipolar disorder are at risk for developing anxiety disorders.
      Typical treatments for anxiety in children are SSRI antidepressants. However, these
      medications may accelerate the onset of mania or hypomania in children with a family history
      of bipolar disorder or cause suicidal thinking in children. Studies trying alternative
      treatments to anxiety and possible bipolar disorder in children are needed, to establish
      other methods for treating childhood mental health. These studies can also help with early
      intervention and possible future prevention strategies for bipolar disorder. This study
      involves treating anxious children with Mindfulness Based Cognitive Therapy. They will have
      12 weeks of mindfulness therapy in a group with other children where they will be led by a
      trained group leader, how to pay attention to anxiety cues and react differently.
    

Intervention name(s): MBCT-C; Waitlist Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A 12 week group therapy program for children with anxiety disorders. This involves teaching the children the pay attention to anxiety related cues with openness and non-judgment. Group leaders begin each session with: sitting meditation, review of the previous session and home practices, teaching a new mindfulness exercise, reading a group poem or story, distributing handouts, etc. There will be a new theme each week.; Waitlist Control (WC) will be the comparison condition. Some of the children in the study will initially participate in a 12 week WC prior to their participation in the MBCT-C. At each visit during the waitlist control period, participants and their families will receive materials about mood and anxiety disorders in youth, bipolar disorders, familial risk for bipolar disorder and treatment strategies for anxiety and depression in youth.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bipolar disorder; anxiety; mindfulness; high risk; cognitive behavioral
Safety and Efficacy of Vilazodone in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      Safety and Efficacy of Vilazodone in Major Depressive Disorder
    


Intervention name(s): Placebo; Vilazodone; Vilazodone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Matching placebo given orally, once per day; Vilazodone, 20 mg per day, oral administration; Vilazodone, 40 mg once per day, oral administration
Other intervention name(s): Viibryd; Viibryd
Intervention MeSH terms: Vilazodone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Depression
Way to Be Active V (Framing vs. Forgiveness)
Condition: Sedentary Lifestyle
Study type: Interventional

Summary: 
      Employers are increasingly looking for opportunities to motivate sedentary employees to
      become more physically active. Workplace walking programs have had mixed success and
      typically show most improvement among participants that are already fairly active at a
      baseline. The goal of this study is to determine whether a financial incentive program can
      motivate sedentary employees to increase the number of steps they walk per day to meet a
      minimum threshold.

      The primary outcome measure is the proportion of days a minimum activity of 7000 steps or
      more is achieved. Outcomes will be assessed each week for 3 months using incentives followed
      by 3 months of follow-up without incentives. Secondary outcomes will include the average
      steps walked per day.
    


Intervention name(s): Feedback compared to 75th percentile; Forgiveness; Financial Incentive; Daily Feedback
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): For the first three months of the study, a weekly lottery will be held. Teams whose average daily step count for that week is ≥ 7000 will be eligible to collect their lottery winnings. Teams whose average daily step count is less than 7000 will receive messages about how much they would have won had the team met its goal.; Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: Physical activity; Sedentary lifestyle; Pedometers; Walking; Financial Incentives; Behavioral Economics
Trial of Aripiprazole in the Treatment of CD in Adolescents
Condition: Conduct Disorder
MeSH terms: Conduct Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The proposed study will be a 6-week open label study evaluating aripiprazole in the treatment
      of 12 male post-pubertal adolescents (13-17 years, Tanner Stage 4) diagnosed with conduct
      disorder. The initial dose depending on the weight of the patient will be as follows: < 25 kg
      = 1 mg/d; 25-50 kg = 2 mg/d; 50-70 kg = 5 mg/d; > 70 kg = 10 mg/d (Data on File, 2003,
      Bristol-Myers Squibb). For the first two weeks of the study, the dose will be flexible based
      on response and tolerance and thereafter will remain fixed.
    

Detailed description: 
      The use of atypical antipsychotics in children began in 1992 with several small case series
      with clozapine. Since that time, five other atypical agents, risperidone, olanzapine,
      quetiapine, ziprasidone and aripiprazole have been introduced into the US market. The newer
      atypical agents are not associated with agranulocytosis that has limited the usefulness of
      clozapine. Among the atypical antipsychotics, risperidone has remained the most extensively
      studied in children and adolescents, for a variety of problems, including Tourette's
      disorder, conduct disorder, schizophrenia, aggression, and pervasive development disorder.
      Risperidone has been shown to be an effective treatment in many of these disorders. However,
      weight gain, hyperprolactinemia, and extrapyramidal symptoms (EPS) are troublesome adverse
      effects more commonly associated with risperidone such that the drug's utility in this aged
      patient population is limited. We expect that the utility of aripiprazole in treating the
      pediatric population will not be limited by adverse effects like the other atypical
      antipsychotics.
    

Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention description(s): The initial dose depending on the weight of the patient will be as follows: < 25 kg = 1 mg/d; 25-50 kg = 2 mg/d; 50-70 kg = 5 mg/d; > 70 kg = 10 mg/d (Data on File, 2003, Bristol-Myers Squibb). Thereafter the dose will be flexible based on response and tolerance for the duration of the 6 week study. All subjects initially received either a 5 or 10 mg/d (7.0 ± 2.6 mg/d) dose of aripiprazole. Thereafter the dose was individualized based on response and tolerance. Maximum dose was 20 mg.
Other intervention name(s): Abilify
Intervention MeSH terms: Aripiprazole
Intervention model: Single Group Assignment
Intervention model description: open label trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aripiprazole
Efficacy and Tolerability of Armodafinil in Adults With Excessive Sleepiness Associated With Shift Work Disorder
Condition: Excessive Sleepiness
MeSH terms: Disorders of Excessive Somnolence; Sleepiness
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of the study is to determine whether armodafinil treatment is more
      effective than placebo treatment in patients with excessive sleepiness associated with shift
      work disorder (SWD) by measuring improved clinical condition late in the shift, including the
      commute home.
    


Intervention name(s): Armodafinil; Matching Placebo
Intervention type(s): Drug; Drug
Intervention description(s): At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.; At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
Other intervention name(s): R-modafinil; CEP-10953
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Olanzapine in the Treatment of Anorexia Nervosa
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Interventional
Phase: Phase 4

Summary: 
      This study compared 10 weeks of treatment with olanzapine versus placebo in adolescent
      females with anorexia nervosa-restricting type who were undergoing acute treatment on an
      inpatient unit or a day hospital program that specializes in the treatment of eating
      disorders.
    


Intervention name(s): olanzapine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): flexibly dosed oral olanzapine 2.5 to 15 mg/day
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: anorexia nervosa, treatment, adolescents, olanzapine
Safety and Acceptability of a Vaginal Microbicide
Condition: HIV Infections; Hepatitis B, Chronic
MeSH terms: Hepatitis B; Hepatitis B, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and acceptability of a vaginal
      microbicide in HIV uninfected sexually active women.

      Study hypothesis: The vaginal microbicide 1% tenofovir will be safe and well tolerated in HIV
      uninfected women who are in good general health.
    

Detailed description: 
      While the male condom is effective in preventing sexual transmission of HIV, its use is
      hampered by deeply rooted cultural and social barriers. About half of all HIV infections
      worldwide occur in women, yet the only available female-controlled method of HIV prevention
      is the female condom. Alternative prevention tools, such as vaginal microbicides, are
      urgently needed to slow the rapid spread of heterosexual HIV infection.

      This study will last 24 weeks, with an additional 10 weeks of follow-up for participants with
      chronic hepatitis B virus (HBV) infection. Participants will be randomly assigned to one of
      four arms. Arm A participants will insert a vaginal tenofovir 1% gel two hours prior to
      vaginal intercourse for a maximum of two daily applications. Arm B participants will insert a
      vaginal placebo gel two hours prior to vaginal intercourse for a maximum of two daily
      applications. Arm C participants will insert a vaginal tenofovir 1% gel once daily at bedtime
      or during the longest period of daily rest. Arm D participants will insert a vaginal placebo
      gel once daily at bedtime or during the longest period of daily rest.

      A medical and menstrual history update, pregnancy test, HIV and sexually transmitted
      infections (STI) risk reduction counseling, and interview to assess behaviors toward vaginal
      gel use will occur during all study visits. HIV/STI counseling and testing, urinalysis, and
      blood collection will occur at study entry and at Week 24. Pelvic exam with colposcopy and
      vaginal swab collection will occur at study entry and Weeks 4, 12, and 24. For participants
      with chronic HBV, additional blood will be collected to monitor hepatitis B infection at
      study entry and Weeks 12, 24, 28, 32, and 36.
    

Intervention name(s): 1% tenofovir gel
Intervention type(s): Drug
Intervention MeSH terms: Tenofovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Anti-Infective Agents, Local; HIV Seronegativity; Tenofovir; Vaginal gel; Microbicide; Vaginal Microbicide; PMPA
A Double-blind Placebo-controlled Randomized Trial Evaluating the Efficacy and Safety of a Novel HSP90 Inhibitor (RGRN-305) in the Treatment of Moderate to Severe Hidradenitis Supppurativa.
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 16-week treatment, randomized, double-blind, proof-of-concept study designed to
      assess the safety and efficacy of RGRN-305 compared to placebo for use in future efficacy
      Phase 2 trials.

      Male or female subjects aged 18 years or older with moderate to severe hidradenitis
      suppurativa will be included in this study.

      Objectives are to determine the efficacy and safety of RGRN-305 in patients with moderate to
      severe hidradenitis supppurativa.
    


Intervention name(s): RGRN-305; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Heat shock protein 90 inhibitor; Placebo (blinded)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Musculoskeletal Pathologies of the Upper Extremity in Surgical Device Mechanics
Condition: Musculoskeletal Diseases or Conditions
MeSH terms: Musculoskeletal Diseases
Study type: Observational

Summary: 
      Work-related upper extremity musculoskeletal disorders (WRUEMSDs) have shown to be related to
      many occupational situations and specific industries. However, there is conflicting
      information about monotonous and repetitive activities. In this context, the profession of
      surgical device mechanics has not been analyzed so far.

      The objective of this study is to examine surgical device mechanics at different workplaces
      with varying work contents and to compare them with a control group without the repetitive
      workload exposition as described above. The headquarters and main production site of Aesculap
      are located in Tuttlingen/Germany. Aesculap is the world leading manufacturer of surgical
      devices.

      After statistical power analysis, the investigators plan to randomize and include a total of
      90 voluntary test persons in 3 groups (30 persons each). The study will include standardized
      questionnaires and a physical examination as well as an industry test (Purdue Pegboard Test).

      Primary and secondary endpoints were defined to show if significant difference between
      surgical device mechanics and a control group is present.
    


Intervention name(s): Clinical examination and data processing of questionnaires
Intervention type(s): Other
Intervention description(s): xy
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Employees of the Aesculap AG, world leader in production of surgical devices
      
Keywords: musculoskeletal disorders; upper extremity; work; surgical instruments