bioihbjkbjnl/mcl2 huggingface dataset:
Treatment of Surgical Scars Following Breast Augmentation, Abdominoplasty or Face Lift
Condition: Surgical Scar; Breast Augmentation; Abdominoplasty; Face Lift
Study type: Interventional

Summary: 
      Split-body/face evaluator-blind study of the safety and performance of fractional RF for the
      treatment of surgical scars following breast augmentation, abdominoplasty or face lift. The
      study will enroll up to 50 female subjects requesting treatment of surgical scars following
      breast augmentation or abdominoplasty and up to 25 male and female subjects requesting
      treatment of surgical scars following face lift surgery. Subjects will receive a total of
      three treatments of their surgical scars at one-month intervals on one side of the body or
      face only. Subjects will be followed up at one, two, three and ten months after their last
      treatment. Outcomes will be compared to the non-treated side.
    

Detailed description: 
      Blinded evaluators to determine the efficacy of the study treatment by comparing baseline
      photographs with photographs taken at follow up months 3, 4, 5 and 12 using the Global
      Aesthetic Improvement scale (GAIS), Manchester Scar Scale (MSS) and Patient and Observer Scar
      assessment scale (POSAS).

      Study subjects will also complete a Patient and Observer Scar assessment scale (POSAS) and
      5-Point Likert Satisfaction Scale at baseline and at follow-up month 5 and 12, indicating
      their satisfaction with the study treatment.
    

Intervention name(s): fractional radiofrequency
Intervention type(s): Device
Intervention description(s): Fractional radiofrequency will be delivered to the area of the surgical scar identified to receive the study treatment.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: The subject will act as their own control. Each surgical scar is split into two areas with one side of the scar receiving the study treatment while the other side of the scar remains as the control.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fractional Radiofrequency
Effects of Black Soy Peptide Supplementation on Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      Black soy peptides have been shown to possess properties that may decrease blood pressure. To
      examine the effects of black soy peptides supplementation on blood pressure and oxidative
      stress in subjects with pre-hypertension or stage I hypertension.
    

Detailed description: 
      Trial participants included men and women aged 30 to 65 years who had an average systolic
      blood pressure (SBP) between 130 to 159 mmHg, average diastolic blood pressure (DBP) between
      80 to 99 mmHg, or both, based on an average of six measurements during two screening visits.
      Participants were supplied with 84 pouches of placebo (casein) or black soy peptide (3
      pouches/day) at 0-week and at 4-week visits. Test group subjects received pouches containing
      black soy peptides (4.5 g/day total soy peptides for 8 weeks). The control group received
      pouches containing casein that had a similar appearance to the black soy peptide tablet.
      During the intervention, we instructed study participants to continue their current food
      intake patterns and lifestyles so that total energy intake and energy expenditure would be
      constant during the course of trial. Participants brought back unconsumed pouches at their 4-
      and 8-week follow-up visits. The dietitian counted the number of returned pouches, and we
      used this to assess the participants' adherence to their assigned intervention.
    

Intervention name(s): black soy peptide
Intervention type(s): Dietary Supplement
Intervention description(s): black soy peptide: 4.5g/day for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
A Novel Device for the Management of ADHD
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      This is a 2-months study, where eligible ADHD adult participants will be provided with
      personalized VIZO glasses.
    

Detailed description: 
      This study was designed as a pilot single-center, open-label study of 2 months treatment.
      Following the enrollment, the participants will go through an adjustment process where they
      will be fitted with a personalized pair of VIZO Glasses. The participants will be instructed
      to wear the glasses throughout the day for two months. A follow-up visit at the end of the
      2-month treatment will be conducted to assess the efficacy of VIZO Glasses on managing ADHD
      symptoms, using the Conners Continuous Performance Test-3, the Adult ADHD Self-Report Scale
      (ASRS), Behavior Rating Inventory of Executive Function Adults (BRIEF-A), and Clinical Global
      Impression-Improvement (CGI-I) .
    

Intervention name(s): VIZO Glasses
Intervention type(s): Device
Intervention description(s): Eyeglasses with personalized peripheral retinal stimuli
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD; Peripheral Retinal Stimulation; non-pharmacological
Pediatric Head Lice Study Product Comparison
Condition: Head Lice
MeSH terms: Lice Infestations
Study type: Interventional
Phase: Phase 2

Summary: 
      -  To evaluate the efficacy of LiceMD for the treatment of head lice in a pediatric
           population.

        -  To evaluate the safety of LiceMD in a pediatric population.
    

Detailed description: 
      Head lice, or Pediculus humanus capitis, cause an estimated 6 to 12 million infestations per
      year in the U.S., most commonly affecting children 3 to 11 years of age. Despite common
      perceptions, head lice crawl, and cannot hop or fly. For this reason, transmission occurs
      most often by human head-to-head contact, and much less commonly by the sharing of personal
      items such as hats, coats, combs, or towels. Because head lice feed on human blood, they
      cannot live on pets and are only viable 1-2 days on surfaces other than the human head.
    

Intervention name(s): LICEMD; Standard Head lice product
Intervention type(s): Drug; Drug
Intervention description(s): Parents/guardians of infested children will provide consent for their child's participation. Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment. Participants will be examined for lice count and scalp irritation the day after the first application, and one and two weeks after the first application.; The most common treatments are pesticide-based, over-the-counter remedies of permethrin (1%), or pyrethrin-based products.After baseline scalp exam for lice count and preexisting signs of irritation, parents who agree to the comparison arm may purchase any other head lice treatment of their choice. All treatments are to be done at home by a parent or guardian. All participants will be examined for lice count and scalp irritation the day after the first application, and one and two weeks after the first application. Participants may also be examined by parents or the school nurse at any time if signs of irritation or re-infestation occur. If the child is still found to be infested during any examination, the school nurse will instruct the parent/guardian to retreat.
Other intervention name(s): Generic Name: Dimethicone; permethrin (5%); malathion (0.5%); lindane (1%)
Intervention MeSH terms: Permethrin; Malathion
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lice
Bottle PEP in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      The study aims to investigate the sustainability of Bottle-PEP in patients with cystic
      fibrosis
    


Intervention name(s): Bottle-PEP; Routine physiotherapy
Intervention type(s): Other; Other
Intervention description(s): A device that gives positive pressure from a bottle with the help of a non deflating tube; Routine pulmonary physiotherapy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Effects of Shoe Longitudinal Bending Stiffness
Condition: Runners
MeSH terms: Decompression Sickness
Study type: Interventional

Summary: 
      Carbon plates inserted in competitive running shoes have been increasingly used in the past
      2-3 years and several investigations have shown that these plates increase the longitudinal
      bending stiffness (LBS) of the shoe. It leads to a redistribution of muscle work and to a
      modification of the force generation conditions, which may reduce the energy cost of running
      (Cr) and improve performance.
    

Detailed description: 
      Only one study has investigated the effects of LBS in running bouts longer than 8 minutes but
      on the biomechanics part, and their effects on neuromuscular fatigue and prolonged running
      performance. The aim of this study is to compare shoes with and without carbon plates during
      a prolonged (21 km) running exercise on Cr, plantar flexor neuromuscular fatigue and running
      kinetics and kinematics to estimate the changes high-LBS may induce on fatigue and subsequent
      performance.
    

Intervention name(s): running flexible shoes
Intervention type(s): Other
Intervention description(s): 21kms of running flexible shoes followed by a time-to-exhaustion run.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: NEUROMUSCULAR FATIGUE; ENERGETIC COST OF RUNNING; LONGITUDINAL BENDING STIFFNESS
Iloprost for Prevention of Contrast-Mediated Nephropathy in High-Risk Patients Undergoing Coronary Angiography and/or Intervention
Condition: Renal Insufficiency, Chronic; Coronary Angiography; Angioplasty, Transluminal, Percutaneous Coronary
MeSH terms: Kidney Diseases; Renal Insufficiency; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The prevention of contrast-mediated nephropathy (CMN), which accounts for considerable
      morbidity and mortality, remains a vexing problem. Contrast induced renal vasoconstriction is
      believed to play a pivotal role in the CMN mechanism. The aim of this study is to examine the
      efficacy of the prostacyclin analogue iloprost (dose 1ng/kg/min) in preventing CMN in
      high-risk patients undergoing a coronary procedure.
    


Intervention name(s): Iloprost; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Iloprost 1ng/kg/min IV starting 1 hour before the procedure and continuing for 4 hours after its end; Placebo IV (Normal saline) starting 1 hour before the procedure and continuing for 4 hours after its end
Intervention MeSH terms: Iloprost
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: contrast media; contrast nephropathy
Spray Diathermy Versus Harmonic Scalpel Technique for Hepatic Parenchymal Transection
Condition: End Stage Liver Disease
MeSH terms: Liver Diseases; End Stage Liver Disease
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Consecutive patients, who were treated for end stage liver cirrhosis by LDLT were included in
      this a prospective study.Patients enrolled in the study divided into two groups according to
      the day of surgery. The study population was divided into two groups; group (A) Parenchymal
      liver transection was performed by harmonic scalpel (HS) and group (B) Parenchymal liver
      transection was performed by spray diathermy (SD).
    

Detailed description: 
      Consecutive patients, who were treated for end stage liver cirrhosis by LDLT were included in
      this a prospective study.Patients enrolled in the study divided into two groups according to
      the day of surgery. The study population was divided into two groups; group (A) Parenchymal
      liver transection was performed by harmonic scalpel (HS) and group (B) Parenchymal liver
      transection was performed by spray diathermy (SD).

      Donors and recipient were followed up after hospital discharge with laboratory investigation,
      abdominal ultrasound, MRCP in selected cases every month for the first month, then every 6
      months and then every year postoperatively. Follow up visits included clinical examination,
      laboratory investigation, doses of immunosuppressive, radiological examination, and doppler
      US.

      The primary outcome was the amount of blood loss during transection. Secondary outcomes were
      operative time, time of transection, speed of transection/minutes , number of ligation used,
      degree of postoperative injury which assessed by daily liver function, WBC, C reactive
      protein, pathological changes at the cut surface, postoperative morbidity (including biliary
      leakage, collection), cost and hospital stay.
    

Intervention name(s): harmonic scalpel; spray mode diathermy
Intervention type(s): Device; Device
Intervention description(s): parenchymal liver transection was performed either by harmonic scalpel after demarcation of line of transection by intraoperative US and doppler.; parenchymal liver transection was performed either by spray mode diathermy after demarcation of line of transection by intraoperative US and doppler.
Other intervention name(s): Group A; Group B
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: living donor liver transplantation
Cognitive Effects of Nimodipine in Patients With Schizophrenia
Condition: Schizophrenia; Schizo Affective Disorder
MeSH terms: Schizophrenia; Mood Disorders; Psychotic Disorders
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study aims to evaluate the acute effects of nimodipine on cognitive performance in
      patients with schizophrenia using a battery of cognitive assessments.The subjects will also
      complete a 30-minute structural and functional MRI scan, with the goal of linking brain
      activity with working memory performance. Investigators predict that the performance increase
      induced by nimodipine will be greater in subjects who carry the A allele for the Calcium
      Voltage-Gated Channel Subunit Alpha1 C (CACNA1C) risk single nucleotide polymorphism (SNP)
      (rs1006737) in comparison to the response of G carriers.
    

Detailed description: 
      The main cognitive task of interest in this study is the N-back task because of the observed
      attenuation of prefrontal and parietal cortical activity after nimodipine administration in
      healthy subjects. Investigators hypothesize that acute nimodipine administration will improve
      cortical activation, which will lead to improved cognitive performance. The current study
      will provide insight whether nimodipine or another calcium channel blocker could be used as a
      treatment approach to alleviate cognitive deficits in patients with schizophrenia.
    

Intervention name(s): Nimodipine; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Subject will receive two 30mg capsules of nimodipine during study visit.; Two coconut oil capsules that mimic the size and color of the nimodipine capsules
Other intervention name(s): Nymalize
Intervention MeSH terms: Nimodipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Development of Treatments Aiming at Improvement of Function in Patients With Chronic Widespread Pain
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The study aims to evaluate the effects of adding supervised exercise in supplement to an
      educational self-management program, and to determine which subgroups would gain effects of
      the treatment.
    

Detailed description: 
      164 patients with fibromyalgia and chronic widespread pain were randomized to an
      exercise-education group or to education-only group. The study period was 20 week. The
      primary outcome measures comprised the six-minute walk test and the Fibromyalgia Impact
      Questionnaire. Several other self-administered instruments were included.
    

Intervention name(s): Exercise and education; Education
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Fibromyalgia; chronic pain; physical; exercise; activity; education
Effect of Hepatic Impairment on LDE225..
Condition: Normal Hepatic Function; Impaired Hepatic Function
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate the pharmacokinetics and safety of 800 mg of LDE225 in subjects
      with impaired hepatic function and healthy subjects with normal hepatic function.
    


Intervention name(s): LDE225
Intervention type(s): Drug
Intervention description(s): LDE225
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LDE225; Pharmacokinetics; PK; Postmenopausal women; normal hepatic function; mild hepatic impairment; moderate hepatic impairment; severe hepatic impairment
Blood Levels of Abacavir in HIV Infected Adolescents
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      The way abacavir (ABC) behaves in the body differs between children and adults, but little is
      known about ABC in adolescents. It is unclear if adult doses of ABC are appropriate for
      adolescents. The purpose of this study is to determine the blood levels of ABC in HIV
      infected adolescents who are on ABC-containing regimens.
    

Detailed description: 
      ABC is approved for the treatment of HIV in adults and children, but it is unclear if
      currently recommended ABC doses are appropriate for adolescents. Previous data suggest ABC
      clearance in children is about twice that found in adults, but limited data exist on the
      pharmacokinetics of ABC in adolescents. This study will evaluate the 8-hour pharmacokinetics
      of ABC in HIV infected adolescents who are currently on ABC-containing treatment regimens.

      There will be two groups in this study. Group 1 participants will be 13 to 17 years old.
      Group 2 participants will be 18 to 25 years old. All participants will receive a 300 mg dose
      of ABC as either a single-agent tablet or a combination tablet of ABC, lamivudine, and
      zidovudine (whichever they are currently taking). Participants will have a medical history
      assessment and a physical exam at screening and study entry. Participants will also be asked
      about adherence to their ABC-containing regimen at study entry. During the 8-hour drug level
      study, blood collection for pharmacokinetic analysis will occur prior to taking ABC, and at
      0.5, 1, 2, 3, 4, 6, and 8 hours after taking ABC.
    

Intervention name(s): Abacavir sulfate; Abacavir sulfate, lamivudine, and zidovudine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Lamivudine; Zidovudine; Abacavir; Dideoxynucleosides
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Treatment Experienced
Safety and Efficacy of Cariprazine As Adjunctive Therapy In Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an outpatient study to evaluate the safety, and efficacy of RGH-188 as an add-on
      therapy to standard antidepressants in patients who did not respond to previous
      antidepressant therapy.
    


Intervention name(s): Antidepressant + placebo; Antidepressant + cariprazine (0.1-0.3 mg/day); Antidepressant + cariprazine (1-2 mg/d)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.; Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine (0.1-0.3 mg/d) Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.; Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine (1-2 mg/d) Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.
Intervention MeSH terms: Cariprazine; Antidepressive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Adjunctive; Depression; Major Depressive Disorder (MDD)
An Open-Label, Single-Dose Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of Radiolabeled Androxal in Healthy Male Subjects After Oral Administration
Condition: Secondary Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the route(s) of elimination and mass balance of
      enclomiphene after oral administration of a single 25 mg (approximately equivalent to [(~])
      500 nanocurie [nCi]) dose of [14C]Androxal in healthy adult male subjects.
    

Detailed description: 
      The purpose of this study is to investigate the route(s) of elimination and mass balance of
      enclomiphene after oral administration of a single 25 mg (approximately equivalent to [(~])
      500 nanocurie [nCi]) dose of [14C]Androxal in healthy adult male subjects.
    

Intervention name(s): Androxal
Intervention type(s): Drug
Intervention MeSH terms: Enclomiphene
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment