bioihbjkbjnl/mcl2 huggingface dataset:
Local Pharmacokinetics and Tolerability of Bimatoprost Applied to the Scalp of Male Patients With Androgenetic Alopecia
Condition: Androgenetic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the skin pharmacokinetics and tolerability of bimatoprost
      Formulation A and Formulation B following 14 days of once daily topical administration in
      male participants with androgenetic alopecia (AGA).
    

Detailed description: 
      Single-center, multiple-dose study evaluting the local pharmacokinetics and tolerability of
      bimatoprost following 14 days of once daily topical administration of bimatoprost Formulation
      A and Formulation B (both containing 1% bimatoprost) to the scalp of male patients With
      androgenetic alopecia
    

Intervention name(s): Bimatoprost 1% Formulation A; Bimatoprost 1% Formulation B
Intervention type(s): Drug; Drug
Intervention description(s): Bimatoprost 1% Formulation A solution applied to the scalp and trunk once daily for 14 days.; Bimatoprost 1% Formulation B solution applied to the scalp and trunk once daily for 14 days.
Intervention MeSH terms: Bimatoprost
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Integrated Alcohol and Sexual Assault Intervention for College Men
Condition: Alcohol Drinking; Sexual Assault
MeSH terms: Alcohol Drinking
Study type: Interventional

Summary: 
      This research will evaluate a new intervention that integrates evidence-based alcohol
      intervention strategies and promising sexual assault prevention strategies with the goal of
      decreasing sexual aggression among men who report heavy drinking; a particularly high risk
      group. Specifically, this study will conduct a randomized controlled pilot trial with college
      men who report heavy drinking to demonstrate the feasibility and acceptability of the
      proposed intervention. The main questions the study will answer are: 1) what is the
      feasibility of the recruitment plans, research design, intervention training methods, and
      delivery of the program?; and 2) does the intervention, relative to a mindfulness-based
      control condition, produce reductions in the quantity and frequency of alcohol use,
      perpetration of sexual aggression, and attitudes associated with sexual aggression over the
      2- and 6-month follow-up. Follow-up assessments are completed at 2- and 6-months following
      the program. The intervention is compared to the mindfulness-based control group.
    


Intervention name(s): SAFE; Mindfulness-Based Control Condition
Intervention type(s): Behavioral; Behavioral
Intervention description(s): SAFE includes a motivational interviewing session addressing alcohol use and risk for sexual aggression, a workshop addressing alcohol use and sexual aggression, and a booster session review.; The program includes the same amount of contacts as SAFE, including an individual session focused on mindfulness and stress, a group session, and a booster session review.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Subjective Efficacy of Ramelteon on Sleep in Adults With Chronic Insomnia.
Condition: Chronic Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the subjective treatment effects of ramelteon, once
      daily (QD), on sleep using a post sleep questionnaire-interactive voice response system in
      adults with chronic insomnia.
    

Detailed description: 
      Approximately 60 to 70 million adults in the United States alone are affected by insomnia.
      Daytime symptoms of insomnia include tiredness, lack of energy, difficulty concentrating, and
      irritability. Recent epidemiologic research focusing on the quality of life has identified
      significant insomnia-related conditions that relate to work productivity, health care
      utilization, and risk of depression. Insomnia is associated with diminished work output,
      absenteeism, and greater rates of accidents.

      Ramelteon is marketed for the treatment of insomnia characterized by difficulty with sleep
      onset under the brand name of Rozerem™.

      This study will be comprised of two groups of subjects, 1) an outpatient group and 2) an
      inpatient group. The inpatient group will be used as reference arm as previously conducted
      studies in the sleep laboratory setting. Study participation is anticipated to be about 50
      days (approximately 1.75 months).
    

Intervention name(s): Ramelteon; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ramelteon 8mg, tablets, orally, once nightly for up to 28 days.; Ramelteon placebo-matching tablets, orally, once nightly for up to 28 days.
Other intervention name(s): TAK-375; Rozerem™
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Insomnia; Sleep Initiation and Maintenance Disorder; Drug Therapy
A Phase II, Trial to Assess the Safety and Tolerability of Influenza Virus Vaccine, CAIV-T in Healthy Children and Adolescents Ages 6 to Less Than 18 Years.
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      A safety study to compare, over a 7 day period, the fever rates following one dose of either
      Influenza Virus Vaccine or placebo administered outside the influenza season to healthy
      children and adolescents aged 6 to less than 18 years.
    

Detailed description: 
      This was a prospective, randomized, double-blind, placebo-controlled, study. Subjects were
      randomized to receive either CAIV-T or Placebo. All subjects were healthy children and
      adolescents aged at least 6 years of age and less than 18 years of age at the time of
      enrollment.
    

Intervention name(s): Cold-adapted influenza vaccine trivalent (CAIV-T); Placebo
Intervention type(s): Biological; Biological
Intervention description(s): The total volume of 0.2 ml was administered intranasally with a spray applicator (approximately 0.1 ml into each nostril). Each dose of CAIV-T used in this study contained approximately 10^7+/-0.5 fluorescent focus units (FFU) (equivalent to 10^7+/-0.5 TCID50) of each of the following three influenza virus strains: Influenza Cold Adapted Virus Type H1N1, strain A/New Caledonia/20/99; Influenza Cold Adapted Virus Type H3N2, strain A/ Panama/2007/99; Influenza Cold Adapted Virus Type B, strain B/Hong Kong/ 330/01.; The placebo consisted of physiologic normal saline.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Evaluating the Efficacy and Safety of Fluticasone Furoate/Vilanterol Trifenatate in the Treatment of Asthma in Adolescent and Adult Subjects of Asian Ancestry.
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomised, double-blind, placebo-controlled, parallel group multicentre study to evaluate
      the efficacy and safety of fluticasone furoate/vilanterol trifenatate (FF/VI) inhalation
      powder delivered once daily for 12 weeks in the treatment of asthma in adolescent and adult
      subjects of Asian ancestry currently treated with lowe to mid-strength inhaled corticosteroid
      or low-strength combination therapy.
    

Detailed description: 
      This will be a randomised, double-blind, placebo controlled, parallel group, multi-centre
      study. At Visit 1 (Screening Visit) subjects who meet all of the inclusion criteria and none
      of the exclusion criteria will enter a two week run-in period. Subjects will remain on their
      current ICS therapy throughout the run-in period. At the end of the run-in period (Visit 2)
      subjects meeting the Randomisation criteria will enter a 12 week treatment period and receive
      one of the two following treatments: 1) FF/VI (100/25mcg) administered once daily in the
      evening via a Novel Dry Powder Inhaler (NDPI) 2) Placebo administered once daily in the
      evening via a NDPI In addition, all subjects will be supplied with albuterol/salbutamol
      inhalation aerosol to be used as required to treat asthma symptoms.

      Subjects who have not met the randomisation criteria at Visit 2 will be withdrawn from the
      study.

      Subjects meeting the randomisation criteria will be randomized to one of the two treatment
      groups and will attend the clinic for 3 on-treatment visits at Week 4 (Visit 3), Week 8
      (Visit 4) and Week 12 (Visit 5). Subjects will receive treatment for 12 weeks. A Follow-up
      Visit or phone call (Visit 6) will take place 1 week after completing study medication. All
      clinic visits will take place in the morning. Subjects will participate in the study for a
      maximum of 15 weeks (Screening to Follow-up inclusive). A subject is regarded to have
      completed the study if they complete all phases of the study (Screening, treatment,
      Follow-up).
    

Intervention name(s): GW685698/GW642444 (fluticasone furoate/vilanterol trifenatate); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ICS/LABA combination (100/25mcg) administered once daily in the evening via a Novel Dry Powder Inhaler (NDPI); Placebo administered once daily in the evening via a NDPI
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Combination of Paroxetine CR and Quetiapine for the Treatment of Refractory Generalized Anxiety Disorder
Condition: Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine the safety and efficacy of quetiapine for generalized
      anxiety disorder patients who remain symptomatic despite treatment with paroxetine CR.
    

Detailed description: 
      Generalized anxiety disorder (GAD) is a relatively common condition affecting 5% of the
      population, with a typically chronic course and associated with significant psychosocial
      impairment and decreased quality of life (Schweizer, 1995). Although a number of therapeutic
      agents demonstrate some efficacy in the treatment of generalized anxiety disorder, only a
      minority of anxious patients experience remission with initial treatment.

      The purpose of this study is to examine the efficacy of one strategy, the addition of
      quetiapine, for the treatment of patients with GAD who remain refractory despite an adequate
      treatment trial with a selective serotonin reuptake inhibitor (SSRI). This is an
      investigator-initiated augmentation study of an already approved drug for a different
      indication. Quetiapine is a novel antipsychotic agent with potent effects at the
      serotonergic, as well as dopaminergic receptor, and a more favorable side effect profile than
      standard neuroleptics, including a low potential to cause extrapyramidal symptoms.

      This is a two phase, 18-week research study in which participants who remain symptomatic at
      the end of one phase (10 weeks) enter into the next phase. In phase I, all participants
      receive paroxetine CR (Paxil CR) for 10 weeks. Participants who continue to have anxiety
      symptoms will enter the 8-week Phase II, in which they continue taking Paxil CR and they will
      also be randomly assigned (by chance, like a flip of a coin) to receive quetiapine (Seroquel)
      or placebo (contains no active medication).
    

Intervention name(s): Continued Paroxetine CR; Quetiapine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Quetiapine Fumarate; Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: generalized anxiety disorder; pharmacotherapy; treatment refractory; double-blind
Alleviating Effects Against Dry Eye by Oral Intake of Cordyceps Cicadae Mycelia
Condition: Dry Eye; Supplement
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional

Summary: 
      Cordyceps cicadae mycelia was tested for amelioration of dry eye symptoms through dietary
      supplementation. Its efficacy in relief of human dry eye status was assessed by randomized,
      double-blinded tests, including multiple assessments. The results were compared between the
      placebo group and the experimental group.
    

Detailed description: 
      Former animal studies had shown that Cordyceps cicadae mycelia can effectively ameliorate
      UVB-induced dry eye symptoms. This study further investigated its efficacy in human dry eye
      status by randomized, double-blinded tests, including dry eye questionnaires, blood tests,
      salivary tests, tear volume test, intra-ocular pressure assessments, ocular surface
      photography, corneal fluorescein stain, tear film breakup time test, fundus photography, and
      cornea impression cytology. All tests were performed again after 3 months of dietary
      supplement of either samples or placebo. A total of 97 participants completed the trial. The
      data were analyzed by paired-t test and compared between the placebo and the experimental
      groups.
    

Intervention name(s): Cordyceps Cicadae Mycelia; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Cordyceps Cicadae Mycelia supplement for 3 months; Placebo was given to participants.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized double-blinded placebo study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Dry Eye; Cordyceps cicadae mycelia
Study Evaluating Prophylaxis Treatment & Characterizing Efficacy, Safety, & PK Of B-Domain Deleted Recombinant FVIII
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research study is to determine the effectiveness, safety, and
      pharmacokinetics (PK) of moroctocog alfa (AF-CC) in previously treated subjects, who are
      younger than 6 years of age, with severe or moderately severe hemophilia A.
    


Intervention name(s): Moroctocog alfa (AF-CC); Moroctocog alfa (AF-CC)
Intervention type(s): Biological; Biological
Intervention description(s): On-demand therapy for 6 months, followed by routine prophylaxis 25 IU/kg, administered every other day for 1 year.; Routine prophylaxis crossover:
45 IU/kg, administered 2 times a week for 1 year followed by 25 IU/kg administered every other day for 1 year, or, 25 IU/kg, administered every other day for 1 year, followed by 45 IU/kg, administered 2 times a week for 1 year.
Other intervention name(s): Xyntha; Xyntha
Intervention MeSH terms: Factor VIII
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Timecourse of Immobilization Experiment
Condition: Muscular Atrophy
MeSH terms: Muscular Atrophy
Study type: Interventional

Summary: 
      The effect of unilateral lower limb immobilisation over one week on muscle atrophy
    

Detailed description: 
      This study aims to assess the effect of one week of unilateral leg immobilization on
      quadriceps muscle volume and muscle protein synthesis rates. Participants wore a leg brace on
      one leg and ambulated on crutches during the immobilization period. Thirteen healthy young
      males were recruited to undertake this study.

      It is currently understood that unilateral leg immobilization will result in a reduction in
      muscle size (Berg et al., 1996, Wall et al., 2015) and muscle protein synthesis rates after a
      period of disuse (de Boer et al., 2015, Glover et al., 2008). Recent research in this area
      has shown that even short term periods of leg immobilization (i.e. <1 week) will result in
      reductions in muscle size and muscle protein synthesis rates after the period of disuse (Wall
      et al., 2015). However we currently do not have detailed information on how muscle disuse
      affects muscle size and muscle protein synthesis over time during short term disuse (e.g. the
      first week).

      The stable isotope tracer deuterium oxide (D2O) will be applied to assess cumulative muscle
      protein synthesis between days 0-2, 2-7 and 0-7 of the immobilization period in both the
      immobilized and non immobilized legs. This will be in-conjunction with bilateral vastus
      lateralis muscle biopsies before and after 2 and 7 days of immobilization. Furthremore,
      quadriceps muscle volume was assessed via MRI scans that again occured before and after 2 and
      7 days of immobilization. To gain a mechanistic insight on the molecular changes during
      disuse a custom designed 48 well Taqman low density microarray genecard was applied to assess
      the transcriptional response on genes involved in muscle protein synthesis and breakdown.
    

Intervention name(s): Lower limb immobilisation (leg brace)
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Efficacy of PreOperative Bevacizumab for Diabetic Eye Disease
Condition: Proliferative Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Study type: Interventional

Summary: 
      Reports of the use of intravitreal bevacizumab (Avastin, Genentech) for the reduction of
      neovascularization in proliferative diabetic retinopathy have demonstrated significant
      regression in the number of new vessels. Reducing the vascularity of neovascular
      fibrovascular tissue can potentially reduce bleeding intraoperatively and thus facilitate the
      vitrectomy procedure. The investigators chose to investigate the potential benefit of the use
      of preoperative bevacizumab in the management of these most complex cases.
    

Detailed description: 
      PURPOSE: To evaluate the role of preoperative intravitreal bevacizumab as an adjunct to
      vitrectomy in the management of severe diabetic eye disease.

      SETTINGS: Kasr El-Aini Teaching Hospital - Cairo University from 2007 to 2008. METHODS:
      Twenty eyes of 19 patients with severe proliferative diabetic retinopathy were recruited into
      the study. All eyes underwent a single intravitreal injection of bevacizumab 1.25 mg in 0.05
      ml one week prior to vitrectomy for tractional (14), combined tractional/rhegmatogenous
      retinal detachment (4), and fibrovascular tissue covering/distorting the macula (2).
      Exclusion criteria were: previous vitrectomy, neovascular glaucoma, and dense media opacity
      (dense cataract and vitreous hemorrhage) precluding fluorescein angiography (FA) that was
      done pre- and 1 week post injections. Best corrected visual acuity (BCVA), anterior segment
      with dilated fundus examinations, and intraocular pressures (IOP), were done pre-, 1 week
      post-injections, 1 day, 1 week and monthly for 3 months post-vitrectomy. Intra- and
      post-operative bleedings were recorded.
    

Intervention name(s): Bevacizumab
Intervention type(s): Drug
Other intervention name(s): Avastin
Intervention MeSH terms: Bevacizumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Proliferative Diabetic Retinopathy; Vitrectomy; Bevacizumab
Plasma MicroRNA for Prediction of Hepatocellular Carcinoma
Condition: Hepatitis C
MeSH terms: Hepatitis C; Carcinoma, Hepatocellular
Study type: Observational

Summary: 
      100 patients with diagnosed HCV were evaluated by clinical and ultrasound examination and
      were categorized as uncomplicated HCV (n=22) and complicated HCV (n=78). All patients were
      evaluated for hepatosteatosis and liver fibrosis using the computerized hepatorenal index,
      the hepatic steatosis index, aspartate aminotransferase (AST)/platelet count index (APRI) and
      the Fibrosis-4 (FIB-4) scores. Blood samples were obtained for estimation of serum levels of
      liver function tests and plasma levels of microRNA 21 and 126.
    


Intervention name(s): Blood Sampling
Intervention type(s): Biological
Intervention description(s): Blood sampling under a complete aseptic conditions
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        HCV patients
      
Biospecimen description: 
      MicroRNAs (MiR) are naturally occurring short, noncoding RNAs that specifically regulate
      protein expression and its cumulative effects may lead to broad changes to cell systems and
      architecture. Deregulated expression levels of MiRs may underlie the development of multiple
      liver pathologies
Influence of U-relax on Vaginal Health Promotion and HPV DNA Test Change From Positive to Negative
Condition: Human Papillomavirus; Vaginal Infection
MeSH terms: Infections
Study type: Interventional

Summary: 
      The purpose of this study is to understand the effect of using oral U-relax on HPV infected
      women for vaginal environment health promotion, and the HPV DNA Test Index change from
      positive to negative. Long-term infection of HPV is associated with cervical cancer. U-relax
      contains Lactobacillus GR-1 and Lactobacillus RC-14 and has been approved of its benefits on
      treatment of BV, UTI, IBD and can improve vaginal environment health. Patients with positive
      result of HPV DNA test have no appropriate and aggressive treatment to reduce the risk of
      cervical cancer. This clinical trial tries to reveal the influence of oral U-relax and
      patients with HPV DNA test positive result.
    

Detailed description: 
      This study is a prospective, double blind, randomized clinical trial. Vaginal health
      screening and HPV DNA Test are carried out from 80 patients with positive HPV DNA Test after
      conization for 6 months. All these patients will participant this study during the 360-day
      trial period. All health related conditions will be monitored at the same time.
    

Intervention name(s): U-relax
Intervention type(s): Dietary Supplement
Intervention description(s): Oral U-relax Day 1-5: 2 capsuals before sleep Day 6-360: 1 capsual before sleep
Other intervention name(s): GR-1 and RC-14
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: U-relax Group: U-relax capsules Day 1-5: take two capsuals of oral U-relax everyday before sleep Day 6-360: take one capsule of oral U-relax everyday before sleep
Control Group: Placebo capsules Day 1-5: take two capsuals of oral placebo everyday before sleep Day 6-360: take one capsual of oral placebo everyday before sleep
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Oral Probiotics; HPV DNA Index Test; Vaginal infection