bioihbjkbjnl/mcl2 huggingface dataset:
The Relation Between Vitamin D Production and UVB Exposed Body Surface Area
Condition: Vitamin D Status
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the relation between vitamin D production after
      UVB and exposed body surface areas with different UVB doses.
    

Detailed description: 
      Vitamin D deficiency is very common. Rachitis, osteoporosis, cancer, sclerosis as well as
      cardiovascular diseases are related to vitamin D deficiency. Elderly people, immigrants as
      well as patients with malabsorption diseases often have vitamin D deficiency. 90-95 % of the
      total vitamin D requirements are obtained from the ultraviolet (UV) radiation of the skin.In
      spite of the risk of skin-cancer, treatment with sunlight radiation is often recommended
      against vitamin D deficiency. This fact has raised a scientific debate, where concern has
      been expressed with regard to the risk of skin-cancer. This dilemma should also be examined
      as no human studies are available on the vitamin D production in the skin after UV-radiation
      showing the frequency and dose necessary for sufficient production of vitamin D. The lowest
      exposure frequency, the smallest body surface area and the lowest UV dose should therefore be
      established to be exposed in order to minimize the risk of skin-cancer by unnecessary
      UV-radiation. The purpose of the project is therefore to clarify which factors there are of
      importance for the production of vitamin D in the skin after UVB radiation.
    

Intervention name(s): Broadband UVB; Broadband UVB; Broadband UVB; Broadband UVB; Broadband UVB; Broadband UVB; Broadband UVB; Broadband UVB; Broadband UVB
Intervention type(s): Radiation; Radiation; Radiation; Radiation; Radiation; Radiation; Radiation; Radiation; Radiation
Intervention description(s): UVB dose: 0.75 SED. Four UVB sessions with 2 days in between.; UVB dose: 0.75 SED. Four UVB sessions with 2 days in between.; UVB dose: 0.75 SED. Four UVB sessions with 2 days in between.; UVB dose: 1.5 SED. Four UVB sessions with 2 days in between.; UVB dose: 1.5 SED. Four UVB sessions with 2 days in between.; UVB dose: 1.5 SED. Four UVB sessions with 2 days in between.; UVB dose: 3.0 SED. Four UVB sessions with 2 days in between.; UVB dose: 3.0 SED. Four UVB sessions with 2 days in between.; UVB dose: 3.0 SED. Four UVB sessions with 2 days in between.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Vitamin D; UVB; Dose-Response; Body surface area
Clinical Comparison of Two Marketed Reusable Cosmetic Contact Lenses
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This will be a 4-visit, multi-site, randomized, brand-masked, bilateral, 2×2 crossover study.
      If a subject is found to meet all eligibility criteria, they will be randomized to one of two
      lens wear sequences. Each lens type will be worn for approximately 2 weeks.
    


Intervention name(s): ACUVUE® DEFINE™ Vivid Style; LACELLE™ Sparkling Brown
Intervention type(s): Device; Device
Intervention description(s): TEST Lens; CONTROL Lens
Other intervention name(s): etafilcon A; helifilcon A
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Dismantling Mindfulness: Contributions of Attention vs. Acceptance
Condition: Mild-moderate Unipolar Depression; Persistent Negative Affect
MeSH terms: Depressive Disorder
Study type: Interventional

Summary: 
      This study addresses NCCAM's request for research that investigates the neuropsychological
      mechanisms underlying mind-body therapies, and for precise criteria and better delineation of
      meditation practices.

      The purpose of this study is to assess the clinical efficacy and mechanism of action of 2
      component practices of "mindfulness meditation", i.e. focused awareness (FA) and open
      monitoring (OM) in comparison to each other and to the standard package, Mindfulness-Based
      Cognitive Therapy (MBCT).
    

Detailed description: 
      Meditation, particularly mindfulness meditation, is one of the most popular Complementary and
      Alternative Medicine (CAM) therapies for alleviating emotional stress, depression and
      anxiety. While standardized meditation-based treatment packages like Mindfulness Based Stress
      Reduction (MBSR) and Mindfulness-based Cognitive Therapy (MBCT) have reliably shown sustained
      improvements in emotional disturbances and wellbeing, they contain so many different
      components and practices that the active ingredient cannot be ascertained. What is commonly
      called "Mindfulness" meditation is actually comprised of two separate practices: 1) focused
      awareness practice (FA), and 2) open-monitoring practice (OM). This project aims to create
      separate 8 week programs for FA and OM meditations, compare their clinical efficacy and
      investigate their separate mechanisms of action in individuals with clinically significant
      levels of persistent negative affect and depression. The clinical benefit and mechanism of
      action of focused awareness (FA) vs open-monitoring (OM) vs MBCT will be examined with a
      3-armed randomized control trial of these 8 week interventions. Outcome variables include
      negative affect (depression, anxiety, stress) and wellbeing. Hypothesized mediating processes
      include objectively measured attention, emotion regulation and the basic wakefulness on which
      they depend.
    

Intervention name(s): Mindfulness-Based Cognitive Therapy; Focused Attention (FA); Open- Monitoring
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Mushroom Blend on Oxygen Kinetics
Condition: Oxygen Utilization; Oxygen Kinetics
Study type: Interventional

Summary: 
      Purpose: To determine the acute effects of a mushroom blend vs. placebo on oxygen kinetics,
      aerobic power and time to fatigue in healthy adults.
    

Detailed description: 
      Participants: Twenty-eight, healthy, active, recreationally-trained adults ages 18-35.

      Procedures (methods): All subjects will report to the Applied Physiology Laboratory in Fetzer
      Rm 025 for phase I of the study for a total of 7 visits. A randomly selected subset of 8
      participants will continue to phase II, and return to the lab for an additional 3 visits to
      evaluate feasibility. Visit 1 will consist of a physical, enrollment and consenting. Visits,
      2, 3, and 4 will be separated by a minimum of 24 hours. During visit 2, participants will
      perform a maximal oxygen consumption (VO2max) test on a cycle ergometer. During visit 3
      participants will be asked to complete a 6-minute oxygen kinetics test on a cycle ergometer;
      lactate threshold and oxygen saturation will be measured at baseline, minutes 2, 3 and 6
      during the 6 min ride. During visit 4, participants will perform a 3-minute critical power
      (CP) test and will provide a saliva sample, to be measured for cortisol levels, immediately
      prior to and after the CP test. Following visit 4, participants will be randomly assigned, in
      a double-blind fashion, to either a placebo or mushroom blend treatment group. Participants
      in the placebo and treatment groups will be asked to consume 2 servings, 3 times daily for 7
      days. Following supplementation, participants will return to the laboratory for visits 5-7,
      each of which will be separated by a minimum of 24 hours. The same protocol performed during
      visits 2-4 will be repeated in the same order for visits 5-7; the VO 2max test, the 6 min
      oxygen kinetics test, and the CP test with a pre and post saliva sample. The randomly
      selected subset of 8 participants will continue into phase II (n=4 for treatment; n=4 for
      placebo). During phase II, the 8 participants in the placebo and treatment groups will be
      asked to consume 2 servings, 3 times daily for 14 additional days to determine feasibility of
      a longer supplementation phase. Following supplementation, the same protocol performed during
      visits 2-4 will be repeated in the same order for visits 8-10, each of which will be
      separated by a minimum of 24 hours.
    

Intervention name(s): Mushroom Blend; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Scivation
Other intervention name(s): Cordyceps
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: cordyceps, aerobic capacity, exercise performance, fatigue
Fluvastatin, Rosuvastatin Added to Pegylated Interferon and Ribavirin
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      Hypothesis: addition of fluvastatin will increase the cure rate of standard anti-HCV therapy.
      Summary: This trial is limited to veterans in Oklahoma who qualify for care with the Veterans
      Administration. It is a randomized control format including genotypes 1 and 3. There will
      also be pilot arms for HCV carriers who present for screening already on a statin, who will
      be allowed to stay on their current statin or switched to another statin. In all ways,
      standard therapy as noted on pegylated interferon and ribavirin will be given per FDA package
      insert.
    


Intervention name(s): standard of care; fluvastatin
Intervention type(s): Drug; Drug
Intervention description(s): peginterferon/RBV; Add fluvastatin at 20-40 mg/day to standard of care
Other intervention name(s): Lescol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fluvastatin; hepatitis C; chronic hepatitis C; not previously treated with pegylated interferon and ribavirin
Drug Interaction Potential Between Dolutegravir and Simeprevir in HIV/HCV Seronegative Volunteers
Condition: HIV; Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional

Summary: 
      The investigator believes simeprevir concentrations are unchanged when administered in
      combination with dolutegravir relative to administration alone. The investigator believes
      dolutegravir concentrations are unchanged when administered in combination with simeprevir.
      Additionally, the investigator believes simeprevir and dolutegravir are safe when
      administered alone and in combination.
    

Detailed description: 
      To investigate the potential for drug interactions between simeprevir and dolutegravir,
      participants will receive each drug alone and the drugs in combination for 7 days. The
      pharmacokinetics of simeprevir and dolutegravir when given in combination vs. alone will be
      compared.
    

Intervention name(s): dolutegravir; simeprevir
Intervention type(s): Drug; Drug
Intervention description(s): dolutegravir tablets 50mg, once daily x 7 days.; simeprevir tablets 150mg, once daily x 7 days.
Intervention MeSH terms: Dolutegravir; Simeprevir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: dolutegravir; simeprevir; HIV; HCV
Closure of the Uterine Artery at Its Origin vs at the Cervix: a Randomized Trial
Condition: Anatomy; Laparoscopy; Uterine Artery; Hysterectomy
Study type: Interventional

Summary: 
      One of the fundamental surgical steps in patients undergoing laparoscopic hysterectomy is the
      closure of the uterine artery, this vessel provides the greatest blood supply to the uterus.

      This step can be done in two ways: the surgeon can choose to interrupt the blood flow by
      closing the uterine artery in its last part, close to the uterus, or the surgeon can develop
      the anatomical spaces around the uterus into the deep pelvis, closing it to its origin,
      maintaining a minimally invasive approach in both cases.

      Scientific research has tried to establish whether one of the two modalities is the best in
      reducing intraoperative blood loss and possible complications, but currently there is not
      enough evidence to recommend an approach rather than another.

      The investigator has therefore decided to evaluate the results at the end of a laparoscopic
      hysterectomy in a scientifically rigorous manner.
    


Intervention name(s): uterine artery closure
Intervention type(s): Procedure
Intervention description(s): Interruption the uterine blood flow by closing the uterine artery at its cervical-isthmic part or at its origin.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
NovellusDx Functional Profiling of Oncogenic Mutations in Lung Cancer Patients
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Observational [Patient Registry]

Summary: 
      NovellusDx technology identifies tumor-specific driver mutations, but unlike sequencing-based
      tests, NovellusDx has a functional assay that detects dis-regulated translocation of mutated
      signaling proteins to the nucleus. This allows NovellusDx to identify functionally-impactful
      driver mutations regardless of whether the mutation has previously been described or linked
      to a tumor type.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients that are suspected to have lung cancer and are eligible for biopsy, surgical
        intervention or pleural fluid suction.
      
Biospecimen description: 
      Biopsy material of patient or pleural fluids.
    
Keywords: Patient diagnosed with lung cancer
Sedation During Spinal Anesthesia
Condition: Sedation During Spinal Anesthesia
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients during spinal anesthesia should be sedated.
    

Detailed description: 
      Spinal anesthesia offers a number of advantages to both the patient and the physician.
      However, patients are often reluctant to remain awake during a procedure. Sedation has been
      shown to increase patient satisfaction during regional anesthesia and may be considered as a
      means to increase the patient's acceptance.Therefore, provision of adequate sedation is
      important if the advantages of spinal anesthesia are to be fully appreciated.
    

Intervention name(s): Ketamine; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): Patient will receive IV ketamine 0.5 mg/kg diluted in normal saline to a volume of 50 ml over 10 min; Patient will receive IV midazolam 0.03 mg/kg diluted in normal saline to a volume of 50 ml over 10 min
Other intervention name(s): Ketalar; dormicum
Intervention MeSH terms: Midazolam; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Study to Evaluate the Interaction Between a Drug and CNV1014802 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a double-blind, randomised, placebo-controlled 3 period study to evaluate the
      interaction between a drug and CNV1014802 in healthy male and female subjects. It is planned
      to enrol 36 subjects.
    

Detailed description: 
      This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been
      acquired by Biogen.
    

Intervention name(s): CNV1014802
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: volunteer drug interaction study
Mechanisms of Diastolic Dysfunction Among Persons With HIV Compared With Non-HIV Control Subjects
Condition: HIV; Diastolic Dysfunction; Myocardial Fibrosis
MeSH terms: Fibrosis
Study type: Observational

Summary: 
      In this study, investigators plan to test two potential mechanisms contributing to diastolic
      dysfunction among asymptomatic persons with HIV who are on cART. The first proposed mechanism
      is that heightened systemic immune activation/inflammation in HIV contributes to myocardial
      inflammation, which in turn promotes myocardial fibrosis. The second mechanism is that
      ectopic fat deposition (increased visceral adiposity) in HIV relates to increased
      intramyocardial lipid content, which in turn contributes to diastolic dysfunction. Both HIV
      positive and HIV-negative participants will undergo cardiac MRI/ MRS imaging studies for
      evaluation of myocardial fibrosis, myocardial inflammation, and intramyocardial lipid
      content. Traditional markers of CVD risk, inflammatory markers/immune, hormonal markers, and
      markers of myocardial stretch/injury will be assessed in relation to cardiac MRI/MRS
      outcomes. Additionally, a small subset of participants with HIV will undergo longitudinal
      evaluations to assess effects of a clinically prescribed hormonal therapy on myocardial
      structure and function.
    


Intervention name(s): Cardiac MRI/MRS
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        HIV positive and HIV negative participants
      
Biospecimen description: 
      whole blood, plasma and serum
Use of Binaural Beats for Colonoscopy
Condition: Pain
Study type: Interventional

Summary: 
      Investigators verify the effectiveness of "binaural beats" to reduce pain during colonoscopy
      .
    

Detailed description: 
      Colonoscopy is a disturbing and painful procedure, so whenever possible it is performed in
      sedation. Although the use of sedative drugs is effective in relieving anxiety and pain such
      drugs can cause significant side-effects.

      This study examines the effect of Binaural Beats stimulation on pain perception during
      colonscopy.

      Binaural Beats is a simple technique, described for the first time since by Gerald Oster ,
      that include the presentation of two acoustic stimuli with similar frequencies through the
      two channels of stereo headphones. The interference of their waves which occurs at the level
      of the central nervous system, produces a composite signal with a frequency resulting from
      the difference of the two original frequencies. For example if you give an acoustic stimulus
      of 100 Hz to an ear and simultaneously administering another acoustic stimulation of 104 Hz
      to the opposite ,ear the person who listens to these stimuli will perceive a "Binaural Beat"
      of 4 Hz caused by the difference between the two frequencies.

      These Binaural Beats are of interest because they have been thought to cause hemispheric
      synchronization and influence the EEG frequency like light stimulation .

      Binaural Beats have already been used in humans undergoing outpatient surgery in
      urogynecological and have been shown to help increase patient comfort by reducing the state
      of anxiety and pain without interfering negatively with postoperative functional recovery .
      In this study the investigators evaluate the use of Binaural Beat in outpatients to undergo
      colonoscopy to reduce pain .

      A total of 100 patients divided into two groups, 50 treatment and 50 control will be
      considered.

      Both patient groups will be invited to wear headphones regardless of whether they have been
      randomized to Binaural Beats with white noise or white noise only to ensure blindness of
      participation The headphones will be worn ten minutes before and throughout the procedure.
      Pain will be measured by VAS scale and satisfaction by Likert scale after the procedure in
      both groups. Blood pressure and heart rate will be monitored before, during, and after the
      procedure.
    

Intervention name(s): Binaural Beats
Intervention type(s): Device
Intervention description(s): Device: Sound with Binaural Beats at acoustic frequencies of 256 Hz in one ear and 260 Hz in the opposite ear producing a binaural beat of 4 Hz with a white background noise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Binaural Beats; Colonscopy
Efficacy of Artemether/Lumefantrine for the Treatment of Uncomplicated Malaria.
Condition: Plasmodium Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 4

Summary: 
      Artemether-lumefantrine has been used in Tanzania as first-line treatment for uncomplicated
      malaria since 2007. Nonetheless, a report of increased proportion of patients with
      parasitaemia on day 1 following treatment with artemisinin based combination therapies has
      emerged from Kenya. Similarly, resistance against artemisinins has been confirmed in
      South-East Asia and it can spread to Africa. Therefore, the purpose of this study was to
      assess the efficacy of Artemether-lumefantrine for the treatment of uncomplicated malaria
      among children after five years of wide scale use of the drug in Tanzania.
    

Detailed description: 
      Artemisinin based combination therapies (ACTs) are currently recommended by the World Health
      Organization (WHO) as first-line treatment for uncomplicated malaria in all malaria endemic
      countries including Tanzania, that adopted the policy in 2007. ACTs have proven to be highly
      efficacious in different parts of the world with different malaria endemicity. Artemisinins
      clear asexual parasites rapidly and they are also potent against P. falciparum gametocytes,
      hence reducing disease transmission and spread of drug resistance. Nonetheless, a report in
      Kenya shows an increase in proportion of patients with parasitaemia on day 1. Most recently,
      resistance against artemisinins has been confirmed in four countries of South-East Asia, and
      it may spread to Africa.

      In order to safeguard ACTs life span, WHO recommends all suspected malaria cases to be
      confirmed with parasitological diagnosis, followed by prompt treatment with effective
      antimalarials. It also emphasizes on the need to conduct efficacy studies for the first and
      second line antimalarial treatments after every two years so as to be able to detect
      resistance early on its course. Therefore, based on this notion, this study aimed to assess
      the therapeutic efficacy of Artemether/Lumefantrine among children with uncomplicated
      falciparum malaria in Bagamoyo district, five years after its wide scale use in Tanzania.
    

Intervention name(s): Artemether-lumefantrine
Intervention type(s): Drug
Intervention description(s): Blood samples will be collected on blood slides and filter papers for asexual parasites assessment both by microscope and molecular genotyping respectively following treatment with artemether-lumefantrine, to assess its efficacy.
Other intervention name(s): Coartem
Intervention MeSH terms: Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Efficacy; Artemether/lumefantrine; Malaria; Children