bioihbjkbjnl/mcl2 huggingface dataset:
Out-patient Wake Therapy, Light Therapy and Sleep Phase Advance for Depression
Condition: Unipolar Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Depressed patients miss a night of sleep (Wake Night), then sleep at predetermined times
      ending at their desired sleep time. Beginning the morning following their Wake Night,
      patients sit in front of a bright light, continuing morning bright light and specified sleep
      time for six weeks with weekly visits measuring depressive symptoms.
    

Detailed description: 
      Nonpsychotic, nonbipolar, physically healthy depressed patients keep sleep, mood and energy
      logs for a week, complete the Morningness-Eveningness Questionnaire (measuring "morningness"
      and "eveningness") and determine the time patients want to sleep. Patients then miss a night
      of sleep and subsequently are allowed later and later sleep times until patients are sleeping
      at their desired time. Beginning the morning following their Wake Night, patients sit in
      front of bright lights at their intended wake-up time for the next six weeks and once their
      allowed sleep time is their intended sleep time, patients also continue to only be allowed to
      sleep between those times (e.g., 11 p.m. to 7 a.m.). Daily sleep, energy and mood logs and
      activity monitoring are maintained throughout with weekly clinician ratings. In additional,
      daily telephone check ins occur during the first week following the Wake Night both to be
      sure the patient is following the protocol and to obtain symptom ratings. Saliva to be
      measured for melatonin is collected prior to and following sleep adjustment.
    

Intervention name(s): Triple Therapy
Intervention type(s): Other
Intervention description(s): The intervention consists of three interventions: missing a night of sleep, early morning bright lights and sleep phase advance
Other intervention name(s): Chronotherapeutics
Intervention model: Single Group Assignment
Intervention model description: All patients receive Chronotherapy, which consists of a night of no sleep ("Wake Therapy") followed by bright lights at their desired sleep time and two nights of Sleep Phase Advance (i.e., sleeping 6 hours earlier than desired for 1 night and 3 hours earlier for the next night, then desired sleep time).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: depression; melatonin; light therapy; Wake Therapy; chronobiology
Assessing the Role of a Fermented Soy Extract in Inflammation and the Human Microbiome
Condition: Obesity
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      The consumption of fermented soy foods can alter the human microbiome and may confer health
      benefits. Researchers propose a line of inquiry to assess the effects of Q-Can Plus ("QC")
      fermented soy beverage in humans, assessing immunological, microbiological, and clinical
      parameters.
    

Detailed description: 
      The study will start with a detailed testing of the microorganisms present in the QC
      fermented soy liquid, using deep sequencing. Subsequently, the researchers will determine the
      effect of the QC fermented soy product on the microbiome and inflammation in lean and obese
      individuals, as obese individuals are known to have dysbiosis. The work on inflammatory
      changes will be supplemented by studies to investigate the cellular and molecular mechanistic
      pathways responsible for the biological action of QC fermented soy liquid.
    

Intervention name(s): Food: (Q-Can Plus fermented soybean beverage)
Intervention type(s): Other
Intervention description(s): Fermented soybean beverage. Dose is 8 oz, twice daily.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Prognostic Value of Adipokine Levels of Patients With Chronic Heart Failure
Condition: Chronic Heart Failure
MeSH terms: Heart Failure
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study is to determine whether expressions of adipokines can provide
      prognostic information concerning patients with chronic heart failure.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients With Chronic Heart Failure
      
Keywords: Adipokines; Chronic Heart Failure; Prognosis
Analysis of Vital, Facial and Muscular Responses Front to Music or Message in Coma, Vegetative State or Sedated Patients
Condition: Consciousness Disorders; Communication; Intensive Care
MeSH terms: Persistent Vegetative State; Consciousness Disorders
Study type: Interventional

Summary: 
      Objectives: (1) To check music or voice message influence on vital signs, facial expressions
      or muscular tonus of coma, vegetative or sedated patients; (2) To connect the existence of
      patient's responsiveness with the Glasgow Coma Scale or with the Ramsay Sedation Scale; (3)To
      evaluate the relation between the response and the score of Glasgow Outcome Scale.
    


Intervention name(s): Music and voice message
Intervention type(s): Other
Allocation: Randomized
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Glasgow Coma Scale; Glasgow Outcome Scale; Ethics
Safety and Pharmacokinetics of a Novel Niclosamide Solution in Combination With Camostat
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Niclosamide is a well-established substance that is a promising candidate for a repurposing
      approach to treat COVID-19. Niclosamide is currently marketed as a chewing tablet for the
      treatment of intestinal worm infections. The marketed formulation is optimized for minimal
      drug substance absorption. A niclosamide solution has been developed that is expected to
      release the drug substance more readily and more reproducibly.

      Camostat is approved for oral treatment of chronic pancreatitis and reflux oesophagitis in
      Japan. Camostat has been shown to effectively block viral replication in a SARS-CoV-2 animal
      model. Since the mechanisms of actions are different, it was hypothesized that a combination
      of both substances might have an additive or even synergistic effect in the treatment of
      COVID-19 patients.

      This 3-part study is designed to investigate (1) safety and pharmacokinetics of single
      ascending doses of the new niclosamide solution after fasted and fed conditions, (2) the
      relative bioavailability of the niclosamide solution compared to the chewing tablet, and (3)
      safety and pharmacokinetics of the combination of niclosamide solution and camostat after
      multiple doses in healthy volunteers.
    


Intervention name(s): Niclosamide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Niclosamide will be applied in various dosage steps, galenic preparations and in combination with camostat; placebo to the interventional drug
Intervention MeSH terms: Niclosamide
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Part A is a randomized, double-blinded, placebo-controlled, single ascending dose (SAD) study with 3 planned cohorts.
Part B consists of two randomized, open-label, two-sequence, two-period crossover cohorts comparing the new niclosamide solution with the marketed chewing tablets.
Part C is a randomized, double-blinded, placebo-controlled multiple dose study investigating the safety and pharmacokinetics of the combination of niclosamide solution and camostat over a treatment period of 7 days.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation (CTO-TNS) in Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Safety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation
      (CTO-TNS) in Major Depressive Disorder (MDD)
    


Intervention name(s): Neurolief system
Intervention type(s): Device
Intervention description(s): Non-invasive cephalic neurostimulation device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vaginal CO2 Laser in Postmenopausal Women With Overactive Bladder Syndrome (OAB)
Condition: Overactive Bladder (OAB)
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional

Summary: 
      This study evaluates the clinical efficacy and symptom relief of vaginal fractional CO2 laser
      treatment in post-menopausal women with Overactive Bladder syndrome(OAB). Post-menopausal
      women with OAB syndrome who receive β3 adrenergic receptors (mirabegron 50mg) treatment, will
      be randomized in two groups. Half participants will receive active CO2 laser therapy, while
      the other half will receive placebo CO2 laser therapy.
    


Intervention name(s): Microablative Fractional CO2 laser
Intervention type(s): Device
Intervention description(s): 3 therapies intravaginally administered will be applied at monthly intervals
Other intervention name(s): SmartXide2 V2LR, Monalisa Touch, DEKA, Florence, Italy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Turkish Version of the AOFAS Hallux MTP-IP
Condition: Foot Deformity; Hallux Deformity; Assessment, Self; Orthopedic Disorder
MeSH terms: Musculoskeletal Diseases; Foot Deformities; Foot Deformities, Congenital; Congenital Abnormalities
Study type: Observational

Summary: 
      The American Orthopedic Foot and Ankle Society hallux metatarsophalangeal-interphalangeal
      joint scale (AOFAS Hallux MTP-IP) is originally developed in English to evaluate the pain,
      function and alignment in patients with hallux deformities. The purpose of this study is to
      translate and cross-culturally adapt the AOFAS Hallux MTP-IP scale into Turkish and
      investigate its psychometric properties.
    

Detailed description: 
      The American Orthopedic Foot and Ankle Society hallux metatarsophalangeal-interphalangeal
      joint scale (AOFAS Hallux MTP-IP) is originally developed in English to evaluate joint
      function in patients with elbow stiffness. The purpose of this study is to translate and
      cross-culturally adapt the AOFAS Hallux MTP-IP scale into Turkish and investigate its
      psychometric properties. Approximately seventy patients with hallux deformities will be
      included. For cross-cultural adaptation, two bi-lingual translators will use the
      back-translation procedure. Within a 5-to-7-day period after the first assessment, the
      participants will complete the Turkish version of AOFAS Hallux MTP-IP (AOFAS Hallux MTP-IP-T)
      to evaluate test-retest reliability. Cronbach's alpha (α) will use to assess internal
      consistency. The correlation with the Turkish version of the Manchester-Oxford Foot
      Questionnaire (MOXFQ) and Short Form-12 will be determined to check the validity.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All participants are patients who have an hallux deformity and are treated in the
        orthopedic service. The participants with hallux deformity are directed for assessment
        following a confirmation by an orthopaedist based on the physical examinations and
        diagnostic imaging.
Oral Diindolylmethane (DIM) for the Treatment of Cervical Dysplasia
Condition: Cervical Dysplasia
MeSH terms: Uterine Cervical Dysplasia
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine if the use of oral Diindolylmethante (DIM), a marketed cruciferous vegetable
      based dietary supplement (Bioresponse-DIM), is associated with the regression of cervical
      dysplasia in otherwise healthy women.
    

Detailed description: 
      To determine if the use of oral Diindolylmethane (DIM), a marketed cruciferous vegetable
      based dietary supplement (BioResponse-DIM®), is associated with the regression of cervical
      dysplasia in otherwise healthy women. Additionally, the study aims to see how the use of the
      BioResponse-DIM supplement correlates with cervical HPV colonization, and to asses the
      tolerability of daily DIM supplementation
    

Intervention name(s): di indolylmethane (DIM); Red rice bran
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): This is the agent being studies. Similar agents have been reported to have potential activity.; this will act as the active comparator. The sponsor provided this as the "placebo" arm since it is a filler component of their DIM capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized double blind intervention trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cervical dysplasia, diindolylmethane, pap smear
Tryptophan Metabolism in Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Observational

Summary: 
      Tryptophan metabolism in kidney disease will be investigated in patients with chronic kidney
      disease stages (ADOQI 3-5). Tryptophan levels and respective catabolites will be assessed
      under hemodialysis.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        tertiary care academic center, university hospital
      
Keywords: Assessment of tryptophan and tryptophan catabolites and IDO-activity in patients with chronic kidney disease
Anti-fatigue Effect of Korean Red Ginseng in Patients With Non-alcoholic Hepatitis
Condition: Fatigue
MeSH terms: Hepatitis; Fatigue
Study type: Interventional
Phase: Phase 4

Summary: 
      Background: Korea red ginseng (KRG) has anti-carcinogenic activity, anti-oxidant activity,
      and cancer related anti-fatigue.

      Methods: Seventy five patients with non-alcoholic hepatitis were prospectively randomized to
      receive 3 weeks of KRG or placebo. Liver function test, pro-inflammatory cytokines,
      adiponectin, fatigue severity scale, and antioxidant activity were check and compared.
    

Detailed description: 
      Fatigue Severity Scale

      We used to be KRUPP's fatigue severity scale. The survey has nine questions as following: (1)
      my motivation is lower, when I am fatigued (2) exercise brings on my fatigue (3) I am easily
      fatigued (4) fatigue interferes with my physical functioning (5) fatigue causes frequent
      problems for me (6) my fatigue prevents sustained physical functioning (7) fatigue interferes
      with carrying out certain duties and responsibilities (8) fatigue is among my 3 most
      disabling symptoms (9) fatigue interferes with my work, family, or social life. All subjects
      scored each question on a 7-point scale (1 = strongly disagree to 4 = neither disagree nor
      agree to 7 = strongly agree). All fatigue severity scale calculated and collected by one
      research nurse (C.W.K) in the Department of Internal Medicine.
    

Intervention name(s): KRG (Korea Red ginseng); Placebo (for KRG)
Intervention type(s): Drug; Drug
Intervention description(s): 3 weeks of KRG capsule (3,000 mg/day); Placebos with same shape and size were manufactured and at Korea Ginseng Corporation
Other intervention name(s): Korea Red ginseng capsule (3,000 mg/day); Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Fatigue; Panax ginseng; Chronic hepatitis; Non-alcoholic Fatty Liver Disease; Adiponectin
Use of Laser Interstitial Thermal Therapy in the Focal Treatment of Localized Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      This is a pilot, feasibility/exploratory study to evaluate the safety of laser interstitial
      thermal therapy (LITT) using Visualase in the focal treatment of localized prostate cancer as
      well as to gather data for the design of future studies.
    


Intervention name(s): Laser Interstitial Thermal Therapy
Intervention type(s): Device
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Men, 40 to 85 years of age, recently diagnosed with prostate cancer using the MRI fusion
        technology.
      
Keywords: focal therapy; prostate cancer treatment; laser treatment
LUMINA : Measure the Effectiveness of the Booklet Named "Comprendre Les Essais Cliniques"
Condition: Rheumatic
MeSH terms: Rheumatic Diseases
Study type: Observational

Summary: 
      Various studies have shown that many patients do not understand all the information provided
      by the study investigator and by the information sheet before entering a clinical research
      protocol. Many materials has been developped in previous research, trying to improve
      patients' understanding. Nonetheless, their effectiveness remains uncertain.

      The "LUMINA" project aims to measure the effectiveness of the booklet named "Comprendre les
      essais cliniques" with patients included or not included in clinical trials within the
      Clinical Neurosciences - Rheumatology pole of the CHU de Nice. The design of this study is
      "before/after". A questionnaire was submitted to the patients before and after reading the
      booklet. That method is used in order to show if there was a difference between the score
      obtained from the questionnaire before and after reading. This difference could reflect an
      improvement in patients' comprehension and, by extension, the effectiveness of the support
      the team developed.
    


Intervention name(s): Booklet reading
Intervention type(s): Other
Intervention description(s): Submission of the questionnaire before and after booklet reading
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants coming for a consultation or an hospitalization within the Clinical
        Neurosciences-Rheumatology pole of the CHU de Nice
A Study to Assess AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)
Condition: Eosinophilic Gastritis; Eosinophilic Duodenitis
MeSH terms: Gastroenteritis; Gastritis; Eosinophilic Esophagitis; Enteritis; Duodenitis; Eosinophilia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study to assess
      the efficacy and safety of lirentelimab (AK002), given monthly for 6 doses, in patients with
      moderately to severely active Eosinophilic Gastritis and/or Eosinophilic Duodenitis (formerly
      referred to as Eosinophilic Gastroenteritis) who have an inadequate response with, lost
      response to, or were intolerant to standard therapies
    


Intervention name(s): lirentelimab (AK002); Placebo
Intervention type(s): Drug; Other
Intervention description(s): Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Eosinophil; Eosinophilic; Eosinophilic gastrointestinal disorders; EGID; EG; EGE; Eosinophilic Gastritis; Eosinophilic Gastroenteritis; Eosinophilic Duodenitis
Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 (THS 2.2)
Condition: Smoking
Study type: Interventional

Summary: 
      The overall goal of the study is to evaluate the pharmacokinetic (PK) profile (rate and the
      amount of nicotine absorbed) following a single use of the THS 2.2, a candidate Modified Risk
      Tobacco Product, compared to the PK profiles from a single use of a cigarette (CC) and from a
      single use of nicotine gum in a Japanese population.
    


Intervention name(s): THS 2.2; CC; NRT Gum
Intervention type(s): Other; Other; Other
Intervention description(s): Single use of the Tobacco Heating System 2.2 (THS 2.2); Single use of subject's own cigarette (CC); Single administration of the nicotine replacement therapy (NRT) 2 mg gum (Nicorette® 2mg)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Smoking; Nicotine absorption; Candidate modified risk tobacco product; Cigarettes; Nicotine Replacement Therapy gum (NRT gum)
A Clinical Study to Assess Single and Repeat Doses of a New Medication (GSK933776) in Patients With Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to investigate the safety and tolerability of both single and multiple intravenous
      administration of GSK933776 in patients with Alzheimer's Disease.
    


Intervention name(s): GSK933776; Placebo to match GSK933776
Intervention type(s): Drug; Drug
Intervention description(s): Part A planned doses cohort 1 to cohort 3 0.001 mg/kg, 0.01 mg/kg and 0.1 mg/kg.
Part B planned doses cohort 4 to cohort 7 0.1 mg/kg, 1mg/kg, 3mg/kg and 10 mg/kg; Part A first 2 cohorts 5 patients per cohort 2 placebo and 3 active third cohort part A 2 placebo 6 active. Part B 8 patients per cohort 2 placebo 6 active.
Other intervention name(s): GSK933776A
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Alzheimer's Disease; First Time in Human (FTIH) Study
ABC Program in Patients With Metabolic Syndrome
Condition: Weight Reduction in Patients With Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome; Weight Loss
Study type: Observational

Summary: 
      Aims: We evaluate the efficacy of the "Active Body Control (ABC) Program" for weight
      reduction in patients with metabolic syndrome.

      Methods: The ABC program combines telemonitoring of the physical activity with a low-calorie
      diet also preferring carbohydrates with low glycemic indexes. In this 12-month, randomized,
      clinical trial 60 patients will be treated according to the ABC program and 60 control
      patients will receive standard therapy.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients with metabolic syndrome
      
Biospecimen description: 
      blood samples for parameter of lipid metabolism
A Randomised, Double Blind, Placebo Controlled, 4 Period, Incomplete Block, Crossover Study Assessing the Dose-response Curve of Fluticasone Propionate in an Antigen Challenge Chamber
Condition: Rhinitis, Allergic, Perennial; Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a single-centre, randomised, double-blind, four-period, incomplete block, crossover
      study, with 8 days repeat dosing of intranasal Fluticasone Propionate (25, 50, 100, 200ug)
      and/or placebo in the Vienna Challenge Chamber in subjects with allergic rhinitis.
    


Intervention name(s): Fluticasone propionate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Corticosteriod, with anti-inflammatory effects; Placebo comparator
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: fluticasone propionate; Vienna Challenge Chamber; glucocorticosteroids; allergic rhinitis