bioihbjkbjnl/mcl2 huggingface dataset:
Promoting Patient Engagement in Clinical Preventive Services: Evaluating the Use of Healthfinder
Condition: Health Knowledge, Attitudes, Practice
Study type: Interventional

Summary: 
      Clinical preventive services (CPS) are fundamental to early disease detection and improvement
      of health outcomes but are often poorly understood and utilized by patients. Myhealthfinder
      is a web-based tool developed by the Office of Disease Prevention and Health Promotion
      (https://healthfinder.gov). This study tests the "prescription" of myhealthfinder to engage
      patients in CPS, improve patient-clinician communication and increase uptake of CPS.
    


Intervention name(s): Healthfinder invitation
Intervention type(s): Other
Intervention description(s): Invitation to use healthfinder (healthfinder.gov/myhealthfinder
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Local mEHT + TCM Versus Intraperitoneal Chemoinfusion in Treatment of Malignant Ascites: Phase II RCT
Condition: Peritoneal Neoplasms; Ascites; Yang Deficiency; Yin Deficiency
MeSH terms: Peritoneal Neoplasms; Ascites; Yin Deficiency; Yang Deficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial studies efficacy and safety of combination of modulated electro-hyperthermia
      (mEHT) with Traditional Chinese Medicine (TCM) in treatment of peritoneal carcinomatosis with
      malignant ascites versus standard chemoinfusion (CDDP+5FU).
    

Detailed description: 
      Conservative treatment of peritoneal carcinomatosis with malignant ascites (PCMA) is based on
      chemoinfusion with its inherent toxicity. There is a strong demand for a safe and non-toxic
      method of treatment of PCMA. The new technology of modulated electro-hyperthermia (mEHT) has
      proven efficacy in many advanced cancers with minimal side effects and synergy with
      Traditional Chinese Medicine (TCM). TCM has a long history of application at advanced cancer
      as a symptomatic treatment and enhancer of the general resistance of the organism. Shi Pi
      Decoction is supposed to be the optimum co-treatment of PCMA according to principles of TCM.
      Intraperitoneal chemoinfusion (IPCI) with cisplatin and fluorouracil is a widespread standard
      treatment of PCMA in China. This randomized II phase trial studies efficacy and safety of
      combination of mEHT with TCM in treatment of PCMA versus standard IPCI (CDDP+5FU).
    

Intervention name(s): Modulated Electro-Hyperthermia (mEHT); TCM Herbal Decoction (Shi Pi); IPCI (CDDP+5FU)
Intervention type(s): Device; Dietary Supplement; Drug
Intervention description(s): MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.; Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang.; Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm).
Other intervention name(s): Oncothermia; Shi Pi Decoction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peritoneal Carcinomatosis; Malignant Ascites; Modulated Electro-Hyperthermia; Traditional Chinese Medicine
Can a Person-centred-care Intervention Improve Health-related Quality of Life in Patients With Head and Neck Cancer
Condition: Health Related Quality of Life
Study type: Interventional

Summary: 
      At all of the follow-ups, including the worst period (between four and ten weeks), the
      intervention group reported higher scores than the control group, suggesting in this RCT that
      adopting the person-centred-care concept was a promising way to improve function and
      wellbeing in patients with HNC.
    

Detailed description: 
      Background: The incidence of head and neck cancer (HNC) is increasing slightly. HNC and its
      treatment may affect general domains of health-related quality of life (HRQoL) and provoke a
      variety of adverse symptoms and side effects, both during and after treatment. The objective
      of this study was to compare a person-centred care intervention in terms of HRQoL,
      disease-specific symptoms or problems, with traditional care as a control group for patients
      with HNC. Methods: The intervention and control groups comprised 54 and 42 patients,
      respectively. Outcome measures used were: the EORTC QLQ-C30 and the EORTC QLQ-C35. Both
      groups answered the questionnaires at baseline and after 4, 10, 18 and 52 weeks from start of
      treatment. The questionnaires' scores were compared between groups by using independent
      samples test (Student's t-test) and non-parametric test (Mann-Whitney U Test) for continuous
      variables. For categorical data, Fisher's exact test was used. Longitudinal data were
      analysed using repeated measures in covariance pattern models. Results: At baseline, the
      intervention and control groups were comparable in terms of medical and sociodemographic
      variables, clinical characteristics, HRQoL and disease-specific symptoms or problems. At all
      the follow-up points, even during the worst period for the patients, the person-centred-care
      group consistently reported higher scores than the control group. The differences were
      numerically but not always statistically significant. When using repeated measures in
      covariance pattern models, statistically significant results were found for HNC-specific
      problems, swallowing (p= 0.014), social eating (p=0.048) and feeling ill (p=0.021).
    

Intervention name(s): gPCC (Gothenburg Person Centred Care)
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Head and neck cancer; Person Centred Care; Health related quality of life; EORTC QLQ-C30; EORTC QLQ-C35
Evaluation of Safety and Efficacy of BBI-2000 in Treating and Preventing Contact Dermatitis
Condition: Contact Dermatitis
MeSH terms: Dermatitis; Dermatitis, Contact
Study type: Interventional
Phase: Phase 1

Summary: 
      This two cohort study (Cohort A and B) is being conducted to assess the safety and efficacy
      of BBI-2000 for the prevention (Cohort A) and treatment (Cohort B) of delayed type
      hypersensitivity reaction.
    

Detailed description: 
      This two cohort (Cohort A and B) single-center, randomized, controlled study is being
      conducted to evaluate the safety and efficacy of BBI-2000 for the prevention (Cohort A) and
      treatment (Cohort B) of delayed type hypersensitivity (DTH) reactions.

      Subjects in Cohort A will initially receive either pre-treatment with BBI-2000 or vehicle, on
      an area on the back. Diphencyprone (DPCP) will then be administered, via Finn chamber, to the
      same area on the back. The treated area will then be assessed to determine if BBI-2000 was
      effective in preventing a contact hypersensitivity reaction.

      Cohort B will first be sensitized with DPCP as in Cohort A. Indicated regions of the back
      will then be challenged to illicit a DTH reaction. Following the challenge, indicated regions
      on the subject's back will be treated with either (A) BBI-2000, (B) vehicle, (C) no topical
      application or (D) clobetasol propionate. The efficacy of BBI-2000 will be evaluated by
      monitoring response of the area of contact hypersensitivity reaction.
    

Intervention name(s): BBI-2000; Vehicle; Multiple treatments
Intervention type(s): Drug; Drug; Other
Intervention description(s): Experimental; Vehicle Comparator; BBI-2000, Vehicle, Clobetasol Propionate, No treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Contact; Treatment; Prevention; BBI-2000; Dermatitis; Allergic
Substrate Metabolism and Insulin Sensitivity in Acromegalic Patients Before and After Treatment
Condition: Acromegaly; Excessive Growth Hormone Secretion; Insulin Resistance
MeSH terms: Acromegaly; Insulin Resistance
Study type: Observational

Summary: 
      The purpose of this study is to investigate the effects of chronic elevated growth hormone on
      metabolism and insulin sensitivity by studying acromegalic patients before and after
      treatment.
    


Intervention name(s): Transsphenoidal adenomectomy
Intervention type(s): Procedure
Intervention description(s): Surgery
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patiens recently diagnoses with acromegaly, recruited from the clinic
      
Biospecimen description: 
      Whole blood, serum, muscle samples, fat samples
    
Keywords: Acromegaly; Growth Hormone; Insulin resistance; Glucose tolerance; Body Composition; Substrate metabolism
Subcutaneous Peripheral Nerve Stimulation (PNS) as "Hybrid Stimulation" After Failure of Spinal Cord Stimulation (SCS) to Control the Back Pain Component in Failed Back Surgery Syndrome (FBSS) Patients.(CUMPNS Study)
Condition: Failed Back Surgery Syndrome
MeSH terms: Syndrome; Failed Back Surgery Syndrome
Study type: Interventional

Summary: 
      Despite globally favourable outcomes of Spinal Cord Stimulation (SCS), a significant
      proportion of Failed Back Surgery Syndrome (FBSS) patients do not obtain adequate coverage of
      low back pain. Peripheral Nerve Stimulation (PNS) has obtained the European Conformity mark
      for the treatment of chronic refractory neuropathic pain and is now commonly used in some
      countries to target back pain. However, the potential value of combining SCS and PNS as
      "hybrid stimulation" remains poorly described with only isolated case reports or limited
      experience in various indications.

      The "CUMPNS" comparative randomized study is designed to demonstrate the potential analgesic
      efficacy of PNS in addition to previously implanted SCS, to treat the residual low back pain
      component pain in refractory FBSS patients.
    


Intervention name(s): Subcutaneous peripheral nerve stimulation; SCS Only
Intervention type(s): Device; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cantharidin-induced Skin Blister for Testing Anti-inflammatory Effects of Macrolides
Condition: Inflammation
MeSH terms: Blister; Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the utility of the cantharidin-induced skin
      blister assay for evaluation of the anti-inflammatory effects of macrolides in healthy male
      volunteers.
    

Detailed description: 
      The study will consist of 3 parts. Part A of the study will assess the feasibility of
      different cantharidin blister induction/sampling timepoints (challenge options) ranging from
      16/16 hours to 48/48 hours, including the ability to evaluate the acute and resolving phase
      of acute inflammation. In Part A, 4 to 8 healthy male volunteers will be included. This will
      be followed by Part B (in up to 12 subjects), aimed to select the optimum challenge option
      based on the reproducibility of read-outs across two challenge sessions. This option will be
      applied in Part C in up to 24 subjects in order to evaluate the utility of the assay to
      demonstrate anti-inflammatory effects of a standard macrolide (azithromycin). Part C is
      designed as a double-blind, placebo-controlled, parallel group trial. Following the first
      cantharidin challenge and blister evaluation, subjects will be randomised in a 1:1 ratio to
      receive azithromycin or placebo. Skin blister induction and assessment will be repeated
      immediately after treatment completion and, potentially, approximately 3 weeks later. The
      inflammatory response to cantharidin and its modulation by azithromycin will be evaluated by
      total and differential cell counts in blister fluid, monocyte/macrophage phenotyping and the
      measurement of selected inflammation mediators in blister fluid and serum.
    

Intervention name(s): Cantharidin; Azithromycin; Placebo
Intervention type(s): Other; Drug; Drug
Intervention description(s): Cantharone topical liquid containing 0.7% cantharidin (blistering agent) is applied as 25 µL of 0.1% cantharone solution in acetone; Zithromax (250 mg oral capsule).; Matching placebo
Intervention MeSH terms: Azithromycin; Cantharidin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Macrolides; Inflammation; Azithromycin; Cantharidin induced skin blister model
Absorption and Metabolism of Dietary Cocoa Procyanidins in Humans
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether or not the intake of dietary procyanidins
      (oligomers of flavanols) contribute to the systemic presence of flavanols in healthy humans.
    

Detailed description: 
      Flavanols and their oligomeric derivatives, the procyanidins, are plant-derived compounds
      normally present in the human diet. Accumulating data demonstrate a causal role for flavanols
      in mediating the cardiovascular benefits associated with the consumption of
      flavanol-/procyanidin-containing foods. Evidence for a direct, causal role for procyanidins
      in this context is far less profound. As this is often based on the poor absorption of
      procyanidins, it has been proposed that procyanidins may indirectly contribute to the
      systemic presence of bioactive compounds via derivatives generated from the breakdown or
      catabolism of procyanidins in the gastrointestinal tract. These postulated 'breakdown
      products' include: i) flavanols, putatively generated by acid hydrolysis in the stomach, and
      ii) series of phenolic compounds, including 5-(3,4-dihydroxyphenyl)-gamma-valerolactone, that
      are produced from procyanidin catabolism by the gut microbiome. Verification or rejection of
      these suppositions could significantly impact the interpretation of epidemiological-/dietary
      intervention data, and the design of food-content data bases. To address this question,
      healthy volunteers will consume specially designed cocoa-based dairy drinks containing
      flavanols and procyanidins (dimers to decamers) either together or individually.
    

Intervention name(s): Flavanol- and procyanidins-containing drink; Procyanidins-containing drink; Flavanol-containing drink
Intervention type(s): Other; Other; Other
Intervention description(s): Single oral intake of a cocoa-based dairy drink containing flavanols [monomer] and procyanidins [dimers to decamers]; Single oral intake of a ocoa-based dairy drink containing procyanidins [dimers to decamers]; Single oral intake of a cocoa-based dairy drink containing flavanols [monomers]
Other intervention name(s): Cocoa-based dairy drink; Cocoa-based dairy drink; cocoa-based dairy drink
Intervention MeSH terms: Proanthocyanidin; Procyanidin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: flavanols; procyanidins; absorption; cocoa polyphenols; Flavanol and procyanidin absorption in healthy volunteers
Medications for Obstructive Sleep Apnea In Children With Down Syndrome
Condition: Obstructive Sleep Apnea; Down Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Down Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double blind, cross-over study of the combination of atomoxetine and
      oxybutynin (ato-oxy) in children with DS and OSA documented by polysomnography (PSG).
      Participants will receive high dose ato-oxy for four weeks as well as low dose ato-oxy for
      four weeks in random order. During the high dose ato-oxy period, participants will take 5 mg
      oxybutynin and 0.5mg/kg/day (max 40 mg) atomoxetine nightly for one week. Atomoxetine dose
      will then be increased to 1.2 mg/kg/day (max 80 mg). During the low dose ato-oxy period,
      participants will take 5 mg oxybutynin and 0.5mg/kg/day (max 40 mg) atomoxetine. Dosing of
      the study treatment will occur approximately 30 minutes prior to bedtime. Participants who
      withdraw from the study will not be replaced.

      Study participants will undergo eligibility screening that will include an initial screening
      to determine whether non- PSG enrollment criteria are met, followed by a 1 night in-lab PSG
      and health-related quality of life assessment for participants who qualify based on non-PSG
      criteria. For participants who are eligible and enroll in the study, the screening PSG night
      will serve as the baseline measure for apnea hypopnea index (AHI) and other PSG endpoints. On
      the final night of dosing for both high dose ato-oxy and low-dose ato-oxy, participants will
      return for inpatient PSG and health-related quality of life assessment. The primary efficacy
      endpoint is the change in obstructive AHI from baseline (high dose ato-oxy vs. low dose
      ato-oxy).
    


Intervention name(s): Atomoxetine and oxybutynin (ato-oxy)
Intervention type(s): Drug
Intervention description(s): Low dose ato-oxy will include 0.5 mg/kg/day of atomoxetine (max 40 mg) in combination with 5 mg oxybutynin High dose ato-oxy will include 1.2 mg/kg/day atomoxetine (max 80 mg) and 5 mg oxybutynin
Intervention MeSH terms: Oxybutynin; Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: atomoxetine; oxybutynin
Measuring and Evaluating the Changes in Anxiety Levels of Children With Repetitive Sessions of Dental Treatments
Condition: Dental Anxiety
MeSH terms: Anxiety Disorders
Study type: Observational

Summary: 
      Dental anxiety is defined as the fear of terrible events during dental treatment and the loss
      of control.Anxiety may be related to adaptation of the patient to external factors in
      environment, so the adaptation of the pediatric patient to the stimuli in the dental
      environment may affect the level of anxiety.The aim of the this study was to evaluate the
      relationship between sequential visits in dental treatments and dental anxiety levels of
      pediatric patients with anxiety scales and physiological measurements.
    

Detailed description: 
      A total of 224 children aged 5-8 years who needed at least two restorative dental treatment
      of the mandibular first primary molar were included in the study.

      In each sessions the Wong-Baker FACES Pain Rating Scale (W-BFRS) was used to evaluate the
      dental anxiety before and after the treatment.

      The Modified Corah's Dental Anxiety Scale (MDAS) was used as a dental anxiety measurement
      method.

      A portable finger pulse oximeter (Nellcor™ PMN10, Medtronic Corp. MN, USA) was used to
      measure the heart rate.

      Data were statistically analyzed with the help of the Statistical Package for Social Sciences
      statistical software (SPSS 18.0), considering a 5% significance level. Nonparametric tests
      were used. Normality assumption was evaluated with the Kolmogorov Smirnov test. The
      association between two groups was analyzed by Wilcoxon Signed Rank Test.
    

Intervention name(s): Dental treatment
Intervention type(s): Procedure
Intervention description(s): bilateral restorative treatment on the mandibular primary first molars
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 224 children aged 5-8 years who needed at least two restorative dental
        treatments of the mandibular first primary molar were included in the study. As the
        inclusion criteria, children with no mental disorders, with no past dental experience,
        hospitalization or invasive medical treatments, and no pain or symptom in their oral
        health. All included children and parents had to spoken and understood the Turkish
        language. Patients with chronic systemic illnesses that may affect the blood pressure or
        heart rate of a child were excluded from the study. Only children who required
        multiple-visit treatments were taken into consideration.
A Study to Assess Safety, Tolerability, PK and PD of AZD2373 in Healthy Male Participants of Sub-Saharan West African Ancestry
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 study to assess the the safety, tolerability and pharmacokinetics (PK) of
      AZD2373, following subcutaneous (SC) administration of multiple ascending doses (MAD) of
      AZD2373 in healthy male participants of sub-Saharan West African ancestry.
    

Detailed description: 
      This study will be conducted as a single center, randomized, placebo-controlled, single-blind
      study to assess the effect of AZD2373 following multiple ascending dose sequential group
      design administrations to healthy male participants of sub Saharan West African ancestry.

      The study will consist of up to 5 cohorts

      Up to 40 male participants aged 18 to 55 years (inclusive), at time of informed consent, will
      be randomized. The MAD study subjects will be selected based on the results of the
      pre-screening study with regards to APOL1 allele status.

      For all cohorts, 8 participants will participate in each cohort.

      The expected duration for any participant participating in the study is approximately 14 to
      16 weeks, excluding an up to 35-day Screening Period.
    

Intervention name(s): AZD2373 subcutaneous injection; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Randomized subjects will receive multiple ascending dose of AZD2373 by SC injection (dose 1, dose 2, dose 3, dose 4, dose 5).; Randomized subjects will receive a multiple ascending dose of placebo (saline solution) by SC injection.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Phase 1; Randomized; Single-blind; Placebo controlled; AZD2373; Multiple Ascending Dose