bioihbjkbjnl/mcl2 huggingface dataset:
The Effectiveness of a High-Protein Liquid Dietary Supplementation
Condition: Malnutrition; Nutritional Status; Hospital; Hand Strength; Body Mass Index; Nutrition Assessment
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      This study was a double-blind randomized controlled trial conducted to assess the
      effectiveness of high protein liquid dietary supplementation in malnourished hospitalized
      patients. The patients were assessed for their nutritional status based on ESPEN 2015
      criteria. Patients who experienced malnutrition will be divided into 2 groups, namely the
      control group which was given a normal protein liquid diet, while the intervention group was
      given high protein liquid diet supplementation as much as 2 bottles (200 mL) per day for 7-10
      days. Furthermore, the nutritional status of the patient was assessed.
    


Intervention name(s): a hospital formula of normal protein liquid diet supplementation; a hospital formula of high protein liquid food supplementation
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): group 1 (control group) who will get a hospital formula of normal protein liquid diet supplementation (40 grams per 1000 mL); group 2 (intervention group) will get a hospital formula of high protein liquid food supplementation (60 grams per 1000 mL) as much as 2 bottles (each bottle contains 200 mL)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: a Preliminary Study
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Malnutrition; high-protein diet; nutritional status; hospitals; hand strength; body mass index; nutrition assessment; preliminary data
Dosimetry and Safety Phase 1 Study With 68Ga-PSMA-11 Sterile Cold Kit
Condition: Prostatic Neoplasm
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Prostate cancer is the most common cancer in men. Early detection of primary diseases and
      recurrence is crucial for patient counseling and management. Conventional imaging modalities
      (CT-MRI) are limited to detect recurrence.

      Choline-based PET/CT is currently widely used as primary staging tool in prostate cancer and
      in patients with suspicious recurrent disease.

      Compared to choline-based tracers, 68Ga-PSMA ligands have been shown to have a higher
      diagnostic efficacy and to increase the detection of metastases even at low PSA levels. The
      most widely used prostate-specific membrane antigen (PSMA) ligand is PSMA-11. A supplier,
      ANMI, has developed a kit formulation of PSMA-11 which will be test in this clinical trial.
    

Detailed description: 
      Prostate cancer represents the most common cancer in men and accounts for the third most
      common cancer death in men. Up to 50% of all patients undergoing radical prostatectomy or
      radiotherapy for primary treatment of prostate cancer develop biochemical recurrence. Early
      detection of primary diseases and recurrence is crucial for patient counseling and
      management. Conventional imaging modalities such as computed tomography (CT) or magnetic
      resonance imaging (MRI) are limited because they focus on morphologic information such as
      lymph node size and tissue structure.

      Positron emission tomography/computed tomography (PET/CT) is a hybrid imaging technique
      combining functional and morphological information. Choline-based PET/CT is currently widely
      used as primary staging tool in prostate cancer and in patients with suspicious recurrent
      disease. Compared to choline-based tracers, 68Ga-PSMA ligands have been shown to have a
      higher diagnostic efficacy and to increase the detection of metastases even at low PSA
      levels. The most widely used prostate-specific membrane antigen (PSMA) ligand is PSMA-11. A
      supplier, ANMI, has developed a kit formulation of PSMA-11 which can be labeled at room
      temperature by direct incubation of the kit with the gallium-68 eluted from a 68Ge/68Ga
      generator.
    

Intervention name(s): Gallium-68 PSMA-11 prepared using PSMA-11 Sterile Cold Kit
Intervention type(s): Combination Product
Intervention description(s): The patients will receive a single injection of Gallium-68 PSMA-11 to diagnose biochemical relapse of prostate cancer after treatment.
Intervention MeSH terms: Gallium 68 PSMA-11
Intervention model: Single Group Assignment
Intervention model description: 5 patients with limited recurrent prostate cancer and 3 healthy volunteers will be enrolled in this clinical trial
Masking: None (Open Label)
Primary purpose: Diagnostic
Screening of Adolescent Mental Suffering
Condition: Depression; Adolescent; Self-report Questionnaire
MeSH terms: Depression
Study type: Interventional

Summary: 
      The primary purpose is to estimate the prevalence of depression and subsyndromal states among
      adolescents 13 to 17 years consulting to hospital emergency rooms for any reason, for they
      are another way of tracking this suffering, as they host many troubled teens at once for
      health problems and accidents sometimes iterative, reflecting their risk behaviour.

      Secondary purposes are to assess the feasibility and desirability of a post-emergency medical
      consultation for adolescents who scored high on a self-administered questionnaire, and to
      assess the impact of this approach by later monitoring.
    

Detailed description: 
      This is a multicenter longitudinal survey in three emergency centers in Ile-de-France, with 2
      periods of daily collection and comprehensive three weeks spread over one year, followed by a
      remote evaluation.

      The project is as follows:

      Phase A :

      - Evaluation of the prevalence: systematic execution of self-administered questionnaire by
      all adolescents consulting, night and day in each center.

      Phase B :

        -  For adolescents whose outcome questionnaire exceed 4, a post-emergency consultation will
           be proposed within 15 days.

        -  Telephone survey, 12 months after the passage of emergency every teenager who completed
           self-administered questionnaire and presenting himself to the post-emergency
           consultation. This survey will aim to assess the psychological status of adolescents and
           the impact of any specific treatment.
    

Intervention name(s): consultation 10 days later
Intervention type(s): Behavioral
Intervention description(s): new depression screening
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Follow-Up Studies; Adolescent; Depressive Disorder, Major/diagnosis; Attempted/prevention & control; Self-report questionnaire; emmergency department; parental perception; Emergency
Environmental and Acceptance-Based Innovations for Weight Loss Maintenance
Condition: Obesity; Overweight; Weight Loss
MeSH terms: Overweight; Body Weight; Weight Loss
Study type: Interventional

Summary: 
      The major goal of this project is to evaluate an innovative approach to obesity involving
      modification of the home environment. The project also will evaluate if home environment
      modification is more effective when supplemented with distress tolerance and related skills
      training.
    


Intervention name(s): Behavior Therapy for Weight Loss; Behavior Therapy + Environment; Acceptance-based Behavior Therapy + Environment
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Standard behavioral treatment for weight loss and weight loss maintenance.; Standard behavioral therapy with an emphasis on environmental strategies.; Behavioral therapy with acceptance-based and environmental strategies.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: obesity; overweight; weight loss
Safety and Immunogenicity Study of Adenovirus-vectored, Intranasal Pandemic Influenza Vaccine.
Condition: Influenza A Subtype H5N1 Infection
MeSH terms: Influenza, Human; Adenoviridae Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test the recombinant vaccine for safety and immunogenicity in
      healthy adults volunteers. Single dose, intranasally administered vaccine using an
      adenovirus-recombinant vector has provided a safe route for inducing protection in animals
      against pandemic influenza in preclinical studies.

      The vaccine is non-replicating, tissue culture based and designed for intranasal delivery.
    

Detailed description: 
      Objectives:

      The primary objective is to evaluate the safety of the AdhVN1203/04.H5 vaccine when
      administered intranasally in two doses with an interval of 28 days in healthy adults 19-49
      years of age.

      The secondary objective is to evaluated the immunogenicity of the AdhVN1203/04.H5 vaccine at
      three different doses (10e8, 10e9 and 10e10 viral particles) when administered intranasally
      in two doses with an interval of 28 days in healthy adults 19-49 years of age.
    

Intervention name(s): Pandemic Influenza Vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Undetermined
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; Vaccine; Pandemic; Avian influenza; Adenovirus strain 5; Vectored vaccine; Intranasal; Tissue-culture derived; Non-replicating
Efficacy Study of Transcranial Magnetic Stimulation for Treatment of Obsessive-Compulsive Disorder
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aimed at verifying whether sessions of repetitive transcranial magnetic
      stimulation over a certain brain area (the supplementary motor area) could be useful in the
      relief of Obsessive-Compulsive Disorder symptoms.
    

Detailed description: 
      Patients were randomly administered either real (n = 12) or sham (n = 10) rTMS, once a day, 5
      days a week, for 2 weeks. Randomization was performed according to a computer-generated
      schedule. Subjects and scale-rater physician were blind to treatment status of individuals.
      Only the rTMS administrator was aware of group allocations. Treatment response was assessed
      by self-and clinician-rated scales before treatment, immediately after treatment and 3 months
      thereafter, with the same examiner following a subject throughout the study. All patients
      included in the study had failed adequate pharmacological treatment for at least 2
      antiobsessional drugs. Their prescription drugs were continued without change in dosage
      regimens throughout the study.
    

Intervention name(s): Repetitive Transcranial Magnetic Stimulation (rTMS); Sham repetitive transcranial magnetic stimulation
Intervention type(s): Device; Device
Intervention description(s): rTMS was administered by means of a NEURO-MS (NEUROSOFT LTD®, Russia) with a focal 8-shaped 70 mm coil. Stimulation parameters were 1-Hz, 20-min trains (1200 pulses/day) at 100% of resting MT, once a day, 5 days a week, for 2 weeks.; The sham treatment was performed using the Neurosoft ® sham coil. A metal plate placed inside this coil prevents the magnetic field from stimulating the cortex. This coil looks and sounds like an active coil.
Other intervention name(s): Neuro-MS Transcranial Magnetic Stimulator; Neurosoft sham coil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Obsessive Compulsive Disorder; Transcranial Magnetic Stimulation; Treatment
An Evaluation of the Efficacy of HEXI-PREP by Clinell Wipes
Condition: Antimicrobial Effect
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates the antimicrobial properties of HEXI-PREP by Clinell compared to both a
      negative and a positive control product.
    

Detailed description: 
      HEXI-PREP by Clinell is a sterile single sachet wipe containing chlorhexidine gluconate and
      isopropyl alcohol. Both active ingredients are well-established ingredients commonly used for
      their disinfectant properties.

      This trial is designed to assess the superiority of HEXI-PREP by Clinell Wipe against a
      negative control, and also to demonstrate the relative efficacy of HEXI-PREP by Clinell WIpe
      against a similar commercially available product.
    

Intervention name(s): HEXI-PREP By Clinell Wipes; Chloraprep; Placebos
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Sterile single sachet wipe containing 3ml solution.; Sterile applicator containing 3ml solution.; Sterile saline (0.9% w/v) wipe, containing 3ml of solution.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Comparative Study to Evaluate the Pharmacokinetics of BAT2206 vs Stelara® in Healthy Subjects
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      It is a randomized, double-blinded, single-dose, 3-arm parallel, comparative study to
      evaluate the pharmacokinetics, safety and immunogenicity of BAT2206 Injection vs Stelara®
      (EU-licensed and US-licensed) in healthy Chinese male subjects. A total of 270 healthy male
      subjects are planned to be included and randomized at a ratio of 1:1:1 to receive single
      45mg/0.5ml BAT2206 Injection or Stelara® (EU-licensed and US-licensed).
    

Detailed description: 
      The study has a screening period of 14 days. PK blood samples will be collected from subjects
      to determine the serum concentration of Ustekinumab, thus to evaluate the similarity of the
      pharmacokinetics of the three study drugs.

      The investigator will perform safety evaluation for vital signs, physical examinations,
      injection site reaction, ECG, clinical laboratory tests and adverse events throughout the
      study. Immunogenicity evaluation (ADA, ADA titration and nAb) will also be evaluated.
    

Intervention name(s): BAT2206; Stelara(US-licensed); Stelara(EU-licensed)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 45mg/0.5 ml; single dose；prefilled syringe; subcutaneous injection; 45mg/0.5 ml; single dose；prefilled syringe; subcutaneous injection; 45mg/0.5 ml; single dose；prefilled syringe; subcutaneous injection
Other intervention name(s): Ustekinumab; Ustekinumab
Intervention MeSH terms: Ustekinumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Girls OnGuard: HPV Vaccination Uptake Among African American Adolescent Females
Condition: Vaccination
Study type: Interventional
Phase: Phase 3

Summary: 
      African American adolescent females seeking treatment for STIs are an underserved population
      at increased risk for HPV infection. While GARDASIL is an effective preventive vaccine,
      vaccination rates are low. Given the risk for HPV infection among this subgroup and the
      negative health effects associated with HPV, enhancing uptake of GARDASIL is necessary. The
      goal of this project is to promote GARDASIL vaccination through the development of a new
      multi-component, culturally-appropriate, interactive DVD.

      We propose to recruit 280 unmarried African American adolescent females, 13-18 years of age,
      from participating clinic sites in Atlanta, Georgia. While seeking clinical services,
      adolescents will be contacted and invited to participate in the proposed study. Eligible
      adolescents will be required to provide written assent/consent prior to participation.
      Adolescents who are eligible and willing to participate in the project will complete a short
      survey on a laptop computer. The survey is designed to assess adolescents' risk taking and
      preventive behaviors. After they complete the survey, adolescents will be assigned at random
      to one of two groups. In one group, adolescents will watch a short (10 min), interactive DVD
      designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to
      help them remember to return to the clinic for their second and third vaccine doses. In the
      second group, adolescents will watch an equally short (10 min) DVD on healthy lifestyles and
      behaviors. All adolescents are eligible to receive the GARDASIL vaccine at participating
      study clinics as part of their routine standard of care.

      With the help of clinic staff, participant medical records will be reviewed over a 7 month
      period to assess vaccination rates. Vaccination rates from adolescents who received the
      interactive HPV/GARDASIL awareness DVD will be compared to the group of adolescents who
      received the healthy lifestyles DVD. It is hypothesized that study participants receiving the
      interactive DVD intervention that promotes HPV awareness will have higher vaccination rates
      over time.
    


Intervention name(s): Girls OnGuard
Intervention type(s): Behavioral
Intervention description(s): Using the Information-Motivation-Behavioral Skills Model (IMB) as a framework, Girls OnGuard is an interactive,culturally-appropriate, computer-delivered program design to enhance initial uptake of GARDASIL by addressing three major components: (1) information about GARDASIL; (2) motivation to obtain GARDASIL vaccination; and (3) behavioral skills to enhance self-efficacy of obtaining GARDASIL vaccination.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: GARDASIL; HPV; Vaccination
A PET Study With ORM-12741
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the effect of ORM-12741 on receptor occupancy by
      positron emission tomography with different doses and plasma concentrations. The
      pharmacokinetic profile and safety will also be evaluated.
    


Intervention name(s): ORM-12741
Intervention type(s): Drug
Intervention description(s): Single dose as a capsule, oral administration
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Healthy volunteer study
Will Erectile Dysfunction Increase the Risk of Prostate Cancer
Condition: Erectile Dysfunction
MeSH terms: Prostatic Neoplasms; Erectile Dysfunction
Study type: Observational

Summary: 
      The rationale for investigating the hypothesis that there is an association between erectile
      dysfunction (ED) and the subsequent development of prostate cancer is based on three
      assumptions: 1) baseline ED is common in most if not all of the cross-sectional studies in
      men with prostate cancer; 2) the development of ED and prostate cancer may have certain
      shared common risk factors; and 3) the use of testosterone for the treatment of ED has been
      suspected to be associated with prostate cancer development. Controversy exists over whether
      men with ED have an increased risk of subsequent prostate cancer. Few studies have evaluated
      the risk of developing prostate cancer for men with ED. The investigators, therefore,
      conducted a population-based longitudinal study with eight years' follow-up to examine this
      association and to evaluate the magnitude of the risk.
    


Intervention name(s): Erectile dysfunction
Intervention type(s): Other
Intervention description(s): Patients with ED are considered belonging to the exposure group.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study cohort was constructed from the Taiwan National Health Insurance Research
        Dataset. From among men with no pre-existing prostate cancer, we formed an ED group of men
        ≥50 years of age and a non-ED general population comparison group of men matched 1:4 by age
        and index date of the ED group and a concurrent second comparison group of men older than
        50 with benign prostatic hypertrophy.
      
Keywords: cohort study; prostate cancer; population-based study; benign prostatic hypertrophy
Relief of Acute Bronchoconstriction/Asthma Using the Non-Invasive AlphaCore Device
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of this pilot study is to collect preliminary clinical data related to the safety
      and preliminary clinical benefits of non-invasive vagal nerve stimulation with the AlphaCore™
      device for the relief of acute bronchoconstriction due to asthma.

      Up to 30 subjects who meet all inclusion/exclusion criteria and consent to participate in the
      study may be enrolled at up to 5 investigational (study) sites. The study sites are clinic
      settings capable of treating any potential complications of bronchoconstriction, an acute
      exacerbation of asthma, and any emergencies associated with use of the investigational
      device.
    

Detailed description: 
      Subjects will be screened, consented and enrolled at the first visit. Subjects will return to
      the second visit where they are experiencing shortness of breath and will be treated with the
      alphacore. Breathing and vital signs will be measured before, during and after the
      stimulation. The study is concluded on the third visit, 7 days later.
    

Intervention name(s): AlphaCore
Intervention type(s): Device
Intervention description(s): A single 90 second stimulation to the vagus nerve on the right side of the neck
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
ENDEAVOUR: Phase 3 Multicenter Study of Revusiran (ALN-TTRSC) in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC)
Condition: Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC); Amyloidosis, Hereditary; Amyloid Neuropathies, Familial; Amyloid Neuropathies; Amyloidosis, Hereditary, Transthyretin-Related; Familial Transthyretin Cardiac Amyloidosis
MeSH terms: Amyloid Neuropathies; Amyloid Neuropathies, Familial; Cardiomyopathies; Amyloidosis, Familial; Amyloidosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to evaluate the safety and efficacy of revusiran (ALN-TTRSC) in
      patients with transthyretin (TTR) mediated Familial Amyloidotic Cardiomyopathy. Dosing has
      been discontinued; patients are being followed-up for safety.
    


Intervention name(s): Revusiran (ALN-TTRSC); Sterile Normal Saline (0.9% NaCl)
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cardiomyopathy; Heart Failure; FAC; Amyloid; Transthyretin; TTR; RNAi therapeutic