bioihbjkbjnl/mcl2 huggingface dataset:
A Clinical Study of the HIV Drug CPT31 in Healthy Volunteers
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This first-in-human study will evaluate the safety, tolerability, immunogenicity, and
      pharmacokinetics of the HIV entry inhibitor CPT31 (cholesterol-PIE12-2-trimer) in healthy
      adults. This is a randomized, placebo-controlled, double-blind, single ascending dose study.
    

Detailed description: 
      This is a single subcutaneous (SC) dose study. Doses will be administered in an escalating
      manner following satisfactory review by a Protocol Safety Review Team (PSRT) of the safety,
      tolerability and pharmacokinetic (PK) data through Day 6 from the lower dose levels. 32
      healthy subjects will be studied in 4 groups (Groups A1 to A4).

      This study will comprise a placebo-controlled, double-blind, single-dose, sequential-group
      design in healthy subjects. Each subject will participate in 1 treatment period and reside in
      the Clinical Research Unit (CRU) from Day -1 through Day 6. It is planned for 6 subjects per
      dose level group to receive SC CPT31 and 2 subjects to receive matching placebo. Each group
      will be divided into 2 cohorts, with each cohort being dosed 72 hours apart. Sentinel dosing
      will take place in the first cohort, which will comprise 2 subjects, with 1 subject receiving
      CPT31 and 1 subject receiving placebo. The second cohort will comprise 6 subjects, with 5
      subjects receiving CPT31 and 1 subject receiving placebo. Blood samples for PK analysis and
      assessment of immunogenicity will be collected predose and up to 5 days postdose, with an
      additional immunogenicity sample taken at the Follow-up visit.
    

Intervention name(s): CPT31; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer; matching placebo
Other intervention name(s): cholesterol-PIE12-2-trimer; cholesterol-PIE12-trimer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: D-peptide HIV entry inhibitor
SB705498 Proof of Concept Chamber Challenge in Subjects With Non Allergic Rhinitis
Condition: Rhinitis
MeSH terms: Rhinitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the pharmacodynamic (PD) effects (Total Symptom Score
      (TSS) and its individual components: rhinorrhoea, nasal congestion, post-nasal drip) of
      intranasal, repeat dose SB-705498 in non-allergic rhinitis (NAR) patients elicited by a cold
      dry air challenge in an environmental exposure chamber (EEC). SB-705498 is a selective
      antagonist of the transient receptor potential vanilloid-1 (TRPV1) ligand gated ion channel.
      TRPV1 is a cation permeable ion channel that can be activated by several physiological
      factors, such as heat, protons (pH), osmotic stress, eicosanoid derivatives, anandamide, and
      by products of inflammation, such as histamine, prostaglandins and bradykinin. In the nose,
      the local TRPV1 expressing sensory C-fibres are thought to play a key role in the development
      of nasal hyper-responsiveness to environmental provocateurs. It has been proposed that
      blocking the nasal sensory nerve stimulation may control nasal hyper-responsiveness and
      therefore prevent the induction of rhinitis symptoms. In this context, preclinical evidence
      supports that targeting TRPV1 by SB-705498 may be an attractive option.

      In this study NAR patients will be randomised, in a double blind, placebo controlled cross
      over design to receive 14 day repeat doses of 12mg intra-nasal SB-705498 once daily. Whilst
      dosing at home, subjects will record symptom scores to document their symptoms. In addition,
      during visits to the clinical unit, acoustic rhinometry, quality of life questionnaires and
      safety assessments will be monitored.
    


Intervention name(s): SB-705498; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 12mg intra nasal; Placebo intra nasal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of the Practice of Three Morning Sputa on Separate Days for Diagnosis of Mtb
Condition: Pulmonary TB
MeSH terms: Tuberculosis, Pulmonary
Study type: Observational

Summary: 
      Obtain sputum smears within one day to rule out TB
    


Intervention name(s): Obtain standard three daily sputum samples vs. three samples on the first day for the diagnosis of pulmonary TB.
Intervention type(s): Procedure
Intervention description(s): Sputum induction
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        TB patients
Validation of a Novel Robot-aided Assessment of Gait Ability
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      The aim of this study is the validation of a novel gait assessment method implemented in the
      Lokomat gait trainer with respect to established clinical gait assessment methods. The
      walking assessment method is based on the progressive reduction of the support of the device.
      The outcome measures of this algorithm will be the support needed in the different gait
      phases (guidance force of hip and knee joints) and the support required to the body weight
      support system (unloading). The hypothesis is that the guidance force and the support of the
      device will converge to a profile individual for each subject that is representative of one's
      impairment in the different gait phases. The reliability of the method will be tested
      collecting data from two sessions of Lokomat training. The validity of the method will be
      tested comparing the outcome of the assessment task with established clinical walking
      assessment measures.
    


Intervention name(s): Lokomat gait trainer
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Spinal Cord Injury; adaptive control; assessment; assist-as-needed; walking ability; Lokomat
The Dose-response "Pilot" Study of Topically Delivered Clobetasol Propionate Lotion in Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the dose-response relationship for Clobex TM (clobetasol propionate) Lotion,
      0.05%. This information will be used to estimate the ED50, D1, D2 parameters for use in a
      full bioequivalence study.
    

Detailed description: 
      Study Type: Interventional Study Design: Randomized, open label, one period, dose response,
      vasoconstrictor assay study.

      Official Title: Dose Response of Clobex 0.05% Lotion

      Further study details as provided by Actavis Elizabeth LLC:

      Primary Outcome Measures:

      · Vasoconstrictor Response
    

Intervention name(s): Clobex TM (Clobetasol) 0.05% Lotion, single exposure
Intervention type(s): Drug
Intervention description(s): Subjects received Galderma Laboratories, L.P. formulated products
Other intervention name(s): Clobetasol
Intervention MeSH terms: Clobetasol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Vasoconstriction; Clobetasol; Healthy adult females
Ethnic Variations in Antidepressant Response
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 4

Summary: 
      This 11-week study aims to determine how genetic factors affect the way African Americans and
      Caucasians with major depression respond to antidepressant medication [citalopram (Celexa®)].
    

Detailed description: 
      Depressed patients vary substantially in their responses to antidepressants. Genetic factors
      may account for a large part of these differences in response. This study will include both
      African Americans and Caucasians to examine the role of genetic factors in treatment
      response.

      Participants receive citalopram (Celexa) for 8 weeks and a placebo for 1 week. Visits occur
      once a week for 11 weeks. A variety of interviews, scales, tests, and questionnaires are used
      to assess participants.
    

Intervention name(s): Citalopram
Intervention type(s): Drug
Intervention description(s): PDA Approved antidepressant
Intervention MeSH terms: Citalopram
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depressive Disorder
N.I.S of AIT in Adult Patients With House Dust Mite Allergy in Real Practice in France
Condition: Allergic Rhinitis Due to House Dust Mite; Allergic Asthma Due to Dermatophagoides Farinae; Allergic Asthma Due to Dermatophagoides Pteronyssinus
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic; Dust Mite Allergy; Hypersensitivity
Study type: Observational

Summary: 
      Non-interventional study to investigate the safety and tolerability of allergy immunotherapy
      ACARIZAX® 12 SQ-HDM in real-life clinical practice in adults patients (>18 years) with house
      dust mite allergy over a period of 12 months.
    

Detailed description: 
      Condition:

        -  persistent moderate to severe HDM allergic rhinitis despite use of symptom-relieving
           medication

        -  HDM allergic asthma not well controlled by inhaled corticosteroids and associated with
           mild to severe HDM allergic rhinitis. Patients' asthma status should be carefully
           evaluated before the initiation of treatment.
    

Intervention name(s): Tablet, Dispersible
Intervention type(s): Drug
Intervention description(s): 1 tablet/day with 12 SQ-HDM per lyo-tablet
Other intervention name(s): ACARIZAX 12 SQ-HDM; Standardised allergen extract from house dust mite
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults suffering of HDM allergic rhinitis or HDM allergic asthma not well controlled by
        inhaled corticosteroids and associated with mild to severe HDM allergic rhinitis.

        Patients are only included in the study after the decision for treatment with ACARIZAX® has
        already been made, and only with the objective of documenting data that reflects the
        treatment and its safety under 'real life' conditions. Accordingly, only examinations and
        inquiries conforming to routine practice are conducted and documented.
      
Keywords: Allergy; Allergic Rhinitis; Allergic Asthma; House Dust Mite; Immunotherapy
Exposure Therapy for Veterans With PTSD and Panic Attacks (Phase 1)
Condition: PTSD; Panic Attacks
MeSH terms: Panic Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the feasibility, acceptability and effectiveness of Multiple Channel Exposure
      Therapy-Veterans (MCET-V) as a treatment for returning service members with comorbid
      posttraumatic stress disorder (PTSD) and panic disorder (PD) in two phases. The first phase
      of the study will examine the feasibility and acceptability of MCET-V.
    

Detailed description: 
      With the increasing number of Operations Iraqi Freedom and Enduring Freedom (OIF/OEF)
      veterans returning from war-zone areas, many will experience anxiety disorders such as PTSD
      and comorbid problems. Currently, about one in every six OIF/OEF veterans experiences PTSD
      and co-occurring PD. Although effective treatments exist for treating one or the other, we do
      not yet have treatments that can simultaneously target PTSD and PD. Thus, recent attention
      has focused on the development of multi-component treatments that simultaneously address PTSD
      and PD. This study is the first systematic investigation of a time-limited, multi-component
      cognitive-behavioral treatment for veterans with specific comorbid anxiety problems. The
      purpose of the first phase of the study is to evaluate the feasibility and acceptability of
      the multi-component cognitive-behavioral treatment in an open trial.
    

Intervention name(s): Multiple Channel Exposure Therapy- Veterans
Intervention type(s): Behavioral
Intervention description(s): Individual therapy design completed over a 12-week period. The treatment will include psychoeducation about panic attacks and trauma and behavioral and cognitive exposure exercises.
Other intervention name(s): MCET-V
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Influence of Tumor Associated Immunity on the Number of Lymph Node Retrieved After Colorectal Cancer Surgery (Preliminary Study)
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      Hypothesis of this study is that increased immunity of primary tumor affects the increased
      number of lymph node retrieved. This study investigates whether immunity-related cytokine
      expression on primary tumor, colonic mucosa, and serum is associated with the number of lymph
      node retrieved in colorectal cancer patients.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Colorectal cancer patients diagnosed with clinically TNM I, II, or III stage
      
Biospecimen description: 
      Serum and postoperative specimen
Interest of the Dermabrasion by Laser Erbium in the Treatment of the Vitiligo
Condition: Vitiligo
MeSH terms: Vitiligo
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The treatment of vitiligo remains disappointing especially in some localization such as bony
      prominences and extremities. The association of UVB and topical steroids has been proven to
      be synergistic but the results are still insufficient in those difficult to treat areas.
      Promising results have been shown with the combination of laser assisted dermabrasion,
      topical 5FU and UVB. The investigators hypothesize that the dermabrasion of vitiligo skin
      followed by topical steroids should potentialized the effect of UVB and be superior to
      topical steroids and UVB without dermabrasion.

      The main objective of this study is to evaluate the usefulness of laser assisted dermabrasion
      combined to topical steroids and UVB phototherapy in difficult to treat areas.

      Patients with symmetrical non segmental vitiligo will be included in this prospective
      randomized monocentrer study. The investigators calculated the number of patients needed at
      25. The side that will receive the dermabrasion will be centrally randomized and the opposite
      side will serve as control. Then on both side class 3 topical steroids will be applied daily
      3 weeks on 4 for 12 weeks. UVB phototherapy will be performed twice weekly also for 12 weeks.

      The evaluation will be performed by two independent physician blinded to the treatment of
      standardized photos before and 1 month after the end of the treatment. The criteria of
      success will be at least 75% of repigmentation.
    


Intervention name(s): Group Laser = Arm A; Bras B : The group control
Intervention type(s): Device; Drug
Intervention description(s): Opposite side lesions that will receive only the treatment by topical steroids and UVB phototherapy; patient to accept habitual treatment of corticoid Opposite side lesions that will receive only the treatment by topical steroids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
An Interventional Study to Compare the Efficacy and Tolerability With Targin® in Non-malignant Chronic Pain (GLORY)
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Objectives:

        1. Objective of main interest

           - To assess the drop-out rate caused by adverse event* after 6 weeks treatment

        2. Further objectives

             -  To assess the drop-out rate caused by adverse event* after 1 week treatment

             -  To assess the pain reduction rate after 6 weeks treatment from baseline

             -  To assess the Euroquol (EQ-5D) quality of life

             -  To assess physician's overall satisfaction

             -  To assess subject's overall satisfaction

             -  To assess safety
    

Detailed description: 
      Study Design (Methodology):

      This will be a single center, open-label, randomised, phase IV, exploratory interventional
      study to compare the efficacy and tolerability of current titration patterns and slow
      titration pattern with Targin® (Oxycodone/Naloxone) in the treatment of moderate to severe
      non-malignant chronic pain patients who are dissatisfied with their current analgesic
      medication World Health Organisation (WHO) step II analgesics).

      Upon providing written informed consent, subject will be screened in the study and assessment
      will be performed at that time such as safety laboratory assessments, physical examination,
      vital sign, medical history taking, 24 hours pain intensity score. If the patient is eligible
      in inclusion/exclusion criteria at the time of visit 1, the patient will be randomized in a
      1:1 ratio to allocate in Group A or Group B. Re-screening, study drug dose interruption is
      not allowed.
    

Intervention name(s): Oxycodone/naloxone
Intervention type(s): Drug
Intervention description(s): Oxycodone/naloxone titration
Other intervention name(s): Targin
Intervention MeSH terms: Oxycodone; Naloxone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: moderate to severe non-malignant chronic pain
Cognitive Support Program for Patients With Brain Metastases
Condition: Metastases, CNS
MeSH terms: Neoplasm Metastasis; Brain Neoplasms
Study type: Interventional

Summary: 
      This study evaluates the feasibility and preliminary efficacy of a brief
      cognitive-behavioural program designed to improve cognitive functioning in people with brain
      metastases.
    

Detailed description: 
      Cognitive impairments (such as problems with attention, executive functions, memory and
      language abilities) are common in people with brain metastases as a result of disease and/or
      treatment effects. These impairments can significantly limit functional independence,
      participation in valued roles and activities, and overall quality of life.

      Building on research in other cognitively-impaired populations, we designed a brief,
      structured, patient-centered Cognitive Support Program (CSP) for brain metastases patients,
      who have the option of participating with a caregiver. Program contents include supportive
      psychoeducation, mindfulness practice, and strategy training (e.g., strategies to improve
      memory or concentration). This prospective, single-arm study will enroll 24 brain metastases
      patients to evaluate the feasibility and preliminary efficacy of the CSP. A battery of
      outcome measures is administered (1) prior to intervention, (2) after completing the CSP, and
      (3) after an additional 3 months to evaluate longer-term outcomes. Feasibility assessment
      will include program retention and adherence. Reliable change analyses will examine treatment
      effects, with regression analyses to explore moderating effects of select patient, disease
      and treatment factors (e.g., severity of baseline cognitive impairment, number of brain
      lesions, cranial radiation dose and distribution). Results of this trial will inform further
      development and implementation of evidence-based supportive care for cognitively-impaired
      brain metastases patients.
    

Intervention name(s): Cognitive Support Program
Intervention type(s): Behavioral
Intervention description(s): Three individual sessions of supportive psychoeducation, mindfulness practice, and strategy training (e.g., strategies to improve memory or concentration), with practice applying program content between sessions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Effect of Different Protein Diets on Glucose and Insulin Metabolism and Substrate Partitioning
Condition: Insulin; Glucose Metabolism
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether different protein diets affects glucose and
      insulin metabolism and substrate partitioning.
    


Intervention name(s): Control; High dairy protein; vegetable protein; High GI
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Diet consists of 15 En% dairy protein and low GI, 55 En% carbohydrates and 30 En% fat; Diet consists of 25 En% dairy protein and low GI, 55 En% carbohydrates and 30 En% fat; Diet consists of 15 En% vegetable protein and low GI, 55 En% carbohydrates and 30 En% fat; Diet consists of 15 En% dairy protein and high GI, 55 En% carbohydrates and 30 En% fat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: milk protein; overweight; insulin metabolism; substrate partitioning