bioihbjkbjnl/mcl2 huggingface dataset:
Supervised Versus Non-supervised Exercise on Adherence and Functional Outcomes in Colorectal Patients
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Investigation into prehabilitation by increasing the supervision of exercise in patients
      undergoing colorectal resection for cancer and comparing with patients involved in a
      rehabilitation group receiving exercise after surgery.
    

Detailed description: 
      The aims of this research project are the following:

      To determine to what extent a structured multimodal prehabilitation regimen, which includes
      aerobic and resistance exercise, nutritional supplementation and psychological coping
      strategies, initiated before surgery, and continued while in hospital and after surgery,
      optimizes the recovery of functional walking capacity following colorectal resection for
      cancer.

      To understand which measures of immediate surgical recovery are sensitive to prehabilitation
      interventions and predict change in later outcome measures.
    

Intervention name(s): Prehabilitation Plus
Intervention type(s): Other
Intervention description(s): Supervised exercise program and home-based exercise program.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Efficacy and Safety Study of TPN171H Tablets in Erectile Dysfunction.
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, randomized, double blind, placebo-controlled, parallel design study to
      evaluate the efficacy and safety of TPN171H in men with erectile dysfunction.
    


Intervention name(s): TPN171H 2.5mg group; TPN171H 5mg group; TPN171H 10mg group; Placebo group
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): TPN171H 2.5mg taken orally on demand 0.5-4 hour prior to sexual intercourse; TPN171H 5mg taken orally on demand 0.5-4 hour prior to sexual intercourse; TPN171H 10mg taken orally on demand 0.5-4 hour prior to sexual intercourse; Placebo taken orally on demand 0.5-4 hour prior to sexual intercourse
Other intervention name(s): Simmerafil; Simmerafil; Simmerafil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study to Assess Safety, Tolerability and Pharmacokinetics of XC221 in Healthy Volunteers
Condition: Influenza; Acute Respiratory Infection
MeSH terms: Respiratory Tract Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      A double-blind, randomized, placebo-controlled, Phase I clinical study of the safety and
      tolerability of increasing doses of drug XC221 after single and repeated oral administration
      in healthy volunteers. The volunteers received the study drug once, and then continued daily
      intake for 5 days after a 6-day break. The primary objective of the study was to evaluate the
      safety and tolerability profile for drug XC221 after single and multiple administration based
      on the frequency and severity of adverse events and changes in vital signs, laboratory
      results, electrocardiography and results of the physical examination. The secondary objective
      of the study was to assess pharmacokinetics of active pharmaceutical substance XC221GI and
      its metabolite XC221A.
    

Detailed description: 
      One Russian center was approved for participation in this study. One center was initiated.
      Healthy volunteers were enrolled in 1 center. The study consisted of 4 periods: screening,
      single administration, multiple administration and follow-up.

      All eligible subjects were randomized into the study in appropriate cohort groups
      sequentially. Cohort 1 - XC221 or Placebo 60 mg once and then daily 5 days after a 6-day
      break; Cohort 2 - XC221 or Placebo 200 mg once and then daily during 5 days after a 6-day
      break. The decision regarding increasing of the study drug dose for a subsequent cohort was
      made by the Data Safety Monitoring Committee on the basis of preliminary safety results
      assessment. A total of 24 volunteers received XC221 (60 mg or 200 mg) and a total of 8
      volunteers received the placebo during the study participation. The follow-up period lasted
      for 4 weeks.
    

Intervention name(s): XC221 60 mg; XC221 200 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The volunteers received the study drug once, and then continued daily intake for 5 days after a 6-day break.; The volunteers received the study drug once, and then continued daily intake for 5 days after a 6-day break.; The volunteers received the study drug once, and then continued daily intake for 5 days after a 6-day break.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: The dose cohorts were included into the study subsequently based on preliminary safety results evaluation performed by the Data Safety Monitoring Committee. 2 doses of XC221/placebo (60 mg and 200 mg) were used in the study.The duration of exposure to the study drug was 6 days in each cohort: Day 1, once, at the step of single administration, and then in 6 days, daily, 1 time a day for 5 days at the step of multiple administration.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy volunteers; Phase I; PHARMENTERPRISES
COMPLliancE and qualiTy of lifE in Asthma
Condition: Asthma; Compliance, Patient; Quality of Life
MeSH terms: Asthma
Study type: Observational

Summary: 
      A multicenter, open, non-interventional, prospective, clinical observational study on
      Conformity to Therapy and Quality of Life in Asthma in patients living in Greece
    

Detailed description: 
      Dry powder devices, available since 1970, have been developed to make inhalation simpler than
      pMDIs and relieve the need for co-ordination of spraying and inhalation, which is
      particularly important for patient groups such as the elderly and children. In addition, dry
      powder devices do not contain propellant gases potentially hostile to the environment as they
      are activated by inhalation of the patient and do not cause cold sensation upon inhalation.

      Today, the combination of inhaled corticosteroid (ICS) and long-acting β2-inducer with an
      inhaler is the basic treatment for asthma6.

      The addition of long-acting β2-inducer (LABA) to a daily inhaled corticosteroid regimen1:

        -  Improves the symptoms,

        -  Reduces nightly asthma symptoms,

        -  Improves pulmonary function,

        -  Reduces the use of β2-agonists for rapid action,

        -  Reduces the number of seizures,

        -  Does not increase the risk of hospitalizations due to asthma,

        -  Achieves clinical asthma control in more patients, faster and with less ICS than would
           be required if ICS were administered alone.

      The greater effectiveness of combination therapy has led to the development of stable
      combination inhalers that both glucocorticosteroids and LABA (eg, fluticasone-salmeterol,
      budesonide-formoterol stable compounds) are concomitantly conveyed.

      Stable combinations are more user-friendly for patients, potentially increasing compliance,
      and ensure that LABA is always accompanied by glucocorticosteroid1. Of the combinations
      available, the budesonide-formoterol combination can be used both as maintenance therapy and
      symptom relief due to the rapid onset of formoterol compared to salmeterol. Both components
      of the budesonide-formoterol combination when administered are helpful in enhancing
      protection from severe seizures in patients receiving combination therapy for maintenance and
      improve the control of asthma at relatively low ICS doses.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Asthmatic adult patients
Long-term LASIK Follow up Study
Condition: Lasik Eye Surgery
Study type: Observational

Summary: 
      Laser in situ keratomileusis (LASIK) is the most common corneal refractive surgery performed
      for correction of myopia. There are very few studies that have been performed to evaluate
      long-term outcomes after LASIK.

      In this study, we will assess long-term outcomes 5 - 10 years after LASIK to assess stability
      of visual outcomes and long-term effect on corneal morphology with in vivo confocal
      microscopy. Clinical and corneal morphology outcomes will also be compared between patients
      who had flaps created with the microkeratome and femtosecond laser.
    

Detailed description: 
      Volunteers will be eligible for enrollment into the study if have had LASIK surgery for
      correction of myopia or myopic astigmatism at the Kellogg Eye Center with either the
      microkeratome or femtosecond laser for LASIK flap creation between 5 and 10 years prior.

      A complete ophthalmic examination and corneal confocal microscopy will be performed. The
      study visit will take approximately one hour.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All subjects who had LASIK surgery for correction of myopia or myopic astigmatism at the
        Kellogg Eye Center with either the microkeratome or femtosecond laser for LASIK flap
        creation between 2002 to 2005.
      
Keywords: lasik, intralase, microkeratome
Pretreatment Identification of Duloxetine Success in Neuropathic Pain Patients
Condition: Diabetes; Painful Neuropathy
MeSH terms: Neuralgia
Study type: Interventional

Summary: 
      The purpose of this study is to identify, prior to prescribing, which neuropathic pain
      patients will benefit from duloxetine more specific the investigators aims are to:

        -  Verify whether presence of chronic pain alters the pain modulation mechanisms, such as
           DNIC (diffuse noxious inhibitory control) and TS (temporal summation).

        -  Investigate whether anti-neuropathic medications such as duloxetine indeed change the
           pain modulation profile, and whether this profile change is associated with a reduction
           of clinical pain.
    

Detailed description: 
      There is no accepted practice for selecting among recommended medications for the individual
      neuropathic pain patient. Guidelines published to date provided the evidence for their
      efficacy, however, data is not available on how to choose the right medication for the right
      patient in order to avoid long 'trial and error's. We hypothesize that medications affecting
      specific process of pain modulation will be more efficacious in patients expressing
      dysfunction of that specific process. Therefore, medications that enhance descending
      inhibition such as SSNRI will be more efficacious in patients with less-efficient pain
      inhibition. The latter is assessed by the conditioned pain modulation (CPM) paradigm.
      Accordingly, the aim of this study is to examine this hypothesis in painful diabetic
      neuropathy patients, using duloxetine, an SSNRI agent assumed to augment descending pain
      inhibition by reuptake inhibition of noradrenalin and serotonin in the spinal cord dorsal
      horn synapses. We expect to find better effect of duloxetine in those patients whose pain
      inhibition capability is less efficient, as expressed by their baseline CPM. Further, we aim
      to evaluate whether pro-nocieptive pattern of pain modulation indeed reverses in response to
      treatment. This will be explored by comparing the CPM responses before and after treatment,
      and by correlating pain alleviation with the possible changes in CPM.
    

Intervention name(s): Duloxetine
Intervention type(s): Drug
Intervention description(s): First week of placebo. then, initial dose of 30 mg/d will be given for one week, in order to minimize possible side effects and drop outs, and then a fixed dose of 60 mg/d will be given for additional 4 weeks
Other intervention name(s): SSNRI
Intervention MeSH terms: Duloxetine Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Emotional Processing, Family Life, Friendship and Social Integration in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      In addition to the physical, cognitive and psychological symptoms experienced by individuals
      with Multiple Sclerosis (MS), there is new research which indicates that some individuals
      with MS have a deficit in emotional processing, specifically, facial affect recognition.
      Emotional processing is defined as "a central aspect of social cognition". Models of social
      cognition indicate that emotional processing is an essential component of interpersonal
      relationships. The failure to accurately perceive other's emotions has been shown to lead to
      difficulty in social relationships, misinterpreting other's affect, and consequently,
      inappropriate responding.

      However, even though a significant number of individuals with MS have impairments in
      emotional processing, we do not yet have an understanding of how these impairments affect the
      social functioning of individuals with MS, including the impact of these deficits on family
      structure. It is well-known that MS impacts one's social functioning including factors such
      as employment, daily living activities and interpersonal relationships. Recently a strong
      correlation was observed between reduced social participation in MS and quality of life.
      There is evidence to suggest that emotional processing deficits lie at the heart of this
      reduced social participation in persons with MS, leading to decreased social functioning and
      thus reduced quality of life. However, to date, this hypothesis has not been tested.
    


Intervention name(s): Clinical evaluation; Cognitive evaluation
Intervention type(s): Other; Other
Intervention description(s): • Clinical assessment : Expanded Disability Status Scale (EDSS), ambulation test. Medications will be recorded.; • Neuropsychological, psychological, social and social cognitive evaluation
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: social integration; cognitive impairment; emotional processing; quality of life
Smoking Cessation in NYC
Condition: Smoking Cessation
Study type: Interventional

Summary: 
      The investigators tested the feasibility of a culturally and linguistically sensitive smoking
      cessation program with combined counseling and pharmacological components for Chinese smokers
      in New York City; identified factors and techniques that enhance the administration and
      appropriateness of the intervention program; and examined the effectiveness of this program
      on quit attempts, quit rates, and overall smoking reduction.
    


Intervention name(s): individualized counselor-led MI sessions; general health education session; NRT
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Intervention consisted of four 60-min in-person sessions of AMI counseling and a packet of self help smoking cessation materials.; four in-person 60-min health education sessions and packets of general health self-help information, nutrition, exercise, and the harmful effects of tobacco.; nicotine replacement therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Comparison of the Efficacy of Clindamycin Phosphate 1% Gel Versus Once-daily Dapsone 5% Gel in the Treatment of Moderate Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      Acne vulgaris (AV) is a disease of the pilosebaceous unit that causes noninflammatory lesions
      (open and closed comedones), inflammatory lesions (papules, pustules, and nodules), and
      varying degrees of scarring. The key pathogenic processes includes alteration of follicular
      keratinization that leads to comedones; increased and altered sebum production under androgen
      control; follicular colonization by Propionibacterium acnes; . The role of topical
      antibiotics in treating acne is well established. Clindamycin is a topical antibiotic which
      has been widely used in treatment of acne for many decades. The extensive use of antibiotics
      in acne has lead to the development of resistance to antimicrobial therapy. Dapsone is known
      to have antibacterial as well as anti-inflammatory action which may help in reduction of
      acne.
    

Detailed description: 
      Topical Dapsone 5% gel contains sulfone and has an advanced solvent micro particulate
      delivery system that enables penetration of stratum corneum . It is a new topical drug used
      in the treatment of Moderate Acne Vulgaris.
    

Intervention name(s): Clindamycin and Dapsone gel for 03 months
Intervention type(s): Drug
Intervention description(s): Clindamycin is a topical antibiotic which has been widely used in treatment of acne for many decades. Topical Dapsone 5% gel contains sulfone and has an advanced solvent micro particulate delivery system that enables penetration of stratum corneum . It is a new topical drug used in the treatment of Moderate Acne Vulgaris. It has antibacterial as well as anti inflammatory effects
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Dapsone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Brain-Computer Interface (BCI) Based Intervention for Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study aims to examine the efficacy of a brain-computer interface system for the
      treatment of inattentive symptoms of Attention Deficit Hyperactivity Disorder (ADHD). The
      investigators hypothesis is that children with ADHD receiving treatment with the BCI-based
      training will improve to a greater extent than the control group.

      Additionally, the investigators are also conducting an fMRI study involving interested
      participants, to elucidate the neural mechanisms underlying any behavioural improvement. This
      is necessary to help the investigators gain a better picture of brain correlates related to
      ADHD and understand how the intervention can affect the brain.
    

Detailed description: 
      This BCI study will involve 2 phases. The first phase is a preliminary study to test the
      safety and effectiveness of the novel BCI device which involves newly developed dry electrode
      sensors and intervention game. Twenty children, aged 6-12 and diagnosed with Inattentive or
      Combined subtype of ADHD will be recruited for the study. This open-label, experimental arm
      will go through 8 weeks of BCI intervention.

      The second phase will be a randomized controlled trial involving 160 children. They will be
      randomized into the treatment or control arm. The treatment arm will receive 8 weeks of BCI
      intervention, similar to the experimental arm. The other group will serve as wait-list
      controls.

      The fMRI trial aims to examine the underlying neural processes explaining any therapeutic
      effects that may be seen.

      The study will enroll 70 children with ADHD, aged 6-12, who are participating in the main
      randomized controlled trial: 40 from the BrainpalTM intervention group and 30 from the
      control group; participants will undergo fMRI scan at Week 0 and 8 or Week 8 and 16. The
      study will recruit another 30 children aged 6-12 from the community as the healthy control
      group, who will undergo the same imaging procedure once. The scans will involve both
      functional and structural imaging.
    

Intervention name(s): BCI
Intervention type(s): Device
Intervention description(s): 24 half-hour sessions over 8 weeks, i.e. 3 sessions per week, followed by 3 once-monthly boosters.
Other intervention name(s): Brain-Computer Interface
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Brain-Computer Interface
The Efficacy of the no!no!Back for Chronic Low Back Pain
Condition: Mild to Moderate Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This pilot study is designed to evaluate the efficacy of the no!no!Back continuous passive
      motion device in relieving of mild to moderate non-specific low back pain.
    

Detailed description: 
      The no!no!Back is an electrically operated, continuous passive motion device including a
      platform that performs angular oscillations. The device is intended to be used at home as an
      accessory for relieving of mild to moderate low back pain (LBP).

      This study is designed to determine the efficacy of daily use home use with the no!no!Back
      device during 3 weeks and to assess the sustained effect 3 weeks later. Up to 30 subjects
      will be randomized to either an immediate treatment (IT) group that will receive the
      no!no!Back device at the baseline visit, or to the wait-list control (WLC) group that will
      receive the device 3 weeks later. The evaluation will include level of pain using the
      numerical rating scale (NRS), functional health status by Oswestry disability index (ODI),
      and subject satisfaction.
    

Intervention name(s): no!no!Back
Intervention type(s): Device
Intervention description(s): Self treatments daily for 3 weeks, in up to three 10-minutes sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Back Pain
Comparative Study of Turmeric Extract in Patients With Arthrosis.
Condition: Arthralgia; Stiffness of Unspecified Joint, Not Elsewhere Classified; Disturbance of Activity and Attention; Quality of Life
MeSH terms: Arthralgia; Osteoarthritis
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to test if an extract of Turmeric can alleviate symptoms of
      osteoarthritis in volunteers with osteoarthritis of the hip and or knee.
    

Detailed description: 
      The included volunteers, who are devided into two groups either placebo or turmeric extract,
      will be tested using WOMAC questionnaires focussing on pain, stiffness and daily activity. In
      addition different aspects of quality of life will be evaluated and the consumption of rescue
      medication will be recorded in patients personal diary.

      The treatment period is 3 month with the posibility to continue for an additional 3 month.
    

Intervention name(s): Placebo; Turmeric
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Placebo in gelatin capsules; Turmeric in gelatin capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Half of the volunteers are given placebo and half of the volunteers are given Turmeric extract
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Arthralgia, stiffness of joints, quality of life