bioihbjkbjnl/mcl2 huggingface dataset:
Outcomes From a Mobile Smoking Cessation Program During a Monitoring Period of 6 Months
Condition: Smoking Cessation
Study type: Interventional

Summary: 
      Prospective, open label, single center clinical study enrolling 260 subjects in a mobile
      smoking cessation program using a smartphone app and a handheld breath sensor with coaching
      support over a six month period.
    

Detailed description: 
      This is a prospective, open label, single center clinical study enrolling 260 subjects in a
      mobile smoking cessation program using a smartphone app and handheld breath sensor with
      coaching support over a six month period. Measurements include user engagement and retention
      in the program, attitude towards smoking and smoking behavior, quit rates, relapse rates, and
      quality of life over the study period, as well as user feedback on the program.

      Potential participants will complete an online screening form. Eligible participants will be
      called to confirm eligibility, discuss the study, and have their questions about the study
      answered. Interested eligible participants will then be emailed the registration link, which
      includes the electronic informed consent. After providing electronic informed consent,
      subjects register online and receive the hand held device which measures carbon monoxide (CO)
      which correlates to smoking behavior.

      Baseline questionnaires (demographics, smoking history, and attitude towards smoking) are
      completed, and subjects then self-train to use the breath sensor and smartphone app and
      allows viewing of CO sample values. The app also provides the user with ability to log
      cigarettes, view cigarette consumption trends, view instructional videos, complete
      educational activities and challenges, and engage with a coach.

      Participants will experience the program in 5 phases and then complete the study at
      approximately six months after enrolling,activating device and app.
    

Intervention name(s): Mobile smoking cessation program and CO breath sensor device
Intervention type(s): Device
Intervention description(s): Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.
Intervention model: Single Group Assignment
Intervention model description: All subjects experience same program
Masking: None (Open Label)
Primary purpose: Other
Study of the Fixation of Various Vectors in PET/CT in Patients With a With Lung Cancer Before and During of CRT or RT
Condition: Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung; Bronchial Neoplasms
Study type: Observational

Summary: 
      Study of the modification of the fixation(binding) of Fluoro-2-deoxy-D-glucose (FDG),
      fluoro-misonidazole (FMISO) and 3'deoxy-3-fluoro-thymidine deoxy-3-fluoro-thymidine (FLT)
      measured in tomography by broadcast(emission,issue) of positrons (PET) at patients before and
      in the course of exclusive radiotherapy or concomitant radiochemotherapy for primitive
      bronchial cancer.

      This protocle allows to study the simultaneous variations of the metabolism, the hypoxie and
      the cellular proliferation by PET SCAN at 5 patients reached(affected) by a primitive
      bronchial cancer in the course of exclusive radiotherapy for primitive bronchial cancer not
      small cell lung.

      The investigators are also going to study several scenarii of optimization of the
      radiotherapy according to the variations of the tumoral metabolism, the hypoxie and the
      cellular proliferation measured in the course of radiotherapy (theoretical study on console
      using the scanner and the various examinations).
    


Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Diagnosed patients with non-small-cell lung carcinoma
      
Keywords: Positron-Emission Tomography; PET Scan; FDG; FLT; FMISO; Non-Small-Cell Lung Carcinoma; chemo-Radiation Oncology; SUV
Locomotor Training in Persons With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Locomotor training is a new exercise modality that emphasizes task specificity to promote
      learning and neural plasticity. It has been reported to improve walking in patients with
      stroke, spinal cord injury and cerebral palsy. In this study, 40 patients with impaired
      ambulation due to Multiple Sclerosis will be randomized to receive 36 sessions of either
      locomotor training or an standard resistive exercise intervention.The locomotor training will
      be accomplished via a robotic device, the Lokomat, which will move the patient's legs on a
      treadmill while they are suspended in a harness.
    

Detailed description: 
      In this study, subjects with confirmed diagnosis of Multiple Sclerosis were randomized into
      one of two treatment arms. Subjects in the Lokomat arm trained on the Lokomat with a
      supervising physical therapist for 20-30 minutes/session 3 times/week. The Lokomat is a
      robotic exoskeleton which enables the subject to step on a moving treadmill. Subjects were
      suspended in a harness while in the Lokomat with full to partial body weight support as
      needed. After the training in the Lokomat, they practiced overground walking for 10 minutes.

      The other treatment arm had subjects engage in resistance training with weights and
      resistance elastic bands matched to the Lokomat group for intensity, duration and frequency.
      they did not practice overground walking.

      Primary outcome measure was speed to accomplish 25' timed walk.
    

Intervention name(s): Lokomat; resistive training
Intervention type(s): Device; Procedure
Intervention description(s): locomotor training using body weight support on a treadmill; resistive training using theraband and/or weights
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: impaired ambulation
Menopur Mixed Protocol
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study was to compare the fertilization rate between the combination of
      Menopur and Bravelle mixed in the same syringe and Menopur alone, both administered
      subcutaneously (SC), in subjects undergoing Assisted Reproductive Technology (ART).
      Additionally the study assessed subjects' ability to mix and store the combination of Menopur
      and Bravelle and to assess safety of the Menopur and Bravelle combination.
    


Intervention name(s): Bravelle; Menopur
Intervention type(s): Drug; Drug
Other intervention name(s): Bravelle®; Urofollitropin; purified form of follicle-stimulating hormone (FSH); Menopur®; Menotropin; HP-hMG; highly purified menotrophin
Intervention MeSH terms: Menotropins; Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Assisted Reproductive Technology
A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) and HIV-1 SF-2 rgp120 in HIV-1 Uninfected Adult Volunteers
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and immunogenicity of high-titered ALVAC-HIV MN120TMG (vCP205) given
      sequentially or simultaneously with rgp120/HIV-1SF2 in MF59 adjuvant emulsion in HIV-negative
      volunteers.

      ALVAC-HIV vCP205 is a second-generation candidate vaccine that can be used to induce a
      humoral and cellular response against several antigens. vCP205 expresses proteins from two
      strains of HIV (MN and LAI). rgp120/HIV-1SF2 expresses proteins from a different strain of
      HIV. This study will help to show how the immune system responds to proteins from more than
      one strain of virus.
    

Detailed description: 
      ALVAC-HIV vCP205 is a second-generation candidate vaccine that can be used to induce a
      humoral and cellular response against several antigens. vCP205 expresses proteins from two
      strains of HIV (MN and LAI). rgp120/HIV-1SF2 expresses proteins from a different strain of
      HIV. This study will help to show how the immune system responds to proteins from more than
      one strain of virus.

      Six groups of 25 volunteers each are randomized to receive simultaneous or sequential doses
      of ALVAC-HIV vCP205 and SF2 rgp120 or control vaccines (ALVAC-RG rabies glycoprotein vCP65 or
      BIOCINE Placebo Vaccine 2). In each group, 21 volunteers receive vaccine and 4 receive
      control vaccines. Volunteers are stratified by lower or higher risk sexual behavior.
      Immunizations are given to three groups at months 0, 1, 3, 6, 9, and 12, and to the other
      three groups at months 0, 1, 6, 9, and 12. Volunteers are followed for 24 months.
    

Intervention name(s): ALVAC-HIV MN120TMG (vCP205); ALVAC-RG Rabies Glycoprotein (vCP65); rgp120/HIV-1 SF-2
Intervention type(s): Biological; Biological; Biological
Intervention MeSH terms: polysaccharide-K
Masking: Double
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; HIV Envelope Protein gp120; AIDS Vaccines; HIV Seronegativity; Avipoxvirus; HIV Preventive Vaccine
Fractionated 1927nm Laser for Diffuse Pigmentation and Actinic Changes.
Condition: Skin Pigment
MeSH terms: Pigmentation Disorders
Study type: Interventional

Summary: 
      This is a single-site, non-randomized, non-controlled study at UT Southwestern Medical Center
      at Dallas in the Department of Plastic Surgery designed to follow up to 30 qualified and
      consenting subjects receiving a fractionated 1927 combination treatments for diffuse
      hyperpigmentation and/or melasma. Patients will receive treatment using f1927 devices and
      will be treated twice over the affected areas, once each month for a total of two months,
      followed by two follow-up visits at 1-month and 3-months post-treatment.
    

Detailed description: 
      This is a prospective, non-controlled study where subjects will receive treatment using f1927
      devices and will be treated twice over the affected areas of the face once each month for a
      total of two months. Patients will be evaluated at 1-month and 3-months post-treatment to
      monitor the clinical effects of treatment. Overall assessment of treatment efficacy will be
      based on evaluation of standard and close-up photography using pre- and post-procedural
      photos as well as images obtained by the Vectra H2 3D Imaging System. Baseline changes in the
      visualization and numeric analysis of pigmented areas will be evaluated utilizing the 3D
      Facial Skin Analysis software on the H2 System. Subjects will also undergo non-invasive skin
      measurements using optical coherence tomography (OCT) to noninvasively gather topographical
      and histological images of pre- and post-treated skin. Screening, treatment(s) with f1927,
      and OCT measurements are all for research purposes.
    

Intervention name(s): MOXI
Intervention type(s): Device
Intervention description(s): Patients will receive treatment using f1927 devices and will be treated twice over the affected areas, once each month for a total of two months.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Alkaline Citrate Treatment to Lower the Risk of Nephrocalcinosis in Preterm Infants
Condition: Nephrocalcinosis
MeSH terms: Nephrocalcinosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Preterm infants are at risk to develop nephrocalcinosis. Incidence numbers vary according to
      birth weight and gestation age. Very low birth weight infants have the highest risk index,
      with ~ 7-10 % of preterm infants developing nephrocalcinosis in the patient population. We,
      the researchers at the University of Cologne, and others found significantly decreased
      urinary citrate excretion (hypocitraturia) to be one of the main risk factors. Hence, we
      hypothesized, that prophylactic treatment with oral alkaline citrate solution (Shol's
      solution) would help to 1) increase urinary citrate excretion and 2) help to decrease the
      incidence of nephrocalcinosis.
    


Intervention name(s): Alkaline citrate
Intervention type(s): Drug
Intervention description(s): Prophylactic alkaline citrate medication during the first 8 weeks of life versus placebo solution to prevent nephrocalcinosis of prematurity.
Other intervention name(s): no brand names, Shol's solution versus placebo solution (NaCl 0.9 %)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: nephrocalcinosis; premature infants; hypocitraturia; alcaline citrate therapy; Nephrocalcinosis in premature infants
Comparative Bioavailability of Two Fixed Dose Combination (FDC) Formulations of Dutasteride and Tamsulosin Hydrochloride Relative to Co-administration of Dutasteride With Tamsulosin Hydrochloride in Healthy Male Subjects Under Fed and Fasted States
Condition: Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be an open-label, randomized, single dose, three way crossover study in
      healthy male subjects. The aim of the study is to evaluate the pharmacokinetic parameters of
      two formulations of a fixed dose combination (FDC) capsule of dutasteride and tamsulosin
      hydrochloride (HCl) (0.5 milligram [mg]/0.2 mg) relative to co-administration of dutasteride
      0.5 mg capsules and tamsulosin hydrochloride 0.2 mg tablets in both the fed and fasted
      states. Approximately 84 healthy adult male subjects will be enrolled into the study and
      split into two cohorts (fed and fasted), allowing for approximately 36 subjects to complete
      each cohort. Subjects from both cohorts will receive single oral doses in 3 treatment periods
      and be randomized to one of six different treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA)
      wherein A= FDC1: Dutasteride and tamsulosin HCl (0.5 mg/0.2 mg), B= FDC2: Dutasteride and
      tamsulosin HCl (0.5 mg/0.2 mg), C= Co-administration of commercial formulations of
      dutasteride(0.5mg) and tamsulosin HCl (0.2mg). Each treatment period will be separated by a
      minimum 28 day washout period. Blood samples for pharmacokinetic analysis will be taken at
      regular intervals after dosing. Safety will be assessed by measurement of blood pressure,
      heart rate and review of adverse events.
    


Intervention name(s): Treatment sequence A; Treatment sequence B; Treatment sequence C
Intervention type(s): Drug; Drug; Drug
Intervention description(s): FDC 1 - Fixed dose combination capsule of dutasteride and tamsulosin hydrochloride (0.5 mg/0.2 mg). Each capsule will contain dutasteride (0.5 mg) (CJ) and tamsulosin pellets (0.2 mg) version 1.; FDC 2 - Fixed dose combination capsule of dutasteride and tamsulosin hydrochloride (0.5 mg/0.2 mg). Each capsule will contain dutasteride (0.5 mg) (CL) and tamsulosin pellets (0.2 mg) version 2.; Co-administration of dutasteride 0.5 mg capsule (Oblong, size 6, dull yellow capsules: Commercially available) and tamsulosin hydrochloride 0.2 mg tablet (White, round standard convex tablet: Commercially available).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: bioavailability; crossover design; healthy male volunteers; tamsulosin hydrochloride; Dutasteride
Rheos® Pivotal Trial
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The purpose of this clinical trial is to demonstrate the efficacy and safety of the Rheos
      system in subjects with hypertension that are resistant to treatment with at least three
      anti-hypertension agents, one of which is a diuretic.
    


Intervention name(s): Rheos® Baroreflex Hypertension System
Intervention type(s): Device
Intervention description(s): Electrical activation of the Carotid Baroreflex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypertension; High Blood Pressure; Blood Pressure; Cardiovascular Disease; Resistant Hypertension; Stage 2 Hypertension; Hypertension that is resistant to treatment
Position-Induced Opening of the Intervertebral Foramen is Efficient to Treat an Acute Lumbosacral Radiculopathy Caused by Disc Herniation
Condition: Radiculopathy Lumbar; Disk Herniated Lumbar; Low Back Pain
MeSH terms: Intervertebral Disc Displacement; Radiculopathy; Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Efficiency of the conservative mechanical lumbosacral nerve root decompression, as an adjunct
      to pharmacological treatment, in the case of acute lumbosacral radiculopathy.
    

Detailed description: 
      Non-invasive Position-Induced Opening of the Intervertebral Foramen in sidelying position, as
      an adjunct to pharmacological treatment, was used in the case of acute lumbosacral
      radiculopathy.

      20 examinees were split into two groups, 10 in the experimental and 10 in the control group.
      Experimental group was given positional opening of the intervert. foramen, together with
      pharmacological treatment - steroid antiinflammatory drug - dexamethasone, nonsteroid
      antiinflammatory drugs and pain killers while control group was given just the same
      pharmacological treatment and recommended rest.

      Measured dependent variables were:

        1. Visual analogue pain scale (VAS) for the low back and radiculopathy, separately

        2. Straight leg raise in supine position - nerve mobility test

        3. EuroQol questionnaire - general health condition questionnaire

        4. Oswestry questionnaire - activities of daily living (ADL) specific questionnaire for low
           back pain and lumbosacral radiculopathies Inclusive criteria were: Age between 20 - 60,
           lumbar disc herniation recognized by the MRI, lumbosacral radiculopathy with symptoms
           such as radicular pain, sensation dysfunctions or motor dysfunctions, recognized by
           electromyography (EMG) diagnostics.

      Exclusive criteria: age more than 60, degenerative lumbar stenosis, spondylolisthesis,
      vertebra fractures, tumours.

      Conclusion: Physiotherapy with a positional, mechanical decompression of the compressed
      lumbosacral nerve root, as an adjunct to pharmacological treatment, is proved to be efficient
      with the lumbosacral radiculopathy. It is recommended to be applied since the first day of a
      patient admittance in the hospital if there is a position that can reduce the pain.
    

Intervention name(s): Physiotherapeutic, non-invasive position-induced opening of the intervertebral foramen
Intervention type(s): Procedure
Intervention description(s): Opening of the mechanical interface of the nerve root, neurodynamics
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Experimental group and a control group. Prospective, randomised, clinical study.
Masking: Single (Participant)
Primary purpose: Treatment
Clinical Trial on Individual Characteristics Affecting Pain Drug Therapy in Neonates
Condition: Critical Illness
MeSH terms: Critical Illness
Study type: Interventional
Phase: Phase 4

Summary: 
      Children differ from adults with respect to growth and development but also immaturity of
      various pharmacological mechanisms. Dosing schemes in children are usually derived in an
      empirical manner from clinical trials in adult patient groups. All this poses neonates to an
      increased risk for therapeutic failure and adverse drug reactions.

      Medicinal products studied during this project are among the ones with the highest needs for
      research in the pediatric intensive care. This project focuses on the necessity to integrate
      subject's individual characteristics to assist clinical decision-making in drug therapy. The
      investigators explore the mechanisms defining the dose response in pediatric populations. The
      results obtained with these studies will help to find safer drug dosing regimens in this
      delicate patient population.
    


Intervention name(s): propofol; oxycodone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Oxycodone; Propofol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neonatal intensive care; need for intratracheal intubation
Effect of an Acute Bout of Exercise on Smoking Topography
Condition: Cancer
Study type: Interventional

Summary: 
      Smokers will complete questionnaires and smoking behaviour will be examined. After abstaining
      from smoking for approximately 18 hours, they will be randomized to a moderate intensity
      exercise group or passive sitting group. Smoking behaviour (time to first puff) will be
      assessed following treatment.
    

Detailed description: 
      Lung cancer is the leading cause of cancer death in Canadians (Canadian Cancer Society, in
      which cigarette smoking is responsible for 85% of these cases. Smoking topography, a key
      facet of smoking behaviour, can be subjectively or objectively measured by quantifying puff
      volume, maximum puff velocity, interpuff interval, puff duration, number of puffs per
      cigarette, and the time to smoke a single cigarette. Smoking topography can estimate exposure
      to carcinogenic toxins present in cigarette smoking (Djordjevic, Hoffman, & Hoffman, 1997).
      Evidence exists to support that exercise modifies smoking topography (Katomeri & Taylor 2006;
      Mikhail, 1983; Reeser, 1983; Zacny & Stitzer, 1985).

      Recently, Faulkner and colleagues (2011; N = 18) were the first to implement a handheld
      smoking topography device (CReSS Pocket) to measure smoking behaviour in the context of an
      acute bout of exercise after a temporary period of abstinence. They found that brisk walking
      influences an individual's smoking topography. In specific, participants assigned to the
      exercise condition smoked less per puff and took shorter puff durations, compared to the
      passive sitting condition. Overall, smoking topographical studies require further
      investigation due to methodological flaws in order to allow for the objective collection of
      smoking behaviour data and improved external validity in a sufficiently powered study.
      Furthermore, the role of cravings, withdrawal and affect as potential mediators of
      topographical changes due to exercise is a novel area of research.
    

Intervention name(s): Moderate Exercise Group; Passive Sitting Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will be required to walk briskly (equivalent to moderate intensity) on a treadmill for 10 minutes.; Participants will be required to sit passively for 10 minutes on a chair.
Other intervention name(s): Physical activity; Sedentary
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: exercise; topography; cravings; smoking behaviour