bioihbjkbjnl/mcl2 huggingface dataset:
Experimentation of an Ankle Mobilization Device for the Rehabilitation of Patients With Acquired Brain Injuries.
Condition: Acquired Brain Injury
MeSH terms: Brain Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      The proposed clinical investigation plan is a randomized controlled pivotal study with 2
      parallel groups, has a total duration of two years. For the study, 30 pediatric patients
      suffering from acquired brain injury will be recruited at the Scientific institute Eugenio
      Medea.

      The primary aim of this study is to assess the clinical benefit of using an ankle
      mobilization device for the rehabilitation of pediatric patients with acquired brain
      injuries, on its clinical performance and its risks, and on its safety.

      The efficacy of the treatment will be evaluated in terms of ankle range of motion (primary
      outcome). The effects of the treatment on musculoskeletal plasticity will be studied using an
      isokinetic machine and functional magnetic resonance imaging will provide information on
      variations of reactivity in the motor cortical network. Ease of use, safety and usability of
      the device will also be evaluated.
    


Intervention name(s): Ankle active and passive mobilization using an Ankle mobilization device
Intervention type(s): Device
Intervention description(s): The treatment consists in 20 rehabilitation sessions, 5 times/week for 4 weeks. The device is capable of generating ankle dorsi/plantarflexion movements using two activation modes: passive and assistive. In the passive mode the device generates a movement pattern which the patient follows passively without exerting any force on the device. During the assistive mode, the device follows the active movement of the patient. During the intervention, these two modes will be alternated.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Pelvic Floor Muscle Training With Stabilization Exercises With Various Intensity in Women With Stress Urinary Incontinence
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      This study will evaluate the safety, tolerability and efficacy of high- and low-intensity
      PFMT with stabilization exercises in women with SUI
    

Detailed description: 
      This is a randomized interventional parallel study to evaluate the effect of PFMT with
      stabilization exercises of high and low intensity in women with SUI
    

Intervention name(s): Pelvic Floor Muscle Training (PFMT)
Intervention type(s): Other
Intervention description(s): The method of first choice in SUI treatment according to the International Continence Society (ICS) is training of the pelvic floor muscles. Pelvic floor muscle training (PFMT) is a method based on scientific evidence, defined by the ICS as repeated selective voluntary contraction and relaxation of specific pelvic floor muscles. It is important to train the strength and endurance of the pelvic floor muscles but also their relaxation (Abrams, 2018; Arnold, 2014; Bo, 2013).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stress urinary incontinence;; 2D/3D ultrasound; Pelvic floor muscle training
Neurophysiology-based Intervention of Foot Dysfunction in Sportive Children
Condition: Flatfoot, Flexible; Sports Physical Therapy; Child Development
MeSH terms: Flatfoot
Study type: Interventional

Summary: 
      The goal of the clinical trial study is to test the effect of the individual complex
      physiotherapy intervention program in the children actively playing soccer with flatfoot or
      valgus foot.

      The aims are:

        1. see if the medial longitudinal arch will by actively more higher after the intervention

        2. see if the type of the foot will change toward more neutral type after the intervention

        3. see if the transfer of the centre of body mass through the foot during the gait will
           directed in more neutral line after the intervention

      The participants will undergo clinical assessment of short kinesiology assessment visually in
      underwear and barefoot. Then Participant will be tested for balance test in narrow stance
      with open and closed eyes, and single.leg stance with open eyes on the pressure mat. Finally,
      participant will walking in self-selected normal speed through the gait pressure mat. Eaxh
      procedure will be measured twice, before the program start and after the 4 weeks when the
      program finish. Researchers will compare these two measurement for the changes.
    

Detailed description: 
      The aim of the study was to evaluate the effect of the neurophysiology-based (NB)
      intervention program in sporting children with foot problems. The NB intervention composed
      from evidence based and neurophysiology-based methods: 1) Janda´s sensorimotor stimulation,
      2) Dynamic neuromuscular stabilisation concept (DNS), 3) Toe and foot muscle strengthening,
      4) foot support base related exercises, and 5) somatic-sensory facilitation techniques. The
      proposed NB intervention lasted 4 weeks with each 45minutes long session twice a week. Each
      session was leaded by experienced physiotherapist in clinical practice gym, in one-to-one
      regime to ensure quality of the exercising, using progressive steps and some additional
      balance pads and small ball. The research assessments were conducted pre- and
      post-intervention (T0 and T4) and consisted of personal data and health questionnaires (name,
      date of the birth, laterality, shoe size, diseases, injuries and surgery), clinical examining
      (standing posture, core stabilisation function in supine position, foot posture index),
      laboratory testing (postural stability and normal walking on pressure mat). Data were edited,
      analysed and compared pre- and post-intervention.
    

Intervention name(s): Neurophysiology-based intervention
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Greek Study on Work Productivity and Sleep in Patients With Rheumatic Diseases Treated With Adalimumab
Condition: Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis
MeSH terms: Spondylitis; Arthritis; Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylarthritis; Spondylitis, Ankylosing; Rheumatic Diseases; Collagen Diseases
Study type: Observational

Summary: 
      Treatment with tumor necrosis factor (TNF) inhibitors, especially adalimumab, demonstrated an
      improvement in work productivity in participants with rheumatic diseases: rheumatoid
      arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). Limited data was
      available for the effect of adalimumab treatment on sleep in all three diseases (RA, PsA, and
      AS) and no data was available for the effect of adalimumab treatment on work productivity in
      PsA. This long term Health-Related Quality of Life (HRQL) observational study was conducted
      to evaluate the effect of treatment with adalimumab on work productivity and sleep
      disturbance in Greek participants with moderate to severe rheumatic diseases (RA, PsA, and
      AS).
    

Detailed description: 
      This was a multi-center, uncontrolled, prospective, observational study in participants with
      moderate to severe rheumatic disease (RA, PsA, or AS) who received adalimumab under normal
      clinical practice in accordance with Summary of Product Characteristics (SmPC), with or
      without other anti-rheumatic treatments.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received
        adalimumab in accordance with approved label, as prescribed by the physicians under normal
        clinical practice.
      
Keywords: Ankylosing spondylitis; Sleep; Psoriatic arthritis; Work Productivity; Rheumatoid Arthritis
Mindfulness Training for Smoking Cessation
Condition: Cigarette Smoking; Tobacco Smoking; Nicotine Dependence; Smoking Cessation
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effects of mindfulness training (MT) compared to
      standard Smoking Cessation Therapy (SCT) on smoking cessation and stress provocation in
      individuals trying to quit smoking.
    


Intervention name(s): Mindfulness Training; Smoking Cessation Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 8 sessions of behavioral treatment for smoking cessation; 8 sessions of behavioral treatment for smoking cessation
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mindfulness; smoking; stress
Safety and Efficacy of Neoadjuvant Radiochemotherapy in Adenocarcinoma of the Gastric-oesophageal Junction
Condition: Esophageal Neoplasms; Stomach Neoplasms
MeSH terms: Neoplasms; Adenocarcinoma; Stomach Neoplasms; Esophageal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine the dose limiting toxicity and the maximum
      tolerable dose of the radiochemotherapy with Docetaxel and Oxaliplatin in patients with
      adenocarcinoma of the gastric-oesophageal junction.
    

Detailed description: 
      Radiotherapy starts on day 1 of chemotherapy after the application of Docetaxel and
      Oxaliplatin and will be administered in single doses of 1.8 Gy once daily and five times a
      week for 5 weeks.

      In the sixth treatment week a boost of 3 further radiations with 1.8 Gy will be applied.

      Simultaneous chemotherapy:

      Initially, in part A of the study the maximum tolerable dose (MTD) for the simultaneous
      chemotherapy will be identified with a 3-step dose escalation scheme:

      Level 1: Docetaxel: 20 mg/m2 Oxaliplatin 40 mg/m2 i.v., Level 2: Docetaxel: 20 mg/m2
      Oxaliplatin 50 mg/m2 i.v., Level 3: Docetaxel: 25 mg/m2 Oxaliplatin 50 mg/m2 i.v.,

      The treatment starts with 3 patients in level 1. If no dose limiting toxicities appear, it
      will be switched to dose level 2. The same applies for the switch from level 2 to level 3. If
      a DLT appears on one level, a further 3 patients will be treated within this dose level.

      If in one level at least 2 of 6 patients show DLT, the subjacent level will be defined as the
      maximum tolerable dose (MTD).
    

Intervention name(s): Docetaxel, Oxaliplatin; Radiotherapy
Intervention type(s): Drug; Procedure
Intervention description(s): weekly doses; regular fractions
Intervention MeSH terms: Docetaxel; Oxaliplatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chemoradiation; docetaxel; oxaliplatin; gastric; neoadjuvant; radiochemotherapy
A Two-part, Study to Compare the Pharmacokinetics and Dose Proportionality of up to 6 Chronocort Formulations
Condition: Adrenal Insufficiency; Congenital Adrenal Hyperplasia
MeSH terms: Adrenal Hyperplasia, Congenital; Adrenogenital Syndrome; Adrenal Insufficiency; Hyperplasia
Study type: Interventional
Phase: Phase 1

Summary: 
      This was an open label, randomised, single dose study, comprising Part A (undertaken in two
      separate three-period crossover cohorts denoted as A1 and A2) and Part B (undertaken in one
      four-period crossover cohort), to evaluate the PK of Chronocort® in healthy male volunteers.
      The washout interval in both Part A and Part B was 1-week in between each treatment period.
    


Intervention name(s): Chronocort
Intervention type(s): Drug
Intervention description(s): Modified formulation of hydrocortisone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
TPF Plus Cisplatin and Radiotherapy vs TPF Plus Cetuximab and Radiotherapy to Treat Head and Neck Cancer.
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      An Open Label Randomized, Multi-Centre Phase III Trial of TPF Chemotherapy Plus Concomitant
      Treatment With Cisplatin and Conventional Radiotherapy Versus TPF Chemotherapy Plus
      Concomitant Cetuximab and Conventional Radiotherapy in Locally Advanced, Unresectable Head
      and Neck Cancer.
    

Detailed description: 
      This study is being sponsored by a cooperative medical group.
    

Intervention name(s): TPF, radiotherapy and cisplatin.; TPF, radiotherapy and cetuximab.
Intervention type(s): Other; Other
Intervention description(s): 3 cycles of: cisplatin: 75 mg/m2, i.v., 1 hour, once daily docetaxel: 75 mg/m2, i.v., 1 hour, once daily 5-fluorouracil: 750 mg/m2, i.v., 24 hours, 5 days Radiotherapy: 70Gy, divided into daily doses of 2 Gray (total days: 35) Cisplatin: 100 mg/m2, i.v., 1 hour, 3 days; 3 cycles of: cisplatin: 75 mg/m2, i.v., 1 hour, once daily docetaxel: 75 mg/m2, i.v., 1 hour, once daily 5-fluorouracil: 750 mg/m2, i.v., 24 hours, 5 days Radiotherapy: 70Gy, divided into daily doses of 2 Gray (total days: 35) Cetuximab: 400 mg/m2, i.v, 2 hours, 1 day Cetuximab: 250 mg/m2, i.v, 1 hour, 7 days
Other intervention name(s): TPF plus radiotherapy and cisplatin; TPF plus radiotherapy and cetuximab
Intervention MeSH terms: Cisplatin; Cetuximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Head and Neck Cancer
Trial to Evaluate Radiotherapy Followed by Endocrine Therapy Vs Endocrine Therapy Alone for PSA Failure After Radical Prostatectomy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate radiotherapy followed by endocrine therapy in
      comparison with endocrine therapy alone for PSA failure after radical prostatectomy.
    

Detailed description: 
      A randomized controlled trial is conducted in Japan to evaluate radiotherapy followed by
      endocrine therapy for PSA failure after radical prostatectomy. Patients who have PSA failure
      after radical prostatectomy under a diagnosis of localized prostate cancer (T1-2 N0M0) are
      randomized into treatment group of either radiotherapy followed by endocrine therapy or
      endocrine therapy alone. Urologic Oncology Study Group (UOSG) in the JCOG composed of 36
      specialized institutions will recruit 200 patients. The primary endpoint is time to treatment
      failure (TTF) of bicalutamide and secondary endpoints are TTF of protocol treatment,
      progression free survival, overall survival, adverse events and quality of life (QOL). The
      Clinical Trial Review Committee of the Japan Clinical Oncology Group (JCOG) approved the
      protocol on April 13, 2004, and the study was activated on May 17, 2004.
    

Intervention name(s): endocrine therapy; radiotherapy
Intervention type(s): Drug; Procedure
Intervention description(s): Drug: endocrine therapy; Procedure/Surgery: radiotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: prostate cancer; radical prostatectomy; PSA failure; RCT; radiation; endocrinotherapy
Bamberg Diabetes Transitional Care Pilot Study
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      Bamberg County residents who has been diagnosed with or is at high risk for diabetes, may be
      eligible for a clinical research study to improve diabetes self-management and decrease
      hospital re-admissions.

      The purpose of this study is to compare the effectiveness of three hospital discharge
      follow-up methods:

        1. standard of care,

        2. a nurse telephone intervention (care coordination and education), and

        3. an in-home community health worker intervention (care coordination and education).
    


Intervention name(s): Surveys; Telephonic Nurse Intervention; In-person Community Health Worker
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The following information will be collected: demographics, literacy screener, depression screener, medication adherence, self-efficacy, tobacco use, patient activation, health questionnaire, eating patterns, diabetes self-management assessment, stages of change questionnaire, vitals, and self-care behaviors.; A nurse will contact patients by phone at least weekly for month 1 and at least every other week for months 2 and 3 and will collect the following information: medication adherence, discharge plan adherence, problem solving, diet and physical activity issues and to assess self-management, dietary, and physical activity improvements. In addition the nurse will link participants with resources.; An in-person Community Health Worker will contact patients in-person at least weekly for month 1 and at least every other week for months 2 and 3 and will collect the following information: medication adherence, discharge plan adherence, problem solving, diet and physical activity issues and to assess self-management, dietary, and physical activity improvements. In addition the nurse will link participants with resources.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Diabetes
Retrospective Evaluation of the Effect of Iron (Fe) Infusion on Complications in Anemic Patients Undergoing Thoracotomy
Condition: Iron Deficiency Anemia; Iron Deficiency Anemia Treatment
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Study type: Observational

Summary: 
      In patients who underwent thoracotomy due to lung malignancy; It is desired to investigate
      whether there is a difference in terms of postoperative results between those with and
      without anemia, and those with iron deficiency anemia (IDA) who underwent intravenous iron
      replacement and those who did not, according to the hemoglobin value in their preoperative
      examinations.
    


Intervention name(s): iron
Intervention type(s): Other
Intervention description(s): iron treatment
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients undergone thoracotomy
AlloStim® Immunotherapy Dosing Alone or in Combination With Cryoablation in Metastatic Colorectal Cancer
Condition: Colorectal Cancer Metastatic
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single center, open label dose frequency escalation study of CryoVax®. personalized
      anti-tumor vaccine protocol combining the cryoablation of a selected metastatic lesion with
      intra-lesional immunotherapy with AlloStim®. The in-situ (in the body) cancer vaccine step
      combines killing a single metastatic tumor lesion by use of cryoablation in order to cause
      the release of tumor-specific markers to the immune system and then injecting bioengineered
      allogeneic immune cells (AlloStim®) into the lesion as an adjuvant in order to modulate the
      immune response and educate the immune system to kill other tumor cells where ever they
      reside in the body.
    

Detailed description: 
      Colorectal cancer (CRC) ranks as the third most common cancer worldwide. Metastasis is the
      main reason of death in CRC patients. The current drugs used to treat colorectal cancer
      provide important treatment options for patients, their limitations including drug
      resistance, poor efficacy and severe side effects. Development of new therapeutic strategies
      for KRAS mutant as well as BRAF mutant tumors are therefore highly needed in order to offer a
      new category of drug (immunotherapy). This study targets the population of mCRC patients that
      have progressed after two lines of chemotherapy and are not eligible for targeted therapies.
      The study will assess six different dosing schedules. A standard 3 plus 3 study design will
      be used. The starting frequency for each dosing schedule will be escalated in subsequent
      groups of patients. The study will evaluate safety of increased frequency of AlloStim® dosing
      and anti-tumor effect of the new proposed dose and frequency schedule.
    

Intervention name(s): AlloStim; Cryoablation
Intervention type(s): Biological; Procedure
Intervention description(s): AlloStim is an activated living CD4+ Th1 memory cell derived from the blood of normal blood donors and intentionally mismatched to the recipient. AlloStim is bioengineered to express high levels of Type 1 inflammatory cytokines (such as interferon-gamma, TNF-alpha, GM-CSF) and immunomodulatory molecules such as CD40L. AlloStim has CD3/CD28-coated microbeads attached to assure activation upon infusion.; Percutaneous partial cryoablation of a single metastatic tumor lesion in the liver. The procedure is conducted under CT or ultrasound image-guidance
Other intervention name(s): CryoVax
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: colorectal cancer; KRAS mutant; BRAF mutant; metastatic; liver metastasis; AlloStim®; cryoablation; cancer vaccine; immunotherapy; MSI-S
A Comparative Study of Papacarie® and the Conventional Method for Dental Caries Treatment
Condition: Dental Caries; Secondary Dental Caries; Personal Satisfaction
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The purpose study are to evaluate the efficacy of Papacarie® for caries removal in comparison
      to the conventional drilling method.
    

Detailed description: 
      Dental caries in children continues to affect a significant portion of the world population,
      especially in developing countries. There are many techniques used for dental caries
      treatment. The conventional method is to remove caries and prepare the cavity using dental
      burs. Disadvantages of this method; however, include the patients' repulsion of drilling, and
      possible thermal changes on tooth surface that may have an effect on the dental pulp tissues.
      In addition, the drilling technique frequently requires local anesthesia injections and
      sometimes results in the removal of sound tooth tissues. To overcome these problems and
      preserve the healthy dental tissues, the chemo-mechanical caries removal method was
      developed. The advantage by chemomechanical caries removal include less traumatic, less need
      local anesthesia, reduced chance of dental pulp exposure. And also it could be benefit to
      medical compromised patients.

      Papacarie® is a new chemo-mechanical technique for caries removal with few published research
      and case reports. A randomized controlled trial is therefore needed to determine the efficacy
      of its use in general population. The aims of this study are to evaluate the efficacy of a
      chemo-mechanical system (Papacarie®) for caries removal in comparison to the conventional
      drilling method.
    

Intervention name(s): Papacarie®; Conventional method
Intervention type(s): Device; Procedure
Intervention description(s): Papacarie® is chemo-mechanical method for caries removal; caries removal by using rotary instrument.
Other intervention name(s): Chemo-mechanical removal of decays Agent
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Chemo-mechanical caries removal; Papacarie®