bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of a New Biomechanical Device
Condition: Osteoarthritis; Joint Replacement; Fractures
MeSH terms: Osteoarthritis
Study type: Observational

Summary: 
      The purpose of this study is to examine (retrospectively) the effect of a new biomechanical
      device on gait patterns of patients suffering from musculoskeletal disorders. The analysis is
      conducted on an existing database of the therapy center.
    

Detailed description: 
      Patients treated in the therapy center undergo a computerized gait test and complete several
      pain and function questionnaires at fixed time point. We examined the effect of the treatment
      on the level of pain, function and quality of life as well as on the gait patterns of these
      patients. Measurements were taken at baseline, after 3 months, and after 6 months.
    

Intervention name(s): APOS biomechanical gait system
Intervention type(s): Device
Intervention description(s): a biomechanical device including 2 hemispheric biomechanical elements attached to a platform in a form of a shoe. the biomechanical device is calibrated to each patient by a physiotherapist specialized with the treatment methodology. patient are instructed to walk indoor with the device. time of exercise is gradually increase
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients suffering from one of the following conditions: knee\hip OA, knee\hip joint
        replacement, ankle fractures\instability, NSLBP
Social Functioning in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      There are two research purposes of this study. One is to explore which psychosocial issue or
      biological issue would affect the social function among people with schizophrenia. The other
      one is to explore which social function would affect the job tenure among people with
      schizophrenia. There are 60 participants diagnosed with schizophrenia and divided into two
      groups, employment and unemployment. we will use several social function tests to collect
      social function, PANSS to evaluate their psychotic symptoms. And then we will compare and
      analysis the data through statistic software. Finally, we will have he answer about how
      social skills affect the social function and which social skill would affect the job tenure
      among people with schizophrenia.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        schizophrenia
Efficacy and Safety of Multisite Cardiac Resynchronization Therapy
Condition: Ventricular Tachycardia
MeSH terms: Tachycardia; Tachycardia, Ventricular
Study type: Interventional

Summary: 
      Cardiac resynchronization therapy (CRT) is a proven therapy in patients with severe left
      ventricular (LV) dysfunction with ejection fraction (EF)<35%., moderate to severe congestive
      heart failure and wide QRS in ECG. Positive response presents as improvement in quality of
      life, decrease in congestive hrat failure symptoms and signs, improvements in
      echocardiographic measurements and longer survival. About 30% of the patients do not respond
      to this treatment.

      A decrease in clinical response to CRT is expected in patients with those predictors:
      advanced age, male, ischemic etiology of cardiomyopathy, Non-LBBB pattern in ECG, lack of
      mechanical dyssynchrony, large scar in LV, congestive heart failure stage IV, and non-cardiac
      co-morbidities (lung disease, pulmonary hypertension, renal failure and diabetes).

      There are few solutions to increase the rate of clinical response to CRT, for example:
      endocardial pacing of LV or pacing a few simultaneous sites on LV. A study that investigated
      a method of simultaneous pacing on LV of patients with congestive heart failure and LBBB with
      QRS>150ms has shown major improvement of cardiac contraction (increased dP/dtmax) compared to
      a single pacing site over a postero-basal or lateral wall site).

      Implantation of pacemaker leads- one in right ventricle (RV) and two over LV, i.e. multisite
      cardiac resynchronization therapy (MSCRT), has a few potential advantages, compared to
      conventional CRT.
    


Intervention name(s): Pacing
Intervention type(s): Procedure
Intervention description(s): In this study we intend to include patients that have indication to and are intended to undergo CRT implantation with an additional electrode on LV, that have inclusion criteria and have signed an informed consent.
In this study we will include 20 patients for each study arm (overall 100)- each patient will have both treatment configurations and these two will be compared
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: LV- Left Ventricular; CRT- Cardiac resynchronization therapy; MSCRT- Multisite Cardiac resynchronization therapy (P-pacemaker; D-defibrillator); BBB -bundle branch block
Efficacy of Massage Applied by the Parents in Hospitalized Premature Birth (PreMas)
Condition: Massage; Premature Infant; Premature Birth; Preterm Infant
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      The purpose of this study was to analyze the efficacy of massage therapy and kinesiotherapy,
      applied by the parents of hospitalized preterm infants, in the improvement of the biological
      state, neuromotor activity and other associated factors.
    

Detailed description: 
      Premature infants are prematurely deprived of the cutaneous stimulation provided during
      intrauterine development and of the continuous contact with their parents. It has and adverse
      effect on both psychological and biological development of the child.

      Knowledge of these factors has led many neonatal units to begin to introduce therapeutic
      massage protocols to facilitating satisfactory neuromotor and anthropometric development of
      preterm infants.

      In this study, premature newborns were assigned to one of two groups:

      A: Control Group. B: Massage and kinesiotherapy Group, 15 minutes twice a day.
    

Intervention name(s): Protocol of massage therapy and kinesiotherapy
Intervention type(s): Behavioral
Intervention description(s): Infants received massage and kinesiotherapy, applied by parents, twice a day; 15 minutes each.
Other intervention name(s): Massage; Massage Therapy; Tactile Kinesthetic Stimulation
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Intervention model description: The control group included all preterm infants from months 1-6 and 19-24 of the study. The intervention group included all the premature newborns from the 7-18 months of the study.
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Premature Infant; Massage; Tactile Kinesthetic Stimulation
Treatment of Prostate Cancer With Firmagon®
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      How are testosterone levels of patients with prostate cancer under treatment with Firmagon®
      changing.

      Former studies showed a quick fall of testosterone levels after start of therapy with
      Firmagon® and a quick recovery when therapy is stopped. The investigators want to prove this
      in a normal outpatient urologist setting. Furthermore data is collected to prove the
      adherence to the German S3-Guideline for the treatment of prostate cancer.
    


Intervention name(s): Degarelix
Intervention type(s): Drug
Intervention description(s): subcutaneous injection
Other intervention name(s): Firmagon®
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        adult male patients of outpatient urological medical practice
      
Keywords: testosterone; S3-Adherence; Quality of Life
Written Disclosure Therapy for Anxiety and Stress in Patients With Chronic Lung Disease
Condition: Chronic Lung Diseases; COPD; Pulmonary Fibrosis
MeSH terms: Lung Diseases; Pulmonary Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether Written Disclosure Therapy (WDT) is of any
      benefit to patients with chronic lung diseases who are participating in pulmonary
      rehabilitation.
    

Detailed description: 
      Chronic lung diseases are typically associated with impaired quality of life, stress, and
      anxiety. Written disclosure therapy (WDT) reduces stress in patients with a variety of
      chronic illnesses. We sought to determine if written disclosure therapy benefits patients
      with chronic lung diseases when it is added as a component to the pulmonary rehabilitation
      program.
    

Intervention name(s): Disclosure Writing (Written Disclosure Therapy); Neutral (Sham) Writing
Intervention type(s): Other; Other
Intervention description(s): Patients write about a stressful life experience; Patients write about neutral subjects
Other intervention name(s): Written Disclosure Therapy; Sham Writing (Controls that wrote about neutral subjects)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dyspnea; Written Disclosure Therapy; COPD; Pulmonary Fibrosis; Chronic Lung Diseases; Pulmonary Rehabilitation
Exercise Training in Coronary Artery Disease Patients After Stenting
Condition: Stent Restenosis; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      To determine the effect of exercise training on cardiac outcomes in coronary artery disease
      patients after Stenting. There is a need to develop strategies, not only to prevent
      restenosis but also to improve patients' functional status and perception of well-being. In
      particular, it is not well defined whether exercise training can reduce the restenosis rate
      and improve the outcome after PCI.
    

Detailed description: 
      Based on an analysis of literature reviews, psychological symptoms (such as depression and
      anxiety), angina, vital exhaustion, and dyspnea have been observed to have the most
      significant influence on the quality of life in people with CAD. Almost half of the patients,
      after an initial encouraging improvement in functional capacity and quality of life (QOL)
      after the PCI, deal with recurrent chest pain that requires medical attention, reduces
      functional capacity, and creates a status of psychological distress.
    

Intervention name(s): Structured In-Patient and Home plan; Conventional Therapy
Intervention type(s): Other; Other
Intervention description(s): A patient education session and a protocol comprise of 3 days. It consists of three different levels having progressive activities. The in-patient protocol will start from the day of the procedure. Each level contains 2 to 6 tasks, performed in sets of 5-10 repetitions 3 times a day. Home plan: Walking 3 days a week starting from normal pace ((RPE: 8-9) for10 minutes and progressively increased intensity and duration over the period of 12 weeks (RPE: 13-14).; In-Patient: Wound care, Bed mobility:
AROMS (10 Reps*3sets*TD), Breathing Exercise (10 Reps*3sets*TD), Mobilization (Walk as per patient tolerance) Patient Education: To keep the heart healthy Diet Avoid strenuous exercise and lifting heavy objects Avoid valsalva manure, Quit smoking Lower cholesterol levels, Maintain a healthy weight Control other conditions, such as diabetes and high blood pressure Take medications as prescribed by your doctor Get regular exercise: Walking at a normal pace as per tolerance (RPE up to 10)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Coronary artery diseases; Exercise training; Stenting
Treatment of Actinic Keratosis With 5% KOH Solution
Condition: Actinic Keratoses
MeSH terms: Keratosis, Actinic; Keratosis
Study type: Observational

Summary: 
      This is a prospective single-arm multicenter medical device study to investigate the clinical
      efficacy and safety of the treatment of actinic keratosis with a 5% potassium hydroxide
      solution.

      In total, 68 patients with actinic keratosis grade I/II, who meet all inclusion criteria and
      do not meet none of the exclusion criteria are to be enrolled and topically treated twice
      daily for up to 3 cycles of 14 days of treatment followed by 14 non-treatment days.

      The primary objective is treatment success at the individual end-of-treatment visit of all AK
      lesions present at baseline and treated with the investigational product.

      Beside this, adverse events will be collected at each visit and evaluated in order to
      investigate clinical safety.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients of the participating study sites (medical practice and experienced in the
        management and treatment of patients suffering from the disease as mentioned in the
        inclusion criterion), who fulfill all inclusion criteria and do not fulfill any of the
        exclusion criteria, are eligible for participation in the TAKKOH study
A Trial Examining the Treatment of Common Warts With Combination Liquid Nitrogen (LN2) and Cantharidin
Condition: Verruca Vulgaris
MeSH terms: Warts
Study type: Interventional

Summary: 
      The purpose of the study was to see if liquid nitrogen, a commonly used treatment for warts,
      is more effective if it is used alone, or if it is more effective if combined with
      cantharidin, a topical treatment also commonly used for warts (verruca vulgaris).
    


Intervention name(s): Liquid nitrogen and cantharidin; Liquid nitrogen and topical placebo
Intervention type(s): Drug; Drug
Intervention description(s): Liquid nitrogen applied to wart(s), then cantharidin 1% topical applied afterward.; Liquid nitrogen applied to wart(s), then placebo vehicle applied thereafter.
Intervention MeSH terms: Cantharidin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Warts; Verruca vulgaris; Liquid Nitrogen; Cantharidin; combination treatment
Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
Condition: Opioid-Induced Constipation (OIC)
MeSH terms: Constipation; Opioid-Induced Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of
      opioid-induced constipation in patients with non-cancer-related pain, including those
      patients that have inadequate response to laxative therapy (LIR).
    


Intervention name(s): NKTR-118; NKTR-118; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 12.5 mg oral tablet once daily; 25 mg oral tablet once daily; Oral tablet once daily
Intervention MeSH terms: Naloxegol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Non-Cancer-Related Pain, Opioid-Induced Constipation
The Effect of MIND-BE Program on Mental Health Parameters (Mindfulness Based Empowerment)
Condition: Resilience; Posttraumatic Growth; Mindfulness; Self-compassion; Mental Health
Study type: Interventional

Summary: 
      This study will be carried out in a pre-test-post-test, randomized controlled (parallel),
      experimental order in order to examine the effect of the MIND-BE program applied to intensive
      care nurses on mental health parameters. The hypothesis of this study is that MIND-BE program
      increases resilience, posttraumatic growth, mindfulness, self-compassion levels, and reduces
      mental symptoms.
    

Detailed description: 
      In the study, the MIND-BE program will be applied to the nurses (n=49) in the intervention
      group. Considering the studies on mindfulness on nurses, it is planned to practice
      mindfulness for 60 minutes once a week for 8 weeks. Mindfulness practice will be done online
      using appropriate platforms on the days and hours determined by Hilal Altundal (H.A.), who
      has a Mindfulness Institute-approved document. In the control group (n=49), no intervention
      will be made for 8 weeks. Results will be collected through data collection forms before the
      MIND-BE program, after the MIND-BE program is completed (8th week), and one month after the
      MIND-BE program is completed (12th week). The data collection forms applied to all nurses in
      the intervention and control groups at the beginning of the study will be applied again at
      the end of the 8th and 12th weeks. The primary expected outcome of the study is the effect of
      the MIND-BE program on nurses' resilience, posttraumatic growth, mindfulness, and
      self-compassion. The secondary expected result of the study is to determine the effect of the
      MIND-BE program on the mental health of nurses.
    

Intervention name(s): Mindfulness
Intervention type(s): Other
Intervention description(s): In the study, for 60 minutes once a week for 8 weeks MIND-BE program will be applied to nurses. The program includes formal and informal practices of mindfulness ("Getting started, Introduction to MIND-BE, Noticing the autopilot, Power of attention, Simple awareness, Eating awareness, Body awareness, Breath awareness, Sitting awareness, Stress and reactions, Vision awareness, Challenging emotions and situations in business life, Awareness in business life, Awareness and communication, Awareness and compassion, Developing your own practice).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, parallel, two-arm, randomized controlled clinical trial
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Resilience; Posttraumatic Growth; Mindfulness; Self-compassion; Mental health
The Efficacy of Everolimus in Reducing Total Native Kidney Volume in Polycystic Kidney Disease Transplanted Recipients
Condition: Autosomal Dominant Polycystic Kidney Disease
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators multicenter randomized open-labelled study will investigate the efficacy of
      an everolimus based immunosuppression in reducing total native kidney volume in kidney
      recipients with autosomal dominant polycystic kidney disease compared to a calcineurin
      inhibitor-based immunosuppression.
    

Detailed description: 
      Kidney graft recipients receiving a firs kidney graft (between 6 months and 5 years
      post-transplantation) will be randomized 1:1 to receive an everolimus based immunosuppression
      (in association with steroids and mycophenolate mofetil) or to continue their calcineurin
      inhibitor-based immunosuppression regimen. The primary objective will be the reduction of
      total native kidney volume after a 2-years treatment period.
    

Intervention name(s): Everolimus; Calcineurin inhibitors maintenance
Intervention type(s): Drug; Drug
Intervention description(s): Change from a calcineurin inhibitors-based immunosuppression to an everolimus-based immunosuppression; Usual treatment
Other intervention name(s): everolimus conversion; calcineurin-inhibitors based immunosuppression
Intervention MeSH terms: Everolimus; Calcineurin Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autosomal dominant polycystic kidney disease; cyst; kidney; liver; kidney transplantation; IF/TA; fibrosis; DSA; mTOR inhibitors; calcineurin inhibitors
A Study to Evaluate the Effect of Gefapixant (AF-219/MK-7264) on Methacholine Hyper-reactivity in Participants With Asthma (MK-7264-009)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, double-dummy, placebo-controlled, three-way cross-over,
      single centre study in participants with asthma undergoing inhalation of methacholine and
      adenosine triphosphate (ATP) to assess the provocative concentration (PC20) response of two
      dose levels of gefapixant (AF-219) compared with placebo.
    


Intervention name(s): Gefapixant 50 mg; Gefapixant 300 mg; Placebo to mimic 50 mg tablets; Placebo to mimic 300 mg tablets
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Gefapixant 50 mg tablet administered orally; Gefapixant 300 mg tablet administered orally; Sugar pill manufactured to mimic gefapixant 50 mg tablets; Sugar pill manufactured to mimic gefapixant 300 mg tablets
Other intervention name(s): AF-219; MK-7264; AF-219; MK-7264
Intervention MeSH terms: Mitomycin; Cisplatin; Ifosfamide; Mesna
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Big Decisions - an Evaluation of a Comprehensive Sexual Health Curriculum Pilot in Ecuador During 2019
Condition: Adolescent Sexual Behavior
Study type: Interventional

Summary: 
      The purpose of this study is to assess the efficacy of the "Big Decisions" Adolescent sexual
      and reproductive health (ASRH) Curriculum via a pilot program with an educational
      experimental trial design.
    


Intervention name(s): Pilot Group
Intervention type(s): Other
Intervention description(s): 12 Weeks, 1-1 Hour Session Per Week for 10 Total Curriculum Sessions,including 1 Week of Orientation and 1 Week of Debriefing/Program Graduation.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Adolescence; reproductive health