bioihbjkbjnl/mcl2 huggingface dataset:
Study of Health Promotion in Patients With Early-Stage Breast or Prostate Cancer
Condition: Breast Cancer; Depression; Fatigue; Malnutrition; Prostate Cancer; Psychosocial Effects of Cancer and Its Treatment
MeSH terms: Breast Neoplasms; Prostatic Neoplasms; Malnutrition; Fatigue; Depression
Study type: Interventional

Summary: 
      RATIONALE: Telephone counseling by a nutritionist and a personal trainer may improve physical
      function and quality of life in patients who have early-stage breast cancer or prostate
      cancer.

      PURPOSE: Randomized clinical trial to compare the effectiveness of a home-based, diet and
      exercise-based counseling program with that of a standard home-based counseling program in
      promoting health in patients who have early-stage breast cancer or prostate cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the efficacy of a diet and exercise-based home-based counseling program versus a
           standard home-based counseling program for improving physical function at 6 and 12
           months for patients with early-stage breast or prostate cancer.

        -  Compare the effects of these home-based programs on diet quality, physical activity,
           weight status, depression, and quality of life of these patients.

        -  Compare the factors, such as gender, race, and social support, that interact with these
           home-based programs to predict program efficacy in these patients.

      OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 arms.

        -  Arm I: Patients receive home-based telephone counseling by a personal nutritionist and a
           personal trainer.

        -  Arm II: Patients receive home-based standard health telephone counseling in unrelated
           areas of cancer care (e.g., sun exposure, screening, and falls prevention).

      In both arms, counseling continues every 2 weeks for 6 months.

      Patients are followed at 6 months.

      PROJECTED ACCRUAL: A total of 420 patients (210 per arm) will be accrued for this study.
    

Intervention name(s): fatigue assessment and management; nutritional support; physical therapy; psychosocial assessment and care; quality-of-life assessment
Intervention type(s): Procedure; Procedure; Procedure; Procedure; Procedure
Primary purpose: Other
Keywords: stage I breast cancer; stage II breast cancer; stage I prostate cancer; stage II B prostate cancer; stage II A prostate cancer; male breast cancer; fatigue; malnutrition; psychosocial effects of cancer and its treatment; depression
Study to Determine if Gardasil Vaccine is Safe and Effective in Lupus Patients
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      Cervical neoplasia is increased in women with SLE most likely due to cervical infection with
      human papilloma virus (HPV). 70% of cervical cancer is caused by HPV types 16 and 18.
      Gardasil vaccine prevents cervical infection with HPV types 16 and 18. Thus lupus patients
      (who are susceptible to cervical cancer) may benefit from getting Gardasil vaccine which can
      prevent cervical cancer. Vaccines are generally safe and efficacious in SLE but no studies
      have been done on the use of this vaccine in SLE. The investigators hypothesize that Gardasil
      vaccine is safe and effective in SLE. This study will look at vaccine safety in patients with
      mild to moderate and minimally active or inactive SLE and measure how well they make
      protective antibodies after receiving the vaccine. In other words this will check how well
      the vaccine works in SLE.
    

Detailed description: 
      To gather safety information and adverse events on the use of Gardasil® in mild to moderate
      and minimally active or inactive SLE.

      To gather information on SLE disease activity flares after vaccination with Gardasil®.

      To gather information on the immunogenicity or development of protective anti HPV antibodies
      SLE after vaccination with Gardasil®.
    

Intervention name(s): Gardasil
Intervention type(s): Drug
Intervention description(s): 0.5 ml Gardasil vaccine in single dose prefilled syringes at Visit 2, Visit 4 and Visit 6
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Lupus
A Safety and Efficacy Study of Inhaled R940343 in Patients With Mild to Moderate Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety, efficacy and tolerability of R940343 in
      the treatment of mild to moderate asthma.
    

Detailed description: 
      The study is a multi-center, randomized, double-blind, placebo-controlled, parallel group
      study comparing 2 doses of inhaled R343 bid to placebo over 8 weeks in patients with mild to
      moderate allergic asthma. Patients who meet specific inclusion and exclusion criteria after
      an initial screening evaluation and a single-blind, run-in period will be randomized to
      receive either R343 or placebo.
    

Intervention name(s): Placebo; R940343 1mg; R940343 2mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 puff bid or 2 puffs bid; R343 1mg, 1 puff bid; R343 2mg, 2 puffs bid
Other intervention name(s): R343; R343
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Accelerated Radiotherapy and Concomitant Chemo-radiotherapy in HNSCC
Condition: Oral Cancer; Oropharynx Cancer; Hypopharynx Cancer; Larynx Cancer
MeSH terms: Mouth Neoplasms; Oropharyngeal Neoplasms; Laryngeal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicentric randomized phase III trial comparing conventional radiotherapy with
      concomitant chemotherapy versus accelerated radiotherapy with concomitant chemotherapy versus
      very accelerated radiotherapy in patients with stage III-IV head and neck squamous cell
      carcinoma. The main end point is the event free survival.
    

Detailed description: 
      This is a multicentric randomized phase III trial comparing conventional radiotherapy with
      concomitant chemotherapy (arm A) versus middle accelerated radiotherapy with concomitant
      chemotherapy (arm B) versus very accelerated radiotherapy alone (arm C) in patients with
      stage III-IV head and neck squamous cell carcinoma (HNSCC). The main end point is the event
      free survival.

      The treatments are

      Bras A : Conventional radiotherapy given once daily, delivering 70 Gy in 7 weeks (5 fractions
      of 2 Gy per week) and chemotherapy: 5FU : 600 mg/m²/d, Paraplatin : 70 mg/m²/d, D1-4 and
      D22-25 and D43-46

      Bras B: middle accelerated radiotherapy delivering 70 Gy in 6 weeks and chemotherapy: 5FU :
      600 mg/m²/d, Paraplatin : 70 mg/m²/d, D1-5 and D29-33

        -  first part : radiotherapy given once daily delivering 40 Gy in 4 weeks and 20 fractions
           of 2 Gy

        -  second part : radiotherapy given twice daily with "concomitant boost" delivering 30 Gy
           in 20 fractions in 2 weeks (1,5 Gy x 2 / day)

      Bras C: very accelerated radiotherapy given twice daily delivering 64.8 Gy in 3.5 weeks in 36
      fractions of 1.8 Gy
    

Intervention name(s): Conventional radiotherapy 70 Gy in 7 weeks; middle accelerated radiotherapy 70 Gy in 6 weeks; very accelerated radiotherapy 64.8 Gy in 3.5 weeks; 5FU, Paraplatin
Intervention type(s): Procedure; Procedure; Procedure; Drug
Intervention description(s): 2 gy per fraction, 1 fraction per day, 5 fractions per week; 5 x 2gy/week until 40 Gy in 20 fractions and 4 weeks, then 2 fractions of 1.5Gy per day for 30 additional Gy in 2 weeks; 2 fractions of 1.8 Gy per day for 64.8 Gy in 3.5 weeks; 5FU 600mg/m²/D, Paraplatin 70mg/m²/D In arm 1: D1-4, 3 cycles during Rth (D1, D22, D43) In arm 2: D1-5, 2 cycles during Rth (D1, D29)
Intervention MeSH terms: Carboplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Head and neck squamous cell carcinoma; Radiotherapy; Chemotherapy
Endothelial and Microvascular Functions in Patients With Myocardial Ischemia
Condition: Microcirculation; Biomarkers; Myocardial Ischemia
MeSH terms: Myocardial Ischemia; Coronary Artery Disease; Ischemia
Study type: Observational

Summary: 
      Cardiovascular diseases (CVD) are responsible, throughout the world, for high mortality rates
      and cardiovascular morbidity. Endothelial dysfunction is the earliest marker of clinical
      atherosclerosis development. Human studies show that endothelial and microvascular
      dysfunction are independent predictors of ischemic cardiovascular events and long-term
      prognosis. The study´s objective is to evaluate the endothelial and peripheral
      microcirculation changes by venous occlusion plethysmography (VOP),
      nailfoldvideocapillaroscopy (NVC) and serum biomarkers in patients with myocardial ischemia
      detected by scintigraphy and normal coronarography.
    

Detailed description: 
      A cross-sectional study was carried out with 50 participants: 25 with myocardial ischemia
      detected by scintigraphy and normal coronarography (Ischemic Patient - IP) and 25 healthy
      non-ischemic individuals (Control Group - CG). All of them were submitted to anamnesis, serum
      markers (Intercellular Cell Adhesion Molecule [ICAM], Vascular Cell Adhesion Molecule[VCAM],
      adiponectin, endothelin, LDL-oxidized and CRP-US), NVC and VOP. Exclusion criteria were:
      inflammatory diseases, cancer patients, recent traumas, Diabetes Mellitus, obese individuals
      with BMI> 35 kg/m², uncontrolled hypertensive patients, and those with active infectious
      processes. In the NVC,capillary diameters were observed, as well as red blood cells velocity
      in the capillaries (RBCV, mm/s), maximum red blood cells after 1 minute ischemia (RBCVmax,
      mm/s) and time to reach maximal velocity (TRBCVmax) and, regarding VOP,the baseline blood
      flow (ml/min), post 5 minute ischemia flow and vascular resistance (mmHg/ml/min) were
      evaluated. Data were analyzed using Student's t-tests for independent or Mann-Whitney
      samples; χ2 or Fisher exact. The absolute and relative variations (delta) of plethysmography
      measurements versus baseline in each group were analyzed by the Wilcoxon signed-ranks test
      and compared between the groups by the Mann-Whitney test. For correction of confounding
      factors, age and BMI, it was used Covariance Analysis (ANCOVA).
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Fifty patients were studied: 39% male and 61% female. The mean age was 48 ± 15.8 years,
        being: 56.5 ± 10.5 years in the IP group and 39.4 ± 15.8 years in the CG. The mean BMI was
        26.5 ± 4.30 kg/m².
A Study of Benzathine Benzylpenicillin Intramuscular Injection in Japanese Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be an open label study to investigate the pharmacokinetics (PK) and safety of a
      single intramuscular injection of penicillin G benzathine in Japanese healthy subjects.
    


Intervention name(s): penicillin G benzathine
Intervention type(s): Drug
Intervention description(s): 2.4 million units (IM) of benzathine benzylpenicillin
Other intervention name(s): penicillin G; benzathine benzylpenicillin
Intervention MeSH terms: Penicillins; Penicillin G; Penicillin G Benzathine; Penicillin G Procaine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Benzathine benzylpenicillin; penicillin G benzathine
to Compare the Pharmacokinetics and Safety of Fimasartan/Rosuvastatin Combination Tablet and Coadministration of Fimasartan and Rosuvastatin
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase I clinical trial to compare the pharmacokinetics and safety of
      fimasartan/rosuvastatin combination tablet and coadministration of fimasartan and
      rosuvastatin in healthy male volunteers
    

Detailed description: 
      After subjects have signed informed consent voluntarily, they go through screening period for
      within 21 days.

      As period I, subjects of 1 Group take fimasartan and rosuvastatin at 1st day and subjects of
      2 Group take fimasartan/rosuvastatin combination at 1st day.

      And then, after wash out for 7 days, as period II, subjects of 1 Group take
      fimasartan/rosuvastatin combination at 8th day and subjects of 2 Group take fimasartan and
      rosuvastatin at 8th day.

      At each period, subjects of 1 Group have blood sampling 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5,
      4, 5, 6, 8, 12, 24, 48 and 72 hour after medication(17 times in each period, 34 times in
      total).

      At each period, subjects of 2 Group have blood sampling 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5,
      4, 5, 6, 8, 12, 24, 48 and 72 hour after medication(17 times in each period, 34 times in
      total).
    

Intervention name(s): Fimasartan; Rosuvastatin; Fimasartan/Rosuvastatin combination
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Fimasartan
Nano-Pulse Stimulation (NPS) in Seborrheic Keratosis Study
Condition: Lesion Skin; Seborrheic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis; Keratosis, Seborrheic
Study type: Interventional

Summary: 
      The primary purpose of this trial is to evaluate Nano-Pulse Stimulation (NPS) to clear or
      remove Seborrheic Keratosis (SK) lesions from off-facial areas of healthy adult subjects.
    

Detailed description: 
      Evaluate Nano-Pulse Stimulation (NPS) to clear or remove Seborrheic Keratosis (SK) lesions
      from off-facial areas of healthy adult subjects.

      The specific objectives of this study are to:

        -  Document the non-treated appearance of off-face SKs.

        -  Evaluate the clearance of SKs in off-face locations post-treatment versus pre-treated
           appearance of the same lesion.

        -  Evaluate the clearance of the treated SKs at various points in time over several weeks
           following the initial procedure, compared to the pre-treated SKs.
    

Intervention name(s): Nano-Pulse Stimulation (NPS)
Intervention type(s): Device
Intervention description(s): The Pulse generator delivers electrical pulses (nanosecond duration) that are applied directly to targeted lesion using sterile treatment tips with micro-needles.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Each subject served as their own control. Each subject had 4 lesions with 3 of the lesions serving in the Active Comparative Arm (Lesions treated with Nano-Pulse Stimulation) and 1 lesion serving as control not treated with Nano-Pulse Stimulation and assigned to No Intervention Arm.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nano-Pulse Stimulation; Seborrheic Keratosis
2B Active: Outpatient Rehabilitation for Adolescents With Chronic Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate whether a multimodal rehabilitation program
      effectively reduces functional disability in adolescents with chronic musculoskeletal pain,
      compared to care as usual.
    


Intervention name(s): Multimodal Rehabilitation Program; Care as Usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The Multimodal Rehabilitation Program is a Graded exposure based treatment. It consists of a Graded Exposure Module (GE), a Combination Module (HMGE) and a Parent Module (PM).; Care as usual is the care currently provided to adolescents with musculoskeletal chronic pain and is based on the principles of Graded Activity.
Other intervention name(s): MRP; CAU
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Pain; Adolescent; Graded Exposure
Kids + Adolescents Research Learning On Tablet Teaching Aachen
Condition: Chronic Inflammatory Intestinal Diseases (CED)
MeSH terms: Intestinal Diseases
Study type: Interventional

Summary: 
      The aim of this study plan is to implement a tablet quiz in the German-speaking area, in
      order to test the specific knowledge about chronic inflammatory intestinal diseases (CED)
      concerning pediatric patients in the context of an age-appropriated and interesting digital
      playing environment, and to process knowledge gaps at the subsequent doctor's contact. The
      quiz should be combined with a game and can be performed by the patients, while they wait in
      the ambulance for their doctor's appointment. The investigator's goals are to grasp playfully
      gaps in the CED knowledge regarding the patients and to use these in the following consulting
      hour for clarification and advice in line with a better understanding of the disease. With
      this, the specific knowledge, the understanding of the disease, the therapeutic adherence,
      and the self-efficacy should improve the self-responsible handling of the disease. In
      particular, the willingness of the group of older teenagers to transit into the adult
      medicine can be collected and processed. The investigators want to check the efficacy in a
      randomized, controlled study with two groups of 15 pediatric CED patients. The hypothesis is
      that the additional play of the tablet-CED-quiz and the individualized advice have a positive
      impact on the CED knowledge, the disease activity, the CED-related life quality and the
      willingness of teenagers for transition.
    


Intervention name(s): intervention group
Intervention type(s): Other
Intervention description(s): The CED patients play the tablet-CED-quiz, while they wait for their doctor's appointment, so that gaps in the CED knowledge can be clarified during the doctor's consultation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Life Satisfaction and Psychopathology in Institutionalized Elderly People
Condition: Anxiety Depression (Mild or Not Persistent)
MeSH terms: Depression
Study type: Interventional

Summary: 
      The present study attempted to test the benefits of a Mindfulness-Based Stress Reduction
      (MBSR) program in Portuguese institutionalized elderly people, as a way to improve life
      satisfaction and reduce psychopathology. The sample included 12 institutionalized elderly
      people, with ages between 65 and 91 (M = 82.58 years; SD = 7.87), that filled several
      selfreport questionnaires and were assessed with Mini Mental State Examination. Participants
      attended to an adapted Mindfulness-Based Stress Reduction program (KabatZinn,1994), with 48
      sessions (16 weeks) and Participants were evaluated before and after the intervention.
    


Intervention name(s): Mindfulness-Based Stress Reduction (MBSR) program
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Mindfulness; Elderly; Psychopathology
Investigation of the Effect of Stair Activity on Lumbal Paravertebral Mechanical Properties in Amputes.
Condition: Stair up and Down, Amputation; Amputation,Stair up and Down
Study type: Observational

Summary: 
      With the onset of prosthesis use following lower extremity amputations,body shows
      biomechanical changes according to the amputation level and consequently develops adaptation
      mechanisms both on the healthy and ampute side. Adaptations in the lumbo-pelvic and lower
      lumbar regions cause asymmetries in the muscle tissue by causing changes in the morphological
      structure of the muscle, especially in the muscles of the waist, hip and knee and
      recruitment.

      The aim of this study is to investigate the effect of stairing up and down activity on the
      mechanical properties of lumbal paravertebral muscles in TFA and TTA and its relation with
      lower lumbar region pain.
    


Intervention name(s): Group 1; Group 2
Intervention type(s): Other; Other
Intervention description(s): The patients will be asked to go up and down 9-step stair with the highest speed they can make.; The patients will be asked to go up and down 9-step stair with the highest speed they can make.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Unilateral transfemoral and transtibial amputate patients
AI Driven Biofeedback Wearable
Condition: Knee Injuries
MeSH terms: Knee Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to conduct a comprehensive clinical and biomechanical screening
      of high school, collegiate-level, recreational, and Olympic/professional-level athletes with
      the goal of identifying individual functional and performance deficits that lead to future
      injury.
    


Intervention name(s): Biofeedback Knee Sleeve; Sham Biofeedback
Intervention type(s): Device; Device
Intervention description(s): The biofeedback knee sleeve is a device that is artificially-intelligent and utilizes determined cut-off values of knee motion and forces to determine whether a motion is 'good' or 'bad'. A 'bad' knee motion will provide a haptic output to the wearer (biofeedback) so that they can take note of what the previous motion was that caused the device to signal a warning.; The biofeedback knee sleeve is a device that is artificially-intelligent and utilizes determined cut-off values of knee motion and forces to determine whether a motion is 'good' or 'bad'. This intervention will provide sham biofeedback during training sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: injury; prevention; biofeedback; knee; wearable; rehabilitation
Dose-finding Study to Evaluate Immunogenicity of Three Different Dose Levels of the IMVAMUNE (MVA-BN) Smallpox Vaccine.
Condition: Smallpox
MeSH terms: Smallpox
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the study is to find the optimal dose for the smallpox candidate vaccine
      IMVAMUNE (MVA-BN). For this purpose the study compares IMVAMUNE (MVA-BN) administered at
      three different dose levels.
    


Intervention name(s): IMVAMUNE (MVA-BN)
Intervention type(s): Biological
Intervention description(s): Two vaccinations of 0.5 ml MVA-BN vaccine, separated by a 4 week interval.
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention