bioihbjkbjnl/mcl2 huggingface dataset:
Galileo-Hip Whole Body Vibration /Conventional Physiotherapy /Coxarthrosis
Condition: Coxarthrosis
MeSH terms: Osteoarthritis, Hip
Study type: Interventional
Phase: Phase 4

Summary: 
      Osteoarthritis (OA) is the most common degenerative arthropathy. Load-bearing joints such as
      knee and hip are more often affected than spine or hands. The prevalence of gonarthrosis is
      generally higher than that of coxarthrosis.

      Because no cure for OA exists, the main emphasis of therapy is analgesic treatment through
      either mobility or medication. Non-pharmacologic treatment is the first step, followed by the
      addition of analgesic medication, and ultimately by surgery.

      The goal of non-pharmacologic and non-invasive therapy is to improve neuromuscular function,
      which in turn both prevents formation of and delays progression of OA. A modification of
      conventional physiotherapy, whole body vibration has been successfully employed for several
      years. Since its introduction, this therapy is in wide use at our facility not only for
      gonarthrosis, but also coxarthrosis and other diseases leading to muscular imbalance.
    

Detailed description: 
      This study is a randomized, therapy-controlled trial in a primary care setting at a
      university hospital. Patients presenting to our outpatient clinic with initial symptoms of
      coxarthrosis will be assessed against inclusion and exclusion criteria. After patient
      consent, 6 weeks of treatment will ensue. During the six weeks of treatment, patients will
      receive one of two treatments, conventional physiotherapy or whole-body-vibration exercises
      of one hour three times a week. Follow-up examinations will be performed immediately after
      treatment and after another 6 and 20 weeks, for a total study duration of 6 months. 20
      patients will be included in each therapy group.
    

Intervention name(s): Conventional physiotherapy
Intervention type(s): Other
Intervention description(s): Patients in this study group will attend physiotherapeutic exercise sessions of one hour three times a week for six weeks. The sessions consist of aerobic and muscle strengthening as well as coordination exercises. Patients will practice activities of daily living. The goals of these exercises are to improve joint stability, optimize knee and ankle proprioception, and advance neuromuscular innervation of the lower extremity and thereby suppress pathologic motion patterns. This should lead to optimized mobility, increased stability, and thus more endogenous analgesia of the affected joint
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hip, arthrosis
The Effects of Coffee Main Constituents (Caffeine and Chlorogenic Acid) Supplementation on Inflammatory, Metabolic Factors, Hepatic Steatosis and Fibrosis in None- Alcoholic Fatty Liver Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Nonalcoholic Fatty Liver
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to investigate the effects of coffee main constituents (caffeine
      and chlorogenic acid) supplements on inflammatory, metabolic factors, hepatic steatosis and
      fibrosis in none- alcoholic fatty liver patients with type 2 diabetes. Two hundred patients
      with fatty liver and type 2 diabetes will be randomly assigned to one of four groups: group
      1, caffeine (200 mg/d) plus chlorogenic acid (200 mg/d); group 2, caffeine (200 mg/d) plus
      placebo; group 3, chlorogenic acid (200 mg/d) plus placebo; group 4, placebo plus placebo.
      Supplementation will be daily and will supervise for 6 months.
    


Intervention name(s): caffeine and chlorogenic acid; caffeine; chlorogenic acid; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): caffeine plus chlorogenic acid; caffeine plus placebo; chlorogenic acid plus placebo; placebo plus placebo
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Preventive Arterial Wall Phenotype and Low-dose Fluvastatin/Valsartan Combination
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional

Summary: 
      The study was designed to test whether short-term treatment with a very low-dose combination
      of fluvastatin and valsartan could induce improvement of endothelial function, arterial
      stiffness, vascular inflammation, oxidative stress and expression of protective genes in
      subjects with moderate cardiovascular risk.
    

Detailed description: 
      The largest population that suffers from cardiovascular events are subjects at moderate
      cardiovascular risk. However, no effective and safe preventive treatment is available for
      this population. This study aimed to investigate whether their arterial wall phenotype could
      be turned to a preventive direction by low-dose fluvastatin/valsartan combination
      (low-flu/val).

      Twenty males at moderate cardiovascular risk (as classified by SCORE) were blindly randomised
      into the intervention group (n=10, low-flu/val: 10 mg/20mg) or control group (n=10, placebo).
      At inclusion and after 30 days of treatment, brachial flow-mediated dilatation (FMD), beta
      stiffness coefficient, carotid pulse wave velocity (c-PWV), carotid-femoral PWV, reactive
      hyperaemia index, high-sensitivity C-reactive protein (hs-CRP), interleukin 6, vascular cell
      adhesion molecule 1, total antioxidant status and expression of several protective genes
      (SIRT1, mTOR, NF-κB1, NFE2L2, PRKAA1) were followed.
    

Intervention name(s): fluvastatin 10 mg and valsartan 20 mg; placebo
Intervention type(s): Drug; Drug
Other intervention name(s): low-flu/val
Intervention MeSH terms: Valsartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: arterial stiffness; endothelial dysfunction; fluvastatin; valsartan; inflammatory markers; oxidative stress; SIRT1
The Effect of Exercises of Different Intensity Applied After Total Knee Arthroplasty on Exercise-Induced Hypoalgesia
Condition: Knee Osteoarthritis; Pain, Acute
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Acute Pain
Study type: Interventional

Summary: 
      The aim of this study was to investigate whether exercise-induced hypoalgesia (EIH) is
      present following exercise in patient after total knee arthroplasty (TKA) and if so, if it
      changes with exercise intensity. A repeated measures and single-blinded randomized study were
      done. Thirty-eight patients 24 hours after TKA were randomly assigned to either low intensity
      exercises (LIE) group or high intensity exercises (HIE) group. An exercise programs lasted
      for five days during the hospitalization period. Pain severity was assessed by Visual Analog
      Scale (VAS) (0-10 mm). Pressure pain thresholds (PPTs) were measured over quadriceps and
      biceps brachii and muscles immediately before and after exercise.
    

Detailed description: 
      Background: The aim of this study was to investigate whether exercise-induced hypoalgesia
      (EIH) is present following exercise in patient after total knee arthroplasty (TKA) and if so,
      if it changes with exercise intensity.

      Methods : A repeated measures and single-blinded randomized study were done. Thirty-eight
      patients 24 hours after TKA were randomly assigned to either low intensity exercises (LIE)
      group or high intensity exercises (HIE) group. An exercise programs lasted for five days
      during the hospitalization period. Pain severity was assessed by Visual Analog Scale (VAS)
      (0-10 mm). Pressure pain thresholds (PPTs) were measured over quadriceps and biceps brachii
      and muscles immediately before and after exercise.
    

Intervention name(s): High Intensity Exercises Program; Low Intensity Exercises Program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): HIE program consisted of ankle pump exercise, Quadriceps isometric exercise, Terminal extension exercise, Passive-active assistive-active range of motion exercise, Heel sliding exercise, Straight leg raise exercise. All exercises were performed for 3 sets of 15 repetitions.; LIE program: LIE program was similar to the HIE program. Main differences from the HIE program was repetitions of exercises. All exercises were performed by the patients for 2 sets of 8 repetitions and CPM sessions lasted each exercises session. LIE program took thirty minutes while HIE program lasted sixty minutes. Exercise intensity was monitored using the rating of perceived exertion (RPE) scale, maintaining a range between 6 and 20 RPE (16). PRE< 8 indicates low intensity, PRE>14 indicates high intensity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Total Knee Arthroplasty; Exercises intensity; pressure pain threshold; exercise-induced hypoalgesia
Effects of Game-based Balance Exercise for Older Adults With Fall History
Condition: Mobility Limitation
MeSH terms: Mobility Limitation
Study type: Interventional
Phase: Phase 2

Summary: 
      Due to the many problems associated with reduced balance and mobility, providing an effective
      and engaging rehabilitation regimen is essential to progress recovery from impairments and to
      help prevent further degradation of motor skills. The purpose was to examine effects of
      physical therapy based on the task-oriented approach delivered in an engaging, interactive
      video game paradigm. The intervention focused on performing targeted dynamic tasks, which
      included reactive balance controls and environmental interaction. Thirty community dwelling
      and ambulatory older adults attending the Day hospital for balance and mobility limitation
      treatment participated in this study. Participants were randomly assigned to either a control
      group or experimental group. The control group received the typical rehabilitation program
      provided at the Day Hospital, consisting of strengthening and balance exercises. The
      experimental group received a program of dynamic balance exercises coupled to video game
      play, using a centre of pressure (COP) position signal as the computer mouse. The tasks were
      performed while standing on a fixed floor surface with progression to a compliant sponge pad.
      Each group received 16 sessions, scheduled two per week, each lasting 45 minutes. Balance
      performance measures and spatial-temporal gait variables were obtained pre- and
      post-treatment Findings demonstrated significant improvements for both groups in balance
      performance scores post-treatment, and change scores were significantly greater in the
      experimental compared to control group. No significant treatment effect was observed in
      either group for the spatial-temporal gait variables. In conclusion dynamic balance exercises
      on fixed and compliant sponge surfaces were feasibly coupled to interactive game-based
      exercise. This in turn resulted in a greater improvement in dynamic standing balance control
      compared to the typical exercise program. However there was no transfer of effect to gait
      function.

      Key Words: Balance, Postural; Rehabilitation; Therapy, computer-assisted; Video Games; Center
      of Pressure.
    


Intervention name(s): game-based balance exercises
Intervention type(s): Behavioral
Intervention description(s): 16 sessions, scheduled two per week, each lasting 45 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Balance; Postural; Rehabilitation; Therapy; computer-assisted; Video Games; Center of Pressure
Supporting Parents of Young Children With Type 1 Diabetes in Closed-Loop System
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This study will examine the impact of a closed-loop insulin delivery system intervention on
      health and psychological outcomes in families with young children with Type 1 Diabetes (T1D).
    


Intervention name(s): Developmental & Technological Demands; Distress Reduction; Nutrition, Set Point, & C:I Ratio; Hypoglycemia management; Minimal Intervention
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Education and training related to use of CGM in this age group; Education and training on reducing distress; Education and training on how to use the HCL system to dose for different kinds of foods to improve glycemic control; Education and training on reducing worries of hypoglycemia; Minimal intervention to simulate standard care - serves as the control group
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: 670G; Hybrid closed-loop system; pediatric
Sunitinib as First-Line Therapy in Treating Patients With Locally Advanced Metastatic Papillary Renal Cell Cancer
Condition: Kidney Cancer
MeSH terms: Carcinoma, Renal Cell; Kidney Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Sunitinib may stop the growth of cancer cells by blocking some of the enzymes
      needed for cell growth and by blocking blood flow to the tumor.

      PURPOSE: This phase II trial is studying how well sunitinib works as first-line therapy in
      treating patients with locally advanced or metastatic papillary renal cell (kidney) cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine the objective tumor response rate in patients with locally advanced or
           metastatic papillary renal cell carcinoma treated with sunitinib malate.

      Secondary

        -  To evaluate the safety of this drug in these patients.

        -  To determine time-to-event variables of overall survival, time to disease progression,
           time to response, and duration of response in patients treated with this drug.

      OUTLINE: This is a multicenter study.

      Patients receive oral sunitinib malate once a day on days 1-28. Treatment repeats every 6
      weeks in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed at 28 days and then periodically
      thereafter.
    

Intervention name(s): sunitinib malate
Intervention type(s): Drug
Intervention MeSH terms: Sunitinib
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 1 papillary renal cell carcinoma; type 2 papillary renal cell carcinoma; stage IV renal cell cancer; stage III renal cell cancer
Intracervical Anesthesia and Pain Associated With Intrauterine Contraceptive Insertion
Condition: Pain, Acute; Anesthesia, Local; IUD Insertion Complication
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary aim of our study is to evaluate the effect of intracervical anesthesia on pain
      scores immediately following levonorgestrel-releasing intrauterine system (LNG-IUS) insertion
      in nulligravida women.
    

Detailed description: 
      No prophylactic pharmacological intervention has proven efficacy in relieving pain during or
      after the insertion of levonorgestrel-releasing intrauterine system (LNG-IUS), only in
      reducing pain associated with the tenaculum. It is known that the nulligravida women have 3
      times more chance of presenting moderate / severe pain associated to LNG-IUS placement. A
      previous study showed that injectable intracervical anesthesia reduced the risk of
      moderate/severe pain by 40%. However, the anesthetic dose was small (36 mg of lidocaine) and
      the study did not evaluate only nulligravida women which are potential candidates for most
      pain relief benefit. Thus, the primary aim of this study is to evaluate the effect of
      intracervical anesthesia on pain scores immediately following LNG-IUS insertion in
      nulligravida women.
    

Intervention name(s): Anesthesia; Dry-needling
Intervention type(s): Drug; Procedure
Intervention description(s): A 2% lidocaine without vasoconstrictor injection into the cervix; A placement of thin needle into the cervix without substance injection
Other intervention name(s): 2% lidocaine without vasoconstritor
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Nulligravida women will be block-randomized to one of three groups (intracervical anesthesia, intracervical dry needling or no intervention)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intrauterine contraception; Pain; Anesthesia; LNG-IUD; nulligravida
Electrode-Based Sensor for Non-Invasive Fetal Heart Rate Monitoring With Improved Reliability
Condition: Laboring Women With Ultrasound and FSE Monitoring
Study type: Observational

Summary: 
      The specific goal of the proposed research is to develop a reliable, non-invasive fetal and
      maternal heart rate and contraction monitor that is unaffected by obesity and requires less
      nursing intervention than the tocodynamometer and Doppler ultrasound.
    

Detailed description: 
      The majority of obstetric deliveries in the US undergo electronic monitoring and continuous
      uterine activity and fetal heart rate (FHR) monitoring is the standard of care. Typically,
      external transducers are employed, the reliability of which depends on their proper
      positioning, which may be disturbed by patient or fetal movement. The tocodynamometer (strain
      gauge, toco for short) provides frequency and timing of contractions, but requires
      transmission of tension from the uterus to the sensor. Fetal heart rate is acquired with an
      external Doppler ultrasound transducer. The reliability of this monitor depends on the
      ability to obtain a window to the fetal heart.

      In some patients, particularly the obese, the toco and ultrasound may fail to monitor
      consistently. In others both transducers require frequent repositioning by the nursing staff,
      and the Doppler may erroneously report maternal heart rate instead of fetal.

      The alternative uterine activity monitor is an intrauterine pressure catheter (IUPC), which
      is placed through the cervical os in the adequately dilated patient with ruptured membranes.
      While this monitor usually provides a more reliable signal than the toco, as well as
      quantitative information regarding intrauterine pressure, it is invasive and there is an
      increased risk of infection. The alternative FHR monitor is via fetal scalp electrode (FSE),
      which is applied transvaginally to the fetal presenting part, also requiring adequate
      cervical dilation and ruptured membranes. While the FSE usually provides a more reliable
      signal, it is similarly invasive and increases risk of infection.

      Maternal obesity (defined as BMI at presentation ≥ 30) is an ever-increasing problem in the
      US, and is even more prominent in the obstetric suite. Meanwhile, obese women have an
      increased risk for labor problems, infections and other complications. Noninvasive labor
      monitoring, while preferable to reduce the infection risk, is particularly unreliable in this
      population.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Laboring women in Labor and Delivery Ward
      
Keywords: Ultrasound; FSE; IUPC
Tolerability and Background Fluorescence of the MediBeacon Transdermal GFR Measurement System
Condition: Acute Kidney Injury
MeSH terms: Acute Kidney Injury
Study type: Interventional

Summary: 
      This study is designed to evaluate background fluorescence of participants of different ages,
      gender, and skin color. In addition, 48-hour tolerability of the sensor and adhesive will be
      evaluated.
    

Detailed description: 
      The MediBeacon Transdermal GFR Measurement System investigational is intended to measure the
      Glomerular Filtration Rate (GFR) in patients with normal or impaired renal function by
      noninvasively monitoring fluorescent light emission from an exogenous tracer agent (MB-102)
      over time. The device utilized in this study is the Brilliance device. Approximately 1 male
      and 1 female from each age cohort (18-50 years; 51+ years) and clustered Fitzpatrick Skin
      Scale groups (I-II [Light, pale white; white, fair]; III-IV [Medium, white to olive; olive,
      moderate brown]; and V-VI [Brown, dark brown; black, very dark brown to black]) will be
      recruited, for a total of 12 participants. Participants will have Brilliance device sensors
      placed on two locations on their skin, which will remain for 48 hours. The sensor location
      will be prepared through shaving and cleaning (as applicable), placed on the skin via
      standard single-use adhesive pads, and baseline measurements collected. Participants may
      undergo activities of daily living while measurements are being collected. Light pressure and
      other minor perturbations may be applied to the sensors to evaluate the effect on background
      fluorescence. Adverse events associated with sensor placement (such as skin irritations) will
      be recorded.
    

Intervention name(s): Brilliance device sensor
Intervention type(s): Device
Intervention description(s): Two separate sensors will be attached via standard, single-use adhesive pads to the left and right pectoralis major on each participant.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Glomerular Filtration Rate