bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Patient Counseling on Adolescent Hemophilia Patient Compliance With Bleeding Logs
Condition: Hemophilia A; Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B; Hemorrhage
Study type: Interventional

Summary: 
      The study will see if counselling adolescents with severe or moderate Hemophilia A or B
      results in increased compliance in the maintenance of bleeding logs.
    

Detailed description: 
      The study will see if counselling adolescents with severe or moderate Hemophilia A or B
      results in increased compliance in the maintenance of bleeding logs.To do this subjects will
      be randomized into a control group and a group who will receive consistent counselling by a
      pharmacist about their bleeding logs.

      The aims of the study are:

        -  To provide a new method of bleeding and treatment documentation in the home setting
           (logs) to adolescent subjects with Hemophilia A or B

        -  To counsel these subjects about adherence to their treatment regimen prescribed by
           physician and the importance of keeping accurate documentation of each bleeding episode
           and its treatment.

        -  To improve maintenance of logs, to allow for 1) assessment of bleeding frequency and
           treatment efficacy and 2) early detection of target joint bleeding and the potential
           need for prophylactic factor replacement.
    

Intervention name(s): Counseling; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients are contacted every two weeks after initial counseling to discuss the completion of bleeding records.; No more contacts are made with control patients after the initial counseling session.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Bleeding logs; Factor Infusions
Osteopathy Non-manipulative in Patients With Crohn's Disease.
Condition: Crohn´s Disease
MeSH terms: Crohn Disease
Study type: Interventional

Summary: 
      Crohn's disease (CD) is an inflammatory bowel disease with a high prevalence. Its etiology is
      unknown and is considered a multifactorial disease. It is known that the existence of a
      genetic factor, industrialization and development of the country and environmental factors
      have great influence on the appearance of intestinal pathology (the Val; Buderus; Molodecky).
      CD is a chronic inflammatory bowel disease localized throughout the course of the digestive
      tract (oral-anal). The aim of this study is to evaluate the effect of a treatment program
      combining technical nonmanipulative appropriate in affected patients (CD) to increase the
      overall quality of life and related EC, lower abdominal pain direct and indirect osteopathic
      soft, observe the sense of change after treatment, and psychological aspects.
    

Detailed description: 
      All of the participants were recruited, in a non-probabilistic way, from the Valencian
      Association of Enfermos de Crohn y Colitis Ulcerosa (ACCU) The participants were allocated to
      two different groups depending on their possibility of participation in the therapeutic
      sessions. The group that received the therapy was called experimental group (EG) and the
      group, who did not, control group (CG). The participants were allocated independently of
      their disease status (outbreak or remission).

      An experimental study carried out during a period of four weeks in order to explore the
      effect of the specific treatment on the following outcomes: global quality of life, quality
      of life in CD and pain.

      The participants, in the EG were treated in three sessions, that lasted 45 minutes, during
      the study duration (1 session each 9-10 days). The physiotherapist who applied the treatment
      had an extensive experience in manual therapy.

      Both groups come to laboratory two times for the assessment, one at the beginning of the
      study and the other one at the end. In each session several questionnaires were administered
      by a physiotherapist who was blinded to the group assignment.
    

Intervention name(s): Manual Therapy
Intervention type(s): Other
Intervention description(s): Non-manipulative treatment osteopathic techniques combined direct and indirect soft appropriate in patients with Crohn's disease
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pain; effectiveness; manual therapy
Glucose and Fructose Stimulated Brain Activity in Obese Subjects
Condition: Exploratory Behavior
Study type: Interventional

Summary: 
      The objective is to investigate neuro-anatomical correlates of the regulation of energy
      intake by means of functional MRI. Administration of glucose as well as fructose is followed
      by functional brain MRI, and findings are correlated with serum glucagon-like peptide 1
      (GLP-1) levels as an endogenous satiety signal in obese humans.
    


Intervention name(s): tap water; Glucose; Fructose
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 300ml tap water via nasogastric tube; 300ml tap water with 75g Glucose via nasogastric tube; 300ml tap water with 25g Fructose via nasogastric tube
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Study to Identify if Saie Beauty's Under Eye Concealer Works to Improve Under-Eye Skin Appearance and Reduce Imperfections
Condition: Wrinkle
Study type: Interventional

Summary: 
      Saie Beauty has developed 'Hydrabeam Sheer Brightening Under Eye Concealer' that is
      specifically designed for improving under-eye skin health. The concealer is aimed at
      improving under-eye skin features including hydration, firmness/elasticity, smoothness, and
      brightness. At the same time, it is aimed at reducing imperfections such as dark circles,
      skin redness, fine lines, wrinkles, and crow's feet. The aim is to understand and assess the
      efficacy of treatment from the participants' perspective and to see if the participants
      reported changes in skin features, dark circles, brightness, fine lines, wrinkles, crow's
      feet, and other skin imperfections.
    


Intervention name(s): Saie Beauty's Hydrabeam Sheer Brightening Under Eye Concealer
Intervention type(s): Dietary Supplement
Intervention description(s): Eye Concealer
Intervention model: Single Group Assignment
Intervention model description: This is an open-label single-group, non-randomized, non-controlled interventional treatment study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: skin aging; fine lines; crow's feet; dark circles
Web-Based Active Balance Childhood Study in Chinese-American
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      This study compares the feasibility and efficacy of an individually tailored, child-centered,
      Internet-based behavioral intervention with that of general Internet-based health information
      for improving health behaviors and relative weight in Chinese-American children during a
      6-month period. A total of 60 children (age 10-14) and their families will be randomized to
      either the intervention group or control group. The intervention is based on the Social
      Cognitive Theory and Transtheoretical Model.
    

Detailed description: 
      The proposed study will use a randomized experimental design to examine the effects of an
      individually tailored, Internet-based behavioral intervention program on improving health
      behavior (dietary intake and physical activity) and anthropometrics of Chinese-American
      children. A total of 60 children and their families will be recruited. The intervention will
      include a weekly Internet session tailored to each individual child for eight weeks and three
      Internet sessions for parents. Children and their parents in the control group will receive
      general health information on healthy eating, active lifestyles, dental care, smoking
      cessation, and risk taking issues via the Internet. The content of the sessions is described
      later. After informed consent is obtained from parents and verbal assent from the children,
      baseline data (T0) will be collected before assigning the children and parents to the
      intervention group or control group. Follow-up data for both groups will be collected at 2
      months (T1), 4 months (T2) and 6 months (T3) after baseline.
    

Intervention name(s): general health information; individually-tailored intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): participants received general health information; participants received individually-tailored intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: web based intervention; individually-tailored; Chinese-American children; compared the changes in physical activity level; changes in dietary intake; changes in coping strategy used; changes in BMI
Radiofrequency Ablation in Relieving Pain in Patients With Bones Metastases
Condition: Metastatic Cancer; Pain
MeSH terms: Neoplasm Metastasis
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells
      and may help to relieve pain caused by bone metastases.

      PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in relieving
      pain in patients who have bone metastases.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the efficacy of radiofrequency ablation, in terms of pain relief at 4 weeks,
           in patients with painful bone metastases.

        -  Determine the safety of this regimen in these patients.

        -  Compare the change in pain interference with daily life and analgesic use at 4 weeks vs
           baseline in patients treated with this regimen.

        -  Determine the time to recurrence of worst pain in patients treated with this regimen.

      OUTLINE: This is a multicenter study.

      Patients receive radiofrequency ablation (RFA) to targeted tumor(s) on day 0 (multiple tumors
      may receive ablation in multiple sessions). Patients who achieve a reduction in worst pain of
      at least 2 points within 4-8 weeks but experience recurring pain at the RFA site or are
      diagnosed with a new painful lesion within 4-24 weeks receive 1 additional treatment to the
      recurring or new site.

      Pain (using the Brief Pain Inventory scale of 0-10), analgesic use, and quality of life are
      assessed at baseline, on day 1, weekly for 4 weeks, and then every 2 weeks for 20 weeks.

      Patients are followed for 6 months beyond the last RFA treatment.

      PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study.
    

Intervention name(s): pain therapy; radiofrequency ablation
Intervention type(s): Procedure; Procedure
Primary purpose: Supportive Care
Keywords: bone metastases; pain
Protocols and Guidelines for the Use of Digital Twins in Frail Older People
Condition: Frail Elderly Syndrome
Study type: Interventional

Summary: 
      The Proto-Aging study aims to define experimental protocols and guidelines to enable the
      development of musculoskeletal models (digital twins) of elderly people, with the ultimate
      goal to comprehensively characterize frail elders from a biomechanical standpoint.

      It is typical for the elderly to present with weakness, slowed movements and reduced levels
      of physical activity, all of which may be related to the loss of muscle force (dynapenia).
      Unfortunately, to date, the primary cause for dynapenia is difficult to identify. Digital
      twins may help to this end, but their development remains critical as it requires a
      specialized skillset and experimental data for model personalisation.

      In this study, where the investigators will recruit a small group of frail elders and a
      cohort of healthy young individuals, all participants will undergo the following
      examinations: (i) gait assessment, (ii) maximal voluntary isometric contraction (MVIC) test,
      (iii) superimposed neuromuscular electrical stimulation, and (iv) full lower limb magnetic
      resonance imaging. Surface electromyography data will further be collected while the subjects
      perform both the gait assessment and the MVIC test. Last, clinical questionnaires will be
      administered, and the subjects will be asked to perform additional clinical measures (i.e.,
      hand-grip test, bioelectrical impedance analysis).

      At the end of the study, a reduced version of the experimental protocol will be developed,
      with the intent to provide clinicians with a protocol that can be deployed in clinical
      settings, accounting for the observed reliability and repeatability of each measure, the
      required level of expertise, and the associated costs and time expenditure.
    


Intervention name(s): Comprehensive Biomechanical assessment
Intervention type(s): Diagnostic Test
Intervention description(s): Magnetic resonance images, electromyography and dynamometry data will be used, together with data from the gait assessment and clinical questionnaires/measures, to characterize the biomechanics of the participants, and to develop and inform personalised musculoskeletal models
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Elderly; Frailty; Dynapenia; Muscle weakness; Maximal Voluntary Isometric Contraction; Superimposed Neuromuscular Electrical Stimulation; Dynamometry; Electromyography; Clinical questionnaires; Hand-grip test
Repetitive Transcranial Magnetic Stimulation in SCA3 Patients
Condition: Spinocerebellar Ataxia Type 3
MeSH terms: Ataxia; Spinocerebellar Ataxias; Spinocerebellar Degenerations; Machado-Joseph Disease
Study type: Interventional

Summary: 
      Machado-Joseph Disease (MJD) or spinocerebellar ataxia type 3 (SCA3) is the most common
      spinocerebellar ataxia worldwide.Repetitive transcranial magnetic stimulation (rTMS) is a
      form of brain stimulation therapy used to treat depression and cerebellar ataxias. In this
      randomized, double-blind, sham-controlled study, the investigators will evaluate whether a 15
      day treatment with 1 Hz of repetitive transcranial magnetic stimulation (rTMS) can improve
      symptoms (motor symptoms and non-motor symptoms) in patients with MJD.
    

Detailed description: 
      Machado-Joseph Disease (MJD) or spinocerebellar ataxia type 3 (SCA3) is the most common
      spinocerebellar ataxia worldwide. MJD shows remarked clinical heterogeneity and presents with
      various clinical manifestations, including cerebellar ataxia, limb incoordination,
      dysarthria, sleep disorders, axonal neuropathy, dystonia, pyramidal signs and, diplopia. No
      effective treatment is currently available for MJD.

      Repetitive transcranial magnetic stimulation (rTMS)enables non-invasive modulation of
      cortical excitability. rTMS targeting cerebellar structures is capable of inducing
      long-lasting changes in the excitability of cerebello-thalamocortical pathways.

      Subjects will be randomized in two groups, one receiving a consecutive 15-day treatment with
      1 Hz of repetitive transcranial magnetic stimulation and the other receiving sham stimulation
      with identical parameters. Patients will be clinically assessed at baseline, during
      intervention period at 7 days and 15 days immediate after treatment.
    

Intervention name(s): Active repetitive transcranial magnetic stimulation; Sham repetitive transcranial magnetic stimulation
Intervention type(s): Device; Device
Intervention description(s): Consecutive 15-day active treatment with 1 Hz of repetitive transcranial magnetic stimulation; Consecutive 15-day sham treatment with 1 Hz of repetitive transcranial magnetic stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Device:Active repetitive transcranial magnetic stimulation; Device:Sham repetitive transcranial magnetic stimulation
Treatment of Insomnia Secondary to Chronic Pain
Condition: Insomnia; Pain
MeSH terms: Sleep Initiation and Maintenance Disorders; Chronic Pain
Study type: Interventional

Summary: 
      Several studies have shown that behavioral therapy for chronic pain can be beneficial for
      chronic pain and that behavioral therapy for insomnia can be beneficial for insomnia.
      However, seldom do chronic pain patients with insomnia receive a behavioral treatment for
      insomnia. The purpose of this study is to evaluate whether treatment for insomnia is helpful
      for pain and whether treatment for pain is helpful for insomnia. It will also assess whether
      a combined treatment is any more or less effective for pain or for sleep. Finally, the study
      will assess whether any of these treatments leads to improvements in immune function.
    

Detailed description: 
      The investigators' primary goal is to assess the extent to which three forms of
      cognitive-behavioral treatment (CBT for insomnia, CBT for pain, and combined insomnia & pain)
      diminishes insomnia symptoms in patients with chronic pain compared to a group not receiving
      CBT. This will be evaluated in a randomized trial with before and after evaluations using
      standard sleep diary measures of sleep continuity.

      The investigators' secondary goal is to assess whether treatment responses to any of the
      interventions are associated with alterations in immune function.

      The investigators' tertiary goals are to evaluate whether improved sleep has effects on
      patient reports of pain severity, frequency, and tolerability as well as on mood and quality
      of life.
    

Intervention name(s): CBT for Insomnia (CBT-I); CBT for Pain (CBT-P)
Intervention type(s): Behavioral; Behavioral
Other intervention name(s): Cognitive-Behavioral Therapy for Insomnia (CBT-I); Cognitive-Behavioral Therapy for Pain (CBT-P)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Insomnia; Sleep; Pain; Pain, Chronic; Behavior Therapy; CBT; CBT-I; cognitive-behavioral
Gabapentin Premedication for ACL Reconstruction: RCT
Condition: Anterior Cruciate Ligament (ACL) Reconstruction
Study type: Observational

Summary: 
      This double blind randomized control trial will enroll 100 participants ages 12-18 years,
      undergoing ACL repair. Participants receive gabapentin or placebo preoperatively. Outcome
      measurements of self-reported pain score using scale of 1 to 10 with 10 being the worse
      obtained from the EMR and participants interviews with a phone nurse for five days
      postoperatively to determine severity of pain as well as use of opioids.
    

Detailed description: 
      Anterior Cruciate Ligament (ACL) injury and surgical repair occurs in 200,000 active
      adolescent and young adult patients each year. ACL repair is associated with significant
      postoperative pain. Current methodologies for pain include regional nerve blocks, opioid or
      non-steroidal analgesia. Few studies have evaluated use of neuro-inhibitors such as
      gabapentin to limit pain response.

      The purpose of this study then is to examine the use of gabapentin in reducing postoperative
      pain in adolescent ACL patients. The investigators hypothesize one 15mg/kg (up to 600mg) dose
      of gabapentin preoperatively would reduce: 1) self-reported postoperative pain and, 2) opioid
      use compared to patients who do not receive preoperative gabapentin.

      This double blind randomized control trial will enroll 100 participants ages 12-18 years,
      undergoing ACL repair. Participants receive gabapentin or placebo preoperatively. Outcome
      measurements of self-reported pain score using scale of 1 to 10 with 10 being the worse
      obtained from the EMR and participant interviews with a phone nurse for five days
      postoperatively to determine severity of pain as well as use of opioids.

      Outcome measurements will give a more comprehensive description of the postoperative
      experience and test gabapentin's opioid sparing effect. Due to paucity of literature on pain
      relief in this population, this pilot study will inform a larger multi-site study.
    

Intervention name(s): Gabapentin
Intervention type(s): Other
Other intervention name(s): Neurontin
Intervention MeSH terms: Gabapentin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Inclusion criteria include patients ages 12-18 years with an ASA class 1 or 2 scheduled for
        elective ACL reconstruction in the outpatient setting by Dr. Michael Busch. Exclusion
        criteria include a BMI >40, recurrent ACL reconstruction, allograft ACL reconstruction,
        history of renal insufficiency, chronic pain or allergy to gabapentin.
Artificial Sweeteners in Breast Milk
Condition: Breastfeeding; Diabetes Mellitus; Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This study will investigate how some artificial sweeteners (AS) cross from blood to
      breastmilk in breastfeeding women after oral intake. Moreover, it will be investigated
      whether the kinetics of AS differ based on the women's body composition (BMI) and metabolic
      status (diabetes). This will be investigated through a clinical trial in which 60 women
      divided into three groups (normal weight, overweight and diabetic) will drink a beverage
      containing four AS. over a period of six hours the women will donate blood and breast milk
      samples in order to investigate the presence of AS.
    


Intervention name(s): Artificial sweeteners (acesulfame-potassium, sucralose, saccharine, cyclamate)
Intervention type(s): Dietary Supplement
Intervention description(s): The intervention is found in light products ingested by millions of people on a daily basis worldwide
Intervention model: Single Group Assignment
Intervention model description: 60 women will be divided into three groups (n=20 each) based on pre-pregnancy BMI and metabolic status.
The groups are
Normal weight (BMI < 25),
Over weight (BMI > 27),
Diabetic
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Artificial sweeteners; Non-nutritive sweeteners
A Multi-Center Trial to Compare Three Doses of Meloxicam and Placebo in Patients With Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      A 12-week trial consisting of 5 visits (6 if follow up is needed) to find out how effective
      and safe three different doses of meloxicam are compared with placebo in Rheumatoid
      Arthritis. Patient will take one dose of study medication daily.
    


Intervention name(s): Meloxicam
Intervention type(s): Drug
Intervention MeSH terms: Meloxicam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double