bioihbjkbjnl/mcl2 huggingface dataset:
Pain and Symptom Management in Rural Communities
Condition: Chronic Pain; Palliative Care
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      Patients in isolated rural settings often lack easy access to pain care and specialist
      services. Yet rural residents are more likely than their urban counterparts to be older; be
      in poorer overall health; suffer from more chronic or serious illnesses and disabilities; be
      uninsured or underinsured; and live in poverty. Telehealth is an emerging method of health
      care delivery that has been found useful and effective in many clinical settings and
      specialties. Telehealth technologies can bridge geographic distance and increase access to
      specialist care in rural settings. The investigators propose a cluster randomized clinical
      trial design to test the effects of a telehealth-enhanced palliative care pain-management
      program for 240 patients and 40 providers in rural health care settings. The proposed program
      will provide services to both patients and providers: Patients will conduct self-assessments
      and report pain and other symptoms via telehealth. Health care providers will receive
      telehealth-delivered case consultations that will include case management, evidence-based
      practice resources, and peer support. Providers and their patients will be randomly assigned
      to intervention groups, which receive the telehealth-enhanced palliative care pain-management
      intervention, or to control groups. The investigators primary aim is to compare patient
      self-reports of pain and quality of life in the intervention and control groups over 2
      months. Aim 2 is to examine, in the intervention and control groups over 2 months, providers'
      knowledge and attitudes regarding pain and perceived competence in treating pain. Aim 3 is to
      evaluate the cost-effectiveness of the telehealth intervention. The investigators will use
      mixed effects models with patients nested within providers to evaluate the effect of the
      intervention on study outcomes. Findings from this study will be instrumental in advancing
      telehealth and improving pain management and palliative care among underserved rural
      populations.
    


Intervention name(s): telehealth enhanced pain management
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: pain and symptom management
Proof of Concept Study to Investigate the Recurrence of Acne Post Isotretinoin
Condition: Acne
MeSH terms: Recurrence
Study type: Interventional
Phase: Phase 4

Summary: 
      The use of topical retinoids is a mainstay and basis of early acne treatment to prevent the
      progression to inflammatory lesions. Post oral isotretinoin, it is not uncommon for
      non-inflammatory papules and comedones to recur. However, there has been no formal study to
      look at the prevention of recurrence of these acne lesions post isotretinoin in a long term
      basis. This may enhance the therapeutic options for post isotretinoin patients in order to
      prevent recurrence of their disease.

      Hypothesis Tretinoin microsphere 0.04% will prevent recurrence of acne lesions.
    

Detailed description: 
      Subjects will be randomized 1:1 to study product or vehicle. Subjects will be randomly
      assigned to each group by an unblinded dispenser.

      The study duration will be 24 weeks with visits at baseline (week 0), week 4, week 8, week 16
      and week 24. All study products will be administered once daily for 24 weeks. Subjects will
      apply a sufficient amount of study product to cover the entire face.
    

Intervention name(s): tretinoin microsphere 0.04% gel; vehicle gel
Intervention type(s): Drug; Drug
Intervention description(s): Applied daily to entire face for six months; Placebo
Other intervention name(s): Retin A micro 0.04%
Intervention MeSH terms: Tretinoin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: acne; tretinoin; isotretinoin; recurrence; Retin A micro
Evaluation of Indocyanine Green-guided Systematic Pelvic Lymphadenectomy in Endometrial and Cervical Cancer
Condition: Endometrial Cancer; Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms; Endometrial Neoplasms
Study type: Observational

Summary: 
      The lymph nodes involvement is one of the most important prognostic factors in endometrial
      (EC) and cervical cancer (CC). Indeed, the lymph node involvement in cancer patients modifies
      the International Federation of Gynecology and Obstetrics (FIGO) stage and plays a pivotal
      role in the choice of the adjuvant therapy.

      Since the modern imaging techniques are not yet able to accurately detect lymph nodes
      metastasis, pelvic systematic lymphadenectomy has still an important role and it still
      represents the gold standard in EC and CC. The sentinel lymph node (SLN) biopsy, which is a
      standard practice in breast cancer and melanoma, is often used in some early stage
      gynaecological cancers such as EC and CC.

      Indocyanine green (ICG) is the most used tracer for the detection of SLN in gynaecological
      cancer, especially in laparoendoscopic setting. ICG allows a complete visualization of the
      lymphatic drainage and, for this reason, it may be used even in systematic pelvic
      lymphadenectomy to guide the surgeon during the procedure. Several studies have demonstrated
      an advantage of the ICG-guided lymphadenectomy in other types of cancers, showing a higher
      number of lymph nodes removed with this technique when compared to standard lymphadenectomy
      (without ICG).

      To date, there is no published study about ICG-guided systematic pelvic lymphadenectomy in EC
      and CC. In this scenario, the aim of this study will be to compare systematic ICG-guided
      pelvic lymphadenectomy and standard lymphadenectomy in EC and CC.
    


Intervention name(s): Indocyanine green-guided systematic pelvic lymphadenectomy
Intervention type(s): Procedure
Intervention description(s): Injection of Indocyanine green within the uterine cervix before to perform laparoscopic/robotic systematic pelvic lymphadenectomy
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women affected by endometrial or cervical cancer undergoing laparoscopic/robotic systematic
        pelvic lymphadenectomy (with or without previous injection of indocyanine green tracer
        within the uterine cervix).
      
Keywords: Indocyanine green; Pelvic lymphadenectomy
Safety and Immune Response to an Investigational Dengue Type 2 Vaccine
Condition: Dengue Virus
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      Dengue viruses can cause dengue fever and other serious health conditions, primarily
      affecting people living in tropical regions of the world. This study will test whether a
      vaccine developed to prevent infection with dengue virus type 2 causes a response in people's
      immune system and is safe.
    

Detailed description: 
      Dengue viruses cause approximately 50 million cases of dengue fever and 1.5 million cases of
      the more severe diseases dengue hemorrhagic fever (DHS) and dengue shock syndrome (DSS) every
      year. There are four subtypes of the virus, and infection with one offers no protection from
      infection by the others. In fact, most cases of DHS and DSS occur in people infected by more
      than one subtype. In areas of the world where multiple subtypes of dengue are common,
      vaccines must be developed against each of the subtypes of dengue virus. This study will
      examine the safety and immune response of an investigational vaccine for preventing dengue
      virus type 2.

      Participation in this study will last about 6 weeks. Participants will be randomly assigned
      to be injected with either the investigational study vaccine or a placebo. Participants will
      have a five in six chance of receiving the vaccine. The first study visit will take place on
      the vaccination day, on which participants will undergo a physical examination, blood draw,
      and pregnancy test and then receive the vaccine. Participants will be given a thermometer and
      temperature card and be told to record their temperatures three times per day for 16 days
      after vaccination. Participants will come to follow-up visits every other day for the 16 days
      after vaccination and then 3, 4, and 6 weeks after vaccination (Days 21, 28, and 42).
      Assessments completed during these visits will include a questionnaire about how the
      participant is feeling, pregnancy test, review of temperature cards, blood draw, and physical
      exam. Blood drawn will be analyzed to check participants' health, determine the amount of
      vaccine and antibodies in the blood, test markers in white blood cells and genes, and look
      for proteins that are important for fighting dengue infection.
    

Intervention name(s): Investigational Vaccine for Dengue Virus Subtype 2; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Subcutaneous injection in upper arm of vaccine at dose of 10 plaque-forming units (PFU); Subcutaneous injection of placebo
Other intervention name(s): rDEN2/4Δ30
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vaccine; Dengue Hemorrhagic Fever
Aneurysms and Carotid Artery Block in Newborns
Condition: Cerebrovascular Disorder
MeSH terms: Cerebrovascular Disorders
Study type: Observational

Summary: 
      This study will determine the risk of brain aneurysm (abnormal outpouching of a brain artery)
      in young adults who had their carotid artery tied off as an infant as part of the
      extracorporeal membrane oxygenation (ECMO) procedure. This procedure is sometimes performed
      on newborns with lung problems so that they can have oxygen brought to their blood outside
      the body. ECMO operates similar to a heart-lung machine. Blood drained from the veins has the
      carbon dioxide removed and oxygen added. The oxygenated blood is then returned to the body
      through the arteries.

      People 18 to 25 years of age who underwent ECMO as an infant at the Children's National
      Medical Center in Washington, D.C., may be eligible for this study.

      Participants undergo the following procedures:

        -  Medical history and physical and neurological examinations.

        -  Magnetic resonance imaging (MRI) of the head and neck. MRI uses a strong magnetic field
           and radio waves to obtain images of body organs and tissues. The subject lies in the
           scanner (a metal cylinder surrounded by a magnetic field) for about 90 minutes, lying
           still for up to 15 minutes at a time. During part of the procedure, a contrast dye is
           injected into a vein through a catheter (thin plastic tube) to enhance the images.
    

Detailed description: 
      Objective:

      To assess whether the hemodynamic stress of long-term common carotid artery occlusion can
      lead to cerebral aneurysm formation in young adults.

      Study population:

      100 adults 18-25 years of age who underwent common carotid artery (CCA) occlusion as a
      neonate as part of the extracorporeal membrane oxygenation (ECMO) procedure performed in the
      setting of pulmonary insufficiency.

      Design:

      Patients who underwent CCA occlusion as a neonate for ECMO at Children's National Medical
      Center will be identified and contacted. The study will be explained and informed consent
      will be obtained. Subjects will undergo outpatient evaluation to include history and
      physical, magnetic resonance angiography and magnetic resonance imaging of the head.

      Outcome measures:

        -  Cerebrovascular anatomic anomalies such as cerebral aneurysms and persistent fetal
           circulation pathways, etc.

        -  Cerebral perfusion asymmetry on MRI.

        -  Cerebral parenchymal abnormalities such as stroke.
    

Time perspective: Retrospective
Keywords: ECMO; Cerebral Perfusion; Carotid Artery; Aneurysm; Cerebral Circulation; Common Carotid Artery Occlusion
Interaction Between Fosamprenavir/Ritonavir and a Single-dose Olanzapine (FORZA)
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The effect of fosamprenavir/ritonavir (steady state) on the pharmacokinetics of a single dose
      of olanzapine will be studied.

      In this study, the investigators expect an inducible effect of fosamprenavir/ritonavir on the
      CYP1A2 and UGT metabolism of olanzapine.
    

Detailed description: 
      Psychosis and other mental illnesses are commonly described in patients infected with the
      human immunodeficiency virus (HIV). New-onset psychosis is estimated to occur in up to 15% of
      patients infected with HIV while 5 to 7% of patients with HIV-infection suffer from
      pre-existing mental illnesses including schizophrenia. Olanzapine could be an attractive
      antipsychotic in HIV/AIDS patients with schizophrenia.

      Because olanzapine is a substrate for both UGT and CYP1A2, the pharmacokinetics of olanzapine
      might be influenced by low-dose ritonavir in combination with fosamprenavir. The current
      study is designed to test this hypothesis. Furthermore, in this study we evaluate the safety
      of such combination.
    

Intervention name(s): fosamprenavir/ritonavir; olanzapine; olanzapine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 16 days 700mg/100mg RTV BID; 15 mg olanzapine single dose; 10 mg olanzapine single dose
Intervention MeSH terms: Ritonavir; Fosamprenavir; Olanzapine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV infection; interaction; pharmacokinetics
A Safety and Efficacy Study of Golimumab (CNTO 148) in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of golimumab in
      patients with active rheumatoid arthritis despite Methotrexate therapy. Another objective is
      to evaluate the pharmacokinetics of golimumab.
    

Detailed description: 
      This clinical study is scheduled to be performed for the purpose of evaluating the safety and
      effectiveness of golimumab (CNTO148) administered in combination with stable dose
      (6-8mg/week) of methotrexate (MTX) to patients with rheumatoid arthritis (RA). CNTO148 50 mg
      group: CNTO148 50 mg SC injections every 4 weeks from the first administration until week
      152. If early escape, 100 mg SC injections every 4 weeks from week 16 until week 152. CNTO148
      100 mg group: CNTO148 100 mg SC injections every 4 weeks from the first administration until
      week 152 whether early escape or not Placebo group: Placebo SC injections every 4 weeks from
      the first administration until week 20 and then CNTO148 50mg SC injections every 4 weeks from
      week 16 until week 152
    

Intervention name(s): CNTO 148; Placebo; Methotrexate (MTX)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 50 mg or 100 mg given as a subcutaneous (under the skin) injection once every 4 weeks up to Week 152.; Placebo identical in appearance to CNTO 148 given as a subcutaneous (under the skin) injection once every 4 weeks up to Week 24.; 6 mg/week to 8 mg/week taken orally (by mouth) from at least 4 weeks before the initial investigational treatment to the completion of assessment at Week 52.
Other intervention name(s): Golimumab
Intervention MeSH terms: Golimumab; Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Rheumatoid arthritis; Fully Human anti-TNFa monoclonal antibody; CNTO148; Golimumab
Active Nutrition Program on Weight Loss
Condition: Weight Loss
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

Summary: 
      The study will evaluate the impact of the Active Nutrition 60-day program from USANA on
      weight loss and related measures, such as body composition, physical appearance/body shape,
      perceived wellness, and biochemical markers of health (e.g., blood lipids, glucose, insulin).
    

Detailed description: 
      To date, no controlled study exists to evaluate the impact of the Active Nutrition program
      from USANA on weight loss and related measures, such as body composition, physical
      appearance/body shape, perceived wellness, and biochemical markers of health (e.g., blood
      lipids, glucose, insulin). Therefore, the purpose of the proposed study is to evaluate the
      Active Nutrition weight loss program on body weight and related variables in a sample of
      overweight and obese men and women. Subjects in the Active Nutrition group will be compared
      to a control group of men and women following their standard diet, for a period of 60 days.
    

Intervention name(s): meal replacements and supplements
Intervention type(s): Dietary Supplement
Intervention description(s): Consumed daily: 2 Nutrimeal Active meal replacement shake, 1 electrolyte replacement drink, 3 metabolism + supplements, 1 whole food meal, and whole food snacks consisting of fruits and vegetables. 1200-1600 calories per day
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Experimental randomly assigned unblinded
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Active Nutrition
Scalp Pruritus Measurement Using Visual Analog Scale and 5-d Itch Scale in Children With Pediculosis Capitis
Condition: Pediculus Capitis; Pruritus
MeSH terms: Lice Infestations; Pruritus
Study type: Observational

Summary: 
      Pediculosis capitis is a parasitic infestation that can cause scalp pruritus and quality of
      life disturbances. There are two objective measurement for pruritus, visual analog scale
      (VAS) and 5-D itch scale, which can assess the severity of the scalp pruritus and the latter
      can also asses the quality of life affected by pruritus. Even though VAS can not be used to
      evaluate the impact of pruritus on quality of life, it is very easy to use while 5-D itch
      scale is complex and not child-friendly.

      The aim of this study is to determine the relationship between two different pruritus scales
      and to establish validity of pruritus VAS scale in evaluating quality of life in children
      with pediculosis capitis. We compare two pruritus scale on students with pediculosis of two
      boarding school in Bogor, West Java, Indonesia.
    

Detailed description: 
      This study used cross sectional design study.

      Subjects with eligible criteria were included and informed consent from the parents or legal
      guardian were obtained.

      The diagnosis of pediculosis capitis was made based on the findings of eggs, larva, or an
      adult parasite on the scalp or in the hair of the students. All subjects were asked for both
      VAS and 5-D itch scale.The VAS is categorized into five groups based on the point, as
      follows: 0 for no pruritus, <3 for mild pruritus, ≥ 3 - <7 for moderate pruritus, ≥ 7 - <9
      for severe pruritus, and ≥ 9 for very severe pruritus. The 5-D itch scale consists of five
      parameters: duration, degree, direction, disability (sleep, leisure/social activities,
      housework/errands, work/school), and distribution of the pruritus with points ranging from
      one to five.

      Data were recorded for statistical analysis, a chi-square test was used to determine the
      relationship between two categorical variables. The correlation coefficient between the VAS
      and 5-D itch scale was calculated using Spearman's rank correlation
    

Intervention name(s): VAS and 5-D itch pruritus assessment
Intervention type(s): Other
Intervention description(s): All subjects were evaluated for presence of pruritus using VAS and 5-D itch scale
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects with pediculosis capitis
      
Keywords: Pediculosis capitis; Scalp pruritus; VAS scale; 5-D itch scale; Quality of life
Task-oriented Upper Limb Training in MS
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      An adequate upper limb function is crucial to independently perform Activities of Daily
      Living (ADL). Persons with neurological diseases often experience upper limb dysfunction.
      Upper limb function in Multiple Sclerosis (MS) is highly prevalent, increasing with overall
      disability level, while the detrimental impact on ADL is higher than in stroke, given that
      symptoms often occur bilaterally. In contrast to stroke, it is unknown whether similar
      rehabilitation principles and effect sizes apply in MS given that this progressive
      neurodegenerative disease is characterized by multiple lesions and atrophy of brain
      structures. To date, optimal therapy dosage of upper limb rehabilitation programs are not
      known in the MS literature neither were characteristics of responders identified.

      The aim of this explorative study is to investigate the intensity dependent clinical effects
      of a task-oriented upper limb training in persons with MS with different upper limb
      disability levels.
    


Intervention name(s): Task-oriented upper limb training; Control intervention
Intervention type(s): Other; Other
Intervention description(s): Participants in the experimental groups (high-intensity and low-intensity) receive for 8 weeks, 60 min/day, 5 days/week a task-oriented upper limb rehabilitation training at a high or low intensity, respectively, instead of their regular occupational therapy hours provided in the conventional multidisciplinary rehabilitation program.
The task-oriented training involves practicing of functional daily tasks, with the intention to acquire or reacquire a skill. Most functional upper limb tasks require following essential movement components: reaching, moving, positioning, transporting, lifting the upper limb and/or an object and grasping, releasing, stabilizing, manipulating an object.
The Tagtrainer of SymbioTherapy is used to support the independent training of tasks with real objects with different sizes and weights. The Diego of Tyromotion is used in patients who require assistance (gravity support) during the performance of different upper limb tasks.; The participants in the control group receive for 8 weeks the conventional multidisciplinary rehabilitation program (physiotherapy, occupational therapy and speech or cognitive therapy if needed).
The training sessions are scheduled for 60 min/day, 5 days/week for the duration of 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Upper limb rehabilitation