bioihbjkbjnl/mcl2 huggingface dataset:
PET Imaging of Peripheral Benzodiazepine Receptors in Patients With Neurocysticercosis Using [C-11]PBR28
Condition: Neurocysticercosis; Healthy
MeSH terms: Neurocysticercosis; Cysticercosis; Taeniasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this protocol is to measure peripheral benzodiazepine receptors in the brain
      using positron emission tomography (PET) and compare the imaging results between patients and
      healthy people.
    

Detailed description: 
      Objective

      In endemic regions neurocysticercosis is the most common cause of adult acquired epilepsy and
      thus an important public health problem. The disease is caused by infection with the larval
      form of the tapeworm, Taenia solium. Although neurocysticercosis is common only in many
      developing regions, an increased number of patients are diagnosed in developed countries
      mostly due to immigration of infected individuals.

      The peripheral benzodiazepine receptor (PBR) can be a clinically useful marker to detect
      neuroinflammation because activated microglia in inflammatory areas expresses much greater
      levels of PBR than in microglia in resting conditions. PBR has been imaged with positron
      emission tomography (PET) using [(11)C]1-(2-chlorophenyl-N-methylpropyl)-3-isoquinoline
      carboxamide (PK11195), which provides low levels of specific signal. Recently we developed a
      new ligand, [(11)C]N-acetyl-N-(2-methoxybenzyl)-2-phenoxy-5-pyridinamine (PBR28), which
      showed much greater specific signal than [(11)C]PK11195 in non-human primates.

      The major objective of this protocol is to assess the utility of [(11)C]PBR28 PET to detect
      neuroinflammation in patients with neurocysticercosis.

      Study population

      Thirty patients will be recruited and clinically followed under protocol 85-I-0127, Treatment
      of Cysticercosis including Neurocysticercosis with Praziquantel or Albendazole, (PI: Theodore
      E. Nash, MD, NIAID). Thirty healthy subjects will be recruited.

      Design

      Fifteen patients with neurocysticercosis and the first 15 age-matched healthy subjects will
      have brain PET scans. Patients will have up to three [(11)C]PBR28 PET scans during the
      follow-up and the treatment under 85-I-0127, typically a few weeks apart.

      Outcome measures

      PBR28 binding will be compared with clinical symptoms and MRI findings. In addition, the
      binding will be compared between patients and age-matched control subjects because the high
      levels of specific binding may allow detection of an increase of PBR in regions where MRI
      does not detect inflammation.
    

Intervention name(s): [C-11]PBR28
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Epilepsy; Taenia Solium; Microglia; Neuroinflammation; Compartment Model; Neurocysticercosis; Healthy Volunteer; HV
THA Kinematics and Sound for Subjects for Normal, Diseased and Implanted Hips
Condition: Hip Injuries
MeSH terms: Hip Injuries
Study type: Observational

Summary: 
      The objective of this study is to analyze subjects having a normal hip and compare the in
      vivo kinematics to subjects requiring a total hip arthroplasty (THA) due to having a diseased
      hip and then later post-operative to their implanted hip. Ten subjects will have a normal
      hip, ten hips will be diseased, requiring a THA and then those ten diseased hips will be
      re-analyzed at least six months post-operatively after implantation of a THA.
    


Intervention name(s): DePuy Synthes total hip arthroplasty; Computer tomography; Fluoroscopy surveillance
Intervention type(s): Device; Radiation; Radiation
Intervention description(s): Computer tomography (CT) scan of the hip for creation of bone models.; Fluoroscopy evaluation of the hip during gait (level walking), chair rise, and ramp ascent and descent activities. Sound/vibration data will be collected simultaneously via non-invasive sensors attached to the hip joint.
Other intervention name(s): DePuy Synthes Summit/Pinnacle THA; DePuy Synthes Corail/Pinnacle THA
Intervention MeSH terms: Tacrine
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects with a diseased hip that requires THA. OR Subjects with a normal hip.
      
Keywords: total hip arthroplasty
Effects of Scapular Stabilization Versus Thoracic Spine Extension Exercises in Mechanical Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Mechanical neck pain is posteriorly occurring non-specific pain that originates from the
      superior nuchal line and extends to the first thoracic vertebrae. It is exacerbated by
      sustained neck postures, neck movements or cervical muscle palpation. The aim of study will
      be to compare the effects of scapular stabilization versus thoracic spine extension exercises
      on pain, disability and range of motion in patients with mechanical neck pain.
    

Detailed description: 
      A Randomized Clinical Trial will be conducted at Riphah Clinic Lahore, FMH Physiotherapy
      Clinic and Boston Physiotherapy Clinic Lahore through consecutive sampling technique on 30
      patients which will be allocated using simple random sampling through sealed opaque enveloped
      into Group A and Group B. Group A will be treated with scapular stabilization exercises and
      Group B will be treated with thoracic extension exercises at the frequency of 2 sets with 10
      repetitions and thrice a week. Outcome measures will be conducted through pain, disability
      and range of motion questionnaire after 6 weeks. Data will be analyzed during SPSS software
      version 21. After assessing normality of data by Shapiro-Wilk test, it will be decided either
      parametric or non-parametric test will be used within a group or between two groups.
    

Intervention name(s): scapular stabilization; Thoracic extension exercises
Intervention type(s): Other; Other
Intervention description(s): Scapular stabilization exercise aims to restore scapular position, orientations, motor control of muscles, and movement pattern, thereby attaining stability of scapula for better kinematics of shoulder.scapular stabilization exercises for 4 weeks with 2 sets of 10 repetitions. These exercises comprised of four exercise programs (Scapular retraction; Scapular mobilization, Scapular dynamic stabilization I and Scapular dynamic stabilization II); Thoracic extension involves concurrent posterior rotation (external torsion) and depression of the posterior ribs with elevation of the anterior ribs. Bending to the side is a combination of spinal segments side bending, ribs on the same come together while ribs on the opposite side separate.Group B performed thoracic extension exercises for 4 weeks with 2 sets of 10 repetitions. These exercises comprised of three exercise programs.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Disability Physical; muscle strength; range of motion
Mutations, Hormone Therapy (HRT) and Venous Thromboembolism
Condition: Cardiovascular Diseases; Venous Thromboembolism; Postmenopause
MeSH terms: Cardiovascular Diseases; Thromboembolism; Venous Thromboembolism
Study type: Observational

Summary: 
      To assess the interaction between hormone replacement therapy and the prothrombotic
      mutations, Factor V Leiden and the recently described prothrombin mutation (20210A) on the
      incidence of venous thromboembolism (VTE) in a population-based case-control study conducted
      at Group Health Cooperative of Puget Sound (GHC).
    

Detailed description: 
      BACKGROUND:

      Epidemiologic studies have identified Factor V Leiden as the most common cause of heritable
      thrombophilia, a prothrombotic mutation associated with a 5 to 7-fold increase in the risk of
      venous thromboembolism (VTE). In pre-menopausal women, the use of oral contraceptives is
      associated with a 4-fold increase in VTE risk, and the joint effects of oral contraceptive
      use and Factor V Leiden carriership increase the VTE risk of by a factor of 35. Recently, the
      results of several observational studies and randomized clinical trials suggest that in
      post-menopausal women, the use of hormone replacement therapy is associated with a 3-fold
      increase in VTE risk. Whether post-menopausal women with prothrombotic mutations experience a
      similar 20-fold increase in risk when they take post-menopausal hormones remains unknown.

      DESIGN NARRATIVE:

      In this case-control study, post-menopausal women with a first episode of objectively
      confirmed venous thromboembolism, and population-based controls were identified and recruited
      from the GHC enrollment files. Controls were frequency matched to the cases on age and
      calendar-year. Data collection included a review of ambulatory medical record and a telephone
      interview. The GHC computerized pharmacy database was used to assess exposure to hormone
      replacement therapy. A venous blood specimen was obtained from consenting subjects, processed
      into aliquots of white cells, plasma, and red cells, and stored at 70 degrees C prior to
      laboratory analysis. DNA was extracted from white cells, and molecular genotyping assays were
      conducted to assess carriership of prothrombotic mutations.
A Phase 1, Single-Ascending-Dose, Safety, Tolerability, Pharmacokinetic(PK), and Pharmacodynamic(PD) Study of BIIB068 in Healthy Participants
Condition: Systemic Lupos Erythematosus, SLE
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the safety and tolerability of single oral
      doses of BIIB068 in healthy participants. Secondary objectives are to characterize the
      single-oral-dose Pharmacokinetic (PK) of BIIB068 in healthy participants, to determine the
      effect of food on the single-oral-dose PK of BIIB068 in healthy participants and to examine
      the effect of administration of the proton pump inhibitor (PPI) esomeprazole on the
      single-dose PK of BIIB068 in healthy participants.
    


Intervention name(s): BIIB068; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered as specified in the treatment arm.; Administered as specified in the treatment arm
Other intervention name(s): Bruton's tyrosine kinase (BTK)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Single Ascending Dose (SAD), Healthy Volunteers
Chest Physiotherapy After Bariatric Aurgery - A Comparison Between Incentive Spirometry and Expiratory Positive Airway Pressure (Epap)
Condition: Obesity
Study type: Interventional

Summary: 
      Objective: To compare the effects of the EPAP and the incentive spirometry flow-oriented in
      the pulmonary function after bariatric surgery.

      Method: Twenty-eight women, non-smokers, with no lung disease and BMI of 35-49,99 kg/m2,
      undergoing bariatric surgery by laparoscopy, were studied. Before surgery the patients were
      divided in two groups: Spirometer Group (SG) (n=13) and EPAP Group (EG) (n=15). Pulmonary
      function was evaluated by spirometry, thoracoabdominal (cirtometry) and diaphragmatic motion,
      on the preoperative and on the second postoperative day. Physiotherapy started on the day of
      surgery, each modality (incentive spirometry or EPAP) performed lasting 15 minutes. The
      deambulation and active exercises of upper and lower limbs were standardized for groups.
    


Intervention name(s): Incentive Spirometry - RESPIRON; Kit Epap®:
Intervention type(s): Device; Device
Intervention description(s): Device that stimulates the deep breathing, flow-oriented; Device that providing constant positive pressure during expiration, given by spring load (cmH2O), using a face mask as an interface
Other intervention name(s): EPAP - End positive airway pressure; Spring Load by mask
Keywords: Physiotherapy; Breathing exercises; Bariatric Surgery; Laparoscopy
Safety Study of Subthalamic Nucleus Gene Therapy for Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety of using a modified virus to transfer a
      gene called GAD into a region of the brain called the subthalamic nucleus in patients with
      advanced Parkinson's disease. The overall goal of this approach is to ultimately normalize
      the flow of information in several brain regions responsible for movement, to ultimately
      improve function in patients with this disorder. The current study is primarily designed to
      evaluate the safety of this approach, but patients are also being monitored for possible
      signs of effectiveness as well.
    

Detailed description: 
      This study involves treatment of patients with medically refractory Parkinson's disease (PD)
      with gene therapy. The patients are chosen from a population of patients who would normally
      be candidates for standard deep brain stimulation (DBS) surgery for PD. These patients
      respond to medical therapy, but develop substantially reduced responses over time, often with
      severe fluctuations in their condition between a functional and severely non-functional
      state. Some patients also develop dose-limiting side effects from medication, including
      involuntary movements called dyskinesias and nightmares. When there are no medical
      contraindications, DBS is often performed in these patients to try to quiet hyperactive brain
      regions such as the subthalamic nucleus (STN). In PD, the STN is overactive due to a loss of
      GABA inputs to this region, which normally reduces neuronal firing. In turn, the STN drives
      other brain regions, including the globus pallidus (GPi) and substantia nigra (SNr), which
      are also hyperactive and which also have reduced GABA inputs. The goal of this gene therapy
      trial is to introduce the gene for glutamic acid decarboxylase (GAD) into the STN using an
      adeno-associated virus (AAV) vector, in order to permit the STN to produce it's own GABA, as
      well as release GABA into the GPi and SNr targets, which also have reduced GABA inputs. This
      is anticipated to restore a more normal pattern of information flow from this basal ganglia
      circuit to the thalamus and higher cortical structures in order to reduce the motor symptoms
      of PD, while eliminating complications arising from inserting DBS electrodes and batteries
      into the human body.
    

Intervention name(s): Surgical infusion of AAV-GAD into the subthalamic nucleus
Intervention type(s): Genetic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson's disease; GABA; Subthalamic nucleus; Adeno-associated virus; AAV; Gene therapy
The Effectiveness of Bilateral Alternating Tactile Stimulation for Improving Sleep in Children
Condition: Sleep; Sensory Disorders
MeSH terms: Sensation Disorders
Study type: Interventional

Summary: 
      The investigators hypothesize that wearing bilateral therapeutic vibrating devices before bed
      will result in positive changes in outcome measures related to sleep (e.g., sleep efficiency)
      in children who are sensitive to stimuli in their environment (aka sensory over
      responsiveness or SOR).
    

Detailed description: 
      The purpose of this research study is determine if providing bilateral alternating
      stimulation to the extremities is effective for improving sleep in children with sensory
      processing difficulties. The investigators will use Touchpoints to deliver the intervention.
      The Touchpoints look like a regular watch, and vibrate at different low level frequencies to
      produce a calming effect on the body. More information about Touchpoints can be found here:
      https://thetouchpointsolution.com/pages/shop-touchpoints. The investigators hypothesize that
      these types of wearable vibrating devices may help children fall asleep faster and possibly
      stay asleep longer. This study will allow the research team to test these assumptions.

      In this study, each child will be asked to do the following things:

        1. Wear an activity tracker watch on their wrist before bed and through the night for 10
           days consecutively (Baseline)

        2. Wear both the activity tracker watch (wrist) and the Touchpoints (both ankles) before
           bed and during sleep for 10 days straight. (Intervention)

        3. Wear the activity tracker watch on their wrist before bed and through the night for 10
           additional days (post-test)

      During the study, the parents will be asked to fill out a brief sleep diary.
    

Intervention name(s): Touchpoints
Intervention type(s): Other
Intervention description(s): Touchpoints are worn on either the wrists or ankles. They deliver a low level vibration in an alternating fashion to the skin.
Intervention model: Single Group Assignment
Intervention model description: This study will use a non-concurrent multiple baseline design (MBD) where subjects will serve as their own control.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sleep; sensory over-responsiveness; hypersensitivity
Increase Breastfeeding Duration Among Puerto Rican Mothers
Condition: Breastfeeding
Study type: Interventional

Summary: 
      This study is to determine preliminary effects of home-based individual breastfeeding
      consultation with and without cash incentives to increase breastfeeding (BF) duration among
      low-income Puerto Rican mothers enrolled in a Special Supplemental Nutrition Program for
      Women, Infants, and Children (WIC).
    

Detailed description: 
      This study is to determine feasibility, acceptability, and preliminary effect sizes of
      home-based individual breastfeeding consultation alone and combined with financial incentives
      to increase breastfeeding (BF) duration among low-income Puerto Rican mothers. These
      interventions will be tested in a Women, Infants, and Children (WIC) program, which
      capitalizes on the current goals of WIC and on the current practice of using incentives to
      support BF - factors that are likely to increase potential for sustainability and
      dissemination of the intervention. We will follow a three phase strategy. During the
      Formative Phase we will consult WIC staff, Puerto Rican postpartum mothers, and experts in
      BF, behavioral health incentives, and WIC populations and settings to develop intervention
      and research manuals. During the Implementation Phase, we will pilot the interventions and
      research procedures. We will randomly assign 60 Puerto Rican women who initiate BF to:
      Treatment-as-Usual (TAU) or TAU with financial incentives (also known as Contingency
      Management; (CM). A bilingual breastfeeding counselor visits participants at home for problem
      solving issues around breastfeeding. Participants also receiving CM will receive cash
      incentives if they show breastfeeding. We will conduct assessments at baseline, 1, 3, and 6
      months postpartum, measuring BF duration, BF exclusivity, BF self-efficacy, and infant weight
      gain. In the Evaluative Phase, we will examine monthly recruitment, consent, and enrollment
      rates, as well as attendance and retention rates for the interventions and for research
      participation (i.e., feasibility and acceptability).
    

Intervention name(s): Contingency Management
Intervention type(s): Behavioral
Intervention description(s): Participants in this condition will receive usual WIC care in addition to Contingency Management (CM). BF will be determined by direct observation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breastfeeding duration; Puerto Rican mothers; WIC program; Home-based individual breastfeeding consultation
Efficacy of Acupuncture for Prophylaxis of Intrathecal Morphine Induced Pruritis in Patients Undergoing Caesarean Delivery
Condition: Acupuncture; Morphine Induced Pruritis
MeSH terms: Pruritus
Study type: Interventional

Summary: 
      Intrathecal morphine is commonly used for pain relief in caesarean delivery. Side effects
      such as itch (pruritis) and nausea & vomiting are common and have been shown to be the most
      common cause for dissatisfaction. The incidence of pruritis is 74% even with current
      available medications. Acupuncture has been shown to be effective for morphine related side
      effects but has not been evaluated for prophylaxis of itch in pregnant population.

      PRIMARY OBJECTIVE:

      Acupuncture at LI 11 reduces the incidence of pruritis after elective caesarean section under
      spinal with intrathecal morphine
    


Intervention name(s): ACUPUNCTURE AT LI11; SHAM ACUPUNCTURE
Intervention type(s): Device; Device
Intervention description(s): ACUPUNCTURE AT LI11 FOR 30 MINUTES PRIOR TO INTRATHECAL MORPHINE & LEFT IN PLACE FOR 30 MINUTES; SHAM ACUPUNCTURE AT A POINT 2 CM LATERAL TO LI11 30 MINUTES PRIOR TO INTRATHECAL MORPHINE & LEFT IN PLACE FOR 30 MINUTES
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Caesarean Delivery; Pruritis; Intrathecal Morphine; Acupuncture At LI11
Transcranial Direct Current Stimulation and Robotic Therapy in Upper Limb Motor Recovery After Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The objective of the study is to evaluate the effectiveness of transcranial direct current
      stimulation (tDCS) integrated with wrist robot-assisted treatment. In detail, the anodal
      stimulation on the impaired hemisphere will be used associated with a robotic treatment.
    

Detailed description: 
      As for transcranial direct current stimulation a HDC kit (ATES/EB NEURO, Firenze, Italy) will
      be used as device. It is a new device generation of stimulator able to provide an effective
      stimulation pattern.

      As robotic device the InMotion wrist robot (Interactive Motion Technologies Inc., Watertown,
      MA, USA) will be used. It is an end-effector robotic device able to assist as needed the
      wrist movements.
    

Intervention name(s): tDCS plus wrist robot therapy; Sham tDCS plus wrist robot therapy
Intervention type(s): Device; Device
Intervention description(s): Patients receive robotic rehabilitation session while tDCS stimulator is switched on; Patients receive robotic rehabilitation session while tDCS stimulator is switched off.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment