bioihbjkbjnl/mcl2 huggingface dataset:
Wearable Device for Motivating Hand Use After Stroke
Condition: Cerebral Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The goal of this study is to determine the effectiveness of interactive feedback from a
      wearable device that senses hand function, the Manumeter, in improving upper extremity
      function in a pilot, randomized controlled trial with chronic stroke patients
    

Detailed description: 
      In this randomized controlled trial, the investigators will compare two groups of chronic
      stroke participants Group 1 of study participants will use the Manumeter with interactive
      functions to monitor and motivate upper extremity functional activity. Group 2 of study
      participants will use the Manumeter but receive no feedback and will be given the current
      standard-of-care, a booklet describing a home exercise program for increasing upper extremity
      exercise. The investigators hypothesize that study participants who interactively monitor
      functional activity with the Manumeter will improve their upper extremity function
      significantly more.
    

Intervention name(s): Manumeter
Intervention type(s): Device
Intervention description(s): A manumeter is a first-of-its-kind magnetic sensor to wirelessly detect hand and arm movement in a socially acceptable and easy to don package. The study participants will wear a small magnet as a ring, and a sensing/logging wristband detects changes in the magnetic field as the ring moves; the wristband can detect arm accelerations.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Immunotherapy of Nasopharyngeal Cancer Using Cancer Stem Cells Vaccine
Condition: Neoplasms, Lung
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors
      into immunosuppressed mice, preventing an assessment on the immunologic interactions and
      effects of CSCs. In this study, the investigators examined the vaccination effects produced
      by CSC-enriched populations from histologically distinct murine tumors after their
      inoculation into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic
      and more effective as an antigen source than unselected tumor cells in inducing protective
      antitumor immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which
      bound to CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from
      peripheral blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were
      capable of killing CSCs in vitro. Mechanistic investigations established that CSC-primed
      antibodies and T cells were capable of selective targeting CSCs and conferring antitumor
      immunity.
    

Detailed description: 
      To assess the feasibility of generating CSC-loaded DC vaccines for clinical use, the
      investigators will harvest peripheral blood and tumor specimen from patients with
      Nasopharyngeal Cancer. The investigators will purify T, B cells and generate DCs from the
      PBMCs of the nasopharyngeal cancer patient.On the other hand, investigators will isolate
      ALDHhigh and ALDHlow tumor cells from the tumor specimen of the nasopharyngeal cancer patient
      using a similar protocol as investigators reported .

      Aim 1: To demonstrate, in vitro, the relative cellular anti-nasopharyngeal cancer CSC
      immunity induced by nasopharyngeal cancer CSC-DC primed cytotoxic T cells.

      Aim 2: To determine, in vitro, specific binding and lysis of nasopharyngeal cancer CSCs by
      antibodies produced by purified B cells from PBMCs stimulated with nasopharyngeal cancer
      CSC-DC.
    

Intervention name(s): cancer stem cell vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Anesthesia for Ambulatory Pediatric Surgery in Sub-Saharan Africa (SSA)
Condition: Complications
Study type: Interventional

Summary: 
      Long surgical wait-times and limited hospital capacity are common obstacles to surgical care
      in many countries in sub-Saharan Africa (SSA). Ambulatory surgery might offer a solution to
      these problems. The aim is to study the introduction of ambulatory surgery in a pediatric
      hospital in SSA.

      This is a cross-sectional descriptive study which took place over 6 months. It includes all
      the patients assigned to ambulatory surgery in the Pediatric University Hospital in
      Ouagadougou, Burkina Faso.
    


Intervention name(s): Anesthesia for ambulatory paediatric surgery
Intervention type(s): Procedure
Intervention MeSH terms: Anesthetics
Intervention model: Single Group Assignment
Masking: None (Open Label)
Study of Thymosin α1 to Reduce Acute Pneumonia For Bulky None-small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Pneumonia; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase II study is to determine the efficacy of Thymosin α1 on the frequency of acute
      pneumonia in non-small cell lung cancer with bulky tumor.
    

Detailed description: 
      This Phase II study is to determine the efficacy of Thymosin α1 on the frequency of radiation
      pneumonitis in non-small cell lung cancer with bulky tumor.

      All patients received four cycles of weekly docetaxel (25mg/㎡) and nedaplatin (25mg/㎡)(DP),
      each of 1 day's duration, combined with split-course thoracic radiotherapy of 51 Gy in 17
      fractions or 40 Gy in 10 fractions as the first course followed by a break of four weeks.
      Patients without disease progression had a dose of 15 Gy in 5 fractions or 24 Gy in 6
      fractions as a boost. Patients were further treated with subcutaneous injections of thymosin
      once a week,1.6mg each time from the start of radiation to 2 months after the end of
      radiation. Toxicities will be graded according to CTCAE v. 4.0.
    

Intervention name(s): Concurrent chemotherapy; split-course radiotherapy; thymosin alpha 1
Intervention type(s): Drug; Radiation; Drug
Intervention description(s): Concurrent chemotherapy consists of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration.; Patient was administered with 51 Gy in 17 fractions or 40 Gy in 10 fractions as the first course followed by a break of four weeks. Patients without disease progression had a dose of 15 Gy in 5 fractions or 24 Gy in 6 fractions as a boost; subcutaneous injections of thymosin once a week,1.6mg each time from the start of radiation to 2 months after the end of radiation.
Intervention MeSH terms: Thymalfasin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non-small Cell Lung Cancer; Split-course Chemoradiotherapy; Thymosin a1
Virtual Reality on Pain, Fear, and Emotional Appearance During Phlebotomy in Pediatric Hematology and Oncology Patients
Condition: Virtual Reality; Pain, Acute; Pediatric Cancer
MeSH terms: Acute Pain
Study type: Interventional

Summary: 
      In this study, the effect of virtual reality, which is one of the pain relief methods, on the
      pain, fear and emotional appearance associated with the procedure, was evaluated in children
      aged 4-12 years who will undergo phelobotomy in a Pediatric Hematology and Oncology
      outpatient clinic.
    

Detailed description: 
      This prospective randomized controlled study was conducted in the pediatric hematology and
      oncology polyclinic blood collection unit of a university hospital in Turkey.

      Patients undergoing phelobotomy were allocated to virtual reality or control groups according
      to a stratified randomization scheme.
    

Intervention name(s): Virtual Reality
Intervention type(s): Behavioral
Intervention description(s): Oculus Quest 2 256 GB All-In-One Vr Virtual Reality Glasses were used in the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: virtual reality; phlebotomy; pain; fear; anxiety; emotional apperance
A Long-Term Trial Investigating Safety and Efficacy of TransCon hGH in Children With Growth Hormone Deficiency Who Have Completed a Prior TransCon hGH Clinical Trial
Condition: Growth Hormone Deficiency, Pediatric; Endocrine System Diseases; Hormone Deficiency; Pituitary Diseases
MeSH terms: Dwarfism, Pituitary; Pituitary Diseases; Endocrine System Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      A multicenter, phase 3, long-term extension trial of TransCon hGH administered once-weekly in
      children with growth hormone deficiency (GHD) who previously participated in a phase 3
      TransCon hGH trial. Approximately 300 children (males and females) with GHD will be included.
      All study participants will receive TransCon hGH. This is a global trial that will be
      conducted in, but not limited to, the United States, Poland, Bulgaria, Ukraine, Armenia,
      Russia and Australia.
    


Intervention name(s): TransCon hGH
Intervention type(s): Drug
Intervention description(s): Once weekly subcutaneous injection of TransCon hGH
Intervention model: Single Group Assignment
Intervention model description: All study participants will receive TransCon hGH
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Human Growth Hormone; hGH; GHD; rhGH; Pediatric Growth Hormone Deficiency; Long Acting Growth Hormone; Somatropin; Prodrug; Growth Failure; Growth Hormone Replacement Therapy; Sustained Release Growth Hormone; Growth Hormone Deficiency; TransCon GH
Phase I/II Study of Avelumab in Pediatric Cancer Subjects
Condition: Refractory or Relapsed Solid Tumors; Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multi-center, open-label, international study to evaluate the dose, safety and
      tolerability, antitumor activity, pharmacokinetic and pharmacodynamics of avelumab in
      pediatric subjects 0 to less than 18 years of age with refractory or relapsed malignant solid
      tumors (including central nervous system tumors) and lymphoma for which no standard therapy
      is available or for which the subject is not eligible for the existing therapy.

      The study was planned to be conducted in 2 parts: the dose-finding part (Phase I) and the
      tumor-specified expansion part (Phase II). However, Phase II was cancelled due to limited
      clinical benefit of PD-L1 monotherapy in pediatric participants.
    


Intervention name(s): Avelumab; Avelumab
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive avelumab administered intravenously (IV) once every 2 weeks.; Subjects will receive avelumab at a recommended phase II dose (RP2D) adjudicated by a safety monitoring committee (SMC) from phase I part of the study.
Intervention MeSH terms: Avelumab; Antibodies, Monoclonal
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Avelumab; Anti PD-L1; Solid tumors; CNS tumors; Lymphoma; Pediatric subjects
Effect of Osteoanabolic Exercises on Gait, Balance & Fear of Fall Among Osteoporotic Females
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      With the increase in life expectancy women spend more than one-third of their life time in
      post-menopausal state leading to osteoporosis in later stages. Therefore a decrease in
      temporal-spatial parameters of gait, high risk of fracture, imbalance in functional
      parameters, fear of fall and compromised health-related quality of life is observed among
      osteoporotic females. Several physical activities and balance training programs have been
      implemented globally but nationally no program has yet been designed catering gait balance
      and fear of fall altogether as a combined program. Therefore, the aim of this study was to
      determine the effectiveness of Osteoanabolic exercises on Temporal-Spatial gait parameters,
      Gait Stability Ratio (GSR) and Bone Mineral Density (BMD) among the osteoporotic females.
      Moreover, the effectiveness of these exercises was evaluated on dynamic balance using Timed
      Up and Go Test (TUG).

      Furthermore, the impact on fear of fall was identified using Fall Efficacy ScaleInternational
      (FES-I).
    

Detailed description: 
      A 3-arm Randomized Controlled Trial was conducted at the Department of Rehabilitation
      Sciences, Ziauddin Hospital using the envelope method. The participants were screened on the
      Physical Activity Readiness and You Questionnaire (PARQ &YOU). Ninety-three osteoporotic
      females were randomly allocated into three groups; where; participant in group A' received
      aerobic training protocol, a participant in group B' resistance training and participant in
      group C' Osteoanabolic training. A Frequency Intensity Time Type (FITT) protocol according to
      the American College of Sports Medicine for aerobic and resistance training was incorporated
      whereas for Osteoanabolic group combination training protocol was used. Twelve weeks of
      training was conducted where pre and post readings were calculated using activPAL, TUG, FES-I
      and Peripheral DXA Scan.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): The exercises were performed for 12 weeks, for the maximum of 6 days/week for Osteoanabolic group, 5 days/week for aerobic group and 3 days/ week for a resistance group as per ACSM, FITT protocol.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoporosis; Bone Mineral Density; Postmenopausal
Efficacy of Ciclesonide on Small Airways in Patients With Stable Asthma (18 to 60 y) (BY9010/M1-131)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to evaluate the involvement of small airways in asthma, as
      determined by bronchial challenges, CT-scanning, and cellular markers of inflammation.
      Ciclesonide will be inhaled at one dose level once daily. The study duration consists of a
      baseline period (2 to 3 weeks) and a treatment period (5 to 6 weeks). The study will provide
      further data on safety and tolerability of ciclesonide.
    


Intervention name(s): Ciclesonide
Intervention type(s): Drug
Intervention MeSH terms: Ciclesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Asthma; Ciclesonide; Small Airways
Development Training in Babies Born Preterm
Condition: Premature Birth
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      The specific purpose of this study is to determine the effect of movement training on the
      onset of motor skills in babies born prematurely. We hypothesize that infants who participate
      in movement training will show advances in motor skills, visual attention, and toy-oriented
      behavior.
    

Detailed description: 
      The long term goal of this research program is to develop detailed intervention options for
      physical therapy treatment of very young preterm infants at risk for disability. The ability
      of infants to start reaching marks the beginning of an infants' ability to independently
      explore objects, and impacts development across multiple domains, including cognitive,
      language, and social. The aim of this study is to determine if bi-daily movement training
      will advance the reaching abilities of infants born preterm as compared to non-movement
      trained controls.

      Movement Training Group:

      Parents/Caregivers will be instructed to improve their infants' awareness and ability to
      reach for toys with their arms and legs by performing two sets of 10 minutes of daily
      exercises with them. The first 10 minutes will focus on improving awareness of their arms and
      toys (such as bells on their wrists). The second 10 minutes of activity that focuses on
      introducing infants to a task-space they rarely experience at this age, the task-space
      required for midline reaching (such as moving the infant's arm to a midline toy). An
      experimenter will visit each family in their homes every other week (the week that is not a
      testing week) to assure correctness of training, encourage full participation and answer any
      questions.

      Social Training Group:

      To control for increased social interaction that accompanies the enhanced training, parents
      of infants in this group will serve as a control group. Parent/Caregivers will be asked to
      perform 2x a day of 10 minutes face-to-face social interaction with their infants. Parents
      and infants will receive a 10 minute audio tape of popular kids' songs. They will be
      instructed to place infants supine or in a bouncy seat and interact with the infant visually
      and verbally during this time period along with the music.

      After the study is completed, each group will be offered the training booklet that the
      opposite group received.
    

Intervention name(s): Movement Training; Social Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This group of infants underwent specific movement training activities two times per day with their parents.; This group underwent special social interactions with their parents two times each day.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: premature birth; motor skills; learning; reaching
Clinical and Histologic Evaluation of Picato 0.15% Gel in the Cosmetic Improvement of Photoaged Skin
Condition: Actinic Keratosis; Photo-aged Skin
MeSH terms: Keratosis, Actinic; Keratosis
Study type: Interventional

Summary: 
      Clinical Evaluation:

      Subjects having actinic keratoses and meeting Glogau Photoaging Class III or IV complete the
      FDA approved 3 day course of Picato® 0.015% gel as approved for the treatment of facial
      Actinic Keratosis. Each subject undergoes clinical multiple-angle standardized photographs on
      day 1, day 7, day 30, and day 60. Full face photography will be obtained with the medical
      research digital camera. Both subjects and investigators complete questionnaires at each
      visit with individual questions regarding improvement in actinic keratoses and overall skin
      appearance, wrinkling, dyschromia, erythema, and textural quality of skin. Each
      characteristic listed above will be graded on a 5 point scale ranging from 0 (lowest
      quality/worst appearance) to 5 (highest quality/best appearance). In addition, investigators
      will examine the subject's face and assign a numeric assessment on a 9 point scale ranging
      from 0 to 8 using previously published verified Griffiths' Photonumeric Photoaging scale. A
      second and third investigator will be presented at random blinded pretreatment (day 0) and
      posttreatment (day 60) photographs of each subject and be asked to assign a numerical value
      from Griffiths' Photonumeric Photoaging Scale. These blinded investgators will be given no
      information regarding which day each photograph represents. Comparison will be made of skin
      quality questionnaire scores from each visit and the pre and post treatment Griffiths'
      Photonumeric Grades.

      The investigator opted against a split-face study design given the difficulty of blinding
      with this type of study as well as difficulty recruiting subjects willing to treat for two
      separate courses.

      Histologic Evaluation:

      Standard 3mm dermatology punch biopsies from clinically sun damaged skin will be taken.
      Biopsy will be taken from either the cosmetically acceptable pre-or infra-auricular area. A
      digital photograph will be taken and used to identify the pre-treatment biopsy site. Biopsies
      will be taken of 5 subjects before treatment and at day 60. Day 60 biopsies will be taken
      immediately adjacent to previously photographed and identified pre-treatment biopsies.
      Biopsies will be stained with hematoxylin and eosin and histologic features of pre and post
      treatment skin will be evaluated. Measurement of actinic keratoses, solar elastosis and
      overall epidermal and dermal thickness pre and post treatment will be compared.
    


Intervention name(s): Ingenol Mebutate (Picato®) 0.015% gel
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pilot Evaluation of a New Galyfilcon A Contact Lens Compared to a Marketed Galyfilcon A Contact Lens
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The purpose of this study is to compare lens surface characteristics and comfort between an
      experimental contact lens and a marketed contact lens.
    


Intervention name(s): galyfilcon A prototype lens; marketed galyfilcon A lens
Intervention type(s): Device; Device
Intervention description(s): Experimental silicone hydrogel contact lens; Marketed silicone hydrogel contact lens.
Other intervention name(s): ACUVUE(R) ADVANCE(TM)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Clinical Efficacy of Disulfiram in LAAM-Maintained Cocaine Abusers
Condition: Cocaine-Related Disorder; Opiate Dependence
MeSH terms: Cocaine-Related Disorders; Opioid-Related Disorders
Study type: Interventional

Summary: 
      This 18-week, randomized, double blind clinical trial provided treatment for 160
      cocaine-dependent opioid addicts, aged 18-65 years. Participants were stabilized on LAAM
      maintenance during the first 4 weeks and cocaine use was assessed; participants were then
      stratified by level of cocaine use and randomly assigned to receive one of the following:
      placebo disulfiram (0 mg/day), disulfiram at 62.5 mg/day, disulfiram at 125 mg/day, or
      disulfiram at 250 mg/day. During induction onto LAAM, participants were administered
      increasing doses of LAAM plus placebo disulfiram on a thrice-weekly basis until maintenance
      doses of LAAM are attained. At the beginning of week 5, participants received LAAM plus
      disulfiram or placebo disulfiram according to their randomized assignments, and were
      maintained on these agents through week 16. At the end of the study, participants underwent
      detoxification from LAAM and active/placebo medication over a 4- to 6-week period. All
      participants received weekly 1-hour psychotherapy (Cognitive Behavioral Treatment) with
      experienced clinicians specifically trained to deliver the therapy and who received ongoing
      supervision. The primary outcomes were retention and reduction in opioid and cocaine use, as
      assessed by self-report and confirmed by thrice-weekly urinalyses. Secondary outcomes
      included reductions in other illicit drug and alcohol use, as well as improvements in
      psychosocial functioning.
    


Intervention name(s): Placebo; Disulfiram; Disulfiram; Disulfiram
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Matched placebo.; disulfiram at 62.5 mg/day for 12 weeks.; Disulfiram at 125 mg/day for 12 weeks.; disulfiram at 250 mg/day for 12 weeks.
Intervention MeSH terms: Disulfiram
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment