bioihbjkbjnl/mcl2 huggingface dataset:
Feasibility Study of Low Level Light Therapy for Prevention of Oropharyngeal Mucositis in Pediatric Transplants Patients
Condition: Oropharyngeal Mucositis; Myeloablative Hematopoietic Cell Transplantation; Low Level Light Therapy
MeSH terms: Mucositis
Study type: Interventional

Summary: 
      Oral mucositis (OM) is a painful and potentially debilitating acute toxicity that frequently
      affects children undergoing hematopoietic cell transplantation (HCT). As a result of
      intensive conditioning with chemotherapy with or without total body irradiation, and in the
      case of allogeneic HCT, graft-versus-host disease (GVHD) prophylaxis, patients are at risk
      for developing diffuse ulcerations of the oral and esophageal mucosa that result in pain and
      suffering, increased utilization of opioid analgesics, and the need for intravenous or total
      parenteral nutritional support. Patients universally report OM as being the worst aspect of
      the HCT experience.A novel approach has been the use of larger light-emitting diode arrays to
      treat the at risk tissues from an extraoral approach, enabling exposure of the oral,
      oropharyngeal, and esophageal mucosa while avoiding the need for intraoral manipulation, and
      requiring only minimal patient cooperation. In this research study, the investigators are
      assessing the feasibility of providing extraorally delivered low level light therapy (LLLT)
      for the prevention of OM in children undergoing myeloablative HCT.
    

Detailed description: 
      This is an open label, single treatment arm clinical pilot study. The study is targeted to
      enroll twelve evaluable patients

      OBJECTIVES:

      Primary

        -  Determine the feasibility of providing extraoral LLLT for prevention of OM in pediatric
           patients undergoing HCT

      Secondary

        -  Determine the feasibility of collecting data using the WHO Oral Toxicity Scale and
           ChIMES in pediatric patients undergoing myeloablative HCT who are treated with extraoral
           LLLT for prevention of OM

        -  Evaluate the safety and tolerability of extraoral LLLT for prevention of OM in pediatric
           patients undergoing myeloablative HCT
    

Intervention name(s): Low Level Light Therapy
Intervention type(s): Device
Other intervention name(s): THOR Model LX2M (THOR Photomedicine Ltd, Chesham, UK)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Oropharyngeal Mucositis; Myeloablative Hematopoietic Cell Transplantation; Low Level Light Therapy
Single Dose Bioavailability and Ethnobridging PK Study in Healthy Subjects
Condition: Intestinal Disorder; Bowel Diseases, Inflammatory
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, 2-part, open-label study. Part A will be a formulation bridging and food
      effect study in healthy adult subjects. Part B will be an assessment of pharmacokinetics (PK)
      in healthy adult Chinese subjects.
    

Detailed description: 
      In study Part A, healthy adult subjects will receive the following treatments in a cross-over
      design with a ≥10-day washout period between doses:

        -  Treatment A: Single dose of [Tablet A] TD-1473 proposed commercial tablet formulation on
           Day 1 in a fasted state;

        -  Treatment B: Single dose of [Tablet A] TD-1473 proposed commercial tablet formulation on
           Day 1 in a fed state;

        -  Treatment C: Single dose of [Tablet B] TD-1473 current clinical tablet formulation on
           Day 1 in a fasted state;

        -  Treatment D: Single dose of [Tablet B] TD-1473 current clinical tablet formulation on
           Day 1 in a fed state.

      In study Part B, healthy adult Chinese subjects will receive Treatment A: Single dose of
      [Tablet A] TD-1473 proposed commercial tablet formulation on Day 1 in a fasted state.
    

Intervention name(s): TD-1473 [Tablet A]; TD-1473 [Tablet B]
Intervention type(s): Drug; Drug
Intervention description(s): TD-1473 [Tablet A] (1 Tablet = Dose A) proposed commercial tablet formulation; TD-1473 [Tablet B] (2 Tablets = Dose A) current clinical tablet formulation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Caucasian Subjects; Healthy Chinese Subjects; Ethnobridging
Pharmacokinetics, Safety, and Tolerability of Lumateperone Long-Acting Injectable in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label study to determine the pharmacokinetics, safety and tolerability of
      single ascending doses of lumateperone long-acting injectable formulation in patients with
      schizophrenia. Patients will be enrolled in one of up to four cohorts. All patients will
      receive oral lumateperone for 5 days, followed by a 5-day washout of oral lumateperone, then
      followed by a single dose of lumateperone LAI.
    


Intervention name(s): Lumateperone Long-Acting Injectable
Intervention type(s): Drug
Intervention description(s): Lumateperone Long-Acting Injectable
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Trial of Zinc and Micronutrients in Tanzanian Children
Condition: Diarrheal Illnesses; Respiratory Illness; Growth Faltering
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomized clinical trial of multiple micronutrients, zinc, zinc + micronutrients, or
      placebo among 2400 children born to HIV-negative Tanzanian mothers.
    

Detailed description: 
      We propose to study the efficacy of zinc or multiple micronutrient supplementation in
      reducing the risk of infectious diseases and growth faltering among infants and young
      children in Tanzania. Infants born to HIV-negative women will be recruited and randomly
      assigned in a factorial design to either zinc, micronutrients (vitamins C, E, B1, B2, niacin,
      B6, folate and B12), micronutrients plus zinc, or a placebo given daily. Children will be
      followed at monthly clinic visits from age 6 weeks for 18 months. Data obtained will include
      socioeconomic status, anthropometric data (weight, length, head circumference, and arm
      anthropometrics), dietary intake (including breastfeeding duration and frequency),
      hemoglobin, ferritin, and blood smear for malaria. The primary outcomes will be the incidence
      of diarrhea and respiratory tract infections. Secondary outcomes will be weight and length
      gain. A subset of children will be tested for blood concentrations of vitamin A, E, zinc and
      C-reactive protein. All children will receive a large periodic dose of vitamin A every 6
      months as per standard of care in Tanzania.
    

Intervention name(s): Zinc; Multivitamins; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): zinc; Vitamins C, E, B1, B2, niacin, B6, folate and B12; Placebo
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV; Tanzania; Micronutrients; Infants/children; Infectious Disease; Growth faltering
A Clinical Evaluation of Metal Ion Release From Metal-on-Metal Cementless Total Hip Arthroplasty
Condition: Osteoarthritis; Avascular Necrosis; Traumatic Arthritis; Rheumatoid Arthritis
MeSH terms: Arthritis; Necrosis
Study type: Interventional

Summary: 
      A clinical Evaluation to determine metal ion release from 4th generation metal-on-metal hip
      articulating surfaces in cementless total hip arthroplasty.
    

Detailed description: 
      This evaluation is being conducted to investigate the extent of metal ion release and its
      incorporation into the surrounding tissue resulting from metal on metal articulating surfaces
      in cementless total hip arthroplasty.

      The amount of metallic ions released post operatively will be assessed by the concentration
      of Cobalt, Chromium and Molybdenum present in urine and analysed by I.C.P.M.S. (Inductive
      Coupled Plasma Mass Spectroscopy). The amounts of metallic ions released will be related to
      the hip function and range of motion measured pre-operatively and post-operatively. Secondary
      performance of the metal-on-metal articulation will be determined by radiographic evaluation
      and incidence of complications / revision rates.
    

Intervention name(s): Metal on Metal cementless hip
Intervention type(s): Procedure
Intervention description(s): Metal on Metal hip arthroplasty
Other intervention name(s): metal on metal hip arthroplasty
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Lithium Versus Divalproex for Treating Pediatric Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This study compared the efficacy of lithium, divalproex, and placebo in treating the acute
      phase of symptomatic bipolar I disorder, mixed or manic episode, in children and adolescents.
    

Detailed description: 
      Primary Aim:

      To compare the efficacy of lithium (LI), divalproex (DVP), and placebo (PBO) in the acute
      phase treatment of symptomatic bipolar I disorder, mixed or manic episode, in children and
      adolescents. Our hypothesis is that differential efficacy will be observed with the following
      predicted order of response: divalproex (DVP) = lithium (LI) > placebo (PBO).

      Secondary Aims:

        1. To collect systematic safety data on the incidence of weight gain and the development of
           insulin resistance and hyperandrogenism in bipolar adolescent females treated with LI,
           DVP, or LI + DVP.

        2. To collect data on possible predictors of acute treatment response to the two active
           treatments.

        3. To provide descriptive information on the stability of acute phase response to
           monotherapy with either LI or DVP over 6 months of continuation phase treatment.

        4. To develop safety and efficacy data about the use of stimulant medications in these
           subject while treated with a mood stabilizer.
    

Intervention name(s): Lithium; sodium divalproex; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): lithium; Depakote; Placebo
Other intervention name(s): Lithobid; Depakote
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: child; adolescent
Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic SCT Using FluBuATG
Condition: Leukemia, Lymphoid; Leukemia, Myeloid; Myelodysplastic Syndromes; Myelofibrosis; Lymphoma, Malignant; Multiple Myeloma; Waldenstrom Macroglobulinemia
MeSH terms: Leukemia; Multiple Myeloma; Waldenstrom Macroglobulinemia; Leukemia, Myeloid; Leukemia, Lymphoid; Lymphoma; Myelodysplastic Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is examining a chemotherapy regimen and immune suppressive medications in the
      setting of an allogeneic stem cell transplant. A pilot clinical trial to characterize the
      incidence, prevalence and function of myeloid-derived suppressor cells (MDSCs) and immune
      checkpoint regulators (V-domain Ig Suppressor of T-cell Activation [VISTA], cytotoxic
      T-lymphocyte- associated protein 4 [CTLA-4], programmed death-ligand 1 [PD-L1]) during early
      immune recovery following an allogeneic stem cell transplant. The site will use a
      myeloablative regimen of fludarabine with busulfan, adopted from CALGB 100801, to define
      clinical endpoints, including engraftment, 100 day survival and one year survival (Objective
      #1). The site will characterize the incidence, prevalence and function of MDSCs and immune
      checkpoint regulators in patients' blood and bone marrow following transplantation (Objective
      #2). The site will correlate these laboratory results with clinical outcomes and the
      incidence of graft-versus-host disease (GVHD). As an exploratory aim, in those patients
      experiencing GVHD and requiring treatment, the site will define the MDSCs frequency and
      checkpoint regulator expression and correlate these results with the patient's response to
      GVHD therapy.
    


Intervention name(s): Fludarabine; Busulfan; Rabbit ATG; Methotrexate
Intervention type(s): Drug; Drug; Biological; Drug
Intervention description(s): Fludarabine: 30 mg/m2 daily for 5 days; Busulfan: 100 mg/m2 daily for 4 days; Rabbit ATG:
Related donors: 1.5 mg/kg daily x 2 days (on days -6 and -5) Unrelated donors: 1.5 mg/kg on day - 6 2 mg/kg on day -5 2.5 mg/kg on day -4; Methotrexate:
Related donors: 5 mg/m2 on days 1, 3 and 6 Unrelated donors: 5 mg/m2 on days 1, 3, 6 and 11
Intervention MeSH terms: Methotrexate; Fludarabine; Busulfan; Thymoglobulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluate Efficacy of Respiratory Rehabilitation Personalized Mobile Services for Respiratory Diseases
Condition: Respiratory Disease; Lung Cancer; COPD
MeSH terms: Respiratory Tract Diseases; Respiration Disorders
Study type: Interventional

Summary: 
      This trial is multicenter prospective study to evaluate clinical efficacy of respiratory
      rehabilitation personalized mobile services for respiratory disease.
    

Detailed description: 
      Patients with Lung Cancer or COPD who need respiratory rehabilitation were enrolled in this
      trial. The subjets were randomized to 3 group(A: Fixed respiratory rehabilitation program
      group, B: Mixed respiratory rehabilitation program group(Fixed respiratory rehabilitation for
      6 weeks, and then responsive respiratory rehabilitation for 6 weeks) and C: Control
      group(Ordinary rehabilitation service of the site)).

      Patients in Group A&B were provided with mobile application and wearable O2 saturation
      machine and mobile application monitors physical activity and provides

        1. how to do stretching, weight training with The-ra Band

        2. daily and weekly target of exercise

        3. alarm algorithms depending on patient's respiratory status(purse rate and O2 saturation)
    

Intervention name(s): Fixed respiratory rehabilitation; Responsive respiratory rehabilitation
Intervention type(s): Other; Other
Intervention description(s): There are 6 step-exercise presented in the application and initial target of exercise will be set according to subject condition. After subject completes targeted exercise, next step will be started.; The application provide responsive exercise program by changing type and numbers of exercise according to subject condition and exercise ability (This will be assessed with monitored O2 saturation, symptom of dyspnea and pulse rate during exercise)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The subjets were randomized(1:1:1) to 3 group(A: Fixed respiratory rehabilitation program group, B: Mixed respiratory rehabilitation program group( Fixed respiratory rehabilitation for 6 weeks, and then responsive respiratory rehabilitation for 6 weeks) and C: Control group(Ordinary rehabilitation service of the site).
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: respiratory rehabilitation; personalized mobile services
Autologous Transplantation of Melanocytes for Treatment of Vitiligo Skin
Condition: Vitiligo
MeSH terms: Vitiligo
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the efficacy and safety of autologous
      transplantation of melanocytes in patients with vitiligo.
    

Detailed description: 
      Vitiligo is a pigmentation disorder in which white patches of skin appear on different parts
      of the body. Histologically it is characterized by absence of melanocytes along the epidermal
      basal layer.

      Using cell suspension with non-cultured melanocytes which injected into blister of
      depigmented lesion, a success rate of 85% was reported for repigmentation. However there are
      some limitations in this technique: the induction of blister is limited to several sites of
      the body, hypo-pigmentation around the recipient area due to cryodamage of peripheral
      melanocytes and leakage of suspension out of the blister. To reduce these problems, in this
      study we will inject melanocytes directly to epidermis.

      A shaved biopsy specimen (about 1 cm2) is taken from the patient's normally pigmented area
      under local anesthesia (lidocaine hydrochloride 20 mg/ml). The specimens are incubated in
      0.25% trypsin solution for 15 minutes at 37°C 0.02% EDTA solution for 10 minutes. Then
      epidermal sheets are gently manipulated with forceps to dissociate the epidermal cells and to
      yield a cell suspension, followed by treatment with 0.5% trypsin/versene solution at 37C for
      3-5 minutes. Well-dispersed cell suspension is aspirated into 1 ml syringes and injected
      directly in epidermis.
    

Intervention name(s): Melanocyte transplantation
Intervention type(s): Biological
Intervention description(s): Injection of melanocytes directly in Epidermis
Other intervention name(s): cell therapy; cell transplantation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: melanocytes
Prevalence of Heavy Menstrual Bleeding in Female Population Living in Beijing
Condition: Menorrhagia
MeSH terms: Menorrhagia
Study type: Observational

Summary: 
      The purpose of the study is to estimate the prevalence of heavy menstrual bleeding (HMB) in
      females aged between 18 and 50 years old living in Bejing.
    

Detailed description: 
      This study is an observational, cross-sectional study. A representative sample of 2800
      eligible women with different occupations such as farmers, service providers, workers,
      professional specialists, students and civil servants will be recruited. A cluster sampling
      method with probability proportional to the distribution of occupation in women in Beijing
      will be used. Demographic data will be collected by questionnaire. Menstrual bleeding will be
      evaluated by Pictorial Blood loss Assessment Chart (PBAC). According to the international
      definition of HMB, a PBAC score more than 100 is considered as HMB.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        residents of Beijing
      
Keywords: Prevalence; Menorrhagia
Establishment of a Bank of Biospecimens for Future Research on Age-related Cognitive Disorders
Condition: Dementia; Alzheimers Disease
MeSH terms: Alzheimer Disease; Dementia; Cognitive Dysfunction; Cognition Disorders
Study type: Observational

Summary: 
      This study is collecting tissue specimens (blood, urine and saliva) from up to 1000 patients,
      with and without cognitive disorders, to store in the Bio Bank for future research. The
      specimens could be used in future research projects that could help improve the accuracy of
      diagnosis of a disease, predict who might develop a disease, help monitor the disease, or
      improve the understanding of the disease. Patients are only being recruited from Beaumont
      Hospitals Geriatric Clinic.
    

Detailed description: 
      Up to 1000 patients, with or without diagnosed cognitive disorders, are asked to participate
      by providing the investigators with blood, urine and saliva specimens to be stored in a Bio
      Bank for future research. Patients will be asked to participate on a yearly basis for up to 5
      to 10 years by providing the investigators with the above-mentioned specimens, and also
      having a physical exam and having some cognitive testing performed at the initial visit and
      yearly visits.

      Examples of the types of research are: new methods for improving the diagnosis and treatment
      of age-related cognitive disorders, new areas of biology, new areas of biotechnology, and
      possibly genetic research. If you do not want your specimens used for any specific type of
      research, you may specify that on the consent form.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will be obtained from individuals seen by the physicians affiliated with the
        Division of Geriatric Medicine at Beaumont Hospital in the Geriatric Clinic.
      
Biospecimen description: 
      Serum, Plasma, human platelet, urine (clarified), urine sediment, saliva
    
Keywords: Dementia; Alzheimers Disease; Cognitive Disorders; Tissue Banking
Gait Rehabilitation in Diplegic Children
Condition: Cerebral Palsy; Spastic Diplegia
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      Background: Standing and walking serve an individual's basic need to move from place to
      place, and both are the most common activities that people do on a daily basis.

      Aim: to investigate the combined effect of botulinum toxin A (BoNT-A) injection and ankle
      weight on the gait of diplegic children who are using Ankle foot orthoses.
    

Detailed description: 
      Methods: Sixty children with spastic diplegia were included in this prospective, controlled
      trial. Children were divided into three groups, each with 20 patients: Group 1 received
      classical gait rehabilitation; Group 2 received the same gait training while adding ankle
      weight ; and Group 3 received the same as group 2 plus botulinum toxin injection. The
      Modified Ashworth Scale (MAS),knee range-of-motion measures, and Hoffman /Myogenic reflex
      ratio were used to examine patients before the commencement of treatment and post-treatment.
    

Intervention name(s): gait training
Intervention type(s): Other
Intervention description(s): walking forward, sideway and backward walking on balance board
Other intervention name(s): rehabilitation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gait; diplegia; ankle weight; botox injection
Combined Functional Electrical Stimulation & Robotic Gait Training for Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      The purpose of this research study is to learn more about the usefulness of a physical
      therapy treatment that combines robot-assisted walking with electrical impulses that help to
      make muscles contract. This treatment is intended for children with cerebral palsy. Up to
      eleven children with cerebral palsy will receive up to 18 treatments and will have several
      evaluations before and after treatment.
    


Intervention name(s): Combined functional electrical stimulation and robotic gait training
Intervention type(s): Other
Intervention description(s): up to 18 sessions of approximately 45 minutes occurring over up to 9 weeks
Other intervention name(s): Lokomat; RT-50
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cerebral palsy; gait training; robotic; functional electrical stimulation