bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Synchronized Tele-exercise
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of this study is to determine the effect of telehealth-synchronized group exercise on
      sleep and quality of life, and secondarily, on the health and body perception of healthy
      young adults. This study is planned as a randomized double-blind controlled clinical study.
    

Detailed description: 
      The aim of this study is to determine the effect of telehealth-synchronized group exercise on
      sleep and quality of life, and secondarily, on the health and body perception of healthy
      young adults. This study is planned as a randomized double-blind controlled clinical study.
      The sample size was calculated using G*power 3.1.9.2, which required 42 patients and a size
      effect of 0.8, 80% power, 1:1 allocation ratio, and an error probability of 0.05. Forty-eight
      participants were planned to be included in the study, based on the probability that 15% of
      the patients could be excluded.
    

Intervention name(s): synchronized tele-exercise
Intervention type(s): Other
Intervention description(s): All evaluations and exercise interventions will be performed by via Google Meet, a video-conferencing application. The participation link will be sent to the individual by the researcher before each session. In case of any technological disruption, the session will be postponed to the nearest available time by phone. All interventions will be run by a blinded researcher.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Orexin and Tau Pathology in Cognitively Normal Elderly
Condition: Elderly; Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      Alzheimer's disease (AD) is a common neurodegenerative disease characterized by the
      accumulation of amyloid plaques and neurofibrillary tangles. Current consensus is that the AD
      pathological process begins decades before clinical symptoms occur. This long "preclinical"
      phase of AD might first become detectable in middle-age as deposits of hyperphosphorylated
      tau (P-tau) in the transentorhinal cortex and subcortical nuclei such as the locus coeruleus
      (LC) and the nucleus basalis of Meynert. There is strong preliminary evidence showing that
      cerebrospinal fluid (CSF) levels of orexin-A (OxA) are associated with increased P-tau
      (r=.52, p<.01) and total-tau (T-tau) (r=.42, p<.01) in cognitively normal older adults (mean
      age: 69.6±8.6 years).

      This study poses that onset of tauopathy in the LC results in down regulation of orexin
      receptors, leading to a homeostatic increase of OxA production by the hypothalamus, which
      results in changes in core body temperature (CBT) and sleep disruption that cause further
      neurodegeneration. This hypothesis will be tested by demonstrating that increases in CSF
      P-tau are associated in vivo with tau PET uptake, and that tau binding in the LC is
      associated with increases in CSF OxA (Aim 1); and second, by analyzing the downstream
      consequences of increased central nervous system (CNS) OxA on sleep architecture and CBT (Aim
      2). To test these hypotheses, 19 older adults (age 55-75) balanced by sex, will first perform
      a full clinical evaluation and PET-MRI where Tau burden will be analyzed by PET-MR using
      18F-MK6240 (visits 1-2). Subjects will later undergo 7 days of actigraphy followed by
      nocturnal polysomnography (NPSG) for 2 consecutive nights (N1-2) during which we will measure
      CBT (visits 3-4). A morning lumbar puncture (LP) will be performed after N2 to obtain CSF.
    

Detailed description: 
      There is the potential to identify: 1) an association between CSF P-tau and in vivo
      18F-MK6240 uptake; 2) a mechanism by which tau pathology may contribute to orexin
      dysfunction; 3) evidence that orexin dysfunction disrupts sleep and CBT rhythm; and, 4) CNS
      orexin dysfunction as a new therapeutic target for AD prevention.
    

Intervention name(s): Actigraphy; Nocturnal Polysomnograpahy (NPSG)
Intervention type(s): Procedure; Procedure
Intervention description(s): Recording of sleep/wake cycle and TST by actigraphy to be completed at home by subject over 7 days; N1 habituation and N2 data collection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Orexin; Core Body Temperature
Efficacy of Long-acting Octreotide (Sandostatin LAR) in Reducing Portal Pressure in Patients With Cirrhosis
Condition: Cirrhosis; Portal Hypertension; Esophageal Varices
MeSH terms: Liver Cirrhosis; Hypertension, Portal; Esophageal and Gastric Varices; Hypertension; Fibrosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Octreotide is used to control variceal bleeding. However, octreotide has to be given through
      the vein and is effective for less than two hours.

      In this study the investigators determined whether a long-acting preparation of octreotide
      (Sandostatin LAR)given as an intra-muscular injection every month could decrease portal
      pressure, and thus be used to prevent variceal bleeding in patients with cirrhosis.
    


Intervention name(s): Long acting octreotide 10mg; Long acting Octreotide 30mg; Saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Comparison of different doses; Comparison of drug doses; Comparison of drug doses
Other intervention name(s): Long-acting octreotide
Intervention MeSH terms: Octreotide
Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: portal hypertension; varices; cirrhosis; octreotide; somatostatin analog; Child Pugh Class A,B
Reducing Sedentary Behaviour in University Students Using Text Messages
Condition: Sedentary Lifestyle
Study type: Interventional

Summary: 
      The primary purpose of the current study was to determine whether a text message intervention
      would increase break frequency and length of break from sitting, time spent standing, and
      time spent in light and moderate intensity physical activity in university students
    

Detailed description: 
      Sedentary behaviour (SB) has been linked to many health problems (e.g., type 2 diabetes,
      heart disease). Interventions aimed at office workers, overweight and obese individuals have
      proven successful in reducing SB; however, no studies have examined university students.Text
      message-based interventions have succeeded to aid in smoking cessation and increase both
      physical activity and healthy eating, but have not been shown to reduce SB. Eighty-two
      university students were randomized into intervention (SB related text messages) or control
      (text messages unrelated to SB) groups. Participants received daily text messages and
      reported various SBs (i.e., breaks from sitting, standing, light and moderate intensity
      physical activity) at four time points (baseline, 2, 4 and 6 weeks).
    

Intervention name(s): text messages related to sedentary behaviour
Intervention type(s): Behavioral
Intervention description(s): texts sent twice daily encouraging reduced sedentary behaviour
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Effects of PEDALS Program Versus Lower Limb Strength Training in Diplegic CP
Condition: Cerebral Palsy,Diplegic
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      Cerebral palsy (CP) is a neurodevelopmental disorder is caused by damage to the developing
      brain and is characterized by abnormalities of muscle tone, mobility, and motor abilities. CP
      may only be recognized at 3-5 years of age. Pediatric endurance and limb strengthening
      (PEDALS) program is important to achieve endurance, gross motor function and some measure of
      strength in patients with diplegic cerebral palsy. The aim of this study is to evaluate the
      comparative effects of pediatric endurance and limb strengthening program with lower limb
      strength training in diplegic cerebral palsy.
    

Detailed description: 
      A randomized control trial will be conducted through convenient sampling. Subjects will
      randomly allocated into two groups, group A will receive pediatric endurance and limb
      strengthening program, while group B will receive lower limb strength training. The duration
      of the treatment will be 8 weeks. Goniometer, six minute walk test and gross motor function
      measure scale-88 will be used to as outcome measure. Goniometer measures the available range
      of motion at a joint, six minute walk test measure cardiorespiratory or aerobic endurance,
      the GMFM-88 provides more descriptive information about motor function for very young
      children or children with more complex motor disability, Data will be analyzed on SPSS
      version 27, normality of the data will be checked and tests will be applied according to the
      normality of the data either it will be parametric test or non-parametric based on the
      normality.
    

Intervention name(s): Pediatric Endurance and Limb Strengthening Program (PEDALS) and Lower Limb Strength Training; Lower Limb Strength Training Group
Intervention type(s): Other; Other
Intervention description(s): Pediatric Endurance and Limb Strengthening Program (PEDALS) Group This will receive stationary cycling; Lower Limb Strength Training Group
Other intervention name(s): This will receive functional strength training, plyometric, balance training
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Its a randomized control trial, used to evaluate the comparative effects of pediatric endurance and limb strengthening program with lower limb strength training in diplegic cerebral palsy. Subjects with diplegic cerebral palsy (GMFCS level 1-11) meeting the predetermined inclusion and exclusion criteria will be divided into two groups using simple random sampling technique
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Cerebral palsy, endurance, strength, training, pediatric
Study of Milnacipran for the Treatment of Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      Antidepressants of all varieties represent a common form of therapy for many chronic states
      including fibromyalgia. The majority of antidepressants increase the levels of serotonin or
      norepinephrine in the central nervous system. Milnacipran is a dual norepinephrine and
      serotonin reuptake inhibitor and may be effective in the treatment of fibromyalgia.
    


Intervention name(s): milnacipran hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Milnacipran; Levomilnacipran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: NSRI; milnacipran; fibromyalgia
External Beam Radiation Therapy and Cetuximab Followed by Irinotecan and Cetuximab for Children and Young Adults With Newly Diagnosed Diffuse Pontine Tumors and High-Grade Astrocytomas
Condition: Brain Cancer
MeSH terms: Astrocytoma; Brain Neoplasms; Brain Stem Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Standard treatment for patients with diffuse pontine tumors is radiation therapy, but less
      than 10% of patients are cured. Adding standard chemotherapy has not improved the cure rate.

      Standard treatment for high-grade astrocytomas is surgery and radiation. The surgeon removes
      as much of the tumor as she or he can. Radiation after that tries to kill any cancer cells
      that are left. Some patients also get chemotherapy. These are anti-cancer drugs. They can be
      given during or after radiation. Current standard treatments do not cure many patients.

      In this study the doctors are adding a new medication called cetuximab to the treatment and
      will also use a chemotherapy medication (irinotecan) that has been promising for patients
      treated for recurrent disease.
    


Intervention name(s): cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan
Intervention type(s): Other
Intervention description(s): External beam radiation therapy (5940 cGy in 180 cGy fractions) with weekly cetuximab (250 mg/m2/dose).4-8 weeks rest, 10 cycles of irinotecan (16 mg/m2/day x 5 consecutive days x 2 weeks) with weekly cetuximab (250 mg/m2/dose) at about 21 day intervals. Research biological evaluations will be performed in consenting patients as an optional portion of the study. Cetuximab is to be given every 7 days (+/- 2 days). Cetuximab does not need to be given on Day 1 of each week.
Intervention MeSH terms: Irinotecan; Cetuximab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: high-grade astrocytomas; newly diagnosed diffuse pontine tumors; External beam radiation therapy; cetuximab; irinotecan; POETIC
Virtual Reality Distraction for Reduction
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Using a randomized controlled design, the investigators goal is to estimate the effect of VR
      on postoperative analgesia and opioid consumption.
    

Detailed description: 
      Specifically, the investigators propose to test the primary hypothesis that the use of
      AppliedVR software in Pico G2 4K headsets decreases acute postoperative pain scores (with a 1
      point difference considered clinically important) compared to sham treatment on a 0-10 scale
      15 minutes after each use in the first 48 hours after surgery or hospital discharge,
      whichever comes first.
    

Intervention name(s): Placebo comparator: VR googles and the non reality experience; Active Comparator: VR googles and the real VR program to enter act with and experience
Intervention type(s): Device; Device
Intervention description(s): parallel assignment (this arm will receive a static presentation in the same device); Parallel assignment (this arm will receive the full immersive virtual reality experience
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: parallel assignment (one arm will receive the full immersive virtual reality experience and the other arm will receive a static presentation in the same device)
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
FlexNav EU CE Mark Study
Condition: Symptomatic Severe Aortic Stenosis
MeSH terms: Aortic Valve Stenosis; Constriction, Pathologic
Study type: Interventional

Summary: 
      The purpose of this clinical investigation is to characterize the safety of the
      next-generation FlexNav™ Delivery System for transfemoral implantation of the Portico™
      Transcatheter Aortic Heart Valve in symptomatic severe aortic stenosis patients who are
      considered of high or extreme risk for surgical aortic valve replacement. Data from the study
      will be used to support CE Mark of the FlexNav™ Delivery System and Loading System in Europe.
    

Detailed description: 
      The FlexNav European Union (EU) study will be conducted as a prospective, multi-center,
      single-arm investigational study.

      High or extreme risk patients with symptomatic, severe native aortic stenosis who are
      determined by an independent subject selection committee to meet eligibility criteria for
      Portico™ Transcatheter Aortic Heart Valve implantation via a transfemoral access approach
      will undergo a Portico valve implant using the next-generation FlexNav Delivery System.

      Subject data will be collected at screening, baseline, pre-procedure, peri-procedure,
      post-procedure, discharge, 30 days, 6 months and 1-year from the index procedure.
    

Intervention name(s): Portico Valve and FlexNav™ Delivery System
Intervention type(s): Device
Intervention description(s): Subjects will undergo transcatheter aortic valve replacement (TAVR) with the Portico valve and second-generation FlexNav Delivery system via a transfemoral access approach
Intervention model: Single Group Assignment
Intervention model description: Devices under investigation in this clinical investigation include the FlexNav™ Delivery System(s) (18 F and 19 F) and FlexNav™ Loading System(s) (Small and Large), which are both approved for investigational use only. Other devices to be used in the clinical investigation include all four (4) market released Abbott Portico™ valve sizes (23mm, 25mm, 27mm and 29mm).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aortic Stenosis; FlexNav™ Delivery System; Portico Delivery System; Transcatheter Aortic Valve Replacement; Heart Valve Disease; High surgical risk
Single Dose Crossover Comparative Bioavailability Study of Eslicarbazepine Acetate Versus To-be-marketed Formulation
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      Single center, randomized, single dose, laboratory-blinded, 2-period, 2-sequence, crossover
      design
    

Detailed description: 
      Single center, randomized, single dose, laboratory-blinded, 2-period, 2-sequence, crossover
      design to evaluate and compare the relative bioavailability and therefore the bioequivalence
      of three doses (400 mg, 600 mg and 800 mg) of eslicarbazepine acetate for two formulations
      (CTF versus TBM) after a single oral dose administration under fasting conditions
    

Intervention name(s): BIA 2-093
Intervention type(s): Drug
Intervention MeSH terms: Eslicarbazepine acetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Study of Tcelna (Imilecleucel-T) in Secondary Progressive Multiple Sclerosis
Condition: Autoimmune Diseases of the Nervous System; Multiple Sclerosis; Secondary Progressive Multiple Sclerosis; Disease Progression; Brain Atrophy
MeSH terms: Neoplasm Metastasis; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Nervous System Diseases; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Sclerosis; Disease Progression
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether Tcelna (imilecleucel-T, autologous T-Cell
      Immunotherapy) is effective in the treatment of secondary progressive multiple sclerosis
      (SPMS).
    

Detailed description: 
      Subjects whose myelin reactive T-cell can be identified by EPA will are randomized and
      provide blood to manufacture Tcelna. Approximately 5 weeks after receipt of the subject's
      whole blood procurement, the subjects will receive either Tcelna or placebo and will complete
      baseline assessments and will receive study treatments at Weeks 0, 4, 8, 12, and 24 (Visits
      3-7), totaling 5 doses in year one.

      Approximately one month prior to the Week 52 visit a second blood procurement will be
      performed and the subject will receive the second series of treatments as received in the
      first year study schedule. Subjects will be evaluated for changes in disability and cognitive
      function every 3 months, and radiographic changes annually.
    

Intervention name(s): Tcelna; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Autologous pool of myelin reactive T-cells (MRTC) expanded ex vivo with immunodominant epitopes selected from the three myelin antigens, MBP, PLP and MOG on a per subject basis. Attenuated by irradiation to prevent further proliferation before releasing product for administration.; 2 ml of Tcelna excipients, prepared daily as individual doses and irradiated before releasing product for administration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multicenter Study; Randomized Controlled Trial; Individualized Medicine; Immunotherapy; Myelin Proteins; Biological Agents
Induction Chemotherapy Followed by Chemoradiotherapy in Esophageal Cancer
Condition: Neoplasms
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The contribution of induction chemotherapy before definitive chemoradiotherapy is unknown.
      The purpose of this study was to compare the efficacy and toxicity of induction chemotherapy
      followed by definitive chemoradiotherapy versus no induction chemotherapy in patients with
      inoperable thoracic esophageal squamous cell carcinoma.
    

Detailed description: 
      108 patients were randomized to receive no induction chemotherapy (IC, Arm A) or IC (Arm B)
      before definitive chemoradiotherapy in patients with inoperable thoracic esophageal squamous
      cell carcinoma. Patients assigned to Arm B first received two cycles of 3-weekly schedule of
      IC, consisting of docetaxel 75 mg/m2 on day 1 and cisplatin 75 mg/m2 on day 1. The prescribed
      dose of radiotherapy is generally 50-60 Gy/25-28fr. The concomitant chemotherapy is docetaxel
      20 mg/m2 on day 1, cisplatin 25 mg/m2 on day 1, repeated weekly during radiation.
    

Intervention name(s): Docetaxel; Cisplatin; Radiotherapy
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): Include brand names, serial numbers and code names to improve search results on the ClinicalTrials.gov web site.; Include brand names, serial numbers and code names to improve search results on the ClinicalTrials.gov web site.; definitive radiotherapy
Other intervention name(s): taxotere; DDP; radiation
Intervention MeSH terms: Docetaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Esophageal cancer; Chemoradiotherapy; induction chemotherapy
Evaluation of Histamine H3 Receptor Radioligand [11C]AZ12807110 and Histamine H3 Receptor Occupancy of AZD5213 After Oral Administration
Condition: Brain Distribution of [11C]AZ12807110 and AZD5213
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate features of radioligand [11C]AZ12807110 and how
      much AZD5213 displaces radioligand from histamine receptors when given together.
    


Intervention name(s): [11C]AZ12807110; AZD5213
Intervention type(s): Other; Drug
Intervention description(s): Radioligand
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Receptor binding; Histamine H3 receptor; binding; radioligand
Evaluation of Triathlon - a New Total Knee Prosthesis System - Triathlon vs. Duracon
Condition: Arthroplasty, Replacement, Knee
Study type: Interventional

Summary: 
      The objective is to investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric
      behaviour and patient outcome when using the Triathlon total knee prosthesis in a prospective
      randomized clinical trial.
    

Detailed description: 
      The evaluation is carried out by a prospective randomised RSA-study with Triathlon cemented
      knee prosthesis versus Duracon cemented knee prosthesis.
    

Intervention name(s): Cemented Triathlon total knee system; Duracon total knee system
Intervention type(s): Device; Device
Intervention description(s): Orthopaedic implant; Orthopaedic implant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment