bioihbjkbjnl/mcl2 huggingface dataset:
Traumatic Brain Injury Peripheral Nerve Study
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      Peripheral nerve stimulation for the treatment of sequelae due to traumatic brain injury.
      This study will specifically examine patients with mild traumatic brain injury (TBI) who have
      persistent cognitive impairments lasting one year or longer. Neuropsychological testing will
      occur to confirm the diagnosis.
    

Detailed description: 
      The subject will complete participation in three groups evaluating different programming
      parameters. After surgery, each subject will be randomized to Group A or Group B. Group C
      will be completed in the middle followed by the alternate A/B Group. Crossover will occur at
      3 week intervals until subjects complete all three groups. During this period, all subjects
      will receive a subject programmer that will only enable them to activate the "on and off"
      positions and adjust amplitude within the prescribed range.

      After subjects have completed the three pre-defined groups they will select the most
      effective and comfortable setting continuation of the study. The pulse width and frequency
      parameters will be set to the optimal settings identified by the subject. Amplitude will be
      set at a level that produces comfortable paresthesia for the subject.

      Subjects will return to the clinic for programming changes post system internalization at 3
      weeks, 6 weeks, and 9 weeks. Subjects will receive a PET scan at the 3 and 9 week visit.
      Additional follow-up evaluations will occur at 12 weeks, 18 weeks, and 24 weeks.
    

Intervention name(s): Eon-mini IPG (implantable pulse generator); Eon-mini IPG (implantable pulse generator); Eon-mini IPG (implantable pulse generator)
Intervention type(s): Device; Device; Device
Intervention description(s): programming parameters set at low frequency. Patients will receive this therapy dose for 3 weeks.; programming parameters set at high frequency. Patients will receive this therapy dose for 3 weeks.; programming parameters set at lowest settings to deliver minimal power. Patients will receive this therapy dose for 3 weeks.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Traumatic Brain Injury
tDCS for the Management of Multiple Sclerosis Related Fatigue
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      This is a pragmatic clinical trial that aims to determine the effect of tDCS on symptomatic
      fatigue in Multiple Sclerosis (MS) patients. This is a randomized, blinded, sham-controlled
      study design to determine the effect of Transcranial Direct Current Stimulation (tDCS) on MS
      participants to reduce feelings of fatigue.120 participants with MS and
      clinically-significant fatigue (as defined by a score of >36 on the Fatigue Severity Scale)
      will be recruited to participate in either an active or sham treatment condition.
    


Intervention name(s): Active tDCS; sham tDCS
Intervention type(s): Device; Device
Intervention description(s): Active target 2.0mA tDCS (n=60); sham left-anodal dorsolateral prefrontal cortex (DLFPC) montage
Other intervention name(s): Soterix Mini-Ct Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Impact of Periodontal Treatment on NT-proBNP Levels
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional

Summary: 
      In light of the controversy that are already approved but that however still exists regarding
      the efficacy and influence the management of Periodontitis, the aim of this study was to
      evaluates, at 6-months follow-up, the post-treatment clinical and serum parameters in
      patients with periodontitis, treated by either Intensive scaling and root planing (SRP)
      treatment versus conventional oral hygiene treatment on serum CRP and NT-proBNP levels.

      The null hypothesis to invalidate was that there were no variations, in relation to clinical
      and serum CRP and NT-proBNP.
    

Detailed description: 
      This trial was conducted in accordance with the World Medical Association's Declaration of
      Helsinki of 1975, and reviewed in 2016. The local ethical committee approved the study
      protocol and each patient was carefully informed about the possible inherent risks of the
      study and provided their informed written consent.

      Subjects with a diagnosis of periodontitis were enrolled in this clinical trial. The
      inclusion criteria were: 1) good condition of general health, 2) a minimum of 2 teeth for
      each quadrant with a Pocket Depth (PD) ranging from 4-6 mm, 3) no involvement of the
      furcation, 4) a minimum of a six teeth per quadrant, respectively. The exclusion criteria
      were: 1) periodontal therapy during the last 12 months, 2) assumption of antibiotics during
      the last 6 months, 3) pregnancy, 4) any systemic condition which might affect the effects of
      the study treatment, 5) previous or current radiation or immunosuppressive therapies, 5) use
      of mouthwash containing antimicrobials during the previous 3 months, 6) no use of hormonal
      contraceptives, 7) medication by anti-inflammatory and immunosuppressive drugs, 8) previous
      history of hard-drinking, 9) smoking, 10) class II and III tooth mobility. Patients randomly
      undergo to full mouth SRP (test group) or oral hygiene treatment (control group)
    

Intervention name(s): Evaluation of serum CRP and NT-proBNP
Intervention type(s): Diagnostic Test
Intervention description(s): All patients were evaluated to 6-months post-treatment reduction of serum CRP and NT-proBNP
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Each selected patient underwent randomly, without anaesthesia, after recording periodontal parameters, the two following treatments: in one, maxillary quadrants were treated as conventional Scaling and Root Planing (SRP), while the control group undergo to standard oral hygiene treatment.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Periodontitis; serum markers; CRP; NT-proBNP
ION US Post-Approval Study
Condition: Atherosclerosis; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Atherosclerosis
Study type: Observational

Summary: 
      The purpose of this study is to compile real-world clinical outcomes data for the ION™
      Paclitaxel-Eluting Platinum Chromium Coronary Stent System in routine clinical practice.
    

Detailed description: 
      The ION™ stent is the third-generation Boston Scientific (BSC) paclitaxel-eluting coronary
      stent. It is designed for improved performance specific to deliverability and radio-opacity
      while maintaining a similar drug release profile of the TAXUS Express and TAXUS Liberté
      stents. Following PMA approval from the FDA for the ION™ Paclitaxel-Eluting Platinum Chromium
      Coronary Stent System the ION US Post-Approval study will compile real-world clinical
      outcomes data for the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System in
      routine clinical practice. Post-approval studies of drug-eluting stents (DES) provide an
      opportunity to observe and assess patient outcomes and technology performance in a real-world
      setting.
    

Intervention name(s): ION™ Coronary Stent System
Intervention type(s): Device
Intervention description(s): This study is intended to evaluate the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System across a range of institutions and physician users to observe and assess subject outcomes and technology performance in a real-world setting.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Consented subjects admitted to the cardiac catheterization laboratory for percutaneous
        transluminal coronary angioplasty and who are eligible to receive an ION™
        Paclitaxel-Eluting Platinum Chromium Coronary Stent.
      
Keywords: Atherosclerosis; Coronary Artery Disease
A Study of Brexpiprazole in Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess
      the safety and efficacy of brexipiprazole to placebo as adjunctive treatment to an assigned
      open-label marketed antidepressant therapy (ADT) in patients with Major Depressive Disorder.
    


Intervention name(s): Brexpiprazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, Oral, once daily, 14 weeks; Tablets, Oral, once daily, 14 weeks
Other intervention name(s): REXULTI
Intervention MeSH terms: Brexpiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Motor_Control_Neck_SSED
Condition: Neck Pain; Forward Head Posture
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Neck pain is a common problem in the western world. There is a group of people suffering from
      neck pain with a reduced ability to maintain an upright posture showing a forward head
      position and an altered muscle function.

      The aim of the study was to evaluate a motor control intervention for patients with
      persistent neck pain and a forward head posture.

      This pilot study used a Single System Experimental Design (SSED) with an A-B-A-design and
      multiple baselines.

      The tailored motor control intervention addressed the faulty postural alignment and the deep
      muscles of the cervical spine.
    


Intervention name(s): Motor control intervention of head posture
Intervention type(s): Behavioral
Intervention description(s): The tailored motor control intervention used for motor learning-procedure described by Fitts and Posner, further developed and adapted to rehabilitation of the spine by O´Sullivan.
The stages involved in the process was the Cognitive stage, Associative stage and the Autonomous stage
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: neck pain; motor control; intervention; forward head posture
Selective Activation of the Infraspinatus During External Rotation Exercises in Participants With Rounded Shoulder Posture
Condition: Shoulder Disease
Study type: Observational

Summary: 
      The purpose of this prospective, cross-sectional study was to evaluate the selective
      activation of the infraspinatus during external rotation exercises in participants with
      rounded shoulder postures and compare the different exercise positions. The fifteen (7 males
      and 8 females) participants with rounded shoulder posture were recruited for this study. The
      EMG activations of the middle trapezius, posterior deltoid and infraspinatus muscles in the
      dominant limb were recorded during exercises in standing external rotation (SER), side-lying
      position (SDER), scapular plane (SPER) and muscle architecture-based (MABER) positions.
    


Intervention name(s): The EMG activations
Intervention type(s): Device
Intervention description(s): The EMG activations of the middle trapezius, posterior deltoid and infraspinatus muscles in the dominant limb were recorded during exercises in standing external rotation (SER), side-lying position (SDER), scapular plane (SPER) and muscle architecture-based (MABER) positions
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Fifteen (7 males and 8 females) participants without shoulder pain, totally able to perform
        overhead activities with no pain or discomfort, without a history of shoulder injuries, and
        with rounded shoulder posture were recruited for this study.
      
Keywords: Infraspinatus; Muscle architecture; Rounded Shoulder Posture; Superficial EMG
Dose-Response Study to Evaluate the Effect of BKR-017 on Insulin Resistance and Other Metabolic Parameters in Type 2 Diabetes Patients
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional

Summary: 
      This study is a randomized, double-blind, placebo-controlled, dose-response study of BKR-017
      and placebo that will be conducted at two investigative sites. The total duration of subject
      involvement is approximately 15 weeks; the screening period can be up to 3 weeks prior to the
      start of test period, followed by a 12-week test period. During the test period, subjects
      will self-administer three tablets of test product, two times daily: before breakfast and
      before bedtime.
    


Intervention name(s): BKR-017
Intervention type(s): Dietary Supplement
Intervention description(s): Nutrient butyrate into a colon-targeted tablet formulation (BKR-017) is intended to stimulate secretion of GLP-1 from L-cells in the lower gut. Butyrate delivered to the colon in tablet form will not cause the side-effects seen with formation of butyrate by fermentation.
Other intervention name(s): Butyrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Dorsovolar Kinesiotape in Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome Treatment
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      This study aimed to compare the short- and medium-term efficacy of dorso-volar kinesiotape
      (KT) added to home exercises (HE) with sham-KT and HE alone in the treatment of mild or
      moderate carpal tunnel syndrome (CTS) in terms of pain, symptom severity, function, grip
      strength, and electrophysiological parameters.
    


Intervention name(s): kinesiotape; home exercises
Intervention type(s): Other; Other
Intervention description(s): The button hole technique was used for area correction during the KT application (Figure 1). Two I-tapes were applied, one from the medial epicondyle to the proximal phalanx on the palmar side and the other from the lateral epicondyle to the proximal phalanx on the dorsal side. The area where the phalanges are located was marked, and two hole was drilled in the center.After cleaning the skin with alcohol, the tape to be applied to the palmar side was passed over the 3rd and 4th fingers, and the patient was asked to perform radial deviation and wrist extension; home exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: carpal tunnel syndromes; kinesiotape; electromyography; median neuropathy; muscle strength; pain
Ghrelin Levels in Early IVF Pregnancies
Condition: Pregnancy
Study type: Observational

Summary: 
      In this study, we have assessed the potential prognostic value for gestational outcome of
      maternal ghrelin levels at very early stages of IVF pregnancies. In addition, ghrelin
      responses to meal intake were explored at early gestation.
    

Detailed description: 
      Ghrelin is a pleiotropic hormone recently involved in the control of growth and metabolism,
      whose circulating levels fluctuate in relation to food intake and body mass index. Ghrelin
      has been detected in the decidualized endometrium, as well as in human and rat placenta, with
      a distinctive temporal pattern of expression along pregnancy.

      Comparison(s): A total of 106 patients undergoing IVF procedures were prospectively
      recruited. On d-16 and 23 after oocyte retrieval, the patients were subjected to blood
      sampling after overnight fasting, for determination of serum ghrelin, hCG and progesterone
      levels. In addition, ghrelin levels were assayed in these groups, 2-h after ingestion of a
      fixed-calorie meal.
    

Time perspective: Prospective
Keywords: Ghrelin; Pregnancy outcome
Correlation Research of Thioredoxin Reductase in Lung Cancer
Condition: Non-small Cell Lung Cancer; Benign Neoplasm of Lung
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplasms
Study type: Observational

Summary: 
      In pre-clinical study the investigators found that the thioredoxin reductase activity of
      serum harbours huge difference between cancer patients and non-cancer patients, the enzyme
      activity elevated remarkably among cancer patients, so the investigators hypothesis that this
      is due to tumor cells loading of the patients, the enzyme activity may harbours huge
      difference between carcinoma tissues and para-carcinoma tissues in early staged non-small
      cell lung cancers, and after surgery, the enzyme activity may fall down to a normal level
      because of removing of tumor.
    

Detailed description: 
      This is a cooperative research project in Thoracic Surgery Department and Medical Oncology
      Department of Affiliated Cancer Hospital of xiangya School of Medicine Central South
      University, and the State Key Laboratory for Natural Medicine and Biomimetic Drugs Perking
      University. The primary objective is to measure the thioredoxin reductase activity using
      blood and lung cancer tissue and measure thioredoxin reductase messenger ribonucleic acid
      (mRNA) and protein expression using lung cancer and pericarcinomatous tissue in early
      staged(Ⅰ~ⅢA) non-small lung cancers, to study the correlations of thioredoxin reductase
      between blood and tissue. The secondary objectives are to measure the thioredoxin reductase
      activity between non small lung cancers and lung benign lesion patients to identify the
      difference between tumor and lung benign mass.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with early staged NSCLC and lung benign lesion Patients show resectable lung mass
        in CT scan, suspected lung cancer and receive surgery in Affiliated Cancer Hospital of
        Xiangya School of Medicine Central South University
      
Biospecimen description: 
      tumor tissue and lung benign mass are obtained in surgery, and blood serum before surgery and
      3-5 days after surgery, blood should be taken and centrifuged then stored at -20 degree,
      tumor tissue and lung benign mass should be stored at -180 degree within 5 mins during
      surgery.
    
Keywords: thioredoxin reductase; non-small cell lung cancer
A Study to Examine the Implantation Characteristics of Two Drug-Eluting Stents
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      Despite recent advances in stent technology and clot reducing drug therapy, acute stent
      occlusion or thrombosis (ST), still occurs and can be life threatening. It has been shown
      that certain features of how the stent relates to the artery wall may predict ST. One such
      feature, so-called stent strut malapposition (SSM), can be assessed after implantation but
      current imaging techniques are relatively unreliable. Optical Coherence Tomography (OCT) is a
      newer technology that can be performed safely and easily after angioplasty and may allow the
      stent struts to be assessed more accurately and reliably.

      This study will use OCT to examine how two different types of commonly used drug-eluting
      stents relate to the artery wall. The Xience V (Abbott Vascular, USA) stent has thinner
      struts and a more open frame than the Cypher (Cordis, USA) stent. We hypothesise therefore
      that the potentially more pliable structure of the Xience V stent will be associated with
      greater contact with the vessel wall. This may have a bearing on the relative rate of SSM,
      although large studies have shown the rate to be low in both the Cypher and the Xience V
      stent. We believe that OCT imaging of SSM and symmetry of the stent immediately after
      angioplasty will compliment conventional visual assessment and may identify those patients in
      whom further improvement of stent with a balloon is necessary.

      This study will involve the random allocation of forty patients requiring coronary
      angioplasty to one of the Cypher or Xience V stent. The procedure will be performed in the
      usual manner as indicated clinically and will include imaging of the stented artery segment
      with OCT once the operator is satisfied with the visual result by angiography.
    


Intervention name(s): Coronary Stent Cypher; Coronary stent Xience
Intervention type(s): Device; Device
Intervention description(s): The angioplasty will then be performed in a usual fashion in accordance with the operator's discretion and local protocols.; The angioplasty will then be performed in a usual fashion in accordance with the operator's discretion and local protocols
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Percutaneous Coronary Intervention; Coronary Artery Stenosis; Acute Myocardial Infarction; Coronary Artery Stent; Optical Coherence Tomography
Safety and Efficacy of Solithromycin in the Treatment of Nonalcoholic Steatohepatitis Without Cirrhosis
Condition: Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effects of solithromycin on hepatic histology
      and biomarkers in patients with nonalcoholic steatohepatitis.
    

Detailed description: 
      Patients will be administered solithromycin for 13 weeks with regular safety visits and liver
      biopsies at baseline and after treatment.
    

Intervention name(s): solithromycin
Intervention type(s): Drug
Other intervention name(s): CEM-101
Intervention MeSH terms: Solithromycin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NASH; Liver disease