bioihbjkbjnl/mcl2 huggingface dataset:
Intramedullary Femoral Reaming, Human Study
Condition: Pulmonary Complications; Organ Failure; Systemic Inflammatory Response Syndrome
MeSH terms: Systemic Inflammatory Response Syndrome
Study type: Interventional

Summary: 
      To what extent the cardiopulmonary and inflammatory response is affected by initial femoral
      intramedullary nailing in the already traumatized and inflammatory activated patient was
      analyzed in the present study with the attention to survey the additional burden of this
      operative treatment. The patients are monitored with a pulmonary catheter, and blood samples
      for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and
      postoperatively. The study is partly randomized 1)where delayed intramedullary nailing is
      compared with primary nailing of the femur, and 2) a new reaming technique (RIA) is compared
      with a standard reaming technique (TR).
    

Detailed description: 
      To what extent the cardiopulmonary and inflammatory response is affected by initial femoral
      intramedullary nailing in the already traumatized and inflammatory activated patient was
      analyzed in the present study with the attention to survey the additional burden of this
      operative treatment. The patients are monitored with a pulmonary catheter, and blood samples
      for coagulation, fibrinolysis, complement and cytokine response are withdrawn pre-, per- and
      postoperatively. The study is partly randomized 1)where delayed intramedullary nailing is
      compared with primary nailing of the femur, and 2) a new reaming technique (RIA) is compared
      with a standard reaming technique (TR).
    

Intervention name(s): the effect of delayed intramedullary reaming; the reaming of the femoral canal is performed with two different reaming devices
Intervention type(s): Procedure; Procedure
Intervention description(s): in one group intramedullary reaming and nailing is performed immediately, femoral fractures in the second group are external fixated and than secondary nailed.; the reaming of the femoral canal is performed with two different reaming devices; a traditional reamer (TR)and the reamer-irrigator-aspirator (RIA)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: intramedullary reaming; inflammatory response; human; femoral shaft fracture; Reamer-irrigator-aspirator
Efficacy and Tolerance of a Follow-On Formula Fed to Children From 12-48 Months of Age in Salvador, Bahia, Brazil
Condition: Acute Respiratory Infection; Diarrheal Disease
MeSH terms: Respiratory Tract Infections
Study type: Interventional

Summary: 
      The purpose is to determine if the consumption of study product has an effect on acute
      respiratory infections and/or diarrheal disease.
    


Intervention name(s): Cow's milk; Follow-On Formula
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Powdered Whole Cow's Milk; Powdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Mentalization-based Training for Adolescents With Conduct Disorder (MBT-CD)
Condition: Conduct Disorder
MeSH terms: Conduct Disorder
Study type: Interventional

Summary: 
      A feasibility and pilot trial to investigate the feasibility of a newly manualized
      psychotherapy "Mentalization-Based Training for Adolescents with Conduct Disorder (MBT-CD)"
    

Detailed description: 
      Background: Conduct Disorder is a severe and complex mental disorder with the highest
      incidence in adolescence. Previous studies have shown that family-oriented interventions are
      effective in the treatment of Conduct Disorder. However, most therapies focus rather on
      symptom management and less on etiological causes without inclusion of the family in the
      therapeutic process. Previous research has linked specific symptoms of Conduct Disorder with
      deficits in mentalization ability. Mentalization is the ability to perceive one's own and
      other's behavior as the product of affective and cognitive mental states. Low or missing
      mentalization abilities are regarded as a risk factor for the development and chronification
      of Conduct Disorder.

      Aims: The study aims to investigate the feasibility of a newly manualized psychotherapy
      "Mentalization-Based Training for Adolescents with Conduct Disorder (MBT-CD)" that strives to
      decrease symptoms associated with Conduct Disorder by increasing mentalization in adolescents
      and their families.

      Methods: The study is feasibility and piolot trial, carried out in Heidelberg (Germany), and
      Mainz (Germany). Adolescents aged between 11-18, who meet the DSM-5 criteria for Conduct
      Disorder will receive MBT-CD. Times of measurement: t0 (Screening), T1 (Baseline, at the
      beginning of therapy), T2 (3 months after the beginning of therapy), T3 (at the end of
      therapy, after 6 months), T4 (follow-up, after 9 months).
    

Intervention name(s): MBT-CD
Intervention type(s): Other
Intervention description(s): MBT-CD is a disorder-specific modification of MBT, initially developed for patients with Borderline Personality Disorder. It is a manualized and psychodynamically oriented psychotherapy with the aim to increase the mentalization capacity of adolescents in close relationships. The therapy consists of 2 psychoeducational group sessions, 30 individual therapy sessions and 10 family sessions. The average duration of therapy is 6 months.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mentalization-based treatment; conduct disorder; adolescents
S9304A Study of Protein Expression in Tumor Tissue Samples From Patients With Stage II or Stage III Rectal Cancer Enrolled in Clinical Trial SWOG-9304
Condition: Colorectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may
      help doctors learn more about changes that occur in DNA and identify biomarkers related to
      cancer. It may also help doctors predict how patients will respond to treatment.

      PURPOSE: This research study is looking at protein expression in tumor tissue samples from
      patients with stage II or stage III rectal cancer enrolled in clinical trial SWOG-9304.
    

Detailed description: 
      OBJECTIVES:

        -  Determine expression levels of thioredoxin-1 (Trx-1), thioredoxin-interacting protein
           (TXNIP), and hypoxia inducible factor-1 alpha (HIF-1α) in paraffin-embedded resected
           tumor tissue samples from patients with stage II or III rectal cancer enrolled in
           clinical trial SWOG-9304.

        -  Determine if there is a correlation between Trx-1 and TXNIP expression and HIF-1α
           expression.

        -  Correlate expression of these proteins with tumor stage, disease-free survival, overall
           survival, and risk of recurrence.

        -  Determine interactions for patient age, performance status, and type of therapy received
           on clinical trial SWOG-9304.

      OUTLINE: This is a multicenter study.

      Paraffin-embedded resected tumor tissue samples are analyzed for protein expression levels
      (thioredoxin-1, thioredoxin-interacting protein, and hypoxia inducible factor-1 alpha) by
      tissue microarray and immunostaining.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients enrolled on SWOG-9304, adenocarcinoma of the recturm Stage II or III
      
Keywords: stage II rectal cancer; stage III rectal cancer; adenocarcinoma of the rectum
Comparative Study of the Bioavailability of Magnesium Administrated by Two ChronoMag Smart Tablet® 50 mg Versus Three Mag2® Tablets 100mg.
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical study is composed of two steps. The first step aims at validating the
      pharmacokinetic approach based on the magnesium concentration in erythrocyte and plasma.

      According to these results and if this pharmacokinetic approach is validated, the second step
      will set up. The second phase aims at comparing the relative bioavailability of magnesium
      administrated by two different drug formulations: ChronoMag Smart Tablet® (two tablets50mg)
      versus Mag2® (three tablets100mg).
    

Detailed description: 
      " Go/no go " comparative biodisponibility study. Randomised, cross-over, controlled and
      double-blind, monocentric study in healthy volunteers.
    

Intervention name(s): Magnesium chloride (ChronoMag Smart Tablet®); Magnesium carbonate (Mag2® Tablet)
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Bioavailability of magnesium; Digestive and general tolerance
Treatment Response of Maintenance Dose of Proton Pump Inhibitor in Patients With Nonerosive Gatroesophageal Reflux Disease
Condition: Non-erosive Gatroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional

Summary: 
      For ERD(erosive reflux disease), which pathogenesis is mainly the acid reflux mechanism,
      primary treatment is therefore PPI. However, NERD(non-erosive reflux disease) is much more
      complex than ERD and there are more factors causing the typical symptoms. As a result, there
      is no consensus for the treatment of NERD besides using PPI similar to GERD(gastroesophageal
      reflux diseas). This study intent to evaluate the effect of PPI(Esomezol) on NERD patients
      and analyze the improvement of symptoms and the factors related to the result.
    

Detailed description: 
      (1) Among GERD patients, EGD(esophagogastroduodenoscopy) must be done before 6 months and
      must prove there is no erosive lesion. (2) During EGD, esophagus mucosa histology will be
      taken for evaluation. (3) For NERD patients, Esomezol is given once a day (before breakfast
      meal), for whole 8 weeks. (4) PAGI-SYM and HAD-K is evaluated and score just before the
      administration of PPI, 4weeks after and 8weeks after the study initiation.
    

Intervention name(s): PPI
Intervention type(s): Drug
Intervention description(s): After the diagnosis of NERD through patient's symptom and endoscopy, PPI (esomezol) will be given for 8 weeks. The effect of PPI for NERD patients will be analyzed.
Other intervention name(s): Esomezol®
Intervention model: Single Group Assignment
Intervention model description: There is only one arm in this study. Patients diagnosed as NERD will take PPI (Esomezol) for 8 weeks.
Masking: None (Open Label)
Primary purpose: Treatment
Omega-3 Fatty Acids, the Omega-3 Index, and Atherosclerosis
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional

Summary: 
      An increase in intake of omega-3 fatty acids should increase the Omega-3 Index. Current
      evidence indicates that this may lead to a reduction in risk for sudden cardiac death and
      atherosclerotic diseases like myocardial infarction. The aim of the study is to investigate,
      how supplementing a convenience drink with omega-3 fatty acids influences the Omega-3 Index,
      as compared to an unsupplemented matching convenience drink. Palatability and safety of the
      drink are also to be assessed.
    


Intervention name(s): 500 mg eicosapentaenoic (EPA) plus docosahexaenoic acids (DHA); Control convenience drink
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Composition of active convenience drink (smartfish): 200 ml drink, enriched with 940 mg omega-3 fatty acids, of which 200 mg are EPA, 300 mg DHA and 100 mg DPA, slightly carbonized..
Energy content 486 kJ (116 kcal), protein 0.6 g, Carbohydrates 22 g, total fat 4 g, of which 0.6 g saturated fatty acids, 1.8 g monounsaturates, 1.4 g polyunsaturates. Vitamin D 0.85 ug.
Control convenience drink: as above, containing about 1 g Omega-6 fatty acids from e.g. corn oil.; Control convenience drink: as above, containing about 1 g Omega-6 fatty acids from e.g. corn oil.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Omega-3 fatty acids; dietary supplementation; atherosclerosis
Assess the Influence of a High-fat Meal on the Relative Bioavailability Of Two Formulations of Risedronate
Condition: Bioavailability
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open-label, multi-center, 4-treatment, 4-period crossover study.
      Approximately 72 healthy, surgically sterile or postmenopausal subjects will be enrolled and
      have urine collected over 72 hours following administration of risedronate for all 4
      treatment periods).
    


Intervention name(s): Risedronate; Risedronate; Risedronate; Risedronate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Treatment A (35 mg DR Fasted): One risedronate tablet (35 mg DR) taken following an overnight (10-hour) fast, followed by a 4-hour fast.; Treatment B (35 mg DR Fed): One risedronate tablet (35 mg DR) taken following an overnight (10-hour) fast, within 5 minutes after ingesting a high-fat meal.; Treatment C (35 mg IR Fasted): One risedronate tablet (35 mg IR) taken following an overnight (10-hour) fast, followed by a 4-hour fast.; Treatment D (35 mg IR Per-label): One risedronate tablet (35 mg IR) taken following an overnight (10-hour) fast, 30 minutes before ingesting a high-fat meal.
Intervention MeSH terms: Risedronic Acid; Etidronic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Efficacy of Intensified Transcranial Direct Current Stimulation in Obsessive-compulsive Disorder
Condition: Obsessive-Compulsive Symptom
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, parallel-group, sham-controlled trial that aims to
      investigate the effectiveness of transcranial direct current stimulation (TDCS) on improving
      symptoms, quality of life, depression, and cognitive functions in 39 patients with
      obsessive-compulsive disorder (OCD) that are randomized in 3 experimental groups.
    


Intervention name(s): transcranial direct current stimulation
Intervention type(s): Device
Intervention description(s): Patients will receive 10 sessions of 20 minutes of either 1 mA, 2 mA or sham electrical stimulation on 5 consecutive days
Other intervention name(s): tDCS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of Biomechanical Scapular Mobilization With Movement and Motor Learning
Condition: Shoulder Impingement Syndrome
MeSH terms: Shoulder Impingement Syndrome
Study type: Interventional

Summary: 
      the study about new mobilization technique used in shoulder impingement syndrome patient to
      increase the range of motion of elevation, decrease the pain, and increasing the function
      level, this technique is based on normal mechanics that occur inside the joint during certain
      movement.
    

Detailed description: 
      The study is about a new technique of mobilization based on normal biomechanics that occurs
      during the movements of a joint. For example, shoulder abduction or elevation needs the
      scapula to move upward rotation with posterior tilt and external rotation. Moreover, needs
      glenohumeral (GH) joint glide inferior and posterior these movements occur normally to permit
      us to elevate our shoulder without any restriction and the full range of motion(ROM). so in
      the patients with shoulder problems and have difficulties reaching full ROM of elevation the
      investigators applied mobilization of scapula toward upward rotation with external rotation
      and posterior tilt and by using mobilization belt applied posterior and inferior glide to GH
      joint. However, mobilization techniques have a short-term effect to enhance this effect, the
      investigators adding a motor learning approach to achieve a long-term effect and prevent
      recurrent .the investigators applied this technique 3 times per week for 3 weeks.
    

Intervention name(s): biomechanical scapular mobilization with movement and motor learning
Intervention type(s): Other
Intervention description(s): the therapist applied posterior tilt and exteral rotation with upward rotation mobilization to scapula and therapist also warp bilt around GH joint to applied inferior and posterior glid then ask patient to elevate his arm. then we applied motor learning approach by asking patient to elevate his arm with maintaining of external rotation with posterior glid of scapula.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients were divided randomly in two equal groups (A and B): Group A (controlled group):
They were received traditional physical therapy program including: passive range of motion (PROM)/ active assisted range of motion (AAROM)/ active range of motion (AROM), strengthen of rotator cuff, biceps, shoulder and scapular muscles, ultrasound (5 min. - 1.5 W/c.m2 - 1 MHZ), electrical stimulation ( interferential bipolar technique for 20 min. on shoulder joint). Group B (study group): they have received the same physical therapy program as in group A, in addition to Biomechanical scapular mobilization with movement and motor learning.
Masking: None (Open Label)
Primary purpose: Treatment
A Single Intravenous Dose of E3112 in Japanese Healthy Adult Male Participants
Condition: Healthy Male Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics after
      a single intravenous dose of E3112 in Japanese healthy adult male participants.
    


Intervention name(s): E3112; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Intravenous infusion.; Intravenous infusion.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: E3112; Phase 1; Pharmacokinetics; Japanese
A Study to Evaluate GBT021601-012 Single Dose and Multiple Dose in Participants With Sickle Cell Disease (SCD)
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK),
      and pharmacodynamics (i.e., how the body absorbs, distributes, breaks down, and excretes) of
      GBT021601, a hemoglobin S (HbS) polymerization inhibitor, in participants with SCD, following
      single and multiple ascending doses.
    

Detailed description: 
      This is an open-label intrapatient single dose followed by a multiple dose escalation study
      in at least six (6) participants with SCD.
    

Intervention name(s): GBT021601
Intervention type(s): Drug
Intervention description(s): Tablets and capsules which contain GBT021601 drug substance
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Motor Control in Chronic Fatigue Syndrome and Fibromyalgia
Condition: Fibromyalgia; Chronic Fatigue Syndrome
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Fatigue Syndrome, Chronic; Syndrome; Fatigue
Study type: Observational

Summary: 
      This project is a comprehensive study, with main focus on motor control, comparing patients
      with chronic fatigue syndrome / myalgic encephalopathy (CFS/ME) and/or fibromyalgia syndrome
      (FMS). Focus of the present project will be on detailed movement analysis in a movement
      laboratory and involve functional tasks such as walking and standing. Investigations will
      also comprise muscle activity, reaction time and fine motor control.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with chronic fatigue syndrome and fibromyalgia from primary care clinics.
      
Keywords: Motor control; walking; physical activity; Muscle activity
Bilateral Brain Dynamics in Cognition and Aging
Condition: Alzheimer Disease; Aging; MCI
MeSH terms: Alzheimer Disease
Study type: Observational

Summary: 
      This project is focused on the gap in understanding of bilateral brain interactions and their
      role in helping normative and clinical elderly populations maintain cognitive health. The
      investigator will focus on investigating this neural mechanism of these interactions and
      promoting them with a precise application of TMS, in order to test the hypothesis that
      excitatory interactions between the hemispheres can provide positive outcomes for patients
      with pre-clinical AD (amnestic Mild Cognitive Impairment or MCI-AD). In Session 1, the
      investigator will establish the spatial specificity of bilateral brain mechanisms with
      combination of behavior, TMS, and structural neuroimaging in cortical sites known to be
      active during memory encoding. In Session 2, the investigator will establish the underlying
      dynamics of interhemispheric communication using a novel combination of TMS and
      electroencephalography (EEG) to establish the coordinated activity between the hemispheres;
      Lastly, in Session 3, the investigator will use the TMS entraining parameters delineated in
      Aim 2 to promote specific cross-hemispheric communication, applied to participants performing
      a Picture Encoding task, a general task of memory performance. The outcome of these studies
      will allow our group to evaluate the strength of this brain stimulation protocol in
      alleviating age-related and dementia-related cognitive decline, and enable development of
      novel treatment protocols for dementia in elderly cohorts.
    


Intervention name(s): TMS
Intervention type(s): Device
Intervention description(s): A multimodal approach consisting of single pulse TMS, dual-coil TMS, and EEG will be used to examine whether synchronous hemispheric interactions associated with TMS will be present in weighted phase-lag coherence (WPLI), if these measures will be enhanced by in-phase TMS and reduced by counter-phase TMS, and if WPLI will be greater for normal controls than MCI-ADs.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants will be recruited from the Duke Bryan Alzheimer's Disease Research Center
        Alzheimer's Disease Prevention Registry (ADRC ADPR). Thirty healthy volunteers and thirty
        MCI-ADs will be recruited.
      
Biospecimen description: 
      Saliva samples were collected on a subset of participants who consented to this additional
      study component.
    
Keywords: Alzheimer's Disease; AD; MCI-AD; MCI; Memory; TMS; Transcranial Magnetic Stimulation; Neuropsychological evaluation; MRI; DTI; EEG