bioihbjkbjnl/mcl2 huggingface dataset:
Interaction Between Trunk and Gait Performance in Both Healthy Adults and Stroke Patients
Condition: Stroke; Healthy; Gait, Hemiplegic
MeSH terms: Stroke; Gait Disorders, Neurologic
Study type: Observational

Summary: 
      The aim is to investigate the biomechanical interaction between trunk and gait performance in
      both healthy and stroke subjects. People after stroke often have an impaired trunk function,
      resulting in balance and gait disorders. Pathological movement patterns after stroke can be
      compared with normative data as motion capture systems provide more sensitive data to explore
      the interaction between trunk performance and gait in contrast to the clinical measures used
      in literature.
    

Detailed description: 
      Evidence has shown that trunk performance is related to measures of balance, gait and
      functional ability. Yet, several aspects of trunk performance such as sitting balance, trunk
      muscle strength, selective trunk movements and trunk position sense are impaired after
      stroke. This implies that impaired trunk performance will inevitably lead to impaired
      postural control during activities performed while standing and walking. Nonetheless, the
      interaction between increased trunk performance and improvements in activities performed
      while standing and walking is not evident. It has previously been stated that therapy
      primarily induces treatment effects on the abilities at which training is specifically aimed.
      However, previous research has shown that additional trunk exercises improve not only trunk
      performance but also standing balance and mobility. Yet, the clinical outcome measures used
      in previous studies are not suitable to explore the relationship between trunk and gait
      performance and cannot explain the underlying mechanisms of the therapeutic effects. Since
      studies using sensitive motion analyses to investigate trunk biomechanics during gait are
      sparse in both healthy subjects and subjects with stroke. Data will be gathered by a Vicon
      analysis system (©Vicon Motion Systems Ltd., London, UK) with a measuring frequency of 100 Hz
      and eight infrared automated cameras (Vicon T10 cameras, 100 fps, 1 Megapixel) measured the
      3D coordinates of the reflective markers. In addition, initial contact and toe off were
      defined based on the ankle trajectories of the reflective markers together with 3 AMTI type
      OR 6-7 force plates (1000 fps, 46x50x8 cm) and 1 AccuGait® (1000 fps) force plate recordings.
      Reflective motion trackers were attached to anatomical landmarks on the participant's body
      according to the standard Plug-In-Gait model. Furthermore, a 16 channel telemetric wireless
      EMG system (Arion Zerowire) will measure muscle activity.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy Volunteers: community sample Stroke: Rehabilitation Hospital RevArte, primary care
        clinic
      
Keywords: Torso; Trunk
A Randomized Control Trial Comparing Quetiapine to Risperidone in Bipolar Disorder With Stimulant Dependence
Condition: Bipolar Disorder; Cocaine Dependence; Methamphetamine Dependence
MeSH terms: Cocaine-Related Disorders; Bipolar Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether quetiapine or risperidone are effective in
      treating mood symptoms, drug cravings and use in bipolar disorder with concurrent cocaine or
      methamphetamine dependence.
    

Detailed description: 
      Bipolar disorder may be associated with the highest rates of substance abuse of any
      psychiatric illness. Studies suggest that substance abuse in persons with bipolar disorder
      have lifetime prevalence rates as high as 60% with reports of cocaine abuse as high as 30%.
      Comorbid substance abuse in persons with bipolar disorder is associated with increased
      hospitalization, poorer psychiatric recovery and treatment response than in patients with
      bipolar disorder alone. Thus, therapeutic agents that may enhance prognosis by improving
      psychiatric outcomes, reducing stimulant cravings, and increasing treatment retention are of
      considerable interest. In a previous study conducted in this lab, we found that conventional
      neuroleptic agents were associated with an increase in depressive symptoms and a significant
      increase in stimulant cravings. These results mirror preclinical animal data that show
      conventional neuroleptics (i.e.haloperidol) with high dopamine receptor binding affinities
      actually increase cocaine self-administration in rats and monkeys. These results are
      clinically relevant as persons with bipolar disorder who abuse cocaine and other drugs often
      receive higher doses of conventional neuroleptics than those without cocaine or other drug
      abuse. In contrast to conventional neuroleptic therapy, atypical antipsychotics (i.e.
      quetiapine, risperidone), decrease self-administration of cocaine. The receptor binding
      profile of the atypical antipsychotics broadly vary although all agents in this drug class
      are known as serotonin-dopamine antagonists. Quetiapine has 'moderate' dopamine binding,
      while risperidone has 'high' dopamine receptor binding properties similar to conventional
      neuroleptic agents. Thus, our hypothesis is that quetiapine may be a more efficacious agent
      than risperidone in treating bipolar mood symptoms while attenuating drug cravings and use.
    

Intervention name(s): quetiapine, risperidone
Intervention type(s): Drug
Intervention description(s): Flexible dose titrations to 'treat-to-symptoms'
Other intervention name(s): Seroquel; Risperdal
Intervention MeSH terms: Risperidone; Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bipolar, cocaine, methamphetamine,quetiapine,risperidone
Drug-Drug Interaction Study in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effects of fluconazole on the pharmacokinetics of
      K 877 in healthy adult subjects.
    


Intervention name(s): K-877; Fluconazole
Intervention type(s): Drug; Drug
Intervention MeSH terms: Fluconazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Adult Volunteers
Evaluation of Patients With Vena Cava Inferior Thrombosis
Condition: Inferior Vena Cava Thrombosis; Venous Thromboembolism
MeSH terms: Thrombosis; Thromboembolism; Venous Thromboembolism
Study type: Observational

Summary: 
      The purpose of the study is to evaluate patients with inferior vena cava (IVC)thrombosis in
      terms of etiology, clinical course and prognosis during long-term follow-up. Patients with
      isolated lower extremity DVT, matched for age and gender, serve as controls.
    

Detailed description: 
      All Patients are assessed using a standardized questionnaire and details concerning VTE risk
      factors, concomitant disease, medical conditions, diagnosis and therapy of IVC thrombosis
      were registered. A blood sample is taken to test for inherited and acquired thrombophilia. In
      addition, duplex ultrasound examination and digital photoplethysmograph are performed to
      assess postthrombotic syndrome.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with venous thrombosis involving the inferior cava inferior obtained from the
        Main-Isar-Thrombosis registry in which all patients seen for venous thromboembolism in our
        department are registered
      
Biospecimen description: 
      Whole blood, serum
A Study of JNJ-61393215 in the Treatment of Depression
Condition: Major Depressive Disorder With Anxious Distress
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of JNJ-61393215 as adjunctive treatment
      compared to adjunctive placebo, as assessed by the change from baseline to week 6 on a
      17-item Hamilton Depression Rating Scale (HDRS-17) in participants with major depressive
      disorder (MDD) with anxious distress with a score greater than or equal to (>=) 2 on item 26
      or 27 of the Inventory of Depressive Symptomatology, Clinician Rating -30 (IDS-C30), who have
      a suboptimal response to current treatment with a standard antidepressant.
    


Intervention name(s): JNJ-61393215; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): JNJ-61393215 will be administrated orally.; Matching placebo will be administered orally.
Other intervention name(s): Orexin-1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Facial Type Determination Through Cephalometry, Anthropometry and Facial Analysis
Condition: Healthy
Study type: Observational

Summary: 
      Introduction:

      Human face with its bony and muscular structures has singular and peculiar characteristics.
      It may be classified in three types, associated with the variation of shape and craniofacial
      configuration, both in vertical and horizontal planes, directly affecting dental occlusion,
      face harmony, orofacial musculature and oral functions. Aim: to correlate cephalometric with
      anthropometric and facial analysis findings on determining the facial type.

      Method:

      105 leukoderm adults were involved, 34 male and 71 female aging between 20 and 40 years old.
      Data were collected in December 2006 in an orthodontic clinic located at Belo Horizonte- MG,
      Brazil. Cephalometric findings to determinate facial types were compared to seven
      anthropometric facial measurements, three anthropometric facial proportions and three
      anthropometric facial indices, in addition to facial type identification through clinical
      facial analysis of photographs.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        primary care orthodontic clinic
      
Keywords: Face; Cephalometry; Anthropometry; Photography; Diagnosis; Adult; Morphology; Comparative Study
Lethal Congenital Malformations: Palliative Therapy From An Islamic Point of View
Condition: Congenital Malformations
MeSH terms: Congenital Abnormalities
Study type: Observational

Summary: 
      To prove that palliative therapy can be practised for congenital lethal malformations within
      the Islamic Code of Ethics.

      After defining lethal malformation no respiratory support is offered and newborns are
      provided with compassionate care.
    

Detailed description: 
      This is a prospective observational study where all abnormal antenatal ultrasounds are
      discussed in a weekly prenatal meeting and plans are drawn for management of these abnormal
      fetal findings. Lethal malformations are defined as conditions which will end in death
      regardless of supportive care. Cases are discussed extensively and parents are involved in
      management decisions. When a decision of non- intervention is reached for a lethal
      malformation consent of the family is obtained and a plan of non monitoring for the mother is
      documented together with no resuscitation for the newborn. Families who do not consent to
      such plan are offered full support for the pregnant mother and her newborn. A record of all
      cases is kept available together with the management plan so that the appropriate action is
      taken when the the pregnant lady presents for admission. All babies with lethal malformations
      are recorded whether stillborn or live born and their diagnosis is confirmed. Survival time
      is recorded for each case.
    

Intervention name(s): Palliative management
Intervention type(s): Other
Intervention description(s): Diagnostic studies for abnormal fetal ultrasounds
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Babies with abnormal fetal ultrasounds and who fall into the definition of lethal
        congenital malformation according to the groups in our study
      
Keywords: Congenital Lethal Malformations
A Parenting and Self-Care Intervention for HIV Infected Mothers
Condition: HIV
Study type: Interventional

Summary: 
      The IMAGE intervention was developed to improve parenting and self-care skills in mothers
      infected with HIV. It is expected that an improvement in these areas will in turn improve the
      mother's physical and mental health as well as the child's mental health and behavioral
      adjustment.
    

Detailed description: 
      Worldwide, close to half the adults living with HIV are women and a large proportion of these
      women are of child-bearing age. Whereas anyone living with HIV faces the physical challenges
      of living with a chronic disease, as well as the material and social impact of the stigma
      associated with the disease, mothers living with HIV must also meet the demands of
      childrearing while mitigating the negative impact of the disease upon their family. Mothers
      with HIV report that this is their greatest source of stress. Moreover, children of these
      mothers, growing up with a parent with a chronic, stigmatized, and often fatal disease, are
      considered a high-risk group. The IMAGE intervention was designed to improve parenting and
      self-care skills in mothers with HIV in order to improve the mother's physical and mental
      health as well as the child's mental health and behavioral adjustment.
    

Intervention name(s): IMAGE Intervention
Intervention type(s): Behavioral
Intervention description(s): Mothers in the intervention will receive four individual intervention sessions with a facilitator. The sessions will cover parenting and self care skills.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: HIV; Parenting; self-care; disclosure; medication adherence; mother; child; adolescent
The Effect of Prebiotics on the Microbiome in Irritable Bowel Syndrome Patients: The Diet and Microbiome Study
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Irritable bowel syndrome (IBS) is a chronic gastrointestinal illness of unknown cause whose
      symptoms include abdominal pain, bloating and altered bowel pattern. Diet has been shown to
      influence the bacteria gut interaction. Our aim is to determine if components of the diet
      affect IBS symptoms by changing the bacteria gut interaction. In particular, we will measure
      whether after being on a diet high or low on certain factors there is a change in the timing
      and amount of hydrogen and methane produced by bacteria digesting lactulose and on IBS
      symptom severity.
    


Intervention name(s): Factor Altered Diet
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diet
Evaluation of Joint Position Sense in Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      The aim of the study was to investigate the validity and reliability of the KForce Sens® for
      the evaluation of wrist joint position sense in individuals with CTS. Wrist joint position
      sense was assessed with KForce Sens® and Baseline® electrogoniometer. The validity and
      reliability of the KForce Sens® for wrist position sense evaluation were investigated by
      comparing the two data sets.
    


Intervention name(s): KForce Sens; Baseline Electrıgoniometer
Intervention type(s): Device; Device
Intervention description(s): The device was attached to the middle of the wrist joint with the help of Velcro for all movements. Starting position of the extremity was determined and this position was introduced to the device as the reference position. Then, the participant was asked to perform the movement.; The pivot point of the goniometer was placed next to the ulnar styloid for 30° and 60° wrist flexion and extension, and also it was placed in the middle carpometacarpal joint for radial and ulnar deviation. A passive movement was made to the extremity in a predetermined amount and direction. The participant was asked to remember this position. Then, the participant was asked to return the extremity to this position when their eyes were closed.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: joint position sense; electrogoniometer; carpal tunnel syndrome
Evaluation of the Efficacy and Safety of Single Dose Tranexamic Acid in Reducing Blood Loss During Colorectal Cancer Surgery
Condition: Colorectal Surgery
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      A total of 46 patients scheduled for explorative laparotomy with the aim of radical debulking
      surgery for colorectal cancer will be randomized into two equal groups one will receive
      tranexamic acid and one placebo.

      The TA group will receive an intravenous bolus of (10 mg/kg) in 100 ml of normal saline over
      20 minutes after induction of anesthesia and before surgical incision. In the control group,
      patients will receive a placebo of 100 mL 0.9% normal saline. The primary endpoint is
      reduction in blood loss, while the secondary endpoint was the number of patients needing
      transfusion and occurrence of postoperative thrombotic complications (myocardial infarction,
      stroke, pulmonary embolism, renal failure, or bowel infarction) within 30 days after surgery.
    


Intervention name(s): Tranexamic Acid Injection; placebo injection
Intervention type(s): Drug; Drug
Intervention description(s): The TA group will receive an intravenous bolus of (10 mg/kg) in 100 ml of normal saline over 20 minutes after induction of anesthesia and before surgical incision; patients will receive a placebo of 100 mL 0.9% normal saline
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: colorectal,blood, transfusion,haemorrhage,tranexamic acid.
Comparison Between Bupivacaine and Bupivacaine- Dexamethasone QLB for Postoperative Analgesia
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to assess the analgesic sparing effect of adding Dexamethasone
      to Bupivacaine in Quadratus lumborum block in patients undergoing Laparoscopic
      cholecystectomy under general anesthesia.
    

Detailed description: 
      Background: The QLB is an effective analgesic technique for various abdominal wall incisions.
      The QLB covers T7 to L2 dermatomes by the spread of LA drugs either into the paravertebral
      space or in the thoracolumbar plane, through iliohypogastric and ilioinguinal nerves, A and C
      fiber nociceptors, mechanoreceptors and high-density network of lumbar sympathetic fibers.

      Objective: To assess the analgesic sparing effect of adding Dexamethasone to Bupivacaine in
      Quadratus lumborum block in patients undergoing Laparoscopic cholecystectomy under general
      anesthesia.

      Patients and Methods: Sixty patients scheduled for elective Laparoscopic cholecystectomy
      surgeries under general anesthesia were included in this study, they were divided into two
      groups. Group A (perineural dexamethasone and bupivacaine group) [n=30] Those cases will
      receive 2ml volume of dexamethasone (8mg) combined with 18 ml of bupivacaine of 0.25%
      concentration. Group B (perineural bupivacaine group) [n=30] Those cases will receive
      perineural 18 ml bupivacaine (0.25%) combined with 2 ml normal saline.
    

Intervention name(s): Bupivacaine; Dexamethasone
Intervention type(s): Drug; Drug
Intervention description(s): 18 ml of bupivacaine of 0.25% injected bilaterally in quadratus lumborum block; dexamethasone
Intervention MeSH terms: Dexamethasone; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: bupivacaine; dexamethasone; quadratus lumborum block
Tolerability and Reactogenicity Trial of the Recombinant Tuberculosis Allergen in Healthy Volunteers
Condition: Tuberculosis; Skin Tests
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective of the trial is to study the safety and tolerability of the Recombinant
      tuberculosis allergen in standard dilution in healthy volunteers after a single dose.

      Additional trial purpose: evaluation of the product reactogenicity.
    

Detailed description: 
      The trial product is an Intradermal test to diagnose tuberculosis infection and
      nontuberculosis mycobacteriosis in combination with other methods. The trial will include 2
      stages (stage I, II). At stage I 5 healthy volunteers will be consequently included in each
      group to evaluate tolerance and reactogenicity. Time required to evaluate the tolerance and
      reactogenicity for the first 5 volunteers in each group is less than 3 days. If no SAEs which
      have a "possible", "probable" and "definite" causal relationship with the product
      administration are observed in more than three volunteers from each group, the remaining
      volunteers will be allowed to take part in the trial. At stage II 20 healthy volunteers will
      be included in each group. Each volunteer will be assigned a two-digit randomization number.
    

Intervention name(s): Mycobacterial recombinant allergens 0.1 μg; Mycobacterial recombinant allergens 0.2 μg; Placebo
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): solution for intradermal injection, 0.1 µg / 0.1 mL; solution for intradermal injection, 0.2 µg / 0.1 mL; solution for intradermal injection
Other intervention name(s): Recombinant tuberculosis allergen in standard dilution; Recombinant tuberculosis allergen in standard dilution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Tuberculosis; Diagnosis; Recombinant Tuberculosis Allergen; Mycobacterial recombinant allergens; Allergen; SPbSRIVS
The Effect of Azithromycin on BCT197 Exposure in Healthy Male Volunteers
Condition: Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label, single-sequence study to evaluate the effect of azithromycin on BCT197
      exposure in healthy male subjects.
    

Detailed description: 
      This will be an open study conducted in healthy male subjects at a single centre. Each
      subject will participate in a screening visit and 2 study periods. At the first study period,
      all subjects will receive a single dose of BCT197 and at study period 2, all subjects will
      receive 3 daily doses of azithromycin and a single dose of BCT197.
    

Intervention name(s): BCT197; Azithromycin
Intervention type(s): Drug; Drug
Intervention description(s): A single dose of BCT197; 3 daily doses of Azithromycin
Other intervention name(s): Acumapimod
Intervention MeSH terms: Azithromycin; Acumapimod
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Male volunteers