bioihbjkbjnl/mcl2 huggingface dataset:
The Closed Kinetic Chain Lower Extremity Stability Test (CKCLEST): A New Clinical Performance Test
Condition: Healthy
Study type: Interventional

Summary: 
      It becomes important to evaluate closed kinetic chain activity. The aim of this study was to
      develop and to determine the test-retest, intra- and interreliability, and validity of the
      Closed Kinetic Chain Lower Extremity Stability Test (CKCLEST).
    

Detailed description: 
      Closed kinetic chain activities and exercises are used more and more in rehabilitation
      programs as they take place in daily life as functional movements. Therefore, it becomes
      important to evaluate closed kinetic chain activity. The aim of this study is to develop and
      to determine the test-retest, intra- and interreliability, and validity of the Closed Kinetic
      Chain Lower Extremity Stability Test (CKCLEST). Three-blinded, cross-sectional,
      repeated-measures clinical measurement reliability trial. To assess the reliability of
      CKCLEST, intraclass correlation coefficient (ICC), standard error of measurement (SEM),
      minimal detectable change (MDC), and Bland-Altman plot will be used. For concurrent validity
      of CKCLEST will be applied Spearman correlation analysis with Vertical Jump Test, Isokinetic
      Dynamometer Test, Single Leg Hop Test, and Prone Bridge Test. All analyses were made for both
      the best score and the average score. This test allows the evaluation of functional lower
      extremity stability, static/dynamic control of the lower extremity (knee/hip) or trunk, and
      simultaneous activation of the quadriceps and hamstring muscles / such coactivation.
    

Intervention name(s): Some clinical evaluation performance tests together with procedure of Closed Kinetic Chain Lower Extremity Stability Test
Intervention type(s): Procedure
Intervention description(s): Clinical evaluation methods
Other intervention name(s): Vertical Jump Test; Isokinetic Dynamometer Test; Single Leg Hop Test; Prone Bridge Test
Intervention model: Single Group Assignment
Intervention model description: Three-blinded, cross-sectional, repeated-measures clinical measurement reliability trial
Masking: None (Open Label)
Primary purpose: Other
Keywords: Endurance; Lower limb; Performance test; Power; Reliability and Validity; Strength
Maternal Adipose Tissue and Placental Dysfunction Programs the Fetus for Type 2 Diabetes (PlacentA-DM)
Condition: Obesity; Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The purpose of this study is to discover the characteristics of pregnant women which
      increases risk for their babies to develop diabetes, later on in life.
    

Detailed description: 
      Obesity has been recently diagnosed in a younger population and currently in the United
      States more than two thirds of women of childbearing age are overweight or obese. These women
      will have children at high risk for developing obesity and Type 2 diabetes (T2DM). There is
      an acute need for preventing these complications in children so that we can break the cycle
      of obesity and T2DM. Numerous interventions have attempted but failed to improve outcomes in
      obese pregnancies by weight loss. Clinicians do not currently have specific recommendation
      for identifying the obese mothers and risk and for the prevention of infant's complication in
      healthy obese pregnancies.

      The global objective of this study is to identify the relevant maternal phenotype at risk and
      the mechanism(s) of fetal environment predisposing the offspring for T2DM. This will enhance
      T2DM early screening and prevention.

      The global hypothesis is that dysfunctional adipose tissue secretes angiostatic and
      pro-inflammatory factors that lead to the formation of a dysfunctional placenta, which
      through a hypoxic and inflamed environment alters the epigenome to program the fetus for
      T2DM.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Vulnerable populations- Pregnant Women, Fetuses and Neonates

        Propose to study pregnant women in order to determine the relevant phenotype with offspring
        at risk for obesity and T2DM.
      
Biospecimen description: 
      Blood Adipose tissue Placental tissue Umbilical Cord tissue Umbilical Cord blood
    
Keywords: adipose tissue; placenta; pregnancy; umbilical cord
A Phase I Study Evaluating SCB-313(Recombinant Human TRAIL-Trimer Fusion Protein) for the Treatment of Malignant Pleural Effusion
Condition: Malignant Pleural Effusion
MeSH terms: Pleural Effusion, Malignant; Pleural Effusion
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and tolerability of single dose of SCB-313 by intrapleural
      injection.To evaluate the safety and tolerability of repeated dose of SCB-313 by intrapleural
      injection once a day for 3 days, and to determine the maximum tolerated dose (MTD) of
      SCB-313.
    


Intervention name(s): SCB-313
Intervention type(s): Drug
Intervention description(s): SCB-313 Intrapleural injection, once daily. Single dose on Day 1 in Cycle 0 followed by 7-day safety assessment, then dose on Day 1,2,3 in Cycle 1 followed by 21-day observation .
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Sucrose on Liver Fat
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      AIMS To determine the effect of high and low sucrose diets on liver fat in healthy adult men
      with liver fat levels below 5%
    

Detailed description: 
      DESIGN Randomized, cross-over design with two 7-day dietary interventions separated by a 4
      week wash-out period. Dietary intervention will be based on iso-energetic substitution of
      sucrose for starch in a weight-maintaining diet. The two experimental conditions are: high
      sucrose diet at 25% of total energy intake (this is approximately the 95th percentile for UK
      intake of non-milk extrinsic sugars (NMES)); and low sucrose diet at 10% of total energy
      intake. Otherwise the macronutrient balance in both conditions will be based on UK average
      habitual intake.

      POPULATION 10 healthy males aged between 20 and 40 years, with a BMI between 20-25kg/m2, with
      normal liver fat levels (<5%) and fasting plasma glucose and no evidence of insulin
      resistance will be recruited. No pre-existing morbidity including cardiac, hepatic or renal
      disease, history of diabetes, hypertension or hyperlipidemia. Usual physical activity of
      subjects to range from sedentary to a maximum of meeting the UK minimum activity
      recommendations (30 min moderate exercise 5 d/week). Habitual alcohol intake of less than 2
      units per day.

      TREATMENT Pre-intervention: Participants will be asked to record habitual dietary intake by
      completion of a 7-day food diary and be asked to wear an accelerometer armband to assess
      physical activity before each intervention week. Resting energy expenditure will also be
      assessed by indirect calorimetry.

      7 day dietary interventions: Participants will be resident at the clinical research facility
      at Hammersmith Hospital during each intervention week for 5 out of the 7 days and all food
      will be provided at the facility. At the weekends, participants will have to leave the unit
      but food will be provided for those two days so that the diet can be continued at home.

      At the start and end of each 7 day intervention: Weight, height and waist circumference will
      be taken; percentage liver fat and total and regional body composition will be measured by
      MRI. Fasting and post prandial plasma glucose, insulin and lipids will be measured and blood
      pressure.
    

Intervention name(s): Sucrose
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Sucrose in diet
Study to Determine Whether Ramelteon Helps People With REM Sleep Behavior Disorder
Condition: REM Sleep Behavior Disorder
MeSH terms: REM Sleep Behavior Disorder; Mental Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether the use of the drug ramelteon decreases the
      symptoms of REM Sleep Behavior Disorder.
    

Detailed description: 
      This is a randomized double blind placebo controlled study to determine whether the use of
      ramelteon decreases symptoms of RBD. Outcome measures are determined by change in RBD
      polysomnographic score and assessment scores on the RBD symptom questionnaire and sleep
      diary.
    

Intervention name(s): ramelteon; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 8 mg nightly for 30 nights; placebo control i pill nightly for 30 nights
Other intervention name(s): rozerem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Instrumental Soft Tissue Mobilization in Patients With Chronic Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      In this study, it was planned to investigate the effectiveness of instrument-assisted soft
      tissue mobilisation (IASTM) in patients with chronic neck pain. Forty eight individuals with
      chronic neck pain between the ages of 18-70 were included in the study. Individuals were
      randomly divided into two groups as Combined Therapy (CT) (n = 24) and Exercise Therapy (ET)
      (n = 24) groups. All exercises were applied to the participants for 4 weeks, 3 times a week,
      by an experienced physiotherapist for 5 years under supervision. ET which included stretching
      and strengthening exercises involving the neck, shoulder and around the scapula muscles
      applied according to the tolerance of the individuals and targeted to be most beneficial in
      daily life activities.

      CT in addition to the ET applied 3 times a week for 4 weeks, the participants received a
      total of 8 sessions of IASTM on the days they came to the treatment twice a week, before the
      ET. As soon as the participants came to the session, IASTM was applied first. Following the
      IASTM application, ET was applied in the same protocol and under the same therapist supervise
      with the ET group.

      Before and after treatment, deep neck flexor muscle endurance (DNFME), pain severity with
      Visual Analogue Scale (VAS) and Brief Pain Inventory (BPI), functional status with Neck
      Disability Index (NDI), quality of life with Nottingham Health Profile (NHP) treatment and
      treatment satisfaction was evaluated.
    


Intervention name(s): instrumented- assisted soft tissue mobilization (IASTM)
Intervention type(s): Other
Intervention description(s): IASTM is a new, non-invasive, conservative therapeutic approach. Instead of the therapist's hands and fingers in treatment, these devices are used to provide contact mobilization power. AYDM intervention, such as friction, rubbing massage treatments, requires the therapist to apply a significant amount of pressure. The main purpose of IASTM is to eliminate scar tissue and to restore the normal function of the tissue following soft tissue regeneration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Lipid Efficacy/Tolerability Study (0524A-020)
Condition: Primary Hypercholesterolaemia; Mixed Hyperlipidaemia
MeSH terms: Hyperlipidemia, Familial Combined; Hyperlipoproteinemia Type V; Lipidoses; Hypercholesterolemia; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 3

Summary: 
      A 28-week clinical trial in patients with primary hypercholesterolemia or mixed
      hyperlipidemia to study the effects of MK0524A on lipids and tolerability. There will be 9
      scheduled clinic visits, and 3 treatment groups. A patient can be randomly assigned to 1 of
      the 3 treatment groups.
    


Intervention name(s): niacin (+) laropiprant; ER-niacin
Intervention type(s): Drug; Drug
Intervention description(s): Duration of Treatment - 24 weeks; Duration of Treatment - 24 weeks
Other intervention name(s): MK0524A
Intervention MeSH terms: Niacin; Niacinamide; Nicotinic Acids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of Painful Compared to Painless Manual Therapy on Pain Processing in University Students With Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of provoking pain with manual therapy on
      pain processing in university students with recurrent or chronic neck pain.
    

Detailed description: 
      The mechanical stimulus produced in manual therapy (MT) techniques elicits neurophysiological
      responses within the peripheral and central nervous system responsible for pain inhibition.
      Almost all types of MT elicit a neurophysiological response that is associated with the
      descending pain modulation circuit. But it has not been demonstrated whether this inhibition
      occurs through a conditioned pain modulation mechanism generated by the pain that manual
      therapy techniques may elicit in the patient.
    

Intervention name(s): Manual Therapy
Intervention type(s): Other
Intervention description(s): Postero-anterior mobilizations: the physiotherapist will place his thumbs on the posterior surface of the spinous process of the vertebra previously assessed as the most painful to mobilise. The oscillations will be performed at the frequency of 1 oscillation per second and will be performed 3 series of 3 minutes, with a 1 minute rest interval.
Pressure: The point of greatest pain shall be treated by maintained pressure in each of the following areas: right upper trapezius, left upper trapezius, right paravertebral musculature and left paravertebral musculature. Pressure shall be applied to each of the points for 1 minute.
Massage: Pressure is applied to the muscles by sliding along the muscle belly. This will be done slowly to control the pain that is being provoked. 3 minutes will be carried out on each upper trapezius, sliding from the acromion to the occipital and another 3 minutes on the paravertebral musculature on each side, sliding from T1 to the occipital.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Manual Therapy; Physiotherapy; Physical Therapy; Conditioned Pain Modulation; Neck Pain
Cognitive and Psychosocial Outcome After Mild Traumatic Brain Injury
Condition: Mild Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Wounds and Injuries
Study type: Observational [Patient Registry]

Summary: 
      Patients with traumatic brain injury are likely to present with cognitive, psychological,
      emotional and behavioral problems during different periods, all of which affect patients'
      life quality seriously. The aim of this study was to assess cognitive and psychosocial
      outcome in patients with mild traumatic brain injury, and to determine the risk factors
      associated with cognitive and psychological outcome. Mini-mental state examination (MMSE),
      activities of daily living scale (ADL), the Hospital Anxiety Depression Scale (HADS) and
      mental health symptom checklist (SCL-90) were used to assess the cognitive performance and
      psychological outcomes in 360 patients with mild traumatic brain injury. Chi-square, Fisher's
      exact tests and Logistic regression analysis were used to analyze the risk factors.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        360 patients with mild traumatic brain injury were enrolled in this study. Their age ranged
        from 18 to 60 years, with mean age of 54.3 years. Types of trauma included scalp hematoma,
        scalp laceration, cerebral contusion, subarachnoid hemorrhage, cerebral concussion,
        epidural hematoma, subdural hematoma and skull fracture. Mechanisms of injury contained
        traffic accident, fall, industrial accident, etc. Occupation of patients included cadres,
        workers, farmers, individual, unemployed. Education: college or above, middle school,
        primary school.
      
Keywords: Mild traumatic brain injury; Cognitive outcome; Psychological outcome
A Study to Assess AC220 Given in Combination With Induction and Consolidation Therapy in Newly Diagnosed Acute Myeloid Leukemia (AML)
Condition: Leukemia, Myeloid, Acute
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to define the maximum tolerated dose (MTD) of AC220 when
      combined with induction and consolidation therapy and as maintenance therapy following
      induction and consolidation.
    

Detailed description: 
      Subjects will receive escalating doses of AC220 plus standard 7+3 cytarabine and daunorubicin
      remission induction therapy. Subjects may receive up to 2 cycles of induction therapy.
      Subjects who have a complete response (including complete remission (CR) with incomplete
      hematologic recovery) are eligible to receive up to 3 consolidation cycles. In consolidation
      subjects will receive AC220 plus high dose cytarabine. Subjects achieving a composite
      Complete Remission (CRc) will be eligible to receive AC220 alone for up to 12 additional 28
      day cycles.

      Subjects will be enrolled into successive gender balanced cohorts of 6 subjects (at least 3
      must be females) to determine the maximum tolerated dose (MTD). Dose escalation decision will
      be made based on dose limiting toxicities (DLTs) that occur during the first remission
      induction cycle. Seven and 14 day schedules will be evaluated.

      After the MTD and schedule is established, the study will open to enroll between 14 to 34
      subjects. Subjects will receive AC220 during induction and consolidation at the MTD and
      schedule established. Stopping rules will be used to evaluate safety at the current dose. If
      testing at a dose level must be stopped, then a lower dose may be tested. MTD will also be
      established for the maintenance therapy.
    

Intervention name(s): AC220; daunorubicin; cytarabine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral Liquid; Intravenous Infusion; Intravenous Infusion
Other intervention name(s): quizartinib; ASP2689; Cerubidine; daunorubicin hydrochloride; Ara-C; Cytarabine Hydrochloride; Cytosar; Cytosine; Arabinoside
Intervention MeSH terms: Cytarabine; Daunorubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AC220; Acute Myeloid Leukemia (AML); De Novo Acute Myeloid Leukemia (AML); Newly diagnosed Acute Myeloid Leukemia (AML); FMS-like tyrosine kinase (FLT3); FMS-like tyrosine kinase (FLT3) Inhibitor; Kinase; Kinase Inhibitor; Pharmacokinetics; ASP2689; quizartinib
Placebo-Controlled Study of Atomoxetine Hydrochloride in the Treatment of Adults With ADHD and Comorbid Social Anxiety Disorder
Condition: Attention Deficit Hyperactivity Disorder; Comorbid Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Attention Deficit Disorder with Hyperactivity; Phobia, Social
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate the effect of atomoxetine hydrochloride in treating adults who have attention
      deficit hyperactivity disorder with comorbid social anxiety disorder
    


Intervention name(s): Atomoxetine hydrochloride; placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Surgery to remove axillary lymph nodes may be an effective treatment for women
      with breast cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of therapy with or without
      axillary lymph node dissection following quadrantectomy in treating older women with stage I
      breast cancer that is estrogen receptor positive.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the efficacy of quadrantectomy with or without axillary lymph node dissection,
           followed by tamoxifen in terms of local and distant relapse rates and overall survival
           of patients with stage I, invasive breast cancer.

        -  Determine the relationship between biological variables, such as hormone receptor
           status, cell proliferation, and DNA ploidy, and the clinical outcome of the disease in
           these patients.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified by center. Patients
      are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients undergo quadrantectomy with dissection of level I and II axillary lymph
           nodes.

        -  Arm II: Patients undergo quadrantectomy without axillary lymph node dissection. Patients
           on both arms receive tamoxifen daily for 5 years.

      Patients are followed every 4 months for 2 years, every 6 months for 2 years, and then
      annually thereafter.

      PROJECTED ACCRUAL: A total of 642 patients will be accrued for this study within 3 years.
    

Intervention name(s): tamoxifen citrate; conventional surgery
Intervention type(s): Drug; Procedure
Intervention MeSH terms: Tamoxifen
Allocation: Randomized
Primary purpose: Treatment
Keywords: stage I breast cancer
Treatments for Improving Mood in Depressed Teens-3
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      Phase 3 is a randomized clinical trial of yoga vs group Cognitive Behavioral Therapy (CBT)
      for adolescents with depression.
    

Detailed description: 
      In Phase 3, Study A, the investigators will conduct a pilot Randomized Control Trial (RCT) of
      12 weeks of hatha yoga vs. 12 weeks of group CBT.

      Participants will be adolescents with depression. Parents will also be invited to participate
      in assessments regarding their child.

      Study B, which will run concurrent to Phase 3, will be for participants who did not meet the
      depression inclusion criteria or had recent changes in therapy or medications that make them
      ineligible for Phase 3. Their data will not be analyzed. They are recruited only for group
      participation.

      Participants will be randomized to Phase 3 groups of 12 weeks of hatha yoga or group CBT.
      Parents will also be invited to participate in assessments regarding their child.

      * Due to social distancing requirements related to COVID-19, all interventions have been
      delivered remotely via video-based platforms as of late March 2020.
    

Intervention name(s): Yoga; Group CBT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Hatha yoga for depressed adolescents; Group cognitive behavioral therapy for depressed adolescents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment