bioihbjkbjnl/mcl2 huggingface dataset:
Study of Lenvatinib (E7080) in Participants With Advanced Hepatocellular Carcinoma (HCC)
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine maximum tolerated dose (MTD), efficacy, safety and
      tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor effect of E7080 when is
      administered continually once daily in participants with advanced hepatocellular carcinoma.
    


Intervention name(s): Lenvatinib
Intervention type(s): Drug
Intervention description(s): In the Dose-Escalation Component of the study, lenvatinib will be administered as continuous once-daily oral dosing. Dose-escalation will occur based on safety information obtained during Cycle 1. The recommended dose for the Expansion Component of the study will use the MTD in Cycle 1.
Other intervention name(s): E7080
Intervention MeSH terms: Lenvatinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Carcinoma; Hepatocellular
Pharmacokinetic Study of Aztreonam-Avibactam in Severe Renal Impairment
Condition: Renal Insufficiency
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 study is being conducted to evaluate the effect of severe renal impairment on
      the PK, safety and tolerability of Aztreonam-Avibactam. Results from this study along with
      previous renal impairment data from each of the Aztreonam-Avibactam components will be used
      to confirm the proposed dosing adjustment in severe renal impairment which was based on
      modelling/simulation.
    


Intervention name(s): Aztreonam-Avibactam; Aztreonam-Avibactam
Intervention type(s): Drug; Drug
Intervention description(s): 500/167 mg ATM/AVI loading infusion, followed by 1500/500 mg ATM/AVI extended loading infusion, then 1500/500 mg ATM/AVI maintenance dose infusion every 6 hours; 675/225 mg ATM/AVI loading infusion, followed by 675/225 mg ATM/AVI extended loading infusion, then 675/225 mg ATM/AVI maintenance dose infusion every 8 hours
Intervention MeSH terms: Aztreonam; Avibactam
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Infection
Systematically Assessing Effects of Colored Light on Humans With a Multi-modal Approach (Substudy 3 of 7)
Condition: Exposure to Man-made Visible Light
Study type: Interventional

Summary: 
      NOTE: This is the third of in total 7 sub-studies related to the Ethics Committee of the
      Canton of Bern Ref. No. KEK-BE 2016-00674. This sub-study includes 50 participants and 6
      arms, in total 350 participants will be assessed in all 7 sub-studies.

      General study information: This is a randomized, cross-over, quantitative study, which
      investigates physiological variables, mood, and affect of healthy participants in response to
      colored light exposure. The Participants take part in 5-8 arms and are exposed to colored
      light only, or are additionally asked to solve cognitive tasks during the colored light
      exposure. Primary aim is to measure the change in several physiological variables, mood, and
      affect during colored light exposure of 15 or 45 minutes. The risk for the participants is
      negligible and comparable to the risk during daily life.
    


Intervention name(s): Visible light exposure
Intervention type(s): Other
Intervention description(s): Subjects will be exposed to visible colored light for 15 minutes. The visible light will be generated by red-green-blue light emitting diodes light cans.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: cerebral oxygen metabolism; functional near-infrared spectroscopy; partial pressure of carbon dioxide; heart rate variability; blood pressure; affect; mood; respiration; systematic randomized cross-over study; systemic physiology; electro-dermal activity; pulse-respiratory quotient
Piloting Home-based Movement-to-Music Among Adolescents With Cerebral Palsy: A Randomized Controlled Trial
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      This study pilots the efficacy of a home-based movement-to-music program for increasing
      physical activity participation among adolescents with cerebral palsy. Half of the
      participants will receive the movement-to-music program immediately, which will include 4
      weeks of exercise videos and periodic behavioral coaching calls. The other half of
      participants will wait 4 weeks before receiving the M2M program.
    

Detailed description: 
      The movement-to-music program has been tested among adults with physical disabilities and is
      currently being used in ongoing scale-up clinical trials. Current evidence suggests that the
      program can increase aspects of physical function among adults. The present study aims to
      test whether the same program can be used among adolescents with cerebral palsy. Study
      findings will be used to examine whether the videos require modifications prior to being
      implemented in a future scale-up trial for adolescents people with cerebral palsy.
    

Intervention name(s): Movement-to-music
Intervention type(s): Behavioral
Intervention description(s): Movement-to-music is a physical activity program that was developed onsite at a state-of-the-art adapted fitness facility. The program includes movements that are coupled with music to enhance muscular strength, cardiorespiratory capacity, flexibility, and balance. For this study, the program will be packaged into playlists of exercise videos that will be given to participants. Participants will be instructed to complete the prescribed videos 3 times per week. Participants will also be asked to attend 4 behavioral coaching calls with a telecoach. The goals of the behavioral coaching calls will be to address issues with the technology components of the program and promote physical activity participation within the community and adherence to the movement-to-music videos.
Other intervention name(s): M2M
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: exercise; physical activity; telehealth
Single Rising Dose Study of BI 690517 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate safety, tolerability, pharmacokinetics and pharmacodynamics following single
      rising doses of BI 690517
    


Intervention name(s): BI 690517
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Evaluation of 3 Contact Lens Materials With 3 Solution Types
Condition: Visual Acuity, Slit Lamp Biomicroscopy (Corneal Staining Assessment)
Study type: Interventional

Summary: 
      This is a multi-site, randomized, double-masked, contralateral, 2 treatment x 2 period
      crossover, dispensing, five-visit study to gain clinical insights of the study lenses and
      solutions.
    


Intervention name(s): Opti-Free : RevitaLens / Clear Care : RevitaLens; Opti-Free : RevitaLens / RevitaLens : Clear Care; Clear Care : RevitaLens/ Opti-Free : RevitaLens; Clear Care : RevitaLens / RevitaLens : Opti-Free; RevitaLens : Clear Care/ Opti-Free : RevitaLens; RevitaLens : Clear Care / RevitaLens : Opti-Free; RevitaLens : Opti-Free / Clear Care : RevitaLens; RevitaLens : Opit-Free / RevitaLens : Clear Care
Intervention type(s): Device; Device; Device; Device; Device; Device; Device; Device
Intervention description(s): Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.; Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.; Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.; Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.; Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.; Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.; Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.; Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
Other intervention name(s): Right eye : left eye / right eye : left eye; Right eye : left eye / right eye : left eye; Right eye : left eye / right eye : left eye; Right eye : left eye / right eye : left eye; Right eye : left eye / right eye : left eye; Right eye : left eye / right eye : left eye; Right eye : left eye / right eye : left eye; Right eye : left eye / right eye : left eye
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of Konjac Glucomannan Noodle Intervention in Subjects With Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      Metabolic syndrome (MS) is a complex disease with a cluster of risk factors and clinical
      features, which includes central or abdominal obesity, atherogenic dyslipidemia, impaired
      glucose regulation, hyperinsulinemia, high blood pressure, and concomitance of
      pro-inflammatory cytokine and insulin resistance. Glucomannan (GM) is a water-soluble dietary
      fiber derived from the root of Amorphophallus konjac that can improve blood sugar, blood fat
      concentration, and weight management, and has other health benefits.The purposes of this
      study are going to investigate the effects of KGM noodle (KGN) as stable food to MS and
      diabetic patients.
    

Detailed description: 
      The KGN diet was composed of well-cooked noodle with 2 g of KGM in a dosage of 200 g/piece
      twice daily to substitute the daily carbohydrate for 4 weeks, with a 2-week washout period
      between alternative diets. All 33 subjects received two servings of either GMNs or PNs (400
      g) per day, which replaced the main carbohydrate in two daily meals for 4 weeks. After a
      2-week washout period, the subjects received the other type of noodle for 4 weeks. The body
      weight, BMI, waist circumference, fasting blood glucose and lipid profile, as well as serum
      vitamin A, E, β-carotene and high sensitivity C-reactive protein (hs-CPR) were measured by
      HPCL.
    

Intervention name(s): Glucomannan noodle; Placebo noodle
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The participants received two servings (400 g) of GMN every day to replace their daily carbohydrate intake for 4 weeks.; In the placebo noodle diet, the participants received the same amount of noodles without glucomannan for 4 weeks.
Intervention MeSH terms: (1-6)-alpha-glucomannan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Study of the Collaborative Life Skills Program
Condition: Attention Deficit Hyperactivity Disorder Symptoms
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      This study tests the effectiveness of a newly developed integrated school-home behavioral
      intervention for behaviors related to Attention Deficit Hyperactivity Disorder (ADHD). The
      intervention is implemented by school-based mental health professionals within school
      settings.
    


Intervention name(s): Collaborative Life Skills Intervention (CLS); Business As Usual
Intervention type(s): Behavioral; Other
Intervention description(s): CLS is a 12-week program and includes school, parent, and student components which are integrated via joint teacher, parent, and student meetings and use of integrated behavioral programs in the classroom, on the playground, and at home.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Attention Deficit Hyperactivity Disorder; Psychosocial Intervention; Behavioral Intervention; School-home collaborative intervention
Validating Reward-related Biomarkers (RTOC)
Condition: Schizophrenia; Depression; Motivation; Anhedonia, Physical; Anhedonia, Social; Negative Symptoms With Primary Psychotic Disorder
MeSH terms: Anhedonia; Schizophrenia; Psychotic Disorders
Study type: Observational

Summary: 
      Deficits or abnormalities in reward processing are present in a number of psychiatric
      disorders. The overarching objective of the study is to conduct initial validation work
      towards optimising three experimental tasks - which have previously been shown to be
      sensitive to reward processing deficits - for future use in clinical trials.

      This initial validation work has the primary objective to uncover group differences in task
      outcome measures between healthy control participants, participants with Major Depressive
      Disorder (MDD) and participants with schizophrenia (SZ) using statistical analyses. This may
      provide some indications for the use of these tasks as clinically-relevant biomarkers.

      Primary aims include:

      (i) comparing the investigator's endpoint means and distributions to those in previously
      published data; (ii) replication of previously-reported differences between MDD/SZ vs.
      healthy control participants, and, (iii) exploring the relationship between task endpoints
      and subjective participant- and clinician-rated report of reward-related constructs (e.g.
      anhedonia, negative symptoms).
    


Intervention name(s): Self-rating Questionnaires; Measures of Reward processing/reinforcement learning; Additional Schizophrenia-specific Questionnaires and Interviews
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Snaith-Hamilton Pleasure Scale (SHAPS; Snaith et al. 1995)
Quick Inventory of Depressive Symptomatology (QIDS; 16 items)
Behavioral avoidance/inhibition Scales (BIS/BAS); Grip Strength Effort Task (Reddy et al. 2015; in combination with EEG)
Doors (Gambling) task (Foti and Hajcak 2009; in combination with EEG)
Reinforcement Learning/Working Memory task (Collins et al. 2017; no EEG); Positive and Negative Syndrome Scale (PANSS: Kay et al. 1987)
Brief Negative Symptom Scale (BNSS; Kirkpatrick et al. 2011)
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        A sample of 37 completed individuals with MDD, 37 completed individuals with SZ, and a
        maximum of 80 healthy volunteers (without a neurological or psychiatric disorder) who will
        not differ on age or gender.
Is It Possible to Predict Pre Term Labor by Measuring Cervical Length in the Non-pregnant Uterus?
Condition: Preterm Birth
MeSH terms: Premature Birth; Obstetric Labor, Premature
Study type: Observational

Summary: 
      Working hypothesis and aims:

      To investigate the association between cervical length in non-pregnant women, and the risk of
      premature birth.

      The participants will be recruited from the HaEmek Medical Center delivery room registration.
      Women delivered between 24-37 pregnancy weeks will be allocated to the study group. The
      investigators will invite them 3 month or more after delivery to ultrasound examination of
      the cervical length. The participants in the control group will be the women whom term
      delivery follows by chronological manner to those in study group. Data of the cervucal length
      will be collected at the time of the examination.
    

Detailed description: 
      Women will be invited to undergo an examination in Ultrasound Unit of Department of
      Obstetrics and Gynecology, HaEmek Medical Center.

      Ultrasound examination will be performed using the Voluson E8 device, General Electric.

      The cervical length,between the external and internal orifice will be measured using
      conventional technologies available including: Doppler, three dimensional and two dimensional
      ultrasound.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HaEmek Medical Center delivery room.
Validation of the Turkish Swallowing Disturbance Questionnaire
Condition: Parkinson Disease; Dysphagia
MeSH terms: Deglutition Disorders; Parkinson Disease
Study type: Observational

Summary: 
      Purpose of the study is the validity and reliability of the Turkish version of the Swallowing
      Disturbance Questionnaire (SDQ-T), so that it would be used as an assessment tool for Turkish
      Parkinson Disease's (PD) patients. Despite being translated and validated in many languages,
      there is no validated Turkish version of SDQ to measure the severity of dysphagia in PD.
    

Detailed description: 
      Parkinson's disease (PD) patients who suffered from dysphagia have reported significantly
      reduced quality of life. The swallow function is a multidirectional process that depends on
      complex neuro-muscular network. The function can be evaluated using instrumental, such as
      fibreoptic endoscopic evaluation of swallowing (FEES), videofluoroscopy, or well structured
      questionnaires. There are many questionnaire and scales for assessment of dysphagia in PD but
      very few have been validated. The study will assess the construct validity and reliability of
      the Turkish version of Swallowing Disturbance Questionnaire. The investigators developed the
      Turkish version of this questionnaire (SDQ-T), according to the cross-cultural adaptation
      guidelines. Two translators translated the SDQ into Turkish and a native English language
      speaker reverse-translated it into English. The back translation was sent to the original
      author for proofreading. The SDQ questionnaire consisted of 15 basic questions related with
      dysphagia symptoms in PD patients.
    

Intervention name(s): Turkish Version of Swallowing Disturbance Questionnaire
Intervention type(s): Other
Intervention description(s): The Turkish Version of Swallowing Disturbance Questionnaire consists of 15 questions related with dysphagia.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Parkinson's disease patients
      
Keywords: Parkinson's disease; dysphagia; questionnaire; swallowing; validation
Effectiveness of Different Hypopressive Exercises in Pelvic Floor Dysfunction
Condition: Pelvic Floor Disorders
MeSH terms: Pelvic Floor Disorders
Study type: Interventional

Summary: 
      The purpose of the study is to compare the efficacy of different modalities of hypopressive
      exercises and biofeedback with ultrasound in women with pelvic floor dysfunctions,
      considering the efficacy of the treatment as improving the specific quality of life related
      to pelvic floor dysfunctions and improvement of the muscular properties of the pelvic floor
      muscles.
    

Detailed description: 
      Female 18-65 years old

      Inclusion Criteria:

      Women diagnosed with pelvic floor dysfunction by their doctor. With minimum strength of the
      pelvic floor muscles of 3 according to Modified Oxford Score

      Exclusion Criteria:

      Women who are pregnant or women who have had a vaginal or caesarean birth in the past six
      months.

      Women whose PFD is severe and the first indication is surgical (POP-Q grade III-IV
      prolapses).

      Women with only urinary incontinence or fecal urgency. Women with pain in the pelvic-perineal
      region of 3 cm in the visual analog scale, where a score of 0 cm means no pain, and a score
      of 10cm, the maximum pain that the participant can imagine.

      Women who have received pelvic floor physiotherapy treatment in the last 12 months.

      Women who are unable to voluntarily contract the pelvic floor muscles, quantified by the
      Modified Oxford Score by a score less than or equal to 2.

      Women with any pathology that may affect the treatment (neurological, gynecological or
      urological), or with recurrent urinary infection or hematuria.

      Women with cognitive limitations to understand the information, answer the questionnaires,
      consent and / or participate in the study.
    

Intervention name(s): Hypopressive exercises; Hypopressive maneuver; Hypopressive exercises plus pelvic floor muscle contraction; Hypopressive maneuver plus pelvic floor muscle contraction
Intervention type(s): Other; Other; Other; Other
Intervention description(s): See information included in arm/group descriptions.; See information included in arm/group descriptions.; See information included in arm/group descriptions.; See information included in arm/group descriptions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypopressive exercises; Pelvic floor muscle trianing; Ultrasound