bioihbjkbjnl/mcl2 huggingface dataset:
Binges and Neural Variability
Condition: Binge-Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Observational

Summary: 
      People who suffer from binge eating disorder experience recurrent episodes of binge
      eating.During these episodes, they consume an unusually large amount of food in a short
      amount of time and experience loss of control over eating. However, why such binge eating
      episodes occur is still largely unknown. This makes it difficult to develop targeted
      treatments. In this project, the experimenters are investigating the brain mechanisms that
      give rise to the disorder. They hypothesize that the binge eating episodes are due to an
      increased variability in reward processing, which they will assess repeatedly over days. They
      will test this hypothesis using mathematical models based on behavioural and MRI measurements
      that are related to the processing of rewards.
    


Intervention name(s): fMRI
Intervention type(s): Diagnostic Test
Intervention description(s): (Imaging while) performing reward related tasks.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The control group will consist of residents of the general area around Tübingen, Germany.

        BED patients will be recruited mainly from the outpatient clinic of the Department of
        Clinical Psychology of Tübingen, Germany.
      
Biospecimen description: 
      serum
    
Keywords: reward sensitivity; neuroimaging; variability; ecological momentary assessment (EMA)
Biochemical Brain Changes Correlated With The Antidepressant Effect Of Thyroid Hormones
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      We propose to investigate structural and biochemical brain abnormalities in depressed
      subjects, and the relationship between the presence of such abnormalities and treatment
      outcome. We will recruit N=20 subjects with major depression disorder and N=20 matched normal
      controls. The depressed subjects would have previously not responded to an adequate trial
      with a selective serotonin reuptake inhibitor (SSRI). These depressed subjects will be
      treated for 4 weeks with the same SSRI antidepressant and with adjuvant triiodothyronine
      (T3). Structural magnetic resonance images (MRI) and then Phosphorus-31 magnetic resonance
      spectroscopic imaging (31P-MRSI) data will be obtained two times for each patient (at the
      beginning and at the end of the study) and one time for the normal controls. We will measure
      for each depressed subject the number of white matter hyperintensities (WMH); we will also
      measure the degree of change from baseline in several compounds characteristic for the
      cellular high-energy phosphate metabolism: the phosphocreatine/inorganic phosphate ratio and
      the beta-nucleoside triphosphate. We will compare the severity of WMH and the high-energy
      phosphate metabolism in two groups of depressed subjects (those responding and those not
      responding to thyroid hormone augmentation) and the normal controls.

      We hypothesize that:

        1. All depressed subjects, when compared with normal controls, will present lower baseline
           levels of compounds characteristic for the high-energy phosphate metabolism.

        2. Depressed subjects responding to T3 augmentation, when compared with subjects not
           responding to T3 augmentation, will present a larger increase of the high-energy
           phosphate metabolism.
    


Intervention name(s): Cytomel (liothyronine)
Intervention type(s): Drug
Intervention description(s): Cytomel (liothyronine) 25-50 mcg/day for 4 weeks
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CC-99677 in Healthy Adult Japanese Participants.
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK),
      pharmacodynamics (PD) and pharmacogenomics (PG) of multiple doses of CC-99677 in healthy
      Japanese adult participants. This study will be placebo-controlled to appropriately
      characterize the safety and tolerability of CC-99677.
    


Intervention name(s): CC-99677; Placebo
Intervention type(s): Drug; Other
Intervention description(s): CC-99677; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy Volunteers; CC-99677; Phase 1; Japanese
A Study to Test How Effective and Safe Different Doses of BI 655130 Are in Patients With a Moderate to Severe Form of the Skin Disease Palmoplantar Pustulosis
Condition: Palmoplantar Pustulosis (PPP)
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to provide dose-ranging data for 4 dose regimens of BI 655130
      compared to placebo on the primary endpoint of percentage change from baseline in PPP ASI at
      Week 16. The target dose(s) will be estimated from the model by incorporating information on
      the minimum clinically relevant effect and accounting for safety.

      Supportive dose-ranging assessments will also be done on pre-specified secondary endpoints.
    


Intervention name(s): Spesolimab; Placebo; Spesolimab; Spesolimab; Spesolimab; Spesolimab
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subcutaneous injections of Spesolimab starting at week 16, for a total treatment time until week 52.; Subcutaneous injections of placebo matching Spesolimab from week 0 to 16.; Subcutaneous injections of Spesolimab in a low dose scheme for a total treatment time of 52 weeks.; Subcutaneous injections of Spesolimab in a medium-low dose scheme for a total treatment time of 52 weeks.; Subcutaneous injections of Spesolimab in a medium-high dose scheme for a total treatment time of 52 weeks.; Subcutaneous injections of Spesolimab in a high dose scheme for a total treatment time of 52 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Preliminary Study 1 to Test the Effects of Ambulatory Voice Biofeedback
Condition: Vocal Fold Nodules
Study type: Interventional

Summary: 
      This first study will enroll 3 groups of patients with vocal fold nodules that will receive
      different schedules of ambulatory voice biofeedback (100% frequency feedback, 25% frequency
      feedback, summary feedback) to avoid their upper 15th percentile of vocal loudness.
    

Detailed description: 
      We will conduct this study (based on principles of motor learning) using novel
      smartphone-based ambulatory voice biofeedback systems aimed at improving the carryover of
      newly established vocal behaviors into daily life. This first study will determine which of
      three types of ambulatory feedback results in better learning/retention (100% frequency, 25%
      frequency, or delayed summary feedback every 2 minutes of voicing) of a new vocal behavior
      (reduced vocal intensity) in three groups of 15 patients with vocal fold nodules. Hypothesis:
      Patients receiving lower frequency or summary feedback will produce lower initial performance
      but higher short- and long-term retention than patients receiving feedback 100% of the time.
    

Intervention name(s): Ambulatory voice biofeedback
Intervention type(s): Behavioral
Intervention description(s): Subjects will be provided cues regarding their vocal behavior in daily life. The cues will either be: 100% feedback = a vibrotactile cue on a smartwatch every time the patient voices incorrectly... 25% feedback = a vibrotactile cue on a smartwatch every 4th time the patient voices incorrectly... Summary feedback = the patient's overall compliance (percentage of voiced time within desired limits) will be presented via a smartwatch every 2 minutes of voicing.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ambulatory; Biofeedback; Voice
Selection Criteria in Endovascular Thrombectomy and Thrombolytic Therapy (SECRET) Study: Development of Patient Selection Criteria Using CT Images and Accompanying Diseases for Efficient Intravenous Thrombolytic and Intra-arterial Recanalization Therapy in Acute Ischemic Stroke
Condition: Ischemic Stroke
MeSH terms: Ischemic Stroke; Ischemia
Study type: Observational [Patient Registry]

Summary: 
      Use of intravenous (IV) thrombolysis and intra-arterial (IA) recanalization treatment has
      been rapidly increasing, However, despite of the treatment, recanalization rates are 22.6 -
      70% and only 30-50% of patients show meaningful clinical improvements. Mechanisms of futile
      recanalization may include 1) large ischemic core, 2) poor collateral, and 3) presence of
      comorbidity. In this regards, developing selection criteria using acute stroke imaging and
      comorbidity is warranted.

      Investigators will recruit the consecutive acute stroke patients who received IV thrombolysis
      and/or IA recanalization treatment. This study will perform with prospective design to
      develop CT-based clot, core and collateral scores and a comorbidity index for selecting
      stroke patients who are at high risks by the treatment. Investigators will firstly establish
      the CT-based scores and comorbidity index using a pre-existing cohort database. Using these
      CT-based and comorbidity index, Investigators will validate them in a multi-center
      prospectively cohort. In addition, Investigators will assess the cost-effectiveness of
      selecting patients based on the comorbidity index.
    


Intervention name(s): Brain CT imaging
Intervention type(s): Other
Intervention description(s): Investigators will analyzed the CT image that was performed in patients with hyperacute stroke. The CT protocol includes CT thrombus, collateral, core images. Investigators also obtain detailed history and laboratory and imaging result for comorbidity. The comorbidity index protocol is based on the Charlson comorbidity index.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Acute ischemic stroke patients who received intravenous (IV) thrombolysis and/or
        intra-arterial (IA) recanalization treatment
Vitamin D, Cardiovascular Disease, and African Americans
Condition: Vitamin D Deficiency; Type 2 Diabetes Mellitus; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Diabetes Mellitus, Type 2; Vitamin D Deficiency
Study type: Interventional

Summary: 
      African-Americans have higher rates of cardiovascular disease morbidity and mortality, as
      well as vitamin D deficiency. Multiple observational studies have demonstrated an increased
      risk of vitamin D deficiency in African Americans with type 2 diabetes and correlation
      between cardiovascular disease and vitamin D levels; however, there is a lack of
      interventional trials exploring this connection. The objective of this proposal is to address
      the hypothesis that treatment of vitamin D deficiency in African Americans with type 2
      diabetes will improve subclinical markers of cardiovascular disease.
    

Detailed description: 
      This study will be a double blinded, randomized controlled trial of vitamin D3
      supplementation, 4,000 international units per day versus 600 international units per day,
      for one year to determine the effects on markers of subclinical cardiovascular disease in
      African Americans with type 2 diabetes and vitamin D deficiency. Outcome assessment will
      focus on changes in carotid intima-medial thickness (CIMT - ultrasound of the thickness of
      blood vessels in the neck), as well as markers of systemic inflammation.
    

Intervention name(s): Vitamin D3; Vitamin D3; Calcium carbonate
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Multivitamin containing cholecalciferol 4000 units orally daily; Multivitamin containing cholecalciferol 600 units orally daily; 500 mg orally twice daily
Other intervention name(s): Cholecalciferol; Cholecalciferol
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins; Calcium Carbonate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Drug-Drug Interaction Study to Evaluate the Effect of PF-06865571 on Metformin Pharmacokinetics
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to assess the effect of PF-06865571 administration on the
      pharmacokinetics of metformin in healthy adult subjects.
    


Intervention name(s): Metformin; PF-06865571
Intervention type(s): Drug; Drug
Intervention description(s): Metformin; PF-06865571
Other intervention name(s): Glucophage
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PF-06865571; Metformin; Drug-drug interaction; Pharmacokinetics
The Effect of Postoperative Modified Trendelenburg Position to Decrease Shoulder Pain After Laparoscopic Hysterectomy: A Randomized Controlled Trial
Condition: Post Operative Pain; Shoulder Pain; Gynecologic Disease
MeSH terms: Shoulder Pain; Genital Diseases, Female; Pain, Postoperative
Study type: Interventional

Summary: 
      Laparoscopic surgery is commonly used procedure in diagnostic and treatment including
      Hysterectomy. Post laparoscopic shoulder pain is common side effect mostly occur after
      surgery. Postoperative Trendelenburg position might decrease pain by reducing the mechanical
      pressure of CO2 on the diaphragm. Maintaining the patient in Trendelenburg for 6 hours
      postoperatively will decrease postoperative shoulder pain.
    

Detailed description: 
      After laparoscopic hysterectomy surgery, Patients in intervention group were positioned in a
      Modified Trendelenburg position (20 °) postoperative for 6 hours because of the limitation of
      this study cannot positioned in Trendelenburg position.

      A modified Trendelenburg position is head and trunk of patient were in neutral position while
      hips and lower extrimities were raised at 20 degree.

      In control group were in neutral position. All patients were asked shoulder pain score at
      ward, 6 , 12, 24 hours after postoperative Modified Trendelenburg position for 6 hours
    

Intervention name(s): Postoperative Modified Trendelenburg position
Intervention type(s): Procedure
Intervention description(s): Patients underwent the laparoscopic hysterectomy were positioned in a Modified Trendelenburg position (20 °) postoperative for 6 hours at ward.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Modified Trendelenburg, Shoulder Pain, Laparoscopic hysterectomy
Paroxysmal Positional Vertigo & Repositioning Maneuvers
Condition: Benign Paroxysmal Positional Vertigo
MeSH terms: Vertigo; Benign Paroxysmal Positional Vertigo; Dizziness
Study type: Interventional

Summary: 
      : Benign Paroxysmal Positional Vertigo is a condition related to vestibular system
      accompanied by dizziness, tinnitus and balance problems leading to increased fall risk and
      potential disability. Various treatment options are available including pharmacotherapy and
      vestibular rehabilitation with varied results
    

Detailed description: 
      Objective: The objective of this study was to compare the efficacy of Modified Epley &
      Semont's maneuver with and without Betahistine for BPPV Material & Methods: The study was a
      single blind randomized control trail. Total number of patients were 97 as calculated by
      Epitool calculator. Duration of the study was of one year from 2 January 2021 to 1st January
      2022. Out of a total 97 patients, 90 met the inclusion criteria. These participants were
      randomized by lottery method into two equal groups. Group A (control group) was receiving
      both maneuvers only while group B (experimental group) included participants receiving
      betahistine along with both maneuvers. The impact of dizziness and quality of life was
      measured through EQ-5D-5L questionnaire and dizziness handicap inventory (DHI) in order to
      analyze the effectiveness of treatments. Pre and Post treatment results were compared within
      group by Wilcoxon rank test and for between groups, Mann Whitney U test was performed
    

Intervention name(s): Modified eply & Semont maneuver; betahistine & Modified eply & Semont maneuver
Intervention type(s): Other; Other
Intervention description(s): repositioning maneauvers; antihistamine plus repositioning maneuvers
Other intervention name(s): Modified eply & Semont maneuver
Intervention MeSH terms: Betahistine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 groups , group A contro group and group B experimental group
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: BPPV
SWitching to Abilify Trial (SWAT)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the efficacy, safety and tolerance of an 12 and 26-week aripiprazole
      administration
    

Detailed description: 
      This trial was designed to evaluate the efficacy, safety and tolerance of an 12 and 26-week
      aripiprazole administration to schizophrenic outpatients who maintain stable (no change with
      dosage, usage, route of the most recent antipsychotic drugs) symptoms and discontinued
      previous antipsychotic drugs.

      Aripiprazole (10~30 mg/day) will be orally administered for 12 weeks followed by an extension
      phase for a maximum of an additional 14 weeks (total of 26 weeks).
    

Intervention name(s): Aripiprazole, Solian, Olanzapine, Seroquel, Risperidone
Intervention type(s): Drug
Intervention MeSH terms: Olanzapine; Risperidone; Aripiprazole; Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Aripiprazole
Validating Cardiac MRI Biomarkers and Genotype-Phenotype Correlations for DMD
Condition: Muscular Dystrophy, Duchenne
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional

Summary: 
      This study will collect MRI from healthy volunteer boys and boys with Duchenne Muscular
      Dystrophy (DMD) to help researchers identify and validate cardiac MRI biomarkers to better
      understand the health of the heart and changes in heart health over time in boys with DMD.

      Currently, there is a lack of sufficiently well characterized cardiac MRI biomarkers that can
      serve as endpoints for detecting on-target and/or off-target cardiac effects during clinical
      drug trials for boys with DMD.

      Consequently, the first objective is to identify and characterize several cardiac MRI
      biomarkers for boys with DMD.
    

Detailed description: 
      The second objective is to use their well-characterized cardiac MRI biomarkers and define
      their sensitivity for detecting early cardiac involvement. The final objective is to use
      these validated cardiac MRI biomarkers to better understand the genotype-phenotype
      correlation in boys with DMD, which to date remain tenuous. The investigators propose a pilot
      study to explore cardiac genotype-phenotype correlations in boys with DMD and outlier
      phenotypes using approaches they have pioneered for skeletal muscle.
    

Intervention name(s): Cardiac MRI with contrast; Cardiac MRI without contrast; Blood Test; Heart Rate; Pulmonary Function Test; Genetic Testing; Repeat MRI scan
Intervention type(s): Other; Other; Other; Other; Other; Other; Other
Intervention description(s): Cardiac MRI; Cardiac MRI; Hematocrit, Creatinine, Troponin, BNP; Holter Monitor; Pulmonary Function Test; Genetic Testing; Repeat MRI scan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Creatine Supplementation in Female Collegiate Dancers
Condition: Creatine
Study type: Interventional

Summary: 
      This study will be a 6 week creatine supplementation intervention with performance
      familiarization and pre and post testing. Participants will report to the human performance
      laboratory (HPL) for baseline to read and sign an informed consent explaining the procedures
      and potential risks and benefits of participation. Participants will then complete a physical
      activity readiness questionnaire (PAR-Q) prior to performing any physical tasks. Participants
      will also be asked to complete testing below in the order described. Participants will become
      familiar with the pre/post performance tests, which include isokinetic testing, medicine ball
      throw, vertical jump, and Wingate testing. Twenty-four hours following visit 1, participants
      will return to the HPL for visit 2 where they will undergo a second familiarization session
      for the isokinetic testing and Wingate testing only - these two tests require individuals to
      provide maximal physical efforts and research suggests that participants should perform
      multiple familiarization trials before beginning experimental trials. At least 72 hours
      following visit 2, participants will return to the HPL for visit 3 to perform the baseline
      performance assessments. Following the baseline assessments, participants will be divided
      into two supplementation groups: creatine and placebo (maltodextrin). These groups will be
      randomized and matched based on body mass, hours of dance training per week, meat intake, and
      menstrual cycle phase. Participants will be asked to consume one of the two supplements daily
      for 42 consecutive days and maintain their regular dance training and eating behaviors.
      Participants will report to the HPL daily to receive their supplement between the hours of
      12pm and 2pm. Following the last day of supplement consumption, participants will report to
      the HPL to perform post-testing assessments which will be identical to pre testing.
    


Intervention name(s): Creatine; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participants will consume 0.1g/kg body weight of creatine with 0.1g/kg body weight of maltodextrin for 42 consecutive days; Participants will consume 0.2g/kg body weight of maltodextrin for 42 consecutive days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: creatine, body composition, dancer, cognition