bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Insomnia Treatment on Metabolism in Patients With Depression
Condition: Insomnia Chronic; Insomnia; Insomnia, Primary; Depression; Depressive Symptoms
MeSH terms: Sleep Initiation and Maintenance Disorders; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This project will examine changes in metabolism and depressive symptoms after receiving CBT-I
      in 30 subjects with insomnia disorder and MDD.
    


Intervention name(s): Cognitive Behavioral Therapy for Insomnia (CBT-I)
Intervention type(s): Behavioral
Intervention description(s): Subjects receive 6-8 CBT-I sessions in an individual format.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Metabolism; Metabolomics
Clinical Pharmacology of FYU-981 (Effect on QT/QTc Interval)
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      A Placebo-controlled, Four Way Crossover Study to Investigate the Effect on QT/QTc Interval
      of a Single Dose of FYU-981, Compared with Placebo, Using Moxifloxacin as a Positive Control,
      in Healthy Male and Female Volunteers.
    


Intervention name(s): FYU-981; Placebo; Moxifloxacin; Moxifloxacin Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Moxifloxacin; Dotinurad; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Male and Female Volunteers
Silver Diamine Fluoride Versus Sodium Fluoride Varnish With Parental Behavior Modification in Arresting Early Childhood Caries
Condition: Early Childhood Caries
Study type: Interventional
Phase: Phase 3

Summary: 
      Arresting dental caries using silver diamine fluoride (SDF) has gained attention recently for
      the management of early childhood caries (ECC). However, black staining is one of its
      drawbacks. A possible affordable alternative can be Sodium Fluoride (NaF) supported with good
      oral hygiene induced by parental Motivational Interviewing (MI).

      The trial aims to compare the impact of SDF versus NaF supported by MI on lesion activity in
      preschool children.
    


Intervention name(s): Sodium Fluoride Varnish (5%); Motivational Interviewing; SDF
Intervention type(s): Drug; Behavioral; Drug
Intervention description(s): Applied at baseline; Two MI sessions: face-to-face at baseline and phone call at 3 months; Applied bianually
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride; Fluorides, Topical
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: ECC; 38% SDF; 5% NaF; Motivational Interviewing; Preschoolers
Effects of Fermented Red Clover on Muscle Strength and Muscle Mass
Condition: Estrogen Deficiency
Study type: Interventional

Summary: 
      The project is designed as a randomized controlled, double-blinded, cross-over trial,
      including 10 healthy postmenopausal women consuming fermented red clover extract or placebo
      twice daily over a two-week period. After the first trial (two weeks), participants will
      undergo a two-week washout period, after which they will receive the opposite trial drink for
      two weeks. The trial period runs over six weeks. Before each of the two trial rounds,
      participants will meet in the laboratory and perform muscle strength tests (trial days 1 and
      3). After each trial round (trial days 2 and 4), participants will meet fasting in the
      laboratory, and a blood test and a muscle biopsy will be taken initially. Next, the subject
      consumes the test drink (placebo or red clover extract) before the subject performs a
      strength training session with one leg. Right after the training session, the subject
      consumes a protein drink. Three hours after the protein drink, another muscle biopsy is
      taken. During the period from the protein drink to the final biopsy, the subject performs two
      muscle strength tests (respectively grip strength and maximum upper arm muscle strength
      (biceps)). The primary target parameter is muscle protein signaling measured in the muscle
      tissue samples using the western blotting method.
    


Intervention name(s): Red clover; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 weeks of Red clover; 2 weeks of Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Isoflavones; Red clover; Muscle Function; Postmenopausal women
Effects of Bariatric Surgery in Swedish Obese Subjects
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of the Swedish Obese Subjects (SOS) study is to examine the long-term effects of
      bariatric surgery on overall mortality and obesity-related co-morbidities.
    

Detailed description: 
      The Swedish Obese Subjects (SOS) study is a prospective non-randomized controlled
      intervention study designed to examine the long-term effects of bariatric surgery compared to
      usual care in obese subjects.
    

Intervention name(s): Bariatric surgery; Usual care
Intervention type(s): Procedure; Other
Intervention description(s): Gastric banding, vertical banded gastroplasty, gastric bypass; Non-surgical obesity treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; bariatric surgery; weight loss
A Study of MK0653A (Ezetimibe (+) Simvastatin) in Patients With Hypercholesterolemia (0653A-038)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the lipid lowering effects of an investigational
      drug in patients with hypercholesterolemia (high cholesterol).
    

Detailed description: 
      The duration of treatment is 4 months.
    

Intervention name(s): MK0653A, ezetimibe (+) simvastatin; Comparators: simvastatin and ezetimibe
Intervention type(s): Drug; Drug
Intervention MeSH terms: Simvastatin; Ezetimibe; Ezetimibe, Simvastatin Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Primary hypercholesterolemia
CD19/CD20 Dual-CAR-T in B-cell Lymphoma Patients
Condition: B-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, single arm, open-label, phase I study to evaluate the safety and
      efficacy of CD19/CD20 Dual-CAR-T cells in patients with refractory and relapsed B-cell
      lymphoma.
    

Detailed description: 
      This Phase I study is designed as a pilot trial evaluating the safety and efficacy of
      CD19/CD20 Dual-CAR-T cell therapy in subjects with refractory and relapsed B cell lymphoma.
      Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on
      days -5, -4 and -3 followed by infusion of CD19/CD20 Dual-CAR-T cells. Safety and efficacy of
      CD19/CD20 Dual-CAR-T cells therapy will be monitored. The purpose of current study is to
      determine the clinical efficacy and safety of CD19/CD20 Dual-CAR-T cells therapy in patients
      with refractory and relapsed B-cell lymphoma.
    

Intervention name(s): CD19/CD20 Dual-CAR-T cells
Intervention type(s): Biological
Intervention description(s): CD19/CD20 Dual-CAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of CAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest at least for 2 days before infusion. CD19/CD20 Dual-CAR-T cells will be intravenously infused with a escalated dose of 1-6×106 cells/kg.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Assess the Effect of Exenatide Treatment on Mean 24-Hour Heart Rate in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will explore the effect of exenatide (given twice a day) versus placebo (given
      twice a day) treatment on change in mean 24-hour heart rate over a 12 week period of drug
      exposure in patients with type 2 diabetes.
    


Intervention name(s): exenatide; placebo
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous injection, 5mcg or 10mcg, twice a day; subcutaneous injection, volume equivalent to active, twice a day
Other intervention name(s): Byetta; AC2993; LY2148568
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: exenatide; Byetta; type 2 diabetes; heart rate; Amylin; Lilly
The Effect of Subsartorial Saphenous Block on Postoperative Pain Following Major Ankle and Hind Foot Surgery
Condition: Arthrosis; Arthritis
MeSH terms: Osteoarthritis; Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The study investigates the effect of a ultrasound-guided subsartorial saphenous block on
      postoperative pain following major ankle and hind foot surgery.
    

Detailed description: 
      Major ankle and hind foot surgery causes intense postoperative pain. Implementation of
      continuous sciatic catheters has been a great success in reducing postoperative pain
      following these operations, but despite an effective sciatic catheter patients still report
      moderate to severe pain from the anteromedial side of the ankle. According to cadaver
      dissection studies the saphenous nerve innervates the anterior and medial parts of the ankle
      and talonavicular joint, and even though a saphenous block is standard procedure in many
      departments of anesthesiology worldwide, scientific evidence regarding the effect of the
      saphenous block on postoperative pain is lacking.

      This study investigates the effect of a selective, ultrasound-guided subsartorial saphenous
      block on postoperative pain following major ankle and hind foot surgery.
    

Intervention name(s): Bupivacaine-epinephrine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 50 mg bupivacaine and 50 μg adrenalin; 9 mg sodium chloride pr. ml (0,9 %)
Other intervention name(s): Marcain-adrenalin (combination drug); Marketing Authorisation Holder: AstraZeneca; Marketing Authorisation number: 10213; Sodium chloride solution
Intervention MeSH terms: Epinephrine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effect of Etomidate on Hemodynamics and Adrenocortical Function After Cardiac Surgery
Condition: Coronary Artery Disease; Mitral Valve Regurgitation
MeSH terms: Coronary Artery Disease; Mitral Valve Insufficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effect of a single dose of etomidate for
      patients undergoing cardiac surgery with the use of cardiopulmonary bypass (CPB) on post-CPB
      adrenocortical responsiveness, on requirements of hemodynamic support, and on use of
      intensive care resources.
    


Intervention name(s): Etomidate; Propofol; Hydrocortisone; NaCl 0.9%; Tetracosactin
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): Single induction dose of etomidate 0.2%; total dose 0.15 mg/kg; Single induction dose of propofol 2%; total dose 1.5 mg/kg; Hydrocortisone 100 mg/2 ml: day of operation 3x, POD 1 2x, POD 2 1x; NaCl 0.9% 2 ml; day of operation 3x, POD 1 2x, POD 2 1x; Diagnostic test, Tetracosactin 250 microg iv
Intervention MeSH terms: Hydrocortisone; Propofol; Etomidate; Cosyntropin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Etomidate; Propofol; Adrenocortical Insufficiency; Hemodynamic Process; Vasoactive Agonists; Coronary Artery Bypass; Ischemic Coronary Heart Disease; Mitral valve reconstruction/replacement; Mitral valve regurgitation; Heart Valve Prosthesis; Cardiopulmonary Bypass
Positional Distraction and Stabilization Exercises in Adults With Lumbar Radiculopathy.
Condition: Lumbar Radiculopathy
MeSH terms: Radiculopathy
Study type: Interventional

Summary: 
      This study evaluate the addition of positional distraction to stabilization exercises in the
      treatment of lumbar radiculopathy in adults. Half of the patients will recieve positional
      distraction and stabilization exercises in combination, while the other half will recieve
      stabilization exercises only.
    

Detailed description: 
      In positioanl distraction making use of the body position to produce traction at an isolated
      spinal level to maximally open the affected neuroforamen. It is an alternative to lumbar
      mechanical traction.

      The spinal level of vertebral level requiring traction is palpated and a soft roll is placed
      and the patient side lies on the unaffected side. For further distraction both hips are
      flexed until movement is noted at the spinal level needing traction.

      Further, distraction applied by rotating upper trunk to opposite side of pain.

      Stabilization exercises are mainly used for the stability of joints and for improving muscle
      strength.

      The first step of lumbar stabilization exercises are to maintain functional back positions
      during all activities. The second step is to improve strength and endurance of the core
      muscles.
    

Intervention name(s): physical therapy treatment
Intervention type(s): Other
Intervention description(s): the experimental group received positional distraction plus stabilization exercises and the control group received stabilization exercises only.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All the patients will be randomly allocated into treatment and control groups 50 in experimental and 50 in control group. The treatment group will receive positional with stabilization exercises while the control group will be treated with stabilization exercises only.
Masking: Single (Participant)
Primary purpose: Prevention
A Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine
Condition: Basilar Migraine
MeSH terms: Migraine Disorders; Migraine with Aura
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to assess the long-term safety and effectiveness of topiramate
      in the prevention of basilar and hemiplegic migraine in children and adolescents.
    

Detailed description: 
      This is a single-center, open-label study consisting of 3 phases: Blinded Transition Phase,
      Open-Label Maintenance Phase, and Taper/Exit Phase. Subjects who have either succesfully
      completed the CAPSS-271 protocol or who discontinued the CAPSS-271 study due to lack of
      effectiveness after completing at least 2 weeks of maintenance treatment will be eligible to
      enroll.
    

Intervention name(s): Topiramate
Intervention type(s): Drug
Intervention MeSH terms: Topiramate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Educational/Counseling/Training
Keywords: Basilar/Hemiplegic Migraine; Prophylaxis
Multi-omics Analysis of Women With PCOS and Obesity Compared With Non-PCOS Obese Controls
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Obesity
Study type: Observational [Patient Registry]

Summary: 
      Polycystic ovary syndrome (PCOS) is a common endocrine and metabolic disorder in
      reproductive-aged women， which associated with increased risks to develop metabolic
      disorders, including cardiovascular diseases, diabetes mellitus, and cerebrovascular
      diseases. The precise pathogenesis of PCOS remains unknown but is thought to be
      multifactorial, comprising genetic and environmental factors .
    

Detailed description: 
      To study the pathogenesis of diseases, the study of multi-omics approach has been applied in
      various diseases researching . Obesity and PCOS are both metabolic disorders, and both have
      an impact on metagenomics, metabolomics and transcriptome. Currently, multi-omics studies
      based on obese PCOS are still limited. Therefore, this study tried to use a multi-omics
      approach that integrates the gut microbiome, serum metabolomics, serum transcriptomics, and
      clinical indicators to distinguish obese PCOS from obese non-PCOS women. To investigate
      whether the specific composition of the gut microbiome is associated with PCOS in obese
      women. Serum metabolomics and transcriptomics were analyzed to explore potential metabolic
      pathways. Meanwhile, gut microbiome and serum metabolomics are used to predict the occurrence
      of PCOS. Then, a new metabolite that could predict PCOS were tested on female mice with high
      fat diet (HFD).
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study enrolled 63 PCOS women with obesity and 58 age- and body mass index
        (BMI)-matched subjects with normal menstrual cycles who were admitted to the Department of
        Endocrinology, Shanghai Tenth People's Hospital, between April 2019 and November 2022.
      
Biospecimen description: 
      Metabolome Serum Sample Collection，Transcriptome RNA sample collection and Stool specimen
      collection
    
Keywords: Gut microbiome; metabolomics; transcriptomic; obesity
Relevance of the Ethanol Dose in the Generation of Endogenous Hydroxytyrosol
Condition: Contribution of Ethanol on Hydroxytyrosol Formation
Study type: Interventional
Phase: Phase 1

Summary: 
      Health benefits for humans derived from low dose intake of ethanol could partially be
      explained by its interaction with dopamine (DA) oxidative metabolism. Ethanol is expected to
      induce an increase in the formation of a DA minor metabolite: DOPET (hydroxytyrosol).
      Hydroxytyrosol is one of the most potent antioxidants present in Mediterranean Diet. The
      study is aimed at establishing the contribution of ethanol on hydroxytyrosol formation.
    


Intervention name(s): Ethanol; Water
Intervention type(s): Dietary Supplement; Other
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Antioxidants, Central Nervous System Agents
Patient Education in Children With Functional Gastrointestinal Disorders
Condition: Functional Gastrointestinal Disorders
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional

Summary: 
      This pilot-study aims to evaluate the effect size and feasibility of patient education for
      children and adolescents (age 8-17 years) with pain-predominant functional gastrointestinal
      disorders (irritable bowel syndrome, functional abdominal pain and functional dyspepsia
      according to the Rome III criteria).
    

Detailed description: 
      The patient education will be provided in a group setting and the children will participate
      along with one of their parents. Education consists of 2-hour long group sessions, given at 2
      different occasions within a month.

      The hypothesis is that patient education will reduce gastrointestinal symptoms and pain and
      also improve quality of life in this group of patients.
    

Intervention name(s): Patient education program
Intervention type(s): Behavioral
Intervention description(s): The education program provides information and guidance concerning aetiology, diagnostics and treatment of pain-predominant functional gastrointestinal disorders. The patient education program will be provided in a group setting and the children will participate along with one of their parents. The participants (n=20) will be divided into two groups consisting of ten child-parent pairs. Two lectures will be held, two weeks apart, two hours per lecture. Represented teachers are physician, psychologist and dietician.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Use of the Scolioscan for Quantitative Evaluation of Spinal Deformity - A Validity Study on Patients With Scoliosis
Condition: Scoliosis
MeSH terms: Scoliosis; Congenital Abnormalities
Study type: Interventional

Summary: 
      The purpose of the study is to investigate the validity of Scolioscan for quantitative
      assessment of curve severity in scoliosis using x-ray radiographs as the gold standard.
    

Detailed description: 
      Scoliosis is a three dimensional spinal deformity, in both the coronal plane, sagittal and
      transverse planes. Quantitative assessment of curve severity in scoliosis is important for
      patient management. At present, Cobb angle measurement in the frontal plane using standing
      postero-anterior X-ray radiograph is the gold standard for scoliosis evaluation. Taking x-ray
      involves irradiation and is not without risk especially over repeated exposures for follow-up
      visits. With advancement of ultrasound technology which is radiation-free and noted to be
      useful as a tool for musculoskeletal imaging, an ultrasound system designed for evaluation of
      spinal deformity called Scolioscan has been developed. It comprises of a freehand 3D
      ultrasound imaging system with an enhanced frame structure for supporting the patient to
      maintain the posture during scanning and a software for measuring curve deformity in terms of
      Cobb angles. Previous studies on validity of ultrasound assessment for back deformity
      involved a pilot group of subjects. Based on these promising pilot results, we plan to carry
      out a formal study to investigate the validity of Scolioscan for quantitative assessment of
      curve severity in scoliosis using x-ray radiograph as the gold standard for comparison.
    

Intervention name(s): Scolioscan (Ultrasound imaging system)
Intervention type(s): Other
Intervention description(s): To assess the scoliotic patient, a 3D ultrasound imaging system (the Scolioscan) was developed. The system composes of an ultrasound scanner with a linear probe, a frame structure, an electromagnetic spatial sensing device and a dedicated PC program for imaging and data collection, processing, visualization, analysis, and assessment. The spatial sensor was attached to the ultrasound probe for spatial information collection and calibration. The Scolioscan will generate ultrasound images of the spine for quantitative assessment of the curve deformity in terms of Cobb angles.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: scoliosis; spinal deformity; Cobb angle; assessment; ultrasound