bioihbjkbjnl/mcl2 huggingface dataset:
Quality of Vision in Implantable Collamer Lens (ICL)
Condition: Pupil Diameter
Study type: Observational

Summary: 
      The aim of this study is to observe the influence of pupil size upon visual outcome in
      patients with Visian Implantable Collamer Lens(ICL) and toric-ICL implantation.
    

Detailed description: 
      The aim of this study is to observe the influence of pupil size upon the quality of vision
      outcome in patients with Visian Implantable Collamer Lens(ICL) and toric-ICL implantation.
      Pre-operation and 3-month post-operation pupil size, visual acuity, quality of vision will be
      evaluated in patient that had ICL surgery.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Randomly choosen patients from the hospital records who had ICL surgery at He Eye Hospital,
        Shenyang, China during September 2019 to September 2020. They must have signed informed
        consent for their records to be used for education and research purposes before undergoing
        ICL surgery for myopic correction.
      
Keywords: ICL; QoV; Visual acuity
Protein Intake on Muscle Protein Synthesis Overnight
Condition: Protein Synthesis Overnight
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is an exploratory study in order to determine whether the ingestion of one type of
      protein (milk protein/CHO/Fat) vs.placebo (CHO/Fat) 2 hours before bed time results in the
      extension of the post-prandial window of anabolism during the night by increasing whole body
      protein balance as well as muscle protein fractional synthesis rate (FSR).
    


Intervention name(s): Milk protein; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Study product will provide 25 g of protein to subjects.; Product with no protein
Intervention MeSH terms: Caseins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Gender Differences in Response to Nicotine Replacement Therapy and De-Nicotinized Cigarettes
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate the underlying neurobiology of differences between male and
      female smokers. Research suggests that women are less responsive to nicotine replacement
      therapy (NRT) than men and more responsive to the sensory and behavioral aspects of smoking.
      This study proposed that male smokers will have a greater response to NRT demonstrated by
      reduced withdrawal symptoms, craving, and less blood-oxygen-level dependent functional
      magnetic resonance imaging (BOLD FMRI) regional brain activation in response to nicotine-cues
      as compared to female smokers treated with NRT. Additionally, female smokers will have a
      greater response to denicotinized cigarettes with decreased withdrawal symptoms, craving, and
      less BOLD fMRI activation in response to nicotine-cues as compared to male smokers.
    

Detailed description: 
      Women smokers are less responsive to nicotine replacement therapy (NRT) and more responsive
      to environmental cues associated with smoking behavior. This pilot study is designed to
      increase understanding of the neural circuitry underlying these differences. In the proposed
      study, adult male and female (10 per group) treatment-seeking nicotine-dependent individuals
      will participate in functional magnetic resonance imaging (fMRI) with the presentation of
      smoking-related cues under three conditions during a seven day period: baseline, after NRT,
      and after denicotinized cigarette facilitated-extinction. After baseline scanning, subjects
      will receive three days of 21 mg nicotine patch. Scanning procedures will be repeated on day
      3. Subjects will then receive denicotinized cigarettes for ad lib smoking on days three
      through seven. Subjects will be asked to remain abstinent throughout the study period and
      they will be assessed daily with self-report, Carbon Monoxide (CO) monitor and for nicotine
      withdrawal.
    

Intervention name(s): nicotine patch (Nicoderm Committed Quitter (CQ), Habitrol); denicotinized cigarettes (Quest 3 cigarettes)
Intervention type(s): Drug; Other
Intervention description(s): Nicotine patch 21 mg every 24 hours will be utilized for the three days after the first scanning session.; Cigarettes that contain trace levels of nicotine (less than .05 mg per cigarette) will be utilized ad lib in the study for 4 days after the nicotine patch.
Other intervention name(s): Nicoderm Committed Quitter (CQ); Habitrol; nicotine transdermal system; NRT; Quest 3 cigarettes
Intervention MeSH terms: Nicotine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gender; nicotine dependence; nicotine replacement therapy; extinction; denicotinized cigarettes
Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Subjects (Food Effect Study)
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the effect of food on the pharmacokinetics of oral edaravone in healthy adult
      subjects. In this study, we determined 5 different dietary conditions including 4 different
      meal contents and fasting condition.
    


Intervention name(s): MT-1186
Intervention type(s): Drug
Intervention description(s): A crossover study in which Japanese healthy subjects receive a single dose of MT-1186 under several dosing condition on Day 1, 3, 5, 7 and 24 according to their treatment sequence.
Other intervention name(s): Edaravone
Intervention MeSH terms: Edaravone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Evaluation of Experimental Heat Patch
Condition: Effects of Heat; Tolerability; Adhesiveness; Dermal Irritation
Study type: Interventional

Summary: 
      A disposable, air-activated, adhesive backed heat patch is being developed to provide
      temporary relief from minor muscular ache and joint pains associated with overexertion
      strains and sprains as well as minor pain associated with arthritis. The aim of the study is
      to determine the safety and tolerability of the patch during normal wear conditions.
    


Intervention name(s): Thermal Adhesion Patch; Marketed Thermal Adhesion Patch; Placebo Patch
Intervention type(s): Device; Device; Device
Other intervention name(s): ThermaCare Heat Wraps
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Investigation of the Effectiveness of Visual Feedback Training on Upper Extremity Functions in Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Observational [Patient Registry]

Summary: 
      The purpose of the study was to investigate the effectiveness of Cogniboard® Light Trainer,
      an education device with visual feedback that is added to the Neurodevelopmental Therapy
      Method (NDT) based upper extremity rehabilitation in children with cerebral palsy, on upper
      extremity functions such as joint range of motion (ROM), muscle tone, grip strength, pinch
      strength and functional abilities.
    

Detailed description: 
      Children with the diagnosis of Cerebral Palsy, aged between 4 and 18 years were included in
      the study, who were volunteered to participate. The participants were randomly assigned into
      two groups; A total of 16 sessions of rehabilitation program were applied for 2 days a week
      for 8 weeks. The treatment programs applied are; Group I: NDT based upper extremity
      rehabilitation, Group II: NDT based upper extremity rehabilitation + Cogniboard® Light
      Trainer training. In the cases, pre- and post-treatment spasticity was defined with 'Modified
      Ashworth Scale'; upper extremity joint range of motion (ROM) with 'goniometer'; grip and
      pinch strength with 'dynamometer'; hand skills with 'Minnesota Hand Skill Test'; functional
      abilities with 'Childhood Health Assessment Questionnaire (CHAQ) and functional level with
      'Gross Motor Function Classification System (GMFCS)'.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants of the study were selected among the children who applied to Dilbade Education
        and Rehabilitation Center for rehabilitation.

        Simple random sampling method was applied to group selection.
      
Keywords: cerebral palsy; upper extremity rehabilitation; neurodevelopmental therapy; physiotherapy and rehabilitation; visual feedback device
Clinical Study of T Cell Infusion Targeting BCMA Chimeric Antigen Receptor
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Chimeric antigen receptor T cells (car-t) is one of the most effective therapies for
      malignant tumors (especially hematological tumors). Like other immunotherapies, the basic
      principle is to use the patient's own immune cells to clear cancer cells. Chimeric antigen
      receptor (car) is the core component of car-t, which endows T cells with the ability to
      recognize tumor antigens in an independent manner, which enables car modified T cells to
      recognize a wider range of targets than natural T cell surface receptors (TCR). The basic
      design of car includes a tumor associated antigen binding region (usually derived from scFv
      segment of monoclonal antibody antigen binding region), transmembrane region and
      intracellular signal region. The selection of target antigen is a key determinant for the
      specificity and effectiveness of car and the safety of genetically modified T cells.

      BCMA is a specific surface protein of B lymphocytes, which plays an important role in the
      development, proliferation and differentiation of B cells. BCMA is highly expressed in
      malignant mm plasma cells and provides a large number of anti apoptotic signals, which makes
      bcam an ideal target in targeted immunotherapy. At present, a variety of immunotherapy
      strategies targeting BCMA are being carried out in laboratory and clinical practice, which
      have achieved encouraging therapeutic effects in multiple myeloma and effectively promoted
      the development of targeted immunotherapy.
    


Intervention name(s): T cell infusion agent targeting BCMA chimeric antigen receptor
Intervention type(s): Drug
Intervention description(s): Chimeric antigen receptor T cells (car-t) is one of the most effective therapies for malignant tumors (especially hematological tumors). Like other immunotherapies, the basic principle is to use the patient's own immune cells to clear cancer cells. Chimeric antigen receptor (car) is the core component of car-t, which endows T cells with the ability to recognize tumor antigens in an independent manner, which enables car modified T cells to recognize a wider range of targets than natural T cell surface receptors (TCR). The basic design of car includes a tumor associated antigen binding region (usually derived from scFv segment of monoclonal antibody antigen binding region), transmembrane region and intracellular signal region. The selection of target antigen is a key determinant for the specificity and effectiveness of car and the safety of genetically modified T cells.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Relationship of Sevoflurane Consumption With Metabolic Age
Condition: Sevoflurane
Study type: Observational

Summary: 
      The aim of this clinical study is to determine the consumption of sevoflurane, which is one
      of the inhalation anesthetics, with metabolic age and basal metabolic rate. The basal
      metabolic rates and metabolic ages of the patients who will be given sevoflurane- maintained
      general anesthesia were measured preoperatively. The relationship between the amount of
      sevoflurane consumption and the measured data of the patients in the postoperative period was
      examined.
    

Detailed description: 
      Standard monitoring, BIS, TOF (train of four) were performed from the premedication
      application. Aspect A 2000 (Aspect Medical Systems, Newton) monitor and single-chip BIS
      electrodes will be used for BIS. The total amount of sevoflurane consumed and MAK values of
      these components will be recorded. Chronological age, metabolic age, BMR, height, weight,
      ideal body weight, BMI, body adiposity, body fluid ratio, body fluid care, fat mass, lean
      body weight, muscle registered, visceral adiposity, obesity degree in the preoperative period
      of the patients. Values, ASA scores and demographic data will be recorded for the operation
      process, cutting time, anesthesia time, extubation time, total sevoflurane consumption
      throughout the case, and the relationship with basal metabolism and metabolic age will be
      evaluated.
    

Intervention name(s): Sevoflurane Baxter, 100%, Inhalation Vapour, Liquid 250 mL
Intervention type(s): Drug
Intervention description(s): No procedure was performed on the patient other than routine anesthesia management.We compared sevoflurane consumption amount in the patient undergoing general anesthesia with sevoflurane according to their metabolic age.
Other intervention name(s): No procedure was performed on the patient other than routine anesthesia management.
Intervention MeSH terms: Sevoflurane
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        18-65 AGE
      
Keywords: Sevoflurane Consumption, Metabolic Age, Tanita
Foot Pressure Mapping and Tendon Length After Nonoperative Treatment of Acute Achilles Tendon Rupture
Condition: Achilles Tendon Rupture
MeSH terms: Rupture
Study type: Observational

Summary: 
      Using a population of patients from another study, who was originally randomized to 2
      different types of nonoperative treatment after an acute achilles tendon rupture, the length
      of the achilles tendon is examined using ultrasound, and foot pressure mapping is performed,
      4-5 years after the injury.
    

Detailed description: 
      A total of 56 patients from an earlier study (see reference) on Achilles tendon rupture using
      nonoperative treatment with or without early weight bearing was invited for an additional
      follow up, where we examine the length of the Achilles tendon using ultrasound, as well as
      functional influence of the injury, using foot pressure mapping (FPM) during barefoot gait.
      Additionally the mobility of the ankle is measured with the Achilles Tendon Resting Angle
      (ATRA) as well as passive plantar- and dorsiflexion. Strength is measured using Heel Raise
      Work (height of lift, number of lifts and the total work), and supplemented with calf
      circumference.
    

Intervention name(s): Early weight bearing
Intervention type(s): Behavioral
Intervention description(s): The intervention implies that the selected patients, will be allowed to bear weight on the injured leg form day 1 while wearing the orthosis, in contrast to the control group, who must wait 6 weaks.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients who participated and completed the original study:

        Barfod, K.W., et al., Nonoperative dynamic treatment of acute achilles tendon rupture: the
        influence of early weight-bearing on clinical outcome: a blinded, randomized controlled
        trial. J Bone Joint Surg Am, 2014. 96(18): p. 1497-503.
      
Keywords: Achilles Tendon Rupture; Conservative treatment; early weight bearing; Achilles Tendon Length; Ultrasound; Foot Pressure Mapping; ATRA; Heel Raise Work
Vitamin D Supplementation in Breastfeeding Women
Condition: Vitamin D Deficiency; Rickets; Infant Nutrition Disorders
MeSH terms: Rickets; Vitamin D Deficiency; Nutrition Disorders; Infant Nutrition Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Adequate vitamin D is essential for proper infant growth and development. However, human milk
      is low in vitamin D, and most infants do not receive recommended supplementation. Our aim is
      to assess the feasibility of providing adequate vitamin D to breastfed infants through
      maternal vitamin D supplementation. Forty non-pregnant, lactating women at least 18 years of
      age with exclusively breastfed infants between the ages of 1 and 6 months will be randomized
      to receive oral vitamin D as either 5,000 IU daily for 28 days or 150,000 IU as a single
      dose. Maternal serum calcium, phosphorus, vitamin D and 25(OH)D; maternal urinary calcium;
      maternal milk vitamin D and 25(OH)D will be measured on days 0, 1, 3, 7, 14, and 28 of the
      study; and infant serum vitamin D and 25(OH)D will be measured on days 0 and 28.
    


Intervention name(s): Vitamin D3; Vitamin D3
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 150,000 IU orally given once; 5000 IU given orally daily for 28 days
Other intervention name(s): Cholecalciferol; Cholecalciferol
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vitamin D deficiency; Rickets; Infant; Nutrition
Lung Functions in Menopausal Obese Women After COVID 19 Recovery
Condition: Lung Function Decreased; Obesity; Menopause; Covid19
MeSH terms: COVID-19
Study type: Observational [Patient Registry]

Summary: 
      The COVID-19 pandemic has presented considerable challenges to global health services and
      dictates almost every aspect of medical practice and policy. The menopausal transition may
      have significant consequences for respiratory health as COVID 19 symptoms subsides, lung
      function testing should be done to assess the consequences of this virus on lung health
      especially in menopausal woman.
    

Detailed description: 
      The study group will consist of (40) obese menopausal women whom were recently recovered from
      mild-moderate COVID 19 for one month. The control group will consist of (40) obese menopausal
      women; whom will not affected by COVID 19. Using incentive spirometer, we will measure forced
      vital capacity FVC, forced expiratory volume FEV, Tiffano index TI and peak expiratory force
      PEF in both groups.
    

Intervention name(s): Spirometry
Intervention type(s): Device
Intervention description(s): Spirometry assesses the integrated mechanical function of the lung, chest wall, respiratory muscles, and airways by measuring the total volume of air exhaled from a full lung (total lung capacity [TLC]) to maximal expiration (residual volume [RV]). This volume, the forced vital capacity (FVC) and the forced expiratory volume in the first second of the forceful exhalation (FEV1), should be repeatable to within 0.15 L upon repeat efforts in the same measurement unless the largest value for either parameter is less than 1 L. In this case, the expected repeatability is to within 0.1 L of the largest value.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        all women will be aged from 45 to 55 years old in menopause, their BMI will be from 30 to
        34.9 kg/m2.
      
Keywords: Lung funnctions; Menopause; Obesity; Covid19
Clinical Trial of Clinical Efficiency and Safety of Ergoferon in Treatment of Influenza
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is:

        -  to assess clinical efficiency of Ergoferon for treatment of influenza

        -  to assess safety of Ergoferon for treatment of influenza

        -  to compare efficiency of Ergoferon and Tamiflu for treatment of influenza
    


Intervention name(s): Ergoferon; Oseltamivir
Intervention type(s): Drug; Drug
Intervention description(s): Safety and Efficiency of Ergoferon in treatment of Influenza; Safety and Efficiency in treatment of Influenza
Other intervention name(s): Tamiflu
Intervention MeSH terms: Oseltamivir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioavailability Study of Candesartan Cilexetil 16mg Tablet Under Fasting Conditions
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be an open-label, randomized, single dose, two-way crossover study. Each subject
      will participate in both treatment periods and will receive single oral doses of candesartan
      cilexetil (GW615775) and reference candesartan cilexetil (ATACAND™); the treatment periods
      will be separated by a washout period of at least 7 days and no greater than 14 days. This
      study aims to determine the relative bioavailability of a 16mg test formulation tablet of
      candesartan cilexetil (GW615775) compared to an 16mg reference tablet of candesartan
      cilexetil in healthy adult subjects. ATACAND is a registered trademark of the Astra/Zeneca
      group of companies.
    


Intervention name(s): Candesartan cilexetil (GW615775, Test formulation); Candesartan cilexetil (Reference treatment)
Intervention type(s): Drug; Drug
Intervention description(s): Test formulation candesartan cilexetil 16 mg will be supplied as round, biconvex white tablets with PX 16 embossed in one face and scored in the other face.; Reference treatment of candesartan cilexetil 16 mg will be supplied as round, biconvex pink tablets, scored in one face and with embossment in both faces (016 embossment in the plain face and A CH in the scored face).
Intervention MeSH terms: Candesartan; Candesartan cilexetil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Candesartan cilexetil; Healthy adult human subjects; Bioequivalence