bioihbjkbjnl/mcl2 huggingface dataset:
Pain and Anxiety Control During Traditional Mandibular Anesthesia in Children Using Distracting Tools
Condition: Inferior Alveolar Nerve Block
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effectiveness of two different audiovisual
      distraction techniques (Audio Video eyeglasses "VR BOX"/ Tablet) in the management of anxious
      pediatric patients during inferior alveolar nerve block

      Group A (Control group): IAN will be administrated with basic behavior guidance techniques
      and without using any type of distraction aids.

      Group B: IAN will be administrated with using AV eyeglasses "VR BOX" and wireless headphone.

      Group C: IAN will be administrated with using tablet device and wireless headphone

      All of the children who experienced an inferior alveolar block with/without distraction will
      be assessed by using a combination of measures: Wong-Baker FACES (self-report), pulse rate
      (physiological) and behavior (using FLACC behavior rating scale "external evaluator
    

Detailed description: 
      This study will evaluate the effectiveness of two types of distraction aids that contain
      video using (tablet device or VR BOX eyeglasses) and audio distraction using wireless
      headphone. pain and anxiety will be evaluated during inferior alveolar nerve block using
      three behavioral scales, Wong-Baker FACES (self-report), pulse rate (physiological) and
      behavior (using FLACC behavior rating scale "external evaluator".

      The first measure of heart pulse rate will be recorded directly when the patient seated
      comfortably on the dental chair, after anesthesia, the second heart pulse rate will be taken
      and the child patients will ask to choose a face that describe their status from one of the
      Wong Baker faces scale.

      For each child patient, all of the body responses will be recorded during the whole procedure
      and then will be evaluated by an external assessor to determine the children behavioral score
      according to FLACC scale.
    

Intervention name(s): VR Box; Tablet Device; Anesthesia
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): Distraction will be made during the injection of the drug using this method.; Distraction will be made during the injection of the drug using this method; Anesthesia will be obtained by injecting the drug into the oral mucosa before performing the dental treatment.
Other intervention name(s): Virtual Reality Eyeglasses
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Relative Bioavailability Study of Peresolimab (LY3462817) Formulations in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to look at the amount of the study drug, peresolimab, that
      gets into the blood stream and how long it takes the body to get rid of it when given under
      the skin using test formulations versus reference formulation in healthy participants. The
      study will also evaluate the safety and tolerability of peresolimab and information about any
      side effects experienced will be collected. For each participant, the total duration of the
      study will be approximately up to 17 weeks, including screening.
    


Intervention name(s): Peresolimab
Intervention type(s): Drug
Intervention description(s): Administered SC
Other intervention name(s): LY3462817
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Anlotinib for Advanced and Refractory Natural Killer /T-cell Lymphoma
Condition: Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of anlotinib in patients
      with stage IV extranodal natural killer/T-cell lymphoma, nasal type.
    

Detailed description: 
      Extranodal natural killer/T-cell lymphoma (ENKTCL), nasal type, is a rare subtype of
      non-Hodgkin lymphoma (NHL) with relatively high incidence in China. L-asparaginase based
      chemotherapy improved overall response and prolonged the long-term survival for patients with
      stage IV. But the treatment for the patients with advanced disease and resistant to
      L-asparaginase based chemotherapy has not been established. The overall survival for these
      patients are very poor. This study is designed to evaluate the efficacy and safety of
      anlotinib in patients with stage IV ENKTCL and refractory to L-asparaginase based
      chemotherapy.
    

Intervention name(s): Anlotinib
Intervention type(s): Drug
Intervention description(s): 12 mg daily for continus 14 days every 21 days
Other intervention name(s): Anlotinib Hydrochloride
Intervention model: Single Group Assignment
Intervention model description: drug
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: anlotinib; L-asparaginase resistant
A Study of LY2605541 and Glargine in Participants With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This study has 2 parts. Each participant will receive a daily injection of LY2605541 during
      one treatment period and a daily injection of insulin glargine during one treatment period.
      Each treatment period is 2 to 3 weeks and is followed by a procedure to lower blood sugar
      levels to see how the body recovers after each treatment.
    


Intervention name(s): LY2605541; Insulin Glargine
Intervention type(s): Biological; Biological
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Phase I Study to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of CJ-12406 in Healthy Male Subjects
Condition: Digestive System Diseases
MeSH terms: Digestive System Diseases; Gastrointestinal Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Study objectives

        -  To evaluate the safety, tolerability, and pharmacokinetics of escalating single oral
           doses of CJ-12406 in healthy male subjects.

        -  To evaluate the pharmacodynamics of CJ-12406 after multiple oral administrations to
           healthy male subjects.

        -  To evaluate the effect of food on the pharmacokinetic of a single oral dose of CJ-12406
           in healthy male subjects.
    


Intervention name(s): Placebo; CJ-12406
Intervention type(s): Drug; Drug
Intervention description(s): single and multiple dose; single and multiple dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Assessment of the Effect of PAP on Energy and Vitality in Mild OSA Patients: The Merge Study
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The investigators wish to prospectively determine the response to CPAP in patients presenting
      with mild OSA. In many healthcare systems, patients with mild OSA (AHI 5-15) are not
      reimbursed for treatment. Although some evidence exists of the benefits of treating mild OSA
      when scoring as per AASM 2007 criteria, more evidence is needed. The investigators wish to
      add to this pool of knowledge and also increase the inclusion criteria to include the AASM
      2012 definition of mild OSA. By including the 2012 AASM definition of mild OSA, the
      investigators will add novel information to the field by assessing the benefits of treatment
      in both sub-groups of mild OSA.
    

Detailed description: 
      Patients who visit their local sleep service for OSA investigation, and are found to have
      mild OSA (AHI ≤ 15) from an Apnealink polygraphy (PG) home sleep test, scored as per AASM
      2007 and/or AASM 2012, will be invited to take part in the study (pre-screening).

      At the study visit, informed consent, baseline demographics, and standardised questionnaires
      will be administered. Participants will then be randomised to a CPAP treatment group or
      control group.

      After 3 months, participants will be asked to repeat the standardised questionnaires, the
      trial will then be complete and they will return to routine clinical care.
    

Intervention name(s): Continous Positive Airway Pressure; Control Group
Intervention type(s): Device; Other
Intervention description(s): CPAP refers to the application of positive airway pressure through a mask and tubing to splint a patients throat open at night. CPAP is considered standard treatment for OSA; Standard sleep hygiene counseling as per published guidelines
Other intervention name(s): CPAP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Uterus Transplantation From Live Donors With Robotic Assisted Surgery - Gothenburg II
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Observational [Patient Registry]

Summary: 
      The study is a follow up of NCT01844362. Uterus transplantation will be performed from live
      donors to patients with uterine factor infertility. If will be performed before
      transplantation. Organ procurement from the donor will be performed by robotic assisted
      laparoscopy. Transplantation will be by laparotomy. Embryo transfer will be done 10-12 months
      after transplantation. After birth of 1-3 children the uterus will be removed by
      hysterectomy,
    

Detailed description: 
      The study is a follow up of NCT01844362. Uterus transplantation will be performed from live
      donors to patients with uterine factor infertility. If will be performed before
      transplantation. Organ procurement from the donor will be performed by robotic assisted
      laparoscopy. Transplantation will be by laparotomy. Embryo transfer will be done 10-12 months
      after transplantation. After birth of 1-3 children the uterus will be removed by
      hysterectomy.
    

Intervention name(s): uterus transplantation
Intervention type(s): Procedure
Intervention description(s): Uterus transplantation from live donor
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        absolute uterine factor infertile women > 38 years
      
Biospecimen description: 
      blood, endometrial tissue, cervical tissue, placental tissue
    
Keywords: infertility, uterus, transplantation
Fish Oil and Inflammation in Overweight Subjects
Condition: Overweight
MeSH terms: Overweight; Inflammation
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effects of acute and short-term intervention with
      fish oil on inflammatory markers in overweight subjects.
    

Detailed description: 
      Being overweight is associated with metabolic syndrome, cardiovascular disease, and diabetes
      mellitus (type 2). Adipose tissue can be regarded as an active organ, which produces an array
      of inflammatory mediators. This creates a state of chronic low-grade inflammation.
      Inflammation has been proven to be a key element in the development of atherosclerotic
      plaques.

      The marine n-3 polyunsaturated fatty acids (PUFAs) have beneficial effects on cardiovascular
      disease. These effects are partly attributed to the anti-inflammatory effect of the n-3
      PUFAs.

      Previous studies have shown an anti-inflammatory effect of n-3 PUFAs in overweight subjects,
      but the studies have been conducted with a high daily dose of n-3 PUFA. We want to examine
      the effect of a lower dose of 1 g n-3 PUFA/day (the dose recommended by the Danish Heart
      Foundation).

      The study is randomized, placebo-controlled and double blinded. Fifty subjects aged 30 - 75
      years (postmenopausal women; waist circumference > 80 cm and men; waist circumference > 94
      cm) will be included.

      Blood samples and fatty tissue biopsies will be collected at baseline, after 1 day and after
      6 weeks.
    

Intervention name(s): fish oil; olive oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Capsules. Approximately 1000 mg n-3 PUFA daily. One day + 6 weeks; Capsules. Approximately 1 g olive oil daily. One day + 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Inflammation; Fatty acids, Omega 3; Leukotrienes; Adiponectin; Adipose tissue; RNA, Messenger
Safety, Tolerability, and Pharmacodynamics of RDX5791 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, single-center, randomized, double-blind, placebo-controlled study to evaluate the
      safety, tolerabiltiy, and pharmacodynamics of different multiple dose regimens of RDX5791 in
      healthy volunteers.
    

Detailed description: 
      The starting doses for this study are based on the results from the multiple ascending-dose
      study performed on RDX5791 (Protocol RDX5791-101). Subjects will be screened within 3 weeks
      of check in to the CPU. Each cohort of 15 subjects (12 RDX5791, 3 placebo) will check in to
      the CPU on Day -5 before dinner. Each subject will receive a diet standardized for Na+
      content while in the CPU. Subjects will receive doses of RDX5791 with approximately 240 mL of
      non-carbonated water on Days 1 to 7 (just prior to meals, depending on QD, bid, or tid
      regimens). Subjects will be provided standardized meals within 10 minutes after dosing. Doses
      can be administered with breakfast, lunch, or dinner.
    

Intervention name(s): RDX5791; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Placebo
Other intervention name(s): Tenapanor; AZD1722
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Phase I; Healthy; Pharmacodynamics
A Study of Fabrazyme in Pediatric Patients With Fabry Disease
Condition: Fabry Disease
MeSH terms: Fabry Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      People with Fabry disease have an alteration in their genetic material (DNA) which causes a
      deficiency of the a-galactosidase A enzyme. This enzyme helps to break down and remove
      certain types of fatty substances called "glycolipids". These glycolipids are normally
      present within the body in most cells. In people with Fabry disease, glycolipids build up in
      various tissues such as the liver, kidney, skin, and blood vessels because a-galactosidase A
      is not present, or is present in small quantities. The build up of glycolipid levels (also
      referred to as "globotriaosylceramide" or "GL-3") in these tissues is thought to cause the
      clinical symptoms that are common to Fabry disease. Symptoms commonly appear during childhood
      with pain in the hands and feet. This study explored the safety, efficacy and
      pharmacokinetics of Fabrazyme in pediatric patients aged between 7 and 15 years.
    


Intervention name(s): Fabrazyme (agalsidase beta)
Intervention type(s): Biological
Intervention description(s): 1 mg/kg every 2 weeks
Other intervention name(s): r-hαGAL
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: a-Galactosidase A; aGal; r-haGAL; Fabry; GL-3; Fabrazyme
AZD7325 Proof of Concept in Patients With Generalized Anxiety Disorder (GAD)
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to determine whether AstraZeneca's drug AZD7325 is safe
      and effective in the treatment of generalized anxiety disorder.
    


Intervention name(s): AZD7325; AZD7325; AZD7325; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2 tablets taken twice a day for 28 days; 2 tablets taken twice a day for 28 days; 2 tablets taken twice a day for 28 days; 2 tablets taken twice a day for 28 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Generalized Anxiety Disorder; GAD; Anxiety
Gait Training in Patients With Burn Injury
Condition: Burns; Gait Training; Physical Functions
MeSH terms: Burns
Study type: Interventional

Summary: 
      Twenty-four individuals with burn injury will be included in this study. Participants with
      burn injury will evaluate with the following assessment tools: Demographic datas; age,
      gender, height, body mass index; burn caharacteristics; type of burn injury, degree of burn
      injury, localization of burn injury and total burn surface area will be recorded. Gait
      parameters (step length, stride length, base support, step time, cycle time, cadence,
      velocity, single support, double support, swing ( % of gait cycle) and stance (% of gait
      cycle). will be recorded via GAITRite system.
    

Detailed description: 
      Twenty-four individuals with lower extremity burn injury will be included in this study.
      Participants will be included if they are aged of 18-50, able to walk independently at least
      10 meters.

      Participants will be divided in two groups; Intervention and control groups. Intervention
      group: standart rehabilitation program and gait training on the overground will be applied.

      Conntrol Group:standart rehabilitation program and gait training on the treadmill will be
      applied.

      Rehabilitation program will applied by physiotherapist during the acute hospitalization.
      Standart rehabilitation will include active range of motion exercises, functional mobility,
      balance activities.

      Participants will evaluate with the following assessment tools: Demographic datas; age,
      gender, height, body mass index; burn caharacteristics; type of burn injury, degree of burn
      injury, localization of burn injury and total burn surface area will be recorded. GAITRite
      system for gait parameters (step length, stride length, base support, step time, cycle time,
      cadence, velocity, single support, double support, swing ( % of gait cycle) and stance (% of
      gait cycle), timed up and go test (TUG) for dynamic balance and six minute walk test (6MWT)
      for exercise capacity, will be used. These evaluations will be made twice; initial
      (admission) and final (discharge).
    

Intervention name(s): Gait Training
Intervention type(s): Other
Intervention description(s): Gait Training: Training will be applied by a physiotherapist on a treadmill or on an overgorund.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Burn injury; Gait; Physical Function
Changes in Everydaylife Activity of Children With CP During HABIT-ILE
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      Studying in a RCT the changes in everyday llife activities of children with CP during
      HABIT-ILE or control period, changes being scored by parents and by experts.
    

Detailed description: 
      Studying in a RCT the changes in everyday llife activities of children with CP (unilateral
      and bilateral) during HABIT-ILE or control period, changes being scored by parents and by
      experts on ABILHAND-Kids, the PEDI, the ACTIVLM-CP and the COPM. Investigate neuroplastic
      changes and correlation with everyday life changes.
    

Intervention name(s): HABIT-ILE; Control
Intervention type(s): Other; Other
Intervention description(s): Hand and arm bimanual intensive therapy including lower extremities; Usual customary care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: motor skill learning; functional changes; neuroplastic changes
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Applied to Platinum-Resistant Recurrence of Ovarian Tumor
Condition: Ovarian Epithelial Cancer Recurrent; Platinum-resistant
MeSH terms: Carcinoma, Ovarian Epithelial
Study type: Interventional

Summary: 
      Patients with first recurrent resistance ovarian cancer and disease progression with
      peritoneal carcinomatosis will undergo PIPAC procedure. The primary end point is to determine
      the clinical benefit rate (CBR) of a pressurized intraperitoneal aerosol chemotherapy with a
      combination of cisplatin and doxorubicin.
    

Detailed description: 
      This study aims to investigate the therapeutic efficacy of PIPAC using cisplatin and
      doxorubicin in women with first recurrent resistance ovarian cancer and disease progression
      with peritoneal carcinomatosis. The primary objective of this study is to determine the
      Clinical Benefit Rate (CBR) according to RECIST/GCOG criteria after three cycles of PIPAC
      with PIPAC cisplatin and doxorubicin
    

Intervention name(s): Pressurized intraperitoneal aerosol chemotherapy with cisplatin and doxorubicin
Intervention type(s): Device
Intervention description(s): After insufflation of a 12 mmHg of capnoperitoneum at 37 °C, two balloon trocars will be placed. Parietal biopsies will be taken and ascites (< 500cc) will be removed. A nebulizer will be connected to a high-pressure injector and will be inserted into the abdomen through a trocar. A pressurized aerosol containing cisplatin at a dose of 10.5 mg/m2 body surface in 150 ml NaCl 0.9 % followed by doxorubicin at a dose of 2.1 mg/m2 body surface in a 50 ml NaCl 0.9% solution will be applied via a nebulizer immediately. Then, the system will be kept in steady-state for 30 min (i.e.: application time).
Other intervention name(s): PIPAC
Intervention MeSH terms: Doxorubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Relationship Between the Surgery-related Anxiety and HRV: Prediction for Aggressive Emergence Behavior
Condition: Closed Reduction Surgery for Nasal Bone Fracture
MeSH terms: Fractures, Bone
Study type: Observational

Summary: 
      Heart rate variability (HRV) is known to reflect the balance of autonomic nervous system.
      Anxiousness, which tend to result from the deficient action of parasympathetic nervous
      system, likely to show low HRV. This study is to investigate the relationship between the
      surgery-related anxiety and the HRV which is known to reflect the balance of autonomic
      nervous system. Furthermore, this study also focuses on HRV's role as a predictor for
      aggressive emergence behavior, which might also be considered as partially related to
      imbalance of autonomic nervous system.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        20-60 years old male, ASA 1-2, scheduled for elective closed reduction for nasal bone
        fracture.
      
Keywords: Emergence agitation, Heart rate variability (HRV)