bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Treatment With Azzalure, Restylane/Emervel Filler and Restylane Skinbooster
Condition: Facial Aesthetic Treatment
Study type: Interventional
Phase: Phase 4

Summary: 
      The efficacy and safety, as well as subject satisfaction will be evaluated after single
      treatment with Azzalure alone or Restylane/Emervel filler alone followed by repeated combined
      treatment with Azzalure, Restylane/Emervel filler and Restylane Skinbooster. Subjects will be
      followed for up to 18 months after initial treatment.
    


Intervention name(s): Azzalure; Restylane/Emervel filler; Restylane Skinbooster
Intervention type(s): Drug; Device; Device
Intervention description(s): Glabellar lines; Facial tissue augmentation; Facial skin rejuvenation
Other intervention name(s): Botulinum toxin; Hyaluronic acid; Hyaluronic acid
Intervention MeSH terms: Botulinum Toxins; abobotulinumtoxinA; Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Citalopram vs Clomipramine vs Placebo in Recurrent Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      citalopram and clomipramine are better than placebo in preventing new episodes of depression
      in patients with recurrent depression
    


Intervention name(s): Citalopram; Clomipramine; placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Citalopram; Clomipramine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Iron Depletion Therapy for Type 2 DM and NAFLD
Condition: Non-Alcoholic Fatty Liver Disease; Diabetes Mellitus
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Diabetes Mellitus
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to find out whether lowering the amount of iron in the body will
      result in less resistance to insulin and improved liver function in patients with type 2
      diabetes mellitus and non-alcoholic fatty liver disease. This may result in better diabetes
      control and/or a decrease in the amount of liver fat.
    

Detailed description: 
      Nonalcoholic fatty liver disease (NAFLD) is a common liver disease in the United States.
      NAFLD can lead to severe liver disease in some patients. Patients with NAFLD develop
      resistance to the normal action of insulin. Insulin is important for processing sugar and fat
      and increased resistance to insulin leads to fat in the liver. There is a correlation between
      the amount of iron in a person's body and the ability of insulin to work properly. Several
      small studies suggest that removal of iron may improve both diabetes and NAFLD by lowering
      insulin resistance.

      The goal of this pilot study is to determine the effect of iron depletion on insulin
      sensitivity in patients with type 2 diabetes mellitus and non-alcoholic fatty liver disease.
      This study will be performed as an ancillary P&F study to the NASH CRN; all participants will
      be recruited from the NASH CRN Database Study. Secondary outcome measures will include the
      effect of iron depletion on hepatic necroinflammation, markers of oxidative stress and
      intrahepatic fat content. Insulin resistance will be directly measured using a two-step
      hyperinsulinemic euglycemic clamp procedure, before and after iron depletion by phlebotomy.
      Oral glucose tolerance tests will also be performed in order to evaluate the efficacy of
      using the indirect, but less cumbersome, HOMA model to derive values of insulin resistance in
      this patient cohort. This study will advance our understanding of the role of body iron
      stores in the pathophysiology of type 2 diabetes mellitus and non-alcoholic fatty liver
      disease. If iron depletion results in improved insulin sensitivity, reduced hepatic
      necroinflammation and/or intrahepatic fat content, a large scale, randomized, controlled
      trial of iron depletion in patients with type 2 diabetes mellitus and non-alcoholic fatty
      liver disease will be planned.
    

Intervention name(s): blood donation
Intervention type(s): Procedure
Intervention description(s): phlebotomy until iron depleted
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; nafld; nash; phlebotomy
Abdominal Binder Following Cesarean Delivery
Condition: Cesarean Section Complications
Study type: Interventional

Summary: 
      Cesarean delivery is a common obstetrical procedure and is associated with increased maternal
      morbidity and mortality. Pain and limited mobilization are major contributing factors that
      result in delayed functional recovery and complications. Elastic abdominal binder, a wide
      elastic belt that is wore around the patient's abdomen to support surgical incision after
      surgery, has been employed by clinicians for pain relief, wound complications prevention,
      improved pulmonary function, and stabilization. Benefits of the abdominal binder use have not
      been properly examined.

      The aim of this study is to examine the effect of postcesarean elastic abdominal binder use
      on recovery by comparing pain scores and mobility function (through the 6-minute walk test
      [6MWT]) in postcesarean mothers who use versus do not use the elastic abdominal binder to
      support incisional site.
    


Intervention name(s): Elastic abdominal binder
Intervention type(s): Device
Intervention description(s): Participants will be fitted with an elastic abdominal binder at the time of procedure completion just before leaving the operating room. The binder will be placed snuggly tight on top of the hospital gown at the infraumbilical level with the incision positioned at the middle part of the binder. The patients will be encouraged to wear binders at all time. However, periods of break from wearing the binder will be allowed at their convenience.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
A Study Evaluating the Relative Bioavailability of Lofexidine Granules for Reconstitution Compared to LUCEMYRA (Lofexidine) Tablets and the Effect of Food on the Bioavailability of the Lofexidine Granules for Reconstitution
Condition: Normal Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this open-label, single-dose, randomized, three-treatment, three-period,
      four-sequence, crossover study is to evaluate the relative bioavailability of a test
      formulation of lofexidine granules for reconstitution (oral) and LUCEMYRA tablets under
      fasted conditions and to evaluate the effect of food on the relative bioavailability of
      lofexidine granules for reconstitution (oral) when administered under fed compared to fasted
      conditions.
    


Intervention name(s): Lofexidine (granules for reconstitution); LUCEMYRA (lofexidine) tablets
Intervention type(s): Drug; Drug
Intervention description(s): All subjects will be administered one 0.36 mg dose of lofexidine granules for reconstitution.; All subjects will be administered one 0.36 mg dose of LUCEMYRA (lofexidine) tablets.
Intervention MeSH terms: Lofexidine; Clonidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Medical Clowning and Patient Experiences in a Children's Hospital
Condition: Day Surgery
Study type: Interventional

Summary: 
      A case-control study is conducted in Helsinki Children's hospital. Altogether 70 children
      aged 4-17 years coming for a minor operative procedure including pre-operative cannula
      insertion will be included. Part of the patients will be exposed to medical clowning
      intervention and the reference group will be treated preoperatively as routinely without
      clowns. Emotions, anxiety levels, pain caused by the cannula insertion of the children will
      be monitored during the day. A survey on the emotions and expectations of the parents will be
      done.
    

Detailed description: 
      This study aims to measure experiences of children and their parents during day-surgery in
      hospital setting.

      A case-control study is conducted in Helsinki Children's hospital. Altogether 70 children
      aged 4-17 years coming for a minor operative procedure including pre-operative cannula
      insertion will be included. Part of the patients will be exposed to medical clowning
      intervention and the reference group will be treated preoperatively as routinely without
      clowns. Emotions, anxiety levels, pain caused by the cannula insertion of the children will
      be monitored during the day. A survey on the emotions and expectations of the parents will be
      done.

      A novel digital survey tool will be used to measure patient experiences before and after the
      insertion of a venous cannula needed for anaesthesia.

      The research questions are as follows:

      How does engagement with a medical clown during pre-operative cannulation impact on children
      and their parents' patient experience? How feasible is a novel data collection tool for
      measuring patient experience and the impact of an intervention on the patient experience of
      families?
    

Intervention name(s): Medical clowning
Intervention type(s): Behavioral
Intervention description(s): Medical clowning
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Children and their parents entering day surgery are pre-operatively exposed to medical clowning (N=38) or normal pre-operative care (N=32)
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: patient experience; medical clowning
Impact of Individualized Music Listening for People With Dementia on Anxiety: A Quasi-experimental Study
Condition: Music Listening
MeSH terms: Dementia
Study type: Interventional

Summary: 
      This pilot study was designed to evaluate the effects of Individualized music listening (IML)
      implemented on older adults with mild cognitive impairment (MCI) and PwD. This
      quasi-experimental study used convenience sampling where thirty-two elderly individuals were
      recruited from five community-based dementia care centers then assigned to experimental (EG,
      n = 16) or control (CG, n = 16) groups according to the self-reports of importance of music
      in their lives and according to their personal wishes. The EG received eight treatments of
      IML (two times per week, 20 minutes per time), while the CG received the usual activities of
      the care centers for four weeks when EG received IML. The anxiety levels of both groups were
      investigated before and after first time IML and after eighth time IML. The researcher
      observed positive and negative behaviors of EG before, during and after each IML per 20
      minutes in each time IML.
    


Intervention name(s): Individualized music listening (IML)
Intervention type(s): Other
Intervention description(s): The earphones were placed on individuals in the experimental group to listen to individualized music for 20 minutes. The Individualized music listening (IML) were performed twice a week for four weeks, for a total of eight times.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: dementia; individualized music listening; anxiety; behavior
Clinical Use of Pathogen Reduced Red Blood Cell Suspension
Condition: Oncologic Disorders; Hematologic Diseases
MeSH terms: Hematologic Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to evaluate the effectiveness and safety of the application of
      pathogen inactivated RBC suspension in children with oncological and hematological diseases.
    

Detailed description: 
      Assumed scope of study:

      The study will include 70 patients: 35 patients to the test group, who will get transfusions
      with pathogen-inactivated red blood cell suspension; 35 patients to the control group, who
      will get transfusions with irradiated red blood cell suspension.

      Methods:

        -  Selection of patients suitable to participate in the study.

        -  A few days before the assumed transfusion date, select/prepare a red blood cell
           suspension corresponding to ABO and Rh systems, with no more than 14 days of storage.
           Conduct direct antiglobuline test (DAT), indirect antiglobuline test (IAT) and test for
           individual compatibility with the patient's serum.

        -  Before performing transfusion (on the day of transfusion), determine the initial indices
           of the patient (Hb, Hct, Haptoglobin). Determine the red blood cell suspension indices
           (Hb, Hct, extracellular potassium, free hemoglobin, hemolysis percentage).

        -  Perform transfusion. Evaluate the presence and severity of post-transfusion reactions
           and complications.

        -  Measure the patient's Hb, Hct, potassium and haptoglobin levels the next day after the
           transfusion.

        -  Perform DAT 3 to 5 five days after the transfusion.

        -  Perform IAT 2 to 3 weeks after the transfusion.

        -  Evaluate the need for transfusions over the follow-up period (30 days).
    

Intervention name(s): Riboflavin+UV RBC; irradiated RBC
Intervention type(s): Biological; Biological
Intervention description(s): 35 patients who met all inclusion and exclusion criteria received transfusion with RBC suspension from whole blood, treated with riboflavin and ultraviolet pathogen reduction technology; 35 patients who met all inclusion and exclusion criteria received transfusion with irradiated RBC suspension
Intervention MeSH terms: Riboflavin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Patogen inactivation; Pathogen reduction; clinical use; riboflavin+UV; RBC transfusion; whole blood
Inhibition Control of Children and Adolescents With ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      The objectives of this study are to investigate:

        1. the effect of methylphenidate on attention;

        2. the relations between methylphenidate and inhibition control and working memory;

        3. the relations between inhibition control and verbal attention and working memory;

        4. the effect of methylphenidate on the changes of neuropsychological functioning and blood
           pressure.
    

Detailed description: 
      Attention deficit hyperactivity disorder (ADHD), characterized by inattention, hyperactivity
      and impulsivity, is an early onset, highly heritable, clinically heterogeneous, long-term
      impairing disorder with tremendous impact on individuals, families, and societies. It affects
      5-10% of school-aged children worldwide (7.5% in Taiwan). Methylphenidate, a stimulant, is
      effective in treating these patients. Studies in Taiwan show no effect of methylphenidate on
      blood pressure. There are evidences show that the change of blood pressure was associated
      with inhibition of impulsive behaviors. Stop Signal Task(SST) is used to assess the improve
      of inhibition control after methylphenidate response. By using repeated outcome measurements,
      we anticipate that this study will evaluate the improvement of neuropsychological
      performances after medication and determinie the association between medication response and
      neuropsychological functions and vital signs in a Taiwanese sample.
    

Sampling method: Non-Probability Sample
Study population: 
        We will recruit 60 children and adolescents, aged 10 to 18, who are diagnosed with ADHD at
        the Department of Psychiatry, National Taiwan University Hospital.
Effects of Tipranavir (TPV) and Ritonavir (RTV) on the Pharmacokinetic Characteristics of Tenofovir Disoproxil Fumarate in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to characterise the effects of two dose combinations of tipranavir/ritonavir (TPV 500
      mg/RTV 100 mg and TPV 750 mg/RTV 200 mg) administered BID, on the pharmacokinetics of
      tenofovir disoproxil fumarate as well as the effects of tenofovir disoproxil fumarate on the
      pharmacokinetics of tipranavir/ritonavir.
    


Intervention name(s): Tipranavir low dose; Tipranavir high dose; Ritonavir low dose; Ritonavir high dose; Tenofovir disoproxil fumarate
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Ritonavir; Tenofovir; Tipranavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Blood Levels of HTL0016878 From an Oral Capsule and an Oral Solution
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomised, open-label, 3-period, crossover single dose study to assess the
      relative bioavailability of two formulations of HTL0016878: an oral solution of HCl salt form
      (the reference product) and an oral capsule containing citrate salt (the test product); and
      of the effect of food on the pharmacokinetics of the capsule formulation.
    

Detailed description: 
      Fifteen healthy male or female subjects will be enrolled. Each subject will have 3 study
      sessions and receive a single oral dose of 10 mg HTL0016878 on Day 1 of each study session.
      Subjects will receive the HTL0016878.HCl oral solution in the fasted state in 1 session, and
      the HTL0016878.citrate capsule, in the fasted state and after a high-fat meal, respectively,
      in the other 2 sessions. Each subject will be randomised to 1 of 3 treatment sequences (5
      subjects to each sequence). There will be a washout of at least 10 days between doses.
      Subjects will be screened within 35 days before their first dose of HTL0016878. In each study
      session, subjects will be resident on the ward from the day before dosing (Day -1) until
      completion of procedures 72 h after their dose (Day 4). Subjects will return for a follow up
      visit 10-13 days after their final dose of trial medication.
    

Intervention name(s): HTL0016878.HCl Solution 10 mg; HTL0016878.Citrate Capsule 10 mg
Intervention type(s): Drug; Drug
Intervention description(s): Oral solution fasted; Oral capsule fed or fasted
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Relative Bioavailability
Ankle Proprioceptive Training In Patients With Diabetic Peripheral Neuropathy
Condition: Diabetic Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional

Summary: 
      Diabetes being a very prevalent condition results in various complications including
      neuropathy, which can impair various functional outcomes in patients including balance. Ankle
      proprioceptive training (APT) is an intervention that is used to tackle this problem. The
      study will compare APT with standard balance training in subjects with diabetic neuropathy.
    

Detailed description: 
      The study will include the diagnosed diabetic subjects with score of 4 or more on Douleur
      neuropathique 4 questionnaire (DN4Q). The subjects will be randomly divided into 2 groups;
      interventional group and control group. Interventional group will receive APT 3 days a week
      for 8 weeks. Balance training exercises will be given to both groups 3 days a week for 8
      weeks. The assessments will be done at baseline, after 4 weeks and after 8 weeks of
      interventions.
    

Intervention name(s): Ankle proprioceptive training (APT); Balance training (BT)
Intervention type(s): Other; Other
Intervention description(s): APT comprise of exercises including towel curls, uni-leg stance on foam with activity, writing alphabets on gym ball with toes, picking marbles with toes.
BT includes tendem walk, side leg raises, sit to stand, side walk, back leg raise; Balance training exercises comprising of side walk, tandem walk, standing on one leg, walking with alternating arm raise up to 90 degrees
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There will be two groups .One is interventional and the other is control group. Interventional group will be taking ankle proprioceptive training and balance training, where control will be having only balance training exercises.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes; Diabetic neuropathy; Balance; Risk of fall; Ankle proprioceptive training
PET-CT in AML for Detection of Extramedullary AML Manifestations
Condition: Newly Diagnosed or Relapsed Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Observational

Summary: 
      Myeloid Sarcoma (or granulocytic Sarcoma or Chloroma) is well defined by the WHO. However,
      there are currently no data about the prevalence, sites of occurence and thr prognostic value
      for patients with AML with this finding. Information about this condition is based on
      retrospective analyses since there have been no studies trying to define the role of myeloid
      sarcoma in AML so far. This observational trial will include adult patients with newly
      diagnosed and relapsed AML in order to perform 18FDG-PET-CT imaging prior to induction
      chemotherapy. Furthermore, a second 18FDG-PET-CT will be performed after induction
      chemotherapy to define the responsiveness of these tumors to chemotherapy. The primary
      endpoint of this study is the prevalence of 18FDG-PET-CT positive extramedullary AML
      manifestations (myeloid sarcoma) in patients with newly diagnosed or relapsed AML.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Inpatients or Outpatients with newly diagnosed or relapsed AML AML
      
Keywords: Acute myeloid Leukemia; Myeloid Sarcoma; Extramedullary Acute myeloid Leukemia; 18FDG-PET-CT