bioihbjkbjnl/mcl2 huggingface dataset:
Sustained Acoustic Medicine Ultrasound Diathermy Clinical Performance
Condition: Measurement of Diathermy on Anatomical Locations of the Body
MeSH terms: Hyperthermia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to measure diathermy performance of Sustained Acoustic Medicine
      Devices with commercially available ultrasound gel coupling patches.
    


Intervention name(s): Sustained Acoustic Medicine
Intervention type(s): Device
Intervention description(s): The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity delivering 18,720 Joules of ultrasound per 4 hour treatment.
Other intervention name(s): SAM; Wearable Ultrasound Device; Long Duration Ultrasound; LITUS Device; Long Duration Low-Intensity Device
Intervention MeSH terms: Oxymetazoline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
To Compare the Safety, Tolerability, and Pharmacokinetics of QBX258 in Patients With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to compare the safety, tolerability, and pharmacokinetics of QBX258
      (sequential administration of a fixed dose of VAK694 and single ascending doses of QAX576) in
      patients with well-controlled mild to moderate asthma.
    


Intervention name(s): VAK694; VAK694 placebo; QAX576; QAX576 placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Intravenous infusion; Intravenous infusion; Intravenous infusion; Intravenous infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Asthma; VAK694; QAX576; QBX258; pharmacokinetics
Acupuncture for Pain Relief During Perineal Repair After Childbirth
Condition: Birth Injuries; Lacerations; Pain
MeSH terms: Birth Injuries; Lacerations
Study type: Interventional

Summary: 
      Midwives and obstetricians are currently using acupuncture for several health problems during
      pregnancy and childbirth. The investigators wish to determine whether acupuncture can be used
      as pain relief during the repair of lacerations in the female pelvic floor following
      childbirth.

      Three acupuncture points in the ear have been reported highly effective for perineal pain
      relief. A scientific trial will compare acupuncture with traditional local anaesthetics when
      midwives conduct perineal repair just after delivery in the hospitals of Southern Denmark.
    

Detailed description: 
      A randomised trial has been initiated. 226 healthy primipara are invited to participate if
      they deliver a child after gestation week 36 and sustain a perineal laceration or an
      episiotomy during childbirth.

      The randomisation is done using a computer-controlled voice response system and the compared
      treatments are:

      A: Acupuncture in Shen Men, GV20, BL36 and 2 needles in the upper ear.

      B: Local anaesthetics (lidocaine 10 ml/mg) directly in the wound area.

      Primary outcomes are:

        1. Need for additional pain relief during the perineal repair.

        2. Pain experienced during perineal repair reported 1 day after delivery.

        3. Wound healing evaluated 1 and 14 days after delivery.

        4. Patient satisfaction with the given pain relief.
    

Intervention name(s): acupuncture in 6 specific points; lidocaine 10mg/ml
Intervention type(s): Procedure; Drug
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Perineal; repair; episiotomies; midwives; pain relief; Episiotomy
Dairy Products With Reduced Sugar and Blood Glucose
Condition: Blood Glucose, High; Metabolic Disease; Overweight and Obesity
MeSH terms: Overweight; Metabolic Diseases
Study type: Interventional

Summary: 
      Dairy products represent an important food group in human nutrition as a source of calcium,
      protein, functional fats and low-glycaemic sugar lactose. While traditionally consumed
      natural milk and yogurt have low sugar content, many flavoured liquid dairy products such as
      chocolate milk, or fermented products such as yogurt have added sugar. Our recent studies
      have shown that the partial reduction of added sugar in chocolate milk and yogurt is not
      associated with any inferior sensory characteristics such as taste and pleasantness compared
      to their full-sugar counterparts. The current project will investigate whether the liquid
      dairy products with reduced sugar content (value-added products) have any benefits on blood
      glucose control in humans.
    


Intervention name(s): Food
Intervention type(s): Other
Intervention description(s): Dairy products with regular and reduced sugar content and water control.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Sugar intake; Sweeteners; Diabetes; Obesity; Sweetened food products; Chocolate milk
Mantel Cell Lymphoma Efficacy of Rituximab Maintenance
Condition: Mantle Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      Randomized, open-label, phase III study to evaluate the efficacy of rituximab maintenance
      therapy in patients aged between 18 and 65 years inclusive undergoing first-line treatment
      for mantle cell lymphoma and exhibiting a response after autologous transplantation.
    

Detailed description: 
      Demonstration of the superiority in terms of 4-year event-free survival (EFS) of Rituximab
      maintenance therapy compared to post-autograft surveillance in patients aged 18-65 years
      inclusive, treated with R-DHAP then autologous transplantation for MCL as first-line therapy.
    

Intervention name(s): Rituximab; Watch and wait
Intervention type(s): Drug; Other
Intervention description(s): 2 months after ASCT maintenance treatment with Rituximab 500mg/m² IV every 2 months during 3 years; No treatment patient follow-up every 2 months during 3 years
Other intervention name(s): Mabthera®; observation
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mantle cell lymphoma; R DHAP; ASCT; Rituximab Maintenance
Evaluate SAGE-547 in Female Participants With Severe Postpartum Depression
Condition: Postpartum Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label proof-of-concept study designed to evaluate the safety, tolerability,
      pharmacokinetics (PK), and efficacy of SAGE-547 Injection in adult female participants
      diagnosed with severe postpartum depression (PPD).
    


Intervention name(s): SAGE-547
Intervention type(s): Drug
Intervention description(s): Intravenous injection
Intervention MeSH terms: Brexanolone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Postpartum depression
TElmisartan and AMlodipine Single Pill sTudy With Patients Not on Goal With Mono rAas Therapy-switch
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The general aim of this trial to determine the efficacy as measured by the percentage of
      patients reaching blood pressure goal at the end of the treatment period at 12 weeks.
      In-clinic blood pressures, home blood pressures and safety will be carefully monitored.
    

Detailed description: 
      Study Design:
    

Intervention name(s): telmisartan/amlodipine
Intervention type(s): Drug
Intervention description(s): start low dose and uptitrate to high dose on the basis of BP goal
Intervention MeSH terms: Amlodipine; Telmisartan; Telmisartan amlodipine combination
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Two Types of Braces in the Treatment of Rockwood Type III AC-dislocations
Condition: Acromioclavicular Joint Dislocation
MeSH terms: Joint Dislocations
Study type: Interventional

Summary: 
      In a randomised prospective comparative Trial the investigators aim to compare the
      conservative Treatment of acromioclavicular dislocations (Rockwood III) with a conventional
      sling versus a Acromion 2.0 brace, which exerts a direct Reposition force on the Joint.

      The sling/brace will be worn for 6 weeks and the patients will be regularly checked
      clinically and radiologically.The investigators are interested in differences of shoulder
      function, Patient satisfaction as well as cosmetic and radiological results.
    


Intervention name(s): Acromion 2.0 Brace
Intervention type(s): Device
Intervention description(s): Acromion 2.0 Brace will be worn for 6 weeks instead of the conventional Mitella sling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Demonstrate the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse
Condition: Anterior Vaginal Wall Prolapse; Vaginal Apex/Uterine Prolapse
MeSH terms: Uterine Prolapse; Prolapse; Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      A prospective, single arm, pre-market, multi-center clinical study to evaluate the safety and
      performance of the SRS (Lyra Medical) vaginal mesh in POP patients
    


Intervention name(s): SRS
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of INCB054707 in Participants With Normal and Impaired Renal Function and Participants on Hemodialysis
Condition: Renal Insufficiency; Kidney Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multi-center, open-label, parallel-group study to evaluate oral doses of INCB054707
      in participants with varying levels of renal function or impairment.
    


Intervention name(s): INCB054707
Intervention type(s): Drug
Intervention description(s): INCB054707 75 mg will be administered orally
Other intervention name(s): Povorcitinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: renal impairment; hemodialysis; Kidney failure; end-stage renal disease
Evaluation of the Role of OCT in the Detection of HIV-associated Neurocognitive Disorder
Condition: AIDS-Related Dementia Complex
MeSH terms: AIDS Dementia Complex; Neurocognitive Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine the sensitivity and specificity of the use of
      optical coherence tomography to detect HIV-associated neurocognitive disorder compared to MRI
      and usual cognitive screening tools.
    


Intervention name(s): Optical Coherence Tomography
Intervention type(s): Other
Intervention description(s): Optical Coherence Tomography provides a non invasive evaluation of the thickness of different layers of the retina
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Optical Coherence Tomography
A Study to Evaluate the Effect of Hepatic Impairment on Lazertinib (JNJ-73841937)
Condition: Hepatic Impairment; Healthy
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of
      lazertinib in participants with impaired hepatic function when compared with healthy
      participants with normal hepatic function, under fed conditions.
    


Intervention name(s): Lazertinib
Intervention type(s): Drug
Intervention description(s): Lazertinib tablet will be administered orally.
Other intervention name(s): JNJ-73841937,; YH25448
Intervention MeSH terms: Lazertinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
STUDY OF ELECTRICAL STIMULATION IN PULMONARY FUNCTION IN INTENSIVE CARE UNIT
Condition: Respiratory Distress Syndrome, Adult
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
Study type: Interventional

Summary: 
      Introduction: The Mechanical Ventilation (MV), a support method used in Intensive Care Units
      (ICU), reaches approximately 90% of critical patients whose withdrawal process represents 40%
      of the total time of their use. For this purpose Transcutaneous electrical diaphragmatic
      stimulation (TEDS), which by means of electrodes placed in motor action points on the phrenic
      nerve tend to provide improvement of the diaphragm muscle function. Objective: To analyze the
      effect of two protocols of transcutaneous electrical diaphragmatic stimulation on the
      ventilatory and cardiorespiratory parameters of critically ill patients. Method: Clinical,
      longitudinal, prospective, quantitative, single center trial will be performed with 30
      (thirty) participants in invasive mechanical ventilatory support, randomly divided into three
      groups: Experimental Group 1 (GE-1; n = 10) where they will be submitted to the TEDS
      protocol; Experimental Group 2 (GE-2; n = 10), where they will be submitted to the TEDS
      protocol based on the studies of Cancelliero et al. (2012); Control Group (GC; n = 10) where
      they will not be submitted to TEDS. All groups will receive physiotherapeutic care from the
      staff of the adult ICU of the FHCGV. The interventions will consist of ten sessions of
      Physical Therapy in each participant in the afternoon shift, for ten consecutive days, 1 time
      a day. For the TEDS procedure, the Orion TENS II (Orion-SP-Brazil) model will be used, the
      Wright analogue respirometer (Spire-SP-Brazil) will be used for the minute volume evaluation
      (V'). The variables of systolic blood pressure (SBP), diastolic blood pressure (DBP), heart
      rate (HR) and peripheral oxygen saturation (SpO2) will also be monitored in order to verify
      if the TEDS application interferes with the hemodynamic variables of these patients. The data
      collected will be linked to Microsoft Office Excel® 2010 software and later transformed into
      tables and graphs. The information collected will be submitted to statistical analysis
      through the statistical package SPSS 22.0, applying the descriptive statistics for the
      characterization of the sample and then selecting the specific tests for the respective
      variances, adopting a level of significance of p≤0.05 for statistical inferences.
    


Intervention name(s): Rehabilitation
Intervention type(s): Other
Intervention description(s): diaphragmatic electrical stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Mechanical Ventilation; Electrical Stimulation; Diaphragm; Ventilometry; Physiotherapy
Preoperative Micronized Flavonoid Fraction (MFF) Use in Multimodal Anesthesia in Anorectal Surgery
Condition: Hemorrhoids; Hemorrhoid Pain; Hemorrhoidal Bleeding
MeSH terms: Hemorrhoids
Study type: Interventional

Summary: 
      Aim: To assess the efficiency of the micro-flavonoid fraction (MMF) administration prior to
      anorectal surgery with spinal anesthesia on postoperative pain severity reduction.

      Methods: Patients who meet the following criteria are included: participants must be
      diagnosed with surgical treatment of anorectal diseases. All participants are randomly
      divided into 2 groups: the first one gets a tablet with 1000 mg MFF (Detralex®), the second
      one gets a tablet containing starch per os 14 days before surgery (72 participants per arm).
      Then patients of each group will continue MFF administration for 30 days after surgery.
      Patients of both arms receive spinal anesthesia and undergo surgery. Following the procedure
      the primary and secondary outcomes are evaluated: frequency of the opioid drugs intake, the
      severity of the postoperative pain syndrome, duration and frequency of other drugs intake,
      readmission rate, overall quality of life, time from the procedure to returning to work and
      the complications rate, C-reactive protein level.

      Discussion: the MFF intake allows reducing the severity of the hemorrhoidal disease symptoms
      during conservative treatment. In addition, the Detralex® efficacy has been proven in
      postoperative pain reduction for patients diagnosed with varicose veins of the lower
      extremities. The investigators intend to evaluate the feasibility of the preoperative MFF
      administration for the postoperative pain reduction and the decrease of the postoperative
      complications in patients with hemorrhoidal disease.
    


Intervention name(s): micronized flavonoid fraction
Intervention type(s): Drug
Intervention description(s): Patients of the experimental group received Detralex® 1000 mg QD for 15 days before the operation, 3000 mg starting from day 1 after the surgery for 4 days, then 2000 mg for the next 3 days and 1000 mg till day 30 after surgery.
Under spinal anesthesia appropriate surgical intervention was performed. After the surgery, the patient was given a questionnaire and a scale for assessing pain at rest and during defecation within the first 2 weeks after surgery. During the hospital stay, the nurse filled out a section on the drugs used; after discharge, the patient filled out this section for 7 days after the surgery. After 30 days, the side effects section was filled out, and the quality of life was assessed on days 7 and 30. Also, the patients indicated in a separate column on which day after the surgery they were able to return to normal living or go to work.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Low Dose IL-2 Therapy in Patients With a Depressive Episode in the Course of a Bipolar Disorder
Condition: Bipolar Depression
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study will be to demonstrate improvement of the T regulatory cells (Treg)
      response, under add on low-dose Interleukin 2 (ld-IL2) in patients with bipolar disorders
      experiencing a depressive relapse
    

Detailed description: 
      A hypothesis still under study concerning the pathophysiological mechanisms of bipolar
      disorder concerns an immunological disorder that could possibly be involved in this disease
      and during a depressive episode. In particular, that the multiplication of a certain category
      of white blood cells called "regulators" that block the toxic effect of more aggressive white
      blood cells could improve these disorders.

      The aim of this research is therefore to check the effectiveness and safety of injections of
      Interleukin 2 (IL-2) to induce this multiplication of regulatory white blood cells.

      IL-2 is a natural protein released by white blood cells that is used for the proper
      functioning of the immune defence system. The favourable effects of injecting small doses of
      IL-2 are known and assessed in other diseases, including autoimmune diseases.

      The secondary objective of this study is to assess the effect of these injections on
      patient's mood, which could be improved by this treatment.
    

Intervention name(s): ILT101; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Treatment administration consists in a first course of five-day treatment (induction), followed by a single injection every week for 4 weeks (maintenance; from Week 3 to Week 6); Treatment administration consists in a first course of five-day treatment (induction), followed by a single injection every week for 4 weeks (maintenance; from Week 3 to Week 6)
Other intervention name(s): IL2; placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled (2 active: 1 placebo), multicentre, 6-week, proof-of concept trial of add on low dose IL-2 therapy in patients with a depressive episode in the course of a bipolar disorder, hospitalized or not. The study will be an add-on study, with no wash-out period.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Low dose of IL-2; Treg response
Comparison of Optical Quality With Different Placement of Refractive Multifocal Intraocular Lens
Condition: Cataract, Age-Related
MeSH terms: Cataract
Study type: Interventional

Summary: 
      The study aims to compare postoperative optical quality between two different implanting
      position of a rotationally asymmetric MIOL [SBL-3 Lenstec; +3.00 diopters (D)], angle kappa
      based implantation and 0 to 180 degree implantation, in order to find out the optimal
      implantation position for SBL-3.
    

Detailed description: 
      SBL-3 has been proved to provide patients with good near, intermediate and distant visual
      acuity, but there is not much study on the impact of SBL-3 position on postoperative visual
      acuity.The regional refractive design of SBL-3 means it could be affected by pupil center
      shift (described by angle kappa: the difference between visual axis and pupil axis), the
      investigators assume that maintaining the ideal ratio of distant and near segment(50% vs 42%)
      in the pupil center could yield both good distant and near postoperative visual acuity
      postoperatively. Therefore, the investigators designed the implantation by placing the IOL
      based on angle kappa to make sure the ratio of distant and near segment exposure in the pupil
      center close to 50:42. In this study, the investigators assessed the optical quality in
      patients with SBL-3 implantation based on angle kappa and 0 to 180 degree to provide surgeons
      with information for choosing appropriate implantation position for optimum postoperative
      satisfaction of SBL-3.
    

Intervention name(s): angle kappa based SBL-3 implantation; 0 to 180 degree SBL-3 implantation
Intervention type(s): Procedure; Procedure
Intervention description(s): SBL-3 implantation based on kappa angle guided by Callisto Eye System(Carl Zeiss Meditec, Germany) intraoperatively.; SBL-3 implantation in the direction of 0 to 180 degree guided by Callisto Eye System(Carl Zeiss Meditec, Germany) intraoperatively.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment. For each patient one eye was randomly selected as design group and receive a SBL-3 implantation based on angle kappa, while the other eye was included in control group and receive a SBL-3implantation of 0 to 180 degree
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Multifocal Intraocular Lenses; visual acuity; kappa angle