bioihbjkbjnl/mcl2 huggingface dataset:
Neurophysiological Examination in Patients With Brain Death
Condition: Brain Death
MeSH terms: Brain Death; Death
Study type: Observational

Summary: 
      This study examines muscle movements of elecromyography in adults with brain death. Half of
      the participants will have brain death, the other half will be healthy volunteers.
    

Detailed description: 
      In some of the patients who have brain death diagnosis, some movements may be seen. Because
      of these movements, the doctors sometimes avoid to make brain death diagnosis. So making
      brain death diagnosis may delay. And in these patients, even if the brain death diagnosis
      made the family members refuse to donate the organs of the patients because they think their
      patients may survive when they see muscle movements with touch. These patients with brain
      death are lost in a short time, so some of the patients can not be used as donors. In this
      study, the investigators aim to raise awareness the movements in brain death patients can be
      seen, to study the movements neurophysiologically by EMG, whether EMG can be used as
      auxiliary method or not in brain death diagnosis and to raise organ donation numbers from
      cadavers. Investigators will examine the motor response and F response in the facial nerve,
      median nerve, and tibialis posterior nerve with electromyography neurophysiologically.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients in the adult intensive care unit
      
Keywords: Brain Death; Spinal Reflex; Electromyography
Management of Depression in Primary Care
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Most people in Sweden with mild to moderate depression are treated in primary care, but
      follow-up is unstructured, and we know little about whether structured, follow-up would
      affect the prognosis for depression and working life. The purpose of this study is to
      determine the effectiveness of regular, structured, patient-centered visits on mild to
      moderate depression.
    


Intervention name(s): Structured patient-centered follow up of depression
Intervention type(s): Behavioral
Intervention description(s): All patients who agree to participate in the study are diagnosed by their GP with a diagnostic assessment instrument called PRIME-MD. Participants in the intervention group visit their GPs at baseline and 4, 8, and 12 weeks. At each visit, participants complete MADRS-s for the assessment of depression severity and discuss the results with their GP in a patient-centered consultation. We have chosen to use the MADRS/MADRS-S depression rating scale in this study because it is a easy to use standard instrument especially suitable for measuring change in depressive symptoms.
The control group receives treatment as usual (no intervention).
Other intervention name(s): MADRS/MADRS-S depression rating scale
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Depression; Intervention; Primary health care
Diagnostic Accuracy of Handheld vs Traditional Ultrasound
Condition: Image, Body
Study type: Interventional

Summary: 
      Patients receiving a point-of-care ultrasound will be randomized into a portable, handheld
      device or a traditional cart-based ultrasound machine to compare diagnostic capability.
    

Detailed description: 
      Patients who require a point-of-care ultrasound examination of their kidneys, gallbladder,
      heart, lung, or aorta will be enrolled. Once enrolled, the patient will be randomized to
      receive the point-of-care ultrasound using a portable, handheld ultrasound or a traditional
      cart based model. The ultrasound examinations will be performed by emergency medicine
      post-graduate year 1-3 residents or an ultrasound fellow and reviewed by the supervising
      emergency medicine attending physicians credentialed in performing and interpreting
      point-of-care ultrasound.

      Based on the clinical presentation, the provider will perform one of the following
      ultrasounds: cardiac to assess ejection fraction ( <50%, 30-50%, <30%), lung to assess for
      presence or absence of B-lines, gallbladder to assess for the presence or absence of
      gallstones, renal to assess for the presence or absence of hydronephrosis, or aorta to assess
      for the presence or absence of an aneurysm. The diagnostic accuracy of the portable, handheld
      and the cart-based model will be assessed using the following as the diagnostic standard:
      cardiology-interpreted echocardiogram, radiology-interpreted ultrasound or computed
      tomography, or quality review of the point-of-care ultrasound by 3 ultrasound fellowship
      trained physicians.
    

Intervention name(s): Portable, handheld point-of-care ultrasound device; Cart-based point-of-care ultrasound device
Intervention type(s): Device; Device
Intervention description(s): The patient will have an ultrasound performed using a handheld, portable device.; The patient will have an ultrasound performed using a traditional cart-based model.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Diagnostic
Study to Assess Adverse Events and Compare How Two Subcutaneous ABBV-154 Injection Formulations Move Through the Body of Adult Healthy Participants
Condition: ABBV-154
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess how safe ABBV-154 is and how ABBV-154 moves through the body of adult
      healthy participants. Adverse Events will be assessed.

      ABBV-154 is an investigational drug being developed for potential treatment of
      immune-mediated inflammatory diseases. Participants are randomly assigned to one of the 2
      treatment groups. Approximately 40 adult healthy volunteers will be enrolled in 2 sites in
      the United States.

      All participants will receive ABBV-154 as subcutaneous injections with one of the 2 different
      formulations.

      There may be higher burden for participants in this trial. Participants will be confined for
      9 days. Adverse Events and blood tests will be performed.
    


Intervention name(s): ABBV-154 Dose Formulation A; ABBV-154 Dose Formulation B
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous Injection; Subcutaneous Injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ABBV-154
Multi-Dose Safety/Pharmacodynamic Study of SEL-212/SEL-037 in Subjects With Symptomatic Gout & Elevated Blood Uric Acid
Condition: Gout Chronic; Hyperuricemia
MeSH terms: Gout; Hyperuricemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open label multicenter study to evaluate the safety and tolerability of multiple
      doses (3 monthly IV infusions) of SEL-212 ( a combination of pegsiticase (SEL-037) and
      SVP-rapamycin (SEL-110)) followed by multiple doses (2 monthly IV infusions) of pegsiticase
      (SEL-037) alone for a total of 5 treatment cycles in subjects with symptomatic gout and
      hyperuricemia. Additional participants will be treated with multiple doses ( 5 monthly IV
      infusions) of pegsiticase (SEL-037) alone.

      Participants will be monitored for safety endpoints through the 5th treatment cycle plus 30
      days .Pharmacokinetic samples will be drawn at pre-determined time points in addition to
      weekly serum uric acid levels.
    

Detailed description: 
      This is an open label multicenter study to evaluate the safety and tolerability of multiple
      doses (3 monthly IV infusions) of SEL-212 ( a combination of pegsiticase ( SEL-037, also
      known as pegadricase) and SVP-rapamycin (SEL-110)) followed by multiple doses (2 monthly IV
      infusions) of pegsiticase (SEL-037) alone for a total of 5 treatment cycles in participants
      with symptomatic gout and hyperuricemia. Additional participants will be treated with
      multiple doses (5 monthly IV infusions) of pegsiticase (SEL-037) alone.

      Uricase is an enzyme that converts uric acid to the readily soluble allantoin that is then
      excreted and SEL-110 is designed to prevent unwanted anti-drug-antibodies (ADAs) from
      forming. All participants will be monitored for safety and tolerability to drug throughout
      the study on a weekly schedule. Pharmacokinetic and pharmacodynamic parameters will at
      specific timepoints to monitor for continued efficacy. Pharmacodynamic parameters measured
      include uric acid levels and levels of ADAs.

      The study duration per enrolled participant will be approximately 6 months including a 1
      month screening period followed by 5 treatment cycles and an end of treatment visit which
      will occur 30 days after the last IV infusion .
    

Intervention name(s): SEL-212; SEL-037; SVP-rapamycin (SEL-110)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SEL-212, biologic; SEL-037, biologic; SVP-rapamycin, biologic
Other intervention name(s): Pegadricase plus SVP-rapamycin; Pegadricase; SEL-110
Intervention MeSH terms: Sirolimus; Temsirolimus; MTOR Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy Participants
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending, Single- and
      Multiple-Oral Dose, Safety, Tolerability, and Pharmacokinetic Study of GDC-3280 in Healthy
      Subjects.
    


Intervention name(s): GDC-3280; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GDC-3280 at various doses, depending on the cohort and treatment period; Placebo at various doses, depending on the cohort and treatment period
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Sustained Acoustic Medicine (SAM) Combined With a Diclofenac Ultrasound Coupling Patch for Knee Osteoarthritis
Condition: Osteo Arthritis Knee; Arthritis
MeSH terms: Arthritis; Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to measure the effectiveness of Sustained Acoustic Medicine
      (SAM) treatment combined with diclofenac ultrasound coupling gel in patients with stage II
      and stage III knee osteoarthritis. The ability of the device to reduce pain, increase
      mobility, increase function of the affected leg, and improve quality of life in patients with
      knee osteoarthritis will be evaluated.
    

Detailed description: 
      This is a seven day study to clinically evaluate the effectiveness of the Sustained Acoustic
      Medicine (SAM) device combined with diclofenac on symptoms of patients suffering from knee
      osteoarthritis. The class-II device, sam® has been FDA-cleared for home use. On the first day
      of the study, baseline data will be collected as patients report pain score before treatment.
      During the following 6 days, patients will self-apply the wearable SAM device with diclofenac
      patch to their affected knee for 4 hours daily. Each day of the study, pain scores will be
      recorded immediately before application of SAM device as well as 30 minutes, 2-hours and
      4-hours after applying the device. A quality of life and function assessment will be
      performed prior to the patient beginning the protocol and at the conclusion of the protocol.

      Up to 32 subjects will be recruited from neighboring communities to the study sites. The
      study is designed to reach a target patient population which includes rural citizens and
      socioeconomic disadvantaged individuals.
    

Intervention name(s): Sustained Acoustic Device with 1% Diclofenac patch
Intervention type(s): Combination Product
Intervention description(s): Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2 with 1% diclofenac patch
Other Names:
ZetrOZ ultrasound device
wearable ultrasound device
long duration ultrasound
LITUS device
long duration low intensity device
Intervention MeSH terms: Diclofenac
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: low-intensity ultrasound; drug delivery; sonophoresis; transdermal drug delivery; Non-Steroidal anti-inflammatory Drugs; sustained acoustic medication; low intensity continuous ultrasound
A Study in Healthy Chinese People to Test How Different Doses of BI 1015550 Are Taken up in the Body
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objectives of this trial are to investigate pharmacokinetics, safety and
      tolerability of BI 1015550 in Chinese healthy male and female subjects following
      administration of single doses.
    


Intervention name(s): BI 1015550
Intervention type(s): Drug
Intervention description(s): BI 1015550
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Retrospective Analysis of the Effects of Red Light Therapy on Body Contouring
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether red light therapy using LED 635nm red light
      for body contouring of the waist, hips and thighs is as effective as red light therapy using
      Laser 635nm red light.
    

Detailed description: 
      Red light laser therapy using 635nm red light laser technology has previously been shown to
      cause lipolysis in subcutaneous fat as a non-surgical method to promote weight loss and body
      contouring. This study hypothesizes that red LED light therapy using 635nm red light LED
      (light emitting diode) technology produces similar results to the laser device (red LASER
      635nm) when performed using a specified treatment protocol.

      Furthermore, it is hypothesized that the UltraSlim Cold Light therapy program achieves the
      results after a single 32-minute treatment. The predicate 635nm laser device (Zerona by
      Erchonia) achieves its results after six treatments combined with a diet and exercise
      regimen.

      UltraSlim Cold Light® is a patented process using the Photonica Professional device for fat
      removal using LED red light therapy. This multi-site study reviews results from 58 randomly
      selected patients after a single treatment using the Photonica Professional device (i.e.
      UltraSlim Cold Light®).
    

Intervention name(s): Ward Photonics Photonica Professional
Intervention type(s): Device
Intervention description(s): Active Device: Ward Photonics, Photonica Professional Red light therapy system
UltraSlim Cold Light® is the name of a patented treatment regimen using the Photonica Professional device for fat removal using LED red light therapy.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Liraglutide Versus Placebo When Added to Basal Insulin Analogues With or Without Metformin in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Asia, Europe and North and South America. The aim of the trial is
      to investigate the effect of liraglutide versus placebo when added to basal insulin analogues
      with or without metformin in subjects with type 2 diabetes.
    


Intervention name(s): liraglutide; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Maximum 1.8 mg administered s.c. (subcutaneously, under the skin) once daily in addition to the subject's stable pre-trial basal insulin analogue regimen plus/minus metformin.; Placebo administered s.c. (subcutaneously, under the skin) once daily in addition to the subject's stable pre-trial basal insulin analogue regimen plus/minus metformin.
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Impacts of Metabolic Variation on Neuroendocrine Control of Reproduction
Condition: Neuroendocrine Reproductive Status
Study type: Interventional

Summary: 
      This study will evaluate the potential effects of a changing metabolic environment on GnRH
      hypothalamic neurons, by performing studies of LH pulsatility (basal and during clamp
      studies) in different groups of male subjects fed isocaloric and hypercaloric diets. The
      participation of other gastro-intestinal tract hormones to these regulations will be
      systematically evaluated.
    


Intervention name(s): effect of metabolic variations on LH pulsatility
Intervention type(s): Dietary Supplement
Intervention description(s): Isocaloric diet: 1,5 times basal metabolism. Constitution:55% carbohydrates, 15% proteins and 30% fat.
Hypercaloric diet: addition of 30% fat and 3 g of fructose/kg of weight to isocaloric diet.
PO and IV glucose during clamps: PO administration of 90 mg/kg glucose at 90 minutes intervals during the clamp, and adjustment of the IV perfusion to keep euglycemia.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: LH pulsatility; GnRH regulation; isocaloric nutrition; hypercaloric nutrition; euglycemic clamps; hyperinsulinemic clamps; testosterone; LH; leptine; ghrelin; PYY; CCK; GLP-1; GIP; cortisol
Follow up Study to Assess Long Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies
Condition: Obstetric Labour, Premature
MeSH terms: Obstetric Labor, Premature
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to assess the safety and outcomes of infants and
      children who were exposed to retosiban or comparator in utero in the Phase III spontaneous
      preterm labor (SPTL) treatment studies, to provide assurance that treatment is not associated
      with significant adverse outcomes in early childhood. The enrolled infants and children will
      be followed at pre-specified intervals until they reach 24 months chronological age. This
      study does not require medical interventions or study visits to an investigational site,
      instead, parents or legal guardians will be prompted at certain time points to complete
      developmental questionnaires and other data on their children's health status via an
      electronic device. Data collected during the infant and child follow up study will be managed
      by a centralized research coordinating center (RCC). Regionally based pediatricians will
      serve as study principal investigators (referred to as RCC-PIs) for this study. All
      communications the RCC-PI has with the parent/legal guardian or the child's health care
      provider (HCP) will occur remotely; there will be no clinic visits.
    


Intervention name(s): Retosiban; Atosiban; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): This is a safety follow-up study of infants and children exposed to retosiban during their mother's participation in a Phase III treatment study for SPTL. Infants enrolled in this study will not be administered any investigational product.; This is a safety follow-up study of infants and children exposed to atosiban comparator during their mother's participation in a Phase III treatment study for SPTL. Infants enrolled in this study will not be administered any investigational product.; This is a safety follow-up study of infants and children exposed to matching placebo for retosiban/ atosiban during their mother's participation in a Phase III treatment study for SPTL. Infants enrolled in this study will not be administered any investigational product
Intervention MeSH terms: Atosiban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: infants; retosiban; Preterm Labor; long-term safety follow-up
Comparing Suprainguinal Fascia Iliaca Block With Erector Spinae Plane Block in Hip and Proximal Femur Surgery
Condition: Postoperative Pain; Femur Fracture; Regional Anesthesia
MeSH terms: Pain, Postoperative; Femoral Fractures
Study type: Observational [Patient Registry]

Summary: 
      Most hip fractures occur in the elderly population. Opioid-related respiratory depression is
      more common in the elderly population but can cause severe brain damage or death. Reducing
      the amount of opioids administered before, during and after surgery by adding a regional
      block may increase the postoperative quality of recovery, reduce chronic pain syndromes, and
      may potentially facilitate the participation of patients in rehabilitation.

      Despite their potential advantages, peripheral nerve blocks are still not widely used in
      people with hip fractures.

      The primary objective of this study is to compare patients' postoperative pain scores and
      opioid consumption.
    


Intervention name(s): Regional Block Comparison
Intervention type(s): Procedure
Intervention description(s): Comparing postoperative pain and opioid consumption in groups
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients over 18 years old, undergoing hip fracture surgery in our university hospital
      
Keywords: Postoperative Pain; Lumbar Erector Spinae Plane Block; Fascia Iliaca Block
Compliance and Usability Study Evaluating RHINIX™ Nasal Filters
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional

Summary: 
      This study will investigate usability and compliance related to rhinix nasal filters for the
      treatment of seasonal allergic rhinitis (hay fever) during the natural grass pollen season in
      Denmark.
    


Intervention name(s): Rhinix Nasal Filters
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment