bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Brain and Renal Regional Oxygenation Using NIRS in Preterm Infants
Condition: Pre-Term; Persistent Ductus Arteriosus
MeSH terms: Ductus Arteriosus, Patent
Study type: Observational

Summary: 
      This study evaluates the brain and renal oxygenation using near infrared spectroscopy in
      preterm infants with persistent ductus arteriosus
    

Detailed description: 
      Patent ductus arteriosus (PDA) is common in preterm infants. In the presence of a large PDA,
      significant systemic to pulmonary shunting occurs, which may result in pulmonary
      hyperperfusion and systemic hypoperfusion.

      The evidence on PDA effect on brain and renal tissue oxygenation, measured by Near Infrared
      Spectroscopy is still controversial.

      This study aims to evaluate the brain and renal oxygenation using near infrared spectroscopy
      (NONIN SenSmart model X-100) in 3 groups of preterm infants: 1) closed ductus arteriosus, 2)
      persistent ductus arteriosus, 3) hemodynamicaly significant ductus arteriosus.
    

Intervention name(s): NONIN SenSmart model X-100 near- infrared spectrometer
Intervention type(s): Device
Intervention description(s): for to measure cerebral (cSO2) and renal (rSO2 ) regional tissue oxygen saturation on the day after echocardiography was done. The sensors were placed on the right/left forehead and the right/left lateral posterior flank
Other intervention name(s): GE LOGIQ S8 XDclear 2.0 ultrasoud
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Preterm infants with gestation age of < 32 weeks, birth weight < 1500g, > 72 hours of age,
        will have NIRS monitors placed to measure cerebral and renal regional tissue oxygenation.
      
Keywords: near-infrared spectroscopy; preterm infant; echocardiography
The Effectiveness and Mechanism Study of Auricular Needling in Treating Cancer Induced Anorexia
Condition: Anorexia Nervosa; Cancer
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Interventional

Summary: 
      Controlling of cancer induced anorexia is highly demanded by advanced cancer patients. It
      plays an important role in improving the quality of life among advanced cancer patients.
      Through a randomized controlled single blinded clinical research, we will observe the
      differences of appetite, food intake amount, weight and KPS between the auricular needling
      treating group and control group before and after the treatment. Based on the results of the
      research, we can prove the clinical effectiveness of auricular needling in treating cancer
      induced anorexia and possible mechanism of the method.
    

Detailed description: 
      Patients will be recruited from Xiyuan Hospital. In this study, eligible participants will be
      randomly assigned to two groups. In the auricular needling treating group, patients will
      receive needling treating for 4 weeks(auricular needles are given to one ear every time for
      2-3days,then switch to the other). Conventional nutrition support and symptomatic treatment
      are given at the same time. In the control group, patient just receive conventional nutrition
      support and symptomatic treatment.

      The simple appetite questionnaire, a symptom based Anorexia assessment questionnaire and
      fatigue symptom inventory questionnaire are used to assess the condition of patients. Other
      observation index include weight, KPS, appetite and the expectation of patients.
    

Intervention name(s): auricular needling
Intervention type(s): Other
Intervention description(s): Patients will be treated with auricular needling for 4 weeks. 4-8 specific auricular acupoints are selected unilaterally at a time, and alternate to another side every 2-3 days, treatment will last for 4 consecutive weeks. The following 4 ear acupoints points will be selected for every patient: Ear Shenmen, Stoma, Spleen, and Subcortex. Other ear acupoints including Triple Energizer, Liver, Sympathetic Nerve and Smallintestine will be selected based on the condition of patients. Treatment will be performed by a registered Chinese medicine practitioner.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Auricular Needling; Mechanism Study; Anorexia; Cancer
AZD6765 Severe Major Depressive Disorder (MDD) IV
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to determine whether AZD6765 has an effect on the
      patient's depression when taken together with current depression medication. In addition,
      information will be gathered on how well AZD6765 is tolerated, investigate the levels of
      AZD6765 and the levels of the current depression medication in the blood. In addition, the
      research staff will determine if AZD6765 has any mood or calming effects (how you feel).
    


Intervention name(s): AZD6765; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): IV once per dosing day, multiple times during the treatment period; 0.9% saline IV once per dosing day multiple times during the treatment period
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Depressive Disorder; MDD
Connectomics in Psychiatric Classification
Condition: Dementia; Dementia Alzheimers; Frontotemporal Dementia; Pick's Disease With Dementia
MeSH terms: Dementia; Alzheimer Disease; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain
Study type: Observational

Summary: 
      Washington University Early Recognition Center is conducting a research study to examine
      brain functional connectivity and network patterns in participants with dementia.
    

Detailed description: 
      This study extends the assessment of brain connectivity and function, being conducted in the
      Human Connectome Project (HCP), to psychiatrically ill populations. The HCP consortium has
      made significant improvements in MRI instrumentation, data acquisition, preprocessing, and
      analysis. These improvements are currently providing publicly available data on the
      structure, function, and connectivity of young adult human (age 22-35) brains at
      unprecedented spatial resolution, temporal resolution, and accuracy. This study will focus on
      individuals aged 45-85 years who have a diagnosis of dementia, or are healthy controls.
      Additionally, similar to the HCP, the investigator will study the effect of genetics on the
      patterns of brain connectivity in various psychiatric populations. DNA will be collected
      non-invasively from saliva. Furthermore, this investigator will study cortisol levels in hair
      samples as an additional assessment to help characterize brain imagining findings.
    

Intervention name(s): MRI Brain Imaging; Mental Health Assessment and Computerized Cognitive Test
Intervention type(s): Device; Behavioral
Intervention description(s): Up to two Magnetic Resonance Imaging (MRI) scan sessions will be done, altogether totaling just under 3 hours of scanning. MR scanners measure brain anatomy and activity using very strong magnets. No X-rays or radiation are involved.; Participants will be asked to complete questionnaires and will be asked questions that address a broad range of personal life experiences involving social, occupational, domestic, and other behaviors.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals between the ages of 45-85 with a diagnosis of Dementia.
Antibiotic Prophylaxis - Amoxicillin
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      The hypothesis of the present study is that quantitative and qualitative oral microflora
      alterations and changes in antibiotic susceptibility among oral commensal microflora will
      occur following a single dose administration of amoxicillin.
    

Detailed description: 
      A total of 33 healthy volunteers, 16 males and 17 females, will be included. Written informed
      consent will be obtained from all participants.

      Subjects will be excluded if they have taken antibiotics within the previous three months,
      are pregnant, breast-feeding or allergic against penicillin.

      The participants will be given a single dose of 2 g amoxicillin. Saliva samples will be
      collected before administration of antibiotics (day 1) and on day 2, 5, 10, 17 and 24.
      Un-stimulated saliva will be accumulated in a plastic container. Concentration of amoxicillin
      in saliva will be measured on day 1, 2 and 5. Samples will be used for the determination of
      antibiotic concentration. Analyses of the sensitivities to amoxicillin and some other
      clinically relevant antibiotic compounds will also be performed.
    

Intervention name(s): Amoxicillin
Intervention type(s): Drug
Intervention description(s): Amoxicillin
Other intervention name(s): Amoxicillin, Sandoz, 1 g tablet
Intervention MeSH terms: Amoxicillin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Antibiotic prophylaxis
Nurses Helping Sudden Cardiac Arrest Survivors Recover After Getting An Implantable Cardioverter Defibrillator (ICD)
Condition: Sudden Cardiac Arrest
MeSH terms: Heart Arrest; Death, Sudden, Cardiac
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine if an education and support nursing intervention program helped sudden cardiac
      arrest survivors adjust to the event and to getting an ICD
    

Detailed description: 
      This study is one of the first large randomized clinical trials of nursing interventions
      aimed at improving health outcomes after receiving an ICD. Written informed consent was used
      in the study.
    

Intervention name(s): Nursing Telephone Support Protocol; Usual Care
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
The Effectiveness of Clavipectoral Fascia Plane Block for Clavicle Surgery
Condition: Clavicle Fracture; Clavicle Injury
Study type: Interventional

Summary: 
      Clavipectoral fascia plane block (CPB). CPB was defined by Valdes in 2017 firstly. It may be
      used for postoperative analgesia after clavicle surgery. In the literature, data about CPB is
      so limited, however it seems a good option for pain management after clavicle fracture.

      The aim of this study is to evaluate the efficacy of the ultrasound-guided CPB for
      postoperative analgesia management and patient satisfaction in patients underwent clavicle
      surgery.
    

Detailed description: 
      Clavipectoral fascia plane block (CPB) was defined by Valdes in 2017 firstly. It may be used
      for postoperative analgesia after clavicle surgery. The clavipectoral fascia covers the
      clavicular site of the pectoralis major muscle. It provides the potential interfascial space
      between the clavicle and the pectoralis major muscle. CPB provide effective analgesia after
      clavicle surgery. It is also easy to perform. With this advantage and its analgesic
      effectiveness for clavicle surgery, CPB may be an alternative to interscalene brachial plexus
      block. However, randomized clinical efficacy trials are needed to investigate the
      effectiveness of CPB for clavicle fractures. In the literature, data about CPB is so limited,
      however it seems a good alternative to brachial plexus block for pain management after
      clavicle fracture
    

Intervention name(s): Clavipectoral block
Intervention type(s): Other
Intervention description(s): Clavipectoral block will be performed with patients in the supine position. The probe will be placed on the anterior border of the medial third (or on the proximal or distal end, according to the localization of the fracture) of the clavicle. A 22-gauge, 50 mm block needle will be inserted in a caudal to cephalic direction, the periosteum of the clavicle and the surrounding fascia will be visualized, 30 ml of 0.25% bupivacaine will be injected between these two layers. The local anesthetic spread to medial and lateral third of the clavicle will be seen.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 38 patients aged 18-65 years old with American Society of Anesthesiologists (ASA) classification I-II and scheduled for clavicle surgery will be included in the study. Patients will be randomly divided into two groups (Group Clavipectoral and Group Control) including 19 patients each, before entering the operating room.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Clavicle surgery; Postoperative pain management; Clavipectoral fascia plane block
Effectiveness of HILT in Shoulder Osteoarthritis
Condition: Osteoarthritis of the Shoulder
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      This study will determine the efficacy of High Intensity Laser Therapy (HILT) for the
      treatment of shoulder osteoarthritis.
    

Detailed description: 
      Shoulder osteoarthritis (SO) is a musculoskeletal joint disease that affects the elderly. SO
      is characterized by degeneration of the articular cartilage in the involved joints and its
      underlying bone within a joint as well as bony overgrowth. It is one of the major causes of
      physical disability that has a social and public health impact due to pain, stiffness, joint
      instability, and muscle weakness.

      The diagnosed patients with SO will be treated with HILT for a total of ten sessions during
      the entire duration of the treatment protocol. Parameters to be evaluated are: range of
      motion, pressure pain (algometer), pain perception (Visual Analog Scale (VAS), Modified
      Laitinen Pain Questionnaire), quality of life (WHOQoL-BREF) These parameters will be recorded
      before the first treatment (baseline), after completion of treatment, three and 12 months
      after completion treatment. A change in above parameters will be evaluated.
    

Intervention name(s): HIRO® 3.0; Sham laser
Intervention type(s): Device; Device
Intervention description(s): Patients will receive pulsed Nd:YAG (yttrium aluminum garnet) laser, produced by HIRO 3.0 device (ASA, Vicenza, Italy). The total energy deliver to the patient during one session will be 3.000 J through three phases of treatment. HILT will be applied for a total of 4 weeks (three sessions/week).; For sham laser, the patient will attended the physical therapy clinic three times a week for 4 weeks and receive sham laser. It is applies the same time than experimental one but with 0 W.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Preoperative Transarterial Chemoembolization for Resectable HCC With Portal Venous Invasion
Condition: Resectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 4

Summary: 
      Whether preoperative transarterial chemoembolization can prolong survival for the resectable
      hepatocellular carcinoma remains controversial, particularly in patients with portal vein
      tumor thrombi. This study designs to systematically identify and summarize the effect of
      preoperative TACE for resectable HCC with portal venous invasion.
    

Detailed description: 
      With various improvements in interventional radiology, since the 2005 practice guidelines
      issued by the American Association for the Study of Liver Diseases , transcatheter arterial
      chemoembolization has become one of the available locoregional therapies for HCC.
      Transcatheter arterial chemoembolization, which generally performed in intermediate-stage HCC
      patients, involves injection of an embolizing agent into the hepatic artery to deprive the
      tumor of its major nutrient source via embolization of the nutrient artery, resulting in
      ischemic necrosis of the tumor. To prevent intrahepatic recurrence due to portal vein
      invasion of the HCC tumor, therapeutic strategies such as preoperative TACE, and
      postoperative adjuvant chemotherapy have been tried. According to the latest and the most
      powerful evidence, however, preoperative TACE is not routinely recommended for patients
      undergoing hepatectomy to treat resectable HCC , and TACE may delay surgical treatment or
      decrease the resection volume of the liver, or it also may create a missed opportunity for
      surgical treatment.

      Rather than subject all these patients to such an invasive procedure and put them at risk for
      missing opportunity for surgical treatment, it may be better to select optimal candidates to
      receive surgical resection. Recent studies have even shown favorable long-term survival
      outcomes of HR in well-selected cases of HCC with PVTT. About whether preoperative
      transarterial chemoembolization is available for the resectable hepatocellular carcinoma with
      portal vein tumor thrombi, so far, has hardly been reported.
    

Intervention name(s): Preoprative TACE; Liver resection plus Thrombectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Liver resection plus Thrombectomy
Other intervention name(s): Preoperative transarterial chemoembolization; Removal of all tumor tissue by surgery
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatocellular Carcinoma; Transarterial Chemoembolization; Hepatic Resection; Portal Vein Tumor Thrombosis
Antibiotic Therapy of Acute Uncomplicated Colonic Diverticulitis
Condition: Colonic Diverticulitis
MeSH terms: Diverticulitis; Diverticulitis, Colonic
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate if antibiotic therapy is necessary for treatment of
      uncomplicated colonic diverticulitis.

      The hypothesis is that Patients with acute uncomplicated colonic diverticulitis will recover
      the condition without antibiotic therapy and the lack of antibiotic therapy will not lead to
      complications.

      The patients will be randomized to conservative treatment with and without antibiotic
      therapy.
    


Intervention name(s): Antibiotic
Intervention type(s): Drug
Intervention description(s): Antibiotic according to local treatment routine against bowel pathogenesis
Intervention MeSH terms: Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: colonic diverticulitis; diverticular disease; antibiotic therapy
The Effects of Sedatives on Tobacco Use Disorder
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This proposal will obtain preliminary data on the effect of a single sub-anesthetic dose of a
      sedative on cigarette craving and smoking behavior as well as measuring tolerability and
      acceptability.
    


Intervention name(s): midazolam intravenous infusion; placebo intravenous infusion; ketamine intravenous infusion
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive a single drug infusion; Participants will receive a single placebo infusion; Participants will receive a single drug infusion
Intervention MeSH terms: Midazolam; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Pharmacokinetics/Pharmacodynamics of NOX-H94 in the Human Endotoxemia Model
Condition: Anemia of Chronic Disease
MeSH terms: Endotoxemia; Chronic Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of the anti-hepcidin Spiegelmer NOX-H94 on
      iron homeostasis during systemic inflammation induced by endotoxin.

      In the human endotoxemia model, intravenously administered lipopolysaccharide elicits an
      inflammatory response with release of pro-inflammatory cytokines, such as IL-6 and TNF-alfa,
      with subsequent induction of hepcidin. As a consequence of hepcidin induction, serum iron
      concentrations decrease.

      This study in healthy subjects investigates the capacity of NOX-H94 to inactivate hepcidin
      and to prevent serum iron decrease in a pathophysiological model prior to studying the
      efficacy of NOX-H94 in patients with anemia of chronic disease.
    


Intervention name(s): NOX-H94; Placebo solution
Intervention type(s): Drug; Drug
Intervention description(s): single i.v. infusion; single i.v. infusion
Other intervention name(s): lexaptepid pegol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Viral Reactivation on Outcomes of Brain-injured Patients ( IBIS-VIRUS)
Condition: Brain Injury
MeSH terms: Brain Injuries
Study type: Observational

Summary: 
      Morbidity and mortality of ICU patients is increased by the development of a
      "immunosuppression" systemic (IS). This IS develops in the early hours of hospitalization and
      is responsible for severe infections, including viral reactivations (Cytomegalovirus or
      Herpes Simplex Virus). Viral reactivation was associated with increased morbidity and
      mortality in intensive care units. In clinical practice, they are searched at the onset of
      organ failure or unexplained fever. The investigators wish to conduct this research in the
      stroke patients to assess the predictive power of these viral reactivations on the duration
      of mechanical ventilation.
    

Detailed description: 
      PCR for herpes simplex virus in blood and in tracheal aspirate (Day-1, Day-7 and Day-15) -
      clinicians are blinded to the results PCR for Cytomegalovirus in blood and in tracheal
      aspirate (Day-1, Day-7 and Day-15) - clinicians are blinded to the results
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        -  Acute brain injury (trauma, subarachnoid haemorrhage, stroke, infection) with Glasgow
             Coma Scale <= 12

          -  Age between 18 and 75 years
      
Keywords: Brain injury; virus; immunosuppression; mechanical ventilation