bioihbjkbjnl/mcl2 huggingface dataset:
Stress Reduction for Busy Professionals
Condition: Stress
Study type: Interventional

Summary: 
      This is a pre-post intervention pilot study to evaluate the impact of a 30-minute, 8-week
      mind-body/meditation intervention on self-reported quality of life in individuals employed by
      Allina Health. Outcomes will include validated questionnaires for depressive symptomology,
      perceived stress, anxiety, healthy lifestyle, quality of life as well as biological outcomes
      of salivary cortisol for a sub-sample of employees.
    


Intervention name(s): Meditation
Intervention type(s): Behavioral
Intervention description(s): 30 minute, 8 week meditation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stress; Meditation; Mind body
Safety and Tolerability of Recombinant Humanized Anti-PD-1 Monoclonal Antibody for Patients With Advanced Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a mono-center, open-label, phase 1 study evaluating the humanized anti-PD-1 antibody
      JS001, as a monotherapy in patients with triple negative breast cancer who have failed in
      routine systemic treatment. The study will be conducted in 2 parts: dose escalation and
      cohort expansion to investigate tolerability and efficacy.
    

Detailed description: 
      This is a mono-center, open-label, phase 1 study evaluating the humanized anti-PD-1 antibody
      JS001, as a monotherapy in patients with triple negative breast cancer who have failed in
      previous routine systemic treatment. The study will be conducted in 2 parts: dose escalation
      and cohort expansion. In the first part, nine patients are injected with different dosage of
      the humanized anti-PD-1 antibody (1mg/kg or 3mg/kg or 10mg/mg, three patients in one group )
      once and observed carefully in the following 4 weeks. If no dose-limiting toxicity (DLT)
      occurs, then they are injected every 2 weeks until disease progresses or unacceptable
      toxicity occurs. This part is to confirm DLT, maximum tolerated dose (MTD) and recommended
      dose (RD). In the second part, 6-12 patients are enrolled in each dosage group and injected
      with the humanized anti-PD-1 antibody every 2 weeks until disease progresses or unacceptable
      toxicity occurs. This part is to further analyze safety and efficacy of the humanized
      anti-PD-1 antibody.
    

Intervention name(s): humanized anti-PD-1 monoclonal antibody toripalimab
Intervention type(s): Biological
Intervention description(s): humanized anti-PD-1 monoclonal antibody (JS001) is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activation of lymphocytes and elimination of malignancy theoretically.
Other intervention name(s): JS001, TAB001
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: anti-PD-1 monoclonal antibody; triple negative breast cancer; safety
Comparison of Perioperative Standard Fluid Management and Goal-Directed Fluid Management
Condition: Perioperative Fluid Management
Study type: Interventional

Summary: 
      To compare the goal-directed fluid therapy based on the data obtained from the hemodynamic
      monitoring system, which provides continuous CO, SV and SVV measurements through arterial
      pressure wave with standard fluid therapy in perioperative fluid management of patients
      undergoing head and neck surgery.
    

Detailed description: 
      Following the ethics committee approval and patients consent, the study was completed with a
      total of ASA I-III, 60 patients over the age of 18 who will undergo head and neck
      surgery.After randomization, patients underwent arterial cannulation. The arterial cannulas
      of the study group patients were integrated into the hemodynamic monitoring system with a
      special transducer, and their fluid management was planned to achieve a target value of 13%
      or less through SVV monitoring. In the control group, fluid management was set as MAP (Mean
      arterial pressure) 65 mmHg and above and diuresis 0.5ml/kg/hour and above. Crystalloid
      infusion at 7ml/kg/hour was started in both groups. When SVV value increased to 13% and over
      in the study group, 250 ml of crystalloid was given in the first stage, and if it continued
      to be 13% and over, 250 ml of colloid bolus was given. Vasoconstrictor agent was used when
      SVV was below 13% and MAP was below 65 mmHg. The patients in the control group were given 250
      ml of crystalloid in the first stage if the MAP was below 65 mmHg, and 250 ml of colloid
      bolus if the hypotensive episode continued. If hypotension persisted despite these fluid
      boluses, a vasoconstrictor agent was used. In addition, when the diuresis of the patients was
      detected at 0.5mg/kg/hr or less, 250 ml of colloid bolus was administered.
    

Intervention name(s): Crystalloid solution; Colloid solution
Intervention type(s): Other; Other
Intervention description(s): Crystalloid solution is a true solution and is able to pass through a semipermeable membrane.; Colloid solution is a heterogeneous mixture whose particle size is intermediate between those of a solution and a suspension.
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fluid therapy; prolonged oxygen demand; perioperative fluid balance
Efficiency of Neurostimulation of Tibial Nerve in the Treatment of Low Anterior Resection Syndrome
Condition: Colorectal Surgery
MeSH terms: Low Anterior Resection Syndrome
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the efficiency of the Neuroestimulation of the Posterior
      Tibial Nerve for the treatment of this syndrome.

      A multicentric, prospective, randomized study will be performed in patients affected with
      severe LARS symptoms. Patients will be randomized in two groups:

        1. Control group- placebo

        2. Treatment group: neuroestimulation of the posterior tibial nerve
    


Intervention name(s): Posterior tibial nerve stimulation; Sham posterior tibial nerve stimulation
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Examination of Plasma Concentrations and Safety in Chronic Kidney Disease Patients Undergoing Hemodialysis
Condition: Patients on Stable Chronic Maintenance Dialysis Who Are Receiving Hemodialysis Therapy; Pharmacodynamics of ASP7991; Pharmacokinetics of ASP7991
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics
      of ASP7991 after oral administration to patients with chronic kidney disease undergoing
      hemodialysis.
    

Detailed description: 
      To examine the pharmacokinetics, pharmacodynamics and safety in patients with chronic kidney
      disease undergoing hemodialysis.

        -  To assess the pharmacokinetics (PK), pharmacodynamics (PD), safety and the effect of
           hemodialysis on PK of single oral administration of ASP7991 in Part 1.

        -  To assess the safety, PK and PD of repeated oral administration of ASP7991 in part 2.
    

Intervention name(s): ASP7991
Intervention type(s): Drug
Intervention description(s): oral
Intervention MeSH terms: ASP7991
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: ASP7991; Plasma concentration; Pharmacodynamics; Pharmacokinetics
Study to Evaluate the Incidence, Clinical Characteristics and Economic Burden of Dengue in Brazilian Children
Condition: Dengue
MeSH terms: Dengue; Financial Stress
Study type: Interventional

Summary: 
      The aim of this study is to establish an active surveillance in order to generate dengue
      disease burden estimates including incidence rates, prevalence data, clinical presentation
      and cost of illness in Forteleza (Brazil).
    

Detailed description: 
      Prospective cohort study.

      The study period initially planned to be two years, is extended by one year to cover one
      additional dengue season.
    

Intervention name(s): Data collection; Blood sample collection
Intervention type(s): Other; Procedure
Intervention description(s): Socio-demographic information, medical history, yellow fever vaccination history and dengue suspicion data collection.; A blood sample will be collected at each of the three scheduled study visits and any time during the study that dengue is suspected. Samples collected at scheduled visits will be tested for anti-dengue antibodies. Samples collected at visits for dengue suspicion will be tested for dengue diagnosis.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Brazil; Incidence; Dengue virus; Dengue; Dengue infection
Deep vs Moderate Neuromuscular Blocks on Remifentanil for Laparoscopic Gastrectomy
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      The primary purpose is to compare the remifentanil requirements in deep vs moderate
      neuromuscular blocks during the surgical pleth index -guided anesthesia in patients
      undergoing laparoscopic gastrectomy.
    


Intervention name(s): Neostigmine + glycopyrate; Sugammadex
Intervention type(s): Drug; Drug
Intervention description(s): maintaining of moderate neuromuscular block (train-of-four count 1-2) during surgery, reversal using neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg; maintaining of deep neuromuscular block (posttetanic count 1-2) during surgery, reversal using sugammadex 2-4 mg/kg
Intervention MeSH terms: Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Dexamethasone as Adjuvant to Ropivacaine in Wound Infiltration for Postoperative Analgesia Following Spinal Surgery
Condition: Lumbar Spinal Stenosis; Lumbar Disc Herniation; Lumbar Spondylolisthesis; Lumbar Spine Instability
MeSH terms: Spinal Stenosis; Intervertebral Disc Displacement; Spondylolisthesis
Study type: Interventional
Phase: Phase 4

Summary: 
      Introduction: Improving postoperative pain management after spinal surgery is a significant
      challenge for surgeons and anesthesiologists. Pain following spinal surgery, can lead to
      significant morbidity, limit early mobility, and increase the risk of chronic pain. This
      trial examines the analgesic effects of dexamethasone as an adjuvant to ropivacaine in wound
      infiltration after lumbar surgery.

      Methods: In this study, we randomly assigned sixty patients undergoing lumbar laminectomy
      and/or osteosynthesis into two groups of 30 patients each. The control group (R-group)
      received only Ropivacaine (150 mg of Ropivacaine 7.5% (20 ml) added to 2 ml of normal saline
      in the wound infiltration), while the intervention group (RD-group) received Ropivacaine with
      the addition of dexamethasone (150 mg of Ropivacaine 7.5% (20 ml) added to 8 mg of
      dexamethasone in the wound infiltration). Both groups were administered patient-controlled
      analgesia (PCA) with morphine for self-medication.

      Postoperatively, a blinded evaluator assessed pain at H0, recorded the assessment of surgical
      scar pain using the Visual Analog Scale (VAS) at 4, 6, 12, 24, and 48 hours, as well as the
      time to the first opioid request, cumulative morphine consumption, opioid-related side
      effects, and length of stay. All patients were scheduled for a 3-month follow-up call to
      monitor chronic pain progression.
    


Intervention name(s): Ropivacaine 0.75% Injectable Solution; dexamethasone 8mg
Intervention type(s): Drug; Drug
Intervention description(s): WOUND INFILTRATION AFTER SPINAL SURGERY; WOUND INFILTRATION AFTER SPINAL SURGERY
Other intervention name(s): Alone; with Ropivacaine 0.75% Injectable Solution
Intervention MeSH terms: Dexamethasone; Ropivacaine; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Vitamin D Among Young Adults: an Intervention Study Using a Mobile 'App'.
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      The purpose of this study is to examine whether a behavioural intervention changes attitudes,
      knowledge, intake or blood levels of vitamin D in young adults. The hypothesis is that an
      educational component and use of a mobile smartphone 'app' will increase knowledge and/or
      intake of vitamin D.
    


Intervention name(s): an educational video; wait listed
Intervention type(s): Behavioral; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Vitamin D; Intervention; Behaviour; Mobile app
Greater Occipital Nerve Pulsed Radiofrequency for the Treatment of Combined Migraine and Cervicogenic Headache (New Approach)
Condition: Greater Occipital Nerve; Pulsed Radiofrequency
MeSH terms: Post-Traumatic Headache; Headache
Study type: Interventional

Summary: 
      Combined migraine and cervicogenic headache present significant challenges in clinical
      management due to their complex and overlapping pathophysiologies. Both conditions involve
      the trigeminocervical complex, suggesting a potential shared anatomical and neurobiological
      basis
    

Detailed description: 
      Traditional treatment approaches for these headaches often include pharmacological
      interventions, but in cases of refractory or inadequate response, interventional techniques
      targeting the greater occipital nerve (GON) have gained attention.

      Radiofrequency ablation (RFA) has gained recognition as a potential therapeutic option for
      patients with refractory combined migraine and cervicogenic headaches. The proximal and
      distal ultrasound-guided approaches are widely utilized for GON RFA. These approaches aim to
      disrupt pain signals transmitted by the GON and provide relief of pain for these headache
      disorders
    

Intervention name(s): proximal ultrasound-guided GON radiofrequency ablation; distal ultrasound-guided GON radiofrequency ablation
Intervention type(s): Procedure; Procedure
Intervention description(s): proximal GON radiofrequency; distal GON radiofrequency
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Virological Response Study of the HCV Vaccine IC41
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective is to investigate the virological (HCV-RNA) responses following biweekly
      immunization with IC41.

      Treatment phase 14 weeks, total study duration including follow-up period 38 weeks.
    


Intervention name(s): IC41
Intervention type(s): Biological
Intervention description(s): injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Brain Activation Patterns in Schizophrenia After Computerized Cognitive Skills Training
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      This project is a novel exploratory research project to investigate changes in activation
      patterns of the dorsolateral prefrontal cortex (DLPFC) in inpatients with schizophrenia who
      received a 12-week computerized cognitive remediation (CRT) program. The hypothesis is that
      patients receiving CRT will show greater increase in activation patterns in the brain as
      compared to controls, and the degree of brain activation will correlate with improvements in
      working memory.
    

Detailed description: 
      Abnormalities in the domains of attention, working memory (WM) and information processing are
      important features of schizophrenia. There is growing literature that cognitive remediation
      therapy (CRT) can produce modest improvements in cognitive functioning in schizophrenia,
      suggesting that systematic efforts at improving cognitive functioning are feasible. Cognitive
      improvement after CRT may correlate with changes in brain activation patterns in specific
      areas.

      After screening, patients are randomized to a 12 week trial of CRT using COGPACK (Marker
      Software), or to a 12-week control condition. All patients attend 3 weekly 1-hour laboratory
      sessions, with 1 discussion session per week.

      Patients continue their antipsychotic treatment with a typical or atypical antipsychotic
      during the CRT and 4 weeks prior to enrollment in the study (Phase A). Following Phase A they
      receive baseline evaluations, including an cognitive activation task (N-back visual-letter
      task) while being scanned for fMRI , MATRICS neuropsychological test battery, and
      psychiatric, social functioning, and symptoms assessment.

      Patients then enter Phase B with randomization to control or CRT for 12 weeks (36 laboratory
      sessions). Upon successful completion of 36 sessions, endpoint evaluations include an N-back
      task while fMRI scan, MATRICS, psychiatric, and social functional assessments.

      All baseline and endpoint fMRI scans are conducted at the Center for Advanced Brain Imaging
      (CABI) at Nathan Kline Institute for Psychiatric Research.
    

Intervention name(s): Cognitive remediation therapy
Intervention type(s): Behavioral
Intervention description(s): 36 sessions of computerized cognitive skills training over a 12 week duration. 7 patients were assigned to cognitive remediation therapy or CRT Group.
Other intervention name(s): CRT Group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fMRI; working memory; schizophrenia; treatment refractory; cognitive skills training; dorsolateral prefrontal cortex; cognitive remediation; treatment refractory schizophrenia of > 5 years duration
Protective Variable Ventilation for Open Abdominal Surgery
Condition: Development of Pulmonary Dysfunction Following Open Abdominal Surgery
Study type: Interventional

Summary: 
      Variable ventilation has been shown to improve lung function and reduce lung damage as well
      as inflammation in different models of the acute respiratory distress syndrome. Also,
      variable ventilation is able to recruit lungs. The present study will investigate whether
      variable as compared to non-variable ventilation improves post-operative lung function and
      reduces systemic inflammation in patients submitted to open abdominal surgery.
    


Intervention name(s): Variable Ventilation
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: mechanical ventilation; lung function; abdominal surgery, open; systemic inflammation
Adherence to Antimalarial Drugs in Sierra Leone
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional

Summary: 
      The aim of this study is to address this gap in knowledge by measuring the level of patient
      adherence to co-formulated amodiaquine and artesunate (AQ-AS) compared to
      artemether-lumefantrine (AL) under routine conditions in Sierra Leone and explore the key
      factors that influence adherence. This will be addressed through a mixed methods study that
      will provide not only a measurement of adherence ACTs and malaria test results, but will also
      provide contextual information in order to better understand factors that affect adherence.
      Data will be collected through a series of interviews with health workers and
      parents/caregivers and through observations of patient-provider consultations.

      The first stage of the study begins with semi-structured interviews and observations of
      patients/caretakers' consultations with health workers and will look at how health workers
      diagnose and treat malaria. This will be followed by short exit interviews at the health
      facility with caregivers to assess patient satisfaction with services, as well as to test the
      consistency between the data obtained through structured observations and the exit
      interviews.

      Follow-up surveys at the homes of patients will be used to measure and compare the adherence
      of participants to two different ACTs (AQAS and AL) formulations and potential factors that
      affect adherence. Additionally, data will be collected using in-depth interviews to collect
      supplementary information in order to discover, in more detail, factors that may affect
      behavioral choices and/or attitudes with regard to adherence.
    


Intervention name(s): amodiaquine-artesunate (AQAS) fixed-dose; Artemether-lumefantrine combination (AL) dispersable
Intervention type(s): Drug; Drug
Other intervention name(s): coarsucam, winthrop, co-formulated; coartem, AL, locally all Artemether-lumefantrine called 'lokmal'
Intervention MeSH terms: Artesunate; Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination; Amodiaquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the efficacy and safety of fexofenadine 120mg BID
      compared to placebo in the treatment of subjects with mild to moderate persistent asthma
    

Detailed description: 
      The incidence of respiratory allergy in the US has increased gradually over the past several
      years, and current estimates suggest that allergic rhinitis and bronchial asthma affect
      approximately 20% and 5% of the population, respectively. Rhinitis and asthma frequently
      coexist, and large-scale population surveys indicate that up to 38% of subjects with rhinitis
      have asthma, and up to 78% of subjects with asthma have chronic nasal symptoms. Safety
      concerns with the increased use of inhaled corticosteroids, the heterogeneity of the disease,
      and poor compliance with asthma medication regimens, point to the need for the development of
      safe and convenient oral therapies for asthma. Histamine is an important chemical mediator of
      inflammation in asthma. The benefits of antihistamine treatment in patients with mild to
      moderate asthma have been well documented, however their clinical use has been previously
      limited due to the high doses required for efficacy and their associated side effects
      including sedation and cognitive impairment.
    

Intervention name(s): Fexofenadine
Intervention type(s): Drug
Intervention MeSH terms: Fexofenadine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment