bioihbjkbjnl/mcl2 huggingface dataset:
Pilot Study of Cognitive Behavioral Therapy for Anxiety and Bipolar I Disorder
Condition: Bipolar Disorder; Anxiety Disorders
MeSH terms: Anxiety Disorders; Bipolar Disorder
Study type: Interventional

Summary: 
      The specific goal of this research study is to investigate the feasibility, acceptability,
      and preliminary efficacy of a transdiagnostic, cognitive-behavioral therapy developed
      specifically to target common core processes across mood and anxiety disorders [Unified
      Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)], for the treatment of
      patients with bipolar I disorder (BD-I) and comorbid anxiety. The study will compare
      treatment-as-usual with pharmacotherapy (TAU) plus 18 one-hour sessions of treatment with the
      UP to TAU alone. Patients in both treatment conditions will be followed over a 12-month
      period and will be assessed monthly to track changes in mood, anxiety and emotion-related
      symptoms; functional impairment; and relapse rates. Data on the acceptability of the
      treatment will be gathered concurrently through monthly patient self-reported ratings of
      treatment satisfaction, and by tracking rates of acceptance for randomization into the study,
      number of completed sessions, and dropout rates. The study will examine: 1) whether combined
      cognitive behavioral treatment (UP) for BD-I and comorbid anxiety disorders is an acceptable
      and feasible approach to treatment; 2) whether treatment with the UP for BD-I and comorbid
      anxiety disorders as an adjunct to pharmacotherapy treatment-as-usual (TAU) leads to greater
      symptom reduction and reduced functional impairment than pharmacotherapy alone, 3) whether
      treatment for BD-I and comorbid anxiety disorders with the UP improves relapse rates over a
      6-month follow-up relative to TAU; and 4) whether reduction in symptoms, relapse rates, and
      functional impairment are mediated by changes in emotion regulation skills. The broader aim
      of this study is to address the need for improved treatments for bipolar disorder.
    


Intervention name(s): UP CBT; Treatment as usual
Intervention type(s): Behavioral; Drug
Intervention description(s): The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders; Existing optimized pharmacotherapy as delivered by treating psychiatrist
Other intervention name(s): Unified Protocol (UP) for transdiagnostic treatment of emotional disorders
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy Study of Combination Therapy With Cetuximab and FOLFOX4 in Patients With Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine confirmed objective response rate to combination
      therapy with cetuximab and FOLFOX4 or FOLFOX4 alone in patients with CRC and non-resectable
      hepatic metastases
    


Intervention name(s): FOLFOX-4+cetuximab; FOLFOX-4
Intervention type(s): Drug; Drug
Intervention description(s): Cetuximab; Weekly administration of Cetuximab IV (initial infusion of 400 mg/m2 for 120 minutes followed by subsequent maintenance doses of 250 mg/m2 for 60 minutes);
FOLFOX-4: Every two week Oxaliplatin; 85 mg/m2 ; day 1 Folinic acid; 200 mg/m2 ; day 1 and 2 5-FU ; Bolus 400 mg/m2 + CI 600 mg/m2 22 h day 1 and 2; FOLFOX-4: Every two week Oxaliplatin; 85 mg/m2 ; day 1 Folinic acid; 200 mg/m2 ; day 1 and 2 5-FU ; Bolus 400 mg/m2 + CI 600 mg/m2 22 h day 1 and 2
Intervention MeSH terms: Leucovorin; Cetuximab; Fluorouracil; Oxaliplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: colorectal cancer; cetuximab; FOLFOX4
Study Evaluating the Safety and Efficacy of ERB-041 on Reduction of Symptoms Associated With Endometriosis in Reproductive-Aged Women
Condition: Dysmenorrhea; Dyspareunia; Endometriosis; Pelvic Pain
MeSH terms: Endometriosis; Dyspareunia; Pelvic Pain; Dysmenorrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the efficacy and safety of two doses of ERB-041 (75
      mg and 150 mg) relative to placebo on the relief of endometriosis-related symptoms
      (dysmenorrhea, pelvic pain, and deep dyspareunia) in reproductive aged women.
    


Intervention name(s): ERB-041
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Endometriosis; Dysmenorrhea; Pelvic pain; Dyspareunia
Diagnostic Strategies in Patients Suspected of Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to determine whether a clinical diagnosis of irritable bowel
      syndrome based on patient reported symptoms and a few blood tests is safe, and to determine
      whether a clinical diagnosis is as good for the patient and as economical for the society as
      a diagnosis based on exclusion of a number of organic diseases by performing a number of
      blood tests, fecal analyzes and a scopic examination of bowel.

      The purpose of the second part of the study is to determine which intestinal parasites the
      patients have in their bowel and whether these parasites are the cause of the disease.
    


Intervention name(s): Exclusion diagnosis; Clinical diagnosis
Intervention type(s): Other; Other
Intervention description(s): Patient fulfill ROME III criteria No Alarmsignals Blood tests: FBC,CRP, ALAT, bilirubins, bas.phosphatases, Albumine, TSH, calcium, celiac screening, lactase gene test.
3 consecutive fecal samples for worm, ovaes and parasites Sigmoidoscopy with biopsy; Patient fulfill ROME III criteria No Alarm signals Blood tests: FBC, CRP.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients are recruited from primary care.
      
Biospecimen description: 
      Blood and fecal sample
    
Keywords: IBS; Diagnosis
Safety, Tolerability, and Pharmacokinetics of IXT-m200
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Approximately 9 participants will be enrolled in the study in a single cohort. Participants
      will be randomized to 3 g IXT-m200 or placebo at 7:2. Each will receive their dose as a
      30-min intravenous infusion, then remain at the study site overnight to complete Day 1 and
      Day 2 assessments (e.g., electrocardiogram (ECG), laboratory assessments, blood draws, and
      vital signs). Following discharge on Day 2, participants will return to the clinic for
      follow-up pharmacokinetic (PK) and safety assessments on Day 8, then every 1-3 weeks
      thereafter until Day 127.
    


Intervention name(s): IXT-m200; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Anti-methamphetamine chimeric monoclonal antibody (mAb); Normal saline
Other intervention name(s): ch-mAb7F9
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Neuronavigation rTMS to Improve Depressive Episodes of Bipolar Disorder in Adolescent
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to explore a new stimulation target and protocol for the
      treatment of depressive episode in adolescents with bipolar disorder through the repetitive
      transcranial magnetic stimulation(rTMS) under neuronavigation, and verify whether there is
      abnormal functional connectivity between the emotion-related brain area orbital frontal lobe
      (OFC) and the primary visual cortex(V1) during the depressive episode, which will contribute
      to further understand the relevant neural pathway and mechanism.
    


Intervention name(s): Repetitive Transcranial magnetic stimulation; Sham Repetitive Transcranial magnetic stimulation
Intervention type(s): Device; Device
Intervention description(s): Setting up a new target for rTMS. In the past research, the common target of rTMS in the treatment of depressive symptom was dorsolateral prefrontal cortex (DLPFC). In this study, we use high frequency rTMS in the occipital lobe are precisely targeted by navigation, by stimulating the primary visual cortex（V1), can affect the orbitofrontal cortex (OFC), which is functionally connected to V1, and thus affect the entire nerve ring pathway excitability, thereby rapidly, effectively and safely improving mood symptoms in the acute phase of bipolar depressive episode.
After the target was determined by fMRI navigation and positioning, the subjects were subjected to rTMS for 20 minutes per day with the stimulation intensity of 10Hz and 100% of the motion threshold(MT),stimulation time of each sequence was 5 seconds, stimulation interval was 15 seconds, 3000 pulses per day for 15 days, and the total number of pulses was 45000.; The stimulus intensity was 20% of MT in the Sham Comparator arm, and the remaining parameters were the same as the Active Comparator arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Motor Imagery and Action Observation on Lumbar Motor Variables
Condition: Motor Activity
Study type: Interventional

Summary: 
      Motor imagery is defined as a dynamic mental process of an action, without its real motor
      execution. Action observation evokes an internal, real-time motor simulation of the movements
      that the observer is perceiving visually. Both MI and AO have been shown to produce a
      neurophysiological activation of the brain areas related to the planning and execution of
      voluntary movement in a similar manner how the real action.
    


Intervention name(s): motor imagery; Action observation; Motor Control Exercises
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): All subjects had to imagine that he/she was performing each exercise during 1 set of 12 repetitions prior to the real execution of this. During the second phase (the second and third week), subjects had to complete the set both imagining, with visual mental motor imagery, and actively performing the exercises.; A video was shown in third-person perspective. All subjects watched one person performing each exercise during 1 set of 12 repetitions. During the second phase (the second and third week), subjects had to perform actively the exercises while they watched the video.; The subjects were asked to perform 3 sets, of 10-12 repetitions each six exercise, with a total duration of approximately 30-35 minutes. The exercises program had to do it once a day, 6 days a week, for 3 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: motor imagery; action observation; motor learning
A Phase I Clinical Study Trial of Felbinac Trometamol Injection in China
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      1. To evaluate the tolerances of healthy subjects treated with Felbinac Trometamol
           Injection on multiple dose and single dose

        2. To evaluate the pharmacokinetic characteristics in healthy subjects treated with
           Felbinac Trometamol Injection on multiple dose and single dose

        3. To provide the basis for the dose for the follow-up clinical study.
    


Intervention name(s): Felbinac Trometamol Injection; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Felbinac Trometamol Injection will be infused IV in 100 mL normal saline,in a 30-minute period using a programmable pump.Three days after the single dose,the drug was given 7 times,3 times/day,once every 8 hours. It means the drug was given 3 times on D3 and D4,once on D5.; Normal saline will be infused IV in 100 mL normal saline,in a 30-minute period using a programmable pump.Three days after the single dose,the Placebo was given 7 times,3 times/day,once every 8 hours.It means the Placebo was given 3 times on D3 and D4,once on D5.
Other intervention name(s): 4-Biphenylacetic Acid; normal saline
Intervention MeSH terms: Biphenylylacetic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tolerance; Pharmacokinetic characteristics
PEACE: Pediatric Antifungal Comparative Effectiveness
Condition: Pediatric Invasive Candidiasis
MeSH terms: Candidiasis; Candidiasis, Invasive
Study type: Observational [Patient Registry]

Summary: 
      The overarching objective is to develop new evidence-based treatment guidelines for invasive
      fungal diseases in children. To accomplish that, this protocol will focus on two specific
      aims: 1) Compare the effectiveness of echinocandin versus amphotericin B or triazole
      antifungal therapy for pediatric invasive candidiasis and for the subset of patients with
      invasive candidemia; 2) Characterize the incidence rate of inpatient pediatric invasive
      candidiasis per hospital admissions.
    

Detailed description: 
      This study is a multicenter, national and international, prospective observational
      comparative effectiveness study.

      The primary aim of this study is to compare the effectiveness of echinocandin versus
      amphotericin B or triazole antifungal therapy for pediatric invasive candidiasis and for
      invasive candidemia. The primary effectiveness endpoint for study aim 1 is the comparison of
      global response at 14 days of antifungal therapy between antifungal therapeutic classes. The
      secondary effectiveness endpoints for study aim 1 are comparative effectiveness of the 1)
      global response to antifungal therapy after 30 days and 2) all-cause mortality at 30 days.

      The secondary aim is to characterize the frequency of pediatric candidiasis by describing the
      incidence of pediatric candidiasis relative to all pediatric admissions. For this aim, the
      investigators will use descriptive statistics to establish the frequency of hospital
      admissions involving an invasive candidiasis per total hospital admissions and total hospital
      days during the study period.
    

Intervention name(s): Observational antifungal therapy
Intervention type(s): Drug
Intervention description(s): Observational study of primary antifungal therapy utilized and outcomes, including:
fluconazole, voriconazole, amphotericin B, caspofungin, and micafungin
All agents are given as standard of care.
Intervention MeSH terms: Antifungal Agents; Clotrimazole; Miconazole
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pediatric patients with invasive candidiasis
      
Keywords: Candida; Pediatric; Antifungal
Videolaryngoscopes for Tracheal Intubation
Condition: Airway Management
Study type: Interventional

Summary: 
      The primary end point of this study is the feasibility of intubation. The secondary
      end-points are the success to intubate in the first attempt, the intubation time, the Cormack
      and Lehane score view, the comparison of the intubation difficulty scale (IDS) score and the
      need for maneuvers to aid the endotracheal intubation comparing Imago V-Blade ® and
      Glidescope®.

      Patients admit to the operation rooms of University of Naples "Federico II" and requiring
      endotracheal intubation for general anesthesia will be consecutively screened for the
      presence of predicted difficult airway according Italian guideline. According to this
      guideline, the presence of one or more of the following parameters may be considered highly
      predictive of difficult intubation: Mallampati class 3-4, inter-incisor distance < 30 mm,
      mental-thyroidal distance < 60 mm, large prominence of superior incisors above inferior
      incisors uncorrectable with jaw-thrust, reduced head and neck motility, and reduced
      mental-jugular distance. Patients matching more then 1 of the previous criteria stated by
      Italian guideline will be included in this case controlled study. Patients 1) without
      criteria for predicted difficult airway; 2) those requiring emergency surgery; 3) aged < 18
      years; or 4) declined consent to participate, will be excluded from this study.The primary
      end-point was the comparison of the intubation difficulty scale (IDS) score. The secondary
      end-points were the learning curve, the intubation time, the Cormack and Lehane score view,
      and the need for maneuvers to aid the endotracheal intubation comparing different
      videolaryngoscopes available in our department. Two anesthesiologists with 10 years of
      experience in conventional endotracheal intubation and trained for video assisted intubation
      will perform the maneuvers.
    


Intervention name(s): Imago V-Balde; Glidescope
Intervention type(s): Device; Device
Intervention description(s): the endotracheal intubation will be performed with videolaryngoscopes (imago V-Blade) according to the user manual; the endotracheal intubation will be performed with videolaryngoscopes (Glidescope) according to the user manual
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Videolaryngoscopes; Intubation
Shoulder Training: Muscle Recruitment Patterns and the Effect of an Exercise Program
Condition: Shoulder Impingement
MeSH terms: Shoulder Impingement Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the muscle recruitment pattern and the effect of
      a 6 week shoulder exercise training program in healthy persons and subjects with shoulder
      impingement
    


Intervention name(s): Exercise training program; Exercise training program
Intervention type(s): Procedure; Procedure
Intervention description(s): A 6 week shoulder exercise training program; A 6 week shoulder exercise training program
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Double J Stenting and Sildosin After URSL for Lower Ureteric Stones
Condition: Lower Ureteric Stones; Ureteroscopic Lithotripsy; DJ Stenting
MeSH terms: Ureteral Calculi; Ureterolithiasis
Study type: Interventional

Summary: 
      The aim of this prospective comparative clinical study to compare DJ stenting and Sildosin
      after ureteroscopic lithotripsy for lower ureteric stones.
    

Detailed description: 
      Ureteric calculi are known to affect approximately 10 - 15% of the overall population. The
      incidence of urolithiasis is rising over time. Most of these stones are known to pass
      spontaneously with or without expulsive medical therapy. The expulsion of calculus depends on
      the following factors: the calculus size and the location in the ureter (Alelign and Petros,
      2018). The calculi expulsion rates change depending on these factors, with the expulsion rate
      ranging from 40% to 98% for calculi less than 5 mm. The calculi, which measure 6 mm or more
      have a spontaneous expulsion rate ranging between 35% to 50%.

      Semirigid ureteroscopy (URS) lithotripsy has been shown to have high success rates for
      treating distal ureteric stones in many studies. However, URS is associated with some
      drawbacks, which may be risky and sometimes problematic.

      The use of Double J (DJ) stent after ureteroscopy helps in the passage of residual fragments
      and prevents pain caused due to mucosal edema and obstruction. However, many patients
      complain of stent-related discomfort in the postoperative period. There is an additional need
      for stent removal, which is another surgical procedure adding to the cost of treatment.
      Despite its usefulness, the morbidity associated with these stents has been considered a
      potential health problem. However, many patients complain of stent-related discomfort in the
      postoperative period. There is an additional need for stent removal, which is another
      surgical procedure adding to the cost of treatment.

      Silodosin is a highly selective alpha-1 adrenergic receptor antagonist which is used in the
      treatment of lower urinary tract symptoms (LUTS). Alpha-1 adrenergic receptors are densely
      found in the smooth muscle cells of the lower urinary tract, and silodosin relaxes them and
      improves the stent-related symptoms (SRS), and various studies have also shown similar
      effects. It has documented its use in the therapy of ureteric calculus.
    

Intervention name(s): DJ stent; Silodosin
Intervention type(s): Procedure; Drug
Intervention description(s): A 5 Fr DJ stent will be inserted and then removed after three weeks.; Patients will be given one capsule of silodosin 8 mg at the night for three weeks.
Intervention MeSH terms: Silodosin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Mutilayered Fresh Amnoitic Membrane Transplantation in Resistant Fungal Keratitis
Condition: Keratitis
MeSH terms: Keratitis
Study type: Interventional

Summary: 
      Corneal infection or infectious keratitis (IK) is the most common cause of corneal blindness
      worldwide, particu-larly in the developing countries1. The incidence was estimated at 2.5-799
      per 100,000 population/year. It is a painful and potentially blinding ocular emergency that
      often requires hospital admission for intensive medical and/or surgical treatment. Depending
      on the geographical and temporal variations and population-based risk factors (e.g.
      agricultural practice, trauma, use of contact lens and others), bacteria and fungi have been
      shown to be the main causative microorganisms for IK, followed by viruses, parasites and
      polymicrobial infection. Amniotic membrane (AM) is the innermost layer of the placenta, which
      consists of a single layer of meta-bolically active epithelium, a thick basement membrane,
      and an avascular stromal matrix (15).

      It has been shown to exhibit a wide array of biological properties, including wound healing,
      anti-inflammatory, antimicrobial, and anti-angiogenic properties, amongst others. To date, a
      number of studies have evaluated the benefit of AMT for treating active IK, though the
      majority of them were of small case series or case reports. In clinical practice, AMT is
      usually reserved as a second-line therapy in IK, mainly to promote cornea healing in
      non-healing ulcer after the sterilization phase.
    


Intervention name(s): Amniotic membrane transplantation
Intervention type(s): Procedure
Intervention description(s): Amniotic membrane (AM) is the innermost layer of the placenta, which consists of a single layer of meta-bolically active epithelium, a thick basement membrane, and an avascular stromal matrix. It has been shown to exhibit a wide array of biological properties, including wound healing, anti-inflammatory, antimicrobial, and anti-angiogenic properties, amongst others. Amniotic membrane transplantation will be performed in eye OT under aseptic conditions. The necrotic tissues at the base of the ulcer will be debrided and sent for culture and sensitivity. The rolledup edge of the ulcer or the loosely adhered epithelium adjacent to the ulcer will also be removed. The amniotic membrane will be trimmed to fit the shape of the ulcer and placed with its epithelial side up. Then the amniotic membrane will be secured with 10-0 nylon suture (5 cases with interrupted and 25 cases with continuous suture) with the suture knots buried.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment