bioihbjkbjnl/mcl2 huggingface dataset:
Pre-operative Hypnosis to Prevent Side Effects After Surgery
Condition: Breast Cancer Surgery
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The aim of the pilot study is to translate and feasibility test a brief hypnosis intervention
      in 8-10 patients that are about to undergo thoracic surgery and in 4-5 patients about to
      undergo breast cancer surgery.
    

Detailed description: 
      The hypnosis intervention will be based on a protocol from Montgomery et al. They showed in a
      recent study that a brief 15-minute hypnosis intervention was effective in reducing a number
      of common side effects, including pain, fatigue and nausea. The scripted session includes a
      relaxation-based induction, suggestions for pleasant visual imagery, suggestions to
      experience relaxation and peace, and specific symptom-focused suggestions. The intervention
      will be professionally translated into Norwegian, and adapted and modified as necessary to
      the specific context of this study. The PI, who is a an experienced clinical psychologist,
      will hold the session in the pilot study. Patients will further be instructed to use hypnosis
      on their own following the intervention session.

      The patients will further be invited to participate in semi-structured interviews upon
      completion of the intervention, either by phone or in person, to discuss their experiences
      with the intervention, and share any advice for modifications or changes to the interventions
      or procedures. Systematic text condensation will be applied in the analyses of the
      interviews.
    

Intervention name(s): Hypnosis
Intervention type(s): Behavioral
Intervention description(s): See previous description
Intervention model: Single Group Assignment
Intervention model description: Pilot testing of a pre-operative hypnosis intervention.
Masking: None (Open Label)
Primary purpose: Prevention
Efficacy of a Computerized Cognitive Behavioral Treatment for Insomnia: Increasing Access to Insomnia Treatment to Decrease Suicide Risk
Condition: Insomnia; Physical Health Functioning; Mental Health Functioning
MeSH terms: Sleep Initiation and Maintenance Disorders; Suicide
Study type: Interventional

Summary: 
      Insomnia is major problem among Operation Enduring Freedom (OEF), Operation Iraqi Freedom
      (OIF), and Operation New Dawn (OND) Veterans. Insomnia impacts physical and mental health
      functioning and is associated with reduced quality of life. Cognitive Behavioral Therapy for
      Insomnia (CBT-I) is one of the most promising treatments for insomnia; however, access to
      CBT-I is severely limited by a lack of trained clinicians within the Veterans Health
      Administration (VHA) and Department of Defense (DoD). There is a critical need to offer
      innovative approaches to meet the demand and need for insomnia treatment. Leveraging
      technology to meet treatment demands is consistent with service delivery models based upon
      stepped care principles. This randomized controlled trial will determine whether a
      computerized, self-guided, web-based version of CBT-I is efficacious in reducing insomnia
      symptoms and improving functioning compared to a computerized program control.
    


Intervention name(s): Computerized Cognitive Behavioral Therapy for Insomnia; Sleep Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A computerized insomnia intervention that employs the same behavioral, educational, and cognitive treatment components that underlie non-computerized CBT-I.; A web-based program will deliver components of sleep education via an Internet platform.
Other intervention name(s): cCBT-I
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CBT-I; Insomnia
Repetitive Arm Training + FES on Upper Extremity Motor Recovery in Sub-acute Stroke Survivors
Condition: Stroke; Arm Motor Recovery
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Rehabilitation restores functions and reduces disabilities due to diseases sequelae. The
      relationship between intensity of rehabilitation and clinical outcomes, recently emphasized,
      has generated a great interest for technological high-intensity interventions. However, their
      effects compared to traditional interventions as well the involved biological mechanisms
      remain uncertain. The present Strategic Program aims to predict the treatment efficacy in
      specific rehabilitation profiles, to improve the use of "targeted" therapies and the
      individual management of patients affected by stroke and to transfer these findings into
      rehabilitative strategies.
    

Detailed description: 
      Primary endpoint: Fugl-Meyer Upper Extremity (FM-UE) Secondary endpoints: Box and Block Test
      (BBT), Modified Ashworth Scale (MAS); motor cortex excitability (TMS); Electromyography
      analysis of muscle activation patterns during upper extremity movements; measurements of
      cerebral perfusion (NIRS); circulating biomarkers (see Figure 3 and Table 1). Overall
      assessments will be performed pre-, mid-, post-treatment and at 6-months follow-up.
    

Intervention name(s): conventional therapy; arm training combined with FES
Intervention type(s): Other; Device
Intervention description(s): The conventional rehabilitation program will consist of physiotherapy sessions (100 min/day) following an individualized approach. The program aims at the restoration of mobility and daily living competence. Specific exercises for the affected upper limb will include, bilateral tasks and facilitation techniques.
The amount of treatment will to be comparable between control and experimental groups in order to avoid possible confounding factors.; Arm training protocol Training sessions will last for 60 minutes. The Reo Therapy System is robot-assisted therapy; during the session the subject's affected hand is placed on or strapped onto a robotic arm and the subject is instructed to either actively reach predefined reach points, or to be guided while the robotic arm leads the arm towards these reach points.
Functional electrical stimulation protocol Experimental group will receive up to 40 minutes of FES after arm training. The device consists is a stimulator containing 5 electrodes positioned to provide reliable activation of the following muscles: extensor digitatum communis and extensor pollices brevis, flexor pollices longus, flexor digitatum superficialis, and thenar muscles.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Stroke; Rehabilitation; Arm motor recovery; biological biomarkers
Aesthetic Performance of an Injective Treatment for the Skin Roughness and Laxity of Inner Arm and Abdomen
Condition: Skin Flaccidity and Roughness of the Abdomen and Inner Arms
Study type: Interventional

Summary: 
      The objective of this study was to investigate the aesthetic performance of the Hyaluronic
      acid (HA)-based dermal filler Profhilo® injected by a novel bio aesthetic point technique
      ("BAP" technique) in woman aged 40-65 years with mild-moderate skin flaccidity and roughness
      of the abdomen and inner arms.
    


Intervention name(s): Profhilo®
Intervention type(s): Device
Intervention description(s): Profhilo® (IBSA Farmaceutici Italia S.r.l.) is a resorbable medical device 2.25 ml non-pyrogenic pre-filled syringe, containing 2 ml of 3.2% hyaluronic acid for intradermal use (32 mg H-HA + 32 mg L-HA dissolved in 2 ml of saline buffered sodium chloride.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Darapladib China PK
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate pharmacokinetics (PK), pharmacodynamics (PD) and safety of 160 mg
      enteric-coated micronised free base darapladib in healthy Chinese subjects.
    

Detailed description: 
      SB-480848 (darapladib) is a novel selective and orally active inhibitor of
      lipoprotein-associated phospholipase A2 (Lp-PLA2) being developed by GlaxoSmithKline (GSK)
      for the treatment of atherosclerosis.

      This will be an open label study where each Subject will participate in 2 study sessions, a
      single dose session and a repeat dose session. All Subjects will receive 160 mg of enteric
      coated micronised free-base darapladib as a single dose and as repeated daily doses for 28
      days.

      The purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD)
      and safety of single and repeat oral dose of darapladib in healthy Chinese Subjects. The
      primary endpoints for safety are: clinical safety data from spontaneous adverse event
      reporting, 12-lead electrocardiogram recording, vital sign measurement, nursing/physician
      observation and clinical laboratory tests. The primary PK parameters of interest are area
      under plasma concentration time curve (AUC) and maximum plasma concentration (Cmax) of
      darapladib, while the secondary PK parameters of interest are: time of occurrence of Cmax
      (Tmax) and apparent terminal phase half-life (t1/2) of darapladib as well as AUC, Cmax, Tmax
      and t1/2 of the metabolite, SB-553253. Finally, the PD endpoint of interest is plasma Lp PLA2
      activity, as expressed in terms of percent inhibition relative to baseline.
    

Intervention name(s): darapladib 160mg
Intervention type(s): Drug
Intervention description(s): drug
Intervention MeSH terms: Darapladib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Darapladib, Safety, Pharmacokinetics, Pharmacodynamics, Healthy Chinese Subjects
Efficacy Study of AGSPT201 Tablet to Treat Gastroesophageal Reflux Disease
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate treatment in Gastroesophageal Reflux Disease (GERD)
      patients (aged 18~75) with endoscopically proven GERD treated with AGSPT201 Tablet.
    

Detailed description: 
      This study is 4,8 weeks, outpatient, multicenter, randomized, double-blinded, active drug
      comparative, therapeutic confirmatory clinical study to evaluate the efficacy and safety of
      AGSPT201 in erosive esophagitis patients.
    

Intervention name(s): AGSPT201 Tab contains S-pantoprazole
Intervention type(s): Drug
Intervention description(s): comparison of Pantoloc Tab 40mg
Other intervention name(s): AGSPT201 Tab. (Brand name Deflux tab)
Intervention MeSH terms: Pantoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: GERD; endoscopy; LA grade; heartburn
Proton Pump Inhibitor Versus Histamine-2 Receptor Antagonist for the Prevention of Recurrent Peptic Ulcers
Condition: Peptic Ulcer
MeSH terms: Peptic Ulcer; Ulcer
Study type: Interventional

Summary: 
      Whether pantoprazole versus famotidine for the prevention of recurrent peptic ulcers in
      thienopyridine users remains unclear.
    

Detailed description: 
      The aims of the randomized double-blind comparison study are to compare the efficacy of
      Proton Pump Inhibitor and H2 receptor antagonist for the prevention of recurrent peptic
      ulcers in thienopyridine users. We plan to enroll 334 thienopyridine (clopidogrel or
      ticlopidine) users without baseline gastroduodenal ulcer at initial endoscopy. The patients
      will be randomly assigned to receive either (1) pantoprazole (40 mg qd) or (2) famotidine (40
      mg qd) for 6 months.The ulcer recurrence rate between the treatment groups will be compared.
    

Intervention name(s): histamine-2 receptor antagonist group; proton pump inhibitor group
Intervention type(s): Drug; Drug
Intervention description(s): famotidine tab 40 mg qd for 6 months.; pantoprazole tab 40 mg qd for 6 months.
Other intervention name(s): famotidine 40 mg; pantoprazole 40mg
Intervention MeSH terms: Pantoprazole; Famotidine; Proton Pump Inhibitors; Histamine H2 Antagonists; Histamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: histamine-2 receptor antagonist; proton pump inhibitor; thienopyridine; clopidogrel; prevention
Study of ATI-450 Plus Methotrexate (MTX) vs MTX Alone in Patients With Moderate to Severe RA
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2 study to investigate the safety, tolerability, PK, and PD of ATI-450 plus
      methotrexate versus methotrexate alone in patients with moderate to severe RA.
    

Detailed description: 
      This is a Phase 2, randomized, investigator and patient-blind, sponsor-unblinded, parallel
      group, placebo-controlled study to investigate the safety, tolerability, PK, and PD of
      ATI-450 plus methotrexate versus methotrexate alone in patients with moderate to severe RA
      with inadequate response to methotrexate. All subjects will be required to complete a safety
      follow up visit 30 days post last study medication administration.
    

Intervention name(s): ATI-450; Placebo oral tablet; Methotrexate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral, small molecule MK2 inhibitor; Placebo tablet manufactured to match ATI-450 in appearance; 7.5 mg to 25 mg weekly
Other intervention name(s): CDD-450
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, investigator and patient-blind, sponsor-unblinded, parallel group.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Arthritis; Rheumatoid
Prevalence of Rheumatic Heart Disease Among Pregnant Women in Kenya
Condition: Cardiac Disease; Pregnancy Related
MeSH terms: Rheumatic Heart Disease; Heart Diseases
Study type: Observational

Summary: 
      There is currently no routine screening for cardiac disease for pregnant women in areas of
      high prevalence. This study will aim to determine the point prevalence of cardiac disease in
      women presenting for antenatal care at Moi Teaching and Referral Hospital. More specifically,
      it will aim to use focused echocardiography as a screening tool to determine the prevalence
      of cardiac disease among pregnant women attending MTRH antenatal clinic.
    

Detailed description: 
      Rheumatic heart disease (RHD) in pregnancy can be associated with severe maternal and
      neonatal morbidity and mortality. Early identification of these women and referral to
      specialized, multi-disciplinary care is essential. Overall, studies on RHD prevalence are
      lacking in sub-Saharan countries and a significant gap in the literature exists for the
      prospective assessment of disease in the context of pregnancy. At Moi Teaching and Referral
      Hospital, there are an estimated 3-4 cases per month of women presenting with acute
      exacerbations of either known or newly diagnosed cardiac disease. These women are often the
      most challenging clinically and emotionally for the reproductive health team to manage, and
      contribute to a significant number of the 2-3 maternal deaths per month at MTRH. There is
      currently no routine screening for cardiac disease in the MTRH antenatal clinics. This study
      will aim to determine the point prevalence of cardiac disease in women presenting for
      antenatal care at Moi Teaching and Referral Hospital. More specifically, it will aim to: 1.
      Use focused echocardiography as a screening tool to evaluate cardiac structure and function;
      2. Use focused echocardiography as a screening tool to determine the prevalence of cardiac
      disease among pregnant women attending MTRH antenatal clinic.; 3. Determine the proportion of
      pregnant women with cardiac disease who endorse clinical symptoms as a potential means to
      develop a screening tool; 4. Promote a case-finding culture for cardiac disease in pregnancy
    

Intervention name(s): Focused cardiac echography
Intervention type(s): Diagnostic Test
Intervention description(s): All pregnant women attending antenatal care will be eligible to undergo focused cardiac echo to identify underlying cardiac disease
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        All pregnant women attending the antenatal clinic at Moi Teaching and Referral Hospital.
        This clinic serves approximately 750 women per month. These women draw from urban,
        peri-urban and rural areas. As this is a public hospital, income and education levels are
        low.
Drug Use Study With Intuniv® in Australia
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      This study will evaluate and analyze prescribing behaviors of physicians and determine
      whether Intuniv was correctly prescribed in Australia.
    

Detailed description: 
      This is a drug utilization study using retrospective database analysis where study will
      combine data from two sources of patient-level drug utilization data for Intuniv:

      i) NostraData database: longitudinal participant level prescription database ii) Physician
      survey: de-identified participant data provided by representative physicians in Australia

      In the NostraData database, actual prescription data are collected, which allows generation
      of information on drug usage. However, these prescription data do not contain patient
      variables such as age and indication needed to monitor potential off-label use. Therefore,
      these data must be supplemented with another data source. The physician survey will provide
      the data not included in the NostraData database.
    

Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Participants who have been prescribed Intuniv at least once during the reporting period.
A Double Blinded, Prospective, Randomized, Vehicle Controlled Multi-center Study of Photodynamic Therapy With Visonac® Cream in Patients With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is intended to evaluate the efficacy and safety of Visonac Photodynamic Therapy
      (PDT) in patients with severe acne, score 4 on global IGA scale. The null hypothesis is that
      Visonac PDT is equal to vehicle PDT against the alternative hypothesis that Visonac PDT is
      different compared to vehicle PDT at week 12.
    


Intervention name(s): Visonac PDT; Vehicle cream with PDT
Intervention type(s): Drug; Drug
Intervention description(s): cream application prior to illumination with red light; placebo/vehicle cream application prior to illumination with red light
Other intervention name(s): red light; red light
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acne vulgaris; PDT
Ultrasonographic Parameters in Prediction of Difficult Laryngoscopy in Non-suspected Difficult Airway Patients
Condition: Ultrasound; Difficult Laryngoscopy; Prediction
Study type: Observational

Summary: 
      This study aims to evaluate the ultrasonographic parameters (distance from skin to epiglottis
      (DSE) and distance from skin to vocal cords (DSVC)) as preoperative predictors of difficult
      laryngoscopy in non-suspected difficult airway patients undergoing elective surgery.
    

Detailed description: 
      Airway management is an integral part of general anesthesia. It simply aims to secure the
      patient's airway and achieve adequate ventilation and oxygenation for the patient undergoing
      surgery under general anesthesia. Unsuccessful airway management due to the unexpected
      difficulty in laryngoscopy is a life-threatening situation and may lead to morbidity and
      mortality.

      Many conventional clinical tests are used in preoperative airway assessment such as modified
      Mallampati classification, Thyro-mental distance, inter-incisor distance, cervical mobility,
      and neck circumference, which are used to predict difficulty in the airway, but they have
      limited value and low sensitivity and specificity. Difficult laryngoscopy cannot be always
      predicted based on the preoperative assessment by conventional clinical tests. Some patients
      are thought to have an easy airway by clinical tests, but they show an unexpected difficulty
      in the laryngoscopy.

      The laryngeal view of the patient can be assessed and graded during direct laryngoscopy using
      the Cormack and Lehane grading scale and its modification that describes the laryngoscopy as
      easy or difficult.

      Ultrasonography is a valuable promising tool for preoperative airway evaluation through
      identifying important sonoanatomy of the upper airway such as epiglottis, thyroid cartilage,
      and vocal cords.
    

Intervention name(s): Ultrasound
Intervention type(s): Procedure
Intervention description(s): Ultrasonographic parameters: in the parasagittal plane (1cm from midline) with the patient lying supine, without a pillow, head, and neck in the neutral position, looking straight ahead with mouth closed and the tongue on the floor of the mouth without any movement.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This retrospective observational study will be carried out on 85 patients at Tanta
        University Hospital in the anesthesia department over a period of one year from May 2022 to
        May 2023, which may be extended after approval from the institutional ethical committee of
        the faculty of medicine at Tanta University.

        Laryngeal view grading according to the modified Cormack and Lehane grading scale where
        grades 1 and 2a are considered easy laryngoscopy and grades 2b, 3, and 4 are considered
        difficult laryngoscopy.