bioihbjkbjnl/mcl2 huggingface dataset:
Culturally Adapted Cognitive Behavioral Therapy for Prevention of Self Harm
Condition: Attempted Suicide; Depression
MeSH terms: Depression; Suicide; Self-Injurious Behavior; Suicide, Attempted
Study type: Interventional

Summary: 
      Aim:

      To adapt and develop a culturally appropriate psychological intervention and test its
      feasibility, and acceptability for the patients presenting to general hospital following
      self-harm in Karachi Pakistan.

      Primary hypothesis:

      Patients who receive cognitive behavioral therapy will show significant decrease in suicidal
      ideation as compared to patients with treatment as usual.

      Design:

      Randomized Control Trial

      Setting:

      Medical Departments of General Hospitals in Karachi.

      Participants:

      A total of 200 self harm patients will be randomized to psychological intervention and
      treatment as usual arm.

      Intervention:

      Culturally Adapted Cognitive Behavioral Therapy (CBT)

      Outcome measure:

      Beck Suicidal Ideation Scale
    

Detailed description: 
      Culturally Adapted manualised Cognitive Behavioral Therapy (CBT) will be a brief problem
      focused therapy comprising of 6 sessions within three months after a self-harm episode. The
      adapted therapy/training will be delivered by therapists/trained counselors at the hospital.
      Sessions will be offered weekly in the first two weeks and than fortnightly and will last 50
      minutes. During each session the therapists will assess the risk of suicide and will liaise
      with the research supervisor and patient's treating clinician.

      The areas covered by the manual which has been adapted include an evaluation of the self-harm
      attempt, crisis skills, problem solving, and basic cognitive techniques to manage emotions
      and negative thinking and relapse prevention strategies. The treatment will be structured
      around patient's current problems with the relevant sections of the manual helping the
      patient to deal with specific problems leading to the self-harm act. Between the sessions the
      manual can be used for homework tasks by the patient.
    

Intervention name(s): Other
Intervention type(s): Other
Intervention description(s): No interventions other than the culturally adapted manualised cognitive behavioral therapy
Other intervention name(s): C-MAP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: CBT, self harm, depression, cultural adaptation, Pakistan
Comparison of DuoFertility, LadyComp/BabyComp and Clearblue Monitors
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      Comparative study to determine whether several fertility monitoring products - the
      DuoFertility monitor, the LadyComp/Babycomp monitor and Clearblue Ovulation tests - are
      substantially equivalent in performance, and secondarily to determine the appropriateness of
      labeling information for the DuoFertility monitor.
    

Detailed description: 
      The investigators plan to recruit 30 women who are currently trying to conceive, and ask them
      to use the 3 fertility monitors for duration of 3 menstrual cycles. Additionally, during the
      study the women will be asked to fill in online questionnaires to assess the usability of the
      monitors. As the spouse is often a critical partner in the purchase decision and compliance,
      the investigators will also ask the spouse to complete similar online questionnaires.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Female participants trying to conceive, with regular menstrual cycles.
Study of the Intra-patient Variability of the Quantitative Parameters of Tumor Perfusion Evaluated With Ultrasound Contrast
Condition: GIST Metastatic Cancer; Breast Metastatic Cancer; Kidney Metastatic Cancer; Colon Metastatic Cancer; Rectal Metastatic Cancer
MeSH terms: Neoplasm Metastasis; Neoplasms; Neoplasms, Second Primary
Study type: Interventional

Summary: 
      RECIST criteria for evaluating tumor response are often inadequate for the evaluation of
      anti-angiogenic drugs. An evaluation model of tumor perfusion with contrast-enhanced
      ultrasonography was developed at Gustave Roussy. It assesses the tumor vascular response
      through the analysis of 7 different parameters. Several studies (four at IGR, involving 117
      patients, and a multicenter study involving 400 patients) showed that CEUS allows early
      evaluation of the effect of anti-angiogenic drugs. Two of these parameters are particularly
      interesting for the early identification of patients responding (or not) to treatment. Those
      are area under curve , and area under the wash-out. To further validate the use of these
      parameters, it is essential to measure and describe the level of their intra-patient
      variability.
    


Intervention name(s): CEUS (Contrast-enhanced ultrasound)
Intervention type(s): Device
Intervention description(s): Each patient will be performed 2 contrast echocardiography (a pre-prandial - a post-prandial) before the antiangiogenic treatment, at D15 and D30.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Treatment Of Coronary Bifurcation Lesions: Stentcovering Of The Side Branch With And Without PCI Of The Side Branch: A Retrospective Analysis Of All Consecutive Patients
Condition: Coronary Bifurcation Lesions
Study type: Observational

Summary: 
      This retrospective observational study included patients (pts) with percutaneous coronary
      intervention (PCI) of a de novo coronary bifurcation lesion in one German center between
      January 2008 - August 2011. The investigators included all consecutive patients where the
      side branch was covered with a stent. Patients with ACS/cardiogenic shock were not excluded.

      Two different methods were compared: group A represents patients with a simple strategy
      without any treatment of the side branch (SB). Group B consisted of patients where the SB was
      treated (PCI and/or stenting).

      For the treatment of bifurcation lesions we used the concept of "provisional stenting",
      indications for the treatment of the SB were residual stenosis > 50 %, TIMI flow reduction <
      2. Final-kissing PCI was intended in all patients of group B.

      MACE during follow-up was evaluated in all patients.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        This retrospective observational study included patients (pts) with PCI of a de novo
        coronary bifurcation lesion in one German center between January 2008 - August 2011. We
        included all consecutive patients where the side branch was covered with a stent. Patients
        with ACS/cardiogenic shock were not excluded.
      
Keywords: Coronary intervention; PCI of the side branch
A Study Evaluating the Mass Balance of [14C]HSK3486 Emulsion Injection in Healthy Adults.
Condition: Anesthesia; Sedation
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the mass balance and biotransformation pathways of HSK3486
      in healthy Chinese male subjects administered with a single intravenous dose of [14C]HSK3486,
      so as to characterize the drug's general pharmacokinetics and safety in humans and provide
      supportive data for reasonable use.
    


Intervention name(s): HSK3486
Intervention type(s): Drug
Intervention description(s): The subjects will receive an intravenous injection of 0.8 μCi/0.4 mg/kg of [14C]HSK3486 emulsion injection (i.e., a subject with the body weight of 60 kg is administered with a radiation dose of 48 μCi).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prospective Use of Real-time MRI
Condition: Evaluate the Role of Real-time Imaging in Needle Placement; Evaluate the Workflow and Effectiveness of Realtime Imaging Versus Standard MR Imaging
Study type: Interventional

Summary: 
      This research study is being done to look at a new MRI imaging software, Siemens
      Interventional Software, to see if we can improve our ability to see and treat cancerous
      tumors.
    


Intervention name(s): Real-time imaging for MRI-guided procedures
Intervention type(s): Procedure
Intervention description(s): Real-time imaging for improvement of workflow in MRI-guided procedures
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MRI; real-time imaging; workflow
Improving Adherence to Pharmacological Treatment
Condition: Medication Adherence
Study type: Interventional

Summary: 
      The overall goal of this study was to implement and evaluate the effects of a systems-based
      and pharmacist-mediated program designed to improve adherence for patients with known
      coronary heart disease (CHD) to lipid-lowering pharmacologic therapy and of their
      physicians/nurse practitioners to the National Cholesterol Education Program Guidelines.
    

Detailed description: 
      Patients were randomly assigned to a usual care condition which consisted of patients
      provided with usual care only, or to the Special Intervention (SI) condition. The
      intervention was implemented and coordinated by pharmacists, who utilized for tracking and
      communication the Lotus Notes®-based system that was developed for the project.
    

Intervention name(s): systems-based and pharmacist-mediated program
Intervention type(s): Behavioral
Intervention description(s): Patients in the SI were seen by a study pharmacists prior to discharge to establish a relationship with the patient, explain the pharmacist's role in the study, provide education about all discharge medications and a medication card listing all medications and their manner of use, and set the framework for the follow-up telephone calls. Patients received pharmacist-delivered adherence counseling telephone contacts that took place at two weeks following discharge, and at months 1, 3, 6, and 9 oriented towards assisting patients to remain adherent to prescribed lipid-lowering and other medications, and also towards ensuring that all patients were either documented to be at the LDL-C goal, or were assisted to reach the goal by facilitating the scheduling of repeat lipid measurement as needed and providing information, guidelines and prompts to the patient's physician or nurse practitioner.
Other intervention name(s): Patient-centered counseling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: coronary heart disease; lipid lowering medication; NCEP guidelines
Effect of Ramosetron in Prevention of Intrathecal Morphine Induced Nausea and Vomiting
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 3

Summary: 
      We would like to know the prophylactic anti-emetic effect of ramosetron compare to
      ondansetron in patient undergone total knee arthroplasty with spinal anesthesia and
      intrathecal morphine .
    

Detailed description: 
      The patients were allocated into 2 groups by computerized block randomization according to a
      computer generated randomization. Treatment allocations were contained in sealed envelopes
      that were opened after patient enrollment. Patients received either 8 mg of intravenous (IV)
      ondansetron or 0.3 mg of IV ramosetron 10 minutes before spinal anesthesia and intrathecal
      morphine. All of the unilateral TKAs were done by one orthopedic surgeon using the same
      minimally invasive surgical technique and the same prosthesis.

      Patients were monitored for incidence of Post Operative Nausea Vomiting(PONV) every 6 hours
      until 24 hours, and 24-48 hours postoperatively. Common adverse drug reactions associated
      with serotonin receptor antagonists (pruritus, dizziness, and headache) were also recorded.

      The sample size calculation was based on the ability to detect a difference in incidence of
      postoperative nausea in between the two groups of 40% i.e. 50% in the ondansetron arm, and
      30% in the ramosetron arm, consistent with a previous study. Using a power of 80% (β=0.2) and
      a two sided significance level(alpha) of 0.05, 45 patients in each group were required.
    

Intervention name(s): ramosetron; Ondansetron
Intervention type(s): Drug; Drug
Intervention description(s): intravenous ramosetron 0.3 mg before spinal anesthesia and intrathecal morphine; intravenous ondansetron 8 mg before spinal anesthesia and intrathecal morphine
Other intervention name(s): ramosetorn
Intervention MeSH terms: Ondansetron; Ramosetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Total Knee Arthroplasty; Intrathecal Morphine; Ramosetron; Ondansetron; postoperative nausea and vomiting
Evaluation of the Performance and Safety of a Medical Device Developed to Improve the Reading of Dyslexic Patients
Condition: Dyslexia
MeSH terms: Dyslexia
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the efficacy and safety of a new medical device on the
      improvement of reading skills of dyslexic patients.
    

Detailed description: 
      Dyslexia is defined as a specific learning disability that is characterized by reading
      difficulties, in the absence of intellectual disability, neurological or psychiatric
      disorder, uncorrected sensory disturbance (sight, hearing) or an educational deficiency.

      Dyslexia appears in the child from the earliest stages of learning in the form of a
      difficulty in mastering the learning of reading. This disorder is manifested by a generally
      hesitant reading, slowed down, full of errors, requiring a lot of effort for the child and
      may impact his reading comprehension. The dyslexia-related deficiency is of variable
      intensity depending on the individual; it may be accompanied by calculus disorders
      (dyscalculia), oral language (dysphasia), motor coordination (dyspraxia) or attention
      disorders with or without hyperactivity. In nearly 40% of cases, a child affected by Dys
      disorders presents several learning disorders.

      To date, the causes of dyslexia are not yet clearly established. The wide variety of symptoms
      and disorders associated with dyslexia does not facilitate the identification of precise
      neurobiological / psycho cognitive mechanisms. There are therefore several theories:
      phonological, visual, temporal, cerebellar or proprioceptive auditory processing.

      Recently, following work published in 2017, an anatomical cause based on Maxwell's spots
      could also be a cause of dyslexia.

      The aim of this study is to evaluate a new medical device to compensate this probable
      anatomical cause.
    

Intervention name(s): Scintilling lamp; Classic lamp
Intervention type(s): Device; Device
Intervention description(s): Lamp with a standardized scintilling; Lamp without a scintilling
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dyslexia; Reading disorder
Canadians Achieve Cholesterol Targets Fast With Atorvastatin Stratified Titration
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to assess the effectiveness of an atorvastatin treatment
      regimen involving starting doses between 10 and 80 mg, followed by a single-step titration
      (except for subjects started at 80mg), if required
    


Intervention name(s): atorvastatin
Intervention type(s): Drug
Intervention MeSH terms: Atorvastatin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: (D006937)
Whole Body 111In-exendin-4 Imaging Study in Insulinoma Patients
Condition: Hyperinsulinism; Hypoglycemia; Insulinoma
MeSH terms: Insulinoma; Hypoglycemia; Hyperinsulinism
Study type: Observational

Summary: 
      The purpose of this study is to determine whether the investigators' new imaging modality
      (111In-exendin-4) has advantages in detecting insulinomas in comparison to conventional
      imaging.
    

Detailed description: 
      Insulinomas arise from pancreatic cells and are the most frequent hormone-active tumours of
      the pancreas. Insulinomas produce insulin and can become life threatening if they cannot be
      localised and removed surgically. Complete tumour resection cures most patients, hence
      surgery is the treatment of choice for begin and malignant insulinomas. The potential for
      surgical cure necessitates accurate tumour localisation before surgery because preoperative
      imaging facilitates the detection of small localised, multiple and metastatic insulinomas.
      However, the successful localisation of insulinomas is an challenging problem since
      approximately 30% of insulinomas cannot be visualised radiographically.

      A novel nuclear medicine scanning method using radioactive exendin-4 (111In-exendin-4) has
      recently been developed for imaging of insulinomas. 111In-exendin-4 accumulates specifically
      in insulinoma cells via the glucagon-like peptide-1 (GLP-1) receptor. The accumulation of
      111In-exendin-4 can be visualised by the use of a special camera (Single Photon Emission
      Computed Tomography (SPECT) camera) that detects radioactivity and lights up tumours as hot
      spots.

      The decision to perform surgery is independent of this study. If surgery is performed a small
      sample of the tumor will be used for identifying the sites where 111In-exendin-4 binds to the
      tumor.
    

Intervention name(s): 111In-exendin-4 imaging
Intervention type(s): Other
Intervention description(s): 90-100 megabecquerel (MBq) (30 microgram or less) 111In-exendin-4 IV once
Intervention MeSH terms: Exenatide
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        residents of Switzerland
      
Biospecimen description: 
      Tumor tissue
    
Keywords: Glucagon-like peptide-1 receptor targeting; Insulinoma imaging; Exendin-4; molecular imaging
A Study of LY3832479 (LY-CoV016) in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to learn more about the safety of LY3832479 and any side
      effects that might be associated with it. Blood tests will be done to measure how much
      LY3832479 is in the bloodstream and how long it takes the body to eliminate it. Participation
      could last up to 16 weeks and may include up to 10 visits to the study center.
    


Intervention name(s): LY3832479; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered IV.; Administered IV.
Other intervention name(s): LY-CoV016
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis
Condition: Crohn's Disease; Ulcerative Colitis (Part 2 Only)
MeSH terms: Crohn Disease; Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1 randomized, open-label, multicenter, parallel-group study designed to evaluate
      efficacy, pharmacokinetics and safety between CT-P13 subcutaneous (SC) and CT-P13 intravenous
      (IV) in patients with active Crohn's Disease (CD) and active Ulcerative Colitis (UC).
    

Detailed description: 
      A new subcutaneous infliximab formulation is developed by Celltrion, Inc. as an alternative
      to the intravenous regimen where subcutaneous infliximab injection typically takes less than
      2 minutes. The availability of a subcutaneous formulation of infliximab would increase the
      treatment options available to patients, particularly those wishing to self-administer their
      therapy. This Phase 1 randomized, open-label, multicenter, parallel-group study is designed
      to evaluate efficacy, pharmacokinetics and safety between CT-P13 SC and CT-P13 IV in patients
      with active CD and active UC.
    

Intervention name(s): CT-P13; CT-P13; CT-P13; CT-P13; CT-P13; CT-P13
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): CT-P13 (5 mg/kg) by IV infusion administered as a 2-hour IV infusion per dose every 8 weeks (Part 1); CT-P13 (120 mg) by single SC injection every 2 weeks (Part 1); CT-P13 (180 mg) by double SC 90 mg injections every 2 weeks (Part 1); CT-P13 (240 mg) by double SC 120 mg injections every 2 weeks (Part 1); CT-P13 (120 mg) by single SC injection every 2 weeks in patients with body weight less than 80 kg, and CT-P13 (240 mg) by double SC 120 mg injections in patients with body weight at or above 80 kg based on body weight at Week 6 (Part 2); CT-P13 (5 mg/kg) by IV infusion administered as a 2-hour IV infusion per dose every 8 weeks up to Week 22. From Week 30, CT-P13 (120 mg) by single SC injection every 2 weeks in patients with body weight less than 80 kg, and CT-P13 (240 mg) by double SC 120 mg injections in patients with body weight at or above 80 kg based on body weight at Week 30 (Part 2)
Other intervention name(s): Infliximab; Infliximab; Infliximab; Infliximab; Infliximab; Infliximab
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment