bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate whether prolonged oral levosimendan can preserve respiratory
      function more effectively than placebo, resulting in better patient functionality as measured
      by the ALSFRS-R scale. In this randomized, double-blind, placebo-controlled, parallel-group,
      multicenter study, subjects are allocated in a 2:1 ratio to receive either levosimendan (1 -2
      mg daily) or placebo for 48 weeks. The primary endpoint is slow vital capacity (SVC) at 12
      weeks, with the impact on patient function assessed through 48 weeks, adjusted for patient
      outcome, using ALSFRS-R (combined assessment of function and survival, CAFS). Other important
      efficacy measures include time to respiratory events, clinical global impression (CGI),
      assessment of dyspnea using the Borg scale and sleep scales (Pittsburgh sleep quality index
      and Epworth sleepiness scale). Patient safety is monitored using conventional methods
      including adverse events, safety laboratory tests, vital signs and 12-lead EKG. Following
      screening and baseline visits, patients attend the clinic at 2, 4, 8, 12, 24, 36 and 48
      weeks, with telephone assessments conducted at weeks 18, 30 and 42. An end of study visit is
      performed 14-25 days after the last study treatment administration. The study will be
      monitored by an independent data and safety monitoring board. A long-term extension study
      will be available for patients completing the study.
    


Intervention name(s): Levosimendan; Placebo for levosimendan
Intervention type(s): Drug; Drug
Intervention description(s): Levosimendan 1 mg capsule for oral administration; Placebo capsule for oral administration
Other intervention name(s): ODM-109; Placebo for ODM-109
Intervention MeSH terms: Simendan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Positive Psychology Program in Cardiac Rehabilitation
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome
Study type: Interventional

Summary: 
      Study to try to clarify the role of the dimensions of positive psychology as cardioprotective
      factors, controlling the classic CVR factors, both biomedical and psychosocial, as well as
      develop and test the effectiveness of a program Protocolized Psychological Intervention (PI),
      in a randomized clinical trial.
    

Detailed description: 
      It is intended to develop a collaborative study between Hospital Universitario 12 de October
      and the Faculty of Psychology of the Camilo José Cela University of Madrid to try to clarify
      the role of the dimensions of positive psychology as cardioprotective factors, controlling
      the classic CVR factors, both biomedical and psychosocial, as well as develop and test the
      effectiveness of a Protocolized Psychological Intervention, in a randomized clinical trial
      that will be developed in different phases of the cardiac recovery process in people who have
      had an acute coronary syndrome (ACS). The psychological intervention will include (1) a brief
      early intervention during hospitalization (based on psychoeducation, relaxation techniques,
      behavioral activation and focus on positive attitudes), and (2) during the follow-up phases,
      from two months after the hospital discharge, an intervention that will be made up of
      different packages depending on the individual profile (management of emotions, lifestyle
      healthy, post-traumatic growth and resilience, consolidation of intentions), versus a control
      group that will follow the standard cardiac rehabilitation program.
    

Intervention name(s): Multicomponent Psychological Program (MPP)
Intervention type(s): Behavioral
Intervention description(s): Patients will receive "health pills" during hospital admission. This intervention will be brief for individual application, but without specific content for each person, protocolized in its content and tools, and with a cognitive-behavioral orientation. Its therapeutic objective is to provide the patient with immediate control strategies for negative emotions and some pattern of active and positive coping. Two months after hospital discharge, the patients will also receive a multicomponent psychological program of a group nature. Based on motivational interviewing and positive psychology, with two blocks: emotions and consolidation of intentions. Two individual sessions will be carried out at the beginning to be able to do individual orientation, plan the intervention protocol, determine the objectives, the group intervention, and the specific action packages that the patient will receive.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel group clinical trial, experimental group with psychological intervention versus control group without intervention
Masking: None (Open Label)
Primary purpose: Treatment
F901318 Single Ascending Dose Study in Healthy Male Volunteers
Condition: Invasive Aspergillosis
MeSH terms: Aspergillosis
Study type: Interventional
Phase: Phase 1

Summary: 
      F901318 is a potent new antifungal agent for the treatment of systemic fungal infections.
      This study will test it for the first time in man with the objective of assessing its safety,
      tolerability and pharmacokinetic profile.
    

Detailed description: 
      Double blind, placebo controlled, ascending single intravenous dose, sequential group study.
      Forty subjects will be studied in 5 cohorts (Groups A to E), each group consisting of 8
      subjects. Each subject will be on study for approximately 6 weeks. Each subject will
      participate in one treatment cohort only, residing at the Clinical Research Unit (CRU) from
      Day -1 (the day before dosing) to Day 6 (120 hours post-dose). Each cohort will be dosed in a
      leading edge design in which two subjects will receive study drug (1 active and 1 placebo) on
      the first dosing day, and the last 6 will receive study drug (active or placebo) on the
      second dosing day.

      All subjects will return for a post-study visit 8 to 10 days after the dose of study
      medication.

      Cohorts will be dosed at 2 weekly intervals. There will be a review of safety and
      pharmacokinetic data prior to each dose escalation.
    

Intervention name(s): F901318; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.
Pharmacokinetic profile; Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities
Intervention MeSH terms: Olorofim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: First in man; Antifungal; Intravenous infusion; Healthy volunteers
Trial Assessing the Efficacy of a Short Course of Intravenous Antibiotic Followed by Oral Antibiotic in Uncomplicated Acute Diverticulitis
Condition: Diverticulitis
MeSH terms: Diverticulitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Medical treatment of uncomplicated acute diverticulitis is not standardized and there is an
      enormous diversity in clinical practice. The investigators' aim was to demonstrate that
      uncomplicated diverticulitis can be managed with oral amoxicillin plus clavulanic acid with a
      short hospital admission.
    

Detailed description: 
      A prospective randomized trial was established to compare patients with uncomplicated
      diverticulitis who received oral antibiotic after a short course of intravenous antibiotic,
      with those who received intravenous antibiotic for a longer period. We included 50 patients,
      25 in each group. Patients in group 1 begun oral antibiotic as soon as they improved and were
      discharged the day after. Patients in group 2 received intravenous antibiotic for 7 days.
      Both groups received oral antibiotic at discharge. The endpoint of the study was "failure of
      treatment" which was defined as the impossibility of discharging on the expected day,
      emergency admission or hospital readmission.
    

Intervention name(s): amoxicillin plus clavulanic acid; amoxicillin plus clavulanic acid
Intervention type(s): Drug; Drug
Intervention description(s): intravenous amoxicillin plus clavulanic acid 1 gr every 8 hours 48 hours followed by oral amoxicillin plus clavulanic acid 1 gr every 8 hours for 10 days; intravenous amoxicillin plus clavulanic acid for 7 days followed by oral antibiotic for 5 days
Intervention MeSH terms: Amoxicillin; Clavulanic Acids; Clavulanic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diverticulitis
Postoperative Pain Assessment After Using Different Kinematics
Condition: Root Canal Therapy
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The aim of this study is to evaluate postoperative pain after endodontic instrumentation
      using rotation, reciprocation and adaptive motion.
    

Detailed description: 
      Post operative pain assessment is done at the end of the session Visual Analog Scale (VAS)
      questionnaires were handed out to the patients and they were asked to assign a number
      correlating to their post-treatment pain, with 0 representing no pain and 10 representing the
      most severe pain imaginable.These scores were marked in intervals of 6, 12, 24, 48 and 72 h
      following endodontic treatment.
    

Intervention name(s): Root canal therapy
Intervention type(s): Procedure
Intervention description(s): Different types of instrumentation motions during root canal therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Behavior During Experimentally Induced Pain
Condition: Schizophrenia; Major Depression
MeSH terms: Depression; Schizophrenia; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Numerous factors can influence the processing of pain message: the affective or emotional,
      the sensorial and the cognitive components. Interindividual variations at the emotional and
      cognitive levels may interfere with the pain message and the consecutive behavior. Some
      modifications in these components are observed in psychiatric troubles, but their influences
      on the behavior to pain have not been studied, although they have been studied in some
      populations characterized as non communicating, with obvious cognitive degradations (subject
      with dementia, older, newborns,…).In an other study in course, the past pain experience is
      explored in relation to results to experimental pain tests, emotional and anxious
      characteristics. This present pilot study aims at studying the infra-verbal behavioural signs
      during experimentally induced pain in subjects with schizophrenia, major depression, and
      controls.
    

Detailed description: 
      The objective is to search for behavioral non verbal indicators of pain during experimentally
      induced pain (pressure application, ischemia induction).

      Included subjects are subjected to experimental pain tests : pressure application (160 kPa)
      with an algometer to determine the pain with Visual Analogic Scale (VAS), and ischemia
      induction to determine the time needed to feel pain with an intensity equivalent to 3 with
      the VAS.

      Subjects are filmed during experimentation to identify the corporal mobility signs, facial
      expression signs and sonorous signs associated to pain stimulation.

      Neurophysiological measures complete these observations : surface electromyogram, heart rate
      measure, blood pressure.
    

Intervention name(s): pain tests
Intervention type(s): Other
Intervention description(s): pain induction with pressure application or ischemia on the arm
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: schizophrenia; major depression; pain; behavior
Modular Cognitive Behavioral Therapy for the Treatment of Child Anxiety Disorders in Elementary School Settings
Condition: Separation Anxiety Disorder; Generalized Anxiety Disorder; Social Phobia
MeSH terms: Anxiety Disorders; Phobia, Social; Anxiety, Separation
Study type: Interventional
Phase: Phase 2

Summary: 
      Although cognitive behavioral therapy (CBT) has been found to be efficacious in the treatment
      of child anxiety disorders, little progress has been made in the dissemination of such
      treatments to real-world practice settings. Clinical trials conducted in practice settings
      can demonstrate the degree to which evidence-based treatments are appropriate for larger
      scale dissemination. This study evaluates CBT as a treatment for child anxiety disorders in
      the elementary school clinic setting. A randomized, controlled trial design has been
      employed, comparing immediate treatment and a three-month waitlist. The trial is being
      conducted in several Los Angeles area elementary schools and is only available to children in
      these particular schools. To ensure that the CBT intervention is flexible and capable of
      matching the characteristics of various school settings, clinicians, and referred children, a
      modular treatment approach is employed. The study design includes elements to ensure high
      quality data, such as the use of independent evaluators and tests of treatment fidelity.
      Children, ages 5 to 12 years, are referred by teachers and staff or are identified as having
      high anxiety in concurrent studies. All participating children have DSM-IV diagnoses of
      separation anxiety disorder, generalized anxiety disorder, or social phobia, according to a
      semi-structured diagnostic interview. Therapy and clinical supervision is provided by the
      research team. It is hypothesized that children receiving immediate treatment will have
      significantly lower anxiety scores than children assigned to the waitlist at the
      posttreatment/postwaitlist assessment. If results are favorable, further exploration of
      dissemination of CBT into school clinic settings may be indicated.
    


Intervention name(s): cognitive behavioral therapy
Intervention type(s): Behavioral
Intervention description(s): 1 to 16 weekly sessions of modular cognitive behavioral therapy, each lasting 60-80 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: cognitive behavioral therapy; anxiety disorders; school-based intervention; randomized, controlled trial
False Positive Results in Newborn Hearing Screening
Condition: Deafness
MeSH terms: Deafness
Study type: Observational

Summary: 
      The purpose of this study is to investigate the rate of false-positive results in Newborn
      Universal Hearing Screening Programs and it´s possible causes.
    

Detailed description: 
      False-positive results in Newborn Hearing Screening(NHS) leads to unnecessary parents anxiety
      and increase the cost of the procedure before hospital discharge. Getting to know the
      possible causes will lead to solutions to decrease the number of normal hearing babies that
      fail NHS with Otoacoustic Emissions.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Newborns
      
Keywords: hearing; newborn; otoacoustic emissions
Propranolol Administration and Prevention of Child PTSD in Child Trauma Victims
Condition: Posttraumatic Stress Disorders
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      Twenty-nine pediatric injury patients (ages 10-18) at risk for PTSD were randomly assigned to
      receive either propranolol or placebo in a double-blind placebo controlled design. Medication
      was initiated within 12 hours of hospital admission. At 6-weeks, child PTSD symptoms and
      heart rate (HR) during trauma recall were assessed. We hypothesized that participants who
      received propranolol would report fewer PTSD symptoms and have lower heart rates than those
      who received placebo.
    


Intervention name(s): Inderol (propranolol)
Intervention type(s): Drug
Intervention description(s): Children ingested a propranolol HCL 20 mg/5 ml solution twice daily for 10 days (and taper for 5 days). Medication was initiated within 12 hours post-trauma. Dose was calculated to be 2.5 mg/kg/d with a maximum dose of 40 mg.
Other intervention name(s): propranolol
Intervention MeSH terms: Propranolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: posttraumatic stress disorder; propranolol; inderol; child; trauma; Posttraumatic stress disorders (PTSD)
An Interaction Study of LY3200882 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the effect of itraconazole on the amount of
      LY3200882 in the blood stream and how long the body takes to get rid of LY3200882. The safety
      and tolerability of LY3200882 when given with itraconazole will be evaluated. The study is
      expected to last up to 19 days from the first dose to follow-up (inclusive). Screening will
      occur up to 28 days prior to enrollment.
    


Intervention name(s): LY3200882; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally.; Administered orally.
Intervention MeSH terms: Itraconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Cooking for Health Optimization With Patients
Condition: Cardiovascular Diseases; Cardiovascular Risk Factor; Nutrition Disorders; Diabetes; Hypertension; Cancer; Depression; Obesity; Physical Activity
MeSH terms: Cardiovascular Diseases; Nutrition Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Cooking for Health Optimization with Patients (CHOP) is the first known multi-site
      prospective cohort study with a nested Bayesian adaptive randomized trial in the preventive
      cardiology field of culinary medicine. It is also the first known longitudinal study to
      assess the impact of hands-on cooking and nutrition education on patient outcomes, with those
      classes taught by medical students and other future and current medical professionals who
      have first been trained in those classes on how to integrate diet and lifestyle counseling of
      patients with their respective scopes of clinical practice. CHOP is the primary research
      study of the world's first known medical school based teaching kitchen, The Goldring Center
      for Culinary Medicine at Tulane University School of Medicine. Medical trainees and
      professionals are followed in this study long-term to understand how the classes impact their
      competencies in patient counseling, attitudes about the counseling, and their own diets.
      Patients who consent to being randomized to these classes compared to standard of care are
      studied within the nested Bayesian adaptive randomized trial to understand how the classes
      impact their health outcomes, clinical and food costs, and the costs of health systems caring
      for these patient populations. CHOP is designed as a pragmatic population health trial to
      hopefully improve healthcare effectiveness, equity, and cost by establishing an
      evidence-based, scalable, sustainable model of healthcare intervention targeting the social
      determinants of health, while complementing the pharmacological and/or surgical management of
      patients.
    


Intervention name(s): Treatment
Intervention type(s): Behavioral
Intervention description(s): The intervention educates subjects through the hands-on cooking and nutrition education classes how to buy, cook, store, and consume healthy foods as an adjunct to healthy activity levels and avoidance of such health risks factors as smoking, excessive alcohol intake, and drug use.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Use of MUAC as Basic Criterion for Admission, Follow-up and Exit From the Ambulatory Nutrition Program
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The aim of this study is to provide comprehensive documentation of the relevant results and
      operational implications of this new model using Mid-Upper Arm Circumference (MUAC) as the
      single anthropometric criterion for admission, monitoring and exit of non- complicated in
      Niger.
    

Detailed description: 
      This is a first operational experiment using Mid-Upper Arm Circumference (MUAC) as the single
      anthropometric criterion for the admission, monitoring and exit of the management of
      uncomplicated SAM (Severe Acute Malnutrition) in Niger, specific data as well as data from
      routine program will be collected to allow comprehensive documentation of all relevant
      results and operational implications of this new model. The experiment based on the use of
      the single anthropometric threshold for admission of a Mid-Upper Arm Circumference (MUAC)<120
      mm, which includes both children currently classified as having SAM (currently with PB <115
      mm) and acute malnutrition moderate (MAM, currently with a Mid-Upper Arm Circumference
      (MUAC)<125 mm), as well as a follow-up of children with a Mid-Upper Arm Circumference (MUAC)≥
      120 mm, will identify how children respond to treatment and benefit of the spectrum of acute
      malnutrition.
    

Intervention name(s): MUAC Program; Standard Program
Intervention type(s): Other; Other
Intervention description(s): All children admitted to the PB program will receive standard care according to the national Protocol and that of MSF, including preventive and therapeutic care at admission as well as hospital care in case of clinical complications. There will be no change in the Protocol for the hospital care to the CRENI (Center of Intensive Nutritional Rehabilitation). RUTF (Ready-to-Use therapeutic food) will be distributed on a weekly basis according to the dosage of RUTF in the national protocol.; All children admitted to the standard program will receive standard care according to national and MSF protocols, including preventive and therapeutic care on admission as well as hospital care in case of clinical complications. RUTF will be distributed on a weekly basis according to the dosage of RUTF in the national protocol.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment