bioihbjkbjnl/mcl2 huggingface dataset:
Beyond COVID-19: Supporting Resilience With a Trauma-informed Music Composition Program
Condition: Problems Related to Life-Management Difficulty
Study type: Interventional

Summary: 
      This study explores the feasibility and acceptability of a music composition intervention to
      support resilience in survivors of serious illness hospitalized during the COVID-19 pandemic.
    

Detailed description: 
      This study explores the feasibility and acceptability of a music composition intervention to
      support resilience in survivors of serious illness hospitalized during the COVID-19 pandemic.
      The pandemic introduced widespread trauma for patients facing hospitalization. Therapeutic
      music interventions have demonstrated positive psychological effects, but none have explored
      the specific trauma-informed aspects of a composition-mentor program, as well as the specific
      impact of music composition on resilience-related traits.

      Researchers implemented an adapted version of the New York Philharmonic Very Young Composers
      program (VYC): trained composer-mentors guide participants through four web-based sessions to
      elicit and develop participants' unique musical ideas into finished compositions.
      Participants are then invited to view a string quartet performance of their compositions. The
      Brief Resilience Scale [BRS] and New General Self-Efficacy Scale [NGSE] are administered
      pre-intervention, post-intervention, and post-performance.
    

Intervention name(s): music composition
Intervention type(s): Other
Intervention description(s): 4-session music composition program for participants lead by a composer-mentor, includes optional viewing of online string quartet performances of final musical scores
Intervention model: Single Group Assignment
Intervention model description: case series
Masking: None (Open Label)
Primary purpose: Prevention
Integrating Motivational Interviewing With Cognitive-behavioral Therapy
Condition: Anxiety Disorders and Symptoms; Depression; Life Style
MeSH terms: Depression; Anxiety Disorders
Study type: Interventional

Summary: 
      Cognitive-behavioral therapy (CBT) is efficacious for anxiety disorders and depression, but
      not all patients achieve remission, and dropout is considerable. Motivational interviewing
      (MI) may strengthen motivation to change, and influence non-response and dropout. Research
      shows that MI as a pretreatment to CBT produces moderate effects compared to CBT alone.
      Studies integrating MI with CBT (MI-CBT) throughout treatment are scarce. The present study
      explored the feasibility of MI-CBT in routine psychiatric care, and compared CBT alone to
      MI-CBT for anxiety disorders, depression, and unhealthy lifestyle behaviors. The Anxiety,
      Depression, Diet, Alcohol, Physical activity, and Tobacco (ADDAPT) feasibility study had a
      randomized controlled design, and data were analyzed using hierarchical regression.
    


Intervention name(s): Cognitive-behavioral therapy; Integrated motivational interviewing and cognitive-behavioral therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Psychological treatment focusing on changing cognitions and behaviors using information processing theory and learning theory approaches.; Motivational interviewing is a psychological treatment approach focusing on increasing motivation by eliciting patient talk favoring behavior change and resolving patient ambivalence about change.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Interval Training, Inflammation and Immune Function
Condition: Aging; Disease
Study type: Interventional

Summary: 
      PURPOSE: The purpose of this study is to investigate whether High Intensity Interval Training
      (HIIT)can improve the health and wellbeing of pre-diabetic elderly adults. In particular,
      there is specific interest in describing the effects of an interval exercise program on
      inflammatory state and immune function.

      DESIGN: Subjects will be sedentary, 65 to 80 years old adults, with prediabetes as defined by
      fasting plasma glucose (100 to 125 mg/dl). Before and after a 10-12 week High Intensity
      Interval Exercise training program subjects will undergo several tests including: 1) a
      maximal treadmill test, 2) an Oral Glucose Tolerance Test, 3) muscle biopsy, 4) body
      composition, 5) several physical function tests and 6) other health related measures
      including lung function, arterial stiffness and several blood measures (e.g. liver enzymes,
      kidney function).

      DATA ANALYSES & SAFETY ISSUES: As there are no comparison groups, data analyses will consist
      of performing paired t-tests on pre and post exercise training values for each of the
      measurement variables of interest. In addition, the data will be used to provide power
      calculations for future grant proposals. High Intensity Interval Training is a very safe
      exercise modality. The regular use of vigorous intensity exercise intervals have been used
      extensively in exercise training. In fact, the exercise intervals will start at levels lower
      and will be of shorter duration than were used during the maximal exercise test. They will
      then be carefully and slowly made to be more challenging as each subject is able to safely
      tolerate.

      HYPOTHESIS: The investigators hypothesize that HIIT will result in significant improvements
      in markers of inflammation, immune system markers and other health-related risk factors.
    


Intervention name(s): High Intensity Interval training
Intervention type(s): Behavioral
Intervention description(s): all subjects will undergo high intensity interval training 3 x per week for 10-12 weeks. the intervals of high-intensity (~85% of maximal capacity) will be 5 to 10 bouts of 30 seconds at this intensity with rest periods in between intervals that range from 30 seconds to 2 minutes
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: High Intensity Interval Training
Value of Ondansetron Medication vs Inhaled Isopropyl Therapy in the Emergency Department (VOMIITED)
Condition: Nausea; Vomiting
MeSH terms: Emergencies; Vomiting
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study will compare two different ways to relieve nausea and vomiting in the Emergency
      Department. The usual treatment for nausea/vomiting is a drug called Zofran, but new studies
      have suggested that smelling alcohol pads can also help to relieve nausea and vomiting.
    

Detailed description: 
      Emergency physicians commonly use medications to alleviate nausea and vomiting. The
      medication Ondansetron is used in the emergency department and after surgery for this
      purpose. Inhaled isopropyl alcohol has been successfully used to decrease nausea and vomiting
      after surgery. No trial has compared inhaled isopropyl alcohol to Ondansetron in a clinical
      trial.

      The author proposes to prospectively investigate extension of the established antiemetic
      efficacy of inhaled isopropyl alcohol for undifferentiated nausea in Emergency Department
      patients to the 30-minute post-intervention point that has been reported to be the frequent
      juncture of symptom relief. By introducing prolonged intervention, and re-dosing of
      established benefit, into this research, the author aims to reproduce the sustained
      antiemetic efficacy of inhaled isopropyl alcohol for undifferentiated nausea as demonstrated
      for post-operative nausea and vomiting.
    

Intervention name(s): Inhaled Isopropyl Alcohol (IPA); Oral Dissolvable Tablet Zofran (ondansetron)
Intervention type(s): Other; Drug
Intervention description(s): Three doses within 60 minutes. Doses will occur at 0 minutes, 30 minutes, and 60 minutes. Each dose consists of 3 inhalations of one IPA prep pad. A new prep pad is used at each dose.; Single dose 4 mg tablet at 0 minutes.
Other intervention name(s): IPA; alcohol prep pad; OZ
Intervention MeSH terms: Ethanol; Ondansetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Isopropyl alcohol; Zofran; antiemetics
Adrenomedullin Effect on Migraine Without Patients
Condition: Headache, Migraine
MeSH terms: Migraine Disorders; Headache
Study type: Interventional

Summary: 
      AM is a naturally occurring peptide in the body and consists of 52 amino acids. AM belongs to
      the calcitonin gene-related peptide (CGRP) superfamily and has several structural,
      physiological and pharmacological similarities to CGRP, intermdine and amylin. In a
      randomized double-blind, placebo controlled cross-over design 20 migraine patients without
      aura recruited to receive infusion of adrenomedullin or placebo (saline).
    

Detailed description: 
      AM is a naturally occurring peptide in the body and consists of 52 amino acids. AM belongs to
      the calcitonin gene-related peptide (CGRP) superfamily and has several structural,
      physiological and pharmacological similarities to CGRP, intermdine and amylin. In a
      randomized double-blind, placebo controlled cross-over design 20 migraine patients without
      aura recruited to receive infusion of adrenomedullin or placebo (saline).

      A pilot study on healthy volunteers were conducted to determine tolerable dose of
      adrenomedullin to the main study.
    

Intervention name(s): Adrenomedullin; Saline
Intervention type(s): Other; Other
Intervention description(s): Adrenomedullin is a naturally found in the human body and has strong vasoactive properties.; Placebo
Intervention MeSH terms: Adrenomedullin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Safety and Efficacy Trial of Testosterone Undecanoate
Condition: Male Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine if oral testosterone undecanoate is effective and
      safe in the treatment of low testosterone in men.
    


Intervention name(s): Oral testosterone undecanoate
Intervention type(s): Drug
Intervention description(s): Initial dose 200 mg T, BID; dose titration Days 42 and/or 84 based on serum T levels obtained 3-5 hours post AM dose on Days 30 and 72. Dosages increased or decreased in 50 mg increments.
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: testosterone; male hypogonadism; low testosterone
Pharmacokinetics Study of GSK1265744 in Subjects With Severe Renal Impairment
Condition: Infection, Human Immunodeficiency Virus; HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK1265744 (744) is an integrase strand transfer inhibitor (INSTI) currently in development
      for both the treatment and prevention of human immunodeficiency virus (HIV) infection. Renal
      elimination of unchanged 744 is extremely low, with no parent 744 detected in the urine after
      a single 30 mg radiolabeled dose. Despite the minimal contribution of renal clearance on
      overall 744 elimination, renal impairment may potentially inhibit some pathways of hepatic
      and gut drug metabolism and transport, and as a result may impact 744 pharmacokinetics. The
      current Food and Drug Administration (FDA) draft guidance for renal impairment studies
      suggests that a pharmacokinetic (PK) study in patients with renal impairment be conducted
      even for those drugs primarily metabolized or secreted in bile.

      The study will be comprised of two cohorts (severe renal impairment and normal renal
      function) of 8 subjects each. Upon enrolment, each subject will be admitted to the study
      center and undergo serial PK sampling following a single dose of oral 744 30 milligrams (mg).
      Subjects will return to the clinic for follow-up evaluations 10-14 days after the 744 30 mg
      dose.
    


Intervention name(s): GSK1265744 30 mg
Intervention type(s): Drug
Intervention description(s): White to almost white coated oval tablets with unit dose strength of 30 mg for oral administrations.
Intervention MeSH terms: Cabotegravir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Pharmacokinetics; GSK1265744; Severe Renal Impairment
Effects of Cervical Spine Manipulation on Gait
Condition: Cervicalgia
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The purpose of the study is to see if manipulation of the neck will change the way people who
      may or may not have neck pain, walk under differing conditions.
    

Detailed description: 
      Volunteers in this study will be asked to do the following: 1) complete a series of
      questionnaires about health status and undergo physical screening of neck to make sure that
      manipulation will not be harmful; 2) walk in socks or bare feet across a computerized mat
      under 3 conditions - normal walking pace, walking while looking up and down repeatedly; and
      walking while looking left and right repeatedly; 3) have one of 2 manual therapy
      interventions to the neck; 4) repeat the walking across the computerized mat under those same
      3 conditions.

      The 2 randomly assigned interventions are: cervical manipulation, or cervical contact. If
      assigned the manipulation, volunteers will lie face up and the trained therapist will move
      the joints in the neck in a gentle, but short and sharp manner which may produce a slight
      'pop' or 'click'. If volunteers are assigned the cervical contact, they will lie on their
      back and the trained therapist will gently hold the head and neck for 45 to 60 seconds as
      they quietly relax.
    

Intervention name(s): Manipulation; Manual Contact
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Cervicalgia
Contribution of Percutaneous Endoscopic Caecostomie in the Management of Severe Constipation Refractory to Medical Treatment
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      The investigators' study aims to compare the results of percutaneous endoscopic caecostomie
      (CPE) to optimal medical therapy in the treatment of patients with constipation refractory to
      medical treatment. The primary endpoint will be the quality of life assessed by the
      Gastrointestinal Quality Of Life Index (GIQLI) at one year. The secondary endpoints are
      digestive symptoms, Kess's constipation scores and Cleveland's incontinence score, tolerance
      of the Chait TrapdoorTM caecostomy catheter (CTCC) and the collection of possible
      complications. The patients included must meet the classification criteria of Rome III, have
      an elongated colonic transit time, have had a complete colonoscopy and be refractory to
      medical treatment including at least one stimulant laxative or suppositories or enemas
      retrograde.
    


Intervention name(s): Chait Trapdoor caecostomie catheter; continuation of optimal medical therapy
Intervention type(s): Device; Drug
Intervention description(s): implantation of the Chait Trapdoor caecostomie catheter; continuation of treatment with laxative and / or suppositories and / or enemas retrograde At 12 months : implantation of the Chait Trapdoor caecostomie catheter
Other intervention name(s): Chait Trapdoor caecostomie catheter
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation Study of Fear of Cancer Recurrence: Detection, Measure and Risk Factors in Lymphoma Survivorship
Condition: Lymphoma
MeSH terms: Lymphoma; Recurrence
Study type: Interventional

Summary: 
      Cancer survivorship has become an important aspect of oncology research due to the risk of
      physical and psychosocial complications. These latter concerns 50 % of patients. So, the aim
      of this research is to measure frequency and intensity of one of these issues: the fear of
      cancer recurrence (FCR) in the lymphoma survivorship beginning, at M0.
    

Detailed description: 
      Indeed, in a recent work published by our team, several complication types in cancer
      survivorship has been identified: physical but also psychosocial disorders, which can lead to
      quality of life deterioration. The FCR in lymphoma pathology isn't yet documented and only a
      few studies concern the risk factors determination (age, sex, disease stage, treatment type,
      level of education, co-morbidity, isolation (familial status), financial resources, character
      trait in others cancers. Moreover, the FCR can be amplified by familial (young children) or
      professional responsibilities (self-employed profession). The consequences of FCR are poorly
      evaluated and are, however, potentially manifold: psychologic disorders, psychotropic
      consummation, delay of return to work and quality of life deterioration.

      So, FCR is an innovating research project, which studies the FCR incidence in the beginning
      of lymphoma After-Cancer (AC) M0 and also the associated risk factors we can class in three
      types: 1. "Patient" factors (age, sex, habitat: rural/urban, familial status, level of
      education, financial resources, co-morbidity), 2. "disease" factors: histological type,
      disease stage, risk factor, 3. "treatment" factors : conventional versus intensified.
      Moreover, we will study the consequences of FCR M0 upon quality of life and if there is a
      need of psychotherapy from the very beginning of after-cancer phase, for high intensity FCR.

      This present study is based on an interventional (with an analysis of human blood sample)
      prospective cohort, treated with anthracycline-containing regimens. This is a monocentric
      study which takes place in the Institut University du Cancer of Toulouse. The evaluation uses
      the scale of Fear of Cancer Recurrence Inventory (FCRI). The inclusion period lasts 2 years
      and patients will be followed during 2 years with a measure at M0, M12 and M24.
    

Intervention name(s): Questionnaires/Scales; Human blood sample
Intervention type(s): Other; Other
Intervention description(s): Scale of Fear of Cancer Recurrence Inventory, Hospital Anxiety and Depression Scale, Evaluation of stress and life quality.; The intervention is based on blood test.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Lymphoma; Cancer survivorship; Fear
Performance of Endoscopic Submucosal Dissection According to the Sedation Method
Condition: Early Gastric Cancer; Gastric Adenoma
MeSH terms: Adenoma
Study type: Interventional

Summary: 
      Although proper sedation is mandatory for endoscopic procedures such as endoscopic submucosal
      dissection, the effects of sedation on ESD performance and complications have not been fully
      evaluated. In the investigators previous retrospective study, en bloc resection and complete
      resection rates, and procedure time could be improved by sedation with continuous propofol
      infusion with opioid administration by anesthesiologists. However, there are several
      limitations to the study including retrospective design. The investigators aimed to evaluate
      the relationship among sedation methods, satisfaction of endoscopists or patients, clinical
      outcomes, and complications after endoscopic submucosal dissection for gastric neoplasia.
    


Intervention name(s): Intermittent midazolam/propofol injection controlled by endoscopist; Continuous propofol infusion with opioid administration
Intervention type(s): Procedure; Procedure
Intervention description(s): In this arm1, sedation during endoscopic submucosal dissection is controlled by endoscopists.
First, pethidine 50 mg with midazolam 0.05 mg/kg are injected in a bolus fashion.
When the patient seems to be discomfort or the patient's movements were observed, endoscopists should check the Modified Observer Assessment of Alertness/Sedation (MOAAS).
If MOAAS is 5 or 6, propofol 0.25 mg/kg will be injected. Otherwise, pethidine 12.5 mg will be injected.; In this arm2, sedation during endoscopic submucosal dissection is controlled by anesthesiologists.
First, remifentanil 0.5 ug/kg with propofol 0.5 mg/kg are injected in a bolus fashion.
Then, remifentanil 0.08 ug/kg/min and propofol 2 mg/kg/h are infused continuously.
When the patient seems to be discomfort or the patient's movements were observed, anesthesiologists should check the MOAAS.
If MOAAS is 5 or 6, infusion rate of propofol will be increased by 0.5 mg/kg/h. Otherwise, infusion rate of remifentanil will be increased by 0.02 ug/kg/min.
Intervention MeSH terms: Midazolam; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Endoscopic submucosal dissection; Sedation; Propofol; Midazolam