bioihbjkbjnl/mcl2 huggingface dataset:
Functional and Clinical Long-Term Outcome of Ewing Sarcoma Treatment
Condition: Sarcoma, Ewing's
MeSH terms: Sarcoma; Sarcoma, Ewing; Neuroectodermal Tumors, Primitive, Peripheral
Study type: Observational

Summary: 
      The purpose of the study is to assess the functional outcome, quality of life and late
      sequelae in a representative sample of 600 long-term survivors of Ewing sarcoma and to build
      a unique clinical and functional data pool of the underlying cohort of 3000 Ewing sarcoma
      patients with a follow-up of 3 decades.
    

Detailed description: 
      Trial objective: As survival rates of bone sarcoma patients have been raised owing to
      improved treatment strategies the focus of investigations is now on the medical, social, and
      economic sequelae of intensive multimodal treatment. This study aims to assess the functional
      outcome, quality of life and late sequelae in a representative sample of long-term survivors
      of Ewing sarcoma. The data recorded combined with standardized treatment data covering a
      30-year period will produce a data pool that is unique for its magnitude and will be used for
      the development of guidelines for further improvements of future bone sarcoma treatment.

      Working plan: The working plan provides for the assessment of functional outcome and quality
      of life by means of validated tools (TESS, SF36, PEDQOL) and objectively measuring daily
      activity patterns by using the Step Activity Monitor (SAM) in 600 long-term Ewing sarcoma
      survivors and a control group of 300 matched healthy subjects. Information on sarcoma
      treatment and follow-up is obtained by re-structuring and complementing the database of the
      relevant patient cohort (n=3000) from four consecutive nationwide and international clinical
      trials between 1980 and 2008. Procedures of local treatment will be evaluated regarding
      functional outcome, quality of life, and survival probability and prognostic factors
      predicting long-term outcome will be identified.

      Exploitation of results: The results will be presented at scientific meetings and will be
      published in international journals. Guidelines will be developed regarding improvements in
      the treatment, rehabilitation, and social integration of bone sarcoma patients to be utilized
      in guiding patients and in the decision process of medical professionals regarding their
      treatment. In the long run, the evidence based guidelines on treatment and follow-up are to
      be transferred into the health system.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Ewing sarcoma survivors and 1:2 matched control group of healthy subjects
      
Keywords: bone tumors; long-term function; daily activity; late sequelae
Randomized Study on Salt Intake and Energy Metabolism
Condition: Healthy
Study type: Interventional

Summary: 
      To perform a randomized, double-blind clinical study on the effects of an increased salt
      intake on metabolic, cardiovascular and immunological parameters and the gut microbiota
    


Intervention name(s): Salt; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 10 capsules daily for 14 days; 10 capsules daily for 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Calorimetry; Blood pressure; Immunophenotyping; Gut microbial composition
Pilot Study of Exposure Therapy for Posttraumatic Stress Disorder
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this project is to examine the feasibility of a culturally adapted, manual
      based Prolonged Exposure therapy intervention for the treatment of Spanish-speaking Puerto
      Ricans with posttraumatic stress disorder
    

Detailed description: 
      This project seeks to lay the foundation for an effectiveness trial that will lead to the
      advancement of treatments for PTSD among Spanish-speaking Latinos, particularly Puerto
      Ricans. This area of research is important in light of the limited treatment options
      currently available for Spanish-speakers with PTSD and the long-term negative consequences of
      this condition. Participants in this study are recruited by referral from mental health
      providers in a general health setting. Patients meeting criteria for enrollment will be
      randomly assigned to receive either Prolonged Exposure therapy or treatment as usual.
      Assessments for all participants will be collected at baseline, week 8, and week 16 after
      randomization.
    

Intervention name(s): Prolonged Exposure; Usual care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 15 psychotherapy sessions focused on helping clients overcome avoidance behaviors and emotionally process trauma-related memories; Per usual care, patients are referred to a mental health provider within the health care setting.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Posttraumatic stress disorder; Prolonged exposure; Cognitive behavior therapy
A Study in Subjects With Parkinson's Disease to Evaluate the Safety and Tolerability of Titration and Continuous Subcutaneous Infusion of ABBV-951 in an Outpatient Environment
Condition: Parkinson's Disease (PD)
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of 4
      weeks of continuous infusion with ABBV-951 in adult subjects with Parkinson's Disease (PD).
    


Intervention name(s): ABBV-951
Intervention type(s): Drug
Intervention description(s): powder for solution
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: carbidopa; levodopa
Study of a Severe Acute Respiratory Syndrome CoV-2 (SARS-CoV-2) Virus-like Particle (VLP) Vaccine in Healthy Adults
Condition: Covid19
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a VLP SARS-CoV-2 vaccine study of a vaccine developed in Turkey and manufactured
      according to Good Manufacturing Practices (GMP) requirements. Preclinical toxicology studies
      on experimental animals are to be concluded. The purpose of this Phase I study is to examine
      the safety, tolerability, and immunogenicity of the protective VLP vaccine against
      SARS-CoV-2, which will be administered by a double-blind, randomized method, in two different
      doses (low dose and high dose).
    

Detailed description: 
      This phase I study is designed as double-blinded, randomised, placebo controlled, three-armed
      study composed of two different dose arms of protective VLP vaccine (harboring M, N, E, and
      hexapro modified S proteins of SARS-CoV-2 virus) against SARS-CoV-2 in dose escalations
      (first low dose group, followed by high dose group) and placebo arm. Each dose of vaccine
      will be defined as a cohort in itself, with vaccine administration to 12 participants and
      placebo administration to 6 participants. After completion of low-dose group, decision of
      switch to high-dose will be taken by the Independent Data Monitoring Committee and study will
      continue accordingly.

      The study will be completed in 12 months.

      All injections will be done subcutaneously.
    

Intervention name(s): SARS-CoV-2 VLP Vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): VLP adjuvanted vaccine; 0.9% NaCl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Virus-like Particles harboring S, M, N, E antigens; SARS-CoV-2; K3-CpG ODN; Alum
Impact of Oxidized Silver Wound Dressings on Wound Bacteria
Condition: Wounds
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      Chronic non-healing wounds considerably impact quality of life in affected patients and are a
      substantial burden on the Canadian health care system. Microbes colonizing a chronic wound
      play an important role in impeding effective healing. Chronic wounds are colonized by
      polymicrobial communities and no single organism can be seen as causal. Only a small fraction
      of wound bacteria are cultured by diagnostic tests and studies have shown little agreement
      between culture and molecular based approaches, therefore an effective diagnostic for wound
      microbes is required. It is know that the composition of the microbial community associated
      with a wound changes as it heals although the causal relationship is somewhat unclear.
      Although not very effective in treating chronic non-healing wounds, antibiotics are often
      administered, contributing to concerns of antibiotic resistance. The wound dressings produced
      by Exciton Technologies Inc. (ETI) effectively aid in the healing process in chronic wounds
      through unknown mechanisms. ETI's wound dressings contain a combination of silver salts with
      three different valence, +1, +2 and +3 that have antimicrobial activity and are effective in
      reducing biofilm formation in vitro. However, it is not known how these silver salts impact
      microbial ecology of the wound and the role this plays in wound healing. The objectives of
      this research are to develop a new diagnostic tool based on molecular characterization of
      wound sites so as to predict how to best treat wounds and to identify new microbes to be
      targeted by ETI's technology. This project will utilize molecular microbial ecology for the
      assessment and evaluation of topical silver interventions, gaining insight into the
      management of chronic infection. Substantiating the microbiota-modifying effectiveness of
      silver wound dressings towards increasing clinician and patient understanding to improving
      clinical outcomes.
    


Intervention name(s): Exsalt SD7, Exsalt T7 Wound Dressing
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Blood Pressure Outcomes With Liraglutide Therapy
Condition: Type 2 Diabetes; Systolic Hypertension
MeSH terms: Hypertension; Isolated Systolic Hypertension; Diabetes Mellitus, Type 2; Systolic Murmurs
Study type: Interventional
Phase: Phase 4

Summary: 
      Purpose:

      The purpose of this study is to further study the mechanism by which liraglutide, a
      relatively new anti-hyperglycemic medication, might lower blood pressure in patients with
      Type 2 diabetes and high blood pressure.
    

Detailed description: 
      Background: Type 2 diabetes is a worldwide health problem. As the reduction in blood pressure
      has been coupled to improvements in overall cardiovascular outcomes, the control of
      hypertension has become an important modifiable risk factor in the overall care of the
      patient with Type 2 Diabetes, in addition to glycemic control. Recently, several large-scale
      clinical trials evaluating the glucose-lowering effects of the anti-hyperglycemic agent,
      liraglutide (a glucagon-like peptide-1 receptor agonist), have demonstrated a modest yet
      persistent anti-hypertensive effect in patients with Type 2 diabetes.

      Study Objectives: Accordingly, the goal of this small study is to understand whether the
      blood pressure lowering effect of liraglutide is coupled to the release of vasoactive
      mediators which may stimulate natriuresis and/or diuresis and lower systolic blood pressure.

      Study Design: Randomized, double-masked, cross-over study with treatment of liraglutide or
      placebo for 3 weeks, with an intervening washout period for 3 weeks, and cross-over to
      identical treatment with placebo or liraglutide for 3 weeks.

      Study Patients: 20 patients with Type 2 Diabetes and Systolic Hypertension

      Endpoints: Change in vasoactive hormones, 24-hour ambulatory blood pressure, urinary sodium
      excretion patterns.
    

Intervention name(s): Liraglutide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single cross-over study, 1 arm starting with liraglutide for 3 weeks crossed-over to placebo for 3 weeks, and 1 arm starting with placebo with cross-over to liraglutide for 3 weeks.; Single cross-over study, 1 arm starting with liraglutide for 3 weeks crossed-over to placebo for 3 weeks, and 1 arm starting with placebo with cross-over to liraglutide for 3 weeks.
Other intervention name(s): Victoza
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Type 2 Diabetes; Hypertension; Liraglutide; GLP-1
Guided Self-Help for Depression in Parkinson's Disease
Condition: Depression; Parkinson's Disease
MeSH terms: Parkinson Disease; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The purpose of this project is to develop and pilot-test a guided cognitive-behavioral
      self-help program for mild-to-moderate depression in Parkinson's disease (dPD). We will
      pilot-test the guided self-help treatment on 20 people with PD and their caregivers. The
      manual will be revised based on participant feedback. Several feasibility measures regarding
      the guided self-help program (i.e., recruitment, retention, enjoyment, helpfulness,
      adherence) will also be assessed. Moreover, preliminary estimates of effect size for this
      guided self-help program will be calculated and used in future research. We hypothesize that
      people with PD will report decreases in depression, anxiety, and negative thoughts and
      improvements in quality life and sleep and that caregivers will report decreases in burden
      after participating in the guided self-help program
    

Detailed description: 
      To our knowledge, Cognitive-Behavioral self-help interventions remain unexplored for
      depression in PD to date. The results of this study will be used to support future treatment
      development efforts for depression and other psychiatric complications in PD that may improve
      the access to and quality of mental health care in this medical population.
    

Intervention name(s): Guided Cognitive-Behavioral Self-Help
Intervention type(s): Behavioral
Intervention description(s): Participants will complete the study treatment at home. Bi-weekly telephone support will be provided by study staff.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; Parkinson's disease; Cognitive-Behavioral Treatment
A Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD1446 Administered for 4 Weeks in Elderly Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the safety, tolerability and pharmacokinetics (PK) of two
      doses of AZD1446 or placebo in subjects when given for 4 weeks.
    


Intervention name(s): AZD1446; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Solution, oral, for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: AZD1446; to investigate safety and tolerability in Healthy subjects during 4 weeks of administration
Baclofen for the Treatment of Cocaine Dependence - 1
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy and safety of baclofen for the treatment
      of cocaine dependence.
    

Detailed description: 
      Double-blind, placebo-controlled, parallel design trial of baclofen for the treatment of
      cocaine dependence
    

Intervention name(s): Baclofen; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Dose escalation 10-60mg (week 1) 60 mg (weeks 2-7) Dose taper (week 8); Placebo
Intervention MeSH terms: Baclofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cocaine Dependence
Protracted Effect of the Ultrasound-guided Saphenous Block
Condition: Arthrosis, Unspecified, Ankle and Foot
MeSH terms: Osteoarthritis; Joint Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      This study focuses on optimizing the postoperative pain treatment after major foot and ankle
      surgery by prolonging the duration of the ultrasound-guided saphenous block. The currently
      used single shot saphenous block only covers half of the pain intensive period from the
      saphenous territory, which results in a sharp, break-through pain requiring opioids. The
      hypothesis is that this protracted mixture will keep the patients free of pain without the
      use of opioids for the entire pain intensive period and thus increase rehabilitation and
      patients' satisfaction.
    

Detailed description: 
      Half of the patients will receive a single shot saphenous block with 10 mL
      bupivacaine-adrenalin and 1 mL of sodium chloride solution, while the other half will receive
      10 mL of bupivacaine-adrenalin and 1 mL of dexamethasone.

      The block is strictly a sensory block because it is a selective, sub-sartorial saphenous
      block at mid-thigh level without any anesthetic effect on the femoral nerve.

      The adjuvant dexamethasone has increasingly become a subject of interest regarding a
      protracted effect, which has been shown in several studies. However, the precise mechanism of
      action remains speculative, and the results are contradictory regarding the discussion
      whether the effect is systemic or local. The effect may stem from decreased nociceptive
      C-fibre activity via a direct action on glucocorticoid receptors and inhibitory potassium
      channels. Another suggestion is a vasoconstrictive effect, which reduces the systemic uptake
      of local anaesthetics or a systemic anti-inflammatory effect.

      Prolonging the effect of the single shot saphenous block by adding dexamethasone will reduce
      the need for opioids, which will reduce the risk of adverse effects like nausea, vomiting and
      respiratory depression. Furthermore, newer studies show that inadequate pain alleviation in
      the early postoperative period is a risk factor in developing chronic persistent pain.
    

Intervention name(s): Bupivacaine-adrenaline; Dexamethasone; Sodium chloride
Intervention type(s): Drug; Drug; Other
Intervention description(s): 50 mg bupivacaine and 50 μg adrenalin; 4 mg; 1 mL of sodium chloride solution as placebo
Other intervention name(s): Marcain-adrenalin; Dexagalen; NaCL
Intervention MeSH terms: Dexamethasone; Epinephrine; Racepinephrine; Bupivacaine; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Progressive Strength Training in Spinal Muscular Atrophy
Condition: Muscular Atrophy, Spinal
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Atrophy
Study type: Interventional

Summary: 
      The proposed feasibility study is necessary to test if children and young adults will
      participate in and adhere to a 12-week, home-based, supervised progressive strength training
      exercise program and to obtain preliminary data that will subsequently allow us to determine
      the safety and impact of strength training in spinal muscular atrophy. Our pilot study will
      address 3 aims: (1) Ascertain the feasibility of, and potential barriers to, participation in
      and adherence to a 12-week home-based, supervised, progressive strength training exercise
      program in children and young adults aged 5-21 years with SMA types II and III; (2) Determine
      the safety and tolerability of progressive strength training in a pilot study sample of
      children and young adults with SMA types II and III; and (3) Determine candidate outcome
      measures.
    


Intervention name(s): Progressive strength training
Intervention type(s): Other
Intervention description(s): the systematic increase in resistance weights
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spinal muscular atrophy; Neuromuscular disorder; Progressive strength training; Children
Improving Emotion Regulation in Adolescents With ADHD
Condition: Adhd
Study type: Interventional

Summary: 
      The purpose of our study is to examine the impact of a program that provides emotion
      regulation skills for adolescents aged 11-16 with Attention-Deficit/Hyperactivity Disorder
      (ADHD) and poor emotion regulation. The program is called RELAX (Regulating Emotions Like An
      eXpert). RELAX is an experimental intervention that may equip adolescents with emotion
      regulation and conflict management skills and includes parent involvement to help parents
      support adolescents' use of these skills.
    

Detailed description: 
      Regulating Emotions Like An eXpert (RELAX) consists of 8 weekly 90-minute group sessions and
      1 booster session 8 weeks after the completion of the RELAX intervention. The first 60
      minutes of each group involve separate parent and adolescent groups. Adolescents (ages 11-16)
      attend an emotion regulation and conflict management skills group, while parents attend a
      group focused on how to support utilization of these skills in adolescents at home and school
      through use of modeling their own emotion regulation skills and use of supportive emotion
      socialization practices. For the final 30 minutes of the session, parents and adolescents
      combine and complete a collaborative activity and skill rehearsal homework is discussed for
      the week. Homework will be discussed at the beginning of the separate group meetings the
      following week. The primary overall goal of the RELAX intervention is to assist adolescents
      and parents in traveling down the Path of RELAXation by working on the three C's
      (communication, coping, and conflict management skills). A multimethod assessment of
      emotional, social, and family functioning will be assessed pre- and post-intervention and at
      an 8 week follow-up.
    

Intervention name(s): RELAX
Intervention type(s): Behavioral
Intervention description(s): Regulating Emotions Like An eXpert (RELAX) consists of 8 weekly, 90-minute sessions delivered (60 minutes of parents and adolescents meeting separately, 30 minutes of a combined meeting) in a group format. RELAX equips adolescents with emotion regulation and conflict management skills. This program includes a parent involvement component designed to help parents support adolescents' use of these skills. Each week skills will be discussed and practiced in group, and a skills rehearsal homework activity will be assigned. Following the program, an 8-week follow-up review session will be offered. Additionally, a single 60 minute focus group will be held following the review session to solicit parent and adolescent feedback on the intervention.
Intervention model: Single Group Assignment
Intervention model description: Pilot trial to finish developing and refining the intervention
Masking: None (Open Label)
Primary purpose: Treatment