bioihbjkbjnl/mcl2 huggingface dataset:
Home-Based Mental Health Evaluation (HOME)
Condition: Suicide and Self-harm
MeSH terms: Suicide; Self-Injurious Behavior
Study type: Interventional

Summary: 
      The purpose of this project is to investigate the effectiveness of the Home-Based Mental
      Health Evaluation (HOME) program, which is an innovative and culturally-relevant suicide
      prevention intervention for Veterans aimed at increasing treatment engagement and decreasing
      suicide risk following psychiatric hospitalization, a period of heightened suicide risk.
    

Detailed description: 
      The purpose of this project is to investigate the effectiveness of the Home-Based Mental
      Health Evaluation (HOME) program, which is an innovative and culturally-relevant suicide
      prevention intervention for Veterans aimed at increasing treatment engagement and decreasing
      suicide risk following psychiatric hospitalization, a period of heightened suicide risk. The
      research project employs a multi-site two-arm interventional trial design to study the
      effectiveness of the HOME program. Effectiveness of the treatment will be evaluated by
      comparing Veterans receiving the HOME program at two active treatment sites, Denver and
      Philadelphia Department of Veterans Affairs Medical Centers (VAMCs), to with those receiving
      care at two control sites, Houston and Portland VAMCs. The current protocol describes
      procedures as they will occur at all sites, including those completed locally at the Denver
      VAMC, which is the lead site for the study.
    

Intervention name(s): HOME
Intervention type(s): Behavioral
Intervention description(s): Prior to discharge from the inpatient unit, the HOME program provider or another member of the research team, will meet individually with the Veteran to provide further information regarding the HOME program intervention. Efforts are made to schedule the initial phone call and home visit that occur during the first week after discharge. Following the home visit, the HOME provider may continue to have weekly contact with the Veteran via the telephone or in person until he or she is disenrolled following engagement in outpatient care. "Engaged in care" is defined as attendance at two individual outpatient mental health appointments or engagement in equivalent or elevated care as determined by the PI. All clinical contacts with the Veteran may include the following: suicide risk assessment, review and modification of the Veteran's safety plan, review and modification of the discharge plan, involvement of the Veteran's support system, and facilitation of engagement in outpatient care.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: treatment engagement
Drug-Drug Interaction Study Between EDP-938, Tacrolimus, Dabigatran, Rosuvastatin and Midazolam in Healthy Subjects
Condition: RSV Infection
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects
      of tacrolimus, dabigatran, rosuvastatin and midazolam on the Pharmacokinetics and Safety of
      EDP-938 in Healthy Subjects
    


Intervention name(s): EDP-938; EDP-938; EDP-938; Tacrolimus; Dabigatran; Rosuvastatin; EDP-938; Midazolam
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subjects will receive EDP-938 once daily on Days 10 through 27 (Part 1); Subjects will receive EDP-938 once daily on Days 5 through 15 (Part 2); Subjects will receive EDP-938 once daily on Days 5 through 15 (Part 3); Subjects will receive tacrolimus once daily on Day 1 and Day 24; Subjects will receive dabigatran once daily on Day 1 and Day 13; Subjects will receive rosuvastatin once daily on Day 1 and Day 13; Subjects will receive EDP-938 once daily on Days 3 through 16 (Part 4); Subjects will receive midazolam once daily on Day 1 and Day 16
Intervention MeSH terms: Midazolam; Dabigatran; Rosuvastatin Calcium; Tacrolimus
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: 4-Part Single Group study
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: drug-drug interaction
Hypofractionated Radiation Therapy With Concomitant Boost in Treating Women After Breast Conserving Surgery
Condition: Breast Cancer Female
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This phase II study is to evaluate the safety of hypofractionated whole breast radiation
      (HFRT) with simultaneous tumor bed boost(SIB) in women with early breast cancer after
      breast-conserving surgery.
    

Detailed description: 
      OBJECTIVES:

      Primary:

      To determine the toxicity with adjuvant hypofractionated whole breast radiation with
      simultaneous tumor bed boost (SIB) in women with early breast cancer after breast conserving
      surgery.

      Secondary:

      To determine the short term cosmetic and quality of life of the participants treated with
      this regimen.

      To determine the local control of the participants treated with this regimen.

      OUTLINE: Patients undergo adjuvant hypofractionated whole breast radiation with simultaneous
      tumor bed boost once daily a week for 3 weeks. Toxicity, quality of life and cosmetic result
      is assessed before radiation, at the end of the radiation, within 2, 4, 6 weeks after
      completion of radiotherapy, and then every 3 months for 1 ear.

      PROJECTED ACCRUAL: A total of 90 participants will be accrued for this study.
    

Intervention name(s): Radiation therapy
Intervention type(s): Radiation
Intervention description(s): Radiation to the whole breast: 43.5 Gy in 15 fractions in 3 weeks. Simultaneous radiation to the surgical cavity: 49.5 Gy in 15 fractions in 3 weeks.
Intensity modulated radiation treatment is used.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypofractionated radiation; breast cancer; breast conserving surgery; simultaneous boost radiation
A Randomized, Placebo-Controlled, Two-Period, Crossover Study to Evaluate the Effect of Lurasidone HCl on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, drug, drug, interaction study between Lurasidone HCl and Ortho-tri cyclen
    


Intervention name(s): Lurasidone 40 mg; Placebo 40 mg; Ortho Tri-Cyclen
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Lurasidone 40 mg days 12-21 once daily; Placebo 40 mg once daily during treatment period; Ortho Tri-Cyclen during 28-day lead in period
Intervention MeSH terms: Moxifloxacin; Lurasidone Hydrochloride; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: OC DDI; lurasidone; Latuda; schizophenia
A Study to Establish the Efficacy of QBX258 in Patients With Moderate to Severe Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to investigate the efficacy and safety of QBX258 in subjects with
      moderate to severe asthma.
    


Intervention name(s): QBX258; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): QBX258 infusion, a combination of VAK694 and QAX576, was supplied to the Investigator as open label bulk medication. The planned dose of VAK694 (lyophilisate in vial, 150 mg/vial), was 3 mg/kg. The planned dose of QAX576 (lyophilisate in vial, 150 mg/vial), was 6 mg/kg.; The placebo infusion was an equal volume of 5% dextrose for infusion and was provided by the clinical site.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Interleukin; QBX258; QAX576; VAK694
A Single and Multiple Dose Study of Dotinurad in Chinese Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate the pharmacokinetics (PK) of dotinurad
      following single and multiple oral doses of dotinurad in Chinese healthy male and female
      participants.
    


Intervention name(s): Dotinurad
Intervention type(s): Drug
Intervention description(s): Dotinurad oral tablet.
Other intervention name(s): FYU-981
Intervention MeSH terms: Dotinurad
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Switching to Iloperidone From Other Antipsychotics in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluate the clinical outcome of two switching strategies to iloperidone treatment in adult
      subjects with schizophrenia who require a change in their current antipsychotic treatment of
      risperidone, olanzapine, or aripiprazole due to suboptimal efficacy and/or
      safety/tolerability reasons.
    


Intervention name(s): iloperidone
Intervention type(s): Drug
Intervention description(s): Iloperidone tablets supplied at doses of 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg to achieve a target dose of 12-24 mg/day for 12 weeks.
Other intervention name(s): Fanapt™
Intervention MeSH terms: Iloperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; iloperidone; switch; gradual switch; immediate switch
Impact of Facemasks on Running During COVID-19 Pandemic
Condition: Shortness of Breath
MeSH terms: COVID-19; Dyspnea
Study type: Interventional

Summary: 
      Randomized crossover clinical trial in which a group of runners are ask to complete a 15
      minutes standardized physical test on a treadmill. The same group of participants are
      randomized to the order in which they use a facemask (surgical mask, polyester reusable cloth
      mask) or no mask, while running.

      Each test, according to the type of mask or no mask, are held on different dates. Heart rate,
      oxygen saturation and shortness of breath are measured every 3 minutes during the test.
    

Detailed description: 
      Between 15-20 recreational runners are included in a crossover trial to run under three
      different conditions the same 15-minutes treadmill running test. They Will run wtih surgical
      mask, polyester reusable cloth mask or without mask. The order in which they use or not the
      mask is randomized. Each test is done on a different day.

      Heart rate, oxygen saturation and shortness of breath are measured every 3 minutes during the
      test.

      The primary outcomes are the differences in heart rate, oxygen saturation and shortness of
      breath at the end of the test, between groups.
    

Intervention name(s): Surgical mask; Polyester reusable mask
Intervention type(s): Other; Other
Intervention description(s): Use of a surgical mask during test; Use of a polyester reusable mask during test
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Oxymetry; Shortness of Breath; Running; Masks; COVID-19
Effectiveness of Continous Adjuvant Lidocaine on General Anaesthesia on Tumor Craniotomy Surgery
Condition: Surgery; Anesthesia; Functional; Haemodynamic Instability
Study type: Interventional

Summary: 
      This study aims to investigate the effect of adjuvant continuous lidocaine in General
      Anesthesia on Depth of Anesthesia (qCON), Pain Response (qNOX), and Blood Sugar Levels in
      Elective Primary Tumor Craniotomy Surgery
    

Detailed description: 
      Craniotomy for resection of brain tumors is frequently performed in neurosurgical practice.
      Craniotomy surgery is currently starting to use the Enhanced Recovery After Surgery (ERAS)
      protocol, namely for intraoperative pain management. Intraoperative pain can be evaluated
      through intraoperative hemodynamic conditions or can also use qCON and qNOX parameters and
      blood sugar levels. Perioperative pain management in the form of continuous intravenous
      lidocaine shows a role in reducing intraoperative pain. However, the use of intravenous
      lidocaine in ERAS protocols is still debated. So this study aims to use general anesthesia
      with continuous IV lidocaine adjuvant general anesthesia to affect depth of anesthesia
      (qCONtm) and intraoperative pain response in the form of values (qNOXtm), and blood sugar
      levels during elective primary tumor craniotomy.

      The method is a Double-Blinded Randomized Control Trial. 60 patients aged 18-65 years who
      were diagnosed with craniotomy supratentorial tumor were randomly allocated to either
      Adjuvant Continuous Lidocaine (intervention group) or Normal Saline 0.9% (control group).
      Both drugs are given in a 20 ml syringe. The primary outcome measure of the study was the
      intraoperative of qCON, qNOX, and Blood Sugar. While the secondary outcome was the
      intraoperative hemodynamic.

      All patients will be induced by general anesthesia using fentanyl 3 μg/kg IV as coinduction
      and propofol 1 mg/kg until the patient falls asleep. After induction, patients who receive
      lidocaine will receive a continuous intravenous infusion of 2 mg/kg/hour of lidocaine while
      other patients are given 0.9% NaCl as control. All patients data of hemodynamics, qCon, QNox,
      and blood glucose recorded and will be analyze.
    

Intervention name(s): NaCl 0.9%; Adjuvant lidocaine continous
Intervention type(s): Drug; Drug
Intervention description(s): NaCl 0.9% continous intravenous on tumor craniotomy surgery; Adjuvant lidocaine continous intravenous on tumor craniotomy surgery
Other intervention name(s): Normal Saline; Lidocaine Intravenous
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Adjuvant Continuous Lidocaine; General Anesthesia; Depth of Anesthesia; Pain Response; Blood Sugar Levels; Elective Primary Tumor Craniotomy Surgery
A Pilot Study of TMS Effects on Pain and Depression in Patients With Fibromyalgia
Condition: Major Depression; Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      In this pilot study, the PI proposes to include 20 African American participants with
      Fibromyalgia to explore the effect of r TMS on pain and depressive symptoms.
    

Detailed description: 
      In this pilot study, the PI proposes to include 20 African American participants with
      Fibromyalgia to explore the effect of r TMS on pain and depressive symptoms. The focus on
      African Americans is due to the mandate from the funding source (internal), as well as
      possible higher prevalence of FM in AA women. If recruitment is slow, the PI proposes to open
      up the study to other groups. Twenty subjects will be randomized to either sham or active TMS
      condition. Inclusion/exclusion criteria are well thought out and seem appropriate.
      mTreatments will be administered at IOP 5 times/wk with each session lasting 20 minutes. Pain
      intensity and unpleasantness will be measured pre and post each TMS session using three
      different pain evaluation paradigms. GCRC resource is mainly requested for two blood draws
      pre and post first TMS session. The blood samples will be used to measure inflammatory
      cytokines IL-1, IL-6, AND IL-8. The main aim is to ascertain feasibility of the study and
      secondary aim is to gather information on variability in response for power analysis for
      future larger study. The introduction and rationale (including pain evaluation, and methods
      relating to TMS) are clearly presented. Use of GCRC resources seem appropriate.
    

Intervention name(s): Active TMS; Sham TMS
Intervention type(s): Device; Device
Intervention description(s): Active TMS uses the active TMS coil to stimulate the cortical area of interest. Active TMS involves 80 trains x 15 sec = 4000 pulses per session, 5 x per week= 20,000 pulses per week, x 2 weeks = 40,000 pulses.; Sham TMS uses the same stimulation frequency as the Active TMS but uses the Sham TMS coil instead to prevent actual stimulation from occurring (chosen as a priori stimulation based on studies showing antidepressant and anti-nociceptive effects): 10 Hertz - Pulse train duration (on time) 5 seconds, Power (intensity) level 120% of stored motor threshold, Inter-train interval (off time) 10 seconds (15 second cycle time). Additionally, stimulation-train duration and inter-stimulus intervals were determined such that they are in compliance with current published rTMS safety guidelines.
Other intervention name(s): Neotonus model 2100 xxx; Neotonus model 2100 xxx
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Major Depression; Fibromyalgia; TMS
Striatal and Extra-striatal Mechanisms of Falling in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      This research study will evaluate functions of memory, thinking, eye movements and walking
      and how these relate to the measurement of certain chemicals (acetylcholine and dopamine) in
      the brain using an imaging procedure called positron emission tomography (PET). You may know
      that the brain chemical dopamine, a "neurotransmitter" substance (a chemical messenger that
      nerve cells need to communicate with each other), is important for the brain to control
      movements and that the brain chemical acetylcholine may have functions related to mental
      concentration and attention. At the present time, the investigators have no clear information
      how these two chemicals in the brain of patients with Parkinson's disease are related to the
      risk of falling.
    

Detailed description: 
      Although most research in PD has a focus on presynaptic dopaminergic denervation, new lessons
      may be learned by exploring to what extent alterations in non-motor and non-dopaminergic
      systems may play a role in the balance impairment in this disorder. This project is designed
      to evaluate striatal pre-synaptic dopaminergic, cortical, thalamic, and brainstem
      cholinergic, cognitive, and oculomotor mechanisms underlying the risk of falling and
      imbalance in PD. The proposed study will exploit advances in our center in the development of
      dynamic biomathematical modeling of electronic platform data, application of specialized
      cognitive and oculomotor assessments, and positron emission tomography (PET). This novel
      multi-system approach holds promise for understanding mechanisms of falling in PD beyond
      pre-synaptic dopaminergic nigrostriatal denervation.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Parkinson's disease and normal control persons between the ages of 50-85
        years are eligible to participate in this study. Participants should be willing and able to
        comply with study requirements. Normal control persons should not have a history of brain
        or mental disorders. Both males and females are eligible.
Cognitive Behavioral Smoking Cessation Intervention for Adults With Chronic Pain
Condition: Smoking Cessation
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      Millions of individuals with chronic pain smoke and our preliminary research suggests that
      currently available strategies to help people quit smoking may not be effective for
      individuals with chronic pain. This is important in that smokers with chronic pain have worse
      pain-related health outcomes compared to nonsmokers with chronic pain. The primary aim of
      this research project is to develop a smoking cessation intervention for specific use in an
      outpatient clinical setting for smokers with chronic pain.
    


Intervention name(s): Cognitive behavioral; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Cognitive behavioral intervention for smoking cessation; Treatment as usual
Other intervention name(s): Cognitive; Behavioral; Smoking Cessation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Smoking cessation; Nicotine dependence; Chronic pain
Racial Differences in Orthostatic Tolerance
Condition: Orthostatic Tolerance
Study type: Observational

Summary: 
      Our central hypothesis is that baroreflex sensitivity is attenuated in black women compared
      to white women, and that this dysregulation will be apparent during orthostatic challenges.
      We expect that the cumulative stress index (CSI), a measure of maximal orthostatic tolerance,
      is higher in Black women (BW) compared to White women (WW).
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Community sample of women of reproductive age
      
Biospecimen description: 
      whole blood
Prospective Multicenter Non-interventional Study in Patients With Knee or Hip Osteoarthritis Having a Theraflex Treatment
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Hip
Study type: Observational

Summary: 
      The main purpose of this study is to evaluate how a long-term treatment with Theraflex during
      64 weeks affects pain intensity in the affected knee or hip joint, the activity in daily
      living, the quality of life and patient satisfaction with treatment.
    

Detailed description: 
      Other information that is planned for evaluation in this study includes consumption of
      Theraflex, intake of analgesics for joint pain relief and description of basic patient
      characteristics such as age, weight and body mass index and others.
    

Intervention name(s): Theraflex, BAY 874017
Intervention type(s): Drug
Intervention description(s): The first three weeks which do have a different posology (3 capsules a day) according to the label should be entered as a distinct period to the treatment period with a recommended posology of 2 capsules a day
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient who will be made aware about the study either by the treating physician OR by a
        pharmacist where a patient is purchasing Theraflex