bioihbjkbjnl/mcl2 huggingface dataset:
Ultrasound Guided Ankle Block Versus Medial Forefoot Block for Forefoot Surgery
Condition: Pain Relief After Forefoot Surgery
Study type: Interventional

Summary: 
      Forefoot surgery includes bunion surgery and similar reconstructive bone cutting surgery and
      is very painful. Local anaesthetic nerve blocks have been used for many years to help
      alleviate pain following this surgery. The present study aims to compare a new ultrasound
      guided nerve block to a well established nerve stimulator guided technique. Comparisons will
      include time taken to carry out the block, speed of onset of numbness and duration and
      quality of pain relief after surgery.
    


Intervention name(s): Ultrasound guided ankle block; Medial forefoot block
Intervention type(s): Procedure; Procedure
Intervention description(s): Under ultrasound guidance, block of the tibial nerve, superficial and deep branches of the common peroneal nerve and saphenous nerves will be carried out using 12 mls 0.5% levobupivacaine and 12 mls 0.75% levobupivacaine.; Using peripheral nerve stimulator guidance, the tibial and common peroneal nerves will be blocked ( plus the saphenous nerve ), using a total of 12 mls 0.75% levobupivacaine and 12 mls 0.5% levobupivacaine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: anaesthetic techniques, regional; surgery orthopaedic
Reducing the Effects of Aging on Cognition With Therapeutic Intervention of an Oral Nutrient (REACTION): A Pilot Trial
Condition: Cognitive Decline
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research is to assess the feasibility (e.g., recruitment rate, adherence
      rate and retention rate) of a clinical trial using virtual assessments to investigate the
      effect of a 6-month administration of a specific multi-nutrient oral supplement on cognitive
      aging.

      The study will also test whether a 6-month daily intake of a specific multinutrient can delay
      or reverse the effects of normal cognitive aging on other cognition domains as well as
      quality of life as measured by virtual assessments.
    

Detailed description: 
      Participants with cognitive aging who meet the eligibility criteria are provided study
      information and scheduled for a screening visit via virtual encounter. At the screening
      visit, participants meeting criteria are enrolled, and a baseline visit is scheduled (same
      day, or separately.) The participants are then randomized to either the test product
      (specific multi-nutrient) or placebo. Study parameters will be assessed at baseline, and 6
      months via a virtual online platform. Patients will be contacted monthly via telephone to
      promote compliance and monitor progress. An optional sample of blood may be provided by the
      participant if willing to participated in this optional sub-study.
    

Intervention name(s): Souvenaid; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Souvenaid is an oral beverage that contains a vitamin mixture (Vitamin A, B1, B2, B3, B5, D) plus three main active ingredients: omega-3 fatty acids, uridine monophosphate, and choline.; The Placebo used in this study is an oral beverage vitamin mixture containing Vitamins A, B1, B2, B3 and B5.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Memory; Cognitive Aging
Assessing the Safety, Tolerability and Pharmacokinetics(PK) of DZD9008 and the Effect of Low-fat Meal on PK of DZD9008 in Healthy Adult Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomised, double-blind, placebo-controlled, single ascending dose
      sequential group study in healthy participants. This study consists of three parts: Part A
      (single dose escalation, SAD) , Part B (food effect, FE) and Part C (relative
      bioavailability, BA).
    


Intervention name(s): DZD9008; Placebo; DZD9008; DZD9008
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): In the double blind, randomised, placebo-controlled trial (Part A - SAD), healthy adult participants will be randomized to receive DZD9008 at different dose levels. There are 5 planned dose cohorts, starting from 50 mg once daily. If tolerated, subsequent cohorts will test increasing doses of DZD9008 or matching placebo, namely 100 mg, 200 mg, 300 mg and 400 mg.; In the double blind, randomised, placebo-controlled trial (Part A - SAD), healthy adult participants will be randomized to receive matching placebo for DZD9008 at different dose levels. There are 5 planned dose cohorts of matching placebo for DZD9008, starting from 50 mg once daily.; In Part C, healthy adult participants will be enrolled to receive a single dose of DZD9008 as suspension in period 1 and as tablet in period 2.; Healthy adult participants will be randomized to receive DZD9008 single dose at a defined dose under a cross-over condition with or without food (low-fat in Part B; high-fat in Part D).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Glutamine Popsicles in Bone Marrow Transplant (BMT)/Hematopoietic Stem Cell Transplant (HSCT) Patients
Condition: Bone Marrow Transplantation; Hematopoietic Stem Cell Transplantion
Study type: Interventional
Phase: Phase 4

Summary: 
      Nutrition is an important part of the recovery process after having a head injury so that
      subjects can gain strength and fight off infection. Liquid nutrition formulas are often given
      to patients through a tube that has been placed into the intestines for feeding when they are
      unable to eat on their own. Some reports suggest that nutrition with extra amounts of the
      amino acid called glutamine may decrease infections and hospital stay in severely injured
      patients. The purpose of this study is to evaluate if giving extra amounts of an amino acid
      called glutamine with liquid nutrition formulas will decrease the risk of infection and
      length of stay in the intensive care unit after having a head injury.
    


Intervention name(s): nutritional supplement; glutamine popsicle
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Prevention
Keywords: bone marrow transplant (BMT); hematopoietic stem cell transplant (HSCT)
Study Of Single Doses Of PF-06291826 (Tafamidis) In Japanese And Western Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is the following:

        -  To evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered
           tafamidis in Japanese and Western healthy volunteers at single dose.

        -  To compare Japanese and Western PK profiles.

        -  Determine the PD stabilization effect of tafamidis on human transthyretin (TTR) in a
           validated ex vivo assay.
    


Intervention name(s): Tafamidis meglumin; Tafamidis meglumin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single oral dose of 20 mg capsule; A single oral dose of 40 mg capsule.; A single oral dose of matched placebo.
Other intervention name(s): PF-06291826; PF-06291826
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Tafamidis; Pharmacokinetics; TTR stabilization
Magnetic Resonance Imaging Study of Geriatric Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The purpose of this study was to use Magnetic Resonance Images to further our understanding
      of predictors and markers of treatment response and non-response in geriatric depression. We
      hypothesized that concentrations of high energy metabolites would be lower in depressed
      elderly compared to non-depressed.
    


Intervention name(s): Sertraline
Intervention type(s): Drug
Intervention description(s): Oral Sertraline Dosage started at 25 mg a day, with increases up to maximum dosage strength of 200 mg a day.
Duration of treatment was 12 weeks.
Other intervention name(s): Zoloft
Intervention MeSH terms: Sertraline
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; Geriatric; MRI; Sertraline
PharmacofMRI (Functional Magnetic Resonance Imaging) of Anxiolytic Medications (Alprazolam)
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to use functional magnetic resonance imaging (fMRI) in healthy
      controls to examine the acute effects of certain anxiolytic medications on brain function.
    

Detailed description: 
      Increased amygdala and insula activity have been implicated in neurobiological models of
      anxiety. Using fMRI, the anxiolytic medication, lorazepam, has previously been found to
      decrease activation in these areas during the processing of emotional stimuli. This study
      aims to replicate those results but by using a different medication, alprazolam. An eventual
      aim of this study, in combination with future studies, is to evaluate the utility of fMRI as
      a tool to identify anxiolytic function in both established and novel compounds that may be
      used to treat anxiety.
    

Intervention name(s): 0.25 mg alprazolam; 1.0 mg alprazolam; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.25 mg alprazolam PO (liquid) to be administered 1 hour prior to fMRI scan
Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart.; 1 mg alprazolam PO (liquid) will be administered 1 hour prior to fMRI scan
Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart.; Placebo (liquid) to be administered 1 hour prior to fMRI scan
Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart.
Other intervention name(s): Xanax; Xanax
Intervention MeSH terms: Alprazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: functional magnetic resonance imaging; fMRI; alprazolam; anxiety disorders
Evaluation of Effectiveness of Acetylsalicylic Acid on Markers of Vascular Dysfunction in Scleroderma Patients
Condition: Systemic Sclerosis
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Systemic sclerosis is a chronic autoimmune disease characterized by vascular changes in the
      microcirculation (small blood vessels) and progressive fibrosis of the skin and internal
      organs. It is believed that vascular changes, expressed early by the Raynaud phenomenon,
      precede fibrosis and organic dysfunction. There is no available treatment that reverses the
      vascular damage caused by the disease to the moment, although there are several medications
      recommended for the relief of manifestations due to vascular injury. Acetylsalicylic acid
      (ASA) is one of the medications that can be used for the treatment of vascular injury present
      in systemic sclerosis, but still without a fully proven benefit. This study aims to evaluate
      the effectiveness of ASA on microcirculation alterations in patients with systemic sclerosis
      by performing three exams: periungual panoramic capillary microscopy, videocapillaroscopy and
      laser Doppler imaging. In addition, a blood sample will be collected for dosing the following
      vascular lesion markers: endothelin-1, von Willebrand factor, thromboxane, and
      platelet-derived, endothelial-derived and monocyte-derived microparticles.
    


Intervention name(s): Acetylsalicylic acid; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Patients will be randomized to take one pill of either acetylsalicylic acid or placebo once daily for 4 weeks; Patients will be randomized to take one pill of either acetylsalicylic acid or placebo once daily for 4 weeks
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Systemic sclerosis; Acetylsalicylic acid; Vascular dysfunction
Phase I Clinical Trial of a COVID-19 Vaccine in 18-60 Healthy Adults
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      The 2019 novel-coronavirus (2019-nCov) is the cause of a cluster of unexplained pneumonia
      that started in Hubei province in China. It has manifest into a global health crisis with
      escalating confirmed cases and spread across many countries.

      In view of the fact that there is currently no effective antiviral therapy, the prevention or
      treatment of diseases caused by COVID-19 can be tough for current treatment.

      This study is a phase I clinical trial. The investigators intent to evaluate the safety,
      reactogenicity and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5
      Vector) .
    

Detailed description: 
      This is a single-center,open-label，dose-escalating phase I clinical trial in healthy 18 to 60
      years of age, inclusive, who are in good health and meet all eligibility criteria. This
      clinical trial is designed to assess the safety, reactogenicity and immunogenicity of
      Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) manufactured by Beijing
      Institute of Biotechnology and CanSino Biologics Inc.One hundred and eight subjects will be
      enrolled into one of three cohorts and will receive an intramuscular (IM) injection of
      experimental vaccine or placebo on Days 1 in the deltoid muscle.
    

Intervention name(s): Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intervention type(s): Biological
Intervention description(s): Intramuscular other name:Ad5-nCoV
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: COVID-19; vaccine; Ad5; Safety; Immunogenicity; Infection; novel coronavirus; Dose-escalation
Target Temperature Management In Myocardial Infarction - A Pilot Study
Condition: ST-elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      The primary goal in the treatment of acute myocardial infarction is to reperfuse the ischemic
      myocardium to reduce infarct size. Animal data and human data suggest that whole-body cooling
      to temperatures below 35°C before revascularisation can additionally reduce infarct size and
      therefore improves outcome in these patients.

      The purpose of the study is to determine the feasibility and safety of a combined cooling
      strategy started in the out-of-hospital arena for achieving pre-reperfusion hypothermia in
      patients with acute st-elevation myocardial infarction.
    


Intervention name(s): EMCOOLS flex pad; Philips Innercool RTx
Intervention type(s): Device
Intervention description(s): Surface cooling with EMCOOLS flex pads (out-of-hospital); Infusion of 1000ml to 2000ml of cold saline (out-of-hospital); central-venous cooling (Philips Innercool RTx)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Myocardial Infarction; Myocardial Reperfusion Injury; Reperfusion Injury; Anterior Wall Myocardial Infarction; Inferior Wall Myocardial Infarction; Myocardial Ischemia
A Study to Compare QUTENZA With Pregabalin for the Treatment of Peripheral Neuropathic Pain (PNP) After 8 Weeks of Treatment
Condition: Non-diabetic Painful Peripheral Polyneuropathy; Postherpetic Neuralgia (PHN); Peripheral Nerve Injury (PNI)
MeSH terms: Neuralgia; Polyneuropathies; Neuralgia, Postherpetic; Peripheral Nerve Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is comparing the efficacy and tolerability of Qutenza with that of pregabalin in
      patients suffering from peripheral neuropathic pain. Treatment allocation will be to one of
      these treatments and the duration of the study will be about 10 weeks (assuming that from
      screening to treatment allocation takes 2 weeks). Participants will be asked to complete
      questionnaires about various aspects relating to their condition throughout the study.

      This study will include subjects suffering from Postherpetic Neuralgia, Peripheral Nerve
      Injury or Non Diabetic peripheral polyneuropathy.
    


Intervention name(s): Qutenza; Pregabalin
Intervention type(s): Drug; Drug
Intervention description(s): Cutaneous patch; Oral capsule
Other intervention name(s): Capsaicin
Intervention MeSH terms: Pregabalin; Capsaicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Post herpetic neuralgia; Qutenza; NGX-4010; Peripheral Neuropathic Pain; Pregabalin
Switching Study of Kidney Transplant Patients With Tremor to LCP-Tacro (STRATO)
Condition: Renal Failure; Tremors
MeSH terms: Tremor
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate and measure symptomatic hand tremor in stable kidney transplant
      subjects on Prograf or generic tacrolimus maintenance therapy at baseline (pre-conversion)
      and following conversion to LCP-Tacro. This study will also evaluate the safety of LCP-Tacro
      compared with Prograf or generic tacrolimus
    

Detailed description: 
      This is a 2 sequence, open-label, multicenter, prospective Phase 3b clinical study to access
      drug-induced hand tremors in stable kidney transplant subjects converted from Prograf
      (tacro-limus, Astellas Pharma US, Inc., Deerfield, IL) or generic tacrolimus twice daily
      (b.i.d.) to LCP-Tacro tablets (tacrolimus, Veloxis Pharmaceuticals A/S, Horsholm, Denmark)
      once daily (q.d.). The trial is designed to determine if the test drug LCP-Tacro, is
      associated with fewer and/or less severe drug-induced hand tremor than observed with Prograf
      or generic tacrolimus treatment; each therapy is to be concomitantly administered with
      mycophenolate mofetil (MMF), mycophenolate sodium (MPS), including generic versions of each,
      and/or prednisone or equivalent as long as doses remain stable during the study. All
      prophylaxis and other medication will be allowed per standard of care (SOC) in each of the
      participating sites; no medication that interacts with the pharmacokinetics (PK) of
      tacrolimus is allowed unless subjects who are recipients of a renal transplant at least 1
      month and not more than 5 years prior to enrollment. Following screening, study visits will
      be conducted over a 2-week treatment period with consists of 1 week of Prograf or generic
      tacrolimus SOC, and 1 week of LCP-Tacro. Subjects who qualify for extended use of LCP-Tacro
      can continue LCP-Tacro treatment for additional 2 years. This decision will be made at the
      discretion of the physician and subject.
    

Intervention name(s): Prograf; LCP-Tacro
Intervention type(s): Drug; Drug
Intervention description(s): Oral Prograf or generic tacrolimus doses will be taken b,i,d, consistently in 2 divided doses, once in the morning and once in the evening, to maintain trough level in the range of 3 to 12 ng/mL. Target trough level for the subject will be determined per clinical practice.; LCP-Tacro will be administered orally q.d. in the morning based on a conversion factor from Prograf or generic tacrolimus to LCP-Tacro of 0.7 for non-African American subjects and 0.85 for African American subjects to maintain target trough level of 3 to 12 ng/mL.
Other intervention name(s): tacrolimus; tacrolimus
Intervention MeSH terms: Tacrolimus
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pulmonary Hypertension, Hypoxia and Sickle Cell Disease
Condition: Chuvash Polycythemia; Cerebrovascular Disease; Pulmonary Hypertension; Sickle Cell Anemia
MeSH terms: Hypertension, Pulmonary; Cerebrovascular Disorders; Hypertension; Anemia, Sickle Cell; Polycythemia
Study type: Observational

Summary: 
      The study will look at the risk factors for pulmonary hypertension (high blood pressure in
      the lungs) in children and adolescents with sickle cell anemia (SCA) and examine the role of
      hypoxia (oxygen shortage) in the disease. In patients with SCA, red blood cells become
      sickle-shaped and tend to form clumps that get stuck in blood vessels, blocking blood flow to
      the limbs and organs. Blocked blood vessels can cause pain, serious infections, and organ
      damage. Many patients with SCA also develop pulmonary hypertension.

      Children and adolescents with SCA or Chuvash polycythemia (another blood disorder that
      carries an increased risk for pulmonary hypertension) may be eligible for this study.

      Participants undergo the following procedures at the beginning (baseline) and end of the
      study:

        -  History, physical examination and blood tests .

        -  Echocardiography (ultrasound study of heart function).

        -  Transcranial doppler (brain ultrasound study to measure brain blood flow).

        -  Lung function tests.

        -  6-minute walk (measure of the distance covered in 6 minutes of walking).

      In addition, patients are followed by telephone or by clinic visits every 6 months for a
      review of their medical history and medications. A physical examination is also done at 12
      months.
    

Detailed description: 
      The research is designed to determine the prevalence and risk factors of pulmonary
      hypertension (PHT) in children and adolescents with sickle cell disease (SCD), and to
      determine the role of the hypoxic response in its pathogenesis. In this regard, proliferative
      vascular responses mediated by (i) hypoxia inducible factor (HIF)-regulated pathways and (ii)
      nitric oxide (NO)-scavenging will be compared between patients with SCD and patients with
      Chuvash polycythemia (CP), another hematological disorder characterized by increased risk for
      PHT. High throughput microarray and genotyping technologies will be employed to identify
      candidate gene pholymorphisms involved in pathologic responses to hypoxia in SCD and CP
      patients with and without PHT.
    

Time perspective: Other
Keywords: 6-Minute Walk; Chuvash Polycythemia; Echocardiogram; Sickle Cell Anemia; Pulmonary Function Tests; Sickle Cell Disease; SCD; Pulmonary Hypertension
BRAVE: Building Resilience and Values Through E-health
Condition: Survivorship
Study type: Interventional

Summary: 
      The purpose of this study is to determine the feasibility and acceptability of tracking
      survivors' and their caregivers, stressors, affect, and symptoms using an electronic diary
      method, in the time period surrounding their routine check- up with their oncologist.
    


Intervention name(s): Online survey questionnaire
Intervention type(s): Other
Intervention description(s): Participants will complete a brief online survey every morning and evening within 1 hour of waking and 1 hour of going to sleep. The surveys will be a combination of measures used to assess affect, stress, and symptoms
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care