bioihbjkbjnl/mcl2 huggingface dataset:
Genetics of Cardiovascular Reactivity in Black Youth
Condition: Cardiovascular Diseases; Heart Diseases; Hypertension
MeSH terms: Cardiovascular Diseases; Heart Diseases
Study type: Observational

Summary: 
      To evaluate individual differences in cardiovascular responses to acute stress in Black
      adolescents.
    

Detailed description: 
      BACKGROUND:

      The prevalence and severity of essential hypertension (EH) are greater among Black Americans
      than other ethnic groups in the U.S. Blacks are at increased risk for target organ damage
      from elevated blood pressure, including heart disease, stroke, and endstage renal failure.
      There are significant ethnic differences in cardiovascular reactivity (CVR) to stress, which
      is a risk factor for elevated blood pressure. Studies have shown that CVR to stress is stable
      over time, heritable, and predictive of future elevations in blood pressure and the
      development of essential hypertension. These properties make measures of CVR a valuable
      intermediate for genetic studies of hypertensive risk.

      DESIGN NARRATIVE:

      The genetic epidemiology study will test the hypothesis that individual differences in CVR to
      acute stress in Black youth are associated with well defined polymorphisms in candidate genes
      related to blood pressure including: 1) alpha- and beta-adrenergic receptor genes; 2) genes
      involved in catecholamine metabolism; 3) genes involved in endocrine function; 4) genes
      involved in the renin angiotensin system. By focusing on normotensive youth at risk for
      developing essential hypertension, the investigators hope to identify genes associated with
      the onset, rather than the sequelae, of hypertension. Moreover, given that CVR to acute
      stress is defined as a change in cardiovascular function evoked by an environmental
      manipulation of stress, the research is inherently a study of gene-environment interactions.

      A total of 500 unrelated Black adolescents and young adults (equal numbers of males and
      females), 15-21 years of age will be studied. Buccal cell samples will be collected for DNA
      extraction from all subjects for genetic association analyses. Impedance cardiography and
      blood pressure monitoring will be used to assess components of CVR to stress during video
      game, mental arithmetic, cold pressor, and whole body cold exposure tasks, all of which have
      been utilized or developed in the laboratory. Various methods will be used to evaluate
      genetic associations with CVR to acute stress, including analyses of single nucleotide
      polymorphisms and haplotypes. Supplementary analyses will evaluate potential gene-gene
      interactions and additional gene-environment interactions involving chronic environmental
      stress.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        500 African American youth
      
Biospecimen description: 
      buccal specimens stored at Med Coll Wisconsin
Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan Dose Response Clinical Trial
Condition: Central Neuropathic Pain; Allodynia; Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Neuralgia; Hyperalgesia; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomized, placebo-controlled, double-blind 4x4 crossover clinical trial was part of a
      larger NIH-funded study to evaluate the analgesic efficacy of three doses of chronic oral
      (PO) dextromethorphan compared to placebo in central neuropathic pain following spinal cord
      injury. Subjects' maximally tolerated doses (MTD) were first determined to establish
      individual dose-analgesic response relationships in a run-in period; following a washout
      period, subjects were then randomized to receive an order of four doses of dextromethorphan
      (including placebo) in a 4x4 Latin square cross-over design.
    


Intervention name(s): Dextromethorphan
Intervention type(s): Drug
Intervention description(s): 0, 25, 50 and 100% of maximum tolerated dose, each administered over a 4 week period
Intervention MeSH terms: Dextromethorphan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic pain; central neuropathic pain; spinal cord injury; dextromethorphan; lidocaine; combination therapy; analgesia
High Dose Nimodipine Treatment Adjunct - 1
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if nimodipine is more effective than placebo in
      reducing stimulated craving for cocaine in cocaine dependent individuals denied access to
      cocaine in inpatient unit.
    


Intervention name(s): Nimodipine
Intervention type(s): Drug
Intervention MeSH terms: Nimodipine
Primary purpose: Treatment
An Explorative Study To Develop A Predictive Model Based On Avascular Exposed Root Surface Area For Root Coverage
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Observational

Summary: 
      The aim of this study was to evaluate the reliability of the avascular root surface area as a
      prognostic identification criterion for gingival recessions and to compare the predictive
      value of the Miller classification and avascular root surface area (AERSA) calculation on the
      final root coverage outcomes.
    


Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Ninety one patients, 41 females and 50 males, aged between 21-41 years, with 91 isolated
        single gingival recessions (32 Miller I, 29 Miller II, 30 Miller III defects) located at
        upper and lower incisors and canines.
Feeding Tube Practices and Colonization of the Preterm Stomach in the First Week of Life
Condition: Preterm Birth
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Project summary

      Rationale

      Many NICU's replace their feeding tubes once a week or more rarely in order to avoid
      disturbing the infants. The researchers discovered that there are high concentrations of
      potentially pathogenic bacteria in the yield of resident nasogastric feeding tubes, even
      within one day of use (own data, manuscript submitted). Preterm infants are vulnerable to the
      colonization of the gut, and development of dysbiosis might lead to necrotizing
      enterocolitis. The researchers speculate if replacing the resident feeding tube every day and
      thereby decreasing the amount of potentially pathogenic bacteria given to the infants via the
      feeding tube will lead to fewer bacteria present in the upper part of the gastrointestinal
      tract of the infant and hence a reduced competition with probiotic colonization.

      Objectives

      The investigators plan to conduct an intervention study in premature infants receiving
      probiotics (< 32 weeks of gestation) where the feeding tube will be replaced every day in the
      intervention group and once a week (standard practice) in the control group. The main outcome
      will be bacterial concentration in the stomach after one week of life.

      Methods

      The study is a prospective, randomized controlled trial in preterm infants. Infants will be
      randomized to the intervention group in which the tube is replaced every day or the control
      group which will follow normal practice in the department. The intervention will last one
      week. The infants will be followed until discharge. The investigators plan to include 11
      infants in each group.

      Primary outcome

      Concentration of bacteria in gastric aspirates on day seven.
    


Intervention name(s): Feeding tube daily replacement
Intervention type(s): Procedure
Intervention description(s): Feeding tubes replaced once a day in the first week of life.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Observation Study of the Pharmacokinetics of Adductor Canal Block
Condition: Toxicity, Drug
MeSH terms: Drug-Related Side Effects and Adverse Reactions
Study type: Observational

Summary: 
      With the aging of the population, osteoarthritis of knees and hips become major orthopedic
      problems worldwide. Osteoarthritis of the knees and hips is associated with a significant
      pain problem and functional disability. Total joints replacement is the ultimate surgical
      procedure to deal with such problems. Multimodal analgesia, including periarticular local
      infiltration of analgesia (LIA), regional nerve block using adductor canal block (ACB),
      opioid and non-opioid have been shown to be effective in managing postoperative pain.
      Regional nerve block using femoral nerve block or adductor canal block (ACB) is also a
      well-established analgesic technique after total knee replacement. Standard bupivacaine (SB),
      levobupivacaine, ropivacaine were used in ACB in these studies. Whether combining ACB with
      periarticular LIA has the additional benefit of prolonging analgesia or with synergistic
      effect remains controversial, because the number of RCTs conducted is not enough. Liposomal
      bupivacaine (LB) may further prolong the analgesic effect of ACB, as the therapeutic levels
      of bupivacaine are below the toxic range and sustained for 72 hours after injection. The
      purpose of this study is to evaluate the safety and systemic levels of serum bupivacaine
      following adductor canal block using LB 66.5mg in patients undergoing TKA with LIA over a
      72-hour period. This also serves as a pilot study to determine the dose and timing of blood
      taking for serum bupivacaine level of a previously IRB approved study - "Comparing the
      efficacy of combining periarticular local infiltration of analgesia and adductor canal block
      using liposomal bupivacaine and standard bupivacaine- A prospective randomized controlled
      trial".
    

Detailed description: 
      After signing the consent form, participants will receive LIA with ACB using 5ml of 1.33%
      liposomal bupivacaine with 5ml of 0.9% normal saline.

      Participants will receive routine preoperative, intraoperative, and postoperative treatments
      like other patients undergoing total knee replacement.

      Blood will be collected during induction, at 1 hour, 2 hours, 4 hours, 8 hours, and 12 hours
      after the performance of ACB through a designated 14-gauge cannula, and also at 24, 48, and
      72 hours after the operation during routine blood taking.
    

Intervention name(s): Liposomal bupivacaine
Intervention type(s): Drug
Intervention description(s): 5ml of 1.33% liposomal bupivacaine with 5 ml of 0.9% normal saline will be given to treatment group.
Intervention MeSH terms: Bupivacaine
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients admitted for elective primary unilateral total knee replacement in Queen Mary
        Hospital.
Cognitive Behavioral Therapy for Insomnia vs. Exposure, Relaxation, and Rescripting Therapy
Condition: Insomnia; Nightmare; Trauma
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      The objective of this project is to determine if directly addressing disturbed sleep and
      nightmares will impact client reports of suicidal ideation.
    


Intervention name(s): CBT-I; ERRT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Targeting insomnia symptoms to reduce suicidal ideation and sleep problems related to traumatic experience.; Targeting post-trauma nightmares to reduce suicidal ideation and sleep problems related to traumatic experience.
Other intervention name(s): Cognitive Behavioral Therapy for Insomnia; Exposure, Relaxation, Rescripting Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Therapeutic Effects of LED (627 +/- 10nm) The Initial Phase of the Ankle Sprains Treatment
Condition: Ankle Sprain
MeSH terms: Sprains and Strains; Ankle Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the therapeutic effects of the LED (627 +/- 10 nm)
      with respect to the localized pain and local swelling of ankle sprains in the initial phase.
    

Detailed description: 
      A variety of therapies for the treatment of sprains has emerged as they occur advances in
      technological applications. Therapy with coherent and non-coherent light is a treatment
      modality for a variety of musculoskeletal injuries. The main benefits certificates for
      phototherapy are the reduction of nociceptive processes, tissue remodeling, among others. The
      aim of the present paper is to analyze the changes caused by the use of LED (627 +/- 10 nm)
      with an energy density of 10 J / cm2 in 40 subjects divided into two groups (placebo and
      LED). All volunteers participating in this study had ankle inversion sprain grade II treated
      with the price technique. The study was performed in six days. And the results were verified
      by review of all individuals, through the Visual Analogue Scale (VAS) of pain, McGill Pain
      Questionnaire and Titrimetry. Measurements were performed at first, third and sixth day's of
      treatment.
    

Intervention name(s): Grupo LED; Placebo
Intervention type(s): Other; Other
Intervention description(s): ledterapia off + price
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: laser; LED; PRICE; pain; edema
Efficacy Trial for the Reduction of Glabellar Lines
Condition: Rhytids in the Glabellar Region
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the ability of the Serene RF System to effectively
      improve the appearance of dynamic glabellar lines and sustain the effect for a minimum of 3
      months.
    


Intervention name(s): Serene RF System
Intervention type(s): Device
Intervention description(s): The Serene RF System provides percutaneous delivery of radiofrequency (RF) energy to a targeted nerve.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult men and women with moderate to severe glabellar lines
Bone Marrow-Derived Stem Cell Transfer in Acute Myocardial Infarctions
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      The benefit of reperfusion therapies for ST-elevation acute myocardial infarction (STEMI) is
      limited by postinfarction left ventricular (LV) dysfunction.The purpose of this study is to
      determine whether intracoronary transfer of bone marrow cells will augment left ventricular
      function recovery of the heart.
    

Detailed description: 
      Despite early coronary reperfusion, salvage of ischemic myocardium is incomplete and loss of
      viable myocardium initiates a process of adverse left ventricular (LV) remodeling1,
      compromising clinical outcome.

      Experimental data have suggested that autologous bone marrow-derived or circulating
      progenitor cells may be beneficial for LV function recovery, but underlying mechanisms are
      unclear and prominent cardiomyocyte transdifferentiation has only been reported under
      selected experimental conditions. Early non-randomized clinical investigations indicate
      feasibility, safety and enhanced functional recovery after autologous human bone
      marrow-derived stem cell (BMSC) infusion into the infarct-related artery. More recently, a
      randomized open study demonstrated improvement of LV systolic function but not of LV
      remodeling following BMSC transfer.

      In the absence of trials, in which the control group reproduces the exact conditions of the
      cell transfer group, including bone marrow aspiration and a placebo intracoronary injection,
      the true benefit of cell transfer cannot be fully appreciated.

      We, therefore, designed a randomized, double-blind, and placebo-controlled exploratory study
      to investigate the effect of autologous BMSC transfer on LV functional and structural
      recovery after myocardial infarction. In view of the exploratory nature of the study and to
      detect potential mechanisms for the biological effect, we also assessed myocardial perfusion
      and oxidative metabolism using serial 1-[11C]acetate positron emission tomography (PET).
    

Intervention name(s): bone marrow-derived stem cell transfer
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Keywords: bone marrow cell transfer; acute myocardial infarction; left ventricular function
Ologen® Collagen Matrix Versus Mitomycin-C in Patients With Juvenile-onset Open Angle Glaucoma
Condition: Open Angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Study type: Interventional

Summary: 
      To the best of Investigator knowledge, no studies to this date have compared the safety and
      efficacyof ologen® Collagen Matrix to MMC in exaggerated healing response among JOAG
      patients. Given that,filtration surgery is usually less successful in patients with juvenile
      glaucoma; the purpose of this study is to compare these two adjuvant therapies in exaggerated
      healing response among JOAG patients. Investigator hypothesis is that trabeculectomy with
      ologen® Collagen Matrix would be as effective as MMC in IOP control, with prominent bleb
      morphology as compared to MMC bleb.
    

Detailed description: 
      Standard trabeculectomy All trabeculectomy surgeries will be performed under peribulbar
      anesthesia.Under aseptic surgical technique, superior rectus suture will be placed using 4-0
      silk and a fornix-based conjunctival flap will be performed. Sub-Tenon dissection and
      hemostasis may be performed as required.A half-thickness 4 x 4mm rectangular/ triangular
      scleral flap will be dissected up to clear cornea, and a 2 × 2 mm deep scleral block will be
      excised and peripheral iridectomy will be performed. The scleral flap will be closed with one
      or two 10-0 nylon sutures and conjunctiva will be closed with 8-0 vicryl suture. Releasable
      sutures may be applied to the scleral flap if needed.

      ologen® Collagen Matrix ologen® Collagen Matrix approved by Indian health authority with
      registration numberof MD-1517 (valid till Mar-15-2018) will be provided by Aeon Ajanta India
      Pvt. Ltd. free of cost for this clinical research only.

      The following table summarizes the model number, shape and manufacturer of ologen® Collagen
      Matrix to be used in this clinical research.

      Product Model Shape Size Manufacturer Country of Origin Product Registration ologen® Collagen
      Matrix 830601 Round cylindrical 6mm (diameter) x 2mm (thickness) Aeon Astron Europe B. V. The
      Netherlands MD-1517 (valid till Mar-15-2018)

      Mitomycin C Mitomycin-C Kyowa®; Kyowa Hakko Kogyo Co., Ltd. will be used. 0.02% solution of
      MMC will be prepared freshly on the day of planned surgery.
    

Intervention name(s): ologen® Collagen Matrix; Trabeculectomy with low dose mitomycin C
Intervention type(s): Procedure; Procedure
Intervention description(s): Ologen is a collagen matrix used to modulate wound healing in the postoperative period to promote diffuse blebs; Trabeculectomy with low dose MMC
Intervention MeSH terms: Mitomycins; Mitomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: ologen® Collagen Matrix, Model 830601, shape Round cylindrical, Size 6mm (diameter) x 2mm (thickness),Manufacturer Aeon Astron Europe B. V.
Masking: None (Open Label)
Primary purpose: Treatment
Inactivated Poliomyelitis Vaccine Made From Sabin Strain
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study includes both active and passive safety monitoring in large pupulations for the
      phase IV safety monitoring study of Inactivated Poliomyelitis Vaccine Made From Sabin Strain
      (sIPV).
    

Detailed description: 
      For active safety monitoring in expanding populations, a total of 20,019 participants in
      Shanghai CDC have been enrolled in accordance with GCP for close safety monitoring for
      immediate adverse events and telephone or visiting follow-up (30 min, 24h, 3d, 7d, 14d, 30d)
      For passive safety monitoring in larger populations, the purpose is to observe rare adverse
      events after primary and booster immunization with sIPV by passive safety surveillance via
      AEFI monitoring system in Shanghai CDC. A total of 29,712 infants have been enrolled, and the
      adverse events of the participates have been collected via AEFI monitoring system and
      evaluated after 3-dose sIPV for primary immunization.
    

Intervention name(s): Inactivated Poliomyelitis Vaccine Made From Sabin Strain
Intervention type(s): Biological
Intervention description(s): Type I D antigen 30DU;Type II D antigen 32DU;Type III D antigen 45 DU
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Glycaemic, Insulinaemic and Appetite Responses to Two Different Types of Porridge
Condition: Postprandial Glycaemia,; Postprandial Insulinaemia; Appetite
Study type: Interventional

Summary: 
      The purpose of this study is to assess the postprandial glycaemic, insulinaemic and appetite
      responses to porridge made with oats processed differently.
    


Intervention name(s): Test meal
Intervention type(s): Drug
Intervention description(s): Porridge made from rolled, or pinhead oats providing 50 g of carbohydrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Evaluation of Liposomal Curcumin in Healthy Volunteers
Condition: Drug Safety
Study type: Interventional
Phase: Phase 1

Summary: 
      Aim of the present study is:

        -  To evaluate the safety and tolerability of increasing doses of intravenous liposomal
           Curcumin in healthy subjects by means of adverse events, vital signs and safety
           laboratory assessments.

        -  To investigate the pharmacokinetics of increasing doses of intravenous liposomal
           Curcumin in healthy subjects.
    


Intervention name(s): Liposomal Curcumin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Single dose intravenous infusion of liposomal Curcumin at 10, 20, 40, 80, 120, 180 mg/m² over 120 minutes; 5% glucose infusion over 120 minutes
Intervention MeSH terms: Curcumin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Safety; Tolerability; Pharmacokinetics; Liposomal Curcumin