cyrilzakka/clinical-trials huggingface dataset:
Study to Eval Relation Btw Doctor/Pharmacy Shopping & Outcomes of Misuse, Diversion, Abuse, Addiction by Med Rec Review

To assess whether the percentage of patients with behaviors suggestive of misuse, diversion, abuse and/or addiction described in the medical record increases across pre-defined categories of increasing doctor/pharmacy shopping behavior.

Based on a review of the literature, the Food and Drug Administration (FDA) concluded that more data are needed regarding the serious risks of misuse, abuse, addiction, overdose, and death associated with the long-term use of extended release/long acting (ER/LA) opioid analgesics. Thus, the FDA is requiring that ER/LA opioid analgesic drug sponsors conduct post-marketing studies to assess these risks. The four observational post-marketing requirement (PMR) studies are labeled Study #2065-1, Study #2065-2, Study #2065-3, and Study #2065-4.

The objective of PMR Study #2065-4 is to define and validate doctor/pharmacy shopping as outcomes suggestive of misuse, diversion, abuse and/or addiction.

Study #2065-4 consists of three sub-studies, Study 4A, Study 4B, and Study 4C. In the current study (#2065-4 sub-study, Study 4C), the association of doctor/pharmacy shopping behavior with misuse, diversion, abuse and/or addiction will be assessed by reviewing medical charts in a sample of patients within specific categories of a priori defined doctor/pharmacy shopping. The four categories of doctor/pharmacy shopping behaviors identified and defined in Study 4A and will be applied to Study 4C. The medical chart is a rich source of information about the patient's medical conditions and behaviors suggestive of misuse and abuse. Medical record review for behaviors suggestive of misuse and abuse in patients with chronic pain discriminates between patients with and without opioid use disorders. Therefore, Study 4C was designed to utilize an insurance/health plan database (HealthCore Integrated Research Database \[HIRD\]) with access to medical records, to evaluate the association of a priori defined categories of doctor/pharmacy shopping and behaviors suggestive of misuse, diversion, abuse and/or addiction.

Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 years or older on the date of first IR or ER/LA opioid dispensing in 2012
2. Patients with at least two dispensings of any IR or ER/LA opioid. The first of these dispensings will have occurred in 2012 and an additional dispensing within 18 months after the first.
3. Continuous, fully insured enrollment with medical and pharmacy eligibility in a health plan included in the HealthCore Integrated Research Database (HIRD) for at least six months prior to the start of the follow-up period.
4. Patients with continuous enrollment during the follow-up period of 18 months

Exclusion Criteria:

1. Patients who cannot be classified into one of the four a priori defined doctor/pharmacy shopping categories
2. Patients for whom no medical records can be accessed
3. Patients with a known history of abuse identified through the administrative claims data will be excluded because HealthCore is not permitted to request their medical records.
Effect of Garlic on Inflammatory Mediators

This research will investigate the effect of garlic oil extract when added to daily diet on inflammatory mediators and blood clotting activation.

To investigate the pharmacokinetics of one of the garlic oil macerate, Ajoene, the anti-inflammatory effect of garlic oil macerate on the pro-inflammatory transcription factor NF-kB, it's activating proteins, including IkB, IkB Kinases a and B (IKKa and IKKB) and the pro-inflammatory NF-kB-regulated proteins, c-reactive protein (CRP), tumor necrosis factor-alpha (TNF-a), soluble intercellular adhesion molecule-1 (sICAM-1), soluble vascular cell adhesion molecule-1 (sVCAM-1), matrix metalloproteinase-9 (MMP-9), plasminogen activated protein-1 (PAI-1)and the effect of garlic oil macerate intake on platelet activation in normal subjects.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Normal subjects with BMI \<25, obese subjects with BMI \>30
* Subjects who have consented to adhere to the diet, regular weekly visits, and blood draws.

Exclusion Criteria:

* Subjects on any antioxidant medication.
* Patient on non-steroidal anti-inflammatory drug.
* On any agent with antioxidant properties.
* History of drug or alcohol abuse.
* Any life threatening disease.
* On any agent with significant antioxidant properties.
* Taking garlic extracts in the diet regularly.
Safety, Tolerability and Pharmacokinetics of Inhaled Doses of AZD4818 in Healthy Japanese Male Volunteers

The purpose is to investigate safety and tolerability of single and multiple ascending inhaled doses of AZD4818 in healthy Japanese male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent
* Body Mass Index (BMI) between 18.0-27.0 kg/m2
* No clinically relevant abnormal findings

Exclusion Criteria:

* Acute illness which requires medical intervention
* Definite or suspected personal history of adverse drug reactions or drug hypersensitivity.
* Clinical relevant disease or disorder (past or present)
* A history of respiratory disorders
Efficacy of Melatonin in Patients With Severe Sepsis or Septic Shock

OBJECTIVES. To establish the therapeutic efficiency of melatonin in adult patients with severe sepsis and septic shock.

Specifically:

1. To evaluate the survival to 28 days of mechanical assisted ventilation, days with vasoactive drugs, need of hemodialysis-hemofiltration, superinfection and evolution towards the failure of other organs.
2. To evaluate, waiting for reduction under the influence of the treatment with melatonin, :

   1. clinical - analytical parameters of sepsis;
   2. levels of cytokines;
   3. oxidative and nitrosative stress;
   4. acute-phase proteins (APP), specially of the ITIH4;
   5. immune response;
   6. endocrine response.

METHODOLOGY. Patients will be randomized in two groups, n = 55 in each group: 1) treatment with melatonin 30mg/12 hours 28 days; 2) placebo.

Determinations: a) clinical - analytical parameters relative to the sepsis; b) melatonin plasmatic levels; c) quantification of malonyldialdehyde and 4-hydroxynonenal, protein carbonyl content, nitrites, erythrocyte membrane fluidity, and superoxide dismutase, catalase, glutathione reductase and glutathione peroxidase activity; d) Interleukins-1,2,4,5, 6, 7,8,10,12,13, IFN-γ; TNF-α and GM-CSF; e) acute-phase proteins: PCR, haptoglobin, Apo A-I, α1-GPA and ITIH4; f) lymphocytes T, B, NK, T CD4, and T CD8, and immunoglobulins; g) cortisol, aldosterone, ACTH, ADH, insulin, glucagon and 25-hydroxyvitamin D3. Data will be analyzed following a prospectively define plan and by intention-to-treat (ITT) analysis.

This study will be done in the Hospital Clinico Lozano Blesa (Zaragoza, Spain), promoted by the Health Science Aragon Institute and its principal investigator is F. Agustín García Gil (Surgical Service). It will start in April-May 2013 and will finish 12 months later approximately. The study sponsor is I+CS (Aragon Institute of Health Sciences).

Eligibility Criteria:
Inclusion Criteria:

* patients (males and females) over 18 years who meet the diagnostic criteria for severe sepsis or septic shock secondary to community-acquired pneumonia or hospital and or intra-abdominal infection

Exclusion Criteria:

* Patient with more than 24 hours from the first documentation of organ dysfunction
Smoking Cessation Program in the Preadmission Clinic: The Use of a Teachable Moment

The Objective of this study is to introduce a practically feasible multifaceted intervention in the preadmission clinic to help reduce smoking in preoperative surgical patients. The investigators aim to study the effectiveness of such a program in promoting positive change in smoking behavior among patients before surgery. The forced abstinence enforced on patients during hospital stay for their surgery can also be used to help smokers remain tobacco free long term. A significant percentage of surgical patients will be receptive to smoking cessation interventions in the preadmission clinic and will refrain from smoking at 24 and 52 weeks after starting the treatment.


Eligibility Criteria:
Inclusion Criteria:

* The investigators will recruit patients who are assessed in preadmission clinic and scheduled for elective surgical procedures within the next 8 to 30 days.
* Patients should be 18 yrs of age, have smoked an average 10 cigarettes/day or more during the previous year and had no period of smoking abstinence longer than 3 months in the past year.

Exclusion Criteria:

* current pregnancy, breastfeeding;
* major depression, panic disorder, psychosis, or bipolar disorder within the prior year;
* use of nicotine replacement or bupropion within the previous 3 months;
* cardiovascular disease within the past 6 months;
* a serious or unstable disease within the past 6 months;
* drug or alcohol abuse or dependence within the past year;
* and use of tobacco products other than cigarettes or marijuana use within the previous month;
* participating in any other studies
* Patients who cannot understand English or have any form of cognitive impairment will be excluded.
Lag of Accommodation With DOT Spectacle Lenses

The objective of the study is to measure the difference in the lag of accommodation between DOT spectacle lenses and control spectacles.


Eligibility Criteria:
A person is eligible for inclusion in the study if he/she:

1. Age 6-18 years of age, with a maximum of 6 of the first 25 completed participants being older than 14 years of age.
2. Is able to read (or be read to), understand and sign the assent document if under 17 years old or is able to read, understand and sign the consent document if aged 17 or 18 years.
3. Is under 17 years old and is accompanied by a parent or legal guardian who is able to read, understand and sign the parental information and permission document.
4. Should be emmetropic by non-cycloplegic auto-refraction, which means both refractive meridians should be within +1.00D and -1.00D.
5. Is willing and able to follow instructions.

A person will be excluded from the study if he/she:

1. Is participating in any concurrent clinical or research study.
2. Have a history of myopia control treatment in the past year.
3. Has amblyopia in either eye or known to have any other binocular vision disorder, such as accommodative insufficiency.
4. Has any known active ocular disease and/or infection.
5. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable. Examples include diabetes mellitus, hyperthyroidism.
6. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable. Examples include Atropine eye drops.
7. Has undergone strabismus surgery, refractive error surgery or intraocular surgery.
8. Is a child of a member of the study team.
SMART Trial: Community Stigma Reduction

The goal of this project is to engage community members from two low-income African American communities (N=200) in a survey study that assesses stigma toward those with Opioid Use Disorder (OUD). Those from the intervention community will be subject to a stigma reduction campaign via billboards. Those from the control community will not. Stigma will be re-assessed following the period of the campaign.


Eligibility Criteria:
Inclusion Criteria:

* Identify as African American or Mixed race
* Reside in Frayser or Orange Mound Communities
* Access to telephone for follow-up assessment

Exclusion Criteria:

* Unable to understand consent procedures
Extension Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients with Hereditary Angioedema

This study evaluates the safety and efficacy of long-term on-demand treatment with orally administered deucrictibant for acute hereditary angioedema (HAE) attacks, including laryngeal attacks, in participants with HAE type 1 or type 2 (HAE-1/2). The study will enroll patients from Study PHA022121-C201 (NCT04618211) and Study PHA022121-C306 (NCT06343779) who elect to participate in this extension study and meet the eligibility requirements.

Part A of the study will enroll adult participants from Study PHA022121-C201. The double-blind treatment assignment from Study PHA022121-C201 will be maintained.

Part B will include participants rolling over from Part A and additionally enroll participants from Study PHA022121-C201 who did not participate in Part A, and participants from Study PHA022121-C306 who elect to participate in this extension study and meet the eligibility requirements.

Eligibility Criteria:
Key Inclusion Criteria:

1. Signed and dated informed consent form
2. Diagnosis of HAE type I or II
3. For participants from Study C201, received at least one dose of study drug (including the non-attack visit) in Study C201. For participants from Study C306, participant was randomized (and for adolescent participants 12 to \<18 years received a dose of study drug in a non-attack state at Visit 1) and completed Study C306, with 2 attacks treated, or after closure of that study by the Sponsor.
4. In the opinion of the Investigator, the participant (and parent/caregiver for adolescent participants) is willing and able to comply with the protocol.

Key Exclusion Criteria:

1. Pregnancy or breast-feeding
2. Any other systemic disease or significant disease or disorder that would interfere with the patient's safety or ability to participate in the study
3. Use of lanadelumab for long-term HAE prophylactic therapy within 12 weeks prior to enrollment in Part A.
4. For Part A: Use of C1-esterase inhibitor, oral kallikrein inhibitors, attenuated androgens, anti-fibrinolytics, or monoclonal HAE therapy within a defined period prior to enrolment.

   For Part B: If a participant is receiving long-term prophylactic therapy with one of the following medications indicated for HAE: plasma-derived C1-INH, danazol at less than or equal to 200 mg/day, anti-fibrinolytics, berotralstat, or lanadelumab, they must be on a stable dose and regimen for at least 3 months before screening and intends to remain on the same dose for the duration of the study.
5. History of alcohol or drug abuse within defined period, or current evidence of substance dependence or abuse
6. Participation in any other investigational drug study within defined period
7. Discontinued from parent study after enrollment for any study drug-related safety reason.
8. Use of concomitant medications that are potent CYP3A4 inhibitors (e.g., clarithromycin, erythromycin, itraconazole, ketoconazole, ritonavir, grapefruit) or potent CYP3A4 inducers (e.g., phenytoin, rifampicin, St. John's Wort).
Systematic Escalation of diuREtics With Natriuresis in Heart Failure Patients: SERENA Trial

The present is a multicenter, prospective, randomized, open-label, blinded end-point trial aiming to investigate the clinical benefit of a stepwise, natriuresis-driven diuretic strategy versus standard diuretic treatment in patients with acute decompensated heart failure with reduced ejection fraction (HFrEF) and low early urinary sodium excretion. The study will focus on patients at increased risk of resistance to diuretic therapy. In particular, patients admitted to the emergency department and cardiac intensive care unit due to an on-chronic or de-novo acute decompensated HF episode with a predominantly "wet" profile and low early spot urinary sodium (UNa+) excretion will be considered. Spot natriuresis is a low-cost, non-demanding laboratory test in use to identify diuretic-resistant patients with an inherent poor prognosis. Whether the early identification of diuretic resistant patients and the consequent more aggressive treatment may lead to a better outcome has not been demonstrated by randomized studies. This trial aims to assess if an intensive stepwise diuretic approach guided by systematic urinary output assessment including natriuresis evaluation versus a standard diuretic strategy based on urinary output alone effectively leads to faster euvolemia achievement and better prognosis in a real-world setting.


Eligibility Criteria:
Inclusion Criteria:

* Admission for acute decompensate chronic heart failure or acute de novo heart failure
* Ejection Fraction \<40%
* Severe signs and symptoms of congestion with modified wet score ≥ 12
* Spot urinary sodium excretion ≤ 70 mEq/L at 2 hours from first intravenous loop diuretic administration
* Systolic blood pressure ≥90 mmHg

Exclusion Criteria:

* Reversible etiology of acute heart failure (including acute coronary syndromes, myocarditis, acute pulmonary embolism, acute rhythm disorders, severe organic valve disease)
* Cardiogenic shock at admission or sign of hypoperfusion needing inotropic agents or mechanical circulatory support.
* eGFR lower than 15 ml/min/1.73m2 or dialysis
* Pregnancy or breastfeeding
Analysis of Metabonomics for Pleural Effusion

This is a multicenter retrospective study that collected diagnostic information of patients with pleural effusion. The overall survival (OS) time of malignant patients was followed up, defined as the time from diagnosis to death. Clinical data and residual pleural effusion specimens were collected from patients. Metabonomics was utilized to differentiate between benign and malignant pleural effusion and to evaluate the prognosis of lung cancer patients with malignant pleural effusion.

Pleural effusion (PE) is a common yet challenging problem in clinical settings. PE is a symptom caused by over 50 diseases and is typically classified as either malignant pleural effusion (MPE) or benign pleural effusion (BPE). MPE affects a significant number of individuals, with an estimated annual incidence of 500-700 cases per million population. Metastatic cancer is the leading cause of MPE, and lung cancer accounts for approximately 37.5% of cases. The management of MPE is a major clinical challenge due to its association with a typically poor prognosis, with a median survival of only 3 to 12 months. However, predicting survival in MPE patients can be difficult due to significant heterogeneity in underlying malignancy and patient performance status. Therefore, accurate prognostication remains a significant challenge in the management of MPE.

Metabonomics is an analytical technique for detecting metabolites in biological samples and has been widely used in disease diagnosis and prognosis evaluation in recent years. The aim of this study is to use Metabonomics technology to compare and analyze the differences in metabolites between benign and malignant pleural effusion, and to explore its application in the prognosis evaluation of lung cancer patients with malignant pleural effusion.

Eligibility Criteria:
Inclusion Criteria:

* 18 Years to 80 Years; detection of pleural effusion by chest computed tomography, radiography, or ultrasonography; pathologically confirmed lung cancer in pleural effusion.

Exclusion Criteria:

* pleural effusion not caused by lung cancer or of unknown origin; other concurrent malignant diseases; incomplete information; lack of any follow-up data.
Unravelling the Interplay of Weight Stigma and Pregnancy Outcomes: A Prospective Cohort Study

The goal of this prospective cohort study is to investigate the contribution of stigma and discrimination due to body size to adverse pregnancy outcomes. We also aim to explore the role of psychological and social factors in this relationship. The specific objectives of this study are:

Objective 1: Explore weight stigma as a mediator of the association between BMI ≥30 kg/m2 and adverse pregnancy outcomes.

Objective 2: Explore confounding factors not previously considered such as weight cycling, trauma, eating disorders, and internalised weight bias as mediators in the relationship between obesity and adverse pregnancy outcomes.

The specific research questions for each objective are:

Objective 1 RQ1.1: Does weight stigma experienced during pregnancy in a healthcare setting reported up to 34 weeks gestation mediate the association between pre-pregnancy obesity (BMI ≥30) and gestational diabetes mellitis (GDM) (primary outcome)?

RQ1.2: Does weight stigma experienced during pregnancy in a healthcare setting reported up to 34 weeks gestation mediate the association between pre-pregnancy obesity (BMI ≥30) and (i) induction of labour; (iv) mode of birth; (ii) gestational hypertension (any); (iii) infant birth weight; and (iv) establishment of breastfeeding by 6 weeks postpartum (secondary outcomes)?

Objective 2:

RQ2.1: Do weight cycling, history of trauma, history of eating disorders, and internalised weight bias explain any of the variance in the mediation relationships described above?

Eligibility Criteria:
Inclusion Criteria:

* Pregnant between 10-22 weeks' gestation
* Greater or equal than 18 years of age
* Booked to give birth at Adelaide Women's and Children's Hospital or Royal Women's and Children's Brisbane
* Access to the Internet to complete the survey
* Consents to the extraction of hospital electronic medical record data about the woman and relevant to the study.
* Ability to read and understand English

Exclusion Criteria:

* Pregnant with multiple gestation
* Insufficient English language skills to consent and complete the questionnaires.
International Consortium Investigating Early Vitrectomy in Diabetic Macular Edema Patients

The purpose of this research is to evaluate the effectiveness of vitrectomy for the treatment of diabetic macular edema. Diabetes is known to cause retinal blood vessels to leak, leading to swelling of the central retina (macula), and decreased vision. Removing the vitreous gel with vitrectomy surgery is known to decrease the swelling caused by diabetes. Diabetic retinopathy is often treated with laser or injections of medicine in to the eye.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, \> 18 years of age with type 1 or 2 diabetes mellitus diagnosed and treated by an endocrinologist, internist or family medicine physician
* Background diabetic retinopathy
* DME with central subfield thickness (CST) \> 325 µm by Spectral Domain Optical Coherence Tomography (SD-OCT)
* HbA1c level of \< 10.0 mg/dl
* Previous cataract surgery with implantation of a stable posterior chamber intraocular lens or a phakic eye with 1+ (out of 4+ scale) or less lens opacification
* Predominantly intact (80%) external limiting membrane (ELM) and photoreceptor inner/outer segment (IS/OS) lines within 500 µm of the fovea on horizontal and vertical SD-OCT scans
* Best corrected Snellen visual acuity from 20/40 to 20/280 inclusive.

Exclusion Criteria:

* Intraocular anti-vascular endothelial growth factor (VEGF) injection within the previous 3 months
* Systemic anti-VEGF or receptor tyrosine kinase inhibitor therapy within the previous 3 months
* Intraocular corticosteroid injection within the previous 6 months
* Peri-ocular corticosteroid injection within the previous 3 months
* Vitreomacular traction on SD-OCT scan (epiretinal membrane is allowed)
* Previous anterior or pars plana vitrectomy
* Glaucoma (IOP of \> 21 mmHg or regular use of more than 2 IOP lowering drugs)
* Previous trabeculectomy
* Likelihood of needing intraocular surgery within 6 months
* Hard exudates involving the fovea
* Proliferative diabetic retinopathy with any evidence of retinal traction
* Cataract of grade 2+ or greater.