cyrilzakka/clinical-trials huggingface dataset:
Thiamine, Vitamin C and Hydrocortisone in the Treatment of Septic Shock

The purpose of this research study is to determine whether patients who receive thiamine (vitamin B1), vitamin C and hydrocortisone while in septic shock have improved outcomes compared to hydrocortisone alone.

A recently published article "Hydrocortisone, Vitamin C and Thiamine for the treatment of Severe Sepsis and Septic Shock," suggested substantial mortality reduction (78%). We wish to test the hypothesis that mortality reduction is at least 25% in a prospective randomized trial. Other important sub-aims include the testing whether the protocol reduces the time on pressors agents, reduces the trajectory of the SOFA score, or reduces the trajectory of procalcitonin.

The study has four specific aims. The first is to utilize the Marik protocol published in CHEST to determine mortality reduction in septic shock with thiamine (vitamin B1), vitamin C and hydrocortisone supplementation. The second aim is to determine whether supplementation with thiamine, vitamin C and hydrocortisone reduce time spent on vasopressor support. Thirdly, whether the trajectory of the SOFA score is affected by supplementation with thiamine, hydrocortisone and vitamin C. Fourthly, assess the trajectory of procalcitonin, a laboratory test, in patients treated with the protocol.

This is a single center community based hospital in Southwest Michigan, investigator blinded, randomized placebo controlled trial, 24 month, parallel group, two arm, superiority study with a 1:1 allocation ratio to compare the efficacy of thiamine, vitamin C and hydrocortisone in the treatment of severe sepsis and septic shock. Each arm of the research study will contain 30 patients in order to detect a 25% mortality reduction. Enrollment for this study will be initiated in patients with septic shock that require addition of a second pressor agent. The control arm of our randomized trial will receive a second pressor agent, hydrocortisone and standard of care. If the patient needs additional pressor support or therapy, that will be recorded in the results.

The experimental arm will receive a second pressor agent and hydrocortisone, plus thiamine and vitamin C along with the standard of care. If the patient needs additional pressor support or therapy that will be recorded in the results.

To clarify, both arms will utilize two vasopressor agents, hydrocortisone and supportive care, the experimental group will also receive vitamin C and thiamine.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Septic Shock on two vasopressor agents
2. Age between 18-90 years old
3. Ability to provide written informed consent

Exclusion criteria include:

1. Age younger than 18 years old
2. Pregnancy
3. DNR or DNI status with limitations of care, such as "supportive care only"
4. Patients/advocates that request thiamine, vitamin C or hydrocortisone supplementation
Impact of Enhanced Daily Disinfection on Environmental Contamination in Hospital Rooms

The purpose of this study is to determine if enhanced daily application of disinfectant with persistent 24-hour activity decreases the environmental bioburden compared to standard practice.

The study investigator will evaluate the effectiveness of daily disinfection strategies on environmental contamination in acute care hospital rooms.

The trial will be conducted in acute care hospital rooms at Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, and the University of North Carolina Medical Center. In each study room, one half will be randomized to the control arm, and the other half will be randomized to one of the two intervention arms. Two separate randomization steps will occur. First, each room will be randomized to Intervention 1 or Intervention 2. Second, the half of the room to which the intervention will be applied (e.g., right vs. left) will be randomly selected. The control arm will receive no interventions. Rooms randomized to the control arm will undergo routine disinfection via existing Environmental Services (EVS) protocols. All study hospitals routinely use EPA-registered disinfectants for low-level disinfection of hospital room surfaces. Intervention 1 is the standard EPA-registered disinfectant to each study surface and will be applied by the study team. Intervention 2 is a quaternary ammonium, salt-based, 24-hour continuously active germicidal wipe (Sani-24®) to each study surface and will be applied by the study team.

Three different methods will be used for disinfection. No changes to baseline and routine disinfection practices will occur during the study. EVS employees at study hospitals will be responsible for the total room cleaning and disinfection throughout the study. Tasks will be separated between study team members to maintain blinding.Room contamination will be measured before the application of the interventions on study day 1 and every 24 hours for 3 subsequent days, for a total of 4 days. Secondary outcomes include evaluation for epidemiologically important pathogens (EIP), including me staphylococcus aureus (MRSA or MSSA), extended spectrum beta-lactamase (ESBL) or carbapenem-resistant Enterobacteriaceae (CRE) producing Enterobacterales, vancomycin-resistant Enterococci (VRE), vancomycin-susceptible Enterococci (VSE), Acinetobacter spp., and Pseudomonas aeruginosa.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient admitted to the room
* Patient spent ≥1 night in room prior to enrollment
* Anticipated patient stay of ≥48 hours
* On contact precautions (for any reason) and/or has positive culture for EIP at the time of room admission

Exclusion Criteria:

* Patient stay is expect to be \<48 hours
* Patient age \<18, even if on adult ward
* Patient admitted on respiratory precautions due to coronavirus disease (COVID-19), influenza, or respiratory syncytial virus (RSV)
* Patient on contact precautions due to C. difficile
Sofosbuvir With Pegylated Interferon and Ribavirin Hepatitis C Virus (HCV) Genotypes 1,4,5,6

The purpose of this study is to assess the safety, tolerability, and efficacy of sofosbuvir (GS-7977; PSI-7977) administered in combination with pegylated interferon and ribavirin (PEG/RBV) in treatment-naive patients with HCV genotypes 1,4,5,6, or indeterminate genotype.


Eligibility Criteria:
Inclusion Criteria:

* Males and females with Chronic Hepatitis C (HCV) Genotype 1,4,5,6, or indeterminate
* Naive to previous HCV treatment

Exclusion Criteria:

* Positive for HBsAg, anti-HBc IgM Ab, or anti-HIV Ab
* History of any other clinically significant chronic liver disease
Investigating Patient Satisfaction With Oral Anti-cancer Treatment in Patients With Hormone-receptor Positive, HER2-receptor Negative, Advanced Breast Cancer

A prospective, non-interventional, non-controlled multicenter observational study to evaluate aspects of pharmaceutical care and the treatment of postmenopausal patients with hormone-receptor positive, HER2-receptor negative, advanced breast cancer treated with everolimus and exemestane.

The main objective of the study is to evaluate medication adherence in postmenopausal, hormone-receptor positive, HER2-receptor negative, advanced breast cancer treated with a combination of everolimus and exemestane. Additionally, other aspects of the pharmacotherapy, with focus on the patient perspective, will be investigated:

* Patient satisfaction with treatment information
* Patient satisfaction with treatment
* Health-related quality of life
* Treatment efficacy
* Treatment-related toxicity
* Patient follow-up by the oncologic team/general practitioner and or specialized home nurses

This study should reveal information necessary for the development of pharmacotherapeutic care concepts that meet the needs of cancer patients treated with an oral anti-cancer drug over a long period.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women, 18 years or older
* Signed written informed consent
* Patient can be contacted by phone and/or e-mail
* HR+, HER2- advanced or metastatic breast cancer
* Recurrence or progression following a non-steroidal aromatase inhibitor
* Able to swallow and retain oral medication
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2

Exclusion Criteria:

* Patients who are not able to understand Dutch or French
* Symptomatic visceral metastatic disease
* Patients who have taken an investigational drug within 28 days or 5 half-lives, whichever is shorter, prior to recruitment
* Current use of a prohibited medication as described in the SPC
* Any serious or unstable pre-existing medical conditions, psychiatric disorders, or other conditions that could interfere with the subject's safety, obtaining informed consent, or compliance with study procedure
* Hypersensitivity to the active substances or to any of the excipients
A Study of Nystatin in the Prevention of Fungal Infections of the Mouth in Patients With AIDS or AIDS-Related Syndromes

To determine a safe, effective, and convenient dosing schedule for nystatin pastilles in the prophylaxis of oral candidiasis in patients with AIDS or AIDS related syndromes (group III or IV, CDC classification)


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Experimental drugs (IND drugs) which are targeted specifically against the AIDS virus or which stimulate the immune system.
* Systemic or oral antibiotics.

Patients must have AIDS or AIDS-related syndromes (HIV infection:

* Group III or IV, CDC classification) and not have been treated for oral candidiasis during the past year.
* Patients can be entered into the study who have:
* Other oral lesions due to Kaposi's sarcoma, herpes zoster, and herpes simplex.
* A positive or negative oral culture for Candida.
* Must be able to follow instructions regarding the use of a pastille.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Oral lesions diagnostic of oral candidiasis or systemic candidiasis.
* Suspected or proven candidal esophagitis.

Patients with the following are excluded:

* Oral lesions diagnostic of oral candidiasis or systemic candidiasis.
* Receiving any effective antifungal agent orally or intravenously within 72 hours of study entry.
* Not expected to survive for at least 6 months.
* Unable to voluntarily maintain a pastille in the buccal cavity for approximately 20 minutes twice a day.
* Known hypersensitivity to nystatin.
* Suspected or proven candidal esophagitis.

Prior Medication:

Excluded within 72 hours of study entry:

* Any oral or intravenous antifungal agent.
A Seek, Test, and Treat Intervention to Reduce Chlamydia Trachomatis Disparities

This study includes testing for four STIs (chlamydia, gonorrhea, syphilis, and HIV) at no cost. If positive, individual subjects will also be counseled and offered options for treatment for themselves and their sex partners that may include no cost expedited treatment and the option to be rescreened 3 months after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Identifies as African American or Black
* 15-26 years of age
* Lives or spends most of their time in Orleans Parish
* Had vaginal sex at least once

Exclusion Criteria:

* Unwilling or unable to provide informed consent
* Unable to speak or understand English
* Previously enrolled in the study
* Known to be pregnant
* Known HIV positive status
Effect of Salmeterol on Brain-Derived Neurotrophic Factor (BDNF) Concentrations in Asthma

BDNF has been linked to the pathogenesis of airway hyperresponsiveness in asthma. In this trial, the impact of a treatment with salmeterol and salmeterol / fluticasone on BDNF concentrations will be assessed in patients with asthma. The investigators hypothesize that salmeterol impacts on BDNF concentrations in patients with asthma.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years, a physician's diagnosis of allergic asthma
* A documented sensitization to aero-allergens (pollen, animal hair, or house dust mite)
* A pre-bronchodilator forced expiratory volume in the first second (FEV1) \> 80 % of the predicted value (% predicted), a provocative concentration of histamine causing a 20 % fall in FEV1 (PC20) of \< 8 mg histamine / ml

Exclusion Criteria:

* No regular treatment (only short-acting inhalers on demand were allowed)
* No history of or evidence for any other chronic disease than asthma
* No history of smoking, absence of any signs or symptoms of an infection
Study of Capecitabine in Metastatic Non-clear Cell Renal Cell Carcinoma (RCC) Patients

Capecitabine is an orally-administered chemotherapeutic agent used in the treatment of metastatic breast and colorectal cancers. The role of capecitabine in treatment of metastatic renal cell carcinoma is discussed. In this trial, we are evaluating efficacy of capecitabine in metastatic renal cell carcinoma patients.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed non-clear cell renal cell carcinoma
* confirmed metastatic sites
* no chemotherapy in history

Exclusion Criteria:

* metastases in CNS
* previous targeted therapy
* other tumor
Manual Therapy for Oropharyngeal Function and Upper Quarter Mobility on Head and Neck Cancer Survivors

Trismus has been reported as the second most common comorbidity in survivors of head and neck cancer (HNC). It is mainly associated with post-radiotherapy subcutaneous fibrosis, muscular atrophy, damage to neurological structures in the neck, or a combination of all, affecting masticatory musculature. In addition to this, the loss of flexibility and strength in the shoulder has also been shown to be related to deficits in the function and quality of life of these patients.

The goal of this clinical trial is to determinate the effectiveness and safety of Manual Therapy (MT) on Oropharyngeal Function, as well as the mobility of the upper quarter, the strength of cervical musculature, pain, functionality, and the perception of quality of life in head and neck cancer survivors.

Participants will be assigned randomly to the study groups: a) manual therapy program and control motor exercises and b) motor control exercises (usual care).

The assessment refers to a baseline form (at the beginning of the study), at 6 weeks and at 6 weeks of patient follow-up.

Manual therapy program consists of 3 sessions a week during 6 weeks, with a total of 18 appointments. Measurements are done before starting, after the last intervention and 6 weeks after finishing the treatment.

Eligibility Criteria:
Inclusion Criteria:

* individuals with HNC
* individuals over 18 years of age
* individuals who have undergone oncological surgery of the head and neck and/or radiotherapy
* having finished oncological medical treatment between 3 and 36 months before inclusion
* having a medical diagnosis of trismus and/or TMD and/or cervical or shoulder dysfunction

Exclusion Criteria:

* sequelae of previous stroke
* structural instability and/or osteoporosis of the cervical spine, spondylosis, cervical herniated discs
* active osteoradionecrosis or open wounds (fistulas, soft tissue necrosis) in the anatomical treatment area
* tracheostomized individuals
* metastasis or active cancer
* refuse to participate.
The Living With a Long-Term Condition Study

Psychological distress (anxiety and depression) is common in and experienced differently by people living with long-term health conditions (LTCs). Being able to measure whether psychological distress is related to living with a LTC would allow researchers and clinicians to provide interventions specifically tailored to the challenges of living with a LTC and therefore provide the most appropriate support for these patients. Such a measure would also be useful in research to identify the presence of illness-related distress in different patient groups. This project will therefore create a new measure of illness-related distress that has applications for both research and clinical practice. This will involve the psychometric validation of the new illness-related distress measure to test how valid and reliable the measure is.

The aim of the project is to provide initial validation of the Illness Related Distress Scale in a community sample, recruited through online platforms. The objective of the study is to gather initial validity and reliability data for the scale.

Background: see brief summary

Project information:

This study will be conducted online with participants from the UK. A series of standardised questionnaires will be used alongside the new questionnaire.

Participants will be those who self-select to complete our survey by responding to advertisements. The invitation will include a link to the Qualtrics survey which includes the Participant Information Sheet, Eligibility Screening, Consent Form and Baseline Questionnaire.

After completing eligibility screening and consent, participants will complete the baseline questionnaire which will include brief demographics (highest education level, long-term condition diagnoses, ethnicity age and gender), the new measure we are testing (the Illness Related Distress Scale), as well as the Patient Health Questionnaire (PHQ-8), Generalised Anxiety Disorder Scale (GAD-7), the Work and Social Adjustment Scale (WSAS). The baseline questionnaire will only include the Inflammatory Bowel Disease Distress Scale (IBD-DS) and Diabetes Distress Scale (DDS) if participants indicate that they have a diagnosis of the relevant condition.

At 1 week follow-up, participants will be sent a Qualtrics link to complete our 1-week follow-up questionnaire which will include the new Illness-Related Distress Scale only.

Participants:

We are aiming to recruit 600-700 participants for the study.

Eligibility Criteria:
Inclusion Criteria:

* Over the age of 18
* Self-reported diagnosis of a Long-Term Condition
* UK resident
* Possession of an email address to enable all study procedures
* Sufficient command of written and spoken English to understand study procedures

Exclusion Criteria:

* Under the age of 18
* Not living in the UK
* No self-reported diagnosis of an LTC
* Inability to complete questionnaires in English
Oncological Outcomes of Different Patterns of Tumor Recurrence at First Evaluation After Bacillus Calmette-Guérin Induction Therapy for Intermediate and High Risk Non Muscle Invasive Bladder Cancer

This retrospective study aimed at assessment of different patterns (morphological and pathological) of tumor recurrence found at first evaluation after BCG induction therapy (3 months cystoscopy) for intermediate and high-risk NMIBC and its prognostic implications at a tertiary referral center.

Bladder cancer (BCa) is the second most common genitourinary malignancy with approximately 75-85% of all patients with BCa present at diagnosis a non-muscle invasive bladder cancer (NMIBC) (Ta, T1 and Tis). Although NMIBC usually carries a favorable prognosis, there is a high risk of disease recurrence and a 10% to 20% risk of progression to muscle-invasive disease.

The common treatment for intermediate- and high-risk patients is a transurethral resection followed by intravesical therapy with bacillus Calmette-Guerin (BCG), a non-specific immunotherapy that has remained the gold standard for 40 years. Over the last decades, several studies have confirmed the superiority of BCG over the combination of epirubicin and interferon, mitomycin C or epirubicin alone for prevention of tumor recurrence, in intermediate- and high-risk tumors.

Despite wide acceptance of BCG intravesical therapy in intermediate and high risk NMIBC, there is still a controversy regarding the optimal protocol of administration. However, most of the guidelines have recommended an induction regimen of six weekly BCG instillations followed by maintenance instillation for at least 1 year.

Complete response (CR) rates after an induction course of BCG for intermediate and high risk NMIBC are high and range from 50-70%. Tumor recurrence at first evaluation (3-months cystoscopy) after BCG induction therapy has been defined as a poor prognostic indicator in those groups of patients with an increased potential risk of disease recurrence and /or progression.

Different patterns of tumor recurrence may be encountered at 3-mo cystoscopy during first evaluation after induction therapy either morphological (single tumor vs. multiple, \<3 cm or more, site (? bladder neck involvement), papillary or non papillary) or histopathological (Ta vs. T1, concurrent CIS or not, tumor grade). To determine how to optimally manage those heterogeneous groups of patients, studying of the specific impact of different tumor characteristics on oncological outcomes is warranted.

Eligibility Criteria:
Inclusion Criteria:

* Patients for who complete TURBT, was carried out
* Intermediate and high risk NMIBC.
* Patients who received full induction BCG regimen (6 weekly doses).
* Patients completed at least 12 months follow up after 3 months cystoscopy.

Exclusion Criteria:

* Patients who received incomplete induction BCG regimen (less than 6 weekly doses)
* Patients with incomplete (less than 12 months) follow up.
Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCZ696 Followed by a 52-week, Double-blind Study of LCZ696 Compared With Enalapril in Pediatric Patients With Heart Failure

This study consists of two parts (Part 1 and Part 2). The purpose of Part 1 is to evaluate the way the body absorbs, distributes, metabolizes and removes the drug LCZ696. This will help determine the proper dose of LCZ696 for Part 2 of the study.

The purpose for Part 2 is to compare the effectiveness and safety of LCZ696 with enalapril in a double-blind manner, in pediatric heart failure patients over 52 weeks of treatment.

This study consists of two parts (Part 1 and Part 2). The purpose of Part 1 is to evaluate the way the body absorbs, distributes, metabolizes and removes the drug LCZ696. This will help determine the proper dose of LCZ696 for Part 2 of the study.

The purpose for Part 2 is to compare the effectiveness and safety of LCZ696 with enalapril in a double-blind manner, in pediatric heart failure patients over 52 weeks of treatment.

Eligibility Criteria:
Key Inclusion Criteria:

* Chronic heart failure (CHF) resulting from left ventricular systolic dysfunction, and receiving chronic HF therapy (if not newly diagnosed)
* New York Heart Association (NYHA) classification II-IV (older children: 6 to \<18 years old) or Ross CHF classification II-IV (younger children: \< 6 years old)
* Systemic left ventricular ejection fraction ≤ 45% or fractional shortening ≤22.5%
* For Part 1 study: Patients must be treated with an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blockers (ARB) prior to screening. Patients in Group 1 and 2 must be currently treated with the dose equivalent of at least enalapril 0.2 mg/kg prior to the LCZ696 3.1 mg/kg administration. Group 3 patients will participate in LCZ696 0.8 mg/kg and not LCZ696 3.1 mg/kg.
* Biventricular physiology with systemic left ventricle

Key Exclusion Criteria:

* Patient with single ventricle or systemic right ventricle
* Patients listed for heart transplantation (as United Network for Organ Sharing status 1A) or hospitalized waiting for transplant (while on inotropes or with ventricular assist device)
* Sustained or symptomatic dysrhythmias uncontrolled with drug or device therapy
* Patients that have had cardiovascular surgery or percutaneous intervention to palliate or correct congenital cardiovascular malformations within 3 months of the screening visit. Patients anticipated to undergo corrective heart surgery during the 12 months after entry into Part 2
* Patients with unoperated obstructive or severe regurgitant valvular (aortic, pulmonary, or tricuspid) disease, or significant systemic ventricular outflow obstruction or aortic arch obstruction
* Patients with restrictive or hypertrophic cardiomyopathy
* Active myocarditis
* Renal vascular hypertension (including renal artery stenosis)
* Moderate-to severe obstructive pulmonary disease
* Serum potassium \> 5.3 mmol/L
* History of angioedema
* Allergy or hypersensitivity to ACEI / ARB