cyrilzakka/clinical-trials huggingface dataset:
Assess the Non-inferiority of GSK Biologicals' Mencevax™ ACWY (Manufactured by a New Process) vs Mencevax™ ACWY (the Already Existing Vaccine in the Market) When Given as a Single Dose to Subjects Aged 2-30 Yrs

The purpose of this study is to evaluate that the vaccine produced with the new process and administered as a single dose is at least as good as the existing Mencevax™ ACWY vaccine in terms of immunogenicity, safety and reactogenicity, in healthy subjects aged 2-30 years.

"Randomized study with four groups to receive one of the following vaccination regimens: - One of the 3 lots of GSK Biologicals' Mencevax™ ACWY vaccine manufactured by the new process (3 different groups) - GSK Biologicals' already existing Mencevax™ ACWY

Eligibility Criteria:
Inclusion criteria:

* Healthy male or female between 2 and 30 years of age at the time of vaccination.
* If the subject is female, she must be of non-childbearing potential. If a subject is a female of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after vaccination.

Exclusion criteria:

* Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of study vaccine, or planned use during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
* Vaccination with a meningococcal vaccine within the last five years.
* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 15 days before vaccine administration and ending 30 days after.
* History of or known exposure to meningococcal serogroup A, C, W135 or Y disease or contacts with subjects who had meningococcal disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
The Proton Pump Inhibitor (PPI) Test for the Extraesophageal Manifestation of GERD

PPI test;empirical trial with high-dose proton-pump inhibitors (PPIs) has been shown to be a sensitive tool for diagnosing patients with GERD. However, this diagnostic strategy has not been well established in patients with extraesophageal manifestation of GERD. In this study, we aim to see the relevance of PPI test in diagnosing GERD in patients with extraesophageal symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Patients with extraesophageal manifestation symptoms of GERD

Exclusion Criteria:

* laryngeal, pharyngeal, liver, lung, renal, or hematological disorders
* a history of gastrointestinal surgery, and a history of connective tissue disorders.
* patients with duodenal or gastric ulcers as well as other significant lesions, such as gastric cancer, esophageal cancer, or subepithelial tumors more than 1 cm observed on the upper endoscopy
Preventing Cognitive Decline with Metformin

A randomised control study of metformin in people with mild cognitive impairment and without diabetes mellitus to determine effects on cognitive decline and neuroimaging over 3 years.

A randomised placebo-control study of metformin in people with mild cognitive impairment and without diabetes mellitus to determine effects on cognitive decline, neuroimaging and biomarkers over 3 years.

Eligibility Criteria:
Inclusion Criteria:

* overweight or obese (body mass index \>25.0 kg/m2, waist: women\>80 cm, men\>94cm;
* Mild cognitive impairment (Mild Neurocognitive Disorder), based on DSM-5 criteria;
* Fasting blood glucose \<7.0 mmol/L and HbA1c \<6.5%;
* Able to undertake neurocognitive testing in English.
* Not participating in another trial of drugs or lifestyle modification to reduce cognitive decline.

Exclusion Criteria:

* Life-threatening illnesses to preclude participation in a 3-year study;
* Contraindications to the use of metformin (severe heart failure or eGFR \<40).
Evaluation of the Patient Safety Screening Tool (PSST) for Sepsis

The Patient Safety Screening Tool (PSST) for Sepsis solution is a tool to assist with the early detection of Sepsis and management of the administration of bundle packages as defined by the Institute for Healthcare Improvement (IHI). This web based application relies on integration with bedside medical equipment (BME) data as well as Lab and Registration data so that clinical workflow items can be automated in the fight against Sepsis.

The workflow that is automated by the PSST for Sepsis solution is tightly integrated with Registration, Bedside Monitoring Equipment (BME), and Lab data. As patients arrive in the unit, workflow activities are started with patient context. Typical implementations of the IHI guidelines for Sepsis screening dictate that patients are rescreened on regular intervals to detect Sepsis. The PSST for Sepsis solution will monitor Lab and BME data stores and continually update the screening forms for a particular patient. It will also alert clinicians when a manual screen is required in the Microsoft InfoPath form. The constant screening loop is managed by the PSST for Sepsis solution and will continue to run until the patient screens positive for Severe Sepsis, or moves to the next workflow of auditing a patient with Sever Sepsis.

When patients reach a state of "positive screen" (either manually, or through the automated data monitors) the PSST for Sepsis solution will move this patient from a screening workflow to an auditing workflow automatically. The PSST for Sepsis solution will then monitor the treatment process through Microsoft InfoPath form posts and alert clinicians when treatment goals have not been met. After a successful auditing process and completion of the 6 and 24 hour bundles, the patient will be placed back into a screening workflow. The end result is that patients will remain in a screening/auditing workflow loop until the patient is discharged from the unit.

Eligibility Criteria:
Inclusion Criteria:

* Patients that are hospitalized in the Neuro Care Unit (NCU)
* Patients that are hospitalized in the Vanderbilt Burn Center
* Patients must be \> 18 years of age

Exclusion Criteria:

* Patients \< 18 years of age
Modafinil to Prevent Postoperative Cognitive Decline

Postoperative cognitive dysfunction is a well-recognized complication of surgery. The aim of the study is to investigate whether cognitive dysfunction is reduced by the use of modafinil as shown by neurocognitive testing.The treatment effects will be evaluated compared to placebo as well as a non-surgical group.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists class I or II
* Elective surgery
* Surgery requiring general anesthesia

  4.) Control Group will be-females \& males 65 and older not scheduled for any surgical procedures for at least a 3 month period.

Exclusion Criteria:

* Neurosurgery
* Cardiac surgery
* Narcotic or illicit drug abuse
* Chronic opioid use
* Chronic use of anxiolytics
* History of pulmonary disease
* C02 retention
* Sleep apnea
* Obesity
Does Topical Steroid Treatment Impair the Adrenal Function?

The purpose of this study is to determine if topical steroids treatment for different skin diseases suppress the adrenal cortisol production.

Adrenocortical suppression is a potential complication of systemic corticosteroid treatement but also of non systemic therapy like topical therapy.

The normalcy of hypothalamic-pituitary-adrenal axis ( HPA axis) of patients with chronic skin diseases like atopic dermatitis, pemphigus or psoriasis which are treated with topical steroids, will be assessed with the low dose (1mcg) adrenocortocotropin ( ACTH) stimulation test. During this test serum cortisol levels are measured before, 30 and 60 mn after intravenous administration of 1mcg of ACTH (synacthen).The results will be compared with age and sex matched subjects with normal HPA axis as assessed by low dose ACTH stimulation test.

Eligibility Criteria:
Inclusion Criteria:

* patients receiving daily topical steroids for at least two weeks on 10% or more of body surface.

Exclusion Criteria:

* patients treated with any form of corticosteroids except topical steroids.
* patients with known pituitary disease
* pregnant patients
A Study of TCD601 in the Induction of Tolerance in Renal Transplantation (PANORAMA)

The purpose of this study is to determine the optimal regimen for the use of siplizumab, a human anti-CD2 antibody, combined with donor bone marrow cells and non-myeloablative conditioning, for tolerance induction in living donor renal transplantation


Eligibility Criteria:
Key Inclusion Criteria:

* Able to understand the study requirements and provide written informed consent before any study assessment is performed
* Male or female patients ≥ 18 to 65 years of age
* Recipient of a first renal transplant from a non-HLA identical, but at least haploidentical, ABO compatible living donor

Key Exclusion Criteria:

* Women of child-bearing potential, unless willing to comply with the use of highly effective methods of contraception as defined by the protocol
* A history of cancer other than basal cell carcinoma of the skin or carcinoma in situ of the cervix
* Recipient with anti-HLA donor-specific antibody (DSA)
An Expanded Clinical Study of Triple Therapy for Refractory Solid Tumors That Failed First-line Treatment for Recurrence and Metastasis

The clinical efficacy of chemotherapy /PD-1 monoclonal antibody/targeted therapy, chemotherapy /PD-1 monoclonal antibody/targeted therapy + noninvasive electromagnetic wave hyperthermia and chemotherapy /PD-1 monoclonal antibody/targeted therapy + noninvasive electromagnetic wave hyperthermia + autosomatic immunotherapy in the treatment of refractory refractory solid tumors with first-line treatment failure was compared.


Eligibility Criteria:
Inclusion Criteria:

1. Patients previously diagnosed with solid tumor by histopathology and/or cytology;
2. Aged 18 and 80, regardless of gender;
3. ECOG score of general physical condition was 0\~2;
4. The expected survival time is at least 3 months;
5. Patients with metastatic and recurrent tumors who failed conventional first-line therapy (including those above first-line therapy) and need to change treatment regimens;
6. According to RECIST standards, at least one measurable objective tumor index (spiral CT detection target lesion 10mm);
7. WBC 3.0109 /L Hb 90g/L PLT 75.109 /L at baseline upon enrollment;
8. Normal liver function a) Liver: total bilirubin 2.0 mg/dL(34.2umol/L), 2.5 times the upper limit of AST and ALT, 5 times the upper limit of AST and ALT in patients with liver metastasis b) Kidney: Creatinine 2.5 mg/dL(221umol/L), creatinine clearance rate 60 mL/min;
9. Understand and sign informed consent and voluntarily participate in clinical research

Exclusion Criteria:

1. severe active infection and other serious complications;
2. Patients with a history of autoimmune diseases, including but not limited to multiple sclerosis, systemic lupus erythematosus, inflammatory bowel disease, scleroderma, excluding vitiligo;
3. Prednisone can be used in patients with systemic corticosteroid or other immunosuppressive hormone therapy. 0.5 mg/kg/day (maximum cell count group 40 mg/day) or other similar drugs in the same cell count group, inhaled corticosteroids for chronic obstructive pulmonary disease (COPD) or topical administration;
4. patients who have undergone major organ transplants;
5. Patients in the active stage of viral hepatitis;
6. Patients with coagulation dysfunction;
7. have uncontrolled congestive heart failure or hypertension, unstable heart disease (coronary artery disease or myocardial infarction) or uncontrolled arrhythmia;
8. Pregnant or lactating women.
9. symptomatic brain metastases or mental disorders;
10. Participated in clinical trials of new drugs within 4 weeks before enrollment;
11. If the patients are randomly assigned to the hyperthermia treatment group, they need to refer to the exclusion requirements of hyperthermia (the hyperthermia site contains metal or thermal implant, skin allergy to heat, and body position cannot cooperate).
12. Other factors considered by researchers are not suitable for candidates.
Association of Inflammatory Markers with Preoperative Anxiety and Agitation

This study was planned as a prospective, observational study. The study will include pediatric patients aged 3-12 who will undergo surgery. Our hypothesis is that haemogram parameters, which are a simple, cheap and accessible method, and the inflammatory markers we obtain from them are associated with preoperative anxiety and emergence delirium

Inclusion criteria for the study: Pediatric patients aged 5-12 years, in the ASA I-II groups, who will undergo surgery in ophthalmology, urological surgery, ENT surgery, pediatric surgery, orthopedic and plastic surgery. Exclusion criteria for the study can be listed as follows: Those with genetic diseases affecting brain development, those diagnosed with psychiatric and neurological diseases, patients with attention deficit, mental retardation, those with hematological and/or immune system disorders, patients who will undergo surgery in neurosurgery and cardiovascular surgery.

During the preoperative visit, parents and children will be informed and their written and verbal consent will be obtained. Patients will be taken to the preoperative waiting room and hemogram values and ratios (WBC, RBC, Hematocrit, Monocyte count, Neutrophil count, Lymphocyte count, Platelet count, PDW, MPV, MLR, NLR, NMR, PLR, PMR, PNR, PWR, SII) will be recorded from medical records. Demographic data (including age, gender, BMI, ASA score, fasting time, previous surgery, hospitalization status, the use of steroid), preoperative anxiety score (to be assessed with m-YPAS Turkish version), parental accompaniment, anxiety score of the parent (to be assessed with Likert scale), preoperative medication application, medications used in anesthesia, airway device, surgery and anesthesia durations will be recorded. The PAED score will be used for delirium agitation and all values will be recorded during the first 30 min. Pain scores (FLACC and VAS) will be recorded in the case report form.

Eligibility Criteria:
Inclusion criteria:

* Pediatric patients aged 5-12 years
* ASA I-II groups
* Pediatric patients who will undergo surgery in ophthalmology, urological surgery, ENT surgery, pediatric surgery, orthopedic and plastic surgery.

Exclusion criteria:

* Those with genetic disorders affecting brain development
* Those diagnosed with psychiatric and neurological diseases
* Patients with attention deficit, mental retardation
* Patients with hematological and/or immune system disorders
* Patients who will undergo surgery in neurosurgery and cardiovascular surgery.
A 6 Week Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of GK1-399 in Type 2 Diabetes

The purpose of this trial is to study the drug levels and biomarkers in the body and the safety of an investigational drug (GK1-399) in patients with Type 2 diabetes. Patients in the study will receive placebo for 1 week followed by 1 of 4 treatments for 6 weeks. One of the 4 treatments will be placebo, which does not contain an active ingredient. The study participation includes in-patient and out-patient days.


Eligibility Criteria:
Inclusion Criteria:

* Be male or female, aged 18 through 75 years at screening.
* Have a diagnosis of Type 2 Diabetes Mellitus (T2DM)
* On a stable dose of background medication for the treatment of diabetes
* Body Mass Index (BMI) between 20-40 kg/m2 (inclusive)

Exclusion Criteria:

* Subjects with type 1 diabetes, heart attack or stroke in the past 6 months, uncontrolled blood pressure, significant kidney disease
The Effect of Clinic Visit Audio Recordings for Self-management in Older Adults

The objective of this study is to conduct a multisite trial evaluating the impact of adding an audio recording of clinic visits (AUDIO) to usual care in older adults with multimorbidity, including diabetes, compared to After Visit Summary (AVS) alone (Usual Care; UC).

The objective of this study is to conduct a multisite trial evaluating the impact of adding an audio recording of clinic visits (AUDIO) to usual care in older adults with multimorbidity, including diabetes, compared to AVS alone (Usual Care; UC). The specific aims are: Aim 1 Conduct a three-site trial in primary care where older patients with multimorbidity including diabetes (n=336) will be randomized to receive an audio recording as well as AVS (AUDIO) versus AVS alone (UC) for all scheduled clinic visits over 12 months; patients will be assessed at baseline, 1 week, 6 months and 12 months. Applicants hypothesize (Main Effect) that: compared to those receiving UC, patients randomized to also receive audio recordings (AUDIO) of clinic visits will report a greater self-management ability (Primary Outcome), with improved quality of life, medication adherence, and satisfaction (Secondary Outcomes) at 12 months.

Eligibility Criteria:
Patients participants:

Inclusion Criteria:

* Patients who are ≥ 65 years;
* Patients with multimorbidity (i.e. patient has diabetes and one or more chronic conditions including: arthritis, asthma, atrial fibrillation, cancer, chronic obstructive pulmonary disease, heart disease, depression, heart failure, hypertension, osteoporosis, kidney disease and stroke);
* Have had two or more clinic visits in the previous 12 months;
* Plan on receiving ongoing care at the clinic for the subsequent 12 months;
* Do not have any vision or hearing problems that cannot be corrected;
* Have not recorded a clinic visit for personal use i the past 6 months.

Exclusion Criteria:

* Without capacity to consent to the project;
* With schizophrenia and other psychotic disorders, substance-use disorders, uncorrectable hearing or visual impairment or a six item screener (SIS) cognitive function score ≤ 4;
* Living in skilled nursing homes or hospice;
* Patients who have audio- recorded a clinic visit for their personal use in the previous six months;
* Patients who do not speak English or Spanish;
* Patients who lack internet access;
* Patients who (a) do not have access to a personal email, (b) do not have an email address shared with a family member or patient-identified caregiver, and (c) are not interested in creating an email account between the time they are first contacted by the study team to the time that the study team requires an email address to initiate the online recording software registration.

Clinician participants:

Inclusion criteria:

* Licensed clinician (MD, DO, APRN, NP, PA)
* Are based at the study clinic;
* Who treat adult patients.

Exclusion criteria:

* Are trainees, e.g., fellows, medical students or residents;
* Commonly audio or video record clinic visits for patient's personal use.
Interscalene Brachial Plexus Block Washout to Reverse Inadvertent Phrenic Nerve Blockade

One of the most frequently performed peripheral nerve blocks (the injection of local anesthetic near nerves to block sensation/ movement to a specific part of the body) is the interscalene brachial plexus block for upper extremity surgeries. This type of block can unmask underlying respiratory issues such as shortness of breath due to a well-known and typically insignificant side effect of temporary diaphragmatic paralysis.

The nerve block may be able to use saline solution to wash out the local anesthetic and potentially reverse this respiratory side effect. Specifically, the goal of this study is to determine if the injection of saline through the nerve block catheter reverses blockade of the phrenic nerve supplying the diaphragm, without affecting the ability of the nerve block to provide pain control after surgery.


Eligibility Criteria:
Inclusion criteria:

* All adult patients (18 years and over) scheduled for surgery requiring a continuous interscalene brachial plexus nerve block catheter as part of their anesthetic care.

Exclusion criteria:

* Concomitant life-threatening injuries and other concomitant injuries causing significant pain
* Pregnant
* Any condition impairing patient's ability to consent to participation in study, and an existing condition contraindicating a nerve block, i.e. nerve injury, existing bleeding disorder, infection in the vicinity of the block, and patient refusal.
Anti-psychotic Drug Prescribing Patterns Within Specialist Adult ID Services in England and Wales

The overall aim of this observational study is to establish the anti-psychotic prescribing patterns across specialist intellectual disability (ID) services in England and Wales by collecting cross-sectional retrospective data at 7 annual time-points (1st July) from 2017 to 2023.

Feasibility protocol objectives:

1. Is it feasible to identify People with Intellectual Disabilities (PwID) who have been prescribed 2 or more anti-psychotic medications over 7 years retrospectively.
2. It is possible to obtain a complete data set for each patient identified and therefore be able to explore the prescribing patterns across the eight sites.
3. Is it feasible to quantify anti-psychotic treatment (APT) prescribing in PwID as chlorpromazine equivalent dose values across different healthcare Trusts in England and Wales.

   Main objectives:
4. To explore yearly and overall prescribing patterns among PwID (with or without mental-health reasons (psychiatric co-morbidities)) in receipt of ≥2 forms of anti-psychotic treatment (multiple) over time?
5. How has multiple anti-psychotic treatment prescribing changed between 2017 and 2023 using chlorpromazine equivalent dose values, in PwID with mental health and no mental health indications?
6. What has been the impact of the COVID-19 pandemic (and corresponding lockdown restrictions in England and Wales) on multiple anti-psychotic treatment prescribing among PwID?
7. Can the NHS England Statistical Process Control tool (SPC) be utilised to track yearly anti-psychotic treatment prescribing among PwID receiving multiple forms of anti-psychotic treatment, and monitor variation between services (sites) and patient groups (e.g. psychiatric co-morbidities; challenging behaviour).

Eligibility Criteria:
Inclusion Criteria:

* Patient had psychiatric review by specialist adult ID services in the last year (e.g. for a patient to be included at 1st June 2017, data to be recorded from the most recent psychiatric review within the period between 1st January 2017 - 31st December 2017).
* Patient has a diagnosis of ID
* Patient under the care of specialist adult ID services
* Patient on \>2 anti-psychotic treatments (oral and IM injectable (depots))

Exclusion Criteria:

* Patients treated with Clozapine
* Under the age of 18 years
Phototherapy in Persons With Multiple Sclerosis

The current study examines the effect of phototherapy equipped with Narrow Band UVB lamps on vitamin D production in persons with MS.

Participants will be exposed to phototherapy according to the 2014 Guidelines issued by the American Academy of Dermatology 3 days per week over an 8-week period.

Eligibility Criteria:
Inclusion Criteria:

* Female with multiple sclerosis

Exclusion Criteria:

* Inability to stand still in a stabilized fashion without risk of falling for up to 6 minutes
* Known medical history of calcium disorder or knowledge of high calcium levels
* Known medical history of hyper-parathyroidism
* Current supplementation with oral vitamin D
* Known allergy to vitamin D
* History of cancer of any type including but not limited to skin cancer
* Obesity defined as BMI \> 30
* Known history of fat malabsorption conditions (i.e., steatorrhea)
* Current use of anti-epileptic medication
* Current use of glucocorticoids
* Fitzpatrick skin types I and VI using the Fitzpatrick skin type analysis
* Recent use of tanning facilities