cyrilzakka/clinical-trials huggingface dataset:
Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma

To explore the control rate and quality of life of participants with late head and neck squamous cell carcinoma who have obtained postoperative pCR after cervical lymph node surgery with neoadjuvant chemotherapy combined with immunotherapy, and the cervical lymph node removal prophylactic irradiation ENI in the low-risk area.

In order to understand whether it can better protect normal tissues such as pharyngeal constriction muscles, thyroid, parotid glands, and submandibular glands without affecting the efficacy of tumors, and reduce the negative impact of radiotherapy on immunotherapy, the investigators plan to conduct a prospective phase II study to explore the control rate and quality of life of patients with late head and neck squamous cell carcinoma who have obtained postoperative pCR after cervical lymph node surgery with neoadjuvant chemotherapy combined with immunotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Preoperative pathologically confirmed initial treatment of head and neck squamous cell carcinoma
* Receive neoadjuvant chemotherapy combined with PD-1 monoclonal antibody immunotherapy, and meet one of the following conditions: Preoperative clinical stage was T3-T4 or N2-N3 (AJCC 8th edition). Patients with oral cancer/oropharyngeal cancer had positive lymph nodes in the IV/V region with imaging diagnosis or biopsy confirmation before surgery. HPV/ P16-positive oropharyngeal cancer patients with clinical lymph node invasion (ENE), one positive cervical lymph node \> 3cm or multiple positive cervical lymph nodes before surgery
* The pathology of at least one cervical lymph node was determined by pCR；
* Karnofsky's physical status score ≥70 points；
* Age: 18 \~ 70 years old；
* Laboratory examination results within 1 week before enrollment met the following conditions: neutrophils (ANC) ≥1.5×109/L, platelets (PLT) ≥ 75×109/L
* Patients participate voluntarily and sign informed consent forms.

Exclusion Criteria:

* Previous head and neck radiation treatment
* Severe complications；
* Pregnant or lactating women
* Who were deemed unsuitable for inclusion by the researchers.
Addressing Antihypertensive Medication Adherence Through EHR-enabled Teamlets in Primary Care

The study team will conduct a cluster randomized control trial in 10 NYU primary care practices to assess the effectiveness and implementation of the multicomponent intervention on medication adherence and blood pressure control for patients who are non-adherent to antihypertensive medications.


Eligibility Criteria:
Inclusion Criteria:

Individuals:

1. Age\>18 years
2. Presence of Hypertension as defined by either:

   1. Blood pressure ≥140/90
   2. Hypertension diagnosis
   3. Prescription for at least one antihypertensive medication
3. Outpatient clinic visit in the NYULH between 06/1/2022 and 12/31/2025

MAs, PCPs, LPNs, and RNs:

1. A clinician from an NYULH ambulatory practice location.

   a. Eligible clinicians include physicians, medical assistants, licensed practical nurses, and registered nurses.
2. Adult patients during appointments with eligible clinicians
3. Age \> 18 years

Exclusion Criteria:

1. Patients who decline to be observed.
2. The study team has no specific exclusion criteria for patients in chart review.
Multi-center Study to Examine Changes to the Environment Surrounding the Electrodes in the Cochlea and to Capture the Most Challenging Listening Environments Experienced by Persons with a Cochlear Implant

This early feasibility study aims to collect pilot data on impedance measurements in real-world environments and to collect real-world and difficult listening situations and the factors impacting this, reflecting situations the subjects encounter during their daily life outside of the clinic. Improving the monitoring of both aspects may lead to improvements in monitoring and personalising the fitting to optimise hearing outcomes for persons with a cochlear implant.

This is a feasibility, prospective, multi-country, multi-centre, cross-sectional interventional clinical investigation in adults with a CE labelled cochlear implant.

No Randomisation nor blinding to avoid bias is applicable in this study since there is no comparator.

Subjects will attend two scheduled study visits over a two-month study period. At and in between study visits, subjects will undergo hearing assessments and safety monitoring. The subjects will perform daily impedance test tasks and complete a questionnaire in order to obtain the first primary endpoint, i.e. characterization of Daily Impedance Fluctuations.

Furthermore, the subjects will do EMA tasks to obtain the secondary objectives to capture daily-life, real-world listening environments and challenging listening environments.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older (no upper age limit).
* Implanted with CIC4-based implant with a Contour Advance, Slim Straight or Slim Modiolar electrode array with at least 6 months experience.
* Candidate is a fluent speaker in the language used to assess speech perception performance, as determined by the investigator.
* Willing and able to provide written informed consent.

Exclusion Criteria:

* Score below 3 on the screening subset of questions from the Mobile Device Proficiency Questionnaire (digital literacy check).
* A failed ECE1 or ECE2 (i.e. flagged, open circuit or short circuit)
* Additional health factors, known to the investigator, that would prevent or restrict participation in the evaluations, including significant visual impairment and/or dexterity issues.
* Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
* Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
* Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
* Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation)
Metabolomic Signature of Exogenous Ketosis

Ketone bodies are a fuel source and signaling molecule that are produced by your body during prolonged fasting or if you consistently eat at low-carbohydrate diet. Blood ketones can be used as a source of energy during fasting and are used by your brain as an alternative source of fuel to glucose. Previous studies have found that ketones, when consumed in form of a supplement drink, can increase blood ketone levels and lower blood glucose, the amount of sugar in your blood. This is of potential interest for individuals with high blood sugar, such as people living with type 2 diabetes. However, how ketone supplements impact metabolism is not fully understood but using high throughput analysis techniques that can characterize hundreds to thousands of metabolites in the blood (known as "metabolomics") may allow researchers to discover novel compounds within the body that are altered by ketone supplements. This will improve our understanding of how ketones impact metabolism and guide future research.


Eligibility Criteria:
Inclusion Criteria:

* over the age of 18 years
* able to fast overnight

Exclusion Criteria:

* being a competitive endurance athlete
* following a ketogenic diet, low-calorie diet, periodic fasting regimen, or regular consuming ketone supplements
* being unable to travel to and from the university
* being pregnant or planning to become pregnant during the study
* having been diagnosed with a chronic disorder of glucose or fat metabolism, including type 2 diabetes, chronic pancreatitis, or gallbladder disease
* being unable to read or communicate in English
Influence of Radiotherapy and Chemotherapy in the Value of Peripheral Blood Lymphocyte Subsets Among Thoracic Cancer

This study is an observation, single center study to evaluate the alternations and prognostic value of peripheral blood lymphocyte (PBL) in patients diagnosed with thoracic cancers, including lung cancer, esophageal squamous cell carcinoma and thymic epithelial carcinoma underwent radiotherapy with or without chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

Age at least 18 years. ECOG PS 0-1. Pathologically confirmed NSCLC, esophageal squamous cell carcinoma or thymic epithelial tumor.

Life expectancy of more than 3 months. Patients with no indications for palliative radiotherapy in the opinion of the investigator.

Patients with a prior history of surgery are eligible if they have recovered adequately from the toxicity and/or complications of surgery.

Signed informed consent for the use of fresh tumor biopsies before and during the treatment.

Women of childbearing age and men must agree to use effective contraception during the trial.

Adequate organ function within 1 week prior to the enrollment：

1. Adequate bone marrow function: hemoglobin ≥80g/L, white blood cell (WBC) count ≥ 4.0 \* 10 \^ 9/L or neutrophil count ≥ 1.5 \* 10 \^ 9/L, and platelet count ≥ 100 \* 10 \^ 9/L;
2. Adequate hepatic function: total bilirubin \< 1.5 x upper limit of normal (ULN). Note: If total bilirubin is \> 1.5 x ULN, direct bilirubin must ≤ ULN, Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.5 ULN;
3. Adequate renal function: serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min;

Exclusion Criteria:

Pregnant or lactating women. History of any other malignancy. Patients in whom palliative radiotherapy is indicated in the opinion of the investigator.

Active infection, congestive heart failure, myocardial infarction within the 6 months prior to enrollment, unstable angina pectoris or cardiac arrhythmia.

Patients who have received tumor vaccine; or administration of live, attenuated vaccine within 4 weeks before the start of treatment.

Mental disorders, drug abuse, and social condition that may negatively impact compliance in the opinion of the investigator.
The Effect of Dexamethasone on the Duration of Interscalene Nerve Blocks With Ropivacaine or Bupivacaine

This study will test the hypothesis that adding dexamethasone significantly prolongs the duration of ropivacaine and bupivacaine analgesia, and that the magnitude of the effect differs among the two local anaesthetics.. Participants will be patients undergoing shoulder surgery with an interscalene nerve block.

This is a double-blinded randomized study of four groups of patients undergoing shoulder surgery using interscalene nerve blocks. Participants will be randomized into one of four groups:

* Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (placebo) for interscalene block;
* Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline (placebo);
* Ropivacaine and steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic;
* Bupivacaine and steroid: 30 ml 0.5% bupivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic.

The primary outcome is the duration of the interscalene nerve block which is time to first analgesic request after PACU discharge.

Kaplan-Meier survival density estimation and stratified Cox proportional hazard regression were used to compare groups.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75 years
* Patients undergoing shoulder procedures, such as rotator cuff repair, capsular shift, shoulder arthroplasty, subacromial decompression

Exclusion Criteria:

* Contraindications to interscalene block (Coagulopathy, infection at the needle insertion site, moderate to severe chronic obstructive pulmonary disease, contralateral pneumothorax or diaphragmatic paralysis)
* Pregnancy
* Pre-existing neuropathy involving the surgical limb
* Systemic glucocorticoid treatment (for 2 weeks or more) within six months of surgery
* Chronic opioid use (greater than 30 mg oral oxycodone equivalent per day)
Influence of Aerobic Exercise Training (AET) on Inflammatory Bowel Disease (IBD) in Children and Adolescents

The purpose of this study is to determine if aerobic exercise training can serve as comprehensive palliative care, whereby enhancing cardiovascular fitness, mitigating depressive symptoms and augmenting sleep while bolstering health related quality of life in youth with Crohn's Disease and Ulcerative Colitis.

An AET intervention is designed to increase the aerobic fitness levels of IBD sufferers through daily activity, which is notably lower in this population and could be beneficial for sufferers managing this lifelong disease. With an increase in physical activity, the exergame aims to introduce, instill and integrate daily physical activity in the lives of IBD sufferers. The Just Dance Kids exergame for Nintendo Wii employs moderate intensity physical activity and is well suited for this study. The exergame intervention protocol will comprise a ramped duration aerobic exercise training starting with 10 minutes in week 1 and rises to 30 minutes per session in weeks 5 through 8. Just Dance Kids will be used by participants under the age of 11 and Just Dance for participants over the age of 10 due to the age appropriate dancing skill required in each game. The aim is to determine if this moderate intensity, 5 times per week exercise could decrease IBD flare-ups, improve cardiovascular fitness, reduce depressive symptoms, improve quality and quantity of sleep and improve the health-related quality of life in children and adolescents with IBD.

Eligibility Criteria:
Inclusion Criteria:

* aged 7 through 20 at start of study
* willing and able to volunteer in the study
* able to communicate and to complete questionnaires in German
* have a functioning television with Nintendo Wii compatibility at home
* provide participant written informed consent (when ≥11 years old at start of study)
* provide parental/legal caregiver written informed consent (when participant is ≤17 years old at start of study)
* provide oral informed consent (when ≤10 years old at start of study)

Exclusion Criteria:

* refusal to give necessary oral or written informed consent by patient and/or parent (legal caregiver)
* not aged 7 through 20 at start of study
* not willing and able to volunteer in the study
* has sibling enrolled in this study
* has severe physical diseases of the locomotor apparatus, psychotic disorders, severe affective disorders, eating disorders, mental retardation, autism spectrum disorder
* inability to communicate and complete questionnaires in German
* does not own a functional and Nintendo Wii-compatible television at home
* among female adolescents, pregnancy, breastfeeding or intention to get pregnant during the study
* has clinically significant cardiovascular disease
* enrolment of the investigator, his/her family members, employees and other dependent persons
A Study to Measure the Effect of a Toothpaste Containing Proteins and Enzymes and a Fluoride Toothpaste on Gingival Health

This study is a double-blind, randomised, parallel group efficacy study. A minimum of 240 healthy female and male participants aged 18-70 years will be enrolled onto the study according to the inclusion/exclusion criteria. The accepted participants will then be randomly allocated to one of the two test products which they will use at home, twice a day for the duration of the study. Dental assessments of gingival condition and plaque level will be conducted after 4, 13 and 26 weeks of product use at the study site.


Eligibility Criteria:
Inclusion Criteria:

* Be in good general health.
* Be willing and physically able to carry out all study procedures.
* Be willing and competent (verbally and cognitively) to give written informed consent and complete a medical history form.
* Have at least 20 natural teeth without subgingival calculus including 5 teeth (excluding 3rd molars) in each quadrant, which can be assessed.
* Have mean Gingival Index (GI) score between 1.0 and 2.0 (1.0 ≤ Mean GI ≤ 2.0) and mean Plaque Index (PI) ≥ 1.5 at screening and baseline.
* Not have had a scale and prophylaxis in the month prior to enrolment or have one scheduled prior to the end of the study.
* Be willing to use only the test products for 6 months, after brushing with the products on site.
* Brush teeth twice daily (once in the morning and once at night).

Exclusion Criteria:

* Pregnant or breast feeding mothers.
* Subjects who participated in gum health study within 3 months prior to screening.
* Current participation in any other cosmetic trials, any dental clinical trials or clinical trials.
* Subjects who have used gum health products in the 4 weeks prior to screening.
* Obvious signs of untreated caries or significant periodontal disease, which in the opinion of the study dentist, will affect either the scientific validity of the study or if the participant was to participate in the study would affect their wellbeing.
* Full or partial dentures wearers.
* Current orthodontic treatment.
* Smokers or those who have a recent smoking history, including e-cigarettes.
* Diabetics.
* Medical condition and/or regular use of any medication which might affect the outcome of the study, as determined by the study dentist, principally a course of anti-inflammatory, antimicrobial or statin drugs within 4 weeks of screening.
* Taking dietary supplements (e.g. multivitamins, antioxidants, fish oils, etc.).
* Vegetarians and Vegans.
* Allergic to any ingredient of study products.
* The subject is a Unilever employee or a member of the study team.
* Any participant who, in the judgement of the investigator, should not participate in the study.
Randomized Controlled Trial to Compare Two Anti-scorpion Serums

The purpose of this study is to compare the efficiency and safety of the treatment against sting scorpion, using two serums, one elaborated by Birmex versus other commercial serum

We consider relevant conduct this study because the poisoning scorpion bite represents a public health problem.

This is a randomized clinical trial, which included 120 subjects of both sexes aged 15 and 60 years old and residents of the state of Guanajuato, divided into 2 groups: 60 patients received antiscorpion serum of Birmex and 60 patients receive other commercial serum.

Eligibility Criteria:
Inclusion Criteria:

* Sting scorpion
* Informed consent
* Age 15-60
* Either sex
* Resident in study area

Exclusion Criteria:

* Previous treatment with gammaglobulin
* Blood transfusion at any stage of life
* Sensitivity or intolerance to serums antiscorpion or horse products
* Pregnancy
* Some immunodeficiency
Comparison of Epidural and Paracostal Catheter Placement for Pain Control After Rib Fractures

The investigators plan to compare the incidence of successful placement of epidural pain catheters versus paracostal catheters for the control of pain and prevention of pulmonary complications for adult trauma patients with blunt chest wall trauma resulting in multiple rib fractures. When a trauma patient has \> or = to 3 rib fractures on the same side, is being admitted to the Surgical ICU, and is encountered within 72 hours from the time of their injury, they will be eligible for the study. If they (or a proxy) choose to participate, consent will be obtained and they will randomly be assigned to receive either an epidural or paracostal catheter for pain control. The aim of the study is to determine if paracostal catheters are noninferior to epidurals for controlling pain in multisystem trauma patients. Secondarily the investigators will evaluate success and time of placement of the assigned intervention and follow the patient throughout their hospital course to compare the success of analgesia provided by each modality along with any complications and/or benefits of the two types of catheters.


Eligibility Criteria:
Inclusion Criteria:

* \>/= 3 rib fractures on a single side
* Admitted to the Surgical ICU
* Recruited within 24 hours of admission

Exclusion Criteria:

* Patient allergy to local anesthetics
* Patient refusal
* Inability to consent for any reason
* Prisoners
* Age \< 18
* Pregnant women (pregnancy screen performed as part of routine trauma admission labs)
* Absolute contraindications for either thoracic epidural or paracostal pain catheter placement which include:

  1. Localized rash or skin infection over the likely site of insertion (We never want to translocate infectious material from the skin to the epidural space or even into the soft tissue where paracostal catheters lay, although for these there is more flexibility in adjusting placement)
  2. Spinal/vertebral instability/fracture including any significant vertebral body injury and 3 or more spinous process fractures near the level of desired epidural placement (transverse process fractures are not considered a contraindication)
  3. History of extensive back surgery at the level of desired epidural placement
  4. Severe aortic stenosis, mitral stenosis, or pulmonary hypertension
  5. Inability to correct coagulopathy (to International Normalized Ratio\>1.5)
  6. Persistent hemodynamic instability (hypotension with Systolic Blood Pressure\<90 that does not respond to initial fluid boluses and requires ongoing pressors beyond the 72 hour window for enrollment)
  7. Inability to cooperate and participate in placement (if intubated and sedated, for example) or to lie in the correct position for placement (lateral decubitus for paracostal pain catheters, either sitting up or lateral decubitus for epidural placement)
  8. Concern for elevated intracranial pressure (we imagine these patients will also be intubated)