cyrilzakka/clinical-trials huggingface dataset:
Prediction of UA/SOD Ratio as a Biomarker of Oxidative Stress in Atrial Fibrillation

To clarify the predictive effects of uric acid and superoxide dismutase as biomarkers of oxidative stress on atrial fibrillation, and to provide greater value for the diagnosis and prediction of atrial fibrillation. It provides a new idea for the prevention and treatment of atrial fibrillation.

In recent years, a growing number of reports have shown the importance of oxidative stress in the pathophysiological mechanism of AF. During oxidative stress, there is an imbalance between the production of pro-oxidant reactive species and the antioxidant defenses of the cell, and excessive oxidation leads to oxidative damage and cell death. Redox processes can lead to atrial fibrosis and cardiac remodeling , suggesting that strategies to address myocardial oxidative stress may constitute a reasonable approach for the treatment of AF. However, few studies have reported the relationship between comprehensive oxidative stress-related biomarkers and AF. The purpose of this study was to illuminate the relationship of several blood markers of oxidative stress with AF and to provide new clues for the prevention and treatment of AF.

Eligibility Criteria:
Inclusion Criteria: This retrospective study enrolled all hospitalized patients from January 2018 to December 2020 at the Department of Cardiology in The First Affiliated Hospital of Shandong First Medical University. The diagnosis of AF was based on 12-lead electrocardiography (ECG) or 24-hour Holter monitoring, and classification was based on the published 2020 ESC guidelines for the diagnosis and management of AF.

Exclusion Criteria:

1. acute heart failure and acute myocardial infarction;
2. severe liver or kidney dysfunction (with aspartate aminotransferase or alanine aminotransferase levels three times higher than normal and estimated glomerular filtration rate \<30 ml/ (min\*1.73 m2));
3. malignant tumors;
4. missing data of laboratory indicators at baseline.
Leg Function and ADL After ALT Reconstruction for Head and Neck Cancer

Anterolateral thigh (ALT) free flap tissue transfer is a commonly used method of head and neck reconstruction after head and neck cancer removal. The procedure involves removing some muscle, skin, and tissue from the thigh, and this may affect leg function. The purpose of this study is to determine the impact of ALT on ambulation and activities of daily living (ADLs)

The ALT flap may be harvested as a subcutaneous, fasciocutaneous, musculocutaneous, or adipofascial flap. At our institution, three surgeons commonly use this method of free tissue transfer to reconstruct such defects. In our experience, patients following harvest of ALT flap have impairments in lower extremity function that result in decreased independence with transfers, gait and ability to independently perform ADLs. Consequently, these patients receive Physical and Occupational Therapy following surgery and a number of patients go on to receive therapy in a rehabilitation facility and/or as an outpatient. A number of studies have examined donor site morbidity and lower extremity function following ALT flap harvest. These studies, however, are heterogeneous and primarily use patient reported and non-standardized scales as outcome measures. Additionally, there is a paucity of literature related to Physical Therapy and Occupational Therapy outcomes and intervention with this patient population, despite frequent referral of these patients for post-surgical therapy.

This investigation will utilize the Lower Extremity Functional Scale, the Functional Independence Measure, dynamometry, video analysis of a single leg squat and walking speed in an effort to better assess the affect of ALT harvesting on patients' functional capacity post operatively. These tests are valid and reliable measures commonly utilized in Physical Rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

1. Over age 18;
2. Head and neck cancer;
3. To undergo anterolateral thigh free tissue transfer for head and neck reconstruction

Exclusion Criteria:

1. Inability to ambulate independently prior to surgery;
2. Inability to negotiate stairs prior to surgery;
3. Inability to follow simple commands;
4. Inability to negotiate stairs prior to surgery;
5. Previous free flap harvest from either lower extremity
White Coat Hypertension and Antihypertensive Treatment Effect - SCOR in Hypertension

To investigate the mechanisms of white coat hypertension and study it further as a risk factor for heart damage.

BACKGROUND:

The multidisciplinary SCOR examined causes, consequences, and treatments of human hypertension. A central theme was the renal basis for human hypertension. The subproject on white coat hypertension began in December of 1985.

DESIGN NARRATIVE:

In the longitudinal study, eighty patients with white coat hypertension were compared with 40 age- and sex-matched normotensives, and with 80 patients with sustained hypertension. The protocol consisted of (a) clinic blood pressure measurements made both by a physician and a nurse, (b) self-monitoring at home, (c) noninvasive ambulatory monitoring, (d) reactivity testing (cold pressor test, mental arithmetic, and isometric exercise) and (e) Korotkoff signal recording. Patients were also tested for early markers of disease (echocardiography and urine albumin).

The 80 patients in each of the two hypertensive groups were randomized to one of four treatment protocols (20 patients each); an alpha blocker, a beta blocker, a combined alpha- and beta-blocker, or an ACE inhibitor. The doses of medication were adjusted to produce similar reductions of clinic blood pressure in the different groups. The test battery (a-e) was reported during treatment.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Effect of Galacto-oligosaccharides (GOS) on Faecal Gut Microbiota in Adult Women

Within the Denali study the effect of 3 weeks intervention with GOS on the abundance of Bifidobacterium in faecal samples will be investigated.

This randomized, parallel, double-blinded intervention study of 6 weeks will include 88 females, who will consume GOS for three consecutive weeks. Faecal samples will be collected at several time points to measure microbiota composition.

Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy women
* Aged between 40 - 70 year
* Body Mass Index (BMI) between 18.5 - 30 kg/m2

Exclusion Criteria:

* Having a gastro-intestinal disease, such as celiac disease, Crohn's disease, Ulcerative colitis, or diagnosed irritable bowel syndrome;
* Having a history of intestinal surgery that might interfere with study outcomes. This does not include an appendectomy or cholecystectomy;
* Diagnosed with diabetes mellitus;
* Use of medication that may influence the study results, such as laxatives, lactase preparations, metformin, antibiotics, proton pomp inhibitors, antipsychotics, NSAID's (judged by our research physician);
* Self-perceived and diagnosed constipation;
* Having a food allergy to cow's milk or being lactose intolerant;
* Self-reported slimming, medically prescribed or other diets
* Reported weight loss or weight gain of \>5kg in the month prior to screening
* Use of (foods with) pre-, pro-, syn- and/or postbiotics\* (should be stopped at least 4 weeks before the start of the study), or other supplements that can influence the study results (to be determined by the medical investigator);
* History of side effects with the use of prebiotic supplements
* Use of antibiotic treatment less than 3 months before start of the study
* Pregnant or lactating (or having the wish to become pregnant during the study period, self-reported);
* Not able to comply with study procedures;
* Use of drugs (should be stopped at least 4 weeks before the study);
* Alcohol intake ≥7 glasses of alcoholic beverages per week, on average
* Participation in another clinical trial at the same time;
* Being an employee of the Food, Health \& Consumer Research group of Wageningen Food \& Biobased Research or employee of FrieslandCampina R\&D.
Combination of Trastuzumab and NK Immunotherapy for Recurrent Breast Cancer

The aim of this study is the safety and efficacy of Trastuzumab plus natural killer(NK) immunotherapy to recurrent breast cancer.

By enrolling patients who have breast cancer of Her-2 positive adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using Trastuzumab and NK cells.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 5 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
Nutritional Video Intervention Using Mindfulness-based Principles

The purpose of this study is to access the acceptability and potential utility of nutritional intervention videos in 1) changing knowledge and attitudes about healthy eating, 2) improving healthy food shopping practices, and 3) enhancing skills for stress reduction during food shopping among low-income Latina mothers.

* Low income Latina mothers (N=218) who are primary grocery shoppers for the family will be recruited through community based organization to take part in the study. Participation will include completion of survey instruments at baseline, immediately following the intervention; and a subset of participants (N=68) will also complete a 2-month follow-up survey and provide up to two weekly grocery store receipts from the prior 1-2 months at baseline and 2-month followup assessment points. The survey will collect data on demographics, knowledge about healthy eating, self efficacy, perceived stress and family history of relevant health issues. Grocery store receipts will be coded and used to evaluate pre-post changes in shopping of healthy vs unhealthy foods. The study compares two conditions: in the control condition, participants will view a 14-minute video on grocery shopping that teaches participants how to make healthy food choices. In the intervention condition, participants will view the aforementioned video in addition to a 15-minute video on how to manage stressors that arise during grocery shopping. -Surveys are to entered manually into chosen database by research assistant.
* 100% of data entries will be checked by Project specialist for accuracy.
* A total of 218 participants will be recruited to partake in the control condition Group A or Group B of the intervention.
* Because of the exploratory nature of the study, power calculations were not used to determine sample size.
* Group x time analyses will compare changes in knowledge, attitudes and self efficacy before and after exposure to the videos in the entire sample; and in the subsample followed for 2 months, compare baseline to 2-month followup changes in knowledge, attitudes, self efficacy, mindfulness and stress related measures as well as behavior change in food choices during grocery shopping.

Eligibility Criteria:
Inclusion Criteria:

* Identify as a Hispanic woman
* Ages: 18-55 years
* Responsible for buying groceries for family
* Language use: Ability to speak, read and write English or Spanish
* Resident in the USC's Health Sciences Campus and University Park Campus neighborhoods

Exclusion Criteria:

* None
Serplulimab Combined with Chemotherapy in Patients with Resectable Esophageal Squamous Cell Carcinoma

China with high incidence of esophageal cancer, the number of new cases and deaths account for about 50% of the world every year. In the past few decades, surgery, radiotherapy, chemotherapy and other treatments were continuously improved, however, the mortality of esophageal squamous cell carcinoma patients was not significantly decreased. For patients with locally advanced esophageal cancer, direct surgery is not effective. It is difficult to achieve radical resection by surgery merely, and even if many patients receive surgery, they may eventually have tumor recurrence and poor survival rate. Therefore, it is necessary to explore effective perioperative neoadjuvant treatment to reduce the risk of postoperative recurrence and improve the postoperative survival rate of patients. According to the reports, the expression of PD-L1 in esophageal cancer was about 41.4%. Therefore, PD-1/ PD-L1 immunocheckpoint inhibitor may become a new method for the treatment of esophageal cancer. Preliminary clinical results showed that immunotherapy combined with chemoradiotherapy provided a synergies antitumor effect. Multiple clinical results showed that serplulimab provided higher overall response rate for advanced esophageal cancer. However, in patients with locally advanced esophageal cancer, the efficacy of serplulimab combined with chemotherapy for sequential radical surgery is still unclear. The purpose of this study is to observe and evaluate the efficacy and safety of silulimab combined with chemotherapy in the neoadjuvant therapy of resectable esophageal squamous cell carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. signed informed consent;
2. patients age 18 to 75 years old
3. primary resectable, histologically confirmed esophageal squamous cell cancer;
4. Esophageal squamous cell carcinoma the clinical stage was IIA-IVA (according to AJCC TNM stage, 8th edition).
5. ECOG PS 0-1.
6. No distant metastasis, the diseases could be resectable assessed by thoracic oncologist;

Exclusion Criteria:

1. with significant cardiovascular disease;
2. current treatment with anti-viral therapy or HBV;
3. Female patients who are pregnant or lactating;
4. history of malignancy within 5 years prior to screening;
5. active or history of autoimmune disease or immune deficiency;
6. signs of distant metastases.
First In Human Study of CX-801 in Advanced Solid Tumors

The purpose of this first-in-human study, CTMX-801-101, is to characterize the safety, tolerability, and antitumor activity of CX-801 as monotherapy and in combination with pembrolizumab in adult participants with advanced solid tumors.

The study is comprised of 2 parts. Part 1 involves CX-801 dose escalation to identify the maximum tolerated dose (MTD) of CX-801 as monotherapy and as combination therapy (CX-801 combined with pembrolizumab). Part 2 (dose expansion) will further assess safety and tolerability as well as preliminarily assess antitumor activity of CX-801 combination therapy in indication-specific expansion cohorts.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic or locally advanced unresectable solid tumor that has progressed after standard therapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Measurable disease per RECIST v1.1
* Consent to fresh biopsy or if medically contraindicated, recent (within 6 months) archival tumor tissue
* Adequate organ function
* Additional inclusion criteria may apply

Exclusion Criteria:

* Recent history (within last 2 years) of localized cancers that are not related to the current cancer being treated
* Known active central nervous system (CNS) involvement by malignancy
* Prior immunotherapy discontinued due to grade 3 or higher immune related adverse event
* Systemic anticancer treatment within 4 weeks or 5 half lives prior to first dose of study treatment
* Investigational drug or device within 4 weeks prior to first dose of study treatment
* Radiation within 2 weeks prior to first dose of study treatment
* Serious concurrent illness
* Pregnant or breast feeding
* Additional exclusion criteria may apply
Effect of Oxygen in Normoxaemic COPD Patients Who Desaturate During Exercise

In COPD patients with desaturation during exercise, several studies have shown an acute beneficial effect of supplemental oxygen. Therefore, both the British Thoracic Society and the American Thoracic Society guidelines recommend supplemental oxygen to patients who desaturate \>4% and to below 88-90%. However, long-term studies have not been able to support this intervention. In this study of COPD patients, who desaturate and participate in a 7-week pulmonary rehabilitation programme, we examine the effect of supplemental oxygen on exercise tolerance, health status, and exacerbation rates. In a randomised design patients trained either with room air or with 2 litres oxygen per minute from a portable oxygen concentrator. All patients were asked to exercise every day for 30 minutes.

In COPD patients with desaturation during exercise, several studies have shown an acute beneficial effect of supplemental oxygen. Therefore, both the British Thoracic Society and the American Thoracic Society guidelines recommend supplemental oxygen to patients who desaturate \>4% and to below 88-90%. However, long-term studies have not been able to support this intervention. In this study of COPD patients, who desaturate and participate in a 7-week pulmonary rehabilitation programme, we examine the effect of supplemental oxygen. Using a randomised design, patients trained either with room air (control) or with 2 litres oxygen per minute from a portable oxygen concentrator. All patients were asked to exercise every day for 30 minutes.

Primary effect parameters:

endurance shuttle walk time at baseline, 7 weeks (after intensive supervised rehabilitation), 3 months (after maintenance training twice a month), and after 6 months.

Secondary effect parameters:

St. George Respiratory Questionnaire (health status); usage of oxygen, exacerbations requiring medical treatment, hospitalisation and mortality in the same periods.

Eligibility Criteria:
Inclusion Criteria:

* COPD
* participate in a 7-weeks pulmonary rehabilitation programme
* desaturate \>4% to less than 90% during endurance shuttle walk test

Exclusion Criteria:

* long-term oxygen therapy
Monitoring of Intracranial Hemorrhage in Non-severe Head Trauma Patients Hospitalized in the UHCD

The non-neurosurgical management of post-traumatic cerebral hemorrhagic lesions is currently poorly codified. It consists of neurological monitoring for 24 to 48 hours, and the performance of an almost systematic brain scan. Anti-aggregation and anticoagulation treatments are stopped for 14 to 28 days and should be resumed according to the risk-benefit ratio and the advice of the patient's treating physicians and cardiologists.

If the bleeding lesions do not progress, the patients are allowed to return home. If the lesions progress, the patients remain hospitalized for further monitoring, a new brain scan and neurosurgical advice.

This study seeks to show that the performance of systematic brain imaging in the absence of clinical deterioration of patients admitted to the UHCD for post-traumatic intracranial hemorrhage could be avoided, and thus to administer an unnecessary dose of irradiation to the patients, and would also have a significant financial stake.

Several recent studies have shown that there is no need to perform a follow-up brain scan in the absence of neurological deterioration, even in anticoagulated patients or those on antiplatelet drugs. Despite the growing number of articles, no recommendation or consensus has been proposed.


Eligibility Criteria:
Inclusion criteria:

* Adult patient (≥18 years old)
* Admitted to Emergency department of the Strasbourg University Hospital during the year 2017 (from 01/01/2017 to 31/12/2017)
* Patient having given his consent to the reuse of his data for the purpose of this research
* Hospitalized at the University Hospital for monitoring of a post-traumatic intracranial hemorrhage

Exclusion criteria:

* Patient having expressed opposition to participate in the study
* Non-isolated cranial trauma (MVA, fall greater than 6 meters ..)
* Subject under court protection
* Subject under guardianship or curatorship
Testing The Effectiveness Of Celecoxib In Patients With Painful Sore Throat

We are proposing a study in which we utilize and augment the sore throat pain model to assess the analgesic effectiveness of celecoxib compared to placebo in patients with painful pharyngitis under randomized, double-blind, placebo-controlled conditions.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have a diagnosis of pharyngitis with objective findings of tonsillo-pharyngitis.
* The patient is willing to take "nothing by mouth" including inhaled treatments except trial medication during the two hours while at the site and following trial drug administration (e.g. not smoking, food, drink, candy, lozenges, chewing gum). The patient will be allowed food and drink between hours 2 and 24, but no other oral or inhaled treatments such as smoking, lozenges, chewing gum. After the two hour assessment, the patients will be allowed food and drink within one half-hour following any hourly evaluations sore throat.

Exclusion Criteria:

* The patient has used any analgesic/antipyretic within 1 dosing interval preceding administration of the first dose of trial medication.
* The patient anticipates using any inhaled therapy including beta-agonists (e.g., ventolin) during the 24 hour trial period and, if used, has only used inhaled therapy on an intermittent basis in the week prior to the screening visit.