cyrilzakka/clinical-trials huggingface dataset:
Nitrate Supplementation on Motor Unit Activity

This study aimed to assess if nitrate supplementation influence motor unit (MU) activity following a sustained ischemic contraction and whether this is affected by blood flow restriction (BFR) during the recovery period. Fourteen male participants (mean ± SD, 25 ± 6 years) completed two experimental trials following 5-days of supplementation with either nitrate-rich (NIT) or nitrate-depleted (PLA) beetroot juice in a randomized, double-blinded, cross-over design. Intramuscular electromyography was used to assess MU potential (MUP) size and firing rates (MUFR) during a submaximal (25% MVC) sustained isometric contraction with BFR. These variables were also assessed during a 90 s recovery period with the first half completed with, and the second half completed without, BFR. Nitrate supplementation can expedite the recovery of MUP duration following a sustained ischemic contraction in healthy adults. These novel observations improve understanding of the effects of nitrate on the recovery of neuromuscular function post-exercise and might have implications for recovery of muscle contractile function.


Eligibility Criteria:
Inclusion Criteria:

* Male between 18 - 30 years
* free from known respiratory insufficiency, cardiovascular disease and neuro-musculo-skeletal problems at present or in the preceding 6 months.
* having at least 5 years competitively (team) sport experience.

Exclusion Criteria:

* having cardiovascular disease, neuromuscular disease and any lower limb injury and treatment for chronic respiratory complaints.
Comparison of Nutrition Education Alone or With Acupuncture for Weight Loss in Breast Cancer Patients Post-Chemotherapy

This study looks at the benefit of adding acupuncture to nutrition education for weight loss in women with early stage breast cancer post-chemotherapy.

Obesity and weight gain are significant concerns for breast cancer survivors. Given the adverse consequences of weight gain after diagnosis, continued efforts to identify appropriate weight management interventions aimed at promoting overall health and long term survivorship are needed. In this study, the investigators will examine whether adding acupuncture to a nutrition education program for weight loss could improve short and long term weight loss among breast cancer survivors post treatment with chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Woman with a diagnosis of breast cancer, stage I, II, or III
* Age ≥ 18
* ECOG performance status ≤ 1
* Received treatment for breast cancer, and treatment must have been completed at least 2 weeks prior to enrollment in trial, but no longer than 1 year post-treatment.
* BMI ≥ 30
* Adequate bone marrow and organ function as determined by the consenting/enrolling investigator
* Signed informed consent
* Any receptor status
* Participant is willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled visits, and examinations

Exclusion Criteria:

* Current chemotherapy or radiation therapy. Participants in study may still be receiving hormone or Herceptin treatment.
* Diagnosis of metastatic breast cancer
* Participation in other diet-based weight loss programs (ie. Patient should not be currently enrolled in Weight Watchers, Jenny Craig, Nutrisystem, etc.)
* Current use of commercial or natural/herbal weight loss supplements
* Major surgery within 1 month of starting study program and patients must have recovered from any effects of major surgery
* Other malignancies within the past three years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
* Personal history of an eating disorder
* Other serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled infection (including uncontrolled HIV, Hepatitis B or C), or any psychiatric disorder that prohibits obtaining informed consent
Effects of Soy Isoflavone on Bone Health Among Saudi Female Students Imam Abdulrahman Bin Faisal University.

Low bone mineral density (BMD) has recently increased among young women. Soy Isoflavone as a food supplement, has been found to have potent effect on bone health in postmenopausal women. However, the effect of soy isoflavone on pre-menopausal is not well understood. This research is done to examine the effect of soy isoflavones on BMD among young university female students.


Eligibility Criteria:
Inclusion Criteria:

* female
* University students
* aged between 18-25 years

Exclusion Criteria:

* Study participants who use medications and suffer from diseases that may interfere or effect on BMD, use calcium and vitamin D supplements and who suffer from glucose 6 phosphate deficiency (G6PD) were excluded from the study.
The Phosphodiesterase 3 Inhibitor Cilostazol as an Adjunct to Conventional Therapy in Patients With Osteoarthritis

Cilostazol is able to suppress the degradation of type II collagen in human chondrocytes induced by IL-1b. Cilostazol add-on for celecoxib therapy has synergistic anti-arthritic potential by inhibiting proinflammatory cytokine production in synovial fibroblasts through the IL-10/SOCS3 pathways, consequently leading to the inhibition of synovial cell proliferation and overcoming the perpetuation of synovial inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Primary osteoarthritis Patients recruited were between 30 to 60 years of age, with X-ray confirmed Kellgren-Lawrence grade13 II or III severity primary tibiofemoral OA, according to the American College of Rheumatology criteria.

Exclusion Criteria:

* Those patients were excluded from the present study who:

  * were of age less than 30 years or more than 60 years
  * presented with active concomitant gastroduodenal disorders, hepatic and renal impairment within last 30 days prior to receiving the study drug
  * were diagnosed to have any inflammatory arthritis, gout or acute trauma of the knee, hip or spine; accompanying OA of the hip of sufficient severity to interfere with the functional assessment of the knee
  * had previous or ongoing treatment with oral SYSDOA (e.g., glucosamine sulphate, chondroitin sulphate, diacerein, piascledine), anti-depressants, tranquillisers, antacids or antibiotics; were having active cardiac lesion or hypertension, were pregnant females and those who were planning their pregnancy during the study
  * were having a known hypersensitivity to the used medications
  * have persistent diarrhoea or laxative use; severe gastrointestinal disorders, severe obesity, severe parenchymal organ disease, or anaemia (haemoglobin\< 10.0 g/ dl or haematocrit \< 30%).
  * Patients who received oral, intramuscular, intraarticular or soft tissue injections of corticosteroids within last eight weeks before receiving the first dose of the study medication, or had undergone joint lavage and arthroscopic procedures in the previous 6 months, were also excluded.
A Phase I Study of ONO-4538HSC in Subjects With Advanced or Metastatic Solid Tumors

This is a multicenter, open-label, uncontrolled, phase I study to evaluate the tolerability, safety, pharmacokinetics, and efficacy of ONO-4538HSC administered subcutaneously in participants with advanced or metastatic solid tumors. This study consists of the tolerability confirmation part to determine the recommended dose for Japanese participants by evaluating the DLTs and the expansion part to evaluate the safety and pharmacokinetics and to explore the efficacy.


Eligibility Criteria:
Inclusion Criteria:

1. Patient with advanced or metastatic solid tumors
2. Patients have an ECOG performance status of 0 to 1
3. Patients with a life expectancy of at least 3 months

   \[Tolerability confirmation part\]
4. Patients who are refractory or intolerant to standard therapy or for whom no standard therapy is available

   \[Expansion part\]
5. Patients who are refractory or intolerant to standard therapy, or for whom no standard therapy is available, or for whom monotherapy with intravenous nivolumab is indicated according to the package insert

Exclusion Criteria:

1. Patients with a complication or history of severe hypersensitivity to any antibody product
2. Patients with severe complication
Multi-omics Analyses Reveal Microbiota-gut-brain Axis in ICU Patients With Post-cardiac Surgery Delirium

This case-control study is planned to recruit patients who meet the enrollment conditions, receive cardiac surgery (cardiac valve surgery or coronary artery bypass surgery) and cardiopulmonary bypass, and sign the informed consent form in the second ward of adult cardiac surgery, Fuwai Hospital. Use RASS, CAM-ICU scales to evaluate postoperative patients and divide them into delirium and non-delirium groups according to whether they had delirium after surgery. There will be 30 patients in each group. Match the two groups in terms of surgical type, duration of cardiopulmonary bypass, gender and age range (± 3 years). Collect and record the preoperative, intraoperative and postoperative data of the enrolled patients, including cardiopulmonary bypass time, ICU stay time, length of mechanical ventilation, hemodynamics and other data. Fecal and/or blood samples are collected from 60 patients before, immediately after and after operation.

The laboratory test and analysis shall be started after the collection of clinical samples. Fecal samples are used for Metagenomics Sequencing and Functional genomics. Blood samples are analyzed by serum metabolomics for changes in intestinal metabolites entering the blood circulation. Simultaneous measurement of IL-6 and TNF in peripheral blood with serum samples- α, IL-1a,IFN-γ and LPS, D-lactic acid and diamine oxidase levels.Use Multi-omics approach to analyze the correlation between intestinal flora diversity, functional gene abundance and blood metabolites, inflammation level and intestinal barrier function, and to find the clinical evidence of the correlation between microbiota-gut-brain axis and the occurrence of POD in patients. Through comprehensive analysis of the research results of this experiment, access to literature, write papers, submit papers and publish relevant papers.


Eligibility Criteria:
Inclusion Criteria:

* elective cardiac valve surgery or coronary artery bypass grafting
* open heart surgery under hypothermic cardiopulmonary bypass under intravenous and/or inhalation general anesthesia
* No history of delirium attack, no cognitive impairment, normal speech, and certain ability of speaking and reading
* age\>18
* Informed consent of patients, voluntary participation (or consent of family members), and signing of informed consent

Exclusion Criteria:

* There are organic brain diseases (preoperative brain CT examination)
* Hearing or visual impairment that may affect delirium assessment
* Suspected or confirmed history of alcohol/drug/drug abuse
* Previous history of mental illness or preoperative use of antipsychotic drugs
* Moderate and severe renal function damage (blood creatinine \> 2mg/dL or 177mmol/L) or abnormal liver function (alanine aminotransferase\>2 times the upper limit of normal value) or other serious lung diseases
* Hematologic diseases, bone marrow and/or lymphoid diseases, leukopenia
* Use immunosuppressive drugs or autoimmune diseases
* Pregnant
* Accompanied by other diseases that may affect their survival, such as tumor
* HIV
Clinical Study of Capecitabine, Oxaliplatin and Bevacizumab in Colorectal Cancer

This study will evaluate the efficacy, safety and pharmacokinetics of capecitabine (2000 mg/m2/day by mouth \[po\], day 1 pm-day 15 am every 3 weeks \[q3w\]), oxaliplatin (130 mg/m2 intravenously \[iv\], day 1 q3w) and bevacizumab (7.5 mg/kg iv, day 1 q3w) in patients with advanced and/or metastatic colorectal cancer.

This study will evaluate the efficacy, safety and pharmacokinetics of Capecitabine (2000 mg/m2/day po, day 1 pm-day 15 am q3w), Oxaliplatin (130 mg/m2 iv, day 1 q3w) and Bevacizumab (7.5 mg/kg iv, day 1 q3w) in patients with advanced and/or metastatic colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients 20-74 years of age
* Histologically confirmed colorectal cancer
* Metastatic and/or locally advanced colorectal cancer not previously treated with chemotherapy for metastatic disease
* At least one measurable lesion according to RECIST

Exclusion Criteria:

* Evidence of clinically detectable ascites at study treatment start
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study; fine needle aspiration within 7 days prior to study treatment start.
* Evidence of bleeding diathesis or coagulopathy
* Serious, non-healing wound, ulcer, or bone fracture
* Chronic, daily aspirin (\> 325 mg/day), anticoagulants, or other medications known to predispose to gastrointestinal ulceration
IPC Status as a Surgical Quality Marker in Rectal Cancer Surgery

Risk of local recurrence after rectal surgery is nationally 8% after curative surgery to 5%. Local recurrence rate after curative surgery varies between 3-7% in the variety of regions in the country. It is well known that the surgical technique total mesorectal excision (TME) has led to improved prognosis after rectal cancer surgery. TME surgery is difficult to perform and different factors affect the quality of TME preparations. Injuries in mesorectal fascia has been reported in up to 20% of patients who underwent TME surgery and most surgeons agree that this may be important for recurrences. However, it is unclear to what extent a damaged mesorectal fascia can be related to a worsening of prognosis in patients with rectal cancer.

Adjuvant oncological treatment in form of chemotherapy after surgery, is offers patients with unfavorable tumors based on the pathological examination. Patients with favorable tumors (less advanced) are not offered chemotherapy, even if the surgical technique was not optimal, ie. that there is damage in the mesorectal fascia, as evidence for this is lacking.

The presence of intraperitoneal cancer cells (IPC) is related to histopathological tumor stage of colorectal cancer. Incidence of IPC of intraperitoneal tumors (rectal cancer patients with tumors below the peritoneal reflection) is unclear.

Assessment of IPC status with cytology and immunohistochemistry is technically easy and could after TME surgery identify those patients who have an increased risk of tumor recurrence. In a positive IPC status, the patient would possibly benefit from either postoperative radiotherapy if the patient did not receive preoperative therapy, or postoperative oncological chemotherapy.

Tumour cells may be lysed in sterile water, and some surgeons rinse the abdominal cavity and the bowel distally to the tumour. Neither rinsing the abdomen or rectum in colorectal cancer is routinely occurring and the clinical benefit has not been established. The value of rinsing the abdomen after TME-surgery could also be studied by IPC status.

The study hypothesis is that the IPC status is dependent on the surgical quality of the specimen after TME-surgery in rectal cancer patients, and its presence leads to increased risk of local recurrence.


Eligibility Criteria:
Inclusion Criteria:

* rectal cancer patients that are going to be operated with bowel resection
* control patients (10 patients) - patients with different conditions that are going to be operated.

Exclusion Criteria:

* none
Role of Huachansu in Treating Hepatocellular Carcinoma and the Correlation With Na+/K+-ATPase

Primary Outcome Measures:

- To compare the progression free survival(PFS) in patients with unresectable hepatocellular carcinoma(HCC) treated with transcatheter arterial chemoembolization(TACE) with or without Huachansu, and the correlation between PFS and expression of peripheral Na+/K+-ATPase α3 family.

Secondary Outcome Measures:

- To compare the overall survival(OS), objective response rate(ORR), and side effects of treating HCC with TACE plus Huachansu or TACE alone.

Exploratory Outcome Measures:

- To evaluate the correlation between prognosis and expression of peripheral Na+/K+-ATPase α3 family.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects 18-75 years of age.
* Diagnosis of hepatocellular carcinoma. Biopsy is the preferred method of diagnosis (option 1). As far as clinically possible, the results of a biopsy should be obtained to confirm the diagnosis prior to the initiation of investigational product administration.. Non-biopsy criteria are allowed in cases where a biopsy result is unavailable and a biopsy procedure is not clinically indicated (option 2). (Option 1: Biopsy-proven HCC (histology or cytology); Option 2 - patient must fulfill the following criteria: i. Radiological evidence of HCC showing lesion arterial hypervascularity and venous phase washout by either dynamic (triple-phase), contrast-enhanced computed tomography of the abdomen OR dynamic (triple-phase) contrast (gadolinium)-enhanced MRI, AND ii. Serology positive for hepatitis B or C, AND iii. Alpha fetoprotein \> 400 μg/L at the time of diagnosis.)
* No metastasis outside liver.
* Unable or unwilling to receive radical surgery.
* No prior transcatheter arterial chemoembolization.
* No prior treatment of bufalins including Huachansu.
* At least one measurable untreated lesion. All subjects must have at least one measurable lesion unidimensionally by CT or MRI scan, according to modified RECIST for HCC, that has not been previously treated with surgery, irradiation, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
* Cirrhotic status of Child-Pugh Class A or B.
* Adequate hematologic function with absolute neutrophil counts ≥ 1.5×109 /L, platelet count ≥ 50 x 109/L, and hemoglobin ≥ 85 g/L.
* Signed Written Informed Consent.
* Subjects who have a life expectancy of at least 3 months.
* Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study that the risk of pregnancy is minimized.

Exclusion Criteria:

* Previously treated target lesion with irradiation, TACE, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
* Cirrhotic status of Child-Pugh Class C.
* Severe diseases of heart, liver, kidney, etc that may cause inadequate organ functions
* History of other malignant tumor in 5 years.
* Pregnant or lactating women.
* Mentally disordered.
* Participation of other clinical trials within a month.
Virtual Reality in Postoperative Acute Pain Management in Thoracic Surgery

This randomized controlled study is to investigate the effectiveness of VR headsets in reducing postoperative pain intensity among patients after having undergone thoracic surgical procedures.

Thoracic surgical procedures can often result in postoperative pain. Traditional methods of pain management, such as medication, have limitations in terms of their efficacy and potential side effects. Therefore, there is a need for alternative approaches that can effectively alleviate postoperative pain while minimizing medication use. Virtual reality (VR) technology has gained attention as a potential non-pharmacological intervention for pain management. There is limited research specifically focusing on the use of VR in the context of thoracic surgery. This study is to investigate the effectiveness of VR headsets in reducing postoperative pain intensity among patients after having undergone thoracic surgical procedures. To enhance the objectivity of the investigation, objective parameters alongside subjective assessments of pain will be incorporated. While self-reported measures are valuable, they can be subjective and influenced by individual perception. Therefore, the subjective assessments will be complemented by objective measurements to gain a more comprehensive understanding of the pain experience and its modulation through the VR intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years
* Written informed consent as documented by signature from the patient
* Video-assisted anatomical resection of the lung (VATS) (Surgery duration of at least 90 minutes)
* Ability to speak, understand and read German

Exclusion Criteria:

* Significant mental, cognitive or neurological impairments (Delirium, psychoses, unstable dissociative disorders, any form of organic brain disorder, ...)
* Inability to follow the study procedures (e.g., due to language problems, visual and hearing impairments)
* Chronic pain
* Morphine intolerance
* Excessive alcohol consumption (men \> 3 standard drinks, women \> 2 standard drinks per day)
* Substance abuse
* Unable or not willing to sign informed consent
An Extension Study of ABT-806 in Subjects With Advanced Solid Tumors

This is an extension study of ABT-806 for subjects with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Subject has completed a prior study utilizing ABT-806 or 111ln ABT-806 (ABT 806i) and the Investigator believes that continued treatment with ABT-806 is in the best interest of the subject.
* Women of childbearing potential and men must agree to use adequate contraception (one of the following listed below) prior to study entry, for the duration of study participation and for a period of 3 months. Female subjects considered not of childbearing potential must be documented as being surgically sterile or post-menopausal for at least 1 year.
* Subject is capable of understanding and complying with parameters as outlined in the protocol and the subject or the subject's legal acceptable representative is able to sign informed consent, approved by an Institutional Review Board (IRB) prior to the initiation of any or study-specific procedures.

Exclusion Criteria:

* Subject discontinued ABT-806 or111ln ABT-806 (ABT-806i) administration before completing the prior study (due to disease progression, toxicity, withdrawn consent, other).
* Subject has any medical condition which in the opinion of the investigator places the subject at an unacceptably high risk for toxicities.
* Subject is a lactating or pregnant female.
Continuous Renal Replacement Therapy With Oxiris in Acute Kidney Injury and Sepsis

It is an epidemiology study to explore outcomes in patients with acute kidney injury (AKI) and sepsis submitted to continuous renal replacement therapy (CRRT) with Oxiris™.

Objectives:

Describe the experience and outcomes in patients with sepsis and AKI treated receiving CRRT with the adsorption membrane filter Oxiris™

Study Background \& Rationale:

Acute kidney injury (AKI) is common in patients with sepsis, occurring in 5-50%. It happens in the context of a critical illness requiring intensive care. Fifteen percent require renal replacement therapy as supportive therapy until the kidneys recover. Membrane-coated filters, such as Oxiris™, promote high filtration clearance of uremic toxins, but additionally removal of inflammatory mediators and bacterial liposaccharide (LPS) . Even though this potential mechanism should be expected to benefit septic and AKI patients, results have not been uniform.

The investigators´ group has been prescribing CRRT for AKI treatment for the last 20 years, having performed more than 20 thousand procedures. The investigators´ group experience with Oxiris™ filter in CRRT started in 2018. The objective of the study is to describe the clinical operational management of CRRT with this kind of filter and to explore patients' outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Adults (\>18 years)
* Diagnosis of AKI (KDIGO stage 3)
* Diagnosis of sepsis of any cause

Exclusion Criteria:

* COVID19 diagnosis