cyrilzakka/clinical-trials huggingface dataset:
Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers

To find out if combining psychoeducational interventions (such as education, counseling, and self-managed therapies) with an open-label placebo can help to improve your quality of life better than either the psychoeducational interventions or the placebo alone.

Primary Objectives:

1. To determine if the combination therapy of PI with OLP (combination therapy group) is superior to PI alone group in the treatment of cancer-related fatigue (CRF) as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale.

We hypothesize that the combination of OLP+PI in these patients will result in a greater reduction of CRF compared to PI alone.

Secondary Objectives:

1. To determine if Combination Therapy group is superior to PI Only group for the treatment of CRF at 3 months and 6 months after treatment. We hypothesize that the combination of OLP+PI in these patients will result in a greater reduction of CRF after 3 months and 6 months after treatment

3. To determine the effects of combination therapy on fatigue-related quality-of-life, mood, sleep-wake activity, cognitive measures, and inflammation. We will assess measures including quality of life (Functional Assessment of Cancer Therapy - General, FACT- G), multidimensional fatigue (Multidimensional Fatigue Symptom Inventory, MFSI-SF), sleep disturbance (PROMIS-sleep), anxiety (Hospital Anxiety and Depression Scale - HADS), depressed mood (HADS), cognitive function (Symbol digit modality test, SDMT), sleep/wake time activity (actigraphy), and inflammation (C-reactive protein levels).

We hypothesize that combination therapy will result in improvements in CRF-related quality of life, mood, sleep-wake activity, and cognitive measures.

Eligibility Criteria:
Inclusion Criteria:

1. Be advanced cancer patients (incurable metastatic), having fatigue with severity of 4/10, on a 0-10 scale (Edmonton Symptom Assessment Scale) for at least 2 weeks.
2. Have no clinical evidence of cognitive failure as evidenced by treating clinician assessment at screening (Memorial Delirium Assessment Scale of less than 13/30).
3. Be aged 18 years or older.
4. Be willing to complete in-person or with research staff, and able to complete Psychoeducational intervention either in person or virtually within Texas.
5. Have a hemoglobin level of ≥10 g/dL within 2 weeks of enrollment.
6. Be able to understand the description of the study and sign a written informed consent.
7. Have a ECOG performance status score of 0 to 2; and
8. Be seen at an outpatient clinic at MD Anderson Cancer Center's (MDA) main campus or its Houston Area Locations (HALs)

Exclusion Criteria:

1. Have a major contraindication to placebo (e.g., allergy or hypersensitivity to study medications or their constituents), or conditions making adherence difficult as determined by the attending physician.
2. Be unable to complete the baseline assessment forms or to understand the recommendations for participation in the study.
3. Be pregnant or become pregnant while on study.
Gastric Ultrasound Assessment for Patients Taking GLP1 Agonists

The aim of this study is to perform bedside gastric point of care ultrasound (POCUS) exams to assess the gastric volume and content (clear liquids vs solid food) perioperatively in patients who take glucagon-like peptide 1 (GLP-1) agonist medications compared to patients who do not take GLP-1 agonists.

Glucagon-like peptide 1 (GLP-1) agonists have existed since 2005, however the newer once-weekly injectable medications particularly semaglutide, and tirzepatide have exploded in popularity due to their weight loss potential.

Anesthesiologists nationally have seen an increase in perioperative complications amongst patients taking these medications due to delayed gastric emptying increasing the risk of aspiration in the perioperative period. At HSS the majority of our anesthetics are done under sedation and therefore would not protect the patient from aspiration in the event of vomiting.

Protecting patients from aspiration secondary to vomiting during induction or maintenance of anesthesia has always been an important goal to make anesthesia safer leading to the development of NPO guidelines which are intended to protect against the presence of gastric content during anesthetic care. However there is growing concern that patients taking GLP-1 agonists may not be adequately protected using the current nothing by mouth or "NPO" guidelines. Up to this day there is no literature on how much gastric emptying is delayed during the use of GLP1 following the standard NPO guidelines.

Recently Gastric Ultrasound (GUS) has been introduced as a bedside tool for assessing a patients stomach contents and for the risk of aspiration. Gastric ultrasound can identify an empty stomach, a stomach filled with clear liquids, thick liquids or solid food content. If a stomach has clear liquid the volume can be calculated accurately. Generally a stomach with solid or thick liquid content or with clear liquid measuring more than 1.5 ml/kg body weight is considered a full stomach. As GUS is noninvasive and well tolerated, it offers the perfect solution to assessing patient risk in the preoperative period.

Eligibility Criteria:
Inclusion Criteria:

* GLP 1 patient group: any patient on GLP1 agonists that are dosed once per week (semaglutide, dulaglutide, tirzepatide), for all indications.
* Control group (No GLP 1 patients): any patient not on GLP1 agonists that are dosed once per week, for all indications.

Exclusion Criteria:

* patient refusal to participate
* patients with gastric bypass or any other gastric surgery
* large hiatal hernia
* patients with large ascites
* patients on peritoneal dialysis
* emergency surgery
* pre-existing diagnosis of gastroparesis
A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features

This is a Phase III, randomised, open-label, multicentre, global study assessing the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig compared with SoC, after complete surgical resection (R0) in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive, as determined by the Sponsor-designated ctDNA assay, or have at least one high-risk pathological feature.

The primary objective of the study is to assess the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig relative to SoC, after complete surgical resection (R0) in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive, as determined by the Sponsor-designated ctDNA assay, or have at least one high-risk pathological feature.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically documented treatment-naive Stage I (T \< 4 cm, AJCC 8th ed) adenocarcinoma NSCLC
2. Complete surgical resection (R0) of the primary NSCLC
3. Unequivocal no evidence of disease at post-surgical
4. Pre-surgical ctDNA-positive result (Stage IA or IB) OR presence of at least one high-risk pathological feature (visceral pleural invasion (VPI), lymphovascular invasion (LVI), high-grade histology) (Stage IB only)
5. ECOG of 0 or 1, life expectancy of \> 6 months and complete recovery after surgery
6. Adequate bone marrow reserve and organ function

Exclusion Criteria:

1. Sensitizing EGFR mutation and/or ALK alteration
2. History of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
3. Significant pulmonary function compromise
4. History of another primary malignancy within 3 years (with exceptions)
5. Any evidence of severe or uncontrolled systemic diseases, including but not limited to bleeding diseases, active infection and cardiac disease
6. Active or prior documented autoimmune or inflammatory disorders (with exceptions)
7. Active infection with tuberculosis, hepatitis B or C virus, hepatitis A, or known HIV infection that is not well controlled
8. History of active primary immunodeficiency
9. Clinically significant corneal disease
Cognitive and Mood Effects of Docosahexaenoic Acid (DHA)-Rich and Eicosapentaenoic Acid (EPA)-Rich Fish Oil in Healthy Young Adults

To date, only a small handful of studies have assessed the effects of omega-3 polyunsaturated fatty acids (n-3 PUFAs) on cognitive function in healthy adults. The results from these studies are mixed, and have differed greatly in terms of methodology as regards sample size, treatment formulation and duration of the intervention. In order to address these issues, the present study aims to assess the effects of two different formulations of fish oil in parallel, and at doses consistent with the current recommended daily intake of oily fish, across a range of cognitive domains. The aim of the present investigation is therefore to specifically evaluate the effects of 12 weeks supplementation of DHA-rich fish oil and EPA-rich fish oil dietary supplements on cognitive function in healthy young adults maintaining a regular diet containing oily fish not more than once a week. Self-report mood assessments will form the secondary part of this investigation.


Eligibility Criteria:
Inclusion Criteria:

* Male/Female
* 18-35 years
* Healthy
* No herbal supplements/prescription medications (excl. contraceptive pill)
* Non smoker
* Native English speaker

Exclusion Criteria:

* Consumes ≥ 1 portion oily fish/week
* takes omega-3 supplement
* Food allergies to treatment ingredients
A Pilot Study to Assess the Amnesic Properties of Propofol in Pediatric Patients

The goal of this study is to extend findings of propofol's effects on memory, as measured in volunteer research studies, to a clinical setting.


Eligibility Criteria:
Inclusion Criteria:

* The patient must be between 4 and 14 yrs of age and be undergoing a therapeutic or diagnostic procedure with or without sedation
* The patient must be able to comprehend and perform the task (naming pictures)
* The patient must have a minimum weight of 8 kg

Exclusion Criteria:

* Allergy to propofol (for those patients requiring sedation)
* Procedure of short duration (\< 15 min)
* Pregnancy
* Recent use (within 5 half-lives) of centrally acting medications that could affect concentration (e.g. diphenhydramine)
Efficacy of the Integration of Digital Therapeutics and Home-based Cardiac Rehabilitation in High-Risk Post-PCI Patients

The DTx-HBCR trial will randomize 366 high-risk patients who undergo PCI at the West China Hospital of Sichuan University to either the 6-month DTx-guided HBCR group (intervention group) or the 6-months usual care group (control group) in a parallel-arm randomized controlled trial. The primary outcome is the difference between the intervention group and control group in walk distance on the 6-minute walk test (i.e., functional capacity) at 6 months post randomization. The key secondary outcomes include improvements in cardiovascular risk factor control, quality of life, psychological status, physical activity, major adverse cardiovascular events, and medication adherence. This study aims to evaluate the DTx-guided HBCR, a software-driven, multidisciplinary health intervention as an alternative to traditional in-center CR in patients with high-risk patients following percutaneous coronary intervention (PCI) compared with usual care alone.


Eligibility Criteria:
Inclusion Criteria:

* To be eligible to participate in this study, a participant must meet all of the following criteria:

  1. Women or men, the ages of 18 and 75 years.
  2. Have sufficient reading and writing language skills in Chinese.
  3. Be willing to participate the study and sign informed consent.
  4. Patients must have at least one clinical feature and one angiographic feature:

A. Clinical features: age ≥ 65 years, female sex, troponin positive acute coronary syndrome, established vascular disease (prior myocardial infarction, coronary revascularization or peripheral arterial disease) , diabetes mellitus requiring medication and chronic kidney disease (estimated glomerular filtration rate \< 60 ml/min/1.73 m2 or creatinine clearance \< 60 cc/min) .

B. Angiographic features: multivessel coronary artery disease, total stent length \> 30 mm, thrombotic target lesion, bifurcation lesion requiring two stents, obstructive left main or proximal left anterior descending lesion and calcified target lesion requiring atherectomy.

Exclusion Criteria:

* A potential participant who meets any of the following criteria will be excluded from participation in this study:

  1. Contraindications to exercise rehabilitation (e.g., untreated ventricular tachycardia, severe heart failure (New York Heart Association class III or IV heart failure, or ejection fraction \< 40%), uncontrolled hypertension or hypotension, active hemorrhage, severe liver failure, significant exercise limitations).
  2. Vision, hearing, cognition-related or mental impairment leading to inability to cooperate.
  3. Patients with established planned Phase II PCI.
  4. Having pre-existing comorbid disease with a life expectancy of \< 1 year.
  5. Poor compliance and unable to complete the expected follow-up.
  6. Unable to access WeChat via a smartphone after training.
A Multicentre Trial to Compare Two Articulating Bearing Surfaces as Used in Cementless Primary Hip Arthroplasty

The aim of this study is to demonstrate the non-inferiority of the ceramic-on-metal articulation using large diameter bearings (38mm to 60mm) compared to the metal on metal articulation using the same cup in regards to the composite clinical success (CCS) rate at 2 years postoperatively (delta = 10% minimum clinically significant difference in rates).

This multicentre randomised controlled trial will compare the clinical outcome of the ceramic-on-metal articulation against a metal-on-metal articulation using the same Recap Acetabular cup.

The metal ion release will be evaluated at predetermined postoperative intervals during the first 36 months. A trial will be conducted as a clinical trial in accordance with the Medical Devices Directive 93/42/EEC (2002).

A total of 150 patients have to be recruited from the South African centre (2 groups)

The initial study assessment period will be 48 months; 24 months recruitment and 24 months follow-up. The follow-up reviews will be at 6 weeks, 6 months, 1 year, 2 years and 3 years. A 5 year and 10 year clinical review will also be carried out with all patients.

An assessment of incidences of adverse events and metal ion release concentrations will be made when all patients are at 6 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Primary total hip replacement
* Patient with degenerative joint disease (inflammatory or non-inflammatory) or any of the composite diagnoses of osteoarthritis,avascular necrosis, legg perthes, rheumatoid arthritis, diastrophic variant, fracture of the pelvis, fused hip, slipped capital epiphysis, subcapital fractures, traumatic arthritis
* Patients preoperative Harris hip score \< 80 points
* Patients with limited co-morbidity - ASA I - III
* Patients with normal urea and electrolyte levels and creatinine levels
* Patients must be able to understand instructions and be willing to return for follow-up
* Patients willing to provide blood and urine samples for metal ion analysis at follow-up

Exclusion Criteria:

* Patient preoperative Harris hip score \> 80 points
* Pre-existing metal implants
* Patients with significant co-morbidity - ASSA IV - V
* Dementia and inability to understand and follow instructions
* Neurological conditions affecting movement
* Women younger than 45 years old
* Presence of symptomatic arthritis in other lower limb joints
* Patients requiring smaller than 38mm and larger than 60mm diameter femoral heads
* Patients taking NSAIDs and / all drugs that will affect bone metabolism
A Trial of HRS-6768 in Patients With Advanced Solid Tumors

The study is being conducted to evaluate the pharmacokinetics, radiation dosimetry, safety and preliminary efficacy of HRS-6768. To explore the reasonable dosage of HRS-6768 in the treatment of patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. subjects with solid tumors who have been histologically or cytologically diagnosed with advanced - stage (unresectable or metastatic) disease, have failed standard treatment (disease progression or intolerance), or lack effective treatment methods.
3. There must be at least one measurable lesion as the target lesion (according to the RECIST V1.1 criteria).
4. ECOG 0-1
5. The functions of major organs are in good condition.

Exclusion Criteria:

1. The patient has experienced significant weight loss within 28 days prior to signing the informed consent form.
2. The patient has previously received radiopharmaceutical therapy or radioactive embolization, or has previously undergone any external beam radiotherapy (EBRT) involving more than 25% of the bone marrow, or has previously had EBRT directly applied to the kidneys, or has received any EBRT within 2 weeks before the first dose.
3. The patient has received anti - tumor treatments such as surgery (excluding diagnostic biopsy and serous cavity effusion drainage), checkpoint inhibitor therapy, other antibody therapies, chemotherapy, targeted therapy, gene therapy, and vaccine therapy within 4 weeks before the first dose.
4. The patient has had a severe infection (CTCAE \> Grade 2) within 4 weeks before the first dose, such as severe pneumonia requiring hospitalization, bacteremia, and infectious complications. The patient has had symptoms and signs of infection within 2 weeks before the first dose that require intravenous antibiotic treatment (excluding cases of prophylactic antibiotic use).
Efficacy and Tolerability of Combination Antihypertensive Drug in Non-Responders to ARB monoTHerapy Using 24h ABPM

A majority of Korean doctors tend to add other antihypertensive rather than to titrate the same drug.

However, we try to induce doctors to titrate the Sevikar than to add other antihypertensive if patients are not controlled with Sevikar 5/20mg(amlodipine 5mg + omlesartan 20mg). As above, for patients who are not controlled with Sevikar 5/20mg, doctors will proceed to other prescription pattern with other choices of titration to Sevikar 5/40, 10/40mg.

It is important to evaluate BP lowering efficacy of Sevikar through the titration step in patients uncontrolled with Sevikar low dose. Thus, this study is designed to demonstrate the efficacy of Sevikar by titration in patients who are not controlled their BP with low dose of Sevikar.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects \> 55 years
2. Subject who has consent to participate by signing on the informed consent form
3. Uncontrolled hypertensive patients defined as:

   * Uncontrolled hypertensive: subjects who are mean SBP ≥ 140 mmHg after being treated with ARB(Valsartan 80mg or Candesartan 8mg) monotherapy during at least 4 weeks.

Exclusion Criteria:

1. Secondary hypertension
2. SeSBP ≥ 180mmHg
3. SeSBP difference ≥ 20mmHg or SeDBP difference ≥ 10mmHg
4. A history of hypertensive encephalopathy, unstable angina, transient ischemic attack, MI, or any type of revascularization procedure within the last 6 months
5. Heart failure, second- or third-degree heart block, significant arrhythmia or valvular heart disease
6. Significant cardiovascular, cerebrovascular, renal, gastrointestinal, or hematologic disease, at the discretion of investigator
7. Creatinine clearance\<20mL/min and Renal artery stenosis, Renal Transplantation, Patients with only one kidney
8. Evidence of liver disease as indicated by alanine transaminase (ALT) and aspartate transaminase (AST) and/or total bilirubin ≥ 3 × the upper limit of normal (ULN)
9. Hyperkalemia (\>5.5mmol/L)
10. Patients with sodium depletion is not correct or Patients with fluid depletion is not correct
11. Chronic inflammation
12. Patients with severe eye-related disorders (Retinal bleeding within 6 months, Blindness, Hypertension complications with Retinal micro-aneurysms)
13. Diabetes mellitus
14. Hematologic/oncologic, neurologic and psychiatric diseases
15. Females who were pregnant, breastfeeding, planning a pregnancy or who were of childbearing potential
16. Contraindications for amlodipine, losartan, olmesartan medoxomil, or other ARBs
17. With known allergic reaction, lack of response or contraindication to Angiotensin II receptor antagonists
18. Mean DBP \> 110 mmHg
19. Patients who took antihyperlipidemic agents within 30 days
20. Subject who have participated in other clinical trial within the last one month
21. Any subjects who are unable to cooperate with protocol requirements and follow-up procedures or who are in medical condition that is not eligible to be entered in investigators' discretion
A Study on Transcutaneous Vagus Nerve Stimulation in Perioperative Period of Percutaneous Coronary Intervention

The goal of this clinical trial is to study the effect of transcutaneous auricular vagus nerve stimulation on perioperative blood pressure.

The main question it aims to answer is:

•Wether the transcutaneous auricular vagus nerve stimulation have advantages in perioperative blood pressure elevation.

Participants will sign an informed consent form, collaborate with data collection, and are randomly divided into two groups(1:1) to accept the intervention measures from corresponding groups. Researchers will record the perioperative blood pressure and compare intervention group with sham group to see if there is any difference in perioperative blood pressure.

Sharp variations in blood pressure are more common in patients with hypertension. In non-cardiac procedures, up to 25% of patients will experience perioperative hypertension, which raises the risk of bleeding, cerebrovascular accidents, and cardiovascular events. Significant contributing factors include excessive sympathetic nerve activation, intraoperative and postoperative discomfort, and patient anxiety prior to surgery. The primary cause of perioperative hypertension is the malfunction of arterial dilatation and contraction brought on by renin-angiotensin system activation, which offers fresh approaches to perioperative blood pressure management.

Numerous research conducted in recent years have demonstrated that auricular stimulation of the vagus nerve can also have a number of effects on different parts of the brain, resulting in the regulation of the autonomic nerve balance in the heart. In healthy people, transcutaneous vagus nerve stimulation can lower cardiovascular sympathetic nerve excitability and control the sensitivity of baroreceptor reflexes, both of which are crucial for blood pressure regulation.

Eligibility Criteria:
Inclusion Criteria:

* Ages between 18 and 70 years old, regardless of gender
* Patients with indications for coronary artery stent implantation
* hypertension history
* Voluntarily participate and sign an informed consent form

Exclusion Criteria:

* Patients with acute myocardial infarction
* Patients with heart failure of NYHA class III - IV
* Patients with atrial fibrillation (indicated by definite medical history or electrocardiogram on admission)
* Patients with a medical history of hyperthyroidism
* Patients with subclavian artery occlusion (indicated by definite medical history or a difference in systolic blood pressure of more than 20 mmHg between the two upper limbs)
* With an estimated glomerular filtration rate (eGFR) of less than 60 ml/min/1.73m² on admission
* Patients with infections and fever
* Patients who are unable to cooperate due to mental and psychological disorders (such as mania, depression)
* Patients with tinnitus and vertigo
* Pregnant women or patients who are attempting to get pregnant
* Patients participating in clinical trials of other drugs or medical devices
* Patients deemed unsuitable by the researchers to participate in this clinical trial