cyrilzakka/clinical-trials huggingface dataset:
By Using Adoptive Transfer of Autologous NK Cells to Prevent Recurrence of Hepatocellular Carcinoma After Curative Therapy

To prove that the efficacy and safety of 'NK group' is superior to 'non-treatment group(Control group)' in patient undergone curative resection(RFA or operation) for hepatocellular carcinoma in China.

No adjuvant therapy has been shown to extend the survival of patients with hepatocellular carcinoma receiving curative treatment.We investigated whether injections of NK cells prolongs recurrence-free survival of patients after curative therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Prior to the test, patient is fully explained about the purpose/ contents and characteristics of the testing medication, and the patient him(her)self, the guardian or the legal representative signed on written consent.
2. Gender unlimited, age from 18 years to 70 years
3. The patient is diagnosed as hepatocellular carcinoma by pathological/ radiological test and he (she) is in the stage of I or II. (refer to the attached file 10). Hepatocellular carcinoma should be shown by radiological test; on dynamic CT, dynamic MRI or on angiography.
4. Child-Pugh Score should be less than 6
5. No matter how the patient has been treated before, his (her) tumor should be totally removed by curative resection (RFA or operation). (based on the agreement date for written consent)
6. Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of \>94%, and adequate renal function(Cr≤133umol/L).
7. Patient's remaining life-time should be expected at least more than 3 months.

Exclusion Criteria:

1. Hepatocellular carcinoma has been transferred by pathological/ radiological test (Stage III or Stage IV, refer to the exhibit 10)
2. The carcinoma has been invaded to main portal vein or major branch hepatic vein
3. Child-Pugh score is over 6
4. Patient has serious problem with pulmonary function by sub- investigator's opinion
5. Patient who has disease history of immune deficiency
6. Diagnosed as an immune deficiency patient
7. Patient who has disease history of malignant tumor within 5 years before this clinical trial.
8. Patient who had anti-cancer medication before the clinical trial
9. Patient has serious allergic-history by sub- investigator's opinion
10. Patient has serious mental disease by sub- investigator's opinion
11. Pregnant women, nursing mother or having intention of being pregnant during the clinical test
12. Patient who participated in other clinical trial within 4 weeks before this clinical trial
13. Patient who is incongruent to this clinical trial by sub- investigator's opinion.
Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2609 in Healthy Subjects and an Elderly Cohort

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of E2609 when administered as single doses to healthy adult volunteers and healthy elderly subjects. The study will consist of 2 parts:(1) a single dose in healthy adult volunteers, at doses up to 800 mg or the maximum dose that can be tolerated, (2) a single dose of 50 mg in healthy elderly volunteers.

The study will consist of 2 parts: (1) a single dose in healthy adult volunteers, at doses up to 100 mg or the maximum dose that can be tolerated, (2) a single dose of 25 mg or lower in healthy elderly volunteers.

Eligibility Criteria:
Inclusion:

* Healthy males and females
* Aged 30 to 55 years, inclusive (Cohorts 1 through 5); aged 65 to 85 years, inclusive (Cohort 6)
* Body mass index (BMI) of 18 to 32kg/m\^2 at Screening
* Additional inclusion criteria for Cohort 6 (healthy elderly subjects)

Exclusion

* Females of child-bearing potential
* Personal or family history of neurological abnormalities
* Any clinical abnormality of the electrocardiogram (ECG)at Screening and check-in
* A family history of cardiac abnormalities
* Thyroid abnormalities
A Study of Alvimopan for the Management of Postoperative Ileus in Participants Undergoing Radical Cystectomy

This study is being conducted to determine whether alvimopan can accelerate recovery of gastrointestinal function following radical cystectomy when compared with a placebo. Secondary objectives of the study are:

* to evaluate the effect of alvimopan on hospital length of stay
* to evaluate the effect of alvimopan on prespecified postoperative ileus (POI)-related morbidities
* to evaluate the overall and cardiovascular safety of alvimopan


Eligibility Criteria:
Inclusion Criteria:

* are either Male or Female at least 18 years of age
* are scheduled for radical cystectomy
* are scheduled to receive postoperative pain management with intravenous participant-controlled opioid analgesics

Exclusion Criteria:

* are scheduled for a partial cystectomy
* have taken more than 3 doses of opioids (oral or parenteral) within 7 days before the day of surgery
A Tele-exercise Program for Breast Cancer Survivors

The research protocol outlines a pilot study for a home-based and group-based tele-exercise program designed for breast cancer survivors. The study is a randomized controlled trial (RCT) led by Dr. Yang Gao from Hong Kong Baptist University, with multiple other investigators from Kwong Wah Hospital and the university itself.

Breast cancer is identified as the most prevalent cancer among women globally and in Hong Kong. The document states that adjuvant therapies post-surgery, such as radiation and chemotherapy, can have both short-term and long-term side effects, which may affect the survivors' physical and mental health.

The study is based on evidence that physical activity levels often decrease after a breast cancer diagnosis and that exercise can mitigate the side effects of treatment, improving health and quality of life. The pilot aims to test the acceptability and feasibility of a 12-week tele-exercise program that combines psychological theories and behaviour change techniques, transitioning from supervised to unsupervised exercise to build sustainable exercise habits.

The study will enrol 24 patients, randomly assigning them to an intervention group or an active control group. The intervention group will receive 12 online training sessions plus 4 psychological counselling sessions, whereas the control group will receive educational essays on exercise and health.

The training sessions for the intervention group will include various exercises with increasing intensity and duration over the 4 weeks, monitored by a pulse oximeter to ensure exercises are done at the appropriate heart rate. The sessions will be led by qualified coaches, with Dr. Gao overseeing quality control.

It is a prospective and pilot study of RCT. It will be a pilot to test the acceptability and feasibility of a two-armed tele-exercise RCT to mitigate symptoms and improve health for breast cancer survivors. In this study, outcome assessors and data analysts will be masked from the allocation results. The pilot will recruit 24 patients and randomly assign them to an intervention group (Group A) and an active control group (Group B). All participants in both groups will continue receiving usual care from the study hospital during the study period. Additionally, those in Group A (intervention) will receive the tele-exercise (12 home-based online training sessions + 4 psychological counselling sessions), while those in Group B (active control) will receive 4 essays on exercise and health. Outcome measurements will be repeatedly performed before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Females aged 40-64 years old;
* Within 6 weeks after completion of chemotherapy;
* Without severe anemia;
* Without cancer metastasis;
* Able to read and communicate in Cantonese or Mandarin;
* Smartphone users.

Exclusion Criteria:

* With any medical, physical and psychological conditions that may limit participation (e.g., uncontrolled severe cardiovascular disease, schizophrenia, severe neurological dysfunction, etc.).
Mucosal Immunity: Influence on Infectious Viral Load: a Prospective Observational Study

The goal of this observational study is to learn about the influence of pre-existing mucosal immunity, i.e. antibodies and immune cells that are present at the nasal mucosa before infection, on the infectious viral load after infection with SARS-CoV-2, influenza virus and RSV. The investigators will include app. 320 participants which will be followed for up to 17 months. During this time, the investigators will monitor their nasal mucosal antibodies at regular intervals and compare them to their infectious viral load if they are infected with SARS-CoV-2, influenza virus or RSV. Participants are invited to take a test for SARS-CoV-2, influenza virus or RSV in case of respiratory symptoms. If participants are positive the investigators will follow their viral load kinetics by taking nasopharyngeal swabs every 2-3 days. The investigators will also record the duration and strength of the following symptoms:

* Cough
* Fever
* Tired
* Sore throat
* Difficulty breathing
* Respiratory distress
* Headache
* Loss (or alteration) of smell
* Loss (or alteration) of sense of taste
* Myalgias
* Chills
* Subjective fever
* Pink sputum (or coughing up blood)
* Thoracic pain
* Runny nose
* Abdominal pain
* Nausea
* Vomiting
* Diarrhea
* Constipation
* Irritated or watery eyes
* Rashes
* Other


Eligibility Criteria:
Inclusion Criteria:

* In general good health, as determined by study investigators
* All participants must be living in the canton of Geneva or working/studying in the canton of Geneva and living in neighboring communities that are within one hour travelling distance by car.

Exclusion Criteria:

* Inability to provide written consent.
* Severely immunocompromised subjects as determined by the study investigator
* Treated with inhaled drugs by nasal route within the last month
Dietary Fatty Acids As Complementary Therapy in Type 2 Diabetes Mellitus

The purpose of the study is to see how a dietary oil called conjugated linoleic acid, or CLA, might be useful in combination with diabetes medication. Some studies show that CLA can modestly reduce body weight and body fat. Our research idea is that taking CLA will reduce body weight and body fat without interfering with the diabetes medications' effects on blood sugar.

The long term goal of this research is to develop effective complementary strategies to aid in the management of type 2 diabetes (T2DM). Our central hypothesis is that CLA reduces body weight and body fat mass when administered concomitantly with oral diabetes medication, The rationale of this study is that using CLA to reduce body weight and body fat in people with T2DM may improve efficacy and longevity of the oral diabetes medications in the management of T2DM. We plan to test our central hypothesis and accomplish the overall objective of this research by pursuing the following three specific aims.

Specific Aim 1: Determine the ability of CLA to reduce body weight and body fat mass in people using oral diabetes medication for management of T2DM.

Specific Aim 2: Determine the ability of CLA to modulate insulin sensitivity when combined with oral diabetes medication.

Specific Aim 3: Determine the safety and tolerability of CLA in combination with oral diabetes medication.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 diabetes mellitus
* HbA1c ≤ 9%
* Overweight or obese (BMI ≥ 25 kg/m2 and ≤ 45 kg/m2)
* Age ≥ 30 and ≤ 70 years (postmenopausal if female)
* Stable medical therapy for past 3 months
* Stable body weight (within ± 2 kg) for past 3 months
* Plans to remain in the Columbus, OH metropolitan area for at least 1 year

Exclusion Criteria:

* Substance abuse
* Current use of prescription or over-the-counter medications or supplements known to affect body composition
* Current use of prescription or over-the-counter medications or supplements known to interact with thiazolidinediones(TZDs)
* Current or previous diagnosis of congestive heart failure
* Self-report of claustrophobia
* Abnormal liver function
* Impaired cognitive function
* Current or previous diagnosis of renal disease
* Gastrointestinal diseases or disorders
* Current use of hormone therapies, or use within the past 3 months
* Discontinuation of diabetes medication
Randomised Controlled Trial PFC Versus CKS Total Knee Prostheses

The purpose of this study is to compare the functional outcome of two different total knee prostheses in a prospective randomised study.


Eligibility Criteria:
Inclusion Criteria:

All patients on the waiting list for a TKA due to an invalidating gonarthrose as a result of osteo-arthrosis or secondary to a rheumatic disease or a trauma.

Exclusion Criteria:

* patient suffering from juvenile rheumatic disease
* patient suffering hemophilia
* patient on the waiting list for posterior stabilized TKA or hinge joint.
* patient who suffers from a lesion of the ligaments due to surgery
* patient who is legally not capable to make decisions
* patient who suffer from cancer
Preventing Alcohol Withdrawal With Oral Baclofen

The purpose of this study is determine if the medication baclofen can prevent the symptoms of Alcohol Withdrawal Syndrome (AWS) in hospitalized patients who may be at risk for AWS. This medication is most often used for patients who have spasticity of their muscles due to a neuromuscular disease. In several European studies, and in an earlier study at Essentia Health (NCT00597701), baclofen has been found to have a significant effect on the severity of symptoms of AWS.


Eligibility Criteria:
Inclusion Criteria:

* Adults (\>21) admitted to inpatients units of 1 of 3 Essentia Health hospitals
* Patient placed on AWS watch protocol by admitting physicians.

Exclusion Criteria:

* Unable to provide informed consent
* Unable to take swallow oral medications (tube-fed patients are to be excluded)
* Admitted for AWS or with Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) score \>8 at baseline
* No alcohol intake for ≥ 48 hours or AUDIT score \<12 at baseline
* Baclofen use at baseline
* Baclofen sensitivity
* Hospital discharge anticipated in within 48 hours
* Pregnant or breast feeding (urine pregnancy test required of women of child-bearing potential)
* Other active drug dependence (except tobacco)
p53 Gene Therapy in Treatment of Diabetes Concurrent With Hepatocellular Carcinoma

An open-labeled phase II study to investigate preliminary efficacy using p53 gene therapy in treatment of diabetes concurrent with hepatocellular carcinoma (HCC).

It was found in the treatment of HCC using p53 gene therapy that the concurrent diabetes was controlled as well. The objectives of this study are to investigate both anti-diabetic and anti-tumor role of p53 gene therapy. This is an open-labeled, randomized, active-controlled phase 2 study. p53 will be injected via the artery, which supplies blood for the tumor nodules. The study endpoints for anti-diabetic role are fasting plasma glucose (FPG), postprandial glucose (PPG) and glycosylated hemoglobin (A1C) at 30 days after the start of treatment; and for antitumor effect are progression-free survival and overall survival.

Eligibility Criteria:
Inclusion Criteria:

* histopathologically diagnosed unresectable HCC
* over 18 years old
* with an Eastern Cooperative Oncology Group (ECOG) score of 0-2
* with Barcelona Clinic Liver Cancer (BCLC) Stage of B or C
* with Child-Pugh score A or B; with normal tests of hemogram, blood coagulation, liver and kidney function
* signed the informed consent form.

Exclusion Criteria:

* hypersensitive to study drug
* With an abnormal coagulation condition or bleeding disorder
* infections
* with serious conditions which prevent using the study treatment
* pregnant or lactating
Fibres Supplementation in Rheumatoid Arthritis

Design: Randomized, double-blind, placebo-controlled study with 4 weeks of treatment with either fiber supplements or placebo.

Primary outcome: variation in SCFA between baseline and week 4. Secondary outcomes : variations in gut microbiota, disease activity (DAS28, RAID), immune cells (regulatory T and B cells, Th17) and heart-rate variability.

Population: 29 patients with rheumatoid arthritis treated with only csDMARDs and a moderate disease activity will be recruited in each arm and 29 controls with mechanic disease (osteoarthritis, tendinitis).

Collection: Blood, feces, disease activity and heart rate variability will be collected at baseline and week 4.


Eligibility Criteria:
General

Inclusion criteria:

* Aged 18 to 85
* Be affiliated to or beneficiary of a French social security scheme
* o No desire for pregnancy for the duration of the study (Effective contraception for women of reproductive age, for the duration of the study (surgical sterilization, hormonal contraceptives, barrier method, intrauterine device))

Exclusion criteria:

* Lack of written informed consent after a period of reflection
* Patient involved in other research or research for which the exclusion period has not ended
* Pregnant or nursing woman
* Type I or II diabetes
* Patient receiving more than 10 mg/d corticosteroids at time of inclusion
* Patient who received corticosteroid infusions in the month prior to randomization
* Unusual consumption (\>50% higher than usual consumption) of dietary fibre in the last 72 hours (assessed by food questionnaire)

Patient with Rheumatoid polyarthritis

Inclusion criteria:

* Rheumatoid arthritis meeting ACR/EULAR 2010 criteria
* With moderate clinical activity: DAS28-CRP 3.2 and 5.1
* Patient receiving conventional background treatment at stable doses and should not be modified during 4-week follow-up

Exclusion criteria:

* Patient treated by targeted RA treatment in the year prior to inclusion
* Patient who received antibiotic therapy within 3 months prior to randomization

Control subjects

Inclusion criteria:

* Patient consulting in the rheumatology department for a mechanical pathology: osteoarthritis of the limbs or spine, osteoporosis, tendinopathy, fibromyalgia, algodystrophy or capsulitis.
* Matched to a gender and age PR topic 5 years

Exclusion criteria:

· Patient with autoimmune disease, infection or progressive cancer
Colchicine in Percutaneous Coronary Intervention

Inflammation in the arteries of the heart may increase the risk of cardiac death. The proposed research seeks to identify the potential beneficial role of a safe anti-inflammatory medication, colchicine, on reducing damage caused by opening up a blockage in the arteries of the heart. With its quick onset of action and excellent safety profile, colchicine may have the potential to reduce risk of major adverse events related to the heart. This research also seeks to better understand the role of neutrophils, the most common type of inflammatory white blood cell in the body, when there is damage to the heart.

The investigators will use colchicine as a tool to elucidate the role of neutrophil activation during acute vascular injury, and to explore the association between neutrophil activation and adverse cardiovascular outcomes. Colchicine reduces cell surface expression of selections, adhesion molecules key to neutrophil recruitment after vascular injury. Daily colchicine use is associated with reduced adverse cardiovascular events in stable atherosclerosis. Using a clinical percutaneous coronary intervention (PCI) model, the investigators evaluate whether pre-procedural colchicine (1.8 mg oral load over one hour) reduces the rate of post-PCI adverse cardiovascular outcomes in the context of a double-blind placebo-controlled randomized study. The investigators will also characterize neutrophil biology in acute vascular injury and the effects of colchicine on neutrophil biology in this setting.

Eligibility Criteria:
Inclusion Criteria:

* Referred for possible PCI

Exclusion Criteria:

* Colchicine use within 1 month
* History of colchicine intolerance
* Glomerular filtration rate \<30mL/minute or on dialysis (due to the need to adjust colchicine dose in this setting)
* Active malignancy or infection (major confounder with increased inflammatory markers)
* History of myelodysplasia (due to suggested cautionary use of colchicine in this setting)
* High-dose statin load \<24 hours prior to procedure (major confounder that is known to reduce inflammatory levels in 12 to 24 hours)
* Use of anti-inflammatory agents (except aspirin) within 5 halflives of the individual drug
* Use of strong Cytochrome P450, Family 3, Subfamily A, Polypeptide 4 (CYP3A4) and/or P-glycoprotein inhibitors (e.g. ritonavir, ketoconazole, clarithromycin, cyclosporine, diltiazem and verapamil, again due to drug interactions)
* Unable to consent
* Participating in a competing study
* Any significant condition or situation that may put the subject at higher risk, confound the study results or interfere with adherence to study procedures
The Effects of Adding Expiratory Muscle Strength Training in Voice Therapy

Evaluate if adding expiratory muscle strength training to traditional voice therapy for individuals with dysphonia due to glottal insufficiency improves maximal expiratory pressure, acoustic and aerodynamic measures (i.e. amplitude, maximum phonation time, peak expiratory flow), and voice related quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with glottic insufficiency.
* Adequate cognition evidenced by score of 24 or higher on the Mini-Mental State Examination (MMSE) survey to determine if the subject has the mental capacity to participate in therapy
* Completed voice combination evaluation with speech pathologists and otolaryngologist.
* Individuals 18 years of age or older

Exclusion Criteria:

* Adults unable to consent
* Non English or Spanish speakers
* Pregnant women
* Prisoners
* Individuals with significant uncontrolled chronic and progressive respiratory diseases including COPD, interstitial lung disease, and cystic fibrosis.
* Individuals with uncontrolled blood pressure.
* Individuals with significant GI disease and/or gastroesophageal surgery with the exception of well-controlled GERD.
* Individuals with a history of abdominal hernia.
* Individuals with difficulty complying due to neuropsychological dysfunction (e.g., severe depression, psychosis).
* Individuals with other neurological disorders and/or neuromuscular disease other than Parkinson's Disease
Socket Preservation With Er:YAG and Nd:YAG Lasers

Alveolar bone regeneration after laser-assisted extraction will be compared with bone regeneration after standard extraction procedure.


Eligibility Criteria:
Inclusion Criteria:

* Patient requires at least one simple extraction
* Voluntary informed consent to participate in the study

Exclusion Criteria:

* Pregnancy
* Use of photosensitizing medication
* Refuse participation
* Require complicated extraction