cyrilzakka/clinical-trials huggingface dataset:
Anthocyanin Intake on Cardiometabolic Biomarkers

Flavonoids are one of the main groups of polyphenols. Anthocyanins, which are a subgroup of the flavonoid family, are found in a number of fruits and some vegetables. In epidemiological studies, high dietary intake of polyphenols has been associated with improvement of some cardiometabolic risk factors in high-risk individuals. Furthermore, in controlled studies, consumption of polyphenol-rich food sources or anthocyanin extract supplementation has improved some cardiometabolic factors. In the present study, the effect of diet enriched with anthocyanin-rich food sources on cardiometabolic factors will be studied in coronary artery disease patients.

This study is an unblinded randomized controlled clinical trial. In this study, among the patients referred to Shahid Modares Hospital (Tehran, IRAN), those who are willing to participate and have inclusion criteria will be recruited. Inclusion criteria are coronary heart disease with recent coronary angiography, age range of 30-75 years. Exclusion criteria are end-stage renal disease, patients undergoing chemotherapy or radiotherapy, patients with inflammatory bowel syndrome, patients being treated with glucocorticoid drugs or antibiotics. Patients are randomly assigned to one of two study groups, including the control group and the group consuming food sources rich in anthocyanin in the diet. The duration of the study will be 8 weeks. In the control group, a general recommendation related to a healthy diet such as reducing the intake of saturated fats, sodium, and simple sugars, is provided. In the anthocyanin-rich diet group, the weekly food plan aims to increase the consumption of anthocyanin-rich sources such as berries, black grapes (or currants), cherries, strawberries, pomegranates, and red onions. The patients' drug regimen will not change during the study. Patients are asked not to use over-the-counter herbal medicines and nutritional supplements during the study. At the beginning and end of the study, blood,

Eligibility Criteria:
Inclusion Criteria:

* coronary heart disease with recent coronary angiography

Exclusion Criteria:

* End-stage renal disease,
* Patients undergoing chemotherapy or radiotherapy,
* Patients with inflammatory bowel syndrome
* Patients being treated with glucocorticoid drugs or antibiotics.
Allogeneic Tumor Cell Vaccination in Patients With Solid Tumors

The goal of this study is to apply allogeneic tumor cell vaccination for immunotherapy in patients with micro-metastatic disease and/or in patients at high risk disease progression. The present study will use allogeneic tumor cell lines for tumor cell vaccines that share MHC determinants with the patient aiming to overcome possible restriction of antigen presentation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with measurable metastatic disease or disease resistant to chemotherapy or with minimal residual disease at high risk to relapse.

Exclusion Criteria:

* Karnofsky less than 60%. Unrelated condition requiring the use of any cytotoxic agents or immunosuppressive agents which may interfere with optimal immune response.
Interval Training and Performance in Mountain Bikers

The aerobic fitness is important for mountain bikers, but riders should also be able to generate maximal and supramaximal efforts in some crucial phases of the competition. Although there is an increase interest in high-intensity aerobic training, to investigators knowledge, there are no studies examining the effects of interval (INTV) or intermittent training (INTM) in mountain bikers. The aim of this study was to compare the effects of INTV and INTM on aerobic fitness variables (peak power output, Wmax, lactate threshold, and onset of blood lactate accumulation) but more importantly on performance as measured using a controlled mountain bike race, i.e. simulation. The investigators hypothesized that INTV and INTM training were equally effective in improving Wmax, Lactate threshold and onset of blood lactate accumulation, but INTV was superior in enhancing performance in mountai bike race simulation.This hypothesis is due to studies that have shown higher gains in performance with long duration of aerobic high intensity interval training in comparison to the shorter training at a higher intensity.

The study is a controlled and randomized trial.

Eligibility Criteria:
Inclusion Criteria:

* Specific training in the mountain bike sport

Exclusion Criteria:

* Use of pharmacological substances
Ozone Injection for Shoulder Impengement Syndrome

Ozone injection has lately been utilized as a safe alternative to corticosteroids in the management of musculoskeletal diseases with fewer side effects. This study aimed to compare the effectiveness of a corticosteroid, single dose and three doses of ozone injection in shoulder impingement syndrome (SIS).

A hundred and eight SIS patients were divided into three groups and underwent subacromial injections in this prospective study. Group 1 received a single dose (n:36), group 2 (n:36) received three doses of ozone injection (n :36). Group 3 (n:36) was treated with a corticosteroid injection. Patients were evaluated using the visual analog scale (VAS) and Constant Murley Score (CMS), pre-injection and at 4 weeks and 12 weeks.

Eligibility Criteria:
Inclusion Criteria: patients older than 18 years with shoulder pain lasting for more than three months, pain severity more than 5/10 on Visual Analog Scale (VAS), and diagnosed with SIS according to clinical examination and magnetic resonance imaging (MRI), were enrolled in this randomized clinical study.

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Exclusion Criteria: The exclusion criteria were as follows: existing pathological abnormalities such as full-thickness rotator cuff tears on MRI, any cause of shoulder pain other than SIS such as inflammatory joint diseases, shoulder osteoarthritis and adhesive capsulitis, restriction of shoulder range of motion, coagulation disorders or use of anticoagulants, previous history of shoulder trauma, surgery or fracture, history of any subacromial injection or physical therapy for the last year, contraindications for ozone injection such as known Glucose 6 phosphate dehydrogenase deficiency, pregnancy, uncontrolled hyperthyroidism, and leukemia.

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Effects of Elastic Band Resistance Exercise on Muscle Strength and Depression in Hospitalized Elderly.

With improved a five-day intensive, low-resistance elastic band exercise program to evaluate its effectiveness in improving total muscle mass, upper and lower extremity muscle strength, self-perceived fear of falling, and depression among hospitalized elderly individuals. This study is a random control trial. Data collection includes elderly patient's total muscle mass, upper and lower extremity muscle strength, self-perceived fear of falling, and depression among hospitalized. The total muscle mass and upper and lower extremity muscle strength will be calculated in kilograms.

Investigators have designed a five-day intensive, low-resistance elastic band exercise program to evaluate its effectiveness in improving total muscle mass, upper and lower extremity muscle strength, self-perceived fear of falling, and depression among hospitalized elderly individuals.

Investigators will enroll individuals aged 65 hospitalized elderly. participants will be randomly assigned to either the experimental or control group. The experimental group will undergo a five-day resistance exercise program using elastic bands, with two 20-minute sessions per day (totaling 200 minutes). The program aims to improve muscle mass and strength. Non-invasive instruments will be used to measure muscle mass and strength, and participants will complete self-report questionnaires on fear of fall and geriatric depression.

Eligibility Criteria:
Inclusion Criteria:

1. Age of 65 years or older.
2. Anticipated hospital stay exceeding 7 days.
3. Able to follow instructions.
4. Four-limb muscle strength of at least three points, and grip strength measurements with a minimum of 26 kilograms for males and 18 kilograms for females.

Exclusion Criteria:

1. This includes individuals with cardiovascular diseases such as acute myocardial infarction, unstable angina, poorly controlled arrhythmias, complete atrioventricular block, acute heart failure, acute myocarditis, acute pericarditis, and other cardiac conditions.
2. Poorly controlled hypertension, with systolic blood pressure less than 90 mmHg or greater than 200 mmHg under medication.
3. Individuals hospitalized due to acute neurological injuries or conditions, such as epilepsy, stroke, or Parkinson's disease.
4. Diagnosed with cognitive impairment or Alzheimer's disease.
5. Those who require long-term ventilator support and are unable to participate in the program.
6. Individuals with impaired consciousness who cannot cooperate.
7. A Glasgow Coma Scale score of less than 12, or inability to correctly answer questions about person, time, place, or follow instructions.
A Study to Assess Etoricoxib Versus Diclofenac in Chinese Patients With Osteoarthritis of the Knee or Hip (0663-080)(COMPLETED)

A Study to Assess Etoricoxib versus Diclofenac in Chinese Patients with Osteoarthritis of the Knee or Hip


Eligibility Criteria:
Inclusion Criteria:

* Chinese males or females at least 40 years of age with osteoarthritis of the knee or hip
Relationship Between Natural Killer Cells' Ability to Kill Leukemia Cells and the Outcome of Patients With Acute Myeloid Leukemia Previously Treated With Interleukin-2

RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the laboratory may help doctors predict response in patients previously treated with interleukin-2.

PURPOSE: This laboratory study is looking at the relationship between natural killer cells' ability to kill leukemia cells and the outcome of patients with acute myeloid leukemia previously treated with interleukin-2.

OBJECTIVES:

* Correlate the in vitro lysis of autologous pre-treatment leukemic blast cells by interleukin-2 (IL-2)-expanded natural killer (NK) cells with relapse-free survival of patients with acute myeloid leukemia (AML) who were treated with interleukin-2 (IL-2).
* Correlate the expression of inhibitory (MHC class I) and activating ligands on AML blast cells with relapse-free survival of these patients.
* Correlate the expression of activating and inhibitory NK receptors on IL-2-expanded cells with relapse-free survival of these patients.
* Compare the susceptibility to autologous NK cell lysis of leukemic blasts obtained at diagnosis with those blasts obtained at relapse of these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to age (\< 60 vs ≥ 60 years) and cytogenetic risk category (favorable vs average vs poor).

Previously banked tissue samples of leukemic blast cells from bone marrow and natural killer (NK) cells from peripheral blood mononuclear cells are thawed and analyzed. Surface expression on leukemic blasts of co-stimulatory molecules, known activating NKG2D ligands, and MHC class I inhibitory ligands to NK cell receptors are quantified by monoclonal antibody analysis and flow cytometry. Mean cell fluorescence intensity (MCFI) of each ligand is correlated with relapse-free survival of the patients.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of acute myeloid leukemia
* Prior treatment with interleukin-2 required
* Previously enrolled on CLB-9621, CLB-9720, or CALGB-19808
* Previously consented to companion Leukemia Tissue Bank Protocol CALGB-9665 and stored the following specimens:

  * Bone marrow blast cells procured at diagnosis and at relapse (when available)
  * Peripheral blood mononuclear cells obtained in remission

PATIENT CHARACTERISTICS:

Age

* 15 and over
Twelve Month Follow-Up of CP0108

The purpose of this study is to determine the long-term safety and efficacy of Levulan PDT in subjects with multiple actinic keratosis of the upper extremities who received treatment as part of the DUSA CP0108 study.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have been enrolled in the DUSA-CP0108 study, completed their assigned treatment and Visit 6 (Week 12).
Comparative Study of the Wear of Uncemented Acetabular Conventional Polyethylene and X3 in Total Hip Replacement, for Stereo-radiographic Analysis

Total hip arthroplasty (THA) is one of the most effective medical procedures. Except for the few early complications (acute infections and dislocations), the patient made a PTH can be assured of a significant improvement in its function and its short-term quality of life. However, clinical studies and records have shown that the lifetime of these implants was limited. The main cause of failure is the "aseptic loosening" influenced by many factors, foremost of which is due to periprosthetic osteolysis debris. This is a major concern for orthopedic surgeons loosening leads, in most cases, the recovery, the importance of osteolysis is a major cause of difficulties and poorer results.

The main objective of the study is to compare, 2 years after the intervention, the penetration of the femoral head in the polyethylene and X3 in the acetabulum in N2VAC® conventional polyethylene.


Eligibility Criteria:
Inclusion Criteria:

* Patient (18-70 years) with hip disease necessitating the establishment of a total hip replacement

Exclusion Criteria:

* Patient aged 71 or more
* Pregnant woman or wishing to be for the duration of the study
* Resumption of total hip replacement, or cephalic prosthesis cups
* Primary or secondary malignant neoplasm of the hip
* Protected adult patient
[11C]Carfentanil PET Study of GSK1521498

The purpose of this study is to determine whether GSK1521498 attaches to sites in the brain called mu-opioid receptors that are involved in the liking reactions to palatable high fat and high sugar foods. We hope that blocking these receptors may modify certain behaviours that may lead to obesity.

This imaging study will be an open-label, non-randomised PET receptor occupancy study in healthy male volunteers. The degree and time course of μ-opioid receptor occupancy (RO) following single oral doses of GSK1521498 will be estimated by \[11C\]carfentanil displacement. Previous pre-clinical and human PET studies indicate that \[11C\]carfentanil is selective for the μ-opioid receptor and can be used to estimate μ-opioid receptor occupancy in vivo.

The PK/PD relationship between plasma concentrations of GSK1521498 and μ-opioid RO will be described. Potential relationships between μ-opioid RO and functional magnetic resonance imaging (fMRI) endpoints, measured in a food reward paradigm, will be assessed as an exploratory aim. Additionally, the PK/PD relationships between plasma concentrations of naltrexone (a generic μ-opioid receptor antagonist), μ-opioid receptor occupancy, and fMRI measures of reward processing will also be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects aged between 25 and 65 years old inclusive.
* Body weight ≥ 50 kg and BMI within the range 18.5.0 - 30.0 kg/m2 (inclusive).
* Normal ECG.
* The subject is able to read, comprehend and record information.
* A signed and dated written informed consent is obtained from the subject.
* Compliance with birth control methods as described in the study protocol.

Exclusion Criteria:

A subject will not be eligible for inclusion in this study if any of the following criteria apply:

* The subject has a positive pre-study drug/alcohol screen.
* History of hepatitis B and /or C
* A positive result for an HIV test.
* Abnormal thyroid function
* Positive evaluation for depression.
* History of heavy alcohol use as described in the study protocol.
* The subject has participated in a clinical trial and has received an investigational product within: 90 days.
* Participation in other drug studies within a calendar year.
* Use of prohibited medications as described in the study protocol.
* History of sensitivity to any of the study medications.
* Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period
* Unwillingness or inability to follow the procedures outlined in the protocol.
* Past or present use of tobacco products.
* Consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication.
* Previous radiation dosages in excess of levels acceptable to take part in this study.
* History of claustrophobia or history of neurological conditions.
* Presence of a cardiac pacemaker.
* Works as a welder, metal worker or machinist
I-beam and Cruciate Tibial Components Used in Total Knee Replacement

The purpose of this study is to compare the clinical outcomes of using an I-beam or cruciate tibial component in total knee replacement.


Eligibility Criteria:
Inclusion Criteria:

* Patients with painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartment are involved.
* Patients requiring correction of varus, valgus, or posttraumatic deformity
* Patients requiring correction of revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

Exclusion Criteria:

* Patients with infection, sepsis, or osteomyelitis.
Hydrogen Peroxide and Nitrite Reduction in Exhaled Breath Condensate of COPD Patients

The aim of the study is to investigate the effect of inhaled apocynin on ROS (reactive oxygen species) and NOS (reactive nitrogen species) synthesis in 13 COPD patients. Effects of nebulized apocynin (0.5 mg/ml, 6 ml) were assessed in exhaled breath condensate (EBC) after 30, 60 and 120 minutes.

Apocynin reduced hydrogen peroxide concentration in exhaled breath condensate 60 and 120 minutes after apocynin nebulization comparing to placebo (0.43 μM vs. 0.59 μM and 0.41 μM vs. 0.58 μM respectively, p\<0.05). Interestingly, apocynin caused decrease of NO2- concentration 30, 60 and 120 minutes after apocynin inhalation (3.9 μM vs. 4.5 μM, 3.8 μM vs. 4.5 μM and 3.7 μM vs. 4,4 μM respectively, p\<0.05) comparing to placebo, but did not cause any significant changes in concentration of NO3- in any timepoint (p\>0.05). No influence of apocynin on safety parameters, and no adverse effects has been observed.

Eligibility Criteria:
Inclusion Criteria:

* patients suffering from bronchial COPD (II and III stage)
* patients free of any medication few days before research
* patients had not suffered from any infectious diseases including upper respiratory tract infections for at least 3 months prior to the study

Exclusion Criteria:

* Patients suffering from GOLD I stage
* patients taking medications few days before the study
* infectious diseases that had occurred 3 months or less before the study
Food Survey, Curbside, Remote APPs SCFI

The proposed research will create accurate and standardized household food waste measurement technologies that foster serial and longitudinal assessments as well as confident and convenient one-time measurement. The investigators propose the SCFI field study where participants simultaneously deploy 3 measurement approaches (1) retrospective surveys (2) curbside audits, and (3) the FoodImage smartphone app.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female, age 18-64 years
* Willing and able to store household food waste for curbside pickup by a third-party waste pickup company
* Internet or Wi-Fi availability to complete online surveys
* Ownership of an IPhone 9s or later, operable Apple ID, password, and email address that they are willing and able to use to collect data during the study. Subject acknowledges data usage and associated charges are a result of study
* Willing to complete all study procedures and adhere to study visit timelines

Exclusion Criteria:

* Not willing to adhere to study procedures and study visit timelines
* Any condition or circumstance that in the judgement of the PI could interfere with study participation
The Effect of Balance PD Solution on the Peritoneal Membrane in Patients on Automated Peritoneal Dialysis

To investigate the biocompatibility of the peritoneal dialysis (PD) solution balance in comparison to the conventional PD solution in APD(automated peritoneal dialysis) patients using the APD cycler sleep•safe.

Equivalence of the investigational PD solution balance regarding fluid status compared to the conventional PD solution.

Effects of balance on inflammation and systemic advanced glycation end products formation.

Effects of balance on peritoneal and total urea clearance, on peritoneal and total creatinine clearance and on ultrafiltration, on residual diuresis and on cholesterol levels.

Safety of the investigational PD solution balance and the conventional PD solution as a control drug.

The mesothelial cell mass assessed by Cancer Antigen 125 is affected by the use of the type of PD solution in APD patients using sleep•safe. Treating patients with the PD solution balance leads to not more than 1 litre difference in hydration in comparison to the conventional PD solution which is considered as clinically not relevant regarding blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* APD patient ≥ 18 years
* Prevalent patient with at least 3 months experience on APD prior to inclusion
* Patient is trained on and being treated with the sleep•safe APD cycler
* Patient treated on APD exclusively with registered conventional PD solutions CAPD 2, CAPD 3, CAPD 4, CAPD 17, CAPD 18 or CAPD 19 for at least 8 weeks prior to inclusion
* Patient is on stable diuretic treatment e.g no change in diuretic treatment within the last 30 days prior to inclusion
* Informed consent signed and dated by study patient and investigator/authorised physician
* Ability to understand the nature and requirements of the study

Exclusion Criteria:

* Peritonitis treatment £ 4 weeks preceding inclusion
* APD patients treated with IPD modality (intermittent peritoneal dialysis)
* Malignant disease without remission
* Patients with artificial joints, amputations, stents, or pacemaker
* Patients with congestive heart failure or coronary artery disease NYHA (New York Heart Association) III and higher
* Active HBV (hepatitis B virus)or HCV(hepatitis C virus)infection- HIV positive
* Participation in an interventional clinical study during the preceding 30 days
* Any condition which could interfere with the patient's ability to comply with the study