cyrilzakka/clinical-trials huggingface dataset:
Good Bowls: Eat Well At Work

The goal of this clinical trial is to improve the health of blue-collar workers by providing subsidized healthy meals supported by nutrition education and behavioral nudges using mobile health and Bluetooth technology.

The aim of this study is to:

Randomize 240 individuals in 8-10 worksites to either Good Bowls alone or Good Bowls + Phone App nudges. Using a crossover design, the primary outcome is the score on a validated Mediterranean diet screener, with secondary outcomes including weight, blood pressure, carotenoid levels, and food security.

Participants: Blue-collar workers in rural manufacturing plants.

Procedures: Workers will be recruited from 8-10 worksites who will be initially randomized within each site to Good Bowls alone or Good Bowls + Phone App nudges. Initial assignment will be followed for four months, after which the groups will crossover for the subsequent four months. The investigators will collect survey data as well as some physiologic measures including skin scanning (non-invasive), weight, and blood pressure. Effects between groups will be determined.


Eligibility Criteria:
Inclusion Criteria:

* Employed at blue-collar worksite
* No plans to move from the area for at least 1 year
* Free living to the extent that participant has control over dietary intake
* Willing and able to provide written informed consent and participate in all study activities

Exclusion Criteria:

* Severe food allergies
* Advanced kidney disease (estimated creatinine clearance \< 30 ml/min)
* Known psychosis or major psychiatric illness that prevents participation with study activities
* Cognitive impairment, frailty, or other disability such that individual cannot fully participate in study activities
Plasma Metabolic Biomarkers for Gastric Cancer Diagnosis

The aim of this observational study is to comprehensively analyze the metabolites in plasma samples from gastric cancer patients using advanced mass spectrometry detection technology, in conjunction with both broad-spectrum and targeted metabolomics approaches. The goal is to construct a dedicated plasma metabolite database for gastric cancer patients. Simultaneously, we will delve into the exploration and validation of a series of metabolic biomarkers for early gastric cancer diagnosis. The objective is to establish a safer, more convenient, and more sensitive early screening method, thereby providing a reliable scientific foundation and critical evidence for improving the early diagnostic process for individuals at high risk of gastric cancer.

Firstly, a wide-targeted metabolomic measurement will be conducted on plasma samples from the discovery cohort to identify potential metabolite candidate markers and construct a gastric cancer patient-specific metabolite database with extensive metabolite information.

Secondly, a more precise targeted metabolomic measurement will be conducted in the modeling cohort. Bioinformatics methods will be used to conduct an in-depth analysis of a wide range of metabolite information to screen out metabolic marker combinations with high gastric cancer-specific diagnostic efficacy.

Ultimately, an external validation cohort will be introduced to validate these metabolic biomarkers, aiming to ensure reliability and stability across different patient populations.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of gastric cancer or benign gastric diseases through gastroscopy and pathological examination.
* Collection of plasma samples prior to surgical treatment.
* Availability of complete clinical data.

Exclusion Criteria:

* Previous reception of anti-tumor treatments (including radiotherapy, chemotherapy, etc.) before blood collection.
* Coexistence of other systemic tumors.
* Absence of plasma sample collection before surgical treatment.
* Incomplete clinical data.
* Pregnancy status.
Management of Bone Metastases

Bone metastases (BM) are responsible for various bone events such as pathological fractures, spinal cord compression, preventive bone surgery, and severe bone pain requiring palliative radiotherapy management. Bone-targeted treatments, such as DENOSUMAB and bisphosphonates, are approved for preventing bone events caused by BM in patients being treated for metastatic cancer.

Clinical research on solid tumors has shown a reduction in the incidence of bone events with these treatments. Given this demonstrated effectiveness, it is important to optimize patient management by studying the characteristics of treated versus untreated patients, the incidence of bone events, and the impact of these events on patients.

A first nationwide study using EGB data (1/97th of the population) showed a low rate of management with bone-targeted treatment. Only 9% of patients with BM or a bone event associated with a cancer diagnosis received bone-targeted treatment. To validate and refine these results, we aim to replicate the protocol at Lyon Sud Hospital. Indeed, a greater amount of information will be available to answer the research question, and a number of biases can be avoided.


Eligibility Criteria:
* Inclusion Criteria \* :

  -- Patients with an ICD 10 code for bone metastases: 79.5
  * And/or patients having had a skeletal event (pathological fracture; spinal cord compression; malignant hypercalcemia; bone pain and preventive orthopedic surgery or spine surgery) associated with a diagnosis of oncological pathology
  * Adult patients
  * No opposition
* Exclusion Criteria \* :

  * - Patient hospitalized for a sarcoma during the pre-inclusion period and inclusion
  * Patients with a Long-Term Illiness (LTI) associated with a hospital diagnosis of Kaposi sarcoma over the same period as LTI
  * Patient with a diagnosis of pathological fracture linked to a diagnosis of osteoporosis (M80)
  * Patient under guardianship or curatorship
  * Minor patients
  * Patients not affiliated to the social security system at least 3 years before the diagnosis of MO and during the follow-up period.
  * Patient already diagnosed with known bone metastases in the previous year.
Metabolic Availability of Lysine From Barley in Young Adult Men

Protein is the key determinant of growth and bodily functions. The quality of food proteins depend on their amino acid content and the amount of amino acids used by the body to make proteins. Globally Cereal Grains (CG) provide 50% of the calories and protein in the diet and exceed 80% in poorer developing countries. Barley is an important cereal grain in the diet. The protein in barley is low in the essential amino acid lysine. Hence barley protein is of low quality. Low lysine affects protein synthesis in the body. Cooking methods also affect the lysine available from foods to the body. It is important to assess the effect of different cooking methods on the lysine availability of barley.

Each subjects will receive each of up to 10 experimental diets for the Barley Study (4 reference protein diets providing, 3 Barley diets using dry cooking method, and 3 Barley diets using moist heat cooking method) in random order over a series of up to 10 experimental periods. The reference protein diet will be patterned after the AA pattern of egg protein using crystalline AA as the protein source. Three of the 4 lysine levels will be replaced by lysine provided in Barley each cooked using two different cooking methods ( dry and moist-heat).Each experiment will be conducted over 3 days.

Adaptation days:

During days 1 and 2 the subjects will be adapted to the level of lysine being studied, consuming the same diet as they will receive on day 3 (IAAO study day). The adaptation diet will be consumed as 4 equal meals.Meals will be divided into 4 equal parts to be spread evenly throughout the day and consumed in their usual environment on their usual activities of daily living.

IAAO study day/isotope delivery and sample collection day:

On the oxidation study day 3, following a 12-h overnight fast, subjects will come to the Hospital for Sick Children, Toronto, ON for a period of 5.5 h. On the oxidation study day, the diet is consumed as 9 iso-nitrogenous and iso-energetic hourly meals. Between meals, subjects are allowed to rest on bed, watch television or use a computer. Study days for each participant will be separated by ≥ 1 week. For the duration of all experiments, subjects will consume a daily multivitamin (Centrum Forte, Whitehall Robins) and 500 mg choline supplement (Nature's Way or equivalent), to ensure adequate vitamin intake. The multi vitamin supplement is provided to ensure that no vitamin cofactors are limiting in the diet which could alter metabolic pathways and functioning.

Eligibility Criteria:
Inclusion Criteria:

* Male, age 18 - 40 years, Healthy with no known clinical condition which would affect protein or AA metabolism, ex. Diabetes,
* Stable Body Weight (±0 to 5lb weight gain or loss in the last 3 months)
* Not on any medications that could affect protein or amino acid metabolism e.g. steroids.

Exclusion Criteria:

* Unwillingness to participate or unable to tolerate the diet
* Recent history of weight loss within the last 3 months or on a weight reducing diet Inability to tolerate study diets (ex. Allergy to ingredients).
The Turkish Version of the AOFAS Hallux MTP-IP

The American Orthopedic Foot and Ankle Society hallux metatarsophalangeal-interphalangeal joint scale (AOFAS Hallux MTP-IP) is originally developed in English to evaluate the pain, function and alignment in patients with hallux deformities. The purpose of this study is to translate and cross-culturally adapt the AOFAS Hallux MTP-IP scale into Turkish and investigate its psychometric properties.

The American Orthopedic Foot and Ankle Society hallux metatarsophalangeal-interphalangeal joint scale (AOFAS Hallux MTP-IP) is originally developed in English to evaluate joint function in patients with elbow stiffness. The purpose of this study is to translate and cross-culturally adapt the AOFAS Hallux MTP-IP scale into Turkish and investigate its psychometric properties. Approximately seventy patients with hallux deformities will be included. For cross-cultural adaptation, two bi-lingual translators will use the back-translation procedure. Within a 5-to-7-day period after the first assessment, the participants will complete the Turkish version of AOFAS Hallux MTP-IP (AOFAS Hallux MTP-IP-T) to evaluate test-retest reliability. Cronbach's alpha (α) will use to assess internal consistency. The correlation with the Turkish version of the Manchester-Oxford Foot Questionnaire (MOXFQ) and Short Form-12 will be determined to check the validity.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 65 years
* Diagnosis of Hallux deformities
* Continuing follow-up and treatment in the orthopedic service
* Being able to follow simple instructions
* Being able to read and write in Turkish

Exclusion Criteria:

* Having any cardiovascular diseases, neurological disorders, rheumatic diseases, or psychiatric diseases
* Having peripheral nerve injury, peripheral neuropathy, or sensory loss in the lower extremity
* Having heterotopic ossification, myositis ossification, or post-traumatic ankylosing in the lower extremity
* Fracture, non-healing wound, or infection in the lower extremity
Effects of Respiratory Yoga Training on Heart Rate Variability and Baroreflex of Healthy Elderly Subjects

The decreases of physiological capacities which take place with senescence include diminishing respiratory capacity as well as a reduction of heart rate variability and baroreflex sensibility. Altogether, these alterations increase elderly people's frailty and have a negative impact over quality of life. Since Yoga (Indian auto-discipline) has a wide range of respiratory exercises already investigated as components for non-pharmacological treatments for hypertension (situation in which heart rate variability is also diminished), the investigators hypothesis is that the training of respiratory exercises of Yoga may have a significant positive effect on heart rate variability and baroreflex of health elderly subjects, increasing quality of life and reducing frailty.

We included 30 health elderly subjects (both sexes, from 60 years-old onwards) divided into 2 randomized experimental groups: control (C) and respiration (R). Each group underwent an entry evaluation, followed by a 4-months training period, after which they were re-evaluated. Control consisted of 2 stretching classes per week, and respiration consisted of 2 respiratory exercises classes a week. Both groups were instructed to perform the exercises at home twice a day, and to keep a record of each session in a log sheet. Evaluations were: WHOQOL-OLD questionnaire for quality of life, 20 minutes of seated rest with heart rate, respiration and blood pressure acquired continuously for further spectral analysis.

Heart rate variability was performed using the autoregressive model, and the baroreflex was calculated with the spontaneous approach, both with the softwares developed in Milan by Alberto Porta in a non-invasive way.

The frequency domain analysis of heart rate, respiration and systolic blood pressure were conducted, consisting of calculating the power spectral density with the minimum error predicted by Akaike's algorithm. Spectral power was then subdivided into two bands of physiological interest: low - (LF 0.03-0.15 Hz) indicating predominant sympathetic modulation, and high - (HF 0.15-0.5 Hz) frequency, indicating parasympathetic modulation of the heart. The fraction calculated dividing LF by HF (LF/HF ratio) provided information of sympathovagal balance to the heart. The spectral analysis of Systolic Blood Pressure provided information of the vasomotor tone, and the integration of heart rate information with these data also provided information about the spontaneous baroreflex gain.

Other questionnaires used were: Pittsburgh Quality of Sleep Questionnaire, Stress Symptoms Questionnaire by Marilda Lipp - validated in Brazil, and Beck's anxiety and depression inventories.

Eligibility Criteria:
Inclusion Criteria:

* Health elderly subjects

Exclusion Criteria:

* Use of beta-blockers
* Atrial Fibrillation
* Previous training in respiratory exercises
Lung HeXeRT: Helium, Xenon MRI for NSCLC Patients

The University of Sheffield is one of the leading centres in the world for basic and translational research with inhaled gas MRI, which provides lung images with unprecedented spatial and temporal resolution. Our previous work demonstrated that inhaled gas MRI can provide significant clinical information for lung cancer radiotherapy planning and post-treatment evaluation. Building upon this unique experience, a multidisciplinary team will conduct an inhaled gas and proton lung MRI study that will address two of the major clinical problems faced by lung cancer patients treated with radiotherapy.

1. Normal lung tissue is often damaged by the curative radiation dose. The investigators hypothesise that regional ventilation-perfusion lung function imaging with inhaled gas and proton MRI before and after treatment will help to lower the risk of radiation-induced lung injury and help to detect such damage at an early stage.
2. Identification of the extent of cancerous tissue is error-prone when planning treatment from CT images alone. The investigators hypothesise that advanced proton MRI techniques will improve the identification of tumour volume, which is critical to successfully targeting the radiation dose.

To achieve these goals, image acquisition and image processing methods will be tested with a study of 20 patients. Results from this study will make an important contribution to improving the treatment of lung disease which is one of the key research priorities of the NHS.


Eligibility Criteria:
Inclusion Criteria:

* Patients with an MDT diagnosis of NSCLC based on findings of positive histology, positive PET scan or growth on serial CT scan requiring CT planning for radiotherapy treatment
* patients aged over 18
* patients able to undergo MRI scanning.

Exclusion Criteria:

* patients with co-morbid conditions that exclude radiotherapy treatment
* patients who are pregnant or women with child bearing potential
* patients unable to give informed consent
* patients who do not understand English sufficiently to read the patient information sheet, provide informed consent or converse with research staff without interpreters.
Clinical and Radiological Evaluation of Meniscal Healing After Percutaneous Intra-meniscal Injection of Platelet-rich Plasma (PRP)

Meniscal lesions are a common pathology among athletes, and have an impact on the daily or sporting practice of patients. The consequences of surgical treatment are sometimes heavy.

Platelet-rich-plasma (PRP) has been shown to be effective in healing tendon and ligament lesions.

PRP has been injected under ultrasound in tendons or intra-articularly for several years.

This technique of meniscal percutaneous injection of PRP is now carried out for more than 2 years in our hospital, with satisfactory preliminary results, without any complication.

All patients in our study received an intra-meniscal injection of PRP, under echographic control. They were evaluated clinically and by Magnetic Resonance Imaging (MRI) before and at 6 months of the injection.

The aim of the study is to evaluate the efficacy of intra-meniscal injection of PRP on the symptomatology of the patients (pain, sport activities and daily life) at 6 months post-treatment.


Eligibility Criteria:
Inclusion Criteria:

* isolated symptomatic meniscal lesion
* lesion confirmed by MRI
* grade II or III lesion touching the peripheral involvement of the middle segment,
* lesion treated by percutaneous intra meniscal PRP's injection
* IKDC score measured before injection and 6 months post-injection

Exclusion Criteria:

* other painful etiology of the knee
* emergency surgical management (luxation, bucket handle) or not (indication validated by the surgeon, meniscectomy or meniscal suture)
* impossibility to perform the procedure (non visible lesion, morphology of the patient, cutaneous infection, coagulation treatment in progress)
1L- vs. 4L-PEG for Bowel Preparation Among Inpatients.

Background and aims: Inpatients are at high risk for inadequate colon cleansing. Experts recommend 4L-polyethylene-glycol (PEG) solution because of its effectiveness and safety profile. A higher colon cleansing adequacy rate for a hyperosmolar 1L-PEG plus ascorbate prep has been recently reported in an observational study among more than 1,000 inpatients. Thus, the present study is aimed at determining whether 1L-PEG outperforms 4L-PEG among inpatients, through a propensity score-matching between the two groups in order to correct for confounders.


Eligibility Criteria:
Inclusion Criteria:

* Adult inpatients scheduled for colonoscopy for any indication within the normal process of care.

Exclusion Criteria:

* patients who underwent emergency or elective therapeutic colonoscopies (e.g. polypectomy, endoscopic mucosal resection, endoscopic submucosal dissection)
* patients who underwent bowel preparation outside the hospital
Comparison of an Internet-based Guided Self-help and a Group Therapy for Chronic Tinnitus

The aim of this study is to compare the efficacy of an internet-based guided self-help training for chronic tinnitus with a well-established outpatient group therapy and a discussion forum group.

Chronic tinnitus can result in significant psychological suffering and reduce quality of life. Cognitive behavioral therapy (CBT) has been shown to be effective in decreasing the impairment caused by tinnitus. One recent way delivering CBT is an internet-based self-help intervention. Internet interventions for patients with chronic tinnitus, developed by Swedish scientists, showed promising results (Andersson et al., 2002; Kaldo et al., 2007; Kaldo et al., 2008). The main purpose of this study is to compare the efficacy of this internet-based self-help training for chronic tinnitus with a traditional well-established CBT group treatment and with a discussion forum group in a randomized controlled trial. Secondary goals are a process evaluation of both treatments, the identification of predictors of treatment success, an estimation of the cost-effectiveness of each treatment and the validation of the Tinnitus Cognitions Questionnaire (T-Cog; Hiller \& Haerkötter, 2005).

Eligibility Criteria:
Inclusion Criteria:

* Age of at least 18 years
* Chronic tinnitus for at least 6 months
* Medical examination of tinnitus by an ear, nose and throat physician (ENT)
* Scoring 18 or above on the Tinnitus Handicap Inventory (THI) or scoring 12 or above in the Mini-Tinnitus Questionnaire (Mini-TQ)
* Not currently receiving psychological treatment for tinnitus
* Being able to access the Internet and print instructions
* Sufficient knowledge of the German language to read and follow the internet-based self-help training
* Being able to attend weekly group sessions in the Outpatient Department of the Psychological Institute of the University of Mainz, Germany
* Sufficient time and motivation to work on the treatment programs

Exclusion Criteria:

* Tinnitus caused by any other general medical condition or otologic disease (e.g., active Meniere's Disease)
* Clinical diagnosis of any severe mental disorder (especially a severe depressive disorder, suicidality, acute psychosis)
* Clinical diagnosis of Dementia or another severe organic cerebral disorder
* Clinical diagnosis of substance-related addiction/abuse
Outcomes of Patients After Allo-HSCT With Decitabine and NAC

The investigators will conduct this prospective and randomized clinical trial, to evaluate the hematopoietic reconstitution, GVHD and relapse rate of patients after allo-HSCT with decitabine containing conditional regimen and NAC treatment.

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is the main curative treatment for hematological malignancy. Relapse, graft versus host disease (GVHD) and graft failure are the main causes of treatment failure. Acetylcysteine (NAC) was found to be able to enhance defective HSCs by repairing dysfunctional bone marrow endothelial cells, and overcome the exhaustion of HSCs and enhance the engraftment of HSCs. Decitabine could restore bone marrow microenvironment by repairing endothelial cells and endothelial progenitor cells, as well as cytokines and chemokines which are crucial to HSCs proliferation and differentiation, thereby promote platelet recovery after HSCT. Besides, decitabine therapy was shown to be associated with reduced incidence of GVHD, lower relapse rate, and increased overall survival in several studies. Thereby the investigators will conduct this clinical trial to evaluate the hematopoietic reconstitution, GVHD and relapse rate of patients with hematological malignancy after allo-HSCT with decitabine containing conditional regimen and NAC treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed as hematopoietic malignancy;
2. Achieved complete remission since the last chemotherapy;
3. Age 10-70 years；
4. Be willing to receive allo-HSCT, with HLA matched related or HLA matched unrelated, or HLA mismatched related donor.

Exclusion Criteria:

1. Active infections, severe organ damage (cardiac, renal and/or hepatic dysfunction greater than grade 2 according to the Common Terminology Criteria for Adverse Events V5.0), or any other conditions that make patients ineligible for allo-HSCT;
2. Allergic to acetylcysteine or decitabine.