cyrilzakka/clinical-trials huggingface dataset:
Factors Associated With High Mortality of Gastric Adenocarcinoma in Thailand Versus Japan

The differences in patient's clinicopathological characteristic between high and low prevalence of gastric cancer region should be further examined to elucidate factors that associate with poor survival rate of patients with gastric cancer. Therefore, this study aimed to evaluate characteristics of patients with gastric adenocarcinoma and factors associated with different outcome in Thailand and Japan to find a clue to improve patients' survival in low prevalence country such as Thailand.

This is a retrospective cohort study. It was conducted at King Chulalongkorn Memorial Hospital, Thailand and Osaka Medical Center for Cancer and Cardiovascular Disease, Japan. Eligible cases were selected by using standardized search protocols: formal computer searches of all patients seen at out-patient clinic and/or hospitalized for gastric cancer between 2010 and 2014.Two physicians, who were informed the definition of each variable, individually reviewed chart of patients.


Eligibility Criteria:
Inclusion Criteria:

* all patients seen at out-patient clinic and/or hospitalized for gastric cancer between 2010 and 2014.

Exclusion Criteria:

* Age \< 18 years
* Incomplete data
* Miss diagnosis of gastric adenocarcinoma
* Died from other causes (not related to gastric adenocarcinoma).
Alcohol-Containing Products' Effect on Breathalyzer Results in Healthy Adults Without Acute Intoxication

This study is a prospective, controlled study in healthy volunteers all of whom are residents, medical students, faculty physicians, or emergency department nursing and ancillary staff.

The breathalyzer, BACtrack S80 Breathalyzer, will be calibrated per manufacturer's recommendations before each reading will be taken. Participants will administer the breathalyzer test on themselves. They will be instructed on how to hold and blow into the breathalyzer machine. Participants will then be instructed to wash his or her hands and an initial breathalyzer reading will be taken and will serve as the control prior to the application of each product. Participants with a result \>0 will be excluded from the study. Participants will apply the alcohol-containing product to his or her hands and a second breathalyzer reading will be obtained immediately after application. If the second breathalyzer result is \>0, a third breathalyzer reading will be obtained after the product has dried appropriately on the participant's hands (approximately 1 minute after initial application). A minimum of two breathalyzer readings will be obtained from each participant per product application. If the second breathalyzer reading is \>0, a third breathalyzer will be obtained from that participant.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals between the ages of 18 and 75
* Able to verbally consent
* Residents, medical students, faculty physicians, emergency department nursing and ancillary staff

Exclusion Criteria:

* Inability to consent
* Individuals with an initial breathalyzer result greater than 0.000
* Individuals who have consumed alcohol or used other alcohol-containing products within the last 12 hours
Indirect Calorimetry in Patients at Risk of Malnutrition

Burn patients treated in an outpatient clinic and ICU survivors are at risk of malnutrition. There are no clear guidelines determining the energy target in those two populations. The aim of this observation study is to measure the resting energy expenditure of those patients, using indirect calorimetry.


Eligibility Criteria:
Inclusion Criteria:

* minor burn treated in an outpatient setting
* ICU survivor, who was discharged from ICU after a stay of at least 7 days

Exclusion Criteria:

* oxygen supply
* chest drainage
* not french speaking
* confusion, coma
* cognitive disorder
* patient refusal
The Effect of Different Ketone Supplements on β-OHB and Blood Glucose in Healthy Individuals

Ketone bodies are a fuel source and signaling molecule that are produced by your body during prolonged fasting or if you consistently eat at low-carbohydrate diet. Blood ketones can be used as a source of energy during fasting and are used by your brain as an alternative source of fuel to glucose. Previous studies have found that ketones, when consumed in form of a supplement drink, can increase blood ketone levels and lower blood glucose, the amount of sugar in your blood. This is of potential interest for individuals with high blood sugar, such as people living with type 2 diabetes. However, there are different types of ketone supplements that differ in how they are metabolized in the body. Little is known about how these supplements affect blood ketone and blood glucose levels. The main objective of this study is to determine the effect of three different ketone supplements on blood ketones and blood glucose. The results of this pilot study will be used to guide future research for larger and more extensive studies on ketone supplements.


Eligibility Criteria:
Inclusion Criteria:

* over the age of 18;
* able to fast overnight

Exclusion Criteria:

* being a competitive endurance athlete;
* following a ketogenic diet, low-calorie diet, periodic fasting regimen, or regularly consuming ketogenic supplements;
* being unable to travel to and from the university;
* being unable to follow the diet instructions;
* being pregnant or planning to become pregnant during the study;
* having been diagnosed with a chronic disorder of glucose or fat metabolism, including type 2 diabetes, chronic pancreatitis, or gallbladder disease;
* being unable to read or communicate in English
Use of Dual-light Photodynamic Therapy as an Adjunct to Periodontal Treatment in Smokers

The goal of this controlled clinical trial is to investigate the impact of regular home use of Lumoral device as an adjunct treatment compared to non-surgical periodontitis treatment (NSPT) alone on biofilm removal and host response in Stage III and Grade C smoking periodontitis patients at 6 months.The main question aims to answer is:

• Does regular use of dual-light photodynamic therapy benefit NSPT in Stage III and Grade C smoking periodontitis patients?

30 participants will be asked to use Lumoral device every night before performing oral hygiene for 10 minutes, while the other 30 patients will be asked to perform only oral hygiene. Both of these groups will receive NSPT and will be followed for 6 months from baseline.

The objective of this study is to investigate the impact of regular home use of Lumoral device® as an adjunct treatment compared to non-surgical periodontal treatment alone on biofilm removal and host response in Stage III and Grade C smoking periodontitis patients at 6 months.

Lumoral® is based on a dual-wavelength LED light that activates Lumorinse® (exocellular) and bacteria porphyrins (endocellular), resulting in the formation of reactive oxygen species (ROS). ROS and heat induce a series of photochemical and biological events that cause irreversible inactivation leading to the death of undesired bacteria. This device is designed for home use.

Therefore it is hypothesized that its adjunct use in the treatment of periodontitis could lead to better outcomes compared to traditional periodontal treatment. In order to investigate this impact, clinical and microbiological measurements will be compared between patients who will be treated with conventional non-surgical periodontal treatment and patients who will receive the Lumoral device® as an adjunct to the periodontal treatment. The patients who receive the device will use it every day for four months. Both groups will be followed for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Periodontal disease Stage III and Grade C with at least 6 sites with probing depth (PD) and clinical attachment loss (CAL) ≥5 mm and bleeding on probing (BoP) ≥15 teeth
* aged ≥35
* Smokers smoking ≥10 cigarettes per day

Exclusion Criteria:

* Patients allergic to indocyanine
* Patients with active carious lesions
* Need for prophylactic antimicrobial coverage
* Scaling and root planing in the previous 6 months
* Non-smoking status or smoking less than 10 cigarettes per day
* Antimicrobial therapy in the previous 6 months
* Immunomodifying conditions/ diseases (e.g. diabetes mellitus, rheumatoid arthritis, osteoporosis)
* Long-term use of medication that could interfere with periodontal response (e.g. biphosphonates)
* Pregnancy or lactation
Collection of Human Liver Biopsy and Whole Blood Samples From T1DM, TP or PP Patients for Potential Use for Insulin Producing Cells in Future Clinical Studies

In this study, liver samples will be collected, processed and stored in a specialized, clinical grade, cell bank for potential future clinical use. A set of ex-vivo immunogenicity and transdiffrentiation tests will be carried to confirm the ability of this cryopreserved cell batch to be used as clinical grade raw material. Biopsies will be collected during TP or PP with the assumption that some of the patients (especially PP patients will not go through Islets autotransplantation) will develop brittle diabetes, thus Orgenesis therapy can provide them in the long run, a treatment. In terms of T1DM the purpose is to have available clinical grade raw material for cell replacement therapy.

The collected liver samples will be proliferated (up to passage 4) for future use. A portion of the stored cells will be utilized in a small-scale process to test possible immunogenicity performed on the collected blood sample. The assay will provide data whether immunomodulation treatment will be required in the future clinical trials. Also the transdffrentiated cells (AIPs) will be tested according to release criteria relevant for clinical IPC production. Liver biopsy donors will be contacted upon approval of the consecutive study and will have study recruitment priority. The donors can refuse to participate in the future study or may not need the therapy, however, their biopsies will be stored for a potential use if required, after the therapy is approved.


Eligibility Criteria:
Inclusion Criteria:

* patients between the ages of 18 and 70 years old, inclusive.
* For T1DM - Patients with history of established T1DM undergoing an elective abdominal surgery with an easy access to the liver
* Patients undergoing total or partial Pancreatectomy
* Female patients who agree not to breastfeed during the study up to at least seven days after the study is completed.
* For T1DM - Receiving multiple daily insulin injections or insulin pump therapy.
* For T1DM - HbA1c ≤10%.
* Willing to sign the study informed consent document.
* In good general health with no infections, or concomitant medical conditions that would influence the outcome of the trial, at the discretion of the Investigator and the Sponsor.

Exclusion Criteria:

* Received any investigational product within 30 days of admission into this study or plan to participate in any other clinical study during the conduct of this study.
* Received methotrexate or other rheumatoid disease modifying agents within the last 6 months.
* Administration of a live vaccine 30 days prior to screening.
* No evidence of liver Cirrhosis or Nonalcoholic Steatohepatitis (NASH, grade 3 and above) within the last month.
* Patients diagnosed with liver viral infections such as HBV, HCV, HIV
* Patients diagnosed with CMV (defined by IgM positive).
BNHL-2015 for Children or Adolescents in China

The purpose of this study is to test whether adding 4 injections of rituximab and increasing the intensity of chemotherapy regimens in advanced patients can improve the EFS compared with the historical study CCCG-NHL-2010.

In our previous study (CCCG-NHL-2010), two-year EFS was 100% for Stage I, 91.3% ± 6.1% for Stage II, 75.8% ± 4.4% for Stage III, 56.3% ± 13.5% for Stage IV, and 36.4% ± 14.5% for B-AL, respectively. To improve survival for pediatric patients with B-NHL/B-AL, the investigators launched a new study in China. Compared with our previous treatment regimens (CCCG-2010), patients with stage III and LDH\>4 times NL, any stage IV or B-AL were stratified into R4. The dose of methotrexate was increased to 5000mg/m2 for patients in R3 or R4 (previously 3000mg/m2). Four injections of rituximab was added to the chemotherapy for patients in R4. Our aim is to test whether adding rituximab or high dose of methotrexate (5000mg/m2) would improving 2-year EFS for patients in advanced groups.

Eligibility Criteria:
Inclusion Criteria:

* Histology or cytologically confirmed matureB-cell NHL/AL(Burkitt, DLBCL, PMLBL,or aggressive mature B-cell NHL non other specified or specifiable)
* Able to comply with scheduled follow-up and with management of toxicity
* Signed informed consent

Exclusion Criteria:

* Follicular lymphoma, MALT and nodular marginal zone are not included into this therapeutic study
* Patients with congenital immunodeficiency, chromosomal breakage syndrome, prior organ transplantation, previous malignancy of any type, or known positive HIV serology.
* -Evidence of pregnancy or lactation period.

  * Past or current anti-cancer treatment except corticosteroids during less than one week.

Exclusion criteria related to rituximab:

* Tumor cell negative for CD20.
* Prior exposure to rituximab.
* Hepatitis B carrier status history of HBV or positive serology.
ION US Post-Approval Study

The purpose of this study is to compile real-world clinical outcomes data for the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System in routine clinical practice.

The ION™ stent is the third-generation Boston Scientific (BSC) paclitaxel-eluting coronary stent. It is designed for improved performance specific to deliverability and radio-opacity while maintaining a similar drug release profile of the TAXUS Express and TAXUS Liberté stents. Following PMA approval from the FDA for the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System the ION US Post-Approval study will compile real-world clinical outcomes data for the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System in routine clinical practice. Post-approval studies of drug-eluting stents (DES) provide an opportunity to observe and assess patient outcomes and technology performance in a real-world setting.

Eligibility Criteria:
Inclusion Criteria:

Consented subjects receiving one or more ION(TM)Coronary Stents

Exclusion Criteria:

Subjects not clinically indicated to receive an ION (TM)Coronary Stent
Effect of Using a Lower Limb Robotic Device for Patients With Chronic Stroke

This study will investigate if a lower limb robotic device can be used in a community setting to increase the amount of physical activity that individuals undertake following stroke and consequently improve biomechanical, physiological and health outcomes, in patients with stroke.

Recent advances in technology have helped to develop robotic devices to aid gait training in order to develop more normal movement patterns, strengthen the quadriceps and improve quality of gait. Lower limb robotic devices have been shown to increase functional mobility, walking speed, step length, balance and endurance within a clinical setting. The purpose of this study is to see if a lower limb robotic device leg can be used in a community setting to improve biomechanical (gait, balance, lower-limb strength), physiological (vascular health) and performance outcomes (aerobic fitness, strength) in patients with chronic stroke

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of stroke within 3-60 months
* Community patients that are medically stable and currently receiving therapeutic input from Hobbs Rehabilitation
* Individuals who are able to stand and step with an aid or assistance
* Cognitively aware of task demands
* Height: 5ft 2-6ft 3 (158-192 cm)
* Weight: \<25 stone (\< 159kg)

Exclusion Criteria:

* Unresolved deep vein thrombosis
* Unstable cardiovascular conditions
* Open wounds
* Active drug resistant infection
* Recent fractures of involved limb
* Peripheral arterial disease
* Incontinence
* Severe osteoporosis
* Non weight bearing
Pharmacokinetics, Safety, and Tolerability of Various XW10172 Oral Formulations in Healthy Adult Volunteers

The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of various formulations of XW10172 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male of female participants who are 18 to 55 years of age, inclusive.
* Participant is willing and able to provide signed and dated written informed consent to participate prior to admission to the study.

Exclusion Criteria:

* Evidence or history of clinically significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, psychiatric, neurological, immunological, or endocrine disorders, poor vision, or allergic disease including drug allergies, including immediate type hypersensitivity. A history of childhood asthma that has resolved is acceptable.
* Participant who, for any reason, is deemed by the investigator to be inappropriate for this study; or has any condition which would confound or interfere with the evaluation of the safety, tolerability, pharmacokinetics or pharmacodynamics of the investigational drug; or is unable to comply with the study protocol.
A Study of Nivolumab Combined With Ipilimumab and Nivolumab Alone in Patients With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)

The purpose of this study is to demonstrate the clinical activity of nivolumab in combination with ipilimumab in multiple types of tumors based on their Tumor Mutational Burden status.


Eligibility Criteria:
Inclusion Criteria:

* Participants with a refractory, metastatic, or unresectable histologically or cytologically confirmed solid malignant tumor with high tumor mutational burden (TMB-H) who are refractory to standard local therapies, or for which no standard treatment is available.
* Must be able to provide tissue and blood TMB-H testing results
* Must have measurable disease for response assessment

Exclusion Criteria:

* Participants with melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC) or hematological malignancy as primary site of disease
* Participants who received prior treatment with an anti-programmed death-1 (anti-PD-1), anti-programmed death ligand 1 (anti-PD-L1), anti-programmed death ligand 2 (anti-PD-L2), anti-CD137, or anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
* Treatment with any chemotherapy, radiation therapy, biologics for cancer, or investigational therapy within 28 days of first administration of study treatment

Other protocol defined inclusion/exclusion criteria apply.
CONSTRAINT-INDUCED MOVEMENT THERAPY VERSUS CROSS EDUCATION IN CHILDREN WITH CEREBRAL PALSY

This clinical trial aims to Compare the effectiveness of lower limb CIMT and the Strength Training of the Non-Hemiplegic lower limb on motor performance in hemiplegic children with CP.

Participants will:

diagnosed with hemiplegic cerebral palsy treated with CIMT or Strength training (cross-education) for a non-hemiplegic limb for 8 weeks.

3 sessions per week. Measurements will be taken at baseline and then at the end of the 8 weeks.

Method:

32 children with hemiplegic CP will be equally and randomly allocated to two groups (group A and B). group A will receive lower limb CIMT for the non- hemiplegic limb using whole leg orthosis and Group B will receive strengthen training for the non-hemiplegic lower limb. Both groups will receive routine physical therapy for the hemiplegic lower limb. Both groups will receive 60 minutes training session for 3 sessions per week for 8 consecutive weeks. Assessment will be at baseline then at the end of trial.

Eligibility Criteria:
Inclusion Criteria:

1. Children with hemiplegic cerebral palsy aged age between 4 and 10.
2. (GMFCS) levels I, II and III.
3. Able to follow therapist instructions during training session.

Exclusion Criteria:

1. Lack of patient's cooperation.
2. Difficulty wearing constraint method due to severe joint deformation or/and contracture.
3. Patients were treated with botulinum toxin during the last 3 months.
4. Seizure disorder not fully controlled by medication.
Evaluation of a Binaural Spatialization Method for Hearing Aids

This study investigates the possible benefits of using binaural spatialization techniques in digital wireless microphone systems for hearing aids. Speech intelligibility tests, speaker localization tests and preference tests are performed. The results of a diotic (current rendering) and a binaural (suggested rendering) rendering are compared.

The signal processing laboratory (LTS2) of the Swiss Federal Institute of Technology (EPFL) has developed a new feature of sound rendering in hearing aids. This is a collaboration between EPFL and the Swiss company Phonak Communications AG. The new functionality works with the range of Roger products from Phonak, a new generation of FM systems that use a digital transmission.

FM technology refers to a type of wireless system that helps people better understand speech in noisy situations. FM systems commonly work together with a user's hearing aids, although systems are also available for those with otherwise normal hearing (such as people who suffer from APD, ADHD etc.). An FM system works like this: the person speaking wears or holds a transmitter microphone, or the transmitter is placed in the middle of the group (picking up speech from all around). Using harmless radio waves, the FM system sends speech signal(s) to the listener, who wears a tiny FM receiver behind the ear.

The new feature of such systems performs processing of the speaker's speech signal so that it renders information related to their spatial location. This so-called sound "spatialization" is a natural property of the human binaural auditory system, which allows us to localize sounds. However, this sound spatialization is not delivered by the current FM systems. Thanks to the new technology from EPFL and Phonak, it is now possible to include a binaural spatialization of the speech signal in the Roger product of Phonak hearing devices.

Eligibility Criteria:
Inclusion Criteria

* French-native speakers and adults.
* Normal otoscopy.
* No conductive pathology.
* Normal hearing, or moderate to severe, sloping or flat, symmetrical hearing loss.
* User of bilateral Phonak hearing aids, for more than 6 months (hearing-impaired only).

Exclusion Criteria:

* History of tinnitus or hyperacusis.
* Visual impairment, after correction with glasses or not.
* History of chronic or terminal illness or psychiatric disturbance,.
* History of epilepsy or other reactions associated with the proximity to a video screen.