cyrilzakka/clinical-trials huggingface dataset:
Correlations Between Nutrition and Urine Spot Checks Via a Urinary Self-test

An inclusion consultation carried out by Professor Gamé at the CHU of Toulouse (Rangueil site) will make it possible to provide the subject with a urinary self-test which automatically carries out and sends the measurement of 10 urinary parameters: pH, density, creatinine, magnesium, calcium, sodium, urea, uric aid, oxalate, citrate.

No samples are taken and therefore stored.

The data will be processed by IRIT in order to investigate :

* the correlation of the analyses with the context of nutrition and sports activity.
* the best recommendation on use (the best time)

Translated with www.DeepL.com/Translator (free version)

Hypothesis We assume that frequent occasional urinary analyses carried out independently by the subject allow us to identify changes in diet.

Final objective:

We would like to determine:

* a strong correlation between the different markers and the nutritional context
* the impact of physical activity on this correlation
* the most relevant moment of analysis (optimising correlation) in order to define recommendations for use

Protocol:

During the inclusion consultation, Professor Gamé will provide the subject's self-test, mobile application and user account. The correspondence table between the user account and the data identifying the subject will only be accessible and kept by Professor Gamé and his team. During this consultation, will be exposed :

* the context and objectives of the study
* the use of the self-test and its recommendations

Thus, no samples will be taken and therefore retained. The cartridges are single-use cartridges and will therefore be thrown away by the subject. The reader will be returned to the partner who developed it (Innopsys) at the end of the protocol.

The subject will have recommendations on the frequency of use which will not be binding and will not have any impact on his participation in the trial. These recommendations will be composed of 2 phases:

Phase 1: frequency of use: 3X/day for 1 month. Phase 2: Frequency of free use. This phase will make it possible to observe the level of acceptability of the technology.

The subject will provide information on his diet by sending a photo of his meals via the mobile application provided. This will then be analysed by algorithms (or operators if the accuracy of the algorithms is insufficient) to extract the type and quantity of food ingested.

Throughout the protocol, the subject will be able to send summary data of his or her sporting activities via the web application linked to the project. These data will be :

* The number of steps taken
* Average heart rate
* The duration of the effort
* The theoretical energy expended

The subject may request a consultation with Professor Gamé during the study in order to have a medical opinion on these results.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

chronic disease
A Study Of The Safety and Efficacy Of Viagra In Men With Erectile Dysfunction Who Do Not Self Identify.

To compare the efficacy and safety of Viagra (sildenafil citrate) vs. placebo for the treatment of men with ED and at least 1 prespecified risk factor who do not self identify as having ED.


Eligibility Criteria:
Inclusion Criteria:

* Men who do not identify as having ED with documented ED
* Men 30 years of age and older
* At least one prespecified risk factor for ED

Exclusion Criteria:

* Subjects currently prescribed, taking and/or likely to be treated with nitrates or nitric oxide donors in any form on either a regular or intermittent basis
* Subjects with a known history of retinitis pigmentosa.
Assessment of Dialysis Initiation by a Fuzzy Mathematics Equation

The purpose of this study is to evaluate the impact of the optimal and late initiation of dialysis on the mortality and quality of life in end-stage renal disease (ESRD) patients by the Dialysis Initiation based on Fuzzy mathematics Equation (DIFE), which is a novel equation for the assessment of timing of dialysis initiation established by Fuzzy mathematics.

The optimal time of dialysis initiation is still controversial. Estimated glomerular filtration rate (eGFR) which is now widely used as the assessment of timing of dialysis is lack of specificity. Some clinical factors such as heart failure, volume overload, malnutrition also determine the dialysis time. But these subjective judgements do not have a standard. So there is no quantitative assessment of timing of dialysis initiation. The research team developed a novel equation named DIFE (Dialysis Initiation based on Fuzzy mathematics Equation) with data from a retrospective multicenter cohort by fuzzy mathematical methods to combine these clinical factors and lab indexes. The DIFE was confirmed to be more accurate and convenient to use in clinical practice than eGFR only at the assessment of dialysis initiation time in the internal validation. For further validation of the DIFE, the team will conduct a multicenter randomized controlled trial. Patients who need hemodialysis will be randomized to optimal start dailysis group or late start dailysis group by the assessment of the DIFE. Based on the comparison of the two groups, this trial will provide evidence for the optimal timing of dialysis initiation in patients with end-stage renal disease by the DIFE.

Eligibility Criteria:
Inclusion Criteria:

* Have progressive chronic kidney disease with an eGFR less than 15 ml/min/1.73m2 and a DIFE between 30-35
* Expected to commence maintenance hemodialysis as their renal replacement treatment
* Agreeable to randomization

Exclusion Criteria:

* Acute kidney injury (AKI) or AKI on chronic kidney disease (CKD)
* With the primary disease of systemic lupus erythematosus (SLE) or systemic vasculitis
* Have received or planning to receive a kidney transplant or peritoneal dialysis during the study
* Has a recently diagnosed cancer that was likely to affect survival (except for the following cases: the cancer has been confirmed to be cured or relieved for over 5 years, have had the radical resection for the basal cell carcinoma or squamous carcinoma of skin or carcinoma in-situ of any part of the body )
* Hepatocirrhosis
* Positive test of Human Immunodeficiency Virus (HIV), the hepatitis B virus antigen (HBsAg) or anti-hepatitis C virus antibody (HCV Ab)
* Acute infection within 1 month
* Bad habit which is difficult to withdrawal such as alcohol abuse
* Poor compliance and could not be treated according to the protocol
* Being pregnant, nursing or having a plan for pregnancy
* Life expectancy less than 1 year
* The investigator confirm that should not enroll in the study with any other cases
Melatonin vs Gabapentin for Post Trauma Surgery

This project aims to compare the effect of preoperative administration of melatonin and gabapentin in reducing preoperative anxiety, stress markers and postoperative pain levels in trauma patients undergoing surgery. Gabapentin has analgesic as well as sedative properties. Melatonin, a hormone has been extensively used in intensive care units and has found to improve the sleep cycle and reduce pain. It is now being explored as a preoperative medication.


Eligibility Criteria:
Inclusion criteria: Patients will be recruited if they satisfy the following inclusion criteria:

* Age 18-65 years,
* ASA score I-II,
* Scheduled either for non-emergency surgery after trauma and
* Presumptive duration of operation not exceeding 3 hours.

Exclusion criteria: The following patients will be excluded from the study:

* Patients for emergency surgeries
* Surgeries taking place after 1pm (to account for diurnal variation in cortisol levels)
* Patients having altered mental state, history of psychiatric disorder, history of drug abuse or those on chronic pain medication
* Patients who have come for a repeat surgery and have already been included once in the study
The Effectiveness of Resistance Training on Glycemic Control for Patients With Type 2 Diabetes in Cardiac Rehabilitation

This study is designed to investigate the effect of a structured resistance training program on glycemic control, measured by hemoglobin A1c (glycated hemoglobin), in patients with type 2 diabetes (T2DM) who are enrolled in outpatient cardiac rehabilitation. The investigator will compare the experimental group receiving resistance training to a control group made of patients enrolled in outpatient cardiac rehabilitation and perform 3 aerobic exercise modalities during their sessions, which is the current standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis with T2DM and have been accepted for a standard outpatient cardiac rehabilitation program
* Cognitively able to comprehend the information presented in the program
* Cognitively able to give informed consent to participate in this study

Exclusion Criteria:

* Patients with orthopedic or neurological limitations that would prevent them from participating in the resistance training program or monitored exercise sessions.
A Study of Taspoglutide in Patients With Inadequately Controlled Diabetes Mellitus Type 2 and Cardiovascular Disease

This randomized, double-blind, placebo-controlled parallel arm study will assess efficacy and safety and the effects of taspoglutide on cardiovascular events in patients with inadequately controlled type 2 diabetes mellitus and established cardiovascular disease. Patients will be randomized to receive either taspoglutide subcutaneously (sc) 10mg weekly for 4 weeks followed by 20mg sc weekly, or weekly sc placebo, in addition to background anti-hyperglycemic medication and standard of care treatment for cardiovascular disease. Anticipated time on study treatment is up to 2 years. Target sample size is 2000 patients.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>18 years of age
* diabetes mellitus type 2
* HbA1c \>/=6.5% and \</=10% at screening
* BMI \>/=23kg/m2
* cardiovascular disease with onset \>/=1 month prior to screening

Exclusion Criteria:

* diagnosis or history of type 1 diabetes or secondary forms of diabetes
* acute metabolic diabetic complications within past 6 months
* severe hypoglycemia \</=1 month prior to screening
* clinically significant gastrointestinal disease
* history of chronic or acute pancreatitis
* current New York Heart Association (NYHA) class IV heart failure or post-transplantation cardiomyopathy
* severely impaired renal function
Prostate Cancer E-Health-Tutorial

In a participatory process involving urologists and former patients, the project team has developed an online information system ("tutorial") for patients with localized prostate cancer. In this field test, relevant outcomes are measured and the tutorial will be tested for its clinical applicability.

Prostate cancer is the most common cancer in men: In Switzerland, every year about 6,000 men are diagnosed with prostate cancer. Men with prostate cancer at an early stage are confronted with a difficult decision: they are faced with different treatment alternatives, each with its own advantages and disadvantages. That is why a comprehensive information delivery and processing is extremely important for patients to make an informed decision.

Therefore, an online platform has been developed in collaboration with urologists and former patients. This online platform is designed to cover the individual information needs of patients with early prostate cancer. Additionally, the software aims at facilitating cooperation between patients and doctors and at increasing the satisfaction of patients with their treatment decision.

In this study, the online platform will now to be tested in clinical practice, and data will be collected for the benefit of the platform: Can the online platform actually satisfy the indivudal information needs, facilitate the therapy decision and support the cooperation between doctors and patients?

Eligibility Criteria:
Medical Inclusion Criteria:

* tumor stage: clinical stage T1 or T2
* PSA level \<20 (PSA = Prostata-specific antigen)
* Gleason score \<8
* age ≤ 75 years
* Assumed life expectancy ≥ 10 years

Other inclusion criteria due to the study design and the type of intervention are the following:

* patients have to be diagnosed in one of the trial sites
* Internet-enabled device in the patient's household / basal user knowledge of this device
* signing of the consent form

Exclusion Criteria:

* Impaired judgment
* Insufficient ability to read and understand German
* Emotional problems
Supply With Micronutrients (Purine and Pyrimidine) in Infants: a Prospective and Observational Study

Concentrations of micronutrients (especially purine and pyrimidine) in cord blood, blood of mothers and infants and human milk is studied

Collection of:

1. cord plasma in preterm and term infants.
2. remnants of clinically indicated blood samples of mothers 24 hours before or after birth.
3. remnants of clinically indicated blood samples of preterm and term infants during neonatal care.
4. breast milk once a weak during neonatal care of the infant.

Determination concentrations of micronutrients by mass spectrometry.

Aim is to compare cord plasma concentrations with postnatal plasma concentrations and to measure concentrations in breast milk to determine the actual supply.

Update September 2020:

The results obtained according to the original protocol revealed a serious sample instability when using remnants of clinical blood samples. Remnants can not be used and therefore the protocol had to be changed. A new approval of the Ethics Committee was obtained and is available to the study team. The following changes for sample collection were implemented: an additional blood sample (2.7ml EDTA blood) is taken from the mothers after approval.The blood samples of premature and newborns (max. 3x 0.2 ml) are obtained when a clinically indicated blood sample is taken. In both cases the serum is frozen immediately within one hour after collection.

Due to these changes, the expected end of the study is postponed to 2021.

Eligibility Criteria:
Inclusion Criteria:

* 23+0-42+6 SSW

Exclusion Criteria:

* congenital malformation, genetic disorders
* metabolic disease of the infant
* missing agreement
Interventions For Neck Pain In Relation to Internet Usage

After the rapid increase in the use of the Internet in the world, it has brought some negativities.People with internet addiction describe all the time they spend without internet as worthless and they want to be on the internet with an increasing desire.

Under all this information, the exercise program and walking programs that are easily added to people's lives in the study; The effects on stress and sleep levels were investigated by reducing neck pain symptoms in people with internet addiction.

Eligibility Criteria:
Inclusion Criteria:

* 20 and 25 years old, have internet addiction
* have neck pain complaints for more than three months
* low category according to the International Physical Activity Index.

Exclusion Criteria:

* Participants who had mobility limitations and neurological problems -had spinal surgery, had a traffic accident in the last three months and were injured by whiplash injury mechanism- visual and hearing impairments,
* refused to participate in the study.
Expanded Access to Velmanase Alfa

Individual patient expanded access requests may be considered for patients who have no other treatment options.

Expanded access may provide access for treatment prior to approval by the local regulatory agency.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Progression of Untreated Pulmonary Ground Glass Opacity

In this study, about 2000 GGO patients will be included for a 5-year follow-up. The aim of this study is to elucidate the biological nature of pulmonary GGO lesion and provide evidence for GGO treatment.


Eligibility Criteria:
Inclusion Criteria:

* 35-80 years' old
* found pulmonary GGO with chest CT scan and CT follow-up after 3 months shows that the GGO remains
* Diameter of GGO \> 5mm and \< 3cm
* Solid component of GGO in pulmonary window \< 5mm
* signed informed consent form

Exclusion Criteria:

* receiving immunosuppressor or steriods
* receiving chemo- or radio- therapy
* can not receive regular follow-up
Telemedicine Notifications With Machine Learning for Postoperative Care

The ODIN-Report study will be a randomized controlled trial of the effect of providing machine learning risk forecasts to providers caring for patients immediately after surgery on serious complications. The complications studied will be ICU admission or death on wards, acute kidney injury, and hospital length of stay.

This will be a single center, randomized, controlled, pragmatic clinical trial. The investigators will screen surgical patients enrolled in TECTONICS (NCT03923699) and randomized to intraoperative contact. Near the end of the operation, the investigators will calculate the same machine learning risk forecasts of major complications as TECTONICS, and enroll patients if all of the following are true: (1) No ICU admission is intended (2) ML mortality risk forecast is in top 15% of historical PACU patients.

Patients will be randomized 1:1:1 to no contact, brief contact, and full contact. The postoperative provider (PACU physician, anesthesiologist, ward clinician) will be notified before arrival of the risk forecast in the contact groups, and in the full contact group an additional set of explanatory ML outputs will be provided. The intention-to-treat principle will be followed for all analyses.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in TECTONICS Study (ID 201903026, NCT03923699), in OR randomized to contact
* workweek hours
* preoperative assessment completed
* estimated risk of mortality in top 15% of historical PACU patients

Exclusion Criteria:

* Not enrolled in TECTONICS Study
* Operating room randomized to non-contact in TECTONICS
* Planned ICU admission
A Randomized Clinical Trial of Shenbai Granules in Reducing Recurrence of Colorectal Adenoma

This study evaluates Shenbai Granules in Prevention of Colorectal Adenomatous Polyp Recurrence After Colonoscopy.Half of participants will receive Shenbai Granules,while the other half will receive a placebo.

There is no internationally recognized standard treatment for the prevention of recurrence of colorectal adenomatous polyps.

Based on TCM,previous studies have found that Shenbai Granules can significantly reduce the recurrence and deterioration rate of colorectal adenomatous polyps,reduce the proliferation of tumor cells and promote apoptosis of tumor cells.

Eligibility Criteria:
Inclusion Criteria:

1. meet the colorectal adenomatous polyp diagnosis.
2. polypectomy under colonoscopy;Including snare polypectomy,endoscopic mucosal resection,endoscopic submucosal dissection.
3. aged 18-70.
4. sign informed consent.

Exclusion Criteria:

1. colonoscopy was reported, but no pathological findings were found.
2. patients with hereditary polyposis.
3. there is reliable evidence that the tumor has infiltrated into the intrinsic mucosal layer,or deep infiltration under the mucosa is suspected.
4. combined with colorectal malignancy or previous history of colorectal malignancy.
5. colonoscopy highly suggests inflammatory bowel disease.
6. pregnant and lactating women.
7. women who recently have a planning pregnant programme.
8. prone to bleeding and using anticoagulants.
9. patients with severe cardiovascular,pulmonary and cerebrovascular diseases and liver and kidney dysfunction (ALT and AST are two times higher than the upper limit of normal value in the laboratory of the center;Serum creatinine and urea nitrogen are 1.5 times higher than the upper limit of the normal value in the laboratory of the center.
10. unstable vital signs.
11. suspect or have a history of alcohol or drug abuse.
12. frequent changes in the working environment or other circumstances are likely to cause loss of interview.
13. drugs (aspirin, folic acid, vitamin D, calcium) with potential to treat colorectal adenomas have been used.
14. those who are participating in other clinical trials.
Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren in the Treatment of Subjects With Osteoarthritis of the Knee

To establish the therapeutic equivalence and safety of a generic Diclofenac Sodium Topical Gel, 1% with Voltaren® Gel 1% in subjects with osteoarthritis of the knee.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, ambulatory male or non-pregnant female subjects aged ≥ 35 years with a clinical diagnosis of OA of the knee.
* Had an X-ray of the target knee, taken no more than 1 year before baseline, showing evidence of OA with Kellgren-Lawrence grade 1-3 disease.
* After discontinuing all pain medications for at least 7 days, has at least moderate pain on movement for target knee
* If female and of child-bearing potential, agree to abstain from sexual intercourse or use a reliable method of contraception during the study
* Able to tolerate rescue medication with paracetamol/acetaminophen.

Exclusion Criteria:

* Pregnant or lactating or planning to become pregnant during the study period.
* X-ray showing evidence of OA with Kellgren-Lawrence grade 4 disease.
* History of OA pain in the contralateral knee requiring medication within 1 year prior to screening.
* After discontinuing all pain medications for at least 7 days, has a baseline score of ≥20 mm on a 0-100 mm Visual Analog Scale (VAS) for the contralateral knee immediately prior to randomization.
* History of secondary OA, rheumatoid arthritis, chronic inflammatory disease or fibromyalgia.
* History of asthma, hypertension, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function or liver disease.
* History of gastrointestinal bleeding or peptic ulcer disease.
* Use of warfarin or other anticoagulant therapy within 30 days of study randomization.
* Elevated transaminases at screening.
* Use of ACE inhibitors, cyclosporine, diuretics, lithium or methotrexate, within 30 days of study randomization.
* Concomitant use of corticosteroids or use within 30 days of study randomization.
* Concomitant acetylsalicylic acid therapy other than a stable low dose used for cardiac prophylaxis taken for at least 3 months prior to enrollment and maintained throughout the duration of the study.
* Known allergy to aspirin or nonsteroidal anti-inflammatory drug
* Any other acute or chronic illness that could compromise the integrity of study data or place the subject at risk by participating in the study.
* Receipt of any drug as part of a research study within 30 days prior to screening.
* Previous participation in this study.
* Any use between screening and baseline of a treatment or medication that may potentially confound study assessment that may potentially confound study assessment (e.g. use of topical analgesics or anti-inflammatory drugs).
* Recent history of major knee injury or surgery.
* Known history of positive HIV