cyrilzakka/clinical-trials huggingface dataset:
Improving the Diagnosis of Diarrhoea in Emergency Rooms

A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the diagnosis in less than two hours of diarrhoea caused by known pathogens, close to the reception of Emergency service. In this instance 30% of patients have no etiological diagnosis after the POC diarrhoea tests . This lab has discovered over 200 new species of bacteria in humans, including vector bacteria and opened the field of large Deoxyribonucleic Acid (DNA ) viruses. Also, the laboratory of emerging viruses discovered many Ribonucleic Acid (RNA) viruses transmitted by arthropods. Based on this collection of new pathogens described in POC laboratory, this study proposes to expand the etiological diagnosis strategy of diarrhoea after POC tests.


Eligibility Criteria:
Inclusion Criteria:

* Patient admitted at hospital for diarrhoea requiring, for the emergency physician, a microbiological examination with a "POC diarrhoea kit."
* Patient who has freely signed the informed written consent
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Pregnant woman, parturient or nursing
* Adult major under guardianship
* Patient deprived of liberty under court order
* Patient refusing or unable to sign the informed consent form.
Safety and Efficacy of BMMNCin Patients With Mental Retardation

Mental retardation is a condition diagnosed before age 18 that includes below-average general intellectual function, and a lack of the skills necessary for daily living. Mental retardation affects about 1 - 3% of the population. There are many causes of mental retardation, but find a specific reason in only 25% of cases.Bone marrow derived stem cells are used in this condition to prove its safety and efficacy .


Eligibility Criteria:
Inclusion Criteria:

* Age limit: 5 -50
* Primary diagnosis of mental retardation (IQ \< 70)
* willingness to undergo Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs) transplantation.
* To give an informed consent as well as sign the required Informed Consent Form (ICF)/video Consent for the study.
* willingness to regularly visit the hospital / clinic for follow up during the follow up period / on prior agreed time points as per the protocol.

Exclusion Criteria:

* Positive test results for HIV and AIDS complex ,HCV (hepatitis C virus ), HbsAg and Syphilis
* Advanced age that may produce deteriorating cognitive or motor functioning
* Multiple sensory or motor disabilities that will interfere with seeing the stimuli and responding to the computer
* Poor general health
A Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]BMS-986419 in Healthy Male Participants

The purpose of this study is to assess the pharmacokinetics (PK), metabolite profile, routes and extent of elimination, mass balance, as well as safety and tolerability of \[14C\]BMS-986419 in healthy male participants.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 18.0 and 33.0 kilograms/meter square (kg/m\^2), inclusive, at screening. Body mass index = weight (kg)/(height \[m\])2.
* Healthy male participants as determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \[for example, suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable) at screening and check-in (Day -2).

Exclusion Criteria:

* Any significant acute or chronic medical conditions.
* Any major surgery within 30 days of study intervention administration, such as gastrointestinal surgery (for example, cholecystectomy and any other gastrointestinal surgery) that could impact the absorption of study intervention (uncomplicated appendectomy and hernia repair are acceptable).
* Current or recent (within 3 months of study intervention administration) gastrointestinal disease that could impact the absorption of study treatment.

Note: Other protocol-defined inclusion/exclusion criteria apply.
Evaluation of Safety and Performance of the CytaCoat Lubricious Infection Prevention (LIP) Foley Catheter

The goal of this pilot safety and tolerability study is to determine whether the novel CytaCoat LIP (Lubricious Infection Prevention) Foley catheter is safe to use in patients during short term use.

The primary objective of this study is to determine the safety and tolerability for the medical device CytaCoat LIP Foley catheter in patients undergoing Transurethral Resection of the Bladder (TUR-B) surgery. Safety will be assessed by evaluation of adverse events.

The secondary objective is to assess the overall performance by evaluating if there were any Foley catheter handling problems experienced by the healthcare personnel with the use of the CytaCoat LIP Foley catheter.

Exploratory objectives are to assess bacterial culture of urine samples taken before and after catheterization and to assess pain, irritation and discomfort measured by asking patients about their experience using the catheter using a questionnaire.

Participants will be catheterized with either a CytaCoat Foley catheter or an uncoated silicone catheter, for a maximum of 24 hrs. After removal of the catheter, participants will be asked to assess if they experienced any pain, irritation and discomfort measured with the Numerical Rating Scale (NRS) (0-10). A similar assessment will be performed 7-10 days after removal of the catheter. In addition, the healthcare personnel will be asked to assess the functionality of the coated catheter with the NRS scale (0-10), using a questionnaire. Urine samples will be taken before and after catheterization and evaluated through quantification.


Eligibility Criteria:
Inclusion Criteria:

* Will be undergoing a TUR-B procedure.
* Able to give informed consent by signing and dating the written informed consent document acknowledging their desire to participate in the study.
* Adults, age 18 to 84 years.
* Require insertion of a size 12, 14, 16, 18 or 20 French Foley catheter after TUR-B surgery.
* Be able to understand and comply with the information given in the Patient Consent Form.

Exclusion Criteria:

* Vulnerable subjects such as children, pregnant or breastfeeding women, or potentially immune-compromised subjects.
* Unable to provide informed consent.
* Has a known bacteriuria or a current urinary tract infection.
* Has a known bloodstream infection or an infection that requires prolonged antibiotic therapy.
* Has an ongoing antibiotic therapy.
* Cannot accommodate a size 12, 14, 16, 18 or 20 Fr Foley catheter or requires a Thiemann tip Foley catheter.
* Previous enrolment in the present study.
* Simultaneous participation in another clinical study that may impact the primary endpoint.
* Severe non-compliance to protocol as judged by the PI.
Influence of Two Paraffin Wax Chewing Gums of Different Consistency on the Stimulated Saliva Flow Rate

The study examines two different chewing gums with regard to consistency and its influence on the result of sialometry

The examination (sialometry) is performed on healthy volunteers. The volunteers must chew on a paraffin gum for seven minutes. After each minute, the amount of secreted saliva is spat into a designated cup and evaluated. This test is performed with Aurosan chewing gum and later with GC Europe chewing gum.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers
* non-smoker
* no medication

Exclusion Criteria:

* physical or mental illnesses
* smokers
* regular medication intake
* pregnant women
* dementia or persons who are unable to judge or persons with guardianship
* minor test persons
Natural Killer Index From Hematopoietic Stem Cell Graft

Numerous studies about the potential role of NK alloreactive during a n hematopoietic stem cells graft are based on genotypical analyses of the KIR receptors and on genotypic incompatibilities between KIR and HLA for couple donor/recipient. There is still a lot of issues non resolved: Are KIR really expressed and how occur their expression during time when hematopoietic reconstitution? Is it depending on HLA of the recipient?If KIR are expressed, what are the mechanisms of alloreactivity of NK cells? Are NK able to lyse tumoral cells? Could alloreactive NK cells constitute a therapeutic tool able to induce tolerance and elimination of leukemia during hematopoietic stem cells grafts?


Eligibility Criteria:
Inclusion Criteria:

* Age superior to 1 year
* Patient that will be treated by an HSC graft
* Initial pathology of recipient: acute lymphoblastic leukemia, acute myeloblastic leukemia, chronic myeloid leukemia

Exclusion Criteria:

* Patient already included in a study with an exclusion period
* HIV + or HCV + serology during pre-graft analysis
* Patient already treated by an allograft of HSC
Mu Opioid Receptor 1 Expression and Activation Patterns in Colorectal Cancer

Observational case-control study in a retrospective cohort of patients with stage II or III colorectal cancer undergoing scheduled surgery.

Observational case-control study in a retrospective cohort of patients with stage II or III colorectal cancer undergoing scheduled surgery. Period January 2010-December 2014. Patients must have had at least 5 years of follow-up to define disease-free survival. From the cohort of patients previously studied in our center by immunohistochemistry, 31 we will select 10 cases with recurrence by random sampling and we will match 10 controls by leveling the propensity score (propensity score matching).

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age.
* Colorectal surgery scheduled between January 2010 - December 2014.
* Stage II or III colon or rectum neoplasm (T3 / T4 N + M0).

Exclusion Criteria:

* Neoplasia of colon or rectum in Stage I or Stage IV.
* Non-oncological colorectal surgery.
* Urgent surgery
Validation of User Needs of the Point Digit With Partial Hand Amputees

The objective of the device feasibility study will be to validate the user needs of the Point Digit system. This study will be a single group intervention model where one group of 5 partial hand amputees will be asked to perform several tasks. Successful completion of a task results in a fulfilled user need. Failure to complete a task results in an unfulfilled user need.


Eligibility Criteria:
Inclusion Criteria:

* Partial hand amputees with absence of index and/or middle fingers and presence of thumb. Additional finger loss is acceptable if all other criterion are met.
* Fluent in English
* Individuals aged 18 or greater

Exclusion Criteria:

* Significant cognitive deficits as determined upon clinical evaluation
* Significant neurological deficits as determined upon clinical evaluation
* Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation
* Uncontrolled pain or phantom pain impacting full participation in the study as determined upon occupational therapist evaluation
* Serious uncontrolled medical problems as judged by the project therapist.
Percutaneous Punch Biopsy for Diagnosis of Septic and Aseptic Prosthetic Joint Failure

The aim of the superiority study is to establish a reproducible, minimally invasive, cost-effective way of sample collection for microbiological and pathomorphological processing in a clinical setting with avoidance of anesthesia, multiple punctures, as well as potential deep contamination during irrigation.

The main aim of the study is to demonstrate the superiority of a punch biopsy over a joint tap to rule out or prove septic prosthesis failure and thus establish a new diagnostic method. The subsequently calculated sensitivities of the previous and the procedure are used as the main indicator. In addition, we would like to prove that the total cost of diagnosing a septic / aseptic prosthesis failure using the proposed method has socio-economic advantages over the previous algorithm.

One of the secondary objectives is the evaluation of the use of a punch biopsy for simultaneous a priori pathomorphological examination of periprosthetic soft tissue samples for the determination of wear particles. Furthermore, the study is intended to demonstrate a shortening of the time span between the first suspected diagnosis of septic prosthesis failure and its reliable exclusion / detection.

Eligibility Criteria:
Inclusion Criteria:

* Preceding implantation of a shoulder, hip or knee endoprosthesis
* Acute or chronic pain in the joint
* Periprosthetic fracture
* Instability of the endoprosthesis
* Indications of wear / insufficiency of the enclosed plastic spacers
* Indications of metal abrasion
* Primary misalignment of the implant

Exclusion Criteria:

* Confirmed periprosthetic infection
* Proven allergy to fast-acting local anesthetics
The Effects of Self-management Education Based on Theory of Planned Behavior on Patients With Type 2 Diabetes

The aims of the study are as follows:

* To improve self-management intention and behavior of patients with type 2 diabetes (T2 DM).
* To promote patients to make plans for their self-management and gradually integrate the self-management plan into their daily life.
* To improve resilience, well-being, fatigue and quality of life of patients with T2 DM

In order to achieve the aims, we have set the following objectives:

* To develop and apply self-management education program based on the extended theory of planned behavior.
* To evaluate the efficacy of the educational program:

  1. Self-management education program delivered face to face (intervention group); (b) standard usual care (comparison group).

This study employs a quasi-experimental study design with an intervention and comparison group and follow-up of 3 months; there will be two measuring points (baseline and 3 months after the intervention) , and 9 measures.

Eligibility Criteria:
Inclusion Criteria:

1. age ≥18 years
2. duration of type 2 diabetes ≥3 months
3. without any severe complication and impaired cognition.

Exclusion criteria are:

1. severe physical handicap or mental illness
2. presence of other serious disease such as cancer and stroke.
Efficacy of Two Vaginal Solutions in Preoperative Use

This study is necessary in order to provide proof the effectiveness of Chlorhexidine gluconate and its safety.

It is well known from the literature that the use of Povidone-iodone based solution for vaginal preparation before surgery is fraught with side effects and sensitivity, and often does not provide sufficient eradication of colonies of pathogens from the operation field.

It is also known that Chlorhexidine gluconate in low concentration provides a better result and does not cause side effects more than Povidone-iodone, but the chlorhexidine is still not approved for washing the mucous membranes. This study is necessary in order to provide proof of its effectiveness and safety.

Eligibility Criteria:
Inclusion Criteria:

1. Patients over the age of 18
2. Candidates for surgery (TOT- Trans Obturator Tape, cystoscopy, the introduction / removal of the stent the ureter, ureteroscopy), local or general anesthesia.

Exclusion Criteria:

1. A pregnant woman or post-partum.
2. A woman with known sensitivity to iodine, povidon or chlorhexidine.
3. Previous pelvic surgeries within three months from the surgery planned.
4. Patients taking antibiotics within one month from the surgery planned.
5. Immunological failure patients.
6. Patient unwilling to participate in the study.
7. Patients who require the appointment of a guardian condition
8. Women assigned to undergo a regular cystoscopy (no further action).
Penguin Cold Caps in the Prevention of Hair Loss in Breast Cancer Patients

The goal of this study is to estimate the efficacy of Penguin cold caps in preventing or reducing hair loss in patients receiving (neo)adjuvant chemotherapy (one of four common regimens) for early stage breast cancer.

This will be a phase II prospective, open label, non-randomized study conducted to determine the safety and efficacy of Penguin TM cold cap system in preventing or reducing chemotherapy-induced alopecia in patients with early stage breast cancer undergoing chemotherapy.

Eligible subjects will be enrolled to one of 4 study arms (Table 5) determined by type of chemotherapy. Subjects will have early stage breast cancer of any receptor subtype, for which standard of care includes chemotherapy. Eligible subjects will be enrolled at Providence Portland Medical Center (PPMC) and Providence St. Vincent Medical Center (PSVMC).

The PenguinTM cold cap therapy will be administered to all enrolled subjects according to the dosing schedule specified by the study arms. PenguinTM cold caps is a portable scalp cooling system which uses gel-filled cold caps that are cooled on dry ice and exchanged every 30 minutes in order to maintain optimum temperature. Its unique crylon gel formula is specifically created to maintain cold temperatures for much longer periods of time than other conventional cooling gels and foams. No scalp preparation is required before use.

Eligibility Criteria:
Inclusion Criteria:

* At least ≥ 18 years of age
* Diagnosis of stage I-III breast cancer for whom neoadjuvant or adjuvant cytotoxic chemotherapy (ACT/HP, TCH/P, TC, or T/H) is planned.
* Willing and able to provide informed consent.
* Availability of caretaker(s) to accompany participant and facilitate cold-cap placement/exchanges using the recommended technique.
* Women of childbearing potential must use acceptable measures to avoid becoming pregnant during study period and for 30 days after last dose of chemotherapy.

Exclusion Criteria:

* Pre-existing alopecia (Dean's scale ≥ 1)
* Another malignancy that required active treatment with systemic chemotherapy within 2 years of study recruitment.
* Prior radiotherapy treatment involving head.
* Pre-existing chronic severe headaches or migraines.
* Skin conditions that in the opinion of PI would be at risk of worsening with study.
* Cold sensitivity or cold agglutinin disease
* Cryoglobulinemia
* Cryofibrogenemia
* History of current evidence of any condition, therapy or abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, such that trial participation is not in the best interest of the subject.
A Study on Traditional Chinese Medicine (TCM) Comprehensive Protocol of Prevention and Control in Diabetic Retinopathy

1. Title: A Study on TCM comprehensive protocol of Prevention and Control in Diabetic Retinopathy.
2. Objectives of study: To evaluate the Intervention effect of integrate control protocol on reducing the incidence rate of proliferative diabetic retinopathy, PRP and MVL. Then produce a high performance, optimize, convenient, applicable and demonstrated protocol of integrate control with Intervention of TCM and west medicine.
3. Study Type: Interventional
4. Study Design: Multi-center, Randomized, Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Positive controlled clinical study.
5. Sample size: 480 subjects , divided into test and control groups equally.
6. Primary endpoint: incidence rate of proliferative diabetic retinopathy, panretinal photocoagulation

1. Primary outcome:

   * proliferative diabetic retinopathy
   * panretinal photocoagulation
2. Secondary outcome:

   * Vision, Funduscopy, Fundus photograph
   * Fundus fluorescein angiography
   * Visual Electrophysiology:FERG、OPs、PVEP.
   * Optical coherence tomography.
   * Symptoms scores of TCM.
   * The M0S short-form-36 heaIth survey(SF-36).
   * Visual Function Questionnaire-25(VFQ-25).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with diabetes mellitus.
* Diagnosed with non-proliferative diabetic retinopathy, including moderate and severe diabetic retinopathy
* and corrected VA≥45 letters(ETDRS), equivalent the decimal value of 0.16(20/125).
* Diagnosed with the syndrome and signs of TCM.
* HbA1C≤8.0%.
* Ages ranged from 35 to 75 years.
* Joined in the test voluntarily and signed the Informed consent by GCP regulation.

Exclusion Criteria:

* Complicating severe vitreous hemorrhage, or requiring laser and vitrectomy treatment.
* The patients who have been received the therapy of Retina laser photocoagulation.
* The patients whose dioptric media is so turbid that hard to evaluate the fundus picture.
* DMKA or other acute metabolic disturbance, or complicating severe acute infection within a month.
* Combined with other severe Diabetic complication.
* Having any allergic reaction to some drugs, food and pollen etc. or hypersensitiveness
* Pregnant or breast feeding.
* combined with primarily severe diseases such as cardiovascular, hepatic，renal illness ,hemopoietic system disease, and psychosis.
* Combined with glaucoma, uveitis, ocular neuropathy and severe cataract etc.
* Participated in other clinical trial within 3 month.
Exercise Training and Knee Joint Proprioception in Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a chronic disorder that affects 0.5% to 1% of adults and is the result of an autoimmune attack against joint tissues. In recent years, advances in anti-rheumatoid drugs and treatment strategies have improved the health status of patients with RA. However, many patients do not achieve disease remission and experience progressive functional impairment. According to 2003 data from the National Health Interview Survey in the United States, by 2030, approximately 25% of adults aged 18 years and older are expected to have doctor-diagnosed arthritis, and 9.3% of adults are expected to have arthritis-related activity limitations.

In order for patients with RA to perform activities of daily living, it is very important for them to maintain their balance, i.e., their sense of proprioception. It is known that knee proprioception is decreased in RA. In addition, the presence of pain, decreased muscle strength, and functionality in patients with RA lead many of them to adopt a sedentary lifestyle.

The main aim of this study was to evaluate the effects of exercise training on knee joint proprioception in individuals with RA. In addition, it also aims to examine how exercise training improves pain, functionality, performance, fear of falling, biopsychosocial status, and quality of life. The importance of this research is that it provides more scientific data for improving knee joint proprioception in individuals with RA and guides clinical practice. It is also expected to contribute to the development of a comprehensive approach to improving the quality of life of patients by demonstrating not only the physical but also the psychological and functional effects of exercise training.


Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with RA
* Being able to walk
* Being between the ages of 40-65.
* Accepting to participate in the study and approving the informed consent form.
* Being literate and able to use technological devices.

Exclusion Criteria:

* Having acute inflammatory pathology in the knee joint.
* Knee arthroplasty surgery.
* Intra-articular or systemic corticosteroid use in the last 3 months.
* Having participated in an FTR program in the last 3 months.
* Advanced musculoskeletal, cardiac or peripheral vascular disease.
* Significant system or organ failure.
* Having a disease that will affect cognitive functions such as Alzheimer's disease or dementia
Montreal Toulouse Test With Eye Tracking in Intensive Care Unit to Evaluate Comprehension

Assessment of the level of oral comprehension of the intensive care patient is essential to improve their care because they have often troubles like delirium.

Assessment of the level of oral comprehension of the intensive care patient is essential to improve their care because they have often troubles like delirium.

Eligibility Criteria:
Inclusion Criteria:

* French speaker, RASS (Richmond Agitation-sedation scale) between -1 and +1, agree for participation

Exclusion Criteria:

* neurovisual disorders