cyrilzakka/clinical-trials huggingface dataset:
A Phase II Open Label Study of BMS-582664 in Locally Advanced or Metastatic Hepatocellular Cancer

The purpose of this clinical research study is to learn if BMS-582664 can shrink or slow the growth of advanced liver cancer. The safety of this treatment will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hepatocellular carcinoma (HCC) ≥ 2cm based on:
* Biopsy OR
* Radiological evidence of HCC by contrast-enhanced CT scan or contrast-enhanced AND
* Blood test positive for Hepatitis B or C AND
* Alpha fetoprotein above \> 400 mg/L
* Not appropriate for curative surgery
* Screening Blood Pressure \<150/100 mmHg, Left Ventricular Ejection Fraction (LVEF) \>50%

Exclusion Criteria:

* Heart Attack within 12 months, uncontrolled chest pain within 6 months
* Ascites resistant to diuretic medication therapy
* Portal-systemic encephalopathy
* Portal hypertension with bleeding esophageal or gastric varices within the past 2 months
* Deficiency of sodium in the blood with sodium \< 125 mEq/L
* Subjects with serious non-healing wounds, ulcers or bone fractures
Impact of the Therapeutic Education Program "living with a Chronic Inflammatory Disease Under Biotherapy" on Patient Compliance and Quality of Life

Patient therapeutic education programs have been shown to be effective in many specialties, allowing "Improving biological and psychological parameters, allowing patients to improve their health knowledge, therapeutic adherence and sense of personal effectiveness." Several studies have shown that patient knowledge, adherence and satisfaction are better after attending a therapeutic education program.

This multidisciplinary program is presented and offered to all patients with chronic disease treated by subcutaneous biotherapy, followed by dermatologists, rheumatologists and gastroenterologists of the Lorient hospital.

The study aims to demonstrate the benefit of the Patient Therapeutic Education program at GHBS Lorient "living with a chronic inflammatory disease under biotherapy" on treatment adherence, as well as the positive impact on quality of life.

All patients followed up as part of their chronic disease and treated with subcutaneous biotherapy in the dermatology, rheumatology, hepatotherapygastroenterology, will be offered participation in the therapeutic education program by GHBS specialists. Whether they agree to participate or not, doctors will offer them participation in the IMPEBIO study.

Patients treated with subcutaneous biotherapy who do not wish to participate in the program will be included in the control group.

Patients treated with subcutaneous biotherapy who wish to participate in this program will be included in the intervention group. The therapeutic education program will begin within 3 months of inclusion.

If the patient does not object, the Morisky scale and the SF 12 questionnaire will be given to him. It may be assisted with filling if necessary by a clinical researcher.

Patients will first complete the Morisky test, and the quality of life questionnaire SF 12 at inclusion in the IMPEBIO study (J0), then to M6 (6 months), M12 (12 months) and M18 (18 months).

These questionnaires will then be retrieved, anonymized and sent to the investigation department. The analysis of questionnaires will not lead to changes in patient management.

Estimated time to complete the questionnaires is 10 minutes.

Eligibility Criteria:
Inclusion Criteria:

* All major patients followed up on GHBS for chronic inflammatory disease treated with S/C biotherapy.
* Patients not opposed to their participation in the research.
* Less than 3 months between inclusion and start of Therapeutic Education Program.

Exclusion Criteria:

* Subcutaneous injection by another person.
* Patients with cognitive impairment.
* Persons of legal age who are the subject of a legal protection (safeguarding of justice, curatorship, guardianship), persons deprived of liberty.
* Pregnant women.
* Persons not covered by social security.
IV Acetaminophen and Post-Tonsillectomy Pain

This study is a randomized prospective study to compare the post-operative analgesic efficacy of intravenous acetaminophen 15 mg/kg to an equal volume of 0.9% normal saline when all other analgesic interventions have been standardized for all patients enrolled.


Eligibility Criteria:
Inclusion Criteria:

1. The subject is age 3 to 10 years (inclusive)
2. The subject weighs more than 10.0 kg (inclusive of the tenth kilogram)
3. The subject is scheduled for the following: Elective tonsillectomy or tonsillectomy with adenoidectomy scheduled on an outpatient basis, with acceptable inclusion of patients also having PETs and/or EUA of ear
4. The subject is ASA patient classification I-II
5. The subject's legally authorized representative has given written informed consent to participate in the study and when appropriate, the subject has given assent or consent to participate.

Exclusion Criteria:

1. Additional surgical procedures are being performed concurrently;
2. The subject is ASA classification \> II;
3. The subject has pre-existing allergy or known hypersensitivity to acetaminophen;
4. The subject receives midazolam as a premedication;
5. The subject has a history of chronic malnutrition;
6. The subject has any other condition, which in the opinion of the principal investigator, would not be suitable for participation in the study
A Novel Skin Barrier Protectant for Acute Radiodermatitis

Acute radiodermatitis (ARD) is a distressing and painful skin reaction that occurs in 95% of the patients undergoing radiotherapy (RT). To date, there is still no general approved guideline for the prevention and management of acute radiodermatitis. The 3M™ Cavilon™ Advanced Skin Protectant is a novel skin barrier protectant that acts as a physical barrier against abrasion, moisture, and irritants. Moreover, it enables an environment for wound healing. The aim of this study is to evaluate the effectiveness of 3M™ Cavilon™ Advanced Skin Protectant in the prevention and management of ARD in patients with head and neck cancer.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of head and neck squamous cell carcinomas (HNSCC) starting in the lip, salivary gland, oral cavity (mouth), nasal cavity (inside the nose), paranasal sinuses, pharynx, or larynx.
* Scheduled for bilateral neck radiotherapy (\>60 Gy) with or without concomitant chemotherapy either as primary or as post-operative treatment to the head and neck region
* Age ≥ 18 years
* Able to comply to the study protocol
* Able to sign written informed consent
* Signed written informed consent

Exclusion Criteria:

* Previous irradiation to the head and/or neck region
* Metastatic disease
* Patients with pre-existing skin rash, ulceration or open wound in the treatment area
* Patients with known allergic and other systemic skin diseases even when not directly affecting irradiated fields
* Substance abuse patients or patients with medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator
* Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator
* Patients using high doses of non-steroidal anti-inflammatory drugs
* Patients allergic to the ingredients of the 3M™ Cavilon™ Advanced Skin Protectant
AS-OCT Guided Treatment of Diffuse CSCC

A prospective study was performed on 8 eyes of 8 patients who underwent amniotic membrane graft after diffuse conjunctival squamous cell neoplasia excision followed by topical mitomycin C 0.04% eye drop between March 2014 and January 2018.

Surgical excision of the conjunctival tumour . A superficial corneal scraping was performed for corneal lesion then double freeze-thaw cryotherapy was applied to limbal edge and conjunctival margins.The amniotic membrane graft was secure and attached to the sclera and conjunctiva using ﬁbrin glue.Topical mitomycin C 0.04%eye drop was prescribed 4 times daily per treatment cycle (1 cycle=1 week on 1 week off).

Eligibility Criteria:
Inclusion Criteria:

* diffuse Ocular Surface Squamous Neoplasia

Exclusion Criteria:

* localized OSSN (less than ﬁve clock hours in limbal extent)
Effects of Vitamin D-Enriched Mushrooms on Vitamin D Status and Immune Function and Inflammatory Status in Adults

We propose to assess the effects of including vitamin D-enriched mushrooms as part of participants' usual eating pattern primarily on 25(OH) vitamin D2 status and secondarily on immune function and inflammatory status.

We hypothesize that consuming vitamin D-enriched mushrooms daily for 12 weeks will prevent decreases in serum 25-hydroxy-vitamin D2 concentrations. Secondarily, we hypothesize consuming vitamin D-enriched mushrooms daily for 12 weeks will improve clinical indicators of inflammatory status and alter/enhance immune status and immune cell function. This short-term randomized, controlled trial will provide important data to inform the plausibility, focus, and design of longer-term intervention trials, consistent with The Mushroom Council's research agenda regarding health-promoting effects of vitamin D-enriched mushrooms.

Eligibility Criteria:
Inclusion Criteria:

* BMI: 25.0-34.9 kg/m\^2
* Total cholesterol \<240 mg/dL
* low density lipoprotein cholesterol \< 160 mg/dL
* triglycerides \<300 mg/dL
* fasting glucose \< 110 mg/dL
* systolic/diastolic blood pressure \< 140/90 mmHg
* body weight stable for 3 months prior (+- 3 kg)
* stable physical activity regiment 3 months prior
* medication use stable for 6 months prior
* non-smoking
* non-diabetic
* not acutely ill
* females not pregnant or lactating
* willing to refrain from taking vitamin D supplements or any supplements containing vitamin D
* No history of bariatric surgery
* Not extremely or severely depressed (Beck's Depression Inventory Score \<= 30)
* Agree not to donate blood for at least one month prior to, during, and for one month after the study
* Agree not to travel to sunny locations during the study period
* Agree to forgo any tanning bed or other tanning procedures during the study
* Willing and able to consume mushrooms and travel to testing facilities

Exclusion Criteria:

* Age \<30 or \>70
* BMI \<25 or \>35kg/m2
* Total cholesterol \>240 mg/dL, low-density lipoprotein cholesterol \>160 mg/dL, triglycerides \>300mg/dL, fasting glucose \>110 mg/dL
* Systolic/diastolic blood pressure \>140/90 mm Hg
* Body weight changes in previous 3 months (±3 kg)
* Changes in physical activity regimen in the previous 3 months
* Medication changes in the previous 6 months
* Extremely or severely depressed (Beck's Depression Inventory Score \>30)
* Unwilling to refrain from taking vitamin D supplements or any supplements containing vitamin D
* Regiment of megadosing vitamin D
* Unwilling to not to travel to sunny locations during the study period
* Unwilling to forgo any tanning bed or other tanning procedures during the study
* History of bariatric surgery
* Consuming a restricted diet (such as keto, gluten free, high protein, low carb, etc.)
* Smoking
* Diabetic
* Acute illness
* Females pregnant or lactating
* Unwilling to not to donate blood for at least one month prior to, during, and for one month after the study
* Allergic to mushrooms or bread
A Study of AI in Cardiac Transplant in Echocardiographic Analysis (ORACLE)

The purpose of this research is to detect episodes of rejection versus non-rejection after cardiac transplant and the diagnostic accuracy of an Artificial Intelligence (AI) algorithm using the data from an ECG (electrocardiogram) and Cardiac Ultrasound (Echocardiogram and/or point of care ultrasound).


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing post-cardiac transplant endomyocardial biopsy, and the ability to provide informed consent and a consent for the study.

Exclusion Criteria:

* Refusal of study participation
Thrombin in Cardiac Surgery

Coagulopathy, bleeding, and transfusion are common in cardiac surgical patients. Our collaborator has developed a novel point of care device that can be used to assess thrombin generation in real-time in cardiac surgical patients. The investigators will measure thrombin generation using our novel device and compare it to standard methods, while examining the association of thrombin parameters with bleeding and other clinical outcomes.

This is a prospective observational cohort study of 200 cardiac surgical patients. Thrombin generation via our novel point of care thrombin generation assay as well as calibrated automated thrombography (CAT) will be measured at three time points: (1) before surgery; (2) post-CPB after heparin reversal with protamine; (3) at the time of chest closure or 60 minutes after heparin reversal with protamine. Clinicians will remain blinded to the measures. Recruitment will continue until the investigators enroll 50 patients with significant impaired thrombin generation capacity (\>50% drop from baseline) and 50 patients who receive hemostatic therapies. Patients will be followed for 7 days postoperatively to assess individual products transfused.

Eligibility Criteria:
Inclusion Criteria:

-All adult patients (\> 18 years of age) undergoing cardiac surgery at Toronto General Hospital will be offered participation.

Exclusion Criteria:

-Patients who are unable to consent to the study or who refuse participation will be excluded.
Impact of Bread Diet on Intestinal Dysbiosis and Irritable Bowel Syndrome Symptoms in Quiescent Ulcerative Colitis

The present study aimed to compare the in vivo prebiotic properties of bread produced by traditional breadmaking techniques with that made using a modern breadmaking method on Irritable Bowel Syndrome-like symptoms in patients with quiescent Ulcerative Colitis. The expected outcome of the differential effects was a change in the faecal microbiome composition, which may indicate changes in the mucosa-associated microbiota.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with ulcerative colitis according to established clinical and histological criteria as common clinical practice
* Remission of ulcerative colitis defined as a total Mayo score ≤2 and faecal calprotectin values under 250 ng/g
* Subjects aged over 18 years
* Moderate-to-severe IBS-like symptomatology defined by Rome IV criteria and IBS Symptom Severity Score (IBS-SSS) \> 175.

Exclusion Criteria:

* Presence of flare-up of UC
* Coeliac disease, colectomy, or intestinal resection
* Antibiotic intake, prebiotic or probiotic treatment within 3 months before the study
* Any malignancy, pregnancy, or breastfeeding
* Intake of medication potentially influencing gastrointestinal function
* Disability to give informed consent
Treatment of Gingival Recession Defects Using Platelet-Rich Fibrin With an Allogenic Dermal Matrix

The study aims to test the non-inferiority of an Allogenic Dermal Matrix with Platelet-Rich Fibrin for treatment of gingival recessions in comparison to the Connective Tissue Graft.

Currently the Connective Tissue Graft (CTG) is referred to as the gold standard in terms of the grafting material for the treatment of gingival recession defects. This study test the non-inferiority of the Allogenic Dermal Matrix (ADM) with Platelet-Rich Fibrin (PRF) to that of the CTG, in terms of the amount of root coverage obtained after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Periodontally and systemically healthy adults
* Full-mouth plaque score and full-mouth bleeding score ≤ 20%
* Presence of at least one 3 mm or deeper gingival recession, with at least 1.5 mm of Keratinized tissue, and 1 mm of gingival thickness) requiring surgical intervention for root coverage
* No interproximal attachment/bone loss
* No prior experience of root coverage procedures within the last 1 year
* The patient must be able to perform good oral hygiene

Exclusion Criteria:

* Contraindications for undergoing periodontal surgery
* Teeth with more than Grade II mobility, or furcation involvement of Class III
* Patients pregnant or attempting to get pregnant (self-reported), or nursing women
* Untreated/active periodontitis, or other untreated acute infections at the surgical site
* Untreated malignancies at the surgical site
* Persistence of uncorrected gingival trauma from traumatic toothbrushing
* Presence of severe tooth malposition, rotation or clinically significant super-eruption
* Self-reported current smoking more than 10 cigarettes/day or pipe or cigar smoking, or active tobacco chewing, or chronic vaping
* Patients with any known history of blood disorders or complications such as abnormal concentration of thrombin and factor XIII in plasma, or hemophilia
* Patients with significant co-morbidities, such as obesity, uncontrolled diabetes, immunosuppression, severe endocrine-induced bone diseases, signs of malnourishment, those receiving immunosuppressive therapy, poor tissue oxygenation or perfusion, and pre- or post-operative radiation
* Patients with known sensitivity to Polysorbate 20, Cefoxitin, Lincomycin, polymyxin B, Vancomycin
Ibuprofen Versus Acetaminophen vs Their Combination in the Relief of Musculoskeletal Pain in the Emergency Setting

The purpose of this study is to determine whether the combination of ibuprofen and acetaminophen, is more effective than either single agent alone in treating pain from acute musculoskeletal injuries in the emergency department.

The purpose of this study is to determine whether the combination of ibuprofen and acetaminophen, is more effective than either single agent alone in treating pain from acute musculoskeletal injuries in the emergency department. We hypothesize that the combination will be more effective than either agent alone in patients presenting to the emergency department with acute pain from musculoskeletal injuries such as sprain, and bruises. While each agent alone is effective to some degree, many patients do not find complete relief with them and often narcotic agents (with all of their potential side effects) are added. In this study patients experiencing any pain will be randomly given either ibuprofen OR acetaminophen OR their combination and their degree of pain severity will be measured every 15 minutes up to one hour. At the end of this 1 hour patients still experiencing pain and requiring additional pain relief will receive additional analgesics at the discretion of their treating physician. We will not only measure how much the pain severity was reduced but also the percentage of patients that require some form of additional or "rescue" medication.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who presented to the emergency department with pain (a verbal numeric pain score greater than 0 on a scale of 0 to 10 from none to greatest) secondary to an acute musculoskeletal injury of less than 24 hours of duration when one of the study investigators was present were eligible for enrollment

Exclusion Criteria:

* Patients who had taken an opioid containing analgesic as well as those with a prior history of allergy or contraindications to ibuprofen or acetaminophen.
Fasting Durations Before Bronchoscopy And The Discomfort Levels Of Patients

The goal of this clinical trial is to learn if patients feel more comfortable while being placed on contemporary fasting principle than on conventional fasting time during flexible bronchoscopy. The main questions it aims to answer are:

To compare the thirty levels between patients with conventional fasting time (≥ 8 hours) and those with contemporary fasting principle (clear fluids for up to 2 hours before anesthesia) during flexible bronchoscopy To compare the levels of mucosal dryness between two groups of patients during flexible bronchoscopy To compare the levels of hunger between two groups of patients during flexible bronchoscopy To compare the levels of tiredness between two groups of patients during flexible bronchoscopy To compare the levels of fatigue between two groups of patients during flexible bronchoscopy To compare the levels of nausea/vomiting between two groups of patients during flexible bronchoscopy

Participants will:

Being placed on fasting either using conventional fasting time (≥ 8 hours) or with contemporary fasting principle (clear fluids for up to 2 hours before anesthesia) Being asked to respond to questions regarding thirsty, mucosal dryness, hunger, tiredness, fatigue, and nausea/vomiting in a visual analogue scale of 0 to 10


Eligibility Criteria:
Inclusion Criteria:

* planned flexible bronchoscopy

Exclusion Criteria:

* tracheostomy or intubated
* known to be pregnant
* significant functional or structural abnormalities of the gastrointestinal tract
* oral intake prohibited and infeasible
Study of Stool Patterns to Collect a Panel of Stool Images for the Development of a Software

Collection of a panel of stool images from healthy infants/toddlers for the development of a software

To collect at least 200 images per Brussels Infant and Toddler Stool Scale (BITSS) score and at least 200 images of empty (no stool) disposable diapers from healthy infants/toddlers aged 0-24 months for the development of a software

Eligibility Criteria:
Inclusion Criteria:

1. Healthy infants/toddlers (0-24 months of age at time of enrollment)
2. Informed consent from mother ≥21 years of age
3. In-home access to reliable internet connections; a mobile device suitable for electronic communication; and a device suitable for capturing and transmitting high-quality electronic images as per the PI's discretion
4. Infant/toddler consumes standard, age-appropriate food (breast milk; formula; commercial/homemade baby, table or finger food)
5. Based on the number of stools already acquired per relevant strata at time of enrollment, infant/toddler may or may not be required to regularly produce stools scored as a Score 1, 2, 6 or 7

Exclusion Criteria:

Mothers of Infants/Toddlers:

1. The use of cloth diapers (mothers must commit to using disposable diapers for the duration of the study)
2. Known to have a significant condition (including during pregnancy) that might interfere with the study compliance, as per PI's clinical judgment
3. Deemed likely to be non-compliant with the study protocol, as per PI's clinical judgment
A Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Investigation to Evaluate the Performance and Safety of YVOIRE® Classic Plus Versus Comparator for Temporary Correction of Nasolabial Folds

A Study to Evaluate the Performance and Safety of YVOIRE Classic plus on NLF.

This is a Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Study to Evaluate the Performance and Safety of YVOIRE Classic plus Versus Comparator for Temporary Correction of Nasolabial Folds.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 21 years or above age.
* 2 or 3 of the 5-point (0-4) NLFRS (Nasolabial Fold Rating Scale).
* Agree to use proper contraception as guided in the protocol.
* Signed for Informed Consent.

Exclusion Criteria:

* have received permanent facial implants anywhere in the face or neck or planning during the investigation.
* have undergone facial plastic surgery of the lower face and nasolabial region within 12 weeks
* have undergone semi-permanent filler in lower face
* have undergone temporary dermal filler treatment in the lower two-thirds of face within 12 months
* Have undergone facial tissue augmentation or facial treatment with fat or botulinum injections in the lower two-thirds of face
* Have undergone mesotherapy or cosmetic procedures in face or neck within 6 months
* have used any over-the-counter anti-wrinkle products or prescription anti-wrinkle medicines for the nasolabial folds within 28 days