cyrilzakka/clinical-trials huggingface dataset:
Rosuvastatin to Lower Circulating Tissue Factor Bearing Microparticles in Metastatic Breast Cancer

Research studies have shown a strong association between cancer and blood clots in the veins (also known as deep vein thrombosis). These blood clots can flow to the lungs (pulmonary embolism) which in severe cases may be life threatening. Studies have demonstrated that increases in microparticles may contribute to the development of deep vein thrombosis in cancer patients. The purpose of this research study is to see if rosuvastatin lowers the number of tissue factor bearing microparticles in the blood (TFMP). TFMP are small particles that are generated from different types of blood cells in the body. In people who have cancer, TFMP are thought to be generated from cancer cells and may represent a risk factor for deep vein thrombosis.

* Since no one knows which of the study options are best, participants will be "randomized" into the following study groups: Group 1 (regular dose of rosuvastatin) or Group 2 (higher dose of rosuvastatin).
* Participants will take 1 pill of rosuvastatin every day for 4 weeks. Each 4 week period is called a cycle.
* Participants will have a physical exam at baseline, on day 1 of starting rosuvastatin, and 2 month visits. Laboratory tests will be taken at baseline, on day 1 of starting rosuvastatin, 6 weeks and 2 months.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic adenocarcinoma of the breast (Stage IV)
* Actively receiving endocrine therapy for at least 6 weeks (with or without HER2 therapy)
* Minimum age 18 years
* ECOG Performance status of 0, 1 or 2
* Normal organ and marrow function as defined in the protocol

Exclusion Criteria:

* Participants may not be receiving any other study agents
* Actively receiving chemotherapy (exclusive of hormonal or HER2 therapy ) within last 5 weeks
* Any statin therapy within the last 3 weeks
* Asian decent (including Filipino, Chinese, Japanese, Korean, Vietnamese or Asian-Indian origin)
* Concomitant use of the following drugs: cyclosporine, fibrates, niacin, gemfibrozil, ketaconazole, spironolactone, cimetidine, warfarin, erythromycin, or protease inhibitors
* Conditions predisposing to renal failure secondary to rhabdomyolysis
* Recent history of heavy alcohol use as judged by the treating physician
* Known to be pregnant (testing not required) or nursing
* History of rhabdomyolysis on statin therapy
* Known history of Hepatitis C or active hepatitis B infection (baseline testing not required)
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, hepatitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Association of Transcutaneous Electrical Nerve Stimulation and Hypnosis

At Saint-Antoine's hospital, in CETD a multidisciplinary team takes care of patients with chronic pain. Free-drug techniques are available to reduce their consumption of analgesics. This study is to assess the relief obtained by the simultaneous combination of these two techniques: transcutaneous electrical nerve stimulation and hypnosis.

In the pain management centers, patients with chronic pain are supported by a multidisciplinary team. To optimize and reduce drug intake of analgesics, additional techniques (hypnosis, relaxation, cognitive behavioral therapy) and non-drug practices (transcutaneous electrical nerve stimulation) are offered to patients.

These techniques are most frequently performed by nurses and are used either separately or successively. The time interval during what the patient could expect pain relief is not known.

The hypothesis of the study is that simultaneous practice of two complementary therapies (transcutaneous electrical nerve stimulation (TENS) + hypnosis) decreases the intensity of pain in patients with chronic no cancer pain, nociceptive and/or neuropathic pain compared to practice of only one complementary therapy (TENS).

This study is an open randomized trial, comparative in two parallel groups (TENS versus TENS and hypnosis).

Trial design will be explained by the pain management center doctor. Inclusion and randomization performed by the nurse: group with TENS/group with TENS and hypnosis.

The patients will be followed up 8 times between day 0 and day180. Patients benefit from eight visits from day 0th to day 180th. Evaluations are EVA at each visit, SF36 questionnaires and score PGIC at one month, three and six months after the beginning of the strategy.

Eligibility Criteria:
Inclusion Criteria:

* Patients from 18 to 80 years suffering from chronic no cancer pain either nociceptive or neuropathic.
* The treated skin must not be wounded
* The patients must be able to comply with the requirement of the trial; they also need to express no objection to participate to this trial.
* Patient with social security

Exclusion Criteria:

* Patients with fibromyalgia, or having relaxation therapy sessions, acupuncture, cognitive and behavioral therapies
* Patients with cognitive disorders, an unaided hearing loss, a major hearing impairment, carrying a pace maker, having an allodynia or a complete anesthesia of the painful territory, a large spreader painful territory
* Sessions TENS practiced for analgesic by a professional within 3 years prior to inclusion, for the same pain (same features, same location)
* Renting at home a TENS device within 3 years prior to inclusion for analgesic
* Prior therapeutic care by hypnosis
* pregnant woman or having a desire of pregnancy
Regenerative Medicine Approach to Nasal Reconstruction

The purpose of this study is to gather information on the safety and effectiveness and compare nasal reconstruction standard planning versus 3D preoperative scanning/printing/planning.

Patients with nasal defects from cancer, trauma, prior surgery, or birth often require complex reconstruction. Current techniques involve hand sketched skin templates and/or hand carved cartilage grafts that are formed intraoperatively for nasal reconstruction. This process is time consuming, heavily depends on the surgeon's skill, cannot be standardized, and is difficult to visualize with patients preoperatively. To overcome these barriers and shift surgical paradigms, we will use a regenerative medicine approach to nasal reconstruction to create patient specific and individualized results. We will leverage regenerative medicine techniques of 3D surface mapping, 3D printing and modeling, and new tissue preparation techniques for skin template creation and sculpting of cartilage grafting. Clinically this will improve patient specific outcomes, increase reproducibility, reduce operative times, and allow for an individualized approach to nasal reconstruction. This will be achieved by (1) establishing ideal diced cartilage graft parameters in the laboratory setting for moldable cartilage graft formation. This knowledge will be applied to (2) create diced cartilage grafts for nasal dorsum and tip reconstruction from 3D printed nasal molds. For nasal skin reconstruction, (3) 3D facial scans of patients' preoperatively will be used to generate patient specific templates for skin reconstruction. Ultimately, (4) these regenerative medicine techniques of cartilage and skin reconstruction performed with 3D planning can be shared in an interactive format with patients preoperatively. This will allow patients to be involved in the surgical planning of their nasal reconstruction to increase their autonomy and the individualization of their surgery.

Eligibility Criteria:
Inclusion Criteria:

* Males or female, age range is ≥ 18 to ≤ 100, based on historical surgical experience.
* Patients undergoing nasal reconstruction.
* Patients will be identified from the Facial Plastic Surgery clinic of the PI.

Exclusion Criteria:

- Patients \< 18 are excluded because these cases are in combination with providers from PCH and patients have shared/limited postoperative follow up as a result.
Adjuvant Chemotherapy After Preoperative Chemoradiotherapy to Treat Rectal Cancer

The purpose of this study is to evaluate the disease-free survival in patients with locally advanced rectal cancer treated with preoperative chemoradiotherapy with fluoropyrimidines and surgery followed by adjuvant combination chemotherapy with oxaliplatin/5-FU/Leucovorin vs 5-FU/Leucovorin.

Preoperative chemoradiotherapy with fluoropyrimidines followed by surgery is one of the standard treatments for patients with locally advanced rectal cancer; however, the role of adjuvant chemotherapy is still controversial. The aim of this study is to investigate the efficacy of adjuvant FOLFOX for rectal cancer who underwent fluoropyrimidine based chemoradiotherapy and complete total mesorectal excision.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed adenocarcinoma of the rectum
2. Patients who treated with preoperative chemoradiation with fluoropyrimidines followed by curative surgery without microscopic residual tumor.
3. AJCC/UICC pathologic stages of ypT3-4 or ypN+
4. Curative surgery not less than 3 and not more than 8 weeks prior to randomization
5. No prior chemotherapy, radiotherapy and immunotherapy except preoperative chemoradiation for rectal cancer
6. ECOG PS 0-1
7. Adequate organ function
8. Informed Consent

Exclusion Criteria:

1. Macroscopic or microscopic evidence of remaining tumor
2. Any histologic feature other than adenocarcinoma or arisen from chronic inflammatory bowel disease
3. More than 8 weeks after curative surgery
SARS-CoV-2 (COVID-19) Detection Using the Breath Analizer TeraSystem

The purpose of the study is to verify the sensibility and accuracy of a rapid detection test for SARS-CoV-2 in breath samples analyzed by the breath detector analyzer TeraSystem, comparing with PCR tests.

BioSafety Technologies has developed a rapid detection test to clear people of COVID-19.

A person can undergo an easy non-invasive test, to determine if they are: COVID-19 Clear (Negative) or Infected (Positive). The user-friendly process does not involve medically trained personnel.

The study will compare TeraSystem test results against PCR test results. Persons participating will be persons having a PCR test as part of the Health System and consenting to participate.

Eligibility Criteria:
Inclusion Criteria:

Older than 7 years odf age Able to provide informed consent Able to take the breath test

Exclusion Criteria:

Younger than 7 years of age Unable to provide informed consent Unable to take the breath test
Emergency Pancreaticoduodenectomy: a Non-trauma Center Case Series

Pancreaticoduodenectomy is a challenging procedure itself, being even more complex and demanding in emergency settings. Only a few cases of emergency pancreaticoduodenectomy (EPD) are reported in medical literature, usually performed for complex pancreaticoduodenal lesions. EPD has first been mentioned in trauma settings, even fewer cases being reported for non-traumatic indications. The investigators intend to present our experience with this intervention, in a non-trauma surgical centre. Our study is a prospective consecutive case series, that included patients that underwent emergency pancreaticoduodenectomy from January 2014 to May 2021. Data was collected from the electronic system database. The investigators collected data regarding the demographic characteristics of the patients, their medical history, preoperative and postoperative investigations (including blood work and imagistic investigations), surgery related information and postoperative evolution.


Eligibility Criteria:
Inclusion Criteria:

* Emergency pancreaticoduodenectomy performed

Exclusion Criteria:

* Elective surgery
* Insufficient data
IGF-1, IGFBP3, ALS Normative Ranges in Healthy Pediatric Spanish Population

To determine the normative ranges of the Insulin-like Growth Factor 1 (IGF-1), Insulin-like growth factor-binding protein 3 (IGFBP-3), Acid-Labile Subunit (ALS) according to age, sex and pubertal stage of a healthy paediatric Spanish population.


Eligibility Criteria:
Inclusion Criteria:

* Children of either sex of Caucasian parents
* Age: newborns up to and including 18 years of age
* Length/height, weight and body mass index (BMI) within the mean +/- 2SD (Standard Deviation) and in accordance with the growth charts of the 2010 Spanish cross-sectional growth study (Carrascosa Lezcano et al 2010)
* Signed consent by at least one parent or legal guardian (if subject is ≤18 years) and by subject if ≥12 years

Exclusion Criteria:

* Early or advanced puberty (pubertal signs: between 8 and 9 years old in girls, and between 9 and 10 years old in boys), or delayed puberty (no puberty onset in ≥ 13 year-old girls, and in ≥ 14 year-old boys)
* Chronic diseases including, but not limited to, endocrinologic diseases, chromosomal diseases, chronic diseases of renal, hepatic and/or cardiac aetiology, and tumour processes
* An acute disease during the last two weeks prior to recruitment
* Any clinically significant out-of-range lab value
* Healthy paediatric volunteers who are under medical treatment (contraception permitted)
* A family history of short stature (either parent \< P3)
* Children born small for gestational age (birth weight, length, or head circumference \< P10)
* Adopted children or conceived through in vitro fertilization ( IVF )
* Subjects who are unwilling or unable in the opinion of the investigator or sponsor to undergo all the study procedures
The Pharmacokinetics and Safety of IDV/r With NRTIs in HIV/TB Co-infected Patients Receiving Rifampicin

We believe that there is a strong rationale for the study of IDV/r 600/100 bid as a boosted-PI combination that, in the presence of RMP, is able to produce a satisfactory PK profile associated with adequate antiretroviral potency, tolerability and efficacy.

The fixed-dose combination of d4T+3TC+NVP (GPOvir) has been widely used in Thailand since June 2002. The prevalence of NNRTI resistance has increased since 2005. Efavirenz-based antiretroviral therapy (ART) is preferred in patients with TB/HIV receiving rifampin-containing TB regimens. However, efavirenz cannot be used in the context of NNRTI failure, intolerance or toxicity. The optimal ART in populations receiving rifampicin remains unknown. Rifabutin, which is recommended in combination with a boosted protease inhibitor (PI/r) is expensive and not available in Thailand and other developing countries. Ritonavir-boosted indinavir (IDV/r) is potent and the cheapest boosted PI available in Thailand. If IDV/r in combination with rifampin demonstrates suitable pharmacokinetics and is well tolerated, this regimen might prove useful and could be widely implemented. However, high rates of gastrointestinal and renal toxicity have been demonstrated in Thai patients receiving standard doses of IDV/r 800/100 BID. We believe that there is a strong rationale to study if IDV/r 600/100 BID in combination with rifampin is able to produce a satisfactory pharmacokinetic profile, with antiretroviral potency, tolerability and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed HIV positive after voluntary counselling and testing
* Aged between 18 and 60 years of age
* Antiretroviral treatment naive
* CD4+ cell count of \<200 cells/mm3 at the time of TB diagnosis
* ALT \<5 times ULN
* Serum creatinine \<1.4 mg/dl
* Haemoglobin \>8 mg/L
* TB diagnosis; either probable (clinical symptoms plus chest x-ray and response to anti-TB medication) or definitive( sputum AFB culture confirmed) and receiving or planning to receive rifampicin-containing anti-TB therapy for at least a 2 week period before the initiation of ART
* No other active OI (CDC class C event)
* Able to provide written informed consent

Exclusion Criteria:

* Current use of steroids and other immunosuppressive agents
* Current use of any prohibited medications related to compliance and drug pharmacokinetics
* Patients with current alcohol or illicit substance use that in the opinion of the site Principal Investigator would conflict with any aspect of the conduct of the trial.
* Previous exposure to nevirapine monotherapy
* Unlikely to be able to remain in follow-up for the protocol defined period
* Patients with proven or suspected acute hepatitis. Patients with chronic viral hepatitis are eligible provided ALT, AST \< 5 x ULN.
* Karnofsky performance score \<30%
Analysis of the Different Strategies for Revascularization of the Lower Limbs by Peripheral Angioplasty

Peripheral arterial disease (PAD) caused by atherosclerosis causes damage to the arteries originating in the aorta (descending) from the iliacs to the extremities of the lower limbs. It causes significant morbidity and mortality. Percutaneous revascularization plays a key role in the management of these patients. Many percutaneous treatment options have been developed: arteriectomy, naked stents, active balloons and active stents. Of these, only paclitaxel-active stents were successful in reducing the rates of restenosis and reoperation in patients with superficial femoral artery injury.The main objective is to study symptomatic improvement at 1 year of patients treated with revascularization of the lower limbs.


Eligibility Criteria:
Inclusion Criteria:

* Patient treated by the peripheral angioplasty department of Claude Galien Hospital from January 2010 and with at least 1 year of follow-up after the revascularization procedure
* Patient treated for symptomatic chronic ischemia of the lower limbs defined by Rutherford categories 2-4 and / or Leriche stage greater than 2a
* Stenosis or restenosis (history of balloon angioplasty, active balloon or bare stent)
* Degree of stenosis ≥ 50% by angiographic evaluation visual, by CT scan or by Doppler ultrasound
* Patient affiliated or beneficiary of a social security scheme
* Patient aged 18 or over
* Patient having been informed and not opposing this research

Exclusion Criteria:

* Medical history of myocardial infarction or stroke within 3 months of the revascularization procedure
* Unstable angina at the time of the revascularization procedure
* Sepsis at the time of the revascularization procedure
* Major under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
* Hospitalized without consent
* Pregnant, breastfeeding or parturient woman
OSA in Children Referred for Adenotonsillectomy

In children with OSA (Obstructive sleep apnea) adenotonsillectomy is regarded as the first choice of treatment. Studies in recent years have shown that the procedure does not always have the expected effect. Children with OSA are at greater risk for complications from the procedure.

There is disagreement regarding the need for sleep studies in children prior to surgery in order to verify an OSA diagnosis. Today less than 10% of these children have polysomnography (PSG).

The main purpose of this study is to describe the prevalence of OSA among children referred for adenotonsillectomy.

The investigators will also examine these children prior to and six months after surgery to assess their sleep pattern and quality of life.

The project outcome aims to improve the precision and quality of diagnosis and the short and long term effects of treatment of children with OSA.


Eligibility Criteria:
Inclusion Criteria:

* age 2-5 year
* referred for adenoidectomy and/or tonsillectomy

Exclusion Criteria:

* craniofacial anomalies
* neurological diseases
* neuropsychiatric diseases
A Study to Evaluate the Safety and Tolerability of Rizatriptan for Long Term Treatment of Acute Migraine in Children and Adolescents (MK-0462-086 AM3)

To provide long term safety data for rizatriptan in children and adolescents. The primary hypothesis of the study is that rizatriptan is well tolerated in the long term treatment of acute migraine in pediatric patients age 12-17 years.


Eligibility Criteria:
Inclusion Criteria:

* Patient is between 12 and 17 years of age inclusive at screening Visit 1
* Patient weighs at least 20 kg (44 pounds)
* Patient has had a history of unilateral or bilateral migraine headache with or without aura \>6 months with ≥1 to ≤8 mild, moderate or severe migraine attacks per month in the 2 months prior to screening Visit 1
* Patient has a history of migraine defined by International Headache Society (IHS) migraine definitions
* The parent or guardian and patient agree to the patient's participation in the study as indicated by parental/guardian signature on the consent form and patient assent
* For patients taking migraine prophylactic medication, treatment regimen is stable and has been taken for at least 3 months prior to Visit 1

Exclusion Criteria:

* Patient is pregnant or breast-feeding, or is a female expecting to conceive within the projected duration of study participation
* Patient has a history of mild migraine attacks or migraines that resolve in less than 2 hours
* Patient has basilar or hemiplegic migraine headaches
* Patient has \>15 headache-days per month OR has taken medication for acute headache on more than 10 days per month in any of the 3 months prior to screening
* Patient has uncontrolled high blood pressure, uncontrolled diabetes, human immunodeficiency virus (HIV), any cancer, or any other significant disease
* Patient has a history cardiovascular problems or stroke
* Patient has either demonstrated hypersensitivity to or experienced a serious adverse event in response to rizatriptan
* Patient has demonstrated hypersensitivity to or experienced a serious adverse event in response to 3 or more classes of drugs (over-the-counter and prescription)
* Patient did not experience satisfactory relief from migraine pain to prior treatment with 2 or more adequate courses of 5-hydroxytryptamine 1 (5HT1) agonists
* Patient has a recent history (within the past year) or current evidence of drug or alcohol abuse or is a "recreational user" of illicit drugs
* Patient is currently taking monoamine oxidase inhibitors, methysergide, or propranolol, and is unable to tolerate withdrawal of these medications for the intervals required
* Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of screening
* Patient is legally or mentally incapacitated