cyrilzakka/clinical-trials huggingface dataset:
A Post Marketing Surveillance As Required By Philippine Food And Drug Administration

This is a post marketing surveillance which determines the safety profile of the product to Filipinos. This is a FDA requirement for registration.

The Philippine Food and Drug Administration requires that a post marketing surveillance study be conducted nationwide and enroll approximately 3,000 study patients. In cases where the 3,000 patients will not be met, the total sample size can be reduced to 10% of the volume of drug use during the first year of it being marketed. Final sample size will be determined after one year of marketing authorization. The decision to use Torisel must be a joint decision made by the subject and the investigator.

The investigator must discuss product information with the subject as per usual practice.

Eligibility Criteria:
Inclusion Criteria:

* Subjects that will be included in this post marketing surveillance study must be consistent with the approved label indication of Torisel in the Philippines.
* As per approved label indication, patients diagnosed with advanced renal cell carcinoma will be the ones eligible to participate in the study.
* The decision to prescribe Torisel will necessarily precede and will be independent of the decision to enroll the patient into the study.
* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Subjects with conditions that are contraindicated with Torisel based on the approved local product document in the Philippines will be excluded in this study. This condition includes: Patients with bilirubin \>1.5 x ULN.
Concordance and Acceptability of Self-screening Versus Screening by a Healthcare Professional for HPV, a Risk Factor for Anal Cancer, by Swab in People Living With HIV

Anal canal cancers are on the increase in France, with around 2,000 new cases per year. These lesions can be detected by directed biopsies or smear tests.

The incidence rate of anal cancer is 30 times higher in people living with HIV than in the general population.

According to a recent study, the risk of anal cancer is highest in this population, but is also high in heterosexual men over 30 and women over 30. However, the proposal of a proctological examination in this population is not systematic.

In France, there is no HPV screening for people living with HIV, but there is a recommendation for proctology consultation in certain cases, notably for men who have sex with men (MSM) or for women with vaginal cervical lesions.

Several oncogenic HPV serotypes have been identified in the genesis of anal cancer. The serotype identified as the most carcinogenic is HPV-16 (89%).

This study will look at anal HPV screening in people over 30 living with HIV, thus including a population for which no screening is currently offered (heterosexual men living with HIV and women living with HIV without vaginal cervical lesions), and will assess the concordance and acceptability of self-screening versus screening by a healthcare professional as part of a comprehensive anal cancer screening strategy in this population.


Eligibility Criteria:
Inclusion Criteria:

Patient :

* living with HIV
* aged 30 or over
* resident on Reunion island and followed at the University Hospital of Reunion Island (the only follow-up center on the island)
* Able to perform anal self-sampling
* Able to answer a questionnaire
* Affiliated with or benefiting from a social security scheme
* Have given free, informed and signed consent

Exclusion Criteria:

* People with a previous anal swab less than 7 days old
* Persons with a known current diagnosis of anal cancer
* Persons deprived of liberty by judicial or administrative decision, minors, and persons under legal protection: guardianship or curators
Study of the Adequacy Between Calcium Supplementation and Dietary Intake in Treatment-naive Patients After a Fracture

Osteoporosis is a disease that causes many fractures. However, treatments exist such as anti-osteoporotic treatments, vitamin D supplementation and an adaptation of calcium intake. 80% of patients with an indication for anti-osteoporotic treatment are never treated with these anti-osteoporotic treatments after a first fracture. On the other hand, more than 84% of them are supplemented with calcium and vitamin D. It often appears in the practice of rheumatologists that some patients are supplemented while their dietary intake is sufficient, and vice versa. The objective of the study is therefore to take stock of the (in)adequacy between the dietary intake of patients and the supplementation prescribed to them following an osteoporotic-like fracture.


Eligibility Criteria:
Inclusion Criteria:

* Patient meeting a first rheumatologist after a fracture suspected of being due to bone insufficiency, whether or not he is already treated for osteoporosis
* Age ≥ 18 years
* Patient followed in one of the three investigation centers within the framework of the bone sector.
* Patient affiliated to a social security system

Exclusion Criteria:

* Patient refusing to participate in the study
* Patient already followed by a rheumatologist
* Legal incapacity or any physical, psychological, social or geographical condition likely to hinder the patient's ability to participate in the study
Heat Loss Prevention in Delivery Room Using a Polyethylene Cap

It is apparent that the head of a preterm infant should not be left uncovered, however it remains unclear whether covering the head of a preterm baby with plastic wrapping is effective in preventing heat loss.

We conducted a prospective, randomised, controlled trial in very preterm infants to evaluate if a polyethylene cap prevents heat loss after delivery better than polyethylene occlusive wrapping and conventional drying. Furthermore, we assessed body temperature 1 hour after admission to Neonatal Intensive Care Unit (NICU) to evaluate whether the polyethylene cap prevents postnatal heat loss.

The primary outcome measure was axillary temperature taken on admission to the NICU (immediately after cap and wrap removal) and again 1 hour later. Axillary temperature was measured using a digital thermometer (Terumo Digital Clinical Thermometer C202, Terumo Corporation, Tokio, Japan). The occurrence of hypothermia, defined as axillary temperature less then 36.4°C, on NICU admission was also evaluated.

Secondary outcomes included mortality prior to hospital discharge, presence of major brain injury (sonographic evidence of intraventricular hemorrhage with ventricular dilatation, parenchymal hemorrhagic infarction, or periventricular leukomalacia), tracheal intubation at birth, Apgar scores, delivery to admission time, blood gas analysis and serum glucose concentration on NICU admission.

Eligibility Criteria:
Inclusion Criteria:

* infants \<29 weeks' gestation born in the study center.

Exclusion Criteria:

* congenital anomalies with open lesions (e.g. gastroschisis, meningomyelocele) and babies whose delivery was not attended by the neonatal team.
Effect of Prime Solution on Fluid Balance After Open Heart Surgery

The use of Tetraspan® as prime solution can reduce fluid extravasation after perfusion versus Ringer acetate. Plasma-adapted HES-solutions produce also less acidosis.

Fifty patients scheduled for elective primary and single cardiac surgery include in this prospective study. Patients with preoperative coagulation disorders, or renal or hepatic failure, are excluded.

Before admission to the operation theatre, the patients allocate in random order to receive one of the following solutions during the extracorporeal circulation:

1. Ringer-acetate solution
2. 6% HES solution (Tetraspan®) During the 1 postoperative day we register hemodynamic changes, fluid balance, fluid extravasation, plasma ion concentration, modified thromboelastography, and kidney function.

Eligibility Criteria:
Inclusion Criteria:

* Elective combined cardiac surgery

Exclusion Criteria:

* Liver failure
* Kidney failure
Exopulse Mollii Suit, Spasticity & Tissue Oxygenation

Spasticity is a frequent and debilitating symptom in patients with multiple sclerosis (MS). Sustained contractile activity, such as that observed in spastic muscles, could reduce the capillary density and induce important changes in the muscular microcirculation, leading to oxidative changes within the muscular tissue. Such changes reflect altered aerobic metabolism and impaired mitochondrial function. The available therapeutic strategies for treating spasticity and related symptoms are usually faced with limited efficacy and numerous side effects. For these reasons, non-invasive stimulation techniques, namely transcutaneous stimulation by means of Exopulse Mollii suit, might be of help in this context.


Eligibility Criteria:
Inclusion Criteria:

* Definite MS diagnosis according to the 2017 McDonald criteria since at least one month.
* Age between 18 and 75 years.
* Ability to walk freely or with the need of support (expanded disability status scale score (EDSS) \< 7.5).
* Being free of relapses in the last three months.
* Being French speaker, able to understand verbal instructions, and affiliated to the national health insurance (sécurité sociale).
* Having spasticity with a score of at least 1+ on the MAS.

Exclusion Criteria:

* Being included in another research protocol during the study period.
* Inability to undergo medical monitor for the study purposes due to geographical or social reasons.
* Having a cardiac stimulator, a ventriculoperitoneal shunt, an intrathecal baclofen pump or other contraindications to using Exopulse Mollii suit.
* Being pregnant
* Having a change in their pharmacological therapy in the last three months.
* Suffering from other somatic or neuropsychiatric diagnoses (e.g., arrhythmias, uncontrolled epilepsy, diseases causing osteoarticular and muscular pain).
* Having a body mass index above 35 Kg/m2
* In case of the introduction of a medical device other than Exopulse Mollii suit during the study period.
* Patients under juridical protection (" mesure de protection judiciare : tutelle, curatelle, sauvegarde de justice ")
* Prisoners.
IBD Shared Decision Making Intervention

The purpose of this clinical trial is to implement a multi-component shared decision making intervention for families of children with IBD. The main objective of this research will be to assess the acceptability, feasibility and clinical and decision outcomes of a multi-component decision support intervention targeted at families of children with IBD who are making decisions about treatment with TNFαi agents.

Research has shown that when making decisions about treatment with anti-tumor necrosis factor-α (TNFαi) agents, parents of children with inflammatory bowel disease (IBD) experience high levels of decisional conflict. This extreme level of conflict is due to the challenge of considering an effective treatment that has potentially serious side-effects. Elevated levels of decisional conflict have been associated with delays in decision making and failures to implement treatment plans. Given that such delays may lead to worse clinical outcomes, there is an urgent need to improve the decision-making process around TNFαi therapy. The use of structured decision support to help inform and guide parents through this challenging decision may improve the decision-making process. Such structure facilitates high-quality decision making by providing balanced, accurate information, helping individuals clarify what is most important to them, and facilitating conversations between families and healthcare providers. Based the investigators' prior research into the TNFαi decision process, the investigators developed a multi-component decision support intervention designed to improve the TNFαi decision process. This intervention will be tested in a controlled pilot trial designed to assess the acceptability and feasibility of a multi-component intervention and to determine the effect size of the multi-component intervention on both clinical and decision outcomes in children and adolescents with IBD and their parents.

Eligibility Criteria:
Inclusion Criteria:

* Clinician anticipates discussing TNFai treatment at clinic visit; parent and patient willing to have visit video-recorded

Exclusion Criteria:

* patient over age 17; prior use of TNFai; unable to read and speak English; clinic visit not conducted in English; previous participation in this study; known major mental illness in parent or adolescent patient; medical instability at scheduled visit; patient's gastroenterologist is a study investigator
Psychological Assessment and Treatment of Chronic Benign Headache

Subjects with chronic migraine or tension headaches will receive 12 sessions of biofeedback or relaxation training after fulfilling screening, intake interviews, \& psychological testing requirements. They will chart headache pain, anger level, \& medication usage throughout baseline, treatment, and 3 month follow-up periods.

Migraine sufferers will receive a combination of progressive muscle relaxation training and thermal biofeedback (learning to warm hands). Subjects are randomly assigned to receive treatment either in the office with the therapist or from another room (where communication will be over a computer). The research is designed to compare the effectiveness of treatment based on location.

Tension headache sufferers will receive training in how to reduce their muscle tension levels. They will be randomly assigned to have equipment monitor muscle tension levels either in the forehead or shoulder regions. The research is designed to compare the effectiveness of feedback to the forehead versus the shoulder muscles.


Eligibility Criteria:
Subjects must be at least 18 years old and have chronic headaches of any of the following types: migraine, coexisting migraine/tension, or tension. Participants must be intellectually intact and have no significant physical, neurological, or psychological problems. They must have seen a physician for their headaches within the past year. They must successfully complete screening/interview/testing process prior to admission to treatment.

All vascular headache subjects must meet the criteria for chronic migraine or coexisting migraine and tension type headache as set forth by the Headache Classification Committee of the International Headache Society.

All tension headache subjects must meet the criteria for either episodic or chronic tension headache set forth by the Headache Classification Committee, as well as the Ad Hoc Committee's criteria for tension headache.
Aronia and Cognitive Fitness

Previously, beneficial effects of Aronia Melanocarpa extract (AME) supplementation on cognitive performance has been observed in healthy middle-aged adults. However, underlying mechanisms have not yet been addressed. In addition, effects of AME are unknown in subjects at increased risk of cognitive impairment. It is hypothesized that supplementation with AME enhances (regional) brain vascular function and brain insulin-sensitivity, thereby improving cognitive function of subjects at increased risk of cognitive impairment.

The primary objectives are to investigate effects of AME intake on brain vascular function and insulin-sensitivity in cognitive-control brain areas, while we will also evaluate changes in cognitive function (secondary objective).

The present study is a randomized, double-blind, placebo-controlled, cross-over trial consisting of two study groups and a pre- and post-test day in both study arms.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, aged between 55-75 years
* BMI between 25-35 kg/m2
* Fasting plasma glucose \< 7.0 mmol/L
* Fasting serum total cholesterol \< 8.0 mmol/L
* Fasting serum triacylglycerol \< 4.5 mmol/L
* Systolic blood pressure \< 160 mmHg and diastolic blood pressure \< 100 mmHg
* Stable body weight (weight gain or loss \< 3 kg in the past three months)
* Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study
* No difficult venipuncture as evidenced during the screening visit

Exclusion Criteria:

* Smoking or smoking cessation \< 12 months
* Presence of diabetes mellitus
* Active cardiovascular disease like congestive heart failure or cardiovascular event
* Severe medical conditions, including asthma, chronic obstructive pulmonary disease (COPD), kidney failure, auto-inflammatory diseases or rheumatoid arthritis
* Unstable body weight (weight gain or loss \> 3 kg in the past three months)
* Use of dietary supplements or medication affecting the main outcomes of the study
* Use of an investigational product within another biomedical intervention trial within the previous month
* Contra-indications for MRI imaging (e.g., pacemaker, surgical clips/material in body, metal splinter in eye, claustrophobia)
* Left-handedness
* Familial hypercholesterolemia
* Abuse of drugs
* More than 3 alcoholic consumptions per day
* Use medication to treat blood pressure, lipid or glucose metabolism
Efficacy Study of the Medical Device TRP Snorless™ in the Treatment of Snoring

The Tongue Right Positioner (TRP Snorless™) is a medical device designed to restore physiological tongue positions when functioning or at rest and increase tongue muscles tone. Patient wears TRP Snorless™ daily at least 5 hours during night. Published data suggested that TRP Snorless™ increases oropharynx diameter and nasal patency, favouring airflow in upper airways. Independently of patient's adherence to daily myofascial exercises, the TRP Snorless™ treatment should increase tongue muscles' tone and decrease the risk of snoring during sleep.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman ≥ 18 years and ≤ 65 years at the time of signing informed consent
* Listed as continuous snorer (snoring at least 4 nights/week)
* Answer "Extremely loud" or "very loud" to question 1 of SBPS at screening
* Answer "very severe" or "severe" to question 2 of SBPS at screening
* Answer "extremely" or "quite a bit" to question 3 of SBPS at screening
* Dated and signed informed consent
* BMI ≤ 35

Exclusion Criteria:

* Severe Mandibular retrognathia and micrognathia
* Narrow and deep palate (less than 3 cm wide)
* Lack of three consecutive teeth in the area of (15-16-17-18) or (25-26-27-28).
* Lingual or labial short frenulum (the tongue cannot reach the upper incisors when mouth can be opened for two fingers)
* Intolerable gag reflex
* Known nasal septal deviation
* Neck circumference \> 46 cm
* Patient currently treated for OSA
* Patient with AHI≥30 events/hour or with AHI\>15 and (SFI) Sleep Fragmentation Index \> 20
* Patient currently treated for central sleep apnoea
* Addiction to alcoholic beverages (5 drinks per day per NIAAA)
* Under constant pharmacological treatment for depression, anxiety, chronic pain, insomnia
* Hypertrophy of tonsils
* Macroglossia
* Hypertrophy of uvula
* Primary gastroesophageal reflux
* Any other pathology preventing subject from complying with the protocol
* Subject with recent oropharyngeal surgery or likely during the study
* Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures
* Pregnancy
* Patient with severe Chronic Obstructive Pulmonary Disease
* Asthmatic patient under inhaled corticoid therapy
Does Routine Submucosal Injection Improve Complete Resection of 4-20 mm Neoplastic Colorectal Polyps?

This is a prospective, multi-endoscopist, single center, clinical study at tertiary referral center that addresses an important current challenge in the prevention of colorectal cancer (CRC), namely, how to improve the complete removal of CRC precursors. This study will observe the potential benefit of specific polypectomy technique in conjunction with a systematic submucosal injection prior to the polyp resection. This study will evaluate the completeness and incompleteness of the resection of colorectal neoplastic polyps during the procedures.

Non-detection and incomplete resection of neoplastic colorectal polyps have been identified as the main risk factors for the development of CRC in patients after a colonoscopy. Between 7% and 9% of all newly diagnosed CRCs are estimated to be such "interval cancers," occurring after a previous colonoscopy and before the next surveillance examination. The vast majority of interval cancers are caused by incomplete detection or resection during colonoscopy examination. The contribution of incomplete resection towards interval cancer has recently been pointed out by a panel of experts as one of the cornerstones of CRC prevention that need to be addressed in future research studies. The primary aim of this study is to examine the incomplete adenoma resection rates when performing a cold snare polypectomy in conjunction with a submucosal injection for endoscopic resection of 4-20 mm non-pedunculated colorectal polyps. The subjects are patients, men and women, aged between 45-80 years old that are scheduled for a colonoscopy. The secondary aims are to identify procedure-related complication rates and patient-, polyp-, and endoscopist-related factors associated with incomplete adenoma resection.

Eligibility Criteria:
Inclusion Criteria:

* Signed consent form; aged 45-80 years old, indication to undergo a colonoscopy

Exclusion Criteria:

* Known inflammatory bowel disease; active colitis; coagulopathy; familial polyposis syndrome; poor general health, defined as an American Society of Anesthesiologists (ASA) physical status class \>3; emergency colonoscopies, hospitalized patients or patients referred from the emergency room.
PK Papyrus Covered Coronary Stent System

The PK Papyrus Covered Coronary Stent System is a coronary stent being used at Methodist Dallas Medical Center for patients with coronary perforations.

The FDA has approved the PK Papyrus Covered Coronary Stent System for use in patients being treated for acute perforations of native coronary arteries and coronary bypass grafts in vessels ranging from 2.5 to 5.0 mm in diameter, under a Humanitarian Device Exemption (HDE #H170004). Methodist Dallas Medical Center will use this device for treating the above-described patient population.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute perforations of native coronary arteries and coronary bypass grafts in vessels 2.5 to 5.0 mm in diameter

Exclusion Criteria:

* Patients in whom antiplatelet agents or anticoagulation therapy is contraindicated.
* Patients with a known allergy or hypersensitivity to amorphous silicon carbide or any other compound of the system (siloxane-based polyurethane, L-605 cobalt chromium alloy including tungsten and nickel).
* Lesions that cannot be reached or treated with the system.
* Lesions with threatened or abrupt closure during attempted pre-dilation prior to stent implantation.
* Risk of treatment-related occlusion of vital coronary artery side branches.
* Uncorrected bleeding disorders.
* Allergy to contrast media.