cyrilzakka/clinical-trials huggingface dataset:
Study Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia.

The primary objective is to demonstrate the analgesic effect at day 60 of 8% capsaicin patch (Qutenza) for the treatment of patients with coccygodyinia.

This trial is a French, multicenter, randomized, controlled, bouble-blind and prospective study. Patients enrolled will be clinically followed for 5 months. The treatment duration per subject is 1 hour (1time).

Eligibility Criteria:
Inclusion Criteria:

* \>18 years old at the pre-inclusion visit
* Presenting with chronic coccygodynia: pain in the coccygeal region, increased by sitting and or when rising from a sitting position and pain over the last ten days of intensity greater than or equal to four on the eleven-point numerical scale (from zero to ten) and having been present for more than 3 months.
* Failure of previous treatments: NSAIDs, pressure-relieving cushions and/or infiltration or having a contraindication to these treatments, or not wishing to receive these treatments
* Have never been treated with an 8% capsaicin patch for this indication
* With at least one clinical sign suggestive of neuropathic pain (burning, painful cold, numbness, tingling, electric discharge, allodynia of the gluteal groove, allodynia to pressure on the coccyx)
* Proficiency in reading and writing the French language
* Be affiliated to the social security system
* Have signed an informed consent form
* Women must meet one of the following criteria at the time of inclusion:
* be using adequate contraceptive measures, and have a negative pregnancy test (specify if urine or blood test) prior to receiving the first dose of trial medication;
* or be post-menopausal (aged over 50 with amenorrhoea for at least 12 months after stopping all exogenous hormonal treatments)
* or (if under 50) have been in amenorrhoea for at least 12 months after stopping all exogenous hormone treatments and with luteinising hormone (LH) and follicle stimulating hormone (FSH) levels corresponding to post-menopausal levels.
* or have undergone irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy (this operation must be documented).

Exclusion Criteria:

* Coccygodynia accompanied by a dermatological lesion in the intergluteal cleft (psoriasis, pilodinial cyste, wound)
* Patients with other major pain disorders likely to interfere with pain assessment
* Hypersensitivity to capsaicin or to one of the excipients
* Adults under legal protection (guardianship, curatorship, legal protection)
* Pregnant or breast-feeding women
* Patients who have undergone total coccygectomy
Effect of Goal-directed Hemodynamic Therapy on Short-term Postoperative Complications in Patients With Extensive Burns

To investigate the effect of goal-directed hemodynamic management on perfusion and short-term prognosis of patients undergoing scab grafting in early stage of extensive burns.

Objective: To investigate the effect of goal-directed hemodynamic management on perfusion and short-term prognosis of patients undergoing scab grafting in early stage of extensive burns.

Methods: Ninety-five patients with extensive burns undergoing early debridement grafting were randomly divided into a standard hemodynamic management group (control group) and a goal-directed hemodynamic therapy group (GDHT group), with the control group guided by conventional parameters and the GDHT group guided by SV based on Vigileo. The primary outcome were incidence of cardiac complications, pulmonary complications, neurological disease, acute kidney injury, and pain within 7 days postoperatively. Secondary outcome included microcirculatory perfusion metrics: Lactate (lac), The central venous-arterial carbon dioxide partial pressure difference (Pcv-aCO2).

Eligibility Criteria:
Inclusion Criteria:

1. the age is between 18 and 65 years old;
2. the burn area ≥ 50% total burn surface area (TBSA) or the third degree wound area ≥ 20% TBSA;
3. patients will undergo the first operation after fluid resuscitation (after the shock period). The types of operation include incision decompression, escharectomy and skin grafting, and so on.

Exclusion Criteria:

1. Severe cardiac or pulmonary disease prior to the burn injury, combined with severe internal organ damage.
2. Patients or family members refusing informed consent for this study.
Optimizing NIPPV Use for Patients With ALS

This research will examine the utility of the data card recording capacity of nasal ventilation devices (NIPPV) in people with ALS to optimize use.

The data card records critical features of NIPPV acceptance (hours and timing of use) and adherence (apnea/hypopnea index, mask leak, minute ventilation); but to date data card monitoring has not yet been incorporated fully into ALS clinic practice. We will limit our focus to patients who meet Medicare-reimbursement criteria or AAN-recommended practice parameters for initiating NIPPV. The larger question guiding this research is whether data card monitoring and communication of these results to clinicians and patient families promotes "optimal use" of NIPPV. We define optimal use as (i) high acceptance, as indicated by daily night time use greater than 4 hours, and (ii) high adherence, as indicated by apnea/hypopnea index, mask leak, and minute ventilation. We will test whether timely reporting of acceptance and adherence values to patients and clinicians increases the likelihood of (i) changes in orofacial masks and settings on devices and continued use of devices, and (ii) positive patient mood and sleep quality and lower caregiver burden over follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Definite or probable ALS
* Medicare or AAN criteria for initiating NIPPV
* Community resident
* English speaker

Exclusion Criteria:

* Unable to give informed consent
* Other pulmonary or cardiac conditions that complicate use of NIPPV
* Report from physician that participation would be harmful
Myeloma Treatment in Real Life

As part of an oral treatment regimen in ambulatory practice, certain uses in connection with drug consumption associated could alter treatment outcomes observed in randomized clinical trials.

The increase in progression-free survival in myeloma may be accompanied by an impaired quality of life and a resurgence of pain symptoms over time, which could potentially lead to medication overuse involving painkillers but also psychotropic drugs. These combined consumption may affect survival through mechanisms of pharmacological or non-pharmacological interactions.

As part of this project, we wish to explore the scheme of adherence to myeloma drugs, and thus validate the decision diagram of hypothesis of not adequate of drug use in ambulatory conditions, from observational data. This discrepancy could result from poor adherence or suboptimal drug use but also from concomitant exposures to other drugs which may interact with myeloma. Before considering a study of greater magnitude that could address the consequences of non optimal drug use on clinical response criteria, such as duration of response or survival, it seems appropriate to confirm these assumptions within ' an exploratory study.


Eligibility Criteria:
Inclusion Criteria:

* Beneficiaries or entitled to health insurance or covered by the national system of information of health insurance
* Identified as multiple myeloma
* Incident patient : Subject presenting none of inclusion criteria during the 6 months observation period

Exclusion Criteria:

* Non incident patient : Subject presenting at least one of inclusion criteria during the 6 months observation period
Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial

The most common cause of fetal tachycardia is maternal fever. Fetal tachycardia often precedes the maternal fever, and fetal tachycardia confounds the interpretation of electronic fetal monitoring (EFM), increasing the rate of cesarean delivery for non-reassuring fetal status (NRFS). Our hypothesis is that treatment of fetal tachycardia with acetaminophen will significantly lower maternal body temperature and significantly lower baseline fetal heart rate (FHR). The importance is that interpretation of EFM will improve, thus allowing for a decrease in cesarean delivery for NRFS.

This trial is a randomized, non-placebo controlled, assessment of whether acetaminophen can lower maternal temperature and baseline fetal heart rate in laboring patients with fetal tachycardia.

Term singleton cephalic pregnancies in active phase labor (spontaneous or induced) with fetal tachycardia will be recruited. Patient will be excluded for:

* Exclusion criteria (prior to randomization):
* Acetaminophen allergy
* Clinical chorioamnionitis
* Maternal fever
* Non-reassuring fetal status (NRFS), which is the designation for fetal heart rate abnormalities requiring cesarean delivery
* Previous cesarean delivery
* Multifetal gestation
* Breech presentation
* Known fetal anomaly
* Known contraindication to vaginal delivery

Primary outcome measures are:

1. Maternal body temperature (oral) 90 minutes after treatment
2. Baseline FHR

Secondary outcome measures are:

1. Temperature difference before and after treatment
2. Rate of cesarean delivery
3. Rate of determination of NRFS
4. Rate of subsequent development of maternal fever
5. Rate of diagnosis of clinical chorioamnionitis
6. Rate of neonatal sepsis

Power calculation Internal data collection at our institution of 53 patients showed a mean decrease in temperature of patients in labor with fever receiving acetaminophen is 0.3 degrees C measured an average (mean) of 90 minutes after administration of acetaminophen. Mean oral temperature before acetaminophen was 38.32, SD 0.33. Mean oral temperature after acetaminophen was 38.03, SD 0.85.

Sample size calculation shows that 27 patients are needed in each group to show significant difference using alpha 5% and beta 50%.

Eligibility Criteria:
Inclusion Criteria:

* Term pregnancy
* Singleton pregnancy
* Pregnancy with cephalic presentation
* Pregnancy in active phase labor
* Fetal tachycardia

Exclusion Criteria:

* Acetaminophen allergy
* Clinical chorioamnionitis
* Maternal fever
* Non-reassuring fetal status or fetal heart rate abnormalities requiring cesarean delivery
* Previous cesarean delivery
* Multifetal gestation
* Breech presentation
* Known fetal anomaly
* Known contraindication to vaginal delivery
MARS: Magnetic Resonance Study: A Novel Assessment of Placental Function

The objective of this study is to evaluate functional MRI as a tool to study placental transfer of oxygen and nutrients during the third trimester of pregnancy in obese women, women with pregestational diabetes and healthy low risk women without these conditions (controls). The investigators hypothesize that altered placental function, including diminished placental oxygenation and enhanced placental transport of lipids and metabolites will be seen in obese and pregestational diabetics as compared to controls.

In this study, we propose to utilize two novel and innovative non-invasive tools to measure placental oxygenation and lipid and nutrient transport in vivo in women who are obese (OB), have pregestational diabetes (DM) or have neither (controls). To evaluate differences in placental oxygenation, we propose to use Blood Oxygen Level Depending (BOLD) imaging, a method of functional magnetic resonance imaging, to measure tissue oxygenation in the placenta during the third trimester of pregnancy. To evaluate placental lipid and nutrient content, we propose to utilize Magnetic Resonance Spectroscopy (MRS), a novel and powerful tool to compare lipid and nutrient transport across the placenta among OB, DM and controls.

To confirm in vivo BOLD and MRS findings, we will extensively evaluate the placental lipid content and lipid transport capability. Fatty acid transport protein-4 (FATP-4), one of 6 FATP proteins, is important for placental lipid accumulation, especially LC-PUFA21-24. Docosahexaenoic acid (DHA) is a crucial LC-PUFA for neurogenesis in early development18. Major facilitator super family domain containing MFSD2a is a lysophospholipid transporter required for DHA uptake in the brain and has been linked to placental DHA transfer. Lipid content of the placenta can be assessed by visualizing lipid droplets via perilipin 2, the most abundant structural protein on the surface of lipid droplets of adipocytes.

We hypothesize that altered placental function including diminished placental oxygenation and abnormal placental transport of lipids and other metabolites will be seen in OB and DM women as compared to controls. We further hypothesize that ex vivo placental pathologic, histologic and immunohistochemistry characteristics will be associated with in vivo findings. Our findings from this pilot study have the potential to serve as the basis of a larger study to further evaluate the potential impact of BOLD and MRS technology on our understanding of placental lipid and oxygen transport among women with obesity and pregestational diabetes as compared to women without these conditions.

Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy
* planned cesarean section

Exclusion Criteria:

* non-English speaking
* fetal anomalies
* gestational diabetes mellitus
A Clinical Study of the C8 MediSensors Optical Glucose Monitor™

The purpose of this study is to compare glucose measurements from the C8 MediSensors non-invasive Optical Glucose Monitor™ System to blood glucose measurements from the Yellow Springs Instrument(YSI) blood glucose analyzer.

This is a prospective, non-randomized, open label study to evaluate the performance of the C8 MediSensors non-invasive Optical Glucose Monitor™ on individuals with diabetes mellitus. Capillary blood samples will be obtained throughout a daily study session; the study session may last for up to 12 hours. Blood glucose will be measured on a YSI blood glucose analyzer. Subjects may adjust food intake and insulin administration so device performance is evaluated across a broad range of glucose concentrations. Glucose measurements will be time matched and paired for comparison. Skin effects and adverse events will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older.
2. Understands and agrees to comply with study instructions.
3. Read, understood, signed and dated the Informed Consent Form.

Exclusion Criteria:

1. Pregnancy.
2. Extensive skin changes or diseases that preclude wearing the test device at the proposed wear site(s) (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis).
3. Employed by a company within the diabetes field other than the study sponsor.
4. Medical history or any condition that may, in the opinion of the investigator, compromise the subject's ability to participate.
PrEP and Consumptions

HIV pre-exposure prophylaxis (PrEP) with Truvada®, a combination of two antiretrovirals (tenofovir \& emtricitabine) is a prevention strategy for HIV-negative people at high risk of acquiring HIV. PrEP has thus been integrated as a new tool to significantly reduce the risk of HIV infection, especially among men who have sex with men (MSM). Since its introduction, an increase in sexually transmitted infections (STIs) has been observed, particularly in relation to the use of psychoactive substances in a sexual context (Chemsex).

In this context, the description and evaluation of these practices seem necessary, as well as the impact on the risk of addiction and mental health.

Interventional, multi-center pilot study, including all subjects aged 18 years or older presenting in consultation for a PrEP renewal.

The newsletter and a self-questionnaire will be systematically given in the waiting room to any PrEP consultant to evaluate the consumption of psychoactive substances (ASSIST questionnaire) and to identify anxio-depressive disorders (HAD questionnaire - Hospital Anxiety and Depression). scale). After consent, the answers will be discussed with the doctor during the consultation for appropriate care, including a referral to a psychiatrist and / or addictologist if necessary.

The duration of the inclusions will be 6 months and the number of patients to include is 250.

Eligibility Criteria:
Inclusion Criteria:

* Subject aged over 18,
* Subject seen in consultation in one of the centers of the study for a renewal of the Prep
* Subject having agreed to participate in the study

Exclusion Criteria:

* Subject not speaking French / illiterate
Nitrous TRD Bipolar Depression

Investigators will study approximately 64 patients with Treatment-Resistant Bipolar Depressive Disorder, defined as a failure of at least 1 antidepressants in the current depressive episode and 2 lifetime medication failures. The study will last approximately 6 to 8 weeks, involving randomization into one of two treatment groups receiving 3 one hour long inhalation treatments over a week.

Investigators will study approximately 64 patients with Treatment-Resistant Bipolar Depressive Disorder, defined as a failure of at least 1 antidepressants in the current depressive episode and 2 lifetime medication failures. The study will last approximately 6 to 8 weeks, involving randomization into one of two treatment groups receiving 3 one hour long inhalation treatments over a week. Post-treatment assessments follow each inhalation treatment and are conducted 1 week and 2 weeks following the final inhalation treatment. Patients are then randomized again into the Second Stage of the study, involving the same treatment and post-treatment schedule as the First Stage detailed above.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18-65 years of age
* Treatment-resistant bipolar depressive disorder without psychosis and a MADRS baseline score of \>20. All patients must have history of being on a serum-verified (at time of entry into study) mood stabilizer \[lithium at 0.5-1.2mEq/L; or valproic acid, 50-125mcg/ml\] for 4 weeks prior to entry into the study and remain on this mood stabilizer during the course of the trial. Further, subjects will have failed two adequate dose/duration antidepressant courses in their lifetime, including one in the current depressive episode (verified by Antidepressant Treatment History Form).
* Good command of the English language

Exclusion Criteria:

* Schizophrenia
* Schizoaffective disorder
* Obsessive-compulsive disorder or panic disorder
* Active or recent substance abuse or dependence (in remission at least 1 year prior to the study; exception = nicotine use disorders)
* A diagnosis of personality disorder that may interfere with the patient's ability to improve on nitrous oxide as determined by study investigator
* Acute medical illness that may pose subject at risk during nitrous oxide administration (neurological disorders or medical disorders including dementia, stroke, encephalopathy, Parkinson's Disease, brain tumors, multiple sclerosis, seizure disorder, severe cardiac disease, any disease known to affect drug metabolism and excretion, i.e. renal or liver disease) per P.I. discretion
* Active suicidal intention (inability to contract for safety)
* Active psychotic symptoms
* Patients with significant pulmonary disease and/or requiring supplemental oxygen
* Contraindication against the use of nitrous oxide: pneumothorax; bowel obstruction; middle ear occlusion; elevated intracranial pressure; chronic cobalamin and/or folate deficiency treated with folic acid or vitamin B12; pregnant patients; breastfeeding women; previous administration of NMDA-receptor antagonists (e.g., ketamine); current electro-convulsive therapy treatment
Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Patients With Meniere's Disease

* This prospective study aims to better characterize inner ear's perilymphatic structures with Magnetic Resonance Imaging using contrast media and delayed injection in patient's with Meniere's disease.
* MR Perfusion Imaging will be assess in both cochlea as well
* Primary auditory brain pathways will be evaluated through MR diffusion imaging


Eligibility Criteria:
Inclusion Criteria:

* Major subjects of over 40 years (mean age of Meniere's disease 40 to 50 years)
* Informed consent signed
* Medical examination performed prior to participation in research
* Patients with clinical criteria of Meniere's disease according to the classification of the American Association of Otology (ie the combination of a sensorineural hearing loss at low frequencies, recurrent vertigo and tinnitus and / or clogged ear sensation)
* Recipient of a French social security scheme

Exclusion Criteria:

* Patients minors
* Patients on a legal protection regime type guardianship
* Respiratory pathologies, cardiovascular, renal, diabetes
* Claustrophobia
* Contraindications to exposure to a magnetic field
* Contraindications to injecting Dotarem ®
An Online System to Improve Diabetes Self-Care

The purpose of this study is to see if an online program for patients with diabetes helps patients improve their self-care (how they take their medications, what they eat, how much they exercise, and whether they smoke).

Patient portals are online programs that can provide a number of functions for patients, among them:

* Ability to request appointments, referrals, and medication refills;
* Ability to send secure electronic messages to medical staff, and to receive replies;
* Access to the medical record;
* Disease management

We are comparing two patient portals with different sets of features to determine if personalized information and guidance can improve self-care and measures of diabetes-related health. Self-care measures will be assessed using standardized questionnaires at baseline, 3, and 6 months. Chart review will be used to assess measures of diabetes-related health.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Type 2 diabetes mellitus
* Has access to Internet
* Has e-mail address
* Established patient at one of four participating practices at University of Colorado Hospital

Exclusion Criteria:

* Non-English speaking
A Test of Nutritional Interventions to Enhance Weight Loss Maintenance

The purpose of this study is to compare standard Behavior Therapy (BT), BT plus Meal Replacements (MR) and a condition focusing on the nutritional changes to the home food environment (HFE) on weight loss, weight loss maintenance, nutritional composition of the diet and psychosocial outcomes. A second aim is to determine the degree to which the specific targets of the experimental interventions do in fact change in the anticipated direction during the intervention and to evaluate whether such changes might account for improvements in weight loss maintenance. This study is important because it could provide the first evidence that the current standard of care for obesity lifestyle treatment could be improved by the addition of MRs or a program of comprehensive nutritional change.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants between the ages of 18 and 65
* body mass index (BMI; kg/m2) between 27-45
* able to travel regularly to the study location
* interested in participating in a weight loss program.

Exclusion Criteria:

* currently enrolled in another organized weight loss program
* lactose intolerance
* taking medications that affect appetite (unless dosage had been stable for at least the previous six months)
* history of gastric bypass or other surgical weight loss procedures
* medical conditions (e.g., cancer, substance abuse, psychotic disorders) that could limit their ability to comply with the behavioral recommendations or pose a risk to the participant during weight loss
* pregnancy or planning to become pregnant during the next two years -
* breastfeeding
* consuming an amount of alcohol that could interfere with study completion