cyrilzakka/clinical-trials huggingface dataset:
Deep Brain Therapy With Low-intensity Ultrasound for Generalized Chronic Pain

This study will evaluate a new form of non-invasive deep brain therapy for individuals with generalized chronic pain. Low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitoring. A well-tolerated stimulation protocol will be selected for subsequent testing in a blinded randomized sham-controlled cross-over trial. The trial will evaluate brain target engagement using magnetic resonance imaging and CVAS and PROMIS numerical rating scales of pain.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65, any gender
2. Primary diagnosis of generalized chronic pain or widespread chronic pain.
3. Moderate-to-severe chronic pain lasting at least 2 months
4. Stated willingness to comply with all study procedures and avoid changes to current treatments (medications, physical therapy, cognitive behavioral therapy) for the duration of the study
5. For females of reproductive potential: negative pregnancy test or use of highly effective contraception for at least 1 month prior to baseline; agreement to use such a method throughout the study
6. Capacity to provide informed consent; provision of a signed and dated consent form

Exclusion Criteria:

1. History of serious brain injury or other neurologic disorder
2. Poorly managed general medical condition
3. Pregnant or breast feeding
4. Implanted device in the head or neck
5. MRI intolerance or contraindication
6. Brain stimulation (e.g., VNS, TMS) in the past month
7. Lifetime history of a serious suicide attempt (Hooley et al., 2014)
8. Clinically inappropriate for participation in the study as determined by the study team
Maxillary Sinus Floor Augmentation With Bioss® and Enamel Matrix Derivative: Evaluation of Osteogenic Properties

The main problem of using xenogenic bone in sinus floor elevation is the slow rate of absorption, which gives the percentages of vital bone low (20 to 30% depending on the study) in which the dental implant will be positioned However, osseointegration of the implant can be achieved only in vital bone. Enamel Matrix Derivative, through their angiogenic and osteogenic properties known, could promote bone healing during surgery sinus floor elevation by increasing the percentage of vital bone reformed, when added to xenografts.


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 45 years, postmenopausal women (ie with amenorrhea for more than a year).
* Subject requiring bilateral sinus floor elevation, in order to place two implants in grafted side.
* patients smoking less than 10 cigarettes per day
* patients having read and understood the information note on the study and signed the informed consent form.
* patients affiliated to the social security system.

Exclusion Criteria:

* Patient with absolute contra-indication for dental surgery: valvular heart disease at risk of infectious endocarditis, recent myocardal (≤ 12 months), organ transplants, recent placement of a coronary stent (≤ 12 months), transient ischemic attacks recurrent, cardiovascular instability, uncontrolled epilepsy, rheumatic fever.
* Patient with metabolic bone disease (Paget's disease, osteomalacia, osteogenesis imperfecta)
* Patient with an ASA score ≥ 3.
* Patient with absolute contra-indication to dental surgery
* Patient with severe hematologic disease
* Patient with I or type II diabetes
* Patients with previous or current acute illness or severe chronic cardiovascular, renal, hepatic, gastrointestinal, allergic, endocrine, neuro-psychiatric, considered by the investigator to be incompatible with the conduct of the study.
* Patients treated with retinoids, oral bisphosphonates, oral anticoagulants or anticonvulsants.
* Patient have or have had cancer of the upper aerodigestive tract treated by radiotherapy.
* Patient taking a steroidal or non-steroidal anti-inflammatory, anti-cancer or immunosuppressive chemotherapy in the last 6 months.
* Patient monitoring considered difficult by the investigator.
* Patient with poor oral hygiene incompatible with oral surgery.
* Patients with periodontal disease unstabilized
* Patient with oral dermatitis or adverse occlusion.
* Patient with an acute or chronic infection of the surgical site (osteomyelitis).
* Patient with a known allergy to collagen
* Patient with autoimmune disease
* Patient with a linguistic or mental incapacity to understand information
* Patient younger than 45 years old
* Patient trust under curatorship or judicial protection
* Patients aged over 45 premenopausal.
* Patient participating in another clinical study.
Investigational Air-Activated Adhesive-Backed Heat Patch (3-Cell)

This is an open-label study. A total of approximately 60 subjects will be randomly assigned to receive either the heat patch (30 subjects) with a temperature probe/skin reference probe or a heat patch (30 subjects) alone. The study will consist of 2 visits.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who complete an appropriately administered informed consent process that includes signing the consent form.
* Subjects 18-75 years old of either sex.
* Are of any skin type or race, providing the skin pigmentation will allow discernment of erythema;
* Subjects who are in good general health.
* Subjects who are willing and able to have the test products applied as directed, and comply with study instructions.
* Participants must be willing to restrict their activity for the 8 hour patch wear time.
* All participants agree to wear a t-shirt provided by the site for the entire 8 hour patch wear time.

Exclusion Criteria:

* Subjects who have a history of sensitivity to any of the test products or adhesion material.
* Subjects who are pregnant.
* Subject with excessive hair at the application sites, scar tissue, tattoo, or coloration that would interfere with placement of test product or skin assessment.
* Subjects with diabetes, rheumatoid arthritis, poor circulation or have any clinically significant chronic illness.
* Subjects with active dermatitis (including sunburn) in the treatment area, or other visible dermatological disease which, in the investigator's opinion, might interfere with the response to the test products or interfere with the skin assessments associated with the test products.
* Have history of significant dermatologic cancers (eg, melanoma, squamous cell carcinoma).
* Subjects who have used topical dermatological products in the application area within 24 hours prior to the test product application.
* Subject using a concomitant medication that, in the investigator's opinion, could interfere with the interpretation of study results. Examples of such drugs include non-steroidal anti-inflammatory drugs (NSAIDs, e.g., aspirin), topical or systemic corticosteroids, and cold/cough products containing antihistamines and/or either phentolamine, pseudoephedrine or phenylpropanolamine.
* Subjects who have received an investigational medication or device within 30 days prior to enrolment into this study.
* Subjects who are currently participating in an investigational study.
* Subject who are known to be noncompliant or are unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.
Effects of Beverage Volume, Glycerol Concentration, and Sodium Concentration on Fluid Balance in Healthy Euhydrated Men and Women at Rest

The presence of certain ingredients such as sodium and glycerol can facilitate retention of the fluid consumed via renal water reabsorption. To maintain overall whole-body fluid balance, it is important that ingested fluid is retained in the body instead of losing it through urination.

The purpose of this study is to determine the effect of sodium and glycerol concentrations at various fluid intake volumes on fluid balance in healthy, euhydrated men and women.


Eligibility Criteria:
Inclusion Criteria:

* Subject is male or female
* If female, subject is not pregnant
* Subject is 18-50 years of age, inclusive
* Subject is at least recreationally active (engaged in light to moderate-intensity, intermittent, or steady-state exercise at least 3 days per week for at least 30 min at a time)
* Subject does not smoke (or has quit for at least 6 months)
* Subject is not taking medication that may interfere with the study (e.g., diuretics)
* Subject has no health conditions that would interfere with the study (e.g. cardiovascular, renal, or metabolic diseases)
* Subject is willing to avoid alcohol consumption 24 hours prior to visit(s)
* Subject is willing to fast overnight (\~8-12 hours)
* Subject is willing to refrain from vigorous exercise for 24 hours
* Subject is willing to eat the exact same food the day prior to each visit to the laboratory
* Provision of written consent to participate

Exclusion Criteria:

* Subject has participated in a clinical trial within the past 30 days
* Subject has participated in any PepsiCo trial within past 6 months
* Subject has a condition or is taking medication that the investigator believes would interfere with his/her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the person at undue risk
* Subject is employed by, or has a parent, guardian, or other immediate family member employed by a company that manufactures any products that compete with any Gatorade product. If subject is unsure if a company would be considered a competitor to Gatorade, they will be asked to please let the study investigator know the name of the other company and the nature of their relationship to that company before they sign the informed consent.
A Multi-site Intervention to Expand Hospital Based OUD Treatment Provision

The investigators implemented a multi-site hospital-based opioid use disorder (OUD) treatment intervention across 12 hospitals in Colorado to address an OUD treatment gap among hospitalized adults with OUD.

The investigators implemented a multi-site hospital-based opioid use disorder (OUD) treatment intervention across 12 hospitals in Colorado to address an OUD treatment gap among hospitalized adults with OUD. The intervention included nurse driven universal screening for unhealthy substance use with a social work referral for a brief intervention when indicted, electronic health record-embedded protocols to assess for opioid withdrawal and to direct buprenorphine initiation, methadone orders for opioid withdrawal symptoms, and embedded links for post discharge addiction treatment referral. It also included clinician education and nursing education via video conference or in-person lectures. The intervention was supported by the health system Chief Medical Officer and involved subject matters expertise and representation from nursing leaders, social work leaders, and hospital medicine leaders. Outcomes assess include a pre/post implementation assessment of 1) change in buprenorphine prescribed in hospital and 2) discharge, 3) change in naloxone prescribed, 4) change in hospital based methadone prescribing, and 5) change in average clinical opioid withdrawal scale (COWS) score. investigators also assessed a pre/post survey of hospitalists physicians and advanced practice providers to assess their perception of hospital based OUD treatment provision.

Eligibility Criteria:
Inclusion Criteria:

* Physicians, advanced practice providers, social workers, and nurses who work at any affiliated hospitals

Exclusion Criteria:

* none
Evaluation of Re-Entry Values and Mindfulness Program (REVAMP) With Jail Inmates

This is a pilot study to examine the acceptability and effectiveness of the Re-Entry Values and Mindfulness Program (REVAMP), a group intervention for jail inmates. It is hypothesized that REVAMP will reduce post-release recidivism, substance abuse, and HIV risk behavior.


Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years or older
* Must be male
* Must be currently incarcerated jail inmate
* Must be sentenced
* Sentence must be short enough to serve out sentence at the Adult Detention Center
* Release date must follow projected final session of treatment
* Must speak, read, and write in English with sufficient proficiency to use workbook and participate in group sessions
* Must be assigned to the jail's "general population"

Exclusion Criteria:

* Actively psychotic
* Assigned "keep separate" from other group members
Therapeutic Education in Very Young Children With Diabetes Mellitus

DIAB-EDUC tests in a group of young diabetic patients (less than 6 years old) a specific educational tool in order to assess its impact on glycemic control, quality of life, knowledge about the disease and its daily management, over a period of 2 years. The investigators plan to include 300 type 1 diabetic children in 10 french hospitals.

General frame : 1 inclusion / randomization visit and delivery of the educational tool for patients of the "Therapeutic Education" arm, then follow-up visits every 6 months during 24 months.

V0 - Inclusion / randomization visit - Verification of eligibility - Clinical examination and data report - Blood samples for lab tests (HbA1c assay)- Collection of signed consent form- DIAB-EDUC questionnaire (diabetes knowledge, treatment, quality of life, hypoglycaemia and emergency situations, parental stress)- Randomization - Education tool explanation and delivery by the physicians to parents randomized in " Experimental " arm

M6 - Visit at 6 months- Clinical examination and data report- Blood samples for lab tests (HbA1c assay)

M12 - Visit at 12 months- Clinical examination and data report- Blood samples for lab tests (HbA1c assay)- DIAB-EDUC questionnaire

M18 - Visit at 18 months- Clinical examination and data report- Blood samples for lab tests (HbA1c assay)

M24 - Visit at 24 months- Clinical examination and data report- Blood samples for lab tests (HbA1c assay)- DIAB-EDUC questionnaire

Eligibility Criteria:
Inclusion Criteria:

* Children with type 1 diabetes aged 1 to 6 years
* Disease evolution more than 1 year
* HbA1c \> 8% or at least one acute accident (hypoglycemia or ketosis) during the last year
* Specific information given to parents from the physicians and consent form signed by the parents
* Physical examination of the children at enrolment- patient affiliated with or receiving health insurance

Exclusion Criteria:

* Non-insulin dependent diabetes
* Monogenic diabetes (MODY)
* Severe co-morbidities- cognitive disabilities or psychosocial disadvantage compromising the therapeutic education
* Children whose parents have a disorder of comprehension or expression of the French Language
* Patients included in another interventional trial
Study on Effects of BMS-955176 on the Pharmacokinetics of Probe Substrates

The purpose of the study is to study the effects of BMS-955176 on the single-dose PK parameters of probe substrates caffeine, metoprolol, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin


Eligibility Criteria:
Inclusion Criteria:

1. Written Informed Consent
2. Healthy male and female (not of childbearing potential) subjects as determined by medical history, surgical history, physical examination, vital signs, ECGs, and clinical laboratory determinations
3. Body mass index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening and Day 1. BMI = weight (kg)/\[height(m)\]
4. Women must have documented proof that they are not of childbearing potential (eg, surgically sterile, postmenopausal with a documented follicle-stimulating hormone (FSH) \> 40 mIU/mL) and should not be breast feeding
5. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-955176 in addition to a post-treatment completion period

Exclusion Criteria:

1. Any significant acute or chronic medical illness
2. Use of tobacco, excessive alcohol
3. Medical history indicative of an increased risk of a cardiac arrhythmia or cardiac disease and history of asthma, bronchospasm, sleep apnea, rhabdomyolysis, a bleeding disorder, a major depressive disorder within the past 6 months, peptic ulcer or significant GI bleed, Raynaud's disease, or any gastrointestinal surgery that could impact upon the absorption of study drug
4. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population
5. History of allergy to BMS-955176, digoxin (or any member of the digitalis glycosides class of drugs), caffeine, metoprolol, montelukast, flurbiprofen, omeprazole, midazolam, or pravastatin, or to any related compounds
The Relationship Between Neuropathic Complaints and Central Sensitization in Fibromyalgia

Fibromyalgia (FM) is the prototype of a group of diseases known as central sensitivity syndromes, whose relationship with pain sensitization is well defined. Central sensitization (CS) is also one of the mechanisms involved in the pathophysiology of neuropathic pain. Neuropathic pain, which is a common complaint in FM patients, is likely to be one of the clinical manifestations of central sensitization. Therefore, in this study, it was aimed to investigate the relationship between CS and neuropathic pain.

The term central sensitization (CS) was first used by Wolf in 1988 and explained as an increase in pain sensitivity with the amplification of neuron-derived signals in the central nervous system. Fibromyalgia (FM) is a disease characterized by chronic widespread pain and its etiology and pathophysiology are still unknown. It is considered to be the main member of the CS related disease group known as central sensitivity syndromes with impaired pain regulation. In various studies, hyperalgesia and allodynia, which are accepted as objective findings of CS in pain sensitization. In addition to widespread body pain, neuropathic pain is one of the common symptoms in FM, and various studies have shown a significant increase in neuropathic pain in FM patients compared to healthy controls. It is known that CS is one of the basic mechanisms in the etiopathogenesis of neuropathic pain as well as its role in FM. In a study of FM patients, painDETECT and S-LANSS scores were found to be correlated with CSI scores, and the authors emphasized the relationship between pain sensitization and neuropathic complaints in these patients. CS seems likely to be one of the neuropathic pain mechanisms in FM patients, and the available data seem insufficient to draw a definitive conclusion. From this point of view, in this study, it was aimed to investigate the relationship between the presence and severity of CS and the neuropathic pain component of the disease in patients with FM.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosing fibromyalgia according to ACR 2016 criteria
* Between the ages of 18-65
* Agree to participate in the study

Exclusion Criteria:

* History of concomitant systemic inflammatory disease, active infection and malignancy
* Refusing to participate in the study
* Polyneuropathy, entrapment neuropathy, and radiculopathy are other diagnosed sources of neuropathic pain.
A Study of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Ovary, Peritoneal, or Fallopian Tube Carcinoma

This is a placebo-controlled, randomized, multicenter Phase III study that will evaluate the safety and efficacy of bevacizumab, administered in combination with carboplatin with gemcitabine, in women with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form
* Age ≥ 18 years
* Documented ovarian, primary peritoneal, or fallopian tube carcinoma that has recurred
* No prior chemotherapy in the recurrent setting
* Measurable disease
* Recovered from prior radiation therapy or surgery

Exclusion Criteria:

* Prior chemotherapy treatment for recurrent ovarian, primary peritoneal, or fallopian tube carcinoma
* History of abdominal fistula, gastrointestinal perforation (GIP), or intra-abdominal abscess
* Patients with clinical symptoms or signs of gastrointestinal (GI) obstruction or who require parenteral hydration, parenteral nutrition, or tube feeding
* Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure
* Current, recent, or planned participation in an experimental drug study
* History of systemic bevacizumab (Avastin) or other vascular endothelial growth factor (VEGF) or VEGF receptor-targeted agent use
* Inadequately controlled hypertension
* Prior history of hypertensive crisis or hypertensive encephalopathy
* New York Heart Association Class II or greater congestive heart failure (CHF)
* History of myocardial infarction or unstable angina
* History of stroke or transient ischemic attack (TIA)
* Known central nervous system (CNS) disease except for treated brain metastasis
* Significant vascular disease or recent peripheral arterial thrombosis
* History of hemoptysis
* Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
Physical Activity and Screen-Time Regulations in Childcare Centers - Aim 2

Objective is to examine the physical activity and screen-time behaviors of children enrolled in licensed childcare centers before and after the enactment of new state regulations.

Pause and Play aims to enroll 266 children. Each child will participate in the study for approximately 1 year. Surveys, anthropometric measures, and screen-time observations will take approximately 1 day each to complete, and the child will be given an accelerometer to wear at home for 7 days at both baseline and 1 year follow-up. Fundamental motor skill assessments will take place at baseline and 1 year follow-up after the 7 days of accelerometer wear. Staff members will spend approximately 2 weeks at each childcare center at baseline and 1 year follow-up to complete study procedures with each child.

Eligibility Criteria:
Inclusion Criteria:

* A child who is 3 or 4 years old
* Child spends at least 6 hours per day, 5 days per week at a participating childcare center
* Child will continue to attend the same childcare center for the next year

Exclusion Criteria:

* Parent/legal guardian is unwilling to provide written informed consent