cyrilzakka/clinical-trials huggingface dataset:
Validation of a Remote Wireless Sensor Network (WSN) Approach to the Individualized Detection of Cocaine Use in Humans

This study looks to explore the feasibility, sensitivity, validity, and specificity of a Remote Wireless Sensor Network (RWSN) approach to the detection of cocaine use/intoxication in the inpatient human laboratory, as well as in the outpatient setting ("real world"). Lastly, we look to design an algorithm for reliably detecting cocaine use in real-world settings and inference techniques for understanding the relationship between cocaine use and user contexts.


Eligibility Criteria:
Inclusion Criteria:

1. age 18 - 50 years,
2. voluntary, written, informed consent,
3. physically healthy by medical history, physical, neurological, ECG, and laboratory examinations,
4. DSM-IV criteria for Cocaine Abuse (305.60) or Cocaine Dependence (304.20)
5. recent street cocaine use in excess of amounts to be administered in the current study,
6. intravenous and/or smoked (crack/ freebase) use,
7. positive urine toxicology screen for cocaine,
8. for females, non-lactating, no longer of child-bearing potential (or agree to practice effective contraception during the study), and a negative serum pregnancy (β-HCG) test.

Exclusion Criteria:

1. Other drug dependence (except nicotine) as determined by urine toxicology or interview
2. \< 1 year of cocaine dependence,
3. a primary major DSM-IV psychiatric diagnosis (schizophrenia, bipolar disorder, etc.), unrelated to cocaine,
4. a history of significant medical (cardiovascular) or neurological illness, ie prior myocardial infarction, current active symptoms of cardiovascular disease / angina, evidence of cocaine-related cardiovascular symptoms, prior arrhythmias or need for cardiov ascular resuscitation, neurovascular events such as transient ischemic attacks, stroke, and/or seizures Parameters re: elevations in vital signs are now explicitly specified under "Safety features built into our one-day self-administration paradigm).
5. current use of psychotropic and/or potentially psychoactive prescription medication,
6. seeking treatment for drug abuse/dependence (for experimental cocaine component),
7. physical or laboratory (β-HCG) evidence of pregnancy.
8. current use of any medication (prescription or over-the-counter) determined to cause potential drug interactions by the study physicians.
A Safety Study Of Pregabalin In Fibromyalgia

To evaluate the safety of pregabalin in patients with fibromyalgia.


Eligibility Criteria:
Inclusion Criteria:

* Patients must meet the ACR criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites.
* Patients must complete the double-blind study.

Exclusion Criteria:

* Patients who experienced a serious adverse event during the previous fibromyalgia study, which was determined to be related to the study medication.
Reflexology for Chronic Constipation

The purpose of this study is to examine if the use of reflexology can alleviate chronic constipation. The trial will last 26 week per patient, 2 week of screening period, 12 weeks of treatment and 12 weeks of follow up. Included in the study will be 40 men and women, 18 years of age or older, which are able to comply with the study guidelines; Fewer than three spontaneous bowel movement per week; and one or more of the following symptoms/signs during more than 25% of bowel movements for at least 12 weeks within the preceding 12 months: (1) straining, lumpy or (2) hard stools, and (3) a sensation of incomplete evacuation. Exclusion criteria are: Loose or watery stool in the absence of laxative use for more than 25% of bowel movements during the 12 weeks preceding the trials; Mushy stool defined as a score of 6 on the Bristol Stool Form Scale for any SBM during the baseline period; Rome III criteria for the irritable bowel syndrome; History of pelvic-floor dysfunction; Neurological pathologies; Psychiatric conditions; Chronic use of medication with a gastro intestinal-activity.


Eligibility Criteria:
Inclusion Criteria:

* Age of 18-55 years
* Fewer than three SBMs per week (occurring without the use of a laxative, enema, or suppository within the preceding 24 hours)
* One or more of the following symptoms/signs during more than 25% of bowel movements for at least 12 weeks within the preceding 12 months:(1)straining, lumpy or (2) hard stools, and (3)a sensation of incomplete evacuation Six or fewer SBMs/week and fewer than three complete CSBMs/week during the 14-day baseline period.
* Ability to comply with the study guidelines

Exclusion Criteria:

* Loose or watery stool in the absence of laxative use for more than 25% of bowel movements during the 12 weeks preceding the trials.
* Mushy stool defined as a score of 6 on the Bristol Stool Form Scale for any SBM during the baseline period.
* Rome III criteria for the irritable bowel syndrome.
* History of pelvic-floor dysfunction.
* Neurological pathologies
* Psychiatric conditions
* Chronic use of medication with a GI-activity.
Elderly Demented Patients: Aromatherapy Complementary to Psychopharmacotherapy Psychological Disorders and BPSD Behavior

Behavioral and psycological symptoms of dementia, (BPSD) are one of the major problem for families, doctors and for patients the same. To reduce the side effects of the standard treatments, is important to find an alternative methods of treatment, eg the aromatherapy. There is an incresing in scientific evidence the its use in dementia behavior related.

Behavioral and psycological symptoms of dementia, (BPSD) are one of the major problem for families, doctors and for patients the same.

In absence of the universally recognized guidelines, the standard treatment involves the use of psychotropic drugs (typical / atypical neuroleptics, antidepressants, benzodiazepines) that are often not very effective and involve a series of side effects such as sedation, slowing down -motor with impaired cognitive performance, cardiac electrical changes and extrapyramidal syndrome. In view of this, it is important to find an alternative methods of treatment, which can reduce psychological and behavioral disorders and at the same time the use of psychotropic drugs.

As for aromatherapy, ie the therapeutic use of natural essential oils, there is a decades-long clinical experience, especially in France, which is accompanied by increasing scientific evidence with considerable increase in publications in its use in psychological disorders and dementia behavior related. Based on the scientific publications available, it was therefore decided to use two essential oils (Citrus sinensis, Lavandula angustifolia) in environmental diffusion in the Geriatric Department of the Clinica Luganese Moncucco.

Eligibility Criteria:
Inclusion Criteria:

* patients admitted to the acute geriatric ward;
* patients with a known diagnosis of dementia associated with BPSD or diagnosis performed during hospitalization.

Exclusion Criteria:

* patients with alcohol-based dementia;
* patients with Mild Cognitive Impairment (MCI) - section 4 -;
* patients with language barrier;
* patients already being treated with aromatherapy.
Gamification in the Treatment of Spider Phobia

Mobile applications are more and more considered when implementing programs for treating mental disorders. The study aims to reduce avoidance and fear of spiders in spider-fearful individuals by combining exposure principles with gamification elements (e.g. narrative background, level progression, points, feedback). We investigate the efficacy of the gamified app in a remote online-therapy context.


Eligibility Criteria:
Inclusion Criteria:

Participants must

* be 18 years or older,
* SPQ score ≥ 14
* BDI-II score ≤ 18

Exclusion Criteria:

Participants will be deemed ineligible if they do not meet the above inclusion criteria or

* are allergic to spiders or bee stings,
* are currently undergoing psychotherapeutic and/or psychopharmacological treatments,
* are experiencing current psychosis, mania, or substance abuse, or
* successfully complete 8 or more of 12 possible BAT steps at baseline (to ensure that participants are indeed spider fearful)
* are at higher risk from Covid-19 or
* participated in a pilot study in 2019.
Effects of High-dose Intravenous Selenium (Selenase®) in Adult Patients Subjected to Elective All-cause Heart Surgery

Selenoenzymes play a major role in protecting cells against lipid peroxidation and they are involved in the inflammatory response regulation. The degree of selenium deficiency correlates with disease severity and the incidence of mortality in critically ill patients. The aim of our study is to evaluate, if high dosis selenium supplementation (loading dose 4000 μg, daily dosage 1000 μg) results in a significant reduction of inflammation-induced organ dysfunction and length of ICU-stay in patients after heart surgery.

Selenium is a essential micronutrient that is present in form of selenocysteine in many enzymes. Selenoenzymes play a major role in protecting cells against lipid peroxidation and they are involved in the inflammatory response regulation. The degree of selenium deficiency correlates with disease severity and the incidence of mortality. Different studies showed that selenium supplementation had beneficial effects in critically ill patients with systemic inflammatory response syndrome (SIRS), reducing the rate of infectious complications and length of hospital stay.

Heart surgery is associated with a complex systemic inflammatory response and the extent correlates with the development of postoperative complications. Former clinical trials used selenium supplementation with a loading dose of normally 1000 to 2000 μg, followed by a daily dosage of 1000 μg. With these dosage regimes pharmacological investigations demonstrated a delayed increase of the selenium concentration in plasma and whole blood. As a result a delayed increase of selenoenzymes can be assumed.

Aim of our study is to evaluate, if high dosis selenium supplementation (loading dose 4000 μg, daily dosage 1000 μg) results in a significant reduction of inflammation-induced organ dysfunction and length of ICU-stay in patients after heart surgery.

Primary endpoints are: Clinical outcome quantified by using the Sequential Organ Failure Assessment (SOFA) Score and the length of ICU stay in hours.

Secondary endpoints are: incidence of acute renal failure, total requirement of vasoconstrictors and fluid replacement therapy

Inclusion criteria: written informed consent, males and females age ≥ 18 years, patients undergoing an elective heart surgery, normal renal function (serum creatinine ≤ 200 μmol/l)

Exclusion criteria: pregnancy, lack of written concent, emergency operation

Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* males and females age ≥ 18 years
* patients undergoing an elective heart surgery
* normal renal function (serum creatinine ≤ 200 μmol/l)

Exclusion Criteria:

* pregnancy
* lack of written concent
* emergency operation
A Study for Participants With Small-Cell Lung Cancer

Part A: This study evaluates an experimental treatment in participants with extensive-disease in small-cell lung cancer.

Part B: This study evaluates an experimental treatment in participants with extensive-disease in small-cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Have histological or cytological evidence of extensive-disease small-cell lung cancer
* Have the presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
* Have received at least 1 prior chemotherapy regimen with agents known to provide clinical benefit for small-cell lung cancer and be, in the opinion of the investigator, an appropriate candidate for experimental therapy
* Have discontinued all previous therapies for cancer, including chemotherapy, biologic therapy, hormone therapy, or radiotherapy. Participants must have recovered from the acute effects of therapy (except alopecia and fatigue) before study enrollment
* Part A: Have a performance status of 0 to 2 on the Eastern Cooperative Oncology Group scale
* Part B: Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group scale

Exclusion Criteria:

* Have received treatment within 28 days of the first dose of LY2523355 with a drug that has not received regulatory approval for any indication
* Have a mixed histological diagnosis of small-cell lung cancer and non-small-cell lung cancer
* Have serious preexisting medical conditions that, in the opinion of the investigator, would preclude participation in this study
* Part A: Have symptomatic, untreated, or uncontrolled central nervous system (CNS) metastases. Participants with treated CNS metastases are eligible provided their disease is radiographically stable, asymptomatic, and corticosteroid use has been discontinued for at least 2 weeks prior to the first dose of study drug. Screening of asymptomatic participants without history of CNS metastases is not required
* Part B: Have symptomatic, untreated, or uncontrolled CNS metastases or a history of CNS metastases. Participants who have received prophylactic radiation are not excluded. Screening of asymptomatic participants without history of CNS metastases is not required
Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children From 8 to 12 Years Old in Dakahlia

The aim of this study is to assess the prevalence of MIH among a group of Egyptian children aged from 8-12 years old in Dakahlia governorate schools.

* Clinical examination will be carried out in the school laboratory or an empty class, in day light, teeth will be cleaned gently using gauze and wet with saliva during examination. A disposable diagnostic set (mirror, probe) will be used for each patient where mirrors will be used for proper visualization especially for maxillary teeth. Blunt explorers will be used to aid in tactile sensation if needed, as during the differentiation between rough and smooth enamel edges and/or during the inspection of the caries extent if it exists. No diagnostic radiographs will be taken.
* An examination chart (Appendix 1) will be filled for each child including: date, name, age, address, gender, school, medical health and any previous dental treatment, followed by clinical examination to the four first permanent molars and the eight maxillary and mandibular incisors to detect the presence of MIH and its severity based on European Academy of Pediatric Dentistry (EAPD) criteria . To diagnose Molar Incisor Hypomineralization, at least one affected first permanent molar is required. Extracted first permanent molar will be recorded as affected if another first permanent molar has a defecting MIH
* Each child affected with MIH will be given a letter outlining his dental health status, to inform the parents and indicate the need for treatment.

Examination chart

Date:

Personal information:

Name: Age: Gender:

Address:

School:

Medical history:

Dental history:

Clinical examination:

8 7 6 5 4 3 2 1 1 2 3 4 5 6 7 8

8 7 6 5 4 3 2 1 1 2 3 4 5 6 7 8

Severity according to EAPD:

Code Description Severity 0 No defect

1. White or creamy demarcated opacities/mild Mild
2. Yellow or brown demarcated opacities Mild
3. a Enamel loss Moderate

3b Enamel and dentin loss Severe 3c Atypical large cavities extended to pulp and covering one or more tubercle Severe 4 Atypical restorations Severe 5 Extracted tooth Severe

Comments:

MIH: presence / absence Severity: Mild / Moderate /Severe

(Appendix 1)

Eligibility Criteria:
Inclusion Criteria:

* Acceptance for participation in the study.
* Children aged from 8-12 years old.
* Eruption of at four first permanent molars.
* Both genders.

Exclusion Criteria:

* Uncooperative children.
* Children with orthodontic appliances.
* Children with systemic diseases which may affect teeth development.
* Children suffering from any other type of enamel defect as enamel hypoplasia and amelogenesis imperfecta.
Dexmedetomidine Sedation in Children With Respiratory Morbidities

This study aimed to determine the feasibility of dexmedetomidine in children with respiratory morbidities who required deep sedation for magnetic resonance imaging (MRI) scans.

Electronic medical records of children with at least 3 characteristics of respiratory morbidities were retrospectively reviewed. All study patients received dexmedetomidine bolus over 10 min followed by a continuous infusion to achieve a minimum Ramsay Sedation Score of 5. Patients were monitored for hemodynamics, total dose of dexmedetomidine received, adverse events experienced and sedation characteristics.

Eligibility Criteria:
Inclusion Criteria:

* Children up to the age of 16 years with at least 3 characteristics of respiratory morbidities

Exclusion Criteria:

* Children who had an American Society of Anaesthesiologists (ASA) physical status classification IV
* Documented pre-existing cardiac conduction abnormalities
* Renal impairment
Safety and Efficacy of Conivaptan in Hyponatremic Patients With Symptomatic Acute Decompensated Heart Failure (ADHF)

This study will evaluate the safety and effectiveness of Conivaptan, a vasopressin antagonist, in the treatment of hyponatremic subjects having symptomatic acute decompensated heart failure (ADHF).

Subjects will be recruited from the Emergency Department. It is expected that subjects will be treated according to the institution's accepted conventional therapy protocol for the treatment of ADHF. Therapy may also include the use of loop diuretics for the relief of pulmonary congestion and maintenance of adequate urine output.

Eligibility Criteria:
Inclusion Criteria:

* Presents to emergency department with documented history of CHF and symptomatic ADHF, will be treated for ADHF, and primary reason for admission to the hospital is ADHF
* Dyspnea at rest or with minimal exertion and must have moderate shortness of breath (SOB) in any of the first three Provocative Dyspnea Assessment positions
* Severe pulmonary congestion as evidenced by jugular venous distention or lower extremity/sacral edema or rales upon chest auscultation or chest x-ray.
* BNP \> 400 or NT-pro BNP \> 1500 drawn during Screening
* Systolic blood pressure \>= 100 mmHg to \< 180 mmHg at time of start of study drug
* Serum sodium value \>= 115 mEq/L (115 mmol/L) and \< 135 mEq/L (135 mmol/L) during Screening

Exclusion Criteria:

* Clinical evidence of volume depletion
* Active ongoing acute coronary syndrome or acute ST segment elevation myocardial infarction (or has experienced a myocardial infarction within 30 days of Screening)
* In cardiogenic shock
* Calculated creatinine clearance \< 30 mL/min/1.73 m2 as estimated by the Modification of Diet in Renal Disease (MDRD) equation, has received intravenous (IV) contrast agent within 72 hours prior to randomization or is expected to receive IV contrast agent within the first 72 hours of study participation
* Ultrafiltration within the past 72 hours.
* Currently using or expected to use inotropic therapy
* Cardiac bypass grafts in the past 60 days
* Cerebrovascular accident in the past 30 days
* Uncontrolled brady- or ventricular tachyarrhythmias requiring emergent pacemaker placement or treatment
* Hemodynamically significant uncorrected primary cardiac valvular disease or hypertrophic cardiomyopathy
* Untreated severe hypothyroidism, hyperthyroidism or adrenal insufficiency based on medical history
* ALT or AST elevations \> 5 times upper limit of normal
* Biliary liver cirrhosis, history or presence of severe hepatic encephalopathy, ascites, esophageal variceal bleeding within the past three months, severe portal hypertension or surgical portosystemic shunt.
* Received any organ transplant, clinical diagnosis of pneumonia, symptomatic hyponatremia requiring urgent intervention or any concurrent illness which, in the opinion of the investigator, may interfere with treatment or evaluation of safety
* Pregnant or lactating
* Currently using vasopressin, oxytocin or desmopressin
Assessing Moral Cognitive Skills in Adults With Autism Spectrum Disorders

In the international literature, it is currently accepted that, relative to neurotypicals, people with Autism Spectrum Disorder (ASD) present patterns of moral judgments marked by a minimization of intentionality and a strong condemnation of agents responsible for accidents. However, until now, all studies are based on declarative paradigms, and no one has proposed to examine the relationship of people with ASD to moral transgressions (i.e. to a bad action done deliberately or to a good deed deliberately omitted) in an implicit paradigm, that is, when the answer is made on the assignment of an expressive face to these moral offenses. Furthermore, no study has investigated whether diminished sensitivity to intention and intransigence of incidental judgment occur in both automatic (implicit) and deliberative (explicit) settings.

Investigators planned to study how people with ASD without intellectual disability process emotions expressed by others in response to different forms of moral offense and to examine whether patterns potentially contrast in degree and/or kind with those of neurotypicals.

In the CoMorA project, participants will participate to two independent tasks: an explicit one of deciding whether or not an emotion expressed on the face of a third person would be an appropriate emotional reaction to the offense, and an implicit one in which the subjects will have to determine the fastest sex to which the face expressing such or such an emotion belongs. This procedure initiates an implicit processing of the facial expression.

The theoretical hypotheses of the CoMorA project are the following:

* In the explicit response condition, people with ASD will show different emotional assignment patterns than controls do, depending on the nature of the offense (accidental transgression, attempted harm, and intentional harm).
* In the implicit response condition, people with ASD will exhibit emotion processing patterns identical to those of controls.
* The differences in responses of controls and people with ASD in the explicit condition will be underpinned by executive functions and social cognitive performances.

Eligibility Criteria:
Inclusion Criteria:

ASD group:

* Diagnosis of ASD according to DSM-5 criteria
* Age between 18 and 40 years old
* Francophone
* Affiliated to social security
* Having given their consent to participate in the study
* Patient under guardianship and curatorship

Neurotypical group:

* Age between 18 and 40 years old
* Francophone
* Affiliated to a social security scheme
* Having given their consent to participate in the study

Exclusion Criteria:

ASD group:

* Diagnosis of intellectual development disorder established according to DSM-5 criteria
* Language, sensory or motor impairments hindering participation in the study

Control group:

* Neurodevelopmental pathology (declarative)
* Neurological pathology
* Language, sensory or motor impairments hindering participation in the study