cyrilzakka/clinical-trials huggingface dataset:
Positive Emotions Program for Schizophrenia (PEPS)

This study evaluates the addition of a 8 session psychological program, called Positive Emotions Program for Schizophrenia (PEPS) to improve motivation and pleasure in adults with schizophrenia. Half of the participants will receive their usual treatment and PEPS in combination, while the other half will receive usual treatment only.

Recent literature has distinguished the negative symptoms associated with a diminished capacity to experience (apathy, anhedonia) from those which are associated with a limited capacity for expression (emotional blunting, alogia). The apathy-anhedonia syndrome tends to be associated with a poorer prognosis than the symptoms related to diminished expression, suggesting that it is the more severe facet of the psychopathology. However the efficacy of drug-based treatments and psychological interventions on primary negative symptoms remains limited. There is a clear clinical need for developing treatments for negative symptoms.

The Positive Emotions Programs for Schizophrenia (PEPS) teaches skills to help overcome defeatist thinking and to increase the anticipation and maintenance of positive emotions. PEPS involves eight one-hour group sessions, administered using visual and audio materials as part of a PowerPoint presentation of slides projected onto a screen.

The goal of the study is to establish if PEPS is clinically effective by using a randomized, controlled and assessor-blind trial. A combination of PEPS plus treatment as usual will be compared to treatment as usual alone. Participants diagnosed with a schizophrenia spectrum disorder will undergo either intervention for eight weeks. Testing will evaluate individuals' current psychopathology and ability to savor pleasure and will be performed at the time of inclusion, at the end of the eight-week intervention and at six month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* a psychotic disorder according to ICD 10 (F20 or F25), diagnoses having been established by experienced clinicians;
* presenting a score of at least 2 on the overall SANS anhedonia scale;
* French-speaking;
* Ability to consent measured with the San Diego Brief Assessment of Capacity to Consent (UBACC)-a decisional capacity instrument.

Exclusion Criteria:

* evidence of organic brain disease, clinically significant concurrent medical ill/ness, or learning disability;
* no understanding of the study protocol as assessed with the San Diego Brief Assessment of Capacity to Consent (UBACC)-a decisional capacity instrument
Vitamin D and Cardiovascular Events in Rheumatoid Arthritis

The aim of the study is to evaluate cardiovascular events during long-term follow-up in Rheumatoid Arthritis. The primary outcome "any cardiovascular event" will be evaluated using systematic audits of patient records, and will be associated to low levels of vitamin D at baseline, to investigate the hypothesis that low levels of vitamin D can be part of a prediction model for cardiovascular disease in Rheumatoid Arthritis.

Cardiovascular morbidity and mortality is increased in patients with rheumatoid arthritis (RA), and among these patients, the prevalence of hypo-vitaminosis D is high. Low levels of vitamin D have been associated with elevated cardiovascular risk in healthy subjects. The objective of this study is to evaluate the risk of cardiovascular events in patients having low 25OHD-total levels at baseline compared to patients with sufficient levels, in an aggressively treated closed cohort of early-diagnosed RA patients.

The primary outcome will be the proportion of patients with any cardiovascular event, evaluated using systematic journal audits. Logistic regression models will be applied to test the hypothesis that there are more cardiovascular events in patients enrolled with a low level of vitamin D (\< 50 nmol/l). Secondarily, Cox regression models, based on survival analysis, will be applied, to determine the extent to which independent variables (including different levels of vitamin D at baseline) predict not only whether a cardiovascular event occur, but also when it will occur.

Eligibility Criteria:
Inclusion Criteria: Fulfilling ACR1987 (American College of Rheumatology 1987 classification criteria for Rheumatoid Arthritis) criteria for RA, disease duration \< 6 months, 2 or more swollen joints and age between 18 and 75 years -

Exclusion Criteria: Glucocorticoid treatment 4 weeks prior to inclusion, previous use of DMARDs, malignancy, diastolic blood pressure \> 90 mm Hg, elevated serum creatinine, infections with parvovirus B19, Hepatitis B, C and HIV, and any condition contraindicating the study medication.

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Stereotactic Radiosurgery (SRS) in Malignant Spasticity and Hypertonia

This is a pilot, experimental, monocentric study. The main objective of the study is to evaluate whether stereotactic radiotherapy is able to reduce symptomatic spasticity from a clinical point of view, and therefore induce an improvement in posture and quality of life in patients with malignant spasticity.

The study foresees the enrollment of about 10 patients, in a period of 24 months. The radiotherapy treatment will be delivered in a single session with an image-guided stereotaxic technique, and a prescription dose between 45 and 60 Gy; subsequently the patients will be followed up for one year.


Eligibility Criteria:
Inclusion Criteria:

* Malignant spasticity measured with the Modified Ashworth Scale (MAS≥3) or highly impairing spasticity and hypertonia (Numeric Rating Scale \>8 scored by patient or care-giver)
* Age ≥ 18 years old
* Availability of a diagnostic MR scan of the spine segment of interest and electromyography of inferior limbs within 3 months prior to study entry
* Previous ineffective conventional treatment for spasticity or absence of others therapeutic strategies (i.e. negative baclofen pump test, comorbidity limiting the pump implant as spondylodiscitis or severe obesity)
* Plegic patients or minimally conscious state patient
* Signed informed consent (in case of minimally conscious state patients, consent form will be signed by her / his legal representative)

Exclusion Criteria:

* Age \< 18 years old
* Previous radiation in the same anatomical site
A Study of TRV130 for the Treatment of Pain After Bunionectomy

The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain after bunionectomy.

The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain after bunionectomy. The results section also includes data from the morphine arms.

Eligibility Criteria:
Inclusion Criteria:

* Has undergone primary, unilateral, first metatarsal bunionectomy (osteotomy and internal fixation) with no additional collateral procedures.
* Experiences a pain intensity rating of ≥ 4 on an 11 point NRS
* Able to provide written informed consent before any study procedure.

Exclusion Criteria:

* ASA Physical Status Classification System classification of P3 or worse
* Has surgical or post-surgical complications.
* Has clinically significant medical conditions or history of such conditions that may interfere with the interpretation of efficacy, safety, or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of drugs.
* Has previously participated in another TRV130 clinical study.
A Study Evaluating Drug Drug Interaction Between Milvexian and Atorvastatin in Healthy Participants

The purpose of this study is to evaluate the potential pharmacokinetics (PK) interaction between milvexian and atorvastatin (and its metabolites) in healthy participants at steady state.


Eligibility Criteria:
Inclusion Criteria:

* Healthy on the basis of physical examination, medical history, vital signs, Electrocardiogram (ECG), and laboratory test results, including serum chemistry, blood coagulation, hematology, and urinalysis, performed at screening.
* Normal renal function at screening as evidenced by an estimated glomerular filtration rate (eGFR) of greater than or equal to (\>=) 90 milliliter per minute per 1.73 square meters (mL/min/1.73 m\^2) calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
* Must sign an informed consent form (ICF) indicating they understand the purpose of, and procedures required for, the study and are willing to participate in the study
* If a woman, except for postmenopausal women, must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) at screening and urine (beta-hCG) pregnancy test on Day 1 of each treatment period
* Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies

Exclusion Criteria:

* Participant is a woman who is pregnant, breastfeeding, or planning to become pregnant during this study or within 34 days after the last study drug administration
* History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, gastrointestinal disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
* Clinically significant abnormal values for hematology, coagulation, clinical chemistry (including thyroid-stimulating hormone \[TSH\] at screening only), or urinalysis at screening or on Day 1 prior to the first dosing, including: Hemoglobin and hematocrit less than (\<) lower limit of normal; Platelet count \< lower limit of normal; and activated partial thromboplastin time (aPTT) or prothrombin time (PT) greater than (\>) 1.2\* upper limit of normal (ULN)
* Clinically significant abnormal physical examination, vital signs, or 12 lead ECG at screening or at admission to the study center on Day 1 prior to first dosing, as deemed appropriate by the investigator
* Participants with a history of excessive menstrual bleeding
Improving Sickle Cell Disease (SCD) Care Using Web-based Guidelines

The overall goal of this proposed project is to 1) increase co-management between sickle cell specialists and primary care providers (PCP's); 2) increase the use of hydroxyurea (HU) which prevents Vaso-Occlusive Episode (VOE), EDs and subsequent hospitalizations, and death; 3) identify and link patients not receiving primary or SCD specialty care to care, and 4) shift healthcare use from EDs and hospitalizations to primary and specialty co-management. Many persons with SCD experience a poor quality of life, serious medical complications and frequent painful events that require treatment from SCD specialty care, primary care and emergency department (ED) providers. There are two dominating models of care in the United States; neither are ideal. Many people with SCD have all of their healthcare needs addressed by sickle cell specialists who do not typically provide primary care and are often geographically distant from the patients' home. Other sickle cell patients receive all of their care in EDs. Both models are inadequate and result in an alarmingly high number of ED visits for many patients. Current care models are neither cost efficient nor promoting optimal patient outcomes. To improve outcomes, the investigators will implement a new model of care for SCD using nurse care managers, web based-interactive algorithms, and test if additional patient provided coaching can improve outcomes.

To inform the model, the investigators will conduct an initial in-depth multi-level assessment of the barriers to care and implementation of the NHLBI "Evidence-Based Management of Sickle Cell Disease". With barriers and facilitators identified at the patient, provider, healthcare organization and community levels, the investigators will develop another study evaluation interventions that may improve the barriers.

Eligibility Criteria:
Inclusion Criteria:

- SCD patients in the 31 geographic counties surrounding Duke with genotypes Hemoglobin SS, SC, Sβ° or, Sβ+.

and -Parents of 15-20 year old SCD patients in the 31 geographic counties surrounding Duke with genotypes Hemoglobin SS, SC, Sβ° or Sβ+.

and

-Healthcare providers of sickle cell patients in the 31 geographic counties surrounding Duke

Exclusion Criteria:

* Non-English speaking
In Turkish Version Lumbar Spine Surgery Expectation Survey

The aim of this study was to determine the Turkish validity and reliability of Lumbar Spine Surgery Expectations Survey developed by Mancuso.

Although success in lumbar spine surgeries depends on many factors, it has been reported that one of the most important of these factors is patient expectations. In order for patients and health professionals to have the same priorities and meet the same realistic goals, it is necessary to understand what patients expect. Lumbar spine surgery expectations scale was created by Mancuso et al. The aim of this study was to determine the Turkish validity and reliability of Lumbar Spine Surgery Expectations Survey developed by Mancuso.

Eligibility Criteria:
Inclusion Criteria:

* speak Turkish
* arescheduled for lumbar spine surgery by one of two participating spine surgeons

Exclusion Criteria:

* have cognitive deficits
* refuse to participate
Viscoelastic Tests-Guided Therapy In Liver Transplantation

BACKGROUND: Perioperative bleeding and transfusion are important causes of morbidity and mortality in patients undergoing liver transplantation. The aim of this study is to assess whether viscoelastic tests-guided therapy with the use of synthetic factor concentrates impact transfusion rates of hemocomponents in adult patients undergoing liver transplantation.

METHODS: This is an interventional before-after comparative study. Patients undergoing liver transplantation before the implementation of a protocol using thromboelastometry and synthetic factor concentrates were compared to patients after the implementation. Primary outcome was transfusion of any hemocomponents. Secondary outcomes included: transfusion of red blood cells (RBC), fresh frozen plasma (FFP), cryoprecipitate or platelets, clinical complications, length of stay and in-hospital mortality.


Eligibility Criteria:
Inclusion Criteria:

* Deceased Donor Liver Transplantation
* Chronic Liver Disease

Exclusion Criteria:

* Acute Liver Failure
* Combined Transplantation
* Re-Transplantation is Less Than 30 Days After the First Transplant
Radioguided Occult Lesion Localisation by Indocyanine Green

Breast cancer is the most common cancer in women. It is the main cause of cancer deaths among women. The incidence of non-palpable tumors is estimated at 60%. Their better prognosis and their small size encourage the investigators for finding methods simpler and more efficient to treat them by breast-conserving surgery with acceptable cosmetic results.

The pre-operative detection of the tumor lesion is currently carried out by two methods: the radioactive seed localization and guidewire technique. Each has its disadvantages: the guidewire is uncomfortable for the patients (pain, hematomes..), whereas the radiocolloid requires a specialized and complex organization around this radioactive product.

Recently, a novel method of using indocyanine green (ICG) fluorescence has been described in breast cancer and seems promising.

In this study, investigators evaluate the feasibility and performance of indocyanine green fluorescence in non-palpable tumor detection in comparison with radioactive seed localization (ROLL)

Secondary objectives are evaluate the feasibility of the location by the radiologist, feasibility of detection by the surgeon, study of the product and the probe.

The study is prospectively conducted during six months of 2017-2018 in the department of gynaecology of Montpellier .

This study includes ten women. Patients will receive both techniques: indocyanine green fluorescence (experimental technique) and radiocolloid (reference technique).

Inclusion will be during the preoperative consultation after checking the inclusion / non inclusion criteria and signing a written consent.

Radioactive localization with technetium will be done on surgery eve like usual. Fluorescence localization with ICG will be done in the operating room under general anesthesia by the radiologist under ultrasound.

By a probe (Euromedical instruments), surgeon identified and marked the site of the skin by observing the area of the ICG fluorescence. Then, in the same way, the surgeon marked the tumor by the radioactive probe detecting the radioactive signal.

An picture will be made of these two markers and it will be noted the distance between them. Dissection and excision of the tumor using the radiocolloid probe (no modification of surgical management). At the end of the surgical procedure, verification of no residual radioactivity and no residual fluorescence. Again, surgeon identified and marked in the excised sample the area of fluorescence and radioactive. The pathological examination of the resected specimen will describe positions of mark compared tumor.

The following data were recorded prospectively: demographics, medical history, localization of tumor, surgery, pathology results.

Eligibility Criteria:
Inclusion Criteria:

* Woman Age ≥ 18 years
* Non-palpable tumor
* Single tumor
* First breast surgery
* Histology: ductal carcinoma
* Written consent
* Being affiliated or benefiting from a French social security system

Exclusion Criteria:

* palpable tumor
* multifocal tumor
* antecedent of breast surgery
Assessment of Smoking, Vaping, and Alcohol Consumption Behavior

To assess smoking, vaping, and alcohol consumption behaviors via online surveys in the population. Further, the objective is to administer additional surveys to assess which methods (e.g., pen-and-paper records, a smartphone app) for monitoring smoking, vaping, alcohol intake, and food intake are preferred by the study population.

Many smokers believe that smoking helps them to control their weight, and concerns about weight gain can interfere with smoking cessation. In fact, nicotine has been shown to suppress appetite and increase resting metabolic rate, and smoking also serves as a behavioral alternative to eating or a distraction from hunger or food cravings. E-cigarettes are frequently marketed as the safer and healthier alternative to smoking, and some e-cigarettes are in fact actively advertised for weight management and/or suppression of food cravings, encouraging smokers to make the switch. In contrast, alcohol consumption has been shown to increase appetite and food intake and at the same time is associated with smoking and vaping.

Therefore, it is possible that participants who smoke or vape for weight control, particularly those who also regularly consume alcohol, would benefit from a lifestyle program that encompasses dietary counseling and exercise to prevent weight gain after smoking cessation. Additionally, methods to assess smoking, vaping, alcohol intake, and food intake (i.e., ingestive behaviors) historically relied on self-report, though the investigator's group has developed smartphone apps that allow people to capture images of their intake and/or self-report their intake in the app. App-based methods offer advantages, including the real-time transfer of data, and it is presumed that people will believe that apps are an easier and preferred method to capture ingestive behaviors, yet this assumption has not yet been thoroughly examined.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18 to 85 years are eligible to complete the Demographics Questionnaire and the Food Intake Assessment Preference Questionnaire.
* Individuals in the same age range who regularly smoke cigarettes can complete the Smoking Questionnaire and the Smoking Assessment Preference Questionnaire, in addition to the Demographics Questionnaire and the Food Intake Assessment Preference Questionnaire
* Individuals in the same age range who regularly use e-cigarettes (vape) can complete the Vaping Questionnaire and the Vaping Assessment Preference Questionnaire, in addition to the Demographics Questionnaire and the Food Intake Assessment Preference Questionnaire
* Individuals in the same age range who regularly drink alcohol can complete the Alcohol Consumption Questionnaire and the Alcohol Consumption Assessment Preference Questionnaire, in addition to the Demographics Questionnaire and the Food Intake Assessment Preference Questionnaire

Individuals who engage in several of these behaviors can complete all questionnaires that apply.

Exclusion Criteria:

• Individuals who are unwilling to participate in this survey
Primary Care Prevention of Stimulant Diversion by High School Students With ADHD

The purpose of this study is to test clinical strategies that pediatric providers may use to prevent misuse and diversion of stimulants by their adolescent patients with ADHD.

This study addresses the increase in diversion (selling, sharing, loaning, or trading) of prescription stimulant medications by adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). In the absence of any standardized, empirically evaluated clinical strategies or interventions to prevent or decrease stimulant diversion, this project will test the effect of a brief provider-led intervention for stimulant diversion prevention among adolescents being prescribed stimulant medication in pediatric care. The investigators hypothesize that adolescents treated in pediatric practices randomized to the intervention will report decreased diversion, increased perceived risk of harm, and decreased intentions to divert compared to adolescents treated in pediatric practices randomized to treatment-as-usual. Secondary analyses will examine the effect of the intervention on additional contributing variables (e.g., patient, parent, and provider attitude and behavior change).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ADHD
* Treatment with stimulant medication
* Enrolled in or attending middle school or high school
* Parent/guardian willing to participate
* Receiving treatment at one of the 7 pediatric practices participating in the protocol

Exclusion Criteria:

* Not diagnosed with ADHD
* Not treated with stimulant medication
* Not enrolled or attending middle school or high school
* Parent/guardian unwilling to participate
* Not receiving treatment at one of the 7 pediatric practices participating in the protocol