cyrilzakka/clinical-trials huggingface dataset:
Effects of Cariprazine on Cardiac Repolarization in Patients With Schizophrenia

This study will evaluate the effects of sequential multiple dose regimens of cariprazine on cardiac repolarization in patients with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Men or women, age 18 to 50, inclusive
* Symptoms of schizophrenia or schizoaffective disorder first appearing a minimum of 1 year before screening
* Negative pregnancy test
* Normal physical examination results, vital signs, and clinical lab test results

Exclusion Criteria:

* Axis II disorder severe enough to interfere with the study
* Smoking more than 20 cigarettes a day
* History or presence of cardiovascular disorder
* Pregnant/breast-feeding and/or planning to become pregnant/breast-feed
* Imminent risk of injuring self or others or causing significant property damage
The Effect of Stoma Care Education on the Knowledge and Skill Levels of Pediatric Surgery Nurses

This project; It is a quasi-experimental prospective study in a single group pre-test post-test order. No randomization will be made in the selection of the sample, and 30 nurses working in the Pediatric Surgery Clinic in hospitals in Izmir and meeting the inclusion criteria will be included in the study. The data of the study will be collected through the Nurse Descriptive Characteristics Questionnaire and the Pediatric Stoma Care Knowledge and Skills Questionnaire. Pre-training introductory characteristics and pediatric stoma care knowledge and skill level of all nurses participating in the study will be measured. After the measurement, the nurses participating in the study will be given training on pediatric stoma care. Immediately after the training and three months later, the pediatric stoma care knowledge and skill levels of the nurses participating in the study will be re-measured. The introductory characteristics of the nurses involved in the project will be given as number and percentage distributions. Comparisons between nurses' introductory characteristics and Stoma Knowledge and Skills Questionnaire before and after education; It will be evaluated by non-parametric or parametric appropriate test. Comparisons between nurses' Stoma Knowledge and Skills Questionnaire scores in the pre- and post-education period will be evaluated by non-parametric or parametric appropriate test in dependent groups. The statistical significance value of the project was determined as p≤0.005. It is planned that the results of the project will mediate an international article and statement in which the effect of stoma care education on the knowledge and skill level of pediatric surgery nurses is presented. As a result of the project, if it is determined that stoma care education has an effect on the knowledge and skill level of pediatric surgery nurses, it is predicted that the quality of care of children with stoma who receive care in other institutions and organizations can be increased and the comfort of the child can be increased.


Eligibility Criteria:
Inclusion Criteria:

* Working in the Pediatric Surgery Clinic
* Volunteering to participate in the study

Exclusion Criteria:

-Having received any previous training on stoma care
Sanitation Demand Creation in Peri-Urban Slums of Lusaka, Zambia

This intervention will experimentally test the hypothesis that sanitation can be improved in a peri-urban setting using state-of-the-art behaviour change communications.

Formative research indicated that landlords are the effective decision-makers about investments in sanitation on their plots (which can include a number of tenant households as well). Landlords will therefore be the primary targets of the intervention. The study will take the form of a randomized controlled trial of the intervention evaluated at the plot level. The intervention will invite enrolled landlords to a series of meetings in which various mechanisms will be used, each designed to increase their likelihood of improving the toilet(s) on their plot. These meetings will be the main vehicle for a status-building campaign associated with increasing wealth by improving plot sanitation, understanding tenants' implicit demand, understanding the processes by which toilets can be improved, and a competition rewarding landlords that make the greatest improvements to the improvement of their toilet(s). The desired improvements will be measured via multiple primary outcomes that measure aspects of changes to hardware and software components, including indicators of hygienic quality, psychological desirability, accessibility, and ecological sustainability. This is because the investigators argue that, to have a significant impact on population-level diarrheal disease indicators, any sanitation solution must be:

* effective at reducing exposure to pathogens (i.e., hygienic),
* desirable (i.e., seen as valuable or humane), and
* accessible (i.e., no one excluded), so that it can be used by all
* for a reasonably long time (i.e., sustainable)


Eligibility Criteria:
Plots will be selected for inclusion in the study based on meeting the inclusion criteria. The intervention will be delivered to the landlord on each plot assigned to the intervention arm.

Intervention Inclusion Criteria:

* Plot located in Bauleni compound
* Adult landlord (age 18 or higher) resides on plot

Intervention Exclusion Criteria:

\* None

Data will be collected from the landlord and one randomly selected tenant from all eligible adult tenants on each plot.

Data Collection Inclusion Criteria:

\* Adult landlord or tenant (age 18 or higher) resides on selected plot most of the time

Data Collection Exclusion Criteria:

\* None
The Effect of Local Anesthetic Volume Within the Adductor Canal on Quadriceps Function Evaluated by Electromyography

Our aim is to investigate which components of the quadriceps femoris muscle are affected following an ACB with different volumes (10, 20 and 30 ml) of 1% lignocaine evaluated by electromyography. Both a placebo treatment (20ml saline) and the femoral nerve block (20ml lignocaine 1%) as an active comparative will be used for model control. Further, we want to investigate the effect of volume on motor block. This will be evaluated by measuring the Maximum Voluntary Isometric Contraction (MVIC) of the quadriceps femoris muscle.

The ACB has a well-proven analgesic effect after TKA, but we do not know which nerves that are affected by the block. Aside being a motor nerve, the nerve to the vastus medialis of the quadriceps femoris muscle, contains the second largest sensory contribution from the femoral nerve. It is probable that some of the analgesic effect of the ACB arises from blocking this nerve.

Even though the ACB is mainly a sensory nerve block, a study in healthy volunteers showed a small decline by 8% in quadriceps muscle strength(10). It is speculated that the decline in muscle strength was caused by the spread of local anesthetic to the nerve supplying the vastus medialis of the quadriceps femoris muscle. Three out of eleven of the volunteers experienced an even larger decline of 25 % in quadriceps muscle strength. It has been argued that this decline likely was caused by a proximal spread of the local anesthetic to the femoral triangle thereby resulting in an affection of the femoral nerve. In this study, a volume of 30 ml of local anesthetic was used.

We do not know the optimal volume for the ACB and we find it relevant to investigate to what extent and which parts of the quadriceps muscle gets affected when different volumes of a local anesthetic are injected into the adductor canal. Selective affection of the different components of the femoral quadriceps muscle can be assessed by non-invasive EMG recordings. Further, the quadriceps femoris muscle strength will be evaluated by measuring the MVIC following the different volumes. The EMG recordings will be voluntary (vEMG) measured during MVIC and stimulated (sEMG). sEMG is measured during transcutaneous electrical stimulation of the femoral nerve.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Subjects who gave their written informed consent to participating in the study after having fully understood the contents of the protocol and re-strictions.
* ASA 1
* Male
* BMI 18-30
* Physical exercise 1-3 hours/week

Exclusion Criteria:

* Subjects who cannot cooperate with the study.
* Subjects who cannot understand or speak Danish.
* Subjects with allergy to the medicines used in the study.
* Subjects suffering from alcohol and/or drug abuse - based on the investi-gator's opinion.
* Pathology or previous surgery or trauma to the lower limb.
* Intense exercise 24 h before the tests
* Intake of any analgesics 24 h prior to baseline measurements.
Efficacy and Safety of SR58611A in Patients With a Generalized Anxiety Disorder

To evaluate the efficacy of a fixed dose of SR58611A (350mg q12) compared to placebo in patients with GeneralizedAnxiety Disorder (GAD) using escitalopram (10 mg qd) as positive control. To evaluate the tolerability and safety of SR58611A in patients with GAD.

The current study will be conducted to evaluate the efficacy, safety, and tolerability of SR58611A (350 mg q12) compared to placebo in patients with generalized anxiety disorder (GAD), using escitalopram (10 mg qd) as a positive control. This is an 8-week, double-blind, randomized, 3-parallel-group, placebo- and escitalopram-controlled, study.A 1-week, placebo, single-blind period precedes the 8-week randomized treatment period. A Safety Follow up Visit (Segment C) is scheduled 1 week after the acute treatmentperiod (Segment B) or early termination. This trial is designed to compare the efficacy, safety, and tolerability of SR58611A to placebo. In this study, escitalopram, a selective serotonin reuptake inhibitor (SSRI) antidepressant, is used as a positive control and has been chosen as the comparator agentas it is approved for treatment of GAD at a dose of 10 mg once daily.

Eligibility Criteria:
Inclusion Criteria:

Main inclusion criteria:

1. Out-patients, 18 year and older.
2. Generalized Anxiety Disorder (GAD) according toDSM-IV-TR criteria / MINI.
3. Minimum total score of 20 on the 14-item HamiltonAnxiety Rating Scale (HAM-A)

Exclusion Criteria:

Main exclusion criteria:

1. Patients with a diagnosis of Major Depressive Disorder within 6 months of study entry.
2. Patients with a Montgomery-Asberg Depression Rating Scale (MADRS) total score of 18 or higher
3. Patients who are assessed to have a moderate to high current risk for suicide according to the MINI, or at imminent risk for a suicide attempt
4. Patients with other current anxiety disorder (within 6 months) assessed with the MINI:- Agoraphobia, social phobia,- Panic disorder,- Obsessive compulsive disorder,- Post-traumatic stress disorder, acute stress disorder.
5. Patients with a lifetime history according to the MINI of:- Bipolar disorders,- Psychotic disorders,- Antisocial Personality Disorder.
6. Patients with a current history according to the MINI of:- Anorexia nervosa or bulimia nervosa in the past 6 months,- Alcohol dependence or abuse or substance dependence or abuse in the past 12 months except nicotine or caffeine dependence.
7. Patients who have received non-pharmacologic, somatic treatments for psychiatric disease
8. Patients who have initiated, stopped, or changed the frequency or nature of psychotherapy within 3 months prior to screening.
A Study to Evaluate the Efficacy and Safety of SHR0302 in Patients With Rheumatoid Arthritis

This study is to evaluate the efficacy and safety of different doses of JAK1 inhibitor SHR0302 in subjects with moderate to severe active rheumatoid arthritis who had inadequate response to conventional synthetic DMARDs.


Eligibility Criteria:
Inclusion Criteria:

* Provide signed informed consent.
* RA diagnosis consistent with the 2010 ACR/EULAR criteria;
* Moderate to severe RA defined by 6 or more tender joints, 6 or more swollen joints (68- or 66-joint count), and an ESR of 28 mm/h or greater or a CRP level greater than 5mg/L.
* Subjects were required to have an inadequate response to treatment with csDMARDs before baseline.
* If subjects are taking permitted csDMARDs or low-dose corticosteroid orally at baseline , the stable doses should have lasted for more than 4 weeks already.
* BMI ≥18 kg/m2

Exclusion Criteria:

* Pregnant women or refuse to receive contraception during the study.
* Lab abnormality within 4 weeks of randomization as follows: WBC count \<3.0×10\^9/L；neutrophil count\<1.5×10\^9/L;hemoglobin level\<90.0 g/L ; platelet count \<100×10\^9/L; AST or ALT levels greater than the upper limit of normal; HBsAg or HCV or HIV antibody positivity.
* History of another autoimmune rheumatic disease ; history of cancer or infection including tuberculosis and hepatitis; history of important cardiovascular events or thrombotic diseases.
* Previous treatment with JAK inhibitor or cytotoxic drugs; bDMARDs within 6 months of randomization; other strong immunosuppressants within 3 months of randomization.
Efficacy and Safety of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis

The purpose of this study is to assess the efficacy and safety of tocilizumab vs placebo, in combination with stable, ongoing therapy, with regard to reduction in signs and symptoms in patients with moderate to severe active RA and inadequate response to current DMARD treatment


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>= 18 years of age
* Active RA of \> 6monts duration
* Received permitted DMARDs each at a stable dose for at least 8 weeks

Exclusion Criteria:

* Rheumatic autoimmune disease other than RA
* Significant systemic involvement secondary to RA
* ALT or AST \> ULNⅹ1.5
* Platelet count \< 100,000/mm3
* Hemoglobin \< 8.5 g/dL
* White blood cells \< 3,000/mm3
* Absolute neutrophil count \< 2,000/mm3
* Absolute lymphocyte count \< 500/mm3
MRI Laryngeal Imaging With a Surface Coil

To determine if high resolution MRI can detect early invasion of cartilage by laryngeal carcinoma, and to determine if high resolution MRI may be superior to conventional MRI imaging or CT imaging to detect cartilage invasion.

The purpose of this study is to use a new MRI imaging coil developed for enhancing structures made of cartilage to determine if the device can produce improved images of the human larynx. In addition, if enhanced images can be obtained, a further purpose will be to determine if, in patients with laryngeal cancer, whether or not early invasion of cartilage can be detected. Patients with laryngeal cancer will be asked to undergone an MRI scan using this new image-enhancing coil to see if cartilage invasion can be detected. Patients will be followed during and after treatment to determine their ultimate response to treatment. No additional MRI scans for the purposes of this protocol will be performed other than the initial pretreatment scan.

We hope to determine if this new MRI imaging device can detect early cancer invasion of the laryngeal cartilages in patients with laryngeal cancer. Since this modality has never been attempted before on the human larynx, we are simply looking for the presence or absence of cartilage destruction. Both conventional CT and conventional MRI are poor at recongnizing this finding. High resolution MRI may allow the detection of this finding or it may not - detection of this finding is the endpoint.

Eligibility Criteria:
Inclusion Criteria:

* Patients with benign or malignant neoplasm of the larynx.
* Patients who have undergone prior surgery, radiation therapy, or chemotherapy for cancer of the laryngopharynx will be eligible to participate.
* Patients 18 years of age and older at time of evaluation, male and female, all ethnicities.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Pregnancy
* Claustrophobia.
* Anatomic parameters which preclude scanning, such as limited range of neck motion, or inability to remain flat for at least 15 minutes.
* Patients with implanted devices (eg, defibrillator, pacemaker) that are a known contraindication to magnetic resonance imaging.
* Allergy to gadolinium contrast.
Relevance and Nuisances of Respiratory Rate Alarm Generated by Multi-parametric Monitors in Non Ventilated ICU Patients

In ICU setting, a large number of medical devices are attached to patients, generating numerous alarm signals. Several studies have demonstrated that most of these alarms are not clinically relevant and tend to lower the attentiveness of healthcare professional and, in turn, lower patient safety.The aim of the study is to assess the relevance of respiratory rate alarm on a monitoring device in non-ventilated ICU patients.

The investigator primary hypothesis is that this alarm is potentially useless. If this hypothesis is confirmed, a second interventional trial will be conducted on the impact of this alarm removal.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Patient hospitalized in ICU
* Need for monitoring

Exclusion Criteria:

* Invasive mechanical ventilation
* Non-invasive mechanical ventilation
* Patient not monitored
* Patient already included in this study
* Patient hospitalized without consent and/or deprived of liberty by court's decision
* Patient under guardianship or curators
* Lack of social insurance
* Patient's or next of kin's refusal
Pulse Oximetry_Performance Testing- PCBA-1 (Printed Circuit Board Assembly)

To determine accuracy specifications of the Pulse oximeter.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects between the ages of 18 to 50 years (inclusive).
2. Must undergo a physical examination by a licensed physician, advanced practice nurse or physician assistant, including a 12 lead ECG, a medical history, and a blood test checking complete blood count and screening for sickle cell trait or disease
3. All female volunteers must have a negative urine pregnancy test prior to participation.

Exclusion Criteria:

1. Pregnancy or lactating women
2. Unexplained syncopal episodes
3. Hypertension (defined as a systolic pressure of \>145 mmHg or a diastolic pressure \>90 mm Hg on three consecutive readings)
4. Premature ventricular contractions (PVC's) that are symptomatic or occur at a rate of more than 5/minute
5. History of seizures (except childhood febrile seizures) or epilepsy
6. Routine use of tranquilizers and/or excessive anxiety
7. History of frequent headaches or migraines
8. History of stroke
9. Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect our ability to test multiple sensors
10. History of "altitude sickness" defined as headaches, malaise or dizziness when in the mountains or in an aircraft at altitude significantly above sea level for a prolonged period of time (\> 1 hour)
11. History of significant respiratory disease, such as severe asthma, emphysema, etc.
12. Sickle cell disease or trait.
13. The use of medications, pre-existing medical conditions, treatment for a medical condition or any other reason deemed relevant by the clinician conducting the study.
14. Abnormal ECG finding
15. Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain)
16. Prior or known allergies to heparin.
17. History of transient ischemic attacks or carotid artery disease
18. History of myocardial ischemia, angina, myocardial infarction, congestive heart failure or cardiomyopathy
19. History of chronic renal impairment
20. History of recent arterial cannulation (less than 1 month prior to study)
21. History of complications from previous arterial cannulation
22. Current use of blood thinners
STRAIN - Work-related Stress Among Health Professionals in Switzerland

The aim of this study is to identify work stressors, stress reactions and long-term consequences among nurses, physicians, medical-technical and medical-therapeutic professions in Switzerland and to reduce those factors by an educational intervention for the supervisors.

Methods: This study is a cross-sectional design and randomly selected hospitals, nursing homes and home care organizations. The study sample included nursing staff and midwives, physicians, medical-technical and medical-therapeutic professionals at all hierarchical levels. Data were collected using self-report questionnaires and analysed using multiple regression models.

Eligibility Criteria:
Inclusion Criteria:

* Employee within a participating health organization in Switzerland
* Health care professional (nurse, medical-technical medical-therapeutical profession, physician)

Exclusion Criteria:

* Health professionals without an fixed employment contract
Evaluation of Pain Regression in Patients With Myofascial Facial Pain Using Dextrose, Local Anaesthesia and Saline.

The aim of this study is to compare the treatment effects of dextrose prolotherapy, saline, and mepivacaine for deactivating myofascial trigger points within the jaw muscles.


Eligibility Criteria:
Inclusion Criteria:

- 1. Presence of active myofacial pains in jaw muscles, previously identified by manual palpation.

2. Age ≥ 18 years. 3. Willingness to follow instructions

Exclusion Criteria:

* 1. Therapeutic intervention for myofascial pain within the past month before the study, such as using of medications for pain control or wearing of occlusal splint.

  2. Clinical conditions such as pregnancy. 3. Medical problems that may interfere with the procedures such as bleeding disorders, trigeminal neuralgia.

  4. Recent facial or neck trauma; medication or adjunctive treatment (eg, physiotherapy) that could not be stopped during the study; or allergy to local anesthetic solutions.

  5. Cognitive impairment or exhibited inadequate cooperation.
Chemotherapy and Liver Cirrhosis in Frequently-associated Cancers

Cirrhosis and cancers of the upper digestive tract, colorectal and ENT share common risk factors. Liver cirrhosis can change the elimination of cancer drugs.

Precise data on management and outcome of patients with liver cirrhosis undergoing chemotherapy are lacking. Most patients have been excluded from clinical trials evaluating conventional therapies.

The study of tolerance, side effects, and outcome in patients with cirrhosis could help improve chemotherapy management for better tolerance and efficacy.

The main objective is to estimate the frequency of liver cirrhosis among patients evaluated in CPR for ENT, upper digestive or colorectal cancer.

Secondary objective includes the evaluation ofthe impact of cirrhosis on the management of chemotherapy by comparing cirrhotic patients' outcomes with a control group of matched non-cirrhotic patients.


Eligibility Criteria:
Inclusion Criteria:

* Follow-up for the following cancers: upper digestive sphere (stomach, esophagus, pancreas, bile ducts), colorectal, ENT
* Theoretical indication of conventional chemotherapy based on 5FU, anthracyclins, platinum salts, gemcitabin, taxans, irinotecan or antiangiogenic drugs, anti-EGFR or anti-HER 2 therapies, according to management guidelines
* Beneficiary of a social security system
* Dated and signed non-opposition consent

Exclusion Criteria:

* Other concomitant primary cancer
* Pregnant women
* Patients under guardianship, curatorship or justice protection