cyrilzakka/clinical-trials huggingface dataset:
Cognitive Behavioral Therapy-Based Group Counseling

The university environment presents a valuable opportunity to reach the young population of society, which has a high risk of depression, and to provide protective mental-health services. This study aimed to evaluate the effectiveness of cognitive behavioral therapy-based group counseling focused on the depressive symptoms, anxiety levels, automatic thoughts, and coping ways among undergraduate nursing students with mild to moderate depressive symptoms.

This study aimed to evaluate the effectiveness of cognitive behavioral therapy-based group counseling focused on the depressive symptoms, anxiety levels, automatic thoughts, and coping ways among undergraduate nursing students with mild to moderate depressive symptoms.

The study was completed with a total of 63 participants (n=31 for the intervention group and n=32 for the control group) in the 2017-2018 academic year. The effect of the intervention was evaluated with the Beck Depression Inventory, Beck Anxiety Inventory, Automatic Thoughts Questionnaire, and Ways of Coping Questionnaire. The measurements were taken 3 times: pre-test, post-test, and 2-months post-test.

Eligibility Criteria:
Inclusion Criteria:

* Having mild depressive symptoms according to the BDI
* Having moderate depressive symptoms according to the BDI
* Being native speakers of Turkish
* Agreeing to participate in the entire intervention process

Exclusion Criteria:

* Having substance abuse
* Having another psychiatric diagnosis
* Using psychotropic drugs
* Receiving other counseling or therapy
An Extension Study to Assess the Long-Term Safety and Efficacy of Pasireotide in Participants With Acromegaly

Acromegaly is a rare, serious condition characterized by chronic hypersecretion of growth hormone (GH), generally caused by a GH-secreting pituitary adenoma. The study assessed the long-term safety and efficacy of pasireotide in participants with acromegaly.


Eligibility Criteria:
Inclusion Criteria:

* Participants who have completed all four treatment regimens in the core study CSOM230B2201 (NCT00088582) and achieved biochemical control in growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels after at least one month of pasireotide administration at any of the three doses.
* Participants who did not experience any unacceptable adverse events or tolerability issues during the core study CSOM230B2201.

Exclusion Criteria:

* Participants who experienced or developed compression of the optic chiasm causing any visual field defect during the core study CSOM230B2201.
* Participants who required a surgical intervention for relief of any sign or symptom associated with tumor compression during the core study CSOM230B2201.
* Participants who experienced or developed congestive heart failure, unstable angina, sustained ventricular tachycardia, ventricular fibrillation or acute myocardial infraction during the core study CSOM230B2201.

Other protocol-defined inclusion/exclusion criteria may apply.
Mindfulness Therapy for Individuals With Lung Cancer

Managing psychological and physical symptoms to improve quality of life in patients with lung cancer are a major public health concern. Mindfulness-based therapies are showing promise in modifying psychological distress and improving quality of life in some cancer groups, but little testing has included lung cancer samples. Mindfulness-based therapies integrate meditation, breathing, and gentle yoga practices to promote an attitude of nonjudgmental acceptance and awareness of bodily states. Such strategies may promote well being, self-regulation, and symptom management. The study purpose was to test the acceptability, feasibility, and symptom / health-related quality of life (HRQOL) outcomes of a home-based mindfulness intervention for individuals with advanced lung cancer during non-curative treatment (radiation and/or chemotherapy). Acceptability and feasibility were measured via patient consent and retention rates, therapy expectancy, study adherence, attrition reasons, and quality assurance indicators. Efficacy was determined via symptom and HRQOL (health perceptions, physical and emotional function) outcomes. 40 patients undergoing treatment of non-small cell lung cancer were randomized to receive either six weekly mindfulness sessions (N=20) or an attention control condition (N=20). Outcome data was obtained at baseline (Time 1), post-intervention (Time 2, week 8), and four weeks after completion (Time 3, week 11). In addition, both groups received weekly symptom assessment interviews. The hypothesis was that the mindfulness group would report better symptom management and HRQOL (lower worry, dyspnea, insomnia, depression; higher physical and social function; more positive health perceptions) than the attention control group at the protocol end and that these differences will be sustained at Time 3.

The final sample (n = 32) included 16 patients in the intervention and 16 in the attention control group (study attrition (n = 8, 20%).

Eligibility Criteria:
Inclusion Criteria:

1. Able to understand and speak English
2. at least 21 years old
3. active treatment for a diagnosis of non-small cell lung cancer
4. Karnofsky score \> 80
5. have a telephone by which they can be reached

Exclusion Criteria:

1. current substance abuse other than tobacco
2. active treatment for psychiatric disorders excluding depression, and/or use of antipsychotic medications that would impede study participation.
3. cognitive impairment
4. active participation in mindfulness-based classes, guided imagery, yoga, or relaxation therapy courses
5. diagnosis of small cell lung cancer
Supervised Asthma Medication in Schools (SAMS)

The investigators hypothesize that school-based, direct supervision of daily controller therapy will result in more effective asthma control, as assessed by the Asthma Control Questionnaire than usual care. Additionally, as the result of enhanced asthma control and resulting decrease in health care utilization, school-based, direct supervision of daily controller therapy will result in lower cost per quality-adjusted life year (QALY) gained than usual care.

This research is being done to test if children with asthma will have fewer asthma symptoms if they are monitored at school to make sure they take their inhaled steroid medication (ICS) every day and take the medication the right way. All of the children with asthma in the school will be asked to participate. In the first year in one-half of the schools, children and school staff will participate in a standardized asthma education program presented by the American Lung Association (ALA). Children will have daily monitoring of their inhaled asthma medication. The other half of schools will continue with the usual treatment of children with asthma. In the second year of the study, all schools and children will have the asthma education program and monitoring. Parents will be queried quarterly for information about their child's asthma.

Eligibility Criteria:
Inclusion Criteria:

* A child with asthma attending a Tucson Unified School District elementary school selected for the study.

Exclusion Criteria:

* No asthma.
* Not attending a Tucson Unified School District elementary school selected for the study.
Dynamic Needle Tip Positioning Modification Technique in Short Axis Approach

The aim of the present study is to compare between Dynamic Needle Tip Positioning Modification Technique in Short Axis Approach (DNTP - SA) and Long Axis (LA) Approach for Ultrasound-guided Arterial Cannulation as regard time to successful arterial cannula insertion as well as the success rate in the first trial of insertion, number of attempts till successful arterial line placemen, complications, and operators' satisfaction.

Intraoperative Arterial cannulation is recently frequently required especially in high-risk patients or patients with expected major fluid shift.

The most common site for arterial cannulation is the radial artery because of ease of accessibility, dual blood supply to the hand via the ulnar artery, and a low rate of complications. Complications from arterial cannulation include thrombosis, hematoma formation, edema and vasospasm.

Two approaches are basically identified for ultrasound-guided radial artery cannulation, i.e., short-axis out-of-plane (SA-OOP) and long-axis in-plane (LA-IP) techniques.

The dynamic needle tip positioning (DNTP) technique uses the short-axis view of the radial artery with gradual advancing of the needle till reaching the radial artery. Meanwhile, the ultrasound probe is being moved proximally in advance of the needle tip until it disappears from the ultrasound image. The cannula then advanced in the direction of the artery

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 70 years.
* Both sexes.
* American Society of Anesthesiologists physical status II-IV.
* Patients scheduled for elective surgery procedure that requires the use of invasive arterial pressure monitoring, as determined by the attending anesthesiologist.

Exclusion Criteria:

* Emergency patients or with Hemodynamic instability.
* Patients who have cellulitis or infection at the site of insertion.
* Patients with a positive modified Allen test.
* Raynaud disease or any Peripheral vascular disease.
* Patients with Multiple previous radial artery interventional therapies in the previous 30 days.
* Patients scheduled for Surgery at site of insertion like forearm flap.
* Refusal to participate by the patient.
Quality of Life in Patients With Inoperable Malignant Bowel Obstruction

The primary objective of the study is to evaluate the impact on quality of life of Lanreotide Autogel 120 mg in combination with standard care, in comparison to the standard care alone, in subjects affected by inoperable malignant bowel obstruction.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must demonstrate willingness to participate in the study and to be compliant with any protocol procedure.
* Provision of written informed consent prior to any study related procedure.
* Diagnosis of an inoperable malignant bowel obstruction, confirmed by appropriate imaging report.
* In case of peritoneal carcinomatosis, diagnostic confirmation by CT or MRI scan.
* Confirmed as inoperable after medical advice.
* Patient with a nasogastric tube or presenting with 3 or more episodes of vomiting every day in the last consecutive 48 hours.
* Patient life expectancy must be more than 14 days.

Exclusion Criteria:

* Has operable obstruction or any sub-obstruction.
* Has bowel obstruction due to a non-malignant cause; (hypokaliaemia, drug side-effects, renal insufficiency, etc).
* Has signs of bowel perforation.
* Has prior treatment with somatostatin or any analogue within the previous 60 days.
* Has a known hypersensitivity to any of the study treatments or related compounds.
* Is likely to require treatment during the study with somatostatin or any analogue other than the study treatment.
* Is at risk of pregnancy or lactation, or is likely to father a child during the study. Females of childbearing potential must provide a negative pregnancy test at start of study and must be using oral or double barrier contraception. Non childbearing potential is defined as post-menopause for at least 1 year, surgical sterilisation or hysterectomy at least three months before the start of the study.
* Has any mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
* Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardise the subject's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
Extension Study of NS-065/NCNP-01 in Boys With Duchenne Muscular Dystrophy (DMD)

This is an open-label, extension study of NS-065/NCNP-01 administered intravenously once weekly for an additional 192 weeks to boys with DMD who complete Study NS-065/NCNP-01-201.

This is a Phase II, multicenter, open-label, extension study of NS-065/NCNP-01 administered intravenously once weekly for an additional 192 weeks to boys with DMD who complete Study NS-065/NCNP-01-201. This study will evaluate the safety, tolerability, and clinical efficacy of NS-065/NCNP-01 at dose levels of up to 80 mg/kg/week administered by weekly IV infusion over an additional treatment period of 192 weeks or until enrollment in a separate long-term follow up program of NS-065/NCNP-01, whichever is earlier.

Patients who complete the Phase II Dose-finding Study NS-065/NCNP-01-201 are eligible to enroll.

Eligibility Criteria:
Inclusion Criteria:

1. Completed Study NS-065/NCNP-01-201 through Week 25.
2. Willing and able to comply with scheduled visits, investigational product administration plan, and study procedures.
3. Stable dose of glucocorticoid (GC), and is expected to remain on the stable dose for the duration of the study.

Exclusion Criteria:

1. Serious or severe adverse event in Study NS-065/NCNP-01-201 that precludes safe use of NS-065/NCNP-01.
2. Patient had a treatment which was made for the purpose of dystrophin or its related protein induction after completion of Study NS-065/NCNP-01-201.
3. Patient took any other investigational drugs after completion of Study NS-065/NCNP-01-201.
4. Patient was judged by the investigator and/or the Sponsor that it was not appropriate to participate in the extension study for other reasons.
Nitrous Oxide for Pain Management During IUD Insertion in Nulliparous Adolescent Women

This pilot study aims to assess the feasibility, acceptability, and effectiveness of using nitrous oxide (N2O) sedation for intrauterine device (IUD) insertions for nulliparous adolescent and young adult women in a primary care clinic setting.

The objective of this research study is to learn more about how to make the intrauterine device (IUD) insertion procedure more comfortable. IUDs are highly effective at preventing pregnancy and are also used to treat gynecological conditions such as endometriosis or heavy periods. Unfortunately, many adolescents and young adults do not get an IUD because the insertion procedure can be painful. Currently, there are no medications that successfully reduce pain during IUD insertion for adolescents in the outpatient clinic setting.

We plan to study if nitrous oxide sedation is a feasible strategy for improving the IUD insertion experience for adolescents and young adult women. Although nitrous oxide is already used to manage pain and anxiety in other medical settings (such as for pain during labor or dental procedures), nitrous oxide sedation has not been rigorously studied for IUD insertions in teenagers and young adults.

During phase one of our study ("pre-implementation phase"), study participants will receive current standard of care (ibuprofen) for managing pain during IUD insertions. In phase two ("post-implementation phase"), study participants will receive nitrous oxide sedation in addition to ibuprofen during IUD insertions. We will survey study participants to assess the feasibility, acceptability, and effectiveness of nitrous oxide sedation for IUD insertions in the primary care clinic setting.

This study will help clinicians understand whether nitrous oxide could be a practical and effective way to manage pain and anxiety for adolescents during IUD insertion procedures. Ultimately, we hope this study will lead to increased satisfaction with the IUD insertion procedure and increased use of this highly effective method of contraception among adolescents.

Eligibility Criteria:
Inclusion Criteria:

* nulliparous (no pregnancy of 24 weeks' duration or longer and not currently pregnant)
* adolescent females (14-24 years)

Exclusion Criteria:

* use of opioids, benzodiazepines, or marijuana within the past 24 hours
* failure to meet medical eligibility criteria for an IUD
* medical contraindications to NSAID use
* relative contraindications to N2O administration, including severe pulmonary disease, congenital heart disease, diseases associated with vitamin B12 deficiency, and sickle cell disease
Effects of Capnometry Monitoring in Post Anesthesia Care Unit

There is few information about the best capnometry value in recovery room for intubated awakening patients. Furthermore, capnometry values could influence ventilation applied by nurses on these patients. The aim of this study is to observe the effects of capnometry monitoring on intubated awakening patients in recovery room.

In France, there is actually no recommandation about capnography monitoring in recovery rooms. Nevertheless, some patients are still ventilated in post-anesthesia care units during awakening period. Alveolar hypoventilation could induce moderate hypercapnia, thereby stimulate central ventilatory command. However, this hypoventilation could delay the clearance of anesthetic gases. Capnometry monitoring could influence ventilation applied to these patients. Recovery rooms nurses would perform moderate hyperventilation in response to hign capnometry values. This method could enhance gases elimination, with faster spontaneous breathing recovery and extubation. Length of stay in recovery room could also be shortened. An objective surrogate of ventilation is maximal End Tidal CO2, if there is no alveolo-capillary gradient abnormality (Obesity, Chronic respiratory disease, Cyanogenic heart disease). Thus, this study will compare the percentage of patients who reached a maximum End Tidal CO2 greater than 45mmHg during awakening period in post-anesthesia care unit (PACU) in 2 groups :

* first group ("non-blind group") with capnography monitoring see by the PACU nurses
* second group ("blind group") with capnography monitoring but PACU nurses cannot see the values Other parameters like the time between ventilator's disconnection and the first ventilatory cycle in spontaneous ventilation, the time between ventilator's disconnection and tracheal extubation or laryngeal mask's withdrawal, the minimal SpO2 reached after tracheal extubation or laryngeal mask withdrawal or the length of stay in PACU are also recorded.

Eligibility Criteria:
Inclusion Criteria:

* Major patients with given written consent
* General anesthesia, induction with Propofol infusion and Target-Controlled Infusion (TCI) remifentanil, relayed with inhaled sevoflurane and TCI remifentanil
* Upper airway control with naso-orotracheal tube or laryngeal mask
* Ventilated normotherm patients in PACU

Exclusion Criteria:

* Minor or pregnant patients
* Obesity with Body Mass Index \> 40 kg/m²
* Chronic respiratory disease with SpO2\<90% in ambiant air
* Cyanogenic heart disease
* Patients under myorelaxant in PACU
Sport Without Injury ProgrammE Floorball

This study evaluates the preventive effect of a neuromuscular training program on injuries in youth floorball players. Half of participants will receive the training program, and half act as control and perform their usual training practices.

The study is a cluster-randomized controlled trial including male and female youth (12-17 years) floorball players. Club is used as cluster unit.

Coaches in the intervention group receive education of the preventive neuromuscular training program Knee Control (Knäkontroll) before the start of the season. Knee Control consists of 6 different exercises, with 4 different variations and 1 pair-exercise, and takes about 10 minutes to complete. In addition, coaches are instructed to perform a 5-minute running warm-up before the Knee Control exercises. Teams are to carry out the intervention at all training sessions, and the 5-minute warm-up also before all matches.

Coaches in the control group carry on their normal training and warm-up routines with their clubs.

Teams are followed for one full season: October 2017 - March 2018. Data registered for the study include exposure to floorball training and matches, and injuries that occur as a result of participation in floorball.

Eligibility Criteria:
Inclusion Criteria:

* Teams with players 12-17 years of age (born 2000-2005)
* Teams who have not used a structured training program aiming to prevent injuries (the Knee Control or similar program) on a regular basis the last year
* Teams who have training at least twice per week

Exclusion Criteria:

-
Algorithm to Control Postprandial, Post Exercise and Night Glucose Excursions in a Portable Closed Loop Format,

In previous studies, the investigators tested the feasibility of a bi-hormonal reactive closed loop system without mealtime announcement. This system for automated control of blood glucose in patients with type 1 diabetes was tested in the clinical research center (APPEL 1 and 2) as well as at the home of the patients (APPEL 3 and 4). After the APPEL 4 study some improvements have been made to the miniaturized prototype to allow patients to operate the system independently and additional risk control measures were included. The main objective of this study is to assess the efficacy of this improved closed loop system.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with diabetes mellitus type 1;
* Treated with SAP or CSII for a minimum of 6 months;
* Willing and able to sign informed consent.

Exclusion Criteria:

* Impaired awareness of hypoglycemia (score ≥ 4) according to Gold and/or Clarke questionnaire;
* BMI \> 35 kg/m2;
* HbA1c \> 97 mmol/mol (=11.0 %);
* Use of heparin, coumarin derivatives or oral corticosteroids;
* Use of acetaminophen during the open loop or closed loop period, as this may influence the sensor glucose measurements;
* Limited ability to see, and to hear or feel alarm signals of the closed loop system;
* Skin condition prohibiting needle insertion;
* Pregnancy and/or breastfeeding;
* Living alone during the night during the closed loop period (the patient may ask someone to stay over temporarily);
* Expected poor connectivity with internet regarding 24/7 tele monitoring;
* Any condition that the local investigator feels would have interfere with trial participation or the evaluation of the results