cyrilzakka/clinical-trials huggingface dataset:
The Effect of Laughter Yoga on Nurses' Perceived Stress Burnout and Life Satisfaction During the Pandemic Period

This study aimed to determine the effects of laughter yoga on the perceived stress, burnout and life satisfaction of nurses working actively during the pandemic period. A total of 120 nurses, determined by power analysis, were included in the randomized controlled study. The study included 2 groups. (A group of nurses who have active contact with patients diagnosed with or at risk of covid-19, group B: nurses who have active contact with patients diagnosed with or at risk of covid-19 and participate in laughter yoga practice. Laughter yoga; immune system antibodies and endorphin hormone. It has been proven by experimental studies that there is a connection between the two, that it has a healing effect, that it accelerates the circulatory system as an adverse effect to stress, and that it has a vasodilation effect in the vessels.

The study data were collected by the researchers using online systems with the snowball method due to the pandemic. The inclusion criteria of the study (not having undergone abdominal surgery in the last three months, not having uncontrolled hypertension, not having glaucoma, hernia, epilepsy, not having received a psychiatric diagnosis-treatment, not having received a diagnosis-treatment for sleep problems, having done laughter yoga before) The study consisted of 100 nurses who agreed to participate in the study. Introductory features form consisting of 13 questions, Maslach Burnout Scale and Life Satisfaction Scale, Perceived Stress Scale and life satisfaction scale were used to collect data. Research data were collected in 3 months. During the study, 9 people from the experimental group (8 people did not attend the sessions regularly, 1 person left voluntarily), 10 people from the control group (he left voluntarily) quit the study. Finally, the research was completed with 101 nurses, 51 of whom were in the experimental group and 50 in the control group.

Eligibility Criteria:
Inclusion Criteria:

* Not have undergone abdominal surgery in the past three months
* Uncontrollable hypertension
* Without epilepsy

Exclusion Criteria:

* Antidepressant etc. nurses using drugs
* Not attending sessions regularly
Electrical Stimulation in Patients With Unipolar Major Depression

Double Blinded Randomized Trial of sTNS as adjuvant treatment for Major Unipolar Depressive Disorder. The primary objective is to assess the safety and tolerability of an implantable sTNS of the V1 branch of the trigeminal nerve as an adjunctive treatment for adult patients with the diagnosis of unipolar MDD (Major Depressive Disorder).


Eligibility Criteria:
Inclusion Criteria:

* Outpatients with non-psychotic, unipolar Major Depressive Disorder assessed via the MINI structured interview and legally capacitated to sign the informed consent for participation in the study;
* A score of ≥ 14 on the HAM-D17 with Item 1 (depressed mood) ≥ 2;
* A history of treatment failure with at least 3 adequate trials antidepressants over the previous 6 weeks and less than 6 medications, with no change in antidepressant medication or dose within the previous 6 weeks, and ongoing use of at least one antidepressant (which will continue during participation in the study);
* Patients with suicidal ideation are eligible only if the thoughts of death or of life not being worth living are not accompanied by a plan or intention for self-harm and lack of self-harming attempt in the past 6 months;
* Patients with appropriate support to be compliant with the study protocol.

Exclusion Criteria:

* Patient is mentally or legally incapacitated, unable to give informed consent.
* Patients with psychosis (psychotic depression, schizophrenia, or schizoaffective diagnoses (lifetime); bipolar disorder (lifetime); dementia (lifetime); delirium or any substance abuse disorder within the past 6 months; eating disorder within the past year; obsessive-compulsive disorder (lifetime); post-traumatic stress disorder within the past year; acute risk for suicide or self-injurious behavior. Patients with diagnostic uncertainty or ambiguity (e.g. rule-out pseudo-dementia of depression) will be excluded.
* Patients currently receiving more than six medications for treatment of MDD;
* Patients with exposure to ECT or rTMS or any investigational treatment (for any disorder) within the past 6 months;
* Prior VNS and/or DBS therapy (lifetime);
* Past history of skull fracture; cranial surgery entering the calvarium; space occupying intracranial lesion; stroke, CVA, or TIAs; cerebral aneurysm; Parkinson's or Huntington's disease; or Multiple Sclerosis;
* Current pregnancy, breast feeding, plans to become pregnant during the study, or not using a medically accepted means of contraception;
* Other medical conditions that would increase the risk of infection or surgical related morbidity and/or would affect compliance with the study protocol.
SmokefreeMOM: Reaching Pregnant Smokers With Health Information Via Text Messaging

Despite the great health benefits associated with smoking cessation in pregnancy to both mother and baby, few studies to date have examined the applications of text messaging or other communication technologies for smoking cessation in this population. This project is the first step in developing a new dissemination strategy for reaching pregnant smokers. This research will explore how a state-of -the-art, interactive and intensive, text messaging program, SmokefreeMoms Text, can promote smoking cessation in pregnant smokers. This program may have the potential to reach pregnant smokers who are not currently being reached with traditional smoking cessation services. The study Aims are: 1) to elicit qualitative feedback from pregnant smokers and recent quitters (in the past month) about the concept of SmokefreeMoms, the proposed message protocols in SmokefreeMoms, and the proposed messages in SmokefreeMoms (Phase 1); 2) To develop and pilot test a prototype of SmokefreeMoms which is consistent with Clinical Practice Guidelines (Phase 2), and 3) To conduct a formative evaluation of SmokefreeMoms 1.0 with pregnant smokers and recent quitters (Phase 3). 4) To measure the likelihood that pregnant women who smoke cigarettes will join an SMS program by responding to different types of recruitment messages.


Eligibility Criteria:
Inclusion Criteria:

1. pregnant,
2. smoke or quit in the past 2 weeks,
3. has a data plan or an unlimited text messaging plan on her cell in order to avoid charges for texts,
4. an English speaker.

Exclusion Criteria:

1. not pregnant
2. not currently smoking (or within past 2 weeks)
3. not able to receive text messages
4. not an English speaker
Psychological Interventions to Prevent Late Effects in Breast Cancer

The study aims to investigate whether a combined pre-operative medical hypnosis plus a post-operative internet-based acceptance and commitment intervention are more effective in preventing post-surgical pain and fatigue following breast cancer surgery compared with pre-operative mindfulness plus treatment as usual.

The trial will include 200 patients undergoing breast cancer surgery at Oslo University Hospital. The patients will be randomized into two groups. One group will receive a 20 minute pre-surgical hypnosis session delivered by an experienced clinical psychologist plus a post-surgical internet-based acceptance and commitment intervention. The control group will receive a 20 minute pre-surgical mindfulness session delivered through an audio recording plus treatment as usual. The primary outcomes of the study are quantitative measures of post-surgical pain and fatigue. In addition, relationships between biomarkers of stress and subacute post-surgical pain and fatigue will be analyzed using using blood- and hair samples. The study uses a longitudinal design with baseline measures obtained pre-surgery and follow up measures obtained 3 and 12 months post-surgery.

Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with breast cancer and scheduled for surgery
* Be able to provide informed consent

Exclusion Criteria:

* Insufficient Norwegian speaking or writing skills to participate in the interventions and fill out questionnaires
* Cognitive and psychiatric impairment
* Other serious malignancies
LCS12 Adolescent Study

The study will assess the safety of a sex hormone (levonorgestrel) releasing T-shaped intrauterine contraceptive system in female adolescents under 18 years of age. Approximately 300 generally healthy, post-menarcheal female adolescents with regular menses at the beginning of the study requiring contraception will be enrolled into the study.

Duration of study treatment is approximately 12 months with an option to continue the use of the contraceptive system up to three years if the woman is willing to continue the use after the first 12 months.

The incidence of adverse events over 12 month treatment period will be the main outcome of this study. Also the efficacy (number of pregnancies), discontinuation rate and pharmacokinetics will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* The subject has signed and dated the informed consent form (ICF)
* The subject is female, generally healthy, post-menarcheal, nulliparous or parous, requiring contraception, and is under 18 years of age at the Screening visit
* The subject has regular menstrual cycles without hormonal contraceptive use (at regular intervals of 21-35 days)
* In the opinion of the investigator, the subject has general and uterine conditions suitable for the insertion of levonorgestrel intrauterine contraceptive system (LCS12) (uterine sound depth 6-10 cm)
* Has clinically normal safety laboratory results
* The subject has a normal or clinically insignificant cervical smear (i.e. one that does not require further follow up according to Bethesda or a comparable system)
* The subject is willing and able to attend the scheduled study visits and to comply with the study procedures

Exclusion Criteria:

* Known or suspected pregnancy or is lactating
* Vaginal delivery, cesarean delivery, or abortion less than 6 weeks before Visit 1
* History of ectopic pregnancies
* Infected abortion or postpartum endometritis less than 3 months before Visit 1
* Abnormal uterine bleeding of unknown origin
* Any lower genital tract infection (until successfully treated)
* Acute or history of recurrent pelvic inflammatory disease
* Congenital or acquired uterine anomaly
A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Heart Transplant Patients.

This study will investigate the efficacy and safety of CellCept (1.5-2g/day po), in combination with a standard care regimen of cyclosporine A (trough level 150-200ng/mL) and steroids, in patients receiving a heart transplant. The anticipated time on study treatment is 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* patients receiving their first heart transplant (single organ transplant).

Exclusion Criteria:

* patients with a positive donor-specific cross-match at the time of transplantation;
* patients with any antibody-treated acute rejection;
* known contraindications to treatment with sirolimus;
* history of malignancy, other than excised non-melanoma skin cancer which has not recurred for 2 years.
The Impact of Obesity on Children and Adolescents.

The aim of the study is to investigate the association of obesity with arterial blood pressure, atherosclerosis, target organ damage (heart, arteries, kidney) and insulin resistance in children and young adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Overweight (85th\<BMI\<95th percentile) and obese (BMI\>=95th percentile) children and adolescents
* No medication treatment (apart from bronchodilators, T4 in euthyroid children)
* No severe mental problem
* Parents' and patients' signed consent

Exclusion Criteria:

* Severe chronic or acute cardiac disease or other severe chronic or acute disease
* Any acute inflammation
* Familial dyslipidemia
* Clinical hypothyroidism or other endocrinopathy
* Poor compliance.
A Bioequivalence Study of Daclatasvir Tablets and Bioavailability Studies of Daclatasvir and Asunaprevir

Grps 1, 2, 3 "This study will be testing the performance of ASV and DCV pediatric chewable tablets.

Grp #4 The purpose of this group is to support the marketing authorization of a DCV 90-mg tablet


Eligibility Criteria:
Inclusion Criteria:

1. Signed Written Informed Consent must be obtained from the subjects in accordance with requirements of the study center's Institutional review Board (IRB)/ Institutional Ethics Committee (IEC)
2. Target Population: Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
3. Age and Reproductive Status : Males and females, ages 18 to 49 years, inclusive. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 24 hours prior to the start of study drug and must be using an acceptable method of contraception for 4 weeks prior to study drug administration. Women must not be breastfeeding.

Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for duration of treatment with study drug females must still undergo pregnancy testing as described in this section.

Exclusion Criteria:

1. Medical History and Concurrent Diseases : Any significant acute or chronic medical illness. Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug. Any major surgery within 4 weeks of study drug administration. Any gastrointestinal surgery that could impact upon the absorption of study drug (appendectomies with no complications are allowed at the investigator's discretion). Inability to tolerate oral medication, smokers or recent durg or alcohol abuse and Any other sound medical, psychiatric, and/or social reason as determined by the investigator.
2. Physical and Laboratory Test Findings: Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population, positive urine screen for drugs, positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV-1, -2 antibodies.
3. Allergies and Adverse Drug Reaction : History of allergy to DCV, ASV, Hepatitis C virus (HCV) NS3 protease inhibitors, HCV NS5A replication cofactors, or related compounds.
A Home Visit Program and Perceived Care Burden

The aim of this study was to determine the effect of a home visit program provided to the caregivers of asthmatic patients on the perceived care burden. A randomized controlled trial was used. The sample consisted of 30 participants in the intervention group and 30 participants in the control group. A home visit program including education and counseling was applied to participants in the intervention group.

The aim of this study was to determine the effect of a home visit program provided to the caregivers of asthmatic patients on the perceived care burden. A randomized controlled trial was used. The sample consisted of 30 participants in the intervention group and 30 participants in the control group. A home visit program including education and counseling was applied to participants in the intervention group. A total of five home visits over three months were performed. Data were collected by a personal information form, and the Zarit Caregiver Burden Scale (ZCBS).

Eligibility Criteria:
Inclusion Criteria:

* giving care to a patient who was poorly controlled or uncontrolled asthma
* giving care to a patient who used an inhaler
* age 18 or over
* volunteering to participate to the study

Exclusion Criteria:

* having a disease with a neuro-psychiatric diagnosis
* having vision and hearing problems
Efficacy, Safety and Cost-effectiveness of a Sequential Therapy With RV4104A Ointment, Ciclopiroxolamine Cream and Ciclopirox Film-forming Solution Compared With Amorolfine Nail Lacquer in Dermatophytic Onychomycosis

The purpose of the study is to evaluate and compare the efficacy of the sequential association RV4104A ointment followed by ciclopiroxolamine 1% cream and ciclopirox 8% film-forming solution versus amorolfine 5% nail lacquer alone in the treatment of patients with dermatophytic onychomycosis (toenail) without matrix involvement.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of distal-lateral or lateral subungual onychomycosis of one great toenail (the target nail) without matrix involvement
* Target nail plate showing between 25% and 60% of clinically infected area
* Patient must have at least 2 mm of unaffected proximal target nail area
* Target nail infection due exclusively to a dermatophyte (from positive fungal culture as reported by the central mycological laboratory)
* Female patient of childbearing potential must use an efficient contraceptive method for at least 2 months prior to screening visit
* Female patient of childbearing potential must have a negative urinary pregnancy test at the screening visit

Exclusion Criteria:

* Patient with more than 3 affected nails
* Patient with onychomycosis with matrix involvement
* Patient with psoriasis, lichen planus or other abnormalities that could result in clinically abnormal toenail(s)
* Patient with moccasin-type tinea pedis
* Patient who has received systemic antifungal therapy or any topical antifungal therapy applied to the toenails within 3 months prior to screening visit
* Patient with known hypersensitivity to investigational products' ingredient(s)
* Patient who is currently participating or who has participated in another clinical study within 4 weeks prior to screening visit
Acupuncture to Reduce Chemotherapy-induced Peripheral Neuropathy Severity During Neoadjuvant or Adjuvant Weekly Paclitaxel Chemotherapy in Breast Cancer Patients

The purpose of this study is to find out the effects of acupuncture on reducing nerve damage.

Acupuncture is a medical technique of inserting very thin needles into the "energy points" on the body with the aim to restore health and well-being. It has been used widely to treat pain, such as lower back pain and joint pain. In this study the investigators will assess if acupuncture can be used to ease the pain, tingling and numbness that may be caused by chemotherapy and improve quality of life during chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

Screening Phase:

* Age 21 or older.
* Histologically proven stage I-III carcinoma of the breast.
* Plan to receive adjuvant or neoadjuvant chemotherapy that includes weekly paclitaxel.
* Eastern Cooperative Oncology Group performance status 0-2 (see Appendix B).
* The patient is aware of the nature of his/her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form.
* Proficiency in English with the ability to speak and read English.

Exclusion Criteria:

* Known metastatic (stage IV) breast cancer involvement.
* Pre-existing peripheral neuropathy within 28 days of screening consent
* Currently taking anti-neuropathy medication such as gabapentin, pregabalin, duloxetine, or glutamine.

Intervention Phase:

* Age 21 or older.
* Histologically proven stage I-III carcinoma of the breast.
* Receiving adjuvant or neoadjuvant chemotherapy that includes a taxane.
* Eastern Cooperative Oncology Group performance status 0-2
* The patient is aware of the nature of his/her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form.
* Proficiency in English with the ability to speak and read English
* While on neurotoxic chemotherapy, has developed NCI-CTC grade 2 CIPN

Exclusion Criteria:

* Known metastatic (stage IV) breast cancer involvement.
* Pre-existing peripheral neuropathy within 28 days of screening consent.
* Currently taking anti-neuropathy medication such as gabapentin, pregabalin, duloxetine, or glutamine.
Urokinase Like Plasminogen Activator Levels in Patients Undergoing Bronchoscopy

Some of the risk factors for bleeding following bronchoscopy is having a malignancy or an immunocompromised state. The etiology of this remains uncertain. The investigators suspect that individuals with malignancy have abnormalities involving certain factors that influence the coagulation pathway.

The investigators plan to measure these factors prior to and after bronchoscopy.

This is a prospective observational study looking at some coagulation factors in individuals with lung cancer. We are looking at BAL and plasma. We would like to see if there is a difference in the levels and if this is the reason behind the higher incidence of hemoptysis in patients with lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* Any patient scheduled to undergo bronchoscopy

Exclusion Criteria:

* Patients with evidence of coagulopathy either iatrogenic or the result of disease process - coagulopathy defined as elevated prothrombin time, activated partial thromboplastin time or platelet count less than 100,000
* Patients not scheduled to undergo bronchoalveolar lavage (BAL)