cyrilzakka/clinical-trials huggingface dataset:
Workplace Interventions Preventing Risky Use of Alcohol and Sick Leave

The aim of this study is to investigate the effectiveness of two workplace interventions (the Riskbruk model and Balance) in reducing risky alcohol consumption, sickness absence and presenteeism. The purpose is to assess whether the Riskbruk model should be implemented in the Norwegian workforce in its entirety, whether the less extensive and costly alternative Balance is sufficient, or if neither one of them show effectiveness compared to usual care.


Eligibility Criteria:
Inclusion Criteria:

* Employees screening positive for at-risk drinking (8+ on the AUDIT)

Exclusion Criteria:

-
Postpartum Fatigue and Pain Versus Nutritional Status, With Epidural Analgesia

The objective of this preliminary observational study is to evaluate, in the patient, a correlation between a food habit and nutritional status score of the parturient and a postpartum fatigue (FSS) and pain (ENA) score on day 1, 3 and 7.

Several studies, focusing on nutrition during pregnancy, show that a healthy diet during pregnancy promotes fetal growth and development and has been associated with lower risks of complications, while unhealthy diets, undernutrition and overeating have been associated with adverse effects. Indeed, the FIGO initiative developed in 2015 a short nutritional questionnaire on adolescent nutrition, preconception and mothers. The FIGO Nutrition Checklist is an acceptable, potentially feasible, and validated clinical practice tool that can identify regular consumption of unhealthy diets or other nutrition and weight-related issues.

Studies have shown that exhaustion, fatigue and pain are commonly experienced by the mother during the postpartum period and can impact daily functioning, mental health and parenting practices.

Currently, the link between nutritional status, eating habits and postpartum pain and fatigue has not yet been clearly studied. Recognizing patients at risk of pain and fatigue, due to their nutritional status, could make it possible to adapt and anticipate their treatment, in particular analgesics, and to consider multidisciplinary management.

The objective of this preliminary observational study is to evaluate, in the patient, a correlation between a score of eating habits and nutritional status of the parturient and a score of fatigue and postpartum pain at D 1, 3. and 7.

After obtaining written consent, 60 patients, having given birth vaginally under an epidural, will be recruited at the maternity ward. The exclusion criteria will be the patient's refusal, the absence of communication in French, the impossibility of giving free and informed consent, surgery under anesthesia during hospitalization.

Questionnaires adapted to assess the nutritional score and the PNNS-GS 2 eating habits of the patients will be completed by the doctor, at the maternity ward on D 1 postpartum. To do this, a typical 24-hour food day will be harvested and then extrapolated to a week. Age, lifestyle, sports habits, vitamin intake before and during pregnancy, weight before and during pregnancy, height, BMI, ASA status, history, duration of labour, complications during pregnancy, complications during childbirth, tears of the perineum, biology data and analgesic treatments will be collected in the medical file. A fatigue and pain score, FSS score and ENA score, respectively at rest and in motion, will be completed by the doctor on D1, D3 and D7 postpartum, either at the maternity ward or by telephone contact. The differences between the scores of days 1, 3 and 7 will be calculated.

Eligibility Criteria:
Inclusion Criteria:

* vaginal delivery under epidural

Exclusion Criteria:

* patient's refusal
* lack of communication in French
* inability to give free and informed consent
* surgery under anesthesia during hospitalization
Effect of an Allergen Vaccine in Patients With Allergic Rhino-Conjunctivitis and Asthma Due to House Dust Mite Allergy

The purpose of the study is to test the safety, tolerability, immunogenicity and clinical efficacy of the combination treatment AllQbG10 in patients with rhino-conjunctivitis and asthma due to house dust mite allergy in a single-center, open-label setting.


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate perennial allergic rhinoconjunctivitis due to sensitization against house dust mites
* Mild asthma
* Females only if non-reproductive or agree to practice an effective and accepted method of contraception

Exclusion Criteria:

* Relevant cardiovascular, renal, pulmonary or endocrine disease
* History of autoimmune disease
* Severe allergies
* History of active infectious disease
* Current diagnosis or history of malignancy
* Relevant neurological or psychiatric disorder
* Pregnancy or lactation
* History of alcohol abuse or other recreational drugs
* Use of an investigational drug within three month before enrolment
* Blood donation within 30 days before enrolment
Effectiveness of a Distance Eduaction Course for Prevention in RSI/WRMD

Repetitive Strain Injuries (RSI) or Work-Related Ostomuscular Disorders (WRMD) are musculoskeletal disorders. Nursing is one of the categories of workers most affected, due to the inherent functions they perform in their daily activities. The objective of this study is to evaluate the effects of a distance education program of prevention in RIS/WRMD on the quality of life of a nursing group.

Repetitive Strain Injury (RSI) or Work-Related Musculoskeletaldisorders (WRMD) are the names given to skeletal muscle disorders that mainly affect the upper limbs, the scapular region and the neck. One of the most affected categories is nursing workers who present health problems inherent to the function they perform in their daily activities. Due to this peculiarity, several studies are focused on the occupational risks of nursing workers in the hospital environment. However, It was not found in the literature studies that suggests strategies to prevent and improve the worker's quality of life. Distance education comes as a differential. It has power in interactive media and collaborative learning beyond self-learning and mass media. This research project proposes to carry out a randomized clinical trial where the intervention group will receive a Prevention Course in RSI/WRMD in the distance education modality and the control group will receive Educational Lectures on Prevention in RSI /WRMD, both groups will be composed by a nursing team from the Clinical Hospital of Porto Alegre.

Eligibility Criteria:
Inclusion Criteria:

* Nurse staff from HCPA
* Male and Female
* Individuals that agree to participate of the distance eduacational course
* Individuals that agree to participate in the research by signing the Term of Free and Clarified Consent

Exclusion Criteria:

* Individuals that do not complete the course
* Individuals that do not agree to participate in the research by signing the Term of Free and Clarified Consent
* Individuals with chronic musculoskeletal injury diagnosed.
The Impact of Aerobic Interval and Inspiratory Muscle Training On Patient Reported Outcome Scores In Individuals With Chronic Constipation

The primary aim of this study will be to determine if the addition of aerobic interval and inspiratory muscle training (IMT) targeted at improving cardiopulmonary-based measures will further improve patient satisfaction scores in individuals with chronic constipation (CC) who report plateau or limited improvements in CC after demonstrating a corrected defecation pattern using anorectal biofeedback training.


Eligibility Criteria:
Inclusion Criteria:

* Adults \>18 years of age
* Complaint of chronic constipation and associated symptoms
* Confirmed pelvic floor muscle dyssynergia
* Willing and able to sign informed consent
* Ability to comply with study guidelines.
* Potential subjects must report two or more of the following: straining during more than 25% of defecations, lumpy or hard stools more than 25% of defecations, sensations of incomplete bowel evacuation more than 25% of defecations, manual maneuvers to facilitate more than 25% of defecations, sensation of anorectal obstruction/blockage more than 25% of defecations, and fewer than 3 small bowel movements per week.

Exclusion Criteria:

* Rectal prolapse greater than grade 2
* Pregnancy
* Cognitive impairments
* History or present cardiac condition that would exclude them from moderate intensity exercise
* Presence of an orthopedic condition with significant severity that the exercise protocol may exacerbate
* Currently receiving additional physical therapy treatment for conditions associated with pelvic floor muscle dysfunction
* Recent surgery within the past 3 months without clearance from a medical doctor
* Medication usage that would interfere with their ability to exercise safely
* Individuals recovering from a confirmed eating disorder or recent unexplained weight loss \>10lbs within one month.
Study of Ipilimumab and Dasatinib Combination Therapy in Patients With Chronic or Accelerated Chronic Myeloid Leukemia

The purpose of the study is to assess the safety of ipilimumab and dasatinib combination therapy in patients with CML


Eligibility Criteria:
Inclusion Criteria:

* Ph+ CML on dasatinib therapy
* Loss of cytogenetic or molecular response while on dasatinib therapy
* On stable dose of dasatinib for a minimum of 12 weeks and with \< 14 day interruption of treatment

Exclusion Criteria:

* Blast crisis CML
* Autoimmune disease
* Uncontrolled or significant cardiovascular disease
A Phase Ib/II Study of SHR-A1811 Injection in Breast Cancer

To evaluate the safety, tolerability and efficacy of SHR-A1811 in combination with pyrotinib or pertuzumab or adebrelimab or albumin-bound paclitaxel in patients with breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Women aged 18 to 75 (inclusive)
2. Breast cancer confirmed by histology or cytology.
3. ECOG score is 0 or 1
4. An expected survival of ≥ 12 weeks
5. At least one measurable lesion according to RECIST v1.1 criteria
6. Have adequate renal and hepatic function
7. Patients voluntarily joined the study and signed informed consent

Exclusion Criteria:

1. Have other malignancies within the past 5 years
2. Active central nervous system metastasis without surgery or radiotherapy
3. Presence with uncontrollable third space effusion
4. Have undergone other anti-tumor treatment within 4 weeks before the first dose
5. Immunosuppressant or systemic hormone therapy was used within 2 weeks prior to the first dose
6. Any active autoimmune disease or a history of autoimmune disease
7. A history of immune deficiency
8. Clinically significant cardiovascular disorders
9. Clinically significant history of lung disease
10. The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I
11. Known hereditary or acquired bleeding tendency
12. Active hepatitis and liver cirrhosis
13. Presence of other serious physical or mental diseases or laboratory abnormalities
Cath Lab Performance Improvement

In 2004, the Cardiac Cath Lab at Children's Healthcare of Atlanta was asked to conduct a Quality Improvement Review examining radiation exposure.

In 2004, the Cardiac Cath Lab at Children's Healthcare of Atlanta was asked to conduct a Quality Improvement Review examining radiation exposure.

To perform radiological procedures with minimal radiation exposure and to ensure safe care during catheterization procedures, we conducted a chart review of all patients requiring fluoroscopy in the lab during the period of January - June, 2004.

• Based on our Retrospective Review, we were able to present Our New Standards to the Cardiac Cath Lab Committee at the end of June, 2004 with the following:

1. Diagnostic procedure time decreased from 45 minutes standard to 30 minutes standard.
2. Intervention and Electrophysiology procedure time reduced from 90 minutes to 45 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Medical charts of all patients requiring fluoroscopy in the cardiac catheterization lab at Children's Healthcare of Atlanta, Egleston,during January - June, 2004.

Exclusion Criteria:

* Those who did not meet inclusion criteria.
Histotripsy (HistoSonics®) for Liver Tumours

Histotripsy is a promising non-invasive technique that uses high-intensity ultrasound waves to disrupt tissue without damaging surrounding structures. It works by using high-intensity ultrasound waves to create microscopic bubbles within the tumour tissue. These bubbles rapidly expand and collapse, generating shock waves that disrupt the tissue. The technique is highly precise and can be targeted to specific areas of the liver, allowing for selective destruction of tumour cells while minimizing damage to healthy tissue. This study will enrol 20 patients with liver tumours (be it primary or secondary liver tumours), monitor their post-operative adverse events, and study the changes in tumour size and volume after treatment. Histotripsy will be performed under general anaesthesia, with real-time monitoring by ultrasound, and deliver high-intensity ultrasound waves in single session or multiple sessions. Similar to other minimal invasive treatments, patients will be admitted 1 day prior, then receive Histotripsy on the next day and stay overnight for observation. Patients will be discharged on the 3rd day if unremarkable. During the hospital stay, blood samplings will be taken for evaluation around 2-4 times in total depending on the length of hospital stay.


Eligibility Criteria:
Inclusion Criteria:

* Fit for general anaesthesia
* Liver tumour size \< 10cm
* Solitary or multifocal
* Primary liver tumour such as hepatocellular carcinoma or intrahepatic cholangiocarcinoma
* Secondary liver tumour such as liver metastasis
* Patients with operable or inoperable liver tumours
* Liver transplant candidates awaiting for liver graft

Exclusion Criteria:

* Refusal to take part in clinical trial
* Child C liver cirrhosis
* Not fit for general anaesthesia
Effects of Lithium on Suicide Prevention in Adolescents and Young Adults With Bipolar Disorder in China

This study aims to use a retrospective cohort approach to explore the impact of lithium carbonate on suicide and self-harm related events among adolescents and young adults with bipolar disorder in China.The primary objective of this study is to investigate the effects of lithium carbonate on suicidal ideation in adolescents and young adults with bipolar disorder in China. Secondary objectives include exploring its effects on preventing suicide attempts, non-suicidal self-injury, and aggressive behaviors in this population.


Eligibility Criteria:
Inclusion Criteria:

-

1 For Lithium group

1. Aged 12-45 years (adolescents 12-17, young adults 18-45).
2. Diagnosed with bipolar disorder using the the Mini-International Neuropsychiatric Interview (M.I.N.I.) (M.I.N.I.; version 5.0) based on Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria.
3. Adolescents diagnosed using the M.I.N.I. Kid version.
4. Lithium medication adherence of at least 80% in the first six months over the past year.
5. Not in an acute phase of illness.
6. Patient or guardian able to participate in assessment interviews.
7. Informed consent signed by participants and guardians (for adolescents).

2 for Non-lithium group

1. Aged 12-45 years (adolescents 12-17, young adults 18-45).
2. Diagnosed with bipolar disorder using the Mini-International Neuropsychiatric Interview (M.I.N.I.; version 5.0) based on DSM-IV criteria.
3. Adolescents diagnosed using the M.I.N.I. Kid version.
4. No lithium use over the past year.
5. Not in an acute phase of illness.
6. Patient or guardian able to participate in assessment interviews.
7. Informed consent signed by participants and guardians (for adolescents).

Exclusion Criteria:

1. Severe physical illness or active substance abuse.
2. Severe cognitive impairments, including developmental delays or dementia.
Trial Comparing Alignment Techniques - RSA of ATTUNE Knee System

The purpose of this study is to compare migration patterns between mechanical and anatomic alignment surgical techniques for the Attune S+ CR-FB knee system using model-based RSA over the first 2 post-operative years.

This is a multi-centre, randomized controlled trial of patients undergoing cruciate-retaining total knee arthroplasty with the Attune S+ fixed bearing TKR system. Patients will be randomized to two study groups:

1. Neutral mechanical alignment;
2. Anatomical alignment.

The principal objective of this study is to compare migration patterns between mechanical and anatomic alignment surgical techniques for the Attune S+ CR-FB knee system using model-based RSA over the first 2 post-operative years.

Secondary objectives include; comparison of 2-year migration values against published thresholds for adequate short-term fixation, comparison of functional and health status of subjects following surgery, comparison of intra-operative soft-tissue releases, incidence of complications and adverse events, and to assess several health economic parameters relating to the surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty
2. Varus knee deformity of 0 to 10 degrees
3. Sufficient ligamentous function to warrant retention of the posterior cruciate ligament
4. Between the ages of 21 and 80 inclusive
5. Patients willing and able to comply with follow-up requirements and self-evaluations
6. Ability to give informed consent

Exclusion Criteria:

1. Active or prior infection
2. Medical condition precluding major surgery
3. Inflammatory arthropathy
4. Prior patellectomy
5. PCL deficiency
6. Major Coronal plane deformity
7. Valgus alignment
8. Bone defects requiring augments, cones and/or stemmed implants
9. Body Mass Index 45 or more
Video-laryngoscopy During Chest Compression

The investigators will compare the success rates and time to successful intubation of endotracheal intubation during simulated pediatric and infant resuscitation with and without chest compression using four different video-laryngoscopes.


Eligibility Criteria:
Inclusion Criteria:

* Give voluntary consent to participate in the study
* Minimum 1 year of work experience in nursing

Exclusion Criteria:

* Not meet the above criteria
* Wrist or low back diseases
Imagery Rescripting in the Treatment of Post Traumatic Stress Disorder (PTSD) Following Early Chronic Interpersonal Trauma

Imagery Rescripting (IR)is a promising treatment for PTSD in adult survivors of early, chronic, interpersonal trauma (e.g. Smucker \& Dancu, 1999). So far, this protocol has not been investigated within a controlled setting with patients with PTSD following early, chronic, interpersonal trauma. The aim of the proposed study is to 1. investigate the efficacy of Imagery Rescripting and 2. check whether the efficacy of Imagery Rescripting can be improved by adding a stabilization phase (Skills training in affective and interpersonal regulation, STAIR) prior to this treatment. In a randomized controlled trial three conditions will be compared:

1. Imagery Rescripting
2. STAIR + Imagery Rescripting
3. Wait-list control


Eligibility Criteria:
Inclusion Criteria:

* a full diagnosis of post-traumatic stress disorder (PTSD) according to DSM-IV
* having experienced repeated or chronic interpersonal trauma by care-takers or authority figures before the age of 15
* between the age of 18 and 65 years
* sufficient fluency of Dutch to complete treatment and research-protocol
* participants using prescribed anti-depressant medication are required to be on a stable dose for at least 6 weeks before the beginning of treatment and remain on this dose throughout the treatment

Exclusion Criteria:

* psychosis
* bipolar disorder
* significant cognitive impairment
* substance dependence
* current use of benzodiazepines
* severe suicidal ideation or life-threatening automutilation
* current trauma or threat
* unstable living circumstances
* antisocial personality disorder
* primary diagnosis of borderline personality disorder
A Randomized Controlled Trial of a Water Protocol for Clients With Thin Liquid Dysphagia

The Purpose of the GF Strong water protocol is to allow clients who have thin liquid dysphagia to drink water under certain specified conditions according to the rules of the water protocol. Water Protocols have been shown to improve client satisfaction, and hydration. We wish to assess this in a randomized, controlled fashion, and this is a pilot project to determine feasibility.

GF Strong water protocol will be used with the study subjects. Control subjects will not receive water protocol. Pre and post measures will include SWAL-QOL, client satisfaction, water and thickened fluid intake, and monitoring for adverse events.

Eligibility Criteria:
Inclusion Criteria:

Potential participants in this study will include all clients aged 19 years and older who are admitted to GF Strong Acquired Brain Injury (ABI) and Neruomusculoskeletal (NMS) and Adolescent and Young Adult (AYA) programs and who have thin liquid dysphagia resulting from a neurological diagnosis. The thin liquid dysphagia will be confirmed by a Modified Barium Swallow conducted by a certified speech-language pathologist. Potential participants must be proficient in English in order to complete the questionnaires and capable of understanding the consent form.

Exclusion Criteria:

Clients who present with the following will be excluded: active pneumonia, acute or unstable medical condition, surgery where coughing might rip stitches or cause pain or discomfort, oral dental bacteria or infection that cannot be controlled, poor oral hygiene that cannot be improved with routine care, excessive or uncomfortable coughing during or after intake, severe or uncontrolled GERD, immunosuppressed, or decline participation.