cyrilzakka/clinical-trials huggingface dataset:
Cardiac Dysfunction in Childhood Cancer Survivors

This multicenter, prospective cohort study evaluates early cardiac dysfunction in adult survivors of childhood cancer. The hypothesis of this study is that cardiac dysfunction can be detected earlier when using speckle tracking echocardiography as novel echocardiographic technique compared to conventional echocardiography.

Cardiovascular disease including cardiac dysfunction is the leading non-malignant cause of death in childhood cancer survivors. Early detection of cardiac dysfunction is important to identify those in need for medical intervention to improve outcome. This study invites adult childhood cancer survivors to a clinical appointment to the University Hospital Bern, Switzerland. A detailed, standardized cardiac assessment including conventional and novel echocardiographic techniques (speckle tracking) as well as cardiopulmonary exercise testing is performed. Cardiac dysfunction is evaluated in survivors who have had cardiotoxic cancer therapy with anthracyclines and/or chest radiation (high risk) and in survivors who have had chemotherapy other than anthracyclines (standard risk).

Eligibility Criteria:
This prospective cohort study is nested within the Childhood Cancer Registry (ChCR), a national, population-based cancer registry that includes all children and adolescents in Switzerland who were diagnosed with cancer at age 0-20 years. It includes patients diagnosed with leukemia, lymphoma, central nervous system tumors, and malignant solid tumours or Langerhans cell histiocytosis. Childhood cancer survivors have survived at least 5 years from cancer diagnosis.

Inclusion Criteria:

* Registered in the ChCR
* Formerly treated at the Department of Pediatric Hematology/Oncology of one of five participating centers
* Treated with any chemotherapy and/or chest radiation
* Survived ≥ 5 years since most recent cancer diagnosis (primary cancer, relapse(s), secondary cancer) at time of examination
* Diagnosed at age ≤ 20 years
* ≥ 18 years of age at time of study participation
* Resident in Switzerland
* Written informed consent

Exclusion Criteria:

* Study participants will be excluded if they do not meet the above mentioned inclusion criteria or refuse to participate in the study.
Hybrid Type-1 Effectiveness-Implementation Trial of Motivation Matters!

The goal of this clinical trial is to learn if an interactive mHealth intervention will be effective in helping women with HIV who engage in sex work and are initiating antiretroviral therapy (ART) take their ART regularly as prescribed, effectively reducing their viral load. The main question it aims to answer is:

- Compared to standard of care, will Motivation Matters! (MM!) be significantly more effective at achieving undetectable viral load in women with HIV by month six.

Researchers will compare the undetectable HIV viral load in women who receive individualized text messages (intervention group) in addition to standard care to those who receive standard care alone (control group).

Participants in the intervention group will receive three messages per week in month one, then two messages per week for the six-month intervention period. Participants will be asked to send a brief, standardized reply to each message, indicating that they are doing well or that they have a question or problem. Regardless of study arm, women will receive ART and counseling consistent with Kenyan guidelines.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* Transactional sex in past 12 months
* HIV-positive
* Not currently on ART
* Enrolled in one of the Sex Workers Outreach Program clinics
* Has access to mobile phone
* Willing to receive study text messages
* Able to read or have someone else read

Exclusion Criteria:

* Plans to move away in next 6 months
* Undetectable viral load at baseline
* Pregnant
Metformin as a Chemoprevention Agent in Non-small Cell Lung Cancer

The purpose of this study is to learn whether it is better to receive the drug Metformin with standard of care for lung cancer or just standard of care.

Participants will need to be scheduled to undergo a surgical resection of their lung cancer at the Mayo Clinic in Rochester, Minnesota. They will be asked to provide a blood sample prior to their surgery. Samples of tumor tissue and normal lung tissue will be taken from the samples removed during your lung surgery. The tissue will be used to evaluate DNA. A skin biopsy at the edge of the incision that has already been made will be done during your surgery. We will take the skin and grow skin fibroblasts. Then we will reprogram the skin fibroblasts into induced pluripotent cells. You will be "randomized" into one of the study groups to either take Metformin for 6 months with your standard of care follow up or to receive standard of care follow up.

Eligibility Criteria:
Inclusion Criteria

* Suspected or biopsy proven Stage IA-IIIA lung squamous cell carcinoma (SCC) (must be proven SCC at the time of surgery)
* Medically fit for surgical resection (based on surgeon assessment)
* Current or prior smoker
* Age \> 18 years old
* Both Male and Female
* Willing and able to consent to study, undergo study interventions, and take study drug
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2
* Subject must start Metformin within 90 days of surgery.

Exclusion Criteria

* Currently taking metformin or other diabetic drugs
* Current or previous congestive heart failure, renal failure or liver failure
* Creatinine in Women of 1.4 or greater and Creatinine in Men of 1.5 or greater
* Existing untreated or prior cancer \<5 years from diagnosis
* Received neo-adjuvant platinum-based chemotherapy or targeted therapy
* Receiving adjuvant platinum-based chemotherapy or targeted therapy after surgical resection
Testing an Alternative Therapy for Bulimia Nervosa

This study will compare a new method of treatment for bulimia nervosa (ICAT), integrative cognitive-affective therapy, to the current standard method of treatment, cognitive behavioral therapy (CBT).

Bulimia nervosa (BN) is a disorder characterized by binge eating and compensatory behaviors, such as self-induced vomiting or laxative abuse. It affects 1% to 2% of adolescents and young women, and occurs more rarely in men. People who suffer from BN are also more likely to suffer from other psychiatric disorders, such as anxiety disorders, mood disorders, substance abuse disorders, and personality disorders-those categorized as Axis II in the DSM IV.

Integrative cognitive-affective therapy (ICAT) is a new treatment developed as an alternative to cognitive behavioral therapy (CBT) for treating people with BN. CBT is the standard treatment for BN. ICAT uses some elements from CBT and some elements from therapies used to treat other disorders. Some elements of ICAT are also used to treat substance abuse disorders, depression, and personality disorders. This study will compare the effectiveness of ICAT and CBT in treating BN.

Participants in this study, who must have BN symptoms, will be randomly assigned to receive either CBT or ICAT treatment. Participation in this study will last 18 weeks for participants assigned to receive CBT and 16 weeks for participants assigned to receive ICAT. Both treatments will consist of 20 individual therapy sessions lasting 50 minutes. Additionally, participants receiving ICAT will receive personal digital assistant (PDA) devices installed with therapeutic modules. Use of these modules will be unlimited during the period of ICAT treatment and will be recorded at study visits. Over the course of 2 screening visits, participants will complete questionnaires, undergo clinical interviews, and go through a medical screening that involves a blood test of electrolytes and a urine test for pregnancy. Each screening visit will take 2 to 3 hours. At the end of treatment and 4 months after treatment completion, participants will undergo 2 assessments, both of which will include 2 hours of interviews and questionnaires. During these assessments researchers will evaluate weight; eating behavior; and associated problems with mood, anxiety, obsessive-compulsive symptoms, self-concept, social adjustment, and other areas of psychosocial functioning.

Eligibility Criteria:
Inclusion Criteria:

* Bulimia nervosa, as defined by DSM-IV, or bulimic symptoms, as defined as purging episodes (with objective or subjective binge eating) that occur at least once per week for the past 3 months

Exclusion Criteria:

* Past or current diagnosis of psychosis or bipolar disorder
* Inability to read English
* Medical instability, including electrolyte abnormalities
* Psychotherapy or pharmacotherapy initiated within 6 weeks of study entry
* Pregnant or lactating
* Drug or alcohol dependence in the past 6 months or drug or alcohol abuse in the past 6 weeks
* Severe cognitive impairment or mental retardation
Sleep and Cytokines During Acute Diverticulitis

The purpose of this study is to investigate sleep disturbances during Acute uncomplicated diverticulitis by polysomnography. The investigators hypothesis is the inflammation causes REM(rapid eye movement)-sleep reduction and this is correlated with plasma cytokine levels.

An increasing number of experimental studies have showed that inflammation can induce disturbances in sleep architecture, mediated by cytokines. Sleep is important both in health and disease processes and can affect recovery, morbidity and mortality.

Studies have been done on sleep disturbances after major and minor GI-surgery but never in relation to none surgical inflammatory diseases, namely acute diverticulitis.

This study will investigate sleep architecture by Polysomnography and inflammation by levels of pro inflammatory cytokines in plasma.

Following methods will be applied

Device: Polysomnograph - Embla Titanium (Natus Medical Incorporated, USA)

Procedure: Plasma cytokines (IL-2, IL-6 and TNF(tumor necrosis factor-alfa)

Procedure: Plasma CRP(C reactive protein) and leukocytes

Eligibility Criteria:
Inclusion Criteria:

* CT-verified diverticulitis patients managed by antibiotic treatment at Herlev Hospital
* Pain and fever occurred less than 72 hours prior to the admission
* ASA (American Society of Anesthesiologists) score I to III

Exclusion Criteria:

* Surgical intervention needed
* Complicated diverticulitis
* Complications in relation to diverticulitis
* Pain and fever occurred more than 72 hours prior to the admission
* In anticoagulant treatment and heart rate control treatment
* Known Autoimmune disease
* Known medically treated sleep-disorder (insomnia, restless legs etc.) and sleep apnea
* Shift-work or jetlag
* Daily use of opioid, psychopharmaca, opioids or anxiolytics (including Hypnotics)
* Known psychiatry conditions in treatment with psychopharmaca
* Daily alcohol intake of more than 5 units or drug abuse
* Missing written consent
* Diabetes Mellitus
* Predicted bad compliance
* Pregnant or breast-feeding
* Urine or fecal incontinence
* Severe kidney disease
* Current cancer
A Study of ND0801 in Attention Deficit/Hyperactivity Disorder (ADHD)

A multicenter, open label, escalating dose study to assess the tolerability and the safety and to explore the efficacy and the pharmacokinetics of ND0801 in adult patients with attention deficit/hyperactivity disorder (ADHD).


Eligibility Criteria:
Inclusion Criteria:

* Outpatients.
* Men and women 18-55 years of age.
* Primary DSM-IV diagnosis of adult ADHD confirmed by senior physician
* Capable and willing to provide informed consent
* Able to adhere to the treatment schedule, and withdrawal of ongoing pharmacotherapy for the treatment of ADHD prior to the beginning of the study treatment and during the study drug treatment.
* Subjects must be able to read, hear, write and speak the local language.
* Subject has signed a written informed consent to participate in the study.

Exclusion Criteria:

* Unstable or significant medical disorder.
* Current (within 12 months of baseline) primary or secondary depression.
* History of substance abuse or dependence within the past 6 months
* Any psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features
* Bipolar disorder
* Eating disorder
* Obsessive compulsive disorder
* Post-traumatic stress disorder
* Current generalized anxiety disorder
* Presence of a personality disorder
* Individuals with a significant other neurological disorder.
* Use of any investigational drug within 4 weeks of the randomization visit
* Known or suspected pregnancy
* Women who are breast-feeding
* Women of childbearing potential and not using a medically accepted form of contraception
Kinematical and Muscular Fatigue in Swimmers

During a submaximal task, gradual muscle fatigue occurs, which inevitably results in a decline in performance (mechanical failure). Elite athletes are known to employ unconscious compensatory strategies during fatiguing submaximal tasks in an attempt to delay the onset of mechanical failure as long as possible.

The purpose of this study was to gain valuable insight into the strategies used by elite swimmers to cope with mechanical failure. Twenty-two swimmers were subjected to a swim test consisting of swimming as long as possible at a predetermined and controlled pace. A light strip positioned at the bottom of the pool allows athletes to get feedback on which gait to keep. The kinematics (stroke rate, stroke length, and efficiency index) and electrical activity of 10 muscle groups were analyzed and compared at the beginning of the test (non-fatiguing conditions), just before the athlete lost the ability to maintain the predetermined pace (pre-mechanical failure), and after the athlete lost the ability to maintain the pace (mechanical failure). It is hypothesized that as fatigue becomes more pronounced and the point of inability to maintain a predetermined speed is approached, increased EMG activity will occur in key muscles while other muscle groups may show more obvious signs of fatigue. In addition, changes in the rhythm and coordination of upper limb movements may occur.


Eligibility Criteria:
Inclusion Criteria:

1. Middle- or long-distance swimmer specializing in front crawl
2. At least 3 years of experience in international competition
3. Daily use of flashing light for pace control in aerobic, anaerobic threshold and maximum oxygen consumption training.

Exclusion Criteria:

1) Presence of muscle pain or soreness that could prevent the athlete from performing at their best
Lunch Time Insulin Injection by School Nurse for Poorly Controlled Diabetes

We hypothesize that checking blood sugar and taking long and short acting insulin before lunch at school may improve overall blood sugar control, grades, and decreases school absences in children and teens with poorly controlled T1DM.

The Diabetes Control and Complications Trial (DCCT), for type 1Diabetes (T1DM), showed the importance of intensified diabetes control in helping reduce complications associated with poorly controlled diabetes. However, adolescents with T1DM continue to be a high-risk population due to the difficulties in coping with the physical, emotional, and social demands associated with managing diabetes themselves.

We propose to use the school nurse to help with lunchtime blood sugar monitoring (BSM) and with a lunchtime insulin injection. We want to see if this will improve blood sugar control, improve school grades, and decrease absences from school in adolescents with poorly controlled diabetes. Subjects will receive 12 weeks of this treatment to see if they will have improved glucose control. We hope to improve blood sugar control, school grades and decrease absences from school in teens with poorly controlled diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Child with T1DM for at least 1 year
* Age 10-19 years
* Have a Hgb A1C greater than or equal to 9.0% but less than or equal 13.9% for at least 6 months.
* School must have a school nurse

Exclusion Criteria:

* Child who has Type 2 diabetes
* Subject receiving home schooling
Attitudes to Gynae Oncology Care Location - GRACEFUL

Gynaecological oncology (cancer) place of care is often based on evolution of services, along historical professional boundaries, rather than user needs or preferences. The investigators aim to gather views of patients in the United Kingdom (UK) on their preferred place of care for investigation, treatment and follow-up of gynaecological cancer. An initial scoping review found no previous work in this area. Pilot work, performed to inform local re-organisation of services, found that 53% of participants were somewhat or very unhappy to have care co-located with O\&G services. Specifically, two key themes were identified through content analysis of free-text comments: "environment and getting this right is vital"; and "our cancer should be the priority".

However, via a BGCS survey, the investigator found that healthcare professionals (HCPs) underestimated strong patient preferences. Of those who see patients within O\&G services, only 50% said patients were seen at separate times/locations from obstetric patients. The investigators want to expand on these pilot data to better understand how to design services that better meet our patients' needs. The investigators will conduct a survey to ascertain service users' attitudes to location of services, collecting quantitative data \& qualitative data, including opportunities for feedback in free text. The investigator will conduct analysis using standard statistical methods \& content analysis of free-text responses. Submissions will be anonymous \& no identifiable data will be collected routinely, unless volunteered by the respondent. The investigator will ask a subset of \~30 participants to undertake a telephone/virtual-based semi-structured interview to further explore understanding on attitudes to location of care more generally. A topic guide will be developed, informed by the Theoretical Framework of Acceptability. Interviews will be audio-recorded with consent, transcribed verbatim \& anonymised. The anonymised transcripts will be analysed using a form of Thematic Analysis. These findings should help to shape future health care service sensitive to patient need.


Eligibility Criteria:
Inclusion Criteria:

- Female Aged 18 or over Able to give informed consent Have been referred to secondary care with a suspected gynaecological cancer, or have previously been diagnosed with a gynaecological malignancy

Exclusion Criteria:

- Male Unable to give informed consent
Mobile Chat Messaging for Smoking Relapse Prevention

Most smokers return to smoking (relapse) after making a quit attempt, but evidence of effective intervention to prevent relapse is scarce. Taking advantage of recent advances in mobile technologies, this study aims to evaluate the effectiveness of a mobile chat messaging-based relapse prevention intervention in promoting successful quitting in people who recently quit smoking (recent abstainers) using a randomised controlled trial design.

Most smokers who made quit attempts and achieved short-term abstinence return to smoking (relapse) over time, even when aided by effective smoking cessation treatment. Since relapse mostly occurred in the first 4 weeks of abstinence, relapse prevention in the early phase of abstinence could potentially boost long-term abstinence. Several behavioural interventions for smoking relapse prevention have been proposed and tested in RCTs. Yet, a 2019 Cochrane review did not find traditional approaches, including self-help materials, telephone counselling and group therapy, effective in increasing long-term abstinence at 6 months or longer.

The widespread use of mobile devices has provided a highly accessible and scalable means for novel behavioural interventions for smoking cessation. A formative qualitative study in current smokers conducted by the investigators showed that mobile chat messaging is a feasible and acceptable platform for delivering smoking cessation support. A subsequent cluster randomised controlled trial on 1148 smokers found that mobile chat messaging combined with brief intervention was effective in increasing biochemically validated abstinence at 6 months. Nonetheless, whether mobile chat messaging could prevent relapse in recent abstainers has remained untested.

The investigators did a pilot trial to confirm the feasibility and acceptability of mobile chat messaging for relapse prevention in recent abstainers. This study aims to evaluate the effectiveness of mobile chat messaging relapse prevention intervention in promoting abstinence in recent abstainers.

Eligibility Criteria:
Inclusion Criteria:

* Hong Kong residents aged 18 years or above
* Own a smartphone with WhatsApp installed
* Enrolled in a smoking cessation program under Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation
* Smoked daily before the present quit attempt
* Abstained from smoking for 3 to 30 days

Exclusion Criteria:

* Diagnosed with a mental disease or on regular psychotropic drugs
* Participating in other ongoing smoking cessation studies
Refined Nursing in Rehabilitation Training

This study is to explore the clinical effect of refined nursing in rehabilitation training for patients with brain injury during the recovery period. Patients in the control group were provided with routine nursing intervention, while patients in the study group adopted a nursing mode based on the concept of refinement treatment. Comparison was made in terms of the Glasgow Coma Scale (GCS) score, cognitive function score, functional independence score, nursing satisfaction, and incidence of complications.

This study is to explore the clinical effect of refined nursing in rehabilitation training for patients with brain injury during the recovery period. The subjects of the study were 96 patients with severe traumatic brain injury (TBI). According to the order of visits, there were 48 patients in the study group and the control group, respectively.Patients in the control group were provided with routine nursing intervention, while patients in the study group adopted a nursing mode based on the concept of refinement treatment. Comparison was made in terms of the Glasgow Coma Scale (GCS) score, cognitive function score, functional independence score, nursing satisfaction, and incidence of complications.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with severe TBI through imaging examinations such as head CT and magnetic resonance imaging
* patients with surgical indications
* patients with Glasgow Coma Scale (GCS) ≤8 points
* patients with complete clinical data
* patients with written informed consent provided by family members

Exclusion Criteria:

* patients with organic lesions of major organs such as liver and kidney
* patients with contraindications for surgery
* patients with primary diseases such as cerebral hemorrhage and cerebral infarction
* patients with combined or multiple injuries
* patients with respiratory failure
* patients whose family members had cognitive impairment or abnormal mental behaviors
Suction Drain Versus the Use of Adaptive Skin Sutures After Mastectomy ± Axillary Lymphadenectomy; a Prospective Randomised Study

The objective of this prospective randomized study is to perform qualitative and quantitative comparisons between the insertion of traditional suction drains (Arm: Suction drain) versus the application of absorbable adaptive sutures (Arm: Adaptive suture) following simplex mastectomy or modified radical mastectomy in the light of the total volume of withdrawn serum from wound cavity, the extent of early postoperative analgesic requirements and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* female patients with primary unilateral, stage 0, I or II, T3N1M0 breast cancer necessitating simple or modified radical mastectomy

Exclusion Criteria:

* age above 75 years and bad general state
* pregnancy
* autoimmune disease
* non-radical excision
* mastitis carcinomatosis
* lymphangitis carcinomatosis
* wound infection necessitating treatment