cyrilzakka/clinical-trials huggingface dataset:
Evaluation of a Video-Based Media Series to Promote Effective Parenting

Researchers are developing and experimentally evaluating two variants of a 10-episode, brief (12 minutes per episode), infotainment-style television series targeted at parenting practices, to determine the potential value of television for bringing evidence-based parenting practices to parents. The study compares an "information-only" version of the television series against an "enhanced" version that is designed to actively promote parents' adoption of the targeted strategies. Both versions of the series are compared against a waitlist control group. The media series is derived from the Triple P Positive Parenting Program.

The mass media, and television in particular, hold significant potential as part of a population-wide strategy for bringing evidence-based parenting practices to a broad range of parents experiencing challenges raising their children. The potential of television for affecting parenting has received very little research attention, however; thus, little is known about how media messages to affect parenting practices might be optimally designed. This study will develop and experimentally evaluate two variants of a 10-episode, brief (12 minutes per episode), infotainment-style television series targeted at parenting practices, derived from the Triple P-Positive Parenting Program (Sanders, 1999). A sample of 300 families of children ages 3-6 years with somewhat elevated disruptive behavior problems will be randomized to (a) receive a standard "information-only" version of the series that includes only modeling and demonstration of target parenting skills, (b) receive an enhanced "behavior activation" version of the series designed to actively promote parental behavior change, through elements addressing attributions, self-efficacy and expectancies, social support, and emotional reactivity, or (c) a waitlist control group. Measures of parents' parenting practices, cognitions, affect, and social support, and children's disruptive behavior problems, will be obtained at baseline, post-intervention, and 6-month follow-up. The relative efficacy of the standard and enhanced versions of the Triple P Media Series in improving these outcomes will be examined, as well as moderators of these effects, such as baseline level of behavior problems and parental stress. This study will further our understanding of the potential value of television programming for improving parenting practices.

Eligibility Criteria:
Inclusion Criteria:

* parent(s) living with a child 3 to 6 years old
* child scores 1 or more standard deviations above the mean on the Eyberg Child Behavior Inventory
* English speaking
* parent at least 20 years old

Exclusion Criteria:

* currently receiving any other structured parenting intervention (home visits, parenting classes, individual parent training, family therapy)
* father-only households
Clinical Decision Tree Analysis of Hemodialysis Arteriovenous Access Choices and Creations - a Multiple-center Retrospective Cohort Study

Our study aim was to utilize a decision tree analysis (DTA) model to gain insight into the decision-making process within a multiple-center cohort.

Scientific research focuses on limited parameters, aims to confirm hypotheses, and has minor uncertainties. In contrast, medical decisions involve many unknowns. Physicians must use all available knowledge to make the best decisions. However, decision-making can become unpredictable when limited evidence exists, leading to non-reproducible outcomes.

According to clinical guidelines, patients who need pre-kidney replacement therapy (pre-KRT) and opt for hemodialysis (HD) with a reasonable life expectancy should have arteriovenous (AV) access created. Nevertheless, constructing an AVF has limitations. \[Additionally, the maturation rate of AVF is suboptimal. Therefore, after careful consideration of the patient's end-stage kidney disease (ESKD) life plan, the suggested order of AV access types and locations starts a native distal forearm radiocephalic AVF, followed by a native proximal forearm AVF, a forearm arteriovenous graft (AVG), then an upper arm AVG creation.\[Lok et al., 2020\] However, the decision-making process for selecting hemodialysis access is shared between patients, physicians, and the surgeon's discretion.

Therefore, clinical kidney practice requires effective decision-making to address ESKD life plan and AV access concerns while minimizing harm. Decision analysis models can bridge the gap between research and decision-making. Our study aim was to utilize a decision tree analysis (DTA) model to gain insight into the decision-making process within a multiple-center cohort.

Eligibility Criteria:
Inclusion Criteria:

- adult patients between the ages of 18 and 80 who were referred for primary hemodialysis (HD) AV access creation. We included those in the pre-kidney replacement therapy (pre-KRT) stage and those who in the early end-stage kidney disease (ESKD) urgently started HD without sufficient time to plan for AV access

Exclusion Criteria:

- patients who underwent a secondary AV access surgery, like a transposed radiobasilic AVF or a revision of AVG.
Echocardiographic Assessment and CLInical imPlication of Functional tricuSpid rEgurgitation in Heart Failure With Reduced or Preserved Ejection Fraction

Purpose Functional tricuspid regurgitation (FTR) has been shown to be associated with increased morbidity and mortality in several clinical conditions, including heart failure (HF) with reduced left ventricular ejection fraction as well as pulmonary arterial hypertension (PAH). We have designed a study aiming at: characterizing the echocardiographic morphology of the tricuspid valve apparatus and the pathophysiology of FTR in heart failure with reduced, mid-range or preserved left ventricular ejection fraction (HFrEF, HFmrEF, HFpEF) and in PAH patients; correlating the morphologic characteristics of tricuspid valve apparatus with hemodynamic severity of FTR; correlating the severity of FTR with the clinical condition and outcome. Methods The study will be a non-interventional, prospective, international, multicenter, longitudinal study. The minimum number of patients which are expected to be enrolled is 300 HF patients, including HFrEF, HFmrEF and HFpEF patients, whereas 100 PAH patients will serve as control. The patients will be enrolled in 20 centers in Europe, North America and Saudi Arabia. The echocardiographic parameters will be analyzed by the local investigators; a quality control committee will evaluate all data entered in the database to identify potential outliers and a random sample of 10% of cases will be blindly re-analysed in a central core-lab. Conclusions This study has been designed to improve our understanding of pathophysiological mechanisms and clinical relevance of FTR across all HF phenotypes. The results could potentially allow a more appropriate selection of heart failure patients with FTR for tricuspid valve intervention by percutaneous or surgical repair or replacement.


Eligibility Criteria:
Inclusion Criteria:

* consecutive consenting outpatients with HFrEF, HFmrHF, HFpEF or PAH,
* ambulatory visit routinely planned with an echocardiographic examination,
* at the time of the visit at least moderate FTR diagnosed at echocardiography (by visual assessment),
* aged ≥ 18 years old,
* capable to sign an informed consent.

Exclusion Criteria:

* age \< 18 years old,
* congenital heart disease,
* heart failure due to organic mitral or aortic valve disease. No examination will be performed in addition to what is routinely planned for patients' evaluation.
Feasibility Study of a Diary for Allogenic Hematopoietic Stem Cell Transplantation Patients and Families

Allogenic hematopoietic stem cell transplantation is a specific time during hematological disease management for the patients, theirs relatives and the healthcare team. This heavy treatment is most of the time the last possible curative therapy and could cause many side effects such as infectious diseases and graft versus host reaction. The protective isolation is also a source of physical and psychological isolation. Published studies reported depressive syndrome, anxiety symptoms and post-traumatic stress disorders for patients and their families. Since 10 years ago, diaries are used in intensive care unit to limit these symptoms after a coma. In analogy, the diary for the patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long terms consequences. The investigators want to evaluate the psychological impact of a diary on the patients hospitalized for allogenic hematopoetic stem cell transplantation and on their relatives.


Eligibility Criteria:
Inclusion Criteria:

* patient age \> 18 years
* patient hospitalized for an hematopoietic allogenic stem cell transplantation
* patient agreeing to participate

Exclusion Criteria:

* patient not hospitalized for an hematopoietic allogenic stem cell transplantation
Endoscopic Vessel Harvesting During Coronary Bypass Surgery

Conventional open vein harvesting from the legs during coronary artery bypass surgery result in wound complications among 30% of the patients. Endoscopic harvesting decrease the complication rate, but it remains to be shown whether this is also a fact among patient in whom only short segments of veingraft material is needed from the leg. We hypothesise that the rate of wound complications will be reduced and the patient satisfaction will be increased also among patients in whom only short vein segments are endoscopically harvested compared to conventional open vein harvesting.

Conventional open vein harvesting from the legs during coronary artery bypass surgery result in wound complications among 30% of the patients. Endoscopic harvesting decrease the complication rate, but it remains to be shown whether this is also a fact among patient in whom only short segments of veingraft material is needed from the leg. We hypothesise that the rate of wound complications will be reduced and the patient satisfaction will be increased also among patients in whom only short vein segments are endoscopically harvested compared to conventional open vein harvesting.

Preoperative demographic as well ass peri- and postoperative data are collected prospectively at 5-7 days and 1 month postoperatively. Wound complications are registered as well as post operative pain in the wound is evaluated using af visual analogue scale. Patients are evaluating the cosmetic results after wound healing.

Eligibility Criteria:
Inclusion Criteria:

* Elective coronary artery bypass surgery

Exclusion Criteria:

* Leg wounds
* Acute surgery
* Previous vascular surgery
* Combined surgery (valve + coronary)
* Arterial revascularization
Percutaneous Plug-based Arteriotomy Closure Device Use in Minimally Invasive Cardiac Surgery

A single-center prospective study. Patients undergoing minimally invasive cardiac surgery between 2017 and 2022 at the Karolinska University Hospital in Stockholm, Sweden are eligible. Femoral cannulation was performed percutaneously with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device (MANTA; Teleflex/Essential Medical, Malvern, PA). Data regarding preoperative clinical characteristics and operative details were obtained by medical records review.


Eligibility Criteria:
Inclusion Criteria:

* Operated with minimally invasive cardiac surgery between 2017 and 2022 at the Karolinska University Hospital in Stockholm, Sweden, with use of percutaneous femoral cannulation with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device.

Exclusion Criteria:

* None.
Safety Study of Rufinamide Given as an add-on Therapy to Treat Patients With Seizures

This study will evaluate the efficacy and safety of Rufinamide in reducing seizure frequency in subjects with partial seizures not fully controlled despite treatment with 1 to 3 concomitant antiepileptic drugs.


Eligibility Criteria:
Inclusion Criteria:

* Male and Female patients between 12 and 80 years of age
* Dx of epilepsy with partial onset seizures woth or woth out secondarily generalized seizures
* Non controlled partial seizures despite treatment with 2 different AEDs for at least 2 years
* must have 6 seizures during baseline
* current treatment with maximum of 3 AEDs
* stable dose of AED(s)for at least 1 month
* if patient has VNS, must have been implanted 6 months prior to randomization

Exclusion Criteria:

* Participation in any investigational product for at least 1 month prior to visit 1
* Presence of non-motor simple partial seizures only
* presence of generalized epilepsies
* Evidence of clinically significant disease
* Clinically significant ECG
* Psychogenic seizure in previous year
* History of drug/alcohol abuse
* History of suicide attempt
* Multiple drug allergies
* Concomitant felbamate use
* Need for frequent rescue benzodiazepines
* Concomitant use of vigabatrin
* All patients diagnosed with congenital short QT syndrome
Simple Cognitive Task After Trauma

This research study is designed to investigate the effects of a simple cognitive task (a memory cue following by playing the computer game "Tetris") on intrusive memories ("flashbacks") and other symptoms after a traumatic event. Patients presenting to a hospital emergency department soon after a traumatic event will be randomly allocated to either the simple cognitive task intervention or control. Participants will be followed up at one week and one month, and where possible 3 and 6 months. It is predicted that participants given the simple cognitive task intervention will develop fewer intrusive memories and less severe clinical symptoms than those who are not. This will inform the potential future development of a simple technique to prevent distressing psychological symptoms after a traumatic event. Implementation aspects in a new hospital context will also be explored. Patients use their smartphone for part of the intervention in the study.

This is an explorative pilot study, which will guide the design of a future Randomised Controlled Trial. The main aim of the present study is not a statistical significance test, the results will be descriptive, and will include pilot analyses to obtain an estimate of effect size between groups of the current primary outcome measure.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or over
* Experienced or witnessed a traumatic event resulting in admission to the emergency department for example a road traffic accident (as a driver, passenger, motorcyclist, cyclist or pedestrian)
* Met the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM5) criterion A for Post-Traumatic Stress Disorder (PTSD) ("The person was exposed to: death, threatened death, actual or threatened serious injury, or actual or threatened sexual violence" by "Direct exposure" or "Witnessing the trauma") )
* Can be seen in the emergency department within 6 hours after the traumatic event
* Report memory of the accident
* Fluent in Swedish
* Alert and orientated
* Have sufficient physical mobility use the intervention platform (their smartphone) to play a computer game or engage in other smartphone activities at the point of taking informed consent (i.e. sufficient use of hands).
* Willing and able to provide informed consent and complete study procedures
* Willing and able to be contacted following discharge to complete follow-up assessments
* Have access to an internet enabled smartphone
* in addition to point above "can be seen in the emergency department within 6 hours after the traumatic event", from mid May 2019, to also include patients presenting later to the emergency department if still within 72 hours of the event

Exclusion Criteria:

* Loss of consciousness of \> 5 minutes
* Current intoxication
* Report a history of severe mental illness
* Current substance abuse or neurological condition
* Currently suicidal
Effect of a Component of Fish Oil on Exercise-Induced Bronchoconstriction and Airway Inflammation in Asthma

Docosahexaenoic acid (DHA) is a component of fish oil that is known to support a healthy cardiovascular system, maintain brain function, reduce depression, and improve inflammatory diseases. The study hypothesis is that DHA supplementation will diminish exercise-induced bronchoconstriction and airway inflammation as compared to placebo.

To date, fish oil supplementation studies in patients with asthma have used a combination of omega-3 polyunsaturated fatty acids. A study on the specific formula that is most effective in preventing exercise-induced bronchoconstriction (EIB) has yet to be conducted in humans. Nevertheless, it has been shown that a docosahexaenoic acid (DHA) metabolite, protectin D1, is involved in the active resolution of airway inflammation and that its concentration is greater in healthy control subjects' exhaled breath condensates as compared to patients with asthma during a clinical exacerbation. Supplementing asthmatics with DHA could enable an increased availability of protectin D1 to help resolve airway inflammation during an asthma attack. Furthermore, DHA is known to support a healthy cardiovascular system, maintain brain function, and reduce depression in addition to alleviating inflammatory diseases. Thus, pure DHA supplementation could help patients manage their asthma while providing for their overall health.

The main aim of this study is to determine whether pure DHA can attenuate EIB and airway inflammation in adults with asthma. It is hypothesized that DHA supplementation will diminish EIB and airway inflammation compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of asthma, based on medication use as well as history and symptoms as outlined in the NHLBI Guidelines for the Diagnosis and Management of Asthma
* Diagnosis of EIB, based on a ≥10% fall in FEV1, a measure of lung function, after dry air eucapnic voluntary hyperventilation (EVH), a simulated exercise challenge
* Not currently taking asthma maintenance medication or physician approval to discontinue current asthma medication for the duration of the study
* Not currently taking any fish oil supplements above the level recommended for adequate intake (if currently taking supplements, can participate if the subject stops taking the supplements for 2 weeks before starting the study and throughout the study)
* Agree to limit fish consumption to 1 fish meal per week throughout the study

Exclusion Criteria:

* Post-EVH FEV1 (the amount of air blown out in the first second of a forced exhalation) decreases by more than 50% compared to the subject's resting FEV1 at the first lab testing session
* Pregnancy
* History of cardiovascular disease, including hyperlipidemia (high cholesterol) and hypertension (high blood pressure)
* History of bleeding disorders or delayed clotting time
* History of diabetes
* History of seizures
* Allergy to fish oil
* Allergy to corn or soy products (placebo is a mixture of corn and soy oil)
Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses

The purpose of this study was to compare the subjective performance of DAILIES TOTAL1® daily disposable contact lenses to that of 1-DAY ACUVUE® TruEye® daily disposable contact lenses.


Eligibility Criteria:
Inclusion Criteria:

* Sign written Informed Consent Document and HIPAA form.
* Be current weekly/monthly replacement contact lens wearer.
* Be willing to not sleep in contact lenses during the study period.
* Require vision correction in both eyes, with a contact lens prescription in protocol-specified power range.
* Have best corrected visual acuity of at least 20/25 in each eye.
* Be willing to wear study lenses for at least 8 hours/day and at least 5 days/week.
* Use re-wetting drops less than once per day and be willing to discontinue use of rewetting drops while wearing the study contact lenses.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Be a neophyte or current wearer of daily disposable lenses.
* Require monovision correction or use multifocal contact lenses.
* Have any systemic or ocular disease or disorder, complicating factor, or structural abnormality that would negatively affect the conduct or outcome of the study.
* Have a history of ocular surgery/trauma within the last 6 months.
* Use topical ocular or systemic antibiotics within 7 days of enrollment.
* Use topical ocular or systemic corticosteroids within 14 days of enrollment, continuing throughout the study.
* Have participated in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
* Have habitually worn contact lenses on an extended wear basis (sleeping in habitual contact lenses for at least 2 nights per week) in the last 3 months prior to enrollment.
* Use re-wetting drops once or more per day.
* Other protocol-defined exclusion criteria may apply.
Exercise and Colon Cancer

Despite the success of surgery and chemotherapy among people with colon cancer, 30-50% of patients develop recurrent disease. Physical activity has emerged as a potential lifestyle intervention to reduce cancer recurrence and improve survival among people with colon cancer (CC). This pilot study aims to identify the dose-response effects of aerobic exercise on molecular and cellular pathways associated with physical activity and CC outcomes among patients with stage II and III CC.


Eligibility Criteria:
Inclusion Criteria:

1. histologically confirmed TNM stage II-III CC;
2. completed surgical resection and adjuvant chemotherapy (if applicable) within 1-24 months before entering the study;
3. ≤120 min/wk of self-reported moderate or vigorous intensity physical activity using the Paffenbarger physical activity questionnaire;
4. age ≥18 years;
5. written physician approval;
6. no additional surgery planned within the 6-month intervention (including colostomy reversal);
7. ability to walk unaided for 6-minutes;
8. no contraindications to exercise using the PA readiness questionnaire (PAR-Q), unless physician approves participation with specific knowledge of this contraindication.

Exclusion Criteria:

1. history of another primary invasive cancer (other than non-melanoma skin-cancer);
2. evidence of metastatic CC (i.e., TNM M1);
3. planning to receive any additional adjuvant chemotherapy;
4. pregnant or breast feeding;
5. unable to provide baseline blood sample;
6. cardiac conditions, including the following:

   1. myocardial infarction or coronary revascularization procedure within prior 3 months;
   2. uncontrolled hypertension (systolic ≥180 mmHg or diastolic ≥100 mmHg);
   3. high-risk or uncontrolled arrhythmias;
   4. clinically significant valvular disease;
   5. decompensated heart failure;
   6. known aortic aneurysm;
7. any other condition that may impede testing of the study hypothesis or make it unsafe to engage in the exercise program (determined by the investigative team).