cyrilzakka/clinical-trials huggingface dataset:
Supporting Women With Breast Cancer to Practice DIBH at Home Before Radiation Therapy

To examine the effect of a preparatory digital tool including a new instruction for deep inspiration breath hold (DIBH), before start of radiation therapy in women diagnosed with left sided breast cancer, compared with usual care.

The following questions will be posted:

* Are there any differences in levels of distress (primary outcome) between the control and intervention group at baseline and over time?
* Are there any differences in preparedness for RT (secondary outcomes) between the control and intervention group at baseline and over time?
* Are there any correlations between Health Literacy (HL) levels (secondary outcome) and levels of distress (primary outcome) in the control and intervention group?
* Are there any differences in objective clinical variables (chest mobility and respiratory movements and planned absorbed dose to the heart) between the control and intervention group before and after the intervention (baseline and at planning CT)?
* Which patterns of practice and use of the application (when, how, how often and for how long) can be discerned from the intervention group?
* Are there any correlations between different levels of practice and use of the digital tool and primary and secondary outcomes?
* How do patients in the different groups (control and intervention group) describe their experience of care and information process during RT with DIBH?
* Are there differences regarding health economic variables in terms of costs and health care usage (e.g., estimated time for planning and conducting computed tomography (CT), number of scheduled CT examinations) and patient effects (e.g. co-morbidities (heart related), sick leave, and quality-adjusted life year (QALYs) between patients in control- or interventions group?
* Are there any differences regarding effects on environmental aspects and costs in the different groups (control and intervention)?

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for the study:

* patients \> 18 years of age
* with a left-sided breast cancer diagnosis or DCIS
* who are to receive RT with DIBH technology
* with curative intention
* preparatory CT visit minimum 7 days to a maximum of 4 weeks
* able to speak and understand good enough Swedish to be able to assimilate content in the mobile app and answer surveys and interview questions
* have access to a smart mobile phone.

Exclusion Criteria:

* patients receiving palliative RT or neoadjuvant chemotherap
* Planning CT starting \< 7 days
* people with some form of orthopedic, rheumatological or neurological injury or disease that limits the possibility of carrying out the intervention.
Positive Psychotherapy in Adolescents on Achievement Motivation

The aim of this study is to determine the effect of success skill development psychoeducation based on Positive Psychotherapy on the achievement motivation of adolescents.

The foundation of positive psychotherapy (PPT) Prof. Dr. It was cast by Nossrat Peseschkian. Psychodynamic approaches, existential-humanistic approaches, cultural therapy approaches and behavioral approaches are used in therapy. Positive Psychotherapy states that people have two basic abilities, namely loving and knowing.

In line with the ability to love, primary abilities (love, modeling, relationship/contact, time, patience, trust, belief/religion, doubt, certainty, sexuality, hope and integrity) are formed; In line with the ability to know, secondary abilities (punctuality, orderliness, cleanliness, obedience, courtesy, honesty, loyalty, justice, hard work/success, frugality and reliability) are formed, which are behavioral categories.

These real abilities develop with family, society, environment and time and become the character of the person, and the degree of whether or not the real abilities are in the person plays a decisive role in both the individual's own mental state and interpersonal relations. The ability to succeed, which is one of the secondary abilities, is extremely important for people to have goals and passions in life.

The two most important components of a successful learning-teaching process are providing learner motivation and ensuring the learner's behavioral, sensory and cognitive participation in this process.

Considering that a significant decrease in achievement motivation is observed especially in adolescents with advancing age, the achievement motivation levels of learners against course processes emerge as an important requirement.

Eligibility Criteria:
Inclusion Criteria:

Being a high school student. Having equipment and internet to attend group sessions. Volunteer to work.

Exclusion Criteria:

Not having the equipment and internet to attend group sessions. Not being willing to work.
Mindfulness Training in Military Spouses

This project aims to contextualize the delivery of mindfulness training for military spouses and evaluate its effectiveness on measures of executive functions and psychological well-being.

In addition to psychological and physical health challenges that military service members face, military deployment is known to have deleterious effects on the entire family unit. The January 2010 issue of the New England Journal of Medicine reported medical data from over 250,000 wives of deployed soldiers. These women suffered from clinically significant levels of anxiety, depression, sleep disturbances, and adjustment disorders. Thus, the psychological profile of military spouses sadly parallels that of the military servicemembers. Unfortunately, the effect of deployment on the psychological health in military spouses is largely unstudied, and very few resilience-building programs are available for military families.

Prior research showed that mindfulness training (MT), as a resilience-building program in civilian and military servicemembers, can effectively protect against degradation in of executive functions (i.e., attention, working memory) and benefit psychological well-being over high-demand intervals. While research evidence mounts that MT is beneficial for service members, there is almost no research examining the impact of MT on military spouses' cognitive functioning and psychological well-being.

The present study aims to investigate if MT may successfully benefit cognitive functioning and psychological well-being in military spouses.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Being in a relationship or married to U.S. Army active-duty member or veteran.

Exclusion Criteria:

* A non-controlled severe medical disease that might interfere with the performance in the study.
* Any other condition that the investigator might deem problematic for the inclusion of the volunteer in a training study of this nature.
Canadian Study of Trandolapril on Blood Pressure in Hypertensive Patients (TRAIL)

The TRAIL study was conducted to examine the effects of escalating doses of an ACE inhibitor, trandolapril, on lowering blood pressure in Stage 1-2 hypertensive patients.


Eligibility Criteria:
Inclusion Criteria:

* Stage 1 or 2 Hypertension

Exclusion Criteria:

* Uncontrolled diabetes
* Subject has a hypersensitivity to ACE inhibitor
Study Evaluating Safety and Tolerability of Escalating Single and Multiple Doses of PIPE-791 and Food Effect in Healthy Volunteers

This study will be conducted in three parts: Part 1 will be a Single Ascending Dose (SAD), Part 2 will be a Multiple Ascending Dose (MAD), and Part 3 will be a selected SAD cohort in a fed state. Safety will be assessed by periodic measurement of vital signs, physical examinations, electrocardiograms, blood laboratory analyses and occurrence of adverse events (AE).

This is a randomized, double-blind study of PIPE-791 or placebo given as single and multiple escalating doses in normal healthy subjects. The study will be conducted in three parts: Part 1 will be a Single Ascending Dose (SAD) study enrolling approximately 48 subjects for a total duration of 6 weeks. Part 2 will be a Multiple Ascending Dose (MAD) study enrolling approximately 32 subjects for a total duration of 7 weeks, and part 3 will be a selected SAD cohort in a fed state to evaluate the effect of food on the bioavailability of PIPE-791, enrolling approximately 8 subjects for a duration of 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male or female between 18 and 55 years of age (inclusive) at the time of signing informed consent.
* Male or female subjects with reproductive potential agree to comply with protocol-approved double barrier contraceptive method 30 days prior to the first dose and up to 90 days post last dose.
* Medically healthy with no clinically significant or relevant abnormalities in medical history, physical exam, vital signs, electrocardiogram (ECG), or laboratory evaluations (hematology, chemistry, and urinalysis) as assessed by the Investigatory.

Exclusion Criteria:

* Has a current or recurrent disease that could affect the investigational medicinal product or affect clinical or laboratory assessments.
* Experienced a significant systemic illness, as judged by the Investigator, within 30 days of the first dose.
* Has a history of a significant medical, including hepatic and/or renal disease as outlined in the protocol, or psychiatric disorder that may require treatment or make the participant unlikely to fully complete the study or increase risk to the participant.
* History of alcohol or other substance abuse within the 12 months prior to the dosing at the discretion of the Investigator.
* Routine alcohol consumption meeting or exceeding protocol limits.
* History of prior malignancy (except adequately treated non-melanoma skin cancer, carcinoma in-situ of the uterine cervix, ductal carcinoma in situ (DCIS), or localized prostate cancer).
* Donated or lost more than 400 mL of blood within 56 days or plasma within 14 days prior to Screening.
* Received an investigational agent within the last 30 days, prior to screening, or five half-lives of the prior investigational agent.
* Use of any prescription medication, over-the-counter medication, vitamin or supplement, herbal or homeopathic preparation within 7 days or 5 half-lives prior to study drug administration, as determined by the Investigator. Hormone replacement therapy and hormonal contraception is permissible throughout the study.
Evaluation of the Structure Modifying Effect of Avocado-Soybean Unsaponifiables in Hip Osteoarthritis

This study aims to assess the long term (three years) ability of ASU (Avocado Soya unsaponifiable) to slow the decrease of radiographic JSW (Joint Space Width) in hip osteoarthritis (OA). This is a randomized, double blind, comparative, parallel group study versus placebo.

Inclusion criteria:

Primary hip OA, fulfilling ACR criteria, patient over 45 y, painful \> 1 year, Lequesne's index \> or equal to 3, with minimum JSW at the target hip \> 1 mm and \< 4 mm on pelvic radiograph.

Primary criterion of efficacy:

The main criterion of efficacy is the change of JSW between baseline and end point. JSW is measured on the narrowest joint on pelvic or target hip X ray by blinded reader.

Randomisation is stratified according JSW at baseline (\< 2,5 mm or \> or equal to 2,5 mm).

Statistical analysis:

The Full Analysis Set (FAS) is defined by patients with at least one baseline value and one post baseline value.

The main analysis is scheduled on FAS using a Missing At Random (MAR)with a multiple model repeated measure (MMRM)to take in account missing value.

SAP (Statistical Analysis Plan) schedule to analyse JSW change as quantitative variable using an ANCOVA and as qualitative variable (progressors defined as JSW loss upper than 0,5 mm) using Mantel Haentzel test.

Eligibility Criteria:
Inclusion Criteria:

* primary OA of hip,
* ACR criteria,
* older than 45 years,
* symptomatic painful \> 1 an,
* Lequesne's index \> or equal to 3,
* JSW between 1 and 4 mm on pelvic radiograph.

Exclusion Criteria:

* secondary OA.
A Study of a Mastoid Device in Subjects With Ménière's Disease

The purpose of this study is to investigate the efficacy of a mastoid treatment device in patients with active Ménière's disease that is not controlled by traditional medical management

This is a single center, randomized, placebo-controlled trial of mastoid oscillation for treatment of Ménière's disease. Eligible subjects will be randomized using a 1:1 allocation to either mastoid oscillation or placebo (oscillator device that provides the same sound but no vibration of the mastoid) received for 30 minutes at four weekly study visits, with efficacy determination via change in frequency and severity of Ménière's symptoms following the final study visit.

Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 18 and older
2. Clinical diagnosis of Ménière's disease, with classical symptoms:

i. Episodic spinning vertigo ii. Fluctuating unilateral low frequency sensorineural hearing loss iii. Tinnitus iv. Aural fullness c. Failure of traditional medical management of Ménière's disease symptoms d. English language skills sufficient to provide informed consent to the study

Exclusion Criteria:

1. Atypical medical history of Ménière's symptoms and questionable Ménière's diagnosis
2. Bilateral Ménière's disease
Gum Acacia and Blood Glucose

This study will provide needed insight on the satiety and blood glucose and l effects of the soluble fiber gum acacia at 20g and 40g doses.

This is a randomized, single-blind, crossover, intervention study testing the satiety and blood glucose effects of the soluble fiber gum acacia.

Eligibility Criteria:
Inclusion Criteria: BMI between 18 and 29 kg/m2

Exclusion Criteria:

* distaste for bagels and cream cheese, orange juice or cheese pizza;
* current smoker;
* restrained eating habits;
* recent weight change;
* any history of disease or significant past medical history;
* are vegetarian;
* do not normally eat breakfast or lunch;
* pregnant or lactating;
* irregular menstrual cycles.
Quantifying Brain Injury on Computed Tomography in Hospitalized Children

Lay Summary:

To evaluate a novel early diagnostic tool for hospitalized children with traumatic brain injury.

The Problem: Children who present with decreased level of consciousness after injury require urgent medical attention determined by the type and the severity of injury. Unfortunately, history and physical findings are often unreliable in the first hours after hospitalization, the period in which urgent management decisions must be made for their treatment.

The Solution: A promising tool developed for measuring detectable evidence of traumatic brain injury on routine brain scans. The tool combines features invisible to the human eye but detectable by computer software with expert knowledge.This study will evaluate how well the tool can perform in a real health care setting. It is believed that it will greatly improve the efficacy and quality of care provided to children after traumatic brain injury.

To evaluate a novel early neuroimaging diagnostic tool for hospitalized children with traumatic brain injury.

This tool is used to detect evidence of traumatic brain injury on routine brain scans. The tool combines features invisible to the human eye but detectable by computer software with expert knowledge.This study will evaluate how well the tool can perform in a real health care setting. It is believed that it will greatly improve the efficacy and quality of care provided to children after traumatic brain injury.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized with TBI
* Age: less than 18 years of age who undergoes routine head CT in the acute period with any severity of injury based on Glasgow Coma Scale score (3 to15).

Exclusion Criteria:

* Non hospitalized
* Non traumatic brain injury
Antiviral Treatment of Chronic Lymphocytic Leukemia

Chronic lymphocytic leukemia (CLL) is increasingly believed to be closely related to chronic stimulation of healthy B-cells. Identification of antigen(s) are relevant for the stimulation of CLL precursor cells is therefore of high interest. The investigators found recently evidence that a herpes virus is involved in this process of stimulation. Consequently, elimination of the antigenic stimulation of leukemic cells by this herpes virus may be expected to reduce or even inhibit propagation of leukemic cells. The investigators hypothesize that inhibition of CMV replication by a short course of antiviral treatment may reduce significantly proliferation rates of leukemic cells. To test this hypothesis, the investigators will treat 20 CLL patients with an antiviral drug for 3 months in a proof-of-concept clinical trial and leukemic cell counts measured before and after antiviral treatment. Antiviral treatment has the potential to treat the disease at its origin and therefore more efficiently than conventional chemotherapeutic regimens.


Eligibility Criteria:
Inclusion Criteria:

* CLL confirmed by immunophenotyping and a relative preponderance of leukemic cells of \>70%
* ANC \>1.500 /µl, Thrombocyte count \>100.000 /µl und hemoglobin value \>11 g/dl
* CLL patients with expression of immunoglobulin heavy chains (IGHV) 1-69 or 3-21
* Seropositive for CMV-specific IgG-antibodies
* Older than 18 years of age
* Written informed consent
* Able to comply with the protocol
* If female, should not be pregnant or be breast-feeding. Women of child-bearing age must have a negative serum pregnancy test within 28days prior to enrollment into the study, if a serum pregnancy test is not performed within 7 days prior first IMP administration; a confirmatory urine test is required.

Exclusion Criteria:

* Indications for treatment of CLL (advanced stages of the disease)
* Having receiving chemotherapy for CLL within 3 months prior to enrollment
* Having received antiviral drugs or i.v. immunoglobulins within 3 months prior to enrollment
* Significant thrombocytopenia (\<100.000/µl) or anemia (Hb \< 11 g/dl)
* Women of child bearing age not using effective contraception
* Pregnant of lactating female (as determined by a positive pregnancy test at screening or within 7 days prior to first IMP administration)
* Known hypersensitivity to drug or its excipients
Natural History of Cardiac and Respiration Function in Patients With Muscular Dystrophies on Home Mechanical Ventilation

Muscular dystrophies are inherited disorders that affect skeletal muscle. Cardiac and respiratory function may be affected in this group of diseases. The investigators sought to analyze the long term cardiac and respiratory function in patients with muscular dystrophies recquiring home mechnaical ventilation .

Muscular dystrophies are neuromuscular disorders with disability and can affect respiratory muscle function and left ventricular function. Medical management of patients with cardiomyopathy relies mainly on angiotensin-converting-enzyme inhibitors and beta blockers. Respiratory management relies on home mechanical ventilation and couph assist.

The investigators aim

* to analyze cardiac and respiratory function over time in patients with muscular dystrophies followed at the home mechanical ventilation unit.
* to determine the long term impact of the home mechanical ventilation on cardiac and respiratory events and to define the predictive factors associated.

Patients will be included retrospectively. Tissue Doppler imaging and Tricuspid annular plane systolic excursion were used for the assessment of the right ventricle. Left ventricular ejection fraction was used for the analysis of the left ventricle. Respiratory function was assessed using the vital capacity, the maximal inspiratory pressure, the maximal expiratory pressure, the peak couph flow rate.

Eligibility Criteria:
Inclusion Criteria:

* Age higher or equal to 18 years
* Duchenne muscular dystrophy
* Becker muscular dystrophy
* Sarcoglycanopathy
* limb girdle muscular dystrophy
* Pompe disease
* Steinert disease
* FSH disease
* Others myopathies

Exclusion Criteria:

* Minor patient
* Sepsis condition
Behavior and Naltrexone Treatment for Alcoholics

The study's purpose is to improve alcoholism treatment by investigating the combined effectiveness of a psychotherapy (Coping Skills Training and Cue Exposure Treatment - CSTCET) with naltrexone in a randomized clinical trial. Individuals will receive 2 weeks of CSTCET or a control treatment as inpatients followed by 12 consecutive weeks of receiving either naltrexone or placebo as outpatients. Followups at 24, 48, and 72 weeks after treatment is completed.


Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for alcohol dependence.

Exclusion Criteria:

* Current diagnosis of dependence on other substances except nicotine.
* A history of psychosis or current psychotic symptoms.
* Current suicidality, homocidality, or psychiatric symptoms that require additional medication.
* Current use of disulfiram (Antabuse).
* Evidence of significant cerebral, renal, thyroid, or cardiac disease.
* History of opioid abuse in the previous year.
* History of cirrhosis, hepatocellular disease, or elevated bilirubin.
* Females who are pregnant, nursing, or not using a reliable method of birth control.
The Vascutek Rapidax™ II Post Market Surveillance Registry

Multicentre, prospective, observational post-market registry. To monitor and collect data on the post-market clinical safety and performance of the Vascutek Rapidax II Vascular Access Graft.

At least 10 patients who have been implanted with a Rapidax II Vascular Access Graft for haemodialysis applications in patients with End Stage Renal Disease (ESRD), who are undergoing or are scheduled to begin haemodialysis and require implant of a prosthetic graft.

Primary End Points:Safety and Performance

* Secondary patency at 6 months post implant (Performance).(access survival until abandonment). The interval from time of implant to abandonment or time of measurement of patency, including intervention to re-establish the functionality of the thrombosed access
* Secondary patency at 12 months post implant (Performance.(access survival until abandonment). The interval from time of implant to abandonment or time of measurement of patency, including intervention to re-establish the functionality of the thrombosed access
* Freedom from device related Serious Adverse Events at 6 and 12 months (Safety)

Secondary End Points: Safety and performance

* Primary patency at 6 months post implant (Performance. (intervention free access survival). The interval from time of implant to any intervention designed to maintain or re-establish patency or to access thrombosis
* Primary patency at 12 months post implant (Performance).(intervention free access survival). The interval from time of implant to any intervention designed to maintain or re-establish patency or to access thrombosis
* Assisted primary patency at 6 months (Performance. (thrombosis free access survival). The interval from time of implant to intervention to maintain patency prior to the occurrence of thrombosis
* Freedom from device related Serious Adverse Events at 6 and 12 months

Eligibility Criteria:
Inclusion Criteria:

1. Subject is ≥ 18 and ≤ 90 years old
2. Subject has a life expectancy of at least 12 months
3. Subject is scheduled to undergo placement of a new straight or loop arm arteriovenous haemodialysis access graft
4. The subject is willing and able to comply with the protocol and associated follow up requirements
5. Subjects must have agreed for their data to be entered into the registry as per the local hospital consent procedure

Exclusion Criteria:

1. Known allergy or sensitivity to ePTFE
2. Subject unwilling or unable to comply with the protocol
3. Life expectancy of less than 1 year