cyrilzakka/clinical-trials huggingface dataset:
Assessment of Validity and Reliability of the Turkish Version of the Quality of Life and Related Events Assessment Scale for Pacemaker Patients

Cardiac implantable electronic devices are widely utilized to lower the rates of morbidity and mortality from ventricular tachycardia and ventricular fibrillation, as well as the incidence of sudden cardiac death. Although implantation of these devices increases survival rates, patients may experience acute and chronic complications. These complications include device dislocation and fracture, inappropriate shocks, pocket hematoma, or infection. Furthermore, functional loss in the upper extremity may result from upper extremity restrictions that are applied for an excessively long time in order to ensure proper placement of the device following implantation, or from patients who choose to extend this period on their own initiative out of worry about device failure or dislocation. Patients' quality of life may be negatively impacted by these issues as well as diminished exercise capacity, weariness, and weaker respiratory and peripheral muscles. A quality of life scale called 'The Assessment of Quality of Life and Related Events (AQUAREL)' was developed by Stoffmel et al. for patients using pacemakers. In this study, the validity and reliability study of the Turkish version of the AQAREL Scale will be conducted.


Eligibility Criteria:
Inclusion Criteria:

* Having a pacemaker implant and not having any complications at the last pacemaker check-up,

  * Being in NYHA I-II-III-IV class,
  * Patients with no cooperation problems,
  * Volunteering to participate in the study.

Exclusion Criteria:

* • Patients with insufficient dementia or cognitive impairment due to multiple comorbidities (e.g., recent cerebrovascular accident and/or significant hypotension),

  * Patients with a history of psychiatric illness,
  * Patients with speech, hearing or intellectual disabilities.
Prospective Phase II Study of Rabbit Antithymocyte Globulin (ATG, Thymoglobuline®, Genzyme) With Ciclosporin for Patients With Acquired Aplastic Anaemia

To assess the tolerability and efficacy of rabbit antithymocyte globulin (ATG, Thymoglobuline®) with ciclosporin (CSA) in the first line treatment of patients with acquired severe aplastic anaemia (SAA), and patients with non-severe aplastic anaemia (NSAA) and who are transfusion dependent. To compare the response rate of the combination of rabbit ATG (Thymoglobuline® and CSA from this pilot study with the response rate observed in a series of matched AA patients; treated after 1994 with the combination of horse ATG (Lymphoglobuline®) and CSA; obtained from the EBMT database (comparative study).


Eligibility Criteria:
Inclusion Criteria:

1. To define aplastic anaemia there must be at least two of the following: (1) haemoglobin \< 10g/dl; (2) platelet count \< 50 x 109/l; (3) neutrophil count \< 1.5 x 109/l, and a hypocellular bone marrow on bone marrow biopsy
2. Time from diagnosis to study registration ≤ 6mths
3. No prior treatment except for haemopoietic growth factors given for no more than 4 weeks, and androgens.
4. Age ≥ 16yrs (≥ 18yrs in Germany in accordance with German law), with no upper age limit.

Exclusion criteria:

1. Eligibility for an HLA-matched sibling donor transplant for SAA patients
2. Prior therapy with ATG or CSA
3. Haematopoeitic growth factors more than 4 weeks before study enrollment
4. Diagnosis of Fanconi anaemia, dyskeratosis congenita or congenital bone marrow failure syndrome
5. Evidence of myelodysplastic disease
6. Paroxysmal nocturnal haemoglobinuria with evidence of significant haemolysis, history of PNH associated thrombosis or a PNH clone \> 50% by flow cytometry
7. Diagnosis or previous history of carcinoma (except local cervical, basal cell, squamous cells, or melanoma)
8. Subject is pregnant (e.g. positive HCG test) or is breast feeding
9. Severe uncontrolled infection or unexplained fever \> 38oC
10. Subjects who have hepatic, renal cardiac, metabolic or other concurrent diseases of such severity that life expectancy is less than 3 months
Patient Perceptions and Physician Assessment of Benefits and Risks of Oral Anticoagulation Due to Non-valvular AF

The risk of stroke is markedly elevated in patients with atrial fibrillation (AF). Oral anticoagulation (OAC) is indicated in individuals with moderate and high risk of stroke to the disadvantage of an increased burden from bleeding. Adequate knowledge of this disorder and understanding the benefits and hazards of antithrombotic treatment are essential to incorporate patient´s values and preferences in these decisions. This will further improve acceptance of recommended therapy and augment compliance with OAC.

The objective of this investigation is to compare patient´s perceptions and physician´s assessments of benefits and risks of OAC.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed and ECG-documented non-valvular atrial fibrillation
* New indication for oral anticoagulation (OAC)
* Ability of informed consent

Exclusion Criteria:

* Existing OAC therapy
* Valvular heart disease
* History of valve surgery
ExeRTiOn2- The Weight Gain Prevention Exercise in Renal Transplant Online Study

The primary aim of this trial is to assess the feasibility of a novel online weight gain prevention resource for new kidney transplant recipients at two London transplant clinics. A previous study conducted by the research team titled 'ExeRTiOn' provided usability feedback that led to revisions of this online resource in a purposive sample of kidney transplant recipients (n=11) and transplant multidisciplinary team members (n=6).

This current study aims to recruit a sample of new kidney transplant recipients (n=50) from two transplant sites in London. Participants will be randomized to either the 12-week kidney transplant specific novel online weight gain prevention resource (n=25) or usual care (n=25). All participants will be assessed at baseline, 12 weeks and 12 months. The primary outcome of this study is feasibility (screening, recruitment, randomization, retention, adherence to the intervention and adherence to the study visits). The research team will also assess the ability to collect measures for a definitive study (body weight, body mass index, body composition, quality of life, self-efficacy, fatigue, arterial stiffness and physical function).

A nested qualitative study will capture participant experience at two time points during this 12 month trial. At 3 months semi-structured individual interviews will be conducted in a purposive approximately 6 to 10 of the intervention participants until data saturation is achieved. These interviews will assess the experience of using the online intervention. At 6 months a purposive sample of approximately 16 participants from both groups will complete individual semi-structured interviews to assess the experiences of participating in this trial.

Eligibility Criteria:
Inclusion Criteria:

* age 18 or above
* able to provide written consent
* less than 3 months post kidney transplant
* access to the internet connected computer, tablet, laptop or smartphone
* a body mass index greater than or equal to 18.5 (healthy range)

Exclusion Criteria:

* age \< 18
* current pregnancy
* unstable medication condition such as uncontrolled angina
* participation in a recent structured exercise programme in the last 3 months
* BMI of less than 18.5 (classified as underweight)
* significant cognitive impairment preventing them from engaging with the online resource
* unable to complete the resource in English
Restricted Useful Field View as a Risk Factor in Older Adults

The relationship between Useful Field of Vision (UFOV) and falls taken by the elderly will be investigated. UFOV is a test which measures visual attention. The test has been used in correlating the visual attention in the elderly with their driving safety record. The test is administered using a computer and consists of three parts: a) subject views figures which appear in the center of the computer screen and identified them as quickly as possible; b)the subject has to identify figures in the center of the screen while at the same time point to another symbol which will appear in one of eight places on the outer portion of the screen; c) the third section is similar to the second except while the subject is identifying and pointing there is a background noise.


Eligibility Criteria:
Vision impaired adults at risk for falls
The 400m-walk-test for Stable Coronary Patients

The objective of this project is to clarify and improve the efficiency of the standardized walk-test in Cardiovascular Rehabilitation. The psycho-metric properties of the 400m walk test at a self-selected speed will be evaluated. Such tests, made at a self-selected ("comfortable", "free") speed particularly assess the endurance capacities. The results of the physiological measurements during the tests will be compared with those of TM6min of Test of Fast Walking of 200m (TMR200m) and a maximal treadmill exercise. Stable coronary patients, aged over 55 years old, will be included.

This study should permit a simplification and a better understanding of the clinical-use of walk tests. In the future, two kinds of tests might be proposed with different distances, 1- 200m-fast-walking-test aimed to evaluate the performance closed to the maximum capacity, 2- self-selected-walk-test on a doubled distance (400m) aimed to evaluate the aerobic capacities of the adaptation of the body in response to effort.


Eligibility Criteria:
Inclusion Criteria:

* Patient received enlightened information on research.
* Patient affiliated to healthcare insurance.
* Patients who agreed to participate in the study.
* Patient male or female aged 55 or more.
* Chronic coronary patient who completed his rehabilitation program.
* Patient able to understand simple orders.
* Indication of outpatient rehabilitation in coronary angioplasty + stenting, surgical coronary revascularization (coronary artery bypass), acute coronary syndrome (STEMI or NO STEMI) or stable angina suites.

Exclusion Criteria:

* Patient under guardianship or tutelage
* Arrhythmia or pace maker (making criterion heart rate unusable).
* Congestive heart failure with left ventricular ejection fraction \<45% measured by trans-thoracic echocardiography according to Simpson's method or assay plasma N-terminal pro-brain natriuretic peptide (NT-pro-BNP-3) times the values used in healthy subjects by the analytical laboratory of the University Hospital of Dijon.
* Severe obstructive cardiomyopathy.
* Aortic valve.
* Thrombus intra cavitary.
* Severe pulmonary hypertension (\> 70 mm Hg).
* History of venous thromboembolism in the last 3 months.
* Heart Transplantation.
* Chronic motor impairments associated with neurological (e.g. sequelae of stroke, impaired balance and coordination) or musculoskeletal origin (e.g., osteoarthritis, osteoarthritis), because the secondary functional impairment will limit the ability to work predominantly in relation to the adaptation to stress.
* Severe medical disorder associated to a significantly alteration of the functional capacity (respiratory failure, metabolic disorders such as non-stabilized progressive renal failure) and involving the vital prognosis in the short or medium term (neoplasIC pathology progressive, systemic disease, non-stabilized).
Treating Pregnancy Related Insomnia With Music

This study aims to examine the effects of 4 weeks music listening at bedtime on sleep quality during the third trimester of pregnancy.

50-60% of pregnant women suffer from insomnia during pregnancy. Pregnancy-related insomnia is often neglected due to a lack of suitable and safe treatments. This study aims to evaluate the effectiveness of music compared to sleep hygiene on sleep quality in a population of first-time pregnant women in the final stages of pregnancy. A post pregnancy follow-up will be completed to test if potential effects of the treatment might last into early motherhood (1-3 months postpartum).

Eligibility Criteria:
Inclusion Criteria:

* Female, aged 18 years or above, pregnant non-mothers
* Have a sufficient level of Danish (verbal) to understand and respond to the questions and task instructions
* Pregnant women will be enrolled in gestation week 29.

Exclusion Criteria:

* Postnatal depression, i.e. a score of 12 or above on the EPDS questionnaire
* Comorbid psychiatric disorder (i.e. epilepsy and depression)
* Using sleep medication
* Working more than two night shifts per week
* History of sleep disorders
Study Of Safety, Tolerability And Effects Of PF-05175157 In Adults With Moderate To Severe Acne Vulgaris

This is a 6 week study to characterize the safety, tolerability and effects of PF-05175157 administered for 6 weeks in subjects with moderate to severe acne vulgaris.


Eligibility Criteria:
Inclusion Criteria:

* Males 18 years or older diagnosed with moderate to severe acne vulgaris who are otherwise healthy.
* Normal spirometry at screening (FEV1 and FVC (Forced Vital Capacity)at least 80% predicted).
* Minimum of 20 inflammatory lesions on the face.
* Willing to discontinue other acne treatments prior to and during the study period through follow-up.

Exclusion Criteria:

* Subjects with active nodulocystic acne.
* Subjects unwilling to comply with lifestyle guidelines, commit to study visits, and perform study procedures.
* History of dry eye or other known disease that affects the sclera or cornea.
* History of pulmonary disease or inability to adequately perform testing.
Resilience and Coping in a Rare Skeletal Disease Population to Face Coronavirus (COVID-19) Outbreak Distress: a Longitudinal Study

In the COVID-19 outbreak context, people living with rare diseases have been highly troubled with anxiety, loneliness, and depression. The project evaluates resilience and coping strategies to address pandemic impact by discussion in a dedicated focus group using a web-based platform. The goal is to improve, in a sustainable manner, the coping skills and psychological well-being of children, adolescents, and young adults affected by rare skeletal diseases.

March 11th, 2020, the World Health Organization (WHO) declared the SARS-CoV-2 pandemic accordingly with the spread and size of the infection.

The restrictions implemented by the governments have substantially changed people's lifestyles, facilitating the emergence of emotions such as fear, anxiety, and a sense of loneliness.

The age groups most involved by these burdens have been childhood, adolescence, and young adults. These groups have experienced dramatic changes in their daily life in order the relational, educational, and social networks. Nonetheless, these links outline the ideal environment for the development of resilience and the promotion of coping strategies to face traumatic events.

These lifestyle challenges and their consequences are even more evident in the context of the rare diseases since the outbreak containment measures have emphasized the troubles with which people affected by these conditions are daily forced to confront, in terms of access to care and treatments, resulting in increased stress and anxiety.

The current phase represents a sensitive step for the resumption of the activities in charge of the health and social service aimed at the citizens and especially to people with special needs, such as people suffering from rare diseases.

The pandemic experience has promoted new forms of meeting and contact between individuals using web-based platforms, playing a fundamental role in preserving the community and "sociality" dimensions.

In this scenario, the rare diseases could be an attractive model since the pandemic impinges over their bio-psycho-social characteristics at different levels. Resilience and coping strategies adopted by rare diseases patients could configure as an exemplum to face the psychological distress resulting from anti-pandemic measures, suggesting new approaches of taking charge by health service.

This study evaluates resilience and coping strategies to address pandemic impact by discussion in a dedicated focus group using a web-based platform. The goal is to improve, in a sustainable manner, the coping skills and psychological well-being of children, adolescents, and young adults affected by rare skeletal diseases.

Eligibility Criteria:
Inclusion Criteria:

Clinical and/or molecular diagnosis of Multiple osteochondromas; Clinical and/or molecular diagnosis of Ollier disease/Maffucci syndrome; Clinical and/or molecular diagnosis of Osteogenesis imperfecta; Consent to participate in the study

Exclusion Criteria:

Subject doesn't match the inclusion criteria
Comparative Study of Lung Bioavailability of HFA-Seretide Via Current Spacer Devices in Healthy Volunteers

The purpose of this study is to determine the effect of plastic spacers and breath actuated spacers on respirable drug delivery of combination steroid inhaler (Seretide/Advair) and whether electrostatic charge within plastic spacers has a clinically relevant impact on the inhaled steroid delivery.

Conventional plastic spacers are bulky and can be influenced by electrostatic charge, which can reduce respirable dose delivery especially when used brand new "out of the box". Breath actuated integrated vortex spacer (Synchro-Breathe) is a compact palm sized antistatic device with a vortex chamber which is designed to be more patient friendly and free from the effects of electrostatic charge. The systemic bioavailability from the lung of inhaled fluticasone and salmeterol is dependent on respirable dose delivery, and hence the performance of inhaler devices can be quantified by measuring the degree of adrenal suppression and fall in serum potassium(K) as surrogates for delivered lung dose. This study attempts to compares the systemic bioavailability from the lung in real life conditions for Fluticasone/Salmeterol combination (measured in terms of relative adrenal suppression and fall in serum K) via the breath actuated Synchro-Breathe device, pMDI( Seretide Evohaler), and Aerochamber Plus \& Volumatic spacer used brand new "out of the box" in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy Volunteers
2. Male or female 18-65
3. Informed Consent
4. Ability to comply with the requirements of the protocol

Exclusion Criteria:

1. No respiratory disease
2. Smokers
3. Recent respiratory tract infection (2 months).
4. Any other clinically significant medical condition such as unstable angina, acute myocardial infarction in the preceding 3 months, recent TIA/ CVA,that may endanger the health or safety of the participant, or jeopardise the protocol.
5. Any significant abnormal laboratory result as deemed by the investigators
6. Pregnancy, planned pregnancy or lactation
7. Known or suspected contra-indication to any of the IMP's
8. Concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial
Telaprevir With Peginterferon Alfa & Ribavirin in Ex-People Who INject Drugs Infected by Genotype 1 Chronic Hepatitis C

The purpose of this study is to collect information on the efficacy, safety and tolerability of telaprevir (in combination with other medications), in patients who have a history of intravenous drug use with genotype 1 chronic hepatitis C, under substitution therapy (eg., methadone, buprenorphine) and/or followed in addiction centres.

This is a multicenter, non-interventional, observational, prospective study to evaluate the efficacy, safety, and adherence to telaprevir in ex-People Who Inject Drugs (ex-PWIDs) infected with genotype 1 chronic hepatitis C and any fibrosis stage including compensated cirrhosis, who are receiving substitution therapy (eg, methadone, buprenorphine) and/or are being followed in an addiction center. Patients may be treatment naïve or relapsers. Participating physicians are to offer enrollment in this study to all eligible patients at their site in who they plan to initiate triple therapy with telaprevir, pegylated interferon alfa (PegIFN alfa), and ribavirin (RBV). A target of 115 patients will participate in this study. The duration of each patient's participation in this study will be up to approximately 60 weeks. After obtaining the signed participation agreement or ICF, selection criteria will be reviewed to verify the patient's eligibility. Data will be recorded in the electronic case report form (CRF) at 6 time points for each patient which correspond to routine care visits: inclusion, and at the patient's routine care visit closest to Week 4, 12, and 24, end of treatment, and end-of-follow-up (e.g., approximately 12 weeks after end-of-treatment). No additional blood, urine, or other biological samples will be required, and no additional investigations, beyond the routine clinical management of the patient, will be performed.

Eligibility Criteria:
Inclusion Criteria:

Have HCV genotype 1, a quantifiable serum HCV RNA, recent (within 18 months of baseline) documentation of the degree of liver fibrosis (Metavir F0-F4; Ishak 0-6) assessed by liver biopsy or non-invasive test (eg, fibrotest, fibroscan); Physician decision to start triple therapy with telaprevir and PegIFN alfa/RBV; Have never been treated with antiviral treatment (naïve) or who have relapsed after IFN or PegIFN plus RBV (relapsers); History of injecting drugs and are currently under stable substitution therapy (eg, methadone, buprenorphine) and/or followed in an addiction center.

Exclusion Criteria:

Infected or coinfected with HCV of a genotype other than genotype 1; Previous or current treatment with a DAA therapy; Have any contraindication specified in the SmPC for telaprevir, PegIFN alfa, or RBV; Have a history or other evidence of decompensated liver disease, or have coinfection with active hepatitis B or HIV; Currently participating in another investigational study or clinical study.