cyrilzakka/clinical-trials huggingface dataset:
Quality of Life in Presbyopes Using Single-vision Lens and Progressive Lens Correction

The goal of this clinical trial is to compare the quality of life (QOL) of presbyopes wearing progressive addition lenses (PALs) with that of those wearing single-vision spectacles (SVSs) for near correction. The main questions it aims to answer is:

What is the difference in QOL between presbyopes who use SVSs and those who use PALs ? Eligible participants will be randomly assigned in a 1:1 ratio to either the PALs group or the SVSs group.Participants in the progressive lenses intervention group will receive 1-month progressive lens correction in daily life. And participants in single-vision lenses intervention group will use near-vision spectacles during near work and use their original habitual distant glasses for distance tasks for 1 month.

The study will compare the QOL scores measured by a 12-item Near Vision-Related Quality of Life questionnaire between the two groups. Additionally, the study will compare the scores measured by the Refractive Status and Vision Profile questionnaire and Visual Analogue Scale questionnaire between the two groups as well as assess the change in the above three questionnaires scores at 1 month following enrollment. And visual acuity of subjects will also be assessed at baseline and at the 1-month follow-up.


Eligibility Criteria:
Inclusion Criteria:

1. Age 40-70 years;
2. A distant correction of ≤2D for hyperopia, or \>-2 D for myopia, or \< 2D for astigmatism in both eyes;
3. Anisometropia of less than 1.50 D;
4. Distance best-corrected visual acuity (BCVA) of at least 0.5 LogMAR, and near VA \< N8 (20/50) at 40 cm with habitually worn distance refractive correction, with improvement of near vision by at least one line on a near LogMAR E chart with the use of a plus lens;
5. Have not undergone any near correction in the past six months;
6. Able to answer a questionnaire;
7. Giving written consent to participate in the study.

Exclusion Criteria:

1. Ocular abnormalities leading to visual impairment including severe cataract, glaucoma, strabismus, and ocular fundus diseases;
2. Severe physiological and psychological diseases affecting follow-up;
3. History of cataract surgery, phakic intraocular lens surgery, corneal surgery, or any intraocular surgery affecting the refractive status of the eye;
4. Have used pilocarpine in the past six months.
Virus Interactions in the Respiratory Tract; a Cohort Study With Children

Rationale: Prevention of virus induced acute respiratory infection (ARI) is a public health priority. As different respiratory virus infections can interact with each other, occurrence of one virus may influence occurrence of other virus infections. Such interactions can have implications for the effects of vaccination on non-target diseases. In this project, we will quantify such interactions between respiratory viruses by longitudinally studying a cohort of young children.

Objective: To quantify the strength and direction of interactions between important respiratory virus infections in young children.

Study design: This is a prospective observational cohort study.

Study population: Children between 6 weeks and 4 years of age residing in the Utrecht area of the Netherlands.

Main study parameters/endpoints: Frequency, timing and sequences of occurrence of respiratory virus infections will be studied for each participant using weekly collected nasal specimens during 16 weeks follow-up. Detection will be based on PCR testing for a panel of common respiratory viruses. From these data, estimation of virus interaction parameters will be based on self-controlled-case series analysis.

Nature and extend of the burden and risks associated with participation, benefit and group relatedness: This study is observational in nature. There will be no direct benefit to research participants. The study includes biological sampling. The results of the tests done on these samples may not contribute to improving the participant's health. Minimal inconvenience and discomfort to the participant may arise from study visits and biological sampling.


Eligibility Criteria:
Inclusion Criteria:

* Age between 6 weeks and 4 years AND
* 1) have older siblings or 2) attend daycare. AND
* Live within 30 minutes drive from UMCU (by car), have access to a fever thermometer and a freezer were biological samples can be temporarily stored

Exclusion Criteria:

* recurrent respiratory tract infections and are treated with antibiotic prophylaxis OR
* known immunodeficiency OR
* chronic lung disease that increases susceptibility to infection (e.g. cystic fibrosis) OR
* congenital anomalies of the airways
* Parents/guardians have insufficient comprehension of Dutch language (all study communication and questionnaires are in Dutch language)
Reliability and Validity of the Turkish Version of Caregiver Functional Use Survey (CFUS)

Increasing the number of Turkish version of the questionnaire evaluating hand use, adding the scales that evaluate the selective movements of the upper limb to the evaluations will increase the variety of evaluation methods.

The purpose of this study is to evaluate the validity and reliability of the Turkish version of the Caregiver Functional Use Survey (CFUS)

CFUS was designed to assess caregivers' perceptions of how much and how well their child used the involved upper extremity.

Children's upper extremity functions will be assessed with a Jebsen Taylor Hand Function Test. Their family will be asked to fill the CFUS.

Compare the relationship between Jebsen-Taylor Hand Function Test and Turkish Version CFUS. Investigate the internal consistency of Turkish-version of CFUS by using Cronbach's alpha coefficient.

Eligibility Criteria:
Inclusion Criteria:

* Ages between 3-15 years
* Diagnosed as Cerebral Palsy (Hemiplegia)
* Literate in Turkish language and can complete the questionnaire by primer caregiver

Exclusion Criteria:

* Cannot understand the questionnaire by themselves.
* Participants had a botulinum toxin injection within the last 6 months
* Any surgical correction within the last year
Molecular Biology in the Identification of Pathogens at Reimplantation in the Two-Stage Treatment of Periprosthetic Infections

The goal of this observational study is to measure the diagnostic accuracy of the Multiplex PCR technique in identifying pathogens during the diagnostic stage of resolving pre-implantation infection, in the context of treatment according to two-stage protocol for PJIs. This evaluation will be conducted by comparing the results obtained by Multiplex PCR with those derived from standard culture examination.

The data that will be collected are:

1. Pre-implantation data: timing of infection, bacterial population involved, type of surgery (primary or revision implantation). Baseline characteristics of patients, such as gender, age, history of previous interventions (including date, number and type of interventions), comorbidities, ASA score, and lifestyle habits (such as smoking and alcohol) will also be recorded. Local problems of the operated limb and investigations performed, including instrumental and laboratory tests, will be documented.
2. Data on explant surgery and postoperative course: details of whether or not spacer cement was used according to the two-stage protocol, the type of spacer cement used, the occurrence of intraoperative complications and the characteristics and duration of postoperative antibiotic therapy will be recorded. Results of molecular investigations will be documented, both pre-operative on ultrasound aspirate, intraoperative and 15 days after discontinuation of antibiotic therapy. Results of histological and culture examinations of the preoperative and intraoperative aspirate, postoperative complications will be included.
3. Data related to reimplantation: timing of reimplantation, result of molecular, culture, and histological examinations on intraoperative specimens, post-reimplantation antibiotic therapy, intraoperative and postoperative complications, clinical status at follow-up (recurrence/persistence of infection), and duration of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of periprosthetic infection of hip, knee, shoulder on primary or already revised implant.
* treatment of infection with two-stage protocol.
* Obtaining informed consent
* Age ≥18 years

Exclusion Criteria:

* Isolates obtained during explantation not included in MULTIPLEX PCR panel
Fibrosis, Inflammation and Brain Health in Atrial Fibrillation.

Protocol synopsis Sponsor: Oslo University Hospital Title: Fibrosis, inflammation and cerebral infarction in patients with atrial fibrillation Study Design: The study is an observational prospective study of atrial fibrillation patients undergoing direct-current cardioversion.

Primary Objective: To assess the prevalence and causes of new silent cerebral ischemic lesions after programmed direct-current cardioversion using diffusion-weighted sequences in brain MRI (DWMRI).

Secondary Objectives:

To study the impact of inflammation measured by biomarkers and cardiac 18F-FDG-PET on the risk for new silent cerebral ischemic lesions after direct-current cardioversion for AF.

To assess the impact of fibrosis measured by biomarkers on the risk for new silent cerebral ischemic lesions after direct-current cardioversion for AF.

To assess cognitive and cerebral structural and metabolic changes after direct-current cardioversion for AF using cognitive assessments and cerebral and cardiac 18F-FDG-PET before and 12 months after treatment.

Number of Subjects: 50

Study Centers: Østfold Hospital Trust

Duration of Study Participation:

* Enrollment: 18 months
* Follow-up period: 12 months
* Total Study Duration: 30 months

Primary Endpoints:

• Number of new small cerebral infarcts detected with DWMRI two weeks after direct current cardioversion.

Secondary Endpoints:

* Rate of AF recurrence within 1 year after direct current cardioversion
* Change in levels of inflammation biomarkersfrom baseline to 12 months follow-up
* Change in levels of fibrosis biomarkers from baseline to 12 months follow-up
* Cognitive function at 12 months follow-up
* Changes in uptake pattern on cerebral 18F-FDG-PET from baseline to 12 months follow-up
* Changes in uptake pattern on cardiac 18F-FDG-PET from baseline to 12 months follow-up
* Brain volume at 12 months follow-up
* White matter volume 12 months follow-up
* Grey matter volume 12 months follow-up
* Cortical volume 12 months follow-up
* RSI-derived diffusion parameters 12 months follow-up: fast apparent diffusion coefficient, extracellular water fraction, fractional anisotropy; free water fraction; intracranial volume; NAWM: normal appearing white matter; neurite density; RSI: restriction spectrum imaging; sADC: slow apparent diffusion coefficient;restricted fractional anisotropy; white matter lesions.


Eligibility Criteria:
1. Known atrial fibrillation
2. Age \<80 years
3. CHA2DS2-VASc ≤ 4
4. Planned direct-current cardioversion

Exclusion criteria:

1. CHA2DS2-VASc \>4
2. Life expectancy less than 1 year
3. Patient otherwise not eligible for the study or adherent for follow-up (eg nonresident) or has concurrent disease affecting outcome (e.g. multiple sclerosis, cancer)
Open Label Trial on the Safety and Efficacy of Sym001 in the Treatment of Immune Thrombocytopenic Purpura (ITP)

This trial is designed as a multi-centre, single-dose, exploratory dose-finding, open label trial evaluating the safety and efficacy of Sym001 in 4-9 consecutive cohorts. Subjects will receive a single IV dose of Sym001.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed presence of thrombocytopenia with platelet count \< 30,000/mm3 at the pre-dose visit.
* History of isolated ITP
* RhD-positive serology.
* Previous treatment and response to first line therapy for ITP

Exclusion Criteria:

* Known clinical picture suggestive of other causes of thrombocytopenia, especially systematic lupus erythematosus,antiphospholipid syndrome, Evans syndrome, immunodeficiency states, lymphoproliferative disorders, liver disease,ingestion of drugs such as quinidine/quinine, heparin and sulfonamides and hereditary thrombocytopenia confirmed by relevant laboratory findings.
* Suspected infection with HIV, Hepatitis C, H. pylori.
* Clinical splenomegaly
* History of abnormal bone marrow examination.
* Ongoing haemorrhage corresponding to a grade 3 or 4 on the WHO bleeding scale.
* Underlying haemolytic condition
* History of splenectomy.
* Subject is pregnant, breast feeding or intends to become pregnant.
Derivation of a Clinical Decision Rule for Emergency Department Head CT Scanning in Seniors Who Have Fallen

Falls are the leading cause of traumatic death in the elderly with head injury causing half of these deaths. Each year, one in three adults over the age of 65 (seniors) fall, and half of these seniors seek treatment at a hospital emergency department (ED). There is a major evidence gap in the study of brain injury diagnosis in seniors, which is problematic for emergency physicians since the number of fall-associated head injuries is rising. ED diagnostic tools for risk stratification of these patients do not exist. The investigators will derive a novel ED clinical decision rule for detecting traumatic intracranial bleeding which will standardize the approach to head CT scans. Once validated, the investigators will optimize patient care by ensuring that intracranial bleeding is identified early. By reducing the use of head CT, this decision rule will lead to health care savings and streamlined, patient-centered ED care.

This study is designed to develop a unique clinical decision rule for ED physicians evaluating senior patients who have fallen. Clinical decision rules are a common method for standardizing diagnostic decision-making and minimizing misdiagnosis in the ED. Each patient will be assessed at their index ED visit by an emergency physician who will record history and examination findings. The primary outcome will be clinically important intracranial bleeding diagnosed with 42 days. Patients who return to the ED within 42 days with new confusion, headache, loss of balance, repeat falls, change in behaviour, reduced Glasgow Coma Scale score or other neurological symptoms will also undergo head CT. All intracranial bleeding events will be adjudicated independently.

Eligibility Criteria:
Inclusion Criteria:

* 65+ years old
* Fall within 48 hours of emergency department visit (regardless of presenting complaint)

Exclusion Criteria:

* Repeat event/visit (already enrolled in the study)
* Transferred from another hospital
* Lives outside of hospital catchment area
* Major trauma (e.g. fall from steps, fall from height, motor vehicle accident, struck by a vehicle, recreational accident)
* Left emergency department prior to completion of assessment (left against medical advice)
Thromboembolic Complications Related to Asparaginase in Children With Acute Lymphoblastic Leukemia (ALL) Treated According to NOPHO ALL 2008

The study will examine the prevalence of venous thromboembolism in children with acute lymphoblastic leukaemia treated in accordance with NOPHO ALL-2008. The investigators will prospectively study clinical symptomatic thromboses, asymptomatic central line-associated thromboses, and infections.


Eligibility Criteria:
Inclusion Criteria:

* Acute lymphoblastic leukaemia,
* Age 1 year to 16 years old,
* Central line,
* Protocol NOPHO ALL 2008.

Exclusion Criteria:

* Refusal of participation,
* Treated according to protocol other than NOPHO ALL 2008.
Climate Friendly and Ecological Food on Microbiota

The aim of this study is to investigate changes in nutrient intake, the human gut microbiota and pesticide excretion in urine when shifting from conventional food habits to sustainable food habits.


Eligibility Criteria:
Inclusion Criteria:

* Living in Västerås
* Carnivores
* Healthy

Exclusion Criteria:

* Vegans
The Effects of Natural Extracts Supplementation on NASH Patients

The global wave of obesity has affected dramatically the incidence of non-alcoholic fatty liver disease (NAFLD) making it the leading cause of liver disease in the western world. NAFLD is considered the hepatic manifestation of metabolic syndrome and is strongly associated with type II diabetes, sleep apnea and cardiovascular disease. Although cardiovascular disease is the leading cause of death in patients with NAFLD, a subset of patients who meet the histological criteria for steatohepatitis have the highest risk for liver-related morbidity and mortality.

Reviewing literature, it appears that several pathophysiologic mechanisms related to metabolism, inflammation and fibrosis are deregulated in NAFLD. Choline, Vitamin C, Vitamin E and Ampelopsis Grossedentata natural extracts exhibit high antioxidant activity. In contrast to Vitamin E, which has been extensively studied and has a role as a drug of choice in non-diabetic patients with NAFLD, epidemiological or clinical data for the use of Choline, Vitamin C, Ampelopsis Grossedentata natural extracts or their combination in NAFLD are limited.

The study will be randomized, placebo-controlled and double-blinded in order to avoid a number of systemic errors, such as selection bias and the placebo effect. Patients will be randomly assigned to one of the two categories: (A) a placebo group (B) a Choline - Vitamin C, E and Ampelopsis Grossedentata natural extracts tablets supplementation group (two tablets twice per day). The duration of the intervention will be 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Alanine aminotransferase (ALT) \>1.5 times the greater normal value with or without elevated γ-glutamyl transpeptidase (γGT)
* Hepatic steatosis-indicating findings on ultrasound and / or liver biopsy
* BMI 20-40 Kg/m2

Exclusion Criteria:

* Alcohol consumption \> 210 or \> 140 grams per week for men or women, respectively
* Use of a potentially hepatotoxic drug
* Detection of hepatitis B virus (HBsAg) surface antigen or Hepatitis C virus antibodies (anti-HCV) or HIV antibodies
* The coexistence of α systemic disease with potentially hepatic involvement
Group Therapy Compared With Educational Materials in Patients With Prostate Cancer

RATIONALE: Developing coping strategies may help improve the quality of life of patients with prostate cancer.

PURPOSE: This randomized clinical trial is comparing the effect of group therapy with written educational materials on the quality of life of men with stage I or stage II prostate cancer.

OBJECTIVES:

* Determine the feasibility of providing group support, and evaluate the effect of supportive-expressive group therapy vs. written educational material on the psychological health and quality of life of men with stage I/II prostate cancer.

OUTLINE: Patients are stratified by prior hormonal therapy.

Patients continue standard oncologic treatment concurrently with supportive-expressive group therapy.

Supportive-expressive group therapy consists of twelve 90-minute weekly meetings with 8-12 members and 2 cotherapists and is based on the following themes: building bonds, expressing emotions, detoxifying dying, taking time to prioritize and set realistic goals, fortifying families, and dealing with doctors. Each session commences with a brief stress reduction exercise and ends with a brief cognitive restructuring imagery exercise. The main portion of the meeting emphasizes providing an environment in which patients can share their concerns, feelings, and thoughts openly and honestly. The role of the cotherapist is to facilitate expression of patients' concerns, offer empathy, and continue to encourage patients to express their feelings and thoughts.

Quality-of-life questionnaires are filled out at 3 and 6 months and then every 6 months for a total of 2 years.

PROJECTED ACCRUAL: Approximately 480 patients (including an estimated 53 minority patients) will be entered in this multicenter study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Biopsy-proven prostate cancer diagnosed within 1 year prior to entry

  * Clinical stage I/II (T1b-c or T2, N0 or Nx, M0) disease

    * Pathologic local upstaging (e.g., to T3) allowed

      * No Nx disease if pathologic or partial pathologic (e.g., lymph node biopsy or dissection) staging performed
* No major psychiatric illness requiring hospitalization or medication other than depression or anxiety for less than 1 year
* No second malignancy within 10 years except nonmelanomatous skin cancer
* Clinical follow-up by a urologist, medical oncologist, or radiation therapist required at least semi-annually

PATIENT CHARACTERISTICS:

Age

* Not specified

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* See Disease Characteristics

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified
Chest Physiotherapy Effects on Intracranial Pressure

The investigators will study the effects of a chest physiotherapy technique (rapid thoracic compression) on the intracranial pressure of individuals with acute cerebral injury and with need of intubated mechanical ventilation

Patients with acute brain injury often require invasive mechanical ventilation connection, increasing the risk of developing complications such as respiratory secretions retention. Thethoracic compression is a manual chest physiotherapy technique that can improve clearance of secretions in these patients. Although today the scientific evidence is contradictory, the manual abdomino-thoracic compression may be associated with increased intracranial pressure in patients with acute brain injury.

Objectives: The aim of this work to study the effects of manual thoracic compression technique in intracranial pressure in mechanically ventilated patients. Furthermore, the effects of the technique in different volumes and flows recorded by the ventilator and the relationship between the pressure applied in the intervention group and the different variables will also be studied.

Methodology: It will be a randomized clinical trial, single-blind in the application of the techniques. Patients with acute brain injury in invasive mechanical ventilation will be included, randomized into two groups. In the control group, a technique of passive inferior limbs mobilization will be applied and in the intervention group it will be performed the manual thoracic compression technique. The data of the primary variable, intracranial pressure will be collected with a monitoring system and continuous recording (Integra Camino).

A descriptive analysis of the values collected from the variables in the study will be performed, studying the measures of central tendency. In the presence of normal distribution will be presented mean and standard deviation, and median and interquartile range in case of non-observation of normal distribution. The normality of the samples will be verified with the Kolmogorov-Smirnov test. The verification of the hypothesis in study will be assessed using the Student T test for independent samples in case of sample normality and by the Wilcoxon test otherwise. A multiple linear regression analysis will be performed: considering as a dependent variable the differences in intracranial pressure, difference or volume / minute gain and expiratory flow and between the covariates, the type of technique, the pressure applied in the technique under study, the type of brain injury, age, sex, etc.

Eligibility Criteria:
Inclusion Criteria:

* intubated patients for 48 hours in vc, pc, vcrp
* hemodynamically stable (MAP\>60mmHg)
* respiratory stability (PEEP\<15cmH2O and FiO2\<60%)
* ICP stable (0\<icp\<20mmHg)
* RASS of 5
* informed consent signed

Exclusion Criteria:

* thoracic fractures
* abdominal injuries that limits local pressure
* systemic or local changes that undergoes with abdominal volume increase
* inferior limbs fractures that contraindicates passive mobilization techniques