cyrilzakka/clinical-trials huggingface dataset:
Visual Outcomes of a Segmental Refractive Multifocal Intraocular Lens

To evaluate visual outcomes of a segmental refractive multifocal intraocular lens (IOL) after cataract surgery.

Purpose: This prospective, nonrandomized noncomparative case series investigates the visual performance after bilateral implantation of a segmental refractive multifocal intraocular lenses (IOL) after cataract surgery and was performed at the department of Ophthalmology, Goethe University, Frankfurt, Germany.

Methods: Fifty eyes (25 patients) were included. Inclusion criteria were bilateral cataract, age \> 45 years, corneal astigmatism ≤ 0.75 D postoperatively, pupil size 3 to 6 mm (mesopic), and center shift \< 1 mm (Pentacam). Exclusion criteria were previous ocular surgeries, amblyopia or potential postoperative distance-corrected visual acuity (DCVA) \< 0.3 logMAR,

Intervention or Observation: Uncorrected (UCVA) and DCVA in 4 m, 80 cm, 40 cm; contrast sensitivity (CS) under photopic and mesopic conditions; reading skills (Radner Reading Charts); defocus curve, questionnaire on optical quality (OQ) and spectacle independence were assessed after 3 months.

Main Outcome Measures: At 3 months postoperatively, UCVA and DCVA in 4 m, 80 cm, 40 cm (logMAR); defocus curves; CS; reading skills; and OQ questionnaire results.

Eligibility Criteria:
Inclusion Criteria:

* bilateral cataract
* age \> 45 years
* corneal astigmatism ≤ 0.75 D postoperatively
* pupil size 3 to 6 mm (mesopic)
* center shift \< 1 mm

Exclusion Criteria:

* previous ocular surgeries
* amblyopia
* potential postoperative distance-corrected visual acuity (DCVA) \< 0.3 logMAR
Disaster Preparedness of Older People

Disasters; It is an important public health problem of uncertain time, causing loss of life and property, having severe economic consequences, and causing serious health problems in the long term. In dealing with disasters, it is expected that measures to reduce the damage and losses caused by the hazards that the disaster may cause are taken during the disaster preparedness phase. For this reason, the individuals in the society should be educated before the disaster and their preparedness for the disaster should be ensured. While it is possible for young age groups to access information, participate in public education and self-learning, they need support for their preparedness for disasters because there is no disaster education program specific to older individuals. This project was designed as a single-blind (participant) randomized controlled study in order to examine the effect of the Disaster Preparedness Education Program (SIMAH) based on the Health Belief Model of older people in the society on their preparedness to disasters according to the active control group to which the public education materials prepared by the Disaster and Emergency Management Presidency (AFAD) will be given. The research was planned to be carried out in a total of six clusters in Antalya province Muratpaşa district and Konyaaltı district between October and December 2023 in older people houses, retirement cafes and district parks where older people are concentrated. The sample size was calculated as 66 older individuals (intervention: 33, control: 33). The SIMAH Program, which includes interactive group training for three months, public education materials prepared by AFAD, and reminder phone messages, will be applied to the initiative group. Public education materials prepared by AFAD will be given to the active control group in the same period. Outcomes will be measured with the Disaster Readiness Scale, the General Disaster Preparedness Belief Scale, and the Individual Disaster Preparedness Evaluation Form, before the intervention, after the training program, and three months later.


Eligibility Criteria:
Inclusion Criteria:

* Those who come to the places where the research will be carried out,
* Those aged 60 and over,
* Those who can speak and understand Turkish,
* Those who get 9 points or more from the Mini-Mental State Examination,
* Those who have and can use a smart phone,
* Those who have voluntarily agreed to participate in the study,
* One elderly person from the same household will be included in this study.

Exclusion Criteria:

-Those who have previously received disaster preparedness training will not be included in the study.
Exercise in Men Receiving Radiation Therapy for Prostate Cancer.

Androgen Deprivation Therapy is a commonly used treatment for men with Prostate Cancer. Unfortunately this can lead to functional decline, fatigue, increased body fatness, loss of lean body tissue and impaired QOL. Previous research has demonstrated the exercise can may reduce fatigue and improve QOL in men on ADT. This study will evaluate whether aerobic versus resistance exercise over a 24 week period of training will reduce morbidity and improve QOL in men receiving radiation plus or minus ADT with curative intent

A total of 220 men with a diagnosis of prostate cancer, scheduled to receive radiation will be recruited. The study is a parallel 3-group design with groups stratified for intended duration of ADT ( greater or less than 12 weeks) and random assignment to aerobic, resistance or Wait List control groups. The dependent variable of interest will fatigue measured at 24 weeks by the 13 item FACT-Fatigue. Dependent variables of secondary interest will be toxicity of radiation, body composition, muscular fitness, cardio-respiratory fitness, metabolic fitness, and prostate specific QOL. All exercise sessions will be performed 3 times per week at the Ottawa Hospital regional Cancer Center

Eligibility Criteria:
Inclusion Criteria:

* Prostate Cancer
* Radiation Therapy with curative Intent
* ADT

Exclusion Criteria:

* Contraindication to exercise
* Uncontrolled hypertension
* Uncontrolled Cardiac Disease
* Uncontrolled psychotic condition
* Unable to obtain informed consent
Kalogon Pilot Fatigue and Comfort Study

The goal of this experimental study is to compare 2 different seat cushions in B52 cockpit seats to see if they affect pilot fatigue and comfort. The main questions it aims to answer are:

1. Does the Kalogon AF Prototype seat cushion improve pilot comfort compared to the standard seat cushion?
2. Does the Kalogon AF Prototype seat cushion reduce pilot fatigue compared to the standard cushion?

Participants will spend 8 hours in a simulated cockpit playing a flight simulator. They will fill out multiple questionnaires and take 2 attention/reaction time tests throughout the 8-hours.

Participants will be screened for eligibility and if they qualify will be asked to provide informed consent and sign a photo release. Participants will be asked to avoid caffeine consumption on the day of testing, wear comfortable clothing with no back pockets on the pants/shorts, and bring food and water for them to consume during testing.

Once informed consent is given, they will be measured and weighed. They will then be given a flight suit to wear. Once they are in the flight suit, the first 5-minute Psychomotor Vigilance Task test (PVT) will be administered. Once completed, the participant will be strapped into the pilot seat.

Once the participant is properly secured to the pilot seat, the 8-hour timer will be started and the first Subjective Fatigue Survey will be administered. Once the questionnaire is completed they will begin playing the flight simulator. Participants will be encouraged to minimize bathroom breaks and will be given specific times to eat. At the 4-hour mark, the second Subjective Fatigue Survey will be administered. At the end of the 8 hours, a second PVT will be administered, followed by the final Subjective Fatigue Survey.

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* 18 to 35 years old
* Ambulatory
* Able to sit for up to 12 hours with minimal breaks
* Able to follow instructions in English

Exclusion Criteria:

* Weight \<91 lbs or \> 250 lbs
* Pregnant
* Travel across time zones in the last 7 days
* History of:
* Chronic pain
* Asthma or other bronchospasm diagnoses
* Abnormalities of the heart valves, major vessels, heart rate or rhythm, any condition leading to poor circulation, increased risk of blood clots
* Chronic disease of abdominal organs including hepatitis and inflammatory bowel disease
* Un-united fractures, instability of a major joint, retained orthopedic fixation devices, severe scoliosis, or disorder of the skeletal muscles
* Psoriasis
* Psychosis, schizophrenia, or other severe mental health disorder
* Seizure disorders
* Sleeping disorders
* Taking any of the following medications:
* Opiates
* Muscle relaxants
* Anticholinergics
* Sedating antihistamines
* Anti-psychotics
ASIA-Mesh: a Pilot Study for Diagnostics and Treatment on ASIA Syndrome Caused by Polypropylene Mesh Implantation

In the present pilot study, a possible relation between the implantation of PP mesh for inguinal hernia, vaginal prolapse and SUI repair and subsequent systemic auto-immune complaints is investigated by testing immunologic and allergic responses in fifty patients with suspected ASIA syndrome. Additional value of MAT is investigated and effectiveness of (partial) PP mesh removal for these complaints is assessed. If so, a profound insight in diagnostics and treatment for systematic complaints will be attained that may provide opportunities for future diagnostics.

Worldwide there is a lot of commotion about the effects and complications of various implants. In analogy to patients with silicone breast implants, some patients report various systemic complaints following inguinal polypropylene (PP) mesh implantation, suggesting 'Autoinflammatory/Autoimmunity Syndrome Induced by Adjuvants' (ASIA; Shoenfeld's syndrome) or some other suspected systemic auto-immune/inflammatory response. Although an evidence-based and causal relationship is lacking, patients report serious complaints. Therefore, the investigators recently started seeing these patients at the outpatient clinic and developed a diagnostic workup, including an elaborate anamnesis, conventional immunologic analyses and mesh allergy testing (MAT). Further, in case the implant is removed as part of the treatment due to a persistent wish of the patient, the PP explant will be histologically examined to find additional cues for an auto-immune/inflammatory response (and thus ASIA). So far, evidence on the optimal diagnostic workup for patients with suspected ASIA syndrome is lacking completely.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years of age and written informed consent obtained;
* Suspected ASIA syndrome after elective hernia, pelvic organ prolapse (POP) surgery, or stress urinary incontinence (SUI) repair, defined as three major ASIA criteria (Table 1), of which the exposure to an external stimulus (PP mesh) is one;
* ASIA complaints evolved after the implantation of PP mesh and were not present before the surgical repair.

Exclusion Criteria:

* Known auto-immune disorders;
* Known malignancies;
* (Low grade) infections or other inflammatory diseases at time of surgery;
* Cognitively impaired individuals.
Post-Market Study of Comprehensive Reverse Augmented Glenoid and Mini Humeral Tray in Total Shoulder Arthroplasty

This study is a multicenter, prospective, non-randomized, non-controlled, dual cohort post market surveillance study. The primary objective of this study is to confirm the safety and performance of the Comprehensive Reverse Shoulder System when used with the Comprehensive Porous Augmented Glenoid Baseplate and/or Comprehensive Mini Humeral Tray in primary and revision reverse shoulder arthroplasty.

The Comprehensive Reverse Porous Augmented Glenoid Baseplate and Comprehensive Mini Humeral Tray belong to the Comprehensive Reverse Shoulder Arthroplasty System. They were developed to provide patients with grossly deficient rotator cuffs with another surgical option. The aim of the Comprehensive Reverse Shoulder System is to increase shoulder function while reducing pain.

A maximum of 7 sites will contribute to this study. Enrollment of 7 sites on a global scale will allow for assessment of device consistency across different regions. Enrollment per site will not exceed 45 shoulders. 146 implants will be included in this study with competitive enrollment. All potential study subjects will be required to participate in the Informed Consent process.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be 18 years of age or older.
* Patient must be anatomically and structurally suited to receive the implants and possess a functional deltoid.
* Patient must have a grossly deficient rotator cuff with severe arthropathy and/or a previously failed shoulder joint replacement with a grossly deficient rotator cuff.
* Patient must be able and willing to complete the protocol required follow-up.
* Patient must be able and willing to sign the Institutional Review Board/Ethics Committee approved informed consent.

Exclusion Criteria:

* Patient is a prisoner.
* Patient is a current alcohol or drug abuser.
* Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
* Patient presents with osteoporosis.
* Patient has a metabolic disorder that may impair bone formation.
* Patient has osteomalacia.
* Patient has distant foci of infections which may spread to the implant site.
* Patient has rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.
G-PUR® for Reduced Dietary Fumonisin Bioavailability

This prospective, placebo-controlled, randomized, monocentric, double-blind, crossover study in healthy volunteers aims to assess the effect of a single dose of 2 g G-PUR® on bioavailability of dietary fumonisin and to evaluate safety and tolerability.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male and female subjects
2. Age 18-55 years
3. BMI 17-27
4. Subjects are in good clinical and mental health as established by medical history and physical examination
5. Subject understands the scope of the study and agrees to strictly adhere to the study related diet plan
6. Written informed consent

Exclusion Criteria:

1. Pregnancy or breastfeeding.
2. Lack of willingness or capacity to co-operate appropriately
3. Regular use of medications in the previous 2 months (except oral contraception)
4. History of malignancies within the past two years or on current anticancer treatment
5. History of gastrointestinal pathology such as clinically relevant gastritis, gastric ulcers, inflammatory bowel disease, chronic constipation
6. History of diarrhoea within the past 14 days of screening
7. History of gastrointestinal surgery with exception of appendectomy
8. History of any chronic liver disease
9. History of autoimmune disease requiring treatment within the past two months of screening
10. Known symptomatic food allergies
11. Active infection (including HIV and hepatitis B or C), or abnormalities in laboratory testing, vital signs, or physical examination
12. Hypersensitivity to aluminium and/or silicon
13. Chronic renal disease requiring dialysis
14. Alcohol, cigarette or drug abuse
15. Presence of any condition that impacts compliance with the study procedures
16. Use of any investigational or non-registered product (drug or device) within 30 days preceding the first study product administration, or planned use during the study period
17. Employee at the study site, spouse/partner or relative of any study staff (e.g. investigator, sub-investigators, or study nurse) or relationship to the sponsor
Effect of Statin Use on Aldosterone Secretion

The purpose of this research protocol is to determine if the same effects are observed in vivo in humans through a randomized controlled study. Data regarding a novel mechanism of the widely used statin class of medications on the mineralocorticoid pathway would likely have significant clinical implications on the future management of hypertension and other cardiovascular disease given the known pleiotropy of aldosterone action.

In order to provide additional evidence regarding the effect of statin therapy on aldosterone levels, the investigators propose the following randomized, double-blinded, placebo controlled protocol in relatively healthy volunteers. The investigators will evaluate aldosterone and cortisol production in response to an angiotensin II infusion under the following test conditions: 1) placebo, 2) simvastatin therapy (lipophilic statin), and 3) pravastatin therapy (hydrophilic statin). Measurements will be made to assess the effect of both acute (single dose) and chronic (6 and 12 weeks) therapy of the two statin medications.

Eligibility Criteria:
Inclusion Criteria:

* Blood pressure \<140/90 mmHg and \>90/50 mmHg
* Body mass index 19-40 kg/m2
* Normal screening laboratory values for:

  i. Serum sodium, potassium, glucose, liver enzymes ii. GFR (\>60 mL/min/1.73m2) iii. A1c iv. TSH
* Normal ECG
* Negative urine HCG at screening for women who are able to become pregnant.

Exclusion Criteria:

* Any prior use of statin therapy
* History of coronary disease, diabetes, hypertension, stroke, kidney disease, thyroid disease, psychiatric illness, malignancy, preeclampsia, or illness requiring overnight hospitalization in the past 6 months
* Triglycerides \> 500, LDL \> 200
* Any prescription medication or herbal medication including oral contraceptive, excluding thyroid medications
* Unstable thyroid disease (determined by abnormal TSH)
* Pregnancy or current breastfeeding
* Alcohol intake \>12 oz per week
* Tobacco or recreational drug use
Activity and Life-role Targeted Pain Rehabilitation in Primary Health Care

The primary goal of the Swedish national rehabilitation plan on pain is to reduce disability and facilitate return-to-work. However, there is a lack of treatment strategies that effectively target and affect return-to-work and reduce sickness absence, and that in addition are sufficiently easy and feasible to administer in primary care. A new activity and life-role targeting rehabilitation program (ALAR) has been developed to reduce psychosocial barriers to rehabilitation progress, promote re-integration into life-role activities and facilitate return-to-work. The program will be implemented and provided as one of the pain treatment modalities available through multi-professional teams in primary care in one Swedish county. This study aims to evaluate the effect of an activity and life-role targeting pain rehabilitation program on the outcome variables return-to-work and sickness absence.

The primary goal of the Swedish national rehabilitation plan on pain is to reduce disability and facilitate return-to-work. However, there is a lack of treatment strategies that effectively target and affect return-to-work and reduce sickness absence, and that in addition are sufficiently easy and feasible to administer in primary care. A new activity and life-role targeting rehabilitation program (ALAR) has been developed to reduce psychosocial barriers to rehabilitation progress, promote re-integration into life-role activities and facilitate return-to-work. The program will be implemented and provided as one of the pain treatment modalities available through multi-professional teams in primary care in one Swedish county. This study aims to evaluate the effect of an activity and life-role targeting pain rehabilitation program on the outcome variables return-to-work and sickness absence.

Patients seeking care due to disabling back, neck or shoulder pain at seven primary health care units in the County of Dalarna, Sweden, was randomly allocated to ALAR or usual multimodal rehabilitation. Between and within-group differences on return-to-work, sickness absence and disability will be evaluated at 10 weeks, six months, one and two years post-treatment.

The enrollment of patients was ended on preterm in june 2013. Due to changes in the organization in primary health care it was no longer possible to ensure that treatment arms could be delivered as intended. Data collection up to 1-year follow-up is completed. Data from longterm follow-up at 2 years will be completed in june 2015. Data analyses and reporting of results is presently undertaken. The number of enrolled participants is not enough to reach statistical power. Thus, results will need to be interpreted with caution.

Still the results of this pragmatic study will be of importance for the planning of a full scale study to accurately evaluate the effects of ALAR, to be conducted in primary care.

Eligibility Criteria:
Inclusion Criteria:

* Persons seeking primary health care due to back, neck or shoulder pain
* Aged 18 to 60 years
* Being on sick leave or disability compensation
* Able to understand, read and write Swedish
Impact of SARS-CoV-2 (COVID-19) Infection, Treated in Ambulatory Care, on Long-term Quality of Life in a Parisian Military Population

In April 2020, a meta-analysis on the long-term sequelae of respiratory syndromes related to seasonal coronaviruses (SARS and MERS) showed a significant alteration in quality of life, with in particular a decrease in physical and emotional capacities and a deterioration of social life. An improvement of the quality of life is evidenced after 6 months but without reaching the level usually observed in healthy people. The impact of SARS-CoV-2 infection on quality of life can be explained by the persistence of pleomorphic symptoms in the medium to long term. In the military population, the majority of SARS-CoV-2 cases present minor to moderate forms of the disease. Military personnel have living conditions that differ from those of the general population, in particular because of their geographic mobility, which may be responsible for isolation from the family. This isolation can be regular (we speak of "geographical celibacy" when the soldier is posted in a geographical area far from the family unit) and/or occasional, during missions on the national territory or outside. This singularity justifies a study on the impact of SARS-CoV-2 (COVID-19) infection on the quality of life in this specific population.


Eligibility Criteria:
Inclusion Criteria:

* Military personnel
* COVID+: diagnosed with COVID-19 and managed in ambulatory care since March 14th, 2020
* COVID-: not having been infected with SARS-CoV-2

Exclusion Criteria:

* Hospitalized for COVID-19
* Having received a treatment against COVID-19 (other than paracetamol)
12-week Efficacy of Indacaterol

This 12-week study evaluated the efficacy and safety of indacaterol versus placebo.


Eligibility Criteria:
Inclusion criteria:

* Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] Guidelines, 2008) and:

  * Smoking history of at least 10 pack-years
  * Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 80% and ≥ 30% of the predicted normal value
  * Post-bronchodilator FEV1/FVC (forced vital capacity) \< 70%

Exclusion criteria:

* Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization in the 6 weeks prior to screening
* Patients who have had a respiratory tract infection within 6 weeks prior to screening
* Patients with concomitant pulmonary disease
* Patients with a history of asthma
* Patients with diabetes Type I or uncontrolled diabetes Type II
* Any patient with lung cancer or a history of lung cancer
* Patients with a history of certain cardiovascular co-morbid conditions Other protocol-defined inclusion/exclusion criteria applied to the study.