cyrilzakka/clinical-trials huggingface dataset:
Comparison of Two Non- Diffractive Extended Depth of Focus Intraocular Lenses

Intra-individual comparison of the PureSee EDOF IOL with the Acunex Vario EDOF IOL set for emmetropia.

Spectacle-independence is a growing goal in modern cataract surgery. The procedure has evolved from a simple restoration of vision to a presbyopia correction approach. Although bilateral monofocal IOL implantation with the goal of emmetropia results in high patient satisfaction for distance vision, spectacle-dependence for reading and intermediate vision tasks is the usual outcome.

Enhanced Depth of Focus (EDOF) lenses have been on the market for some time to minimize this spectacle-dependency in intermediate tasks (computer work, dashboard, etc.). These IOLs have an extended distance focal range that extends into the intermediate distance, providing high quality vision over a continuous focal range, rather than single foci with blurring in between. The risk to the patient is comparable to that of all other monofocal systems, which generally have high patient satisfaction. The benefit of this study should be continuous sharp binocular vision at distance, intermediate (66 cm) and even near (40 cm). Another expected effect is the reduction of dysphotopic phenomena compared to other EDOF lenses.

The aim of this study is to compare the visual performance of two refractive EDOF lenses, namely the Acunex Vario with the Puresee IOL, in an intraindividual comparative study design. In order to achieve a satisfactory result, we planned to include 40 patients scheduled for cataract surgery in the study.

The examinations will all take place one week before, 1 week and 4-6 months after the operation. These include a visual acuity check at the three distances mentioned, slit lamp examination, pressure control, biometry, pupil width, defocus curve, quality of vision questionnaires, contrast sensitivity, halo\&amp;glare, optical coherence tomography, fundus examination, aberrometry and keratometry.

The main parameter to be examined is the distance-corrected visual acuity for the intermediate distance (66 cm) between the two IOLs at the follow-up examination after 4-6 months.

Eligibility Criteria:
Inclusion Criteria:

* Age-related bilateral cataract
* Age 21 or older
* Visual acuity \&gt; 0.05
* For patients with regular corneal astigmatism greater than or equal to 1.00 dpt toric IOLs will be implanted
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically relevant
* Written informed consent prior to surgery

Exclusion Criteria:

* Active ocular disease (e.g chronic uveitis, diabetic retinopathy, chronic glaucoma not responsive to medication, corneal dystrophies, etc.) precluding good post-operative visual acuity
* Relevant other ophthalmic diseases such as pseudoexfoliation syndrome (PEX)
* Corneal decompensation or corneal endothelial cell insufficiency
* Irregular astigmatism on corneal tomography
* Pronounced dry eye disease
* Previous ocular surgery or trauma
* Persons who are pregnant or nursing (pregnancy test will be taken in women of reproductive age)
Intelligent Electric Bicycle for Health (VELIS) to Optimize the Return to Physical Activity for Oncology Patients

The purpose of this pilot study is to encourage oncology patients to continue effort retraining after their release from rehabilitation and recuperative care facilities with physical activity sessions and therapeutic education using an intelligent electric bicycle (VELIS)

The benefit of physical activity in oncology is now clearly established. Physical activity has its place at all stages of the fight against cancer in primary, secondary and tertiary prevention.

Rehabilitation and recuperative care facilities may be a first step for patients with significant deconditioning, but long-term benefits are essential.

Nevertheless, the post rehabilitation and recuperative care facilities transition period is for these patients a temporary period during which they may loose part of the benefit of effort retraining and physical reconditioning.

The investigators believe that it is necessary to go beyond the "physiological" efficiency to identify and overcome the patient's stereotypes regarding physical activity, to customize and adapt the programs to each patient, and to bring quickly the notion of pleasure and success in the practice of physical activity. Electrically assisted bicycles can reach most of these goals provided that they are adapted.

The objective of this project is to set up and evaluate, thanks to a monocentric pilot study, a process of continuation of exercise retraining through physical activity and therapeutic education sessions for the promotion of physical activity, focusing on the use of electrically assisted bicycles, in continuation of an exercise retraining in rehabilitation and recuperative care facilities.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 and over
* Patient who has followed a post-cancer effort retraining program in a rehabilitation facility at Rocheplane Medical Center
* Patient with the ability to pedal on an outdoor bicycle
* Patient with no restriction to moderate physical activity or bicycling (acute coronary disease of less than 2 years, locomotor problem of the spine or lower limbs incompatible with the practice of cycling)
* Weight less than 125 kg (maximum load for VELIS)
* Patient available for a 4 months follow-up

Exclusion Criteria:

* Patient with a restriction to the practice of moderate physical activity or bicycle (acute coronary disease of less than 2 years, locomotor problem)
* Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponds to all protected persons), pregnant, parturient, nursing mother, person deprived of liberty by judicial or administrative decision, a legal protection measure
Mycotic Antimicrobial Localized Injection for Treatment of Corneal Ulcers

Mycotic Antimicrobial Localized Injection (MALIN) is a randomized, masked, two-arm clinical trial investigating intrastromal voriconazole in the treatment of fungal corneal ulcers. There is currently little evidence to guide the treatment of fungal keratitis beyond topical anti-fungal drops, though intrastromal voriconazole and oral antifungal treatments are used as well. This study will provide evidence to guide the treatment of fungal keratitis in the future. The purpose of this study is to determine differences in microbiological cure for 3-day repeat cultures between different antifungal treatments. For this study, there will be 1:1 randomization to one of these two treatment groups: 1) topical natamycin plus intrastromal voriconazole injection or 2) topical natamycin alone.

The proposed study is a randomized controlled trial to determine whether intrastromal voriconazole improves outcomes in fungal keratitis. Patients presenting to the Aravind Eye Hospitals in Pondicherry, India for treatment of fungal keratitis will be recruited for the proposed study. Approximately 70 patients will be enrolled in the study. Subjects presenting with fungal keratitis will be randomized to receive topical natamycin plus intrastromal voriconazole or to receive topical natamycin alone. Subjects may also receive oral antifungals after day 3 at the discretion of the treating clinician. All study subjects will be followed for 3 months to evaluate response to treatment.

Investigators from the University of California, San Francisco (UCSF) will assist Aravind Eye Hospital with the study design, implementation, and analysis of the research, and will help fund the study. The investigators will visit Aravind to help with the study implementation. UCSF will play an important role in this study by assisting with the study design, implementation, analysis, and funding.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe corneal ulcer that is smear positive for filamentous fungus
* Pinhole visual acuity worse than 20/70 in affected eye
* Basic understanding of the study as determined by the physician
* Commitment to return for follow up visits

Exclusion Criteria:

* Gram stain positive for bacteria or evidence of other concomitant infection (i.e. herpes, acanthamoeba)
* Impending or frank perforation at recruitment
* Involvement of sclera at presentation
* Non-infectious or autoimmune keratitis
* History of corneal transplantation or recent intraocular surgery
* No light perception in the affected eye
* Pinhole visual acuity worse than 20/200 in the unaffected eye
* Pregnant women
* Participants who are decisionally and/or cognitively impaired
Study Evaluating Cyclosporine Dose Reduction and Cyclosporine Elimination in Chinese Kidney Transplants

Evaluate the incidence of acute rejection at 12 months after transplantation in subjects receiving induction therapy with cyclosporine microemulsion (CsA) and Rapamune followed by CsA dose reduction (Phase I) with subjects receiving induction therapy with CsA and Rapamune followed by CsA discontinuation (Phase II) in Chinese de novo renal allograft recipients.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with end-stage renal disease scheduled to receive a primary renal allograft from a cadaveric donor, from a living-unrelated donor, or a living-related HLA-mismatched donor.
* Subjects must be at least 18 years of age.

Exclusion Criteria:

* Subjects with active major infection, including active hepatitis B or C infection, HIV, decreased platelets, elevated lipids, or multiple organ transplants.
Exercise and Nutrition on Obese Microbiome

The purpose of this study is to examine the effects nine weeks of intense exercise training will have on weight, inflammation, and intestinal bacteria composition of overweight and obese adults.


Eligibility Criteria:
Inclusion criteria:

1. Individuals who are overweight (BMI ≥ 25) and/or obese (BMI ≥ 30).
2. Individuals who volunteer for the 54-day exercise program.
3. Individuals with no history of diabetes mellitus (type I or II) or sickle cell disease.
4. Individuals who are not taking antibiotics and have not taken antibiotics within 3 months.
5. Individuals who are not taking probiotics.
6. Individuals who are not taking Metformin.
7. Individuals who are cleared by their physician to perform strenuous exercise.
8. Individuals with no physically debilitating injuries that would keep them from being able to perform the exercises prescribed.
9. Individuals who are between 18 and 60.

Exclusion criteria:

1. Any subjects who do not meet all of the inclusion criteria and/or are unable to consent.
Amlodipine vs Nitrates Study in Patients With Chronic Stable Angina

The objective of study is to compare the anti-ischemic efficacy and safety profiles of once daily amlodipine or isosorbide-5-mononitrate in the treatment of stable asymptomatic and symptomatic myocardial ischemia


Eligibility Criteria:
Inclusion Criteria:

* Outpatients \> =18 years of age with diagnosed clinically stable angina pectoris

Exclusion Criteria:

* Patients with congestive heart failure, clinically significant cardiovascular disease, standing systolic blood pressure of less than 100mmHg, concomitant anti-anginal therapies similar to sublingual NTG
Modified Technique in Sacrospinous Fixation for Treatment of Apical Genital Prolapse

Pelvic organ prolapse is one of the most common benign gynecological disorders and affects approximately 40% of women over 50 years of age. The causes of utero vaginal prolapse are pregnancy, labor, obesity, increased intra-abdominal pressure, and weak pelvic floor structures


Eligibility Criteria:
Inclusion Criteria:

1- Symptomatic Stage II , III and Stage IV Apical Prolapse (diagnosed by pop Q test ) .

Exclusion Criteria:

1. Patients with medical disorders that may interfere with surgical interventions ( Like severe chest and heart diseases , renal and liver cell failure , bleeding tendency ) .
2. Patients with urinary incontinence ( excluded by history , examination \& Urodynamics)
The Impact of Hip Exercises on Pelvic Floor Muscle Strength and Function in Older Women With Urinary Incontinence

This is a prospective cohort study of 30 older women ages 65 and older with urinary incontinence (UI) who will under go a standardized 12-week hip muscle exercises (isometric strengthening of hip external rotators with progressive resistance training).

This is a prospective cohort study of 30 older women ages 65 and older with urinary incontinence (UI) who will under go a standardized 12-week hip muscle exercises (isometric strengthening of hip external rotators with progressive resistance training). Participants will take part in a 12-week hip muscle exercise program (weekly supervised hip exercises with resistance progression) plus a home program with the same exercises 3 days per week. the exercise program will be administered by the licensed physical therapist with special focus in hip strength. The change in pelvic floor muscle strength (peak pelvic floor muscle squeeze pressures) pre- to post hip muscle exercises. Changes in UI symptom severity, and impact of UI symptoms on quality of life will be assessed. Objective measurement of pelvic floor muscle strength will be obtained using a perineometer. UI symptom severity and quality of life will be measured using validated questionnaires (PFDI and PFIQ, respectively).

Eligibility Criteria:
Inclusion Criteria:

* Women ages ≥65
* UI for at least the last 3 months UI will be defined using the following (a widely-accepted definition in epidemiologic studies) Scores 3 - 12 on the validated 2-item Incontinence Severity Index (ISI)

Exclusion Criteria:

* Women unable to follow-up, not willing to, or unable to participate in the exercise intervention program
* Prior or current treatment for UI including previous FDA approved medications for UI, prior surgery for UI within the past 12 months
* Pelvic organ prolapse beyond the hymen
* Potential causes or conditions associated with neurogenic bladder (multiple sclerosis, Parkinson's disease, stroke, spinal cord injury)
* Urinary retention, incomplete bladder emptying (via bladder scan, \>150mL post-void residual)
* Conditions (neurological or musculoskeletal) that compromise mobility, requiring assisted device for ambulation or wheel chair
* Diagnosis of dementia or cognitive impairment (Montreal Cognitive Assessment \[MoCA\] \<25, mild cognitive impairment)
By Pass Surgery With Stem Cell Therapy in Chronic Ischemic Cardiopathy

Surgical revascularization has proven its efficacy in term of morbidity and mortality in patients with multivessel coronary disease and poor left ventricular function. Nevertheless, if left ventricle is severely dilated, the improvement of global contractility and reduction of volumes is frequently absent after CABG even if substantial amount of myocardial viability is present. A value of \> 140 ml for end systolic volume has been proposed as the cut off for the absence of recovery after revascularization.

Recently, a reduction of cardiac volumes and improvement of regional and global contractility has been demonstrated in patients with advanced ischemic heart disease, severe dilation of left ventricle and poor candidates for revascularization after injection of stem cells in territories with residual viability.

The screening of patients will be performed after contrast coronar ventriculography realized for diagnostic or prognostic purpose.

Subsequently all patients will be evaluated by cardiac ce-MR and PET imaging for verification of inclusion criteria.

Patients will be allocated in a single blind manner to one of two therapeutic arms: surgical revascularization alone or surgical revascularization associated with autologous bone marrow derived stem cells injection in viable territories.

During the follow up evolution of left ventricular volumes and contractility will be analyzed by ce-MR and PET imaging at 1 year. Additionally patients' functional status will be assessed by metabolic stress tests and quality of life questionnaire at 6 months, 1 year and 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Chronic ischemic heart disease
* Left ventricular dilation (end systolic volume \>140 ml)
* Poor global contractile function (ejection fraction \<40%)
* Substantial amount of residual viability (\>30% of left ventricle)
Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels.

This study investigated the effect of dexmedetomidine in obese patients undergoing bariatric surgery.

A prospective, double-blind, randomized controlled trial was performed. Consenting obese adult patients with impaired glucose tolerance, undergoing bariatric surgery, were randomized, by a computer, to receive placebo (0.9% Sodium-chloride) or dexmedetomidine 1 ug/kg bolus in 10 minutes followed by an infusion of 0.5 ug/kg/h until the end of surgery. Baseline HgbA1c, glucose, and insulin plasmatic levels were measured. Subsequently, glucose and insulin levels were taken every 2 hours during the first 12 hours from the onset of the drug infusion. Intraoperative fentanyl and postoperative morphine consumption, pain score, the occurrence of emesis, and postoperative sedation levels were recorded as secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Obese patient (BMI\>30)
* American Society of Anesthesiologists grades II or III
* Diagnosis of impaired glucose tolerance
* Undergoing sleeve gastrectomy

Exclusion Criteria:

* Baseline glucose \> 200mg/dl
* Diagnosis of Diabetes
* Under corticosteroids treatment
* Oral hypoglycemic medication within 7 days previous surgery
* Use of insulin within 24h previous surgery
* Allergy to any drug used in the study
Goal-directed Fluid Management Versus Conventional Fluid Management in Laparoscopic Hysterectomy

Fluid management is critical in patients undergoing surgery. Goal-directed fluid management (GDFM) protocols have been shown to decrease the length of hospital stay. In this study, we aimed to compare the effects of conventional fluid management with Pleth Variability Index (PVI) guided on blood lactate, serum creatinine levels, postoperative kidney injury and the duration of hospital stay.

Fluid management is critical in patients undergoing surgery. Goal-directed fluid management (GDFM) protocols have been shown to decrease the length of hospital stay in various kinds of surgical procedures. In this study, we aimed to compare the effects of conventional fluid management with Pleth Variability Index (PVI) guided on blood lactate, serum creatinine levels, postoperative kidney injury and the duration of hospital stay. Patients will be randomized to one of the study arms: group1 (conventional fluid management arm) will receive 0.9 % NaCl at a rate of 4- 8 mL/kg/h, a 250-ml bolus crystalloid/ colloid injection will be administered when the mean arterial blood pressure (MAP) decreased below 65 mmHg.; group 2 (GDFM); group 2 (GDFM group) will receive 0.9 % NaCl at rate of 2 mL/kg/h, a 250-mL bolus crystalloid/colloid injection will be administered when PVI is higher than 13 % over 5 min. In both groups, when MAP is still \< 65 mmHg after fluid bolus infusion, 5 mg i.v. bolus ephedrine will be administered. The groups will be compared concerning postoperative blood lactate, serum creatinine levels, postoperative kidney injury and the duration of hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* Must be scheduled for laparoscopic hysterectomy Must be American Society of Anesthesiologists (ASA) class I-II-III

Exclusion Criteria:

- American Society of Anesthesiologists (ASA) class IV BMI \> 40 kg/m2 Non-sinus heart rhythm MAP \<65 mmHg at the onset of anesthesia induction Advanced renal and hepatic impairment Ejection fraction \< 50 % Massive bleeding in the perioperative period
CBT-I to Improve Functional Outcomes in Veterans With Psychosis

The goal of this project is to examine the efficacy of Cognitive Behavioral Therapy for Insomnia (CBT-I) for improving sleep and related functional outcomes in Veterans with psychosis and insomnia.

The goal of this project is to examine the efficacy of Cognitive Behavioral Therapy for Insomnia (CBT-I) for improving sleep and related functional outcomes in Veterans with psychosis and insomnia.

Aim 1: Evaluate the efficacy of CBT-I for reducing insomnia severity in Veterans with psychosis and insomnia.

Hypothesis 1: CBT-I participants, as compared to those in an active control condition, will show significantly greater reductions on the Insomnia Severity Index at post-treatment and at a 6-month follow-up.

Aim 2: Evaluate the efficacy of CBT-I for improving the functioning of Veterans with psychosis and insomnia. Hypothesis 2: CBT-I participants, as compared to those in an active control condition, will show significantly greater increases in mental and physical health functioning on the Veterans RAND 36-Item Health Survey at post-treatment and at a 6-month follow-up.

Aim 3: Evaluate the process that underlies the relationship between insomnia severity and functioning in Veterans with psychosis and insomnia.

Hypothesis 3: The effect of CBT-I on mental and physical health functioning at post-treatment will be mediated by reductions in insomnia severity at week 5 of treatment.

Hypothesis 4: The effect of CBT-I on mental and physical health functioning at the 6-month follow-up will be mediated by reductions in insomnia severity at immediate post-treatment.

Exploratory Aim: Explore whether psychiatric symptoms 1) moderate the impact of CBT-I on insomnia and functioning and/or 2) change as a result of participation in CBT-I.

Eligibility Criteria:
Inclusion Criteria:

* meet criteria for SMI: Schizophrenic disorder, affective psychosis, major depression with psychotic features, delusional disorder, brief psychotic disorder, unspecified psychotic disorder, schizotypal personality disorder
* be between the ages of 18 and 80
* be actively participating in outpatient mental health services at designated site

Exclusion Criteria:

* currently in CBT-I treatment
* planning to move out of the area during the study period
Effects of Internet-based Treatment of Pathological Gambling

A trial testing the outcome of an Internet-based treatment of pathological gambling with the hypothesis that there will be improvements both immediately and up to 36 months. It is also hypnotized that treatment response can be predicted from background variables.


Eligibility Criteria:
Inclusion Criteria:

* Pathological gambling according to DSM and having gambled at least once the past month
* Being atleast 18 years old
* Living in Sweden

Exclusion Criteria:
Sub Lingual Misoprostol Before IUD Insertion in Women With Only Previous Cesarean Section

The aim of the work is to evaluate the efficacy of the sub lingual prostaglandin E1 synthetic analogue (misoprostol) before IUD insertion to facilitate the procedure in patients delivered before only by cesarean section.

The study will be conducted at Ain Shams University Maternity Hospital. 124 women candidate for Cu T 380A IUD insertion will be enrolled in the study. Half of them will receive 400 micro gram of misoprostol (Sigma) sub lingually and the other half will receive the placebo two hours before IUD insertion.

Eligibility Criteria:
Inclusion Criteria:

* Normal size uterus.
* Willing to participate.
* Candidate for IUD insertion.
* Delivered only by cesarean section.
* Last delivery is more than 40 days before participating in the study.

Exclusion Criteria:

* Previous vaginal delivery
* Signs of genital infection.
* Menopause.
* Body mass index (BMI) \> 35 kg/m2.
* Contraindication to misoprostol.
* Copper allergy.
* Positive pregnancy test.
* Had a prior attempt for IUD insertion.
* Uterine anomalies.
* Uterine fibroid.