cyrilzakka/clinical-trials huggingface dataset:
Dysphotopsia Following Laser Peripheral Iridotomy

To establish the correlation of the location of the Nd:YAG laser peripheral iridotomy to the post operative visual symptoms experienced by some patients. The investigators hypothesize that fully uncovered laser peripheral iridotomy will produce less significant dysphotopsia, due to avoidance of the prismatic effect produced by the tear film than those covered.

Nd:YAG LPI is a frequently performed procedure for patients who have narrow angles at risk of acute angle closure glaucoma, pupillary-block conditions, chronic angle closure, and pigment dispersion syndrome. Most complications associated with the procedure are benign and include intraocular pressure (IOP) spike, transient uveitis, hyphema, corneal or lens damage and closure of the iridotomy. Visual disturbances have been also reported but only a few papers address this specific issue. The rate of these symptoms vary between 2.7% and 4%. It is believed that these symptoms are associated with the fact that light enters through the LPI and thus creating abnormal visual symptoms. Hence it has been suggested to carefully place the LPI so that the eyelid fully covers the LPI, therefore preventing light getting through. However, reports of patients with fully covered LPIs and visual disturbances have led to hypothesize the theory that even when fully covered by the eyelid, light can access through the LPI by a base-up prism created by the tear meniscus at the lid margin. Therefore, placement of the LPI, fully covered, partially covered or totally uncovered can potentially lead to equally significant symptoms. This study will attempt to address the issue of placement of the LPI in relationship with visual symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Able and willing to make the required study visit
* Able and willing to give consent and follow study instructions
* An indication to undergo laser peripheral iridotomy (narrow angles, occludeable angle at risk of acute angle closure, pupil block condition, chronic angle closure, pigment dispersion syndrome)

Exclusion Criteria:

* Previous intraocular surgery
* Best corrected visual acuity worse than 20/40
* Asymmetrical ptosis of more than 2mm
* Any active intraocular inflammation
* Acute attack of angle closure glaucoma
Evaluation of Retinal and Vascular Features in Radiation Maculopathy After Intravitreal Injections of Ranibizumab

This study evaluates the retinal and vascular features in patients with radiation maculopathy under the effects of Ranibizumab intravitreal injections using optical coherence tomography and optical coherence tomography angiography.

The radiation maculopathy is a consequence of radiotherapy for treatment of choroidal melanoma. The radiation maculopathy is characterized by the compromission of the macular microvasculature that can lead to the leakage, lipid exudates, hemorrhages, teleangiectasie, macular edema, non perfusion areas with consequent significant impaiment of visual acuity.

Ranibizumab is a vascular endothelial growth factor antagonist and it represents an efficacy treatment acting on vascular hyperpermeability. The optical coherence tomography and optical coherence tomography angiography represent novel and non-invasive diagnostic techniques that allow a detailed analysis of retinal and vascular features. The study evaluates the changes in optical coherence tomography and optical coherence tomography angiography parameters at baseline and after intravitreal injections of Ranibizumab at the last follow up to one year in patients affected by radiation maculopathy.

Eligibility Criteria:
Inclusion Criteria:

* age older than 40 years
* diagnosis of radiation maculopathy
* treatment-naïve with Ranibizumab
* absence of other vitreoretinal and vascular retinal diseases

Exclusion Criteria:

* age younger than 40 years
* No diagnosis of radiation maculopathy
* previous treatments with Ranibizumab
* presence of vitreoretinal and vascular retinal diseases
Telmisartan 80mg Non-responder Trial

If a patient cannot have his or her blood pressure controlled with telmisartan 80 mg, an antihypertensive drug from different class should be started concomitantly.

In the Japanese 3x3 factorial trial of telmisartan and hydrochlorothiazide in essential hypertension patients whose diastolic blood pressure (DBP) are equal or more than 95 mmHg, the DBP control rate (less than 90 mmHg) after 8 weeks treatment of the telmisartan 80 mg monotherapy group (66 patients) was 41.5%. There should be medical needs of the telmisartan 80 mg and amlodipine 5 mg fixed dose combination because some patients cannot have his or her blood pressure controlled with telmisartan 80 mg.

Thus, this clinical trial is being conducted to evaluate the antihypertensive effect and safety of a fixed-dose combination (FDC) drug of 2 antihypertensive agents with different pharmacological effects, telmisartan 80 mg and amlodipine 5 mg (T80/A5 mg), compared with telmisartan 80 mg (T80 mg) monotherapy in Japanese patients with essential hypertension who fail to respond adequately to treatment with the maximum dose of telmisartan 80 mg monotherapy. In this trial, a multi-centre, randomised, double-blind, double-dummy, active-controlled, parallel group comparison method is employed.


Eligibility Criteria:
Inclusion criteria:

* Essential hypertensive patients

  * If already taking antihypertensive drugs, mean seated diastolic blood pressure (DBP) must be \>=90 and \>=114 mmHg
  * If not taking any antihypertensive drugs, mean seated DBP must be \>=95 and \>=114 mmHg
* Able to stop all current antihypertensive drugs without risk to the patient based on the investigators opinion.

Exclusion criteria:

* Patients taking 3 or more antihypertensive drugs at signing the informed consent form
* Patients with known or suspected secondary hypertension
* Patients with clinically relevant cardiac arrhythmia
* Congestive heart failure with New York Heart Association (NYHA) functional class III-IV
* Patients with recent cardiovascular events
* Patients with a history of stroke or transient ischaemic attack within last 6 months before signing the informed consent form
* Patients with a history of sudden deterioration of renal function with angiotensin II receptor blockers (ARBs) or angiotensin converting enzyme (ACE) inhibitors; or patients with post-renal transplant or post-nephrectomy
* Patients who have previously experienced characteristic symptoms of angioedema (such as facial, tongue, pharyngeal, or laryngeal swelling with dyspnea) during treatment with ARBs or ACE inhibitors
* Patients with known hypersensitivity to any component of the investigational product, or a known hypersensitivity to dihydropyridine-derived drugs
* Patients with hepatic and/or renal dysfunction
* Pre-menopausal women who are nursing or pregnant
Gaining Insight Into Dual Sensory Loss

The goal of this observational study is to explore difficulties in information access, mobility, communication and fatigue in people with combined vision and hearing impairments. The main question it aims to answer is:

• What influence do varying severities of vision and hearing loss have on information access, mobility, communication and fatigue.

Participants will fill out questionnaires and the researchers will measure their vision and hearing functions.

People with dual sensory loss have impairments in both vision and hearing. When the impairments are severe, it will become more difficult to compensate for these impairments. This can result in difficulties, for example in the areas of access to information, communication, fatigue and/or mobility. Now, we do not know which problems arise from different combinations and levels of impairments in visual acuity, contrast sensitivity, visual field, hearing threshold, directional hearing and speech understanding. We also do not know how this influences the areas of access to information, communication, fatigue and mobility.

The objective of this study is to determine which problems arise from different levels of impairments in visual and auditory functions. We will especially focus on the areas of access to information, communication, fatigue and mobility.

Study design

Participants' visual (visual acuity, visual field, contrast sensitivity) and auditory functions (hearing threshold, directional hearing, speech understanding) will be measured. We will use the following materials:

* ETDRS card
* Vistech card
* Octopus perimeter
* Affinity compact audiometer
* 8 Genelec 8020 DPM speakers (to measure directional hearing)
* Digits in Noise (DIN) test and NVA word lists

Several questionnaires will be filled out to measure difficulties in the areas of access to information, communication, fatigue and mobility:

* Dutch ICF Activity Inventory - domains watching TV, using a computer, using a telephone, mobility outdoors (walking), using public transportation and feeling fit
* Speech, Spatial and Qualities of Hearing Scale
* Spatial Localization Questionnaire
* Fatigue Assessment Scale

Study population:

* 150 people with dual sensory loss
* 50 people with a visual impairment
* 50 people with an auditory impairment
* 50 people with normal vision and hearing

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years
* Good understanding of the Dutch language
* Clients: visual and/or auditory impairment (congenital or acquired)
* Other participants: normal vision and hearing

Exclusion Criteria:

* Impaired cognitive functioning
Retrieval of Hepatitis C Patients Lost to Follow-up

The main purpose of the study is to compare the efficacy of two strategies aimed to rescue patients lost to follow-up with active infection or with positive HCV antibodies without RNA request to complete evaluation and prescription of treatment in cases of chronic infection. After patient identification from data files of laboratory and microbiology charts, patients will be randomized to: a) phone call, and b) invitation letter, both of two strategies including a scheduled appointment with the hepatologist.

This is a prospective, randomized study in which subjects lost to follow-up with positive HCV antibodies without RNA request or positive RNA will be proposed to be brought back into care.

After patients identification from data files of laboratory and microbiology charts using three different cohorts in time (2005-07, 2011-11 and 2015-17), eligible patients (18 years of age or older, patients positive for HCV antibodies without RNA request or positive RNA lost to follow-up, with a valid sanitary card in our public health system and with available data for contact) will be randomized to: a) phone call (Strategy 1), and b) invitation letter (Strategy 2), both of two strategies including a scheduled appointment with the hepatologist.

Strategy 1 includes until three phone calls to contact patients and provide them with an appointment with the hepatologist (tertiary care center) over a period of 14 days according to patient availability. Instead, strategy 2 includes an invitation letter providing patients with the appointment with the hepatologist over a same period of time than strategy 1. If there is no response to calls or no attendance to the appointment after the letter (randomized strategy), the strategy will be switched to the another one.

Epidemiological, clinical, and laboratory variables will be registered.

The hypothesis of the study is that phone calls will improve the rate of linkage to care among HCV patients lost to follow-up compared to the invitation letter shipment. Therefore, call would be an effective strategy to rescue these patients.

For the present study, a 15% of improvement in linkage to care was hypothesized in the group of patients receiving the strategy 1 compared with the strategy 2. Taking into account a power of 80%, alpha error of 5% and losses of 10% will require 176 patients per strategy.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Record of positive HCV antibodies without RNA request or positive RNA lost to follow-up (non-treated patients with an active infection, without surveillance by any HCV specialist)
3. Patients a valid sanitary card in our public health system
4. Patients with available data for contact)

Exclusion Criteria:

1. Belong to another catchment area. Current surveillance by any HCV specialist and/or record of sustained virological response.
2. Severe comorbidity with an expected survival lower than 1 year.
Impact of Ambulatory Continuous Monitoring Using Remote Monitoring Medicine Within Patient's Care Pathway Following Colorectal Surgery (CONTACT-GRECCAR 21)

The goal of this Clinical Investigation is to evaluate the effectiveness of implementing the discharge protocol of the remote monitoring platform after colorectal surgery in patients at risk of hospital readmission.

Participants will be randomized into either the "30 days of remote monitoring" group or the "conventional discharge" group. The patient returns to the site for their postoperative visit at 30 days and is contacted by phone 90 days after their surgery.


Eligibility Criteria:
Inclusion Criteria :

* Man or woman over 18 years old at the time of the J0 visit,
* Patient who has undergone colorectal surgery not managed on an outpatient basis at the investigator center,
* At least one of the following two criteria:
* Anticipated early discharge (within 24 hours following laparoscopic surgery without diversion and within 5 days following surgery by laparotomy with stoma) for a surgery not managed on an outpatient basis in routine practice,
* Estimated risk of hospital readmission greater than 10% according to the nomogram of Tevis et al. \[15\], adapted to the postoperative context in digestive surgery (\>120 points according to this score).
* Patient affiliated with a health insurance plan,
* Patient who has signed the study consent form.

Exclusion Criteria:

* Discharge to a rehabilitation center requested by the patient,
* Condition managed on an outpatient basis in routine practice for this type of patient,
* Patient eligible for home hospitalization services,
* Suicidal or hetero-aggressive risk in a patient living alone at home
* Homeless patient,
* Pregnant or breastfeeding women,
* Patient under legal guardianship, curatorship, or protected legal status,
* Patient already enrolled in an interventional postoperative follow-up study.
Serum Sex Hormone Levels and Subclinical Atherosclerosis - Ancillary to MESA

To assess the associations of serum sex hormones with the presence and progression of subclinical atherosclerosis.

BACKGROUND:

Throughout their lifetime, men are at higher risk of coronary heart disease (CHD) than women, however, after menopause this difference is attenuated. This observation suggests that endogenous sex hormones could be associated with CHD risk. There is some evidence indicating that the effect of sex hormones on CHD risk could be mediated, in part, by alterations in lipid levels or other CHD risk factors. However, other evidence supports an independent relationship of circulating hormone levels with CHD risk.

DESIGN NARRATIVE:

The study, which is ancillary to MESA, will examine the associations of serum sex hormone concentrations with the presence and progression of subclinical atherosclerosis in 3,259 male and 2,802 postmenopausal female participants of the Multi-Ethnic Study of Atherosclerosis (MESA). Subclinical atherosclerosis will be identified using both coronary artery calcium (CAC) and carotid intimal-medial wall thickness (IMT). Progression will be identified by the change in CAC over 3.5 years. Circulating concentrations of total (and free) testosterone (T), dehydroepiandrosterone (DHEA), 17 beta-estradiol (E2), and sex hormone binding globulin (SHBG) in stored serum samples collected at the MESA baseline exam will be assessed. Laboratory results will be merged with existing demographic, anthropometric, lifestyle, CHD risk factor, and subclinical disease data collected in MESA. Cross-sectional and prospective methods of statistical analysis will be used to assess the proposed associations. MESA is particularly well suited for disentangling the effects of hormonal factors and CHD risk factors on subclinical atherosclerosis because of the availability of high-quality data, serum samples, and CAC and IMT measurements in a large multi-ethnic population of men and women.

Eligibility Criteria:
Exclusion Criteria:

* Age younger than 45 or older than 84 years
* Physician-diagnosed heart attack
* Physician-diagnosed angina or taking nitroglycerin
* Physician-diagnosed stroke or TIA
* Physician-diagnosed heart failure
* Current atrial fibrillation
* Having undergone procedures related to cardiovascular disease (CABG, angioplasty, valve replacement, pacemaker or defibrillator implantation, any surgery on the heart or arteries)
* Active treatment for cancer
* Pregnancy
* Any serious medical condition which would prevent long-term participation
* Weight \>300 pounds
* Cognitive inability as judged by the interviewer
* Living in a nursing home or on the waiting list for a nursing home
* Plans to leave the community within five years
* Language barrier (speaks other than English, Spanish, Cantonese or Mandarin)
* Chest CT scan in the past year
Clinical Study to Evaluate the Efficacy and Safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura in Adults

Octagam is a solvent/detergent-treated human normal immunoglobulin (IGIV) solution for intravenous administration. Octagam 5% is currently registered in about 80 countries. This study evaluated the efficacy and safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura (ITP) in adults. As Octagam 10% is essentially similar to Octagam 5%, it is expected that Octagam 10% is as efficacious and safe (in respect to viral safety) as Octagam 5%.

The primary objective of the study was to investigate the efficacy of Octagam® 10% in correcting platelet count. The blood count as well as laboratory chemistry were checked repeatedly up to day 21.

The secondary objective of the study was to investigate the safety of Octagam® 10%. Safety was assessed by monitoring vital signs, evaluating adverse events, assessing laboratory parameters, and by viral safety testing.

Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of Idiopathic Thrombocytopenic Purpura (ITP) according to standard criteria.
* Platelet count ≤ 20 x 10\^9/L.

Key Exclusion Criteria:

* Chronic refractory ITP patients.
* Thrombocytopenia secondary to other diseases, or drug related thrombocytopenia.
* Administration of IGIV, anti-D, or other platelet enhancing drugs within 30 days before enrollment.
* Administration of thrombocyte concentrates within 72 hours before baseline.
* Experimental treatment (eg, rituximab) within 3 months before enrollment.
* Prophylactic preoperative treatment for elective splenectomy.
* Severe liver or kidney disease.
* Pregnant or nursing female.
* History of hypersensitivity to blood or plasma derived products.
* Emergency operation.
* Live viral vaccination within the last month prior to study entry.
* Known IgA deficiency and antibodies against IgA.
Analgesia by Transversus Abdominis Plane Nerve Block in Patients Undergoing Liver Resection.

The indications liver cancer surgery currently booming due to the increase in surgical techniques and instruments for a more secure resection of liver tissue with a significant reduction in bleeding or surgical complications. This allowed to expand surgical indications in the most fragile patients so assuming optimized anesthetic care.

So far, the technique of analgesia reference to this surgery remains administration of morphine analgesia via a device controlled by the patient (PCA) for epidural analgesia is against-indicated because of induced bleeding disorders by surgery.

Rafi then McDonnell in 2007 have described a new technique of loco regional anesthesia, the abdomen of the Transversus Abdominis Plane (TAP) nerve block(TAP), which allows selective anesthesia of the abdominal wall. But parietal pain related muscular and nervous sagging surgical approach represent a significant share of post operative pain.

This study proposes an evaluation of the abdomen transverse blocks in hepatectomy.


Eligibility Criteria:
Inclusion Criteria:

* hepatectomy or segmentectomy

Exclusion Criteria:

* Sepsis uncontrolled current
* Overdose in anticoagulant during general anesthesia
* Thrombocytopenia \<50 g / dl
* Severe renal impairment: Cockcroft \<30 ml / min
* history of ventricular arrhythmia serious unexplained .\*
* Allergy to local anesthetics of the amide
* Contraindication to remifentanil and morphine
* Hypovolemia
Impact of Mental Health and Cognitive Disorders on Quality of Life in Severe Covid-19 Survivors

The objective of this single-center retrospective observational study is to describe cognitive and psychological outcomes and their impact on quality of life after at least 3 months of intensive care unit (ICU) discharge in severe COVID-19 survivors.

Background: The COVID-19 pandemic has already affected more than 600 million people worldwide and resulted in at least 6 million deaths (https:coronavirus.jhu.edu/map.html). The pandemic has also resulted in a growing population of individuals recovering from acute SARS-CoV-2 infection. Accumulating observational data suggest that these patients often experience a wide range of symptoms after recovery from acute illness. The dysfunctions ranging from motor, cognitive disability, anxiety, depression and post-traumatic stress disorder. However, there is still unknown data about the occurrence of mental health manifestations after a critical illness and their consequences in mid term quality of life.

Purpose: Many patients with coronavirus disease 2019 (COVID-19) required critical care. Mid-term outcomes of the survivors need to be assessed. The objective of this single-center retrospective observational study is to describe their cognitive and psychological outcomes and their impact on quality of life afer at least 3 months following intensive care unit (ICU)-discharge.

Objectives: Our objective will be to evaluate the incidence of non-physical post-intensive care syndrome, such as symptoms of anxiety, depression, cognitive and post-traumatic stress disorder (PTSD) after hospital discharge in our severe COVID-19 population, as well as determining their long-term consequences in quality of life (QoL).

Methods: An observational retrospective study will be conducted, including all patients with severe COVID-19 admitted to the intensive care unit of a private tertiary hospital from April 2020 to October 2021. Patients were routinely assessed after 3 months of ICU discharge in our multidisciplinary follow-up clinic. A trained research team routinely applied the Montreal Cognitive Assessment Scale (MOCA), Hospital Anxiety and Depression Scale (HADS), PCL-C (Post-traumatic Stress Disorder Checklist: Civilian Version) and Short Form Health Survey 36 (SF-36), during the follow-up evaluation.

Eligibility Criteria:
Inclusion Criteria:

* All 18 years and older patients with severe COVID-19, confirmed by real-time reverse transcriptase-polymerase chain reaction., admitted to a 15- bed intensive care unit of a tertiary hospital from April 2020 to October 2021.

Exclusion Criteria:

* Still hospitalized or inpatient in rehabilitation facility
* Previous cognitive impairmant