cyrilzakka/clinical-trials huggingface dataset:
The Incidence of Glistenings in the 2017 Intraocular Lenses Made by Alcon and Abbott Medical Optics

The purpose of this study is to seek academic/non-industry research funding support to independently investigate the incidence and density of lens glistenings in cataract patients who are implanted with the latest generations of intraocular lenses (IOL) manufactured by Alcon and AMO Medical Optics.

Glistenings are tiny, clear sparkling, fluid-filled microvacuoles that form within a lens after it has been placed in the eye. Glistenings are seen in all lenses but certain lenses develop a higher number of glistenings than others. The effect of glistenings on patients' visual functioning is largely unknown.

The occurrence of glistenings is in part related to the manufacturing technique. In 2013, manufacturers have claimed that recent improvements in manufacturing process have reduced the occurrence of glistenings. There is a lack of independent evaluation of this claim. We would like to assess independently: 1) How frequently do glistenings occur in patients implanted with the 2015 generation lenses? 2) Is there a difference in glistening occurrence between lenses manufactured by Alcon and Abbott Medical Optics (AMO) - the two largest companies in eye care products?

Two-hundred and seventy-six patients will be randomly assigned to receive Alcon or AMO lenses for their cataract surgery at the Kensington Eye Institute (KEI). After surgery, patients will be instructed to return for follow-up visits at 1 month, 6 months, 12 months and 18 months to assess for the occurrence of glistenings. If glistenings are observed at an earlier follow-up visit (e.g., the 6 month visit), patients will still be instructed to come for future visits so that changes in the glistenings over time can be observed.

Project Time-line:

Months 1-8: Participants recruiting, surgical operations, follow-up visits. Months 9-24: follow-up visits, data entry, cleaning and analysis, early results presentation, manuscript preparation and final report.

Eligibility Criteria:
Inclusion Criteria:

* Patients consulting 5 surgeons for cataract surgery in the surgeon's primary offices
* Patients aged 18 years or older
* Patients who signed the consent form

Exclusion Criteria:

* Individuals who cannot understand English in either written or verbal form and do not have language assistance available (e.g. from family members, friends)
* Patients with co-existing condition of corneal disease
* Patients with co-existing condition of uveitis
* Patients with co-existing condition of optic nerve disease
* Patients with co-existing condition of macular disease
* Patients with co-existing condition of diabetes
* Patients with co-existing condition of severe glaucoma (i.e. C/D ratio \>=0.9 AND the patient is on glaucoma treatment)
* Patients with prior refractive surgery
* Patients with complications of cataract surgery occurred during or after surgery
EtCO2 Level to Control Intraoperative Bleeding and Improve the Quality of Surgical Field Vision in Septorhinoplasty

It is unknown whether different end-tidal carbon dioxide pressure levels have a clinically significant effect on bleeding and surgical field quality in septorhinoplasty, especially during controlled hypotension. Therefore, it was aimed to investigate the effect of ventilation strategy with controlled hypocapnia on intraoperative bleeding and surgical field quality for commonly practiced in septorhinoplasty.

Septorhinoplasty is one of the most common esthetic surgeries in the world. The septorhinoplasty is accompanied by insignificant bleeding on the surgical field. Excessive bleeding compromises the surgical field quality and makes more difficult the septorhinoplasty. It is very important to control and minimize excessive bleeding in surgical field by different approaches of anesthesia management. Successful approaches to reduce the excessive bleeding are; controlled hypotension by keeping the mean arterial pressure in the range of 60-70 mmHg, the reverse Trendelenburg position of the patient, administration of adrenaline (injection prior to surgery or packing soaked during surgery), and administration of tranexamic acid, which are applicable methods in many clinical centers.

Cardiac output may vary depending on the autonomic nervous system. The dominance of parasympathetic system effect may cause vasodilation, decrease in blood pressure and cardiac output. This vasodilation may increase bleeding during septorhinoplasty and worsen the surgical field quality. Anesthesia management may provide a clear view for the surgeon and an improved surgical field quality. The effect of carbon dioxide on vascular reactivity deserves an extra attention in septorhinoplasty required bleeding control. The intensity of bleeding in septorhinoplasty is mainly affected by mean arterial pressure and heart rate. At the same time, blood flow can be affected directly by carbon dioxide on the smooth muscular tonus of the arterioles.

After all, it is unknown whether different carbon dioxide pressure levels have a clinically significant effect on bleeding and surgical field quality in septorhinoplasty, especially during controlled hypotension. Therefore, it was aimed to investigate the effect of ventilation strategy with controlled hypocapnia on intraoperative bleeding and surgical field quality for commonly practiced in septorhinoplasty.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists scores 1-3
* 18-65 years

Exclusion Criteria:

* American Society of Anesthesiologists scores IV,
* Under the age of 18,
* Over the age of 65,
* Using anticoagulant and antiplatelet drugs,
* Previous underwent septorhinoplasty operation,
* Obstetric conditions,
* Cardiovascular and pulmonary disease,
* Uncontrolled cerebrovascular disease,
* Allergic history to propofol, fentanyl, rocuronium, paracetamol, ibuprofen and tramadol,
* Refused written informed consent
Neuroendocrine Mechanisms of Developmental Massage Therapy (DMT) in Preterm Infants: Clinical Study

The purpose of this study is to see if daily massage therapy will help premature infants respond to stress better, as well as improve their growth and neurobehavioral development.

Optimal postnatal growth and development is essential for the survival and long-term health of infants born premature, however, growth and developmental delays are common. Many factors contribute to poor postnatal growth and development including immature organ systems, stress due to illness and even routine care in the neonatal intensive care unit environment. Massage therapy is associated with decreased cortisol levels during stress in a variety of populations including premature infants. Massage has also been reported to improve postnatal weight gain in premature infants. Concerns about methodological quality, however, weaken the credibility of previous studies and prevent the integration of massage therapy into conventional medical practice. Therefore, we plan to study the interrelationship of the ANS and HPA axis in preterm infants to assess how developmental massage therapy (DMT) modulates physiologic stability and promotes postnatal growth by the following specific aims:

SPECIFIC AIM 1: We will determine ANS balance, measured by heart period variability, before, during, and after DMT.

SPECIFIC AIM 2: We will compare the relationships between ANS balance and HPA response before and after DMT.

SPECIFIC AIM 3: We will evaluate somatotrophic response in premature infants who receive DMT.

Infants will be stratified by gender and randomized to receive developmental massage therapy or SHAM control.

This study will also allow for post-discharge assessment of development. Infants will return to the hospital at term, 3months and 6 months for multiple measurements and developmental testing.

Eligibility Criteria:
Inclusion Criteria:

* Premature infants born between 29 4/7 and 32 3/7 weeks gestation by physical exam at birth, and with birth weight, length and head circumference between the 5th and 95th percentiles for gestational age.

Exclusion Criteria:

* Intrauterine growth less than the 5th or greater than the 95th percentiles for gestational age, congenital anomalies, complex cardiac defects, severe CNS injury, hypothyroidism, inborn errors of metabolism, or inability to establish full enteral feeds by day of life 14.
Study Comparing Sequential Therapy of S1+Docetaxel Followed by S1 to Concomitant S1+Docetaxel for Advanced Gastric Cancer

Stage 1:First line therapy Sequential therapy of S1+Docetaxel followed by S1 is superior to concomitant S1+Docetaxel in the safety and clinical efficiency.

Stage 2:Second line therapy To explore the feasibility of single drug(S1) maintenance treatment for advanced gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form
* Performance Status-Eastern Cooperative Oncology Group (ECOG) 0-1
* Histologically or cytologically confirmed gastric cancer
* Advanced or recurrent, metastatic disease
* At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors )
* Life expectancy of at least 3 months
* Target target lesion has not received radiotherapy or non target lesion radiation at least 4 weeks
* Haematopoietic and Hepatic status:

Absolute neutrophil count \>1.5x109/L,Platelet count \> 100 x 109/L,Hemoglobin at least 9 g/dl,Bilirubin ≤ 1.5 x upper limit of normal (ULN),AST and ALT ≤ 2.5 times ULN(no liver metastasis), ≤5 times ULN(with liver metastasis)

* Cardiovascular: Baseline LVEF 50% measured by echocardiography

Exclusion Criteria:

* Symptomatic brain metastasis
* Active or uncontrolled infection
* Unresolved or unstable, serious toxicity from prior cancer treatment (any toxicities greater than grade 2; peripheral neuropathy of grade 2 or greater Symptomatic brain metastasis
* Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, uncontrolled hypertension (≥ 180/110), unstable diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen
* History of other malignancy
* Pregnant or lactating women
Clinical Trial of Pregabalin and COX2 in Spinal Stenosis

Aim of this prospective, single-blind, randomized study was to compare the efficacy of the combination of celecoxib and pregabalin and celecoxib only monotherapy for treatment of chronic low-back pain.

The efficacy and safety of the association of celecoxib \[a selective cyclooxygenase-2 (COX-2) inhibitor\] and pregabalin (commonly used to control neuropathic pain), compared with monotherapy of each, were evaluated for the treatment of chronic low-back pain, a condition known to be due to neuropathic as well as nociceptive pain mechanisms.

We will compare the efficacy of the combination of a selective COX-2 inhibitor (celecoxib) and an antineuropathic drug, pregabalin, versus celecoxib only monotherapy, in the treatment of spinal stenosis.

Each treatment lasted 8 weeks

Primary outcome is mean pain reduction following different treatments regimes. Secondary outcomes are the changes of pain sensitivity, Oswestry disability index, adverse effects due to the treatments under study.

Eligibility Criteria:
Inclusion Criteria:

* Spinal stenosis

Exclusion Criteria:

* Koval grade \>=3
* Other musculoskeletal disorders which cause pain on other joint
* Bleeding risk or ulcer history
* Severe cardiovascular, pulmonary, renal, brain, liver dysfunction
Vestibular Stimulation in Parkinson's Disease

The purpose of this study is to determine whether caloric vestibular stimulation improves symptoms of Parkinson's Disease.

Parkinson's Disease (PD) is a nationwide public health problem, inflicting a complex constellation of physical and neuropsychiatric symptoms which are shown to progress with time. This research will investigate the potential of caloric vestibular stimulation (CVS), a non-invasive form of brain stimulation, as a treatment for individuals who suffer from Parkinson's Disease. Investigators will investigate whether core cognitive and physiological deficits are responsive to stimulation by comparing participants' performance on behavioral and physiological measures after baseline and either active or placebo stimulation phases with the aim of drawing initial insights into the application of CVS within this population. The study design is based on a single-case study that recently demonstrated durable, clinically meaningful gains in the motor and nonmotor symptoms of PD.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be diagnosed with idiopathic Parkinson's Disease as defined by the UK PDS Brain Bank Criteria.
* Participants must report limitations to Activities of Daily Life (ADL, UPDRS subscale 2)
* Capacity to consent to the study
* Motivated to comply with the protocol
* An understanding of English sufficient to comply with the protocol
* Spouse/ carer willing to support the participant throughout the study

Exclusion Criteria:

* Diagnosis of induced Parkinson's or essential/dystonic tremor
* Premorbid psychiatric history (including affective disorder, psychosis or deliberate self- harm)
* Previous exposure to neurostimulation
* Inner ear pathology
Quality Improvement to Reduce Mortality or Severe Intracranial Hemorrhage in Neonatal Extracorporeal Life Support

This is a three-year pre- and post- interventional study to assess the effectiveness of collaborative quality improvement interventions on reducing mortality and severe intracranial hemorrhage (ICH) for neonates receiving extracorporeal life support (ECLS) in China.

This is a three-year pre- and post- interventional study from 2022 to 2024. The population of this study will be all neonates who receive ECLS support within 28 days of life in the participating hospitals of Chinese Neonatal Extracorporeal Life Support Registry (Chi-NELS). The intervention will be collaborative quality improvement interventions for each of the participating hospital. Detailed interventions include standardized ECLS data feedback and benchmark, establishment of potential better practice list, training on quality improvement, implementation of practice change using plan-do-study-action cycles, report and monitor of practice change and collaborative learning. The first year will be pre-intervention baseline period and serves as the control period. Collaborative quality improvement interventions will be introduced from the start of the second year and the second and third years will be the intervention period. The primary outcome, which is the incidence of mortality or severe ICH of the third year, will be compared to that of the baseline year.

Eligibility Criteria:
Inclusion Criteria:

* ≤28 days of life
* receive ECLS support

Exclusion Criteria:

* Infants with severe congenital anomalies
* Infants with pre-ECLS ICH
Development of the General Scale Observance for Chronic Diseases

The main objective is to assess the measurement characteristics (validity, reproducibility) and the invariance of EGOMAC scale in a population of consultants in diabetology, cardiology and rheumatology hospital and liberal and hospital oncology and Infectious disease, by following the evolution of patient compliance at D0 and D15.

The second objective is to assess the sensitivity to change of scale EGOMAC following developments compliance 3 months.

During a routine appointment (D0), the patient filled a newsletter and a questionnaire to complete.

The doctor collects medical informations for the case report form.

At the end of the first consultation (D0), an additional EGOMAC scale and a stamped envelope is delivered to the patient by asking him to fill that scale to 15 days and return it by Post Office (reproducibility study).

Finally, a new scale will be addressed to the patient at the end of 3 months, which will return by Post Office too (stability study).

Eligibility Criteria:
Inclusion Criteria:

* patient age of 18 years
* from routine patient counseling
* with at least one of these diseases : heart failure, hypertension, coronary disease, type 2 diabetes, osteoarthritis of the knee or hip, osteoporosis, inflammatory rheumatism (rheumatoid arthritis, spondyloarthropathy), cancer ( with only non-hormonal oral anti cancer treatments) and HIV.
* patient can read the French language in order to complete the self -administered questionnaire
* patient agreeing to participate in the study

Exclusion Criteria:

* patient treated for more than 3 conditions mentioned in the inclusion criteria (
* patient receiving no drug prescription or recommendation of lifestyle or diet (for example consultationpurely diagnostic ).
Patent Foramen Ovale in Cryptogenic Stroke Study

The study sought to assess the rate of recurrent stroke and death in stroke patients with a patent foramen ovale randomized to treatment with warfarin or aspirin. This was a multicenter study conducted at 48 U.S. Institutions.


Eligibility Criteria:
Inclusion Criteria:

* Age 30-85
* Ischemic stroke within 30 days
* Glasgow outcome scale ≥ 3
* No contraindications to warfarin/aspirin

Exclusion Criteria:

* Basal INR \> 1.4
* Post-procedural stroke
* Severe carotid atherosclerosis
* Cardioembolic stroke
* Contraindications to transesophageal echocardiography
Gynaecological Follow-up of Women With Down Syndrom Aged 18 to 30 in France

Gynaecological check-ups for women are recommended in France. However, some groups of the population are affected by a lack or absence of medical surveillance.

In France, there are one million people with an intellectual disability, including 50,000 with Down syndrome.

Although this disability causes numerous physical and psychological deficits, no gynaecological consequences have yet been demonstrated.

Regular gynaecological check-ups are therefore necessary, according to French recommendations.

However, several studies have shown that women with mental illness receive less or no gynaecological care.

The aim is to describe the gynaecological follow-up of women with Down syndrom in France.

Eligibility Criteria:
Inclusion Criteria:

* women with Down's syndrome,
* aged between 18 and 30,
* whether or not they are being followed up in a medical facility,
* who agree to take part in the study.

Exclusion Criteria:

* women with a disability other than Down's syndrome
* Not agreeing to take part in the study
Live Stream of Prehospital point-of Care Ultrasound by Air Rescue Physicians

Background: Point-of-care ultrasound (POCUS) has been suggested as a useful tool in emergency medicine for diagnosis and treatment of reversible causes. However, in prehospital setting performing ultrasound and the translation of the findings can be challenging. As new prehospital ultrasound devices offer the possibility for remote supervision, the impact of tele-supervision on time to diagnosis of critically ill patients is unclear.

Aims: The aim of this study is to evaluate the impact of tele-supervision on the time of POCUS in prehospital critically ill patients by air rescue physicians.

Methods: In total 100 critically ill patients suffering from acute dyspnoea, circulatory failure or trauma, which are treated by air rescue physicians will be included in this study. Duration of ultrasound performance as well as altered treatment strategies will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

Critically ill patients suffering from acute dyspnoea, circulatory failure or trauma will be included.

Patients with acute dyspnoea will be included, if they show at least one of the two following signs of respiratory failure:

* Respiratory rate \> 20 breaths per minute
* Peripheral oxygen saturation without oxygen supplementation \< 90%

Patients with acute circulatory failure will be included, if they show at least one of the following signs:

* Hypotension (systolic blood pressure \<90mmHg)
* Altered tissue perfusion (cold, clammy, mottling skin or altered mental status)

Trauma patients will be included, if at least one cause is suspected:

* Intraabdominal fluid
* Intrathoracic free fluid
* Pneumothorax

Exclusion Criteria:

* age under 18
* if POCUS will lead to a delay of live-saving treatment or transportation
Antibiotic Resistant Community-Acquired E. Coli

The purpose of this study is to review patients with E. coli infections at UPMC from January 1, 2004 to December 31, 2005 to determine if these infections have arisen in the community rather than in hospitals or nursing homes. The occurrence of such resistant isolates could be devastating if they were associated with bloodstream infection, such as sometimes accompanies urinary tract infection, since antibiotic resistant E. coli is not suspected in isolates coming from the community.

The following variables will be followed: age, sex, hospital location at the time of positive culture (ER, medical ward, ICU etc), prior hospitalization or nursing home admission, receipt of outpatient dialysis or other regular medical care (eg, outpatient chemotherapy), presence of invasive devices, receipt of antibiotics, including their type and whether they were adequate for the resistance profile of the organism, prior positive microbiologic cultures.

Eligibility Criteria:
Inclusion Criteria:

* ll patients with E. coli infections during the time period of the study will be reviewed. A community-associated E. coli isolate will be defined as one which was recovered from a clinical culture from a patient at UPMC-P who had no established risk factors for infection with an antibiotic resistant organism.

Established risk factors are defined as:

* Isolation of the organism two or more days after admission for hospitalization OR A history of hospitalization, surgery, dialysis, or residence in a long-term care facility within one year before the culture date
* OR The presence of an indwelling catheter or percutaneous medical device (eg, tracheostomy tube, gastrostomy tube, or Foley catheter) at the time of the culture
* OR Previous isolation of an antibiotic resistant organism
Phase 1 Study of Intravitreal Autologous CD34+ Stem Cell Therapy for Retinitis Pigmentosa

In this Phase 1 open-labeled prospective study, one eye of each participant with vision loss from retinitis pigmentosa will be administered intravitreal injection of autologous CD34+ stem cells harvested from bone marrow. Each participant will be examined serially for 6 months after study injection to determine safety and feasibility of this intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years of age 2. Visual Acuity at Presentation of 20/100 to Counting Fingers or constriction of peripheral visual field 360 degrees to \<10 degrees by perimetry if BCVA is better than 20/100, duration of vision loss \> 3 months 3. Vision loss due to retinitis pigmentosa 4. The study eye has the worse visual acuity or peripheral constriction. 14. Able and willing to sign consent 15. Able to keep follow-up appointments for at least 6 months

Exclusion Criteria:

1. Other concurrent optic nerve or retinal disease in study eye affecting vision
2. History of active retinal or choroidal neovascularization or macular edema in study eye requiring on-going intravitreal or periocular therapy in study eye
3. Active eye or systemic infection
4. Significant media opacity in the study eye precluding view of the fundus for examination, photography or optical coherence tomography (OCT)

9. Other cause for vision loss in the study eye 10. History of coagulopathy or other hematologic abnormality 11. Use of coumadin within 3 days of enrollment 12. Concurrent immunosuppressive therapy 13. History of allergy to fluorescein dye