cyrilzakka/clinical-trials huggingface dataset:
Handheld Device Compared With a Standard Eye Care Diagnostic Device in Measuring Ophthalmic Refraction

This study is exploratory and examines whether the best-corrected visual acuities (BCVA's) from trial frames created with the refraction results obtained from a novel handheld optical device yields results similar to the ophthalmic refraction obtained from an autorefractor in healthy volunteers age stratum of 18 through 65 years.

This study is exploratory and examines whether the best-corrected visual acuities (BCVA's) from trial frames created with the refraction results obtained from a novel handheld optical device yields results similar to the ophthalmic refraction obtained from an autorefractor in healthy volunteers age stratum of 18 through 65 years.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* Ages =\>18 y.o. and =\<65 y.o.
* Binocular vision
* Willing and able to give informed consent and follow all study procedures and requirements
* Fluent in English

Exclusion Criteria:

* Has been diagnosed within 4 weeks, or currently has signs or symptoms, of COVID-19.
* Has traveled outside the country within the last 4 weeks.
* At the discretion of the investigator: Age strata has achieved minimum evaluable population.
* Spherical correction \> +8 or \< -10
* Using anticholinergic medications (including first-generation antihistamines) or other medications known to affect visual acuity within the greater of 3 days or 5 half-lives prior to enrolling in this study
* Using an investigational drug or approved therapy for investigational use within the greater of 3 days or 5 half-lives prior to enrolling in this study
* Has initiated any new medication in the past 2 weeks that, in the best medical judgment of the investigator, would impact their participation in the study or ability to use the EyeQue EQ103 device
* Any self-reported mental illness or condition, including but not limited to:

claustrophobia, fear of simulators, nyctophobia.

* Any self-reported neurological diseases, including but not limited to: epilepsy, Alzheimer's, nystagmus

Per subject self-reporting: eye disease, including but not limited to:

* Glaucoma
* Cataracts
* Macular degeneration
* Eye infection (by self-report or observation)
* Keratoconus
* Diabetic neuropathy/retinopathy
* Cytomegalovirus retinitis
* Color blindness (any color deficiency)
* Diabetic macular edema
* Amblyopia
* Chronic or acute uveitis
* Strabismus
* Astigmatism \> 3 diopters
* Macular hole

Subjects that:

* Lack physical dexterity to properly operate the EyeQue device.
* Lack the ability to follow instruction
* Lack a command of the English language
* Lack binocular vision
* Are colorblind
* Had eye surgery within the last 12 months (including Lasik)
Trace Elements Concentration in Dialysis

In hemodialysis population the study team finds high concentrations of toxic trace elements (2 times higher than the general population for cadmium 4 to 13 times for lead). Several recent studies suggest a role of chronic exposure to cadmium in the loss of residual renal function, osteoporosis, graft failure, arteriosclerosis, as well as in excess cardiovascular mortality.

Moreover, in hemodialysis population, a deficit of certain essential trace elements (manganese, selenium, zinc) is observed. For example, in the population undergoing chronic hemodialysis, a zinc deficiency is found in 40 to 78% of cases. Zinc is a cofactor of more than 70 enzymes.

In this observational cohort, the study team seeks to understand the impact of HD and HDF on the serum concentrations of heavy metals and also oligometals, by studying their concentrations in the dialysate during dialysis sessions by inductive coupled plasma mass-spectrometry (ICP-MS).

Primary objective: Evaluate the trace element concentration (heavy metals Cd and Pb and oligometals: Fe, Zn, Cu, Mn and also Se) in the dialysate before and during dialysis session. By studying the variation in concentration between the initial concentration of trace element in the dialysis fluid and the final concentration after membrane in the dialysate (waste pipe).

Method : Prospective study, in dialysis population, inclusion period will be from September 1, 2021 to January 31, 2022, in Ambroise Paré hospital, Paris, France. Duration of follow-up will be 1 day.

Dialysate samples will be taken in the venous injection site before connecting the patient, at 0 and 10 minutes after disinfection.

After connecting the patients, post-membrane dialysis sample (waste pipe) will be taken at 30, 60, 120 and 180minutes. Trace element dosage will be done by ICP-MS.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18;
* End-stage chronic renal failure in chronic dialysis;
* Duration of dialysis session ≥3h;
* Vascular approach: arteriovenous fistula;
* Affiliation to a social security scheme or entitled.

Exclusion Criteria:

* Opposition to participate to the study;
* Daily dialysis;
* Duration of dialysis session \< 3h and \> 8h;
* Vascular approach: venous catheter; Weekly dialysis session ≤3; Patient under french AME health system.
PET/CT-directed Hyperfractionated Radiation Dose Escalation in Stage III Non-small Cell Lung Cancer

The goal of this study is to find the maximum tolerable dose of radiation that can be delivered combined with chemotherapy (carboplatin \& paclitaxel) in patients with stage III non-small cell lung cancer (NSCLC).

Concurrent chemoradiotherapy is the standard of care for unresectable stage III NSCLC based on the results of phase III randomised trials. The current standard radiation therapy dose has remained 60- Gy at -2 Gy/fraction for nearly four decades (60Gy), with local disease control rates of approximately 50% and a median overall survival of only 18 months.These results are suboptimal and more effective treatment regimens are needed.

We hypothesize that hyperfractionated radiation dose escalation to residual tumor volumes after standard chemoradiotherapy as defined by positron emission tomography (PET) /computed tomography (CT) would improve local control and overall survival while reducing the acute and late normal tissue toxicity.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have FDG-avid and histologically or cytologically proven non-small cell lung cancer.
2. Age 1 8-75.
3. Zubrod performance status 0-2.
4. Stage III ( American Joint Committee on Cancer AJCC, 7th ed.).
5. No prior radiation to the thorax that would overlap with the current treatment field.
6. Adequate bone marrow, renal and hepatic functions as assessed by the following: Hemoglobin \>/= 10.0 g/dl, Platelet count \>/= 1 00,000/mm\^3,absolute granulocyte count (AGC) ≥2 × 10\^9 cells/L,bilirubin and Aspartate transaminase ≤1.5 ×upper limit of normal (ULN), Creatinine \</=1 .5 times ULN.
7. A signed informed consent must be obtained prior to therapy.
8. Induction chemotherapy is allowed.
9. Life expectancy more than 3 months.

Exclusion Criteria:

1. Patients with any component of small cell lung carcinoma are excluded from this study.
2. Patients with evidence of a malignant pleural or pericardial effusion are excluded.
3. Prior radiotherapy that would overlap the radiation fields.
4. Uncontrolled concurrent illness including, but not limited to: Chronic Obstructive Pulmonary Disease(COPD) exacerbation or other respiratory illness, serious uncontrolled infection, symptomatic congestive heart failure (CHF),unstable angina pectoris, uncontrolled hypertension,or psychiatric illness/social situations that would limit compliance with the study requirements.
5. Known hypersensitivity to paclitaxel.
6. Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study.
7. Acquired Immune Deficiency Syndrome.
8. Conditions precluding medical follow-up and protocol compliance.
Moxibustion for Knee Osteoarthritis

This study aims to assess the feasibility, effectiveness and safety of moxibustion for symptom management and function improvement in patients with knee osteoarthritis, compared to usual care group.

Knee osteoarthritis (OA) is a common joint disease and a leading cause of pain and physical disability in older people. Its symptoms, including pain and physical disability, significantly affect patient's quality of life, and increased depression has been observed in patients with greater pain due to knee OA. Current management options include exercise, weight reduction, Non-steroidal anti-inflammatory drugs (NSAIDs) and other pain medication, intra-articular injections of steroid or hyaluronan, arthroscopic surgery and joint replacement. Except exercise and weight reduction, no known interventions have shown definitive evidence of benefits and safety for knee OA. Thus, it is still worth exploring effective and safe management options for knee OA patients.

Moxibustion is one of traditional Asian medicine using the heat stimulation by burning mugwort (mainly Artemisia vulgaris or Artemisia argyi) on acupuncture points, and regarded as a subtype of acupuncture. Previous literatures reported its use on chronic conditions including gastrointestinal disease, hypertension, musculoskeletal pain, cancer care, gynecological conditions and stroke rehabilitation solely or in combination with routine care or other traditional medicine. However, studies adequately evaluating effects and safety of moxibustion for patients with knee OA are insufficient. Given the gaps between little evidence for effects and safety of moxibustion for knee osteoarthritis and its wide use in clinical practice, the investigators attempted to assess the feasibility, effectiveness and safety of moxibustion for patients with knee osteoarthritis.

Eligibility Criteria:
Inclusion Criteria:

* Aged from 40 to 70 years old
* Average daily knee pain over 40 points (0-100 point scale)
* diagnosed as knee osteoarthritis according to ACR criteria

Exclusion Criteria:

* Current of past history of inflammatory disease including rheumatoid arthritis
* Cancer
* Traumatic injury which might be related to current knee pain
* Autoimmune disease
* significant deformity of knee joints
* knee replacement surgery on affected knee
* knee arthroscopy within 2 years
* steroid injection in knee joints within 3 months
* viscosupplement injections in knee joints within 6 months
* joint fluid injection within 6 months
* received acupuncture, moxibustion, cupping or herbal medicine within 4 weeks
* uncontrolled hypertension
* diabetes mellitus requiring insulin injection
* life-threatening cardiovascular or neurological events within one year
* chronic respiratory disease
* hemorrhagic disorder
* alcohol or drug addition
* active infectious disease including tuberculosis
* keloidosis
Efficacy and Safety of Rapamycin Versus Vigabatrin in the Prevention of Tuberous Sclerosis Complex Symptoms in Infants

The purpose of the study is to evaluate the efficacy, tolerability, and safety of vigabatrin versus rapamycin as a preventive treatment in infants with Tuberous Sclerosis Complex (TSC).

This is a two-arm, randomized, double-blind and double-dummy, placebo controlled study to evaluate the efficacy, tolerability, and safety of vigabatrin versus rapamycin as a preventive treatment in infants with TSC. The study consists of 3 phases for each patient: screening, core blinded phase, and open-label follow-up phase. Patients who meet the eligibility criteria will be randomized to receive vigabatrin or rapamycin. The randomization ratio is 1:1. Randomization will be stratified by the sex and the presence of epileptiform activity on baseline videoEEG (video electroencephalography) recording (yes versus no). Approximately 60 infants are planned to be enrolled in the study.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged from 4 up to 16 weeks (44-56 weeks of gestational age) at the day of randomization
* Parents/caregivers are willing to and able to give informed consent form for the participation in the study
* Parents/caregivers are willing to and able to comply with all study requirements
* Definite diagnosis of TSC according to the Consensus criteria (Northrup,2013)
* At least 1 focus of cortical dysplasia disclosed on brain MRI

Exclusion Criteria:

* history of seizures prior to randomization,
* history of antiepileptic treatment,
* history of treatment with mTOR (mammalian Target of Rapamycin) inhibitor,
* gestational age below 44 weeks at the day of randomization,
* body weight lower than 3 kg at the day of randomization,
* SEGA (Subependymal Giant Cell Astrocytoma) or other TSC-associated lesion requiring urgent surgical intervention
* recent surgery within 1 month prior to the randomization
* intercurrent infection at the date of randomization
* known history of HIV seropositivity
* live vaccination within 1 month prior to randomization\*
* lack of first TBC and hepatitis B vaccinations
* Any significant clinical, laboratory , ECG or other abnormalities, comorbidity or concomitant treatment which, in the opinion of the investigator, may either put a patient at significant risk associated with the participation in the study or may influence the results of the study.
* Use of an investigational drug within 1 month prior to randomization.
Effect of Preoperative Oral Carbohydrates on Postoperative Insulin Resistance in Patients Undergoing OPCAB(Off- Pump Coronary Artery Bypass Surgery)

Surgical stress creates a state of insulin resistance which has been related to increased postoperative complications. Fasting before surgery induces a catabolic state that contributes to the development of insulin resistance. The aim of this study is to evaluate the effect of preoperative oral carbohydrates on postoperative insulin resistance in patients undergoing OPCAB (off-pump coronary artery bypass surgery). Sixty patients, aged 20 to 79 years, scheduled for OPCAB will be divided into carbohydrate (n=30) and control (n=30) groups. Randomly selected patients of the carbohydrate group are given 400ml of 12.8 g/100 ml carbohydrate beverage in the evening before surgery and in the morning of the operation day (3 hours before their scheduled operation). In contrast, patients in the control group consume no food or drink after midnight before their surgery. The primary endpoints are postoperative insulin resistance measured by short insulin tolerance test.


Eligibility Criteria:
Inclusion Criteria:

* patients who are scheduled to undergo OPCAB

Exclusion Criteria:

* Subjects are ineligible if they have DM(Diabetes Mellitus),
* Gastroesophageal reflux disease or gastric emptying disorder,
* inflammatory bowel disease,
* previous treatment for intra-abdominal cancer,
* entered surgery more than 5 hours after ingestion of the morning carbohydrate beverage,
* cognitive dysfunction,
* disabling mental change disorder,
* are unable to communicate or speak Korean
Pharmacokinetic Study of AR882 in Subjects With Various Degrees of Renal Impairment

This is a 2-segment, multi-center, phase 1, open-label, study evaluating the pharmacokinetics and pharmacodynamics of AR882 in subjects with various degrees of renal impairment.


Eligibility Criteria:
Inclusion Criteria:

All Subjects:

* Males and non-pregnant, non-lactating females
* Body weight no less than 50 kg
* sUA greater than or equal to 4.0 mg/dL

Renal Impaired Subjects:

• History of chronic renal impairment (\> 6 months)

Exclusion Criteria:

All Subjects:

* Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
* History of cardiac abnormalities
* Active peptic ulcer disease or active liver disease
* History of kidney stones

Renal Impaired Subjects:

• Requires dialysis
Predicting the Efficacy and Prognosis of Rectal Cancer Patients Based on ctDNA-MRD Technology

The purpose of this study is to study the performance of MRD monitoring in predicting the efficacy and prognosis of neoadjuvant therapy in patients with rectal cancer, and to explore the value of MRD detection in evaluating the prognosis of patients. In this prospective study, 50 patients with stage II-III rectal cancer who are planing to receive neoadjuvant chemoradiotherapy will be enrolled. The tumor tissue will be collected by colonoscopy before treatment and blood samples will be collected before treatment and during treatment.The whole blood samples will receive MRD detection. The change rate and clearance rate of MRD during treatment will be calculated, and will be associated with imaging efficacy evaluation, pathological efficacy evaluation,and prognosis, to determine the performance of MRD in predicting and judging the efficacy of neoadjuvant chemoradiotherapy and postoperative recurrence of rectal cancer.

This study is a prospective, observational study. It is expected to enroll 50 patients with newly diagnosed stage II-III rectal cancer.Before neoadjuvant chemoradiotherapy, tumor tissue will be collected by colonoscopy biopsy for WES and customized panel design, and peripheral blood samples will be collected for baseline MRD detection ( MRD1 ) and during neoadjuvant concurrent chemoradiotherapy ( MRD2-6 ) .Peripheral blood sample will be collected 3-4 weeks after radical surgery ( MRD7 ). For patients who achieved cCR after the end of neoadjuvant therapy and adopted the W \& W ( watch and wait ) strategy, the sampling time point was 3 months after the start of watching and waiting ( MRD7 ).

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75
2. Rectal adenocarcinoma confirmed by pathology
3. The clinical stage is II-III.
4. Neoadjuvant chemoradiotherapy + radical surgery is planned ( cCR patients can choose to wait for observation ).
5. ECOG 0-1;
6. No distant metastasis ;
7. Main organ function is normal ;
8. signed informed consent and willing to accept long-term follow-up；
9. No anti-tumor treatment was received within 4 weeks before baseline sampling ;
10. Adequate ' colonoscopy ' tumor tissue samples can be provided for MRD customization, and sufficient whole blood samples need to be provided for baseline MRD detection.

    -

Exclusion Criteria:

1. unable to provide sufficient tissue / blood samples to meet the research needs ;
2. received radiotherapy, chemotherapy, or other targeted or immunotherapy before enrollment ;
3. Patients did not receive neoadjuvant therapy according to the original plan ;
4. Patients refused to accept genetic testing. -
Red Blood Cell Distribution Width as a Marker of Contrast Induced Nephropathy in Patients With Coronary Intervention

Contrast Induced Nephropathy is an acute renal insufficiency defined as a 25% or 0.5 mg/dl increase over the baseline of the serum creatinine level 24 h to 72 h after intravascular administration of a contrast agent.

Contrast Induced Nephropathy has been introduced an important complication after coronary angiography and Percutaneous Coronary Intervention .

The development of Contrast Induced Nephropathy after Percutaneous Coronary Intervention is associated with poor clinical outcomes including prolonged hospitalization, increased costs, increased rates of end-stage renal failure, myocardial infarction, repeat revascularization, and short- and long-term mortality.

Contrast Induced Nephropathy follows decreased renal perfusion and administration of nephrotoxic medications as the third most common cause of renal insufficiency during hospitalization.

Patients with acute coronary syndrome have a 3-fold higher risk of developing Contrast Induced Nephropathy .Therefore ,predicting contrast nephropathy and initiating therapeutic preventive strategies are very important.

Red Blood Cell Distribution Width is a quantitive marker of the variability on size of erythrocyte.

It is a routine assay of Complete Blood Count that doesn't require an additional cost, that is calculated by dividing the standard deviation of the mean cell size by the Mean Corpuscular Volume of the red cells and multiplying by 100 to convert to a percentage.

Normal range of Red Blood Cell Distribution Width 11-16%. Increased Red Blood Cell Distribution Width means increased variability in red blood cell size owing to ineffective erythrocyte production, which is associated with indices of inflammation and pro-inflammatory cytokines such as interleukin-6 .

On the other hand, suggested mechanisms underlying Contrast Induced Nephropathy include cytotoxic effects, factors that affect renal hemodynamic, and regional hypoxia.

Eligibility Criteria:
Inclusion Criteria:

Consecutive patients who underwent percutaneous coronary intervention either elective or emergency.

Exclusion Criteria:

1. End stage renal disease with glomerular filtration rate less than 30 ml/1.73.
2. Patient known allergy to contrast agents.
3. Left ventricular ejection fraction below 30%.
4. Presence of infection
5. A recent history of contrast administration in the previous month.
6. Patient known to have thyroid disease.
7. History of malignancy.
8. Patient known to have Autoimmune disease.
9. Decompensated liver cirrhosis
10. Cardiogenic shock.
11. Anemia
Effect of Avocado Honey (Apis Mellifera) on Anthropometric and Biochemical Parameters in Healthy Subjects: A Pilot Study

Thirteen healthy subjects (5 males; 8 females) ages 25-50 years, with BMI (body mass index): \<25 kg/m2 completed the study. The participants were selected randomly, either the control group (n= 7) or honey group (n= 6). Subjects of honey group consumed 25 g of honey each day for 4 weeks.

18 healthy participants (body mass index \[BMI\] \<25 kg/m2) between 25-50 years of age were recruited, of which 13 subjects (male \[n=5\]) and female \[n=8\]) completed the study. The participants were allocated randomly either control group (n= 7) or honey group (n= 6). Subjects of honey group consumed 25 g of honey each day for 4 weeks. Participants of both groups did not undergo a special diet regimen, drug therapy, or change in their lifestyle, such as physical exercise, during the period of study. A 3- day food record including two weekdays and one weekend day was used to assess the habitual food intake of the participants prior to initiation of the trial and repeated each week of intervention. Also, dietary intake was calculated using the database Food Processor® (Version. 10.3.0.), including nutritional information of Mexican foods when they weren't on the list.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Female
* Ages 25-50 years,
* BMI (body mass index): under 25 kg per m2.

Exclusion Criteria:

* Not smoker
* Not have an allergy to honey
* Not pregnant,
* Not been previously diagnosed any disease resulting in metabolic disorders
* Not chronically use medications known to affect metabolism
* Not participate in greater than 3 hours of structured exercise per week.
* Female participants that used some kind of contraceptives
Seroprevalence Study of Hepatitis A, Varicella-Zoster, Cytomegalovirus, Herpes Simplex and Bordetella Pertussis

The purpose of this study is to determine the seroprevalence of Hepatitis A Virus (HAV), Varicella-Zoster virus (VZV), Cytomegalovirus (CMV), Herpes Simplex (HSV) and Bordetella pertussis (BP)infections in Mexico.

In order to document the epidemiological changes in the sero-prevalence of Hepatitis A, Human simplex virus (1 and 2), Varicella-Zoster virus and Cytomegalovirus infections, we propose to conduct a population based, seroprevalence, cross-sectional study, in Mexico. This will allow the identification of susceptible populations, which in turn, will serve as evidence for the elaboration of recommendations for the prevention of Hepatitis A, Human simplex virus, Varicella-Zoster virus and Cytomegalovirus infection in the region.

This study was conducted using data and serum samples from a random sample of subjects that participated in the 2006 National Health and Nutrition Survey.

Eligibility Criteria:
Inclusion Criteria:

• Previously enrolled subjects aged \>= 1 to 70 years for National Health and Nutrition Survey 2006 in Mexico, with previously obtained informed consent

Exclusion Criteria:

* Information required for the study is not available or incomplete.
* Inadequate or insufficient serum sample to detect viral agents required for the study.
* Serum sample wrongly identified.