cyrilzakka/clinical-trials huggingface dataset:
Assessing Diabetes Mellitus on Cytokine Analysis and Macular Edema Following FLACS

The purpose of this study is to assess the effects of diabetes mellitus (DM) on anterior chamber cytokine production and postoperative macular edema in patients undergoing femtosecond laser-assisted cataract surgery (FLACS). Patients with DM routinely undergo FLACS, yet the majority of studies evaluating intraocular inflammation following femtosecond laser treatment have excluded this patient population. Importantly, DM alters the inflammatory status of the eye, which may influence the production of inflammatory mediators following femtosecond laser treatment and the development of postoperative macular edema. The results from this study will provide insight into the risks and benefits of FLACS in patients with DM.

As discussed above.

Eligibility Criteria:
Inclusion Criteria:

* All patients who are scheduled for manual cataract surgery or FLACS who have provided informed consent, in accordance with application regulations and guidelines.
* Only one eye from each participant will be included in the study (the first one to be operated on).

Exclusion Criteria:

* Intravitreal anti-VEGF injection \< 3 months prior to cataract surgery
* Laser photocoagulation \< 3 months prior to cataract surgery
* Complications during manual cataract surgery or FLACS
* Current or previous ocular or systemic inflammation
* History of rheumatic or immune disease
* Poor pharmacologic mydriasis
* Corneal opacities
* Pseudoexfoliation syndrome
* Previous ocular surgery or trauma
* Use of topical or systemic steroids \< 6 months prior to surgery
* Prostaglandin analog eyedrop therapy
* Glaucoma
* Age-related macular degeneration
The Effects of Corneal Collagen Cross-linking

The corneal collagen cross-linking treatment has been used with increasing success to treat corneal dystrophies such as "keratoconus." Recent advances have allowed different techniques for performing this cross-linking treatment. This study investigates the effects of corneal cross-linking using different surgical techniques.


Eligibility Criteria:
Inclusion Criteria:

* Age 10-70, willing to participate, diagnosis of corneal ectasia disorder

Exclusion Criteria:

* Unwilling or unable to participate in trial
Cocktail Injection Improves Outcomes of FFR Guided PCI

This is a randomized, single blind, controlled study of intracoronary cocktail injection before fractional flow reserve (FFR) measurement when guiding percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS).

This is a randomized, single blind, controlled study of intracoronary cocktail injection before fractional flow reserve (FFR) measurement when guiding percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS). Patients with ACS will be randomized into the cocktail plus FFR guided group or the QCA guided group. The primary outcome of the cocktail II study is the composite of death, myocardial infarction, class IV heart failure and target vessel revascularization within 1 year. The secondary outcome of the cocktail II study include left ventricular function, quality of life, stroke or life-threatening bleeding within 1 year.

Eligibility Criteria:
Inclusion Criteria:

* patients with a clinical diagnosis of recent ACS within 5 days

Exclusion Criteria:

* haemodynamic instability
* intolerance to anti-platelet drugs
* ineligible for coronary revascularization
* a treatment plan for non-coronary heart surgery (e.g. valve surgery)
* a history of prior PCI or CABG
* angiographic evidence of severe (e.g. diffuse calcification) or mild (\<30% severity) coronary disease
* a life expectancy less than 1 year
* adenosine allergy
HYDROchlorothiazide to PROTECT Polycystic Kidney Disease Patients and Improve Their Quality of Life

Autosomal dominant polycystic kidney disease (ADPKD) is characterized by progressive formation of renal cysts which ultimately lead to a loss of renal function.

Tolvaptan (a V2R antagonist) is currently the only effective treatment for preserving renal function in ADPKD. However, side-effects such as polyuria limit its tolerability and thereby the therapeutic potential. This study will test whether co-administration with hydochlorothiazide can improve V2RA efficacy (slowing kidney function decline) and tolerability (quality of life) in ADPKD. Approximately 300 patients will be enrolled.

Aims: The main objectives of the current study are to prospectively test whether HCT co-treatment can improve V2RA efficacy (slowing kidney function decline) and tolerability (quality of life) in PKD.

Study design: Investigator driven randomized placebo-controlled multicenter trial

Study population: 300 ADPKD patients of ≥18 years, with an eGFR of \> 25 mL/min/1.73m2, on stable treatment with the highest tolerated dose of V2RA

Intervention: Oral HCT 25 mg once daily or matching placebo for a total of 156 weeks. The randomization ratio will be 1:1.

Study visit schedule: study measurements will be performed during 12-weekly visits (which is routine care for V2RA treated patients), except for one additional study visit (or telephone call) 2 weeks after the start of treatment

Primary study outcome: Slope of kidney function decline (measured by eGFR)

Eligibility Criteria:
Inclusion Criteria:

* ADPKD diagnosis (modified Ravine criteria)
* ≥18 years old
* eGFR \> 25 mL/min/1.73m2
* On stable treatment with the highest tolerated dose of V2RA for a minimum of 3 months

Exclusion Criteria:

* Known intolerance to hydrochlorothiazide
* Use of any diuretic
* Orthostatic hypotension complaints or blood pressure \<105/65mmHg during screening visit
* Uncontrolled hypertension (blood pressure \>160/100mmHg)
* Hypokalemia (\<3.5 mmol/L)
* History of active gout on maintenance preventive treatment for gout (allopurinol, desuric and/or colchicine), defined as ≥2 episodes during the last year
* History of skin cancer (basal cell, squamous cell and melanoma)
Central Blood Volume in Hypotensive Dialysis Patients

The purpose of the study is to test whether hypotensive episodes during dialysis - caused by withdrawal of fluid drom the circulation - can be predicted by means of two harmless monitoring techniques.


Eligibility Criteria:
Inclusion Criteria:

* Chronic hemodialysis patients with central vascular access

Exclusion Criteria:

* Patients below 18 years of age
* Patients unable to give informed consent
A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors

This is a Phase 1a/1b, dose-escalation/expansion, consecutive-cohort, open-label study to evaluate the safety, tolerability, PK, PD, and preliminary evidence of antitumor activity of PLN-101095 in combination with pembrolizumab (the study treatment regimen) in adult participants with advanced or metastatic solid tumors for which pembrolizumab is indicated but have documented disease progression (refractory \[primary resistance\]) or relapsed \[secondary resistance\]) after at least 3 months from the start of treatment with pembrolizumab.

The study will consist of 2 main parts:

* Part 1: Consecutive dose-escalation cohorts using a Bayesian optimal interval (BOIN) dose escalation design
* Part 2: Dose-expansion cohorts using Simon's 2-stage design


Eligibility Criteria:
Inclusion Criteria:

1. Has histologically or cytologically confirmed advanced solid tumor
2. Has an advanced or metastatic solid tumor (for which pembrolizumab is indicated) and have evidence of disease progression after treatment with pembrolizumab.
3. At least 1 measurable lesion, as defined by RECIST v1.1
4. Estimated survival of ≥3 months
5. No effective therapeutic options available (eg, has received standard of care or is intolerant of, refuses, or is not eligible for standard of care antineoplastic therapy)

Exclusion Criteria:

1. Any immune-related medical conditions that would put participants at greater risk when receiving pembrolizumab
2. Previous treatment with pembrolizumab \<21 days prior to the first dose of combination therapy of pembrolizumab and PLN-101095
3. Received an immunotherapy other than pembrolizumab in the last 4 weeks prior to the first dose of PLN-101095
4. Received radiotherapy (RT) within 1 week for palliative bone-directed therapy and 4 weeks for all other types, prior to the first dose of PLN-101095
5. Received chemotherapy or other targeted therapies within 2 weeks prior to the first dose of PLN-101095
6. Received a cell therapy within the last 12 months prior to the first dose of PLN-101095
7. Known active central nervous system (CNS) metastases (brain and/or leptomeningeal metastases)
8. Pregnant or lactating female participant
Ahmed Glaucoma Valve and Single-Plate Molteno Implants in Treatment of Refractory Glaucoma

The purpose of this study is to investigate the efficacy and safety of the Ahmed valve implant (AVI) and the Molteno single-plate implant (MSPI) in eyes with refractory glaucoma during a follow-up period of 24 months.


Eligibility Criteria:
Inclusion Criteria:

* refractory glaucoma, defined as uncontrolled IOP despite maximal anti-glaucoma medication, previously failed nonseton surgical treatment, or a combination thereof.

Exclusion Criteria:

* age less than 40 years
* a visual acuity of no light perception
* lens opacity
* elevated IOP associated with silicone oil previous glaucoma drainage device implantation in the same eye
* previous cyclodestructive treatment
* increased risk of endophthalmitis posterior segment disorders
* pre-existing ocular comorbidities.
Magnetic Stimulation as a Treatment for Stress Urinary Incontinence

The goal of this clinical trial is to determine the efficacy of electromagnetic stimulation treatment of the pelvic floor muscles in adult females with stress urinary incontinence.

A double-blinded randomized controlled clinical trial with a treatment arm and a sham treatment arm will be conducted; followed by an open label trial at 3 months for any sham treatment arm participants who do not meet treatment success.

The primary goal is to compare the subjective success rates for the resolution of stress urinary incontinence (SUI) for the magnetic stimulation treatment at 3 months. Secondary aims include an assessment of complications, resolution of SUI symptoms, patient bother from UI, quality of life and patient satisfaction. The proposed sample size is 158 patients. At the 3-month post treatment evaluation, the treatment allocation will be unmasked. Patients will be followed post treatment up to 2 years.

Eligibility Criteria:
Inclusion Criteria:

1) Non-pregnant adult female, not planning pregnancy during the duration of the study 2) Stress urinary incontinence (SUI), as confirmed by history, focused evaluation for ≥3 months 3) objective proof of SUI: Observation of urine leakage by cough and valsalva (positive stress test) at a bladder volume of ≤ 300cc 4) Bladder capacity ≥200cc 5) Post void residual ≤100cc with Stage I or lower pelvic organ prolapse 6) No concurrent or new planned treatment for SUI during the treatment period and the 3 months following it 7) No known body metal from umbilicus to knees 8) Willing and able to comply with the protocol.

Exclusion Criteria:

1) Patient is pregnant, lactating, or plans to become pregnant during the Study; or Patient is \<12 months post partum 2) Patient has other predominant type of UI (e.g. Urgency UI, overflow UI, fistula) 3) Current chemo/radiotherapy; history of pelvic radiation; or pelvic surgery \< 3 months 4) Systemic diseases known to affect bladder function (e.g. Parkinson's disease, multiple sclerosis, spina bifida, spinal cord injury) 5) Current or history of urethral diverticulum, prior augmentation cystoplasty, implanted nerve stimulators for bladder symptoms 6) Current evaluation or treatment for chronic pelvic pain 7) Participation in another treatment intervention that might interfere with the results of this trial 8) Patient has a medical condition or disorder that may cause non-compliance with the protocol (e.g. unable to perform self-evaluations and/or accurately report medical history, and/or data). 9) Patient has ambulatory 24-hour pad test, where the increased pad weight is \< 3 grams. 10) Patient is non-ambulatory (ambulatory with assistive devices allowed) or unable to sit in a chair independently 12) Known body metal located from umbilicus to knees, or cardiac pacemaker 13) Previous magnetic stimulation therapy
Yoga to Prevent Mobility Limitations in Older Adults

The loss of mobility during aging impacts independence and leads to further disability, morbidity, and reduced life expectancy. The study objective was to examine the feasibility and safety of conducting a randomized controlled trial of yoga for older adults at risk for mobility limitations. The investigators hypothesized that sedentary older adults could be recruited for the study, would attend either yoga or a health education control, would complete assessments, and that the interventions could be safely delivered.


Eligibility Criteria:
Inclusion Criteria:

* age 60-89 years
* self-reported sedentary lifestyle (not exercising in the past 3 months; included walking at a brisk pace or regular walking for exercise purposes)
* SPPB summary score \> 3 and ≤ 8
* willingness attend either yoga or health education for 10 weeks
* willing to complete two assessments
* residence in San Diego metropolitan area
* provided a physician-signed health clearance form.

Exclusion Criteria:

* practiced yoga \> 2x in the last year
* life expectancy \< 12 months.
Study of ZGGS18 in Patients With Advanced Solid Tumors

A clinical study to assess dose escalation, tolerance, safety, pharmacokinetics, and multi cohort expansion of ZGGS18 in patients with advanced solid tumors


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of advanced solid tumors, who had failed the available standard treatments or no standard treatment or intolerance to standard treatment;
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
* Life expectancy ≥ 3 months;
* Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors 1.1(RECIST1.1). For lesions that have received radiation therapy, only after the progression of the lesions, they can be considered measurable lesions.

Exclusion Criteria:

* The investigator considers that any subjects are not suitable to participate in the trial.
Study on B-blockers to Prevent Decompensation of Cirrhosis With HTPortal

This is a multicenter, randomized, double-blind, placebo-controlled study on the effectiveness of treatment with beta-blockers to prevent decompensation of cirrhosis with portal hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 80 years old.
* With liver cirrhosis diagnosed by previous biopsy or by clinical criteria, and analytical image.
* No esophageal varices (or with small varices without red signs) in a recent videogastroscophy (\<3 months before randomization).
* Absence of ascites demonstrated by a recent ultrasound (\<3 months before the randomization).
* informed consent

Exclusion Criteria:

* previous decompensation of liver cirrhosis associated with portal hypertension.
* GPVH \<10 mmHg.
* Portal axis thrombosis affecting the portal trunk or main hepatic branches, or the splenic or mesenteric vein.
* Hepatocellular carcinoma demonstrated by two imaging tests.
* Bilirubin\> 3 mg / dl (or\> 50 micromol / l), platelets \<30 x10E9/lo Quick \<30%.
* Presence of renal insufficiency (serum creatinine\> 2 mg / dl or\> 200 micromol / l).
* Any comorbidity involving a therapeutic limitation and / or a prognosis of life \<12 months.
* Absolute contraindication to treatment with β-blockers (severe bronchospasm, stenosis aortic A-V block, intermittent claudication, severe psychosis, bronchial asthma)
* Hypersensitivity to β-blockers.
* Pregnancy or lactation.
* To receive anticoagulant treatment.
* Past treatment with nitrated or β-blockers in the two weeks prior inclusion.
* Cirrhosis C virus active antiviral therapy.
An Extension Study of an Investigational Drug, Lumasiran (ALN-GO1), in Participants With Primary Hyperoxaluria Type 1

The purpose of this study is to evaluate the long-term safety and tolerability of lumasiran in participants with Primary Hyperoxaluria Type 1.


Eligibility Criteria:
Inclusion Criteria:

* Enrollment within 12 months of completion of Study ALN-GO1-001
* In the opinion of the investigator tolerated the study drug
* If taking Vitamin B6 (pyridoxine), willing to remain on a stable regimen for the study duration
* Women of child-bearing potential must have a negative pregnancy test, cannot be breast feeding, and must be willing to use a highly effective method of contraception
* Willing to provide written informed consent and to comply with study requirements

Exclusion Criteria:

* Clinically significant health concerns (with the exception of PH1)
* Clinically significant cardiovascular abnormality
* Abnormal for AST/ALT and any other clinical safety laboratory result considered clinically significant
* Requirement for chronic dialysis
Essential Amino Acids Supplementation and Muscle Protein Synthesis

The modern warfighter faces numerous physiological challenges including sleep deprivation, sustained intense physical activity, and caloric restriction, the combined effects of which may result in the loss of lean body mass and decreased physical performance. Dietary interventions may help preserve lean body mass and facilitate recovery from periods of intense physical demand. For example, dietary strategies that increase amino acid availability have been shown to stimulate protein synthesis in skeletal muscle following resistance exercise. Because military tasks also incorporate endurance exercise components, studies regarding the effects of increasing dietary amino acids following endurance exercise are warranted. The objectives of this study are to characterize the effect of endurance exercise on protein synthesis and breakdown as well as the ability of an essential amino acid supplement to influence skeletal muscle protein metabolism and its cellular and molecular regulation following endurance exercise.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 - 35 years
* Weight stable
* Recreationally active with VO2max of 40 - 50 ml/kg/min
* Refrain from taking any NSAIDS or any aspirin-containing medications
* Supervisor approval if a federal employee

Exclusion Criteria:

* Disease or medication that affects macronutrient metabolism and/or the ability to participate in strenuous exercise
* Allergies to foods or medications (including, but not limited to, lidocaine or phenylalanine) to be utilized in the study
* Abnormal PT/PTT test or problems with blood clotting
* Present condition of alcoholism or other substance abuse that compromises exercise capacity
* Musculoskeletal injuries that compromise the ability to exercise
* Pregnancy
Pharmacokinetics (PK) of Ertapenem Intravenous (IV) Bolus Versus Standard Infusion

The purpose of this study is to characterize and compare the concentration-time profiles and multiple dose pharmacokinetics of a 5 minute intravenous (IV) bolus of ertapenem 1 gram daily versus the standard 30 minute infusion in healthy volunteers. Safety and tolerability and pharmacodynamic target attainment using Monte Carlo simulation will also be assessed and compared.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults (18 years of age or older)

Exclusion Criteria:

* Ertapenem or other beta-lactam allergy
* Pregnant or breast feeding females
* Body Mass Index (BMI) greater than or equal to 30
* Abnormal lab values at baseline
* Hypertension
* Significant medical abnormality
* Regular alcohol consumption
* Significant nicotine use
A Study Evaluating the Safety and Efficacy of AVE5530 (4 Weeks) in Patients With Mild to Moderate Hypercholesterolemia

The primary objective of this study is to assess the effect of AVE5530 on LDL-C levels over a period of 4 weeks. The secondary objectives are to assess the effects of AVE5530 on other lipid plasma levels and the safety and tolerability of AVE5530.


Eligibility Criteria:
Inclusion Criteria:

* Patients with mild to moderate primary hypercholesterolemia with stabilized LDL-C baseline ≥130 mg/dL and ≤ 250 mg/dL (≥ 3.36 mmol/L and ≤ 6.46 mmol/L)
* Male aged ≥ 18 years or postmenopausal women at screening

Exclusion Criteria:

* Presence of any clinically significant endocrine disease known to influence serum lipids or lipoproteins
* Patients with type 1 diabetes
* Presence or history of cancer within the past five years
* Triglycerides ≥ 300 mg/dL (3.39 mmol/L)
* Fasting plasma glucose \> 160 mg/dL (8.9 mmol/L)
* Impaired kidney function and active liver disease
* Within one month prior to screening visit and/or at the time or after the screening visit, administration of any lipid lowering treatment
* Creatine Kinase \> 2xUpper Limit of Normal range

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Investigating the Needs of Childhood Cancer Survivors: The Unreported Experience

This feasibility study will determine the psychometric adequacy of a newly developed instrument - Childhood Cancer Survivor Study Needs Assessment Questionnaire (CCSS-NAQ). Additionally, the study will explore the feasibility of selected study methods -- sample selection, length of time to complete recruitment, and response rates - in order to inform a larger national periodic survey of adult survivors' health related needs

This study will focus on the following primary and secondary objectives:

1. Examine the construct validity, short-term stability, internal consistency and item-response performance of a health-related needs assessment self-report instrument for adult childhood cancer survivors
2. Inform future sample stratification by over-sampling minority and rural-dwelling survivors to enhance the heterogeneity of the respondent pool;
3. Describe the met and unmet health-related needs and their covariates in a large, stratified, random sample of childhood cancer survivors;
4. Evaluate the sample selection methods, length of time to complete recruitment, and response rates in the study sample.

Eligibility Criteria:
Inclusion Criteria:

1. Living CCSS participant
2. Age 25 years or older on December 31, 2009
3. History of successful independent (non-surrogate) response to previous CCSS surveys (Flesch-Kincaid reading level for non-medical items established at 4th-6th grade).

Exclusion Criteria:

Received treatment for pediatric malignancy at St. Jude Children's Research Hospital.
The Function of Nutrition Rich Vegan Drink on Inflammatory Bowel Disease

The aim of this project, would be to develop a new formula, with high nutrition content on a vegan basis. The investigators expect to produce this novel vegan-based juice product, which does not exist on the marked today. The juice would consist of different selected varieties of vegetables and fruits. Beside the vegetables, the juice will also contain plant oils to increase the calorie level, as well as a protein sources containing amino acids with high anabolic effects.

The products will be tested in an intervention study on patients with inflammatory bowel disease.


Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 85 years old
* Diagnosed with or show signs of UC or Crohns disease
* Mild symptoms i.e intestinal symptoms
* Has had the same medicin the previous week before starting in the study

Exclusion Criteria:

* Food or vegetable allergi
* Cognitive diseases e.g alzheimers or dementia
* Has diabetes requiring insulin or GLP-1 analog treatment (NB: No does include T2D patients, taking tablets or other diabetes therapy)