cyrilzakka/clinical-trials huggingface dataset:
Therapeutic Ultrasound on Renal Function

This study evaluates whether therapeutic ultrasound (TUS) treatment applied to lumbar region with chronic low back pain affect renal function.

Low back pain is a common problem and there are many treatments for chronic low back pain, including TUS. Investigators routinely observed increased blood creatinine and urea levels in some of patients who received TUS.

Half of patients will receive TUS treatment for low back pain while the other half will not receive. The patients will be evaluated at baseline and the end of the treatment . The serum creatinine, serum cystatin C, 24-hour urine creatinine, creatinine clearance, 24-hour urine microalbumin and microprotein, urine volume, and GFR will be measured at each evaluation.

Eligibility Criteria:
Inclusion Criteria:

* patients aged between 18 and 65 years
* with chronic mechanical low back pain for at least 3 months
* with glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m2, as calculated using the Modification of Diet in Renal Disease formula .

Exclusion Criteria:

* history of lumbar surgery
* having inflammatory low back pain
* having pregnancy
* having active infection
* history of malignancy
* having coagulation disorder
* having a cardiac pacemaker
* having heart failure
* having uncontrolled hypertension or hypotension
* having active psychiatric disease
* presence of skin diseases on low back pain
* taking medicines for low back pain during the physical therapy treatment (except for paracetamol)
* taking a new drug for another disease or undergoing a dose change for a drug taken during the course of physiotherapy.
Efficacy of Selective Laser Trabeculoplasty in Pseudophakic Patients

Retrospective analysis of efficacy of selective laser trabeculoplasty in pseudophakic patients compared to phakic patients is performed.

Inclusion criterion are patients with glaucoma or ocular hypertension who underwent treatment with selective laser trabeculoplasty due to insufficient control of intraocular pressure during their routine treatment at the University Hospital Zurich / Division of Ophthalmology.


Eligibility Criteria:
Inclusion criteria:

* Patients with glaucoma or ocular hypertension who underwent selective laser trabeculoplasty.

Exclusion criteria:

* Optic neuropathy other than glaucoma
Effect of Oxygen Breathing on Flicker Induced Blood Flow Changes in the Optic Nerve Head

Background It has recently been shown that diffuse luminance flicker increases retinal and optic nerve head blood flow. This indicates that a neuro-vascular coupling between neural activity and blood flow exists as described previously for the brain. Although a lot of mediators such as NO, pO2, pCO2, H+ and K+ have been proposed, the mechanism of this coupling is still a matter of controversy. However, it has been shown in an animal experiment, that an increase in blood flow, evoked by diffuse luminance flicker stimulation is paralleled by an decrease in pO2 in the tissue. Thus, in this study we set out to investigate the flicker light induced increase in blood flow under elevated blood pO2.

Study rationale The motive for the investigation of retinal blood flow regulation is to enhance our understanding of the coupling mechanism between increased neural activity and blood flow in the retina in order to gain new insight in the pathophysiology of several eye diseases associated with ocular vascular disorders Study objectives To test the hypothesis whether oxygen breathing influences flicker light induced changes in optic nerve head blood flow


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Blood donation during the previous 3 weeks
Hepatic Enzymes, Psychological Measures, and Sexual Dysfunction Responses to Aerobic Exercise in Hepatitis-C Men

Chronic hepatitis C virus (HCV) infection is a systematic disease that affects several aspects of patients' well-being, including physical, mental, social, and sexual quality of life. In recent years, this clinical trial aims to search the Response of Hepatic Enzymes, Psychological Measures, and Sexual Dysfunction to Aerobic Exercise in Hepatitis Men With Sexual Dysfunction Complaint

Hepatitis Men With Sexual Dysfunction (erectile dysfunction) Complaint (n=46) will be randomized randomly to 23-men exercise-training (one hour walking on treadmill, for 3 months, three walking sessions per the week) hepatitis-C group or 23-men waiting-hepatitis-C group.

Eligibility Criteria:
Inclusion Criteria:

* men with hepatitis C men diagnosis
* men with sexual dysfunction (erectile dysfunction)

Exclusion Criteria:

* obesity , men with cardiac/thoracic/systemic diseases, drugs for sexual dysfunction (erectile dysfunction)
Impact of New Biomarkers on Maintenance of Sinus Rhythm After Cardioversion or Ablation of Atrial Fibrillation

The Biorhythm study aims to investigate the utility of new biomarkers (e.g. MR proANP, ST2) measured pre-procedure for the prediction of procedural success in patients with atrial fibrillation undergoing cardioversion or ablation.

This is a prospective, observational, multicentre study of patients with paroxystic or persistent atrial fibrillation scheduled to undergo cardioversion or ablation of AF in routine practice. Serum levels of MR proANP and ST2 pre-procedure will be measured to attempt to identify a threshold that carries prognostic value for procedural success (maintenance of sinus rhythm at one year).

Eligibility Criteria:
Inclusion Criteria:

* Patients with paroxystic or persistent atrial fibrillation for whom a decision to perform ablation is made.
* Patients with persistent atrial fibrillation for whom a decision to perform cardioversion is made.
* Patients with social security coverage, or beneficiary thereof.
* Patients who provide written informed consent.

Exclusion Criteria:

* Age \<18 years or \>80 years
* Patients with significant valvular heart disease defined as symptomatic aortic valve disease, severe aortic or mitral stenosis or tricuspid or mitral insufficiency grade 3/4 or 4/4
* Patients with pulmonary arterial hypertension \>45 mmHg on echocardiography
* Patients with chronic respiratory disease, chronic obstructive pulmonary disease stage II, III or IV.
* Patients with a left ventricular ejection fraction \<45%
* Patients with recent (\<1 month) acute decompensation of heart failure
* Patients with recent (\<1 month) acute coronary syndrome
* Anemia (hemoglobin \<10 g/dL)
* Pregnant or lactating women
* Patients with anticipated poor compliance, as assessed by the study investigator
* Patients within the exclusion period of another clinical study
* Patients under legal guardianship
Pharmacokinetics of Fluconazole IV as Prophylaxis or Therapy to ICU Patients

The pharmacokinetics of fluconazole are expected to be different in ICU patients compared to non-ICU patients. The investigators will determine fluconazole and free fluconazole concentrations in 20 ICU patients, who will get intravenous fluconazole as standard care. Switching to oral/enteral fluconazol is allowed after day 3.

A full pharmacokinetic curve will be taken on day 3 of iv therapy and limited pharmacokinetic curves on day 7 of iv therapy and/or on day 3 of oral therapy; trough levels will be taken daily after intravenous therapy.

The pharmacokinetics of fluconazole are expected to be different in ICU patients compared to non-ICU patients and healthy volunteers due to underlying disease(s). Therefore, extrapolation of data from healthy volunteers and non-ICU patients is not possible.

To be able to include 20 patients within the study duration, a multi-centre approach is necessary.

Patients will receive standard care, as stated in the product characteristics or according to local protocols. Blood sampling for pharmacokinetic analysis will be retrieved through a central venous catheter. A maximum of 62 milliliter blood in total will be drawn for this study. Patients will be monitored daily during the treatment period for adverse events of the study drug.

Full pharmacokinetic curves will be taken on day 3 of iv therapy. Limited pharmacokinetic curves will be taken on day 7 of iv therapy. These two moments of pharmacokinetic analysis will enable the determination steady state and enable the determination of intra-individual variability.

As probably not all patients included will be treated with iv fluconazole for 7 days, switching to oral/enteral therapy is allowed after day 3. To assess bioavailability limited pharmacokinetic curves will be taken on day 3 of oral/enteral therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is admitted to an ICU
2. Subject is at least 18 years of age on the day of the first dosing
3. Subject is managed with a central venous or arterial catheter

Exclusion Criteria:

1. Is known to be hypersensitive to azole antifungal agents
2. Documented history of sensitivity to medicinal products or excipients similar to those found in the fluconazole preparation
3. Has previously participated in this trial
Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

This is a Phase 2 study of pemetrexed and gemcitabine chemotherapy given once every 14 days to patients with advanced stage non-small cell lung cancer. This treatment is for patients that have not received any prior chemotherapy treatment for lung cancer. The primary goal is to find out if the tumor gets smaller or disappears with this treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Have a diagnosis of advanced stage non-small cell lung cancer.
2. Are able to be active at home and/or work.
3. Have not received chemotherapy for this cancer disease.
4. Have good organ function (for example, most blood work is normal).
5. Have completed any prior radiation treatment at least 4 weeks ago.

Exclusion Criteria:

1. Have been treated with an investigational/research drug within the last month.
2. Have cancer that has spread to the brain and is causing symptoms.
3. Have an active infection or other serious medical condition.
4. Have a second cancer in addition to non-small cell lung cancer.
5. Can not stop taking aspirin or other anti-inflammatory agents for 5-8 days.
Alcohol Consumption and Type 2 Diabetes Mellitus Risk in Nonalcoholic Fatty Liver Disease

This study explored the cross-sectional and prospective associations between light-to-moderate alcohol consumption (LMAC) and risk of type 2 diabetes mellitus (T2DM) in individuals with nonalcoholic fatty liver disease (NAFLD).


Eligibility Criteria:
Inclusion Criteria:

1. aged 18 years or above
2. undergoing annual health examinations in 2009 in Zhenhai Lianhua Hospital, Ningbo, China.
3. informed about the study

Exclusion Criteria:

1. female participants;
2. missing data on ultrasound, alcohol consumption, and T2DM status;
3. alcohol consumption \> 210 g per week, and binge drinkers;
4. with evidence of other liver diseases including viral hepatitis, autoimmune hepatitis, and drug-induced liver disease.
An Observational Study of Radial Access Embolization Procedures Using HydroPearl Microspheres

This registry study is designed to collect data on the procedural success and complication rates in real-world patients undergoing HydroPearl embolization procedures via radial access.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is ≥ 18 years old
2. Subject is scheduled for a procedure for treatment with HydroPearl microspheres using radial access.
3. Subject is willing and able to complete follow-up requirements
4. Subject is willing and able to sign a written Informed Consent form prior to participating in the registry.

Exclusion Criteria:

1. Unable to have a procedure with radial access for any reason.
2. Participating in another clinical study which, in the opinion of the investigator, could impact the results of this registry.
3. Pregnant or planning to become pregnant during the study.
Short-term Additive Effect of Topical Ketorolac on the Management of Diabetic Macular Edema With Intravitreal Bevacizumab

Purpose: To evaluate the short-term effect of adding topical ketorolac to the management of diabetic macular edema (DME) with intravitreal bevacizumab (IVB).

Setting: Ophthalmology department of Imam Hossein and Torfe Medical Centers. Ophthalmic Epidemiology Research Center of Shahid Beheshti University of Medical Sciences Methods: In a randomized double-masked placebo-controlled crossover clinical trial, all eyes with DME with best-corrected visual acuity (BCVA) between 20/40 and 20/400 were included. They should have had at least one intravitreal anti-VEGF injection in the past 2 months. They were randomized into two groups. Both groups received two IVB injections with 6-week interval. One group received topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval. The other group received the opposite medications. Best-corrected visual acuity (BCVA) and central macular thickness (CMT) evaluations were repeated at the termination of each treatment period i.e. at 6 and 12 weeks. The main outcome measure was BCVA changes in logMAR and the second outcome was CMT changes. The interim analysis of this study is presented in this report.


Eligibility Criteria:
Inclusion Criteria:

* BCVA≤20/40 and BCVA 20/400 and better
* History of at least 1 intra-viteral bevacizumab (IVB) in the last 2 months
* Requires 2 IVB in the next 12 weeks
* Macular thickness \>300 μm
* NO Other eye diseases
* Media clarity , pupillary dilation, and subject cooperation sufficient for adequate fundus photographs

Exclusion Criteria:

* hgb A1c\> 8
* high risk PDR
* Macular edema due to a cause other than diabetic retinopathy
* Any other ocular condition that visual acuity would not improve from resolution of edema (eg.foveal atrophy)
* Prior treatment with intravitreal or peribulbar corticosteroid injection during last 3months
* History of macular photocoagulation during the last 6 months
* intraocular surgery(except cataract surgery)
* Cataract extractionin less than 6 months ago
* Uveitis ,NVG ,exudative AMD, HR PDR.
* Uncontrolled glaucoma
* Vitreomacular traction or epiretinal membrane
Long Term Follow Up Study to COMP 001 And COMP 003 Trials (P-TRD LTFU)

The primary objective of this study is to assess the long-term efficacy of psilocybin with respect to use of new antidepressant treatment, hospitalisations for depression, suicidality, and depressive severity rated using the Montgomery and Asberg Depression Rating Scale (MADRS) over a total of 52 weeks (compared across the 1 mg, 10 mg and 25 mg psilocybin groups from COMP 001).

In this present study (COMP 004), the aim is to follow up participants from COMP 001 and COMP 003 in a long-term follow up study, with both remote and digital assessments, to explore the long term efficacy and safety of the three different doses of psilocybin (1 mg, 10 mg, and 25 mg) administered to patients with TRD as a monotherapy in COMP 001 and 25 mg psilocybin administered as an adjunct to an SSRI in COMP 003. Patients previously treated in COMP001 will be followed for approximately 40 weeks and patients previosuly treated in COMP003 will be followed for approximately 49 weeks giving a total follow up period of 52 weeks from psilocybin dosing.

Eligibility Criteria:
Inclusion Criteria:

Signed ICF Each participant having completed the final study visit of either COMP 001 or COMP 003 Ability to complete all protocol required assessment tools (including having access to the internet in order to complete the digital assessments) without any assistance or alteration to the copyrighted assessments, and to comply with all study visits

Exclusion Criteria:

Subject has any condition, for which in the opinion of the investigator, participation would not be in the interest of the subject eg participation could compromise the wellbeing of the participant or prevent, limit, or confound the protocol-specified assessments
Safety and Efficacy of Canagliflozin in Advanced CKD

The study objective is to characterize the pharmacokinetics (PK), pharmacodynamics, and surrogate measures of efficacy for canagliflozin in patients with advanced CKD, including those receiving HD.

As the CV and renoprotective effects of SGLT-2 inhibitors appear to be independent of glycemic control, the investigators hypothesize that canagliflozin will reduce albuminuria in patients with advanced CKD in the same manner as observed in patients with higher eGFR. The investigators also hypothesize that the 300 mg dose will be equally safe as the 100 mg dose but will have greater efficacy, given data which suggests efficacy correlates with drug exposure in patients without CKD.

Given its negligible renal elimination, the investigators hypothesize that exposure to canagliflozin 100 mg at steady state will not exceed the standard bioequivalence boundary of 80-125% in patients receiving HD, compared with published estimates with the 300 mg dose at steady state in individuals with preserved kidney function.

Substudy 1:

Patients with eGFR\<30 ml/min/1.73m2 and urine albumin to creatinine ratio (UACR)\>200 mg/g not receiving dialysis will receive canagliflozin 100 mg po daily for 12 weeks (phase 1). For participants who have tolerated the drug, canagliflozin will be increased to 300 mg po daily for an additional 12 weeks (phase 2) and then stopped. Each phase will be followed by a 2-week window to ascertain surrogate efficacy outcomes.

Substudy 2:

Adult patients on HD for at least 3 months without significant residual renal function will receive canagliflozin 100 mg po daily for 9 days.

Eligibility Criteria:
Inclusion Criteria:

(Substudy 1- SIP-AKiD-1):

* adult patients with eGFR \<30 ml/min/1.73m2
* urine albumin to creatinine ratio (UACR) \>200 mg/g
* not receiving dialysis.

(Substudy 2- SIP-AKiD-2):

* adult patients on hemodialysis for at least 3 months
* without significant residual renal function, defined as a urine output \<250 ml/24h.

Exclusion Criteria:

* Age \<18 years
* type 1 diabetes
* history of euglycemic ketoacidosis
* known hypersensitivity to SGLT-2 inhibitors
* recurrent severe genital or urinary tract infections
* history of atraumatic amputation, gangrene, or active skin ulcer
* use within the last 48 h of an SGLT-2 inhibitor or a combined SGLT-1 and SGLT-2 inhibitor
* liver disease defined by an ALT \> 3.0 times the upper limit of normal \[ULN\] or total bilirubin \>1.5 times the ULN or liver cirrhosis of any stage
* gastrointestinal surgery or gastrointestinal disorder that could interfere with trial medication absorption
* pregnancy
* currently breastfeeding
* any other clinical condition that would jeopardize patient safety while participating in this trial.
* Patients receiving digoxin, phenobarbital, phenytoin, rifampin, or ritonavir will be excluded if these agents cannot be safely discontinued
Trial of Pregabalin, Alprazolam, and Placebo in Subjects With Anxiety Prior to Dental Procedure

The primary purpose of the trial is to assess how effective pregabalin, alprazolam, and placebo are at reducing anxiety levels of subjects who take a dose of these treatments 4 hours before a scheduled dental procedure.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients 18 years of age or older who score 12 points or more on the Dental Anxiety Scale at screening and baseline evaluations and have a scheduled appointment for an elective dental procedure.

Exclusion Criteria:

* Current diagnosis of any of the DSM-IV anxiety disorders.
* Current diagnosis of major depressive disorder, dysthymia, schizophrenia or any other psychotic disorder, bipolar disorder, and eating disorders as assessed by the M.I.N.I. at screening, or current diagnosis of delirium, dementia, or body dysmorphic disorder.
Replace Glycemic Load and Satiety Study

The study is to examine the effect of four diets differing in glycemic index and amount of carbohydrate on blood sugar and insulin and in hunger, satiety, and vigor.

The extent to which a food raises blood sugar after its consumption is ranked using the Glycemic Index (GI). Foods with a high GI are those taht cause a large and rapid rise in blood sugar while those with a low GI produce small fluctuations in blood sugar. It is believed that low GI foods are advantageous for health since the swings in blood sugar and insulin resistant or diabetic. Interestingly, some studies suggest that low GI food make you less hungry and that this may play an important role in body weight regulation.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass index between 25-35 kg/m2
* Fasting serum glucose
* Fasting serum glucose \< 125 mg/dl
* Free of chronic disease
* Willing to eat only the foods that are provided by the Center during the diet periods
* Willing to abstain from the consumption of alcohol during the diet periods
* Regularly cycling and willing not to become pregnant using birth control (abstinence, barrier methods, partner surgically sterile
* Monophasic birth control (same dose each day)
* Hormone replacement therapy
* Post-menopausal (over 1 year without bleeding)
* Have had partial hysterectomy over the age of 55
* complete hysterectomy at any age

Exclusion Criteria:

* Documented presence of atherosclerotic disease
* Diabetes mellitus
* Renal, hepatic, endocrine, gastrointestinal, hematological or other systemic disease
* Body Mass Index \<25 or \> 35
* History of drug or alcohol abuse in the last year
* For women, pregnancy, breast feeding or postpartum \< 6 months
* History of depression or mental illness requiring treatment or medication within that last 6 months
* Multiple food allergies or significant food preferences or restrictions that would interfere with diet adherence
* Lifestyle or schedule incompatible with the study protocol
* Planned continued use of dietary supplements through the study trial
* Smoking or tobacco use