cyrilzakka/clinical-trials huggingface dataset:
Study of XL784 in Patients With Albuminuria Due to Diabetic Nephropathy

This clinical study is being conducted at multiple sites to determine the activity, safety and tolerability of XL784 when given daily to patients with albuminuria due to diabetic nephropathy. XL784 is a small molecule reno-protective metalloproteinase inhibitor, inhibiting both ADAMs (including ADAM10, a target of significant interest because of its important role in blood vessel formation and cell proliferation, and ADAM17/TACE, activation of which has been associated with renal deterioration) and MMPs (including MMP-2 and MMP-9). XL784 was specifically optimized to be MMP-1 sparing, which may be clinically significant because inhibition of MMP-1 has been hypothesized to be associated with musculoskeletal toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 or Type 2 diabetes mellitus with albuminuria, observed within 3 months of screening
* Prior to randomization, subject has a glomerular filtration rate (GFR) \>/= 40 mL/min
* Prior to randomization, the subject has albuminuria defined as ACR \>/= 500 mg/g
* Stable seated blood pressure at the screening visit and prior to randomization
* Subject has been on a stable dose and schedule of an angiotension converting enzyme (ACE) inhibitor and/or an angiotension receptor blocker (ARB) for at least 3 months before first dose of study drug
* If on antidiabetic medication, subject has been on a stable dose and schedule for at least 3 months prior to first dose of study drug
* Sexually active subjects must use an accepted method of contraception during the course of the study and for 3 months after
* Signed informed consent

Exclusion Criteria:

* Subject has participated in an investigational study and received an investigational drug within 30 days of the first dose of XL784
* Hemoglobin A1c (HbA1c) value of \>10% at screening
* Subject has had either organ transplantation or is currently on immunosuppressive therapy
* Non-steroidal anti-inflammatory drugs (NSAIDs) within 5 days of urine screening assessments
* Current diagnosis of one or more of the following conditions: 1) infection requiring parenteral antibiotics, 2) urinary tract infection, 3) hepatic dysfunction or disease, 4) symptomatic congestive heart failure, 5) unstable angina pectoris, 5) serious cardiac arrhythmia
* Clinically evident diabetic gastroparesis or motility disturbance
* Proteinuria not due to diabetic nephropathy
* Diltiazem or verapamil
* Ongoing condition where treatment with NSAIDs is anticipated (aspirin \</= 325 mg/day is allowed)
* Recent history of drug or alcohol abuse
* Pregnant or breastfeeding female subjects
* Known HIV and/or receiving anti-retroviral therapy
* Known allergy or hypersensitivity to any component of XL784 formulation
Factors Associated With Quality of Life in Knee Osteoarthritis

The aim of this study was to investigate the relationship between quality of life and factors that may affect quality of life (pain, stiffness, functional status and depression) in knee osteoarthritis.

Participants aged between 40-65 years, willing to participate in the study and diagnosed with knee osteoarthritis will be included in the study. Necessary demographic information will be obtained with the prepared data form. Numerical Rating Scale (NRS), Western Ontario and Mcmaster Universities Osteoarthritis Index (WOMAC Osteoarthritis Index), Knee Injury and Osteoarthritis Outcome Score (KOOS), Lower Extremity Functional Scale (LEFS), Beck Depression Scale, Short Form - 36 (Quality of Life Questionnaire) will be used for evaluation. The data obtained in the study will be entered into SPSS 17 package programme (Greasley, 2007). Minimum-maximum values, arithmetic mean and standard deviation will be used to evaluate numerical data, and frequency distributions and percentages will be used to summarise categorical data. The data of the study will be analysed using Analysis of Moment Structures (AMOS) statistical package programmes. In all analyses, p\<0.05 will be considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* Being diagnosed with knee osteoarthritis
* In studies between the ages of 40 and 65

Exclusion Criteria:

* Other orthopaedic surgery in the lower extremity
* Cognitive impairment at a level that prevents understanding and answering the questionnaire
* Presence of neurological disease
Accuracy of Using the CPAP Technique to Eliminate Air Leak and Prevent Excessive Endotracheal Tube Cuff Pressures

In common clinical practice, one means of ensuring an acceptable cuff pressure in endotracheal tubes (ETT) is to hold continuous positive airway pressure (CPAP) of 20-25 cmH2O and inflate the cuff of the ETT until no gas leak is noted around the cuff. The purpose of this study is to validate this technique by checking the intracuff pressure using a manometer after the cuff is inflated using the CPAP technique.


Eligibility Criteria:
Inclusion Criteria:

* Having a cuffed ETT placed per treating anesthesiologist
* \< 18 yrs of age.

Exclusion Criteria:

* None
The Relationship Between Atrial Fibrillation and Frailty in Community-Dwelling Elderly

Atrial fibrillation (AF) is the most common arrhythmias in clinical practice. Research investigating hospitalized patients have indicated there are deleterious effects of AF on patients besides the disease burden itself, including longer stay days for hospitalization, higher rates of frailty and increasing mortality rate after discharged in six months. In the community-dwelling research also found that elderly with AF have lower cognitive function, physical functional tests score and slower walking speed compared with the health ones. However, there is limited articles investigating the impact of AF on community-dwelling elderly, and the relationship between AF and frailty is also lack of discussion. According to the aged society and increasing prevalence of AF, the relationship between AF and frailty in community-dwelling elderly is warranting investigated.


Eligibility Criteria:
Inclusion Criteria:

* Older than 65 years old

Exclusion Criteria:

diagnosed with the following disease

1. Cardiovascular diseases: myocardial infarction, peripheral vascular diseases, aortic plaque
2. Cerebrovascular disease: stroke, transient ischemic attack, emboli
3. Heart failure
4. Participants who cannot finish the trial
Misoprosotol and Isosorbide Mononitrate for Induction of Second Trimester Abortion

the investigators aimed to study the efficacy and safety of nitric oxide donors when combined with prostaglandins in induction of second trimester abortion expecting that both drugs when used together will be of greater efficiency and associated with less side effects.

the study included 60 women with gestational age between 13weeks+0day and 26weeks+6days indicated for pregnancy termination due to maternal or fetal cause.

the study aimed to compare the effect of isosorbid mononitrate when combined with misoprostol and misoprostol when used alone in second trimester abortion, expecting that both drugs when used together will be more effective and associated with fewer side effects.

In this study 60 women were enrolled, divided into two groups. The first group (group I), 30 women received misoprostol and isosorbid mononitrate.

The second group (group II), 30 women received misoprostol and placebo. The primary aim of the study was the occurrence of complete abortion in the first 24 hours.

The study concluded that the combination of isosorbid mononitrate with misoprostol is more effective in second trimester abortion than misoprostol with placebo, but is associated with more side effects mainly headache.

Eligibility Criteria:
Inclusion Criteria:

* Age 16 -40 years
* Missed abortion
* Singelton pregnancy
* Gestationl age between 13 and 26 weeks of pregnancy
* Normal uterus and cevix on clinical examination
* Cervix is not dilatated
* No uterine activity and vaginal bleeding
* Written and informed consent by the patient
* Unscarred uterus

Exclusion Criteria:

* Presence of uterine contraction or bleeding
* Evidences suggesting of onset of spontaneous abortion as Previous trial to induce abortion
* Multifetal pregnancy
* Suspicion of septic abortion
* History of cervical surgery or manipulation
* Uterine anomaly
* IUD in situ
* Associtaed hemorrhagic disorder
* History of adverse effects to vaginally adminstered medication
* Inability to insert vaginal medication high in vagina
Prehabilitation for PAD Revascularization Patients

Patients undergoing elective revascularization of their peripheral artery disease will be randomized to a prehabilitation program or usual care prior to their scheduled procedure.

Patients undergoing elective revascularization for their peripheral artery disease will be randomized to a "prehabilitation" program prior to their surgery or to usual care. The prehabilitation program is self-directed program designed to improve health and quality of life prior to surgery. The program is currently offered to general surgery patients; this study will examine the feasibility and acceptability of such a program in a different patient population.

Eligibility Criteria:
Inclusion Criteria:

* Documented lower extremity PAD
* Ability to walk at least 1 block
* Sedentary
* Medical clearance from the surgical team
* Competent to provide consent

Exclusion Criteria:

* Life expectancy \< 6 months
* Co-morbidities which limit walking to a severe degree
* Signs of critical limb ischemia
* Recent or current enrollment in a formal exercise program
* Recent cardiovascular events including stroke, TIA, severe valve disease, etc.
* Current substance abuse
* Psychiatric disorder which limits ability to participate in study procedures
* Non-English speaking
Safety Study of LBH589 When Given in Combination With Lenalidomide and Dexamethasone in Adult Patients With Multiple Myeloma.

This study will evaluate the safety of LBH589 given in combination with lenalidomide and dexamethasone in adult patients with multiple myeloma


Eligibility Criteria:
Inclusion criteria:

* Patients must have a diagnosis of active multiple myeloma
* Patients must have received at least one prior line of therapy and their disease has relapsed..
* Patients must be suitable for treatment with lenalidomide \& dexamethasone.
* Adults ≥ 18 years old
* ECOG Performance Status ≤ 2
* Life expectancy \> 12 weeks
* Patients must have acceptable neutrophil and platelet counts as well as adequate kidney and liver function.
* Able to sign informed consent and to comply with the protocol

Exclusion criteria:

* Primary refractory MM
* Peripheral neuropathy ≥ CTCAE grade 2
* Impaired cardiac function or clinically significant cardiac diseases
* Impairment of GI function or GI disease that may significantly alter the absorption of LBH589
* Patients with diarrhea \> CTCAE grade 1
* Patients using medications that have a relative risk of prolonging the QT interval
* Concomitant use of CYP3A4 inhibitors
* Patients with a history of deep vein thrombosis or thromboembolism within \< 6 months prior to starting study treatment
* Patients who have undergone major surgery ≤ 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy
* Women who are pregnant or breast feeding or women of childbearing potential (WOCBP) not using 2 reliable forms of birth control
* Male patients whose sexual partners are WOCBP and who are unable to use a latex condom during sexual contact (even if they have undergone a vasectomy)
* Patients with any significant history of non-compliance to medical regimens or unwilling or unable to comply with the instructions given to him/her by the study staff.

Other protocol defined inclusion/exclusion criteria may apply
HIV Testing and Brief Alcohol Intervention for Young Drinkers in the Emergency Department

The purpose of this study was to determine whether a brief counseling intervention coupled with rapid HIV testing was feasible and effective at decreasing alcohol consumption and sexual risk behaviors among young, unhealthy drinkers presenting to the Emergency Department.


Eligibility Criteria:
Inclusion Criteria:

* 18-40 years old;
* engaged in at least one sexual risk behavior in past 90 days;
* alcohol consumption greater than NIAAA guidelines for at-risk drinking;
* unknown or negative HIV status and willing to be tested;
* able to provide contact information for follow-up;
* able to provide written informed consent.

Exclusion Criteria:

* known HIV positive status;
* medically or psychiatrically unstable.
HIV/COV in Ukraine-NL

Contradicting preliminary results are available on the impact of COVID-19 in people with HIV (PWH). How achieving goals of the HIV 90-90-90 cascade of care influences the risk of COVID-19 in PWH is unclear. The primary objective is to determine the impact of COVID-19 in PWH cohorts from Ukraine and the Netherlands.


Eligibility Criteria:
Inclusion Criteria:

HIV infected No registered objection to use of data

Exclusion Criteria:

None
Regional Differences of Cutaneous Irritation and Its Effect on Skin Barrier Recovery

Irritant contact dermatitis induced by sodium lauryl sulphate (SLS) is often used as a model for testing efficacy of various topical preparations. Aforementioned model is standardized and described in guidelines, but it is not explicitly stated where the irritation should be induced. Published clinical trials usually irritate volar aspect of forearms or upper back. Also, lower back and dorsal aspect of forearm are sometimes used.

Skin parameters vary depending on anatomic location of measured skin. There is a difference in stratum corneum thickness, hydration and transepidermal water loss across different locations, including between volar forearm and upper back.

Furthermore, regional difference in skin response to irritation by tape stripping and benzalkonium chloride were observed. Such differences are also possible in SLS irritation model. One study has shown higher, but not statistically significant, response of back in comparison to forearms, but it had a very small sample size (n=9).

Moreover, there are regional variations of topical preparations absorption. Hydrocortisone had 1,7 times higher absorption when applied to upper back in comparison to forearms. Those variations could be explained by different corneocyte size and number of their layers between back and hands.

Skin baseline properties and response to irritation seem to be dependent on anatomic position. Those differences could mean different response to treatment. Since published trials only tested efficacy of various preparations on one anatomic location, it is possible their results would be different if tested on other body parts. It could limit validity and usefulness of conducted trials. The aim of this study is to determine if there are regional differences of skin response to irritation and emollient cream treatment in irritant contact dermatitis model.


Eligibility Criteria:
Inclusion Criteria:

* young, healthy volunteers who gave written informed consent

Exclusion Criteria:

* skin disease, skin damage on measurement sites, use of corticosteroids and immunomodulators a month prior the inclusion and during the trial, use of emollients three days prior the inclusion in the trial, non-adherence to the trial protocol, exposure to artificial UV radiation, pregnancy and lactation
tDCS Effects on Brain Plasticity in Aphasia Treatment

The efficacy of conventional speech therapy alone for aphasia recovery is inconclusive. The prospective study will monitor the effects of combined language therapy and tDCS through structural and functional MRI.

The efficacy of conventional speech therapy alone for aphasia recovery is inconclusive. The prospective study will monitor the effects of combined language therapy and tDCS through structural and functional MRI.

This randomized, placebo-controlled, double-blinded pilot study will recruit ten chronic stroke patients with Broca's Aphasia randomly assigned either to sham or an anodal tDCS groups. Following speech and language assessment, all the participants will receive 20 minutes of individualized language therapy daily for ten days in two consecutive weeks. Simultaneously, the treatment group will receive 20 minutes of 2mA anodal HD-tDCS over the left IFG, while the sham group will receive the 30s of 2mA anodal HD-tDCS. Structural, resting state and task activated functional MRI will be performed. Data acquisition will be performed before, immediately after and two months after the treatment.

Repeated measure ANOVA for changes in picture-naming accuracy and response time will be performed as a within-subject factor between sham and anodal tDCS. Pearson's correlation coefficient of left IFG and its homolog in the right hemisphere through Independent component analysis (ICA) of low-frequency fluctuations in resting-state and task activated state will be compared for functional connectivity analysis for IFG and other major languages hubs for oral language production between groups.

Eligibility Criteria:
Inclusion Criteria:

1. History of a single unilateral left-hemispheric stroke,
2. Right handedness
3. Demonstrated features of Broca's Aphasia
4. Cantonese speaker
5. Comprehension sufficient to carry out tasks
6. No history of other neurological diseases

Exclusion Criteria:

1. Aphasia due to reasons other than Stroke, Traumatic brain injury
2. Bilateral or multiple brain lesions
3. Wernicke's aphasia and other speech disorders, degenerative, psychiatric or metabolic disorders
4. Deaf, blind, pregnant/ or preparing for pregnancy, cognitive issues, tattoos
5. Have cochlear implants, pacemaker, surgical nails for bone fracture, artificial joints, dental braces, dentures
6. Taking anti-depressant medications
A Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06700841, With Bioavailability/Food Effect Investigation

The main purpose of the study is to determine if PF-06700841 is safe and well tolerated when administered to humans. A secondary purpose is to assess what the body does to PF-06700841 and to assess what PF-06700841 does to the body when given as single and multiple doses. The pharmacokinetic properties of different forms of PF-06700841 may be studied (tablet and solution/suspension forms).


Eligibility Criteria:
Inclusion Criteria:

Key Inclusion Criteria for Healthy Subject Cohorts:

* Healthy male subjects and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive
* No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)

Key Inclusion Criteria for Psoriasis Subject Cohorts:

* Male subjects and/or female subjects of non-childbearing potential with a diagnosis of plaque psoriasis who are between the ages of 18 and 65 years, inclusive
* Have a diagnosis of plaque psoriasis for at least 6 months prior to first study dose

Exclusion Criteria:

Key Exclusion Criteria for Healthy Subject Cohorts:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
* Males of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product

Key Exclusion Criteria for Psoriasis Subject Cohorts:

* Currently have non plaque forms of psoriasis, (eg, erythrodermic, guttate, or pustular psoriasis).
* Have current drug induced psoriasis, eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, antimalarial drugs or lithium
* Males of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product
Venous Vascular Closure System Versus Manual Compression Following Single Shot Device AF Ablation

Prospective, randomized, controlled, multi-center study to compare the safety and efficacy of the Perclose ProStyle suture-mediated closure device (PPS) as to manual compression (MC) for venous hemostasis following single shot device (SSD) based pulmonary vein isolation (PVI).

The aim of this study is to show that the time to ambulation after PVI can be reduced by deploying vascular closure device versus manual compression and a figure-of-8 suture only. Safety, efficacy and feasibility of the PPS device should be proven, too.

Eligibility Criteria:
Inclusion Criteria:

* Patients age \>18
* Elective catheter ablation for atrial fibrillation using a 6 to 14 Fr inner diameter introducer sheath with a minimum of 1 and maximum of 2 femoral venous access sites

Exclusion Criteria:

* Active systemic or cutaneous infection, or inflammation in vicinity of the groin
* Platelet count \< 100,000 cells/mm3
* BMI \> 45 kg/m2 or \< 20 kg/m2
* Attempted femoral arterial access or inadvertent arterial puncture
* Procedural complications that interfered with routine recovery, ambulation, or discharge times
* Incorrect sheath placement
* Intraprocedural bleeding or thrombotic complications
* Access site-specific eligibility criteria to exclude problems with gaining access or location of sheath
The Relationship Between Stage of Diabetic Retinopathy and Retinal Blood Flow in Patients With IDDM During Euglycemic Clamp

Impaired retinal blood flow has been implicated in the pathogenesis of diabetic retinopathy. Patel et al. (1992) showed that retinal blood flow increases with the level of diabetic retinopathy. Grunwald et al. (1996) reported that patients with insulin dependent diabetes mellitus (IDDM) of relatively short duration have increased retinal blood flow, even before the onset of diabetic retinopathy. On the other hand the data of Bursell et al. (1996) indicate that IDDM patients have reduced retinal blood flow, when they have normal blood glucose levels, but this study may have considerable methodological limitations. Acute elevations of blood glucose levels, however, result in an increase in retinal blood flow (Grunwald et al. 1987, Bursell et al. 1996). Based on previous experimental data the investigators hypothesize that ocular blood flow is increased in early diabetes and reduced at later stages of the disease. Previous studies have demonstrated that metabolic conditions such as hyperglycemia influence outcome parameters and thereby might have confounded results regarding ocular blood flow in diabetic retinopathy. The investigators will therefore study patients with IDDM during euglycemic conditions.


Eligibility Criteria:
Inclusion Criteria:

Patients with IDDM:

* Age \>= 19 years
* Best corrected visual acuity \>= 0.8
* Ametropia \< 6 dpt

Healthy control subjects:

* Age and sex matched to the subjects in the patients group
* Best corrected visual acuity \>= 0.8
* Ametropia \< 6 dpt

Exclusion Criteria:

Any of the following will exclude a diabetic patient from the study:

* Presence of intraocular pathology other than diabetic retinopathy (for example: cataract, glaucoma, ocular hypertension)
* Hypertension (Systolic blood pressure \> 160 mm Hg or diastolic blood pressure \> 90 mm Hg)
* Previous laser photocoagulation treatment
* Pregnancy (in women)

Any of the following will exclude a healthy subject from the study:

* 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
* History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs
* Blood donation during the previous 3 weeks
* Pregnancy (in women)