cyrilzakka/clinical-trials huggingface dataset:
Cardiovascular Effects of Sunitinib Therapy (CREST)

Tyrosine kinase inhibitors such as sunitinib are used in the treatment of renal cell carcinoma and have significant off-target effects with cardiac toxicity and resultant ventricular cardiac dysfunction being a major concern. However, the mechanisms of these effects in humans remains poorly defined, as are the clinical methods to risk stratify and identify patients who will ultimately suffer from cardiac dysfunction. The goal of this multi-center study is to characterize the cardiovascular measures of cardiac function; 2) comprehensive measures of arterial function and left ventricular afterload; 3) biomarkers reflective of the pathophysiologic alterations. Through this work, the investigators will translate our basic understanding of sunitinib cardiotoxicity to humans and identify early predictors of sunitinib cardiotoxicity.

Tyrosine kinase inhibitors such as sunitinib have dramatically improved the overall management of certaincancers including renal cell carcinoma. However, recent data suggest that these therapieshave significant off-target effects with cardiac toxicity, including significant hypertension and ventricular cardiac dysfunction being a major concern. However, the biologic mechanisms underlying cardiotoxicty in humans remain poorly defined. Moreover, there is a critical need to develop methods to improve the risk stratification and early identification of patients who will suffer from hypertension and cardiac dysfunction with exposure to therapy. The over all objectives ofthis study are to further characterize the cardiovascular changes that occur with sunitinib exposure in order to improve our understanding of sunitib toxicity and determine early, mechanistically and clinically relevant predictors to identify patients at increased risk of hyptertension and cardiac dysfunction. The specific aims of this study are: 1) To define the changes in arterial hemodynamics that may occur with exposure to sunitinib, 2) To define the changes in sensitive echocardiographic measures of cardiac function that may occur with exposure to sunitinib, 3) To determine blood markers that are associated with changes in vasculature or cardiac function with exposure to sunitinib. and 4) To determine if there are early imaging or biomarker predictors of subitinib cardiotoxicity.

Eligibility Criteria:
Inclusion Criteria:

* Patients with renal cell carcinoma newly undergoing therapy with sunitinib.
* Age greater than or equal to 18 years
* ECOG performance status 0,1,2

Exclusion Criteria:

* Any contraindication to sunitinib therapy of note, patients with prior cardiovascular history are not excluded from this study, as long as there are no contraindications to sunitinib therapy.
TESRA: (Treatment of Emphysema With a Gamma-Selective Retinoid Agonist)

This 2 arm study will investigate the efficacy, safety and tolerability of RAR Gamma versus placebo in ex-smokers with moderate or severe emphysema treated with optimal COPD therapy. Following optimization of COPD therapy (up to 6 weeks) patients will be randomized to receive either RAR Gamma (5mg) or placebo once daily using a 2:1 ratio (active:placebo), in addition to their standard therapy. Following the double-blind treatment period, patients will enter a 4-week follow-up period. The anticipated time on study period is 1-2 years, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* patients of \>44 years of age, with \>10 pack-year smoking history;
* women not of child-bearing potential;
* ex-smokers (must have stopped smoking for \>=12 months) with clinical diagnosis of emphysema;
* willing to be switched to optimal COPD therapy.

Exclusion Criteria:

* off oral steroids \>28 days prior to enrollment;
* \>2 exacerbations of pulmonary symptoms requiring outpatient treatment, or \>1 exacerbation requiring hospitalization, within 12 months prior to screening;
* exposure to synthetic oral retinoids in past 12 months;
* history of allergy or sensitivity to retinoids.
Investigating the Impact of Ex Vivo Ozone Injection on Synovial Fluids in Patients Diagnosed With Knee Osteoarthritis

The objective of this study is to examine the effect of varying ozone doses on the levels of pro-inflammatory cytokines in synovial fluid collected from individuals with knee osteoarthritis.

In this study, synovial fluid samples will be collected from patients diagnosed with knee osteoarthritis for in vitro studies. The synovial fluid will be collected under sterile conditions by a joint puncture, and ultrasonography will be performed before sample collection. The synovial fluid samples will then be transferred to sterile urine culture tubes, with one containing only synovial fluid and the others containing synovial fluid and ozone gas. Afterward, the synovial fluid samples will be centrifuged, and the upper portion will be stored at -80°C for biochemical analyses. The total protein content will be measured using a commercial kit based on the Bradford method, and the total antioxidant level and Total oxidant levels will be measured using commercially purchased kits according to the manufacturer's instructions. The oxidative stress index will be calculated using the formula (TOS/TAS) and will be normalized to the total protein content measured in the synovial fluid.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with knee osteoarthritis.
* Giving consent to participate in the study.

Exclusion Criteria:

- Not giving consent.
Brain Neuronal Networks, Chemosensory and Trigeminal Functions in Allo-HSCT

The goal of this prospective, cohort study is to learn about smell, taste and trigeminal dysfunction in patients receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT). The research team hypothesizes that treatment with allo-HSCT will induce:

* Distortion of taste and smell and trigeminal functions like cooling, tingling, and burning sensations.
* Reduced saliva production leading to oral dryness and dental caries.
* Changes in the connectivity of the taste-, smell- and pain-cortical brain regions.

Participants will undergo various tests:

* Smell function assessment with Sniffin' Sticks.
* Taste function assessment with Taste Strips.
* Oral trigeminal function assessment with von Frey filaments .
* Salivary assessment with the Summated Xerostomia Inventory-Dutch questionnaire.
* Salivary flow will be measured using salivary flow rate - stimulated whole saliva (SWS).
* A clinical oral examination will be done to obtain a Clinical Oral Dryness Score.
* Qualitative smell, taste and trigeminal dysfunction will be assessed using a questionnaire.
* Radiological and clinical examinations will be performed to evaluate dental and oral mucosal status.
* Quality of life using questionnaire.
* Nutritional status using questionnaire.
* Magnetic resonance imaging of the brain will be taken to capture regions-of-interest for the three different networks of interest; (i) the gustatory network reflecting changes in taste perception, (ii) the olfactory network, related to the changes in smell, and (iii) the pain matrix reflecting pain.

There will be a comparisons between the patients and healthy controls.

Eligibility Criteria:
Inclusion Criteria:

• patients receiving myeloablative conditioning for a first-time allo-HSCT and diagnosed with either a leukemia or a myelodysplastic syndrome

Exclusion Criteria:

* disorders affecting the oral cavity including poor tooth-status
* those using drugs affecting the gustatory/olfactory functions
* those with brain disorders
* those who have a chronic disorder affecting the immune system, have cancer or who are pregnant.
The Effect of Stress Ball in Reducing Anxiety and Fear in 6-12 Year Old Children

The aim of this study was to determine the effect of stress ball application on procedure-related anxiety and fear during plaster cast procedure in children aged 6-12 years.

Children aged 6-12 years will be randomly divided into two groups: stress ball and control group. Interventions will be applied 1 time per day (2 sessions) for 2 days. Children in the experimental group will be given a stress ball during the plaster procedure and will be asked to squeeze it during the procedure. Children will be assessed before, during and after the intervention. Fear and anxiety related to the cast procedure will be assessed using the Children's Fear Scale, and the Children's Anxiety Scale - Statefulness Scale. In addition, children's heart rate, respiration, blood pressure and SPO2 will be measured.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 6 and 12 years (over 12 years old)
2. Absence of any physical and mental illness,
3. Not having taken analgesics in the last six hours
4. Hospitalization was for diagnostic or therapeutic purposes
5. The child and parents are comfortable speaking and understanding Turkish.

Exclusion Criteria:

1. Children hospitalized for surgery will not be included in the study.
2. Those who are outside the inclusion criteria will not be included in the study.
Excimer Laser Combined With DCB Compared With Angioplasty Alone in the Treatment of Infrapopliteal Lesions.

This study was designed to compare excimer laser combined with drug-coated baloons with angioplasty alone in the treatment of infrapopliteal lesions in patients with critical limb ischemia.

This is a randomized study comparing excimer laser combined with drug-coated baloons with angioplasty alone in the treatment of infrapopliteal lesions in patients with critical limb ischemia.

Eligibility Criteria:
Inclusion Criteria:

* The treatment vessel is DeNovo
* Stenotic (\>50%) or occlusive atherosclerotic disease of infrapopliteal artery(s)
* Reference target vessel diameter between 2-4.0 mm by visual assessment
* Documented Rutherford Class 4 or 5 symptomatic critical limb ischemia
* The patient must be \>18 years of age
* Life-expectancy of more than 12 months
* The patient has no child bearing potential or negative serum pregnancy test
* within 7 days of the index procedure
* The patient must be willing and able to return to the appropriate follow-up times for the duration of the study
* The patient must provide written patient informed consent that is approved by the ethics committee

Anatomic Inclusion Criteria:

* All inflow lesions successfully (\<30 residual stenosis) treated prior to target lesion treatment during same procedure or according standard of care without unresolved complications
* At least one angiographically visible target at the ankle for establishment of straight line flow.

Exclusion Criteria:

* Patient refusing treatment
* The target vessel segment diameter is not suitable for available catheter design.
* Unsuccessfully treated endovascular or bypass( \>30% residual stenosis) proximal ( iliac, superficial femoral, popliteal) inflow limiting arterial/graft stenosis
* Lesion lies within or adjacent to an aneurysm
* The patient has a known allergy to heparin, Aspirin or other antiaggregant therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies.
* The patient has a history of prior life-threatening contrast media reaction.
* The patient is currently enrolled in another investigational device or drug trial.
* The patient is currently breast-feeding, pregnant or intends to become pregnant.
* The patient is unable to provide informed consent
* The patient has end stage renal disease (currently on any form of dialysis)
* Known Left Ventricular Ejection Fraction \< 35%
* The patient has had a myocardial ischemia within 30 days prior to enrollment
* The patient has had a cardiovascular accident within 90 days prior to enrollment
* Serum Creatinine \> 150 µmol
* The patient has a previous bypass in the target limb
* The patient has a current systemic infection
Prospective Study of FMT for Acute Intestinal GVHD After Allo-HSCT

Acute intestinal GVHD is the main cause of death after allo-HSCT, and FMT is a new treatment method for this disease. In this prospective study, the investigators will recruit intestinal GVHD patients to demonstrate the efficacy and safety of FMT.

Graft-versus-host disease (GVHD) is a common complication of allogeneic hematopoietic stem cell transplantation (allo-HSCT), of which intestinal GVHD is a particularly serious one, which is the main cause of death after allo-HSCT. Recent studies have demonstrated that intestinal flora imbalance is strongly associated with the risk of infection and mortality in patients with allo-HSCT. On the basis of this theory, fecal microbiota transplantation (FMT) may be an effective method for GVHD, that is, fecal suspension from healthy individuals is inputted into the digestive tract of patients through some methods, so as to restore the microbial community diversity of patients. In this prospective study, the investigators aimed to demonstrate the efficacy and safety of this treatment.

Eligibility Criteria:
Inclusion Criteria:

1. received allo-HSCT due to a hematopoietic disease
2. corticosteroid resistant/dependent intestinal GVHD
3. ECOG≤2
4. Sign informed Consent
5. No major organ dysfunction

Exclusion Criteria:

1. uncontrolled or severe infections
2. patients with severe liver and kidney function, cardiopulmonary insufficiency, epilepsy, and central nervous system disorder
3. high-risk bleeding
4. ANC\<0.5×10\^9/L or PLT\<20x10\^9/L
5. hepatitis B, tuberculosis, syphilis, and HIV antibody positive or acute phase of any infectious disease
6. patients participating in other clinical trials
7. patienta who suffer from mental illness
Diagnostic Value of DECT Scan Compared to Diagnostic Needle Aspiration

Rationale: Gout is a disease with growing incidence and complexity due to increased life expectancy, co-morbidity and medication. The disease can be diagnosed by microscopy, demonstrating monosodium uric acid (MSU) in synovial fluid of the affected joint or in tophi (subcutaneous or peritendinous MSU depositions). In daily practice, however, the diagnosis is difficult to ascertain due to sampling error (no synovial fluid acquired because the needle was not exactly placed in the affected joint, or the location of the gout might have been extra-articular e.g. around tendons) or to a different cause of acute arthritis (e.g. infection, reactive arthritis). Recently, Dual Energy CT scan has become available. This technique allows the visualization and quantification of MSU. Although imaging modalities such as DECT show promise in the classification of gout, the studies to date have been small and have primarily involved people with established disease.

A study with cross-sectional design in which patients for whom the clinical questions "does this patient have gout?" are referred for participation may contribute to assess the value of DECT scan in diagnosing acute arthritis caused by gout.

Objective: Assessment of value of DECT scan in diagnosing acute arthritis, caused by gout.

Study design: Prospective Study population: Patients with acute mono or oligo arthritis without prior diagnosis, the rheumatologist has an indication for diagnostic needle aspiration.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In current daily practice, patients with acute mono- or oligo-arthritis without prior diagnosis undergo a diagnostic aspiration of the affected joint. This can be done by blind aspiration or ultra sound guided aspiration depending on the judgement of the rheumatologist. The aspirated synovial fluid is then assessed by polarized microscopy to detect MSU crystals. The diagnostic value of DECT in acute gout attacks had not yet been established and is therefore not used in daily practice. In this study all patients undergo DECT scan to assess the value of DECT scan in diagnosing acute arthritis caused by gout. If the DECT scan demonstrates MSU depositions and the diagnosis of gout was not ascertained prior to DECT scanning by MSU crystals in the synovial fluid, then additional ultrasound guided aspiration will take place, with knowledge of DECT results, followed by repeat microscopy


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Mono or oligo arthritis (2-3 swollen joints)
* Indication for diagnostic aspiration of an inflamed joint in which gout is one of the possibilities

Exclusion Criteria:

* Polyarthritis ( up to 4 swollen joint);
* Chrystal proven gout in history
* Patient is on uric acid lowering therapy (Allopurinol, Benzbromaron, Febuxostat)
* Hip arthritis\*
* Metal or prosthesis of the inflamed joint
* Highly suspicion of infectious arthritis
* Pregnancy
* Contra indication of joint aspiration (skin infection, hemophilia)
* No informed consent
Anterior Segment Anatomic Parameters for Risk Profiling of Primary Angle-closure Glaucoma

The goal of this observational study is to examine the anterior segment anatomical parameters associated with the scleral spur and cornea for risk profiling of primary angle-closure glaucoma (PACG). The main question it aims to answer is:

• Are there new anatomical parameters of the anterior segment of the eye that can be used early for risk profiling for PACG? Researchers will compare PACG and narrow angle groups to see if there are some anatomical parameters that can distinguish the two.

We aimed to examine the anterior segment anatomical parameters associated with the scleral spur and cornea for risk profiling of primary angle-closure glaucoma (PACG).

This retrospective study included 84 patients with PACG and 84 patients with narrow angles (NA). We collected parametric measurements obtained using anterior-segment optical coherence tomography and IOLMaster 700. Univariate and multivariate logistic regression models were used to compare the ocular parameters between the NA and PACG groups as well as to identify risk factors for PACG. The predictive performance of each parameter was evaluated using the area under the receiver operating characteristic curve (AUROC) analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Primary angle-closure glaucoma （PACG) was defined as an occlusion angle with peripheral anterior synechiae and intraocular pressure (IOP) \> 21 mmHg or associated with glaucomatous optic neuropathy. The following conditions were identified as possible glaucomatous optic neuropathies, including a vertical cup-to-disc ratio ≥ 0.6, vertical cup-to-disc ratio asymmetry ≥ 0.2, optic disc haemorrhage, and visible retinal nerve fibre layer defect.
2. Participants with narrow angle (NA) were selected from among patients with cataracts. NA was defined as a trabecular-iris angle (TIA) \< 15° on anterior segment optical coherence tomography, with the exclusion of glaucomatous optic neuropathy or visual field loss.

Exclusion Criteria:

(1) severe systemic disease, (2) secondary angle-closure glaucoma, (3) other ocular diseases, (4) history of intraocular surgery, and (5) unclear examination images.
Central Mechanisms of Intervention for Low Back Pain

Body-based interventions have consistently shown clinical effectiveness in patients with back pain. The primary objective for this study is to compare the effect of body-based interventions commonly used in the management of low back pain on behavioral and cortical measures of pain sensitivity and central sensitization of pain. Participants will be randomly assigned to receive one of the interventions or be in a control group. The central hypothesis for this proposal is that spinal manipulation, a specific form of body-based intervention, inhibits central sensitization of pain normalizing pain sensitivity more rapidly than other interventions. The completion of the proposed study will elucidate underpinning mechanisms of body-based interventions. Identification of these mechanisms will improve the clinical application and utilization of these interventions in the management of musculoskeletal pain conditions, especially back pain.

170 participants will be randomly assigned to receive one of the interventions or be in a control group. The investigators will use of a model of experimentally induced low back pain to investigate the effects of manipulative and body-based interventions in acute onset low back pain without some of the clinical confounds. The investigators will collect fMRI and psychophysical data about pain sensitivity before and after the induction of pain, and before and after interventions for that pain.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 to 40 years
* able to read and understand spoken English

Exclusion Criteria:

* Previous participation in a conditioning program specific to trunk extensors in the past 6 months
* Any report of back or leg pain in the past 3 months
* Any chronic medical conditions that may affect pain perception (e.g., diabetes, high blood pressure, fibromyalgia, headaches), kidney dysfunction, muscle damage, or major psychiatric disorder
* History of previous injury including surgery to the lumbar spine, renal malfunction, cardiac condition, high blood pressure, osteoporosis, or liver dysfunction
* Consumption of any drugs (e.g., caffeine, alcohol, theophyline, tranquilizers, antidepressants) that may affect pain perception or hydration status from 24 hr. before participation until completion of the investigation
* Performance of any intervention for symptoms induced by exercise and before the termination of their participation or the protocol
* Recent illness
* Any contraindication to MRI e.g.: pacemakers, metal implants which are not MRI compatible (e.g. aneurysm clip), pregnancy and severe claustrophobia.
Music and Sounds for ECV

This international study is looking to see if the addition of music and sound on the maternal abdomen encourages fetal position change from breech to vertex in near term women.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women near term with breech presentation.

Exclusion Criteria:

* women with a contraindication for vaginal birth
Titan® One Touch Release Inflatable Penile Prosthesis

The purpose of this study is to assess the ease of deflation of the Titan® OTR pump.


Eligibility Criteria:
Inclusion Criteria:

* Participant has an estimated life expectancy of more than 5 years
* Participant has been diagnosed with erectile dysfunction (impotence)
* participant is willing to have the Titan OTR IPP implanted
* Participant is able and willing to complete all follow-up visits and procedures indicated in the protocol

Exclusion Criteria:

* Participant is unable or unwilling to sign the Informed Consent Form and /or comply with all follow-up requirements according to the study protocol
* Participant had a previous penile prosthesis or prior penile enlargement surgeries
* Participant has a compromised immune system, such as systemic lupus erythematosus, discoid lupus, or scleroderma
* Participant has had a myocardial infarction or coronary artery stent placement within 2 months prior to treatment
* Participant currently has uncontrolled or severe diabetes or other disease significantly reducing wound healing ability
* Participant does not have the manual dexterity or mental ability to operate the pump
* Participant has chordee or priapism
* Participant has penile sensory neuropathy
* Participant has serious bleeding disorder