cyrilzakka/clinical-trials huggingface dataset:
Cardiovascular, Renal and Metabolic Profile in Patients With Acute Myocardial Infarction (REN-ACS)

Aims

* assessment of renal artery stenosis incidence in consecutive AMI patients included in the Romanian National Programme of Primary Percutaneous Revascularisation;
* generating a cardio-renal-metabolic profile in patients with renal atherosclerotic disease;
* creating a local registry (based on European CARDS percutaneous interventional registries) which also includes renal, metabolic and vascular data;
* reporting long-term follow-up data on major cardiac adverse events (MACE) in the study group.

Gathered data:

* descriptive general demographic data;
* previous pathologies (ischemic heart disease, peripheral arterial disease, stroke, heart failure, previous percutaneous coronary interventions, coronary artery bypass grafting - CABG, known renal disease), cardiovascular risk factors (age, weight, height, abdominal perimeter, body mass index, smoking, sedentariness, diabetes, hypertension, dyslipidaemia);
* routine biological data and specific non-genetic biomarkers;
* information regarding primary PCI (less than 12 hours of ischemic symptoms): coronarographic details, type of used stent, periprocedural specific complications, final TIMI - thrombolysis in myocardial infarction - flow);
* echocardiography at admission (LVEF);
* metabolic data (obtained from body composition monitoring) - body water, body fat tissue;
* renal arteries angiographic details (two independent operators evaluate stenosis based on a predefined scale);
* renal dimensions;
* measurement of arterial stiffness through Sphigmocore pulsed-wave-velocity (24 hrs post-procedural, 2 velocities: carotid - femoral and carotid - radial);
* heart rate variability;
* in-hospital and one month follow-up MACE;

Eligibility Criteria:
Inclusion Criteria:

* adults with AMI (\<12h) diagnostic confirmed;
* included in the Romanian National Programme of Primary Percutaneous Revascularisation (for who the Guidelines recommend primary PCI);

Exclusion Criteria:

* none
A Study to Characterize Epidemiology, Clinical and Genetic Features of Kallmann Syndrome in Finland

Objective is to characterize epidemiology, clinical and genetic features of Kallmann syndrome in Finland.

Kallmann syndrome is comprised of idiopathic hypogonadotropic hypogonadism and anosmia (inability to smell). Associated phenotypes may include cryptorchidism, microphallus, bone deformations, mirror movements, hearing loss and infertility. Objective is to characterize epidemiology, clinical and genetic features of Kallmann syndrome in Finland.

Eligibility Criteria:
Inclusion Criteria:

* Kallmann syndrome
* Age 15 yrs or more

Exclusion Criteria:

* Severe mental retardation
Treatment of Schizoaffective Disorder Using Mifepristone

This study tests the hypothesis that mifepristone will diminish cognitive distortion and alleviate psychosis in patients with schizoaffective disorder.

You are invited to participate in a research study which evaluates the effectiveness of mifepristone (RU 486) in rapidly reducing the symptoms associated with schizoaffective disorder. Our group believes that the cognitive deficits (a decline in the ability to think clearly) and psychosis (hallucinations or delusions) exhibited in some affective disorders are driven by an excess of stress hormone effects (hypercortisolemia). Often the origin of this hormonal imbalance is unknown. Current treatment for schizoaffective disorder (characterized by mood swings and hallucinations and/or delusions) involves using a combination of antidepressant medication (for mood elevation), mood stabilizing medications (to prevent extreme high and low moods) and antipsychotic medication (for the correction of altered thinking). While these therapies are often effective, they can take several weeks or longer to work. We hope to uncover a quick, effective, safe therapy for the treatment of individuals with your condition.

Eligibility Criteria:
Inclusion Criteria:The subjects will be 30 inpatients or outpatients with schizoaffective disorder. Exclusion Criteria:Subjects must be between the ages of eighteen and seventy-five without major medical problems.
Study Evaluating Effects of Multiple-Dose Administration of Itraconazole on the Single Dose Pharmacokinetics of Conjugated Estrogens/Bazedoxifene in Non-Obese and Obese Postmenopausal Women

This study will assess if itraconazole will affect the blood levels of Duavee when they are given together. This study will also assess if a subject's body size affects the blood levels of Duavee.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy postmenopausal women, aged 40-64. Intact Uterus

Exclusion Criteria:

* The use of oral, vaginal, or transdermal estrogen, androgen or progestin-containing medications within 30 days before study drug administration.
Randomized Study For Minimally Invasive Splinted Implants

The purpose of this study was to evaluate the effect of a integrated system for inserting two splinted minimally-invasive implants, to retain mandibular over dentures, on the quality of life of edentulous patients.


Eligibility Criteria:
Inclusion Criteria:

* Edentulous
* Men and women
* Between 45 and 90 years of age
* Who had a persistent loss of stability and retention of their conventional mandibular dentures
* Without temporomandibular disorders

Exclusion Criteria:

* Uncontrolled systemic disease (eg, hypertension, diabetes)
* Severe osteoporosis (bone mineral density \> 2.5 SD below the young adult reference mean, plus 1 or more fragility fractures) and/or taking bisphosphonates
* Mental disorders
* Who had received radiotherapy in the 18 months prior to the trial
Technology-Based Distractions for Minor Procedures

The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset, Augmented Reality Headset) are more effective than the standard of care (i.e., no technology-based distraction) for decreasing anxiety and pain scores in pediatric patients undergoing various minor procedures (i.e lumbar punctures and cardiac catheterization). The anticipated primary outcome will be a reduction of overall cumulative medication and secondary outcomes include but are not limited to: physician satisfaction, discharge time, pain scores, anxiety scores, and procedure time.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patient age between 4-17
* English speaking
* Parental consent/patient assent
* Undergoing minor procedure(s) at LPCH or Stanford Hospital

Exclusion Criteria:

* Patient does not consent
* Legal guardian not present to obtain consent
* Patient with a significant neurological condition or major developmental disability
* Patient experiencing nausea
* Patient with active infection of the face or hand
* A history of severe motion sickness
* A history of visual problems
* A history of seizures caused by flashing light
* Major surgery within the last 48 hours
* Patients who are clinically unstable or require urgent/emergent intervention
* Patient or parental preference for general anesthesia
Dose Dense Abraxane in Adjuvant Chemotherapy for Breast Cancer

The purpose of this trial is to see if Abraxane, which is a new form of paclitaxel, is safe as a replacement form of paclitaxel in dose-dense chemotherapy. This trial will also determine if using Abraxane will allow patients to receive treatment every two weeks without requiring injects of G-CSF, a white blood cell stimulating growth factor.

* Patients will receive regular chemotherapy every 2 weeks for up to 8 cycles (approximately 16 weeks total)of treatment. During the first four cycles patients will be treated with Adriamycin and Cytoxan, and for the second four cycles they will be treated with Abraxane.
* Patients will be taught to give themselves injections with either short or long acting G-CSF as prescribed by their doctor for the first four cycles of chemotherapy. During the last four cycles (while the patient is taking Abraxane) they will not receive G-CSF unless they have low blood counts.
* If the patient has HER-2 positive breast cancer, they will also receive 52 weeks of Herceptin as part of standard cancer care and will begin to receive Herceptin at the same time they begin Abraxane (after 4 cycles of adriamycin and cytoxan treatment).
* This study involves a series of Quality of Life Questionnaires that will be completed prior to beginning study treatment, then again at 2 months, 4 months, 6 months, and 1 year after starting study treatment.
* The following tests and procedures will be performed at the time periods specified. Cycle 1-4 Day 1: Physical exam, vital signs, and blood tests. Cycle 5 Day 1: Physical exam, vital signs, blood tests, RVG (measurement of heart function) and questionnaire. Cycle 6 \& 7 Day 1: Physical exam, vital signs, and blood tests. Cycle 8 Day 1: physical exam, vital signs, blood tests, questionnaire. Follow-up (6 months and 1 year after cycle 1 day 1): questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed breast cancer, with clinical stage I, II, or III disease
* Must register at the beginning of adjuvant or neoadjuvant chemotherapy
* 18 years of age or older
* ECOG performance status of 0 or 1
* Normal organ and marrow function

Exclusion Criteria:

* Previous cytotoxic chemotherapy or therapeutic radiation therapy for any reason
* Pregnant or nursing
* Receiving any other investigational agents
* Patients with Stage IV breast cancer
* Current grade II or greater peripheral neuropathy or prior history of grade II or greater neuropathy
* Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Immune deficiency when treated with marrow-suppressive therapy or HIV-positive patients receiving anti-retroviral therapy
* Patients with sickle cell disease
* Known history of hyperviscosity syndrome
* Patients on lithium
a Physician-inititated Trial Investigating the iVolution Nitinol Stent

The objective of this clinical investigation is to evaluate the short-term (up to 12 months) outcome of treatment by means of the self-expanding iVolution nitinol stent in symptomatic (Rutherford 2-4) femoropopliteal arterial stenotic or occlusive lesions.


Eligibility Criteria:
Inclusion Criteria:

1. De novo lesion located in the femoropopliteal arteries suitable for endovascular treatment
2. Patient presenting with a score from 2 to 4 according to the Rutherford classification
3. Patient is willing and able to comply with specified follow-up evaluations at the predefined time intervals
4. Patient is \>18 years old
5. Patient understands the nature of the procedure and provides written informed consent, prior to enrollment in the study
6. Prior to enrollment, the target lesion was crossed with standard guidewire manipulation One target lesion is located within the native SFA: distal point 3 cm above knee joint
7. The target lesion has angiographic evidence of stenosis or occlusion
8. Length of the target lesion is ≤ 15 cm by visual estimation
9. Target vessel diameter visually estimated is ≥4 mm and ≤7 mm
10. There is angiographic evidence of at least one vessel-runoff to the foot

Exclusion Criteria:

1. Presence of a stent in the target vessel that was placed during a previous procedure
2. Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis
3. Previous bypass surgery in the same limb
4. Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics
5. Patients who exhibit persistent acute intraluminal thrombus at the target lesion site
6. Perforation at the angioplasty site evidenced by extravasation of contrast medium
7. Patients with known hypersensitivity to nickel-titanium or other study device components
8. Patients with uncorrected bleeding disorders
9. Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
10. Life expectancy of less than 12 months
11. Ipsilateral iliac artery treatment before target lesion treatment with a residual stenosis \> 30%
12. Use of thrombectomy, atherectomy or laser devices during procedure
13. Any patient considered to be hemodynamically unstable at onset of procedure
14. Patient is currently participating in another investigational drug or device study that has not reached the primary endpoint
A Study of the Safety, Tolerability, and Efficacy of IVT Pre-op 0.3mg Pegaptanib Sodium Versus Sham, for Management of Tractional Retinal Detachment and Vitreous Hemorrhage With Proliferative Diabetic Retinopathy

The purpose of this study is to assess whether preoperative pegaptanib sodium safely improves vitreous hemorrhage prior to surgical intervention and to evaluate the stability of pre-existing tractional retinal detachment.

Patients undergoing pars plana vitrectomy for active PDR with TRD will receive a single intravitreal pre-operative 0.3mg Macugen™ prior to surgery versus sham injection.

Specific timing of the injection will be at no sooner than 7 days and no longer than 14 days prior to surgery.

Patients will receive a preinjection fundus photo and another post injection photo the day of surgery as dictated by the operative schedule.

Some photos may be limited secondary to vitreous hemorrhage. Follow up visits after surgery will be one day, one week, one month, and three months.

Eligibility Criteria:
Inclusion Criteria:

* Best corrected visual acuity in the study eye between 20/30 and light perception (LP)
* Willingness to provide signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
* Age ≥ 18 years
* For sexually active women of childbearing potential, agreement to the use of an appropriate form of contraception (or abstinence) for the duration of the study

Exclusion Criteria:

* History of anti-VEGF treatment in the study eye
* History of previous pars plana vitrectomy in the study eye
* Intraocular surgery in the study eye within one month of the study
* Patients with extensive vitreous hemorrhage in conjunction with a rhegmatogenous retinal detachment
* Tractional retinal detachment from causes inconsistent with PDR, such as inflammation or trauma
* Any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition or if allowed to progress untreated could likely contribute to loss of at least 2 Snellen equivalent lines of BCVA over the study period.
* Active intraocular inflammation (grade trace or above) in the study eye
* Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
* Uncontrolled glaucoma in the study eye (defined as IOP≥ 35 mmHg despite treatment with anti-glaucoma medication)
* History of glaucoma-filtering surgery in the study eye
* History of corneal transplant in the study eye
Sorafenib Phase II Study for Japanese Anaplastic or Medullary Thyroid Carcinoma Patients

The objectives of this study are to evaluate safety, efficacy and pharmacokinetics of sorafenib for the treatment of Japanese patients with anaplastic thyroid carcinoma (ATC) or locally advanced or metastatic medullary thyroid carcinoma (MTC).


Eligibility Criteria:
Inclusion Criteria:

* Japanese patients with ATC (Anaplastic thyroid carcinoma) or locally advanced or metastatic MTC (medullary thyroid carcinoma)
* Not a candidate for surgery or radiotherapy with curative intent
* Histologically or cytologically confirmed ATC or MTC
* Measurable or non-measurable disease (but clinically evaluable) according to RECIST 1.1.
* Age \>= 18 years
* Adequate bone marrow, liver and renal function to be conducted within 14 days prior to treatment
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
* Life expectancy of at least 12 weeks

Exclusion Criteria:

* Histologic subtypes of thyroid cancer other than anaplastic or medullary carcinoma
* Prior anti-cancer treatment with tyrosine kinase inhibitors, monoclonal antibodies (licensed or investigational) that target VEGF or VEGF (vascular endothelial growth factor) receptors or other targeted agents
* Prior chemotherapy for thyroid cancer (only one regimen is allowed)
* Major surgery, open biopsy, or significant traumatic injury within 30 days prior to enrollment in the study.
* Subjects with tracheal, bronchial or esophageal infiltration with significant risk of bleeding but without having received local treatment prior to enrollment in the study
Use Repetitive Transcranial Magnetic Stimulation to Treat Somatic Symptom Disorder

This is a randomized double-blind sham-controlled crossover study; the interventions are high-frequency rTMS stimulation on left DLPFC and sham control. The study population is the patient with somatic symptom disorder. The primary outcomes are somatic distress and health anxiety.

Somatic symptom disorder (SSD) is a psychiatric diagnosis featured with somatic distress and health anxiety. It is overlapped with functional disorders. Whether it has effective treatment is a clinically important issue. Current evidence indicates that pharmacotherapy and psychotherapy are both helpful for SSD. Among other treatment options, repetitive transcranial magnetic stimulation (rTMS) is attached important in psychiatric field; it can cause activation or inhibition of specific brain regions via magnetic stimulation. Previous studies have disclosed that rTMS is helpful for depression, obsessive-compulsive disorder, post-stroke rehabilitation, etc. Regarding functional disorders, fibromyalgia has been found to be benefited from rTMS; the effective approaches include giving high-frequency stimulation on left M1 and dorsolateral prefrontal cortex (DLPFC). Chronic tinnitus was also found to have response to rTMS. SSD and fibromyalgia are highly overlapped; SSD and depression are often comorbid. Therefore, SSD may also be benefited from left DLPFC high-frequency stimulation. Our previous study revealed that dysfunction of anterior cingulate cortex (ACC) is associated with persistent interference of the somatic discomforts; stimulation on DLPFC can cause ACC activation. This study program was designed based on the above information. It is a randomized double-blind sham-controlled crossover study; the interventions are high-frequency rTMS stimulation on left DLPFC and sham control. The primary outcomes are somatic distress and health anxiety. There is not study about rTMS on SSD in literature; the investigators expect this study to be able to provide more understanding on this field.

Eligibility Criteria:
Inclusion Criteria:

* Patient with somatic symptom disorder (confirmed by psychiatrists)
* Age 20-70

Exclusion Criteria:

* Having psychotic symptoms or cognitive impairment
* Having potentially lethal illness
* Using cardiac pacemakers or defibrillators
* Currently pregnant or having plans to become pregnant within the next three months
* Received rTMS treatment within three months
* Cannot read the questionnaires by oneself
* Having to take the following medications persistently: bupropion \>300 mg/day、TCA、clozapine、chlorpromazine、foscarnet、ganciclovir、ritonavir、theophylline
The Importance of Non-invasive Methods in the Diagnosis of Lower Urinary System Symptoms.

The diagnosis of bladder outlet obstruction is made by pressure-flow studies, which is an invasive method. This study was conducted to evaluate non-invasive, effective, and low-cost diagnostic methods in male patients with bladder filling and emptying abnormalities.

Aims The diagnosis of bladder outlet obstruction is made by pressure-flow studies, which is an invasive method. This study was conducted to evaluate non-invasive, effective, and low-cost diagnostic methods in male patients with bladder filling and emptying abnormalities.

Methods The study included 219 male patients aged 50 and over, who were admitted between March 2020 and August 2020. Patients completed the Visual Prostate Symptom Score (VPSS) along with International Prostate Symptom Score (IPSS). Intravesical prostatic protrusion (IPP), prostate volume, bladder volume, and post voiding residual urine (PVR) were measured by suprapubic ultrasound. Urethral resistance was calculated using the Bladder Outlet Obstruction Number (BOON), and patients over -20 were considered obstructed.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of BPH Disease

Exclusion Criteria:

* Patients with previous urological surgery
* History of urological malignancy
* Systemic disease (diabetes mellitus, multiple sclerosis, etc.)
* Trauma that may cause LUTS
* Pharmacotherapy for LUTS
* Use diuretic antihypertensive
* PSA \> 4 ng/dl
* History of pelvic radiotherapy
* Visual problems that could not complete the VPSS test were not included.
Demineralized Dentin Graft With Hydrochloric Acid Versus Nitric Acid in Alveolar Ridge Preservation

The reduction in alveolar bone dimensions is an inevitable outcome after tooth extraction due to the healing events that results in bone modeling/remodeling. Alveolar ridge preservation is a successful approach that aids in reducing these changes greatly. Various techniques have been employed to achieve that outcome utilizing bone grafts and/or membrane. Dentin graft is a promising type that can overcome many of the limitations facing mainstream grafts. Autogenous source serve the advantage of providing graft with no cross-infection risk or immunogenicity. Moreover, the unique structure of dentin makes it suitable for osteoinduction and osteoconduction that yields favorite bone regeneration outcomes. Demineralization of dentin is essential to release trapped growth factors, expose collagen fibrils and enhance the grafts degradability and replacement by native tissues. Many acids have been investigated for the use in chairside preparation of the dentin graft and hence, clinicians are faced with different choices but little evidence regarding the acid which yield s better outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Non-restorable teeth
* medically healthy
* able to provide informed consent and attend follow-up period

Exclusion Criteria:

* pregnant
* smokers or alcoholic
* severe bone loss
In-depth ECG Analysis for the Extraction of Biomarkers of Cardiac Mechanical Dispersion

Left ventricular systolic dysfunction (LVSD) refers to impaired contraction of the left ventricle, and can lead to heart failure and death. Early identification of LVSD, which often remains asymptomatic for years, is therefore crucial to mitigate the associated risks through appropriate treatment. Echocardiographic screening of asymptomatic individuals is costly, requires access to experts, and the criteria for selecting potential high-risk individuals for screening remain unclear.

Unlike echocardiography, the electrocardiogram (ECG) is a relatively low-cost procedure, routinely available and requiring little technical training to set up the examination and collect data, making it an interesting tool for early detection of LVSD.


Eligibility Criteria:
Inclusion Criteria:

* Person who has received full information on the organization of the research and has not objected to the use of this data;
* Age ≥ 50;
* Persons who have undergone an echocardiographic examination and a 12-lead ECG examination during consultations at the CHRU de Nancy;
* Persons with at least one cardiovascular risk (obesity, diabetes, hypertension, etc.).

Exclusion Criteria:

* People with a history of heart disease (ischemic, valvular);
* Patients with significant 12-lead ECG abnormalities (complete bundle branch block, sequelae of myocardial infarction, etc.);
* ECG tracings or echocardiograms that cannot be analyzed.