cyrilzakka/clinical-trials huggingface dataset:
Novasight Hybrid Intravascular Ultrasound and Optical Coherence Tomography System (IVUS OCT)

Collection of coronary images with a hybrid IVUS OCT system.

A prospective observational imaging study in patients undergoing coronary angiography and intravascular imaging for either diagnostic purposes or for PCI following a presentation with either stable angina or an acute coronary syndrome.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is at least 18 years old.
2. Patients arriving for coronary angiography or possible PCI with stable angina or acute coronary syndrome (including unstable angina, NSTEMI or STEMI).
3. Patients with STEMI may be undergoing subsequent staged PCI to additional coronary stenoses after the index STEMI event has been successful treated with primary PCI.
4. Vascular access of at least 6F.
5. Patient provides informed, written consent for participation in the study.
6. A target lesion is present in a suitable artery for intravascular imaging.

Exclusion Criteria:

1. Angiographic evidence of severe calcification
2. Marked tortuosity that precludes imaging of a target coronary artery.
3. GFR (Glomerular filtration rate) \<35 mL/min.
4. Patients in cardiogenic shock.
5. Women of child bearing potential, in whom pregnancy cannot be excluded.
6. Patients of age \< 18 years old.
7. Patients with an allergy to contrast.
8. Patients unable to grant informed, written consent for participation in the study.
Individualizing Corticosteroid Use in Pneumonia

In this study, researchers propose a unique (individualized) approach to steroid treatment seeking to give the right dose of steroid to the right patient and at the right time. This study seeks to compare usual care to an individualized steroid dosing strategy by testing a marker of inflammation in the blood called C- reactive protein (CRP). The overall goal is to reduce an individual's exposure to steroids and the risk of potential side effects thereby increasing the potential benefit of using steroids to control inflammation in pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized adult (≥ 18 years) patients.
* Community acquired pneumonia.

Exclusion Criteria:

* Contraindications or unwillingness to use corticosteroids by patient or provider.
* History of adrenal insufficiency, septic shock, or another absolute indication for steroid use.
* Suspected pulmonary vasculitis or other autoimmune pulmonary disorder.
* Positive pregnancy test
* Comfort care.
Faslodex Specific Clinical Experience Investigation

The purpose of this study is to confirm the safety profile such as the frequency of serious adverse events or any unexpected adverse events and overall efficacy of Faslodex for long term treatment in daily clinical practice.

MC MD

Eligibility Criteria:
Inclusion Criteria:

* Patients treated with Faslodex for the first time due to postmenopausal breast cancer

Exclusion Criteria:

* None
The Effects of Regular Mountain Hiking on Hopelessness in Chronically Suicidal Patients

Suicide is a major public health issue with estimated 1 million deaths worldwide within the last year. Physical activity and nature recreation might be protective factors against suicidal behaviour, suicidal ideation and contributing factors like depression and hopelessness.

In this randomized controlled cross-over intervention study the investigators aim to investigate the physical and psychological effects of a 9 weeks hiking program in chronically suicidal patients. The investigators aim to enroll 24 patients suffering from chronic suicidality, defined as at least one attempted suicide and a hopelessness greater than 26 in Beck's Hopelessness Scale summary score. At baseline patients will undergo pre-tests including questionnaires to assess suicide ideation, hopelessness, depression, anxiety, quality of life and health-related physical activity, physiological investigations to assess exercise capacity and blood investigations. Randomly assigned 12 patients start with the 9 weeks supervised mountain hiking program followed by a 9-week-period without supervised exercise program. The other 12 patients start with 9 weeks without supervised exercise program followed by a 9-week-period of supervised mountain hiking program. The mountain hiking program includes 2 training sessions per week with a duration of 3 hours per session. The hiking intervention will be performed within 70-85% of heart rate reserve and gymnastics for body and nature perception, mobilisation and stretching will enrich the training program. Further investigations including questionnaire-assessments, assessment of exercise capacity and blood investigations will be scheduled 9 and 18 weeks after the study start. In addition a daily assessment of several suicide risk-factors based on a web-based questionnaire will be done over the full study period. Within this mountain hiking program the investigators hope to reduce hopelessness in chronically suicidal patients.


Eligibility Criteria:
Inclusion Criteria:

Chronically suicidal defined as:

* at least one attempted suicide
* BHS summary scale \> 26

Exclusion Criteria:

* Coronary heart disease defined by angina pectoris or relevant ST-changes during exercise or myocardial infarction in the last 6 months
* not oriented in time and space
* demented
* acute psychotic
* cognitively impaired
* insufficient german language skills
Ovarian Reserve in Diabetes Mellitus

Type 1 diabetes mellitus is a common autoimmune disease. It affects women of all ages including reproductive years. Hyperglycemic condition in diabetes can cause organ damage. This study aims to measure serum hormones including FSH, LH, E2, AMH, ovarian volume and antral follicle count (indicators of ovarian reserve) in women with and without type 1 diabetes mellitus.

Type 1 diabetes mellitus is a common autoimmune disease. It affects women of all ages including reproductive years. It is showed that hyperglycemic state in diabetes results in organ damage like kidneys and eyes. Ovarian reserve is important for the reproductive period. The measurements of serum hormones including follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2) and anti-mullerian hormone (AMH) will give us an idea about the ovarian reserve. The investigators aim is to measure ovarian reserve parameters in patients diagnosed with type 1 diabetes mellitus and to compare them to healthy controls. Serum FSH, LH, E2 and AMH will be measured on the 3rd day of the cycle. Antral follicle count and ovarian volume measurement will be done with ultrasonography. Ovarian reserve markers will be compared between the groups.

Eligibility Criteria:
Inclusion Criteria:

* Reproductive age group women: 18-40 years
* Women diagnosed with type 1 diabetes (case group)
* Women without type 1 diabetes (control group)

Exclusion Criteria:

* Women with PCOS (polycystic ovary syndrome)
* history of ovarian surgery
* Body mass index (BMI) over 30
LIFT With or Without Injection of BM-MNCs

To improve the outcome of LIFT, some authors used a combined approach of LIFT. Pooled analysis of seven studies including 192 patients revealed a success rate of 83.5 % after combined LIFT approach. The use of bone marrow aspirate concentrate (BMAC) in surgery is not entirely new as it has been widely used in the treatment of bone defects, mandibular reconstruction, maxillary sinus augmentation and in critical limb ischemia.

A previous study concluded that the use of BMAC to augment external anal sphincter repair strengthens wound healing by transferring cells responsible for healing directly to the site of repair. The current study aimed to assess the outcome of local injection of bone marrow mononuclear cells (BM-MNCs) in conjunction with LIFT as compared to LIFT alone in regards to healing rate, time to healing, and ultimate success rate.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients of either gender presented with cryptoglandular trans-sphincteric anal fistula

Exclusion Criteria:

* Patients with secondary anal fistula
* Immunocompromised patients
* Patients with previous pelvic radiotherapy
* Pregnant women
* Patients with ASA (American society of anesthesiologists) III or higher.
Observation on the Immune Persistence of People Aged 10-60 Years Old Immunized With Five Doses of Rabies Vaccine

Evaluation of immune persistence after rabies vaccination in 150 people.

150 subjects aged 10-60 were recruited to inoculate the frozen human rabies vaccine (Vero cells) produced and marketed by Changchun Zhuoyi Biological Co., Ltd. in the whole process of 0, 3, 7, 14 and 28 day immunization. The immunogenicity persistence and safety of the test vaccine were evaluated 14 days, 6 months and 12 months after the whole process of vaccination.

Eligibility Criteria:
Inclusion Criteria:

* 10-60 years old；
* Temperature on the day of admission≤37.0 ° C (axillary temperature).

Exclusion Criteria:

* Have a history of rabies vaccine immunization or use of rabies virus passive immunization agents；
* Has been diagnosed with congenital or acquired immunodeficiency disease;
* Pregnancy (including positive urine pregnancy test) or lactation, planned pregnancy preparation within 2 months.
One-Year Follow-up Safety Study in Subjects Previously Implanted With VC-01™

The purpose of this trial is to evaluate the long-term safety in subjects previously implanted with VC-01™ combination product.


Eligibility Criteria:
Inclusion Criteria:

* Previous implantation of VC-01™ combination product with subsequent explantation of all VC-01 units.

Exclusion Criteria:

* There are no exclusion criteria for this trial.
Sub-study for the Validation and Calibration of Data Regarding Physical Activity, Anthropometry and Diet

This study was an update and amplification of exposure measurements of the EPIC-Potsdam Study, which started in 1994-1998.

The sub-study was conducted in the German Institute of Human Nutrition according to an approved study protocol.

The study program included comprehensive surveys on diet and lifestyle (smoking, physical activity, and anthropometry). The aim was to achieve repeated measurements in a sub-cohort of about 600 people to validate (measurement error correction) and calibrate (adjustment of insufficient data collected to the actual data location) existing baseline data in the entire cohort (EPIC-Potsdam cohort).

To this end, within age groups and by gender, active EPIC participants were then randomly selected in the years 2009 to 2012 from the cohort, contacted and invited to re-visit the respective study center. 816 subjects were acquired for re-examination, participation rate was 56.4%.

Each participant gave informed consent. The study protocol has been approved by the Ethics Committee of the Medical Association of the State of Brandenburg, Cottbus, on 18/12/2009.

The information in this section are study hypothesis and contains no results or conclusions.

Eligibility Criteria:
Inclusion Criteria:

* Participants in the EPIC study who meet the following three conditions were eligible for invitation to the re-examination:

  1. actively participating in the EPIC-Potsdam follow-up
  2. current address in Brandenburg or Berlin
  3. phone number known

Exclusion Criteria:

* Not meeting the above stated criteria
Patient-Directed Antimicrobial Duration in Acute Uncomplicated Pyelonephritis

This pilot study will randomize 40 female patients with acute uncomplicated pyelonephritis to receive standard duration of therapy versus patient-directed antimicrobial duration (PDAD). The primary objectives of this pilot trial are to determine the feasibility and safety of conducting a full-scale multi-center randomized controlled trial.

Following informed consent, patients will be randomized to receive 10 days of cephalexin or PDAD (minimum of 3 days of cephalexin followed by placebo once patient reports 24 hours of symptom resolution). Patients will be evaluated at day 1 in-person, then daily using a mobile cellphone application to assess acute uncomplicated pyelonephritis (AUP) symptoms and quality of life (QOL). Urine samples will be collected at in-person visits at day 1, 3 weeks, and 4 weeks. Study feasibility will be assessed through day 90.

Eligibility Criteria:
Inclusion:

* Females between 18 and 55 years of age
* Diagnosis of acute uncomplicated pyelonephritis
* Can be discharged home on oral antimicrobial treatment
* Ability to provide written informed consent in English or Spanish

Exclusion:

* Took antibiotics in the prior 48 hours
* Insulin-dependent diabetes
* End-stage liver disease
* If the patient reports a penicillin allergy, and is deemed to be high-risk using the penicillin allergy clinical decision rule (PEN-FAST)
* Serious allergy (e.g., angioedema, anaphylaxis) to the study medication or a similarly reported allergy to a cephalosporin
* Known or identified hydronephrosis, obstruction, or abscess identified by emergency department ultrasound
* Presence of a kidney stone
* Pregnancy or lactation
* Renal dysfunction (defined as creatinine clearance of less than 30 mL/min)
* Renal transplantation
* Complicated pyelonephritis (defined anatomical or functional abnormality of the urinary tract that predisposes to infection)
* Need for additional antimicrobial therapy for a coexisting infection
* Human immunodeficiency virus (HIV) infection, with either a recent (in the past 6 months) acquired immune deficiency syndrome-defining condition or a cluster of differentiation-4 (CD-4+) T lymphocyte count \<200/mm\^3
Impact of Daily, Digital and Behavioral Tele-health Tapering Program for Perioperative Surgical Patients Exposed to Opioids and Benzodiazepines.

The purpose of this study is to examine the safety, acceptability, and feasibility of a controlled taper off of opioids and/or benzodiazepines, with the use of behavioral health tele-health based therapy services, in the perioperative patient.


Eligibility Criteria:
Inclusion Criteria:

* Preoperative benzodiazepines opioid dependence (daily use of opioids or benzodiazepines preoperatively) (Naive: No Meds 30 Days Prior to surgery,Opioid tolerant/dependant: Use of Meds on Most Days For 1 or more months prior to surgery)
* Subject willing to use Lucid Lane program to provide behavioral health support perioperative period up to 6 months post-op for tolerant opioid/benzo users
* Subject is willing to discuss Lucid Lane progress with the University of Texas Health Science Center(UTHealth) perioperative team and prescribing clinicians
* Subject is willing to sign a Lucid Lane Client Agreement
* Willing to sign an informed consent

Exclusion Criteria:

* Serious mental illnesses including schizophrenia-spectrum disorders, severe bipolar disorder, and severe major depression.
* Active suicidal ideations
* Patients on methadone or buprenorphine for treatment of opioid use disorder (i.e. for treatment of addiction, and not for treatment of pain)
* Patient unwilling to use or not possessing access to a device that allows for video visits (e.g. a smartphone, tablet, or computer)
* Patients who are on palliative care
* Insufficient ability to use English to participate in the consent process, the intervention or study assessments.
* Insufficient ability to provide informed consent to participate
* If the patient misses more than 2 lucid lane sessions per week, the staff will be immediately notified by Lucid Lane.
Opioid Prescribing in the Emergency Department for Sickle Cell Disease

This study consists of a clinical vignette presented to emergency physicians asking them what they would prescribe to a patient with acute abdominal pain.


Eligibility Criteria:
Inclusion Criteria:

* Being a emergency physician

Exclusion Criteria:

* Working outside of Europe.
Natural History of Lung Nodules Seen on CT Scans From Participants at High-Risk of Developing Lung Cancer

RATIONALE: Comparing lung CT scans from participants with lung nodules at high-risk for lung cancer may help doctors learn more about the disease and find better methods of treatment.

PURPOSE: This trial studies the natural history of lung nodules using CT scans from participants at high-risk for lung cancer.

OBJECTIVES:

Primary

* Evaluation of lung nodules (target and non-target lesions) detected during annual low-dose (ld) computed tomography (CT) scans and measured for three years after study completion in subjects enrolled in a randomized, phase IIb, placebo-controlled trial with inhaled budesonide (both person-specific and lesion-specific analyses will be performed).

Secondary

* Lung cancer detection rate in the two arms.
* Appearance of new nodules in the two arms.

OUTLINE: Low-dose CT scans are analyzed retrospectively for the natural progression of undetermined lung nodules. Nodule dimension will be evaluated according to maximum diameter and volume, when feasible. Volume measurements are performed using an automatic and semi-automatic computer-aided diagnosis (CAD) system. Lesion-specific and person-specific analysis are performed by measure of average change in size of the target lesions or number of lesions.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Annual Computed Tomography (CT) scans obtained from participants with undetermined lung nodules detected by low-dose CT enrolled in both of the following trials:

  * A large-scale COSMOS screening trial

    * Three annual CT scans obtained as part of the COSMOS trial after budesonide study treatment completion
  * The MDA05-5-01, a subset of COSMOS trial participants, a randomized phase II trial of inhaled budesonide twice daily versus placebo

    * Two CT scans performed as part of the budesonide protocol (MDA05-5-01)
* Only CT scans from participants enrolled in both trials will be used

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Efficacy and Safety of Lumiracoxib in Patients With Primary Knee Osteoarthritis (OA)

This 39-week, active controlled, study is designed to assess long-term efficacy, safety and tolerability of lumiracoxib 100mg od in patients with osteoarthritis (OA) of the knee who participated in the 13-week core CCOX189A2361 study.


Eligibility Criteria:
Inclusion Criteria:

* Any patient who completed the core study 2361 may enter the extension trial upon signing informed consent. A patient is defined as completing if he/she completed the core study 2361 up to and including Visit 6 (week 13) without a major protocol violation.

Exclusion Criteria:

* Those patients for whom continued treatment in the extension study is not considered appropriate by the treating physician
* Those patients who were non-compliant or who demonstrated a major protocol violation in the core study.

Other protocol-defined inclusion/exclusion criteria may apply
Evaluation of Quality of Life (QoL) in Subjects With Highly Active Relapsing Multiple Sclerosis (MS) (CLARIFY MS)

The main purpose of the study was to assess the health-related quality of life (HRQoL) through the Multiple Sclerosis Quality of Life-54 Questionnaire (MSQoL-54) scale in highly-active relapsing multiple sclerosis (RMS) particpants treated with Mavenclad® for 2 years (24 months).


Eligibility Criteria:
Inclusion Criteria:

* Highly active RMS as defined by:
* One relapse in the previous year and at least 1 T1 Gadolinium (Gd)+ lesion or 9 or more T2 lesions, while on therapy with other disease modifying drugs (DMDs).
* Two or more relapses in the previous year, whether on DMD treatment or not.
* Expanded Disability Status Scale (EDSS) score less than equals to (\<=) 5.0.
* Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

* Positive hepatitis C or hepatitis B surface antigen test and/or core antibody test for immunoglobulin G (IgG) and/or immunoglobulin M (IgM).
* Current or previous history of immune deficiency disorders including a positive human immunodeficiency virus (HIV) result.
* Currently receiving immunosuppressive or myelosuppressive therapy with, for example, monoclonal antibodies, methotrexate, cyclophosphamide, cyclosporine or azathioprine, or chronic use of corticosteroids.
* History of tuberculosis, presence of active tuberculosis, or latent tuberculosis
* Presence of Progressive Multifocal Leukoencephalopathy (PML) in Magnetic Resonance Imaging (MRI).
* Active malignancy.
* Other protocol defined exclusion criteria could apply.
Lasers in Onychomycosis

Onychomycosis is the most common nail disease, representing more than 50% of all onychopathies. Future studies on the absorption spectra of dermatophyte fungi will be needed to develop lasers that effectively exploit absorption differences in fungi and dermal tissue.

Treatments with antifungals may not be successful due to several factors, including the long time required to apply topical medications, the side effects of systemic drugs, and the application of insufficient medication to the target area. Even with adequate systemic or topical therapy, the persistence of fungal infections is not uncommon. In light of these limitations, laser therapy has been proposed as an alternative option for onychomycosis therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with onychomycosis.

Exclusion Criteria:

* Patients with excessive manual work
Potential Benefits of Sleeve Gastrectomy Surgery on Diabetic Gastroparesis Symptoms

The purpose of this registry is to evaluate if sleeve gastrectomy surgery will help with symptoms of delayed gastric emptying for patients suffering from diabetic gastroparesis.

This is a prospective registry enrolling patients with an established diagnosis of diabetic gastroparesis and interested in receiving a sleeve gastrectomy for weight loss. An often intentional outcome of sleeve gastrectomy is an increase in gastric emptying. The relationship between how beneficial this outcome could be for diabetic gastroparesis patients suffering from delayed gastric emptying is not very well established. The purpose of this study is to find out if sleeve gastrectomy surgery will also help with symptoms of delayed gastric emptying. This study involves completing the Gastroparesis Cardinal Symptom Index questionnaire before your weight loss surgery and after surgery at the following time points; 30 days, 3 months, 6 months, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and above
* BMI \> 35
* Diagnosis of diabetic gastroparesis as confirmed via scintigraphy
* Subject opting to undergo sleeve gastrectomy

Exclusion Criteria:

- Any previous weight loss surgery or prior gastrectomies