cyrilzakka/clinical-trials huggingface dataset:
Vascular Reparative Mechanism in Diabetes

The purpose of this research study is to study blood stem cells in diabetic patients and normal patients. We would like to better understand if these cells, called endothelial precursor cells (EPCs), are not working as expected in people with diabetes. We would like to see if the function of these cells can predict the development of diabetic retinopathy.

Diabetic retinopathy is an eye disease associated with diabetes in which the cells of the retina are damaged. It can cause blurred vision, vision loss, blindness or possible bleeding in the retina. Even with current treatments, the quality of life for people with diabetic retinopathy is much reduced.


Eligibility Criteria:
Inclusion Criteria:

* Men or women 18 years or older
* 39 type 1 or type 2 diabetic patients
* 13 with mild retinopathy
* 13 with moderate retinopathy
* 13 with severe, nonproliferative retinopathy
* 39 age and sex matched healthy controls

Exclusion Criteria:

* Current pregnancy as evidence by a urine pregnancy test as the blood from a pregnant female will influence the results of the laboratory tests
Lidocaine Infusion for Propofol Dose Reduction in ERCP Procedure

This study aims to investigate the dose reduction of propofol if associated with continuous infusion of lidocaine during ERCP procedures in patients over 65 years old.

The primary aim of this study was to evaluate the effect of continuous infusion of lidocaine on propofol consumption in older patients having ERCP sedation. Secondary outcomes were to evaluate patient adverse events, sedation quality and satisfaction of the patient and the endoscopist, postprocedural pain, and sedation-related time.For this the investigators randomised patients into 2 groups: Group Lidocaine received 1,5 mg/kg lidocaine 1% 10 min before procedure and then 2 mg/kg/h continuous infusion of lidocaine 1%, whereas the Group Control received an equal volume of saline solution, which could not be visually identified from lidocaine by the blinded anaesthesiologist. All patients received propofol bolus dose of 1mg/kg than 10-20 mg iv boluses during the procedure guided by capnograph monitoring and the patient's grimace, mobility, hemodynamic changes.

Eligibility Criteria:
Inclusion Criteria:

* 65-85 years old
* physical status ASA I, II, III,
* ERCP scheduled

Exclusion Criteria:

* ASA IV or higher
* severe renal, cardiac or liver failure,
* allergy to lidocaine,
* patients weighing less than 40 kg,
* inability to give informed consent
Subjective Well Being of Schizophrenic Patients in Greece

Non-interventional study aiming to provide data on the subjective effects of antipsychotic medication assessing subjective well-being and global functioning of patients with Schizophrenia under antipsychotic medication. Moreover it aims to assess their adherence to the treatment and will investigate whether there is any correlation of these factors with the clinical condition of these patients.


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent
* Diagnosis of schizophrenia according to DSM-IV
* The patient must have been prescribed an atypical antipsychotic for at least 4 weeks before the first study visit

Exclusion Criteria:

-
Community-based Microalbuminuria Screening in Patients With Hypertension

This study evaluates the effectiveness of different anti-hypertensive drugs on patients with hypertension and microalbuminuria.

This is a a real world registry study. All patients with hypertension in community hospitals in China will be eligible . Patient demographics, medical history, clinical characteristics, physical examination, laboratory tests (including UCAR, blood routine, urine routine, blood biochemistry, and ECG), antihypertensive drugs (including: ACEI/ ARB, thiazide diuretics, CCB, beta-blockers, alpha-blockers, and other antihypertensive drugs used in real-life clinical practice in other communities.) will be recorded. All patients are anticipated to be followed up for 12-month. Effectiveness of different antihypertensive medications on Urine Albumin-to-Creatinine Ratio (UACR) will be evaluted.

Eligibility Criteria:
Inclusion Criteria:

* Patients with essential hypertension;
* Urinary albumin/creatinine ratio in random urine samples is 30-300 mg/g
* Age \>=18
* Understand and sign informed consent

Exclusion Criteria:

* This is a real-world registry study and does not set exclusion criteria
Accuracy of the Dexcom G7 Continuous Glucose Monitoring System Following Cardiac Surgery

This is a prospective longitudinal study to study the agreement between a continuous glucose monitoring system (CGMS) versus current blood glucose monitoring. Subjects in this study will have their blood glucose measured regularly every 1-3 hours with current methods in the Cardiovascular Intensive Care Unit (CVICU), and by Point of Care (POC) fingerstick glucose using the Accucheck Inform II on the regular floors, and the CGMS reading at the same time will be captured. Subjects will have measurements taken throughout their stay in the CVICU and on the regular floors. Agreement and correlation between systems, as well as errors, will be calculated.

The Dexcom G7 will be placed either by an anesthesiologist or nurse anesthetist, or critical care physician, nurse or nurse manager upon arrival to CVICU, post cardiac surgery.

Standard of care:

Accuchek will be done per standard of care for post operative patients that are in ICU

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years old and above
* Planned cardiothoracic surgery
* Planned admission to Cleveland Clinic Main Campus building J5 or J6 or Q5 cardiovascular intensive care unit (CVICU) followed by transfer to the step down unit
* With or without known diabetes (as 75% of patients entering the CVICU have hyperglycemia requiring intravenous insulin infusion)
* If with known diagnosis of diabetes, diabetes can be type 1, type 2, or secondary (such as due to glucocorticoids or pancreatitis

Exclusion Criteria:

* Allergy to the material of the continuous glucose monitoring systems (CGMS) or the adhesive to be used
* Skin conditions precluding the use of the CGMS
* Pregnancy
* Other conditions that the investigators deem inappropriate for the study
* Patients receiving mechanical circulatory assist devices
Mirror Therapy Integrated with Electrical Stimulation for Cortical Modulations

Peripheral nerve injury is common and can result in loss of sensation and motor function, reduced quality of life, and prolonged time to return to work. Maladaptive cortical reorganization occurs after nerve injury or immobilization and can further impair the recovery process. To improve the sensorimotor prognosis of people with peripheral nerve injury, methods such as mirror therapy, motor imagery, and electrical stimulation have been used in addition to usual care. However, no studies have shown the effect of integrating mirror therapy, motor imagery, and electrical stimulation in these individuals. Furthermore, the real-time effect of mirror therapy on cortical activation in this population remains unexplored. This study aims to determine the real-time cortical modulation effects of mirror therapy combined with electrical stimulation in individuals with peripheral nerve injury.

Two groups of subjects (a group of peripheral nerve injury group and a group of healthy adults) will perform hand exercises in three randomized conditions: (1) mirror therapy with electrical stimulation and motor imagery, (2) electrical stimulation and motor imagery, and (3) motor imagery. Each participant performs specific sets of two exercises based on the type of nerve injury: (1) Median nerve injury: Picking up and putting down a pen using the thumb and index finger, and picking up and putting down a marble using the thumb and little finger. (2) Ulnar nerve injury: Picking up and putting down a card using the thumb and index finger, and picking up and putting down a marble using the thumb and little finger.(3) Brachial plexus injury: Picking up and putting down an empty cup, and picking up and putting down a pair of pliers. For combined median nerve and ulnar nerve injuries and healthy adult groups, movements corresponding to median nerve injuries are performed. Each experimental condition consists of 20 repetitions, lasting 60 seconds, followed by a 30-second rest between conditions. Relative alpha and beta band power in the sensorimotor cortex will be recorded and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed median or ulnar nerve transection injury of the forearm in the past 6 months
* sufficient communication in the Chinese language
* being able to follow instructions
* muscle atrophy or lack of voluntary contraction over the injured hand, with maximum voluntary isometric contraction (MVIC) recorded with surface electromyography (EMG) less than 10% compared to the non-affected hand
* achieve an average score of 2 or above in the Kinesthetic and Visual Imagery Questionnaire-10 (KVIQ-10) for kinesthetic imagery

Exclusion Criteria:

* had central nervous disease
* had a recent (1 year) history of nerve entrapment syndrome
* had a history of latent neuropathy, such as diabetes or dialysis
The Aortic Surgery Cerebral Protection Evaluation (ACE) Randomized CardioLink-3 Trial

The ACE trial is a multicentre, randomized controlled trial comparing axillary vs. innominate artery cannulation for established antegrade cerebral perfusion in patients having aortic surgery (thoracic and aortic arch) requiring deep hypothermic circulatory arrest using a non-inferiority trial design.

Surgery on the thoracic aorta often requires a brief period of deep hypothermic circulatory arrest (DHCA). The most feared complication of aortic surgery is neurological injury, which can range from mild cognitive impairment to more severe injuries such as stroke. Due to the significant morbidity and mortality associated with post-operative stroke and neurological dysfunction, cerebral protection techniques have evolved extensively. A recommended approach to cerebral protection during DHCA is to deliver blood to the brain in an antegrade fashion via the arterial system, so called antegrade cerebral perfusion (ACP). Axillary artery cannulation, a form of ACP, has become the preferred method of neuroprotection for aortic operations requiring DHCA. However, axillary artery cannulation requires more surgical time and presents potential complications such as brachial plexus injury, seromas, and limb ischemia. The present study aims to determine whether a less common alternative strategy, innominate artery cannulation, offers similar neuroprotection compared to axillary artery cannulation and reduces operative times. A total of 110 patients undergoing elective aortic surgery will be randomly assigned to one of the two strategies. The primary outcome will be the number of patients with new ischemic lesions found on post-operative diffusion weighted MRI (DW-MRI) and total operative time.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Elective aortic arch operation.
3. Planned open distal anastamosis with deep hypothermic circulatory arrest.

Exclusion Criteria:

1. Patients undergoing surgery for aortic dissection or urgent/emergent operation.
2. Patients undergoing surgery for total aortic arch replacement.
3. Patients who are unable to undergo MRI scan (such as due to claustrophobia).
4. Use of an investigational drug or device at the time of enrolment
5. Participation in another clinical trial which interferes with performance of the study procedures or assessment of the outcomes
Loneliness Group Intervention

The goal of this pilot study is to determine the feasibility and acceptability of a group loneliness intervention in geriatric psychiatry inpatients. This type of group loneliness intervention is based on functional analytic psychotherapy and is called Awareness, Courage, and Love Groups.

The objective of our clinical trial is to adapt, implement, and evaluate a type of loneliness group intervention called Awareness, Courage, and Love Groups for older adults in a psychiatric unit. The following research questions will be answered: (a) Are ACL groups with geriatric psychiatry inpatients feasible and acceptable? (b) Do such ACL groups demonstrate preliminary efficacy?

Eligibility Criteria:
Inclusion Criteria:

* Admission to geriatric psychiatry inpatient unit

Exclusion Criteria:

* Individuals who are disoriented to person, delirious, unable to tolerate or participate meaningfully in the group, or otherwise unable to provide consent to research and psychotherapy
Combination Chemotherapy Followed by Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with irinotecan and cisplatin followed by surgery in treating patients with stage IIIA non-small cell lung cancer.

OBJECTIVES:

* Evaluate the efficacy of irinotecan based chemotherapy in patients with stage IIIA non-small cell lung cancer.
* Investigate the phenotypic changes induced in the tumor by this treatment.

OUTLINE: Patients receive IV cisplatin over 30 minutes followed by IV irinotecan over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for 3 courses until disease progression. Once potential candidates for resectability are determined, patients undergo thoracotomy or concurrent chemotherapy/radiation therapy within 6 weeks of completing the last course of chemotherapy. Following resection, patients responding to chemotherapy receive 3 additional courses of IV carboplatin and paclitaxel over 3 hours. Patients may undergo local irradiation beginning with the second course of carboplatin and paclitaxel. Chemotherapy ceases if disease remains stable after 8 weeks.

Patients are followed every 3 months for the first year after treatment, then every 6 months thereafter for survival.

PROJECTED ACCRUAL: This study will accrue 20 patients over 18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed, previously untreated stage IIIa (T1-2 N2 M0) non-small cell lung cancer

PATIENT CHARACTERISTICS:

Age:

* Over 18

Performance status:

* ECOG 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Total bilirubin no greater than 1.5 mg/dL

Renal:

* Creatinine clearance at least 55 mL/min

Other:

* Not HIV positive
* No active infections
* Not pregnant or lactating
* Effective contraception required of fertile patients during study participation
* No coexisting medical condition

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy
* No concurrent chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* No prior radiation therapy
* No concurrent radiation therapy

Surgery:

* Not specified

Other:

* No concurrent use of investigational agents during study participation
Development and Validation of in Vitro Cell-based Bioassays for Nuclear Receptor Activation

This is a prospective biobank set up to collect serum from patients with disorders associated with changes in androgens, estrogens or sex hormone-binding globulin (SHBG), before and/or after treatment.

In vitro cell-based bioassays may be a technique to measure serum androgen or estrogen bioactivity. In this study investigators are collecting serum (and if possible, urine) samples from different cohorts of patients, before and/or after treatment.

The aim is to measure androgens, estrogens and SHBG as well as in vitro bioactivity with newly developed cell-based bioassays, and to compare different techniques to each other as well as to clinical endpoints available in the patient's Electronic Health Record.

Eligibility Criteria:
Inclusion Criteria:

* Known or expected medical condition affecting androgens, estrogens or SHBG

Exclusion Criteria:

* Inability to provide written informed consent
* Known or suspected bloodborne infectious diseases (e.g. HIV, viral hepatitis etc.)
* Anemia (\<11 g/dL hemoglobin) or being a Jehovah's Witness
Evaluation of the Consumption of Lupins in Brine on Metabolic Markers in Healthy Individuals

The aim of the project was the evaluation of the effects of the consumption of different amounts of lupins in brine on lipid, glucose, inflammatory, oxidative stress, gut microbiota profile and (epi)genetic markers in healthy volunteers, by means of a 4-week 2-arm parallel randomized controlled trial.

Epidemiological and intervention studies confirm a tight relationship between lifestyle - and particularly dietary choices - and human health. Among the dietary patterns, it has been showed that the adherence to a plant-based diet, i.e. Mediterranean diet, may have a pivotal role in promoting a health longevity and counteracting cardiovascular, neurological and cancer-related diseases. In fact, the abundant consumption of fruit, vegetables, cereals and pulses leads to a high intake of vegetable proteins, unsaturated fatty acids, minerals, vitamins, fibre and bioactive compounds which may have anti-inflammatory, antioxidant, anti-atherosclerotic, hypocholesterolemic and antimicrobial activities. In particular, there is a growing interest for valorization of pulses, among which lupins represent a good alternative as healthy snack but also as serving to be used during the principal meal. Lupins are traditional legumes of the Mediterranean basin, and they represent a good source of bioactive peptides, soluble fibre and minerals. Different trials evaluated the health effects of the consumption lupin derived products in humans concluding that it may lead to a decrease of blood pressure, reduction of blood glucose, cholesterol, triglycerides and uric acid.

Nevertheless, there is still a lack of information regarding the effects of the consumption of whole lupins, and in particular in one of the most sold forms, as in brine.

In this parallel randomized controlled trial, 60 healthy volunteers were randomly allocated for a 4-week consumption of:

* Active comparator arm: 30 grams per week of lupins in brine;
* Experimental arm: 600 grams per week of lupins in brine and the suggestion of reduction of at least two servings per week of meat, processed meat and/or cheese;

At baseline and after 4 weeks of dietary intervention, subjects were visited in medical facility and asked to provide blood, urine, saliva, feces for the evaluation of:

* Anthropometric and blood pressure parameters;
* Blood lipid and carbohydrate profile;
* Blood transaminase parameters;
* Blood and urine inflammation markers;
* Leucocyte and saliva DNA genetic and epigenetic markers;
* Fecal profile of gut microbiota. In addition, volunteers filled in different questionnaires regarding their dietary habits, the physical activity and the gut healthiness.

Eligibility Criteria:
Inclusion Criteria:

* BMI included between 18.5 and 29.9 kg/m2;
* Omnivorous diet;
* Consumption of more than 6 servings of meat, processed meat and/or cheese;

Exclusion Criteria:

* Antibiotic treatment within 3 months prior the dietary intervention;
* Chronic diseases
* Surgeries
* Dieting
* Pregnant or lactating
Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HSD-016

This is a single ascending dose study of HSD-016 to provide the initial assessment of the safety, tolerability, how the drug is absorbed and eliminated, and its effect on the body.


Eligibility Criteria:
Inclusion:

1. Men or women of nonchildbearing potential aged 18 to 50 years inclusive at screening.
2. Healthy as determined by the investigator on the basis of screening evaluations.
3. Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history.

Exclusion:

1. No presence or history of any disorder that may prevent the successful completion of the study.
2. No history of drug abuse within 1 year.
Treatment, Emotion, and Neuromodulation of Depression (TREND) Study

The investigators will administer theta burst stimulation (TBS) in efforts to observe a decrease in severity of reported depression symptoms. A subset of participants will receive positive affect training during this intervention.

The study has a longitudinal design in which participants complete a baseline assessment, 20 theta burst stimulation (TBS) sessions, a post-TBS assessment, and a follow-up assessment 4 months later. Ideally, TBS sessions will be delivered twice/day, 5 days/week, for 2 weeks. This procedural design of a shorter treatment duration is based on findings of pattern of improvement and newly developed SAINT protocol. A subset of participants will receive training in enhancing positive affect, with 10 training sessions occurring between pairs of TBS sessions. In this study, "response" to intervention will be defined as a greater than 50% decrease in severity of depression symptoms reported by participants.

Eligibility Criteria:
Inclusion Criteria:

* Current Diagnostic and Statistical Manual (DSM-5) Depressive Disorder

Exclusion Criteria:

* Bipolar disorder (lifetime)
* Obsessive-compulsive disorder (lifetime)
* History of psychosis
* Daily use of nicotine
* Past-month use of cocaine, amphetamines, Methyl enedioxy methamphetamine (MDMA), Phencyclidine (PCP), Ketamine, or gamma-hydroxybutyrate (GHB)
* Past 6 month substance use disorder
* Binge drinking (using NIAAA criteria) within the past week, alcohol use in the past 12 hours
* Neurological disorders: Epilepsy, Parkinson's Disease, brain tumor, brain injury, stroke
* History of head trauma with a loss of consciousness (e.g., concussion)
* History of seizures
* MRI contraindications: body shape/size too large to fit in scanner, claustrophobia, and ferromagnetic metal in the body
* Pregnancy
* Current use of Clozapine, Bupropion, or prescription stimulants
* Current use of benzodiazepines or mood stabilizers
* Body shape/size too large to fit in MRI scanner
* Claustrophobia
* Metal in the head or ferromagnetic metal in the rest of the body
* Implanted medical devices
* High-risk suicidality
Evaluation of an Absorbable Implant for the Treatment of Nasal Valve Collapse

To evaluate the safety and feasibility of the INEX Nasal Implant in subjects with moderate to severe nasal valve collapse.

This study is a multicenter, nonrandomized, prospective exploratory study of the INEX Nasal Implant. The purpose of this study is to evaluate the safety and feasibility of the INEX Nasal Implant in subjects with moderate to severe nasal valve collapse.

Eligibility Criteria:
Eligible participants are:

1. Adult patients seeking treatment for nasal obstruction on one or both sides of the nose who are willing to undergo an office-based or intraoperative nasal implant procedure in lieu of alternative treatments (ie, surgical repair or use of an external dilator).
2. Nasal valve collapse (NVC) must be a primary or significant contributor to the subject's nasal obstruction based on clinical presentation, physical examination and nasal endoscopy.
3. Baseline Nasal Obstruction Symptom Evaluation (NOSE) score must be ≥55.

Participants are excluded for the following:

1. Surgical or non-surgical treatment of the nasal valve or rhinoplasty within 12 months before enrollment.
2. Septoplasty, inferior turbinate reduction, or other surgical nasal procedures within 6 months before enrollment.
3. Recurrent nasal infections.
4. Use of intranasal steroids within 2 weeks preimplant and 2 weeks post implantation.
5. Presence of a permanent implant, dilator, or uses an external device in the nasal area.
6. Cancerous or precancerous lesions and/or radiation exposure in the treatment area or chemotherapy within 24 months of the study.
7. Significant bleeding disorders.
8. Significant systemic diseases.
9. Currently using nasal oxygen or continuous positive airway pressure (CPAP).