cyrilzakka/clinical-trials huggingface dataset:
Contingency Management for Smoking Cessation Among Veterans With Psychotic Disorders

This study examines the use of contingent incentives to increase attendance at smoking cessation treatment sessions by smokers with schizophrenia and other psychoses who want to quit smoking. We hypothesize that participants randomized to receive contingent rewards for group attendance will attend more treatment sessions than those in the control group.

Schizophrenia and other psychotic disorders are highly prevalent in the VA population and are associated with high rates of smoking. Although smoking cessations approaches that work for non-schizophrenic patients such as behavioral counseling and medications appear to be efficacious for schizophrenic smokers, a major obstacle in providing adequate treatment is poor attendance at treatment sessions. Contingency management has been shown to shape treatment behavior in non-schizophrenic smokers and to shape other behaviors such as cocaine use and exercise in schizophrenics.

The intention of this project is to examine the use of contingent incentives to increase attendance at smoking cessation treatment sessions by smokers with schizophrenia and other psychoses and to compare two different approaches to providing contingent incentives in this context. Subjects in the experimental condition draw from a fishbowl to obtain tokens when they attend a smoking cessation treatment session. The number of draws will be based upon attendance at consecutive sessions. Subjects in the experimental condition receive a set reward that will not change regardless of attendance at consecutive sessions. We hypothesize that the participants in the experimental condition will attend more smoking cessation group therapy sessions than those in the control condition because they will have the possibility, although not the likelihood, to obtain contingent reinforcement of greater value.

Eligibility Criteria:
Inclusion Criteria:

* All subjects must be diagnosed with schizophrenia or any other psychotic disorder, bipolar disorder with psychotic features, or major depression with psychotic features according to the electronic medical record.
* Current nicotine use, defined as smoking 5 or more cigarettes/day for at least 16 of the past 30 days prior to study screening.
* Prospective subjects must indicate willingness to attend smoking cessation group therapy.

Exclusion Criteria:

* Imminent risk for suicide or violence.
* Severe psychiatric symptoms or psychosocial instability likely to prevent participation in the study protocol (i.e., attendance at scheduled sessions, ability to read study materials, and/or ability to comprehend interventions).
* Clinically apparent, gross cognitive impairment.
Evaluation of a Hybrid Prototype Strategy (Electrostimulation of Lower Limb Muscles Associated With Voluntary Strengthening of the Upper Limbs) in Reconditioning to Effort in Patients With Chronic Paraplegia.

This single-centre study was carried out in collaboration with the Cardiovascular Research Laboratory of Harvard University (Boston, USA). This preliminary study does not include a control group.

The aim of this study was to investigate the effect of a hybrid reconditioning programme (electrostimulation of the lower limb muscles associated with voluntary strengthening of the upper limbs) on a specially developed rowing machine in patients presenting stabilized paraplegia of a traumatic origin. This study will bear on the increase in maximal aerobic capacity (VO2max) between the start and end of the 9-month reconditioning programme.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with paraplegia, ageb between 18 and 45 years
* Body mass index (BMI) between 18.5 and 29.9
* 2 to 15 years after the accident, ASIA A or B, lesion situated between T3 and T12
* Medically stable
* Able to follow instructions
* Persons who have provided written informed consent

Exclusion Criteria:

* Persons without national health insurance cover
* Arterial blood pressure \> 140/90 mmHg, arrythmia, heart disease, diabetes, impaired kidney function, cancer
* smoking-induced intoxication,
* Medical treatment for cardiovascular disease or antidepressants
* Orthostatic hypotension with a symptomatic fall in arterial pressure \> 30 mmHg in the vertical position
* Grade 2 or more pressure sores
* Other associated neurological diseases (e.g. cerebrovascular accident, peripheral neuropathy, myopathy)
* Any disease affecting the shoulder that may compromise the ability to use the rowing machine.
* Coagulation disorders;
* Presence of an implanted electronic device
* Epilepsy
Optic Nerve Head Autoregulation During Changes in Arterial Blood Pressure

Constant despite changes in perfusion pressure. It is observed in many vascular beds of the human body to prevent that variations in perfusion pressure are directly transmitted into changes in blood flow. This is necessary to prevent ischemia and/or hypoxia during decreased blood flow and bleeding or increased capillary pressure during increased blood flow.

In the eye, several studies have reported that retinal blood flow is autoregulated over a wide range of ocular perfusion pressures. Unfortunately only few data are available for the optic nerve head. To gain data about autoregulation is of special importance given that several important ocular diseases such as glaucoma and age-related macular degeneration are associated with impaired autoregulation. In humans most data were collected using laser Doppler flowmetry.

The present study aims to investigate the phenomenon of transient reduction in blood flow and to gain insight in the regulatory mechanisms of optic nerve head blood flow during isometric exercise.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 18 and 35 years, nonsmokers
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropia less than 3 diopters

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug (except oral contraceptives)
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Blood donation during the previous 3 weeks
Efficacy and Safety of Vildagliptin Compared to Placebo on the Incretin Effect in Patients With Type 2 Diabetes Treated With Metformin

This mechanistic study will evaluate the effect of vildagliptin on glucose-stimulated insulin secretion to improve the incretin effect in patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes on metformin for at least 3 months and have been on a stable dose of at least 1500 mg daily for a minimum of 4 weeks
* Agreement to maintain the same dose of metformin throughout the study
* Body mass index (BMI) in the range of 22-35 kg/m2
* HbA1c in the range of 7.0 to 9.0%
* FPG \<200 mg/dl (11.1 mmol/L)
* Agreement to maintain prior diet and exercise habits during the full course of the study
* Ability to comply with all study requirements and signed informed consent to participate in the study

Exclusion Criteria:

* A history of type 1 diabetes
* A history of acute metabolic diabetic complications
* Evidence of significant diabetic complications
* Insulin treatment for longer than 10 days within the past 6 months
* Treatment with any oral anti-diabetic other than metformin within 3 months prior to visit 1

Other protocol-defined inclusion/exclusion criteria may apply
Evaluating the Analytical Equivalency of Serum and Whole Blood Samples Run on the MeMed Key® Platform (Perseverance Study)

This is a Prospective, multi-center, sample collection study enrolling pediatric and adult subjects presented to the ED/Urgent care, with symptoms consistent with acute bacterial or viral infection will be recruited according to eligibility criteria. The study is designed to measure the MeMed BV®️ score in whole blood and serum samples and demonstrate the equivalence between the two matrices. Patients will be managed according to the current standard of care per standard institutional procedures.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent must be obtained from the patient or his/her legal guardian. For children under 18 years old, written informed consent from the legal guardian must be obtained and assent from the patient may be required depending on the local requirements.
2. Over 90 days of age.
3. Clinical suspicion of acute bacterial or viral infection.
4. Symptoms of acute infectious disease \< 7 days.
5. Experienced fever at least once within the last 7 days (self-reported or Temperature ≥ 37.8°C (100°F)).

Exclusion Criteria:

1. HIV, HBV, active HCV, or active Tuberculosis infection (self-declared or known from medical records).
2. Suspicion and/or confirmed diagnosis of infectious gastroenteritis/ colitis.
3. Active inflammatory disease (e.g., IBD, SLE, JIA, RA, Kawasaki, other vasculitis).
4. Pregnancy- self reported or medically confirmed.
5. Active malignancy.
6. Congenital or acquired immune deficiency (CID).
7. A proven or suspected infection on presentation with Mycobacterial (e.g., Tuberculosis, MAC), parasitic or fungal (e.g., Candida, Histoplasma, Aspergillus) pathogen.
8. Significant trauma or burns in the last 7 days.
9. Patients that have undergone major surgery in the last 7 days.
10. Current treatment with immune-suppressive or immune-modulating therapies, including without limitations:

    1. Administration of P.O.\\IV\\IM high dose steroids \>1mg/kg/day prednisone (or equivalent) at some point in the past 10 days or daily continuous use of steroids \> 0.25 mg/kg/day in the past 7 days
    2. Monoclonal antibodies, anti-TNF agents
    3. Intravenous immunoglobulin (IVIG)
    4. Cyclosporine, Cyclophosphamide, Tacrolimus, Azathioprine, Methotrexate
    5. G/GM-CSF, Interferons.
A Study To Find The Best Dose Of SU011248 When Given With Pemetrexed, Pemetrexed And Cisplatin Or Pemetrexed And Carboplatin In Patients With Advanced Solid Tumors

This study will assess the maximum tolerated dose, overall safety and antitumor activity of SU011248 in combination with pemetrexed, pemetrexed and cisplatin or pemetrexed and carboplatin in patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of a solid cancer which is not responsive to standard therapy or for which no standard therapy exists.
* Patient has a good performance status (ECOG 0 or 1).

Exclusion Criteria:

* Prior treatment with either pemetrexed or SU011248.
* Coughing up blood within 4 weeks before starting study treatment (small amounts okay).
* Hypertension that cannot be controlled by medications.
Study of OZURDEX® in the Treatment of Diabetic Macular Oedema (DME) in Australia - The AUSSIEDEX Study

This prospective study will assess Ozurdex in the treatment of Diabetic Macular Oedema in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Pseudophakic or phakic and scheduled for a cataract operation
* Macular oedema due to DME

Exclusion Criteria:

* Previous Ozurdex® treatment
A Comparison Between Ivor-Lewis and McKeown Minimally Invasive Esophagectomy

Surgery is still the main treatment for esophageal cancer, however, the complication and mortality rate of open esophagectomy is high. As a result, the thoracoscopic- laparoscopic minimally invasive esophagectomy (MIE) was developed. The MIE mainly comprised two surgical approaches:

MIE McKeown approach (cervical anastomosis) and MIE Ivor-Lewis approach (intrathoracicanastomosis). The MIE with intrathoracic anastomosis (Ivor-Lewis) is increasingly used for the treatment of mid and lower esophageal cancers. Our study is trying to compare the safety, feasibility, and short-term and long- term outcomes between MIE Ivor-Lewis approach and MIE McKeown approach for the treatment of lower thoracic esophageal cancer and esophageal- gastric junction.


Eligibility Criteria:
Inclusion Criteria:

(I) Patients with clinically staged T1-3N0-2M0 tumors; good cardiopulmonary function;

(II) Patients with lower thoracic esophageal tumors and esophageal- gastric junction tumor;

(III) Patients without a previous history of cancer;

(IV) Patients without a previous history of neck or chest surgery;

Exclusion Criteria:

(I) cardiopulmonary function not good enough for surgery;

(II) Patients with hybrid MIE
Evaluation of a Topical Treatment for Actinic Keratosis

A topical treatment applied twice daily for 4 weeks to induce disappearance of facial actinic keratosis (AK). First 4 weeks treatment (visit 1, 2 and 3 at 0,2 an 4 weeks) treated as a double blind parallel study. From weeks 4 to 7 (visit 3 to visit 4) all patients to be treated by the active component.


Eligibility Criteria:
Inclusion Criteria:

* Males or females 30 to 90 years old, inclusive, in good general health
* Clinical diagnosis of Actinic Keratosis
* At least 2 clinically diagnosed, 3-15 mm AK lesions on face or scalp
* Patient is competent to understand and sign a consent form, and is willing and able to follow study procedures and attend all visits
* Female patients of childbearing potential must have a negative urine pregnancy test prior to receiving study medication
* Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception
* Pharmacologic methods of contraception should be stable for 1 month prior to Visit 1 and be maintained at same dose during the study

Exclusion Criteria:

* Patients who had been treated with: 5-FU, diclofenac, retinoids, ingenol mebutate or imiquimod within 4 weeks of study, immunomodulators, or interferon/interferon inducers or systemic immunosuppressants within 8 weeks of study, cryodestruction, curettage, photodynamic therapy, surgical excision on the treatment area within 4 weeks of study, systemic cancer therapy, UVA therapy, UVB therapy, laser abrasion, dermabrasion
* History of hereditary angio-edema, Epilepsy or Parkinson's Disease
* Erythroderma or history of immunodeficiency disorders
* Pregnancy, lactation or patient who is not practicing effective contraception
* History of alcohol and drug abuse within 5 years of screening
* Known hypersensitivity or previous allergic reaction to any of the components of the study medication
* Having a member of the same household in the trial
* Patient has participated in an investigational clinical, surgical, drug or device study within the past 30 days
* Patients who in the opinion of the investigator should not be included in the study for any reason, including inability to follow procedures
A Prospective Trial to Compare Deep Inspiratory Breath Hold (DIBH) With Prone Breast Irradiation

This phase II trial studies how well deep inspiratory breath hold or prone breast radiation therapy works in reducing cardiac dose in patients with breast cancer or ductal carcinoma in situ. Deep inspiratory breath hold is a technique that involves a patient holding their breath during radiation to move the heart away from the breast to minimize radiation to the heart. Prone breast radiation therapy is a technique in which a patient receives treatment "face-down" to minimize the radiation to the rest of the body, including the heart and lungs. Comparing deep inspiratory breath hold to prone breast radiation therapy may help doctors improve radiation to the target while reducing radiation to healthy tissues surrounding the target.

Patients attend a simulation visit and undergo two CT scans, one in the prone position and one in the supine position with DIBH. Within 1 week after the simulation visit, patients undergo radiation therapy either in the supine position with DIBH or in the prone position daily for 15-30 consecutive days as per physician's prescription

Eligibility Criteria:
Inclusion Criteria:

* Any woman with biopsy proven left breast DCIS or invasive cancer who has undergone a lumpectomy and who requires whole breast irradiation to the breast alone (and not to any nodal regions) as per the treating radiation oncologist

Exclusion Criteria:

* Previous radiation to the ipsilateral breast
* All pre-menopausal women will require a urine qualitative pregnancy test to exclude pregnancy; pregnant women will be excluded from the study
Sleep Apnea-hypopnea Syndrome (SAHS) and Ventricular Arrhythmias

Hypothesis:

The CPAP treatment diminishes the effect of ventricular arrhythmias in patients with ischemic heart disease or dilated myocardiopathy, systolic ventricular disfunction and sleep apnea-hypopnea syndrome (SAHS)Objectives: To analyze the incidence of ventricular arrhythmias (premature ventricular beat, non-sustained ventricular tachycardia and sustained ventricular tachycardia) and appropriate defibrillator therapies in patients with ischemic heart disease or dilated myocardiopathy, moderate-severe left ventricular dysfunction,with an implantable cardioverter-defibrillator (ICD) and sleep apnea. To study the effect of CPAP on the cardiac arrhythmias and on the number of appropriate defibrillator therapies.

Design:

Parallel, randomized and single-blinded multicentric study to compare CPAP vs. hygienic-dietetic recommendations.

Patients with SAHS (AHI≥15) and systolic left ventricle dysfunction patients with an ICD.

Duration: 24 months.

Secondary objectives:

To compare the prevalence of SAHS in patients with ischemic heart disease or dilated myocardiopathy and moderate-severe left ventricle dysfunction with ICD with that of the general population. To study the incidence of supraventricular arrhythmias (atrial fibrillation, atrial flutter or supraventricular tachycardia) and inappropriate defibrillator therapies in these patients. To value the effect of the treatment with CPAP on the above mentioned arrhythmias. To relate the effect of ventricular and supraventricular arrhythmias with sleep parameters, cardiovascular biomarkers, inflammation and oxidative stress. To evaluate the long-term effect of the CPAP on systemic biomarkers in patients with ischemic heart disease or dilated myocardiopathy and moderate-severe left ventricle dysfunction. To evaluate the long-term effect of CPAP on the quality of life in these patients.

Sample size:

224 patients with ischemic heart disease or dilated myocardiopathy and moderate-severe left ventricle dysfunction with ICD will be included to randomize 19 SAHS subjects for arm.

Eligibility Criteria:
Inclusion Criteria:

* Previous diagnostic of ischaemic heart disease of dilated myocardiopathy
* Ejection fraction of left ventricle \< 40%
* Patients with implantable cardioverter-defibrillator

Exclusion Criteria:

* Diurnal hypersomnolence with EES \> 16
* Morbid obesity (BMI \> 35 Kg/m2).
* Moderate-severe chronic obstructive pulmonary disease (FEV1/FVC \< 70 % and FEV1 \< 80 % of reference).
* Known thyroid disease.
* Previous treatment with CPAP.
Effect a Honey, Spice-blended Baked Good Has on Salivary Inflammation Markers in Adults: a Pilot Study

The purpose of this research is to determine the effect a spiced-infused baked good has on inflammatory biomarkers in adults who are overweight and/or who has chronic kidney disease. Participants will be involved for 10 days in this research study.

The dietary intervention will for 10-days, in which participants will eat a baked good each day for a total of 10 days. This baked good contains honey and spices (cinnamon and turmeric). At the first day of the study, participants will provide a urine sample, saliva sample, be weighed, take a pregnancy test, complete a total of 3 surveys - dietary and spice intake and demographics. Each survey will take no more than 10 minutes for a total of 30 minutes. At the end of the 10 days, participants will provide a saliva sample and complete 2 surveys - dietary and spice intake. Each survey will take no more than 10 minutes for a total of 20 minutes. Each day of the baked good intervention, participants will tick off the amount of baked good consumed (100%, 75%, 50%, 25%, 0%).

Eligibility Criteria:
Inclusion Criteria:

* adults who have been diagnosed with CKD and/or have a BMI \>24.9
* have no additional chronic diseases or GI disorders or GI disturbances
* age 18 years or older
* no food allergies or dietary restrictions
* all with no contraindications to consuming anything by mouth as per their physician

Exclusion Criteria:

* no diagnosis of CKD or BMI \<24.9
* GI disorders, diagnosed with other chronic diseases and conditions, gastrointestinal disturbances
* pregnant and/or lactating
* under 18 years old
* food allergies to wheat, almonds, or aversion to turmeric, cinnamon, and honey. -Dietary restrictions as medically indicated
* trouble chewing/swallowing as confirmed by physician
Thromboembolic Complications in COVID-19 Patients in Intensive Care Unit

The present study aims to determine frequency of thromboembolic complications and the underlying causes of this complication of the patients who admitted to the intensive care unit diagnosed with COVID-19.

Patients diagnosed with COVID-19 infection and admitted to the ICU were recruited. Demographic information, comorbidities, length of ICU stay, some laboratory data,thromboembolic complications of the patients were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were infected with COVID-19 and admitted to the intensive care unit between the time of March 2020-December 2021

Exclusion Criteria:

* who is under 18 years old.
Non-alcoholic Fatty Liver Disease (NAFLD) in HIV: The Role of Nutritional Interventions

The purpose of this study is to evaluate the effect of a one-year nutritional intervention with either betaine or vitamin E supplementation, or a weight reducing diet and exercise program on liver steatosis and steatohepatitis.


Eligibility Criteria:
Inclusion Criteria:

* Baseline liver biopsy with macrovesicular fatty degeneration with inflammation (lobular or portal), with or without Mallory bodies, hepatocyte damage, and/or fibrosis diagnostic of NAFLD
* Convincing evidence of negligible alcohol consumption (\< 20 grams of ethanol per day) obtained from a detailed history, confirmed by at least one close relative
* If hyperlipidemia or diabetes, stable drug regimen required for the 6 months prior to and during the study
* Willingness to maintain stable weight and normal exercise program for the duration of the study, if randomized to vitamin E or betaine

Exclusion Criteria:

* Liver disease of other etiology diagnosed as per routine medical investigation (e.g., chronic viral hepatitis, auto-immune chronic hepatitis, primary biliary cirrhosis or genetic liver disease such as Wilson's disease, hemochromatosis, alpha-1 antitrypsin deficiency, or biliary obstruction)
* Complications of liver disease such as recurrent variceal bleeding, resistant ascites, spontaneous portosystemic encephalopathy, or bacterial peritonitis
* Concurrent medical illness contra-indicating a liver biopsy, history of unexplained bleeding, hemophilia or abnormal coagulation results as per routine laboratory work-up or other reason judged by the hepatologist to contra-indicate a percutaneous liver biopsy
* Medications known to precipitate steatohepatitis (corticosteroids, high dose estrogens, methotrexate, amiodarone, calcium channel blockers, spironolactone, sulfasalazine, naproxen, oxacillin or ampinovire) in the 6 months prior to entry
* Antioxidant vitamin supplementation, ursodeoxycholic acid, or any other experimental drug 6 months prior to study entry
* Pregnant or lactating