cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of a Smoking Cessation Algorithm Integrated Into HIV Primary Care

To determine the efficacy of an algorithm designed to recommend smoking cessation-related pharmacotherapy options to the primary care providers of smokers living with HIV/AIDS.

Smoking remains the leading cause of preventable death and disability in the United States. Whereas smoking has declined significantly among individuals in the general population, it is clustered in populations of vulnerable individuals such as people living with HIV/AIDS (PLWH) in whom smoking prevalence rates and resulting comorbidity rates remain high. Medical advances in the treatment of HIV have resulted in substantial increases in life expectancy among PLWH and as a consequence PLWH smokers are now, more than ever, at heightened risk for tobacco-related illnesses and death. PLWH smokers engaged in treatment lose more years of life due to smoking now than to HIV disease. Although PLWH smokers engaged in HIV care typically see a medical provider every 4-6 months, smoking cessation treatment and referral is often not part of routine HIV care. While 94% of HIV treatment providers indicated that they would be willing to provide smoking cessation services to their patients, few have received training in how to provide smoking cessation services. With seven first line pharmacotherapies available for smoking cessation, development of algorithms to assist providers in selecting the most appropriate pharmacotherapy is an important but untested strategy to increase smoking cessation in PLWH. The purpose of this proposal is to conduct a mixed efficacy/effectiveness trial comparing an algorithm treatment with prescription cost off sets and quit line referral (AT) to an enhanced Treatment as Usual (quit line referral only; eTAU) group. Six hundred PLWH smokers will be recruited at the University of Alabama at Birmingham, University of Washington, and Fenway Health HIV clinics and will be randomized to receive AT or eTAU. All AT smokers will receive active treatment for twelve weeks regardless of stated motivation or intention to quit. eTAU smokers will be referred to quit line services and HIV providers may elect to treat smoking as part of standard of care. Participants will remain in the study for 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Enrollment in the CNICS clinical cohort.
2. 18 years or older;
3. Receiving HIV care at the UAB, UW or Fenway Health clinics and not anticipating changing clinics over the next six months
4. Smoking greater than or equal to 5 cigarettes per day (cpd) for the past month
5. Living in an unrestricted environment that allows smoking.

Exclusion Criteria:

1. Cognitive impairment such that unable to provide informed consent;
2. Non-English speaking;
3. Acutely suicidal, manic, acutely intoxicated, or otherwise not stable enough to provide informed consent;
4. Currently receiving smoking cessation treatment.
Strain Imaging in Patients With Functional Mitral Regurgitation, Treated With MitraClip

The aim of this study is i) to evaluate left ventricular global longitudinal strain and myocardial work in patients with heart failure and severe functional mitral regurgitation one year after MitraClip implantation and compare these variables with patients treated with optimal medical treatment and ii) to find echocardiographic predictors of clinical response and reverse left ventricular remodeling at one-year follow up.

This study is one of the first in terms of publication. As far as the investigators know there are few papers with small series of patients regarding echocardiographic parameters and strain imaging in patients with functional mitral regurgitation (MR) and MitraClip. As the investigator's goal is to assess the potential impact of the MitraClip on myocardial deformation indexes, at the end of the study a direct comparison of changes of echocardiography markers -at one year follow up- between the control and device group will be performed. The changes in myocardial deformation markers will be associated with the respective changes in Brain-natriuretic peptide (BNP) levels, New York Heart Association (NYHA) class status, 6-minute walking distance (6MWD) and left ventricle (LV) volumes at follow -up. The investigators also aim to identify baseline prognostic echocardiography markers for the prediction of clinical improvement and LV reverse remodeling after successful edge-to-edge repair in functional MR patients during one year follow up. In specific, in this study the investigators will measure the 2-Dimension (2D) strain values of the left ventricle and left atrium (global longitudinal strain-GLS of the LV and Peak Atrial longitudinal strain - PALS of the left atrium) at baseline and at one year follow up, they will appreciate the LV myocardial work and all its components (Global Work Index-GWI, Global Constructed Work-GCW,Global wasted work-GWW and Global Work Efficiency-GWE) of the left ventricle and finally they will evaluate the baseline variables as predictors of reverse LV remodeling defined by reduction of left ventricle end-diastolic and end-systolic volume at one-year follow up.

Eligibility Criteria:
Inclusion Criteria:

* patients with EF more than 15% and below 45%
* Heart failure symptoms with NYHA class \>2
* Moderate-to-severe and severe functional Mitral regurgitation

Exclusion Criteria:

* degenerative mitral regurgitation
* asymptomatic patients
* NYHA class IV patients not able to perform 6MWT
* EF\>45%
* poor echocardiographic acoustic window patients
Low Field Magnetic Stimulation: Open Label Study.

To assess the effects of daily LFMS treatments for those suffering from affective or anxiety symptoms. We hypothesize a reduction in affective and or anxiety symptoms after active treatment over the period of one week, with improvement through the following week.

The Low Field Magnetic Stimulation (LFMS) procedure is an application of a series of electromagnetic pulses to the brain. The field and timing parameters of the LFMS pulses, such as pulse timing, duration, frequency, and electric and magnetic field distribution and direction are different from other neurostimulation methods. LFMS electromagnetic fields are significantly weaker (\< 100x) than those used in ECT and rTMS.

LFMS was discovered at McLean Hospital and has thus far been studied as an experimental antidepressant treatment at McLean Hospital. LFMS is also being studied at Massachusetts General Hospital and 5 other hospitals in an NIH sponsored trial (RAPID) as well as in studies at Cornell-Weill School of Medicine. The mechanism of action for the antidepressant effects of LFMS is hypothesized to be an interaction between the electromagnetic fields and neurons in cortical regions, brought about by low level electrical stimulation applied with particular timing.

The current study proposes to assess the effects of daily LFMS treatments in participants suffering from affective disorders and/or anxiety. This is an open-label study. All subjects will receive active LFMS treatments. Potential subjects will be referred to the study by their clinicians and will be pre-screened by phone.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects will be accepted into the study upon written referral by a McLean clinician or outside psychiatrist.
2. Subjects will be men or women over the age of 18.
3. Subjects must have failed at least one FDA approved treatment before enrolling in this study.
4. Subjects must be capable of providing informed consent.
5. Subjects must have either a Hamilton Depression Rating Scale (HDRS) score \> 14 indicating moderate depression or Hamilton Anxiety Rating Scale (HARS) score \> 18 indicating moderate anxiety.

Exclusion Criteria:

1. Dangerous or active suicidal ideation.
2. Pregnant or planning on becoming pregnant.
3. Recent history (within 3 days) of ECT or TMS treatment.
4. Substance abuse (cannot meet DSM criteria for substance abuse, no significant drug abuse within last 3 months, no history of dependence in last year, no drug use within last month, other than marijuana use).
5. Current psychosis.
6. Contraindications for MRI: Presence of a pacemaker, neurostimulator, or metal in head or neck.
7. "Do Not Resuscitate" order in place (to avoid risk in the case of non-study-related accidents).

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Malaria Rapid Diagnostic Tests (RDTs) in Pregnancy: Detection of Placental Malaria

This study seeks to determine whether screening pregnant women for malaria with malaria rapid diagnostic tests (RDTs) may detect placental infection and predict risk of poor birth outcomes due to malaria in areas of varied malaria transmission in Africa.

Malaria prevention measures for pregnant women are critical and available, but the effectiveness of intermittent preventive treatment (IPTp) with sulfadoxine-pyrimethamine, a cornerstone in this prevention effort, is declining with increasing parasite resistance. New drugs for IPTp are being considered, but there are disadvantages to presumptive use of the few remaining efficacious antimalarials. An alternative approach may involve screening with diagnostic tests to better target efficacious antimalarial treatment to asymptomatic women with laboratory evidence of malaria infection. Light microscopy of peripheral maternal blood misses a large proportion of cases, and PCR is unavailable in routine health care settings. Preliminary evidence suggests that detection of parasite antigen in peripheral blood may provide an accurate indicator of clinically significant infections and predict pregnancy outcomes. Therefore, screening with RDTs may offer an accurate and practical way to identify pregnant women who will benefit from targeted therapy for placental malaria infection. Antigen detection thresholds vary widely among RDTs, and the distribution of target antigens in peripheral blood circulation is expected to differ; therefore, the potential value of RDTs in this population can best be established by evaluating the detection of placental parasitemia for highly-characterized RDTs, enabling results to be extrapolated to other products and programs. The study described here is proposed to address this question.

Eligibility Criteria:
Specific participant selection criteria include:

1. Presenting for care after quickening and before onset of labor (i.e. in the second or third trimester of pregnancy)
2. Age between 16 years and 44 years, inclusive
3. Willingness and ability to follow up with study visits and activities through the duration of pregnancy and at delivery
4. Absence of history of serious adverse reaction to sulfa drugs
5. Absence of history of serious adverse reaction to artemisinin-based drugs (depending on national policy on treatment of malaria in pregnancy)
6. Absence of HIV infection (both because guidelines for malaria prevention in pregnancy for HIV-infected women differ from those for HIV-negative women, and in order to avoid confounding of pregnancy outcomes by HIV-related complications or treatments in this early evaluation)
7. Absence of history of or current obstetrical complications (e.g. pre-eclampsia, eclampsia, hypertension during pregnancy, post-partum hemorrhage, evidence of multiple gestation)
8. Absence of chronic disease (e.g. diabetes mellitus, sickle cell disease)
9. Absence of evidence of severe acute disease requiring inpatient management or referral
10. Provision of written informed consent
11. Enrollment Hb ≥7 g/dL
Implementation and Evaluation of a Social Journey Accompanied in Breast Cancer Diagnosis (EPARS SEIN)

Evaluate and compare the return to work rate at 12 months

Evaluate and compare the return to work rate at 12 months (from J1C1 \[first day of the first adjuvant chemotherapy regimen\]) between the "intervention" group (which has accompanied the career) and the standard group course

Eligibility Criteria:
Inclusion Criteria:

* Patient major\> 18
* Have a diagnosis of localized breast cancer requiring surgery immediately adjuvant therapy sequence including chemotherapy and radiotherapy
* Being more than 3 years of retirement at diagnosis
* Have a work contract valid at the time of diagnosis (before surgery)
* Do not practice a profession
* Be in possession of his rights (excluding guardianship, curatorship)
* Raise the general social security scheme and have rights to cash benefits in the Languedoc-Roussillon region

Exclusion Criteria:

* Patient minor
* Patient diagnosed with metastatic breast cancer
* Patients refusing to sign the consent
* Patients do not have sufficient understanding of the French language
* Patients for whom it is impossible to give clear information
Effect of Matrices on Serum Fructose.

Epidemiological evidence is accumulating that a high consumption of added sugars is associated with metabolic diseases such as non-alcoholic fatty liver disease and type 2 diabetes. Fructose, one of the principal added sugars, is believed to be the most disadvantageous sugar. Data from a large population-based cohort demonstrated that fructose intake from fruit juice and sugar-sweetened beverages, but not whole fruits, is associated with higher intrahepatic lipid content. A study in mice demonstrated that fast fructose exposure resulted in higher intrahepatic lipid content than slow fructose exposure.

The food matrix, i.e. the complex spatial organisation of and interactions between nutrients, may account for the fast versus slow fructose exposure and subsequent health consequences. Therefore the investigators aim to investigate the role of the fructose matrices on serum fructose peaks. The investigators hypothesize that liquid fructose matrices will cause higher serum fructose peaks in comparison to solid fructose matrices.

Objective: To quantify serum fructose peaks within 150 minutes following intake of fructose-containing matrices.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Body mass index (BMI) ≥18.5 kg/m2 and \<25 kg/m2

Exclusion Criteria:

* Pregnancy.
* Drugs and/or alcohol abuse.
* Diagnosis of diabetes mellitus.
* (History of) gastrointestinal and/or liver disease.
* (History \[\< 5 years\] of) cancer (excluding basal cell carcinoma)
* Physical stress one month prior to inclusion (i.e. post-surgery, trauma that requires medical treatment, bacterial/viral/fungal infection or extreme psychological stress). Symptoms of infection include: fever, (excessive) sweating \& chills, cough, sore throat, shortness of breath, nasal congestion, diarrhea, vomiting, painful miction, redness/swelling, stomach ache, head ache, and stiff neck.
* Unstable weight for 3 months prior to inclusion (i.e. 5% change in bodyweight)
* Allergy to one of the used food products in the study.
* Inability to provide written informed consent.
A Prospective Study of Hypothyroidism After Radiotherapy for Breast Cancer

This study is to prospectively investigate the incidence of hypothyroidism after postoperative radiotherapy and identify risk factors for development of hypothyroidism. Patients with breast cancer treated with surgery followed by radiotherapy is enrolled. Thyroid function was assessed at baseline and different times after radiotherapy. The radiation technique, thyroid dose parameters and hypothyroidism are prospective evaluated, and the dose-effect relationship is analyzed.

Breast cancer patients treated with radiotherapy after surgery are prospectively enrolled. Thyroid function is evaluated mainly by the measurement of thyroid-stimulating hormone (TSH), free triiodo-thyronine (FT3) and free thyroxine (FT4). Thyroid function is regularly assessed before and after radiotherapy. The radiation technique and thyroid dose parameters are assessed. Development of subclinical or biochemical hypothyroidism is noted. The incidence and risk factors of hypothyroidism is analyzed. The dose-volume constraints that correlate with functional impairment of the thyroid in breast cancer patients treated with radiotherapy is discussed.

Eligibility Criteria:
Inclusion Criteria:

Breast cancer patients at first diagnosis, patients who are treated with radiotherapy after breast conserving surgery or modified radical mastectomy, no medical history of hyperthyroidism, hypothyroidism or thyroiditis, have never taken thyroxine, no thyroid surgery.

Exclusion Criteria:

Absence or ectopic thyroid gland, previous radiotherapy of the neck, diseases of thalamus or pituitary, previous radiotherapy of thalamus or pituitary
Effectiveness of Ambu® aScope™ 4 Cysto With the aView™ 2 Advance for Flexible Cystoscopy

The purpose of this study is to evaluate the use of the single-use Ambu® aScope™ 4 Cysto for removal of ureteral stents as compared to routine flexible reusable cystoscopes.

This study is a prospective, randomized, multi-center, post-market investigation of the effectiveness of Ambu® aScope™ 4 Cysto (single-use cystoscope) as compared to routine flexible reusable cystoscopes (standard of care) for ureteral stent removals. The investigation will include approximately 102 subjects (randomized at a 1:1 ratio).

Eligibility Criteria:
Inclusion Criteria:

1. Adult (male or female), ≥18 years old
2. Patient undergoing routine flexible cystoscopy
3. Patient with a ureteral stent in the urinary system that is ready to be removed.
4. No active urinary tract infection
5. Subject is willing and able to sign informed consent and HIPAA authorization and comply with requirements of the protocol.

Exclusion Criteria:

1. History of prior bladder/urethral reconstructive surgery.
2. History of high-grade bladder cancer or carcinoma in-situ of the bladder, undergoing cystoscopy for follow-up/surveillance purposes.
3. Known unpassable urethral stricture
4. Febrile patient with active urinary tract infection (UTI)
5. Subjects with acute infection (acute urethritis, acute prostatitis, acute epididymitis)
6. Subject with severe coagulopathy
7. Patient is unable to read and/or understand study requirements
8. Patient is unable or unwilling to provide written consent to participate in the study.
9. Subject, in the opinion of the Investigator, has a severe comorbidity, poor general physical/mental health and/or a condition that will not
Yoga-Based Rehabilitation Program in Reducing Physical and Emotional Side Effects in Patients With Cancer

This clinical trial studies yoga-based rehabilitation in reducing physical and emotional side effects of living with cancer or its treatment. Yoga-based rehabilitation may reduce side effects and improve the quality of life of patients with breast, lung, or colorectal cancer.

PRIMARY OBJECTIVES:

I. To evaluate the effects of yoga on quality of life (QOL) of breast cancer patients on different treatment regimens.

II. To pilot the effects of a yoga-based rehabilitation program versus standard care on QOL impairment reported by newly diagnosed (a) lung and (b) colorectal patients.

III. To evaluate program compliance and satisfaction among breast, lung and colorectal cancer patients as well as among the various sociocultural subgroups (e.g., ethnicity, language).

OUTLINE: Participants are randomized to 1 of 2 arms.

GROUP I (YOGA-BASED REHABILITATION PROGRAM): Participants undergo a yoga-based rehabilitation program up to 5 days a week for 1.5 hours and practice at home at least once daily for 12 weeks.

GROUP II (STANDARD CARE/CONTROL): After a 3 month wait period, participants undergo yoga-based rehabilitation program as in Group I.

Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with breast, lung or colorectal cancer in the previous 8 weeks
* Are to receive oncologic care at the Albert Einstein Cancer Center (AECC)
* Have a life-expectancy of at least 6 months
* Are either English- or Spanish-speaking
* Do not practice yoga regularly (\> 1 month)
* Receive medical clearance by oncologic personnel on the study

Exclusion Criteria:

* Eastern Cooperative Oncology Group performance status \>= 3
* Existence of any of the following:

  * Seizure disorder
  * Musculoskeletal conditions
  * Heart problems
  * Major psychiatric disorder
Bioequivalence of Two Formulations of Esomeprazole

Bioequivalence of Two Formulations of Esomeprazole 40mg

A randomized, two-way crossover, single-dose pharmacokinetic study to evaluate the bioequivalence of a test formulation of Esomelone powder for solution for injection/infusion 40mg (Esomeprazole 40mg), compared to an equivalent dose of a reference drug product (Nexium powder for injection and infusion 40mg) in healthy adult subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult, aged between 20 to 40 years old.
2. Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, laboratory tests, chest x-ray and electrocardiogram.

   * no particular clinical significance in clinical examination and laboratory tests within two months (60 days) prior to Period I dosing.
   * normal or considered not clinically significant by the investigator chest X-ray and ECG results within six months (180 days ) prior to Period I dosing.
3. The normal range of the body mass index should be between 18.5 and 25; body mass index equals \[weight (kg)\]/\[height (m)\]2.
4. Normal laboratory determinations result (within normal range or considered not clinically significant by the investigator) including: SGOT (AST), SGPT (ALT), albumin, glucose, creatinine, uric acid, cholesterol, TG, r-GT, alkaline phosphatase, total bilirubin, BUN, HBsAg, Anti-HCV and Anti-HIV test.
5. Normal hematology results (within normal range or considered not clinically significant by the investigator) including: hemoglobin, hematocrit, WBC count with differential, RBC count and platelet count.
6. Normal urinalysis results (within normal range or considered not clinically significant by the investigator) including: glucose, protein, RBC, WBC, epith, casts and bacteria.
7. Female subject who is

   * using adequate contraception since last menstruation and no plan for conception during the study,
   * non-lactating.
   * has negative pregnancy test (urine) within 14 days prior to the study.
8. Informed consent form signed.

Exclusion Criteria:

1. A history of drug or alcohol abuse during the past 24 weeks.
2. Sensitivity to analogous drug.
3. A clinically significant illness (such as significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, melaena or gastric ulcer) within the past 4 weeks.
4. Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal pathology within the past 4 weeks.
5. Planned vaccination during the time course of the study.
6. Participation of ant clinical investigation during the last 60 days.
7. Regular use of any medication during the last 4 weeks.
8. Single use of any medication during the last 2 weeks.
9. Blood donation of more than 250 mL within the past 12 weeks.
10. Individuals are judged by the investigation or co-investigator to be undesirable as subjects.
The Study of the Validation of General Evaluation Score (GES) in the Prediction of Hepatocellular Carcinoma Risk Among Patients With Advanced Fibrosis and Cirrhosis Who Achieved Sustained Virological Response for Hepatitis C Virus After Direct Acting Antiviral Drugs

This cohort study aims to evaluate the validation of general evaluation score in the prediction of hepatocellular carcinoma risk among patients with advanced fibrosis (F3) and cirrhosis (F4) who achieved sustained virological response for hepatitis c virus after direct acting antiviral drugs and determine the group of these patients who require intensified surveillance.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18 years or older.
* Patients with compensated advanced chronic liver disease (cACLD) according to Baveno VI consensus (F3-F4)
* achieved SVR for HCV after DAAs.

Exclusion Criteria:

* Previous interferon (IFN) treatment.
* Hepatitis B virus (HBV) or human immune-deficiency virus (HIV) co-infection.
* Current hepatocellular carcinoma (HCC) or other malignancies.
* Previous history of HCC or HCC intervention.
* Liver cell failure, liver transplantation or renal impairment