cyrilzakka/clinical-trials huggingface dataset:
Lifestyle Changes Through Exercise and Nutrition

The goal of The LEAN project intervention is to promote weight loss, healthy dietary habits, increased physical activity, improved blood glucose and cholesterol, and weight related quality of life in obese African American adults through a sustainable, technology enhanced, church-based program.

The LEAN Project is a community-based weight loss program that is delivered through churches serving lower-income, obese, African American adults. The intervention will involve training community health coaches to deliver the intervention. These community health coaches will be individuals who are members of the church and who are willing to be trained on how to deliver behaviorally-based, empirically proven, lifestyle change interventions. These community health coaches will be trained by the staff at Pennington Biomedical, who have experience training and delivering these types of interventions. The community health coaches will deliver the intervention through their respective church after being trained. Weekly text messages will be sent to participants in order to supplement the intervention sessions and provide support. The primary aim is to determine if the trained community health coach church-based intervention will result in significant weight loss. Secondary aims will assess blood glucose, cholesterol, physical activity, food intake, and weight related quality of life.

Eligibility Criteria:
Inclusion Criteria:

* self-identify as African American
* a member of a participating church
* age 18-75 years old
* BMI \> 30
* own a mobile phone with text message capabilities
* at risk for diabetes (diagnosed nuclear family member or gestational diabetes) or diagnosed with type 2 diabetes
* willing to provide written informed consent
* willing to change diet, physical activity and weight
* able to participate in face-face counselling sessions as scheduled
* low to moderate cardiovascular disease risk

Exclusion Criteria:

* currently participating in a weight loss program
* currently using weight loss medication or have lost weight (\>10 lbs in last year)
* planning to move from the area within the next year
* given birth within the past year, are currently pregnant or plan to become pregnant within the next year
* planning to have bariatric surgery within 2 years
* history of major depression, suicidal behavior or eating disorder
* hospitalization for a mental disorder or substance abuse in the last year
* have cancer or had cancer within the past 5 years.
* serious heart problems such as arrhythmias, cardiomyopathy, congestive heart failure
* stroke or heart attack in the last six months
* high blood pressure \[systolic ≥160, or diastolic ≥100\]
* chronic inflammatory conditions, including but not limited to severe arthritis, lupus, or inflammatory bowel disease
* diseases that are life threatening or that can interfere with or be aggravated by exercise or weight loss
* unwilling or unable to provide informed consent
* physician's or principal investigator's decision to exclude
Evaluation of Intravenous Infusion of Labetalol Versus Magnesium Sulfate

the purpose of this study is to compare Intravenous infusion of Labetalol versus Magnesium Sulfate on Cerebral Hemodynamics of Severe Preeclampsia Patients using Transcranial Doppler

after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into 2 groups each one containing 30 patients , (Group M) : will be given intravenous infusion of magnesium sulfate at a dose of 4 gm intravenously over 20 min as a loading dose then MgSO4 intravenous infusion is continued at a rate of 1 gm/h for 24 h or until obtain and stabilize the targeted blood pressure..

(Group L) : The patients will be given intravenous infusion of labetalol (Trandate™,) available in 20 ml ampoules containing 100mg labetalol (5mg/ml). Starting the infusion with 20mg/h and then titrate to obtain and stabilize the targeted blood pressure by adjusting the infusion as required every 15 - 30min to a maximum dose of 160mg/hr.

Eligibility Criteria:
Inclusion Criteria:

* acceptance
* 21 to 45 years old.
* mass index ≤ 35 kg/m2.
* Singleton Pregnant female complicated with severe preeclampsia
* Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 110 mmHg on two occasions at least 4 hours apart
* Thrombocytopenia (platelet count less than 100,000 )
* Impaired liver function indicated by elevated liver enzymes (to twice the upper limit normal concentration), and severe persistent right upper quadrant or epigastric pain not responding to medications and not explained by another diagnosis.
* Renal insufficiency (serum creatinine concentration more than 1.1 mg/dL or doubling of the serum creatinine concentration in the absence of other renal disease)
* Pulmonary edema
* New-onset headache unresponsive to medications and not accounted for by alternative diagnoses
* Visual disturbances.

Exclusion Criteria:

* Preexisting heart disease
* Known pulmonary disorders.
* Inadequate temporal window.
* Atrial fibrillation and any rhythm abnormality.
* History of allergy or contraindications to either magnesium sulfate or labetolol.
* Exposure to any of the study medications within 24 hours of enrollment.
The Impact of Pain on Depression Outcomes

This study is a secondary data analysis of three of largest Randomised Controlled Trials (RCTs) of behavioural activation (BA) for older people with depression in the United Kingdom (UK) primary care. The analysis will aim to explore the impact of pain on depression outcomes of older people receiving BA and potentially identify sub-groups of people who may not respond as well to treatment.

Previous findings have indicated that pain might be an important barrier in depression treatment both with antidepressant medication and in a United States (US) collaborative care model using problem solving therapy and antidepressant medication. It is unknown, however, if pain impacts depression outcomes of older adults in a collaborative care (CC) framework focusing on a brief psychological intervention of BA. Collectively CASPER, CASPER PLUS (+) and SHARD are three of the largest pragmatic, multi-centre randomised controlled trials (RCT) of BA for older adults in UK primary care with low mood and depression. The purpose of this secondary data analysis is, therefore, to explore if pain moderates (modifies) the effect of BA on depression outcomes in older adults, potentially identifying subgroups of older adults who may not respond as well to BA.

Eligibility Criteria:
Inclusion Criteria:

* Patients who participated in CASPER, CASPER + or SHARD study

Exclusion Criteria:

* Anyone who did not consent into one of the three studies above
Sustainability in Urologic Practices

This research is a two-phase observational study assessing awareness, current practices, barriers, and policy suggestions related to sustainability in urology. The study involves collecting survey data from a broad participant group and conducting a Delphi consensus with experts to develop actionable recommendations.

This study aims to evaluate and promote sustainable practices in urological care by focusing on the environmental impact of urological devices and processes. The study will be conducted in two phases, aiming to assess current practices, challenges, and strategies for reducing the carbon footprint and waste associated with urological procedures, while achieving expert consensus. Participants will include European Association of Urology (EAU) section chairs and board members, ensuring comprehensive analyses and authoritative recommendations.

In the first phase, an online survey will be administered to 150-200 participants. The survey will be distributed via platforms such as Google Forms or Qualtrics and will collect data on awareness, current practices, and challenges related to the environmental sustainability of urological devices. These findings will serve as the foundation for the Delphi consensus process in the second phase.

In the second phase, a Delphi panel consisting of 12-15 experts nominated from EAU sections will conduct a structured consensus process. This process will include three rounds:

1. Round 1: Open-ended questions will be used to gather expert opinions based on the findings of the survey.
2. Round 2: Proposed strategies will be evaluated and prioritized by the panel.
3. Round 3: Consensus will be reached on actionable recommendations for sustainable practices.

Participation in the study will be entirely voluntary, and informed consent will be obtained from all participants. All data collected during the survey and Delphi processes will be anonymized and used solely for the purposes of the study. Data will be handled in compliance with the General Data Protection Regulation (GDPR) and applicable local data protection laws.

Eligibility Criteria:
Inclusion Criteria:

* EAU Section Chairs and Board Members
* Individuals who voluntarily agree to participate in the study.

Exclusion Criteria:

* Individuals who refuse to participate in the study.
* Individuals who do not provide the required information or complete the survey incompletely.
Vaginal Preparation Prior to Hysterectomy

This is a randomized controlled trial to determine the influence of chlorhexidine gluconate surgical/topical antiseptic solutions on the bacterial environment of the vagina during hysterectomy and compare that to the effect of standard iodine-based preparations on the same.

Postoperative infection remains the most common complication of surgical procedures in gynecology. Historically, 30-40% of patients undergoing a hysterectomy develop a post-operative infection. The initiation of antibiotic prophylaxis for appropriate surgical procedures was a significant advancement in the prevention of surgical site infection.

Antibiotic prophylaxis has been standardized and universally implemented. A remaining variable is the method of aseptic preparation of the vagina with substantial variation of technique being reported even within institutions.

The most recent Committee Opinion by the American College of Obstetricians and Gynecologists concludes there is insufficient evidence to render a strong recommendation for either povidone-iodine or chlorhexidine as the ideal agent for surgical preparation of the vagina and that further evidence is necessary.

Povidone-iodine solution has been considered the standard for aseptic surgical preparation of the vagina for decades and is the only solution approved by the FDA for vaginal use. There are however specific qualities of the solution that suggest it may be less than ideal for use in the vagina. More contemporary efforts have begun to focus on chlorhexidine as a more ideal agent for aseptic efforts in surgical preparation of the vagina.

The purpose of our study is to use a randomized controlled trial to determine if chlorhexidine gluconate surgical preparation maintains a lower rate of contamination to the surgical field.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing total vaginal, laparoscopic assisted vaginal, total laparoscopic, or robotic-assisted laparoscopic hysterectomy by a physician at Cincinnati Urogynecology Associates or Tri-State Gynecology Oncology TriHealth Inc.
* Concomitant procedures such as vaginal vault suspension, suburethral sling, cystoscopy, enterocele repair, anterior or posterior colporrhaphy, bilateral salpingectomy or salpingooophorectomy, staging procedures, lymph node sampling and other indicated procedures will be included
* English speaking
* Ability to provide consent

Exclusion Criteria:

* Unwillingness to participate in the study
* Non English speaking
* Patients that do not undergo a hysterectomy
* Reported allergy to iodine or chlorhexidine preparation solutions
* Patients undergoing planned debulking surgery for ovarian, fallopian tube or primary peritoneal cancers
* Current infection necessitating hysterectomy
* Active sepsis, pelvic abscess or pelvic inflammatory disease
High Altitude (HA) Residents With Pulmonary Vascular Diseases (PVD), 6 Minute Walk Distance (6MWD) Assessed at 2840m (HA) With and Without Supplemental Oxygen Therapy (SOT)

The investigators aim to study the effect of SOT in participants with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension (PH) who permanently live \>2500m on 6-minute walk distance (6MWD) assessed at 2840m.

Participants with PVD diagnosed with precapillary PH with right heart catheterization and classified to groups 1 and 4 (PAH or CTEPH) who permanently live at HA \>2500 (PVDHA) will have 6-minute walk distance near their living altitude in Quito at 2840m with and without SOT at 3l/min via nasal cannula according to a randomized cross-over design.

Eligibility Criteria:
IInclusion Criteria:

* Adult patients 18-80 years old of both genders,
* Residence \> 2500m of altitude
* diagnosed with precapillary PH (mean pulmonary artery pressure (mPAP) \>20 mmHg, pulmonary artery wedge pressure (PAWP) ≤15 mmHg and pulmonary vascular resistance (PVR) ≥2 wood units (WU) by right heart catheterization) with PH being classified as PAH or CTEPH according to guidelines
* Patients stable on therapy
* New York Heart Association (NYHA) functional class I-III
* Provided written informed consent to participate in the study.

Exclusion Criteria:

* Age \<18 years or \>80 years
* unstable condition
* Patients who cannot follow the study investigations, patient permanently living \< 2500m.
* Patients with moderate to severe concomitant lung disease (FEV1\<70% or forced vital capacity \<70%), severe parenchymal lung disease, severe smokers (\>20 cigarettes/day)
* Severely hypoxemic patients at Quito permanently have persistent oxygen saturation by pulseoximetry (SpO2) \<80% on ambient air.
* Patients with chronic mountain sickness (Hemoglobin \> 19 g/dl in women, \>21 g/dl in men)
* Patient with a non-corrected ventricular septum defect
* Relevant concomitant other disease of the heart, kidney, liver, blood (anemia hemoglobin\<11 g/dl)
Osteopathic Manipulation for Female Interstitial Cystitis Patients With Sacroiliac Joint Dysfunction

The proposed study will evaluate the effectiveness of Osteopathic manipulation of the sacro-iliac joint (SIJ) and the lumbar spine in symptomatic female interstitial cystitis (IC) patients with sacro-iliac joint dysfunction.

It is predicted that Osteopathic manipulation for a period of 12 weeks will result in subjective indices of increased comfort and objective indices of lower O'Leary-Sant Questionnaire, Pelvic Floor Impact Questionnaire (PIFQ-7), Female Sexual Function Index (FSFI) and SF-12 scores, lower visual analog scores for pain and urgency, decreased frequency on voiding diary and greater variation in resting/contraction perineometry scores.

Patients will be evaluated and examined by an Osteopathic physician. This examination will consist of full osteopathic structural exam, and a focused examination of the sacroiliac joint and the surrounding musculature.

Subjects will then be treated based on the objective findings of the examination. Since the structural exam includes the whole body, other structural abnormalities will likely be identified and possible require treatment to aid in treatment of SIJD. Subjects will also be taught stretching routines in order to aid in treatment of the dysfunction.

Our control group will receive the same structural exam, and focused examination. Their treatment will involve massage, in an area not associated with the musculature of the SIJ. This will serve to identify a possible placebo effect, associated with simply providing a healing touch without focused treatment.

All of the subjects will be evaluated with standardized IC questionnaires at time of initial visit and subsequently re-evaluated with the same questionnaire in 4 week intervals. The patients will be followed for up to 6 months after treatment and evaluated at this time.

Eligibility Criteria:
Inclusion Criteria:

* Female
* At least 18 years of age
* Patients who have osteopathic dysfunction
* Patients with the Diagnosis of IC and Sacroiliac joint dysfunction
* Patients currently stable on or off of a treatment regimen for IC for the past one month
* Patients not currently undergoing physical therapy for pelvic floor dysfunction or SI joint dysfunction
* Patients who have not used narcotics, skeletal muscle relaxants, or bladder instillations for the past month
* Willingness to participate in the trial by signing an informed consent

Exclusion Criteria:

* Pregnancy
* Pelvic Masses
* Patients with an Interstim neuromodulator implant
* Patients requiring narcotics, bladder instillations, or skeletal muscle relaxants
* History of vaginal or abdominal pelvic surgery within the last 3 months
* Having a bladder over-distention within the last 1 month
* Malignancy
* Known spinal arthropathies
* Hip replacements or other surgical stabilization
* Herniated disks
* Spinal stenosis
Effect of CPAP Treatment in Patients With Severe Uncontrolled Asthma: The ASTHMA-SLEEP Trial

The aim of the study is to evaluate the impact of CPAP treatment on asthma control in patients with severe uncontrolled asthma and obstructive sleep apnea (OSA)

Background: The prevalence of obstructive sleep apnea (OSA) is high in patients with severe uncontrolled asthma and can worsen asthma control. Previous observational studies demonstrated that CPAP treatment could improve control in patients with mild-moderate asthma. Nevertheless, there are no studies in patients with severe uncontrolled asthma.

Primary objective: To evaluate the impact of CPAP treatment on asthma control in patients with severe uncontrolled asthma and AOS.

Methodology: Multicenter, prospective, randomized, controlled clinical trial with parallel groups in subjects with severe uncontrolled asthma who are older than 18 years and without sleepiness (Epworth sleepiness scale score ≤10). All included subjects will undergo conventional polysomnography and those with an apnea-hypopnea index (AHI) ≥15/hour will be randomized in a 1:1 ratio to receive conservative treatment or conservative treatment plus CPAP. Monitoring will be carried out during12 months. Patients will be evaluated at inclusion, at 1 month, 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Diagnosis of severe uncontrolled asthma according to the criteria of the Spanish Asthma Management Guide (GEMA) or the Global Initiative for Asthma (GINA) and no hospitalizations the month prior to inclusion in the study.
* Punctuation in the Epworth Sleepiness Scale ≤10
* Obtaining informed consent.

Exclusion Criteria:

* Previous treatment with CPAP
* Patient with central sleep apnea or Cheyne-Stokes respiration
* Other sleep disorders: narcolepsy, restless leg syndrome, chronic insomnia,
* Resistant hypertension
* Active Smoking
* Unstable comorbidities or medications may interfere with asthma control
* Pregnancy
* Any process that reduces life expectancy to \<1 year,
* Any medical or social factor that may limit CPAP compliance
Sex Differences in Reflex Responses to Intermittent Hypoxia

The purpose of the present study is to determine whether there are sex differences in the reflex responses to hypoxia in humans.

Over 35% of the US population will develop sleep apnea at some point in their life. Sleep apnea is the most common form of sleep disordered breathing and patients with sleep apnea are at increased risk of developing high blood pressure. Intermittent, repeated exposures to low oxygen during sleep (intermittent hypoxia, IH) has been implicated as the primary stimulus for increases in sympathetic nervous system activity and blood pressure with sleep apnea. Interestingly there are some reports of a lower incidence of hypertension in women with sleep apnea when compared to men. Results from the present study will provide information important to the investigator's understanding of potential sex-differences in clinical outcomes for conditions related to acute/chronic hypoxia and may have important implications for treatments which may improve blood pressure control in patients with sleep apnea.

Eligibility Criteria:
Inclusion Criteria:

* healthy adult men and women;
* BMI \<30 kg/m2;
* non-pregnant;
* non-breastfeeding;
* non-smokers;
* premenopausal women with a normal menstrual cycle unaffected by hormonal contraceptive use;
* taking no medications known to affect autonomic or cardiovascular function (PI discretion).

Exclusion Criteria:

* taking any medications known to affect the cardiovascular or autonomic nervous system (e.g. alpha-blockers, beta-blockers, etc);
* a self-reported history of hepatic, renal, pulmonary, cardiovascular, or neurological diseases;
* stroke or neurovascular disease;
* bleeding/clotting disorder;
* sleep apnea or other sleep disorders;
* diabetes;
* smoking;
* history of alcoholism or substance abuse;
* hypertension.
Comparison of Digital Electronic Stethoscope to Computed Tomography (CT) Angiography in Detection of Coronary Artery Disease

The study is designed to evaluate the predictive diagnostic accuracy of SonoMedica's CardioSond digital electronic stethoscope in the detection of coronary artery disease (CAD) in patients without known disease who are referred to cardiac computed tomography angiography (CT scans).

The CardioSond is a completely noninvasive medical device which detects heart sounds and murmurs using ultrasensitive acoustic technology. The CardioSond produces a flow micro bruit score which is used to determine the likelihood of coronary artery disease.

The CardioSond exam will be given to patients who agree to participate in the study upon signing of an informed consent form and prior to the administration of beta blocker agents and / or vasodilators as part of the normal cardiac CT angiography protocol.

CardioSond data will be sent to an independent acoustic core lab which will determine data quality and produce a flow micro bruit score. CT angiography data will be analyzed by staff at North Shore University Hospital.

A data review panel lead my the principal investigator will examine the results of both the CardioSond and CT angiography data to determine the accuracy of the CardioSond in detecting CAD in the study population at large and in specific patient subgroups.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are undergoing routine screening coronary CT angiography
* Willingness to sign informed consent form

Exclusion Criteria:

* Inability to provide informed consent form
* Age less than 21 years
* Any contraindications to coronary CT angiography
* Known atherosclerotic heart disease, including a history of prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery or an established diagnosis of CAD by prior X-ray or CT angiography
* Supraventricular or ventricular arrhythmias that would be expected to affect CT-angiography image quality (e.g., atrial fibrillation, atrial flutter, ventricular tachycardia, bigeminy, and trigeminy). Patients with isolated premature atrial contractions and premature ventricular contractions may enroll.
* Use of intravenous vasodilators
* Any pulmonary conditions that would create abnormal physical findings that would interfere with the fidelity of the cardiac sound recording (e.g., obstructive pulmonary disease, such as asthma or COPD, with audible wheezing).
* Presence of audible aortic or pulmonic diastolic murmurs, tricuspid or mitral flow diastolic murmurs, or continuous murmurs