cyrilzakka/clinical-trials huggingface dataset:
Mannitol Versus Nitroglycerin for Kidney Injury Prevention in Robotic-assisted Radical Prostatectomy or Cystectomy

Laparoscopic and minimally-invasive robotic access has transformed the delivery of urological surgery. While associated with numerous desirable outcomes including shorter post-operative stay and faster return to preoperative function, these techniques have also been associated with morbidity such as reduced renal blood flow and post-operative renal dysfunction. The mechanisms leading to these renal effects complex are multifactorial, and have not been fully elucidated. However they are likely to include direct effects from raised intra-abdominal pressure, and indirect effects secondary to carbon dioxide absorption, neuroendocrine factors and tissue damage from oxidative stress. It is well documented that pneumoperitoneum places profound stress on the cardiovascular, respiratory and gastrointestinal systems; it also places strain on the renal system.

During robotic surgery, continuous pneumoperitoneum and continuous rising of intra-abdominal pressure causes transient oliguria. Moreover, kidney function, estimated by the GFR, deteriorates during elevated intra abdominal pressure (IAP), and most of the studies identified decrease in renal blood flow (RBF) and renal cortical perfusion.

Studies conducted to assess the contribution of the nitric oxide (NO) system to the renal hemodynamic/function alterations during pneumoperitoneum, concluded that these adverse effects are probably related to interference with the NO system, and could be partially ameliorated by pretreatment with nitroglycerine.

Mannitol is an osmotic diuretic and a renal vasodilator that promotes tubular flow, prevents intratubular cast formation, decreases postischemic cellular swelling, and might serve as a free radical scavenger. Mannitol has traditionally been administered before renal surgeries to minimize perioperative renal dysfunction according to preclinical animal studies and clinical experience with renal transplantation. However, high-level clinical data in support of this belief are not available.

The aim of this study is to characterize the effects of increased intra-abdominal pressure on renal perfusion and function in cases undergoing robotic lower tract urologic surgeries, and to assess the contribution of either mannitol or nitroglycerin infusion to the renal hemodynamic/function alterations during pneumoperitoneum.


Eligibility Criteria:
Inclusion Criteria:

* ASA class I - III
* Normal renal functions or Mild renal disease (GFR \< 60 ml/min \&/or presence of albuminuria \> 30 mg/dl)

Exclusion Criteria:

* BMI \> 40
* Previous renal surgery
* Moderate (GFR 30 - 59 mg/dl) \& severe (GFR 15 - 29 mg/dl) renal impairment
* Decompensated cardiac disease: New York Heart Association (NYHA) class 3 or 4
* Allergy to mannitol or nitroglycerin
Endotoxin and Inflammatory Markers in Healthy Non-Smokers and Current Smokers Including Patients With Chronic Obstructive Pulmonary Disease (COPD)

The primary aim of this study is to investigate the effects of inhaled lipopolysaccharide endotoxin (LPS) on bronchial and alveolar exhaled nitric oxide (NO) and NO metabolites and other inflammatory markers and mediators in exhaled breath condensate, induced sputum, nasal lavage and mouthwash fluid in healthy non-smokers and current smokers, including patients with chronic obstructive pulmonary disease (COPD).


Eligibility Criteria:
Inclusion Criteria:

* Healthy non-smokers: normal spirometry (forced expiratory volume in 1 second \[FEV1\] more than or equal to 90% predicted) and normal exhaled NO (between 8 and 24 ppb; flow 50 ml/s)
* 0: At risk (current or ex-smokers): normal spirometry, with or without chronic symptoms (cough, sputum production)
* I-II: Mild-moderate COPD

  * FEV1 reversibility of \< 15% after inhaled beta2-agonists
  * FEV1/forced vital capacity (FVC) \< 70% predicted
  * FEV1 between greater than or equal to 50% and less than 80%
  * With or without chronic symptoms (cough, sputum production)
* Able to comprehend and grant a written informed consent

Exclusion Criteria:

* Concomitant use or pre-treatment within the last 4 weeks with oral steroids
* Respiratory infection within 4 weeks prior to entry into the trial
* Females who are pregnant or lactating
* History of current or past drug or alcohol abuse
Rhomboid Intercostal Block Versus Retrolaminar Block for Postoperative Analgesia After Thoracoscopic Sympathectomy

Background: Although thoracoscopic sympathectomy is made via small incisions, it is associated with severe postoperative pain. Both Rhomboid intercostal block (RIB) and Retrolaminar block (RLB) are recent techniques used for pain control after such procedures

Objectives: To compare the effectiveness of RIB and RLB in providing postoperative analgesia after thoracoscopic sympathectomy in adult patients and their impact on the patient's outcomes.

Patients and Methods: This prospective, randomized (1:1), double-blind clinical trial; will be carried out on 60 patients scheduled for elective thoracoscopic sympathectomy under general anesthesia at our hospital. Patients will be randomly allocated into two equal groups (30 patients each) and will receive: in group A; general anesthesia with intraoperative ipsilateral ultrasound-guided RIB, whereas in group B; general anesthesia with intraoperative ipsilateral ultrasound-guided RLB.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status ≤ II
* Age from 18 to 60 years
* Body Mass Index (BMI) \< 35 kg/m²

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status \> II
* Age \< 18 years or \> 60 years
* Body Mass Index (BMI) ≥ 35
* Local infection at the puncture site
* Altered mental status
* Pregnant women
* Allergy to study drugs
* Chronic pain
* Coagulation abnormalities or on anticoagulants
* Severe hepatic or kidney disease
Acute Effects of rhBNP in Patients With PH Associated With Acute Exacerbation of Chronic Pulmonary Disease

To evaluate the acute effect of recombinant human brain natriuretic peptide(rhBNP) on pulmonary hypertension of acute exacerbations of chronic pulmonary disease. rhBNP was administered as a continuous infusion for 24 hours , pulmonary artery pressure and other hemodynamic parameters were monitored by Swan- Ganz catheter.

Pulmonary hypertension (PH) is a descriptive name for abnormally elevated pressures in the pulmonary vasculature, which seriously affects the quality of life and survival of patients. Currently, no effective drugs treatment was used in patients with pulmonary hypertension due to acute exacerbation of lung disease. Recombinant Human Brain Natriuretic Peptide (rhBNP)was approved in 2001 for use in patients with acute heart failure on the basis of studies showing a reduction in pulmonary-capillary wedge pressure(PCWP) and pulmonary arterial pressure (PAP) and improvement cardiac output (CO) . Thus, the study was designed to administer rhBNP as a continuous infusion for 24 hours on pulmonary hypertension of acute exacerbations of chronic pulmonary disease monitoring by Swan- Ganz catheter. Each patient was studied on two occasions (6 hours apart). One occasion the subject received rhBNP 1.5ug/kg IV bolus followed by an infusion of 0.0075ug/kg/min for 24 hours; other occasion the subject received IV placebo bolus followed by a placebo infusion for 24 hours .these were administered in random order in double blind fashion.

Eligibility Criteria:
Inclusion Criteria:

1. age\>18 years old, male or female;
2. in acute exacerbation period and with a history of chronic respiratory diseases;
3. cardiac ultrasound showed a pulmonary hypertension ≥50mmHg;
4. grade II or WHO grade of heart function;
5. signed informed consent.

Exclusion Criteria:

1. pulmonary hypertension not associated with chronic lung disease;
2. Acute or severe chronic left heart failure;
3. severe respiratory failure during receipt of non-invasive or invasive ventilator therapy;
4. mPAP≤25mmHg or pulmonary capillary wedge pressure (PCWP) ≥15mmHg at rest as assessed by Swan- Ganz catheter;
5. a high risk of hypotension (systolic pressure \<100 mmHg or 110 mmHg with the use of intravenous nitroglycerin);
6. Uncontrolled arterial hypertension;
7. acute coronary syndrome;
8. Severe left ventricular hypertrophy;
9. Congenital or acquired valvular or myocardial disease;
10. end-stage renal disease during receipt of renal replacement therapy;
11. clinically significant anemia;
12. other contraindications for vasodilators;
13. treatment with dobutamine (at a dose ≥5 μg per kilogram of body weight per minute);
14. treatment with milrinone or levosimendan within the previous 30 days.
Benefits of Hemodialysis With Citrate (ABC-treat) Study

Prospective randomized cross-over multicenter study to demonstrate the benefits of hemodialysis without acetate dialysate, with citrate.

32 weeks duration, in two phases. In the first, half of the patients started with citrate dialysate for 16 weeks and the other half with acetate dialysate, and then patients cross.

The primary objective is to analyze the effect of citrate dialysate on acid base balance decreasing chronic metabolic acidosis and avoiding / reducing post-dialytic alkalosis.

Primary objective: to analyze the effect of citrate dialysate on acid base balance decreasing chronic metabolic acidosis and avoiding / reducing post-dialytic alkalosis.

Secondary objectives:

* Evaluate the effect of dialysate on the variation of calcium pre and post-dialytic, as well as on the parathormone (PTH)
* Assess the effect of dialysate on inflammation
* Assess the effect of dialysate on the Elimination of small and medium-sized molecules
* Assess the effect of dialysate on the tolerance to the hemodialysis sessions
* Assess the effect of dialysate on nutritional parameters

Patients: Adult patients dialysed three times per week for at least 3 months will be enrolled in 12 Spanish dialysis centres. Catheter as vascular access will be excluded.

Design: prospective randomized multicenter, cross-over trial of chronic haemodialysis patients to compare the effect of citrate dialysate with acetate dialysate.

Duration of study: 32 weeks, in two phases. Randomised to 16 weeks of hemodialysis with acetate followed by 16 weeks of citrate or 16 weeks of hemodialysis with citrate followed by 16 weeks of acetate. Each patient will serve as control of itself and there will be no changes in the pattern of dialysis during the study with the exception of the dialysate, following the usual pattern of work

Eligibility Criteria:
Inclusion Criteria:

* Outpatient conventional hemodialysis three times per week for at least three months.
* Arteriovenous fistula as vascular access
* Patients who have given their informed consent in writing.

Exclusion Criteria:

* Catheter as vascular access
* Allergy or intolerance to citrate
* Patients with sufficient cognitive impairment that would prevent the compression of information and informed consent.
* Inflammatory intercurrent diseases (chronic infections, autoimmune diseases or tumors) that can mask the results of the study.
LPS Flex Porous Femoral Components

This is a prospective multicenter study of the LPS-Flex Porous Femoral Components when used in primary total knee arthroplasty. The purpose of the study is to obtain short-, mid-, and long-term clinical outcomes and implant survivorship data for the NexGen LPS-Flex Porous Femoral components.

Survival and outcome data on the NexGen LPS-Flex Porous Femoral Components will be done by an analysis of standard scoring system, radiographs and adverse event records. Survivorship will be evaluated by monitoring the frequency and incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, and unanticipated adverse device effects. Outcomes will be measured by comparing the overall pain and function performances (based on the Knee Society Scoring System), survivorship, subject quality of life and radiographic parameters of study subjects receiving the LPS-Flex Porous Femoral Components.

Eligibility Criteria:
Inclusion Criteria:

* Patient 18-75 years of age, inclusive;
* Patient qualifies for a total knee arthroplasty based on physical exam and medical history including at least one of the following: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle;
* Post-Traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
* Moderate valgus, varus, or flexion deformities;
* Patient has undergone a study related informed consent process;
* Patient is willing and able to provide written consent;
* Patient is willing and able to cooperate in the required post-operative therapy;
* Patient is willing and able to complete scheduled follow-up evaluations.

Exclusion Criteria:

* Patient has previous history of infection in the affected joint and/or a local or systemic infection that could affect the prosthetic joint;
* Insufficient bone stock on femoral or tibial surfaces;
* Skeletal immaturity;
* Neuropathic arthropathy;
* Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb;
* Stable, painless arthrodesis in a satisfactory functional position;
* Severe instability secondary to the absence of collateral ligament integrity;
* Patient has rheumatoid arthritis and an ulcer of the skin or a history of recurrent breakdown of the skin because of their risk of postoperative infection is greater;
* Patient has a known sensitivity or allergy to one or more of the implanted materials;
* Patient is pregnant or considered a member of a protected population (e.g., prisoner, mental incompetence, unable to understand what clinical trial participation entails, etc.)
Preventing Diabetes in the Deep South: Extending Partnerships and Adapting Interventions to Reach Rural Communities at High Risk.

Diabetes is responsible for a huge and growing burden of patient suffering and social costs, and the impact of this disease is shared disproportionately by minorities and in rural resource-challenged communities, particularly in the Deep South. To address this problem, the University of Alabama (UAB) Diabetes Research Center (DRC) will establish a primary care clinical network in rural counties of Alabama and in the Mississippi delta that will provide the (DRC) and its members with opportunities for partnership and the infrastructure to conduct translational and clinical research in those patients with the greatest need. A pilot trial will be conducted within the coalition to assess feasibility for a larger trial to evaluate a novel and sustainable approach for diabetes prevention that involves an innovative lifestyle intervention combined with metformin.

The pilot trial in aim three will include enrolling four primary care practices. Each of the participating practices will be randomized to one of two arms and accordingly enrolled participants from each clinic will be assigned to one of two conditions:

Condition 1. Receive lifestyle modification alone (Diabetes Prevention Program (DPP).

Condition 2. Receive lifestyle modification (DPP) with metformin therapy recommendation.

Twenty five participants will be enrolled from each participating practice. Participants will be followed up for 12-14 months after recruitment.

Eligibility Criteria:
Inclusion Criteria:

* Age 19 to 65 years
* Body mass index (BMI) ≥30
* Receives care at one of the participating primary care clinics
* HbA1c 6.0% to 6.4%
* Resides in one location at least 5 days each week
* Willing to attend group-based classes
* Willing to work with a peer advisor in-person and over the phone
* Has regular access to telephone or cellular phone
* Willing and able to use telemonitoring body weight to conduct daily self-weighing
* Estimated Glomerular Filtration Rate (eGFR) of ≥60 in their medical record within 6 months

Exclusion Criteria:

* Diabetes diagnosis or HbA1c \>6.4% or fasting glucose ≥126
* HbA1c \<6.0%
* Pregnancy or anticipating pregnancy
* Unwilling or unable to do any of the following: give informed consent, accept random assignment, allow study staff to visit them at their primary care clinic for two follow-up visits
* Likely to relocate within next 6 months and no longer be seen at clinic within the next 12 months
* Weight loss ≥5% of body weight in past 6 months (other than postpartum)
* Past bariatric surgery
* Prescription weight loss medications within the past 6 months
* eGFR \< 60 within past 6 months
* Unable to ambulate
* Have end-stage medical conditions with limited life expectancy
Fish Oil and Muscle Function

The purpose of this study is to examine the effect of omega-3 fatty acid supplementation on changes in muscle mass, muscular strength and physical function.

Loss of muscle mass is a normal consequence of aging in many older adults, worsened by chronic illness, poor appetite and diet, and reduced physical activity. The ensuing decline in physical function is a major cause of frailty, disability and death. Treatments that can reverse or reduce the age-associated loss of muscle mass are therefore much needed. Evidence is emerging that consumption of fish or fish oil derived long-chain omega-3 polyunsaturated fatty acids (LCn-3PUFA) may be important for maintenance of muscle mass and physical function throughout the life-span. However, the effect of LCn-3PUFA supplementation on muscle mass, muscle strength and overall physical function is not known. The goal of this study therefore is to determine the effect of LCn-3PUFA supplementation on muscle mass, muscle strength and physical function in older adults.

Eligibility Criteria:
Inclusion Criteria:

* Non-obese (i.e., BMI less than 35 kg/m2)
* Between 18 to 45 or between 60 and 85 y old
* Subjects who are sedentary (\<1 h of exercise/week)

Exclusion Criteria:

* Subjects with evidence of significant organ system dysfunction (e.g. diabetes, severe cardiovascular disease, hyperlipidemia, cirrhosis, hypogonadism, uncontrolled hypo- or hyperthyroidism; uncontrolled hypertension)
* Subjects with metal implants
* Subjects with iron storage disease,
* Subjects with severe ambulatory impairments,
* Individuals with cancer or cancer that has been in remission for \<5 years,
* Individuals with dementia,
* Individuals who smoke,
* Subjects who are taking medications known to affect muscle (e.g., steroids),
* Subjects who receive anticoagulant therapy.
* Subjects taking medications to control certain medical conditions (e.g., hypertension) will be included if the drug regimen has been stable for at least 6 months before entering the study and is not expected to change during the study.
* Subjects with allergies to sea food,
* Subjects who regularly consume fish oil or consume \>2 servings of fish with a high LCn-3PUFA content (e.g. salmon, mackerel, sardines, etc) per week.
* Physical performance test score less than 17 out of 36.
Predictive Value of Geriatric Oncology Screening and Geriatric Assessment in Older Patients With Solid Cancers

A Randomized Clinical Trial examining the effects of Comprehensive Geriatric Assessment as an add on to oncologic treatment. Participants included are cancer patients found eligible for oncologic treatment, age 70 or more, and screened frail with the Geriatric 8 screening tool.

This study aims to examine the effects of Comprehensive Geriatric Assessment and interventions on prognosis in the older frail cancer patient in a Randomized Clinical Trial design.

Patients screened frail with the Geriatric 8 screening tool, aged 70 or more, and found eligible for oncologic treatment, will be included. We plan to enrol a total of 322 cancer patients for 12 months. Participants will be allocated randomly to either interventional or control group.

Participants in the interventional group will be offered a Comprehensive Geriatric Assessment and intervention at the start-up of cancer treatment. The Comprehensive Geriatric Assessment will be an add on to standardized cancer treatment offered at the Oncologic Outpatient Clinic at Odense University Hospital.

Comprehensive Geriatric Assessment will be performed by a team consisting of a doctor, nurse and physiotherapist. If needed, referral to a dietician or an occupational therapist for further evaluation will be made. The health issues are assessed using validated tests based on a Danish version of the Geriatric Core Dataset (G-CODE). Follow-up on Comprehensive Geriatric Assessment is scheduled for one month after initial evaluation.

The randomized groups will be compared with respect to primary and secondary endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 70 years
* Living in the region of Southern Denmark
* Newly diagnosed solid tumours assessed eligible for antineoplastic treatment
* Vulnerable or frail (G8 ≤ 14)

Exclusion Criteria:

* Inability to speak or understand Danish
* Inability to give informed consent
* Already consulting geriatric outpatient clinic
* Already receiving active treatment for other coexisting solid tumours, haematologic cancers, or non-melanoma skin cancer or has received oncologic treatment the past year
WS®1442 in Slightly Overweight Subjects

The purpose of this study is to test:

1. Safety of 900 mg or 1800 mg of WS® 1442 per day in overweight subjects (BMI 25 to 29,9 kg/m²)
2. Pharmacodynamic effect of WS® 1442 on endothelial function versus nordic walking training in overweight subjects

60 overweight subjects with a BMI of 25 to 29,9 kg/m2 are to be included. The safety of 900 mg/1800 mg per day WS® 1442 is determined by adverse events, laboratory parameters, vital signs as well as by a treadmill test at the beginning and the end of the study. Endothelial function measured before and after two different training modalities is compared to that measured before and after intake of two different doses of WS® 1442.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* male and female subjects aged 45-75 years
* untrained
* BMI between 25 and 29,9 kg/m²
* resting blood pressure in sitting position ≤ 140/90 mmHg
* inconspicuous ergometry

Exclusion Criteria:

* pregnancy or breastfeeding
* any other current medication
* intake of other hawthorn preparation or dietary supplements with possible influence on the interpretation of study results
* any known diseases
* alcohol or drug abuse/addiction
* nicotine abuse
* any known hypersensitivity to any of the ingredients of the investigated drug
* inability or inadequate ability to write or speak German
* not-postmenopausal women: positive pregnancy test or unsafe contraception
* any urinary test finding requiring diagnostic assessment or treatment
* deformation of the 2nd to 5th finger of both hands preventing an adequate measurement of endothelial function