cyrilzakka/clinical-trials huggingface dataset:
Metabolic and Cardiovascular Effects of Renal Denervation

Renal denervation has recently shown to improve glucose metabolism and insulin sensitivity in addition to reducing blood pressure. The mechanisms are however unclear. The investigators hypothesize that renal denervation alters adipose tissue function by reduced sympathetic outflow, measured by fat biopsies and markers of inflammation and insulin sensitivity. 15 clinical patients undergoing renal denervation are recruited to the study investigating anthropometry, peripheral blood samples, body composition, heart rate variability and subcutaneous fat biopsies at baseline and 6 months after renal denervation.

Renal denervation, a catheter-based approach to reduce renal sympathetic afferent and efferent activity has been used successfully to treat drug-resistant hypertension. Previous studies has demonstrated a reduction of muscle sympathetic nerve activity and renal and total body noradrenaline spillover. In addition, renal denervation seems to improve glucose metabolism and insulin sensitivity, representing the first potential nonpharmaceutical approach for treating insulin resistance. However, the mechanisms are unclear. There is a clear relationship between sympathetic overactivity and insulin resistance. Activation of the sympathetic nervous systems contributes to insulin resistance and metabolic disorders and insulin itself induces sympathetic overactivity. One possible explanation to improved glucose metabolism after renal denervation is altered adipose tissue function (due to the reduction in sympathetic activity). Therefore,15 individuals undergoing renal denervation are recruited. The clinical study includes anthropometry, peripheral blood samples, body composition, heart rate variability and subcutaneous fat biopsies before renal denervation and after 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Essential hypertension
* Systolic blood pressure \>160 mm Hg despite ≥3 antihypertensive drugs
* Clinical patients accepted for renal denervation

Exclusion Criteria:

* Type 1 diabetes
* Pregnancy
* Glomerular filtration rate ≤45 ml/min/1,73 m2
* Pacemaker/ICD
* Myocardial infarction/stroke the last 12 months
Patellofemoral Pain After Unicondylar Knee Arthroplasty

Unicondylar knee arthroplasty (UKA) is a proven procedure in patients suffering from unicompartmental knee osteoarthritis. Two different types of UKA design are available - both with different pros and cons. The so-called 'mobile-bearing UKA' requires the removal of an additional amount of cartilage and bone close to the implantat. It is unclear whether this is of clinical relevance.

We speculate that the amount of cartilage/bone removal is related to the clinical outcome of the UKA-surgery.

In patients receiving a mobile-bearing UKA that amount of cartilage/bone removal is measured during the surgery. The clinical success of the procedure will be determined with certain knee questionnaires (Kujala \& KOOS)preoperatively, 3 months postoperatively, 6 months postoperatively and 1 year postoperatively. Additionally, the so-called bone-remodelling around that area of resected cartilage and bone will be measured (SPECT-CT) postoperatively.

The three variables (removed amount of cartilage/bone; clinical success with regard to the questionnaires; bone remodelling) are then analyzed with statistical methods to find out potential assoziations among them.


Eligibility Criteria:
Inclusion Criteria:

- osteoarthritis or osteonecrosis in the medial or lateral tibiofemoral compartment

Exclusion Criteria:

* failed upper tibial osteotomy
* insufficiency of the collateral or anterior cruciate ligaments
* a fixed varus or valgus deformity (not passively correctable) above 15°
* a flexion deformity greater than 15°
* rheumatoid arthritis
Magnetic Resonance Imaging (MRI) of Tumor Response and Cognitive Impairment in Breast Cancer Patients Undergoing Chemotherapy

We will use magnetic resonance imaging (MRI) to investigate tumor changes in women with breast cancer who are receiving anthracycline-based systemic chemotherapy. We will also use MRI and cognitive tests to study the possible effects of chemotherapy on the brains of these women. The results will be compared to a control group of normal healthy women. We will try to determine if MRI can be used to predict tumor response and cognitive changes related to the chemotherapy.

In this work we will utilize conventional magnetic resonance imaging as well as a set of advanced magnetic resonance imaging tools to investigate changes in tumor physiology and the human brain resulting from anthracycline-based systemic chemotherapy. We will recruit up to 15 subjects diagnosed with breast cancer and preparing for an anthracycline-based systemic chemotherapy regimen. Each subject will undergo the set of MR imaging tools before therapy, after one therapy session, after four therapy sessions, and at the conclusion of therapy. Conventional MRI methods will be used to quantify tumor-response to chemotherapy for each subject. A control group of up to 15 normal subjects will also be recruited and will undergo MR brain imaging twice with a gap of 6 months between scans. All subjects will also undergo a battery of neuropsychological tests at each imaging session. The results of the neuropsychological tests will be used to quantify cognitive changes for each subject. A final analysis will determine if the advanced MR modalities can be used to predict the response of tumors or human cognition to chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Adenocarcinoma(ER+ve, PR+ve)
* Prescribed, but not yet begun, anthracycline based systemic chemotherapy
* Not prescribed Avastin
* Able to read and write in English
* Have signed informed consent

Exclusion Criteria:

* Diagnosed psychiatric disorder
* Conditions that would preclude MRI (Pacemaker, metal objects in body, claustrophobia, pregnancy, etc.)
* Serious, unstable medical or mental illness
* Medical contraindication to any study procedure
* Current alcohol or other substance use disorder (excluding nicotine)
* Have not read and signed informed consent, or do not understand its contents
Efficacy and Safety of Montelukast in Non Alcoholic Steatohepatitis (NASH)

the current study is to evaluate the efficacy and safety of Montelukast in the treatment of patients with non-alcoholic steatohepatitis (NASH).

This is a randomized, prospective placebo-controlled study that will be conducted on 44 patients who fulfill the selection criteria and will be classified randomly into two groups.

Group 1 (Control group n= 22): Patients will receive Placebo once daily at bedtime.

Group 2 (Treatment group n= 22): Patients will receive Montelukast 10 mg daily at bedtime.

The treatment duration will be 12 weeks. Patients will be recruited from National Liver Institute and Fever, Liver and GIT disease Shebin El-Kom hospital, Egypt. All participants will be informed about the nature of the study. The patients will give their informed consent.The study will be approved by Research Ethics Committee of faculty of pharmacy -Tanta University. Data of all patients will be private and confidential. Any unexpected risk will be reported to patients and ethical committee on time

Eligibility Criteria:
Inclusion Criteria:

* Adult (\>18 years) overweight/obese subjects who have persistently abnormal aminotransferase level in two separate occasions over the past six months.

NAFLD will be assumed in patients with moderately elevated aminotransferase activities (\<3x the upper limit of normal).

There is evidence of hepatic steatosis by imaging (increased liver echogenicity (bright), stronger echoes in the hepatic parenchyma, vessel blurring, and narrowing of the lumen of the hepatic veins) and there is no cause for secondary hepatic fat accumulation such as significant alcohol consumption, use of steatogenic medication or hereditary disorders. Patients with fibroscan score \>7 kPa and \<14 kPa will be included in the study.

Exclusion Criteria:

* Alcohol abusers.
* Presence of evidence for viral or autoimmune hepatitis.
* Diabetic patients.
* Patients with Wilson's disease and patients with hemochromatosis.
* Patients with decompensated liver disease.
* Patients show hypersensitivity to studied medications.
* Patients taking medication known to cause steatosis.
* Patients with other comorbid conditions that could potentially elevate transaminase, such as congestive heart failure, malignancy.
* Pregnancy and lactating women.
New Body Mass Index (BMI) Cut-offs for the Diagnosis of Obesity and Comorbidities

Obesity is a serious medical problem because it increases the risk of cardiovascular disease (CVD), type 2 diabetes mellitus, and certain forms of cancer. The definition of obesity is based on an excess of body fat, not of BMI. However, BMI is the reference used to establish a graded classification of weight relative to height. Although BMI is widely used as a simple surrogate measure of body fat and has been shown to correlate closely with adiposity, it would be more appropriate to determine body fat percentage and to use this value for classification purposes. The present study contemplates the determination of the per cent body fat with the aim of establishing new diagnostic and therapeutic criteria according to the associated comorbidities.

The prevalence of overweight and obesity has increased alarmingly in the last decades. Obesity is a serious medical problem because it increases the risk of hypertension, type 2 diabetes mellitus, coronary heart disease, sleep-breathing disorders, and certain forms of cancer. Obesity is defined medically as a state of increased adipose tissue of sufficient magnitude to produce adverse health consequences. The definition of obesity is based on an excess of body fat, not of BMI. However, BMI is the reference used to establish a graded classification of weight relative to height. Although BMI is widely used as a simple surrogate measure of body fat and has been shown to correlate closely with adiposity, it would be more appropriate to determine body fat percentage and to use this value for classification purposes. The present study contemplates the determination of the per cent body fat (by air displacement plethysmography) in more than 5,000 subjects representing the whole BMI range, with the aim of establishing new diagnostic and therapeutic criteria according to the associated comorbidities. The specific objectives are: a) To know the body fat percentage means for normal weight, overweight and obesity for both sexes. b) To know the body fat percentage means for normal weight, overweight and obesity for the different age ranges. c) To analyse the relationship between body fat percentage and BMI values in order to detect misclassified individuals. d) To establish new cut-offs for body fat percentage and the normality ranges according to its relationship with cardiovascular risk factors that could be useful in the diagnosis and therapy of obesity.

Eligibility Criteria:
Inclusion Criteria:

* BMI \>18.5
* No major organ disease unrelated to excess body weight

Exclusion Criteria:

* Pregnancy/lactation
* History of eating disorder or major psychiatric illness
Pre-phase Treatment Before R-CHOP Chemotherapy in Elderly Patients With Newly Diagnosed DLBCL

A phase 2 trial of pre-phase treatment before R-CHOP chemotherapy in elderly patients with newly diagnosed DLBCL

R-CHOP Chemotherapy Cataract treatment with anterior steroids Phenotypic effects Evaluate the felony associated with the procedure for the primary purpose. This study evaluated efficacy, treatment outcome and safety for all patients.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically the first large-scaled B-cell lymphoma patient
2. Diagnosis time 65 years old or older
3. Patients planning R-CHOP chemotherapy
4. Ann Arbor stage 2 (bulky ≥ diameter of 7cm), stage 3 or stage 4
5. The International Prognostic Index (IPI) is a high intermediate or high risk
6. Patients without prior history of lymphoma
7. The decision to participate voluntarily in this study and the written consent of the patient

Exclusion Criteria:

1. Histologic subtypes other than CD20 positive broad-band macro-B cell lymphoma
2. Large B-cell lymphoma involving the central nervous system
3. Inadequate systemic disease A. Patients with clinically significant heart disease (congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmia) or myocardial infarction within the past 6 months B. Serious neurological and psychiatric illness C. Serious active infection D. Other medical illnesses other than clinical trials
4. If the drug used in this study is allergic
5. If you do not agree to participate in the study
Proteomics in Small Cell Lung Cancer

The aim of this study is to gather insight into tumor-derived circulating extracellular vesicles-proteins in patients with newly diagnosed small cell lung cancer.

The study will include 50 patients with newly diagnosed SCLC, referred to systemic antineoplastic treatment at the Dept. of Oncology, Aalborg University Hospital and blood samples from 50 healthy blood donors.

The blood samples from SCLC patients will be collected before chemotherapy with Carboplatin and Etoposide and after 2 cycles of chemotherapy.

Imaging will be performed at the Dept. of Radiology, Aalborg University Hospital before chemotherapy and after 3 cycles of the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Written and signed informed consent
* Histopathologically and/or cytologically newly-diagnosed SCLC
* Measurable disease on CT scans
* Eligibility to receive standard chemotherapy consisting of carboplatin and etoposide

Exclusion Criteria:

* Active biopsy-verified second malignancy other than non-melanoma skin cancer or cervical carcinoma in situ
* Prior treatment for any malignant diseases other than non-melanoma skin cancer and cervical carcinoma in situ
* Concomitant anticoagulation treatment (acetylsalicylic acid and clopidogrel are allowed)
* Treatment with any other investigational agent
Effects of Oral L-Arginine on Chronic Hypertension in Pregnancy

The purpose of this study is to evaluate the effects of oral L-Arginine in pregnant women with chronic hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between 18-20 week of gestation with chronic hypertension

Exclusion Criteria:

* Maternal or fetal disease
Real Life Dosing of Remicade for Rheumatoid Arthritis in Austria Monitored Over 9 Infusions (Study P03756)(COMPLETED)

This is a prospective, open-label, 1-arm, multicenter observational study to determine the average Remicade dosage and time span between 9 infusions in subjects with rheumatoid arthritis (RA)

This study population was chosen from a non-probability sample.

Eligibility Criteria:
Inclusion Criteria:

* Severe RA (indication according to Austrian labeling).

Exclusion Criteria:

* According to Summary of Product Characteristics (SPC).
QoR-9 AS predicTor of postopErative Complications

Aim of the study is to evaluate, whether the self administered quality of recovery (QoR-9) questionnaire can predict postoperative complications after non-cardiac surgery and whether preoperative risk estimates can be improved by implementation of the QoR-9 as postoperative screening tool.

The QoR-9 as established patient-centred outcome measure, which is validated in German language, is surveyed preoperatively, as well as on postoperative day 1 and 3 after non-cardiac surgery. We showed in a pilot study that this score reveals a high sensitivity to detect patients with a disturbed health status through a detailed and time-consuming physical examination.We want to evaluate if short screening tools can be used to categorize patients with increased risk for developing postoperative complicationsTherefore, patients undergoing non-cardiac surgery are informed preoperatively about the study and written informed consent is obtained. Afterwards, the QoR-9, as well as validated preoperative risk scores are obtained. Relevant intra- and immediate postoperative factors are recorded. On postoperative day 1 and 3 patients perform the QoR-9. Postoperative complications during hospital stay are determined using the Clavien Dindo score by searching the patients 'record. After 6 months the patients are contacted via telephone and the QoR-9 is obtained. 6-months mortality is determined.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* undergoing non-cardiac surgery
* good knowledge of German language

Exclusion Criteria:

* blind
* out-patient
* pregnant
* psychiatric disturbance that preclude cooperation
* decline to participate
Boston Scientific Registry of Deep Brain Stimulation for Treatment of Essential Tremor (ET)

To compile characteristics of real-world outcomes for Boston Scientific Corporation's commercially approved Deep Brain Stimulation (DBS) Systems, when used according to the applicable Directions for Use, for the treatment of Essential Tremor.

To compile characteristics of real-world outcomes using Deep Brain Stimulation (DBS) for the treatment of Essential Tremor to add to the evidence available for treatment of ET.

Eligibility Criteria:
Inclusion Criteria:

* Meets criteria established in the locally applicable Directions for Use (DFU) for Essential Tremor
* Is at least 18 years old

Exclusion Criteria:

* Meets any contraindication in locally applicable Directions for Use
Visilizumab for Treatment of Perianal Fistulas in Crohn's Disease

The purpose of the study is to evaluate an intravenous (by injection) investigational medication to treat Crohn's disease in patients with at least one perianal fistula. The research is being conducted at up to 5 clinical research sites in the US and Europe and is open to both men and women ages 18 to 70 years old. Participants in the study will have a number of visits to a research site over a 17 month period. All study-related care and medication is provided to qualified participants at no cost: this includes all visits, examinations and laboratory work.

Visilizumab is a humanized antibody (antibodies are proteins that are normally made by the immune system to help defend the body from infections and other foreign substances) that is directed against T cells. Visilizumab selectively attacks problematic T cells and, in doing so, it may prevent them from causing inflammation. Visilizumab has also been observed to have a suppressive effect on the body's immune system (system in the body that reacts to foreign or occasionally one's own proteins).

PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.

Eligibility Criteria:
Inclusion Criteria:

* 18-70 years old
* Diagnosis of Crohn's disease with fistula
* Test negative for Clostridium difficile within 3 weeks
* Signed informed consent, including permission to use protected health information.

Exclusion Criteria:

* History of lymphoproliferative disorder or prior malignancy within 5 years or current malignancy
* Pregnant or nursing
* HIV, Hepatitis B or Hepatitis C infection
* Presence of obstructive symptoms, confirmed by endoscopy, within 6 months
* Likely to require surgery in the next 6 months
* Serious or active infections within 1 year
* Active infections that require antibiotic therapy
* Serious infections that require IV antibiotics or hospitalization within 8 weeks
* Started or changed dose of sulfasalazine, 5-aminosalicylic acid (5-ASA), antibiotics, probiotics, or topical therapies for Crohn's within 2 weeks
* Had increased dose of corticosteroids within 2 weeks
* Received a live vaccine within 6 weeks
* Received any monoclonal antibodies or investigational agents within 3 months
* Received cyclosporine or tacrolimus (FK506) within 4 weeks
* Dose change or discontinuation of 6-mercaptopurine, azathioprine, or methotrexate within 4 weeks
* Significant organ dysfunction
* History of lymphoproliferative disorder
* History of tuberculosis, mycobacterial infection, or positive chest x-ray
* History of thrombophlebitis or pulmonary embolus
* History of immune deficiency or autoimmune disorders (other than Crohn's disease)
* History of seizure with subtherapeutic levels of anticonvulsive medication within one week
Evaluation of Therapeutic Effects of Melatonin by Inhibition of NLRP3 Inflammasome in COVID19 Patients

The leading cause of death in patients with COVID19 is a severe inflammatory response caused by a cytokine storm that results in acute respiratory distress syndrome and acute pulmonary insufficiency, as well as dysfunction of several vital organs. Therefore, preventing the occurrence of uncontrolled inflammation is the main goal of the ongoing clinical trials. Chloroquine and tocilizumab, which have the best results, are also prescribed to control inflammation. But it can be said that treatments are the main source of inflammation. Inflammasome NLRP3 is one of the mechanisms involved in many severe inflammatory disorders. Inflammatory activation has already been demonstrated by many viruses. Melatonin, on the other hand, is a hormone in the body that can inhibit Inflammation NLRP3 in addition to various anti-inflammatory effects, especially after severe inflammation. Older adults with lower levels of melatonin and children with maximum levels of melatonin are the risk groups and low-risk groups for the disease, respectively. In the present study, while measuring melatonin in patients with COVID19, its effectiveness as a treatment method along with the common antiviral drug regimen in patients with severe disease will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COVID-19 based on either ground glass appearance in chest CT scan or positive RT-PCR test for COVID-19
* Oxygen saturation drop below 93%
* Systolic blood pressure drop below 100 or blood pressure drop of 30 mm Hg from the patient's previous normal systolic blood pressure
* Fever
* Dry cough
* Positive PCR for COVID-19
* Laboratory indices include CRP and ESR indicating COVID-19

Exclusion Criteria:

* Patient dissatisfaction
* Existence of drug interactions
* Lack of proper conditions for receiving medication
Post-acute Multicomponent Frailty Intervention

The goal is to test feasibility of a frailty intervention, including exercises and nutritional supplementation.

The frailty intervention includes frequent short exercise sessions incorporating balance, resistance training, and walking to accommodate diminished endurance, with synergistic protein and nutritional supplementation, delivered on top of usual care in the post-acute Skilled Nursing Facility (SNF) setting. There is no control group.

Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling before hospitalization
* Age ≥ 65 years
* Admitted to SNF directly from inpatient hospitalization
* English speaking
* Mild Frailty or worse, as measured by a Clinical Frailty Scale

Exclusion Criteria:

* Discharged from Emergency Department
* Non-community discharge plan on admission (e.g. plan to discharge to hospice)
* Nothing per oral (NPO) dietary status
* Presence of any feeding tube
* Chronic kidney disease stage IV or worse
* Clinician refusal
* Inability or refusal to consume intervention products (e.g. allergies to protein supplement)
* Inability to consent to study procedures
The Combined Effect of 2,3-Dimercaptosuccinic Acid and Multi-Nutrients on Children in Lead Poisoning

Lead poisoning remains a common disease among children despite successful public health efforts that reduced its prevalence.Our study was designed to test the hypothesis that lead-poisoning children (BLLs:100-440µg/L) who were given DMSA and multi-nutrients would have a greater fall than children of other groups at 12 weeks of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Initial BLLs 100-440µg/L
* Age 3-6y
* No more than two main residences
* House cleaned (no lead contaminated)
* Normal intake history and physical

Exclusion Criteria:

* Chelation in the past 12 weeks
* Concomitant Fe deficiency(ferritin\<16ng/ml)
* Hemoglobin\<10.5g/dL
* Medications affecting mineral metabolism