cyrilzakka/clinical-trials huggingface dataset:
A 2 Week, Crossover Trial of Dietary Nitrate in Chronic Obstructive Pulmonary Disease

Acute consumption of dietary nitrate (as beetroot juice) has been shown to increase exercise and decrease systemic blood pressure in multiple populations, including COPD. The chronic effect of dietary nitrate in obstructive sleep apnea syndrome (OSAS) has not been reported.

Acute consumption of dietary nitrate (as beetroot juice) has been shown to increase exercise and decrease systemic blood pressure in multiple populations, including COPD. The chronic effect of dietary nitrate in OSAS has not been reported.

The investigators hypothesize that chronic nitrate consumption might increase exercise tolerance, and exhaled NO but decrease blood pressure and have little impact on quality of life and pulmonary function.

This study is a randomized, double-blind placebo-controlled, crossover trial. At baseline, mid-point and endpoint exercise tolerance, pulmonary function, quality of life and ambulatory blood pressure will be assessed in conjunction with demographics and blood draw. After baseline measures, each subject will be randomized to consume nitrate rich beetroot juice for 14 consecutive nights when assessments will be repeated followed by 14 nights of placebo and endpoint assessments or the converse.

Eligibility Criteria:
Inclusion Criteria:

* Clinically stable,
* Diagnosed with COPD
* Ambulatory out-patients

Exclusion Criteria:

* Long term oxygen therapy
* Pulmonary hypertension
* Active cardiovascular disease
* Active skeletal conditions
* Taking vasodilators
* Diabetes mellitus
Effect of Dialectical Behavior in Patients With Bipolar Disorder

This study aims to:

• Determine the effect of implementing Dialectical Behavior Therapy on emotion regulation difficulties, distress tolerance, and social functioning among patients with bipolar disorder.

RESEARCH HYPOTHESIS Patients with bipolar disorder who are exposed to Dialectical Behavior Therapy will exhibit lower emotion regulation difficulties, distress tolerance, and higher social functioning than those who are not exposed to such training.

The researchers decided to work on a convenient sample of 30 adult patients with bipolar disorder. Dialectical behavior therapy will be applied through psychoeducation, discussion, rehearsal, and homework assignments. Four modules were administered in Mindfulness, Emotion Regulation, Emotion Regulation, and Emotion Regulation.

Eligibility Criteria:
Inclusion Criteria:1. Diagnosed with bipolar disorder for at least one month according to DSM V with no co-morbidity.

2. Their age does not exceed 60 years old. 3. Able to read and write. 4. Able \& willing to participate in the study. 5. Living in Alexandria Governorate, Egypt.

Exclusion Criteria: demonstrate severe psychopathological symptom ( i.e: patient in acute stage)

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An Extension Study to WA19977 in Patients With Active Polyarticular-Course Juvenile Idiopathic Arthritis

This long-term, interventional, open-label extension study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients from Poland and Russia with polyarticular-course juvenile idiopathic arthritis who completed the WA19977 study. Patients will receive RoActemra/Actemra 8 mg/kg every 4 weeks. The anticipated time on study treatment is 104 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Patients who completed 104 weeks of study WA19977 with at least a JIA ACR30 clinical response to RoActemra/Actemra and no serious adverse event or adverse event
* Written informed consent obtained from patient if patient is 18 years of age and older, or if under the age of 18 years from parents or legal guardian

Exclusion Criteria:

* Patient did not benefit from RoActemra/Actemra therapy in study WA19977
* Treatment with any investigational drug since the last administration of study drug in the core study WA19977
* Patients developed any other autoimmune rheumatic disease other than the permitted JIA subsets
* Any significant medical or surgical condition that would jeopardize patient's safety
* Current serious uncontrolled concomitant disease or infection
Prevention and Treatment of Immersion Pulmonary Edema

Immersion pulmonary edema (IPE) is a condition in which fluid fills the lungs during diving or swimming, particularly in cold water. Some individuals appear to be predisposed to developing IPE. DNA samples will be collected and stored, in order to compare the genetic profiles of individuals who have experienced IPE with those who have not. In a few individuals who have experienced IPE, we plan to measure the effects of cold water immersion on the blood pressure, cardiac output and the pressures in the pulmonary artery. These will be compared with similar measurements already obtained from normal individuals.

Immersion pulmonary edema (IPE) is a condition that has sudden onset in swimmers and divers, and is characterized by cough, shortness of breath, decreased blood oxygen levels, and hemoptysis. The purpose of this study is to examine the effects of cold water immersion and the dive reflex on pulmonary arterial pressure and pulmonary capillary wedge pressure in those who have already experienced IPE, as well as explore the possibility of a genetic predisposition. Healthy nonsmoking subjects who have experienced IPE will be recruited for several cold-water immersion experiments and DNA analysis. Their pulmonary arterial and pulmonary arterial wedge pressures will be measured as they undergo immersed rest and exercise trials in thermoneutral and cold water. If the pressures increase with these trials as hypothesized, the effects of sildenafil administration (a pulmonary vasodilator) will be tested during a second trial. Blood will also be drawn for DNA analysis of certain genes with possible relation to IPE. Results of these tests will be compared with those of the general population.

Eligibility Criteria:
Inclusion Criteria:

* History of immersion pulmonary edema

Exclusion Criteria:

* Coronary artery disease, cardiomyopathy, heart valve disease
Immunosuppression's Long Term Impact on Anti-tumoral Oversight in Kidney Transplantation

Cancer is a well known complication about long term transplantation. Cancer outcomes are due to the immunosuppressive treatment that prevents transplanted people from rejection. By lowering the effectiveness of the immune system, immune cells are no longer able to seek and destroy cancer cells.

The goal here is to study immunes cells population of people that were transplanted 10 years ago and are now treated either by a corticosteroid - azathioprine association, or only by cyclosporine A.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18
* Patients with kidney transplantation for 10 year
* Patients with stable renal function (less than 20% creatinine variation during the last 12 months)
* Patients treated either by a corticosteroid - azathioprine association or cyclosporine A
* Patients giving his agreement
* Patients legally free

Exclusion Criteria:

* Patients under 18
* Patients under legal protection
* Pregnant women, or of age to get pregnant
Observational Study Evaluate Pathology Practice Use Artificial Intelligence in Patient Suspected Lung and Breast Cancer

A multinational observational study to evaluate the current pathology practices and the utilization of computational pathology plus artificial intelligence algorithms in patients with suspected lung and breast cancer.

A non-interventional study evaluating samples from patients with suspected non-small lung cancer or breast cancer to describe pathology practices and to evaluate computational pathology plus artificial intelligence algorithms in Australia, Brazil, Egypt, and Kenya. Use of digital and computational Artificial intelligence pathology in countries with low and high pathologist/population ratios is critical in developing a sustainable solution. The study has two parts, the first part will focus on breast cancer, and the second part will focus on lung cancer.

The laboratories have an active digital pathology setting and evaluate samples for cancer diagnosis. The centres of lung cancer part of the study will be selected at a later stage. The study will retrospectively evaluate samples from patients who have been preliminarily diagnosed with breast or lung cancer through clinical assessments and whose samples were evaluated only by using conventional workflow.

As part of the study, computational AI pathology algorithms will be implemented in each laboratory. Two AI pathology algorithms will be used in the breast cancer part of the study. Galen™ Breast application developed by Ibex Medical Analytics will be implemented in a laboratory in Australia. MindPeak Breast, developed by MindPeak GmbH will be implemented in laboratories in Brazil, Egypt, and Kenya. After implementing computational AI pathology algorithms, 150 samples evaluated for the primary objective from each laboratory for each cancer type will be evaluated using a conventional workflow plus an AI assisted workflow with human supervision and a conventional workflow plus an AI-assisted workflow without human supervision. These evaluations will be used to analyse secondary and exploratory objectives.

Eligibility Criteria:
Inclusion Criteria:Sample from adult patients (≥ 18 years) with suspected non-small cell lung cancer or invasive breast cancer or ductal carcinoma in situ.

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Exclusion Criteria:

* Samples with the inadequate technical quality of slides (pre-analytics quality) or images, e.g., broken slides, large out-of-focus areas, slides with fixation artefacts.

  * Samples from cases that were included in the training or technical validation.
  * Sample taken by fine needle aspiration.
  * Sample sent for cytological evaluation.
Postural Tachycardia Syndrome and Vasovagal Syncope in Relation to Serum Electrolytes and Adrenal Insufficiency

The present study aims to:

1. Estimate the prevalence of Postural Tachycardia Syndrome and vasovagal syncope among adults patients attend the Internal Medicine Clinic and ICU in period from 11/2022 to 10/2023
2. Detect of causes and the relationship between POTS and vasovagal syncope and serum electrolytes, and serum cortisol.

Postural Orthostatic Tachycardia Syndrome (POTS) is a common, although not so well-known variant of cardiovascular autonomic disorder characterized by an excessive heart rate increase on standing, symptoms of orthostatic intolerance and maybe syncope.

The most common complaints are dizziness, weakness, rapid heartbeat and palpitation on standing. Moreover, patients often report physical deconditioning and reduced exercise capacity as well as headache, brain fog, dyspnea, gastrointestinal disorders and musculoskeletal pain.

The etiology of POTS is largely unknown and three main hypotheses include an autoimmune disorder, abnormally increased sympathetic activity and catecholamine excess and sympathetic denervation leading to central hypervolemia and reflex tachycardia. The diagnostic criteria of POTS in this study is increasing hear rate from supine position to active standing by \> 30 beat per minute and positive poor mans man tilt table test.

On the other hand, Vasovagal Reflex Syncope is the most frequent cause of transient loss of consciousness . The vasovagal reaction consists of vasodilatation and a heart rate decrease. During prolonged standing, this reaction is triggered by a reduction of the central blood volume because of pooling in the lower body veins, sometimes combined with other provocative factors . Patients with reflex syncope may suffer from recurrent loss of consciousness. Most of those patients also experience frequent presyncope, which can be just as incapacitating as syncope itself. Vasovagal syncope is usually not a dangerous condition, because episodes are self-limiting. However, the quality of life of patients with recurrences can be seriously affected . The rapid loss of consciousness and the possibility of trauma tax the patients sense of physical control and self-esteem.

Eligibility Criteria:
Inclusion Criteria:

1. Patient Above 18 years.
2. Patient fulfilling diagnostic criteria of POTS increase heart rate from supine position to active standing by \> 30 beat per minute within 10 minutes and positive poor mans man tilt table test.
3. Patient with History of vasovagal syncope

Exclusion Criteria:

1. Age Below 18 Yrs old
2. patient with specific cardiac diseases
3. Patient with Neurologic disorders
4. patients on drugs that affect vasomotor tone of blood vessels
Virtual Surgical Planning Systems in Mandibular Reconstruction

The purpose of this study was to evaluate the accuracy of virtual planning using customized surgical devices (VP3D) in fibula free flap mandibular reconstruction. Virtual planning was compared to postoperative scans using cephalometric and three-dimensional (3D) measurements. Operative times of both VP3D and conventional surgery groups were compared.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent fibula free flap for mandibular reconstruction
* Patient ≥18 years old
* patient alive 6 months after completion of treatment

Exclusion Criteria:

* Patient without post-operative scan evaluation
* Patient with a chirurgical contraindication
* Pregnant or nursing woman
* Adult requiring protection (guardianship, supervision)
Cheese and Human Health

The aim of this study is to examine if a diet rich in cheese will have a beneficial effect on risk markers of cardiovascular disease compared to a diet rich in butter.

The primary parameters are total cholesterol as well as LDL-, HDL cholesterol and triacylglycerol (TAG). The secondary parameters are hsCRP, markers of insulin resistance, fasting insulin and glucose (HOMA). Furthermore bloodpressure is measured.


Eligibility Criteria:
Inclusion Criteria:

* Sign written consent
* Age: 20-70
* BMI: 20-32
* Refrain from dietary supplements and blood donations prior to, and during the study

Exclusion Criteria:

* Known or suspected abuse of alcohol, drugs or medication
* Poor compliance
* Current or previously cardiovascular disease
* Diabetes Mellitus or other severe chronic disease, including severe allergies
XELOX Combined With Cadonilimab Versus XELOX as Neoadjuvant Treatment for Locally Advanced, pMMR Rectal Cancer

This is a two-arm, open label, randomized phase II clinical study. The aim is to evaluate the safety and efficacy of Cadonilimab (a PD-1/CTLA-4 bispecific antibody) combined with XELOX regimen in pMMR locally advanced rectal cancer during the perioperative period. Eligible patients will receive either Cadonilimab plus XELOX or XELOX alone for 4 cycles before and 4 cycles after surgery. The primary endpoint is the pathological complete response rate.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or pathologically confirmed rectal adenocarcinoma located within 5 to 15cm from the anus with a stage of T3-4a or N+ according to the CT or endoscope
* Mesorectal fascia uninvolved
* Sign the informed consent form
* 18 years and older
* Mismatch repair proficient determined by immunohistochemistry
* No prior treatment
* Performance status: ECOG 0-1
* Good organ function:

Blood routine: hemoglobin ≥90g/L, neutrophil ≥1.5×10\^9/L, platelet ≥100×10\^9/L; Renal function: creatinine≤1.5×upper limit of normal (UNL) or creatinine clearance ≥50ml/min; Liver function: total bilirubin (TBIL)≤1.5×upper limit of normal (UNL); ALT≤2.5×UNL, AST≤2.5×UNL; Ejection fraction at least 50% (or lower limit of normal) by echocardiogram

Exclusion Criteria:

* Other pathological category, such as squamous cancer
* Distant metastasis or peritoneum implantation
* Have received chemotherapy or radiotherapy in the past
* Known to have allergic reactions to any ingredients or excipients of experimental drugs
* Unable to swallow or under other circumstance which would drug absorption
* Other active malignant tumors, excluding those who have been disease free for more than 5 years or in situ cancer considered to have been cured by adequate treatment
* Have received colorectal cancer surgery
* Diabetes was not controlled, defined as HbA1c \> 7.5% after anti-diabetic drugs or hypertension was not controlled, defined as systolic / diastolic blood pressure \> 140 / 90 mmHg after antihypertensive drug
* Myocardial infarction, severe/unstable angina, New York Heart Association (NYHA) class III or IV congestive heart failure in the past 12 months
* Known to be infected with human immunodeficiency virus (HIV), have acquired immunodeficiency syndrome (AIDS) related diseases, have active hepatitis B or hepatitis C
* Pregnant or nursing
* May increase the risk associated with participation in the study or administration of the study drug or mental illness that may interfere with the interpretation of research results
* There are other serious diseases that the researchers believe patients cannot be included in the study
The Efficacity of Hemodiafiltration Versus Hemofiltration for Renal Insufficiency During Intensive Care

The primary objective of this study is to compare the efficacity of hemodiafiltration and hemofiltration for decreasing plasma urea at 12h among intensive care patients. Secondary objectives include comparing urea clearance, filter duration, and %down-time, between the two techniques.


Eligibility Criteria:
Inclusion Criteria:

* According to RIFLE score, patient is stage 'F'
* The patient must be insured or beneficiary of a health insurance plan
* The patient meets at least one of the following criteria:
* metabolic acidosis (pH \< 7.2), excluding keto-acidosis
* plasma urea \> 25 mmol/l
* hyper-hydration is not controlled by diuretics

Exclusion Criteria:

* Chronic, terminal renal insufficiency with dialysis
* The patient is under judicial protection, under tutorship or curatorship
* Suspect hyperkaliemia (Kaliemia \> 6.5 mmol/l with electrocardiographic effects)
* Intoxications treated via dialysis
* Pregnant, lactating, parturient women
* Medical indication for localized citrate anticoagulation
* dialysis of less than 12 h
* patient or representative refuses to participate
Trial of a New NuSmile ZR Esthetic Primary Molar Crown

The hypothesis to be tested is that NuSmile ZR esthetic primary molar crowns perform similarly to an established Stainless Steel primary molar crown (3M ESPE) for restoration of primary molar teeth.

The aim of this study is to clinically evaluate the performance of a new NuSmile ZR esthetic primary molar crown, compared with 3M ESPE Primary Stainless Steel crowns (currently the most common full coverage crown for the restoration of primary molars when a crown is necessary)in the restoration of 50 paired, prepared primary first and second molar teeth in the deciduous dentition of child patients.

Eligibility Criteria:
Inclusion Criteria:

* Be between 3 and 7 years of age
* Have a minimum of two primary molar teeth, requiring crowns
* Have a parent or guardian capable of giving written informed consent
* Have study teeth in occlusion and in contact with adjacent teeth
* Teeth to be included in the study must have adequate remaining tooth tissue for retention of the NuSmile ZR crown to allow randomization of treatments to teeth.

Exclusion Criteria:

* Tooth is considered to be within 36 months of exfoliation
* They have a severe / serious childhood illness that requires frequent hospitalization
* They have poor general health
* They have juvenile periodontitis
* Patient is unable to return for evaluations / study recalls
Observational Study of Cardiovascular Disease.

This observational study will follow participants who completed follow-up in the FOURIER OUTCOMES trial to evaluate the long-term effects of evolocumab treatment. Long-term post-trial (legacy) beneficial effects have been reported with statins, niacin, hypoglycemic therapy and fibrates. Whether similar effects are seen after LDL cholesterol (LDL-c) lowering by PCSK9 inhibition is currently unknown.

Evolocumab therapy causes a profound reduction in LDL cholesterol of approximately 60%. Statins have shown legacy effects over 5 years post-trial, including a 7% reduction in total mortality in meta-analysis and 12% reduction in coronary mortality. It would therefore be hypothesized that additional effects beyond the trial period would be conferred by previous evolocumab treatment. It is also important to assess the long-term safety of prior evolocumab treatment.


Eligibility Criteria:
Subjects who completed the FOURIER OUTCOMES trial (defined as attendance at close-out visit irrespective of treatment compliance) will be approached by FOURIER OUTCOMES site investigators and asked about their interest in taking part in this trial.
A Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients

The purpose of this study is to look at the effects of different anti-HIV drug combinations on body fat changes in HIV-positive patients who have never received anti-HIV therapy before.

Patients are randomized to receive stavudine plus lamivudine plus nelfinavir, Combivir (zidovudine plus lamivudine) plus nelfinavir, or Combivir plus abacavir. Patients are stratified into 2 groups based on their screening plasma HIV-1 RNA: (1) greater than 1,000 up to 100,000 copies/ml or (2) greater than 100,000 up to 200,000 copies/ml. Measurements and evaluations for assessment of body fat composition, virologic and immunologic outcomes, markers of alterations in carbohydrate and lipid metabolism, and safety are performed at Baseline, Weeks 4, 8, 16, 24, and every 12 weeks thereafter until Week 96 or withdrawal. In addition, health-related quality of life and health care resource utilization data are collected at specified treatment visits.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are at least 18 years old.
* Are HIV-positive.
* Have a CD4 count greater than 50 cells/mm3.
* Have a viral load greater than 1,000 copies/ml but less than 200,000 copies/ml.
* Have never received anti-HIV medications before. (However, less than 1 week of therapy with lamivudine or a protease inhibitor and less than 4 weeks of therapy with other nucleoside reverse transcriptase inhibitors \[NRTIs\] is allowed. No therapy with nonnucleoside reverse transcriptase inhibitors \[NNRTIs\] is allowed.)
* Cannot bear children or agree to use effective methods of birth control during the study. Hormonal methods of birth control (such as birth control pills) are not considered effective for this study.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have an active AIDS-defining opportunistic infection or disease that, in the doctor's opinion, would make them unable to participate.
* Are unable, in the opinion of the doctor, to follow the dosing schedule and follow-up visit schedule.
* Have a substance abuse problem that would interfere with taking the medications correctly or attending the clinic visits.
* Are enrolled in another study.
* Cannot take medications by mouth or absorb drugs.
* Have hepatitis.
* Have a serious medical condition such as diabetes, congestive heart failure, or other heart disease.
* Need chemotherapy or radiation therapy (except for local treatment of Kaposi's sarcoma).
* Are taking certain medications.
* Are pregnant or breast-feeding.