cyrilzakka/clinical-trials huggingface dataset:
Warfarin Initiation in Mechanical Mitral Valve Replacement Patients

A prospective, comparative study evaluating warfarin initiation in a dose of 3mg versus 5mg in mechanical mitral valve prostheses patients who received anticoagulation with warfarin with the use of enoxaparen as a bridging agent .Fifty patients were included and compared in terms of the primary outcome time to reach therapeutic INR range.Other outcomes includes proportion of patients who achieved the target INR of 2.0-3.0 between day 3 and day 5, total dose of enoxaparin required for bridging, safety related to both doses of anticoagulants used

Inpatients of The Cardiovascular hospital who had undergone mitral heart valve replacement with a mechanical prosthesis and commencing warfarin were eligible for inclusion. Patients were included after they had newly undergone elective surgery for implantation of mechanical mitral heart valves, had commenced on warfarin, received enoxaparin as a bridging agent and had INR monitored for a minimum of 4 consecutive days after warfarin initiation.

A total of 50 consecutive MVR patients were recruited. Each was assigned to either the group I (25 patients) or the group II (25 patients) group. All patients received the conventional postoperative treatment including: Diuretics, beta-blockers, digoxin or heart rate-regulating calcium channel blockers and anticoagulation bridging therapy using LMWH according to the European Society of Cardiology (ESC) Guidelines for the management of MVR and antibiotic for 48hour after surgery according to the investigator's hospital's antibiotic protocol.

Baseline evaluation included demographics and history taking. After obtaining the informed consent, information including age, weight, height, smoking state, and other diseases e.g. hypertension, diabetes, hyperlipidemias, etc. were documented for each patient. Medication history in details, as well as the background cardiovascular treatment was considered.

Blood samples were withdrawn from patients for evaluation of INR. Complete blood count, kidney and liver function tests were performed as part of the routine admission care.

All patients were followed up daily post operative till reaching an in range INR value. All patients were observed daily for INR values and dose adjusted accordingly and also estimation of incidence and severity of bleeding complications was done.

Eligibility Criteria:
Inclusion Criteria:

* New mechanical mitral valve prostheses patients who will receive anticoagulation with warfarin with the use of enoxaparen as a bridging agent.

Exclusion Criteria:

* Pregnant or lactating women
* Renal disorder (GFR = 45\< mL/min) or patients on renal dialysis
* Hepatic disorder (Child Pugh class B or C)
* Clinically significant active bleeding.
* Recurrent DVT or PE.
* Baseline INR \>1.2
* Asian ancestry
* Cancer
* Impaired nutritional status
* Alcohol abuse
Aeson TAH System - Post-Market Clinical Follow-up Study

The safety and performance of the Aeson TAH system have been demonstrated for the CE mark approval in December 2020. The purpose of this post-market clinical investigation is to confirm the safety, performance and effectiveness of the Aeson TAH system when used in routine care by surgeons.

The Primary objective/endpoint is survival rate on the originally implanted Aeson device at 90 days post-implant (H1 \> 64%).

The second objectives/endpoints are:

1. Confirm the performance and safety profile of the device for patients implanted with the Aeson TAH system until being transplanted:

   * Survival at 6, 12, 18, and 24-months post-implant, and total support duration before transplantation;
   * Health status change as measured by NYHA classification, 6MWT and Quality of Life Questionnaire (EQ-5D-5L);
   * Renal and hepatic function as measured by biological parameters;
   * Hemocompatibility profile measured by biological parameters and incidence of hemocompatible-related adverse events;
   * Frequency and Incidence of Serious Adverse events.
2. Assess the effectiveness of device upgrades
3. Confirm the safety profile of the device for patients after being transplanted.

   * Survival at 30 days, 6 months, and 12 months post-transplant
   * Frequency and Incidence of Serious Adverse Event of special interest as graft reject, neurological events, major bleeding.

Eligibility Criteria:
Inclusion Criteria:

* Patient is intended to receive an Aeson TAH system according to the IFU indications within standard medical practice
* Patient has provided written informed consent using the Ethics Committee approved consent form

Non-inclusion Criteria:

* Vulnerable populations who could not voluntarily consent to participate in the study
Ketamine Associated With Opioids in Refractory Cancer Pain Treatment

Long-term opioid therapy is commonly administered for the management of severe cancer pain. Increasing doses of opioids are titrated against effects until analgesia is achieved or intolerable adverse effects occur. Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has been reported to improve analgesia in patients with uncontrolled pain receiving high doses of opioids. This study aims at determining the effectiveness of ketamine as an adjuvant to opioids in relieving cancer pain.

Main objective :

To show that low analgesic doses of ketamine associated with opioids better relieve refractory cancer pain than opioids without ketamine.

Secondary objectives :

* Determine whether ketamine use allows to reduce opioid consumption
* Evaluate the adverse effects of opioids-ketamine association versus opioids-placebo.

  100 patients are expected : 50 will be treated with opioids and ketamine ; 50 will be treated with opioids and a placebo.

Treatment will be administered for 4 days. Patients will be followed-up for 5 days.

Success is defined by a decrease of the daily pain score of 50 % after 4 days. The expected rate of success in the placebo group is 10 % whereas the expected rate of success in the ketamine group is 35 %.

Primary outcome (pain score on a 11-point numerical scale) will be evaluated everyday as well as secondary outcomes (patient and clinician global impression of change, opioid consumption, adverse reactions, patient satisfaction on pain relief, sleep interference score).

Vital parameters (cardiac frequency, respiratory frequency and arterial blood pressure) will be checked everyday, many times a day : every hour for the four hours after the beginning of the treatment and then, every four hours ; every hour for the two hours following a dose shift).

Eligibility Criteria:
Inclusion Criteria:

* Hospitalised cancer patients (informed and conscious of the cancer diagnostic)
* Undergoing opioid treatment for one month at least
* Refractory pain (score higher than 5 on an 11-point numerical pain rating scale)
* Ability to score pain on a numerical pain rating scale
* Patient written agreement

Exclusion Criteria:

* Ketamine contraindications
* Methadone or other NMDA-antagonist treatment
* Karnofsky index under 10
* Pregnancy
Fenofibrate in Type 2 Diabetes

Diabetic complications affecting the eyes, kidneys, and nerves are difficult to arrest once in progress. Recent evidence that fenofibrate confers a robust yet unexpected benefit in diabetic retinopathy offers an important translational research opportunity. The investigator's global proteomic study will provide new clues as to how fenofibrate protects vulnerable tissues, and will spur discovery of targets for new therapeutic interventions.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes of at least one year's duration; stable glycemic control (no more than 1.0% change in HbA1c in the previous six months, but no limit on HbA1c)
* Triglycerides \>150 mg/dL (in the previous six months)

Exclusion Criteria:

* Previous use of Fenofibrate or other fibrates
* Pregnancy
* Active malignancy
* Recent cardiac event or congestive heart failure
* Active liver disease
* Significant renal impairment (serum creatinine \> 2mg/dl)
A Study to Evaluate Physiologic Dentin Regeneration and Safety of KH001 in the Administration of Erupted Wisdom Tooth With Dentin Caries

The purpose of this study is to evaluate physiologic dentin regeneration and safety of KH001 in the administration of erupted wisdom tooth with dentin caries

The design is a single site, double-blind, randomized study. Phase 2 study to evaluate physiologic dentin regeneration and safety of KH001. The total duration of the study will be approximately 5 to 9 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Is between 19 and 35 of age by the time of the screening
* Has signed written informed consent in the study
* Subject who either have no pain in the affected tooth, or can endure pain until the day of tooth extraction

Exclusion Criteria:

* Is allergic to the active ingredient or other ingredients used in the investigational product
* Have participated in another clinical study within 30 days from screening visit and have a history of administration/application of investigational product/device
* Is judged by the investigator as ineligible for participation for other reasens
The ITP-RITUX Cohort: Rituximab in Immune ThrombocytoPenia.

The primary purpose of the study is to describe by a prospective observational study the serious adverse events occurring in patients treated off-label by rituximab for Immune Thrombocytopenia.

Rituximab (RTX) is used in the treatment of malignant non-Hodgkin's indication for which it has been authorized since 1997 and why it is considered effective and well tolerated. Rituximab is also effective and well tolerated in combination with methotrexate in severe rheumatoid arthritis (RA) refractory to anti-TNF. To date, the RA is the only autoimmune disease in which rituximab has proven efficacy in randomized trials and has obtained authorization in this indication. There are also data from the literature, for the benefit of rituximab in other autoimmune diseases like Lupus, cryoglobulinemia associated to Hepatitis C or Sjogren's disease.

Immune Thrombocytopenia (ITP) is an autoimmune disease in which there is thrombocytopenia due in part to destruction of platelets by autoantibodies. In adults, the disease is most often chronic and in the most severe forms, the treatment of choice is splenectomy. Rituximab was suggested during chronic ITP when used with 4 weekly infusions of 375 mg/m2, 60% of patients achieve an immediate response and 30 to 40% a prolonged response. These encouraging results and the apparent good tolerance advocate for using rituximab as first-line treatment for patients refractory to splenectomy. In France, Afssaps - French Health Products Safety Agency has recently issued a temporary protocol processing to authorize rituximab in this indication. Nevertheless, many questions remain unresolved, including the tolerance of long-term treatment and the risk of late relapse in responders. This justifies the creation of this register, whose establishment is recommended by Afssaps - French Health Products Safety Agency.

Eligibility Criteria:
Inclusion Criteria:

* ITP diagnosis according to the American Society of Hematology society
* Secondary ITP if the underlying disease is an autoimmune disease(Lupus,Sjogren..)

Exclusion Criteria:

* Previous treatment by rituximab
* Secondary ITP associated to a hematologic disease (Chronic Lymphocytic Leukemia, Hodgkin Disease...)
* Secondary ITP associated to a chronic infectious disease (Hepatitis B, C, HIV)
Comparison of the Accuracy of Different Periodontal Probes for Peri-implant Pocket Registration

Various types of periodontal probes (e.g., metal probes, plastic/bendable probes, electronic periodontal probes) are used for peri-implant pocket depth registration; however, depending on the shape and size of the prosthetic restoration an accurate peri-implant pocket registration might be impeded with standard metal probes. There is currently no systematic assessment of which probe is more accurate in peri-implant pocket registration. Therefore, peri-implant pocket registration of 50 patients with a screw-retained prosthetic restoration will be recorded with 3 different periodontal probes; i.e., with a metal probe, with a plastic probe, and with an automatic periodontal probe, before and after removal of the prosthetic restoration.


Eligibility Criteria:
Inclusion Criteria:

* screw-retained prosthetic implant restoration

Exclusion Criteria:

- cemented prosthetic implant restoration
Sustained Acoustic Medicine for Osteoarthritis Pain

The purpose of this study is to compare Sustained Acoustic Medicine treatment to topical pain relief gel for the symptomatic management of osteoarthritis. The study will measure pain and function scores for patients undergoing treatment.


Eligibility Criteria:
Inclusion Criteria:

* Have physician-diagnosed mild to moderate knee, shoulder, elbow, ankle, hip, or spine osteoarthritis OA (OARSI atlas grades 1-2) or also referred to as Degenerative Joint Disease (DJD).
* Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA
* Are between 35-85 years of age
* Report a frequent pain score between 3-7 (range: 0-10) during the week preceding enrollment
* Report that knee, shoulder, elbow, ankle, hip, or spine pain negatively affects quality of life
* Are willing not to use any cream, gel, or topical solution during the administration of treatment other than the approved treatment provided to the subject at the initiation of the study
* Are deemed appropriate by their physician or by the study site physician to participate.
* Be willing and able to self-administer treatment daily within their place of residence or during normal daily activity, excluding bathing, showering, or other water activities which may result in submersion of the study device.
* Not use or initiate opioid and/or non-opioid analgesic medications.
* Be willing to discontinue any other interventional treatment modalities on the treatment area during the study period (e.g., transcutaneous electrical nerve stimulation, electronic muscle stimulation, traditional ultrasound).

Exclusion Criteria:

* Cannot successfully demonstrate the ability to put on and take off the device.
* Displays any condition which, in the judgment of the investigator, would make participation in the study unacceptable including, but not limited to, the subject's ability to understand and follow instructions.
* Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening.
* Is pregnant.
* Is a prisoner.
* Has a pacemaker.
* Has a malignancy in the treatment area.
* Has an active infection, open sores, or wounds in the treatment area.
* Has impaired sensation in the treatment area, such as caused by chemotherapy or anesthesia.
* Has a known neuropathy (disease of the brain or spinal nerves).
* Has a hereditary disposition (tendency) for excessive bleeding (hemorrhage).
* Have knee, shoulder, elbow, ankle, or hip replacement or other surgical intervention, in the affected area in the past 6 months.
* Requires oxygen support
* Has an allergy to aspirin or other NSAIDs
* Have a secondary cause of arthritis (metabolic or inflammatory)
Affection of Renal and Urinary System in IBD Patients

Detection and classification of different renal and urinary affection in patients with IBD that attended to Assist University Hospitals

Background (Research Question, Available Data from the literature, Current strategy for dealing with the problem, Rationale of the research that paves the way to the aim(s) of the work). (200-250 words max.) Inflammatory bowel disease is an idiopathic disease cause sever inflammation of GIT , presentes in ulcerative colitis or Crohn's disease occur in 6%-47%

IBD is profoundly associated with extra intestinal manifestions , Especially renal and urinary involvement occurs in 4% - 23% of patients with IBD.

Patterns of renal complications include nephrolithiasis, glomerulonephritis, amyloidosis, AKl, CKD, tubulointerstitial nephritis, asymptomatic proteinuria and hematuria; each type has specific mechanism

Nephrolithiasis is 10-100 times greater in IBD patients than general population.most common stones are calcium, oxalate and urate; Stones occur due to loss of electrolytes "Mg,k" due to diarrhea which lead to crystallization.

Glomerulonephritis pattern in IBD , is associated with IgA nephropathy, IgM nephropathy, membranous and focal segmental glomerulonephritis.

There is genetic connection between IgA nephropathy and intestinal diseases!

Secondary amyloidosis (AA-type) is a rare but serious complication of IBD.renal amyloidosis had been proven to be the most common lethal manifestion of IBD - associated amyloidosis (A), since renal involvement rapidly leads to end stage renal failure.

Sever long -standing IBD consists a predisposing factor for renal complications that occur in 4-23 % of patients So we aim to shed more light on the pathophysiology of renal damage in IBD; considering the renal manifestions and complications of IBD, it is important to emphasize the role of screening of renal function in preventing, diagnosing, and,if possible, reversing probable kidney damage.

Eligibility Criteria:
Inclusion Criteria:

* 100 patients suffering of IBD who attended to AUH either with Crohn's or ulcerative colitis with different presentation

Exclusion Criteria:

* Patients with other known cause of kidney or urinary affection as DM,HTN,APCKD, lupus nephritis,UTI.....
Application of Detecting Circulating Tumor Cells in the Accurate Treatment of Early Stage Lung Adenocarcinoma

In 2015-2016, 224,390 cases were newly diagnosed with lung cancer in USA. Of all the cases, 83% are non-small cell lung cancer (NSCLC). Currently, the 5-year survival rate of NSCLC patients is 21%, and more than 25% of early stage NSCLC patients, who have undergone surgical treatment, will have a relapse or progression.

Circulating tumor cells (CTCs), which shed from the primary tumor into the vasculature or lymphatics, can be regarded as a new prognostic factors of metastatic process. Thus far, CTCs-detection technologies can be divided into epithelial cell adhesion molecule (EpCAM)-based detection methods, e.g., the widely used CellSearch® and Adnatest®,and EpCAM-independent detection methods, e.g., ISET® and ScreenCell®. Herein, the investigators used a newly established approach, i.e., CanPatrolTM to detect CTCs in early stage lung Adenocarcinoma cases.

The investigator aim to explore whether CTCs detection prior to surgery can be contributive to the early diagnosis, or may help to predict the prognosis and guide the treatment strategy of early stage lung Adenocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

* stage I lung adenocarcinoma

Exclusion Criteria:

* cases with any new adjuvant treatment prior to surgery
Hyoscine Butyl-bromide Versus Ondansetron for Nausea and Vomiting During Cesarean Section Under Spinal Anesthesia

overall incidence of intraoperative nausea and vomiting(IONV) during regional anesthesia for cesarean section is extremely variable, up to 80 percent , depending on the anesthetic technique used (spinal, epidural or combined spinal-epidural) and on the preventive and therapeutic measures taken.1 Spinal anesthesia for CS is safe and effective; it is currently the anesthetic technique of choice for elective Cesarean delivery (CD). However, maternal hypotension associated with spinal anesthesia is one of the primary causes of intraoperative nausea and/or vomiting (IONV); this symptom is thought to be caused by cerebral and gut hypoperfusion that stimulate the vomiting centre in the brainstem and cause serotonin release, respectively.2, 3 While bolus dosing of phenylephrine effectively treats maternal hypotension, it does not prevent intraoperative maternal nausea, which may be associated with established hypotension, and this may adversely affect patient satisfaction.4, 5 However, the unopposed vagal activity that occurs with sympathetic block might be another cause of intraoperative nausea and vomiting during spinal anesthesia.6

Both scopolamine and atropine are tertiary amines, which cross the blood-brain barrier with central side effects, such as confusion, sedation, or paradoxical excitation. However, Hyoscine butyl bromide (HBB) has a quaternary ammonium structure that does not cross through the blood-brain barrier and also with lower placental transfer than atropine, making it more suitable for use in pregnancy 7, 8.

Hyoscine Butyl-bromide, also known as scopolamine butyl-bromide and sold under the brand name Buscopan.9 Despite being a quaternary ammonium compound, HBB is still capable of targeting the chemoreceptor trigger zone due to the lack of a well-developed blood-brain-barrier in the medulla oblongata, which potentiates the antiemetic effects that it produces through local action on the smooth muscle of the gastrointestinal tract.10

So, the aim of the current study is to examine the effect of prophylactic use of HBB and Ondansetron to decrease the incidence of intraoperative bradycardia and thus intraoperative nausea and vomiting in parturients undergoing CD under spinal anaesthesia.


Eligibility Criteria:
Inclusion Criteria:

* All patients 18-40 years of age,
* American Society of Anaesthesiologists (ASA) classification class I and II
* patients scheduled for elective or semi-elective surgery (category 3 and 4 Caesarean section) under spinal anaesthesia
* Single baby pregnancy of more than 32 weeks

Exclusion Criteria:

* height \< 150 or \> 180 cm,
* Body mass index (BMI) \>35 kg m-2,
* Contraindication or refusal to undergo regional anaesthesia,
* any cardiovascular disease including arrhythmias, Patients on β-adrenergic blockers or any drugs that may alter the normal response to the study drug,
* history of PONV or motion sickness,
* had taken antiemetic medication in the previous week,
* had a history of hyperemesis gravidarum