cyrilzakka/clinical-trials huggingface dataset:
RIAPRE - Non-interventional Registry of Anticoagulation Treatment (BI-006-IT)

RIAPRE is a non-interventional registry to be settled in Italy with the purpose of collecting data on 600 cases of high risk elective percutaneous coronary intervention (PCI) patients treated with an anticoagulation regime different from unfractionated heparin in monotherapy. About thirty catheterization laboratories will co-operate in this activity. The long term outcome of patients will be taken into consideration. The availability of these data will allow for a better understanding of the therapeutic needs in this area.


Eligibility Criteria:
Inclusion Criteria :

* Medical condition or disease to be studied: age \> 18 years.
* Patients are candidates for a PCI with a planned anticoagulation regime other than unfractionated heparin in monotherapy. Taking into consideration the national and international guidelines for this area and the registered indications of the drugs currently used for this purpose it is predicted that the patients will probably receive one of the following:

  * unfractionated heparin as an intravenous (IV) bolus followed by IV bolus + infusion of a GPI (abciximab, tirofiban or eptifibatide); or
  * bivalirudin as an IV bolus followed by IV infusion, as per the pertinent Summary of Product Characteristics (SPCs).
* Having provided an informed consent (to anonymous data treatment).
* A planned anticoagulation regime means that any candidate patient should be identified on the basis of pre-procedural factors and requested to give his/her consent before the PCI is initiated. Patients receiving bail-out GPI for intraprocedural complications should NOT be considered for the inclusion. However, a pre-included patient could receive a bail-out GPI if deemed necessary.
* The allocation of any individual patient to the category of "high risk" elective PCI will be made independently and autonomously by the caring physician. However, it is recommended to consider the suitability of patients on the basis of these indicative elements:

  * age \> 75 years.
  * known diabetes mellitus (type I or type II).
  * known renal insufficiency, i.e. serum creatinine \> 1.8 mg or glomerular filtration rate (GFR) \> 60 ml/min (calculated with the Cockroft formula).
  * multivessel or complex procedure.
  * planned stent on a bifurcation.
  * planned stent \> 6 cm long.
  * PCI on a degenerated venous bypass: in this particular case a distal protection device should always be used.
  * non ST elevation acute coronary syndrome with a PCI planned later than 72 hours after the diagnosis without clinical instability (= "cooled" non ST elevation acute coronary syndrome). This type of patient is considered to be essentially stable and his/her level of risk can be comparable to the risk of patients who are candidates for elective PCI with additional risk factors as listed above.

Exclusion Criteria:

* There will be no specific exclusion criteria other than those listed in the Summary of Product Characteristics of every individual agent.
ELR Monitoring Against Permanent Pacemaker in Atrial Fibrillation

Randomised crossover study comparing the sensitivity and specificity of 5 External loop recorders in detecting pacemaker detected Atrial fibrillation burden.

The purpose of the study is to compare the diagnostic accuracy of the ZIO xt , MoMe, TECHNOMED pocket ECG and Nuubo to the R-test, our current standard clinical practice, in detection of AF burden, in patients with history of Paroxysmal Atrial Fibrillation and have a dual chamber pacemaker or ICD in situ, with sensitivity and specificity of AF detection calculated from the implanted pacemaker monitored beat to beat holters.

Eligibility Criteria:
Inclusion Criteria:

* History of Atrial Fibrillation
* Dual chamber pacemaker with advanced holter arrhythmia diagnostics

Exclusion Criteria:

* Previous AV node ablation
The Effect of High Dose Vitamin C in Burn Patients

The purpose of this study is to see if intravenous Vitamin C will decrease the amount of IV fluids needed following burn injury in the first 48 hours.

Adequate fluid resuscitation in burn injured patients to allow adequate renal blood flow has been the hallmark of burn care in the last 50 years. The danger of exceeding the optimal intravenous fluid resuscitation has resulted in severe complications including abdominal compartment syndrome, loss of upper airway control, extremity compartment syndromes and pulmonary edema. Hig dose vitamin C infusion during the first 24 hours of burn resuscitation has been documented to decrease the overall amount of intravenous fluid needed to provide for adequate renal perfusion and hemodynamic stability in multiple animal model studies. High dose vitamin C is thought to decrease postburn microvascular protein and fluid leakage by reducing postburn lipid oxygenation caused by burn injury generated free radicals.

Eligibility Criteria:
Inclusion Criteria:

* \>/= 20% total body surface area full and partial thickness burns
* Admitted to the USAISR burn center within 10 hours post injury

Exclusion Criteria:

* Pregnant or breast feeding
* Documented preadmission or admission renal failure
* History of glucose-6-phosphate dehydrogenase deficiency, kidney stoves, gout or sickle cell
* Electrical injury
* Renal replacement of any kind\<24 hours after admission
Evaluation of Abdominal Wall Lifting During Laparoscopic Direct Trocar Insertion

In laparoscopy, over %50 of the all complications occur during establishment of the pneumoperitoneum. Lifting of the anterior abdominal wall is aimed to increase the distance between the abdominal wall and the intrabdominal structures. Elevation of the anterior abdominal wall is recommended for the access to peritoneal cavity in literatures however the benefit exactly has not proved. This study aimed to determine the distance from anterior abdominal wall to intraperitoneal structures during lifting of the abdominal wall, to represent this distance -on the average- generate the safe range whether or not and compare with this distance and patient's age, BMI and parity.

40 patients who undergoing laparoscopic surgery for various indications are enrolled in the study. The telescope is inserted at second trocar place and the distances between anterior abdominal wall and visceral organs are measured with plastic hysterometry during maximal elevation of the abdominal wall.

Eligibility Criteria:
Inclusion Criteria:

* the patients who performed laparoscopic surgery

Exclusion Criteria:

* the patients who suspected pregnancy
* large scale intrabdominal mass
Rivastigmine in Multiple Sclerosis Patients With Cognitive Impairment

This study evaluated the efficacy and safety of 10 cm² rivastigmine patch vs. placebo in cognitively impaired Multiple Sclerosis (MS) patients. Primary objective was the assessment of cognition by the Selective Reminding Test (SRT) -a subtest of the brief repeatable battery (BRB) - after titration of 4 weeks and maintenance of 12 weeks. This double-blind period was followed by a 52-week open-label treatment phase to assess long-term safety of rivastigmine patch in these patients.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent to participate in the trial
2. Males and females between 18 and 55 years of age;
3. Definite diagnosis of multiple sclerosis as defined by 2005 revised McDonald criteria
4. MS-subtype: Clinical isolated syndrome (CIS), Relapsing Remitting Multiple Sclerosis (RRMS), Secondary progressive Multiple Sclerosis (SPMS);
5. Cognitive Impairment
6. Sufficient education to read, write and communicate comprehensibly

Exclusion Criteria:

1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
2. Women who are pregnant or breast feeding or who are menstruating and capable of becoming pregnant and not practicing a medically approved method of contraception
3. With a physical or sensory disability that can subjectively prevent the patient from completing all study requirements
4. Patients suffering any other type of concomitant psychiatric and/or neurological disorder other than MS which is known to affect cognition (e.g. severe depressive symptoms, cerebrovascular diseases, epilepsy).
5. Patients suffering an acute relapse of MS in the previous 30 days (treated or not with intravenous or oral glucocorticoid regimens) prior to baseline.
6. With a history or current problem of drug-addiction and/or alcohol abuse.
7. Known or 'new' diagnosis of diabetes mellitus (if screening blood glucose is suspicious for diabetes \[≥126 mg/dL or ≥7 mmol/L if fasting and ≥200 mg/dL or 11.1 mmol/L if random testing\] a patient should be further evaluated for diabetes mellitus)
8. With a history of severe or moderate-severe cranioencephalic trauma.
9. History or presence of any intolerance or contraindication for the application of rivastigmine (or for drugs with similar chemical structures) as listed in the current Investigator's Brochure and/or SPC, i.e. severe liver insufficiency, pancreatitis, gastric ulcer, convulsions.
10. With a history in the past year or a current diagnosis of cerebrovascular disease (for instance, stroke, transient ischemic events, aneurysms).
11. Severe depressive symptoms indicated by a score of more than ≥ 14 on the MADRS at screening
12. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin

Other protocol-defined inclusion/exclusion criteria may apply
Prospective Evaluation of Elderly Deformity Surgery

As the population continues to age, the prevalence of spinal deformity surgery for older patients is increasing. Questions regarding the suitability of these patients to undergo large spinal procedures and whether the outcomes merit the risks involved are not well known.

225 subjects greater than or equal 60 years of age with moderate and severe adult spinal deformity requiring surgical correction will be enrolled in a prospective multicenter international study. Spinal deformity will be defined as any coronal or sagittal plane spinal deformity in patients who have not undergone any previous spinal surgery (with the exception of prior decompression of a maximum of 2 levels) necessitating at a minimum a 5-level spinal fusion procedure. Standard radiographs and cross sectional imaging will be performed preoperatively, postoperatively, at 24 months and 5 years after surgery. Preoperative disease specific and general health questionnaires will be completed by all patients (EQ-5D, ODI, SRS-22r, NRS for back and leg pain). Follow up visits with questionnaires will be performed at 10 weeks (± 6 weeks), 12 months (± 2 months), 24 months (± 2 months) and 5 years (±6 months) post-operatively. All treatment-related AEs will be documented.

Regression analyses will be used to evaluate the association between patient demographics, comorbidities, treatment history, spinal deformity characteristics, surgical characteristics, treatment-related AEs and pre-surgical status to self-reported and radiographic outcomes after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age 60 years or older at the time of surgery
* Diagnosis of adult spinal deformity either in the coronal or sagittal plane requiring at the minimum a 5-level spinal fusion procedure
* Ability to understand the content of the patient information / Informed Consent Form
* Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP)
* Signed and dated Institutional Review Board (IRB)/Ethics Committee (EC)-approved written informed consent
* Reconsent of patients for the 5 year follow-up if required by the IRB/EC

Exclusion Criteria:

* Any previous spinal procedure (except prior decompression of a maximum of 2 levels)
* Neurodegenerative disease or paralysis
* Unlikely to comply with follow-up
* Institutionalized individuals
* Any not medically managed severe systemic disease
* Recent history (≤ 3 months) of substance abuse (ie, recreational drugs, alcohol) or psychosocial disturbance that would preclude reliable assessment
* Prisoner
* Presence of active malignancy
* Has active, overt bacterial infection, systemic or local
* History of recent(≤ 3 months) fracture/malignancy in the spinal region
* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
Alveolar Bone Dehiscence and Fenestration Following Accelerated Maxillary Canine Retraction

Alveolar bone loss and fenestration are the most prevalent bone defects that often result in root exposure, gingival recession, and potential treatment relapse or failure. These issues present complications in orthodontic therapy. Hence, reducing the length of orthodontic therapy and minimizing the occurrence of these serious complications are highly important for orthodontic patients, particularly adults. platelet-rich plasma (PRP) injection and decortication are two promising methods for accelerated tooth movements. Thus, The aim of this study is to evaluate alveolar bone dehiscence and fenestrations after canine retraction, using alveolar decortication and PRP injection as two methods for accelerating tooth movements.


Eligibility Criteria:
Inclusion Criteria:

1. Age of the patients ranged from 16: 22 years old.
2. Malocclusion that requires extraction of the maxillary first premolar and canine retraction (e.g. class I bimaxillary dentoalveolar protrusion and class II div 1 malocclusion).
3. Maximum anchorage needed for the maxillary arch as a part of the orthodontic treatment plan.
4. Good oral hygiene and periodontal condition.

Exclusion Criteria:

1. Medically compromised patients.
2. Severe crowding in the maxillary arch.
3. Chronic intake of NSAIDs or any medication that interfere with OTM.
4. Previous orthodontic treatment.
The Value of Lateral Release in Reconstruction of the Diaphragmatic Hiatus Hernia

Patients scheduled for surgery for primary paraesophageal herniation are randomized to either conventional suturing of the crura or with the addition of lateral release.

Patient undergoing surgery for primary paraesophageal herniation, are randomized to either conventional suturing of the diaphragmatic crura only or with the addition of a diaphragmatic incision "lateral release".

The patients are examined by computed tomography before surgery and at 1 and 3 years after surgery.

SF-36 (global quality of Life instrument), GSRS (Gastrointestinal Symptoms Rating Scale), Reflux frequency issues and Watson's dysphagia score are completed before and at 3 and 6 month as well as 1 and 3 years after surgery.

Patients undergoing laparoscopic repair for paraesophageal hernia Type II-IV are eligible for inclusion in the study. Included patients will be randomized to either reconstruction of the hiatus by suturing of the crura alone or in combination with an approximately 4 cm incision of the anterior aspect of the left diaphragma "lateral release" before crural suturing. The incision will be covered with a synthetic patch after crural closure is finished. All other aspects of the surgical procedure are similar in the two groups including complete mobilization of the hernia sac before and a total fundoplication after hiatal restoration, respectively.

Eligibility Criteria:
Inclusion Criteria:

* all patients with primary hiatus hernia type II-IV who are deemed suitable for surgery

Exclusion Criteria:

* inability to understand the nature of the purpose of the study and/or to give informed consent.
* American Society of Anesthesiologists physical status-system (ASA) \>III
* Achalasia or another severe esophageal motor disorder
Effect of Midodrine on HVPG in Advanced Chronic Liver Disease

* Primary objective: HVPG response after administration of midodrine as defined by decrease in HVPG by \> 20 % from baseline or to less than equals to 12 mmHg.
* Secondary objectives: Change in HVPG, SVR, heart rate, cardiac output, cardiac index, Blood pressure (systolic, diastolic and mean).

Methodology:

Consecutive patients of chronic liver disease in the Institute (admitted or coming to OPD) as per the inclusion and exclusion criteria will be studied.

* Study Population: Patients of advanced chronic liver disease admitted or OPD patients in ILBS
* Study Design: A single arm interventional study
* Study Period: 6 months
* Inclusion Criteria: i) CLD with grade III ascites with Na \< 130 / Systolic BP \< 90 / type 2 HRS(n=30 ) (ii) ACLF (APASL criteria) with Na \< 130 / Systolic BP \< 90 / AKI (n=30)
* Exclusion Criteria: age \< 18 and \> 75, pregnancy, splanchnic venous thrombosis, HCC, HE, significant cardiopulmonary disease, uncontrolled diabetes, hypertension, intrinsic renal disease, peripheral vascular disease.
* Sample Size with justification: This is a pilot study where a total of 60 patients will be enrolled - 30 each in the two groups.
* Intervention: HVPG will be done in these patients at baseline and then after 3 hours of 10 mg of midodrine tablets.

Monitoring and assessment: Various parameters will be assessed during the procedure before and after 3 hours of midodrine such as HVPG (WHVP - FHVP), SVR, heart rate, cardiac output, cardiac index, Blood pressure (systolic, diastolic and mean), SpO2.

- Statistical Analysis: Continuous data will be represented by mean ± SD or median ± IQR. Categorical data will be represented by n = frequency (%). Categorical data will be analyzed by Chi square test or Fisher exact test as appropriate. Continuous data will be compared by using student t test or Mann Whitney test (when applicable). The change in HVPG will be analyzed by using paired t test or Wilcoxon signed rank test. The % change in the individual group will be compared to see the significance between the groups. The significance will be seen at 5%.

* Adverse Effects: same as for HVPG (mild pain / hematoma at the puncture site, transient arrhythmias). Midodrine has got good safety profile and is used in patients of advanced chronic liver disease.
* Stopping Rule of study: nil

Expected outcome of the project: If result shows that HVPG is decreased by midodrine, then it can be used in place of beta blockers when they are contraindicated or have the potential of causing adverse effects.


Eligibility Criteria:
Inclusion Criteria:

- i) CLD with grade III ascites with Na \< 130 / Systolic BP \< 90 / type 2 HRS(n=30 ) ii) ACLF (APASL criteria) with Na \< 130 / Systolic BP \< 90 / AKI (n=30)

Exclusion Criteria:

1. age \< 18 and \> 75,
2. Pregnancy,
3. Splanchnic venous thrombosis,
4. Hepatocellular Carcinoma,
5. Hepaticencephalopathy,
6. Significant cardiopulmonary disease,
7. Uncontrolled diabetes,
8. Hypertension,
9. Intrinsic renal disease,
10. Peripheral vascular disease.
Emergence of Chemotherapy Related Hyperglycemia in nOn-diabetic Patients

To assess chemotherapy related hyperglycemia in non-diabetic patients, the investigators will assess the incidence of hyperglycemia and analyze co-medications and risk factors.


Eligibility Criteria:
Inclusion Criteria:

* Patients with cancers (colorectal, breast) who treated with curative intents and ones with malignant lymphoma who are expected to achieve complete remission with chemotherapy (mainly, CHOP regimen)
* Patients without history of diabetes mellitus
* Normal glucose tolerance, as defined in the protocol

Exclusion Criteria:

* Patients with diabetes mellitus or hyperglycemia, as defined in the protocol
Tianjin University of Sport

Knee joint is one of the most important joints of the human body. It plays a vital role in basketball, football, volleyball and other sports that need to do repeated jumping and landing in high-speed sports. However, the rate of knee joint injury is high in sports, and knee joint injury often occurs in single leg landing. It is related to the decrease of flexion angle of hip and knee joint on the supporting side, the increase of extension and valgus moment, and the increase of ground reaction force. Kinesio taping has been widely used in the field of sports protection in recent years, but whether it can correct injury-related biomechanical risk factors is still controversial, and there are few studies on the timeliness changes of kinesio taping. Therefore, starting from the above concerns, this study compares the differences in biomechanical characteristics of lower limb joints in knee joints under three conditions : kinesio taping, placebo taping and no taping. At the same time, the changes of biomechanical characteristics of lower limbs before and after taping were observed in order to provide reference for the application of knee joint kinesio taping in sports injury protection.


Eligibility Criteria:
Inclusion Criteria:

* between 18-25 years old;
* BMI between 18.5-23.9kg/m2;
* no injury history or surgery history in recent six months.

Exclusion Criteria:

* kinesio taping allergy.
Biomarker 11-dh-TXB2 in Blood and Urine Samples From Patients With Prostate Cancer and Healthy Volunteers

RATIONALE: Studying samples of blood and urine from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer.

PURPOSE: This research study is looking at a biomarker, 11-dh-TXB2, in blood and urine samples from patients with prostate cancer and healthy volunteers.

OBJECTIVES:

* To identify a potential novel marker of prostate cancer in the blood and urine, 11-dh-TXB2, to be used as a screening tool for prostate cancer as well as in detection of early relapse in patients previously treated for early-stage prostate cancer.

OUTLINE: Blood and urine samples are collected and analyzed for plasma and urinary 11-dh-TXB2 levels by HPLC and tandem-mass spectrometry.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets one of the following criteria:

  * Histopathologically confirmed prostate cancer meeting 1 of the following criteria:

    * Newly diagnosed untreated disease
    * Received prior local therapy (prostatectomy, definitive radiotherapy, brachytherapy, or cryotherapy) with no evidence of disease activity (defined as serum PSA \< 0.4 ng/mL post therapy) and by imaging studies
    * Experienced biochemical failure (defined as rise in serum PSA ≥ 0.4 ng/mL post therapy)
  * Healthy volunteer (clinic patient with no history of clinically significant malignancies within the past 6 months)

PATIENT CHARACTERISTICS:

* No clinical evidence of liver cirrhosis or chronic liver disease (i.e., evidence of ascites or severe coagulopathy)
* No active prostatitis

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* More than 30 days since prior and no concurrent regular antiplatelet agents (including aspirin, anagrelide, cilastazole, clopidogrel, dipyridamole, pentoxiphylline, sulfinpyrazone, or ticlopidine)
* More than 7 days since prior and no concurrent NSAIDs (including ibuprofen, celecoxib, diclofenac, diflunisal, etodolac, fenoprofen, flurbiprofen, indomethacin, ketoprofen, meclofenamate, mefenamic acid, nabumetone, naproxen, oxaprozin, piroxicam, sulindac, or tolmetin)
Precision Immunology to Determine the Immune Response in Patients With COVID-19

To better understand the immune response to SARS-CoV-2 infection, we devised a precision immunology approach to systematically study the immune function of different patient cohorts


Eligibility Criteria:
Inclusion Criteria:

* SARS-Cov2 positive PCR

Exclusion Criteria:

* pregnancy