cyrilzakka/clinical-trials huggingface dataset:
Bicarbonate and Lipocalin in Systemic Inflammatory Response Syndrome (SIRS) Study

The investigators will determine the feasibility, safety and efficacy of intravenous sodium bicarbonate in reducing progression to overt acute renal failure in patients with the systemic inflammatory response syndrome, and low urine output or early acute renal impairment as defined by serum neutrophil gelatinase-associated lipocalin (NGAL).

The investigators hypothesise:

1. In patients with SIRS and oliguria the early administration of sodium bicarbonate or sodium chloride (control) triggered by an abnormally high NGAL level is feasible.
2. In patients with SIRS and oliguria the early administration of sodium bicarbonate or sodium chloride (control) triggered by an abnormally high NGAL level is safe.
3. In patients with SIRS and oliguria the early administration of sodium bicarbonate or sodium chloride (control) triggered by an abnormally high NGAL level leads to signs or trends of efficacy as measured by serum creatinine derived indices.

Eligibility Criteria:
Inclusion Criteria:

* Consent obtained
* Diagnosis of SIRS. Requires any TWO of:

temperature \> 38°C or \< 36°C OR heart rate \> 90 beats/min OR respiratory rate \> 20 breaths/min. PaCO2 \< 32 mm Hg OR alteration of white blood cell count \> 12,000 cells/mm3, \< 4,000 cells/mm3, or the presence of \> 10% immature neutrophils

* elevated lipocalin level
* Arterial line already in place
* Central venous catheter already in place
* Age ≥ 18 years
* Within 24 hours of admission to the ICU

Exclusion Criteria:

* Unlikely to remain in ICU for \>72 hours
* Moribund patient
* Pre-existing CKD, transplant or ESRD
* Receiving (or about to receive) continuous renal replacement therapy for acute renal failure at time of enrolment
* Diagnosis of acute GN, AIN, vasculitis or post-renal aetiology
* Known/suspected study allergy to sodium bicarbonate
* Enrolling physician concern about patient enrolment
Predictive Value of Baseline CTQ-SSS Scores for Progression to Carpal Tunnel Release Surgery: A Cohort Study

This study aims to determine the predictive value of baseline CTQ-SSS scores for progression to carpal tunnel release (CTR) surgery in patients with carpal tunnel syndrome (CTS). It will be a prospective cohort study involving at least 200 patients with CTS who are undergoing nonsurgical management. Participants will complete the CTQ-SSS and other functional measures at baseline, 3 months, 6 months, and 12 months, and the primary outcome will be progression to CTR surgery. Logistic regression models will be used to assess the predictive value of baseline CTQ-SSS scores for progression to CTR surgery, adjusting for potential confounding factors such as age, sex, and baseline symptom severity. The results of this study can help clinicians identify patients who may benefit from early surgical intervention.


Eligibility Criteria:
Inclusion Criteria:

* Patients with symptoms consistent with carpal tunnel syndrome, such as numbness, tingling, or pain in the hand or wrist.
* Patients with a positive nerve conduction study confirming carpal tunnel syndrome, OR patients with clinical symptoms and signs consistent with carpal tunnel syndrome if a nerve conduction study is not available or inconclusive.
* Patients who have not undergone hand or wrist surgery within the past 6 months.
* Patients who are 18 years of age or older.
* Patients who are willing and able to provide informed consent and comply with study requirements.

Exclusion Criteria:

* Patients with a history of hand or wrist surgery within the past 6 months.
* Patients with severe hand or wrist pain that would prevent completion of the outcome measures or interfere with their ability to participate in the study.
* Patients with severe cognitive impairment or language barrier that would prevent understanding of the study instructions or interfere with their ability to participate in the study.
* Patients with other neurologic or musculoskeletal disorders that could affect hand function or interfere with test completion.
* Pregnant or breastfeeding women.
* Patients who have participated in another clinical trial within the past 30 days.
A Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic Migraine

This is a phase 2, double-blind, randomized, multicenter, placebo-controlled, three arm parallel study to evaluate the efficacy and safety of two different dosages (30 IU daily and 60 IU daily) of TNX-1900 in patients with chronic migraine.


Eligibility Criteria:
Major Inclusion Criteria:

* Men and women aged 18 to 65 years, inclusive, at the time of Visit 1.
* History of migraine with or without aura for at least 1 year and onset at \< 50 years of age. Patient must also have a history of chronic migraine \> 3 months prior to Visit 1 as defined by IHS ICHD-3
* Patients can be on stable ≤ 1 preventive medication and any number of abortive migraine medications for 90 days prior to Screening and during the study. All treatments, other than the study drug, thought to have preventive efficacy in migraine should not be started or discontinued during the entire study period. Note: Up to approximately 30% of the patients randomized into the study can be on 1 preventative medication. Once this category is filled, only patients who are not on any preventative medications can be randomized into the study.

Major Exclusion Criteria:

* History of cluster headache.
* Presence of headaches more than 26 days a month on average for the 6 months prior to Screening.
* Failed to benefit from an adequate dose and duration, in the investigator's judgment (eg, one month of β-blocker), of 3 or more migraine preventive medications.
* Use of opiates or barbiturates more than 4 days per month for more than 3 consecutive months prior to Visit 1 and during the study.
* Use of over-the-counter (OTC) nasal products (ie, saline spray, Neti-Pot, Naväge® etc.) during the study.
* Any use of intranasal corticosteroid medications or conditions in which use of intranasal corticosteroids may be indicated during the study, eg, unstable allergic rhinitis that has previously required intranasal corticosteroids. Intranasal corticosteroid use is not allowed within 28 days of Baseline/Randomization/Visit 2 and during the treatment phase or follow-up period of the study.
* Patients who recently discontinued treatment with an anti-calcitonin-gene-related peptide (CGRP) or participated in anti-CGRP clinical study must be at least 4 months from the last drug administration prior to Visit 1.
Pulmonary Rehabilitation to Improve Physical Capacity After Pulmonary Embolism

This project aims to evaluate a rehabilitation program as treatment and uncover potential pathophysiological mechanisms of a newly identified chronic condition named "Post Pulmonary Embolism Syndrome" (PPS).

The newly identified Post Pulmonary Embolism Syndrome (PPS) is characterized by chronic persistent, but unexplained dyspnea (i.e. without signs of pulmonary hypertension or pulmonary abnormality). Symptoms are considerable, but less severe than in CTEPH patients. A recent study performed by our group confirmed that up to 50% of our patients complained of various grades of persistent unexplained dyspnea 1-10 years after the diagnosis of PE.

In this multifaceted project we wish to evaluate the effect of an eight week rehabilitation program led and supervised by a trained physiotherapist on exercise capacity in PPS patients. This interventional part of the study will be formed as a randomized controlled trial. Patients will be randomized to either usual care or a physiotherapist-supervised rehabilitation program.

The study also aims to explore potential underlying pathophysiological mechanisms in PPS, using state of the art methods such as cardiac magnetic resonance imaging and transthoracic echocardiography involving novel methods focusing on the right ventricle. The pathophysiological part of the study will be formed as a case control study, where post PE-patients who do not fulfill the criteria for PPS will serve as controls.

Eligibility Criteria:
Inclusion Criteria:

* Objectively diagnosed symptomatic pulmonary embolism by CTPA or high-probability scintigraphy 6 months to 6 years before inclusion
* Persistent dyspnea defined as modified Medical Research Council (mMRC) breathlessness scale \>= 1 that has appeared or worsened after the diagnosis of PE (eligibility criteria for randomization)

Exclusion Criteria:

* Significant pulmonary disease (COPD GOLD \>= 2, restrictive pulmonary disease, lung cancer or pleural disease.
* Heart failure (either HFrEF, HFmrEF or HFpEF as defined in ESC guidelines)
* Significant valvular heart disease
* Chronic thromboemboli pulmonary hypertension (CTEPH)
* Patients unfit for rehabilitation or walking tests du to old age, physical disability or disease
* Patients with a history of poor compliance or any condition that would interfere with the ability to comply with the study protocol e.g. history of drug abuse, excessive alcohol beverage consumption, cognitive dysfunction or severe psychiatric disease
* Active malignancy
* Life expectancy less than 3 months
* Pregnancy
Quality of Life in Prostate Cancer Patients

Recording cancer data in cancer registries is essential for producing reliable population-based data for service planning, monitoring and evaluation. Prostate cancer (PCa) remains the most frequent type of cancer in terms of incidence and mortality in men in the Caribbean. The quality of life PCa cohort will assess quality of life and patient outcomes in Martinique using a digital platform for patient-reported outcome measures.

The Martinique Cancer Registry database is the largest clinical database among the French population-based cancer registries in the Caribbean, including more than 38 000 cancer cases, with 1650 new cancer cases per year, including 550 new PCa cases per year (2010-2014 latest period). In 2020, follow-up will include vital status, assessment of quality of life with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) Core 30 and the Prostate cancer module QLQ-PR25. Urinary incontinence and erectile dysfunction recorded prior to treatment will be analysed 1, 3 and 5 years after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years and residing in Martinique, with prostate cancer diagnosed from 2020
* The patient has provided informed consent
* Patient with social security coverage

Exclusion Criteria:

* Refusal to participate
* Patient with a second cancer, five years after diagnosis
* Patient who could not answer the quality of life questionnaires
* Patient not fluent in French
* Person under legal protection
Compare Combined Sphincterotomy and Balloon Dilation (ESBD) Versus Standard Sphincterotomy (ES) in Removing Biliary Stones

To compare the technique of combined balloon sphincter dilation after an initial sphincterotomy and standard sphincterotomy in the endoscopic removal of large bile duct stones. The investigators hypothesize that combined balloon dilation and sphincterotomy allows for easier stone removal without added morbidities when compared to standard sphincterotomy.

Endoscopic sphincterotomy is a standard technique to enlarge the bile duct opening before stone removal during endoscopic retrograde cholangiopancreatography. However, complete sphincter ablation by endoscopic sphincterotomy is not always possible. Also, due to the tapering end of the distal duct, standard sphincterotomy may not be adequate for removal of particularly large stones. In a retrospective series by Ersoz et al, the addition of balloon dilation after sphincterotomy achieves a high stone clearance rate (89-95%). The investigators postulate that the combination of endoscopic sphincterotomy followed by balloon dilation may allow easier stone retrieval with acceptable complication rate.

Eligibility Criteria:
Inclusion Criteria:

* Patients at least 18 years old, presented to Prince of Wales Hospital for endoscopic retrograde cholangiopancreatography (ERCP) for known or suspected bile duct stones are invited to participate.
* Informed consent will be obtained before the beginning of ERCP.
* Patients are randomized to EST or ESBD after confirming the presence of bile duct stones on the initial cholangiogram

Exclusion Criteria:

* septic shock, coagulopathy (international normalized ratio \>1.3,
* partial thromboplastin time greater than twice that of control),
* platelet count \<50,000x103/uL or
* ampullary tumors
Improving Health Care in Major Depressive Disorder

This project aims to improve the health care provided to people with major depressive disorder (MDD), a disease which is a top cause of disability worldwide. One of the main obstacles to a more effective health care in these patients is represented by clinical heterogeneity, which has not completely elucidated biological correlates. Using a large sample of people with MDD already recruited (n=29,400), the investigators develop a clustering algorithm based on genetic-environmental and brain imaging predictors aimed at identifying homogeneous MDD subgroups. The researchers will then link these subgroups with relevant health outcomes, such as disease recurrency and severity, well-being and functioning, risk of psychiatric and medical comorbidities (e.g. cardiovascular disorders). Replication in independent samples already recruited(n=1380) will prove the validity of the subgroups and expand their clinical characterization. The investigators will develop a classification tool to link the individual's characteristics to the relevant health outcomes and provide corresponding clinical recommendations. The prognostic support tool will be applied to newly recruited samples, feasibility and usefulness according to clinicians's opinion will be assessed (n=120, ongoing recruitment).


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of depressive episode in Major Depressive Disorder (DSM-5);
* at least one depressive episode preceding the current one;
* aged between 18 and 65;
* score of at least 8 on the Hamilton Depression Rating Scale (HDRS);
* signature of the information form and declaration of informed consent;
* elementary school certificate (as a minimum requirement for understanding the questions presented in the tests);
* native Italian speaker (or bilingualism).

Exclusion Criteria:

* diagnosis of bipolar disorder, cyclothymic disorder, schizophrenia and other psychotic spectrum disorders, neurodevelopmental disorders;
* diagnosis of intellectual disability, epilepsy, neurodegenerative disorders;
* disorders related to the use of drugs or alcohol in the last 6 months (except nicotine and caffeine);
* pregnant or breastfeeding.
Smoking Reduction Intervention for Smokers Not Willing to Quit Smoking: a Randomised Control Trial

The aims of this study are (1) to examine the effect of smoking reduction intervention (reduction counseling and nicotine replacement therapy, NRT) (a) on smoking cessation and (b) on reducing daily cigarette consumption among smokers not willing to quit smoking but want to reduce smoking, and (2) to examine the effect of adherence intervention in producing a higher (a) adherence rate, (b) reduction rate, and (c) quit rate.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or above
* Ethnic Chinese male or female
* Smokes at least 2 cigarettes per day
* Have no intention to quit in the near future
* Intends to reduce smoking in the next 7 days
* Has no contraindication to NRT

Exclusion Criteria:

* Subjects who are psychologically or physically unable to communicate
* Children and teenagers (age below 18)
* Pregnant or intention to become pregnant within the next 6 months
* Those on regular psychotropic medications and in the presence of any serious health problems that may make them unsuitable for using NRT, such as recent stroke, palpitation, or other life threatening conditions
Intravesical Instillation of Hyaluronic Acid to Decrease Incidence of Urinary Tract Infection

Prospective trial which includes instillation of intravesical hyaluronic acid in an attempt to reduce the incidence of urinary tract infections in patients after orthotopic neobladder reconstruction.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing radical cystectomy and orthotopic neobladder reconstruction

Exclusion Criteria:

* patients \<18 years and unwilling to participate in this study
Platelet Activity in Vascular Surgery and Cardiovascular Events

Pathological and clinical studies have consistently demonstrated that abnormalities in thrombosis and hemostasis play a major role in the pathogenesis of atherosclerosis and atherothrombosis. Screening for abnormalities in thrombosis and hemostasis by measuring platelet activity, thrombin generation, and markers of coagulation have been proposed to identify individuals at high-risk for cardiovascular events, however, it remains a research tool not ready for implementation in standard care.

The proposed study will add to the growing understanding of platelet activity and markers of coagulation in cardiovascular disease; examine a comprehensive battery of platelet activity markers, thrombin generation, markers of coagulation, and inflammatory biomarkers in subjects undergoing vascular surgery; and will provide important data on the mechanism of increased platelet activity using micro RNA, RNA and DNA expression profiling. The study design is prospective and the main outcome measure is platelet activity measurements associated with short-term cardiovascular events in PAD patients

The main aim is to determine whether preoperative platelet activity measurements are independently associated with short-term cardiovascular events in Peripheral artery disease (PAD) patients undergoing open non-emergent lower extremity vascular surgery. We will characterize the platelet phenotype in 350 PAD patients before vascular surgery and use Cox proportional hazard models to determine the independent association of the platelet phenotype with risk of cardiovascular events in the first 30 days after surgery.

Blood collection at three different time points (before surgery, following surgery while still in the hospital, and at the subjects' first return visit to the vascular surgeon following surgery) will allow us to assess the dynamic change in platelet activity, coagulation and inflammation during the perioperative period. We believe that markers of clotting and bleeding will change during the course of surgery, and that some of these markers may be used to help predict the likelihood of developing a clotting or bleeding event following surgery. The long-term goal is to develop a clinically useful assessment of platelet activity, thrombin generation, coagulation and inflammation for risk stratification that may ultimately serve as a target for therapeutic intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects undergoing non emergent lower extremity revascularization
2. Use of aspirin within 48 hours prior to surgery
3. Age \> 21 years of age
4. Able and willing to provide written informed consent for the study

Exclusion Criteria:

1. Use of any therapeutic anticoagulant
2. Use of any nonsteroidal antiinflammatory drug (ibuprofen, naproxen, etc.) within 72 hours
3. Thrombocytopenia (platelet count\<100) or Thrombocytosis (platelet count\>500)
4. Anemia (hemoglobin\<9)
5. Any known hemorrhagic diathesis
A Study Comparing Modified Lund Concept and Cerebral Perfusion Pressure-targeted Therapy in Secondary Brain Ischaemia.

Secondary brain ischaemia (SBI) usually develops after aneurysmal subarachnoid haemorrhage (SAH) and severe traumatic brain injury (TBI). The current management strategies are based on intracranial pressure-targeted therapy (ICP-targeted) with cerebral microdialysis monitoring (modified Lund concept) or cerebral perfusion pressure-targeted therapy (CPP-targeted). We present a randomised controlled study to compare the two management strategies.

The hypotheses of the study were:

* SBI developed after aneurysmal SAH and severe TBI share the same crucial characteristics and any treatment applied will essentially treat the same underlying pathophysiology.
* ICP-targeted therapy with cerebral microdialysis monitoring according to the modified Lund concept is superior to CPP-targeted therapy in managing comatose patients with SBI after aneurysmal SAH and severe TBI.

Sixty comatose operated patients with SBI following aneurysmal SAH and severe TBI were randomized into ICP-targeted therapy with cerebral microdialysis monitoring and CPP-targeted therapy groups. Mortality rates in both groups were calculated and biochemical signs of cerebral ischaemia were analysed using cerebral microdialysis. Outcome for cerebral microdialysis was measured as poor outcome (Glasgow Outcome Scale score 1, 2 and 3) or good outcome (Glasgow Outcome Scale score 4 and 5).


Eligibility Criteria:
Inclusion Criteria:

* patients with subarachnoid haemorrhage who had anterior circulation aneurysm rupture only
* multiple anterior aneurysm rupture
* severe traumatic brain injury with isolated head injury and intradural focal lesions only

Exclusion Criteria:

* Glasgow Outcome Score of 3 with or without brainstem reflexes
* Significant co-morbidities
* posterior circulation aneurysm
* multisystem injuries
* diffuse axonal injuries