cyrilzakka/clinical-trials huggingface dataset:
Comparison of Telbivudine Versus Lamivudine on the Early Dynamics and Kinetics of Viral Suppression in Chronic Hepatitis B

This study examines the effect of telbivudine compared to lamivudine on the early viral kinetics in patients with chronic hepatitis B. The virus Kinetics is measured by the viral load (HBV-DNA) reduction in the serum during the first 12 weeks of therapy.


Eligibility Criteria:
Inclusion Criteria:

* Documented compensated HBeAg-positive or negative chronic hepatitis B
* Increased viral load with a concentration of serum HBV-DNA of at least 10\^4 copies/ml
* Proof of inflammatory activity in the liver: ALT ≥ 2 x ULN or histological evidence of inflammatory activity ≥ level I or fibrosis of ≥ I degrees (according to the Desmet classification)
* Negative urine pregnancy test with fertile women
* Willingness to use a recognized method of contraception
* Able to comply with study regimen and provide written informed consent

Exclusion Criteria:

* Current or previous antiviral treatment of chronic hepatitis B with Nucleus(t)id analoga
* Known hypersensitivity to lamivudine or telbivudine or any of the other components of the preparations
* Pregnant or breastfeeding women or women
* Simultaneous participation in other clinical trials or in the past three months
* Co-infected with HCV, HDV, HIV
* Other non HBV-related chronic liver disease: Autoimmune hepatitis, primary biliary cirrhosis, Hemochromatosis, alpha-1 antitrypsin deficiency, alcoholic hepatitis
* Evidence of hepatocellular carcinoma (alpha-fetoprotein levels\> 100 ng/ml)
* Active drug use, including an excessive alcohol consumption during the last 6 months before participating in the clinical trial
* Use of systemic treatment with anti-neoplastic or immunomodulatory medication within the last 6 months before participating in the clinical trial and during the duration of the clinical examination
* Lack of willingness or inability to consent in writing
* Concurrent condition likely to preclude compliance with schedule of evaluations
Opioid-free Anesthesia and Thoracoscopy Surgery

Evaluation of a service OFA (Opioid-free Anesthesia) protocol on post-operative pain of patients operated on by video-thoracoscopic carcinologic surgery by counting them to a group of patients receiving standard general anesthesia with opioid.

A service protocol based on opioid-free anesthesia in patients undergoing pulmonary carcinologic surgery under video-thoracoscopy will be evaluated.

The investigative team want to recruit 100 patients prospectively. These patients will be randomly assigned on the day of surgery between OFA (Opioid Free Anesthesia) and OBA (Opioid Based Anesthesia).

Anesthesia and analgesia of patients in the OFA group will be performed without morphine according to the validated local protocol. We will use level 1 and 2 analgesics (paracetamol, NSAIDs and nefopam) associated with an erector spine block and anesthesia under propofol, dexmedetomidine and ketamine ivse.

Patients in the OBA group will have so-called "basic" anesthesia and analgesia with opioids according to usual practice.

Postoperative pain by collecting morphine consumption in the first 48 hours postoperatively between the two groups will be compared.

Chronic neuropathic postoperative pain will also be collected by a telephone questionnaire at 3 months postoperative.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Patient operated on pulmonary carcinologic surgery by thoracoscopy of a foreseeable duration greater than 2 hours

Exclusion Criteria:

* Patient with unstable unstable unstable coronary artery disease,
* Patient contraindicated for the use of dexmedetomidine: heart rate\<50 / min, High degree atrioventricular block (2 and 3) unless fitted (carrier of a pacemaker),
* Patient on beta-blocker, allergy to Dexdor®,
* Patient allergic to other drugs used in OFA (Paracetamol and NSAIDs).
* Renal insufficiency patient with creatinine clearance\<30ml/min will not be excluded but will not receive NSAIDs.
* Minor patient,
* Adult patient under guardianship or curators.
Development of Volatile Organic Compounds (VOC) Analysis as a Potential Diagnostic for Infected and Non-Healing Wounds

The study aims to assess the feasibility of detecting volatile organic compounds (VOCs) from pilonidal wound dressings to assemble a VOC profile for the assessment of wound healing trends.

Non-healing wounds (NHWs) pose a significant burden to healthcare providers and to affected patients. Difficulties arise in the identification of wounds which are not on a healing trajectory. Early identification allows for proactive management to try and reduce healing time. Recent studies indicate that wound VOCs may have the potential to differentiate between healing and non-healing wounds. This study will use pilonidal abscesses for the analysis of wound VOC profiles using a non-invasive technique.

Non-healing wounds (NHWs) are a worldwide and costly problem. Although NHWs are relatively small in number, the cost associated for care and product use is disproportionately high. A recent study from the United Kingdom suggests that wound care accounts for an estimated £8.3bn, or approximately 5.5% of total NHS healthcare costs (Guest 2017). NHWs can cause pain, stress, isolation, odour, and decreased mobility for the patients and, if the wound remains after more than 12-24 months, further surgery is required which may be radical and disfiguring.

Emergency presentation of pilonidal abscess requires hospitalisation with incision and drainage of the abscess cavity. Complete healing occurs in 60% of patients (Deans GT 1998) and one in five patients represent with recurrent symptoms following emergency surgery (Jensen 1988). Infection and wound breakdown after elective surgery is also relatively common affecting 10-15% of patients (Spivak H 1996), making it a good candidate to studying non-healing wounds.

Patients over the age of 18 who are admitted to hospital with a pilonidal abscess which requires drainage will be eligible for the study. The patient will undergo the standard procedure to drain an abscess, during which time wound swabs will be collected. Additional swabs will be collected for participants in this study, compared to routine care. The wound will be dressed as standard and the same dressing is applied to an area of un-affected skin on the buttock. The dressings are changed the following day, and are handled in such a way that VOC are released and captured from the dressings. These VOC will be sent for analysis using specialist equipment, which will identify VOC profiles that are unique to each sample. Participants will be followed up 30 days later after treatment to assess the wound-healing status, which will in turn be linked back to the VOC profile in order to determine whether associations can be made between the two. The study aims to recruit 12 patients over a 12 month period.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing surgery for acute pilonidal abscess
* Aged 18 or over and able to give informed consent

Exclusion Criteria:

* Patients who are unwilling or unable to provide informed consent
* Patients who are unable to speak adequate English for informed consent
M-I/E for Preventing VAP in Post-neurosurgical Patients

Ventilator-associated pneumonia (VAP) is a common infection in critically ill patients, especially those with acute brain injuries, leading to increased mortality and longer ICU stays.

The mechanical insufflation/exsufflation (M-I/E) cough assist device improves outcomes in patients with neuromuscular disorders but its effects on brain-injured patients are largely unknown.

This study is conducted at a tertiary neurosurgical medical center and consists of two substudies. The prospective physiological study assessed the impact of M-I/E on hemodynamics and ICP in mechanically ventilated neurosurgical patients. The combined retrospective-prospective clinical study was performed to investigate the efficacy of M-I/E on occurence of VAP and other clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Post-neurosurgical adult patients
* \>18years old
* Body mass index (BMI) \<35kg/m2)
* Receiving mechanical ventilation
* With arterial blood catheter for continuous pressure measurement and/or ventricular catheter drainage for ICP measurement (only for study one)

Exclusion Criteria:

* ICP \> 22cmH2O or evidence of increased ICP
* Hemodynamically unstable (SBP\< 90 or \> 160 mmHg; DBP \< 50 or \> 110 mmHg, using cardiovascular medicine to maintain pressure, or known cardiac failure)
* Patients with lung trauma, emphysema, bronchopleural fistula or risk of pneumothorax
* History of mechanical ventilation and pneumonia within 6 months before ICU admission
Risk Factors for Acute Kidney Injury in Patients Undergoing Arthroplasty

The authors aimed to determine the risk factors associated with postoperative acute kidney injury in patients undergoing total joint arthroplasty.

Aim: The primary aim of the current study is to determine the risk factors associated with postoperative acute kidney injury in patients undergoing total joint arthroplasty. Considering that this patient group is mostly composed of advanced age and comorbid patients, the secondary aim of the study is to identify risky patients with predictable risk factors and to chart a way to make preoperative optimizations of the patients before developing postoperative complications.

Materials and Methods: Patients who underwent joint arthroplasty between 2015 and 2020 in Ankara University Faculty of Medicine, Department of Orthopedics and Traumatology were included. Within the scope of the study, patients' gender, age, weight, height, body mass index values, smoking, American Society of Anesthesiologist (ASA) score, Charlson-Comorbidity Index score (CCI), type of operation, duration of surgery, presence of intraoperative hypotension, anesthesia method , diabetes, hypertension, coronary artery disease, presence of congestive heart failure, presence of preoperative anemia, preoperative uric acid and albumin level, use of nephrotoxic agents in the perioperative period, basal creatinine and glomerular filtration rate (GFR) values, platelet suspension in the perioperative period, erythrocyte suspension, Amounts of fresh frozen plasma transfusions, postoperative creatinine at 24 hours - 48 hours - discharge, GFR values and Kidney Disesae Improving Global Outcomes (KDIGO) scores, length of hospital stay and length of stay in the intensive care unit were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged above 18 years old undergoing arthroplasty surgery

Exclusion Criteria:

* Known acute renal failure or chronic renal failure
* Patients aged below 18 years old
* Patients refusing to participate to the study
The Natural History and Biological Study of Pulmonary Recurrent Respiratory Papillomatosis (pRRP)

Recurrent respiratory papillomatosis (RRP) is an orphan disease that affects approximately 20,000 people in the United States and is caused by infection with human papillomavirus (HPV) types 6 and 11. Since RRP is an orphan disease, it is an understudied disease entity with correspondingly few treatment options. The investigators hypothesize that by understanding the biology of RRP and the failed host immune responses against HPV, novel and rational therapies can be developed. This study will examine the genetic and immunologic alterations found in these rare tumors and distant metastatic involved sites (such as the lung) in patients diagnosed with RRP.

Since RRP is an orphan disease, any single institution or hospital treats a limited number of RRP patients. The primary purpose for establishing a tissue repository is to collect RRP tissue from various institutions and hospitals and to provide investigators access to a large number of RRP tissues to perform genetic and immunologic studies of these rare tumors. This is both a prospective and retrospective tissue collection repository. Tissue that will be collected will include excess fresh or archived human tissue, either normal or pathological, that was removed as part of standard of care clinical procedures and/or during procedures performed for separate research purposes, such as a therapeutic clinical trial. Prospectively collected and archived pathology samples will be obtained under informed consent from those patients who are still living. The tissue repository will be de-identified. The PI and the RRP Foundation will collaborate and serve as the gatekeepers of the repository and oversee any tissue requests. Any academic collaborator(s) or for-profit collaborator(s) can request access to the tissue specimens. The investigator or collaborators should submit a letter to express interest in obtaining tissue from the tissue repository to the RRP Foundation and the PI.

Eligibility Criteria:
Inclusion Criteria:

* History of HPV-associated Recurrent Respiratory Papillomatosis
* Has pulmonary lesions

Exclusion Criteria:

* None
Trial to Assess Lacosamide as the First add-on Anti-epileptic Drug Treatment in Patients With Partial-onset Seizures

To evaluate the efficacy and safety of oral Lacosamide as first add on treatment in subjects with uncontrolled partial-onset seizures after prior treatment with a monotherapy Antiepileptic Drug (AED) regimen compared to subjects who have received treatment with at least 2 AEDs.

The study consisted of 3 Periods: Period 1: a 1-week Screening Phase, Period 2: a 30-week Treatment Phase (consisting of a 6-week Titration Phase and a 24-week Maintenance Phase), and Period 3: a 3-week Taper/Safety Follow-Up Phase.

Eligibility Criteria:
Inclusion Criteria:

Group 1:

* Subject has a diagnosis of epilepsy with simple partial seizures (motor component) and/or complex partial seizures with or without secondary generalization
* Currently taking adequate monotherapy (defined as a single Antiepileptic Drug (AED) for at least 28 days prior to Screening) and has no history of AED polytherapy. Prior use of rescue medication (short-term intermittent use) is acceptable
* Epilepsy diagnosis should be ≤24 months at the time of the Screening Visit
* The minimum allowed seizure frequency at any time during the 12 weeks prior to the Screening Visit is ≥3 partial-onset seizures

Group 2:

* Subject has a diagnosis of epilepsy with simple partial seizures (motor component) and/or complex partial seizures with or without secondary generalization
* Currently taking 1 to 3 AEDs, and has tried at least 2 prior AED treatment regimens (concurrently or sequentially)
* Epilepsy diagnosis should be ≥5 years at the time of the Screening Visit
* The minimum allowed seizure frequency during the 12 weeks prior to the Screening Visit is ≥1 partial-onset seizure per 28 days

Exclusion Criteria:

* Previous use of Lacosamide
* History of seizure disorder characterized primarily by isolated auras
* History of primary generalized seizures
* History of status epilepticus within last 12-months
* History of cluster seizures during the 12 week period prior to Visit 1
* Nonepileptic events, including pseudoseizures that could be confused with seizure
* Lifetime history of suicide attempt or suicidal ideation in the past 6 months
* Hypersensitivity to any component of Lacosamide
* History of drug or alcohol abuse
* History of an acute or subacutely progressive Central Nervous System (CNS) disease
* Undergone cranial surgery within the last year prior to study entry
* Concomitant treatment of Felbamate or previous Felbamate therapy within the last 6 months
* Prior or concomitant Vigabatrin use
Influenza Vaccination in Bone Marrow Transplantation

The purpose of this study is to determine whether influenza vaccination protects patients who receive a certain type of bone marrow transplantation.

Patients who receive bone marrow transplantation are at high risk for complications from influenza infection. It is not whether influenza vaccination protects patients who undergo a type of bone marrow transplantation called "nonmyeloablative", or "reduced intensity" bone marrow transplantation. This study compares the response to influenza vaccination in a group of these patients to that in healthy people.

Eligibility Criteria:
Inclusion Criteria:

* Patients were included if they had received RIC allo HSCT 3 months or more prior to enrollment, and were between the age of 18 and 65 years.
* Controls were health care providers at our institution, between the ages of 18 and 65 years, who were in good health, and who are routinely offered influenza vaccination.

Exclusion Criteria:

* Patients were excluded if they failed to engraft, or had relapse of the underlying disease requiring chemotherapy or immunotherapy.
* Patients and controls were also excluded if they had history of egg allergy, acute febrile illness at the time of vaccination, or influenza-like illness within 4 weeks prior to vaccination.
Efficacy and Tolerability of Symbicort as an add-on Treatment to Spiriva Compare With Spiriva Alone in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD)

This is a multicentre study with a randomised, parallel group, open-label, 3-month phase IV design to assess the efficacy and tolerability of Symbicort as an add-on treatment to Spiriva compare with Spiriva alone in patients with severe chronic obstructive pulmonary disease (COPD).


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent
* Men or women patients ≥40 years of age
* Diagnosis of COPD with symptoms for more than 2 years and there is a history of at least one COPD exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months before Visit 2
* Forced Expiratory Volume in 1 second (FEV1) ≤50% of predicted normal value, pre-bronchodilator and Forced Expiratory Volume in 1 second (FEV1) / Forced Vital Capacity (FVC) \< 70%, pre-bronchodilator
* Total symptom score of 2 or more per day for at least half of run-in period (breathing, cough and sputum scores from the diary card) and complete morning recordings of Digital Peak Flow Meter data at least 7 out of the last 10 days of the run-in period

Exclusion Criteria:

* A history of asthma and seasonal allergic rhinitis before 40 years of age
* Patients who have experienced exacerbation of COPD requiring hospitalisation and /or emergency room treatment and/or a course of oral steroids and/or intravenous corticosteroids and/or antibiotics within 4 weeks prior to Visit 2 and/or during run-in period and also the patients who use of systemic glucocorticosteroids (GCS) within 4 weeks and/or inhaled GCS within 2 weeks prior to Visit 2 and/or during run-in period
* Patients with relevant cardiovascular disorder judged by the investigator
* Patients with glaucoma, prostatic hyperplasia or bladder-neck obstruction judged by the investigator
* Women who are pregnant, breast-feeding or of child-bearing potential judged by the investigator
Zone 2 Flexor Tendon Repair With CoNextions TR Implant System

Prospective, randomised, controlled trial of a novel implant intended for use during surgical repair of lacerated Zone 2 flexor digitorum profundus tendons.


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age
2. Willing and able to provide a signed and dated informed consent form
3. Stated willingness to comply with all study procedures
4. Available for the duration of the study
5. Have one or two fully lacerated digital FDP tendon(s), with or without a concomitant injury of the flexor digitorum superficialis, in Zone 2 of the index, middle, ring, or small finger
6. Tendon laceration occurred within the previous 14 days

Exclusion Criteria:

1. Pregnant or planning to become pregnant during the follow-up period
2. Autoimmune disorder(s)
3. Type 1 diabetes mellitus or clinical history of poorly controlled Type 2 diabetes mellitus
4. Lack of proper cutaneous coverage at repair site
5. Concomitant fracture
6. Amputated digit(s)
7. Arthritis of the hand
8. Prior hand trauma with residual impact to function
9. Congenital hand defect
10. Conditions that would affect comparative measurements in the uninjured hand
11. Tendon laceration caused by a crush injury
12. Prior sensory impairment in digits of either hand. Note: Participants with nerve injuries associated with the trauma causing the current flexor tendon injury are eligible for enrollment
13. Vascular injuries that require revascularisation procedures
14. Ischemia and/or blood supply compromise
15. Prior or current infections at or near the intended implant site
16. Active sepsis, MRSA, or other conditions that may prevent healing
17. History of foreign-body sensitivity to 316 L Stainless Steel or UHMWPE
18. Implantation of CoNextionsTR Implant would result in physical contact with other metal implants made of material other than implant grade stainless steel such as titanium, titanium alloys, cobalt chromium, or other dissimilar metals
19. Any condition(s) which, in the opinion of the investigator, may impact the participant's ability to properly follow-up or otherwise be at-risk for following protocol instructions
20. Currently participating in another clinical/device trial

    The following criteria, determined during the surgical procedure, will also cause an individual to be excluded from the study:
21. Surgical site access less than 20 mm in total or less than 10 mm on either side of intended implant site
22. Injured tendon is outside of the width range (3.0-7.0 mm) and thickness range (1.5-4.0 mm) specified for the CoNextionsTR Implant System.
A Phase I Dose Finding and Safety Study of Oral LDE225 in Children and a Phase II Portion to Assess Preliminary Efficacy in Recurrent or Refractory MB

Phase I dose-escalation study to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of LDE225 given orally on a daily dosing schedule in children with recurrent or refractory medulloblastoma, or other tumors potentially dependent on Hedgehog signaling pathway.

Phase II study is to assess preliminary efficacy in both adult and pediatric patients with recurrent or refractory MB.


Eligibility Criteria:
Inclusion Criteria:

* Phase I - Patients aged ≥12 months and \<18 years, Phase II - Patients ≥12 months
* Phase I - Histologically confirmed diagnosis of medulloblastoma, rhabdomyosarcoma, neuroblastoma, hepatoblastoma, high grade glioma, or osteosarcoma, that has progressed despite treatment with standard therapies, or for which no standard treatments are available (patients with brainstem gliomas are excluded). Phase II - Histologically confirmed diagnosis of recurrent or relapsed medulloblastoma with at least one measurable lesion.
* Performance Status: Karnofsky ≥60% for patients \>10 yrs, Lansky ≥50 for patients less than or equal to 10 yrs
* Protocol-defined renal , liver and bone marrow function
* Negative pregnancy test before starting study treatment. If of child bearing potential must use 'highly effective' methods of contraception.
* All patients must consent to provide a tumor sample

Exclusion Criteria:

* Systemic anti-cancer treatment within 2 weeks prior to first dose (6 weeks for nitrosourea, mitomycin and monoclonal antibodies).
* Focal radiotherapy within 4 weeks prior to first dose, or full spinal radiotherapy within 3 months of first dose.
* Unresolved toxicity greater than CTCAE grade 1 from previous anti-cancer therapy or radiotherapy (excluding neurotoxicity, alopecia, ototoxicity, lymphopenia or other specifications in the eligibility criteria for this study), or incomplete recovery from previous surgery, unless agreed by Novartis and the Principal Investigator (PI) and documented.
* Major surgery, serious illness or traumatic injury within 2 weeks of starting study therapy. Patients anticipated to require major surgery within the first 2 cycles of treatment.
* Patients requiring a nasogastric tube for drug administration (G-tubes are permitted)
* Impaired cardiac function
* Pregnant or breast-feeding females
* Impairment of gastrointestinal (GI) function or GI disease

Other protocol-defined inclusion/exclusion criteria may apply